Visante’s attendance at the 2025 340B Winter Coalition Conference proved both insightful and impactful. Discussions, policy updates and industry trends provided valuable insights into the future of the 340B program. While there was much to unpack, here are three key takeaways that our team found most critical.
Leadership Changes at the Federal Level
Six months into the new administration has brought many changes to Washington, D.C. Key roles relevant to 340B include a new Health and Human Services secretary—Robert F. Kennedy Jr.—and significant changes in Congress. Sen. John Thune (R-S.D.), now the new Senate Majority Leader, was one of the original group of six senators sponsoring the bipartisan 340B SUSTAIN Act. He has been replaced by Sen. Markwayne Mullin (R-Okla.) as a co-sponsor. The first discussion draft of this act, issued in February 2024 along with a Request for Information to stakeholders, addressed multiple areas of the 340B Drug Discount Program, including, but not limited to, the patient definition, government oversight, transparency and contract pharmacy restrictions. The following represent some of the first draft’s many provisions:
- removal of manufacturer restrictions on 340B pricing for contract pharmacies;
- annual reporting—included as an addendum to the Medicare Cost Report—of specific data points relative to 340B program savings, including a description of the covered entity’s (CE’s) use of the savings;
- establishment of a “340B Drug Discount Program Data Clearinghouse” through an independent entity— without conflict of interest—to help ensure program integrity;
- prohibition of pharmacy benefit manager (PBM) discrimination against 340B CEs and contract pharmacies dispensing 340B drugs and establishment of civil monetary penalties for PBMs that engage in discriminatory practices; and
- establishment of a “User Fee Program” charged to participating CEs, the revenues of which would be put toward enhanced program oversight and operations, including the data clearinghouse, the Office of Pharmacy Affairs Information System, and Health Resources and Services Administration (HRSA) audits.
Two additional co-sponsors of the act, Sen. Ben Cardin (D-Md.) and Sen. Debbie Stabenow (D-Mich.), have retired and were replaced by Sen. John Hickenlooper (D-Colo.) and Sen. Tim Kaine (D-Va.). An updated draft of the act could potentially be released in 2025.
As Republicans have the majority in the House and Senate, chairs of the committees in both chambers have also transitioned. Sen. Bill Cassidy (R-La.) now chairs the Senate Committee on Health, Education, Labor and Pensions. In contrast, Rep. Brett Guthrie (R-Ky.) chairs the House Committee on Energy and Commerce, and Rep. Buddy Carter (R-Ga.) leads its Health Subcommittee. Mr. Cassidy has a track record of opposition to the 340B program, as does Mr. Carter, who co-sponsored the 340B ACCESS Act. The act, which largely imposes new 340B program restrictions on hospitals and could have implications for grantees, may be reintroduced this year. Mr. Guthrie has previously voted in favor of bills supporting imposed reporting requirements for 340B hospitals, as well as pricing transparency relative to Medicaid Managed Care Organization plans.
Continued Manufacturer Actions And Negative Advertising Campaigns
Five manufacturers and one vendor are now suing HRSA over the recently proposed rebate process, which will likely have significant financial implications for 340B CEs if implemented. The rebate model forces CEs subject to the group purchasing organization prohibition to purchase 340B drugs at the higher wholesale acquisition cost price initially and submit claims data, both for contract/entity-owned pharmacies and physician-administered drugs, which the manufacturer will then review and determine whether to issue a rebate on that drug to the CE. Numerous concerns exist about this proposed model and its impact on 340B CEs.
Litigation continues between manufacturers and states, with laws addressing contract pharmacy restrictions in the 340B program. The courts mainly favor the states, but many cases have been appealed. Several more states have introduced bills this year in opposition to the current contract pharmacy 340B purchasing restrictions imposed by manufacturers.
In response to these laws, negative advertising campaigns tied to dark money have additionally begun airing on television and appearing on mobile billboards parked outside of state congressional buildings where bills protecting CEs from contract pharmacy restrictions are being voted upon. These ads primarily have been targeting largely conservative states to sway lawmakers and serve as a call to action for the population to contact their congressmen to “Stop 340B.” At least one ad claims that 340B opposes President Trump’s agenda. In contrast, others claim that the 340B program subsidizes traditionally hot-button issues for conservatives, including illegal immigration and gender-affirming care.
As the 340B program includes only nonprofit entities that serve large proportions of the indigent, uninsured population, the original intent was to allow CEs to use the funds from the 340B program to put back into services and programs to benefit the underserved communities of those entities—even if to keep the doors open simply.
The Inflation Reduction Act
The Inflation Reduction Act (IRA), enacted in 2022, includes a provision for the government to negotiate price caps on the most expensive drugs covered by Medicare for Part D and B plans. These price caps are called the Maximum Fair Price (MFP). The CEs will be required to purchase these drugs for Medicare Part D patients at the lower of either the MFP or the 340B price. The MFP for 10 already-identified drugs will go into effect in 2026. Fifteen additional Part D drugs recently were determined to be included in this list beginning in 2027. Fifteen more drugs will again be selected for 2028, but this list will also include Medicare Part B drugs. Manufacturers are not required to offer a 340B discount on a claim’s National Drug Code (NDC) while paying an MFP rebate on the same claim. There is no identified method by which manufacturers can determine whether a drug used pursuant to a claim was purchased at the 340B price or the MFP. Manufacturers cannot require modifiers to make this determination but must submit plans to the Centers for Medicare & Medicaid Services to identify drugs purchased at 340B versus the MFP by Sept. 1, 2025.
Multiple concerns for CEs have arisen in response to the IRA, including whether MFP refund denials could occur on a claim if a manufacturer determines a 340B-purchased drug may have been used and whether manufacturers will deny CEs the 340B price on a drug absent wholesaler invoices and 340B claims data. CMS has indicated it will not intervene in pricing disputes between manufacturers and CEs. The CEs are encouraged by NDC to calculate the impact of the IRA on their respective programs to estimate savings losses reasonably before implementation. Spreadsheets to assist with these calculations can be found at bit.ly/4jK7tip.
Dr. Rainey is the 340B program director at Visante.
This article is from the August 2025 print issue.