H.R. 5536 — HEADACHE Act

This section defines, for purposes of this Act, the term “headache disorder” as a primary or secondary medical condition for which headache is a principal symptom, including migraine, cluster headache, tension-type headache, spinal cerebrospinal fluid leak, idiopathic intracranial hypertension, new daily persistent headache, headache secondary to long COVID, orofacial pain disorders, post-traumatic headache secondary to traumatic brain injury, and headache disorders affecting vulnerable populations such as children, pregnant women, and older adults; and the term “Secretary” as the Secretary of Health and Human Services, except as otherwise provided.

This section establishes the National Headache Disorders Initiative (NHDI), requiring the Secretary of Health and Human Services to (1) implement a comprehensive program addressing the medical, societal, and economic impacts of headache disorders; (2) increase the clinical and research workforce for such patients; (3) coordinate with federal initiatives including the Helping to End Addiction Long-term (HEAL) Initiative, NIH Pain Consortium, Interagency Pain Research Coordinating Committee, and Centers of Excellence in Pain Education; (4) ensure federal resources for headache disorders research and services are commensurate with disease burden; (5) prioritize research to improve diagnosis and develop innovative therapeutics; (6) improve diagnosis protocols and care coordination, including for comorbidities; (7) enhance the epidemiological database on headache disorders to address disparities; (8) conduct social research and public awareness campaigns to reduce stigma; and (9) coordinate with international bodies. The section further requires the Secretary to oversee NHDI establishment and updates and to evaluate all related federal programs, including budget requests and approvals.

This section establishes an Advisory Council on Headache Disorders Research, Care, and Services to advise the Secretary of Health and Human Services on headache disorders. The council comprises at least one federal representative from each of 14 specified agencies or offices (i.e., NIH, Office of Research on Women’s Health, FDA, CMS, IHS, VA, DoD, CDC, AHRQ, PCORI, ARPA-H, NCCIH, Department of Education, and others) and 12 non-federal members, including patient advocates (one with migraine and one with non-migraine headache disorder), a caregiver of a child or adolescent with headache disorder, specified types of healthcare providers (i.e., MD/DO, advanced practice provider, behavioral health specialist, orofacial pain specialist, front-line provider, and researcher), and a representative of a nonprofit focused exclusively on headache disorders, with an emphasis on representatives from minority, disproportionately affected, and underrepresented communities. The council must meet quarterly for the first two years after establishment and at the Secretary’s discretion thereafter and must convene an annual meeting of federal and non-federal organizations on headache disorders research beginning two years after enactment; the council terminates on the sunset date specified in section 7.

This section requires the heads of federal agencies with data relating to headache disorders to share such data with the Secretary of Health and Human Services, upon request, to enable completion of the report required under section 6. The data-sharing includes standardized data collection across agencies and integration with non-Federal sources such as electronic health records, patient registries, and population health surveys.

This section directs the Secretary to submit an annual report to Congress evaluating federally funded efforts relating to headache disorders research, clinical care, and other treatment programs and their outcomes. The report must also include (1) an evaluation of program performance, mission, and purpose, including data on headache disparities across racial, ethnic, socioeconomic, and geographic lines; (2) recommendations for priority actions, including reducing the financial impact of headache disorders on Medicare and other federally funded programs, improving health outcomes by updating diagnostic protocols, improving access to care, and advancing therapeutic research, and strategies to increase public awareness and reduce stigma; and (3) an annually updated national plan addressing short-term and long-term objectives for addressing headache disorders.