Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Opinion: By embracing technology, CMS’s innovation center can move faster and find success

In 2010, Congress launched the Center for Medicare and Medicaid Innovation (CMMI) to explore new payment models and help control healthcare costs. However, CMMI’s impact has been limited, with most initiatives failing to achieve significant savings, largely due to lengthy development and evaluation timelines. These delays result primarily from outdated processes and technology. By modernizing its approach, CMMI can streamline innovation, reduce costs, improve patient outcomes, and strengthen the federal government’s capacity to shape and respond to a rapidly evolving healthcare market.

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Hospitals and patient groups ramp up opposition to Medicaid cuts as House mulls options

Hospitals, health centers, and patient advocates this week plan to escalate their pressure on federal lawmakers to oppose cuts to the Medicaid program. The groups are increasing their public calls to lawmakers, standing up new collaborations, and increasing investments in advertising to discourage lawmakers from cutting hundreds of billions of dollars in the program.

#Hospital, #Patient

Medicare Advantage hits a snag in rural America

Private Medicare sign-ups are growing rapidly in rural America. At the same time, hospitals are increasingly refusing to accept the plans, saying private insurers pay too little and ask too much. The divergence is making it harder for older Americans to access already-limited care in the region — in some cases requiring them to drive hundreds of miles for medical services or switch back to traditional Medicare and risk losing benefits.

#Hospital, #Payer, #Patient

Food and Drug Administration (FDA)

Opinion: STAT+: A court decision on lab-developed tests sets a dangerous precedent

On March 31, Judge Sean Jordan of the Eastern District of Texas struck down the FDA’s final rule that established the agency’s regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs). This decision, which asserts that the FDA does not have responsibility for the authorization and oversight of LDTs, removes established guardrails for diagnostic safety and accuracy that protect patients, and sets a dangerous precedent for public health.

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Vinay Prasad tapped to run FDA center that regulates vaccines, gene therapies

Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply. Investors were not happy with the Prasad news, leading the XBI to fall over 6%. Shares of gene and cell therapy companies were particularly hard hit, with some plunging nearly 30%. In his first address to FDA staff on Wednesday, Vinay Prasad emphasized his commitment to evidence, his admiration for agency employees, and his desire to serve the American public.

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Five burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review

The Food and Drug Administration said it will rapidly roll out a generative artificial intelligence model to assist scientific reviews across the agency, setting up a high-stakes test of the technology’s use in vetting products used in the care of millions of Americans. Here are the questions that AI and health care experts most want answered about how FDA is planning on deploying generative AI in its review processes. What parts of the scientific review process are being automated? What safeguards are in place to protect proprietary information and ensure accuracy? How are FDA reviewers being trained to work with the technology?  What generative AI models were used to do the work, and how were they trained?  How will this get rolled out by the end of June?

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Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

The FDA’s decision has prompted plenty of questions about how patient care may be impacted and what happens next. This article represents an attempt to answer at least some of those questions.

#Device, #Patient, #Provider

Trump EO Aims To Boost U.S. Drugmakers, Crack Down On Foreign Facilities

President Donald Trump issued an executive order that aims to boost domestic drug manufacturing by directing FDA to provide early support to new U.S. drug facilities and the Environmental Protection Agency (EPA) to streamline requirements for companies building such facilities, while also ordering increased inspections and enforcement for foreign drugmakers.

#Drug

Health and Human Services (HHS)

White House releases 2026 ‘skinny budget’ calling for $33B in cuts to HHS

The White House’s “skinny budget” for 2026 proposes $33 billion in cuts to the Department of Health and Human Services (HHS) including significant funding reductions are proposed for the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). In contrast, the budget does not suggest any cuts to the Food and Drug Administration (FDA).

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HHS, NIH announce new ‘universal’ vaccine standard for broad-spectrum protection

HHS and NIH announced a new universal vaccine platform—dubbed “Generation Gold Standard”—that utilizes inactivated whole viruses to provide broad-spectrum coverage for seasonal illnesses such as COVID-19 and influenza. According to the May 1 announcement, the beta-propiolactone (BPL)-inactivated, whole-virus platform will allow for improved protection against more strains of these viruses, with future plans to expand its use to respiratory syncytial virus (RSV), metapneumovirus, and parainfluenza. Critics claim this program relies on antequated technology.

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20 attorneys general ask federal judge to reverse deep cuts to HHS

Attorneys general in 19 states and Washington, D.C., are challenging cuts to the U.S. Health and Human Services agency, saying the Trump administration’s massive restructuring has destroyed life-saving programs and left states to pick up the bill for mounting health crises.

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Opinion: Bristol Myers Squibb CEO: Pharmaceutical innovation requires bold yet predictable U.S. policy

We are motivated by the fact that our medicines can change the lives of patients. But that belief hinges on government policies that encourage highly risky investments and facilitate access. Right now, we have significant concerns that some potential policies surfacing in Washington could threaten the health of Americans and the U.S. economy.

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Opinion: The biotech industry needs to make its case for bold change to the White House

On April 15, President Trump issued an awaited executive order on drug pricing, kicking off a new frenzy among lobbyists and consultants. That frenzy has gone into overdrive with the latest proposal from the White House to examine cuts to Medicaid drug reimbursement, slashing prices to extortionate levels foreign governments demand. Unlike Trump’s first term, the pharmaceutical industry is in far more peril than it has ever been in, and the biotech industry needs to ask itself an important question: Where does it fit in Trump’s vision for a new American Golden Age?

#Drug

Cuts Have Eliminated More Than a Dozen U.S. Government Health-Tracking Programs

Over a dozen health-tracking initiatives have been discontinued due to funding cuts, raising concerns about the ability to effectively monitor health outcomes in the population. The reduction in data-gathering capabilities may hinder efforts to assess the effectiveness of health policies and initiatives aimed at improving public health.

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Opinion: What am I supposed to say to this generation of young scientists?

I hear these stories every day now. They are the subject of hallway conversations, lab discussions, and personal heartbreaks. This particular grant is just one of hundreds canceled at Columbia University, and thousands more across the country. At the institute I lead, almost all of the canceled grants were ones specifically awarded to support the training of young scientists. Each of these young scientists represents the future of American science: the next innovators, mentors, and developers of lifesaving treatments.

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Despite its cancer-fighting mission, NCI starts to feel Trump administration budget ax

The National Cancer Institute, 87 years old and burnished with a $7 billion annual budget and a mission to curb America’s second-leading cause of death, is the largest institute in the National Institutes of Health. At first, the NCI seemed to emerge relatively less affected by the cuts, terminations, and policy changes that rocked federal health agencies in the early months of the Trump administration.

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Axed federal employees sit on Capitol steps urging lawmakers to protect public services they used to provide

A group of former government workers goes to Capitol Hill weekly to lobby members of Congress to fight Trump’s federal workforce and program cuts.

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Kennedy launches US autism project using Medicare and Medicaid data

Federal health agencies will create a database of autism patients enrolled in Medicare and Medicaid that researchers will use to study the causes of autism spectrum disorder, U.S. Health and Human Services Secretary Robert F. Kennedy Jr said on Wednesday. The new platform will first focus on research around the root causes of autism, the Department of Health and Human Services said, and, in the long term, link data for research on other chronic conditions.

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Trump’s NIH Already Cut 694 Grants: These Centers Lost the Most

In the first few months of President Donald Trump’s second term in office, a whopping 694 NIH grants totalling $1.81 billion were terminated across nearly all of the agency’s institutes and centers, an analysis of NIH grant terminations found. The National Institute of Mental Health and the National Institute on Minority Health and Health Disparities lost the most grants, at 128 and 77 respectively. In terms of dollar amount, the National Institute of Allergy and Infectious Diseases lost the most in funding at $505,968,126, followed by the National Institute on Minority Health and Health Disparities at $223,566,041, they reported in JAMA. The only two centers spared by the cuts were the NIH Clinical Center and the National Center for Complementary and Integrative Health, they added.

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Drug tariffs could boost 340B discounts—and scrutiny

If tariffs are imposed on pharmaceutical ingredients sourced from countries like China and India, production costs could rise, leading to higher drug prices. Legal and policy experts suggest that higher drug prices could lead to larger discounts under the 340B program, which currently provides discounts of 25% to 50% on outpatient drugs. The program is already valued at approximately $66 billion.

#Hospital, #Drug

The American Hospital Association is urging CMS to adjust its newly established drug price negotiation program, arguing the agency’s current approach conflicts with 340B programs.

In a May 1 open letter to Kim Brandt, CMS’ COO, the hospital member group outlined concerns over a retrospective process established by the Biden administration to capture the maximum fair price of negotiated medications. The process, dubbed the Medicare Transaction Facilitator, compels medication dispensers to participate in the MTF payment module, but drugmakers are exempt.

“The retrospective process is complex, overly burdensome and operationally unworkable, particularly with respect to the critical 340B drug pricing program,” the AHA said. “

#Hospital, #Drug

White House seeks to cut funding for brain injury research

The White House’s proposed budget includes eliminating the Centers for Disease Control and Prevention umbrella agency responsible for TBI research, including the $8.25 million marked for brain injury research and public education about the dangers of concussions. The CDC is facing $3.59 billion in budget cuts.

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Research disrupted at the NIH Clinical Center

The National Institutes of Health Clinical Center, billed as the nation’s largest hospital devoted solely to medical research, is struggling to carry out its mission of running clinical trials for the hardest-to-treat diseases amid growing disruptions from the Trump administration. Fewer patients are being treated, and some trials are lagging months behind due to reduced staffing and uncertainty, according to STAT interviews with 11 staff members and researchers affiliated with the center.

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Hill Happenings

Opinion: ‘It’s not too late to do something about this’: An open letter from a leading vaccine advocate to Sen. Cassidy about RFK Jr.

Paul Offit, the director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, warns the physician-senator about the HHS secretary’s next moves

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Republicans are running out of ways to cut Medicaid as moderates and hard-liners clash

With a looming deadline from President Trump to find hundreds of billions of dollars in savings to fund tax cut extensions, some lawmakers are hinting at a potentially fraught approach to reducing Medicaid spending: rethinking who should be eligible in the first place. They say the program has grown to encompass coverage beyond its original intent and are taking aim at the inclusion of healthy adults with lower incomes in the program. House Speaker Mike Johnson confirmed on Tuesday that Medicaid cuts would be excluded from an upcoming spending bill, as both President Donald Trump and other Republicans in Congress opposed any reduction to funding.

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CBO  Estimates for Medicaid Policy Options and State Responses

The Congressional Budget Office responded to a request for estimates for five policy options concerning Medicaid and explains how the agency projects that states would respond to those policies. Under the first four policy options, federal contributions to the Medicaid program would be smaller, reducing federal budget deficits. CBO anticipates that states would respond in four ways:

• Spend more themselves on Medicaid, mainly using a mix of revenue increases and reduced spending on other programs for financing,
• Reduce payment rates to health care providers,
• Limit the scope or amount of optional benefits, and
• Reduce enrollment in Medicaid. Under a fifth policy option, which also would reduce the federal budget deficit, only Medicaid enrollment would be reduced as a result of the policy change.

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Democrats urge Republicans to target Medicare Advantage ‘upcoding’ instead of cutting Medicaid

As Republicans in Congress debate ways to cut Medicaid so they can fund tax breaks, Democrats are pushing them in a different direction: cut excess spending in Medicare Advantage instead.

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Prior authorization bills flounder despite bipartisan support

Despite bipartisan support for legislation aimed at limiting prior authorization requirements, efforts have repeatedly stalled in Congress. Lawmakers express hope that the current session may yield different results.

#Payer, #Patient, #Provider

Ways and Means Republican Members Share Commitment to Value-Based Health Care and Outline Priorities For CMMI

The Center for Medicare and Medicaid Innovation (CMMI) should return to its core mission and partner with the public to develop health care payment models that save taxpayer dollars and improve patient health – particularly for those in underserved or rural communities – write Ways and Means Committee Chairman Jason Smith (MO-08) and Committee Republican members in a new letter to the Centers for Medicare and Medicaid Services (CMS) Administrator Dr. Mehmet Oz and CMMI Director Abraham Sutton.

#Provider, #Patient

Notable Notes

Trump EO Bans Gain of Function Research Grants to Foreign Countries

Trump issued an executive order on Monday banning gain-of-function research in countries the White House says don’t have sufficient research oversight. Gain-of-function research involves altering pathogens to make them more transmissible or deadly so scientists can better study them.

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Europe Makes a Pitch to Attract Scientists Shunned by the U.S.

European countries are actively recruiting U.S. scientists who were fired by or had their funding stripped by the Trump administration, offering financial incentives.

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Bill Gates to wind down his massive foundation

Philanthropist Bill Gates announced Thursday that he will wind down his massive charity in 20 years, doubling spending over that time to accelerate the work it hopes to achieve. In a wide-ranging interview, he explains his decision — amid the Trump administration’s assault on foreign aid — to accelerate the end of his giving.

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Banning PFAS Would Jeopardize Millions of Medical Devices

A key component of life-saving medical devices has been placed in the crosshairs by government regulators, jeopardizing care for millions of Americans.State and federal policymakers are targeting a class of 15,000 chemicals known as perfluoroalkyl and polyfluoroalkyl substances, or PFAS. Best known for waterproofing and nonstick treatments.

#Device, #Patient

A super alternative: BATMAN helps cardiologists limit complications during TMVR

The BATMAN technique is a safe, effective way to prevent LVOT obstruction during high-risk transcatheter mitral valve replacement, according to new data presented at SCAI 2025.

#Device, #Patient, #Provider

Interventional Cardiology Frets Over Healthcare Policy Threats

Interventional cardiologists expressed frustration and pessimism for their field, and healthcare in general, in a perceived climate of financial instability. “It feels like a difficult time to be in healthcare and try to deliver exceptional care because of the financial pressures on the system,” said new Society for Cardiovascular Angiography and Interventionsopens in a new tab or window (SCAI) president Srihari Naidu, MD, of New York Medical College and Westchester Medical Center in Valhalla, New York, in an interview.

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How Much Should Doctors Dwell On Risks?

It’s not always clear that you’re really hearing—and absorbing—the medical information you need to know. To practice medicine ethically (and to avoid malpractice lawsuits), physicians must ensure that a patient has informed consent— that is, they must tell the patient enough information about the treatment or procedure for the patient to make an informed decision about their care. (It’s possible, of course, that in Gluck’s case, he did sign some form or another that mentioned those potential risks.) But how much information is too much? How little is too little? Informed consent laws don’t get into specifics, leaving the question up to individual doctors.

#Provider, #Patient