Weekly Spotlight
The White House Reaches for NIH’s Grant Decisions
The White House is drafting an executive order that would create an external committee with power to veto National Institutes of Health grants that do not align with administration priorities, The New York Times reports. The order would extend political control over billions of dollars in research funding, and the draft was discussed at a contentious White House meeting Friday.
The courts are already weighing how far that control can reach. Researchers represented by the ACLU and Protect Democracy filed a class action Sept. 16 alleging NIH screens grant applications and active grants against a list of 235 forbidden keywords, including equity, gender and climate change, in violation of the First Amendment. The plaintiffs, 13 named and four anonymous, seek reinstatement of terminated grants, and STAT notes a ruling in their favor would reach every researcher affected by the term searches.
At the same time NIH is widening who can receive its money. The agency opened its research facilities funding, previously limited to universities and nonprofits, to local governments, federal agencies, community organizations and for-profit businesses STAT reports.
The infrastructure around federal research is also exposed. Senate Democratic appropriators say HHS plans to let tens of millions of dollars appropriated for the Agency for Healthcare Research and Quality expire Sept. 30, stranding its support for the U.S. Preventive Services Task Force, according to Inside Health Policy. Against that backdrop, an opinion piece in STAT argues NIH’s budget should double to $100 billion a year.
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Centers for Medicare and Medicaid Services (CMS)
Records Show a Rushed WISeR Launch as CMS Holds It Up as a Model
More than a thousand pages of records obtained by the Electronic Frontier Foundation through a Freedom of Information Act lawsuit show CMS launched its WISeR AI prior authorization pilot in January 2026 in six states over a vendor’s warning that a working product by launch was unrealistic. The records show prior authorization responses delayed beyond 72 hours, one request unanswered for 83 days, and two vendors denying 5,944 requests in the first three months. The CMS Innovation Center’s director has said WISeR should serve as a model for other lines of business, and on Sept. 16 HHS deputy secretary nominee Chris Klomp defended it against Senate Democrats who want it canceled, promising vendor-level accounting.
- Medicare’s AI Prior Authorization Pilot Was Rushed, New Documents Reveal
- New Records Reveal Problems with Medicare’s AI Prior Authorization Experiment
- CMMI head: WISeR should serve as model
- Klomp Defends WISeR As Dems Demand It Be Scrapped, Teases Vender-Specific Data
Tags: #PROVIDER #PAYER #PATIENT
Medicaid Roundup: Financing Cuts, Eligibility Rules and a 50-State Drug Deal
Pressure on state Medicaid programs arrived from three directions this week: federal financing cuts moving toward state budgets, the rules that will decide who keeps coverage under work requirements, and a drug-pricing model every state has now joined. KFF finds state revenue grew 2% in FY 2026 and fell in 20 states, with Medicaid at 31% of total state spending, as state-directed payment cuts begin with an $8.7 billion reduction in January 2028. CMS released roughly $12 billion in supplemental Medicaid funding for Texas hospitals that it had frozen Sept. 1, and President Trump announced Sept. 18 that all 50 states will join the Medicaid GENEROUS model, though experts say its claimed savings cannot be checked.
- SDP cuts will start with $8.7 billion in 2028: study
- Trump administration affordability push features SDP cuts
- CMS restores $12B in frozen supplemental Medicaid funds
- State Fiscal Conditions: Context on Medicaid Budgets for FY 2027
- A Closer Look at the Rural Health Transformation Program
- CMS Outlines Behavioral Health Codes For Medically Frail Exemption, Advocates Worry About Conservative Code Lists
- CMS Reviews Comments On Work Req Interim Final Rule
- Medicaid: Improved Oversight Needed of State Eligibility Error Corrective Action Plans
- Trump Announces All 50 States Are Joining Medicaid Drug Pricing Model
Tags: #PATIENT #PAYER #HOSPITAL
Medicare Expands ACCESS to Heart Failure and COPD
CMS will add heart failure, COPD, substance use disorder and tobacco cessation tracks to its ACCESS Model in spring 2027, paying participants monthly for managing chronic conditions with digital tools against measured outcomes. More than 160 organizations have enrolled, among them Dexcom, Whoop, Headspace and Welldoc. Agency officials are also signaling interest in cross-payer alignment and a possible Medicaid expansion of the 10-year model.
CMS STAT (subscription) Fierce Healthcare MedTech Dive
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Medicare Advantage Under Strain
Medicare Advantage now covers more than half of eligible beneficiaries, and for a growing number of health systems participation has become a losing proposition either way: stay in and absorb losses, or exit and cede enrollment in Medicare’s fastest-growing segment. Some systems are dropping MA contracts as denial rates rise, while CMS told insurers it may let MA plans expand their service areas midyear when they acquire a struggling competitor.
- The Medicare Advantage ‘quagmire’ facing hospitals
- As MA Denial Rates Rise, Hospitals Are Betting on Traditional Medicare Instead
- CMS Policy To Ease Medicare Advantage Insurer Acquisitions
- Medicare Advantage is making billions. Taxpayers deserve to know what they are buying
Tags: #PAYER #HOSPITAL
SCAI Reads the Final TAVR Coverage Decision
The Society for Cardiovascular Angiography and Interventions’ analysis of the final transcatheter aortic valve replacement National Coverage Determination emphasizes that the memo eliminates hospital procedural volume requirements and permits single-operator procedures, with operators drawn from any combination of interventional cardiologists and cardiac surgeons. SCAI says it will work with CMS on implementation and take part in the separate coverage analysis for TAVR in aortic regurgitation.
Tags: #DEVICE #PROVIDER #HOSPITAL
Also in CMS
Documents obtained through Freedom of Information Act lawsuits show the administration’s confidential drug-pricing agreements with Pfizer and Eli Lilly include undisclosed terms, among them inducements to raise prices overseas and promised protection from tariffs, and a Lancet modeling study finds the proposed Medicare most-favored-nation policies could raise prices and slow drug launches worldwide. Network Health went live early with Epic’s prior authorization API ahead of CMS’s Jan. 1, 2027 interoperability deadline. A long-term care pharmacy trade group wants CMS to use an upcoming request for information to set separate contracting guidance for LTC pharmacies, including reimbursement rates and network adequacy standards.
Tags: #DRUG #PAYER #PROVIDER
Food and Drug Administration (FDA)
FDA Opens Its Expedited IND Pilot
FDA began accepting applications Sept. 15 for its Expedited Investigational New Drug Pilot, run under HHS’s Operation TrialBlazer, which will select up to 10 qualified research institutions to work with drug sponsors for rolling review of application components. The aim is to shorten a U.S. path to first-in-human trials that can take up to two years, against under 70 days in Australia, and applications close Oct. 30, 2026. The agency downplayed concerns from some academic medical centers that the pairing model could create conflicts of interest.
FDA BioPharma Dive STAT (subscription) Inside Health Policy
Tags: #DRUG
FDA’s Rebuild Runs Into the Cuts That Made It Necessary
FDA is trying to hire more than 2,000 workers after the April 2025 DOGE cuts eliminated 3,500 positions, but the push is delayed because those same cuts left the agency’s centralized hiring center short-staffed. The Center for Devices and Radiological Health, which held relatively stable through the turbulence, now faces its own test as hiring ramps back up.
STAT (subscription) Medtech Insight (subscription)
Tags: #DRUG #DEVICE
FDA’s Evidence Commitments Under Scrutiny
Three items this week bear on how much evidence stands behind FDA decisions. A KFF Health News investigation found drugs and devices approved years ago still have not completed FDA-mandated postmarket safety studies, and patient advocacy groups say the industry-negotiated PDUFA VIII draft weights approval speed over review quality. FDA’s own analysis of first-cycle complete response rates from FY2008 through FY2024 gives that debate a benchmark.
- The Drugs And Devices Have Been On The Market For Years. But FDA-Ordered Studies Still Aren’t Done
- Advocacy Groups Worry Industry-Backed PDUFA VIII Draft Prioritizes Approval Speed Over Quality
- Report: First-Cycle Complete Response Rates for CDER NDA and BLA Applications: A Longitudinal Analysis, FY 2008–2024
Tags: #DRUG #DEVICE #PATIENT
Also in FDA
A new FDA rare disease strategic plan carries forward regulatory goals backed by former commissioner Marty Makary, and Karim Mikhail, now permanent director of the Center for Biologics Evaluation and Research, is putting rare disease access and patient engagement at the center of his agenda. CDRH launched a Regulatory Reliance Portal for regulatory authorities building medical device reliance programs, and issued draft guidance on an electronic submission template for premarket approval applications, with comments due Nov. 17.
Tags: #DRUG #DEVICE
Department of Health and Human Services (HHS)
Vaccine Policy: Children Wait for Covid Shots as Kennedy Promises More Changes
Three weeks after FDA approved updated Covid vaccines, about half of U.S. children still cannot get them because doses have not been made available through the Vaccines for Children program, which supplies free vaccines to eligible children, including those who are uninsured or underinsured. Health and Human Services Secretary Robert F. Kennedy Jr. told Children’s Health Defense on Sept. 17 that the department will keep pursuing major vaccine policy changes and continue studying alleged vaccine injuries.
- Covid Vaccines Delayed For Half Of U.S. Children
- RFK Jr. Promises More Policy Changes, Vaccine Injury Focus In Speech To CHD
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Administration Sets Out How It Will Enforce Mental Health Parity
The Labor Department issued guidance on how the administration will enforce mental health parity requirements, focusing on areas including pretreatment claims reviews and insurer network adequacy, with a proposed regulation expected by December. The administration has declined to enforce a Biden-era rule that required plans to regularly evaluate their provider networks, payment rates and other factors.
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Also in HHS
Secretary Kennedy named eight new members to the U.S. Preventive Services Task Force, including specialists and a health care finance expert as chair, raising the question of whether cost-effectiveness will enter a panel that has excluded it. ARPA-H launched an autism research project that will collect personal health information from people with autism. New OPTN rules for donation after circulatory death take effect Nov. 18. The administration is also putting federal resources behind AI agents that diagnose patients and prescribe treatment, a push some officials worry is outrunning the evidence.
Tags: #PATIENT #PROVIDER
Heard on the Hill
Ways and Means Advances a Bill Changing How MedPAC Compares Medicare Advantage
Ways and Means Republicans advanced the Apples to Apples Comparison Act on a party-line vote Sept. 16, requiring CMS to publish more data for MedPAC’s comparisons of Medicare Advantage and fee-for-service spending. MA plans backed the bill, and Democrats say it is designed to make plans look better. MedPAC currently estimates Medicare pays 14% more per MA enrollee than traditional Medicare would cost, or $76 billion in total.
STAT (subscription) Inside Health Policy
Tags: #PAYER
No Surprises Act: Employers and Think Tanks Press for a Rewrite
Pressure to rewrite the No Surprises Act’s arbitration process widened beyond providers and insurers this week. Large employers told Congress arbitration is driving up premiums, Paragon Health Institute proposed eliminating federal arbitration for elective care, and a Health Affairs analysis put the process’s four-year cost at $22.4 billion, a figure provider groups dispute. HHS certified a 17th arbitration entity as dispute volume outstrips capacity, and Congress has no consensus on a fix.
- Industry titans’ warning to Congress: Do what we say or health insurance premiums go up
- Paragon Pitches Two-Track Framework To Reform NSA Arbitration
- Mounting calls for surprise billing reform face a divided Congress
- 5 No Surprises Act updates
- HHS adds new IDR entity as surprise billing disputes surge
- Why HaloMD became a target — and what its top lobbyist says critics get wrong
- CMS Urges No Surprises Act Arbitration Parties To Register On IDR Gateway
Tags: #PAYER #PROVIDER #HOSPITAL
Physician Pay Reform Gains Momentum at E&C Health Hearing
The bipartisan doctors caucuses’ Medicare physician pay reform bill drew widespread support from lawmakers and witnesses at the House Energy and Commerce health subcommittee’s Sept. 15 hearing, building momentum as committee leaders are pressed to include it in a markup. The same hearing took up rural hospitals’ capacity to meet cybersecurity demands.
Inside Health Policy Becker’s Hospital Review
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Senate Health Nominations: Klomp Testifies, Overton Is Next
HHS deputy secretary nominee Chris Klomp faced two days of questioning before the Senate Finance and HELP committees, where senators pressed him on authority he already exercises, including negotiating the administration’s drug-pricing deals. The HELP Committee holds its hearing on FDA commissioner nominee Heidi Overton Sept. 24, and Chairman Bill Cassidy says he needs to hear her call President Trump’s claim that the measles vaccine is lethal absurd.
- Dems Grill Klomp On Vaccines, Mifepristone, ‘Secretive’ MFN Deals
- Senators highlight the power Chris Klomp wields at confirmation hearings
- Klomp Pledges More Communication With Congress, Transparency
- HELP Committee To Hear From Overton, Vote On Saphier Nomination Next Week
- Bill Cassidy Urges FDA Nominee To Reject Trump’s Vaccine Claim
Tags: #ALL
Also on the Hill
House Democrats are weighing a Medicare for All agenda should they retake the chamber, while Senate Finance ranking member Ron Wyden explores a narrower Medicare-type public option.
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Notable Notes
Census Finds the Uninsured Rate Stuck at 7.9% as Coverage Losses Loom
New Census Bureau data show 26.7 million people, or 7.9% of the population, were uninsured in 2025, statistically unchanged from 2024, with Medicare enrollment up and Medicaid enrollment down. The Bureau did not release the American Community Survey on schedule, leaving state and child uninsured estimates unavailable. Projections point the other way for young adults: the Urban Institute estimates up to 2.3 million could lose Medicaid by 2028, and more than 1 million could lose marketplace coverage that year.
- Uninsured Rate Stagnates As Hospitals Brace For Uncompensated Care
- Census Bureau: Uninsurance rates held steady from 2024-2025
- Census Bureau Releases Some New Data on Child Uninsured Rate, but Questions Remain
- 2.3M young adults could lose Medicaid due to Big Beautiful Bill: study
- Urban Institute: Over 1 Million Young Adults Could Lose Marketplace Coverage In 2028 Due To H.R. 1
- Insurance Doesn’t Protect US Adults From Medical Debt, Commonwealth Fund Finds
- Health Care Access and Affordability for Adults with Multiple or Complex Health Conditions: A Snapshot of Patient Experiences
- About Half Of Health Insurance Denials Get Reversed, Analysis Finds
Tags: #PATIENT #PAYER
Hospital Margins Slip to 1.4% as Elective Volume Softens
Kaufman Hall put hospital operating margins at 1.4% in July, down from 2.2%, as bad debt and charity care rose and elective surgery slowed. HCA’s chief financial officer tied softer elective volume to patients losing exchange coverage, even as health system CEOs expect the shift to outpatient care to continue into 2027.
- Hospital margins drop to 1.4% as bad debt, charity care soar
- Hospital Margins Fell This Summer Amid Outpatient Slowdown, Data Shows
- HCA sees elective surgery ‘slowdown’ as coverage erodes
- The ambulatory boom is far from over, CEOs say
- Why hospitals are losing the ‘increasingly unsustainable’ payer automation race
Tags: #HOSPITAL
Structural Heart Evidence Roundup: Redo TAVR, Valve-in-Valve and Access
This week’s structural heart literature centered on what happens after a first transcatheter valve. A U.S. registry found redo-TAVR with self-expanding valves carried low complication rates and outcomes comparable to native-valve TAVR, and a new viewpoint proposes a common language for valve-in-valve planning. Other work compared TAVR with medical therapy in paradoxical low-flow, low-gradient stenosis and described a workflow for surfacing the barriers that delay timely TAVR.
- Redo–Transcatheter Aortic Valve Replacement With Self-Expanding Valves: A U.S. Registry Analysis
- Outcomes of Supra-Annular vs Intra-Annular Self-Expanding Valves in Valve-In-Valve Transcatheter Aortic Valve Replacement
- Redo TAVR With Fluoroscopic-Free Surgical Resection of Prosthetic Valve Leaflets Under Direct Vision (SURPLUS) Technique
- A Proposed Common Language to Harmonize Valve-in-Valve TAVR (TAV-in-SAV and TAV-in-TAV) Procedural Planning
- Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis: REBOOT-PARADOX
- A Health Equity Workflow for Timely Transcatheter Aortic Valve Replacement: Making Barriers Visible
- Ultra-Early Transcatheter Edge-to-Edge Repair Intervention With Mechanical Circulatory Support for Post-Infarction Papillary Muscle Rupture
- Human Ex Vivo Working-Heart Evaluation of Coronet-Framed Valve-Sparing Aortic Root Replacement
- [PDF] THE EVOLUTION OF TRANSCATHETER INTERVENTIONS IN STRUCTURAL CARDIOLOGY
- When to Screen Older Patients for Valve Disease?
- Late-breaking clinical trials announced for TCT 2026 in San Diego
- Last Chance to Comment: SCAI Position Statement on Procedural Volume Reporting Requirements
Tags: #DEVICE #PROVIDER
Congenital Heart Care: Follow-Up, Mental Health and Outcomes
Research this week measured where children with congenital heart disease fall out of care. A single-center review of 1,060 patients found 46% missed two or more cardiology appointments; missed visits rose with neighborhood deprivation, and patients who missed more visits had more emergency visits and admissions. Mental health disorders are the most common comorbidity in congenital heart disease, yet many children do not receive adequate care for them.
- The effect of area deprivation on missed cardiology appointments and subsequent acute hospital visits
- Addressing Mental Health Needs in Pediatric Congenital Heart Disease
- The Heart of the Matter—Transforming Congenital Heart Disease Care through Patient-Reported Outcomes
- Safety and Outcomes of Same-Day Discharge After Elective Cardiac Catheterization for Congenital Heart Disease: A Single-Center Propensity-Matched Cohort Study
- 3D printing, VR playing a major role in congenital heart imaging
Tags: #PATIENT #PROVIDER
Also Worth Noting
Ten new medical schools were announced in 2026 without matching growth in residency slots, against a projected shortage of 141,160 physicians by 2038, and the accrediting body for residents is weighing shorter rest periods between shifts. The World Health Organization reports more than 3 in 10 physicians in high-income countries are 55 or older. A federal judge blocked the administration’s four-year visa cap for graduate students and postdoctoral researchers.
Tags: #PROVIDER #HOSPITAL