Key Takeaways from the 2025 340B Summer Conference

July 31, 2025 Sponsored Content Views

Important Areas To Focus on Now
and in the Coming Months

New Provider Reporting Requirements

Although these protections have been welcomed, there is a growing number of states adding provider reporting requirements. These requirements range from reasonable to burdensome, requiring more time and resources from covered entities (CEs) – many of whom are already stretched thin.

There has been a growing call for transparency for 340B CEs by both state and federal lawmakers. Some of the concerns CEs have regarding these requirements include the additional time and resources necessary to pull together data and reports, the way the data will be reported on by government authorities and lawmakers, the liability of sharing information that could be deemed confidential, as well as the actual timing of the required reports.

Federal Level Updates

The ‘Big Beautiful Bill’ has passed and includes expansion of tax cuts and increased spending towards immigration enforcement and defense. Health care providers and patients will experience significant reimbursement cuts, loss of insurance and subsidies. The new law includes over $1 trillion in Medicaid cuts with over 10 million Americans expected to lose insurance coverage by 2034. These cuts will kick-in after the midterm elections in November 2026.

Possible Proposed Legislation

There are three key bills that 340B stakeholders should keep an eye on:

The ‘340B Patients Act’ would fully restore access to 340B discounts in the contract pharmacy setting. The bicameral bill, which was introduced during the week of the conference, is sponsored by Rep. Doris Matsui (D-Calif.) and Sen. Peter Welch (D-Vt.) in their respective chambers.
The pharmaceutical industry endorsed ‘340B Access Act’ ,which would make dramatic changes to the 340B program, including imposing significant restrictions such as preventing most hospitals from using 340B discounts for insured patients. The bill, which was introduced last year by a number of influential House Republicans including Reps. Buddy Carter (R-Ga) and Diana Harshbarger (R-TN) has not been reintroduced this year but some form of the bill is likely to be introduced at some point soon. It is unclear whether the National Association of Community Health Centers (NACHC) will endorse the bill like it did in the last session of Congress but NACHC’s presence at the 340B Coalition Conference, after a few years absent, could indicate that the group is no longer working closely with the trade group PhRMA or has reservations about partnering with the drug industry again, some participants speculated.
The ‘Sustain 340B Act’ will likely get the most attention. The bill, which was only introduced in draft form during the last session of Congress and has not yet been introduced this year, is being led by three Republican and three Democratic Senators called the “Gang of Six”. This legislation would restore access to 340B pricing in the contract pharmacy setting, provide more clarity on which patients and child sites would be eligible for 340B discounts. It would also require CEs to submit reports on how 340B savings are used and introduces a small user fee intended to fund oversight of the program. It also touches on number of other areas including duplicate discount prevention, and protections from what CEs describe as PBM discriminatory practices. Although the Sustain 340B Act has the most potential due to its bipartisan nature, progress at the state level could make it harder to get something done at the federal level.

Executive Branch

Although previously attempted and overturned by the Supreme Court during the last Trump presidency, the administration is again expected to attempt to make significant Medicare Part B cuts to 340B hospitals. The Trump administration has recently announced that it plans to conduct a survey of Medicare acquisition costs which 340B provider advocates worry will be used as a pretext to cut reimbursement. This could result in disproportionate share hospitals losing the benefit of 340B pricing for Part B drugs, which are administered by physicians and are some of the most expensive drug products in the market.

Inflation Reduction Act (IRA)

The IRA gives CMS the ability to negotiate directly with manufacturers. This requires manufacturers to provide the Maximum Fair Price (MFP) directly to a pharmacy either prospectively or retrospectively. Collecting the data to determine reimbursement could cause delays in reimbursements as it may take upwards of 40 to 45 days for the pharmacy to receive a refund payment, putting the burden of funding the program on the pharmacies.

The IRA is set to go live in January 2026 and initially includes ten (10) Part D drugs: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and Fiasp/Novolog. In 2027, fifteen (15) more Part D only drugs will be added to the program and in 2028, another fifteen (15) including both Part B and D drug products will be added. The drug industry cites the overlap of the IRA with 340B as one of the primary reasons why they would like to implement a 340B Rebate Model instead of a traditional upfront discount.

Shifting 340B Oversight to CMS

The Trump administration is looking to shift oversight of the 340B program away from HRSA to CMS. It is unclear whether this move will become reality. However, the recent Supreme Court decision to allow the HHS reorganization to proceed for now, may add momentum. Since CMS already oversees the Medicare and Medicaid drug programs, there is some logic for the transition. However, as Ted Slafsky of 340B Report mentioned during his talk at an event hosted by Verity Solutions, many 340B advocates are concerned that CMS has a long tradition of implementing policies that they believe have undermined the 340B program including significant Medicare and Medicaid cuts.

Pharma’s Proposed Rebate Model

Rebate Model

The proposed rebate model would require CEs to purchase 340B eligible drugs at full price, wholesale acquisition cost (WAC), and later submit claims to receive rebates equivalent to the 340B discount. In the manufacturers proposed model, any IRA rebates already given to the government would be taken out of reimbursements on the 340B side.

Rebate Model Concerns

340B providers have a range of concerns with converting the 340B program from an upfront discount to back-end rebate. They are opposing these efforts in court and raising their concerns with the administration and Congress. Among their worries: CEs don’t want to be responsible for floating money to Pharma and waiting on a refund that may or may not come. Another issue with the model is that 340B is reimbursed at a package level while other reimbursements (i.e. IRA) come at a pill level. If a rebate model comes into play, not every manufacturer will participate, meaning that TPA’s and CEs will need to account for both the current upfront discount model and the rebate model simultaneously. This will add an additional layer of complexity.

Rebate Legal Battle

Five manufacturers have attempted to implement a rebate model and have been met with strong opposition by HRSA. HRSA not only sent letters telling the companies they could not implement the model with approval from the government but the agency threatened their removal from the Medicaid and Medicare programs. The manufacturers responded by suing HHS in two separate lawsuits.

Both cases have ended up in federal court in Washington, D.C. In both cases, the respective judges have sided with HRSA’s argument that rebates cannot be implemented unilaterally. However, under pressure from a judge overseeing one of the cases, HHS agreed to provide guidance on how to alleviate manufacturer concerns about ensuring that there is a process in place to prevent duplicate discounts.

Conclusion

It was clear from the conference that the 340B program stands at a critical juncture. With a new administration that is skeptical of the 340B program and a potentially less sympathetic Congress, the path ahead will require vigilance, collaboration, and adaptability from all 340B stakeholders. 340B providers will need to be more active than ever at both the state and federal level.