Healthcare Updates 06/01/2026

Written By Girish Kaimal

This week's federal pharmacy regulatory sweep covers 340B litigation, PBM legislation, and contract pharmacy enforcement — with strategic implications for covered entities and health systems

  • CVS sued for $250M in alleged 340B specialty spread diversion (May 21). Mount Sinai, U-Michigan, and U-Kansas filed parallel federal suits alleging CVS/Caremark/CVS Specialty/WellPartner systematically siphoned 340B savings via post-sale rate manipulation between 2020-2025. (Healthcare Dive | Frier Levitt complaint)

  • CVS sued Tennessee within hours of SB 2040 (FAIR Rx Act) signing (May 22). Tennessee bans PBM-pharmacy vertical integration effective July 1, 2028. National precedent following Arkansas; Warren-Hawley federal bill mirrors it. (Healthcare Dive | Tennessee Lookout)

  • 4th Circuit granted en banc rehearing of WV and MD 340B contract pharmacy cases (May 28). Most consequential 340B litigation event of the month. Original panel decisions had created the first federal appellate wins for drugmakers. (AHA | 340B Report)

  • Clover Health won APA challenge against CMS on 2026 MA star ratings (May 27). Federal judge ordered CMS to recalculate, finding 20 measures improperly included. Same legal theory (APA + nondelegation) that succeeded against the 340B Rebate Pilot. CareFirst BCBS has parallel suit pending. (Becker's | Modern Healthcare)

  • FDA approved Hepcludex (bulevirtide) — first US treatment for chronic HDV (May 22). Gilead specialty injectable, ~80K US patients, opens new ID/hepatology formulary line. (FDA | Gilead)

  • LEO Pharma became the 43rd manufacturer to announce 340B contract pharmacy restrictions (May 27, effective June 22). Targets Adbry (tralokinumab) — moderate-severe atopic dermatitis. (340B Report)

FDA Updates

  • Hepcludex (bulevirtide-gmod) approved (May 22) — first US HDV treatment; accelerated approval, boxed warning for HBV/HDV flare on discontinuation; SC daily injection. (FDA)

  • Imfinzi (durvalumab) + BCG approved for BCG-naïve high-risk NMIBC (May 28) — POTOMAC trial, HR 0.68 for DFS. Expands urology HOPD infusion volume. (FDA)

  • Datroway (datopotamab deruxtecan) approved for 1L mTNBC (May 22) — first targeted therapy with OS benefit in this setting. (FDA)

  • Draft guidance: reducing animal testing in cancer drug development (May 29) — continues FDA's push toward in-silico/organoid methods.

  • Final guidances released May 28-29: Q8/Q9/Q10 Q&A (R5); bioequivalence with PK endpoints for ANDAs; statistical approaches to BE.

  • Federal Register (May 26): Pulmonary-Allergy Drugs and Drug Safety/Risk Management Advisory Committees both renewed for 2 years. (Pulm-Allergy)

CMS Updates

  • IOTA Model Final Rule (this week) — 103 selected kidney transplant hospitals; 6-year mandatory CMMI model; downside risk begins 2026, capped at $2,000/transplant; upside $8K-$15K/transplant. Low-volume threshold raised from 11 to 15 transplants/year; VA/military excluded; MA beneficiaries now included in attribution. (CMS fact sheet)

  • No Surprises Act Federal IDR Operations Final Rule (joint HHS/Labor/Treasury/OPM, this week). Provider-favorable. Key changes: admin fee $115 → $15; batching cap 25 → 50 line items; payers must indicate IDR eligibility alongside initial payment; new IDR Registry for payer contact info; 15-day payer response requirement after negotiation start. 2025 baseline: providers initiated 99.9% of disputes, won 88%. (Modern Healthcare )

  • HHS AERO (Automated Enforcement and Review Operations) launched — AI-driven audit analysis covering 5+ years of federal program oversight data across all 50 states. Pairs with FDA's Elsa/HALO and the one-day inspection pilot as a structural federal AI-enforcement pattern.

  • White House Fraud Task Force update: 400+ high-risk hospice provider suspensions in LA; $91M Medicaid deferment for MN; $1.3B Medicaid withholding for CA

  • Continuing items: CMS-0062-P PA for Drugs proposed rule (comments close June 15); GLP-1 Bridge launches July 1; GLOBE/GUARD/GENEROUS final rules pending

Courts / SCOTUS

  • Clover Health v. HHS/CMS (May 27) — S.D. Ga., Judge Wood ordered CMS to recalculate 2026 star rating; 20 measures struck on APA grounds; ~$120M at stake for Clover; ruling timed before June 1 MA bid deadline. (Becker's)

  • 4th Circuit grants en banc rehearing of West Virginia and Maryland 340B contract pharmacy cases (May 28).

  • Hospital systems v. CVS (May 21) — three federal complaints, $250M alleged 340B specialty spread diversion. (Healthcare Dive)

Girish Kaimal