On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth that have been relied upon by prescribers and patients during the COVID-19 pandemic. The proposed rules respectively address (1) telemedicine prescribing of certain controlled substances without an in-person medical examination (Tele-Prescribing Rule), and (2) expansion of buprenorphine prescribing via telemedicine encounters (Buprenorphine Rule). Below please find a high-level summary of the Tele-Prescribing Rule. A separate post will follow addressing the Buprenorphine Rule in detail.
- This proposed rule applies narrowly to the prescription of controlled medications through telemedicine by a practitioner who has not conducted an in-person medical evaluation of the patient.
- As background, the federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and current DEA regulations require a practitioner to have an in-person medical evaluation with a patient before prescribing controlled medications that are medically necessary via telemedicine, except in seven specific circumstances where permitted by regulation and applicable state law.
- It does not apply to telehealth encounters that do not involve the prescribing of controlled medications, or encounters between a patient and a practitioner that has previously evaluated that patient in person.
- The Tele-Prescribing Rule would allow for the prescription of a non-narcotic schedule III-V controlled medication in certain circumstances following a telemedicine encounter not preceded by an in-person medical evaluation. The Tele-Prescribing Rule requires the following related to such tele-prescriptions:
- The prescription must be for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
- The practitioner must be physically located in the United States at the time of the telemedicine encounter;
- The practitioner must be authorized to prescribe controlled substances under state law in the state where the patient is located during the telemedicine encounter, and the state where the practitioner is located (if different);
- The practitioner must indicate on the prescription that it is the result of a telemedicine encounter;
- Prescriptions must be limited in total to a 30-day supply for the patient, and only be issued over a 30-day period, after which an in-person evaluation would be needed for the practitioner to continue prescribing to the patient (unless the patient has been referred by a practitioner who conducted an in-person medical evaluation);
- Once this 30-day window passes, the practitioner must either evaluate the patient in-person, or the patient must have an in-person evaluation by another DEA practitioner with the prescribing telemedicine practitioner participating remotely. Alternatively, the practitioner may prescribe controlled substances via telemedicine after receiving a qualifying written telemedicine referral from another DEA-registered practitioner (following an in-person encounter between the patient and the referring practitioner).
- The practitioner must review the applicable state prescription drug monitoring program database (PDMP).
- If the practitioner is unable to review the applicable PDMP, the practitioner must limit the prescription to a 7-day supply.
- The Tele-Prescribing Rule includes heightened recordkeeping requirements for practitioners who rely on it to tele-prescribe.
- Practitioners are required to maintain a log of each prescription issued pursuant to a telemedicine encounter, with details regarding the prescription, encounter and referring physician (if any);
- Practitioners involved in evaluations with patients alongside an in-person practitioner via telemedicine must maintain detailed records of such evaluations;
- Such records must be maintained by practitioners at their DEA-registered location.
- The Tele-Prescribing Rule also makes a number of definitional changes to DEA regulations, including to better align them with CMS regulations concerning telehealth and telemedicine practices.
In the Tele-Prescribing Rule, DEA explained its proposal to exclude Schedule II controlled substances and all narcotics from the scope of the rule. DEA stated its belief that “allowing for the prescription of schedule II substances or the general prescription of narcotic controlled substances as a result of telemedicine encounters would pose too great a risk to the public health and safety” given the “ongoing opioid epidemic.”
Finally, the DEA proposes an “off-ramp” for telemedicine prescribing provider-patient relationships which started during the COVID-19 pandemic where the prescribing practitioner has not performed an in-person medical evaluation of the patient. DEA proposes to allow controlled substance prescribing to continue under such relationships for up to 180 days following the end of the federal COVID-19 public health emergency.
Timing of Proposed Rulemaking and Opportunity to Comment
The proposed rules are being proposed now in advance of the scheduled end of the federal COVID-19 public health emergency on May 11, 2023. The ending of the declared COVID-19 public health emergency will simultaneously end many current waivers and programs enacted under federal law to give facilities, providers, insurers, and patients flexibility to enable access to coverage and care in response to the pandemic. The proposed rules are part of the Government’s efforts to ease the transition away from the pandemic-era waivers and program rules, including by making permanent beneficial flexibilities related to delivery of care via telehealth.
DEA has requested comments on the proposed rules, and will be accepting comments for a period of 30 days.