Advocacy Update
The 2024 Election & Potential Impacts on HTCs
by the Artemis Policy Group
With the exception of a handful of House races, the results of the 2024 election are known. Beginning in 2025 with the 119th Congress and the January 20th Presidential Inauguration, Republicans will take control of the White House and the two chambers of Congress, the Senate flipping from Democratic control and the House maintaining its Republican leadership.
President-elect Trump has already begun shaping his second administration – an effort far more organized than after his first win. With a Republican trifecta – control of the White House, House, and Senate – the President’s agenda will have a green light in moving forward. This will include approving appointments, setting legislative priorities, and minimal Congressional oversight of the Executive Branch. Given the incredibly tight margins in both the House and the Senate, however, most legislation will need bipartisan support.
What to expect in the lame duck?
The 118th Congress still has until the end of 2024 to finish out their legislative work. This may include passing a fiscal year 2025 funding bill running through September 30, 2025, the end of the fiscal year and a debt ceiling extension. Congress is also looking at non-controversial, bipartisan health bills, such as preventing the Medicare physician fee cut and extending the telehealth flexibilities under Medicare and Medicaid, which are set to expire at the end of 2024. PBM Reform may also be included in an end of year package.
What to expect in 2025?
The start of the 119th Congress in January 2025 brings less certainty. Republicans in Congress are planning to use the reconciliation process early in the year to pass President-elect Trump’s promised tax cuts and potentially other policies that would increase federal spending. Reconciliation bills require only a simple majority of votes in both the House and the Senate, but all provisions must affect federal spending and income. Typically, 60 votes are needed to pass legislation in the Senate. The top priority for a reconciliation bill is extending or making permanent the 2017 tax cuts which are set to expire at the end of 2025. To offset the cost of that provision, we may see policies that significantly impact the Medicaid program, such as capping federal spending on Medicaid and limiting Medicaid coverage and/or payments. This is of particular concern to the Bleeding Disorders community as it is estimated that 30% – 40% of patients in the in the US are insured under Medicaid.
With the extensive head start made by Congress to legislate 340B reforms in 2024, the potential for Congress to proceed with 340B Reform Bills in 2025 is more likely. Action on these bills would follow the reconciliation bill process described above. The major 340B reform bill in the House, HR 8574 – the 340B Access Act will need to be reintroduced next year with or without additional changes. The Senate 340B draft bill, known as the SUSTAIN 340B Act, is yet to be introduced and it is unclear if it will remain a bi-partisan initiative. Of the six Senators engaged in the SUSTAIN Act, two have retired and Senator Thune will become the Senate Republican Leader and may choose to no longer participate in this effort.
The Trump Administration and the Republican led Congress may also move proposals to weaken the Affordable Care Act as well as policies that restructure federal health agencies, such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
Active Advocacy is Needed
The Hemophilia Alliance will continue to track policies at the federal level that may impact HTCs and the patients they serve. We will coordinate our efforts with the national bleeding disorders patient organizations. We will want to engage all HTCs in early 2025 as many of you will be represented by a new Senator and/or Representative. Regardless of the election results the Hemophilia Alliance will continue to advocate for its priorities – assuring HTC participation in the 340B program and improving patient access to specialized care and treatments.
For questions, contact the Artemis Policy Group Team – jgray@artemispolicygroup.com or eriker@artemispolicygroup.com
Hemophilia Alliance and National Bleeding Disorders Organizations Advocate for Improved Categorization of Bleeding Disorders Treatments under US Pharmacopeia
by the Artemis Policy Group
The Hemophilia Alliance joined with NBDF, HFA and the Coalition for Hemophilia B to comment on the Draft of the United States Pharmacopeia Drug Classification (USP DC) 2025. The letter sent on October 31, 2024 can be found here.
Background
The USP organizes drugs into categories and classes and is more focused on Medicare Part D drugs than infusions covered under Medicare Part B. Recently, they have begun a broader categorization, called USP DC, which includes Part B drugs. As of now, all bleeding disorders treatments (for Hem A, Hem B, VWD and rare bleeding disorders) are in a single category (Blood Products and Modifiers) and a single class (Blood Component Deficiency/Replacement).
Since all bleeding disorders treatments are combined in a single category and class, health plans only need to cover one Hem A treatment to satisfy the ACA requirement that health plans cover at least 1 -2 drugs per category and class. This would allow plans to not cover treatments for Hem B, VWD, or any of the rare bleeding disorders.
Bleeding Disorder Community Advocacy
Last year, we met with and sent a letter to USP asking them to separate products for blood disorders into separate classes for Hem A, Hem B, Thrombosis, Rare Blood Disorders, and VWD. USP considered this, but did not implement this change. We were told by USP that it was too big of a change to make quickly and wanted more time to consider it.
The October letter reiterates our community’s request that USP disaggregate the treatments for bleeding disorders into separate categories and classes of the USP DC by disorder. It makes the following case:
The products grouped together in the single category and class have very different mechanisms of action and routes of administration. For example for Factor VIII treatments, the single category and class includes intravenously infused clotting factors (including plasma-derived, porcine, recombinant/standard half-life, recombinant/extended half-life) and subcutaneously administered bispecific monoclonal antibody (non-factor, long half-life). Combining these many products – with widely varying indications, mechanisms of action, and routes of administration – into a single category and class contradicts USP’s stated goal of “creating a comprehensive classification system for use in drug formulary development . . . [and providing] guidance towards the design and comparison of balanced formularies.”
The letter asks that USP disaggregate the different products into classes based on primary indication. Notably, even in the more granular categorization/classification that is proposed, no category and no class should contain fewer than three drug examples – consistent with USP DC principles.
Contact Johanna Gray with any questions at jgray@artemispolicygroup.com.
Also In This Issue…
Jeff Weighs In
Member and Community Relations Update
- Advocacy in Your State – Don’t Miss Out On Providing An HTC Voice!
- Member and Community Relations National Patient Organization Partnership Update
Administration and Operations Update
- Website Access, Member Event Registration and the Data Portal
- Upcoming Meetings
Notes From The Community
- The Alliance Pharmacy Pledges Support for HFA’s Helping Hands Program
- BD SUMHAC Accepting Applications for the 2025 State Advocacy Program!