Response to Comments: Glucose Monitors – DL33822

During the 45-day comment period, which was open from 12/17/2020 through 01/30/2021, the DME MACs received a total of 26 comments* from 47 commenters. * This count refers to the total comments/submissions received on this proposed local coverage determination as of January 30, 2021. Note: The MACs review all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions from a mass-mailing campaign. This can result in discrepancies between this count and the number of responses to comments. Introduction to Responses The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed Glucose Monitors Local Coverage Determination (LCD). Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13: In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support: (1) removal of the coverage criteria requiring beneficiary use of a blood glucose monitor (BGM) and performing frequent (four or more times a day) testing in order to qualify for a continuous glucose monitor (CGM); and, (2) a change in CGM coverage criteria to allow qualification of individuals using multiple daily administrations of any insulin (including inhaled insulin, Afrezza).