By Counterforce Health Team in Procysbi (cysteamine bitartrate DR) —

How to Get Procysbi (Cysteamine Bitartrate DR) Covered by Aetna CVS Health in New York: Complete Requirements Checklist

Answer Box: Getting Procysbi Covered by Aetna CVS Health in New York

Procysbi requires prior authorization through CVS Caremark with documented nephropathic cystinosis diagnosis (ICD-10 E72.04), baseline WBC cystine levels, and typically a trial/failure of immediate-release cysteamine. Submit via CVS Specialty Pharmacy enrollment with complete clinical documentation. If denied, file internal appeal within 60 days, then external review with NY DFS within 4 months. First step today: Call the number on your Aetna card to confirm PA requirements and obtain the Procysbi-specific form.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Requirements
  5. Documentation Packet Checklist
  6. Submission Process
  7. CVS Specialty Pharmacy Requirements
  8. After Submission: Tracking & Follow-up
  9. Common Denial Prevention Tips
  10. Appeals Process in New York
  11. Printable Quick Reference

Who Should Use This Checklist

This comprehensive requirements checklist is designed for:

  • Patients with nephropathic cystinosis needing Procysbi coverage through Aetna CVS Health in New York
  • Clinicians and clinic staff submitting prior authorization requests for Procysbi
  • Caregivers and patient advocates navigating the approval process
  • Cases involving step therapy where immediate-release cysteamine has failed or is inappropriate

Expected outcome: With complete documentation following this checklist, most Procysbi prior authorizations are approved within 24-72 hours. Incomplete submissions typically face delays or denials that require appeals.

Member & Plan Basics

Coverage Verification Requirements

Requirement What to Verify How to Check Notes
Active Coverage Member enrolled and premiums current Call member services on Aetna ID card Required before PA submission
Plan Type Commercial, Medicare, Medicaid, Exchange Review insurance card and benefits summary Affects PA forms and timelines
Specialty Drug Coverage Procysbi requires specialty pharmacy Confirm CVS Specialty is preferred/required Most Aetna plans mandate CVS Specialty
Deductible Status Amount applied toward annual deductible Check member portal or call plan May affect out-of-pocket costs
Tip: Aetna's Advanced Control formulary explicitly excludes Procysbi, requiring a formulary exception even with PA approval. Confirm your specific plan's formulary status before starting the PA process.

Clinical Criteria Requirements

Primary Indication Requirements

FDA-Approved Indication: Nephropathic cystinosis in adults and pediatric patients ≥1-2 years (per latest FDA labeling)

Required Clinical Documentation:

  1. Confirmed Diagnosis of Nephropathic Cystinosis
    • ICD-10 code: E72.04 (Cystinosis)
    • Supporting evidence (at least one):
      • Elevated WBC cystine levels (>0.5-1.0 nmol half-cystine/mg protein)
      • Pathogenic CTNS gene mutations
      • Cystine corneal crystals on slit-lamp examination
  2. Baseline Laboratory Values
    • WBC cystine level with date and actual values
    • Target: <1 nmol ½-cystine/mg protein on treatment
    • Normal range: <0.2 nmol/mg protein
  3. Monitoring Plan Documentation
    • WBC cystine levels every 3-6 months
    • CBC monitoring for leukopenia
    • Liver function tests including alkaline phosphatase
    • Renal function monitoring (creatinine, eGFR)

Step Therapy Requirements

Aetna CVS Health typically requires:

  • Trial of immediate-release cysteamine (Cystagon) OR
  • Documented medical contraindication to immediate-release formulation

Acceptable reasons for step therapy override:

  • Severe GI intolerance to immediate-release cysteamine
  • Inability to adhere to 4-times-daily dosing schedule
  • Prior treatment failure with immediate-release formulation
  • Aspiration risk or swallowing difficulties with frequent dosing
  • Documented hospitalizations due to non-adherence

Coding & Documentation Requirements

Essential Medical Codes

Code Type Code Description When Required
ICD-10 E72.04 Cystinosis All PA requests
Additional ICD-10 N16.3 Renal tubulo-interstitial disorders in cystinosis If applicable
Additional ICD-10 N18.5 Chronic kidney disease, stage 5 If ESRD present
NDC Various Procysbi strength-specific codes Pharmacy billing

Dosing Documentation

Required elements:

  • Patient weight and age
  • Prescribed dose and frequency (typically every 12 hours)
  • Dose calculation rationale
  • Target WBC cystine level
  • Duration of therapy (typically long-term/indefinite)

Documentation Packet Checklist

Provider Note Requirements

Your clinical documentation must include:

  • Diagnosis confirmation with supporting test results
  • Complete treatment history including:
    • Prior cysteamine therapy (dates, doses, outcomes)
    • Reason for discontinuation or failure
    • Other nephropathic cystinosis treatments tried
  • Current clinical status and disease progression
  • Baseline and recent lab values (WBC cystine, CBC, LFTs, renal function)
  • Monitoring plan for safety and efficacy

Medical Necessity Letter Components

A strong letter of medical necessity should address:

  1. Patient-specific medical history and disease severity
  2. Clinical rationale for Procysbi vs. immediate-release cysteamine
  3. Treatment goals and expected outcomes
  4. Risk of treatment delay or alternative therapy failure
  5. References to FDA labeling and clinical guidelines where appropriate

Required Attachments

  • Recent clinic notes (within 90 days)
  • Laboratory results (WBC cystine, CBC, comprehensive metabolic panel)
  • Previous treatment records and outcomes
  • Genetic testing results (if available)
  • Ophthalmology reports (if corneal crystals documented)
Note: Incomplete documentation is the #1 cause of Procysbi PA denials. Ensure all elements are included before submission.

Submission Process

Obtaining the Correct PA Form

For Providers:

  1. Access Availity provider portal
  2. Navigate to pharmacy prior authorization section
  3. Search for "Procysbi CVS Health Aetna Prior Authorization Form"
  4. Download current 2024/2025 version

For Patients:

  • Call member services number on Aetna ID card
  • Request "Procysbi prior authorization form and criteria"
  • Ask for form to be sent to prescribing physician

Submission Methods (in order of speed)

  1. Electronic submission via CVS Caremark PA portal (fastest - 24-48 hours)
  2. Fax submission to CVS Caremark specialty PA line
  3. Phone submission for urgent cases
Important: Verify current submission fax numbers and portal links with CVS Caremark, as these change periodically.

CVS Specialty Pharmacy Requirements

Since Aetna typically requires CVS Specialty for Procysbi dispensing:

Enrollment Process

  1. Provider sends prescription directly to CVS Specialty
  2. Complete specialty enrollment form with patient demographics and insurance information
  3. Submit PA documentation concurrently with enrollment
  4. Benefits verification by CVS Specialty team
  5. Patient onboarding call for delivery coordination

Required Information for CVS Specialty

  • Complete prescriber and patient contact information
  • Insurance cards (primary and secondary if applicable)
  • Signed HIPAA authorization and specialty pharmacy consent
  • Clinical documentation supporting medical necessity

Counterforce Health helps patients and clinicians streamline this complex process by automatically generating targeted appeals with the right clinical evidence and procedural requirements for each payer's specific criteria.

After Submission: Tracking & Follow-up

Timeline Expectations

Decision Type Timeline Notes
Standard PA 24-72 hours Most common for complete submissions
Expedited PA 24 hours When medically urgent
Incomplete submission 5-10 business days Additional information requested

Status Tracking Steps

  1. Record confirmation number from submission
  2. Check status within 48 hours via provider portal or phone
  3. Follow up if no decision communicated within expected timeline
  4. Document all communications with dates and reference numbers

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Missing WBC cystine values: Always include actual lab values with dates and normal ranges
  2. Inadequate step therapy documentation: Provide specific dates, doses, and outcomes of immediate-release cysteamine trial
  3. Incomplete diagnosis documentation: Include genetic testing or corneal crystal findings when available
  4. Wrong PA form: Ensure you're using the current Procysbi-specific form for your plan type
  5. Missing monitoring plan: Detail ongoing lab monitoring schedule and safety assessments

Success Factors

  • Submit complete documentation package on first attempt
  • Use CVS Specialty enrollment to coordinate PA and dispensing
  • Maintain detailed records of all prior treatments
  • Include objective measures of disease control and treatment response

Appeals Process in New York

Internal Appeal with Aetna

Timeline: File within 60 days of denial Decision: Within 30 days (standard) or 72 hours (expedited)

Required elements:

  • Written appeal letter addressing specific denial reasons
  • Updated medical necessity documentation
  • Additional clinical evidence supporting coverage

New York State External Review

After completing Aetna's internal appeal process:

Timeline: File with NY DFS within 4 months of final internal denial Decision: 30 days (standard) or 72 hours (expedited) Cost: Up to $25 (waived for financial hardship, refunded if successful)

Key advantages in New York:

  • Independent medical expert review
  • Binding decision on insurer
  • Strong track record for specialty medication appeals
  • Expedited process for urgent medical needs

For external appeals, contact New York State Department of Financial Services or call Community Health Advocates at 888-614-5400 for free assistance.

Printable Quick Reference

Pre-Submission Checklist

Patient Information:

  • Active Aetna CVS Health coverage verified
  • Member ID and policy information confirmed
  • CVS Specialty Pharmacy requirement confirmed

Clinical Documentation:

  • ICD-10 E72.04 nephropathic cystinosis diagnosis
  • WBC cystine levels (baseline and recent)
  • Complete treatment history with immediate-release cysteamine
  • Medical necessity letter addressing step therapy
  • Monitoring plan for ongoing therapy

Submission Requirements:

  • Current Procysbi PA form completed
  • All required attachments included
  • Submission method confirmed (portal vs. fax)
  • CVS Specialty enrollment initiated if required

Post-Submission:

  • Confirmation number recorded
  • Follow-up schedule established
  • Appeal timeline noted if needed

This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual medical circumstances and specific insurance plan terms. For personalized assistance with your coverage situation, consult with your healthcare provider and insurance representative.

Need help with a complex denial or appeal? Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed arguments tailored to each payer's specific requirements and decision-making criteria.

Sources & Further Reading

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