By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (danicopan) Covered by UnitedHealthcare in New Jersey: Coding, Appeals, and Prior Authorization Guide

Answer Box: Getting Voydeya Covered by UnitedHealthcare in New Jersey

Voydeya (danicopan) requires prior authorization from UnitedHealthcare for paroxysmal nocturnal hemoglobinuria (PNH). Key requirements: ICD-10 code D59.5, proof of extravascular hemolysis despite C5 inhibitor therapy, completed vaccinations (meningococcal, pneumococcal, Hib), and REMS enrollment. Submit via UnitedHealthcare Provider Portal with flow cytometry results and clinical documentation. If denied, New Jersey residents can appeal through internal processes then escalate to the state's IHCAP external review program at no cost.

First step today: Verify your UnitedHealthcare plan covers specialty pharmacy benefits and gather vaccination records, flow cytometry results, and C5 inhibitor treatment history.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for PNH
  3. Product Coding: HCPCS, J-Codes, and NDC
  4. Clean Prior Authorization Request
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare
  7. Appeals Process in New Jersey
  8. Quick Audit Checklist
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Voydeya (danicopan) is an oral specialty medication that falls under the pharmacy benefit (Medicare Part D equivalent), not the medical benefit (Part B). This distinction is crucial for proper billing and prior authorization routing.

Key Coverage Points:

  • Benefit type: Pharmacy/prescription drug coverage
  • Prior authorization: Required through OptumRx (UnitedHealthcare's pharmacy benefit manager)
  • Specialty tier: Typically tier 4 or 5 on formularies
  • Site of care: Home administration (oral tablets)

UnitedHealthcare has been streamlining prior authorization processes, eliminating PA requirements for 80+ chronic disease drugs as of 2024. However, Voydeya remains subject to prior authorization due to its specialty status and high cost (estimated $50,000-$100,000 annually).

ICD-10 Mapping for PNH

The primary diagnosis code for paroxysmal nocturnal hemoglobinuria is D59.5 (Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]). This billable code falls under chapter D59 (Acquired hemolytic anemias).

Documentation Requirements

Essential clinical documentation includes:

  • Flow cytometry results showing GPI-anchor deficient clones
  • Evidence of extravascular hemolysis (EVH) despite C5 inhibitor therapy
  • Laboratory values: elevated LDH, low haptoglobin, reticulocytosis
  • Negative direct antiglobulin test (DAT/Coombs-negative)

Supporting codes that may apply:

  • D59.9: Acquired hemolytic anemia, unspecified (if EVH predominant)
  • R10.9: Unspecified abdominal pain (for symptom documentation)
  • I82: Portal vein thrombosis (if complications present)
Tip: Always use D59.5 as the primary code, but document specific symptoms and complications to support medical necessity.

Product Coding: HCPCS, J-Codes, and NDC

HCPCS J-Code

J8499 ("Prescription drug, oral, non-chemotherapeutic, NOS") until a specific code is assigned for Voydeya.

NDC Codes and Units

  • 25682-043-04: 42-tablet blister pack
  • 25682-043-92: 200 mg dose package (3x/day carton)
  • 25682-046-92: 150 mg dose package (3x/day carton)

Critical billing note: Bill 1 unit per tablet, not per milligram. This prevents common dosing errors that can delay approval.

Dosing Information

  • Standard dose: 150 mg three times daily
  • Maximum dose: 200 mg three times daily based on response
  • Administration: With or without food
  • Duration: Continuous therapy as add-on to C5 inhibitor

Clean Prior Authorization Request

Required Documentation Checklist

Clinical Information:

  • ✅ PNH diagnosis confirmed by flow cytometry
  • ✅ ICD-10 code D59.5 documented
  • ✅ Evidence of inadequate response to C5 inhibitor alone
  • ✅ Laboratory evidence of ongoing extravascular hemolysis
  • ✅ Specialist (hematologist) prescriber or consultation notes

REMS and Safety Requirements:

  • ✅ Completed meningococcal vaccinations (MenACWY + MenB series) ≥2 weeks prior
  • ✅ Pneumococcal and Hib vaccinations current
  • ✅ Prescriber enrolled in Voydeya REMS program
  • ✅ Patient counseling on infection risks documented

Submission Process:

  1. Submit via UnitedHealthcare Provider Portal
  2. Include all vaccination records and dates
  3. Attach flow cytometry results and recent labs
  4. Provide detailed treatment history with C5 inhibitors

Counterforce Health specializes in helping patients and providers navigate complex prior authorization requirements for specialty medications like Voydeya. Their platform can help identify the specific denial reasons and draft targeted appeals based on UnitedHealthcare's own policies.

Frequent Coding Pitfalls

Common Errors to Avoid

Unit Conversion Mistakes:

  • ❌ Billing milligrams instead of tablets
  • ✅ Use 1 unit = 1 tablet for accurate billing

Diagnosis Code Issues:

  • ❌ Using D59.9 (unspecified) as primary code
  • ✅ Always use D59.5 for confirmed PNH

Missing Documentation:

  • ❌ Submitting PA without vaccination records
  • ✅ Include complete vaccination history with dates

Benefit Confusion:

  • ❌ Trying to bill under medical benefit (Part B)
  • ✅ Route through pharmacy benefit (Part D equivalent)

REMS Compliance:

  • ❌ Starting therapy before prescriber REMS enrollment
  • ✅ Complete REMS enrollment before first prescription

Verification with UnitedHealthcare Resources

Pre-Submission Verification Steps

  1. Check formulary status via UnitedHealthcare member portal
  2. Verify PA requirements through OptumRx guidelines
  3. Confirm specialist network status for prescribing physician
  4. Review plan-specific coverage policies for PNH treatments

Key UnitedHealthcare Resources

  • Provider Portal: UHCprovider.com
  • Prior Authorization Status: TrackIt system within provider portal
  • OptumRx PA Guidelines: 1-800-711-4555
  • Peer-to-Peer Review: Available within 24 hours of denial

Recent Policy Updates: UnitedHealthcare has implemented PreCheck Prior Authorization for instant approvals on select medications, though Voydeya is not currently included in this streamlined process.

Appeals Process in New Jersey

Internal Appeals with UnitedHealthcare

Step 1: Claim Reconsideration

  • Timeline: Within 12 months of denial
  • Method: Electronic submission via Provider Portal preferred
  • Documentation: Include all original PA materials plus additional supporting evidence

Step 2: Internal Appeal

  • Timeline: After unsatisfactory reconsideration
  • Expedited option: Available for pre-service denials threatening health
  • Peer-to-peer: Request within 24 hours of denial

New Jersey IHCAP External Review

If internal appeals are unsuccessful, New Jersey residents have access to the Independent Health Care Appeals Program (IHCAP) for external review at no cost.

IHCAP Process:

  • Eligibility: Fully insured individual/family plans (not self-funded ERISA plans)
  • Timeline: File within 4 months (180 days) of final internal denial
  • Contact: 1-888-393-1062 or online at nj.gov/dobi/ihcap
  • Success rate: Approximately 45-50% of appeals favor consumers
  • Decision timeline: 20-45 days for standard review

Required Documentation for IHCAP:

  • Final denial letter from UnitedHealthcare
  • Complete medical records related to PNH diagnosis and treatment
  • Peer-reviewed studies supporting Voydeya use
  • Physician letter explaining medical necessity
Note: The external review process is managed by Maximus Federal Services under contract with New Jersey's Department of Banking and Insurance.

When preparing appeals, Counterforce Health can help identify the specific denial reasons in your UnitedHealthcare letter and craft point-by-point rebuttals using evidence that aligns with the plan's own coverage policies.

Quick Audit Checklist

Pre-Submission Review

Coding Accuracy:

  • ICD-10 D59.5 used as primary diagnosis
  • J8499 HCPCS code with correct NDC
  • Units calculated as tablets, not milligrams
  • Prescriber NPI and specialty verified

Clinical Documentation:

  • Flow cytometry results confirming PNH diagnosis
  • Evidence of extravascular hemolysis despite C5 inhibitor
  • Complete vaccination records with dates
  • REMS enrollment confirmation
  • Specialist consultation or prescriber credentials

Administrative Requirements:

  • Prior authorization submitted via correct portal
  • Patient insurance eligibility verified
  • Pharmacy benefit coverage confirmed
  • Required forms and attachments included

FAQ

Q: How long does UnitedHealthcare prior authorization take for Voydeya in New Jersey? A: Standard PA decisions are typically made within 5-7 business days. Expedited reviews for urgent cases may be completed within 72 hours.

Q: What if Voydeya is not on my UnitedHealthcare formulary? A: Non-formulary medications can still be covered through the exception process. Submit a formulary exception request with strong clinical justification and supporting literature.

Q: Can I request an expedited appeal if my Voydeya is denied? A: Yes, expedited appeals are available for pre-service denials where delays could threaten your health or functional ability.

Q: Does step therapy apply to Voydeya since it's used with C5 inhibitors? A: Voydeya is specifically indicated as add-on therapy to C5 inhibitors, so traditional step therapy may not apply. However, you may need to document adequate trial of C5 inhibitor monotherapy first.

Q: What vaccination requirements must be met before starting Voydeya? A: Complete meningococcal (MenACWY + MenB), pneumococcal, and Hib vaccinations at least 2 weeks before starting therapy, unless urgent treatment is needed.

Q: How much will Voydeya cost with UnitedHealthcare coverage? A: Costs vary by plan, but specialty tier medications typically have higher copays. Check your plan's Summary of Benefits and consider manufacturer copay assistance programs.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may vary by individual plan and change over time. Always consult your healthcare provider and insurance plan directly for the most current information specific to your situation. For additional assistance with complex prior authorization cases, Counterforce Health offers specialized support in navigating insurance approvals for specialty medications.

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