By Counterforce Health Team in Besponsa (inotuzumab ozogamicin) —

How to Get Besponsa (Inotuzumab Ozogamicin) Covered by UnitedHealthcare in Virginia: Complete Guide to Prior Authorization, Appeals, and State Protections

Answer Box: Getting Besponsa Covered in Virginia

Besponsa (inotuzumab ozogamicin) requires prior authorization from UnitedHealthcare in Virginia. Your oncologist must document CD22-positive B-cell ALL, failed prior chemotherapy, and a hepatic monitoring plan. If denied, Virginia offers strong consumer protections: you can appeal internally (180 days), then request external review through the State Corporation Commission using Form 216-A within 120 days. First step today: Have your oncologist begin PA submission through the UnitedHealthcare Provider Portal with complete clinical documentation.

Table of Contents

  1. Why Virginia State Rules Matter
  2. UnitedHealthcare Prior Authorization Requirements
  3. Virginia's Turnaround Standards
  4. Step Therapy Protections and Medical Exceptions
  5. Continuity of Care During Treatment
  6. External Review and State Appeals Process
  7. Practical Scripts and Documentation
  8. Understanding ERISA Limitations
  9. Quick Reference: Virginia Resources
  10. FAQ

Why Virginia State Rules Matter

Virginia's insurance laws provide crucial protections that work alongside UnitedHealthcare's policies. The state has significantly improved healthcare access—the uninsured rate dropped to a historic low of 6.4% in 2023 after Medicaid expansion. For specialty drugs like Besponsa, Virginia's regulations ensure fair review processes and consumer protections.

Key Virginia advantages:

  • 72-hour response requirement for step therapy exceptions with medical justification
  • External review rights through an independent process after internal appeals
  • Managed Care Ombudsman assistance for navigating complex denials
  • No-cost external review (Virginia doesn't charge fees)

The State Corporation Commission's Bureau of Insurance oversees these protections, ensuring UnitedHealthcare follows state standards for oncology drug coverage.

UnitedHealthcare Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Documentation Needed Source
PA Required Yes, through OptumRx Oncologist submission only UHC Provider Portal
Formulary Status Specialty tier, step therapy Prior failed therapies OptumRx Formulary
Diagnosis CD22-positive B-cell ALL Lab confirmation, pathology UHC PA Requirements
Line of Therapy Relapsed/refractory only Treatment history records FDA Label Requirements
Prescriber Oncologist/hematologist Board certification UHC Policy
Monitoring Plan Hepatic function protocol Safety monitoring plan FDA Boxed Warning

Step-by-Step: Fastest Path to Approval

  1. Gather Clinical Documentation (Patient/Clinic)
    • CD22-positive ALL confirmation
    • Complete treatment history showing failed prior therapies
    • Current labs including liver function tests
    • Timeline: 1-2 days
  2. Oncologist Submits PA (Clinic)
  3. UnitedHealthcare Review (Insurer)
    • Standard review: 5-15 business days
    • Expedited review: within 72 hours if medically justified
    • Source: UHC Administrative Guide
  4. If Approved (All parties)
    • Coordinate with OptumRx specialty pharmacy
    • Schedule infusion appointments
    • Timeline: 1-3 days for first shipment

Virginia's Turnaround Standards

Virginia law requires specific response times that UnitedHealthcare must follow:

Standard Prior Authorization:

  • Commercial plans: 15 calendar days maximum
  • Medicare Advantage: 14 calendar days
  • Medicaid: 14 calendar days

Expedited Reviews:

  • All plan types: 72 hours when medically justified
  • Exigent circumstances: 24 hours (life-threatening situations)
Note: These are Virginia maximums. UnitedHealthcare often responds faster, typically within 5-15 business days for standard reviews.

Step Therapy Protections and Medical Exceptions

Virginia Code §38.2-3407.9:05 provides strong step therapy override protections for oncology drugs. UnitedHealthcare must approve exceptions when:

Medical Exception Criteria

  • Contraindicated: Drug poses safety risk (e.g., hepatotoxicity in patients with liver impairment)
  • Ineffective: Drug unlikely to work based on patient characteristics
  • Previous failure: Patient discontinued due to adverse effects or lack of efficacy
  • Current success: Patient stable on alternative therapy

Documentation for Hepatotoxicity Concerns

For Besponsa, which carries an FDA boxed warning for hepatotoxicity and veno-occlusive disease (VOD), document:

  • Baseline liver function tests
  • History of hepatic impairment
  • Risk factors for VOD (prior stem cell transplant, hepatic disease)
  • Monitoring plan with specific parameters

Response timeline: UnitedHealthcare must respond within 72 hours (24 hours for exigent cases).

From our advocates: We've seen successful step therapy overrides when providers clearly document hepatic risk factors and reference Virginia's statutory criteria. One case involved a patient with elevated baseline liver enzymes—the override was approved within 48 hours when the oncologist cited specific lab values and Virginia Code §38.2-3407.9:05 in the request.

Continuity of Care During Treatment

If your oncologist leaves UnitedHealthcare's network during Besponsa treatment, Virginia and federal protections ensure uninterrupted care:

Grace Period Protections

  • Duration: Up to 90 days of continued in-network coverage
  • Eligibility: Active treatment for serious conditions (cancer qualifies)
  • Process: Complete UnitedHealthcare's Transition of Care form within 30 days

Required Documentation

  • Medical records showing ongoing treatment necessity
  • Treatment timeline from oncologist
  • Confirmation of active therapy status

Contact UnitedHealthcare member services immediately if your provider leaves the network to initiate continuity protections.

External Review and State Appeals Process

When UnitedHealthcare denies Besponsa coverage, Virginia offers robust external review rights through the State Corporation Commission.

Internal Appeals First

  • Deadline: 180 days from denial
  • Levels: Typically 1-2 internal review levels
  • Documentation: Submit all supporting clinical evidence

External Review Process

After completing internal appeals, you can request independent external review:

  1. Eligibility: Medical necessity or experimental/investigational denials only
  2. Deadline: 120 days from final internal denial
  3. Form: Form 216-A (External Review Request)
  4. Cost: Free (Virginia doesn't charge fees)

Required Documents for Form 216-A

  • Copy of UnitedHealthcare's final denial letter
  • Insurance card copy
  • Signed medical records release
  • Any new clinical evidence not submitted in internal appeals

Submission Options

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

Review timeline: 45 days standard, 72 hours expedited (with physician certification via Form 216-C)

For assistance with Besponsa appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to plan policies.

Practical Scripts and Documentation

Patient Phone Script for UnitedHealthcare

"Hello, I'm calling about prior authorization for Besponsa for my CD22-positive B-cell ALL. My oncologist submitted the PA on [date]. Can you provide the status and reference number? If denied, I need the specific denial reasons and information about internal appeals. I'm also requesting expedited review due to my cancer diagnosis."

Clinician Documentation Checklist

Medical Necessity Letter must include:

  • Confirmed CD22-positive B-cell ALL diagnosis with ICD-10 code
  • Complete prior treatment history and outcomes
  • Clinical rationale referencing FDA labeling and guidelines
  • Specific dosing plan and cycle schedule
  • Hepatic monitoring protocol addressing VOD risk
  • Treatment goals and expected outcomes

Appeal Letter Template Paragraph

"Per Virginia Code §38.2-3407.9:05, I request a step therapy exception for Besponsa (inotuzumab ozogamicin). The required first-line therapy is contraindicated due to [specific clinical reason]. Attached documentation includes [list specific evidence]. This request meets Virginia's statutory criteria for medical exception based on contraindication."

Understanding ERISA Limitations

Important limitation: If you have UnitedHealthcare coverage through a self-funded employer plan, Virginia's external review process may not apply. These plans are governed by federal ERISA law, which can preempt state protections.

How to Determine Your Plan Type

  • Check your insurance card for "insured by" vs. "administered by"
  • Contact HR to ask if the plan is self-funded
  • Self-funded plans typically have different appeal procedures

ERISA Plan Appeals

  • Follow the plan's internal appeal process
  • After exhausting internal appeals, you may have federal external review rights through HHS
  • Consider consulting an ERISA attorney for complex denials

Quick Reference: Virginia Resources

State Assistance

  • Managed Care Ombudsman: 1-877-310-6560
  • Bureau of Insurance Consumer Services: 1-800-552-7945
  • Virginia Insurance Counseling (VICAP): 1-800-552-3402

Forms and Information

Medicaid/FAMIS Appeals

  • Managed Care Help Line: 1-800-643-2273
  • DMAS Appeals Division: 804-371-8488, [email protected]

For complex Besponsa coverage challenges, Counterforce Health provides specialized assistance with insurance appeals, helping patients navigate payer-specific workflows and evidence requirements.

FAQ

How long does UnitedHealthcare PA take in Virginia? Standard review takes 5-15 business days, but Virginia law requires decisions within 15 calendar days maximum. Expedited review (with medical justification) must be completed within 72 hours.

What if Besponsa is non-formulary on my plan? Non-formulary drugs can still be covered with prior authorization and medical necessity documentation. Focus on demonstrating that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal? Yes, if your oncologist certifies that delay could seriously jeopardize your health. Submit Form 216-C with your external review request for 72-hour expedited processing.

Does step therapy apply if I failed treatments in another state? Yes, treatment history from any location counts toward step therapy requirements. Ensure all prior therapy records are included in your PA submission.

What happens if UnitedHealthcare approves PA but limits quantity? Quantity limits can be appealed separately. Your oncologist should document the medical necessity for the prescribed quantity based on FDA labeling and clinical guidelines.

How much does Besponsa cost without insurance? Wholesale acquisition cost (WAC) is approximately $8,700 per 0.9-mg vial, with treatment requiring multiple vials per cycle. Pfizer offers patient assistance programs for eligible patients.

Can I use Pfizer's patient assistance during appeals? Yes, Pfizer's oncology patient assistance program may provide temporary access while appeals are pending. Contact Pfizer Oncology Together at 1-877-744-5675.

What if my employer plan is self-funded? Self-funded ERISA plans may not be subject to Virginia's external review process. You may have federal external review rights through HHS after exhausting internal appeals.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for specific guidance. For personalized assistance with coverage appeals, contact the Virginia Bureau of Insurance Consumer Services at 1-800-552-7945.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.