Medications for the Treatment of Opioid Use Disorder

AGENCY:

Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Department of Health and Human Services (HHS or “the Department”) is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations regarding medications for the treatment of opioid use disorder.

DATES:

Comments due on or before February 14, 2023.

ADDRESSES:

Written comments may be submitted through any of the methods specified below. Please do not submit duplicate comments.

• Federal eRulemaking Portal: You may submit electronic comments at https://www.regulations.gov. Follow the instructions at https://www.regulations.gov for submitting electronic comments. Attachments should be in Microsoft Word or Portable Document Format (PDF), and please refer to RIN 0930-AA39 in all comments.

• Regular, Express, or Overnight Mail: You may mail written comments (one original and two copies) to the following address only: The Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, 5600 Fishers Lane, Room 13-E-30, Rockville, MD 20857.

Note:

Due to the COVID-19 pandemic, SAMHSA notes receipt of mail may be delayed and encourages submission of comments electronically to the docket.

Inspection of Public Comments: All comments received by the accepted methods and due date specified above may be posted without change to content to https://www.regulations.gov, which may include personal information provided about the commenter, and such posting may occur after the closing of the comment period. However, the Department may redact certain content from comments before posting, including threatening language, hate speech, profanity, graphic images, or individually identifiable information about a third-party individual other than the commenter. Because of the large number of public comments normally received on Federal Register documents, SAMHSA is not able to provide individual acknowledgments of receipt. Please allow sufficient time for mailed comments to be received timely in the event of delivery or security delays. Comments submitted by fax or email, and those submitted after the comment period will not be accepted.

FOR FURTHER INFORMATION CONTACT:

Robert Baillieu, MD, MPH, Physician and Senior Advisor, SAMHSA/CSAT, 5600 Fishers Lane, Room 13-E-30, Rockville, MD 20857, Phone: 202-923-0996, Email: Robert.Baillieu@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION:

The discussion below includes an Executive Summary and overview describing the need for the proposed rule changes, a section-by-section description of the proposed modifications, and the impact statement and other required regulatory analyses. The Department solicits public comment on all aspects of the proposed rule. Persons interested in commenting on the provisions of the proposed rules can assist the Department by preceding discussion of any particular provision or topic with a citation to the section of the proposed rule being discussed.

Executive Summary

A. Overview

The Controlled Substances Act (CSA), under 21 U.S.C. 823(g)(1), requires “practitioners who dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment” to “obtain annually a separate registration for that purpose” except as provided under 21 U.S.C. 823(g)(2). Section 823(g)(1) also provides that, “[t]he Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment (or both)” if, among other things, the applicant “is determined by the Secretary to be qualified (under standards established by the Secretary [of HHS]) to engage in the treatment with respect to which registration is sought[,]” and “if the Secretary determines that the applicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment.” 21 U.S.C. 823(g)(1)(A)-(C). The standards authorized under section 823(g)(1) have been published as regulations under part 8 of title 42 of the Code of Federal Regulations (42 CFR part 8 or “part 8”). Among other things, these regulations establish the procedures by which the Secretary of HHS determines whether a program is qualified to dispense opioid agonist medications in the treatment of opioid use disorders, and standards regarding the appropriate quantities of opioid agonist medications that may be provided for unsupervised use by individuals undergoing such treatment. See 42 CFR 8.1. In addition, “a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication” that is also “registered under 21 U.S.C. 823(g)(1)” is described as an “Opioid Treatment Program” (OTP). See 42 CFR 8.2. The statue, at 21 U.S.C. 823(g)(2), also authorizes a waiver from the registration requirements of 21 U.S.C. 823(g)(1) for qualifying practitioners seeking to dispense or prescribe schedule III, IV, or V controlled substances that are Food and Drug Administration (FDA)-approved for use in “maintenance and detoxification treatment.” Practitioners with a waiver under section 823(g)(2) are limited in the number of patients with opioid use disorder they may treat at any one time, and depending on the practitioner's experience or qualifications, this statutory limitation is set at either 30, 100, or 275. See 21 U.S.C. 823(g)(2)(B)(iii). The Secretary is also authorized to change the patient limitations by regulation, and qualifying practitioners must satisfy the requirements of 42 CFR 8.610 through 8.655 “(or successor regulations)” in order to treat up to 275 patients, which is the maximum number under existing law. See 21 U.S.C. 823(g)(2)(B)(iii)(II)(dd).

In this NPRM, the Department proposes to modify certain provisions of part 8 to update OTP accreditation and certification standards, treatment standards for the provision of medications for opioid use disorder (MOUD) as dispensed by OTPs, and requirements for individual practitioners eligible to dispense (including by prescribing) certain types of MOUD with a waiver under 21 U.S.C. 823(g)(2).

The proposal draws on experience from the COVID-19 Public Health Emergency (PHE), as well as more than 20 years of practice-based research. The COVID-19 PHE necessitated changes to policy guidance and legal exemptions to protect the public's health, promote social distancing and to preserve patient and staff safety among OTPs. In March 2020, SAMHSA published flexibilities in the provision of unsupervised doses of methadone and the use of telehealth in initiating buprenorphine. These flexibilities represented the first substantial change to OTP treatment and medication delivery standards in over 20 years. 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 from OTPs.

This proposed rule not only makes these flexibilities permanent, but also updates standards to reflect an accreditation and treatment environment that has evolved since part 8 went into effect in 2001. Accordingly, the Department is proposing to update part 8 to: promote practitioner autonomy; remove stigmatizing or outdated language; create a patient-centered perspective; 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.

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 a waiver under 21 U.S.C. 823(g)(2). Admission criteria have been updated to remove significant barriers to entry, such as the one-year requirement for opioid use disorder (OUD), 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 Department promotes practitioner autonomy and individualized care by proposing to revise the provision containing the criteria for unsupervised 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 unsupervised, take home doses of methadone upon entry into treatment. This recognizes the importance of the practitioner-patient relationship, and is consistent with modern 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.

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. Part 8 has also been updated to facilitate information sharing between Accreditation Bodies and SAMHSA, 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.

The proposed changes seek to make treatment in OTPs more accessible to patients, easier to deliver for providers and supportive of evidence-based and patient-centered care. In proposing these changes, SAMHSA has relied on published evidence, stakeholder feedback and the need to expand access to care in the face of a growing overdose epidemic, exacerbated by the COVID-19 PHE. This is brought further into focus by the HHS declaration of a public health emergency for the opioid crisis which has been regularly renewed since 2017. The proposed changes are expansive but are focused on permanently implementing existing flexibilities and updating practices. In this way, SAMHSA believes that much of what is proposed in the rule will not represent a significant burden for OTPs and, in fact, will offer many benefits to providers and patients. The proposed rule, therefore, supports OTPs in their on-going provision of equitable and evidence-based care to often marginalized patients with OUD. The proposed rule also is consistent with the HHS Overdose Prevention Strategy which calls for increasing access to and the uptake of evidence-based treatments for substance use disorders.

B. Effective and Compliance Dates

The proposed effective date of a final rule would 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.

C. Summary of Major Proposals

The Department proposes the following changes to 42 CFR part 8 that revise, delete, replace, or add sections. This section summarizes major proposals in this NPRM. Additional proposed revisions are not listed here because they are not considered major. All proposed changes are discussed in detail in section III of this NPRM:

1. Heading.

The heading of part 8 has been changed from Medication Assisted Treatment for Opioid Use Disorders to Medications for the Treatment of Opioid Use Disorder to reflect currently accepted medical terminology and to remove language that is widely viewed to be stigmatizing.

2. Subpart A.

Subpart A currently addresses accreditation and includes steps that accreditation bodies must follow to obtain approval to accredit OTPs. It also sets forth accreditation bodies' responsibilities, including the use of accreditation elements, during accreditation surveys. In the proposed rule, these specifications are relocated to subpart B, which still would include Certification of Opioid Treatment Programs. The proposed rule limits subpart A to the preamble and definitions.

3. Section 8.1—Scope.

Revised § 8.1 to reflect modern medical terminology, to detail updated acronyms, and for clarity. Of note, the term medication assisted treatment (MAT) has been updated to MOUD, and the term treatment program has been changed to opioid treatment program throughout the proposed rule.

4. Section 8.2—Definitions.

Revised § 8.2 to add and update definitions. Added definitions include: care plan; harm reduction; individualized dose; long-term care facility; recovery support services; split dosing; and telehealth. Existing definitions updated include: comprehensive treatment; medication for opioid use disorder; and practitioner. The term detoxification treatment is removed and replaced with withdrawal management.

5. Section 8.3—Application For Approval as an Accreditation Body.

Added details of policies and procedures expected of accreditation bodies, particularly that accreditation bodies shall include staff physician(s) with experience in treating OUD with MOUD in their survey team. A correction has been made to the email address to which the accreditation application is submitted. The current rule calls for the accreditation bodies' training policies to be provided as part of their application process. Furthermore, this regulation would be updated to ensure that accreditation bodies provide training policies specifically related to training of survey team members. In addition to state or territorial governments, the proposed rule also provides for Indian Tribes to apply for approval as an accreditation body.

6. Section 8.4—Accreditation Body Responsibilities.

Amended to clarify expectations for cooperation of accreditation bodies with SAMHSA's oversight. These include steps to be taken by accreditation bodies in response to OTPs that are found to not be complying with accreditation or certification standards, such as follow up on corrective measures and confirmation of timely corrections. Time frames are also established for submission of survey reports. The proposed rule adds a requirement that all records of accreditation activities be made available to SAMHSA upon request. Current requirements regarding accreditation body follow up on complaints are maintained, but the proposed rule adds a requirement that accreditation bodies notify SAMHSA of all aspects of a complaint response within 5 days of receipt. The current rule requiring surveyors to recuse themselves from surveys due to conflict of interest is amended to clarify that such conflicts must be documented by the accreditation body and made available to SAMHSA.

7. Section 8.11—Opioid Treatment Program Certification.

This section is amended to update categories of certification, to clarify SAMHSA's expectation that OTPs maintain certification, and to establish procedures for OTPs whose certification has lapsed. Current terms for the extension of certification are amended to clarify the circumstances in which an extension could be requested, and the means of requesting an extension are defined in the proposed rule. The proposed rule also updates the certification application process to reflect the shift from paper applications to electronic submission, and the email address for submission of supporting documents is corrected.

The proposed rule removes “transitional certification” which expired as a category of certification in 2003. The wording of “provisional certification” is amended to clarify that it is a category of certification available only to new programs that have not been previously certified, and a new category of “conditional certification” has been added for OTPs that have received a one-year conditional accreditation status from an accrediting body—an organization that has been approved by the Secretary of HHS to accredit OTPs—in order for operations to continue or resume as the OTP takes steps needed to achieve permanent certification. The criteria for granting certification extensions outside of routine certification renewals has been expanded to address extensions needed under extraordinary circumstances. The grammar used in describing procedures for requesting an extension was revised.

The applicability of Health Insurance Portability and Accountability Act (HIPAA) privacy protections have been explained, along with clarification that changes in the status of the program sponsor or medical director must be submitted to SAMHSA in writing. The chapter of the Controlled Substances Act with which OTPs are expected to comply has been added; the chapter number is not included in the current version of the rule.

The conditions for approval of interim treatment have been amended to increase the duration of interim treatment from 120 days to 180 days, with the stipulation that individuals shall not be discharged without the approval of an OTP practitioner while awaiting transfer to a comprehensive treatment program. A reference to section 1923 of the Public Health Service Act (21 U.S.C. 300x-23) is removed. The proposed rule also shifts the need to seek approval from the `chief public health officer' of the state in which the OTP operates to the State Opioid Treatment Authority in the state in which the OTP operates.

The services that can be provided in medication units have been clarified to explicitly allow the full range of OTP services, based on space and privacy available in the medication unit.

8. Section 8.12—Federal Opioid Use Disorder Treatment Standards.

Revisions of treatment standards incorporated in this section aim to improve access to treatment, improve patient satisfaction and engagement in services and support use of clinical judgment in decision-making. In several instances, stigmatizing language such as “legitimate treatment use” of controlled substances, has been removed and patient-centered language is added.

The paragraph on staff credentials is amended to expand the definition of “qualifying practitioners” to a “physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife who is appropriately licensed by a State to prescribe covered medications and who possesses a waiver under 21 U.S.C. 823(g)(2).” The expectation that all licensed and credentialed staff maintain licensure and/or certification has been added.

Criteria for admission to treatment removes reference to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV and eliminates the requirement for a one-year history of OUD. The proposed rule instead specifies that the individual should either: meet diagnostic criteria for active moderate to severe OUD; that the individual may be in OUD remission; or at high risk for recurrence or overdose. The section is amended to assure that the basis for the admission decision is documented in the patient's record. In recognition of the use of telehealth and its limitation in obtaining physical signatures, the requirement to obtain written patient consent to treatment is removed. Consent may be provided verbally or electronically, and documented as such. The requirement that individuals under age 18 have two documented unsuccessful attempts at short term withdrawal management (“detoxification”) or drug free treatment is also amended to allow consent of a parent, legal guardian, or responsible adult. Further to this, the rule requiring a 1-year history of OUD for people recently released from penal institutions, pregnant patients or previously enrolled individuals has been removed.

Throughout the document, “detoxification” and the corresponding definition and standards for short-and long-term detoxification treatment have been removed. “Withdrawal management” and terms for tapering from MOUD are added on behalf of individuals who seek this approach or who elect or need to reduce and/or discontinue MOUD.

The “Required services” paragraph is revised to incorporate patient-centered language, establish flexible terminology, promote use of clinical judgment, and clarify SAMHSA's expectations of OTPs. The proposed rule creates the requirement that services be available that meet patient needs, and “shared decision making” is added as the method to be used in developing care plans.

The paragraph describing the initial medical examination has been amended to clarify the terms “screening” medical exam and “comprehensive examination”, while also expanding the qualifications of practitioners able to complete such examinations. These include practitioners outside of the OTP (with limitations and specific instructions). The proposed rule also creates criteria for lab testing conducted prior to a screening medical exam, as well as a permissible timeframe. The use of telehealth in undertaking the screening medical exam and initiation of MOUD has also been addressed in the proposed rule. Additionally, the paragraph on special services for pregnant people is amended to specify that confirmation of pregnancy is required for priority treatment admissions. The option to use split dosing for patients is also added.

The components of initial and periodic medical examinations have been expanded in the proposed rule to incorporate assessment of behavioral health, risk of self-harm or harm to others, and to specify time frames for completion of the care plan. Areas of psychosocial assessment are amended so as to assure information is gathered on the context of the patient's whole life such as their mental health, housing, recovery support and harm reduction resources. Additionally, patient-centered language has been added, such as “services a patient needs and wishes to pursue”.

The proposed rule expands the definition of `counseling services' to include psychoeducational services, harm reduction and recovery-oriented services, and counseling and linkage to treatment for anyone with positive test results on human immunodeficiency virus (HIV), viral hepatitis, and other sexually transmitted infection (STI) panels, or from OTP-provided medical examinations. Language about services that must be provided directly or through referral is revised to promote a patient-centered approach to care that does not make medication continuity contingent upon involvement in counseling services but fosters shared decision-making for all care plans.

The requirement that an OTP have a formal documented agreement with outside agencies is amended to remove the word “formal”; the proposed rule calls for a “documented agreement” to provide such services.

Language that addresses drug testing services has been amended to remove stigmatizing phrases, such as “drug abuse”, and to remove content on short-term withdrawal management (“detoxification”). Further to this, the requirement to use drug tests that have received the FDA's marketing authorization was added.

Rules that address recordkeeping and efforts to avoid simultaneous enrollment in multiple OTPs are amended to be more declarative, such as changing the word “review” to “determine” whether or not a patient is enrolled in another OTP, and documenting review efforts in the patient's record to demonstrate the good faith efforts made. The proposed rule also expands the circumstances in which a patient may obtain treatment at another OTP to include instances when there is an inability to access care at the OTP of record.

Specification of disciplines authorized to administer or dispense MOUD is removed from the rule. LAAM, also known as Levacetylmethadol, is removed from the list of treatment medications because it is no longer available, and other medications approved since prior revisions to this rule were added. The regulation of an initial dose of methadone remains at 30mg, not to exceed 40mg on the first day, with the incorporation of a provision for higher doses if clinically indicated and documented in the patient's record. The rule to ensure documentation of any significant deviation from FDA-approved labeling has been maintained in the proposed rule, while redundant language was removed.

Rules on the provision of unsupervised (or take home) doses of methadone are substantially amended to incorporate flexibilities issued in response to the COVID-19 pandemic. Stigmatizing language is removed, and the criteria for decision-making is reframed to promote use of clinical judgement and patient-centered care. In general, the revised criteria allow up to 7 days of take home doses during the first 14 days of treatment, up to 14 take home doses from 15 days of treatment and up to 28 take home doses from 31 days in treatment. The requirement that OTPs maintain procedures to protect take homes from theft and diversion was continued, and patient education on safe transport and storage of take home doses is added, including documentation of the provision of this education in the patient's clinical record.

Consistent with the conditions for approval of interim treatment, the proposed rule extends the potential duration of interim treatment from 120 days to 180 days. It also clarifies the circumstances in which interim treatment may apply and maintains priority access to comprehensive services for pregnant individuals. The proposed rule removes the requirement for observation of all daily doses during interim treatment. It clarifies the expectation that crisis services and information pertaining to locally available, community-based resources for ancillary services be made available to individual patients in interim treatment. A requirement of a plan for continuing treatment beyond 180 days of interim services was added to the proposed rule.

9. Section 8.13—Revocation of Accreditation and Accreditation Body Approval.

Changes in this section were limited to referring to an OTP as a “program” instead of a “facility”.

10. Section 8.14—Suspension or Revocation of Certification.

This section refines steps SAMHSA may take when immediate action is necessary to protect public health or safety.

11. Subpart D—Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body.

Language referencing “treatment program” in this section was changed to “OTP” for document consistency.

12. Subpart F—Authorization To Increase Patient Limit to 275 Patients.

This subpart has been amended to change the format from the prior Question-and-Answer style to a standard format.

13. Section 8.610—Practitioner Eligibility Requirements for a 3-Year 275-Patient Limit.

Modernized language to refer to MOUD and to remove stigmatizing language that referred to `legitimate medications'. The proposed rule also clarified that the 275-patient waiver is limited to three years in duration, requiring renewal.

14. Section 8.635—What are the reporting requirements for practitioners whose 275 request for patient limit is approved?

The proposed rule removes reporting requirements for practitioners approved to treat up to 275 patients, eliminating § 8.635 in its entirety.

Background and Need for Proposed Rule

As of June 2022 there are over 1,920 OTPs in the United States, providing care to over 650,000 patients. These are the only settings within which methadone, a schedule II opioid receptor agonist, can be legally provided to people with OUD outside the context of hospital admission or certain other special circumstances.

An OTP is an accredited treatment program with SAMHSA certification and Drug Enforcement Administration (DEA) registration to administer and dispense opioid agonist medications that are approved by FDA to treat OUD. Currently, these include methadone and buprenorphine, a schedule III partial opioid receptor agonist. Other pharmacotherapies, such as naltrexone, may be provided but are not subject to regulations under part 8. For purposes of certification, OTPs must also provide adequate medical, counseling, vocational, educational, and other assessment and treatment services either onsite or by referral to an outside agency or practitioner. Buprenorphine can also be dispensed (including by prescribing) to treat OUD by eligible practitioners with a waiver under 21 U.S.C. 823(g)(2) in settings outside of OTPs given its different scheduling and treatment under the Controlled Substances Act.

Practitioners treating OUD and the OTPs in which they practice must continuously adapt to evolving patterns of drug misuse. Over the past 40 years, this has been complicated by rapid changes in prescribing practices, supply chains and patterns of drug use. Indeed, the early opioid epidemic of the 1990s was characterized by an increased supply of prescription opioids. By 2010, however, the U.S. began to see rapid increases in overdose deaths involving heroin and then by 2013, synthetic opioids other than methadone—primarily illicitly manufactured fentanyl—contributed to a further rise in overdose-related deaths.

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), a predicted 107,375 Americans died from a drug overdose in the 12-month period ending in January 2022. 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. Overdose deaths involving cocaine also increased by 22 percent from 2019 to 2020. These deaths are likely linked to co-use or mixing (by illicit producers) of cocaine with illicitly manufactured fentanyl or heroin. 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, and promote engagement in OTP services, while also maintaining oversight and accreditation activities. Oversight and accreditation standards are supported as a means of promoting evidence-based care, while minimizing diversion and also adverse patient outcomes.

A. Regulatory Background

On January 17, 2001 (66 FR 4075), the Department issued final regulations for the use of opioid agonist medications (referred to as narcotic drugs) in treatment and withdrawal management (referred to as detoxification) of OUD. The final rule repealed the treatment regulations enforced by the FDA, and created a new regulatory system based on an accreditation model. In addition, the final rule shifted administrative responsibility and oversight from the FDA to SAMHSA. This rulemaking initiative followed a study by the Institute of Medicine (IOM) (now known as the National Academy of Medicine) and reflected recommendations by the IOM and several other entities to improve the treatment of OUD by allowing for increased medical judgment in the care of patients with OUD. Since publication of the final rule in 2001, it has been updated to include new medications, such as buprenorphine, while also updating or adding new rules governing the provision of such medications.

Between 1972 and 2001, Federal regulatory oversight of OTPs was enforced by the FDA before responsibility for oversight was transferred to SAMHSA. Periodic reviews, studies, and reports on the Federal oversight system culminated with the 1995 IOM Report entitled Federal Regulation of Methadone Treatment. The IOM report recommended that the FDA process-oriented regulations should be reduced in scope to allow more clinical judgment in treatment and greater reliance on guidelines. The IOM report also recommended designing a single inspection format, having multiple elements, that would (1) provide for consolidated, comprehensive inspections conducted by one agency (under a delegation of Federal authority, if necessary), which serves all agencies (Federal, State, local) and (2) improve the efficiency of the provision of methadone services by reducing the number of inspections and consolidating their purposes.

To address these recommendations, SAMHSA proposed a “certification” system based on accreditation. Under the system, an applicant who intended to dispense opioid agonist medications in the treatment of OUD must first obtain from SAMHSA, a certification that the applicant is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification depended upon the applicant obtaining accreditation from a private nonprofit entity, or from a State agency, that had been approved by SAMHSA to accredit OTPs.

Accreditation bodies were directed to base accreditation decisions on a review of an application for accreditation and on surveys (onsite inspections) conducted every three years by OUD treatment experts. In addition, accreditation bodies must apply specific opioid treatment accreditation elements that reflect “state-of-the-art” opioid treatment guidelines. Further to this, accreditation standards required that OTPs have quality assurance systems that consider patient outcomes.

The 2001 final regulations replaced FDA `approval' of programs, with direct government inspection in accordance with more detailed process-oriented regulations. These process-oriented regulations continue to prescribe many aspects of oversight and treatment. To this end, subpart B of the regulation addresses accreditation and includes steps that accreditation bodies must follow to achieve approval to accredit OTPs. It also sets forth the accreditation bodies' responsibilities, including the use of accreditation elements during accreditation surveys. Subpart C describes the sequence and requirements for obtaining certification, and addresses how and when programs must apply for initial certification and renewal of their certification. Subpart D elucidates the procedures for review of the withdrawal of approval of the accreditation body or the suspension and proposed revocation of an OTP certification. Subpart F, added in 2016, describes criteria for increasing the patient limit for those meeting Federal requirements to prescribe buprenorphine to 275.

In 2001 there were close to 900 OTPs, but that number has grown to over 1900 by 2022. Over this period of time, the incidence of fentanyl misuse has increased, escalating with the onset of the COVID-19 public health emergency in early 2020. To protect the public's health and reduce the risk of COVID-19 infection among patients and providers, SAMHSA issued flexibilities in the provision of unsupervised doses of methadone and also initiation of buprenorphine via telehealth, that allowed for continued treatment of OUD with reduced direct patient contact. Each of these flexibilities represented a significant change to treatment standards, and are discussed in detail below.

Flexibility for Methadone Medication Take Homes in Opioid Treatment Programs

Among the existing standards for medication administration and dispensing of methadone are limitations on unsupervised or “take home” use. These prior standards were established early in the history of methadone as a medication for OUD, and the criteria for determining whether a patient may be allowed take homes were restrictive, requiring daily visits to the OTP for extended periods of time, and adherence to strict measures of sustained stability as described in 42 CFR part 8. These criteria can pose disruption to employment and daily activities for patients, and several of the criteria reflect outdated biases that promote stigma and discourage people from engaging in care in OTPs.

In March 2020, as a result of the pandemic, SAMHSA issued exemptions that allowed state regulatory authorities to request blanket exceptions to allow patients to take home more doses of methadone; 43 states and the District of Columbia did so. With this flexibility, SAMHSA allowed OTPs to dispense 28 days of “take home” methadone doses to “stable” patients for the treatment of OUD, and up to 14 doses of “take home” methadone for “less stable” patients “who the OTP believes can safely handle this level of take home medication.” Although the duration of this flexibility was not initially specified, a SAMHSA FAQ published in April 2020, indicated that the flexibility was tied with the duration of “the current national health emergency . . . .”

The intention of the methadone take home flexibility was to reduce the risk of COVID-19 infection among patients and providers. Beyond this, the flexibility promotes individualized care that considers patient characteristics and program involvement beyond time in treatment. By reducing the burden on patients to visit the OTP daily, this flexibility could reduce stigma for those seeking treatment, while also providing more equitable access to care as telemedicine in OTPs is expanded. It also allows those who reside far from an OTP or who lack access to reliable transportation to receive treatment, while also being able to gain or maintain employment, care for loved ones and engage in other required activities of daily living.

The methadone take home flexibility has been met with widespread support among patients, OTPs, and state authorities. 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. 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. Additionally, a recent survey found that diversion of methadone is low among patients receiving take home doses under the COVID-19 PHE flexibility. Further to this, analysis of data on fatal overdoses from January 2019 to August 2021 demonstrated that this flexibility did not lead to more deaths involving methadone.

Recognizing the importance of this flexibility, SAMHSA released guidance on November 18, 2021, that extended the methadone take home flexibility for one year past the end of COVID PHE. This was to accommodate the rule making process that proposes to make this flexibility permanent. In this proposed rule, SAMHSA has reviewed and updated criteria used to determine eligibility for take home doses of methadone, while also promoting shared decision making that is supported by availability of unsupervised doses of methadone from entry into treatment. Individuals receiving take home doses of methadone are supported through individually tailored telehealth visits to practitioners, counselors and other services as indicated. Further to this, the proposed changes highlight practitioner autonomy in determining eligibility for unsupervised doses of methadone. This is a significant change to treatment standards, but it is grounded in evidence that demonstrates the safety and efficacy of promoting patient and provider autonomy.

The Opioid Treatment Program Flexibility To Prescribe MOUD via Telehealth Without an Initial In-Person Physical Evaluation

Telehealth is a mode of service delivery that has been used in clinical settings for over 60 years and empirically studied for just over 20 years. Between 2016 and 2019, use of telehealth, in general, doubled from 14 to 28 percent, while substance use disorder (SUD) treatment, offered through telehealth over the same period, increased from 13.5 to 17.4 percent. This trend has rapidly increased between 2019 and 2021, due to the COVID-19 pandemic.

The pandemic spurred use of telemedicine for the treatment of OUD using buprenorphine, a schedule III partial opioid receptor agonist. Prior to buprenorphine's development, the only opioid agonist that could be used to treat OUD was methadone dispensed through OTPs. Methadone has a relatively complicated pharmacological profile, necessitating closer observation of new patients to ensure that initial doses do not exceed an individual's tolerance for the medication. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed practitioners to treat OUD outside of OTPs using buprenorphine, generally with an initial in-person medical evaluation before prescribing.

On March 16, 2020, the Secretary of HHS, with the concurrence of the Acting DEA Administrator, designated that the telemedicine exception under 21 U.S.C. 802(54)(D), applied to all schedule II-V controlled substances. Accordingly, DEA-registered, DATA-Waived practitioners may issue buprenorphine prescriptions through telemedicine to new patients for whom they have not conducted an in-person medical evaluation, provided certain conditions are met during the COVID-19 public health emergency.

On March 25, 2020, the DEA also granted a “temporary exception” to its regulations that allows practitioners to prescribe controlled medications in states in which they are not registered, if the practitioner is registered with the DEA in at least one state and is authorized by both the state where the practitioner is registered with DEA and the state where the dispensing occurs. According to the DEA, practitioners may utilize this temporary exception via in-person prescribing or prescribing via telemedicine. The DEA also specified that this exception is granted through “the duration of the COVID-19 public health emergency as declared by the Secretary of Health and Human Services.”

Building upon this, SAMHSA implemented OTP regulatory flexibilities designed to help address the impact of the COVID-19 pandemic on OTPs and their patients. In April 2020, SAMHSA exempted OTPs from the requirement to perform an in-person physical evaluation (under 42 CFR 8.12(f)(2)) for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth. The duration of this exemption was specifically tied with the “period of the national emergency declared in response to the COVID-19 pandemic”, and the exemption did not include induction of methadone via telehealth technology.

Recent research has demonstrated that telehealth can be an effective tool in integrating care and extending the reach of specialty providers, and that among those requiring treatment with buprenorphine, there are high levels of satisfaction with the use of telehealth services. Additionally, there are no significant differences between telehealth and in-person buprenorphine induction in the rate of continued substance use, retention in treatment or engagement in services. Research also shows that there is no significant difference in client and provider ratings of therapeutic alliance when using telehealth technology platforms.³⁹

In the face of an escalating overdose crisis and an increasing need to reach remote and underserved communities, making the buprenorphine telehealth flexibility permanent is of paramount importance. The proposed rule makes permanent criteria of initiation of buprenorphine via audio-only or audio-visual telehealth technology if an OTP physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth.

SAMHSA believes that evidence underlying the initiation of buprenorphine using telehealth translates, to some degree, to the treatment of OUD with methadone, and warrants expanding access to methadone therapy by applying some of the buprenorphine in-person examination flexibilities to treatment with methadone in OTPs. The proposed rule allows for the use of audio-visual telehealth for any new patient who will be treated by the OTP with methadone if a program physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via an audio-visual telehealth platform. SAMHSA is not extending this change to the use of audio-only telehealth platforms in assessing new patients who will be treated with methadone because methadone, in comparison to buprenorphine, holds a higher risk profile for sedation in patients presenting with mild somnolence which may be easier to identify through an audio-visual telehealth platform. The proposed rule is not applicable to, and does not authorize, the prescription of methadone pursuant to a telehealth visit. Instead, this proposed change applies to the ordering of methadone by appropriately licensed OTP practitioners and dispensed to the individual patient by the OTP under existing OTP procedures.

Further to this, health care providers who receive Federal financial assistance are reminded of their obligations to ensure that their audio-only and audio-visual telehealth platforms are accessible to individuals with disabilities and afford an opportunity for meaningful access for limited English proficient (LEP) individuals. Federal civil rights laws prohibit discrimination on the basis of disability and may require health care providers to make reasonable modifications to their policies, practices, or procedures to ensure that a person who is not able to use an audio-visual telehealth platforms on the basis of their disability has an equal opportunity to benefit from treatment with MOUD. Similarly, Federal civil rights laws that prohibit discrimination on the basis of national origin (including language ability), require recipients to take reasonable steps to provide meaningful access to LEP individuals, which may require the provision of a qualified interpreter and/or translated material, such that they have the opportunity benefit from treatment with MOUD.

Expanding Access to Services

On June 28, 2021, the DEA introduced requirements for OTPs to add a “mobile component” to their existing registration and waived any obligation for an OTP mobile medication unit complying with these requirements to separately register at the remote locations where it dispenses. On September 21, 2021, SAMHSA released guidance on the establishment of mobile and non-mobile medication units and allowable services. While part 8 currently allows OTPs certified by SAMHSA to establish medication units (as defined under 42 CFR 8.2), the proposed rule further defines mobile units and clarifies potential services, interventions and accreditation processes.

Additionally, the proposed rule defines harm reduction and promotes expansion of harm reduction services to OTP patients. The importance of this has been highlighted during the COVID-19 pandemic, principally with the CDC and SAMHSA's April 7, 2021, joint announcement that Federal funding could be used to purchase rapid fentanyl test strips (FTS). This was proposed in an effort to help curb the dramatic spike in drug overdose deaths largely driven by the use (both intentional and unintentional) of potent synthetic opioids, primarily illicitly manufactured fentanyl. FTS can be used to determine if drugs have been mixed or cut with fentanyl, providing people who use drugs and their communities with important information about fentanyl in the illicit drug supply so they can take steps to reduce their risk of overdose. Other important harm reduction activities highlighted in the proposed rule include: counseling on preventing exposure to, and the transmission of, HIV, viral hepatitis, and STIs; providing access to services and treatments for those with HIV, viral hepatitis or an STI; provision of patient-centered harm reduction education; and distribution of opioid overdose reversal medications ( e.g., naloxone).

The need to facilitate access to services has been highlighted during the COVID-19 pandemic. This is particularly important in the face of increased exposure to fentanyl. Section 8.12(e)(1) of the proposed rule eliminates the requirement that a person must have had an addiction to opioids for one year before admission to treatment and receipt of OTP services, and permits access to those: who meet diagnostic criteria for a moderate to severe OUD; individuals with active moderate to severe OUD, or OUD in remission; or those individuals who are at high risk for overdose or recurrence of use. Admission to the OTP is contingent upon appropriate informed consent and education, as well as appropriate documentation of consent in the patient's clinical record.

These activities are supported, in the proposed rule, through defining a practitioner (in § 8.2) as being “a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife who is appropriately licensed by a State to prescribe covered medications and who possesses a waiver under 21 U.S.C. 823(g)(2).” Further to this, the proposed rule expands decision making capacity of OTP practitioners to: admission of patients; the provision of treatment activities; and service provision. This is supported by the use of telehealth, described above, and involvement of outside practitioners. Indeed, § 8.12(f)(2) of the proposed rule allows for the initial medical examination to be completed by a practitioner external to the OTP no more than seven days prior to admission, provided that it is verified by an OTP practitioner. This expands access to OTP services and is consistent with current medical practice.

In this way, the proposed rule draws on evidence from the COVID-19 pandemic as well as over 20 years of practice-based research. The proposed rule makes permanent or expands upon flexibilities initiated during the COVID-19 PHE and recognizes the efficacy and safety of creating a less restrictive and patient-centered treatment environment. Further to this, the evidence demonstrates the positive impact of not requiring frequent patient visits to the OTP. This has been shown to promote recovery behaviors, such as sustained employment, as well as support those individuals who live a long distance from the OTP. The integration of telehealth into the proposed rule further supports this and allows OTPs flexibility in initiating MOUD.

Section-by-Section Description of Proposed Amendments to 42 CFR Part 8

Below, the Department describes the proposals in this NPRM to amend 42 CFR part 8. The Department believes that the proposed rule expands access to evidence-based and patient-centered care, limits use of stigmatizing language, and promotes the practitioner-patient relationship. These changes are in line with evidence-based practice, and the Department welcomes feedback on all aspects of the proposed rule.

In particular, the Department is interested in feedback on the proposal to increase the allowable time for interim treatment from 120 days to 180 days. This is intended to accommodate OTPs and states as they address important issues such as staff shortages. It may also serve as a way of engaging individuals in care. Such issues underlie the need for this service approach, and while SAMHSA is working with other Federal and State agencies to build workforce capacity, the use of interim treatment adds to the care continuum for people with OUD.

The Department also seeks feedback on other paradigms of care promoted in the proposed rule. Split-dosing and delivery of services via telehealth are, for example, evidence-based interventions that promote patient-centered care. The Department proposes to expand access to evidence-based treatment through the addition of such practices, and seeks guidance on the proposed use of these interventions and their integration into the practice environment.

Also proposed are new criteria to support decision making around take home doses of methadone. The take home flexibility issued at the start of the COVID-19 pandemic demonstrated that length of time in treatment, as well as strict negative toxicology test results were not central to positive outcomes.⁵⁸ This is reflected in the proposed rule, and feedback is solicited on the proposed criteria, as well as the schedule for providing unsupervised doses of methadone.

The Department further requests comment on all proposals described in the following paragraphs of this NPRM. In addition, the Department requests comment on all aspects of the Regulatory Impact Analysis, including the assumptions and estimates about the costs and benefits of the proposed changes, and the alternatives the Department considered when developing the proposals in this NPRM.

The Department proposes the following amendments to part 8:

A. Heading

The Department proposes to revise the heading to Medications for the Treatment of Opioid Use Disorder to reflect current medical terminology and to remove stigmatizing language. The term `opioid use disorder' more precisely reflects the diagnosis for which medications are indicated. Further to this, the terms `maintenance' and `detoxification' reference outdated terminology that has potentially hindered adoption of evidence-based treatments for OUD. The amended heading reflects current medical terminology and highlights that OUD is a chronic, treatable condition.

B. Subpart A

Subpart A currently addresses accreditation and includes steps that accreditation bodies will follow to achieve approval to accredit OTPs under the new rules. It also sets forth the accreditation bodies' responsibilities, including the use of accreditation elements during accreditation surveys. In the proposed rule, these specifications are relocated to subpart B, which still includes Certification of Opioid Treatment Programs. In this way, subpart A is now limited to the overview of part 8 and definitions. This improves categorization and provides clear flow within the proposed rule.

C. Section 8.1—Scope

This section has been revised to reflect modern medical terminology and to detail updated acronyms. Historically, pharmacological treatment for opioid use disorder was referred to as “medication assisted treatment” (MAT). There is an increasing movement towards the more medically accurate term “medication for opioid use disorder” (MOUD) since this precisely describes the medications that are being provided, carries less stigma, and aligns with treatment approaches to all other health conditions. Further to this, the term `MAT' implies that these medications are simply adjuncts to a broader treatment strategy. In fact, these medications are one critical element of a comprehensive, long-term treatment and recovery strategy.⁶⁰ As such, the acronym MAT has been removed from the proposed rule and replaced with MOUD throughout. The proposed rule identifies other treatment modalities, such as counseling, by their individual component names, similar to the manner by which elements of other chronic disease care are described.

D. Section 8.2—Definitions

In the 21 years since part 8 was first published, definitions and paradigms of care for OUD have changed. In particular, treatment for OUD has evolved from being prescriptive to multimodal and patient-centered. This reflects an understanding that OUD is a chronic condition and that to be successful, treatment interventions should be individualized and include harm reduction and recovery support services. Further to this, flexibilities expanded under the COVID-19 PHE demonstrated the safety of telehealth interventions. Accordingly, telehealth is defined in this section using a standard definition. The proposed rule updates other definitions to reflect current evidence and practice in the provision of care in OTPs. This is seen in an expanded definition of `practitioner'. Patients have benefitted for years from the care provided by nurse practitioners (NPs) and physician assistants (PAs) in OTPs, and the proposed rule expands the definition of practitioner to include a “physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.” Finally, the proposed rule removes the term “detoxification treatment” and replaces it with “withdrawal management.” The term detoxification is customarily called medically supervised withdrawal management to destigmatize the process and more accurately reflect what patients undergo, and healthcare practitioners provide, in response to withdrawal from a variety of substances or medications to which physiologic tolerance develops.

E. Section 8.3—Application for Approval as an Accreditation Body

This section adds details of policies and procedures expected of accreditation bodies for clarity and completeness. In § 8.3(b) the email address for submission of accreditation body applications is updated. Changes to § 8.3(b)(6) reflect the expectation that physicians with experience in managing MOUD are employed by accreditation bodies to assure appropriate medical standards of care are established and included in review of OTPs. Further amendments are incorporated to promote communication between the accreditation bodies and SAMHSA, and to ensure that accreditation bodies focus on OTP adherence to 42 CFR part 8. Expectations about training provided for survey team members are added to promote consistency in OTP reviews with Federal standards and to reduce the risk of unnecessary and overly burdensome accreditation activities. Further to this, the proposed rule also provides for Indian Tribes to apply for approval as an accreditation body.

F. Section 8.4—Accreditation Body Responsibilities

SAMHSA is responsible for oversight of the accreditation bodies. A thorough review of its oversight procedures resulted in several proposed changes to improve processes, to assure documentation of accreditation decisions, and to establish steps to be taken to assure OTP adherence to 42 CFR part 8. For example, making records available to SAMHSA on request is added to assure that SAMHSA can review survey processes and information, and confirm decisions of survey outcomes. Other amendments, such as accreditation body policies for training survey team members, have been added to address concerns regarding inconsistent application of accreditation standards and regulations. The documentation and sharing of information regarding conflict or perceived conflict of interest has been added to ensure any conflict of interest and action taken by the accreditation body is disclosed to SAMHSA.

G. Section 8.11—Opioid Treatment Program Certification

The requirements for certification and renewal have been in place since 2001. Therefore, it is necessary to update these as some certifications and processes no longer apply. For example, “transitional certification” expired as a category in May 2003. Other revisions have been incorporated based on SAMHSA's 20-years of experience in OTP certification.

The category of “provisional” certification required clarification as to when provisional certification is available. Moreover, the current rule only designates three-year certifications for OTPs, whether the accreditation survey resulted in a “full” (3-year) or “conditional” 1-year accreditation status. The proposed rule establishes the category of “conditional certification” to allow an OTP granted a temporary one-year accreditation to continue treatment services while the OTP takes steps to address issues identified during the accreditation process. The current regulation limits extension of certification status to OTPs with provisional certification only. Circumstances related to the COVID-19 PHE necessitated expansion of extensions for renewal of any category of certification.

The expectation that OTPs comply with HIPAA regulations when applicable is added to emphasize rules that govern practice that have come into effect since 2001. Documentation of change of sponsors or medical directors is added to assure written records are available, and a reference to the applicable chapter of the Controlled Substances Act for OTPs was added to clarify the DEA regulations to which OTPs must adhere.

Interim treatment means that on a temporary basis, a patient may receive services from an OTP, while awaiting access to more comprehensive treatment services. The extension of interim treatment approval from 120 days to 180 days is intended to better accommodate OTPs and states in addressing underlying causes necessitating this category of treatment, such as staff shortages. This approach may also serve to engage individuals with OUD who otherwise may not seek care. Given the significant mortality risk of illicit fentanyl and data demonstrating reductions in overdose death with methadone treatment, interim services add an opportunity for low-threshold access to life-saving services. The expectation that individuals enrolled in interim treatment shall not be discharged without the approval of an OTP practitioner is to assure continuity of and engagement in care for the individual as an interim step to a comprehensive treatment program where additional services are available. The reference to section 1923 of the Public Health Service Act (PHSA) (42 U.S.C. 300x-23) is removed because it does not specifically pertain to time in interim treatment. The proposed rule also changes the need to seek approval from the `chief public health officer of the state in which the OTP operates' to the State Opioid Treatment Authority (SOTA) of the state in which the OTP operates. This change was made to streamline and centralize the application process.

An overall goal of these revisions is to expand access to MOUD, specifically to OTP services. Accordingly, the range of services that can be provided in medication units has been clarified to improve access to the services OTPs offer, especially in geographic areas in which distances are a key barrier to accessing treatment.

H. Section 8.12—Federal Opioid Use Disorder Treatment Standards

OTP regulations currently do not reflect the changes in OUD treatment standards that have occurred over the past 20 years. The dual challenges of the COVID-19 pandemic and the evolving opioid overdose epidemic necessitated review and revision of these regulations. Significant lessons have been learned from adapting treatment in response to the need for physical distancing and quarantine, and from the results of implementing flexibilities for take home doses and use of telehealth under the COVID-19 PHE.

Overcoming the opioid crisis through the expansion of prevention, treatment, and recovery support services is a primary priority for SAMHSA, and SAMHSA seeks to expand access to quality treatment services, encourage the use of MOUD, and improve engagement and retention in treatment and recovery support services. Consistent with that goal, amendments to treatment standards incorporated in this section are intended to improve access to care and improve patient satisfaction and engagement in services, while also promoting flexibility and medical judgment in decision-making to reduce the burden of patient participation in OTPs.

Changes to the “Required services” paragraph incorporate patient-centered language, and promote flexibility in the use of clinical judgment. For example, required services are amended to assure that OTPs meet patient needs, and “shared decision making” is added to ensure that the patient be included in the development and implementation of their care plan. In several instances, the intent of standards was not changed, but stigmatizing wording such as “legitimate treatment use” of controlled substances has been removed. These amendments are incorporated as a means of reducing the use of stigmatizing attitudes, practices and language within OTPs that may contribute to discrimination and impede access to treatment.

Other revisions in this section are included to ensure alignment with laws and regulations that have been issued since 2001 and to emphasize their importance to OTPs. These include HIPAA, the Comprehensive Addiction and Recovery Act (CARA), and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. Section 303 of CARA, for example, expanded the definition of “qualifying practitioners” from physicians to include nurse practitioners and physician assistants who meet certain criteria; this change has been included in the section on staff credentials and is in alignment with the professionalization of SUD treatment services that has occurred over the last 20 years.

A significant change in OTP access is the removal of the requirement that patients must have had an addiction to opioids for at least one year prior to admission for MOUD; this is a vestige of prior versions of the DSM and has posed a barrier to access to treatment. OUD includes signs and symptoms that are associated with compulsive, prolonged use of opioid substances for non-medical purposes, despite harm and negative consequences to the individual with OUD. Therefore, the assessment of OUD is refocused, in the proposed rule, to consideration of problematic patterns of opioid use that are in line with the current version of the DSM diagnostic categories. The proposed rules also recognize the potential for recurrence of OUD in individuals who have sustained remission and recovery and the high mortality risk associated with these situations. The revised definition allows for clinical judgment and consideration of severity of use and comorbid conditions. The new rules also remove the requirement that individuals under 18 must have two documented unsuccessful attempts at treatment within one year to be eligible for MOUD. Except where not required by state law, parental consent to treatment remains a requirement for patients under age 18. In recognition of the use of telehealth and the limitation of obtaining written consent, the requirement for a written form of consent to treatment was removed for adult patients.

Throughout the document, “detoxification” and the corresponding definition and standards for short- and long-term detoxification have been removed as the word “detoxification” is considered a pejorative term and not accurately reflective of the process of managing or experiencing the withdrawal associated with substances or medications to which physiologic tolerance develops. Detoxification is an outdated term that was used to distinguish opioid dependence from OUD based on the Narcotic Addiction Treatment Act of 1974 (NATA). Practice-based evidence and extensive research shows that treatment with MOUD is more effective than withdrawal management at reducing OUD recurrence and associated mortality and morbidity risk. However, it is recognized that some patients may choose, or need, to taper off MOUD. Therefore, “withdrawal management” and terms for tapering from MOUD are included in the section of the regulations that currently refer to “detoxification.”

Language used in the current rule about the initial medical examination required clarification to distinguish between an initial “screening” exam and a more comprehensive “examination.” For patients with OUD, initiating MOUD is of utmost importance to suppress withdrawal, engage the individual in additional services, and improve retention. The need to improve access to treatment necessitates expanding the qualifications of those practitioners able to complete screening examinations. The proposed rule allows practitioners who work outside of the OTP (with limitations and specific instructions) to undertake screening. This is likely to reduce delays in diagnosing OUD, initiating MOUD, and in beginning comprehensive treatment. This section also improves medical services by setting expectations for lab testing, establishing time frames for examinations, and incorporating use of telehealth. Special services for pregnant people have been revised to specify that confirmation of pregnancy is required for priority treatment admissions to prevent misuse of priority status. The option to use split dosing for patients was added to this section, as well.

Changes to the initial and periodic medical services sections are intended to promote key issues for OTP medical practitioners and the OTP multi-disciplinary team to address with a patient as part of treatment. This includes areas that may increase the risk of a patient leaving care prematurely, such as unmet mental health or other disability, medical and oral health needs, the need for culturally supportive care that addresses race, ethnicity, sexual orientation, religion or gender identity, and social determinants of health, such as housing and transportation, that may pose barriers to treatment engagement, or harm reduction and recovery support service needs. Patient-centered language was added to ensure that the care provided is consistent with the patient's needs, and self-identified goals for treatment and recovery. The time frames for completion of the care plan are included as a measure of quality. Also included is the requirement in § 8.12(f)(4)(i) that individuals starting treatment be screened for imminent risk of harm to self or others. This recognizes that risk for suicide is increased among individuals who misuse substances and that appropriate screening, intervention, and referrals for care are vital to health and engagement in treatment activities. ⁷¹

Counseling services have been more finely described to align OTP services with the current paradigm for evidence-based SUD treatment. This includes the delineation of psychoeducational services, overdose prevention and other harm reduction counseling, and recovery-oriented counseling services. Specific counseling on reducing HIV, hepatitis C, and other STIs, and linkage to treatment for anyone with positive test results from OTP-provided laboratory testing, was added to improve quality of care. Language about services that must be provided directly or through referral has also been revised to infuse a more patient-centered approach, such as in “identified and mutually agreed-upon as beneficial by the patient and program staff,” rather than the program staff determining that the patient is “in need of such services.”

Drug testing services have been revised to remove the stigmatizing language of “drug abuse,” to remove content on short-term withdrawal management (“detoxification”), and to improve readability. The requirement for use of drug tests that have received FDA's marketing authorization was added to assure valid assays are used.

The current regulations require OTPs to review whether a patient is enrolled in another OTP prior to admission. Simultaneous enrollment in multiple OTPs risks patients obtaining more medication than is needed. Good faith efforts to prevent this must be documented. Therefore, the language regarding verification of non-enrollment changed from “review” to “determine” in order to ensure that evidence of good faith efforts is available. This section also expands the circumstances in which a patient may obtain treatment at another OTP to include instances when there is an inability to access care at the OTP of record. Experiences of state and OTP responses to occurrence of natural disasters gave evidence of the need to incorporate this allowance on behalf of patients.

In § 8.12(h) (Medication administration, dispensing, and use), the specific disciplines authorized to administer or dispense MOUD have been removed to accommodate variations among states regarding disciplines allowed to provide this service. Among medications used by OTPs, LAAM has been removed as it has black box warnings and is no longer commercially available, while other medications approved since 2001 (naltrexone) were added. Although the maximum initial dose of methadone remains at 30 mg, use of clinical judgment in dose adjustments is underscored, due to higher opioid tolerance associated with increasing rates of fentanyl exposure and opioid overdose. Should 30 mg be insufficient to control symptoms of withdrawal, the program physician or practitioner may increase the dosage, provided that the rationale for this change is appropriately documented. The requirement that the program physician be familiar with the most up-to-date product labeling has been removed as § 8.12(d) requires that each person engaged in the treatment of OUD must have sufficient education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. This is inclusive of the expectation that all program medical practitioners maintain familiarity with the most up-to-date product labeling for the medications they administer and dispense to patients.

The exemption policies promulgated by SAMHSA in response to COVID-19 allowed OTPs to provide more take home doses of methadone to patients on a more rapid schedule than is permitted in the current regulations. In the two years since implementation, there have been few reports of overdose or harm related to take homes, misuse, or other negative consequences of this flexibility. Evidence from multiple studies has shown that increases in take home doses following the SAMHSA exemption did not lead to worse treatment outcomes, higher overdose rates, or diversion of medication, but instead resulted in increased treatment engagement and improved patient satisfaction with care. There are sufficient studies to conclude that this exemption has enhanced and encouraged use of and retention in OTP services; therefore, the proposed rule for unsupervised (take home) doses fully incorporates the flexibilities for take home medication issued during the COVID-19 PHE.

The proposed rule removes stigmatizing language in favor of person-centered approaches and person-first terminology. Changes focus on the well-being of the individual and reframe the criteria for unsupervised medication from rule-based to clinical judgment-based decisions. When determining take home medication schedules under the proposed rule, SAMHSA recommends that the best interest of each patient and the public's health be taken into consideration, and that clinical judgement, not rigid rules, determine if the therapeutic benefit of take home medication outweighs the risks to the patient and public health. The proposed rule is meant to address barriers to care associated with the requirement for regular clinic attendance while also improving patient satisfaction and treatment engagement in a manner that also balances patient and public health safety.

The conditions for interim treatment extend the potential duration of this approach from 120 days to 180 days. This is based on SAMHSA's experience and reports from states that the underlying issues which prompted interim treatment, such as staff shortages, are not easily resolved in 120 days. In addition, interim services may serve as a low-threshold approach to engaging individuals with OUD in care, particularly in areas where OTPs offering more comprehensive services are not as readily available. Clarification of language in this section also ensures that patients in interim treatment have documented plans for continuation of treatment beyond 180 days, and are not discharged based on length of time in interim care. The circumstances in which a patient could receive interim services required clarification from “cannot be placed in a public or nonprofit private program” to “if comprehensive services are not readily available.” Services to be provided in this category are revised to assure alignment of quality expectations for interim care between OTPs and SAMHSA.

On July 28, 2021, the DEA published a final rule that permits DEA registrants who are authorized to dispense methadone for OUD to add a “mobile component” to their existing registration—waiving any requirement that mobile medication units of OTPs operating in compliance with the rule separately register at their remote dispensing locations (86 FR 33861). This expanded opportunities for OTPs to provide needed services in remote or underserved areas. Through use of Substance Abuse Prevention and Treatment Block Grant (SABG) funds, SAMHSA encouraged OTPs to establish medication units as a means of making treatment more readily available, especially to those people in remote, rural, or underserved areas. To further the goal of improving and expanding access, the range of services that can be provided in medication units are described in the proposed rule. Such services must be delivered in accordance with the nondiscrimination provision at 42 U.S.C. 300x-57, which state that: “No person shall on the ground of sex (including, in the case of a woman, on the ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds made available under section 300x or 300x-21 of this title.”

I. Section 8.14—Suspension or Revocation of Certification

This section clarifies the actions that SAMHSA may take when immediate intervention is necessary to protect the public's health or safety. The proposed rule specifies the administrative actions available to SAMHSA in the event that a program sponsor, or any employee of an OTP has: been found guilty of misrepresentation in obtaining certification; failed to comply with the Federal Opioid Use Disorder treatment standards; failed to comply with reasonable requests from SAMHSA or from an accreditation body for records; or refused a reasonable request of a duly designated SAMHSA inspector, DEA Inspector, State Inspector, or accreditation body representative for permission to inspect the program or the program's operations or its records.

J. Subpart F—Authorization To Increase Patient Limit to 275 Patients

This subpart is amended to change the format from a Question-and-Answer style to a standard narrative text format. This is for consistency with the format found throughout the proposed rule.

K. Section 8.610—Practitioner Eligibility Requirements for a 3-Year 275-Patient Limit

This section clarifies the 3-year limit to the 275-patient limit.

L. Section 8.635—What are the reporting requirements for practitioners whose 275 request for patient limit is approved?

As of May 2022, there were 8,641 practitioners waivered at the 275-level and of these, 5,905 were Doctors of Medicine and Doctors of Osteopathic Medicine (MD/DOs). The proposed rule removes reporting requirements for practitioners at this level. Practitioners have found the submission of these reports to be burdensome and a disincentive to treating a higher number of patients. As increasing numbers of Americans lose their lives to overdose, it is essential to support practitioners and to remove perceived disincentives or barriers to treating more patients. In this way, the extent of the overdose crisis as a result of the COVID-19 PHE outweighs the potential value of data obtained from compliant reporters. The proposed rule removes reporting requirements for those who are authorized to treat up to 275 patients with buprenorphine. Rather than expect practitioners to submit reports, SAMHSA will seek to work in partnership with other Federal agencies for monitoring purposes.

Further to this, reporting requirements are known to perpetuate stigma towards MOUD and to potentially reduce prescribing of a life-saving medication. Negative attitudes and beliefs toward use of medications in treating OUD is common among healthcare professionals, members of law enforcement and others in justice settings, in the wider community, and even among persons with OUD themselves. Of primary care physicians in a national survey, just over three quarters (77.5%) perceived buprenorphine to be an effective treatment for OUD. Many treatment programs and support groups discourage participants from using medications, including MOUD. Young adults with OUD experience difficulties obtaining or remaining on buprenorphine as a result of stigma from healthcare providers, 12-step programs, residential treatment programs, and parents. Prejudice against MOUD even exists among specialist SUD treatment providers. One 2020 national survey of residential OUD treatment programs found that less than a third (29%) offered maintenance treatment with buprenorphine-naloxone; many programs actively discouraged the use of medication, which are the standard of care, revealing that there is a vast knowledge gap about MOUD among treatment providers.

Proposed changes to part 8 seek to reduce discriminatory attitudes and beliefs, and to incorporate evidence-based principles on practitioner autonomy, patient-centered decision making and individualized care plans. This is in line with the chronic disease model of care, and represents a departure from the prescriptive model of care currently in place. In this way, The Department seeks to support practitioners in providing evidence-based and compassionate care to patients while also engaging them in recovery. This is an essential means of reducing stigma among practitioners and community members, while also positively addressing a patient's internalized stigma.

Request for Comments

The Department requests public comment on all aspects of the proposed amendments to the regulations at 42 CFR part 8, Medications for the Treatment of Opioid Use Disorder. The Department welcomes public comment on any benefits or drawbacks of the proposed amendments set forth above in this proposed rule. Of particular interest are comments pertaining to: interim treatment; split dosing; telehealth; and take home doses of methadone.

Public Participation

The Department seeks comment on all issues raised by the proposed regulation, including any potential unintended adverse consequences. Because of the large number of public comments normally received on Federal Register documents, the Department is not able to acknowledge or respond to them individually. In developing the final rule, the Department will consider all comments that are received by the date and time specified in the DATES section of the Preamble.

Because mailed comments may be subject to delays due to security procedures, please allow sufficient time for mailed comments to be received by the deadline in the event of delivery delays. Any attachments submitted with electronic comments on www.regulations.gov should be in Microsoft Word or Portable Document Format (PDF). Please note that comments submitted by fax or email and those submitted after the comment period deadline will not be accepted.

Regulatory Impact Analysis

The Department has examined the impact of the proposed rule as required by Executive Order 12866 on Regulatory Planning and Review, 58 FR 51735 (October 4, 1993); Executive Order 13563 on Improving Regulation and Regulatory Review, 76 FR 3821 (January 21, 2011); Executive Order 13132 on Federalism, 64 FR 43255 (August 10, 1999); Executive Order 13175 on Consultation and Coordination with Indian Tribal Governments, 65 FR 67249 (November 9, 2000); Executive Order 13985 Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009 (January 25, 2021); the Congressional Review Act, Public Law 104-121, sec. 251, 110 Stat. 847 (March 29, 1996); the Unfunded Mandates Reform Act of 1995, Public Law 104-4, 109 Stat. 48 (March 22, 1995); the Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (September 19, 1980); Executive Order 13272 on Proper Consideration of Small Entities in Agency Rulemaking, 67 FR 53461 (August 16, 2002); the Assessment of Federal Regulations and Policies on Families, Public Law 105-277, sec. 654, 112 Stat. 2681 (October 21, 1998); and the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163 (May 22, 1995).

Statement of Need

This proposed rule is being issued to update part 8 in response to increasing opioid overdose deaths, exacerbated by the COVID-19 pandemic. Across the United States in 2020, 9.5 million people aged 12 or older misused heroin or prescription pain relievers. The percentage was highest among young adults aged 18 to 25 (4.1 percent or 1.4 million people), followed by adults aged 26 or older (3.4 percent or 7.5 million people). It was lowest among adolescents aged 12 to 17 (1.6 percent or 396,000 people).⁸⁸ These numbers likely underestimate the true prevalence of opioid misuse and OUD, since the use of illicitly manufactured fentanyl has not to date been considered in the National Survey on Drug Use and Health (NSDUH) survey, and populations likely to have high prevalence of opioid misuse and use disorder, such as individuals in the criminal justice system, other institutionalized settings, and individuals experiencing homelessness not living in shelters are not included in the NSDUH.

Further to this, there are important equity considerations evidenced by the data. A recent analysis by the Centers for Disease Control and Prevention (CDC) demonstrates high levels of overdose among Black, American Indian and Alaska Native communities over the course of the pandemic. This study showed that overdose death rates rose 44 percent in 2020 for Black people and 39 percent for American Indian and Alaska Native people, compared with 22 percent for white people.⁸⁹ Black youth ages 15 to 24 saw an 86 percent increase in overdose deaths, the largest spike of any age or race group, while Black men 65 and older were nearly seven times as likely than white men to die from an overdose.⁸⁹ It was also found that Black people were less than half as likely as white people to have received substance use treatment.

Research demonstrates that MOUD can reduce mortality from overdose by up to 59% (based on results of multivariable Cox proportional hazards models adjusted for age; sex; baseline anxiety diagnosis; depression diagnosis; receipt of methadone, buprenorphine, opioid, and benzodiazepine prescriptions in the 12 months before index nonfatal opioid overdose; and time-varying receipt of opioid prescriptions, benzodiazepine prescriptions, withdrawal management episode, and short- and long-term residential treatments ), yet few people who may benefit from these medications have immediate and sustained access to them.

The pattern of enrollment in programs providing methadone was established in the latter part of the 20th century. Research reveals that the rate of methadone treatment at that time was highest in low income urban areas. These patterns have remained relatively unchanged since the expansion of access to buprenorphine in 2002. Research demonstrates that there are extensive ‘treatment deserts’ where there is little to no physical access to OTPs, especially in rural areas. SAMHSA believes that proposed changes to part 8 will, as described above, facilitate:

• Enhanced access to medications for opioid use disorder, such as through take home doses of methadone and extending interim treatment to 180 days;
• Changes to ensure updated language and terminology;
• Clarification of standards applying to accreditation bodies;
• Revising Federal Opioid Use Disorder Treatment Standards; and
• Removing reporting requirements for practitioners approved to treat up to 275 patients.

SAMHSA notes below that these changes are associated with limited burden as the proposed rule does not substantially alter reporting or accreditation activities. The changes proposed will support SAMHSA in its role of overseeing accrediting bodies and OTPs, modernizing language and expectations in response to current challenges and anticipated future trends. SAMHSA invites comments on the assumptions of costs and benefits identified below, including citations to any publicly available studies or reports that could elucidate and improve this analysis.

A. Executive Orders 12866 and 13563 and Related Executive Orders on Regulatory Review

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to, and reaffirms the principles, structures, and definitions governing regulatory review as established in, Executive Order 12866.

This proposed rule is partially regulatory and partially deregulatory. The Department estimates that because much of what is being proposed does not substantially alter current practice as implemented over the past 2 years under the COVID PHE, the proposed rule will not result in significantly altered costs. Further to this, the proposed rule creates efficiencies in service delivery and in administration. These include strengthening the patient-practitioner relationship in a manner that promotes efficient, evidence-based and patient-centered care, updating accreditation procedures and providing a stable regulatory environment. Additionally, the proposed rule makes permanent some OTP treatment flexibilities implemented within the past two years.

B. Executive Order 13985 Advancing Racial Equity and Support for Underserved Communities Through the Federal Government

A recent analysis by the Centers for Disease Control and Prevention (CDC) demonstrates high levels of overdose among Black, American Indian and Alaska Native communities over the course of the pandemic. While these trends existed long before the COVID-19 PHE, this study highlights that overdose death rates rose 44 percent in 2020 for Black people and 39 percent for American Indian and Alaska Native people, compared with 22 percent for white people.⁹⁵ Black youth ages 15 to 24 saw an 86 percent increase in overdose deaths, the largest spike of any age or race group, while Black men 65 and older were nearly seven times as likely than white men to die from an overdose.⁹⁵ It was also found that Black people were less than half as likely as white people to have received substance use treatment.

This disparity amplifies the importance of promoting person-centered care that is culturally appropriate and responsive to patient need, while also fostering a treatment environment that promotes and sustains patient engagement. The proposed changes facilitate the practitioner-patient relationship in a manner that espouses these principles, while also expanding the reach of OTPs (through activities such as mobile medication units) to physically engage communities that are in need of intervention. Further to this, the proposed changes promote examination of a patient's cultural needs as they engage in treatment services. This is consistent with evidence-based and culturally responsive paradigms of care.

The proposed changes also facilitate patient engagement through removing, at the practitioner's discretion, the requirement to attend an OTP each day. Indeed, the ability to provide unsupervised doses of methadone early in treatment allows those with unstable access to transportation, for example, to focus on recovery activities in their own community. Evidence from the past two years demonstrates safety, as well as high patient and practitioner satisfaction with take-home doses of methadone. This is principally because unsupervised doses of methadone allow individuals the opportunity to engage in employment or other activities that are supportive of recovery and longer term community involvement.

1. Cost-Benefit Analysis

a. Overview

The U.S. estimated economic cost of opioid use disorder ($471 billion) and fatal opioid overdose ($550 billion), prior to the pandemic, totaled $1,021 billion. Among the 39 jurisdictions reviewed in this analysis, combined costs of opioid use disorder and fatal opioid overdose varied from $985 million in Wyoming to $72.6 billion in Ohio. Per capita combined costs varied from $1,204 in Hawaii to $7,247 in West Virginia. States with high per capita combined costs were located mainly in the Ohio Valley and New England. Across many studies, reduced quality of life is the largest component of the cost of opioid use disorder.

A recent study showed that in the absence of treatment, 42,717 overdoses (4,132 fatal, 38,585 nonfatal) and 12,660 deaths were estimated to occur in a cohort of 100,000 patients over 5 years. An estimated reduction in overdoses was associated with methadone treatment (10.7%), buprenorphine or naltrexone treatment (22.0%), and medication treatment combined with psychotherapeutic interventions (range, 21.0%-31.4%).⁹⁸ Estimated decreased deaths were associated with treatment with methadone (6%), buprenorphine or naltrexone (13.9%), and the combination of medications and psychotherapy (16.9%). When criminal justice costs were included, all forms of MOUD (with buprenorphine, methadone, and naltrexone) were associated with cost savings compared with no treatment, yielding savings of $25,000 to $105,000 in lifetime costs per person.

McAdam-Marx et al. reported in 2010 that Medicaid beneficiaries with opioid use disorder, physical dependence on opioids, or poisoning had nearly triple the total medical costs adjusted for baseline sample characteristics compared to beneficiaries matched by age, gender, and state with no opioid misuse diagnosis ($23,556 vs. $8436; P < 0.001). The opioid dependence/abuse group (using an older version of the Diagnostic and Statistical Manual of Mental Disorders) also had higher prevalence of comorbidities, such as psychiatric disorders, pain-related diagnoses, and other substance use conditions. While this study considered overall cost, it did not address medication costs in particular, or any impact treatment may have had on overall cost.

OTPs provide comprehensive interventions including medications, counseling and services designed to offer a whole-person approach to care and ameliorate social determinants of health that contribute to substance misuse. Numerous studies have demonstrated that treatment with pharmacotherapy and counseling services can reduce overall healthcare costs for patients with OUD. For example, a 2019 analysis demonstrated that a comprehensive approach to OUD treatment is associated with improved health and economic outcomes. This study assessed patients with OUD treated at a comprehensive primary care center (CCP) and other Maryland facilities in a large state Medicaid program, and demonstrated cost savings with a comprehensive approach to care. Compared to the non-CCP patient group (n = 867), the CCP group (n = 131) had a higher 6-month buprenorphine treatment retention rate (P < 0.001), fewer hospital stays in the 12-month follow-up period (P = 0.005), and lower total cost (US$10,942 vs. $13,097, P < 0.001) and hospital stay cost (US$1448 vs. $4265, P = 0.001).¹⁰³ Other measures, including emergency department utilization and cost, substance use-related cost, and non-buprenorphine pharmacy cost, were not statistically different between the 2 groups. Results suggested that patients, as well as the health care system, can benefit from a comprehensive model of care for OUD with better treatment retention, fewer hospital stays, and lower costs.

These findings are consistent with a 2016 cross sectional study that evaluated medical claims for Vermont Medicaid beneficiaries with opioid dependence or addiction between 2008 and 2013. In their analysis, Mohlman and colleagues determined that medication combined with psychosocial counseling is associated with reduced general health care expenditures and utilization, such as inpatient hospital admissions and outpatient emergency department visits, for Medicaid beneficiaries with opioid misuse. Two prior studies assessed data from commercial health insurance claims on the overall health care costs and utilization rates for those using MOUD compared to those treated without MOUD.^{101 105} The first study found that over a five-year period, members on MOUD had 50% lower total annual health plan costs than those who had two or more visits to an addiction treatment setting and no treatment, and 62% lower than those with zero or one visit for addiction treatment and no intervention. The other study found that after a six-month period, those on MOUD had significantly lower overall annual health plan costs compared to those with no medication ($10,192 vs. $14,353; p-value < 0.0001).¹⁰¹ The difference was driven largely by lower inpatient services and non-opioid-related outpatient services for the group receiving medication.

The regulatory impact analysis (RIA) outlined below, relies on data provided to SAMHSA by OTP accreditation bodies for the year 2020-2021. Pursuant to 42 CFR part 8, accreditation bodies and OTPs are required to submit information to SAMHSA's Center for Substance Abuse Treatment (CSAT). The annualized burden of information collection for OTPs and accreditation bodies under the rule is set forth in the tables that follow.

This proposed rule does not substantially alter reporting burden or accreditation activities. The total number of burden hours reported in 2020-2021 for accreditation body respondents was approximately 394.70 hours. The total number of burden hours for OTP respondents during the same period was 1,868.95 hours. The annual burden associated with this rule and the associated forms was estimated to be 2,263.65 hours.

This analysis quantifies a few limited categories of paperwork-related costs, but there are more substantive actions (with associated costs and benefits) that would be necessary in the chain of cause and effect between the rule's most direct effects and the health and mortality consequences that are implied, above, as being potentially large if this proposal is finalized. For instance, relative to the appropriate analytic baseline (the future in the absence of the rule), the proposed rule would facilitate the expansion of mobile methadone units via their inclusion in operations, and such expansion would entail both new use of resources (costs ) and then, contingent upon such costs being incurred, the types of benefits described above. As a further example, the accrual of health and overdose-mortality-avoidance benefits due to removal of the one-year requirement for opioid addiction before patient admission to an OTP would generally be contingent upon increasing resource use associated with such admission.

b. Estimated Costs of Reporting Burdens for OTPs and Accreditation Bodies

In developing its estimates of the potential costs of the proposed regulation, the Department relied substantially on recent estimates of burden and cost pertaining to requirements set forth in 42 CFR part 8.

Hourly labor costs involved in reporting requirements vary greatly between programs. Based on wage estimates obtained from the U.S. Department of Labor, Bureau of Labor Statistics, and Occupational Employment Statistics website, it is estimated that employees involved in complying with reporting requirements range from minimum wage ($7.25) clerical workers, to counselors averaging $22.14 an hour, managers, licensed practical nurses and registered nurses averaging $35.36 per hour, administrators averaging $52.58 per hour, and physicians averaging $96.26 per hour. The estimated average hourly wage for program personnel involved in reporting requirements, calculated as a simple mean, is $42.71. Multiplying the estimated average hourly wage by 2.0 to account for fringe benefits and overhead costs, an estimated hourly labor cost of $85.42 is obtained. The cost to accreditation bodies for applying for initial and ongoing approval with Form SMA-163, as well as for complying with the reporting requirements under 42 CFR 8.4 and 8.6 may be estimated at $33,672.56, using the $85.42 hourly cost figure. The estimated total annualized cost to the treatment program respondents for preparing the Form SMA-162 and for complying with other reporting requirements pursuant to 42 CFR 8.11, 8.24, 8.25, 8.26, and 8.28, using $85.42 as the hourly cost figure, is $16,140.11.

c. Cost Pertaining to Recordkeeping

The recordkeeping requirements set forth in 42 CFR 8.4 and 8.12 include maintenance of the following: a patient's medical examination when admitted to treatment; a patient's history; a care plan; any prenatal support provided to the patient; justification of unusually large initial doses; changes in a patient's dosage schedule; the rationale for decreasing a patient's clinic attendance; services provided; and documentation of physiologic tolerance.

SAMHSA believes that the recordkeeping requirements are customary and usual practices within the medical and behavioral health treatment communities. Accreditation bodies also maintain accreditation records for 5 or more years as a customary and usual practice. SAMHSA has neither calculated a response burden nor a cost burden for these activities.

d. Costs Pertaining to Disclosure

The proposed rule includes requirements that OTPs and accreditation organizations disclose information. For example, § 8.12(e)(1) requires that a practitioner explain the facts concerning the use of MOUD to each patient. This type of disclosure is consistent with common medical practice and is not considered an additional burden. Further, the rule requires, under § 8.4(i)(1), that accreditation organizations shall make public their fee structure. This type of disclosure is standard business practice and is not considered a burden in this analysis.

e. Estimate of Annualized Non-Hourly Cost Burden to Respondents

The proposed rule does not impose new capital or startup costs beyond the normal office and laboratory equipment required for achieving regulatory compliance. It is estimated that there are some costs associated with preparation for the accreditation site visit itself; assuming that OTP staff spend approximately 180 hours preparing for the site visit at an average cost of $85.42 per hour and an average of 1.33 site visits per facility, the total cost would be $20,450 or an annualized cost of $15,376 per facility. For the current approximately 1,920 affected OTPs these total annual costs are estimated to be $29,521,920. The percentage of this total cost that is associated with recordkeeping and reporting-only is difficult to estimate, but it is considered to be a small fraction of the total associated with accreditation.

i. Estimate of Annualized Cost to the Government

The total annualized cost to SAMHSA for administering 42 CFR part 8 is estimated at $450,000. This estimate includes the cost of an outside contractor to develop and maintain an extensive on-line system for SAMHSA, opioid treatment programs, State opioid treatment authorities, accreditation organizations, and others to have use a protected website for day-to-day regulatory activities. This estimate does not include funds that SAMHSA/CSAT allocates to its “look back” program that monitors the adequacy of accreditation surveys. Of this amount, the total annualized cost to SAMHSA for Paperwork Reduction Act activities as a result of this regulation is estimated as $221,434, as shown in the following table.

2. Consideration of Regulatory Alternatives

The Department has initiated rulemaking to make flexibilities issued during the COVID-19 PHE permanent, while also updating accreditation and treatment standards to reflect evidence-based practices and current medical terminology and approaches to OUD treatment given the current overdose crisis. The alternative would be to allow the current flexibilities to lapse with the end of the COVID-19 PHE, or to renew them periodically as may be needed during future emergencies or changed circumstances.

3. Request for Comments on Costs and Benefits

The Department requests public comment on all the estimates, assumptions, and analyses within the cost-benefits analysis. As part of this request, feedback is welcome on the extent to which cited papers follow sound scientific practices, such as: clearly stating null hypotheses and presenting estimating equations; ensuring that appendices or other supplementary materials are available online, if claimed to be so in the main body of a paper; using compelling identification strategies if making causal claims (for example, establishing parallel trends pre-intervention if using a difference-in-differences method ); and avoiding the types of errors that Kim et al. (2020 ) and Sanders et al. (2016 ) indicate are common in published cost-effectiveness analyses. The Department also requests comments on any relevant information or data that would inform a quantitative analysis of proposed reforms that the Department qualitatively addresses in this RIA. The Department also requests comments on whether there may be other indirect costs and benefits resulting from the proposed changes in the proposed rule and welcomes additional information that may help quantify those costs and benefits.

B. Regulatory Flexibility Act

The Department has examined the economic implications of this proposed rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act (RFA) requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. The Act defines “small entities” as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA), (2) a nonprofit organization that is not dominant in its field, and (3) a small government jurisdiction of less than 50,000 population. Because 90 percent or more of all health care providers meet the SBA size standard for a small business or are nonprofit organizations, the Department generally treats all health care providers as small entities for purposes of performing a regulatory flexibility analysis. The SBA size standard for health care providers ranges between a maximum of $8 million and $41.5 million in annual receipts, depending upon the type of entity.

For the reasons stated above, it is not expected that the cost of compliance would be significant for OTPs or accreditation bodies. Therefore, this proposed rule would not result in a significant negative impact.

C. Unfunded Mandates Reform Act

Section 202(a) of The Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending that may result in expenditures in any one year of $100 million in 1995 dollars, updated annually for inflation. As of 2022, this threshold is $165 million. The Department does not anticipate that this proposed rule would result in the expenditure by state, local, and tribal governments, taken together, or by the private sector, of $165 million or more in any one year.

D. Executive Order 13132—Federalism

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. The Department does not believe that this rulemaking would have any significant federalism implications, impose significant costs on state or local governments or preempt state law.

E. Assessment of Federal Regulation and Policies on Families

Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal departments and agencies to determine whether a proposed policy or regulation could affect family well-being. If the determination is affirmative, then the Department or agency must prepare an impact assessment to address criteria specified in the law. The Department believes that the proposed regulations would positively impact the ability of patients and families to access treatment for OUD. The Department does not anticipate negative impacts on family well-being as a result of this rulemaking as described.

F. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13), agencies are required to submit to the Office of Management and Budget (OMB) for review and approval any reporting or recordkeeping requirements inherent in a proposed or final rule, and are required to publish such proposed requirements for public comment. The PRA requires agencies to provide a 60-day notice in the Federal Register and solicit public comment on a proposed collection of information before it is submitted to OMB for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that the Department solicit comment on the following issues:

1. Whether the information collection is necessary and useful to carry out the proper functions of the agency;

2. The accuracy of the agency's estimate of the information collection burden;

3. The quality, utility, and clarity of the information to be collected; and

4. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

The PRA requires consideration of the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section. The Department explicitly seeks, and will consider, public comment on its assumptions as they relate to the PRA requirements summarized in this section.

As discussed below, the Department estimates a total OTP burden associated with all information collections of 1,868.95 hours, and a total number of burden hours for accreditation body respondents of approximately 394.70 hours each year. The annual burden associated with this rule and the associated forms is therefore estimated to be 2,263.65 hours.

1. Explanation of Estimated Annualized Burden Hours for 42 CFR Part 8

The Department presents, in separate tables below, burden estimates for the annual reporting requirement for accreditation bodies and also OTPs pursuant to the proposed rule.

The tables above reflect current estimates of burden, as the proposed rule does not effectively add or alter new reporting requirements. The estimates are derived from SAMHSA's data and are reflective of work from over the preceding twelve months. Further to this, the estimates of burden do not substantially differ from previously submitted estimates provided to The Office of Management and Budget.

The proposed rule does not alter reporting requirements as these have been shown to be effective in the safe administration of OTPs. The accreditation system provides effective oversight, while OTP reporting requirements support accreditation activities and the provision of safe treatment. Further to this, the proposed rule retains requirements that OTP's and accreditation organizations disclose information related to patient care and clinic policies and procedures for the treatment of OUD with MOUD. For example, § 8.12(e)(1) requires that a qualifying health care practitioner explain the facts concerning the use of MOUD to each patient. This type of disclosure is considered to be consistent with common medical practice and is not considered an additional burden. Further, the requirement under § 8.4(i)(1) that each accreditation organization shall make public its fee structure is considered standard business practice and is not considered a burden in this analysis.

List of Subjects in 42 CFR Part 8

• Administrative practice and procedure
• Health professions
• Methadone
• Reporting and recordkeeping requirements
• Substance misuse

For the reasons stated in the preamble, the Department of Health and Human Services proposes to revise 42 CFR part 8 to read as set forth below:

PART 8—MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER

Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.

Subpart A—General Provisions

Subpart B—Accreditation of Opioid Treatment Programs

Subpart C—Certification and Treatment Standards for Opioid Treatment Programs

Subpart D—Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body

Subpart E [Reserved]

Subpart F—Authorization To Increase Patient Limit to 275 Patients