evekhm/cms_iom_500 huggingface dataset:
(Medicare Claims Processing Manual)
Professional claims for CAR T -cell therapy and related services are billed using the Form CMS -1500 or 837P following instructions in chapter 12 of this manual (www.cms.hhs.gov/manuals/104_claims/clm104index.asp).   Contractors shall pay professional claims for CAR T -cell therapy when the service is administered at a healthcare facility that is enrolled in the REMS program as a REMS participating site. Contractors shall use the CMS HCPCS Website for current HCPCS codes, https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS -Quarterly -Update, and the individual REMS facility websites noted at section 400.1.   Contractors shall create an edit that only allows CAR T -cell therapy services to be submitted by, or performed in, an FDA REMS approved facility when the line item has a - KX modifier appended. Note: When a provider submits a - KX modifier on CAR T -cell therapy services, they are acknowledging that the service is being submitted by or performed in an FDA REMS approved facility.   Contractors shall create an edit that only allows CAR T -cell therapy services when the line item has a - LU modifier appended in addition to a - KX modifier. Note: When a provider submits an    - LU modifier on a CAR T -cell claim, it informs the MAC that the service is fractionated. The total units shall not exceed 1 unit.   Contractors shall set up their systems to allow fractionated units on multiple claims for CAR T -cell products on the same DOS. These claims should suspend for proper adjudication of payment.   The total payment will be divided by 10 and the provider will need to bill in 0.1 unit fractions. The provider will need to bill a total of 10 fractional units to reach the total Medicare allowed payment amount.   Example: CAR T -cell product allowed payment $445,000:   0.2 units = $89,000.06 0.2 units = $89,000.00 0.2 units = $88,999.99  0.2 units = $88,999.98 0.2 units = $88,999.97  Note:  Contractors shall only pay up to 1 unit, anything exceeding 1 unit must be denied.
(Medicare Claims Processing Manual)
Note:  Contractors shall only pay up to 1 unit, anything exceeding 1 unit must be denied.    For CAR T -cell products when the dose exceeds the code descriptor, use HCPCS code J3490, J3590, or J9999 for the exceeded dosage. Include the CAR T -cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent.                            Example: CAR T -cell product with dose exceeded allowed payment $150,000:  0.5 units = $74,999.00 0.5 units = $75,001.00  For CAR T -cell products when the dose exceeds the code descriptor, the provider would bill a total of 1 unit of the Q code plus a total of 1 unit of the J code. For example, Q2041 Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T- cells. If the provider gives 300 million cells, they will bill:   Q2041 for 0.1 fraction $42,294.00 x10 for 200 million cells (total $422,940.00) J9999 for 0.2 fractions $42,294.00 x5 for 100 million cells (total $211,470.00)  NOTE: The FDA labels for CAR T -cell products state the maximum number of cells that are to be infused. The HCPCS code descriptors for Q2041, Q2042, Q2053, Q2054, Q2055, and Q2056 all align with the FDA label maximum number of cells that are to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare.  Contractors shall allow a -76 modifier (repeat procedure or service by same physician or other qualified healthcare professional) on subsequent claims billed on the same date of service to assist with preventing duplicate denials.    400.3 - Payment Requirements (Rev. 10891, Issued: 07-20-21, Effective: 08-07-19, Implementation: 09-20-21)
(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).
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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
(Medicare Claims Processing Manual)
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)
(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 -cells in various clinical scenarios.   Scenario 1: CAR T -cell Dosing and Preparation Services and Viable T -cells Administered in HOPDs:
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.  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:
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.
(Medicare Claims Processing Manual)
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.