Getting Prolastin-C Covered by Blue Cross Blue Shield of Michigan: PA Requirements, Appeals, and State Protections (2024-2025)

Answer Box: How to Get Prolastin-C Covered by BCBS Michigan

Blue Cross Blue Shield of Michigan requires prior authorization for Prolastin-C (alpha1-proteinase inhibitor) for commercial members, with specific criteria including confirmed alpha-1 antitrypsin deficiency, nonsmoker status, and symptomatic emphysema. Medicare Plus Blue and BCN Advantage members don't need PA as of January 2024.

Fastest path to approval:

  1. Submit PA request via BCBSM provider portal with complete clinical documentation
  2. If denied, file internal appeal within plan deadlines
  3. Request external review with Michigan DIFS within 127 days if needed

Start today: Gather your AAT lab results, pulmonary function tests, smoking cessation documentation, and prior therapy records.


Table of Contents


Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for commercial BCBS/BCN plans Provider portal or forms BCBSM PA Guidelines
Age Requirement FDA-approved age for therapy Product labeling FDA prescribing information
AAT Deficiency Diagnosis Confirmed low serum AAT levels Lab results required BCBSM medical policy
Nonsmoker Status Current nonsmoker verification Provider attestation BCBSM PA criteria
Emphysema Documentation Symptomatic with deteriorating function PFTs, imaging, clinical notes Medical policy requirements
Medicare Exception No PA needed for Medicare Plus Blue/BCN Advantage Plan documents Coverage Update

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan Type

  • Who: Patient or clinic staff
  • Document needed: Insurance card showing BCBS Michigan or BCN
  • Action: Check if you have Medicare Plus Blue or BCN Advantage (no PA required)
  • Timeline: 5 minutes
  • Source: Plan identification guide

2. Gather Required Clinical Documentation

  • Who: Healthcare provider
  • Documents needed:
    • AAT lab results showing deficiency
    • Pulmonary function tests
    • Smoking cessation documentation
    • Clinical notes documenting emphysema symptoms
  • Timeline: 1-2 business days
  • Source: BCBSM medical policy requirements

3. Submit Prior Authorization Request

  • Who: Healthcare provider
  • Method: BCBSM provider portal (availity.com) using "Medical/Pharm Drug Benefit Prior Auth (Commercial) tile"
  • Documents: Complete PA form with all clinical documentation
  • Timeline: Submit within 1 business day of gathering documents
  • Source: Provider portal instructions

4. Track Decision Timeline

  • Who: Patient and provider
  • Standard timeline: Up to 15 calendar days for non-urgent requests
  • Expedited: 72 hours for urgent medical needs
  • Action: Follow up if no response within standard timeframes

5. Prepare for Potential Denial

  • Who: Patient with provider support
  • Documents to gather: All original submission materials plus any additional clinical evidence
  • Timeline: Begin immediately upon denial notice
  • Next step: Internal appeal process

Understanding Michigan's Prior Authorization Laws

Michigan's healthcare landscape provides specific protections for patients dealing with prior authorization denials, particularly for expensive specialty medications like Prolastin-C.

How State Rules Interact with BCBS Policies

Michigan law requires health insurers, including BCBS Michigan, to maintain transparent prior authorization processes and provide clear appeal pathways. While BCBS sets its own medical necessity criteria, these must comply with Michigan's patient protection standards under the Patient's Right to Independent Review Act.

Turnaround Standards

Standard Requests:

  • Non-urgent: 15 calendar days maximum
  • Urgent: 72 hours when physician certifies medical urgency
  • Renewal requests: Must be processed before current authorization expires

Business vs. Calendar Days: Michigan regulations specify calendar days for most healthcare decisions, meaning weekends and holidays count toward insurer response deadlines.


Step Therapy Protections and Medical Exceptions

BCBS Michigan may require step therapy for alpha-1 antitrypsin augmentation therapy, but Michigan law provides clear pathways for medical exceptions.

Medical Exception Criteria

You can request a step therapy override if:

  • Previous therapy failure: You've tried and failed preferred treatments
  • Contraindication: Medical reasons prevent use of preferred drugs
  • Adverse reaction: You've experienced intolerance to required first-line therapies
  • Unique clinical circumstances: Rare disease factors make step therapy inappropriate

Documentation That Helps

When requesting exceptions, include:

  • Specific adverse reactions experienced with previous treatments
  • Clinical contraindications with supporting literature
  • Timeline of previous therapy attempts and outcomes
  • Specialist recommendation for Prolastin-C specifically
From our advocates: We've seen successful step therapy overrides when providers document not just that a patient "failed" previous therapy, but specifically how—whether through inadequate response measured by lung function tests, intolerable side effects, or contraindications based on comorbid conditions. The more specific the clinical narrative, the stronger the exception request.

Continuity of Care During Transitions

Ongoing Therapy Protections

Michigan's continuity of care laws protect patients already receiving Prolastin-C when transitioning between plans or providers. Under the Patient's Right to Independent Review Act, BCBS Michigan must consider:

  • Medical necessity of continuing current therapy
  • Risk of treatment interruption
  • Provider recommendations for continuity

Grace Periods and Transition Coverage

When switching to BCBS Michigan from another insurer:

  1. Notify BCBS immediately about ongoing Prolastin-C therapy
  2. Request temporary coverage while PA is processed
  3. Provide documentation from previous insurer showing approval
  4. Submit full PA application within plan deadlines

For patients moving within Michigan or temporarily out of state, BCBS participates in the BlueCard network, which can facilitate continuity of specialty care.


Appeals Playbook for BCBS Michigan

Internal Appeal Process

Level 1: Standard Internal Appeal

  • Deadline: 180 days from denial notice for commercial plans
  • How to file: Written request to BCBS member services
  • Timeline: 30 calendar days for decision
  • Required documents: Original denial letter, additional clinical evidence

Level 2: Expedited Internal Appeal

  • When to use: When delay would seriously jeopardize health
  • Timeline: 72 hours for decision
  • Required: Physician certification of urgency

External Review with Michigan DIFS

If BCBS upholds the denial after internal appeals:

Standard External Review:

Expedited External Review:

  • Timeline: 72 hours for decision
  • Required: Physician letter certifying medical urgency
  • Contact: DIFS at 877-999-6442
Note: External review decisions are binding on BCBS Michigan. If the Independent Review Organization approves coverage, BCBS must comply.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Provide comprehensive clinical evidence Updated PFTs, exacerbation history, specialist letter
"Experimental/investigational" Cite FDA approval and guidelines FDA labeling, medical society recommendations
"Step therapy not completed" Request medical exception Prior therapy failure documentation
"Non-preferred brand" Formulary exception request Clinical rationale for Prolastin-C specifically
"Insufficient documentation" Submit complete clinical record All required elements per PA criteria
"Age restrictions" Verify FDA-approved indication Prescribing information, clinical justification

When to Escalate to State Regulators

Contact Michigan DIFS if BCBS:

  • Fails to respond within required timeframes
  • Denies external review improperly
  • Doesn't implement approved coverage decisions
  • Creates administrative barriers to care

Michigan DIFS Contact Information:

  • Phone: 877-999-6442 (M-F, 8 AM-5 PM)
  • Website: Michigan.gov/DIFS
  • External Review: Online form or mail/fax submission

When filing a complaint, include:

  • All correspondence with BCBS
  • Denial letters and appeal decisions
  • Medical documentation
  • Timeline of events

Cost Assistance and Patient Support

Manufacturer Support Programs

Grifols, the manufacturer of Prolastin-C, may offer:

  • Patient assistance programs for eligible uninsured patients
  • Copay assistance for commercially insured patients
  • Case management support for prior authorization

Contact Grifols directly for current program availability and eligibility requirements.

Foundation Grants and State Programs

Michigan residents may qualify for:

  • Alpha-1 Foundation patient assistance
  • Michigan Department of Health rare disease programs
  • Charitable foundations supporting respiratory conditions

Healthcare Coverage Assistance

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines while tracking deadlines and procedural requirements.


FAQ

Q: How long does BCBS Michigan prior authorization take for Prolastin-C? A: Standard PA requests receive decisions within 15 calendar days. Expedited requests for urgent medical needs are processed within 72 hours.

Q: What if Prolastin-C is not on my BCBS formulary? A: You can request a formulary exception by providing clinical justification for why Prolastin-C is medically necessary compared to covered alternatives.

Q: Can I request an expedited appeal if my Prolastin-C is denied? A: Yes, if your physician certifies that delaying treatment would seriously jeopardize your health. Expedited appeals receive decisions within 72 hours.

Q: Does step therapy apply if I've already been on Prolastin-C with another insurer? A: Michigan's continuity of care protections may allow you to continue current therapy while transitioning. Request temporary coverage and provide documentation of previous approval.

Q: What happens if BCBS denies my external review with Michigan DIFS? A: External review decisions are binding on insurers. If DIFS approves coverage, BCBS must comply. If denied, you may appeal to Michigan circuit court within 60 days.

Q: Are there different requirements for Medicare members? A: Yes. Medicare Plus Blue and BCN Advantage members don't need prior authorization for Prolastin-C as of January 2024. Traditional Medicare coverage follows CMS guidelines.

Q: How can I find patient assistance programs for Prolastin-C? A: Contact Grifols directly, check with the Alpha-1 Foundation, and ask your healthcare team about available support programs.

Q: What should I do if BCBS doesn't respond to my appeal within the required timeframe? A: Contact Michigan DIFS at 877-999-6442 to file a complaint about delayed processing and request assistance with your case.


Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with insurance appeals and prior authorization challenges, Counterforce Health provides specialized support for patients and providers navigating complex coverage decisions.

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