By Counterforce Health Team in Pyrukynd (mitapivat) —

How to Get Pyrukynd (mitapivat) Covered by Aetna CVS Health in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Pyrukynd (mitapivat) Covered by Aetna CVS Health in New York

Pyrukynd (mitapivat) requires prior authorization from Aetna CVS Health and is listed as non-formulary on most 2024-2025 plans. To get approved in New York: (1) Ensure your hematologist has genetic confirmation of pyruvate kinase deficiency with ≥2 PKLR variants, (2) Submit PA via Aetna Provider Portal with hemoglobin ≤10 g/dL or transfusion history, and (3) If denied, file internal appeal within 180 days, then external review through New York DFS within 60 days of final denial.

First step today: Contact your hematologist to order PKLR genetic testing if not completed and gather 12-month hemoglobin/transfusion records for PA submission.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Pyruvate Kinase Deficiency
  3. Product Coding: NDC, HCPCS, and Units
  4. Clean Request Anatomy: PA Submission
  5. Frequent Pitfalls and How to Avoid Them
  6. Verification with Aetna CVS Health
  7. Quick Audit Checklist
  8. Appeals Playbook for New York
  9. Common Denial Reasons & Fixes
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Pyrukynd (mitapivat) is an oral specialty medication typically covered under the pharmacy benefit through CVS Specialty or designated specialty pharmacies. Understanding the benefit pathway is crucial for proper coding and billing.

Pharmacy Benefit (Most Common)

  • Billing method: NDC-based through NCPDP claims
  • Units: Tablets (not mg or mg/kg)
  • PA required: Yes, through CVS Caremark
  • Specialty pharmacy: CVS Specialty or plan-designated provider

Medical Benefit (Rare Cases)

  • HCPCS code: J8499 (unclassified oral drug) + NDC
  • Units: Based on tablets dispensed
  • Documentation: Invoice and NDC details required
Tip: Always verify benefit pathway with Aetna member services before submission to avoid claim rejections.

ICD-10 Mapping for Pyruvate Kinase Deficiency

The primary diagnosis code for Pyrukynd coverage is D55.21 – Anemia due to pyruvate kinase deficiency. This is a billable, specific code that payers expect for medical necessity.

Documentation Requirements

Your medical record must clearly support D55.21 with specific language:

Required phrases:

  • "Anemia due to pyruvate kinase deficiency"
  • "Pyruvate kinase deficiency anemia"
  • "Hereditary non-spherocytic hemolytic anemia due to pyruvate kinase deficiency"

Supporting clinical details:

  • PKLR gene mutation confirmation
  • Chronic hemolytic anemia with reticulocytosis
  • Baseline hemoglobin levels
  • Transfusion history (dates and frequency)
  • Hemolysis markers (LDH, bilirubin, haptoglobin)

Additional Codes to Consider

  • D73.1 – Splenomegaly (if documented and addressed)
  • E83.10 – Iron overload from transfusions (if clinically relevant)
  • Z87.891 – Personal history of nicotine dependence (if applicable for drug interactions)

Product Coding: NDC, HCPCS, and Units

Pyrukynd is available in three strengths with specific NDCs for each formulation.

NDC Codes by Strength

Strength Common NDCs Package Size
5 mg 71334-205-05, 71334-205-07 28-56 tablets
20 mg 71334-210-07, 71334-210-14 28-56 tablets
50 mg 71334-215-07, 71334-215-14 28-56 tablets
Starter kits 71334-225-12, 71334-230-13 Titration packs

HCPCS Coding (If Required)

  • J8499 – Prescription drug, oral, non-chemotherapeutic, NOS
  • Use only when payer requires HCPCS on medical benefit claims
  • Always include 11-digit NDC in detail

Units Calculation

Standard dosing is twice daily (BID):

  • 5 mg BID = 2 tablets/day × 30 days = 60 tablets/month
  • 20 mg BID = 2 tablets/day × 30 days = 60 tablets/month
  • 50 mg BID = 2 tablets/day × 30 days = 60 tablets/month

Clean Request Anatomy: PA Submission

A successful Aetna CVS Health prior authorization includes these essential components:

Required Documentation Checklist

✅ Patient demographics (name, DOB, member ID)
✅ Prescriber information (hematologist required)
✅ Diagnosis code D55.21 with supporting narrative
✅ PKLR genetic testing (≥2 variants, ≥1 missense, exclude homozygous p.R479H)
✅ Baseline labs (hemoglobin, LDH, bilirubin, reticulocytes)
✅ Transfusion history (dates, units, frequency over 12 months)
✅ Medical necessity letter with FDA indication reference
✅ Dosing plan (starting 5 mg BID, titration schedule)

Submission Methods

  • Primary: Aetna Provider Portal
  • Alternative: CVS Caremark PA system
  • Fax: Check current fax number in provider portal
  • Timeline: 15 business days standard, 72 hours expedited

Frequent Pitfalls and How to Avoid Them

Unit Conversion Errors

❌ Wrong: Billing in mg/day or mg/kg
✅ Right: Bill in tablet units matching strength dispensed

❌ Wrong: Using compound drug codes
✅ Right: Use manufacturer NDCs for oral tablets

Missing Documentation

❌ Wrong: Generic "hemolytic anemia" diagnosis
✅ Right: Specific "anemia due to pyruvate kinase deficiency"

❌ Wrong: Incomplete genetic testing (single variant)
✅ Right: Full PKLR sequencing with ≥2 pathogenic variants

Prescriber Issues

❌ Wrong: Primary care or non-hematology specialist
✅ Right: Board-certified hematologist only

Verification with Aetna CVS Health

Before submitting your PA, verify current requirements:

Key Resources

Cross-Check Points

  1. Formulary status (confirm non-formulary tier)
  2. PA requirements (genetic testing, hematologist)
  3. Quantity limits (monthly supply restrictions)
  4. Step therapy (typically none for Pyrukynd)

Quick Audit Checklist

Before submission, ensure:

Clinical Requirements

  • Patient ≥18 years old
  • Hematologist prescriber
  • D55.21 diagnosis documented
  • PKLR genetic confirmation complete
  • Hemoglobin ≤10 g/dL OR transfusion history documented

Coding Requirements

  • Correct NDC for strength prescribed
  • Tablet units (not mg)
  • Appropriate days supply
  • ICD-10 D55.21 included

Administrative Requirements

  • Complete PA form
  • Medical necessity letter
  • All supporting labs attached
  • Submitted via correct channel

Appeals Playbook for New York

If your initial PA is denied, New York offers robust appeal rights.

Internal Appeals (Required First Step)

  • Deadline: 180 days from denial notice
  • Method: Aetna Provider Portal or written appeal
  • Timeline: 30-45 days standard, 72 hours expedited
  • Requirements: Point-by-point rebuttal of denial reasons

External Review (New York DFS)

After exhausting internal appeals, New York residents can request independent external review:

  • Eligibility: Medical necessity denials >$500 member cost
  • Deadline: 60 days from final internal denial
  • Timeline: 30 days standard, 72 hours expedited
  • Cost: No fee to member
  • Authority: New York Department of Financial Services

Required Documentation for Appeals

  • Original denial letter
  • Complete medical records
  • PKLR genetic testing results
  • Transfusion records
  • FDA labeling for Pyrukynd
  • Medical necessity letter
  • Peer-reviewed literature supporting use
Note: New York's external review decisions are binding on Aetna CVS Health.

Common Denial Reasons & Fixes

Denial Reason How to Fix Documentation Needed
Insufficient genetic testing Submit complete PKLR sequencing Lab report showing ≥2 variants
Hemoglobin too high Provide transfusion history 12-month transfusion records
Non-hematology prescriber Transfer to hematologist New prescription from hematologist
Missing medical necessity Submit detailed letter FDA indication, patient history
Experimental/investigational Cite FDA approval FDA labeling, approval date

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Pyrukynd. Our platform helps identify denial reasons and drafts point-by-point rebuttals aligned with payer policies. Learn more about our appeals assistance.

FAQ

Q: How long does Aetna CVS Health PA take in New York?
A: Standard PA decisions take 15 business days. Expedited reviews for urgent cases are completed within 72 hours.

Q: What if Pyrukynd is non-formulary on my plan?
A: Non-formulary drugs require prior authorization and may have higher copays. You can request a formulary exception with medical necessity documentation.

Q: Can I request an expedited appeal in New York?
A: Yes, if your physician certifies that delay would jeopardize your health. New York expedited external reviews are completed within 72 hours.

Q: Does step therapy apply to Pyrukynd?
A: Aetna CVS Health typically does not require step therapy for Pyrukynd, but genetic confirmation and clinical severity documentation are mandatory.

Q: What's the cost of Pyrukynd without insurance?
A: Wholesale acquisition cost is approximately $25,760 per carton. Check myAgios Patient Support for assistance programs.

Q: Can my primary care doctor prescribe Pyrukynd?
A: No, Aetna CVS Health requires a board-certified hematologist to prescribe Pyrukynd for pyruvate kinase deficiency.

Q: How do I file an external appeal in New York?
A: After exhausting Aetna's internal appeals, submit a request to the New York Department of Financial Services within 60 days of final denial.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements with your plan. For personalized assistance with insurance appeals, consider consulting with organizations like Counterforce Health that specialize in prior authorization and appeals support.

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