HELP Committee Advances OAA Reauthorization-The Senate Health, Education, Labor, and Pensions (HELP)Committee voted 20-1 to reauthorize the Older Americans Act (OAA) last week. Sen. Rand Paul (R-Ky.) was the sole vote in opposition to the reauthorization. Under S. 4776, the Older Americans Act Reauthorization Act of 2024, OAA programs would receive an almost 5% increase in authorized funding through fiscal year 2029. The Committee also advanced the Autism Collaboration, Accountability, Research, Education, and Support (Autism CARES) Act of 2024 (S.4762) and the Traumatic Brain Injury Program Reauthorization Act (S.4755) on a bipartisan basis.
HSGAC Advances Healthcare Cybersecurity Act-The Senate Homeland Security and Governmental Affairs Committee (HSGAC) advanced the Healthcare Cybersecurity Act (S.4697) in a 10-1 vote last week with Sen. Rand Paul (R-Ky.) voting against the bill. This legislation directs the Cybersecurity and Infrastructure Security Agency (CISA) and the U.S. Department of Health and Human Services (HHS) to collaborate on improving cybersecurity and make resources available to non-federal entities relating to cyber threat indicators and appropriate defense measures. It would also create a special liaison to HHS within CISA to coordinate during cybersecurity incidents and collaborate to support health care and public health sector entities.
Senate Appropriators Advance FY25 LHHS Bill-The Senate Appropriations Committee approved its fiscal year (FY) 2025 Labor-Health and Human Services (LHHS) spending measure last week in a bipartisan 25-3 vote. Sens. Deb Fischer (R-Neb.), Marco Rubio (R-Fla.), and Bill Hagerty (R-Tenn.) voted in opposition the legislation and Sen. John Hoeven (R-N.D.) did not vote. The bill provides $122.8 billion in discretionary funding for HHS. The National Institutes of Health would receive $50.2 billion, an increase of $2.05 billion over current levels. The bill sustains $1.5 billion in funding for the Advanced Research Projects Agency for Health. The Centers for Disease Control and Prevention would see a funding increase of $173 million over FY24 levels. The bill includes $3.82 billion for the Administration for Strategic Preparedness and Response, an increase of $200 million over FY24. More information can be found in the bill summary, bill text, and report.
The Senate’s bill stands in stark contrast to the House of Representative’s FY25 LHHS spending bill, which would cut HHS funding by 7% and provide flat funding for the NIH while proposing structural reforms. The House had planned to bring their version of the bill to the floor for a vote, but instead adjourned early for August recess when it became clear the measure did not have enough support for passage. Lawmakers are expected to begin negotiations on a stopgap spending measure when both chambers return from recess in September.
Comer Requests CMS Briefing on OPO Guidance-House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the administration regarding its failure to issue guidance on the future of low performing organ procurement organizations (OPOs). The Centers for Medicare and Medicaid Services (CMS) finalized a rule in 2020 that would decertify the lowest performing-Tier 3-OPOs in 2026 based on their 2024 performance if they have failed to show improvement. CMS has yet to release guidance outlining how this decertification process would proceed or how higher performing OPOs should prepare to take over additional service areas. Approximately 42% of OPOs operated at the Tier 3 level in 2021, the most recent year with available data. “CMS’ inaction has created lack of clarity, increased uncertainty for Americans who need a transplant, and threatens to erode accountability for OPOs,” Comer writes. He requests a briefing from the agency that includes a description of the steps CMS is taking to ensure the final rule is implemented “without dilution or delay.”
Foxx Opposes Mental Health Parity Regulations-House Education and the Workforce Committee Chair Virginia Foxx (R-N.C.) sent a letter to the White House urging the administration to drop its proposed mental health parity rule. The rule is aimed at improving mental health coverage in commercial insurance plans by requiring parity between physical and mental health care in “non-quantitative treatment limitations” such as prior authorization. Foxx asserts that the rule lacks clarity and fails to consider workforce shortages amongst mental health professionals, arguing that it would actually decrease access to mental health treatment by disincentivizing employers from offering coverage. She also questions whether the rule exceeds agency authority in light of the Supreme Court’s overturning of the Chevron Deference.
Bucshon Remarks on VALID Act Status-Rep. Larry Bucshon, M.D. (R-Ind.) commented on the future of diagnostics reform legislation last week, appearing optimistic about the chances for bill passage in the next several years. The Food and Drug Administration (FDA) finalized a regulation earlier this year to provide greater oversight of laboratory developed tests (LDTs) within the agency’s existing medical device framework. Bucshon is the co-author of the bipartisan VALID Act (H.R.2369), which would create a new risk-based framework for the review of diagnostics and LDTs. Bucshon stated that many stakeholders’ opposition to the FDA rule has brought more parties back to the negotiating table on the VALID Act, and that the Supreme Court’s recent Chevron decision could result in litigation challenging the rule. Bucshon, who is retiring at the end of this year, has not yet secured a Republican to replace him alongside VALID Act co-lead Rep. Diana DeGette (D-Colo.).
Release of Senate 340B Bill Delayed-The release of legislation in the Senate to reform the 340B drug pricing program has been stalled, with the bill now not expected to be introduced until after the August recess. Sen. John Thune (R-S.D.) had previously expressed hopes that the bill would be rolled out last week, but its release was delayed by unspecified disagreements between Republican and Democratic members of the chamber’s bipartisan 340B working group. “It’s clear that we need a little more time to get this across the finish line,” GOP members of the working group-Sens. Thune, Jerry Moran (Kan.), and Shelley Moore Capito (W-Va.)-said in a statement.
CMS Releases FY25 IPPS Final Rule-Hospital payments will increase by $3.2 billion next year under the FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule released by CMS last week. The 2.9% increase will take effect October 1 and is in line with CMS’ initial proposed rule. The regulation also finalizes a separate IPPS payment for small, independent hospitals to establish and maintain a buffer stock of essential medicines. The agency asserts that such facilities are particularly vulnerable to supply disruptions, and that buffer stocks will help guard against future shortages. CMS’ fact sheet on the final rule can be found here.
Congressional Retirements and Resignations-Rep. Bob Good (R-Va.) was defeated by former Navy SEAL officer John McGuire in the Republican primary following a recount for Virginia’s 5th congressional district. Good was first elected to Congress in 2020 and serves on the Education and Workforce and Budget committees. He is currently the chairman of the House Freedom Caucus.
A running list of members of Congress who are retiring or seeking other office can be found below.
| SENATE | |
| Stabenow (D), MI | Braun (R), IN |
| Cardin (D), MD | Romney (R), UT |
| Carper (D), DE | |
| Butler (D), CA | |
| Manchin (D), WV | |
| Sinema (I), AZ | |
| Menendez (D), NJ (effective Aug. 20, 2024) | |
| HOUSE OF REPRESENTATIVES | |
| Porter (D), CA | Mooney (R), WV |
| Lee (D), CA | Banks (R), IN |
| Gallego (D), AZ | Bishop (R), NC |
| Schiff (D), CA | Lesko (R), AZ |
| Slotkin (D), MI | Granger (R), TX |
| Allred (D), TX | Burgess, MD (R), TX |
| Trone (D), MD | Wenstrup, DPM (R), OH |
| Blunt Rochester (D), DE | McHenry (R), NC |
| Napolitano (D), CA | Johnson (R), OH (effective Jan. 21, 2024) |
| Wexton (D), VA | Ferguson, IV, DMD, PC (R), GA |
| Kim, Andy (D), NJ | Curtis (R), UT |
| Jackson, Jeff (D), NC | Luetkemeyer (R), MO |
| Sarbanes (D), MD | Lamborn (R), CO |
| Blumenauer (D), OR | Bucshon, MD (R), IN |
| Kilmer (D), WA | Pence (R), IN |
| Spanberger (D), VA | Duncan (R), SC |
| Kildee (D), MI | Armstrong (R), ND |
| Phillips (D), MN | McMorris Rodgers (R), WA |
| Cardenas (D), CA | Gallagher (R), WI (effective April 19, 2024) |
| Eshoo (D), CA | LaTurner (R), KS |
| Manning (D), NC | Graves (R), LA |
| Nickel (D), NC | |
| Ruppersberger (D), MD | |
| Sablan (D), MP | |
| Kuster (D), NH | |
| Bowman (D), NY | |
Upcoming Congressional Hearings and Markups
Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?”10:00 a.m.; September 24
Recently Introduced Health Legislation
H.R.9179-To amend title 38, United States Code, to establish the Office of Falls Prevention of the Department of Veterans Affairs, and for other purposes; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House-Veterans’ Affairs; Education and the Workforce
S.4827-A bill to improve transparency and the availability of information regarding dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to list dietary supplements with the Food and Drug Administration; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions
S.4829-A bill to direct the Administrator of the Centers for Medicare & Medicaid Services to clarify that implanted active middle ear hearing devices are prosthetics and are not subject to the hearing aid coverage exclusion under the Medicare program; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Finance
S.Res.775-A resolution expressing support for the designation of July 15, 2024, as “National Leiomyosarcoma Awareness Day”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate-Health, Education, Labor, and Pensions
S.4831-A bill to amend the Older Americans Act of 1965 to include peer supports as a supportive service within the National Family Caregiver Support Program, to require States to consider the unique needs of caregivers whose families have been impacted by substance use disorder, including opioid use disorder, in providing services under such program, and for other programs; Sponsor: Budd, Ted [Sen.-R-NC]; Committees: Senate-Health, Education, Labor, and Pensions
S.4835-A bill to amend the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide for 3 primary care visits and 3 behavioral health care visits without application of any cost-sharing requirement; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate-Health, Education, Labor, and Pensions
S.4845-A bill to lower the cost of all drugs for all Americans; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions
S.4847-A bill to require the Secretary of Defense to conduct a study on active military-civilian partnerships at trauma centers of military medical treatment facilities within the Defense Health Agency; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Armed Services
S.4855-A bill to amend the Older Americans Act of 1965 to authorize the provision of appropriate training, resources, and best practices to the aging network under grants for projects that address negative health effects associated with social isolation among older individuals; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions
S.4860-A bill to amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance
S.4862-A bill to ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes; Sponsor: Rounds, Mike [Sen.-R-SD]; Committees: Senate-Health, Education, Labor, and Pensions
H.R.9184-To amend title XI of the Social Security Act to exclude from antikickback and other sanctions certain travel and lodging arrangements between manufacturers of drugs and individuals being administered such drugs, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House-Energy and Commerce; Ways and Means
H.R.9186-To amend title 10, United States Code, to ensure that medical records of the Department of Defense indicate the organizational affiliation of certain health care providers; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Armed Services
H.R.9194-To amend the Research and Development, Competition, and Innovation Act to support nucleic acid screening, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Science, Space, and Technology
H.R.9218-To establish a clear and consistent biological definition of male and female; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Judiciary
H.R.9232-To amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House-Ways and Means
H.R.9233-To amend the Public Health Service Act to require the Secretary of Health and Human Services to establish a program for the conduct and support of research, training, and health information dissemination with respect to environmental risk factors of neurodegenerative diseases, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House-Energy and Commerce
S.4878-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions
S.4879-A bill to prioritize funding for an expanded and sustained national investment in biomedical research; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Appropriations
S.4905-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: Reed, Jack [Sen.-D-RI]; Committees: Senate-Health, Education, Labor, and Pensions
S.4918-A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Health, Education, Labor, and Pensions
S.Res.794-A resolution designating September 25, 2024, as “National Ataxia Awareness Day”, and raising awareness of ataxia, ataxia research, and the search for a cure; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Judiciary
S.Res.799-A resolution supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2024; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.
S.4923-A bill to amend title IV of the Social Security Act to require States to provide information about available benefits and services to kinship caregivers; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance
S.4935-A bill to amend title XVIII of the Social Security Act to update the budget neutrality threshold under the Medicare physician fee schedule; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate-Finance
S.4937-A bill to require Senate approval before the United States assumes any obligation under a WHO pandemic agreement and to suspend funding for the WHO until such agreement is ratified by the Senate; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate-Foreign Relations
S.4942-A bill making appropriations for the Departments of Labor, Health and human Services, and Education, and related agencies for the fiscal year ending September 30, 2025, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate-Appropriations
S.4949-A bill to improve end-of-life care; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions
S.4957-A bill to amend the Public Health Service Act to provide for a health care workforce innovation program; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Health, Education, Labor, and Pensions
S.4964-A bill to provide for a comprehensive Federal response to Long COVID, including research, education, and support for affected individuals, to direct the National Institutes of Health to establish a Long COVID research program, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate-Health, Education, Labor, and Pensions
S.4968-A bill to improve the Institutional Development Award program of the National Institutes of Health; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Health, Education, Labor, and Pensions
S.4984-A bill to amend the Controlled Substances Act to require regulated persons to identify tableting machines and encapsulating machines by serial number; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary
S.4987-A bill to codify Chevron deference; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Homeland Security and Governmental Affairs