Update on Challenge to Medicare Statement Regarding CGM

In December 2014, a challenge was filed against the statement in a Medicare Article that asserts a continuous glucose monitor (“CGM”) is “precautionary” for individuals suffering from diabetes.  On September 11, 2015, the Civil Remedies Division Administrative Law Judge ruled that the administrative record was insufficient to support the validity of the Local Coverage Determination/Local Coverage Article, and awarded the Aggrieved Party, a Medicare beneficiary, discovery against the relevant Medicare contractor NHIC.  On December 4, 2015, at the close of discovery, the Judge convened a conference and set forth a schedule that required the Medicare contractor to submit all documents and witnesses that it intended to introduce into evidence in defense of the LCD/LCA by January 15, 2016.  The Judge also required both parties to indicate dates within the next six months they were available for a hearing in the event he determines one is necessary.  The Medicare contractor did not submit a single document or offer a single witness in support of the statement that CGM is “precautionary.”  In contrast, the Aggrieved Party submitted copious published peer-reviewed studies, consensus statements, and other documentation showing CGM is not precautionary but is reasonable and medically necessary for individuals suffering from diabetes, and supplied six witnesses, including nationally and internationally recognized leaders in diabetes care, who are willing to testify regarding the clinical and scientific evidence supporting the clinical utility of CGM and the status of CGM as the standard of care.   The Aggrieved Party also submitted a Motion for Summary Judgment.  The Aggrieved Party is waiting for the Judge to (1) rule on the case without a hearing, particularly in view of the Medicare contractor’s failure to submit any evidence in support of the LCD/LCA, or (2) schedule a hearing.

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