By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (Odevixibat) Covered by Humana in Florida: Complete Prior Authorization & Appeals Guide

Answer Box: Quick Path to Bylvay Coverage

To get Bylvay (odevixibat) covered by Humana in Florida: Submit a prior authorization request with genetic confirmation of PFIC or Alagille syndrome, weight-based dosing calculations, and documented failure of standard therapies. Use ICD-10 codes Q44.7 (liver malformations) or K83.0 (cholangitis). If denied, you have 65 days to appeal. Start by having your prescriber complete Humana's PA form and submit via fax to 877-486-2621 or through their provider portal.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Essential ICD-10 Codes and Documentation
  4. Billing Codes: HCPCS, NDC, and Units Calculation
  5. Clean Prior Authorization Anatomy
  6. Common Denial Reasons and How to Fix Them
  7. Appeals Process in Florida
  8. Cost Assistance and Patient Support
  9. When to Contact Florida Regulators
  10. FAQ: Your Top Questions Answered

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required Must get approval before filling Humana PA Resources
Specialty Pharmacy Only Must use CenterWell or approved network CenterWell Specialty
Age Requirements ≥3 months (PFIC), ≥12 months (Alagille) FDA Bylvay Label
Genetic Confirmation Lab/genetic testing proving diagnosis Provider clinical documentation
Weight-Based Dosing Precise mg/kg calculations required FDA Dosing Guidelines
Step Therapy Prior treatment failures documented Humana clinical criteria

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis and Eligibility

  • Who: Your specialist (pediatric gastroenterologist/hepatologist)
  • What: Genetic testing confirming PFIC or Alagille syndrome
  • Timeline: Complete before PA submission

2. Gather Required Documentation

  • Who: Clinical team
  • What: Weight records, prior therapy documentation, pruritus severity scores
  • Timeline: 1-2 business days

3. Calculate Weight-Based Dosing

  • Who: Prescriber
  • What: Precise mg/kg/day calculation based on current weight
  • Timeline: Same day as prescription

4. Complete Humana PA Form

  • Who: Prescriber or authorized staff
  • What: Download form and complete all sections
  • Timeline: 24-48 hours for completion

5. Submit PA Request

  • Who: Provider office
  • How: Fax to 877-486-2621 or submit via provider portal
  • Timeline: Same business day

6. Follow Up on Decision

  • Who: Patient or provider
  • What: Check status after 72 hours (standard) or 24 hours (expedited)
  • Timeline: Within Humana's decision timeframes

7. Coordinate with Specialty Pharmacy

  • Who: Patient with CenterWell Specialty (1-800-486-2668)
  • What: Set up delivery and refill schedule
  • Timeline: 2-3 business days after approval

Essential ICD-10 Codes and Documentation

Primary ICD-10 Codes for Bylvay

Progressive Familial Intrahepatic Cholestasis (PFIC):

  • Q44.7 - Other congenital malformations of liver
  • K83.0 - Cholangitis
  • E80.6 - Other disorders of bilirubin metabolism

Alagille Syndrome:

  • Q44.7 - Other congenital malformations of liver
  • Q87.89 - Other specified congenital malformation syndromes

Required Clinical Documentation

Your prescriber must include:

  • Genetic test results confirming diagnosis
  • Current patient weight and calculated dosing
  • Pruritus severity assessment and impact on quality of life
  • Documentation of prior therapies tried and failed
  • Laboratory values (bilirubin, bile acids, liver function tests)
  • Specialist consultation notes supporting Bylvay therapy
Tip: Incomplete genetic documentation is the #1 reason for initial denials. Ensure genetic testing clearly confirms PFIC subtype or Alagille syndrome diagnosis.

Billing Codes: HCPCS, NDC, and Units Calculation

HCPCS/J-Code Information

Bylvay doesn't have a specific J-code. For medical benefit billing:

  • J8499 - Prescription drug, oral, non-chemotherapeutic, NOS

NDC Numbers by Strength

Bylvay NDC numbers are strength-specific. Common strengths include:

  • 200 mcg capsules
  • 400 mcg capsules
  • 1200 mcg capsules
Note: Always verify the exact NDC from your product packaging, as numbers can change with new lots or packaging updates.

Weight-Based Dosing Calculations

PFIC Dosing: 40-120 mcg/kg once daily Alagille Syndrome: 120 mcg/kg once daily

Example Calculation:

  • 20 kg child with PFIC
  • Starting dose: 40 mcg/kg = 800 mcg daily
  • Use 2 × 400 mcg capsules daily
  • 30-day supply = 60 capsules

Common billing errors include:

  • Incorrect weight documentation
  • Math errors in daily dose calculation
  • Wrong quantity for days supply
  • Missing weight in PA documentation

Clean Prior Authorization Anatomy

Essential PA Components

Patient Information Section:

  • Full name, DOB, Humana ID number
  • Current weight and date measured
  • Prescribing physician NPI and contact

Clinical Justification:

  • Primary diagnosis with ICD-10 code
  • Genetic test results and date
  • Prior therapies attempted with dates and outcomes
  • Current symptom severity and functional impact

Prescription Details:

  • Bylvay strength and daily dose
  • Quantity requested and days supply
  • Anticipated duration of therapy
  • Administration instructions

Supporting Documentation:

  • Recent lab results
  • Specialist consultation notes
  • Quality of life assessments
  • Photos/documentation of pruritus effects (if applicable)

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
Age below threshold Provide current weight/age verification Birth certificate, recent clinic visit
Lack of genetic confirmation Submit genetic test results Lab report with PFIC/ALGS confirmation
Insufficient prior therapy documentation Document all previous treatments Pharmacy records, prior prescription history
Incorrect dosing calculation Recalculate based on current weight Updated weight measurement, dosing worksheet
Non-formulary status Request formulary exception Medical necessity letter, alternative drug failures
Quantity limit exceeded Adjust quantity or request override Clinical justification for higher dose

Weight-Based Dosing Errors

The most common billing denial involves incorrect units calculation. Humana requires:

  • Current patient weight (within 30 days)
  • Exact mg/kg calculation shown
  • Daily dose and total monthly quantity matching
  • Clear documentation of dosing rationale

Appeals Process in Florida

Internal Appeal (Redetermination)

Timeline: 65 days from denial notice How to Submit:

  • Online: Humana member portal
  • Phone: Number on your denial letter
  • Mail: Address provided in denial notice
  • Fax: 877-486-2621

Required Documents:

  • Original denial letter
  • New medical evidence
  • Updated prescriber letter
  • Any additional clinical documentation

External Review in Florida

If Humana denies your internal appeal, Florida law provides external review rights:

Timeline: 4 months after final internal denial How to Request: Florida Department of Financial Services Cost: Free to consumers Decision: Binding on Humana

Expedited Reviews: Available for urgent medical situations with 72-hour decision timeline.

Important: Florida's external review process is handled by independent medical experts not affiliated with Humana. Success rates are higher when complete clinical documentation supports medical necessity.

Cost Assistance and Patient Support

Manufacturer Support

Ipsen Cares Program:

  • Copay assistance for eligible patients
  • Patient access support
  • Prior authorization assistance
  • Contact: IpsenCares.com

Additional Resources

  • Patient Advocate Foundation: Financial assistance for specialty medications
  • Florida KidCare: State program for children's health coverage
  • Medicaid: May provide secondary coverage for eligible patients

Annual Bylvay costs can range from $106,000 to over $500,000 depending on dosing, making manufacturer and foundation support crucial for most families.

When to Contact Florida Regulators

Contact the Florida Department of Financial Services if:

  • Humana fails to respond within required timeframes
  • You need help navigating the appeals process
  • You suspect unfair denial practices

Florida Insurance Consumer Helpline: 877-693-5236 Online Complaints: MyFloridaCFO.com

The state can facilitate communication with Humana and ensure you receive full appeal rights under Florida law.

FAQ: Your Top Questions Answered

Q: How long does Humana prior authorization take for Bylvay in Florida? A: Standard requests: 72 hours. Expedited requests: 24 hours if waiting could jeopardize health.

Q: What if Bylvay isn't on Humana's formulary? A: Request a formulary exception with your PA. Include detailed medical necessity documentation explaining why covered alternatives aren't appropriate.

Q: Can I get Bylvay from any pharmacy? A: No. Humana requires specialty medications like Bylvay to be dispensed through their specialty pharmacy network, typically CenterWell Specialty.

Q: What happens if my child's weight changes significantly? A: Contact your prescriber to recalculate dosing. Submit a new PA if the dose change exceeds Humana's quantity limits.

Q: Does step therapy apply if we tried other treatments outside Florida? A: Yes. Document all prior therapies regardless of where they were tried. Include pharmacy records and physician notes from previous states.

Q: How much will Bylvay cost with Humana coverage? A: Costs vary by plan. Specialty tier copays typically range from $100-500+ monthly. Check your specific plan's formulary for exact costs.

Q: Can I request an expedited appeal? A: Yes, if waiting for coverage could seriously jeopardize your health. Your doctor must certify the urgent medical need.

Q: What if Humana requires a peer-to-peer review? A: Your prescriber will discuss the case directly with Humana's medical director. Prepare clinical documentation and be ready to explain why Bylvay is medically necessary.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and doesn't constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. Always consult your healthcare provider and insurance plan documents for specific guidance. Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific criteria.

For additional help with insurance appeals in Florida, contact the Florida Department of Financial Services Consumer Helpline at 877-693-5236.

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