By Counterforce Health Team in Carbaglu (carglumic acid) —

How to Get Carbaglu (Carglumic Acid) Covered by Blue Cross Blue Shield in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Carbaglu Covered by BCBS Virginia

Carbaglu (carglumic acid) requires prior authorization from Anthem Blue Cross Blue Shield Virginia for NAGS deficiency. Your fastest path to approval: 1) Verify your plan's formulary status at Anthem's Virginia drug list page, 2) Submit PA with genetic testing confirming NAGS deficiency and hyperammonemia documentation via your provider portal, and 3) If denied, file internal appeal within 60 days citing Virginia Code § 38.2-3407.9:05 for step therapy overrides. External reviews through Virginia's Bureau of Insurance overturn 35-55% of specialty drug denials.

Table of Contents

Plan Types & Coverage Implications

Anthem Blue Cross Blue Shield operates multiple plan types in Virginia, each with different coverage rules for specialty medications like Carbaglu:

Commercial Plans (Individual/Group): Follow state-regulated formularies with Virginia step therapy override protections under Virginia Code § 38.2-3407.9:05. These plans must honor your right to appeal step therapy requirements.

HealthKeepers Plus (Medicaid): Uses Virginia DMAS Preferred Drug List plus plan-specific formulary. Check Virginia DMAS prescription drug formularies for current coverage status.

Medicare Advantage: Follows federal Medicare formulary rules. Prior authorization criteria may differ from commercial plans, requiring separate verification through your specific plan's formulary.

Note: Self-funded ERISA employer plans may not follow Virginia state protections. Verify your plan type by calling the member services number on your ID card.

Formulary Status & Tier Placement

Carbaglu's coverage varies by your specific Anthem Virginia plan. To check your formulary status:

  1. Visit Anthem's Virginia pharmacy information page
  2. Select your plan type (Essential, National, Traditional, etc.)
  3. Search for "CARBAGLU" or "carglumic acid" in the PDF

Typical Classifications:

  • Specialty Tier: High copay/coinsurance (often 25-40% after deductible)
  • Prior Authorization Required: Clinical review before approval
  • Limited Distribution: Must use specific specialty pharmacies

Prior Authorization Requirements

Based on FEP Blue's policy, Anthem Virginia typically requires:

Required Documentation

  • Genetic testing confirming NAGS deficiency
  • Laboratory evidence of hyperammonemia (elevated ammonia levels)
  • Specialist consultation from metabolic or pediatric genetic specialist
  • Weight-based dosing justification within FDA-approved ranges
  • Monitoring plan for ammonia levels and clinical response

Approved Diagnoses

  1. N-acetylglutamate synthase (NAGS) deficiency
  2. Propionic acidemia (PA)
  3. Methylmalonic acidemia (MMA)
Clinician Corner: Your medical necessity letter should address the specific metabolic defect, document hyperammonemic episodes, and explain why dietary protein restriction alone is insufficient. Include baseline ammonia levels and target ranges for monitoring.

Specialty Pharmacy Network

Important: Carbaglu is exclusively distributed through Accredo specialty pharmacy, which is not in Anthem Virginia's standard specialty network. This creates a coverage challenge requiring special coordination.

Anthem Virginia's Specialty Network includes:

  • BioPlus Specialty Pharmacy
  • CenterWell Pharmacy
  • CVS Specialty
  • CareMed Specialty Pharmacy

Patient Setup Process

  1. Download the CARBAGLU Prescription & Enrollment Form
  2. Complete and fax to Accredo at 1-888-454-8488
  3. Contact Anthem member services to arrange out-of-network coverage
  4. Accredo handles prior authorization submission and home delivery

For emergency orders, hospitals can call Accredo wholesale at 1-877-900-9223.

Step-by-Step: Fastest Path to Approval

Step 1: Verify Coverage (1-2 days)

Who: Patient or clinic staff
Action: Call member services (number on ID card) to confirm Carbaglu coverage and PA requirements
Document: Note reference number and representative name

Step 2: Gather Documentation (3-5 days)

Who: Clinical team
Required:

  • Genetic test results confirming NAGS deficiency
  • Recent ammonia levels and metabolic panel
  • Specialist consultation notes
  • Prior therapy documentation (if applicable)

Step 3: Submit Prior Authorization (Same day)

Who: Prescribing physician
Method: Anthem provider portal or CoverMyMeds
Timeline: 72 hours standard, 24 hours expedited

Step 4: Coordinate Specialty Pharmacy (1-2 days)

Who: Patient with clinic support
Action: Submit Accredo enrollment form while PA is pending
Timeline: Accredo setup typically 24-48 hours once approved

Step 5: Monitor Decision (3-5 days)

Who: Clinic staff
Action: Track PA status through provider portal
Backup: Call Anthem provider services if delayed

Common Denial Reasons & Fixes

Denial Reason How to Fix Documentation Needed
Diagnosis not confirmed Submit genetic testing NAGS gene mutation analysis, enzyme assay
Missing lab values Provide ammonia levels Recent metabolic panel with hyperammonemia
Off-label use Cite FDA labeling FDA prescribing information
Step therapy required Request override Prior therapy failures, contraindications
Not medically necessary Submit specialist letter Metabolic specialist attestation
From our advocates: We've seen cases where initial denials were overturned simply by submitting the complete genetic testing panel. Don't assume the first "no" is final—BCBS often approves on appeal when all documentation is provided. These composite experiences show the importance of thorough initial submissions.

Appeals Process in Virginia

Virginia provides strong consumer protections for specialty drug denials through a structured appeals process.

Internal Appeals

Timeline: File within 60 days of denial
Response: BCBS has 30 days to respond (72 hours for expedited)
Method: Submit through provider portal or member services

Required Documentation:

  • Original denial letter
  • Additional clinical evidence
  • Peer-reviewed studies supporting use
  • Specialist letters

External Review

After exhausting internal appeals, Virginia's Bureau of Insurance provides independent review.

Eligibility: Medical necessity denials from state-regulated plans
Timeline: File within 120 days of final internal denial
Form: Form 216-A External Review Request
Contact: 1-877-310-6560

Success Rates: Virginia external reviews overturn 35-55% of specialty drug denials, with Independent Review Organizations providing binding decisions.

Step Therapy Override Rights

Virginia Code § 38.2-3407.9:05 mandates override processes for:

  • Prior treatment failure with adequate trial
  • Medical contraindications
  • Prescriber determination of superior outcomes
  • Current stability on requested medication

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and drafting evidence-backed appeals. Their platform identifies specific denial reasons and creates targeted rebuttals aligned to each plan's criteria, significantly improving approval rates for specialty medications like Carbaglu.

Cost Assistance Programs

Manufacturer Support

Recordati Rare Diseases offers patient assistance through their support program. Contact 1-888-454-8860 for eligibility screening.

Foundation Grants

  • National Organization for Rare Disorders (NORD): Provides grants for rare disease medications
  • HealthWell Foundation: Offers copay assistance for eligible patients
  • Patient Access Network (PAN) Foundation: Disease-specific funds available

Virginia State Programs

Contact Virginia's Bureau of Insurance Consumer Services at 1-877-310-6560 for information about state assistance programs.

When to Escalate

Contact Virginia regulators if you experience:

  • Repeated inappropriate denials
  • Failure to respond within required timelines
  • Violation of step therapy override rights
  • Discrimination based on rare disease diagnosis

Virginia State Corporation Commission
Bureau of Insurance
Phone: 1-877-310-6560
Email: [email protected]

Managed Care Ombudsman
Assists with HMO and managed care issues
Same contact information as Bureau of Insurance

FAQ

How long does BCBS prior authorization take in Virginia?
Standard PA decisions: 72 hours. Expedited (urgent medical need): 24 hours. Complex cases may take up to 14 days with additional documentation requests.

What if Carbaglu is non-formulary on my plan?
Request a formulary exception through your provider. Submit medical necessity documentation and specialist letters supporting the need for this specific medication.

Can I get expedited approval for Carbaglu?
Yes, if your physician certifies that delay could seriously jeopardize your health. Hyperammonemic crises qualify for expedited review.

Does step therapy apply if I've failed similar medications outside Virginia?
Yes, prior treatment failures under other insurers count toward step therapy requirements. Document all previous therapies and outcomes.

How much does Carbaglu cost with BCBS coverage?
Costs vary by plan. Specialty tier copays typically range from 25-40% coinsurance after deductible. Contact member services for your specific cost-sharing.

What happens if my external review is denied?
The IRO decision is final and binding. You may pursue legal options separately or explore alternative funding through manufacturer programs or foundations.

For additional support navigating complex prior authorization requirements, Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy and payer-specific strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies change frequently. Always verify current requirements with your specific plan and consult your healthcare provider for medical decisions. For official guidance on Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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