CMS Prior Authorization Reform Public Comment Toolkit
Help CMS Understand the Real-World Burden of Prior Authorization for Migraine Patients
The Centers for Medicare & Medicaid Services (CMS) has opened a major public comment period on its proposed rule to improve prior authorization for drugs, including physician-administered and pharmacy benefit medications. This is a critical opportunity for migraine patients, caregivers, and clinicians to tell CMS how prior authorization (PA), step therapy, and outdated coverage policies delay care and worsen outcomes.
Although this rule directly applies to Medicare, Medicaid, and CHIP beneficiaries, CMS policy changes often shape the broader insurance landscape, with commercial and employer-sponsored plans frequently following CMS’s lead.
CMS is proposing faster decisions (24 hours for urgent requests and 72 hours for standard requests), expanded electronic prior authorization, clearer denial explanations, and more transparency from health plans.CMS is also specifically asking for public input on step therapy and how prior payer determinations should be handled when patients change plans. Public comments are open through June 15, 2026.
For people living with migraine and other headache disorders, this is an important opportunity to explain how prior authorization, repeat reauthorization, step therapy, and insurance-driven treatment disruption affect real lives and patient care. The Alliance for Headache Disorders Advocacy has developed this toolkit to help patients, clinicians, researchers, caregivers and allies to develop their own comments to CMS on this important proposed rule.
Why This Matters for the Headache Community
Migraine care is frequently disrupted by:
- Repeated prior authorization requirements for proven therapies
- Fail-first/step therapy policies requiring patients to try and fail outdated or inappropriate medications first
- Delays for physician-administered treatments like infusion therapies and in-office procedures
- Coverage denials based on outdated payer criteria rather than current medical society guidelines
- Administrative burdens on neurologists and headache specialists that reduce patient access
CMS specifically states that patients “should not have to wait days or weeks” for approval to start prescribed medication and aims to replace “fax machines and fragmented systems with real-time electronic workflows.”
Your story can help ensure the final rule reflects the realities of migraine care and treatment.
Who Should Submit Comments?
Patients, caregivers, clinicians, researchers and patient advocacy groups should submit comments to help CMS understand the impact on their communities.
Note: you do not have to be a Medicare, Medicaid, or CHIP beneficiary to make a public comment.
Please write in your own words. Unique comments based on real experience are much more useful than templated language.
A strong comment usually includes:
- who you are,
- how prior authorization or step therapy has affected you, your patients, or your organization,
- one or two specific examples,
- what parts of the proposal you support,
- what CMS should strengthen or clarify in the final rule, and
- a short closing request.
You do not need to write a long comment. Even a few paragraphs can be valuable if they are specific and personal.
How to Structure Your Comment
1. Introduce yourself
Briefly explain who you are.
Examples:
- I am a person living with migraine/cluster headache/trigeminal neuralgia/etc.
- I am a caregiver for someone with a disabling headache disorder.
- I am a clinician who treats patients with migraine and other headache disorders.
- I am writing on behalf of an organization that serves people living with headache disorders.
2. Explain what happened
Describe your experience with prior authorization, repeat reauthorization, step therapy, or treatment disruption.
You might mention:
- delays in starting treatment
- repeated prior authorization for treatment that was already working
- forced medication switches
- needing to retry medications that had already failed
- difficulty accessing physician-administered treatment
- time spent on paperwork, calls, appeals, or record gathering
- worsening symptoms, missed work, missed school, caregiving disruption, or loss of function
3. Connect your experience to the rule
Explain which parts of the rule matter most to you.
Examples:
- faster decision timeframes matter because delays are harmful
- denial reasons should be clear and accessible
- electronic access to prior authorization status could reduce confusion and delay
- plans should recognize prior step therapy determinations when a patient changes coverage
- patients who are stable on treatment should not be forced to start over because of insurance churn
- public reporting of approvals, denials, appeals, and review times is important for accountability
Key Messages to Consider Including
1. Prior Authorization Delays Harm Migraine Patients
Explain how delays in treatment led to:
- more migraine days
- missed work or school
- reduced quality of life
- ER visits or urgent care
- progression to chronic migraine
- worsening depression, anxiety, or disability
Example:
“My patient was stable on therapy but experienced a lapse in treatment because prior authorization had to be resubmitted. This led to weeks of worsening migraine attacks and an avoidable emergency department visit.”
2. Step Therapy Is Part of the Prior Authorization Burden
Step therapy (or, “fail first”) forces patients to try medications that may be ineffective, poorly tolerated, or medically inappropriate. Forcing patients to step through three or four medications is a form of burdensome prior authorization.
CMS should recognize step therapy as part of the broader prior authorization burden and reduce unnecessary fail-first requirements.
Ask CMS to:
- limit repeated fail-first requirements
- prevent forced switching from stable therapy
- allow timely specialist override processes
- recognize prior treatment failures across plans
- recognize prior payer step therapy determinations when a patient changes coverage
- reduce the need to repeatedly prove past medication history
3. Coverage Decisions Should Reflect Current Medical Guidance
Health plans often use outdated criteria that do not reflect current headache medicine standards.
CMS should require plans to align Prior Authorization criteria with updated evidence-based guidance from medical societies such as:
- American Headache Society
- American Academy of Neurology
Ask CMS to:
- require use of updated specialty guidelines
- reduce denials based on obsolete criteria
- ensure clinical reviewers have appropriate specialty expertise
4. Physician-Administered Therapies Need Better Access Protections
Many migraine treatments are administered in-office and face especially burdensome authorization pathways.
This includes:
- infusion therapies
- injectable preventive treatments
- in-office procedures like chronic migraine treatment with onabotulinumtoxinA
- treatments billed under the medical benefit rather than pharmacy benefit
Electronic prior authorization, timely decisions, and continuity protections are especially important for these therapies because scheduling delays can disrupt care for weeks or months.
Commenters may wish to ask CMS to:
- streamline authorization for physician-administered therapies
- reduce repeated approvals for stable patients
- improve coordination between medical and pharmacy benefit systems
- ensure timely decisions so treatment schedules are not missed
5. Patients and Clinicians Need Advance Notice of Coverage Rule Changes
Patients and providers are too often blindsided by changes to formularies, prior authorization rules, step therapy criteria, quantity limits, or preferred products.
These changes may only become visible when:
- a prescription rejects at the pharmacy
- a scheduled treatment is delayed
- staff must urgently resubmit paperwork
- a patient loses access unexpectedly
Commenters may wish to ask CMS to require plans to provide timely notice to affected in-network clinicians and practices whenever material coverage rules change.
Possible recommendations include:
- electronic notice of major changes
- notice within a set number of business days after finalization
- advance notice before implementation whenever feasible
- clear explanation of what changed and when it takes effect
This would help reduce treatment disruption, administrative waste, and surprise denials.
6. Transparency and Accountability Matter
Patients often do not know how often treatments are denied, delayed, or overturned on appeal.
Commenters may wish to support public reporting of prior authorization metrics and encourage CMS to make this information understandable and accessible.
Important metrics include:
- approval and denial rates
- appeal outcomes
- average decision times
- frequency of extended review timeframes
- variation across plans and drug classes
Transparency can help identify patterns that harm patients and delay care.
How to submit a comment
Comments on CMS-0062-P are due by June 15, 2026. The Federal Register page links directly to the submission form and to Regulations.gov. The docket on the Federal Register page shows the comment deadline and provides the “Submit a public comment” option.
Suggested steps:
- Go to the Federal Register page for CMS-0062-P.
- Click “Submit a public comment.”
- Choose whether you are commenting as an individual, organization, or anonymously.
- Write your comment in your own words or upload it as a file.
- Include “CMS-0062-P” in your comment.
- Review carefully before submitting.
- Remember that comments are public, so do not include personal information you do not want posted online.
Report Back to Alliance for Headache Disorders Advocacy
Once you complete your public comment submission, please head to our report-back form to let us know you’ve submitted your comment. AHDA would like to track how many comments the migraine and headache disorder community submits to CMS.