Coding That Helps Get Vimizim (Elosulfase Alfa) Approved by Humana in Texas: ICD-10, HCPCS, and Billing Guide
Answer Box: Getting Vimizim Covered by Humana in Texas
Primary requirement: Confirmed MPS IVA diagnosis with reduced GALNS enzyme activity or genetic testing. Fastest path: Use ICD-10 code E76.210, HCPCS J1322 for medical benefit billing, and submit comprehensive diagnostic documentation through Humana's provider portal. First step today: Gather enzyme activity results, genetic testing, and clinical notes; contact your specialist to initiate prior authorization with complete documentation package.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit Paths
- ICD-10 Mapping for MPS IVA
- Product Coding: HCPCS, J-Code, and NDC Overview
- Clean Request Anatomy
- Frequent Coding Pitfalls
- Verification with Humana Resources
- Quick Audit Checklist
- Appeals Process in Texas
- FAQ
Coding Basics: Medical vs. Pharmacy Benefit Paths
Vimizim (elosulfase alfa) can be billed through two pathways depending on your Humana plan structure and acquisition method:
Medical Benefit Path
- When to use: Physician-administered IV infusions in clinics, hospitals, or home settings
- Primary code: HCPCS J1322 (Injection, elosulfase alfa, 1 mg)
- Claim form: CMS-1500 (physician) or UB-04 (facility)
- Authorization: Always required before administration
Pharmacy Benefit Path
- When to use: Specialty pharmacy dispensing ("white bagging" or "brown bagging")
- Primary code: NDC 68135-500-01 (verify current NDC with Humana)
- Claim submission: Pharmacy claims system
- Authorization: Required prior to dispensing
Note: Most Humana plans prefer the medical benefit pathway for Vimizim due to the need for professional monitoring during infusion.
ICD-10 Mapping for MPS IVA
Accurate diagnosis coding is critical for Vimizim approval. Use these specific ICD-10 codes:
| ICD-10 Code | Description | When to Use |
|---|---|---|
| E76.210 | Morquio A mucopolysaccharidoses | Confirmed MPS IVA with GALNS deficiency |
| E76.211 | Morquio B mucopolysaccharidoses | MPS IVB (different enzyme deficiency) |
| E76.219 | Morquio mucopolysaccharidoses, unspecified | When subtype cannot be determined |
Documentation Requirements for E76.210
Your medical records must include:
- Laboratory confirmation: Reduced GALNS enzyme activity in fibroblasts or leukocytes
- Genetic testing: Biallelic pathogenic mutations in the GALNS gene
- Clinical manifestations: Skeletal abnormalities, respiratory issues, cardiac involvement
- Baseline assessments: 6-minute walk test, pulmonary function tests, urinary keratan sulfate levels
Tip: The more specific your diagnosis code (E76.210 vs. E76.219), the stronger your prior authorization request becomes.
Product Coding: HCPCS, J-Code, and NDC Overview
HCPCS J1322 Billing Details
- Unit definition: 1 billable unit = 1 mg of elosulfase alfa
- Dosing calculation: 2 mg/kg weekly
- Example: 70 kg patient = 140 mg = 140 units per infusion
- Annual units: ~7,280 units (140 units × 52 weeks)
NDC Information
- Primary NDC: 68135-500-01 (5 mg/5 mL single-use vial)
- Package size: Each vial contains 5 mg
- Units per vial: 5 billable units under J1322
- Storage requirements: Refrigerated; document proper handling
Administration Coding
When billing for infusion services, also include:
- CPT 96365: IV infusion, initial hour
- CPT 96366: Additional hours (Vimizim requires 3.5-4.5 hours)
- Modifier considerations: May be required based on site of care
Clean Request Anatomy
Here's what a complete prior authorization request should contain:
Patient Information Section
Patient: [Name, DOB, Humana ID]
Diagnosis: Morquio A syndrome (ICD-10: E76.210)
Prescriber: [Specialist name, NPI, contact]
Clinical Documentation
- Diagnostic confirmation
- GALNS enzyme activity results
- Genetic testing report
- Clinical assessment notes
- Treatment justification
- Current functional status
- Expected benefits from therapy
- Monitoring plan
- Billing information
- HCPCS J1322
- Calculated units based on weight
- Site of administration
- Frequency: Weekly
From our advocates: "We've seen the highest approval rates when the initial request includes both enzyme activity results AND genetic confirmation. Having both pieces of diagnostic evidence upfront prevents the common 'insufficient documentation' denial."
Frequent Coding Pitfalls
Unit Conversion Errors
- Common mistake: Billing vials instead of milligrams
- Correct approach: Always calculate total mg dose, then bill that number of J1322 units
- Example: 28 mg dose = 28 units of J1322 (not 6 vials)
Mismatched Benefit Categories
- Problem: Submitting J1322 to pharmacy benefit or NDC to medical benefit
- Solution: Verify benefit pathway with Humana before first submission
Missing Modifier Requirements
- Site-specific modifiers: May be required for home infusions
- Verify with Humana: Check current modifier requirements for your specific situation
Incomplete Prior Authorization
- Missing elements: Baseline functional assessments, specialist consultation
- Result: Automatic denial requiring resubmission
Verification with Humana Resources
Before submitting any claims or prior authorizations:
Check Current Formulary Status
- Visit Humana's drug list search
- Verify Vimizim's tier placement
- Confirm prior authorization requirements
Validate Coding Requirements
- Provider portal: Access current billing guidelines
- Customer service: 1-800-448-6262 for provider inquiries
- Policy documents: Search for elosulfase alfa or Vimizim-specific policies
Confirm Site of Care Preferences
Some Humana plans have specific requirements about:
- Approved infusion centers
- Home health agency credentials
- Monitoring protocols
Quick Audit Checklist
Before submitting your prior authorization or claim:
Diagnosis Coding
- Used E76.210 for confirmed MPS IVA
- Supporting lab/genetic documentation attached
- Clinical notes include baseline assessments
Product Coding
- J1322 units calculated correctly (mg = units)
- NDC verified if using pharmacy benefit
- Administration codes included if applicable
Documentation
- Specialist prescriber with appropriate credentials
- Medical necessity clearly stated
- Monitoring plan detailed
- Prior therapy history documented
Submission Details
- Correct benefit pathway (medical vs. pharmacy)
- All required forms completed
- Contact information current
Appeals Process in Texas
If your initial prior authorization is denied, Texas provides strong appeal rights:
Internal Appeal Timeline
- Deadline: 65 days from denial notice
- Humana review: 7 days standard, 24-72 hours expedited
- Required: Point-by-point response to denial reasons
External Review Rights
Texas law provides Independent Review Organization (IRO) appeals when:
- Internal appeal is denied
- Denial is based on medical necessity
- Request filed within 4 months of final denial
Expedited Appeals
Available when delay could jeopardize health:
- Timeline: 5 days for urgent cases
- Requirements: Physician attestation of urgency
- Scope: Both internal and external reviews can be expedited
Note: For assistance with appeals in Texas, contact the Texas Department of Insurance at 1-800-252-3439 or the Office of Public Insurance Counsel at 1-877-611-6742.
At Counterforce Health, we specialize in turning insurance denials into targeted, evidence-backed appeals. Our platform helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting point-by-point rebuttals aligned to each payer's specific policies.
FAQ
How long does Humana prior authorization take for Vimizim in Texas? Standard review takes 7-15 business days. Expedited review (when medical urgency is documented) can be completed within 24-72 hours.
What if Vimizim is not on my Humana formulary? Request a formulary exception through your prescriber. You'll need documentation showing why all formulary alternatives are ineffective or contraindicated. Timeline is 72 hours standard, 24 hours expedited.
Can I appeal if my initial authorization is denied? Yes. You have 65 days to file an internal appeal with Humana. If that's denied, Texas law provides external review through an Independent Review Organization within 4 months.
Does step therapy apply to Vimizim? Generally no, because there are no alternative disease-modifying therapies for MPS IVA. However, Humana may request documentation of supportive care measures.
What's the difference between J1322 and NDC billing? J1322 is used when billing through the medical benefit (physician-administered). NDC is used when billing through the pharmacy benefit (specialty pharmacy dispensed).
Who can prescribe Vimizim for Humana coverage? Must be prescribed by a specialist familiar with MPS, such as a biochemical geneticist, metabolic disease physician, or other qualified specialist.
What baseline tests are required for approval? GALNS enzyme activity testing, genetic confirmation, baseline functional assessments (6-minute walk test), pulmonary function tests, and urinary keratan sulfate levels.
How often do I need reauthorization? Initial approval is typically for 6 months. Renewal requires documentation of clinical response, stability, or improvement in functional measures.
Sources & Further Reading
- Humana Provider Portal - Drug Lists
- Texas Department of Insurance - Appeals Guide
- CMS Medicare Appeals Process
- Humana Member Exceptions and Appeals
- VIMIZIM Prescribing Information (FDA)
- ICD-10 Code Lookup - E76.210
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional support with insurance appeals in Texas, consider contacting Counterforce Health or the Texas Department of Insurance consumer helpline at 1-800-252-3439.
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