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August Medicare Coverage Update - CAR-T Therapy

Published on 

Tuesday, August 13, 2019

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On August 7, 2019, CMS released a Final Coverage Decision Memorandum concerning CAR-T Therapy for Cancers.  Per the memo, 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 either an FDA-approved indication (according to the FDA-approved label for that product), or
  • Used for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

The policy also continues coverage for routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1.

According to an FDA website “A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. … REMS are designed to help reduce the occurrence and/or severity of certain serious risks, by informing and/or supporting the execution of the safe use conditions described in the medication's FDA-approved prescribing information.”  Certain REMS may require providers to enroll in the REMS, complete training, document counseling of patients, enroll patients, perform monitoring, and/or document compliance with certain safe use conditions. The requirements for a specific drug can be found on the FDA website.

Remember that Decision Memos are not binding on contractors until they have been manualized as a National Coverage Determination (NCD).  Be on the lookout for a Medicare transmittal announcing the NCD and any associated claim instructions. The transmittal(s) will include effective and implementation dates for the new coverage rules.

Article Author: Debbie Rubio, BS MT (ASCP)
Debbie Rubio, BS MT (ASCP), was the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc. Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system. In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers.

This material was compiled to share information.  MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.