The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms, many of which have relied upon COVID-19 regulatory waivers to launch and operate in multiple states across the nation. For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny.
A variety of conditions may be conspiring against businesses in certain segments of the health care industry. These include reduced patient census at skilled nursing and other long-term care facilities, COVID regulations that limit the ability of providers to give (or patients to receive) various forms of treatment and patients…
Although the COVID-19 pandemic is still active worldwide, health care industry leaders and regulators have already begun to think about how to implement post-pandemic changes to health care delivery based on lessons learned during the global emergency of the past year and a half. We have reported on some such post-pandemic changes to the health care industry in previous blog posts. For instance, some temporary solutions to challenges presented by COVID-19 are being made permanent due to their proven efficiency or effectiveness. The expansion of telehealth is a primary example of this. We have seen the Centers for Medicare and Medicaid Services (“CMS”), as well as state governors and legislators, expand and extend certain regulatory waivers that were initially designed as temporary solutions to allow for greater access to patient care during the pandemic, but that are becoming permanent fixtures due to their usefulness in innovative patient care delivery generally.
Other post-pandemic changes to the health care delivery landscape will be borne out of sheer necessity rather than innovation.
Many forces have been driving the growth of telehealth over the past decade, including value-based reimbursement models, population health management trends, and technology advancements. As we have discussed in previous blog posts, the COVID-19 pandemic was the jet fuel that propelled telemedicine utilization into the stratosphere. This growth was, in large part, due to the necessity of limiting in-person contact to avoid widespread COVID-19 transmission. In fact, as COVID-19 began to spread across the United States, the Centers for Disease Control and Prevention (“CDC”) advised health care providers to offer care via telemedicine technologies wherever appropriate. However, not all of this growth in the telehealth space can be attributed to the necessity of social distancing during the pandemic; even as transmission of COVID-19 has slowed in many areas, providers continue to offer telehealth for patient care, and patients continue to utilize it.
On June 24, 2021, New York Governor Andrew Cuomo issued Executive Order 210, which officially declared the end of the New York State of Emergency caused by the COVID-19 pandemic effective June 25, 2021. The issuance of the Executive Order marked an important milestone for life post-pandemic and a welcome result for small businesses barely treading water trying to comply with the COVID-19 restrictions. However, the abruptness of the announcement, the limited carve-outs for health care professionals and the organizations that employ or contract with them, and the lack of permanent alternative solutions will create a tumultuous few weeks for those parties.
On June 10, 2021, the U.S. Department of Labor Occupational Safety and Health Administration (“OSHA”) announced “an emergency temporary standard to protect healthcare workers from contracting coronavirus.” The standard focuses on healthcare workers that are on the front lines of the fight against COVID-19, aiming to increase protections for those who “continue to be at high risk of contracting the [disease] . . . while they provide us with critical healthcare services.”
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.
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.