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CMS and FDA back medical device ID numbers for billing

Accreditation Insider, July 19, 2016

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On July 13, CMS and the Food and Drug Administration [FDA] sent a letter to Congress asking that all medical devices be given a unique ID number and that number be included in billing data and claims forms. Signed by CMS acting administrator Andy Slavitt and FDA commissioner Robert Califf, the letter says the benefits of such a system will:

•    Allow the FDA to quickly identify malfunctioning devices quickly and issue a recall if needed.
•    Aid in collecting and analyzing patient data for device surveillance and innovations.
•    Help calculate and compare the total costs and outcomes of each device.
•    Provide better information to link the patient and implanted device to help track rebates from manufactures back to the payer or provider.

 “[The Department of Health and Human Services] is committed to improving the quality and safety of health care provided to all Americans and believes that monitoring medical device product safety and performance is critical for ensuring public health and safety,” they write.

During the tainted endoscope scandal earlier this year, device identification [DI] numbers were proposed as a way of preventing and tracking infection sources. While a plan to add unique barcodes to medical devices is already being implemented, there had been resistance from lawmakers about adding DI’s to billing data. A Brookings Institution report last year said it could cost up to $250 million to implement and maintain a new billing system over the first five years, and many lawmakers worried about funding. Until this year, CMS had also been opposed the adding DIs to billing data based on cost.



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