By Counterforce Health Team in Thiola / Thiola EC (tiopronin) —

Get Thiola / Thiola EC (Tiopronin) Covered by Aetna CVS Health in New Jersey: Complete PA Guide & Appeals Process

Answer Box: Getting Thiola / Thiola EC Covered by Aetna CVS Health in New Jersey

Thiola and Thiola EC (tiopronin) require prior authorization from Aetna CVS Health for cystinuria treatment. Submit via the Availity provider portal with 24-hour urine cystine levels ≥300 mg/day, genetic testing or stone analysis confirming cystinuria, and documentation of failed conservative therapy. If denied, New Jersey residents can appeal through Aetna's internal process (180 days) then file an external review with Maximus IHCAP within 4 months. Start today: Gather your diagnosis records, urine cystine results, and prior treatment history.

Quick Steps:

  1. Verify PA requirement via Aetna formulary lookup
  2. Submit complete PA packet through Availity portal
  3. If denied, file internal appeal within 180 days
  4. Request external review via New Jersey IHCAP if needed

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Forms and Documentation
  4. Submission Portals and Contact Information
  5. Appeals Process for New Jersey Residents
  6. Common Denial Reasons and Solutions
  7. Cost Savings and Patient Support
  8. When to Escalate to State Regulators
  9. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all non-Medicare Aetna plans Aetna Policy 2991-A SGM P2024b
Formulary Status Specialty tier, CVS Specialty dispensing 2025 Specialty Drug List
Diagnosis Code E72.01 (Cystinuria) with supporting labs ICD-10 requirements
Age Requirement ≥20 kg body weight for pediatric use FDA labeling
Lab Requirements 24-hour urine cystine ≥300 mg/day Aetna clinical criteria
Conservative Therapy Must document failure of hydration, diet, alkalinization Step therapy requirement
Specialist Input Urology/nephrology consultation recommended Clinical best practice

Step-by-Step: Fastest Path to Approval

1. Verify Your Plan Coverage (1-2 days)

Who: Patient or caregiver
Action: Log into your Aetna member portal or call the number on your ID card to confirm Thiola/Thiola EC requires PA
Timeline: Same day
Source: Aetna Member Services

2. Gather Required Documentation (1-2 weeks)

Who: Patient with prescriber's office
Documents needed:

  • 24-hour urine cystine collection results (≥300 mg/day)
  • Genetic testing (SLC3A1/SLC7A9 mutations) or stone analysis (100% cystine)
  • Documentation of failed conservative measures
  • Current lab work (kidney function, urine pH)

3. Complete Prior Authorization Form (2-3 days)

Who: Prescribing physician
Action: Submit via Availity provider portal or fax to CVS Caremark
Required: Medical necessity letter addressing cystinuria diagnosis, failed therapies, and treatment goals
Timeline: 24-48 hours for standard review; 72 hours for expedited

4. Enroll with CVS Specialty Pharmacy (1-2 days post-approval)

Who: Patient
Action: Complete enrollment form, fax to 1-855-297-1270
Timeline: 1-2 business days processing
Note: Required for specialty drug dispensing

Clinician Corner: Medical Necessity Letter Checklist

For Prescribers: Your medical necessity letter should address these key points to meet Aetna's clinical criteria:

✓ Diagnosis Confirmation

  • Document cystinuria via genetic testing (biallelic SLC3A1/SLC7A9 mutations), stone analysis (100% cystine), or hexagonal cystine crystals on urine microscopy
  • Include ICD-10 code E72.01

✓ Laboratory Evidence

  • 24-hour urine cystine ≥300 mg/day (normal <30 mg/day)
  • Include collection methodology and date
  • Current kidney function and urine pH

✓ Failed Conservative Therapy

  • Document trials of high fluid intake (>3L/day)
  • Alkalinization therapy attempts (potassium citrate)
  • Low-methionine diet counseling
  • Reasons for inadequate response or intolerance

✓ Treatment Rationale

  • Cite FDA orphan drug designation for cystinuria
  • Reference urological guidelines supporting thiol-binding therapy
  • Note risk of recurrent stones and kidney damage without treatment

Required Forms and Documentation

Primary PA Form

Aetna Specialty Medication Precertification Request

  • Download PDF
  • Complete all sections including patient demographics, prescription details, and clinical justification
  • Attach supporting documentation (limit 2 pages per attachment)

Alternative Submission Options

  • Electronic PA: CoverMyMeds portal for Aetna Specialty
  • State Uniform Form: Available for New Jersey providers
  • Availity Portal: Integrated PA submission for registered providers

Supporting Documentation Checklist

  • 24-hour urine cystine results
  • Genetic testing or stone analysis report
  • Clinical notes documenting conservative therapy trials
  • Current lab work (kidney function, electrolytes)
  • Imaging studies showing stone burden (if available)
  • Prior authorization denial letters (if resubmitting)

Submission Portals and Contact Information

For Aetna Commercial Plans

CVS Caremark Prior Authorization

  • Fax: 1-877-269-9916 (non-specialty), 1-844-268-7263 (specialty)
  • Phone: 1-855-582-2025 (TTY: 711)
  • Hours: Monday-Friday, 8 AM-6 PM CST
  • Online: Availity portal (provider registration required)

For Aetna Better Health New Jersey (Medicaid)

Member Services: 1-855-232-3596 (TTY: 711), 24/7
Fax: 1-844-679-6853
Address: Aetna Better Health of New Jersey, PO Box 818003, Cleveland, OH 44181-8003

Specialty Pharmacy Enrollment

CVS Specialty Pharmacy
Enrollment Fax: 1-855-297-1270
Phone: 1-800-237-2767
Required: Complete cystinuria enrollment form post-PA approval

Appeals Process for New Jersey Residents

Internal Appeals with Aetna CVS Health

Level 1: Standard Appeal

  • Deadline: 180 days from denial notice
  • Timeline: 30-45 days for decision
  • Submission: Call number on member ID card or submit written appeal
  • Required: Copy of denial letter, additional clinical documentation

Level 2: Expedited Appeal

  • Timeline: 72 hours for urgent cases
  • Criteria: Physician attestation that delay jeopardizes health
  • Same submission methods as standard appeal

New Jersey External Review (IHCAP)

After exhausting Aetna's internal appeals, New Jersey residents can request an independent external review through the state's Independent Health Care Appeals Program (IHCAP), now managed by Maximus Federal Services.

Eligibility Requirements:

  • Completed all internal appeal levels with Aetna
  • Denial based on medical necessity, experimental/investigational status, or similar clinical grounds
  • Filed within 4 months of final internal denial

Submission Process:

  1. Access Forms: Visit njihcap.maximus.com or call for forms
  2. Required Documents:
    • Completed Maximus external appeal form
    • All Aetna denial letters
    • Medical records authorization forms
    • Supporting clinical documentation
  3. Submit Online: Preferred method through IHCAP portal
  4. Alternative Methods: Fax 1-585-425-5296 or mail to address on form

Timeline:

  • Preliminary Review: 5 business days (eligibility determination)
  • Standard Review: Up to 45 calendar days
  • Expedited Review: Up to 48 hours for urgent cases
  • Decision: Binding on Aetna if favorable to patient
From Our Advocates: We've seen several New Jersey patients successfully overturn Aetna denials for cystinuria medications through IHCAP when they provided comprehensive documentation of failed conservative therapy and specialist support. The key was including detailed urine cystine trends showing inadequate response to alkalinization alone. While outcomes vary, thorough preparation significantly improves your chances.

Common Denial Reasons and Solutions

Denial Reason Documentation to Overturn Action Steps
Insufficient diagnosis Genetic testing, stone analysis, or cystine crystals Request urology referral for definitive testing
Conservative therapy not tried Clinical notes showing hydration, diet, alkalinization trials Document 3-6 months of conservative measures with outcomes
Non-formulary status Medical necessity justification, alternatives contraindicated Submit formulary exception request with clinical rationale
Quantity limits exceeded Dosing rationale based on cystine levels, weight, response Include pharmacokinetic justification and monitoring plan
Experimental/investigational FDA approval documentation, clinical guidelines Cite FDA orphan designation and urological society recommendations

Step Therapy Considerations

Aetna may require trial of penicillamine before approving tiopronin. Document any contraindications or previous failures:

  • Penicillamine intolerance: Rash, proteinuria, blood dyscrasias
  • Inadequate response: Persistent high cystine levels or stone formation
  • Patient-specific factors: Pregnancy, autoimmune conditions

Cost Savings and Patient Support

Manufacturer Support Programs

Travere Therapeutics Patient Support

  • Copay assistance for eligible commercially insured patients
  • Free drug programs for qualifying uninsured patients
  • Contact: Check Travere's patient support page for current programs

Foundation Grants

  • National Organization for Rare Disorders (NORD): Medication assistance
  • HealthWell Foundation: Copay support for rare diseases
  • Patient Access Network (PAN): Cystinuria fund (when available)

State Programs

New Jersey residents may qualify for additional assistance through state pharmaceutical programs or Medicaid if income-eligible.

When to Escalate to State Regulators

Contact the New Jersey Department of Banking and Insurance if you experience:

  • Repeated inappropriate denials
  • Failure to follow appeal timelines
  • Lack of response to external review decisions

NJ Department of Banking and Insurance
Consumer Hotline: 1-800-446-7467
IHCAP Specific: 1-888-393-1062
Website: nj.gov/dobi

Frequently Asked Questions

Q: How long does Aetna CVS Health prior authorization take in New Jersey?
A: Standard PA decisions are made within 24-48 hours. Expedited reviews for urgent cases are completed within 72 hours when physician attestation of health risk is provided.

Q: What if Thiola/Thiola EC is not on my Aetna formulary?
A: Submit a formulary exception request along with your PA. Include medical necessity documentation and evidence that formulary alternatives are contraindicated or ineffective.

Q: Can I request an expedited appeal in New Jersey?
A: Yes, both Aetna internal appeals and New Jersey IHCAP external reviews offer expedited processing when delay would jeopardize your health. Physician documentation of urgency is required.

Q: Does step therapy apply if I tried medications outside New Jersey?
A: Yes, Aetna accepts documentation of prior therapy trials from other states. Ensure your prescriber includes detailed records of previous treatments and outcomes.

Q: What happens if CVS Specialty Pharmacy doesn't stock Thiola?
A: CVS Specialty is required to obtain covered medications. If there are delays, contact Aetna member services to request alternative specialty pharmacy dispensing.

Q: How often do I need to renew prior authorization?
A: Initial approvals are typically for 12 months. Renewal requires documentation of continued benefit, such as reduced cystine levels or decreased stone formation.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address specific payer requirements. For complex cases like cystinuria medications, we help identify the exact clinical criteria and documentation needed to meet Aetna's approval standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with your insurance plan and consult with your healthcare provider regarding treatment decisions. For personalized assistance with appeals and prior authorizations, consider consulting with Counterforce Health or other patient advocacy services.

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