How to Get Oxlumo (Lumasiran) Covered by Aetna CVS Health in New Jersey: Complete Prior Authorization and Appeals Guide
Answer Box: Quick Path to Oxlumo Coverage
To get Oxlumo (lumasiran) covered by Aetna CVS Health in New Jersey: Submit prior authorization with confirmed PH1 diagnosis (genetic AGXT testing or liver enzyme analysis), specialist prescription from nephrologist/geneticist, baseline eGFR ≥30 mL/min/1.73m², and urinary oxalate levels. Use HCPCS code J0224 for medical benefit billing. If denied, you have 180 days for internal appeals, then access New Jersey's IHCAP external review through Maximus Federal Services at no cost.
First step today: Call Aetna member services (number on your ID card) to confirm Oxlumo's formulary status and download the Oxlumo precertification form.
Table of Contents
- Coverage Requirements at a Glance
- Step-by-Step: Fastest Path to Approval
- Coding That Gets Claims Paid
- Medical Necessity Documentation
- Common Denial Reasons & Solutions
- Appeals Process in New Jersey
- Cost Support Options
- When to Escalate
- FAQ
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It | Source |
|---|---|---|---|
| Prior Authorization | Required for all Oxlumo prescriptions | Aetna provider portal or precert form | Aetna PA List |
| Specialist Prescriber | Nephrologist or geneticist only | Prescription must show specialist credentials | Aetna Oxlumo Policy |
| Genetic Confirmation | AGXT mutation or liver enzyme analysis | Lab reports showing PH1 diagnosis | Aetna PA Form |
| Kidney Function | eGFR ≥30 mL/min/1.73m² | Recent lab work (within 90 days) | Aetna Clinical Policy |
| Medical Benefit | Billed as provider-administered injection | Uses HCPCS J0224, not pharmacy benefit | CVS Caremark Guidelines |
Step-by-Step: Fastest Path to Approval
1. Verify Coverage and Benefits
Who: Patient or clinic staff
Action: Call Aetna member services (number on insurance card)
Ask about: Oxlumo formulary status, medical vs. pharmacy benefit, copay/deductible
Timeline: 10-15 minutes
2. Gather Required Documentation
Who: Healthcare team
Documents needed:
- Genetic testing results (AGXT mutation) or liver enzyme analysis
- Recent eGFR and creatinine levels
- 24-hour urine oxalate measurements
- Documentation of prior conservative treatments tried/failed
- Specialist consultation notes
Timeline: 1-2 weeks if tests needed
3. Complete Prior Authorization
Who: Prescribing physician or staff
Form: Aetna Oxlumo Precertification Request
Submit via: Fax (888) 267-3277 or call (866) 752-7021
Timeline: Standard 30-45 days, expedited 72 hours if urgent
4. Follow Up and Track Status
Who: Clinic staff
Action: Check Aetna provider portal for status updates
Contact: Provider services if no response within expected timeframe
Timeline: Weekly check-ins during review period
Coding That Gets Claims Paid
Medical Benefit Billing (Most Common)
- HCPCS Code: J0224 (Injection, lumasiran, 0.5 mg)
- Units Calculation: Total mg dose ÷ 0.5 = billable units
- Example: 94.5 mg dose = 189 units of J0224
- Administration: CPT 96372 (subcutaneous injection)
- ICD-10: E72.530 (Primary hyperoxaluria type 1)
Tip: Always use the 11-digit NDC format (71336-1002-01) and document exact weight-based dosing calculations to avoid unit conversion errors.
Dosing and Volume Guidelines
| Weight Range | Loading Dose | Maintenance | Vials Needed |
|---|---|---|---|
| <10 kg | 6 mg/kg monthly ×3 | 3 mg/kg monthly | Calculate per dose |
| 10-<20 kg | 6 mg/kg monthly ×3 | 6 mg/kg quarterly | 1-2 vials typical |
| ≥20 kg | 3 mg/kg monthly ×3 | 3 mg/kg quarterly | 1-3 vials per dose |
Volume limits: Maximum 1.5 mL per injection site; split larger volumes into multiple sites ≥2 cm apart.
Medical Necessity Documentation
Clinician Corner: Essential Elements
Your medical necessity letter should address these key points:
Diagnosis Confirmation:
- Genetic testing results showing biallelic AGXT mutations
- OR liver enzyme analysis demonstrating absent/reduced AGT activity
- 24-hour urine oxalate levels (typically >0.5 mmol/1.73m²/day)
- Evidence of nephrocalcinosis or kidney stones on imaging
Prior Treatments:
- Conservative measures tried: high fluid intake (>3L/m²/day)
- Pyridoxine trial and response (document 30% reduction if responsive)
- Potassium citrate supplementation
- Dietary oxalate restriction attempts
Clinical Rationale:
- Current eGFR and CKD stage
- Risk of progression to ESRD (occurs in >70% of PH1 patients)
- Treatment goals: reduce urinary oxalate, preserve kidney function
- Monitoring plan: quarterly urinary oxalate, eGFR tracking
Common Denial Reasons & Solutions
| Denial Reason | How to Overturn | Required Documents |
|---|---|---|
| "Genetic confirmation insufficient" | Submit comprehensive genetic report | AGXT mutation analysis from certified lab |
| "Not prescribed by specialist" | Transfer care or obtain consultation | Nephrologist or geneticist prescription |
| "eGFR too low" | Document current kidney function | Recent labs showing eGFR ≥30 mL/min/1.73m² |
| "Experimental/investigational" | Cite FDA approval | FDA approval letter and prescribing information |
| "Step therapy not met" | Document conservative treatment failures | Treatment logs, medication trials, response data |
Appeals Process in New Jersey
Internal Appeals (Required First Step)
Level 1 Appeal:
- Deadline: 180 days from denial
- Timeline: 30-45 days for standard, 72 hours for expedited
- Submit via: Aetna provider portal or written request
- Include: Original PA, additional clinical evidence, peer-reviewed literature
Level 2 Appeal:
- Deadline: 60 days from Level 1 denial
- Process: Automatic review by different medical reviewer
- Consider: Peer-to-peer review request with prescribing physician
External Review Through IHCAP
New Jersey's Independent Health Care Appeals Program (IHCAP) provides free external review for medical necessity denials.
Eligibility:
- Completed both levels of internal appeals
- Denial based on medical necessity or experimental status
- Filed within 180 days of final internal denial
Process:
- Submit Request for External Review to Aetna's External Review Unit
- Maximus Federal Services conducts independent physician review
- Decision made within 45 days (expedited available for urgent cases)
- Decision is binding on Aetna
Contact IHCAP:
- Phone: 1-888-393-1062
- Website: NJ Department of Banking and Insurance
Note: Providers can file external appeals on behalf of patients with consent, and appeals can be filed for services already provided and denied.
Cost Support Options
Manufacturer Assistance
- Alnylam Assist: 1-833-256-2748
- Services: Insurance navigation, copay support, free drug program eligibility
- Website: Contact through prescriber or patient services
Foundation Support
- Patient Advocate Foundation: Copay relief for qualifying patients
- National Organization for Rare Disorders (NORD): Patient assistance programs
- HealthWell Foundation: Financial assistance for rare diseases
State Resources
- New Jersey residents may qualify for additional state pharmaceutical assistance programs
- Contact NJ Department of Human Services for eligibility screening
When to Escalate
Contact New Jersey regulators if you experience:
- Repeated inappropriate denials despite meeting criteria
- Failure to meet appeal deadlines
- Lack of response to external review decisions
New Jersey Department of Banking and Insurance:
- Consumer Hotline: 1-800-446-7467
- Online complaint portal available
- Managed Care Ombudsman for additional support
Frequently Asked Questions
Q: How long does Aetna prior authorization take for Oxlumo in New Jersey? A: Standard PA decisions take 30-45 days. Expedited reviews (for urgent medical situations) are completed within 72 hours.
Q: What if Oxlumo is non-formulary on my Aetna plan? A: Submit a formulary exception request with medical necessity documentation. Aetna must review non-formulary requests when medically necessary alternatives aren't available.
Q: Can I request an expedited appeal? A: Yes, if a delay in treatment would seriously jeopardize your health. Contact Aetna at 1-844-362-0934 for expedited appeals.
Q: Does step therapy apply if I tried treatments outside New Jersey? A: Out-of-state treatment records are valid. Provide complete documentation of prior therapies and outcomes from all treating physicians.
Q: What happens if IHCAP overturns Aetna's denial? A: Aetna must comply with the external review decision and provide coverage. This decision is legally binding under New Jersey law.
Q: How much does Oxlumo cost without insurance? A: The average annual list price is approximately $493,000, with individual vial costs around $60,099 (94.5 mg). Manufacturer assistance programs may help reduce out-of-pocket costs.
Q: Can I appeal if my doctor isn't a specialist? A: Transfer care to a nephrologist or geneticist, or request a specialist consultation. Aetna requires specialist prescribing for Oxlumo approval.
About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address the specific reasons for coverage denials. For complex cases like rare disease treatments, having the right documentation and appeal strategy can make the difference between approval and denial.
Sources & Further Reading
- Aetna Oxlumo Clinical Policy Bulletin
- Aetna Oxlumo Precertification Form
- FDA Oxlumo Prescribing Information
- New Jersey IHCAP Information
- Aetna Provider Appeals Process
- Oxlumo Dosing and Administration Guide
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 your healthcare provider and insurance plan for specific guidance. For additional help with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.
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