Advocacy and Legal Update
340B Reform Efforts Pick Up Steam
by Artemis Policy Group
This summer has seen a sharp uptick in Congressional attention to 340B policy. Senator Cassidy, outgoing Chairman of the Senate Committee on Health, Education, Labor and Pensions, released draft 340B legislation for public comment. A reconstituted Senate “gang of 6” introduced an updated version of the “SUSTAIN 340B Act” (S. 5244). Meanwhile, on the House side, four lawmakers have introduced their own bill: H.R. 9599, the “SECURE 340B Act.”
Briefly, the various bills:
- Give manufacturers the choice of requiring rebates or discounts, unless covered entities meet certain conditions (Chairman Cassidy discussion draft).
- Prohibit rebates for four years and prohibit limits on covered entity use of contract pharmacies – but require covered entities to submit data to a new data clearinghouse (SECURE Act, H.R. 9599).
- Reaffirm the original intent of the 340B program (clarifying that the program requires manufacturers to provide point-of-purchase discounts, rather than rebates), and codify covered entities’ authority to use contract pharmacies, while also providing for audits and reporting, and establishing a 340B data clearinghouse (SUSTAIN 340B Act, S. 5244).
A more detailed summary of the three bills – and Administration 340B activities – can be found at this LINK.
While none of the 340B reform bills are moving fast toward passage, the Hemophilia Alliance is of course keeping close watch on all these developments. At a very high level, we can report that each bill has some good policies and some minor to major areas of concern for HTCs. In June and July, Alliance staff met with some of the Congressional offices that are driving reform efforts. We provided information about how HTCs use 340B, the unique characteristics of HTCs, HTC reporting requirements, how HTCs can utilize 340B program income, and the importance of maintaining HTC ability to participate in the program. The Hemophilia Alliance will continue to engage with the respective bill sponsors to explain our concerns and recommend changes to improve the problematic sections of the bills. The Alliance’s 2026 Hill Day this September will be an ideal time to reinforce these messages with lawmakers.
Funding for Fiscal Year 2027
Senate and House Pass Competing Short-term Funding Bills
Trying to prevent a fight over federal spending and potential partial government shutdown before the mid-term election, the Senate passed a continuing resolution (CR) in early August to fund the government at current levels from the October 1, 2026, start of fiscal year 2027 through December 11th. The Senate bill would also prevent a controversial new rule about government grants from taking effect before December. Because the Senate bill differs from the House-passed CR, the two chambers will have to work out their differences when they return from recess in September in order to enact a spending measure.
House Passes Budget Resolution
On July 22, 2026, the House of Representatives passed a Fiscal Year (FY) 2027 budget resolution for a third reconciliation package. The resolution provides budget instructions for House committees overseeing many government programs (e.g., defense, intelligence, and agriculture) – but it provides no instructions to the committees with jurisdiction over health insurance, Medicaid, or Medicare (Energy and Commerce Committee and Ways and Means). As a result, the budget resolution does not directly affect federal health policy. The bill now goes to the Senate, where its passage is unclear. If it passes, then Congress needs to separately write and pass the bill, so there are steps still to go! Some in Congress are pushing for a 4th reconciliation package this Congress to tackle issues related to fraud, waste, and abuse in health care programs but there likely won’t be sufficient time to pursue another bill.
More on Medicaid Work Requirements
We have previously reported on guidance released by the U.S. Centers for Medicare and Medicaid Services (CMS) regarding State implementation of the work reporting requirements contained in last year’s One Big Beautiful Bill Act. In late July, the Hemophilia Alliance together with NBDF and other bleeding disorders partners filed comments responding to the guidance, urging CMS to broaden its unduly narrow exemptions for people with “serious or complex medical conditions.” Bleeding disorders are undeniably “serious or complex” and the loss of coverage for people living with these conditions would have devastating consequences for their health. The Hemophilia Alliance is working to develop toolkits and other resources for HTCs to use as the Medicaid work reporting requirements come online.
Policy Changes to HHS Salary Rate Limits
Hemophilia Treatment Centers should remain cognizant of restrictions related to payment of employees under their grant. Every year, Congress sets a limit on how much salary a person can be paid with HHS grant or cooperative agreement funds. This salary limit applies to sub-awards and subcontracts. It also applies to all individuals working on the award, including staff, contractors, or consultants.
Under the rules, recipients cannot use award funds to pay anyone more than the Executive Level II rate which is set at $228,000 for 2026. Importantly, in recent years, HHS updated the HHS Grants Policy Statement so that the salary limit applies to both direct and indirect costs for HHS awards. For staff whose salary rates exceed Executive Level II amount, recipients may pay the excess from non-federal funds. Please reach out to the Hemophilia Alliance and to your Regional leadership if you have questions regarding this policy.
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Also In This Issue…
Jeff Weighs In
Member and Community Relations Update
- Understanding the Differences between HANS Agreements and Single Case Agreements
Administration and Operations Update
- New This Fall: Event Resources in One Convenient Hub!
- MPBA 2027 Registration Now Open!
- Annual Member Dues – Past Due!
- 2027 Alliance Meeting Calendar – Save the Dates!
Notes From The Community
- VWD Connect Foundation Workshop – October 9-11, 2026