By Counterforce Health Team in Juxtapid (lomitapide) —

The Requirements Checklist to Get Juxtapid (lomitapide) Covered by Blue Cross Blue Shield in North Carolina

Answer Box: Getting Juxtapid Covered in North Carolina

Juxtapid (lomitapide) requires prior authorization from Blue Cross Blue Shield in North Carolina. Success depends on documenting homozygous familial hypercholesterolemia (HoFH) diagnosis, step therapy failures, and liver monitoring plans per FDA REMS requirements. First step: contact your prescriber to initiate prior authorization with comprehensive clinical documentation. If denied, North Carolina's Smart NC external review provides binding appeals within 120 days of final internal denial.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: Next Steps
  9. Common Denial Prevention Tips
  10. Appeals Process in North Carolina
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is for patients with homozygous familial hypercholesterolemia (HoFH) and their healthcare providers seeking Blue Cross Blue Shield coverage for Juxtapid (lomitapide) in North Carolina. You'll need this if:

  • You've been diagnosed with HoFH and need Juxtapid to manage dangerously high cholesterol levels
  • Your doctor has recommended Juxtapid after other treatments haven't achieved target LDL-C reduction
  • You've received a denial and need to understand the appeals process

Expected outcome: Following this checklist increases your chances of approval by ensuring all required documentation is complete and properly formatted for Blue Cross Blue Shield's specific criteria.

Member & Plan Basics

Coverage Verification

Before starting the prior authorization process:

  • Confirm active coverage with Blue Cross Blue Shield of North Carolina
  • Verify your plan type - individual, group, or marketplace plans have different formulary structures
  • Check deductible status - specialty medications like Juxtapid may require meeting your deductible first
  • Review specialty pharmacy requirements - most Blue Cross plans require specialty medications be filled through contracted pharmacies
Tip: Call the member services number on your insurance card to verify Juxtapid's formulary status and tier placement before beginning the authorization process.

Plan-Specific Requirements

Blue Cross Blue Shield plans typically classify Juxtapid as a specialty medication requiring:

  • Prior authorization for all members
  • Specialty pharmacy dispensing
  • Step therapy documentation
  • Ongoing clinical monitoring

Clinical Criteria Requirements

Primary Indication

Juxtapid is FDA-approved exclusively for homozygous familial hypercholesterolemia (HoFH) as an adjunct to low-fat diet and other lipid-lowering treatments. Documentation must clearly establish HoFH diagnosis.

HoFH Diagnosis Documentation

Your medical records must include one of the following:

  1. Genetic testing confirming pathogenic variants in LDLR, APOB, or PCSK9 genes
  2. Untreated LDL cholesterol >500 mg/dL with family history of hypercholesterolemia
  3. LDL cholesterol >300 mg/dL on maximal tolerated lipid-lowering therapy with clinical signs of HoFH

Step Therapy Requirements

Blue Cross Blue Shield typically requires documented failure, contraindication, or intolerance to:

  • Repatha (evolocumab) - PCSK9 inhibitor, usually first-line requirement
  • Evkeeza (evinacumab) - often required before Juxtapid consideration
  • Maximum tolerated statin therapy
  • Ezetimibe when appropriate

Step therapy protocols vary by plan, so verify your specific requirements through Blue Cross Blue Shield's drug search tool.

Laboratory Requirements

Documentation must include:

  • Baseline lipid panel showing LDL-C levels before and during current therapy
  • Liver function tests (ALT, AST, alkaline phosphatase, total bilirubin) within 30 days
  • Pregnancy test for females of reproductive potential (negative result required)

Coding and Documentation

ICD-10 Diagnosis Codes

Primary diagnosis codes for HoFH include:

  • E78.01 - Familial hypercholesterolemia
  • E78.00 - Pure hypercholesterolemia, unspecified (if genetic testing pending)

HCPCS/NDC Information

  • NDC numbers: Multiple strengths available (verify current NDCs with specialty pharmacy)
  • No J-code assigned - Juxtapid is an oral specialty medication
  • Units: Typically dispensed as 28-day supply with specific capsule strengths

Documentation Requirements

Clinical notes must specify:

  • Exact LDL-C levels on current therapy
  • Previous medication trials with specific drugs, doses, duration, and reasons for discontinuation
  • Treatment goals and expected LDL-C reduction targets

Documentation Packet Essentials

Provider Clinical Note Elements

Your prescriber's documentation should include:

  1. HoFH diagnosis confirmation with supporting evidence
  2. Current lipid levels and cardiovascular risk assessment
  3. Prior therapy history with specific failure/intolerance details
  4. Contraindication screening for CYP3A inhibitors
  5. Liver monitoring plan per FDA REMS requirements
  6. Treatment goals and expected clinical outcomes

Letter of Medical Necessity Components

A comprehensive letter should address:

  • Medical problem: HoFH with inadequately controlled LDL-C despite maximal therapy
  • Prior treatments: Specific medications tried, doses, duration, and outcomes
  • Clinical rationale: Why Juxtapid is medically necessary for this patient
  • Monitoring plan: Liver function testing schedule and safety protocols
  • Guideline support: FDA labeling and HoFH management guidelines

Required Attachments

  • Recent lipid panel results
  • Genetic testing report (if available)
  • Previous medication trial documentation
  • Liver function test results
  • REMS program enrollment confirmation
Clinician Corner: The medical necessity letter is often the deciding factor in approval. Focus on documenting the severity of HoFH, the inadequacy of previous treatments, and the specific clinical need for Juxtapid's mechanism of action.

Submission Process

Prior Authorization Forms

Blue Cross Blue Shield requires submission through:

  • Provider portal (preferred method for real-time status updates)
  • Electronic prior authorization through platforms like CoverMyMeds
  • Fax submission to plan-specific prior authorization department
Note: Verify the current submission method with Blue Cross Blue Shield, as processes may vary by plan type and provider network status.

Required Fields and Common Rejections

Ensure all forms include:

  • Complete member information (ID number, group number, date of birth)
  • Prescriber NPI and contact information
  • Specific drug name, strength, and quantity
  • ICD-10 diagnosis codes
  • Clinical justification with supporting documentation

Common rejection reasons:

  • Incomplete member information
  • Missing clinical documentation
  • Incorrect diagnosis codes
  • Failure to address step therapy requirements

Specialty Pharmacy Coordination

REMS Program Requirements

Juxtapid is only available through the FDA REMS program due to hepatotoxicity risks. This requires:

  • Certified prescriber who has completed REMS training
  • Patient enrollment in the REMS program
  • Prescription Authorization Form (PAF) faxed to 1-855-898-2498
  • Liver monitoring plan documentation

Preferred Specialty Pharmacies

Blue Cross Blue Shield typically contracts with specific specialty pharmacies. Common partners include:

  • CVS Specialty
  • Accredo
  • BriovaRx (now part of Walgreens)

Verify your plan's preferred specialty pharmacy network to avoid coverage issues.

Transfer Process

If switching from another pharmacy:

  1. Contact new specialty pharmacy with prescription information
  2. Provide insurance authorization confirmation
  3. Verify REMS program enrollment is current
  4. Confirm shipping address and delivery preferences

After Submission: Next Steps

Tracking Your Request

  • Record confirmation numbers from all submissions
  • Set calendar reminders for follow-up (typically 72 hours for standard review)
  • Document all communications with dates, names, and reference numbers

Status Check Schedule

  • 24-48 hours: Initial acknowledgment of submission
  • 72 hours: Standard prior authorization decision timeframe
  • 7-14 days: Extended review if additional information requested

What to Record

Maintain a file with:

  • Submission confirmation numbers
  • Contact names and phone numbers
  • Decision letters and EOBs
  • Appeal deadlines and requirements

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete HoFH documentation - Ensure genetic testing or clinical criteria are clearly documented
  2. Missing step therapy evidence - Document specific trials of preferred alternatives
  3. Inadequate liver monitoring plan - Include detailed hepatic safety protocols per REMS requirements
  4. Wrong diagnosis codes - Use specific E78.01 for familial hypercholesterolemia
  5. Incomplete REMS enrollment - Verify both prescriber and patient are properly enrolled

Success Strategies

  • Submit comprehensive documentation on first attempt
  • Use plan-specific forms and submission methods
  • Include peer-reviewed evidence supporting Juxtapid use in HoFH
  • Coordinate with specialty pharmacy early in the process
  • Maintain detailed records of all communications

Appeals Process in North Carolina

If your initial prior authorization is denied, North Carolina provides multiple appeal levels:

Internal Appeals

  • Timeline: Submit within 65 days of denial notice
  • Process: Request redetermination with additional clinical evidence
  • Decision timeframe: Approximately 30 days
  • Required: Must exhaust internal appeals before external review

Peer-to-Peer Review

  • When to use: Medical necessity denials
  • Process: Prescriber discusses case directly with plan's medical director
  • Timeline: Usually scheduled within 1-2 business days of request
  • Benefit: Often resolves denials without formal appeal process

Smart NC External Review

North Carolina's external review program provides binding appeals through Smart NC:

  • Eligibility: State-regulated health plans (most individual and small group plans)
  • Timeline: Must request within 120 days of final internal denial
  • Process: Independent Review Organization (IRO) evaluates case
  • Decision timeframe: 45 days standard, 72 hours expedited
  • Cost: Free to consumers
  • Contact: 1-855-408-1212 for assistance
From our advocates: We've seen success with Juxtapid appeals when families work closely with their specialty pharmacy to document the urgency of treatment. One case involved a young adult with HoFH whose LDL-C remained over 400 mg/dL despite maximum therapy - the external review approved coverage within the expedited timeline after comprehensive documentation of cardiovascular risk.

Expedited Appeals

For urgent cases where delays could jeopardize health:

  • Criteria: Dangerously high LDL-C with cardiovascular risk
  • Timeline: 72-hour decision for expedited external review
  • Documentation: Must clearly establish medical urgency
  • Process: Can sometimes waive internal appeal requirements

Quick Reference Checklist

Before You Start

  • Verify active Blue Cross Blue Shield coverage
  • Confirm HoFH diagnosis documentation
  • Complete REMS program enrollment
  • Gather prior therapy documentation
  • Obtain recent liver function tests

Clinical Documentation Required

  • HoFH genetic testing or clinical criteria
  • Current LDL-C levels on maximum therapy
  • Step therapy failures (Repatha, Evkeeza, statins)
  • Liver monitoring plan per REMS requirements
  • Contraindication screening completed
  • Treatment goals specified

Submission Essentials

  • Complete prior authorization form
  • Medical necessity letter
  • Supporting clinical documentation
  • REMS enrollment confirmation
  • Correct diagnosis codes (E78.01)
  • Specialty pharmacy coordination

After Submission

  • Record confirmation numbers
  • Set follow-up reminders
  • Track decision timeline
  • Prepare appeal documentation if needed
  • Maintain communication log

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Juxtapid. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific basis for denial and craft point-by-point rebuttals aligned to each plan's requirements. We help patients, clinicians, and specialty pharmacies navigate the prior authorization process more effectively, reducing back-and-forth and improving approval rates. Learn more about our services.

FAQ

How long does Blue Cross Blue Shield prior authorization take for Juxtapid in North Carolina? Standard prior authorization decisions are typically made within 72 hours of complete submission. Complex cases requiring medical review may take 7-14 days.

What if Juxtapid is not on my Blue Cross Blue Shield formulary? Non-formulary medications can still be covered through formulary exceptions. Submit a prior authorization request with comprehensive medical necessity documentation emphasizing the lack of suitable alternatives.

Can I request an expedited appeal if my LDL-C is dangerously high? Yes, North Carolina allows expedited external review for urgent cases. Document cardiovascular risk and the medical urgency of treatment to qualify for 72-hour decision timelines.

Does step therapy apply if I failed medications in another state? Yes, properly documented treatment failures from other states are generally accepted. Ensure medical records clearly show specific medications tried, doses, duration, and reasons for discontinuation.

What happens if Smart NC external review denies coverage? Smart NC external review decisions are binding on insurers. If approved, your insurer must provide coverage within 3 business days. If denied, you've exhausted administrative appeals but may have other legal rights to pursue.

How much does Juxtapid cost without insurance in North Carolina? Juxtapid typically costs in the mid-five figures per 28-day supply. Contact Chiesi Total Care for patient assistance programs and copay support options.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage determinations. Prior authorization requirements and appeal processes may vary by plan type and individual circumstances. For official guidance on North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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