Weekly Spotlight
This newsletter gests set for publication, hundreds of federal employees (excluding those who responded to the “Fork in the Road” email took the Trump administration up on an offer of severance or early retirement earlier this week) are waiting to see if they will be among those terminated by the end of the day.
Stories with a specific regulatory angle that is relevant to our top monitored topics will be included in our normal layout. For more Administration health coverage, skip to the bottom of the newsletter.
We now return to our regularly scheduled programming.
Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
OIG Report on Medicare Advantage: Questionable Use of Health Risk Assessments Continues To Drive Up Payments to Plans by Billions
Medicare Advantage (MA) companies receive higher risk-adjusted payments from the Centers for Medicare & Medicaid Services (CMS) for enrollees who are sicker, which helps to ensure that plans receive sufficient payment to cover more costly care and enrollees have continued access to MA plans. However, taxpayers fund billions of dollars in overpayments to MA companies each year based on unsupported diagnoses for MA enrollees. Unsupported diagnoses inflate risk-adjusted payments and drive improper payments in the MA program.
#Payer
Medicare Advantage insurers lobby Trump for relief
In comments on the Medicare Advantage and Part D policy proposed rule for 2026, health insurance trade associations call on the Centers for Medicare and Medicaid Services to make a slew of changes in the final rule, such as scrapping Medicare and Medicaid coverage of obesity drugs, extending a Medicare Advantage payment model the industry favors, and eliminating a health equity payment adjustment.
#Payer
Physicians want Medicare Advantage plans to stop auto-denying imaging services
The agency in December proposed updates to Medicare Advantage. This included forbidding plans from automatically denying coverage of basic benefits without first making an individual determination of medical necessity. CMS also is proposing to prohibit prior authorization criteria that “does not have any clinical benefit and, therefore, exists to reduce utilization of the item or service,” the American College of Nuclear Cardiology reported Feb. 2.
#Provider, #Patient, #Payer
Revenues, costs, and contribution margins of major inpatient cardiovascular procedures within the Medicare population
Coronary artery bypass grafts are the most lucrative cardiology procedures for hospitals nationwide, according to research from Philadelphia-based University of Pennsylvania’s Leonard Davis Institute of Health Economics that was published Dec. 3 in the American Heart Journal.
#Hospital, #Device
Center on Budget and Policy Priorities: Medicare Is Not “Bankrupt”
Claims by some policymakers that the Medicare program is nearing “bankruptcy” are highly misleading.[1] Although Medicare faces financing challenges, the program is not on the verge of bankruptcy or ceasing to operate. Such claims demonstrate misunderstanding (or misrepresentation) of Medicare’s finances.
#All
States Absorb Increases for Sicker Medicaid Enrollees After the Pandemic
States are absorbing substantial increases in healthcare costs for the poor, as they realize that the people remaining on Medicaid rolls after the COVID-19 pandemic are sicker than anticipated — and costlier
#Patient, #Payer
CMMI to scrap data collection on race, gender
The Center for Medicare and Medicaid Innovation will no longer collect data from its payment model participants on race, ethnicity, sexual orientation, gender identity and preferred language, the organization said Tuesday in an email sent to CMMI managers and obtained by POLITICO.
#ALL
Medicare removes sexual orientation, gender identity questions from enrollment forms
The U.S. agency that oversees Medicare is taking out questions on enrollment application forms that ask people about their sexual orientation and gender identity.
#ALL
Fact Sheet: President Donald J. Trump Establishes the Make America Healthy Again Commission
Chaired by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., the Commission is tasked with investigating and addressing the root causes of America’s escalating health crisis, with an initial focus on childhood chronic diseases.
#ALL
Food and Drug Administration (FDA)
RFK Jr.’s New Role Will Likely Change 6 Longstanding FDA Practices, Says National Expert
An expert on FDA compliance and regulations weighs in on this subject, and several others, to explain what could change in the near future under RFK’s direction. David Lennarz, President of Registrar Corp, has over 20 years of experience within the FDA compliance industry.
#All
Experts: FDA staff worried about unfinished work, keeping their jobs
Reports of impending layoffs, a buyout offer to federal workers, and a return to office mandate have put a damper on morale among staff at the US Food and Drug Administration (FDA). Experts and former FDA officials who spoke to Focus said that FDA staff are more concerned about meeting user fee review goals and completing essential tasks, though some are anxious about losing their jobs and have begun looking for opportunities in the private sector.
#ALL
Trump administration ordered to restore removed CDC and FDA websites
A federal judge on Tuesday ordered U.S. health agencies to restore websites that they abruptly took offline in response to an executive order by President Donald Trump telling them to scrub websites of “gender ideology extremism.” This follows a statement from leading physician groups on removal of data and guidance from federal websites
#ALL
Health and Human Services (HHS)
Pending US vaccine decisions as Kennedy takes top health job
Here are some pending regulatory decisions and meetings on vaccines coming up over the next few months:
#ALL
Hill Happenings
White House Forces Showdown Over Congress’s Power of the Purse
The confirmation of Russell T. Vought to lead the powerful White House budget office is likely to escalate the funding fights roiling Washington and the nation.
#All
CRS Report: Impacts of Federal Grants and Other Funds on State and Local Budgets
Together, state and local governments received more than $1 trillion in federal grants and other funds each fiscal year from FY2021 to FY2023 the most recent years for which final data is available. These funds play a role in helping these governments provide services such as education, health care, law enforcement, and public transit. This Insight explores the impacts of federal funds on state and local government budgets.
#All
House GOP eyes $880B in healthcare cuts
House Republicans released a budget blueprint on Wednesday that orders the primary healthcare committee to slash spending by $880 billion. The Budget Committee draft is the first step in an expedited process known as budget reconciliation that Republicans are using to extend tax cuts from President Donald Trump’s first term, as well as to fund border security, energy and defense initiatives.
#All
Notable Notes
As Trump pauses enforcement of an anti-bribery law, will pharma engage in bad behavior?
Between 2011 and 2020, 10 of the world’s largest pharmaceutical companies paid a combined $1.34 billion in fines to the U.S. government for bribing foreign officials in order to boost purchases of their medicines. The law that made it possible is the Foreign Corrupt Practices Act, which has been credited with making changes in long-standing industry business practices.
#Drug
This Is What Happens When HIV Drugs Are Stopped for Millions of People
PEPFAR has been one of the most successful foreign aid programs in history. HIV, which causes AIDS, is now manageable through the world, though there is still no cure. However, the Trump administration has put the brakes on foreign aid while alleging it’s wasteful, causing chaos in the system that for over 20 years has kept millions of people alive.
#ALL
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Lack of American involvement could lead to less effective flu vaccines, experts fear
#ALL
Cigna’s customer-centric strategy could ripple across the sector
The sweeping changes — at least on paper — to how Cigna interacts with its insurance members and Express Scripts pharmacy benefit manager customers could augur a new era for health insurance.
#ALL
Biotech is in a dark place
My recent conversations with folks in the biotech investing world can only be described as bleak. The market offers one beatdown after another. Sentiment is lousy and the bad mood is relentless, to the point where people are seriously wondering if a sector turnaround is ever possible.
#ALL
Cardiologists recommend AVR for asymptomatic severe AS—TAVR and surgery both viable options
A trio of leading voices in cardiology (Brian R. Lindman, MD, MSc; Eugene Braunwald, MD; Patricia A. Pellikka, MD) reviewed years of data while considering their proposal. The choice between TAVR and SAVR, they added, should be made on a case-by-case basis.
#PATIENT, #PROVIDER, #DEVICE
Opinion: There is no ‘amyloid cabal’ in Alzheimer’s research
STAT’s excerpt from Charles Piller’s book contains errors of fact, distortions, and misleading messages to our patients. But rather than refuting these point-by-point, I will address three faulty premises of his poorly supported case against the basic science and new treatments of Alzheimer’s disease.
#PATIENT, #DRUG
Health systems sharpen focus on outpatient safety
Efforts to improve quality and patient safety have historically focused on the inpatient setting. But as more care moves outside of hospital walls, health systems are beginning to craft structures and processes to better measure and improve safety in ambulatory settings.
#HOSPITAL, #PATIENT
Chartis: 2025 rural health state of the state Instability continues to threaten rural health safety net
Over the last year, 18 rural hospitals closed or converted to an operating model that excludes inpatient care. That brings the total since 2010 to 182. According to our newest analysis, 46% of rural hospitals have a negative operating margin, and 432 are vulnerable to closure.
#HOSPITAL
Final decision on the creation of a new cardiovascular board expected soon
U.S. cardiology groups have worked together to propose the creation of a new American Board of Cardiovascular Medicine for certifying cardiologists. Now, after many months of waiting, a final decision is expected by the end of February. The effort is spearheaded by the ACC in collaboration with the American Heart Association (AHA), Heart Failure Society of America (HFSA), Heart Rhythm Society (HRS), and the Society for Cardiovascular Angiography and Interventions (SCAI).
#PROVIDER
Interventional heart failure: An evolving cardiology subspecialty with a bright future
IHF cardiologists can come from a variety of backgrounds, but they all share the same goal: to ensure complex heart failure patients receive the best care possible.
#PROVIDER
ACC president details key advocacy efforts in cardiology
American College of Cardiology President Cathie Biga, MSN, says Medicare payment reform remains a top priority going forward. Site-neutral payments and improved access to PAD screening are two other issues close to the ACC’s heart.
#PROVIDER
Other Healthcare News from the Trump Administration
All the Executive Orders
All the executive orders explained. This page contains documents that have been published in the Federal Register.
Appropriations Vice Chair Patty Murray Publishes Fact Sheet
Week 3: Trump’s Funding Freeze Continues”
Judge finds Trump administration hasn’t fully followed his order to unfreeze federal spending
A federal judge found Monday that the Trump administration hasn’t fully followed his order to unfreeze federal spending and told the White House to release billions of dollars in funding. The Trump administration quickly appealed the ruling.
Terrifying’: Public Health Experts React to Senate’s Confirmation of RFK Jr. to Lead HHS
The Senate confirmed Robert F. Kennedy Jr., one of America’s most notorious vaccine skeptics, to run the country’s leading health agency, the U.S. Department of Health and Human Services (HHS), on Thursday, sparking outrage among public health experts who worry that Kennedy will harm public health and further erode trust in science and medicine.
Trump administration begins sweeping layoffs with probationary workers, warns of larger cuts to come
The Trump administration on Thursday intensified its sweeping efforts to shrink the size of the federal workforce, the nation’s largest employer, by ordering agencies to lay off nearly all probationary employees who had not yet gained civil service protection — potentially affecting hundreds of thousands of workers.
Opinion: A Crossroads for DEI: How Should Medical Institutions Respond?
Medical institutions across the U.S. — including associations, medical schools, and health systems — are facing a defining moment as political shifts threaten to reshape their approach to diversity, equity, and inclusion (DEI) initiatives
CMS
Why Is Elon Musk Investigating Medicare? What He’s Looking to Find
DOGE is looking to discover any possible fraud taking place within Medicare as well as investigate the program’s payment, contracting and technology systems in order to find any spending waste.
DOGE Turns Attention to the CMS and is Given Access to Key Systems Sparking Privacy Concerns
The Department of Government Efficiency (DOGE) staff has been provided access to key payment and contracting systems at the HHS Centers for Medicare and Medicaid Services (CMS) to look for opportunities for improving efficiency and to identify fraud and ineffective use of resources. Privacy advocates have expressed concern about the privacy risks from providing DOGE with access to CMS systems, as the agency provides health coverage to more than 160 million Americans through various programs including Medicare, Medicaid, and the Children’s Health Insurance Program.
CMS may evade Trump’s sweeping deregulation order
President Donald Trump’s government-wide directive to slash regulations doesn’t appear likely to hamstring day-to-day operations for companies that do business with programs such as Medicare and Medicaid. Trump’s executive order requires federal agencies to cut 10 regulations for each new one proposed. But its impact seems poised to be minimal at the Centers for Medicare and Medicaid Services, largely because most of the rules it issues are mandatory under statute.
NIH
Judge extends block on NIH research cuts nationwide: 4 notes
A federal judge in Boston has extended a temporary restraining order to block the Trump administration from implementing a new policy that would significantly cut federal grant funding for medical research projects nationwide
Trump’s NIH Pick Co-Founded New Journal
A new journal purports to improve the publishing process through open access and public peer review, but it was co-founded by researchers who challenged the U.S. response to COVID-19 — including President Trump’s pick to lead the NIH, Jay Bhattacharya, MD, PhD.
How NIH funding cuts could cost providers billions of dollars
Cutting federal grant funding will limit access to care and stymie research, providers warn.
Last week, the National Institutes of Health said it will cap the indirect cost payment rate for new and existing grants at 15%. Academic medical centers use that funding to cover the cost of administrative and infrastructure expenses tied to research.
Stanford, Harvard warn of Trump’s NIH funding cuts
The Trump administration’s NIH research funding cuts are its latest move against universities, which receive billions in federal support annually.
The view from overseas on tumult in U.S. science
President Trump’s new restrictions on science funding and research policies are raising concern about a potential exodus of U.S. scientists to other countries. Europe has long contended with its own brain drain, and has tried to reverse it in recent years by increasing research funding.
Top-ranking NIH official forced to retire under Trump administration
A top-ranking scientist at the National Institutes of Health, Dr. Lawrence Tabak, was forced to retire this week, multiple people familiar with the move say, marking the highest-profile departure of a health official under the Trump administration so far this year.
Second top NIH official, who oversaw awarding of research grants, departs abruptly
Michael Lauer, deputy director of the National Institutes of Health’s extramural research, will leave the agency at the end of the week.
Young researchers mobilize to protest Trump administration’s science policies
But resistance is starting to form. Unions representing fellows at the NIH and several universities are planning a protest at the headquarters of the Department of Health and Human Services next week. Simultaneously, a grassroots group of scientists is planning a protest in Washington, D.C., and state capitals around the country in March. Organizers for both protests said they were being pushed to action by political attacks that have directly affected their livelihoods and their ability to conduct research.
