By Counterforce Health Team in Darzalex / Darzalex Faspro (daratumumab) —

How to Get Darzalex / Darzalex Faspro (daratumumab) Covered by Aetna (CVS Health) in Virginia: Complete Guide to Prior Authorization, Appeals, and State Protections

Answer Box: Your Fastest Path to Coverage

Getting Darzalex / Darzalex Faspro (daratumumab) covered by Aetna (CVS Health) in Virginia requires prior authorization and often step therapy compliance. Your oncologist must document that bortezomib (the preferred agent) has failed or is contraindicated. Submit Aetna's precertification form via phone (1-866-752-7021) or fax (1-888-267-3277). If denied, Virginia law provides strong appeal protections with 72-hour response times for step therapy exceptions and binding external review through the State Corporation Commission. Start today: Contact your provider to gather prior treatment records and submit the PA request immediately.

Table of Contents

  1. Why Virginia State Rules Matter for Your Coverage
  2. Aetna's Prior Authorization Requirements
  3. Step-by-Step: Fastest Path to Approval
  4. Virginia's Step Therapy Protection Laws
  5. Appeals Process and Timelines
  6. External Review Through Virginia SCC
  7. Common Denial Reasons and How to Fix Them
  8. Practical Scripts and Templates
  9. When to Contact Virginia Regulators
  10. FAQ

Why Virginia State Rules Matter for Your Coverage

Virginia has some of the strongest patient protections in the country for specialty drug access. Unlike many states, Virginia law requires insurers to respond to step therapy exception requests within 72 hours for standard cases and 24 hours for urgent situations. This applies to state-regulated commercial plans (not Medicare or self-funded employer plans).

For patients needing Darzalex / Darzalex Faspro, these protections are crucial because Aetna typically requires you to try bortezomib first. However, Virginia law provides clear pathways to override this requirement when medically appropriate.

Note: These protections apply to Virginia-regulated commercial health plans. Medicare Advantage and most employer self-funded plans follow federal rules, though many still offer similar appeal processes.

Aetna's Prior Authorization Requirements

Aetna (CVS Health) requires prior authorization for both Darzalex and Darzalex Faspro in Virginia. Here's what you need to know:

Coverage Requirements Table

Requirement Details Contact Information
Prior Authorization Required for all indications Phone: 1-866-752-7021
Fax: 1-888-267-3277
Formulary Status Non-preferred (bortezomib preferred) Check current formulary
Step Therapy Must try bortezomib first unless contraindicated Exception process available
Site of Care Approved network infusion centers only Verify with member services
Specialty Pharmacy CVS Specialty Pharmacy required Automatic routing

Required Clinical Documentation

Your oncologist must provide:

  • Diagnosis confirmation with ICD-10 codes (multiple myeloma or AL amyloidosis)
  • Prior therapy history including bortezomib trial results or contraindications
  • Treatment plan including dose, frequency, and duration
  • Premedication protocol (corticosteroids, antihistamines, antipyretics required)
  • Site of care justification if requesting hospital-based infusion

Step-by-Step: Fastest Path to Approval

1. Gather Your Documentation (Patient + Clinic)

  • Insurance card and policy details
  • Complete treatment history with dates and outcomes
  • Current lab results and imaging
  • Previous authorization attempts or denials

2. Complete Aetna's Precertification Form (Clinic)

Download the appropriate form:

3. Submit Request (Clinic)

  • Phone: 1-866-752-7021 (commercial)
  • Fax: 1-888-267-3277
  • Online: Availity portal (preferred method)

4. Track Your Request (Patient + Clinic)

  • Standard response: 15 business days
  • Urgent requests: 72 hours
  • Keep confirmation numbers and reference IDs

5. If Denied: Request Step Therapy Exception (Clinic)

Virginia law requires 72-hour response to exception requests when:

  • Bortezomib is contraindicated
  • Patient failed bortezomib previously
  • Patient would be harmed by delay
  • Patient is stable on current therapy

Virginia's Step Therapy Protection Laws

Virginia Code § 38.2-3407.9:05 provides strong protections for patients facing step therapy requirements. Here's how to use these protections:

Automatic Exception Criteria

Your doctor can request an immediate step therapy override if:

  1. Prior failure: You've tried bortezomib under any plan and it was ineffective or caused adverse effects
  2. Contraindication: Bortezomib would likely cause harm based on your medical history
  3. Ineffectiveness: Clinical characteristics suggest bortezomib won't work for your case
  4. Current stability: You're already stable on Darzalex / Darzalex Faspro with good results

Timeline Requirements

  • Standard exception request: 72 hours for insurer response
  • Urgent/emergency: 24 hours (includes weekends)
  • Appeal window: 180 days if exception is denied
From our advocates: We've seen many Virginia patients successfully override step therapy requirements by having their oncologist document specific adverse reactions to bortezomib from previous treatment attempts. The key is detailed medical records showing why the preferred drug isn't appropriate—Virginia's 72-hour response requirement means you get a quick answer.

Appeals Process and Timelines

If your initial request is denied, Virginia provides a structured appeals process:

Internal Appeals (First Level)

Timeline: 30 days to file from denial notice Response time: 15 business days (72 hours for urgent) How to file:

  • Online through member portal
  • Phone: Number on your member ID card
  • Written appeal to address on denial letter

Required documents:

  • Original denial letter
  • Additional medical records
  • Physician statement of medical necessity
  • Any new clinical evidence

Expedited Appeals

Request expedited review if delay could:

  • Seriously jeopardize your health
  • Impair your ability to regain function
  • Subject you to severe pain

Response time: 72 hours maximum

External Review Through Virginia SCC

If Aetna upholds the denial after internal appeals, Virginia's external review process provides a final, binding decision.

Eligibility Requirements

  • Must complete Aetna's internal appeals process first
  • Denial must be based on medical necessity or experimental treatment determination
  • Must be a Virginia state-regulated plan (not Medicare or most employer plans)

How to File External Review

  1. Download Form 216-A from the Virginia SCC website
  2. Submit within 120 days of final internal denial
  3. Include required documents:
    • Completed Form 216-A
    • Copy of final denial letter
    • Medical records release form
    • Insurance card copy

Contact Information:

External Review Timeline

  • Eligibility determination: 1 business day
  • Independent review: 45 days (72 hours for urgent cases)
  • Insurer compliance: 1-3 days after favorable decision

Common Denial Reasons and How to Fix Them

Denial Reason Solution Required Documentation
Step therapy not met File Virginia step therapy exception Prior bortezomib failure/contraindication records
Not medically necessary Submit peer-reviewed evidence FDA labeling, NCCN guidelines, clinical studies
Non-formulary status Request formulary exception Comparative effectiveness data
Quantity limits exceeded Justify dosing based on weight/BSA Current weight, BSA calculation, dosing rationale
Site of care restriction Document medical necessity for hospital setting Comorbidities, reaction history, monitoring needs

Practical Scripts and Templates

Patient Phone Script for Aetna

"Hi, I'm calling about a prior authorization denial for daratumumab. My member ID is [ID number]. I'd like to understand the specific denial reason and request information about filing an appeal. Can you also tell me about step therapy exception options under Virginia law?"

Clinic Staff Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for [patient name] regarding daratumumab coverage. The patient has documented contraindications to bortezomib including [specific reasons]. Under Virginia Code 38.2-3407.9:05, this qualifies for a step therapy exception. Can we schedule a physician-to-physician review?"

When to Contact Virginia Regulators

Contact the Virginia Office of the Managed Care Ombudsman if:

  • Aetna isn't following required timelines
  • You're having trouble navigating the appeals process
  • You believe your rights under Virginia law are being violated

Contact Information:

  • Phone: 1-877-310-6560 or 1-804-371-9032
  • Services: Free advocacy and guidance for health insurance disputes

For external review assistance:

  • Virginia State Corporation Commission Bureau of Insurance
  • Phone: 1-877-310-6560
  • Website: scc.virginia.gov

Frequently Asked Questions

How long does Aetna prior authorization take in Virginia? Standard requests take up to 15 business days. Urgent requests must be processed within 72 hours under Virginia law.

What if Darzalex / Darzalex Faspro is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Your doctor must provide clinical justification.

Can I request expedited review if I'm currently hospitalized? Yes, Virginia law requires 24-hour response for urgent cases where delay could jeopardize health or cause severe pain.

Does step therapy apply if I failed bortezomib in another state? Yes, Virginia law recognizes prior failures under any health plan. Your doctor should document the previous trial and outcome.

What happens if I miss the 120-day external review deadline? The deadline is strict, but you can contact the Virginia SCC to discuss your situation. In rare cases, extensions may be granted for exceptional circumstances.

How much does external review cost in Virginia? Virginia provides free external review services. There are no fees for patients or providers.

Can I continue my current treatment during appeals? Virginia's continuity of care provisions may allow ongoing treatment during transitions. Check with your plan about continuation policies.

What if my employer plan is self-funded? Self-funded ERISA plans aren't subject to Virginia insurance laws but may voluntarily participate in the state's external review process. Contact the SCC to verify eligibility.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and creates evidence-backed rebuttals tailored to each payer's specific requirements, helping streamline the appeals process for complex medications like Darzalex / Darzalex Faspro.

When dealing with Aetna denials in Virginia, having the right documentation and understanding your state-specific rights can make the difference between coverage and costly out-of-pocket expenses. Virginia's strong patient protection laws, combined with proper preparation and Counterforce Health's systematic approach to appeals, give you multiple pathways to secure coverage for this important therapy.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan details, and medical necessity. Always consult with your healthcare provider and insurance plan directly for coverage determinations. Virginia insurance laws apply to state-regulated plans and may not apply to all coverage types.

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