CMS Expands Coverage of CAR T-cell Therapy for Medicare Beneficiaries

August 8, 2019

The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor T-cell (CAR T-cell) therapy for certain patients with cancer.

CAR T-cell therapy uses a patient’s own white blood cells, which have been genetically reprogrammed in a lab to fight specific cancer cells. In 2017, FDA approved two CAR T-cell therapies to treat children and young adults with acute lymphoblastic leukemia and adults with diffuse large B-cell lymphoma. Researchers are also pursuing this approach in other types of cancer with promising results, especially in multiple myeloma. ASCO named CAR-T cell therapy the “Advance of the Year” in its Clinical Cancer Advances 2018.

As outlined in the NCD, Medicare will now:

  • Cover CAR T-cell therapies nationwide.
  • Provide coverage when CAR T-cell therapy is administered in inpatient facilities or in outpatient health care facilities that are enrolled in FDA risk evaluation and mitigation strategies (REMS) with expertise in delivering cellular therapies.
  • Cover CAR T-cell therapy for off-label uses that are recommended by CMS-approved compendia.

“ASCO applauds the Centers for Medicare & Medicaid Services (CMS) for releasing a national coverage determination (NCD) on CAR T-cell therapy that provides increased access to an innovative cancer treatment to Medicare beneficiaries nationwide," said ASCO President Howard A. “Skip” Burris III, MD, FACP, FASCO. "The determination is largely consistent with ASCO’s principles for CAR T-cell therapy coverage, which support coverage for all Food and Drug Administration (FDA)-approved indications of this treatment."

Earlier this month, CMS released the Hospital Inpatient Prospective Payment System (IPPS) final rule for fiscal year (FY) 2020, which included a new technology add-on payment (NTAP) for 18 technologies, including CAR T-cell therapy. CMS also increased the add-on payment from 50 to 65%, which brings the maximum add-on payment for CAR T-cell therapies to $242,450 (up from $186,500).

In comments submitted to CMS in June 2019, ASCO outlined its principles for the approval, coverage, and reimbursement of CAR T-cell coverage and urged CMS to establish an NTAP of at least 80%. 

Read the full national coverage determination.

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