By Counterforce Health Team in Myozyme (alglucosidase alfa) —

How to Get Myozyme (Alglucosidase Alfa) Covered by Humana in Ohio: Complete Forms, Appeals & Timeline Guide

Answer Box: Getting Myozyme Covered by Humana in Ohio

Humana requires prior authorization for Myozyme (alglucosidase alfa) across all Ohio plans. To get coverage: 1) Have your doctor submit a PA request via Humana's provider portal with confirmed Pompe disease diagnosis (genetic testing + enzyme activity), 2) Include medical necessity documentation showing functional impairment and specialist evaluation, 3) If denied, file internal appeal within 60 days, then Ohio external review within 180 days through the Ohio Department of Insurance. Start today: Verify your specific plan's PA requirements using Humana's search tool.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Forms and Documentation
  4. Submission Portals and Methods
  5. Specialty Pharmacy Enrollment
  6. Appeals Process for Ohio Residents
  7. Common Denial Reasons & Solutions
  8. Cost Assistance and Support
  9. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana plans PA Search Tool Humana Provider Portal
Formulary Status Specialty tier, non-formulary possible Drug Lists Humana Formulary
Diagnosis Required Pompe disease (ICD-10: E74.02) Medical records FDA Label
Specialist Evaluation Neurologist or metabolic specialist Referral documentation Payer Policy
Dosing 20 mg/kg every 2 weeks IV Prescription FDA Access Data
Site of Care Experienced infusion center Treatment plan FDA Safety Info

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan Requirements

Who: Patient or clinic staff
Document: Insurance card, member ID
How: Use Humana's PA search tool
Timeline: Same day

2. Gather Diagnostic Documentation

Who: Prescribing physician
Documents: Genetic testing (two pathogenic GAA variants), enzyme activity test (GAA <1% normal for infantile, <40% for late-onset)
Timeline: May take 2-4 weeks if tests needed

3. Complete Medical Necessity Assessment

Who: Specialist (neurologist/metabolic)
Documents: Functional assessments (6-minute walk test, pulmonary function tests), muscle weakness documentation
Timeline: 1-2 weeks for comprehensive evaluation

4. Submit Prior Authorization

Who: Prescriber or clinic staff
How: Electronic submission via provider portal (preferred) or fax
Timeline: Processed within 1 business day for specialty drugs

5. Monitor and Follow Up

Who: Patient and clinic
How: Check portal status or call member services
Timeline: Standard decisions within 15 days, expedited within 72 hours

Required Forms and Documentation

Core Prior Authorization Requirements

Diagnosis Confirmation:

  • Genetic testing results showing two pathogenic GAA gene variants
  • Enzyme activity testing (acid alpha-glucosidase <1% of normal for infantile-onset, <40% for late-onset)
  • ICD-10 code E74.02 (Pompe disease)

Clinical Evidence:

  • Functional impairment documentation (muscle weakness, respiratory dysfunction)
  • Pulmonary function tests showing restrictive pattern
  • 6-minute walk test results (if applicable)
  • Evidence of disease progression

Medical Necessity Letter Checklist

Your specialist should include:

  • Problem Statement: Confirmed Pompe disease diagnosis with genetic/enzyme evidence
  • Prior Treatments: Document any previous therapies and their outcomes
  • Clinical Rationale: Why Myozyme is medically necessary at FDA-labeled dosing
  • Safety Considerations: Plan for infusion at experienced center due to anaphylaxis risk
  • Monitoring Plan: How treatment response will be measured
Clinician Corner: The medical necessity letter is crucial. Include specific functional decline metrics, cite FDA labeling for dosing rationale, and emphasize the need for specialized infusion facilities. Counterforce Health can help draft targeted appeal letters that address payer-specific criteria.

Submission Portals and Methods

Electronic Submission (Preferred)

  • Provider Portal: provider.humana.com
  • Processing Time: 1 business day for most specialty drugs
  • Required Account: Humana provider registration

Alternative Submission Methods

  • Pharmacy PA Fax: 1-855-681-8650
  • CoverMyMeds: For pharmacy submissions
  • Phone Support: Call member services number on insurance card

Required Documentation Upload

  • Complete medical records
  • Genetic and enzyme testing results
  • Specialist evaluation notes
  • Functional assessment results
  • Previous treatment history

Specialty Pharmacy Enrollment

CenterWell Specialty Pharmacy Process

Patient Steps:

  1. Log into MyHumana portal or CenterWell account
  2. Start new prescription request or manage existing therapy
  3. Coordinate with clinical team for insurance verification

Provider Actions:

  1. E-prescribe to CenterWell Specialty Pharmacy
  2. Fax prescription to 1-877-405-7940
  3. Call 1-800-486-2668 to initiate enrollment

Services Included:

  • Insurance coordination and benefits verification
  • Financial assistance program applications
  • Clinical support and monitoring
  • Secure home delivery with expedited shipping
  • Unmarked packaging for privacy

Appeals Process for Ohio Residents

Internal Appeals with Humana

Standard Appeal:

  • Deadline: 60 days from denial notice
  • Submission: Online via member portal or mail
  • Timeline: Decision within 30 days (Medicare Advantage), 15 days (commercial)

Expedited Appeal:

  • When to Use: If delay would seriously jeopardize health
  • Timeline: Decision within 72 hours
  • How to Request: Call member services, emphasize urgency

Ohio External Review Process

After exhausting Humana's internal appeals, Ohio residents can request external review:

Eligibility: Denials involving medical judgment or medical necessity
Deadline: 180 days from final internal denial
How to File: Through Ohio Department of Insurance External Review System
Contact: [email protected] or (614) 644-0188

Process:

  1. Submit request via online system (OH|ID login required)
  2. Independent Review Organization (IRO) assigned
  3. Medical experts review case
  4. Decision within 30 days (standard) or 72 hours (expedited)
  5. Decision is binding on Humana
Note: Self-funded employer plans follow federal ERISA rules, not Ohio's external review process. However, many voluntarily use similar procedures.

Common Denial Reasons & Solutions

Denial Code/Reason How to Overturn Required Documentation
PA001: No prior authorization Submit PA immediately Complete PA form with all clinical docs
MEDNE: Not medically necessary Address criteria gaps Enhanced medical necessity letter, specialist evaluation
NFORM: Non-formulary Request formulary exception Demonstrate why formulary alternatives are inappropriate
STEP: Step therapy not met Document alternative failures Previous treatment records, intolerance documentation
DIAG: Diagnosis not confirmed Provide genetic/enzyme testing Complete diagnostic workup results
DOSE: Dosing outside guidelines Justify FDA-labeled dosing Cite FDA prescribing information, weight-based calculations

When to Request Peer-to-Peer Review

If your initial PA is denied, request a peer-to-peer review where your specialist speaks directly with Humana's medical director. This often resolves complex cases faster than written appeals.

Cost Assistance and Support

Manufacturer Support Programs

Sanofi Patient Assistance: Contact Sanofi directly for copay assistance and patient support programs (verify current programs on manufacturer website)

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • Patient Access Network (PAN) Foundation
  • HealthWell Foundation

Ohio-Specific Resources

  • UHCAN Ohio: Universal Health Care Action Network provides consumer assistance
  • Ohio Department of Insurance Consumer Services: 1-800-686-1526
  • OSHIIP: Ohio Senior Health Insurance Information Program (for Medicare issues)
From Our Advocates: One family successfully overturned a "not medically necessary" denial by having their neurologist emphasize the progressive nature of Pompe disease and include before/after pulmonary function tests showing decline. The peer-to-peer review with specific functional data made the difference.

FAQ

Q: How long does Humana's prior authorization take in Ohio?
A: Electronic submissions through the provider portal typically process within 1 business day for specialty drugs. Standard decisions come within 15-30 days depending on your plan type.

Q: What if Myozyme is non-formulary on my Humana plan?
A: Request a formulary exception by demonstrating that covered alternatives are ineffective or cause adverse effects. Include a detailed medical necessity letter from your specialist.

Q: Can I get an expedited appeal if denied?
A: Yes, if a delay would seriously jeopardize your health. Call member services immediately and emphasize the urgent medical need. Expedited appeals receive decisions within 72 hours.

Q: Does step therapy apply if I've failed treatments outside of Ohio?
A: Yes, previous treatment failures from any location should count toward step therapy requirements. Ensure your medical records clearly document these trials and outcomes.

Q: What happens if Ohio's external review upholds the denial?
A: The external review decision is binding on Humana. However, you retain rights to pursue other remedies such as regulatory complaints or legal action if appropriate.

Q: How much does Myozyme cost without insurance?
A: Cash pricing is approximately $1,026 per 50-mg vial. Given the typical dosing of 20 mg/kg every 2 weeks, monthly costs can be substantial, making insurance coverage essential.

Ohio-Specific Consumer Resources

Ohio Department of Insurance

  • Consumer Hotline: 1-800-686-1526
  • External Review: [email protected]
  • Website: insurance.ohio.gov

UHCAN Ohio

  • Consumer assistance with health insurance appeals
  • Website: uhcanohio.org

Ohio Medicaid Appeals

  • State fair hearings for Medicaid denials
  • Contact Ohio Department of Medicaid

Staying Current with Requirements

Humana updates its prior authorization requirements and formulary lists regularly. Check these resources quarterly or before each treatment cycle:

Counterforce Health helps patients and clinicians navigate complex insurance appeals by analyzing denial letters and crafting targeted responses that address payer-specific criteria. Our platform turns insurance denials into evidence-backed appeals that speak directly to each plan's requirements.

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 circumstances and plan specifics. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with Ohio insurance regulations, contact the Ohio Department of Insurance at 1-800-686-1526.

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