(Medicare Claims Processing Manual)

Inpatient  The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment: For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity -Diagnosis Related Group (MS- DRG).  For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost.  Outpatient  The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment: For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS. For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost.  For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge).   HOPDs may report CPT codes 0537T, 0538T, and 0539T to allow tracking of these services when furnished in the outpatient setting. Medicare will reject these lines as Medicare does not separately pay for these services under the OPPS.  These following scenarios present further clarification on how to report items and services related to CAR -T in various clinical scenarios.  Scenario 1: CAR -T Dosing and Preparation Services and Viable T -cells Administered in HOPDs : In instances when you administer the CAR -T drug in the HOPD setting, report CPT code 0540T for the administration and HCPCS Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), C9076, or, if a more specific code is unavailable, the most appropriate unclassified drug code (e.g., C9399 for unclassified drugs or biologicals). NOTE : the drug codes will be denied as a Part A service even if billed with the administration.) 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: R egulations -and-Guidance.Ch26. As discussed in the Calendar Year (CY) 2019 OPPS/Ambulatory Surgery Center final rule (83 FR 58904), the procedures described by CPT 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and prepar ation) represent the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the OPPS. However, you may report the charges for these various steps to collect and prepare the CAR T -cells separately and Medicare will reject them on the HOPD claim, or they may be included in the charge reported for the biological. Note : When including the charges for collection and preparation of the CAR T -cells in the charge for the CAR -T product, outpatient providers should code the CAR -T product service on the date that the CAR -T administration took place and not on the date when the  cells were collected.  Scenario 2: CAR -T Dosing and Preparation Services Administered in HOPD Setting, but Viable T -cells Not Administered:  In instances when the CAR -T drug is not ultimately administered to the beneficiary, but the CAR -T preparation services are initiated or performed in the HOPD facility, the hospital may not report the drug Q code (which only applies when the T -cells are adm inistered in the HOPD setting). HOPDs may report CPT 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.  Scenario 3: CAR -T Dosing and Preparation Services Administered 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 may not report the drug Q code (which only applies when the T -cells are administered in the HO PD 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 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.  Physician Office or Non -Hospital Clinic  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 Dosing and Preparation Services and Viable T- cells Administered in Physician Office or Non -Hospital Clinic : In instances when you administer the CAR-T drug 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 HCPCS Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), C9076, 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 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 reject them on the professional claim. Note : Practitioners should code the CAR- T product service on the date that the CAR -T administration took place and not on the date when the cells were collected.  Scenario 2: CAR -T Dosing and Preparation Services Administered in Physician Office or Non -Hospital Clinic, but Viable T -cells Not Administered:  In instances when the CAR -T drug is not ultimately administered to the beneficiary, but the CAR- T preparation services are initiated or performed in the physician office or other non- hospital clinic facility, the practitioner may not report the drug HCPCS code (which only applies when the T- cells are administered in the setting). The practitioner may report CPT 0537T, 0538T, and 05(Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23)  Inpatient   The A/ B MAC billing requirements will allow for CAR T -cell therapy when the services are submitted on the following TOB: 11X. Type of facility and setting determines the basis of payment:   For services performed in inpatient hospitals, TOB 11X, under the Inpatient PPS is based on the Medicare Severity-Diagnosis Related Group (MS- DRG).   For services performed in Critical Access Hospital (CAH) inpatient TOB 11X, payment is based on 101% of reasonable cost.  Outpatient   The A/B MAC billing requirements will pay for CAR T -cell therapy when the services are submitted on the TOBs: 13X and 85x. Type of facility and setting determines the basis of payment:   For services performed in hospital outpatient departments (HOPDs), TOBs 13X, or inpatient ancillary TOB 12X, payment is based on OPPS.   For services performed in CAH OPDs, TOB 85X, payment is based on reasonable cost.   For services performed in CAH Method II with revenue code 096X, 097X, and 098X, TOB 85X, payment is based on the lesser of the actual charge or the Medicare Physician Fee Schedule (115% of the lesser of the fee schedule amount and submitted charge).   HOPDs may report CPT codes 0537T, 0538T, and 0539T to allow tracking of these services when furnished in the outpatient setting. Medicare will reject these lines as Medicare does not separately pay for these services under the OPPS.   These following scenarios present further clarification on how to report items and services related to CAR T -cells in various clinical scenarios.   Scenario 1: CAR T -cell Dosing and Preparation Services and Viable T -cells Administered in HOPDs:   In instances when a physician or non- physician provider administers the CAR T -cell product in the HOPD setting, report CPT code 0540T for the administration.  The HOPD reports CAR T -cell product HCPCS code Q2041, Q2042, Q2053 (effective April 1, 2021), C9073 (prior to April 1, 2021), Q2054 (effective October 1, 2021), C9076 (prior to October 1, 2021), Q2055 (effective January 1, 2022), C9081 (prior to January 1, 2022), Q2056 (effective October 1, 2022), C9098 (prior to October 1, 2022), or, if a more specif ic code is unavailable, the most appropriate unclassified drug code (e.g., C9399 for unclassified drugs or biologicals). 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.   As discussed in the Calendar Year (CY) 2019 OPPS/Ambulatory Surgery Center final rule (83 FR 58904), the procedures described by CPT codes 0537T (collection/handling), 0538T (preparation for transport), and 0539T (receipt and preparation) represent the var ious steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the OPPS. However, you may report the charges for these various steps to collect and prepare the CAR T -cells separately and Medicare will reject them on the HOPD claim, or they may be included in the charge reported for the biological.  Note:  When including the charges for collection and preparation of the CAR T -cells in the charge for the CAR T -cell product, outpatient providers should code the CAR T -cell product service on the date that the CAR T -cell administration took place and not on the  date when the cells were collected.   Scenario 2: CAR T -cell Dosing and Preparation Services in HOPD Setting, 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 -cell preparation services are initiated or performed in the HOPD facility, the hospital shall not report the CAR T -cell product HCPCS code (which only applies when viable T -cells are administered). HOPDs 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.   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.