Telemedicine is a broad term that encompasses countless medical specialties, including psychiatry, radiology, neurology, dermatology, cardiology, oncology, and others. Generally, telemedicine is defined as the remote treatment of patients by medical providers using various forms of telecommunication technology. Telemental healthcare provides a reasonable alternative to an office visit for patients who cannot readily access care.1 One of the key drivers behind telemental healthcare’s growth in the United States is a national shortage of psychiatrists, particularly in specialty areas like child and adolescent psychiatry and in underserviced and rural areas. Recent studies demonstrate that the average wait time for an adult patient to get a doctor’s appointment exceeds twenty days. For child/adolescent patients, the wait time often surpasses 50 days.2,3 Thus, telemental healthcare services delivered through interactive videoconferencing provides for improved access to care, and has become an increasingly employed treatment option.4
Telemental healthcare does not change the standard of care – it is the same standard used as when the patient is physically present in your office. However, there are additional considerations when practicing telemental healthcare that may differ from when the patient is physically in your office, some of which deal with the limitations on remote prescribing authority. This article specifically addresses the remote prescribing authority of controlled substances via telemedicine and its compliance challenges under federal and state law.
The Ryan Haight Act
The Ryan Haight Online Pharmacy Consumer Protection Act (the “Ryan Haight Act”), which added provisions to the Controlled Substances Act, was fully enacted in April 2009. The Ryan Haight Act was implemented with the overall goal of regulating “rogue internet pharmacies” with respect to the distribution and dispensing of controlled substances. The origin of the Ryan Haight Act stems from the prescription drug-abuse crisis and was named after an eighteen-year-old who fatally overdosed on prescription painkillers purchased from an online pharmacy without a valid prescription. Fundamentally, the Ryan Haight Act requires that a valid prescription be issued for all controlled substances. The requirements of a valid prescription are twofold: (1) the prescription must be issued for a legitimate medical purpose; and (2) issued by a practitioner who has conducted at least one in-person medical evaluation of the patient. Specifically, the requirement of an “in-person evaluation” has been a major hindrance for telemedicine providers. In addition, the Ryan Haight Act provides seven “practice of telemedicine” exceptions that eliminate the in-person evaluation requirement. Six of the exceptions are narrowly-tailored, highly technical, and are not conducive to the direct-to-patient model utilized by many telemedicine providers. The final exception gives telemedicine providers the option to obtain a “special registration” allowing remote prescribing of controlled substances, however, the DEA has yet to create the regulatory framework allowing a provider to obtain the special registration, thus leaving this exception unavailable for telemedicine providers.
Evolution of the Ryan Haight Act and the Growth of Telemedicine
Since its introduction into the medical community, telemedicine has grown exponentially. Healthcare Innovation, a healthcare information technology company, reports that telemedicine is predicted to become a $19.5 billion-dollar industry by 2025.5 Yet, despite the growth of telemedicine, the Ryan Haight Act’s special registration exception remains unattainable. In 2015, the American Telemedicine Association sent a letter to the DEA advocating for the development of the special registration exception of the Ryan Haight Act for the prescribing of controlled substances through telemedicine without the requirement of an in-person evaluation. Following this letter, DEA representatives announced their plan to implement the special registration exception, but then no action was taken for nearly two years. Discussion about implementing the special registration exception was rekindled in 2017. Senators called on the DEA to promulgate the special registration exception to expand telemedicine treatment for those battling opioid addiction. On October 24, 2018, the Special Registration for Telemedicine Clarification Act of 2018 was signed into law as part of the larger Support for Patients and Communities Act. This law requires the DEA to “promulgate final regulations specifying (a) the limited circumstances in which a special registration under this subsection may be issued; and (b) the procedure for obtaining a special registration under this subsection.” This law set a deadline of October 24, 2019 for promulgation of these regulations.
The U.S. Department of Health and Human Services (HHS) recently released a clinical case example illustrating how the in-person evaluation requirement can be complied with under existing DEA regulations.6 Under the HHS clinical case example: 1) an in-person, provider who does not have a DATA 2000 buprenorphine waiver, but does have an active DEA license, sees a patient and determines that the patient is a candidate for Medication Assisted Treatment (MAT); 2) the in-person provider contacts a remote psychiatrist practicing at a distant site, who has both an active DEA license and a buprenorphine waiver; and 3) the remote psychiatrist concurs and prescribes buprenorphine remotely.7 Under the HHS example described above, an in-person evaluation is conducted, but technically it is not done by the prescribing physician.
State Law V. Federal Law – The Role of Preemption
In response to the limitations of the telemedicine exceptions in the Ryan Haight Act, many states passed their own legislation addressing the prescribing of controlled substances by telemedicine providers. Below is a snapshot of telemedicine legislation from a handful of states to illustrate the various stances on this issue. This is not a complete list of states, but the analysis of the specific states below demonstrates the various forms these regulations have taken across the country. You are encouraged to check the rules and regulations in your state, as well as any state where you or your patients plan to participate in telemedicine.
- Connecticut – Originally, Connecticut was among the few states with a ban on the prescribing of controlled substances via telemedicine. In 2018, Connecticut shifted its position on this issue and as of July 1, 2018, providers are permitted to prescribe Scheduled II or III controlled substances via telemedicine for the treatment of “psychiatric disabilities or substance abuse disorders…including, but not limited to, medication assisted therapy.” Nonetheless, providers are still prohibited from prescribing opioids. Connecticut law also states that providers are required to conduct telemedicine encounters through real-time audio and visual communications, while audio-only communications are not permissible.8
- Delaware – Delaware law requires physicians to establish a valid physician-patient relationship “either in-person or through telehealth.” This relationship can be established through audio and visual communications, as audio-only communications are not sufficient. Physicians are also subject to additional requirements, which include obtaining patient consent, ensuring appropriate follow-up care, and verifying the patient’s identity and location. After satisfying these requirements, providers are generally able to remotely prescribe controlled substances, subject to limitations set by the Medical Board. In addition, the same standard of care applies to both remote prescribing and in-person prescribing.9
- Indiana – Indiana recently eliminated its 2016 ban on the remote prescribing of controlled substances. Indiana law now permits providers to prescribe controlled substances via telemedicine subject to certain restrictions and conditions. They still require an in-person evaluation of the patient by an Indiana healthcare provider; this evaluation does not have to be performed by the prescriber. They also require the examining healthcare provider to establish a treatment plan to be utilized by the remote prescriber. Generally, Indiana permits the remote prescribing of controlled substances with the exception of opioids. They specifically prohibit the remote prescribing of opioids unless they are a “partial agonist used to treat or manage opioid dependence.”10
- West Virginia – West Virginia law requires the establishment of a physician-patient relationship. This relationship can be established through audio and visual communications, but audio-only communications alone are not sufficient. Physicians are also subject to the additional requirements of obtaining appropriate patient consent, verifying the patient’s identity and location and obtaining a thorough medical history. With respect to the prescribing limitations, West Virginia law generally prohibits the remote prescribing of Schedule II controlled substances based solely on telemedicine encounters and Schedule II through V pain-relieving controlled substances as “part of a course of treatment for chronic non-malignant pain solely based upon a telemedicine encounter.”11
- South Carolina – South Carolina law also requires the establishment of a physician-patient relationship, however, unlike other states, South Carolina does not require the use of audio and visual communications. Instead, providers must only employ “technology sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care.” Physicians are also subject to the additional requirements of verifying the patient’s identity and location, ensuring appropriate follow-up care, and discussing the importance of having a reliable point of primary care. South Carolina permits the remote prescribing of controlled substances via telemedicine, except for Schedule II and Schedule III drugs, unless such drugs are “specifically authorized by the board.”12
These variations in state laws prompt the question whether federal law will “preempt” state laws that are inconsistent with the Ryan Haight Act. “Preemption” is the power of federal law to supersede inconsistent state laws. Currently, there is no mention of preemption in the Ryan Haight Act, however, that is not true of the Controlled Substances Act. The Controlled Substances Act indicates that if a conflict exists between federal and state law, federal law will preempt state law. However, there is additional language giving some authority to the States to pass their own legislation on this issue. This ambiguity in the law can make federal preemption, and the national consistency that goes with that, more difficult to achieve. While some may think federal preemption and a nationally consistent set of rules makes the most sense, that may not necessarily be the case. For example, strict rules requiring in-person physician relationships may be easy to accomplish in densely populated Manhattan, but substantially less so in the vast expanses and less populated areas of Montana. For this and many other reasons, the federal and state laws on this subject continue to evolve.
Telemedicine has gained acceptance in the medical and patient communities and likewise continues to gain traction in the realm of psychiatry. Its use in medicine is expected to grow. Telemedicine is currently governed by various state and federal laws, including the Ryan Haight Act, all of which are still evolving and will continue to do so. Telemedicine practitioners, especially those who may seek to prescribe controlled substances through telemedicine encounters with patients, should remain vigilant in their familiarity with the various laws governing the practice. These include federal laws, as well as the state laws of the state(s) where the practitioner is located and the state(s) where their patients are located.
1 Hoffman, J., “When Your Therapist Is Only a Click Away” New York Times (September 25, 2011). http://www.nytimes.com/2011/09/25/fashion/therapists-are-seeingpatients-online.html.
2 Steinman, KJ, et al., “How Long Do Adolescents Wait for Psychiatry Appointments?” Community Ment Health J, 2015 Oct: 51(7): 782-9.
3 Psychiatry Advisor, “Long Wait Times Typical for Psychiatry Appointments,” (October 16, 2014).
4 American Psychiatric Association and American Telemedicine Association, “Best Practices in Videoconferencing- Based Telemental Health,” (2018).
5 “Telehealth Market Estimated to Reach $19.5B by 2025,” www.hcinnovationgroup.com, April 2, 2018
6 U.S. Department of Health and Human Services, “Telemedicine and Prescribing Buprenorphine for the Treatment of Opioid Use Disorder,” (September 2018).
8 Conn. Gen. Stat. Section 19a-906 (2018).
9 24 Del. C. § 1769D.
10 Burns Ind. Code Ann. § 25-1-9.5-8.
11 W.Va. Code § 30-3-13a.
12 S.C. Code Ann. § 40-47-37.