Author: GDIT, (800) 688-6696
A Clinical Coverage Policy has been developed to add coverage for Chimeric Antigen Receptor (CAR) T-Cell Therapies KYMRIAH and YESCARTA. This policy will become effective Dec. 1, 2019.
The newly covered codes are HCPCS Q2042 (KYMRIAH) and Q2041 (YESCARTA).
HCPCS Q2042
- Generic Name: tisagenlecleucel suspension for intravenous infusion
- Brand Name: KYMRIAH
- For use in inpatient and outpatient hospitals
- KYMRIAH is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of:
- Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or greater relapse;
- Adult patients 18 years of age or older with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
- Limitation of Use: KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma.
- See full prescribing information for further detail.
- Because of the risk of CRS and neurological toxicities, KYMRIAH is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS. Further information is available at http://www.kymriah-rems.com or 1-844-4KYMRIAH. See full prescribing information for complete boxed warning.
HCPCS Q2041
- Generic Name: axicabtagene ciloleucel suspension for intravenous infusion
- Brand Name: YESCARTA
- For use in inpatient and outpatient hospitals
- YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients 18 years of age or older with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
- See full prescribing information for further detail.
- Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA REMS. Further information is available at http://www.YescartaREMS.com or 1-844-454-KITE (5483). See full prescribing information for complete boxed warning.
Prior Approval
NC Medicaid and Health Choice will require Prior Approval (PA) for CAR-T Cell Therapy. PA for CAR-T Cell Therapy must be submitted electronically by the rendering physician through the NCTracks Provider Portal. The following information must be submitted with the request for CAR-T Cell Therapy:
- Letter of medical necessity signed by the attending physician, which documents past chemotherapy regimens and dates, the clinical and social history and indications for treatment with CAR-T cell therapy;
- Copy of contract between administering facility and manufacturer of the requested CAR-T cell therapy;
- Serologies (less than three months old) to include Human Immunodeficiency Virus (HIV) and Hepatitis panel. (Positive serology results may be reported that are greater than three months old.);
- All diagnostic and procedure results, including bone marrow aspiration (not more than six months old);
- Complete psychological and social evaluation to include:
- beneficiary’s medical compliance;
- beneficiary’s support network;
- post-treatment care plan, with identification of primary and secondary care providers; and
- history of mental health issues, substance use, or legal issues.
In addition, the provider must also submit documentation of 30-day patient response to tisagenlecleucel (KYMRIAH) and axicabtagene ciloleucel (YESCARTA) as a follow-up to the prior approval request. This documentation must be attached with claim submission. Medicaid and NC Health Choice will not pay any billed KYMRIAH or YESCARTA charge until after all data regarding the 30-day patient response is received and reviewed.
Quantity limits for KYMRIAH and YESCARTA align with FDA recommended dosing. Prior approval will be authorized for one dose per lifetime. No renewal or exceptions will be allowed.
KYMRIAH and YESCARTA are only available at select Certified Treatment Centers which can be found at https://www.us.kymriah.com/treatment-center-locator/ and https://www.yescarta.com/treatment-centers.
Billing Requirements
Providers will file inpatient claims for CAR-T Cell Therapy with ICD-10 PCS XW033C3 (INTRODUCTION OF ENGINEERED AUTOLOGOUS CHIMERIC ANTIGEN RECEPTOR T-CELL IMMUNOTHERAPY INTO PERIPHERAL VEIN, PERCUTANEOUS APPROACH, NEW TECHNOLOGY GROUP 3) or XW043C3 (INTRODUCTION OF ENGINEERED AUTOLOGOUS CHIMERIC ANTIGEN RECEPTOR T-CELL IMMUNOTHERAPY INTO CENTRAL VEIN, PERCUTANEOUS APPROACH, NEW TECHNOLOGY GROUP 3), include the PA number on the claim and attach documentation regarding 30-day patient response and invoice from manufacturer of CAR-T Cell Therapy.
Providers will file outpatient claims for CAR-T Cell Therapy with Revenue Code 0636 (DRUGS REQUIRING DETAILED CODING) in combination with either Q2042 or Q2041, include the PA number on the claim and attach documentation regarding 30-day patient response and invoice from manufacturer of CAR-T Cell Therapy. Providers billing for 340B drugs will bill the cost that is reflective of the acquisition cost and append the “UD” modifier to the drug detail.
Providers will bill National Drug Codes (NDCs) as follows:
The NDC units must be reported as “UN1.”
Reimbursement
Inpatient Hospital Services: Institutional Claim (UB-04 form/837I transaction)
In accordance with the State Plan, inpatient services for CAR-T Cell Therapy will be reimbursed using the existing DRG payment methodology and will be based on the primary diagnosis code and grouped to the appropriate DRG. Since this will be a covered service, the cost of the CAR-T Cell Therapy will be an allowable cost on the cost report and will be cost settled.
Outpatient Hospital Services: Institutional Claim (UB-04 form/837I transaction)
If the CAR-T Cell Therapy is administered during an outpatient hospital encounter, the infusion is billed on the claim, along with the appropriate HCPCS and NDC codes. If CAR-T Cell Therapy is billed under 340B pricing, the UD modifier must be used. The outpatient hospital claim will be reimbursed according to Medicaid Outpatient Hospital billing guidelines. Similar to inpatient services, the cost is allowable and will be cost settled and considered in the calculation of the MIR/GAP supplemental payments.