It’s no secret that the Department of Justice has made the False Claims Act (“FCA”) a priority for years. Last month, we discussed why regulatory changes in response to Covid-19 (e.g., STARK waivers) could provide additional bases for the government to bring FCA cases. This post addresses the basics of cooperation credit for defendants who cooperate with the Department of Justice during an FCA investigation.
As landlords and tenants continue to navigate the uncertainties of traditional office and retail properties in the era of COVID, one asset type that has emerged as more resilient in this new environment is life science real estate. The spaces utilized by biotech and pharmaceutical companies, as well as medical research facilities, are highly technical, with site-specific functionality that cannot be replicated by remote work environments. As a result, life science real estate continues to attract tenants and property owners continue to invest in this sector. However, utilization of space for life science uses—wet and dry laboratories, warm rooms and cold rooms, and other activities—presents a number of specific issues for both tenants and landlords that should be considered in any lease transaction. Below is a summary of some of those issues from both a tenant’s and a landlord’s perspective.
How do you take a negative and turn it into a positive? COVID-19 has made answering this question very difficult, as the pandemic continues to have a negative and in some cases long lasting and devastating impact on people’s daily lives and the many businesses that help sustain daily living. One area of business that has been hit particularly hard, as a result of the pandemic, has been the hospitality industry. According to a new national report completed by Trepp , the hotel industry is facing an unprecedented number of foreclosures as the COVID-19 pandemic continues to devastate small business hotel owners and its workforce. More specifically, American Hotel & Lodging Association (AHLA) conducted a survey of more than 600 hotel owner respondents and more than half of them stated that they are in danger of losing their property to foreclosure by commercial real estate lenders due to COVID-19. As a result of these market conditions, some senior living developers and operators see a growing opportunity to capitalize on the hotel foreclosures by converting them to assisted living facilities. However, turning this negative into a positive won’t go without its challenges, and developers and owners should be mindful of some pitfalls when attempting to make this conversion a reality in Texas.
This article examines the different types of preferential rights in ground leases for medical office buildings, and examines strategies in drafting preferential rights provisions to protect the interests of both ground lessors and ground lessees. Ground leases are a popular way for hospitals and health systems (collectively, “Hospitals“) to maintain ownership and control of their hospital campus, while also allowing them expand their campuses or monetize equity tied up in Hospital-owned buildings. Typically, a ground lessee (or, the “MOB Owner“) is either a developer of, or investor in, medical office buildings (“MOBs“) who either develops the MOB or acquires an existing MOB from the Hospital and then subleases space within the MOB to physicians, physician groups or the Hospital itself. Under a ground lease, typically the MOB Owner holds a leasehold interest in the real property and owns fee title to the building and other improvements located thereon for the term of the ground lease, and upon the expiration of the ground lease, title to the improvements reverts to the Hospital.
The U.S. Department of Health and Human Services (HHS) recently finalized transformative rules that will give patients unprecedented safe, secure access to their health data. The rules are issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) to implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act). These final rules mark the most extensive healthcare data sharing policies the federal government has implemented, requiring both public and private entities to share health information between patients and other parties while keeping that information private and secure. These final rules became effective as of June 30, 2020. NOTE: Due to the COVID-19 public health emergency, HHS has delayed enforcement until future dates. Continue Reading How HHS Information Blocking Regulations Apply to Healthcare Providers
Regulatory developments—such as the Stark Law blanket waivers and the OIG’s enforcement deferral for use of the waivers—have helped healthcare providers during the COVID-19 crisis, but healthcare fraud remains a prime target of the DOJ and the OIG (in addition to state regulators). Between October 2018 and September 2019, the DOJ obtained over $3 billion in judgments and settlements from fraud claims, a substantial portion of those claims relating to healthcare fraud. The significant increase in qui tam litigation since the 1980s is also notable. So what fraud and abuse actions could regulators pursue in COVID-19’s shadow? Continue Reading Do Covid-19 Regulatory Changes Pose an Increased Risk of Fraud and Abuse Liability for Healthcare Providers?
Among the multitude of relief options under the CARES Act, the U.S. Department of Health & Human Services (HHS) allocated provider relief funds (PRF) to healthcare providers. Phase I in late April saw healthcare providers receive $50 billion in general PRF distributions, largely based on historical Medicare volume or net revenues. Phase II followed in early May with general PRF distributions of $15 billion for Medicaid, Children’s Health Insurance Program (CHIP), and dental providers. And continuing after that, HHS issued some $52 billion in targeted PRF distributions among: (1) hospitals treating large numbers of COVID-19 patients; (2) rural providers; (3) skilled nursing facilities; (4) safety net hospitals; and (5) tribal healthcare providers. All in all, HHS issued $175 billion in PRF to support healthcare providers.
On August 4, 2020, the Office of Inspector General of Health & Human Services (OIG) used a new website resource to share informal guidance on the ability of laboratories to provide free COVID-19 antibody testing to Medicare beneficiaries. For the specific situation, the requestors indicated that the clinical lab would provide free COVID-19 antibody testing to patients—including federal healthcare program beneficiaries—in conjunction with other medically necessary blood tests performed by the lab. The lab indicated that it would not charge any patient or other payors for the COVID-19 antibody tests offered in conjunction with other paid lab tests. The requestors also indicated that the purpose of the arrangement had a public health focus as it was intended to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which can be used for certain experimental convalescent plasma therapy treatments for COVID-19.
On June 30, 2020, Winstead PC attorney Sarah Churchill Llamas participated in a panel discussion—How to Increase Enterprise UX?—as part of the UX & Telehealth RapidConf. Discussions centered on telehealth and its overall market-effect in the rapidly evolving healthcare landscape. The panel was hosted by Fabien Beckers (Arterys), and included other panelists such as Laura Berrara (ECG Management), John Fryer (Lumeris), and Balint Bene (bene : studio). Here are a few key takeaways from the discussion: