Weekly Spotlight
Medicare Rewrites the TAVR Standard, and Opens a Second One
Medicare’s national coverage rules for transcatheter aortic valve replacement changed materially on Sept. 10, and the change runs in two directions at once. In its final decision memo CMS removed coverage with evidence development for symptomatic severe aortic stenosis — the population TAVR has been covered for — and extended coverage, with CED, to asymptomatic severe aortic stenosis. That is not a loosening of an existing benefit. It is an expansion into a patient population Medicare did not previously cover for this procedure.
The access rules moved too. Heart-team evaluation may now be asynchronous, with a single in-person operator assessment. Operator volume thresholds drop to 20 transcatheter valve procedures a year, 15 of them TAVR, or 40 and 30 over two years, and two-operator participation becomes optional. Becker’s Hospital Review reads the memo as a rewrite of pre-procedural assessment, intraoperative requirements and the volume thresholds that decide which centers may offer TAVR at all. What did not move: facilities still need an on-site structural heart and cardiac surgery program, an experienced post-procedure ICU and a continuous quality improvement process, and CED studies must now meet AHRQ’s 17-point standards.
MedTech Dive reports that analysts expect the asymptomatic expansion to benefit Edwards Lifesciences in particular. Three leading cardiovascular societies have issued a joint statement with early reactions to the new policy.
The second direction is the one that got less attention. The same day it closed the aortic stenosis reconsideration, CMS posted a new tracking sheet opening a separate national coverage analysis for TAVR in aortic regurgitation. Aortic regurgitation is a distinct indication from aortic stenosis and has no national coverage today. A tracking sheet is the procedural first step toward one.
Tags: #ALL
From the Blog
No Lead Bird
Medicare’s fee schedule is named for relativity. Nothing in it ever checks whether relativity holds.
The Resource-Based Relative Value Scale rests on a principle that no part of the valuation process enforces. Testing it would mean holding all 6,671 services in the Physician Fee Schedule in mind at once, so the process substitutes what is performable: one service at a time, against comparators someone selects. The schedule has drifted toward the one thing it can measure — time alone now explains 81 percent of the variation in work values.
In 1987 Craig Reynolds showed that a flock needs no leader, no plan, and no bird that can see the whole flock. A service’s position has to come from the work itself and never from the value assigned to it, because the assigned value is the thing being tested. There is no anchor, and there cannot be one. In flocking there is no lead bird.
Courtney Yohe Savage, MPP · Savage Health Policy, LLC
Read the full blog post here. SHP filed comments on September 9, answering the Request for Information in the calendar year 2027 Physician Fee Schedule proposed rule on objective alternatives to the current committee processes.
Centers for Medicare and Medicaid Services (CMS)
Cardiology’s Mandatory Heart Failure Payment Model Arrives Jan. 1, 2027
CMS launches the mandatory Ambulatory Specialty Model on Jan. 1, 2027, moving cardiology beyond MIPS into a required value-based payment model built around heart failure care. Becker’s sets out four takeaways for cardiology programs preparing for the change.
Tags: #PROVIDER #HOSPITAL #PAYER
Medicaid Roundup: Work Requirements Take Shape as Cuts Reach the Care Line
CMS has begun filling in how Medicaid work requirements will actually run, and the 2025 reconciliation law’s Medicaid provisions are already reaching the care line. New guidance gives states a three-tiered option for determining medical frailty, with congestive heart failure in the past year an automatic qualifier for exemption and other conditions requiring additional context; advocates warn the added complexity could cost eligible patients their coverage. Analyses released this week put numbers on the rest: 17 states stand to lose 10% to 25% of total annual Medicaid dollars under the state-directed payment caps, millions of young adults could lose coverage once requirements take effect next year, and rural communities carry a disproportionate share of the reporting burden.
- Medicaid will let states use ‘tiers’ to determine medical frailty CMS Details Three-Tiered Option For States To Make Medically Frail Determinations
- Tracking Implementation of the 2025 Reconciliation Law: Medicaid Work Requirements Data and Policies
- New Policy Brief: Rural Communities at Greater Risk of Harmful Impacts from New Medicaid Work Reporting Requirements
- How Medicaid work requirements could impact young adults
- OBBBA’s State-Directed Payment Caps Will Trim Some States’ Medicaid Spend By A Quarter: Study
- ‘Aggressive’ Medicaid crackdowns will hurt children with autism, providers warn
- Half of U.S. hospitals lack maternity wards as Medicaid cuts loom: report
Tags: #PATIENT #PROVIDER #PAYER
Administration Will Mail $500 ACA Refund Checks Weeks Before the Midterms
The administration will begin mailing $500 checks next month to about 1 million unsubsidized healthcare.gov enrollees across 30 states, refunding what it calls overcharges from federal exchange user fees collected under the prior administration. The payments redirect roughly $500 million of exchange user-fee revenue, an unusual direct-to-consumer use of marketplace operating funds, and are timed to land before the Nov. 3 midterms. Recipients are concentrated in swing states. STAT reports that the legal authority for the payments is unclear and that the criteria deciding who receives one have not been spelled out, leaving open whether user-fee revenue can be returned directly to enrollees at all.
Axios STAT (subscription) Becker’s Hospital Review Inside Health Policy
Tags: #PATIENT #PAYER
The $50 Billion Rural Health Transformation Program Is Landing Unevenly
The $50 billion Rural Health Transformation Program, established under HR 1 to offset roughly $1 trillion in Medicaid cuts, is reaching states at very different speeds. CMS administers the program and will distribute $10 billion a year to all 50 states from 2026 through 2030. Hospital leaders say the money is already falling short of what rural providers need, which makes the state-by-state deployment picture the thing to watch.
- The GOP’s $50 Billion Rural Health Fund Is Coming Up Short, Hospital Leaders Say (subscription)
- Rural Health Transformation Program funding status, by state
Tags: #HOSPITAL #PAYER #PATIENT
Hospital Price Transparency Compliance Hits a Record High and Still Falls Short of Half
Just 49.4% of the hospitals reviewed are in full compliance with federal hospital price transparency rules, according to Patient Rights Advocate’s eighth annual report. That is a record high, and it means more than half of the hospitals reviewed are still not fully compliant. The gain comes amid stepped-up federal enforcement, and the remaining gap keeps pressure on CMS to escalate further.
Tags: #HOSPITAL #PATIENT #PAYER
Medicare’s Money Problems: Trust Fund Pressure, Unused Organs, and Thinner Advantage Benefits
Four pressure points on the same Medicare balance sheet surfaced in a single week. MedPAC flagged depletion of the Hospital Insurance Trust Fund in as few as seven years even as long-term Part A spending per beneficiary falls, while CBO puts insolvency 14 years out. The HHS Office of Inspector General reported that Medicare paid certified transplant centers an estimated $380 million over six years for organs that were never transplanted into Medicare enrollees, a nationwide projection from a 180-organ sample rather than an audited total, and traced the loss to conflicting CMS guidance and federal statutory requirements. CMS concurred with recovering $154,210 tied to five organs that two centers could not document, but neither concurred nor nonconcurred with OIG’s recommendation to revise the guidance so that only organs actually transplanted into Medicare enrollees count as Medicare usable organs, asking instead for further public comment on alternative methodologies. Medicare Advantage insurers, meanwhile, are cutting benefits and exiting markets for 2027, and CMS’s draft 2027 star ratings make half the rating thresholds harder to reach, tightening the quality bonus payments that finance those supplemental benefits.
- MedPAC examines Medicare spending shifts and hospital payment pressures
- Conflicting CMS Guidance and Federal Statutory Requirements Cost Medicare $380 Million Over a 6-Year Period for Organs Not Transplanted Into Medicare Enrollees
- Medicare Advantage Plans Appear To Be Cutting Benefits In 2027
- Half of Medicare Advantage stars thresholds harder to reach in 2027
Tags: #PAYER #HOSPITAL #PATIENT
Medicare Drug Spending Outlook Worsens as MFN Deals Draw Scrutiny
Two reports this week complicate the outlook for where Medicare drug dollars are going. New signs indicate the Inflation Reduction Act’s Part D benefit redesign is driving program spending up sharply, worsening the cost outlook for the drug benefit. A separate analysis finds the administration’s confidential most-favored-nation pricing deals with more than two dozen drugmakers may cut projected Medicare drug-cost savings by as much as 80%.
- Medicare Drug Coverage Faces An Ominous Spending Outlook
- Trump’s Secretive Pharma Deals May Undermine ‘Most-Favored Nation’ Pricing, An Analysis Suggests (subscription)
Tags: #DRUG #PAYER #PATIENT
CMS Pushes Clinical AI Forward While Its Own AI Prior-Auth Pilot Stumbles
CMS is moving clinical AI from pilot to program faster than the AI program it already runs is performing. Deputy Administrator Stephanie Carlton laid out the agency’s clinical-AI priorities alongside FDA officials at a CTA event in Washington, where clinicians pushed back on the pace and pressed on safety, validation and liability. Internal documents show the agency’s Medicare AI prior-authorization pilot, WISeR, facing contractor readiness gaps, decision delays and high non-affirmation rates, with providers reporting patients stuck waiting for care and payment problems.
- At CTA event, federal officials outline AI ambitions as clinicians debate risks
- Backlogs, Testing Gaps in Medicare AI Prior Auth Pilot (subscription)
Tags: #PROVIDER #HOSPITAL #DEVICE
Also in CMS
Several states have finalized 2027 ACA rates against a median requested increase of 15%, with some regulators pushing back on insurer requests and others accepting them ahead of Nov. 1 open enrollment, and the White House is separately reviewing a moratorium on new agent and broker registrations for plan year 2027 that would narrow the enrollment channels healthcare.gov consumers use after a year of broker-fraud enforcement. On the oversight side, EMTALA citations have climbed to the highest rate in more than a decade, according to a Becker’s analysis of CMS inspection data. CMS opens a Medicare Part D 340B claims data repository for voluntary submissions Oct. 1, the first test of whether claims-level data can stop duplicate discounts between the 340B program and the Part D inflation rebates. A revised national coverage determination now lets physician assistants and advanced practice nurses order every noninvasive colorectal cancer screening test Medicare covers, ending a long-standing physician-only ordering requirement. CMS’s proposed 2027 Physician Fee Schedule rule opens a two-year strategy aimed at the longstanding undervaluation of Medicare primary care payment, with an agency leader signaling larger reimbursement updates to follow.
Tags: #ALL
Food and Drug Administration (FDA)
FDA Fills Four Senior Posts and Creates Its First AI Deputy Commissioner
HHS named four senior FDA leaders, converting acting appointments into permanent ones. Michael Davis becomes permanent director of the Center for Drug Evaluation and Research and Karim Mikhail permanent director of the Center for Biologics Evaluation and Research; the same announcement filled the tobacco center directorship. FDA also created a Deputy Commissioner for Technology and Artificial Intelligence, its first, and named Jared Seehafer, a senior adviser who helped craft the agency’s white paper on generative AI-driven device regulation. The appointments end nearly two years of turnover in FDA’s top drug and biologics ranks and land while Heidi Overton’s nomination to lead the agency awaits confirmation.
Inside Health Policy STAT (subscription) Becker’s Hospital Review Fierce Pharma MedPage Today BioPharma Dive The Hill
Tags: #DRUG #DEVICE #PROVIDER
Two-Thirds of 2024’s New Drug Approvals Rested on a Single Study
More than two-thirds of the new drugs FDA approved in 2024 cleared the agency on a single study, according to a Stanford analysis published in PLOS One. The number of studies supporting FDA approvals has declined steadily since 2016. Over the same period industry sponsorship of supporting trials rose, NIH sponsorship fell, and public reporting of results was delayed. The analysis is a direct challenge to the agency’s current evidentiary bar and feeds the live argument over how much evidence FDA should require before a product reaches the market.
Tags: #DRUG #PROVIDER #PATIENT
FDA Sketches How It Would Regulate Generative AI in Care
FDA is sketching how it would regulate generative AI in care: benchmark systems by risk, measure their performance against clinicians, then monitor them postmarket. The agency met with Amazon on the company’s new large language model benchmark for patient-facing health AI agents.
Tags: #DEVICE #PROVIDER
Also in FDA
FDA published a Federal Register notice on medical device tracking, and cleared updates to an end-to-end cardiac imaging platform that uses a 360-degree ultrasound catheter to build real-time 2D and 3D maps of the heart, adding visualization and navigation capability for catheter-based procedures. On personnel, Angelo de Claro, the new head of FDA’s Oncology Center of Excellence, used his first interview since succeeding Richard Pazdur to set a regulatory agenda built on organizational stability and continued review modernization, and BioCentury published a profile of new CDER director Michael Davis (subscription). And FDA continues to maintain there is no shortage of estrogen patches for menopause even as ASHP data show nearly 20 formulations affected.
Tags: #ALL
Department of Health and Human Services (HHS)
Washington Puts Federal Money Behind Autonomous Clinical AI
ARPA-H is committing $62.7 million over four years to ADVOCATE, a program to build the first FDA-authorized agentic AI system for cardiovascular care — partially autonomous tools that assess heart failure symptom severity, prescribe drugs and order labs. Six teams hold contracts with up to $33.7 million obligated in year one, and the named awardees include Kaiser, Duke, Tempus AI and Updoc. ARPA-H says it is working closely with FDA to establish a regulatory framework for this class of clinical AI, and the award lands as federal health agencies move quickly to deploy AI agents that offer therapy and prescribe medicine, a pace that has raised safety concerns and questions about venture-capital influence on the rollout.
- Kaiser, Duke tapped for ARPA-H’s $62.7M autonomous AI bid STAT (subscription) Fierce Healthcare MedTech Dive
- U.S. Health Officials Move Quickly to Deploy Medical A.I. Despite Concerns
- Can AI save rural health care? (subscription)
Tags: #DEVICE #PROVIDER #PATIENT
CDC in Flux: Reorganization, Vaccine Guidance and a Silent Director
CDC reorganized the National Center for Immunization and Respiratory Diseases, consolidating offices, retitling divisions and branches and rewriting mission and function statements. As part of the restructuring the agency is merging its Influenza Division with its Coronavirus and Other Respiratory Diseases Division into a single Influenza and Respiratory Viruses Division. Director Erica Schwartz has drawn scrutiny for an unusual public silence a month into her tenure, leaving muddled guidance on COVID-19, flu and RSV vaccines as respiratory virus season opens during the worst measles epidemic in 30 years.
- Reorganization of the National Center for Immunization and Respiratory Diseases
- CDC Merges Its Flu, COVID Divisions To ‘Strengthen Operational Efficiency’
- The CDC Division I Spent 15 Years Building Is in Peril
- CDC director’s ‘unusual’ silence draws scrutiny
- The Vaccine Recommendations Are Out. Now Comes the Hard Part.
Tags: #PROVIDER #PATIENT #PAYER
NIH Research Money Heads Toward the Pentagon
Democratic lawmakers are objecting to an agreement that would let the Defense Department tap billions of dollars appropriated for NIH, and physicians have raised alarms about the same plan. NIAID’s new strategic plan shifts the institute away from pandemic preparedness and emerging infectious diseases toward HHS Secretary Kennedy’s priorities such as immune system dysfunction, as NIH finalizes the DOD partnership. In the same week NIH opened public comment on a proposed biosafety policy that would replace its current oversight framework for research involving biohazards.
- Docs Alarmed by NIH Plan to Redirect Medical Research $$ to Pentagon
- Lawmakers Criticize Deal That Would Send NIH Funds To Department Of Defense
- NIAID Strategic Plan Omits Emerging Diseases As NIH, DOD Finalize Partnership
- Draft NIH Biosafety Policy for Research Involving Biohazards
Tags: #PROVIDER #PATIENT
Also in HHS
HHS’s Office of Minority Health terminated 16 grants worth $38 million over four years, more than half its active awards, with termination letters going to county and community grantees Aug. 25. The cancelled work included infant mortality, postpartum home visiting and cancer screening, and the money is being redirected toward administration priorities of infertility and exercise. On the spending side, HHS awarded $383.4 million in behavioral health and crisis-response grants, $252 million of it for the 988 Suicide and Crisis Lifeline, suicide prevention and mobile crisis services, and the first awards under a new Rural Hospital Provider Assistance Program sent nearly $25 million to 132 small rural hospitals in 13 states to retain clinicians and keep essential service lines from closing. In enforcement, the Labor Department now treats covering telehealth for medical but not behavioral care as a red flag under the Mental Health Parity and Addiction Equity Act, giving plans a concrete test of how the administration will police network and plan design.
Tags: #ALL
Heard on the Hill
No Surprises Act Arbitration Draws a Coalition, a Congressional Probe and a Cost Fight
The No Surprises Act’s arbitration system came under pressure from three directions in a single week. A coalition of 67 consumer, labor, patient and employer groups led by Families USA asked congressional leaders to overhaul the independent dispute resolution process that sets out-of-network payment amounts, arguing that private-equity-backed provider groups are gaming arbitration and driving up premiums. Rep. Frank Pallone opened an oversight investigation into the arbiters themselves, and a separate commentary disputes the $22 billion price tag that has framed the cost debate.
- Congress Urged To Overhaul No Surprises Act By Unions, Employers Consumer, Employer Groups Press Congress To Rein In No Surprises Act Arbitration Amid Renewed Scrutiny From Lawmakers Employer, consumer groups urge lawmakers to reform No Surprises Act’s IDR
- Top Democrat investigates No Surprises arbiters
- No, the No Surprises Act Didn’t Cost $22 Billion
Tags: #HOSPITAL #PAYER #PROVIDER
Congress’s Year-End Health Agenda Takes Shape
Congress has left nearly every significant health proposal unfinished this year apart from PBM provisions, concentrating expiring-program extensions and other health measures into a December deadline cluster that is now the only realistic vehicle. Three items lined up behind that deadline this week: a bipartisan MACRA reform package headlining an Energy and Commerce health subcommittee hearing, Medicaid funding for 9-8-8 mobile crisis teams, and student-loan relief for residents and interns. Behavioral health advocates warn that no other legislative vehicle is likely before 2027.
- Congress Faces Key Healthcare Legislation Deadlines In December
- E&C Health Panel To Discuss Bipartisan MACRA Reform Package, Other Medicare Pay Reform Bills
- Behavioral Health Advocates Push Congress To Renew Mobile Crisis Funding
- Cardiologists, heart surgeons support push to make postgraduate medical training more affordable
Tags: #ALL
Notable Notes
Cardiovascular Evidence Roundup: Heart Failure Around TAVR, Congenital Valve Reintervention and Risk Prediction
New data show most TAVR patients carry a history of heart failure and many are not prescribed the guideline-recommended heart failure medications, pointing to a gap in medical management around the procedure. Two congenital items build out the evidence base for reintervention: a cost-effectiveness model weighing transcatheter against surgical pulmonary valve replacement in patients with prior right ventricular outflow tract surgery, and a Society of Thoracic Surgeons Adult Cardiac Surgery Database analysis that develops a mortality risk model for adult congenital cardiac reoperations. The American Heart Association’s PREVENT cardiovascular risk equations are now integrated into Epic’s electronic health record platform, putting the newer risk model in front of clinicians on a national EHR footprint.
- Heart failure before and after TAVR: New data point to ongoing concerns
- Surgical and transcatheter pulmonary valve replacement in patients with congenital heart disease, who have a history of right ventricular outflow tract remodeling, Indonesia
- Risk Model for Adult Congenital Cardiac Reoperations: Analysis of the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD)
- American Heart Association PREVENT equations now integrated into national electronic health record platform
Tags: #DEVICE #PROVIDER #PATIENT
Who Is Losing Coverage, and Who Is Struggling Most
One question — who is losing coverage, and who is faring worst — drew three answers this week. KFF CEO Drew Altman previewed findings from a 25,000-person KFF survey identifying the chronically ill uninsured as the group struggling most in U.S. health care. Georgetown’s Center for Children and Families reports that Medicaid and CHIP enrollment has fallen by 2.4 million since January 2025, and the Census Bureau’s first full national read on 2025 income, poverty and health insurance arrives next week.
- The Group that Struggles the Most in American Health Care
- The Trump Administration’s Latest War On Vulnerable Children
- What to Watch for in Next Week’s Release of Census Data on Income, Poverty, and Health Insurance in 2025
Tags: #PATIENT #PAYER
Hospital Prices, Mergers and a State Spending Cap
Three moves this week bear on who restrains hospital prices. The American Hospital Association, citing a newly commissioned Kaufman Hall report, urged antitrust regulators to weigh factors beyond commercial insurance prices when reviewing hospital merger proposals, including risks to vulnerable patients and facilities. California moved on prices directly, adopting a 3.5% annual hospital spending growth cap through 2029 with penalties for hospitals, physician groups and insurers that exceed it.
- AHA to regulators: Look beyond commercial prices when weighing hospital mergers Hospital consolidation policy must look beyond commercial insurance prices: AHA
- The state putting a 3.5% spending growth cap on hospitals
- Op-ed: Our healthcare affordability crisis is a structural problem. We need structural solutions
Tags: #HOSPITAL #PAYER #PATIENT
Also Worth Noting
The AMA released its 2027 CPT code set with 299 new codes, 10 of them for clinical AI, plus 74 revisions and 80 deletions, all effective Jan. 1. On maternal health, Healthy Moms, Healthy Babies America — a bipartisan campaign founded by philanthropists Olivia and Tom Walton — pledged $100 million over five years toward cutting the U.S. maternal mortality rate in half. On the workforce, an opinion piece argues that the physician shortage is deepening, noting that more than 83 million Americans already lack adequate access to a doctor, and calls for sustained policy attention to the training pipeline.
Tags: #ALL
Regulatory and Public Comment Intelligence
Comment dockets on the major payment rules run to tens of thousands of letters, and most of that record never gets read by the people it affects. Savage Health Policy reads it end to end. Every comment is coded argument by argument against a frame built from the rule’s own proposals and requests for comment. Form-letter campaigns are collapsed to a single coded template with a signatory count, so volume never passes for consensus. Every source document, quote and page number is verified.
The rule summary — the whole regulation read end to end and summarized section by section — is free. Paid work starts at $4,500 and runs through a docket read delivered as a workbook you can filter by filer, filer type, topic, position and argument, up to a position read that codes your own letter against the record and returns a scorecard when the final rule publishes: what the agency adopted, and whose language it tracked.
Hospital Outpatient Prospective Payment System · Hospital Inpatient Prospective Payment System · Physician Fee Schedule · ad hoc rulemaking including national coverage determinations, requests for information and model rules.
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