By Counterforce Health Team in Vyondys 53 (golodirsen) —

Coding That Gets Vyondys 53 (Golodirsen) Approved by Humana in Georgia: ICD-10, J-Code & NDC Guide

Answer Box: Fast Track to Vyondys 53 Coverage

Getting Vyondys 53 (golodirsen) approved by Humana in Georgia requires precise medical coding and documentation. Use ICD-10 code G71.01 for Duchenne muscular dystrophy, HCPCS J1429 for billing (10mg units), and NDC 60923-0465-01. Submit genetic testing confirming exon 53-skippable mutation with your prior authorization. If denied, you have 65 days for internal appeals and 60 days for Georgia's external review. Start today: Verify your genetic test shows an exon 53-amenable mutation and gather baseline kidney function labs (required for monitoring).

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Vyondys 53 (golodirsen) is billed under the medical benefit, not pharmacy benefit, because it's a provider-administered infusion therapy. This means your doctor's office or infusion center uses the "buy-and-bill" process—they purchase the drug, administer it, then bill Humana for both the medication and the infusion service.

Key differences:

  • Medical benefit: Uses HCPCS J-codes, requires prior authorization through medical management
  • Pharmacy benefit: Uses NDC numbers, processed through pharmacy benefit managers (PBMs)

For Vyondys 53, you'll always go through Humana's medical prior authorization process, not their pharmacy department.

ICD-10 Mapping for DMD

The correct diagnosis code for all Duchenne muscular dystrophy cases, including those with exon 53 mutations, is G71.01. This specific code replaced the older, broader muscular dystrophy codes and is essential for insurance approval.

Documentation requirements that support G71.01 coding:

  • Genetic testing report confirming dystrophin gene mutation
  • Muscle biopsy results (if available)
  • Clinical notes describing progressive muscle weakness
  • Family history documentation
  • Functional assessments showing muscle deterioration
Tip: When documenting for insurance, explicitly state "Duchenne muscular dystrophy with mutation amenable to exon 53 skipping" in clinical notes. This language directly supports both the ICD-10 code and the drug's FDA indication.

Common comorbid conditions to code alongside G71.01:

  • I42.8 - Other cardiomyopathies (if cardiac involvement present)
  • J44.1 - Chronic obstructive pulmonary disease with acute exacerbation (respiratory complications)
  • Z87.891 - Personal history of nicotine dependence (if relevant)

Product Coding: HCPCS, J-Code & NDC

HCPCS J-Code: J1429

  • Description: Injection, golodirsen, 10 mg
  • Billing units: Each unit = 10 mg of golodirsen
  • Dosing calculation: For a 70 kg patient receiving 30 mg/kg weekly = 2,100 mg = 210 units of J1429

NDC Number: 60923-0465-01

  • Vial size: 100 mg/2 mL single-dose vial
  • Manufacturer: Sarepta Therapeutics
  • Storage: Refrigerated; must be diluted before administration

Administration Coding

Use CPT 96413 for the initial hour of IV infusion. For infusions longer than one hour, add CPT 96415 for each additional 30 minutes.

Units calculation example:

  • Patient weight: 50 kg
  • Weekly dose: 30 mg/kg = 1,500 mg
  • J1429 units needed: 1,500 mg ÷ 10 mg per unit = 150 units
  • Vials required: 1,500 mg ÷ 100 mg per vial = 15 vials

Clean Request Anatomy

A complete prior authorization request for Vyondys 53 should include:

Patient Information Section:

  • Humana member ID and group number
  • Patient name, DOB, address
  • Primary care physician and referring specialist

Clinical Documentation:

  • ICD-10 code G71.01 with supporting diagnosis narrative
  • Genetic testing report showing exon 53-amenable mutation
  • Baseline kidney function tests (serum cystatin C, urine protein-to-creatinine ratio)
  • Current functional status assessment

Treatment Plan:

  • HCPCS J1429 with calculated weekly units
  • NDC 60923-0465-01 for drug identification
  • Infusion site (office, hospital outpatient, home)
  • Monitoring schedule per FDA requirements

Medical Necessity Statement:

  • Previous treatments tried and failed
  • Clinical rationale for exon-skipping therapy
  • Expected outcomes and monitoring plan
From our advocates: One Georgia family found success by having their neurologist include a detailed timeline showing how other DMD therapies had been tried over 18 months before requesting Vyondys 53. The chronological approach helped Humana understand why standard treatments weren't sufficient, leading to approval within two weeks.

Frequent Coding Pitfalls

Unit Conversion Errors The most common mistake is incorrectly calculating J1429 units. Remember: each unit equals 10 mg, not 1 mg. A 30 mg/kg dose for a 60 kg patient requires 180 units (1,800 mg ÷ 10), not 1,800 units.

Mismatched NDC Numbers Always verify the NDC matches your actual vial size. Using the wrong NDC can trigger automatic denials or payment delays.

Missing Start Dates Humana requires specific treatment start dates in prior authorization requests. "As soon as possible" or "pending approval" won't suffice—provide a target date within 30 days.

Incomplete Genetic Documentation Simply stating "genetic testing positive" isn't enough. The report must specifically identify mutations that make exon 53 skipping therapeutically appropriate.

Wrong Benefit Category Never submit Vyondys 53 claims through pharmacy benefits. This automatic routing error causes immediate denials that can delay treatment by weeks.

Verification with Humana Resources

Before submitting any request, verify current requirements using Humana's official tools:

Prior Authorization Search Tool Visit Humana's provider portal and search for "golodirsen" or "J1429" to confirm current PA requirements and submission methods.

Coverage Determination Database Check if Humana has issued any recent coverage determinations for Vyondys 53 that might affect your case.

Formulary Status Verify the drug's current formulary tier and any quantity limits that might apply to your patient's specific plan.

Note: Counterforce Health specializes in navigating these complex prior authorization requirements, automatically checking current payer policies and generating targeted appeals when initial requests are denied.

Pre-Submission Audit Checklist

Before submitting your Vyondys 53 prior authorization to Humana:

✓ Patient eligibility verified (active Humana coverage, benefits confirmed) ✓ ICD-10 G71.01 documented in medical record and PA request ✓ Genetic testing report attached showing exon 53-amenable mutation ✓ J1429 units calculated correctly based on patient weight and 30 mg/kg dosing ✓ NDC 60923-0465-01 specified for 100 mg/2 mL vials ✓ Baseline monitoring labs completed (cystatin C, urine protein) ✓ Medical necessity letter from neuromuscular specialist ✓ Previous treatment history documented with outcomes ✓ Infusion site and administration plan specified ✓ Contact information for prescriber peer-to-peer review

Appeals Process in Georgia

If Humana denies your initial request, Georgia provides multiple appeal levels:

Internal Appeals (First Level)

  • Timeline: 65 days from denial notice
  • Process: Submit through Humana member portal or by mail
  • Documentation: Include all original materials plus any new supporting evidence
  • Decision timeframe: 30 days for standard, 72 hours for expedited

External Review (Georgia Department of Insurance)

  • Eligibility: After completing internal appeal or for urgent cases
  • Timeline: 60 days from final internal denial
  • Cost: Free to patients
  • Process: Submit application to Georgia DOI Consumer Services
  • Decision: Binding on Humana, typically within 45 days

Georgia DOI Contact Information:

When Counterforce Health handles appeals, they automatically track these deadlines and ensure all required documentation is included, significantly improving approval rates for complex specialty drugs like Vyondys 53.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Humana PA Lists
ICD-10 Code G71.01 (Duchenne muscular dystrophy) Medical record documentation
HCPCS Code J1429 (10 mg units) Billing system
NDC Number 60923-0465-01 Drug vial label
Genetic Testing Exon 53-amenable mutation confirmed Lab report
Monitoring Labs Monthly urine, quarterly cystatin C FDA Label Requirements

FAQ

How long does Humana prior authorization take for Vyondys 53 in Georgia? Standard decisions take up to 30 days. Expedited reviews (for urgent cases) must be completed within 72 hours. Starting January 2026, Humana will be required to respond within 7 days for all medical items.

What if Vyondys 53 is not on Humana's formulary? As a medical benefit drug, formulary status is less relevant than for pharmacy benefits. However, you can request a formulary exception with medical necessity documentation.

Can I request an expedited appeal if my child's condition is worsening? Yes. If delay would seriously jeopardize health or ability to regain function, both internal and external expedited reviews are available in Georgia.

Does step therapy apply to Vyondys 53 in Georgia? Step therapy requirements vary by plan. Some require trying corticosteroids first, while others recognize that exon-skipping therapy addresses a different mechanism and may not require prior failures.

What happens if I miss the appeal deadline? Georgia allows 60 days for external review requests. Missing this deadline typically forecloses your appeal rights, though extreme circumstances might allow exceptions.

How much does Vyondys 53 cost if insurance doesn't cover it? Without insurance, Vyondys 53 can cost approximately $300,000-400,000 annually. Sarepta offers patient assistance programs for eligible families.

Can I switch infusion sites after approval? Yes, but notify Humana of the change. Different sites may require updated prior authorizations or have different billing arrangements.

What documentation should I keep during treatment? Maintain copies of all approval letters, lab results, infusion records, and any correspondence with Humana. These may be needed for renewal authorizations or appeals.

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures can change. Always verify current requirements with your insurance provider and consult healthcare professionals for medical decisions.

Sources & Further Reading

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