radar Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry
In our latest Fast Break session and on the heels of recent announcements from the Biden-Harris administration and the US Food and Drug Administration’s (FDA’s) granting of full authorization for the Pfizer vaccine in August, we were joined by Dan Kadish, a Morgan Lewis labor and employment associate and one of the leaders of our Morgan Lewis COVID-19 vaccine task force, to discuss how these updates may impact employers in the healthcare industry.
We hosted a very informative Fast Break session last month on CMS telehealth and RPM updates. If you weren't able to join us, the session was led by healthcare litigation associates Jake Harper and Tesch West, with special guest Ben Steinhafel, director of policy and external affairs at the Center for Telehealth and eHealth Law.

Our immigration team recently published a LawFlash discussing the Centers for Disease Control and Prevention’s (CDC’s) new policy under which all applicants for a green card must be fully vaccinated against COVID-19. This resource may be of interest to Health Law Scan readers, as this policy will impact green card applicants in the healthcare sector.

Members of our labor, employment, and benefits team recently published a LawFlash discussing the Occupational Safety and Health Administration’s (OSHA’s) updated nonbinding COVID-19 guidance applicable to all industries not otherwise covered by the OSHA Emergency Temporary Standard.
In the most recent edition of our Global Healthcare Transactions Series, we focus on the Asia-Pacific region, which saw a wave of healthcare activity in 2020 including record high deals and a new peak for disclosed value. These gains can be attributed to macroeconomic trends such as aging populations and increasingly affordable healthcare, and favorable government policies encouraging local manufacturing and development of healthcare products.

A notable headline from the August 12 MLN Connects Newsletter for healthcare providers states “CMS Resumes Targeted Probe & Educate Program.” Designed to help providers reduce claim denials and appeals, CMS suspended prepayment reviews under the Targeted Probe and Educate (TPE) program in response to the COVID-19 public health emergency (PHE) in March 2020. But unlike post-payment audits which have been active since CMS authorized its contractors to begin new audits in August 2020, TPE prepay reviews remained on hold.

Members of our labor and employment and healthcare teams recently published a LawFlash covering the US Department of Justice’s (DOJ’s) definitive guidance which specifically concluded that “federal law does not prohibit public or private entities from imposing vaccination requirements for vaccines that are subject to emergency use authorizations from the U.S. Food and Drug Administration.”
The Centers for Medicare and Medicaid Services (CMS) recently released a table copy of its calendar year 2022 Medicare physician fee schedule proposed rule. The proposed rule is chock full of policy updates concerning telehealth, remote physiologic monitoring (RPM), and new remote therapeutic monitoring codes. Coming on the heels of the significant telehealth waivers put in place during the COVID-19 public health emergency (PHE), CMS proposes to continue the steady expansion of virtual care options with this rule.
We invite Health Law Scan readers to join members of our digital health team for a webinar set to discuss the various deal structures frequently used in digital health company seed financings, as well as the range of market terms for each.
Our healthcare team recently launched a publication series highlighting the global impact of COVID-19 on healthcare transactions. Around the globe, the healthcare industry has faced similar issues from the unprecedented pandemic, prioritizing their operational response to COVID-19. Now, as countries begin to reopen, healthcare entities may refocus on planning for long-term transformation of their business models. In this series, we will explore how the pandemic impacted healthcare transactions in specific regions and what we can expect in a post-pandemic world.