Federal Court Blocks Enforcement of Some ACA Preventive Health Service Requirements: What Plan Sponsors Should Consider

In a March 2023 ruling, a Texas federal district court vacated all actions taken by the Departments of Labor (“DOL”), Health and Human Services (“HHS”), and Treasury (collectively, the “Departments”) to implement or enforce certain preventive care requirements under the Patient Protection and Affordable Care Act (“ACA”). Recently, the Departments released initial FAQ guidance addressing …

Clearing the J-1 Home Residency Hurdle: Four Ways to Waive the Home-Residence Requirement

Originally published in Healthcare Michigan, Volume 40, No.  4 J-1 status is a favorite for foreign nationals attending medical resident training programs in the United States. While there are many advantages to the J-1 visa category, one major obstacle remains for J-1 physicians who wish to continue working in the United States—the home residence requirement. Because …

Sixth Circuit Defines False Claims Standards

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 …

U.S. Marketing Materials Can and Will Be Used Against You in a Canadian Court

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 …

Keep the End in Sight: Expiration of the COVID-19 Declared Emergencies

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 …

Proposed Rules Could Mean The End Of Non-Compete Agreements

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 …

Breaking Down Barriers: Expanded Access to Medication for Opioid Use Disorder

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 …

Due Diligence Strategies: How Buyers Can Preserve Human Capital in Healthcare M&A

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 …

HHS Proposes Rule on Confidentiality of Substance Use Disorder Patient Records

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 …

HHS Proposes Rule to Align Part 2 Substance Use Disorder Laws With HIPAA

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 …