By Counterforce Health Team in Xenpozyme (olipudase alfa-rpcp) —

How to Get Xenpozyme (olipudase alfa-rpcp) Covered by Humana in New York: Forms, Appeals, and Provider Resources

Quick Answer: Getting Xenpozyme Covered by Humana in New York

To get Xenpozyme (olipudase alfa-rpcp) covered by Humana Medicare Advantage in New York: Submit prior authorization with genetic confirmation of ASMD, enzyme assay showing <10% normal activity, and SMPD1 gene test results. Your provider can submit via Humana's portal at Availity.com, fax to 502-508-9300, or call 866-421-5663. Standard review takes 30 days; expedited review 72 hours. If denied, file internal appeal within 65 days, then external appeal through New York State Department of Financial Services within 4 months.

Table of Contents

Verify Your Plan Coverage

Before starting the prior authorization process, confirm your specific Humana plan type. Xenpozyme requires prior authorization for both Medicare Advantage (Part C) and Medicare Part D coverage. Check your member ID card or log into your Humana member portal to verify coverage details.

Note: Humana's Medicare Advantage plans have a relatively low prior authorization denial rate of approximately 3.5% (2023 data), but denials often stem from incomplete documentation or missing genetic confirmation.

Prior Authorization Forms and Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
PA Required Yes, for all Humana plans Humana PA Search Tool Provider Portal
Genetic Confirmation SMPD1 gene test + enzyme assay Clinical lab results FDA Requirements
ICD-10 Codes E75.244-E75.249 (ASMD) Provider documentation Medical Records
HCPCS Code J0218 (olipudase alfa-rpcp) Billing documentation CMS Guidelines
Review Timeline 30 days standard, 72 hours expedited Humana policy Provider Manual

Required Documentation

Your healthcare provider must submit:

  1. Genetic Confirmation Package:
    • Enzyme assay showing less than 10% normal acid sphingomyelinase activity
    • SMPD1 gene test results confirming pathogenic variants
    • Clinical diagnosis of acid sphingomyelinase deficiency (ASMD)
  2. Clinical Documentation:
    • Medical necessity letter explaining why Xenpozyme is required
    • Pulmonary function tests (if respiratory symptoms present)
    • Baseline organ assessments (spleen, liver, lung function)
    • Previous treatment records showing inadequate response to supportive care
  3. Specialist Consultation:
    • Notes from metabolic specialist or geneticist
    • Treatment plan including dose escalation protocol
    • Monitoring schedule for infusion reactions

Submission Portals and Methods

Provider Submission Options

Primary Method - Availity Portal:

  • Register at Availity.com for real-time submission
  • Complete prior authorization requests online
  • Track approval status and receive notifications
  • Phone support: 1-800-523-0023

Alternative Submission Methods:

  • Fax: 502-508-9300 (prior authorization requests)
  • Phone: 866-421-5663 (Monday–Friday, 7 a.m.–7 p.m. Central time)
  • Provider Portal: provider.humana.com

Patient/Member Submission

If submitting your own prior authorization request:

  • Online: Submit Part D prior authorization through Humana member portal
  • Fax: 877-486-2621 (completed forms)
  • Phone: 800-555-CLIN (2546), Monday–Friday, 8 a.m.–8 p.m. local time
Critical: If filled without prior authorization, you may be responsible for all out-of-pocket costs, which can exceed $15,000 per month for Xenpozyme.

Specialty Pharmacy Coordination

CenterWell Specialty Pharmacy

Humana operates CenterWell Specialty Pharmacy with expedited prior authorization capabilities for rare disease medications like Xenpozyme.

Provider Setup:

  1. E-prescribe directly to CenterWell
  2. Fax prescriptions with PA documentation
  3. Access specialized rare disease support tools
  4. Coordinate with patient assistance programs

Patient Benefits:

  • Dedicated rare disease pharmacists
  • Insurance navigation support
  • Home delivery with cold-chain management
  • 24/7 clinical support line

Support Lines and Provider Contacts

Key Contact Numbers

Service Phone Number Hours Use For
Medicare Advantage PA 866-488-5995 (providers) Business hours PA submissions, status
Member Services 866-773-5959 Business hours Member PA requests
Medical Customer Service 800-457-4708 Mon-Fri, 8am-8pm Benefits, eligibility
Provider Relations 800-626-2741 Mon-Fri, 8am-5pm CT Contract, payment issues
Clinical Pharmacy Review Via provider portal Business hours Complex PA cases
Tip: Always obtain a reference number when calling and document the representative's name and date for your records.

Appeals Process in New York

Step-by-Step Appeals Pathway

1. Internal Appeal (Required First Step)

  • Timeline: File within 65 days of denial notice
  • Method: Submit written appeal to address on denial letter
  • Documentation: Include denial notice, medical records, physician letter
  • Review Time: 30 days for standard, 72 hours for expedited

2. External Appeal Through New York State

  • Timeline: File within 4 months of final adverse determination
  • Form: New York State External Appeal Form
  • Submit To: NY Department of Financial Services, 99 Washington Avenue, Box 177, Albany, NY 12210
  • Fax: 800-332-2729
  • Fee: $25 maximum (waived for financial hardship)

Required Documents for External Appeal

  1. Completed external appeal application
  2. Physician attestation form (signed by prescribing specialist)
  3. Original denial notice and internal appeal decision
  4. Medical records supporting medical necessity
  5. Signed consent to release medical records
Expedited Appeals: For urgent cases where delay threatens health, New York processes appeals within 72 hours (24 hours for non-formulary drugs).

Consumer Assistance Resources

Free Help Available in New York

Community Health Advocates (CHA)

  • Helpline: 888-614-5400
  • Services: Free insurance appeal assistance for all New Yorkers
  • Expertise: Rare disease coverage denials and complex appeals
  • Website: communityhealthadvocates.org

When you call CHA, have ready:

  • Your insurance card and member ID
  • Denial notice and explanation of benefits
  • Medical records and physician letters
  • Timeline of when you filed previous appeals

State Regulatory Support

New York Department of Financial Services

New York's external appeal system has strong consumer protections—decisions are binding on insurers, and successful appeals result in coverage plus refund of filing fees.

Clinician Corner: Medical Necessity Documentation

Healthcare providers should include these elements in medical necessity letters for Xenpozyme:

Essential Components:

  • Confirmed ASMD diagnosis with genetic testing results
  • Clinical manifestations (organomegaly, pulmonary involvement, hematologic abnormalities)
  • Baseline assessments of affected organs
  • Documentation that supportive care is insufficient
  • Treatment goals and monitoring plan
  • Dose escalation protocol to minimize infusion reactions

Key Clinical References:

  • FDA prescribing information for Xenpozyme
  • Clinical trial data from pivotal studies
  • Published treatment guidelines for ASMD management

Counterforce Health specializes in helping providers create targeted, evidence-backed appeals for rare disease medications. Their platform analyzes denial letters and generates point-by-point rebuttals aligned with each payer's specific policies, significantly improving approval rates for complex cases like Xenpozyme.

FAQ

How long does Humana prior authorization take for Xenpozyme in New York? Standard review takes 30 days. Expedited review (when delay threatens health) takes 72 hours. Your provider can request expedited review when submitting the initial PA.

What if Xenpozyme is non-formulary on my Humana plan? Request a formulary exception by demonstrating medical necessity. Since Xenpozyme is the only FDA-approved treatment for ASMD, formulary exceptions are often approved with proper documentation.

Can I appeal a Humana denial myself in New York? Yes. You can file internal appeals directly with Humana and external appeals with New York State DFS. However, provider involvement typically strengthens appeals with clinical documentation.

Does step therapy apply to Xenpozyme? Traditional step therapy doesn't apply since Xenpozyme is the only FDA-approved treatment for ASMD. However, Humana may require documentation of failed supportive treatments.

What happens if I miss the appeal deadline? Missing Humana's 65-day internal appeal deadline eliminates your right to external appeal. However, if you have good cause for the delay, contact Community Health Advocates at 888-614-5400 for assistance.

How much does Xenpozyme cost without insurance? Wholesale acquisition cost ranges from $1,515 per 4mg vial to $7,576 per 20mg vial (January 2025 pricing). Monthly costs can exceed $15,000 depending on patient weight and dosing.

From Our Advocates

We've seen cases where initial Xenpozyme denials were overturned simply by resubmitting with complete genetic testing documentation. One New York patient received approval on internal appeal after their specialist included baseline pulmonary function tests and a detailed monitoring plan. The key is ensuring your provider submits all required ASMD diagnostic criteria upfront—genetic confirmation, enzyme levels, and clinical manifestations—rather than piecemeal documentation.

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 specific coverage decisions. For personalized assistance with insurance appeals in New York, contact Community Health Advocates at 888-614-5400 or the New York State Department of Financial Services consumer hotline at 1-800-400-8882.

Need help turning your denial into an approval? Counterforce Health helps patients, clinicians, and specialty pharmacies create evidence-backed appeals that align with each insurer's specific policies, improving approval rates for complex rare disease medications like Xenpozyme.

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