Policy Update – Week of November 18, 2024

Introduction
This week: Trump nominations continue to roll out.

Weekly Spotlight

The Trump transition is in full effect, with the nomination of Dr. Oz to head the all-important Centers for Medicare and Medicaid Services and Martin Makary likely to be tapped to lead the Food and Drug Administration. Reports suggest that providers groups are staying mum or at least measured in responding to the nomination of RFK Jr. as head of the Department of Health and Human Services. Meanwhile, Elon Musk and Vivek Ramaswamy have begun to outline their plan to reform government under the new “Department of Government Efficiency” (DOGE). In a new opinion piece, they suggest that the Supreme Court’s recent reversal of the Chevron doctrine will guide their efforts to “reverse a decadeslong executive power grab.”

Some of the easiest targets for DOGE (which isn’t actually a government agency) and/or the Republican establishment include any of the regulations promulgated in the last 60 legislative days of the Biden Administration. Under the Congressional Review Act Congress may review and disapprove any “major” federal agency rules for a period of 60 legislative days. This 60-day period counts every calendar day, including weekends and holidays, but excludes days that either chamber is out of session for more than three days pursuant to an adjournment resolution. This means that the new Republican-controlled Congress can overturn anything the Biden team finalized from approximately May 22, 2024 forward.

Nominations of RFK Jr. and Dr. Oz have put “science” back at the top of health policy minds. In the wake of the U.S. election, National Academies of Science President Marcia McNutt authored an editorial in Science stressing the apolitical nature of science and emphasizing that science, although not the only consideration, remains vital to informing public policy and stating that rebuilding public trust in science in an era of political divisiveness is critical. This while Pew reports that Americans are divided about what role scientists should play in crafting public policies and

MedTwitter migrates en masse to the social media platform Bluesky.

Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

Biden’s prior authorization reforms divide providers, insurers

The Biden administration sought to tackle one of the most contentious policies in healthcare: prior authorization. Providers and insurers say there’s still room for improvement.

#Payer, #Provider

RFK Jr. is exploring a plan to upend Medicare’s physician payments system

People close to Robert F. Kennedy Jr. are exploring a proposal that could upend how physician payment is determined in America. The policy would reduce the role played by the American Medical Association Relative Value System Update Committee (AMA-RUC), in determining what Medicare pays for medical services.

#Provider

Value-based models picked up steam in 2023: 5 numbers to know

The percentage of healthcare risk dollars in two-sided risk arrangements grew across all types of health plans in 2023, according to the Healthcare Payment Learning and Action Network’s annual report.

#Provider, #Hospital

CMS releases 200 new Medicare residency slots

The slots are part of the first increases in graduate medical education funding since 1997, but the industry still faces ongoing physician shortages.

#Provider, #Hospital

Food and Drug Administration (FDA)

Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products – Looking Forward

Experts will discuss the current and future activities of FDA’s Real-World Evidence (RWE) Program for drugs and biological products. RWE holds the potential to advance regulatory decision-making, but implementation challenges and opportunities for improvement remain.

#Drug

Health and Human Services (HHS)

Drugmakers’ 340B rebate fight, explained

Johnson & Johnson and Eli Lilly both sued the federal government this month over the future of their respective 340B drug rebate plans.

#Drug, #Hospital

RFK Jr. vs. Vivek: Trump world’s two paths for pharma regulation

Between Robert F. Kennedy Jr. and Vivek Ramaswamy, the incoming Trump administration has divergent views on regulating the pharmaceutical industry.

#Drug, #Patient

DEA, HHS to extend remote prescribing for another year

The Drug Enforcement Administration is set to once again extend a COVID-19 era rule that allows clinicians to remotely prescribe controlled medications, such as Adderall and Vicodin.

#Drug, #Patient, #Provider

HHS sued over public access to Medicare Advantage audit records

KFF Health News has sued the HHS Office of Inspector General to compel it to release a range of Medicare Advantage health plan audits and other financial records.

#Payer

Notable Notes

Joint Commission, NAHQ join forces on quality training, education

The Joint Commission and the National Association for Healthcare Quality announced a strategic alliance to improve quality and safety workers’ training and standardize their education. The two organizations will remain separate and maintain their own accreditation and certification programs under the arrangement. However, the commission and NAHQ will collaborate on the development of micro-credentials tied to the association’s Healthcare Quality and Competency Framework.

#All

Matching patients to clinical trials with large language models

A new artificial intelligence algorithm developed by NIH researchers for a study released Monday could make it easier for underrepresented populations to enroll in cutting-edge research.

#All

Surgeons push for EMS vehicles to carry blood

The American College of Surgeons is urging more first responders to carry blood products in emergency vehicles to improve survival rates among patients with life-threatening bleeding.

#Provider

TAVR in the News

Medtronic using AI to identify more TAVR patients in need

Medtronic has launched new research into AI’s potential to identify patients with severe aortic stenosis and other worrying symptoms. The company hopes to overcome longstanding health disparities and reach individuals who may otherwise go untreated.

#Device, #Patient

Treating younger patients with TAVR increases risk of death

Treating patients younger than 65 with TAVR is associated with certain risks for heart teams to consider. Fortunately, researchers found, care teams appear to be choosing patients wisely.

#Device, #Patient, #Provider

Redo TAVR: The impact of implanting balloon-expandable valves in failed self-expanding valves

Researchers took a closer look at the effectiveness of redo TAVR, implanting Sapien 3 valves into a variety of explanted CoreValve and Evolut valves.

#Device, #Provider, #Patient

SAVR linked to higher 10-year survival rate than TAVR for low-risk patients

Surgical aortic valve replacement (SAVR) is associated with a much higher long-term survival rate than transcatheter aortic valve replacement (TAVR) when treating low-risk patients, according to new 10-year data published in IJC Heart & Vasculature.

#Device, #Provider, #Patient

How TAVR valve choice impacts outcomes when treating type 1 bicuspid AS

Self-expanding and balloon-expandable TAVR valves are associated with comparable success rates and one-year outcomes when treating type 1 bicuspid aortic stenosis. However, each valve type comes with its own advantages and disadvantages.

#Device, #Provider, #Patient

GLP-1s in the News

Semaglutide Eligibility Across All Current Indications for US Adults

A study in JAMA Network estimates that up to 136 million adult Americans may be eligible for Ozempic

#Drug, #Patient

Medicaid fuels US coverage of Novo, Lilly weight-loss drugs

U.S. government health plans account for the lion’s share of coverage for popular new weight-loss drugs, far beyond the reimbursement available from private employers and insurers, according to an analysis shared with Reuters. State Medicaid programs for low-income families are the single biggest source of coverage

#DRUG, #PATIENT

AHA 2024: First, a call for prevention. Then a spotlight on obesity drugs

This year’s American Heart Association conference spent a good chunk — predictably — on obesity drugs like tirzepatide and semaglutide, featuring groundbreaking trials on their impact in heart failure and cardiovascular risk reduction. Other key studies included intensive blood pressure management in type 2 diabetes, as well as novel approaches to treat transthyretin amyloidosis using CRISPR-based and RNA therapies.

#Patient, #Provider

Practice Trends

Why physicians are unhappy with employment

Physicians employed in hospital-owned practices are nearly three times more likely to report dissatisfaction than their peers in physician-owned practices, according to Bain & Company’s Frontline of Healthcare Survey, featured in an October blog post.

#Provider

AMA examines decade of change in physician practice ownership and organization

Physicians are flocking to employed models. From 2012 to 2022, the share of physicians who were self-employed dropped from 53% to 42%. The American Medical Association offers some tips on how independent practices can survive.

#Provider, #Hospital

Number of cardiologists jumping to hospital practice doubles: Study

Between 2008 and 2019, the share of cardiologists practicing in a hospital increased from 26% to 63%, according to a study published in the Journal of the American College of Cardiology.

#Provider, #Hospital, #Patient

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