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Latest from Foley & Lardner LLP

On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022, eliminated the “DATA-Waiver Program”. The removal of the DATA-Waiver (or X-waiver) will increase the pool of practitioners eligible to prescribe buprenorphine, a clinically-proven medication used to treat patients with opioid use disorder (OUD). The Substance Abuse and Mental Health Services…
With 2022 closed, there is growing anticipation (trepidation?) about what is in store for digital health in the new year. Will venture funding trickle or will 2023 see more liquidity in the markets?  What legal and policy changes can we expect to see?  And how will the end of the Public Health Emergency (PHE) waivers affect telemedicine services and patient care? In a recent episode of the Slice of Healthcare podcast, Nathaniel Lacktman sat…
As part of the $1.7 million omnibus spending bill that became law December 29, 2022, the Centers for Medicare & Medicaid Services (CMS) extended, through December 31, 2024, the Acute Hospital Care at Home (H@H) initiative whereby individual hospitals may seek waivers to operate H@H programs. The industry had been anticipating this development since the spring of 2022 because, without an extension, these programs would no longer receive Medicare (and likely Medicaid) reimbursement once the…
The Consolidated Appropriations Act of 2023 (2023 CAA) further extends the HSA safe harbor allowing high deductible health plans (HDHPs) to offer first dollar coverage of telehealth services without ruining HDHP members’ ability to make or receive pre-tax contributions into their health savings accounts (HSAs). In other words, HDHP plans can continue to waive the deductible for any telehealth services without causing members to lose HSA eligibility. This relief was set to expire on December…
Many of the telehealth flexibilities that became popular with both patients and clinicians during the COVID-19 pandemic will expire when the public health emergency (PHE) ends. After three years of operating under these waivers, an abrupt ending to them could cause significant disruption to telemedicine providers and the patients who depend on their care, a concern referred to as the “Telehealth Cliff.”  And yet, the threat of the Telehealth Cliff can be solved through simple…
Analysis by Julie Dautermann, Competitive Intelligence Analyst This update helps automotive suppliers inform their legal and operational decisions to help address challenges and opportunities. Contact your Foley relationship partner, or Ann Marie Uetz, Vanessa L. Miller, or Nicholas J. Ellis, to follow up. Key Developments Foley & Lardner provided an overview of recent developments in design patent protection for automotive component parts. Projections for 2023 U.S. new light-vehicle sales are in the range…
The American Hospital Association (AHA), on behalf of its nearly 5,000 member hospitals and health systems, sent a letter urging the Drug Enforcement Agency (DEA) to take immediate action to allow telemedicine prescribing of controlled substances before the Public Health Emergency (PHE) waivers expire. The letter exhorts the DEA to publish the proposed rule for a special telemedicine registration, something the DEA has said it would do since 2009 (yes, 13 years ago; not a…
With the holiday season approaching, employers should be mindful that office holiday parties can create HR headaches. As pandemic restrictions have declined, employers are eager to host, and employees are eager to attend, in-person social events. However, a number of employment laws could be implicated from a holiday party gone wrong. Consequently, employers should keep these statutes top-of-mind this holiday season. Title VII of the Civil Rights Act of 1964: Be Merry, but Stay Away…
In this episode of Health Care Law Today, Nate Lacktman and Maureen Stewart are joined by Mark Josephs, Deputy General Counsel of LifeMD to discuss the current regulatory and legal environment for telemedicine companies regarding online subscription services, and the recent investigations by the federal government of these services. We encourage you to listen to the podcast in its entirety. Bios Nathaniel (Nate) Lacktman is a partner and chair of the firm’s national Telemedicine…
On October 11, 2022, the U.S. Department of Homeland Security (DHS) and U.S. Immigration and Customs Enforcement (ICE) announced an extension through July 31, 2023 of Form I-9 remote verification flexibilities first announced in March 2020 and later updated in March 2021. The March 2020-announcement, issued in response to COVID-19 public health guidance and precautions, enabled DHS to exercise prosecutorial discretion to defer physical presence requirements for the Form I-9, Employment Eligibility Verification under Section…