A bipartisan pair of US senators have proposed legislation that would allow certain controlled substances to be prescribed via an initial telehealth encounter and—under certain conditions—expand Medicare reimbursement of audio-only substance use disorder treatment services. The proposed TREATS Act has been referred to the Senate Committee on Health, Education, Labor, and Pensions, and could significantly reduce the regulatory burdens associated with the remote prescribing of controlled substances.
For more than a decade, healthcare providers in the United States have been largely prohibited from prescribing controlled substances via telehealth without having previously performed an in-person medical evaluation of the patient. Although Congress created the framework for a “special registration” pathway that has the potential to more broadly permit the practice, the Drug Enforcement Administration (DEA) has not issued regulations to implement it. This has been a significant roadblock for the treatment of substance use disorder, which is often treated with controlled substances. Recently, Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI) proposed the Telehealth Response for E-prescribing Addiction Therapy Services Act (the TREATS Act), which would allow certain controlled substances to be prescribed via telehealth. The TREATS Act also proposes to expand Medicare reimbursement of audio-only substance use disorder treatment services, if certain conditions are met. The TREATS Act was introduced on June 30, 2020, and has been referred to the Committee on Health, Education, Labor, and Pensions.
Remote Prescribing of Schedules III and IV Controlled Substances
The remote prescribing of controlled substances has been stymied by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), which typically requires providers to perform an in-person medical evaluation of the patient prior to prescribing controlled substances. The Ryan Haight Act does incorporate seven pathways by which practitioners can prescribe controlled substances via telemedicine without a prior in-person examination, but these exceptions are extremely narrow and it is difficult for most providers to meet their requirements. One of the pathways, however, called for a “special registration process” that had the potential to more broadly permit providers to prescribe controlled substances via telemedicine. Congress left the implementation of the special registration process up to the DEA—and the DEA never issued regulations to implement it. After ten years of silence, Congress again pushed the DEA to act, imposing a second deadline for the DEA to implement regulations regarding the special registration process by October 24, 2019, under the SUPPORT for Patients and Communities Act. While there were rumblings that the DEA was prepared to act in late 2019, it is still yet to issue a proposed rule regarding the special registration process.
As we explained in a prior On the Subject, the COVID-19 public health emergency ushered in a significant, albeit temporary, change to the Ryan Haight Act, permitting providers to prescribe controlled substances via telehealth without a prior in-person medical evaluation during the pendency of the public health emergency declared by the Secretary of Health and Human Services. As a result, since March 16, 2020, DEA-registered practitioners have been able to prescribe controlled substances without an in-person medical evaluation of the patient, as long as they conduct a telehealth evaluation using audio-visual, real-time, two-way interactive communications.
The TREATS Act would make this flexibility permanent in certain circumstances, permitting providers to prescribe controlled substances in Schedules III and IV on the basis of a telehealth evaluation. While Senators Portman and Whitehouse introduced the bill largely to expand the use of telehealth to treat substance use disorder, it would have broader ramifications because the bill (as proposed) would apply to all Schedule III and IV controlled substances, regardless of the reason for which the substances are prescribed. Under the bill’s current language, the telehealth evaluation would have to be provided via audio and video equipment permitting two-way, real-time communication, and it would otherwise have to comply with applicable state and federal laws. Certain state laws may still limit prescribing of controlled substances, as many states regulate remote prescribing of controlled substances even more strictly than the federal government; in some cases, states prohibit the practice altogether.
Audio-Only Substance Use Disorder Treatment Services
In addition to the relaxation of remote prescribing of Schedules III and IV controlled substances, the TREATS Act also seeks to expand Medicare’s reimbursement of audio-only substance use disorder treatment services. Specifically, the TREATS Act would permit audio-only services to be reimbursed if the treating practitioner had already conducted an in-person evaluation of the patient or a telehealth evaluation that uses both audio and visual services.
The proposal to reimburse audio-only substance use disorder treatment services represents a significant deviation from the current regulatory environment. Although the Centers for Medicare and Medicaid currently permits some Medicare reimbursement of audio-only telehealth services because of the COVID-19 pandemic (and is currently seeking comment in the 2021 Physician Fee Schedule proposed rule On the Subject about whether to continue to pay for audio-only telephone evaluation and management services), it has historically only reimbursed for telehealth visits that take place using audio and video equipment that incorporate a live, two-way interactive communication between the practitioner and the provider because of statutory limitations. Moreover, many states—which often have more liberal telehealth policies than the federal government—explicitly exclude audio-only telephone services from their definition of telehealth or telemedicine. Accordingly, it would be a fairly significant policy shift if Congress began to permit the reimbursement of audio-only services to treat substance use disorder