By Counterforce Health Team in Arikayce (amikacin liposome inhalation) —

Get Arikayce Covered by Blue Cross Blue Shield Michigan: Prior Authorization Forms, Appeals, and State Review Process

Quick Answer: Arikayce requires prior authorization from Blue Cross Blue Shield of Michigan, typically with step therapy requirements. Start by having your doctor submit a PA request with documentation of refractory MAC lung disease and failed standard therapies. If denied, you have 127 days to file an external review with Michigan DIFS. For urgent cases, expedited appeals are decided within 72 hours with a physician letter.

Table of Contents

Why Michigan State Rules Matter

Michigan's insurance regulations provide important consumer protections that work alongside Blue Cross Blue Shield of Michigan's (BCBSM) internal policies. Understanding these state-level rules can make the difference between a quick approval and months of appeals.

Key Michigan protections include:

  • 127-day window to file external reviews with the Department of Insurance and Financial Services (DIFS)
  • 72-hour expedited appeals for urgent medical situations
  • Required response timelines for prior authorization requests
  • Independent medical review through contracted organizations

These protections apply to most commercial BCBSM plans, though self-funded employer plans may have different rules under federal ERISA law.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Arikayce prescriptions BCBSM formulary documents BCBSM Prior Auth Guidelines
Step Therapy Must try preferred MAC therapies first Same formulary document BCBSM Guidelines
Medical Necessity Documentation of refractory MAC lung disease Provider submission FDA Label
Appeals Deadline 127 days for external review Michigan PRIRA DIFS Appeals Process
Expedited Review 72 hours with physician letter DIFS expedited process DIFS External Review

Step-by-Step: Fastest Path to Approval

1. Verify Current Coverage Status (Patient/Clinic)

  • Call BCBSM member services at the number on your insurance card
  • Ask specifically about Arikayce formulary status and PA requirements
  • Request the current prior authorization form

2. Gather Required Documentation (Clinic)

  • Diagnosis confirmation with ICD-10 codes for MAC lung disease
  • Documentation of ≥6 months of standard combination therapy
  • Culture results showing persistent infection
  • Audiometry results (baseline hearing assessment)

3. Submit Prior Authorization Request (Prescriber)

  • Complete BCBSM prior authorization form with detailed clinical rationale
  • Include all supporting documentation
  • Submit via BCBSM provider portal or fax (verify current submission method)
  • Timeline: Standard decisions within 5-7 business days

4. Request Step Therapy Exception (if needed) (Prescriber)

  • Document why standard MAC therapies were ineffective or contraindicated
  • Include specific adverse events or treatment failures
  • Cite clinical guidelines supporting Arikayce use

5. Follow Up on Decision (Patient/Clinic)

  • Check status through provider portal
  • If approved, coordinate with specialty pharmacy
  • If denied, immediately begin appeal process

6. File Internal Appeal (if denied) (Patient/Representative)

  • Submit within timeframe specified in denial letter
  • Include additional clinical documentation
  • Timeline: Decision typically within 15-30 days

7. Prepare External Review (if needed) (Patient)

  • File with Michigan DIFS within 127 days of final denial
  • Include physician letter for expedited review if urgent
  • Timeline: Standard review within 60 days, expedited within 72 hours

Prior Authorization Turnaround Standards

Blue Cross Blue Shield of Michigan follows specific timelines for prior authorization decisions:

Standard Requests:

  • Non-urgent: 5-7 business days from receipt of complete information
  • Additional information needed: BCBSM will request within 2 business days

Expedited Requests:

  • Urgent medical situations: 24-48 hours
  • Requires physician attestation of urgency
  • Must demonstrate potential harm from delay

Renewal Timelines:

  • Ongoing therapy reviews typically occur annually
  • BCBSM may require updated clinical documentation
  • Submit renewal requests 30 days before current authorization expires
Tip: Always confirm receipt of your PA submission and ask for a reference number to track your request.

Step Therapy Protections in Michigan

While Michigan hasn't enacted comprehensive step therapy override laws, you can still request exceptions based on medical necessity. BCBSM may grant step therapy exceptions when:

Valid Exception Criteria:

  • Previous treatment with required medications resulted in adverse effects
  • Required medications are contraindicated due to drug interactions or allergies
  • Patient has tried and failed required therapies in the past
  • Required medications are expected to be ineffective based on clinical factors
  • Patient is stable on current non-preferred therapy

Documentation Phrases That Help:

  • "Patient experienced significant adverse effects including..."
  • "Standard MAC therapy regimen failed to achieve culture conversion after 6 months"
  • "Contraindicated due to documented drug interaction with..."
  • "Clinical guidelines support Arikayce as appropriate next-line therapy"

Clinician Corner: Medical Necessity Documentation

When submitting prior authorization requests for Arikayce, include these essential elements:

Required Clinical Information:

  • Diagnosis: Confirmed MAC lung disease with appropriate ICD-10 codes
  • Treatment History: Detailed record of ≥6 months standard combination therapy
  • Culture Results: Documentation of persistent positive cultures
  • Functional Status: Impact on patient's respiratory function and quality of life
  • Monitoring Plan: Audiometry schedule and safety monitoring protocols

Supporting Evidence to Include:

  • FDA-approved labeling for refractory MAC lung disease
  • Relevant ATS/IDSA guidelines for NTM treatment
  • Patient-specific factors supporting Arikayce use

Sample Medical Necessity Statement: "Patient has refractory MAC lung disease with persistent positive cultures despite 8 months of guideline-directed combination therapy including azithromycin, ethambutol, and rifampin. Standard therapy has failed to achieve culture conversion, and patient continues to experience progressive respiratory symptoms. Arikayce is FDA-approved for this specific indication and represents the appropriate next step in treatment per current clinical guidelines."

Appeals Playbook for BCBS Michigan

Understanding the appeal process can significantly improve your chances of overturning a denial.

Internal Appeals Process

Level 1 - Standard Internal Appeal

  • Deadline: Varies by plan (typically 180 days from denial)
  • Timeline: 15-30 days for decision
  • How to file: Online portal, phone, or mail
  • Required: Copy of denial letter, additional clinical documentation

Level 2 - Internal Appeal Review

  • Automatic: If Level 1 is denied
  • Timeline: 15-30 days for decision
  • Review: Conducted by different clinical reviewers

External Review Options

Standard External Review

  • When: After exhausting internal appeals
  • Deadline: 127 days from final internal denial
  • Timeline: Up to 60 days for decision
  • Cost: Free to patient

Expedited External Review

  • When: Urgent medical situations
  • Deadline: 10 days from final denial to qualify for expedited processing
  • Timeline: 72 hours for decision
  • Requirement: Physician letter documenting urgency

External Review & DIFS Complaints

Michigan's Department of Insurance and Financial Services (DIFS) provides independent review when insurers deny coverage.

How to File with DIFS:

  1. Online: DIFS External Review Portal
  2. Phone: 877-999-6442 (Monday-Friday, 8 AM-5 PM)
  3. Mail: DIFS Appeals Section, PO Box 30220, Lansing, MI 48909-7720
  4. Email: [email protected]

Required Documentation:

  • Final denial letter from BCBSM
  • Your insurance policy information
  • Medical records supporting the request
  • Physician letter of medical necessity
  • For expedited review: physician letter documenting urgency

What Happens Next:

  • DIFS reviews your submission for completeness
  • If eligible, case is assigned to an Independent Review Organization (IRO)
  • IRO conducts medical review with appropriate specialists
  • Decision is binding on the insurance company
Note: DIFS has issued nearly 1,000 orders to health insurance companies since 2019, demonstrating active enforcement of consumer protections.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not meeting 6-month refractory criterion" Provide detailed treatment timeline Culture results, prescription records, clinical notes showing ≥6 months therapy
"Off-label use" Cite FDA approval for MAC lung disease FDA label, clinical guidelines
"Lack of combination regimen" Document current background therapy Current prescriptions for azithromycin/clarithromycin + ethambutol + rifamycin
"Monitoring gaps" Establish audiometry plan Baseline audiogram, scheduled follow-up appointments
"Step therapy not completed" Request medical exception Document failures/contraindications to required therapies

Scripts for Calling BCBS Michigan

When calling about prior authorization status: "I'm calling to check on the status of a prior authorization request for Arikayce, generic name amikacin liposome inhalation suspension. The request was submitted on [date] by Dr. [name]. Can you provide the current status and any additional information needed?"

When requesting expedited review: "I need to request an expedited prior authorization review for Arikayce. My physician has documented that this is medically urgent and any delay could harm my health. What is the process for submitting an expedited request?"

When appealing a denial: "I received a denial for Arikayce and would like to file an appeal. Can you please provide me with the appeal form and explain the deadline for submission? I have additional clinical documentation that wasn't included in the original request."

FAQ

How long does BCBS Michigan prior authorization take for Arikayce? Standard requests are typically processed within 5-7 business days. Expedited requests for urgent medical situations are processed within 24-48 hours.

What if Arikayce isn't on the BCBS Michigan formulary? You can request a formulary exception with supporting documentation from your physician. BCBSM must respond within 72 hours of receiving a complete request.

Can I get an expedited appeal in Michigan? Yes, Michigan offers expedited external reviews through DIFS for urgent medical situations. The decision is made within 72 hours and requires a physician letter documenting the urgency.

Does step therapy apply if I tried these medications outside Michigan? Previous treatment history from other states should be accepted as long as you have proper documentation. Include all medical records showing prior therapy attempts.

What happens if DIFS overturns the denial? DIFS decisions are binding. If the external review finds in your favor, BCBSM must provide coverage as directed by the independent medical reviewers.

How much does Arikayce cost without insurance? Cash prices for Arikayce vials range from approximately $1,500-$1,600 per 590 mg dose. Monthly costs can exceed $45,000 without coverage.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create compelling appeals that align with each insurer's specific requirements, significantly improving approval rates for complex medications like Arikayce.

For additional support navigating insurance appeals, Counterforce Health provides comprehensive tools and expertise to help patients access the medications they need.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always consult with your healthcare provider and insurance company for the most current information regarding coverage decisions. For questions about Michigan insurance regulations, contact DIFS at 877-999-6442.

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