By Counterforce Health Team in Carbaglu (carglumic acid) —

How to Get Carbaglu (Carglumic Acid) Covered by Humana in Virginia: Complete Appeals Guide

Answer Box: Getting Carbaglu Covered by Humana in Virginia

Humana requires prior authorization for Carbaglu (carglumic acid) for NAGS deficiency treatment. In Virginia, you have strong appeal rights through the State Corporation Commission Bureau of Insurance. First steps: 1) Gather genetic confirmation of NAGS deficiency and elevated ammonia labs, 2) Submit PA request with complete medical necessity documentation, 3) If denied, file internal appeal within 65 days, then external review within 120 days using Form 216-A.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory for all Carbaglu coverage Humana PA List Humana Provider
Formulary Status Specialty tier; varies by plan Member portal or formulary guide Humana Formulary
Diagnosis Documentation Genetic/biochemical proof of NAGS deficiency Lab reports, genetic testing FDA Label
Baseline Labs Elevated ammonia, amino acid profile Hospital/clinic records Medical records
Appeals Deadline 65 days for Humana; 120 days for Virginia external review Denial letter Virginia Code

Step-by-Step: Fastest Path to Approval

1. Confirm Diagnosis Documentation

Who does it: Your metabolic specialist
What's needed: Genetic testing showing NAGS gene mutations, elevated plasma ammonia levels, amino acid profile
Timeline: May take 2-4 weeks if testing isn't complete
Source: NAGS deficiency requires biochemical and genetic confirmation

2. Gather Prior Treatment History

Who does it: Patient/family with clinic help
What's needed: Documentation of previous therapies, hospitalizations, ammonia levels over time
How to submit: Request records from all treating facilities
Timeline: 1-2 weeks for record collection

3. Submit Prior Authorization Request

Who does it: Prescribing physician
What's needed: PA form, medical necessity letter, lab results, genetic testing
How to submit: Humana provider portal or fax
Timeline: 30 days for standard review, 72 hours for expedited
Source: Humana PA requirements

4. Track Your Request

Who does it: Patient or clinic staff
What's needed: PA reference number
How to check: Humana member portal or provider line
Timeline: Check weekly if no response after 14 days

5. If Denied: Request Peer-to-Peer Review

Who does it: Prescribing physician
What's needed: Denial letter, clinical rationale
How to request: Call Humana medical management
Timeline: Usually scheduled within 3-5 business days

6. File Internal Appeal if Still Denied

Who does it: Patient, family, or authorized representative
What's needed: Appeal form, denial letter, additional evidence
How to submit: Humana appeals process
Timeline: 65 days from denial notice

7. External Review Through Virginia

Who does it: Patient or representative
What's needed: Form 216-A, denial letters, medical records
How to submit: Mail to SCC Bureau of Insurance
Timeline: 120 days from final denial; decision within 45 days
Source: Virginia external review process

Medical Necessity Documentation

Clinician Corner: Essential Elements for Approval

Your medical necessity letter should include these key components:

Diagnosis Confirmation

  • Genetic testing results showing pathogenic NAGS gene variants
  • Biochemical evidence: elevated plasma ammonia, specific amino acid patterns
  • Normal urine orotic acid (distinguishes from OTC deficiency)
  • Source: NAGS deficiency diagnostic criteria

Clinical History

  • Symptom onset and severity (hyperammonemic episodes, neurological symptoms)
  • Previous hospitalizations and interventions
  • Response to other treatments (if any were tried)

Treatment Rationale

  • Why Carbaglu is specifically indicated for NAGS deficiency
  • Expected outcomes: ammonia reduction, symptom control
  • Monitoring plan for treatment effectiveness

Supporting Evidence

  • FDA-approved indication for NAGS deficiency
  • Peer-reviewed literature on carglumic acid effectiveness
  • Professional society guidelines (when available)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Medical necessity not established" Submit genetic testing and elevated ammonia labs NAGS gene analysis, plasma ammonia levels
"Experimental/investigational" Cite FDA approval for NAGS deficiency FDA label
"Incomplete documentation" Resubmit with all required elements Complete PA packet checklist
"Alternative treatments available" Document why alternatives aren't appropriate Medical contraindications, prior failures

Appeals Process for Humana in Virginia

Internal Appeals with Humana

Level 1: Standard Reconsideration

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for decision (7 days if expedited)
  • How to file: Humana member portal or written request
  • Required: Denial letter, additional medical evidence, appeal form

Level 2: Independent Review

  • When: If Level 1 denied
  • Timeline: 30 days for decision
  • Process: External medical reviewer evaluates case

Virginia External Review

If Humana's internal appeals fail, Virginia offers independent external review:

Eligibility

  • Must complete Humana's internal appeals first
  • Denial must be based on medical necessity or experimental treatment
  • Must be Virginia-issued plan or opted-in self-funded plan

Filing Process

Required Documents

  • Completed Form 216-A
  • Copy of all denial letters
  • Insurance card copy
  • Medical records release form
  • Any new supporting documentation

Timeline

  • Standard review: Decision within 45 days
  • Expedited review: 72 hours if life/health at risk
  • Total process: Cannot exceed 60 days

Success Factors Virginia's external review has helped many patients get coverage for necessary treatments. The independent medical reviewers focus solely on medical necessity without insurance company financial considerations.

Cost Assistance Options

While working through the approval process, explore these cost assistance programs:

Manufacturer Support

  • Contact Recordati Rare Diseases for patient assistance programs
  • May offer free drug or copay assistance during appeals
  • Verify current programs (check manufacturer website)

Foundation Grants

  • National Organization for Rare Disorders (NORD) assistance programs
  • Disease-specific foundations for metabolic disorders
  • State pharmaceutical assistance programs

Temporary Coverage

  • Emergency supplies through hospital pharmacies
  • Compassionate use programs during appeals
  • Short-term coverage while PA is pending

When to Escalate to State Regulators

Contact Virginia regulators if you experience:

  • Unreasonable delays in processing appeals
  • Violations of appeal deadlines
  • Improper denial of expedited reviews for urgent cases

Virginia State Corporation Commission

  • Phone: 1-877-310-6560
  • Consumer Services: Life & Health division
  • Online: File complaints through SCC website
  • What to include: Timeline of events, copies of all correspondence, specific violations
From Our Advocates: We've seen cases where contacting the state insurance department helped resolve delays in processing appeals. One family's expedited review was approved within 48 hours after the state intervened when Humana missed their 72-hour deadline for urgent cases.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right medical evidence and citations to support coverage requests.

FAQ

How long does Humana prior authorization take in Virginia? Standard PA decisions take up to 30 days; expedited reviews are completed within 72 hours when urgent medical need is documented.

What if Carbaglu is non-formulary on my Humana plan? You can request a formulary exception by demonstrating medical necessity and that formulary alternatives are inappropriate. Success rates are lower for non-formulary specialty drugs, but appeals are possible.

Can I request an expedited appeal for Carbaglu? Yes, if your doctor certifies that waiting for standard review could seriously jeopardize your health. Hyperammonemic crises qualify for expedited review.

Does step therapy apply to Carbaglu? Step therapy requirements vary by plan. NAGS deficiency is so rare that there may not be true alternatives, which can exempt you from step therapy requirements.

What happens if Virginia external review denies coverage? The IRO's decision is binding, but you retain rights to legal action. You might also explore federal external review options if applicable to your plan type.

How much does Carbaglu cost without insurance in Virginia? Cash prices can exceed $200 per 200mg tablet. Monthly costs vary significantly based on weight-based dosing requirements. Patient assistance programs may help during appeals.

Can a family member file appeals on my behalf? Yes, with proper authorization. Use Form 216-B if you're not the covered person, and include signed authorization forms with your submission.

What if I'm already taking Carbaglu when I switch to Humana? Humana provides a 90-day transition period for existing treatments, but you should submit PA documentation immediately to avoid coverage gaps.

For additional support navigating the appeals process, Counterforce Health provides tools and guidance to help patients and providers build stronger cases for coverage approval.

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 and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.