The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective …
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It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations. An investor decided to make an investment in a Colorado company that was seeking to create a particular …
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Steven Shapiro wrote an article for Vitamin Retailer entitled, “Operating a Health Food Retail Establishment in the Age of Coronavirus.” The article covers the measures retailers have taken to respond to the pandemic, including selling hand sanitizers and gloves, as well as the dangers of making claims about products purported to cure COVID-19. It also …
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In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the form of certain suspended or waived requirements applicable to facilities licensed by the Office of People with Development Disabilities (OPWDD). By …
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There is no question that the COVID-19 pandemic has caused a shortage of personal protective equipment (PPE) and certain cleaning supplies. Although it may be tempting for manufacturers, suppliers and others with access to inventory or production of those products to use the supply shortage as a business opportunity, business owners should proceed with caution …
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Last week, the Supreme Court of the United States issued a decision in Kelly v. United States[1] that limits federal prosecutors’ ability to seek criminal charges for public corruption. The Kelly case concerns the 2013 “Bridgegate” scandal that resulted in the prosecutions of Bridget Kelly, Deputy Chief of Staff to former New Jersey Governor Chris …
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False Claims Act, Medical Necessity and Government Regulation of Medicine In recent years, much attention has been paid to what makes a claim “false” under the False Claims Act (“FCA”) when the underlying misconduct is based on the alleged lack of medical necessity for the services provided.  Bearing on this issue are Court of Appeals …
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The United States Department of Justice (DOJ) announced that it had reached an agreement with Blue Bell Creameries of Brenham, Texas, to permit the company to plead guilty to two misdemeanor counts of distributing adulterated ice cream in violation of the federal Food Drug and Cosmetic Act and pay a criminal fine and forfeiture amount …
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In 1969, noted economist Milton Friedman coined the term “helicopter money” to describe the monetary policy of injecting liquidity into the market, much like dropping money to people from helicopters, as an alternative to quantitative easing. The CARES Act, popularly referred to as the Provider Relief Fund is a “helicopter” that dropped a lot of …
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Marc Ullman published an article in Nutrition Industry Executive entitled, “The ABH Nature’s Products Recall – Lessons for Own Label Distributors.” Click here to read the article. …
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