In 2000, the Medicare program changed its long-term policy of declining to pay for “experimental treatments” and implemented a policy of paying for the “routine” elements of care in clinical trials on Medicare patients. The policy was riddled with ambiguities, and it’s never been clear what the limits of coverage were. This month, CMS has made two moves that seem to indicate a much greater willingness to fund clinical trials. On July 10, the agency announced its intention to revisit the 2000 Clinical Trials Policy, in order to clarify those ambiguities and make the policy more useful and intelligible to researchers. On July 12, CMS announced a revision of its “Guidance for National Coverage Determinations with Evidence Development.”
This revision, in part, makes it easier to obtain Medicare coverage for trials that are gathering data about new treatments. The law firm of McDermott, Will & Emery has a nice summary of what’s at stake in the re-opening of the Clinical Trials Policy here. The CMS Clinical Trials Policy page, with links to the policy and related documents, is here. A CMS press release dealing with (and linking to) the Guidance revision–and mentioning the re-opening of the Clinical Trials Policy–is here.
– Stephen Latham