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National Coverage Determination (NCD)

Chimeric Antigen Receptor (CAR) T-cell Therapy

110.24

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Tracking Information

Publication Number
100-3
Manual Section Number
110.24
Manual Section Title
Chimeric Antigen Receptor (CAR) T-cell Therapy
Version Number
1
Effective Date of this Version
08/07/2019
Ending Effective Date of this Version
Implementation Date
09/20/2021
Implementation QR Modifier Date

Description Information

Benefit Category
Drugs and Biologicals
Inpatient Hospital Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.
Indications and Limitations of Coverage

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
10891
Coverage Transmittal Link
https://www.cms.gov/files/document/R10891NCD.pdf
Revision History

08/2022 - Transmittal 11545 dated August 5, 2022, is being rescinded and replaced by Transmittal 11584, dated, August 31, 2022.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

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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.
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Chimeric Antigen Receptor (CAR) T-cell Therapy 1 08/07/2019 - N/A You are here
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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