Legal and practical healthcare information.
The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for “remuneration.” In a recent decision by the Sixth Court of Appeals, the Court found that a hospital’s decision not to hire an …
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Health Canada determined that Texas-based LE-VEL BRANDS, LLC (“Le-Vel”), broke the law by selling its weight loss products to Canadians without seeking product licenses for their natural health products. The products had been distributed in Canada for some time, and Health Canada had flagged no health concerns. In deciding to issue a stop-sale order, Health Canada relied upon …
Continue reading “U.S. Marketing Materials Can and Will Be Used Against You in a Canadian Court”
Originally published in Healthcare Michigan, Volume 40, No. 3 As the year 2020 began, it would have been difficult for most Americans to imagine how life, as we knew it at that time, would change in the coming months and years. You likely recall generally, if not specifically, that on January 31, 2020, the Secretary of …
Continue reading “Keep the End in Sight: Expiration of the COVID-19 Declared Emergencies”
Originally published in Healthcare Michigan, Volume 40, No. 2 Non-compete provisions are common in healthcare employment agreements. These provisions are designed to prohibit an employed or contracted provider from competing against the contracting entity by working for or starting a competing business within a certain geographic area for a set period of time. As the Michigan …
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The Substance Abuse and Mental Health Services Administration (SAMHSA) 2021 National Survey on Drug Use and Health estimated that 9.2 million people ages 12 and older had misused opioids in the past year.[1] Death by overdose continues to be a leading cause of injury-related death in the United States, with a nearly 15% increase in …
Continue reading “Breaking Down Barriers: Expanded Access to Medication for Opioid Use Disorder”
Originally published in Healthcare Michigan, Volume 40, No. 1 Merging with or acquiring healthcare entities can often be complex, with many competing considerations. As purchase price is contemplated, acquiring entities are not only evaluating the profits of the entity being acquired but also considering key employees and the value they provide post-closing. Key employees and …
Continue reading “Due Diligence Strategies: How Buyers Can Preserve Human Capital in Healthcare M&A”
Originally published in Michigan Healthcare Volume 39, No. 12 On December 2, 2022, the US Department of Health and Human Services (“HHS”) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a Notice of Proposed Rulemaking to modify portions of Part 2 of Title 42 of the Code of …
Continue reading “HHS Proposes Rule on Confidentiality of Substance Use Disorder Patient Records”
On November 28, 2022, the U.S. Department of Health and Human Services (HHS), through the Office of Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a Notice of Proposed Rulemaking to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 CFR Part 2. The “Part …
Continue reading “HHS Proposes Rule to Align Part 2 Substance Use Disorder Laws With HIPAA”
On November 1, 2022, the Centers for Medicare & Medicaid (CMS) under the United States Department of Health and Human Services (HHS) finalized changes that are projected to significantly expand access to behavioral health care services, among other things. CMS released a Behavioral Health Strategy in 2022, which included improving access to and quality of …
There’s a new sheriff in town, and they are looking to crack down on medical spas in Michigan. Medical spas offering minimally invasive cosmetic medical services have enjoyed increasing popularity in the State of Michigan and across the United States. But with great success comes greater scrutiny of the so-called “Wild West” of the healthcare …
Continue reading “Michigan Medical Spas: Is the Wild West No More?”