By Counterforce Health Team in Krystexxa (pegloticase) —

How to Get Krystexxa (Pegloticase) Covered by Aetna CVS Health in Pennsylvania: Complete Coding, Appeals & Timeline Guide

Answer Box: Your Fastest Path to Krystexxa Coverage

To get Krystexxa (pegloticase) covered by Aetna CVS Health in Pennsylvania: Submit a prior authorization with ICD-10 code M1A.*** (chronic gout), HCPCS J2507 (8 units per dose), documented failure of allopurinol and febuxostat, G6PD test results, and methotrexate co-therapy plan. If denied, you have 180 days to appeal internally, then can request Pennsylvania's external review within 4 months. Start today: Contact your rheumatologist to gather prior therapy documentation and order G6PD screening.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Chronic Gout
  3. Product Coding: HCPCS J2507, NDC, and Units
  4. Clean Prior Authorization Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with Aetna Resources
  7. Quick Pre-Submission Audit
  8. Appeals Process in Pennsylvania
  9. Common Denial Reasons & Solutions
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Krystexxa (pegloticase) is administered as an IV infusion every two weeks, placing it squarely under medical benefit coverage rather than pharmacy benefit. This means:

  • HCPCS J-code billing (not NDC-based pharmacy claims)
  • Prior authorization through medical management, not pharmacy
  • Site of service must be appropriate for IV infusion (office, hospital outpatient)
  • Infusion codes (CPT 96365, 96366) bill separately from the drug

Aetna CVS Health processes Krystexxa through their specialty pharmacy division, but the coverage determination follows medical benefit rules. Understanding this distinction prevents the common mistake of submitting pharmacy prior authorizations for what should be medical benefit requests.

ICD-10 Mapping for Chronic Gout

The foundation of any successful Krystexxa prior authorization is precise ICD-10 coding that supports medical necessity. Use the M1A.* series for chronic gout:

Primary Code Options

ICD-10 Code Description When to Use Documentation Keywords
M1A.0*** Idiopathic chronic gout Primary/unknown cause "chronic gout," "recurrent flares," "persistent hyperuricemia"
M1A.3*** Chronic gout due to renal impairment CKD present "renal impairment," "decreased uric acid clearance"
M1A.4*** Other secondary chronic gout Drug-induced, lead poisoning "secondary to," "medication-induced"
M1A.9*** Chronic gout, unspecified When cause unclear "chronic gouty arthritis," "tophaceous gout"

Seventh Character Specificity

Complete your M1A code with the seventh character specifying joint involvement:

  • 0 = Multiple sites
  • 1 = Shoulder
  • 2 = Elbow
  • 3 = Wrist
  • 4 = Hand
  • 5 = Hip
  • 6 = Knee
  • 7 = Ankle and foot
  • 8 = Vertebrae
  • 9 = Multiple sites

Example: M1A.9XX1 = Chronic gout, unspecified, with tophus (tophi)

Tip: Always document presence or absence of tophi, as this affects the sixth character and strengthens the case for refractory disease requiring advanced therapy.

Product Coding: HCPCS J2507, NDC, and Units

Krystexxa billing centers on HCPCS code J2507 (pegloticase, per 1 mg). Here's the essential math and coding requirements:

Core Billing Information

  • HCPCS: J2507 (pegloticase, 1 mg)
  • Standard dose: 8 mg IV every 2 weeks
  • Units per dose: 8 (since each unit = 1 mg)
  • NDC: 75987-0080-10 (8 mg single-use vial)
  • Typical reimbursement: ~$3,546 per administration (varies by contract)

Required Modifiers

  • JW modifier: Use when drug is discarded/wasted
  • JZ modifier: Use when no drug wastage occurs
  • Site of service: Code 11 (office) or 22 (hospital outpatient)

Infusion Coding

Bill infusion administration separately:

  • CPT 96365: IV infusion, first hour
  • CPT 96366: Each additional hour (Krystexxa requires ≥120 minutes)
Note: Krystexxa requires premedication with antihistamines and corticosteroids. Bill these separately with appropriate CPT/HCPCS codes per Aetna's policy.

Clean Prior Authorization Anatomy

A successful Aetna prior authorization for Krystexxa must include these core elements:

Required Clinical Documentation

  1. Diagnosis confirmation with specific ICD-10 code
  2. Prior therapy failures: Documented inadequate response or intolerance to allopurinol AND febuxostat (minimum 3 months each at maximum tolerated doses)
  3. G6PD screening results (must be normal/negative)
  4. Methotrexate co-therapy plan or documented contraindication
  5. Baseline serum uric acid ≥6 mg/dL
  6. Prescriber specialty (rheumatologist preferred)

Example PA Request Structure

Patient: [Name], DOB [Date], Aetna ID [Number]
Diagnosis: Chronic tophaceous gout (M1A.9XX1)
Drug: Krystexxa (pegloticase) 8mg IV q2weeks
HCPCS: J2507 x 8 units per administration

Prior Therapies:
- Allopurinol 300mg daily x 6 months (2023): SUA remained 8.2 mg/dL, continued flares
- Febuxostat 80mg daily x 4 months (2024): Discontinued due to hepatotoxicity

Labs:
- G6PD: Normal (verify with the source linked below)
- Baseline SUA: 9.1 mg/dL
- Recent flare frequency: 4 episodes in past 6 months

Plan: Krystexxa 8mg IV q2weeks with methotrexate 15mg weekly co-therapy
Prescriber: Dr. [Name], Rheumatology

Frequent Coding Pitfalls

Avoid these common errors that lead to denials:

Unit Conversion Mistakes

  • Wrong: Billing J2507 x 1 for 8mg dose
  • Right: Billing J2507 x 8 for 8mg dose

ICD-10 Specificity Issues

  • Wrong: Using M10.*** (acute gout) instead of M1A.*** (chronic gout)
  • Right: Complete 7-character M1A code with joint and tophus specification

Missing Documentation

  • Wrong: Submitting PA without G6PD results
  • Right: Including all required lab values and prior therapy details

Modifier Confusion

  • Wrong: Omitting JW/JZ modifiers for drug wastage
  • Right: Appropriate modifier based on actual vial usage

Verification with Aetna Resources

Before submitting your prior authorization, verify requirements through official Aetna channels:

Key Resources

  • Aetna Provider Portal: Current PA forms and clinical policies
  • CVS Specialty Pharmacy: Drug-specific billing guidance
  • Aetna Medical Policy: Search for "pegloticase" or "Krystexxa"
  • Provider Services: 1-800-624-0756 for PA status and requirements

Cross-Check Your Codes

  1. Confirm J2507 is on Aetna's covered drug list
  2. Verify current PA form version (forms update regularly)
  3. Check for any new clinical policy updates
  4. Confirm infusion site requirements

Quick Pre-Submission Audit Checklist

Use this checklist before submitting your Krystexxa prior authorization:

Clinical Documentation:

  • Complete M1A.*** ICD-10 code with all 7 characters
  • Documented failure of allopurinol AND febuxostat
  • G6PD test results (normal/negative)
  • Methotrexate co-therapy plan or contraindication rationale
  • Baseline serum uric acid ≥6 mg/dL
  • Recent flare history or tophus documentation

Coding Accuracy:

  • J2507 units match actual mg dose (8 units for 8mg)
  • Appropriate JW or JZ modifier
  • Site of service code matches infusion location
  • NDC 75987-0080-10 documented
  • Infusion CPT codes included (96365, 96366)

Administrative:

  • Current Aetna PA form version
  • Prescriber specialty noted (rheumatologist preferred)
  • All required signatures and dates
  • Supporting lab reports attached

Appeals Process in Pennsylvania

If Aetna denies your Krystexxa prior authorization, Pennsylvania offers a robust appeals pathway with strong patient protections.

Internal Appeals (First Step)

  • Timeline: Submit within 180 days of denial
  • Decision timeframe: 30 days (standard), 72 hours (urgent)
  • How to submit: Aetna member portal or written request
  • Required: Copy of denial letter, supporting medical records

Pennsylvania External Review (Final Step)

Pennsylvania launched its independent external review program in January 2024, with impressive success rates for patients.

Key Statistics:

  • Overturn rate: Approximately 50% of denials are reversed
  • Timeline: Most decisions within 60 days, urgent cases within 72 hours
  • Cost: Free to patients

How to Request External Review:

  1. Complete Aetna's internal appeal process first
  2. Submit request within 4 months of final denial
  3. File online at pa.gov/reviewmyclaim or call 1-877-881-6388
  4. Provide denial letters and supporting medical documentation
Note: External review is available for commercial insurance plans but not self-funded employer plans. Confirm your plan type with HR if uncertain.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
"Not medically necessary" Provide detailed prior therapy failures Complete trial history with dates, doses, outcomes
"Step therapy not met" Document allopurinol AND febuxostat failures Lab results showing inadequate SUA control
"Missing G6PD results" Order and submit G6PD screening Lab report showing normal/negative result
"Prescriber not qualified" Ensure rheumatologist prescription Referral to or consultation with rheumatology
"Methotrexate not addressed" Include MTX co-therapy plan Treatment protocol or contraindication rationale
"Incorrect coding" Verify J2507 units calculation 8 units for 8mg dose, appropriate modifiers

From our advocates: We've seen cases where patients initially denied for "experimental" designation succeeded on appeal by submitting the FDA approval letter and current prescribing information, clearly establishing Krystexxa as an approved therapy for refractory chronic gout. This documentation often resolves coverage disputes quickly.

FAQ

How long does Aetna prior authorization take for Krystexxa in Pennsylvania? Standard prior authorizations take 30-45 days. Urgent requests (when delay threatens health) are decided within 72 hours. Submit complete documentation to avoid delays.

What if Krystexxa is non-formulary on my Aetna plan? Request a formulary exception with medical necessity documentation. Non-formulary doesn't mean non-covered—it typically means higher cost-sharing or additional requirements.

Can I request an expedited appeal in Pennsylvania? Yes, for urgent health situations. Both Aetna's internal process and Pennsylvania's external review offer expedited timelines (72 hours) when delay could seriously jeopardize your health.

Does step therapy apply if I failed these drugs in another state? Yes, prior therapy failures from any location count toward step therapy requirements. Ensure you have complete medical records documenting the failures.

What happens if I'm on a self-funded employer plan? Self-funded plans aren't subject to Pennsylvania's external review program. However, you can still appeal through your plan's internal process and may have federal external review options.

How much does Krystexxa cost without insurance? Approximately $30,000 per infusion, with annual costs potentially reaching $780,000. Patient assistance programs through Amgen may help reduce out-of-pocket costs.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through targeted, evidence-backed strategies. Our platform analyzes denial letters, identifies the specific basis for denial, and generates point-by-point rebuttals aligned with each payer's own policies and procedures. For complex cases like Krystexxa prior authorizations, Counterforce Health streamlines the appeals process by pulling relevant clinical evidence and weaving it into compelling medical necessity arguments that meet Aetna's specific requirements.

If you need assistance navigating the Krystexxa approval process or appealing a denial, consider reaching out to Counterforce Health for expert guidance tailored to your specific situation and insurance plan.

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 determinations. Coverage policies and requirements may change; verify current information with official sources before making healthcare decisions.

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