Before leaving for a two week recess, the House of Representatives passed the CHOICE Arrangement Act (H.R. 3799) by a 220-209 party-line vote. The bill would codify two Trump-era regulations intended to lower the cost of employer- sponsored health insurance. The first would allow companies to offer association health plans, and the second would allow employers to provide tax-free contributions through individual coverage health reimbursement arrangements (ICHRAs) to help employees pay for health coverage in the individual market. Democrats have argued that these policies can be used by employers to discriminate against certain classes of employees. The Congressional Budget Office (CBO) estimates that the bill would add $348 million to the federal deficit over the next decade. The bill is unlikely to be taken up by the Democratic- controlled Senate. The House and Senate will return to session the week of July 10th.

Senate Appropriators Adopt 302(b) Allocations, Two FY24 Spending Bills

Senate appropriators have adopted the top-line spending levels agreed to in this year’s bipartisan debt limit deal. The Senate Appropriations Committee agreed to the subcommittee allocations for fiscal year (FY) 2024’s twelve annual appropriations bills by a 15-13 party line vote. The figures represent a $12.2 billion cut compared to FY 2023 levels, but are consistent with the debt limit agreement signed into law earlier this month. Committee Chair Patty Murray (D-Wash.), however, has stated plans to redirect unspent funds and use emergency spending to increase total spending levels. Republicans objected to the topline figures, stating that they were not consulted in the drafting of the allocations. Their Republican counterparts in the House of Representatives have opted to adopt spending levels below the ceiling agreed to in the most recent debt limit negotiations.

Senate appropriators also advanced the Agriculture- Rural Development-Food and Drug Administration (FDA) and Military Construction-Veterans Affairs (VA) appropriations bills in two 28-0 votes last week. The Agriculture-FDA bill includes $26 billion in discretionary spending, a $513 million increase in budget authority over current levels. The FDA would see a $20 million increase. The Military Construction-VA bill includes $135.3 billion in nondefense discretionary spending, a slight increase over FY 2023. VA medical care would see a $2.3 billion increase for a total of $121 billion.

EPW Leadership Requests Comments on PFAS Discussion Draft

Leadership of the Senate Enviornment and Public Works (EPW) Committee has released a bipartisan draft bill on per- and polyfluoroalkyl substances (PFAS). The legislation seeks to improve the mitigation and remediation of PFAS contamination. The legal definition of PFAS included in the bill would exclude many types of the chemicals used by the medical device industry. The panel is requesting stakeholder comments on the draft by July 3, 2023.

RSC Releases FY2024 Budget, Includes Medicare Reforms

The Republican Study Committee (RSC) released its fiscal year 2024 budget last week. The proposal, titled “Protecting America’s Economic Security,” balances the budget in seven years, cuts spending by $16.3 trillion over the next decade, and reduces taxes by $5.1 trillion over 10 years. The budget is comprised of over 220 individual bills and initiatives from RSC members, including a Medicare premium support plan that would implement a model whereby the program’s trust funds would be merged into a single fund that would pay premium subsidies to Medicare beneficiaries. The RSC budget asserts that this type of model could reduce premiums overall by 7%.

Blunt Rochester Officially Enters DE Senate Race

As expected, Rep. Lisa Blunt Rochester (D-Del.) has filed the paperwork necessary to launch a 2024 Senate campaign. Sen. Tom Carper (D-Del.) announced earlier this year that he would not seek reelection and endorsed Blunt Rochester to succeed him. If elected, she would be the first woman and first person of color to serve the state of Delaware in the Senate.

Employers Endorse Legislation to Address “Dishonest Billing”

The ERISA Industry Committee has spearheaded a letter to members of Congress signed by other business stakeholders endorsing the Facilitating Accountability in Reimbursement (FAIR) Act (H.R. 3417), and the Site-based Invoicing and Transparency Enhancement (SITE) Act (S.1869). The letter argues that the bills will help address the problem of dishonest billing, or when hospitals “secretly reclassify a doctor’s office they own as a hospital setting in order to charge more money.” The employers argue that these practices contribute to consolidation and higher prices across the health care industry. The FAIR Act, introduced by Reps. Kevin Hern (R-Okla.) and Annie Kuster (D-N.H.), aims to harmonize billing practices by ensuring all off-campus outpatient departments have separate national provider identification (NPI) numbers. It would also direct the Centers for Medicare and Medicaid Services to prioritize auditing facilities recently converted to off campus hospital outpatient departments to ensure they are meeting remote location of a hospital facility requirements. The SITE Act, introduced by Sens. Mike Braun (R-Ind.) and Maggie Hassan (D-N.H.), would end the 2015 Bipartisan Budget Act’s site-neutral exceptions, and prevent off-campus emergency departments from charging higher rates than on-campus emergency departments when standalone emergency facilities are near a hospital campus. It would also require health systems to establish and bill using a unique NPI for every off-campus outpatient department.

Upcoming Congressional Hearings and Markups

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

Recently Introduced Health Legislation

H.R.4202 – To amend title 18, United States Code, to expand to all firearms the requirement that Federal firearms licensees report sales of 2 or more handguns to the same unlicensed person within 5 consecutive business days. Sponsor: Torres, Norma J. [Rep.-D-CA-35]; Committees: House – Judiciary

H.R.4201 – To amend title 18, United States Code, to require a gun lock to be provided to every firearm purchaser. Sponsor: Tlaib, Rashida [Rep.-D-MI-12]; Committees: House – Judiciary

H.R.4195 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to allow parental choice in the selection of primary health insurance coverage or primary coverage under a group health plan for certain dependent children. Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

H.Res.522 – Recognizing the role of father engagement in improving overall health outcomes during pregnancy, birth, and postpartum, for both the mother and baby. Sponsor: Veasey, Marc A. [Rep.-D-TX-33]; Committees: House – Energy and Commerce

S.2044 – A bill to require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

S.2052 – A bill to amend title XVIII of the Social Security Act to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare part D, and for other purposes; Sponsor: Tester, Jon [Sen.-D- MT]; Committees: Senate – Finance

S.2059 – A bill to impose sanctions with respect to pharmaceutical companies of the People’s Republic of China and certain cartels that traffic fentanyl into the United States, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Banking, Housing, and Urban Affairs

H.R.4215 – To require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Veterans’ Affairs; Oversight and Accountability; Natural Resources

H.R.4223 – To establish an artificial intelligence commission, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Science, Space, and Technology

S.Res.264 – A resolution designating June 2023 as “National Post-Traumatic Stress Awareness Month” and June 27, 2023, as “National Post-Traumatic Stress Awareness Day”; Sponsor: Sullivan, Dan [Sen.-R-AK]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.2070 – A bill to prohibit the Secretary of Veterans Affairs from replacing physician anesthesiologists with certified registered nurse anesthetists under the health care system of the Department of Veterans Affairs, and for other purposes; Sponsor: Cantwell, Maria [Sen.-D-WA]; Committees: Senate – Veterans’ Affairs

S.2078 – A bill to direct the Secretary of Veterans Affairs to take actions necessary to ensure that certain individuals may update the burn pit registry with the cause of death of a registered individual, and for other purposes; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Veterans’ Affairs

POLICY BRIEFINGS
Recently Introduced Health Legislation Contd.

S.2079 – A bill to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2080 – A bill to reauthorize and improve the pilot program to support State medical stockpiles, to ensure that State, local, Tribal, and territorial public health departments or officials are consulted by the Public Health Emergency Medical Countermeasures Enterprise, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.2081 – A bill to amend section 485 of the Higher Education Act of 1965 to require venue-specific heat illness emergency action plans for any institution of higher education that is a member of an athletic association or athletic conference, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

S.2084 – A bill to direct the Secretary of Defense to establish an outreach program to inform members of the Armed Forces assigned to work near burn pits of the risks of toxic exposure, and for other purposes; Sponsor: Welch, Peter [Sen.- D-VT]; Committees: Senate – Armed Services

S.2085 – A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; Sponsor: Crapo, Mike [Sen.-R-ID]; Committees: Senate – Finance

S.2093 – A bill to establish a program at BARDA for developing medical countermeasures for viral threats with pandemic potential; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

S.2101 – A bill to provide for an earlier effective date for the requirement of Senate confirmation of the Director of the Centers for Disease Control and Prevention; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.530 – Expressing support for the designation of June 21, 2023, as National ASK (Asking Saves Kids) Day to promote children’s health and safe storage of guns in the home; Sponsor: Crow, Jason [Rep.-D-CO-6]; Committees: House – Energy and Commerce

H.R.4240 – To require that opioid overdose rescue kits be located at public elementary and secondary schools, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Education and the Workforce; Energy and Commerce

H.R.4242 – To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

H.R.4249 – To amend title 38, United States Code, to furnish hospital care and medical services to veterans and dependents who were stationed at military installations at which the veterans and dependents were exposed to perfluorooctanoic acid or other per- and polyfluoroalkyl substances, to provide for a presumption of service connection for certain veterans who were stationed at military installations at which the veterans were exposed to such substances, and for other purposes; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Veterans’ Affairs

H.R.4256 – To amend section 485 of the Higher Education Act of 1965 to require venue-specific heat illness emergency action plans for any institution of higher education that is a member of an athletic association or athletic conference, and for other purposes; Sponsor: Mfume, Kweisi [Rep.-D-MD-7]; Committees: House – Education and the Workforce

H.R.4261 – To amend titles XVIII and XIX of the Social Security Act to provide for coverage of peripheral artery disease screening tests furnished to at-risk beneficiaries under the Medicare and Medicaid programs without the imposition of cost-sharing requirements, and for other purposes; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce; Ways and Means

H.R.4262 – To direct the Secretary of Veterans Affairs to provide for the online administration of the Civilian Health and Medical Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Veterans’ Affairs

H.R.4263 – To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten- containing grain, and for other purposes; Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Energy and Commerce

H.R.4269 – To direct the Secretary of Labor to conduct a study on the effectiveness of spending by the Occupational Safety and Health Administration to provide technical assistance and compliance assistance in relation to heat-related illness; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Education and the Workforce

S.Res.270 – A resolution designating July 15, 2023, as “National Leiomyosarcoma Awareness Day”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Judiciary

S.Res.271 – A resolution designating June 15, 2023, as “World Elder Abuse Awareness Day” and the month of June as “Elder Abuse Awareness Month”; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Judiciary

S.Res.276 – A resolution expressing opposition to the use of State power against people in the United States seeking essential health care, including criminalization of the full range of sexual and reproductive health care such as abortion, gender-affirming care, and contraceptive care, and disapproving of State punishment of people for their pregnancy outcomes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.283 – A resolution recognizing June 28, 2023, as the 125th anniversary of the American Association of Colleges of Osteopathic Medicine and commending the work of the association to improve the health of the people of the United States; Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Health, Education, Labor, and Pensions

S.2107 – A bill to allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

S.2112 – A bill to make the Care Compare internet website and its data more accessible by individuals using search engines; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Finance

S.2115 – A bill to authorize the President to enter into trade agreements for the reciprocal elimination of duties or other import restrictions with respect to medical goods to contribute to the national security and public health of the United States, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

S.2117 – A bill to allow participants in the National Health Service Corps to defer their obligated service in order to receive training in palliative care services; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

S.2118 – A bill to clarify the inability of the President to declare national emergencies under the National Emergencies Act, major disasters or emergencies under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and public health emergencies under the Public Health Service Act on the premise of climate change, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Environment and Public Works

S.2119 – A bill to reauthorize the Firefighter Cancer Registry Act of 2018; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

S.2128 – A bill to amend title XIX of the Social Security Act to increase Federal Medicaid funding for States that provide intensive community-based services for adults with serious mental illness, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Finance

S.2129 – A bill to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA-PD plan under part D of the Medicare program that use a formulary to include certain drugs and biosimilar biological products on such formulary, and for other purposes; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

S.2131 – An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Heinrich, Martin [Sen.- D-NM]; Committees: Senate – Appropriations

S.2133 – A bill to amend title XVIII of the Social Security Act to establish a Medically Tailored Home-Delivered Meals Demonstration Program to test a payment and service delivery model under part A of Medicare to improve clinical health outcomes and reduce the rate of readmissions of certain individuals; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

S.2137 – A bill to amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

S.2157 – A bill to repeal prescription drug price control provisions of the Inflation Reduction Act; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Finance

S.2163 – A bill to direct the Secretary of Education to study student mental health at institutions of higher education and to issue guidance on compliance with the Americans with Disabilities Act of 1990 for mental health and substance use disorder policies of institutions of higher education, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.2164 – A bill to increase oversight and transparency with respect to Medicare billing codes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

S.2172 – A bill to amend the Internal Revenue Code of 1986 to exclude from gross income certain federally-subsidized loan repayments for dental school faculty; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

S.2183 – A bill to require the Secretary of Health and Human Services to establish an exposure registry and conduct epidemiological studies to assess health outcomes associated with the Red Hill Incident; Sponsor: Schatz, Brian [Sen.-D- HI]; Committees: Senate – Armed Services

S.2186 – A bill to require the Center for Medicare and Medicaid Innovation to test allowing blood transfusions to be paid separately from the Medicare hospice all-inclusive per diem payment; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Finance

S.2188 – A bill to increase access to pre-exposure prophylaxis to reduce the transmission of HIV; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

S.2191 – A bill to amend the Public Health Service Act to ensure the consensual donation and respectful disposition of human bodies and human body parts donated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplantation, and for other purposes; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2194 – A bill to remove limitations under Medicaid, Medicare, CHIP, and the Department of Veterans Affairs on benefits for persons in custody pending disposition of charges; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

S.2198 – A bill to require the Comptroller General of the United States to conduct a study and submit a report on price- related compensation and payment structures in the prescription drug supply chain; Sponsor: Bennet, Michael F. [Sen.-D- CO]; Committees: Senate – Finance

S.2205 – A bill to regulate human cadaveric islets for transplantation as organs; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2213 – A bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor’s background, or forthcoming survivorship needs, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

H.R.4272 – To provide public awareness and outreach regarding the dangers of fentanyl, to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program, to expand treatment and recovery services for people with opioid addictions, and to increase and to provide enhanced penalties for certain offenses involving counterfeit pills; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

H.R.4274 – To require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Science, Space, and Technology

H.R.4275 – To amend the Public Health Service Act to ensure the consensual donation and respectful disposition of human bodies and human body parts donated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplantation, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

H.R.4279 – To establish the National Commission on Critical Supply Chains, and for other purposes; Sponsor: Brown, Shontel M. [Rep.-D-OH-11]; Committees: House – Energy and Commerce

H.R.4281 – To establish the Office of Sexual and Reproductive Health and Well-Being within the Department of Health and Human Services, to generate a whole-of-government approach to protecting and affirming sexual and reproductive rights, and for other purposes; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce

H.R.4286 – To amend title XIX of the Social Security Act to require coverage under State plans under the Medicaid program for annual lung cancer screening with no cost sharing for individuals for whom screening is recommended by U.S. Preventive Services Task Force guidelines, to expand coverage under Medicaid of counseling and pharmacotherapy for cessation of tobacco use, and for other purposes; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Energy and Commerce; Ways and Means

H.R.4300 – To clarify the inability of the President to declare national emergencies under the National Emergencies Act, major disasters or emergencies under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and public health emergencies under the Public Health Service Act on the premise of climate change, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Transportation and Infrastructure; Energy and Commerce

H.R.4304 – To regulate human cadaveric islets for transplantation as organs; Sponsor: Rosendale Sr., Matthew M. [Rep.-R- MT-2]; Committees: House – Energy and Commerce

H.R.4306 – To amend title 38, United States Code, to establish presumptions of service connection for diseases associated with firefighting; Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House – Veterans’ Affairs

H.R.4307 – To authorize the President to enter into trade agreements for the reciprocal elimination of duties or other import restrictions with respect to medical goods to contribute to the national security and public health of the United States, and for other purposes; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means; Rules

After blocking floor votes on several bills in opposition to the spending caps set by the recent debt ceiling compromise negotiated by the White House and House Speaker Kevin McCarthy (R-Calif.), a small group of conservative Republicans in the House of Representatives appear to have won concessions from the Speaker to cut spending by an additional $120 billion. In defending his new agreement, McCarthy stated that the debt deal decided “a ceiling, not a floor” for spending, and that it was always his intention to pass appropriations legislation below the Fiscal Responsibility Act’s caps. The new plan would permit $1.47 trillion in discretionary spending for fiscal year (FY) 2024. The Departments of Labor, Education, and Health and Human Services would be cut by 29% under the GOP plan.

The House Appropriations Committee advanced its FY 2024 Agriculture-Rural Development-Food and Drug Administration (FDA) spending bill last week. The package, which was approved via a party-line vote, would trim 2.1% in overall spending compared to FY 2023. The bill provides $6.6 billion for the FDA, including user fee funding, less than the $7.2 billion requested by the agency in the President’s budget. It includes a provision to restrict access to the abortion medication mifepristone. The policy would nullify the FDA’s January decision to remove the in-person dispensing requirement for the drug. The legislation also includes a measure to prevent the agency from prohibiting the sale of menthol cigarettes and flavored cigars, or from limiting the amount of nicotine allowed in cigarettes. The Senate Appropriations Committee will begin consideration of the first of its FY 2024 spending bills this week, marking up the Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2024 and the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 on Thursday.

 

Lawmakers Grapple with Ongoing Drug Shortages

Democrats on the House Energy and Commerce Committee are threatening to oppose a package to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) if provisions to address the nation’s ongoing drug shortages are not included. The reauthorization package was negotiated by Energy and Commerce Committee members Richard Hudson (R-N.C.) and Anna Eshoo (D-Calif.), but Eshoo recently stated that she has pulled her support for the bill after Republicans refused to include a measure to increase transparency in the drug supply chain. During a legislative hearing focused on the PAHPA reauthorization last week, panel Republicans argued that a narrow reauthorization would help ensure House passage of the legislation, but committed to separately work on a bipartisan basis to address the problem of drug shortages. PAHPA’s pandemic preparedness programs expire September 30.

Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) are seeking information from health care stakeholders about the emerging and persistent drug shortages currently facing the nation. The lawmakers pose a series of 14 questions to inform their examination of the drivers of medication shortages and potential policy solutions “to bolster patient access and shore up our critical drug supply chains.” Feedback should be submitted to [email protected] by July 7.

 

Sanders Releases Report on Drug Pricing, Public Investment in Medical Research

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) has released a report highlighting the costs of drugs and medical devices that received funding from the National Institutes of Health (NIH). Sanders calls on the NIH to reinstate the use of reasonable pricing clauses in the agency’s contracting requirements. These clauses would force companies to set reasonable prices when they license NIH inventions. The HELP Committee has yet to notice a date for the confirmation hearing of Monica Bertagnolli to serve as the next NIH Director. Sanders has said that he will oppose any administration health nominee who does not commit to lowering drug prices.

 

Preventive Services Mandate Restored as Legal Challenge Proceeds

The Department of Justice (DOJ) has reached an agreement with the plaintiffs challenging the Affordable Care Act’s (ACA) preventive care mandate to protect no-cost coverage of certain services while the legal case proceeds. In exchange, DOJ has pledged to not enforce the mandate for the parties challenging the law who claim that coverage of HIV prevention drugs and other preventive care services violates their religious beliefs. The employers and individuals challenging the law have asserted that because members of the U.S. Preventive Services Task Force (USPSTF) are not Senate confirmed nor overseen by Senate confirmed federal employees, their recommendations for what services must be covered by insurers at no cost to the beneficiary cannot be enforced. They have also argued that coverage of pre-exposure prophylaxis medication – PrEP – to prevent the transmission of HIV violates their religious rights. The 5th U.S. Circuit Court of Appeals signed the stipulated order partially halting the lower court’s March ruling which struck the ACA’s requirement. While a ruling in the case is expected in the coming months, an appeal to the U.S. Supreme Court is likely no matter what decision the 5th Circuit reaches.

 

MedPAC, MACPAC Release June Reports to Congress

The Medicare Payment Advisory Commission (MedPAC) is recommending that the Centers for Medicare and Medicaid Services (CMS) lower its payment rates for telehealth services. MedPAC’s annual June Report to the Congress recommends that the agency rescind fee increases initially instituted in response to the COVID-19 pandemic as early as 2024. The Commission argues that providing care via telehealth does not cost practices as much as in-person care. The report suggests that the increased use of telehealth throughout the COVID-19 public health emergency did not adversely impact the quality of care, and only slightly increased costs for the Medicare program. MedPAC recommends that CMS work with Congress to standardize telehealth payments so as not to disincentivize in-person care, and expresses support for the use of beneficiary cost-sharing to help avoid overuse of virtual services.

The latest MedPAC report also recommends that lawmakers implement changes to the Medicare Part B benefit to lower drug spending. The panel suggests capping the payment rate for Part B drugs made available via the accelerated approval pathway, and recommends that Medicare be given the authority to use reference pricing to establish a single average sales price-based payment rate for Part B drugs and biologics with similar health effects. The report details the Commission’s concerns that current Medicare wage indexes are not accurate and create inequities in the health care system, and recommends that Congress replace current wage indexes with a new system for hospitals and providers. The June 2023 report also includes a recommendation that Congress align payment rates for the same services provided across different ambulatory settings.

The Medicaid and CHIP Payment and Access Commission (MACPAC) also released its June 2023 report last week. MACPAC recommends automatic adjustments to disproportion

 

New Research Paper Details MA Overpayments

Anew white paper from the Leonard D. Schaeffer Center for Health Policy & Economics indicates that Medicare Advantage (MA) plans were overpaid by 14.4% in 2020 due to favorable patient selection. Researchers found that patients with lower-than-average expenditures than those with similar risk factors were significantly more likely to switch from traditional Medicare to the MA program. As a result, the risk-score-adjusted expenditures for these 16.9 million beneficiaries who switched coverage between 2006 and 2019 were substantially below average. The report asserts that basing MA payment benchmarks on fee-for-service (FFS) expenditures is “increasingly problematic” as FFS enrollment continues to decline. Researchers stress the need for reforming how MA payments are set, such as by decoupling MA payments from FFS benchmarks or instituting competitive bidding.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health legislative hearing “Responding to America’s Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act;” 10:00 a.m.; June 21

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Competition and Transparency: the Pathway Forward for a Stronger Health Care Market;” 10:15 a.m.; June 21

 

House Veterans’ Affairs Subcommittee on Health hearing on H.R. 3520, Veterans Care Improvement Act; H.R. 1182, Veterans Serving Veterans Act; H.R. 1774, VA Emergency Transportation Act; H.R. 2683, VA Flood Preparedness Act; H.R. 2768, PFC Joseph P. Dwyer Peer Support Program Act; H.R. 2818, Autonomy for Disabled Veterans Act; H.R. 3581, Caregiver Outreach and Program Enhancement (COPE) Act; H.R. 1278, DRIVE Act; H.R. 1639, VA Zero Suicide Demonstration Project Act; and H.R. 1815, Expanding Veterans’ Options for Long Term Care Act; 10:30 a.m.; June 21

 

Senate Veterans’ Affairs Committee hearing “Examining the Effectiveness of the Office of Integrated Veteran Care;” 3:30 p.m.; June 21

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors;” 10:30 a.m.; June 22

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.Res.485 – Expressing support for the designation of “Batten Disease Awareness Day” on June 9. Sponsor: Bean, Aaron [Rep.-R-FL-4]; Committees: House – Oversight and Accountability

 

H.Res.490 – Supporting the designation of the week of June 12 through June 18, 2023, as “National Men’s Health Week”. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

 

H.R.3946 – To amend the Public Health Service Act to reauthorize and extend the Fetal Alcohol Spectrum Disorders Prevention and Services program, and for other purposes. Sponsor: Bacon, Don [Rep.-R-NE-2]; Committees: House – Energy and Commerce

 

H.R.3948 -To expand access to health care for veterans in the Freely Associated States, and for other purposes. Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Veterans’ Affairs

 

H.R.3962 – To establish a Federal Advisory Council to Support Victims of Gun Violence. Sponsor: Evans, Dwight [Rep.- D-PA-3]; Committees: House – Judiciary

 

H.R.3988 – To provide for congressional approval of national emergency declarations. Sponsor: Roy, Chip [Rep.-R- TX-21]; Committees: House – Transportation and Infrastructure; Foreign Affairs; Rules

 

H.R.3993 – To provide a private right of action against the maker of any component of a ghost gun, and any person who facilitated a sale of the ghost gun, for injury or death resulting from the use of the ghost gun. Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Judiciary

 

S.1922 – A bill to amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

S.1925 – A bill to require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.496 – Expressing support for the designation of June 13 as “Posttraumatic Growth Day”; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House – Energy and Commerce

 

H.Res.498 – Recognizing June 28, 2023, as the 125th anniversary of the American Association of Colleges of Osteopathic Medicine and commending its work to improve the health of the people of the United States; Sponsor: Graves, Sam [Rep.- R-MO-6]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4005 – To direct the Comptroller General of the United States to conduct a study on naloxone access; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce

 

H.R.4007 – To ensure references to opioid overdose reversal agents in grant programs of the Department of Health and Human Services are not limited to naloxone; Sponsor: Armstrong, Kelly [Rep.-R-ND-At Large]; Committees: House – Energy and Commerce

 

H.R.4009 – To establish emergency paid sick leave for individuals impacted by a public health emergency, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration; Judiciary; Ways and Means

 

H.R.4011 – To amend title XXVII of the Public Health Service Act to improve patient access to oral medications, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.4012 – To repeal the guidance titled “CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter”; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce

 

H.R.4027 – To amend title XVIII of the Social Security Act to eliminate late enrollment penalties under part B of the Medicare program for individuals residing in Puerto Rico if such individuals enroll within 5 years of becoming entitled to benefits under part A of such program; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4028 – To amend titles XVIII and XIX of the Social Security Act to make premium and cost-sharing subsidies available to low-income Medicare part D beneficiaries who reside in Puerto Rico or another territory of the United States; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4034 – To amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4047 – To amend title 38, United States Code, to increase the amount paid by the Secretary of Veterans Affairs to veterans for improvements and structural alterations furnished as part of home health services; Sponsor: Sorensen, Eric [Rep.-D-IL-17]; Committees: House – Veterans’ Affairs

 

S.Res.249 – A resolution expressing support for the designation of July 2023 as “National Sarcoma Awareness Month”; Sponsor: Johnson, Ron [Sen.-R-WI]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.250 – A resolution designating June 6, 2023, as National Naloxone Awareness Day; Sponsor: Scott, Rick [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.1950 – A bill to extend the temporary order for fentanyl-related substances; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.1951 – A bill to amend title 38, United States Code, to expand entitlement of veterans to care from the Department of Veterans Affairs and to guarantee health care benefits for veterans enrolled in the patient enrollment system of the Department, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Veterans’ Affairs

 

S.1954 – A bill to improve the provision of health care furnished by the Department of Veterans Affairs for veterans diagnosed with diabetes and heart disease, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Veterans’ Affairs

 

S.1961 – A bill to require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4053 – To provide for the review of the scheduling under the Controlled Substances Act of buprenorphine-naloxone combination products, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4054 – To amend the SUPPORT for Patients and Communities Act to reauthorize grants to improve trauma support services and mental health care for children and youth in educational settings; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House – Education and the Workforce

 

H.R.4056 – To amend title XIX of the Social Security Act to ensure that medical assistance is available to children in foster care who are placed in a qualified residential treatment program under the Medicaid program; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.4057 – To amend the SUPPORT for Patients and Communities Act to reauthorize surveillance and data collection by the Centers for Disease Control and Prevention for child, youth, and adult trauma; Sponsor: Blunt Rochester, Lisa [Rep.-D- DE-At Large]; Committees: House – Energy and Commerce

 

H.R.4061 – To require the Secretary of Health and Human Services to establish an exposure registry and conduct epidemiological studies to assess health outcomes associated with the Red Hill Incident; Sponsor: Case, Ed [Rep.-D-HI-1]; Committees: House – Energy and Commerce; Armed Services

 

H.R.4063 – To amend the SUPPORT for Patients and Communities Act to reauthorize a pilot program for public health laboratories to detect fentanyl and other synthetic opioids; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.4076 – To authorize funding for a bilateral cooperative program with Israel for the development of health technologies; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce

 

H.R.4079 – To amend the Public Health Service Act to reauthorize a loan repayment program for the substance use disorder treatment workforce; Sponsor: Rogers, Harold [Rep.-R-KY-5]; Committees: House – Energy and Commerce

 

H.R.4080 – To amend the SUPPORT for Patients and Communities Act to extend a task force to develop best practices for trauma-informed identification, referral, and support; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Education and the Workforce; Energy and Commerce; Judiciary

 

H.R.4087 – To prohibit the use of Federal funds to conduct or support certain gain-of-function research by a foreign adversary; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce

 

S.1967 – A bill to amend title XVIII of the Social Security Act to establish requirements relating to the responsibility of pharmacy benefit managers under Medicare part D; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1976 – A bill to amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.1991 – A bill to reauthorize certain programs under the SUPPORT for Patients and Communities Act, and for other purposes; Sponsor: McConnell, Mitch [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1994 – A bill to amend title 38, United States Code, to require medical facilities of the Department of Veterans Affairs to share certain data with State cancer registries, and for other purposes; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Veterans’ Affairs

 

S.1995 – A bill to support public health infrastructure; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1999 – A bill to protect an individual’s ability to access contraceptives and to engage in contraception and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4088 – To amend the SUPPORT for Patients and Communities Act to reauthorize a program to support individuals in substance use disorder treatment and recovery to live independently and participate in the workforce, and for other purposes; Sponsor: Barr, Andy [Rep.-R-KY-6]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4089 – To amend the Public Health Service Act to reauthorize grants for first responder training; Sponsor: D’Esposito, Anthony [Rep.-R-NY-4]; Committees: House – Energy and Commerce

 

H.R.4091 – To amend the SUPPORT for Patients and Communities Act to expand required reports on T-MSIS substance use disorder data to include mental health condition data; Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House – Energy and Commerce

 

H.R.4092 – To amend the Public Health Service Act to reauthorize support for residential treatment programs for pregnant and postpartum women; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce

 

H.R.4093 – To provide for a study on the effects of remote monitoring on individuals who are prescribed opioids; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce

 

H.R.4095 – To amend the Public Health Service Act to reauthorize grants to address the problems of persons who experience violence related stress; Sponsor: De La Cruz, Monica [Rep.-R-TX-15]; Committees: House – Energy and Commerce

 

H.R.4096 – To amend title XIX of the Social Security Act to expand the application of Medicaid State programs to monitor antipsychotic medications to all Medicaid beneficiaries; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.4097 – To amend the Public Health Service Act to reauthorize mental and behavioral health education and training grants; Sponsor: Sykes, Emilia Strong [Rep.-D-OH-13]; Committees: House – Energy and Commerce

 

H.R.4098 – To amend the Public Health Service Act to reauthorize grants for building communities of recovery; Sponsor: Pettersen, Brittany [Rep.-D-CO-7]; Committees: House – Energy and Commerce

 

H.R.4099 – To amend the Public Health Service Act to reauthorize a program of preventing overdoses of controlled substances; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4100 – To amend the Public Health Service Act to reauthorize a monitoring and education program regarding infections associated with illicit drug use and other risk factors; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Energy and Commerce

 

H.R.4101 – To amend the Public Health Service Act to reauthorize a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support; Sponsor: James, John [Rep.-R-MI-10]; Committees: House – Energy and Commerce

 

H.R.4102 – To amend the SUPPORT for Patients and Communities Act to reauthorize the Recovery Housing Program; Sponsor: Barr, Andy [Rep.-R-KY-6]; Committees: House – Financial Services

 

H.R.4104 – To amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4105 – To amend the Controlled Substances Act to prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances, and for other purposes; Sponsor: Buck, Ken [Rep.-R-CO-4]; Committees: House – Judiciary; Energy and Commerce

 

H.R.4106 – To amend the 21st Century Cures Act to expressly authorize the use of certain grants to implement substance use disorder and overdose prevention activities with respect to fentanyl and xylazine test strips; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

 

H.R.4110 – To provide the Food and Drug Administration with authority to conduct microbial sampling on concentrated animal feeding operations as necessary to facilitate a foodborne illness outbreak investigation, determine the root cause of an outbreak of foodborne illness, or address other public health needs; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

 

H.R.4115 – To amend title XVIII of the Social Security Act to apply prescription drug inflation rebates to drugs furnished in the commercial market and to change the base year for rebate calculations; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4121 – To protect an individual’s ability to access contraceptives and to engage in contraception and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Energy and Commerce

 

H.R.4122 – To award posthumously a Congressional Gold Medal to Henrietta Lacks, in recognition of her immortal cells which have made invaluable contributions to global health, scientific research, our quality of life, and patients’ rights; Sponsor: Mfume, Kweisi [Rep.-D-MD-7]; Committees: House – Financial Services; House Administration

 

Recently Introduced Health Legislation Contd.

H.R.4132 – To provide for the imposition of sanctions with respect to forced organ harvesting within the People’s Republic of China, and for other purposes; Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Foreign Affairs; Judiciary

 

H.R.4134 – To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce

 

S.Res.255 – A resolution expressing support for the designation of June 19, 2023, as “World Sickle Cell Awareness Day” in order to increase public awareness across the United States and global community about sickle cell disease and the continued need for empirical research, early detection screenings, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions relating to sickle cell disease; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Foreign Relations

 

S.Res.257 – A resolution designating July 19, 2023, as “Glioblastoma Awareness Day”; Sponsor: Graham, Lindsey [Sen.-R- SC]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2009 – A bill to amend the Older Americans Act of 1965 to authorize a national network of statewide senior legal hotlines, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2012 – A bill to amend title XVIII of the Social Security Act to provide for coverage of dental services under the Medicare program; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

 

S.2016 – A bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate – Finance

 

S.2024 – A bill to provide for the establishment of an education program to expand abortion care training and access; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2026 – A bill to provide support for programs of the Department of Veterans Affairs relating to the coordination of maternity health care, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Veterans’ Affairs

 

S.2039 – A bill to amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.514 – Expressing support for the designation of June 19, 2023, as “World Sickle Cell Awareness Day” in order to increase public alertness across the United States and global community about sickle cell disease, the continued need for empirical research, early detection screenings for sickle cell trait carriers, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions related to sickle cell disease; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Energy and Commerce

 

H.R.4146 – To amend title XVIII of the Social Security Act to provide for coverage of dental services under the Medicare program; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4147 – To provide for the establishment of an education program to expand abortion care training and access; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce

 

H.R.4150 – To improve the provision of health care furnished by the Department of Veterans Affairs for veterans diagnosed with diabetes and heart disease, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.4157 – To require the Secretary of Veterans Affairs to prepare an annual report on suicide prevention, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Veterans’ Affairs

 

H.R.4182 – To improve men’s health initiatives, and for other purposes; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce

 

H.R.4189 – To amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Energy and Commerce; Ways and Means

Congress passed legislation last week to suspend the debt ceiling until 2025. Passage of the Fiscal Responsibility Act (H.R. 3746) ends the most significant standoff over the nation’s borrowing limit since 2011. The debt ceiling deal was passed by the House of Representatives on Wednesday 314-117 with support from 149 Republicans, including eight hard right Freedom Caucus members, and 165 Democrats. The Senate approved the measure on Thursday in a 63-36 vote with support from 44 Democrats, 2 Independents, and only 17 Republicans. President Joe Biden signed the bill into law on June 3, two days before the government would have defaulted on its debt obligations in the absence of a borrowing cap extension. The Congressional Budget Office (CBO) estimates that the agreement will reduce the deficit by $1.5 trillion through fiscal year (FY) 2033, including a $1.3 trillion reduction in discretionary spending starting in FY 2024. The agreement includes a 1% sequester on discretionary spending which would be triggered should Congress fail to pass all FY 2024 appropriations bills. The cuts would not impact mandatory programs such as Medicare and Social Security. The compromise was the culmination of weeks of negotiations between the White House and the office of House Speaker Kevin McCarthy (R-Calif.). While it was passed with bipartisan support in both chambers of Congress, the bill was criticized by the flanks of each party for the concessions made by both Republican and Democratic leadership. The table beginning on page two summarizes the major spending and policy provisions contained in the deal.

Durbin Urges FDA to Address Cancer Drug Shortages

Senate Judiciary Committee Chair Dick Durbin (D-Ill.) sent a letter to the Food and Drug Administration (FDA) last week calling on the agency to address ongoing shortages of the critical cancer medications carboplatin and cisplatin. In the letter, Durbin describes the adverse impact of drug shortages on medical research and ongoing clinical trials and discusses the widespread problems with the nation’s drug and medical supply chain. In the short term, he recommends that FDA “use its authority to allow for the safe importation of these drugs from other countries, work with manufacturers to extend expiration dates-if safe and appropriate-on existing supplies of the drugs, regularly provide clear and timely updates to providers on expected timelines for additional supply, and ensure expedited inspections and reviews to assist in resolving this shortage.”

Utah Representative Chris Stewart Announces Resignation

Utah Representative Chris Stewart (R-Utah) has announced his resignation from Congress citing his wife’s current health concerns. Stewart has served the second district of Utah for a decade. Before being elected to Congress in 2012, he was the CEO of the Shipley Group, a consulting firm focusing on energy and the environment. Stewart sits on the House Permanent Select Committee on Intelligence and the Appropriations Committee. He is also a member of the Judiciary Committee’s Select Subcommittee on the Weaponization of the Federal Government. Stewart has said that he will step down as soon as there is an orderly transition process in place. His resignation will have a negligible impact on the chamber’s balance of power given Rep. David Cicilline’s (D-R.I.) departure on June 1st. Cicilline previously announced plans to leave Congress to lead the Rhode Island Foundation. Congressman Cicilline served the first district of Rhode Island for 12 years. Prior to being elected to Congress, he was the mayor of Providence for two terms. Cicilline was a member of the Judiciary Committee and the Foreign Affairs Committee.

Biden Expected to Appoint Mandy Cohen to Lead CDC

President Joe Biden is expected to tap former North Carolina health secretary Mandy Cohen to replace the outgoing Rochelle Walensky as the next director of the Centers for Disease Control and Prevention (CDC). Walensky plans to step down from her post at the end of this month. Cohen is an internal medicine physician who served as chief of staff and later chief operations officer at the Centers for Medicare and Medicaid Services during the Obama administration. As North Carolina Department of Health and Human Services Secretary from 2017 to 2021, Cohen led the state’s response to the COVID-19 pandemic. She currently works as an executive at Aledade, a private sector firm that works to support physician-led accountable care organizations and value-based care solutions. According to the Washington Post, the President will make a formal announcement of his pick later this month. The position of CDC director does not currently require Senate confirmation.

96% of Americans Have Some Level of COVID-19 Immunity

New data from the Centers for Disease Control and Prevention (CDC) indicates that 96% of Americans have some level of COVID-19 antibodies present in their bodies. The CDC analyzed data from blood samples of approximately 143,000 Americans ages 16 and older from July through September 2022 and found that 96% of them contained antibodies to SARS-CoV-2 from previous infection or vaccination. This figure includes 22.6% from infection alone and 26.1% from vaccination alone; 47.7% had hybrid immunity. Hybrid immunity prevalence was lowest among adults aged 65 years or older. In CDC’s last analysis between April and June 2021, only 68% of blood samples contained COVID-19 antibodies.

Upcoming Congressional Hearings and Markups

House Education and Workforce Committee markup to consider five bills, including H.R. 1147, Whole Milk for Healthy Kids Act of 2023, H.R. 2813, Self-Insurance Protection Act, H.R. 2868, Association Health Plans Act, and H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; 10:15 a.m.; June 6

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Looking Back Before Moving Forward: Assessing CDC’s Failures in Fulfilling its Mission;” 10:30 am.; June 7

Senate Judiciary Subcommittee on Intellectual Property hearing “Artificial Intelligence and Intellectual Property – Part I: Patents, Innovation, and Competition;” 3:00 p.m.; June 7

Senate Veterans’ Affairs Committee hearing “An Abiding Commitment to Those Who Served: Examining Veterans’ Access to Long Term Care;” 3:00 p.m.; June 7

Senate Finance Committee hearing “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs;” 10:00 a.m.; June 8

Senate Health, Education, Labor, and Pensions Committee hearing “Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions” 10:00 a.m.; June 8

Senate Judiciary Committee Executive Session to consider S. 1080, Cooper Davis Act to amend the Controlled Substances Act to require electronic communication service providers and remote computing services to report to the Attorney General certain controlled substances violations; 10:00 a.m.; June 8

House Energy and Commerce Subcommittee on Health field hearing “Addressing the Opioid Crisis: Examining the SUPPORT Act Five Years Later;” 9:30 a.m.; June 9

POLICY BRIEFINGS
Recently Introduced Health Legislation

H.R.3742 – To direct the Comptroller General of the United States to evaluate the Federal Government’s collection and sharing of public health data to respond to public health emergencies. Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Energy and Commerce

H.R.3741 – To amend title X of the Public Health Service Act to prohibit funds under such title from being used for any system through which counseling or referrals are provided to individuals regarding abortion services. Sponsor: Mann, Tracey [Rep.-R-KS-1]; Committees: House – Energy and Commerce

S.1755 – A bill to amend title 10, United States Code, to extend the period during which certain survivors of a member of the Selected Reserve of the Ready Reserve of a reserve component of the Armed Forces are eligible for health benefits under TRICARE Reserve Select; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Armed Services

H.R.3751 – To require the Secretary of Defense to submit a report on overdoses among members of the Armed Forces; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Armed Services H.R.3752 – To provide for civil monetary penalties for violations of mental health parity requirements; Sponsor: Norcross, Donald [Rep.-D-NJ-1]; Committees: House – Education and the Workforce

S.Res.229 – A resolution designating May 2023 as “National Brain Tumor Awareness Month”; Sponsor: Daines, Steve [Sen.-R-MT]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.1766 – A bill to require the Secretary of Defense to submit a report on overdoses among members of the Armed Forces; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Armed Services

S.1767 – A bill to amend the Public Health Service Act to provide for emergency grants to safeguard essential health care workers, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.1769 – A bill to amend title XIX of the Social Security Act to establish a demonstration project testing Whole Child Health Models, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

S.1773 – A bill to amend the Public Health Service Act to provide for a national outreach and education strategy and research to improve behavioral health among the Asian American, Native Hawaiian, and Pacific Islander population, while addressing stigma against behavioral health treatment among such population; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

S.1774 – A bill to amend the Social Security Act to provide for an increased Federal medical assistance percentage for State expenditures on certain behavioral health services furnished under the Medicaid program, and for other purposes; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate – Finance

S.1784 – A bill to increase language access to behavioral health services at eligible health centers, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

S.1785 – A bill to establish programs to address addiction and overdoses caused by illicit fentanyl and other opioids, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.459 – Expressing support for the designation of June 2, 2023, as “National Gun Violence Awareness Day” and June 2023 as “National Gun Violence Awareness Month”; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Judiciary

H.Res.460 – Expressing the sense of the House of Representatives that the Congress should enact the Older Americans Bill of Rights to establish that older Americans should have the right to live with dignity and with independence; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

H.R.3759 – To direct the Secretary of Transportation to establish a grant program to facilitate the installation, on bridges, of evidence-based suicide deterrents, including suicide prevention nets and barriers, and for other purposes; Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Transportation and Infrastructure

H.R.3760 – To amend title VII of the Public Health Service Act to strengthen the mental health workforce, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Energy and Commerce

H.R.3761 – To amend the Social Security Act to provide for an increased Federal medical assistance percentage for State expenditures on certain behavioral health services furnished under the Medicaid program, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.3768 -To address maternity care shortages and promote optimal maternity outcomes by expanding educational opportunities for midwives, and for other purposes; Sponsor: Hinson, Ashley [Rep.-R-IA-2]; Committees: House – Energy and Commerce

H.R.3771 – To establish a multiagency Middle School Mental Health Task Force at the Department of Education and the Department of Health and Human Services; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House – Education and the Workforce; Energy and Commerce

S.Res.231 – A resolution expressing support for the designation of June 2, 2023, as “National Gun Violence Awareness Day” and June 2023 as “National Gun Violence Awareness Month”; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Judiciary

S.Res.232 – A resolution expressing support for the designation of May 17, 2023, as “DIPG Pediatric Brain Cancer Awareness Day” to raise awareness of, and encourage research on, diffuse intrinsic pontine glioma tumors and pediatric cancers in general; Sponsor: Rubio, Marco [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.234 – A resolution designating May 2023 as “Older Americans Month”; Sponsor: Kelly, Mark [Sen.-D-AZ]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.235 – A resolution supporting the designation of the week of May 7, 2023, as “Children’s Mental Health Awareness Week” and May 11, 2023, as “Children’s Mental Health Awareness Day”; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.1792 – A bill to amend title 38, United States Code, to modify the program of comprehensive assistance for family caregivers of veterans, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

S.1797 – A bill to establish a demonstration program to allow States to test payment models for maternity care provided under Medicaid and the Children’s Health Insurance Program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

S.1798 – A bill to establish a Countering Weapons of Mass Destruction Office and an Office of Health Security in the Department of Homeland Security, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

S.1800 – A bill to amend the Public Health Service Act to reauthorize and extend the Fetal Alcohol Spectrum Disorders Prevention and Services program, and for other purposes; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Health, Education, Labor, and Pensions

S.1803 – A bill to amend title XVIII of the Social Security Act to revise payment for air ambulance services under the Medicare program; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

H.R.3783 – To protect public health and human safety by prohibiting the farming of mink for their fur, to compensate farmers as they transition out of the industry, and for other purposes; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Agriculture; Budget

H.R.3791 – To amend the Public Health Service Act with respect to public health data accessibility, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

President Joe Biden and House Speaker Kevin McCarthy (R-Calif.) have reached a deal to avert a U.S. default on its debt obligations and suspend the debt ceiling through January 2025. The agreement – dubbed the Fiscal Responsibility Act – caps non-defense spending, keeping it roughly flat in 2024 and increasing it by just 1% in 2025. It includes a penalty if Congress fails to pass fiscal year (FY) 2024 appropriations legislation, imposing a 1% across the board cut if the bills are not passed. The compromise also expands work requirements in the Supplemental Nutrition Assistance Program from up to age 49 under current law to age 54. The more stringent work requirements would sunset in 2030 without further action by Congress.

The deal was crafted by Office of Management and Budget Director Shalanda Young, White House senior adviser Steve Ricchetti, White House legislative affairs director Louisa Terrell, Rep. Garret Graves (R-La.), Rep. Patrick McHenry (R-N.C.), and the Speaker’s chief of staff Dan Meyer. The House of Representatives will return to session during a planned Memorial Day recess. The House Rules Committee will consider the bill on Tuesday afternoon and McCarthy is expected to bring the bill for a vote on the House floor on Wednesday. Both Republican and Democratic leadership have indicated that there is enough support to pass the deal. If the package is sent to the Senate on Wednesday, the chamber could then vote on the bill as early as Saturday morning (June 3), unless members agree to advance the measure via unanimous consent. The Treasury is projected to run out of cash reserves on June 5.

In related news, the House Appropriations Committee postponed the markup of four FY 2024 appropriations bills last week, citing the then ongoing debate on the debt limit. Chair Kay Granger (R-Texas) stated that she wished to give Speaker McCarthy “maximum flexibility” as he engaged in debt ceiling negotiations with the White House. The panel was scheduled to mark up the Agriculture-Rural Development-Food and Drug Administration spending package last Wednesday. The Senate Appropriations Committee previously announced plans to consider funding bills starting in June.

 

House Passes WH-Endorsed Fentanyl Bill

The House of Representatives passed the HALT Fentanyl Act (H.R. 467) last week. The bill would make permanent the temporary scheduling of fentanyl-related substances (FRS) as Schedule I substances, which are subject to heighted regulatory and law enforcement. The temporary scheduling of FRS is set to expire at the end of 2024. The bill would cover those substances with a high potential for abuse and no currently accepted medical use; medical-grade fentanyl would continue to be a Schedule II substance. Seventy-four Democrats joined Republicans in support of the measure, which was also endorsed by the White House. Other Democrats, however, including House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), criticized the legislation and raised concerns about its potential to exacerbate inequities in the criminal justice system and the possible implications for FRS that are found that have medical applications.

 

E&C Advances Six Health Bills

The House Energy and Commerce Committee advanced nineteen bills last week, including legislation to overhaul the nation’s organ donation system and to reform pharmacy benefit manager (PBM) practices. The panel advanced the six following health bills out of committee:

• H.R. 1418, theAnimal Drug User Fee Amendments of 2023was favorably reported to the House by a bipartisan vote of 49-0.
• H.R. 2544, theSecuring the U.S. Organ Procurement and Transplantation Network Actwas favorably reported to the House by a bipartisan vote of 48-0.
• H.R. 2666, theMedicaid VBPs for Patients (MVP) Actwas reported favorably to the House by a bipartisan vote of 31- 19.
• H.R. 3284, theProviders and Payers COMPETE Actwas reported favorably to the House by a bipartisan vote of 49-0.
• H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, was favorably reported to the House by a vote of 29-22.
• H.R. 3561, thePromoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023or the PATIENT Act of 2023 was favorably reported to the House by a bipartisan vote of 49-0. The bill was amended to includeH.R. 3285, theFairness for Patient Medications Act.

 

Select COVID-19 Subcommittee Probes NIH Funding to Chinese Lab

House Select Subcommittee on the Coronavirus Crisis Pandemic Chairman Brad Wenstrup (R-Ohio) has sent a letter to the National Institutes of Health (NIH) requesting information on its 2020 decision to cut funding for the Wuhan Institute of Virology (WIV). According to a letter obtained by the panel, the NIH informed the University of California, Irvine in May 2020 that it would be terminating the subgrant funding to the Chinese laboratory because its research posed “serious bio-safety concerns.” Wenstrup blames the agency for publicly obscuring its support for the work of the WIV, which some suspect is the origin of the COVID-19 pandemic, while privately acknowledging the safety concerns posed by the research.

 

CBO Releases Latest Health Coverage Projections

The Congressional Budget Office (CBO) released updated projections last week of health insurance coverage for people under age 65 over the next decade. The share of Americans under age 65 who are uninsured is currently at a historic low of 8.3%, which CBO attributes to temporary policies instituted in response to the COVID-19 pandemic, including continuous coverage provisions in state Medicaid programs and enhanced premium subsidies in theAffordable Care Act’sindividual marketplace. CBO’s analysis indicates that more than six million people will lose their health insurance coverage following the end of these COVID-era policies. While the nation’s uninsured rate will remain below pre-pandemic levels, it is expected to rise from 8.3% to 10.1% in 2033.

 

Longtime Delaware Senator Carper to Retire in 2024

Sen. Tom Carper (D-Del.), 76, announced last week that he will not run for reelection in 2024. Carper has served for over 20 years in the Senate. Prior to this time, he served as the governor of Delaware and as the state’s sole representative in the U.S. House for five terms. He currently sits on the Enviornment and Public Works, Finance, and Homeland Security and Governmental Affairs committees. He is the fourth Democratic senator – along with Dianne Feinstein (Calif.), Debbie Stabenow (Mich.), and Ben Cardin (Md.) – to announce his retirement from the chamber. Carper has endorsed Rep. Lisa Blunt Rochester (D-Del.) to succeed him. Blunt Rochester has indicated that she is interested in running for the seat but has not officially announced her candidacy.

 

CMS Releases Updated FAQ on PHE Unwinding

The Centers for Medicare and Medicaid Services (CMS) released an updated frequently asked questions document last week on the end of the COVID-19 public health emergency (PHE) indicating that the Medicare program will no longer cover telehealth services provided by hospital-based physical and occupational therapists and speech language pathologists beyond 2023. CMS states that it will exercise discretion through the end of this year to continue paying for outpatient therapy provided via telehealth billed from institutional providers. The agency did not specify for how long skilled nursing facilities and home health agencies could continue to bill for telehealth therapy services. The most recent omnibus spending bill delinked Medicare telehealth access from the PHE declaration, extending reimbursement for certain telehealth services through 2024.

 

Upcoming Congressional Hearings and Markups

House Rules Committee meeting to consider the Fiscal Responsibility Act of 2023; 3:00 p.m.; May 30

 

Senate Judiciary Committee Executive Session to consider S. 1080,Cooper Davis Actto amend the Controlled Substances Act to require electronic communication service providers and remote computing services to report to the Attorney General certain controlled substances violations, and S. 474,REPORT Act;10:00 a.m.; June 1

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

 

H.Res.434 – Declaring a mental health crisis among youth in the United States, and expressing the pressing need for historic investments in mental health care for students; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.436 – Expressing support for the designation of the week of May 22 through 26, 2023, as “Educator Mental Health Awareness Week”; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Education and the Workforce

 

H.R.3561 -To promote hospital and insurer price transparency, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.3570 – To provide public awareness and outreach regarding the dangers of fentanyl, to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program, to expand treatment and recovery services for people with opioid addictions, and to increase and to provide enhanced penalties for certain offenses involving counterfeit pills; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

 

H.R.3577 – To require the Assistant Secretary for Preparedness and Response to establish an automated supply chain tracking application that provides near real-time insight into the amount of critical medical and health supplies available in the Strategic National Stockpile; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.3581 – To amend title 38, United States Code, to modify the family caregiver program of the Department of Veterans Affairs to include services related to mental health and neurological disorders, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Veterans’ Affairs

 

H.R.3583 – To provide for the overall health and well-being of young people, including the promotion and attainment of lifelong sexual health and healthy relationships, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.3584 – To direct the Secretary of Veterans Affairs to conduct and support research on the efficacy and safety of medicinal cannabis, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Veterans’ Affairs

 

H.R.3589 – To require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.Con.Res.48 – Condemning the Chinese Communist Party for the Wuhan Lab “leak” causing the deadly COVID-19 pandemic; Sponsor: Santos, George [Rep.-R-NY-3]; Committees: House – Foreign Affairs

 

H.R.3613 – To amend title XXVIII of the Public Health Service Act to eliminate the sunset of authority to make certain appointments for National Disaster Medical System, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce

 

H.R.3616 – To direct the Administrator of the Federal Aviation Administration to include medications and medical equipment for the emergency treatment of known or suspected opioid overdose in aircraft emergency medical kits, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Transportation and Infrastructure

 

H.R.3617 – To amend title 10, United States Code, to expand the authority to provide a wig and treat traction alopecia under the TRICARE program, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Armed Services

 

H.R.3619 – To amend the Federal Food, Drug, and Cosmetic Act to ban certain substances in cosmetic products, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3620 – To amend the Public Health Service Act with respect to cosmetic safety, with an emphasis on communities of color and professional salon workers, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.3621 – To amend title VI of the Federal Food, Drug, and Cosmetic Act to provide for greater transparency with respect to fragrance and flavor ingredients in cosmetics, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D- IL-9]; Committees: House – Energy and Commerce

 

H.R.3622 – To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cosmetics, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3623 – To amend title XVIII of the Social Security Act to establish a national graduate nurse education program; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3629 – To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Judiciary

 

H.R.3631 – To amend the Public Health Service Act to extend the authorization of appropriations for grants for State strategic stockpiles; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.3633 – To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.3635 – To amend title XVIII of the Social Security Act to ensure fairness in Medicare hospital payments by establishing a floor for the area wage index applied with respect to certain hospitals; Sponsor: Ferguson, A. Drew, IV [Rep.- R-GA-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3641 – To direct the Secretary of Veterans Affairs to rescind guidelines and ensure the removal of signs and guidance relating to the COVID-19 pandemic; Sponsor: Jackson, Ronny [Rep.-R-TX-13]; Committees: House – Veterans’ Affairs

 

H.R.3644 – To amend title 38, United States Code, to extend the authorization period for emergency treatment in non- Department of Veterans Affairs medical facilities under the Veterans Community Care Program; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Veterans’ Affairs

 

H.R.3645 – To amend the Public Health Service Act to establish emergency grants to safeguard essential health care workers, and for other purposes; Sponsor: Lee, Summer L. [Rep.-D-PA-12]; Committees: House – Energy and Commerce

 

H.R.3649 – To direct the Secretary of Veterans Affairs to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Veterans’ Affairs

 

H.R.3659 – To amend the Public Health Service Act to provide for a demonstration program to facilitate the clinical adoption of pregnancy intention screening initiatives by health care and social service providers; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce

 

H.R.3664 – To prohibit the availability of Federal funds to the World Health Organization pending the conduct of an investigation relating to the influence over such organization by Chinese Communist Party, and for other purposes; Sponsor: Santos, George [Rep.-R-NY-3]; Committees: House – Foreign Affairs

 

H.R.3668 – To amend title 10, United States Code, to improve the TRICARE program for certain members of the Retired Reserve of the reserve components; Sponsor: Johnson, Bill [Rep.-R-OH-6]; Committees: House – Armed Services

 

H.R.3669 – To amend the Elementary and Secondary Education Act of 1965 to improve mental health services for students, and for other purposes; Sponsor: Allen, Rick W. [Rep.-R-GA-12]; Committees: House – Education and the Workforce

 

H.R.3671 – To require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Science, Space, and Technology

 

H.R.3674 – To amend title XVIII of the Social Security Act to increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3677 – To direct the Comptroller General of the United States to conduct reviews of certain budget requests of the President for the medical care accounts of the Department of Veterans Affairs; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.3679 – To direct the Administrator of the Federal Aviation administration to develop an interagency task force to develop and implement a strategy to identify and advance research on communicable diseases in air travel, and for other purposes; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Science, Space, and Technology

 

H.R.3680 – To amend the Public Health Service Act to provide for a national outreach and education strategy and research to improve the behavioral and mental health of the Asian American, Native Hawaiian, and Pacific Islander population, while addressing stigma within such population against behavioral and mental health treatment; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce

 

H.R.3682 – To amend the Public Health Service Act to authorize certain grants (for youth suicide early intervention and prevention strategies) to be used for school personnel in elementary and secondary schools and students in secondary schools to receive student suicide awareness and prevention training, and for other purposes; Sponsor: Cleaver, Emanuel [Rep.-D-MO-5]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.3684 – To direct the Secretary of Defense to establish a grant program for using psychedelic substances to treat certain conditions, and for other purposes; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Armed Services

 

H.R.3688 – To provide for the mandatory recall of drugs regulated by the Food and Drug Administration; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

 

H.R.3691 – To amend title XVIII of the Social Security Act to revise payment for air ambulance services under the Medicare program; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3701 – To amend title XIX of the Social Security Act to strengthen coverage under the Medicaid program for certain foster youth individuals; Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Energy and Commerce

 

H.R.3703 – To direct the Comptroller General of the United States to conduct and complete a review examining the efforts of the Secretary of Health and Human Services to ensure that the United States is prepared to rapidly produce certain medical countermeasures in the event of a public health emergency, and for other purposes; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Energy and Commerce

 

H.R.3706 – To expand and enhance existing adult day programs for younger people with neurological diseases or conditions (such as multiple sclerosis, Parkinson’s disease, traumatic brain injury, or other similar diseases or conditions) to support and improve access to respite services for family caregivers who are taking care of such people, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce

 

H.R.3707 – To amend the Internal Revenue Code of 1986 to provide a tax credit for expenses for household and elder care services necessary for gainful employment; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Ways and Means

 

H.R.3710 – To amend title 18, United States Code, to prohibit health professionals from providing false or misleading information with respect to assisted reproduction, and for other purposes; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Judiciary

 

H.R.3713 – To amend the Public Health Service Act to revise and extend projects relating to children and to provide access to school-based comprehensive mental health programs; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.3718 – To require the Secretary of Veterans Affairs to take certain actions to improve the processing by the Department of Veterans Affairs of claims for disability compensation for post-traumatic stress disorder, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Veterans’ Affairs

 

H.R.3722 – To require a pilot program on activities under the pre-separation transition process of members of the Armed Forces for a reduction in suicide among veterans, and for other purposes; Sponsor: Nunn, Zachary [Rep.-R-IA-3]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.3723 – To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means; Sponsor: Obernolte, Jay [Rep.-R-CA-23]; Committees: House – Energy and Commerce

 

H.R.3725 – To amend title XVIII of the Social Security Act to provide benefits under the Medicare program for first responders at the age of 57; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3726 – To direct the Secretary of Education to study student mental health at institutions of higher education and to issue guidance on compliance with the Americans with Disabilities Act of 1990 for mental health and substance use disorder policies of institutions of higher education, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Education and the Workforce

 

H.R.3730 – To amend title XVIII of the Social Security Act to modernize provisions relating to rural health clinics under Medicare; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3731 – To authorize the Secretary of Health and Human Services to award grants to reduce barriers to immigrants becoming nurses or allied health professionals in the United States, and for other purposes; Sponsor: Smith, Adam [Rep.- D-WA-9]; Committees: House – Energy and Commerce

 

H.R.3732 – To authorize the Secretary of Health and Human Services to award grants for career support for skilled internationally educated health professionals; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce

 

H.R.3733 – To address barriers immigrants and refugees face to entering the health care workforce, and for other purposes; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3736 – To amend title XIX of the Social Security Act to extend the requirement for State Medicaid plans to provide coverage for medication-assisted treatment; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3737 – To direct the Director of the Centers for Disease Control and Prevention to submit a report to Congress on the feasibility of reporting data relating to injuries in high school sports to improve the safety of student athletes; Sponsor: Veasey, Marc A. [Rep.-D-TX-33]; Committees: House – Energy and Commerce; Education and the Workforce

The House Appropriations Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration (FDA) advanced its fiscal year 2024 spending bill by voice vote last week. The bill would provide $6.6 billion in funding for the FDA, less than the $7.2 billion requested in the President’s budget. It includes provisions to block the FDA from allowing mail-order access to mifepristone and from banning menthol or setting a maximum nicotine level in cigarettes. The measure was criticized by panel Democrats who indicated plans to offer numerous amendments during the full committee markup, which is scheduled for May 24.

 

E&C Health Subcommittee Advances 17 Health Bills

The House Energy and Commerce Subcommittee on Health advanced 17billslast week, including legislation to overhaul the nation’s organ donation system, mandate additional reporting in the 340B program, reform pharmacy benefit manager (PBM) practices, and permit value-based purchasing agreements in state Medicaid programs. The panel advanced the following bills to the full committee:

• • H.R. 3281, theTransparent PRICE Actwhich was amended to include the following bills:
    • H.R. 3237, to require each outpatient department of a provider to include a unique identification number on claims for services, and to require hospitals with an outpatient department of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each outpatient department
    • H.R. 3262, to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information
    • H.R. 3248, theDiagnostic Lab Testing Transparency Act
    • H.R. 3282, thePromoting Transparency and Healthy Competition in Medicare Act
    • H.R. 2679, thePBM Accountability Act
    • H.R. 2559, theStrengthening Community Care Act of 2023
    • H.R. 2550, theSpecial Diabetes Program Reauthorization Act of 2023
    • H.R. 2547, theSpecial Diabetes Program for Indians Reauthorization Act of 2023
    • H.R. 2665, theSupporting Safety Net Hospitals Act
    • H.R. 1613, theDrug Price Transparency in Medicaid Act of 2023
  • H.R. 1418, theAnimal Drug User Fee Amendments of 2023
  • H.R. 2544, theSecuring the U.S. Organ Procurement and Transplantation Network Act
  • H.R. 2666, theMedicaid VBPs for Patients (MVP) Act
  • H.R. 3285, theFairness for Patient Medications Act
  • H.R. 3284, theProviders and Payers COMPETE Act
  • H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug

discount program

 

Sanders Drafting $200 Billion Health Package

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) plans to propose a nearly $200 billion health care package that includes $130 billion in funding for community health centers and $60 billion to strengthen the health care workforce. While the HELP Committee has been working on a bipartisan basis on several health care related issues, Ranking Member Bill Cassidy (R-La.) indicated that the total amount of funding included in the Chairman’s plan may be too steep to garner Republican support. Funding for community health centers will expire on September 30th if the program is not reauthorized before the end of the fiscal year. In the House of Representatives, leadership has reached an agreement to increase money for community health centers by approximately 5% over two years – a small fraction of the amount that has been proposed by Sanders.

 

Lawmakers Press MA Insurers on Claims Denials

Republicans on the House Energy and Commerce Committee have sent aletterto the CEO of The Cigna Group requesting an explanation of how the insurance company uses an automated system to deny medical claims without reading them. The request is in response to an investigative report by ProPublica focusing on Cigna’s procedure-to- diagnosis (PXDX) review process. The lawmakers highlight that 80% of Medicare Advantage (MA) coverage denials were overturned, suggesting that Cigna’s PXDX review process is leading to patients paying out-of-pocket for medical care that should be covered under their insurance policy contract. Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.) ask Cigna to provide documents related to the PXDX process.

The Senate Homeland Security and Governmental Affairs Committee (HSGAC) is conducting its own investigation into the frequency of MA claims denials and the role that artificial intelligence (AI) plays in coverage determinations. The panel sent letters to the three largest MA insurers – Humana, United Healthcare, and CVS – asking for data on their number of prior authorization requests and denials since 2019. The lawmakers also ask for information about the use of software algorithms to deny prior authorization requests. HSGAC’s Permanent Subcommittee on Investigations also convened a hearing last week to consider the subject of health care denials and delays in the MA program.

 

NIH Nominee to Face Questions on Drug Pricing, EcoHealth Grants

President Joe Biden announced the nomination of National Cancer Institute Director Monica Bertagnolli to lead the National Institutes of Health (NIH). Bertagnolli’s nomination is subject to Senate confirmation. While there is not yet a timeline for consideration of her nomination, Senate HELP Committee Chairman Bernie Sanders (I-Vt.)wrotePresident Biden last month to say that he “will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country.” Republicans, including Ranking Member Bill Cassidy (R-La.), are expected to discuss with Bertagnolli the origins of the coronavirus pandemic and NIH grants to EcoHealth Alliance.

 

Scott Files Paperwork to Run for President

Sen. Tim Scott (R-S.C.) has filed paperwork with the Federal Election Commission to enter the 2024 presidential race. He is expected to formally launch his campaign on Monday. The GOP field currently includes former President Donald Trump, former U.S. ambassador to the United Nations Nikki Haley, entrepreneur Vivek Ramaswamy, former Arkansas Governor Asa Hutchinson, and conservative radio host Larry Elder. Scott has served in the Senate since 2013 and is currently a member of the Finance Committee, Health, Education, Labor, and Pensions Committee, and Special Committee on Aging. Florida Governor Ron DeSantis is expected to announce his plan to run for president mid-week.

 

GAO Releases New Report on Noncompete Agreements

The Government Accountability Office (GAO) has released a newreportdetailing its investigation into non-compete agreements, including those in the health care and social assistance employment sector. The GAO found that 57% of health care and social assistance employers surveyed require new hires to sign agreements restricting them from taking jobs with rival companies. The report was requested by Sens. Ron Wyden (D-Ore.), Elizabeth Warren (D-Mass.), Tim Kaine (D-Va.), Christopher Murphy (D-Conn.), Marco Rubio (R-Fla.), and Todd Young (R-Ind.).

 

ARPA-H Announces Inaugural Program

The Advanced Research Projects Agency for Health (ARPA-H) announced the launch of its first program last week. The Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) aims to develop breakthroughs that would allow the human body to repair its owns joints. Osteoarthritis is a leading cause of disability in the U.S. It impacts more than 32 million Americans and costs an estimated $136 billion per year. Research teams interested in in NITRO can find more information about a Proposers’ Dayhere.

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Committee hearing “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part I: Self-Interest or Health Care?” 10:00 a.m.; May 23

 

House Veterans’ Affairs Committee hearing “COVID-19 Supplemental Funding: Did It Protect and Improve Veteran Care?” 10:00 a.m.; May 23

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “VA Information Technology Contracting: Challenges in Consolidation of Competition and Conflict of Interest;” 8:00 a.m.; May 24

 

House Oversight and Accountability Subcommittee on Economic Growth, Energy Policy, and Regulatory Affairs hearing “Consumer Choice on the Backburner: Examining the Biden Administration’s Regulatory Assault on Americans’ Gas Stoves;” 10:00 a.m.; May 24

 

House Appropriations Committee markup of fiscal year 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill; 10:00 a.m.; May 24

 

House Ways and Means Subcommittee on Trade hearing “Modernizing Customs Policies to Protect American Workers and Secure Supply Chains;” 9:00 a.m.; May 25

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation field hearing “Advances in AI: Views from Silicon Valley;” 10:00 a.m.; June 1

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

S.1592 – A bill to clarify coverage of occupational therapy under the Medicare program; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.1594 – A bill to require the Secretary of Health and Human Services to convene a task force to develop strategies and coordinate efforts to eliminate preventable maternal mortality, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1595 – A bill to prohibit taxpayer-funded gender transition procedures, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Finance

 

S.1597 – A bill to amend chapter 110 of title 18, United States Code, to prohibit gender transition procedures on minors, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Judiciary

 

S.1598 – A bill to clarify and improve accountability for certain members of the Armed Forces during consideration for medical separation in the Integrated Disability Evaluation System of the Department of Defense, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Armed Services

 

S.1599 – A bill to amend the Public Health Service Act to provide for grants to promote representative community engagement in maternal mortality review committees, and for other purposes; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1601 – A bill to protect moms and babies against climate change, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1602 – A bill to provide for grants to address maternal mental health conditions and substance use disorders, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1603 – A bill to amend the Public Health Service Act to increase vaccination rates of pregnant and postpartum individuals, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1605 – A bill to authorize appropriations for data collection, surveillance, and research on maternal health outcomes during public health emergencies, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1606 – A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.404 – Expressing support for the designation of May 15, 2023, as “Prader-Willi Syndrome Awareness Day” to raise awareness of and promote research on the disorder; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3281 – To promote hospital and insurer price transparency; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.3282 – To amend title XVIII of the Social Security Act to promote transparency of common ownership interests under parts C and D of the Medicare program; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3284 – To require the Secretary of Health and Human Services to submit an annual report on the impact of certain Medicare regulations on provider and payer consolidation; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3285 – To establish patient protections with respect to highly rebated drugs; Sponsor: Griffith, H. Morgan [Rep.-R- VA-9]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.3290 – To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.3302 – To protect Moms and babies against climate change, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.3303 – To provide support for programs of the Department of Veterans Affairs relating to the coordination of maternity health care, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Veterans’ Affairs

 

H.R.3304 -To authorize appropriations for data collection, surveillance, and research on maternal health outcomes during public health emergencies, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.3305 – To end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce; Education and the Workforce; Veterans’ Affairs; Natural Resources; Judiciary

 

H.R.3310 – To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes; Sponsor: Adams, Alma S. [Rep.-D-NC-12]; Committees: House – Energy and Commerce

 

H.R.3312 – To address maternal mental health conditions and substance use disorders, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.3320 – To amend the Public Health Service Act to improve maternal health data collection processes and quality measures, and for other purposes; Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce; Natural Resources

 

H.R.3322 – To address social determinants of maternal health to eliminate maternal mortality, severe maternal morbidity, and maternal health disparities, and for other purposes; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Energy and Commerce

 

H.R.3328 – To amend chapter 110 of title 18, United States Code, to prohibit gender transition procedures on minors, and for other purposes; Sponsor: LaMalfa, Doug [Rep.-R-CA-1]; Committees: House – Judiciary

 

H.R.3329 – To prohibit taxpayer-funded gender transition procedures, and for other purposes; Sponsor: LaMalfa, Doug [Rep.-R-CA-1]; Committees: House – Energy and Commerce; Judiciary; Ways and Means

 

H.R.3346 – To direct the Administrator of the Centers for Medicare & Medicaid Services to implement the Perinatal Care Alternative Payment Model Demonstration Project to test various payment models with respect to maternity care provided to pregnant and postpartum individuals, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3347 – To prohibit the Secretary of Veterans Affairs from replacing physician anesthesiologists with certified registered nurse anesthetists under the health care system of the Department of Veterans Affairs, and for other purposes; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House – Veterans’ Affairs

 

H.R.3348 – To amend the Public Health Service Act with respect to maternal vaccination awareness and equity, and for other purposes; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce

 

H.R.3352 – To amend the Internal Revenue Code of 1986 to treat diapers as qualified medical expenses; and to prohibit States and local governments to impose a tax on the retail sale of diapers; Sponsor: Watson Coleman, Bonnie [Rep.-D- NJ-12]; Committees: House – Ways and Means; Judiciary

 

S.1607 – A bill to amend title XVIII of the Social Security Act to permit a private cause of action for damages in the case of a group health plan which fails to provide for primary payment or appropriate reimbursement; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Finance

 

S.1610 – A bill to authorize administrative absences and travel and transportation allowances for members of the Armed Forces to travel and obtain reproductive health care; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

 

S.1612 – A bill to require the Secretary of Veterans Affairs to publish a rule to implement the requirement that the Secretary be permitted to waive the limitation in law on reimbursement of veterans receiving domiciliary care in State homes; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Veterans’ Affairs

 

S.1621 – A bill to provide for an exemption from authorized strength limitations for licensed behavioral health providers; Sponsor: Ossoff, Jon [Sen.-D-GA]; Committees: Senate – Armed Services

 

S.1624 – A bill to require certain civil penalties to be transferred to a fund through which amounts are made available for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1627 – A bill to amend the Internal Revenue Code of 1986 to create a tax credit for nurse preceptors; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Finance

 

H.R.3355 – To amend the Public Health Service Act to reauthorize a loan repayment program for the substance use disorder treatment workforce, and for other purposes; Sponsor: Rogers, Harold [Rep.-R-KY-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3368 – To require the Secretary of Veterans Affairs to publish a rule to implement the requirement that the Secretary be permitted to waive the limitation in law on reimbursement of veterans receiving domiciliary care in State homes; Sponsor: Golden, Jared F. [Rep.-D-ME-2]; Committees: House – Veterans’ Affairs

 

H.R.3373 – To direct the Secretary of the Navy to take certain actions relating to improved mental health care, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Armed Services

 

H.R.3379 – To amend title XVIII of the Social Security Act to improve access to skilled nursing facilities for primary immunodeficiency patients; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3380 – To amend the Public Health Service Act to expand and improve health care services by health centers and the National Health Service Corps for individuals with a developmental disability, and for other purposes; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Energy and Commerce

 

H.R.3382 – To amend title XVIII of the Social Security Act to eliminate the coinsurance requirement for certain colorectal cancer screening tests furnished under the Medicare program; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3387 – To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for certain health coverage of newborns; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.3388 – To amend title XVIII of the Social Security Act to permit a private cause of action for damages in the case of a group health plan which fails to provide for primary payment or appropriate reimbursement; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3391 – To extend the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House – Energy and Commerce

 

S.1633 – A bill to amend title 38, United States Code, to recognize and honor the service of individuals who served in the United States Cadet Nurse Corps during World War II, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Veterans’ Affairs

 

S.1636 – A bill to amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.1653 – A bill to amend the Public Health Safety Act to establish a program to award grants to State, local, and Tribal governments to purchase and distribute anti-blood loss supplies for use in a medical emergency, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1655 – A bill to establish a Medicare-for-all national health insurance program; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Finance

 

S.1656 – A bill to protect the privacy of personal reproductive or sexual health information, and for other purposes; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Commerce, Science, and Transportation

 

S.1664 – A bill to allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1668 – A bill to improve the Organ Procurement and Transplantation Network, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.415 – Expressing support for the designation of May as “National Bladder Cancer Awareness Month”; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Energy and Commerce

 

H.Res.416 – Expressing support for the designation of the 17th day in May as “DIPG Awareness Day” to raise awareness and encourage research into cures for diffuse intrinsic pontine glioma (DIPG) and pediatric cancers in general; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.Res.419 – Expressing support for the designation of May as Ehlers-Danlos Syndrome Awareness Month to increase the knowledge of this little-known, potentially fatal, genetic disease; Sponsor: Ruppersberger, C. A. Dutch [Rep.-D-MD-2]; Committees: House – Energy and Commerce

 

H.R.3409 – To allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability

 

H.R.3412 – To authorize the Assistant Secretary for Mental Health and Substance Use, acting through the Director of the Center for Substance Abuse Treatment, to award grants to States to expand access to clinically appropriate services for opioid abuse, dependence, or addiction; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce

 

H.R.3417 – To ensure fair billing practices for items and services furnished by off-campus outpatient departments of a provider; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3420 – To protect the privacy of personal reproductive or sexual health information, and for other purposes; Sponsor: Jacobs, Sara [Rep.-D-CA-51]; Committees: House – Energy and Commerce

 

H.R.3421 – To establish an improved Medicare for All national health insurance program; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Rules; Oversight and Accountability; Armed Services; Judiciary

 

H.R.3426 – To amend the Internal Revenue Code of 1986 to include expenses relating to membership in health care sharing ministries to qualify for the deduction for medical expenses, and for other purposes; Sponsor: Kelly, Mike [Rep.-R- PA-16]; Committees: House – Ways and Means

 

H.R.3428 – To amend title 38, United States Code, to recognize and honor the service of individuals who served in the United States Cadet Nurse Corps during World War II, and for other purposes; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Veterans’ Affairs; Armed Services

 

H.R.3432 – To amend title XVIII of the Social Security Act to ensure coverage of mental and behavioral health services furnished through telehealth; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3433 – To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: McCaul, Michael T. [Rep.-R-TX-10]; Committees: House – Energy and Commerce

 

H.R.3440 – To amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.221 – A resolution promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2023, which include bringing attention to the health disparities faced by minority populations of the United States such as American Indians, Alaska Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians or other Pacific Islanders; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Voice Vote.

 

S.Res.224 – A resolution designating May 2023 as “ALS Awareness Month”; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Judiciary

 

S.1673 – A bill to amend title XVIII to protect patient access to ground ambulance services under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.1687 – A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.1691 – A bill to amend title XVIII of the Social Security Act to improve the enrollment of retiring individuals in the Medicare program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.1697 – A bill to provide for the overall health and well-being of young people, including the promotion and attainment of lifelong sexual health and healthy relationships, and for other purposes; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1698 – A bill to require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1699 – A bill to support the use of technology in maternal health care, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1700 – A bill to address mental health issues for youth, particularly youth of color, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1701 – A bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1703 – A bill to amend title XVIII of the Social Security Act to ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare part D; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

 

S.1710 – A bill to amend the Public Health Service Act to grow and diversify the perinatal workforce, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1712 – A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1729 – A bill to facilitate nationwide accessibility and coordination of 211 services and 988 services in order to provide information and referral to all residents and visitors in the United States for mental health emergencies, homelessness needs, other social and human services needs, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1745 – A bill to amend title 38, United States Code, to expand access to the Veterans Community Care Program of the Department of Veterans Affairs to include certain veterans seeking mental health or substance-use services, and for other purposes; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Veterans’ Affairs

 

S.1749 – A bill to amend title XVIII and XIX of the Social Security Act with respect to nursing facility requirements, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

H.Res.425 – Supporting the designation of July 19, 2023, as “Glioblastoma Awareness Day”; Sponsor: Mast, Brian J. [Rep.- R-FL-21]; Committees: House – Energy and Commerce

 

H.R.3471 – To preempt States from establishing, implementing, or enforcing any ban on the prescription, provision, or use of a drug, biological product, or device for contraception if such drug, biological product, or device is approved, licensed, cleared, or otherwise authorized for human use by the Food and Drug Administration for contraception, and for other purposes; Sponsor: Bice, Stephanie I. [Rep.-R-OK-5]; Committees: House – Energy and Commerce

 

H.R.3481 – To provide paid family and medical leave benefits to certain individuals, and for other purposes; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Ways and Means

 

H.R.3498 – To facilitate nationwide accessibility and coordination of 211 services and 988 services in order to provide information and referral to all residents and visitors in the United States for mental health emergencies, homelessness needs, other social and human services needs, and for other purposes; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Energy and Commerce

 

H.R.3503 – To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D- IL-2]; Committees: House – Energy and Commerce

 

H.R.3520 – To improve the provision of care and services under the Veterans Community Care Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Veterans’ Affairs

 

H.R.3523 – To grow and diversify the perinatal workforce, and for other purposes; Sponsor: Moore, Gwen [Rep.-D-WI-4]; Committees: House – Energy and Commerce

 

H.R.3532 – To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Energy and Commerce; Rules

 

H.R.3548 – To address mental health issues for youth, particularly youth of color, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

H.R.3549 – To amend title XVIII of the Social Security Act to ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare part D; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3554 – To amend title 38, United States Code, to expand access to the Veterans Community Care Program of the Department of Veterans Affairs to include certain veterans seeking mental health or substance-use services, and for other purposes; Sponsor: Zinke, Ryan K. [Rep.-R-MT-1]; Committees: House – Veterans’ Affairs

The Senate Health, Education, Labor, and Pensions (HELP) Committee markup of four drug pricing related bills was postponed last week after a disagreement between panel Democrats and Republicans about the process by which the legislation was brought forth for consideration. Republicans argued that several amendments filed by Democrats contained policies that committee leadership agreed to set aside during their initial bipartisan negotiations on the package of bills, some of which had been awaiting scores from the Congressional Budget Office and technical assistance from federal agencies. HELP Committee members also questioned why the markup was taking place prior to a related hearing scheduled for May 10 in which the nation-s largest insulin manufacturers and pharmacy benefit managers have agreed to testify. The markup has been rescheduled for Thursday, May 11.

 

Appropriations Markups to Begin Mid-May

Senate Appropriations Chair Patty Murray (D-Wash.) announced plans for her panel to begin marking up fiscal year (FY) 2024 spending legislation on May 18th. Negotiations between Murray and Ranking Member Susan Collins (R-Maine) on top-line spending levels are still ongoing. House Appropriations Committee leadership recently announced its own FY 2024 appropriations markup schedule as well: the first subcommittee markups will be held May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

 

E&C Republicans Probe Viral Manipulation Research, CDC Reorganization

Top Republicans on the House Energy and Commerce Committee are asking the Government Accountability Office to evaluate the benefits and risks of predictive field research programs for viruses. The letter comes as a part of the panel-s investigation into the origins of COVID-19. The letter was signed by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.). The lawmakers have also asked acting director of the National Institutes of Health (NIH) Lawrence Tabak to supply details about all internal and external NIH research projects involving virus manipulation.

Rodgers, Guthrie, and Griffith also sent a letter to the Centers for Disease Control and Prevention (CDC) requesting information related to its Moving Forward Initiative which has resulted in the agency undertaking a large-scale reorganization. The letter criticizes the CDC for conducting the initiative “largely in secret,” providing just a 10-day notice and comment period and only convening a single related public meeting. The agency used the findings of the Moving Forward Initiative to justify its request to Congress for additional authority to mandate data reporting from state, local, territorial, and tribal public health agencies. “The CDC must provide the Committee with more than a cursory, summarized overview of the findings of the Moving Forward Initiative before the Committee can even begin to consider the agency-s request for additional authority,” the lawmakers state.

 

Wyden, Matsui, McHenry Urge Bakers to Comply with Spirit of Sesame Labeling Law

Sen. Ron Wyden (D-Ore.), Rep. Doris Matsui (D-Calif.), and Rep. Patrick McHenry (R-N.C.) have sent a letter to the American Bakers Association urging its members to stop unnecessarily adding sesame to baked goods in order to protect consumers with a sesame allergy. “The dangerous practice of adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry,” the letter states. The lawmakers argue that “instead of acting to protect consumers, manufacturers are adding trace amounts of sesame to their baking products since the passage of the FASTER Act. It appears that this is being done to avoid the costs associated with the processes and systems controls necessary to ensure safe baking practices.” The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which became law in April 2021, requires manufacturers to ensure that products containing sesame are appropriately labeled.

 

Finance Committee Explores Prevalence of Mental Health Ghost Networks

The Senate Finance Committee released a ‘secret shopper- report last week which found that most Medicare Advantage plan mental health provider directories contain misleading or false contact information. In a study of directories across 12 different plans in six states, Finance majority staff found that more than 80% of mental health care providers listed as in- network were in fact not available to the plan-s enrollees. The report recommends increased oversight and audits of health plan directories, and suggests fining plans that do not have accurate directories. The committee released the report prior to a hearing on the prevalence of these so-called ghost networks on Wednesday, May 10.

 

Sen. Ben Cardin Will Not Seek Reelection

Sen. Ben Cardin (D-Md.), 79, announced last week that he will not seek re-election in 2024. Cardin was first elected to the Senate in 2006 following 17 years representing Maryland-s Third Congressional District in the House of Representatives. He currently serves as Chair of the Small Business and Entrepreneurship Committee and is a senior member of the Senate Foreign Relations, Finance, and Environment and Public Works committees. Rep. David Trone (D- Md.) and Montgomery County Council member Will Jawando (D) have announced that they will run for Cardin-s Senate seat, and Prince George-s County Executive Angela Alsobrooks (D) is also considering a bid in the 2024 election.

 

WHO Declares End of COVID-19 Global Health Emergency; U.S. PHE to End May 11

At the recommendation of the World Health Organization-s (WHO) COVID-19 Emergency Committee, WHO Director-General Tedros Adhanom Ghebreyesus has declared an end to COVID-19 as a Public Health Emergency of International Concern. WHO officials were careful to emphasize that while the emergency phase of the coronavirus pandemic is over, COVID-19 remains a global public health threat. “COVID has changed our world and it has changed us,” Tedros said. “If we all go back to how things were before COVID-19, we will have failed to learn our lessons and we will have failed future generations.”

As previously announced, the Biden administration will officially terminate the U.S. COVID-19 public health emergency (PHE) on May 11. The end of the PHE declaration will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will continue to be able to access vaccines and treatments at no out-of-pocket cost through 2024. Vaccines will remain free in Medicare, Medicaid, and the Children-s Health Insurance Program, but beneficiaries of these programs could face increased cost sharing for COVID-19 tests and treatments. Certain other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extended certain telehealth policies and hospital at home waivers through 2024.

Experts have warned that there is an approximately 20% chance of an outbreak rivaling the intensity of the omicron variant occurring in the next two years. It was reported last week that scientists shared their analysis of the possibility of the virus mutating in such a way that evades vaccines and treatments with the Biden administration as it was working to wind down the PHE. The White House declined to comment about the experts- analysis.

 

Walensky to Leave Post of CDC Director

Rochelle Walensky will leave her position as Director of the Centers for Disease Control and Prevention (CDC), a post she has held since the start of the Biden administration. During her time as director Walensky acknowledged the CDC-s shortcomings in response to the COVID-19 pandemic and launched an effort to reorganize and modernize the agency. Walensky plans to step down on June 30 but did not provide a reason behind her decision to resign.

 

Tanden Tapped as Next Head of the Domestic Policy Council

According to recent reports, President Joe Biden will soon name Neera Tanden as the next Director of the Domestic Policy Council. Tanden will replace Susan Rice, who has announced her plans to leave the administration later this month. Tanden currently serves as White House staff secretary and senior adviser. She was previously nominated to lead the Office of Management and Budget but withdrew from consideration after bipartisan objections to her use of Twitter to criticize political opponents. Biden aide Stef Feldman will replace Tanden as staff secretary.

 

DEA Temporarily Extends COVID-19 Telehealth Prescribing Flexibilities

The Drug Enforcement Administration (DEA) announced last week that it will continue to permit providers to prescribe controlled substances via telehealth as the agency works to finalize its related proposed regulations in response to the end of the COVID-19 public health emergency (PHE). The rules proposed in February would have allowed doctors to prescribe only an initial 30-day supply of certain DEA-regulated drugs through telehealth. For other drugs – including Adderall – patients would be required to complete an in-person visit with a provider before receiving a prescription. The DEA stated that it received a record number of comments in response to the proposed rules. It did not specify how long the temporary extension of the COVID-19 era flexibilities will last.

In related news, a bipartisan group of senators sent a letter to the DEA calling on the agency to address gaps in patient access to the opioid use disorder drug buprenorphine. “We are concerned that the DEA has failed to develop and provide sufficiently clear guidance for pharmacists, wholesalers, distributors, and patients for accessing buprenorphine,” the lawmakers said in a letter to the agency. The letter was signed by Sens. Maggie Hassan (D-N.H.), Martin Heinrich (D-N.M.), Thom Tillis (R-N.C.), Elizabeth Warren (D-Mass.) and Sheldon Whitehouse (D-R.I.).

New Survey Examines Impact of Pandemic on Nursing Shortages

Anew survey from AMN Healthcare reveals that nearly one-third of nurses nationwide will leave the profession because of the COVID-19 pandemic. The percentage of nurses saying they were satisfied with their choice of career dropped to 71% in 2023, after holding steady at 80% to 85% for the prior decade. The survey of 182,000 nurses also found a decline in the percentage of nurses who are satisfied with the quality of care they provide from 75% to 64%.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

House Ways and Means Committee field hearing on “Trade in America: Securing Supply Chains and Protecting the American Worker – Staten Island;” 10:00 a.m.; May 9

 

House Veterans- Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; May 9

 

House Transportation & Infrastructure Subcommittee on Highways and Transit hearing “Freight Forward: Overcoming Supply Chain Challenges to Deliver for America;” 10:00 a.m.; May 10

 

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m.; May 10

 

House Ways and Means Subcommittee on Health hearing on Examining Policies that Inhibit Innovation and Patient Access; 2:00 p.m.; May 10

 

House Select Subcommittee on the Coronavirus Pandemic hearing “Investigating Pandemic Immunity: Acquired, Therapeutic or Both;” 10:00 a.m.; May 11

 

Senate Health, Education, Labor, and Pensions Committee markup of S. 1067, Ensuring Timely Access to Generics Act of 2023, S. 1114, Expanding Access to Low-Cost Generics Act of 2023, S. 1214, RARE Act, and S. 1339, Pharmacy Benefit Manager Reform Act; 10:00 a.m.; May 11

 

House Energy and Commerce Subcommittee on Health hearing “Preparing for and Responding to Future Public Health Security Threats;” 10:00 a.m.; May 11

 

Senate Finance Committee hearing “Cross-border Rx: Pharmaceutical Manufacturers and U.S. International Tax Policy;” 10:00 a.m.; May 11

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains;” 10:30 a.m.; May 11

 

House Transportation & Infrastructure Subcommittee on Railroads, Pipelines, and Hazardous Materials hearing “Getting Back on Track: Exploring Rail Supply Chain Resilience and Challenges;” 2:00 p.m.; May 11

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “FDA Oversight Part II: Responsibility for the Infant Formula Shortage;” 2:00 p.m.; May 11

 

Recently Introduced Health Legislation

 

H.R.3030 – To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes. Sponsor: Sorensen, Eric [Rep.-D-IL-17]; Committees: House – Energy and Commerce

 

H.R.3029 – To amend the Internal Revenue Code of 1986 to allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts, and for other purposes. Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means

 

H.R.3024 – To amend the Family and Medical Leave Act of 1993 to permit additional leave for bone marrow or blood stem cell donation, and for other purposes. Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration

 

H.R.3023 – To direct the Secretary of Veterans Affairs and the Secretary of Defense to furnish stellate ganglion block to veterans and members of the Armed Forces with post-traumatic stress disorder, and for other purposes. Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Armed Services; Veterans- Affairs

 

H.R.3017 – To amend title XVIII of the Social Security Act to improve access to skilled nursing facilities for primary immunodeficiency patients. Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3011 – To establish a task force of the Department of Defense on mental health. Sponsor: Kilmer, Derek [Rep.-D- WA-6]; Committees: House – Armed Services

 

H.R.3009 – To direct the Secretary of Defense to carry out a pilot program to pre-program suicide prevention resources into certain smart devices issued to members of the Armed Forces. Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Armed Services

 

H.R.3008 – To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. Sponsor: Jacobs, Sara [Rep.-D-CA-51]; Committees: House – Energy and Commerce

 

H.R.3004 – To amend the Internal Revenue Code of 1986 to provide for a temporary expansion of health insurance premium tax credits for certain low-income populations, and to amend title XIX of the Social Security Act to establish a Federal Medicaid program. Sponsor: Fletcher, Lizzie [Rep.-D-TX-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.Res.347 – Expressing support for designation of the mouth of April 2023 as “Parkinson-s Awareness Month”. Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House – Energy and Commerce

 

H.Res.345 – Recognizing that infertility is a widespread problem that affects populations of diverse ages, races, ethnicities, and genders. Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]; Committees: House – Energy and Commerce

 

H.Res.338 – 118th Congress (2023-2024) Expressing support for the designation of April 30, 2023, as “National Adult Hepatitis B Vaccination Awareness Day”. Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]; Committees: House – Energy and Commerce

 

S.1395 – A bill to temporarily suspend the debt limit through December 31, 2024; Sponsor: Schumer, Charles E. [Sen.- D-NY]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

 

S.1403 – A bill to amend the Public Health Service Act to establish a grant program to award grants to accredited public institutions of higher education, and for other purposes; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.348 – Declaring gun violence a public health crisis; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Energy and Commerce

 

H.Res.351 – Recognizing the impact the stigmatization of menstruation has on the lives of women, girls, and people who menstruate, and expressing support for the designation of the month of May as “National Menstrual Health Awareness Month”; Sponsor: Meng, Grace [Rep.-D-NY-6]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.355 – Supporting the designation of May 2023 as “National Brain Tumor Awareness Month”; Sponsor: Quigley, Mike [Rep.-D-IL-5]; Committees: House – Energy and Commerce

 

H.R.3055 – To amend the Elementary and Secondary Education Act of 1965 to include certain mental health professionals as specialized instructional support personnel; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Education and the Workforce

 

H.R.3065 – To amend the Public Health Service Act to provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose, and for other purposes; Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Energy and Commerce

 

H.R.3066 – To establish the National Commission on the COVID-19 Pandemic, and for other purposes; Sponsor: Posey, Bill [Rep.-R-FL-8]; Committees: House – Energy and Commerce; Financial Services; Transportation and Infrastructure

 

H.R.3068 – To prohibit discrimination in health care and require the provision of equitable health care, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3069 – To amend title XI of the Social Security Act to improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3073 – To amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to promote mental wellness and resilience and prevent and heal mental health, behavioral health, and psychosocial conditions through developmentally and culturally appropriate community programs, and award grants for the purpose of establishing, operating, or expanding community-based mental wellness and resilience programs, and for other purposes; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3074 – To amend title XIX of the Social Security Act to remove the Medicaid coverage exclusion for inmates in custody pending disposition of charges, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.3076 – To amend title 36, United States Code, to direct the Secretary of Veterans Affairs to establish a flag for next of kin of veterans who die by suicide; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Judiciary

 

H.R.3077 – To amend title 38, United States Code, to establish a counseling program for certain survivor of veterans deceased as the result of suicide; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Veterans- Affairs

 

S.1423 – A bill to amend the Public Health Service Act to authorize a scholarship and loan repayment program to incentivize physicians to enter into the field of sickle cell disease research, treatment, and patient care, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1424 – A bill to amend title XXVII of the Public Health Service Act to improve health care coverage under vision and dental plans, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1426 – A bill to improve the identification and support of children and families who experience trauma; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1436 – A bill to expand and extend benefits available to veterans in response to the COVID-19 pandemic, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans- Affairs

 

S.Res.197 – A resolution designating the week of May 1, 2023, through May 7, 2023, as “Tardive Dyskinesia Awareness Week”; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Judiciary

 

S.1441 – A bill to establish a Center for Biomedical Innovation and Development in order to accelerate innovation and development of advanced medical countermeasure products; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1446 – A bill to amend the Internal Revenue Code of 1986 to exclude certain Nurse Corps payments from gross income; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Finance

 

S.1447 – A bill to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1450 – A bill to establish a cap on costs for covered prescription drugs under Medicare parts B and D; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Finance

 

S.1451 – A bill to band anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1452 – A bill to promote mental wellness and resilience and prevent and heal mental health, behavioral health, and psychosocial conditions through developmentally and culturally appropriate community programs, and award grants for the purpose of establishing, operating, or expanding community-based mental wellness and resilience programs, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

House Passes GOP Debt Ceiling Bill Along Party Lines

The House of Representatives passed the GOP leadership’s legislative proposal to raise the debt ceiling last week in a 217-215 vote. Four Republicans – Matt Gaetz (Fla.), Andy Biggs (Ariz.), Ken Buck (Colo.), and Tim Burchett (Tenn.) – joined Democrats in opposition to the measure. The Limit, Save, Grow Act of 2023 (H.R. 2811) would lift the nation’s $34.1 trillion debt limit by $1.5 trillion or until March 31, 2024, whichever comes first, in exchange for $130 billion in proposed budget cuts. The bill would achieve these cuts by freezing discretionary spending at fiscal year (FY) 2022 levels – $1.47 trillion. Any future spending increases would be capped at 1% annually for the next decade, reaching $1.61 trillion in total discretionary spending in FY 2033. The bill would permit new budget authority only for certain activities, including health care fraud and abuse prevention. The legislation also includes provisions to claw back unspent and unobligated COVID-19 funding and to institute work requirements for social safety net programs. Medicaid recipients would be required to work, look for work, or participate in community engagement for 80 hours a month, exempting those with dependent children and those who are “physically or mentally unfit,” enrolled in an educational program, under 19 years old, or over 56 years old. The Congressional Budget Office estimates that the bill would reduce the federal deficit by $4.8 trillion over the next decade. The Medicaid work requirement proposal would reduce federal spending by $109 billion, with the budget office forecasting that 1.5 million adults would lose federal funding for their Medicaid coverage. Approximately 900,000 of those individuals would retain their health insurance coverage through Medicaid state funding, while 600,000 would become uninsured. H.R. 2811 has been rejected by congressional Democrats and the White House in favor of a clean increase to the debt limit, with Majority Leader Chuck Schumer (D-N.Y.) characterizing the bill as dead on arrival in the Senate and the White House confirming that the President would veto the legislation should it reach his desk. Without an increase or suspension of the debt ceiling, the nation could default on its payment obligations as early as June.

 

HELP to Markup Four Drug Pricing Bills This Week

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have announced a bipartisan deal to consider a slate of drug pricing related proposals. The four bills will be marked up by the panel on Tuesday. The committee will consider:

• The RARE Act (S. 1214), to codify that the scope of orphan drug exclusivity aligns with the approved use or indication of an orphan drug, rather than the disease or condition for which the drug received orphan drug designation.
• The Ensuring Timely Access to Generics Act of 2023 (S. 1067), which would permit the FDA to deny a citizen petition submitted with the primary purpose of delaying the approval of a follow-on generic or biosimilar application, or if the petition does not raise valid scientific or regulatory issues.
• The Expanding Access to Low-Cost Generics Act of 2023 (S. 1114), to allow generic companies that are not “first filers” to enter the market if the first filer who otherwise received 180-day exclusivity has failed to come to market by 33 months since the date of submission of the application when there is another applicant who is otherwise ready to market their product.
• The Pharmacy Benefit Manager Reform Act (S. 1339), which would increase oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage.

Senate Majority Leader Chuck Schumer (D-N.Y.) aims to bring a drug pricing package to the floor this year. The Senate Commerce, Judiciary, and Finance committees are also working to pass their own drug pricing proposals, and Sanders has stated that he expects to see several of the related bills merged when they reach the Senate floor.

 

House Appropriations Markups to Commence May 17th

The House Appropriations Committee will begin conducting markups of FY 2024 spending bills later this month. According to a letter from Chairwoman Kay Granger (R-Texas) to panel members, the first subcommittee markups will be scheduled for May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

 

Senate Republicans Block VA Cannabis Research Proposal

The Senate blocked consideration of legislation last week that would have directed the Department of Veterans Affairs (VA) to conduct research on the effects of cannabis on patients in the VA health care system suffering from trauma, stress, chronic pain, and opioid use disorder. The VA Medicinal Cannabis Research Act (S. 326), introduced by Sens. Jon Tester (D-Mont.) and Dan Sullivan (R-Alaska), was unanimously passed out of committee earlier this year but failed in a 57-42 procedural motion that required 60 votes to advance on the Senate floor. Eight Republicans joined Democrats in support of the bill: Veterans’ Affairs Committee members Jerry Moran (Kansas), Bill Cassidy (La.), Mike Rounds (S.D.), and Dan Sullivan (Alaska), along with Susan Collins (Maine), Lisa Murkowski (Alaska), Josh Hawley (Mo.), and Eric Schmitt (Mo.).

 

Warren, Jayapal Make Drug Pricing Recommendations for USPTO

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have sent a letter to the U.S. Patent and Trademark Office (USPTO) reiterating their request that the agency take action against alleged efforts by pharmaceutical manufacturers to prevent generic competition from coming to market. “We have yet to see the USPTO take substantial steps to exercise its existing administrative authorities to help lower drug prices, encourage competition, and increase innovation,” the letter states. The lawmakers sent similar letters to the agency in June 2021 and December 2022. Warren and Jayapal specifically urge the USPTO to consider the following recommendations:

• Revise the practice of granting obvious patents;
• When challenged, patents tied together by terminal disclaimers should all stand or fall together;
• Raise filing fees and limit the number and time period for continuation applications to discourage “obviousness-type double patents;”
• Require applicants to disclose at the time of filing whether the drug compound covered by the patent application is in clinical trials;
• Reverse policies that have led to an increase in discretionary denials of petitions filed through the inter partes review process; and
• Establish an office dedicated to building public transparency, serving the public interest, and strengthening interagency communication.

 

Coronavirus Select Subcommittee Requests Intel from Chinese Scientists

Republicans on the House Select Subcommittee on the Coronavirus Pandemic have asked the Chinese embassy to permit five Chinese scientists to be interviewed about how the coronavirus pandemic started. The request comes in response to the Chinese embassy’s opposition to a recent subcommittee hearing regarding the origins of COVID-19. “Continued stonewalling by China will not only harm the globe’s ability to predict, prepare, protect, and prevent the next pandemic but will also…fail to promote ‘international solidarity,'” the letter states. The committee asks to hear from Dr. George Gao, former director of the Chinese Center for Disease Control and Prevention; Dr. Shi Zhengli, director of the Center for Emerging Infectious Diseases, the Wuhan Institute of Virology; Dr. Ben Hu, a researcher with the Wuhan Institute of Virology; and Dr. Chen Wei, Major General of the People’s Liberation Army.

 

E&C Republicans Launch Probe into NIH Communications Spending

House Energy and Commerce Committee Republicans have launched an investigation into spending by the National Institutes of Health (NIH) on public information and communication services. The NIH has spent nearly $1 billion over the last five years on public relations contracts. The committee sent letters to the 10 communications and consulting firms awarded a contract in 2018 that is due to expire in December to request more information about their work for NIH. “Government contracts for public relations, consulting, and media services can devolve into a kind of de facto public relations service for the personal aggrandizement of senior leadership. They can be used to promote an agency’s brand and image instead of being used to communicate accurate information to the public,” the letter states. The panel aims to determine how the agency uses contract public relations firms and whether they are an appropriate use of taxpayer dollars.

 

Physicians Consider Impact of Potential Mifepristone Restrictions on Off-Label Prescribing

Physicians across the country are working to determine the impact of recent legal rulings related to the accessibility of mifepristone on their prescribing practices. Earlier this month, the Supreme Court acted to prevent lower court rulings suspending access to mifepristone from taking effect. Mifepristone is approved by the Food and Drug Administration (FDA) for abortion, though it is frequently prescribed off-label for miscarriage management. The U.S. 5th Circuit Court of Appeals will hear arguments on May 17 from anti-abortion groups in support of overturning the FDA’s approval of mifepristone and counterarguments from the Biden administration and the pill’s manufacturer seeking to maintain access to the pill nationwide. The 5th Circuit’s prior ruling would have kept the drug on the market but restricted access to telemedicine prescriptions, mail delivery, pharmacy dispensing, and generic versions of the drug and only permitted prescriptions within seven weeks of gestation. Meanwhile, a separate federal court ruling from Washington state could shield some states and the District of Columbia from any attempts to restrict mifepristone availability. While some legal experts assert that any future restrictions on the medication abortion pill could be circumvented by prescribing the drug off-label, many prescribers are concerned about the possibility of prosecution, harassment, and retaliation from state licensing boards and civil litigation. “We don’t feel at all comfortable,” American Medical Association President Jack Resneck stated in an interview. “Off-label prescribing is common, but it is really unclear in this case what physicians would be able to do.”

 

Upcoming Congressional Hearings and Markups

 

Senate Health, Education, Labor, and Pensions Committee markup of S. 1067, Ensuring Timely Access to Generics Act of 2023, S. 1114, Expanding Access to Low-Cost Generics Act of 2023, S. 1214, RARE Act, and S. 1339, Pharmacy Benefit Manager Reform Act; 10:00 a.m.; May 2

 

Senate Finance Committee hearing “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks;” 10:00 a.m.; May 3

 

Senate Veterans’ Affairs Committee hearing “Examining the Effectiveness of the Office of Integrated Veteran Care;” 3:00 p.m.; May 3

 

Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies hearing “Fiscal Year 2024 budget for the National Institutes of Health;” 10:00 a.m.; May 4

 

Senate Health, Education, Labor, and Pensions Committee hearing “Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act;” 1:00 p.m.; May 4

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; May 9

 

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m.; May 10

 

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.2804 – To amend the Controlled Substances Act with respect to the registration of opioid treatment programs to increase stakeholder input from relevant communities and to ensure such programs are treating patients in need, and for other purposes; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2809 – To authorize an electronic health record modernization program of the Department of Veterans Affairs and increase oversight and accountability of the program to better serve veterans, medical professionals of the Department, and taxpayers, and for other purposes; Sponsor: Takano, Mark [Rep.-D-CA-39]; Committees: House – Veterans’ Affairs; Armed Services

 

S.Res.170 – A resolution supporting the goals and ideals of World Malaria Day; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate – Foreign Relations

 

S.1262 – A bill to amend title 5, United States Code, to require Federal employee health benefit plans to include assisted reproductive treatment benefits, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.1264 – A bill to amend title XVIII of the Social Security Act to strengthen the drug pricing reforms in the Inflation Reduction Act; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

S.1269 – A bill to reduce the price of insulin and provide for patient protections with respect to the cost of insulin; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.2813 – To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans, and for other purposes; Sponsor: Good, Bob [Rep.-R- VA-5]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.R.2816 – To amend title XI of the Social Security Act to strengthen transparency requirements with respect to pharmacy benefit managers; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2818 – To amend title 38, United States Code, to increase the amount paid by the Secretary of Veterans Affairs to veterans for improvements and structural alterations furnished as part of home health services; Sponsor: Bacon, Don [Rep.-R-NE-2]; Committees: House – Veterans’ Affairs

 

H.R.2819 – To amend the Public Health Service Act to limit the liability of health care professionals who volunteer to provide health care services in response to a disaster; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2828 – To require Federal employee health benefit plans to include assisted reproductive treatment benefits, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Oversight and Accountability

 

H.R.2829 – To amend title XVIII of the Social Security Act to remove cost-sharing responsibilities for chronic care management services under the Medicare program; Sponsor: Duncan, Jeff [Rep.-R-SC-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2852 – To require the Secretary of Defense to provide to firefighters of the Department of Defense medical testing and related services to detect and prevent certain cancers; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.2853 – To amend title XVIII of the Social Security Act to expand access to clinical care in the home, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2854 – To require the Administrator of the United States Agency for International Development to submit a report on progress relating to malaria reduction, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Foreign Affairs

 

H.R.2857 – To direct the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services to conduct an annual study on health care competition and consolidation at the State level; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce

 

H.R.2858 – To amend the Pension Funding Equity Act of 2004 to repeal the antitrust exemption applicable to graduate medical resident matching programs; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Judiciary

 

H.R.2859 – To amend the Internal Revenue Code of 1986 to establish new community benefit standards for tax-exempt hospital organizations, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Ways and Means

 

H.R.2860 – To amend title XVIII of the Social Security Act to repeal the Obamacare ban on provider-owned hospitals, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2861 – To require the Government Accountability Office to evaluate the effects of anticompetitive contracting clauses in contracts between health insurers and health care providers and to determine actions taken by the Federal Trade Commission and the Department of Justice relating to the use of such clauses in such contracts and to assess their ability to effectively enforce the Federal antitrust laws with respect to such use; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2862 – To eliminate the inpatient-only service list; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2863 – To amend title XVIII of the Social Security Act and title XXVII of the Public Health Service Act to address incorrect billing by off-campus hospital locations, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2867 – To establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Drugs, and to provide community-based coalition enhancement grants to mitigate the effects of drug use; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.2868 – To amend the Employee Retirement Income Security Act of 1974 to clarify the treatment of certain association health plans as employers, and for other purposes; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Education and the Workforce

 

S.1294 – A bill to provide for payment rates for durable medical equipment under the Medicare program; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.1296 – A bill to amend title XI of the Social Security Act to improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1297 – A bill to ensure the right to provide reproductive health care services, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Judiciary

 

S.1298 – A bill to award grants for the creation, recruitment, training and education, retention, and advancement of the direct care workforce and to award grants to support family caregivers; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1302 – A bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1315 – A bill to improve the provision of care and services under the Veterans Community Care Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans’ Affairs

 

S.1317 – A bill to amend the Public Health Service Act to provide for public health research and investment into understanding and eliminating structural racism and police violence; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.2880 – To amend title XVIII of the Social Security Act to establish certain requirements for pharmacy benefit managers under part D of the Medicare program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2884 – To facilitate direct primary care arrangements under Medicaid; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

H.R.2890 – To amend the Federal Trade Commission Act to make hospital organizations and cooperative hospital service organizations subject to the law relating to unfair methods of competition; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Judiciary

 

H.R.2893 – To amend title XVIII of the Social Security Act to provide for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare program, and for other purposes; Sponsor: Lee, Susie [Rep.-D-NV-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2904 – To amend the Public Health Service Act to provide for public health research and investment into understanding and eliminating structural racism and police violence; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Energy and Commerce

 

H.R.2907 – To ensure the right to provide reproductive health care services, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2914 – To amend the Internal Revenue Code of 1986 to extend the health coverage tax credit; Sponsor: Turner, Michael R. [Rep.-R-OH-10]; Committees: House – Ways and Means

 

S.Res.180 – A resolution expressing support for the designation of April 30, 2023, as “National Adult Hepatitis B Vaccination Awareness Day”; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.184 – A resolution expressing support for the designation of April 2023 as “Parkinson’s Awareness Month”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1333 – A bill to authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for providing evidence-based caregiver skills training to family caregivers of children with autism spectrum disorder or other developmental disabilities or delays, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1339 – A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1346 – A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Center for Mental Health Services of the Substance Abuse and Mental Health Services Administration, to award grants to implement innovative approaches to securing prompt access to appropriate follow-on care for individuals who experience an acute mental health episode and present for care in an emergency department, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1347 – A bill to amend title 10, United States Code, to waive cost-sharing under the TRICARE program for three mental health outpatient visits per year for certain beneficiaries, and for other purposes; Sponsor: Ossoff, Jon [Sen.-D-GA]; Committees: Senate – Armed Services

 

S.1355 – A bill to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections, and for other purposes; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1360 – A bill to require the Secretary of Defense to include exposure to perfluoroalkyl substances and polyfluoroalkyl substances in periodic health assessments of members of the Armed Forces, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

 

S.1367 – A bill to amend XIX of the Social Security Act to cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care, to amend title XVIII of such Act to modify the requirements for diabetic shoes to be included under Medicare, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.1373 – A bill to increase access to medication for opioid overdose reversal, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1374 – A bill to prohibit group health plans and health insurance issuers from entering into contracts that would prevent or restrict patient access to drug pricing information otherwise available through consumer decision-support tools; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1375 – A bill to amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1378 – A bill to amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.1384 – A bill to promote and protect from discrimination living organ donors; Sponsor: Gillibrand, Kirsten E. [Sen.-D- NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.333 – Expressing support for designation of April as “National Donate Life Month” and expressing gratitude to all Americans who have registered to be organ and tissue donors; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House – Energy and Commerce

 

H.R.2923 – To promote and protect from discrimination living organ donors; Sponsor: Nadler, Jerrold [Rep.-D-NY-12]; Committees: House – Energy and Commerce; Oversight and Accountability; House Administration; Education and the Workforce; Financial Services

 

H.R.2935 – To amend title 10, United States Code, to extend the period during which certain survivors of a member of the Selected Reserve are eligible for health benefits under TRICARE Reserve Select; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Armed Services

 

H.R.2940 – To amend title III of the Public Health Service Act to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections, and for other purposes; Sponsor: Ferguson, A. Drew, IV [Rep.-R-GA-3]; Committees: House – Energy and Commerce; Oversight and Accountability; Ways and Means; Budget

 

H.R.2959 – To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

 

H.R.2965 – To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for providing evidence-based caregiver skills training to family caregivers of children with autism spectrum disorder or other developmental disabilities or delays, and for other purposes; Sponsor: Meng, Grace [Rep.-D-NY-6]; Committees: House – Energy and Commerce

 

H.R.2977 – To direct the Secretary of Health and Human Services to award grants for the purpose of establishing, operating, or expanding one-stop crisis facilities, and for other purposes; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce; Financial Services; Judiciary

 

H.R.2986 – To amend the Internal Revenue Code of 1986 to provide a deduction for certain charity care furnished by physicians, and for other purposes; Sponsor: Webster, Daniel [Rep.-R-FL-11]; Committees: House – Ways and Means

House GOP leadership released their legislative proposal to lift the nation’s $34.1 trillion debt limit by $1.5 trillion or until March 31, 2024, whichever comes first, in exchange for $130 billion in proposed budget cuts. The Limit, Save, Grow Act of 2023 would achieve these cuts by freezing discretionary spending at fiscal year (FY) 2022 levels – $1.47 trillion. Any future spending increases would be capped at 1% annually for the next decade, reaching $1.61 trillion in FY 2033. The bill would permit new budget authority only for certain activities, including health care fraud and abuse prevention. The legislation also includes provisions to claw back unspent and unobligated COVID-19 funding and to institute work requirements for social safety net programs. House Speaker Kevin McCarthy (R-Calif.) estimated that the bill would cut budget deficits by $4.5 trillion over the next ten years.

The proposal has been rejected by Democrats in favor of a clean increase to the debt limit. Both the White House and congressional Democrats have also expressed strong opposition to the health provisions of the proposal, which would require Medicaid recipients to work, look for work, or participate in community engagement for 80 hours a month, exempting those with dependent children and those who are “physically or mentally unfit”, enrolled in an educational program, under 19 years old, or over 56 years old. Senate Majority Leader Chuck Schumer (D-N.Y.) stated that the GOP bill has no chance of moving through the Senate, where Sen. Joe Manchin (D-W.Va.) is the only Democrat who is not calling for Congress to move a clean debt ceiling increase. Manchin has praised Speaker McCarthy for putting forth a debt ceiling proposal and criticized President Biden for refusing to negotiate with Republicans on the debt limit.

The House GOP plans to hold a vote on the measure this week, but it remains unclear whether Republicans have the necessary support within their own caucus to pass the legislation. The GOP can afford to lose only four votes given unified Democratic opposition to the proposal. Several Republican members, including Reps. Tim Burchett (R-Tenn.), Victoria Spartz (R-Ind.), and Brian Fitzpatrick (R-Pa.), have stated that they remain undecided on the bill. Without an increase or suspension of the debt ceiling the nation could default on its payment obligations as early as June.

 

HELP, Finance Hope to Advance Bipartisan Health Care, PBM Legislation in Coming Weeks

Bipartisan leadership of the Senate Health, Education, Labor and Pensions (HELP) Committee and Senate Finance Committee have begun previewing their plans to advance health care related legislation in the coming weeks. The HELP Committee is expected to soon schedule a markup of a legislative package that could contain policies focused on pharmacy benefit managers (PBMs), strengthening generic drug and biosimilar competition, supporting the health care workforce, and capping the cost of insulin for individuals with private health insurance. The panel has also scheduled a hearing for May 10 in which the nation’s three main manufacturers of insulin products have agreed to testify alongside representatives from the country’s major PBMs. The CEOs of Eli Lilly and Company, Novo Nordisk, and Sanofi – which control 90% of the insulin market – will be in attendance. PBM industry executives from CVS Health, Express Scripts, and OptumRx will also testify. Chairman Bernie Sanders (I-Vt.) highlighted the hearing as the latest step in his push to make insulin more affordable and to lower the price of all prescription drugs.

While HELP has jurisdiction over the commercial health insurance market, the Finance Committee manages policies impacting federal health programs. Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) released their proposed framework for legislation that aims to “modernize and enhance” federal prescription drug programs while reducing drug costs for patients and taxpayers last week. The framework identifies the following challenges facing the nation’s prescription drug programs: misaligned incentives that drive up prices and costs, insufficient transparency that distorts the market, hurdles to pharmacy access, and behind-the-scenes practices that impede competition and increase costs. Their proposal includes the following potential policy solutions:

• Delinking PBM compensation from drug prices;
• Enhancing PBM accountability to health plan clients;
• Ensuring discounts negotiated by PBMs produce meaningful savings for seniors;
• Addressing and mitigating practices that unfairly inflate the prices patients and government programs pay for prescription drugs;
• Modernizing Medicare’s “Any Willing Pharmacy” requirements; and
• Increasing transparency around how financial flows across the prescription drug supply chain impact government health care programs.
• According to recent reports, the emerging health care packages from HELP and Finance have the potential to be combined with bipartisan drug patent legislation advanced by the Senate Commerce and Judiciary committees earlier this year.

 

Constituents Call for Feinstein Resignation Amidst Extended Absence from Senate

Acoalition of more than 60 progressive grassroots organizations representing more than 100,000 Californians have sent a letter to Sen. Dianne Feinstein (D-Calif.) urging her to resign. Her resignation would allow California Governor Gavin Newsom to appoint an interim senator to serve through the 2024 election. The groups argue that Feinstein’s extended absence from the Senate following her shingles diagnosis in February and subsequent hospitalization have impeded the Democratic Senate majority from advancing the President’s agenda. Democrats currently hold a 51-49 majority in the Senate, and Feinstein’s vote may soon be necessary to confirm Julie Su as secretary of the Department of Labor and to raise or suspend the debt limit. Her absence has also deadlocked the Judiciary Committee and impacted the panel’s ability to consider the President’s judicial nominations and subpoena hearing witnesses. Republicans blocked an attempt by Senate Majority Leader Chuck Schumer (D-N.Y.) to allow Sen. Ben Cardin (D-Md.) to temporarily fill Feinstein’s position on the Judiciary Committee last week. Feinstein is also a member of the Senate Appropriations Committee, and her absence could impact markups of fiscal year 2024 spending legislation. Feinstein’s office has not provided an estimated return date for the 89-year-old senator.

 

President Expected to Announce NIH Nominee This Week

President Joe Biden is expected to announce his nomination of National Cancer Institute (NCI) Director Monica Bertagnolli to serve as Director of the National Institutes of Health (NIH) this week. Dr. Bertagnolli is a cancer surgeon and researcher. If confirmed, she would be only the second woman to lead the NIH as permanent director. Prior to starting as NCI’s first female director last year, Bertagnolli worked as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Brigham and Women’s Hospital in Boston. She has led NCI since October 2022 while undergoing her own treatment for early-stage breast cancer diagnosed in November.

 

E&C Republicans Probe NIH Leadership Vacancies, EPA Regulation of HFCs

Republican leadership of the House Energy and Commerce Committee have launched an investigation into leadership vacancies at the National Institutes of Health (NIH). The probe, announced by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Chair Morgan Griffith (R-Va.), focuses on the current lack of directors at the National Institute of Allergy and Infectious Diseases and the Fogarty International Center. The lawmakers request that U.S. Department of Health and Human Services Secretary Xavier Becerra respond to questions regarding his involvement in the appointment and reappointment of vacant director positions. They argue that his involvement is necessary to comply with the Appointments Clause of the Constitution, but that information provided by the NIH in response to questions from the committee last year indicate that the NIH Director has been the individual solely responsible for making appointments or reappointments.

Chair Rodgers, alongside Health Subcommittee Chair Guthrie and Environment, Manufacturing, & Critical Materials Subcommittee Chair Bill Johnson (R-Ohio), have also sent a letter to the Environmental Protection Agency (EPA) regarding the regulation of the reclaiming and reuse of hydrofluorocarbons (HFCs). The lawmakers express concern that the agency’s delay of reclaim and reuse provisions will negatively impact the availability and affordability of meter dose inhalers (MDIs). “We are worried that forcing albuterol MDI manufacturers to rely upon constrained and increasingly expensive options to satisfy the market’s needs jeopardizes the supply of essential public health devices and endangers drug access, availability, and affordability for Americans,” the letter states.

 

Sen. Patty Murray Casts 10,000th Vote

Sen. Patty Murray (D-Wash.) became the first woman in the Senate’s history to cast 10,000 votes last week. The vote came on a proposed amendment to the Fire Grants and Safety Act (S. 870), which would extend federal funding for programs supporting the nation’s local fire departments. The milestone was recognized on the Senate floor and applauded by Democrats and Republicans alike. Only 32 individuals – including Mitch McConnell, Chuck Grassley, and Joe Biden – have cast more than 10,000 votes in the chamber’s history. Murray, who was first elected to the Senate in 1993, was selected as the first woman to serve as Senate president pro tempore earlier this year.

 

VA Delays EHR Modernization Effort Indefinitely

The Department of Veterans Affairs (VA) has decided to further delay the implementation of its electronic health records (EHR) modernization project for an indefinite period of time. While the project was initially slated to be completed over 10 years, the VA had already decided to pause its roll-out to new sites until June. The system upgrade has faced significant issues both in terms of projected costs and patient safety. The VA’s contract with its vendor Oracle Cerner expires in May, and the two parties are currently in negotiations about the next five-year contract period.

 

Medscape Releases 2023 Physician Compensation Report

Anew report from Medscape reveals that the number of physicians who accept Medicare and Medicaid patients is at an all-time low. According to the 2023 Physician Compensation Report, only 65% of physicians surveyed indicated that they would continue treating current Medicare or Medicaid patients and take on new ones. Eight percent stated that they would not take on new Medicare patients, while 5% stated they would not take on new Medicaid patients. Four percent plan to stop treating all or some of their current Medicare patients, while 3% will stop treating all or some of their current Medicaid patients altogether. Approximately 22% of respondents had not decided their plans for accepting Medicare and Medicaid beneficiaries. The report is based on responses from 10,011 physicians across more than 29 specialties collected between October 2022 and January 2023.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; April 25

 

House Energy and Commerce Subcommittee on Health legislative hearing “Lowering Unaffordable Costs: Legislative Solutions to Increase Transparency and Competition in Health Care;” 10:00 a.m.; April 26

 

Senate Budget Committee hearing “Under the Weather: Diagnosing the Health Costs of Climate Change;” 10:00 a.m.; April 26

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies hearing “Provider Relief Fund and Healthcare Workforce Shortages;” 10:00 a.m.; April 26

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Reducing Health Care Costs for Working Americans and Their Families;” 10:15 a.m.; April 26

 

Senate Environment and Public Works Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight hearing to examine impacts of plastic production and disposal on environmental justice communities; 9:30 a.m.; April 27

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Addressing America’s Data Privacy Shortfalls: How a National Standard Fills Gaps to Protect Americans’ Personal Information;” 2:00 p.m.; April 27

 

House Homeland Security Subcommittee on Cybersecurity and Infrastructure Protection hearing “CISA 2025: The State of American Cybersecurity from CISA’s Perspective;” 2:00 p.m.; April 27

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “The Biosafety of Risky Research: Examining if Science is Outpacing Policy and Safety;” 2:30 p.m.; April 27

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Antimicrobial Resistance: Examining an Emerging Public Health Threat;” 9:00 a.m., April 28

 

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m., May 10

 

Recently Introduced Health Legislation

 

S.1165 – A bill to amend title XIX of the Social Security Act to allow States to make medical assistance available to inmates during the 30-day period preceding their release; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Finance

 

S.1166 – A bill to require the Comptroller General of the United States to submit a report on the public health mitigation messaging and guidance of the Centers for Disease Control and Prevention; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.263 1 – To prohibit the Federal Government from imposing any mandate requiring an individual to receive a vaccine that has not been authorized for marketing for at least 10 years, and for other purposes; Sponsor: Santos, George [Rep.-R- NY-3]; Committees: House – Energy and Commerce

 

H.R.2636 – To amend the Public Health Service Act to include neuropathy in the list of conditions covered by the World Trade Center Health Program, and for other purposes; Sponsor: Santos, George [Rep.-R-NY-3]; Committees: House – Energy and Commerce

 

H.R.2639 – To amend title XVIII of the Social Security Act to provide for additional requirements with respect to electrodiagnostic services under the Medicare program; Sponsor: Sessions, Pete [Rep.-R-TX-17]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2642 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants for peer mental health first aid, and for other purposes; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce

 

H.R.2647 – To require the Comptroller General of the United States to submit a report on the public health mitigation messaging and guidance of the Centers for Disease Control and Prevention; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

S.Res.159 – A resolution recognizing the designation of the week of April 11 through April 17, 2023, as the sixth annual “Black Maternal Health Week” to bring national attention to the maternal health crisis in the United States and the importance of reducing maternal mortality and morbidity among Black women and birthing persons; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.162 – A resolution designating the week of April 17 through April 23, 2023, as “National Osteopathic Medicine Week”; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.1172 – A bill to amend title 28, United States Code, to make certain improvements relating to the eligibility of veterans to receive reimbursement for emergency treatment furnished to veterans in non-Department of Veterans Affairs facilities, and for other purposes; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Veterans’ Affairs

 

S.1174 – A bill to amend the Internal Revenue Code of 1986 to increase funding for Social Security and Medicare; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Finance

 

S.1176 – A bill to direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1182 – A bill to amend the Public Health Service Act to increase the transparency and accountability of the drug discount program, and for other purposes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1183 – A bill to prohibit discrimination on the basis of mental or physical disability in cases of organ transplants; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.303 – Recognizing the roles and the contributions of care workers in the United States and expressing support for the designation of April 2023 as “Care Worker Recognition Month”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.2663 – To direct the Secretary of Labor to issue an occupational safety and health standard that requires covered employers within the health care and social service industries to develop and implement a comprehensive workplace violence prevention plan, and for other purposes; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.R.2665 – To amend title XIX of the Social Security Act to delay certain disproportionate share hospital payment reductions under the Medicaid program; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.2666 – To amend title XIX of the Social Security Act to codify value-based purchasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2673 – To amend the Internal Revenue Code of 1986 to restore the deduction for research and experimental expenditures; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Ways and Means

 

H.R.2679 – To amend the Public Health Service Act, the Employee Retirement Income Security Act, and the Internal Revenue Code of 1984 to increase oversight of pharmacy benefits manager services, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.2682 – To allow veterans to use, possess, or transport medical marijuana and to discuss the use of medical marijuana with a physician of the Department of Veterans Affairs as authorized by a State or Indian Tribe, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Judiciary; Veterans’ Affairs

 

H.R.2691 – To promote hospital and insurer price transparency; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.2692 – To amend title XX of the Social Security Act to provide grants and training to support area agencies on aging or other community-based organizations to address social isolation among vulnerable older adults and adults with disabilities; Sponsor: Sánchez, Linda T. [Rep.-D-CA-38]; Committees: House – Ways and Means

 

S.1192 – A bill to amend the Public Health Service Act to provide the Secretary of Health and Human Services with the authority to suspend the right to introduce certain persons or property into the United States in the interest of the public health; Sponsor: Hagerty, Bill [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1198 – A bill to reauthorize funding for programs to prevent and investigate elder abuse, neglect, and exploitation, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

 

S.1204 – A bill to allow veterans to use, possess, or transport medical marijuana and to discuss the use of medical marijuana with a physician of the Department of Veterans Affairs as authorized by a State or Indian Tribe, and for other purposes; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate – Judiciary

 

S.1210 – A bill to designate a laboratory as the National Biodefense Analysis and Countermeasures Center, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Veterans’ Affairs

 

S.1211 – A bill to amend title II of the Social Security Act to credit individuals serving as caregivers of dependent relatives with deemed wages for up to five years of such service; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Finance

 

S.1214 – A bill to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1217 – A bill to prohibit the distribution and receipt of rebates for prescription drugs; Sponsor: Hawley, Josh [Sen.-R- MO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1218 – A bill to require that the retail list price for certain prescription drugs and biological products may not exceed the average retail list price for the drug or biological product among certain nations; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1219 – A bill to amend the Public Health Service Act to provide health equity for people with disabilities; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.309 – Expressing the sense of the House of Representatives that the Food and Drug Administration has the authority to approve drugs for abortion care; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Energy and Commerce

 

H.R.2701 – To provide for individual rights relating to privacy of personal information, to establish privacy and security requirements for covered entities relating to personal information, and to establish an agency to be known as the Digital Privacy Agency to enforce such rights and requirements, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D- CA-16]; Committees: House – Energy and Commerce; Judiciary; House Administration; Science, Space, and Technology

 

H.R.2706 – To prohibit discrimination on the basis of mental or physical disability in cases of organ transplants; Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House – Energy and Commerce

 

H.R.2707 – To mitigate drug shortages and provide incentives for maintaining, expanding, and relocating the manufacturing of active pharmaceutical ingredients, excipients, medical diagnostic devices, pharmaceuticals, and personal protective equipment in the United States, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Ways and Means

 

H.R.2713 – To amend titles XVIII and XIX of the Social Security Act to increase access to services provided by advanced practice registered nurses under the Medicare and Medicaid programs, and for other purposes; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2718 – To reauthorize funding for programs to prevent, investigate, and prosecute elder abuse, neglect, and exploitation, and for other purposes; Sponsor: Neal, Richard E. [Rep.-D-MA-1]; Committees: House – Ways and Means; Energy and Commerce; Education and the Workforce; Judiciary

 

H.R.2730 -To amend the Public Health Service Act to include Middle Easterners and North Africans in the statutory definition of a “racial and ethnic minority group”, and for other purposes; Sponsor: Tlaib, Rashida [Rep.-D-MI-12]; Committees: House – Energy and Commerce

 

S.1229 – A bill to establish a Green New Deal for Health to prepare and empower the health care sector to protect the health and wellbeing of our workers, our communities, and our planet in the face of the climate crisis, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1235 – A bill to establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Illegal Drugs, and to provide community based coalition enhancement grants to mitigate the effects of drug misuse; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1246 – A bill to amend title XVIII of the Social Security Act to strengthen the drug pricing reforms in the Inflation Reduction Act; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

S.1250 – A bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for drugs and biologicals include an appropriate disclosure of pricing information; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Finance

 

H.R.2748 – To amend the Fairness to Contact Lens Consumers Act to modernize verification of contact lens prescriptions, and for other purposes; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce

 

H.R.2761 – To amend the Public Health Service Act to authorize a loan repayment program to encourage specialty medicine physicians to serve in rural communities experiencing a shortage of specialty medicine physicians, and for other purposes; Sponsor: Joyce, John [Rep.-R-PA-13]; Committees: House – Energy and Commerce

 

H.R.2763 – To require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety telecommunicators; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce

 

H.R.2764 – To establish a Green New Deal for Health to prepare and empower the health care sector to protect the health and wellbeing of our workers, our communities, and our planet in the face of the climate crisis, and for other purposes; Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House – Energy and Commerce; Ways and Means; Science, Space, and Technology

 

H.R.2768 – To authorize the Secretary of Veterans Affairs to make grants to State and local entities to carry out peer-to- peer mental health programs; Sponsor: LaLota, Nick [Rep.-R-NY-1]; Committees: House – Veterans’ Affairs

 

H.R.2769 – To amend the Internal Revenue Code of 1986 to allow individuals only enrolled in Medicare Part A to contribute to health savings accounts; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Ways and Means

On April 10, President Biden signed into law H.J. Res. 7, the Pandemic is Over Act, a joint resolution terminating the national emergency related to the COVID-19 pandemic. The Biden administration previously announced its intention to end both the COVID-19 pandemic national emergency and public health emergency (PHE) declarations on May 11, 2023. Congress acted to end the national emergency ahead of this timeline. The House of Representatives adopted H.J.Res.7 at the end of January with 11 Democrats joining House Republicans supporting the measure. The Senate adopted the joint resolution on March 29 by a vote of 68 to 23. President Biden’s signature on H.J. Res. 7 puts an end to the COVID-19 national emergency originally declared on March 13, 2020-which provided a framework for the Secretary of the U.S. Department of Health and Human Services (HHS) to exercise certain emergency authorities with appropriate congressional oversight. According to the Centers for Medicare and Medicaid Services (CMS), the end of the national emergency, “does not impact current operations at HHS, and does not impact the planned May 11 expiration of the federal PHE for COVID-19 or any associated unwinding plans…any existing waivers currently in effect and authorized under the 1135 waiver authorization for the pandemic, would remain in place until the end of the federal PHE for COVID-19.”

 

Democratic Senators Request Continued Coverage of Free At- Home Covid Tests

On April 4, Senators Bob Casey (D-Pa.), Chairman of the Senate Special Committee on Aging, and Ron Wyden (D-Ore.), Chairman of the Senate Finance Committee, led a group of nearly 20 Senators in sending a letter to HHS Secretary Xavier Becerra urging the agency to continue providing Medicare coverage of rapid, at-home COVID-19 tests beyond the termination of the PHE. In the letter, the senators argue for continued Medicare coverage for the tests, stating, “Easy access to testing with quick results has prevented the spread of COVID-19, reduced severe infection, and enabled many Americans to resume normal life… Ending Medicare coverage for at-home COVID-19 tests could undo much of this progress and make it harder for Medicare beneficiaries to obtain accurate and timely information about their health. For example, without coverage under Medicare, many older Americans will not be able to afford to pay out-of-pocket for these critical tests and simply won’t test.” House Energy and Commerce Health Subcommittee Ranking Member Anna Eshoo (D-Ca.) sent a similar letter to the agency in September. The PHE is set to terminate on May 11, at which point access to free COVID-19 tests will end and coverage will vary by health plan.

 

Continuous Enrollment in Medicaid Begins Unwinding

Astatutory provision included in the Families First Coronavirus Response Act (FFCRA) required states to allow continuous enrollment in Medicaid, regardless of eligibility, through the end of the COVID-19 PHE in exchange for increased federal funding. Congress separated the provision from the PHE in the Consolidated Appropriations Act, 2023 and established a clear end date of April 1 for the provision. In January, CMS published an Informational Bulletin outlining timelines for states to unwind the requirement and submit a renewal redistribution plan. The Biden Administration estimates that upwards of 15 million individuals may lose Medicaid coverage as a result. Several states, including Arizona, Arkansas, Idaho, New Hampshire, and South Dakota have already started the disenrollment process.

 

HHS Announces National Cancer Plan to Advance Cancer Moonshot

On April 3, HHS announced the creation of a National Cancer Plan to advance the President and First Lady’s Cancer Moonshot vision of cutting cancer mortality by at least half within 25 years and improving quality of life for those impacted by cancer. Developed by the National Institutes of Health’s National Cancer Institute (NCI) in collaboration with the cancer community, the plan provides a framework for the federal government and all of society to collaborate to end cancer. The plan establishes eight goals and corresponding strategies, to: prevent cancer; detect cancers early; develop effective treatments; eliminate inequities; deliver optimal care; engage every person; maximize data utility; and optimize the workforce. The President’s Fiscal Year (FY) 2024 proposed budget requests Congress provide a $503 million increase from FY2023 levels for NCI and additional funding for the Cancer Moonshot initiative.

 

Nursing Workforce Survey Released

The National Council of State Boards of Nursing released a new survey titled “Examining the Impact of the COVID-19 Pandemic on Burnout & Stress Among U.S. Nurses.” The survey reveals that during the COVID-19 pandemic approximately 100,000 registered nurses retired or resigned due to stress and burnout. One-fifth of registered nurses are estimated to leave the nursing workforce by 2027. Reasons cited include increased workload, feeling emotionally drained and fatigued, among others. The survey also looked at the continued downward trend of the number of licensed practical/ vocational nurses.

 

Republican Health Committee Leaders Raise Concerns with Biden Administration Drug Price Setting Guidance

On April 12, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure voicing concerns with Inflation Reduction Act implementation guidance related to the drug price-setting provisions in the law. The letter emphasizes concerns, stating “This guidance exacerbates the law’s statutory flaws and compounds the profound uncertainty and risk posed by the legislation’s sweeping drug price controls. We encourage you to reconsider the many components of the initial guidance that will otherwise stifle medical innovation and quality improvement, discourage proven public- private partnerships, undermine American intellectual property (IP) protections, and provide unacceptable conditions for public feedback. If finalized as proposed, these provisions will serve to make bad policy worse, harming patients, caregivers, and health care providers across the United States for generations to come.” HHS published the initial program guidance on March 15 and provided a limited commenting opportunity that closed on April 14. By September 1, the agency will announce the first set of Medicare Part D drugs subject to price negotiation under the program. In 2026, a maximum of ten high-expenditure Part D drugs will have maximum fair prices set under the program.

 

Senate HELP Committee Drug Pricing Markup Postponed

The Senate Health, Education, Labor and Pensions (HELP) Committee has postponed an anticipated markup of bipartisan drug pricing legislation. The new legislation has yet to be made public but is expected to focus on policies related to pharmacy benefit managers (PBMs) and generics, potentially drawing from previous proposals on these topics. Staff indicated that the committee is waiting for a significant amount of technical assistance before proceeding. Earlier this year, the committee announced a series of planned, closed-door roundtables to hear from experts on several topics. The committee has heard and will continue to hear from a range of industry experts, including innovative drug makers, the generics and biosimilars industries, and PBMs.

 

Democratic Health Committee Leaders Seek Information from Health Plans on Preventive Care Coverage After Court Ruling

On March 30, a federal judge’s ruling in Texas struck down an Affordable Care Act (ACA) requirement for health plans to fully cover certain preventative healthcare services recommended by the U.S. Preventive Services Task Force without cost-sharing. In response, five Democratic health committee leaders sent letters to 12 health plans seeking information on future coverage plans for preventive services, such as mammograms and screenings for cervical cancer, colorectal cancer, osteoporosis, hepatitis B virus, HIV, and lung cancer. In the letter, the committee leaders state, “We are very concerned that the decision will unnecessarily cause confusion, force consumers to pay out-of-pocket, and result in patients foregoing preventive services screenings and treatment altogether. There is evidence that even modest cost-sharing deters patients from accessing care and exposure to cost-sharing reduces the use of preventive care. We are very concerned that the decision will roll back the significant health care gains that have been made under the ACA and will worsen racial and ethnic inequities.” The letter was signed by House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), House Ways and Means Committee Ranking Member Richard Neal (D-Mass.) House Education and the Workforce Ranking Member Robert “Bobby” Scott (D-Va.), Senate Finance Committee Chairman Ron Wyden (D-OR), and Senate HELP Committee Chairman Bernie Sanders (I-Vt.). On April 13, U.S. Department of Justice announced it was seeking a stay in Braidwood v. Becerra. HHS Secretary stated that “President Biden, and this entire Administration, will do everything possible to protect and defend Americans’ right to the health care they need and deserve.”

 

HHS Proposes New Rule on Transparency for Artificial Intelligence

On April 11, the HHS Office of the National Coordinator (ONC) issued a notice of proposed rulemaking (HT1-1 proposed rule) to alter the ONC Health IT Certification Program. The HTI-1 proposed rule would implement provisions of the 21st Century Cures Act and according to the agency, seeks to “advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information.” As part of the rulemaking, those creating Artificial Intelligence (AI) used in health care will be required to publicly disclose information on data used to inform algorithms to receive HHS’ certification. Currently, certification is voluntary except for certain technologies. The Food and Drug Administration (FDA) has also taken steps to regulate AI. Earlier in April, FDA issued draft guidance related to increasing patient access to AI/machine learning-enabled devises to advance public health. The HTI-1 proposed rule will be formally published on April 18 and public comments will be accepted through June 20, 2023.

 

POLICY BRIEFINGS

 

States, Federal Government Consider Scope of Practice Legislation

Some states and the federal government are considering legislation to expand scope of practice to meet demand for future healthcare needs amid a growing workforce shortage in the industry. The Association of American Medical Colleges estimates that the United States could face a shortage of up to nearly 140,000 physicians by 2033. To increase patient access to care and address this shortage, a record number of bills, almost 200, have been filed in states to allow non- physician practitioners to prescribe and administer certain medications and vaccines. Some states, including Colorado, Connecticut, Florida, Iowa, and Montana, are considering legislation that would change the supervision relationship between physician assistants and physicians. Temporary flexibilities offered during the COVID-19 public health emergency opened the door to allowing certain clinicians to practice medicine beyond their scope, e.g., pharmacists were given the authority to administer the COVID-19 vaccines. While many physician groups recognize policies are needed to increase patient access to care, concerns have been voiced with potential changes to scope of practice laws due to the impact on patient safety, as non-physician providers lack commensurate training and experience.

The administration and Congress are also beginning to consider policies to address healthcare workforce shortages. During a hearing last month, Senate HELP Committee Ranking Member Bill Cassidy, M.D. (R-La.) raised the issue by stating, “Scope of practice has traditionally been state-based, and I personally think it should continue to be state-based… But as a rule, I am very much for everybody practicing to the upper limit of their license.” Members of the Senate HELP Committee are expected to introduce legislation to address healthcare workforce shortages later this year. The Department of Veterans Affairs (VA) is also in the process of issuing and formalizing scope of practice standards across VA clinics, expected through the beginning of 2024.

 

Senators Return to Capitol Hill, but Senate Majority Continues to Lack Full Operating Capacity

Members of Congress are returning to Capitol Hill after a two-week recess. Senate Republican Leader Mitch McConnell (R-Ky.) plans to return on Monday, after suffering a concussion and hospitalization from a fall last month. Senator John Fetterman (D-Pa.) also indicated he would be back after a six-week hospitalization for depression. Senator Dianne Feinstein (D-Calif.) announced her return to Washington would be delayed due to ongoing health complications. She has been out for nearly two months, complicating the ability of the Senate Democratic Majority to advance President Biden’s judicial nominees. On April 12, Representative Ro Khanna (D-Calif.) called for the Senator’s resignation, stating “We need to put the country ahead of personal loyalty. While she has had a lifetime of public service, it is obvious she can no longer fulfill her duties.” Representative Dean Philips (D-Minn.) agreed, stating “it’s now a dereliction of duty [for her] to remain in the Senate.” In response and citing that her “absence could delay the important work of the Judiciary Committee,” Senator Feinstein called on the chamber to appoint a temporary replacement on the Judiciary Committee until she’s able to resume her committee work. Senator Feinstein previously announced that she will not run for reelection in 2024.

 

EPA Proposes to Reduce Exposure to Gas Used to Sterilize Medical Devices

On April 11, the Environmental Protection Agency (EPA) issued new proposals to reduce exposure to Ethylene Oxide (EtO) used to sterilize medical devices. According to the agency, long-term exposure to EtO pollution, for those working in facilities and for those in nearby communities, increases the risk of certain cancers. In the first proposal, EPA is seeking to cut EtO emissions by 80 percent per year across 86 commercial sterilizers nationwide-harmonizing emissions levels in line with EPA’s Clean Air Act benchmark for elevated cancer risk. The second proposal, with authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), seeks to protect facility workers by limiting the amount of EtO that can be applied to sterilize medical devices. According to the FDA, about 50 percent of medical devices are sterilized with EtO. In 2019, an FDA Advisory Committee met to discuss EtO use-experts agreed that no other medical device sterilant alternatives exist. In conjunction with the EPA proposals, the FDA announced the voluntary Radiation Sterilization Master File Pilot Program-open to nine eligible participants to help the industry advance alternatives for EtO sterilization of medical devices. The medtech and medical device industry voiced concerns with the announcement. Medical Device Manufacturers Association (MDMA) CEO Mark Leahey stated, “Reducing an already stretched supply chain would be catastrophic for patient care, and our sincere hope is that the EPA and the Administration will listen to hospitals, FDA and others to ensure that nothing is done that would compromise patient access to safe and effective medical technologies.” The public comment period is open for sixty days, with a final rule expected in 2024.

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Origins of COVID-19, Part 2: China and the Available Intelligence;” 9:30 a.m.; April 18

 

House Appropriations Subcommittee on State, Foreign Operations, and Related Programs hearing “Fiscal Year 2024 Budget Request for the United States Agency for International Development (USAID);” 10:00 a.m.; April 18

 

House Veterans’ Affairs Subcommittee on Health markup, “Pending Legislation”; 10:00 a.m.; April 18

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Insights from the HHS Inspector General on Oversight of Unaccompanied Minors, Grant Management, and CMS;” 10:30 a.m.; April 18

 

House Veterans’ Affairs Subcommittee on Health hearing, “Combatting a Crisis: Providing Veterans Access to Life-saving Substance Abuse Disorder Treatment;” 12:00 p.m.; April 18

 

Senate Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies Hearing, “A Review of the President’s Fiscal Year 2024 Funding Request for the National Aeronautics and Space Administration and for the National Science Foundation;” 2:30 p.m.; April 18

 

Senate Environment and Public Works Subcommittee on Clean Air, Climate, and Nuclear Safety hearing “Cleaner Vehicles: Good for Consumers and Public Health”; 2:30 p.m.; April 18

 

Senate Armed Services Subcommittee on Cybersecurity hearing to receive testimony on artificial intelligence and machine learning applications to enable cybersecurity; 9:30 a.m.; April 19

 

House Veterans’ Affairs Subcommittee on Oversight and Investigations hearing on H.R. 592, Department of Veterans Affairs Electronic Health Record Modernization Improvement Act; H.R. 608, To terminate the Electronic Health Record Modernization Program of the Department of Veterans Affairs; H.R. 1658, Manage VA Act; H.R. 1659, Department of Veterans Affairs IT Modernization Improvement Act; and H.R. 2499, VA Supply Chain Management System Authorization Act; 9:30 a.m.; April 19

 

House Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies hearing “Fiscal Year 2024 Request for the National Science Foundation;” 9:30 a.m.; April 19

 

House Committee on Energy and Commerce Health Subcommittee hearing “Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care;” including H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act and H.R. 2411, the National Nursing Workforce Center Act; 10:00 a.m.; April 19

 

Senate Foreign Relations Committee hearing “PEPFAR at 20: Achieving and Sustaining Epidemic Control;” 10:00 a.m.; April 19

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies hearing “Fiscal Year 2024 Request for the Centers for Disease Control and Prevention, Administration for Strategic Preparedness and Response, and National Institute of Health;” 10:00 a.m.; April 19

 

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Office of Inspector General Reports to Congress on Investigations of SBA Programs;” 10:00 a.m.; April 19

 

Senate Agriculture Subcommittee on Food and Nutrition, Specialty Crops, Organics, and Research hearing “SNAP and Other Nutrition Assistance in the Farm Bill;” 12 p.m.; April 19

 

Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies hearing “A Review of the President’s Fiscal Year 2024 Budget Request for the Food and Drug Administration;” 2:30 p.m.; April 19

 

Senate Environment and Public Works Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight hearing to examine impacts of plastic production and disposal on environmental justice communities; 9:30 a.m.; April 27

 

Recently Introduced Health Legislation

H.R.2630 – To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Education and the Workforce

 

H.R.2615 – To amend the Internal Revenue Code of 1986 to exclude PFAS remediation reimbursements from gross income; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Ways and Means

 

H.R.2600 -To amend title XIX of the Social Security Act to ensure the equitable treatment of political subdivisions contributing to State expenditures under the Medicaid program; Sponsor: Langworthy, Nicholas A. [Rep.-R-NY-23]; Committees: House – Energy and Commerce

 

H.R.2592 – To allow States and local educational agencies to use any remaining COVID-19 elementary and secondary school emergency relief funds for school security measures; Sponsor: Garcia, Mike [Rep.-R-CA-27]; Committees: House – Education and the Workforce

 

H.R.2584 – To protect hospital personnel from violence, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Judiciary

 

H.R.2583 – To amend title XVIII of the Social Security Act to expand and expedite access to cardiac rehabilitation programs and pulmonary rehabilitation programs under the Medicare program, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2577 – To amend the Homeland Security Act of 2002 to establish the Law Enforcement Mental Health and Wellness Program, and for other purposes; Sponsor: Thompson, Bennie G. [Rep.-D-MS-2]; Committees: House – Homeland Security

 

H.R.2574 – To require the Secretary of Labor to revise the Standard Occupational Classification System to accurately count the number of emergency medical services practitioners in the United States; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Education and the Workforce

 

H.R.2573 – To express the Sense of Congress with respect to Federal preemption of State restrictions on dispensing medication abortion, and for other purposes; Sponsor: Ryan, Patrick [Rep.-D-NY-18]; Committees: House – Energy and Commerce

 

H.R.2570 – To require more accurate reporting of abortion drug prescribing and related adverse events, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Energy and Commerce

 

H.R.2569 – To amend the Public Health Service Act to reauthorize the program of payments to teaching health centers that operate graduate medical education programs; Sponsor: Pallone, Frank, Jr. [Rep.-D-NJ-6]; Committees: House – Energy and Commerce

 

H.R.2562 – To direct the Administrator of the Federal Aviation Administration to enter into appropriate arrangements with the National Academies of Sciences, Engineering, and Medicine to provide for a report on the health impacts of air traffic noise and pollution, and for other purposes; Sponsor: Lynch, Stephen F. [Rep.-D-MA-8]; Committees: House – Transportation and Infrastructure

 

H.R.2559 – To extend funding for community health centers and the National Health Service Corps, and for other purposes; Sponsor: Joyce, John [Rep.-R-PA-13]; Committees: House – Energy and Commerce

 

H.R.2550 – To extend funding for Special Diabetes Programs for Type I diabetes. Sponsor: DeGette, Diana [Rep.-D- CO-1]; Committees: House – Energy and Commerce.

 

H.R.2548 -To require the Secretary of Health and Human Services to collect and disseminate information on concussion and traumatic brain injury among public safety officers; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

H.R.2547 – To amend title III of the Public Health Service Act to extend funding for special diabetes programs for Indians; Sponsor: Cole, Tom [Rep.-R-OK-4]; Committees: House – Energy and Commerce

 

H.R.2544 – To improve the Organ Procurement and Transplantation Network, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.2543 -To improve the provision of health care by the Department of Veterans Affairs, and for other purposes; Sponsor: Wittman, Robert J. [Rep.-R-VA-1]; Committees: House – Veterans’ Affairs

 

H.R.2541 -To prioritize the hiring and training of veterans and retired law enforcement officers as school resource officers, and for other purposes; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Judiciary; Veterans’ Affairs; Education and the Workforce

 

H.R.2535 -To elevate the position of Director of the Indian Health Service within the Department of Health and Human Services to Assistant Secretary for Indian Health, and for other purposes; Sponsor: Stanton, Greg [Rep.-D-AZ-4]; Committees: House – Natural Resources; Energy and Commerce

 

H.R.2534- To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes; Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2530 -To amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2528-To amend the Family and Medical Leave Act of 1993 and title 5, United States Code, to permit leave to care for an adult child, grandchild, or grandparent who has a serious health condition, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; House – Education and the Workforce; Oversight and Accountability; House Administration

 

H.R.2526 -To amend title 38, United States Code, to clarify that caregivers for veterans with serious illnesses are eligible for assistance and support services provided by the Secretary of Veterans Affairs, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Veterans’ Affairs

 

H.R.2503-To modify the project for Central and Southern Florida to include public health considerations, and for other purposes; Sponsor: Mast, Brian J. [Rep.-R-FL-21]; Committees: House – Transportation and Infrastructure

 

H.R.2502 – To repeal the Gun-Free School Zones Act of 1990 and amendments to that Act. Sponsor: Massie, Thomas [Rep.-R-KY-4]; Committees: House – Judiciary

 

H.R.2500 – To amend the Federal Food, Drug, and Cosmetic Act to expand certain authorities with respect to the recall of controlled substances to apply with respect to all drugs, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House – Energy and Commerce

 

H.R. 2499-To authorize the Secretary of Veterans Affairs to carry out an information technology system and prioritize certain requirements to manage supply chains for medical facilities of the Department of Veterans Affairs; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Veterans’ Affairs

 

H.R. 2492-To restrict the availability of Federal funds to organizations associated with the abortion industry; Sponsor: Foxx, Virginia [Rep.-R-NC-5]; House – Foreign Affairs

 

H.R. 2491-To establish a grant program to improve school security, including by training and hiring veterans and former law enforcement officers as school safety officers, and for other purposes; Sponsor: Fleischmann, Charles J. “Chuck” [Rep.- R-TN-3]; Committees: House – Education and the Workforce; Judiciary

 

H.R. 2483-To amend the Elementary and Secondary Education Act of 1965 to strengthen school security; Sponsor: Carter, John R. [Rep.-R-TX-31]; House – Education and the Workforce

 

H.R.2482-To require the Secretary of Defense to conduct a study on the accessibility of mental health care providers and services for members of the Armed Forces serving on active duty, and for other purposes; Sponsor: Buchanan, Vern [Rep.- R-FL-16]; House – Armed Services

 

H.R.2480 -To direct the Secretary of Health and Human Services to issue guidance on coverage under the Medicaid program under title XIX of the Social Security Act of certain pelvic health services furnished during the postpartum period, and for other purposes; Sponsor: Bacon, Don [Rep.-R-NE-2]; Committees: House – Energy and Commerce

 

H.R.2479 – To provide for safe schools and safe communities; Sponsor: Weber, Randy K., Sr. [Rep.-R-TX-14]; Committees: House – Education and the Workforce; Homeland Security; Judiciary; Energy and Commerce; Appropriations

 

H.R.2478 -To amend the Internal Revenue Code of 1986 to provide for an exclusion from gross income for compensation of certain school resource officers, and for other purposes; Sponsor: Weber, Randy K., Sr. [Rep.-R-TX-14]; Committees: House – Ways and Means

 

H.R.2477 – To amend the Gun-Free School Zones Act of 1990 to permit qualified law enforcement officers, qualified retired law enforcement officers, and persons not prohibited by State law from carrying a concealed firearm to carry a firearm, and to discharge a firearm in defense of self or others, in a school zone; Sponsor: Weber, Randy K., Sr. [Rep.-R- TX-14]; Committees: House – Judiciary

 

H.R.2476 -To keep schools safe using unobligated Federal funds available to the Secretary of Education to respond to the coronavirus; Sponsor: Weber, Randy K., Sr. [Rep.-R-TX-14]; Committees: House – Education and the Workforce

 

H.R.2475-To direct the Director of the National Science Foundation to award grants for, and support research on, the development of makerspaces, and for other purposes; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House – Science, Space, and Technology

 

H.R.2474 -To amend title XVIII of the Social Security Act to provide for an update to a single conversion factor under the Medicare physician fee schedule that is based on the Medicare economic index; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2473 -To amend title XVIII of the Social Security Act to distribute additional information to Medicare beneficiaries to prevent health care fraud, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2472 -To direct the Secretary of Veterans Affairs to take actions necessary to ensure that certain individuals may update the burn pit registry with a registered individual’s cause of death, and for other purposes; Sponsor: Ruiz, Raul [Rep.- D-CA-25]; Committees: House – Veterans’ Affairs

 

H.R.2471 -To prohibit the unauthorized possession of a firearm at a Federal election site; Sponsor: Ruiz, Raul [Rep.-D- CA-25]; Committees: House – Judiciary

 

H.R.2469 -To direct the Secretary of Defense to establish an outreach program to inform members of the Armed Forces, assigned to work near burn pits, of the risks of toxic exposure, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D- CA-25]; Committees: House – Armed Services

 

H.R. 2457- To establish a National Science Foundation grant program to provide opportunities for and strengthen research capacity at institutions of higher education to stimulate sustainable improvement in existing research and development at such institutions, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Science, Space, and Technology

 

H.Res.281 – Supporting the goals and ideals of “National Youth HIV/AIDS Awareness Day”; Sponsor: Lee, Barbara [Rep.- D-CA-12]; Committees: House – Energy and Commerce

 

H.Res.276 -Expressing support for the designation of April 5, 2023, as “Barth Syndrome Awareness Day”; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

Congress will return to session on Monday, April 17. The House of Representatives is in a District Work Period through Sunday, April 16, 2023, but will convene for a pro forma session on Monday, April 3. During the recess, the Senate will convene on Mondays and Thursdays for pro forma sessions only, with no business being conducted.

 

President to Sign Legislation Ending COVID-19 National Emergency

President Joe Biden plans to sign into law legislation passed by the Senate last week (H.J.Res. 7) that would terminate the COVID-19 national emergency early, despite White House opposition to the measure. The bill – which passed the House of Representatives on February 1 and cleared the Senate in a 68-23 vote on Wednesday – would immediately end the national emergency upon being signed by the President. Both the COVID-19 public health emergency (PHE) declared in January 2020, and the national emergency declared in March 2020 are set to expire on May 11 under the wind-down plan announced by the administration in January. While May 11 remains the expiration date of the COVID-19 PHE, the resolution will impact federal healthcare programs. Blanket waivers issued by the U.S. Department of Health and Human Services – including certain requirements for Medicare provider enrollment, requirements for in-person meetings between providers and patients, and requirements for out-of-state Medicare and Medicaid providers to be licensed in the state where they are providing services – were issued under the national emergency declaration. Some additional flexibilities issued to states and territories for the administration of their Medicaid and CHIP programs, like those permitting the provision of services in alternative settings and those to ease provider enrollment in the programs, are also tied to the national emergency declaration. Although the administration “strongly opposes” H.J.Res. 7, it “will continue working with agencies to wind down the national emergency with as much notice as possible to Americans who could potentially be impacted,” a White House official stated to The Hill. More information on the emergency declarations can be found in Hart Health Strategies Inc.’s primer on Public Health Emergencies and Major Disaster Declarations.

 

Judge Strikes ACA’s Preventive Services, HIV Treatment Coverage Mandates

U.S. District Court Judge Reed O’Connor has struck down the Affordable Care Act’s (ACA) preventive services coverage requirement. The requirement mandates that insurers and employers cover more than 100 preventive health services, e.g., mammograms and colonoscopies, recommended by the U.S. Preventive Services Task Force (USPSTF) for free. The judge for the Northern District of Texas ruled that the USPSTF is unconstitutional because its members wield power that resembles legislative authority without being appointed by the President and confirmed by the Senate. He also invalidated the law’s coverage mandate for HIV pre-exposure prophylactic (PrEP) drugs on the grounds that it violates the religious freedom of a Christian-owned company. The Biden administration is expected to appeal the decision.

 

Medicare Trustees Recommend Congress Address Projected Shortfalls

On Friday, the Medicare Boards of Trustees released their annual report on the Federal Hospital Insurance (Medicare Part A) and Federal Supplementary Medical Insurance (Medicare Part B) Trust Funds. The Trustees have again determined that the Part A trust fund “is not adequately financed over the next 10 years.” The depletion date is now 2031, 3 years later than last year’s projection. Expenditures exceeded income in 2022 and deficits are projected beginning in 2025. The Part A trust fund has failed to meet the Trustees’ formal short-range financial adequacy test since 2003. The Part B trust fund draws from general revenue and therefore is expected to be adequately financed through beneficiary premiums and federal funds. Upon the release of the report, CMS Administrator Chiquita Brooks-LaSure stated that “Everyone in the Biden-Harris Administration is committed to protecting Medicare, and we look forward to working with Congress to strengthen this vital program serving over 65 million Americans.”

 

E&C GOP Leaders Contact FDA on Drug Shortages, Gain-of-Function Research

House Energy and Commerce Committee Republican leadership have sent a letter to the Biden administration requesting information related to drug shortages. The lawmakers assert that the Food and Drug Administration (FDA) may not effectively be using its existing authorities to prevent or reduce ongoing drug shortages and request details about the scarcity of drugs to treat asthma, cancer, tuberculosis, bacterial infection, and headaches, pain, and fever – specifically seeking information on shortages of albuterol, Pluvicto, cisplatin, fluorouracil, methotrexate, Bacillus Calmette- Guerin (BCG), amoxicillin, acetaminophen, and ibuprofen. They point out that the agency has not yet released any information on the reports required by the Coronavirus Aid, Relief, and Economic Security Act from industry on listed drugs manufactured, prepared, or processed for commercial distribution and where active pharmaceutical ingredients and finished dosage forms were made. The letter to FDA Commissioner Robert Califf was signed by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.). The lawmakers request a response by April 13.

Rodgers, Guthrie, and Griffith also sent a separate letter to Commissioner Califf following up on prior questions posed to the agency about the FDA’s funding of gain-of-function research last week. While FDA staff have acknowledged that some agency research studies “involve virus manipulation, passaging of a virus, genetically modified animals, or making any mutations to a virus,” the latest letter requests additional details to put these studies in context and enable an assessment of the adequacy of FDA’s oversight of potential risks in such experiments. The lawmakers request a response to this letter by April 10.

 

Eshoo, Guthrie Call on FDA to Address Backlog of Cell and Gene Therapy Applications

House Energy and Commerce Health Subcommittee leadership Chairman Brett Guthrie (R-Ky.) and Ranking Member Anna Eshoo (D-Calif.) have sent a letter to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research Director Peter Marks expressing concerns about the increasing number of clinical holds on biologics license applications which delay a proposed clinical investigation or suspend an ongoing investigation for such products. They request details about the agency’s process for addressing these holds and “encourage the FDA to use its regulatory discretion where necessary to make these innovative products available to patients in need, particularly those with ultra-rare or fatal diseases or for whom there are limited or no treatment options. The full letter can be found here and requests a response no later than April 14.

 

Comer Requests Briefing on Regulation of Tobacco, Nicotine

House Oversight and Accountability Chairman James Comer (R-Ky.) has sent a letter to the Food and Drug Administration requesting information and a staff briefing on the Center for Tobacco Product’s (CTP) tobacco and nicotine regulatory programs. Comer references a recent evaluation by the Reagan-Udall Foundation, which found that CTP has not clearly detailed “the most basic elements” of such programs, resulting in “confusion, inefficiency, litigation, and suspicions of political interference.” The letter expresses concerns that the Center has allowed unsafe and unregulated products to proliferate on the market and requests a response from the agency no later than April 11.

 

Duckworth Urges FTC Intervention on Mifepristone Distribution

Sen. Tammy Duckworth (D-Ill.) is urging the Federal Trade Commission (FTC) to investigate AmerisourceBergen following reports that the company plans to limit the sale of mifepristone. AmerisourceBergen is the sole wholesale distributor of the brand-name version of the abortion medication. “The bottom line is that based on existing information, data and evidence, one cannot dismiss the possibility that AmerisourceBergen may be using broader political disagreements and active legal debates as pretextual cover and justification for engaging in anticompetitive, unfair, and deceptive practices that are primarily concerned with maximizing profit margins by reducing consumer choice and restricting trade with an entire industry of retail pharmacies,” Duckworth argues.

 

POLICY BRIEFINGS

 

Fetterman, Feinstein Expected to Return Following April Recess

Sen. John Fetterman (D-Pa.) plans to return to the Senate the week of April 17, according to sources close to the lawmaker. Fetterman announced in mid-February that he had checked himself into inpatient treatment at Walter Reed Medical Center and was seeking treatment for clinical depression on the recommendation of Congress’ attending physician. According to the American Stroke Association, depression is common among stroke survivors. Fetterman suffered a stroke on the campaign trail last year. Sen. Dianne Feinstein (D-Calif.) has also been absent from the chamber since being hospitalized following a shingles diagnosis over the February recess. Sen. Tim Kaine (D-Va.) stated that he expects her to return to the Senate in the days following the upcoming two-week congressional recess as well.

 

WHO Revises COVID Vaccine Recommendations

The World Health Organization (WHO) has revised its COVID-19 vaccine recommendations in response to the current phase of the disease and global immunity levels. WHO suggests that high-risk populations – older adults and people with significant risk factors – receive an additional dose of the vaccine either six or 12 months after their latest dose, based on factors like age and any immunocompromising conditions. The global health agency advises that countries consider factors like disease burden before recommending the vaccination of healthy children and adolescents.

 

Recently Introduced Health Legislation

 

H.R.1800 – To prohibit Federal spending on funding research in China, and for other purposes. Sponsor: Williams, Brandon [Rep.-R-NY-22]; Committees: House – Science, Space, and Technology

 

H.R.1795 – To amend the Internal Revenue Code of 1986 to allow qualified distributions from health savings accounts for certain home care expenses; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committee: House – Ways and Means

 

H.R.1790 – To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committee: House – Energy and Commerce

 

H.R.1781 – To amend the Public Health Service Act with respect to the designation of general surgery shortage areas, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committee: House – Energy and Commerce

 

H.R.1780 – To facilitate the development of treatments for cancer, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1776 -End Tuberculosis Now Act of 2023- To prevent, treat, and cure tuberculosis globally; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committee: House – Foreign Affairs

 

H.R.1774 – To amend title 38, United States Code, to reimburse veterans for the cost of emergency medical transportation to a Federal facility, and for other purposes; Sponsor: Alford, Mark [Rep.-R-MO-4]; Committees: House – Veterans’ Affairs

 

S.983 – A bill to permit the Attorney General to award grants for accurate date on opioid-related overdoses, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Judiciary

 

S.986 – A bill to increase the criminal penalty for mail fraud involving misrepresentation of the country of origin, to terminate the authority to exclude countries from the requirement to transmit advance electronic information for 100 percent of mail shipments under the STOP Act of 2018, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

H.Res.259 – Promoting youth mental health and well-being in a changing climate; Sponsor: Thompson, Mike [Rep.-D- CA-4]; Committees: House – Energy and Commerce

 

H.R.1805 – To mitigate the effects of the COVID-19 pandemic on incentives under the Federal Food, Drug, and Cosmetic for the development of orphan drugs, and for other purposes; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Energy and Commerce

 

S.993 – A bill to prohibit certain uses of xylazine, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Judiciary

 

S.996 – A bill to amend title XIX of the Social Security Act to establish a demonstration project to improve outpatient clinical care for individuals with sickle cell disease; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1000 – A bill to amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance

 

S.1001 – A bill to amend the Internal Revenue Code of 1986 to permanently extend the exemption for telehealth services from certain high deductible health plan rules; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Finance

 

S.1002 – A bill to amend title XVIII of the Social Security Act to improve risk adjustment under Medicare Advantage; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

H.R.1825 – To clarify that the Federal Right to Try law applies to schedule I substances for which a phase I clinical trial has been completed and to provide access for eligible patients to such substances pursuant to the Federal Right to Try law; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1826 – To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide coverage for prostate cancer screenings without the imposition of cost-sharing requirements, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.1827 – To prohibit the National Institutes of Health from conducting or supporting certain gain-of-function research, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.1835 – To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1839 – To prohibit certain uses of xylazine, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1843 – To amend the Internal Revenue Code of 1986 to permanently extend the exemption for telehealth services from certain high deductible health plan rules; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means

 

S.1024 – A bill to authorize the Secretary of Health and Human Services to award grants to eligible entities to develop and implement a comprehensive program to promote student access to defibrillation in public elementary schools and secondary schools; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1026 – A bill to authorize the appropriation of funds to the Centers for Disease Control and Prevention for conducting or supporting research on firearms safety or gun violence prevention; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1028 – A bill to amend title 38, United States Code, to expand health care and benefits from the Department of Veterans Affairs for military sexual trauma, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.1031 – A bill to ensure affordable abortion coverage and care for every person, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1037 – A bill to prohibit the Secretary of Veterans Affairs from carrying out certain activities under the Electronic Health Record Modernization Program until certification of system stability improvements; Sponsor: Moran, Jerry [Sen.- R-KS]; Committees: Senate – Veterans’ Affairs

 

S.1038 – A bill to amend title XIX of the Social Security Act to improve transparency and prevent the use of abusive spread pricing and related practices in the Medicaid program; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Finance

 

S.1040 – A bill to amend title 38, United States Code, to prohibit smoking on the premises of any facility of the Veterans Health Administration, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Veterans’ Affairs

 

S.1057 – A bill to require responsiveness testing of Defense Logistics Agency pharmaceutical contracts; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Armed Services

 

S.1063 – A bill to amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

S.1064 – A bill to direct the Secretary of Health and Human Services to carry out a national project to prevent and cure Parkinson’s, to be known as the National Parkinson’s Project, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.- R-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1067 – A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.2392 – To require a seven-day waiting period before the receipt of a firearm; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Judiciary

 

H.R.2391 – To amend title 18, United States Code, to temporarily prohibit the transfer of a firearm to, or the possession of a firearm by, a person convicted of a misdemeanor in which a firearm was used, carried, or possessed; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Judiciary

 

H.R.2390 – To authorize the appropriation of funds to the Centers for Disease Control and Prevention for conducting or supporting research on firearms safety or gun violence prevention; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Energy and Commerce

 

H.R.2389 – To amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions, and for other purposes; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.2377 – To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2376 – To amend the Indian Health Care Improvement Act and title 5 of the United States Code to facilitate participation in Federal benefits programs, and for other purposes; Sponsor: Grijalva, Raúl M. [Rep.-D-AZ-7]; Committees: House – Oversight and Accountability; Natural Resources; Energy and Commerce

 

H.R.2370 – To authorize the Secretary of Health and Human Services to award grants to eligible entities to develop and implement a comprehensive program to promote student access to defibrillation in public elementary schools and secondary schools; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.2369 – To amend the Federal Food, Drug, and Cosmetic Act with respect to in vitro clinical tests, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2365 – To direct the Secretary of Health and Human Services to carry out a national project to prevent and cure Parkinson’s, to be known as the National Parkinson’s Project, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R- FL-12]; Committees: House – Energy and Commerce

 

H.R.2335 – To provide for a limitation on availability of funds for Bilateral Economic Assistance, Global Health Programs, HIV/AIDS for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Foreign Affairs

 

H.R.2334 – To provide for a limitation on availability of funds for Bilateral Economic Assistance, Global Health Programs for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Foreign Affairs

 

H.R.2297 – To provide for a limitation on availability of funds for Related Agency and Food and Drug Administration, FDA Innovation Account, Cures Act for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2296 – To provide for a limitation on availability of funds for Related Agency and Food and Drug Administration, Buildings and Facilities for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2295 – To provide for a limitation on availability of funds for Related Agency and Food and Drug Administration, Department of Health and Human Services, Food and Drug Administration, for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2104 – To provide for a limitation on availability of funds for District of Columbia, Federal Payment for Testing and Treatment of HIV/AIDS for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Oversight and Accountability

 

H.R.2021 – To provide for a limitation on availability of funds for Department of Health and Human Services, Public Health and Social Services Emergency Fund for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2020 – To provide for a limitation on availability of funds for Department of Health and Human Services, Office for Civil Rights for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5] Committees: House – Energy and Commerce

 

H.R.2019 – To provide for a limitation on availability of funds for Department of Health and Human Services, Office of the Inspector General for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce; Natural Resources; Education and the Workforce; Ways and Means

 

H.R.2018 – To provide for a limitation on availability of funds for Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2017 – To provide for a limitation on availability of funds for Department of Health and Human Services, Office of the Secretary, Office of Medicare Hearings and Appeals for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.2016 – To provide for a limitation on availability of funds for Department of Health and Human Services, Office of the Secretary, General Departmental Maintenance for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce; Natural Resources; Education and the Workforce; Ways and Means

 

H.R.2015 – To provide for a limitation on availability of funds for Department of Health and Human Services, Administration for Community Living, Aging and Disability Services Programs for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means; House Administration

 

H.R.2006 – To provide for a limitation on availability of funds for Department of Health and Human Services, The Agency for Heathcare Research and Quality for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2005 – To provide for a limitation on availability of funds for Department of Health and Human Services, Substance Abuse and Mental Health Services Administration Health Surveillance and Program Support for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2004 – To provide for a limitation on availability of funds for Department of Health and Human Services, Substance Abuse and Mental Health Services Administration Substance Abuse Prevention for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2003 – To provide for a limitation on availability of funds for Department of Health and Human Services, Substance Abuse and Mental Health Services Administration Substance Abuse Treatment for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2002 – To provide for a limitation on availability of funds for Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Mental Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Energy and Commerce

 

H.R.2001 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health Innovation Account, CURES Act for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.2000 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health Buildings and Facilities for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1999 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health Office of the Director for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1998 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Center for Advancing Translational Sciences for fiscal year 2024; Sponsor: Biggs, Andy [Rep.- R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1997 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Library of Medicine for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1996 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health John E. Fogarty International Center for fiscal year 2024. Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1995 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute on Minority Health and Health Disparities for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1994 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Center for Complementary and Integrative Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1993 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Biomedical Imaging and Bioengineering for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1992 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Human Genome Research for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1991 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Mental Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1990 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute on Drug Abuse for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1988 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Nursing Research for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1986 – 118th Congress (2023-2024) To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Arthritis and Musculoskeletal and Skin Diseases for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1985 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute on Aging for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1983 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Eye Institute for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1980 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Disease for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Energy and Commerce

 

H.R.1979 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Neurological Disorders and Stroke for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1978 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1976 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Heart, Lung, and Blood Institute for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1975 – To provide for a limitation on availability of funds for Department of Health and Human Services, National Institutes of Health National Cancer Institute for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1974 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention-Wide Activities and Program Support for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Energy and Commerce

 

H.R.1973 – To provide for a limitation on availability of Department of Health and Human Services, Centers for Disease Control and Prevention Buildings and Facilities for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1972 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention Public Health Preparedness and Response for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1971 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention Global Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1968 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention Injury Prevention and Control for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1963 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention Emerging and Zoonotic Infectious Diseases for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1962 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1961 – To provide for a limitation on availability of funds for Department of Health and Human Services, Centers for Disease Control and Prevention Immunization and Respiratory Diseases for fiscal year 2024; Sponsor: Biggs, Andy [Rep.- R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.1960 – To provide for a limitation on availability of funds for Department of Health and Human Services, Health Resources and Services Administration Program Management for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

H.R.1958 – To provide for a limitation on availability of funds for Department of Health and Human Services, Health Resources and Services Administration Rural Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1956 – To provide for a limitation on availability of funds for Department of Health and Human Services, Health Resources and Services Administration Ryan White HIV/AIDS Program for fiscal year 2024; Sponsor: Biggs, Andy [Rep.- R-AZ-5]; House – Energy and Commerce

 

H.R.1955 – To provide for a limitation on availability of funds for Department of Health and Human Services, Health Resources and Services Administration Maternal and Child Health for fiscal year 2024; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Energy and Commerce

 

H.Res.264 – Expressing support for the goals of Workplace Eye Wellness Month by promoting the importance of protecting the eyes from increased screen time; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Education and the Workforce; Energy and Commerce

 

S.Res.139 – A resolution recognizing the critical role that PEPFAR has played in the global fight against HIV/AIDS; Sponsor: Graham, Lindsey [Sen.-R-SC]; Committees: Senate – Foreign Relations

 

S.Res.144 – A resolution recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic safety; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Judiciary

 

S.Res.149 – A resolution designating the first week of April 2023 as “National Asbestos Awareness Week”; Sponsor: Tester, Jon [Sen.-D-MT]; Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent.

 

S.Res.153 – A resolution recognizing the roles and the contributions of care workers in the United States and expressing support for the designation of April 2023 as “Care Worker Recognition Month”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1069 – A bill to amend the Toxic Substances Control Act to prohibit the manufacture, processing, use, and distribution in commerce of commercial asbestos and mixtures and articles containing commercial asbestos, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Environment and Public Works

 

S.1072 – A bill to create a Council on Emergency Response Protocols to ensure the establishment of accessible, developmentally appropriate, culturally aware, and trauma-informed emergency response protocols in public schools, early child care and education settings, and institutions of higher education, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1075 – A bill to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to establish a grant program to be known as the Mental Health Licensure Portability Program to award grants to eligible entities, and for other purposes; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1077 – A bill to establish a home-based telemental health care demonstration program for purposes of increasing mental health and substance use services in rural medically underserved populations and for individuals in farming, fishing, and forestry occupations; Sponsor: Rounds, Mike [Sen.-R-SD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1110 – A bill to amend title XVIII of the Social Security Act to rebase the calculation of payments for sole community hospitals and Medicare-dependent hospitals, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.1113 – A bill to amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1114 – A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1115 – A bill to require the Secretary of Labor to revise the Standard Occupational Classification System to accurately count the number of emergency medical services practitioners in the United States; Sponsor: Casey, Robert P., Jr. [Sen.-D- PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1119 – A bill to amend title 38, United States Code, to increase the maximum age for children eligible for medical care under the CHAMPVA program, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Veterans’ Affairs

 

S.1120 – A bill to improve the actions available to eligible product developers in the event of delays in receiving covered product for purposes of generic drug or biosimilar biological product development; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1122 – A bill to improve the program to provide for priority review of human drug applications to encourage treatment for agents that present national security threats; Sponsor: Ernst, Joni [Sen.-R-IA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1125 – A bill to authorize an electronic health record modernization program of the Department of Veterans Affairs and increase oversight and accountability of the program to better serve veterans, medical professionals of the Department, and taxpayers, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.1128 – A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.1130 – A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1131 – A bill to amend title XI of the Social Security Act and title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1132 – A bill to allow sponsors of certain new drug applications to rely upon investigations conducted in certain foreign countries, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1133 – A bill to amend the Public Health Service Act to clarify rules relating to drug discounts for covered entities; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1134 – A bill to strengthen the authority of the Food and Drug Administration with respect to foreign drug facility inspections; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1135 – A bill to amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, the Internal Revenue Code of 1986, and the Patient Protection and Affordable Care Act to require coverage of hearing devices and systems in certain private health insurance plans, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1139 – A bill to amend title XVIII of the Social Security Act to apply prescription drug inflation rebates to drugs furnished in the commercial market and to change the base year for rebate calculations; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.1140 – A bill to amend the Public Health Service Act with respect to the designation of general surgery shortage areas, and for other purposes; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1141 – A bill to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Judiciary

 

S.1143 – A bill to direct the Secretary of Defense to carry out a grant program to increase cooperation on post-traumatic stress disorder research between the United States and Israel; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Foreign Relations

 

S.1150 – A bill to amend the Public Health Service Act to support and stabilize the existing nursing workforce, establish programs to increase the number of nurses, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1158 – A bill to amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

H.Res.269 – Recognizing that it is the duty of the Federal Government to develop and implement a Transgender Bill of Rights to protect and codify the rights of transgender and nonbinary people under the law and ensure their access to medical care, shelter, safety, and economic security; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Judiciary; Education and the Workforce; Energy and Commerce; Financial Services; Oversight and Accountability

H.R.12 – To protect a person’s ability to determine whether to continue or end a pregnancy, and to protect a health care provider’s ability to provide abortion services; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2400 – To amend title XIX of the Social Security Act to allow States to make medical assistance available to inmates during the 30-day period preceding their release; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.2402 – To amend the Toxic Substances Control Act to prohibit the manufacture, processing, use, and distribution in commerce of commercial asbestos and mixtures and articles containing commercial asbestos, and for other purposes; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce

 

H.R.2407 – To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2408 – To amend title XVIII of the Social Security Act to provide a review process for adverse national coverage determinations with respect to drug coverage under the Medicare program; Sponsor: Barragan, Nanette Diaz [Rep.-D- CA-44]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.2410 – To amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to provide administrative support to providers of dental care who provide such care to veterans that is not furnished under such title, to direct the Secretary of Veterans Affairs to establish a pilot program for the provision of dental care to certain veterans, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Veterans’ Affairs

 

H.R.2411 – To amend the Public Health Service Act to support and stabilize the existing nursing workforce, establish programs to increase the number of nurses, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.2412 – To amend the Public Health Service Act to authorize grants to increase national capacity to provide pediatric behavioral health services at children’s hospitals and through community-based providers to improve children’s access to care; and to authorize grants to begin to address large numbers of children boarding in emergency departments, to support the pediatric behavioral health workforce, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.2413 – To amend title 38, United States Code, to require the Secretary of Veterans Affairs to furnish dental care in the same manner as any other medical service, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.2414 – To amend title 38, United States Code, to increase the maximum age for children eligible for medical care under the CHAMPVA program, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.2416 – To amend the Public Health Service Act to reauthorize a military and civilian partnership for trauma readiness grant program; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce

 

H.R.2430 – To create a rule of construction for Federal courts to apply in all cases regarding the provision or obtaining of reproductive health services and the imposition of capital punishment; Sponsor: Mace, Nancy [Rep.-R-SC-1]; Committees: House – Judiciary

 

H.R.2431 – To authorize Department of Veterans Affairs health care providers to provide recommendations and opinions to veterans regarding participation in State marijuana programs; Sponsor: Mast, Brian J. [Rep.-R-FL-21]; Committees: House – Veterans’ Affairs

 

H.R.2433 – To amend title XVIII of the Social Security Act to update the calculation of the hospital specific rate for such hospitals, and for other purposes; Sponsor: Meuser, Daniel [Rep.-R-PA-9]; Committees: House – Ways and Means

 

H.R.2438 – To direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to establish a grant program to be known as the Mental Health Licensure Portability Program to award grants to eligible entities, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.2439 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, the Internal Revenue Code of 1986, and the Patient Protection and Affordable Care Act to require coverage of hearing devices and systems in certain private health insurance plans, and for other purposes; Sponsor: Neguse, Joe [Rep.- D-CO-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.2441 – To amend title 38, United States Code, to expand health care and benefits from the Department of Veterans Affairs for military sexual trauma, and for other purposes; Sponsor: Pingree, Chellie [Rep.-D-ME-1]; Committees: House – Veterans’ Affairs; Armed Services

 

H.R.2454 – To direct the Secretary of Defense to carry out a grant program to increase cooperation on post-traumatic stress disorder research between the United States and Israel; Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Armed Services

 

H.R.2456 – To direct the Secretary of Health and Human Services, acting through the Deputy Assistant Secretary for Women’s Health, to create educational materials with respect to covered disorders for elementary and secondary school students, and for other purposes; Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Education and the Workforce; Energy and Commerce

President Joe Biden signed the COVID-19 Origin Act (S. 619) into law last week. The legislation would require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic within 90 days. The administration can redact details to protect its sources and methods of obtaining information. The bill passed both chambers of Congress unanimously, following a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray has separately acknowledged the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan. New data was released last week, however, that provides inconclusive evidence linking COVID-19 to the DNA of racoon dogs being illegally sold at a wet seafood market in Wuhan. While the U.S. intelligence community remains split about the pandemic’s origins being animal transmitted or the result of a lab leak, the President has pledged to continue to review any links to the Wuhan Institute of Virology.

 

E&C Advances Five Health Bills

The House Energy and Commerce Committee advanced five pieces of health- related legislation last week.

The Protecting Health Care for All Patients Act (H.R. 485) would prohibit the use of quality-adjusted life years (QALYs) in federal and state programs. The bill was advanced 27-20 along party lines, with Ranking Member Frank Pallone (D-N.J.) reiterating his concerns that the bill’s prohibition on the use of QALYs to evaluate the cost- effectiveness of drugs and treatments could be used to delay or disrupt the implementation of the Inflation Reduction Act’s Medicare drug price negotiation provisions. Supporters of the bill argue that measures such as QALYs discriminate against seniors and people with disabilities.
The Block, Report, and Suspend Suspicious Shipments Act (H.R. 501) would require drug manufacturers and distributors to report and block suspicious orders of controlled substances. The bill was advanced unanimously after the adoption of an amendment specifying that the legislation does not intend to inhibit access to opioid use disorder treatment.
The 9-8-8 Lifeline Cybersecurity Responsibility Act (H.R. 498) would require the U.S. Department of Health and Human Services’ (HHS) to undertake efforts to protect the 9-8-8 Suicide & Crisis Lifeline from cybersecurity threats. It was also advanced by the committee unanimously.
The HALT Fentanyl Act (H.R. 467) would permanently place fentanyl-related substances into Schedule I of the Controlled Substances Act. Reps. Angie Craig (D-Minn.) and Kim Schrier (D-Wash.) joined panel Republicans in support of the legislation.
The Securing the Border for Public Health Act (H.R. 801) would expand HHS’ Title 42 authority to allow the HHS secretary to suspend persons and imports related to certain controlled substances from certain countries into the U.S. The bill was advanced in a party line vote.

 

Senate Commerce Committee Marks Up PBM Transparency Bill

The Senate Committee on Commerce, Science, and Transportation advanced bipartisan legislation (S. 127) last week that would prohibit pharmacy benefit managers (PBMs) from arbitrarily, unfairly, or deceptively clawing back payments made to pharmacies, or arbitrarily, unfairly, or deceptively increasing fees or lowering reimbursements to offset reimbursement changes in federally-funded health plans. The Pharmacy Benefit Manager Transparency Act of 2023 would also require PBMs to report to the Federal Trade Commission (FTC) revenue stemming from pharmacy fees and spread pricing. The bill, sponsored by Chair Maria Cantwell (D-Wash.) and Sen. Chuck Grassley (R-Iowa), was agreed to in an 18-9 vote, with some Republicans opposing the bill due to concerns about the looming 3-0 Democratic to Republican commissioner composition of the FTC. Proponents of the bill hope it will help to address both consolidation in the PBM industry and high drug prices.

 

HSGAC Chairman Peters Releases Report on Drug Shortages

Senate Committee on Homeland Security and Governmental Affairs Chairman Gary Peters (D-Mich.) has released a report on drug shortages which argues that neither U.S. regulators nor industry have enough information to predict which treatments will be in short supply and prevent future shortages. The nation is currently dealing with shortages of at least 120 drugs, with 15 critical drugs having experienced shortages for over a decade. The report blames low profit margins for old generics, manufacturing quality issues, and increased demand for persistent shortages. Peters previewed plans to introduce legislation based on the findings of his report during a hearing about drug shortages last week. The administration’s fiscal year 2024 budget request also made recommendations to improve transparency around drug shortages and require companies to extend drug expiration dates when safety permits.

 

GOP Health Leaders Inquire About MA Proposed Rule

Republican leadership of the House Energy and Commerce and Ways and Means committees sent a letter to the administration last week requesting more details about the changes to the Medicare Advantage (MA) program recently proposed by the Centers for Medicare and Medicaid Services (CMS). The letter states that House Republicans “remain committed to protecting and strengthening Medicare” and that they seek to better understand the impact of the Calendar Year 2024 Advance Notice for the MA Program on patients. CMS’ proposed regulation would make changes to the MA risk adjustment model.

 

House Panels to Investigate CMS Data Breach

Republican leadership of the House Oversight and Accountability and Energy and Commerce committees have announced an investigation into the Centers for Medicare and Medicaid Services’ (CMS) handling of an October 2022 data breach. Last year’s ransomware attack, which involved a third-party government subcontractor, impacted the personal data of more than 250,000 Medicare beneficiaries. The lawmakers criticize the agency for taking two months to characterize the hack as a major incident and to inform Congress of the event. During this time, the hackers had access to Medicare beneficiaries’ identifiable information, including names, contact information, Social Security numbers, bank account and routing numbers, Medicare enrollment details, and more. CMS has indicated that it plans to reply directly to the lawmakers’ inquiry, but also referenced a December press release on its response to the breach.

 

Tri-Caucus Urges Guardrails for Medicaid Redeterminations

The Congressional Tri-Caucus – comprised of the Congressional Hispanic Caucus, the Congressional Asian-Pacific American Caucus, and the Congressional Black Caucus – has sent a letter to the U.S. Department of Health and Human Services (HHS) urging Secretary Xavier Becerra to regulate and implement guardrails for states to follow to prevent individuals from losing Medicaid coverage for procedural reasons. Effective April 1, the fiscal year 2023 omnibus appropriations bill removed the federal continuous coverage requirement for state Medicaid programs that was instituted in response to the coronavirus pandemic, permitting states to begin eligibility redeterminations. The lawmakers ask HHS to set a high bar to prevent eligible beneficiaries from losing coverage, arguing that “such clarity will give states and territories strong new incentives for improving their policies to better protect eligible families.” The letter suggests ensuring states have sufficient staffing to process renewals, requiring state agencies to conduct electronic renewals to the maximum extent possible, and halting procedural dis-enrollments in states that do not follow the department’s unwinding guidance.

 

POLICY BRIEFINGS

 

McConnell Eager to Return to Senate

Senate Minority Leader Mitch McConnell (R-Ky.) was released from an inpatient rehabilitation facility and continues to recover at home from a concussion suffered earlier this month. He has been in touch with his colleagues and is “chomping at the bit” to return to the Senate, according to close friend Sen. John Cornyn (R-Texas). McConnell had been at an inpatient rehabilitation facility after being discharged from the hospital on March 13 following a fall at a fundraising event at a D.C.-area hotel. Senate GOP Whip John Thune (R-S.D.) also stated that he has spoken with McConnell about recent Senate floor proceedings. Last week the chamber began debate on legislation to repeal the two-decades old authorizations of use of military force against Iraq. McConnell plans to work from home this week and then the Senate will recess until April 17.

 

White House Celebrates 13th Anniversary of ACA

Democrats celebrated the 13th anniversary of the Affordable Care Act being signed into law at an event hosted by the White House on Thursday. During the event, lawmakers touted the gains made in health insurance coverage since the landmark legislation was enacted in 2010. A record-breaking 16.4 million individuals enrolled in the ACA marketplace during the 2023 open enrollment period, surpassing last year’s record of 14.5 million people. President Joe Biden called on Congress to make permanent the American Rescue Plan Act’s enhanced ACA premium subsidies, which save Americans on average more than $800 annually. The subsidies were extended through 2025 by the Inflation Reduction Act.

 

WH COVID-19 Response Team to Exit in May

The White House plans to disband its COVID-19 response team when the current COVID-19 emergency declarations expire on May 11. The Washington Post reported last week that national coordinator Ashish Jha is expected to leave the Biden administration amidst the wind down. The team under President Joe Biden is currently comprised of approximately three dozen individuals.

 

Upcoming Congressional Hearings and Markups

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies “Budget Hearing – Fiscal Year 2024 Request for the Department of Health and Human Services;” 10:00 a.m.; March 28

 

House Appropriations Department of Homeland Security Subcommittee “Budget Hearing – Fiscal Year 2024 Request for the Cybersecurity and Infrastructure Security Agency;” 10:00 a.m.; March 28

 

House Ways and Means Committee “Hearing on President Biden’s Fiscal Year 2024 Budget Request with Health and Human Services Secretary Becerra;” 2:00 p.m.; March 28

 

House Energy and Commerce Subcommittee on Health hearing “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care;” 1:00 p.m.; March 28

 

House Energy and Commerce Subcommittee on Health hearing to discuss President Biden’s FY24 Budget Request; 10:00 a.m.; March 29

 

House Natural Resources Subcommittee on Indian and Insular Affairs hearing “Challenges and Opportunities for Improving Healthcare Delivery in Tribal Communities;” 10:00 a.m.; March 29

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies “Oversight Hearing – Addressing the Challenges of Rural America;” 10:00 a.m.; March 29

 

Senate Committee on Homeland Security and Governmental Affairs markup of 28 bills; 10:30 a.m.; March 29

 

House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies “Budget Hearing – Fiscal Year 2024 Request for the Food and Drug Administration;” 1:00 p.m.; March 29

 

House Veterans’ Affairs Subcommittee on Health legislative hearing; 1:30 p.m.; March 29 Senate Finance Subcommittee on Health Care hearing “An Oral Health Crisis: Identifying and Addressing Health Disparities;” 2:30 p.m.; March 29

 

House Energy and Commerce Subcommittee on Health hearing “Reauthorization of the Animal Drug User Fee Program;” 9:00 a.m.; March 30

 

Senate Finance Committee hearing “Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers;” 10:00 a.m.; March 30

 

Recently Introduced Health Legislation

 

H.R.1666 – To amend title XVIII to protect patient access to ground ambulance services under part B of the Medicare program; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1638 -To amend title XVIII of the Social Security Act to improve access to mental health services under the Medicare program; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1637 -To recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model, and for other purposes; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1634 -To amend title XIX of the Social Security Act to cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care, to amend title XVIII of such Act to modify the requirements for diabetic shoes to be included under Medicare, and for other purposes; Sponsor: Johnson, Bill [Rep.-R-OH-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1621 -To authorize a national memorial to commemorate those whose lives were lost to COVID-19 and those who helped the country to recover, and for other purposes; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Natural Resources

 

H.R.1620 -To promote affordable access to evidence-based opioid treatments under the Medicare program and require coverage of medication assisted treatment for opioid use disorders, opioid overdose reversal medications, and recovery support services by health plans without cost-sharing requirements; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1619 -To amend the Richard B. Russell National School Lunch Act to require schools to provide fluid milk substitutes upon request of a student or the parent or guardian of such student, and for other purposes; Sponsor: Carter, Troy [Rep.-D- LA-2]; Committees: House – Education and the Workforce

 

H.R.1618 -To establish the Commission on Sustaining Medicare and Social Security, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1617 -To amend title XVIII of the Social Security Act to add physical therapists to the list of providers allowed to utilize locum tenens arrangements under Medicare; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1616 – To address research on, and improve access to, supportive services for individuals with Long COVID; Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Energy and Commerce

 

H.R.1615 – To prohibit the use of Federal funds to ban gas stoves; Sponsor: Armstrong, Kelly [Rep.-R-ND-At Large]; Committees: House – Energy and Commerce

 

H.R.1613 – To amend title XIX of the Social Security Act to improve transparency and prevent the use of abusive spread pricing and related practices in the Medicaid program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

S.Res.116 – A resolution supporting the goals and ideals of “Deep Vein Thrombosis and Pulmonary Embolism Awareness Month”; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.878 – A bill to amend the Controlled Substances Act and the Controlled Substances Import and Export Act to modify the offenses relating to fentanyl, and for other purposes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Judiciary. The press release and bill text can be found here.

 

S.880 – A bill to require MedPAC and MACPAC to biennially conduct a coordinated review and analysis of Medicare and Medicaid policy with respect to dually eligible beneficiaries, and to jointly submit recommendations for policy changes, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

S.892 – A bill to amend title XVIII of the Social Security Act to provide coverage under the Medicare program for FDA- approved qualifying colorectal cancer screening blood-based tests, to increase participation in colorectal cancer screening in under-screened communities of color, to offset the COVID-19 pandemic driven declines in colorectal cancer screening, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Finance

 

S.894 – A bill to require the Secretary of Health and Human Services to collect and disseminate information on concussion and traumatic brain injury among public safety officers; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.895 – A bill to provide for further comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.899 – A bill to prohibit the Federal Government from mandating vaccination against COVID-19 for interstate travel; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Commerce, Science, and Transportation

 

S.904 – A bill to amend title XIX of the Social Security Act to establish a demonstration project to improve outpatient clinical care for individuals with sickle cell disease; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

H.R.1671 – To allow additional individuals to enroll in standalone dental plans offered through Federal Exchanges; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Energy and Commerce

 

H.R.1672 – To amend title XIX of the Social Security Act to establish a demonstration project to improve outpatient clinical care for individuals with sickle cell disease; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Energy and Commerce

 

H.R.1675 – To provide a set-aside of funds for the territories under the health profession opportunity grant program under section 2008 of the Social Security Act, to make the Commonwealth of the Northern Mariana Islands eligible for the grants, and for other purposes; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Ways and Means

 

H.R.1689 – To authorize the Secretary of Education, in coordination with the Secretary of Health and Human Services, to award grants to eligible entities to support the mental and behavioral health of elementary and secondary school students, and for other purposes; Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House – Education and the Workforce; Energy and Commerce

 

S.923 – A bill to amend titles XVIII and XIX of the Social Security Act to reform and improve mental health and substance use care under the Medicare and Medicaid programs, and for other purposes; Sponsor: Bennet, Michael F. [Sen.- D-CO]; Committees: Senate – Finance

 

S.928 – A bill to require the Secretary of Veterans Affairs to prepare an annual report on suicide prevention, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.929 – A bill to amend the Foreign Assistance Act of 1961 to authorize the use of Federal foreign assistance funds for comprehensive reproductive health care services, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Foreign Relations

 

S.930 – A bill to amend the Omnibus Crime Control and Safe Streets Act of 1968 to provide public safety officer benefits for exposure-related cancers, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary

 

S.935 – A bill to require reporting regarding certain drug price increases, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.940 – A bill to establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.948 – A bill to amend titles XIX and XXI of the Social Security Act to improve maternal health coverage under Medicaid and CHIP, and for other purposes; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Finance

 

S.951 – A bill to establish the Office of Gun Violence Prevention, and for other purposes; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Judiciary

 

H.R.1691 – To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program, and for other purposes; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1692 – To amend the Internal Revenue Code of 1986 to improve affordability and reduce premium costs of health insurance for consumers; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Ways and Means

 

H.R.1694 – To amend titles XVIII and XIX of the Social Security Act to provide for coverage of services furnished by freestanding emergency centers; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1699 – To establish the Office of Gun Violence Prevention, and for other purposes; Sponsor: Frost, Maxwell [Rep.-D- FL-10]; Committees: House – Judiciary

 

H.R.1710 – To establish the Office of Manufacturing and Industrial Innovation Policy and strategic national manufacturing policy for the United States, to provide manufacturing and industrial perspective and advice to the President, to provide for a comprehensive survey and cross administration management of efforts to ensure global leadership in manufacturing critical to the long-term economic health and national security of the United States, and for other purposes; Sponsor: Kaptur, Marcy [Rep.-D-OH-9]; Committees: House – Energy and Commerce; Science, Space, and Technology; Financial Services

 

H.R.1711 – To establish a demonstration program to provide payments on eligible loans for individuals who are eligible for the National Health Service Corps Loan Repayment Program; Sponsor: Kustoff, David [Rep.-R-TN-8]; Committees: House – Energy and Commerce

 

H.R.1712 – To amend the Public Health Service Act to establish a rural health center innovation awards program and a rural health department enhancement program, and for other purposes; Sponsor: Kustoff, David [Rep.-R-TN-8]; Committees: House – Energy and Commerce

 

Recently Introduced Health Legislation Contd.

H.R.1717 – To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Judiciary

 

H.R.1723 – To amend the Foreign Assistance Act of 1961 to authorize the use of funds for comprehensive reproductive health care services, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Foreign Affairs

 

S.Res.123 – A resolution recognizing the week of March 19 through March 25, 2023, as “National Poison Prevention Week” and encouraging communities across the United States to raise awareness of the dangers of poisoning and promote poison prevention; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.953 – A bill to amend the Public Health Service Act to establish a rural health center innovation awards program and a rural health department enhancement program, and for other purposes; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.954 – A bill to provide for appropriate cost-sharing for insulin products covered under private health plans, and to establish a program to support health care providers and pharmacies in providing discounted insulin products to uninsured individuals; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.960 – A bill to replace the National Institute of Allergy and Infectious Diseases with 3 separate national research institutes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.964 – A bill to amend the Public Health Service Act to improve maternal health and promote safe motherhood; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.971 – A bill to amend title XIX of the Social Security Act to remove the Medicaid coverage exclusion for inmates in custody pending disposition of charges, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

H.R.1737 – To direct the Secretary of Health and Human Services to establish the Emergency Medical Services (EMS) Grant Program through which the Secretary may make grants to qualified applicants, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House – Energy and Commerce

 

H.R.1745 – To amend titles XI and XVIII of the Social Security Act to strengthen health care waste, fraud, and abuse provisions; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1746 – To amend title XVIII of the Social Security Act to establish requirements for the provision of certain high- cost durable medical equipment and laboratory testing, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1754 – To amend title XI of the Social Security Act to provide for the disclosure and analysis of certain health-related ownership information; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1758 – To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances; Sponsor: Luetkemeyer, Blaine [Rep.-R-MO-3]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1768 – To replace the National Institute of Allergy and Infectious Diseases with 3 separate national research institutes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Energy and Commerce

 

H.R.1769 – To amend the Internal Revenue Code of 1986 to create health freedom accounts available to all individuals; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Ways and Means

 

H.R.1770 – To amend title XVIII of the Social Security Act to provide pharmacy payment of certain services; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1773 – To amend the Fair Debt Collection Practices Act to provide a timetable for the collection of medical debt by debt collectors, to amend the Fair Credit Reporting Act to prohibit consumer reporting agencies from issuing consumer reports containing information about debts related to medically necessary procedures, and for other purposes; Sponsor: Tlaib, Rashida [Rep.-D-MI-12]; Committees: House – Financial Services

Bipartisan leadership of the Senate Health, Education, Labor and Pensions (HELP) Committee is requesting input from public health officials, health care providers, and other stakeholders on policies the panel should consider as it works to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA). The law, which was originally passed in 2006, must be reauthorized every five years. Chairman Bernie Sanders (I-Vt.), Ranking Member Bill Cassidy (R-La.), Sen. Bob Casey (D-Pa.), and Sen. Mitt Romney (R-Utah) specifically ask for feedback on the effectiveness of existing programs, how to improve the ability of states and localities to respond to public health crises, any gaps in activities or authorities in the PAHPA framework, and ways to strengthen partnerships between the federal government, states and localities, the private sector, and non-government stakeholders. Authorization for most PAHPA programs expires at the end of the fiscal year on September 30. Comments should be submitted to [email protected] no later than March 29, 2023.

 

HELP to Hold Series of Round-Table Discussions

Senate HELP Chairman Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) informed committee members last week about their plans to hold the following series of closed, informal round-table discussions:

• March 23, on the need to improve apprenticeship programs • March 28, on patient access to complimentary medicine
• April 18, on the need to support the aging population
• April 20, on surprise medical billing patient protections
• April 26, on transparency in the cost of health care services

According to Sanders and Cassidy, the purpose of these meetings will be to expedite the HELP Committee’s work and to “see what kind of bipartisan consensus we might be able to achieve.”

 

CBO Scales Back Prior Health Care Cost Projections

The Congressional Budget Office (CBO) is predicting lower-than-previously-expected government health care costs for at least the next decade. In a response to an inquiry from the office of Sen. Sheldon Whitehouse (D-R.I.) last week, the government budget agency says that it overestimated projections for federal health care spending between 2010 and 2020. Mandatory outlays for these budget categories, which includes Medicare and Medicaid, were 9% less than predicted in 2010 – amounting to a total of $1.1 trillion less in money spent per beneficiary. CBO attributes this decline to lower than anticipated Medicare prescription drug costs and costs for Medicaid enrollees with disabilities and chronic conditions. While growth in Medicare spending per beneficiary increased at an average annual rate of 6.6% from 1987 to 2005, the growth slowed to 2.2% per year as of 2019.

 

JAMA Publishes Study on Provider Directories

Anew study published in the Journal of the American Medical Association last week reveals that more than 80% of physicians have inconsistent or incorrect entries listed in health insurance provider directories. The study covered all physicians in the publicly available directories of the five major national health insurers – UnitedHealth, Elevance, Cigna, Aetna, and Humana. Among those physicians listed in more than one directory, only 19.4% had consistent address and specialty information across all directories in which they were found. Approximately 28% had consistent practice location addresses and 68% had consistent specialty information. Consistency of information decreased as physician data was drawn from an increasing number of insurers. The information of physicians with only one practice location fared best – 85% saw consistent practice location addresses and 69% saw consistent specialty information across directories.

 

More Companies Announce Price Caps on Insulin Products

The three major insulin manufacturers in the U.S. – Sanofi, Eli Lilly, and Novo Nordisk – have all announced plans in recent weeks to significantly reduce the prices of their insulin products and cap patients’ monthly costs at $35. Together, the companies represent 90% of the nation’s insulin market. President Joe Biden praised the decisions but continued to urge Congress to pass legislation to ensure that all individuals can access insulin for no more than $35 per month.

 

Chairman Tester Calls on VA, Oracle Cerner to Fix Challenges with EHR System

During an oversight hearing last week, Senate Committee on Veterans’ Affairs Chairman Jon Tester (D-Mont.) urged the Department of Veterans Affairs (VA) and Oracle Cerner to resolve the challenges facing the Electronic Health Record Modernization (EHRM) program before expanding it to other hospitals and clinics. Oracle Cerner’s EHRM program has faced scrutiny for glitches that led to poor health outcomes and some deaths. At the same hearing, the Government Accountability Office (GAO) reported on issues with the VA’s EHRM program and made ten recommendations for the agency to address its concerns. To enhance transparency, Tester and Ranking Member Jerry Moran (R-Kan.) championed the recently enacted VA Electronic Health Record Transparency Act of 2021, which requires the VA to submit periodic reports to Congress on costs, performance metrics, and outcomes related to the EHRM. The EHRM program aims to replace the complex IT program that was in place at the department for 30 years to better integrate with the Department of Defense, Coast Guard, and other care providers. Currently, the program is only in use in five hospitals, 22 clinics, and 52 remote sites. House Committee on Veterans’ Affairs Chairman Mike Bost (R-Ill.) and House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) introduced the VA Electronic Health Record Modernization Improvement Act (H.R. 592), which would halt deployment of Oracle Cerner’s EHRM system until improvements are made to prevent harm to beneficiaries. The current contract between VA and Oracle Cerner expires in mid-May.

 

VHA to Cover Leqembi to Treat Alzheimer’s Disease

The Veterans Health Administration (VHA) announced last week that it will now cover LeqembiTM, a new monoclonal antibody treatment for veterans with early-stage Alzheimer’s disease. Developed by Eisai in partnership with Biogen, the Food and Drug Administration (FDA) approved the treatment under the accelerated approval pathway in January. However, the Centers for Medicare and Medicaid Services (CMS) only allows narrow coverage of the treatment, limiting it to Medicare beneficiaries in clinical trials. The Alzheimer’s Association requested that CMS reconsider its coverage policy, but the agency reiterated its position in a statement. Nevertheless, Chair of the House Energy and Commerce Committee Cathy McMorris Rodgers (R-Wash.) welcomed VHA’s announcement and called on CMS to reconsider its coverage policy. The FDA is expected to make a decision on full traditional approval of the drug in July.

 

Durbin Urges Increased Federal Coordination on Unauthorized Vapes

Sen. Dick Durbin (D-Ill.) is asking the Food and Drug Administration (FDA) and Department of Justice to better coordinate their work to prevent unauthorized vaping products from entering the market. “Every single day in America, children pick up vaping with unauthorized products that are on store shelves only because FDA has seemingly granted these illegal e-cigarettes a free pass,” his letter states. “I write to express my concern that the Biden administration has not taken more aggressive enforcement action to stop thousands of illegal e-cigarettes from flooding the market and addicting children.” He requests a response by April 7, 2023, to provide an update on interagency effort progression.

 

Hassan, Paul Introduce Bill to Speed Generic Approvals

Sens. Maggie Hassan (D-N.H.) and Rand Paul (R-Ky.) reintroduced the Increasing Transparency in Generic Drug Applications Act (S. 775) last week. The bill aims to lower the price of prescription drugs by streamlining the generic drug approval process to bring lower-cost competition to market faster. It would require the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The agency is currently unable to disclose the specific differences in inactive ingredients between a generic application and the reference product.

 

POLICY BRIEFINGS

 

McConnell Discharged from Hospital, Begins Physical Therapy

Sen. Mitch McConnell (R-Ky.) has been discharged from the hospital after being treated for a concussion. The Senate Minority Leader fell following a fundraising event at a D.C.-area hotel and suffered a fractured rib in addition to the concussion. He has started in-patient physical therapy at a rehabilitation facility. McConnell’s office did not state when he plans to return to the Senate.

The Senate has been significantly impacted by absences in recent months. In addition to McConnell, Sen. John Fetterman (D-Pa.) remains in treatment for depression, and Sen. Dianne Feinstein (D-Calif.) is expected to remain absent this week following her diagnosis with shingles in February. The last time all 100 members of the chamber attended a vote was August 7, 2022 for passage of the Inflation Reduction Act along party-lines.

 

MedPAC, MACPAC March Reports to Congress

The congressional advisory panels charged with advising lawmakers on issues affecting the Medicare, Medicaid, and CHIP programs released their annual March reports to Congress last week. The Medicare Payment Advisory Commission’s (MedPAC) report evaluates payment adequacy and makes recommendations concerning Medicare fee- for-service (FFS) payment policy in 2024 for seven FFS payment systems: acute care hospital, physician and other health professional, outpatient dialysis facility, skilled nursing facility, home health agency, inpatient rehabilitation facility, and hospice services. The report also includes a chapter on the current context of Medicare program payment policy and status reports on ambulatory surgical centers, the Medicare Advantage program, and on Medicare Part D. Notably, the MedPAC report recommends that Congress update the Medicare base payment rate for physician and other health professional services by 50% of the projected increase in the Medicare Economic Index. The Medicaid and CHIP Payment and Access Commission (MACPAC) report includes four chapters on the following topics: (1) Medicaid race and ethnicity data collection and reporting, (2) principles for assessing Medicaid nursing facility payment programs, (3) strengthening evidence under Medicaid drug coverage, and (4) the statutorily required review of hospital payment policy for the nation’s safety-net hospitals.

 

First of ARPA-H Hubs to be Located in D.C. Region

The Advanced Research Projects Agency for Health (ARPA-H) announced last week that the Washington, D.C. region will serve as one of its three headquarters across the country. A site solicitation has been opened to help choose the remaining two hubs for the new biomedical innovation agency, which will be announced by fall. ARPA-H leadership intends to fill each office with 85-100 staff personnel. The agency’s authorizing legislation specified that it cannot be situated on the campus of the National Institutes of Health in Bethesda, Maryland, but placed no further restrictions on location. ARPA-H’s first two program managers, Paul Sheehan and Ross Uhrich, were also announced last week. Sheehan currently serves as a program manager in the Defense Advanced Research Projects Agency’s Biological Technologies Office, and Uhrich is an assistant professor of surgery at Walter Reed National Military Medical Center.

 

CDC Releases Latest Maternal Mortality Data

The Centers for Disease Control and Prevention released new data last week showing a 40% increase in the number of maternal deaths across the U.S. in 2021. The total rate of pregnancy-related deaths reached 32.9 deaths per 100,000 live births, but this rate was 2.6 times higher for Black individuals – reaching 69.9 deaths per 100,000 live births – and 1.4 times higher for Hispanic people – reaching 26.6 deaths per 100,000 live births. The data from the National Center for Health Statistics reflects death certificate information for individuals who died during and up to 42 days after pregnancy. According to the report’s author, an initial review indicates that COVID-19 likely contributed to the increase in maternal mortality. The U.S. ranks far below most other wealthy nations in rates of pregnancy-related deaths.

 

Upcoming Congressional Hearings and Markups

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

Senate Finance Committee hearing “The President’s Fiscal Year 2024 Health and Human Services Budget;” 10:00 a.m.; March 22

 

Senate Homeland Security and Government Affairs Committee hearing “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms;” 10:00 a.m.; March 22

 

Senate Commerce, Science, and Transportation Committee markup including S. 90, Informing Consumers About Smart Devices Act, and S. 127, Pharmacy Benefit Manager Transparency Act; 10:00 a.m.; March 22

 

Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee hearing “A Review of the President’s FY 2024 Funding Request and Budget Justification for the Department of Health and Human Services;” 2:30 p.m.; March 22

 

House Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee member day hearing; 10:00 a.m.; March 23

 

House Homeland Security Subcommittee on Cybersecurity and Infrastructure Protection hearing “CISA 25: The State of American Cybersecurity from a Stakeholder Perspective;” 10:00 a.m.; March 23

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

House Energy and Commerce Subcommittee on Health hearing “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care;” 1:00 p.m.; March 28

 

House Energy and Commerce Subcommittee on Health hearing to discuss President Biden’s FY24 Budget Request; 10:00 a.m.; March 29

 

Recently Introduced Health Legislation

 

H.R.1570 – To enhance mental health and psychosocial support within United States development and humanitarian assistance programs; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Foreign Affairs

 

H.R.1565 -To amend title XVIII of the Social Security Act to remove the 96-hour physician certification requirement for inpatient critical access hospital services; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means

 

H.R.1557 – To require the Secretary of Health and Human Services to submit a report on the interoperability of medical devices; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce

 

H.R.1551 – To amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; House – Energy and Commerce

 

H.R.1549 – To amend the Controlled Substances Act to prohibit the knowing possession of a pill press mold with intent to manufacture in violation of such Act a counterfeit substance in schedule I or II in a capsule, tablet, and other form intended for distribution, and for other purposes; Sponsor: Kustoff, David [Rep.-R-TN-8]; Committees: House – Judiciary; Energy and Commerce

 

H.R.1546 – To prohibit the use of funds to implement any obligations of the United States under the World Health Organization’s Global Pandemic Treaty; Sponsor: Jackson, Ronny [Rep.-R-TX-13]; Committees: House – Foreign Affairs

 

H.R.1539 – To amend the Richard B. Russell National School Lunch Act to require schools to provide fluid milk substitutes upon request of a student or the parent or guardian of such student, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Education and the Workforce

 

H.Res.224 -Raising awareness of the racial disparities in the impact of colorectal cancer on the Black community; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

S.775 – A bill to provide for increased transparency in generic drug applications; Sponsor: Hassan, Margaret Wood [Sen.- D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.786 – A bill to amend the Internal Revenue Code of 1986 to treat certain amounts paid for physical activity, fitness, and exercise as amounts paid for medical care; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.793 – A bill to amend title XVIII of the Social Security Act to add physical therapists to the list of providers allowed to utilize locum tenens arrangements under Medicare; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Finance

 

S.799 – A bill to amend title XVIII of the Social Security Act to provide Medicare coverage for all physicians’ services furnished by doctors of chiropractic within the scope of their license, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

H.Res.232 – Recognizing the importance of sleep health and expressing support for the designation of the week of March 12 through March 18, 2023, as “Sleep Awareness Week”; Sponsor: Raskin, Jamie [Rep.-D-MD-8]; Committees: House – Energy and Commerce

 

H.R.1575 – To require the Secretary of Health and Human Services to award grants to pregnancy-help organizations; Sponsor: Fulcher, Russ [Rep.-R-ID-1]; Committees: House – Energy and Commerce

 

H.R.1580 – To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; Sponsor: Johnson, Mike [Rep.-R-LA-4]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1582 – To amend the Internal Revenue Code of 1986 to treat certain amounts paid for physical activity, fitness, and exercise as amounts paid for medical care; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

 

H.R.1587 – To provide for appropriate cost-sharing for individuals 26 years of age or younger for insulin products covered under private health plans and Medicaid; Sponsor: Landsman, Greg [Rep.-D-OH-1]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.1597 – To amend the Controlled Substances Act with respect to a penalty for illicit fentanyl and fentanyl-related substances; Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House – Judiciary; Energy and Commerce

 

H.R.1610 -To amend title XVIII of the Social Security Act to provide Medicare coverage for all physicians’ services furnished by doctors of chiropractic within the scope of their license, and for other purposes; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Energy and Commerce; Ways and Means

 

S.801 – A bill to address research on, and improve access to, supportive services for individuals with Long COVID; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.803 – A bill to amend the title XVIII of the Social Security Act to preserve access to rural health care by ensuring fairness in Medicare hospital payments; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.818 – A bill to promote affordable access to evidence-based opioid treatments under the Medicare program and require coverage of medication assisted treatment for opioid use disorders, opioid overdose reversal medications, and recovery support services by health plans without cost-sharing requirements; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.838 – A bill to amend title XVIII of the Social Security Act to improve access to mental health services under the Medicare program; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.842 – A bill to amend titles XVIII and XIX of the Social Security Act to provide for coverage of dental and oral health services, vision services, and hearing services under the Medicare and Medicaid programs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.845 – A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.853 – A bill to direct the Secretary of Veterans Affairs to establish the Zero Suicide Initiative pilot program of the Department of Veterans Affairs; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Veterans’ Affairs

 

S.862 – A bill to address health workforce shortages through additional funding for the National Health Service Corps, and to establish a National Health Service Corps Emergency Service demonstration project; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

The White House released the President’s fiscal year (FY) 2024 budget proposal last week. While the plan does not have any chance of being adopted by Congress, it represents the administration’s policy priorities and provides a starting point for Democratic appropriators as negotiations get underway on FY24 spending bills in the divided congress. The $6.9 trillion budget request, which seeks a 3.3% increase in defense spending and a 6.5% increase for nondefense discretionary programs, would increase taxes by $5.5 trillion and reduce the deficit by more than $2 trillion over the next 10 years. The U.S. Department of Health and Human Services would see an 11.5% increase to its overall budget. This includes $144.3 billion in discretionary and $1.7 trillion in mandatory proposed budget authority. The HHS Budget in Brief can be found here.

A main component of the budget focuses on Medicare solvency. The President proposes to increase the Medicare tax rate from 3.8% to 5% on earned and unearned income above $400,000, as well as to eliminate a tax loophole that allowed certain business owners to avoid paying Medicare taxes on some of their income. The President proposes to dedicate proceeds from the net investment income tax to Medicare’s Hospital Insurance (Part A) Trust Fund. The budget would also strengthen the Medicare program’s drug pricing negotiation authority as established by the Inflation Reduction Act by doubling the number of drugs subject to Medicare negotiation – to 20 Part D drugs in 2026, and 40-Part B and Part D drugs each subsequent year. The budget would also decrease the number of years treatments are excluded from negotiation to five years. The White house estimates that these provisions would save $200 billion over the next decade to extend the solvency of the Medicare program.

 

Casey, Tillis Circulate Dear Colleague on NIH Funding

Sens. Bob Casey (D-Pa.) and Thom Tillis (R-N.C.) are circulating their annual Dear Colleague letter in support of robust funding for the National Institutes of Health (NIH). The letter to Senate appropriations leadership urges them “to consider the tremendous benefits of sustained investment in the NIH and…remember our Nation’s role as a world leader in biomedical research and the impact this research has on the American people.” Casey and Tillis also ask appropriators to include the full allocation of funding for the NIH as provided by the 21st Century Cures Act. Members have until April 7th to sign on to the letter.

 

Bill to Declassify COVID-19 Origin Information Sent to President

The House of Representatives voted 419-0 to require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic. Passage of the COVID-19 Origin Act (S. 619) follows a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray has separately acknowledged the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan. The bill, which was previously passed by the Senate on March 1, will now be sent to President Joe Biden’s desk for his signature.

 

Senate Confirms Head of Administration for Native Americans

The Senate confirmed Patrice H. Kunesh to serve as commissioner of the Administration for Native Americans at the U.S. Department of Health and Human Services by a vote of 57-35. Kunesh, of Standing Rock Lakota descent, is an attorney and policy advocate. During her career she has worked as a public servant at the tribal, state, and federal levels.

 

H.R.1, the Lower Energy Costs Act

House Speaker Kevin McCarthy (R-Calif.) announced last week that H.R. 1 for the 118th Congress will be the Lower Energy Costs Act. The bill aims to increase the production and export of American energy and reduce regulatory burdens. It includes legislation originating from the Energy and Commerce, Natural Resources, and Transportation and Infrastructure committees. Per House rules, the first ten numbers for bills are reserved for the Speaker to assign and the second ten numbers for the Minority Leader. Legislation numbered H.R. 1 to H.R. 20 typically signifies priority issues for the majority and minority parties.

 

E&C Health Subcommittee Advances Five Bills

The House Energy and Commerce Subcommittee on Health advanced five pieces of health-related legislation last week.

The Protecting Health Care for All Patients Act (H.R. 485) would prohibit the use of quality-adjusted life years (QALYs) in federal and state programs. Key lawmakers have stated that they are close to reaching a bipartisan agreement on the bill, which was introduced by Committee Chair Cathey McMorris Rodgers (R-Wash.). Ranking Member Frank Pallone (D-N.J.) has expressed concerns that the legislation could prevent the measurement of pharmaceutical cost-effectiveness in Medicare drug price negotiations, while proponents of the bill believe QALYs devalue the lives of people with disabilities. Health Subcommittee Ranking Member Anna Eshoo (D-Calif.) said during the markup that an agreement on the bill is “extremely close,” and Pallone said he is seeking input from Armed Services and Veterans Affairs policymakers on the potential impact of the measure on programs within their jurisdiction.
The Block, Report, and Suspend Suspicious Shipments Act (H.R. 501) would require drug manufacturers and distributors to report and block suspicious orders of controlled substances.
The 9-8-8 Lifeline Cybersecurity Responsibility Act (H.R. 498) would require the U.S. Department of Health and Human Services’ (HHS) to undertake efforts to protect the 9-8-8 Suicide & Crisis Lifeline from cybersecurity threats.
The HALT Fentanyl Act (H.R. 467) would permanently place fentanyl-related substances into Schedule I of the Controlled Substances Act.
The Securing the Border for Public Health Act (H.R. 801) would allow the HHS secretary to suspend persons and imports related to certain controlled substances from certain countries into the U.S.

 

Hassan, Braun Weigh in on Health Price Transparency Implementation

Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) are asking the White House to close certain loopholes they argue are being used by the health insurance industry to prevent health care price transparency. Both Hassan and Braun are members of the Health, Education, Labor and Pensions Committee. The lawmakers call on the Centers for Medicare and Medicaid Services (CMS) to revise the process for filing price data as required by the 2020 Transparency in Coverage Final Rule. “Americans should not struggle with opaque pricing for health care, and we respectfully ask CMS to update its rule to ensure that there is true health plan transparency and compliance,” the letter states. They suggest the agency limit file sizes, create standardized reporting, reduce the frequency of reporting, and require a clear organizational system and standardized labeling of reported health care price data. Hassan and Braun also ask CMS to increase enforcement against plans that provide low-quality data or no data at all.

 

POLICY BRIEFINGS

 

Coronavirus Panel Requests Details on Political Interference in Vaccine Approvals

Republicans on the House Select Subcommittee on the Coronavirus Pandemic are requesting information from the Biden administration related to the Food and Drug Administration’s COVID-19 vaccine approval process. The lawmakers assert that the agency “may have bypassed, wrongly compressed, and possibly compromised the longstanding process for awarding a full biologics approval to a vaccine.” The letter asserts that this effort “may not have been to save lives, but concernedly to provide cover for implementing and enforcing vaccine mandates across the country.”

 

Reps. Kim, Kelly to Lead Maternity Care Caucus

Reps. Young Kim (R-Calif.) and Robin Kelly (D-Ill.) will serve as co-chairs of the bipartisan Maternity Care Caucus for the 118th Congress. Kim and Kelly replace outgoing co-chairs Reps. Lucille Roybal-Allard (D-Calif.) and Jaime Herrera Beutler (R-Wash.). The new co-chairs have highlighted their goal of exploring the biggest challenges to America’s maternity care system and the most promising solutions to expand safe and effective care for mothers and babies. These include increasing access to and expanding training for the material health care workforce, improving maternal mental health, addressing disparities in maternal mortality rates, expanding access to telehealth, and increasing clinical trial participation among pregnant and breastfeeding women.

Rep. McClain Joins Mental Health Task Force Leadership

Rep. Lisa McClain (R-Mich.) will serve as the fourth co-chair of the Bipartisan Mental Health and Substance Use Disorder Task Force for the 118th Congress. The 130-member caucus aims to combat the mental health and substance use disorder epidemics in American communities. McClain joins current co-chairs David Trone (D-Md.), Brian Fitzpatrick (R-Pa.), and Ann Kuster (D-N.H.).

Democratic Health Leaders Praise Proposed Rollback of Conscience Regulations

On March 7, House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), House Education and the Workforce Committee Ranking Member Bobby Scott (D-Va.), and House Ways and Means Committee Ranking Member Richard Neal (D-Mass.) sent a letter to the U.S. Department of the Health and Human Services (HHS) in support of the Office for Civil Rights’ notice of proposed rulemaking, “Safeguarding the Rights of Conscience as Protected by Federal Statues.” The proposed rule seeks to partially rescind a 2019 rule promulgated during the Trump administration that allowed medical professionals the ability to deny care based on religious or conscience objections. The 2019 rule was blocked by federal courts in response to several lawsuits. The letter expresses the members’ support for HHS’ partial recission of the rule “because it aims to restore the balance between enforcing conscience laws and ensuring that individuals have unimpeded access to comprehensive health care services. Having access to health care services is critical, especially for certain communities such as racial and ethnic minorities, women, and LGBTQ+ individuals who have historically faced barriers to access in our health care system, and often continue to face discrimination in access to care today.”

 

Democrats Criticize Walgreens’ Plan for Mifepristone Dispensing

Agroup of 12 Democratic Senators have sent a letter to Walgreens CEO Rosalind Brewer criticizing the company’s stated plans for its Mifepristone dispensing policies. While Walgreens is seeking pharmacy certification to dispense the medical pregnancy termination drug through the Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy program, it has also informed 20 Republican state attorneys general that it will avoid dispensing the product in certain states – mostly those where abortion is banned or heavily restricted – that have threatened legal action. “We urge Walgreens demonstrate its commitment to putting patients first by prioritizing obtaining FDA specialty certification to dispense Mifepristone and publicly clarifying that any hypothetical dispensing decisions remain undecided and premature at best, while the company seeks pharmacy certification,” the letter states.

 

McConnell Hospitalized with Concussion Following Fall

Senate Minority Leader Mitch McConnell (R-Ky.) was hospitalized last week after a fall at a Washington, D.C. area hotel. The Minority Leader suffered a concussion and is being treated at a D.C.-area hospital. McConnell is expected to remain in the hospital for a few days of observation and treatment.

 

Representative Jennifer McClellan sworn into the House of Representatives

On March 7, Rep. Jennifer McClellan (D-Va.) was sworn into the U.S. House of Representatives to represent Virginia’s fourth district. Rep. McClellan was elected in a special election on February 21st to succeed the late-Rep. Donald McEachin (D-Va.)-who passed away of complications of colorectal cancer three weeks after being re-elected to the seat in November. McClellan makes history as the first Black woman to represent the state of Virginia in Congress. With Representative McClellan, the number of women serving in Congress reached a record high at 150. In addition, the House is now operating at full membership, a first since 2019, with 435 seats occupied in the 118th Congress. This slightly shifts the balance of power in the chamber-narrowing Republican’s majority to 222 to 213.

 

HHS OIG Issues Reminder on Expiration of PHE

The U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a notice last week reminding the health care community that OIG flexibilities issued during the time period covered by the COVID-19 public health emergency (PHE) declaration will expire on May 11. These flexibilities – covered by two policy statements and a series of frequently asked questions – were designed to minimize burdens for the health care industry as it faced the challenges of the COVID-19 pandemic. More information on what each flexibility did can be found here.

 

ASPR Releases Cybersecurity Guide for Health Care Sector

The Administration for Strategic Preparedness and Response (ASPR) released the Cybersecurity Framework Implementation Guide last week to support the health care sector in preventing cybersecurity incidents. The document, which was jointly developed by ASRP and the Health Sector Coordinating Council Cybersecurity Working Group, outlines steps organizations can immediately take to manage cyber risks to their information technology systems. It aims to assist health care organizations in implementing the National Institute for Standards and Technology’s Cybersecurity Framework, including by guiding risk management principles and best practices; providing common language to address and manage cybersecurity risk; outlining a structure for organizations to understand and apply cybersecurity risk management; and identifying effective standards, guidelines, and practices to manage cybersecurity risk cost-effectiveness based on business needs.

 

HHS Update on Pandemic Accord

The U.S. Department of Health and Human Services (HHS) has provided an update on work among the Intergovernmental Negotiating Body of the World Health Organization on a pandemic accord. According to HHS, the U.S. sought to “promote an accord that would build capacity, reduce the threat posed by zoonotic disease, enable rapid and more equitable responses, and establish sustainable financing, governance, and accountability to break the cycle of pandemic panic and neglect” at the fourth meeting of the Intergovernmental Negotiating Body last week. Its next meeting will take place in a month. The group aims to conclude its work on a pandemic accord in May 2024.

 

Upcoming Congressional Hearings and Markups

 

Senate Veterans’ Affairs Committee hearing “Examining the Future Path of VA’s Electronic Health Record Modernization Program;” 3:30 p.m.; March 15

 

Senate Energy and Natural Resources Committee meeting to receive a closed briefing on the assessment of the origins of COVID-19; 9:30 a.m.; March 16

 

Senate Homeland Security and Government Affairs Committee hearing “In Need of a Checkup: Examining the Cybersecurity Risks to the Healthcare Sector;” 10:00 a.m.; March 16

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

House Energy and Commerce Subcommittee on Health hearing “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care;” 1:00 p.m.; March 28

 

Recently Introduced Health Legislation

 

H.R.1376 – To require the Director of National Intelligence to declassify information relating to the origin of COVID-19, and for other purposes; Sponsor: Turner, Michael R. [Rep.-R-OH-10]; Committees: House – Intelligence; Energy and Commerce

 

H.R.1375 – To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.1374 – To amend the Higher Education Act of 1965 to prohibit the imposition of COVID-19 vaccine mandates by institutions of higher education, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Education and the Workforce

 

H.R.1373 – To prohibit any head of a Federal agency from providing assistance to the Wuhan Institute of Virology and other laboratories in certain other foreign nations; Sponsor: Stewart, Chris [Rep.-R-UT-2]; Committees: House – Foreign Affairs

 

H.R.1361 – To authorize the Director of the Bureau of Justice Assistance to make grants to States, units of local government, and gun dealers to conduct gun buyback programs, and for other purposes. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Judiciary

 

H.R.1360 – To establish a cybersecurity literacy campaign, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R- CA-23]; Committees: House – Energy and Commerce

 

H.R.1359 – To expand the take-home prescribing of methadone through pharmacies; Sponsor: Norcross, Donald [Rep.- D-NJ-1]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1352 – To require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1350 – To amend the Internal Revenue Code of 1986 to restore the amount of the orphan drug tax credit, and for other purposes; Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1346 – To require the Director of National Intelligence to declassify information relating to the origin of COVID-19, and for other purposes; Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House – Intelligence (Permanent Select); Energy and Commerce

 

H.R.1345 – To amend the National Telecommunications and Information Administration Organization Act to establish the Office of Policy Development and Cybersecurity, and for other purposes; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Energy and Commerce

 

H.R.1342 – To amend title XIX of the Social Security Act to improve coverage of dental and oral health services for adults under Medicaid, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; House – Energy and Commerce

 

H.Res.196 – Memorializing those impacted by and lost to the COVID-19 pandemic; Sponsor: Stanton, Greg [Rep.-D- AZ-4]; Committees: House – Energy and Commerce

 

S.Res.94 – A resolution memorializing those lost to the COVID-19 pandemic; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

Recently Introduced Health Legislation Contd.

 

S.655 – A bill to amend the Internal Revenue Code of 1986 to permit high deductible health plans to provide chronic disease prevention services to plan enrollees prior to satisfying their plan deductible; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.663 – A bill to amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with metastatic breast cancer, and for other purposes; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Finance

 

S.665 – A bill to provide incentives to physicians to practice in rural and medically underserved communities, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary

 

S.Res.95 – A resolution honoring the life of Dr. Paul Farmer by recognizing the duty of the Federal Government to adopt a 21st century global health solidarity strategy and take actions to address past and ongoing harms that undermine the health and well-being of people around the world; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Foreign Relations

 

S.669 – A bill to amend title XVIII of the Social Security Act to expand access to psychological and behavioral services; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance

 

S.689 – A bill to amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

H.Res.204 – Honoring the life of Dr. Paul Farmer by recognizing the duty of the Federal Government to adopt a 21st- century global health solidarity strategy and take actions to address past and ongoing harms that undermine the health and well-being of people around the world; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Foreign Affairs; Judiciary

 

H.R.1385 – To amend title XXVII of the Public Health Service Act to improve health care coverage under vision and dental plans, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.1393 – To amend the Controlled Substances Act to define currently accepted medical use with severe restrictions, and for other purposes; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1399 – To amend chapter 110 of title 18, United States Code, to prohibit gender affirming care on minors, and for other purposes; Sponsor: Greene, Marjorie Taylor [Rep.-R-GA-14]; Committees: House – Judiciary; Ways and Means; Energy and Commerce; Education and the Workforce

 

H.R.1402 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to provide coverage for boxing-based exercise classes for veterans diagnosed with certain movement disorders, and for other purposes; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Veterans’ Affairs

 

H.R.1406 – To amend title XVIII of the Social Security Act to permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19, and for other purposes; Sponsor: Joyce, John [Rep.-R- PA-13]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1422 – To amend title XIX of the Social Security Act to improve oral health care and dental benefits under the Medicaid program, and for other purposes; Sponsor: Simpson, Michael K. [Rep.-R-ID-2]; Committees: House – Energy and Commerce

 

H.R.1423 – To authorize the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to States, territories, political subdivisions of States and territories, Tribal governments, and consortia of Tribal governments to establish an unarmed mobile crisis response program, and for other purposes; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce

 

H.R.1425 – To require any convention, agreement, or other international instrument on pandemic prevention, preparedness, and response reached by the World Health Assembly to be subject to Senate ratification; Sponsor: Tiffany, Thomas P. [Rep.-R-WI-7]; Committees: House – Foreign Affairs

 

S.701 – A bill to protect a person’s ability to determine whether to continue or end a pregnancy, and to protect a health care provider’s ability to provide abortion services; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time

 

S.703 – A bill to amend title XVIII of the Social Security Act to make improvements to the redistribution of residency slots under the Medicare program after a hospital closes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Finance

 

S.704 – A bill to amend the Higher Education Act of 1965 to provide for interest-free deferment on student loans for borrowers serving in a medical or dental internship or residency program; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.705 – A bill to amend the Public Health Service Act to authorize a loan repayment program to encourage specialty medicine physicians to serve in rural communities experiencing a shortage of specialty medicine physicians, and for other purposes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.708 – A bill to improve outcomes for Medicaid beneficiaries with major depressive disorder or other mental health conditions; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance

 

S. 712 – A bill to identify and address barriers to coverage of remote physiologic devices under State Medicaid programs to improve maternal and child health outcomes for pregnant and postpartum women; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate — Finance

 

S.723 – A bill to amend titles XVIII and XIX of the Social Security Act to provide for coverage of prescription digital therapeutics under such titles, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Finance

 

H.Res.213 – Supporting the designation of March 2023 as National Colorectal Cancer Awareness Month; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

 

H.R.1458 – To amend titles XVIII and XIX of the Social Security Act to provide for coverage of prescription digital therapeutics under such titles, and for other purposes; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1466 – To amend the Public Health Service Act to prohibit research with human fetal tissue obtained pursuant to an abortion, and for other purposes; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Energy and Commerce

 

H.R.1475 – To direct the Secretary of Health and Human Services to develop and nationally disseminate accurate, relevant, and accessible resources to promote understanding about sensitivities regarding adoption in the health care industry, and for other purposes; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Education and the Workforce

 

S.727 – A bill to limit the price charged by manufacturers for insulin; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.729 – A bill to amend title XVIII of the Social Security Act to provide for the waiver of certain telehealth requirements to permit reimbursement for audio-only telehealth services under the Medicare program during emergency declarations; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

S.730 – A bill to amend title XVIII of the Social Security Act and the SUPPORT for Patients and Communities Act to provide for Medicare and Medicaid mental and behavioral health treatment through telehealth; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

S.731 – A bill to amend the Internal Revenue Code of 1986 to make permanent the permissible first-dollar coverage of telehealth services for purposes of health savings accounts; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

S.750 – A bill to amend title III of the Public Health Service Act to prohibit health centers from providing abortions, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.762 – A bill to amend title XIX of the Social Security Act to require coverage of, and expand access to, home and community-based services under the Medicaid program, to award grants for the creation, recruitment, training and education, retention, and advancement of the direct care workforce and to award grants to support family caregivers, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.765 – A bill to amend title XVIII of the Social Security Act to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would reduce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Finance

 

S.767 – A bill to enhance mental health and psychosocial support within United States development and humanitarian assistance programs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Foreign Relations

 

H.Res.214 – Supporting the goals and ideals of “Deep Vein Thrombosis and Pulmonary Embolism Awareness Month”; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce

 

H.Res.217 – Supporting the designation of March 2023 as Endometriosis Awareness Month; Sponsor: Scott, David [Rep.- D-GA-13]; Committees: House – Energy and Commerce

 

H.R.1485 – To limit the price charged by manufacturers for insulin; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce

 

H.R.1488 – To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes; Sponsor: Craig, Angie [Rep.-D-MN-2]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.1493 – To amend title XIX of the Social Security Act to require coverage of, and expand access to, home and community-based services under the Medicaid program; to award grants for the creation, recruitment, training and education, retention, and advancement of the direct care workforce and to award grants to support family caregivers; and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Education and the Workforce; Oversight and Accountability

 

H.R.1502 – To amend title V of the Public Health Service Act to reauthorize comprehensive opioid recovery centers, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce

 

H.R.1503 – To provide for digital communication of prescribing information for drugs (including biological products), and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.1512 – To allow women to greater access to a wider range of self-administered contraceptives approved under the Federal Food, Drug, and Cosmetic Act; Sponsor: Mace, Nancy [Rep.-R-SC-1]; Committees: House – Energy and Commerce

 

H.R.1523 – To amend title XIX of the Social Security Act to reduce Federal financial participation for certain States that require political subdivisions to contribute towards the non-Federal share of Medicaid; Sponsor: Tenney, Claudia [Rep.-R- NY-24]; Committees: House – Energy and Commerce

 

H.R.1526 – To amend title XVIII of the Social Security Act to provide hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, and to provide coverage of certain cancer screenings or preventive surgeries that would reduce the risk for individuals with a germline (inherited) mutation associated with a high risk of developing a preventable cancer; Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]; Committees: House – Energy and Commerce; Ways and Means’

The Senate voted unanimously last week to require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic. Passage of the COVID-19 Origin Act (S. 619) follows a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray separately acknowledged on Tuesday the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan.

 

HELP Leadership Seek Information on Health Care Workforce Shortages

Senate Health, Education, Labor, and Pensions Committee (HELP) Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have sent a letter to health care stakeholders requesting input on the drivers of current health care workforce shortages and possible legislative solutions to the problem. HELP Committee leadership have repeatedly stated their intent to prioritize health care worker shortages as an area of bipartisan compromise, with the panel holding its first hearing of the 118th Congress on the subject last month. The letter states their plan to use the information received to draft bipartisan legislation to strengthen workforce capacity. Sanders and Cassidy request responses be sent to HealthWorkforceComments @help.senate.gov no later than Monday, March 20.

 

Hudson, Eshoo Release RFI on PAHPA Reauthorization

House Energy and Commerce Committee members Reps. Richard Hudson (R-N.C.) and Anna Eshoo (D-Calif.) have released a request for information (RFI) on improving the nation’s biosecurity and preparedness infrastructure. The RFI comes as the lawmakers begin work to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA). Current authority for the program expires on September 30. “As I lead the process with my colleague, Rep. Eshoo, to improve our preparedness, I am seeking feedback and suggestions on how our country can be better prepared, further equipped, more transparent, and fully accountable when taking on future emergencies,” Rep. Hudson stated. Responses to the RFI are due by Monday, March 13.

 

Ways and Means Republicans Release Oversight Priorities

House Committee on Ways and Means Chair Jason Smith (R-Mo.) released his priorities for oversight hearings and related activities that the committee and its subcommittees plan to conduct over the course of the 118th Congress. Matters under the committee’s health care jurisdiction include oversight of the No Surprises Act implementation, oversight of the implementation of prescription drug provisions in the Inflation Reduction Act, adequacy and appropriateness of Medicare provider reimbursements, oversight of graduate medical education policies, and oversight of existing and proposed health care price transparency requirements. The plan also highlights concerns related to the delivery of health services and Medicare reimbursement.

 

Oversight Panel Launches Investigation into Role of PBMs

The House Committee on Oversight and Accountability has launched an investigation into the business practices of pharmacy benefit managers (PBMs) and their impact on patients, the nation’s pharmaceutical market, and overall health care costs. “Pharmacy benefit managers’ anticompetitive tactics are driving up health care costs for Americans and harming patient care,” Chair James Comer (R-Ky.) stated. “Federal agencies administering health care programs for seniors, active-duty military, and federal employees rely on PBMs as middlemen to set drug prices, which opens the door to government waste at the expense of American taxpayers.” Comer has requested information from the Office of Personnel Management, Centers for Medicare and Medicaid Services, and the Defense Health Agency on how government- administered health programs are affected by PBMs. He has also requested information from the nation’s three largest PBMs – Express Scripts, CVS Caremark, and OptumRx, about their business practices, including details on the total rebates and fees collected by the companies.

 

Bipartisan Bill Reintroduced to Encourage Prescription Drug Competition

On March 1, Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, reintroduced the Prescription Drug Competition Act (S. 574). The Food and Drug Administration (FDA) may require drug manufacturers to have a Risk Evaluation and Mitigation Strategy (REMS) program to ensure the benefits of a drug with potential safety concerns outweigh the risks. However, as reported in the New York Times, drug manufacturers may patent their respective REMS programs and then leverage those patents to prevent alternative medications from entering the market. To address this, S. 574 would allow FDA to approve a generic medication immediately (avoiding the current 30-month stay) if the only impediment in the approval process is the reference product’s REMS patent. The legislation also includes provisions that would allow the continued sale of a generic medication facing litigation over a REMS patent. The legislation has been referred to the Senate HELP Committee.

 

POLICY BRIEFINGS

 

Lawmakers React to Elli Lilly’s Insulin Pricing Announcement

Eli Lilly announced last week that it will reduce the list price of its insulin products and cap patients’ out-of-pocket costs at $35 a month. The move was praised by Sen. Patty Murray (D-Wash.) who characterized it as “a critical step forward” but “long overdue.” Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) subsequently sent letters to Sanofi and Novo Nordisk calling on the companies to lower the prices of their insulin products as well. He also previewed plans to introduce legislation to cap insulin costs at $20 per vial.

 

E&C Republicans Express Opposition to 2024 NBPP

Republican leadership of the House Committee on Energy and Commerce have sent a letter to the Biden administration expressing concerns with the 2024 Notice of Benefit and Payment Parameters (NBPP), which proposes to limit the number of plans that an issuer may offer in the Affordable Care Act marketplace that do not meet certain specifications. The U.S. Department of Health and Human Services estimates that the proposed regulation could result in the termination of 57% of plans on the federal platform – ultimately impacting 2.7 million Americans. “Despite once declaring that, ‘excessive market concentration threatens basic economic liberties,’ President Biden wants to drastically limit Americans’ choices in the health insurance market. In fact, under his latest rule, more than half of all Obamacare plans on the federal exchange would disappear,” the letter states. The lawmakers urge the administration to immediately abandon the proposal and advance policies that “discourage provider consolidation or improve transparency of health care prices to empower individuals and employers when purchasing health care.” The letter was signed by Committee Chair Cathy McMorris Rodgers (R-Wash.), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.), and Subcommittee on Health Chair Brett Guthrie (R-Ky.).

 

Ohio Senators Urge Health Surveys in East Palestine

Sens. Sherrod Brown (D-Ohio) and J.D. Vance (R-Ohio) have sent a letter to the Centers for Disease Control and Prevention and the Environmental Protection Agency urging the administration to undertake both immediate and long-term health surveys of individuals residing near the recent train derailment in East Palestine as soon as possible. The lawmakers argue that such surveys and assessments are needed to establish a medical baseline for the community exposed to the hazardous chemicals released in the derailment. “The residents of East Palestine and the surrounding community deserve to know if their health has been compromised by this disaster now and for years to come,” the letter states. “Therefore, we urge you to work with your colleagues across the federal government to allocate the resources and expertise needed to begin the surveys and assessment needed to establish a medical baseline for the community.”

 

FY 2024 Appropriations Update

Senate appropriations leadership announced plans to begin marking up fiscal year (FY) 2024 appropriations bills in May. Chair Patty Murray (D-Wash.) and Ranking Member Susan Collins (R-Maine) told panel members that they are currently negotiating a topline spending target that can be used in drafting the 12 annual spending bills. The Senate Appropriations Committee did not mark up any FY 2023 appropriations legislation last year.

House Appropriations Labor-Health and Human Services-Education Subcommittee Chair Robert Aderholt (R-Ala.) has decided to ban congressionally directed spending requests – or earmarks – from his panel’s FY 2024 appropriations bill. Many conservative members in the House of Representatives have expressed support for an across-the-board ban on earmarks in annual funding bills. Bans on earmark requests will also be applied to the Financial Services and Defense bills. House Appropriations Committee Chair Kay Granger (R-Texas) has indicated that Republicans will otherwise maintain the cap on earmarks at 15 per member, while also emphasizing that only those projects with a direct tie to the federal government will be considered for funding.

 

Senate Works to Advance Health Nominees

The Senate Finance Committee advanced President Joe Biden’s nomination of Rebecca Haffajee to serve as U.S. Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) last week over objections from panel Republicans in a 14-12 vote. Haffajee, an attorney and public health researcher, currently serves as ASPE’s principal deputy assistant secretary. Her nomination will now be sent to the full Senate for a vote. Senate Majority Leader Chuck Schumer (D-N.Y.) has also filed a procedural motion to limit debate and consider the nomination of Patrice Kunesh to serve as commissioner of the Administration for Native Americans at HHS.

 

Feinstein Hospitalized with Shingles

Sen. Dianne Feinstein (D-Calif.) has been hospitalized in San Francisco with a case of shingles after being diagnosed with the infection over the February recess. The Senate’s oldest member stated that she expects to make a full recovery and return to the chamber later this month. Feinstein adds to several health-related absences among Democrats in the Senate, who hold a narrow 51-49 seat majority, that could complicate the advancement of President Joe Biden’s judicial nominees. Feinstein is a member of the Senate Judiciary Committee, where Democrats hold a one-seat majority. Sen. John Fetterman (D-Pa.) remains in treatment for depression, and his office has not provided a timeframe for his return.

 

Rep. Castro Treated for Cancer

Rep. Joaquin Castro (D-Texas) will be absent from the House of Representatives for several weeks after undergoing surgery to remove cancerous tumors in his gastrointestinal tract. Castro stated that the “small, slow-growing, and mostly asymptomatic” gastrointestinal neuroendocrine tumors were discovered last summer following a series of tests, and that his overall prognosis is good. He plans to remain at home recovering for “several weeks” before returning to Washington.

 

Slotkin to Run for Senate

Rep. Elissa Slotkin (D-Mich.) announced last week that she will run to fill the seat of retiring Sen. Debbie Stabenow (D-Mich.) in 2024. Slotkin was first elected to the House of Representatives in 2018 after serving three tours in Iraq as an analyst for the Central Intelligence Agency. She currently serves on the House Armed Services and Agriculture committees.

 

FDA Panel Recommends Approval of RSV Vaccines

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted last week to recommend that the Food and Drug Administration (FDA) approve both Pfizer’s and GlaxoSmithKline’s (GSK) respiratory syncytial virus (RSV) vaccines. VRBPAC voted 7-4 with one abstention in support of the safety of Pfizer’s vaccine, and 7-4 with one abstention in support of the efficacy of Pfizer’s vaccine. Support for GSK’s product was wider – the panel voted 10-2 in support of its safety and were unanimous in support of its efficacy. Some panel members expressed concerns about the possibility of nervous system disorders like Guillain-Barré syndrome associated with the vaccines. If the vaccines are approved by the FDA, they will then be considered before the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for recommendations on how and when the vaccines are to be used.

 

New Survey Released on Telemedicine Use, Preferences

Most U.S. adults prefer getting prescription refills and care for minor illnesses via telemedicine rather than in-person care, according to a new survey released by Rock Health and Stanford University’s Center for Digital Health. The survey of more than 8,000 adults found that approximately two-thirds of Americans prefer in-person care for visits related to chronic conditions and mental health, while three-quarters of adults prefer in-person visits for annual wellness checks, emergency care, and physical therapy. The survey also covered the differences in rates of telemedicine use among different populations before and after the start of the coronavirus pandemic, finding telemedicine use grew especially among uninsured and rural respondents.

 

Upcoming Congressional Hearings and Markups

 

Senate Appropriations Subcommittee on Department of Defense meeting to receive a briefing on the Department of Defense Health Program; 10:00 a.m.; March 7

 

House Veterans Affairs Committee hearing “Veterans Health Information Systems and Technology Architecture (VistA);” 3:00 p.m.; March 7

 

House Intelligence Committee markup of H.R. 1376, COVID-19 Origins Act of 2023; 5:00 p.m.; March 7

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Origins of COVID-19;” 9:00 a.m.; March 8

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies Member Day Hearing; 10:00 a.m.; March 8

 

Senate Homeland Security & Governmental Affairs Committee hearing “Artificial Intelligence: Risks and Opportunities;” 10:00 a.m.; March 8

 

House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet hearing “Intellectual Property and Strategic Competition with China: Part I;” 10:00 a.m.; March 8

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation hearing “Advances in AI: Are We Ready for a Tech Revolution?” 2:00 p.m.; March 8

 

Senate Environment and Public Works Committee hearing to examine protecting public health and the environment in the wake of the Norfolk Southern train derailment and chemical release in East Palestine, Ohio; 10:00 a.m.; March 9

 

Senate Special Committee on Aging hearing “Uplifting Families, Workers, and Older Adults: Supporting Communities of Care;” 10:30 a.m.; March 9

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

 

H.R.1191 – To amend title 38, United States Code, to expand eligibility for a presumption of service connection for diseases associated with exposure to certain herbicide agents for certain veterans who served in Guam; Sponsor: Moylan, James C. [Del.-R-GU-At Large]; Committees: House – Veterans’ Affairs

 

H.R.1182 – To amend the VA Choice and Quality Employment Act to direct the Secretary of Veterans Affairs to establish a vacancy and recruitment database to facilitate the recruitment of certain members of the Armed Forces to satisfy the occupational needs of the Department of Veterans Affairs, to establish and implement a training and certification program for intermediate care technicians in that Department, and for other purposes; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Veterans’ Affairs

 

H.R.1173 – To amend the Federal Food, Drug, and Cosmetic Act regarding the patient medication information required to be included in the labeling of prescription drugs, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R- GA-1]; Committees: House – Energy and Commerce

 

H.R.1170 – To amend the Internal Revenue Code of 1986 to clarify that expenses for blood storage qualify as expenses for medical care; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Ways and Means

 

H.R.1166 – To enhance authorities under the Defense Production Act of 1950 to respond to the public health emergencies, to provide additional oversight of such authorities, and for other purposes; Sponsor: Vargas, Juan [Rep.-D- CA-52]; Committees: House – Financial Services

 

H.R.1154 – To combat forced organ harvesting and trafficking in persons for purposes of the removal of organs, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Foreign Affairs; Judiciary

 

S.Res.85 – A resolution designating March 1, 2023, as “National Assistive Technology Awareness Day”. Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.84 – A resolution designating February 28, 2023, as “Rare Disease Day”. Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.81 – A resolution relating to the establishment of a means for the Senate to provide advice and consent regarding the form of an international agreement relating to pandemic prevention, preparedness, and response. Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Foreign Relations

 

S.Res.79 – A resolution expressing support for the designation of February 26, 2023, to March 4, 2023, as “National Fentanyl Awareness Week” and raising awareness of the negative impacts of fentanyl in the United States; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Judiciary

 

S.570 – A bill to amend title XIX of the Social Security Act to improve coverage of dental and oral health services for adults under Medicaid, and for other purposes. Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

 

S.569 – A bill to amend title XXXIII of the Public Health Service Act with respect to flexibility and funding for the World Trade Center Health Program. Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.565 – A bill to require the Secretary of Health and Human Services to award grants to pregnancy-help organizations. Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.543 – A bill to increase research, education, and treatment for cerebral cavernous malformations. Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.186 – Expressing the sense of the House of Representatives that the People’s Republic of China should be held accountable for its handling of COVID-19. Sponsor: Mast, Brian J. [Rep.-R-FL-21]; Committees: House – Foreign Affairs

 

H.Res.185 – Declaring racism a public health crisis. Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Energy and Commerce; Judiciary

 

H.Res.181 – Expressing support for the designation of February 28, 2023, as “Rare Disease Day”. Sponsor: Carson, Andre [Rep.-D-IN-7]; Committees: House – Energy and Commerce

 

H.Res.178 – Affirming the House of Representatives’ commitment to protect and strengthen Social Security and Medicare. Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Ways and Means; Energy and Commerce

 

H.Res.175 – Recognizing the rise of cardiovascular disease as the world’s leading cause of preventable death and disability and as the global public health crisis of this generation and supporting the recognition of February 2023 as “American Heart Month”; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce

 

H.Res.172 – Expressing support for designation of March 3, 2023, as “National Triple-Negative Breast Cancer Day”; Sponsor: Morelle, Joseph D. [Rep.-D-NY-25]; Committees: House – Oversight and Accountability

 

H.Res.170 – Recognizing it is the congressional intent of the Affordable Care Act that enhanced Federal medical assistance percentage funds are to be directly shared with the counties in States with a Medicaid local share requirement; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.1199 – To amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system; Sponsor: Dunn, Neal P. [Rep.-R-FL-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1201 – To amend title XIX of the Social Security Act to remove the exclusion from medical assistance under the Medicaid Program of items and services for patients in an institution for mental diseases, and for other purposes; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.1202 – To amend the Higher Education Act of 1965 to provide for interest-free deferment on student loans for borrowers serving in a medical or dental internship or residency program; Sponsor: Babin, Brian [Rep.-R-TX-36]; Committees: House – Education and the Workforce

 

H.R.1210 – To amend the Public Health Service Act to provide the Secretary of Health and Human Services with the authority to suspend the right to introduce certain persons or property into the United States in the interest of the public health; Sponsor: DesJarlais, Scott [Rep.-R-TN-4]; Committees: House – Energy and Commerce

 

H.R.1215 – To amend the Internal Revenue Code of 1986 to establish a refundable healthcare worker tax credit with semiannual advance payment; Sponsor: Magaziner, Seth [Rep.-D-RI-2]; Committees: House – Ways and Means

 

H.R.1224 – To amend the Public Health Service Act to provide for a national public awareness campaign to inform health care professionals and health care professional students on how to help patients navigate the legal landscape in the United States with respect to abortion and other reproductive health care services following the Supreme Court’s decision to overturn Roe v. Wade, and for other purposes; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Energy and Commerce

 

H.R.1264 – To streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1256 – To amend title 38, United States Code, to make certain improvements in the laws relating to the appointment of the Under Secretary of Health and Assistant Under Secretaries of Health of the Department of Veterans Affairs, and for other purposes. Sponsor: Mrvan, Frank J. [Rep.-D-IN-1]; Committees: House – Veterans’ Affairs

 

S.Res.90 – A resolution recognizing the significance of endometriosis as an unmet chronic disease for women and designating March 2023 as “Endometriosis Awareness Month”; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Judiciary

 

S.574 – A bill to amend the Federal Food, Drug, and Cosmetic Act to prevent the use of patents, trade secrets, or other intellectual property to inhibit competition; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.592 – A bill to amend title 38, United States Code, to increase the mileage rate offered by the Department of Veterans Affairs through their Beneficiary Travel program for health related travel, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.600 – A bill to amend the Controlled Substance Act to list fentanyl-related substances as schedule I controlled substances; Sponsor: Johnson, Ron [Sen.-R-WI]; Committees: Senate – Judiciary

 

S.603 – A bill to establish procedures regarding the approval of opioid drugs by the Food and Drug Administration; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.604 – A bill to direct the Secretary of Health and Human Services to amend the mission statement of the Food and Drug Administration; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.606 – A bill to require the Food and Drug Administration to revoke the approval of one opioid pain medication for each new opioid medication approved; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.607 – A bill to allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.614 – A bill to codify the temporary scheduling order for fentanyl-related substances by adding fentanyl-related substances to schedule I of the Controlled Substances Act; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Judiciary

 

H.Res.193 – Expressing support for the goals and ideals of “World Hearing Day”; Sponsor: Thompson, Mike [Rep.-D- CA-4]; Committees: House – Energy and Commerce

 

H.R.1276 – To protect children from medical malpractice in the form of gender transition procedures; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Energy and Commerce; Judiciary; Education and the Workforce; Natural Resources; Ways and Means

 

H.R.1280 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research related to cerebral palsy, and for other purposes; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

 

H.R.1291 – To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances; Sponsor: Fitzgerald, Scott [Rep.-R-WI-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1294 – To amend title XXXIII of the Public Health Service Act with respect to flexibility and funding for the World Trade Center Health Program; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Energy and Commerce

 

H.R.1305 – To direct the Secretary of Health and Human Services, in consultation with the Secretary of State, to formulate a strategy for the Federal Government to secure support from foreign countries, multilateral organizations, and other appropriate entities to facilitate the development and commercialization of qualified pandemic or epidemic products, and for other purposes; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Foreign Affairs

 

H.R.1315 – To amend the Public Health Service Act to establish a Prostate Cancer Coordinating Committee, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce

 

H.R.1316 – To amend titles XIX and XXI of the Social Security Act to allow States to provide for extended periods of continuous coverage under the Medicaid and CHIP programs for children, to provide a period of continuous eligibility under the Medicaid program for certain adults, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.1326 – To modify the limitation on the deduction by individuals of certain State and local taxes and to provide coverage for hearing and vision care under the Medicare program; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1328 – To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

S.624 – A bill to amend title X of the Public Health Service Act to prohibit family planning grants from being awarded to any entity that performs abortions, and for other purposes; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.626 – A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.628 – A bill to amend the Internal Revenue Code of 1986 to provide for the treatment of direct primary care service arrangements as medical care, to provide that such arrangements do not disqualify deductible health savings account contributions, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

S.631 – A bill to protect the privacy of personally-identifiable health and location data, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Commerce, Science, and Transportation

 

S.635 – A bill to protect children from medical malpractice in the form of gender transition procedures; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Judiciary

 

S.641 – A bill to terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers, and for other purposes; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.642 – A bill to facilitate the development of treatments for cancers, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

S.644 – A bill to expand the take-home prescribing of methadone through pharmacies; Sponsor: Markey, Edward J. [Sen.- D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.652 – A bill to amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Health, Education, Labor, and Pensions

The Drug Enforcement Administration (DEA) has released a proposed rule to reinstate requirements that a patient see a doctor in-person before being prescribed certain controlled substances like Adderall and Oxycontin. These requirements had been waived for the duration of the COVID-19 pandemic. Providers would be permitted to prescribe an initial 30-day supply of buprenorphine for opioid use disorder, testosterone for gender affirming care, and ketamine for depression, but patients would then need to visit the provider in-person to continue their medications. Patients who began a covered medication during the pandemic would be given a 180-day grace period to comply with the in-person visit requirements. If finalized, the new regulation would go into effect when the COVID-19 public health emergency ends on May 11. The proposed rule will be open for public comment for 30 days.

 

GOP Health Leaders Request Transparency on Medicare Drug Negotiation Implementation

Republican health committee leaders have sent a letter to the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services regarding the $3 billion fund created by the Inflation Reduction Act for the implementation of new drug pricing measures. “We write to request information and regular updates on how the Biden administration plans to allocate, apply, and monitor this staggering sum moving forward,” the letter states. “By sidestepping regular order and bypassing the standard appropriations process, proponents of the IRA set aside billions in taxpayer dollars with no reporting requirements or tools to prevent waste, fraud, and abuse.” The lawmakers request updates on projected spending over the next decade so that Congress can appropriately adjust the IRA’s statutory spending level. The letter was signed by Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), and House Ways and Means Committee Chair Jason Smith (R-Mo.). They request a response from the administration by March 24.

 

Bilirakis, Tonko Launch Longevity Science Caucus

Reps. Gus Bilirakis (R-Fla.) and Paul Tonko (D-N.Y.) announced their formation of the Longevity Science Caucus last week. The group will work to promote aging technology and research in response to the decline in the nation’s life expectancy and to “support science and research that will enable people to live fuller and healthier lives.” Caucus membership includes Reps. Michael Burgess (R-Texas), Dan Crenshaw (R-Texas), and Anna Eshoo (D-Calif.), all members of the House Energy and Commerce Committee.

 

McClellan Sworn-In to House of Representatives; Lee and Cicilline Announce Future Plans

Rep. Jennifer McClellan (D-Va.) was sworn in as a member of the House of Representatives last week. She was elected to fill the only vacant seat in Congress. She succeeds the late Donald McEachin (D), who passed away in late November 2022. McClellan is an attorney and a 17-year state legislator. Her campaign for the House seat focused on expanding access to health care and protecting voting rights, the environment, and abortion services. She is the first Black woman to be elected to Congress from the state of Virginia.

Rep. Barbara Lee (D-Calif.) announced that she is joining the race to fill the Senate seat being vacated by Sen. Dianne Feinstein in 2024. Lee, a member of the House Appropriations and Budget committees, joins Reps. Katie Porter (D-Calif.) and Adam Schiff (D-Calif.) in running for Feinstein’s seat. Rep. David Cicilline (D-R.I.) announced that he will retire from the House of Representatives on June 1. Cicilline plans to become head of the Rhode Island Foundation. He currently serves as a member of the Judiciary Committee and Foreign Affairs Committee.

 

Warren Leads Letter on Keytruda Patents

Sen. Elizabeth Warren (D-Mass.) has sent a letter to the U.S. Patent and Trademark Office (USPTO) asking the agency to investigate Merck & Co.’s requests for new patents on its cancer treatment Keytruda. Merck is looking to patent a new self-injectable form of the drug. Warren expresses concerns that the company may be trying to use the patent system to prevent competition and urges USPTO Director Kathi Vidal to reject any requests that do not clearly meet the agency’s standards of novelty, utility, and non-obviousness. “Should the USPTO approve new patent applications for the drug, biosimilar competitors could be shut out of the market until 2036, giving Merck a total period of nearly 35 years of patent protection for Keytruda,” Warren argues. The letter was cosigned by Sen. Bernie Sanders (I-Vt.) and Reps. Katie Porter (D-Calif.) and Pramila Jayapal (D-Wash.).

 

Democrats Urge Administration to Address “Junk” Health Plans

Agroup of Senate Democrats have sent a letter to HHS Secretary Xavier Becerra asking the administration to take immediate action to address the availability of short-term, limited duration health insurance plans that violate the Affordable Care Act. The letter expresses concerns about individuals who will lose Medicaid coverage gained during the COVID-19 pandemic as state programs begin their redetermination processes. Without additional protections, “many Americans could find themselves enrolled in junk plans that do not provide comprehensive coverage or protection for individuals with pre-existing conditions,” the letter states. “It is past time for your department to step up and address the expansion and proliferation of junk plans.”

 

Wyden, Warren Request Info on McKinsey Hospital Guidance

Sens. Ron Wyden (D-Ore.) and Elizabeth Warren (D-Mass.) have sent a letter to McKinsey & Co. criticizing the consulting firm’s guidance to nonprofit hospitals, which they argue would take financial advantage of low-income patients. A recent report from the New York Times found that McKinsey was paid $45 million by non-profit hospital Providence Health to create a plan to use predatory tactics to pressure patients into paying for their care, no matter their income or ability to pay. “We write to seek a greater understanding of the full scope of McKinsey’s partnerships with nonprofit hospitals and the extent to which vulnerable patients may be exploited by them,” the lawmakers state.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

 
House Veterans’ Affairs Committee hearing “Building an Accountable VA: Applying Lessons Learned to Drive Future Success;” 2:00 p.m.; February 28

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Promoting U.S. Innovation and Individual Liberty through a National Standard for Data Privacy;” 8:30 a.m.; March 1

 

Senate Health, Education, Labor, and Pensions Committee hearing “Community Health Centers: Saving Lives, Saving Money;” 10:00 a.m.; March 2

 

House Veterans Affairs Committee hearing “Veterans Health Information Systems and Technology Architecture (VistA);” 3:00 p.m.; March 7

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

 

H.R.1092 – To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.1090 – To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.1089 – To require directors of medical centers of the Department of Veterans Affairs to submit annual fact sheets to the Secretary of Veterans Affairs on the status of such facilities, and for other purposes; Sponsor: Lesko, Debbie [Rep.-R- AZ-8]; Committees: House – Veterans’ Affairs

 

H.R.1080 – To provide for the reinstatement or compensation of Federal employees forced to resign their careers between September 9, 2021, and January 24, 2022, because of the Federal COVID-19 vaccination mandate, and for other purposes; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Oversight and Accountability; Ways and Means

 

H.R.1079 – To amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Energy and Commerce

 

H.R.1074 – To amend title XIX of the Social Security Act to allow for greater State flexibility with respect to excluding providers who are involved in abortions; Sponsor: Cloud, Michael [Rep.-R-TX-27]; Committees: House – Energy and Commerce

 

H.R.1072 – To amend the Public Health Service Act to authorize supplemental awards to health centers to establish community transformation hubs; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.1066 – To require the Secretary of Health and Human Services to issue and disseminate guidance to States to clarify strategies to address social determinants of health under the Medicaid program and the Children’s Health Insurance Program, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.1110 – To direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and Children’s Health Insurance programs during the COVID-19 emergency; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1113 – To streamline enrollment in health insurance affordability programs and minimum essential coverage, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1114 – To provide for optimized care, a coordinated Federal Government response, public education, and insurance reimbursement guidance for Long COVID, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.1117 – To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.1126 – To make improvements in prenatal and maternal care, and for other purposes; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce

 

H.R.1128 – To amend title XVIII of the Social Security Act to permit States to designate without any mileage limitations facilities that are located in rural areas as critical access hospitals; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Ways and Means

 

H.R.1129 – To direct the Secretary of Health and Human Services to revise regulations to remove the requirement under the Medicare program that an off-campus facility or organization shall be located within a 35-mile radius of a hospital or critical access hospital; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1144 – To direct the Secretary of Veterans Affairs to develop a strategy for telehealth furnished by the Veterans Health Administration and submit a report on end-user devices distributed by the Secretary to veterans to facilitate such telehealth; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Veterans’ Affairs

Former President Jimmy Carter, 98, has begun receiving hospice care following a series of short hospital stays, according to The Carter Center. He has opted to forgo additional medical intervention in favor of spending his remaining time at home with his family, according to the statement from the center. Carter served as the 39th president of the United States from 1977 to 1981. He is the nation’s oldest living President and the nation’s longest-lived president.

 

Senate Appropriations Announces Subcommittee Rosters

Senate Appropriations Committee Chair Patty Murray (D-Wash.) and Ranking Member Susan Collins (R-Maine) have announced their panel’s subcommittee chairs, ranking members, and full rosters for the 118th Congress. Sen. Martin Heinrich (D-N.M.) and Sen. John Hoeven (R-N.D.) will serve as chair and ranking member of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee. Sen. Tammy Baldwin (D-Wis.) and Sen. Shelley Moore Capito (R-W.Va.) will serve as chair and ranking member of the Labor, Health and Human Services, Education, and Related Agencies Subcommittee. The full details on subcommittee leadership and rosters can be found here. Hart Health Strategies Inc. continues to update our Guide to the 118th Congress. This living document provides a list of health professionals serving in Congress, House and Senate leadership, congressional health committee members, and biographies on new members of Congress.

 

Coronavirus Panel Jumpstarts COVID-19 Origins Investigation

Republicans on the House Select Subcommittee on the Coronavirus Pandemic are requesting testimony, classified briefings, and documents from current Biden administration officials, U.S. intelligence agencies, and Anthony Fauci regarding the origins of the COVID-19 pandemic. The lawmakers are looking to further delve into theories that the coronavirus originated from laboratory experiments and gain-of-function research – possibly funded by U.S. dollars – in Wuhan, China, rather than from a Chinese market as much evidence indicates. Letters requesting information were sent to U.S. Department of Health and Human Services Secretary Xavier Becerra, former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, EcoHealth Alliance President Peter Daszak, Director of National Intelligence Avril Haines, and White House adviser Francis Collins. Fauci has repeatedly stated that he would be willing to testify before any congressional committee if asked.

 

New GAO Report on Private Equity and IRB Effectiveness

The Government Accountability Office (GAO) released a new report last week regarding private equity consolidation of institutional review boards (IRBs). The report came at the request of Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-Vt.) and Sens. Elizabeth Warren (D-Mass.) and Sherrod Brown (D-Ohio) due to concerns about the increased use of independent IRBs and the effect on protecting human subjects. The GAO makes four recommendations to improve federal oversight of IRBs, including that the U.S. Department of Health and Human Services and the Food and Drug Administration conduct annual risk assessments to determine if the agencies are routinely inspecting an adequate number of IRBs and to optimize the use of inspections in the oversight of IRBs and protection of research participants. GAO also suggests that agencies examine and implement approaches for measuring IRB effectiveness.

 

Feinstein Announces Retirement Decision

Sen. Dianne Feinstein (D-Calif.) announced her decision to not run for a seventh Senate term in 2024. Feinstein, 89, is the chamber’s longest serving Democrat and its oldest member. Her decision to retire was widely expected, with Reps. Katie Porter (D-Calif.) and Adam Schiff (D-Calif.) having previously announced bids for her seat in the Senate. Feinstein is currently a member of the Senate Judiciary Committee and the Appropriations Committee.

 

POLICY BRIEFINGS

Fetterman Seeks Treatment for Depression

Sen. John Fetterman (D-Pa.), 53, announced last week that he has checked himself into inpatient treatment at Walter Reed Medical Center and is seeking treatment for clinical depression on the recommendation of Congress’ attending physician. Fetterman is also in recovery from a stroke suffered on the campaign trail last year. According to the American Stroke Association, depression is common among stroke survivors. Fetterman’s aides have stated that he will likely return to the Senate from inpatient care in a few weeks.

 

Casey Undergoes Surgery for Prostate Cancer

Sen. Bob Casey (D-Pa.) underwent a scheduled surgery for prostate cancer last week and plans to return to the Senate “after a period of rest and recovery.” Doctors do not expect him to require further treatment, according to a tweet from the Senator’s office. While the chamber is not scheduled to reconvene until February 27, an extended absence from Casey, along with the absence of Sen. John Fetterman (D-Pa.), could have an impact on Senate business given Democrat’s slim 51-49 majority.

 

CBO Describes Scoring Methodology Behind Reconciliation Bill’s Drug Pricing Measures

The Congressional Budget Office (CBO) has released a presentation describing how the agency estimated the budgetary impact of the major prescription drug pricing provisions of the Inflation Reduction Act, passed last year via the budget reconciliation process. The law requires the U.S. Department of Health and Human Services to negotiate the prices of certain Medicare Part B and Part D drugs, requires pharmaceutical manufacturers of brand products to pay rebates if their prices exceed an inflation-adjusted benchmark, and provides for redesigns of the Part D benefit. In total, CBO estimated that these measures will reduce the federal deficit by $129 billion from 2022 through 2031.

 

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

H.R.982 – To address the health needs of incarcerated women related to pregnancy and childbirth, and for other purposes. Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Judiciary; Budget

 

H.R.977 – To repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals. Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.974 – To remove obstacles to the ability of law enforcement officers to enforce gun safety laws, and for other purposes. Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Judiciary

H.Res.122 – Expressing support for States to expand Medicaid under the Affordable Care Act to close the Medicaid coverage gap. Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Energy and Commerce

 

S. 397 – A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans; Sponsor: Brown, Sherrod [D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.403 – A bill to amend the Public Health Service Act to authorize a public education campaign across all relevant programs of the Health Resources and Services Administration to increase oral health literacy and awareness; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.406 – A bill to establish the Public Health Information and Communications Advisory Committee for purposes of providing recommendations and reports, and to support educational initiatives on communication and dissemination of information during public health emergencies; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.407 – A bill to amend title XIX of the Social Security Act to establish a methodology for determining State allotments for Medicaid disproportionate share hospital payments that is based on State poverty levels, to require States to prioritize disproportionate share hospital payments on the basis of Medicaid inpatient utilization and low-income utilization rates, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

S.420 – A bill to prohibit Federal funds from being made available to facilities that refuse to provide treatment based on COVID-19 vaccination status; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.421 – A bill to prohibit Federal funding to the Wuhan Institute of Virology and to require a GAO study regarding Federal funds previously provided to such institute or to entities affiliated with the Chinese Government; Sponsor: Ernst, Joni [Sen.-R-IA]; Committees: Senate – Foreign Relations

 

S.423 – A bill to streamline enrollment in health insurance affordability programs and minimum essential coverage, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Finance

 

S.424 – A bill to protect the seniors of the United States, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

 

Recently Introduced Health Legislation -cntd

H.R.990 -To amend title XIX of the Social Security Act to establish a methodology for determining State allotments for Medicaid disproportionate share hospital payments that is based on State poverty levels, to require States to prioritize disproportionate share hospital payments on the basis of Medicaid inpatient utilization and low-income utilization rates, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.991 – To prohibit Federal funds from being made available to entities that refuse to provide treatment based on COVID-19 vaccination status; Sponsor: Bishop, Dan [Rep.-R-NC-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.994 – To amend the Public Health Service Act to authorize a public education campaign across all relevant programs of the Health Resources and Services Administration to increase oral health literacy and awareness; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce

 

H.R.1001 – To amend the Higher Education Act of 1965 to include service as a veteran family caregiver as a public service job for purposes of the public service loan forgiveness program, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Education and the Workforce

 

H.R.1003 -To direct the Secretary of Veterans Affairs to carry out a study and clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other purposes; Sponsor: Correa, J. Luis [Rep.-D-CA-46]; Committees: House – Veterans’ Affairs

 

H.R.1004 – To establish the Public Health Information and Communications Advisory Committee for purposes of providing recommendations and reports, and to support educational initiatives on communication and dissemination of information during public health emergencies; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce

 

H.R.1011 -To require the Director of the Office of Management and Budget to conduct an audit of any unobligated coronavirus-related funding and to rescind all such funding, and for other purposes; Sponsor: Finstad, Brad [Rep.-RMN-1]; Committees: House – Oversight and Accountability; Appropriations

 

H.R.1012 -To amend the Public Health Service Act to clarify liability protections regarding emergency use of automated external defibrillators; Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Energy and Commerce

 

H.R.1024 – To amend the Public Health Service Act to ensure that nonanimal methods are prioritized, where applicable and feasible, in proposals for all research to be conducted or supported by the National Institutes of Health, to provide for the establishment of the National Center for Alternatives to Animals in Research and Testing, and for other purposes; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce

 

H.R.1025 – To prohibit Federal funding to the Wuhan Institute of Virology and to require a GAO study regarding Federal funds previously provided to such institute or to entities affiliated with the Chinese Government; Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Foreign Affairs

 

H.R.1029 – To amend titles XVIII and XIX of the Social Security Act to make improvements to the treatment of the United States territories under the Medicare and Medicaid programs, and for other purposes; Sponsor: Plaskett, Stacey E. [Del.-D-VI-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

S.444 – A bill to require any convention, agreement, or other international instrument on pandemic prevention, preparedness, and response reached by the World Health Assembly to be subject to Senate ratification; Sponsor: Johnson, Ron [Sen.-R-WI]; Committees: Senate – Foreign Relations

 

S.449 – A bill to amend title 38, United States Code, to improve the assignment of patient advocates at medical facilities of the Department of Veterans Affairs; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.455 – A bill to terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.456 – A bill to amend title 10, United States Code, to authorize non-medical counseling services, provided by certain mental health professionals, to military families; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Armed Services

 

S.457 – A bill to establish a Federal tort against pediatric gender clinics and other entities pushing gender-transition procedures that cause bodily injury to children or harm the mental health of children; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Judiciary

 

S.460 – A bill to amend the Indian Health Care Improvement Act to establish an urban Indian organization confer policy for the Department of Health and Human Services; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Indian Affairs

 

S.462 – A bill to amend the Public Health Service Act to modify the loan repayment program for the substance use disorder treatment workforce to relieve workforce shortages; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.464 – A bill to amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for tobacco products and electronic nicotine delivery systems; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Finance

 

S.466 – A bill to provide for the National Academies of Sciences, Engineering, and Medicine to study and report on a Federal research agenda to advance the understanding of perfluoroalkyl and polyfluoroalkyl substances, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Commerce, Science, and Transportation

 

S.468 – A bill to amend the Public Health Service Act to enhance compliance with hospital price transparency requirements, and for other purposes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.470 – A bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

 

S.471 – A bill to amend title XIX of the Social Security Act to allow for greater State flexibility with respect to excluding providers who are involved in abortions; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

 

S.476 – A bill to amend title XI of the Social Security Act to protect access to genetically targeted technologies; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.492 – A bill to prohibit the imposition of certain substantial burdens, relating to COVID-19 vaccine mandates, on religious exercise, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Judiciary

 

S.526 – A bill to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

President Joe Biden delivered his State of the Union (SOTU) address on Tuesday; the speech highlighted his administration’s accomplishments on infrastructure, the climate, and consumer protections over the past two years. The President promised to not allow the nation to default on its debt, calling on Congress to pass a clean increase of the debt-ceiling and criticizing Republicans seeking to use debt-ceiling negotiations to force spending cuts. Biden’s speech also commended the work done by his administration to reach a point in which “COVID no longer controls our lives,” while acknowledging the need for Congress to fund ongoing efforts to support the development of new vaccines and treatments in response to emerging COVID-19 variants. Other health care priorities covered in the President’s address include:

Drug pricing: The President touted provisions contained in last year’s Inflation Reduction Act to cap out-of-pocket (OOP) drug costs for Medicare beneficiaries at $2,000 per year, allow drug price negotiations for the first time under the Medicare program, and to cap the OOP cost of insulin at $35 per month for Medicare beneficiaries. He also called for a universal $35 insulin price cap for all Americans.
Medicaid expansion: Biden called on the 11 states that have yet to expand their Medicaid programs to fill the coverage gap for the two million uninsured individuals who earn too much to qualify for Medicaid but too little to receive subsidies through their health insurance exchange.
Abortion: The President called on Congress to codify Roe v. Wade and stated that he would veto any national abortion ban passed by Congress.
Cancer Moonshot: Biden recommitted his support for the Cancer Moonshot initiative and called on Congress to do the same. The initiative aims to reduce the nation’s cancer death rate by 50% over the next 25 years.
Medicare: The President stated his plans to extend the Medicare Trust Fund by at least two decades and pledged to veto any attempts to cut the Medicare program.
The President’s full remarks, as prepared for delivery, can be found here. The Republican responses to the SOTU were delivered by Governor Sarah Huckabee Sanders (Ark.) and newly- elected Rep. Juan Ciscomani (Ariz.-06).

 

 

Senate Judiciary Advances Five Bipartisan Drug Pricing Bills

The Senate Judiciary Committee advanced five bipartisan bills aimed at reforming the drug patent system and increasing competition in the pharmaceutical marketplace. Each of the bills were reported favorably by voice vote. The following legislation was considered:

• S. 79, Interagency Patent Coordination and Improvement Act of 2023, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents.
• S. 113, Prescription Pricing for the People Act of 2023, to require the Federal Trade Commission (FTC) to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations.
• S. 142, Preserve Access to Affordable Generics and Biosimilars Act, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
• S. 148, Stop STALLING Act, to enable the FTC to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns.
• S. 150, Affordable Prescriptions for Patients Act of 2023, to amend the Federal Trade Commission Act to prohibit product hopping. During consideration of this bill, Sen. Mazie Hirono (D-Hawaii) expressed concerns about potential unintended consequences, such as companies avoiding follow-on research out of fear of litigation. Sen. Mike Lee (R-Utah) also argued that the FTC already has the authority necessary to address such anticompetitive behavior.

 
While lawmakers appeared optimistic about the bills’ chances of passing the Senate, it remains unclear whether they would be taken up by the Republican-controlled House of Representatives.
 

Finance, HELP Leadership Consider Common Ground for 118th Congress

With congressional committees convening for their first organizational meetings of the 118th Congress in recent weeks, panel leadership have begun to shed light on their agendas for the next two years. In the Senate Finance Committee, Ranking Member Mike Crapo (R-Idaho) outlined health care priorities that largely align with those of Chair Ron Wyden (D-Ore.). While Crapo has highlighted the need for oversight of the Biden administration’s implementation of the Inflation Reduction Act’s drug pricing provisions, both leaders are aiming to target rising health care costs, health care workforce shortages, and access to telehealth during the 118th Congress. Sen. Ben Cardin (D-Md.) will serve as the new chair of the Senate Finance Health Care Subcommittee, replacing Sen. Debbie Stabenow (D-Mich.) who will remain a member of the subcommittee. Sen. Steve Daines (R-Mont.) will continue to serve as the subcommittee’s ranking member. Cardin has said that he will focus on behavioral health and care for those with substance use disorders, expanding Medicaid and Medicare coverage for dental health, and maintaining telehealth access as subcommittee chair. Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) also previewed their common ground priorities during the panel’s first meeting of the 118th Congress last week. These focus areas include the opioid crisis, oral health care, mental health care, and prescription drug costs, with Ranking Member Cassidy specifically acknowledging the need to balance concerns around affordability and medical innovation in drug pricing.

 

HHS Prepares States, Stakeholders For End of PHE

U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra set a letter to governors last week discussing his decision to renew the COVID-19 public health emergency (PHE) for the final time, effective February 11, and to terminate the PHE on May 11. HHS also released a fact sheet providing a transition roadmap describing the impact of the PHE expiration. Those PHE-linked flexibilities and policies that will be affected by the end of the emergency declaration include:

Medicare beneficiaries who are enrolled in Part B will continue to have coverage without cost sharing for laboratory- conducted COVID-19 tests when ordered by a provider, but their current access to free over the counter (OTC) COVID-19 tests will end.
The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end.
State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until the last day of the first calendar quarter that begins one year after the last day of the COVID-19 PHE. That means that mandatory coverage will end on September 30, 2024.
Reporting of COVID-19 laboratory results and immunization data to CDC will change. HHS will no longer have the express authority to require lab test reporting for COVID-19. Hospital data reporting will continue as required by the Centers for Medicare and Medicaid Services conditions of participation through April 30, 2024, but reporting may be reduced from the current daily reporting to a lesser frequency.
Certain Food and Drug Administration COVID-19-related guidance documents for industry that affect clinical practice and supply chains will end or be temporarily extended. FDA is in the process of addressing which policies are no longer needed and which should be continued, and the agency will announce plans for each guidance prior to the end of the PHE.
During the PHE, manufacturers of certain devices related to the diagnosis and treatment of COVID-19 have been required to notify the FDA “of a permanent discontinuance in the manufacture of the device” or “an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States.” This requirement will end when the PHE ends.
Public Readiness and Emergency Preparedness (PREP) Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for the area where countermeasures are administered.
The ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities.
The Department will host a briefing on Monday, February 13 at 3:00 p.m. ET to discuss the end of the PHE. Registration information is available here.

 

BCBSA Proposes Policies to Reduce Health Care Costs

The Blue Cross Blue Shield Association (BCBSA) released a proposed plan last week to lower health care costs which it estimates would reduce federal deficits by $337 billion over the next decade and reduce overall national health expenditures by $767 billion. Their proposal focuses on lowering the prices paid for health care in Medicare and the commercial insurance market through six policies: adopting site-neutral payment policies in Medicare, expanding antitrust funding and enforcement, prohibiting anti-competitive provisions in provider contracts, facilitating generic drug and biosimilar entry, limiting the exclusivity period for biologicals, and repealing the tax deduction for drug advertising. BCBSA also proposes two additional policies which it argues will protect against increases in health care costs: preserving the ability of health insurers to use step therapy and pharmacy networks and to continue allowing health insurers to utilize prior authorization.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Oversight and Investigations and Subcommittee on Health field hearing “President Biden’s Border Crisis is a Public Health Crisis;” 6:00 p.m.; February 15

Senate Health, Education, Labor, and Pensions Committee hearing “Examining Health Care Workforce Shortages: Where Do We Go From Here?” 10:00 a.m.; February 16

Senate Committee on Commerce, Science, and Transportation hearing to examine bringing transparency and accountability to pharmacy benefit managers; 10:00 a.m.; February 16

 

POLICY BRIEFINGS

Recently Introduced Health Legislation

H.R.830 – To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.831 – To amend title XVIII of the Social Security Act to provide for coverage under part B of the Medicare program for medically necessary dental procedures; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.833 – To amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs, and for other purposes; Sponsor: Graves, Sam [Rep.-R-MO-6]; Committees: House – Energy and Commerce; Ways and Means; Budget

 

H.R.834 – To amend title XVIII of the Social Security Act to support rural residency training funding that is equitable for all States, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.849 – To require the Department of Defense to share best practices with, and offers training to, State and local first responders regarding how to most effectively aid victims who experience trauma-related injuries; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Armed Services

 

H.R.853 – To amend titles II and XVIII of the Social Security Act to establish a Social Security Surplus Protection Account in the Federal Old-Age and Survivors Insurance Trust Fund to hold the Social Security surplus and a Medicare Surplus Protection Account in the Federal Hospital Insurance Trust Fund to hold the Medicare surplus, to provide for suspension of investment of amounts held in such Accounts until enactment of legislation providing for investment of the Trust Funds in investment vehicles other than obligations of the United States, and to establish a Social Security and Medicare Part A Investment Commission to make recommendations for alternative forms of investment of the Social Security and Medicare surpluses; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Ways and Means

 

S.J.Res.10 – A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Tuberville, Tommy [Sen.-R-AL]; Committees: Senate – Veterans’ Affairs

 

S.280 – A bill to ensure that only licensed health care professionals furnish disability examinations under a certain Department of Veterans Affairs pilot program for use of contract physicians for disability examinations, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs

 

S.288 – A bill to prevent, treat, and cure tuberculosis globally; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Foreign Relations

 

S.289 – A bill to improve national security at the National Institutes of Health, to address national security issues in the licensure of biological products, to address national security considerations in research at the Department of Health and Human Services, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.302 – A bill to amend title 10, United States Code, to direct the Secretary of Defense to provide colorectal cancer screening for members of the uniformed services who served in locations associated with toxic exposure, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Armed Services

 

H.Res.99 – Supporting the goals and ideals of “National Black HIV/AIDS Awareness Day”; Sponsor: Lee, Barbara [Rep.- D-CA-12]; Committees: House – Energy and Commerce H.J.Res.31 – Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Cloud, Michael [Rep.-R- TX-27]; Committees: House – Veterans’ Affairs

 

H.R.875 – To authorize the Secretary of the Treasury to issue obligations to make Medicare and Social Security payments, despite the debt limit being reached; Sponsor: James, John [Rep.-R-MI-10]; Committees: House – Ways and Means

 

H.R.880 – To establish a program to provide for women’s heart health continuing medical education, and for other purposes; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Energy and Commerce

 

S.312 – A bill to amend title XVIII of the Social Security Act to modernize payments for ambulatory surgical centers under the Medicare program, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

S.315 – A bill to direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.323 – A bill to ensure the privacy of pregnancy termination or loss information under the HIPAA privacy regulations and the HITECH Act; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.324 – A bill to authorize the Secretary of Health and Human Services to carry out activities relating to neglected diseases of poverty; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.326 – A bill to direct the Secretary of Veterans Affairs to carry out a study and clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

H.Res.118 – Maintaining Medicare; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.885 – To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce; Armed Services; Veterans’ Affairs; Judiciary; Ways and Means; Science, Space, and Technology

 

H.R.894 – To amend title 38, United States Code, to provide for limitations on copayments for contraception furnished by the Department of Veterans Affairs, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.896 – To ensure that patients receive accurate health care information by prohibiting misleading and deceptive advertising or representation in the provision of health care services, to require the identification of the license of health care professionals, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.901 – To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Energy and Commerce

 

H.R.902 – To provide for further comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.949 – To amend title XI of the Social Security Act to eliminate the general Medicaid funding limitations for territories of the United States, and for other purposes; Sponsor: Sablan, Gregorio Kilili Camacho [Del.-D-MP-At Large]; Committees: House – Energy and Commerce

 

H.R.952 – To amend title XIX of the Social Security Act to renew the application of the Medicare payment rate floor to primary care services furnished under the Medicaid program, and for other purposes; Sponsor: Schrier, Kim [Rep.-D- WA-8]; Committees: House – Energy and Commerce

 

H.R.955 – To amend title XVIII of the Social Security Act to allow payments under the Medicare program for certain items and services furnished by off-campus outpatient departments of a provider to be determined under the prospective payment system for hospital outpatient department services, and for other purposes; Sponsor: Smith, Adrian [Rep.-R- NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.960 – To amend title XVIII of the Social Security Act to prohibit the use of an inpatient-only list in designating hospital outpatient services under the Medicare program; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.972 – To amend title XVIII of the Social Security Act to modernize payments for ambulatory surgical centers under the Medicare program, and for other purposes; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

The Biden administration announced plans last week to end the COVID-19 emergency declarations on May 11. The decision applies to both the national emergency and public health emergency (PHE) in response to COVID-19 that have remained in place for over three years since they were first declared. The end of the emergency declarations will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will be responsible for paying for vaccines, tests, and treatments out-of-pocket, while insured individuals may see the cost of such products increase. Vaccines will remain free for Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. Other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE would also end, though some measures have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extends certain telehealth policies through 2024 and permits states to resume Medicaid redeterminations in April. Other provisions, such as the Medicare coverage requirement waivers (like the three-day hospital stay requirement prior to a skilled nursing facility admission) and permission for patients to get extended supplies of many drugs under the Medicare prescription drug benefit, were not extended in the year-end funding bill. Hospitals will also no longer receive the 20% increased Medicare payment for the treatment of COVID-19 patients. According to a senior administration official, the transition period over the next three months will allow the White House to “begin the process of a smooth operational wind-down of the flexibilities enabled by the COVID-19 emergency declarations.” The announcement was made within a series of White House statements in opposition to several bills passed by the House of Representatives warning that ending the PHE too soon would have “highly significant impacts on our nation’s health system and government operations.” The bills passed the House include:
H.R. 497 – Freedom for Health Care Workers Act, to block the federal COVID-19 vaccine mandate for health care workers under the Medicare and Medicaid programs;
H.R. 382 – Pandemic is Over Act, to end the COVID-19 PHE;
H.R. 139 – SHOW UP Act of 2023, to end COVID-era telework policies for federal workers; and
H.J. Res. 7, to terminate the national emergency declared on March 13, 2020.
This week, the House plans to vote on legislation (H.R. 185) that would end the COVID-19 vaccine mandate for international travelers entering the U.S. Proponents of the bill argue that the requirement should be dropped given the ending of the COVID-19 emergency declarations on May 11.

 

President’s FY24 Budget to Be Released March 9

The White House plans to release President Joe Biden’s fiscal year (FY) 2024 budget on Thursday, March 9. According to Brian Deese, National Economic Council Director, and Shalanda Young, Office of Management and Budget Director, the budget will “show how the President plans to invest in America, continue to lower costs for families, protect and strengthen Social Security and Medicare, and reduce the deficit.” They called on Republicans to release their own budget containing proposals for reducing the deficit. Majority Leader Steve Scalise (R-La.) confirmed the House GOP’s plan to release their proposed budget by April. Republicans have stated their intent to balance the federal budget within the next decade.

 

Wyden Requests Details on IRA’s Drug Rebate Provisions

Senate Finance Committee Chair Ron Wyden (D-Ore.) has sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting information on how the agency plans to collect the Medicare Part B and Part D inflation rebates created as a part of the drug pricing provisions in last year’s Inflation Reduction Act. The law requires manufacturers to pay a rebate to Medicare when they increase their drug prices faster than the rate of inflation, with Medicare penalizing manufacturers for price increases that outpace inflation starting in October 2022 for Part D drugs and in January 2023 for Part B drugs. Wyden asks for an explanation of how rebates will be calculated and a timeline for their implementation.

 

Senators Criticize Lack of FDA Vaping Regulation Enforcement

Abipartisan group of 13 senators has sent a letter to the U.S. Department of Health and Human Services criticizing the “repeated failures” of the Food and Drug Administration (FDA) to regulate the tobacco and e-cigarette market and to take action against companies marketing illegal vaping products. The agency recently estimated that it will not finish reviewing marketing applications from e-cigarette manufacturers until the end of December, six months later than previously projected. The FDA already stands 16 months past a court-ordered deadline to complete review of e-cigarette marketing applications. The lawmakers argue that as many as one million children will be at risk of starting e-cigarette use because of this delay. Their letter follows a report from the Reagan-Udall Foundation which found that the absence of “timely enforcement action jeopardizes public health and undermines creditability and effectiveness in tobacco product regulation.”

 

Legislators Urge Elevation of ONDCP

Abipartisan, bicameral group of 55 legislators is urging President Joe Biden to reinstate the Director of the Office of National Drug Control Policy (ONDCP) to a cabinet-level position amid rising rates of drug overdoses across the United States. They request that the President announce the change during this week’s State of the Union address, arguing that re-elevating “ONDCP to the Cabinet will allow it to marshal the full resources of the federal government against this scourge of overdoses and demonstrate to the Congress and the American people [his] commitment to ending it.” Overdoses currently represent the leading cause of death for Americans aged 18 to 45.

 

Lawmakers Request More Funding for KidneyX

Abipartisan, bicameral group of lawmakers is asking the Biden administration to increase funding for kidney care in the President’s fiscal year 2024 budget. The lawmakers request a $25 million investment in KidneyX – a partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology that aims to encourage innovation in the prevention, diagnosis, and treatment of kidney diseases. “With more funding, KidneyX could expand the number of innovators it supports and accelerate the development of transformative technologies, particularly the artificial kidney,” the letter states. The lawmakers argue this investment could ultimately reduce the amount of money the nation spends on kidney care and the treatment of kidney failure. The letter was signed by Sens. Ben Cardin (D-Md.) and Todd Young (R-Ind.), and Reps. Suzan DelBene (D-Wash.) and Larry Bucshon (R-Ind.).

 

Democrats Ask Manufacturer to Revise Mifepristone Label

Agroup of Senate Democrats led by Sens. Mazie K. Hirono (D-Hawaii), Maggie Hassan (D-N.H.), and Elizabeth Warren (D-Mass.) is urging Danco Laboratories to add a miscarriage management indication to the drug label for Mifeprex (mifepristone). The lawmakers argue that because miscarriage is not currently included on the approved label, health care providers lack clear legal guidance on the product’s use and “patients experiencing early pregnancy loss who need mifepristone cannot easily access this critical treatment, placing them at risk of serious injury and death.” The Food and Drug Administration recently rejected a citizen petition filed by the American College of Obstetricians and Gynecologists, along with 48 other organizations, for such a label change on the grounds that only the manufacturer of the drug has the authority to request this type of change.

 

GAO Releases Report on Nation’s Ability to Investigate Pandemic Origins

The Government Accountability Office (GAO) released a new report last week examining the United States’ lack of a national strategy for investigating the origins of disease outbreaks and pandemics. The report details the technologies available for researchers to investigate a pandemic’s origin – such as genomic sequencing, bioinformatics analysis, genetic databases, serology, and epidemiological surveillance – and their limitations. Experts told the GAO, however, that such technologies are not the limiting factor for determining the likely origin of a pandemic. The agency identified three cross- cutting challenges facing disease origin investigations: a lack of sufficient access to samples and genetic sequence data; a lack of standardized processes for submitting, accessing, and using genetic sequence data; and a lack of a sufficient and skilled interdisciplinary workforce. The report also outlines five policy options to address these challenges:
Establish multilateral agreements for accessing and sharing samples and genetic sequence data;
Develop standardized processes for genetic sequence database use;
Improve current, or develop new, genetic sequence database tools;
Encourage the development, retention, and growth of a workforce with the critical skills needed for pandemic origin investigations; and
Augment or develop a national strategy to better coordinate and collaborate domestically and internationally on pandemic origin investigations.
A GAO representative testified before the House Energy and Commerce Oversight and Investigations Subcommittee during the panel’s first hearing of the 118th Congress, titled “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events” last week. Republican leadership of the full committee have also revived their investigative work into the origins of COVID-19, sending letters to the National Institutes of Health and EcoHealth Alliance requesting documents related to research done at the Wuhan Institute of Virology.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Joint Subcommittee on Oversight and Investigations and Subcommittee on Health hearing “The Federal Response to COVID-19;” 10:00 a.m.; February 8
Senate Judiciary Committee Executive Business Meeting to consider nominations and markup the following bills: S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; S. 148, Stop STALLING Act; and S. 150, Affordable Prescriptions for Patients Act; 9:00 a.m.; February 9
 

Recently Introduced Health Legislation

S.131 – A bill to amend chapter 81 of title 5, United States Code, to cover, for purposes of workers” compensation under such chapter, services by physician assistants and nurse practitioners provided to injured Federal workers, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Homeland Security and Governmental Affairs
 
S.132 – A bill to require a pilot program on activities under the pre-separation transition process of members of the Armed Forces for a reduction in suicide among veterans, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Veterans” Affairs
 
S.133 – A bill to extend the National Alzheimer”s Project; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.134 – A bill to require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer”s Project Act; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.141 – A bill to amend title 38, United States Code, to improve certain programs of the Department of Veterans Affairs for home and community based services for veterans, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans” Affairs
 
S.142 – A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary
 
S.146 – A bill to reduce the price of insulin for patients; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.148 – A bill to enable to Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary
 
S.150 – A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary
 
H.Res.73 – Expressing the sense of the House of Representatives that Medicare and Social Security provide an essential benefit for current enrollees and should be strengthened for future generations; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Ways and Means; Energy and Commerce
 
H.R.618 – To amend chapter 81 of title 5, United States Code, to cover, for purposes of workers” compensation under such chapter, services by physician assistants and nurse practitioners provided to injured Federal workers, and for other purposes; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Education and the Workforce
 
H.R.619 – To extend the National Alzheimer”s Project; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce
 
H.R.620 – To require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer”s Project Act; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce
 
H.R.629 – To amend title XI of the Social Security Act to provide for State approval and implementation of specified waivers under the Medicaid program; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce
 
H.R.630 – To amend the Indian Health Care Improvement Act to establish an urban Indian organization confer policy for the Department of Health and Human Services; Sponsor: Grijalva, Raúl M. [Rep.-D-AZ-7]; Committees: House – Natural Resources; Energy and Commerce
 
H.R.632 – To amend title XIX of the Social Security Act and Public Health Service Act to improve the reporting of abortion data to the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Norman, Ralph [Rep.- R-SC-5]; Committees: House – Energy and Commerce
 
H.R.633 – To amend title XXVII of the Public Health Service Act to exempt certain direct primary care arrangements from regulation as health insurance coverage; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce
 
H.R.635 – To amend title XVIII of the Social Security Act to permanently include certain HCPCS codes as telehealth services under such title, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce; Ways and Means
 
S.164 – A bill to prohibit the consideration of COVID-19 vaccination status in determining eligibility for organ donation or transplantation, and in providing services to Medicare or Medicaid beneficiaries; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.166 – A bill to amend the Family and Medical Leave Act of 1993 to provide leave for the spontaneous loss of an unborn child, and for other purposes; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Finance
 
S.167 – A bill to prohibit vaccination mandates for COVID-19; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Judiciary
 
S.169 – A bill to prohibit certain COVID-19 vaccination mandates for minors, and to require parental consent for COVID-19 vaccination of minors; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.171 – A bill to prohibit the consideration of patients” race, color, religion, sex, national origin, age, disability, vaccination status, veteran status, or political ideology or speech in determining eligibility for COVID-19 treatments and vaccines distributed by the Federal Government; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.172 – A bill to terminate any existing mask mandates imposed by the Federal Government, to prevent the implementation of new mask mandates, to preserve individual liberty, and for other purposes; Sponsor: Cruz, Ted [Sen.-R- TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.181 – A bill to protect individual liberty, ensure privacy, and prohibit discrimination with respect to the vaccination status of individuals, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
H.R.670 – To amend title IV of the Public Health Service Act to direct the Secretary of Health and Human Services to establish a clearinghouse on intellectual disabilities, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce
 
H.R.677 – To amend the Internal Revenue Code of 1986 to make improvements to Health Savings Accounts; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Ways and Means
 
S.198 – A bill to amend title XVIII of the Social Security Act to modernize provisions relating to rural health clinics under Medicare; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance
 
S.204 – A bill to amend title 18, United States Code, to prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion; Sponsor: Thune, John [Sen.-R- SD]; Committees: Senate – Judiciary
 
S.205 – A bill to promote minimum State requirements for the prevention and treatment of concussions caused by participation in school sports, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.208 – A bill to establish a procedure for terminating a determination by Surgeon General to suspend certain entries and imports from designated places; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.213 – A bill to authorize the Secretary of the Treasury to issue obligations to make Medicare and Social Security payments, despite the debt limit being reached; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Finance
 
S.216 – A bill to amend title 38, United States Code, to modify the family caregiver program of the Department of Veterans Affairs to include services related to mental health and neurological disorders, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans” Affairs
 
H.R.704 – To amend title XVIII of the Social Security Act to permit nurse practitioners and physician assistants to satisfy the documentation requirement under the Medicare program for coverage of certain shoes for individuals with diabetes; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Energy and Commerce; Ways and Means
 
H.R.706 – To amend the Food and Nutrition Act of 2008 to allow households with children with chronic medical conditions to deduct allowable medical expenses incurred by such household member that exceeds $35 per month; Sponsor: Brown, Shontel M. [Rep.-D-OH-11]; Committees: House – Agriculture
 
H.R.711 – To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce
 
H.R.732 – To rename the program under part C of title XVIII of the Social Security Act, and for other purposes; Sponsor: Pocan, Mark [Rep.-D-WI-2]; Committees: House – Ways and Means; Energy and Commerce
 
Recently Introduced Health Legislation Contd.
 
H.R.733 – To direct the Secretary of Veterans Affairs to improve mental health care for veterans through the establishment of a minimum requirement for the number of Vet Centers per State; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Veterans’ Affairs
 
S.230 – A bill to amend title XVIII of the Social Security Act to support rural residency training funding that is equitable for all States, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate ” Finance
 
S.237 – A bill to preserve access to abortion medications; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.242 – A bill to amend the Family and Medical Leave Act of 1993 and title 5, United States Code, to permit leave to care for a domestic partner, parent-in-law, or adult child, or another related individual, who has a serious health condition, and to allow employees to take, as additional leave, parental involvement and family wellness leave to participate in or attend their children’s and grandchildren’s educational and extracurricular activities or meet family care needs; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.260 – A bill to amend title XVIII of the Social Security Act to permit nurse practitioners and physician assistants to satisfy the documentation requirement under the Medicare program for coverage of certain shoes for individuals with diabetes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance
 
S.265 – A bill to reauthorize the rural emergency medical service training and equipment assistance program, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
H.Res.93 – Expressing support for the designation of February 4, 2023, as “National Cancer Prevention Day”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce
 
H.R.746 – To amend title 38, United States Code, to expand certain rehabilitation programs for certain veterans with service-connected disabilities; Sponsor: Obernolte, Jay [Rep.-R-CA-23]; Committees: House – Veterans’ Affairs
 
H.R.751 – To amend title XVIII of the Social Security Act to require as a condition of satisfying the definition of an approved medical residency training program for purposes of payments under Medicare for costs related to graduate medical education for hospitals operating such a program to submit information to encourage more equitable treatment of osteopathic and allopathic candidates in the residency application and review process, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce
 
H.R.753 – To direct the Secretary of Veterans Affairs to use on-site regulated medical waste treatment systems at certain Department of Veterans Affairs facilities, and for other purposes; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs
 
H.R.754 – To establish an advisory commission regarding eligibility for health care furnished by the Secretary of Veterans Affairs; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs
 
H.R.757 – To amend the Controlled Substances Act to prohibit manufacturing or distributing candy-flavored controlled substances for minors, and for other purposes; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Judiciary; Energy and Commerce
 
H.R.762 – To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce
 
H.R.763 – To establish an Office of Manufacturing Security and Resilience in the Department of Commerce, to provide for a Department of Commerce assessment and strategy to counter threats to critical supply chains, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce
 
H.R.766 – To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Budget
 
H.R.767 – To preserve access to abortion medications; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce
 
H.R.772 – To prohibit the Federal Government from issuing vaccine passports, to prohibit businesses from discriminating against patrons and customers by requiring documentation certifying COVID-19 vaccination, or post-transmission recovery, as a condition on the provision of products or services, and for other purposes; Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House – Oversight and Accountability; Energy and Commerce; Education and the Workforce
 
H.R.773 – To help persons in the United States experiencing homelessness and significant behavioral health issues, including substance use disorders, by authorizing a grant program within the Department of Housing and Urban Development to assist State and local governments, Continuums of Care, community-based organizations that administer both health and homelessness services, and providers of services to people experiencing homelessness, better coordinate health care and homelessness services, and for other purposes; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Financial Services
 
H.R.774 – To establish an Office of Manufacturing Security and Resilience in the Department of Commerce, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce
 
H.R.789 – To amend the Family and Medical Leave Act of 1993 and title 5, United States Code, to permit leave to care for a domestic partner, parent-in-law, or adult child, or another related individual, who has a serious health condition, and to allow employees to take, as additional leave, parental involvement and family wellness leave to participate in or attend their children’s and grandchildren’s educational and extracurricular activities or meet family care needs; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration
 
H.R.796 – To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce
 
H.R.801 – To amend title III of the Public Health Service Act to provide for suspension of entries and imports from designated countries to prevent the spread of communicable diseases and import into the United States of certain controlled substances; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Energy and Commerce
 
H.R.808 – To amend title 38, United States Code, to improve the assignment of patient advocates at medical facilities of the Department of Veterans Affairs; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Veterans’ Affairs
 
H.R.812 – To repeal the Inflation Reduction Act of 2022; Sponsor: Ogles, Andrew [Rep.-R-TN-5]; Committees: House – Ways and Means; Energy and Commerce; Agriculture; Natural Resources; Financial Services; Science, Space, and Technology; Transportation and Infrastructure; Oversight and Accountability
 
H.R.814 – To protect benefits provided under Social Security, Medicare, and any other program of benefits administered by the Social Security Administration or the Centers for Medicare and Medicaid Services; Sponsor: Pocan, Mark [Rep.-D- WI-2]; Committees: House – Rules
 
H.R.815 – To amend title 38, United States Code, to make certain improvements relating to the eligibility of veterans to receive reimbursement for emergency treatment furnished through the Veterans Community Care program, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Veterans’ Affairs
 
H.R.822 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to eligible entities to establish or maintain a student mental health and safety helpline, and for other purposes; Sponsor: Stewart, Chris [Rep.-R-UT-2]; Committees: House – Energy and Commerce
 
H.R.824 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income and Security Act of 1974, and the Internal Revenue Code of 1986 to treat benefits for telehealth services offered under a group health plan or group health insurance coverage as excepted benefits; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means
 
H.R.826 – To establish a National Resilience Center of Excellence in the Department of Commerce, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce