On July 20, 2022, the Office of Inspector General for the Department of Health and Human Services (“OIG”) issued a special fraud alert (“Alert”) advising “practitioners to exercise caution when entering into arrangements with purported telemedicine companies.” The Alert is only one of four such “special fraud alerts” that the OIG has issued in the past decade and it illustrates the importance of OIG’s statements.

OIG Flags Seven Characteristics of Telehealth Fraud

In the Alert, OIG cautions that certain companies that purport to provide telehealth, telemedicine, or telemarketing services (collectively, “Telemedicine Companies”) have carried out fraudulent schemes by: (i) aggressively recruiting physicians and non-physician practitioners (collectively, “Providers”) and (ii) paying kickbacks to such Providers in exchange for the ordering of unnecessary items or services, including durable medical equipment, genetic testing, and other prescription items. According to OIG, the fraudulent schemes have varied in design and operation and involved a variety of individuals, Providers, and health care vendors, including call centers, staffing companies, and marketers.

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.

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.

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.