By Counterforce Health Team in Tysabri (natalizumab) —

How to Get Tysabri (Natalizumab) Covered by Humana in Virginia: Complete Guide with Forms and Appeals

Answer Box: Getting Tysabri Covered by Humana in Virginia

Tysabri (natalizumab) requires prior authorization from Humana and is typically placed on Tier 4 (Specialty) with 25-33% coinsurance. The fastest path to approval: Have your doctor submit a PA request with TOUCH program enrollment, JCV antibody results, and documentation of inadequate response to preferred MS therapies. If denied, you have 65 days to appeal internally and 120 days for Virginia external review through the State Corporation Commission. Start today by calling Humana at 1-800-555-2546 to confirm PA requirements.

Table of Contents

  1. Coverage Overview: What You Need to Know
  2. Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process for Virginia Residents
  6. Costs and Financial Assistance
  7. When to Escalate to Virginia Regulators
  8. Frequently Asked Questions

Coverage Overview: What You Need to Know

Tysabri (natalizumab) is a specialty infusion medication used to treat relapsing forms of multiple sclerosis and moderately to severely active Crohn's disease. Humana classifies Tysabri as a Tier 4 specialty drug, which means it requires prior authorization and carries the highest cost-sharing—typically 25-33% coinsurance during the coverage gap phase.

Coverage at a Glance

Requirement Details Where to Verify Source
Prior Authorization Required Humana provider portal Humana PA Lists
Formulary Tier Tier 4 (Specialty) Member drug list search Humana Drug Lists
Medical vs. Pharmacy Part B (Medical) Billing code J2323 Buy and Bill Guide
TOUCH Enrollment Mandatory (PML risk) Prescriber must enroll Tysabri REMS
Site of Care Infusion center/clinic Buy-and-bill model Tysabri Reimbursement
Note: Tysabri falls under Medicare Part B (medical benefit) rather than Part D (pharmacy benefit) because it's administered as an infusion in medical settings.

Prior Authorization Requirements

Humana requires comprehensive documentation for Tysabri approval. Your healthcare provider must submit evidence that meets specific medical necessity criteria.

Required Documentation Checklist

Clinical Information:

  • Confirmed diagnosis with appropriate ICD-10 codes:
    • Multiple Sclerosis: G35 (unspecified), G35.A (relapsing-remitting), G35.C1 (active secondary progressive)
    • Crohn's Disease: K50.90 (unspecified), K50.XX (specific location codes)
  • JCV antibody status (required for PML risk assessment)
  • MRI results showing active disease or progression
  • Documentation of inadequate response to preferred therapies

TOUCH Program Requirements:

  • Prescriber enrollment in TOUCH program
  • Patient enrollment and education completion
  • Baseline laboratory values (CBC, liver function, JCV antibody)

Treatment History:

  • Failed trials of preferred alternatives (step therapy documentation)
  • Contraindications to first-line therapies
  • Previous treatment responses and side effects

How to Submit Prior Authorization

For Providers:

  • Online: Humana provider portal
  • Phone: 1-800-555-CLIN (2546), Monday-Friday 8 AM-8 PM
  • Fax: 888-447-3430

For Patients: Contact your prescribing physician to initiate the PA request. You can also call Humana member services to check the status of pending requests.

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Benefits

Who: Patient or clinic staff
Action: Call Humana at 1-800-555-2546 to confirm Tysabri is on your plan's formulary
Timeline: Same day
Documents: Insurance card, member ID

2. Complete TOUCH Program Enrollment

Who: Prescriber and patient
Action: Enroll in mandatory TOUCH program through Biogen
Timeline: 1-2 business days
Documents: Prescriber license, patient consent forms

3. Gather Required Lab Results

Who: Healthcare provider
Action: Order JCV antibody test, baseline CBC, liver function tests
Timeline: 3-5 days for results
Documents: Lab reports with reference ranges

4. Document Step Therapy Failures

Who: Healthcare provider
Action: Compile records of previous MS treatments and outcomes
Timeline: Same day (if records available)
Documents: Treatment history, response documentation

5. Submit Prior Authorization Request

Who: Healthcare provider
Action: Submit complete PA packet via Humana provider portal
Timeline: Submit within 1 business day of gathering documents
Documents: PA form, clinical notes, lab results, TOUCH enrollment

6. Follow Up on Decision

Who: Patient or clinic staff
Action: Call Humana to check status if no response in 7 days
Timeline: Standard decisions within 14 days
Documents: PA reference number

7. Appeal if Denied

Who: Patient with provider support
Action: File internal appeal within 65 days of denial notice
Timeline: Must file within 65 days
Documents: Denial letter, additional clinical evidence

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Missing TOUCH enrollment Complete enrollment before resubmission TOUCH confirmation number
Inadequate step therapy documentation Provide detailed trial/failure history Treatment records, response notes
Insufficient JCV testing Submit current JCV antibody results Lab report within 6 months
Non-formulary status Request formulary exception Medical necessity letter
Quantity limits exceeded Justify dosing frequency Clinical rationale for q4w dosing
Site of care restriction Confirm infusion center approval Facility accreditation

Medical Necessity Letter Checklist

When appealing a denial, your physician should include:

  • Problem statement: Specific MS subtype or Crohn's severity
  • Prior treatments: List of failed therapies with dates and outcomes
  • Clinical rationale: Why Tysabri is medically necessary
  • Guideline support: Reference to MS or IBD treatment guidelines
  • Monitoring plan: JCV testing schedule and safety protocols
From our advocates: We've seen successful appeals when physicians include specific MRI findings showing disease progression despite prior treatments. One composite case involved a patient whose appeal was approved after the neurologist detailed three failed DMTs with documented side effects, supported by comparative MRI scans showing new lesions.

Appeals Process for Virginia Residents

If Humana denies your Tysabri request, Virginia residents have strong appeal rights through both internal and external review processes.

Internal Appeals (First Step)

  • Deadline: 65 days from denial notice
  • How to file: Call Humana member services or submit written appeal
  • Timeline: Standard review within 30 days, expedited within 72 hours
  • Required: Denial letter, additional medical evidence

External Review (Virginia State Process)

If internal appeals fail, Virginia's State Corporation Commission Bureau of Insurance provides independent review.

Eligibility Requirements:

  • Completed Humana's internal appeal process
  • Medical necessity or experimental treatment denial
  • Virginia-issued plan or opted-in self-funded plan

Filing Process:

  1. Download Form 216-A from Virginia SCC website
  2. Submit within 120 days of final internal denial
  3. Mail to: Virginia SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218 (verify current address)
  4. Include: Denial notices, medical records, Form 216-A

Timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours (if delay risks serious harm)
  • IRO assignment: Within 1 business day of eligibility confirmation

Contact Information:

  • Phone: (804) 371-9747
  • Consumer Services: 1-877-310-6560

The external review decision is final and binding on Humana. If overturned, Humana must authorize coverage within 24 hours for expedited reviews.

Counterforce Health helps patients navigate these complex appeals by analyzing denial letters and crafting evidence-based rebuttals that address specific payer criteria. Their platform can identify the exact denial basis and generate targeted appeals that speak directly to Humana's policies.

Costs and Financial Assistance

Humana Cost-Sharing

  • Tier 4 Specialty: 25-33% coinsurance
  • Typical cost: $1,500-2,500 per infusion (patient portion)
  • Annual out-of-pocket maximum: Varies by plan ($8,300-8,850 for 2024)

Financial Assistance Options

Biogen Support Programs:

  • Above MS: Copay assistance and financial counseling
  • Eligibility: Commercial insurance patients
  • Savings: Up to $15,000 annually

Medicare Patients:

  • Extra Help (LIS): Low-income subsidy program
  • State Pharmaceutical Assistance Programs: Virginia residents may qualify for additional support

Foundation Grants:

  • National MS Society: Financial assistance programs
  • Patient Advocate Foundation: Copay relief fund

When to Escalate to Virginia Regulators

Contact Virginia's Bureau of Insurance if you experience:

  • Unreasonable delays in prior authorization decisions
  • Failure to follow proper appeal procedures
  • Denial of medically necessary treatment
  • Discrimination based on disability

Virginia Bureau of Insurance:

  • Consumer Services: 1-877-310-6560
  • Website: scc.virginia.gov
  • Managed Care Ombudsman: Available for HMO issues

The Bureau can provide guidance on your rights and may informally resolve issues before formal external review.

For patients navigating complex denials, Counterforce Health specializes in turning insurance denials into successful appeals by identifying specific payer requirements and generating evidence-backed rebuttals tailored to each plan's policies.

Frequently Asked Questions

How long does Humana prior authorization take for Tysabri? Standard PA decisions are typically made within 14 days. Expedited reviews (for urgent medical needs) are decided within 72 hours.

What if Tysabri is not on Humana's formulary? You can request a formulary exception by submitting medical necessity documentation showing why covered alternatives are inappropriate.

Can I get expedited appeals in Virginia? Yes, if your doctor certifies that waiting could seriously jeopardize your health. Expedited external reviews are decided within 72 hours.

Does step therapy apply if I tried other drugs outside Virginia? Yes, treatment history from other states counts toward step therapy requirements. Ensure your provider submits complete documentation.

What happens if I miss the 65-day appeal deadline? Contact Humana immediately to request an extension. You may be able to demonstrate good cause for the delay.

Are there alternatives if all appeals fail? Consider the Tysabri patient assistance program, clinical trials, or switching to a different insurance plan during open enrollment.

How much does Tysabri cost without insurance? The wholesale acquisition cost is approximately $6,000-8,000 per infusion, making financial assistance crucial for uninsured patients.

Can I switch from Tysabri to the biosimilar Tyruko? Tyruko (natalizumab-sztn) may have different coverage requirements. Check with Humana about formulary placement and PA criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals and coverage issues, contact Virginia's Bureau of Insurance at 1-877-310-6560.

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