By Counterforce Health Team in Carbaglu (carglumic acid) —

How to Get Carbaglu (Carglumic Acid) Covered by Aetna CVS Health in Washington: Complete PA Guide with Appeals Process

Answer Box: Getting Carbaglu (Carglumic Acid) Covered by Aetna CVS Health in Washington

Fastest path to approval: Submit prior authorization with confirmed NAGS deficiency diagnosis (genetic/enzyme testing) plus baseline elevated ammonia levels. Aetna requires 12-month PA for all FDA-approved indications. If denied, file internal appeal within 180 days, then request Washington IRO external review if needed.

First step today: Call Aetna at the number on your card to confirm formulary status and obtain PA forms. For urgent cases (acute hyperammonemia), request expedited review.

Table of Contents

  1. Coverage at a Glance
  2. Reading Your Aetna Denial Letter
  3. Fixable Causes Before Appeals
  4. Prior Authorization Requirements
  5. First-Level Internal Appeal
  6. Peer-to-Peer Review Process
  7. Washington External Review (IRO)
  8. Appeal Templates and Scripts
  9. When to Escalate to State Regulators
  10. Cost Assistance Options
  11. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all indications Aetna Specialty Drug List Aetna Clinical Policy
Formulary Status Specialty drug, outpatient only Member portal/benefits booklet Aetna Policy 2122-A
Covered Indications NAGS deficiency, PA/MMA acute hyperammonemia FDA label FDA Access Data
Required Documentation Genetic/enzyme testing + baseline ammonia PA form Aetna Clinical Policy
Appeal Deadline 180 days from denial Plan documents WA OIC Appeals Guide
External Review Washington IRO process Final denial letter WA Insurance Code

Reading Your Aetna Denial Letter

When Aetna denies Carbaglu coverage, your denial letter will specify the exact reason. Common denial codes include:

  • "Not medically necessary" - Usually means missing diagnostic confirmation
  • "Experimental/investigational" - Often applies to off-label uses
  • "Step therapy not met" - Rare for NAGS deficiency but possible
  • "Non-formulary" - May require formulary exception process
Critical: The denial letter contains your appeal deadline (typically 180 days) and submission instructions. Don't rely on verbal information—everything must be in writing.

Your letter should also indicate whether you have a fully insured plan (regulated by Washington OIC) or self-funded/ERISA plan (federal external review). This determines your appeal path after internal levels are exhausted.

Fixable Causes Before Appeals

Before filing an appeal, check if these common issues can resolve your denial:

Missing Documentation

  • Genetic testing results confirming NAGS deficiency
  • Baseline ammonia levels (elevated, pre-treatment)
  • ICD-10 diagnosis code E72.2 (Disorders of urea cycle metabolism)
  • Prescriber specialty (genetics, metabolism, or pediatrics)

Coding Issues

  • Ensure diagnosis matches Aetna's covered indications exactly
  • Verify HCPCS code J7518 for billing if applicable
  • Confirm NDC numbers match approved formulations

Benefit vs. Medical Policy

Carbaglu may be covered under pharmacy benefit (CVS Caremark) or medical benefit depending on your plan. Contact member services to clarify which applies to your coverage.

Prior Authorization Requirements

FDA-Approved Indications Covered by Aetna

Aetna covers Carbaglu for:

  1. Acute hyperammonemia due to NAGS deficiency (adjunctive therapy)
  2. Chronic hyperammonemia due to NAGS deficiency (maintenance therapy)
  3. Acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA)

All other uses are considered experimental and not covered.

Required Documentation for Initial PA

For NAGS deficiency (both criteria required):

  • Confirmed diagnosis supported by enzyme assay, biochemical testing, or genetic testing
  • Elevated baseline plasma ammonia levels

For PA/MMA:

  • Confirmed diagnosis of propionic acidemia or methylmalonic acidemia

Submission Process

Submit PA requests via:

  • Aetna Provider Portal (preferred)
  • Fax: 1-855-330-1716 (verify current number with Aetna)
  • Phone: 1-866-814-5506 for specialty drug inquiries

Review timelines:

  • Standard: 30-45 days
  • Expedited (acute hyperammonemia): ≤72 hours

First-Level Internal Appeal

If your PA is denied, you have the right to appeal. Here's what to include in your appeal letter:

Medical Necessity Letter Checklist

Your prescriber should address:

  • Confirmed diagnosis with supporting test results
  • Clinical presentation and severity of hyperammonemia
  • Prior treatments tried and outcomes/failures
  • Why Carbaglu is medically necessary for this patient
  • Treatment goals and expected outcomes
  • Dosing rationale based on FDA labeling

Supporting Evidence to Attach

  • Copy of denial letter
  • Complete medical records related to diagnosis
  • Genetic/enzyme testing results
  • Ammonia level lab reports
  • FDA prescribing information highlighting approved use
  • Any relevant clinical guidelines or literature
Tip: For NAGS deficiency cases, emphasize the rarity of the condition and lack of alternative treatments. Include any specialist consultation notes.

Peer-to-Peer Review Process

Aetna offers peer-to-peer (P2P) reviews where your prescriber can discuss the case directly with an Aetna medical director.

How to Request P2P

For specialty drug PAs (CVS Caremark):

  • Call 1-800-294-5979 and request discussion with a clinical peer

For Aetna specialty drug list items:

  • Call 1-866-814-5506 or use the number in your denial letter

P2P Timing

  • Must be requested before final determination for pre-service cases
  • Usually available within 24-48 hours of request
  • Not required for appeals but can be requested as part of appeal process

Preparing for P2P

Have ready:

  • Complete clinical summary
  • All supporting lab/genetic test results
  • FDA labeling and clinical guidelines
  • Documentation of prior therapy failures (if applicable)

Washington External Review (IRO)

If Aetna upholds your denial after internal appeals, Washington residents with fully insured plans can request Independent Review Organization (IRO) external review.

Eligibility and Process

  • Available after completing required internal appeals
  • Must request within timeframe specified in final denial letter (often 180 days)
  • IRO decision is binding on Aetna

How to Request IRO Review

Your final denial letter from Aetna will explain:

  • Whether IRO review is available for your plan
  • How and where to submit the request
  • Required forms and documentation

For help navigating the process, contact: Washington OIC Consumer Advocacy: 1-800-562-6900

IRO Timeline

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases

Appeal Templates and Scripts

Patient Phone Script for Aetna

"Hi, I'm calling about a denied prior authorization for Carbaglu. My member ID is [ID number]. I need to understand the specific reason for denial and how to file an internal appeal. Can you also confirm if peer-to-peer review is available and provide the appeal submission address or portal?"

Medical Necessity Letter Template

Dear Aetna Medical Director,

I am writing to appeal the denial of Carbaglu (carglumic acid) for [patient name], DOB [date], Member ID [number].

This patient has confirmed NAGS deficiency diagnosed by [genetic testing/enzyme assay/biochemical testing] performed on [date]. Baseline ammonia levels were elevated at [value] on [date], consistent with this rare metabolic disorder.

Carbaglu is FDA-approved specifically for this indication and is considered standard of care. There are no therapeutic alternatives for NAGS deficiency. [Continue with specific clinical details...]

Counterforce Health can help streamline this process by analyzing your denial letter, identifying the specific criteria Aetna cited, and drafting a targeted medical necessity letter that addresses each point systematically. Their platform pulls the right clinical evidence and weaves it into appeals that meet payer-specific requirements.

When to Escalate to State Regulators

Contact Washington OIC if you encounter:

  • Unreasonable delays in appeal processing
  • Denial of expedited review for urgent cases
  • Failure to provide required appeal information
  • Suspected bad faith claims handling

Washington OIC Consumer Advocacy: 1-800-562-6900

You can also file complaints online through the OIC complaints portal.

Cost Assistance Options

Manufacturer Support

Recordati Rare Diseases offers patient assistance programs. Contact their patient services for eligibility screening.

Copay Assistance

Check if your plan allows manufacturer copay cards for specialty medications.

Foundation Grants

Organizations like the National Organization for Rare Disorders (NORD) provide financial assistance for rare disease medications.

FAQ

Q: How long does Aetna PA take for Carbaglu in Washington? A: Standard PA decisions take 30-45 days. Expedited reviews for acute hyperammonemia are completed within 72 hours.

Q: What if Carbaglu is non-formulary on my plan? A: You can request a formulary exception by demonstrating medical necessity and lack of covered alternatives for NAGS deficiency.

Q: Can I request expedited appeal if my condition is stable? A: Expedited appeals are for situations where delay could seriously jeopardize health. Stable patients typically use standard appeal timelines.

Q: Does step therapy apply to Carbaglu? A: Step therapy is rare for NAGS deficiency since there are no therapeutic alternatives, but some plans may require trial of ammonia scavengers first.

Q: What happens if the IRO upholds Aetna's denial? A: IRO decisions are final and binding. Your remaining options would be legal action or seeking alternative coverage sources.

From our advocates: We've seen NAGS deficiency cases initially denied for "lack of medical necessity" get approved on appeal when genetic testing and baseline ammonia levels were clearly documented. The key is having your metabolic specialist write a detailed letter explaining why Carbaglu is the only effective treatment for this ultra-rare condition. Most denials stem from incomplete documentation rather than true coverage exclusions.

For complex rare disease appeals like Carbaglu, Counterforce Health specializes in turning insurance denials into successful appeals by identifying the exact coverage criteria and drafting evidence-backed rebuttals that address payer-specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan documents for specific coverage details. For assistance with appeals, contact the Washington Office of the Insurance Commissioner at 1-800-562-6900.

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