By Counterforce Health Team in Orkambi (lumacaftor/ivacaftor) —

How to Get Orkambi (lumacaftor/ivacaftor) Covered by Blue Cross Blue Shield in Virginia: PA Forms, Appeal Scripts & State Protections

Answer Box: Getting Orkambi Covered by Blue Cross Blue Shield in Virginia

Blue Cross Blue Shield (Anthem) in Virginia requires prior authorization for Orkambi (lumacaftor/ivacaftor) with genetic testing proving F508del mutations and age ≥2 years. Virginia's step therapy laws protect CF patients with documented contraindications or prior failures. First step: Have your CF specialist submit PA via Anthem's Availity portal with genetic test results, pulmonary function tests, and medical necessity documentation. If denied, Virginia law mandates 72-hour response to step therapy exceptions and provides external review through the State Corporation Commission within 120 days.

Table of Contents

  1. Why Virginia State Rules Matter for Blue Cross Blue Shield Coverage
  2. Blue Cross Blue Shield Prior Authorization Requirements
  3. Virginia Step Therapy Protections for CF Medications
  4. Turnaround Standards and Deadlines
  5. Appeals Playbook: Internal to External Review
  6. Practical Scripts and Documentation
  7. When to Escalate: Virginia State Resources
  8. Cost Assistance and Patient Support
  9. FAQ: Common Questions About Orkambi Coverage

Why Virginia State Rules Matter for Blue Cross Blue Shield Coverage

Virginia's insurance laws provide crucial protections that interact with Blue Cross Blue Shield (Anthem) policies, particularly for specialty medications like Orkambi. Understanding these state-level safeguards can mean the difference between a quick approval and months of appeals.

Key Virginia Protections:

  • Step therapy override rights under Virginia Code §38.2-3407.9:05 for documented contraindications or prior failures
  • 72-hour response requirement for step therapy exception requests (24 hours for urgent cases)
  • External review process through the State Corporation Commission for medical necessity denials
  • Continuity of care requirements during plan transitions
Note: These protections apply to fully-insured commercial Blue Cross Blue Shield plans regulated by Virginia. Self-funded employer plans may have different rules under federal ERISA law.

Blue Cross Blue Shield Prior Authorization Requirements

Anthem Blue Cross Blue Shield in Virginia requires prior authorization for Orkambi as a specialty pharmacy drug effective July 1, 2024.

Coverage Criteria at a Glance

Requirement What It Means Documentation Needed
CF Diagnosis Confirmed cystic fibrosis ICD-10 code, clinic notes
Genetic Testing ≥1 F508del mutation documented CFTR genotype results
Age Requirement ≥2 years per FDA labeling Date of birth verification
Lung Function FEV1 ≥40% predicted (typical) Recent pulmonary function tests
Specialist Care CF center or pulmonologist Provider credentials, clinic notes

Submission Process

For Providers:

  1. Submit via Anthem's Availity portal or call 1-800-552-3387
  2. Include complete genetic testing results showing F508del homozygosity
  3. Attach recent PFTs, clinical notes, and treatment history
  4. Mark as "specialty pharmacy" medication requiring network fill

For Patients:

Tip: Virginia Blue Cross Blue Shield policies vary by employer group. Check your specific benefits booklet for any additional requirements or exclusions.

Virginia Step Therapy Protections for CF Medications

Virginia law provides strong protections for CF patients facing step therapy requirements. Under Virginia Code §38.2-3407.9:05, Blue Cross Blue Shield must grant a step therapy override if any of these criteria are met:

Automatic Override Criteria

  1. Contraindication: The required step drug is contraindicated
    • Known severe hypersensitivity or allergy
    • Genotype mismatch (e.g., wrong CFTR modulator for mutation)
    • Liver disease preventing use of step-required medication
    • Significant drug interactions
  2. Prior Failure/Intolerance: Patient previously tried the step drug
    • Lack of efficacy (documented FEV1 decline, persistent exacerbations)
    • Adverse events (liver toxicity, severe GI effects, mental health impacts)
    • Diminished effect over time despite adherence
    • Note: Drug samples don't count as prior trials
  3. Expected Ineffectiveness: Based on patient characteristics
    • CFTR genotype incompatible with step therapy drug
    • Disease severity requiring more targeted therapy
    • Clinical phenotype suggesting poor response
  4. Stable on Current Therapy: Already achieving positive outcomes
    • Improved or stable lung function on requested drug
    • Reduced exacerbation frequency
    • Better quality of life metrics

Documentation That Works

When requesting a step therapy exception, include specific language:

"This patient meets Virginia step-therapy exception criteria under §38.2-3407.9:05(F) because [specific criterion]. Request immediate coverage of provider-selected prescription drug pursuant to step-therapy exception."

Turnaround Standards and Deadlines

Virginia mandates strict response times for step therapy exceptions and prior authorization requests:

Response Requirements

Request Type Blue Cross Response Time Virginia Law Requirement
Standard Step Therapy Exception 72 hours including weekends Required under §38.2-3407.9:05
Urgent/Exigent Exception 24 hours including weekends For serious jeopardy to health
Standard Prior Authorization 15 business days (typical) Plan-specific timeline
Urgent Prior Authorization 72 hours For immediate medical needs

What Happens If They're Late

If Blue Cross Blue Shield fails to respond within the required timeframes, some guidance indicates the request may be deemed granted for state-regulated plans. Document all submission dates and follow up promptly.

Appeals Playbook: Internal to External Review

Level 1: Internal Appeal

Timeline: File within 180 days of denial notice Process: Submit through Blue Cross member portal or mail written appeal Response time: 30 days for standard, 72 hours for expedited

Required elements:

  • Copy of denial letter
  • Medical records supporting medical necessity
  • Provider letter with clinical rationale
  • Any new evidence (updated PFTs, treatment response data)

Level 2: External Review Through Virginia SCC

If Blue Cross upholds the denial, Virginia provides independent external review through the State Corporation Commission Bureau of Insurance.

Key Details:

  • Timeline: 120 days from final denial to file Form 216-A
  • Cost: Free to consumers
  • Decision time: 45 days standard, 72 hours expedited
  • Binding: Final decision binding on insurer

Contact Information:

  • Virginia Managed Care Ombudsman: 1-877-310-6560
  • SCC Consumer Services: 1-800-552-7945
  • Address: State Corporation Commission, Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218
From our advocates: We've seen CF families succeed in external review by emphasizing the genetic-specific nature of CFTR modulators. One family's external reviewer, a board-certified pulmonologist, overturned a Trikafta denial within 30 days after reviewing genotype data that the original reviewer had overlooked. The key was providing clear documentation that the patient's specific mutations required the requested therapy, not the plan's preferred alternative.

Practical Scripts and Documentation

Patient Phone Script for Blue Cross Blue Shield

"I'm calling about prior authorization for Orkambi for my cystic fibrosis. My doctor submitted the PA [date] but we haven't heard back. Virginia law requires a response within 72 hours for step therapy exceptions. Can you check the status and provide a reference number? If there's a denial, I need the written determination with clinical rationale so we can file an appeal."

Medical Necessity Letter Checklist for Providers

Essential Elements:

  • CF diagnosis with ICD-10 code (E84.-)
  • CFTR genetic testing results (F508del homozygosity documented)
  • Current lung function (FEV1, FVC with percent predicted)
  • Prior CFTR modulator trials and outcomes
  • Contraindications to alternative therapies
  • Treatment goals and expected outcomes
  • Cite FDA labeling and CF Foundation guidelines where applicable

Step Therapy Exception Request Template

"Patient [Name] requires step therapy exception for Orkambi under Virginia Code §38.2-3407.9:05. Criteria met: [Prior failure of Kalydeco with documented FEV1 decline from 65% to 52% over 6 months] OR [Contraindication due to severe hepatotoxicity with alternative agent]. Genetic testing confirms F508del/F508del genotype requiring lumacaftor/ivacaftor combination. Request immediate authorization per state law."

When to Escalate: Virginia State Resources

Virginia State Corporation Commission Support

The Virginia Managed Care Ombudsman provides free assistance with health plan disputes:

Services include:

  • Explaining appeal rights and deadlines
  • Help filing external review requests
  • Coordinating with insurance regulators
  • Informal dispute resolution

When to call:

  • Blue Cross Blue Shield violates response timelines
  • Denial appears to contradict Virginia step therapy law
  • Need help understanding external review process
  • Plan refuses to honor prior authorizations during transitions

Filing a Regulatory Complaint

If Blue Cross Blue Shield violates Virginia insurance laws:

  1. Document the violation (missed deadlines, improper denial rationale)
  2. Contact SCC Consumer Services at 1-800-552-7945
  3. Submit complaint with supporting documentation
  4. Request investigation into plan's compliance with state requirements

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to identify the specific basis for denial—whether PA criteria, step therapy, or "not medically necessary"—and drafts point-by-point rebuttals aligned to the plan's own rules, pulling the right medical evidence and citations for medications like Orkambi.

Cost Assistance and Patient Support

Manufacturer Support Programs

Vertex Pharmaceuticals Patient Services:

  • Copay assistance for eligible commercial insurance
  • Free drug programs for uninsured/underinsured
  • Prior authorization support and appeals assistance
  • Navigate to patient support through official Vertex resources

Virginia-Specific Resources

  • Virginia Medicaid: Covers Orkambi for eligible CF patients
  • ACA Marketplace: Premium tax credits may reduce overall costs
  • CF Foundation Compass: Personalized insurance navigation

Appeal Support Services

Many CF centers offer dedicated insurance coordinators who understand Virginia's appeal process. Counterforce Health provides additional support by automating the appeals process, ensuring submissions meet Virginia's procedural requirements and include the clinical evidence payers expect for buy-and-bill therapies like specialty CF medications.

FAQ: Common Questions About Orkambi Coverage

How long does Blue Cross Blue Shield PA take in Virginia? Standard prior authorization typically takes up to 15 business days, but Virginia law requires 72-hour response for step therapy exceptions and 24 hours for urgent cases.

What if Orkambi is non-formulary on my Blue Cross plan? You can request a formulary exception with medical necessity documentation. Virginia's external review process applies to formulary denials based on medical necessity.

Can I request an expedited appeal in Virginia? Yes, for urgent medical situations where delay could seriously jeopardize health. Expedited external reviews are decided within 72 hours.

Does Virginia step therapy law apply if I failed therapies in another state? Yes, documented prior failures from any location count toward Virginia's step therapy exception criteria, as long as you have medical records proving the trial and outcome.

What happens during Blue Cross Blue Shield plan transitions? Virginia requires continuity of care protections, including honoring existing prior authorizations for at least 30 days during plan changes.

How much does external review cost in Virginia? External review through the State Corporation Commission is completely free for consumers.

Can my CF center help with appeals? Most CF centers have insurance coordinators familiar with Virginia's appeal process and can provide supporting documentation for your case.

What if my employer plan is self-funded? Self-funded ERISA plans may not be subject to Virginia state protections, but you can still request medical exceptions and may have federal external review options through HHS.

Sources & Further Reading

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 decisions. For additional support with insurance appeals and prior authorization processes, contact the Virginia Managed Care Ombudsman at 1-877-310-6560 or visit the State Corporation Commission's Bureau of Insurance website.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.