By Counterforce Health Team in Vyondys 53 (golodirsen) —

Getting Vyondys 53 (Golodirsen) Covered by Blue Cross Blue Shield in Ohio: ICD-10, HCPCS J-Code, and Prior Authorization Guide

Answer Box: Getting Vyondys 53 Covered in Ohio

Vyondys 53 (golodirsen) requires prior authorization from Blue Cross Blue Shield Ohio through their NovoLogix portal. You'll need genetic confirmation of DMD with exon 53-skippable mutation (ICD-10: G71.01), proper billing codes (HCPCS J1429, NDC 60923-0465), and clinical documentation. Submit via your neurologist within 15 business days for standard review. If denied, file internal appeal within 180 days, then escalate to Ohio Department of Insurance external review (1-800-686-1526).

First step today: Contact your neurologist to initiate prior authorization with genetic test results and infusion monitoring plan.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Duchenne Muscular Dystrophy
  3. Product Coding: HCPCS, J-Code, and NDC
  4. Clean Request Anatomy
  5. Frequent Pitfalls
  6. Verification with Blue Cross Blue Shield Ohio
  7. Quick Audit Checklist
  8. Appeals Playbook for Ohio
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Vyondys 53 typically falls under the medical benefit since it's administered via IV infusion in clinical settings. This affects both coding requirements and prior authorization pathways with Blue Cross Blue Shield Ohio.

Medical Benefit Coverage

  • Administration codes: CPT 96413 (initial hour) and 96415 (additional hours)
  • Drug code: HCPCS J1429 (injection, golodirsen, 10 mg)
  • Prior authorization: Required through NovoLogix portal
  • Site of care: Hospital outpatient or infusion center for monitoring

Key Documentation Requirements

Blue Cross Blue Shield Ohio requires specific clinical documentation that supports both the diagnosis coding and medical necessity:

  • Confirmed DMD gene mutation amenable to exon 53 skipping
  • Ambulatory status assessment (6-Minute Walk Test ≥300 meters preferred)
  • Baseline renal function tests (serum cystatin C, urine protein-to-creatinine ratio)
  • Infusion monitoring plan with 0.2 micron filter specifications

ICD-10 Mapping for Duchenne Muscular Dystrophy

Primary Diagnosis Code

G71.01 - Duchenne or Becker muscular dystrophy is the specific ICD-10 code that became effective in 2016. This code is critical for Vyondys 53 coverage as it distinguishes DMD from other muscular dystrophies.

Supporting Documentation Language

When documenting in medical records, include specific phrases that support the ICD-10 coding and prior authorization:

  • "Confirmed DMD gene mutation with deletion amenable to exon 53 skipping"
  • "Dystrophin-deficient muscular dystrophy with genetic confirmation"
  • "Ambulatory Duchenne muscular dystrophy patient"
  • "Progressive muscle weakness consistent with DMD phenotype"

Additional Codes to Consider

  • Z87.891 - Personal history of nicotine dependence (if applicable for contraindication documentation)
  • Z51.11 - Encounter for antineoplastic chemotherapy (for infusion administration)
  • N18.6 - End stage renal disease (contraindication if present)

Product Coding: HCPCS, J-Code, and NDC

HCPCS J-Code Details

J1429 - Injection, golodirsen, 10 mg

  • Effective July 1, 2020
  • Billing unit: 1 unit = 10 mg
  • Dosing: 30 mg/kg weekly (maximum 1,200 mg/week)

NDC Number

60923-0465-xx - Vyondys 53, 100 mg/2 mL single-dose vial

Unit Calculation Example

For a 40 kg patient:

  • Dose = 40 kg × 30 mg/kg = 1,200 mg
  • Billing units = 1,200 mg ÷ 10 mg = 120 units of J1429
  • Vials needed = 1,200 mg ÷ 100 mg = 12 vials

Administration Coding

  • 96413 - IV infusion, up to 1 hour (primary code)
  • 96415 - Each additional hour (if infusion exceeds 60 minutes)

Clean Request Anatomy

Example Prior Authorization Request Structure

Patient Information:

  • Name, DOB, Blue Cross Blue Shield Ohio member ID
  • ICD-10: G71.01 (Duchenne muscular dystrophy)
  • Prescribing neurologist with DMD specialization

Clinical Documentation:

  • Genetic test results showing exon 53-skippable mutation
  • Baseline ambulatory assessment scores
  • Prior corticosteroid therapy history
  • Contraindication documentation (if applicable)

Product Details:

  • Drug: Vyondys 53 (golodirsen)
  • HCPCS: J1429
  • NDC: 60923-0465
  • Dose: 30 mg/kg IV weekly
  • Duration: Initial 6-12 months with renewal based on stability

Monitoring Plan:

  • Pre-infusion renal function assessment
  • Monthly urine protein monitoring
  • Quarterly serum cystatin C and GFR
  • Infusion center with 0.2 micron filter capability

Frequent Pitfalls

Common Coding Errors

Error Correction Impact
Using J3490 (unclassified drug) Use J1429 specifically Automatic denial
Wrong unit calculation 1 unit = 10 mg, not per vial Billing rejection
Missing modifier -JW Add for discarded drug amounts Payment issues
Incorrect administration CPT Use 96413/96415, not 96365 Claim denial

Documentation Gaps

  • Missing genetic confirmation: Include FDA-approved test results
  • Inadequate monitoring plan: Specify renal function protocols
  • Vague medical necessity: Document failed therapies and contraindications
  • Wrong site of care: Ensure infusion center capabilities for monitoring

Verification with Blue Cross Blue Shield Ohio

Pre-Submission Verification Steps

  1. Check plan participation: Verify specialty drug coverage via Availity provider portal
  2. Confirm formulary status: Search drug lists at Anthem Ohio pharmacy information
  3. Validate prior authorization requirements: Review current PA criteria through NovoLogix
  4. Verify billing codes: Cross-reference J1429 with plan's HCPCS coverage

Key Resources

  • Provider services: 1-800-362-0002 (Ohio pharmacy services)
  • PA submission: NovoLogix portal (electronic preferred)
  • Appeals fax: 1-888-482-4332
  • Member services: Number on insurance ID card

At Counterforce Health, we help patients and providers navigate these complex verification steps by automating the cross-referencing of plan policies with clinical documentation requirements.

Quick Audit Checklist

Pre-Submission Review

Clinical Documentation:

  • ICD-10 G71.01 confirmed in medical record
  • Genetic test showing exon 53-skippable DMD mutation
  • Baseline renal function tests completed
  • Ambulatory status documented
  • Prior therapy history (corticosteroids) included

Coding Accuracy:

  • HCPCS J1429 units calculated correctly (dose ÷ 10 mg)
  • NDC 60923-0465 matches Vyondys 53 vials
  • Administration CPT codes 96413/96415 included
  • Modifier -JW added for any drug waste

Administrative Requirements:

  • Prior authorization submitted via NovoLogix
  • Prescriber is board-certified neurologist
  • Infusion site has monitoring capabilities
  • Insurance eligibility verified

Supporting Evidence:

  • FDA labeling referenced for dosing
  • Monitoring plan follows prescribing information
  • Medical necessity letter addresses plan criteria
  • All required attachments included

Appeals Playbook for Ohio

Internal Appeal Process

First Level Appeal:

  • Deadline: 180 days from denial
  • Submission: Provider portal, fax 1-888-482-4332, or mail
  • Timeline: 15 days standard, 72 hours urgent
  • Required: New clinical evidence, peer-reviewed studies, guideline references

Second Level Appeal:

  • Deadline: 60 days from first-level denial
  • Review: Independent medical professionals
  • Timeline: 30 days standard, 72 hours urgent

External Review (Ohio Department of Insurance)

Eligibility: After exhausting internal appeals for fully insured plans

  • Contact: 1-800-686-1526
  • Deadline: 180 days from final internal denial
  • Process: Independent Review Organization (IRO) assignment
  • Timeline: 30 days standard, 72 hours expedited
  • Binding: Decision is final and binding on insurer
From our advocates: We've seen success when families include published case studies showing dystrophin improvement with exon 53 skipping therapy in their appeal letters. While individual results vary, peer-reviewed evidence strengthens the medical necessity argument significantly.

Escalation Resources

  • Ohio Department of Insurance: insurance.ohio.gov
  • UHCAN Ohio: Consumer advocacy for health coverage appeals
  • Legal aid: For complex ERISA plan appeals

FAQ

How long does Blue Cross Blue Shield Ohio prior authorization take? Standard review is 15 business days; urgent requests are processed within 72 hours. Submit through NovoLogix portal for fastest processing.

What if Vyondys 53 is non-formulary on my plan? Submit a formulary exception request with your prior authorization, documenting medical necessity and failure of preferred alternatives.

Can I request an expedited appeal if my child's condition is worsening? Yes, if delay would seriously jeopardize health. Contact member services immediately and provide clinical documentation of urgency.

Does step therapy apply if we've tried other DMD treatments? Document all prior therapies (corticosteroids, other exon-skipping drugs) with dates, dosing, and reasons for discontinuation.

What monitoring is required during treatment? Monthly urine protein checks, quarterly blood tests for kidney function, and pre-infusion assessments per FDA labeling requirements.

How do I find a qualified infusion center in Ohio? Contact Blue Cross Blue Shield Ohio provider services or check your plan's specialty pharmacy network for approved facilities.

What if my employer plan is self-funded? Self-funded ERISA plans follow federal appeals rules, not Ohio state external review. Check your Summary Plan Description for specific procedures.

Are there financial assistance programs available? Sarepta Therapeutics offers patient support programs. Check eligibility at Vyondys53.com or call their patient services line.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and circumstances. Always verify current policies with your insurance provider and consult healthcare professionals for medical guidance. For personalized assistance with prior authorizations and appeals, Counterforce Health provides evidence-based support to help patients navigate complex insurance requirements.

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