By Counterforce Health Team in Krystexxa (pegloticase) —

The Complete Checklist to Get Krystexxa (Pegloticase) Covered by Humana in New York

Answer Box: Getting Krystexxa Covered by Humana in New York

Eligibility: Patients with chronic gout refractory to allopurinol and febuxostat who have G6PD testing completed and serum uric acid >6 mg/dL.

Fastest Path: Submit prior authorization through Humana's provider portal with medical necessity letter documenting failed conventional therapy, G6PD status, and methotrexate co-therapy plan.

First Step Today: Gather your insurance card, recent lab results (uric acid levels), and documentation of previous gout treatments. Contact your rheumatologist to initiate the prior authorization request within 2-4 weeks of planned treatment start.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking Your Request
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in New York
  11. Printable Checklist
  12. FAQ

Who Should Use This Guide

This checklist is designed for:

  • Patients with Humana Medicare Advantage or commercial plans in New York who need Krystexxa (pegloticase) for chronic refractory gout
  • Healthcare providers submitting prior authorization requests for Krystexxa
  • Caregivers and advocates helping navigate the approval process

Expected Outcome: With proper documentation following this checklist, most medically appropriate Krystexxa requests receive approval within 7-30 days. If denied, New York's external appeal process provides additional recourse with expedited 72-hour reviews for urgent cases.

Member & Plan Basics

Coverage Verification

Before starting the authorization process:

  • Confirm active Humana coverage through the member portal or by calling the number on your insurance card
  • Check your plan type: Medicare Advantage, Medicare Part D, or commercial insurance
  • Verify deductible status: High-deductible plans may require meeting your deductible before coverage begins
  • Confirm prior authorization requirement: Krystexxa requires prior authorization for all Humana plans as of 2024
Note: Humana's prior authorization denial rate for Medicare Advantage is approximately 3.5%, among the lowest of major insurers, but proper documentation is still essential.

Clinical Criteria Requirements

FDA-Approved Indication

Krystexxa is approved for chronic gout in adults refractory to conventional therapy. It is not approved for asymptomatic hyperuricemia.

Step Therapy Requirements

Required Documentation of Failure/Intolerance:

  • Allopurinol: Document maximum tolerated dose (typically 300-800 mg daily) and duration of trial (minimum 3 months)
  • Febuxostat: Document trial with appropriate dosing (40-120 mg daily) and duration
  • Clinical failure criteria: Persistent serum uric acid >6 mg/dL despite therapy OR intolerance to maximum doses

Laboratory Requirements

  • G6PD testing: Required before initiation (Krystexxa is contraindicated in G6PD deficiency)
  • Serum uric acid levels: Document levels >6 mg/dL while on conventional therapy
  • Baseline labs: Complete blood count, comprehensive metabolic panel

Methotrexate Co-therapy

Many plans now require documentation of:

  • Current methotrexate use as immunomodulator (typically 15-25 mg weekly)
  • OR clear contraindication to methotrexate with clinical justification

Coding and Billing Requirements

ICD-10 Diagnosis Codes

Use specific M1A series codes for chronic gout:

Code Description Example
M1A.0xxx Idiopathic chronic gout M1A.0711 (right ankle, without tophus)
M1A.2xxx Drug-induced chronic gout M1A.2711 (right ankle, without tophus)
M1A.3xxx Chronic gout due to renal impairment M1A.3711 (right ankle, without tophus)
M1A.9xxx Chronic gout, unspecified M1A.9711 (right ankle, without tophus)

HCPCS/J-Code

  • J2507: Pegloticase, per 1 mg
  • Standard vial: 8 mg (bill 8 units of J2507 per infusion)
  • Frequency: Every 2 weeks (26 infusions annually)

Documentation Packet Checklist

Medical Necessity Letter Components

Your rheumatologist should include:

Patient Information:

  • Full name, date of birth, Humana member ID
  • Primary diagnosis with specific ICD-10 code
  • Prescriber specialty (rheumatology preferred)

Clinical Justification:

  • Documentation of chronic gout diagnosis
  • Failed trials of allopurinol (dose, duration, reason for discontinuation)
  • Failed trials of febuxostat (dose, duration, reason for discontinuation)
  • Current serum uric acid level and trend over time
  • G6PD test result (must be negative/normal)
  • Methotrexate co-therapy plan or contraindication explanation

Treatment Plan:

  • Krystexxa dosing: 8 mg IV every 2 weeks
  • Site of care (infusion center details)
  • Monitoring plan (serum uric acid before each infusion)
  • Expected duration of therapy

Required Attachments

  • Recent clinic notes (last 3-6 months)
  • Laboratory results (uric acid trends, G6PD test)
  • Previous treatment records showing allopurinol/febuxostat trials
  • Hospital records for gout flares (if applicable)

Submission Process

Step-by-Step Submission

Step 1: Access Humana's Prior Authorization System

  • Provider portal: Humana Provider Portal
  • Phone: Provider services line on back of member ID card
  • Fax: Use current prior authorization fax number (verify with Humana)

Step 2: Complete Required Forms

  • Use Humana's current prior authorization form for specialty medications
  • Attach medical necessity letter on prescriber letterhead
  • Include all required clinical documentation

Step 3: Submit Complete Package

  • Submit all documents together to avoid delays
  • Retain confirmation numbers or submission receipts
  • Note submission date for deadline tracking

Expected Timelines

  • Standard review: 15-30 days for Medicare Advantage
  • Expedited review: 72 hours if urgent (requires clinical justification)
  • Part D medications: 7 days standard, 24 hours expedited

Specialty Pharmacy Routing

Humana's Preferred Network

CenterWell Specialty Pharmacy is Humana's primary specialty pharmacy vendor in New York.

Transfer Process

  1. Provider initiates transfer through CenterWell provider portal
  2. Complete transfer request form with all clinical documentation
  3. Coordinate with infusion site for delivery and administration
  4. Verify insurance benefits and patient responsibility

Site of Care Requirements

  • Krystexxa must be administered in a clinical setting equipped to manage anaphylaxis
  • Common sites: rheumatology offices, infusion centers, hospital outpatient departments
  • Home infusion is generally not appropriate due to safety requirements

After Submission: Tracking Your Request

Status Monitoring

  • Check status online: Humana provider portal or member portal
  • Call for updates: Use confirmation number when calling
  • Document all communications: Keep records of calls and reference numbers

What to Record

  • Submission date and confirmation number
  • Initial review timeline provided
  • Any requests for additional information
  • Final determination date and details
  • Authorization number (if approved)

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Insufficient trial of allopurinol Document maximum tolerated dose and duration Pharmacy records, clinic notes showing dose escalation
Missing G6PD test Submit lab result showing normal G6PD activity Laboratory report with normal G6PD result
No methotrexate co-therapy plan Add MTX to regimen or document contraindication Prescription for MTX or detailed contraindication note
Prescriber not rheumatologist Transfer care or obtain co-signature Rheumatology consultation or collaborative care agreement
Coding errors Use correct ICD-10 and J-code M1A.xxxx diagnosis, J2507 for billing

Appeals Process in New York

Internal Appeal with Humana

  • Timeline: 65 days from denial to file appeal
  • Process: Submit through Humana member portal or by mail
  • Required: Copy of denial letter, additional clinical documentation
  • Response time: 30 days for standard, 7 days for expedited

External Appeal through New York DFS

If Humana upholds the denial, you can request an external review through the New York Department of Financial Services.

Key Features:

  • Independent medical review by external experts
  • Expedited process: 72 hours for urgent cases
  • Cost: Maximum $25 fee (waived for financial hardship)
  • Binding decision on the insurer
Tip: New York's external appeal process has successfully overturned many specialty drug denials. Gather strong clinical evidence and consider working with a patient advocate.

Printable Checklist

Pre-Submission Checklist

  • Active Humana coverage verified
  • Rheumatologist identified as prescriber
  • G6PD test completed (normal result)
  • Allopurinol trial documented (dose, duration, outcome)
  • Febuxostat trial documented (dose, duration, outcome)
  • Current serum uric acid level >6 mg/dL
  • Methotrexate plan or contraindication documented
  • Infusion site identified and prepared
  • Medical necessity letter completed
  • All attachments gathered
  • Prior authorization form completed
  • Submission method confirmed (portal/fax)

Post-Submission Checklist

  • Confirmation number recorded
  • Calendar reminder set for status check
  • Contact information for follow-up saved
  • Appeal timeline noted (if needed)

FAQ

How long does Humana prior authorization take for Krystexxa in New York? Standard review takes 15-30 days for Medicare Advantage plans. Expedited review (72 hours) is available if your doctor certifies the delay would seriously jeopardize your health.

What if Krystexxa is non-formulary on my Humana plan? You can request a formulary exception through the same prior authorization process. Include clinical justification for why formulary alternatives are inappropriate.

Can I request an expedited appeal in New York? Yes. Both Humana internal appeals and New York DFS external appeals offer expedited timelines when your provider certifies urgent medical need.

Does step therapy apply if I failed these medications outside New York? Yes, documented failures from any location are acceptable if properly documented with clinical records and pharmacy history.

What happens if I miss the appeal deadline? Contact Humana immediately to request an exception for good cause. New York law provides some flexibility for missed deadlines due to circumstances beyond your control.

How much does Krystexxa cost if not covered? The drug cost is approximately $30,000 per infusion (every 2 weeks), totaling around $780,000 annually. Patient assistance programs may be available through the manufacturer.

When You Need Extra Help

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Krystexxa. Their platform analyzes denial letters and plan policies to craft point-by-point rebuttals that address specific coverage criteria, helping patients and providers navigate complex prior authorization requirements more effectively.

For additional support in New York:

  • Community Health Advocates: 888-614-5400 (free insurance counseling)
  • New York SHIP Program: Medicare-specific assistance
  • New York Department of Financial Services: External appeal support

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations. Coverage policies and procedures may change; verify current requirements with Humana and relevant regulatory authorities.

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