The COVID-19 Public Well being Emergency (“PHE”) led to a fast enlargement within the utilization of telehealth. Now, nearly three years later, governmental entities have targeted their consideration on telehealth companies and the potential for fraud and abuse. In July 2022, the Division of Well being and Human Providers Workplace of Inspector Common (“OIG”) problem a Particular Fraud Alert alerting practitioners to train warning when coming into into preparations with telemedicine corporations. The issuance of this report is a big step and reinforces the federal government’s curiosity in scrutinizing telehealth preparations. The Division of Justice (“DOJ”) and the Drug Enforcement Company (“DEA”) have additionally launched a number of high-profile investigations that the business is monitoring carefully. Telehealth suppliers ought to fastidiously evaluation and replace their practices given the heightened enforcement local weather.
Notable Updates
Anticipated Termination of the PHE
On October 13, 2022, Well being and Human Providers (“HHS”) Secretary Xavier Becerra renewed the COVID-19 PHE and the PHE is now set to run out on January 11, 2023. Though it’s probably the PHE will probably be prolonged once more, suppliers ought to give attention to compliance as it would ultimately attain an finish. The Facilities for Medicare & Medicaid Providers (“CMS”) briefly accepted sure telehealth flexibilities in the course of the PHE. Some flexibilities will stay in impact 151 days after the PHE expires whereas others could stay in place till the tip of the yr through which the PHE ends. Telehealth suppliers ought to fastidiously monitor the standing of the PHE and any bulletins from HHS.
Ryan Haight Act
The Ryan Haight Act of 2008 typically requires a prescribing practitioner to have performed at the very least one in-person medical analysis of a affected person previous to prescribing managed substances through telehealth. Throughout the PHE, the DEA waived the in-person analysis requirement, offered sure circumstances are met. This flexibility is about to run out on the finish of the PHE, and the DEA has not but launched any plans to make sure continuity of care from the PHE waivers. In response, there have been notable calls to motion from legislators, together with Sen. Mark Warner, and business teams. On June 22, 2022 the White Home Workplace of Nationwide Drug Management Coverage launched its steering titled “Telehealth and Substance Use Dysfunction Providers within the Period of COVID-19: Overview and Suggestions.” The steering recommends DEA take into account making everlasting the adjustments carried out in the course of the PHE, together with by authorizing certified practitioners to prescribe managed substances to sufferers utilizing telehealth with out first conducting in-person evaluations.
Along with the lack of knowledge from the federal authorities relating to the permanency of the waivers, it is usually unclear how states will strategy the Ryan Haight Act after the PHE. The New York Workplace of Psychological Well being had launched an Informational Bulletin on Might 10, 2022 titled “Prescription of Managed Substances after the Federal Public Well being Emergency for COVID-19” which has since been faraway from the web site and withdrawn. The steering had reaffirmed that suppliers will probably be required to adjust to the Ryan Haight Act when the PHE ends, and particularly advisable that practitioners start scheduling in-person appointments earlier than the tip of the PHE to handle workload and mitigate danger to sufferers. With the removing of this steering, although, it’s unsure how New York will implement the Ryan Haight Act.
Elevated DOJ Exercise
Though the PHE and its telehealth flexibilities presently stay in impact, the DOJ has began to analyze allegations of fraud and violations of the Managed Substances Act. For instance, the DOJ is investigating telehealth start-ups for potential violations of the Managed Substances Act, together with their prescription and distribution of doubtless addictive medication akin to Adderall and Xanax. The over-prescribing of sure managed substances that are presently in scarcity, akin to Adderall, could also be topic to heightened scrutiny. The DOJ additionally introduced felony fees earlier this yr towards 36 defendants for $1.2B in healthcare fraud for fraudulent telemedicine schemes. As highlighted by the Particular Fraud Alert, telehealth companies are an space of OIG focus.
Wanting Ahead
The DOJ has utilized info discovered on public-facing sources associated to prescribing habits to launch its investigations. Telehealth suppliers ought to fastidiously evaluation and monitor their public info. Moreover, suppliers ought to proceed with warning when prescribing remedies for behavioral and psychological well being, given the DOJ’s heightened scrutiny on this space. The PHE just isn’t a defend towards legal responsibility, and enforcement continues whereas the PHE stays in impact. When the PHE attracts to an finish, and state and federal waivers are terminated, navigation of each state and federal legislation will probably be required. Sheppard Mullin will proceed to watch developments and supply updates as they come up. Suppliers with questions or in search of counsel can contact any member of our Healthcare workforce for help.
