In the wake of COVID-19, the United States continues to struggle with a prior public health emergency: a crisis of opioid and substance addiction. More than 83,000 drug overdose deaths occurred in the United States in the 12 months ending in June 2020, the highest number of overdose deaths ever recorded in a 12-month period, and an increase of over 21% compared to the previous year. Access to treatment programs was already insufficient prior to the pandemic, and social restrictions coupled with feelings of increased stress and isolation have led to even higher rates of overdoses and tragedy. The increase in overdose deaths highlights the need for treatment services to be more accessible for people most at risk of overdose. The pressure to obtain meaningful substance use disorder treatment programs has never been greater, and 2021 can expect to see more efforts by the public and private sectors to address the needs of people experiencing substance use disorder and addiction.
[Editor’s note: On January 14, 2021, HHS announced the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder discussed below. Those guidelines were issued during the Trump Administration. Our legal update was published on January 21, 2021. On January 26, 2021, HHS withdrew the Guidelines. As of this update, the Guidelines and X-waiver are not in effect.]
On the public policy front, the US Department of Health and Human Services just announced it will eliminate the X-waiver requirement for DEA-registered physicians. This move is designed to expand access to medication-assisted treatment (MAT) by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD). The new federal waiver document, titled Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, provides:
There is also federal legislation proposed for consideration that, if enacted, would expand the use of telehealth for MAT and SUD treatment programs. The Comprehensive Addiction and Recovery 2.0 Act (CARA 2.0 Act), introduced in December 2020, would increase funding and allow doctors to prescribe medications for MAT without an in-person exam. It would, in effect, address the barriers for telemedicine-based prescribing of controlled substances under the Ryan Haight Act. Eliminating the Ryan Haight Act’s in-person exam requirement, either through the creation of a special registration or simply amending the statute itself, has been an effort years in the making. The Telehealth Response for E-prescribing Addiction Therapy Services Act (TREATS Act), introduced in June 2020, seeks to achieve similar changes to the Ryan Haight Act alongside expanding Medicare coverage for certain telehealth services.
On the private sector front, there is ample evidence to support telehealth-based interventions and a growing number of studies that support the benefit of telehealth in SUD treatment, showing that virtual care interventions were associated with high patient satisfaction and are an effective alternative, especially when access to treatment is otherwise limited. However, telehealth-based services can be difficult to implement effectively, especially in the SUD population.
To that end, a new guidebook has been published to help inform health plans and enterprising SUD treatment providers on the key issues – regulatory, clinical, technology, and equity – to consider when launching and expanding a telehealth-based addiction treatment program. The guide, Telehealth Solutions for Addiction Treatment, can serve as an implementation roadmap offering checklists and tips alongside links to third party resources. (Lawyers on our Telemedicine & Digital Health Industry Team were contributing authors to the handbook.)
For more information on telemedicine, telehealth, virtual care, remote patient monitoring, digital health, and other health innovations, including the team, publications, and representative experience, visit Foley’s Telemedicine & Digital Health Industry Team Page.