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.)
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.
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.
Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In Singapore, telehealth providers are mainly focused on providing remote telemedicine and/or on-demand house call services.
We invite you to join us on Tuesday, August 25 for our next installment of the Fast Break series, this time focused on fraud enforcement following the coronavirus (COVID-19) pandemic.
Our labor, employment, and benefits team recently posted a LawFlash on the ruling in federal district court in New York that invalidated significant parts of a US Department of Labor rule. The ruling found that more employees are eligible for up to 12 weeks’ coronavirus (COVID-19)-related emergency paid sick leave and emergency paid FMLA leave. In light of the court’s decision, employers should consider whether they need to adjust their leave determinations in light of the court’s decision.
Imagine you are the primary caretaker for your 94-year-old terminally ill mother who lives in your home while under hospice care during the coronavirus (COVID-19) pandemic.
Overwhelmed, exhausted, and drained—or even exposed to COVID-19—you discuss caregiver break with the hospice social worker who suggests “respite stay” for your mother but says Medicare only covers respite services up to five days, and only when care is furnished in an inpatient facility, like a nursing home. You don’t want that option given your mother’s heightened risk of contracting COVID-19 in a facility.