(Medicare Claims Processing Manual)

Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.    N640 Exceeds number/frequency approved/allowed within time period.     Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line -item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present).     Contractors shall deny/reject claim lines with CPT 93668 when sessions have reached 73 sessions using the following messages:  MSN 15.20: The following policies NCD 20.35 were used when we made this decision.     Spanish Version  Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin.   (Part A only) MSN 15.19: Local Coverage Determinations (LCDs) help Medicare decide what is covered. An LCD was used for your claim. You can compare your case to the LCD, and send information from your doctor if you think it could change our decision. Call  1-800-MEDICARE (1 -800-633-4227) for a copy of the LCD.    Spanish Version -  Las Determinaciones Locales de Cobertura (LCDs en ingls) le ayudan a decidir a Medicare lo que est cubierto. Un LCD se us para su reclamacin. Usted puede comparar su caso con la determinacin y enviar informacin de su mdico si piens a que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1 -800-MEDICARE (1800- 633-4227).   CARC 119: Benefit maximum for this time period or occurrence has been reached.   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 PR (Patient Responsibility) assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32 with or without a GA modifier or a claim -line is received with a GA modifier indicating a signed ABN is on file)   Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line -item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present   Contractors shall deny claim line -items for SET, CPT 93668, when sessions have reached 73 sessions with or without the KX Modifier present using the following messages:   MSN 15.20: The following policies NCD 20.35 were used when we made this decision.   Spanish Version  Las siguientes polticas NCD 20.35 fueron utilizadas cuando se tom esta decisin.   (Part A only) MSN 15.19: Local Coverage Determinations (LCDs) help Medicare decide what is covered. An LCD was used for your claim. You can compare your case to the LCD, and send information from your doctor if you think it could change our decision. Call 1-800- MEDICARE (1 -800-633-4227) for a copy of the LCD.  Spanish Version - Las Determinaciones Locales de Cobertura (LCDs en ingls) le ayudan a decidir a Medicare lo que est cubierto. Un LCD se us para su reclamacin. Usted puede comparar su caso con la determinacin y enviar informacin de su mdico si piensa que puede cambiar nuestra decisin. Para obtener una copia del LCD, llame al 1 -800- MEDICARE (1800-633-4227).  CARC 119: Benefit maximum for this time period or occurrence has been reached.    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 PR (Patient Responsibility) assigning financial responsibility to the beneficiary (if a claim is received with occurrence code 32 with or without a GA modifier or a claim -line is received with a GA modifier indicating a signed ABN is on file)  Group Code CO (Contractual Obligation) assigning financial liability to the provider (if a claim line- item is received with a GZ modifier indicating no signed ABN is on file and occurrence code 32 is not present).  400 - Chimeric Antigen Receptor (CAR) T -cell Therapy  (Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23)  T-cells employ a number of mechanisms to fight abnormal cells such as cancer. One type of therapy that leverages the immune system, immunotherapy, is Chimeric Antigen Receptor (CAR) T-cell therapy. CAR T- cells have been genetically altered in order to impr ove the ability of the T- cells to fight cancer.  400.1 - Coverage Requirements  (Rev. 11721; Issued: 11-28-22; Effective: 01 -01-23; Implementation: 01-03-23)  Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T- cells expressing at least one CAR when administered at healthcare facilities enrolled in the Food and Drug Administration (FDA) risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act (the Act) section 1861(t)(2), i.e., is used for either an FDA -approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia. See Publication 100-03, National Coverage Determination (NCD) Manual 110.24 for complete coverage criteria. See the following websites  for specific REMS facility information:  Kymriah https://www.us.kymriah.com/treatment- center -locator   Yescarta https://www.yescarta.com/find -a-treatment -center    Tecartus  https://www.tecartus.com/hcp/treatment- center -locator   Breyanzi https://www.celltherapy360.com/locations   ABECMA https://www.celltherapy360.com/locations   CARVYKTI  https://www.carvyktihcp.com/treatment- centers    NOTE:  The use of allogenic  T-cells from healthy donors are not autologous CAR T- cell treatments and shall not be billed as autologous CAR T- cell treatments.    400.2 - Billing Requirements (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  Effective for dates of service on or after August 7, 2019, contractors shall pay for line -item professional claims from approved providers for the administration of autologous treatment for cancer with T -cells expressing at least one CAR with Current Proce dural Terminology (CPT) code 0540T.  Contractors shall not require the NCD 110.24 - KX modifier and diagnosis codes for clinical trials under NCD 310.1. These claims shall be billed with the NCT number for the specific trial, the -Q0 clinical trial modifier, and the Z00.6 clinical trial diagno sis code on the 0540T claim line effective for dates of service on or after August 7, 2019.   For Part A Outpatient (OPPS) contractors shall not require NCD 110.24 REMS facility and diagnosis codes for CAR T -cell therapy CPT code 0540T in clinical trials under NCD 310.1 billed with the NCT number for the specific trial, the -Q0 clinical trial modifier, condition code 30, value code D4, and the Z00.6 clinical trial diagnosis code effective for dates of service on or after August 7, 2019.  400.2.1 - A/B Medicare Administrative Contractor (MAC) (A) Bill Types  (Rev. 10891, Issued: 07- 20-21, Effective: 08 -07-19, Implementation: 09- 20-21)   Valid type of bills (TOBs) for billing inpatient CAR T -cell therapy services may include (but are not necessarily limited to): 011x  Inpatient Hospital 012x  Inpatient Ancillary Hospital  Valid TOBs for billing outpatient CAR T -cell therapy services may include (but are not necessarily limited to):   013x  Outpatient Hospital 085x  Critical Access Hospital   400.2.2 - A/B MAC (A) Revenue Code  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  The following Revenue Codes are used for billing inpatient and outpatient CAR T -cell therapy services:   0871  Cell Collection w/CPT code 0537T  0872  Specialized Biologic Processing and Storage  Prior to Transport w/CPT code 0538T  0873  Storage and Processing after Receipt of Cells from Manufacturer w/CPT code 0539T  0874  Infusion of Modified Cells w/CPT code 0540T  0891  Special Processed Drugs  FDA Approved Cell Therapy w/ Healthcare Common Procedure Coding System (HCPCS) codes Q2041, Q2042, C9073 (replaced with Q2053 April 1, 2021), C9076 (replaced with Q2054 October 1, 2021), C9081 (replaced with Q2055 January 1, 2022), C9098 (replaced with Q2056 October 1, 2022), or C9399  400.2.3 - A/B MAC Billing HCPCS Codes  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  The following HCPCS/CPT procedure codes are used for billing outpatient CAR T -cell therapy services:   HCPCS Code Q2041 for Axicabtagene Ciloleucel  HCPCS Code Q2042 for Tisagenlecleucel  HCPCS Code Q2053 for Brexucabtagene Autoleucel (effective April 1, 2021)  HCPCS Code Q2054 for Lisocabtagene Maraleucel (effective October 1, 2021)  HCPCS Code Q2055 for Idecabtagene Vicleucel (effective January 1, 2022)  HCPCS Code Q2056 for Ciltacabtagene Autoleucel (effective October 1, 2022)  HCPCS Code C9073 for Brexucabtagene Autoleucel (prior to April 1, 2021)  HCPCS Code C9076 for Lisocabtagene maraleucel (prior to October 1, 2021)  HCPCS Code C9081 for Idecabtagene Vicleucel (prior to January 1, 2022)  HCPCS Code C9098 for Ciltacabtagene Autoleucel (prior to October 1, 2022)  HCPCS Code C9399, J3490, J3590, or J9999 for unclassified drugs or biologicals when dose of CAR T -cell therapy exceeds code descriptor or when other CAR T -cell therapy obtains FDA approval but has not yet received a specific HCPCS code  CPT Code 0537T collection/handling* CPT Code 0538T preparation for transport*  CPT Code 0539T receipt and preparation*  CPT Code 0540T the provider (physician/NPP) procedure to administer CAR T -cells  * Procedure represents the various steps required to collect and prepare the genetically modified T -cells, and these steps are not paid separately under the Outpatient Prospective Payment System (OPPS)/Medicare Physician Fee Schedule (MPFS).   400.2.3.1  A/B MAC (B) Places of Service (POS)  (Rev. 11721; Issued: 11- 28-22; Effective: 01 -01-23; Implementation: 01 -03-23)  The following places of service (POS) are covered for CAR T -cells product HCPCS codes (Q2041, Q2042, Q2053-Q2056, J3490, J3590, and J9999):   11 (Office)  49 (Independent clinic)   Professional claims for the procedure to administer CAR T -cells (0540T) may include (but are not necessarily limited to):  11 (Office)  19 (Off Campus -Outpatient Hospital)  21 (Inpatient Hospital)  22 (On Campus -Outpatient Hospital)  49 (Independent Clinic)