The CMS on Friday on whether to cover a pricey, breakthrough cancer treatment.
Although Friday marked the agency's deadline for its national coverage determination decision, the CMS did not elaborate on why it decided to hold off. Chimeric antigen receptor T-cell therapy, or CAR-T, is an immunotherapy cancer treatment.
The agency did not immediately respond to a request for comment, but said in the announcement that a decision would be forthcoming.
The proposed coverage determination released in February has received stiff pushback from hospitals and cancer centers. Some cancer centers were not happy that the proposal restricted coverage of CAR-T to only hospitals. While current treatments are administered only in a hospital because of toxic side effects, some drugmakers are studying administering it in outpatient settings.
So far, two CAR-T treatments are on the market: Novartis' Kymriah, which costs $475,000, and Gilead Sciences' Yescarta, which costs $373,000. CAR-T works by boosting the patient's immune system to attack cancer cells.
Several hospitals also said that the CMS won't factor in added costs for facilities when providing CAR-T, including administrative and training costs. Taken together with the already high cost of the drugs, a trip to the hospital for CAR-T could cost a patient nearly $1 million.
Treatment with a CAR-T drug currently requires a median 15-day hospital stay that costs more than $80,000, according to an analysis from the healthcare consulting firm Vizient.
Currently a local Medicare administrative contractor decides whether to cover CAR-T. A national determination would have required Medicare to pay for the pricey treatment.
Meanwhile, commercial coverage insurers often will decide on whether to cover CAR-T on a case-by-case basis.