19 May 2025 This Week in Health Policy for May 19 Both the House and Senate are in session this week. The Budget Committee is expected to reconvene at 10 p.m. on Sunday to again consider the reconciliation measure. House Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade will hold a hearing on "AI Regulation and the Future of US Leadership" will hold a markup of "Budget Reconciliation Text"
Reconciliation update. On Friday (May 16), four hard-line conservatives blocked the House's budget reconciliation package in a Budget Committee vote, underscoring the task ahead for House Republican leaders to pass the bill out of the chamber by Speaker Mike Johnson's (R-LA) Memorial Day deadline. Among other concerns, Rep. Chip Roy (R-TX), criticized the bill's delayed cost-cutting changes to Medicaid, including work requirements on able-bodied adults to take effect in 2029, which he and other hard-liners want to see moved up. Leadership says they're open to moving up the start date along with other changes, but changing the bill to suit the conservatives' needs will be a balancing act as more moderate members are calling for an increase to the state and local tax deduction (SALT) limit and expressing reservations about cuts to Medicaid and the Supplemental Nutrition Assistance Program (SNAP). The House Budget Committee will reconvene at 10 p.m. on Sunday to again consider the measure and House Freedom Caucus members said they are continuing negotiations over the weekend. Earlier this week, the House Energy and Commerce Committee (E&C) passed their part of the bill out of committee. According to a preliminary estimate by the Congressional Budget Office (CBO) on the health subtitle of the bill, it would reduce the deficit by at least $715 billion over the 2025—2034 period and reduce the number of people with health insurance by at least 8.6 million in 2034. The bill includes a variety of provisions focused on reducing fraud, waste, and abuse in the Medicaid program, including a variety of changes to eligibility, enrollment and coverage; changes to provider taxes and state directed payments; imposition of work requirements for "able-bodied" individuals; and others addressing Affordable Care Act (ACA) eligibility and verification, changes to pharmacy benefit managers (PBMs) to enhance transparency, and other items. Additionally, the House Ways and Means Committee (W&M) bill includes a variety of health care items including those aimed at expanding and enhancing the use of Health Savings Accounts (HSAs) and other tax-preferred accounts, and provisions aimed at restricting certain immigrant's access to health care premium tax credits. CMS Innovation Center unveils new strategy. On Tuesday (May 13), the Center for Medicare and Medicaid Innovation (Innovation Center) unveiled a new strategy focused on prevention and helping people achieve healthier lives. The Innovation Center said it will focus future models on three interrelated pillars: promote evidence-based prevention, empower people to achieve their health goals, and drive choice and competition. Click here for a release and here for a blog by Innovation Center Director Abe Sutton. CMS proposes rule to change provider taxes rules. On Monday (May 12), CMS issued a proposed rule that aims to close what the administration calls a "Medicaid tax loophole" by changing the requirements around whether a provider tax can pass a certain test to prove that it is "uniform and broad based" and generally redistributive. The administration notes that certain states — including California, Michigan, Massachusetts, and New York — are imposing taxes on managed care organizations (MCOs) in way that only affects Medicaid business within those MCOs, leading to enhanced federal match rates. The rule proposes a timeline to transition states making use of the loophole based on the age of existing waivers. CMS is accepting comment on the proposed rule through July 14. CMS publishes draft guidance for 2028 drug price negotiations. On Monday (May 12), CMS released draft guidance for the third round of Medicare drug price negotiations. Among other items, the guidance language suggests that combination products which do not enhance efficacy may be negotiated 13 years after the original active ingredient was approved, rather than 13 years after combination approval. The guidance also aims to increase transparency in the program and includes instructions for including Part B drugs or biological products that have no generic or biosimilar competition. CMS also said that it could renegotiate prices for 2028 for drugs that have been negotiated for 2026 or 2027 if there are shifts in the drug's use or market exclusivity. The agency is accepting comments on the draft guidance through June 26. Trump admin indicates plan to roll back mental health parity rules. On Friday (May 9), the Trump administration in a new court filing said it will not enforce the Biden administration's mental health parity rule and is considering rescinding or modifying the rule. As such, the Trump administration asked the courts to pause a lawsuit challenging the rule. FDA to come out with vaccines framework. On Thursday (May 15), Food and Drug Administration (FDA) Commissioner Marty Makary said the FDA is preparing a new framework for vaccine makers to ensure predictability moving forward, which will likely come in the form of guidance in the next week or two. The announcement comes following the installation of Vinay Prasad as the FDA's new vaccine's chief. Prasad is known for criticizing mRNA and COVID-19 vaccines, questioning current clinical trial practices, and opposing the views of longtime vaccines director Peter Marks, who resigned in March. HHS and FDA seek comment on deregulation efforts. On Tuesday (May 13), the Department of Health and Human Services (HHS) and the FDA issued a Request for Information that seeks public input on "outdated or unnecessary regulations" that should be revised or eliminated. The RFI, which is part of a Trump administration initiative to eliminate 10 rules for every new one implemented, also asks about regulations that should be reconsidered to address MAHA and reverse chronic disease. The RFI will be open for comment for 60 days. HHS rescinds guidance documents. As a part of US Health Secretary Robert F. Kennedy Jr.'s overhaul of HHS and deregulation efforts, the agency rescinded Biden administration policy efforts on COVID-19 and gender identity bias protection. Biden administration guidelines on the administration of buprenorphine for opioid use disorder treatment and a 2001 action on opioid treatment were likewise repealed. FDA to launch comprehensive review of infant formula. On Tuesday (May 13), the FDA issued a Request for Information seeking public input on whether nutrition requirements for infant formula should be revised. FDA said the RFI will be the first step in a comprehensive review of infant formula. FDA to phase out certain fluoride supplements. On Tuesday (May 13), the FDA said it will conduct a scientific review of ingestible fluoride-containing supplements by late October with the goal of removing such products from the market. Trump admin seeks input on health IT modernization. On Tuesday (May 13), CMS and the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) issued a Request for Information (RFI) that public comment on the digital health product landscape for Medicare beneficiaries, as well as the state of data interoperability and broader health technology infrastructure. CMS/ASTP/ONC are accepting feedback from the public through June 16. EPA to keep Biden-era PFAS rules. On Wednesday (May 14), the Environmental Protection Agency (EPA) announced it will keep the Biden administration's National Primary Drinking Water Regulations (NPDWR) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS). The agency said it plans to issue proposed rulemaking this fall that would extend compliance deadlines to 2031. Trump signs Most Favored Nations EO. On Monday (May 12), President Trump signed an executive order (EO) on "Delivering Most-Favored-Nation (MFN) Prescription Drug Pricing to American Patients." The EO contains several directives aimed at ensuring the US gets the best price for prescription drugs, including: directing the US Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that drive price hikes in the US; facilitating direct-to-consumer purchasing at the MFN price; and instructing the Health and Human Services (HHS) Secretary to communicate MFN price targets to pharmaceutical manufacturers and undertaking actions if MFN pricing is not delivered. Such actions include proposing rules that impose MFN pricing, enabling drug importation from low-cost countries, and other actions including potentially revoking drug approvals and enforcement against anti-competitive practices. The EO and proposed activities are broader than those pursued by President Trump in his first term, and according to the fact sheet would expand efforts beyond Medicare to include Medicaid, in addition to instructing agencies other than HHS to act. The President proclaimed on Truth Social that the actions in the EO could cut drug prices "almost immediately, by 30% to 80%." Click here for a fact sheet. House Energy and Commerce Committee held a markup of "Budget Reconciliation Text". On Tuesday (May 13), the Committee approved four subtitles focused on energy, environment, communications and health. The Committee debated and voted down a host of Democratic amendments before approving the Health Subtitle (Subtitle D) of the bill by a vote of 30-24. The overall bill passed by a vote of 30-24 on May 14 at 4:28 PM, after more than 26 hours of consideration.
House Ways and Means Committee held a markup of reconciliation policies. On Tuesday (May 13), the Committee approved a nearly 400-page bill encompassing the full array of tax provisions and revenue offsets meant to accompany extensions of Tax Cuts & Jobs Act (TCJA) provisions expiring at the end of 2025 in a budget reconciliation bill. The Committee debated and voted down a host of Democratic amendments before approving the bill 26-19 on May 14 at close to 8 a.m., after more than 17 hours of consideration.
Senate HELP Committee and House Budget Committee held hearings on Fiscal Year 2026 Department of Health and Human Services Budget. On Wednesday (May 14), Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. ("RFK") testified before Congress for the first time as Secretary on the Fiscal Year (FY) 2026 HHS Budget. Throughout the heated hearings, Kennedy defended cuts to the agency as making progress towards President Trump's goal of shrinking federal spending and characterized cuts as an effort to streamline redundancies. Kennedy also denied accusations by Democratic lawmakers of withholding funds for life-saving government research and in response to questions about whether he is spending money that Congress allocated for specific causes, Kennedy said he will follow the law and spend money if lawmakers designate it for a certain program. Additionally, Democrats pressed Kennedy on his decision to cut funding to states for public health activities including vaccinations and he did not provide an answer when asked whether he would recommend the measles vaccine specifically. Lawmakers from both parties voiced concerns over the potential negative impacts of the proposed budget cuts and organizational changes on public health infrastructure. Senate Judiciary Committee held a hearing on PBM Power Play: Examining Competition Issues in the Prescription Drug Supply Chain. On Tuesday (May 13), the Committee heard from a panel of witnesses representing pharmacists, PBMs, providers and academics to discuss PBM competition. During the hearing, witnesses testified how PBM practices impact different elements of the health care industry, with specific focus on the impact on independent pharmacies and patient access to drugs. Senators on a bipartisan basis discussed potential reforms to the industry, from enhanced transparency to banning spread pricing. The committee also debated more radical measures, such as forcing PBMs to separate from insurance businesses or divest pharmacies to eliminate conflicts of interest.
Senate Finance Committee held a hearing to "Consider Favorably Reporting the Nominations of James O'Neill, of California, to be Deputy Secretary of Health and Human Services and Gary Andres, of Virginia, to be an Assistant Secretary of Health and Human Services." On Thursday (May 15), the Committee voted to advance the nominations of James O'Neill to be HHS deputy secretary and Gary Andres to be assistant secretary of HHS.
Document ID: 2025-1089 | |||
