Advocacy and Legal Update
2024 – An Eventful Year for 340B and Insurance Reforms
by the Artemis Policy Group
The Hemophilia Alliance advocacy and legal agenda was jam packed in 2024. Legislation focused on reforming the 340B program became active in both the Senate and House and while not passing this year will likely be the starting point in 2025. Private insurance and PBM reform bills moved forward as well as regulations, many of which will benefit HTCs. The article below reflect the highlights of the past year.
340B Reform Bills
Senate Activity – In February, a bipartisan group of Senators, that became known as the “Gang of Six,” released draft legislation focused on reforming the 340B Discount Drug Pricing Program. Describing themselves as “long-time supporters of the 340B program,” Senators John Thune (R – SD), Debbie Stabenow (D-MI), Shelly Moore Capito (R-WV), Tammy Baldwin (D-WI), Jerry Moran (R-KS), and Benjamin Cardin (D-MD) released a draft bill, called the SUSTAIN 340B Act (Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act’’). The bill aimed to address several key areas of policy in the 340B Program, including contract pharmacies, affiliated sites, transparency, and the patient definition.
The Alliance responded to the Senators Request for Information on the draft bill, offering support for some provisions, but voicing concerns regarding others. We applauded the protections the draft bill provides covered entities against discriminatory reimbursement and other practices by payers which limit the benefits of 340B for covered entities and the affirmation of the use of contract pharmacies in the program. However, the current draft bill bases user fees in the 340B Program on the size of the 340B discount off wholesale acquisition costs – this could be very costly for HTCs.
The Artemis team and the Hemophilia Alliance leadership were engaged with the staffers of the six Senators throughout the year and were given the opportunity to comment on revised versions of the bill. We heard from both Democratic and Republican Senators that they wanted to make sure that the legislation would not harm the HTCs and the patient community they serve. As of the writing of this Newsletter, it is unclear if the SUSTAN Act will be introduced in 2024. We definitely think that this is not the end of the SUSTAIN Act as so much work went into formulating the policy reforms it contains. We are monitoring the bill closely and will continue this work into 2025.
House Activity – Action on 340B Reform in the House of Representatives did not occur until May of 2024, when Reps. Bucshon (R-IL), Carter (R-GA), and Harshbarger (R-TN) introduced the 340B ACCESS Act. The House members introduced legislation that was in large part developed by ASAP 340B (the partnership between PhRMA and the National Association of Community Health Centers) and was based on a set of principles that the group released in March 2024. The Hemophilia Alliance was very concerned with these principles when they were released as they would significantly harm HTC participation in the 340B program.
While the bill was based on the ASAP 340B principles, some of the issues that the Hemophilia Alliance identified were addressed, but issues of concern remained. Unfortunately, there are provisions that would harm HTCs, such as a new patient definition and language around subgrantee participation in 340B that don’t recognize the current structures and practice of HTCs, as well as many burdensome transparency requirements. The Hemophilia Alliance sent a letter to the bill’s sponsors outlining our concerns and recommendations for improvements to the bill text. Without further congressional action, the bill will need to be reintroduced in 2025. It is not clear who will take the lead on 340B Reform in the House due to Rep Bucshon’s retirement, so it may take some time for the bill to be reintroduced, but we think it is likely to happen.
Agency and Regulatory Actions on Private Insurance Reform
Positive developments in lawsuits about copay accumulator adjustors – Early in the year two positive developments occurred related to the lawsuit challenging the HHS rule that allows copay accumulator adjustors. First, the judge in the case ruled against the HHS assertion that they would not have to enforce the 2020 Notice of Benefit and Payment Parameters (NBPP) (that only allows copay accumulator adjustors to be imposed when it is a brand name drug with a generic alternative) as they were planning rulemaking on the issue. The judge said no – that the 2020 NBPP policy was in force. The second update is that the federal government withdrew its appeal of the decision. Since then, a few states have decided to implement the 2020 NBPP law and only narrowly allow copay accumulator adjustors.
Progress on Copay Maximizers, too – On April 2nd, the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) released the final NBPP rule for the 2025 plan year. The NBPP set rules and regulations for plans on the federally run Marketplaces and for other private insurance plans subject to the Affordable Care Act’s provisions.
We were very excited that the rule finalizes a policy that would clarify that covered prescription drugs not included in a State’s essential health benefit (EHB) benchmark plan are still considered essential health benefits (EHBs) and therefore, are subject to policies like the annual out-of-pocket max and the ban on annual and lifetime dollar limits. This effectively closes the EHB loophole, disallowing some copay maximizer programs for individual and small group plans!
Alternative Funding Programs (AFPs) – The Hemophilia Alliance took a leadership role in establishing a work group of organizations concerned about the proliferation of alternative funding programs. Through the work group and independently, we met with federal agency officials (including advisors to the President), many Members of Congress and the leadership of the House Education and Workforce Committee on this issue. We also submitted comments on a “Request for Information” from this Committee focused on ERISA plans’ use of deceptive and harmful practices like copay accumulators, copay maximizers and AFPs.
There have been positive steps forward in the fight against these insurance barriers in the past year. The change in the Administration will likely slow down promised regulations, but many of the officials we have been working with at HHS, Dept of Labor, and IRS are career federal employees who will likely remain. Many of these issues were hot topics in the first Trump Administration and we will continue our efforts.
Hemophilia Alliance Hill Day Focused on 340B and Alternative Funding Programs
With the goal of educating Members of Congress on the importance of the 340B Drug Discount Program to Hemophilia Treatment Centers (HTCs) and the bleeding disorders community, 120 advocates headed to Capitol Hill representing various members of the multi-disciplinary HTC team and their patients on April 18, 2024. In addition, attendees educated Congress about our experience with Alternative Funding Programs, being faced by some patients that are insured by large, self-insured employers.
We look forward to Hill Day 2025, which will be Oct 6 – 7, 2025. The Alliance Hill Days have grown in size and benefited greatly with the participation of HTC patients along with their HTC providers. As stated above the reintroduction of 340B Reform bills will likely occur in the second half of the year, making the timing of the Hill Day effective. We encourage all members to attend.
Big picture, we know that the 119th Congress and new Trump Administration taking office in January will consider policies relating to all of the Alliance’s key advocacy areas – protecting access to the 340B Program and ensuring patient access to comprehensive insurance that provides access to the treatments and HTC services that they need. We wish everyone a happy and peaceful holiday season and look forward to Alliance members and partners joining in advocacy in 2025!
Also In This Issue…
Jeff Weighs In
Administration and Operations Update
- 2024 Review – Celebrating Progress and Paving the Future
- 2025 Meetings
Member and Community Relations Update
- MCR’s In the Community
Notes From The Community
- Hemophilia Alliance Foundation Seeking New Board Members
- Unite Walk Wall of Walkers Campaign
- Empowering Change: Raising Awareness for Bleeding Disorders in Women, Girls, and People with the Potential to Menstruate