By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Cigna in New Jersey: Complete Coding & Appeals Guide

Answer Box: Getting Aldurazyme (Laronidase) Covered by Cigna in New Jersey

Aldurazyme (laronidase) requires prior authorization from Cigna and is typically covered under the medical benefit. Your fastest path: 1) Have your specialist submit a PA request through CoverMyMeds or call 1-800-882-4462 with complete MPS I documentation, 2) Use correct billing codes (ICD-10: E76.01/E76.02, HCPCS: J1931), and 3) If denied, appeal within 180 days or use New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services. Start today by confirming your Cigna formulary status and gathering genetic/enzyme testing results.

Table of Contents

Medical vs. Pharmacy Benefit Coverage

Aldurazyme is covered under Cigna's medical benefit, not the pharmacy benefit. This enzyme replacement therapy requires IV infusion administration, making it a medical service rather than a dispensed prescription. Cigna's coverage policy IP0445 confirms this classification as of July 2025.

Key implications:

  • Prior authorization required through medical benefit channels
  • Claims processed under medical deductible and coinsurance
  • Specialty pharmacy (Accredo) handles fulfillment after PA approval
  • Infusion administration codes needed for complete billing
Tip: Always verify benefit type on the member's ID card or by calling Cigna Provider Services at 1-800-882-4462, as some specialty pharmacy arrangements may differ.

Essential ICD-10 Codes for MPS I

Accurate diagnosis coding is critical for Aldurazyme approval. Use the specific MPS I subtype:

Condition ICD-10 Code Documentation Required
Hurler syndrome E76.01 Severe form; early onset symptoms
Hurler-Scheie syndrome E76.02 Intermediate form; most common
Scheie syndrome E76.03 Attenuated form; later onset

Supporting documentation must include:

  • Genetic confirmation of IDUA mutation
  • Alpha-L-iduronidase enzyme activity deficiency results
  • Elevated urinary glycosaminoglycans (dermatan/heparan sulfate)
  • Clinical manifestations by organ system
Note: Don't use generic "MPS I" terminology. Cigna requires the specific syndrome subtype for proper code assignment and coverage determination.

HCPCS J-Code and Billing Requirements

Primary billing code: J1931 - "Injection, laronidase, 0.1 mg"

Unit Calculation Formula

  • Each vial contains: 2.9 mg in 5 mL
  • Billing units: Total mg administered ÷ 0.1 mg = billable units
  • Example: 2.9 mg vial = 29 units (2.9 ÷ 0.1 = 29)

NDC and Administration Codes

  • NDC: 58468-0070-xx (verify current format)
  • Infusion codes: CPT 96365 (first hour), 96366 (additional hours)
  • Modifiers: JW (drug wastage if applicable)

Dosing reference: Standard dose is 0.58 mg/kg weekly, so a 50 kg patient requires 29 mg (290 billing units).

Clean Prior Authorization Request

Required Clinical Information

  1. Confirmed MPS I diagnosis with genetic/enzyme testing results
  2. Weight-based dosing calculation (0.58 mg/kg weekly)
  3. Baseline assessments: Pulmonary function, cardiac status, joint mobility
  4. Treatment goals: Specific clinical endpoints to monitor
  5. Infusion reaction monitoring plan

Submission Methods

  • Electronic PA: CoverMyMeds, ExpressPAth, or EHR integration
  • Phone: 1-800-882-4462 for manual submission
  • Expedited requests: Available for urgent medical situations
Clinician Corner: Include peer-reviewed evidence supporting enzyme replacement therapy efficacy in MPS I, such as FDA labeling data and published clinical trial outcomes. Reference the FDA-approved prescribing information for dosing and safety data.

Common Billing Pitfalls

Error Type Common Mistake Correct Approach
Unit conversion Billing per vial (1 unit) Bill per 0.1 mg (29 units for 2.9 mg vial)
Diagnosis coding Using E76.9 (unspecified) Use specific subtype (E76.01, E76.02, E76.03)
Benefit type Submitting to pharmacy benefit Submit under medical benefit
Authorization timing Billing before PA approval Obtain PA before first infusion
Documentation Missing enzyme testing Include genetic and biochemical confirmation

Most costly error: Unit conversion mistakes can result in significant underbilling or overbilling, triggering audits and recoupment requests.

Cigna Appeals Process in New Jersey

Internal Appeals (Two Levels Required)

  1. First-level appeal: Submit within 180 days of denial
  2. Second-level appeal: If first level denied, automatic second review
  3. Expedited appeals: 72-hour decision for urgent cases

Required Appeal Documents

  • Original denial letter with specific reason codes
  • Updated medical records supporting medical necessity
  • Peer-reviewed literature on MPS I treatment
  • Specialist attestation letter
  • Weight-based dosing calculations

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific coverage criteria. Their platform helps identify whether denials are based on PA criteria, step therapy, or "not medically necessary" determinations.

New Jersey External Review (IHCAP)

After completing Cigna's internal appeals, New Jersey residents can access the Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services.

IHCAP Process

  • Eligibility: Must complete two levels of internal appeals first
  • Timeline: 180 days from final internal denial to submit
  • Cost: Free to patients (insurers pay all fees)
  • Decision: Binding on Cigna if overturned

How to Submit

  1. Contact: IHCAP hotline at 1-888-393-1062
  2. Submit directly to: Maximus Federal Services (not NJ DOBI)
  3. Required documents: Final denial letters, medical records, physician letters
  4. Decision timeline: 45 days for standard review, expedited available
From our advocates: "We've seen many MPS I cases succeed at external review when the initial denial focused on 'experimental' concerns. The key is providing comprehensive genetic testing documentation and citing FDA approval as definitive proof of medical necessity. While outcomes vary, having specialist support and complete medical records significantly improves the chances of a favorable decision."

Success factors: Independent medical experts review cases, and approximately half of external appeals nationwide favor consumers, especially with rare disease documentation.

Pre-Submission Checklist

Before Submitting PA or Appeal

  • Confirm patient has Cigna coverage (check member ID)
  • Verify Aldurazyme formulary status for specific plan
  • Gather genetic testing results confirming IDUA mutation
  • Document enzyme activity deficiency levels
  • Calculate weight-based dosing (0.58 mg/kg weekly)
  • Obtain baseline clinical assessments
  • Prepare infusion site and monitoring plan
  • Use correct codes: ICD-10 (E76.01/02/03), HCPCS (J1931)
  • Submit through appropriate benefit (medical, not pharmacy)

For Appeals, Also Include

  • Original denial letter with reason codes
  • Updated medical records since denial
  • Specialist letter addressing denial reasons
  • Published evidence supporting treatment
  • Documentation of clinical deterioration without treatment

For complex cases, Counterforce Health can help analyze denial patterns and develop targeted appeal strategies based on each payer's specific coverage policies.

FAQ

Q: How long does Cigna prior authorization take for Aldurazyme in New Jersey? A: Electronic submissions often receive decisions within hours to 1-2 business days. Manual submissions may take 3-5 business days. Expedited requests are processed within 72 hours for urgent medical situations.

Q: What if Aldurazyme is non-formulary on my Cigna plan? A: Request a formulary exception through the same PA process. Provide medical necessity documentation showing no formulary alternatives exist for MPS I enzyme replacement therapy.

Q: Can I request an expedited appeal in New Jersey? A: Yes, both Cigna internal appeals and New Jersey's IHCAP offer expedited reviews when delays could cause serious harm to health.

Q: Does step therapy apply to Aldurazyme? A: Generally no, as Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I. However, some plans may require documentation that hematopoietic stem cell transplant is not appropriate.

Q: What's the difference between medical and pharmacy benefit coverage? A: Medical benefit covers infused therapies like Aldurazyme, processed under medical deductible/coinsurance. Pharmacy benefit covers dispensed medications from retail or specialty pharmacies.

Q: How much does Aldurazyme cost without insurance? A: Manufacturer wholesale price is approximately $1,113.38 per 2.9 mg vial as of January 2025. Annual costs can exceed $300,000 depending on patient weight and dosing requirements.

Q: Are there patient assistance programs for Aldurazyme? A: Yes, contact Sanofi Genzyme patient support at 1-800-745-4447 for copay assistance and foundation grant information.

Q: What happens if my New Jersey external review is denied? A: IHCAP decisions are final for state-regulated plans. For self-funded employer plans or Medicare Advantage, different federal appeal rights may apply.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with healthcare providers and insurance representatives for personalized guidance. For assistance with complex appeals, consider consulting with healthcare coverage specialists or patient advocacy organizations.

Need help with your Aldurazyme appeal? Counterforce Health helps patients and clinicians turn insurance denials into successful approvals by analyzing payer policies and crafting evidence-based appeals tailored to each plan's specific requirements.

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