Health Law Scan

The Biden administration recently announced its much-anticipated proposed rule for implementing a minimum staffing “floor” for nursing homes in the United States and further launched a nursing home accountability initiative. These efforts are seismic for the long-term care nursing home community and will bring new challenges and scrutiny to a health industry sector battered with healthcare personnel shortages, pandemic recovery obstacles, changing reimbursement models, and regulatory scrutiny.

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.

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.

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.

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.

We invite Health Law Scan readers to join us on Thursday, July 22 at 3:00 pm ET for our next installment of the Fast Break webinar series. For this month’s edition of Fast Break, we will be joined by healthcare litigation partners Katie McDermott and Howard Young to analyze the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory, a protracted suit filed under the qui tam provisions of the False Claims Act against the owner of a specialty clinical laboratory and the individuals who led its sales operation.

We hosted a very informative Fast Break session last week discussing what healthcare providers need to know as they prepare their employees to return to work and try to get back to a sense of normalcy. If you weren’t able to join us for the live program with Daniel Kadish, one of the leaders of Morgan Lewis's COVID-19 compliance and counseling team, be sure to access the presentation on demand or peruse the main takeaways below.