Prescribing Via Telehealth: The Evolving Regulatory Landscape
Telehealth prescribing offers physicians, psychiatrists emerging options for reaching patients with psychiatric, substance abuse, pain treatment.
As new technologies develop rapidly to facilitate electronic linkages between patients and healthcare providers, the telehealth industry continues to strain and outgrow its regulatory framework. This is particularly evident in the area of telehealth prescribing, where regulatory inaction by the U.S. Drug Enforcement Administration (DEA) has for years hindered physicians and other providers in reaching those in need of psychiatric, substance abuse, and other services involving the prescription of controlled substances.
With Congress’s passage of the Special Registration for Telemedicine Act (SRTA) in late 2018, the telehealth industry will finally get some much-welcomed development on the issue of telehealth prescribing. Once implemented, SRTA will create a pathway for practitioners to prescribe, using telehealth platforms, a controlled substance to a patient whom the prescribing practitioner has not medically examined in person. Critically, by removing the existing in-person medical exam requirement for telehealth prescribing, SRTA will allow providers to more easily prescribe a wide range of controlled substances that can be prescribed safely and effectively by means of a telehealth encounter.
But first, the telehealth industry will have to wait a little while longer. That’s because SRTA isn’t self-executing. Instead, it mandates that the DEA must, no later than a year from its passage (on October 24, 2018), issue regulations regarding a “special registration” process for practitioners seeking exemption from the in-person medical exam requirement. For years, the DEA has possessed the legal authority to promulgate these special registration regulations but has failed to exercise it. SRTA effectively forces the DEA to act with the imposition of the one-year timeline for publishing the regulations.
The Ryan Haight Online Pharmacy Consumer Protection Act
The path leading to enactment of SRTA begins with the federal Ryan Haight Online Pharmacy Consumer Protection Act (or simply the Ryan Haight Act). In 2008, Congress passed the legislation to regulate the proliferation of online pharmacies. The death of Ryan Haight, a young man who overdosed on prescription painkillers that he purchased from an online pharmacy without a valid prescription, served as an impetus to act.
The Ryan Haight Act effectively prohibits form-only online prescribing for controlled substances by requiring that a healthcare practitioner conduct an in-person medical exam before a prescription for a controlled substance may be delivered, distributed, or dispensed through the Internet. The law does provide for certain exceptions to the in-person medical exam requirement where a practitioner is engaged in the “practice of telemedicine.” But, as the telehealth industry has learned over the past 10 years, these “practice of telemedicine” exceptions are limited in scope and inapplicable to developing trends in areas such as telepsychiatry that emphasize greater engagement with patients wherever they may be, whether at school, home, or work.
Notably, the Ryan Haight Act provided for greater flexibility in telehealth prescribing by giving the DEA the authority to create a “special registration” process through which telehealth practitioners could prescribe controlled substances without an in-person medical exam. However, in the ensuing years the DEA has never released any regulations to effectuate the special registration. As a result, telehealth practitioners have been limited in their ability to prescribe controlled substances in those instances where technological advances have rendered an in-person medical exam unnecessary.
Now that SRTA is law, the clock is ticking for the DEA to put into effect the special registration regulations. To this end, the DEA will commence a notice-and-comment rulemaking through which the public will have an opportunity to review and comment on the DEA’s proposed regulations. Interested stakeholders should monitor the release of these proposed regulations and consider voicing their opinion to shape the final rules.
State Law Developments in Telehealth Prescribing
The lack of regulatory action by the DEA has not deterred lawmakers from pursuing telehealth prescribing reforms at the state level. While the nuances of state telehealth laws differ significantly from state to state, a number of states in recent years, such as Indiana and Michigan, have revised their controlled substance laws to allow remote prescribing via telehealth. Many of these reforms are being driven by the opioid epidemic and an increased awareness among legislators that telehealth prescribing can expand access to medications to treat opioid addiction. To be sure, legislators in many states also understand that, without proper safeguards, telehealth prescribing could lead to greater opioid prescribing and therefore in some legislative reforms have included exceptions that prohibit telehealth prescribing of opioids.
Call Jackson LLP’s Experienced Telehealth Attorneys Today
At Jackson LLP, we are experienced in navigating the evolving regulatory landscape of federal and state laws governing the telehealth industry. Whether you are a prescriber or a tech start-up looking to make an entry in the telehealth space, we can guide you on the latest telehealth law developments to ensure you remain legally compliant. Like other industry stakeholders, we also will be eagerly awaiting the DEA’s proposed special registration regulations and are available to assist you in submitting comments regarding the impact they may have on your practice or business. To schedule a complimentary phone consultation with one of Jackson LLP’s healthcare attorneys, click the button below.