radar Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry
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.
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.
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.
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.
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.
US President Donald Trump issued an executive order on August 3 that aims to expand telehealth access to Medicare beneficiaries beyond the coronavirus (COVID-19) public health emergency (PHE) period. The executive order focuses on rural healthcare providers in particular, noting the difficulties patients in rural areas face in obtaining accessible, high-quality healthcare services over the years.
The coronavirus (COVID-19) pandemic has created unforeseen and unavoidable circumstances within the healthcare industry that may provoke further crisis for hospitals, nursing homes, physicians, and other frontline healthcare providers in the form of potential liability claims for noncompliance with COVID-19 protocols or other standards.
The coronavirus (COVID-19) pandemic has brought a dramatic shift from in-person healthcare visits to telehealth services around the world, unveiling a new normal for providing healthcare services.
The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical Review Contractors, and Recovery Audit Contractors, including those under the Targeted Probe and Educate program, on August 3, 2020.