By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by Humana in Pennsylvania: Appeals Guide with Templates

Quick Answer: Getting Tysabri Covered by Humana in Pennsylvania

If Humana denied your Tysabri (natalizumab) coverage, you have options. First step: Ensure TOUCH program enrollment for both patient and prescriber—this is mandatory. Fastest path: Submit a formulary exception with medical necessity documentation showing failed DMTs and contraindications to alternatives. Pennsylvania advantage: After internal appeals, you can request external review through the state's Independent External Review Program, which overturns about 50% of denials. Start with Humana's internal appeal within 60 days of your denial letter.

Table of Contents

  1. Understanding Your Denial
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Playbook for Humana in Pennsylvania
  6. Medical Necessity Letter Template
  7. External Review Process in Pennsylvania
  8. Costs & Patient Assistance Programs
  9. When to Escalate
  10. Frequently Asked Questions

Understanding Your Denial

When Humana denies Tysabri coverage, the reason typically falls into one of several categories. Read your denial letter carefully—it contains crucial deadlines and specific denial codes that determine your next steps.

Most Tysabri denials stem from:

  • Missing TOUCH program enrollment documentation
  • Inadequate documentation of prior treatment failures
  • Step therapy requirements not met
  • Non-formulary status requiring exception
  • Quantity or frequency limits exceeded
Note: Tysabri requires enrollment in the TOUCH Prescribing Program due to PML (progressive multifocal leukoencephalopathy) risk. Both prescriber and patient must be enrolled before coverage approval.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Tysabri prescriptions Humana provider portal Humana PA Requirements
TOUCH Enrollment Mandatory REMS program participation Prescriber must enroll at TOUCH portal FDA REMS Information
Step Therapy May require trying preferred DMTs first Plan formulary document Humana Formulary
Medical Necessity Documentation of MS diagnosis and treatment history Clinical notes and MRI results Medicare Part D Manual
JCV Antibody Testing Required for PML risk assessment Lab results within 6 months Tysabri prescribing information

Step-by-Step: Fastest Path to Approval

1. Verify TOUCH Enrollment (Patient & Prescriber)

  • Who does it: Your neurologist's office
  • Document needed: TOUCH enrollment confirmation
  • Timeline: Complete before PA submission
  • Source: Tysabri TOUCH Program

2. Gather Medical Documentation

  • Who does it: Patient coordinates with clinic
  • Documents needed: MS diagnosis, prior DMT trials/failures, MRI results, JCV status
  • Timeline: Allow 1-2 weeks for records compilation
  • Submit via: Humana provider portal or fax

3. Submit Prior Authorization Request

  • Who does it: Prescribing neurologist
  • Form needed: Humana PA form with medical necessity letter
  • Timeline: 72-hour standard review, 24-hour expedited
  • Portal: Humana provider services (verify current link)

4. If Denied: File Internal Appeal

  • Who does it: Patient or prescriber
  • Document needed: Appeal letter with additional evidence
  • Timeline: 60 days from denial date
  • Submit via: Humana member services or provider portal

5. Request Peer-to-Peer Review

  • Who does it: Prescribing neurologist
  • Action needed: Schedule call with Humana medical director
  • Timeline: Within appeal timeframe
  • Contact: Number provided in denial letter

6. External Review (If Internal Appeal Fails)

  • Who does it: Patient
  • Authority: Pennsylvania Insurance Department
  • Timeline: 4 months from final denial
  • Success rate: Approximately 50% overturn rate

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
TOUCH enrollment missing Submit enrollment confirmation TOUCH program certificates for patient and prescriber
Insufficient prior therapy Document failed DMTs with dates, doses, outcomes Treatment timeline with specific failure reasons
Non-formulary drug Request formulary exception Medical necessity letter explaining why alternatives won't work
Step therapy not met Show contraindications or failures with preferred agents Clinical notes documenting adverse effects or lack of efficacy
Quantity limits exceeded Justify dosing frequency FDA labeling and clinical guidelines supporting q4w dosing

Appeals Playbook for Humana in Pennsylvania

Internal Appeals Process

Level 1: Standard Reconsideration

  • Deadline: 60 days from denial letter date
  • Timeline: 30 days for medical benefit decisions, 7 days for Part D
  • Submit to: Humana member services (address on denial letter)
  • Required: Appeal letter, additional medical evidence, prescriber support

Level 2: Independent Review Entity (IRE)

  • Applies to: Medicare Advantage plans only
  • Timeline: Automatic if Level 1 upheld
  • Authority: MAXIMUS Federal Services
  • Patient action: None required—automatic escalation
Important: Pennsylvania's state external review process does not apply to Medicare Advantage plans like Humana. Medicare appeals follow federal rules, not state procedures.

Expedited Appeals

Available when delay could seriously jeopardize health:

  • Timeline: 72 hours for medical benefit, 24 hours for Part D
  • Trigger: Mark request as "expedited" with clinical justification
  • Documentation: Physician certification of urgent need

Medical Necessity Letter Template

[Date]
Humana Medicare Advantage
[Address from denial letter]

Re: Appeal for Coverage of Tysabri (natalizumab)
Member: [Patient Name], DOB: [Date]
Member ID: [ID Number]
Claim #: [If applicable]

Dear Medical Director,

I am appealing the denial of coverage for Tysabri (natalizumab) for my patient diagnosed with relapsing-remitting multiple sclerosis (ICD-10: G35).

CLINICAL BACKGROUND:
[Patient Name] was diagnosed with MS on [date] based on McDonald criteria, with MRI evidence of CNS demyelination and clinical relapses. Despite treatment with the following disease-modifying therapies, the patient continues to experience breakthrough disease activity:

• [Drug 1]: [Dates], discontinued due to [specific reason - adverse effects/lack of efficacy]
• [Drug 2]: [Dates], discontinued due to [specific reason]

MEDICAL NECESSITY FOR TYSABRI:
Recent MRI ([date]) shows [specific findings: new lesions/gadolinium enhancement]. Patient has experienced [number] relapses in the past [timeframe], significantly impacting functional status.

Tysabri is appropriate because:
1. FDA-approved for relapsing MS with proven efficacy in reducing relapse rates by 68%
2. Patient has failed/cannot tolerate preferred formulary alternatives
3. JCV antibody status: [positive/negative] - appropriate monitoring plan in place
4. Both patient and prescriber enrolled in TOUCH program (enrollment #[numbers])

SUPPORTING EVIDENCE:
• MRI reports demonstrating active disease
• TOUCH program enrollment confirmations
• Documentation of prior treatment failures
• JCV antibody test results

I respectfully request reconsideration of this denial. Tysabri represents the most appropriate therapeutic option for this patient's aggressive MS.

Sincerely,
[Neurologist name and credentials]
[Contact information]

External Review Process in Pennsylvania

Important Limitation: Pennsylvania's Independent External Review Program applies to commercial insurance plans, not Medicare Advantage. Humana Medicare Advantage appeals follow federal Medicare rules exclusively.

For non-Medicare Humana plans in Pennsylvania:

  • Authority: Pennsylvania Insurance Department
  • Timeline: 4 months to request after final internal denial
  • Success rate: Approximately 50% of appeals overturned
  • Submit via: PA.gov external review portal

Costs & Patient Assistance Programs

Biogen Patient Support Program

  • Copay assistance: Up to $20,000 annually for eligible patients
  • Eligibility: Commercial insurance, income limits apply
  • Apply: Tysabri Above MS program

Medicare Coverage

  • Part B vs Part D: Tysabri typically covered under Part B (medical benefit) when administered in clinical settings
  • Cost-sharing: 20% coinsurance after deductible for Part B coverage
From our advocates: "We've seen success when patients coordinate between their neurologist's financial counselor and Humana's case management team early in the process. Having both the TOUCH enrollment and a detailed treatment timeline ready before the initial PA request can prevent common delays that lead to denials."

When to Escalate

File a Complaint if:

  • Appeals deadlines aren't met by Humana
  • Required forms aren't provided
  • Peer-to-peer reviews are improperly conducted

Pennsylvania Insurance Department

Medicare Complaints

  • Phone: 1-800-MEDICARE (1-800-633-4227)
  • Online: Medicare.gov complaint portal
  • For: Medicare Advantage plan issues

Frequently Asked Questions

How long does Humana prior authorization take in Pennsylvania? Standard reviews take 72 hours for medical benefit drugs like Tysabri. Expedited reviews are completed within 24 hours when urgent medical need is documented.

What if Tysabri is non-formulary on my Humana plan? Request a formulary exception by submitting medical necessity documentation showing why preferred alternatives are inappropriate or ineffective for your condition.

Can I request an expedited appeal? Yes, if delay in treatment could seriously jeopardize your health. Your neurologist must provide clinical justification for expedited processing.

Does step therapy apply if I've tried DMTs outside Pennsylvania? Yes, document all prior treatments regardless of location. Humana recognizes treatment history from any licensed provider with proper documentation.

What happens if my appeal is denied? For Medicare Advantage, appeals automatically escalate to an Independent Review Entity. For commercial plans, you may be eligible for Pennsylvania's external review process.

How do I prove medical necessity for Tysabri? Provide MS diagnosis confirmation, documentation of prior DMT failures or contraindications, recent MRI results showing active disease, and TOUCH program enrollment proof.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies specific policy requirements, and generates evidence-backed appeal letters that address each payer's unique criteria. For complex cases like Tysabri appeals, we help ensure all required documentation—from TOUCH enrollment to medical necessity evidence—is properly formatted and submitted.

Sources & Further Reading

This guide provides educational information and is not medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For personalized assistance with appeals in Pennsylvania, contact the Pennsylvania Insurance Department at 1-877-881-6388 or visit pa.gov.

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