Regulatory News
Centers for Medicare and Medicaid Services (CMS)
What the HHS regional offices closures mean for the health sector
The federal government is likely to be slower to perform basic yet vital functions when the Health and Human Services Department halves the number of regional offices that handle responsibilities such as Medicare claims appeals and safety inspections. HHS regional offices work closely with states, providers and health insurance companies to manage enforcement, compliance and myriad administrative tasks related to Medicare, Medicaid and other federal healthcare and public health programs. HHS announced it would close regional offices in Boston, Chicago, New York, San Francisco and Seattle as part of a sweeping departmental overhaul. The remaining offices in Atlanta, Dallas, Denver, Philadelphia and Kansas City, Missouri, will be expected to absorb a slew of new oversight and enforcement activities.
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CMMI models lost billions in aggregate, but some brought savings worth emulating: Avalere Health
Given ongoing stakeholder scrutiny as well as the Congressional Budget Office’s (CBO’s) 2023 fiscal assessment of CMMI’s impact and effectiveness, the Healthcare Leadership Council (HLC) commissioned Avalere to conduct a broader analysis of CMMI reflective of its expansive mission statement. Avalere evaluated 18 CMMI models by examining:
- Impacts on federal expenditures
- Effects on quality of care, and
- Level of transparency available during model design and implementation.
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An ‘insane’ calculus: A pharma company raised price for a rare disease drug 150% to cover Medicaid rebates
Eton Pharmaceuticals, argues there is no other way to keep its treatment on the market and make a profit. But its decision involves a calculated twist: a willingness to take a hefty loss on each Medicaid patient.
#Drug
When should six drugs count as one? The answer could be a big deal for pharma companies
Novo Nordisk argues the federal government should be forced to negotiate the price for six of its insulin products separately, even though they all contain the same active ingredient. The government says that the Inflation Reduction Act allows it to lump all these products together. Medicare also lumped together three Novo blockbuster diabetes and weight loss products — Ozempic, Rybelsus, and Wegovy — in the second round of negotiations. Semaglutide is the active ingredient in all of them.
#Drug, #Patient
Food and Drug Administration (FDA)
FDA Commissioner Marty Makary announces three new hires in leadership team
The commissioner of the Food and Drug Administration welcomed three new leaders to the agency this week: Lowell Zeta as deputy commissioner for strategic initiatives; Timothy Schell as acting director for the Center for Veterinary Medicine; and Craig Taylor as the acting chief information officer.
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FDA milk quality testing program suspended after job cuts
The Food and Drug Administration (FDA) is reportedly suspending a quality control program for testing of milk and other dairy products due to reductions in its food safety and nutrition division. According to Reuters, an internal email from the FDA’s Division of Dairy Safety stated that the agency was suspending its proficiency testing program for Grade “A” raw milk and finished products effective Monday.
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Key FDA drug data goes missing amid DOGE cuts
Food and Drug Administration databases that physicians and public health experts rely on for key drug safety and manufacturing information have been neglected due to DOGE-directed layoffs, leaving health professionals flying blind on basic questions about certain drugs they’re prescribing, current and former FDA officials tell Axios.
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The ‘revolving door’ between FDA and industry is spinning fast
Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry recruiters.
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US FDA limits industry employees from roles in its advisory committees
U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies regulated by the agency, such as pharmaceutical firms, from serving as official members on FDA’s advisory committees, where legally allowed.
#Drug, #Device
Health and Human Services (HHS)
DOGE slow-walks healthcare grants, takes over internal clearinghouse
A Department of Government Efficiency (DOGE) initiative called “Defend the Spend” has frozen healthcare grants, forcing government officials to individually approve each grant award to thousands of organizations relying on the funds. The effort is part of a broader push from the Trump administration to rein in spending and unilaterally cancel grants and contracts. Now, organizations and government agencies must include a justification for each grant.
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NIH grants plummeted $2.3 billion in Trump’s first months, as federal-academia partnership crumbles
The National Institutes of Health has scaled back its awards of new grants by at least $2.3 billion since the beginning of the year, with the biggest shortfalls hitting the study of infectious diseases, heart and lung ailments, and basic research into fundamental biological systems. This roughly 28% contraction in funding comes on top of threats to freeze billions of dollars of NIH funding to specific universities as well as abrupt terminations to hundreds of research projects on Covid-19, HIV/AIDS, health disparities, vaccine hesitancy, and other areas targeted by President Trump’s political agenda.
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NIH freezes funds to 5 universities
In a 16 April email seen by Science, an official from NIH’s Office of Extramural Research told grants managers to halt disbursements to Harvard, Brown, Northwestern, and Cornell universities, as well as Weill-Cornell Medical School. The Department of Health and Human Services (HHS), NIH’s parent agency, has also instructed NIH staff not to provide any communication to these institutions or to Columbia about whether the funds are frozen or why, according to the email.
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NIH moving to ban all future grants to universities with DEI programs or Israel boycotts, document suggests
The NIH is reportedly preparing to implement new rules that would tie funding eligibility to the presence of DEI programs or actions related to Israel. This proposed change represents a significant departure from the NIH’s traditional approach to grant funding, which typically focuses solely on the research merit rather than external programs or political stances.
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Harvard sues Trump administration over funding freeze
Harvard University sued the Trump administration on Monday, alleging that the government’s campaign to alter the school’s policies while cutting off research funding is unconstitutional.
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NIH director calls Trump’s anti-DEI orders ‘misunderstood,’ downplays reorganization plans
National Institutes of Health director Jay Bhattacharya on Monday asserted that the agency remains committed to research that advances the health of minorities — despite the Trump administration’s sharp focus on rolling back programs dealing with diversity, equity, and inclusion.
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U.S. Officials Might Not Cut Funding for Landmark Study of Women’s Health
Earlier this week the U.S. Department of Health and Human Services announced it will terminate contracts for the W.H.I.’s regional centers in September, effectively shutting down one of the largest studies on women’s health. However, on Thursday a federal official said the Department of Health and Human Services was reversing that decision, based on new National Institutes of Health budget numbers. The W.H.I. has been pivotal in changing medical practices and shaping clinical guidelines, preventing numerous cases of cardiovascular disease and breast cancer. It has enrolled over 160,000 women and currently tracks data from about 42,000 participants.
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RFK Jr.’s autism study to amass medical records of many Americans
In his effort to search for causes of autism, HHS Secretary Robert F. Kennedy Jr. will gain access to Americans’ private medical records and create a registry to track people with autism. The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments.
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SCOTUS Seems Inclined to Defent ACA Preventive Care Mandate
The word “independence” was heavily featured in Monday’s oral argumets before the Supreme Court on a case questioning the legitimacy of the Affordable Care Act (ACA) requirement that insurers cover certain preventive services free of charge to patients. The case, known as Kennedy v. Braidwood, involves Christian-owned businesses and six individuals in Texas who have challenged the ACA requirement to cover preventive services
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Trump’s first 100 days, seen through 5 lives: Grants terminated. Dreams crushed. Futures in the balance
In October, at a private event Russell Vought, laid out his plan to dramatically remake the federal government. It included defunding agencies, rolling back civil service protections, and generally just making life hell for government workers. “We want to put them in trauma,” he said. Over the past few months, STAT has been speaking with people living through the historic disruptions that are threatening the future of biomedical research in America. These are their stories.
Table of Contents
Chapter 1: The postdoc
Chapter 2: The university SVP
Chapter 3: The health equity researcher
Chapter 4: The lymphoma patient
Chapter 5: The NIH leader
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Day by day, how Trump is roiling science and health
It’s hard to remember all the earthshaking decisions and events that have transpired with unprecedented speed in the first few months of the Trump administration. We’re tracking, day by day, what’s happened in the worlds of science and health.
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Proposed HHS budget would close NINR, cut nursing programs
The American Nurses Association is warning that eliminating support for the training and research offered by the National Institute of Nursing Research could be devastating to the public, as many programs support specialties such as maternal and mental health.
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Hill Happenings
CRS Report on Office of Management and Budget (OMB) Reporting on Apportionments
Congress enacts annual appropriations and other budgetary legislation to provide agencies with budget authority, which allows them to spend federal dollars. To prevent agencies from prematurely exhausting their appropriated funds, the Antideficiency Act generally requires that appropriated funds be apportioned (i.e., subdivided)—by time period, function, program, or some combination thereof. Since 2022, OMB’s apportionment documents were available on the agency’s public website. Since March 24, 2025, that website is no longer available, and OMB Director Russell Vought said OMB will no longer make apportionments available on its public website.
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Senate HELP Committee Chair Cassidy Calls for Federal 340B Reforms, Releases Findings of Yearslong Congressional Probe
In September 2023, now-Chairman Bill Cassidy of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) initiated an investigation into the 340B Program. The investigation sought information from eight participants in the 340B Program in order to gain a comprehensive understanding of where the dollars generated by this program flow and how such revenue benefits patients.
#Drug, #Hospital, #Patient
Trump says he would veto Medicaid cuts
President Donald Trump said he would not sign legislation that calls for cuts to Social Security or federal health coverage for older and low-income Americans. “If it cuts it, I would not approve,” the president said in an interview with TIME magazine.
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Notable Notes
DOJ sends letter to medical journals asking about bias and ‘misinformation’
A letter sent by U.S. Attorney Edward Martin to several medical journals, requests information on how these journals plan to promote political diversity and avoid partisan bias. This request was prompted by allegations that some authors published in these journals have misled readers. A response is required by May 2, 2025. New England Journal of Medicine received a similar communication.
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Underweight TAVR patients face higher mortality risk—obesity makes no significant impact
Reviewing data from more than 6,000 patients, researchers found little evidence of the “obesity paradox” observed elsewhere. Underweight TAVR patients, however, may face some significant long-term risks.
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Former Trump official warns president he’s at risk of ruining his legacy on ending HIV
The health official who helped convince President Trump during his first term that it’s possible to end the HIV epidemic in the United States is now imploring the president to stay the course, as funding cuts threaten to undo progress toward curbing the virus. “Trump ’47 should not allow Trump ’45’s massive public health achievement to be cancelled — especially when that legacy will be remembered in history books as the beginning of the end of HIV/AIDS in America,” Brett Giroir, wrote on LinkedIn on Wednesday.
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ACS Publishes its Annual Report to the Nation on the Status of Cancer, featuring state-level statistics after the onset of the COVID-19 pandemic
This report represents a collaborative effort by the major cancer surveillance organizations to present the definitive US statistics for cancer incidence and mortality.Overall cancer mortality declined over 20 years, even during the COVID-19 pandemic. Disruptions in health care use early in the pandemic resulted in incidence declines in 2020, but 2021 incidence returned to prepandemic levels.
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Resilia tissue developed by Edwards Lifesciences linked to long-term benefits
Researchers tracked nearly 1,000 SAVR patients, presenting eight-year data at the Heart Valve Society’s annual meeting in Cairo, Egypt.
#Device, #Patient, #Provider
Oversizing reduces PVL when implanting Medtronic’s newer self-expanding TAVR valves
Paravalvular leak has been shown to impact patient outcomes after TAVR. Higher degrees of valve oversizing, however, can reduce the risk of post-treatment PVL without increasing the odds of adverse outcomes.
#Device, #Patient, #Provider
Myval TAVR valve non-inferior to Sapien 3 after 1 year—pacemaker implants the biggest difference
India-based Meril Life Sciences has been manufacturing its Myval transcatheter heart valves for years, but the technology has not yet gained FDA approval. This latest head-to-head comparison included data from more than 1,000 TAVR patients.
#Device, #Patient, #Provider
Opinion: Decentralized Clinical Trials: Embracing The FDA’s 2024 Final Guidance
The FDA’s 2024 guidance aims to standardize practices for DCTs, ensuring they meet regulatory requirements while promoting innovation in clinical research. Embracing these guidelines will enhance patient engagement, improve data quality, and streamline the clinical trial process. DCTs are able to reach diverse populations, thus improving the generalizability of trial results. While the guidance provides a framework, the article acknowledges challenges such as technology access, data security, and the need for robust training for trial staff.
#Patient, #Provider, #Drug
Is Lung Cancer Screening as Effective Without Risk-Based Selection?
New research indicates that LDCT screening in a broader population identified as many lung cancer cases as would typically be expected from screenings focused solely on high-risk individuals. Implications: This suggests that screening without risk-based selection could be just as effective in detecting lung cancer, potentially leading to earlier diagnoses and better outcomes.
#Provider, #Patient
Struggling lobbyists, panicked clients: D.C. comes to grips with Trump’s second term
Many lobbyists anticipated that Trump’s second term would mirror the first, involving regulatory adjustments and budget concerns. However, the reality has proven to be more complex and challenging. Within the first 100 days of Trump’s administration, substantial and unexpected changes have emerged, presenting unprecedented difficulties for health care companies and their lobbyists. The article highlights that the changes threaten the foundational government systems essential for the health care industry, including drug development, patient treatment, insurance provisions, and support for individuals with specific diseases.
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Vanderbilt medical center warns suppliers not to raise prices due to tariffs
Amid growing anxiety over tariffs, Vanderbilt University Medical Center has warned its suppliers that any sudden price hikes attributed to the levies will be rejected unless a company can justify its move — and even then, it may not get paid.
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