Medicine in 2019 that “[t]he verdict is clear: effective agonist medication used for an indefinite period of
time is the safest option for treating OUD.”7
LARA’s proposed changes to the administrative rules for Substance Use Disorder Service Programs
would expand and enhance critical, life-saving access to agonist medications among Michiganders with
OUD. Vital Strategies submits this comment to outline its support for key changes in the draft rules and
offer several recommendations on how the rules can be further clarified or strengthened.
I. Key improvements in the proposed rules
a. Eliminating licensure barriers for prescribers of buprenorphine and facilitating
access for recipients
Widespread access to the agonist medication buprenorphine is an essential overdose prevention and
health promotion strategy. Providers who prescribe buprenorphine for OUD are already subject to
unique federal requirements that have been identified as a barrier to addressing the enormous unmet
need for evidence-based OUD treatment.8,9,10,11 It is imperative that states not impose additional
regulatory barriers that may further discourage providers from offering this life-saving medication to
people with OUD.
Vital Strategies applauds the proposed elimination of Rule 325.1303(3)(c) and of related provisions that
currently impose an additional licensure requirement under certain circumstances for buprenorphine
prescribing to treat OUD. Moreover, Proposed Rule 325.1331(2)(c) requires that applicants and
licensees maintain policies and procedures that include “referrals, including access to medication-
7 National Academies of Sciences, Engineering, and Medicine. Medications for opioid use disorder save lives. (Leshner AI,
Mancher M, eds.). Washington, DC: The National Academies Press; 2019.
8 The Drug Addiction Treatment Act of 2000 (DATA 2000) and its implementing regulations require practitioners to receive a
separate registration (commonly referred to as an X waiver) prior to prescribing buprenorphine for the treatment of opioid use
disorder. 21 USC § 823(g)(2). Only certain types of practitioners are eligible to receive an X waiver and must meet specified
certification or training requirements. 21 USC § 823(g)(2)(G)(ii)-(iv). Practitioners must attest to their capacity to provide,
directly or by referral, appropriate counseling and other appropriate ancillary services. 21 USC § 823(g)(2)(B)(ii)(II).
Additionally, providers are restricted in the number of patients they may treat with buprenorphine at any given time, 21 USC §
823(g)(2)(B)(iii), with further requirements related to practice setting and ancillary services for practitioners with higher patient
limits. See 42 CFR § 8.610-.655. Practice guidelines issued by the Department of Health and Human Services in April 2021
removed some, but not all, of these barriers for practitioners treating no more than 30 patients for OUD using buprenorphine,
and all practitioners are still required to obtain an X waiver prior to prescribing buprenorphine for OUD. 86 Fed. Reg. 22439.
9 Haffajee RL, Bohnert ASB, Lagisetty PA. Policy Pathways to Address Provider Workforce Barriers to Buprenorphine
Treatment. American Journal of Preventive Medicine. 2018;54(6):S230-S242.
10 Fiscella K, Wakeman SE, Beletsky L. Buprenorphine Deregulation and Mainstreaming Treatment for Opioid Use Disorder.
JAMA Psychiatry. 2019;76(3):229. doi:10.1001/jamapsychiatry.2018.3685
11 Oesterle TS, Thusius NJ, Rummans TA, Gold MS. Medication-assisted treatment for opioid-use disorder. Mayo Clinic
Proceedings. 2019;94(10):2072-2086. "[I]t is estimated that only 11% of patients with an opioid use disorder are prescribed
Food and Drug Administration (FDA)-approved medications for the disorder."
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