PDAB · MD
Maryland PDAB sets first state UPL frameworks on Farxiga + Jardiance + Ozempic + Trulicity
Why it matters: Cardiometabolic franchises are squarely in the PDAB crosshairs. Anchor pricing is the Medicare Maximum Fair Price (e.g., Ozempic framework uses 2027 MFP $274/30-day). Manufacturer market access teams need a state-by-state UPL playbook, not just federal IRA strategy.
PDAB · Multistate
PDAB landscape: 4 states with UPL authority (CO, MD, MN, WA); Virginia advances PDAB bill (SB 271)
Why it matters: Washington staff is recommending Maryland-style flexible UPL approach starting 2027. Litigation challenges are mounting — but the PDAB playbook is propagating faster than the lawsuits resolve.
340B · 4th Cir.
4th Circuit blocks West Virginia 340B contract pharmacy law — circuit split deepens
Why it matters: Conflicts with 5th + 8th Circuit rulings upholding similar Louisiana + Arkansas laws. AHA seeking en banc review. 22 states have enacted similar contract-pharmacy protections — the SCOTUS-bound circuit split is now active.
340B · DOJ
DOJ files amicus briefs supporting PhRMA in Rhode Island + Colorado 340B cases
Why it matters: Federal government now actively siding with manufacturers against state 340B contract pharmacy laws — material shift from prior administration position. Hawaii district court + Minnesota appellate decisions went the other way (upheld state law).
340B · WA
Washington's new 340B law (SB 5981) draws immediate legal fire from drugmakers
Why it matters: Washington became the first state to introduce a 340B contract-pharmacy access bill in 2026. Manufacturers are challenging in court before implementation — pattern repeats across the 22-state landscape.
PBM · VA
Virginia: HB 483 (Affordable Medicine Act) + SB 669 (PBM practices) signed
Why it matters: HB 483 adopts IRA Maximum Fair Prices for state-regulated plans — first state to formally import federal MFPs. SB 669 (effective Jul 1) bans electronic claim fees, claim reversal without notice, retroactive denials. PBM operating model in VA materially changed.
PBM · OH
Ohio HB 229 enacted: standalone PBM licensure framework (Chapter 3957)
Why it matters: Three new transparency obligations for PBMs: annual rebate accounting, plan sponsor access to financial + utilization data, full written disclosure of services agreements. Effective for contracts entered/renewed Jul 1, 2027 onward.
PBM · AR + MA + CO/CA
Arkansas bans PBM-owned pharmacies (HB 1150, enjoined); MA SB 3012 transparency; CO + CA "delinking" laws
Why it matters: All 50 states now regulate PBMs. Arkansas pushing the structural-divorce model (vertical integration ban). CO + CA delinking removes rebate-tied compensation. State PBM patchwork is now denser than the federal CAA 2026 reforms.
Prior Auth · CMS
CMS proposes extending Interoperability + Prior Authorization rule to drugs (CMS-0062-P)
Why it matters: Standard 24-hour decisions, expedited 72-hour for Medicaid + CHIP + MA. Mandatory ePA via NCPDP standards starting Oct 1, 2027. Operational lift for state Medicaid agencies is significant — manufacturer access teams should engage in the comment window.
Prior Auth · State
Gold card laws in 5 states (TX, LA, MI, VT, WV) — but pharmacy is largely carved out
Why it matters: Texas HB 3812 extends gold-card lookback from 6 months to 1 year (effective Sep 1, 2026). WV SB 833 explicitly removes prescription drugs from gold carding. Pharmacy-counter PA friction remains the unsolved policy gap — expect 2027 push to extend gold carding to drugs.
Step Therapy · NJ
New Jersey A1825 effective Jan 1, 2026 — guardrails on step therapy across state plans
Why it matters: Applies to Medicaid, State Health Benefits, and School Employees plans. Insurers must base protocols on independent peer-reviewed clinical guidelines — not internal cost-ranking. Rhode Island advancing similar exception expansion this session.
Vaccine · ACIP
CDC revises childhood + adolescent immunization schedule — state-by-state ripple begins
Why it matters: Many state school immunization laws auto-incorporate ACIP — federal changes flow through automatically. Changes also affect commercial insurance coverage mandates. Vaccine manufacturers (Merck, Pfizer, GSK, Sanofi, Moderna) need state-by-state impact mapping.
Vaccine · State
States diverging from ACIP: Colorado now incorporates AAFP + ACOG + ACP recommendations
Why it matters: States are building independent vaccine recommendation pathways anticipating further federal volatility. WV released a public resource clarifying federal-vs-state divergence. Vaccine market access is fragmenting — coverage + uptake will vary materially by state.
Federal · MFN
MFN sweep complete: 17 of 17 Big Pharma signed; Trump pivots to enforcement + downstream pricing flow
Why it matters: 86% of branded market now under MFN terms. State Medicaid programs need updated pricing + supplemental rebate strategy. Congress is demanding agreement copies — expect state AG follow-on.
Federal · CMS
IPAY 2026 negotiated drug prices live; Third negotiation cycle (15 drugs, first Part B inclusion)
Why it matters: First IRA negotiated prices effective. Part B physician-administered drugs (oncology, ophthalmology, immunology) now in scope — significantly expands the affected manufacturer set. State PDAB UPLs anchor to these MFPs.
Federal · HHS
Trump reclassifies state-licensed medical marijuana to Schedule III; Kennedy pushes peptide deregulation
Why it matters: Schedule III opens cannabis to mainstream pharmacy distribution and lowers research barriers. Peptide deregulation could fuel a telehealth + compounding boom — manufacturers need state PA + scope-of-practice strategies for both.