Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Medicaid Cuts Could Shift Up to $1.1 Trillion in Costs to States

If federal Medicaid spending per enrollee is capped, states will have to make up for an estimated $700 billion to $1.1 trillion in funding reductions from the federal government over the next ten years, according to a new analysis by the Urban Institute, supported by the Robert Wood Johnson Foundation.

#All

Trump defends drug price negotiation program in Novartis lawsuit – Fierce healthcare

The Trump administration, perhaps surprisingly, chose to defend the legality of the Inflation Reduction Act’s (IRA’s) drug price negotiation program enacted under President Joe Biden.

In a filing Feb. 19, the government agreed with the legal arguments used by the prior administration and by a lower court, dealing a blow to pharmaceutical drugmakers enraged by the program.

#Drug

Rainfall Health Leverages AI to Help Health Systems Achieve Compliance with CMS-Required TEAM Model

Rainfall Health, a leader in AI-driven healthcare solutions, is revolutionizing how health systems, from major institutions to rural health centers, achieve compliance with the Centers for Medicare & Medicaid Services (CMS) mandated TEAM model. By integrating cutting-edge artificial intelligence, Rainfall Health is making it seamless for healthcare organizations to drive better patient outcomes while maximizing reimbursement.

#Hospital

Medicare Advantage enrollment growth slows drastically

The number of people enrolled in a private Medicare Advantage plan grew just 3.1% from 2024 to 2025 — well below projections from the federal government and Wall Street, and one of the slowest years of growth ever in the program.

#MEDICARE

Food and Drug Administration (FDA)

Device industry scrambles amid concern FDA layoffs will cause delays

The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an attorney said.

#Device

FDA rehires staff to its medical devices division after mass layoffs – MSN

The Trump administration is reinstating some employees in the Food and Drug Administration’s medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative led by billionaire Elon Musk and his Department of Government Efficiency, according to two people familiar with the matter.

#Device

Medical device recalls hit a four-year high in 2024. Here’s why

Medical device recalls surged last year, driven by stricter FDA oversight and a big jump in the most serious type of recalls.

#Device

Cardiologist questions FDA’s approval process for high-risk medical devices

Sanjay Kaul, MD, a cardiologist with Cedars-Sinai Medical Center in Los Angeles, shared his perspective in JACC: Cardiovascular Interventions, an American College of Cardiology journal.[1] Kaul pointed to several recent examples to make his point. He started with the 2024 approvals of the Evoque transcatheter tricuspid valve replacement system from Edwards Lifesciences and the TriClip transcatheter edge-to-edge valve repair system from Abbott.

#Device, #Provider, #Patient

Opinion: STAT+: There’s a better way to get drugs on the market: progressive approval

The public and pharmaceutical companies are calling for changes in drug regulation and the costs of medicines. They are right to do so. Companies want to see products approved faster for financial reasons, and patients want medicines that can improve their lives. The two are inextricably tied, and realizing those goals requires tossing out the broken system we have in exchange for a superior system that is richer in data and evidence. It also means that we all have to embrace the simple truth that taking these chemicals will always come with risk.

#Drug

FDA cancels meeting to choose flu vaccine strain

The Food and Drug Administration (FDA) abruptly canceled a vaccine advisory meeting where members were slated to discuss influenza vaccine strains. The meeting was scheduled for March 13. Committee members received an email informing them of the cancellation Wednesday afternoon with no rescheduling information and no reason given for the cancellation,

#Patient

Health and Human Services (HHS)

“Making America Healthy Again”: The impact on the FDA, life sciences, and healthcare sectors – DLA Piper

President Donald Trump recently issued an Executive Order (EO) establishing the President’s Make America Healthy Again (MAHA) Commission. The EO, issued on February 13, 2025, addresses a range of issues, including chronic disease and obesity in adults and children, the increased diagnosis of mental health conditions and the impacts of prescription treatments, the effects of technology use on healthy lifestyles, and the impact of food production, ingredients, and chemicals on health outcomes. Our alert examines some of the key areas of impact.

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NIH cancels summer internship program

The National Institutes of Health usually welcomes around 1,200 students onto its campuses each summer, but this year will be an exception. In an internal email obtained by STAT, the agency announced that it is cancelling its Summer Internship Program, also known as SIP, even though some students had already been accepted.

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STAT+: Some NIH study sections will resume reviewing grants, but final funding decisions are still in limbo

After weeks of being blocked by the Trump administration, one crucial step in the National Institutes of Health process for funding biomedical research is being largely restored, but it seems that won’t immediately allow new grants to be approved and resume the flow of millions of dollars to universities and medical schools.

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Opinion: RFK Jr.’s dangerous misuse of ‘informed consent’ on vaccines

Kennedy wants future vaccine communications to focus on “informed consent,” by which he means giving people information about the adverse events associated with vaccines. That’s a distorted view, one that demonstrates broader confusion about informed consent and the goals of public health. True informed consent requires an understanding of how people process information about risks, and public health must promote collective benefits rather than focus entirely on individual autonomy.

#Patient

Hill Happenings

Congress Turns Attention to PBM Reform, Sort of

Congress came within inches of enacting major pharmacy benefit manager restrictions in December. Supporters see an opportunity to try again. However, at what was supposed to be a hearing to discuss PBM reform, some in Congress veered off into discussions about Medicaid and maternal health, and even Elon Musk.

#Drug

A bill is reintroduced in Congress to revise provisions in drug-pricing law

Once again, House lawmakers have introduced a bill to alter a key provision of the Inflation Reduction Acthttps://www.statnews.com/pharmalot/2025/02/25/medicare-pills-biologics-pharmaceuticals-medicine/ in response to arguments that the federal law is discouraging investment in developing so-called small molecule medicines.

#Drug

Senator seeks to double hospital price transparency fines

Louisiana  Sen. John Kennedy has reintroduced legislation that would increase fines for hospitals violating federal price transparency rules. President Donald Trump also signed an executive order Feb. 25 aimed at boosting healthcare price transparency.

#Hospital

Hospitals urge lawmakers to act as Medicare telehealth policies near expiration

A group of healthcare advocates, including hospitals and health systems, are urging Congress to act quickly to keep telehealth services available for millions of Americans

#Hospital

Notable Notes

The other physician pipeline problem

There are countless projections about the worsening U.S. physician shortage, especially as the aging population grows and requires higher acuity care. Lots of attention is paid to supporting the medical student pipeline, but the healthcare industry might be overlooking the other end: retirements.

#All

The COVID ‘Contrarians’ Are in Power. We Haven’t Hashed Out Whether They Were Right.

In October, Stanford University professor Jay Bhattacharya, MD, PhD, hosted a conference on the lessons of COVID-19 in order “to do better in the next pandemic.” He invited scholars, journalists, and policy wonks who, like him, have criticized the U.S. management of the crisis as overly draconian.

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STAT+: Why NIH pays universities far more for indirect costs than private foundations

One of the key justifications the Trump administration has offered for its bombshell proposal to sharply cut what the National Institutes of Health pays research grant recipients for overhead costs is that most private organizations place similar restrictions on funding for what’s known as indirect costs. This is true, but scientific funding experts told STAT the comparison is not a fair one — and plaintiffs challenging the policy change in federal court have made a similar argument. While the 15% cap on indirect costs proposed by NIH is on par with what most foundations pay, universities have gone along with taking significantly less than their actual overhead costs from private sources because they get much more of their research dollars from the federal government. Private foundation funding serves as a beneficial add-on.

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Know your options: What cardiologists recommend when alternative access is required for TAVR

Transfemoral TAVR is not always a viable option. In those instances, the two most effective alternatives are transcarotid access and transcaval access, according to a new SCAI expert consensus statement.

#Device

Popular TAVR valves linked to comparable long-term outcomes

Second-generation TAVR valves from Medtronic, Edwards Lifesciences and Boston Scientific are all associated with similar seven-year outcomes, according to a new retrospective study out of Italy.

#Device, #Patient

An updated look at the use of cerebral embolic protection devices during TAVR

Cardiologist Aakriti Gupta, MD, MSc, spoke to Cardiovascular Business about the latest data and trends associated with using cerebral embolic protection devices during TAVR to lower the risk of stroke.

#Device, #Patient, #Hospital

Trump is looking for drugmakers to come through for him. They have a wish list for him, too

After announcing plans to build four manufacturing sites in the U.S. on Wednesday, Eli Lilly chief executive officer Dave Ricks skillfully demurred when asked if the move might forestall tariffs that President Trump has threatened to levy on the pharmaceutical industry.

#Drug

Robotic surgery gains ground inside hospitals

Medtech giants are doubling down on robotic surgery systems as hospitals see fewer complications and shorter stays.

#Hospital

Humana looks to deepen meaning of ‘value-based care’

Few buzzwords are as popular in healthcare as “value-based care.” But understanding of the term is often superficial, according to Alex Ding, MD, enterprise deputy chief medical officer at Humana.

#Hospital, #Patient