By Counterforce Health Team in Rezlidhia (olutasidenib) —

How to Get Rezlidhia (Olutasidenib) Covered by UnitedHealthcare in Virginia: Complete PA Guide and Appeals Process

Answer Box: Getting Rezlidhia Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Rezlidhia (olutasidenib) with strict documentation of IDH1 mutation and relapsed/refractory AML status. Submit via OptumRx e-PA portal with molecular testing results, treatment history, and monitoring plan. If denied, Virginia's State Corporation Commission provides external review within 45 days after internal appeals. Start today: Gather IDH1 mutation report, prior therapy records, and submit PA through UHC provider portal at uhcprovider.com.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for AML Documentation
  3. Product Coding: HCPCS, J-Codes, and NDCs
  4. Clean Request Anatomy: PA Submission
  5. Frequent Pitfalls and How to Avoid Them
  6. Verification Steps with UnitedHealthcare
  7. Quick Audit Checklist
  8. Appeals Playbook for Virginia
  9. Common Denial Reasons & Solutions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Rezlidhia prescriptions OptumRx e-PA portal UHC Provider Portal
IDH1 Mutation FDA-approved test documenting susceptible mutation Molecular pathology report FDA Label
Step Therapy May require ivosidenib or azacitidine+venetoclax first UHC pharmacy policy UHC PA Requirements
Appeals Deadline 180 days from denial for internal appeals Denial letter UHC Provider Manual
Virginia External Review 120 days from final denial notice SCC Bureau of Insurance Virginia SCC

Coding Basics: Medical vs. Pharmacy Benefit

Rezlidhia (olutasidenib) is an oral IDH1 inhibitor that UnitedHealthcare typically covers under the pharmacy benefit with prior authorization through OptumRx. However, some plans allow medical benefit billing when dispensed through hospital-based specialty pharmacies.

Pharmacy Benefit Path (Most Common)

  • NDC: 71332-005-01 (150 mg capsules, 30-count)
  • Submission: OptumRx e-PA portal or UHC provider portal
  • Cost-sharing: Specialty tier copay/coinsurance

Medical Benefit Path (Limited Cases)

  • HCPCS: J8999 (oral chemotherapy, NOS) or J3490 (unclassified drugs)
  • Units: Per 150 mg capsule
  • Place of Service: Outpatient hospital (22) or office (11)
Tip: Verify benefit type before prescribing by checking the patient's formulary or calling UnitedHealthcare at 1-800-711-4555.

ICD-10 Mapping for AML Documentation

Accurate diagnosis coding is critical for Rezlidhia approval. UnitedHealthcare requires documentation of relapsed or refractory AML status.

Primary Diagnosis Codes

  • C92.00 - Acute myeloblastic leukemia, not having achieved remission (refractory)
  • C92.02 - Acute myeloblastic leukemia, in relapse

Documentation Requirements

Your oncology note must explicitly state:

  • "Relapsed AML with IDH1-mutated disease confirmed by FDA-approved assay"
  • Prior treatment regimens and failure/intolerance details
  • Current disease status with bone marrow findings
Note: There's no specific ICD-10 code for IDH1 mutation. This is documented through attached molecular testing reports.

Product Coding: HCPCS, J-Codes, and NDCs

Current Coding Status

Rezlidhia does not have a permanent HCPCS J-code. Payers use miscellaneous drug codes:

Code Description Usage
J8999 Oral chemotherapy, NOS Most common for medical benefit
J3490 Unclassified drugs Alternative miscellaneous code
NDC 71332-005-01 150 mg capsules, 30-count Primary identifier for all claims

Units and Billing

  • Standard dose: 150 mg twice daily (300 mg/day)
  • Billing units: Per 150 mg capsule
  • Monthly quantity: Typically 60 capsules (30-day supply)

When using miscellaneous HCPCS codes, include clear narrative: "Rezlidhia (olutasidenib) 150 mg capsule – oral IDH1 inhibitor for relapsed/refractory IDH1-mutated AML, NDC 71332-005-01."

Clean Request Anatomy: PA Submission

Step-by-Step PA Submission

1. Complete OptumRx PA Form Download from OptumRx provider portal or submit via e-PA integration.

2. Required Clinical Documentation

  • IDH1 mutation report: FDA-approved assay results showing specific variant (R132H, R132C, etc.)
  • AML diagnosis: Pathology confirming WHO criteria, blast count ≥20%
  • Treatment history: Prior regimens, dates, responses, and failure/intolerance documentation
  • Current status: Recent CBC, bone marrow biopsy results
  • Monitoring plan: Differentiation syndrome surveillance protocol

3. Submission Methods (Prioritized)

Method Contact Timeline
e-PA (Preferred) OptumRx e-PA portal Real-time processing
Online Portal UHC Provider Portal 24-48 hours
Fax 1-866-434-5523 (verify current number) 3-5 business days
Phone 1-800-711-4555 Immediate for urgent cases

Frequent Pitfalls and How to Avoid Them

Common Submission Errors

1. Missing IDH1 Mutation Documentation

  • Problem: Generic "IDH mutation positive" without specifics
  • Solution: Include full molecular report with specific variant and testing method

2. Incomplete Treatment History

  • Problem: Vague "failed prior therapy" statements
  • Solution: Document specific regimens, dates, cycles completed, and reason for discontinuation

3. Wrong Benefit Category

  • Problem: Submitting to medical benefit when pharmacy benefit required
  • Solution: Verify formulary status before prescribing via UHC provider portal

4. Inadequate Monitoring Plan

  • Problem: No mention of differentiation syndrome surveillance
  • Solution: Include specific monitoring schedule per FDA labeling

Verification Steps with UnitedHealthcare

Pre-Submission Checklist

1. Confirm Plan Type

  • Check if fully-insured Virginia plan (subject to state external review)
  • Verify OptumRx pharmacy benefit management

2. Review Current Formulary

3. Check Step Therapy Requirements UnitedHealthcare may require trial of:

  • Ivosidenib (Tibsovo) - preferred IDH1 inhibitor
  • Azacitidine + venetoclax combination
  • Document medical necessity if alternatives contraindicated

4. Verify Prescriber Requirements

  • Board-certified hematologist/oncologist
  • Experience with differentiation syndrome management
  • Access to emergency interventions if needed

Quick Audit Checklist

Before submitting your Rezlidhia PA request, ensure you have:

  • Patient eligibility: Adult (≥18 years) with UnitedHealthcare coverage
  • Diagnosis documentation: C92.00 or C92.02 with supporting pathology
  • IDH1 mutation report: FDA-approved test with specific variant
  • Treatment history: Complete prior therapy timeline with outcomes
  • Current status: Recent labs and bone marrow findings
  • Monitoring plan: Differentiation syndrome surveillance protocol
  • Prescriber qualifications: Board-certified hematologist/oncologist
  • Correct coding: NDC 71332-005-01 and appropriate HCPCS if needed
  • Submission method: OptumRx e-PA or UHC provider portal

Appeals Playbook for Virginia

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial notice Submission: UHC Provider Portal or written appeal

Required Elements:

  • Copy of original denial letter
  • Additional clinical documentation
  • Medical necessity letter addressing denial reasons
  • Peer-reviewed literature supporting Rezlidhia use

Virginia External Review Process

After exhausting UnitedHealthcare's internal appeals, Virginia residents can request external review through the State Corporation Commission.

Eligibility: Final adverse determination based on medical necessity Deadline: 120 days from notice of right to external review Timeline: 45 days for standard review, 72 hours for expedited

How to File:

  • Email: [email protected]
  • Fax: (804) 371-9915
  • Mail: SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218

Required Documents:

  • Virginia External Review Request Form
  • Copy of UnitedHealthcare's final denial
  • All supporting medical records
  • Provider's letter of medical necessity
Special Virginia Provision: Cancer treatment denials may proceed directly to external review without exhausting internal appeals.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing IDH1 mutation Submit complete molecular report FDA-approved test results with specific variant
Step therapy not met Document medical necessity exception Prior therapy failures or contraindications
Non-oncology prescriber Transfer to hematologist/oncologist Board certification verification
Inadequate monitoring plan Enhance safety protocol Differentiation syndrome management plan
Off-label use Confirm FDA indication Relapsed/refractory AML documentation

Strengthening Your Appeal

Medical Necessity Letter Components:

  1. Patient summary: Age, diagnosis, IDH1 mutation status
  2. Treatment history: Prior regimens and outcomes
  3. Clinical rationale: Why Rezlidhia is medically necessary
  4. Guideline support: FDA labeling and NCCN references
  5. Monitoring plan: Safety surveillance protocol

Supporting Evidence:

  • FDA approval letter for relapsed/refractory IDH1-mutated AML
  • Peer-reviewed studies demonstrating efficacy
  • NCCN Guidelines supporting IDH1 inhibitor use
  • Patient-specific factors favoring Rezlidhia over alternatives

When to Escalate

Contact Virginia's Bureau of Insurance if:

  • UnitedHealthcare delays processing beyond stated timelines
  • Denial appears to contradict plan documents
  • External review decision is not implemented promptly

Virginia SCC Consumer Services: 1-877-310-6560

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Rezlidhia. Our platform analyzes denial letters, identifies specific deficiencies, and generates evidence-backed appeals tailored to each payer's requirements. We help patients, clinicians, and specialty pharmacies navigate complex prior authorization processes with higher approval rates.

From Our Advocates: "We've seen UnitedHealthcare approvals increase significantly when the IDH1 mutation report explicitly names the specific variant and testing methodology. Including the exact FDA-approved assay used often resolves 'insufficient documentation' denials without requiring appeals."

FAQ

Q: How long does UnitedHealthcare PA take for Rezlidhia in Virginia? A: Standard PA decisions within 72 hours via e-PA portal, up to 14 days for complex cases. Expedited review available for urgent situations.

Q: What if Rezlidhia is non-formulary on my UnitedHealthcare plan? A: Submit formulary exception request with medical necessity documentation. Non-formulary drugs may require higher cost-sharing but can be covered.

Q: Can I request expedited appeal for Rezlidhia denial? A: Yes, if delay could seriously jeopardize health. Virginia allows expedited external review for cancer treatments within 72 hours.

Q: Does step therapy apply if I failed therapies outside Virginia? A: Prior therapy failures from any location count toward step therapy requirements. Include complete treatment records regardless of where care was received.

Q: What's the cost of Rezlidhia with UnitedHealthcare coverage? A: Specialty tier cost-sharing applies, typically $50-200 copay or 25-40% coinsurance. Check with Rigel Pharmaceuticals for patient 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 plan. Always consult with your healthcare provider and insurance plan for the most current information. For additional support with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance or consider working with specialized advocacy services like Counterforce Health.

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