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

Get Arikayce Covered by Aetna CVS Health in California: Prior Authorization, Appeals, and Coding Guide

Quick Answer: Getting Arikayce Covered by Aetna CVS Health in California

Arikayce (amikacin liposome inhalation) requires prior authorization from Aetna CVS Health for refractory MAC lung disease. Submit your PA request through the Availity provider portal or call 1-866-814-5506. You'll need documentation of 6+ months of failed multidrug therapy, positive MAC cultures, and specialist involvement. If denied, file an internal appeal within 65 days, then escalate to California's DMHC Independent Medical Review (IMR) for a binding external decision. California patients have strong appeal rights with IMR success rates of 45-70% for well-documented specialty drug cases.

First step today: Gather your MAC culture results, prior therapy records, and chest imaging, then have your pulmonologist or infectious disease specialist submit the PA request with complete medical necessity documentation.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Arikayce prescriptions Aetna Precertification List
Formulary Status Specialty tier, non-preferred CVS Caremark formulary
Step Therapy Must fail 6+ months of standard MAC therapy Aetna PA Policy
Specialist Requirement Pulmonologist or infectious disease physician PA policy documentation
Combination Therapy Must be part of multi-drug regimen FDA label requirement
Authorization Period 12 months when approved Standard Aetna policy

Step-by-Step: Fastest Path to Approval

1. Confirm Eligibility (Patient/Clinic)

  • Document: Insurance card, policy details
  • Action: Verify Arikayce is covered under your specific Aetna plan
  • Timeline: Same day
  • Submit via: Member portal or call member services

2. Gather Clinical Documentation (Clinic)

  • Document: MAC culture results, chest CT, treatment history
  • Action: Compile 6+ months of failed therapy records
  • Timeline: 1-2 days
  • Key requirement: Positive cultures despite guideline-based treatment

3. Submit Prior Authorization (Prescriber)

  • Document: PA form with medical necessity letter
  • Action: Submit through Availity portal or fax 1-866-249-6155
  • Timeline: 3-5 business days for decision
  • Contact: Aetna Specialty Precertification 1-866-814-5506

4. Follow Up on Decision (Clinic/Patient)

  • Document: PA approval or denial letter
  • Action: Check status via provider portal
  • Timeline: Standard decisions within 30-45 days
  • Expedited: 72 hours for urgent cases

5. If Denied: File Internal Appeal (Patient/Clinic)

  • Document: Denial letter, additional clinical evidence
  • Action: Submit written appeal within 65 days
  • Timeline: 30 days for standard, 72 hours expedited
  • Submit via: Member portal or mail to address on denial notice

6. If Still Denied: California DMHC IMR (Patient)

  • Document: IMR application, medical records
  • Action: File Independent Medical Review request
  • Timeline: 45 days for decision (72 hours expedited)
  • Contact: DMHC Help Center 888-466-2219

7. Implement Coverage (Pharmacy/Patient)

  • Document: Approval letter, prescription
  • Action: Fill at CVS Specialty or designated pharmacy
  • Timeline: 2-3 days for specialty pharmacy processing
  • Note: May require enrollment in specialty pharmacy program

Prior Authorization Documentation

Clinical Eligibility Criteria

To qualify for Arikayce coverage through Aetna CVS Health, patients must meet specific requirements outlined in Aetna's PA policy:

Disease Status Requirements:

  • Confirmed MAC lung disease with microbiologic and radiographic evidence
  • Refractory disease with limited treatment options
  • No negative sputum cultures after minimum 6 months of multidrug therapy
  • Persistent positive cultures despite prior treatment

Treatment Specifications:

  • Must be used as combination therapy, not monotherapy
  • Isolate must be susceptible to amikacin (MIC ≤64 mcg/mL)
  • No documented amikacin resistance

Required Documentation Checklist

Patient Diagnosis:

  • Complete medical records confirming MAC lung disease diagnosis
  • Recent positive sputum culture reports with species identification
  • Chest imaging (CT scan) consistent with MAC lung disease
  • Clinical symptoms documentation (chronic cough, weight loss, fatigue)

Treatment History:

  • Complete medication list with dates, doses, and duration
  • Documentation of at least 6 consecutive months of guideline-based therapy
  • Pharmacy records showing dispensing history
  • Evidence of treatment adherence and tolerance issues

Medical Necessity Letter:

  • Reference to 2020 ATS/ERS/ESCMID/IDSA guidelines
  • Planned dosing schedule and administration details
  • Monitoring plan for ototoxicity and nephrotoxicity
  • Expected treatment duration and clinical goals
Clinician Corner: Your medical necessity letter should explicitly state that the patient has "refractory MAC lung disease" and reference the specific guideline criteria. Include culture dates, prior antibiotic regimens with start/stop dates, and reasons for discontinuation (failure vs. intolerance). This documentation directly addresses Aetna's coverage criteria and strengthens your case.

Coding That Supports Approval

ICD-10 Diagnosis Coding

The primary diagnosis code for MAC lung disease is A31.0 (Pulmonary mycobacterial infection). This code applies to nontuberculous mycobacteria infections including Mycobacterium avium complex.

Documentation Requirements:

  • Specify "pulmonary MAC disease" in medical records
  • Include radiographic findings and positive cultures
  • Document "refractory" status for treatment justification
  • Exclude tuberculosis (A15-A19) and leprosy (A30)

HCPCS and NDC Coding

For Medical Benefit Claims:

  • HCPCS J-Code: J0690 (Injection, amikacin, 10 mg)
  • Units: 59 units per 590 mg vial
  • NDC: 68232-003-01
  • Alternative: J3490 (unclassified drug) if J0690 not accepted

For Pharmacy Benefit Claims:

  • NDC: 68232-003-01 (590 mg/8.4 mL per vial)
  • No J-code required for pharmacy claims
  • Packaging: 28 vials per carton

Clean Request Anatomy

A properly coded prior authorization should include:

  • Primary diagnosis: A31.0 with supporting documentation
  • Drug information: NDC 68232-003-01, strength, frequency
  • Medical necessity: Failed prior therapies, culture results
  • Prescriber details: Specialist credentials and contact information

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Not meeting 6-month criterion Provide detailed therapy timeline Pharmacy records, prescription history
Off-label use Cite FDA indication and guidelines FDA label, medical literature
Lack of combination regimen Specify concurrent medications Current medication list, treatment plan
Monitoring gaps Submit safety monitoring plan Audiology reports, kidney function tests
Non-formulary status Request formulary exception Medical necessity letter, step therapy documentation
Tip: The most common denial is "insufficient documentation of treatment failure." Counter this by providing a chronological table of all MAC therapies tried, with specific start dates, stop dates, and reasons for discontinuation (lack of efficacy, adverse events, or contraindications).

Appeals Process in California

Internal Appeals with Aetna CVS Health

Timeline: Must file within 65 days of denial notice Process: Submit written appeal through member portal or mail Decision time: 30 days standard, 72 hours expedited Required: Original denial letter, additional clinical evidence

California DMHC Independent Medical Review

California offers robust external appeal rights through the Department of Managed Health Care (DMHC). For specialty drugs like Arikayce, IMR success rates are 45-70% when medical necessity is well-documented.

Eligibility: After internal appeal completion or 30-day waiting period Cost: Free to patients Timeline: 45 days standard, 72 hours expedited Contact: DMHC Help Center 888-466-2219

Required Documents:

  • Completed IMR application
  • Denial letters from health plan
  • Medical records supporting necessity
  • Physician letter explaining clinical rationale
Note: California's IMR decisions are binding on health plans. If the independent medical reviewers determine Arikayce is medically necessary, Aetna must authorize coverage.

When to Escalate

Contact the DMHC Help Center if:

  • Aetna doesn't respond to appeals within required timeframes
  • You need assistance filing an IMR application
  • The health plan isn't following California regulations

Cost Assistance Options

Manufacturer Support:

  • Insmed Patient Assistance Program
  • Copay savings for eligible patients
  • Financial counseling services

Foundation Grants:

  • Patient Access Network Foundation
  • Good Days (formerly CDF)
  • HealthWell Foundation

State Programs:

  • California's AIDS Drug Assistance Program (for qualifying conditions)
  • Medi-Cal coverage for eligible low-income patients

FAQ

How long does Aetna CVS Health prior authorization take in California? Standard PA decisions are made within 30-45 days. Expedited reviews for urgent cases are completed within 72 hours. Submit requests at least two weeks in advance when possible.

What if Arikayce is non-formulary on my plan? You can request a formulary exception with documentation of medical necessity and failed standard therapies. If denied, the California IMR process can override non-formulary restrictions for medically necessary treatments.

Can I request an expedited appeal? Yes, if your condition is urgent or could seriously jeopardize your health. Both Aetna internal appeals and California IMR offer expedited timelines (72 hours) for qualifying situations.

Does step therapy apply if I failed MAC treatment outside California? Yes, treatment failures from any state count toward step therapy requirements. Provide complete medical records and pharmacy dispensing history from all previous locations.

What happens if my appeal is successful? Aetna must authorize coverage retroactively to the original request date. You may be eligible for reimbursement of out-of-pocket costs incurred during the appeal period.

How much does Arikayce cost without insurance? Cash prices typically range from $1,500-$1,600 per vial. A full treatment course requires significant financial resources, making insurance coverage essential for most patients.

Can I use CVS Specialty Pharmacy for Arikayce? Yes, Aetna typically requires specialty drugs like Arikayce to be dispensed through CVS Specialty or other designated specialty pharmacies in their network.

What if I need help with the appeals process? 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 create point-by-point rebuttals that align with each payer's specific requirements, significantly improving approval rates for complex specialty medications like Arikayce.

From Our Advocates: We've seen numerous MAC patients successfully overturn Arikayce denials by focusing on three key elements: comprehensive documentation of failed prior therapies, clear evidence of ongoing positive cultures despite treatment, and strong specialist support letters that reference current guidelines. The combination of thorough preparation and California's patient-friendly IMR process often leads to coverage approval even after initial denials.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual policy terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance.

For additional assistance with California health insurance appeals, contact:

Sources & Further Reading

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