Congress Departs for August Recess

Lawmakers completed their final workdays before the congressional August recess last week. While the Senate passed its $886 billion annual defense policy bill with overwhelming bipartisan support, Foreign Relations Chair Bob Menendez (D-N.J.) was unsuccessful in his attempt to attach a five-year reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) to the National Defense Authorization Act. Republicans are pushing to restore a Trump-era abortion restriction blocking funding for any groups that provide or promote abortion as a part of PEPFAR reauthorization.

For the first time since 2018, the Senate Appropriations Committee has completed work on all 12 annual spending bills, advancing the Labor-Health and Human Services-Education package out of committee on Thursday. All 12 of the Senate appropriations measures received bipartisan support. The Labor-HHS bill includes $224.4 billion in funding, a roughly $14.5 billion increase. The U.S. Department of Health and Human Services Department (HHS) would receive $117 billion. A full summary of the bill is available here. Bill text, as amended, is available here. The bill report, as amended, is available here. Adopted amendments are available here. Congressionally Directed Spending projects included in the bill are available here.

On the House side, Republicans pivoted away from plans to vote on the chamber’s fiscal year (FY) 2024 Agriculture-Rural Development-Food and Drug Administration appropriations bill on the floor last week. The bill faced pushback from conservatives demanding further spending cuts. Several moderate members also expressed reservations about a policy contained in the bill to restrict access to the abortion medication mifepristone.

The Senate is scheduled to reconvene on September 5, and the House is scheduled to return on September 12. Lawmakers will have a lengthy list of expiring programs and must-pass legislation to complete before September 30, including FY 2024 government funding, the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, animal drug user fee reauthorization, PEPFAR reauthorization, and funding for public health programs (community health centers, National Health Service Corps, Children’s Hospitals GME, etc.).

 

Congress Passes Bill to Overhaul Nation’s Organ Transplant System

Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) to increase competition in the nation’s organ transplant network last week. The bill would allow the Health Resources and Services Administration to open competitive bidding on multiple contracts for public and private entities to manage the Organ Procurement and Transplantation Network (OPTN). The legislation would also require a Government Accountability Office report on the financing of OPTN. The United Network for Organ Sharing (UNOS) has managed the OPTN contract since 1986. The current OPTN contract with UNOS is set to expire and be up for renewal on September 30. The legislation passed the House of Representatives by voice vote and was adopted by the Senate through unanimous consent. The bill will now be sent to President Joe Biden to be signed into law.

 

Senate Finance Advances PBM Package

The Senate Finance Committee voted 26-1 to advance a series of proposals to reform the pharmacy benefit manager (PBM) industry last week. Sen. Ron Johnson (R-Wis.) was the only member to vote against the bill. The Modernizing and Ensuring PBM Accountability (MEPA) Act would delink PBMs’ compensation from manufacturer list prices, requiring that payments to PBMs be based on a bona fide service fee that is not tied to the list price of a drug. It would ban the practice of spread pricing in state Medicaid programs, and require Medicare Advantage and Part D plans to use standardized pharmacy performance measures for the purposes of incentive payments, price concessions, or fees charged to a pharmacy. The bill also directs the U.S. Department of Health and Human Services Office of the Inspector General to review the state of PBM compensation and to study Part D drug mark-ups. The Congressional Budget Office (CBO) estimates that the measure would produce approximately $666 million in savings through 2028. The measures will likely be made a part of a larger package of drug pricing reforms expected to be considered by the Senate before the end of the year. In a statement released following Wednesday’s markup, Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) committed “to continue working on additional proposals that will constitute a more comprehensive suite of reforms, and requested feedback from the CBO on proposals that would help to cut out-of-pocket costs, increase pharmacy access and (ensure) that seniors benefit from lower-cost biosimilars.”

 

House Ways and Means Approves Health Care Transparency Bills Along Party Lines

The House Ways and Means Committee advanced legislation to increase transparency in the nation’s health care system last week. The Health Care Price Transparency Act (H.R. 4822) would require pharmacy benefit managers and group health plans to submit an annual report to Part D plan sponsors containing a series of information on prescription drug pricing and spending effective three years after enactment of the legislation. It would also limit beneficiary cost sharing in Part D to no more than the average net price of a drug staring in 2027. The bill also included provisions to address prior authorization policies in Medicare Advantage based on the bipartisan Improving Seniors’ Timely Access to Care Act which passed the House in the 117th Congress. The Providers and Payers COMPETE Act (H.R. 3284) would require an annual report from the U.S. Department of Health and Human Services on the effect of Medicare regulations on provider and payer consolidation, and the impact of such consolidation on the health care delivery system. The bills were approved by party line votes. Democrats argued that the bills will not meaningfully lower prescription drug costs, and expressed opposition to the exemption of Medicare Advantage plans from increased transparency requirements and the absence of reporting requirements to shed light on private equity involvement in the health care system. The two bills are expected to be incorporated into a larger health care package that includes other price transparency legislation advanced by the Education and the Workforce and Energy and Commerce committees earlier this year.

 

Sanders Postpones Primary Care, Workforce Markup

Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) postponed consideration of his primary care and health workforce package originally scheduled for markup last Thursday. In Sanders’ statement announcing the change of plans, the Chairman indicated that he is working with Sen. Roger Marshall, MD (R-Kan.) to prepare a “major piece of bipartisan primary care legislation” for consideration by the first week of September. The original package proposed by Sanders faced opposition from Republican members of the committee, who argued that the funding authorized by the measure – totaling $100 billion – was too high. The bill included between $10.2 billion and $13.42 billion per year for community health centers. It would have also prohibited hospitals from charging facility fees for services provided by off-site physicians. The reauthorization package advanced out of the House Energy and Commerce Committee provides only a slight increase for community health centers – from $4 billion to $4.2 billion annually for the next two years.

 

Lawmakers Urge Medicare Physician Payment Reform

Agroup of 101 lawmakers led by Reps. Larry Bucshon (R-Ind.) and Ami Bera (D-Calif.) have sent a letter to House of Representatives leadership on the need to prioritize Medicare physician payment reform. The lawmakers argue that the Medicare physician payment system’s failure to maintain levels of reimbursement and to adequately incentivize high- quality care has led to poorer health outcomes and shortages of health care providers. The lawmakers urge Congress to enact reforms to the Medicare Access and CHIP Reauthorization Act and to establish a stable payment mechanism that appropriately pays for health outcomes in order to “keep our patients safe, access to care available, and the health care workforce strong.”

 

E&C Republicans Release Drug Shortages Discussion Draft

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) released a discussion draft last week containing proposals to address the nation’s ongoing drug shortages. The bill would provide manufacturers of generic, sterile injectable drugs for serious diseases more market flexibility to invest in manufacturing and speed production when potential shortages arise. The draft would increase group purchasing organization disclosure requirements, require the Food and Drug Administration to exercise its existing reporting requirement authorities, and establish a pilot program to conduct preapproval inspections of new domestic sterile manufacturing facilities. It would also require analysis of the impact of federal policies like the 340B drug pricing program, the Medicaid generic drug inflationary rebate, and Medicare reimbursement policy on drug shortages. Feedback on the discussion draft should be submitted to [email protected] by August 25, 2023. Ranking Member Frank Pallone, Jr. (D-N.J.) criticized the bill, expressing concerns that its proposals are “handouts to pharmaceutical corporations that would increase costs for patients and potentially lead to more shortages.”

 

Bipartisan, Bicameral RFI on CBD Regulation

Bipartisan leadership of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee are requesting information from stakeholders about the Food and Drug Administration’s (FDA) regulation of cannabidiol (CBD). The effort seeks to address questions about the best way to provide a legal pathway to market for CBD products, and follows an announcement by the FDA earlier this year on the need for legislation to inform CBD product regulation. The information gathered will support the lawmakers’ assessment of the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market. Comments in response to the request for information (RFI) are due to the committees ([email protected] and [email protected]) by August 18.

 

POLICY BRIEFINGS

 

Lawmakers Reintroduce Value in Health Care Act

Reps. Darin LaHood (R-Ill.), Suzan DelBene (D-Wash.), Kim Schrier, MD (D-Wash.), Brad Wenstrup (R-Ohio), Earl Blumenauer (D-Ore.), and Larry Bucshon, MD (R-Ind.) have reintroduced a bipartisan bill (H.R. 5013) that aims to increase participation in Accountable Care Organizations (ACOs). The Value in Health Care Act would revise Medicare’s Alternative Payment Models program to incentivize greater participation in value-based health care. The legislation would increase the percentage of shared savings beginning participants receive, modify program risk adjustment and performance metrics, strengthen technical support for participants, and extend the annual lump sum participation bonus for an additional two years.

 

Burgess Reintroduces GOLD CARD Act

Rep. Michael C. Burgess, MD (R-Texas) has reintroduced the Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act (H.R. 4968). The bill would exempt qualifying providers from prior authorization requirements under Medicare Advantage (MA) plans. The exemption would apply to providers who had at least 90% of prior authorization requests approved the preceding year. In related news, the Improving Seniors’ Timely Access to Care Act was advanced by the House Ways and Means Committee as a part of the Health Care Price Transparency Act last week. The measure would modernize the use of prior authorization in the MA program by establishing an electronic prior authorization process, requiring the U.S. Department of Health and Human Services to establish a process for real-time decisions for items and services that are routinely approved, and requiring MA plans to report on the extent of their use of prior authorization and their rate of approvals or denials.

 

Democrats Introduce Bill to Expand IRA Drug Pricing Provisions

House Democratic committee leaders introduced legislation (H.R. 4895) last week that aims to expand the impact of the Inflation Reduction Act’s drug pricing provisions. The Lowering Drug Costs for American Families Act would extend the drug price negotiation program to all Americans with private coverage, apply the law’s inflation rebates to individuals covered by private health plans, and increase the annual number of prescription drugs subject to negotiation from 20 to 50. The bill was introduced by Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-N.J.), Ways and Means Committee Ranking Member Richard E. Neal (D-Mass.), and Education and the Workforce Committee Ranking Member Robert C. “Bobby” Scott (D-Va.).

 

White House Releases Report on Compliance with Mental Health Parity Law

The Biden administration released a report to Congress last week on the state of compliance with the Mental Health Parity and Addiction Equity Act. It is the first time that such a report names the health insurance plans that are failing to meet the requirements of the law. Six categories of compliance problems are identified in the report, including prior authorization requirements for in-network and out-of-network inpatient services; concurrent care review for in-network and out-of-network inpatient and outpatient services; standards for provider admission to participate in a network; out-of- network reimbursement rates and how they were determined; impermissible exclusions of key treatments for mental health conditions; and adequacy standards for mental health provider networks. The report also includes examples of corrective actions plans have taken to address their deficiencies. The report was released in conjunction with a new proposed rule to strengthen the standards for health plans to meet the requirements of the mental health parity statute.

 

ARPA-H Launches Cancer Surgery Program

The Advanced Research Projects Agency for Health is seeking proposals for its first cancer focused program dubbed Precision Surgical Interventions (PSI). PSI aims to help all surgical procedures reach their intended goal with no errors and no need for re-operation. It will work toward developing solutions to two major surgical problems: tumor edge visualization and critical anatomy visualization. Proposer’s Day for interested researchers will open September 7.

 

Recently Introduced Health Legislation

H.R.4822 – To improve price transparency with respect to certain health care services, and for other purposes; Sponsor: Smith, Jason [Rep.-R-MO-8]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Budget

 

H.R.4827 – To require applications for a health profession opportunity grant under section 2008 of the Social Security Act to contain evidence of in-demand jobs or worker shortages; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Ways and Means

 

H.R.4828 – To amend title XVIII of the Social Security Act to promote price transparency for imaging tests under the Medicare program; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4829 – To amend the Public Health Service Act to provide for the participation of physical therapists in the National Health Service Corps Loan Repayment program, to amend title XVIII of the Social Security Act to expand Medicare Rural Health Clinic Services and Federally Qualified Health Center Services to include physical therapy services, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4830 – To establish an interactive online dashboard to improve public access to information about grant funding related to mental health and substance use disorder programs; Sponsor: Gonzales, Tony [Rep.-R-TX-23]; Committees: House – Energy and Commerce

 

H.R.4832 – To amend the Indian Self-Determination Act and the Indian Health Care Improvement Act to provide advance appropriations authority for certain accounts of the Bureau of Indian Affairs and Bureau of Indian Education of the Department of the Interior and the Indian Health Service of the Department of Health and Human Services, and for other purposes; Sponsor: McCollum, Betty [Rep.-D-MN-4]; Committees: House – Natural Resources; Energy and Commerce; Education and the Workforce; Budget

 

H.R.4833 – To provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy, childbirth, or post-partum, under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Moore, Gwen [Rep.- D-WI-4]; Committees: House – Ways and Means

 

H.R.4837 – To amend the Public Health Service Act to help build a stronger health care workforce; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4839 – To amend title XVIII of the Social Security Act to require certain facilities under the Medicare program to disclose certain information relating to charges and prices; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means; Energy and Commerce

 

S.2459 – A bill to amend title XVIII of the Social Security Act to ensure appropriate supervision requirements for outpatient physical therapy and outpatient occupational therapy, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2464 – A bill to amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2465 – A bill to require the Secretary of Veterans Affairs to establish a pilot program to furnish doula services to veterans; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Veterans’ Affairs

 

S.2474 – A bill to amend title XVIII of the Social Security Act to ensure appropriate cost-sharing for chronic care drugs under Medicare part D; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Finance

 

S.2476 – A bill to amend the Public Health Service Act to provide for a behavioral and mental health outreach and education strategy to reduce stigma associated with mental health among the Hispanic and Latino population, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2477 – A bill to amend title XVIII of the Social Security Act to provide pharmacy payment of certain services; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.2481 – A bill to amend title XIX of the Social Security Act to encourage appropriate prescribing under Medicaid for victims of opioid overdose; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.2483 – A bill to amend the Public Health Service Act to provide additional transparency and consumer protections relating to medical debt collection practices; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2485 – A bill 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: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Banking, Housing, and Urban Affairs

 

S.2493 – A bill to require the Medicare Payment Advisory Commission (MedPAC) submit to Congress two reports on arrangements with pharmacy benefit managers with respect to prescription drug plans MA-PD plans; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

H.R.4846 – To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4849 – To allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Energy and Commerce

 

H.R.4851 – To provide for improvements in the implementation of the National Suicide Prevention Lifeline, and for other purposes; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Veterans’ Affairs; Oversight and Accountability

 

H.R.4874 – To provide for technical assistance under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Ways and Means

 

H.R.4878 – To amend title XVIII of the Social Security Act to ensure appropriate supervision requirements for outpatient physical therapy and outpatient occupational therapy; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4881 – To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; Sponsor: Malliotakis, Nicole [Rep.-R-NY-11]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4882 – To amend title XVIII of the Social Security Act to promote laboratory price transparency under the Medicare program; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4883 – To amend title XVIII of the Social Security Act to require the disclosure of certain ownership information relating to health care provider and pharmacy ownership, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R- NC-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4884 – To amend the Public Health Service Act to provide for a behavioral and mental health outreach and education strategy to reduce stigma associated with mental health among the Hispanic and Latino population, and for other purposes; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.4885 – To improve training requirements for health profession opportunity grant programs and exclude assistance provided by those programs from income tax, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Ways and Means

 

H.R.4886 – To provide for a study by the National Academies of Sciences, Engineering, and Medicine on the prevalence and mortality of cancer among individuals who served as active duty aircrew in the Armed Forces, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Veterans’ Affairs

 

H.R.4892 – To amend title XIX of the Social Security Act to provide a higher Federal matching rate for increased expenditures under Medicaid for behavioral health services (including those related to mental health and substance use), and for other purposes; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

S.2510 – A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2511 – A bill to expand psychological mental and behavioral health services to Medicare, Medicaid, and CHIP beneficiaries by permitting reimbursement of psychological services provided by certain supervised psychology trainees, and facilitating the reimbursement of those services; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

S.2536 – A bill to require the Secretary of Agriculture to provide training materials for the use of health care professionals to inform their patients about the availability of benefits under the supplemental nutrition assistance program, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Agriculture, Nutrition, and Forestry

 

S.2538 – A bill to authorize the Secretary of Health and Human Services to award grants to regional biocontainment laboratories for maintaining surge capacity for purposes of responding to outbreaks of infectious diseases or acts of bioterrorism; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2539 – A bill to clarify that, in awarding funding under title X of the Public Health Service Act, the Secretary of Health and Human Services may not discriminate against eligible States, individuals, or other entities for refusing to counsel or refer for abortions; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2544 – A bill to amend the Public Health Service Act to improve reproductive health care of individuals with disabilities; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4895 – To amend title XI of the Social Security Act to expand the drug price negotiation program, and for other purposes; Sponsor: Pallone, Frank, Jr. [Rep.-D-NJ-6]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4901 – To amend the Public Health Service Act to improve reproductive health care of individuals with disabilities; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce

 

H.R.4905 – To amend the Internal Revenue Code of 1986, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to promote group health plan price transparency; Sponsor: Fitzpatrick, Brian K. [Rep.-R- PA-1]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.4911 – To provide for the establishment of a pilot program to provide grants to community mental health centers for the placement of social workers with law enforcement agencies, and for other purposes; Sponsor: Harder, Josh [Rep.-D- CA-9]; Committees: House – Judiciary

 

H.R.4914 – To provide for research and improvement of cardiovascular health among the South Asian population of the United States, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce

 

H.R.4917 – To amend title XVIII of the Social Security Act to provide no-cost coverage for PFAS testing under the Medicare program; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4918 – To authorize the Secretary of Health and Human Services to provide grants to medical and other health profession schools to expand or develop education and training programs for substance use prevention and treatment, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House – Energy and Commerce

 

H.R.4930 – To provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy, childbirth, or post-partum, under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Moore, Gwen [Rep.- D-WI-4]; Committees: House – Ways and Means

 

H.R.4933 – 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: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.4941 – To amend title V of the Public Health Service Act to establish within the Substance Abuse and Mental Health Services Administration a Center for Unhoused Individuals, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D- CA-30]; Committees: House – Energy and Commerce

 

H.R.4942 – To provide incentives to physicians to practice in rural and medically underserved communities, and for other purposes; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Judiciary

 

H.R.4946 – To amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare Program; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Ways and Means

 

H.R.4950 – To amend title XIX of the Social Security Act to encourage appropriate prescribing under Medicaid for victims of opioid overdose; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

S.Res.319 – A resolution declaring racism a public health crisis; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.323 – A resolution supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2023; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2556 – A bill to amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2559 – A bill to amend the Internal Revenue Code of 1986 to establish a stewardship fee on the production and importation of opioid pain relievers, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.2560 – A bill to address and support research on Long COVID; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2569 – A bill to amend the Controlled Substances Act to clarify that the possession, sale, purchase, importation, exportation, or transportation of drug testing equipment that tests for the presence of fentanyl or xylazine is not unlawful; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary

 

S.2580 – A bill to support programs for mosquito-borne and other vector-borne disease surveillance and control; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2584 – A bill to establish a commission on long-term care; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2586 – A bill to address prescription drug shortages and improve the quality of prescription drugs, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2590 – A bill to amend the Public Health Service Act to provide additional funding for the Commissioned Corps of the Public Health Service; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2602 – A bill to limit the scope of regulations issued by the Secretary of Health and Human Services to control communicable diseases, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2617 – A bill to prohibit the Secretary of Health and Human Services from restricting direct access by health care facilities to medical countermeasures; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2621 – A bill to amend the Internal Revenue Code of 1986 to expand and improve health savings accounts, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Finance

 

S.2622 – A bill to clarify the application of the appointment and confirmation requirements for the Director of the Centers for Disease Control and Prevention; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2624 – An original bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Appropriations

 

S.2638 – A bill to authorize the Secretary of Health and Human Services to build safer, thriving communities, and save lives, by investing in effective community-based violence reduction initiatives, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.2639 – A bill to amend the Public Health Service Act to require the Secretary of Health and Human Services to carry out activities to establish, expand, and sustain a public health nursing workforce, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2644 – A bill to establish standards for trauma kits purchased using funds provided under the Edward Byrne Memorial Justice Assistance Grant Program; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary

 

S.2645 – A bill to reduce the health risks of heat by establishing the National Integrated Heat Health Information System within the National Oceanic and Atmospheric Administration and the National Integrated Heat Health Information System Interagency Committee to improve extreme heat preparedness, planning, and response, requiring a study, and establishing financial assistance programs to address heat effects, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Commerce, Science, and Transportation

 

S.2646 – A bill to expand access to health care services for immigrants by removing legal and policy barriers to health insurance coverage, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.2647 – A bill to improve research and data collection on stillbirths, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2649 – A bill to improve community care provided by the Department of Veterans Affairs, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.2650 – A bill to establish a Commission on the Federal Regulation of Cannabis to study a prompt and plausible pathway to the Federal regulation of cannabis, and for other purposes; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Judiciary

 

S.2657 – A bill to provide for green and resilient health care infrastructure, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2665 – A bill 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: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Armed Services

 

S.2666 – A bill 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 requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2672 – A bill to require the Secretary of Health and Human Services to develop a strategic framework to improve the development and distribution of diagnostic tests in response to chemical, biological, radiological, or nuclear threats; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2683 – A bill to establish requirements for purchasing certain generic drugs from manufacturers who produce the drug domestically; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2684 – A bill to amend title XI of the Social Security Act to require the Secretary of Health and Human Services to verify whether a health care provider is licensed in good standing before issuing the provider a unique health identifier, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Finance

 

S.2686 – A bill to require the Comptroller General of the United States to conduct a study on the economic impact and health outcomes associated with the response to the COVID-19 pandemic in the United States; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2688 – A bill to amend the Public Health Service Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2699 – A bill to combat the fentanyl crisis; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2714 – A bill to establish the National Artificial Intelligence Research Resource, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Commerce, Science, and Transportation

 

H.Res.632 – Recognizing July 28, 2023, as “World Hepatitis Day”; Sponsor: Velazquez, Nydia M. [Rep.-D-NY-7]; Committees: House – Energy and Commerce

 

H.R.4953 – To reduce the health risks of heat by establishing the National Integrated Heat Health Information System within the National Oceanic and Atmospheric Administration and the National Integrated Heat Health Information System Interagency Committee to improve extreme heat preparedness, planning, and response, requiring a study, and establishing financial assistance programs to address heat effects, and for other purposes; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce; Science, Space, and Technology

 

H.R.4968 – To amend title XVIII of the Social Security Act to exempt qualifying physicians from prior authorization requirements under Medicare Advantage plans, and for other purposes; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4975 – To establish a grant to provide mental and behavioral health services and diversion programs to at-risk youth, and for other purposes; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Judiciary

 

H.R.4985 – To establish a grant program to support schools of medicine and schools of osteopathic medicine in underserved areas; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House – Energy and Commerce

 

H.R.4988 – To amend the Federal Food, Drug, and Cosmetic Act to modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain, and for other purposes; Sponsor: Davis, Donald G. [Rep.-D- NC-1]; Committees: House – Energy and Commerce

 

H.R.5002 – To direct the Secretary of Veterans Affairs to carry out a pilot program for the cognitive care of veterans, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Veterans’ Affairs

 

H.R.5003 – To authorize the Secretary of Health and Human Services to build safer, thriving communities, and save lives, by investing in effective community-based violence reduction initiatives, and for other purposes; Sponsor: Horsford, Steven [Rep.-D-NV-4]; Committees: House – Judiciary; Education and the Workforce

 

H.R.5007 – To provide for green and resilient health care infrastructure, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce

 

H.R.5008 – To expand access to health care services for immigrants by removing legal and policy barriers to health insurance coverage, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5010 – To require the Secretary of Health and Human Services, in coordination with the Director of the Centers for Disease Control and Prevention, to submit to the Congress an annual report on the effects of gun violence on public health; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce

 

H.R.5012 – To improve research and data collection on stillbirths, and for other purposes; Sponsor: Kim, Young [Rep.-R- CA-40]; Committees: House – Energy and Commerce

 

H.R.5013 – To direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5027 – To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5066 – To amend the Public Health Service Act to authorize grants to evaluate, develop, and expand the use of technology-enabled collaborative learning and capacity building models to improve maternal health outcomes, and for other purposes; Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce

Senate, House Make Progress on PAHPA Reauthorization

Lawmakers in both the Senate and the House of Representatives are working to advance legislation to reauthorize key pandemic preparedness programs before they expire at the end of the fiscal year. The Senate Health, Education, Labor, and Pensions (HELP) Committee and the House Energy and Commerce Committee each approved their respective Pandemic and All- Hazards Preparedness Act (PAHPA) reauthorization bills last week. While the Senate-version (S. 2333) garnered bipartisan support, Democrats on Energy and Commerce voted against the bills (H.R. 4420, H.R. 4421) during markup on Wednesday. They criticized the legislation for the absence of provisions to address the nation’s ongoing drug shortages. It is the first time that PAHPA reauthorization has not moved on a bipartisan basis through the House committee of jurisdiction. The Senate bill is broader in scope than the House proposal. It would require pharmaceutical manufacturers to notify the Food and Drug Administration about potential drug shortages stemming from increased demand for a product. It also includes a provision backed by HELP Chairman Bernie Sanders (I-Vt.) to study funding models for biomedical research that delink R&D costs from the price of a drug, as well as a proposal from Ranking Member Bill Cassidy (R-La.) to extend the priority review voucher program for five years.

 

E&C Advances Bipartisan SUPPORT Act Reauthorization

The House Energy and Commerce Committee unanimously advanced legislation (H.R. 4531) to reauthorize the SUPPORT for Patients and Communities Act, “landmark” legislation originally passed in 2018 to respond to the opioid crisis, before the program authorizations expire at the end of September. The legislation would also remove the institutions for mental disease (IMD) exclusion, which prohibits states from using Medicaid money to pay for substance use disorder treatment in large mental health institutions. It also includes proposals to bar states from unenrolling individuals from Medicaid while they are incarcerated awaiting trials, and to permanently require Medicaid coverage of every form of medication-assisted treatment. Xylazine would be scheduled as a Schedule III substance under the reauthorization bill, which would subject the drug to oversight by the Drug Enforcement Administration.

 

FY 2024 Appropriations Update

The Senate Appropriations Committee advanced its fiscal year (FY) 2024 State-Foreign Operations appropriations bill last week with bipartisan support. The legislation would increase funding for global health security to $900 million. This contrasts with the House version of the bill, which includes cuts to global health funding. The Senate bill also funds the Biden administration’s global health workforce initiative and appropriates $300 million for the vaccine alliance Gavi. The Global Fund to Fight AIDS and the President’s Malaria Initiative would receive a $1.65 billion contribution.

The House of Representatives is set to consider its FY 2024 Agriculture-Rural Development-Food and Drug Administration and Military Construction-Veterans Affairs appropriations bills on the floor this week. This would leave the remaining 10 annual spending bills for consideration in September. House leaders plan to pass each bill individually rather than combine them into an omnibus package. Appropriators in the Senate aim to complete their spending bill markups in July, but are not expected to consider any of the measures on the floor before the August recess.

 

HELP to Consider Sweeping Community Health Center, Workforce Package This Week

Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) released an $86 billion health care workforce and primary care package last week. The panel is scheduled to mark up the legislation on Wednesday. The bill would reauthorize and significantly increase funding for community health centers, providing $20 billion in annual spending for the Community Health Center Fund over the next five years. In addition to reauthorizing the National Health Service Corps (NHSC), the Teaching Health Center Graduate Medical Education (THCGME) program, and the Children’s Hospital Graduate Medical Education (CHGME) program, the bill includes site neutrality policies to bar hospitals from charging facility fees for services provided by off-site physicians, and prohibit such hospitals and physicians from billing separately for a service. A section-by-section summary of the bill can be found here.

Ranking Member Bill Cassidy (R-La.) has characterized the proposal as irresponsible legislating, criticizing the total amount of spending authorized by the package. Cassidy’s own reauthorization proposal mirrors the narrower measures advanced by the House Energy and Commerce Committee as a part of the PATIENT Act (H.R. 3561). The House measure reauthorizes the NHSC, THCGME program, and Community Health Center Fund, providing only a slight increase for community health centers from $4 billion to $4.2 billion annually for the next two years.

 

House VA Panel Advances Health Legislation

The House Veterans’ Affairs Subcommittee on Health forwarded a slate of health-related bills last week. The Expanding Veterans’ Options for Long Term Care Act (H.R. 1815) would create a three-year pilot program to offer assisted living to veterans who are not eligible for nursing home care. The VA Zero Suicide Demonstration Project Act (H.R. 1639) would establish the Zero Suicide Initiative pilot program to improve veteran safety and suicide care. The Veteran Care Improvement Act (H.R. 3520) aims to increase access to and transparency around community care outside the VA. The VA Emergency Transportation Act (H.R. 1774) would mandate that veterans be reimbursed for emergency transportation delivered by non-VA providers. The bills will now advance to the full committee for consideration. They could potentially be included in a bipartisan veterans’ health care package being drafted in the Senate.

 

E&C Republicans Probe FDA Foreign Drug Manufacturing

Republicans on the House Energy and Commerce Committee are asking Administrator of Food and Drugs Robert Califf for information about his agency’s foreign drug inspections in India and China. The lawmakers express concern that the nation is “overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.” The letter was signed by Republican members of the Health and Oversight and Investigations subcommittees. They request details from Califf about the FDA’s foreign inspection activities by August 1.

 

Lawmakers Continue Push for PEPFAR Reauthorization

Abipartisan group of 75 members of Congress have sent a letter to the State Department expressing support for the reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) and highlighting the urgency of continuing to address mother-to-child HIV transmission. The lawmakers specifically discuss the potential of reviving the Saving Mothers, Giving Life program – an Obama administration-era pilot program that successfully reduced maternal mortality and prevented vertical HIV transmission. The letter, led by Reps. Mike Lawler (R-N.Y.) and Abigail Spanberger (D-Va.), follows a similar bipartisan letter sent by members on the Senate last month.

 

Upcoming Congressional Hearings and Markups

Senate Judiciary Subcommittee on Privacy, Technology, and the Law hearing “Oversight of A.I.: Principles for Regulation;” 3:00 p.m.; July 25

 

Senate Homeland Security and Governmental Affairs Committee business meeting to consider 21 bills, including AI and cybersecurity related legislation; 9:00 a.m.; July 26

 

Senate Health, Education, Labor, and Pensions Committee markup of S.__, The Primary Care and Health Workforce Expansion Act; 10:30 a.m.; July 26

 

Senate Homeland Security and Governmental Affairs Committee hearing “Governing AI Through Acquisition and Procurement;” 11:00 a.m.; July 26

 

Senate Judiciary Subcommittee on Intellectual Property hearing “Oversight of the United States Patent and Trademark Office;” 2:30 p.m.; July 26

 

Senate Veterans’ Affairs Committee hearing “Implementing the PACT Act: One Year Later;” 3:00 p.m.; July 26

 

House Judiciary Committee hearing “The Dangers and Due Process Violations of ‘Gender-Affirming Care’ for Children;” 10:00 a.m.; July 27

 

House Judiciary Subcommittee on Crime and Federal Government Surveillance hearing “Oversight of the Drug Enforcement Administration;” 10:00 a.m.; July 27

 

House Oversight and Accountability hearing “Oversight and Reauthorization of the Office of National Drug Control Policy;” 10:00 a.m.; July 27

 

Joint Economic Committee hearing to examine the economic impact of diabetes; 2:00 p.m.; July 27

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Because I Said So: Examining the Science and Impact of COVID-19 Vaccine Mandates;” 2:00 p.m.; July 27

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “Hemp in the Modern World: The Yearlong Wait for FDA Action;” 2:00 p.m.; July 27

 

House Natural Resources Subcommittee on Indian and Insular Affairs hearing on H.R. ___, Restoring Accountability in the Indian Health Service Act of 2023; 2:15 p.m.; July 27

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.4638 – To amend title XVIII of the Social Security Act to revise the definition of the term clinical social worker services. Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4646 – To reauthorize the rural emergency medical service training and equipment assistance program, and for other purposes. Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Energy and Commerce

 

H.Res.594 – Recognizing the value of the Older Americans Act of 1965 nutrition program in addressing hunger, malnutrition, and isolation, and improving the health and quality of life for millions of our Nations seniors each year; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Education and the Workforce

 

H.R.4680 – To amend title XVIII of the Social Security Act to extend the period for certain teaching hospitals to establish full-time equivalent residency caps for new residency training programs impacted by the COVID-19 pandemic, and for other purposes; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4692 – 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: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Energy and Commerce

 

H.R.4697 – To amend the Public Health Service Act to reauthorize certain programs with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response and certain programs with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce

 

H.R.4699 – To establish within the Department of Health and Human Services a Division on Community Safety, and for other purposes; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Judiciary; Energy and Commerce; Transportation and Infrastructure; Financial Services; Education and the Workforce

 

H.R.4701 – To codify the temporary scheduling order for fentanyl-related substances by adding fentanyl-related substances to schedule I of the Controlled Substances Act; Sponsor: D’Esposito, Anthony [Rep.-R-NY-4]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4702 – To require the Secretary of Health and Human Services to prescribe a regulation reducing the risks in gene synthesis products, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.4703 – To require research into the health consequences of the environmental impacts of nuclear war, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.4704 – To require the Assistant Secretary for Preparedness and Response shall conduct risk assessments and implement strategic initiatives or activities to address threats to public health and national security due to technical advancements in artificial intelligence or other emerging technology fields; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.4710 – To require the Director of the Centers for Disease Control and Prevention to accelerate the collection and publication of data on suicide and drug overdoses; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce

 

H.R.4712 – To provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4713 – To codify the Rural Hospital Technical Assistance Program of the Department of Agriculture; Sponsor: Jackson, Ronny [Rep.-R-TX-13]; Committees: House – Agriculture

 

H.R.4714 – To amend the Public Health Service Act to authorize the Director of the National Institutes of Health to make awards to outstanding scientists, including physician-scientists, to support researchers focusing on pediatric research, including basic, clinical, translational, or pediatric pharmacological research, and for other purposes; Sponsor: Joyce, John [Rep.-R-PA-13]; Committees: House – Energy and Commerce

 

S.2372 – A bill to amend title XIX of the Social Security Act to streamline enrollment under the Medicaid program of certain providers across State lines, and for other purposes; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Finance

 

S.2374 – A bill to exclude certain individuals subject to certain deferred action from eligibility for health plans offered on the Exchanges, advance payments of the premium tax credit, cost-sharing reductions, a Basic Health Program, and for Medicaid and the Children’s Health Insurance Programs, and for other purposes; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Finance

 

S.2377 – A bill to amend title XVIII of the Social Security Act to improve coverage of audiology services under the Medicare program, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Finance

 

S.2379 – A bill to amend title XVIII of the Social Security Act to provide for certain cognitive impairment detection in the Medicare annual wellness visit and initial preventive physical examination; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Finance

 

S.2383 – A bill to amend the Clean Air Act to establish a grant program for supporting local communities in detecting, preparing for, communicating about, or mitigating the environmental and public health impacts of wildlife smoke and extreme heat, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Environment and Public Works

 

S.2386 – A bill to require health insurance coverage for the treatment of infertility; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2397 – A bill to amend section 495 of the Public Health Service Act to require inspections of foreign laboratories conducting biomedical and behavioral research to ensure compliance with applicable animal welfare requirements, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2398 – A bill to require research into the health consequences of the environmental impacts of nuclear war, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2399 – A bill to require the Assistant Secretary for Preparedness and Response to conduct risk assessments and implement strategic initiatives or activities to address threats to public health and national security due to technical advancements in artificial intelligence or other emerging technology fields; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2400 – A bill to require the Secretary of Health and Human Services to prescribe a regulation reducing the risks in gene synthesis products, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.603 – Supporting the ideals of Bump Day, a global day of maternal health awareness, action and advocacy, and reaffirming United States leadership to end preventable maternal deaths in the United States and globally; Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House – Energy and Commerce

 

H.R.4726 – To terminate the COVID-19 vaccination requirement for aliens, and for other purposes; Sponsor: Massie, Thomas [Rep.-R-KY-4]; Committees: House – Judiciary; Energy and Commerce

 

H.R.4727 – To exclude certain individuals subject to certain deferred action from eligibility for health plans offered on the Exchanges, advance payments of the premium tax credit, cost-sharing reductions, a Basic Health Program, and for Medicaid and the Children’s Health Insurance Programs, and for other purposes; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4730 – To provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals with an arrest or conviction record to enter and follow a career pathway in the health professions through occupations that are expected to experience a labor shortage or be in high demand, under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Ways and Means

 

H.R.4731 – To require health insurance coverage for the treatment of infertility; Sponsor: DeLauro, Rosa L. [Rep.-D- CT-3]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Oversight and Accountability; Veterans’ Affairs; Armed Services

 

H.R.4732 – To ensure that health professions opportunity demonstration projects train project participants to earn a recognized postsecondary credential, and to clarify that community colleges are eligible for grants to conduct such a demonstration project; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Ways and Means

 

H.R.4733 – To amend the Clean Air Act to establish a grant program for supporting local communities in detecting, preparing for, communicating about, or mitigating the environmental and public health impacts of wildfire smoke and extreme heat, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce; Science, Space, and Technology

 

H.R.4734 – To require preference to be given to applicants for health profession opportunity grants under section 2008 of the Social Security Act who have certain kinds of business and community partners; Sponsor: Evans, Dwight [Rep.-D- PA-3]; Committees: House – Ways and Means

 

H.R.4735 – To provide for the use of peer support, peer mentoring, and career coaching in demonstration projects conducted under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Evans, Dwight [Rep.-D-PA-3]; Committees: House – Ways and Means

 

H.R.4736 – To amend the Consolidated Farm and Rural Development Act to provide support for facilities providing healthcare, education, child care, public safety, and other vital services in rural areas; Sponsor: Fischbach, Michelle [Rep.- R-MN-7]; Committees: House – Agriculture

 

H.R.4752 – To amend title XVIII of the Social Security Act to provide for certain cognitive impairment detection in the Medicare annual wellness visit and initial preventive physical examination; Sponsor: Sánchez, Linda T. [Rep.-D-CA-38]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4753 – To ensure an evidence-based funding approach to study the effects of health profession opportunity grant demonstration projects, and to evaluate the demonstration projects; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means

 

H.R.4757 – To amend the Public Health Service Act to prohibit the National Institutes of Health from awarding any support for an activity or program that uses live animals in research unless the research occurs in the United States, and for other purposes; Sponsor: Titus, Dina [Rep.-D-NV-1]; Committees: House – Energy and Commerce

 

H.R.4758 – To amend title XIX of the Social Security Act to streamline enrollment under the Medicaid program of certain providers across State lines, and for other purposes; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Energy and Commerce

 

S.2404 – A bill to improve the operation of the Organ Procurement and Transplantation Network; Sponsor: Young, Todd [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2405 – A bill to amend title XVIII of the Social Security Act to assure pharmacy access and choice for Medicare beneficiaries; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.2406 – A bill to amend title XVIII of the Social Security Act to improve oversight of formulary development and management under Medicare part D; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2407 – A bill to amend title XVIII of the Social Security Act to provide for the coordination of programs to prevent and treat obesity, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2408 – A bill to amend title XVIII of the Social Security Act to provide for patient-focused listening sessions to improve prescription drug plan transparency, access, and choice; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Finance

 

S.2415 – A bill to amend title III of the Public Health Service Act to reauthorize Federal support of States in their work to save and sustain the health of mothers during pregnancy, childbirth, and the postpartum period, to eliminate disparities in maternal health outcomes for pregnancy-related and pregnancy-associated deaths, to identify solutions to improve health care quality and health outcomes for mothers, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2418 – A bill 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: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Finance

 

S.2427 – A bill 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 permit enrollees to obtain a 365-day supply of contraceptives; Sponsor: Fetterman, John [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2429 – A bill to amend title XIX of the Social Security Act to increase the ability of Medicare and Medicaid providers to access the National Practitioner Data Bank for the purpose of conducting employee background checks; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

S.2432 – A bill to amend the Food and Nutrition Act of 2008 to expand the medical expense deduction, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Agriculture, Nutrition, and Forestry

 

S.2433 – A bill to reauthorize certain programs under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2434 – A bill to amend the Public Health Service Act to continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2436 – A bill to amend title XVIII of the Social Security Act to assure pharmacy access and choice for Medicare beneficiaries; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance.

 

S.2439 – A bill to establish a grant program to fund reproductive health patient navigators for individuals seeking abortion services; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2444 – A bill to establish an interactive online dashboard to improve public access to information about grant funding related to mental health and substance use disorder programs; Sponsor: Fischer, Deb [Sen.-R-NE]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2447 – A bill to reauthorize the distance learning and telemedicine grant program, and for other purposes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Agriculture, Nutrition, and Forestry

 

S.2448 – A bill to establish a grant to provide mental and behavioral health services and diversion programs to at-risk youth, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.2454 – A bill to require reports on and investments in pharmaceutical supply chain resiliency to reduce reliance on the People’s Republic of China for finished pharmaceutical products and active pharmaceutical ingredients; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Foreign Relations

 

S.2456 – A bill to amend title XVIII of the Social Security Act to limit beneficiary cost-sharing to the net price of covered part D drugs; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

H.R.4771 – To amend title XXI of the Social Security Act to permanently extend the Children’s Health Insurance Program, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce

 

H.R.4775 – To amend title XIX and XXI of the Social Security Act to provide coverage of comprehensive tobacco cessation services under such titles, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.4779 – To amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast prostheses following a mastectomy; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4788 – To make opioid treatment programs eligible for grants under section 2008 of the Social Security Act; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Ways and Means

 

H.R.4794 – To amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts, flexible spending arrangements, and health reimbursement arrangements for dietary supplements; Sponsor: LaHood, Darin [Rep.- R-IL-16]; Committees: House – Ways and Means

 

H.R.4796 – To establish a grant program to fund reproductive health patient navigators for individuals seeking abortion services; Sponsor: Lee, Susie [Rep.-D-NV-3]; Committees: House – Energy and Commerce

 

H.R.4803 – To amend the Internal Revenue Code of 1986 to expand and improve health savings accounts, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Ways and Means

 

H.R.4813 – To require geographical diversity in the provision of health profession opportunity grants under section 2008 of the Social Security Act, and to require the support services provided through the use of the grants to include a transportation assistance plan; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means

 

H.R.4815 – To amend the Food and Nutrition Act of 2008 to expand the medical expense deduction, and for other purposes; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Agriculture

 

H.R.4816 – 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 permit enrollees to obtain a 365-day supply of contraceptives; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4818 – To amend title XVIII of the Social Security Act to provide for the coordination of programs to prevent and treat obesity, and for other purposes; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

House Appropriators Advance Labor-HHS, State- Foreign Ops Funding Bills

The House Appropriations Committee released its Labor-Health and Human Services-Education appropriations bill for fiscal year (FY) 2024 and advanced the package out of subcommittee last week. The bill would cut topline spending levels by 29%, with the U.S. Department of Health and Human Services (HHS) receiving a total of $103.3 billion – $14 billion less than current levels. Funding for the Centers for Disease Control and Prevention would be cut by $1.6 billion, funding for the National Institutions of Health would be cut by $3.8 billion, and funding for the Advanced Research Projects Agency for Health would be cut by $1 billion. Appropriations for the Agency for Healthcare Research and Quality would be eliminated altogether, with appropriators arguing the agency is duplicative of other HHS programs. Title X family planning grants would also be eliminated. The bill includes several contentious policy riders, including a requirement that HHS report to Congress how many abortions are provided under exceptions to the Hyde Amendment. The Senate Appropriations Committee is reportedly planning to mark up its own Labor-HHS-Education appropriations bill on July 27.

The House Appropriations Committee also approved its FY 2024 State and Foreign Operations appropriations bill last week. The bill includes a total of $1.5 billion for USAID, an approximately $500 million cut, and would extend authorization for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for one year. It includes a provision to prevent the administration from entering any international agreement via the World Health Assembly without two-thirds Senate approval. It also includes several abortion- related riders, including the Helms amendment restriction on the use of global health funds to pay for abortions and the Mexico City Policy barring support for organizations that perform or promote abortions. The Senate Appropriations Committee is scheduled to markup its FY 2024 State and Foreign Operations appropriations bill on July 20.

 

Education Workforce Panel Considers Health Transparency Measures

The House Education and Workforce Committee advanced four bipartisan health care transparency measures out of committee last week. The bills approved by the panel include:

  • H.R. 4509, the Transparency in Billing Act, which would require accurate billing practices by hospitals to ensure that group health plans pay for appropriately billed services.
  • H.R. 4507, the Transparency in Coverage Act, to codify the “Transparency in Coverage” final rule, which provides consumers with price transparency for medical services and prescription drugs.
  • H.R. 4527, the Health DATA Act, to ensure health plan fiduciaries are not contractually restricted from receiving cost or quality of care information about their plan.
  • H.R. 4508, the Hidden Fee Disclosure Act, which would strengthen requirements that pharmacy benefit managers and Third-Party Administrators disclose compensation to plan fiduciaries.

 

Finance Committee to Markup PBM Package

The Senate Finance Committee has scheduled a July 26 markup of legislative proposals to increase transparency and accountability in the pharmacy benefit manager (PBM) industry. While it remains unclear what legislation the package will contain, it is expected to build on the roadmap released by Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) in April outlining the types of bipartisan solutions they wished to pursue. The Chairman’s Mark will be released 48 hours in advance of the markup.

 

Senate Democrats Release Report on Generic Insulin Access

Senate Democrats released a report last week shedding light on the accessibility of generic insulin products. The report, which was prepared by the offices of Sens. Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), and Raphael Warnock (D-Ga.), found that while nearly half of the 300 pharmacies surveyed did not have Eli Lilly’s generic insulin Lispro in stock, 80% of those pharmacies had the more expensive brand product Humalog available. The average price of Lispro for uninsured individuals totaled $97.51, more than triple the advertised list price. The three major manufacturers of insulin – Eli Lilly, Novo Nordisk Inc., and Sanofi – publicly committed to limiting patient costs for generic insulin to $25 per vial earlier this year. Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sander (I-Vt.) met with Senate Majority Leader Chuck Schumer (D-N.Y.) to discuss the issue last week. Schumer has stated his intention to advance bipartisan legislation to lower the cost of insulin and prescription drugs during the chamber’s current work period.

 

Cassidy Releases Proposal to Reauthorize Key Health Programs

Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) has introduced legislation to reauthorize community health centers and several other public health programs. Cassidy’s proposal, which mirrors the bipartisan bill advanced by the House Energy and Commerce Committee, would offer small increases in funding for community health centers, the National Health Service Corps (NHSC), and the Teaching Health Center Graduate Medical Education (THCGME) Program. It stands in contrast to HELP Chairman Bernie Sander’s (I-Vt.) plan, which included significant funding increases. Authorization for the programs is set to expire at the end of the fiscal year on September 30. Cassidy’s Community Health Center Reauthorization Act would extend and increase funding for community health centers at $4.2 billion a year for the next two years. The Community Health Center Fund currently receives $4 billion in federal funding annually. The NHSC would be funded at $350 million for two years, an increase of $40 million per year. Funding for the THCGME program would increase from $175 million to $275 million over six years.

 

Senate Judiciary Advances Rogue Pharmacy Legislation

The Senate Judiciary Committee advanced bipartisan legislation last week to require social media companies and digital communication service providers to report to the Drug Enforcement Administration when their platforms are used by rogue pharmacies or drug dealers to illegally sell or distribute drugs. S. 1080, the Cooper Davis Act, was advanced in a 16-5 vote. The bill is named in honor of a 16-year-old teenager who died after taking a counterfeit prescription drug laced with fentanyl in August 2021. It was later discovered that a drug dealer solicited the teenager via Snapchat.

 

E&C GOP Investigation NIH Reappointments

Republican leadership of the House Energy and Commerce Committee are investigating the process surrounding the appointment of 14 National Institutes of Health (NIH) officials, including former National Institutes of Allergy and Infectious Diseases Director Anthony Fauci. The lawmakers assert that the individuals were not correctly reappointed to their positions in late 2021, calling into question the legality of the more than $25 billion in research grants they approved. While NIH center and institute leaders are permitted to serve multiple five-year terms, the 21st Century Cures Act requires the U.S. Department of Health and Human Services Secretary to personally handle such appointments. Chair Cathy McMorris Rodgers (R-Wash.) asserts that in the case of the 14 NIH leaders, reappointments were made by the NIH director and later ratified by Secretary Xavier Becerra. According to committee staff, the panel plans to continue pressing the issue with administration officials and are considering the need for legislation to clarify the appointment process.

 

Nomination for NIH Director Remains Stalled Before HELP Committee

Dr. Monica Bertagnolli, the White House’s nominee to lead the National Institutes of Health (NIH), has declined Sen. Elizabeth Warren’s (D-Mass.) request to make a public ethics pledge committing to not seek employment in an industry related to her government post for at least four years after leaving public service. Bertagnolli’s nomination also faces a hurdle from Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.), who has said he will oppose all administration health nominees who do not commit to working to lower drug prices. Bertagnolli reportedly has concerns about the scope of each commitment, and left a meeting with Warren last week without reaching an agreement. The NIH has been without a confirmed director for a year and a half, but administration officials have stated that they remain committed to Bertagnolli’s confirmation.

 

GAO Updates PHE Preparedness Recommendations

The Government Accountability Office (GAO) has released a new report containing additional recommendations for federal agencies to better prepare for future public health emergencies (PHE). As of April 2023, the GAO has made 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen response and preparedness. About 45% of those have been fully or partially addressed. GAO’s latest recommendations focus on access to diagnostic testing and medical countermeasures, access to real-time information about emerging threats, and the risk of improper payments and fraud.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health hearing “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology;” 10:30 a.m.; July 18

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “Why Expanding Medicaid to DACA Recipients Will Exacerbate the Border Crisis;” 2:00 p.m.; July 18

 

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

 

Joint Economic Committee hearing to examine the economic impact of diabetes; 2:00 p.m.; July 19

 

Senate Homeland Security and Governmental Affairs Committee hearing to examine America’s supply chain security, focusing on understanding and mitigating threats; 10:00 a.m.; July 20

 

Senate Finance Subcommittee on Health hearing “The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System;” 10:00 a.m.; July 20

 

Senate Health, Education, Labor, and Pensions Committee markup of S. ___, Pandemic and All-Hazards Preparedness and Response Act; 10:30 a.m.; July 20

 

Senate Appropriations Committee markup of FY 2024 State and Foreign Operations, Energy and Water Development, Housing, and Urban Development; 10:30 a.m.; July 20

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.4507 – To amend the Employee Retirement Income Security Act of 1974 to promote transparency in health coverage and reform pharmacy benefit management services with respect to 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.4508 – To amend the Employee Retirement Income Security Act of 1974 to clarify and strengthen the application of certain employer-sponsored health plan disclosure requirements; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Education and the Workforce

 

H.R.4509 – To amend the Employee Retirement Income Security Act of 1974 to require group health plans and health insurance issuers offering group health insurance coverage to only pay claims submitted by hospitals that have in place policies and procedures to ensure accurate billing practices, and for other purposes. Sponsor: Foxx, Virginia [Rep.-R- NC-5]; Committees: House – Education and the Workforce

 

H.R.4516 – To amend the Public Health Service Act to provide for the inclusion of a biological attribution strategy, and an early warning strategy and implementation plan, in the National Health Security Strategy, and for other purposes. Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

H.R.4518 – To amend title 38, United States Code, to modify the program of comprehensive assistance for family caregivers of veterans, and for other purposes. Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Veterans’ Affairs

 

H.R.4525 – To provide an individual with an eligible medical condition access to an employee restroom facilities of a retail establishment under certain conditions, and for other purposes. Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House – Energy and Commerce

 

S.2231 – A bill to amend title V of the Social Security Act to support stillbirth prevention and research, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Finance

 

S.2237 – A bill to amend the Public Health Service Act to require the Secretary to award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2239 – A bill to prevent maternal mortality and severe maternal morbidity among Black pregnant and postpartum individuals and other underserved populations, to provide training in respectful maternity care, to reduce and prevent bias, racism, and discrimination in maternity care settings, and for other purposes; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2243 – A bill to amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2245 – A bill to require a review of women and lung cancer, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2246 – A bill to authorize the appropriation of funds to the National Institutes of Health and the Centers for Disease Control and Prevention for conducting or supporting research on barriers to gender affirming care; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4527 – To amend the Employee Retirement Income Security Act of 1974 to ensure plan fiduciaries may access de- identified information relating to health claims, and for other purposes; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Education and the Workforce

 

H.R.4529 – To amend the Public Health Service Act regarding guidance documents of the Centers for Disease Control and Prevention, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.4531 – To reauthorize certain programs that provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Judiciary; Education and the Workforce

 

H.R.4534 – To require a review of women and lung cancer, and for other purposes; Sponsor: Boyle, Brendan F. [Rep.-D- PA-2]; Committees: House – Energy and Commerce

 

H.R.4535 – To amend the Internal Revenue Code of 1986 to increase funding for Social Security and Medicare; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Ways and Means

 

H.R.4541 – To improve the identification and support of children and families who experience trauma; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Education and the Workforce; Energy and Commerce; Judiciary

 

S.2254 – A bill to amend title XVIII of the Social Security Act to establish pharmacy benefit manager reporting requirements with respect to prescription drug plans and MA-PD plans under Medicare part D; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.2259 – A bill to require the Secretary of Veterans Affairs to carry out a pilot program to establish community integration network infrastructure for services for veterans, to require the collection from veterans of information related to social determinants of health, and for other purposes; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate – Veterans’ Affairs

 

S.2263 – A bill to require the Secretary of Veterans Affairs to reimburse the cost of transportation by ambulance for highly rural veterans seeking care under the laws administered by the Secretary, regardless of whether such veteran qualifies for payments or allowances for beneficiary travel; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate – Veterans’ Affairs

 

H.R.4572 – To provide for research and education with respect to uterine fibroids, and for other purposes; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.4581 – To amend title V of the Social Security Act to support stillbirth prevention and research, and for other purposes; Sponsor: Hinson, Ashley [Rep.-R-IA-2]; Committees: House – Energy and Commerce

 

H.R.4582 – To amend the Public Health Service Act to authorize the use of Preventive Health and Health Services Block Grants to purchase life-saving opioid antagonists for schools and to provide related training and education to students and teachers, and for other purposes; Sponsor: Lamborn, Doug [Rep.-R-CO-5]; Committees: House – Energy and Commerce

 

H.R.4585 – To amend title XIX of the Social Security Act to provide a higher Federal matching rate for increased expenditures under Medicaid for maternal health care services; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Energy and Commerce

 

S.2329 – A bill to establish an emerging pathogen preparedness program within the Food and Drug Administration to improve regulatory oversight of medical countermeasures for future pandemics. Sponsor: Hickenlooper, John W. [Sen.-D- CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2323 – A bill to amend title XVIII of the Social Security Act to provide for expanded coverage of services furnished by genetic counselors under part B of the Medicare program, and for other purposes. Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

S.2308 – A bill to extend funding for teaching health centers that operate GME programs, community health centers, and the National Health Service Corps. Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2305 – A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2304 – A bill to amend the Public Health Service Act to support dual or concurrent enrollment programs in allied health. Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2303 – A bill to provide for research and education with respect to uterine fibroids, and for other purposes. Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2300 – A bill to require that information on spending associated with national emergencies be subject to the same reporting requirements as other Federal funds under the Federal Funding Accountability and Transparency Act of 2006, and for other purposes. Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Homeland Security and Governmental Affairs

 

33. S.2297 – A bill to improve the provision of benefits and services to members of the Ready Reserve Corps of the Public Health Service, and for other purposes. Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2294 – A bill 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 those veterans and dependents were exposed to perfluorooctanoic acid or other perfluoroalkyl and polyfluoroalkyl substances, to provide for a presumption of service connection for certain veterans who were stationed at military installations at which those veterans were exposed to such substances, and for other purposes. Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.2293 – A bill to establish the Chief Artificial Intelligence Officers Council, Chief Artificial Intelligence Officers, and Artificial Intelligence Governance Boards, and for other purposes. Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.2288 – A bill to amend title XVIII of the Social Security Act to provide coverage of medically necessary home resiliency services under Medicare. Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

 

S.Res.294 – A resolution expressing support for the designation of May 2023 as “American Stroke Month”. Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4599 – To provide for the Secretary of Health and Human Services to establish grant programs to improve the health and positive youth development impacts of youth sports participation, and for other purposes; Sponsor: Allred, Colin Z. [Rep.-D-TX-32]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4603 – To provide for the prioritization of projects that provide behavioral and mental health treatment services in selecting grantees under certain rural development programs, and extend the substance abuse disorder set-aside and priority under the programs; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Agriculture

 

H.R.4605 – 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: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4623 – To establish a voluntary program to identify and promote internet-connected products that meet industry- leading cybersecurity and data security standards, guidelines, best practices, methodologies, procedures, and processes, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.4626 – To encourage sponsors of oral contraceptive drugs to submit applications for the approval of such drugs as over-the-counter, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce

White House Announces New ‘Bidenomics’ Initiatives

President Joe Biden announced a series of new administration initiatives aimed at lowering health care costs and strengthening patient protections on Friday. The announcements were the latest in a series of actions by the administration to push the President’s “Bidenomics” agenda and eliminate hidden junk fees. Friday’s releases included new proposed rules to reverse the Trump administration’s expansion of short-term, limited duration health plans. Democrats argue that such “junk” plans undermine the patient protections put in place by the Affordable Care Act. The new regulations would limit these plans to four months, instead of the current three-year maximum, and would require more disclosure around coverage limitations. The administration also released guidance intended to prevent health care providers from gaming the No Surprises Act’s regulations around surprise medical billing. The guidance would specifically limit the ability of insurers that contract with hospitals to claim provided care was not in network. It would also require insurers to disclose facility fees that are charged to patients. Finally, the administration announced a new effort being undertaken by the Consumer Financial Protection Bureau, the U.S. Department of Health and Human Services, and the Treasury Department to examine whether health care provider and third-party efforts to encourage consumers to sign up for medical credit cards and loans are operating outside of existing consumer protections and breaking the law.

 

Schumer Sends Dear Colleague on July Work Period

In a Dear Colleague letter on Sunday, Senate Majority Leader Chuck Schumer (D-N.Y.) previewed his agenda for the chamber’s upcoming work period following lawmakers’ return from the July 4th recess on Monday. In addition to considering bipartisan appropriations bills through regular order, Schumer hopes to advance bipartisan legislation to lower the cost of insulin and prescription drugs, combat the fentanyl crisis, and promote community health. He also announced his intention to build on his SAFE Innovation Framework for Artificial Intelligence (AI), which outlines how the Senate can advance American leadership in AI and harness its potential while protecting against potential harms. The Senate’s summer recess is currently scheduled to begin on July 31.

 

HELP Releases Bipartisan PAHPA Discussion Draft

Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee Bernie Sanders (I-Vt.) and Bill Cassidy (R-La.) released a staff-level agreement on a package to reauthorize the Pandemic and All- Hazards Preparedness Act (PAHPA) last week. While the lawmakers were able to reach a deal on much of the discussion draft to extend PAHPA authorities for five years, differences remain on several prescription drug pricing and drug development voucher provisions. Democrats are pushing to cap the cost of any product developed with the support of the Centers for Disease Control and Prevention or the Biomedical Advanced Research and Development Authority at the lowest price among G7 countries – U.S., U.K, Canada, France, Germany, Italy, and Japan. Republicans are seeking the reauthorization and expansion of the priority review voucher program at the Food and Drug Administration. The GOP proposal aims to incentivize the development of more medical countermeasures (MCMs) by providing a new, non- transferrable priority review voucher to companies that develop new MCMs on top of the transferrable voucher they currently receive, and by including threats to the Armed Forces within the program. HELP leadership sought feedback on their plan and the policies still under negotiation by July 10. Authorization for PAHPA’s public health programs expires on September 30.

 

CMS Proposes 340B Remedy Following Supreme Court Decision

The Centers for Medicare and Medicaid Services (CMS) is proposing to provide hospitals participating in the 340B drug program with $9 billion as compensation for $10.5 billion in payment cuts dating back to 2018. CMS states that the higher payment rate for 340B hospitals that has been in place since 2022 will cover the remaining $1.5 billion. The Supreme Court ruled last year that cuts made to the 340B program by the U.S. Department of Health and Human Services – aimed at increasing payment accuracy and addressing hospital overspending – were unlawful because CMS did not fully survey the impacted hospitals’ costs for acquiring 340B-eligible drugs. The proposed rule released last week outlines a plan to distribute the money to the approximately 1,600 hospitals that were paid less due to the now-invalidated policy. The proposed lump sum approach would involve Medicare administrative contractors calculating how much each hospital will receive within 60 days, along with a 0.5% cut to non-drug items and services for all hospitals to keep the resolution budget neutral.

 

FDA Fully Approves Leqembi

The Food and Drug Administration (FDA) has granted full approval to the Alzheimer’s treatment Leqembi. The drug has been shown to modestly slow cognitive decline in the early stages of Alzheimer’s disease, but also comes with potentially life-threatening side effects. It is the first drug for slowing the progression of Alzheimer’s – and not just targeting its symptoms – to be granted full FDA approval. In its phase three clinical trial of 1,795 patients with mild cognitive impairment or early-stage Alzheimer’s, disease progression was slowed by 27% over an 18-month period. The FDA’s approval includes a boxed warning about the potential for brain swelling and hemorrhage, which can lead to seizures and death. Approximately 12.6 % of patients who received Leqembi in the clinical trial developed brain swelling, compared with 1.7% of those in the placebo group, and around 17% of the Leqembi group experienced brain bleeds, versus 9% in the placebo group. Three deaths have been linked to the drug. Leqembi is administered intravenously every two weeks and will carry a list price of $26,500 per year. Following the FDA’s approval of the drug, the Centers for Medicare and Medicaid Services (CMS) confirmed that it would provide coverage of Leqembi under the Medicare program. In keeping with its previously announced policy, CMS will mandate that physicians collect real-world evidence on the performance of the treatment through participation in a qualifying CMS-facilitated registry.

 

U.S. Maternal Mortality Rates Continue to Rise

U.S. maternal mortality rates have doubled over the last decade according to a new study published in the Journal of the American Medical Association last week. The estimated number of deaths per 100,000 live births increased from 12.7 deaths in 1999 to 32.2 deaths in 2019. States in the south saw the highest maternal death rates across all race and ethnicity groups, and black women had the highest median maternal death rate.

 

Upcoming Congressional Hearings and Markups

Senate HELP Subcommittee on Primary Health & Retirement Security hearing “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine;” 10:00 a.m.; July 11

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Proximal Origin of a Cover Up;” 10:00 a.m.; July 11

 

Senate Appropriations Committee hearing “Accelerating Breakthroughs: How the Special Diabetes Program Is Creating Hope for those Living with Type 1 Diabetes;” 10:00 a.m.; July 11

 

Senate Judiciary Subcommittee on Intellectual Property hearing “Artificial Intelligence and Intellectual Property – Part II: Copyright;” 3:00 p.m.; July 12

 

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.Res.564 – Supporting the goals and ideals of Alzheimer’s and Brain Awareness Month. Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce

 

H.Res.572 – Expressing support for the designation of the month of June 2023 as “National Post-Traumatic Stress Injury Awareness Month” and June 27, 2023, as “National Post-Traumatic Stress Injury Awareness Day”. Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.4395 – To amend the Energy Policy and Conservation Act to modify standards for water heaters, furnaces, boilers, and kitchen cooktops, ranges, and ovens, and for other purposes. Sponsor: Bice, Stephanie I. [Rep.-R-OK-5]; Committees: House – Energy and Commerce

 

H.R.4400 – To direct the Secretary of Veterans Affairs to conduct an independent review of the deaths of certain veterans by suicide, and for other purposes. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Veterans’ Affairs

 

H.R.4402 – To amend title XI of the Social Security Act to clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes. Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4408 – To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes. Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House – Energy and Commerce

 

H.R.4410 – To amend title XVIII of the Social Security Act to make the Medicare Savings Program available in all jurisdictions. Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce

 

H.R.4411 – To amend title XVIII of the Social Security Act to establish a floor in Medicare Advantage benchmark rates for regions with low Medicare fee-for-service penetration. Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR- At Large]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4412 – To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to award grants to States to implement a tick identification pilot program. Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Energy and Commerce

 

H.R.4413 – To provide for the issuance of a Lyme Disease Research Semipostal Stamp. Sponsor: Gottheimer, Josh [Rep.- D-NJ-5]; Committees: House – Oversight and Accountability; Energy and Commerce

 

H.R.4414 – To amend title X of the Public Health Service Act to prohibit requiring a recipient or subrecipient of funds to provide referrals for abortion, and for other purposes. Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce

 

H.R.4418 – To amend title 10, United States Code, to repeal the restriction on the use of funds and facilities of the Department of Defense for abortion care. Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House – Armed Services

 

H.R.4419 – To amend the Public Health Service Act with respect to the Public Health Emergency Medical Countermeasures Enterprise, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation Contd.

H.R.4420 – To reauthorize certain programs under the Public Health Service Act with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Protection, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.4421 – To reauthorize certain programs under the Public Health Service Act with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.4424 – To direct the Secretary of Veterans Affairs to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era, and for other purposes. Sponsor: LaLota, Nick [Rep.-R-NY-1]; Committees: House – Veterans’ Affairs

 

H.R.4431 – To amend the Omnibus Crime Control and Safe Streets Act of 1968 to provide for a pilot program under the Comprehensive Opioid Abuse Grant Program for local law enforcement agencies located in rural areas to purchase naloxone to prevent and reduce opioid overdose deaths, and for other purposes. Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House – Judiciary

 

H.R.4438 – To amend title XVIII of the Social Security Act to provide for coverage and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under part B of such title, and for other purposes. Sponsor: Salazar, Maria Elvira [Rep.-R- FL-27]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4449 – To establish the Commission on Strengthening the Domestic Pharmaceutical Supply Chain, and for other purposes. Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Energy and Commerce

 

H.R.4458 – To amend title III of the Public Health Service Act to provide for clarity with respect to the duration of contracts for procurement of supplies for the Strategic National Stockpile, and for other purposes. Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4459 – To amend title III of the Public Health Service Act to specify the duration of contracts, grants, cooperative agreements, or other transactions awarded or entered into with the Biomedical Advanced Research and Development Authority, and for other purposes. Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4473 – To amend title XVIII of the Social Security Act to provide for site neutral payment for cancer care services under part B of the Medicare program; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4489 – To amend the 21st Century Cures Act to clarify that grants for State and Tribal response to opioid use disorders may, at the discretion of the Secretary of Health and Human Services, also be used to address associated health conditions, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce

 

H.R.4490 – To amend the Controlled Substances Act to authorize pharmacies to deliver certain controlled substances to an administering practitioner in lieu of delivering such substances to the to the ultimate user, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4498 – To promote a 21st century artificial intelligence workforce; Sponsor: Soto, Darren [Rep.-D-FL-9]; Committees: House – Education and the Workforce; Science, Space, and Technology

Debate on Drug Shortages Continues Amidst PAHPA Reauthorization

The House Energy and Commerce Subcommittee on Health plans to move forward with a markup of legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) on July 13 despite an unresolved dispute over the exclusion of provisions to address the nation’s ongoing drug shortages in the must-pass package. On Friday, Rep. Richard Hudson (R-N.C.), a senior member of the House Energy and Commerce Committee who had taken the lead on soliciting stakeholder comments in preparation for the PAHPA reauthorization, introduced three separate bills (H.R. 4419, H.R. 4420, and H.R. 4421) which seek to reauthorize PAHPA-related programs. Democrats on the panel continue to push for the inclusion of drug shortage measures as a part of the reauthorization bill. Ranking Member Frank Pallone (D-N.J.) supports giving the Food and Drug Administration (FDA) new authorities to combat the shortages, arguing in a statement last week that the “initial PAHPA included a provision requiring FDA to prepare for shortage issues that might arise, and all previous reauthorizations have included FDA-related policy.” Republicans support a narrower reauthorization package, saying that it will ease the chances of passing a reauthorization bill before the current all-hazards and public health security programs expire on September 30. Committee Chair Cathy McMorris Rodgers (R-Wash.) is requesting information from stakeholders on current drug shortages as a separate matter, while Democrats are seeking assurance that any drug shortages bill be considered in must-pass legislation if it is not included in PAHPA reauthorization. Subcommittee Republicans are expected to attach a measure to reauthorize and expand the SUPPORT Act, passed in 2018 to combat the opioid crisis, as a part of the PAHPA reauthorization bill. According to Politico, lawmakers hope to then consider the reauthorization package before the full committee on either July 19 or July 27.

 

PEPFAR Reauthorization Complicated by Abortion Dispute

The issue of abortion is complicating congressional efforts to reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR). The program, created in 2003 under the George W. Bush administration, is credited with saving more than 25 million lives through its support of antiretroviral treatments and efforts to prevent HIV infections and strengthen health care systems across the globe. PEPFAR has historically enjoyed bipartisan support on Capitol Hill, but Democrats and Republicans are currently at odds about federal funding for HIV/AIDS prevention groups that also support access to abortion. Chair of the House Foreign Affairs Subcommittee on Global Health, Global Human Rights, and International Organizations Chris Smith (R-N.J.), who led the last PEPFAR reauthorization in 2018, has stated that he will not write another update for PEPFAR programs unless it includes a prohibition on funding for organizations that back abortion services. Democrats have characterized the inclusion of such a provision as a poison pill and argue that there is no evidence that PEPFAR funding has gone to providing or promoting abortion.

 

SCOTUS Issues Ruling Reversing Affirmative Action

The Supreme Court issued a decision last week to effectively end the use of affirmative action in the college admissions process. Justices ruled that these programs violate the Constitution’s equal protection clause, which bars racial discrimination by government entities. Justices Clarence Thomas, Samuel Alito, Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett joined the majority opinion written by Chief Justice John Roberts. In response to the historic ruling, U.S. Department of Health and Human Services Secretary Xavier Becerra issued a statement highlighting the impact of the court’s decision on the health care workforce. Becerra argues that people of color have been historically excluded from attending medical school, noting that there is still a “significant deficit” in the number of Black and Latino doctors and medical students. “We need more health workers, especially those who look like and share the experiences of the people they serve,” Becerra stated. “This ruling will make it even more difficult for the nation’s colleges and universities to help create future health experts and workers that reflect the diversity of our great nation. The health and wellbeing of Americans will suffer as a result.”

 

CBO Releases Score of Telehealth Expansion Act

The Congressional Budget Office estimates that the Telehealth Expansion Act (S. 1001/H.R. 1843) has a 10-year price tag of $5.05 billion, driven by lost revenue from income and payroll taxes associated with increased contributions to Health Savings Accounts. The bill would permanently allow high-deductible health plans to offer telehealth before enrollees hit their deductible. Plans are currently only able to do so through the end of 2024 under a COVID-era statute. While the legislation, which was advanced by the House Ways and Means Committee earlier this year, has some bipartisan support, many Democrats have argued against strengthening high deductible health plans and undermining Affordable Care Act patient protections. Democrats have also raised concerns about the bill’s potential cost.

 

CMS Releases Final Drug Price Negotiation Guidance

The Centers for Medicare and Medicaid Services (CMS) released its revised guidance on Friday detailing the rules of the road for implementation of the Inflation Reduction Act’s “Medicare Drug Price Negotiation Program.” The final guidance relaxes the proposed requirement that pharmaceutical manufacturers not disclose information about price negotiations. It also removes the confidentiality policy’s data destruction requirements. These changes will result in the government no longer considering such materials as confidential.

 

ARPA-H Office Director Discusses Health Science Futures Work

The Advanced Research Projects Agency for Health’s (ARPA-H) Health Science Futures Director Amy Jenkins previewed her office’s work in an interview with Politico last week. In describing the foundational breakthroughs the Health Science Futures Office aims to accomplish, Jenkins stressed that the work of ARPA-H will be disease agnostic and will focus on developing, scaling, and applying different types of solutions to any disease state. She also discussed ARPA’s goal of de-risking innovation through the exploration of multiple approaches to a problem. Jenkins anticipates that ARPA-H will eventually have around 80 program managers that issue frequent research solicitations – once every year and a half – with 20 or more solicitations expected in the next calendar year. ARPA-H is currently soliciting research proposals for its first program, Novel Innovations for Tissue Regeneration in Osteoarthritis. Proposals are due on July 28, 2023.

 

HHS Releases Smoking Cessation Framework

The U.S. Department of Health and Human Services (HHS) released a draft framework last week to support and accelerate smoking cessation efforts. The framework is intended to serve as a roadmap for strengthening collaboration both amongst federal agencies and with nonfederal stakeholders. HHS highlights the framework as a part of the Biden administration’s Cancer Moonshot, which aims to reduce cancer mortality by 50% within 25 years. Smoking is the largest single driver of cancer mortality, causing approximately 30% of all cancer deaths. The draft framework is organized around six goals:

  • Eliminate smoking-related and cessation-related disparities;
  • Increase awareness and knowledge of smoking and cessation;
  • Strengthen and sustain cessation services and supports;
  • Increase access to and coverage of comprehensive, evidence-based cessation treatment;
  • Expand public health surveillance of smoking and cessation behaviors and strengthen performance measurement and evaluation; and
  • Promote ongoing and innovative research to support and accelerate smoking cessation.
  • HHS is seeking public input on the framework by July 30.

 

Upcoming Congressional Hearings and Markups

Senate HELP Subcommittee on Primary Health & Retirement Security hearing “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine;” 10:00 a.m.; July 11

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Proximal Origin of a Cover Up;” 10:00 a.m.; July 11

 

Senate Appropriations Committee hearing “Accelerating Breakthroughs: How the Special Diabetes Program Is Creating Hope for those Living with Type 1 Diabetes;” 10:00 a.m.; July 11

 

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

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.Res.550 – Expressing the sense of the House of Representatives regarding the Centers for Medicare & Medicaid Services developing a mobility metric to guide providers in preventing mobility loss among hospitalized older adults. Sponsor: Houchin, Erin [Rep.-R-IN-9]; Committees: House – Energy and Commerce

 

H.Res.555 – Recognizing the importance of intersectionality for abortion access. Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

H.R.4315 – To amend title XVIII of the Social Security Act to protect beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate, safe, effective, patient-centered orthotic and prosthetic care; to reduce fraud, waste, and abuse with respect to orthotics and prosthetics; and for other purposes. Sponsor: Thompson, Glenn [Rep.-R- PA-15]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4324 – To amend the Federal Trade Commission Act to provide the Commission with notice and comment rulemaking authority respecting unfair or deceptive acts or practices and to provide for civil penalties for violations of such Act respecting unfair or deceptive acts or practices, and for other purposes. Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.4328 – To provide for establishment of the National Task Force on the Nursing Shortage. Sponsor: Costa, Jim [Rep.- D-CA-21]; Committees: House – Energy and Commerce

 

H.R.4329 – To provide enhanced funding for family planning services. Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce

 

H.R.4330 – To amend title 18, United States Code, to require serial numbers to be engraved on ammunition, and for other purposes. Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Judiciary

 

H.R.4331 – 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: Goldman, Daniel S. [Rep.-D-NY-10]; Committees: House – Energy and Commerce

 

H.R.4334 – To amend chapter 171 of title 28, United States Code, to allow suit against the United States for injuries and deaths of members of the Armed Forces caused by improper medical care, and for other purposes. Sponsor: Issa, Darrell E. [Rep.-R-CA-48]; Committees: House – Judiciary

 

H.R.4339 – To amend title XIX of the Social Security Act to ensure enhanced Federal funding made available to States under the Medicaid program is equitably distributed to political subdivisions. Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Energy and Commerce

 

H.R.4343 – To amend the National Organ Transplant Act to clarify the definition of valuable consideration, to clarify that pilot programs that honor and promote organ donation do not violate that Act, and for other purposes. Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.4345 – To protect the dignity of fetal remains, and for other purposes. Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

H.R.4347 – To amend title 18, United States Code, to provide increased penalties for mass killings involving machineguns or certain semiautomatic weapons, and for other purposes. Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Judiciary

 

H.R.4358 – To provide lawful permanent resident status and authorized dual intent for certain doctoral degree holders. Sponsor: Thanedar, Shri [Rep.-D-MI-13]; Committees: House – Judiciary

 

H.R.4363 – 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: Wasserman Schultz, Debbie [Rep.-D-FL-25]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.Res.561 – 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: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4368 – Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Harris, Andy [Rep.-R- MD-1]; Committees: House – Appropriations

 

H.R.4371 – To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, and in consultation with the Secretary of Education and the President’s Council on Fitness, Sports, and Nutrition, to conduct a study on the causes of deaths and catastrophic injuries related to high school and collegiate sports and formulate recommendations to prevent such deaths and catastrophic injuries, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.4375 – To amend title XVIII of the Social Security Act to provide coverage of medically necessary home resiliency services under Medicare; Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4381 – To amend the Public Health Service Act with respect to the determination, termination, and renewal of public health emergencies, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Rules

 

H.R.4382 – To require the Secretary of Agriculture to conduct a study on the accessibility of addiction and mental health care providers and services for farmers and ranchers who have been impacted by severe and persistent drought, extreme weather events, instability in the commodities market, misinformation targeting consumers, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Agriculture

 

H.R.4383 – 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: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

 

H.R.4391 – To amend the Internal Revenue Code of 1986 to treat certain assisted reproduction expenses as medical expenses of the taxpayer; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Ways and Means

 

H.R.4392 – To increase access to pre-exposure prophylaxis to reduce the transmission of HIV; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Oversight and Accountability; Ways and Means; Veterans’ Affairs; Armed Services; Natural Resources; Financial Services; Education and the Workforce