Effective January 1, 2014, CMS will require providers and suppliers to report an 8-digit clinical trial number on claims for items or services furnished pursuant to clinical trials that qualify for coverage as set forth in the Medicare National Coverage Determination Manual.  The reporting of this number is voluntary thru December 31, 2013. 

The clinical trial number that CMS is making mandatory is the number assigned by the National Library of Medicine (NLM) ClinicalTrials.gov website.  CMS uses this number to identify all items and services provided to beneficiaries during their participation in a study covered under coverage with evidence development (CED), the Medicare Clinical Trial Policy, or a CMS-approved investigational device exemption (IDE) study. 

CMS anticipates that the mandatory reporting will improve its tracking of Medicare payments, ensure that the information gained from the research is used to inform coverage decisions, and make certain that the research focuses on issues of importance to the Medicare population.

Providers and suppliers are required to implement the mandatory reporting by January 6, 2014.  The CMS transmittal discussing the mandatory reporting requirement is available here.

Reporters, Donna K. Thiel, Washington, D.C., +1 202 626 2393, dthiel@kslaw.com, Juliet M. McBride, Houston, +1 713 276 7448, jmcbride@kslaw.com.