Editor’s Note: This article is the second part of a series addressing telehealth and substance use disorder treatment, designed to give practical guidance and orientation to health care providers, substance use treatment programs, and entrepreneurs alike. To read part 1 of this series, click here.
Our prior article discussed federal law barriers to entry for the use of telehealth in substance use disorder (SUD), and specifically, opioid use disorder (OUD) treatment, and highlighted notable opportunities to use virtual care technologies in these service models. This article discusses corollary state law rules and requirements for SUD providers.
A medication commonly used in Medication-Assisted Treatment (MAT) for OUD patients is buprenorphine, a Schedule III controlled substance. While there are federal requirements, such as DATA 2000 waivers and DEA registrations, providers also must comply with state-imposed SUD treatment requirements. Most states closely regulate SUD treatment services, particularly OUD-related services, but each state varies on its regulatory approach, including how it defines SUD treatment programs, and whether state licensure or oversight is required. If a SUD treatment program requires state licensure, the use of telehealth can further complicate the analysis, as many state licensure protocols generally have not been written to contemplate the use of a virtual-only model. As such, state SUD licensing rules often contain antiquated or irrelevant survey elements, tied to brick and mortar locations that simply do not apply to a telehealth-only program. Health care companies seeking to offer SUD treatment across multiple states must review and understand each state’s legal and regulatory framework or it may risk potential civil and criminal sanctions for operating an unlicensed/uncertified SUD treatment program. Adding to the complexity is that state licensure and regulation of SUD treatment programs are not always found under the state’s “department of health,” but instead, could be housed in the state opioid treatment authority, a state mental health agency, or a state agency created specifically for the regulation of SUD treatment programs.
Certain states limit the applicability to SUD treatment program licensure and regulatory requirements to specific provider types, such as programs operating out of brick-and-mortar facilities (e.g., residential programs or opioid treatment programs (OTP)/methadone programs, etc.), or programs accepting state/public funding (e.g., Medicaid reimbursement). Further, some states exempt office-based professional practices or individual practitioners providing SUD treatment services within the scope of their licensure. This can mean easier initial launch options for physician-owned medical groups to treat SUD patients. However, the application of any such exemptions must be carefully analyzed, as some exemptions are intended to be limited in scope.
If a SUD treatment program model does require state licensure, the use of telehealth can further complicate the analysis, as state licensure protocols generally have not been written to contemplate the use of a telehealth-only model. This is likely due to the fact that prior to the COVID-19 waivers, a telehealth-only SUD program utilizing controlled substance prescribing would have been difficult, at best, under the federal Ryan Haight Act’s in-person exam requirements. As such, state SUD licensing rules often contain antiquated or irrelevant survey elements tied to brick and mortar locations that simply do not apply to a telehealth-only program.
SUD program providers must also consider and analyze state laws restricting the prescribing of controlled substances generally, and specifically, prescribing controlled substances via telemedicine. While a number of states permit the prescribing of controlled substances using telehealth, other states prohibit or restrict telemedicine prescribing of controlled substances. In addition, some states have additional licensing or registration requirements applicable to controlled substance prescribing generally, even in a traditional setting. For example, Maryland maintains its own controlled substances registration requirement that parallels the DEA-registration requirement. Some states also maintain additional guidelines and requirements on the prescribing of buprenorphine or opioids for SUD treatment, in addition to state law on prescribing controlled substances.
In response to the COVID-19 public health emergency, some states have waived controlled substance prescribing laws, including laws specifically relating to prescribing buprenorphine in an office-based setting for opioid addiction. For example, on March 18, 2020, the State Medical Board of Ohio issued a guidance document on the use of telemedicine during the state of emergency to “better allow licensees to respond and provide essential health care during the COVID-19 pandemic,” which allowed providers to use telemedicine in place of in-person visits when prescribing controlled substances and office-based treatment for opioid addiction.
Other some states have taken action to permanently expand their SUD treatment laws and regulations. For example, on July 21, 2020, New Hampshire signed HB 1623 into law, which, among other changes, lifts restrictions on telemedicine prescribing of controlled substances used in SUD treatment. The recently enacted law allows telemedicine prescribing of controlled substances for SUD treatment without a prior in-person face-to-face interaction if the patient is physically located at certain enumerated locations (i.e., a correctional facility, a “doorway” as defined in the new law, a state designated community mental health center, or a DEA-registered hospital or clinic). The law also removes the face-to-face requirement for Department of Veterans Affairs (VA) practitioners or VA-contracted practitioners. The initial in-person exam is still required unless the patient presents at one of these enumerated locations.
In our discussions with state regulators tasked with overseeing SUD treatment programs in various states, we are pleased to share that many states are actively engaged in conversations on how they can incorporate telehealth into their SUD treatment programs regulatory architecture. Companies interested in offering SUD treatment programs should consider how they can implement telehealth technologies to address the continued, and growing, issue of substance use and opioid use disorders. State agencies are interested and ready to listen.
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.