Congress is fast approaching the end of the fiscal year on September 30th without a clear path to avoid a federal government shutdown. Republicans in the House of Representatives are struggling to agree upon a set of demands for cutting government spending. House Speaker Kevin McCarthy (R-Calif.) abandoned plans for a Saturday vote on a temporary funding measure that was intended to appease a small group of conservative members. The decision followed McCarthy’s third failed attempt to bring the latest defense spending bill to the floor. The chamber is instead expected to vote this week on four fiscal year 2024 (FY24) appropriations bills – including the Agriculture-Rural Development-Food and Drug Administration funding bill – which include provisions to address specific conservative priorities. The approach is an attempt to unify members behind a separate stopgap spending bill which would include immediate spending cuts while government funding negotiations for FY24 are ongoing. Democrats continue to urge McCarthy to support a bipartisan deal, an idea that already has the support of some moderate House Republicans. McCarthy, however, will risk a motion to vacate the chair from conservative members seeking to oust him as speaker should he pursue a bipartisan approach. While the House typically takes the lead in moving government funding bills, the Senate began the process of considering a potential legislative vehicle for a continuing resolution (CR) last week. A vote is expected on the measure this week. There is bipartisan support in the upper chamber for a CR that keeps funding at current levels to provide time for leadership to continue negotiating a bicameral deal for the next fiscal year.

 

House Appropriations Panel May Soon Complete FY24 Markups

The House Appropriations Committee is reportedly planning to consider their final two FY24 spending bills – Commerce-Justice-Science and Labor-Health and Human Services-Education – in the coming days. The markups are in response to demands from conservative Republicans pushing for more votes on spending cuts before the end of the fiscal year. Conservatives aim to cut discretionary spending to $1.526 trillion – lower than the previously agreed upon $1.59 trillion in this year’s debt ceiling agreement – but it remains unclear from where the additional $64 billion in cuts will be drawn.

 

House Republicans Release Budget Resolution

Republicans in the House of Representatives released a budget resolution last week dubbed “Reverse the Curse” which would balance the budget within a decade and make reforms to federal health programs. The budget includes $16 trillion in deficit cuts and calls for the creation of a bipartisan commission to address the major drivers of the federal deficit. The document would add per-capita limits to federal funding for Medicaid and stricter work requirements for Medicaid, and proposes site-neutral payments in the Medicare program. The nation’s gross national debt exceeded the $33 trillion mark for the first time ever earlier this month.

 

HELP Advances Primary Care, Health Care Workforce Bill

The Senate Health, Education, Labor and Pensions (HELP) Committee advanced its bipartisan primary care and health care workforce package (S. 2840) in a 14-7 vote last week. Sen. Roger Marshall (R-Kan.), who co-authored the bill with Chairman Bernie Sanders (I-Vt.), alongside Sens. Mike Braun (R-Ind.) and Lisa Murkowski (R-Alaska), joined panel Democrats in support of the measure. The Bipartisan Primary Care and Health Workforce Act includes an almost $2 billion annual increase in mandatory funding for community health centers – totaling $5.8 billion annually for three years. The bill would triple mandatory funding for the National Health Service Corps, from $310 million to $950 million annually for three years, while also providing $1.5 in mandatory funding over the next five years to the Teaching Health Centers Graduate Medical Education program. Ranking Member Bill Cassidy (R-La.) filed 67 amendments to the bill detailing his concerns with the legislation. During the markup Cassidy highlighted that the legislation includes $26 billion in mandatory spending but only includes approximately $10 billion in offsets. Sanders has stated that he is working with leadership of the Judiciary and Finance committees on additional offsets for the bill. The Judiciary and Finance panels have each advanced their own health care proposals this year, including measures to overhaul the pharmacy benefit manager industry and to reform the nation’s patent system, which could eventually be packaged together with HELP’s workforce bill.

 

Health Transparency Legislation Pulled from House Floor

House leadership unexpectedly canceled plans to consider the bipartisan Lower Costs, More Transparency Act (H.R. 5378) under suspension of the rules last week. The bill includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Centers Graduate Medical Education Program. While it remains unclear why the bill was pulled from the House schedule, Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) stated that she remains “100% committed to getting this bill up for consideration on the floor, passed out of the House, and ultimately onto the president’s desk.”

 

Markey, Manchin Comment on FDA Evaluation of Opioid Risks

Sens. Ed Markey (D-Mass.) and Joe Manchin (D-W.Va.) have sent a letter to the Commissioner of Food and Drugs Robert Califf expressing concerns about how his agency evaluates opioids for chronic pain. They urge the Food and Drug Administration to reconsider the use of enriched enrollment randomized withdrawal (EERW) research methods to determine the efficacy and tolerability of extended-release and long-acting opioids in chronic pain patients. The letter warns that the use of EERW risks biasing findings in favor of opioid use and exposing clinical trial participants to opioid dependence and withdrawal.

 

VA Democrat Wexton Will Not Seek Re-Election

Rep. Jennifer Wexton (D-Va.) announced that she will not run for reelection next year. The three-term congresswoman cited her recent diagnosis with the rare neurological disorder progressive supranuclear palsy as the reason for her decision. Wexton currently serves on the House Appropriations and Budget committees.

 

CFPB to Propose Keeping Medical Debt Off Credit Reports

The Biden administration plans to propose that medical debt be barred from impacting individual’s credit scores. Under the planned rule, from the Consumer Financial Protection Bureau (CFPB), credit reporting companies would not be permitted to include medical debts in consumer reports and would be prohibited from using coercive collection practices more generally. The agency is also seeking to ban lenders from using medical collections information when considering a borrower’s application. The changes are a part of the agency’s effort to update the 1970 Fair Credit Reporting Act. CFPB plans to issue the proposed rulemaking in 2024.

 

UTSA to Offer First Dual Degree in Medicine and AI

The University of Texas Health Science Center at San Antonio will offer the first combined Doctor of Medicine and Master of Science in artificial intelligence degree in the nation. The five-year program includes three tracks in the master’s portion of the dual degree: data analytics, computer science, and intelligent and autonomous systems. Prospective dual degree students must first complete one year at the Long School of Medicine at UT Health San Antonio.

 

Upcoming Congressional Hearings and Markups

Senate Banking, Housing, and Urban Affairs Committee executive session to consider S. 2860, the SAFER Banking Act; 9:30 a.m.; September 27

 

Senate Budget Committee hearing “Medicare Forever: Protecting Seniors by Making the Wealthy Pay Their Fair Share;” 10:00 a.m.; September 27

 

House Education and the Workforce Subcommittee on Workforce Protections hearing “Examining the Policies and Priorities of the Occupational Safety and Health Administration;” 10:15 a.m.; September 27

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.Res.692 – Expressing support for the designation of September 2023 as “Sickle Cell Disease Awareness Month” in order to educate communities across the United States about sickle cell disease and the need for research, early detection methods, effective treatments, and preventative care programs with respect to complications from sickle cell disease and conditions related to sickle cell disease; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Energy and Commerce

 

H.Res.693 – Expressing support for the designation of September 9 as “National African Immigrant and Refugee HIV/ AIDS and Hepatitis Awareness (NAIRHHA) Day”; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]; Committees: House – Energy and Commerce

 

H.R.5526 – To amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5539 – To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program; Sponsor: Joyce, John [Rep.-R-PA-13]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5541 – To provide temporary licensing reciprocity for telehealth and interstate health care treatment; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Energy and Commerce

 

H.R.5545 – To authorize an Action Plan for United States foreign assistance to developing countries to increase access to sustainable safe water, sanitation, and hygiene in healthcare facilities, promote stronger health systems and sustainable health infrastructure, build capacity of health workers, and promote the safety of health workers and patients, especially women and girls, and for other purposes; Sponsor: Meng, Grace [Rep.-D-NY-6]; Committees: House – Foreign Affairs

 

H.R.5547 – To amend title XI of the Social Security Act to protect access to genetically targeted technologies; Sponsor: Nickel, Wiley [Rep.-D-NC-13]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.349 – A resolution supporting the designation of September 19, 2023, as “National Stillbirth Prevention Day”, recognizing tens of thousands of American families that have endured a stillbirth, and seizing the opportunity to keep other families from experiencing the same tragedy; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.352 – A resolution designating September 2023 as “National Childhood Cancer Awareness Month”; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Latest Action: Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2837 – A bill to amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.2840 – A bill to improve access to and the quality of primary health care, expand the health workforce, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2846 – A bill to improve Federal efforts with respect to the prevention of maternal mortality, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Finance

 

S.2850 – A bill to extend protections to part-time workers in the areas of family and medical leave and to ensure equitable treatment in the workplace; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2853 – A bill to require the Secretary of Health and Human Services and the Secretary of Labor to conduct a study and issue a report on grant programs to support the nursing workforce; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.700 – Expressing support for the designation of September 2023 as “National Prostate Cancer Awareness Month”; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce

 

H.R.5555 – To direct the Secretary of Health and Human Services to provide for certain adjustments to Medicare payment for items of durable medical equipment that were formerly included in round 2021 of the DMEPOS competitive bidding program; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5561 – To prohibit the President and the Secretary of Health and Human Services from declaring certain emergencies or disasters for the purpose of imposing gun control; Sponsor: Cloud, Michael [Rep.-R-TX-27]; Committees: House – Transportation and Infrastructure; Energy and Commerce

 

H.R.5568 – To improve Federal efforts with respect to the prevention of maternal mortality, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.5575 – To direct the Secretaries of Health and Human Services, Defense, and Veterans Affairs to end American over-dependence on Chinese pharmaceuticals by encouraging the growth of a robust domestic medicine supply chain for generic drugs, to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination, and for other purposes; Sponsor: Posey, Bill [Rep.-R-FL-8]; Committees: House – Energy and Commerce; Armed Services; Veterans’ Affairs; Ways and Means

 

H.R.5578 – To extend protections to part-time workers in the areas of family and medical leave and to ensure equitable treatment in the workplace; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability; Judiciary

 

S.2860 – A bill to create protections for financial institutions that provide financial services to State-sanctioned marijuana businesses and service providers for such businesses, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Banking, Housing, and Urban Affairs

 

H.Res.708 – Supporting the designation of the week of September 18 through September 23, 2023, as “Malnutrition Awareness Week”; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce; Agriculture; Education and the Workforce; Ways and Means

 

H.Res.709 – Supporting the designation of September 2023, as “National Cholesterol Education Month”, and September 30, 2023, as LDL-C Awareness Day; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Energy and Commerce

 

H.R.5584 – To amend title XIX of the Social Security Act to provide clarification with respect to the liability of third party payers for medical assistance paid under the Medicaid program, and for other purposes; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce

 

H.R.5592 – To prohibit the use of Federal funds from preventing a State from implementing their own laws with respect to psilocybin; Sponsor: Garcia, Robert [Rep.-D-CA-42]; Committees: House – Energy and Commerce; Judiciary

 

H.R.5598 – To amend the SUPPORT for Patients and Communities Act to reauthorize a youth prevention and recovery initiative; Sponsor: Lee, Susie [Rep.-D-NV-3]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.5601 – To decriminalize and deschedule cannabis, to provide for reinvestment in certain persons adversely impacted by the War on Drugs, to provide for expungement of certain cannabis offenses, and for other purposes; Sponsor: Nadler, Jerrold [Rep.-D-NY-12]; Committees: House – Judiciary; Energy and Commerce; Agriculture; Education and the Workforce; Ways and Means; Small Business; Natural Resources; Oversight and Accountability; Transportation and Infrastructure

 

H.R.5607 – To amend the Internal Revenue Code of 1986 to allow both spouses to make catch-up contribution to the same health savings account; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Ways and Means

 

H.R.5608 – To allow individuals to elect to receive contributions to a health savings account in lieu of reduced cost- sharing under health insurance obtained through a health insurance Exchange; Sponsor: Steube, W. Gregory [Rep.-R- FL-17]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5609 – To prohibit the use of Federal funds for security protection for the former Director of the National Institute of Allergy and Infectious Diseases who served between January 1984 and December 2022; Sponsor: Strong, Dale W. [Rep.-R- AL-5]; Committees: House – Judiciary

 

H.R.5611 – To amend title XVIII of the Social Security Act to provide for permanent payments for telehealth services furnished by Federally qualified health centers and rural health clinics under the Medicare program; Sponsor: Thompson, Glenn [Rep.-R-PA-15]; Committees: House – Energy and Commerce; Ways and Means

 

S.2880 – A bill to amend title XVIII of the Social Security Act to expand the scope of practitioners eligible for payment for telehealth services under the Medicare program, and for other purposes; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Finance

 

S.2886 – A bill to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so; Sponsor: Van Hollen, Chris [Sen.-D- MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2891 – A bill to reauthorize the program of grants for innovative programs to address dental workforce needs; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2897 – A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2907 – A bill to improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D- IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2909 – A bill to provide for congressional review of rules rescheduling marijuana; Sponsor: Lummis, Cynthia M. [Sen.- R-WY]; Committees: Senate – Judiciary

 

S.2911 – A bill to prohibit the President and the Secretary of Health and Human Services from declaring certain emergencies or disasters for the purpose of imposing gun control; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Homeland Security and Governmental Affairs

 

H.Res.722 – Supporting the designation of the week of September 18 through September 22, 2023, as “National Community Health Worker Awareness Week”; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

 

H.Con.Res.67 – Supporting the designation of the week of September 17 through September 23, 2023, as “National Fall Prevention Awareness Week” to raise awareness about, and encourage the prevention of, falls among older adults; Sponsor: Frankel, Lois [Rep.-D-FL-22]; Committees: House – Energy and Commerce

 

H.R.5615 – To amend the Comprehensive Addiction and Recovery Act of 2016 to authorize the Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, to award grants to covered entities to establish or maintain disposal sites for unwanted prescription medications, and for other purposes; Sponsor: Bonamici, Suzanne [Rep.- D-OR-1]; Committees: House – Energy and Commerce

 

H.R.5623 – To amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide substance use and alcohol use disorder services, and for other purposes; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Transportation and Infrastructure

 

H.R.5633 – To direct the Secretary of Veterans Affairs to conduct a review of the deaths of certain veterans who died by suicide, and for other purposes; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Veterans’ Affairs

 

H.R.5636 – To amend chapter 110 of title 18, United States Code, to prohibit gender affirming care on minors; Sponsor: Greene, Marjorie Taylor [Rep.-R-GA-14]; Committees: House – Judiciary

 

H.R.5647 – To amend title XXVII of the Public Health Service Act to require out-of-network coverage for qualified individuals diagnosed with a rare pediatric disease participating in approved clinical trials, and for other purposes; Sponsor: McCaul, Michael T. [Rep.-R-TX-10]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5652 – To amend the 21st Century Cures Act to require funds to be set aside for opioid reversal agent administration training in schools, and for other purposes; Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House – Energy and Commerce

 

H.R.5662 – To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.- D-IL-9]; Committees: House – Energy and Commerce

 

H.R.5663 – To amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce; Ways and Means

CSenate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and panel member Roger Marshall (R-Kan.) have reached an agreement on a health care workforce package that would provide a significant funding increase for the nation’s community health centers. The Bipartisan Primary Care and Health Workforce Act includes an almost $2 billion annual increase in mandatory funding for community health centers – totaling $5.8 billion annually for three years. The bill would triple mandatory funding for the National Health Service Corps, from $310 million to $950 million annually for three years, while also providing $1.5 in mandatory funding over the next five years to the Teaching Health Centers Graduate Medical Education program. The package provides $1.2 billion in mandatory funding for two-year registered nursing program grants and authorizes or reauthorizes discretionary funding for other nursing workforce programs. The bill would ban hospitals from certain anti-competitive contracting clauses in negotiations with commercial insurance companies, and would restrict hospitals from charging facility fees for services that do not occur on a hospital campus. The legislation does not have the support of HELP Committee Ranking Member Bill Cassidy (R-La.), who argues that the bill “lacks full Hyde [Amendment] protections and drastically increases spending without a plan to pay for it.” Cassidy has expressed support for the package being advanced in the House of Representatives which contains lower funding amounts. Chairman Sanders has said that he is still working to improve the spending offsets contained in the agreement. Sen. Marshall stated that the bill would be “fully paid for by combatting the enormous waste, fraud, and abuse in the health care system, making it easier for patients to access low-cost generic drugs, and holding pharmacy benefit managers (PBMs) accountable, among other provisions,” while his staff has specified to reporters that the deal would be partly paid for with PBM reforms advanced by the HELP and Finance committees earlier this year. The Bipartisan Primary Care and Health Workforce Act is scheduled to be marked up by the HELP Committee on Thursday. It likely can be passed out of Committee without any additional Republican votes, but it will require further bipartisan support to pass on the Senate floor. Funding for community health centers and authorization for other programs expires at the end of the month.

 

Transparency Bill Expected to Advance in the House

The House is set to vote this week on the Lower Costs, More Transparency Act (H.R. 5378). The package is focused on increasing transparency in the hospital, insurer, and PBM industries. It includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Center Graduate Medical Education Program. The legislation is backed by both Chair Cathy McMorris Rodgers (R-Wash.) and Ranking Member Frank Pallone (D-N.J.) of the Energy and Commerce Committee, Ways and Means Committee Chairman Jason Smith (R-Mo.), and Education and the Workforce Chair Virginia Foxx (R-N.C.). However, the top Democrats on the Ways and Means and Education and the Workforce panels did not join in introducing the bill.

 

Update on Government Funding Negotiations

The Senate voted to expedite debate on a fiscal year (FY) 2024 funding bill (H.R. 4366) for the departments of Veterans Affairs, Agriculture, Transportation, and Housing and Urban Development last week. Thirty-seven Republicans joined Senate Democrats in backing the measure, which contains $100 billion more in spending than supported by Republicans in the House of Representatives. It also lacks several border security and anti-abortion provisions being sought by GOP members of the House. After passing the three-bill spending package, the Senate then plans to vote on a stopgap spending bill containing $24 billion in aid to Ukraine and $16 billion in disaster funding.

 

Republicans in the House announced on Sunday that they had reached a deal on a continuing resolution (CR) to fund the federal government through October 31. The CR would trigger a 1% cut to current spending levels. The cut would not be applied equally across the budget; the Department of Defense and Veterans Affairs would not see any spending reductions, while the rest of the government would see an immediate 8% cut until the end of October. The proposal was negotiated by Main Street Caucus members Dusty Johnson (R-S.D.), Stephanie Bice (R-Okla.) and Kelly Armstrong (R-N.D.) and Freedom Caucus members Scott Perry (R-Pa.), Chip Roy (R-Tex.) and Byron Donalds (R-Fla.). If the House passes the CR deal, the Senate will need to respond by either passing the package or sending an amended version back to the House. The latter is more likely given the House agreement is not bipartisan and unlikely to be signed into law by the White House.

 

HELP Chair Sanders Agrees to Confirmation Hearing for NIH Nominee

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) has committed to holding a confirmation hearing next month on the nomination of Dr. Monica Bertagnolli to serve as Director of the National Institutes of Health. Sanders’ statement followed an announcement by the Biden administration that it had secured an agreement from biotech company Regeneron to limit the list price of a next-generation monoclonal antibody treatment for COVID-19 to equal to or less than the price in other major countries. Chairman Sanders had previously pledged to oppose all administration health nominees until the White House took unilateral action to cut drug prices.

 

Senators Ask DEA to Extend Virtual Prescribing Flexibilities

Abipartisan group of senators have written to the Drug Enforcement Administration (DEA) urging the agency to maintain access to care in its telemedicine prescribing policies. The lawmakers ask DEA to extend COVID-era flexibilities permitting the virtual prescribing of controlled substances for new patients beyond November 2023, and to extend the 30-day supply allowed for the prescription of controlled substances before a patient must see their doctor in person. The letter expresses concerns about the ability of patients to obtain in-person appointments within 30 days of starting a new medication, and “the potential consequences to their health of starting a new medication and abruptly ending it should they not be able to obtain such an appointment.” The lawmakers also recommend that DEA establish a special registration process to enable providers to prescribe controlled substances without an in-person visit. The letter was signed by Sens. Mark Warner (D-Va.), John Thune (R-S.D.), Catherine Cortez Masto (D-Nev.), Shelley Moore Capito (R-W. Va.), Sheldon Whitehouse (D-R.I.), and Dan Sullivan (R-Alaska).

 

Romney Announces Decision to Not Seek Reelection

Sen. Mitt Romney (R-Utah) announced that he will not seek a second term in the U.S. Senate last week. Romney cited his age, 76, as the reason for his decision, calling for support for a new generation of leaders “to make the decisions that will shape the world they will be living in.” Romney currently serves on the Foreign Relations Committee, Health, Education, Labor and Pensions Committee, the Homeland Security and Governmental Affairs Committee, and the Budget Committee. Romney told reporters that he does not plan to endorse anyone to replace him next year.

 

Challenges to the No Surprises Act Continue

The Texas Medical Association and other medical providers filed a brief last week in the U.S. Court of Appeals for the Fifth Circuit arguing that federal agencies rewrote the law to favor health insurers in their implementation of the No Surprises Act (NSA). “What insurers could not obtain through the legislative process, the federal Departments implementing the NSA have given them through rulemaking,” the plaintiffs state. The providers express opposition to the administration’s decision to direct independent dispute resolution entities to give primary consideration to the qualifying payment amount (QPA) as they work to settle billing disputes, and challenge the underlying method laid out to calculate the QPA.

 

POLICY BRIEFINGS

 

Latest COVID-19 Boosters Now Available

The latest COVID-19 boosters are now available in the U.S. following sign-off by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). CDC Director Mandy Cohen formally endorsed the updated mRNA shots from Pfizer Inc. and Moderna Inc. on Tuesday after the Advisory Committee on Immunization Practices voted 13-1 to recommend its use in those aged six months and older. The vaccines were approved by the FDA for those aged 12 and older, and authorized under emergency use for those aged six months and older. The shots are formulated to prevent severe disease and hospitalization from the XBB1.5 strain and other XBB subvariants of the virus, which represent 90% of subvariants currently circulating as of this month. The companies have said that the vaccines will cost between $110 and $130. Private insurers, Medicare, and Medicaid will cover the shot at no cost to patients. Children who are uninsured will be able to access the vaccine through the federal Vaccines For Children program, and the administration plans to distribute the vaccine through its Bridge Access Program for other uninsured Americans.

 

Upcoming Congressional Hearings and Markups

House Ways and Means Committee hearing “Reduced Care for Patients: Fallout from Flawed Implementation of Surprise Medical Billing Protections;” 10:00 a.m.; September 19

 

House Energy and Commerce Subcommittee on Health legislative hearing “Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology;” 10:00 a.m.; September 19

 

House Oversight and Accountability Committee hearing “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered;” 10:00 a.m.; September 19 Senate Finance Subcommittee on Health Care hearing “Aging in Place: The Vital Role of Home Health in Access to Care;” 10:00 a.m.; September 19

 

House Veterans’ Affairs Subcommittee on Health hearing “VA’s Federal Supremacy Initiative: Putting Veterans First?” 10:15 a.m.; September 19

 

House Energy and Commerce Committee Member Day hearing; 2:00 p.m.; September 19

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce legislative hearing “Mapping America’s Supply Chains: Solutions to Unleash Innovation, Boost Economic Resilience, and Beat China;” 10:30 a.m.; September 20

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “At What Cost: Oversight of How the IRA’s Price Setting Scheme Means Fewer Cures for Patients;” 2:00 p.m.; September 20

 

House Ways and Means Subcommittee on Trade hearing “Reforming the Generalized System of Preferences to Safeguard U.S. Supply Chains and Combat China;” 2:00 p.m.; September 20

 

House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet hearing “IP and Strategic Competition with China: Part III – IP Theft, Cybersecurity, and AI;” 3:00 p.m.; September 20

 

Senate Committee on Veterans’ Affairs hearing to examine improving mental health and suicide prevention measures for our Nation’s veterans; 3:30 p.m.; September 20

 

House Energy and Commerce Subcommittee on Communications & Technology hearing “Connecting Every American: The Future of Rural Broadband Funding;” 9:00 a.m.; September 21

 

Senate Health, Education, Labor, and Pensions Committee executive session to consider S. 1573, PREEMIE Reauthorization Act of 2023; S. 2415, Preventing Maternal Deaths Reauthorization Act of 2023; S. 1624, Gabriella Miller Kids First Research Act 2.0; and S._, Bipartisan Primary Care and Health Workforce Act; 10:00 a.m.; September 21

 

Recently Introduced Health Legislation

H.R. 5360 – A bill to amend the Medicare Improvements for Patients and Providers Act of 2008 to extend funding outreach and assistance for low-income programs; Sponsor: Craig, Angie [D-MN-02]; Committees: House Ways and Means, Energy and Commerce

 

H.R. 5368 – A bill to prohibit through December 31, 2024, the imposition of a mask mandate on passengers of air carriers or public transit and in educational settings within the United States, and for other purposes; Sponsor: Greene, Marjorie [R-GA-14]; Committees: Energy and Commerce, Transportation and Infrastructure, and Education and the Workforce

 

H.R. 5371 – A bill to amend title XVIII of the Social Security Act to clarify payment rules for manual wheelchairs under part B of the Medicare program; Sponsor: Joyce, David [R-PA-13]; Committees: Energy and Commerce, Ways and Means

 

H.R. 5372 – A bill to amend Title XVIII of the Social Security Act to facilitate midyear formulary changes for biosimilars; Sponsor: Joyce, David [R-PA-13]; Committees: Energy and Commerce, Ways and Means

 

H.R. 5376 – 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: Miller-Meeks, Mariannette [R-IA-01]; Committees: Energy and Commerce, Ways and Means

 

H.R. 5378 – A bill to promote price transparency in the health care sector, and for other purposes; Sponsor: Rodgers, Cathy McMorris [R-WA-05]; Committees: Energy and Commerce, Ways and Means, and Education and the Workforce

 

H.R. 5379 – A bill to require the Secretary of Health and Human Services to publish all information in the possession of the Department of Health and Human Services relating to the origin of COVID-19, and for other purposes; Sponsor: Roy, Chip [R-TX-21]; Committee: Energy and Commerce

 

H.R. 5380 – A bill to amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage; Sponsor: Sarbanes, John [D-MD-03]; Committees: Ways and Means, Energy and Commerce

 

H. Res. 672. A resolution calling for sickle cell trait research, surveillance, and public education and awareness, and for other purposes; Sponsor: Lee, Barbara [D-CA-12]; Committee: Energy and Commerce

 

S.2754 – A bill to require the Secretary of Health and Human Services to publish all information in the possession of the Department of Health and Human Services relating to the origin of COVID-19, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2764 – A bill to amend title XVIII of the Social Security Act to provide for a rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

S.2766 – A bill to amend title V of the Public Health Service Act; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2768 – A bill to protect hospital personnel from violence, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D- WV]; Committees: Senate – Judiciary

 

S.2771 – A bill to allow additional individuals to enroll in standalone dental plans offered through Federal Exchanges; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.676 – Supporting the designation of the week of September 17 through September 23, 2023, as “Telehealth Awareness Week”; Sponsor: Johnson, Bill [Rep.-R-OH-6]; Committees: House – Energy and Commerce

 

H.Res.678 – Recognizing the seriousness of polycystic ovary syndrome (PCOS) and expressing support for the designation of the month of September 2023 as “PCOS Awareness Month”; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House – Energy and Commerce

 

H.R.5384 – To amend title XVIII of the Social Security Act to provide for the automatic qualification of certain Medicaid beneficiaries for premium and cost-sharing subsidies under part D of the Medicare program, and for other purposes; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5385 – 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: Landsman, Greg [Rep.-D- OH-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5386 – To amend title XVIII of the Social Security Act to provide for adjustments to the Medicare part D cost-sharing reductions for low-income individuals; Sponsor: McGarvey, Morgan [Rep.-D-KY-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5387 – To improve the provision of health care to unsheltered homeless individuals, and for other purposes; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Energy and Commerce; Education and the Workforce; Financial Services

 

H.R.5388 – To amend title XVIII of the Social Security Act to provide coverage of certain technologies and medical devices under the Medicare program; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5389 – To amend title XVIII of the Social Security Act to ensure transparency in the national coverage determination process under the Medicare program; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5390 – To direct the Secretary of Commerce to conduct a study on the feasibility of manufacturing in the United States products for critical infrastructure sectors, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R- IA-1]; Committees: House – Energy and Commerce

 

H.R.5391 – To amend title XVIII of the Social Security Act to provide for a rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5392 – To amend title XVIII of the Social Security Act to ensure timely review of local coverage determination requests under the Medicare program; Sponsor: Dunn, Neal P. [Rep.-R-FL-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5393 – To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5394 – To ensure appropriate access to remote monitoring services furnished under the Medicare program; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5395 – To amend title XVIII of the Social Security Act to establish a demonstration program relating to medical necessity determinations under the Medicare program; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5396 – To amend title XVIII of the Social Security Act to prohibit Medicare local coverage determinations from restricting access to care, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5397 – To amend title XVIII of the Social Security Act to provide coverage of external infusion pumps and non- self-administrable home infusion drugs under the Medicare program; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5399 – To substantially restrict the use of animal testing for cosmetics, and for other purposes; Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Energy and Commerce

 

H.R.5400 – To amend title XVIII of the Social Security Act to assure pharmacy access and choice for Medicare beneficiaries; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5405 – To ensure that a fair percentage of Federal cancer research funds are dedicated to pediatric cancer research; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

 

H.R.5406 – To require the Secretary of Health and Human Services to establish a clearinghouse of zip-code based information to expecting mothers, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.5414 – To authorize the Secretary of Health and Human Services, acting through the Director of the Center for Mental Health Services of the Substance Abuse and Mental Health Services Administration, to award grants to implement innovative approaches to securing prompt access to appropriate follow-on care for individuals who experience an acute mental health episode and present for care in an emergency department, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

 

H.R.5416 – To amend title 38, United States Code, to provide for the automatic enrollment of eligible veterans in patient enrollment system of Department of Veterans Affairs, and for other purposes; Sponsor: Takano, Mark [Rep.-D-CA-39]; Committees: House – Veterans’ Affairs

 

H.R.5418 – To amend title V of the Public Health Service Act; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.5420 – To require the Secretary of Labor to issue guidance and regulations regarding opioid overdose reversal medication and employee training; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Education and the Workforce

 

S.Res.340 – A resolution supporting the designation of September 13, 2023, as National Sepsis Day; Sponsor: Schumer, Charles E. [Sen.-D-NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2780 – A bill to require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2782 – A bill to provide the Food and Drug Administration with authority to conduct microbial sampling on concentrated animal feeding operations as necessary to facilitate a foodborne illness outbreak investigation, determine the root cause of an outbreak of foodborne illness, or address other public health needs; Sponsor: Booker, Cory A. [Sen.-D- NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2797 – A bill to ensure religious freedom and rights of conscience for health care workers and other government employees, and to protect health care workers and other government employees from various forms of compelled speech; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Judiciary

 

H.R.5429 – To require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the Food and Drug Administration and the United States Patent and Trademark Office; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Judiciary

 

H.R.5434 – To amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children’s Health Insurance Program; Sponsor: Dingell, Debbie [Rep.-D- MI-6]; Committees: House – Energy and Commerce

 

H.R.5452 – To amend title V of the Public Health Service Act; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

S.Res.343 – A resolution supporting the designation of September 17, 2023, as “National Physician Suicide Awareness Day” to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.345 – A resolution supporting the designation of September 15, 2023, as “National Concussion Awareness Day”; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Latest Action: Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2799 – A bill to direct the Secretary of Health and Human Services to establish an Office of Rural Health, and for other purposes; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2801 – A bill to improve the reproductive assistance provided by the Department of Defense and the Department of Veterans Affairs to certain members of the Armed Forces, veterans, and their spouses or partners, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Veterans’ Affairs

 

S.2809 – A bill ensure references to opioid overdose reversal agents in certain grant programs of the Department of Health and Human Services are not limited to naloxone; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2815 – A bill to provide for a wage differential program to support new nursing school faculty members; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2816 – A bill to amend title XIX of the Social Security Act to make all children eligible for Medicaid from birth until age 19, to require States to automatically enroll children under age 19 in the State Medicaid program, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.2821 – 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 provide coverage for prostate cancer screenings without the imposition of cost-sharing requirements, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.686 – Supporting the designation of September 19, 2023, as “National Stillbirth Prevention Day”, recognizing tens of thousands of American families that have endured a stillbirth, and seizing the opportunity to keep other families from experiencing the same tragedy; Sponsor: Hinson, Ashley [Rep.-R-IA-2]; Committees: House – Energy and Commerce

 

H.Res.690 – Supporting the designation of September 17, 2023, as “National Physician Suicide Awareness Day” to raise awareness of, and promote a national discussion about, physician suicide and to reduce the stigma of mental health issues; Sponsor: Stevens, Haley M. [Rep.-D-MI-11]; Committees: House – Energy and Commerce

 

H.R.5458 – To direct the Patient Center Outcome Research Institute to prepare and release a report on home cardiorespiratory monitors for infants, and for other purposes; Sponsor: Yakym, Rudy [Rep.-R-IN-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5461 – To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5467 – To prohibit the sale of a firearm unless the firearm or packaging carries a label that provides the number of the National Suicide Prevention Lifeline; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Energy and Commerce

 

H.R.5470 – To extend temporary authority regarding license portability for certain practitioners to be able to practice across State borders, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Veterans’ Affairs

 

H.R.5481 – To direct the Secretary of Health and Human Services to establish an Office of Rural Health, and for other purposes; Sponsor: Guest, Michael [Rep.-R-MS-3]; Committees: House – Energy and Commerce

 

H.R.5492 – To improve the reproductive assistance provided by the Department of Defense and the Department of Veterans Affairs to certain members of the Armed Forces, veterans, and their spouses or partners, and for other purposes; Sponsor: Larsen, Rick [Rep.-D-WA-2]; Committees: House – Veterans’ Affairs; Armed Services

 

H.R.5506 – To amend titles XVIII and XIX of the Social Security Act and title 10, United States Code, to provide no-cost coverage for the preventive distribution of opioid overdose reversal drugs; Sponsor: Pettersen, Brittany [Rep.-D-CO-7]; Committees: House – Energy and Commerce; Ways and Means; Armed Services

 

H.R.5510 – To amend title XVIII of the Social Security Act to require coverage of 3 primary care visits without cost sharing each year under the Medicare program; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5514 – To authorize a pilot program to expand and intensify surveillance of self-harm in partnership with State and local public health departments, to establish a grant program to provide self-harm and suicide prevention services in hospital emergency departments, and for other purposes; Sponsor: Stewart, Chris [Rep.-R-UT-2]; Committees: House – Energy and Commerce

 

H.R.5518 – To amend title XVIII of the Social Security Act to require individuals the choice to opt in to enrollment in employer group waiver plans under Medicare Advantage; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5520 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Deputy Assistant Secretary for Minority Health, to award grants to faith- or community-based organizations to address persistent health inequities and chronic disease challenges; Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce

With the House of Representatives returning this week from a month-long summer recess, lawmakers must now work to pass legislation to fund the federal government by September 30 to avoid a shutdown at the end of the fiscal year (FY). Democrats are pushing for a stopgap spending measure that extends government funding through December 8 and includes $44 billion in emergency spending. While Senate Republicans appear open to a continuing resolution (CR), the conservative House Freedom Caucus has already expressed opposition to any clean CR that does not include the Secure the Border Act, address the “unprecedented weaponization of the Justice Department and FBI,” and “end the Left’s cancerous woke policies in the Pentagon.”

 

Should Congress fail to extend government funding, most essential health care services – including Medicare checks and the insurance exchanges – would not be disrupted. Under the U.S. Department of Health and Human Services (HHS) contingency plan, certain COVID-19 related activities like vaccine development and authorization and clinical trials would continue through the use of 2020 and 2021 emergency appropriations. The Centers for Disease Control and Prevention (CDC) has also pledged to maintain the Vaccines for Children Program and monitoring for public health threats in the case of a shutdown. Approximately 40% of the HHS workforce, however, would be furloughed. Medicare, Medicaid, and other mandatory health program staff would be retained.

 

Lawmakers must also act by September 30 to reauthorize the SUPPORT Act, the Pandemic and All-Hazards Preparedness Act (PAHPA), the Children’s Hospitals Graduate Medical Education Program, the President’s Emergency Plan for AIDS Relief (PEPFAR), and to extend funding for the Community Health Centers Fund. PAHPA reauthorization was placed on the Senate legislative calendar last week, but it remains unclear when the bill could come to the floor for a vote and how it could eventually be reconciled with the legislation being considered by the House of Representatives. The House is moving two separate bills – one to fund programs at the Administration for

 

Strategic Preparedness and Response, and one to fund programs at the CDC. Senate Foreign Relations Chairman Bob Menendez (D-N.J.) told reporters last week that he will push to extend PEPFAR for three years, rather than the usual five years, in response to pressure from Republicans to include anti-abortion language in the reauthorization. Although his initial goal was to pass a standalone reauthorization measure, Menendez is now aiming to attach the PEPFAR extension to a larger must-pass vehicle. The House Appropriations Committee included a one-year extension of PEPFAR along with the Mexico City Policy – prohibiting non-governmental organizations from performing or promoting abortion – in its FY 2024 State and Foreign Operations spending bill, but such a measure is opposed by the Biden administration and would be unlikely to pass the Democratically-controlled Senate.

 

Congress is expected to try and advance wide-ranging health care legislation before the end of the year as well. The House Energy and Commerce, Ways and Means, and Education and the Workforce committees introduced bipartisan legislation on Friday focused on increasing transparency in the hospital, insurer, and pharmaceutical benefit manager industries. The Lower Costs, More Transparency Act (H.R. 5378) includes many provisions previously advanced by the panels, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Center Graduate Medical Education Program. The package is expected to be considered on the House floor sometime this month. Senate Majority Leader Chuck Schumer (D-N.Y.) has also stated his intention to bring a health care package to the floor for a vote before the end of the year.

 

W&Ms Seeks Comments on Health Care Disparities

House Ways and Means Committee Chairman Jason Smith (R-Mo.) is requesting stakeholder input on how to address chronic disparities in access to health care in rural and underserved communities. As a part of the request for information, Smith highlights five key areas of interest:

• Payment disparities between different geographic areas;
• The long-term financial health of providers and facilities;
• Payments for identical care provided in varying sites of service;
• Bringing new professionals into the health care workforce; and
• Innovative care models and technology to improve patient outcomes.

Comments should be submitted to [email protected] no later than October 5, 2023.

 

Cassidy Releases AI White Paper, HIPAA RFI

Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-La.) released a framework for how to regulate artificial intelligence (AI) in health care last week. Cassidy’s white paper recommends a sector- specific approach to AI regulation in order to promote competition. He also suggests the use of targeted updates to medical device regulations to maintain safety while retaining flexibility for the industry. Comments on the framework will be accepted through September 22. Senate Majority Leader Chuck Schumer (D-N.Y.) is working to develop a comprehensive framework for AI regulation, but very little details have been provided as to what this effort will entail.

Cassidy also issued a request for information (RFI) seeking input “on ways to improve the privacy protections of health data to safeguard sensitive information while balancing the need to support medical research.” Responses will be used to help inform solutions to modernize the Health Insurance Portability and Accountability Act (HIPAA). Feedback should be submitted by September 28 to [email protected].

 

Finance Committee Continues Organ Donation System Investigation

Members of the Senate Finance Committee have expanded their bipartisan investigation into the nation’s organ donation system. Chairman Ron Wyden (D-Ore.) and Sens. Chuck Grassley (R-Iowa), Ben Cardin (D-Md.), and Todd Young (R-Ind.) sent letters of inquiry to eight organ procurement organizations (OPOs) last week requesting information dating back to 2015 about potential conflicts of interest and about the personal financial interests and business relationships of board members and executives. “OPOs and their executives have engaged in a complex web of financial relationships with tissue processors, researchers, testing laboratories, and logistics providers, which have the potential for creating conflicts of interest. Some OPOs have also engaged in criminal activity,” the letters assert.

 

CMS Announces New AHEAD Payment Model

The Centers for Medicare and Medicaid Services (CMS) announced a new voluntary payment model last week that would cap doctor and hospital payments in exchange for more flexibility to coordinate care. Under the States Advancing All-Payer Health Equity Approaches and Development Model (AHEAD), eight states, which have yet to be chosen, would agree to pay hospitals a global budget in lieu of fee-for-service Medicare and Medicaid payments. The states would be provided with an overall spending target based on projections of future spending. Primary care physicians who agree to participate would receive higher payments for meeting quality measures and addressing social determinants of health. States would receive $12 million to launch the new program, which CMS aims to start in January 2026 and run for 11 years. CMS hopes the model will encourage states to move care from hospitals to less costly settings.

 

FDA Releases Guidances to Modernize 510(k) Program

The Food and Drug Administration (FDA) released three draft guidances last week to support efforts to strengthen and modernize the 510(k) Program:

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
• Evidentiary Expectations for 510(k) Implant Devices

Comments on the draft guidances are due by December 6, 2023. According to the agency, the guidances are a part of the Center for Devices and Radiological Health’s work “to optimize the clarity, predictability, and consistency of the 510(k) Program as we implement the Medical Device User Fee Amendments 2022 (MDUFA V).” This work includes a new requirement that all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR starting October 1, 2023. The FDA will host a webinar for stakeholders interested in learning more about these draft guidances and the agency’s ongoing efforts to modernize the 510(k) Program on October 26, 2023.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

Senate Committee on Homeland Security and Governmental Affairs hearing “America’s Supply Chain Security: Understanding and Mitigating Threats;” 10:15 a.m.; September 12

 

Senate Commerce, Science, and Transportation Subcommittee on Consumer Protection, Product Safety, and Data Security hearing to examine the need for transparency in Artificial Intelligence; 2:30 p.m.; September 12

 

Senate Judiciary Subcommittee on Privacy, Technology, and the Law oversight hearing to examine A.I., focusing on legislating on artificial intelligence; 2:30 p.m.; September 12

 

House Appropriations Subcommittee on Military Construction, Veterans Affairs, and Related Agencies oversight hearing “Department of Veterans Affairs Implementation of the Electronic Health Record Modernization Initiative;” 9:30 a.m.; September 13

 

House Ways and Means Committee Member Day hearing; 9:00 a.m.; September 14

 

Senate Committee on Homeland Security and Governmental Affairs hearing “Governing AI Through Acquisition and Procurement;” 10:00 a.m.; September 14

 

House Energy and Commerce Subcommittee on Health legislative hearing “Legislative Proposals to Prevent and Respond to Generic Drug Shortages;” 10:00 a.m.; September 14

 

House Oversight and Accountability Subcommittee on the Coronavirus Pandemic hearing “Oh Doctor, Where Art Thou? Pandemic Erosion of the Doctor-Patient Relationship;” 10:00 a.m.; September 14

 

House Committee on Veterans’ Affairs hearing “VA Electronic Health Record Modernization: Get Well Soon?” 10:30 a.m.; September 14

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “The Inflation Reduction Act: A Year in Review;” 2:00 p.m.; September 14

 

Recently Introduced Health Legislation

H.R.5336 – To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services with respect to the determination of whether an individual is lawfully present in the United States for purposes of the eligibility of such individual for enrollment in certain health insurance programs. Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Energy and Commerce; Ways and Means

 

S.2718 – A bill to amend title 38, United States Code, to improve matters relating to medical examinations for veterans disability compensation, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.2719 – A bill to amend the Immigration and Nationality Act to provide for the reallocation of unused waivers of the foreign residency requirement for certain J-visa holders. Sponsor: Ernst, Joni [Sen.-R-IA]; Committees: Senate – Judiciary

 

S.2733 – A bill to address the behavioral health workforce shortages through support for peer support specialists, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2737 – A bill to require the Food and Drug Administration to determine whether to permit the use of enriched enrollment randomized withdrawal methodology with respect to clinical trials; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2745 – A bill to amend title 38, United States Code, to eliminate conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration and to limit the detail of directors of medical centers of Department of Veterans Affairs to different positions, and for other positions; Sponsor: Peters, Gary C. [Sen.-D- MI]; Committees: Senate – Veterans’ Affairs