Weekly Spotlight
Checks Before the Midterms
President Trump announced late Friday that more than 20 million Medicare Part B enrollees will receive one-time $90 payments to help with premiums, a month before the Nov. 3 midterm elections, the Associated Press reports. The White House said the money will come from the Medicare Improvement Fund, which Congress created in 2008. Senate Finance ranking member Ron Wyden said the payments, to nearly 21 million people in traditional Medicare, will drain the $2 billion fund (Inside Health Policy).
The Medicare payments follow the $500 Affordable Care Act “refund” checks announced in September. The Treasury Department began mailing those checks Wednesday to more than 950,000 people in the 30 states that use HealthCare.gov (The Hill). Trump told an Ohio rally Saturday that 70,000 families in the state would receive them “within the next couple of days,” according to the AP.
The election is shaping the health policy calendar in other ways. Politico reports that the political cost of the 2025 reconciliation law is arriving before the vote, even though the law delayed its cuts to Medicaid and other health programs until after the midterms. STAT surveys the debates the election could reopen, from Medicaid funding to drug prices, and reports that five or more of the Senate Finance Committee’s 14 Republicans are set to leave, with the health committee also facing turnover.
Tags: #PATIENT #PAYER
Centers for Medicare and Medicaid Services (CMS)
Medicare Advantage Pulls Back for 2027
CMS’s 2027 plan data, released Sept. 28 ahead of open enrollment (Oct. 15 to Dec. 7), show the largest insurers trading membership for margin. The headline numbers look stable: CMS projects the average monthly premium falling from $14.37 to $12, the total number of Medicare Advantage plans slips from 5,553 to 5,532, and insurers project 34 million enrollees, about 2 million fewer than today. Underneath, every major insurer cut individual plans, according to a Stephens analysis cited by Healthcare Dive; 181 counties will have no Medicare Advantage plan, up from 67 this year; and at least 11 insurers that sold individual plans this year, almost all owned by health systems, are leaving the program. Bloomberg reports at least 1 million people will have to switch plans, including about 390,000 in UnitedHealth plans that are closing and about 600,000 in plans Humana is cutting. Dental allowances and Part B premium givebacks are shrinking even as insurers’ announcements describe robust offerings. Separately, new enrollment in dual-eligible special needs plans will be limited in 2027 to people in the same carrier’s Medicaid plan where the plan holds a state Medicaid contract in an overlapping service area; KFF finds stand-alone drug plan options falling for a fourth year; and MedPAC takes up physician participation in Medicare Advantage networks on Oct. 8.
- Here’s how much insurers are cutting Medicare Advantage plans for 2027
- CMS projects lower Medicare Advantage premiums in 2027
- Medicare Advantage Insurers Cut Plans, Exit More Counties In 2027
- Medicare Advantage Insurer Exits Pile Up For 2027
- UnitedHealth, Humana Drop Medicare Advantage Plans To Boost Profit
- Insurers say their 2027 Medicare Advantage offerings preserve benefits. The data tells a different story
- Medicare Advantage Insurers Face New CMS D-SNP Enrollment Limits
- Many Medicare Part D Stand-Alone Drug Plan Enrollees Will See Modest Premium Increases for 2027, But Others Could Pay Much More If They Don’t Switch Plans
- MedPAC public meeting, October 8-9, 2026
Tags: #PAYER #PATIENT
Medicaid: Proof of Frailty, a Bid for Delay and a Provider Tax Fight
Work requirements for Medicaid expansion adults begin in January, and at least six Republican-led states are demanding documentation of medical frailty immediately, though federal rules let states take an enrollee’s word for the first year, the AP reports. The governors of Oregon, California, Maine, New York and Virginia told HHS that states cannot meet the Jan. 1 date while protecting beneficiaries, pointing to a June interim final rule that gave states less leeway than they expected. The HHS Office for Civil Rights issued guidance Sept. 29 on when state agencies may use substance use disorder treatment records to verify an exemption. On financing, hospital groups told CMS its July 21 provider tax proposal goes well beyond the 2025 law, noting that CMS projects about $246 billion in federal savings against the $183 billion estimated at enactment, and state Medicaid directors disputed the agency’s claim that the 75/75 test it wants to sunset is rarely used.
- States Tell Patients To Prove They’re Too Sick For Medicaid Work Requirement
- Governors ask HHS for more time to implement Medicaid work requirements
- HHS Office for Civil Rights Clarifies Privacy Rules for State Medicaid Programs
- Medicaid tax rule goes beyond the statute, say hospitals
- NAMD Rejects CMS Claim 75/75 Test For Provider Taxes Rarely Used
Tags: #PAYER #PATIENT #HOSPITAL
Drug Pricing: A Smaller GLOBE Goes Final and Every State Signs GENEROUS
CMS finalized the GLOBE model, a mandatory Medicare Part B test that will collect manufacturer rebates when a drug’s price exceeds an international benchmark; it starts Jan. 1, 2027, and runs through March 2032. The final rule is far narrower than the proposal. It is projected to save $440 million over seven years, down from $11.9 billion, and STAT reports it applies to four companies because manufacturers with most-favored-nation agreements are exempt. CMS also says all 50 states signed final agreements to join GENEROUS, its Medicaid most-favored-nation pricing model, by the Sept. 30 deadline.
- Global Benchmark for Efficient Drug Pricing (GLOBE) Model (final rule)
- CMS Significantly Scales Back GLOBE MFN Demo
- Trump’s watered-down Medicare drug pricing rule saves 96% less than initial proposal
- CMS Says All States On Board To Participate GENEROUS Following Final Deadline
Tags: #DRUG #PAYER
Breakthrough Devices Lose Their Shortcut to Medicare Add-On Payments
Devices that receive FDA breakthrough designation from October on no longer get special treatment when they seek supplemental Medicare payment, STAT reports. Since 2020, the designation had let a device qualify for new technology add-on payments and transitional pass-through payments without showing substantial clinical improvement over existing options. CMS repealed the alternative pathway for both payments in the fiscal 2027 hospital payment rule issued July 31, effective with fiscal 2028 applications, with a transition for devices designated by Sept. 30. STAT’s tracker counts nearly 800 devices reported to have breakthrough status since 2022.
Tags: #DEVICE
Coverage Losses and the Employer Pivot
Marketplace enrollment was 2.2 million lower in February than in December, after the enhanced premium tax credits lapsed, according to the Center on Budget and Policy Priorities’ coverage tracker. Hospitals are starting to see the effect: in an Evercore ISI survey of 25 hospital executives, 24% reported slower procedure volumes, with aortic and mitral valve replacement among the procedures most often affected, and 56% said volumes could take a hit within six to 12 months. CMS Administrator Mehmet Oz urged employers in Austin on Sept. 30 to consider CHOICE arrangements, the rebranded individual coverage health reimbursement arrangements. And Wakely actuaries say CMS’s cancellation of about 315,000 marketplace enrollments could alter insurers’ risk pools, risk adjustment transfers and pricing for 2027 and 2028.
- Health Coverage Tracker: Millions of People Are Losing Coverage Following 2025 Republican Policy Changes
- ACA subsidy lapse slows procedures at nearly 1 in 4 hospitals: Survey
- ‘You need to look into it’: Dr. Oz pitches CHOICE health plans to small businesses
- CMS Marketplace Anti-Fraud Actions: Financial and Strategic Implications for ACA Health Insurers
Tags: #PAYER #PATIENT #HOSPITAL
Also in CMS
The final Transparency in Coverage rule, which updates what insurers and group health plans must publish about negotiated prices, cleared White House review. An executive order directs agencies to connect their systems to America.gov, a White House site that uses AI to deliver government information and, eventually, services such as Medicare enrollment. CMS’s proposed physician fee schedule asks whether the annual wellness visit should be driven more by AI and less by physicians. Blue Shield of California, one of 17 health plans that committed to payment models inspired by the ACCESS Model, expects to launch commercial versions in 2027. And air ambulance operator PHI Health sued Elevance Health subsidiaries and employers over about $30 million in unpaid No Surprises Act arbitration awards.
Tags: #PAYER #PROVIDER #PATIENT
Food and Drug Administration (FDA)
FDA Approves Edwards’ Autus Valve, the First Built to Grow With a Child
FDA on Oct. 1 approved Edwards Lifesciences’ Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for children with congenital pulmonary valve disease. The valve is the first designed to be expanded after surgery to keep pace with a child’s growth: it can be implanted at about 13 millimeters and widened by balloon catheter to 22 millimeters, comparable to an adult pulmonary valve, which may spare children repeat open-heart operations. FDA said it is also the first valve approved in the U.S. with polymer rather than animal-tissue leaflets. Autus came through premarket approval, held breakthrough device designation and is the first pediatric approval from FDA’s Total Product Life Cycle Advisory Program. The pivotal study enrolled 62 children at 12 U.S. sites. All patients were free of device-related complications through 30 days, and none needed a valve reintervention through six months. The first 60 showed acceptable blood flow and no more than mild leakage at six months, and two children who began to outgrow the valve had it expanded without surgery. FDA also noted three valve-frame fractures and two cases of reduced leaflet movement, none causing symptoms. Patients will be followed for 10 years. Edwards acquired Autus Valve Technologies in February for $128.9 million plus up to $132.5 million in milestone payments.
Cardiovascular Business MedTech Dive
Tags: #DEVICE #PATIENT #PROVIDER
Overton’s Confirmation Vote Slips Past the Midterms
The Senate health committee left for recess without scheduling a vote on Heidi Overton’s nomination to lead FDA, so the outcome will not be known until after the Senate returns Nov. 9; a single Republican defection could sink the nomination in committee, STAT reports. Opposition is organizing in the meantime. More than 2,500 physicians, in a Sept. 30 letter organized by the Committee to Protect Health Care, urged senators to reject her, citing her role in the executive order that split the measles, mumps and rubella vaccine into separate shots and her past writing on medication abortion. The Center for Science in the Public Interest also urged senators not to confirm her.
STAT (subscription) Becker’s Hospital Review CIDRAP
Tags: #ALL
Device Center: A Regulatory Science Agenda, Home-Device Picks and Adviser Recruitment
FDA and the Medical Device Innovation Consortium opened a discussion of the regulatory science tools the device center will need over the next decade. Director Michelle Tarver said autonomous AI, bioelectronic medicine and next-generation implantables call for new evidence pathways, and Stanford’s Josh Makower warned that early-stage device capital is at the lowest point of his career. The center named the first five participants in READI-Home, its challenge to develop home devices that reduce readmissions: BD, Epitel, Prapela, Current Health and Skribe Medical. Prapela’s entry is a vibrating crib mattress for infants with single-ventricle heart disease. FDA also began recruiting scientific members and consumer representatives for its advisory committees, and Medtronic received breakthrough designation for a drug-coated balloon for peripheral artery disease below the knee.
- FDA seeks new regulatory science framework for innovative tech
- FDA selects first 5 participants for READI-Home initiative
- FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
- Medtronic drug-coated balloon gets FDA breakthrough status
Tags: #DEVICE
Also in FDA
CDER Director Mike Davis said the drug center is turning to AI to preserve institutional knowledge as it rebuilds its workforce. FDA’s unified Adverse Event Monitoring System entered a new phase Oct. 1, requiring manufacturers that file certain postmarket safety reports electronically to use its newer standard. Three nonprofits are opening a federally funded center to help sponsors generate data with alternatives to animal testing, and FDA pledged more transparency on those programs and on its evaluation of direct-to-consumer advertising. A speaker at FDA’s user fee hearings argues that patient safety should be part of the negotiations.
Tags: #DRUG #PATIENT
Department of Health and Human Services (HHS)
340B: Ten Drugmakers Cleared for the Rebate Pilot as CMS Opens Its Claims Repository
HRSA named 10 manufacturers, among them Pfizer, AbbVie, Merck and AstraZeneca, and 21 drugs for its revised 340B rebate pilot, which starts Jan. 1 and replaces upfront discounts with rebates paid after covered entities submit claims-level data. Hospital CEOs told Becker’s they expect cash flow and administrative strain, and the American Hospital Association has asked Congress to bar rebate models permanently. CMS opened its Part D 340B claims repository Oct. 1 for voluntary submissions and has proposed making them mandatory Jan. 1, 2027, the day the pilot begins. A Berkeley Research Group report estimates patients and payers spent $244.3 billion on 340B drugs in 2025, more than double the 2021 figure, and a STAT opinion piece argues the pilot collides with the program’s treatment of orphan-designated drugs that have several uses.
- HRSA names drugmakers, products for revised 340B rebate pilot
- What 340B rebates could mean for hospital cash, staffing, per CEOs
- CMS opens new portal ahead of mandatory 340B data deadline: 4 things to know
- CMS proposes new 340B reporting requirements
- What patients and payers pay for 340B drugs: 6 study notes
- Outdated 340B Policy On Orphan-Designated Drugs Must Be Fixed
Tags: #HOSPITAL #DRUG
Kennedy Says AI Outperforms Doctors; Physician Groups Object
HHS Secretary Robert F. Kennedy Jr. told the MAHA Summit on Sept. 29 that AI gives patients “a second opinion that is much better informed than any doctor in the country,” The New York Times reported, and framed it as a tool for challenging guidance from public officials and medical experts. A day later the American Medical Association and five other physician groups said such statements risk undermining trust in physicians. The remarks followed a Sept. 28 MAHA Institute event where Kennedy argued for opening health data to researchers, saying user agreements let institutions decide who can study the data and what questions they can ask.
- RFK Jr: AI second opinions are ‘better informed than any doctor’
- Top Physician Groups Cry Foul After RFK Jr. Urges Patients To Trust AI Over Health Experts
- Why MAHA wants to make health data much more accessible
- RFK Jr.’s AI push hinges on health data
Tags: #PROVIDER #PATIENT
ARPA-H Names the Teams Building Heart Failure AI
The Advanced Research Projects Agency for Health awarded contracts under ADVOCATE, its four-year, $62.7 million program to build patient-facing and supervisory AI for heart failure care, to teams including Kaiser Permanente, Duke, Stanford, Atman Health, Updoc and Tempus AI, with up to $33.7 million committed in the first year. Stanford Medicine will receive up to $14.9 million to build STEWARD, a three-stage system that monitors AI agents in clinical use and that the team hopes can serve as a regulatory model; OpenAI is a partner. UC San Diego Health, Harvard Medical School and Anthropic are developing an open-source oversight system built around a “clinical constitution” for checking the safety of patient-facing AI recommendations.
- Government-funded program wants better AI for managing heart failure in the US
- Stanford, OpenAI team up to police healthcare AI agents
- Who checks patient-facing AI after go-live? UC San Diego Health, Anthropic are building an answer
Tags: #PROVIDER #PATIENT #DEVICE
Preventive Services Task Force: A Blocked Recommendation and a Senate Letter
The director of the Agency for Healthcare Research and Quality blocked the U.S. Preventive Services Task Force’s final recommendation on cervical cancer screening in fall 2025, and canceled meetings kept members from voting on a recommendation for preventing cardiovascular disease, former chair Michael Silverstein of Brown University wrote in an Annals of Internal Medicine commentary. He says the panel has been blocked from publishing any recommendation since July 2025. Sen. Angus King and 16 Senate Democrats separately asked Secretary Kennedy to explain his overhaul of the panel, whose recommendations determine which preventive services insurers must cover, and requested a response by Oct. 15.
Tags: #PAYER #PROVIDER #PATIENT
Fiscal Year-End: The $810 Million Rescission Stands Over GAO’s Objection
GAO told Congress on Sept. 29 that the Impoundment Control Act does not let the president withhold appropriated funds past their expiration, after the White House proposed on Sept. 25 to rescind money from 11 accounts, most of it for HHS programs serving refugees and unaccompanied minors. Sen. Ron Johnson then blocked Senate Democrats’ bill to stop the $810 million cancellation as the fiscal year ended Sept. 30, The Washington Post reports. The Hill reports the administration had also declined to spend billions of dollars in other health appropriations, including more than $1 billion for global health programs, which were at risk of expiring the same day.
- GAO decision B-338788: Review of the President’s Special Message of September 25, 2026
- Democrats fail to stop Trump from canceling $810M in funds approved by Congress
- Unspent healthcare funding faces do-or-die cliff
Tags: #ALL
Also in HHS
NIH spent its full external grants budget of roughly $34 billion in fiscal 2026 but kept reducing awards involving health disparities, race and ethnicity, a STAT analysis finds, and Senate appropriators from both parties are drafting language to shield NIH grantmaking from White House influence in the Labor-HHS bill they hope to pass before stopgap funding expires Dec. 11. HHS plans to revise the Common Rule governing research on human subjects to ease requirements for minimal-risk studies, and one bioethicist told Science the notice gives more attention to reducing burden than to safeguarding participants. HRSA finalized living donor reimbursement guidelines under the Honor Our Living Donors Act and published a three-year progress report on its overhaul of the transplant network. CDC’s proposed redesign of the National Health Interview Survey drops questions about disabilities, and a federal judge removed the integration mandate from Section 504 regulations after the Justice Department declined to defend it.
Tags: #ALL
Heard on the Hill
House Democrats Draft a First-100-Days Health Agenda
Working groups reporting to House Minority Leader Hakeem Jeffries are laying out what a Democratic majority would do first. Their proposals would block CMS from further implementing the WISeR prior-authorization model within the first 100 hours of the next Congress, create a federally administered Part D plan that bypasses pharmacy benefit managers, expand Medicare drug price negotiation, pursue permanent telehealth legislation within a year, and move the bipartisan doctors caucuses’ Medicare physician pay bill within the first 100 days. The agenda also calls for protections against political interference in vaccine recommendations and research grantmaking. In the Senate, Sen. Mark Warner introduced a package that would reverse the 2025 law’s Medicaid cuts, make the enhanced Affordable Care Act tax credits permanent and create a public option.
- House Dems Propose Blocking WISeR Within 100 Hours Of 120th Congress
- House Dems Offer Way To Sidestep PBMs Through Federal Part D Plan
- House Dems Eye Multi-Pronged Approach To Drug Pricing If They Regain Majority
- Democrats May Pursue Permanent Telehealth If They Take House
- Bipartisan Doc Caucuses’ Physician Pay Reform Bill In Dems’ First 100 Days Health Agenda
- House Dems’ Agenda Includes Bills To Protect ACIP, Health Grants
- Warner’s Wide-Ranging Health Reform Bill Reverses H.R. 1 Cuts, Creates Public Option
Tags: #ALL
Program Integrity: Energy and Commerce Republicans’ Fraud Package
House Energy and Commerce Chairman Brett Guthrie released “Continuing the Fight Against Fraud,” a package of 14 bills to expand data collection, strengthen enforcement and reward anti-fraud efforts in federal health programs. The committee’s majority staff also published a report with 13 findings and 37 recommendations on fraud in Medicare and Medicaid, including disparities in how states oversee their Medicaid programs. From the states’ side, the National Association of Medicaid Directors describes the integrity work already under way and the federal tools states want, among them a modernized national provider identifier system and a national view of claims data.
- E&C Republicans Introduce Critical Fraud-fighting Package to Protect Vulnerable Americans and Safeguard Taxpayer Dollars
- E&C Releases Staff Report Exposing How Fraudsters are Ripping Off Medicare and Medicaid and How More Must be Done to Protect These Programs
- Building on What Works in Medicaid Program Integrity
Tags: #PAYER #PROVIDER
Also on the Hill
The Senate health committee voted 12-11 to advance nominees for surgeon general and two assistant secretary posts; floor votes are unlikely before the election, and the Senate has left for recess. A resolution to overturn the administration’s 2027 exchange rule failed 48-51, with Sen. Susan Collins joining Democrats. The Senate passed Sen. Bill Cassidy’s health care cybersecurity bill, while Sen. Rand Paul blocked fast-track passage of the Patients Deserve Price Tags Act. Sens. Cassidy and Warner are revisiting legislation to expand the national drug acquisition cost survey, and Sens. Andy Kim and Lisa Murkowski introduced a bill to provide newborn supply kits. At least 85 organizations urged Congress to reauthorize the pandemic preparedness law, the American Hospital Association asked lawmakers to hold AI vendors outside HIPAA to its privacy and security standards, and Georgetown’s Center for Children and Families responded to Sen. Wyden’s request for coverage proposals.
Tags: #ALL
Notable Notes
Structural Heart: Mitral Outcomes After TAVR and After Heart Attack
A single-center study of 344 TAVR patients with moderate to severe mitral regurgitation at baseline, published in JACC: Advances, found the regurgitation improved by at least one grade in 62.8% of patients. Persistent regurgitation was more common in women, and among patients with low-flow, low-gradient aortic stenosis, residual severe regurgitation carried three times the mortality risk. An unadjusted analysis of 416 patients with myocardial infarction and mitral regurgitation, published as a research letter in the Journal of the Society for Cardiovascular Angiography and Interventions, found one-year mortality of 18.2% after transcatheter repair or replacement and 31.1% after surgery; the authors caution that the comparison is subject to confounding. Edwards and the Los Angeles Rams renewed a partnership offering valve disease education and free screenings in Los Angeles and Orange County, and the post-approval study of Edwards’ Alterra prestent with the SAPIEN 3 pulmonary valve is listed as active with enrollment closed.
- Persistent mitral regurgitation after TAVR more common among women than men
- Outcomes of Surgical Versus Transcatheter Mitral Valve Repair or Replacement in Patients With Myocardial Infarction and Concomitant Mitral Regurgitation: A Retrospective Analysis of Real-World Data
- L.A. Rams Extend Edwards Lifesciences Heart Health Partnership
- ALTERRA Post-Approval Study (NCT05378386)
Tags: #DEVICE #PROVIDER
Site of Care: Outpatient Drug Markups, Surgery Center Margins and an Insurer’s Billing Rules
Hospital outpatient departments were paid an average of 102% more per unit than physician offices for the same physician-administered drugs, a gap worth about $12.7 billion a year in commercial spending, or $101 per covered member, the Employee Benefit Research Institute found in 2023-24 claims for 106 drugs. Elevance Health will require providers to report the physical location of a service so that off-campus care is not billed at hospital rates. A JAMA report found roughly a quarter of Pennsylvania’s nonprofit ambulatory surgery centers reported margins above 51% and a quarter of for-profit centers margins above 29%. In HFMA, columnist James Mathews argues that site-neutral payment should not mean eliminating Medicare’s inpatient-only list.
- HOPDs paid 102% more for same drugs
- Hospital outpatient departments’ higher drug reimbursement rates drive $12.7B in spending: EBRI
- Elevance Health Rolls Out New Site-Of-Care Billing Policies
- Ambulatory Surgery Centers Post High Profits: JAMA Report
- Why site-neutral payment does not mean eliminating the IPO list
Tags: #HOSPITAL #PAYER #PROVIDER
Congenital Heart Care: Brain Injury Before Surgery and a Fetal Screening Grant
A review in Pediatric Research of 11 MRI cohort studies covering more than 1,500 infants finds brain injury in 12% to 54% of newborns with congenital heart disease before surgery, and concludes that injury often begins before the operation and continues afterward. A Worcester Polytechnic Institute researcher received a four-year, $2.9 million NIH award to build a model that uses fetal blood flow data to detect obstructions of the aorta before birth. Other work this week: case reports of repeat transcatheter valve-in-valve mitral procedures in small children and of transcatheter tricuspid valve replacement with Edwards’ EVOQUE valve in an adult with complex congenital heart disease, and a study of neighborhood deprivation as a predictor of neurodevelopmental follow-up.
- Brain injury in congenital heart disease: pathophysiology, MRI patterns, and perioperative risk factors
- Seeking Clues to Problems in Tiny Hearts
- The Evolving Frontier of Repeat Transcatheter Valve-in-Valve Mitral Interventions in Small Children
- Transcatheter Tricuspid Valve Replacement for Torrential Tricuspid Regurgitation in Complex Adult Congenital Heart Disease
- Area deprivation index as a predictor of neurodevelopmental follow-up in children with CHD
Tags: #PATIENT #PROVIDER
Also Worth Noting
Yale’s Health Care Affordability Lab added 10 proposals to its 1% Steps project, which now lists 23 policies it estimates would save about $450 billion a year (Becker’s, HealthExec). A KFF data note finds health care costs top Americans’ financial worries, with 27% very worried about affording them. And SCAI joined national physician groups in asking DHS for a permanent national-interest exemption for physicians and dentists as the department weighs a $103,265 fee on certain H-1B petitions.
Tags: #ALL