By Counterforce Health Team in Crysvita (burosumab) —

How to Get Crysvita (burosumab) Covered by Blue Cross Blue Shield in Ohio: Prior Authorization, Appeals & Step Therapy Guide

Answer Box: Getting Crysvita Covered in Ohio

Blue Cross Blue Shield Ohio requires prior authorization for Crysvita (burosumab), with step therapy requiring failure of oral phosphate and vitamin D first. Coverage is restricted to FDA-approved uses (X-linked hypophosphatemia and tumor-induced osteomalacia) with specialist prescription. If denied, you have 180 days to appeal internally, then can request external review through Ohio Department of Insurance within 4 months. First step today: Contact your endocrinologist to document prior treatment failures and submit the prior authorization request through your plan's specialty pharmacy network.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization & Step Therapy Requirements
  4. Specialty Pharmacy Network Requirements
  5. Cost-Share Dynamics
  6. Submission Process & Forms
  7. Common Approval Patterns
  8. Appeals Playbook for Ohio
  9. Frequently Asked Questions

Plan Types & Coverage Implications

Blue Cross Blue Shield operates multiple plan types in Ohio, each with different coverage rules for Crysvita:

Commercial Plans (Employer-Sponsored)

  • Most common BCBS Ohio coverage type
  • Prior authorization required for all specialty biologics
  • Appeals follow Ohio state regulations for fully-insured plans
  • Self-funded employer plans may have different appeal rights under ERISA

Individual/ACA Marketplace Plans

  • Subject to essential health benefits requirements
  • Must cover FDA-approved treatments when medically necessary
  • External review available through Ohio Department of Insurance

Medicaid Managed Care

  • Stricter step therapy requirements often apply
  • May require additional documentation of medical necessity
  • Appeals process includes state fair hearing option
Note: Anthem Blue Cross Blue Shield is the largest BCBS carrier in Ohio with approximately 31% market share. Policy details may vary between different Blue plans operating in the state.

Formulary Status & Tier Placement

Medical Benefit Coverage Crysvita is typically covered under the medical benefit rather than pharmacy formulary tiers. This means:

  • Billed using HCPCS code J0584
  • Subject to medical deductible and coinsurance
  • Administered in clinical settings (physician office, outpatient infusion center)

Coverage Restrictions

  • Prior authorization required for all requests
  • Specialty pharmacy dispensing mandatory for take-home doses
  • Site of care restrictions may apply (non-hospital outpatient preferred)

Prior Authorization & Step Therapy Requirements

Coverage Criteria Table

Requirement Details Documentation Needed
Diagnosis X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO) Lab results, genetic testing, imaging
Prescriber Endocrinologist or metabolic bone disease specialist Specialist consultation notes
Step Therapy Failure/intolerance to oral phosphate + vitamin D analogs Treatment history, side effects
Contraindications Cannot use with concurrent oral phosphate/vitamin D Medication reconciliation
Dosing Per FDA label: Pediatric ≤90mg q2 weeks; Adult ≤90mg q4 weeks Dosing rationale

Step Therapy Requirements

You must first try and document failure of:

  1. Oral phosphate supplements (sodium phosphate, potassium phosphate)
  2. Active vitamin D analogs (calcitriol, doxercalciferol, paricalcitol)

Acceptable reasons for step therapy bypass:

  • Medical contraindications to conventional therapy
  • Previous intolerance with documented adverse effects
  • Clinical evidence that conventional therapy is inappropriate
Critical Warning: Crysvita is contraindicated in patients currently taking oral phosphate and active vitamin D. These medications must be discontinued before starting burosumab therapy.

Specialty Pharmacy Network Requirements

Anthem BCBS Ohio Approved Specialty Pharmacies:

  • BioPlus Specialty Pharmacy
  • CareMed Specialty Pharmacy
  • CenterWell Pharmacy
  • CVS Specialty
  • Harness Health Pharmacy
  • Noble Health Services Specialty Pharmacy
  • St. Matthews Specialty Pharmacy
  • Transcript Pharmacy
  • TwelveStone Health Partners

Important Network Rules:

  • Out-of-network specialty pharmacies will result in no coverage
  • Patient may be responsible for full drug cost ($4,000-$40,000+ per vial)
  • Verify current network status before prescribing

Cost-Share Dynamics

Typical Cost Structure:

  • Medical deductible applies first
  • Coinsurance typically 10-30% after deductible
  • Out-of-pocket maximum provides annual protection

Cost-Saving Options:

This information is educational only and not financial advice. Consult your insurance documents for specific cost-sharing details.

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (1-2 days)
    • Lab results showing hypophosphatemia and renal phosphate wasting
    • Genetic testing confirming PHEX mutation (if available)
    • Prior treatment records and failure documentation
  2. Specialist Consultation (1-2 weeks)
    • Endocrinologist or metabolic bone specialist evaluation
    • Medical necessity letter with clinical rationale
    • Dosing plan per FDA guidelines
  3. Prior Authorization Submission (Same day)
    • Submit through BCBS provider portal or designated specialty pharmacy
    • Include all required documentation
    • Request expedited review if clinically urgent
  4. Initial Review (5-15 business days)
    • BCBS clinical team reviews submission
    • May request additional information
    • Peer-to-peer review available if needed
  5. Determination (Within 30 days standard)
    • Approval: Prescription can be dispensed
    • Denial: Written explanation provided with appeal rights

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements:

  • Patient diagnosis with ICD-10 codes (E83.31 for XLH)
  • Biochemical evidence: serum phosphate levels, alkaline phosphatase, FGF23
  • Prior treatment history: specific medications tried, duration, outcomes
  • Contraindications or intolerance to conventional therapy
  • Clinical rationale referencing FDA prescribing information
  • Proposed dosing schedule and monitoring plan
  • Expected clinical outcomes and treatment goals

Common Approval Patterns

Strong Submissions Include:

  • Comprehensive biochemical workup confirming diagnosis
  • Clear documentation of step therapy compliance or valid bypass reasons
  • Specialist consultation notes supporting medical necessity
  • Detailed treatment history with objective outcome measures
  • Appropriate dosing per FDA labeling

Common Denial Reasons & Solutions:

Denial Reason Solution
Insufficient diagnostic evidence Submit complete lab panel, genetic testing, imaging studies
Step therapy not completed Document oral phosphate/vitamin D trials and failures
Concurrent contraindicated medications Confirm discontinuation of oral phosphate/vitamin D
Dosing exceeds guidelines Revise prescription to FDA-approved dosing ranges
Non-specialist prescriber Obtain endocrinologist consultation and co-signature

Appeals Playbook for Ohio

Internal Appeals Process

Level 1: Standard Internal Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for decision (72 hours if expedited)
  • Submission: Written appeal with supporting documentation
  • Contact: Use member services number on insurance card

Level 2: Peer-to-Peer Review

  • Available upon request during internal appeal
  • Prescribing physician speaks directly with BCBS medical director
  • Often resolves complex cases without formal appeal process

External Review Through Ohio Department of Insurance

Eligibility: After completing internal appeals and receiving final adverse determination

Timeline:

  • Request deadline: 4 months after final internal denial
  • Standard review: 30 days for IRO decision
  • Expedited review: 72 hours for urgent cases

How to Request:

  1. Contact Ohio Department of Insurance at 800-686-1526
  2. Submit External Review Request Form
  3. Include all medical records and denial letters
  4. Independent Review Organization (IRO) assigned to case

Binding Decision: IRO determination is final and binding on BCBS

From our advocates: "We've seen several Ohio patients succeed with external review for Crysvita after initial denials. The key was submitting comprehensive genetic testing results and detailed documentation of conventional therapy failures. While outcomes aren't guaranteed, thorough preparation significantly improves success rates."

Frequently Asked Questions

How long does BCBS prior authorization take in Ohio? Standard reviews take up to 30 days, but many Crysvita requests are processed within 10-15 business days when complete documentation is provided.

What if Crysvita isn't on my plan's formulary? Crysvita is typically covered under medical benefits rather than pharmacy formulary. Contact member services to confirm coverage pathway for your specific plan.

Can I request expedited approval? Yes, if your physician certifies that delays would seriously jeopardize your health or ability to function. Expedited reviews must be completed within 72 hours.

Does step therapy apply if I failed treatments in another state? Yes, documented treatment failures from other states are generally accepted if properly documented in medical records.

What happens if my appeal is denied? You can request external review through the Ohio Department of Insurance, which provides an independent medical expert review that's binding on your insurer.

Are there financial assistance programs? Yes, Kyowa Kirin offers patient support including copay assistance up to $15,000 annually for eligible patients.

Where to Verify Current Information

Official Resources:

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Crysvita. Our platform analyzes denial letters, identifies the specific coverage criteria, and generates evidence-backed appeals that align with each payer's requirements, helping patients and clinicians navigate the prior authorization process more effectively.

When dealing with specialty drug denials, having the right documentation and understanding payer-specific requirements can make the difference between approval and denial. Counterforce Health helps ensure your appeal addresses the exact coverage criteria that matter to your specific Blue Cross Blue Shield plan.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with your specific insurance plan and consult healthcare professionals for medical decisions. For personalized assistance with appeals and prior authorizations, contact the Ohio Department of Insurance at 800-686-1526.

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