Congressional:

House Passes Health Care Bill, Conversations on ACA Tax Credits Continue Separately 

On Thursday, the House passed the Lower Health Care Premiums for All Americans Act (H.R.6703), in a 216-211 vote. The bill contains several Republican policy priorities, including expanding access to association health plans, codifying and improving individual coverage health reimbursement arrangements (ICHRAS), requiring transparency in contracts between plan sponsors and pharmacy benefit managers (PBMs), and appropriating cost-sharing reduction subsidies. The bill, however, did not include an extension of the enhanced premium tax credits (EPTCs). The Congressional Budget Office (CBO) and the staff of the Joint Committee on Taxation (JCT) estimated that enacting the bill would reduce the deficit by $35.6 billion over the 2026-2035 period. The CBO also estimated that enacting the bill would decrease the number of people with health insurance by an average of 100,000 over the 2027-2035 period and lower gross benchmark premiums by 11 percent, on average, through 2035.

On Wednesday, four moderate House Republicans signed on to Discharge Petition No. 10, offered by House Democratic Leader Hakeem Jeffries (D-NY), to advance a three-year extension of the EPTCs. With the four Republicans added, the discharge petition reached 218 signatures, meaning the House will have to vote on it the first week back in January.

In the Senate, a bipartisan group of nearly two dozen senators met on Monday, convened by Senators Susan Collins (R-ME) and Bernie Moreno (R-OH), to discuss an extension of the EPTCs, with a new income-eligibility cap and fraud-prevention language. Collins said Thursday that they are still working on the proposal, but there is not a definitive timeline for its release.

Senate Passes FDA Modernization Act 3.0

On Tuesday, the Senate passed the FDA Modernization Act 3.0 (S.355) by unanimous consent with a substitute amendment. The bill would require the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. 

Senate Rejects Joint Resolution Reversing HHS Exemption from Public Notice & Comment Requirements

On Thursday, the Senate failed to pass a joint resolution (S.J.Res.82) in a 50-50 vote. The resolution was introduced by Senator Angus King (I-ME) and would have repealed the Department of Health and Human Services (HHS) decision to waive public comment periods on some proposed changes to agency programs and policies. Earlier this year, HHS Secretary Robert Kennedy Jr. announced the agency would stop operating under a 1971 policy, known as the “Richardson Waiver,” which compelled the department to publish notices of proposed rulemaking in the Federal Register, hold public comment periods, and publish final rules for issues involving agency management, personnel, public property, loans, grants, benefits, and contracts. Senate Republicans Susan Collins (R-ME), Lisa Murkowski (R-AK), and Thom Tillis (R-NC) voted with Democrats.

Joint Economic Committee Holds Hearing on Realigning Health Care Incentives

On Wednesday, the Joint Economic Committee held a hearing on realigning health care incentives to improve outcomes and reduce costs. Witnesses at the hearing include Brooks Tingle of John Hancock Financial, Ed Clarke of Banner Health, Avik Roy of the Foundation for Research on Equal Opportunity, and Matthew Fiedler of the Brookings Institution Center on Health Policy. Read the witness testimonies here. 

Notable Bills Introduced:

Senator Marshall Introduces Bipartisan Pharmacy Benefit Managers Legislation

On Thursday, Senators Roger Marshall, M.D. (R-KS), Tim Kaine (D-VA), Chuck Grassley (R-IA), and Maggie Hassan (D-NH) introduced bipartisan legislation to establish clear fiduciary responsibilities for Pharmacy Benefit Managers (PBMs). The PBM Fiduciary Accountability, Integrity, and Reform Act (PBM FAIR Act) would require PBMs to operate as fiduciaries, obligating them to prioritize the financial and health interests of Employee Retirement Income Security Act (ERISA)-covered group health plans in every decision they make. Companion legislation was introduced in the House by Representatives Jake Auchincloss (D-MA) and Ryan Mackenzie (R-PA). Read the press release here and the bill here.

Senator Hassan Reintroduces Bipartisan Bill to Ensure No-Cost Contraception Coverage for All Women

On Thursday, Senators Maggie Hassan (D-NH), Lisa Murkowski (R-AK), Tammy Duckworth (D-IL), and Susan Collins (R-ME) reintroduced the Closing the Contraception Coverage Gap Act to close remaining coverage gaps. Currently, private insurance plans and Medicaid are required to cover all types of contraception, such as oral contraception and IUD insertion, at no cost to the patient; however, gaps remain. Read the press release here and the bill here.

Senators Budd, Hassan Introduce Bipartisan Bill to Lower Prescription Drug Prices

On Wednesday, Senators Ted Budd (R-NC) and Maggie Hassan (D-NH) introduced the bipartisan Biosimilar Inspection Modernization Act. The legislation would require the Food and Drug Administration (FDA) to develop a strategic plan for American biosimilars manufacturing, addressing FDA staffing challenges and improving internal and external communication. Read the press release here and the bill here.

Senator Cassidy Introduces Bill to Help Americans Plan for Life-Changing Illness

On Tuesday, Senator Bill Cassidy, M.D. (R-LA), introduced the Medicare Advance Planning (MAP) for Care Act to encourage Medicare beneficiaries to create electronic advance directives. The bill would encourage Medicare beneficiaries to create and register an online, certified, and secure advance directive and provide beneficiaries with access to a website offering a range of options. Read the press release here and the bill here.

Representatives Carey, Chu, & Senators Tillis, Hassan Reintroduce Bipartisan Legislation to Help Family Caregivers

On Tuesday, Representatives Mike Carey (R-OH) and Judy Chu (D-CA) and Senators Thom Tillis (R-NC) and Maggie Hassan (D-NH) reintroduced the Connecting Caregivers to Medicare Act. The legislation would publicize the resources Medicare provides to family caregivers, including the voluntary option that allows Medicare beneficiaries to authorize family caregivers to access certain information through 1-800-Medicare. Read the press release here and the bill here. 

Executive Branch:

HHS Announces Request for Information to Harness Artificial Intelligence to Deflate Health Care Costs

On Friday, the Department of Health and Human Services (HHS) announced a Request for Information (RFI) seeking broad public input on how HHS can accelerate the adoption and use of artificial intelligence as part of clinical care. The RFI invites stakeholders to provide feedback on how digital health and software regulatory frameworks should evolve to account for AI-driven tools while maintaining patient safety; how reimbursement structures can be simplified and better aligned to support the use of efficient, deflationary technologies; and how research and development investments can strengthen implementation science and best practices, especially for complex or high-acuity clinical scenarios. See the RFI here.

HHS Proposes Ending “Sex-Rejecting Procedures” for Minors

On Thursday, the Department of Health and Human Services (HHS) announced a series of proposed regulatory actions to carry out President Trump’s Executive Order directing HHS to end the practice of “sex-rejecting procedures” for minors. The Centers for Medicare & Medicaid Services (CMS) will release a notice of proposed rulemaking proposing to bar hospitals from performing “sex-rejecting procedures” for minors under age 18 as a condition of participation in Medicare and Medicaid programs. CMS will release an additional notice of proposed rulemaking to prohibit federal Medicaid funding for “sex-rejecting procedures” for minors. The same prohibition would apply to federal Children’s Health Insurance Program (CHIP) funding for these procedures on individuals under age 19. Read the CMS press release here.

CDC Adopts Individual-Based Decision-Making for Hepatitis B Immunization for Infants Born to Women Who Test Negative for the Hepatitis B Virus

On Tuesday, the Centers for Disease Control and Prevention (CDC) adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age. The child immunization schedule will be updated to reflect the recent recommendations by the CDC Advisory Committee on Immunization Practices, which were approved by Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O’Neill. The CDC will also update applicable clinical guidance for hepatitis B vaccines to reflect and implement the new recommendation. Read the press release here.

HHS Secretary Kennedy Adds Duchenne Muscular Dystrophy, Metachromatic Leukodystrophy to Newborn Screenings

On Tuesday, the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. today approved the addition of Duchenne Muscular Dystrophy (DMD) and Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP) following scientific review and public comment. The RUSP is the list of conditions the HHS secretary recommends for universal newborn screening. States choose whether to adopt each screening. Read the press release here.

HHS Secretary Kennedy Announces New Lyme Disease Diagnostic Efforts

On Monday, the Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz pledged to update the agency’s website to reiterate Medicare’s coverage of treatment for the tick-borne illness Lyme disease during a roundtable with Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. National Institutes of Health (NIH) Director Jay Bhattacharya also announced a clinical study with the Children’s National Hospital to investigate pediatric Lyme disease starting in early 2026. Read the press release here.