HHS Finalizes Rules on Telehealth Prescribing of MOUD

On January 31, the Department of Health and Human Services (HHS) finalized rules to allow buprenorphine prescribing through telehealth without in-person requirements permanently. The rules also allow for take-home doses of methadone. The regulatory update expands provider eligibility to prescribe to include nurse practitioners and physician assistants. Updated language around addiction has also been included in the changes. Additionally, the rule eased requirements for minors to access buprenorphine and methadone. At the announcement of the updates, HHS Deputy Secretary Andrea Palm said, “With these announcements, we are dramatically expanding access to life-saving medications and continuing our efforts to meet people where they are in their recovery journeys. The Biden-Harris Administration continues to take action to lower barriers to treatment and increase support for individuals and communities affected by opioids”. The rule will go into effect on April 2, 2024. This rule does not apply to the telehealth prescribing of controlled substances via telehealth rule, which remains in the Drug Enforcement Administration’s (DEA) jurisdiction.

Articles & Resources

SAMHSA-Biden-Harris Administration Marks Two Years of Advancement in HHS’ Overdose Prevention Strategy with New Actions to Treat Addiction and Save Lives

New NIH-Funded Study Examines Risk of Congenital Malformations from Buprenorphine and Methadone

On January 22, new NIH-backed research was released reviewing the risk of congenital malformations from buprenorphine and methadone treatments in the first trimester. Findings reflect that, while the risk remains low, these treatments are not without risk. The cohort study examined Medicaid beneficiary information on demographics, diagnosis, procedures, and other relevant health information, reviewing 13,360 pregnancies from 2000-2018. The analysis examined 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 pregnancies with first-trimester methadone exposure and found an 18% relative risk reduction in overall malformations. The malformations included cardiac malformations, ventricular septal defect, secundum atrial septal defect/non-prematurity-related patent foramen ovale, neural tube defects, clubfoot, and oral clefts, as well as secondary organ-specific malformations. The overall buprenorphine risk of malformation is 50.9 out of 1000 pregnancies (5.09%); with methadone the risk of malformation was 60.6 out of 1000 pregnancies (6.06%).

Articles & Resources

JAMA—First Trimester Use of Buprenorphine or Methadone and the Risk of Congenital Malformations

New Legislation Introduced to Combat ‘Gas Station Heroin’

On January 25, Representatives Jimmy Panetta (CA-19) and August Pfluger (TX-11) introduced The Scheduling Tianeptine and Analogues Now to Defend (STAND) Against Emerging Opioids Act. Tianeptine, commonly referred to as ‘gas station heroin,’ can lead to opioid-like highs and has the potential for dependence and overdose. The legislation would make tianeptine and its analogues Schedule III, requiring a prescription. The drug is used to treat depression in European, Asian, and Latin American countries; however, it is not approved by the Food and Drug Administration (FDA). The bipartisan legislation allows the FDA to make future regulatory decisions on the drug. Upon introduction, Rep. Panetta said, “Tianeptine, a potent opioid-like drug, poses alarming risks, and the ease of acquiring it-like candy-is a public health threat…By scheduling tianeptine under the Controlled Substances Act, the bipartisan STAND Against Emerging Opioids Act will help prevent the prevalence and abuse of this unregulated drug. As the opioid crisis continues to evolve, the federal government needs to actively monitor these types of emerging drugs as a threats to our public health and safety.”

Articles & Resources

Rep. Jimmy Panetta—Rep. Panetta Authors and Introduces Bipartisan Legislation to Help Prevent Abuse of Tianeptine

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

Axios—The opioid epidemic is costing Virginia billions

CancerNetwork—Substance Use Disorders Among Adult Cancer Survivors

CBS—Exclusive: New York City accounted for 10% of all fentanyl seized in the U.S. in 2023

JAMA—Recreational and Medical Cannabis Legalization and Opioid Prescriptions and Mortality

Vanderbilt University—Vanderbilt chemist Ben Brown awarded $2.375M to develop non-addictive painkillers with AI

Washington Examiner—Leading from the forefront of the fight against the overdose epidemic

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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