By Counterforce Health Team in Therakos CELLEX (photopheresis system) —

Cigna's Coverage Criteria for Therakos CELLEX Photopheresis in Michigan: What Counts as "Medically Necessary"?

Answer Box: Getting Therakos CELLEX Covered by Cigna in Michigan

Cigna requires prior authorization for Therakos CELLEX photopheresis system for CTCL and GVHD treatments. To qualify, you need documented steroid-refractory or progressive disease after standard therapies. Submit via CoverMyMeds ePA or Cigna's precertification portal with diagnosis, prior therapy failures, and specialist oversight. If denied, Michigan's DIFS external review provides final appeal within 127 days. Start today: Contact your transplant/hematology specialist to document steroid-refractory status and submit PA with clinical notes showing failed conventional therapies.

Table of Contents

  1. Cigna's Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy & Prior Authorization
  4. Frequency Limits & Treatment Schedule
  5. Required Documentation
  6. Specialty Pharmacy & Site of Care
  7. Evidence to Support Approval
  8. Sample Medical Necessity Narrative
  9. Appeals Process in Michigan
  10. Common Denial Reasons & Solutions
  11. FAQ

Policy Overview

Cigna covers the Therakos CELLEX photopheresis system as a medical benefit procedure (CPT 36522) rather than a pharmacy benefit. This means prior authorization flows through Cigna's medical management team, not Express Scripts or Accredo specialty pharmacy.

Plan Types Covered:

  • Commercial PPO/HMO plans
  • Medicare Advantage plans
  • Self-funded employer plans (may have variations)

The Therakos CELLEX system is FDA-cleared for extracorporeal photopheresis in cutaneous T-cell lymphoma and steroid-refractory graft-versus-host disease. Cigna's coverage follows FDA labeling and established clinical guidelines.

Note: Unlike many specialty drugs that were removed from Cigna's prior authorization list in 2024-2025, ECP procedures remain subject to precertification due to their complexity and cost.

Medical Necessity Requirements

Cigna considers Therakos CELLEX medically necessary for specific indications when standard therapies have failed or are inappropriate:

Covered Indications

Cutaneous T-Cell Lymphoma (CTCL):

  • Stage III-IV disease as first-line systemic therapy
  • Early-stage (I-II) disease that's progressive and refractory to skin-directed therapies (topical steroids, PUVA, radiation)
  • Erythrodermic mycosis fungoides or Sézary syndrome

Graft-Versus-Host Disease:

  • Acute GVHD: Steroid-refractory disease (failed ≥3-7 days of high-dose steroids)
  • Chronic GVHD: Failed ≥1 systemic immunosuppressive therapy beyond steroids

Based on Cigna's GVHD medication policies, "steroid-refractory" typically means persistent or worsening symptoms despite adequate corticosteroid therapy (prednisone ≥1-2 mg/kg/day or equivalent).

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Required for all ECP Submit before treatment Cigna Precert
FDA-Approved Indication CTCL or steroid-refractory GVHD Diagnosis codes, staging FDA Labeling
Failed Standard Therapy Documented treatment failures Medication history, response notes Cigna GVHD Policy
Specialist Oversight Hematology/oncology or transplant Provider credentials Cigna Precert Guidelines

Step Therapy & Prior Authorization

Required Prior Therapies

For CTCL:

  • Topical corticosteroids
  • PUVA or other phototherapy
  • Topical chemotherapy (mechlorethamine, carmustine)
  • Radiation therapy (for localized disease)

For GVHD:

  • High-dose systemic corticosteroids (prednisone ≥1 mg/kg/day)
  • At least one additional systemic agent: tacrolimus, cyclosporine, mycophenolate, sirolimus, or newer agents like ruxolitinib

Medical Exceptions

Cigna allows step therapy exceptions when:

  • Prior therapies are contraindicated due to allergies or comorbidities
  • Patient has documented intolerance to required medications
  • Clinical urgency requires immediate ECP (severe, rapidly progressive disease)

Frequency Limits & Treatment Schedule

Standard ECP protocols for Therakos CELLEX follow established clinical patterns:

Initial Treatment:

  • CTCL: 2 consecutive days every 4 weeks for minimum 7 cycles (6 months)
  • GVHD: 2 consecutive days weekly, then taper based on response

Response Assessment:

  • Evaluate at 3 months (4th cycle) for CTCL
  • Adequate response (≥25% improvement): Continue or reduce to every 5 weeks
  • Inadequate response: May escalate to every 2 weeks for up to 3 months

Duration Limits:

Required Documentation

Core Clinical Documentation

Diagnosis and Staging:

  • Pathology reports confirming CTCL subtype and stage
  • For GVHD: transplant date, donor type, organ involvement, grading per established criteria

Treatment History:

  • Complete medication list with dates, doses, and response
  • Objective measures of treatment failure (lab values, imaging, clinical scores)
  • Documentation of adverse effects or contraindications

Baseline Assessments:

  • CTCL: Skin involvement percentage, lymph node assessment, blood involvement
  • GVHD: Organ-specific measures (skin score, liver function, GI symptoms, pulmonary function)

Specialist Requirements

Treatment must be ordered and monitored by:

Specialty Pharmacy & Site of Care

ECP is performed as an outpatient procedure, not dispensed through specialty pharmacy. Key considerations:

Approved Sites:

  • Hospital-based outpatient departments
  • Accredited infusion centers
  • Facilities with FDA-approved Therakos CELLEX systems

Routing Rules:

  • Prior authorization through Cigna medical management
  • Not subject to Express Scripts specialty pharmacy requirements
  • May require network facility verification

Evidence to Support Approval

Clinical Guidelines

NCCN Guidelines: NCCN Primary Cutaneous Lymphomas lists ECP as Category 2A therapy for advanced CTCL.

Professional Consensus: Transplant societies recognize ECP for steroid-refractory GVHD based on clinical trial evidence and real-world outcomes.

Key Citations for Appeals

  1. FDA Approval: Therakos CELLEX cleared for CTCL and steroid-refractory GVHD
  2. CMS Coverage: Medicare recognizes ECP as reasonable and necessary for covered indications
  3. Clinical Evidence: Multiple randomized trials showing efficacy in refractory disease

Sample Medical Necessity Narrative

Clinician Corner: Medical Necessity Letter Template

"Patient has [stage/grade] [CTCL/acute GVHD/chronic GVHD] diagnosed on [date] with [organ involvement]. Despite adequate trial of [list specific prior therapies with dates and doses], patient demonstrates [objective measures of treatment failure/progression]. Current symptoms include [specific clinical findings]. Standard therapies are [contraindicated/failed/inadequately effective] due to [specific reasons]. ECP with Therakos CELLEX is indicated per NCCN guidelines/transplant consensus for steroid-refractory disease. Proposed treatment schedule: [frequency] for [duration] with response assessment via [objective measures]. Treatment will be performed at [accredited facility] under specialist supervision."

Appeals Process in Michigan

Internal Appeals (First Step)

Timeline: Cigna must respond within 15 days for standard appeals, 72 hours for expedited How to Submit:

  • Online: Cigna member portal
  • Phone: (800) 882-4462
  • Mail: Include denial letter and additional clinical evidence

Michigan External Review

If Cigna's internal appeal is denied, Michigan law provides external review through the Department of Insurance and Financial Services (DIFS).

Key Details:

  • Deadline: 127 days after final internal denial
  • Process: DIFS External Review Request form
  • Timeline: 60 days maximum (often faster)
  • Expedited: 72 hours for urgent cases with physician letter

Contact DIFS:

From Our Advocates: "We've seen several Michigan patients successfully overturn Cigna ECP denials through DIFS external review. The key was providing comprehensive documentation of steroid-refractory status and specialist letters confirming medical necessity. Most decisions came back within 30-45 days, well under the 60-day maximum."

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
"Not medically necessary" Emphasize steroid-refractory status Medication records, response notes
"Experimental/investigational" Cite FDA approval and NCCN guidelines FDA labeling, NCCN excerpt
"Insufficient prior therapy" Document all failed treatments Complete medication history
"Frequency exceeds policy" Justify clinical need for intensive schedule Specialist letter, disease severity
"Non-network facility" Request network exception Facility accreditation, geographic access

FAQ

How long does Cigna prior authorization take in Michigan? Standard PA decisions within 15 days; expedited within 72 hours. Michigan requires FIS 2288 form for prescription-related requests.

What if Therakos CELLEX is considered experimental? Request medical exception citing FDA approval and established clinical use. ECP is covered by Medicare and most commercial plans for appropriate indications.

Can I appeal if I live in Michigan but have an out-of-state Cigna plan? Yes, Michigan residents can use DIFS external review regardless of where the plan is domiciled, as long as care is received in Michigan.

Does step therapy apply if I failed similar treatments in another state? Yes, document all prior therapies regardless of location. Cigna accepts treatment history from any qualified provider.

How much does ECP cost without insurance? Hospital-based ECP typically costs $3,000-5,000 per cycle. Therakos offers patient support programs for eligible patients.

What's the difference between acute and chronic GVHD coverage? Both are covered if steroid-refractory, but acute GVHD requires documented failure of high-dose steroids, while chronic GVHD requires failure of at least one systemic therapy beyond steroids.

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 evidence-backed appeals that address each payer's specific requirements. For complex treatments like Therakos CELLEX photopheresis, we help identify the exact clinical documentation needed to demonstrate medical necessity and overcome common denial reasons.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For assistance with insurance appeals in Michigan, contact the Michigan Department of Insurance and Financial Services at (877) 999-6442.

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