Advocacy Update
340B Reform Legislation – Current Status and Predictions
by Artemis Policy Group
2024 has been an active year for 340B Reform legislative proposals. As of now, there are two comprehensive 340B reform proposals and several other smaller 340B transparency/reform bills. See the table below for brief summarizes the four bills that merit the most attention.
Artemis continues to be skeptical about the probability of comprehensive 340B reform occurring this year. Of the two comprehensive proposals –340B Access Act (the House bill) and the SUSTAIN 340B Act (the Senate bill) – one has few co-sponsors who are all of one party and the other is yet to be introduced, and neither are bicameral. These characteristics create significant barriers to passage of either proposal this year. It is most likely that these bills will not move forward this year but will be reintroduced in the new Congress next year.
118th Congress Bill Details | What Does Bill Do? | Impact on HTCs |
---|---|---|
IHR 4758: Accelerating Kids’ Access to Care Act; introduced 7/19/23 by Rep. Lori Trahan (D-MA); Passed the House and referred to the Senate on 9/17. | Primarily a bill to expand access to care across state lines for kids in Medicaid and CHIP, but the House version was amended in July 2024 to include a provision on spread pricing in Medicaid. Covered entities can be paid more than actual acquisition cost (AAC), but they can’t be paid more than what other providers are being paid, and they must report their margins for Medicaid to HHS, which will make data public. | Would apply to HTCs – transparency would be required and made public. |
HR 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; introduced 5/15/23 by Rep. Bucshon (R-IN); passed House Energy and Commerce Committee on 5/24/23 | Requires hospitals to report lots of 340B data to HHS (patients served, insurance status, costs incurred at the sites, reimbursement) that would be made public. HHS would have authority to extend to grantees. | Could apply to HTCs, but it would require HHS to proactively decide to include us when implementing the law. |
HR 8574: the 340B ACCESS Act; introduced 5/28/24 by Reps. Bucshon (R-IN), Carter (R-GA), and Harshbarger (R-TN). | This bill stems from ASAP 340B (which is the NACHC/PhRMA nonprofit pushing for reforms) and is one of the two comprehensive 340B reform proposals. | There are some good provisions for HTCs and a number of harmful ones. |
Not yet introduced: SUSTAIN 340B Act. | This is the bipartisan comprehensive reform bill that may be introduced by the Gang of 6 Senators in September. | There are some good provisions for HTCs and we have been actively meeting with the staff to try to mitigate potential harmful provisions. |
If any 340B reform proposals become law this year, it would most likely be as part of a larger package and resemble one of the transparency provisions in HR 3290, which was passed by the Energy and Commerce Committee or HR 4758, which passed the House. The transparency/data reporting provisions could have traction both because they could be seen as middle-ground proposals that respond to some of the biggest concerns (lack of transparency generally and oversight over hospitals in particular), but also because the spread pricing provision of HR 4758 is included as a pay-for for the other provisions of the bill. This makes HR 4758 a greater chance of moving forward.
Proposed Strategy for Remainder of 2024
Our main goals are to protect HTCs from harmful legislation this year as well as in 2025 when some of these bills will likely be introduced. To accomplish this, we plan to meet with the relatively small group of staff/Members who will be deciding what is included in an end-of-year package to share our concerns. We will alert HTCs if any grassroots contacts (emails and calls) are needed and if so, provide updated materials – fact sheets and talking points. We will also continue to collaborate with our grantee colleagues and have already begun outreach to the drug manufacturers in the bleeding disorder space, to ensure their continued support for HTCs in the 340B program.
Also In This Issue…
Jeff Weighs In
Administration and Operations Update
- Fall Member Meeting Review
- Upcoming Meetings
Legal Update
- 340B Update – Contract Pharmacy Litigation and State Laws to Related Pharmacies and PBMs
- HHS Adopts Changes to the Uniform Grants Guidance
MCR Update
- Reception for National Youth Leadership Institute (NYLI) at BDC 2024
Notes From The Community
- YETI Reunion at the Bleeding Disorder Conference