Vol. 1 · No. 15
Hospitals sue to stop HRSA’s revised 340B rebate pilot
The AHA, the Maine Hospital Association and four safety-net hospitals sued on Oct. 9 to stop HRSA’s revised rebate pilot before its Jan. 1 start. A day earlier, HHS published an economic brief built to defend the CY2027 OPPS payment cut, which CMS has yet to finalize. Both land on the same date.
- Hospitals sued again. The AHA, the Maine Hospital Association and four hospitals asked the federal court in Maine on Oct. 9 to set aside the revised rebate pilot, with a TRO motion.
- HHS laid groundwork for the OPPS rule. An Oct. 8 ASPE brief reports 340B drug payments at non-exempt providers rose from $7.1 billion to $10.7 billion, 2021 to 2023.
- The proposed OPPS cut stays pending: ASP minus 33.4% for 340B drugs, an 8.44% non-drug increase, and a remedy offset rising from 0.5% to 3%.
- Claims-data fights moved to state law. AHA backed Mary Hitchcock Memorial’s injunction bid against Lilly in New Hampshire, and J&J’s contract-pharmacy limit reaches grantees Nov. 3.
- Not a 340B case: PhRMA’s Oct. 7 suit in D.D.C. challenges CMS’s GLOBE Part B pricing model. Our Oct. 8 and Oct. 9 daily briefings mislabeled it as one.
The $244 billion 340B number is a model. Cite it like one.
PhRMA’s new BRG report will show up in 340B fights all fall. Its headline rests on a handful of assumptions the report never stress-tests. Hospitals should answer it with their own data.
In October, Berkeley Research Group published “The Size of the 340B Program.” It estimates that payers and patients spent $244.3 billion in 2025 on drugs bought through 340B, that covered entities and their partners kept a $142.2 billion margin, and that 340B drugs made up 26.5% of net U.S. drug spending. Its last page discloses PhRMA funding.
Before you repeat those figures, or rebut them, know where they come from. BRG starts with HRSA’s $100.0 billion in reported 340B purchases and builds the $244.3 billion through a chain of assumptions about discounts, payer mix and reimbursement. The report publishes point estimates with no sensitivity ranges and too little detail to reproduce each step.
Industry funding does not make the work wrong. Hospital-funded studies deserve the same scrutiny. Some BRG choices push its estimate down. It assumes the prime vendor’s data capture 98% of 340B sales, above the 90% to 95% range MedPAC reported in 2015, and it assumes covered entities earn nothing on cash prescriptions. The right test is whether the method holds up. Three assumptions carry most of the weight, and the report tests none of them.
Start with retail prices. BRG assumes payers reimburse every retail 340B prescription at wholesale acquisition cost, the list price, except Medicaid fee-for-service and cash claims, which it sets at cost. Wholesale acquisition cost is a benchmark. The report cites no claims data showing that plans pay it, and it never shows how the total moves if they pay less.
The retail payer mix comes from one state: Minnesota’s 340B covered entity report from November 2024. BRG uses national CMS data for the non-retail split. It offers no test of whether Minnesota’s mix looks like the rest of the country.
For private non-retail drugs, BRG assumes payers reimburse 3.08 times the 340B price. That figure comes from a 2024 New England Journal of Medicine study by James Robinson, Christopher Whaley and Sanket Dhruva. The study used 2020 and 2021 Blue Cross Blue Shield claims for 404,443 patients on infused drugs. It observed what the plans paid and modeled what hospitals paid manufacturers. Whether it fits all private non-retail 340B spending in 2025 is a separate question the report does not answer.
The report also skips sensitivity analysis. BRG publishes no scenarios and no uncertainty bands. A reader has no way to see how far $244.3 billion shifts under a different retail price, payer mix, private multiple or discount estimate. That is the report’s largest gap.
Two framing errors will travel with the number, though BRG commits neither. The first treats margin as profit. BRG’s $142.2 billion equals modeled reimbursement minus acquisition cost, shared among covered entities, contract pharmacies, technology vendors and consultants. Hospital net income comes only after the costs of running the program. The second treats total spending on 340B drugs as the program’s cost. BRG estimates what payers spent on drugs bought at the 340B price. It does not estimate what they would have spent without 340B. That requires a counterfactual on prices, drug choice, volume and site of care, and BRG does not attempt one.
The report gets several things right. The program is large and growing. BRG cites the Congressional Budget Office’s finding that hospital integration with off-site clinics, Affordable Care Act-era participation growth and contract pharmacy use drove most of that growth. Its call for public data on 340B margins and how covered entities use them is fair. Hospitals that respond to BRG with outrage instead of numbers concede that point by default.
Cite the estimate with its assumptions. If you use $244.3 billion, say in the same sentence that it is a modeled figure that prices most retail claims at list and draws its retail payer mix from one state.
Ask BRG for the sensitivity runs. Request scenarios that change one input at a time, with the evidence for each alternative.
Answer with your own ledger. A covered entity that shows its actual reimbursement by payer, its acquisition cost and where the margin went holds a stronger position than one that disputes a national model in the abstract.
The report documents a big program. It does not settle how big, or what it costs. Policymakers should ask how much the answer changes when the assumptions do.
Douglas McCormack, Founder of Acumen Partners and Chair of MedMatrix Rx, is a health policy attorney, startup CEO, and investor in early-stage health care ventures.
Hospitals sue a second time to stop HRSA’s rebate pilot
What happenedOn Oct. 9, the American Hospital Association, the Maine Hospital Association and four hospitals in Maine, New York, North Dakota and Arkansas sued HHS, HRSA and their leaders in the U.S. District Court for the District of Maine (No. 1:26-cv-00515). With a TRO motion, they ask the court to set aside the pilot and HRSA’s Oct. 1 approvals of 10 manufacturers’ plans under the APA. They argue HRSA understated costs, never quantified benefits, ignored cheaper options and used the wrong legal standard. We found no ruling on the motion as of Oct. 10, 2026.
Why it mattersThe same court enjoined the first pilot on Dec. 29, 2025, and the government agreed to vacatur in February. This complaint leans on HRSA’s own figures: $523.3 million a year in claims-submission cost across 15,249 entities, for 25 eligible drugs HRSA says represent less than 5.5% of 340B sales (91 FR 48883).
- Keep rebate-readiness work on schedule until a court order says otherwise.
- Document projected compliance costs in hours and dollars for the court record.
Jan. 1, 2027 stacks four changes on one date
What happenedFour federal changes now share a Jan. 1, 2027 start. The rebate pilot begins for 21 listed products (18 drugs, counting extended-release versions once) from 10 manufacturers (HRSA). The proposed OPPS rate and 3% remedy offset would apply. CMS’s proposed repository mandate would start. And 15 more Part D drugs move to negotiated Medicare prices (Becker’s).
Why it mattersThe same pharmacy, TPA and revenue-cycle teams absorb all four in one quarter, with cash hits from rebate float, Part B cuts and MFP refunds.
- Build one first-quarter 2027 cash forecast that layers all four changes, with one owner across pharmacy, TPA and finance.
- Confirm TPA and vendor contracts cover rebate submission, MFP reconciliation and repository reporting before year-end.
HHS builds its record for the OPPS 340B payment cut
What happenedOn Oct. 8, HHS’s planning office (ASPE) published “Mission vs. Margin: Misaligned Incentives in the 340B Drug Pricing Program.” It finds inflation-adjusted payments for 340B drugs at non-exempt providers rose from $7.1 billion (2021) to $10.7 billion (2023). Co-author Casey Mulligan, HHS’s chief economist, defended it in STAT the same day. The proposed rule would pay ASP minus 33.4% for 340B-acquired drugs, raise non-drug OPPS payments an estimated 8.44% to keep the change budget neutral, and raise the remedy offset from 0.5% to 3%. As of Oct. 10, 2026, the rule remains a proposal.
Why it mattersCMS built this rate on a 2026 acquisition-cost survey, the step the Supreme Court found missing in AHA v. Becerra (2022). About 29% of 340B hospitals responded with cost data (Covington). CMS estimates the higher offset alone cuts 2027 OPPS payments by $2.3 billion.
- Reprice your separately paid 340B drugs at ASP minus 33.4%, then apply the 8.44% non-drug increase and the 3% offset. Drug-heavy service lines lose. Others gain.
- Check exemptions: children’s hospitals, PPS-exempt cancer hospitals and rural sole community hospitals sit outside the drug cut.
CMS’s repository turns into evidence against HRSA
What happenedCMS opened its Medicare Part D Claims Data 340B Repository for voluntary submissions on Oct. 1 (Becker’s). CMS has proposed, not finalized, mandatory submissions starting Jan. 1, 2027. The Maine complaint now cites the repository. It notes that HRSA rejected a neutral data clearinghouse in one paragraph while CMS opened a similar one on the same day HRSA approved the rebate plans.
Why it mattersOne HHS agency built a clearinghouse while another rejected the idea. That tension feeds the hospitals’ argument that HRSA failed to consider a less burdensome alternative. It also gives covered entities a federal channel for Part D 340B claims data that does not run through each manufacturer.
- Test a voluntary submission with your TPA before any mandate takes effect.
- Point manufacturers that demand Part D claims data to the CMS channel, and record their response.
- Describe the mandate as proposed in board and audit materials until CMS finalizes it.
Claims-data conditions: Lilly in court, J&J’s next date
What happenedOn Oct. 1, the AHA, the New Hampshire Hospital Association and 340B Health filed an amicus brief backing Mary Hitchcock Memorial Hospital’s request for a preliminary injunction against Eli Lilly in the U.S. District Court for the District of New Hampshire (No. 1:26-cv-00616). The hospital sued under New Hampshire’s Consumer Protection Act after Lilly ended its 340B pricing in July over claims data. Separately, Johnson & Johnson’s claims-data condition took effect Sept. 15, with a 45-day submission window for most drugs (Healthcare Dive).
Why it mattersJ&J paired the data rule with a limit of one contract pharmacy within 40 miles of the parent site. That limit applied to hospitals on Sept. 15 and reaches grantees on Nov. 3. Hospitals now test state consumer-protection statutes as the remedy, as Tampa General did against Lilly in Florida (Becker’s).
- Track each manufacturer’s submission clock. J&J says noncompliance puts all of a provider’s J&J 340B pricing at risk of suspension.
- Grantees with J&J contract pharmacy arrangements: designate your single pharmacy before Nov. 3.
- Keep a written record of every manufacturer data demand and your response.
- A ruling on the TRO motion in AHA v. Kennedy, No. 1:26-cv-00515 (D. Me.). We found none as of Oct. 10 (motion).
- The CY2027 OPPS final rule. Comments closed Aug. 31. CMS must finalize before the Jan. 1 start (Federal Register).
- J&J’s Nov. 3 date for grantees. The one-contract-pharmacy limit extends from hospitals to grantees (Healthcare Dive).
- PhRMA’s GLOBE suit in D.D.C. The Oct. 7 suit targets the GLOBE model, finalized Sept. 30 and starting Jan. 1, 2027. It is a Part B pricing fight, not a 340B case (Skadden).
- BRG / PHRMAThe Size of the 340B ProgramOct. 2026
- NEJMRobinson et al., Hospital Prices for Physician-Administered DrugsJan. 2024
- D. MAINEAHA v. Kennedy, No. 1:26-cv-00515, complaintOct. 9
- HHS ASPEMission vs. Margin: Misaligned Incentives in the 340B Drug Pricing ProgramOct. 8
- STATHow CMS plans to fix a major flaw in 340B (Mulligan)Oct. 8
- FEDERAL REGISTERCY2027 OPPS proposed rule, 91 FR 41734July 7
- FEDERAL REGISTER340B Rebate Model Pilot notice, 91 FR 48883Aug. 3
- HRSA340B Rebate Model Pilot Program: approved plansOct. 2026
- COVINGTONCMS proposes CY2027 Medicare payment changesJuly 2026
- AHAAmicus brief backs hospital challenge to Lilly policyOct. 2
- HEALTHCARE DIVEJ&J adds 340B claims-data requirementSept. 14
- BECKER’SCMS opens 340B data repositoryOct. 2