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BPC Comments on DEA Proposed Rules

While the opioid crisis began in the 1990s, the efforts to combat it continue almost three decades later. The crisis has and continues to change: What started with overprescribing and a death toll of 20,000 in the early 2000s has morphed into a battle against illicit fentanyl and over 100,000 lives lost each year. Earlier this month, the Office of National Drug Control Policy (ONDCP) announced the designation of fentanyl mixed xylazine as an emerging threat, the first use of the emerging threat designation authority since its passage by Congress in 2018. The changing landscape of the opioid crisis does not stop there.

In 2023, it’s not just new drugs that need to be considered in the opioid crisis but also the mode of treatment. Before the COVID-19 pandemic, over 85% of patients with substance use disorder were not receiving care. COVID-19 and subsequent lockdowns drastically changed care delivery, including treatment for those with opioid use disorder (OUD), moving treatment from mostly in-office visits to virtual check-ins with health care providers. Initial data from the pandemic indicate that access to virtual treatment reduced the risk of overdose death by 33%.

As evidence continues to emerge, policymakers and agencies need to consider how access to virtual behavioral health care will play into the fight against opioids, including impacting people’s access to care and health outcomes.

Given BPC’s vast work in behavioral health and telehealth policy, members of our Health Program recently responded to two Drug Enforcement Agency (DEA) proposed rules involving telemedicine.

Expansion of induction of buprenorphine via telemedicine encounter (RIN 1117-AB78)

Our recommendations include:

  • Extension of the current teleprescribing flexibilities through December 31, 2024, under the opioid crisis public health emergency
  • Formal evaluation of the impacts of teleprescribing flexibilities on public health and safety
  • Development of special registration authorized in Ryan Haight Act of 2008
  • Expanded prescribing training for eligible providers

Full comments available online.

Telemedicine prescribing of controlled substances when the practitioner and the patient have not had a prior in-person medical evaluation (RIN 1117-AB40)

Our recommendations include:

  • Leveraging virtual check-ins as an alternative to in-person visits when appropriate
  • Requiring that non-cancer, non-hospice patients have at least one medical evaluation before a prescription is issued
  • Use data from proposed labeling requirement to develop a special registration

Full comments available online.

BPC’s Health Program comments on tele-prescribing of controlled substances as well as our recent input on ONDCP’s 2024 National Drug Control Strategy help regulators develop research-driven, bipartisan policies that ensure safe and accessible patient care.

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