News Briefs: April 24, 2023

In an April 20 MLN Connects, CMS reminds providers they are required to respond timely to additional documentation requests.[1]

The HHS Office of Inspector General (OIG) has updated its work plan and it includes an evaluation of “the use of remote patient monitoring services in Medicare,” which OIG said “has the potential to exponentially expand.”[2]

Greater Boston Behavioral Health LLC has agreed to plead guilty to a misdemeanor charge of violating the Food, Drug and Cosmetic Act (FDCA), paying a criminal fine of $657,678 and forfeiting $1,929,464 in connection with the administration of a misbranded drug, the U.S. Attorney’s Office for the District of Massachusetts said April 20.[3] “According to the criminal information, Greater Boston Behavioral Health sought out sources from which it could purchase Botox® that was packaged and labeled only for sale in the United Kingdom and other foreign countries. The label of the foreign Botox purchased by Greater Boston Behavioral Health differed from the FDA-approved label for Botox and Botox Cosmetic and lacked the designation ‘Rx Only’ as required by the FDCA for prescription drugs,” the U.S. attorney’s office said. “The label also typically did not include the FDA-required ‘black-box warning’ concerning potential side-effects of Botox.”

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