WASHINGTON – The Senate has passed an amendment offered by U.S. Senators Benjamin L. Cardin (D-MD), and Sam Brownback (R-KS), supporting continued Medicare coverage of routine patient care costs associated with clinical trials.    The Senators offered the amendment to the Labor, Health and Human Services and Education Appropriations bill, which passed by a vote of  75 to 19.    

Since 2000, Medicare has covered the routine patient care costs associated with clinical trials that are federally funded or reviewed by agencies such as the National Institutes of Health.  Earlier this year, the Centers for Medicare and Medicaid Services (CMS) proposed a new, burdensome 13-step self-certification process for clinical trial sponsors to complete as a condition of Medicare coverage for these costs.

Senators Cardin and Brownback authored a letter co-signed by 17 senators urging CMS not to alter a “coverage policy that has worked well” in facilitating seniors’ enrollment in clinical trials.   The bipartisan letter emphasized that such trials have already undergone extensive scientific and ethical review to ensure scientific merit and quality design.   CMS later announced that it would not make changes “at this time” but would “continue to review all aspects of its clinical trial policy.”

Prior to the 2000, the lack of definitive Medicare policy on clinical trial coverage meant that seniors who could not afford laboratory charges and other fees were excluded from participation.  As a result, many patients were unable to receive treatments that provided the only hope of a cure, and medical researchers were deprived of important evidence regarding how certain drugs would affect the elderly population.

“Clinical trials have a proven track record of success for many Medicare beneficiaries who face serious illnesses, such as cancer,” said Senator Cardin. “We want to ensure that CMS fully understands that the Senate supports the current seniors continue to have access to life-saving clinical trials.”