AHDA Leads National Coalition Calling on CMS to Strengthen Prior Authorization and Step Therapy Protections
The Alliance for Headache Disorders Advocacy recently led a national coalition of headache, pain, and patient advocacy organizations in submitting comments to the Centers for Medicare & Medicaid Services urging stronger protections for people living with migraine, cluster headache, facial pain, and other disabling headache disorders.
The sign-on letter responded to CMS’s proposed rule addressing prior authorization for drugs, interoperability standards, transparency, and related reforms. While AHDA strongly supports CMS’s efforts to modernize prior authorization systems and improve access to information, the coalition urged the agency to go further by directly addressing step therapy, continuity of care, abrupt coverage changes, and the real-world burden these policies place on patients and clinicians.
For people living with headache disorders, delays in treatment are not minor administrative problems. A delayed preventive or acute therapy can mean additional attacks, worsening symptoms, missed work or school, inability to care for family members, avoidable emergency department visits, and a loss of stability that may have taken years to achieve.
Migraine alone affects approximately 39 to 40 million Americans. Despite this enormous burden, people living with migraine and other headache disorders routinely face prior authorization requirements, repeated reauthorizations, opaque step therapy rules, and sudden formulary changes that can interrupt care.
Prior authorization and step therapy are among the most common barriers reported by the headache community. Step therapy, sometimes called “fail first,” can require patients to try medications that are ineffective, poorly tolerated, contraindicated, or already unsuccessful before they can access the treatment recommended by their clinician.
The coalition urged CMS to treat step therapy as a central utilization management issue, not a secondary concern. In headache care, patients may be forced to cycle through multiple medications over months or years, even when their medical history clearly shows that a treatment has failed or is not appropriate. AHDA also emphasized that patients should not have to restart years of failed treatment history simply because they change jobs, change insurance plans, move states, age into Medicare, or experience another coverage transition.
A major focus of the letter was continuity of care for patients who are already stable on treatment. For people with chronic migraine, cluster headache, and other disabling headache disorders, stability can represent the difference between functioning in daily life and living with severe disability. When a plan changes its formulary, adds a new prior authorization requirement, or imposes a new step therapy rule, patients who had finally found an effective treatment can quickly lose access.
AHDA urged CMS to strengthen protections for stable patients by requiring plans to recognize prior approvals, streamline renewals when there has been no material clinical change, provide temporary continuation of coverage during appeals or transitions, and limit non-medical switching for chronic neurological diseases.
The coalition also called for stronger notice requirements when plans change coverage rules. Too often, clinicians and patients only discover that a medication is no longer covered or that new restrictions have been added when a prescription is rejected, treatment is delayed, or a patient arrives for care and learns that coverage has changed.
Advance notice of formulary changes, new prior authorization requirements, step edits, quantity limits, site-of-care restrictions, and other coverage changes would help clinicians and patients avoid surprise denials and prevent treatment disruptions.
The letter also highlighted the need for transparency tools that are actually usable. AHDA supports CMS’s proposal to improve access to prior authorization information through patient and provider application programming interfaces, known as APIs. But transparency only helps if the information is timely, clear, complete, and actionable. Patients and clinicians should be able to understand where a request stands, what documentation is missing, why a treatment was denied, and what steps are available next.
For people living with disabling headache disease, uncertainty itself can be harmful. Waiting weeks without knowing whether a treatment will be approved can lead to treatment gaps, stress, worsening symptoms, and additional administrative strain on already overburdened clinicians.
AHDA also urged CMS to ensure that coverage decisions reflect current clinical evidence and appropriate expertise. Headache medicine has changed significantly in recent years, with new preventive and acute treatments expanding options for patients who previously had few effective choices. Yet patients and clinicians continue to report denials based on outdated criteria or rigid requirements that do not reflect current standards of care or individualized medical need.
Physician-administered therapies were another important focus of the coalition’s comments. These treatments can be especially vulnerable to scheduling disruptions and authorization delays. When physician-administered therapies are delayed, patients may miss carefully timed treatment cycles, leading to symptom escalation and avoidable disability. These disruptions also create financial and operational challenges for practices, particularly when treatments are purchased in advance under buy-and-bill models.
Finally, AHDA called for meaningful public reporting of utilization management metrics. Patients should be able to compare plans not only by premiums and networks, but also by how often medically necessary care is delayed or denied. The coalition urged CMS to require reporting on approval and denial rates, appeal overturn rates, decision times, repeat authorization requirements, requests for additional documentation, and step therapy override approval rates.
The letter was signed by AHDA and a broad coalition of organizations committed to improving care for people living with headache disorders and chronic pain, including:
Alliance for Headache Disorders Advocacy
American Headache Society
Chronic Migraine Awareness
Clusterbusters, Inc.
Danielle Byron Henry Migraine Foundation
Facial Pain Association
Great Lakes Regional Headache Society
National Headache Foundation
Headache Cooperative of the Pacific
Miles for Migraine
U.S. Pain Foundation
This coalition effort reflects AHDA’s continued leadership in federal policy advocacy for people living with headache disorders. Prior authorization and step therapy reforms are not abstract policy issues for our community. They affect whether patients can work, attend school, care for loved ones, avoid emergency care, and maintain access to treatments that help them function.
AHDA will continue working to ensure that federal policy reflects the lived experience of people with migraine and headache disorders and reduces unnecessary barriers between patients and the care their clinicians recommend.