Removing Barriers to Clinical Research Act of 2016

Removing Barriers to Clinical Research Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to expand Medicare coverage of costs associated with clinical trials. Under current law, Medicare covers routine costs of care furnished to a beneficiary enrolled in a category A (experimental) clinical trial of a medical device intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The bill requires Medicare to also cover, with respect to a beneficiary enrolled in a category B (non-experimental) clinical trial, routine costs of care as well as the cost of the device under investigation.

A trial of a medical device shall, for purposes of Medicare coverage, be deemed to meet the definition of a category A or category B clinical trial, as the case may be, if the trial is conducted under the Federal Food, Drug, and Cosmetic Act's investigational use exemption.