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42 CFR Part 8 Notice of Proposed Rulemaking - Frequently Asked Questions

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is proposing an update to the federal regulations that address opioid use disorder (OUD) treatment standards, as well as opioid treatment program (OTP) accreditation and certification standards. These standards are found in 42 CFR part 8, and this proposal would be the first substantial update to the OTP treatment and medication delivery standards in over 20 years. They are being proposed in order to expand access to care and to improve Americans’ experiences as they seek treatment for substance use disorder (SUD). This is in direct response to the overdose crisis and the proposal advances part of HHS’ Overdose Prevention Strategy. The proposed rule draws on evidence from over the last 20 years and from research and experience during the COVID-19 pandemic.

SAMHSA proposes to update Part 8 by removing stigmatizing or outdated language; supporting a more patient-centered approach; and reducing barriers to receiving care. For example, in March 2020, SAMHSA published flexibilities for the provision of take home doses of methadone and the use of telehealth in initiating buprenorphine in OTPs. Patients deemed stable by physicians have been able to take home up to 28 days’ worth of methadone doses; less-stable patients – again, so determined by their physicians – have received up to 14 days’ worth. These flexibilities represented the first substantial change to OTP treatment standards in more than 20 years. Under SAMHSA’s proposed NPRM for 42 CFR Part 8, these flexibilities would become permanent.

The isolation, anxiety and reduced access to resources experienced by many during the COVID-19 pandemic has exacerbated substance misuse and overdose deaths. According to provisional data from the Centers for Disease Control and Prevention (CDC), 107,560 Americans died from a drug overdose in the 12-month period ending in March 2022. ¹ Synthetic opioids (primarily illicitly manufactured fentanyl) appear to be the principal driver of overdose deaths, increasing 55 percent from 2019 to 2020 and further increasing 26 percent from 2020 to 2021. ² Overdose deaths involving cocaine also increased by 22 percent from 2019 to 2020.² These deaths are likely linked to co-use or mixing (by illicit producers) of cocaine with illicitly manufactured fentanyl or heroin. Treatment with medications for opioid use disorder (MOUD), particularly methadone and buprenorphine, significantly reduces opioid-related overdose mortality. ³ The rise in fentanyl use or exposure, concurrent substance misuse, as well as overdose deaths, necessitates changes to Part 8 that expand access to care, incorporate lessons learned from flexibilities provided as part of the COVID-19 public health emergency declaration (COVID-19 PHE), and promote engagement in OTP services. At the same time, the changes support oversight and accreditation standards as a means of promoting evidence-based care, while minimizing diversion and adverse patient outcomes.

The proposed rule draws on experience from the COVID-19 PHE, as well as decades of research. ^4,5,6,7,8The COVID-19 PHE necessitated changes to policy guidance and legal exemptions to protect the public’s health, promote social distancing, and support patient and staff safety among OTPs. In March and April 2020, SAMHSA published flexibilities in the provision of take home doses of methadone and the use of telehealth in initiating buprenorphine. ⁹ A growing body of research has demonstrated that these flexibilities facilitate access to treatment and eliminate criteria that promote stigma and discourage people from accessing care in OTPs. A recent study showed that patients who received increased take home doses allowed by these flexibilities saw positive impacts on their recovery, including being more likely to remain in treatment and less likely to use illicit opioids. ¹⁰ In addition to making these flexibilities permanent, the proposed changes reflect an accreditation and treatment environment that has evolved since Part 8 went into effect in 2001.

The proposed rule, if finalized, would make these flexibilities permanent and supports take home doses of methadone from entry into treatment. While the decision to provide take home doses of methadone rests with the treating practitioner, the proposed changes seek to promote clinical and person-centered decision-making. This is augmented through expanded access to telehealth services. The proposed changes support the use of telehealth across the continuum of care and across different interventions, including initiation of treatment with methadone. Peer-reviewed evidence and extensive feedback have demonstrated the safety and efficacy of the methadone take home flexibility and also the flexibility that supports initiation of buprenorphine via telehealth in OTPs.

With the proposed changes, SAMHSA seeks to: promote practitioner autonomy; remove stigmatizing or outdated language; support a patient-centered approach; and reduce barriers to receiving care. These elements have been identified in the literature and in feedback as being essential to promoting effective treatment in OTPs, and reflect an OTP accreditation and treatment environment that has evolved over the past 20 years.

Accordingly, SAMHSA proposes updates that reflect evidence-based practice, language that aligns with current medical terminology, effective patient engagement, and promotion of a skilled and robust workforce providing services in OTPs. To this end, the definition of a qualifying practitioner has been expanded to include a provider who is appropriately licensed by the state to prescribe (including dispense) covered medications and who possesses an appropriate waiver. The current Part 8 rule defines a practitioner as being: “a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C.823(g)(2).” During the COVID-19 PHE, this was formally expanded to align with broader definitions of a practitioner (nurse practitioners, physician assistants, etc.), and OTPs reported that this change was essential in supporting workflow and access.

Admission criteria have been updated to remove significant barriers to entry, while also defining the scope and purpose of the ‘initial’ and ‘periodic’ medical examinations. The proposed rule also includes new definitions to expand access to evidence-based practices such as split dosing, telehealth and harm reduction activities. Further to this, outdated terms such as “detoxification” have been revised to remove stigmatizing language.

The proposed changes would also revise the provision containing the criteria for take home doses of methadone. This includes removal of consideration of the length of time an individual has been in treatment, as well as rigid reliance on toxicology testing results that demonstrate complete and sustained abstinence from all substances prone to misuse. Based on the clinical judgment of the treating provider, patients may be eligible for take home doses of methadone upon entry into treatment. This recognizes the importance of the practitioner-patient relationship, and is consistent with evidence-based treatment standards. It also allows for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation. The proposed changes also promote the chronic disease model of management, while removing barriers to providing individualized care. This is designed to encourage patient engagement and to reduce the need for individuals to attend an OTP each day to receive medication.

To expand access to care, SAMHSA proposes to update OTP admission criteria. This includes removal of the one-year requirement for opioid addiction before admission to an OTP, in favor of consideration of a person’s problematic patterns of opioid use. In conjunction with updated standards that include extended take home doses of methadone and access to telehealth, this is expected to expand access while also improving retention in treatment.

The proposed rule would eliminate the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients provide annual reports to SAMHSA. The proposed rule also allows waivered practitioners within OTPs to initiate buprenorphine via telehealth.

Accreditation and certification standards have been reviewed to codify the use of online/electronic forms, to eliminate types of certification that are no longer in use, and to update existing types of certification in a manner that reflects established practice. SAMHSA also proposes to update the manner in which information is shared by Accreditation Bodies, particularly in those circumstances where there have been changes or violations in accreditation. The proposed rule also clarifies administrative issues pertaining to mobile medication units and interim treatment.

While the proposed changes would provide flexibility in how methadone might be provided to patients receiving treatment for opioid use disorder OUD in OTPs, analysis of data on fatal overdoses from January 2019 to August 2021, published in JAMA Psychiatry, demonstrate that the COVID-19 PHE methadone take-home flexibility did not lead to more deaths involving methadone. ¹¹ Further to this, a recent survey found that diversion of methadone is low among patients receiving take home doses under the COVID-19 PHE flexibility. ^12,13 Indeed, analysis of the relevant data indicates that the actual level of misuse, diversion or harm from methadone is more likely to occur when it is prescribed for pain as opposed to OUD, and that the rate of diversion is lower than that of oxycodone or hydrocodone.¹⁴ Additionally, the NPRM does not propose removing guardrails around the provision of take home doses of methadone. Instead, they would be updated to align with current evidence, particularly studies undertaken and experience gained during the past 2 years.

These changes are also supported by principles underlying the care of patients in other specialty areas of medicine and settings where controlled medications are used. The flexibilities provided during the COVID-19 PHE have been met with widespread support among patients, OTPs and state authorities. For example, patients reported that increased take home doses of methadone left them feeling more respected as responsible individuals. In a recent meeting, state authorities reported that the flexibilities were appreciated by patients and OTPs alike, with no significant change in rates of diversion seen since the COVID-19 PHE was declared.

The decision to provide take home doses of methadone rests with the treating practitioner, and proposed changes support person-centered decision making, practitioner autonomy and the responsibility to exercise clinical judgment. In this way, the proposed rule provides OTP practitioners with evidence-based guidance, and they are supported in basing their decision on knowledge of the individual, their medical comorbidities, the stability of their home life and social connections, comfort with taking unsupervised doses of methadone and also risk profile. This is in line with evidence-based models of chronic disease management found across different health conditions. However, these new changes do not supersede State rules and regulations in which the OTP is licensed.

Historically, under Part 8, patients receiving care in an OTP have been eligible for a take home dose of methadone for one day out of the week on which the OTP may be closed. The COVID-19 PHE flexibility permitted up to 14 days of take home medication for some patients and up to 28 days of take home medication for other patients, regardless of their time in treatment. Based on the experience of the past 2 years, and the evidence that has been generated as a result, SAMHSA has proposed changes to Part 8 that support clinical judgment and person-centered care. Clinical judgment includes consideration of the risks and benefits of providing take home methadone doses, even starting at the beginning of treatment.

Practically, this might mean that a patient starting methadone for the first time may need to be seen more frequently at the OTP, as the dose is being increased, to safeguard against the dose causing undue or adverse effects, and that the person’s OUD is responding as anticipated. It also may mean that patients may safely be able to receive take home doses of methadone upon admission into treatment. Basing those decisions on clinical judgment of the treating provider recognizes the importance of the practitioner-patient relationship, and is consistent with modern standards of care for other health conditions treated with controlled medications. It also allows for greater flexibility in creating plans of care that promote recovery activities such as employment, while also eliminating the barrier of frequent visits for individuals without access to reliable transportation.

No. Methadone is dispensed at the OTP, and so the first dose of methadone, at a minimum, would be provided under direct supervision. This ensures patient safety, that the medication is tolerated, and that the patient has connected with other members of the treatment team. This follows an initial audio-visual telehealth appointment with the OTP practitioner who orders the methadone to be dispensed after having established, at a minimum, the nature, diagnosis, and severity of the person’s opioid use disorder and accompanying opioid withdrawal, and any contraindications to starting methadone. Additionally, the practitioner must ensure that the individual properly understands the safety aspects of methadone, including safe transportation and storage of any take home doses, how the dose will safely be increased, and other precautions the person can take as they start treatment (e.g. having naloxone on hand). These activities altogether are unlikely to occur within the confines of a 15-minute encounter.

No, this is not possible. The proposed rule does, however, allow for the use of audio-visual telehealth for any new patient who will be treated by the OTP with methadone if a qualified program practitioner determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform. The proposed rule does not permit use of audio-only telehealth because methadone, in comparison with buprenorphine, holds a higher risk of sedation, especially if taken by someone who already is experiencing some drowsiness. Mild drowsiness is easier to identify through an audio-visual telehealth platform than an audio-only interaction . This promotes patient safety, while also allowing for the use of telehealth technology.

States may have or draft regulations that are more restrictive than the proposed rule. However, proposed changes to 42 CFR part 8 were created in an evidence-based manner and are designed to be delivered as a suite of interventions. These interventions support engagement in treatment, and activities, such as employment, that are associated with recovery. The proposed changes also support practitioner and patient engagement in care. This is not only an important way to keep people in treatment, but it also fosters a dynamic and person-centered workforce.

The changes proposed in this rule would not currently allow for methadone prescribing outside of an OTP nor automatically permit patients to receive methadone through a prescription in a pharmacy.

The proposed changes to 42 CFR part 8 have been published in the Federal Register, with 60 days to provide comments. After this time, HHS and SAMHSA will respond to comments and make changes to the proposed rule as needed. The final rule is then published. The effective date of the rule will be 60 days after publication of the Final Rule, and the compliance date would be 6 months after the effective date. Entities subject to the final rule would have until the compliance date to achieve compliance with this rule.

The proposal, on display with the Federal Register, is viewable at https://public-inspection.federalregister.gov/2022-27193.pdf. Public comment on the proposed regulatory changes may be made until February 14, 2023. Instructions on providing comments can be found in the Federal Register, and SAMHSA welcomes your review and input.