By Counterforce Health Team in Mepsevii (vestronidase alfa-vjbk) —

The Requirements Checklist to Get Mepsevii (vestronidase alfa-vjbk) Covered by UnitedHealthcare in Virginia

Answer Box: Get Mepsevii Covered by UnitedHealthcare in Virginia

Who's eligible: Patients with confirmed MPS VII (Mucopolysaccharidosis Type VII) diagnosed via enzyme assay or genetic testing. Fastest path: Submit prior authorization through OptumRx portal with specialist documentation, enzyme test results, and ICD-10 code E76.29. First step today: Verify your UnitedHealthcare plan requires PA and gather diagnostic records from your metabolic specialist. If denied: Virginia allows external review within 120 days via State Corporation Commission Form 216-A.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Medical Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission
  9. Common Denial Prevention Tips
  10. Virginia Appeals Process
  11. Printable Checklist

Who Should Use This Guide

This comprehensive checklist is designed for patients, families, and healthcare teams seeking UnitedHealthcare coverage for Mepsevii (vestronidase alfa-vjbk) in Virginia. You'll benefit from this guide if you're dealing with:

  • Initial prior authorization requests for confirmed MPS VII patients
  • UnitedHealthcare denials requiring appeal documentation
  • Specialty pharmacy coordination challenges
  • Virginia-specific external review requirements

Expected outcome: With proper documentation following this checklist, most medically appropriate Mepsevii requests receive approval within 5-15 business days. For denials, Virginia's external review process provides an independent pathway with a 45-day decision timeline.

Member & Plan Basics

Coverage Verification Steps

Before starting any prior authorization:

  1. Confirm active UnitedHealthcare coverage - Check member portal or call customer service
  2. Identify your plan type - Commercial, Medicare Advantage, or Medicaid plans have different PA pathways
  3. Verify specialty pharmacy benefits - Mepsevii requires specialty pharmacy distribution through UnitedHealthcare's network
  4. Check deductible status - High-deductible plans may require meeting deductible before coverage begins
Note: UnitedHealthcare requires prior authorization for Mepsevii across all plan types. No exceptions for urgent start scenarios.

Plan-Specific Requirements

Plan Type PA Portal Processing Time Special Notes
Commercial OptumRx Provider Portal 5-15 business days Step therapy not typically required
Medicare Advantage UnitedHealthcare Provider Portal 5-15 business days Expedited review available (72 hours)
Medicaid State-specific portal Varies by state May require additional state forms

Clinical Criteria Requirements

FDA-Approved Indication

Mepsevii is approved for patients with confirmed Mucopolysaccharidosis Type VII (MPS VII, Sly syndrome) who are 5 months of age or older.

Diagnostic Confirmation Required

UnitedHealthcare requires one of the following confirmatory tests:

  • β-glucuronidase enzyme activity assay showing deficient activity in leukocytes, fibroblasts, or dried blood spots
  • Genetic testing confirming pathogenic GUSB gene mutations
  • Elevated urinary glycosaminoglycans (GAGs) with clinical correlation

Specialist Requirements

Prescribing physician must be:

  • Pediatric geneticist
  • Metabolic disease specialist
  • Physician with documented expertise in lysosomal storage diseases

Dosing Requirements

  • Standard dose: 4 mg/kg intravenously every 2 weeks
  • Maximum approved: 460 mg every 14 days
  • Weight-based calculation must be documented with current patient weight

Medical Coding Requirements

Primary Codes for Claims Submission

Code Type Code Description Notes
ICD-10 E76.29 Other mucopolysaccharidoses Required primary diagnosis
HCPCS J3397 Injection, vestronidase alfa-vjbk, 1 mg 1 billable unit = 1 mg
NDC 69794-0001-01 Mepsevii 10 mg/5 mL vial Use 11-digit format

Billing Units and Documentation

  • Bill by milligram: Each J3397 unit represents 1 mg of vestronidase alfa-vjbk
  • NDC reporting: Always include NDC 69794-0001-01 on claims
  • Units format: Report as "UN1" (unit = 1 mg)
Tip: Some Medicaid programs may temporarily require unclassified biologics code J3590. Verify with your state's Medicaid program before submitting.

Documentation Packet

Provider Letter of Medical Necessity Must Include:

Patient Information:

  • Full name, date of birth, UnitedHealthcare member ID
  • Current weight for dosing calculations
  • Confirmed MPS VII diagnosis with supporting lab results

Clinical Rationale:

  • Detailed description of MPS VII symptoms and progression
  • Treatment goals (symptom management, disease stabilization)
  • Expected clinical benefits based on FDA prescribing information

Supporting Evidence:

  • Enzyme activity test results showing β-glucuronidase deficiency
  • Genetic testing results (if available)
  • Urinary GAG levels
  • Specialist consultation notes

Required Attachments Checklist

  • Current laboratory results (enzyme activity, GAGs)
  • Genetic testing report (if performed)
  • Specialist consultation note
  • Patient's current weight documentation
  • Treatment plan including monitoring schedule
  • Infusion site verification letter
  • Prior authorization form (completed)

Submission Process

OptumRx Provider Portal Submission

  1. Access portal: Log into OptumRx Provider Portal using NPI credentials
  2. Select PA type: Choose "Medical Prior Authorization" for Mepsevii
  3. Complete required fields:
    • Patient demographics and UnitedHealthcare ID
    • Prescriber NPI and specialty credentials
    • Drug information (NDC, dose, frequency)
    • ICD-10 diagnosis code E76.29
  4. Upload documentation: Attach all required clinical documents
  5. Submit and record: Note confirmation number and submission date

Common Submission Errors to Avoid

  • Incomplete prescriber information - Ensure NPI and specialty are correctly entered
  • Missing weight documentation - Current weight required for dose calculation
  • Incorrect diagnosis code - Must use E76.29 for MPS VII
  • Unsigned clinical notes - All provider documentation must be signed and dated
Important: Incomplete submissions can delay processing by 5-10 business days while additional information is requested.

Specialty Pharmacy Requirements

UnitedHealthcare Network Requirements

Mepsevii is distributed exclusively through CuraScript SD for clinic and hospital pharmacies. Verify that CuraScript SD is in-network with your specific UnitedHealthcare plan before initiating therapy.

Infusion Site Requirements

Approved infusion locations:

  • Hospital outpatient infusion centers
  • Specialty infusion clinics
  • Home infusion (with qualified nursing support)

Required capabilities:

  • Emergency preparedness for anaphylaxis management
  • 4-hour infusion administration capability
  • Premedication protocols (antihistamines, antipyretics)

Patient Support Programs

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals aligned to UnitedHealthcare's own coverage rules.

Ultragenyx UltraCare Program provides:

  • Insurance coverage navigation
  • Copay assistance programs
  • Specialty pharmacy coordination
  • Prior authorization support

After Submission

Status Monitoring Schedule

  • Day 1-2: Verify submission confirmation number
  • Day 5: Check portal for any requests for additional information
  • Day 10: Follow up if no preliminary response received
  • Day 15: Escalate if no decision rendered

What to Record

For each submission, document:

  • Confirmation number and submission date
  • All documents included in original submission
  • Any follow-up requests and response dates
  • Contact names and reference numbers from phone calls

Approval Next Steps

Once approved:

  1. Verify specialty pharmacy assignment - Confirm CuraScript SD can fulfill
  2. Schedule infusion appointments - Coordinate with approved infusion center
  3. Confirm insurance benefits - Verify copay amounts and coverage limits
  4. Set up monitoring schedule - Plan for ongoing clinical assessments

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

1. Insufficient Diagnostic Documentation

  • Problem: Submitting without confirmatory enzyme or genetic testing
  • Solution: Include β-glucuronidase activity results or GUSB genetic testing

2. Non-Specialist Prescriber

  • Problem: Primary care or non-metabolic specialist prescribing
  • Solution: Ensure prescription comes from pediatric geneticist or metabolic specialist

3. Missing Weight-Based Dosing Justification

  • Problem: Requesting dose without current weight documentation
  • Solution: Include recent weight measurement and dose calculation

4. Incomplete Clinical Rationale

  • Problem: Generic letter without MPS VII-specific symptoms
  • Solution: Detail specific manifestations and treatment goals

5. Wrong Infusion Site

  • Problem: Requesting coverage for non-approved infusion locations
  • Solution: Verify infusion center meets UnitedHealthcare requirements

Virginia Appeals Process

Internal Appeals with UnitedHealthcare

Timeline: 180 days from denial date to file internal appeal

Required documentation:

  • Copy of original denial letter
  • Additional clinical evidence supporting medical necessity
  • Updated letter of medical necessity addressing denial reasons

Virginia External Review Process

If UnitedHealthcare upholds the denial after internal appeals, Virginia residents can request external review through the State Corporation Commission Bureau of Insurance.

Key requirements:

  • Form 216-A must be submitted within 120 days of final internal denial
  • Timeline: Independent review organization renders decision within 45 days
  • Expedited review: Available for urgent cases (72-hour decision)
  • Cost: No charge for external review in Virginia

Virginia Bureau of Insurance Contact:

  • Phone: 1-877-310-6560
  • Website: Bureau of Insurance Consumer Services
  • Form 216-A available through SCC website
From our advocates: "We've seen several MPS VII cases succeed at external review in Virginia when the original denial was based on 'experimental' determinations. The key was demonstrating FDA approval and providing peer-reviewed evidence of clinical benefit. Independent reviewers often have deeper expertise in rare diseases than initial payer reviewers."

Appeals through Counterforce Health leverage payer-specific workflows and produce letters that meet Virginia's procedural requirements while tracking deadlines and required documentation attachments.

Printable Checklist

Pre-Submission Checklist

Patient Information:

  • UnitedHealthcare member ID verified
  • Plan type confirmed (Commercial/Medicare/Medicaid)
  • Current patient weight documented
  • MPS VII diagnosis confirmed via enzyme or genetic testing

Clinical Documentation:

  • Specialist consultation note (geneticist or metabolic specialist)
  • β-glucuronidase enzyme activity results OR GUSB genetic testing
  • Urinary GAG levels (if available)
  • Treatment goals and monitoring plan documented
  • Infusion site capabilities verified

Coding and Billing:

  • ICD-10 code E76.29 confirmed
  • HCPCS code J3397 for billing
  • NDC 69794-0001-01 documented
  • Dose calculated as mg per kg body weight

Submission Requirements:

  • OptumRx Provider Portal access confirmed
  • All required fields completed
  • Supporting documents uploaded
  • Confirmation number recorded

Post-Submission:

  • Status check scheduled for day 5
  • Follow-up plan if additional information requested
  • Specialty pharmacy coordination confirmed
  • Appeal strategy prepared if denied

Disclaimer: This guide provides general information about UnitedHealthcare coverage requirements and Virginia appeal processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and verify current insurance requirements directly with UnitedHealthcare.

Sources & Further Reading

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