By Counterforce Health Team in Translarna (ataluren) —

How to Get Translarna (Ataluren) Covered by Aetna CVS Health in Georgia: Complete Coding, Prior Authorization, and Appeals Guide

Answer Box: Getting Translarna (Ataluren) Covered by Aetna CVS Health in Georgia

Translarna (ataluren) requires prior authorization from Aetna CVS Health with strict medical necessity criteria: confirmed nonsense mutation DMD, ambulatory status, age 2+, and specialist prescription. If denied, you have 180 days for internal appeal and 60 days for Georgia Department of Insurance external review. First step today: Contact your neurologist to begin genetic testing confirmation and prior authorization submission via Availity portal or CVS Caremark Specialty Pharmacy.

Table of Contents

  1. Coding Basics: Medical vs Pharmacy Benefit
  2. ICD-10 Mapping for Duchenne Muscular Dystrophy
  3. Product Coding: HCPCS, NDC, and Dosing Units
  4. Clean Prior Authorization Request
  5. Common Coding and Billing Pitfalls
  6. Verification with Aetna CVS Health Resources
  7. Georgia Appeals Process
  8. Pre-Submission Audit Checklist

Coding Basics: Medical vs Pharmacy Benefit

Translarna (ataluren) billing depends on your Aetna CVS Health plan structure and dispensing location. Most outpatient use falls under the pharmacy benefit, while clinic-administered doses may process through medical benefit.

Pharmacy Benefit Path

  • Standard route for take-home oral suspension
  • Uses NDC codes and standard prescription drug claim processing
  • Dispensed through CVS Caremark Specialty Pharmacy as required by most Aetna policies
  • Prior authorization mandatory through pharmacy benefit management

Medical Benefit Path

  • Used when administered or managed in clinical settings
  • Requires HCPCS codes (typically J3490 or J9999 for unclassified drugs)
  • May apply JW modifier for drug wastage from single-use sachets
  • Less common for Translarna's oral formulation
Tip: Contact your Aetna CVS Health member services (number on your ID card) to confirm which benefit applies to your specific plan before submitting claims.

ICD-10 Mapping for Duchenne Muscular Dystrophy

The primary diagnosis code for all forms of Duchenne muscular dystrophy, including nonsense mutation cases, is G71.01 ("Duchenne or Becker muscular dystrophy"). This code should be used regardless of the specific genetic mutation type.

Required Documentation for G71.01

  • Genetic testing results confirming dystrophin gene mutation
  • Clinical notes specifying DMD diagnosis and mutation type (nonsense mutation for Translarna eligibility)
  • Functional status assessment documenting ambulatory vs non-ambulatory status
  • Specialist confirmation from neurologist, geneticist, or pediatric neuromuscular specialist

Supporting Secondary Codes

Add these codes when applicable to provide complete clinical picture:

Complication ICD-10 Code When to Use
Cardiomyopathy I42.8 Heart involvement documented
Joint contractures M24.5- Specific joint affected
Muscle contractures M62.4- Muscle-specific contractures
Scoliosis M41.- Spinal curvature present
Note: Document ambulatory status clearly in clinical notes—this directly impacts Translarna eligibility and insurance approval decisions.

Product Coding: HCPCS, NDC, and Dosing Units

Translarna does not have a permanent HCPCS J-code as of 2024. Providers should use J3490 ("Unclassified drugs") or J9999 ("Not otherwise classified") for medical benefit billing, with clear documentation specifying Translarna (ataluren) for nonsense mutation DMD.

Dosing and Unit Conversion

Standard dosing: 40 mg/kg/day divided as:

  • Morning: 10 mg/kg
  • Midday: 10 mg/kg
  • Evening: 20 mg/kg

Example calculation for 25 kg patient:

  • Morning: 250 mg
  • Midday: 250 mg
  • Evening: 500 mg
  • Total daily: 1,000 mg

Available Sachet Strengths and NDC

Translarna comes in 125 mg, 250 mg, and 1000 mg sachets. NDC numbers vary by package size and should be verified with CVS Caremark Specialty Pharmacy at dispensing.

Billing Modifiers

  • JW modifier: Use for documented drug wastage from single-use sachets
  • No specific modifiers are formally established for Translarna billing
  • Always verify current modifier requirements with your specific Aetna CVS Health plan

Clean Prior Authorization Request

A complete prior authorization request includes all required clinical documentation and follows Aetna CVS Health's specific submission process.

Required Documentation Checklist

  • Genetic testing report confirming nonsense mutation in dystrophin gene
  • Medical necessity letter from prescribing specialist
  • Ambulatory status documentation (recent clinic visit notes, timed walk test)
  • Prior therapy history (corticosteroids, physical therapy outcomes)
  • Patient demographics (age verification ≥2 years)
  • Treatment plan with monitoring schedule

Medical Necessity Letter Components

Your specialist should include:

  1. Confirmed nonsense mutation with genetic test reference
  2. Current ambulatory status with functional assessment
  3. Prior therapy failures or contraindications to standard care
  4. Expected clinical benefit from Translarna therapy
  5. Safety monitoring plan and follow-up schedule

Submission Process

Submit through the Availity portal or directly to CVS Caremark Specialty Pharmacy. Processing typically takes 2-3 weeks, with follow-up recommended after 5-7 business days.

Common Coding and Billing Pitfalls

Unit Conversion Errors

  • Mistake: Using total daily dose instead of individual administration doses
  • Fix: Calculate each administration separately (10-10-20 mg/kg pattern)
  • Verification: Cross-check calculations with pharmacy before dispensing

Mismatched Benefit Categories

  • Mistake: Submitting to medical benefit when pharmacy benefit applies
  • Fix: Verify benefit category with Aetna member services before submission
  • Documentation: Keep records of benefit verification calls

Missing Genetic Documentation

  • Mistake: Submitting PA without confirmed nonsense mutation testing
  • Fix: Ensure genetic testing specifically identifies nonsense mutation type
  • Timeline: Allow 2-4 weeks for genetic testing results before PA submission

Incomplete Ambulatory Status Documentation

  • Mistake: Vague functional status descriptions
  • Fix: Include specific assessments (6-minute walk test, current mobility aids)
  • Updates: Document any changes in ambulatory status at each visit

Verification with Aetna CVS Health Resources

Before submitting any prior authorization or claim, verify current requirements through official Aetna CVS Health channels.

Key Verification Steps

  1. Formulary status: Check current formulary placement through member portal
  2. Prior authorization criteria: Review latest medical policy requirements
  3. Preferred pharmacy: Confirm CVS Caremark Specialty Pharmacy enrollment
  4. Benefit verification: Confirm medical vs pharmacy benefit application

Official Resources

  • Aetna Provider Portal: Current PA forms and medical policies
  • CVS Caremark: Specialty pharmacy enrollment and NDC verification
  • Member Services: Plan-specific benefit verification (phone number on ID card)
Important: Policies can change quarterly. Always verify current requirements before each new PA submission.

Georgia Appeals Process

Georgia residents have specific rights and deadlines for appealing Aetna CVS Health denials through state-mandated external review.

Internal Appeal (Required First Step)

  • Deadline: 180 days from initial denial date
  • Submission: Through Aetna member portal, phone, or written request
  • Timeline: Standard decision within 30-45 days; expedited within 72 hours if urgent
  • Required: Must complete internal appeal before external review (except in urgent situations)

Georgia External Review Process

If internal appeal is denied, Georgia law provides binding external review through the Department of Insurance.

Step Deadline Contact Process
Request external review 60 days from final internal denial Georgia DOI Consumer Services: 1-800-656-2298 Submit application with medical records
DOI assigns reviewer Within 5 days Georgia DOI Independent medical expert review
Final decision 30 business days (72 hours if expedited) Georgia DOI Binding decision issued

Required Documentation for External Review

  • Copy of final internal appeal denial letter
  • All medical records supporting medical necessity
  • Completed Georgia external review application
  • Any additional clinical evidence not previously submitted
Note: External review is free for consumers and the decision is binding on Aetna CVS Health.

Pre-Submission Audit Checklist

Use this checklist before submitting any Translarna prior authorization or appeal:

Clinical Documentation

  • Genetic testing confirms nonsense mutation DMD
  • Patient meets age requirement (≥2 years)
  • Current ambulatory status documented with recent assessment
  • Specialist prescriber credentials verified
  • Medical necessity letter includes all required elements

Coding Verification

  • Primary diagnosis: G71.01 (Duchenne or Becker muscular dystrophy)
  • Supporting codes added for complications as applicable
  • NDC verified with CVS Caremark Specialty Pharmacy
  • Appropriate HCPCS code selected if medical benefit applies
  • Dosing calculations verified (40 mg/kg/day total)

Submission Requirements

  • Correct benefit category confirmed (medical vs pharmacy)
  • All required forms completed
  • Supporting documentation attached
  • Submission method verified (Availity portal vs specialty pharmacy)
  • Follow-up timeline established

Appeal Preparation

  • Internal appeal deadline calculated (180 days from denial)
  • Georgia external review deadline noted (60 days from final internal denial)
  • Contact information for Georgia DOI Consumer Services saved
  • Additional clinical evidence identified for potential appeal

From our advocates: We've seen many Translarna approvals succeed when families work closely with their neuromuscular specialist to document the specific nonsense mutation and current ambulatory function. The key is often in the genetic testing details—make sure the lab report clearly identifies the mutation type, as this directly impacts eligibility for read-through therapy.

Counterforce Health: Streamlining Your Appeal Process

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific basis for denial, and drafts point-by-point rebuttals aligned to your plan's own rules. For complex cases like Translarna, where genetic documentation and regulatory status create unique challenges, we help ensure your appeal includes the right clinical evidence and addresses payer-specific concerns.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Translarna in Georgia? Standard processing takes 2-3 weeks. Expedited review (if medically urgent) typically completes within 72 hours. Always follow up after 5-7 business days to confirm receipt.

What if Translarna is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Include genetic testing, specialist letter, and evidence of medical necessity for this specific therapy.

Can I request expedited appeal if my child's condition is worsening? Yes. Both Aetna internal appeals and Georgia external review offer expedited processes for urgent medical situations, typically completing within 72 hours.

Does step therapy apply if we've tried treatments outside Georgia? Documentation of prior therapy failures from any location should satisfy step therapy requirements. Ensure complete medical records are included with your PA request.

What happens if the Georgia external review supports coverage? The decision is binding on Aetna CVS Health. They must authorize coverage and process claims according to the external reviewer's determination.

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 terms, medical circumstances, and current regulatory status. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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