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April 17, 2020

Healthcare fraud warning from the Massachusetts U.S. Attorney arising out of COVID-19

U.S. Attorney for the District of Massachusetts, Andrew Lelling, publicized on April 17, 2020, his letter to Massachusetts hospitals urging them to report companies and individuals suspected of healthcare fraud, according to today’s Daily Digest Bulletin from his office. Lelling’s letter and his office’s announcement highlight and reiterate that healthcare and other fraud, both civil and criminal, arising out of the COVID-19 virus will be a key priority now and going forward at the state and federal level.

The announcement added that, “[i]n light of the COVID-19 pandemic, my office is prioritizing the investigation and prosecution of wrongdoing related to the COVID-19 pandemic, including those engaged in hoarding and/or price-gouging with regard to critical medical supplies,” said United States Attorney Lelling.

The following items are deemed “critical” medical supplies pursuant to section 102 of the Defense Production Act (50 U.S.C. § 4512) and Executive Order 13190 of March 23, 2020 (Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID-19):

N-95 Filtering Facepiece Respirators; other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100); elastomeric, air-purifying respirators and appropriate particulate filters/cartridges; powered Air Purifying Respirator (PAPR); portable Ventilators, including portable devices intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas; drug product with active ingredient chloroquine phosphate or hydroxychloroquine HCl; sterilization services for any device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act and sterilizers as defined in 21 CFR 880.6860, 880.6870, and 880.6880, including devices that already have FDA marketing authorization and those that do not have FDA marketing authorization but are intended for the same uses; disinfecting devices intended to kill pathogens and other kinds of microorganisms by chemical means or physical means, including those defined in 21 CFR 876.1500, 880.6992, and 892.1570 and other sanitizing and disinfecting products suitable for use in a clinical setting; medical gowns or apparel; PPE face masks, including any masks that cover the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels; PPE surgical masks, including masks that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials; PPE face shields, including those defined at 21 CFR 878.4040 and those intended for the same purpose; PPE gloves or surgical gloves; ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories as those terms are described in FDA’s March 2020 Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health.


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