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.
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
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.
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.
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.
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.
- Morgan Lewis Lawyers Discuss Kazakhstan’s Health PPP Programme
- Tele-Tuesday: Singapore’s Telehealth Expansion
- LawFlash: Court Expands Employee Eligibility for COVID-19 Emergency Paid Sick and FMLA Leave
- As Prescribed: Executive Order on 340B Program Is Limited, Unlikely to Take Effect but Could Signal Future Changes
- LawFlash: Immigration Developments: Public Charge Rule and USCIS Filing Fees
- Respite Care Flexibility During the COVID-19 Pandemic – A Pragmatic Legislative Fix
- Tele-Tuesday: Executive Order Signals Increased Support for Telehealth Expansion
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.
CMS’s Interim Final Rule (IFR) applies to a large variety of healthcare and non-healthcare providers that are currently testing for coronavirus. Hospitals, employers, and other entities are struggling to ensure they comply with an ever-changing landscape of local, state, and federal reporting requirements. However, this recent IRF subjects these entities to fairly stout enforcement consequences for failure to stay current, comply, and perform. CMS released its IFR with comment for public display on August 25 with publication in the Federal Register on September 2, 2020. Comments are due 60 days after publication.
We are pleased to announce that we are participating in three upcoming digital health events.
Michele Buenafe, FDA partner and leader of our digital health initiative, will speak at two upcoming FDLI conferences focused on the Food and Drug Administration’s (FDA's) regulation of digital health and developments in digital health regulation before and beyond the coronavirus (COVID-19) pandemic, including significant enforcement discretion policies and exemptions FDA has implemented over the last six months.
- “Is My Digital Health Product a Medical Device?” during the Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA program on September 9
- “Regulation of Digital Health During and After COVID-19” during the Digital Health Technology and Regulation During COVID-19 and Beyond program on September 10
On our next Fast Break webinar, Jake Harper will discuss updates in telehealth, a topic that has been top of mind for so many healthcare companies amid the COVID-19 pandemic. Register for Fast Break now.
Don’t forget you can check out all of our latest healthcare events and publications on Our Thinking on Healthcare.