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.
This week delivered a marathon of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s first major congressional testimony, during which he confirmed an overhaul of the U.S. Preventive Services Task Force (USPSTF), an expansion of prior authorization into traditional Medicare, and plans to hire 12,000 new HHS employees. President Trump separately nominated former deputy surgeon general Erica Schwartz to lead the Centers for Disease Control and Prevention (CDC), a pick seen as a departure from earlier vaccine-skeptic signaling. Nebraska prepares to become the first state to enforce Medicaid work requirements on May 1, just as a Senate minority report documented that drugmakers raised prices on hundreds of medications despite signing voluntary most-favored-nation deals with the administration.
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