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

How to Get Arikayce Covered by Blue Cross Blue Shield in New York: Prior Authorization Forms, Appeal Scripts, and External Review

Quick Answer: Getting Arikayce Covered by Blue Cross Blue Shield in New York

Blue Cross Blue Shield of New York requires prior authorization for Arikayce (amikacin liposome inhalation) for refractory MAC lung disease. Submit PA via Availity Essentials with proof of 6+ months failed combination therapy and positive sputum cultures. If denied, file internal appeal within 60 days, then external review through NY Department of Financial Services within 4 months. First step today: Call member services (number on your card) to request PA forms and confirm specific criteria for your plan.

Table of Contents

  1. Policy Overview: How BCBS New York Covers Arikayce
  2. Indication Requirements: What Qualifies as Medical Necessity
  3. Step Therapy & Exceptions: Required Trials and Workarounds
  4. Quantity Limits and Renewal Thresholds
  5. Required Diagnostics and Documentation
  6. Site of Care and Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Sample "Meets Criteria" Documentation
  9. Appeals Playbook for BCBS New York
  10. Common Denial Reasons & How to Fix Them
  11. Cost and Patient Support Options

Policy Overview: How BCBS New York Covers Arikayce

Blue Cross Blue Shield of New York (Anthem BCBS NY) treats Arikayce as a specialty drug requiring prior authorization across individual, commercial, and Medicare Advantage plans. The drug falls under medical benefit coverage rather than pharmacy benefit due to its specialized administration requirements.

Plan Types and Coverage:

  • Commercial/Individual plans: Full PA required via Availity portal
  • Medicare Advantage: May have additional CMS requirements
  • Medicaid managed care: Coordinated through NY Medicaid formulary

All BCBS New York plans must follow the same basic utilization management principles, but specific criteria may vary slightly between product lines. Check your specific plan's formulary for tier placement and any additional restrictions.

Indication Requirements: What Qualifies as Medical Necessity

FDA-Approved Indication: Arikayce is approved for adults with Mycobacterium avium complex (MAC) lung disease who remain culture-positive after at least 6 consecutive months of multidrug background therapy, used as part of a combination antibacterial regimen.

BCBS New York's Medical Necessity Criteria

Based on BCBS utilization management guidelines, documentation must include:

Required Elements:

  • Confirmed MAC lung disease diagnosis with ICD-10 codes
  • Minimum 2 positive sputum cultures for MAC
  • Evidence of refractory disease (persistent positive cultures after 6+ months combination therapy)
  • Amikacin susceptibility testing (MIC ≤64 mcg/mL)
  • Patient age ≥18 years
  • Planned use as part of combination regimen

Off-Label Use: BCBS typically denies off-label requests for Arikayce unless supported by major clinical guidelines and documented failure of all standard therapies.

Step Therapy & Exceptions: Required Trials and Workarounds

Standard MAC Treatment Progression

BCBS New York generally requires documentation of failure with standard MAC regimens before approving Arikayce:

  1. First-line combination: Azithromycin/clarithromycin + ethambutol + rifamycin
  2. Duration requirement: Minimum 6 consecutive months
  3. Failure definition: Persistent positive sputum cultures despite adequate therapy

Medical Exception Pathways

Contraindications to standard therapy:

  • Document specific drug allergies or intolerances
  • Include rechallenge attempts if clinically appropriate
  • Provide alternative medication trials and outcomes

Accelerated approval scenarios:

  • Severe disease progression
  • Limited treatment options due to resistance patterns
  • Prior serious adverse events with standard regimens
Tip: Include pharmacist consultation notes documenting drug interactions or contraindications to strengthen exception requests.

Quantity Limits and Renewal Thresholds

Initial Authorization Period: 6 months (aligned with CONVERT trial endpoint)

Renewal Requirements:

  • Clinical response documentation
  • Updated sputum culture results
  • Tolerability assessment
  • Ongoing combination therapy confirmation

Quantity per Fill:

  • Standard: 30-day supply (30 vials of 590 mg)
  • No early refill allowances without clinical justification

Long-term Coverage: ATS/ERS guidelines recommend total MAC treatment duration of 12+ months after culture conversion, requiring ongoing reauthorizations.

Required Diagnostics and Documentation

Essential Lab Work and Imaging

Pre-treatment Requirements:

  • Baseline audiometry (ototoxicity monitoring)
  • Serum creatinine and BUN (nephrotoxicity screening)
  • Chest CT or high-resolution CT showing MAC disease
  • Sputum culture and sensitivity (including amikacin MIC)

Ongoing Monitoring:

  • Monthly sputum cultures during treatment
  • Audiometry every 3 months or if symptoms develop
  • Renal function monitoring per clinical judgment

Documentation Best Practices

Medical Records Must Include:

  • Detailed treatment history with dates, dosages, and durations
  • Specific reasons for treatment failures (lack of efficacy vs. intolerance)
  • Objective measures of disease severity (imaging, culture load)
  • Patient's functional status and quality of life impact
Note: BCBS reviewers pay close attention to the 6-month requirement. Ensure documentation clearly shows consecutive months of appropriate combination therapy before Arikayce consideration.

Site of Care and Specialty Pharmacy Requirements

Mandatory Specialty Pharmacy Distribution:

Arikayce is available only through three manufacturer-designated pharmacies, regardless of your BCBS plan:

  • Amber Specialty Pharmacy: 1-888-370-1724
  • Maxor Specialty Pharmacy: 1-866-629-6779
  • PANTHERx Rare Pharmacy: 1-855-726-8479

Home Administration Model:

  • Self-administration via Lamira Nebulizer System
  • No hospital or infusion center requirement
  • Patient training provided through inLighten support program

340B Program Access: For eligible healthcare facilities, orders can be placed through ASD Healthcare (1-800-746-6273) with appropriate documentation.

Evidence to Support Medical Necessity

Key Clinical Evidence to Cite

Primary Trial Data:

  • CONVERT Phase 3 trial: 29% culture conversion with Arikayce + background vs. 9% background alone
  • Time to culture conversion: median 5.9 months with Arikayce

Guideline Support:

Resistance and Susceptibility:

  • Include amikacin MIC testing results
  • Document resistance patterns to other agents if available
  • Reference local epidemiology data when relevant

When navigating complex insurance approvals for specialty medications like Arikayce, Counterforce Health helps patients and clinicians turn denials into successful appeals by analyzing payer policies and crafting evidence-based rebuttals tailored to specific plan requirements.

Sample "Meets Criteria" Documentation

Template Medical Necessity Letter

"This 45-year-old patient has culture-confirmed MAC lung disease (ICD-10: A31.0) with persistent positive sputum cultures despite 8 months of guideline-directed combination therapy including clarithromycin 500mg BID, ethambutol 800mg daily, and rifampin 600mg daily. Serial sputum cultures from [dates] demonstrate ongoing MAC growth with amikacin susceptibility (MIC 32 mcg/mL).

Current symptoms include productive cough, dyspnea on exertion, and 15-pound weight loss. High-resolution chest CT shows progressive cavitary disease in the right upper lobe. Standard therapy has been optimized with confirmed adherence and appropriate drug levels.

Per 2020 ATS/ERS/ESCMID/IDSA guidelines, Arikayce is recommended for this clinical scenario of refractory MAC disease. The patient meets all FDA labeling criteria and will continue background therapy with close monitoring including monthly cultures and quarterly audiometry."

Appeals Playbook for BCBS New York

Internal Appeal Process

Timeline: 60 days from denial notice Submission: Anthem BCBS NY provider portal or member services fax

Required Documents:

  • Original denial letter
  • Updated medical records
  • Physician attestation letter
  • Supporting literature/guidelines

External Review Through NY Department of Financial Services

Eligibility: After internal appeal denial for medical necessity determinations Timeline: 4 months from final adverse determination Cost: $25 (waived for Medicaid/financial hardship)

Submission Options:

  • Online: DFS Portal (preferred)
  • Email: [email protected]
  • Fax: 800-332-2729
  • Mail: DFS, 99 Washington Ave, Box 177, Albany, NY 12210

Expedited Review: 72 hours for urgent cases (24 hours for formulary exceptions)

Important: New York's external appeal system has binding decisions on insurers. The state maintains a searchable database of past decisions to help strengthen your case.

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
Insufficient treatment duration Document exact dates and durations of prior therapy Pharmacy records, prescription history
Missing culture data Submit all sputum culture results Lab reports with dates and sensitivity
Off-label use request Provide guideline support and contraindication documentation ATS/ERS guidelines, allergy records
Lack of specialist involvement Include pulmonologist or ID specialist attestation Specialist consultation notes
Missing monitoring plan Detail audiometry and renal function monitoring schedule Baseline test results, monitoring protocol

Free Help Available

Community Health Advocates: Call 888-614-5400 (Mon-Fri, 9am-4pm) for free assistance with BCBS denials and appeals in New York. They provide template letters, track deadlines, and help with external review submissions.

Cost and Patient Support Options

Manufacturer Support Programs

inLighten Patient Support:

Financial Assistance:

  • Copay cards for commercially insured patients
  • Patient assistance program for uninsured/underinsured
  • 340B pricing for eligible facilities

State and Foundation Resources

New York State Programs:

  • Medicaid coverage for eligible patients
  • Essential Plan for low-income individuals
  • EPIC prescription assistance for seniors

For complex prior authorization challenges, Counterforce Health's platform analyzes BCBS policies and generates targeted appeals that address specific denial reasons with evidence-backed rebuttals.

From Our Advocates: "We've seen Arikayce denials overturned when families provided complete documentation of the 6-month treatment failure period. The key is organizing pharmacy records to show exact dates and durations—BCBS reviewers count every day. One patient's appeal succeeded after we helped document treatment adherence through pill counts and blood levels, proving the regimen truly failed rather than wasn't properly tried."

FAQ: Arikayce Coverage by BCBS New York

Q: How long does BCBS prior authorization take for Arikayce? A: Standard review is 3-5 business days. Expedited review (with clinical urgency documentation) can be completed within 24-72 hours.

Q: What if Arikayce isn't on my BCBS formulary? A: Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives have failed or are contraindicated.

Q: Can I appeal if I haven't tried all standard MAC therapies? A: Yes, if you can document medical contraindications or serious adverse events with standard agents. Include allergy testing and rechallenge attempts when appropriate.

Q: Does step therapy apply if I failed treatments outside New York? A: BCBS should accept properly documented treatment failures from other states. Ensure records include specific drugs, dosages, durations, and failure reasons.

Q: What happens if my external appeal is approved? A: BCBS must cover the treatment and refund your $25 appeal fee. The decision is binding and applies to future similar requests.

Q: Can my doctor request a peer-to-peer review? A: Yes. Contact BCBS medical director through the number on your denial letter. Have complete medical records and supporting literature ready.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For official appeals assistance in New York, contact Community Health Advocates at 888-614-5400 or the NY Department of Financial Services.

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