By Counterforce Health Team in Chenodal (chenodiol) —

Getting Chenodal (Chenodiol) Approved by Cigna in North Carolina: Complete PA Guide with Appeals Process

Answer Box: Quick Path to Approval

Chenodal (chenodiol) requires prior authorization from Cigna and is covered for radiolucent gallstones when surgery isn't an option. Your fastest path: 1) Have your gastroenterologist document failed ursodiol treatment or contraindication, 2) Submit imaging showing radiolucent stones, 3) Complete Cigna's PA form with medical necessity justification. If denied, North Carolina offers strong external review rights through Smart NC within 120 days. Processing typically takes 2 business days once complete documentation is received.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Step Therapy Requirements
  5. Cost Considerations
  6. Denials and Appeals
  7. Renewals and Monitoring
  8. Specialty Pharmacy Requirements
  9. North Carolina External Review
  10. Common Questions

Coverage Basics

Is Chenodal covered by Cigna? Yes, Chenodal (chenodiol) is included on Cigna's 2024 formularies for commercial and individual plans, but requires prior authorization for all uses.

Which plans cover it? Most Cigna commercial plans, including those managed through Express Scripts pharmacy benefits. Coverage applies to the primary FDA-approved indication: dissolution of radiolucent gallstones in patients who aren't surgical candidates.

Note: Cigna removed coverage for cerebrotendinous xanthomatosis (CTX) effective July 2025, as this indication now applies to a different medication (Ctexli).

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before dispensing Cigna PA forms
Step Therapy Must try ursodiol first Cigna coverage policy
Imaging Required Radiolucent stones confirmed Ultrasound or cholecystogram
Age Restriction 18 years or older FDA labeling requirements
Specialist Involvement Gastroenterologist preferred PA documentation

Prior Authorization Process

Who Submits the PA?

Your prescribing physician (preferably a gastroenterologist) must submit the prior authorization request to Cigna. The process involves completing Cigna's specific PA form with detailed clinical justification.

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documentation (Patient/Clinic)
    • Insurance card and policy details
    • Imaging results showing radiolucent gallstones
    • Documentation of ursodiol trial or contraindication
    • Complete medical history and current symptoms
  2. Complete Clinical Assessment (Prescriber)
    • Confirm diagnosis with appropriate ICD-10 codes
    • Document why surgery isn't appropriate
    • Review contraindications and drug interactions
  3. Submit PA Form (Prescriber)
    • Use Cigna provider portal or fax submission
    • Include all supporting documentation
    • Request expedited review if urgent
  4. Follow Up (Clinic Staff)
    • Track submission status through provider portal
    • Respond promptly to any requests for additional information
  5. Patient Notification (Cigna)
    • Decision communicated within 2 business days
    • Approval includes specific quantity and duration limits

Required Documentation Checklist

  • Completed Cigna PA form
  • Imaging confirming radiolucent gallstones (ultrasound preferred)
  • Documentation of ursodiol trial (minimum 6 months) or contraindication
  • Medical justification for surgical ineligibility
  • Proposed treatment plan and monitoring schedule
  • Current liver function tests (baseline)

Timing and Urgency

Standard Processing: Cigna typically processes PA requests within 2 business days once all required documentation is received.

Expedited Reviews: Available for urgent situations where delay could jeopardize health. Expedited requests are processed within 24-72 hours.

When to Request Expedited Review

  • Severe gallbladder symptoms requiring immediate treatment
  • Patient cannot tolerate current medications
  • Risk of complications from delayed therapy
Tip: Contact Cigna member services at the number on your insurance card to request expedited processing and confirm current timelines.

Step Therapy Requirements

Cigna requires step therapy for Chenodal, meaning patients must first try ursodiol (Actigall) unless medically contraindicated.

Step Therapy Exceptions

You can bypass step therapy if you have:

  • Documented allergy or intolerance to ursodiol
  • Medical contraindications (verify with prescriber)
  • Previous failed treatment with ursodiol (minimum 6 months)
  • Clinical rationale why ursodiol is inappropriate

Documentation for Step Therapy Override

Your prescriber must provide:

  • Specific reason ursodiol cannot be used
  • Duration of previous ursodiol treatment (if applicable)
  • Clinical outcome or adverse effects experienced
  • Medical necessity for Chenodal specifically

Cost Considerations

Insurance Coverage

Chenodal's formulary placement affects your out-of-pocket costs. Most Cigna plans place it on a higher formulary tier, resulting in higher copays or coinsurance.

Financial Assistance Options

Travere Therapeutics CHENODAL Total Care Hub offers:

  • Copay assistance for commercially insured patients
  • Patient assistance program for uninsured/underinsured individuals
  • Contact: 1-888-969-4343
Important: Federal regulations prohibit manufacturer copay assistance for Medicare and Medicaid patients, but patient assistance programs may still apply based on income eligibility.

Typical Cost Ranges

Without insurance or assistance, Chenodal costs vary significantly based on strength and quantity. The manufacturer's Total Care Hub can provide current pricing information and eligibility screening.

Denials and Appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn
No step therapy documentation Submit records showing ursodiol trial or contraindication
Insufficient imaging Provide ultrasound or cholecystogram confirming radiolucent stones
Lack of specialist involvement Have gastroenterologist submit or co-sign request
Missing surgical contraindication Document specific reasons surgery isn't appropriate
Incomplete medical necessity Strengthen clinical justification with guidelines/literature

Internal Appeals Process

Filing Window: Appeals must be submitted within 180 days of the denial notice.

Documentation Required:

  • Original denial letter
  • Completed appeal form
  • Enhanced medical necessity letter
  • Additional supporting evidence (imaging, lab results, specialist notes)

Review Timeline:

  • Standard appeals: 30 days (pre-service) or 60 days (post-service)
  • Expedited appeals: 72 hours for urgent cases

Medical Necessity Letter Checklist

Your prescriber's appeal should include:

  • Specific diagnosis with ICD-10 codes
  • Detailed symptom history and current clinical status
  • Previous treatments tried and outcomes
  • Imaging results and gallstone characteristics
  • Contraindications to surgery
  • Treatment goals and monitoring plan
  • Relevant clinical guidelines or literature support

North Carolina External Review

If Cigna denies your internal appeal, North Carolina residents have strong external review rights through Smart NC.

External Review Process

Eligibility: State-regulated plans (not self-funded employer plans unless they opt in) with denials based on medical necessity or experimental treatment determinations.

Filing Deadline: 120 days after final internal denial

How to Apply:

  1. Contact Smart NC at 1-855-408-1212
  2. Submit external review request form
  3. Provide all relevant medical documentation

Decision Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (24-72 hours for urgent drug denials)

Smart NC Support

Smart NC provides free advocacy and can help you:

  • Complete external review applications
  • Gather supporting medical records
  • Communicate with your insurer
  • Find relevant clinical guidelines
From our advocates: "We've seen several North Carolina patients successfully overturn Chenodal denials through external review when the clinical documentation clearly showed surgical contraindications and failed ursodiol treatment. The key was having comprehensive imaging and detailed specialist notes explaining why medical dissolution was the only viable option."

Renewals and Monitoring

Reauthorization Requirements

Cigna typically requires reauthorization for Chenodal every 6-12 months, depending on your specific plan.

Renewal Documentation:

  • Current liver function tests
  • Treatment response assessment
  • Continued medical necessity
  • Updated imaging if clinically indicated

Monitoring Requirements

Regular monitoring includes:

  • Liver function tests every 3-6 months
  • Symptom assessment and gallstone progression
  • Drug tolerance evaluation

Cigna removed the previous 24-month treatment duration limit, allowing for longer therapy when medically appropriate.

Specialty Pharmacy Requirements

Chenodal may be transferred to a specialty pharmacy (such as Accredo) depending on your Cigna plan's pharmacy benefit design.

Why Specialty Pharmacy?

  • Enhanced clinical monitoring
  • Patient education and support
  • Prior authorization assistance
  • Adherence monitoring programs

Working with Accredo

If your prescription is transferred to Accredo:

  • They'll contact you to coordinate delivery
  • Provide ongoing clinical support
  • Assist with prior authorization renewals
  • Help troubleshoot coverage issues

Contact Accredo at the number provided in your transfer notification for questions about delivery, refills, or coverage.

Common Questions

Q: How long does Cigna PA take in North Carolina? A: Standard processing is 2 business days once complete documentation is received. Expedited reviews are processed within 24-72 hours.

Q: What if Chenodal is non-formulary on my plan? A: You can request a formulary exception with enhanced medical necessity documentation. The process is similar to standard PA but may require additional clinical justification.

Q: Can I request an expedited appeal? A: Yes, if delay could seriously jeopardize your health. Both Cigna internal appeals and North Carolina external reviews offer expedited pathways.

Q: Does step therapy apply if I failed ursodiol in another state? A: Yes, previous ursodiol treatment history from any location counts toward step therapy requirements. Ensure your new prescriber has complete treatment records.

Q: What happens if my appeal is denied? A: You can request external review through Smart NC within 120 days of the final internal denial. This independent review is binding on Cigna.

Q: Are there income limits for manufacturer assistance? A: Yes, Travere's patient assistance program has income eligibility requirements. Contact the CHENODAL Total Care Hub at 1-888-969-4343 for current criteria.

Getting Help with Your Appeal

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform identifies specific denial reasons and drafts point-by-point responses aligned with each payer's own coverage rules, pulling the right clinical evidence and citations to strengthen your case.

For complex denials or if you need additional support navigating Cigna's requirements, Counterforce Health can help patients and clinicians build stronger appeals that address payer-specific workflows and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may vary by plan and can change. Always verify current requirements with your insurance provider and consult with your healthcare provider for medical decisions. For personalized assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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