By Counterforce Health Team in Oxervate (cenegermin) —

How to Get Oxervate (Cenegermin) Covered by Aetna CVS Health in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Oxervate (Cenegermin) Covered by Aetna CVS Health in Pennsylvania

Aetna CVS Health requires prior authorization for Oxervate (cenegermin) in Pennsylvania with strict step therapy requirements. To get approved: 1) Confirm stage 2 or 3 neurotrophic keratitis diagnosis with an ophthalmologist, 2) Document failed trials of at least two preservative-free artificial tears (≥14 days each), 3) Submit PA via CVS Caremark provider portal. Standard decisions take 30-45 days; expedited reviews 72 hours. If denied, use Pennsylvania's state external review program—it overturns ~50% of denials. Start gathering clinical records today.

Table of Contents

Coverage Basics

Is Oxervate covered by Aetna CVS Health? Yes, but it's on the specialty tier with high cost-sharing and requires prior authorization. Oxervate (cenegermin) is covered for FDA-approved indications—specifically stage 2 or 3 neurotrophic keratitis in patients ≥2 years old.

Which Aetna plans cover it? Most commercial Aetna plans include Oxervate on their formulary, but coverage varies by employer group. Check your specific formulary or call member services using the number on your insurance card.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before filling Aetna PA portal
Formulary Tier Specialty (highest copay) Plan benefit summary
Step Therapy 2+ artificial tear failures Clinical documentation
Prescriber Limit Ophthalmologist required PA submission form
Age Restriction ≥2 years old FDA labeling
Quantity Limit 8-week course per eye Aetna policy guidelines

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm Diagnosis (Ophthalmologist)
    • Document stage 2 or 3 neurotrophic keratitis
    • Test corneal sensitivity (cotton wisp or aesthesiometer)
    • Use ICD-10 code H16.239
  2. Gather Documentation (Clinic Staff)
    • Clinical notes with staging details
    • Failed artificial tear trials (≥14 days each)
    • Corneal sensitivity test results
    • Previous treatment history
  3. Submit Prior Authorization (Provider)
  4. Track Status (Patient/Provider)
    • Standard review: 30-45 days
    • Expedited review: 72 hours
    • Check portal for updates or additional requests
  5. If Approved (Patient)
    • Fill at CVS Specialty or approved pharmacy
    • Confirm copay assistance eligibility
    • Schedule follow-up appointments
  6. If Denied (See Appeals Section)
    • Request peer-to-peer review within 5 days
    • File internal appeal within 180 days
    • Consider external review through Pennsylvania
  7. Start Treatment (Patient)
    • 1 drop to affected eye 6 times daily
    • Continue for 8 weeks as prescribed
    • Monitor for improvement with ophthalmologist

Medical Necessity Requirements

Aetna requires comprehensive documentation to establish medical necessity for Oxervate. Your ophthalmologist must provide:

Required Clinical Documentation

  • Confirmed diagnosis of stage 2 or 3 neurotrophic keratitis
  • Corneal sensitivity testing showing decreased sensation
  • Fluorescein staining demonstrating persistent epithelial defect (stage 2) or stromal ulceration (stage 3)
  • Treatment history showing inadequate response to conservative measures
  • Medical necessity letter explaining why Oxervate is appropriate
Clinician Corner: Medical Necessity Letter Checklist

✓ Patient demographics and diagnosis (ICD-10: H16.239)
✓ Clinical findings: corneal sensitivity, epithelial defect size/duration
✓ Prior treatments tried and failed (specific artificial tears, duration)
✓ Risk of progression without treatment
✓ Expected treatment duration and monitoring plan
✓ Reference to FDA labeling and clinical evidence

Step Therapy and Documentation

Aetna requires documented failure of conservative treatments before approving Oxervate. This step therapy protocol must include:

Mandatory Prior Treatments

  1. At least two preservative-free artificial tears (≥14 days each)
    • Document specific products used
    • Note frequency of administration
    • Record patient response/tolerance
  2. Additional supportive measures may include:
    • Lubricating ointments
    • Punctal plugs
    • Bandage contact lenses
    • Protective eyewear

Documentation Requirements

  • Exact dates of treatment trials
  • Specific products/interventions used
  • Patient response and reasons for discontinuation
  • Clinical notes from each follow-up visit
Note: Tarsorrhaphy (surgical eyelid closure) is not typically required before Oxervate approval but may be considered in severe cases where other interventions have failed.

Costs and Financial Assistance

Expected Out-of-Pocket Costs

  • Specialty tier copay/coinsurance: Typically 20-50% of drug cost
  • Oxervate wholesale cost: Approximately $40,000+ for 8-week course
  • Your actual cost: Depends on plan design and assistance programs

Manufacturer Assistance

Dompé CONNECT to Care program offers:

  • Commercial insurance copay assistance (up to $100/month for eligible patients)
  • Patient assistance program for uninsured/underinsured
  • Prior authorization support services

Additional Resources

  • Pennsylvania pharmaceutical assistance programs (verify eligibility at pa.gov)
  • Foundation grants for rare disease treatments
  • Hospital charity care programs if treatment is administered in clinic

Common Denial Reasons

Understanding why Aetna denies Oxervate requests helps you prepare a stronger submission:

Denial Reason How to Overturn
Insufficient diagnosis documentation Submit detailed slit-lamp findings, corneal sensitivity tests, staging photos
Inadequate step therapy Provide comprehensive records of failed artificial tear trials with dates/outcomes
Non-formulary status Request formulary exception with medical necessity letter
Experimental/investigational Reference FDA approval and clinical trial data from submission
Quantity/duration limits Justify extended treatment based on clinical response and guidelines

Appeals Process in Pennsylvania

Pennsylvania offers robust appeal rights with a state-run external review program that has achieved significant success for patients.

Internal Appeals (Aetna)

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for standard; 72 hours for expedited
  • Submit via: Aetna member portal or written appeal
  • Required documents: Denial letter, medical records, physician statement

External Review (Pennsylvania)

Pennsylvania launched its Independent External Review Program in January 2024, providing state oversight of insurance appeals.

  • Eligibility: After exhausting internal appeals
  • Deadline: 4 months from final denial
  • Cost: Free to patients
  • Success rate: ~50% of appeals overturned in first year
  • Timeline: 45 days for standard; 72 hours for expedited

How to File External Review

  1. Obtain Final Adverse Benefit Determination from Aetna
  2. Complete external review form (available at pa.gov)
  3. Submit supporting documentation within 15 days
  4. Independent Review Organization (IRO) reviews case
  5. Decision is binding on Aetna
From Our Advocates: In our experience helping patients with rare disease denials, the key to successful appeals is comprehensive documentation. One patient's Oxervate appeal was initially denied for "insufficient step therapy," but we helped gather detailed records showing six months of failed artificial tear trials. The external review overturned the denial within 30 days, and the patient began treatment immediately.

Specialty Pharmacy Requirements

Aetna typically requires Oxervate to be filled through CVS Specialty pharmacy or other approved specialty pharmacies.

Why Specialty Pharmacy?

  • Temperature-controlled storage requirements
  • Patient education and monitoring
  • Coordination with insurance benefits
  • Clinical support services

What to Expect

  • Transfer notification: Your prescription may be automatically transferred
  • Contact from pharmacy: Expect calls to coordinate delivery
  • Insurance verification: Pharmacy handles prior authorization follow-up
  • Delivery scheduling: Coordinate timing with your treatment plan

Troubleshooting Common Issues

Portal Problems

  • CVS Caremark portal down: Call provider services at number on your Aetna card
  • Missing forms: Download latest versions from Aetna provider resources
  • Upload failures: Try smaller file sizes or different browsers

Communication Issues

  • No response to PA: Follow up after 30 days; request expedited review if urgent
  • Conflicting information: Get clarification in writing via secure message
  • Provider disputes: Request peer-to-peer review with medical director

For complex cases or if you need assistance navigating the appeals process, Counterforce Health specializes in turning insurance denials into successful appeals. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by creating targeted, evidence-backed appeals that align with each payer's specific requirements.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take in Pennsylvania? Standard reviews take 30-45 days, while expedited reviews for urgent cases are completed within 72 hours. Submit complete documentation to avoid delays.

What if Oxervate is non-formulary on my plan? Request a formulary exception with a detailed medical necessity letter. Include evidence that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal if my Oxervate is denied? Yes, if there's immediate risk of vision loss or corneal damage. Your ophthalmologist must document the urgent medical need.

Does step therapy apply if I failed treatments outside Pennsylvania? Yes, but you must provide documentation of those treatment failures. Out-of-state medical records are acceptable with proper verification.

What's the difference between internal and external appeals? Internal appeals are reviewed by Aetna; external appeals are reviewed by independent physicians through Pennsylvania's state program. External reviews have higher overturn rates.

How much will Oxervate cost with Aetna coverage? Costs depend on your plan's specialty tier design. With manufacturer assistance, eligible patients may pay as little as $100/month. Check with your plan for specific copay/coinsurance amounts.

Can I appeal if my 8-week course isn't enough? Yes, request re-authorization with clinical documentation showing partial improvement and need for continued treatment. Some patients require extended courses.

What if CVS Specialty doesn't have Oxervate in stock? Contact your prescriber to request an exception allowing fills at alternative specialty pharmacies. This should not delay your treatment.

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 for personalized guidance. Coverage policies and requirements may change; verify current information with your insurer.

If you're struggling with a complex denial or need professional assistance with your appeal, consider reaching out to Counterforce Health, which specializes in helping patients navigate insurance challenges for specialty medications like Oxervate.

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