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Changes to Remote Opioid Treatment Regulations and House Bill 300

Dylan Armstrong
Public Policy Fellow
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November 13, 2023
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Opioid Treatment Programs (OTPs) operating in Ohio are subject to federal and state regulations. At the federal level, the Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S. Department of Health and Human Services (HHS) and 42 Code of Federal Regulations (CFR) part 8 regulate Medication Assisted Treatment for Opioid Use Disorders, standards, and certification of OTPs. At the state level, this falls to the Ohio Department of Mental Health and Addiction Services (OhioMHAS). Requirements to operate OTPs are contained in Ohio Revised Code Sections 5119.37 and 5119.371.Historically, patients receiving treatment from OTPs have been required to physically go to the clinics daily to receive their medication. This practice became infeasible during the COVID-19 pandemic.

Federal Changes

In response to the infeasibility of daily trips to OTPs during the pandemic, in March and April of 2020, SAMHSA issued flexibilities for OTPs to reduce the risk of COVID infections among patients and providers. This included methadone take-home flexibilities and an in-person physical evaluation exemption. The in-person evaluation exemption exempts OTPs from the required in-person physical for patients who will be treated with buprenorphine if the provider determines that an adequate evaluation can be completed through telehealth services.The methadone take-home flexibilities allowed states to:

  1. Request blanket exceptions for all stable patients in an OTP to receive 28 days of take-home unsupervised doses of the patient’s medication for opioid use disorder.
  2. Request up to 14 days of take-home unsupervised medication for those patients who are less stable but who the OTP believes can safely handle this level of take-home medication.

Map of State Concurrence with flexibilities and exemptions. Data from SAMHSA.In November 2021, SAMSHA announced that the flexibilities would be extended for an additional year while a permanent solution is developed. SAMSHA reports that preliminary research showed that the increase in take-home doses of methadone was not associated with negative treatment outcomes and that stakeholders reported improved patient satisfaction, fewer incidents of misuse or diversion of medication, and increased engagement with treatment. Additionally, stakeholders stated that the flexibilities promote recovery-oriented care by increasing access for individuals who live farther away from an OTP or lack reliable transportation as fewer visits are required for successful treatment. Fewer visits also mean people have more time to work, care for others, and conduct other routine activities in their daily lives.In December 2022, SAMSHA issued a notice of proposed rulemaking to update 42 CFR Part 8, which regulates Medication Assisted Treatment for Opioid Use Disorders, to expand access to Opioid Use Disorder Treatment and help close the gap in care. Primarily, the rule proposes making permanent the flexibilities pertaining to unsupervised doses of methadone and the initiation of buprenorphine through telemedicine.

The rule proposes making permanent the flexibilities pertaining to unsupervised doses of methadone and the initiation of buprenorphine through telemedicine.

Prior to the COVID-19 Public Health Emergency expiring on May 11, 2023, HHS released a fact sheet highlighting telehealth flexibilities and the COVID-19 Public Health Emergency. It noted SAMSHA will continue to waive the in-person physical examinations requirement until May 11, 2024, and provided new guidance for methadone take-home doses that is in effect until May 11, 2024, or until HHS publishes final rules revising 42 CFR part 8. It established that unsupervised take-home doses of methadone may be provided in accordance with the following treatment standards:

  • For someone who has been in treatment 0-14 days, up to seven unsupervised take-home doses of methadone may be provided to the patient.
  • For treatment days 15-30, up to 14 unsupervised take-home doses of methadone may be provided to the patient.
  • From 31 days in treatment, up to 28 unsupervised take-home doses of methadone may be provided to the patient.

State Changes

House Bill 300, sponsored by Representatives Rachel Baker (D-Cincinnati) and Sharon Ray (R-Wadsworth), would establish a two-year pilot program within OhioMHAS to provide grant funding to OTPs for remote methadone treatment. Funding includes $750,000 in each FY 2024 and FY 2025 and will assist in the procurement of a remote methadone treatment vendor. The legislation requires eight accessibility and security requirements that the vendor must offer and includes a reporting requirement within six months of the pilot program concluding.

House Bill 300 would establish a two-year pilot program within OhioMHAS to provide grant funding to OTPs for remote methadone treatment.

At H.B. 300’s first hearing in the House Behavioral Health Committee, the sponsors noted that the most effective treatment for opioid use disorder is medication-assisted treatment and that by increasing the availability of take-home doses the majority of barriers that cause patients to fall out of treatment; transportation, which can take upwards of 30 minutes to an hour, work schedules, stigma, and childcare, can be reduced.SAMSHA’s OTP directory shows that there are 118 active programs in Ohio where individuals can receive opioid treatment. While active programs are present in 43% of Ohio counties, this still leaves many communities without a provider. For example, if a patient lives in Defiance, their options are to drive about an hour to either Toledo or Lima for treatment. H.B. 300 would allow this patient to limit these trips as they could receive treatment virtually.

Map of active OTPs in Ohio. Data provided by SAMSHA.The Center for Community Solutions will continue to monitor H.B. 300’s progress and state regulations as the federal government continues to update 42 CFR Part 8, and advocate for policies that increase access to care.

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