In a report issued by the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) on March 23, 2021 (the “2021 Report”), representatives from 320 hospitals in 45 states, the District of Columbia, and Puerto Rico were interviewed on their experiences responding to the COVID-19 pandemic. Questions were focused on the hospitals’ most difficult challenges in responding to COVID-19, strategies used by the hospitals in addressing or mitigating those challenges, and how the government could best support hospitals responding to COVID-19. This report was a follow-up to a similar OIG pulse survey released about a year ago on April 3, 2020 (the “2020 Report”), which summarized hospitals’ answers to the same questions near the start of the pandemic. The two reports, published one year apart, provide a useful snapshot into how hospital challenges have evolved in responding to the pandemic. Looking at the two reports side-by-side, we compare the challenges hospitals faced in 2020 versus the challenges they are now contending with one year later in 2021.
Continue Reading One Year Later: OIG Reports Describe Evolving Challenges Hospitals Have Faced in Pandemic Health Care Delivery

As is the case with most new technologies or significant industry innovations, companies embracing and driving the disruptions often move very fast in a legal and political landscape that is always playing catch-up. This is very true for the fast-growing telemedicine and digital health industries. However, likely motivated by COVID-19, state governments are moving faster than they traditionally do to pass new regulations and to extend certain regulatory waivers.

COVID-19 required a shift in the delivery of medical care with the state and local lockdowns. During the pandemic, the United States Department of Health and Human Services (HHS) has issued guidance on various compliance waivers and enhanced flexibility. Governors across the country issued executive orders to help address the requirements of providing ongoing medical care while maintaining proper social distancing (e.g., New Mexico, Texas, etc.). The result was more people receiving medical care remotely. Similar to the realization by many that working from home was not only feasible but in some cases preferable, many also came to the conclusion that a trip to the doctors’ office was not necessary for the treatment of certain conditions.
Continue Reading Propelled by COVID-19, State Governments Attempt to Keep Up With Telemedicine Innovation and Digital Health Platforms

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the False Claims Act (31 U.S.C. § 3729) by a blood testing laboratory and its contracted sales agents.  The Court held that commission payments made by the laboratory to its sales agents (sales companies that, in turn, hired and contracted salespeople to sell the laboratory blood tests), which were based on the percentage of revenue the sales agents generated for the laboratory through marketing services, constituted improper “remuneration” that intended to induce the sales agents to sell as many laboratory tests as possible. The defendants failed to show that the arrangements fit within an AKS Safe Harbor.
Continue Reading Developments Regarding Commission-Based Compensation Arrangements with Independent Contractors