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

Getting Therakos CELLEX Photopheresis Covered by Humana in New York: Prior Authorization Guide and Appeal Scripts

Answer Box: Getting Started

Humana requires prior authorization for Therakos CELLEX photopheresis in New York for CTCL and steroid-refractory GVHD. Submit documentation through Humana's provider portal showing failed prior therapies and specialist oversight. If denied, you have 65 days to appeal internally, then 45 days for New York's external review. First step: Contact your specialist to gather medical necessity documentation and submit the PA request immediately.

Table of Contents

  1. What Drives Coverage Decisions
  2. Benefit Investigation: What to Ask
  3. Prior Authorization Requirements
  4. Cost and Financial Assistance
  5. Appeals Process in New York
  6. Common Denial Reasons and Solutions
  7. Step-by-Step Approval Guide
  8. Scripts for Key Conversations
  9. FAQ

What Drives Coverage Decisions

Therakos CELLEX photopheresis falls under Medicare Part B as a medical procedure, not a pharmacy benefit. This means it's covered through your Humana Medicare Advantage medical benefits with standard 20% coinsurance after your annual deductible ($257 in 2025).

Coverage Criteria at a Glance:

Requirement What It Means Where to Find It
Prior Authorization Required for all photopheresis Humana PA List
Covered Indications CTCL, steroid-refractory GVHD Medicare NCD 110.4
Site of Care Hospital outpatient infusion centers only Humana medical policy
Frequency Limits Up to 2 consecutive days every 4 weeks Clinical documentation required
Specialist Oversight Oncologist or transplant specialist required Medical necessity letter

The key factor driving approval is demonstrating that photopheresis meets Medicare's definition of medical necessity for your specific condition.

Benefit Investigation: What to Ask

Before starting treatment, gather this essential information from Humana:

Questions for Humana Member Services (1-800-457-4708):

  • Is prior authorization required for CPT code 36522 (photopheresis)?
  • What's my annual deductible status and coinsurance rate?
  • Which treatment facilities are in-network for photopheresis?
  • What documentation is needed for the PA request?

Information to Record:

  • Your member ID and group number
  • Prior authorization reference number (once submitted)
  • Names of representatives you speak with
  • All denial reasons in writing
Tip: Request all benefit information in writing through Humana's member portal to create a paper trail for potential appeals.

Prior Authorization Requirements

Humana requires comprehensive documentation for photopheresis approval:

Required Documentation:

  • Definitive diagnosis with ICD-10 codes (CTCL or GVHD)
  • Prior therapy failures with specific medications, doses, and durations
  • Medical necessity letter from treating specialist
  • Treatment plan including frequency and duration
  • Facility verification that treatment site is in-network

Medical Necessity Letter Checklist:

  • Patient's diagnosis and staging (for CTCL)
  • Previous treatments attempted and outcomes
  • Clinical rationale for photopheresis
  • Expected treatment frequency and monitoring plan
  • Reference to published guidelines or studies
  • Physician's credentials and specialty certification
Note: For steroid-refractory GVHD, document specific steroid therapies tried, dosages, duration, and reasons for discontinuation or failure.

Cost and Financial Assistance

Medicare Cost-Sharing:

  • Annual deductible: $257 (2025)
  • Coinsurance: 20% of Medicare-approved amount
  • No out-of-pocket maximum under traditional Medicare

Financial Support Options:

Since Medicare patients cannot use manufacturer copay cards due to federal anti-kickback regulations, alternative assistance includes:

  • Foundation Grants: Apply to the Leukemia & Lymphoma Society or CancerCare for copay assistance
  • Hospital Charity Care: Ask your treatment facility about financial assistance programs
  • Mallinckrodt Patient Support: Contact the manufacturer for navigation resources (not direct copay help)

Actionable Steps:

  1. Get a cost estimate from your treatment facility
  2. Apply for relevant foundation grants based on your diagnosis
  3. Ask about hospital payment plans or charity care eligibility
  4. Consider supplemental insurance for future coverage gaps

Appeals Process in New York

New York offers robust appeal rights for Humana Medicare Advantage denials:

Internal Appeal (Level 1):

  • Deadline: 65 days from denial letter
  • Timeline: 30 days for standard, 72 hours for expedited
  • How to File: Humana member portal, phone, or mail
  • Required: All supporting clinical documentation

External Appeal (Level 2):

  • When: After final adverse determination from Humana
  • Deadline: 45 days from final denial
  • Authority: New York State Department of Financial Services
  • Cost: Free to members
  • Timeline: 30 days standard, 3 days expedited

New York External Appeal Process:

  1. Complete the state external appeal application
  2. Attach all denial letters and clinical documentation
  3. Include peer-reviewed literature supporting photopheresis
  4. Submit within 45 days to maintain appeal rights
From Our Advocates: We've seen external appeals succeed when patients include specific clinical literature showing photopheresis response rates (60-80% for CTCL, ~60% for GVHD) along with documentation of failed prior therapies. The key is matching your clinical situation to published evidence.

Contact Information:

  • Community Health Advocates: 888-614-5400 (free assistance with appeals)
  • NY DFS External Appeals: Submit through DFS online portal

Common Denial Reasons and Solutions

Denial Reason How to Overturn Documentation Needed
"Not medically necessary" Provide clinical literature and specialist letter Peer-reviewed studies, treatment guidelines
"Experimental/investigational" Reference Medicare NCD 110.4 coverage Medicare coverage determination
"Prior therapies not documented" Submit detailed treatment history Pharmacy records, physician notes
"Frequency exceeds policy" Justify medical necessity for schedule Clinical rationale from specialist
"Site of care not approved" Verify in-network status Facility contracts with Humana

Step-by-Step Approval Guide

Phase 1: Preparation (Week 1)

  1. Gather Records: Collect all prior treatment documentation, lab results, and imaging
  2. Verify Benefits: Call Humana to confirm PA requirements and in-network facilities
  3. Specialist Letter: Have your oncologist or transplant specialist prepare medical necessity letter

Phase 2: Submission (Week 2) 4. Submit PA Request: Use Humana's provider portal with complete documentation 5. Follow Up: Confirm receipt and get reference number for tracking 6. Peer Review: Request peer-to-peer review if initial denial occurs

Phase 3: Appeals (If Needed) 7. Internal Appeal: Submit within 65 days with additional clinical evidence 8. External Review: File with New York State within 45 days of final denial

Scripts for Key Conversations

Patient Script for Humana Member Services: "I need prior authorization for extracorporeal photopheresis (CPT code 36522) for [CTCL/steroid-refractory GVHD]. Can you tell me what documentation is required and which treatment facilities are in-network? I'd also like to know my current deductible status and coinsurance rate for this procedure."

Clinic Script for Peer-to-Peer Review: "We're requesting a peer-to-peer review for [patient name] regarding photopheresis denial. Our specialist can discuss the clinical rationale, prior therapy failures, and published evidence supporting this treatment. When can we schedule the review?"

Appeal Letter Template Opening: "We are appealing the denial of extracorporeal photopheresis for [patient name] based on medical necessity. The patient has [specific diagnosis] with documented failure of [list prior therapies]. Published literature demonstrates response rates of [cite specific studies] for this indication."

FAQ

How long does Humana prior authorization take in New York? Standard PA decisions are made within 14 days. Expedited requests (for urgent needs) are decided within 72 hours.

What if photopheresis is denied as experimental? Reference Medicare NCD 110.4, which specifically covers photopheresis for CTCL and certain other conditions. This is not experimental under Medicare guidelines.

Can I get expedited appeals in New York? Yes, if your health is at serious risk. New York expedited external appeals are decided within 3 days (or 24 hours for urgent drug denials).

Does step therapy apply to photopheresis? Humana may require documentation of failed prior therapies, but this varies by indication. CTCL typically requires failed topical treatments; GVHD requires steroid failure.

What happens if my appeal is denied? After internal appeals are exhausted, you can request external review through New York State. The external reviewer's decision is binding on Humana.

Are there alternatives if photopheresis is denied? For GVHD: ruxolitinib or belumosudil. For CTCL: systemic therapies or topical regimens per NCCN guidelines. Discuss with your specialist.

How Counterforce Health Can Help

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform identifies the specific denial basis and drafts point-by-point responses aligned with each payer's own rules, pulling the right clinical evidence and procedural requirements to maximize approval chances.

For complex treatments like photopheresis, having expert support can make the difference between approval and denial. Counterforce Health helps patients and clinicians navigate the prior authorization maze with payer-specific workflows and deadline tracking.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with Humana and consult with your healthcare provider about treatment decisions. For personalized assistance with New York insurance appeals, contact Community Health Advocates at 888-614-5400.

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