CMS proposed the most significant expansion of Medicare TAVR coverage since the program launched, moving to extend access to asymptomatic patients and revise the volume requirements that have governed structural heart programs since 2012.
Weekly Spotlight
CMS Proposes Sweeping TAVR Coverage Expansion, Including Medicare Access for Asymptomatic Patients
CMS released its proposed decision memo on the TAVR national coverage determination this week, opening a public comment period on a proposal that would extend Medicare coverage to asymptomatic patients with severe aortic stenosis — a population currently excluded — and revise the facility and operator volume requirements governing program eligibility since 2012.
The asymptomatic coverage extension alone could dramatically expand the eligible patient population. Clinical guidelines have increasingly supported earlier intervention before symptoms develop, and the NCD has long been criticized for lagging behind the evidence base. The volume requirement revisions address a parallel critique: that the 2012 thresholds no longer reflect the current state of the procedure or the geographic distribution of structural heart programs.
Clinician and advocacy response was immediate. Leading cardiologists and cardiac surgeons welcomed the asymptomatic coverage proposal while flagging questions about how revised volume thresholds will be operationalized and whether smaller community programs will be protected. The Alliance for Aging Research urged the Trump administration to move forward, framing the current NCD as “getting in between patients and their doctors.” Real-world redo TAVR outcome data published this week adds to the clinical context, with positive results for valve-in-valve procedures following prior balloon-expandable valve implantation — a growing clinical population as the first generation of TAVR patients ages.
For Edwards Lifesciences, the proposal represents the culmination of years of CMS engagement. The Sapien platform’s clinical data in low- and intermediate-risk patients — accumulated across the PARTNER trial series — has progressively built the case for broader access. The asymptomatic indication reflects both the maturation of the evidence base and the procedural refinements that have made TAVR viable in lower-risk populations. Public comments are due 30 days from publication.
Source(s):
CMS — NCA Tracking Sheet
Cardiovascular Business
Cardiovascular Business — Clinician Feedback
Cardiovascular Business — Alliance for Aging Research
Cardiovascular Business — Redo TAVR Outcomes
Tags: #DEVICE #PAYER #PROVIDER
Centers for Medicare and Medicaid Services (CMS)
Medicaid Roundup: Work Requirements Final Rules, MACPAC Report, MA Stars, Substance Use Coverage
Work Requirements: Final Rules Out, Implementation Questions Mount
The Trump administration issued final Medicaid work requirement rules establishing the framework states must follow to verify that enrollees document 80 hours per month of qualifying activity beginning January 2027. KFF launched a suite of tracking resources. Georgetown’s Center on Children and Families critiqued the documentation burden as practically unworkable; the Center on Budget and Policy Priorities found the administration’s underlying analysis deeply flawed, projecting coverage losses well beyond CMS’s acknowledgment.
Source(s): KFF Health News · KFF Tracker · Georgetown CCF · Center on Budget and Policy Priorities
MACPAC June 2026 Report: Community Engagement, Prior Authorization, Program Integrity
MACPAC’s June 2026 Report to Congress covers community engagement requirements in Medicaid, prior authorization automation standards, and program integrity oversight — including recommendations to CMS on improving oversight of state-reported expenditures, echoing a concurrent OIG finding.
Source(s): MACPAC
CMS Ignores Law on Substance Use Disorder Coverage
Georgetown’s Center on Children and Families argues CMS violated federal law in a recent proposed rule that would allow states to deny Medicaid coverage to individuals with substance use disorders who do not meet work reporting requirements — a population Congress explicitly protected in OBBBA.
Source(s): Georgetown CCF
Tags: #PATIENT #PAYER
CMS Recalculates Medicare Advantage Star Ratings After Clover Lawsuit
CMS is voluntarily recalculating 2027 Medicare Advantage quality bonus payment ratings following a court ruling that the agency unlawfully included certain quality measures in its prior methodology. Plans receive the higher of their original or recalculated rating, limiting financial downside but adding volatility to a program already under pressure. Health Management Associates notes the ruling signals that MA plans should engage in formal scenario planning around star ratings methodology risk.
Source(s):
STAT News
Becker’s Hospital Review
Health Management Associates
Tags: #PAYER
Medicare GLP-1 Bridge Program Launches July 1; Drug Pricing Proposed Rule Adds Subcutaneous Loophole Fix
The Medicare GLP-1 Bridge program begins July 1, offering Wegovy and Zepbound at $50 per month to eligible Part D enrollees through December 2027 — with costs falling to taxpayers outside standard Part D. In related drug pricing action, CMS has proposed closing a separate loophole allowing manufacturers to reformulate drugs into subcutaneous versions to reset Medicare negotiation timelines, a companion to last week’s proposed permanent negotiation framework.
Source(s):
The Hill
STAT News — Pharmalittle
STAT News — Drug Negotiation Loophole
Tags: #PAYER #DRUG
Oz and AMA at Odds Over Autonomous AI in Clinical Settings
CMS Administrator Mehmet Oz urged the AMA to embrace autonomous and semi-autonomous AI in clinical settings, arguing AI’s potential to expand access justifies reduced physician oversight. The AMA pushed back, maintaining that autonomous AI tools lack the judgment required for individual coverage and care decisions. The exchange reflects a widening governance divide as both CMS and FDA move toward expanded AI deployment.
Source(s):
InsideHealthPolicy
Tags: #ALL
MedPAC June Report: Raise Physician Pay, Reduce Post-Acute Rates
MedPAC’s June 2026 report to Congress recommends indexing the Medicare physician fee schedule to medical inflation while reducing payment rates for inpatient rehabilitation facilities, skilled nursing facilities, and home health agencies, which the commission found are being overpaid relative to costs. The report flags Medicare Advantage enrollment and spending growth as contributing factors to the projected 2033 Hospital Insurance Fund insolvency date.
Source(s):
MedPage Today
Tags: #PAYER #PROVIDER #HOSPITAL
Food and Drug Administration (FDA)
FDA Advisory Panel Unanimously Endorses Moderna’s mRNA Flu Vaccine
FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to endorse Moderna’s mRNA seasonal flu vaccine — the first mRNA flu shot to reach this stage — despite HHS Secretary Kennedy’s prior opposition to the mRNA platform. FDA staff had raised data completeness concerns ahead of the meeting; the unanimous vote signals the panel found the evidence sufficient. Final FDA approval is the next step.
Source(s):
STAT News
InsideHealthPolicy
Tags: #DRUG #PATIENT
FDA Approves First Generic Single-Dose Flu Antiviral; Colorado Drug Importation Gets Green Light
FDA approved the first generic version of baloxavir marboxil (Xofluza) as a single-dose flu treatment, expanding access ahead of the 2026-27 flu season. Separately, FDA approved Colorado’s plan to import lower-cost prescription drugs from Canada — making it the second state after Florida to receive approval, though Florida has yet to begin importing. Colorado faces significant implementation hurdles including supplier agreements and safety verification.
Source(s):
MedPage Today
STAT News — Colorado
Fierce Pharma
Tags: #DRUG #PATIENT
FDA’s New Bayesian Guidance Could Reshape Device and Drug Trial Design
FDA released guidance on Bayesian statistical methods in clinical trials, potentially lowering evidence thresholds for certain device and drug approvals by allowing prior data to inform trial design more formally. MedCity News characterizes the guidance as quietly reshaping how manufacturers approach evidence generation for complex products.
Source(s):
MedCity News
Tags: #DEVICE #DRUG
State Medical Boards and FSMB Engage FDA on AI Prescribing Regulation
Utah’s medical board, Utah’s AI office, and the Federation of State Medical Boards are in active conversations with FDA as the agency navigates a regulatory dispute over AI prescribing authority. The engagement reflects growing state-level pressure on FDA to clarify its framework for autonomous AI systems in clinical prescribing ahead of any formal federal rulemaking.
Source(s):
InsideHealthPolicy
Tags: #PROVIDER #DRUG
Department of Health and Human Services (HHS)
RFK Jr.: $700M Mental Health Investment, Senate Vaccine Probe, and a Military Flu Outbreak
Three HHS developments converged this week. Kennedy announced $700 million in behavioral health funding emphasizing faith-based models — STAT News found most of the money to be a reallocation of existing SAMHSA appropriations. Senate Democrats launched a formal investigation into Kennedy’s changes to federal vaccine policy, requesting records on the ACIP restructuring. And more than 160 troops contracted influenza at Lackland Air Force Base after Defense Secretary Hegseth lifted the military influenza vaccination order — a direct policy consequence receiving national attention.
Source(s):
STAT News
The Hill — Senate Probe
The Hill — Troops
Tags: #ALL
ACIP Legal Fight Moves to Accelerated Appellate Schedule
The DOJ is seeking expedited appellate proceedings in the medical societies’ lawsuit challenging HHS’s restructuring of the Advisory Committee on Immunization Practices. The AAP pushed back directly on Kennedy’s claim that a “lawful ACIP” cannot meet ahead of the fall flu season, arguing the committee can convene at any time and that Kennedy’s framing is legally unsupported.
Source(s):
InsideHealthPolicy
InsideHealthPolicy
Tags: #ALL
Trump Administration Narrows CDC’s Global Health Role; 95% of CDC Staff Say Restructuring Will Cost Lives
The Trump administration is moving forward with plans to significantly scale back CDC’s role in global disease surveillance and outbreak response, with changes expected to take effect in October. A Michigan State University survey of 624 current and former CDC employees found 95% believe recent restructuring will cost American lives — a level of internal dissent without recent precedent at a federal public health agency.
Source(s):
KFF Health News
Becker’s Hospital Review
Tags: #ALL
340B: Eli Lilly Terminates Discounts; Hospitals Demand Congressional Action
Eli Lilly followed through on its ultimatum, terminating 340B drug discounts to hospitals that had not submitted claims-level data under its reporting policy — affecting a few dozen hospitals according to STAT News. Hospital associations immediately called on Congress to force HHS to intervene. A Federal Register notice the same week addressed a related 340B rebate model pilot program, adding a parallel policy thread.
Source(s):
STAT News
InsideHealthPolicy
Federal Register
Tags: #DRUG #HOSPITAL
HHS Siphons $96M From SAMHSA Appropriations for New STREETS Program
HHS redirected $96 million from four congressionally appropriated SAMHSA grant programs to fund STREETS, a new initiative focused on homelessness and addiction. The reallocation drew criticism from public health advocates who argue the diversion undermines congressional intent and reduces capacity in programs serving different populations.
Source(s):
InsideHealthPolicy
Tags: #PATIENT #PAYER
MAHA Meets K Street: Lobbyists Still Decoding the Kennedy Agenda
A year and a half into the administration, health care lobbyists remain uncertain how to engage with Kennedy’s Make America Healthy Again agenda. POLITICO Pulse reports that veteran K Street operatives describe the MAHA framework as ideologically coherent but practically difficult to operationalize in standard regulatory or legislative channels — creating unusual lobbying dynamics for industries ranging from food and agriculture to pharmaceutical.
Source(s):
POLITICO Pulse
Tags: #ALL
FY27 HHS Budget Proposal: Rural Health Gains, CDC Cuts
The FY2027 HHS budget proposal decreases overall discretionary HHS funding by close to 4% from current appropriations while directing additional resources to rural health programs. CDC faces targeted cuts. HFMA notes the proposal reflects administration midterm priorities — rural health as a visible win, public health infrastructure as a cost-reduction target.
Source(s):
HFMA
Tags: #ALL
VA Redesignates LGBTQ+ Care Coordinators Under Gender Ideology Memo
VA officials were given 14 days to comply with a June 12 memo redesignating LGBTQ+ care coordinators and limiting services characterized as “gender ideology” under executive order. The action eliminates a VA care coordination structure expanded in recent years to address documented disparities in veteran health outcomes.
Source(s):
Government Executive
Tags: #ALL
Federal Grant Delays Threaten Disability Services and Health Equity Research
Federal grant delays are threatening essential disability research programs and the organizations that depend on them, with researchers reporting uncertainty about institutional viability. Separately, a White House proposal to define “health equity” research narrowly could disqualify substantial portions of existing federal health disparities funding — with researchers describing the potential scrutiny as unprecedented in scope.
Source(s):
STAT News — Disability
STAT News — Health Equity
Tags: #ALL
FTC and State AGs Sue WPATH Over Pediatric Gender Care Standards
The FTC and attorneys general from four Republican-led states sued the World Professional Association for Transgender Health, alleging the organization made deceptive claims about the evidence base for pediatric gender-affirming care in its published standards. The suit marks the FTC’s first action targeting a medical professional association’s clinical guidance.
Source(s):
STAT News
InsideHealthPolicy
Tags: #PROVIDER #PATIENT
Large JAMA Study Links COVID-19 Vaccination to Reduced Cardiovascular Risk
A large JAMA study found recent COVID-19 vaccination was associated with significantly lower risk of heart attacks, strokes, and cardiovascular hospitalizations. The finding adds to the growing evidence base on cardiovascular benefits of COVID-19 vaccination and arrives as the administration continues to reshape the federal vaccine advisory infrastructure.
Source(s):
STAT News
Tags: #PATIENT #PROVIDER
Heard on the Hill
House GOP Races to Advance Reconciliation 3.0 Before Recess
House Republican leaders are targeting Wednesday for another senior-level reconciliation meeting as they attempt to move Reconciliation 3.0 forward with eight legislative days remaining before recess. The package is expected to include additional spending cuts and tax provisions beyond those in the first two reconciliation bills.
Source(s):
POLITICO
Tags: #ALL
Senate HELP Advances Biosimilar and Patent Bills to Floor; Generic Drug Bill Stalled
The Senate HELP Committee advanced a bill requiring FDA and the U.S. Patent and Trademark Office to coordinate more effectively on patent challenges to brand biologics, moving it to the Senate floor. The committee separately punted on a generic drug bill after a conservative group raised objections ahead of the markup.
Source(s):
InsideHealthPolicy
Tags: #DRUG
Senate Democrats Force Vote on Trump Administration ACA Payment Rule
Senate Democrats are using Congressional Review Act procedures to force a floor vote on the Trump administration’s ACA payment parameters rule, which they argue will raise out-of-pocket costs and hamper enrollment. The move is designed to create a midterm contrast on health care costs rather than to overturn the rule, given the vote is expected to fail.
Source(s):
MedPage Today
Tags: #PAYER #PATIENT
Senate Finance Democrats Solicit Input on Drug Pricing Policy Roadmap
Senate Finance Committee Ranking Member Ron Wyden and Democratic colleagues are soliciting stakeholder feedback on a suite of drug pricing proposals including IRA expansion, insulin pricing, and PBM reform — signaling the minority is building a legislative agenda for the post-midterm environment.
Source(s):
InsideHealthPolicy
Tags: #DRUG
Twenty-Three Senate Republicans Call for Section 301 Pharma Pricing Probe
Twenty-three Senate Republicans sent a letter urging the Trump administration to use Section 301 of the Trade Act to investigate foreign drug pricing practices they characterize as unfair trade — positioning signatories with the administration’s trade-oriented approach to drug pricing while sidestepping domestic regulatory action.
Source(s):
InsideHealthPolicy
Tags: #DRUG
Notable Notes
Poll: Nearly Half of Americans Say They Cannot Afford High-Quality Health Care
Only about half of U.S. adults could afford their health care and had access to quality care last year, according to a Commonwealth Fund survey — a five-year low in perceived affordability. The finding arrives as congressional debate intensifies over ACA premium subsidies, Medicaid cuts, and out-of-pocket cost regulations.
Source(s):
KFF Health News
The Hill
Tags: #PATIENT #PAYER