CMS Expands Access to CAR T-Cell Therapies Nationwide

The Centers for Medicare and Medicaid Services (CMS) will now provide “consistent and predictable” nationwide access to chimeric antigen receptor (CAR) T-cell therapies, according to CMS Administrator Seema Verma. This decision comes in the wake of last week’s announcement that CMS was increasing payments for CAR T-cell therapies from 50 percent to 65 percent.

Prior to this announcement, Medicare’s regional managers made coverage determinations related to this treatment, leading to confusion and inconsistencies.

In the recent announcement, the agency also said that hospitals will no longer be required to collect and report data on patient outcomes as part of the “coverage with evidence development” requirement, a move praised by the American Society of Hematology (ASH). ASH feared this requirement would prevent hospitals from providing CAR T-cell therapies. Instead, CMS will use information collected by the Food and Drug Administration (FDA) and National Cancer Institute (NCI). CAR T-cell manufacturers also will be required to conduct patient follow-up monitoring and report the outcomes of treatment. This data will then be stored in an NCI registry.

CMS also said it will expand its coverage to CAR T-cell therapies administered at health care facilities enrolled in an FDA-mandated safety program that focuses on special training to manage side effects of these therapies, potentially allowing treatment to be provided at outpatient facilities.

Source: The Washington Post, August 7, 2019.