By Counterforce Health Team in Prolastin-C (alpha1-proteinase inhibitor) —

How to Get Prolastin-C Covered by Humana in Michigan: Prior Authorization Requirements and Appeal Process

Answer Box: Getting Prolastin-C Covered by Humana in Michigan

Prolastin-C requires prior authorization from Humana and is subject to step therapy requirements. You'll likely need to try a preferred alpha1-proteinase inhibitor first (like Zemaira) before Humana approves Prolastin-C. Key requirements: confirmed Pi*ZZ genotype, FEV1 ≤65% predicted, and non-smoking status. First step: Have your pulmonologist submit a prior authorization request through Humana's provider portal with complete documentation. If denied, you have 65 days to appeal and 127 days to request external review through Michigan DIFS.

Table of Contents

  1. Humana's Coverage Policy for Prolastin-C
  2. Medical Necessity Requirements
  3. Step Therapy and Preferred Alternatives
  4. Required Documentation and Diagnostics
  5. Prior Authorization Process
  6. Appeals Process for Michigan Residents
  7. Common Denial Reasons and Solutions
  8. Cost Considerations and Financial Assistance
  9. Frequently Asked Questions

Humana's Coverage Policy for Prolastin-C

Humana classifies Prolastin-C (alpha1-proteinase inhibitor) as a nonpreferred Part B drug requiring prior authorization. This means coverage falls under your medical benefit rather than prescription drug coverage, and you'll face additional hurdles compared to preferred alternatives.

Plan Types and Coverage

  • Medicare Advantage: Prolastin-C is covered under Part B with prior authorization
  • Commercial Plans: Coverage varies by specific plan design
  • Medicaid Plans: Follow similar prior authorization requirements

The medication is billed using HCPCS code J0256 and is typically administered in outpatient infusion centers or specialty clinics.

Medical Necessity Requirements

To meet Humana's medical necessity criteria for Prolastin-C, you must satisfy ALL of the following requirements:

Core Eligibility Criteria

Requirement Specific Details Documentation Needed
Age Must be 18 years or older Date of birth verification
Diagnosis Emphysema due to severe alpha1-antitrypsin deficiency ICD-10 codes, physician notes
AAT Level Pre-treatment serum AAT level <11 micromol/L Recent lab results
Genotype High-risk genotype (PiZZ, PiZNull, Pi*NullNull) Genetic testing results
Lung Function FEV1 of 65% predicted or less Pulmonary function tests
Smoking Status Current non-smoker or quit >3 months ago Provider attestation
Specialist Care Prescribed by or in consultation with pulmonologist Referral documentation

Supportive Therapy Requirements

Humana requires documentation that you're receiving appropriate supportive care, including:

  • Bronchodilator therapy
  • Oxygen therapy (if indicated)
  • Pulmonary rehabilitation (when appropriate)
  • Vaccinations (pneumococcal, influenza)

Step Therapy and Preferred Alternatives

Prolastin-C is not Humana's first-choice alpha1-proteinase inhibitor. The plan implements step therapy requirements, meaning you'll typically need to try a preferred alternative first.

Preferred Alternatives

While Humana considers all alpha1-proteinase inhibitors therapeutically equivalent, their formulary management may favor certain brands for cost reasons. Common alternatives include:

  • Zemaira (alpha1-proteinase inhibitor)
  • Aralast NP (alpha1-proteinase inhibitor)
  • Glassia (alpha1-proteinase inhibitor)

Step Therapy Exceptions

You can bypass step therapy if you can document:

  • Previous failure of preferred alternatives
  • Contraindication to preferred products
  • Intolerance to preferred alternatives
  • Drug interaction concerns
Tip: Work with your pulmonologist to document any previous trials of other alpha1-proteinase inhibitors, including specific reasons for discontinuation.

Required Documentation and Diagnostics

Laboratory Testing

Alpha1-Antitrypsin Testing Sequence:

  1. Serum AAT quantification (CPT 82103)
  2. AAT phenotyping (CPT 82104)
  3. Genetic testing for S and Z alleles

Michigan insurers, including Humana, typically cover genetic testing for alpha1-antitrypsin deficiency when clinical risk factors are present or when family history indicates potential deficiency.

Pulmonary Function Testing

Required Tests:

  • Spirometry with bronchodilator (pre- and post-bronchodilator values)
  • FEV1/FVC ratio <0.70 for COPD diagnosis
  • DLCO (diffusion capacity) to assess gas exchange impairment

Documentation Tips:

  • Tests should be performed within 6 months of prior authorization request
  • Include both absolute values and percent predicted
  • Note any reversibility with bronchodilators

Clinical Documentation

Your pulmonologist should provide comprehensive clinical notes including:

  • Symptom assessment (dyspnea, exercise tolerance, exacerbations)
  • Physical examination findings
  • Smoking history and current status
  • Previous treatments and responses
  • Treatment goals and monitoring plan

Prior Authorization Process

Step-by-Step Submission Process

  1. Provider Portal Submission
    • Your pulmonologist submits request through Humana's provider portal
    • Include all required documentation upfront
    • Expected timeline: 30 days for standard review
  2. Required Forms and Information
    • Completed prior authorization request form
    • Clinical notes supporting medical necessity
    • Laboratory results (AAT level, genotype)
    • Pulmonary function tests
    • Documentation of supportive therapies
  3. Review Process
    • Initial review by Humana's pharmacy team
    • Possible request for additional information
    • Peer-to-peer review if initial review is unfavorable

Authorization Periods

  • Initial authorization: 6 months
  • Reauthorization: 12 months with continued clinical benefit documentation

Appeals Process for Michigan Residents

If Humana denies your Prolastin-C request, Michigan residents have robust appeal rights through multiple levels.

Internal Appeals (Humana)

Timeline: 65 days from denial notice Process:

  • Submit appeal through Humana member portal or by mail
  • Include additional clinical documentation
  • Request expedited review if urgent (72 hours)

External Review (Michigan DIFS)

Timeline: 127 days after final internal denial Process:

  1. Complete Health Care Request for External Review form
  2. Submit supporting documentation
  3. Independent medical review by contracted organization
  4. Binding decision within 60 days (72 hours if expedited)

Michigan DIFS Contact:

  • Phone: 877-999-6442
  • Website: michigan.gov/difs
Note: Michigan's 127-day external review deadline is longer than the federal 120-day standard, giving you extra time to gather documentation.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy
Step therapy not completed Document previous trials of preferred alternatives or provide medical exception justification
Insufficient lung function documentation Submit recent PFTs showing FEV1 ≤65% predicted
Missing genotype confirmation Provide genetic testing results confirming high-risk genotype
Inadequate clinical notes Request comprehensive pulmonologist evaluation with treatment rationale
Non-preferred brand without justification Document contraindications or failures with preferred alternatives

Sample Medical Necessity Language

"Patient has confirmed severe alpha1-antitrypsin deficiency with PiZZ genotype and serum AAT level of 8.2 micromol/L. Despite optimal supportive therapy including bronchodilators and pulmonary rehabilitation, patient continues to experience progressive emphysema with FEV1 of 45% predicted. Previous trial of Zemaira resulted in infusion reactions requiring discontinuation. Prolastin-C is medically necessary to provide augmentation therapy and prevent further lung function decline."*

Cost Considerations and Financial Assistance

Annual Treatment Costs

Alpha1-proteinase inhibitor therapy is expensive, with annual costs commonly exceeding $80,000. Studies show average payer spending of approximately $127,000 per year for patients receiving augmentation therapy.

Financial Assistance Options

Grifols Patient Support Program:

  • Copay assistance for eligible patients
  • Prior authorization support services
  • Nursing support and education

Foundation Resources:

  • Alpha-1 Foundation patient assistance programs
  • HealthWell Foundation grants (when available)
  • Patient Access Network Foundation support

Frequently Asked Questions

How long does Humana's prior authorization process take? Standard prior authorization decisions are made within 30 days. Expedited reviews for urgent situations are completed within 72 hours.

What if Prolastin-C isn't on Humana's formulary? Prolastin-C is covered under Part B medical benefits rather than Part D prescription benefits. It requires prior authorization but can be covered with appropriate medical justification.

Can I request an expedited appeal in Michigan? Yes, both Humana internal appeals and Michigan DIFS external reviews offer expedited processes for urgent medical situations requiring physician documentation of medical urgency.

Does step therapy apply if I've tried other alpha1-proteinase inhibitors outside Michigan? Yes, document any previous trials of preferred alternatives regardless of where treatment occurred. Include medical records showing specific reasons for discontinuation.

What happens if my appeal is denied? After exhausting Humana's internal appeals, Michigan residents can request external review through DIFS. This independent medical review is binding on the insurer if decided in your favor.

How do I find a pulmonologist familiar with alpha1-antitrypsin deficiency? The Alpha-1 Foundation maintains a directory of healthcare providers experienced in AATD treatment. Specialist familiarity can be crucial for successful prior authorization requests.

About Counterforce Health: When insurance denials create barriers to necessary treatments like Prolastin-C, Counterforce Health helps patients and clinicians turn those denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to craft point-by-point rebuttals aligned with each payer's specific requirements, pulling the right clinical evidence and citations to support medical necessity arguments.

Throughout the prior authorization and appeals process, having expert support can make the difference between approval and continued denial. Counterforce Health specializes in navigating complex payer requirements for specialty medications, ensuring that clinical documentation meets the specific criteria insurers use to evaluate medical necessity.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Humana directly and consult with your healthcare provider about treatment decisions. For assistance with insurance appeals in Michigan, contact DIFS at 877-999-6442.

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