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Legal Insights and Perspectives for the Healthcare Industry

The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients to “include provider applicants such as residential treatment facilities, chiropractors, and eye and vision providers that have not yet received Provider Relief Fund distributions.” The full list of providers eligible for PRF Phase 3 Payment application is listed on the HHS website, and HHS confirmed that these providers may apply “regardless of whether they accept Medicaid or Medicare.” (Read the announcement for more information.)

The coronavirus (COVID-19) pandemic has brought numerous changes and challenges to the healthcare industry. These disruptions have encouraged an increased need for innovation and the development of groundbreaking technology to meet the healthcare industry’s vulnerabilities. Do you have projects or solutions you would like to turn into a viable business for the long term?

Join us for a new and exciting series of webinars aimed at helping entrepreneurs kick off and grow their businesses.

These timely and engaging presentations will provide practical tips and address opportune topics that will be invaluable to entrepreneurs. We will structure the presentations in a discussion format, leaving plenty of time for questions and answers.

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. In its September 30 press release, DOJ asserts that the largest portion of the $6 billion in losses – 75% – is attributable to what it describes as “Telemedicine Fraud Cases.” At first blush, this is a headline-grabbing figure that suggests that the nascent Medicare telehealth industry is rife with fraudulent conduct. But, in peeling back the layers, are DOJ’s concerns really about telehealth or historic issues in healthcare and other industries?

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. Effective October 8, 2020, the DOL will use a new formula for computing prevailing wage levels, resulting in higher prevailing wage levels for all occupations in the Occupation Employment Statistics wage database. This LawFlash may be of interest to our healthcare industry readers.

Read the full LawFlash >>

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.

Please join us on October 21, 2020 at 12:00 pm ET as we discuss the following:

  • Background on the DOL’s regulation of and enforcement activities against such group health plans and providers
  • The DOL’s primary areas of focus in its investigations against such plans and providers, with an eye toward helping plans and providers avoid exposure in those areas
  • Helpful considerations for health plans and providers navigating DOL investigations

Register now >

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. This year’s virtual conference, to be held in the United States October 12-14, 2020, will introduce more than 20 emerging US medical technology companies to a broad audience around the globe.

The conference will provide thematically grouped presentations and virtual networking, giving attendees a unique insight into the latest developments in medical technology.

We are honored to be a founding partner of the US-Japan Healthcare Connection – Conference Organizer.

Visit the conference website for more information and to register >>

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.

Read the LawFlash >>

Readers may also be interested to read our LawFlash on California Could See Regulatory Scrutiny of Post-COVID-19 Healthcare Transactions.

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.

Topics will include:

  • How organized labor is leveraging current events to achieve their organizing and policy goals
  • Collective bargaining challenges during the pandemic
  • The importance of contract language as exposed by the coronavirus (COVID-19) pandemic
  • Dealing with the practical and PR challenges of PPE demonstrations
  • Important NLRB case takeaways
  • Latest on COVID-19 mail-in ballot versus manual election developments

If you are interested in attending, please contact Margaret Butler. Register soon, as space is limited.

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.

Read the full LawFlash >>