Weekly Spotlight
As of this writing, the fate of the bill to fund the federal government remained in limbo, with a midnight deadline growing ever closer. What we do know is that the House passed its version of the Bill earlier this week and now stands in recess. The Senate Democratic caucus largely opposes the bill but at least three Democratic Senators, including Minority Leader, Chuck Schumer, have said they will vote for the spending measure. The bill famously does not include a promised “doc fix,” to reverse scheduled cuts to Medicare physician payment that technically went into effect at the beginning of this year.
Meanwhile, Oz is having his day on the Hill but Trump’s pick to lead the CDC saw his nomination yanked minutes before his scheduled nomination hearing because of lack of support from the Republican caucus over his controversial position on vaccinations.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
Dr. Oz: How His Millions Collide With Medicare
Dr. Mehmet Oz’s extensive financial ties to the health insurance industry and dietary supplement companies, raise concerns about potential conflicts of interest as he is nominated to oversee Medicare and Medicaid, particularly given his promotion of controversial private insurance plans and the vast financial interests he would need to manage. An examination of his health advice over the years, reveals that while some of his recommendations are based on solid scientific principles, many others lack sufficient evidence and may be influenced by financial ties to the products he promotes, raising concerns about his potential role in public health policy.
#All
Medicare Drug Price Negotiation Program Public Engagement Events
CMS is extending the registration deadline to March 19, 2025 for public engagement events for the second cycle of negotiations.
#Drug, #Patient
New Medicare telehealth data drops as industry waits on Congress
At the end of the month, policies that expanded Medicare coverage for telehealth during the pandemic will expire, unless Congress acts to extend them. Extending the policies for several years is a popular idea, but that proposal is likely contingent on getting an actual budget — rather than a stop-gap bill.
#Patient, #Provider
CMS deletes Medicare Advantage vision statement, signaling another shift from health equity
The Centers for Medicare & Medicaid Services (CMS) wiped away the agency’s stated intentions for the future of Medicare Advantage (MA), underlining new uncertainty for the future of health-related social needs, CMS Innovation Center models and the federal health program.
#Payer, #Patient
CMS pulls Biden-era Pay Models
The Center for Medicare and Medicaid Innovation said Wednesday that it is ending four payment models early, including two focused on investing in primary care.
#Provider, #Drug, #Patient
Food and Drug Administration (FDA)
FDA warns of scramble for workspaces and parking spots in Monday return to office
The FDA told staff this week it cannot guarantee workspaces or parking spots when they return to their offices en masse on Monday as required, raising concerns of further disruption at the agency
#All
Study reveals how often medical device makers report safety incidents late to FDA
In a new study in the BMJ, researchers analyzed the Food and Drug Administration database where manufactures report adverse events and found that a huge number of reports come in late.
#Device
Gilead data suggests once-yearly shot of PrEP drug blocks HIV infection
Last year, Gilead released data showing that an HIV drug, called lenacapavir, could provide virtually complete protection against infection with just a single injection every six months. The drug, now under regulatory review, was greeted as a breakthrough, the closest thing the field has ever had to a vaccine. On Tuesday, Gilead published early data suggesting a new formulation of the drug could be used to prevent infection with just a single shot every year.
#Drug
Opinion: A ‘conflict of interest-free’ FDA advisory committee policy is a terrible idea
Implementing a “conflict of interest-free” policy for FDA advisory committees would undermine the valuable transparency and rigorous scrutiny that currently enhance their decision-making processes.
#Drug, #Device
Health and Human Services (HHS)
Old laws, Supreme Court may stymie HHS plan to fast-track policy
Modern Healthcare explores how far HHS can go in its reinterpreation of the administrative procedures act to attempt to stymie public comment.
#All
National Cancer Institute Employees Can’t Publish Information on These Topics Without Special Approval
Employees at the National Cancer Institute (NCI) received internal guidance to flag for closer scrutiny a variety of communications that address 23 hot-button issues, including cancer moonshot, vaccines. Fluoride, and autism, among others. The Trump administration is also cancelling NIH studies about ways to improve vaccine trust and access,
#All
NCI-Designated Cancer Centers Worry About Their Future
NCI-designated cancer centers are facing uncertainty regarding their future due to cancellations and rescheduling of grant renewal site visits, which has raised concerns about funding and operational stability.
#All
Federal Agency Dedicated to Mental Illness and Addiction Faces Huge Cuts
The Substance Abuse and Mental Health Services Administration has already closed offices and could see staff numbers reduced by 50 percent.
#All
RFK Jr.’s ‘MAHA’ commission meets for the first time — behind closed doors
An array of federal government officials and “Make America Healthy Again” moms met Tuesday in what was the first convening of a new commission led by Health Secretary Robert F. Kennedy Jr.
#All
HHS braces for a reorganization
The Trump administration is readying to slash the Department of Health and Human Services workforce again, according to seven people familiar with the plans who were granted anonymity because of the sensitive nature of the changes.
#All
Trump administration plans to limit ACA enrollment period
The Trump administration is proposing regulations that would shorten the window for people to enroll in health insurance plans by a month.
#Patient
Hill Happenings
MedPAC estimates $84B in Medicare Advantage overpayments in 202
The Medicare Payment and Advisory Commission (MedPAC) estimates that the federal government will overpay $84 billion for Medicare Advantage enrollees in 2025 compared to fee-for-service plans, primarily due to factors like coding intensity and favorable selection.
#All
CDC’s reported study on vaccines and autism could test RFK Jr.’s pledges to a key senator
Reports of a new federal plan to study whether there’s a link between vaccines and autism could serve as an early test of the commitments Sen. Bill Cassidy (R-La.) said he received from Robert F. Kennedy Jr. in exchange for his support for RFK Jr.’s confirmation as Health and Human Services secretary.
#All
Sex, Drinking and Dementia: 25 Lawmakers Spill on What Congress Is Really Like
We interviewed Democrats and Republicans — on the record and anonymously — about life on Capitol Hill, what broke Congress and a whole lot more.
#All
CRS Clarifies Noncitizen Eligibility for Medicaid and CHIP
The Congressional Research Service is out with a three-page explainer on Medicaid and CHIP eligibility for people who are not U.S. citizens, noting that about 6 percent of Medicaid enrolled under age 65 are eligible non-citizens.
#All
GAO: Agencies and Congress Can Take Actions to Better Manage Improper Payments and Fraud Risks
Improper payments and fraud are long-standing and significant problems in the federal government. Since fiscal year 2003, cumulative improper payment estimates by executive branch agencies have totaled about $2.8 trillion. In fiscal year 2024, federal agencies estimated $162 billion in improper payments, representing 68 programs, a small subset of all federal programs. The fiscal year 2024 estimate is a decrease of about $74 billion from the prior year. The reduction in estimated improper payments is largely attributable to the completion or winding down of certain COVID-19 programs.
#All
Notable Notes
Opinion: Federal research instability risks postdoc careers, American leadership
Successful science and research efforts require a level of funding predictability. Over the past century, America has built an unparalleled engine of science and research innovation and accomplishment through a combination of public and private investment. In a research environment driven by intellectual curiosity, hard work, and rigorous principles, fear and instability are threats.
#All
Former NIH director Francis Collins, once beloved in Washington, now worries for his safety there
After decades of public service, earning respect along the way from politicians in both parties, Francis Collins, the former director of the National Institutes of Health, has found himself on the wrong side of President Trump’s “Make America Great Again” movement. In an exclusive interview, Collins tells STAT’s Anil Oza that he hired security at his home over concerns that he’s putting himself in danger by publicly criticizing the Trump administration’s policies toward the NIH. Collins came face to face with that reality on Friday, when he was confronted by an angry protester at the “Stand Up for Science Rally” in Washington, where he spoke out against the cuts being made by the administration at the NIH.
#All
TAVR in Africa linked to high success rate, but above-average risks
TAVR adoption in Africa has been relatively slow, but cardiologists throughout the continent have made considerable progress. New data does show that there is some work to be done before outcomes will rival what is seen in many other parts of the world.
#Device
TAVR linked to stronger valve performance than SAVR in new 5-year study
TAVR is associated with a significantly lower risk of bioprosthetic valve dysfunction than SAVR, according to new data presented at CRT 2025 and simultaneously published in JACC.
#Device, #Patient, #Provider
Self-expanding TAVR valves still linked to superior durability in patients with small annuli after 2 years
Researchers presented new two-year data from the SMART trial at CRT 2025 in Washington, D.C. Overall, self-expanding TAVR valves continue to show superior valve performance compared to balloon-expandable valves, and clinical outcomes remain comparable.
#Device, #Patient, #Provider
Cardiologists agree: Early TAVR or SAVR for asymptomatic severe AS limits strokes, hospitalizations
Two separate groups have published new research comparing early AVR with clinical surveillance for the treatment of asymptomatic severe aortic stenosis. Overall, the two groups found, early treatment was associated with multiple benefits—and no added risk of harm.
#Device, #Patient, #Provider
