Weekly Spotlight
The federal health policy landscape shifted dramatically this week as the Trump administration reshuffled HHS leadership, concentrating unusual authority in NIH Director Jay Bhattacharya while sidelining Secretary Robert F. Kennedy Jr.’s more aggressive agenda.
Bhattacharya was named acting CDC director after interim director Jim O’Neill was moved out of HHS, making the Stanford economist and Great Barrington Declaration co-author the temporary head of both the nation’s biomedical research enterprise and its disease surveillance agency. Public health experts immediately raised concerns about the consolidation of influence, particularly given Bhattacharya’s vocal skepticism of mainstream public health approaches during the pandemic.
The CDC move came alongside a broader HHS reorganization. Deputy Secretary O’Neill and General Counsel Mike Stuart were shifted out of health agencies, while a new team of policy officials has been elevated to steer the department toward politically popular initiatives around healthy food and drug pricing ahead of the 2026 midterms. The White House is reportedly recalibrating away from Kennedy’s more divisive positions, believing the department pushed the health industry too far.
Meanwhile, the agencies Bhattacharya oversees face deepening institutional challenges. Sixteen of NIH’s 27 institutes and centers currently lack permanent directors — 14 are led by acting directors and two more are in transition. Former officials have questioned the hiring process after at least one appointment appeared to involve political connections, and Bhattacharya has signaled plans to redistribute funding geographically rather than purely on merit.
The leadership vacuum has prompted states to begin building their own research infrastructure. Massachusetts’s DRIVE initiative would provide $400 million to universities, and New York is pursuing a $6 billion Empire Biomedical Research Institute. But researchers warn that state funding cannot replace federal support and that promoting alternatives could weaken arguments for NIH’s central role.
Congressional oversight has also stalled. Senate HELP Committee Chairman Bill Cassidy invited Kennedy to testify five months ago, but no hearing date has been set. Kennedy has broken multiple promises made to secure Cassidy’s confirmation vote, including firing all 17 ACIP members and revising the CDC website on vaccines and autism. The Advisory Committee on Immunization Practices has postponed its February meeting for undisclosed reasons, adding to concerns about the functional paralysis of federal health agencies.
The stakes extend beyond bureaucratic reshuffling. With 55% of Medicare beneficiaries in Advantage plans, Medicaid work requirements looming, and FDA making consequential decisions on drug and vaccine approvals, the question of who holds authority at HHS — and whether they have the expertise to exercise it — has never been more consequential.
Tags: #ALL
Centers for Medicare and Medicaid Services (CMS)
CMS Proposes Expanding Catastrophic Plan Access on ACA Exchanges
The Trump administration proposed a rule to expand access to catastrophic-level health plans on the ACA exchanges, positioning the move as a response to soaring marketplace premiums. The proposal would loosen eligibility for high-deductible plans beyond the current age and income restrictions that have limited enrollment since the exchanges launched. Industry stakeholders are watching closely for implications on risk pool stability and the broader exchange market.
Source(s):
Inside CMS’s big bet on catastrophic ACA plans
Inside CMS’s big bet on catastrophic ACA plans
Tags: #PAYER #PATIENT
Trump Required Hospitals To Post Their Prices for Patients. Mostly It’s the Industry Using the Data.
Despite two presidential administrations pushing hospital price transparency rules since 2021, there is no evidence patients are using the posted data to shop for care, according to Yale health economist Zack Cooper. Instead, insurers and health systems use the data as leverage in contract negotiations. CMS fined only 27 hospitals for noncompliance between June 2022 and May 2025, and while the 2026 funding bill increased fines and data-detail requirements, researchers note patients face structural barriers including variable charges, complex billing codes, and physician-directed referrals that bypass price comparison.
Source(s): Trump Required Hospitals To Post Their Prices for Patients. Mostly It’s the Industry Using the Data.
Tags: #HOSPITAL #PAYER #PROVIDER
The company Tying Its Success to CMS’ TEAM Model
Rainfall Health announced a $15 million Series A funding round to support hospitals participating in CMS’s mandatory Transforming Episode Accountability Model (TEAM), which went live January 1. TEAM provides bundled payments for five common procedures affecting more than 700 hospitals and putting roughly 20% of their Medicare revenue at risk. The startup’s platform uses AI for compliance and case management, and it will only get paid if hospitals receive TEAM incentive payments.
Source(s): The company tying its success to CMS’ TEAM model
Tags: #HOSPITAL #PROVIDER
When It Comes to Health Insurance, Federal Dollars Support More Than ACA Plans
A KFF Health News analysis highlights that the employer-sponsored insurance tax exclusion — the single largest exclusion in the federal budget at an estimated $451 billion this fiscal year — dwarfs the roughly $35 billion annual cost of extending enhanced ACA subsidies. The tax break allows employers to deduct health coverage costs while workers avoid income and payroll taxes on the benefit’s value, with the largest savings flowing to those with the most expensive plans and highest tax brackets.
Source(s): When It Comes to Health Insurance, Federal Dollars Support More Than ACA Plans
Tags: #PAYER #PATIENT #PROVIDER
Medicare Advantage Roundup
Several developments this week highlighted the growing tensions in the Medicare Advantage market, from slowing enrollment growth to provider pushback on access restrictions.
- Medicare Advantage growth dwindles for a second straight year
- UnitedHealth Group was the most profitable payer in a difficult 2025 for the industry
- United Healthcare Reins in Access to Specialty Care in Medicare Advantage
- Medicare Advantage’s ‘sunk-cost’ problem
Tags: #PAYER #HOSPITAL #PROVIDER
Medicaid Roundup
This week brought new analysis on Medicaid work requirements and data quality challenges that could complicate program oversight.
- New Medicaid work rules likely to hit middle-aged adults hard
- What Newly-Released Medicaid Data Do and Don’t Tell Us
Tags: #PATIENT #PAYER #PROVIDER
CMS Taps New Deputy Chief of Staff, Communications
Christopher Krepich has been named CMS’s deputy chief of staff for communications, according to a February 22 LinkedIn post. Krepich previously served as CMS’s office of communications director and as senior communications advisor for the House Energy and Commerce Committee.
Source(s): CMS taps new deputy chief of staff, communications
Tags: #ALL
AI Emerges as the Next Frontier for Prior Authorization Reform
The digital health sector’s ambient AI focus is shifting from clinical documentation to prior authorization, with companies like Abridge and Cohere Health pursuing partnership-based approaches to reduce the administrative burden on providers and payers. A MedCity News op-ed argues that CMS’s new prior authorization rule underscores the urgency, noting that payers currently operate at machine speed while providers operate at human speed — and that regulated AI, not just regulatory reform alone, is necessary to close the gap and prevent patients from bearing the cost of delayed care.
Source(s):
AI companies are leaning on partnerships for prior authorization
Prior Authorization Is Broken. CMS’s New Rule Shows Why Regulated AI Is the Way Out
Tags: #PROVIDER #PAYER
Food and Drug Administration (FDA)
Vaccine Policy in Turmoil: FDA Reverses Moderna Decision as ACIP Meeting Postponed
The Advisory Committee on Immunization Practices postponed its February meeting for undisclosed reasons, even as a federal lawsuit seeks to declare the Kennedy-appointed panel illegitimate — the latest sign of functional paralysis in U.S. vaccine infrastructure. The postponement followed the FDA’s reversal of its refusal to review Moderna’s mRNA flu vaccine application, a decision originally made personally by CBER head Vinay Prasad over career scientists’ objections. Under the revised approach, the FDA will consider full approval for adults 50–64 and accelerated approval for those 65 and older, with an August 5 target date. But the broader chilling effect continues: Moderna’s CEO announced the company will no longer invest in new Phase 3 infectious disease trials in the U.S., shelving vaccines for Epstein-Barr, herpes, and shingles, while other manufacturers are curtailing research and cutting jobs under the administration’s hostile stance toward immunizations.
Source(s):
Amid CDC upheaval, key vaccine panel won’t convene February meeting
ACIP meeting postponed, for reasons that are unclear
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
FDA reverses course and will review Moderna’s mRNA-based flu shot
STAT+: FDA reverses course, agrees to review Moderna’s flu vaccine
STAT+: The FDA’s Moderna pirouette is one more sign of chaos at the agency
Opinion: I was a Moderna exec when the Covid vaccine rolled out. That spirit of possibility is no more
Vaccine Makers Curtail Research and Cut Jobs
Tags: #DRUG #PATIENT #PROVIDER
Statin Labeling Should Be Revised With Updated Warnings, Meta-Analysis Confirms
A meta-analysis of data from more than 123,000 patients found that dozens of adverse complications currently listed on statin labels can safely be removed. The findings support revising statin labeling to more accurately reflect the drug class’s risk profile, potentially reducing patient hesitancy driven by overstated side effect warnings.
Source(s): Statin labeling should be revised with updated warnings, meta-analysis confirms
Tags: #DRUG #PROVIDER
FDA Shifts to Single-Study Default for New Drug Approvals
FDA Commissioner Marty Makary and CBER head Vinay Prasad announced in a New England Journal of Medicine article that the FDA’s default position will now be to require one adequate study for new drug approvals, replacing the longstanding two-study standard dating to the 1960s. Roughly 60% of first-of-a-kind drugs approved in recent years were already cleared on single studies, but the change will mainly impact drugs for common diseases that previously required two trials. Former FDA drug center director Janet Woodcock called the scientific reasoning sound but said implementation will be critical, noting the industry is “already baffled” by the agency’s inconsistent approach — particularly the contrast with Prasad’s restrictive recent actions on vaccines and gene therapies.
Source(s):
FDA will drop two-study requirement for new drug approvals, aiming to speed access
FDA Shifts to Single-Study Default for New Drug Approvals
Tags: #DRUG
STAT+: Pharma lobbyists Focus On A Surprising New Target: the FDA
Pharmaceutical lobbyists are increasingly targeting the FDA for influence, a shift from the agency’s traditional insulation from political lobbying, according to 10 sources including lobbyists, advisers, FDA officials, and an executive. The Trump administration’s injection of political priorities into FDA decision-making has opened new avenues, with lobbyists telling STAT they believe approval odds increase if a decision can be framed as a win for the administration. The trend runs counter to HHS Secretary Kennedy’s stated goal of rooting out industry influence from the agency.
Source(s): STAT+: Pharma lobbyists focus on a surprising new target: the FDA
Tags: #DRUG
MedTech Roundup
This week saw notable developments in medical devices and diagnostic technology, from robotic surgery milestones to novel approaches in cardiac care.
- AI-powered MRI evaluations predict STEMI outcomes better than existing risk scores
- Stryker aims for ASCs and reluctant surgeons with its new MakoRPS robotic system
- Cardiologist develops new heart device that uses gel to reduce stroke risk in AFib patients
- Medtronic completed the first U.S. case with its Hugo robotic surgery system at the Cleveland Clinic, while reporting Q3 FY2026 cardiovascular revenue of $3.46 billion (up 14% YoY), driven by cardiac ablation solutions revenue growing more than 80% worldwide on pulsed field ablation adoption. Sources: Medtronic completes first Hugo case in the US, Medtronic reports rising sales for cardiovascular devices—PFA tech leads the way
Tags: #DEVICE #PROVIDER
Department of Health and Human Services (HHS)
NIH and CDC Leadership in Flux as States Build Research Alternatives
NIH Director Jay Bhattacharya has been named acting CDC director, becoming the agency’s third leader of Trump’s second term and concentrating unusual authority over both the nation’s biomedical research and disease surveillance agencies. The move is part of a broader HHS leadership reshuffle that elevated a new policy team to steer the department toward politically popular initiatives ahead of the 2026 midterms. Meanwhile, 16 of NIH’s 27 institutes and centers lack permanent directors, and Bhattacharya has signaled plans to redistribute funding geographically rather than purely on merit. States including Massachusetts ($400 million DRIVE initiative) and New York ($6 billion Empire Biomedical Research Institute) are developing their own science funding as federal research dollars grow uncertain, though researchers warn state funding cannot replace NIH’s central role.
Source(s):
N.I.H. Director Will Temporarily Run C.D.C. in Leadership Shake-Up
Trump Team Taps New Acting CDC Director
STAT+: 5 key people to watch at HHS after Trump’s shake-up
With federal research funding uncertain, states debate new science initiatives
16 NIH Institutes Have No Permanent Directors
Bhattacharya’s growing power in Trump’s HHS worries health experts
Tags: #ALL
High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed
A new GAO report found that HHS procedures for reviewing gain-of-function research — studies that modify pathogens with pandemic potential — generally include risk identification and assessment but lack public transparency. GAO noted there is no broad scientific consensus on the extent to which such research has directly led to vaccine or therapeutic development, while there is wide agreement on biosafety and biosecurity risks. The report recommends HHS publicly share more information about how research risk is assessed and mitigated.
Source(s): High Risk Research: HHS Should Publicly Share More Information on How Risk Is Assessed
Tags: #ALL
Public Health Preparedness: Improved Coordination Needed for HHS’s Emergency Preparedness Programs
A new GAO report finds that HHS needs improved coordination across its two main emergency preparedness grant programs. HHS awarded almost $900 million in fiscal year 2024 to states and jurisdictions through these programs, but GAO identified overlap and coordination gaps that could undermine readiness for public health emergencies. The report recommends structural changes to better align the programs’ planning, assessment, and reporting requirements.
Source(s): Public Health Preparedness: Improved Coordination Needed for HHS’s Emergency Preparedness Programs
Tags: #HOSPITAL #PROVIDER
Heard on the Hill
Five months After Sen. Bill Cassidy Asked RFK Jr. to Testify, It Still Hasn’t Happened
Senate HELP Committee Chairman Bill Cassidy (R-LA) invited HHS Secretary Robert F. Kennedy Jr. to testify in September 2024, but no hearing date has been set five months later. Kennedy has broken multiple promises made to secure Cassidy’s confirmation vote, including firing all 17 ACIP members and revising the CDC website on vaccines and autism. Cassidy now faces a Trump-endorsed primary challenger, Rep. Julia Letlow, backed by $1 million from Kennedy ally Tony Lyons’s MAHA PAC.
Source(s): Five months after Sen. Bill Cassidy asked RFK Jr. to testify, it still hasn’t happened
Tags: #PROVIDER #PATIENT
The Republicans Made Peace With Science
Congress rejected the Trump administration’s proposed 40% cut to NIH, instead increasing the agency’s budget by roughly $415 million to $48.7 billion in the 2026 funding bill. NASA faced a 1.6% cut versus the 24% proposed, and NSF dropped 3.4% instead of 57%. Research by Alexander Furnas and colleagues published in Science found that science funding has historically been higher under Republican-controlled Houses and presidencies.
Source(s): The Republicans Made Peace With Science
Tags: #DRUG #DEVICE
Senate HELP Committee Chair Pitches Proposals for FDA Reform
Senate HELP Committee Chairman Bill Cassidy released an 18-page report outlining proposed FDA reforms, including expanding novel clinical trial designs, broadening accelerated approval beyond oncology, modernizing the framework for rare disease and personalized medicines, and increasing consistency in AI regulation. The report also calls for legislative action to codify biosimilar interchangeability standards and address barriers to generic drug competition, citing China’s R&D ascent as evidence that U.S. regulatory burdens are driving drug sponsors overseas.
Source(s): Senate HELP Committee chair pitches proposals for FDA reform
Tags: #DRUG #DEVICE #PROVIDER
How Congress Made It Easier To Cut Hospital Outpatient Pay
A new law signed by President Trump requires health systems to obtain unique National Provider Identifiers for their outpatient departments by 2028, giving CMS and private insurers detailed data to support future site-neutral payment policies. Although the law does not modify Medicare payments directly, it enables easier comparisons between hospital outpatient departments and independent physician offices. Congressional leaders including Sen. John Kennedy (R-La.) are already pushing site-neutral legislation, with CBO projecting $157 billion in savings over 10 years.
Source(s): How Congress made it easier to cut hospital outpatient pay
Tags: #HOSPITAL #PAYER #PROVIDER
No Surprises Act Shows Mixed Results as Arbitration System Draws Scrutiny
A GAO analysis found that the percentage of in-network claims increased for three of four specialty areas most affected by the No Surprises Act — emergency medicine, radiology, anesthesiology, and air ambulance — after implementation, reversing a pre-act decline in emergency medicine in-network rates. However, providers and insurers are accusing each other of gaming the independent dispute resolution process, sometimes pulling patients back into billing disputes the law was designed to prevent. The arbitration system has created friction points where patients may face unexpected collection actions or balance billing in edge cases the law did not clearly address.
Source(s):
Private Health Insurance: Provider Participation and Payments for Selected Services
No Surprises Act arbitration drags patients into billing disputes
Tags: #PATIENT #PROVIDER #PAYER
Notable Notes
TAVR Expansion Raises Durability Questions as Evolut Trial Shows Reintervention Divergence
A six-year update to the Evolut Low Risk trial found that TAVR was associated with a higher risk of reintervention compared to surgical aortic valve replacement in low-risk patients — the first time the trial has shown a meaningful divergence favoring SAVR after five years of comparable outcomes. The finding comes as separate registry data show a significant shift toward TAVR over SAVR in younger patients with severe aortic stenosis, even as many experts continue to recommend surgery for patients under 65. The accelerating trend raises questions about long-term device durability and appropriate patient selection as TAVR use expands well beyond its original high-risk population.
Source(s):
TAVR linked to higher reintervention rate than SAVR in Evolut Low Risk trial update
Registry data point to ‘striking shift’ in treatment decisions after FDA approved low-risk TAVR
Tags: #DEVICE #PROVIDER
GLP-1 Market Update: Novo’s CagriSema Fails Head-to-Head Against Lilly’s Zepbound as Lilly Expands Self-Pay Access
Novo Nordisk’s next-generation obesity drug CagriSema failed to demonstrate non-inferiority against Eli Lilly’s tirzepatide (Zepbound) in the REDEFINE 4 trial, with patients losing 20.2% of body weight over 84 weeks versus 23.6% for tirzepatide. Novo shares fell more than 12%, adding to a stock decline of more than 50% over the past year as Wegovy loses U.S. market share to Lilly. Separately, Lilly is making multidose Zepbound KwikPens available through its direct-to-consumer self-pay platform after receiving the FDA label expansion.
Source(s):
STAT+: Novo’s next-gen obesity drug stumbles in Lilly comparison study
Novo’s CagriSema loses phase 3 battle with Lilly’s Zepbound, knocking 15% off share price
Lilly adds multidose Zepbound pens to self-pay menu after FDA nod
Tags: #DRUG #PATIENT
Patient News Roundup
This week brought several developments affecting patients directly, from diagnostic breakthroughs to clinical trial participation and treatment access debates.
- Study finds blood test can predict age of Alzheimer’s onset
- ViVE 2026: How to boost the number of women participating in clinical trials
- Death after PCI seen in just 0.5% of patients—heart attack, cardiac arrest most common causes
- Grail’s Galleri multi-cancer early detection blood test failed its primary endpoint in the NHS-Galleri trial of 142,000 participants, a major setback for the MCED testing field. Shares lost roughly half their value. Sources: Grail’s Galleri Multi-Cancer Blood Test Fails Key NHS Clinical Trial, A Cancer Detection Test Fails in Major Study, Grail’s multi-cancer early detection test misses study goal
- HHS Secretary Kennedy has criticized broadening use of anxiety medications, but doctors and researchers say the MAHA movement is misrepresenting treatments proved safe and effective for chronic anxiety. Sources: As More Americans Embrace Anxiety Treatment, MAHA Derides Medications
Tags: #PATIENT #DRUG #PROVIDER
Healthcare Real Estate Report Confirms Trend Toward Outpatient Care
A Colliers/Revista report shows outpatient healthcare real estate occupancy exceeding 92% in many major markets, with development starts increasing after a multiyear slowdown. Health systems are prioritizing adaptable building design for multispecialty consolidation, and nearly 100 new buyers entered the medical office market in 2025. The trend aligns with CMS’s site-neutral policy and recent moves by systems like Ascension toward ambulatory care models.
Source(s): Healthcare real estate report confirms trend toward outpatient care
Tags: #HOSPITAL #PROVIDER
Rising healthcare costs strain health system margins
Median health system operating margins dipped from 1.5% in November to 1.3% in December 2025, reversing four months of improvement. Supply expenses jumped 12.3% year-over-year while drug expenses rose 6.1% and labor costs increased 4.2%. Vizient projects that technology and facility costs will overtake pharmacy spend in anticipated cost growth for the first time in over a decade, driven by investments in robotic platforms and pulsed field ablation systems.
Source(s): Rising healthcare costs strain health system margins
Tags: #HOSPITAL #PAYER
Meet the ‘Change Agent’ Trying to Shake Up the AMA
John Whyte, MD, MPH, who became the AMA’s executive vice president and CEO in July 2025 replacing James Madara, discussed his priorities and early experience in the role in a MedPage Today interview. Whyte has positioned himself as a change agent for the organization, signaling a shift in how the AMA engages on policy and physician advocacy.
Source(s): Meet the ‘Change Agent’ Trying to Shake Up the AMA
Tags: #PROVIDER
Opinion: No one in Health Care Should Be Called A ‘Provider’
The American College of Physicians published an ethics policy paper in the Annals of Internal Medicine arguing that the term “provider” reduces the physician-patient relationship to a commercial transaction and should be retired in favor of specific professional titles. ACP co-authors frame the argument as one of ethics and patient care rather than professional hierarchy or turf.
Source(s): Opinion: No one in health care should be called a ‘provider’
Tags: #PROVIDER