By Counterforce Health Team in Oxervate (cenegermin) —

How to Get Oxervate (Cenegermin) Covered by Blue Cross Blue Shield in Florida: Complete Prior Authorization Guide

Answer Box: Getting Oxervate Approved by Florida Blue

Florida Blue requires prior authorization (PA) for Oxervate (cenegermin) with specific criteria: confirmed stage 2 or 3 neurotrophic keratitis, documented failure of preservative-free artificial tears for ≥2 weeks, and corneal sensitivity testing results. Submit PA via Availity.com or call 1-877-719-2583. First step today: Have your ophthalmologist gather corneal photos showing epithelial defects, prior therapy records, and complete the medical necessity letter addressing all criteria before submission.

Table of Contents

Florida Blue's Coverage Policy for Oxervate

Florida Blue (Blue Cross Blue Shield of Florida) covers Oxervate under their Medical Coverage Guideline MCG 09-J3000-15, which deems it medically necessary for specific neurotrophic keratitis cases. The drug requires prior authorization across all Florida Blue plan types—HMO, PPO, and Medicare Advantage—except in emergency rooms, inpatient hospitals, or urgent care centers.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all outpatient settings Florida Blue PA Portal
Formulary Status Specialty tier (varies by plan) Member medication guide
Quantity Limit 8 kits per affected eye per lifetime MCG 09-J3000-15
Age Restriction 2 years and older FDA labeling
Diagnosis Required Stage 2 or 3 neurotrophic keratitis Mackie classification
Appeal Deadline 180 days from denial Florida insurance law

Medical Necessity Requirements

Florida Blue follows strict criteria based on the Mackie classification system for neurotrophic keratitis staging:

Required Diagnosis Documentation

  • Stage 2: Persistent epithelial defect lasting >2 weeks
  • Stage 3: Corneal ulceration with stromal involvement
  • Corneal sensitivity testing using Cochet-Bonnet esthesiometer (≤4 cm in ≥1 quadrant)
  • Slit-lamp examination with fluorescein staining showing defect size/location
  • Visual acuity measurement (best-corrected distance visual acuity)
  • Underlying etiology documentation (diabetes, herpes simplex, surgical trauma, etc.)
Clinician Corner: Include high-quality corneal photographs showing epithelial defects before and after conservative treatment attempts. These visual proofs significantly strengthen PA submissions and reduce denial rates.

Medical Necessity Letter Checklist

Your ophthalmologist should address these elements:

  1. Problem statement: Stage 2/3 NK diagnosis with Mackie classification
  2. Treatment history: Failed conservative measures with specific durations
  3. Clinical rationale: FDA-approved indication for neurotrophic keratitis
  4. Dosing plan: 1 drop to affected eye(s) 6 times daily for 8 weeks
  5. Administration counseling: Patient education on proper technique
  6. Monitoring plan: Follow-up schedule for healing assessment

Step Therapy and Prior Treatment Documentation

Florida Blue requires documented failure of conservative treatments before approving Oxervate. The insurer follows a staged approach that mirrors clinical best practices:

Required Prior Therapies

Treatment Minimum Duration Documentation Needed
Preservative-free artificial tears 2 weeks Pharmacy records, patient diary
Therapeutic contact lenses If clinically appropriate Trial outcomes, tolerance
Topical antibiotics For secondary infection Treatment history
Autologous serum tears If attempted Response documentation

Medical Exception Pathways

You can bypass step therapy requirements if:

  • Contraindications exist to required prior therapies
  • Previous intolerance is documented with specific reactions
  • Prior paid claims show previous failures under different insurance
  • Clinical urgency exists (stage 3 with perforation risk)

Reference Florida Statute 627.42393 when requesting step therapy exceptions, as Florida law limits certain step therapy requirements for prescription drugs.

Prior Authorization Submission Process

Step-by-Step: Fastest Path to Approval

  1. Gather documentation (Patient/Clinic): Collect all required clinical records, photos, and prior therapy documentation
  2. Complete PA request (Provider): Submit via Availity.com with complete medical necessity letter
  3. Submit supporting documents (Clinic): Include corneal photos, sensitivity testing results, prior therapy records
  4. Follow up within 3 business days (Clinic): Call 1-877-719-2583 to confirm receipt and completeness
  5. Await determination (7-14 days): Standard review timeline for non-urgent requests
  6. If approved: Coordinate with specialty pharmacy for dispensing and patient education
  7. If denied: Immediately begin internal appeal process (see Appeals section below)

Submission Options

  • Primary: Availity.com provider portal (preferred method)
  • Alternative: CoverMyMeds for electronic PA
  • Phone: 1-877-719-2583 (Florida Blue) or 800-424-4947 (Prime Therapeutics delegate)
  • Fax: Specialty pharmacy forms available through provider portal

Common Denial Reasons and Solutions

Based on analysis of Blue Cross Blue Shield denial patterns, here are the most frequent issues and targeted solutions:

Denial Reason How to Overturn
"Insufficient diagnosis documentation" Submit corneal photos, sensitivity testing results, and detailed slit-lamp findings with Mackie staging
"Inadequate prior therapy trials" Provide pharmacy records showing ≥2 weeks preservative-free tear use with documented failure
"Not medically necessary" Include peer-reviewed studies on NK progression and vision-threatening complications
"Quantity exceeds plan limits" Clarify 8-week course duration and lifetime limit per affected eye
"Missing clinical notes" Attach complete ophthalmology records with ICD-10 codes and treatment timeline

Scripts for Common Situations

Patient calling Florida Blue for PA status: "I'm calling to check the prior authorization status for Oxervate for neurotrophic keratitis, member ID [number]. Can you tell me if additional documentation is needed and provide the reference number?"

Clinic requesting peer-to-peer review: "We're requesting a peer-to-peer review for an Oxervate denial. The patient has documented stage 3 neurotrophic keratitis with failed conservative measures. Please schedule with the reviewing medical director within 72 hours per our expedited request."

Appeals Process in Florida

If Florida Blue denies your Oxervate prior authorization, you have well-defined appeal rights under Florida law:

Internal Appeal (Level 1)

  • Timeline: File within 180 days of denial notice
  • Method: Submit via Florida Blue provider portal or mail
  • Required documents: Original denial letter, additional clinical evidence, updated medical necessity letter
  • Decision timeframe: 30 days standard; 72 hours if expedited due to urgent medical need
  • Cost: No charge to member

External Review (Level 2)

After exhausting internal appeals, you can request external review through Florida's independent review process:

  • Timeline: File within 4 months of final internal denial
  • Method: Submit request to Florida Department of Financial Services
  • Phone: 1-877-MY-FL-CFO (1-877-693-5236)
  • Decision: Binding on Florida Blue if overturned
  • Success rate: External reviews overturn approximately 40-50% of denials when properly documented
From our advocates: We've seen Florida Blue approvals increase significantly when providers include side-by-side corneal photographs showing defect progression despite conservative treatment. One case involved a patient with post-surgical NK where clear visual documentation of a 4mm epithelial defect that persisted after 6 weeks of preservative-free tears led to same-day approval after initial denial.

For urgent cases involving vision-threatening complications, you can request expedited review at both levels, with decisions required within 72 hours.

Cost and Financial Assistance

Oxervate's 8-week treatment course typically costs in the low six figures, making financial assistance crucial for most patients:

Manufacturer Support

  • Dompé Patient Assistance: Oxervate.com patient resources provides copay assistance
  • Eligibility: Most commercially insured patients qualify for reduced copays (~$100/month)
  • Application: Available through ophthalmologist's office or direct enrollment

Additional Resources

  • Foundation grants: Patient Access Network Foundation and other rare disease foundations
  • State programs: Florida residents may qualify for pharmaceutical assistance through county health departments
  • Appeals success: Remember that external review success rates exceed 40% for properly documented cases

FAQ

How long does Florida Blue prior authorization take for Oxervate? Standard PA review takes 7-14 business days. Expedited review (for urgent cases) must be completed within 72 hours per Florida insurance regulations.

What if Oxervate isn't on my Florida Blue formulary? Even non-formulary drugs can be covered through medical exception requests. Submit a comprehensive PA with strong medical necessity documentation emphasizing FDA approval for neurotrophic keratitis.

Can I appeal if my previous insurance covered failed treatments outside Florida? Yes. Florida Blue must consider documented treatment failures from other states when evaluating step therapy requirements. Include pharmacy records and clinical notes from previous care.

Does step therapy apply if I'm switching from another Blue Cross plan? Transfer of care documentation can bypass step therapy. Provide records showing previous treatment attempts and their outcomes under your prior Blue Cross coverage.

What ICD-10 codes should my doctor use? Primary diagnosis should be H16.09 (other keratitis) or more specific codes like H16.001-H16.009 for unspecified keratitis by location. Include secondary codes for underlying etiology.

Can optometrists prescribe Oxervate in Florida? Currently, Florida's Board of Optometry has not approved Oxervate for optometrist prescribing. Only ophthalmologists and other MDs can prescribe this medication.

When to Get Help

If you're struggling with Florida Blue's prior authorization process or facing repeated denials, consider getting professional assistance. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each payer's specific requirements.

For additional consumer assistance, contact Florida's Division of Consumer Services at 1-877-MY-FL-CFO or submit complaints online through the Florida Department of Financial Services. State specialists can facilitate communications with Florida Blue and ensure you receive your full appeal rights.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan benefits and medical circumstances. Always consult with your healthcare provider about treatment options and contact Florida Blue directly for definitive coverage information. For personalized assistance with appeals and prior authorizations, Counterforce Health offers specialized services to help patients navigate complex insurance requirements.

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