radar Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry
DOJ recently announced a massive coordinated effort with other federal agencies to charge 345 defendants allegedly responsible for over $6 billion in fraud. DOJ, OIG, FBI, DEA, and various US Attorneys’ Offices in 51 federal districts teamed up to unveil charges against more than 100 doctors, nurses, and licensed clinical personnel.
Our labor and employment team recently posted a LawFlash to discuss the US Department of Labor (DOL) rule change related to how prevailing wages for permanent labor certifications and labor condition applications are determined.
In recent years, reports have indicated robust enforcement activities by the US Department of Labor (DOL) against ERISA plans and service providers to those plans. These enforcement activities have an increasing focus on ERISA group health plans and their service providers, such as health insurers and administrators.
We are pleased to announce that Morgan Lewis partners Nancy Yamaguchi and Janice Logan are organizing and participating in the US-Japan Healthcare Connections’ MedTech Emerging Growth Companies 2020 Virtual Roadshow.
Our corporate and business transactions and finance teams published a LawFlash on the Small Business Administration’s (SBA) recent procedural notice to Paycheck Protection Program (PPP) lenders addressing the treatment of PPP loans in the context of a “change of ownership” of the borrower and whether prior SBA approval must be obtained in such transactions. This LawFlash provides key takeaways for healthcare clients and healthcare industry investors with respect to M&A transactions involving PPP borrowers.
We invite you to join our labor and employment team on October 1 at 12:00 pm ET for a virtual roundtable on labor-management relations as they relate to the healthcare industry. 2020 has brought a myriad of uncertainties, especially for the healthcare industry, and we anticipate that clients may have a number of questions on how to handle these unprecedented times. The Morgan Lewis team, joined by IRI Consultants, will discuss how to address a number of labor-management-related issues today, tomorrow, and beyond.
As we continue to move away from a stifling summer and further into the busying fall season, be sure to catch up on August’s hot topics and must-reads from Health Law Scan and on-demand replays of recent webinars.
Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.
In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals, in spite of the federal about-face that has caused confusion concerning that same reporting since the inception of the pandemic.
We are pleased to announce that we are participating in three upcoming digital health events.