By Counterforce Health Team in Keytruda (pembrolizumab) —

How to Get Keytruda (Pembrolizumab) Approved by Aetna CVS Health in Virginia: Complete Guide to Prior Authorization, Appeals, and Billing

Answer Box: Getting Keytruda Covered by Aetna CVS Health in Virginia

Prior authorization is required for Keytruda (pembrolizumab) through Aetna CVS Health. Submit your request with complete clinical documentation including PD-L1 test results, pathology reports, and prior therapy records. If denied, Virginia's State Corporation Commission provides external review within 120 days. First step today: Have your doctor call Aetna at (866) 752-7021 to initiate prior authorization and confirm your specific plan requirements.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Aetna plans Call (866) 752-7021 or fax (888) 267-3277 Aetna Precert List
PD-L1 Testing Required for most cancer types Submit test results with PA request Aetna Clinical Policy 0890
Specialty Pharmacy Must use CVS Specialty or network pharmacy Verify with plan CVS Specialty Drug List
HCPCS Code J9271 (1 mg = 1 billing unit) Provider billing Medical billing standards
Appeals Deadline 120 days for Virginia external review Track from denial date Virginia SCC External Review

ICD-10 Coding for Medical Necessity

Accurate diagnosis coding is crucial for Keytruda approval. Your medical team needs to document the specific cancer type and stage using precise ICD-10 codes.

Primary Cancer Diagnosis Codes

Melanoma (C43 series)

  • Use specific anatomical subcodes (C43.0-C43.9)
  • Include laterality when applicable
  • Document metastatic spread with additional codes

Non-Small Cell Lung Cancer

  • Primary: C34.x series for lung location
  • Metastatic: C78.x for secondary respiratory sites
  • Must include PD-L1 testing results

Urothelial Carcinoma

  • C67.x series for bladder location
  • Document prior platinum-based chemotherapy
  • Include staging information

Documentation Requirements

Your oncologist's medical necessity letter should include:

  • Confirmed pathology diagnosis with ICD-10 code
  • Cancer stage and metastatic status
  • PD-L1 expression levels (where required)
  • Prior therapy failures or contraindications
  • Treatment goals and expected duration
Tip: Avoid unspecified codes like C67.9. Aetna's review process favors specific anatomical subcodes that clearly establish the diagnosis.

HCPCS J-Code and Billing Essentials

Keytruda Billing Basics

HCPCS Code: J9271

  • 1 unit = 1 mg of pembrolizumab
  • Standard dose: 200 mg every 3 weeks or 400 mg every 6 weeks
  • Bill exact milligrams administered per infusion

Unit Calculation Examples

  • 200 mg dose = 200 units of J9271
  • 400 mg dose = 400 units of J9271
  • Weight-based dosing: 2 mg/kg × patient weight = total units

Site of Care Requirements

Aetna's Site of Care policy may restrict where Keytruda can be administered. Verify approved settings with your plan:

  • Hospital outpatient departments
  • Physician offices with infusion capabilities
  • Approved infusion centers

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who does it: Medical team Timeline: 1-2 days

  • Complete pathology report with ICD-10 codes
  • PD-L1 test results (if required for your cancer type)
  • Prior therapy records showing failures or intolerances
  • Current staging and imaging results

2. Submit Prior Authorization Request

Who does it: Prescribing physician or staff Timeline: Same day

3. Confirm Specialty Pharmacy Network

Who does it: Patient or clinic Timeline: 1 day

  • Verify CVS Specialty is in-network
  • Arrange delivery logistics
  • Confirm prior authorization transfer

4. Monitor Decision Timeline

Who does it: Patient and clinic Timeline: 30-45 days standard

  • Track submission via Aetna provider portal
  • Request expedited review if medically urgent
  • Prepare appeal documentation if denied

5. Appeal if Necessary

Who does it: Patient with physician support Timeline: Within 180 days of denial

  • Submit additional clinical evidence
  • Request peer-to-peer review
  • Consider Virginia external review process

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing PD-L1 testing Submit test results Lab report with CPS or TPS scores
Wrong line of therapy Document prior failures Treatment records showing progression
Non-formulary status Request formulary exception Clinical rationale for Keytruda over alternatives
Quantity limits exceeded Provide dosing justification Weight-based calculation or protocol citation
Experimental/investigational Cite FDA approval FDA label for specific indication

Virginia External Review Process

If Aetna denies your Keytruda request after internal appeals, Virginia's State Corporation Commission offers independent external review.

Eligibility Requirements

  • Must complete Aetna's internal appeal process first
  • Denial based on medical necessity or experimental treatment determination
  • Request must be filed within 120 days of final denial

Required Forms

Submission Process

Fax: (804) 371-9915
Email: [email protected]
Mail: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218

Timeline

  • Standard review: 45 days maximum
  • Expedited review: 72 hours if delay could jeopardize health
  • Total process: Not to exceed 60 days
Note: Virginia allows expedited external review for cancer treatment denials without exhausting all internal appeals in urgent situations.

Appeals Playbook for Aetna CVS Health

Internal Appeals Process

Level 1: Standard Appeal

  • Deadline: 180 days from denial
  • Timeline: 30-45 days for decision
  • How to file: Written request with additional documentation
  • Required: Copy of denial letter, new clinical evidence

Level 2: Independent Review

  • When: After Level 1 denial
  • Timeline: 30-45 days
  • Process: Independent medical reviewer evaluates case

Expedited Appeals

  • When to use: Urgent medical situations
  • Timeline: 72 hours for decision
  • Required: Physician certification of urgency

Peer-to-Peer Review

Your oncologist can request direct discussion with Aetna's medical director:

  • Schedule through provider services
  • Prepare clinical rationale and guidelines
  • Document conversation outcomes

Costs and Patient Assistance

Keytruda Pricing

  • Approximate cost: $23,591 per 6-week dose
  • Annual treatment cost: $200,000+ depending on regimen
  • Varies by patient weight and dosing schedule

Financial Assistance Options

Merck Patient Assistance Program

  • Income-based eligibility
  • May cover copays or provide free drug
  • Apply through Merck Helps (verify current website)

Foundation Grants

  • Patient Advocate Foundation
  • CancerCare Co-Payment Assistance
  • Leukemia & Lymphoma Society

State Resources Virginia's Medicaid expansion may provide coverage for eligible patients. Contact Virginia Department of Social Services for eligibility screening.

Counterforce Health helps patients navigate the complex prior authorization and appeals process by analyzing denial letters and creating evidence-backed appeals tailored to each payer's specific requirements. Their platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and citations.

Frequently Asked Questions

How long does Aetna prior authorization take for Keytruda in Virginia?

Standard decisions typically take 30-45 days. Expedited reviews for urgent medical situations are decided within 72 hours. Submit complete documentation to avoid delays.

What if Keytruda is not on my Aetna formulary?

Request a formulary exception by having your doctor submit clinical justification explaining why formulary alternatives are not appropriate for your specific cancer type and situation.

Can I request expedited appeal in Virginia?

Yes, if your physician certifies that waiting for standard review could jeopardize your health. Virginia processes expedited external reviews within 72 hours.

Does step therapy apply to Keytruda for cancer treatment?

Step therapy requirements vary by cancer type and line of treatment. Your doctor can request a step therapy override by documenting why first-line treatments failed or are contraindicated.

What happens if Virginia external review upholds the denial?

If the independent review organization upholds Aetna's denial, you may still have options including legal consultation or exploring alternative funding sources through patient assistance programs.

How do I find an in-network specialty pharmacy for Keytruda?

CVS Specialty is typically the preferred network pharmacy for Aetna CVS Health plans. Confirm network status and coordinate delivery with your oncology team.

From our advocates: We've seen many Keytruda denials overturned when patients and their doctors work together to submit comprehensive clinical documentation. The key is often providing complete PD-L1 testing results and detailed records of prior therapy failures. Don't give up after the first denial – Virginia's external review process has helped numerous cancer patients access needed treatments.

When dealing with complex prior authorization requirements, Counterforce Health can help streamline the process by automatically generating targeted appeals that address specific payer criteria and include the right clinical evidence for your situation.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical or legal advice. Always consult with your healthcare providers and insurance plan for specific coverage decisions. For additional help with insurance appeals in Virginia, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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