By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (odevixibat) Covered by Humana in Virginia: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Bylvay (odevixibat) Covered by Humana in Virginia

Humana Medicare Advantage plans in Virginia typically cover Bylvay as a specialty Part D drug but require prior authorization. If denied, you have 65 days to file a Part D appeal (redetermination). Humana must respond within 7 days for standard appeals or 72 hours for expedited appeals. After exhausting Humana's internal appeals, Virginia's State Corporation Commission Bureau of Insurance provides external review within 45 days (or 72 hours for urgent cases). First step today: Have your pediatric gastroenterologist submit a prior authorization request through Humana's provider portal with detailed medical necessity documentation.

Table of Contents

  1. Understanding Humana's Coverage for Bylvay in Virginia
  2. Reading Your Denial Letter
  3. First-Level Appeal: Humana Redetermination
  4. Medical Necessity Letter Requirements
  5. Peer-to-Peer Review Strategy
  6. Virginia External Review Process
  7. Common Denial Reasons & Solutions
  8. Appeals Timeline & Forms
  9. Cost Assistance Programs
  10. When to Escalate to State Regulators

Understanding Humana's Coverage for Bylvay in Virginia

Bylvay (odevixibat) is an oral IBAT inhibitor used to treat cholestatic pruritus in patients with Progressive Familial Intrahepatic Cholestasis (PFIC) aged 3 months and older, and Alagille syndrome patients aged 12 months and older. With annual costs potentially exceeding $100,000, Humana applies strict utilization management.

Coverage Requirements at a Glance

Requirement Details Source
Prior Authorization Required for all Bylvay prescriptions Humana Provider Portal
Formulary Status Typically Tier 5 specialty or non-formulary Plan-specific formulary
Quantity Limits Weight-based dosing per FDA maximums FDA prescribing information
Age Requirements ≥3 months (PFIC), ≥12 months (Alagille) FDA label
Specialist Requirement Pediatric gastroenterologist/hepatologist Standard medical necessity
Appeal Deadline 65 days from denial notice Humana Appeals Process

Reading Your Denial Letter

When Humana denies Bylvay coverage, carefully review the "Notice of Denial of Medicare Prescription Drug Coverage" to understand:

Key Information to Extract:

  • Denial reason code (e.g., "not medically necessary," "prior authorization required," "step therapy not met")
  • Appeal deadline (65 days from the notice date)
  • Required documentation for appeals
  • Expedited review eligibility if delay could jeopardize health
Tip: Virginia law requires clear denial reasons. If the letter is unclear, call Humana member services at the number on your insurance card and request specific criteria that weren't met.

First-Level Appeal: Humana Redetermination

Step-by-Step Appeal Process

1. Gather Required Documents

  • Original denial letter
  • Complete medical records from pediatric GI specialist
  • Lab results (liver function, bile acids, fat-soluble vitamins)
  • Documentation of prior treatment failures
  • Growth charts and functional assessment scores

2. Complete Appeal Form Use Humana's "Request for Redetermination of Medicare Prescription Drug Denial" form, available through your member portal.

3. Submit Within 65 Days

  • Online: Through Humana member portal
  • Fax: Number provided on denial notice
  • Mail: Address specified in denial letter

4. Request Expedited Review if Appropriate If severe pruritus is causing skin breakdown, sleep deprivation, or failure to thrive, request expedited review. Include prescriber statement that delay could "seriously jeopardize life, health, or ability to regain maximum function."

Timeline Expectations

  • Standard appeals: 7 calendar days for Humana's decision
  • Expedited appeals: 72 hours for Humana's decision

Medical Necessity Letter Requirements

Your pediatric gastroenterologist should include these essential elements:

Diagnosis Documentation

  • PFIC: Genetic testing results, cholestatic pattern labs, exclusion of other causes
  • Alagille syndrome: Clinical criteria (≥3 of 5 features: cholestasis, cardiac anomalies, skeletal abnormalities, ocular findings, characteristic facies) and/or genetic confirmation

Severity and Functional Impact

  • Pruritus severity scores (0-10 scale) over 4+ weeks
  • Sleep disruption data (night awakenings, total sleep hours)
  • Physical findings (excoriations, lichenification, skin infections)
  • Functional impairment (school absences, developmental delays, family impact)

Prior Treatment Failures

Document at least two failed conventional therapies:

  • Ursodeoxycholic acid (dates, doses, response)
  • Cholestyramine or other bile acid sequestrants
  • Rifampin (if tried and failed/contraindicated)
  • Antihistamines (ineffective for cholestatic pruritus)

Clinical Rationale

  • Reference FDA approval for PFIC/Alagille pruritus
  • Cite clinical trial data showing pruritus reduction
  • Explain why formulary alternatives are inadequate
  • Address safety monitoring plan per prescribing information
Clinician Corner: Counterforce Health helps clinicians create evidence-backed appeals by analyzing denial letters, plan policies, and clinical guidelines to draft targeted rebuttals that address payers' specific concerns.

Peer-to-Peer Review Strategy

Requesting a Peer-to-Peer Call

Contact Humana provider services at 1-800-523-0023 to request a peer-to-peer review with the medical director who denied the case.

Call Preparation Checklist

  • Patient's complete clinical timeline
  • Humana's specific coverage criteria for Bylvay
  • FDA prescribing information key points
  • Pruritus severity documentation
  • Prior therapy failure details with specific dates and outcomes

Key Talking Points

  1. Frame the case: "Child with genetically confirmed PFIC/Alagille syndrome, severe refractory cholestatic pruritus causing documented functional impairment"
  2. Map to criteria: Address each coverage requirement systematically
  3. Emphasize urgency: Highlight risks of continued severe pruritus (infection, growth failure, potential earlier transplant need)
  4. Request specific outcome: "Will you overturn the denial based on this evidence?"

Virginia External Review Process

If Humana upholds the denial at all internal appeal levels, Virginia's State Corporation Commission Bureau of Insurance provides independent external review.

Eligibility Requirements

  • Completed Humana's internal appeals process (unless expedited)
  • Denial based on medical necessity, experimental/investigational status, or similar clinical judgment
  • Request filed within 120 days of final internal denial

Filing Process

  1. Complete Form 216-A (External Review Request) available from Virginia SCC
  2. Attach supporting documents:
    • Final denial letter from Humana
    • All appeal correspondence
    • Medical records and prescriber letters
    • Clinical studies supporting off-label use (if applicable)
  3. Submit to Virginia SCC Bureau of Insurance

Timeline

  • Standard review: Independent Review Organization (IRO) decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases
  • IRO decision is binding on Humana
Note: Virginia's external review is free to patients and has helped many families obtain coverage for specialty medications when internal appeals failed.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
"Not medically necessary" Provide detailed pruritus scores, functional impact documentation, and specialist letter emphasizing disease severity
"Step therapy not completed" Document specific failures/intolerances of ursodiol, cholestyramine, rifampin with dates and adverse effects
"Age below threshold" Confirm patient meets FDA age requirements: ≥3 months (PFIC), ≥12 months (Alagille)
"Lack of specialist diagnosis" Ensure prescription comes from pediatric gastroenterologist/hepatologist with clear diagnostic documentation
"Quantity limit exceeded" Provide weight-based dosing calculation showing compliance with FDA maximum mg/kg/day limits
"Experimental/investigational" Emphasize FDA approval for specific indication and cite pivotal clinical trial data

Appeals Timeline & Forms

Humana Internal Appeals

  • Level 1 Redetermination: 65-day deadline, 7-day standard response (72 hours expedited)
  • Level 2 Reconsideration: Follow instructions on Level 1 denial letter

Virginia External Review

  • Filing deadline: 120 days from final internal denial
  • IRO decision: 45 days standard, 72 hours expedited
  • Required form: Form 216-A

Federal Appeals (if external review denied)

  • Administrative Law Judge hearing
  • Medicare Appeals Council review
  • Federal district court (if dollar threshold met)

Cost Assistance Programs

While pursuing appeals, explore financial assistance:

Manufacturer Support

  • Ipsen Cares: Patient assistance program for eligible families
  • Copay assistance: May reduce out-of-pocket costs for commercially insured patients

Foundation Grants

  • Patient advocacy organizations often provide emergency grants for specialty medications
  • Disease-specific foundations may offer financial support for PFIC/Alagille families

When to Escalate to State Regulators

Contact Virginia's regulators if Humana:

  • Misses appeal deadlines
  • Fails to provide required notices
  • Denies coverage contrary to their own policies

Virginia State Corporation Commission

  • Consumer Services: 1-877-310-6560
  • External Review: File Form 216-A for independent review
  • Managed Care Ombudsman: Assists with HMO/managed care issues

FAQ

How long does Humana prior authorization take in Virginia? Standard PA decisions typically take 14 days, but expedited requests (when delay could harm health) must be decided within 72 hours.

What if Bylvay is not on Humana's formulary? Request a formulary exception with detailed medical necessity documentation. Non-formulary drugs can be covered when medically necessary and no suitable alternatives exist.

Can I request expedited appeal if my child has severe pruritus? Yes, if your prescriber certifies that waiting for standard review could seriously jeopardize your child's health due to severe symptoms, skin breakdown, or failure to thrive.

Does Virginia have special protections for rare disease medications? Virginia's external review process provides independent evaluation of medical necessity determinations, including for rare diseases like PFIC and Alagille syndrome.

What happens if I miss the 65-day appeal deadline? Contact Humana immediately to request good cause exception. Valid reasons include hospitalization, family emergency, or failure to receive proper notice.

When navigating complex specialty drug approvals, families often benefit from expert guidance. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies, crafting evidence-based medical necessity arguments, and ensuring all procedural requirements are met. Their platform helps patients and clinicians build stronger cases that address insurers' specific concerns while meeting tight deadlines.

From our advocates: We've seen families succeed with Bylvay appeals by focusing on three key elements: comprehensive pruritus documentation (daily logs showing severity and sleep impact), clear evidence of conventional therapy failures with specific dates and reasons, and strong specialist letters that directly address the insurer's coverage criteria. While outcomes vary, thorough preparation significantly improves approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific guidance regarding your situation. For additional support with insurance appeals in Virginia, contact the Virginia State Corporation Commission Bureau of Insurance Consumer Services at 1-877-310-6560.

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