By Counterforce Health Team in Kesimpta (ofatumumab) —

How to Get Kesimpta (ofatumumab) Covered by UnitedHealthcare in Virginia: Appeals Guide with Forms and Timelines

Answer Box: Getting Kesimpta Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Kesimpta (ofatumumab) with step therapy requirements in Virginia. Most denials stem from missing documentation or inadequate prior DMT failure records. Your fastest path: 1) Gather complete medical records showing relapsing MS diagnosis and prior treatment failures, 2) Submit PA via UHC Provider Portal with neurologist support, 3) If denied, file internal appeal within 180 days, then external review through Virginia's Bureau of Insurance using Form 216-A within 120 days. Standard PA decisions take 72 hours; appeals take 30-60 days internally, 45 days for external review.

Table of Contents

Understanding the Denial

When UnitedHealthcare denies Kesimpta, your denial letter will include specific reason codes. The most common reasons include:

  • Step therapy not met - You haven't tried required first-line MS medications
  • Missing clinical documentation - Incomplete medical records or lab results
  • Non-formulary status - Kesimpta isn't on your specific plan's drug list
  • Quantity limits exceeded - Dosing doesn't match plan parameters

Read every word of your denial letter. It contains critical deadlines (usually 180 days for internal appeals) and specific documentation requirements for your appeal.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization PA required for most UHC plans Completed UHC/OptumRx PA form UHC Provider Portal
Step Therapy Trial of preferred MS drugs first Records of prior DMT failures/intolerances OptumRx formulary policies
Relapsing MS Diagnosis CIS, RRMS, or active SPMS only Neurologist notes with ICD-10 G35 FDA Kesimpta label
Specialist Prescriber Neurologist or MS specialist Provider credentials documentation UHC PA requirements
Safety Screening HBV testing, vaccinations current Lab results, immunization records Kesimpta prescribing information

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage (Patient + Clinic Staff)

Check if your UnitedHealthcare plan uses OptumRx for pharmacy benefits. Call the member services number on your insurance card and ask for your plan's Kesimpta coverage status and PA requirements.

2. Gather Required Documentation (Clinic Staff)

Collect these essential documents:

  • Complete MS diagnosis and treatment history
  • Records of prior DMT trials, failures, or contraindications
  • Recent MRI reports showing disease activity
  • HBV screening results and vaccination records
  • Current neurologist consultation notes

3. Submit Initial PA (Prescriber)

Use the UHC Provider Portal to submit the PA request with all documentation. Timeline: 72 hours for standard decisions, 24 hours for urgent requests.

4. If Denied: Request Peer-to-Peer Review (Prescriber)

Within 24 hours of denial, complete the peer-to-peer scheduling request form on the UHC Provider Portal. This allows your neurologist to speak directly with a UHC medical director.

5. File Internal Appeal (Patient or Prescriber)

If the peer-to-peer doesn't resolve the denial, submit a formal appeal within 180 days via the UHC Provider Portal or member portal. Include additional clinical evidence and a detailed medical necessity letter.

6. External Review in Virginia (Patient)

After exhausting internal appeals, file for external review with Virginia's Bureau of Insurance using Form 216-A within 120 days of the final internal denial.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Step therapy not satisfied Document prior DMT failures or contraindications Treatment timeline showing inadequate response, side effects, or medical contraindications to preferred agents
Missing HBV screening Submit required lab results HBsAg, anti-HBc, and anti-HBs test results
Inadequate diagnosis documentation Provide detailed neurologist notes McDonald criteria-based diagnosis with ICD-10 G35, MRI reports, clinical course
Non-specialist prescriber Show neurologist involvement Consultation notes or co-management documentation
Quantity limits Justify dosing regimen FDA label dosing rationale, patient-specific factors
Tip: OptumRx eliminated reauthorization requirements for Kesimpta in 2024, so once approved, you won't need to repeat the PA process annually.

Appeals Playbook for Virginia

Internal Appeals with UnitedHealthcare

  • First Level: Submit within 180 days of denial
  • Timeline: 30 days for pre-service, 60 days for post-service claims
  • Expedited: 72 hours if delay could jeopardize health
  • How to file: UHC Provider Portal or member portal

External Review in Virginia

After completing UnitedHealthcare's internal process, Virginia law provides additional appeal rights through the State Corporation Commission's Bureau of Insurance.

Key Virginia External Review Details:

  • Filing deadline: 120 days from final internal denial
  • Form required: Form 216-A (External Review Request)
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Cost: Free to consumers
  • Contact: Virginia SCC Consumer Services at 1-877-310-6560

Required documents for external review:

  • Signed medical records release form
  • Copy of insurance card and final denial letter
  • All medical records and clinical documentation
  • Provider letter supporting medical necessity
Note: Virginia's external review process overturns approximately 40-50% of denials when strong clinical documentation is provided.

Medical Necessity Letter Checklist

Clinician Corner: Building a Winning Appeal

Your medical necessity letter should address these key elements:

Diagnosis & Disease Course

  • Confirmed relapsing MS diagnosis using McDonald criteria
  • ICD-10 code G35 with supporting clinical evidence
  • Disease timeline, relapse history, and MRI progression

Prior Treatment Documentation

  • Complete list of previous DMTs with specific details:
    • Drug names, doses, duration of treatment
    • Reason for discontinuation (breakthrough disease, intolerance, contraindications)
    • Clinical outcomes and MRI changes during treatment

Rationale for Kesimpta

  • Why high-efficacy therapy is appropriate
  • Specific benefits of anti-CD20 mechanism
  • Patient-specific factors favoring subcutaneous self-administration

Safety Considerations

  • HBV screening results and vaccination status
  • Absence of contraindications
  • Monitoring plan for ongoing safety

Supporting Evidence

  • Reference FDA-approved indications
  • Cite current MS treatment guidelines supporting early high-efficacy therapy
  • Include recent MRI reports showing active disease

Scripts & Templates

Patient Phone Script for UnitedHealthcare

"I'm calling about a prior authorization denial for Kesimpta for multiple sclerosis. My member ID is [X]. I'd like to understand the specific step therapy requirements and appeal process. Can you transfer me to someone who can walk me through the exact documentation needed?"

Peer-to-Peer Request Script for Clinic Staff

"I'm requesting a peer-to-peer review for [patient name], member ID [X], for a Kesimpta denial. The treating neurologist has additional clinical information about prior treatment failures and disease activity that wasn't included in the initial PA. When can we schedule the call?"

When to Escalate to Virginia Regulators

Contact the Virginia State Corporation Commission Bureau of Insurance if:

  • UnitedHealthcare violates appeal timelines
  • You suspect the denial violates Virginia insurance law
  • The external review process isn't followed properly

Virginia SCC Bureau of Insurance

The Bureau's Managed Care Ombudsman can also help resolve issues informally before filing formal complaints.

Cost-Saving Options

While pursuing coverage, explore these financial assistance options:

Novartis Patient Assistance

Virginia-Specific Resources

  • Virginia Poverty Law Center Health Assistance program
  • Medicaid expansion coverage (available since 2019)
  • Patient advocacy organizations for MS support

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Kesimpta. Their platform analyzes denial letters and creates targeted, evidence-backed appeals that align with each payer's specific requirements, helping patients navigate the complex prior authorization and appeals process more effectively.

FAQ

How long does UnitedHealthcare PA take in Virginia? Standard PA decisions: 72 hours. Urgent requests: 24 hours. Submit 7-10 days before your planned start date to allow for potential appeals.

What if Kesimpta is non-formulary on my plan? Request a formulary exception by documenting why preferred alternatives have failed, caused intolerance, or are contraindicated for your specific situation.

Can I request an expedited appeal? Yes, if your doctor certifies that delay would seriously jeopardize your health. Expedited appeals are decided within 72 hours.

Does step therapy apply if I failed treatments outside Virginia? Yes, prior treatment records from any state are acceptable. Ensure you have complete documentation of the treatment timeline and outcomes.

What happens if external review upholds the denial? The decision is final and binding. Consider alternative treatments, manufacturer assistance programs, or legal consultation if you believe laws were violated.

How much does Kesimpta cost without insurance? As a specialty biologic, costs vary significantly. Contact Novartis patient support for current pricing and assistance program eligibility.

From our advocates: We've seen success rates improve dramatically when patients include a detailed timeline of prior treatments with specific dates, doses, and documented reasons for discontinuation. Insurance reviewers look for clear evidence that preferred drugs were genuinely tried and failed, not just briefly attempted.

For additional support navigating complex insurance appeals, Counterforce Health helps patients and clinicians create targeted appeals that address specific payer requirements and increase approval rates.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage determinations. Insurance policies and requirements may vary by plan and change over time. For current information, contact UnitedHealthcare directly or consult the Virginia State Corporation Commission Bureau of Insurance.

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