Haystack Project: Access to Rare Indications Act

December 2021 - The Cutaneous Lymphoma Foundation is an active member of the Haystack Project, an umbrella nonprofit organization dedicated to supporting rare disease patient organizations in collaborating with stakeholders to find practical and impactful legislative solutions for rare disease patients. The Haystack Project has been advocating for the introduction of the Access to Rare Indications Act of 2021 to Congress. We were thrilled to learn that the Act was introduced by Reps. Doris Matsui, D-California, Mike Thompson, D-California, Mike Kelly, R-Pennsylvania and Markwayne Mulllin, R-Oklahoma in December.

The Access to Rare Indications Act of 2021 would require Medicare and Medicaid to cover a drug used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals if such use is supported by:

  • Peer-reviewed medical literature
  • Clinical guidelines
  • An expert in such a disease or condition as identified by a medical society involved in the treatment or management of such disease or condition
  • And is not reviewed unfavorable in the compendia or listed as a contraindication in the Food and Drug Administration-approved labelling

The bill would also require health insurance plans to provide an expedited mechanism for formulary exceptions, reconsideration and appeal of any coverage denial for off-label use of a drug for a rare disease patient that meets these criteria.

Why is this important? The bill reduces the initial and often extremely high hurdle for rare disease patients (like cutaneous lymphoma) to meet the medical necessity threshold for access and insurance coverage for off-label use of treatments.  

You can read more about the bill here.

The Haystack Project also continues to advocate for passage of the HEART Act (HR 1184). The HEART Act contains tangible and practical solutions for involving patients and rare disease experts in the FDA review process to better inform the review of drugs for safety and efficacy. 

Read more about the HEART Act.

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