Policy Update – Week of November 11, 2024

Weekly Spotlight

The biggest news in health policy this week is incoming (and former) President Trump’s plan to nominate RFK Jr. for the top spot at HHS. This week’s spotlight features a roundup of the latest reporting on Trump and RFK’s top priorities for HHS.

Kennedy’s F.D.A. Wish List: Raw Milk, Stem Cells, Heavy Metals

Facing a dialogue with RFK Jr., a top FDA official mounts a public defense of vaccines

What Trump and Robert F. Kennedy Jr. might do to undermine vaccines — and what they likely can’t

What can Trump and RFK Jr. actually do on health care?

CDC director warns about RFK Jr.’s skeptical vaccine views

Health and science experts on their hopes and worries for the Trump era

How Trump’s approach to regulating AI in health care could diverge from Biden’s

Biotech and Donald Trump: A conversation about what comes next

Trump’s return raises concerns about funding cuts and politicization at the NIH

Trump’s return raises concerns about funding cuts and politicization at the NIH

Millions at risk of losing health insurance after Trump’s victory

Opinion: A second Trump administration will accelerate the undermining of the medical profession

Americans Have Regained Modest Trust in Scientists, Survey Finds

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

What Happens to Medicare Price Negotiations Under Trump?

The Inflation Reduction Act (IRA) allowed Medicare to negotiate prescription drug prices for the first time — a reform long sought by progressive Democrats. Under President-elect Trump, the future of the program is less certain. But if there’s one thing that experts agree on, it’s that whole-cloth repeal of the law won’t be easy.

#DRUG, #PATIENT

We’re going to have to fix this ourselves’: 5 CFOs on navigating Medicare Advantage

Medicare Advantage now provides health coverage to around 55% of the nation’s seniors, but some hospitals and health systems are choosing to end contracts with some MA plans due to administrative hurdles. The most frequently cited challenges include high prior authorization denial rates and delayed payments from insurers.

#PAYER, #HOSPITAL

Private Medicare plans collect billions for care veterans are actually getting from VA

Medicare Advantage (MA) plans are increasingly enrolling veterans. Because MA plans receive full capitated payments regardless of whether or not veterans use Medicare services, the federal government can incur substantial duplicative, wasteful spending if veterans in MA plans predominantly seek care through the Veterans Health Administration (VHA) system.

#PAYER, #PATIENT

In a twist, Medicare Advantage insurers try to avoid selling plans to seniors

Aetna, Cigna and Elevance Health sell Medicare Advantage plans. But that doesn’t necessarily mean they want people to buy them.

#PAYER, #PATIENT

The Sickest Patients Are Fleeing Private Medicare Plans—Costing Taxpayers Billions

Medicare Advantage patients in the last year of life were far more likely to switch to traditional Medicare, shifting costs from insurers

#PAYER, #PATIENT

Payment cuts and beyond: Key takeaways for cardiologists from the 2025 Medicare Physician Fee Schedule

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals.

#PROVIDER

SCCT Leaders Unpack the 2025 Medicare Payment Increase for Coronary CTA

The Society of Cardiovascular Computed Tomography (SCCT) is cheering as a “huge win” the 2025 CMS payment increase for coronary CTA that more than doubles the current payment and “better aligns with the cost of providing CCTA services,” according to a statement earlier this month. CCTA utilization is expected to increase significantly throughout the U.S. Here’s a snapshot

#PROVIDER

Food and Drug Administration (FDA)

He’s the F.D.A.’s Cancer Chief, Not a Fortune Teller

Many patients can live longer and better lives than ever seemed possible. Cancer death rates have been plunging, and researchers attribute most of that to improved treatments. Overseeing this change at the Food and Drug Administration has been Dr. Richard Pazdur, currently the director of the Oncology Center of Excellence. Trained as an oncologist, he leads the agency and its cancer specialists in determining how cancer drugs are tested and approved.

#DRUG, #PATIENT, #PROVIDER

Health and Human Services (HHS)

How lawsuits may reshape 340B reimbursement

Johnson & Johnson sued the federal government, claiming the Health Resources and Services Administration does not have the authority to restrict how the drug manufacturer can distribute 340B drug discounts. The pharmaceutical company seeks to charge 340B-enrolled disproportionate share hospitals full price for its anticoagulant Xarelto and the Crohn’s disease medication Stelara and administer discounts later, rather than at the time of purchase.

#DRUG, #HOSPITAL

Hill Happenings

Moderate GOP senators: Don’t ask me about confirming RFK Jr.

Moderate Republican senators, are reluctant to criticize Robert F. Kennedy Jr.

With GOP control of Congress, Trump has broad power to reshape health care

A number of major issues are potentially at stake, including subsidies for Affordable Care Act plans, Medicaid funding, access to telehealth, how Medicare pays doctors, drug middlemen reforms, and China’s rise in biotechnology.

#ALL

Incoming Senate Majority Leader Thune hails from a state that relies on rural hospitals, telehealth

Sen. John Thune (R-S.D.), the newly elected Senate majority leader, is big on telehealth, rural hospitals, and increasing transparency for drug middlemen. As majority leader, Thune will be in charge of coordinating the entire Republican policy agenda, and it’s not clear how health care will fit into the mix.

#ALL

PBM bill, telehealth extension may ride together in ‘lame duck’

Congress has tried for much of the last two years to pass legislation to rein in pharmacy benefit managers. With lawmakers back for a post-election lame duck session, analysts see one last chance — but also a likelihood the effort may wait until Republicans take control of Capitol Hill next year.

#ALL

CBO: Monthly Budget Review Summary for Fiscal Year 2024

The federal budget deficit increased 8 percent, or $138 billion, in fiscal 2024 — with Medicare and Medicaid seeing increases.Medicare outlays rose $78 billion, or 9 percent, because of higher enrollment and payment rates for services. Medicaid outlays also rose but on a smaller scale: $2 billion, or less than 1 percent, even as states revisited who was eligible for Medicaid

#ALL

MedPAC backs tying physician pay to inflation, but ducks specifics

Commissioners debated different solutions to lackluster physician pay with one theme in common: linking doctors’ annual payment update to the Medicare Economic Index.

#PROVIDER

MedPAC Tackles Accuracy of Medicare Advantage Network Directories

Inaccuracies in Medicare Advantage (MA) directories listing in-network providers — often criticized as being too “narrow” — and flaws in rules governing them need to be addressed to prevent situations that are “horrible,” “unfair,” and can harm beneficiaries, some members of MedPAC said during its public meeting Friday.

#PAYER, #PATIENT, #PROVIDER, #HOSPITAL

Notable Notes

Trump Likely to Undo Several of Biden’s Executive Orders on Health

Orders restoring WHO membership, aiding reproductive health access likely on the chopping block

#ALL

New data put a spotlight on troubling TAVR trends

EARLY TAVR showed that early treatment for asymptomatic patients with severe aortic stenosis (AS) can improve outcomes, but it also served as a reminder that AS is such a deadly disease because so many patients never receive proper care. There are even times when when an echo is ordered and a patient qualifies for transcatheter aortic valve replacement (TAVR), but they still go untreated.

#DEVICE, #PATIENT, #PROVIDER

Self-expanding vs. balloon-expandable TAVR valves: How they compare after 5 years

SOLVE-TAVI focused on the long-term impact of selecting different second-generation transcatheter heart valves and anesthesia strategies for transfemoral TAVR procedures.

#DEVICE, #PATIENT, #PROVIDER

Tricuspid TEER shows clinical efficacy for first time in newest TRILUMINATE data / Cardiology societies push Medicare to pay for tricuspid TEER

New TRILUMINATE IDE data presented at TCT 2024 confirmed efficacy for the first time for Abbott’s TriClip device in treating tricuspid regurgitation (TR). The initial results from the first 350 patients in the trial, presented as a key late-breaker at ACC.23, led to the FDA approval of the Abbott TriClip in April 2024. However, that data only showed that patients reported feeling better with an improved quality of life; it did not show clinical efficacy. The American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS) all signed on to a 13-page letter to CMS outlining why T-TEER should be reimbursed.

#DEVICE, #PROVIDER

AMA calls for tougher oversight of nonprofit hospitals

The federal government should require nonprofit hospitals to justify their tax-free status with standardized charity care programs, the American Medical Association says.

#HOSPITAL, #PROVIDER

Private equity firms upping investment in hospital ASCs

On the heels of news that private equity is investing less in private practice, private equity firms are increasingly investing in hospital-owned ambulatory surgery centers, allowing the companies to bankroll a growing sector while limiting regulatory scrutiny.

#HOSPITAL, #PROVIDER, #PATIENT

Cardiovascular health disparities persist in puzzling ways, studies find

At AHA, new studies on Wegovy prescriptions, maternity care, and DEI programs

#PATIENT

As adult survivors of congenital heart defects grow in numbers, so does need for care and research

Children with congenital heart defects who used to die in infancy or childhood now survive and even thrive into adulthood. But as people in this cohort grow older, they may leave the care of pediatric cardiologists only to find doctors whose training may not have included care of adult survivors like them.

#PATIENT

Cardiologist demand is on the rise—can hospitals keep up?

Demand for inpatient and outpatient cardiology services is expected to increase significantly in the next decade, putting hospitals and health systems in a position where they need to plan ahead or risk falling behind.

#PROVIDER, #HOSPITAL, #PATIENT