Health Law Scan

As the availability and variety of digital health tools continue to increase, evidence is also being presented that those tools are having a meaningful impact on health outcomes. In a recent blog post, members of our technology, outsourcing, and commercial transactions team dove into the findings of two reports, Digital Health Trends 2021: Innovation, Evidence, Regulation, and Adoption, offered by the IQVIA Institute for Human Data Science; and a report from the University of Michigan’s Institute for Healthcare Policy and Innovation’s Telehealth Research Incubator.

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.

The US Federal Trade Commission (FTC) recently voted to withdraw its approval of the Vertical Merger Guidelines (the 2020 VMGs), which, as we covered in the past, the FTC and Department of Justice (DOJ) issued over a year ago on June 30, 2020. The vote on September 15, 2021 to rescind the policy statement broke along party lines, with the three Democratic commissioners—Chair Lina Kahn and Commissioners Rohit Chopra and Rebecca Slaughter—outweighing their two Republican colleagues—Commissioners Noah Joshua Phillips and Christine S. Wilson.

Members of our healthcare team recently published a LawFlash discussing the announcement by the US Department of Health and Human Services (HHS) that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To that end, HRSA will disburse $17 billion in Phase 4 payments remaining from the CARES Act Provider Relief Fund (PRF) to a “broad range of providers” based on lost revenues and expenses between July 1, 2020 and March 31, 2021.

The US Department of Health and Human Services recently announced the establishment of the Office of Climate Change and Health Equity (OCCHE). Noting that the OCCHE is “the first office of its kind at the national level to address climate change and health equity,” the OCCHE will be tasked with assisting with regulatory efforts aimed at reducing greenhouse gas emissions and criteria air pollution throughout the healthcare sector.

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.

Substantial change is imminent for key labor law issues commonly affecting healthcare entities. Healthcare employers utilize handbooks and rules, implement property access controls, and engage in human resources investigations, for instance. All these areas, and more, are poised for change with the new Biden-Harris administration National Labor Relations Board (NLRB) general counsel memorandum, highlighting a swath of legal issues where the general counsel will litigate test cases to change the law.

In the complex world of Medicare reimbursement, there are a multitude of payment formulae, mathematical adjustments, and reimbursement calculations that translate congressional policy into operational payments for hospital providers. But sometimes the Centers for Medicare and Medicaid Services (CMS) doesn’t get the math right. Recently, the US District Court for the District of Columbia found that academic medical centers have been subject to one such calculation error that implicates the amount such teaching hospitals receive as payment in support of direct graduate medical education (GME). Milton S. Hershey Med. Ctr. v. Xavier Becerra, Civ. Action No. 19-2680 (May 17, 2021). Based on the court’s reasoning, teaching hospitals operating above their full-time equivalent (FTE) resident cap may have been systematically underpaid as a result of the regulatory payment formula for determining the weighted FTE amount of residents used to calculate the GME payment. Other hospitals have recently followed Hershey Medical into the DC District Court seeking similar decisions.

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.