By Counterforce Health Team in Idelvion (albutrepenonacog alfa; rFIX-FP) —

Coding That Helps Get Idelvion (albutrepenonacog alfa) Approved by UnitedHealthcare in California: ICD-10, J-Code, and NDC Guide

Answer Box: Getting Idelvion Covered by UnitedHealthcare in California

Idelvion (albutrepenonacog alfa) requires prior authorization from UnitedHealthcare with specific coding: Use ICD-10 code D67 (hereditary factor IX deficiency), HCPCS J7202 (1 IU per billing unit), and the correct NDC for your vial strength. Submit clinical documentation showing hemophilia B diagnosis, inhibitor status, and prior therapy trials. If denied, appeal within 180 days and request California's Independent Medical Review (IMR) for external review. Start today: Verify your plan's formulary status and gather lab results showing factor IX deficiency.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Hemophilia B
  3. Product Coding: J7202, NDC, and Units
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare
  7. Pre-Submission Audit Checklist
  8. Appeals Process in California
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Idelvion (albutrepenonacog alfa) is an extended half-life recombinant factor IX concentrate that's billed under the medical benefit using the buy-and-bill model. This means:

  • Providers purchase and administer the medication, then bill UnitedHealthcare for reimbursement
  • HCPCS J-codes are used instead of pharmacy NDC-only billing
  • Prior authorization is typically required through UnitedHealthcare's medical management team, not OptumRx pharmacy
Note: UnitedHealthcare prefers home self-administration for factor concentrates when clinically appropriate. Clinic administration requires justification for patients under 7 years old, those unable to self-inject, or those without trained caregivers.

The medical benefit pathway means your hemophilia treatment center or infusion clinic handles the coverage approval process, not your retail pharmacy.

ICD-10 Mapping for Hemophilia B

Primary diagnosis code: D67 (Hereditary factor IX deficiency)

This is the only appropriate ICD-10 code for congenital hemophilia B when billing for Idelvion. Documentation must support this coding with:

Required Clinical Documentation

  • Factor IX activity level (typically <1% for severe hemophilia B)
  • Family history of bleeding disorders when available
  • Clinical bleeding history (joint bleeds, muscle hematomas, surgical bleeding)
  • Inhibitor status with titer levels if present

Documentation Words That Support D67 Coding

Include these specific terms in clinical notes:

  • "Hereditary factor IX deficiency"
  • "Congenital hemophilia B"
  • "X-linked recessive bleeding disorder"
  • "Factor IX coagulant activity <40%" (specify actual level)
Important: If an acquired inhibitor is present (not hereditary), use D68.311 instead. However, most Idelvion patients have hereditary hemophilia B requiring D67.

Product Coding: J7202, NDC, and Units

HCPCS J-Code: J7202

J7202 covers "Injection, factor IX, albumin fusion protein, (recombinant), Idelvion, 1 I.U."

  • Billing unit = 1 International Unit (IU)
  • Quantity billed = total IUs administered
  • Example: 2,500 IU dose = 2,500 units of J7202

NDC Codes by Vial Strength

Idelvion is available in multiple vial strengths. Common NDCs include:

Vial Strength NDC Number Typical Use
500 IU 69911-865-02 Pediatric dosing
1000 IU 69911-866-02 Adult maintenance
2000 IU 69911-867-02 Higher dose needs
Tip: Always use the NDC that matches your actual vial strength. Mismatched NDCs can trigger claim denials or audit flags.

Units Calculation

Dosing formula: Weight (kg) × Desired factor IX increase (%) × 1.3 = IU needed

Example for 70kg patient targeting 50% factor IX level:

  • 70 kg × 50% × 1.3 = 4,550 IU
  • Bill: 4,550 units of J7202
  • Use appropriate NDC (likely combination of vials)

JW Modifier for Discarded Drug

If you discard unused medication from single-use vials, apply JW modifier to the discarded units:

  • Line 1: J7202 × 4,550 units (administered dose)
  • Line 2: J7202-JW × 450 units (discarded from 5,000 IU total vials used)

Clean Request Anatomy

Prior Authorization Request Example

Patient Information:

  • Diagnosis: D67 - Hereditary factor IX deficiency
  • Factor IX activity: <1% (severe hemophilia B)
  • Weight: 70 kg
  • Inhibitor status: Negative (<0.6 BU)

Clinical Justification:

  • Breakthrough bleeding on standard factor IX (document frequency)
  • Request for extended half-life product for improved quality of life
  • Dosing plan: 2,000 IU every 10 days for prophylaxis

Supporting Documentation:

  • Recent factor IX activity level
  • Inhibitor titer (negative result)
  • Bleeding log showing current therapy inadequacy
  • Letter of medical necessity from hematologist

Frequent Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing vial quantity instead of total IUs
  • Right: Bill total IUs administered across all vials used

Mismatched Codes

  • Wrong: Using NDC for different vial strength than actually administered
  • Right: NDC must match physical vial(s) used

Missing Start Dates

  • Wrong: Leaving service date blank or using prescription date
  • Right: Use actual administration/infusion date

Incomplete Diagnosis Coding

  • Wrong: Using D68.9 (unspecified coagulation defect)
  • Right: Specific D67 with documented factor IX deficiency

Site of Care Documentation

  • Wrong: Billing for clinic administration without justification
  • Right: Document why home administration isn't appropriate (age, ability, caregiver availability)

Verification with UnitedHealthcare

Check Coverage Status

  1. Provider Portal: Log into UnitedHealthcare Provider Portal to verify:
    • Patient eligibility and benefits
    • Prior authorization requirements
    • Formulary status for J7202
  2. OptumRx Integration: Some plans require coordination with OptumRx for specialty medications
  3. Medical Policy Review: Check current UnitedHealthcare medical policies for hemophilia factor coverage criteria

Pre-Authorization Verification

  • Phone: Call provider services at 866-889-8054
  • Confirm: PA required for J7202 under patient's specific plan
  • Timeline: Standard PA decisions within 15 business days
  • Expedited: Available for urgent clinical situations

Pre-Submission Audit Checklist

Before submitting your Idelvion claim or PA request:

Clinical Documentation ✓

  • ICD-10 D67 supported by lab results
  • Factor IX activity level documented (<40% for hemophilia B)
  • Inhibitor status confirmed (titer result)
  • Prior therapy trials documented if step therapy applies
  • Current bleeding frequency/severity noted

Coding Accuracy ✓

  • J7202 quantity matches total IU administered
  • NDC matches physical vial strength(s) used
  • JW modifier applied to discarded units if applicable
  • Service date is actual administration date
  • Site of care justified if not home administration

Supporting Materials ✓

  • Letter of medical necessity from hematologist
  • Recent lab results (factor levels, inhibitor screen)
  • Prior authorization approval (if obtained)
  • Signed patient consent for treatment

Appeals Process in California

If UnitedHealthcare denies your Idelvion request, California offers robust appeal rights:

Internal Appeals (UnitedHealthcare)

  • Timeline: File within 180 days of denial notice
  • Method: Online portal, phone (866-889-8054), or written appeal
  • Documentation: Include all clinical records supporting medical necessity
  • Decision: Typically within 30 days (expedited available)

Independent Medical Review (IMR)

If internal appeal fails, California's Department of Managed Health Care (DMHC) provides external review:

  • Eligibility: Available for medical necessity denials
  • Timeline: File within 4 months of final internal denial
  • Process: Independent physician experts review case
  • Success Rate: Over 50% of medication denials overturned with strong clinical documentation
  • Cost: Free to patients
  • Contact: DMHC Help Center at 888-466-2219
From our advocates: We've seen several hemophilia B patients successfully overturn UnitedHealthcare denials through California's IMR process. The key is comprehensive documentation showing inadequate response to preferred agents and clear medical necessity for extended half-life factors like Idelvion. Most successful cases included detailed bleeding logs and hematologist attestation letters.

Required IMR Documentation

  • Complete medical records
  • Specialist letter explaining why Idelvion is medically necessary
  • Evidence of prior therapy failures or contraindications
  • Current factor IX levels and inhibitor status
  • Patient's bleeding history and impact on quality of life

Coverage Support Resources

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for specialty medications like Idelvion. Visit counterforcehealth.org to learn more about their coverage support services.

For additional assistance with Idelvion coverage:

  • CSL Behring Patient Support: Access and reimbursement assistance
  • California Chronic Care Coalition: Patient advocacy and IMR guidance
  • Hemophilia Foundation of California: Local support and resources

FAQ

How long does UnitedHealthcare prior authorization take for Idelvion in California? Standard PA decisions are made within 15 business days. Expedited reviews for urgent clinical situations are available within 72 hours.

What if Idelvion is non-formulary on my UnitedHealthcare plan? Non-formulary medications can still be covered with prior authorization and clinical justification. Document medical necessity and why formulary alternatives are inadequate.

Does step therapy apply to Idelvion coverage? Yes, UnitedHealthcare typically requires trial of preferred factor IX products first. Document inadequate response, intolerance, or contraindications to preferred agents.

Can I request expedited appeal if my Idelvion is denied? Yes, expedited appeals are available for urgent clinical situations where delays could harm patient health. Provide clinical documentation supporting urgency.

What documentation strengthens my Idelvion appeal in California? Include factor IX activity levels, inhibitor status, bleeding logs, prior therapy trials, hematologist letter, and evidence of inadequate response to preferred alternatives.

How does California's IMR process work for specialty drug denials? After exhausting internal appeals, patients can request Independent Medical Review through DMHC. Independent physicians review the case and make binding coverage decisions, with over 50% success rate for well-documented cases.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with UnitedHealthcare and consult healthcare providers for medical decisions. For assistance with appeals in California, contact the DMHC Help Center at 888-466-2219.

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