Reps. Doris Matsui, D-Calif., and Tracey Mann, R-Kan., introduced the bipartisan PROTECT 340B Act on Oct. 29. Here are eight things to know:
- The Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act would protect 340B covered entities from discriminatory practices by pharmacy benefit managers and insurers. The Association of American Medical Colleges and other major hospital groups have endorsed the bill.
- The bill would prevent PBMs and insurers from offering lower reimbursement rates for 340B drugs, imposing additional fees on covered entities and their contract pharmacies, excluding 340B contract pharmacies from their networks or otherwise imposing discriminatory conditions based on participation in the program. It would also create a third-party clearinghouse to identify and resolve duplicate discounts.
- This version differs from earlier ones in that it would require HHS to terminate the 340B Rebate Model Pilot Program, which is set to take effect Jan. 1, 2027. The AAMC opposes the use of rebates in the 340B program and has also endorsed legislation that would delay the pilot.
- The AAMC has backed earlier versions of the bill. The PROTECT 340B Act was first introduced in 2021 by then-Rep. David McKinley, R-W.Va., with then-Rep. Abigail Spanberger, D-Va., as a cosponsor. The bill would have prohibited commercial insurers and PBMs from targeting 340B entities with discriminatory reimbursement terms.
- The rebate pilot faces opposition on several fronts. HRSA has approved 10 drugmakers to participate, the American Hospital Association and others have sued to block it and a separate bipartisan House bill would delay it for two years.
- The bill joins several other 340B proposals in Congress. Six senators introduced the SUSTAIN 340B Act on Aug. 5, which would sunset the rebate pilot one year after enactment and replace it with a third-party data clearinghouse and would bar group health plans, insurers and PBMs from reimbursing 340B entities differently from other providers. The AHA backed the Senate bill in an Oct. 27 letter but asked for changes to provisions on manufacturer audits of contract pharmacies, the patient definition and child sites.
- In the House, the bipartisan SECURE 340B Act (H.R. 9599), introduced July 6 by Reps. Scott Peters, D-Calif., and John Joyce, R-Pa., would pause manufacturer rebates for several years, establish a new patient definition and create contract pharmacy standards. The 340B ACCESS Act, introduced by Reps. Buddy Carter, R-Ga., and Diana Harshbarger, R-Tenn., in September 2025, would add patient affordability requirements and restrict PBMs and other third-party administrators from profiting off the program. Sen. Bill Cassidy, R-La., also released a discussion draft in June that would let manufacturers choose among discounts, rebates or a claims-repository model.
- The anti-discrimination provisions address practices at the center of recent litigation. New York City-based Mount Sinai Health System, Ann Arbor, Mich.-based Michigan Medicine and Kansas City, Kan.-based University of Kansas Health System sued CVS Health in May, alleging a scheme to divert about $250 million in 340B savings through deflated reimbursement rates, and Lexington, Ky.-based University of Kentucky filed a similar suit Oct. 27.
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