2008: The Ryan Haight Act
The federal government has long been concerned about the prescription of controlled substances via the internet. Under the Controlled Substances Act (CSA), all controlled substance prescriptions must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) amended the CSA to generally require at least one in-person medical evaluation for purposes of prescribing controlled medications by way of the internet. The Ryan Haight Act was designed to combat the proliferation of “rogue” internet pharmacies in the 1990s selling controlled substances online with little oversight, sometimes on the basis of an online questionnaire. It was passed, however, during a time in which telemedicine was not a widespread practice.
The Ryan Haight Act required a telemedicine provider to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance to that patient, unless an exception applied. Under the Ryan Haight Act, no controlled substance was allowed to be delivered, distributed, or dispensed by means of the internet, including telemedicine, without a “valid prescription.” A valid prescription generally means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient. An “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.
2015: Industry Pressure to Define the "Special Registration" Exception
The Ryan Haight Act included an exception to the in-person medical evaluation requirement for a practitioner engaged in the so-called “practice of telemedicine.” The enumerated circumstances in which the “practice of telemedicine” exception applied were narrow, including but not limited to the declaration of a Public Health Emergency (PHE) by the Secretary of HHS or where the patient was being treated by a practitioner who holds a “special registration.” Notably, the Drug Enforcement Agency (DEA) has never defined “special registration” nor created processes regarding special registrations.
On October 6, 2015, the American Telemedicine Association sent a letter to the DEA advocating for changes to the federal controlled substance prescribing rules that were more provider-friendly. The letter outlined suggestions for structuring a special registration process to safely enable the prescribing of controlled substances via telepsychiatry.
2016: Legislative Directive to Define the "Special Registration" Exception
Subsequently, on October 24, 2018, the President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which amended CSA Section 311(h)(2) to require that not later than one year after enactment, the Attorney General, in consultation with the HHS Secretary, promulgate final regulations specifying the limited circumstances in which a special registration for telemedicine may be issued and the procedure for obtaining the registration. In accordance with the Congressional directive, HHS and the DEA held regular meetings with industry experts on the topic with the plan of issuing a new telemedicine prescribing rule. However, the DEA missed the applicable statutory deadline to adopt regulations to modernize the rules, and to this day, has still failed to adopt regulations as directed by the SUPPORT Act.
2020: Public Health Emergency (PHE) Flexibilities
In response to the COVID-19 Public Health Emergency (PHE), as declared by the Secretary of the Department of HHS on January 31, 2020, the DEA granted temporary exceptions to the Ryan Haight Act. On March 16, 2020, the DEA waived the Ryan Haight Act requirement that a practitioner prescribing a controlled substance over the internet must have conducted at least one “in-person medical evaluation” of the patient provided that certain requirements were satisfied, including that “[t]he telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.” The DEA further relaxed this policy to allow an audio-only connection to prescribe controlled substances on March 31, 2020.
March 2023: New Proposed Rules: Telemedicine Controlled Substances and Telemedicine Buprenorphine
In an attempt to create new pathways under the practice of medicine “catchall” exception to the Ryan Haight Act’s in-person medical examination requirement, the DEA published two proposed rules on March 1, 2023: (1) the telemedicine controlled substances proposed rule; and (2) the telemedicine buprenorphine proposed rule. The proposed rules included three new exceptions for telemedicine providers prescribing controlled substances without a prior in-person medical exam, but the rules were overall much more limiting than the DEA’s PHE waiver and still did not address “special registration” for telemedicine prescribing. The rules allowed prescribers to issue prescriptions pursuant to a telemedicine encounter for all schedule II–V controlled substances if: (1) the prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice; (2) the telemedicine communication was conducted using an audio-visual, real-time-two-way interactive communication system; and (3) the practitioner is acting in accordance with applicable federal and state laws.
The rules were not well received by healthcare industry stakeholders hoping for a less restrictive outcome. The rules re-established many pre-pandemic barriers to care and did nothing to help the gaps in continuity of care for patients who had become accustomed to receiving prescribed substances via virtual visits. Of particular concern were patients with opioid use disorder, pain, ADHD, sleep disorders, panic and anxiety, epilepsy, and others. Accordingly, the DEA received more than 38,000 comments in response to the proposed rules, a record-breaking number of public comments. Many stakeholders expressed concerns that the proposed rules were more restrictive than necessary.
May 2023: First Temporary Rule: Extension of COVID-19 Telemedicine Flexibilities #1
On May 10, 2023, in reaction to the negative industry response, the DEA exercised their authority to extend previous flexibilities in a temporary rule entitled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” temporarily extending the DEA’s COVID-19 waivers regarding prescribing controlled substances via telemedicine that were in place since March of 2020 (First Temporary Rule). This extension was set to expire on November 11, 2023. Under this flexibility, the same flexibilities under the PHE waiver that governed controlled substance prescribing would continue to apply through November 11, 2024, if a patient and practitioner established a telemedicine relationship on or before November 11, 2023.
According to the DEA, the “goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules.” The DEA also highlighted plans to issue “one or more final rules” that are “based on the two proposed rules published on March 1, 2023.” In terms of substance, the DEA predicted the final rule(s) would “extend certain telemedicine flexibilities on a permanent basis.”
September 2023: Renewed Directive from Congress to Defined the "Special Registration" Exception
On September 13, 2023, 15 years after the Ryan Haight Act was passed, Congress has now reiterated its directive to develop the special registration process by delivering a letter addressed to the DEA Administrator stating: “[Congress] created a ‘special registration’ exception, not as an option for DEA to utilize but a requirement to do so.”
October 2023: Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
As the First Temporary Rule was expected to expire, the DEA held two public Telemedicine Listening Sessions in September 2023 to collect input regarding prescribing controlled substances via telemedicine. Following a deluge of feedback received both in the Telemedicine Listening Sessions and in response to the March 2023 proposed rules, there was a clear need to further evaluate the nuts and bolts of a permanent rule. Thus, the DEA and HHS issued a Second Temporary Rule extending the full set of telemedicine flexibilities regarding the prescription of controlled medications that were in place during the COVID–19 PHE.
Building on the First Temporary Rule, the DEA and HHS published the Second Temporary rule on October 10, 2023, extending the telemedicine flexibilities for prescribing controlled medications through December 31, 2024. Much like the First Temporary Rule, the extension allows for the prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. The grace period provided by the First Temporary Rule was effectively subsumed by the Second Temporary Rule, which continued the extension of the current telemedicine prescribing flexibilities issued in the PHE for all practitioner-patient relationships, not only those established on or before November 11, 2023, until December 31, 2024.
In deciding to issue this Second Temporary Rule, the DEA weighed different interests, including the benefits of easier access to care versus the risks of incentivizing companies to engage in problematic prescribing practices. The purpose of this Second Temporary Rule, similar to the first extension, is to ensure smooth a transition for patients and practitioners who have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allow adequate time for providers to come into compliance with any new standards or safeguards. Further, the DEA and HHS have determined that this second temporary rule is consistent with “effective controls against diversion and otherwise consistent with the public health and safety” as required under 21 U.S.C. 802(54)(G).
Other stated purposes include:
- Prevent a reduction in access to care for patients who do not yet have an existing telemedicine relationship with their practitioners pending promulgation of a final rule or rules addressing telemedicine more generally;
- For relationships established both during the COVID–19 PHE and those established shortly after, prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities and ensure the availability of telemedicine for practitioners and patients who have come to rely on it;
- Address the urgent public health need for continued access to the initiation of buprenorphine as medication for opioid use disorder in the context of the continuing opioid public health crisis;
- Allow patients, practitioners, pharmacists, service providers, and other stakeholders sufficient time to prepare for the implementation of any future regulations that apply to prescribing of controlled medications via telemedicine;
- Enable DEA and potentially HHS to thoroughly consider the presentations made at the Telemedicine Listening Sessions;
- Enable DEA, jointly with HHS, to conduct a thorough evaluation of regulatory alternatives in order to promulgate regulations that most effectively expand access to telemedicine encounters in a manner that is consistent with public health and safety, while also effectively mitigating against the risk of possible diversion; and
- Avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the second extension of flexibilities to a short, time-limited period.
Impact on Providers
Although this latest extension of COVID–19 flexibilities is temporary in nature, the Second Temporary Rule is nonetheless a win for patients and clinicians utilizing telemedicine across a variety of specialties. Providers currently prescribing controlled substances in accordance with federal and state law using telemedicine may continue to do so for at least another year. This extension is particularly important for providers engaging in telepsychiatry, as there continues to be a national shortage of qualified behavioral health professionals as the need for behavioral health services rises.
The DEA and HHS have emphasized their intention to promulgate a final telemedicine rule regarding prescribing controlled substances. The DEA continues to carefully consider the input received in the Telemedicine Listening Sessions and the public comments responding to the proposed rules. The DEA announced that it is working to promulgate a final set of telemedicine regulations by the fall of 2024 to give patients and medical practitioners time to plan for and adapt to new rules once issued.
The DEA and HHS are currently developing regulations with the stated goals of providing access to telemedicine as consistent with public health and safety while effectively mitigating the risk of possible diversion. That being said, it is still unclear whether the DEA will create a “special registration” process after failing to do so in the past. The special registration topic was raised during a DEA Telemedicine Listening Session after the DEA’s Listening Session Notice stated that the DEA is open to considering, for some controlled substances, a special registry without in-person requirements. To the extent that Congress has the authority to pass further legislation regarding telemedicine prescribing, it has not yet indicated its intent to do so. Currently, there are no bills before Congress that would change the state of the law regarding controlled substance prescribing via telemedicine. Short of taking legislative action, Congress could conceivably pressure the DEA and HHS by way of non-judicial remedies, such as threatening to withhold appropriations in particular areas in subsequent years. Congress could also theoretically ask the court to issue a declaratory judgment compelling the DEA and HHS to act. However, the authors of this article are unaware that any such efforts are being taken by Congress.
In the meantime, practitioners can continue to prescribe certain controlled medications via telemedicine without a prior in-person examination through December 31, 2024, in accordance with federal and state laws. The final rules on telemedicine prescribing of controlled substances are expected to be issued at the same time that critical changes to Medicare’s reimbursement of telehealth services are expected to take place, as the Centers for Medicare and Medicaid Services has also extended many other telehealth flexibilities from the PHE until the end of the year 2024. Thus, 2024 is slated to be a pivotal year for PHE-driven telehealth and telemedicine.