Advocacy and Legal Team – Legislative and Regulatory Updates
Appropriations Measure is Signed Into Law
by Artemis Policy Group
In early February, Congress passed and the President signed into law a package (the Consolidated Appropriations Act of 2026, or CAA 2026) that provides funding for the federal health agencies for the remainder of the fiscal year. The law includes continued level funding for the two hemophilia programs at the Centers for Disease Control and Prevention (CDC) and the hemophilia program at the Health Resources and Services Administration (HRSA).
The CAA 2026 contains a number of substantive health policies in addition to appropriations language. While a few of the new policies could be relevant to HTCs, none raise significant concerns for the Hemophilia Alliance or its members. The new policies include:
- PBM reform provisions (narrower than in past bills), including:
- With respect to Medicare Part D only – require PBMs to pass through certain rebates and discounts to plan sponsors, and allow PBM to charge only flat administrative fees for their services.
- Require PBMs to report at least annually to plan sponsors and HHS regarding contracts, rebates, drugs dispensed, use of copay assistance, etc.
- Require PBMs under contract with ERISA plans to pass through drug rebates to the plan issuers.
- The Accelerating Kids’ Access to Care Act – policy supported by the Hemophilia Alliance that makes it easier for children with Medicaid or CHIP coverage to access providers across state lines.
- Extension of current Medicare telehealth flexibilities until December 31, 2027.
- Assuring pharmacy access and choice (“any willing provider”) for Medicare beneficiaries.
- Requiring a separate identification number and an attestation for each off-campus outpatient department of a provider by 2028.
340B Reform Efforts Remain Quiet
The CAA 2026 – the likeliest vehicle for 340B reform efforts – contained no provisions aimed at 340B or covered entities. Oversight and legal wrangling, however, continue. On February 1st, Senator Cassidy (chair of the Senate Health, Education, Labor and Pensions Committee) sent a lengthy letter asking for detailed information from Apexus, the 340B prime vendor, about its revenue streams and business practices. Also in February, HRSA indicated it would once again explore a 340B rebate model (the agency abandoned an earlier proposed demonstration model following litigation initiated by hospitals).
eAPTC Extension Appears Dead
On January 8, the House of Representatives passed legislation which would extend the ACA enhanced tax credits for an additional three years. Senate negotiators, however, have been unable to reach agreement on a path forward to extend the enhanced tax credits. Lawmakers and Hill watchers alike believe there is little chance that any measure will be enacted.
Update on Medicare Reimbursement Issues for Some Bleeding Disorders Treatments
Last December’s newsletter reported that certain member HTCs had received denials from Medicare for claims relating to newer non-factor hemophilia treatments that are administered by injection (e.g., Hympavzi, Qfitlia, and Alhemo). The problem apparently arose because local MACs (Medicare Administrative Contractors, the entities that pay Part A and B claims), had not updated their Part B clotting factor billing and coding articles to include the new treatments.
CMS’s January 2026 updates to its Medicare Part B payment files will hopefully resolve this issue. The updated files reflect all the new hemophilia injectables as clotting factors. At least one MAC (Noridian) has updated its Hemophilia Clotting Factor Billing page to conform to the CMS payment files. Please reach out to your Hemophilia Alliance MCR team member if you are still encountering Medicare reimbursement issues for the new hemophilia products.
Have a story you want to share or a topic you would like us to cover?
Also In This Issue…
Jeff Weighs In
Member and Community Relations Update
- The MCR Team Is Here to Support Your HTC with Letters of Agreement, Single Case Agreements, and Gene Therapy Reimbursement
- Linda Gammage Social Worker Planning Committee Member Needed
- 5th Annual Pharmacist CE Meeting – The Best Yet!
Administration and Operations Update
- Annual Savings Letters and Member Dues – Be on the Lookout!
- MPBA 2026 Meeting Recap: Strengthening the Future of HTCs Through Leadership, Strategy, and Collaboration
Notes From The Community
- In Tribute to Dr. Lynn Malec
- Spring 340B Grantees Conference
- NBDF Issues Statement on Gene Therapy
- Central Virginia Center for Coagulation Disorders Offers New Clinic
- Tool for Pharmacies