By Clint Watts
Over the past few years, the healthcare regulatory complex has been working to support innovation and electronic integration while addressing public concerns like the opioid epidemic. During this same period, Telemedicine has emerged with the potential to fundamentally change the way patients and providers interact. Though they may disagree as to the answer, regulators, enforcement agents, and telemedicine providers are now united in asking how to best prescribe and manage controlled substances remotely.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Act”) was one of the first attempts to adapt substance control to the digital age. Congress passed the Act to amend the Controlled Substances Act and the Controlled Substances Import and Export Act and “prevent the illegal distribution and dispensing of controlled substances by means of the internet.” It did so by setting forth a number of requirements that restricted the operation of internet pharmacies and remote treatment programs. Among these, a prescribing provider was required to conduct in-person medical evaluations or otherwise meet one of very few narrow exceptions. Under the Act, “[t]he term in-person medical evaluation means a medical evaluation that is conducted with the patient in the physical presence of the practitioner….”
To be fair, practitioners “engaged in the practice of telemedicine” were exempt from the in-person medical evaluation prerequisite, but this practice was narrowly defined. For example, in the broadest exempted category the Act requires a patient to be physically located at a hospital at the moment of remote interaction. Other exempted practices include telemedicine delivered during public or medical emergency situations or byway of tribal health. In most cases, the restrictions of the Act obviated many of the conventional benefits of telemedicine such as the ability to deliver preventative care or maintenance to rural or immobile patients at other appropriate origination sites.
Of course, Congress provided an exception for that too, “special registration”. The DEA was charged with the creation of a registration process that would permit providers to apply to conduct remote medical examinations and prescribe medication in “limited circumstances.” Congress did not, however, provide the DEA with an explicit timeline. The regulations permitting registration were never promulgated, and ten years later telemedicine continues to be limited by the law’s incompleteness.
The industry took up new hope on October 24, 2018, when the President signed the gargantuan “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act” (the “SUPPORT ACT”). Among its many elements, the SUPPORT ACT contained the text of a bill called the “Special Registration for Telemedicine Act of 2018”. In it, Congress returned to “special registration” to provide the DEA with the following mandate:
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:
“(2) REGULATIONS.—Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall 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.”
The wheels have been turning since that time. The Congressional Research Service updated its summary of Special Registration law on December 7, 2018, and, on January 9, 2019, the American Telemedicine Association (ATA) issued the following recommendations in an open letter to the DEA:
- Update the current DEA registration process to specify distinctions between traditional and telemedicine prescribing privileges.
- Allow both sites and prescribers to register for telemedicine.
- Allow for a public comment period within the one-year timeline for special registration activation.
- Ensure that telemedicine special registration is not restricted to any single discipline.
- Allow telemedicine prescribers to apply for DEA registration numbers in multiple states at once.
These recommendations are fleshed out on the Association’s website in greater detail. In many ways, the ATA’s suggestions reflect prevailing industry sentiment, but they are in no way binding upon the Agency. Therefore, it is difficult to anticipate the breadth or usefulness of the special registration process at this time.
With that said, the Agency now has nine months to comply with the SUPPORT ACT’s Congressional mandate. Providers should be engaging with their technology venders and reviewing state law to ensure that they are prepared to take advantage of the new registration format if they believe that doing so could increase the scope and quality of their services. It is important to emphasize that telemedicine is still very much a
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