By Counterforce Health Team in Bylvay (odevixibat) —

How to Get Bylvay (Odevixibat) Covered by Blue Cross Blue Shield in Georgia: ICD-10 Codes, Prior Authorization Forms, and Appeals Timeline

Answer Box: Getting Bylvay Covered in Georgia

Bylvay (odevixibat) requires prior authorization from Blue Cross Blue Shield in Georgia and must be dispensed through specialty pharmacy. Key steps: 1) Submit PA request via Availity with ICD-10 code Q44.71 (Alagille syndrome) or cholestasis codes for PFIC, genetic testing results, and failed alternative therapies documentation. 2) Use HCPCS code J8499 for billing. 3) If denied, file internal appeal within 180 days, then external review with Georgia DOI within 60 days. Submit PA via Anthem provider portal.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Bylvay falls under the specialty pharmacy benefit for most Blue Cross Blue Shield plans in Georgia. This means it requires:

  • Prior authorization through the pharmacy benefit (not medical)
  • Dispensing via designated specialty pharmacies
  • HCPCS coding rather than traditional medical procedure codes
Tip: Always verify benefit coverage first. Some rare disease medications may be covered under the medical benefit if administered in clinical settings, but Bylvay is oral and self-administered.

ICD-10 Mapping for PFIC and Alagille Syndrome

Primary Diagnosis Codes

Condition ICD-10 Code Documentation Requirements
Alagille syndrome Q44.71 Genetic testing (JAG1/NOTCH2 mutations), liver biopsy showing bile duct paucity
PFIC (Progressive Familial Intrahepatic Cholestasis) E78.7 Genetic confirmation (ATP8B1/ABCB11/ABCB4), elevated serum bile acids >19 μmol/L
Cholestatic pruritus L29.8 (other pruritus) Link to underlying diagnosis; document intensity affecting quality of life

Supporting Documentation Language

Your clinical notes should include specific phrases that support medical necessity:

  • "Genetic testing confirms [specific mutation]"
  • "Elevated serum bile acids at [specific value] μmol/L"
  • "Failed trial of ursodiol with [specific outcome]"
  • "Contraindication to rifampin due to [specific reason]"
  • "Pruritus severity [scale/description] impacting sleep and daily activities"

Product Coding: HCPCS, NDC, and Dosing

HCPCS Coding

Primary Code: J8499 (Prescription drug, oral, non-chemotherapeutic, NOS)

Available Strengths and Quantity Limits

Strength NDC Number Monthly Limit Typical Pediatric Use
200 mcg oral pellets (verify with manufacturer) 900 capsules/30 days Ages 3-12 months
400 mcg capsules (verify with manufacturer) 450 capsules/30 days Weight-based dosing
600 mcg oral pellets (verify with manufacturer) 300 capsules/30 days Higher weight patients
1200 mcg capsules (verify with manufacturer) 150 capsules/30 days Adult/adolescent dosing

Weight-Based Dosing Calculations

  • PFIC patients ≥3 months: 40 mcg/kg once daily initially
  • Alagille syndrome ≥12 months: Per prescribing information
  • Dose escalation: May increase by 40 mcg/kg increments if no improvement after 3 months

Clean Prior Authorization Request

Required Elements for Approval

Patient Information:

  • Member ID and group number
  • Date of birth confirming age eligibility (≥3 months for PFIC, ≥12 months for Alagille)
  • Primary diagnosis with ICD-10 code

Clinical Documentation:

  • Genetic testing report confirming specific mutations
  • Laboratory results showing elevated bile acids or bilirubin
  • Documentation of failed trials with at least two alternatives:
    • Ursodeoxycholic acid (ursodiol) with specific duration and outcome
    • Rifampin with reason for discontinuation or contraindication
  • Hepatologist or gastroenterologist consultation notes

Prescription Details:

  • Exact strength and quantity requested
  • Weight-based dosing calculation showing medical necessity for quantity
  • Duration of therapy request (typically 12 months initial)
From our advocates: We've seen approvals come faster when the hepatologist's letter includes a specific statement like "Patient has documented PFIC2 with ABCB11 mutation confirmed by [lab name] on [date], with severe pruritus unresponsive to 6-month trial of ursodiol 20 mg/kg/day and contraindicated for rifampin due to drug interactions with [specific medication]." This level of detail addresses the most common denial reasons upfront.

Common Coding Pitfalls

Unit Conversion Errors

  • Mistake: Requesting adult doses for pediatric patients
  • Fix: Always calculate based on current weight in kg × 40 mcg/kg

Mismatched Benefit Categories

  • Mistake: Submitting under medical benefit with procedure codes
  • Fix: Use pharmacy benefit pathway with J8499 code

Missing Age Documentation

  • Mistake: Not clearly documenting patient meets minimum age requirements
  • Fix: Include birth date and current age prominently in PA request

Incomplete Step Therapy Documentation

  • Mistake: Vague statements about "failed other treatments"
  • Fix: Specific drug names, doses, duration, and reason for discontinuation

Verification with Blue Cross Blue Shield

Pre-Submission Checklist

  1. Confirm specialty pharmacy network via member services
  2. Verify current formulary status at anthem.com member portal
  3. Check quantity limits for patient's specific strength
  4. Confirm PA form version - use most recent from provider portal
  5. Validate ICD-10 codes against plan's medical policy

Provider Portal Resources

  • Availity Essentials for PA submissions
  • Anthem provider news for policy updates
  • Real-time eligibility verification tools

Appeals Process in Georgia

Internal Appeal (First Level)

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard review; 72 hours if expedited
  • Submission: Written appeal via Anthem provider portal or mail
  • Required: Medical necessity letter addressing specific denial reasons

External Review (Georgia Department of Insurance)

When to Request Expedited Review

Request expedited appeals when your physician documents that treatment delay would jeopardize health, particularly for:

  • Severe pruritus affecting sleep and development
  • Progressive liver dysfunction
  • Failed alternative therapies with worsening symptoms

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all strengths PA form via Availity
Age Limits ≥3 months (PFIC), ≥12 months (Alagille) Birth certificate/medical record
Specialty Pharmacy Mandatory dispensing channel Network verification
Genetic Testing Confirmed mutations required Laboratory report
Step Therapy Trial/failure of 2+ alternatives Prescription history, clinical notes
Prescriber Hepatologist/gastroenterologist preferred Consultation notes
Quantity Limits Varies by strength (see table above) Weight-based calculation

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Bylvay. Our platform analyzes denial letters and plan policies to identify the specific basis for denial—whether it's PA criteria, step therapy requirements, or "not medically necessary" determinations—then drafts point-by-point rebuttals aligned to the plan's own rules. For rare disease medications requiring extensive documentation, we help clinicians gather the right evidence and present it in the format payers expect. Learn more about our appeals platform.

FAQ

How long does Blue Cross Blue Shield prior authorization take in Georgia? Standard PA decisions are made within 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

What if Bylvay is not on my formulary? You can request a formulary exception with medical necessity documentation. This requires demonstrating that covered alternatives are ineffective or contraindicated.

Can I appeal if my child doesn't meet the exact age requirements? Yes, you can appeal with compelling medical evidence. Document why treatment is urgent despite age, such as severe symptoms or rapid disease progression.

Does step therapy apply if we've failed treatments outside Georgia? Yes, documented treatment failures from other states count toward step therapy requirements. Ensure you have complete medical records from previous providers.

What happens if the external review denies my appeal? External review decisions are final for the administrative process. Further disputes would require legal action, though this is rare for properly documented cases.

Are there patient assistance programs while appeals are pending? Yes, Ipsen (the manufacturer) offers patient assistance programs. Contact them directly for temporary supply options during the appeals process.

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 benefits and medical circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage questions. For assistance with complex appeals, consider consulting with Counterforce Health or other specialized advocacy services.

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