Health Care

Private equity ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. This post highlights the top five takeaways related to the proposed regulations for private equity companies or real estate investment trust ownership.

Deal structure is the foundation of a health care transaction. This post offers practical tips and hypothetical case studies for laying the groundwork for a successful health care transaction.

There has been a lot of discussion of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023, but we should also take a moment to review last year’s actions and policy updates on digital health from the Food and Drug Administration (FDA). The year 2022 marked the conclusion of the five-year Software Precertification Pilot Program and the release of the final Clinical Decision Support Software guidance, among other things (both described below); however, major digital health policy updates and announcements were few and far between. In this post, we summarize the agency’s key actions in the digital health space in 2022.

The vast majority of False Claims Act recoveries in fiscal year 2022 came from health care–related cases, and new case filings remained high, despite an ongoing decline in health care FCA case volume. Mintz’s Health Care Enforcement Defense team explores FCA litigation trends using annual DOJ statistics and activity tracked in our database of health care whistleblower cases.

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently partnered with various law enforcement agencies in a multi-state enforcement action aimed at uncovering a nursing degree fraud scheme: Operation Nightingale. This blog post discusses the related enforcement actions surrounding the fraud scheme and the broader implication on healthcare. 

The Stark Law’s Self-Referral Disclosure Protocol (SRDP) will include a new Group Practice Information Form for physician practices to report any noncompliance arising from not fully satisfying the Stark Law’s definition for a “group practice,” effective March 1, 2023. The Centers for Medicare & Medicaid Services (CMS) intends for the changes to reduce regulatory burden and streamline the disclosure process.

As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims Act (FCA) and the Civil Monetary Penalties Law. Though this proposal purportedly ensures that a lack of “reasonable diligence” cannot create civil liability, it would create significant confusion as to how CMS expects providers and Medicare Advantage organizations (MAOs) to “identify” and quantify potential overpayments before triggering the 60-day period to refund them. The proposed rule, if adopted, would likely become part of the framework for the Department of Justice and Department of Health & Human Services’ Office of Inspector General when evaluating potential liability for the alleged failure to return overpayments.

The COVID-19 Public Health Emergency (PHE), which was originally declared nearly three years ago, has been renewed through April 2023. As we’ve previously covered, the PHE allowed federal and state regulators to relax certain telehealth requirements, which has led to a rapid expansion in the availability of telehealth services. The Biden Administration has committed to provide at least 60 days’ notice prior to terminating the PHE or allowing it to expire, but several news outlets are reporting that this could be the final extension.