This week: CMS’s draft 2027 outpatient rule takes aim at 340B and site-neutral pay, Medicare’s GLP-1 coverage era begins, and the Medicaid work-requirement fight lands in court.
This week: the 340B drug discount program faces a reckoning from every direction — Eli Lilly’s hospital cutoffs, a Cassidy overhaul bill, litigation over the patient definition, and hospital associations calling for federal intervention, all arriving in the same week.
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.
A week defined by the Medicare Advantage prior authorization reckoning, the CMS drug negotiation permanence push, and a concentrated burst of TAVR clinical evidence from JACC:CI.
This week: CMS released a sweeping Medicaid work requirements rule that blindsided states, patient advocates, and health systems—reshaping a coverage landscape already under strain from record-low children’s enrollment.
This week: the No Surprises Act arbitration overhaul, a $775 billion Medicaid state-directed payments proposed rule, and a full cycle of TAVR clinical evidence.
The Trump administration’s FDA lost its second top official in four days this week, as CDER acting director Tracy Beth Høeg’s departure compounded the void left by Commissioner Marty Makary’s resignation and in a landmark ruling, the Supreme Court declined to revive the challenge to Medicare drug price negotiation, clearing a significant legal obstacle for the Inflation Reduction Act’s implementation.
This week the Department of Health and Human Services (HHS) launched Secretary Robert F. Kennedy Jr.’s antidepressant deprescribing campaign, House Oversight Chair James Comer pressed the Centers for Medicare and Medicaid Services (CMS) to explain whether Current Procedural Terminology (CPT) code complexity fuels improper billing, and the Food and Drug Administration (FDA) blocked publication of internal research finding COVID and shingles vaccines safe.
Nebraska launched HR 1 Medicaid work requirements ahead of the federal deadline as rural hospitals reported the cuts biting, the surgeon general nomination shifted again as President Trump replaced Casey Means with Nicole Saphier, and health system CEOs conceded openness to site-neutral payment reform at a Ways and Means hearing on hospital affordability.
This week’s biggest regulatory development was the joint CMS-FDA launch of the RAPID Coverage Pathway — a new fast-track mechanism for Medicare coverage of breakthrough devices — covered in depth in the Spotlight below, alongside a parallel IPPS proposal to repeal a key NTAP payment incentive for the same device category.
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