Join Aimed Alliance for a Free Advocacy Briefing on
S.3257 to Facilitate Access to Medication for Opioid Use Disorder (MOUD)
November 2, 2022 from 2PM-3PM ET.
Aimed Alliance will host a briefing on S.3257, a federal bill to facilitate access to medications for opioid use disorder (MOUD). The one-hour briefing is intended to inform and engage congressional staff, patient advocacy groups, professional associations, and other supporters of access to MOUD.
- K. Shiek Pal, Senior Counsel to Sen. Jeanne Shaheen, sponsor of S.3257
- Christopher McCann, Legislative Director for Rep. Madeleine Dean, sponsor of Section 264 of H.R. 7666
- Dr. Stacey Sigmon, Director, University of Vermont Center on Rural Addiction
- Michael Barnes, Counsel to Aimed Alliance, Principal Attorney at Sequel Health Law
Read our speaker’s bios here.
Public Health Rationale
The Centers for Disease Control and Prevention (CDC) reports that over 100,000 Americans died from drug poisonings in 2021. Two out of every three fatal drug poisonings in 2021 involved an opioid, driven by an increase in exposure to synthetic opioids, namely illicit fentanyl. As such, there continues to be an urgent need to ensure individuals with OUD can access life-saving treatments.
Buprenorphine for OUD
Buprenorphine is one of three prescription medications approved by the Food and Drug Administration (FDA) to treat opioid use disorder (OUD). It has been described as the “gold standard” for treating persons with OUD. Buprenorphine is available in daily oral tablets and films, and extended-release injections.
Successful treatment with buprenorphine requires patients to take their medication as prescribed. Patients who are prescribed and self-administer oral buprenorphine may have a higher risk of symptom recurrence if they skip doses or otherwise do not take their medication as directed. Injectable buprenorphine, on the other hand, is administered by a health care practitioner and delivers a steady dose of the medication over a specific duration of time.
Need for Legislation
Patient access to injectable buprenorphine is hindered by a provision of the federal Controlled Substances Act (CSA) that requires injectable MOUD to be administered to a patient no later than 14 days after the medication is delivered to the practitioner. Precisely timing the delivery, receipt, and administration of such formulations within a two-week window is too difficult given variables outside of a prescriber’s control, including health plan coverage and payment; shipment delays; and appointment scheduling, rescheduling, and attendance.
S.3257 will increase the 14-day limit to 60 days, allowing adequate time for patients, practitioners, pharmacies, and health plans to coordinate the administration of injectable buprenorphine for OUD.
Legislative Progress and Timeline
On June 22, 2022, the U.S. House of Representatives passed H.R. 7666 with broad bipartisan support. Section 264 of H.R. 7666 contains a provision expanding the 14-day limit to 60 days.
It is essential that the U.S. Senate pass S.3257 before the end of 2022. Otherwise, legislative advocacy must begin anew in 2023 while patients’ MOUD treatment options remain limited by the 14-day-rule.