By Counterforce Health Team in Kymriah (tisagenlecleucel) —

How to Get Kymriah (tisagenlecleucel) Covered by Aetna (CVS Health) in North Carolina: Complete Guide to Prior Authorization, Appeals, and Coding

Answer Box: Fast Track to Kymriah Coverage

Aetna (CVS Health) requires prior authorization for Kymriah (tisagenlecleucel) in North Carolina. Your fastest path: (1) Confirm CD19-positive pathology and treatment at an Aetna-contracted CAR-T center, (2) Submit PA with complete treatment history via 1-877-212-8811, and (3) Request expedited review (≤72 hours) if your condition is deteriorating. If denied, North Carolina's Smart NC external review program offers binding appeals with particularly fast turnarounds for urgent cases.

Table of Contents

  1. Coverage at a Glance
  2. Medical vs. Pharmacy Benefit Pathways
  3. ICD-10 Coding for Kymriah
  4. HCPCS and Billing Codes
  5. Step-by-Step: Fastest Path to Approval
  6. Common Denial Reasons & Solutions
  7. North Carolina Appeals Process
  8. Verification and Pre-Submission Checklist
  9. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Kymriah patients Aetna PA List
FDA Indication B-cell ALL (≤25 years) or DLBCL (adults, ≥2 lines) FDA Prescribing Information
CD19-Positive Required via pathology report Lab/pathology documentation
Certified Center Aetna-contracted, REMS-enrolled facility Verify with Aetna provider directory
Appeal Deadline 180 days (internal); 120 days (external NC) Smart NC Program

Medical vs. Pharmacy Benefit Pathways

Kymriah follows the medical benefit pathway rather than traditional pharmacy coverage. This cellular therapy requires specialized hospital infrastructure and billing through facility claims.

Medical Benefit (Primary Path):

  • Billed using HCPCS code Q2042 on hospital claims (CMS-1450/UB-04)
  • Revenue codes 0891 or 0636 for outpatient administration
  • Includes T-cell collection, manufacturing, and infusion services
  • Prior authorization through Aetna medical management

Not Pharmacy Benefit:

  • No standard pharmacy dispensing due to specialized CAR-T manufacturing
  • CVS Caremark handles specialty medications, but Kymriah requires hospital-based care
  • Manufacturing is patient-specific and takes 3-4 weeks
Tip: Contact KYMRIAH CARES at 1-844-4KYMRIAH for insurance verification and billing support—they provide free assistance with PA submissions and appeals.

ICD-10 Coding for Kymriah

Accurate diagnosis coding is critical for PA approval. Use these specific ICD-10 codes:

B-cell Acute Lymphoblastic Leukemia:

  • C91.00 - Acute lymphoblastic leukemia, not having achieved remission
  • C91.01 - Acute lymphoblastic leukemia, in remission
  • C91.02 - Acute lymphoblastic leukemia, in relapse

Diffuse Large B-cell Lymphoma:

  • C83.30 - Diffuse large B-cell lymphoma, unspecified site
  • C83.31-C83.39 - Site-specific DLBCL codes (lymph nodes, extranodal)

Documentation Requirements:

  • Pathology report confirming CD19-positive B-cell malignancy
  • Flow cytometry results (CD19+, CD10+, CD20 variable for ALL)
  • Bone marrow biopsy showing >5% blasts (for ALL patients)
  • PET-CT imaging for DLBCL staging and response assessment

The relapse/refractory status in your ICD-10 code (.00, .02) directly supports medical necessity for Kymriah, as FDA approval requires failed prior therapies.

HCPCS and Billing Codes

Primary Code: HCPCS Q2042 covers up to 600 million CAR-positive viable T-cells for all Kymriah indications.

Billing Structure:

  • Use value code 90 for invoice amount on facility claims
  • Include NDC number when required by payer
  • Revenue code 0891 (other therapeutic services) or 0636 (drugs requiring detailed coding)
  • Bill as 1 unit for standard dosing; exceeded doses use fractional units totaling 1.0

Supporting Codes:

  • CPT codes 38225/38226 (replaced 0537T-0539T as of 2025) for CAR-T preparation
  • J3490/J3590/J9999 for exceeded dosing scenarios
  • NCT/Q1 modifier if part of clinical trial
Note: Verify current HCPCS requirements with Aetna during benefits investigation, as coding updates occur annually.

Step-by-Step: Fastest Path to Approval

1. Verify Eligibility and Network Status (Days 1-2)

Who: Patient or clinic staff
Action: Confirm Aetna coverage and locate contracted CAR-T center
Documents: Insurance card, member ID, group number
Timeline: Same day verification via Aetna provider directory

2. Gather Required Documentation (Days 1-3)

Who: Medical team
Action: Compile comprehensive clinical package
Documents Required:

  • CD19-positive pathology report
  • Complete treatment history with dates, doses, outcomes
  • Performance status assessment (Karnofsky ≥50%)
  • Conditioning chemotherapy plan
  • REMS enrollment verification

3. Submit Prior Authorization (Days 3-5)

Who: Oncologist or authorized staff
Action: Call 1-877-212-8811 for PA submission
Process: Obtain reference number, submit supporting documents
Timeline: Standard 30-45 days; expedited ≤72 hours if urgent

4. Request Expedited Review (If Applicable)

Who: Physician
Criteria: Deteriorating condition, poor prognosis, limited bridging options
Action: Document medical urgency in PA request
Timeline: Decision within 72 hours

5. Track Manufacturing Timeline

Who: Patient and clinic
Action: Begin apheresis scheduling while PA pending
Timeline: 3-4 weeks manufacturing post-collection
Resource: KYMRIAH CARES coordinates logistics

Common Denial Reasons & Solutions

Denial Reason Documentation to Submit Appeal Strategy
Not medically necessary Treatment history, NCCN guidelines, FDA label Cite specific prior therapy failures and FDA-approved indications
Missing CD19 positivity Flow cytometry report, pathology results Submit recent immunophenotyping confirming CD19+ status
Non-certified center Network verification, transfer justification Coordinate with Aetna to confirm contracted facilities
Experimental/investigational FDA prescribing information, approval letters Emphasize FDA approval and established safety profile
Inadequate prior therapy Detailed treatment timeline, failure documentation Document ≥2 prior treatment failures per FDA label

Scripts for Common Scenarios:

Patient calling Aetna: "I need to check the status of prior authorization for Kymriah. My member ID is [number] and the reference number is [PA number]. Can you tell me the current status and any additional requirements?"

Clinic requesting peer-to-peer: "I'm requesting a peer-to-peer review for [patient name] regarding Kymriah denial. This is FDA-approved therapy for relapsed/refractory [diagnosis], and the patient meets all medical necessity criteria per your policy."

North Carolina Appeals Process

North Carolina offers robust consumer protections through the Smart NC program, which provides particularly strong support for complex medical appeals like CAR-T therapy denials.

Internal Appeals (First Step)

  • Deadline: 180 days from denial notice
  • Process: Submit written appeal via Aetna member portal or mail
  • Timeline: Decision within 30 days (expedited ≤72 hours)
  • Tip: Request peer-to-peer review with medical director

External Review through Smart NC

North Carolina's external review system offers binding decisions and exceptional support:

Eligibility:

  • State-regulated insurance plan (not self-funded employer plans)
  • Exhausted internal appeals OR qualify for expedited review
  • Denial based on medical necessity or experimental determination

Process:

  1. Submit external review request form
  2. Timeline: 120 days after final internal denial
  3. Decision: Within 45 days (expedited ≤72 hours for urgent cases)
  4. Support: Call Smart NC helpline at 1-855-408-1212 for free guidance

Expedited External Review:

  • Available when delay would seriously jeopardize life or function
  • Decision within 72 hours (often 24-72 hours for urgent drug denials)
  • Smart NC can waive internal appeal requirement for truly urgent cases
From our advocates: "We've seen CAR-T denials successfully overturned in North Carolina when families worked with Smart NC to compile comprehensive medical records and treatment timelines. The key is demonstrating that standard therapies have been tried and failed, with clear documentation of disease progression. Smart NC staff often help families organize complex medical histories into compelling appeals packages."

When to Contact Smart NC

Call 1-855-408-1212 if you need help:

  • Understanding your appeal rights
  • Gathering medical records for external review
  • Filling out external review forms
  • Finding clinical guidelines to support your case

The Smart NC team provides free advocacy and can guide you through the entire appeals process, though they cannot serve as your official representative.

Verification and Pre-Submission Checklist

Before submitting your Kymriah prior authorization, verify these critical elements:

Insurance Verification:

  • Confirm active Aetna coverage and benefits
  • Verify CAR-T center is in Aetna network
  • Check for any quantity limits or site-of-care restrictions
  • Obtain pre-authorization reference number

Clinical Documentation:

  • CD19-positive pathology report (within 6 months)
  • Complete treatment history with specific dates and outcomes
  • Performance status documentation
  • Conditioning chemotherapy plan
  • REMS program enrollment verification

Coding Accuracy:

  • Correct ICD-10 code with remission status (.00, .01, .02)
  • HCPCS Q2042 for billing preparation
  • Revenue codes 0891 or 0636 identified
  • NDC numbers available if required

Appeal Preparation:

  • Copy of insurance denial letter
  • All supporting medical records organized
  • Smart NC contact information saved: 1-855-408-1212
  • External review form downloaded from NC Department of Insurance

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex therapies like Kymriah. Their platform analyzes denial letters, identifies specific policy requirements, and drafts point-by-point rebuttals using the right clinical evidence and regulatory citations—helping patients, clinicians, and specialty pharmacies navigate the challenging prior authorization landscape more effectively.

FAQ

How long does Aetna prior authorization take for Kymriah in North Carolina? Standard PA decisions take 30-45 days, but you can request expedited review (≤72 hours) if your medical condition is deteriorating or you have limited bridging therapy options.

What if Kymriah is not on Aetna's formulary? Kymriah requires prior authorization regardless of formulary status. Submit a formulary exception request with medical necessity documentation if initially denied for non-formulary reasons.

Can I start the appeals process before getting a formal denial? No, you must receive a written denial before filing appeals. However, you can request a peer-to-peer review during the initial PA process to address concerns proactively.

Does step therapy apply to Kymriah? While Aetna doesn't have formal step therapy for Kymriah, you must document prior treatment failures as part of medical necessity criteria. This acts as an informal step therapy requirement.

What happens if my external review is denied in North Carolina? Smart NC's external review decisions are binding on insurers. If approved, Aetna must provide coverage within 3 business days. If denied, you've exhausted administrative remedies, though other legal options may exist.

How much does Kymriah cost without insurance? List prices are approximately $475,000 for ALL and $373,000 for DLBCL, excluding facility and administration costs. Contact KYMRIAH CARES for financial assistance programs if you face coverage challenges.

Can I appeal an Aetna denial if I live in North Carolina but have coverage from another state? If your Aetna plan is regulated by North Carolina (not a self-funded employer plan), you can use Smart NC's external review process regardless of where the plan originated.

Sources & Further Reading

For additional support with complex prior authorizations and appeals, Counterforce Health offers specialized assistance in converting insurance denials into successful approvals through evidence-based appeal strategies.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific coverage decisions. For official North Carolina insurance appeal guidance, contact Smart NC at 1-855-408-1212 or visit the NC Department of Insurance website.

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