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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that Medicare may cover medically accepted off-label uses for Food and Drug Administration 
(FDA) approved drugs used in an anti-cancer chemotherapeutic regimen. Medicare maintains a list of 
compendia which define if a use is medically accepted. The off-label use must be supported in one or more of 
these compendia or in published, peer-reviewed medical literature. An off-label use must be supported in one 
or more of the compendia and the use must not be listed as unsupported, not indicated, not recommended, or 
equivalent terms, in any of the compendia. An off-label use may also be determined by the carrier in the state 
to be reasonable and necessary. You can find these rules and the list of the Medicare-recognized compendia in 
the Centers for Medicare and Medicaid Services, Internet Only Manual, Publication 100-02, Medicare Benefit  
Policy Manual, Chapter 15, Section 50.4.5. 
 
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 hyperplasiawhen a cell divides faster than 
normaland dysplasiaa buildup of extra cells with abnormal shape and disorganization. 
 
A persons 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 systemimmunotherapyis 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. 
 
You can find this information in the National Coverage Determination (NCD) Chimeric Antigen Receptor 
(CAR) T-cell Therapy 110.24. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.