AHA Comment Letter to DEA on Buprenorphine Telemedicine Prescribing Proposed Rule

The Honorable Anne Milgram
Administrator
Drug Enforcement Administration
Submitted electronically

Re: Proposed Rule for Expansion of Induction of Buprenorphine via Telemedicine Encounter

Dear Administrator Milgram, On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to provide feedback on the Drug Enforcement Administration’s (DEA’s) proposed rule for expansion of induction of buprenorphine via telemedicine encounter. We are submitting separate comments on the proposed rule regarding telemedicine prescribing of controlled substances when there has not been a prior in-person evaluation.

Buprenorphine is an opioid partial agonist used to treat individuals with opioid use disorder (OUD). It is the only Schedule III narcotic approved by the U.S. Food and Drug Administration for treatment of OUD; because it is an opioid, albeit of lower strength than other opioids like heroin, there is potential for misuse. However, data from the past several years demonstrates that increased access to buprenorphine — for example, via prescriptions issued by medical professionals using telehealth modalities — not only increases likelihood of recovery from OUD, but it also does not increase the likelihood of diversion (for misuse) of the substance.

We recognize and appreciate the DEA’s continued efforts to support the safe prescribing of controlled substances, including via telehealth and including during the COVID-19 public health emergency (PHE). Indeed, during the PHE, the DEA enacted certain flexibilities to ensure patients could continue to receive lifesaving medications via telehealth while minimizing exposure and preserving provider capacity. These flexibilities, including waiving the required initial in-person visit prior to prescribing controlled substances via telehealth and allowing the use of telephone evaluations to initiate buprenorphine prescribing, have proved critical in providing access to patients.

The Ryan Haight Act of 2008 outlined several categories where an in-person evaluation could be waived including but not limited to during PHEs (as was the case during COVID-19) and for other circumstances to be defined by regulation. Because the DEA waived the in-person evaluation criterion during the PHE, the agency now can integrate lessons learned from the pandemic to provide pathways for providers to continue to safely administer prescriptions, particularly buprenorphine for the treatment of OUD, virtually beyond the end of the PHE. Instead, the DEA proposes to impose burdensome restrictions and additional administrative requirements on providers and patients, which we are concerned will adversely impact patient access to medically necessary OUD treatment. Therefore, we have several recommendations, outlined below, that we believe would better maintain secure but accessible prescriptions for buprenorphine. Most importantly, we urge the DEA to expeditiously set forth a special registration process regulation to identify a pathway to waive in-person evaluations prior to the prescribing of controlled substances, especially buprenorphine, for practitioners who register with the DEA. Further, we strongly urge the DEA to extend the waivers for the in-person visit requirement for prescribing of controlled substances until it, with significant stakeholder input, develops and proposes such a process for prescribing controlled substances via telemedicine.

View the detailed letter below.