(Medicare Claims Processing Manual)

Scenario 3: CAR T -cell Dosing and Preparation Services in HOPD Setting, but Viable T -cells Administered in the Hospital Inpatient Setting:  When CAR T -cell preparation services are initiated and furnished in the HOPD setting, but the CAR T -cells are administered in the inpatient setting, the hospital shall not report the CAR T -cell product HCPCS code (which only applies when viable T -cells are administered in the outpatient setting). Report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891  Special Processed Drugs  FDA (U.S. Food and Drug Administration) Approved Cell Therapy  Charges  for Modified cell therapy.  Note:  When the cells are collected in the HOPD setting and the CAR T -cell product is administered in the hospital inpatient setting, inpatient providers shall report the date that the CAR T -cell administration took place and not the date the cells were collected.  Physician Office or Non -Hospital Clinic   The A/B MAC billing requirements will pay for CAR T -cell therapy products when the services are submitted in places of service 11 or 49. Proper adjudication of payment is based on fractionated units.  The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the Form CMS -1500 or electronic 837P.   Scenario 1: CAR T -cell Dosing and Preparation Services and Viable T -cells Administered in Physician Office or Non-Hospital Clinic:   In instances when a physician or non-physician provider  administers the CAR T-cells product in the physician office setting or other non- hospital clinic setting that is enrolled in the REMS program as a REMS participating site, report CPT code 0540T for the administration and CAR T-cell product HCPCS code Q2041, Q2042, Q2053 (effective April 1, 2021), Q2054 (effective October 1, 2021), Q2055 (effective January 1, 2022), Q2056 (effective October 1, 2022), or, if a more specific code is unavailable, the most appropriate unclassified drug code (e.g., J3590 for unclassified biologics). For specific instructions on billing unclassified drug codes, refer to Chapter 26, Section 10.4 of the Medicare Claims Processing Manual on the CMS website at: Regulations- and-Guidance.Ch26.   The procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the various steps required to collect and prepare the genetically modified T- cells, and these steps are not paid separately under the MPFS. However, you may report them separately, and Medicare will deny them on the professional claim as Medicare does not pay separately for this service.   Note:  Practitioners shall code the CAR T -cell product service on the date that the CAR T -cells administration took place and not on the date when the cells were collected.    Scenario 2: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Not Administered:   In instances when the CAR T -cell product is not ultimately administered to the beneficiary, but the CAR T- cells preparation services are initiated or performed in the physician office or other non- hospital clinic facility, the practitioner shall not report the CAR T -cell product HCPCS code (which only applies when viable T- cells are administered). The practitioner may report CPT codes 0537T, 0538T, and 0539T (as appropriate) on the professional claim. Medicare will deny these codes as Medicare does not pay separately for this service.   Scenario 3: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Administered in the Hospital Inpatient Setting:   When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T- cells are administered in the hospital inpatient setting, the practitioner shall not report the CAR T-cells product HCPCS code (which only applies when viable T- cells are administered in the outpatient setting). The hospital that administers the T -cells will report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue codes 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891  Special Process ed Drugs  FDA (U.S. Food and Drug Administration) Approved Cell Therapy  Charges for Modified cell therapy.   Note:  When the cells are collected in the physician office setting and the CAR T -cell product is administered in the hospital inpatient setting, inpatient providers shall report the date that the CAR T -cell administration took place and not the date the cells w ere collected.   Scenario 4: CAR T -cells Dosing and Preparation Services in Physician Office or Non -Hospital Clinic, but Viable T-cells Administered in the HOPD Setting:   When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T -cells are administered in the HOPD setting, the practitioner shall not report the CAR T -cell product HCPCS code (which only applies when the viable T -cells are administered). The HOPD that administers the T -cells may report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the HOPD claim. Medicare will reject these codes.   Note:  When the cells are collected in the physician office setting and the CAR T -cell product is administered in the HOPD setting, HOPD providers shall report the date that the CAR T -cell administration took place and not the date the cells were collected.   39T (as appropriate) on the professional claim. Medicare will reject these codes.  Scenario 3: CAR -T Dosing and Preparation Services Administered in Physician Office or Non -Hospital Clinic, but Viable T -cells Administered in the Hospital Inpatient Setting:  When CAR T -cell preparation services are initiated and furnished in the physician office or other non- hospital clinic setting, but the CAR T -cells are administered in the inpatient setting, the practitioner may not report the drug HCPCS code (which only applies when the T -cells are administered in the setting). The hospital that administers the T -cells will report the charge associated with the various steps to collect and prepare the CAR T -cells on the inpatient claim (TOB 11x) separately using revenue cod es 0871, 0872, or 0873. Alternatively, the hospital may include the charges for these various steps in the charge reported for the biological using revenue code 0891  Special Processed Drugs  FDA (U.S. Food and Drug Administration) Approved Cell Therapy  Charges for Modified cell therapy.  Note : When the cells are collected in the physician office setting and the CAR -T is administered in the hospital inpatient setting, inpatient providers should report the date that the CAR -T administration took place and not the date the cells were collected.   400.4 - Claim Adjustment Reason Codes (CARCs), Remittance Advice Remark Codes (RARCs), Group Codes, and Medicare Summary Notice (MSN) Messages (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  Contractors shall continue to use the appropriate existing messages that they have in place when denying claims submitted that do not meet the Medicare coverage criteria for CAR T -cell therapy.   --Contractors shall deny claims for CAR T -cell therapy when the service is not administered through healthcare facilities that are enrolled in the FDA REMS requirements using the following messages:   CARC 58 Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service.  Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.   RARC N386  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   Group Code CO (Contractual Obligations).  MSN 16.2  This service cannot be paid when provided in this location/facility.   Spanish Version  Este servicio no se puede pagar cuando es suministrado en esta sitio/facilidad.   In addition to the codes listed above, contractors shall afford appeal rights to all denied parties.   --When denying claims for covered CAR T -cell therapy procedures because the appropriate ICD -10 coding was not used, use the following messages:   CARC 50 -  These are non -covered services  because this is not deemed a "medical necessity" by the payer. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.   RARC N386 -  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   Group Code CO or PR dependent upon liability.  MSN 15.20 -  The following polices were used when we made this decision: NCD 110.24.  Spanish Version  Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24.   --When denying claims for covered CAR T -cell therapy procedures because they are not performed in POS 11 or 49, use the following messages:   CARC 58 Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.   RARC N386 -  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   Group Code CO or PR (Patient Responsibility) dependent upon liability. (Use PR when the GA modifier is appended to the line item).                                                      MSN 09.040 -  This item or service was denied because information required to make payment  was incorrect.                                                                 MSN 15.20 -  The following polices were used when we made this decision: NCD 110.24.   Spanish Version  Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24.  --When denying claims for covered CAR T -cell therapy procedures because they do not contain new modifier -LU, use the following messages:   CARC 4 - The procedure code is inconsistent with the modifier used. Usage: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.                                                                                                                              RARC N386 - This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   Group Code CO   MSN 15.20 - The following polices were used when we made this decision: NCD 110.24.   Spanish Version  Las siguientes polticas fueron utilizadas cuando se tom esta decisin: NCD 110.24.  --When denying claims for covered CAR T -cell therapy procedures because the fractional units exceed 1 unit, use the following messages:   CARC 151 - Payment adjusted because the payer deems the information submitted does not support this many/frequency of services.   Group Code CO   MSN 15.060 - The information provided does not support the need for this many services or items within this period of time.   Spanish Version - (La informacin proporcionada no confirma la necesidad de estos servicios o artculos en este periodo de tiempo.)  -- Contractors shall reject claims for allogeneic CAR T -cell therapy ICD -10-PCS codes XW033G7 and XW043G7 and autologous CAR T -cell therapy ICD -10-PCS codes XW033C7 and XW043C7 when not billed for clinical trials under NCD 310.1 with the NCT number for the specific trial, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after October 1, 2021, using the following messages: