Extracted from Law360
Substance use disorder treatment providers are celebrating victories for telehealth and opioid use disorder, or OUD, treatment with a long-awaited final rule that went into effect on April 4.
On Feb. 2, the Substance Abuse and Mental Health Services Administration published a final rule, "Medications for the Treatment of Opioid Use Disorder."[1]
SAMHSA issued a proposed rule in December 2022[2] and consulted with the U.S. Drug Enforcement Administration when developing the final rule. The agency received nearly 400 comments responding to its notice of proposed rulemaking, and the final rule includes several changes based on public and stakeholder input.
Notably, the final rule applies to certified opioid treatment programs, or OTPs, but does not apply to virtual prescribing of controlled substances more broadly, which falls under the DEA's regulatory purview. But that does not diminish the changes — which most stakeholders will view positively — that the final rule makes to the existing regulations for OTPs under Title 42 of the Code of Federal Regulations, Part 8.
The final rule also makes permanent some flexibilities established during the COVID-19 public health emergency, which stakeholders generally supported to expand access to patient care and evidence-based OUD treatment during the public health emergency.
The final rule removes all language and rules related to the Drug Addiction and Treatment Act waiver from the regulations in accordance with the Consolidated Appropriations Act.
While the final rule is lengthy, a few of its many changes and their impacts on patients and providers are worth highlighting.
Terminology Changes
Readers familiar with proposed iterations of the rule will immediately notice a change in terminology.
The final rule aligns with current precedent by removing certain terms and taking a patient-centered approach. For instance, in the final rule, the modern, recognized term for "medications for opioid use disorder," or MOUD, replaces the outdated language using "medication-assisted treatment."
Some of the definitions within the final rule have also been modified.
The final rule clearly acknowledges that several terms are stigmatizing, such as "narcotic drugs" and "detoxification treatment." SAMHSA replaced these terms with "opioid agonist medications" and "withdrawal management."
In response to comments in the final rule, SAMHSA indicated the potential for further action to eliminate harms suffered by individuals struggling with and in recovery from substance use disorders, noting that changing the language alone is not enough to eliminate stigma and discrimination.
SAMHSA will continue its work with its federal, state, local, tribal and territorial partners to address health inequities and promote justice through its programs, services and regulations.
Telehealth
In addition to finalizing some COVID-19-related flexibilities, the final rule takes additional steps forward when it comes to telehealth by updating requirements for the provision of medications.
Under the final rule, providers can screen patients for the initiation of buprenorphine by using audio or audiovisual telehealth platforms, if certain criteria are met. Similar changes are included in the requirements for methadone initiation, although only audiovisual telehealth platforms are permitted.
SAMHSA stated the following in support of these barrier reductions: "Telehealth is an evidence-based practice that has been shown to be safe and effective. Its use expands access to care and promotes activities known to support recovery such as employment."[3]
These changes in the final rule will ultimately increase patient access to medications that aid recovery and seek to make MOUD treatment easier for patients and providers alike.
Additional Barrier Reductions
Considering the comments made on the previously proposed rule, stakeholders will likely applaud the final rule's inclusion of take-home dose provisions and the softening of treatment requirements for minors.
Some patients may now receive take-home doses of methadone, including at the initiation of treatment, e.g., seven take-home doses of methadone for patients new to treatment. The final rule also reduces restrictions on interim treatment by expanding the opioid treatment programs that may provide interim treatment, and by extending the interim treatment period from 120 to 180 days.
The final rule removes barriers that previously required minors to fail withdrawal before they could receive methadone or buprenorphine. SAMHSA noted: "There is nothing stated within the Federal regulations or statutes that limits the number of times a person can initiate treatment with methadone or any other medication."[4]
The final rule rests on the requirement that OTPs use qualified personnel and accepted medical criteria to initiate treatment.
The final rule also expands access by expanding who can order medications for OUD. A practitioner is defined as "a health care professional who is appropriately licensed by a State to prescribe and/or dispense medications for opioid use disorders and, as a result, is authorized to practice within an OTP."[5]
Therefore, nurse practitioners and physician assistants can now order such medications, assuming doing so complies with state laws.
It's important to note that not all states permit nurse practitioners and physician assistants to prescribe methadone, and some states may require a certain level of physician supervision to do so. Therefore, notwithstanding the additional flexibilities provided in the final rule, practitioners must continue to adhere to state requirements that may apply to the provision of methadone and scope of practice.
Further, the final rule doesn't apply to the prescribing of methadone for OUD outside OTPs. SAMHSA states in the final rule that it continues to work with federal partners to explore ways to expand access to medications for OUD, indicating that there may be future action from the agency on such policy.
Accreditation
The final rule clarifies the interactions with OTP-accrediting bodies, expectations surrounding follow-up from those accrediting bodies, and the criticality of findings from those accrediting bodies.
SAMHSA closely monitors OTP-accrediting bodies, and the final rule strengthens that oversight to attempt to ensure the accrediting bodies are consistently interpreting and applying Title 42 of the Code of Federal Regulations, Part 8.
SAMHSA will continue to inspect a sample of accredited OTPs and receive OTP surveys containing deficiencies.
The final rule prescribes a time frame for the accrediting bodies to follow when they are made aware an OTP isn't meeting accreditation standards. For example, accrediting bodies must contact the OTP regarding noncompliance within 60 days and prescribe a corrective action period of no more than 180 days.
The final rule also clarifies SAMHSA's expectations of communications from accrediting bodies and makes clear that noncritical findings during a survey do not result in a one-year accreditation.
Conclusion
These flexibilities represent the first substantial change to OTP treatment and medication delivery standards in more than 20 years, and their role in facilitating access to treatment is supported by research.
While this is a significant step in expanding access to medications for OUD and reducing stigma, SAMHSA's references in the final rule to its continuing work to ensure more equitable access to care suggest the potential for expansion of its finalized policies, although it is unclear when that would be.
Based on feedback submitted by commenters, it appears that this final rule is generally a win for treatment providers, advocates and patients, although it must be recognized that the rule is quite narrow in scope and does have some limitations.
For example, some commenters suggested SAMHSA expand methadone treatment outside OTPs. While the final rule does not apply to programs beyond OTPs, which is not surprising given the rigorous requirements that OTPs must meet for accreditation and licensure purposes, we fully expect the efforts to expand flexibilities related to telemedicine and substance use disorder treatment to continue.
The updated policies in the final rule will be especially impactful for individuals living in rural areas and low-income populations who struggle to access reliable transportation to receive in-person care.
The final rule aligns with one of the Biden administration's priorities to expand access to substance use disorder treatment. Miriam Delphin-Rittmon, the U.S. Department of Health and Human Services' assistant secretary for mental health and substance use, said:
This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders and this update will help those most in need.[6]
The Biden administration also highlights that this final rule not only reduces barriers to medication but removes stigmatizing and outdated language, and revises definitions to align with current medical usage.
The rules went into effect on April 4, with an Oct. 2 compliance date.
[1] See 89 Fed. Reg. 7528 (Feb. 2024).
[2] See 87 Fed. Reg. 77330 (Dec. 2022).
[3]See SAMHSA's "The 42 CFR Part 8 Final Rule Table of Changes." Available at https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/42-cfr-part-8/final-rule-table-changes.
[4] 89 Fed. Reg. 7528, 7536 (Feb. 2024).
[5] See 89 Fed. Reg. 7528, 7551 (Feb. 2024).
[6] See "Biden-Harris Administration Marks Two Years of Advancements in HHS' Overdose Prevention Strategy with New Actions to Treat Addiction and Save Lives." Available at https://www.hhs.gov/about/news/2024/02/01/biden-harris-administration-marks-two-years-advancements-hhs-overdose-prevention-strategy-new-actions-treat-addiction-save-lives-press-release.html#:~:text=Major%20provisions%20of%20the%20final,take%2Dhome%20doses%20of%20methadone.