How to Get Dojolvi (triheptanoin) Covered by Cigna in Virginia: Complete Appeals Guide
Answer Box: Getting Dojolvi (triheptanoin) Covered by Cigna in Virginia
Cigna requires prior authorization for Dojolvi with molecular confirmation of long-chain fatty acid oxidation disorder (LC-FAOD). Submit through CoverMyMeds or ExpressPAth with genetic test results, diagnosis codes, and clinical rationale. If denied, Virginia law provides step therapy override protections and external review through the State Corporation Commission Bureau of Insurance within 120 days. First step: Have your doctor submit PA with genetic confirmation and previous treatment failures documented.
Table of Contents
- Why Virginia State Rules Matter for Dojolvi Coverage
- Cigna's Prior Authorization Requirements
- Virginia's Step Therapy Override Protections
- Appeals Process: Internal and External Review
- Common Denial Reasons and How to Fix Them
- When and How to File External Review
- Cost Assistance and Patient Support
- Frequently Asked Questions
Why Virginia State Rules Matter for Dojolvi Coverage
Virginia's insurance laws provide specific protections that can help you get Dojolvi (triheptanoin) covered, even when Cigna initially denies your request. These state-level protections work alongside federal requirements and can be particularly powerful for rare disease medications.
Key Virginia Protections:
- Step therapy override requirements that insurers must honor
- External review process through the State Corporation Commission
- Timeline standards for prior authorization decisions
- Consumer assistance through the Bureau of Insurance
Note: These protections apply to fully insured plans. If you have coverage through a self-funded employer plan (ERISA), federal rules apply instead, though many protections are similar.
Plan Type Differences in Virginia
Plan Type | Virginia Law Applies | Appeal Rights | Key Contact |
---|---|---|---|
Individual/Small Group | Yes | Full state protections | SCC Bureau of Insurance |
Large Group (Fully Insured) | Yes | Full state protections | SCC Bureau of Insurance |
Self-Funded ERISA | Limited | Federal ERISA rights | Plan administrator |
Medicare Advantage | No (Federal) | CMS appeal process | Medicare 1-800-MEDICARE |
Cigna's Prior Authorization Requirements
Cigna classifies Dojolvi as a specialty medication requiring prior authorization through their pharmacy benefit manager, typically Express Scripts or Accredo. Here's what you need to know:
Required Documentation
Essential Requirements:
- Molecular/genetic confirmation of LC-FAOD diagnosis
- ICD-10 diagnosis codes (E71.310-E71.318 series)
- Clinical rationale from prescribing physician
- Documentation of medical necessity
- Previous treatment history (if applicable)
Submission Process
Electronic Submission (Fastest):
- CoverMyMeds - Most commonly used portal
- ExpressPAth - Express Scripts' proprietary system
- MyAccredoPatients - For Accredo specialty pharmacy
- Surescripts CompletEPA - EHR integration
Alternative Methods:
- Fax submission when electronic PA unavailable
- Phone requests for urgent cases
- Provider portal through Cigna's website
Tip: Electronic submissions typically process within 72 hours for routine requests, 24 hours for urgent cases.
Timeline Standards
According to Virginia regulations, Cigna must respond to prior authorization requests within:
- 72 hours for standard requests
- 24 hours for urgent/exigent circumstances
- Automatic approval if no response within timeframe
Virginia's Step Therapy Override Protections
Virginia law (§38.2-3407.9:05) requires insurers to grant step therapy exceptions when specific criteria are met. This is particularly relevant for Dojolvi, as some plans may require trying less expensive alternatives first.
Override Criteria
Your doctor can request a step therapy override if:
- The required drug is contraindicated for your condition
- The drug would be ineffective based on your clinical characteristics
- You previously discontinued the required drug due to ineffectiveness or adverse effects
- You're currently stable on Dojolvi under a previous plan
Required Physician Documentation
For LC-FAOD patients, your doctor should document:
- Specific genetic mutation and enzyme deficiency
- Risk of metabolic decompensation with treatment delays
- Previous MCT oil or dietary therapy failures (if applicable)
- Clinical characteristics that make step therapy inappropriate
From our advocates: We've seen successful step therapy overrides when doctors clearly explain that LC-FAOD patients can't safely trial alternative therapies due to the risk of rapid metabolic crisis. The key is emphasizing the time-sensitive nature and genetic confirmation.
Appeals Process: Internal and External Review
If Cigna denies your Dojolvi prior authorization, Virginia provides a structured appeals process with specific timelines and requirements.
Internal Appeals (First Level)
Timeline: Must file within 180 days of denial notice Process:
- Call Cigna member services to initiate appeal
- Submit additional clinical documentation
- Request peer-to-peer review with specialist
- Cigna has 30 days to respond (15 for urgent)
What to Include:
- Copy of denial letter
- Updated clinical notes
- Genetic test results
- Treatment history documentation
- Medical necessity letter from physician
Second-Level Internal Appeal
If first appeal is denied:
- Timeline: 60 days from first denial
- Review: Different medical reviewer
- Response time: 30 days (15 for urgent)
Common Denial Reasons and How to Fix Them
Denial Reason | Solution | Required Documentation |
---|---|---|
"Lack of genetic confirmation" | Submit molecular test results | Genetic testing report with pathogenic variant |
"Concurrent MCT use" | Document discontinuation | Provider note confirming MCT cessation |
"Missing specialist evaluation" | Metabolic specialist consult | Geneticist or metabolic specialist letter |
"Quantity limits exceeded" | Justify dosing based on weight/BSA | Dosing calculation and FDA label reference |
"Not medically necessary" | Comprehensive necessity letter | Clinical guidelines, FDA approval, treatment goals |
Sample Medical Necessity Points
When appealing, ensure your doctor addresses:
- Diagnosis specificity: "Patient has molecularly confirmed VLCAD deficiency"
- Treatment rationale: "Dojolvi provides anaplerotic substrates unavailable through dietary modification"
- Alternative failures: "Previous MCT supplementation resulted in [specific clinical outcomes]"
- Monitoring plan: "Patient will be monitored with [specific labs/assessments]"
External Review Process
If internal appeals fail, Virginia's external review process provides an independent assessment of your case.
Eligibility and Timeline
Who can file: Patients or authorized representatives Deadline: 120 days from final internal denial Cost: Free to consumers Decision timeline: 45 days (72 hours for urgent)
How to File External Review
Required Form: Form 216-A (External Review Request)
Submission Methods:
- Fax: (804) 371-9915
- Email: [email protected]
- Mail: SCC Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
Required Documents:
- Completed Form 216-A
- Copy of denial letters
- Insurance card copy
- Medical records release
- Supporting clinical documentation
Consumer Assistance
Virginia State Corporation Commission Bureau of Insurance
- Phone: (877) 310-6560
- Email: [email protected]
- Website: scc.virginia.gov/boi
Enroll Virginia Navigator Program
- Phone: 1-888-392-5132
- Services: Free help with appeals, forms, and documentation
Cost Assistance Options
Even with insurance coverage, Dojolvi can be expensive. Here are assistance programs:
Manufacturer Support
Ultragenyx RareConnect - Patient assistance program
- Copay assistance for eligible patients
- Free drug program for qualifying uninsured patients
- Prior authorization support services
Foundation Assistance
- National Organization for Rare Disorders (NORD) - Emergency financial assistance
- HealthWell Foundation - Copay assistance for rare diseases
- Patient Access Network (PAN) Foundation - Disease-specific funds
State Programs
Virginia residents may qualify for:
- Virginia Medicaid - Expanded eligibility since 2019
- FAMIS - Children's health insurance program
- Pharmaceutical Assistance Programs - Income-based prescription help
Frequently Asked Questions
How long does Cigna prior authorization take in Virginia? Standard requests: 72 hours. Urgent requests: 24 hours. If Cigna doesn't respond within these timeframes, the request may be considered approved.
What if Dojolvi isn't on Cigna's formulary? You can request a formulary exception with medical justification. Virginia law requires insurers to have an exception process for non-formulary medications.
Can I get expedited review for LC-FAOD? Yes. LC-FAOD can cause rapid metabolic decompensation, qualifying for urgent review timelines. Your doctor must certify that delays could jeopardize your health.
Does step therapy apply if I was stable on Dojolvi with another insurer? No. Virginia law requires step therapy override if you're currently stable on a medication under your current or previous plan.
What happens if external review upholds the denial? The decision is final and binding. However, you may still have legal options or could reapply with additional clinical information.
Are there special protections for children with LC-FAOD? While Virginia doesn't have pediatric-specific override laws, children's cases often qualify for expedited review due to the serious nature of metabolic disorders.
How much does Dojolvi cost without insurance? Cash prices typically range from $5,857-$6,365 per 500-mL bottle, though prices vary by pharmacy and may change.
Can my doctor request a peer-to-peer review? Yes. During the appeals process, your doctor can request to speak directly with Cigna's medical reviewer to discuss your case.
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 the specific denial basis and drafts point-by-point responses aligned with your plan's own rules, pulling the right medical citations and weaving them into appeals that meet procedural requirements.
If you're facing a Dojolvi denial from Cigna in Virginia, don't navigate the appeals process alone. The state provides strong consumer protections, and with the right documentation and persistence, many denials can be successfully overturned. Remember that Virginia's external review process has helped many patients access necessary treatments, and the Bureau of Insurance is there to guide you through the process.
For complex cases involving rare diseases like LC-FAOD, consider working with Counterforce Health or other patient advocacy services that understand the intricacies of specialty drug appeals and can help ensure your case is presented with all necessary clinical evidence and regulatory compliance.
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact the Virginia State Corporation Commission Bureau of Insurance for specific guidance on your insurance situation.
Sources & Further Reading
- Virginia State Corporation Commission Bureau of Insurance - External review process and consumer assistance
- Virginia Code §38.2-3407.9:05 - Step therapy override requirements
- Cigna Prior Authorization Information - Current PA requirements and processes
- Dojolvi FDA Label - Official prescribing information
- Enroll Virginia - Free navigator assistance for insurance appeals
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