Weekly Spotlight
The Marketplace Shrinks
CMS is canceling about 315,000 federal marketplace enrollments covering more than 760,000 people, saying agents and brokers submitted the applications without required documentation such as Social Security or immigration numbers, and expects to recover roughly $2.2 billion in subsidies, according to the agency’s announcement. HHS told Inside Health Policy it first flagged broker-submitted applications missing those numbers, then checked for enrollments with no record of contact with the insurer, no medical claims and a $0 premium. HealthExec notes that many of the enrollees may have been signed up without their knowledge; Fierce Healthcare also reported the cancellations.
An interim final rule published Sept. 23 pauses registration of new agents and brokers on HealthCare.gov. CMS says new brokers were a small share of broker-assisted enrollments but a disproportionate share of those flagged. Brokers registered for 2026 can keep enrolling consumers when open enrollment begins in November.
Coverage is eroding from the other direction as well. KFF Health News reports health workers are going uninsured, including a Boise family-medicine couple whose premiums reached nearly $1,600 a month, and Reutersdescribes people sorting through alternatives after dropping marketplace plans. An eHealth survey of businesses with 500 or fewer employees, reported by Becker’s, finds 73% are considering dropping traditional group coverage for 2027. KFF’s Women’s Health Survey finds costs lead insured women to delay care and ration medications. The administration, meanwhile, is promoting individual coverage HRAs under a new name, CHOICE arrangements (Modern Healthcare).
Tags: #PAYER #PATIENT
Centers for Medicare and Medicaid Services (CMS)
Medicaid: A Work-Requirement Suit, Rate Uncertainty and a Quality Pledge
Five Medicaid enrollees, represented by the National Health Law Program and joined by the American College of Physicians, the American Academy of Pediatrics and other groups, sued to block CMS’s rules for the work requirements’ medically frail exemption before enforcement begins in 2027. KFF finds the reconciliation law’s financing, work-requirement and redetermination changes will make managed care rate-setting harder and could push plans to exit state programs. Separately, 37 states joined CMS’s Investing in Health Outcomes initiative, and KFF warns a proposed census rule excluding many noncitizens could reduce federal funding for Medicaid and CHIP.
- Lawsuit from Medicaid enrollees, provider advocacy groups challenges ‘Big, Beautiful’ work requirements
- Implementation of 2025 Reconciliation Law: Medicaid Managed Care Rate Setting Uncertainty & Potential Plan Exits
- CMS Launches State Health Quality Pledge To Further Medicaid Outcomes
- Proposed Changes to Demographic Data Collection in the Census Could Impact Efforts to Address Health and Health Care Disparities
Tags: #PAYER #PATIENT
Medicare Advantage: MedPAC Defends Its Number as Oz Warns of Weeds
MedPAC Chair Amol Navathe defended the commission’s estimate that Medicare will spend 14%, or $76 billion, more this year on Medicare Advantage enrollees than it would in traditional Medicare, speaking Tuesday at a Better Medicare Alliance event. In a video aired at an MA industry event the same day, CMS Administrator Mehmet Oz called the program a garden “vulnerable to weeds and overgrowth,” a sign the administration still wants tighter oversight.
- MedPAC Chair Defends Medicare Advantage Overpayment Analysis At Insurer Lobby Event
- Oz: Medicare Advantage A Garden ‘Vulnerable To Weeds And Overgrowth’
Tags: #PAYER
Drug Pricing: GENEROUS Claims and MFN Terms Under Scrutiny
The administration’s Sept. 18 claim that all 50 states had joined its GENEROUS Medicaid drug-pricing model overstated state interest, STAT reports; some states are still weighing whether it beats the deals they have, and GLP-1 weight-loss drugs may be a major exception. An updated estimate from a Mass General Brigham study’s lead author finds the most-favored-nation deals with 26 drugmakers could cut projected savings from the proposed GLOBE and GUARD Medicare models by nearly 80%, and newly released deal details are renewing concerns that the policy favors manufacturers. A drug-pricing group is also fighting a draft congressional letter urging CMS to drop a negotiation-rule provision on fixed-dose combination drugs.
- Trump’s Medicaid Drug Pricing Boast Overstated State Interest
- Did the Trump administration just cut Novo a huge financial win?
- A hidden tradeoff in Trump’s MFN drug deals
- New MFN deal details reignite concerns that Trump’s pricing policy favors pharma
- Drug-Pricing Group Rallies Against Unnamed Letter Urging Lawmakers To Oppose Fixed-Dose Combo Policy
Tags: #DRUG #PAYER
CMMI Closes Out Two Bundles and Readies CJR-X
The Innovation Center’s final evaluations credit BPCI Advanced with more than $800 million in net Medicare savings over eight model years and the Comprehensive Care for Joint Replacement model with $180 million, with quality preserved. BPCI Advanced did not meet the criteria for expansion, and CMS says its lessons carry into the Transforming Episode Accountability Model, which began Jan. 1, 2026. CJR expands nationwide as the mandatory CJR-X model in 2028. The AMA separately asked CMMI to test a model that helps people approaching Medicare eligibility choose coverage.
- BPCI Advanced Final Evaluation Shows $800M in Net Savings
- Innovation Insight: Final CJR Evaluation Report Shows $180M in Savings Ahead of Nationwide Expansion
- AMA Asks CMMI To Test New Medicare Informed Choice Model
Tags: #HOSPITAL #PROVIDER #PAYER
Insurers and Senators Push Back on Medicare’s Remote Monitoring Limits
UnitedHealth and CVS want CMS to replace the proposed 2027 physician fee schedule restrictions on remote patient monitoring with targeted guardrails on RPM vendors, and a bipartisan group of senators asked CMS to drop the language, warning it would cut off remote care in rural and underserved areas.
STAT (subscription) Inside Health Policy
Tags: #DEVICE #PROVIDER #PAYER
Also in CMS
CMS released 2025 MIPS final scores, which set 2027 payment adjustments; clinicians can request a targeted review until 30 days after the adjustments post. The AMA urged CMS to hold payers to the 2027 electronic prior authorization deadline (Fierce Healthcare, Becker’s). A federal judge dismissed a provider group’s suit seeking to force Cigna to pay a $3 million No Surprises Act arbitration award, finding the law gives courts no role in enforcing payment.
Tags: #PROVIDER #PAYER
Food and Drug Administration (FDA)
FDA Advisers Back Grail’s Galleri Multicancer Test Despite Data Gaps
FDA’s Molecular and Clinical Genetics Panel voted Sept. 23 that Grail’s Galleri multicancer early detection blood test is safe (10-0) and effective (6-4) and that its benefits outweigh its risks (7-2, one abstention). Panelists acknowledged there is no proof yet that the test reduces cancer deaths, and the NHS-Galleri trial missed its primary endpoint earlier this year. The test looks for a cancer signal in a single blood draw and is meant to supplement guideline screening, not replace it. FDA now decides on approval.
MedPage Today Medscape The Hill Fierce Biotech
Tags: #DEVICE #PATIENT #PROVIDER
Overton Tells Senators the White House Sets FDA’s Priorities
At her Sept. 24 HELP Committee hearing, FDA commissioner nominee Heidi Overton said the president should set policy priorities while she oversees product review, and she largely declined to give her own views on vaccines, abortion-pill access and vapes. Two former commissioners said beforehand they expect her to run the agency independently; Chair Bill Cassidy and a consumer advocacy group questioned her close White House ties.
Inside Health Policy STAT (subscription) Inside Health Policy The Washington Post (subscription)
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FDA’s Device Center: Foreign Data, Robotic Surgery and Emerging Technology
A CDRH official told RAPS Convergence that FDA accepts clinical data from outside the U.S. when the studies follow good clinical practice and the data apply to the regulatory question. FDA issued draft guidance on premarket submissions for robotically assisted surgical devices and set a Dec. 2-3 workshop, and CDRH and the Medical Device Innovation Consortium are seeking input on regulating devices used without direct clinician oversight. GAO found FDA should strengthen its policies for auditing the third-party organizations that conducted the initial review of 617 510(k) submissions from fiscal 2018 through 2025. CDRH also released a patient course on real-world data across the device life cycle.
- Convergence: Thinking past GCP compliance for regulatory acceptability of foreign trial data
- Robotically-Assisted Surgical Devices—Premarket Submissions (draft guidance)
- FDA, MDIC Seek Input On Challenges With Regulating Emerging Medical Technology
- Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations
- CDRH Patient Education Program Course 2 Video: Patient-Generated and Real-World Data Throughout the Medical Device Life Cycle
Tags: #DEVICE
Also in FDA
FDA removed animal-testing references from its drug and biologic regulations in a direct final rule. New CDER Director Mike Davis said precision medicine may be the future of evidence generation. Former Commissioner Robert Califf said the 1962 and 1976 laws need an update for AI and other products that change after launch, and FDA leadership published an “America First” essay on medical innovation.
Tags: #DRUG #DEVICE
Department of Health and Human Services (HHS)
The White House Drops Its NIH Grant Commission
The White House is scrapping a planned executive order that would have required a panel of political appointees to sign off on NIH grants, a person familiar with the matter told Roll Call Sept. 23. The plan drew bipartisan objections after a contentious White House meeting, including a Sept. 22 letter from Senate Appropriations Chair Susan Collins. NPR charts how NIH disruptions have shifted from terminations to delayed awards and rerouted funds. NIH also proposed a policy on returning summary study results to trial participants and launched an experimental AI search tool for PubMed.
- White House Drops Executive Order For Tighter NIH Purview
- Susan Collins Urges White House To Drop Plan For National Institutes Of Health Grant Oversight
- Members of Congress push back on plan to create a commission of political appointees to review NIH grants
- Under Trump, NIH Funding Disruptions Have Evolved, Experts Say
- Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants
- NIH Says PubMed AI Tool Part Of Replication And Reproducibility Effort
Tags: #ALL
Vaccines and the CDC: Covid Shots Released, Recommendations Stalled
States can now order updated Covid vaccines through the Vaccines for Children program, which covers nearly half of U.S. children, after weeks of delay. The AP reports the CDC’s vaccine recommendation process has ground to a halt under Secretary Kennedy, and The New York Times describes a “zombified” agency hobbled by cuts.
- States Can Now Access Covid Vaccines For Low-Income Children, After Delay
- CDC Vaccine Policy Recommendations Grind To A Halt Under Kennedy
- ‘Zombified’ C.D.C., Hobbled By Cuts, Struggles To Fulfill Scientific Mission
Tags: #PATIENT #PROVIDER
HHS Capacity: Staff Losses, a RIF Settlement and a $1 Billion Clawback
A new report finds that although Congress rejected many proposed HHS cuts, workforce losses have left agencies with less capacity to run the programs lawmakers fund. Federal unions settled their suit over 2025 shutdown-era layoffs, requiring agencies to remove reduction-in-force authority from shutdown plans. The White House used a rarely invoked rescission power to cancel nearly $1 billion in congressionally approved spending, most of it for HHS programs serving refugees and unaccompanied minors.
- Report: HHS Program Operations Strained By Staffing, Funding Cuts
- Unions Win Settlement In Shutdown RIF Case Against HHS, Other Depts.
- Trump administration uses rare authority to claw back nearly $1B in spending approved by Congress
Tags: #ALL
340B: A Rebate-Ban Push and a Charity-Care Fight
The American Hospital Association is seeking a permanent ban on the 340B rebate model pilot. A Pioneer Institute and CancerCare analysis found 340B hospitals spent 2.16% of operating expenses on charity care, against 2.82% at other hospitals; a hospital group called it misleading.
- AHA seeks permanent 340B rebate ban: 6 things to know
- 340B Hospitals Lag Behind Peers In Charity Care Spending: Report
Tags: #HOSPITAL #DRUG
Also in HHS
HRSA announced changes to strengthen the OPTN’s transplant data infrastructure. Senate Democrats questioned whether Secretary Kennedy kept a stake in Gardasil litigation he pledged to divest, and congressional Democrats pressed him on an undisclosed change to his ethics agreement involving law-firm fees.
Tags: #ALL
Heard on the Hill
Finance Advances Klomp 15-12 as WISeR and MFN Questions Follow
The Senate Finance Committee advanced Chris Klomp’s nomination for HHS deputy secretary 15-12 on Sept. 24, with Sen. Sheldon Whitehouse the only Democrat in favor, and also advanced Ge Bai as assistant secretary for planning and evaluation. In written answers, Klomp declined to confirm documents senators say show CMS plans to extend the WISeR prior-authorization model to oncology care and cardiac catheterization. Ranking member Ron Wyden says he will keep opposing Klomp until the administration releases the most-favored-nation contracts Klomp helped negotiate.
- Finance Advances Klomp, Bai For Full Senate Vote; Wyden Vows To Keep Pressing HHS On MFN Deals
- Senate Panel Clears Chris Klomp To Be RFK Jr.’s Top HHS Deputy
- Senate Finance Committee advances Klomp’s nomination as HHS Deputy Secretary
- Klomp Sidesteps Confirming WISeR Will Be Expanded To Oncology, Cardiac Care
- Democrats Again Demand Trump’s Drug-Price Contracts Following Post Report
Tags: #ALL
Physician Pay: The Patients First Act Takes Shape
Congress is weighing the Patients First Act, which would tie Medicare physician pay to medical inflation, and both parties appear to agree on its outlines. Axios explains why Congress can’t avoid the scheduled cuts to physician pay.
- Patients First Act: Congress Mulls Change In Medicare Doctor Pay
- Why Congress Can’t Avoid Medicare Cuts To Docs
Tags: #PROVIDER
Health Costs and the Midterms
House Democrats’ 84-page health agenda, obtained by Politico, would rein in large health care companies and expand Medicare if they win the House. Sen. Elizabeth Warren and colleagues introduced the Stop Corporate Takeovers of Physicians Act to limit private-equity ownership of medical practices, and Axios reports costs have become a defining issue in battleground races.
- House Democrats want to rein in healthcare giants, expand Medicare: Report
- Bill Takes Aim at Private Equity’s Role in Healthcare
- Health Care Costs Stoke Midterm Battleground Races
Tags: #ALL
Also on the Hill
Employer and PBM lobbies jointly urged Congress to pass drug patent reform before the session ends, and a new coalition of employers and physicians is lobbying to expand direct contracting.
Tags: #PAYER #DRUG
Notable Notes
AI in Health Care: Costs, Coding and New Partnerships
A Blue Cross Blue Shield Association analysis finds hospitals using AI coding tools billed its plans $942 million more for comparable care. Oz said AI will be inflationary in the short term and argued that AI fraud detection can’t wait, and Medscape reports federal officials are weighing paying for AI tools at 60% to 80% of what clinicians receive for the same work. President Trump announced an “AI Force” and an AI czar, and in a KFF commentary former White House official Joe Grogan argues the bigger risk is the wrong kind of regulation. Cigna is building AI support for cancer patients with OpenAI, and Anthropic partnered with OpenEvidence on a free clinical evidence tool for clinicians in about 100 low- and middle-income countries and reported its first AI-assisted biology discovery.
- Hospitals’ use of AI coding tools cost BCBSA plans $942M more for similar care: analysis
- AI will inflate healthcare costs before lowering them, Oz says
- ‘They steal the nation’s trust’: Dr. Oz on why fraud detection can’t wait
- How Should Doctors Be Paid for Using AI Tools?
- Trump vows ‘AI Force,’ AI czar as health systems eye policy shift
- AI: To Regulate, or Not to Regulate?
- Cigna Group, OpenAI team up to support patients with complex conditions
- Cigna Group, OpenAI Partner To Expand Complex Care Offerings
- Anthropic, OpenEvidence partner to bring medical AI worldwide
- Anthropic’s A.I. Is Teaching Itself Biology. Now It’s Made Its First Discovery
- Anthropic says Claude AI helped discover novel enzyme system
Tags: #ALL
Structural Heart Evidence: TAVR Timing and CT Surveillance
A single-center retrospective study of 149 patients in Open Heart ties waits of more than six months from severe aortic stenosis diagnosis to TAVR with worse long-term outcomes. A Journal of Cardiovascular Computed Tomography study finds photon-counting CT comparable to transthoracic echocardiography for evaluating valve dysfunction after TAVR, without sedation.
- TAVR timing: Waiting more than 6 months may hurt survival odds
- Photon-counting CT accurately screens TAVR patients for signs of valve dysfunction
Tags: #DEVICE #PROVIDER
Congenital Heart Care: A Catheter-Based Fontan and Patients Brought Back to Care
Nicklaus Children’s Hospital performed what it believes is the first completely catheter-based Fontan in the U.S., sparing a 2-year-old a third sternotomy and cardiopulmonary bypass. At Children’s National, 16% of 1,555 patients who had congenital heart surgery had gone at least 18 months without a cardiologist visit, and a nurse-led outreach program reconnected more than a third of them. Other work this week: a quality-review guide built on real-time STS Congenital Heart Surgery Database data, a trial of pulse oximeter accuracy across skin pigmentation in children with congenital heart disease, and a review of point-of-care echocardiography for newborn heart lesions.
- First heart procedure of its kind performed in US after careful planning
- Nurse-led outreach re-engages cardiac surgery patients lost to follow-up
- Collaborative Multidisciplinary Assessment of Performance: A Development Guide for Pediatric Heart Centers
- Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
- Diagnostic Performance and Clinical Impact of Point-of-Care Echocardiography for Early Detection of Neonatal Cardiac Lesions: A Systematic Review
Tags: #PATIENT #PROVIDER
Also Worth Noting
The AMA and AHA asked DHS to exempt physicians and other health care workers from the proposed $103,265 H-1B visa fee. UnitedHealthcare, Cigna and Centene are sharing a credentialing process through CertifyOS. KFF finds TrumpRx prices are about as likely to be higher as lower than prices in 11 other wealthy countries. A rare-disease coalition asked that all orphan drugs be exempted from Section 232 tariffs. Steri-Tech will pay $700,000 and cut ethylene oxide emissions at its Salinas, Puerto Rico, sterilizer by 99.99% under a proposed EPA and DOJ settlement.
Tags: #ALL