CMS’s initial payment codes for chimeric antigen receptor (CAR) T-cell therapies are opposed by the medical community on the basis that they would be cumbersome to implement and wouldn’t reflect the full amount of care delivered to each patient. CAR T-cell therapies, which can cost close to 0,000, are associated with ancillary care for hospitalization, observation, and treatment of adverse events, which can cause costs to climb much higher. Payment codes do not clarify how these services will be covered, manufacturers, clinicians, cancer facilities, and patient advocates say.
By contrast, with sipuleucel-T, blood cells are removed from patients and processed in a laboratory, but each infusion can be accomplished in a single office visit.
Those who testified Wednesday said it was unclear how costs for CART-cell therapy would be paid based on the CMS coding. They said that if other codes were intended to be used in conjunction with the Q codes assigned for CAR T-cell therapy, inevitable overlap would cause confusion and interfere with payment.
“We encourage CMS to take another deep look at what is involved in these services and what might have seemed like a good model to follow,” Jugna Shah, MPH, said on behalf of the Alliance of Dedicated Cancer Centers, which includes Dana-Farber Cancer Institute in Boston, Massachusetts, Fox Chase Cancer Center in Philadelphia, Pennsylvania, Memorial Sloan Kettering Cancer Center in New York, New York, and Moffitt Cancer Center & Research Institute in Tampa, Florida, among other large and prominent institutions.
A permanent decision on the coding for currently approved CAR T-cell therapies is expected no sooner than January 2019. In comments Wednesday, CMS officials acknowledged the difficulties projected that will result from the temporary Q-code assignments and indicated a willingness to make improvements. “We’ll work on looking at the code again,” an unnamed CMS official said during the hearing, which was broadcast over the Web. “Some of your comments indicated that we didn’t grasp what was going on in different settings.”
The application by Novartis for a revision of the temporary Q code assigned to its CAR T-cell therapy differs from the Kite Pharma application. Novartis seeks a higher dosage of CAR T cells incorporated into the wording. Current language specifies “up to 250 million car-positive viable T-cells” per infusion. This was based on the original CAR T-cell indication approved last year for B-cell precursor ALL that is refractory or in second or later relapse. The more recent, second indication for adult patients with relapsed or refractory large B-cell lymphoma requires infusion capability for up to 600 million modified T cells. The new wording, proposed by Novartis, would specify, a “minimum of 200,000 T cells.”
The CMS Q code wording for the Novartis product also incorporates leukapheresis and dose preparation but Novartis did not request to have those elements removed from the code
description. Asked why by a CMS official, John Coombs, primary speaker for Novartis, said that the company was aware of the concerns about payment complications. He requested that any changes made to the coding language for CAR T-cell products in general be consistent across the board.
Others who testified at the hearing added that consistency in wording and coding language that correctly addresses payment issues would become increasingly important as more CAR T-cell applications are introduced.
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