CMS Withdraws Memo Concerning Blood Glucose Monitoring System and Provides New Draft Guidance

On November 21, 2014 CMS issued S&C 15-11 concerning the direction on off-label/modified use of waived blood glucose monitoring systems (BGMS) and attendant CLIA regulations concerning use of such systems.  The memo is being withdrawn in order to obtain more feedback on the use of waived BGMS and to provide more education on CLIA requirements.  The withdrawn memo are accompanied by new draft guidance, in red, that may be added to a future, re-issued memo.  In addition, CMS released two Q&A documents concerning CLIA and waived BGMS.  Click here for the S&C Memo, the first Q&A, and the second Q&A.