In This Issue...
Jeff Weighs In
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.
Member and Community Relations Update
Advocacy in Your State – Don’t Miss Out On Providing An HTC Voice!
by Angie Blue, Director of Member and Community Relations
Did you know that many local Bleeding Disorders Chapters and Foundations are active in state advocacy? Many states have Bleeding Disorders Advocacy Committees led by local NBDF/HFA Chapters that welcome involvement and input from the local HTC staff.
Chapters typically convene their committees and all interested community members at the end of the year to discuss priorities for the coming year. If you are not aware of state advocacy efforts in your state, we encourage you to reach out to your local community organizations to see if an Advocacy Committee exists, and if not, we encourage you to team up with your local chapter to work on state level issues together. As a reminder, HTC staff are allowed to educate on advocacy issues and can provide valuable real-world examples of issues.
The Alliance is also rolling out an initiative to better understand and inform our member HTCs of state level legislation and regulations that may affect HTCs and their patients. Look for more on this in 2025. If you have any questions about state advocacy initiatives and how you can get involved, please connect with your local chapter and/or contact your Hemophilia Alliance Member and Community Relations Director.
Member and Community Relations National Patient Organization Partnership Update
by Karen Bowe-Hause, Director of Member and Community Relations
As part of our sponsorship with National Bleeding Disorders Foundation (NBDF) Partners in Progress campaign, the Hemophilia Alliance was once again invited to join the Chapter Leadership Seminar (CLS) in San Antonio, TX on November 18th – 21st. CLS brings Chapter Executive Directors and Board Members, Industry Partners, and NBDF Staff and Board of Directors from across the country together to participate in a series of training activities. Several goals of this annual program include improving a Chapter’s capacity to fundraise, providing innovative programs and services, growing advocacy impact, and sharing non-profit best practices. As a presenting sponsor to CLS, the Alliance was invited to give a 5-minute welcome speech during the opening reception.
Prior to the meeting, the Alliance met with NBDFs leadership team to discuss continued collaboration in 2025 on a variety of programs including:
- The projected launch of an HTC/Chapter ‘Think Tank’ initiative
- Hemophilia Alliance/HTC involvement in NBDFs Capacity Building initiative
- Collaboration to increase focus on addressing the hematologist shortage in HTCs
- Increased emphasis on HTCs as a vital resource for patient care and sustainability of HTCs and protection of 340B pharmacy programs
The Alliance also continues collaboration efforts with Hemophilia Federation of America’s (HFA) leadership team in anticipation of the 2025 2nd Annual Mild Matters Physician Forum. The goal of this provider forum is to assist in bridging the gap between patient advocacy and HTC providers to engage in critical diagnostic and treatment conversations for people with mild bleeding disorders.
Administration and Operations Update
Website Access, Member Event Registration and the Data Portal
by Administration & Operations Team
As a reminder, to access our member restricted contents or to register for our meetings and webinars, a website login is required. To request approval to log in, simply click on the “Join Now” from the main homepage. Once we verify that you are at a member HTC your signup request will be approved, and you will receive an email confirmation. Please don’t forget to add the domain name @hemoalliance.org to your email whitelist (a.k.a. “safe senders list”) to ensure you receive all communications from us.
In addition to your login for website access, the Alliance has a data portal for member HTCs to enter their factor purchase data. Accessing the data portal requires a separate login username and password from the member website login. While HTCs can have more than one user registered in the data portal, we ask that those entering monthly purchase data do this as one of their key responsibilities.
Please reach out to Jennifer Anders (jennifer@hemoalliance.org) to request access to the data portal. To access the data portal from the website, select the “Menu” button in the top right of the website and then select “Data Portal Login” from the Member Area.
UPCOMING MEETINGS | DATE |
|---|---|
Pharmacists CE Conference [REGISTRATION NOW CLOSED] | January 22 – 24, 2025 (San Diego, CA) |
Linda Gammage Social Workers CE Conference [REGISTRATION NOW CLOSED] | February 26 – 28, 2025 (Austin, TX) |
Spring Members Meeting [SAVE THE DATE] | March 9 – 11, 2025 (Location: TBD) |
Nurses CE Conference [SAVE THE DATE] | April 27 – 29, 2025 (Orlando, FL) |
New HTC Staff Orientation [SAVE THE DATE] | April 29 – May 1, 2025 (Orlando, FL) |
Physical Therapists CE Conference [SAVE THE DATE] | May 14 – 16, 2025 (Phoenix, AZ) |
Fall Members Meeting & Hill Day [SAVE THE DATE] | October 5 – 7, 2025 (Washington, DC) |
Notes From The Community
The Alliance Pharmacy Pledges Support for HFA’s Helping Hands Program
In October, The Alliance Pharmacy (TAP) announced a matching donation challenge, encouraging HTCs, specialty pharmacies, and individuals to donate to the Hemophilia Federation of America’s Helping Hands Program. TAP has pledged a $100,000 donation and encourages others to participate. HFA’s Helping Hands Program, which assisted many community members and families, was discontinued in 2024. TAP hopes its effort will bring back this important resource to the community. For more information, see the TAP press release and video – TAP Donation Challenge.
BD SUMHAC Accepting Applications for the 2025 State Advocacy Program!
by Karen Bowe-Hause, Director of Member and Community Relations
We are thrilled to announce the 2025 State Advocacy Program and the opportunity to invite you to join us in this critical work! The Bleeding Disorders Substance Use and Mental Health Access Coalition’s (known as BD SUMHAC) State Advocacy Program is dedicated to improving access to behavioral health treatment facilities for the bleeding disorders community across the nation by addressing the unique barriers present at the state level. Through this initiative, we partner with selected state teams to identify champions within state regulatory agencies, assess state-specific regulatory landscapes, and develop actionable next steps for advocacy.
Who Should Apply?
National Bleeding Disorders Foundation chapters or Hemophilia Federation of America member organizations partnering with Hemophilia Treatment Centers in states where individuals have been denied access to mental health or substance use disorder treatment facilities are eligible and encouraged to apply.
Apply here now!
Applications are due by Friday, December 6th.
What Have We Accomplished with the State Advocacy Program?
Launched in September 2023, BD SUMHAC’s State Advocacy Program began with participation from five state teams: Michigan, Minnesota, Montana, North Carolina, and Texas. Each team was led by advocates from local hemophilia treatment centers and bleeding disorder chapters. These teams have made incredible progress across the three core objectives:
- Engaged State Agencies: Each team identified at least one champion within a state agency who agreed to facilitate access for anyone with a bleeding disorder denied mental health (MH) or substance use disorder (SUD) treatment in their state.
- Mapped Regulatory Landscapes: Teams completely or partially mapped the regulatory landscapes of inpatient and residential MH and SUD facilities in their state.
- Determined Next Advocacy Steps: Teams developed actionable plans to address identified barriers.
We’re excited to build on this progress and expand impact through the 2025 State Advocacy Program!
Learn more about the work of the 2024 State Advocacy Program teams here.