Thursday, December 1, 2022

Brief Blog: Legislation Proposed Would Corral NCDs About Drugs

Legislation aiming to alter Medicare's ability to regulate Part B drugs through NCD's is launched, on the heels of better results in an Alzheimer drug study in New England Journal.

Last year, Medicare published an NCD requiring very limited coverage (within clinical trials) of Alzheimer drugs based on beta-amyloid mechanisms.   The NCD was proactive, applying to future FDA-approved drugs not yet developed.  See the NCD here.   The NCD is now coming back into focus, as a new Alzheimer drug enters the FDA approval process, heralded by a study in NEJM here (Van Dyck et al.).

According to a news item in Fierce Healthcare, here, the Access to Innovative Treatments Act (AITA) will require CMS to evaluate new drugs individually.

Another example of a class-wide NCD is the one for CAR-T therapies, unchanged since 2019.

For some April 2022 coverage of the Aduhelm NCD, here and here.

The CAR-T NCD results in meticulously burdensome claims-processing instructions, updated regularly - here.