Chimeric Antigen Receptor (CAR) T-cell Therapy

A.    General

Cancer is a collection of related diseases of dividing cells that can start almost anywhere in or on the body, evade the immune system, and invade nearby tissues. Categories of cancer are typically organized by the location in the body and specific type of cell. These categories may include carcinoma, sarcoma, leukemia, lymphoma, multiple myeloma, melanoma, and brain and spinal cord tumors. There are also changes to these cells that are not considered cancer. These changes include hyperplasia—when a cell divides faster than normal—and dysplasia—a buildup of extra cells with abnormal shape and disorganization.

A person’s immune system contains cells to help fight substances that are foreign to the body, including cancer. These cells are called white blood cells, most of which are lymphocytes. The two main types of lymphocytes are B lymphocytes (B-cells) and T lymphocytes (T-cells). B-cells generate and release antibodies to fight infection, especially bacterial infections, while T-cells employ a number of other 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 improve the ability of the T-cells to fight cancer. The genetic modification creating a CAR can enhance the ability of the T-cell to recognize and attach to a specific protein, called an antigen, on the surface of a cancer cell.

B.    Nationally Covered Indications

A.  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 chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security 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.

C.    Nationally Non-Covered

Effective for services performed on or after August 7, 2019, the use of non-FDA-approved autologous T-cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements in Section A are not met.

D. Other

Effective for services performed on or after August 7, 2019, routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1 will be covered.

(This NCD last reviewed August 2019.)

11/2020 - The purpose of the Change Request (CR) is to inform MACs that effective for claims with dates of service on or after August 7, 2019, CMS covers autologous treatment for cancer with T-cells expressing at least one CAR when administered at healthcare facilities enrolled in the FDA Risk Evaluation and Mitigation Strategies (REMS),and meets specified FDA conditions.

05/2021 - This CR Rescinds and Fully Replaces CR11783. (TN 10796) (CR12177)

07/2021 - Transmittal 10796, dated May 20, 2021, is being rescinded and replaced by Transmittal 10891, dated, July 20, 2021 to add CPT code C9076 for Breyanzi and the HCPCS website for reference to the policy section and in the 100-04 manual attachment. This correction also updates the implementation date and updates business requirements 12177-04.1, 12177-04.3, 12177-04.4 and 12177-04.8. This correction only revises publication 100-04, there are no changes to publication 100-03. All other information remains the same. (TN 10891) (CR12177)

08/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10963) (CR12399)

09/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11025) (CR12399)

10/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11068) (CR12480)

01/2022 - Transmittal 11068, dated October 21, 2021, is being rescinded and replaced by Transmittal 11179, dated, January 12, 2022 to revise the attachment for NCD 110.24, CAR-T, to add business requirement 12480.10.1 by adding generic unspecified procedure codes, to clarify coverage and claims processing in the policy section and to review the implementation date. All other information remains the same. (TN 11179) (CR12480)

02/2022 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.(TN 11264) (CR12606)

04/2022 - Transmittal 11264, dated February 10, 2022, is being rescinded and replaced by Transmittal 11342, dated, April 6, 2022 to (1) revise BR 12606.10 instructions for NCD 110.24, (2) BR12606.2, fix typo in NCD 160.18 spreadsheet ICD-10 G40.384, which should be G40.834, and, (3) revise implementation verbiage (no changes to the actual implementation date). All other information remains the same. (TN 11342) (CR12606)

04/2022 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11391) (CR12606)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates to specific NCDs. (TN 11545) (CR12822)

08/2022 - Transmittal 11545 dated August 5, 2022, is being rescinded and replaced by Transmittal 11584, dated, August 31, 2022. (TN 11584) (CR12822)