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

How to Get Therakos CELLEX Photopheresis Covered by Humana in Ohio: Complete Prior Authorization Guide

Answer Box: Getting Started

Therakos CELLEX photopheresis requires prior authorization from Humana in Ohio for covered conditions like steroid-refractory GVHD and CTCL. Your fastest path to approval: 1) Confirm your specialist can document steroid failure or CTCL staging, 2) Submit comprehensive PA request through Humana's provider portal with medical necessity letter, and 3) If denied, file internal appeal within 65 days. Standard PA decisions take 14 days; expedited requests 72 hours. Start by calling Humana at 1-800-281-6918 to verify your plan's specific coverage requirements.

Table of Contents

Plan Types & Coverage Implications

Humana offers several plan types in Ohio, each with different coverage rules for photopheresis:

Medicare Advantage Plans: Most common in Ohio, these plans follow Medicare guidelines but may have additional prior authorization requirements. Photopheresis is covered under Medicare Part B as a medical service (CPT 36522).

Medicaid Plans: Humana Healthy Horizons members receive prescription coverage through Gainwell, Ohio's Single Pharmacy Benefit Manager. Prior authorization requirements are managed through Ohio Medicaid's system.

Commercial Plans: Employer-sponsored plans may have varying coverage policies. Check your specific Evidence of Coverage document for photopheresis coverage details.

Note: Self-funded employer plans follow federal ERISA law, not Ohio state insurance regulations, which affects your appeal rights.

Formulary Status & Approval Criteria

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all photopheresis Humana PA Search Tool Provider Portal
Covered Conditions CTCL, steroid-refractory GVHD Medical policy documents Plan materials
Site of Care Hospital outpatient centers only Coverage determination PA approval
Treatment Frequency Up to 2 consecutive days every 4 weeks Utilization management Medical necessity
Specialist Required Oncologist or transplant specialist Provider network Humana directory

Therakos CELLEX photopheresis is covered by Humana for specific medical conditions when criteria are met. The treatment must be deemed medically necessary and performed at approved facilities.

Covered Indications:

  • Cutaneous T-cell lymphoma (CTCL)
  • Steroid-refractory chronic graft-versus-host disease (GVHD)
  • Acute cardiac rejection (rare)

Non-Covered Uses: Off-label indications not supported by medical literature or FDA approval typically require appeals with extensive clinical evidence.

Prior Authorization Requirements

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic): Call Humana at 1-800-281-6918 with your member ID to confirm photopheresis coverage under your specific plan.
  2. Gather Documentation (Clinic): Collect diagnosis codes, prior treatment records, and specialist consultation notes. Timeline: 1-2 business days.
  3. Medical Necessity Letter (Specialist): Oncologist or transplant specialist drafts comprehensive letter with clinical rationale. Submit within 3-5 business days.
  4. Submit PA Request (Clinic): Use Humana's provider portal or Availity Essentials. Standard processing: 14 days.
  5. Follow Up (Patient): Contact Humana if no decision within timeline. Request expedited review if health at risk (72-hour decision).
  6. Schedule Treatment (Upon Approval): Coordinate with approved facility for photopheresis sessions.
  7. Monitor Authorization (Ongoing): Track approval periods and reauthorization requirements.

Required Documentation

Clinical Documentation Must Include:

  • Definitive diagnosis with ICD-10 codes
  • Complete medical history and physical exam
  • Pathology reports confirming CTCL or transplant records for GVHD
  • Current medication list and allergies
  • Recent laboratory values and imaging studies

For Steroid-Refractory GVHD:

  • Documentation of steroid failure defined by:
    • Disease progression within 3-5 days of high-dose steroids (≥2 mg/kg/day)
    • No improvement within 5-7 days of steroid therapy
    • Incomplete response after 28+ days of treatment
  • Specific steroid regimen details (drug, dose, duration)
  • Objective measures of treatment failure

For CTCL:

  • Staging studies and disease extent
  • Previous topical and systemic therapies attempted
  • Response to prior treatments with objective measures

Clinician Corner: Medical Necessity Letter Checklist

Your specialist's letter should address:

✓ Patient's specific diagnosis with staging (CTCL) or transplant details (GVHD)
✓ Prior treatments attempted with specific medications, doses, durations, and outcomes
✓ Clinical rationale for photopheresis based on published guidelines
✓ Expected treatment plan including frequency and monitoring approach
✓ Physician credentials and specialty board certification
✓ Literature citations supporting photopheresis for the patient's condition

Include references to NCCN guidelines for CTCL or transplant society recommendations for GVHD management.

Specialty Treatment Setup

Photopheresis requires coordination between multiple healthcare providers and Humana's network.

Approved Treatment Sites: Humana requires photopheresis be performed at hospital outpatient infusion centers only. Verify your facility is in-network before scheduling.

Specialist Requirements: Treatment must be overseen by:

  • Board-certified oncologist (for CTCL)
  • Transplant specialist or hematologist (for GVHD)
  • Facility with photopheresis equipment and trained staff

Coordination Steps:

  1. Confirm specialist is in Humana's network
  2. Verify treatment facility participates with Humana
  3. Schedule consultation before PA submission
  4. Coordinate PA timing with treatment scheduling

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex treatments like photopheresis. Their platform identifies denial reasons and drafts point-by-point rebuttals aligned to plan policies, helping patients and providers navigate the approval process more effectively.

Submission Process

Portal Access and Forms

Provider Submission: Use Humana's provider portal or Availity Essentials for PA requests. For Availity registration issues, call 800-AVAILITY (282-4548), Monday–Friday, 8 a.m.–8 p.m. Eastern.

Required Information:

  • Member ID and demographics
  • Requesting provider NPI and contact information
  • CPT code 36522 (extracorporeal photopheresis)
  • ICD-10 diagnosis codes
  • Treatment frequency and duration requested
  • Supporting clinical documentation

Processing Timelines:

  • Standard requests: 14 calendar days
  • Expedited requests: 72 hours (when health at serious risk)
  • Incomplete submissions may extend timelines
Tip: Submit complete documentation initially to avoid delays from requests for additional information.

Appeals in Ohio

If Humana denies your photopheresis request, Ohio provides robust appeal rights with specific timelines and processes.

Internal Appeals with Humana

Timeline: 65 days from denial notice to file internal appeal

Submission Methods:

  • Online through member portal
  • Mail to address on denial letter
  • Fax (verify current number with member services)
  • Phone: 1-800-281-6918

Required Documentation:

  • Original denial letter
  • Additional clinical evidence
  • Updated medical necessity letter
  • Any new supporting studies or guidelines

External Review in Ohio

Ohio law provides independent external review after exhausting internal appeals.

Eligibility: Available 180 days from final internal denial

Process:

  1. Request external review through your health plan
  2. Plan notifies Ohio Department of Insurance
  3. Independent Review Organization (IRO) assigned
  4. Medical experts review case independently

Timelines:

  • Standard external review: 30 days
  • Expedited review: 72 hours (serious health risk)
  • IRO decision is binding on Humana

Ohio Resources:

From Our Advocates: We've seen external reviews succeed when patients include updated clinical evidence that wasn't available during the initial PA request. One composite case involved a CTCL patient whose external review was approved after including new staging studies showing disease progression, even though the initial request was denied for insufficient documentation.

Cost Considerations

Insurance Coverage

Photopheresis is typically covered under medical benefits (not pharmacy) when prior authorized. Your costs depend on:

  • Deductible: Medical deductible applies before coverage begins
  • Coinsurance: Usually 20% for Medicare Advantage plans
  • Copayment: May apply for outpatient hospital services
  • Out-of-pocket maximum: Annual limit protects against high costs

Financial Assistance Options

Manufacturer Support: Contact Mallinckrodt (Therakos) at their patient support program for potential assistance with copayments and deductibles.

Hospital Financial Aid: Many Ohio hospitals offer charity care or payment plans for qualifying patients.

State Resources: Ohio has programs for residents facing medical financial hardship. Contact Ohio Department of Health for information.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
Insufficient steroid failure documentation Provide detailed steroid trial records Specific medications, doses, durations, objective failure measures
Non-covered indication Appeal with clinical literature Published studies supporting use for patient's condition
Frequency exceeds policy limits Medical necessity for increased frequency Specialist letter explaining why standard frequency insufficient
Non-preferred facility Request facility exception Demonstrate medical necessity for specific site
Lack of specialist oversight Add appropriate specialist to team Board-certified oncologist or transplant specialist consultation

When appealing denials, Counterforce Health helps identify the specific denial basis and crafts targeted rebuttals using the right clinical evidence and plan-specific language to maximize approval chances.

FAQ

How long does Humana prior authorization take in Ohio?
Standard PA decisions take 14 calendar days. Expedited requests are decided within 72 hours when health is at serious risk.

What if photopheresis is non-formulary on my plan?
Photopheresis is a medical procedure (CPT 36522), not a pharmacy benefit. It's covered under medical benefits when criteria are met, regardless of formulary status.

Can I request expedited review?
Yes, if delay would seriously jeopardize your health or ability to regain maximum function. Your physician must document the urgency.

Does step therapy apply if I failed treatments outside Ohio?
Prior treatment failures from any location count toward meeting step therapy requirements. Provide complete documentation of all prior therapies.

What happens if my appeal is denied?
After internal appeals, you can request external review through the Ohio Department of Insurance within 180 days of final denial.

Who can perform photopheresis in Ohio?
Treatment must occur at hospital outpatient infusion centers with board-certified specialists (oncologist for CTCL, transplant specialist for GVHD).

Are there alternatives if photopheresis isn't approved?
For GVHD: ruxolitinib, belumosudil. For CTCL: systemic therapies per NCCN guidelines. Discuss options with your specialist.

How do I find in-network providers?
Use Humana's provider directory online or call member services at 1-800-281-6918 to verify network participation.

Sources & Further Reading

This guide provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan terms and medical circumstances. Consult your healthcare provider for medical guidance and contact Humana directly for definitive coverage information. For additional help with Ohio insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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