How to Get Tysabri (Natalizumab) Covered by Humana in California: Appeals, Forms & State Protections
Answer Box: Your Fastest Path to Tysabri Coverage
Getting Tysabri (natalizumab) covered by Humana in California requires completing the TOUCH program enrollment first, then submitting a prior authorization request with medical necessity documentation. If denied, California's Independent Medical Review (IMR) overturns specialty drug denials at high rates—up to 80% for medical necessity cases. Start today by: (1) Ensuring your prescriber is TOUCH-registered at TOUCHprogram.com, (2) Requesting Humana's coverage determination form via their provider portal, and (3) Gathering documentation of failed MS therapies or contraindications to formulary alternatives.
Table of Contents
- Why California State Rules Matter for Humana Coverage
- Turnaround Standards and Timelines
- Step Therapy Protections for MS Treatments
- Continuity of Care During Transitions
- External Review and Complaint Process
- Practical Scripts and Documentation
- Coverage Requirements at a Glance
- Appeals Playbook for Humana in California
- When to Escalate to State Regulators
- FAQ
Why California State Rules Matter for Humana Coverage
California's robust insurance regulations provide critical protections that work alongside Humana's Medicare Advantage and Part D policies. Unlike many states, California has two insurance regulators: the Department of Managed Health Care (DMHC) oversees most HMOs and managed care plans, while the California Department of Insurance handles other policies.
For Humana Medicare Advantage members, these state protections include automatic approval if the plan fails to respond within required timeframes, mandatory step therapy exceptions for medical necessity, and access to Independent Medical Review (IMR)—California's external review process with exceptionally high success rates for specialty drug appeals.
Key advantage: California law caps patient costs for appeals at zero—there's no fee to request an IMR, and insurers bear the cost of independent medical review.
Turnaround Standards and Timelines
California's prior authorization timeline requirements apply to all health plans, including Humana:
| Request Type | Standard Timeline | Expedited Timeline | Consequence of No Response |
|---|---|---|---|
| Non-urgent prior authorization | 72 hours | 24 hours (if prescriber certifies harm risk) | Deemed approved |
| Urgent services | 96 hours | 24 hours | Must provide care |
| Coverage determination appeals | 30 days | 72 hours | Escalates to external review |
For Tysabri specifically: Since this is an infusion therapy for progressive MS, most requests qualify for expedited review if your neurologist documents that treatment delays could worsen disability or increase relapse risk.
Tip: Request expedited review by having your prescriber check the "serious jeopardy" box on Humana's coverage determination form and provide a brief statement about MS progression risks.
Step Therapy Protections for MS Treatments
California's AB 347 (2021) requires health plans to grant step therapy exceptions for disease-modifying therapies when medical necessity criteria are met. For Tysabri, common override situations include:
- Failed first-line DMTs: Document inadequate response to interferons, glatiramer acetate, or oral DMTs after appropriate trial periods
- Intolerance to preferred drugs: Severe injection site reactions, flu-like symptoms, or liver enzyme elevation
- Clinical contraindications: Specific medical conditions that make formulary alternatives inappropriate
- Continuation therapy: Already stable on Tysabri with high risk if switched
Documentation requirements: Your neurologist must provide specific details about previous treatments, including drug names, dosages, duration of trials, and reasons for discontinuation. Generic statements like "patient failed other therapies" are insufficient.
Counterforce Health specializes in creating these evidence-backed step therapy exception requests, pulling the right clinical citations and aligning documentation to each plan's specific criteria to improve approval rates.
Continuity of Care During Transitions
If you're switching to a new Humana plan or transitioning from another insurer, California provides continuity protections:
- 90-day transition supply: New plans must provide temporary coverage for non-formulary drugs you're currently taking
- Ongoing therapy protection: Cannot be forced to switch if clinically stable on current treatment
- Grace period appeals: Extended time to complete prior authorization during plan transitions
For TOUCH program compliance: Ensure your enrollment transfers properly between plans. Contact Biogen's TOUCH program at 1-800-456-2255 to verify continuous enrollment during insurance transitions.
External Review and Complaint Process
California's Independent Medical Review (IMR) is your most powerful tool for overturning Humana denials. Recent data shows IMR overturns 68.6% of medical necessity denials and 49.1% of experimental/investigational denials for major insurers like Anthem Blue Cross.
IMR Process Steps:
- File internal appeal with Humana first (required)
- Wait 30 days or proceed immediately for urgent cases
- Submit IMR application at healthhelp.ca.gov or call 1-888-466-2219
- DMHC assigns independent review within 45 days (7 days for expedited)
- Plan must comply with IMR decision if overturned
Success factors: IMR reviewers are independent physicians in relevant specialties. Include complete medical records, failed therapy documentation, and current treatment goals in your submission.
Practical Scripts and Documentation
Patient Phone Script for Humana
"Hi, I need to request prior authorization for Tysabri, generic name natalizumab, for multiple sclerosis. My prescriber is enrolled in the TOUCH program. Can you send me the coverage determination form or direct me to submit this through your provider portal? I'd like to request expedited review since treatment delays could worsen my MS."
Medical Necessity Letter Checklist for Clinicians
- Problem statement: Specific MS subtype, EDSS score, relapse history
- Prior treatments: List all DMTs tried with dates, dosages, and outcomes
- Clinical rationale: Why Tysabri is medically necessary vs. formulary alternatives
- Guideline citations: Reference AAN guidelines, FDA labeling, or MS society recommendations
- Monitoring plan: PML risk mitigation, MRI schedule, JCV antibody testing
Coverage Requirements at a Glance
| Requirement | Details | Where to Verify | Source |
|---|---|---|---|
| Prior Authorization | Required for all Humana plans | Provider portal or 1-800-379-0092 | Humana Pharmacy |
| TOUCH Enrollment | Mandatory FDA requirement | TOUCHprogram.com | FDA REMS Program |
| Step Therapy | May apply; exceptions available | Coverage determination form | California AB 347 |
| Formulary Status | Varies by plan; exceptions possible | Plan formulary or member portal | Humana Member Services |
| Site of Care | Infusion center or physician office | Prior auth specifies location | Plan policy |
Appeals Playbook for Humana in California
Level 1: Internal Appeal (Redetermination)
- Timeline: 7 days standard, 72 hours expedited
- How to file: Humana member portal or call 1-800-833-2364
- Required: Original denial letter, additional medical records, prescriber statement
Level 2: Independent Review Entity (IRE)
- Timeline: 7 days standard, 72 hours expedited
- Automatic: Humana forwards if internal appeal denied
- Your role: Provide any additional documentation
Level 3: California IMR (if applicable)
- When available: Medical necessity or experimental/investigational denials
- File at: healthhelp.ca.gov or 1-888-466-2219
- Timeline: 45 days standard, 7 days expedited
- Cost: Free to patient
The specialized team at Counterforce Health can help navigate these multiple appeal levels, ensuring proper documentation and deadlines are met while you focus on your treatment.
When to Escalate to State Regulators
Contact the DMHC Help Center if Humana:
- Fails to respond within required timeframes
- Denies expedited review inappropriately
- Doesn't follow IMR decisions
- Creates barriers to TOUCH program compliance
DMHC Help Center: 1-888-466-2219 (TTY: 1-877-688-9891)
Email: [email protected]
Online: healthhelp.ca.gov
From our advocates: "We've seen cases where Humana initially denied Tysabri for 'not meeting step therapy,' but when the neurologist provided detailed documentation of three failed DMTs with specific side effects and efficacy measures, the internal appeal was approved within 48 hours. The key was quantifying the failures, not just listing them."
FAQ
How long does Humana prior authorization take for Tysabri in California?
Standard: 72 hours. Expedited: 24 hours if prescriber certifies medical urgency. California law deems requests approved if Humana doesn't respond within these timeframes.
What if Tysabri is non-formulary on my Humana plan?
You can request a formulary exception using Humana's coverage determination form. Include medical necessity documentation and prescriber statement explaining why formulary alternatives are inappropriate.
Can I get expedited appeals for MS treatments?
Yes. California allows expedited review if treatment delays could cause serious jeopardy to health, life, or ability to regain maximum function—which applies to MS progression risks.
Does TOUCH program enrollment affect insurance coverage?
TOUCH enrollment is required before any insurer will cover Tysabri. Complete enrollment at TOUCHprogram.com before submitting prior authorization requests.
What's the success rate for Tysabri appeals in California?
California's IMR data shows 68.6% success rate for overturning medical necessity denials, with additional cases resolved when plans reverse decisions before IMR completion.
How much will Tysabri cost with Humana coverage?
Costs vary by plan tier and site of care. Medicare Part D plans have different cost-sharing than Medicare Advantage. Check your specific plan's formulary for tier placement and copay amounts.
Sources & Further Reading
- Humana Prior Authorization Forms
- California DMHC Help Center
- IMR Application Portal
- TOUCH Program Enrollment
- Humana Member Services
- California Step Therapy Law (AB 347)
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific plan and individual circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official assistance with California insurance issues, contact the DMHC Help Center at 1-888-466-2219.
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