Reimbursement Briefs: PillCam Reimbursement In Japan; 3-D Mammo Code Withdrawn; CMS Data Sharing

Given Imaging Ltd. announced Nov. 11 that Japan’s Central Social Insurance Medical Council, Chuikyo, has approved its PillCam COLON for reimbursement, based on a recommendation by the Japanese Ministry of Health, Labor and Welfare. As of Jan. 1, each PillCam COLON capsule will be reimbursed in Japan for 83,100 yen, or approximately $840.00. In December, the Japanese MHLW will determine the final indication for use for PillCam COLON, an ingestible capsule that provides images of the colon, as well as the amount for the professional fee. Japan’s Pharmaceuticals & Medical Devices Agency granted regulatory clearance for PillCam COLON in July.

PillCam COLON received a CE mark in 2006 and is available in Europe, Israel, Asia, Latin America, Canada and Australia. (See Also see "Given To Launch Next-Gen Colonoscopy PillCam In Europe In November" - Medtech Insight, 20 July, 2009..) FDA rejected the firm's 510(k) for the device in 2008, deeming it not substantially equivalent to any marketed device for visualization of the colon. (See [A#01340080016_b].) In August 2012, the Israeli firm announced plans to pursue 510(k) clearance for its PillCam Colon 2 video capsule for diagnostic imaging of the colon