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

How to Get Arikayce Covered by Cigna in Ohio: Complete Prior Authorization and Appeal Guide

Answer Box: Getting Arikayce Covered by Cigna in Ohio

Cigna requires prior authorization for Arikayce (amikacin liposome inhalation) with specific criteria: refractory MAC lung disease after ≥6 months of combination therapy, amikacin-susceptible cultures, and specialist oversight. First step: Gather baseline audiogram, culture results, and documentation of failed standard therapy. Submit PA through Cigna provider portal or call member services. If denied, Ohio residents have 180 days to appeal internally, then request external review through the Ohio Department of Insurance. Success rate improves significantly with peer-to-peer reviews and complete clinical documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Cigna plans Cigna PA Policy
Age Requirement ≥18 years for MAC indication FDA label, Cigna criteria
Background Therapy ≥6 months of macrolide + ethambutol + rifamycin Cigna Medicare PA Grid
Culture Status Persistently positive MAC cultures Clinical documentation required
Specialist Requirement Pulmonologist or ID specialist Cigna policy requirement
Monitoring Baseline and serial audiograms FDA safety requirement

Getting Arikayce (amikacin liposome inhalation) approved by Cigna in Ohio requires understanding both the clinical criteria and the appeals process. With MAC lung disease affecting thousands of Americans and Arikayce costing approximately $1,500 per vial, prior authorization denials are common—but overturnable with the right approach.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules.

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility (Patient/Clinic)

  • Document: Confirmed MAC lung disease diagnosis with positive cultures
  • Timeline: Before prescribing
  • Submit via: Clinical assessment and lab review

2. Gather Required Documentation (Clinic Staff)

  • Document: Baseline audiogram, culture/susceptibility results, prior therapy records
  • Timeline: 1-2 weeks before PA submission
  • Submit via: Coordinate with audiology, lab, and pharmacy records

3. Submit Prior Authorization (Prescriber)

  • Document: Cigna PA form with complete clinical rationale
  • Timeline: Submit 7-10 days before needed
  • Submit via: Cigna provider portal or fax (verify current contact)

4. Follow Up on Decision (Patient/Clinic)

  • Document: PA determination letter
  • Timeline: Standard review within 72 hours for urgent cases
  • Submit via: Check Cigna portal or call member services

5. Appeal if Denied (Patient)

  • Document: Appeal letter with additional evidence
  • Timeline: Within 180 days of denial
  • Submit via: Cigna internal appeal process

6. Request Peer-to-Peer Review (Prescriber)

  • Document: Clinical discussion with Cigna medical director
  • Timeline: Within 5-7 business days of request
  • Submit via: Call Cigna provider services

7. External Review if Needed (Patient)

  • Document: Ohio external review request
  • Timeline: Within 180 days of final internal denial
  • Submit via: Through Cigna to Ohio Department of Insurance

Understanding Cigna's Arikayce Criteria

Cigna's prior authorization requirements for Arikayce are based on the FDA label and clinical evidence. According to Cigna's national PA policy, approval requires:

Core Clinical Criteria:

  • Adult patient (≥18 years) with confirmed MAC lung disease
  • Completion of ≥6 consecutive months of background multidrug regimen
  • Persistent positive MAC cultures despite adequate therapy
  • MAC isolate susceptible to amikacin
  • Concurrent use with background multidrug regimen (not monotherapy)
  • Specialist prescriber or consultation

Background Multidrug Regimen Defined:

  • Macrolide (azithromycin or clarithromycin)
  • Ethambutol
  • Rifamycin (rifampin or rifabutin)
Clinician Corner: Medical Necessity Letter Checklist

Your PA letter should include:Confirmed MAC diagnosis with culture dates and resultsComplete medication history showing ≥6 months of appropriate therapyDocumentation of persistent culture positivityAmikacin susceptibility testing resultsCurrent background regimen that will continue with ArikayceSpecialist involvement in careMonitoring plan for ototoxicity and nephrotoxicity

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Insufficient prior therapy Provide detailed medication history with start/stop dates, doses, and duration ≥6 months
Missing culture documentation Submit recent MAC culture results showing persistent positivity
No amikacin susceptibility Request susceptibility testing from lab; include in resubmission
Lack of specialist involvement Obtain consultation note from pulmonologist or infectious disease specialist
Missing monitoring plan Include baseline audiogram and planned monitoring schedule
Not medically necessary Cite ATS/IDSA guidelines supporting Arikayce for refractory MAC

Appeals Playbook for Ohio Residents

Ohio residents have specific rights when Cigna denies coverage for Arikayce. The appeals process follows both Cigna's internal procedures and Ohio state law.

Internal Appeals with Cigna

Level 1 Internal Appeal:

  • Deadline: 180 days from denial
  • Timeline: Cigna responds within 30 days (expedited: 72 hours)
  • Submit: Written appeal with supporting documentation
  • Contact: Use member services number on insurance card

Level 2 Internal Appeal:

  • Deadline: 60 days from Level 1 denial
  • Timeline: 30 days for decision
  • Requirements: Additional clinical evidence or specialist input

Peer-to-Peer Reviews

Request a peer-to-peer review between your specialist and a Cigna medical director. These clinical discussions have shown to increase approval rates by 15-20% according to industry data. To request:

  1. Call Cigna provider services
  2. Ask for "peer-to-peer review for specialty drug denial"
  3. Provide multiple time windows for the call
  4. Prepare concise case summary and specific approval request

Medical Necessity Documentation

Strong medical necessity documentation is crucial for Arikayce approval. Counterforce Health's platform helps identify the specific denial basis and craft targeted rebuttals, but you can also structure your own appeal using these elements:

Essential Clinical Information:

  • MAC lung disease diagnosis with ICD-10 codes
  • Radiographic evidence (HRCT findings)
  • Microbiologic documentation (culture dates, species, susceptibility)
  • Prior treatment history with specific medications, doses, and durations
  • Clinical response to prior therapy (persistent symptoms, culture status)
  • Rationale for Arikayce as part of combination therapy

Supporting Evidence:

  • ATS/ERS/ESCMID/IDSA guidelines for NTM pulmonary disease
  • FDA label information for Arikayce
  • Peer-reviewed studies on treatment-refractory MAC
  • Specialist consultation notes
From Our Advocates

One common pattern we see is approvals that initially get denied for "insufficient prior therapy" get approved on appeal when the clinical team provides a detailed timeline showing exactly which medications were tried, for how long, and with what results. The key is being specific about dates, doses, and outcomes rather than general statements about "failed multiple therapies."

Ohio External Review Rights

If Cigna's internal appeals are unsuccessful, Ohio residents can request an external review through the Ohio Department of Insurance (ODI). This process is governed by Ohio Revised Code § 3922.05.

Eligibility for External Review:

  • Denial involved medical judgment or medical necessity
  • Internal appeals have been exhausted
  • Request submitted within 180 days of final internal denial

External Review Process:

  1. Request through Cigna (not directly to ODI)
  2. ODI assigns Independent Review Organization (IRO)
  3. Submit additional information within 10 business days
  4. IRO decision within 30 days (72 hours for expedited)
  5. Decision is binding on Cigna if favorable

Ohio Department of Insurance Support:

  • Consumer Hotline: 1-800-686-1526
  • Website: insurance.ohio.gov
  • External Review Forms: Available online with step-by-step instructions

Cost-Saving Options

Even with insurance approval, Arikayce can have significant out-of-pocket costs. Consider these options:

Manufacturer Support:

  • Insmed Patient Access Program
  • Copay assistance for eligible patients
  • Prior authorization support services

Foundation Programs:

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs:

  • Ohio pharmaceutical assistance programs
  • Medicaid coverage for eligible patients

Frequently Asked Questions

How long does Cigna prior authorization take in Ohio? Standard PA decisions are typically made within 72 hours for urgent requests, up to 15 days for non-urgent. Ohio doesn't have specific timelines different from Cigna's national policies.

What if Arikayce is not on Cigna's formulary? You can request a formulary exception by demonstrating medical necessity and providing clinical rationale for why formulary alternatives are inappropriate.

Can I request expedited review for MAC lung disease? Yes, if delay would seriously jeopardize your health. Document the urgent clinical need in your request.

Does step therapy apply to Arikayce? Cigna typically requires documentation of failed standard MAC therapy (macrolide-based regimen) for ≥6 months before approving Arikayce.

What happens if my appeal is denied? You can request external review through the Ohio Department of Insurance, which provides an independent medical review that's binding on Cigna.

How do I prove I've failed standard therapy? Provide medication records showing specific drugs, doses, duration (≥6 months), and culture results demonstrating persistent MAC positivity.

Can my primary care doctor prescribe Arikayce? While possible, Cigna's criteria prefer specialist prescribers (pulmonology or infectious disease) or documented specialist consultation.

What monitoring is required for approval? Baseline audiogram, renal function tests, and planned serial monitoring for ototoxicity and nephrotoxicity are typically required.

When to Contact Ohio Regulators

Contact the Ohio Department of Insurance if:

  • Cigna fails to process your external review request
  • Appeal deadlines are not being honored
  • You need guidance on your appeal rights
  • You suspect improper denial practices

Ohio Department of Insurance:

The ODI can ensure Cigna follows proper procedures and may intervene if your case isn't being handled appropriately.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact official sources for the most current forms and procedures.

Sources & Further Reading:

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