14 July 2025 This Week in Health Policy for July 14 The House and Senate are in session this week. The Senate could take up the House-passed recissions package, raising the potential for another vote-a-rama in the Senate. House and Senate committees also will continue work on annual federal appropriations, which must be addressed by September 30 to avoid a government shutdown. On the regulatory side, CMS is expected to soon issue proposed rules for the Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Physician Fee Schedule (MPFS). Senate Homeland Security & Governmental Affairs Subcommittee on Investigations will hold a hearing on "Voice of the Vaccine Injured."
House Energy and Commerce Subcommittee on Health will hold a hearing on "Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-the-Counter Medicines."
Senate HELP Committee will hold a nominations hearing on Brian Christine to be HHS Assistant Secretary for Health and others.
President Trump signs H.R. 1 into law. On July 4, President Donald Trump signed the GOP reconciliation bill into law. The Senate passed H.R. 1 on July 1, in a 51-50 vote with Vice President J.D. Vance casting the tie-breaking vote after a marathon "vote-a-rama" on amendments and motions that lasted more than 24 hours. The House then worked through the scheduled Fourth of July holiday recess to pass the Senate's amended version in a 218-214 vote on July 3. The final version of the bill includes key changes to Medicaid, health savings accounts, the IRA's drug price negotiation program, and more. The final bill did not include PBM reforms — including 'delinking' in Medicare Part D, a ban on spread pricing in Medicaid, or PBM transparency and reporting requirements, a provision to bar state regulatory action on AI, funding for cost-sharing reduction subsidies on the ACA exchanges, and other policies included in previous versions. For a comprehensive overview of the bill's health care provisions see the attached WCEY Alert - Health Care Provisions in Reconciliation Bill. Lawmakers are now considering next steps regarding a potential second reconciliation package. In addition, Rep. Buddy Carter (R-GA) has introduced the PBM Reform Act, a bipartisan bill that includes several PBM reforms left out of the reconciliation bill and from a year-end package in 2024, but that have broad bipartisan support. Griffith takes over Energy and Commerce Health Subcommittee. Rep. Morgan Griffith (R-VA) has taken over as chair of the House Energy & Commerce Subcommittee on Health, following Rep. Buddy Carter's (R-GA) resignation to pursue a Georgia Senate seat. Rep. Griffith's appointment could reduce Subcommittee activity related to PBM reform. He is expected to prioritize rural health care access, GOP-backed Medicaid reforms and investigation into Covid-related concerns like limiting gain of function research House Oversight Democrats probes ACIP changes. On July 10, House Oversight Committee Democrats sent a letter to CDC Chief of Staff Matthew Buzzelli demanding a briefing from Centers for Disease Control and Prevention (CDC) staff by July 17 after the sudden replacement of all 17 members of the agency's Advisory Committee on Immunization Practices (ACIP) with eight appointees who are considered to be skeptical of vaccines. The letter also requested documents by July 24 explaining how and why each member was chosen. Select Committee probes biotech links to China. On Tuesday (July 8), the House Select Committee on China leaders sent a bipartisan letter to the directors of the FBI and national intelligence, reiterating concerns about GenScript Biotechnology's ties to China, according to Reuters. Makary ties new voucher program to international prices. In an interview airing Friday (July 11) with Bloomberg Television's Wall Street Week, Food and Drug Administration (FDA) Commissioner Marty Makary said the agency may fast-track new drugs from pharmaceutical companies that "equalize" the cost of their medicines between the US and other countries. The FDA last month announced the Commissioner's Nation Priority Voucher Program (CNPV) to accelerate drug approvals, and the comments suggest the agency may look to use that program as part of efforts related to international reference pricing. Makary highlights first 100-day actions. On Thursday (July 10), FDA Commissioner Marty Makary published a statement highlighting actions taken to improve transparency and advance "gold-standard science" during his first 100 days leading the agency. FDA publishes decision letters on drug applications. On Thursday (July 10), the FDA published more than 200 complete response letters (CRLs) related to drug and biological product approval applications between 2020 and 2024. FDA said the effort aims to increase transparency into FDA decision-making around application rejections. HHS action to remove illegal immigrants from federal programs. On Thursday (July 10), the Department of Health and Human Services (HHS) rescinded a 1998 interpretation of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) that extended certain federal public benefits to undocumented immigrants. Instead, HHS said it will rely on PRWORA's plan-language definition of "Federal public benefit" and published a list of programs that are included, including community health centers and Head Start, which were effectively exempt previously. FTC ramps up action on gender-affirming care for minors. On Wednesday (July 9), the FTC hosted a workshop on unfair or deceptive trade practices in 'gender-affirming care' for minors. The event featured doctors, medical ethicists, whistleblowers, and others who shared their perspectives. The event follows FTC sending warning letters to providers advising patients on gender-affirming care for minors. FDA updates drug importation guidance. On Tuesday (July 8), the FDA updated guidance for state importation program (SIP) under Section 804 of the Federal Food, Drug, and Cosmetic Act that provides additional steps states may take as part of their applications, including that states may consider tariffs to have a neutral impact when determining their cost savings. NIH caps scientific journal publisher fees. On Tuesday (July 8), the National Institutes of Health unveiled a new policy to cap excessive publisher fees including article processing charges, for NIH-supported scientists to publicly publish their work. NIH said it will introduce the new cap in FY 2026. DOJ, USPS launch whistleblower program targeting health and drug prices. On Tuesday (July 8), the Department of Justice's (DOJ) Antitrust division, in partnership with the US Postal Service, launched a Whistleblower Rewards Program to encourage reporting of criminal antitrust violations, such as price fixing, bid rigging, and market allocation, across industries ranging from healthcare to agriculture FDA issues draft guidance on clinical trial design for disease-modifying drugs. The FDA issued draft guidance for developing disease-modifying drugs and biologics to treat myelodysplastic syndromes (MDS), focusing on clinical trial design, patient selection, safety reporting, and efficacy endpoints. As part of the draft guidance, sponsors are advised to enroll diverse patient populations and consider alternative safety reporting methods for expected adverse events like cytopenia's. Trump teases pharma tariffs. On Tuesday (July 8), President Trump during a Cabinet meeting reiterated that the US will soon impose tariffs on pharmaceutical products. "We'll be announcing something very soon on pharmaceuticals," he said. "We're gonna give people about a year, year and a half to come in, and after that they're gonna be tariffed if they have to bring the pharmaceuticals into the country … They're going to be tariffed at a very, very high rate, like 200 percent." Commerce Secretary Howard Lutnick told CNBC after the meeting that details on pharmaceutical tariffs "will come at the end of the month." Trump further delays country-specific tariffs. On Monday (July 7), President Trump signed an executive order (EO) setting August 1 as the new end date for the suspension of additional country-specific tariff rates on countries with which the US has large trade deficits and trade barriers, initially announced as part of President Trump's April 2 'Liberation Day' announcement. The country-specific tariffs are intended to replace the 10% rate currently applied to nearly all trading partners and imports. The suspension of the tariffs, first announced by the President on April 9, was previously slated to end Wednesday (July 9). Federal workers. On Tuesday (July 8), the Supreme Court issued an order allowing the Trump administration to enforce a February 11 executive order that instructed federal agencies, including HHS, to implement "reductions in force" RIFs while litigation continues. The order, which does not rule on merits of the case, lifts an injunction issued by U.S. District Judge Susan Illston, who had blocked 21 agencies, including HHS, from complying with the mass layoff orders in May. COVID-19 vaccines. On Monday (July 7), a coalition of doctors' groups led by the American Academy of Pediatrics filed a lawsuit Monday against Health Secretary Robert F. Kennedy Jr., arguing that his May announcement that the government would no longer recommend Covid vaccines for healthy pregnant people and children violated longstanding norms governing U.S. immunization policy. "The Secretarial Directive is contrary to the wealth of data and peer-reviewed studies that demonstrate the safety and efficacy of Covid vaccines for children and pregnant women," the plaintiffs said in the lawsuit. Organizations on the challenge include the American College of Physicians, the American Public Health Association and the Infectious Diseases Society of America. Planned Parenthood funding. On Monday (July 7), a federal judge in Massachusetts granted Planned Parenthood's request for a temporary injunction against a provision in the reconciliation bill barring state Medicaid payments to health care nonprofits primarily engaged in family planning services or reproductive services that offer abortion care and received more than $800,000 in federal funding in 2023. The judge, whose ruling only applies to Planned Parenthood, said the organization had shown "good cause." DOJ, HHS launch working group on health care fraud. On July 2, the Department of Justice (DOJ) and HHS announced the 'False Claims Act Working Group' to enhance coordination in pursuing health care fraud. The group will focus on several priority areas including drug and biologics pricing (i.e. arrangements for discounts, rebates, service fees, and formulary placement and price reporting), as well as kickbacks related to drugs. DOJ, FTC hosts listening session on anticompetitive practices in pharma. On June 30, DOJ and the Federal Trade Commission hosted the first of three listening sessions titled "Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition." The session focused on how practices such as reverse-payment settlements, product hopping, and patent thickets delay lower-cost generics and biosimilars. Panelists suggested solutions including stronger antitrust enforcement, legislative reforms to curb low-value patents, streamlining biosimilar interchangeability, and addressing PBMs' role in driving up drug costs. The next two listening sessions are:
CMS to test prior auth in Medicare. On June 27, The CMS Innovation Center announced a new 6-year model designed to test prior authorization for select items in traditional Medicare. The Wasteful and Inappropriate Service Reduction (WISeR) Model, which will begin in 2026, will test prior authorization for certain Part B services in traditional Medicare for providers in the following states: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington. Participants will be companies with expertise providing recommendations on medical necessity of coverage for payers using enhanced technology like AI. Applications are due July 25. ONC announces deregulation effort. The Office of the National Coordinator for Health IT announced it would not enforce some regulations related to certified electronic health records as part of President Trump's executive order (EO 14192) on reducing regulatory burdens. As part of the action, ONC said certified EHR makers in 2025 no longer have to submit plans for real-world testing of their systems' ability to transmit and receive data. Senate Appropriations Committee held a markup of "Commerce, Justice, Science; Agriculture, Rural Development, FDA; and Legislative Branch Appropriations Acts." On Thursday (July 10), the Committee voted 27-0 to pass a bill that funds the FDA at FY 2025 levels. The bill provides the FDA with $7 billion, comprised of $3.6 billion in taxpayer funds and $3.4 billion in user fee revenues and also raises concerns about some FDA practices, including hiring restrictions and the agency's stakeholder roundtable discussions. The funding level is up from the $6.8 billion the House Appropriation Committee's bill provided to FDA, which aligned with President Trump's budget request.
The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing to consider the nomination of Susan Monarez. On Wednesday (July 9), the Committee voted 12-11, along party lines, to advance President Trump's nomination of Susan Monarez as Director of the Centers for Disease Control and Prevention (CDC). The nomination now moves to the Senate floor for final confirmation.
The Senate HELP Committee held a hearing on "Future of Health Care: Protecting Americans' Health Privacy." On Wednesday (July 9), the Committee held a hearing that focused on improving cybersecurity in health care and safeguarding sensitive patient information. The Committee heard from witnesses representing consumer watchdogs, consumer technology organizations, health systems, and public health. Chairman Bill Cassidy outlined proposals to modernize HIPAA, extend privacy safeguards to cover these gaps, and leverage AI and advanced data tools to support patients and rural health care providers. During the hearing, witnesses discussed the challenges rural hospitals face in meeting cybersecurity standards, while members from both political parties spoke of the need to improve privacy protections.
Senate Appropriations Committee held a hearing on "A Future Without Type 1 Diabetes: Accelerating Breakthroughs and Creating Hope." On Wednesday (July 9), the committee heard from a panel of patients with Type 1 diabetes who discussed their experiences, and the director of the National Institute of Diabetes and Digestive and Kidney Disease who discussed research into the condition. During the hearing, Democrats and Republicans spoke of the need to reauthorize the NIH Special Diabetes Program beyond its current September 2025 expiration. Democrats also expressed concern about how proposed cuts to NIH funding and other Administration changes would impact diabetes research.
Document ID: 2025-1535 | |||
