Blog | 8/1/2025

Trump Administration Healthcare News: August 1, 2025

Health Advances weekly healthcare tracker focused on top level government administration news.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on July 31, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

The U.S. is destroying $9.7 million in contraceptives.

  • The State Department has confirmed plans to destroy millions of dollars' worth of taxpayer-funded contraceptives meant for women in low-income countries. The controversial move comes as the Trump administration continues to scale back foreign aid.
  • A stockpile of family planning products — including IUDs, implants and pills — worth $9.7 million has been stuck at a warehouse in Belgium since the administration dismantled the U.S. Agency for International Development (USAID) and froze foreign aid earlier this year, according to statements from multiple humanitarian groups and U.S. lawmakers.
  • The products' expiration dates range from 2027 to 2031, according to Doctors Without Borders (Médecins Sans Frontières, or MSF) and the reproductive health care nonprofit MSI United States.
  • In a statement shared with NPR, the State Department confirmed that the U.S. will spend $167,000 to destroy the contraceptives at a French facility that handles medical waste.
  • "Only a limited number of commodities have been approved for disposal," it said, adding that no HIV medications or condoms are being destroyed.
  • In its statement to NPR, the State Department referred to them as "abortifacient birth control commodities" — referring to substances that cause the termination of a pregnancy.
  • A U.S. policy called the "Mexico City Policy," instituted by President Ronald Reagan during a 1984 conference in that city, restricts foreign nongovernmental organizations from using U.S. federal funds to provide abortion services or related information. Presidents have alternately rescinded and reinstated the policy since its creation; most recently, President Trump brought it back at the start of his second term.
  • https://www.npr.org/sections/goats-and-soda/2025/07/28/nx-s1-5482742/the-u-s-is-destroying-9-7-million-in-contraceptives-is-there-another-option

KEY FEDERAL GOVERNMENT NEWS

Vinay Prasad is out at FDA, following Sarepta decision and vaccine controversies

  • Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, has suddenly left the agency, Endpoints News has learned.
  • A spokesperson for HHS confirmed his exit. “Dr Prasad did not want to be a distraction to the great work of the FDA in the Trump administration,” according to the HHS spokesperson, who said that Prasad has “decided to return to CA and spend more time with his family.”
  • Prasad didn’t immediately respond to attempts to reach him for comment Tuesday night. He joined the FDA in May to lead CBER, and soon after took on the role of chief medical and scientific officer.
  • His surprise exit follows a volatile two-week period in which the agency forced Sarepta Therapeutics to pull its gene therapy for Duchenne muscular dystrophy after several patient deaths, then suddenly backtracked and allowed the drug back on the market for some patients.
  • Prasad has also been closely involved in the regulation of Covid-19 vaccines, repeatedly overruling the FDA’s scientific reviewers on several occasions.
  • https://endpoints.news/vinay-prasad-out-at-fda-after-agency-backtracks-on-sarepta-decision/    (subscription required for full text)

FDA taps newly appointed George Tidmarsh as acting CBER leader after Vinay Prasad exit

  • Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes.
  • Freshly appointed Center for Drug Evaluation and Research (CDER) leader George Tidmarsh M.D., Ph.D., will now take on the role of acting director of CBER as well, according to an internal letter from FDA Commissioner Marty Makary, M.D., to staffers that was viewed by Fierce.
  • Both departments fall under the FDA’s umbrella, with CDER covering most small-molecule and biological therapeutics while CBER oversees vaccines, cell and gene therapies and other blood products.
  • The letter also announced Scott Steele, Ph.D., and Brittany Goldberg, M.D., as deputy directors of CBER.
  • University of Rochester professor Steele has served as a senior advisor for CBER since 2022, while infectious disease physician Goldberg was the division's chief medical officer for 13 years. Both served as acting CBER directors before Prasad’s appointment.
  • The FDA did not respond to Fierce’s requests for comment about conducting a search for a permanent leader.
  • https://www.fiercepharma.com/pharma/fda-taps-newly-appointed-george-tidmarsh-cber-leader-after-prasad-exit

CMS negotiates with insurers as Medicare premiums set to rise

  • Medicare Part D premiums will increase next year, the Centers for Medicare & Medicaid Services (CMS) announced as the agency adjusts a Biden-era program.
  • The national average monthly bid amount, used by the government to calculate subsidies to plans, will increase from $179.45 to $239.27.
  • In a news release Tuesday, CMS said it took “unprecedented action” against insurers engaging in large premium increases. The feds negotiated bid terms and denied certain bids, the agency said.
  • “Following these negotiations, CMS approved some revised bids and, for the first time, rejected standalone [Part D premium] bids that failed to address concerns regarding significant year-over-year premium increases and that were also market outliers compared to similar plans in the same region,” the press release reads.
  • Premiums were capped from increasing more than 6% due to a provision in the Inflation Reduction Act (IRA) that will be in effect through 2029.
  • https://www.fiercehealthcare.com/payers/cms-negotiates-insurers-medicare-premiums-set-rise

US Senate confirms Trump nominee Susan Monarez as CDC director

  • The U.S. Senate voted on Tuesday night 51-47 along party lines to confirm President Donald Trump's nominee, Susan Monarez, as director of the Centers for Disease Control and Prevention, charged with leading the response to threats against public health.
  • Monarez, a career public health official who served as acting director of the CDC until her nomination, will report to Secretary of Health and Human Services Robert F. Kennedy Jr.
  • Monarez, the first CDC director without a medical degree since 1953, holds a PhD from the University of Wisconsin-Madison. Her research focused on developing technologies to diagnose, treat and prevent infectious diseases.
  • Monarez will lead a diminished agency, with the White House seeking to cut the CDC's budget by almost $3.6 billion, leaving it with a $4 billion budget, and Kennedy enacting a layoff plan that cut 2,400 employees, though some 700 were rehired.
  • https://www.reuters.com/legal/litigation/us-senate-confirms-trump-nominee-susan-monarez-cdc-director-2025-07-30/

RFK Jr. plans to remove all members of US Preventive Services Task Force: WSJ report

NIH is shrinking the number of research projects it funds due to a new Trump policy

  • The National Institutes of Health plans to shrink the share of grant applications it will award for the remaining two months of the fiscal year due to a new Trump administration policy — in some cases, by more than half compared to the previous year.
  • The National Cancer Institute, for example, informed scientists last week that it expected to be able to fund just 4% of grant applications, down from 9%. The policy change, affecting multiple branches of NIH, will ratchet up competition for grants to an unprecedented level. And unless Congress steps in, the more restrictive policy will continue in the budget year starting Oct. 1.
  • The policy will affect R01 grants, which represent the bulk of federal funding for universities and medical centers, and are often described as the “basic building blocks” of scientific research. These grants are awarded to scientists who run labs and are the basis for funding their graduate students, post-docs, equipment, and materials, and sometimes their own salaries. Not included are certain early-career grants and training grants.
  • https://www.statnews.com/2025/07/29/nih-cancer-institute-shrink-number-of-funded-research-grants/   (subscription required for full text)

Kennedy pledges to 'fix' the federal vaccine injury compensation program

  • HHS Secretary Robert F. Kennedy Jr. said he intends to “fix” the federal program for compensating vaccine injury claims, which he says has “devolved into a morass of inefficiency, favoritism, and outright corruption.”
  • Prior to HHS, longtime anti-vaccination advocate Kennedy made millions of dollars by referring people with vaccine injuries to potential court cases. Building on that work, Kennedy says he’s working to revamp the Vaccine Injury Compensation Program (VICP) and put vaccine developers on the hook for more compensation, with expedited payments to claimants.
  • Created in the 1980s, the VICP is a no-fault alternative to court proceedings to resolve vaccine injury petitions. The program has paid out more than $5 billion since its inception thanks to a trust fund endowed by a 75 cent surcharge for every vaccine, according to Kennedy.
  • “But the VICP no longer functions to achieve its Congressional intent,” Kennedy wrote on X. He said the defendants in these cases should be the vaccine makers and not the federal government, and noted that judges who work in the program “prioritize the solvency of the HHS Trust Fund, over their duty to compensate victims.”
  • Press: https://endpoints.news/kennedy-pledges-to-fix-the-vaccine-injury-compensation-program/   (subscription required for full text)
  • Analysis: https://www.axios.com/2025/07/28/rfk-jr-vaccines

FDA developing new flu vaccine framework to tackle 'problems,' senior official says

  • The FDA is working on a new flu vaccine framework, which a senior FDA official told Endpoints News would address “a lot of problems” related to strain selection, year-over-year changes in efficacy, and the specific assays to evaluate effectiveness that are “a little antiquated.”
  • The official also raised the possibility of additional regulatory action on a chikungunya vaccine sold by Valneva, citing safety concerns.
  • The move toward a new flu framework comes as FDA Commissioner Marty Makary last month predicted a universal flu vaccine will be available within the next five years, “including potential bird flu variants.” Clinical trials for universal influenza vaccines are expected to begin next year, with FDA approval targeted for 2029, according to HHS.
  • https://endpoints.news/fda-developing-new-flu-vaccine-framework-to-tackle-problems-senior-official-says/   (subscription required for full text)

Trump admin creates hepatitis C care model, releases $100M pilot funding opportunity

GOP tax-spending bill sets path for direct primary care boost

  • Providers of "direct primary care" who charge patients a monthly fee for unlimited visits and workups are poised to become big winners from the new Republican tax-and-spending law.
  • Why it matters: The law for the first time allows patients to tap their health savings accounts for the concierge-like primary care arrangements, and lets employers extend both benefits, in the belief they're more efficient than the traditional fee-for-service system.
    • The change aligns with a Project 2025 goal to promote more personalized and flexible direct primary care, and a GOP penchant for expanding the use of high-deductible health plans and their tax-advantaged savings accounts.
    • The legislation "takes an impediment out of the way" for employers who want to improve their employees' primary care, said Jim Winkler, chief strategy officer for the Business Group on Health.
  • Driving the news: Starting next year, people who have a high-deductible plan and direct primary care membership through their workplace can contribute to an HSA.
    • The ability to invest pre-tax dollars and spend them later on eligible health care expenses can lessen the burden of a large insurance deductible.
    • About 21% of U.S. workers with employer-sponsored health insurance were enrolled in HSA-eligible high-deductible plans in 2024, according to KFF.
  • Until now, the tax code disqualified people who use concierge care from contributing to an HSA. Employers are among those who advocated for the change, which had some bipartisan support, Winkler said.
  • The bill also makes direct primary care membership fees an allowable HSA expense for people who don't get a subscription through their employer.
  • The change opens the direct primary care market to more employers, said Rebecca Springer, director of market development at health care investment bank Bailey and Co.
  • https://www.axios.com/2025/07/31/gop-tax-spending-bill-direct-primary-care

Living HHS Open Data Plan Published, HealthData.gov Refreshed to Provide Greater Transparency, Encourage Innovation, and Eliminate Information Silos

  • The U.S. Department of Health and Human Services (HHS) today announced the publication of its Living HHS Open Data Plan and the rollout of a refreshed HealthData.gov website marking a transformative milestone in the Department’s commitment to transparency, innovation, and data-driven decision-making.
  • “Since the Trump Administration began, HHS has more than tripled the number of datasets on HealthData.gov—from approximately 3,000 in January 2025 to over 10,000 today,” said Deputy Secretary Jim O’Neill, who leads technology and innovation programs at the agency.
  • These initiatives, led by the HHS Chief Data Officer (CDO), align with the OPEN Government Data Act and the broader goals of the Foundations for Evidence-Based Policymaking Act (Evidence Act) signed by President Trump in January 2019.
  • The refreshed HealthData.gov website features improved data quantity, enhanced data quality, and three new HHS assets for public use: the HHS Open Data Plan (Version 1.0), the HHS Metadata Standard (Version 1.0), and the HHS Data Inventory (Version 1.0).
  • https://www.hhs.gov/press-room/living-open-data-plan-healthdatagov-launch.html

Court orders continued Medicaid funding to Planned Parenthood

  • A federal judge in Massachusetts on Monday ordered the federal government to continue Medicaid funding for Planned Parenthood affiliates, writing that the health organization was likely to prevail in a dispute over President Trump's tax-and-spending law.
  • Why it matters: The order came after U.S. District Court Judge Indira Talwani last week froze a funding ban in the law for a subset of Planned Parenthood clinics that receive less than $800,000 from Medicaid annually or that don't perform abortions.
  • Driving the news: Talwani on Monday wrote that patients are likely to suffer adverse health consequences if care the organization provides is disrupted, including an increase in unintended pregnancies, complications from reduced access to contraceptives and more undiagnosed and untreated STIs.
    • Planned Parenthood members stand to lose over a third of their aggregate revenue because they are barred from receiving Medicaid reimbursements, the order states.
    • The way the law forces clinics to sever ties with the Planned Parenthood Federation and stop providing abortion as a condition for continuing to participate in Medicaid imposes a choice that "kneecaps the entire organization," Talwani wrote.
    • Planned Parenthood sued the Trump administration early in July over a provision in the tax-and-spending law that cut off large organizations that offer abortions from federal Medicaid funding for one year.
  • https://www.axios.com/2025/07/28/massachusetts-court-medicaid-planned-parenthood-ruling-trump

KEY REVERSALS – RESCINDED ITEMS

White House walks back NIH grant blocks

  • The White House has reversed a short-lived directive for the National Institutes of Health to halt funding for new research grants — a move that would have paused nearly $15 billion in federal funds that support health research, according to a report from The Washington Post, which is based on internal emails and interviews with federal officials familiar with the situation.
  • On July 29, the Office of Management and Budget sent NIH officials a document with a footnote stating that, while the OMB was allotting the NIH its “full-year apportionment” of congressionally mandated funds, the money could only be used to cover salaries, administrative expenses and clinical center expenses. The footnote stated that funding for research grants, research and development contracts, and training awards “cannot be issued during this pause.”
  • Four hours later, a spokesperson for the OMB confirmed funds were released, meaning the NIH is able to continue releasing funds for research grants. Sen. Patty Murray, D-Wash., who sits on the Senate Appropriations Committee, said the move would have put a freeze on $15 billion in federal funds if it was not reversed.
  • In June, President Donald Trump released the proposed fiscal budget for 2026, calling for a 40% reduction in funding for the NIH. The agency has terminated billions of dollars in grants to universities and academic medical centers since January.
  • https://www.beckershospitalreview.com/legal-regulatory-issues/white-house-walks-back-nih-grant-blocks/

KEY LAWSUITS

States sue to stop Trump administration from defunding Planned Parenthood

  • More than 20 states filed a lawsuit Tuesday against the Department of Health and Human Services, challenging a provision in President Trump’s enormous tax and spending package that bars certain health care nonprofits from receiving Medicaid reimbursements. 
  • The One Big Beautiful Bill Act (OBBA) includes a provision that bars health care nonprofits that provide abortions and received more than $800,000 in federal funding in 2023 from being able to get Medicaid reimbursements for one year. 
  • The provision primarily impacts Planned Parenthood affiliates, but at least two other organizations that provide abortion care will also be affected: Maine Family Planning and Health Imperatives in Massachusetts.
  • The coalition behind the lawsuit includes Pennsylvania Gov. Josh Shapiro, along with 21 attorneys general, such as New York’s Letitia James and Maine’s Aaron Frey. Lawmakers are seeking a court order declaring the OBBA provision unconstitutional and pausing its implementation.
  • https://thehill.com/regulation/court-battles/5426272-states-sue-hhs-planned-parenthood-defunding/

KEY BIOPHARMA NEWS

Trump demands pharma CEOs implement 'most favored nation' pricing within 60 days

  • President Donald Trump stepped up his campaign to get large drugmakers to lower their prices, posting letters to more than a dozen major pharma companies demanding that they bring their US prices in line with what they charge abroad, as well as other steps.
  • Trump gives these companies 60 days to comply or else he says he will “deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices.” He posted the letters on his account on Truth Social.
  • The letters were addressed to top executives at Pfizer, AbbVie, Boehringer Ingelheim, Novartis, Gilead, EMD Serono, Novo Nordisk, Bristol Myers Squibb, Amgen, Genentech, Johnson & Johnson, GSK, Merck, Regeneron, Sanofi, Eli Lilly and AstraZeneca.
  • “Today’s letters indicate that industry proposals have fallen short,” the White House said in a statement. The companies have been meeting off and on with the administration since the White House announced the policy earlier this year.
  • In the letters, Trump demands that the companies give Medicaid, the US health program for low-income people, access to similar and lower prices to what the companies charge in other developed economies. He tells the companies to match prices for new drugs to foreign introductory prices, and to repatriate any new, higher revenue gained abroad back to the US. And he told them to make the drugs available for direct sale to consumers.
  • https://endpoints.news/trump-demands-pharma-ceos-implement-most-favored-nation-pricing-within-60-days/

Trump's pharmaceutical tariffs materialize at last in new US-EU trade deal

  • As part of a trade agreement reached Sunday between the U.S. and the EU, pharmaceutical imports—along with almost all goods entering the U.S. from the bloc—will be subject to a 15% tariff, according to a White House fact sheet issued Monday.
  • The baseline 15% rate is separate from the sector-specific tariffs President Donald Trump has proposed multiple times this year, and it isn’t entirely clear how those sectoral tariffs—and the results of a Section 232 investigation into the national security implications of U.S. pharmaceutical imports—might add to or replace the rate agreed to on Sunday.
  • The U.S. Department of Commerce did not respond to Fierce Pharma’s request for clarification by publication time.
  • Another potential hitch is how the U.S. defines “pharmaceuticals” under the trade deal, and whether that label includes all pharmaceutical products or just finished drugs. Certain generic drugs are excluded under the current plan, though it isn’t immediately clear which ones, according to analysts at Jefferies and multiple news reports.
  • All told, the trade deal could cost the pharmaceutical industry between $13 billion and $19 billion, Reuters reported, citing analyst commentary. Nevertheless, the outcome is “‘less bad’ than expected,” the Jefferies team wrote in a note to clients Monday.
  • The 15% tariff rate on pharmaceuticals and other goods provides the industry with clarity and should be manageable for major drugmakers, most of whom already have significant manufacturing operations in the U.S., the Jefferies analysts explained.
  • Importantly, the tariffs have not yet gone into effect and will not until the conclusion of the Trump administration’s Section 232 investigation into pharmaceutical imports, according to the Jefferies note. The outcome of that probe—the likes of which have been used to impose tariffs on imports like steel and automobile parts in the past—is due by August, CNBC reported Tuesday.
  • Press:  https://www.fiercepharma.com/manufacturing/trumps-pharmaceutical-tariffs-materialize-last-new-us-eu-trade-deal
  • Analysis:  https://www.axios.com/2025/07/29/drug-prices-tariffs-eu-trumpWhite
  • House Fact Sheet: https://www.whitehouse.gov/fact-sheets/2025/07/fact-sheet-the-united-states-and-european-union-reach-massive-trade-deal/

FDA, ASCO propose principles for proper dosing in cancer drug development

  • The US Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) have laid out several principles for cancer drug developers to ensure more nuanced dosing. The principles are intended to help sponsors develop drugs that are better tolerated by patients who otherwise might suffer from long-term exposure and toxicity.
  • Historically, cancer drugs have used the maximum tolerated dose (MTD) or the highest dosage administered in the dose-escalation regimen if an MTD isn’t stated.
  • However, using MTD when determining the proper dosage has significant side effects, including increased toxicity and intolerability for patients.
  • To come up with better dosing for cancer drugs, FDA and ASCO have proposed five principles that drug sponsors should consider using. First, they propose collecting and using more expansive patient safety and tolerability data. They said that more expansive safety data could include the type and frequency of adverse events (AE) data, timing of the AEs, and collecting data on lower-grade toxicities.
  • FDA and ASCO also proposed that sponsors should tailor their drug development plans to the characteristics of the drug and the intended patient population.
  • Press: https://www.raps.org/News-and-Articles/News-Articles/2025/7/FDA,-ASCO-propose-principles-for-proper-dosing-in
  • ASCO article: https://ascopubs.org/doi/full/10.1200/JCO-25-00488

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

OIG Approves Free Companion Diagnostic Testing Program for Enzyme Inhibitor Drug

  • The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion 25-07) regarding a pharmaceutical manufacturer’s program to sponsor free companion diagnostic testing for certain oncology patients.
  • Though the program implicates the federal Anti-Kickback Statute (AKS) and could generate prohibited remuneration if the requisite intent were present, OIG concluded that the program poses a sufficiently low risk of fraud and abuse.
  • For the same reasons, OIG concluded that the program would not generate prohibited remuneration under the Civil Monetary Penalty Law (CMPL) because it satisfies the “Promotes Access to Care” exception to the CMPL.
  • The advisory opinion addresses a straightforward sponsorship arrangement. The manufacturer is obligated contractually to pay a laboratory to perform a next-generation sequencing-based companion diagnostic test for eligible patients.
  • The test is required by the drug’s labeling and determines whether a patient’s tumor exhibits a particular genetic deficiency that would make them a candidate for the manufacturer’s drug.
  • https://www.healthindustrywashingtonwatch.com/2025/07/articles/fraud-and-abuse-developments/oig-approves-free-companion-diagnostic-testing-program-for-enzyme-inhibitor-drug/#page=1

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

White House and CMS to launch Health Tech Ecosystem Initiative to expand use of digital health with a focus on consumers

  • The White House and the Centers for Medicare and Medicaid Services announced they secured voluntary commitments from 60 healthcare technology organizations, including Amazon, Anthropic, Apple, Google, and OpenAI, to work collaboratively on a new health tech advancement initiative. The 60 companies will deliver results in the first quarter of 2026, though what those deliverables look like remains to be seen.
  • The “Make Health Tech Great Again” meeting was hosted by President Donald Trump, Health Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz. At the meeting, CMS revealed voluntary criteria for data exchange that will be accessible by health information networks and exchanges, electronic health records and tech platforms.
  • The administration has two focus areas: a CMS interoperability framework and increasing the availability of personalized tools. The administration has a clear focus on consumers and support for individual access to electronic health records.
  • Prominent payers and provider organizations signed the pledge, including Cleveland Clinic, CVS Health, Intermountain, Providence, Aetna, Elevance Health, Humana and UnitedHealth Group.
  • Health tech companies, which form the Health Tech Ecosystem Initiative, include Anthropic, Hippocratic AI, Microsoft AI, Zocdoc, Oura, Oracle, b.well Connected Health and Samsung. In the diabetes and obesity category are Noom, Virta Health and Welldoc, among others.
  • Joining the Health Tech Ecosystem is a voluntary commitment to a “standards-based digital health environment” that will integrate apps, electronic health records and providers with the Centers for Medicare and Medicaid Services’ (CMS) Aligned Networks. It puts a focus on making digital health tools user-friendly and valuable to patients and providers.
  • A total of 30 companies will assist with apps to manage diabetes and obesity, use conversational AI agents and replace paper intake forms with digital check-in. Eleven provider organizations will participate and support patient use. Seven EHRs pledged to share data and “help ‘kill the clipboard.’”
  • Press:  https://www.fiercehealthcare.com/regulatory/white-house-and-cms-launch-health-tech-ecosystem-initiative-expand-use-digital-health
  • CMS Press: https://www.cms.gov/newsroom/press-releases/white-house-tech-leaders-commit-create-patient-centric-healthcare-ecosystem

KEY MEDTECH NEWS

For AI-based ‘breakthrough’ medical devices, Medicare coverage may become easier

  • Medical device lobbyists and lawmakers have united in recent months over legislation that would make it easier to bill Medicare for artificial intelligence-based devices used in health care. They want to grease the squeaky wheels of reimbursement for “algorithm-based health services,” many of which have seen limited adoption despite getting cleared by the Food and Drug Administration.
  • Some clinical AI products could reach the market through an even more streamlined mechanism, though, if another pathway for innovative medical devices is created.
  • Since the first Trump administration, politicians and regulators have pitched the idea of automatic Medicare coverage for “breakthrough” devices, an FDA designation that aims to encourage innovation for unmet patient needs. The Centers for Medicare and Medicaid Services proposed, and then scrapped, a rule that would offer up to four years of coverage for FDA-authorized breakthroughs. But the idea has recently resurfaced in proposed legislation, with support from health agency leaders. FDA commissioner Marty Makary has said he is working with CMS administrator Mehmet Oz to advance immediate Medicare reimbursement for breakthroughs, “so they don’t have to go through their own repeat duplicative process.”

KEY ACRONYMS

  • CDC = Centers for Disease Control and Prevention
  • CBER = Center for Biologics Evaluation and Research
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • HSA = heath savings accounts
  • IRA = Inflation Reduction Act
  • IUD = intrauterine devices
  • MDUFA = Medical Device User Fee Amendments
  • MSF = Médecins Sans Frontières (Doctors without Borders)
  • NIH = National Institutes of Health
  • OBBA = One Big Beautiful Bill Act
  • OMB = Office of Management and Budget
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • USAID = U.S. Agency for International Development
  • USPSTF = U.S. Preventive Services Task Force

Share this: