By Counterforce Health Team in Chenodal (chenodiol) —

The Requirements Checklist to Get Chenodal (Chenodiol) Covered by Blue Cross Blue Shield in Virginia

Answer Box: Your Path to Chenodal Coverage

Getting Chenodal (chenodiol) covered by Blue Cross Blue Shield in Virginia requires prior authorization with specific clinical documentation. You'll need proof of radiolucent gallstones, surgical contraindications, and failed ursodiol therapy (unless contraindicated). Submit through your provider using Anthem's PA form with imaging, diagnosis codes, and medical necessity letter. If denied, Virginia's Bureau of Insurance offers external review within 120 days using Form 216-A.

First step today: Contact your prescriber to initiate the prior authorization process through the Anthem provider portal.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. After Submission: What to Expect
  8. Common Denial Reasons & Solutions
  9. Virginia Appeals Process
  10. Printable Checklist

Who Should Use This Checklist

This guide is for Virginia residents with Blue Cross Blue Shield coverage (primarily Anthem Blue Cross Blue Shield) who need Chenodal (chenodiol) for gallstone dissolution. You should use this checklist if:

  • You have radiolucent gallstones confirmed by imaging
  • Surgery is contraindicated due to age or medical conditions
  • Your doctor has recommended Chenodal as an alternative to cholecystectomy
  • You've received a denial and need to understand the appeal process

Expected outcome: With proper documentation meeting all clinical criteria, approval rates improve significantly. Virginia's external review process provides an additional avenue if internal appeals fail.

Member & Plan Basics

Coverage Verification Checklist

Before starting the authorization process, confirm:

  • Active Blue Cross Blue Shield Virginia coverage (check member ID card)
  • Plan type identification (commercial, Medicaid, Medicare - requirements may vary)
  • Deductible status (specialty drugs may require meeting deductible first)
  • Prior authorization requirement confirmed (Chenodal requires PA for most BCBS plans)
Tip: Call the member services number on your ID card to verify your specific plan's specialty drug requirements and preferred pharmacy network.

Clinical Criteria Requirements

FDA-Approved Indications

Chenodal is approved for dissolution of radiolucent cholesterol gallstones in patients who are poor surgical candidates. Your case must meet all of the following criteria:

Patient Eligibility

  • Age 18 or older
  • Radiolucent (non-calcified) gallstones confirmed by imaging
  • Well-opacifying gallbladder on imaging studies
  • Increased surgical risk due to systemic disease or advanced age

Step Therapy Requirements

Most Blue Cross Blue Shield plans require:

  • Ursodiol trial completed (minimum 6 months at 8-10 mg/kg/day)
  • Documentation of ursodiol failure or contraindication
  • Specific reason for discontinuation (lack of response, adverse effects, or medical contraindication)

Contraindication Screening

Patient must NOT have:

  • Preexisting hepatic impairment
  • Bile ductal abnormalities
  • Non-visualizing gallbladder after contrast
  • Pregnancy (absolute contraindication)

Dosing and Duration Limits

  • Maximum dose: 18 mg/kg/day
  • Initial approval: 12 months maximum
  • Total treatment duration: 24 months lifetime maximum
  • Response evaluation: Required at 12-18 months with imaging

Coding & Documentation Requirements

Essential Diagnosis Codes

Condition ICD-10 Code Description
Gallstones without cholecystitis K80.20 Primary billing code
Gallstones with chronic cholecystitis K80.10 If applicable
Surgical contraindication Z53.09 Supporting code for surgical risk

Drug Identification

  • NDC Number: 64193-0900-01 (Chenodal 250mg tablets, 100-count)
  • No HCPCS J-code currently assigned (use NDC for billing)
  • Manufacturer: Travere Therapeutics
Note: Always verify current NDC numbers with your pharmacy, as packaging may change.

Documentation Packet Essentials

Medical Necessity Letter Components

Your prescriber's letter must include:

Clinical Justification

  • Diagnosis statement: Radiolucent gallstones in well-opacifying gallbladder
  • Imaging results summary with dates and findings
  • Surgical risk documentation (specific conditions or age factors)
  • Treatment goals and expected outcomes

Step Therapy Documentation

  • Ursodiol trial details: Start date, duration, dosing
  • Reason for failure: Lack of response, adverse effects, or contraindications
  • Clinical evidence supporting step therapy failure

Treatment Plan

  • Proposed Chenodal dosage (mg/kg/day format)
  • Treatment duration (up to 12 months initial)
  • Monitoring plan for efficacy and safety
  • Response criteria for continuation

Required Attachments

  • Recent imaging studies (ultrasound or CT showing radiolucent stones)
  • Laboratory results (baseline liver function tests)
  • Chart notes documenting surgical contraindications
  • Ursodiol therapy records (if applicable)
  • Any adverse event documentation

Submission Process

Anthem Blue Cross Blue Shield Virginia Submission

  1. Access the provider portal at anthem.com/provider
  2. Download current PA form (forms updated quarterly)
  3. Complete all required fields - incomplete forms cause automatic denials
  4. Submit via portal or fax (verify current fax number on form)
  5. Obtain confirmation number and save for tracking

Timeline Expectations

  • Standard review: 15 business days from complete submission
  • Expedited review: 72 hours (requires urgent medical necessity)
  • Additional information requests: 7-10 days for response
Important: Blue Cross Blue Shield updates coverage criteria quarterly (January, April, July, October). Ensure you're using current forms and criteria.

After Submission: What to Expect

Status Monitoring

  • Record confirmation number from submission
  • Check status weekly through provider portal
  • Document all communications with dates and reference numbers
  • Prepare for peer-to-peer review if requested

Approval Process

If approved:

  • Verify specialty pharmacy network requirements
  • Coordinate prescription transfer if needed
  • Schedule baseline monitoring labs
  • Plan follow-up imaging at 6-12 months

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Step therapy not completed Document ursodiol trial or contraindication Pharmacy records, adverse event notes
Insufficient imaging Submit recent studies showing radiolucent stones Ultrasound or CT reports within 6 months
Missing surgical contraindication Provide detailed risk assessment Specialist consultation, comorbidity documentation
Dosing exceeds limits Adjust to ≤18 mg/kg/day Revised prescription with weight-based calculation
Non-visualizing gallbladder Submit contrast studies showing opacification HIDA scan or oral cholecystogram

Denial Prevention Tips

  1. Use weight-based dosing calculations in all documentation
  2. Include specific imaging dates and findings in letters
  3. Document exact ursodiol trial duration with start/stop dates
  4. Attach all supporting labs and imaging studies
  5. Verify form version is current (check quarterly updates)

Virginia Appeals Process

If your prior authorization is denied, Virginia provides robust appeal rights through the State Corporation Commission Bureau of Insurance.

Internal Appeals Timeline

  • File internal appeal within 180 days of denial
  • Insurer response required within 30-60 days
  • Gather additional documentation during internal review

External Review Process

Virginia's external review is available after completing internal appeals:

Standard External Review

  • File Form 216-A within 120 days of final denial
  • IRO decision timeline: 72 hours for standard exception requests
  • Required documents: Medical records release, insurance card copy, final denial letter

Expedited External Review

  • Complete Form 216-C (physician certification of urgency)
  • IRO decision timeline: 24 hours for urgent requests
  • Criteria: Delay would seriously jeopardize health

Contact Information

Note: Virginia's external review process is binding on insurers and has helped many patients access necessary specialty medications.

Printable Checklist

Pre-Submission Checklist

Patient Eligibility:

  • Age 18+ with radiolucent gallstones
  • Well-opacifying gallbladder on imaging
  • Surgical contraindication documented
  • No hepatic impairment or bile duct abnormalities

Step Therapy:

  • Ursodiol trial completed (6+ months) OR contraindicated
  • Failure/discontinuation reason documented
  • Clinical evidence of inadequate response

Documentation:

  • Medical necessity letter completed
  • Recent imaging studies attached
  • Baseline lab results included
  • Chart notes supporting surgical risk

Submission:

  • Current PA form downloaded
  • All required fields completed
  • Confirmation number obtained
  • Follow-up scheduled

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-backed, targeted rebuttals aligned to each plan's specific requirements. Our platform streamlines the prior authorization process by identifying denial reasons and crafting point-by-point responses with the right clinical evidence and procedural documentation.

For additional support with complex prior authorizations and appeals, visit Counterforce Health to learn how our platform can help strengthen your case with payer-specific workflows and evidence-based appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions are made by your specific plan based on your individual circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage criteria and appeal processes may change; verify current requirements with official sources.

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