7528 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

1See 21 U.S.C. 823(h)(1)–(3). 2For readability, the Department refers to specific 

sections of 42 CFR part 8 using a shortened citation 

with the ‘‘§ ’’ symbol except where necessary to 

distinguish title 42 citations from other CFR titles, 

such as title 45 CFR, and in footnotes where the full 

reference is used. 

3See 42 CFR 8.1 

4The terms ‘‘narcotic drugs’’ and ‘‘detoxification 

treatment’’ included in this paragraph are found in 

statute. SAMHSA recognizes that these terms can be 

stigmatizing for some people, and not aligned with 

current terminology. SAMHSA uses ‘‘opioid agonist 

medications’’ (see Treatment Improvement Protocol 

(TIP) 63) as an alternative to ‘‘narcotic drugs’’ and 

‘‘withdrawal management’’ as the alternative to 

‘‘detoxification treatment’’. 

5Formally under 21 U.S.C. 823(h)(2)(B)(iii) 

6Formally under 21 U.S.C. 

823(h)(2)(B)(iii)(II)(dd). See https://www.govinfo.

gov/content/pkg/USCODE-2016-title21/html/ 

USCODE-2016-title21-chap13-subchapI-partCsec823.htm. 

7See https://www.samhsa.gov/sites/default/files/ 

otp-guidance-20200316.pdf and https://

www.samhsa.gov/sites/default/files/faqs-for-oudprescribing-and-dispensing.pdf. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

42 CFR Part 8 

RIN 0930–AA39 

Medications for the Treatment of 

Opioid Use Disorder 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Department of Health and 

Human Services (‘‘HHS’’ or ‘‘the 

Department’’). 

ACTION: Final rule. 

SUMMARY: This final rule modifies and 

updates certain provisions of 

regulations related to Opioid Treatment 

Program (OTP) accreditation, 

certification, and standards for the 

treatment of Opioid Use Disorder (OUD) 

with Medications for Opioid Use 

Disorder (MOUD) in OTPs. This 

includes making flexibilities put forth 

during the COVID–19 Public Health 

Emergency (PHE) permanent, as well as 

expanding access to care and evidencebased treatment for OUD. The final rule 

also removes all language and rules 

pertaining to the Drug Addiction and 

Treatment Act (DATA) Waiver from the 

regulations pursuant to the 

‘‘Consolidated Appropriations Act, 

2023’’. 

DATES: The effective date of this final 

rule is April 2, 2024, and the 

compliance date is October 2, 2024. 

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 

rule, responses to public comments, an 

impact statement, and other required 

regulatory analyses. 

Executive Summary 

A. Overview 

This regulation finalizes the 

Department’s proposed rule concerning 

Medications for the Treatment of Opioid 

Use Disorder published in the Federal 

Register on December 16, 2022 (87 FR 

77330). It also finalizes proposals found 

in the Department’s supplemental 

notice of proposed rulemaking 

concerning removal of the DATA–2000 

Waiver requirements issued in the 

Federal Register on February 13, 2023 

(88 FR 9221). The final rule makes 

changes to the Department’s existing 

regulations concerning OTPs at 42 CFR 

part 8. 

The Controlled Substances Act (CSA), 

under 21 U.S.C. 823(h)(1)-(3), 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.’’ 1 The 

Secretary’s standards authorized under 

section 823(h) have been published as 

regulations under part 8 of title 42 of the 

Code of Federal Regulations (‘‘42 CFR 

part 8’’ or ‘‘part 8’’).2 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.3

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(h)(1)’’ is 

described as an ‘‘Opioid Treatment 

Program’’ (OTP).4

On December 29, 2022, the 

‘Consolidated Appropriations Act, 2023’ 

(Pub. L. No: 117–328) was enacted, 

resulting in the removal of requirements 

to obtain a waiver from the registration 

requirements of 21 U.S.C. 823(h)(1) for 

qualifying practitioners seeking to 

dispense or prescribe schedule III, IV, or 

V controlled substances that are FDAapproved for use in ‘‘maintenance and 

detoxification treatment.’’ Practitioners 

with a waiver under section 823(h)(2) 

were limited in the number of patients 

with OUD they may treat at any one 

time, and depending on the 

practitioner’s experience or 

qualifications, this statutory limitation 

was set at either 30, 100, or 275.5 The 

Secretary was also authorized to change 

the patient limitations by regulation, 

and qualifying practitioners had to 

satisfy the requirements of 42 CFR 8.610 

through 8.655 ‘‘(or successor 

regulations)’’ in order to treat up to 275 

patients, which was the maximum 

number under the law.6

In this final rule, the Department 

modifies certain provisions of part 8 to 

update OTP accreditation and 

certification standards, as well as 

treatment standards for the provision of 

medications for opioid use disorder 

(MOUD) as dispensed by OTPs. 

Pursuant to the ‘Consolidated 

Appropriations Act, 2023’ (Pub. L. No: 

117–328), the final rule also removes 

language pertaining to requirements for 

individual practitioners to dispense 

(including by prescribing) certain types 

of MOUD with a waiver under 21 U.S.C. 

823(h)(2). SAMHSA has developed this 

final rule in consultation with the Drug 

Enforcement Administration. 

The final rule 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 

physical distancing and to preserve 

patient and OTP staff safety. In March 

2020, SAMHSA published guidance 

regarding flexibilities that could be 

leveraged in the provision of 

unsupervised doses of methadone and 

the use of telehealth when initiating 

buprenorphine.7 These flexibilities 

represented the first substantial change 

to OTP treatment and medication 

delivery standards in more than 20 

years, and their role in facilitating 

access to treatment is supported by 

research. 

This final rule not only makes these 

COVID–19-related flexibilities 

permanent, but also updates standards 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7529 

8Suen LW, Coe WH, Wyatt JP, Adams ZM, 

Gandhi M, Batchelor HM, Castellanos S, Joshi N, 

Satterwhite S, Pe ́rez-Rodrı ́guez R, Rodrı ́guez-Guerra 

E, Albizu-Garcia CE, Knight KR, Jordan A. 

Structural Adaptations to Methadone Maintenance 

Treatment and Take-Home Dosing for Opioid Use 

Disorder in the Era of COVID–19. Am J Public 

Health. 2022 Apr;112(S2):S112–S116. doi: 10.2105/ 

AJPH.2021.306654. PMID: 35349324; PMCID: 

PMC8965183. 

9 Kleinman MB, Felton JW, Johnson A, Magidson 

JF. ‘‘I have to be around people that are doing what 

I’m doing’’: The importance of expanding the peer 

recovery coach role in treatment of opioid use 

disorder in the face of COVID–19 health disparities. 

J Subst Abuse Treat. 2021 Mar;122:108182. doi: 

10.1016/j.jsat.2020.108182. Epub 2020 Oct 21. 

PMID: 33160763; PMCID: PMC7577312. 

10Suen LW, Castellanos S, Joshi N, Satterwhite S, 

Knight KR. ‘‘The idea is to help people achieve 

greater success and liberty’’: A qualitative study of 

expanded methadone take-home access in opioid 

use disorder treatment. Subst Abus. 

2022;43(1):1143–1150. doi: 10.1080/ 

08897077.2022.2060438. PMID: 35499469. 

11See 42 CFR 8.12(e)(1). 

12Substance Abuse and Mental Health Services 

Administration. Medications for Opioid Use 

Disorder. Treatment Improvement Protocol (TIP) 

Series 63 Publication No. PEP21–02–01–002. 

Rockville, MD: Substance Abuse and Mental Health 

Services Administration, 2021. 

13Ware OD, Frey JJ, Cloeren M, Mosby A, 

Imboden R, Bazell AT, Huffman M, Hochheimer M, 

Greenblatt AD, Sherman SA. Examining 

Employment and Employment Barriers Among a 

Sample of Patients in Medication-Assisted 

Treatment in the United States, Addictive Disorders 

& Their Treatment: December 2021—Volume 20— 

Issue 4—p 578–586 doi: 10.1097/ 

ADT.0000000000000295. 

14Tanz LJ, Dinwiddie AT, Snodgrass S, 

O’Donnell J, Mattson CL, Davis NL. A qualitative 

assessment of circumstances surrounding drug 

overdose deaths during the early stages of the 

COVID–19 pandemic. SUDORS Data Brief, No 2. 

Atlanta, GA: Centers for Disease Control and 

Prevention, U.S. Department of Health and Human 

Services; 2022. 

15See https://www.phe.gov/emergency/news/ 

healthactions/phe/Pages/default.aspx. 

16See https://www.hhs.gov/about/news/2023/05/ 

09/fact-sheet-end-of-the-covid-19-public-healthemergency.html 

17See https://www.hhs.gov/overdose-prevention/. 

See also https://www.whitehouse.gov/briefingroom/statements-releases/2022/04/21/fact-sheetwhite-house-releases-2022-national-drug-controlstrategy-that-outlines-comprehensive-path-forwardto-address-addiction-and-the-overdose-epidemic/ 

18 Data from the U.S. Department of Health and 

Human Services, Treatment Locator, at https://

findtreatment.gov/ 

19See 21 CFR 1306.07. 

20Substance Abuse and Mental Health Services 

Administration. (2015). Federal guidelines for 

opioid treatment programs. HHS Publication No. 

(SMA) PEP15–FEDGUIDEOTP. Rockville, MD: 

Substance Abuse and Mental Health Services 

Administration. 

to reflect an accreditation and treatment 

environment that has evolved since part 

8 went into effect in 2001. Accordingly, 

the Department is updating part 8 to 

promote practitioner autonomy; remove 

discriminatory 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.8 9 10

To this end, the definition of a 

practitioner has been modified to refer 

to a provider who is appropriately 

licensed by the State to prescribe 

(including dispense) medications. 

Admission criteria have been updated, 

as required by section 1252(b) of the 

‘Consolidated Appropriations Act, 

2023’, to remove significant barriers to 

entry, such as the one-year requirement 

for opioid use disorder (OUD),11 while 

also defining the scope and purpose of 

the ‘initial’ and ‘periodic’ medical 

examinations. The final rule also 

includes new definitions to expand 

access to evidence-based practices such 

as split dosing, telehealth and harm 

reduction activities. In addition, 

outdated terms such as ‘detoxification’ 

have been revised to remove 

stigmatizing language. 

The Department promotes practitioner 

autonomy and individualized care by 

finalizing the provision containing the 

criteria for unsupervised doses of 

methadone. This includes removal from 

sole consideration the length of time an 

individual has been in treatment and 

requirements for 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 change recognizes the 

importance of the practitioner-patient 

relationship and is consistent with 

modern substance use disorder 

treatment standards.12 It also allows for 

greater flexibility in creating plans of 

care that promote recovery activities 

such as employment or education, while 

also eliminating the barrier of frequent 

OTP visits for individuals without 

access to reliable transportation.13

Accreditation and certification 

standards have been updated to codify 

the use of online/electronic forms, and 

to reflect a modern treatment 

environment. 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 final rule also clarifies 

administrative issues pertaining to 

accreditation, mobile medication units 

and interim treatment. 

This final rule makes treatment in 

OTPs more accessible to patients, while 

also supporting evidence-based and 

patient-centered care. In creating these 

changes, SAMHSA has relied on 

published evidence, stakeholder 

feedback, public comments to the 

proposed rule and the need to expand 

access to care in the face of a growing 

overdose epidemic, exacerbated by the 

COVID–19 pandemic.14 This is brought 

further into focus by the HHS 

declaration of a public health 

emergency for the opioid crisis which 

has been renewed regularly since 

2017.15 While the COVID–19 public 

health emergency expired as of May 11, 

2023,16 the lessons learned from the 

COVID–19 pandemic remain relevant 

for ensuring access to safe and effective 

substance use disorder treatment. The 

changes created by this final rule are 

expansive but are focused on 

permanently implementing the existing 

flexibilities and updating policies and 

practices that are based on evidence. In 

this way, SAMHSA believes that much 

of what is contained in the rule will not 

represent a significant burden for OTPs 

and, in fact, will reduce burdens and 

confer many benefits to providers and 

patients. The final rule, therefore, 

supports OTPs in their on-going 

provision of equitable and evidencebased care to often marginalized 

patients with OUD. The final rule also 

is consistent with the HHS Overdose 

Prevention Strategy and the National 

Drug Control Strategy, both of which 

call for increasing access to and the 

uptake of evidence-based treatments for 

substance use disorders.17

B. Background 

As of June 2023, there are over 2,000 

OTPs in the United States, providing 

care to over 650,000 patients.18 These 

are the only settings within which 

methadone, a schedule II opioid 

receptor agonist, can be legally provided 

to patients with OUD outside the 

context of hospital admission or certain 

other special circumstances.19

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. 

Such medications include methadone, 

buprenorphine, a schedule III partial 

opioid receptor agonist, and naltrexone 

which is an opioid receptor antagonist. 

For purposes of certification, OTPs must 

also offer adequate medical, counseling, 

vocational, educational, as well as other 

assessment and treatment services either 

onsite or by referral to an outside entity 

or practitioner.20

Practitioners treating OUD and the 

OTPs in which they practice must 

continuously adapt to evolving patterns 

of drug misuse. This is increasingly 


khammond on DSKJM1Z7X2PROD with RULES4
7530 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

21Centers for Disease Control and Prevention 

(CDC). Vital signs: overdoses of prescription opioid 

pain relievers—United States, 1999–2008. MMWR 

MorbMortal Wkly Rep. 2011 Nov 4; 60(43):1487– 

1492. 

22Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW, 

Carlson RE, Dao D, Davis JW, Dudek J, Eichler BA, 

Fernandes JC, Fondario A. Increases in heroin 

overdose deaths—28 states, 2010 to 2012.MMWR 

MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849. 

23 Gladden RM, Martinez P, Seth P. Fentanyl law 

enforcement submissions and increases in synthetic 

opioid-involved overdose deaths—27 states, 2013– 

2014. MMWR MorbMortal Wkly Rep. 2016; 65:837– 

43. 

24O’Donnell JK, Gladden RM, Seth P. Trends in 

deaths involving heroin and synthetic opioids 

excluding methadone, and law enforcement drug 

product reports, by census region—United States, 

2006–2015. MMWR MorbMortal Wkly Rep. 2017; 

66:897–903. 

25See https://www.samhsa.gov/sites/default/files/ 

colleague-letter-xylazine.pdf. 

26Ahmad FB, Cisewski JA, Rossen LM, Sutton P. 

Provisional drug overdose death counts. National 

Center for Health Statistics. 2023. 

27Wide-ranging online data for epidemiologic 

research (WONDER). Atlanta, GA: CDC, National 

Center for Health Statistics; 2023. Available at 

http://wonder.cdc.gov. 

28 Ibid. 

29For full text, see: https://

www.ncbi.nlm.nih.gov/books/NBK232108/ 

30See https://www.federalregister.gov/ 

documents/2016/07/08/2016-16120/medicationassisted-treatment-for-opioid-use-disorders. 

complicated by changes in controlled 

medication 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.21 By 

2010, however, the U.S. began to see 

rapid increases in overdose deaths 

involving heroin 22 and then by 2013, 

synthetic opioids other than 

methadone—primarily illicitly 

manufactured fentanyl—contributed to 

a further rise in overdose-related 

deaths.23 24 The introduction of xylazine 

into the illicit drug supply and its 

associated harms further adds to an 

evolving, complex, and dangerous 

situation.25

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 109,940 Americans died from 

a drug overdose in the 12-month period 

ending in January 2023.26 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 2021.27 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.28 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 adverse patient and 

public health outcomes. 

C. 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 at that 

time) in treatment and withdrawal 

management (referred to as 

detoxification at that time) of OUD. The 

final rule repealed the treatment 

regulations enforced by the Food and 

Drug Administration (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 1995 study, 

‘Federal Regulation of Methadone 

Treatment’ 29 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. The IOM report 

recommended that the FDA processoriented 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 organization 

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 

organization 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 

addressed accreditation and includes 

steps that Accreditation Bodies must 

follow to achieve approval to accredit 

OTPs. It also set forth the Accreditation 

Bodies’ responsibilities, including the 

use of accreditation elements during 

accreditation surveys. Subpart C 

described the sequence and 

requirements for obtaining certification 

and addressed how and when programs 

must apply for initial certification and 

renewal of their certification. Subpart D 

elucidated the procedures for review of 

the withdrawal of approval of the 

Accreditation Body or the suspension 

and proposed revocation of an OTP 

certification. 

Since publication of the final rule in 

2001, it has been updated on occasion 

to include new medications, such as 

buprenorphine, while also updating or 

adding new rules governing the 

provision of such medications. Subpart 

F, added in 2016, described criteria for 

increasing the patient limit for those 

practitioners meeting Federal 

requirements to prescribe 

buprenorphine to 275.30

On December 29, 2022, the 

‘Consolidated Appropriations Act, 2023’ 

(Pub. L. No: 117–328), was signed into 

law and immediately eliminated the 

requirement for individual practitioners 

to obtain a waiver to prescribe certain 

schedule III—V medications for the 

treatment of OUD, commonly known as 

the ‘‘DATA-Waiver.’’ Before the 

Consolidated Appropriations Act, 2023 

was enacted, ‘‘qualifying practitioners’’ 

were required to obtain waivers 

(formerly under 21 U.S.C. 823(h)(2)) 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7531 

31SAMHSA treatment locator. See https://

dpt2.samhsa.gov/treatment/directory.aspx. 

32See https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/methadone-guidance; and https://

www.samhsa.gov/medications-substance-usedisorders/statutes-regulations-guidelines/ 

buprenorphine-at-opioid-treatment-programs 

33https://www.ecfr.gov/current/title-42/chapter-I/ 

subchapter-A/part-8?toc=1. 

34HHS Guidance for Opioid Treatment Programs. 

https://www.samhsa.gov/sites/default/files/otpguidance-20200316.pdf. 

35See https://www.samhsa.gov/sites/default/files/ 

otp-guidance-20200316.pdf. 

36See https://www.samhsa.gov/sites/default/files/ 

faqs-for-oud-prescribing-and-dispensing.pdf. 

37Hatch-Maillette MA, Peavy KM, Tsui JI, BantaGreen CJ, Woolworth S, Grekin P. Re-thinking 

patient stability for methadone in opioid treatment 

programs during a global pandemic: Provider 

perspectives. J Subst Abuse Treat. 2021 

May;124:108223. doi: 10.1016/j.jsat.2020.108223. 

Epub 2020 Dec 5. PMID: 33342667; PMCID: 

PMC8005420. 

38 Joseph G, Torres-Lockhart K, Stein MR, Mund 

PA, Nahvi S. Reimagining patient-centered care in 

opioid treatment programs: Lessons from the Bronx 

during COVID–19. J Subst Abuse Treat. 2021 

Mar;122:108219. doi: 10.1016/j.jsat.2020.108219. 

Epub 2020 Dec 3. PMID: 33353790; PMCID: 

PMC7833302. 

39 ‘‘To Save Lives From Opioid Overdose Deaths, 

Bring Methadone Into Mainstream Medicine’’, 

Health Affairs Forefront, May 27, 2022. 

40 Krawczyk, N., Rivera, B. D., Levin, E., & 

Dooling, B. C. E. (2023). Synthesizing evidence of 

the effects of COVID–19 regulatory changes on 

methadone treatment for opioid use disorder: 

implications for policy. The Lancet. Public health, 

8(3), e238–e246. https://doi.org/10.1016/S2468- 

2667(23)00023-3 

41The 2022 American Association for the 

Treatment of Opioid Dependence (AATOD) 

Conference, Baltimore, Maryland, October 30— 

November 3, 2022. 

42NIDA. 2018, June. Medications to Treat Opioid 

Use Disorder. Retrieved from https://

irp.drugabuse.gov/wp-content/uploads/2019/12/ 

NIDA-Medications-to-treat-opioid-use-disorder_

2018.pdf. 

43Figgatt, MC, Salazar Z, Day E, Vincent L, 

Dasgupta N. Take-home dosing experiences among 

persons receiving methadone maintenance 

treatment during COVID–19, Journal of Substance 

Abuse Treatment, Volume 123, 2021, https://

doi.org/10.1016/j.jsat.2021.108276. 

44 Dooling, B.C.E. & Stanley, L.E. (2021). 

Unsupervised use of opioid treatment medications: 

Report II of the extending pandemic flexibilities for 

opioid use disorder treatment project. GW 

Regulatory Studies Center. https://regulatory

studies.columbian.gwu.edu/unsupervised-useopioid-treatment-medications. 

45 Jones, C. M., Compton, W. M., Han, B., 

Baldwin, G., & Volkow, N. D. (2022). MethadoneContinued 

from the separate DEA registration 

requirement, under 21 U.S.C. 823(h), 

that is needed to enable dispensing of 

certain controlled medications used in 

maintenance or withdrawal 

management (‘‘detoxification’’) 

treatment of OUD. Section 1252(b) of 

the ‘Consolidated Appropriations Act, 

2023’ (Pub. L. No: 117–328) also 

required removal of the one-year history 

of opioid misuse prior to admission to 

an OTP. This was included in the part 

8 NPRM (87 FR 77330), and public 

comments supported the change. 

In 2001 there were close to 900 OTPs, 

but that number has grown to over 2,000 

by 2023.31 Over this period, the 

incidence of fentanyl misuse has 

increased, escalating with the onset of 

the COVID–19 pandemic 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 take-home doses of 

methadone and initiation of 

buprenorphine via telehealth, including 

through audio-only platforms, that 

allowed for continued treatment of OUD 

with reduced direct patient contact. 

Each of these flexibilities represented a 

significant change to previous treatment 

standards and are discussed in detail 

below. It is important to note that 

SAMHSA has issued extensions to both 

the initiation of buprenorphine via 

telehealth flexibility and methadone 

take-home flexibility, effective upon 

expiration of the COVID–19 Public 

Health Emergency, and in effect for the 

period of one year from the end of the 

COVID–19 Public Health Emergency, or 

until such time that the U.S. Department 

of Health and Human Services 

publishes final rules revising 42 C.F.R 

part 8, whichever occurs sooner.32

Flexibility For Methadone Medication 

Take-Home Doses 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-home doses 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 8.33 These criteria can pose 

disruption to employment, education 

and other 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 permitted 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.34 With this 

flexibility, SAMHSA allowed OTPs to 

dispense up to 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.’’ 35 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 . . . .’’ 36

The intention of the methadone takehome 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 may 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, attend school, 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,37 OTPs,38 and State 

authorities.39 Patients reported that 

increased take-home doses of 

methadone left them feeling more 

respected as responsible 

individuals.37 40 In a national 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.41 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.42 Additionally, a survey 

found that diversion of methadone is 

low among patients receiving take-home 

doses under the COVID–19 PHE 

flexibility.43 44 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.45


khammond on DSKJM1Z7X2PROD with RULES4
7532 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

Involved Overdose Deaths in the US Before and 

After Federal Policy Changes Expanding TakeHome Methadone Doses From Opioid Treatment 

Programs. JAMA psychiatry, e221776. Advance 

online publication. https://doi.org/10.1001/ 

jamapsychiatry.2022.1776. 

46See https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/methadone-guidance 

47Bashshur, R. L., Shannon, G. W., Bashshur, N., 

& Yellowlees, P. M. (2016). The empirical evidence 

for telemedicine interventions in mental disorders. 

Telemedicine and e-Health, 22(2), 87–113. 

48Lustig, T. (2012). The role of telehealth in an 

evolving health care environment: Workshop 

summary. National Academies Press. 

49Mace, S., Boccanelli, A., & Dormond, M. (2018). 

The use of telehealth within behavioral health 

settings: Utilization, opportunities, and challenges. 

University of Michigan School of Public Health, 

Behavioral Health Workforce Research Center. 

50American Medical Association (2019). 

Telehealth implementation playbook. Digital Health 

Implementation Playbook Series. https://www.amaassn.org/system/files/2020-04/ama-telehealth

implementation-playbook.pdf 

51Uscher-Pines, L., Cantor, J., Huskamp, H. A., 

Mehrotra, A., Busch, A., & Barnett, M. (2020). 

Adoption of telemedicine services by substance 

abuse treatment facilities in the U.S. Journal of 

Substance Abuse Treatment, 117, 108060. 

52Melamed OC, deRuiter WK, Buckley L, Selby 

P. Coronavirus Disease 2019 and the Impact on 

Substance Use Disorder Treatments. Psychiatr Clin 

North Am. 2022 Mar;45(1):95–107. doi: 10.1016/ 

j.psc.2021.11.006. Epub 2021 Nov 12. PMID: 

35219445; PMCID: PMC8585604. 

53Substance Abuse and Mental Health Services 

Administration. Medications for Opioid Use 

Disorder. Treatment Improvement Protocol (TIP) 

Series 63 Publication No. PEP21–02–01–002. 

Rockville, MD: Substance Abuse and Mental Health 

Services Administration, 2021. 

54William T. McDermott, DEA Dear Registrant 

letter, Drug Enforcement Administration (March 25, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-018)(DEA067)%20DEA%20state%20

reciprocity%20(final)(Signed).pdf. 

55Thomas W. Prevoznik, DEA Dear Registrant 

letter, Drug Enforcement Administration (March 31, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20

buprenorphine%20telemedicine%20

%20(Final)%20+Esign.pdf 

56OTPs are authorized to dispense narcotic 

maintenance and detoxification medication under 

21 U.S.C. 823(h)(1) and regulated under 42 CFR part 

8. 

57See https://www.samhsa.gov/sites/default/files/ 

faqs-for-oud-prescribing-and-dispensing.pdf. 

58 Guille, C., Simpson, A. N., Douglas, E., Boyars, 

L., Cristaldi, K., McElligott, J., Johnson, D., & Brady, 

K. (2020). Treatment of opioid use disorder in 

pregnant women via telemedicine: A 

nonrandomized controlled trial. JAMA Network 

Open, 3(1), e1920177-e1920177. 

59 King, V. L., Brooner, R. K., Peirce, J. M., 

Kolodner, K., & Kidorf, M. S. (2014). A randomized 

trial of web-based videoconferencing for substance 

abuse counseling. Journal of Substance Abuse 

Treatment, 46(1), 36–42. 

60 Vakkalanka, J. P., Lund, B. C., Ward, M. M., 

Arndt, S., Field, R. W., Charlton, M., & Carnahan, 

R. M. (2022). Telehealth Utilization Is Associated 

with Lower Risk of Discontinuation of 

Buprenorphine: a Retrospective Cohort Study of US 

Veterans. Journal of general internal medicine, 

37(7), 1610–1618. https://doi.org/10.1007/s11606- 

021-06969-1. 

61Tanz, L. J., Jones, C. M., Davis, N. L., Compton, 

W. M., Baldwin, G. T., Han, B., & Volkow, N. D. 

(2023). Trends and Characteristics of 

Buprenorphine-Involved Overdose Deaths Prior to 

and During the COVID–19 Pandemic. JAMA 

Recognizing the importance of this 

flexibility, SAMHSA released guidance 

on November 18, 2021, (subsequently 

updated on April 19, 2023) 46 that 

extended the methadone take-home 

flexibility for one year past the end of 

COVID–19 PHE (May 11, 2024), or until 

such time that the Department publishes 

this final rule, whichever occurs sooner. 

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.47 48 49 Between 2016 and 2019, use 

of telehealth, in general, doubled from 

14 to 28 percent 50 while substance use 

disorder (SUD) treatment, offered 

through telehealth over the same period, 

increased from 13.5 to 17.4 percent.51

This trend has rapidly increased 

between 2019 and 2021, due to the 

COVID–19 pandemic.52

The pandemic spurred use of 

telehealth for the treatment of OUD with 

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.53

In response to the COVID–19 PHE, as 

declared by Secretary Azar on January 

31, 2020, pursuant to the authority 

under section 319 of the Public Health 

Service Act (42 U.S.C. 247), the DEA 

granted temporary exceptions to the 

Ryan Haight Act and DEA’s 

implementing regulations under 21 

U.S.C. 802(54)(D), one of the seven 

distinct categories of telemedicine 

envisioned under the statutory 

definition of the practice of 

telemedicine. In order to prevent lapses 

in care, these exceptions allowed for the 

prescribing of controlled medications 

via telemedicine encounters even when 

the prescribing practitioner had not 

conducted an in-person medical 

evaluation of the patient. 

These telemedicine flexibilities 

authorized practitioners to prescribe 

schedule II–V controlled medications 

via audio-video telemedicine 

encounters, including schedule III–V 

narcotic controlled medications 

approved by the Food and Drug 

Administration (FDA) for maintenance 

and withdrawal management treatment 

of opioid use disorder via audio-only 

telemedicine encounters, provided that 

such prescriptions otherwise comply 

with the requirements outlined in DEA 

guidance documents, DEA regulations, 

and applicable Federal and State law. 

DEA granted those temporary 

exceptions to the Ryan Haight Act and 

DEA’s implementing regulations via two 

letters published in March 2020: the 

March 25, 2020 ‘‘Dear Registrant’’ letter 

signed by William T. McDermott, DEA’s 

then-Assistant Administrator, Diversion 

Control Division,54 and the March 31, 

2020 ‘‘Dear Registrant’’ letter signed by 

Thomas W. Prevoznik, DEA’s thenDeputy Assistant Administrator, 

Diversion Control Division.55

Building upon this, SAMHSA 

implemented OTP regulatory 

flexibilities designed to help address the 

impact of the COVID–19 pandemic on 

OTPs and their patients.56 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 was to 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, determined that an 

adequate evaluation of the patient could 

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’’,57

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,58 and that among 

those patients requiring treatment with 

buprenorphine, there are high levels of 

satisfaction with the use of telehealth 

services.59 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.58 60 Research 

also shows that there is no significant 

difference in client and provider ratings 

of therapeutic alliance when using 

telehealth technology platforms.59

Further to this, research demonstrates 

that actions to facilitate access to 

buprenorphine-based treatment for OUD 

during the COVID–19 pandemic were 

not associated with an increased 

proportion of overdose deaths involving 

buprenorphine.61


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7533 

network open, 6(1), e2251856. https://doi.org/ 

10.1001/jamanetworkopen.2022.51856 

62See: https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/buprenorphine-at-opioid-treatmentprograms 

63Chan B, Bougatsos C, Priest KC, McCarty D, 

Grusing S, Chou R. Opioid treatment programs, 

telemedicine and COVID–19: A scoping review. 

Subst Abus. 2022;43(1):539–546. doi: 10.1080/ 

08897077.2021.1967836. Epub 2021 Sep 14. PMID: 

34520702. 

64See https://www.federalregister.gov/ 

documents/2021/06/28/2021-13519/registrationrequirements-for-narcotic-treatment-programs-withmobile-components. 

65See https://www.samhsa.gov/medicationassisted-treatment/statutes-regulationsguidelines#mobile. 

66See https://www.samhsa.gov/newsroom/pressannouncements/202104070200 

On May 9, 2023, SAMHSA issued 

guidance 62 that extended the 

buprenorphine telehealth flexibility for 

OTPs for one year past the end of 

COVID–19 PHE, or until such time that 

the Department publishes this final rule, 

whichever occurs sooner. 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. 

This final rule permits initiation of 

buprenorphine at the OTP, by the OTP 

practitioner, if an OTP physician, 

primary care physician, or other 

authorized healthcare professional 

under the supervision of a program 

physician, determines that an adequate 

evaluation of the patient can be, or was, 

accomplished via audio-only or audiovisual telehealth technology. 

SAMHSA believes that evidence 

underlying the initiation of 

buprenorphine using telehealth also is 

applicable to the treatment of OUD with 

methadone, and warrants expanding 

access to methadone therapy by 

applying some of the buprenorphine inperson examination flexibilities to 

treatment with methadone in OTPs.63

However, SAMHSA also acknowledges 

that there are differences between these 

two medications. Accordingly, this final 

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 by the OTP 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 final rule is not 

applicable to, and does not authorize, 

the prescription of methadone pursuant 

to a telehealth visit. Instead, this 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 audiovisual 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 audio-visual telehealth platforms 

based on their disability has an equal 

opportunity to benefit from treatment 

with MOUD. Similarly, Federal civil 

rights laws prohibit discrimination on 

the basis of national origin (including 

language ability) and require recipients 

to take reasonable steps to provide 

meaningful access to LEP individuals. 

This 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 

allowance 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.64 On 

September 21, 2021, SAMHSA released 

guidance on the establishment of mobile 

and non-mobile medication units and 

allowable services.65 While part 8 

currently allows OTPs certified by 

SAMHSA to establish medication units 

(as defined under 42 CFR 8.2), the final 

rule further defines mobile units and 

clarifies potential services, interventions 

and accreditation processes. 

Additionally, the COVID–19 

pandemic highlighted the importance of 

providing harm reduction services to 

OTP patients. On April 7, 2021, the CDC 

and SAMHSA jointly announced that 

Federal funding could be used to 

purchase rapid fentanyl test strips (FTS) 

for drug checking purposes.66 This was 

proposed in part 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. 

On December 16, 2022, HHS issued a 

notice of proposed rulemaking (NPRM) 

entitled ‘Medications for the Treatment 

of Opioid Use Disorder’ (87 FR 77330). 

In that NPRM, the Department proposed 

to modify certain provisions of part 8 to 

update Opioid Treatment Program 

(OTP) accreditation and certification 

standards, treatment standards for the 

provision of medications for opioid use 

disorder as dispensed by OTPs, and 

requirements for individual 

practitioners eligible to dispense 

(including by prescribing) certain types 

of Medication for Opioid Use Disorder 

(MOUD) with a waiver under 21 U.S.C. 

823(h)(2). Proposed changes sought to 

make flexibilities put forth during the 

COVID–19 PHE permanent, and to also 

update standards to reflect an OTP 

accreditation and treatment 

environment that has evolved since 42 

CFR part 8 came into effect in 2001. To 

this end, the Department proposed to 

update part 8 by: removing outdated 

language; fostering a more patientcentered perspective; and reducing 

barriers to receiving care. These 

elements have been identified in the 

literature and in feedback as being 

essential to promoting effective 

treatment and retention in care provided 

by OTPs. 

To expand access to care, the 

Department proposed to update OTP 

admission criteria as described in 42 

CFR part 8. This included removal of 

the one-year requirement for opioid 

addiction before admission to an OTP, 

in favor of consideration of problematic 

patterns of opioid use. Indeed, 

evidence-based standards of care 

demonstrate that it is more prudent to 

admit those individuals who either: 

meet diagnostic criteria for active 

moderate to severe OUD; are in OUD 

remission; or are at high risk for 

recurrence or overdose. In conjunction 

with updated standards that include 

extended take-home doses of methadone 

and access to telehealth, this is likely to 


khammond on DSKJM1Z7X2PROD with RULES4
7534 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

67See https://www.samhsa.gov/sites/default/files/ 

samhsa-fy-2024-cj.pdf. 

68See https://www.samhsa.gov/find-help/ 

recovery? 

expand access while also improving 

retention in treatment. 

Additionally, the Department 

proposed to update 42 CFR part 8 to 

reflect evidence-based practice, 

treatment standards, and the workforce 

currently providing services in OTPs. 

Proposed changes included: expanding 

the definition of a treatment practitioner 

to include any provider who is 

appropriately licensed to dispense and/ 

or prescribe approved medications; 

addition of evidence-based paradigms of 

care such as split dosing, telehealth and 

harm reduction activities; removing 

outdated terms such as ‘detoxification’; 

review of criteria for provision of takehome doses of methadone; 

strengthening the patient-practitioner 

relationship through promotion of 

shared and evidence-based decision 

making; allowing for early access to 

take-home doses of methadone for all 

patients to promote flexibility in 

creation of plans of care that promote 

recovery activities such as employment 

or education, while also allowing those 

with unstable access to reliable 

transportation the opportunity to also 

receive treatment; promotion of mobile 

medication units to expand an OTP’s 

geographic reach; and review 

accreditation standards. The proposed 

changes sought to organize existing 

flexibilities and practice updates in a 

manner that makes them permanent and 

cohesive. 

Removal of DATA-Waiver Requirements 

Section 1262(a)(1) of the Consolidated 

Appropriations Act, 2023 (Pub. L. No: 

117–328), which was enacted on 

December 29, 2022, amended the CSA 

(21 U.S.C. 823(h)) by eliminating the 

requirement that practitioners obtain a 

waiver to prescribe certain schedule 

III—V medications for the treatment of 

opioid use disorder (OUD). This 

immediately removed the requirement 

for practitioners to submit a notification 

of intent and to receive the Drug 

Addiction Treatment Act of 2000 

(DATA)-Waiver before prescribing 

buprenorphine. 

Before the Consolidated 

Appropriations Act, 2023 was enacted, 

‘‘qualifying practitioners’’ were required 

to obtain waivers (formerly under 21 

U.S.C. 823(h)(2)) from a separate 

registration requirement, under 21 

U.S.C. 823(h), that is needed to enable 

dispensing of certain schedule II—V 

narcotic medications used in 

maintenance or detoxification 

treatment. Practitioners with a waiver of 

this kind were limited in the number of 

patients they could treat with this type 

of medication at any one time. 

In July 2016, SAMHSA published a 

final rule (81 FR 44711) that added 

‘subpart F’ to 42 CFR part 8 under the 

authority of former 21 U.S.C. 

823(h)(2)(B)(iii)(III). Among other 

things, subpart F authorized eligible 

practitioners with a waiver under 21 

U.S.C. 823(h)(2) to request approval to 

treat up to 275 patients under certain 

conditions. The December 16, 2022, 

NPRM entitled ‘Medications for the 

Treatment of Opioid Use Disorder’ (87 

FR 77330), proposed three changes to 

subpart F: (1) altering section headings 

to remove the current question-andanswer style and replacing it with a 

standard format; (2) updating Section 

8.610 to remove stigmatizing language 

and to also clarify that the 275-patient 

waiver is limited to three years in 

duration and; (3) removing Section 

8.635 to eliminate annual reporting 

requirements for practitioners approved 

to treat up to 275 patients. 

Pursuant to section 1262 of the 

Consolidated Appropriations Act, 2023, 

the Department published a 

supplemental notice of proposed 

rulemaking (SNPRM), entitled 

‘Medications for the Treatment of 

Opioid Use Disorder: Removal of the 

DATA–2000 Waiver Requirements’ (88 

FR 9221), on February 13, 2023. This 

SNPRM proposed to remove in its 

entirety subpart F of 42 CFR part 8 in 

addition to language throughout 42 CFR 

part 8 that specifically references or 

implicates the DATA–2000 waiver 

process. 

D. Analysis and Discussion of 

Comments 

On December 16, 2022, the 

Department published a notice of 

proposed rulemaking entitled 

‘Medications for the Treatment of 

Opioid Use Disorder’ (87 FR 77330). 

The public comment period ended on 

February 14, 2023, and a total of 373 

comments were received. On February 

13, 2023, the Department also released 

a supplemental NPRM entitled 

‘Medications for the Treatment of 

Opioid Use Disorder: Removal of the 

DATA–2000 Waiver Requirements’ (88 

FR 9221), to bring proposed changes to 

42 CFR part 8 rule into alignment with 

the ‘Consolidated Appropriations Act, 

2023’ (Pub. L. 116–260). The 

supplemental NPRM closed for public 

comments on March 14, 2023. An 

additional 27 comments were received, 

the majority of which pertained to the 

December 16, 2022, NPRM. 

General Comments 

Terminology Changes, and Reducing 

Stigma 

Comments conveyed widespread 

approval of terminology and language 

changes aimed at expanding care while 

also reducing stigmatization for patients 

receiving treatment for OUD. Some 

commenters noted that language 

changes alone will not be sufficient to 

eliminate, stigma, injustice, and 

institutionalized marginalization. 

Others were concerned that updated 

language was not accurate—for 

example, that it detracts focus from 

other forms of treatment. One 

commenter additionally suggested that 

SAMHSA and other authorities consider 

updating their organizations’ names to 

maintain consistency with 

destigmatizing language changes. Such 

changes have been proposed by 

SAMHSA and HHS,67 but not yet 

enacted by Congress as of this date. 

Another commenter suggested 

eliminating or reducing the 

requirements for random toxicology 

testing as an important method to 

further reduce stigma and loss of bodily 

autonomy among a population that has 

often faced violent and punitive 

treatment. They also suggest 

reexamining the differential regulation 

of methadone versus buprenorphine. 

Response: SAMHSA recognizes the 

role of language in perpetuating stigma 

and discrimination, and is committed to 

taking steps to use language that is 

positive, patient-centered, productive 

and inclusive. It recognizes that 

changing language, alone, will not 

immediately eliminate harms suffered 

by those struggling with and in recovery 

from substance use disorders. SAMHSA 

and its Federal, State, local, Tribal and 

territorial partners have been working to 

impact health equities and promote 

justice through its programs, services 

and regulations, as evidenced in the 

improvements made in this regulatory 

language. SAMHSA has also 

emphasized support for recovery and 

recovery services.68 It will take time to 

assure consistency of language 

throughout documents; changing names 

of Federal agencies requires legislative 

action. Toxicology testing is a clinical 

tool that is used to inform the treatment 

process, should never be used 

punitively, and must be conducted in a 

way that is respectful of the individual 

and in accordance with clinical and 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7535 

69See https://store.samhsa.gov/sites/default/files/ 

d7/priv/pep15-fedguideotp.pdf. 

70See https://store.samhsa.gov/sites/default/files/ 

d7/priv/pep15-fedguideotp.pdf. 

professional standards.69 Also, the 

different regulation of methadone (in 

schedule II) versus buprenorphine (in 

schedule III) stems from how these 

substances are scheduled and from how 

they are regulated under 21 U.S.C. 

823(h), which requires ‘‘practitioners 

who dispense narcotic drugs (other than 

narcotic drugs in schedule III, IV, or V) 

to individuals for maintenance 

treatment or detoxification treatment’’ to 

obtain an annual separate registration 

for that purpose. 

Error in Citations 

One commenter expressed concern 

that several cited research studies were 

not accurately interpreted as used for 

this NPRM. For example, citation 103 is 

used as justification for provision of 

counseling at OTPs, but the study was 

done in a primary care setting. Another 

commenter stated that the same 

reference, 103, is incorrect and the 

citation in the body does not match the 

DOI link—one references HIV testing in 

Africa while it appears they intend to 

reference the HSU study on psychiatric 

comorbidity. 

Response: SAMHSA made every effort 

to ensure that the citations listed were 

correct. The error noted with citation 

103 has been rectified. Within the body 

of the text, the citation is appropriate as 

the text explicitly describes this study 

and highlights that in combination with 

other evidence, a comprehensive 

approach to treatment is associated with 

improved outcomes. Indeed, the 

proposed rule also includes evidence 

from other settings such as Emergency 

Departments. It is important to note that 

economic analysis of OUD treatment 

interventions is uncommon and so 

assessment of such evidence requires 

consideration of all sources. 

Comments on Accreditation Standards 

One-Year Accreditation Following One 

Recommendation 

Many commenters opposed the 

proposed change under Section 8.4, that 

provides, based on their understanding, 

only one-year accreditations to OTPs 

with recommendations. They believe 

this change in accreditation regulations 

will essentially end three-year 

accreditations. Commenters stated that 

with the number of standard ratable 

elements it is unreasonable to expect 

facilities to meet every accreditation 

element. With about 1,400 elements 

evaluated during each survey, not 

having even one recommendation is an 

unobtainable standard for many OTPs. 

Commenters stressed that having such a 

high standard would result in a 

substantial number, if not all, of OTPs 

having to submit to an annual 

accreditation inspection. 

Response: Section 8.4 addresses the 

responsibilities of the Accreditation 

Bodies. Since 2001, Section 8.4(b), in 

response to noncompliant programs 

stated ‘‘(1) If an Accreditation Body 

receives or discovers information that 

suggests that an OTP is not meeting 

Federal opioid use disorder treatment 

standards, or if survey of the OTP by the 

Accreditation Body otherwise 

demonstrates one or more deficiencies 

in the OTP, the Accreditation Body 

shall as appropriate either require and 

monitor corrective action or shall 

suspend or revoke accreditation of the 

OTP, as appropriate based on the 

significance of the deficiencies.’’ The 

proposed rule retained language about 

noncompliance with one or more 

standards as it refined expectations for 

Accrediting Bodies’ follow up with 

these programs. Based on comments, 

this final rule clarifies the intent of this 

subpart and survey and accreditation 

requirements, while also explicitly 

clarifying that non-critical findings 

would not result in only a one-year 

accreditation. 

Implementation Schedule Not To 

Exceed 60 Days 

One comment drew attention to the 

33% reduction in time this proposed 

change allows for submitting an 

implementation schedule, pursuant to 

Section 8.4. The commenter believes 

this would introduce significant new 

barriers to the delivery of care to 

persons with OUD while doing nothing 

to improve the standard of care. Other 

commenters agreed that 60 days is an 

insufficient amount of time to 

adequately address recommendations in 

a manner that improves patient care. 

Response: SAMHSA thanks 

commenters for this information. Based 

on the comments, the time frames 

allotted for noncompliant OTPs to 

implement corrections in section 8.4 

were extended to 180 days. This 

recognizes that some corrective 

measures may take more than 60 days 

to successfully implement. 

Surveyor Subjectivity and Need for 

Flexibility 

In reference to Section 8.4, several 

commenters mentioned that 

accreditation surveys are affected by the 

subjective interpretations of individual 

auditors, and that this subjectivity 

contributes to their objection to one 

recommendation being a preclusion for 

a three-year accreditation. Some OTP 

guidelines may no longer be consistent 

with newly proposed rules and are 

inconsistent with current evidencebased practices. Further, several 

commenters urged flexibility in 

accreditation decisions as the unique 

situations of many OTPs prevents 

constant, exact compliance. In other 

words, commenters urged flexibility in 

decision making based on center needs 

and circumstances as well as the 

seriousness of the recommendation(s) 

and its effect on patient care and safety. 

Response: SAMHSA reviews the 

policies and procedures of all 

Accreditation Bodies, including those 

related to the training and supervision 

of surveyors. SAMHSA meets regularly 

with the Accrediting Bodies to assure 

consistency in the application and 

interpretation of 42 CFR part 8. It also 

reviews the performance of 

Accreditation Bodies by inspecting a 

selected sample of the OTPs accredited 

by the respective Body each year, and, 

under section 8.4 will receive reports of 

OTP surveys when deficiencies are 

discovered. Together, these help to 

ensure consistency across and within 

Accreditation Bodies. Following 

finalization of this rule, SAMHSA 

intends to update the 2015 Federal 

Guidelines for OTPs 70 to assure the 

OTP guidelines are consistent with 

newly proposed rules and with current 

evidence-based practices. 

Cost Burden 

Commenters reported concern that 

proposed changes to accreditation, in 

Section 8.4, will result in more frequent 

inspections, which will require 

significant time and financial 

expenditures. Commenters expressed 

their conviction that the increased 

frequency of inspections will take 

providers away from patient care and 

direct the focus of both providers and 

administrators away from patient needs. 

Furthermore, inspections have financial 

costs for OTPs; some commenters 

asserted that the cost to some OTPs of 

more frequent surveys might be more 

than the OTP can financially bear. Many 

commenters fear that the additional 

administrative and financial costs will 

lead to fewer OTPs and thus reduced 

options for patients in dire need of 

treatment. 

Response: SAMHSA has made 

changes to Section 8.4 of this final rule 

to respond to commenter concerns 

about potentially increased rates of oneyear accreditation results. In the final 

rule, Section 8.4(b) has been altered to 

not only clarify the criteria for one-year 

or three-year accreditation, but to also 


khammond on DSKJM1Z7X2PROD with RULES4
7536 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

71See https://www.cms.gov/newsroom/pressreleases/hhs-releases-new-guidance-encouragestates-apply-new-medicaid-reentry-section-1115- 

demonstration. 

72See https://www.samhsa.gov/sites/default/files/ 

2021-letter-state-authorities-mobile.pdf. 

73See https://www.samhsa.gov/medicationssubstance-use-disorders/become-accredited-opioidtreatment-program. 

remove potential misunderstanding 

around whether a specific number of 

recommendations might lead to less 

than three-year accreditations. Rather 

than implement a specific number of 

recommendations that might lead to less 

than three-year accreditation, the final 

rule determines the length of 

accreditation based on the severity of 

the non-compliance. With this 

clarification in the final rule, rates of 

one year accreditation and repeat 

surveys are not expected to increase. 

Comments on Treatment Standards 

MOUD Treatment Criteria Changes 

Commenters overwhelmingly 

conveyed support for discontinuing 

requirements for a one-year history of 

OUD to access treatment as well as 

support for those changes that update 

admission criteria for minors. Some 

commenters also suggested that 

SAMHSA should remove the 

requirement that individuals cannot 

initiate methadone treatment more than 

twice a year. 

Response: The final rule removes the 

requirement, previously at 8.12(e)(2), 

that minors are required to have had 

two documented unsuccessful attempts 

at short-term ‘‘detoxification’’, or 

withdrawal management, or drug-free 

treatment within a 12-month period to 

be eligible for maintenance treatment, 

and that those seeking withdrawal 

management, previously under 

8.12(e)(4), cannot initiate methadone 

treatment more than twice per year. 

Instead, OTPs shall ensure that patients 

are admitted to treatment by qualified 

personnel who have determined, using 

accepted medical criteria, that: the 

person meets diagnostic criteria for a 

moderate to severe OUD; the individual 

has an active moderate to severe OUD, 

or OUD in remission, or is at high risk 

for recurrence or overdose. There is 

nothing stated within the Federal 

regulations or statutes that limits the 

number of times a person can initiate 

treatment with methadone or any other 

medication. 

Interim Treatment 

Comments supported extending 

interim treatment from 120 days to at 

least 180. Commenters request the 

availability of interim maintenance 

treatment through all OTPs and not just 

public and private not-for-profit OTPs, 

pursuant to 8.12(j)(1). Some 

commentors suggested interim 

treatment provision in primary care 

providers’ offices. 

Response: Interim treatment was 

developed to expand access to OTP 

services in urgent circumstances. The 

proposed rule specifically amended the 

duration of interim treatment from 120 

days to 180 days so that on a temporary 

basis, a patient may receive services 

from an OTP, while awaiting access to 

more comprehensive treatment services. 

Language pertaining to public and notfor-profit OTPs has been removed from 

the final rule in order to expand access 

to interim treatment among all OTPs. 

This is done in recognition of a need to 

bring individuals into treatment and in 

response to public comment. 

Expanding the Definition of Long-Term 

Care Facilities 

There is widespread support among 

commenters for the addition of jails and 

prisons under the definition of longterm care facilities at 8.11(h)(3), thus 

expanding the waiver of OTP 

certification to better allow for equitable 

access to treatment and reduce the 

potential for civil rights violations. 

Group homes and withdrawal 

management programs are also 

mentioned by some commenters in this 

context, as well as any licensed nonhospital residential treatment programs 

with medical staffing, a DEA registration 

and the ability to administer/store/ 

dispense prescription medications. 

Several commenters also requested the 

removal of waiver language that 

specifies the OUD diagnosis be 

secondary to another condition. 

Response: Language has been added 

to the final rule, at Section 8.11(h)(3), to 

highlight that these flexibilities may 

apply to a correctional facility that has 

registered with the DEA as a hospital/ 

clinic. If a correctional facility has 

registered as a hospital/clinic, a 

physician or authorized staff may 

administer or dispense narcotic drugs to 

maintain or manage withdrawal for an 

inmate as an incidental adjunct to 

medical or surgical treatment of 

conditions other than addiction. Rules 

regarding controlled substance 

dispensing that is outside the context of 

OTPs, such as waiver language that 

specifies the OUD diagnosis be 

secondary to another condition, is 

beyond the scope of this rulemaking. 

SAMHSA notes that the Centers for 

Medicare & Medicaid Services released 

new guidance encouraging States to 

apply for a new Medicaid re-entry 

Section 1115 waiver demonstration 

project for those persons leaving jails 

and prisons that this final rule may help 

facilitate.71

Expanding Methods of Access via OTPs 

and Their Mobile Units 

Commenters support easing 

pathways, under section 8.11, for 

opening new OTPs by enacting changes 

to ease or eliminate barriers, such as 

extending certification periods, 

providing funding opportunities, or 

encouraging existing syringe service 

programs to grow into new OTPs. 

Commenters also support expanding 

geographical access at current OTPs by 

easing regulations on their mobile units. 

They remarked on transportation 

challenges for people with OUD and 

that having access to mobile units will 

assist those who otherwise might not be 

able to attend a clinic in a fixed 

location. 

Response: Recognizing the many 

pathways to expanding access, the final 

rule makes permanent flexibilities 

implemented during the COVID–19 PHE 

and updates the overall regulations to 

reflect ways in which the accreditation 

and treatment environment has evolved 

since part 8 went into effect in 2001. 

Proposed changes that facilitate delivery 

of comprehensive services in mobile 

units, such as the use of telehealth, have 

been made permanent as they reduce 

barriers to receiving care, among other 

goals. Regulations regarding mobile 

units were eased by the DEA and 

SAMHSA, and use of funds allocated to 

States under the Block Grant were 

approved for use in the purchase of 

mobile units.72 Some commenters 

reference State-specific regulations that 

limit mobile units, but Federal OTP 

regulations do not preempt separate 

State requirements. SAMHSA fully 

encourages and facilitates additional 

OTP applications.73

Expanding Methods of Access via Office 

and Community Settings 

Many commenters emphasized that 

methadone treatment must be allowed 

outside of OTPs, such as in office-based 

settings or dispensing in community 

pharmacies, as many communities do 

not have access to OTPs. Commenters 

asserted that this approach has been 

successfully implemented in other 

countries and SAMHSA must work with 

the DEA to move in this direction. 

Furthermore, this may help to address 

stigma associated with and criticism of 

some OTPs and will help promote the 

cultural view of OUD as a chronic 

disease that necessitates respectful 

patient-centered care. 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7537 

74See https://www.samhsa.gov/sites/default/files/ 

dear-colleague-letter-fda-samhsa.pdf. 

Response: The final 42 CFR part 8 

rule only applies to dispensing of 

methadone in OTPs. SAMHSA 

continues to work with Federal partners 

to explore ways through which access to 

MOUD might be expanded. 

Expanding the Definition of a 

Practitioner 

There was strong support from 

commenters regarding expanding the 

definition of providers, under Section 

8.2, who are able to prescribe or order 

medications. Commenters expressed 

that allowing licensed practitioners, 

such as physician assistants, nurse 

practitioners, and certified nurse 

midwives, will result in improved 

access to patients, especially in areas 

with a high level of provider shortages. 

There was further support to add 

pharmacists to the definition of 

qualified providers. Commenters felt 

that including pharmacists as qualified 

providers will further improve 

accessibility for people suffering with 

OUD. 

Response: Pursuant to the 

supplemental notice of proposed 

rulemaking entitled ‘Medications for the 

Treatment of Opioid Use Disorder: 

Removal of the DATA–2000 Waiver 

Requirements’ (88 FR 9221) 

requirements for staff credentials are 

finalized to include the definition of a 

practitioner as ‘‘a health care 

professional who is appropriately 

licensed by a State to prescribe and/or 

dispense medications for opioid use 

disorders and, as a result, is authorized 

to practice within an OTP’’. The scope 

of 42 CFR part 8 is also limited to 

activities within an OTP. 

One commenter requested 

clarification on the context of certified 

nurse-midwives (CNMs) practice with 

MOUD. Another commenter requested 

clarification on scope of practice for 

physician assistants and nurse 

practitioners prescribing methadone, as 

there appear to be more restrictions 

compared to buprenorphine. 

Response: As noted above, the 

definition of a practitioner was 

modified. However, not all States allow 

CNMs, nurse practitioners, physician 

assistants, or pharmacists to order 

methadone unless supervised by a 

physician. Notwithstanding additional 

flexibilities provided in this final rule, 

practitioners must continue to adhere to 

State requirements that may apply to the 

provision of methadone and scope of 

practice. As also noted, this final rule 

does not apply to the prescribing of 

methadone for OUD outside of OTPs. 

Food and Drug Administration (FDA) 

Approval of Testing Supplies 

Some commenters requested the 

removal of the proposed change 

requiring drug testing services be FDA 

approved, under Section 8.12(f)(6), as 

this would impede their ability to test 

for fentanyl with an instant testing 

method. Another commenter requested 

more clarity, stating that this rule could 

preclude what they view as medically 

necessary definitive testing at qualified 

laboratories, despite the lack of an FDA 

review pathway for such testing. As the 

drug supply continues to rapidly evolve, 

OTP medical directors need the 

flexibility to use the best available tests, 

regardless of FDA approval, to provide 

effective patient care. 

Response: SAMHSA has amended 

Section 8.12(f)(6) to specifically allow 

for distribution of testing strips for drug 

checking, to those patients who wish to 

test their supply for adulteration, where 

not prohibited by law. The final rule 

also clarifies that FDA approved tests be 

used when conducting random drug 

testing with patients, including urine or 

saliva samples, at the OTP. 

Support for Provision of Resources With 

Patient-Centered Care Plans 

Commenters were supportive of 

Section 8.12(5)(i) that requires OTPs to 

work with patients to provide additional 

services such as counseling and harm 

reduction (including education, testing, 

and treatment for HIV, viral hepatitis, 

and sexually transmitted infections 

(STIs) when helpful), but some 

commenters cautioned requiring 

provision of these services without 

establishing their funding and requested 

in the meantime that the language be 

amended to include assessment and 

referral. Additionally, comments 

overwhelmingly conveyed support for 

clarifying that attending counseling is 

not a condition of MOUD treatment, and 

that treatment plans should be patient 

centered. 

Response: Part 8 defines what is 

expected in the provision of methadone 

for the treatment of OUD. Although it is 

expected that OTPs plan for their fiscal 

viability to assure continuity of 

medication and other treatment 

services, funding and sustainability are 

beyond the scope of these regulations. 

OTPs are expected to offer adequate 

medical, counseling, vocational, 

educational, and other assessment, and 

treatment services either onsite or by 

referral to an outside agency or 

practitioner. The revisions in this final 

rule promote a patient-centered 

approach to care that does not make 

medication continuity contingent upon 

involvement in counseling services but 

fosters greater shared decision-making. 

The revisions also relaxed the 

requirement that an OTP have a formal 

documented agreement with outside 

agencies; under Section 8.12(f)(1) the 

final rule calls for a ‘‘documented 

agreement’’ to provide such services.74

Further Consideration of Tribal 

Communities 

Some commenters advocate for 

increased Tribal sovereignty by 

including Indian Tribes as potential 

Accreditation Bodies. Additionally, 

while the Indian Health Service is 

included in the list of exceptions for 

State law compliance, OTPs operated by 

Indian Tribes must also be included to 

align with Tribal sovereignty. 

Accordingly, when States or ‘‘State law’’ 

is referenced, they urge SAMHSA to 

also include Tribes or ‘‘Tribal law’’. 

Another commenter communicates 

concern about lack of safe transportation 

and funding to access treatment on 

some Tribal reservations, 

institutionalized racism and 

marginalization, as well as lack of 

positive integration of American Indian/ 

Alaska Native culture into treatment for 

those populations. The commenter 

indicates that it is vital that SAMHSA 

alter the rule to explicitly include 

addressing the needs of marginalized 

communities, including Tribes and 

Tribal entities. 

Response: SAMHSA recognizes the 

need for culturally supportive care that 

addresses race, ethnicity, Tribal 

sovereignty, sexual orientation, religion 

and 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 

in the NPRM was finalized in this rule 

to ensure that the care provided is 

consistent with the patient’s needs, and 

self-identified goals for treatment and 

recovery. SAMHSA encourages OTPs 

serving American Indians and Alaska 

Natives to implement culturally 

competent and patient-centered care. 

SAMHSA notes that it and other 

agencies have developed resources that 


khammond on DSKJM1Z7X2PROD with RULES4
7538 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

75See https://www.samhsa.gov/behavioralhealth-equity/ai-an. 

76Substance Abuse and Mental Health Services 

Administration. Medications for Opioid Use 

Disorder. Treatment Improvement Protocol (TIP) 

Series 63 Publication No. PEP21–02–01–002. 

Rockville, MD: Substance Abuse and Mental Health 

Services Administration, 2021. 

may be helpful in developing culturally 

sensitive approaches for AI/AN 

populations.75

The Department has not included 

‘Tribal law’ whenever ‘State law’ is 

referenced, as Tribal laws vary widely. 

Accordingly, understanding what the 

reference means, or its scope, in some 

situations may be ambiguous. Therefore, 

it would be inappropriate to include 

Tribal law in this context. 

Intake 

Commenters requested clarification 

on the application of the new intake 

rules under Section 8.12(f)(2). Some 

commenters requested that clarification 

include explicit descriptions of rule 

application to clinical scenarios such as 

care transitions from hospital or nonOTP settings to OTPs. Commenters were 

supportive of allowing non-OTP 

clinicians to complete the intake 

screening and full examinations to 

expedite access during this process, 

though some commentors specified that 

the OTP provider must later review and 

approve the exams completed outside of 

an OTP. Some commentors stated that 

more frequent regular medical exams 

may be helpful during the first year of 

treatment to ensure safety and efficacy 

of treatment. One commenter requested 

clarification as to whether the full 

physical exam includes a mental status 

exam or an assessment of psychiatric 

symptoms, due to the high incidence of 

such symptoms among these patients. 

Another commenter requested clarity as 

to whether methadone may be initiated 

during the 14-day grace period for full 

OTP intake and screening/full 

examination, as some State regulations 

interpret this differently. 

Response: The final regulations, 

under Section 8.12(f)(2)(a), facilitate 

initial screening to allow for medication 

to commence at time of initial intake; 

SAMHSA recommends methadone 

medication induction not be delayed 

until the full examination is 

completed.76 The purpose of the initial 

screening is to ensure that there are no 

contraindications to prescribing 

methadone; this may require a 

psychiatric screening or evaluation of 

psychiatric symptoms, if clinically 

indicated. If mental health is not 

assessed at the time of screening, it 

should be completed subsequently as 

part of the patient’s assessment to 

identify any service needs. Proposed 

regulations were finalized as written, 

since they explicitly address these 

comments. 

Commenters were concerned about 

the requirement to complete a 

psychosocial assessment within 14 

days, stating that patients often 

experience instability at the time of 

entry into treatment, which makes this 

difficult; some commenters suggest 

providing 30 days to complete the 

assessment. One commenter also 

requested an exception be provided to 

ensure patients diagnosed with OUD are 

not excluded from MOUD because of 

documented failure or that only 

documentation of reasonable effort to 

complete this assessment is required. 

Another commenter adds that this short, 

prescriptive timeframe is not always 

conducive to developing therapeutic 

rapport between patients and providers 

and may force programs to be overly 

restrictive, disrupting patient 

engagement at a critical time. 

Response: Patients entering treatment 

for OUD are often in crisis and this is 

the basis for the requirement that a 

complete psychosocial assessment be 

conducted within 14 days. This is 

especially important because the final 

rule allows patients new to treatment to 

receive up to 7 take-home doses of 

methadone. The psychosocial 

assessment informs part of the initial 

examination, and as such, it is the basis 

of continued assessment and 

management as indicated. There is no 

requirement for a definitive list of 

diagnoses to be created at this time. 

Rather, this is an opportunity to create 

a detailed plan of care which might 

include continued assessment and 

monitoring of psychosocial status. To 

facilitate timely completion of the 

assessment, the final rule includes 

flexibilities for the use of telehealth. 

Serology Testing 

For serology testing, comments 

recommend the patient should 

explicitly retain the right to refuse or 

defer testing unless the medical 

provider deems it necessary for patient 

safety. Others asked for clarification on 

the deadline (14-day or 30-day) stating 

that 8.12 (f)(2)(B)(iii) and (iv) as 

proposed appeared contradictory. 

Response: An individual patient 

always has the right to refuse testing, 

and this provision therefore has been 

clarified in the final rule. Specifically at 

8.12(f)(2)(i)(b), now states that a 

‘‘patient’s refusal to undergo lab testing 

should not preclude them from access to 

treatment, provided such refusal does 

not have the potential to negatively 

impact treatment with medications’’. In 

regard to the suggested 14-day or 30-day 

discrepancy, these timeframes refer to 

use of serology results: it is permissible 

to use serology results drawn no more 

than 30 days prior to admission to the 

OTP, or up to 14 days after admission 

to the OTP to complete the full 

examination. Thus, these two provisions 

are not inconsistent. 

Treatment Discharge Concerns 

Several comments expressed concern 

over removal of language in the 

proposed rule concerning discharge, 

asserting that this change removes 

important patient protections that have 

helped to promote humane discharge 

processes. Whether patients are 

discharged for nonpayment or other 

reasons, commenters emphasize that 

tapering schedules must be based on 

clinical and safety considerations. 

Response: The importance of 

discharge planning has been highlighted 

in the final rule. Specifically, under 

Section 8.11(f)(2)(iv) discharge 

decisions have been enumerated to 

require a patient-centered approach. 

Such decisions must be documented, 

and planned in a manner that ensures, 

to the greatest extent possible, that 

patient treatment is not disrupted. 

Proposed language from the NPRM 

pertaining to discharge planning 

throughout Section 8.12 has been 

finalized. 

Split Dosing 

Numerous commenters support the 

expansion of split dosing for all OTP 

patients receiving take-home doses, 

defined in Section 8.2, based on the 

clinical judgement of the OTP 

practitioner, and urge SAMHSA to add 

language specifying that additional 

testing and submission of 

documentation for split dosing is 

unnecessary if the clinician has clearly 

documented in the medical record that 

split dosing will benefit the patient. 

Commenters also emphasize that takehome doses are essential for split 

dosing, especially for pregnant patients 

and patients driving long distances to 

receive medication. 

Response: The final rule does not 

specify requirements of any additional 

testing or documentation beyond that of 

routine clinical practice. There is 

nothing in the final rule that precludes 

provision of split doses for take-home 

doses of methadone. 

Dosage During Treatment Induction 

At Section 8.12(h)(3)(ii) commenters 

emphasize that higher initial and next 

day doses are often clinically 

appropriate and necessary to prevent 

withdrawal and treatment attrition, 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7539 

especially for patients exposed to 

fentanyl, as well as for patients in the 

later stages of pregnancy, and that 

clinicians require more clarification on 

this. Commenters questioned whether 

the additional medication is 

administered as one higher dose or 

additional, incremental dose(s) at 

several hour interval(s). They worry that 

lack of clarity will result in 

underutilization and thus lower 

treatment retention. Some commenters 

suggest eliminating induction dosing 

guidelines (which they view as a 

reflection of longstanding stigma and 

discrimination against patients in OTP 

treatment). These commenters suggest 

entrusting these decisions to 

practitioners, noting that other 

medication dosage decisions for many 

medical conditions are left to judgment 

and discretion of medical providers. 

Some commenters also caution that 

higher induction doses must not be 

discouraged when medically necessary 

for efficacious treatment. 

Response: A primary purpose of the 

final rule is to promote use of clinical 

judgement as well as patient-centered 

care. These comments speak to the need 

for ‘‘shared decision-making’’ in the 

practitioner-patient relationship, and 

the final rule supports this through 

empowering practitioners to work with 

patients to create individualized plans 

of care. Section 8.12(h)(3)(ii) has been 

clarified in a manner that does not 

prohibit higher induction doses, but 

requires the rationale for higher 

induction doses to be documented in 

the patient’s record. 

Audio-Only Telehealth 

Commenters emphasize that audioonly telehealth is an important 

permanent provision for counseling and 

buprenorphine initiation to ensure more 

equitable access to OTPs. 

Response: SAMHSA agrees with 

commenters that telehealth, including 

audio-only telehealth, can be an 

important tool to enhance access to 

treatment. SAMHSA also recognizes 

scientific evidence that further supports 

integration of telehealth provisions in 

the final rule consistent with clinical 

guidelines and safety requirements. The 

final rule accordingly states that in 

evaluating patients for treatment with 

schedule III medications (such as 

Buprenorphine) or medications not 

classified as a controlled medication 

(such as Naltrexone), audio-visual or 

audio only platforms may be used at the 

patient and provider’s preference. For 

schedule II medications (such as 

Methadone), the rule allows for audiovisual telehealth initiation by the OTP 

practitioner. When audio-visual 

technologies are not available or their 

use is not feasible for a patient, it is 

acceptable to use audio-only devices, 

but only when the patient is in the 

presence of a licensed practitioner who 

is registered to prescribe (including 

dispense) controlled medications. This 

is because, as noted, in the proposed 

rule, schedule II medications such as 

methadone pose increased risk 

compared to schedule III medications 

such as buprenorphine. In all cases, 

medications for the treatment of OUD 

shall be ordered by the OTP 

practitioner. 

Audio/Visual Telehealth for Medical 

Intake and ‘‘Annual Physical’’ 

Appointments 

Video-based telehealth, under section 

8.12(f)(2)(B)(v), is overwhelmingly 

supported by commenters for medical 

intake, periodic medical assessments, 

and methadone or buprenorphine 

initiation by OTP practitioners. Onsite 

staff can supplement telehealth care by 

gathering vital sign and toxicology data, 

when necessary. One comment 

questioned if any appropriate limits, for 

example on the number of patients a 

single physician could oversee via 

telehealth should be added. 

Response: SAMHSA appreciates these 

comments and has finalized proposed 

changes in the final rule. Requirements 

pertaining to telehealth, including the 

number of patients that a practitioner 

may see, are governed by applicable 

State and Federal laws. As noted above, 

however, provisions in this final rule 

support use of telehealth as part of 

patient treatment. 

Take-Home or Unsupervised Doses 

Provisions expanding take-home or 

unsupervised methadone medication 

doses, under Section 8.12(i), are mostly 

supported, with commenters citing 

increased patient autonomy and pride, 

improved outcomes and treatment 

retention, and reduced barriers to 

treatment. The removal of the eight takehome criteria is accordingly supported 

by some, though others note that 

toxicology testing is important to help 

maintain public and patient safety. 

Some commenters expressed concern 

about potentially increased diversion, 

while another commented that 

diversion is a sign of unmet community 

need and should be addressed as such, 

rather than criminalized. Some 

commenters worried that the revised 

take-home allowances are too flexible 

and some proposed different guidelines; 

others supported them or even wanted 

them eliminated entirely, trusting 

providers with that responsibility. Yet, 

other commenters worried that leaving 

decisions about take-homes completely 

to the discretion of providers could 

result in provider abuse and suggested 

that some parameters are necessary. 

Many commenters expressed 

frustration that not all patients receive 

equitable access to take-homes, whether 

for insurance reasons or lack of clinic/ 

state implementation. Some 

commenters suggest the addition of 

take-home metrics during the OTP 

survey process to help address this. 

Another commenter suggested 

SAMHSA provide a method of recourse 

for patients dissatisfied with decisions 

made about their take-home eligibility. 

One commenter requested clarification 

on insurance coverage of take-home 

doses, specifically with Medicare or 

Medicare Part D. One commenter asked 

that SAMHSA end the requirement for 

requested program exceptions when 

closing or dispensing extra take-home 

doses for weather emergencies and state 

holidays, and that patient suitability 

documentation for days the clinic is 

closed is only required for patients 

denied take-home medication. 

Response: SAMHSA recognizes that 

its proposed provisions concerning takehomes were significant. Proposed 

changes have been finalized without 

alteration. While this approach 

promotes practitioner discretion, 

determining risk factors and preventing 

diversion has required team input since 

the original regulations were 

promulgated over 20 years ago. 

A standard for treatment that is 

common to all Accreditation Bodies is 

that OTPs have policies regarding 

patient complaints and procedures that 

protect patients from retaliation. 

SAMHSA requires that Accreditation 

Bodies have policies and procedures in 

place to respond to complaints received 

from the Secretary, patients, facility 

staff, and others. Therefore, patients 

who have complaints about take-homes 

shall have access to recourse through 

required patient complaint and 

grievance procedures. 

Determinations about insurance 

coverage and reimbursement for MOUD, 

while important, are outside the scope 

of this rulemaking. 

Need for More Data 

Several commenters expressed an 

ongoing need for more data to ensure 

treatment changes (such as additional 

take-home medication doses, induction 

dosing schedules, expansion of the 

definition of a qualified provider) are 

safe, especially post COVID–19 public 

health emergency (PHE) as 

circumstances and environments 

change. Some had concerns that 

changes provided too much flexibility, 


khammond on DSKJM1Z7X2PROD with RULES4
7540 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

77See https://reaganudall.org/news-and-events/ 

events/considerations-buprenorphine-initiationand-maintenance-care. 

78See https://heal.nih.gov/. 

79See https://www.acog.org/clinical/clinicalguidance/committee-opinion/articles/2015/06/ 

alcohol-abuse-and-other-substance-use-disordersethical-issues-in-obstetric-and-gynecologic-practice. 

especially with respect to take-home 

doses during the first week(s) of 

treatment, due to less patient stability/ 

functionality during this transitional 

period. Others mentioned that patients 

might handle medications differently 

outside of the COVID–19 PHE 

environment, due to lack of behaviormodifying factors present during the 

PHE, such as isolation and fear for 

continued treatment. Other commenters 

expressed the need for more data related 

to induction dosing and best practices 

for rapid induction to effective doses 

while minimizing risk. 

Response: Data is important to 

performance monitoring and 

evaluations of health care interventions. 

Accreditation standards require that 

OTPs have quality assurance systems 

that consider patient outcomes. The 

data related recommendations noted in 

these comments are items that could be 

incorporated into the OTPs quality 

assurance processes. These 

recommendations are better addressed 

in the revision of the Federal OTP 

guidelines that SAMHSA will complete 

following this rulemaking. SAMHSA 

and its partners, including the Centers 

for Disease Control and Prevention, FDA 

and National Institutes of Health (NIH), 

support further research on these issues, 

and SAMHSA will monitor the impact 

of this rule. As one example, FDA, 

SAMHSA and the Reagan-Udall 

Foundation held a meeting in May 2023 

regarding ‘Considerations for 

Buprenorphine Initiation and 

Maintenance Care’ to ‘‘explore realworld experiences and scientific 

evidence for buprenorphine initiation 

strategies as well as medication dosing 

and management during continued 

treatment across different care 

settings.’’ 77 SAMHSA and NIH 

similarly collaborate to support the 

Helping to End Addiction Long-term®

Initiative which focuses on improving 

pain treatment and developing 

community-level solutions to opioid 

addiction.78 SAMHSA will continue on 

its own and with other agencies and 

stakeholders to explore and support 

research on these issues. 

Pregnancy Testing 

Several commenters advised against 

requiring pregnancy testing, under 

Section 8.12(f)(B)(iii), for pregnant OTP 

patients. They reasoned that, in a time 

when States are increasingly restricting 

and even criminalizing reproductive 

options, pregnancy testing may dissuade 

patients of child-bearing potential from 

seeking treatment. 

Response: Pregnancy testing is often 

necessary for appropriate clinical care, 

and the final rule clarifies that 

pregnancy testing should be requested 

only when clinically appropriate, and 

that refusal of such testing should not 

preclude access to treatment. 

Safeguarding patient privacy and health 

is essential, and in all cases, providers 

must adhere to State and Federal laws 

and regulations, clinical requirements 

and professional guidelines when 

considering screening and disclosure of 

testing results. For instance, the 2015 

‘American College of Obstetricians and 

Gynecologists policy on Alcohol Abuse 

and Other Substance Use Disorders: 

Ethical Issues in Obstetric and 

Gynecologic Practice’, emphasizes the 

importance of patient informed consent 

for testing.79

Ramifications of Dependency Diagnosis 

One commenter expressed concern 

that under Section 8.12(f)(2), all patients 

receiving opioids must be documented 

in the medical chart with an opioid 

dependence diagnosis, even if the 

patient is a pain patient and the doctor 

has no dependency concerns. One 

commenter is concerned that this could 

affect eligibility for future organ 

transplants. 

Response: These regulations establish 

the procedures by which the Secretary 

of HHS determines whether a program 

is qualified to dispense methadone and 

other medications in the treatment of 

opioid use disorders and standards 

regarding the use of these medications 

for treatment purposes, in accordance 

with the Controlled Substances Act 

(CSA) under 21 U.S.C. 823(h). As a 

result, a diagnosis of opioid use disorder 

is required. SAMHSA notes that opioid 

dependence is an older diagnostic term 

that, in the U.S., has been replaced with 

the diagnostic term of opioid use 

disorder and associated diagnostic 

criteria. Proposed changes, as written, 

were finalized in the rule. 

Protecting Patient Data 

Central registries are often queried to 

detect and prevent potential multiple 

enrollments in more than one OTP. 

Central registries are briefly described in 

42 CFR part 2 (Confidentiality of 

Substance Use Disorder Patient Records) 

regulations, but one commenter is 

concerned that there do not appear to be 

limits on their collection and sharing of 

sensitive patient information and 

requests regulations better clarify 

appropriate practices. 

Response: Central registries are Statebased operations. Although the patient 

information is protected, procedures for 

assuring protection and relevant 

regulations such as 42 CFR part 2 and 

the Health Insurance Portability and 

Accountability Act are outside the scope 

of these Part 8 regulations. 

Alignment of State and Federal 

Guidelines 

There were many commenters that 

expressed concerns with State 

regulations as they intersect with 

proposed SAMHSA changes. If States 

have more restrictive regulations, 

especially related to medication 

administration, for instance, then 

patients in those States may not benefit 

from Federal changes, some commenters 

asserted. These commenters urged that 

States be required to align with Federal 

regulations, even if it means 

withholding funds to States who refuse 

to adopt new Federal regulations. Some 

commentors also requested language be 

added mandating State Opioid 

Treatment Authorities (SOTAs) are 

included in communications such as 

when and how an OTP is not meeting 

standards, withdrawal of approval of 

Accreditation Bodies, and others. 

Response: These rules do not mandate 

that States promulgate less restrictive 

rules to match provisions of Federal law 

that may provide more flexibility. 

SAMHSA works closely and 

collaboratively with the SOTAs and 

State mental health and substance use 

disorder treatment authorities, the 

Accreditation Bodies, as well as other 

Federal agencies to encourage State and 

Federal alignment and informationsharing. 

Other Themes 

There were two comments that urged 

keeping Levomethadyl acetate (LAAM) 

on the list of approved treatment 

medications. These comments suggested 

that research could indicate it is an 

effective treatment for opioid use 

disorder and that it may soon be 

available for use again. Additionally, 

other comments advocated integration 

of other FDA-cleared treatment options 

like neuromodulation and other medical 

technology. 

Response: Currently, LAAM is not 

available in the United States. For this 

reason, it was removed from the list of 

currently approved and available 

medications for OUD. The list provided 

in the rule is current, and there is 

nothing that precludes changes to the 

list of medications used to treat OUD in 

the future. Technology is not currently 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7541 

80NIDA. 2021, November 29. Words Matter— 

Terms to Use and Avoid When Talking About 

Addiction. Retrieved from https://nida.nih.gov/ 

nidamed-medical-health-professionals/healthprofessions-education/words-matter-terms-to-useavoid-when-talking-about-addiction. 

addressed in 42 CFR part 8 as devices 

and available applications are an 

adjunct to treatment with MOUD. 

SAMHSA will monitor the development 

and approval of new medical devices by 

FDA for the treatment of chronic opioid 

use disorder and will consider updates 

to part 8 as needed. 

E. Summary of the Final Rule 

The Department has finalized the 

following changes to 42 CFR part 8 that 

revise, delete, replace, or add sections. 

This section summarizes changes in the 

final rule, and discusses changes made 

after review of public comments on the 

NPRM entitled ‘Medications for the 

Treatment of Opioid Use Disorder’ (87 

FR 77330), and the SNPRM entitled 

‘Medications for the Treatment of 

Opioid Use Disorder: Removal of the 

DATA–2000 Waiver Requirements’ (88 

FR 9221). 

1. Title 

The Department has finalized the 

title, originally proposed in the NPRM, 

as being: Medications for the Treatment 

of Opioid Use Disorder. As discussed in 

the NPRM, this title reflects current 

medical terminology and removes 

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.80

The amended title reflects current 

medical terminology and highlights that 

OUD is a chronic, treatable condition. 

2. Subpart A 

Reorganization of subpart A, as 

proposed in the NPRM and SNPRM, has 

been finalized and includes the scope 

and definitions. 

3. Section 8.1—Scope 

Pursuant to the NPRM and SNPRM, 

§ 8.1 is finalized to reflect modern 

medical terminology, to detail updated 

acronyms, and for clarity. Of note, the 

term medication assisted treatment 

(MAT) has been updated to medications 

for opioid use disorder (MOUD), and the 

term treatment program has been 

changed to opioid treatment program 

throughout the final rule. Pursuant to 

proposed changes set forth in the 

SNPRM entitled ‘Medications for the 

Treatment of Opioid Use Disorder: 

Removal of the DATA–2000 Waiver 

Requirements’ (88 FR 9221), reference to 

subpart F has been removed. 

4. Section 8.2—Definitions 

Changes proposed by the NPRM and 

SNPRM have been finalized in § 8.2 to 

add, remove 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. Definitions for 

additional credentialing, approval term, 

covered medications, and emergency 

situation have been removed. 

5. Section 8.3—Application for 

Approval as an Accreditation Body 

Changes proposed by the NPRM are 

finalized to include 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. 

Furthermore, this regulation is updated, 

pursuant to the NPRM, to ensure that 

Accreditation Bodies provide training 

policies specifically related to training 

of survey team members. As described 

in the NPRM, the final rule also 

provides for Indian Tribes, in addition 

to State or territorial governments, to 

apply for approval as an Accreditation 

Body. 

6. Section 8.4—Accreditation Body 

Responsibilities 

In response to public comments, 

language that clarifies SAMHSA’s 

oversight of Accreditation Bodies, and 

associated expectations, has been 

updated and finalized. To this end, the 

Department has provided clarification 

on the 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. In particular, section 

8.4(b) of the final rule includes: 

provisions requiring categorization of 

the types of non-compliance; provisions 

that differentiate between accreditation 

duration based on the severity of noncompliance; and adds provisions 

detailing procedures for severe noncompliance. Time frames for submission 

of survey reports are also finalized. 

Pursuant to the NPRM, the Department 

has finalized the 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, as per 

the NPRM, the final rule adds a 

requirement that Accreditation Bodies 

notify SAMHSA of all aspects of a 

complaint response within 5 days of 

receipt. Similarly, the previous 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 finalized, pursuant to 

the NPRM, to update categories of 

certification, to clarify the requirement 

that OTPs maintain certification, and to 

establish procedures for OTPs whose 

certification has lapsed. Terms for the 

extension of certification are finalized, 

as are the means of requesting an 

extension. The final 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. 

As described in the NPRM, the final 

rule removes ‘‘Transitional 

certification’’ which expired as a 

category of certification in 2003. 

Further, 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. 

Pursuant to the NPRM, the conditions 

for approval of interim treatment have 

been finalized to increase the duration 

of interim treatment from 120 days to 

180 days, with the stipulation that 


khammond on DSKJM1Z7X2PROD with RULES4
7542 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

individuals shall not be discharged 

without the approval of an OTP 

practitioner while awaiting transfer to a 

comprehensive treatment program. In 

response to public comments on the 

NPRM, availability of interim treatment 

is also expanded to all OTPs. For clarity, 

reference to section 1923 of the Public 

Health Service Act (21 U.S.C. 300x–23) 

is removed. The NPRM and final 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. 

As described in the NPRM, the 

services that can be provided in 

medication units have been finalized 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, as 

described in the NPRM, are finalized in 

order 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 medications, has 

been removed and patient-centered 

language is added. 

The paragraph on staff credentials, 

found in the NPRM, is finalized to 

expand the definition of a practitioner 

to a ‘‘a health care professional who is 

appropriately licensed by a State to 

prescribe and/or dispense medications 

for opioid use disorders and, as a result, 

is authorized to practice within an 

OTP.’’ The expectation that all licensed 

and credentialed staff maintain 

licensure and/or certification has been 

finalized. 

Criteria for admission to treatment, as 

discussed in the NPRM, removes 

reference to the Diagnostic and 

Statistical Manual of Mental Disorders 

(DSM) IV and eliminates the 

requirement for a one-year history of 

OUD. Instead, the final rule 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 

finalized to ensure 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 altered to the 

extent that 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 finalized so 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 correctional 

settings, pregnant patients or previously 

enrolled individuals has been removed. 

Throughout the document, as 

described in the NPRM, 

‘‘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 paragraph on ‘‘Required services’’ 

is finalized to incorporate patientcentered language, establish flexible 

terminology, promote use of clinical 

judgment, and clarify SAMHSA’s 

expectations of OTPs. The final 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 finalized, 

pursuant to the NPRM, 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 final 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 at the OTP, by 

the OTP practitioner, has also been 

finalized in the rule. Additionally, the 

paragraph on special services for 

pregnant people is finalized to specify 

that confirmation of pregnancy should 

be requested for priority treatment 

admissions. The option to use split 

dosing for patients, as described in the 

NPRM, is also finalized. 

The components of initial and 

periodic medical examinations have 

been finalized, pursuant to the NPRM, 

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 finalized so 

as to assure information is gathered in 

the context of the patient’s whole life 

such as their mental health, housing, 

recovery support and harm reduction 

resources. Additionally, patientcentered language has been finalized, 

such as ‘‘services a patient needs and 

wishes to pursue’’. 

The final rule expands the provision 

of ‘counseling services’ that are 

provided by OTPs 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 finalized 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 finalized to remove 

the word ‘‘formal’’; the final rule calls 

for a ‘‘documented agreement’’ to 

provide such services. 

Language that addresses drug testing 

services has been finalized to remove 

stigmatizing phrases, such as ‘‘drug 

abuse’’, and to remove content on shortterm withdrawal management 

(‘‘detoxification’’). Further to this, the 

final rule clarifies that the requirement 

to use drug tests that have received the 

Food and Drug Administration (FDA)’s 

marketing authorization is limited to 

random drug testing using samples 

obtained from patients, including urine 

or saliva. Pursuant to public comments 

on the NPRM, the final rule does not 

preclude distribution of legally 

permissible testing supplies, that check 

for adulteration of an individual’s 

personal drug supply. 

Rules that address recordkeeping and 

efforts to avoid simultaneous enrollment 

in multiple OTPs are finalized, as per 

the NPRM, 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 final 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. 

As described in the NPRM, 

specification of disciplines authorized 

to administer or dispense MOUD is 

removed from the final rule. LAAM, 

also known as Levomethadyl acetate, is 

removed from the list of treatment 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7543 

81Cartus AR, Li Y, Macmadu A, Goedel WC, 

Allen B, Cerda ́ M, Marshall BDL. Forecasted and 

Observed Drug Overdose Deaths in the US During 

the COVID–19 Pandemic in 2020. JAMA Netw 

Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/ 

jamanetworkopen.2022.3418. PMID: 35311967; 

PMCID: PMC8938716. 

82Substance Abuse and Mental Health Services 

Administration. (2022). Key substance use and 

mental health indicators in the United States: 

Results from the 2021 National Survey on Drug Use 

and Health (HHS Publication No. PEP22–07–01– 

005, NSDUH Series H–57). Center for Behavioral 

Health Statistics and Quality, Substance Abuse and 

Mental Health Services Administration. https://

www.samhsa.gov/data/report/2021-nsduh-annualnational-report. 

medications because it is no longer 

available, and other medications 

approved since prior revisions to this 

rule were added. In response to public 

comments, the regulation of an initial 

dose of methadone has been increased 

to 50mg on the first day, with the 

clarification of allowance for higher 

doses if clinically indicated, and 

documented in the patient’s record. The 

rule to ensure documentation of any 

significant deviation from FDAapproved labeling has been maintained 

in the final rule, while redundant 

language was removed. 

Rules on the provision of 

unsupervised (or take-home) doses of 

methadone are finalized, as per the 

NPRM, to incorporate flexibilities 

issued in response to the COVID–19 

pandemic. In general, the final 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 is finalized, as well 

as patient education on safe transport 

and storage of take-home doses, 

including documentation of the 

provision of this education in the 

patient’s clinical record. 

Consistent with the conditions for 

approval of interim treatment, the final 

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 rule finalizes removal 

of the requirement for observation of all 

daily doses during interim treatment. It 

also finalizes 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 is also 

finalized. 

9. Section 8.13—Revocation of 

Accreditation and Accreditation Body 

Approval 

References to an OTP as a ‘‘program’’ 

instead of a ‘‘facility’’ are finalized. 

10. Section 8.14—Suspension or 

Revocation of Certification 

Pursuant to the NPRM, this section 

finalizes the actions that SAMHSA may 

take when immediate intervention is 

necessary to protect the public’s health 

or safety. The final rule specifies the 

administrative actions available to 

SAMHSA in the event that a program 

sponsor, or any employee of an OTP 

has: been found to have engaged in 

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. 

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 

References to an OTP as a ‘‘program’’ 

instead of a ‘‘facility’’ are finalized. 

12. Subpart F—Authorization To 

Increase Patient Limit to 275 Patients 

This subpart and corresponding 

sections are removed from the final rule, 

as described in the SNPRM. 

Severability 

The Department asserts that 

provisions in this final rule are 

severable. If any provision of this rule, 

or the application thereof to any person 

or circumstance is held invalid, that 

invalidity shall not affect other 

provisions or applications of this rule 

that can be given effect without the 

invalid provision or application. 

This rule has been organized in a way 

that separates out the major provisions 

into distinct sections and subparts. 

Many of the provisions in this rule are 

independent of each other and could 

function sensibly even without certain 

other provisions being in effect. For 

example, the provisions in subparts A, 

B and C related to accreditation and 

certification are distinct from the 

Treatment Standards enumerated in 

subpart C section 8.12. Rules related to 

take-home dosing of methadone are also 

severable from other rules, such as those 

regarding telehealth and interim 

treatment. 

If any specific provision of this rule 

is found unconstitutional or invalid, the 

Department intends that the remainder 

would still operate independently. The 

Department believes that each provision 

in this rule offers a distinct benefit to 

the public, patients, and healthcare 

providers. Therefore, if any specific 

application or provision is invalidated, 

the remainder of the legally valid 

provisions should remain in effect. 

Regulatory Impact Analysis 

The Department has examined the 

impact of the final 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 final rule is being issued to 

update part 8 in response to increasing 

opioid overdose deaths, exacerbated by 

the COVID–19 pandemic.81 Across the 

United States in 2021, 9.2 million 

people aged 12 or older misused heroin 

or misused prescription pain relievers 

in the preceding twelve months.82 The 

percentage was highest among young 

adults aged 26 or older (3.5 percent or 

7.7 million people), followed by adults 

aged 18 to 25 (3.1 percent or 1 million 

people). It was lowest among 

adolescents aged 12 to 17 (1.9 percent 


khammond on DSKJM1Z7X2PROD with RULES4
7544 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

83 Kariisa M, Davis NL, Kumar S, et al. Vital 

Signs: Drug Overdose Deaths, by Selected 

Sociodemographic and Social Determinants of 

Health Characteristics—25 States and the District of 

Columbia, 2019–2020. MMWR Morb Mortal Wkly 

Rep 2022;71:940–947. DOI: http://dx.doi.org/ 

10.15585/mmwr.mm7129e2. See also https://

www.seattletimes.com/nation-world/nation/ 

addiction-treatment-medicine-is-vastlyunderprescribed-especially-by-race-study-finds/. 

84Substance Abuse and Mental Health Services 

Administration: The Opioid Crisis and the 

Hispanic-Latino 1opulatiorgent Issue. Publication 

No. PEP20–05–02–002. Office of Behavioral Health 

Equity. Substance Abuse and Mental Health 

Services Administration, 2020. https://

store.samhsa.gov/sites/default/files/pep20-05-02- 

002.pdf. 

85Larochelle MR, Bernson D, Land T, Stopka TJ, 

Wang N, Xuan Z, Bagley SM, Liebschutz JM, Walley 

AY (2018). Medication for Opioid Use Disorder 

After Nonfatal Opioid Overdose and Association 

With Mortality: A Cohort Study. Ann Intern Med. 

Aug 7;169(3):137–145. doi: 10.7326/M17–3107. 

86Winograd RP, Presnall N, Stringfellow E, Wood 

C, Horn P, Duello A, Green L, Rudder T. (2019). The 

case for a medication first approach to the treatment 

of opioid use disorder. Am J Drug Alcohol Abuse. 

2019;45(4):333–340. doi: 10.1080/ 

00952990.2019.1605372. Epub 2019 May 14. PMID: 

31084515. 

87 D’Aunno T, Pollack HA. (2002). Changes in 

methadone treatment practices: results from a 

national panel study, 1988–2000. JAMA. 

2002;288(7):850–856. doi:10.1001/jama.288.7.850. 

88Strain EC, Stitzer ML, Liebson IA, Bigelow GE. 

(1994). Comparison of buprenorphine and 

methadone in the treatment of opioid dependence. 

Am J Psychiatry. 1994 Jul;151(7):1025–30. doi: 

10.1176/ajp.151.7.1025. PMID: 8010359. 

89Mitchell P, Samsel S, Curtin KM, Price A, 

Turner D, Tramp R, Hudnall M, Parton J, Lewis D. 

(2022). Geographic disparities in access to 

Medication for Opioid Use Disorder across US 

census tracts based on treatment utilization 

behavior. Soc Sci Med. 2022 Jun;302:114992. doi: 

10.1016/j.socscimed.2022.114992. Epub 2022 Apr 

28. PMID: 35512612. 

90 Kariisa M, Davis NL, Kumar S, et al. Vital 

Signs: Drug Overdose Deaths, by Selected 

Sociodemographic and Social Determinants of 

Health Characteristics—25 States and the District of 

Columbia, 2019–2020. MMWR Morb Mortal Wkly 

Rep 2022;71:940–947. DOI: http://dx.doi.org/ 

10.15585/mmwr.mm7129e2. 

91 Krawczyk, N., Rivera, B.D., Levin, E., & 

Dooling, B.C.E. (2023). Synthesizing evidence of the 

effects of COVID–19 regulatory changes on 

methadone treatment for opioid use disorder: 

implications for policy. The Lancet. Public health, 

8(3), e238–e246. https://doi.org/10.1016/S2468- 

2667(23)00023-3. 

or 497,000 people).83 These numbers 

likely underestimate the true prevalence 

of opioid misuse and opioid use 

disorder (OUD), since the use of illicitly 

manufactured fentanyl has not to date 

been considered in the National Survey 

on Drug Use and Health (NSDUH), 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 

and 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 non-Hispanic Black, 

American Indian and Alaska Native 

communities over the course of the 

pandemic.83 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.83 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.83 It was also found that Black 

people were less than half as likely as 

white people to have received substance 

use treatment. As SAMHSA has noted, 

the Hispanic community also has been 

adversely impacted by opioid 

overdoses.84

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),85 yet few people 

who may benefit from these medications 

have immediate and sustained access to 

them.86

The pattern of enrollment in programs 

providing methadone was established in 

the latter part of the 20th century.87

Research reveals that the rate of 

methadone treatment at that time was 

highest in low-income urban areas.88

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.89

SAMHSA believes that 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; 

• Reduced stigma and discrimination 

based on changes to ensure updated 

language and terminology; 

• Clarification of standards applying 

to Accreditation Bodies; and 

• Revising Federal Opioid Use 

Disorder Treatment Standards. 

SAMHSA notes below that these 

changes are associated with limited 

burden as the final rule does not 

substantially alter reporting or 

accreditation activities. The changes 

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. 

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 final rule is partially regulatory 

and partially deregulatory. The 

Department estimates that because 

much of what has been finalized does 

not substantially alter current practice 

as implemented over the past 3 years 

under the COVID PHE, the final rule 

will not result in significantly altered 

costs. Further to this, the final 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 patientcentered care, updating accreditation 

procedures and providing a stable 

regulatory environment. Additionally, 

the final rule makes permanent some 

OTP treatment flexibilities implemented 

within the past three 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.90 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.91 Black youth ages 15 to 

24 saw an 86 percent increase in 

overdose deaths, the largest spike of any 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7545 

92Luo, F., Li, M., & Florence, C. (2021). StateLevel Economic Costs of Opioid Use Disorder and 

Fatal Opioid Overdose—United States, 2017. 

MMWR. Morbidity and mortality weekly report, 

70(15), 541–546. https://doi.org/10.15585/ 

mmwr.mm7015a1. See also https://

trumpwhitehouse.archives.gov/briefingsstatements/cea-report-underestimated-cost-opioidcrisis/ citing a Council of Economic Advisors study 

estimating 2015 costs at $504 billion and a 

Congressional study using the CDC methodology 

estimating 2020 opioid crisis costs as $1.5 trillion. 

See https://beyer.house.gov/news/ 

documentsingle.aspx. 

93Mitchell, S.G., Gryczynski, J., Schwartz, R.P., 

Myers, C.P., O’Grady, K.E., Olsen, Y.K., & Jaffe, J.H. 

(2015). Changes in Quality of Life following 

Buprenorphine Treatment: Relationship with 

Treatment Retention and Illicit Opioid Use. Journal 

of psychoactive drugs, 47(2), 149–157. https://

doi.org/10.1080/02791072.2015.1014948. 

94Fairley M, Humphreys K, Joyce VR, et al. 

(2021). Cost-effectiveness of Treatments for Opioid 

Use Disorder. JAMA Psychiatry. 2021;78(7):767– 

777. doi:10.1001/jamapsychiatry.2021.0247. 

95McAdam-Marx C, Roland CL, Cleveland J, 

Oderda GM (2010). Costs of opioid abuse and 

misuse determined from a Medicaid database. J 

Pain Palliat Care Pharmacother. 2010 Mar;24(1):5– 

18. doi: 10.3109/15360280903544877. PMID: 

20345194. 

96Murphy SM, Polsky D (2016). Economic 

Evaluations of Opioid Use Disorder Interventions. 

Pharmacoeconomics. 2016 Sep;34(9):863–87. doi: 

10.1007/s40273–016–0400–5. PMID: 27002518; 

PMCID: PMC5572804. 

97Baser O, Chalk M, Fiellin DA, Gastfriend DR 

(2011). Cost and utilization outcomes of opioiddependence treatments. Am J Manag Care. 2011 

Jun;17 Suppl 8:S235–48. PMID: 21761950. 

98Lynch FL, McCarty D, Mertens J, Perrin NA, 

Green CA, Parthasarathy S, Dickerson JF, Anderson 

BM, Pating D (2014). Costs of care for persons with 

opioid dependence in commercial integrated health 

systems. Addict Sci Clin Pract. 2014 Aug 14;9(1):16. 

doi: 10.1186/1940–0640–9–16. PMID: 25123823; 

PMCID: PMC4142137. 

99Hsu, Y.J., Marsteller, J.A., Kachur, S.G., & 

Fingerhood, M.I. (2019). Integration of 

Buprenorphine Treatment with Primary Care: 

Comparative Effectiveness on Retention, 

Utilization, and Cost. Population health 

management, 22(4), 292–299. https://doi.org/ 

10.1089/pop.2018.0163. 

100Mohlman MK, Tanzman B, Finison K, Pinette 

M, Jones C. Impact of Medication-Assisted 

Treatment for Opioid Addiction on Medicaid 

Expenditures and Health Services Utilization Rates 

in Vermont. J Subst Abuse Treat. 2016 Aug; 67:9– 

14. doi: 10.1016/j.jsat.2016.05.002. Epub 2016 May 

9. PMID: 27296656. 

age or race group, while Black men 65 

and older were nearly seven times as 

likely than white men to die from an 

overdose.90 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 patientcentered care that is culturally 

appropriate and responsive to patient 

need, while also fostering a treatment 

environment that promotes and sustains 

patient engagement. The final rule 

facilitates 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 final rule promotes 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 final rule also facilitates 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 

three years demonstrates safety, as well 

as high patient and practitioner 

satisfaction with take-home doses of 

methadone.91 This is principally 

because take-home doses of methadone 

allow individuals the opportunity to 

engage in employment, education and 

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.92 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.93

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.94 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%).95

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. $8,436; P 

<0.001).95 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.96 97 98 For 

example, a 2019 analysis demonstrated 

that a comprehensive approach to OUD 

treatment is associated with improved 

health and economic outcomes.99 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$1,448 vs. $4,265, P = 0.001).100

Other measures, including emergency 

department utilization and cost, 

substance use-related cost, and nonbuprenorphine 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 


khammond on DSKJM1Z7X2PROD with RULES4
7546 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

101McCarty D, Perrin NA, Green CA, Polen MR, 

Leo MC, Lynch F (2010). Methadone maintenance 

and the cost and utilization of health care among 

individuals dependent on opioids in a commercial 

health plan. Drug Alcohol Depend. 2010 Oct 

1;111(3):235–40. doi: 10.1016/ 

j.drugalcdep.2010.04.018. PMID: 20627427; PMCID: 

PMC2950212. 

102Baser O, Chalk M, Fiellin DA, Gastfriend DR. 

(2011). Cost and utilization outcomes of opioiddependence treatments. Am J Manag Care. 2011 

Jun;17 Suppl 8:S235–48. PMID: 21761950. 

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.100

Two prior studies assessed data from 

commercial health insurance claims on 

the overall health care costs and 

utilization rates for those taking MOUD 

compared to those treated without 

MOUD.101 102 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.101 The other study found 

that after a six-month period, those 

taking MOUD had significantly lower 

overall annual health plan costs 

compared to those with no medication 

($10,192 vs. $14,353; p-value < 

0.0001).102 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 rule does not substantially alter 

current reporting burden requirements, 

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. 

b. Estimated Costs of Reporting Burdens 

for OTPs and Accreditation Bodies 

In developing its estimates of the 

potential costs of the final 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. 

Items 

Preparation 

time 

(hours) 

Cost/hour Total cost 

Form SMA–163, compliance with the reporting requirements under 42 CFR 8.4 and 8.6 ........ 394.2 $85.42 $33,672.56 

Form SMA–162, compliance with other reporting requirements under 21 CFR 8.11, 8.24, 

8.25, 8.26, and 8.28 ................................................................................................................. 188.95 85.42 16,140.11 

Form SMA–168, Exception Request and Record of Justification Under 42 CFR 8.11(h) .......... 2,135 85.42 182,371.70 

Sub total ............................................................................................................................... ........................ ........................ $232,184.37 

c. Cost Pertaining to Record Keeping 

The record-keeping 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 or a cost 

burden for these activities, nor did 

commenters provide such information. 

Costs Pertaining to Disclosure 

The final 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. 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7547 

e. Estimate of Annualized Non-Hourly 

Cost Burden to Respondents 

The final 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 2,000 affected OTPs 

these total annual costs are estimated to 

be $30,752,000. The percentage of this 

total cost that is associated with record 

keeping 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 protected website for 

day-to-day regulatory activities that can 

be used by SAMSHA, opioid treatment 

programs, State Opioid Treatment 

Authorities, Accreditation Bodies and 

other stakeholders. This estimate does 

not include funds that SAMHSA/Center 

for Substance Abuse Treatment (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. 

ANNUALIZED COST TO SAMHSA/CSAT 

Item 

(purpose) Responses Hours per response 

Total 

hours 

Total cost@ 

$85.42 per 

hour 

SMA–162 (New Programs) .............................................................................. 42 1.5 63 $5,381 

SMA–162 (Renewal) ........................................................................................ 386 .75 289.5 24,729 

SMA–162 (Relocation) ..................................................................................... 35 .25 8.75 747 

Notification of Provisional Certification ............................................................ 40 .50 20 1,708 

Notification of Extension of Provisional Certification ....................................... 15 .50 7.5 641 

Notification of Sponsor or Medical Director Change ....................................... 60 0.33 19.8 1,691 

Documentation to SAMHSA for Interim Treatment ......................................... 1 0.50 0.5 43 

Requests to SAMHSA for Exemption from §§ 8.11 and 8.12 (including 

SMA–168) .................................................................................................... 24,000 0.07 1680 143,506 

Notification to SAMHSA Before Establishing Medication Units ...................... 20 1.00 20 1,708 

Review of Submissions under Part C .............................................................. 2 2.00 4 342 

Accreditation Body Initial Application (SMA–163) ........................................... 3 40 120 10,250 

Accreditation Body Renewal (SMA–163) ........................................................ 3 40 120 10,250 

Relinquishment Notification ............................................................................. 1 .50 0.5 43 

Notification for Serious Non-Compliant Programs ........................................... 2 .50 1 85 

General Documents to SAMHSA Upon Request ............................................ 10 1.00 10 854 

Accreditation Survey to SAMHSA Upon Request ........................................... 383 .50 191.5 16,358 

Less Than Full Accreditation Report to SAMHSA ........................................... 10 1.00 10 854 

Summaries of Inspections ............................................................................... 12 1.00 12 1,025 

Notification of Complaints to SAMHSA ........................................................... 10 1.00 10 854 

Submission of 90-Day Corrective Plan to SAMHSA ....................................... 1 4.25 4.25 363 

Sub total ................................................................................................... 25,03625,036 97.15 2592.3 221,434 

2. Consideration of Regulatory 

Alternatives 

The Department has completed 

rulemaking to make flexibilities issued 

during the COVID–19 PHE permanent, 

while also updating accreditation and 

treatment standards to reflect evidencebased 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. This is considered to be 

suboptimal as it creates uncertainty 

among patients and OTPs, while also 

constraining access to care. Rulemaking, 

on the other hand, allows OTPs and 

their patients to operate in a stable and 

regulated environment that promotes 

access to evidence-based interventions. 

Other changes in the rule impact 

Accreditation Body oversight and 

procedures. Such changes can only be 

effectuated in a regulatory setting. 

B. Regulatory Flexibility Act 

The Department has examined the 

economic implications of this final 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. 

Pursuant to the RFA (5 U.S.C. 601– 

612), the Department asserts a factual 

basis for its certification that the rule 

will not have a significant economic 

impact on a substantial number of small 

entities. As discussed in the Regulatory 


khammond on DSKJM1Z7X2PROD with RULES4
7548 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

103Public Law 105–277, 112 Stat. 2681 (October 

21, 1998). 

Impact Analysis (RIA) the costs 

associated with compliance are 

minimal. As such, the Department 

certifies that the proposed rule will not 

impose a significant economic impact. 

The RIA contains the factual details 

supporting this certification, affirming 

the conclusion that the financial impact 

of compliance is insubstantial in 

relation to the affected entities’ financial 

operations. 

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 

2023, this threshold is $165 million. 

The Department does not anticipate that 

this final 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 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 103 requires Federal 

departments and agencies to determine 

whether a 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 final 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 rule. 

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 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 

sought public comment on its 

assumptions as they relate to the PRA 

requirements summarized in this 

section. No applicable comments were 

received. 

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 OTPs 

pursuant to the final rule. 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES

42 CFR citation Purpose Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Hours/ 

response 

Total 

hours 

8.3(b)(1) through (11) .. Initial approval (SMA–163) ........ 1 1 1 6.0 6 

8.3(c) ........................... Renewal of approval (SMA–163) 2 1 2 1.0 2 

8.3(e) ........................... Relinquishment notification ........ 1 1 1 0.5 0.5 

8.3(f)(2) ........................ Non-renewal notification to accredited OTPs.1 90 90 0.1 9 

8.4(b)(1)(ii) ................... Notification to SAMHSA for seriously noncompliant OTPs.2 2 4 1.0 4 

8.4(b)(1)(iii) .................. Notification to OTP for serious 

noncompliance.

2 10 20 1.0 20 

8.4(d)(1) ....................... General documents and information to SAMHSA upon request.6 5 30 0.5 15 

8.4(d)(2) ....................... Accreditation survey to 

SAMHSA upon request.

6 75 450 0.02 9 

8.4(d)(3) ....................... List of surveys, surveyors to 

SAMHSA upon request.

6 6 36 0.2 7.2 

8.4(d)(4) ....................... Report of less than full accreditation to SAMHSA.6 5 30 0.5 15 

8.4(d)(5) ....................... Summaries of Inspections ......... 6 50 300 0.5 150 

8.4(e) ........................... Notifications of Complaints ........ 12 6 72 0.5 36 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7549 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES—Continued 

42 CFR citation Purpose Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Hours/ 

response 

Total 

hours 

8.6(a)(2) and (b)(3) ...... Revocation notification to Accredited OTPs.1 185 185 0.3 55.5 

8.6(b) ........................... Submission of 90-day corrective 

plan to SAMHSA.

1 1 1 10 10.0 

8.6(b)(1) ....................... Notification to accredited OTPs 

of Probationary Status.

1 185 185 0.3 55.5 

Sub total ............... .................................................... 54 ........................ 1,407 ........................ 394.70 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS

42 CFR citation Purpose Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Hours/ 

response 

Total 

hours 

8.11(b) ......................... Renewal of approval (SMA–162) 386 1 386 0.15 57.9 

8.11(b) ......................... Relocation of Program (SMA– 

162).

35 1 35 1.17 40.95 

8.11(d) ......................... Application for provisional certification.42 1 42 1 42.00 

8.11(f) .......................... Application for extension of provisional certification.30 1 30 0.25 7.50 

8.11(g)(5) ..................... Notification of sponsor or medical director change (SMA– 

162).

60 1 60 0.1 6.00 

8.11(h)(2) ..................... Documentation to SAMHSA for 

interim treatment.

1 1 1 1 1.00 

8.11(i) .......................... Request to SAMHSA for Exemption from §§ 8.11 and 

8.12 (including SMA–168).

1,200 20 24,000 0.07 1,680 

8.11(j)(1) ...................... Notification to SAMHSA Before 

Establishing Medication Units 

(SMA–162).

10 1 10 0.25 2.5 

8.12(j)(2) ...................... Notification to State Opioid 

Treatment Authority For Interim Treatment.

1 20 20 0.33 6.6 

8.24 .............................. Contents of Appellant Request 

for Review of Suspension.

2 1 2 0.25 .50 

8.25(a) ......................... Informal Review Request ........... 2 1 2 1.00 2.00 

8.26(a) ......................... Appellant’s Review File and 

Written Statement.

2 1 2 5.00 10.00 

8.28(a) ......................... Appellant’s Request for Expedited Review.2 1 2 1.00 2.00 

8.28(c) ......................... Appellant Review File and Written Statement.2 1 2 5.00 10.00 

Sub total ............... .................................................... 1,775 ........................ 24,594 ........................ 1,868.95 

Total .............. .................................................... 1,829 ........................ 26,001 ........................ 2,263.65 

The tables above reflect current 

estimates of burden, as the final 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 eighteen months. Further to 

this, the estimates of burden do not 

substantially differ from previously 

submitted estimates provided to The 

Office of Management and Budget. 

Recognizing the importance of 

expanding access to care, the 

Department has been careful to limit 

additional burden. 

The final 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 final 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 

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 


khammond on DSKJM1Z7X2PROD with RULES4
7550 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

Services revises 42 CFR part 8 to read 

as set forth below: 

PART 8—MEDICATIONS FOR THE 

TREATMENT OF OPIOID USE 

DISORDER 

Subpart A—General Provisions 

Sec. 

8.1 Scope. 

8.2 Definitions. 

Subpart B—Accreditation of Opioid 

Treatment Programs 

8.3 Application for approval as an 

Accreditation Body. 

8.4 Accreditation Body responsibilities. 

8.5 Periodic evaluation of Accreditation 

Bodies. 

8.6 Withdrawal of approval of 

Accreditation Bodies. 

Subpart C—Certification and Treatment 

Standards for Opioid Treatment Programs 

8.11 Opioid Treatment Program 

certification. 

8.12 Federal Opioid Use Disorder treatment 

standards. 

8.13 Revocation of accreditation and 

Accreditation Body approval. 

8.14 Suspension or revocation of 

certification. 

8.15 Forms. 

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 

8.21 Applicability. 

8.22 Definitions. 

8.23 Limitation on issues subject to review. 

8.24 Specifying who represents the parties. 

8.25 Informal review and the reviewing 

official’s response. 

8.26 Preparation of the review file and 

written arguments. 

8.27 Opportunity for oral presentation. 

8.28 Expedited procedures for review of 

immediate suspension. 

8.29 Ex parte communications. 

8.30 Transmission of written 

communications by reviewing official 

and calculation of deadlines. 

8.31 Authority and responsibilities of the 

reviewing official. 

8.32 Administrative record. 

8.33 Written decision. 

8.34 Court review of final administrative 

action; exhaustion of administrative 

remedies. 

Subpart E [Reserved] 

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 

§ 8.1 Scope. 

(a) Scope. This subpart and subparts 

B through D of this part establish the 

procedures by which the Secretary of 

Health and Human Services (the 

Secretary) will determine whether an 

applicant seeking to become an Opioid 

Treatment Program (OTP) is qualified 

under section 303(h) of the Controlled 

Substances Act (CSA) (21 U.S.C. 823(h)) 

to dispense Medications for Opioid Use 

Disorder (MOUD) in the treatment of 

Opioid Use Disorder (OUD), and 

establishes the Secretary’s standards 

regarding the appropriate quantities of 

MOUD that may be provided for 

unsupervised use by individuals 

undergoing such treatment (21 U.S.C. 

823(h)). Under this subpart and subparts 

B through D, an applicant seeking to 

become an OTP must first obtain from 

the Secretary or, by delegation, from the 

Assistant Secretary for Mental Health 

and Substance Use, a certification that 

the applicant is qualified under the 

Secretary’s standards and will comply 

with such standards. Eligibility for 

certification will depend upon the 

applicant obtaining accreditation from 

an Accreditation Body that has been 

approved by the Secretary. This subpart 

and subparts B through D also establish 

the procedures whereby an entity can 

apply to become an approved 

Accreditation Body, and the 

requirements and general standards for 

Accreditation Bodies to ensure that 

OTPs are consistently evaluated for 

compliance with the Secretary’s 

standards for treatment of OUD with 

MOUD. 

(b) Severability. Any provision of this 

part held to be invalid or unenforceable 

by its terms, or as applied to any person 

or circumstance, or stayed pending 

further agency action, shall be construed 

so as to give it the maximum effect 

permitted by law, unless such holding 

shall be one of utter invalidity or 

unenforceability, in which event such 

provision shall be severable from this 

part and shall not affect the remainder 

thereof or the application of the 

provision to persons not similarly 

situated or to dissimilar circumstances. 

§thnsp;8.2 Definitions. 

The following definitions apply to 

this part: 

Accreditation Body or ‘‘the Body’’ 

means an organization that has been 

approved by the Secretary in this part to 

accredit OTPs dispensing MOUD. 

Accreditation Body application means 

the application filed with the Secretary 

for purposes of obtaining approval as an 

Accreditation Body, as described in 

§ 8.3(b). 

Accreditation elements mean the 

elements or standards that are 

developed and adopted by an 

Accreditation Body and approved by the 

Secretary. 

Accreditation survey means an onsite 

or virtual review and evaluation of an 

OTP by an Accreditation Body for the 

purpose of determining compliance 

with the Federal opioid use disorder 

treatment standards described in § 8.12. 

Accredited OTP means an OTP that is 

the subject of a current, valid 

accreditation from an Accreditation 

Body approved by the Secretary under 

§ 8.3(d). 

Behavioral health services means any 

intervention carried out in a therapeutic 

context at an individual, family, or 

group level. Interventions may include 

structured, professionally administered 

clinical interventions (e.g., cognitive 

behavior therapy or insight-oriented 

psychotherapy) delivered in-person, or 

remotely via telehealth or telemedicine, 

which has been shown to facilitate 

treatment outcomes, or non-clinical 

interventions. 

Care plan means an individualized 

treatment and/or recovery plan that 

outlines attainable treatment goals that 

have been identified and agreed upon 

between the patient and the OTP 

clinical team, and which specifies the 

services to be provided, as well as the 

proposed frequency and schedule for 

their provision. 

Certification means the process by 

which the Secretary determines that an 

OTP is qualified to provide OUD 

treatment under the Federal Opioid Use 

Disorder treatment standards. 

Certification application means the 

application filed by an OTP for 

purposes of obtaining certification from 

the Secretary, as described in § 8.11(b). 

Certified opioid treatment program 

means an OTP that is the subject of a 

current, valid certification under § 8.11. 

Comprehensive treatment is treatment 

that includes the continued use of 

MOUD provided in conjunction with an 

individualized range of appropriate 

harm reduction, medical, behavioral 

health, and recovery support services. 

Conditional certification is a type of 

temporary certification granted to an 

OTP that has requested renewal of its 

certification and that has received 

temporary accreditation for one year by 

an approved Accreditation Body. The 

one-year accreditation period is to allow 

the OTP to address areas of significant 

non-conformance with accreditation 

standards that do not involve 

immediate, high-risk health and/or 

safety concerns. 

Continuous medication treatment 

means the uninterrupted treatment for 

OUD involving the dispensing and 

administration of MOUD at stable 

dosage levels for a period in excess of 

21 days. 

Dispense means to deliver a 

controlled medication to an ultimate 

user by, or pursuant to, the lawful order 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7551 

of, a practitioner, including the 

prescribing and administering of a 

controlled medication. 

Diversion control plan means a set of 

documented procedures that reduce the 

possibility that controlled medications 

will be transferred or otherwise shared 

with others to whom the medication 

was not prescribed or dispensed. 

Federal Opioid Use Disorder 

treatment standards means the 

standards established by the Secretary 

in § 8.12 that are used to determine 

whether an OTP is qualified to engage 

in OUD treatment. The Federal Opioid 

Use Disorder treatment standards 

established in § 8.12 also include the 

standards established by the Secretary 

regarding the quantities of MOUD 

which may be provided for 

unsupervised, take-home use. 

For-cause inspection means an 

inspection, by the Secretary, an 

Accreditation Body, or a State authority, 

of an OTP that may be operating in 

violation of Federal Opioid Use 

Disorder treatment standards, may be 

providing substandard treatment, may 

be serving as a possible source of 

diverted medications, or where patient 

well-being is at risk. 

Harm reduction refers to practical and 

legal evidence-based strategies, 

including: overdose education; testing 

and intervention for infectious diseases, 

including counseling and risk 

mitigation activities forming part of a 

comprehensive, integrated approach to 

address human immunodeficiency virus 

(HIV), viral hepatitis, sexually 

transmitted infections, and bacterial and 

fungal infections; distribution of opioid 

overdose reversal medications; linkage 

to other public health services; and 

connecting those who have expressed 

interest in additional support to peer 

services. 

Individualized dose means the dose of 

a medication for opioid use disorder, 

ordered by an OTP practitioner and 

dispensed to a patient, that sufficiently 

suppresses opioid withdrawal 

symptoms. Individualized doses may 

also include split doses of a medication 

for opioid use disorder, where such 

dosing regimens are indicated. 

Interim treatment means that on a 

temporary basis, a patient may receive 

some services from an OTP, while 

awaiting access to more comprehensive 

treatment services. The duration of 

interim treatment is limited to 180 days. 

Long-term care facilities mean those 

facilities that provide rehabilitative, 

restorative, and/or ongoing services to 

those in need of assistance with 

activities of daily living. Long-term care 

facilities include: extended acute care 

facilities; rehabilitation centers; skilled 

nursing facilities; permanent supportive 

housing; assisted living facilities; and 

chronic care hospitals. 

Medical director means a physician, 

licensed to practice medicine in the 

jurisdiction in which the OTP is 

located, who assumes responsibility for 

all medical and behavioral health 

services provided by the program, 

including their administration. A 

medical director may delegate specific 

responsibilities to authorized program 

physicians, appropriately licensed nonphysician practitioners with 

prescriptive authority functioning under 

the medical director’s supervision, or 

appropriately licensed and/or 

credentialed non-physician healthcare 

professionals providing services in the 

OTP, in compliance with applicable 

Federal and State laws. Such 

delegations will not eliminate the 

medical director’s responsibility for all 

medical and behavioral health services 

provided by the OTP. 

Medication for Opioid Use Disorder or 

MOUD means medications, including 

opioid agonist medications, approved 

by the Food and Drug Administration 

under section 505 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355), 

for use in the treatment of OUD. As used 

in this part, ‘‘continuous medication 

treatment’’ is intended to be 

synonymous with the term 

‘‘maintenance’’ treatment as used in 21 

U.S.C. 823(h)(1), and the term 

‘‘withdrawal management’’ is intended 

to be synonymous with the term 

‘‘detoxification’’ as used in 21 U.S.C. 

823(h)(1). 

Medication unit means an entity that 

is established as part of, but 

geographically separate from, an OTP 

from which appropriately licensed OTP 

practitioners, contractors working on 

behalf of the OTP, or community 

pharmacists may dispense or administer 

MOUD, collect samples for drug testing 

or analysis, or provide other OTP 

services. Medication units can be a 

brick-and-mortar location or mobile 

unit. 

Nationally recognized evidence-based 

guidelines mean a document produced 

by a national or international medical 

professional association, public health 

agency, such as the World Health 

Organization, or governmental body 

with the aim of assuring the appropriate 

use of evidence to guide individual 

diagnostic and therapeutic clinical 

decisions for the management of OUD 

and other health conditions that are 

widely recognized within the United 

States. 

Opioid Treatment Program or OTP 

means a program engaged in OUD 

treatment of individuals with MOUD 

registered under 21 U.S.C. 823(h)(1). 

Opioid Treatment Program 

certification means the process by 

which the Secretary determines that an 

OTP applicant is qualified to provide 

Opioid Use Disorder treatment under 

the Federal Opioid Use Disorder 

treatment standards described in § 8.12. 

Opioid Use Disorder means a cluster 

of cognitive, behavioral, and 

physiological symptoms associated with 

a problematic pattern of opioid use that 

continues despite clinically significant 

impairment or distress within a 12- 

month period. 

Opioid Use Disorder treatment means 

the dispensing of MOUD, along with the 

provision of a range of medical and 

behavioral health services, as clinically 

necessary and based on an 

individualized assessment and a 

mutually agreed-upon care plan, to an 

individual to alleviate the combination 

of adverse medical, psychological, or 

physical effects associated with an 

OUD. 

Patient, for purposes of this part, 

means any individual who receives 

continuous treatment or withdrawal 

management in an OTP. 

Physical and behavioral health 

services include services such as 

medical and psychiatric screening, 

assessments, evaluations, examinations, 

and interventions, counseling, health 

education, peer support services, and 

social services (e.g., vocational and 

educational guidance, employment 

training), that are intended to help 

patients receiving care in OTPs achieve 

and sustain remission and recovery. 

Practitioner, for purposes of this part, 

means a health care professional who is 

appropriately licensed by a State to 

prescribe and/or dispense medications 

for opioid use disorders and, as a result, 

is authorized to practice within an OTP. 

Program sponsor means the person 

named in the application for 

certification described in § 8.11(b) as 

responsible for the operation of the OTP 

and who assumes responsibility for all 

its employees, including any 

practitioners, agents, or other persons 

providing medical, behavioral health, or 

social services at the program or any of 

its medication units. The program 

sponsor need not be a licensed 

physician but shall ensure that an 

actively licensed physician occupies the 

position of medical director within an 

OTP. 

Recovery support services means: 

(1) Recovery is the process of change 

through which people improve their 

health and wellness, live self-directed 

lives, and strive to reach their full 

potential. 


khammond on DSKJM1Z7X2PROD with RULES4
7552 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

(2) Recovery support services can 

include, but are not limited to, 

community-based recovery housing, 

peer recovery support services, social 

support, linkage to and coordination 

among allied service providers and a 

full range of human services that 

facilitate recovery and wellness 

contributing to an improved quality of 

life. The services extend the continuum 

of care by strengthening and 

complementing substance use disorder 

(SUD) treatment interventions in 

different settings and stages. 

Split dosing means dispensing of a 

single dose of MOUD as separate 

portions to be taken within a 24-hour 

period. Split dosing is indicated among, 

but not limited to, those patients who: 

possess a genetic variant which 

increases methadone metabolism; 

concurrently take other medications or 

drink alcohol that also induce hepatic 

enzymes leading to more rapid 

metabolism of methadone; who are 

pregnant; or for whom methadone or 

buprenorphine are being used to treat a 

concurrent pain indication in addition 

to the diagnosis of OUD. This leads to 

more stable, steady-state medication 

levels. 

State Opioid Treatment Authority 

(SOTA) is the agency designated by the 

Governor of a State, or other appropriate 

official designated by the Governor, to 

exercise the responsibility and authority 

within the State or Territory for 

governing the treatment of OUD with 

MOUD in OTPs. 

Telehealth or telemedicine, for 

purposes of this part, is the delivery and 

facilitation of health and health-related 

services including medical care, 

counseling, practitioner, provider and 

patient education, health information 

services, and self-care via 

telecommunications and digital 

communication technologies. This 

includes Health Insurance Portability 

and Accountability Act (HIPAA)- 

compliant video and audio-only 

communication platforms. 

Withdrawal management means the 

dispensing of a MOUD in decreasing 

doses to an individual to alleviate 

adverse physical effects incident to 

withdrawal from the continuous or 

sustained use of an opioid and as a 

method of bringing the individual to an 

opioid-free state within such period. 

Long-term withdrawal management 

refers to the process of medication 

tapering that exceeds 30 days. 

Subpart B—Accreditation of Opioid 

Treatment Programs 

§ 8.3 Application for approval as an 

Accreditation Body. 

(a) Eligibility. Private nonprofit 

organizations, State or territorial 

governmental entities, or political 

subdivisions thereof, and Indian Tribes 

as defined by the Federally Recognized 

Indian Tribe List Act of 1994, that are 

capable of meeting the requirements of 

this part may apply for approval as an 

Accreditation Body. 

(b) Application for initial approval. 

Electronic copies of an Accreditation 

Body application form [SMA–167] shall 

be submitted to: https://

dpt2.samhsa.gov/sma163/. 

Accreditation Body applications shall 

include the following information and 

supporting documentation: 

(1) Name, address, and telephone 

number of the applicant and a 

responsible official for the Accreditation 

Body. The application shall be signed 

by the responsible official; 

(2) Evidence of the nonprofit status of 

the applicant (i.e., of fulfilling Internal 

Revenue Service requirements as a 

nonprofit organization) if the applicant 

is not a State or territorial governmental 

entity, Indian Tribe, or political 

subdivision; 

(3) A set of the accreditation elements 

or standards and a detailed discussion 

showing how the proposed 

accreditation elements or standards will 

ensure that each OTP surveyed by the 

applicant is qualified to meet or is 

meeting each of the Federal opioid use 

disorder treatment standards set forth in 

§ 8.12; 

(4) A detailed description of the 

applicant’s decision-making process, 

including: 

(i) Procedures for initiating and 

performing onsite accreditation surveys 

of OTPs; 

(ii) Procedures for assessing OTP 

personnel qualifications; 

(iii) Copies of an application for 

accreditation, guidelines, instructions, 

and other materials the applicant will 

send to OTPs during the accreditation 

process, including a request for a 

complete history of prior accreditation 

activities and a statement that all 

information and data submitted in the 

application for accreditation is true and 

accurate, and that no material fact has 

been omitted; 

(iv) Policies and procedures for 

notifying OTPs and the Secretary of 

deficiencies, for monitoring corrections 

of deficiencies by OTPs and for 

reporting corrections to the Secretary; 

(v) Policies and procedures for 

determining OTPs level of adherence to 

this part and Accrediting Body 

standards and level of accreditation; 

(vi) Policies and procedures for 

suspending or revoking an OTP’s 

accreditation; 

(vii) Policies and procedures that will 

ensure processing of applications for 

accreditation and applications for 

renewal of accreditation within a 

timeframe approved by the Secretary; 

and 

(viii) A description of the applicant’s 

appeals process to allow OTPs to 

contest adverse accreditation decisions; 

(5) Policies and procedures 

established by the Accreditation Body to 

avoid conflicts of interest, or the 

appearance of conflicts of interest, by 

the applicant’s board members, 

commissioners, professional personnel, 

consultants, administrative personnel, 

and other representatives; 

(6) A description of the education, 

experience, and training requirements 

for the applicant’s professional staff, 

accreditation survey team membership, 

and the identification of at least one 

licensed physician with experience 

treating OUD with MOUD on the 

applicant’s staff; 

(7) A description of the applicant’s 

survey team training policies; 

(8) Fee schedules, with supporting 

cost data; 

(9) Satisfactory assurances that the 

Body will comply with the requirements 

of § 8.4, including a contingency plan 

for investigating complaints under 

§ 8.4(e); 

(10) Policies and procedures 

established to protect confidential 

information the applicant will collect or 

receive in its role as an Accreditation 

Body; and 

(11) Any other supporting information 

the Secretary may require. 

(c) Application for renewal of 

approval. An Accreditation Body that 

intends to continue to serve as an 

Accreditation Body beyond its current 

term shall apply to the Secretary for 

renewal, or notify the Secretary of its 

intention not to apply for renewal, in 

accordance with the following 

procedures and schedule: 

(1) At least 9 months before the date 

of expiration of an Accreditation Body’s 

term of approval, the Body shall inform 

the Secretary in writing of its intent to 

seek renewal. 

(2) The Secretary will notify the 

applicant of the relevant information, 

materials, and supporting 

documentation required under 

paragraph (b) of this section that the 

applicant shall submit as part of the 

renewal procedure. 

(3) At least 3 months before the date 

of expiration of the Accreditation 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7553 

Body’s term of approval, the applicant 

shall send to the Secretary electronically 

a renewal application containing the 

information, materials, and supporting 

documentation requested by the 

Secretary under paragraph (c)(2) of this 

section. 

(4) An Accreditation Body that does 

not intend to renew its approval shall so 

notify the Secretary at least 9 months 

before the expiration of the Body’s term 

of approval. 

(d) Rulings on applications for initial 

approval or renewal of approval. (1) The 

Secretary will grant an application for 

initial approval or an application for 

renewal of approval if it determines the 

applicant substantially meets the 

Accreditation Body requirements of this 

subpart. 

(2) If the Secretary determines that the 

applicant does not substantially meet 

the requirements set forth in this 

subpart, the Secretary will notify the 

applicant of the deficiencies in the 

application and request that the 

applicant resolve such deficiencies 

within 90 days of receipt of the notice. 

If the deficiencies are resolved to the 

satisfaction of the Secretary within the 

90-day time period, the Body will be 

approved as an Accreditation Body. If 

the deficiencies have not been resolved 

to the satisfaction of the Secretary 

within the 90-day time period, the 

application for approval as an 

Accreditation Body will be denied. 

(3) If the Secretary does not reach a 

final decision on a renewal application 

before the expiration of an Accreditation 

Body’s term of approval, the approval 

will be deemed extended until the 

Secretary reaches a final decision, 

unless an Accreditation Body does not 

rectify deficiencies in the application 

within the specified time period, as 

required in paragraph (d)(2) of this 

section. 

(e) Relinquishment of approval. An 

Accreditation Body that intends to 

relinquish its accreditation approval 

before expiration of the Body’s term of 

approval shall submit a letter of such 

intent to the Secretary, at the address in 

paragraph (b) of this section, at least 9 

months before relinquishing such 

approval. 

(f) Notification. An Accreditation 

Body that does not apply for renewal of 

approval, or is denied such approval by 

the Secretary, relinquishes its 

accreditation approval before expiration 

of its term of approval, or has its 

approval withdrawn, shall: 

(1) Transfer copies of records and 

other related information as required by 

the Secretary to a location, including 

another Accreditation Body, and 

according to a schedule approved by the 

Secretary; and 

(2) Notify, in a manner and time 

period approved by the Secretary, all 

OTPs accredited or seeking 

accreditation by the Body that the Body 

will no longer have approval to provide 

accreditation services. 

(g) Term of approval. An 

Accreditation Body’s term of approval is 

for a period not to exceed 5 years. 

(h) State, territorial, or Indian Tribe 

Accreditation Bodies. State, territorial, 

and Indian Tribe entities, including 

political subdivisions thereof, may 

establish organizational units that may 

act as Accreditation Bodies, provided 

such units meet the requirements of this 

section, are approved by the Secretary 

under this section, and have taken 

appropriate measures to prevent actual 

or apparent conflicts of interest, 

including cases in which State or 

Federal funds are used to support 

MOUD. 

§ 8.4 Accreditation Body responsibilities. 

(a) Accreditation surveys and for 

cause inspections. (1) Accreditation 

Bodies shall conduct routine 

accreditation surveys for initial 

accreditation, and then at least every 

three years to allow for renewal of 

certification. 

(2) Accreditation Bodies must agree to 

conduct for-cause inspections upon the 

request of the Secretary. 

(3) Accreditation decisions shall be 

fully consistent with the policies and 

procedures submitted as part of the 

approved Accreditation Body 

application. 

(b) Response to noncompliant 

programs. (1) If an Accreditation Body 

receives or discovers information that 

suggests that an OTP is not meeting 

applicable accreditation or certification 

standards established or authorized 

under this part, or if a survey of the OTP 

by the Accreditation Body demonstrates 

that such standards are not being met, 

the Accreditation Body shall, within 60 

days following discovery of the noncompliant condition(s) or applicable 

survey date: 

(i) Provide written notice to the OTP 

that identifies each area of noncompliance, categorizes each noncompliant condition as either ‘‘minor’’ 

or ‘‘significant’’ as determined by the 

Accrediting Body, and requires the OTP 

to take corrective action to address the 

area(s) of non-compliance within a 

schedule, not to exceed 180 days, that 

the Accrediting Body deems appropriate 

based on the severity of the noncompliant conditions; and 

(ii) Provide the Secretary with a copy 

of the written notice required under 

paragraph (b)(1)(i) of this section. 

(2) Once an Accreditation Body 

provides an OTP with the notice 

described in paragraph (b)(1)(i) of this 

section, it shall verify the 

implementation of the corrective 

measures by the OTP within the 

specified schedule. Within 30 days 

following the last day of the specified 

schedule, the Accreditation Body shall 

provide written notice to the Secretary 

regarding whether the OTP has 

implemented the corrective measures. 

(3) OTPs that are meeting the 

requirements of § 8.12, but are only 

required to correct minor non-compliant 

conditions shall be granted a three-year 

accreditation, beginning from the end 

date of the current and expiring 

accreditation period. Minor noncompliant conditions, found at the time 

of the survey that are not resolved, as 

determined by the Accreditation Body, 

within the OTP’s three-year 

accreditation period and that remain 

areas of non-compliance during the 

OTP’s subsequent three-year 

accreditation renewal survey, shall 

automatically be categorized as 

‘‘significant’’ non-compliant conditions 

for purposes of the renewal survey and 

must be corrected in accordance with 

paragraph (b)(1)(i) of this section. 

(4) OTPs that are required to correct 

significant non-compliant conditions 

shall be granted a one-year 

accreditation, beginning from the end 

date of the current and expiring 

accreditation period. An OTP’s 

accreditation must be revoked if it fails 

to correct significant non-compliant 

conditions within the schedule 

provided under paragraph (b)(1)(i) of 

this section. If an Accrediting Body 

verifies that an OTP has corrected the 

significant non-compliant conditions 

identified within the specified schedule, 

it shall extend the OTP’s accreditation 

period by an additional two years. 

(5) In cases of severe non-compliance 

with the requirements of § 8.12 that 

pose immediate risks to patient health 

and safety, the Accreditation Body shall 

inform the OTP and Secretary within 48 

hours and provide a detailed written 

report of the non-compliance within 5 

business days. The Accreditation Body 

shall give the OTP 30 days from the date 

of the non-compliance report to correct 

the non-compliance issue(s). A followup survey shall be conducted by the 

Accreditation Body within 30 days of 

the expected correction date to ensure 

successful remediation. Should the OTP 

not rectify the non-compliance within 

the 30-day period, the Accreditation 

Body shall revoke the OTP’s 


khammond on DSKJM1Z7X2PROD with RULES4
7554 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

accreditation. The Secretary will then 

make a decision regarding the OTP’s 

certification in accordance with the 

procedures under § 8.13. 

(c) Recordkeeping. (1) Accreditation 

Bodies shall maintain, and make 

available as requested by the Secretary, 

records of their accreditation activities 

for at least 5 years from the creation of 

the record. Such records must contain 

sufficient detail to support each 

accreditation decision made by the 

Accreditation Body. 

(2) Accreditation Bodies shall 

establish procedures to protect 

confidential information collected or 

received in their role as Accreditation 

Bodies that are consistent with, and that 

are designed to ensure compliance with, 

all Federal and State laws, including 42 

CFR part 2. 

(i) Information collected or received 

for the purpose of carrying out 

Accreditation Body responsibilities 

shall not be used for any other purpose 

or disclosed, other than to the Secretary 

or its duly designated representatives, 

unless otherwise required by law or 

with the consent of the OTP. 

(ii) Nonpublic information that the 

Secretary shares with the Accreditation 

Body concerning an OTP shall not be 

further disclosed except with the 

written permission of the Secretary. 

(d) Reporting. (1) Accreditation 

Bodies shall provide to the Secretary 

any documents and information 

requested by the Secretary within 5 days 

of receipt of the request. 

(2) Accreditation Bodies shall submit 

a summary of the results of each 

accreditation survey to the Secretary 

within 90 days following the survey 

visit. Such summaries shall contain 

sufficient detail to justify the 

accreditation action taken. 

(3) Accreditation Bodies shall provide 

the Secretary a list of each OTP 

surveyed, and the identity of all 

individuals involved in the conducting 

and reporting of survey results. 

(4) Accreditation Bodies shall submit 

to the Secretary the name of each OTP 

for which the Accreditation Body 

accredits conditionally, denies, 

suspends, or revokes accreditation, and 

the basis for the action, within 48 hours 

of the action. 

(5) Notwithstanding any reports made 

to the Secretary under paragraphs (d)(1) 

through (4) of this section, each 

Accreditation Body shall submit to the 

Secretary semiannually, on January 15 

and July 15 of each calendar year, a 

report consisting of a summary of the 

results of each accreditation survey 

conducted in the past year. The 

summary shall contain sufficient detail 

to justify each accreditation action 

taken. 

(6) All reporting requirements listed 

in this section shall be provided to the 

Secretary at the address specified in 

§ 8.3(b). 

(e) Complaint response. Accreditation 

Bodies shall have policies and 

procedures in place to respond to 

complaints received from the Secretary, 

patients, facility staff, and others within 

5 business days from the receipt of the 

complaint. Accreditation Bodies shall 

also agree to notify the Secretary within 

5 business days of receipt of a complaint 

from a patient, facility, staff or others, 

and to inform the Secretary of their 

response to the complaint. 

(f) Modifications of accreditation 

elements. Accreditation Bodies shall 

obtain the Secretary’s written 

authorization prior to making any 

substantive (i.e., noneditorial) change in 

accreditation elements. 

(g) Conflicts of interest. The 

Accreditation Body shall maintain and 

apply policies and procedures that the 

Secretary has approved in accordance 

with § 8.3 to reduce the possibility of 

actual conflict of interest, or the 

appearance of a conflict of interest, on 

the part of individuals who act on 

behalf of the Accreditation Body. 

Individuals who participate in 

accreditation surveys or otherwise 

participate in the accreditation decision 

or an appeal of the accreditation 

decision, as well as their spouses and 

minor children, shall not have a 

financial interest in the OTP that is the 

subject of the accreditation survey or 

decision. 

(h) Accreditation teams. (1) An 

Accreditation Body survey team shall 

consist of healthcare professionals with 

expertise in OUD treatment. The 

Accreditation Body shall consider 

factors such as the size of the OTP, the 

anticipated number of survey noncompliance issues, and the OTP’s 

accreditation history in determining the 

composition of the team. At a minimum, 

survey teams shall consist of at least two 

healthcare professionals whose 

combined expertise includes: 

(i) The dispensing and administration 

of medications subject to control under 

the Controlled Substances Act (21 

U.S.C. 801 et seq.); 

(ii) Medical issues relating to the 

dosing and administration of MOUD for 

the treatment of OUD; 

(iii) Psychosocial counseling of 

individuals receiving OUD treatment; 

and 

(iv) Organizational and administrative 

issues associated with OTPs. 

(2) Members of the accreditation team 

must be able to recuse themselves at any 

time from any survey in which either 

they or the OTP believes there is an 

actual conflict of interest or the 

appearance of a conflict of interest. 

Conflict or perceived conflict of interest 

must be documented by the 

Accreditation Body and made available 

to the Secretary. 

(i) Accreditation fees. Fees charged to 

OTPs for accreditation shall be 

reasonable. the Secretary generally will 

find fees to be reasonable if the fees are 

limited to recovering costs to the 

Accreditation Body, including overhead 

incurred. Accreditation Body activities 

that are not related to accreditation 

functions are not recoverable through 

fees established for accreditation. 

(1) The Accreditation Body shall 

make public its fee structure, including 

those factors, if any, contributing to 

variations in fees for different OTPs. 

(2) At the Secretary’s request, 

Accreditation Bodies shall provide to 

the Secretary financial records or other 

materials, in a manner specified by the 

Secretary, to assist in assessing the 

reasonableness of Accreditation Body 

fees. 

§ 8.5 Periodic evaluation of Accreditation 

Bodies. 

The Secretary will periodically 

evaluate the performance of 

Accreditation Bodies primarily by 

inspecting a selected sample of the 

OTPs accredited by the Accrediting 

Body, and by evaluating the 

Accreditation Body’s reports of surveys 

conducted, to determine whether the 

OTPs surveyed and accredited by the 

Accreditation Body are in compliance 

with applicable standards under this 

part. The evaluation will include a 

determination of whether there are 

major deficiencies in the Accreditation 

Body’s performance that, if not 

corrected, would warrant withdrawal of 

the approval of the Accreditation Body 

under § 8.6. 

§ 8.6 Withdrawal of approval of 

Accreditation Bodies. 

If the Secretary determines that an 

Accreditation Body is not in substantial 

compliance with this subpart, the 

Secretary shall take appropriate action 

as follows: 

(a) Major deficiencies. If the Secretary 

determines that the Accreditation Body 

has a major deficiency, such as 

commission of fraud, material false 

statement, failure to perform a major 

accreditation function satisfactorily, or 

significant noncompliance with the 

requirements of this subpart, the 

Secretary shall withdraw approval of 

that Accreditation Body. 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7555 

(1) In the event of a major deficiency, 

the Secretary shall notify the 

Accreditation Body of the agency’s 

action and the grounds on which the 

approval was withdrawn. 

(2) An Accreditation Body that has 

lost its approval shall notify each OTP 

that has been accredited or is seeking 

accreditation that the Accreditation 

Body’s approval has been withdrawn. 

Such notification shall be made within 

a time period and in a manner approved 

by the Secretary. 

(b) Minor deficiencies. If the Secretary 

determines that the Accreditation Body 

has minor deficiencies in the 

performance of an accreditation 

function, that are less serious or more 

limited than the types of deficiencies 

described in paragraph (a) of this 

section, the Secretary will notify the 

Body that it has 90 days to submit to the 

Secretary a plan of corrective action. 

The plan must include a summary of 

corrective actions and a schedule for 

their implementation. The Secretary 

may place the Body on probationary 

status for a period of time determined 

by the Secretary, or may withdraw 

approval of the Body if corrective action 

is not taken. 

(1) If the Secretary places an 

Accreditation Body on probationary 

status, the Body shall notify all OTPs 

that have been accredited, or that are 

seeking accreditation, of the 

Accreditation Body’s probationary 

status within a time period and in a 

manner approved by the Secretary. 

(2) Probationary status will remain in 

effect until such time as the Body can 

demonstrate to the satisfaction of the 

Secretary that it has successfully 

implemented or is implementing the 

corrective action plan within the 

established schedule, and the corrective 

actions taken have substantially 

eliminated all identified problems. 

(3) If the Secretary determines that an 

Accreditation Body that has been placed 

on probationary status is not 

implementing corrective actions 

satisfactorily or within the established 

schedule, the Secretary may withdraw 

approval of the Accreditation Body. The 

Accreditation Body shall notify all OTPs 

that have been accredited, or are seeking 

accreditation, of the Accreditation 

Body’s loss of the Secretary’s approval 

within a time period and in a manner 

approved by the Secretary. 

(c) Reapplication. (1) An 

Accreditation Body that has had its 

approval withdrawn may submit a new 

application for approval if the Body can 

provide information to the Secretary to 

establish that the problems that were 

grounds for withdrawal of approval 

have been resolved. 

(2) If the Secretary determines that the 

new application demonstrates that the 

Body satisfactorily has addressed the 

causes of its previous unacceptable 

performance, the Secretary may 

reinstate approval of the Accreditation 

Body. 

(3) The Secretary may request 

additional information or establish 

additional conditions that must be met 

before the Secretary approves the 

reapplication. 

(4) The Secretary may refuse to accept 

an application from a former 

Accreditation Body whose approval was 

withdrawn because of fraud, material 

false statement, or willful disregard of 

public health. 

(d) Hearings. An opportunity to 

challenge an adverse action taken 

regarding withdrawal of approval of an 

Accreditation Body shall be addressed 

through the relevant procedures set 

forth in subpart C of this part, except 

that the procedures in § 8.28 for 

expedited review of an immediate 

suspension would not apply to an 

Accreditation Body that has been 

notified under paragraph (a) or (b) of 

this section of the withdrawal of its 

approval. 

Subpart C—Certification and 

Treatment Standards for Opioid 

Treatment Programs 

§ 8.11 Opioid Treatment Program 

certification. 

(a) General. (1) An OTP must be the 

subject of a current, valid certification 

from the Secretary to be considered 

qualified by the Secretary under section 

303(g)(1) of the Controlled Substances 

Act (21 U.S.C. 823(h)(1)) to dispense 

MOUD in the treatment of OUD. An 

OTP must be determined to be qualified 

under section 303(g)(1) of the Controlled 

Substances Act, and must be 

determined to be qualified by the 

Attorney General under section 

303(g)(1), to be registered by the 

Attorney General to dispense MOUD to 

individuals for treatment of OUD. 

(2) To obtain certification from the 

Secretary, an OTP must meet the 

Federal Opioid Use Disorder treatment 

standards in § 8.12, must be the subject 

of a current, valid accreditation by an 

Accreditation Body or other entity 

designated by the Secretary and must 

comply with any other conditions for 

certification established by the 

Secretary. 

(3) OTPs are expected to maintain 

certification with the Secretary and to 

comply with any other conditions for 

certification established by the 

Secretary. Certification shall be granted 

for a term not to exceed 3 years, except 

that certification may be renewed 

during the final certification year if the 

OTP applies for certification renewal in 

accordance with the steps outlined in 

paragraph (a)(4) of this section. 

(4) OTPs which satisfy the criteria for 

certification under this section may 

apply for renewal of their certification. 

OTPs are expected to apply for 

certification renewal during the final 

year of the OTP’s certification period. 

OTPs should take steps to ensure that 

administrative tasks associated with 

renewal are completed before the OTP’s 

certification expires. OTPs may apply 

for certification renewal in accordance 

with the procedures as outlined in 

paragraph (b) of this section. If an OTP 

anticipates any delays in routine 

certification renewal, an extension may 

be requested by submitting to the 

Secretary a statement justifying the 

extension in accordance with paragraph 

(e) of this section. 

(5) OTPs that are certified and are 

seeking certification renewal, and who 

have been granted accreditation for one 

year by an Accreditation Body as 

provided under § 8.4(b)(1)(iii), may 

receive a conditional certification for 

one year unless the Secretary 

determines that such conditional 

certification would adversely affect 

patient health. An OTP must obtain a 

standard 3-year certification, as 

described in paragraph (a)(3) of this 

section, within the 1-year conditional 

certification period. If standard 

accreditation is not obtained by the OTP 

within the 1-year conditional 

certification period, the OTP’s 

conditional certification will lapse, and 

the Attorney General will be notified 

that the OTP’s registration should be 

revoked. 

(6) OTPs whose certification has 

expired, and who seek re-certification, 

will be considered ‘‘new’’ programs and 

will be required to apply for provisional 

certification in accordance with 

paragraph (d) of this section. 

(b) Application for initial or renewal 

certifications and re-certification. 

Applications for certification must be 

submitted by the OTP using form SMA– 

162. The application for initial or 

renewal of certification shall include, as 

determined by the Secretary: 

(1) A description of the current 

accreditation status of the OTP; 

(2) A description of the organizational 

structure of the OTP; 

(3) The names of the persons 

responsible for the OTP; 

(4) The addresses of the OTP and of 

each medication unit or other facility 

under the of the OTP; 

(5) The sources of funding for the OTP 

and the name and address of each 


khammond on DSKJM1Z7X2PROD with RULES4
7556 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

governmental entity that provides such 

funding; 

(6) A statement that the OTP will 

comply with the conditions of 

certification set forth in paragraph (g) of 

this section; and 

(7) The application shall be signed by 

the program sponsor who shall certify 

that the information submitted in the 

application is truthful and accurate. 

(8) Applications for re-certification 

shall include an explanation of why the 

OTP’s most recent certification expired 

and information regarding the schedule 

for an accreditation survey. 

(c) Action on application. (1) 

Following the Secretary’s receipt of an 

application for certification of an OTP, 

and after consultation with the 

appropriate State authority regarding 

the qualifications of the applicant, the 

Secretary may grant the application for 

certification, or renew an existing 

certification, if the Secretary determines 

that the OTP has satisfied the 

requirements for certification or renewal 

of certification in this section. 

(2) The Secretary may deny the 

application if the Secretary determines 

that: 

(i) The application for certification is 

deficient in any respect; 

(ii) The OTP will not be operated in 

accordance with the Federal Opioid Use 

Disorder treatment standards 

established under § 8.12; 

(iii) The OTP will not permit an 

inspection or a survey to proceed, or 

will not permit in a timely manner 

access to relevant records or 

information; or 

(iv) The OTP has made 

misrepresentations in obtaining 

accreditation or in applying for 

certification. 

(3) Within 5 days after it reaches a 

final determination that an OTP meets 

the requirements for certification in this 

section, the Secretary will notify the 

Drug Enforcement Administration 

(DEA) that the OTP has been 

determined to be qualified to provide 

OUD treatment under section 303(g)(1) 

of the Controlled Substances Act. 

(d) Provisional certification. New 

OTPs that have not received the 

Secretary’s certification previously, 

except as provided in paragraph (a)(6) of 

this section, who are applying for 

certification from the Secretary, and 

who have applied for accreditation with 

an Accreditation Body, are eligible to 

receive provisional certification for up 

to 1 year. To receive provisional 

certification, an OTP shall submit the 

information required by paragraph (b) of 

this section to the Secretary along with 

a statement identifying the 

Accreditation Body to which the OTP 

has applied for accreditation, the date 

on which the OTP applied for 

accreditation, the dates of any 

accreditation surveys that have taken 

place or are expected to take place, and 

the expected schedule for completing 

the accreditation process. Provisional 

certification for up to 1 year will be 

granted, following receipt of the 

information described in this paragraph 

(d), unless the Secretary determines that 

patient health would be adversely 

affected by the granting of provisional 

certification. 

(e) Requirements for certification. (1) 

OTPs shall comply with all pertinent 

Federal and State laws and regulations. 

Nothing in this part is intended to limit 

the authority of State and, as 

appropriate, local governmental entities 

to regulate the use of MOUD in the 

treatment of OUD. The provisions of 

this section requiring compliance with 

requirements imposed by State law, or 

the submission of applications or 

reports required by the State authority, 

do not apply to OTPs operated directly 

by the Department of Veterans Affairs, 

the Indian Health Service, or any other 

department or agency of the United 

States. 

(2) OTPs shall allow, in accordance 

with Federal controlled substances laws 

and Federal confidentiality laws, 

inspections and surveys by duly 

authorized employees of the Department 

of Health and Human Services (HHS) or 

Substance Abuse and Mental Health 

Services Administration (SAMHSA), by 

Accreditation Bodies, by the Drug 

Enforcement Administration (DEA), and 

by authorized employees of any other 

Federal governmental entity with legal 

authority to conduct inspections or 

surveys on an OTP’s premises. 

(3) Disclosure of patient records 

maintained by an OTP is governed by 

the provisions of 42 CFR part 2 and 45 

CFR parts 160 and 164, and every 

program must comply with these 

regulations, as applicable. Records on 

the receipt, storage, and distribution of 

MOUD are also subject to inspection 

under Federal controlled substances 

laws and under the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 321 et 

seq.). Federally sponsored treatment 

programs are subject to applicable 

Federal confidentiality statutes. 

(4) An OTP or medication unit or any 

part thereof, including any facility or 

any individual, shall permit a duly 

authorized employee of the Department 

of Health and Human Services or 

SAMHSA to have access to and to copy 

all records on the use of MOUD in 

accordance with the provisions of 42 

CFR part 2 and 45 CFR parts 160 and 

164. 

(5) OTPs shall notify the Secretary in 

writing within 3 weeks of any 

replacement or other change in the 

status of the program sponsor or 

medical director. 

(6) OTPs shall comply with all 

regulations enforced by the DEA under 

21 CFR chapter II and must be registered 

by the DEA before administering or 

dispensing MOUD. 

(7) OTPs must operate in accordance 

with Federal Opioid Use Disorder 

treatment standards and approved 

accreditation elements. 

(f) Conditions for interim treatment 

program approval. (1) Before an OTP 

may provide interim treatment, the OTP 

must receive the approval of both the 

Secretary and the SOTA of the State in 

which the OTP operates. 

(2) Before the Secretary may grant 

such approval, the OTP must provide 

the Secretary with documentation from 

the SOTA of the State in which the OTP 

operates demonstrating that: 

(i) Such officer does not object to the 

providing of interim treatment in the 

State; 

(ii) The OTP seeking to provide such 

treatment is unable to provide access for 

patients in a comprehensive treatment 

program within a reasonable geographic 

area within 14 days of the time patients 

seek treatment for OUD; 

(iii) The authorization of the OTP to 

provide interim treatment will not 

otherwise reduce the capacity of 

comprehensive treatment programs in 

the State to admit individuals (relative 

to the date on which such officer so 

certifies); and 

(iv) OTPs providing interim treatment 

will arrange for each individual’s 

transfer to a comprehensive treatment 

program no later than 180 days from the 

date on which each individual first 

requested treatment. Individuals 

enrolled in interim treatment shall not 

be discharged without the approval of 

an OTP practitioner, who shall consider 

on-going and patient-centered treatment 

needs, which are to be documented in 

the patient record, while awaiting 

transfer to a comprehensive treatment 

program. 

(3) The Secretary will provide notice 

to the OTP denying or approving the 

request to provide interim treatment. 

The OTP shall not provide such 

treatment until it has received such 

notice from the Secretary. 

(g) Exemptions. An OTP may, at the 

time of application for certification or 

any time thereafter, request from the 

Secretary exemption from the regulatory 

requirements set forth under this section 

and § 8.12. An example of a case in 

which an exemption might be granted 

would be for a private practitioner who 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7557 

wishes to treat a limited number of 

patients in a non-metropolitan area with 

few physicians and no OUD treatment 

services geographically accessible, and 

requests exemption from some of the 

staffing and service standards. The OTP 

shall support the rationale for the 

exemption with thorough 

documentation, to be supplied in an 

appendix to the initial application for 

certification or in a separate submission. 

The Secretary will approve or deny such 

exemptions at the time of application, or 

any time thereafter, if appropriate. The 

Secretary shall consult with the 

appropriate State authority prior to 

taking action on an exemption request. 

(h) Medication units, long-term care 

facilities and hospitals. (1) Certified 

OTPs may establish medication units 

that are authorized to dispense MOUD. 

Before establishing a medication unit, a 

certified OTP must notify the Secretary 

by submitting form SMA–162. The OTP 

must also comply with the provisions of 

21 CFR part 1300 before establishing a 

medication unit. Medication units shall 

comply with all pertinent State laws 

and regulations. Medication units 

include both mobile and brick and 

mortar facilities. 

(2) Specifically, any services that are 

provided in an OTP may be provided in 

the medication unit, assuming 

compliance with all applicable Federal, 

State, and local law, and the use of units 

that provide appropriate privacy and 

have adequate space. 

(3) Certification as an OTP under this 

part is not required for the initiation or 

continuity of medication treatment or 

withdrawal management of a patient 

who is admitted to a hospital, long-term 

care facility, or correctional facility, that 

is registered with the Drug Enforcement 

Administration as a hospital/clinic, for 

the treatment of medical conditions 

other than OUD, and who requires 

treatment of OUD with methadone 

during their stay, when such treatment 

is permitted under applicable Federal 

law. 

(i) The term ‘‘long-term care facility’’ 

is defined in § 8.2. Nothing in this 

section is intended to relieve hospitals, 

or long-term care facilities and 

correctional facilities that are registered 

with the Drug Enforcement 

Administration as a hospital/clinic, 

from their obligations to obtain 

appropriate registration from the 

Attorney General, under section 303(g) 

of the Controlled Substances Act. 

Treatment provided under this section 

should always comply with applicable 

Federal laws. 

(ii) [Reserved] 

§ 8.12 Federal Opioid Use Disorder 

treatment standards. 

(a) General. OTPs must provide 

treatment in accordance with the 

standards in this section and must 

comply with these standards as a 

condition of certification. 

(b) Administrative and organizational 

structure. (1) An OTP’s organizational 

structure and facilities shall be adequate 

to ensure quality patient care and to 

meet the requirements of all pertinent 

Federal, State, and local laws and 

regulations. At a minimum, each OTP 

shall formally designate a program 

sponsor and medical director. The 

program sponsor shall agree on behalf of 

the OTP to adhere to all requirements 

set forth in this part. 

(2) The medical director shall assume 

responsibility for all medical and 

behavioral health services performed by 

the OTP. In addition, the medical 

director shall be responsible for 

ensuring that the OTP is in compliance 

with all applicable Federal, State, and 

local laws and regulations. 

(c) Continuous quality improvement. 

(1) An OTP must maintain current 

quality assurance and quality control 

plans that include, among other things, 

annual reviews of program policies and 

procedures and ongoing assessment of 

patient outcomes. 

(2) An OTP must maintain a current 

‘‘Diversion Control Plan’’ or ‘‘DCP’’ as 

part of its quality assurance program 

that contains specific measures to 

reduce the possibility of diversion of 

dispensed MOUD, and that assigns 

specific responsibility to the OTP 

providers and administrative staff for 

carrying out the diversion control 

measures and functions described in the 

DCP. 

(d) Staff credentials. 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. All practitioners and 

other licensed/certified health care 

providers, including counselors, must 

comply with the credentialing and 

maintenance of licensure and/or 

certification requirements of their 

respective professions. 

(e) Patient admission criteria—(1) 

Comprehensive treatment. An OTP shall 

maintain current procedures designed to 

ensure that patients are admitted to 

treatment by qualified personnel who 

have determined, using accepted 

medical criteria, that: The person meets 

diagnostic criteria for a moderate to 

severe OUD; the individual has an 

active moderate to severe OUD, or OUD 

in remission, or is at high risk for 

recurrence or overdose. Such decisions 

must be appropriately documented in 

the patient’s clinical record. In addition, 

a health care practitioner shall ensure 

that each patient voluntarily chooses 

treatment with MOUD and that all 

relevant facts concerning the use of 

MOUD are clearly and adequately 

explained to the patient, and that each 

patient provides informed consent to 

treatment. 

(2) Comprehensive treatment for 

persons under age 18. Except in States 

where State law grants persons under 18 

years of age the ability to consent to 

OTP treatment without the consent of 

another, no person under 18 years of age 

may be admitted to OTP treatment 

unless a parent, legal guardian, or 

responsible adult designated by the 

relevant State authority consents in 

writing to such treatment. 

(3) Withdrawal management. An OTP 

shall maintain current procedures that 

are designed to ensure that those 

patients who choose to taper from 

MOUD are provided the opportunity to 

do so with informed consent and at a 

mutually agreed-upon rate that 

minimizes taper-related risks. Such 

consent must be documented in the 

clinical record by the treating 

practitioner. 

(f) Required services—(1) General. 

OTPs shall provide adequate medical, 

counseling, vocational, educational, and 

other screening, assessment, and 

treatment services to meet patient 

needs, with the combination and 

frequency of services tailored to each 

individual patient based on an 

individualized assessment and the 

patient’s care plan that was created after 

shared decision making between the 

patient and the clinical team. These 

services must be available at the 

primary facility, except where the 

program sponsor has entered into a 

documented agreement with a private or 

public agency, organization, 

practitioner, or institution to provide 

these services to patients enrolled in the 

OTP. The program sponsor, in any 

event, must be able to document that 

these services are fully and reasonably 

available to patients. 

(2) Initial medical examination. (i) 

OTPs shall require each patient to 

undergo an initial medical examination. 

The initial medical examination is 

comprised of two parts: 

(A) A screening examination to ensure 

that the patient meets criteria for 

admission and that there are no 

contraindications to treatment with 

MOUD; and 

(B) A full history and examination, to 

determine the patient’s broader health 

status, with lab testing as determined to 

be required by an appropriately licensed 


khammond on DSKJM1Z7X2PROD with RULES4
7558 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

practitioner. A patient’s refusal to 

undergo lab testing for co-occurring 

physical health conditions should not 

preclude them from access to treatment, 

provided such refusal does not have 

potential to negatively impact treatment 

with medications. 

(ii) Assuming no contraindications, a 

patient may commence treatment with 

MOUD after the screening examination 

has been completed. Both the screening 

examination and full examination must 

be completed by an appropriately 

licensed practitioner. If the licensed 

practitioner is not an OTP practitioner, 

the screening examination must be 

completed no more than seven days 

prior to OTP admission. Where the 

examination is performed outside of the 

OTP, the written results and narrative of 

the examination, as well as available lab 

testing results, must be transmitted, 

consistent with applicable privacy laws, 

to the OTP, and verified by an OTP 

practitioner. 

(iii) A full in-person physical 

examination, including the results of 

serology and other tests that are 

considered to be clinically appropriate, 

must be completed within 14 calendar 

days following a patient’s admission to 

the OTP. The full exam can be 

completed by a non-OTP practitioner, if 

the exam is verified by a licensed OTP 

practitioner as being true and accurate 

and transmitted in accordance with 

applicable privacy laws. 

(iv) Serology testing and other testing 

as deemed medically appropriate by the 

licensed OTP practitioner based on the 

screening or full history and 

examination, drawn not more than 30 

days prior to admission to the OTP, may 

form part of the full history and 

examination. 

(v) The screening and full 

examination may be completed via 

telehealth for those patients being 

admitted for treatment at the OTP with 

either buprenorphine or methadone, if a 

practitioner or primary care provider, 

determines that an adequate evaluation 

of the patient can be accomplished via 

telehealth. When using telehealth, the 

following caveats apply: 

(A) In evaluating patients for 

treatment with schedule II medications 

(such as Methadone), audio-visual 

telehealth platforms must be used, 

except when not available to the patient. 

When not available, it is acceptable to 

use audio-only devices, but only when 

the patient is in the presence of a 

licensed practitioner who is registered 

to prescribe (including dispense) 

controlled medications. The OTP 

practitioner shall review the 

examination results and order treatment 

medications as indicated. 

(B) In evaluating patients for 

treatment with schedule III medications 

(such as Buprenorphine) or medications 

not classified as a controlled medication 

(such as Naltrexone), audio-visual or 

audio only platforms may be used. The 

OTP practitioner shall review the 

examination results and order treatment 

medications as indicated. 

(3) Special services for pregnant 

patients. OTPs must maintain current 

policies and procedures that reflect the 

special needs and priority for treatment 

admission of patients with OUD who 

are pregnant. Pregnancy should be 

confirmed. Evidence-based treatment 

protocols for the pregnant patient, such 

as split dosing regimens, may be 

instituted after assessment by an OTP 

practitioner and documentation that 

confirms the clinical appropriateness of 

such an evidence-based treatment 

protocol. Prenatal care and other sexspecific services, including reproductive 

health services, for pregnant and 

postpartum patients must be provided 

and documented either by the OTP or 

by referral to appropriate healthcare 

practitioners. Specific services, 

including reproductive health services, 

for pregnant and postpartum patients 

must be provided and documented 

either by the OTP or by referral to 

appropriate healthcare practitioners. 

(4) Initial and periodic physical and 

behavioral health assessment services. 

(i) Each patient admitted to an OTP 

shall be given a physical and behavioral 

health assessment, which includes but 

is not limited to screening for imminent 

risk of harm to self or others, within 14 

calendar days following admission, and 

periodically by appropriately licensed/ 

credentialed personnel. These 

assessments must address the need for 

and/or response to treatment, adjust 

treatment interventions, including 

MOUD, as necessary, and provide a 

patient-centered plan of care. The full, 

initial psychosocial assessment must be 

completed within 14 calendar days of 

admission and include preparation of a 

care plan that includes the patient’s 

goals and mutually agreed-upon actions 

for the patient to meet those goals, 

including harm reduction interventions; 

the patient’s needs and goals in the 

areas of education, vocational training, 

and employment; and the medical and 

psychiatric, psychosocial, economic, 

legal, housing, and other recovery 

support services that a patient needs 

and wishes to pursue. The care plan 

also must identify the recommended 

frequency with which services are to be 

provided. The plan must be reviewed 

and updated to reflect responses to 

treatment and recovery support services, 

and adjustments made that reflect 

changes in the context of the person’s 

life, their current needs for and interests 

in medical, psychiatric, social, and 

psychological services, and current 

needs for and interests in education, 

vocational training, and employment 

services. 

(ii) The periodic physical examination 

should occur not less than one time 

each year and be conducted by an OTP 

practitioner. The periodic physical 

examination should include review of 

MOUD dosing, treatment response, 

other substance use disorder treatment 

needs, responses and patient-identified 

goals, and other relevant physical and 

psychiatric treatment needs and goals. 

The periodic physical examination 

should be documented in the patient’s 

clinical record. 

(5) Counseling and psychoeducational 

services. (i) OTPs must provide 

adequate substance use disorder 

counseling and psychoeducation to each 

patient as clinically necessary and 

mutually agreed-upon, including harm 

reduction education and recoveryoriented counseling. This counseling 

shall be provided by a program 

counselor, qualified by education, 

training, or experience to assess the 

psychological and sociological 

background of patients, and engage with 

patients, to contribute to the appropriate 

care plan for the patient and to monitor 

and update patient progress. Patient 

refusal of counseling shall not preclude 

them from receiving MOUD. 

(ii) OTPs must provide counseling on 

preventing exposure to, and the 

transmission of, human 

immunodeficiency virus (HIV), viral 

hepatitis, and sexually transmitted 

infections (STIs) and either directly 

provide services and treatments or 

actively link to treatment each patient 

admitted or readmitted to treatment 

who has received positive test results 

for these conditions from initial and/or 

periodic medical examinations. 

(iii) OTPs must provide directly, or 

through referral to adequate and 

reasonably accessible community 

resources, vocational training, 

education, and employment services for 

patients who request such services or 

for whom these needs have been 

identified and mutually agreed-upon as 

beneficial by the patient and program 

staff. 

(6) Drug testing services. When 

conducting random drug testing, OTPs 

must use drug tests that have received 

the Food and Drug Administration’s 

(FDA) marketing authorization for 

commonly used and misused substances 

that may impact patient safety, recovery, 

or otherwise complicate substance use 

disorder treatment, at a frequency that is 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7559 

in accordance with generally accepted 

clinical practice and as indicated by a 

patient’s response to and stability in 

treatment, but no fewer than eight 

random drug tests per year patient, 

allowing for extenuating circumstances 

at the individual patient level. This 

requirement does not preclude 

distribution of legal harm reduction 

supplies that allow an individual to test 

their personal drug supply for 

adulteration with substances that 

increase the risk of overdose. 

(g) Recordkeeping and patient 

confidentiality. (1) OTPs shall establish 

and maintain a recordkeeping system 

that is adequate to document and 

monitor patient care. This system is 

required to comply with all Federal and 

State reporting requirements relevant to 

MOUD approved for use in treatment of 

OUD. All records are required to be kept 

confidential in accordance with all 

applicable Federal and State 

requirements. 

(2) OTPs shall include, as an essential 

part of the recordkeeping system, 

documentation in each patient’s record 

that the OTP made a good faith effort to 

determine whether the patient is 

enrolled in any other OTP. A patient 

enrolled in an OTP shall not be 

permitted to obtain treatment in any 

other OTP except in circumstances 

involving an inability to access care at 

the patient’s OTP of record. Such 

circumstances include, but are not 

limited to, travel for work or family 

events, temporary relocation, or an 

OTP’s temporary closure. If the medical 

director or program practitioner of the 

OTP in which the patient is enrolled 

determines that such circumstances 

exist, the patient may seek treatment at 

another OTP, provided the justification 

for the particular circumstances are 

noted in the patient’s record both at the 

OTP in which the patient is enrolled 

and at the OTP that will provide the 

MOUD. 

(h) Medication administration, 

dispensing, and use. (1) OTPs must 

ensure that MOUD are administered or 

dispensed only by a practitioner 

licensed under the appropriate State law 

and registered under the appropriate 

State and Federal laws to administer or 

dispense MOUD, or by an agent of such 

a practitioner, supervised by and under 

the order of the licensed practitioner 

and if consistent with Federal and State 

law. 

(2) OTPs shall use only those MOUD 

that are approved by the Food and Drug 

Administration under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355) for use in the treatment 

of OUD. In addition, OTPs who are fully 

compliant with the protocol of an 

investigational use of a drug and other 

conditions set forth in the application 

may administer a drug that has been 

authorized by the Food and Drug 

Administration under an investigational 

new drug application under section 

505(i) of the Federal Food, Drug, and 

Cosmetic Act for investigational use in 

the treatment of OUD. Currently the 

following MOUD will be considered to 

be approved by the Food and Drug 

Administration for use in the treatment 

of OUD: 

(i) Methadone; 

(ii) Buprenorphine and 

buprenorphine combination products 

that have been approved for use in the 

treatment of OUD; and 

(iii) Naltrexone. 

(3) OTPs shall maintain current 

procedures that are adequate to ensure 

that the following dosage form and 

initial dosing requirements are met: 

(i) Methadone shall be administered 

or dispensed only in oral form and shall 

be formulated in such a way as to 

reduce its potential for parenteral 

misuse. 

(ii) For each new patient enrolled in 

an OTP, the initial dose of methadone 

shall be individually determined and 

shall include consideration of the 

type(s) of opioid(s) involved in the 

patient’s opioid use disorder, other 

medications or substances being taken, 

medical history, and severity of opioid 

withdrawal. The total dose for the first 

day should not exceed 50 milligrams 

unless the OTP practitioner, licensed 

under the appropriate State law and 

registered under the appropriate State 

and Federal laws to administer or 

dispense MOUD, finds sufficient 

medical rationale, including but not 

limited to if the patient is transferring 

from another OTP on a higher dose that 

has been verified, and documents in the 

patient’s record that a higher dose was 

clinically indicated. 

(4) OTPs shall maintain current 

procedures adequate to ensure that each 

MOUD used by the program is 

administered and dispensed in 

accordance with its FDA approved 

product labeling. The program must 

ensure that any significant deviations 

from the approved labeling, including 

deviations with regard to dose, 

frequency, or the conditions of use 

described in the approved labeling, are 

specifically documented in the patient’s 

record. 

(i) Unsupervised or ‘‘take-home’’ 

medication doses. Unsupervised or 

‘‘take-home’’ medication doses may be 

provided under the following 

circumstances: 

(1) Any patient in comprehensive 

treatment may receive their 

individualized take-home doses as 

ordered for days that the clinic is closed 

for business, including one weekend 

day (e.g., Sunday) and State and Federal 

holidays, no matter their length of time 

in treatment. 

(2) OTP decisions on dispensing 

MOUD to patients for unsupervised use 

beyond that set forth in paragraph (i)(1) 

of this section shall be determined by an 

appropriately licensed OTP medical 

practitioner or the medical director. In 

determining which patients may receive 

unsupervised medication doses, the 

medical director or program medical 

practitioner shall consider, among other 

pertinent factors that indicate that the 

therapeutic benefits of unsupervised 

doses outweigh the risks, the following 

criteria: 

(i) Absence of active substance use 

disorders, other physical or behavioral 

health conditions that increase the risk 

of patient harm as it relates to the 

potential for overdose, or the ability to 

function safely; 

(ii) Regularity of attendance for 

supervised medication administration; 

(iii) Absence of serious behavioral 

problems that endanger the patient, the 

public or others; 

(iv) Absence of known recent 

diversion activity; 

(v) Whether take-home medication 

can be safely transported and stored; 

and 

(vi) Any other criteria that the 

medical director or medical practitioner 

considers relevant to the patient’s safety 

and the public’s health. 

(3) Such determinations and the basis 

for such determinations consistent with 

the criteria outlined in paragraph (i)(2) 

of this section shall be documented in 

the patient’s medical record. If it is 

determined that a patient is safely able 

to manage unsupervised doses of 

MOUD, the dispensing restrictions set 

forth in paragraphs (i)(3)(i) through (iii) 

of this section apply. The dispensing 

restrictions set forth in paragraphs 

(i)(3)(i) through (iii) of this section do 

not apply to buprenorphine and 

buprenorphine products listed under 

paragraph (h)(2)(ii) of this section. 

(i) During the first 14 days of 

treatment, the take-home supply 

(beyond that of paragraph (i)(1) of this 

section) is limited to 7 days. It remains 

within the OTP practitioner’s discretion 

to determine the number of take-home 

doses up to 7 days, but decisions must 

be based on the criteria listed in 

paragraph (i)(2) of this section. The 

rationale underlying the decision to 

provide unsupervised doses of 

methadone must be documented in the 

patient’s clinical record, consistent with 

paragraph (g)(2) of this section. 


khammond on DSKJM1Z7X2PROD with RULES4
7560 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

(ii) From 15 days of treatment, the 

take-home supply (beyond that of 

paragraph (i)(1) of this section) is 

limited to 14 days. It remains within the 

OTP practitioner’s discretion to 

determine the number of take-home 

doses up to 14 days, but this 

determination must be based on the 

criteria listed in paragraph (i)(2) of this 

section. The rationale underlying the 

decision to provide unsupervised doses 

of methadone must be documented in 

the patient’s clinical record, consistent 

with paragraph (g)(2) of this section. 

(iii) From 31 days of treatment, the 

take-home supply (beyond that of 

paragraph (i)(1) of this section) provided 

to a patient is not to exceed 28 days. It 

remains within the OTP practitioner’s 

discretion to determine the number of 

take-home doses up to 28 days, but this 

determination must be based on the 

criteria listed in paragraph (i)(2) of this 

section. The rationale underlying the 

decision to provide unsupervised doses 

of methadone must be documented in 

the patient’s clinical record, consistent 

with paragraph (g)(2) of this section. 

(4) OTPs must maintain current 

procedures adequate to identify the theft 

or diversion of take-home medications, 

including labeling containers with the 

OTP’s name, address, and telephone 

number. Programs also must ensure that 

each individual take-home dose is 

packaged in a manner that is designed 

to reduce the risk of accidental 

ingestion, including child-proof 

containers (see Poison Prevention 

Packaging Act, Pub. L. 91–601 (15 

U.S.C. 1471 et seq.)). Programs must 

provide education to each patient on: 

Safely transporting medication from the 

OTP to their place of residence; and the 

safe storage of take-home doses at the 

individual’s place of residence, 

including child and household safety 

precautions. The provision of this 

education should be documented in the 

patient’s clinical record. 

(j) Interim treatment. (1) The program 

sponsor of an OTP may admit an 

individual, who is eligible for admission 

to comprehensive treatment, into 

interim treatment if comprehensive 

services are not readily available within 

a reasonable geographic area and within 

14 days of the individual’s seeking 

treatment. At least two drug tests shall 

be obtained from patients during the 

maximum of 180 days permitted for 

interim treatment. A program shall 

establish and follow reasonable criteria 

for establishing priorities for moving 

patients from interim to comprehensive 

treatment. These transition criteria shall 

be in writing and shall include, at a 

minimum, prioritization of pregnant 

patients in admitting patients to interim 

treatment and from interim to 

comprehensive treatment. Interim 

treatment shall be provided in a manner 

consistent with all applicable Federal 

and State laws, including sections 1923, 

1927(a), and 1976 of the Public Health 

Service Act (21 U.S.C. 300x–23, 300x– 

27(a), and 300y–11). 

(2) The program shall notify the 

SOTA when a patient begins interim 

treatment, when a patient leaves interim 

treatment, and before the date of transfer 

to comprehensive services, and shall 

document such notifications. 

(3) The Secretary may revoke the 

interim authorization for programs that 

fail to comply with the provisions of 

this paragraph (j). Likewise, the 

Secretary will consider revoking the 

interim authorization of a program if the 

State in which the program operates is 

not in compliance with the provisions 

of § 8.11(h). 

(4) All requirements for 

comprehensive treatment apply to 

interim treatment with the following 

exceptions: 

(i) A primary counselor is not 

required to be assigned to the patient, 

but crisis services, including shelter 

support, should be available; 

(ii) Interim treatment cannot be 

provided for longer than 180 days in 

any 12-month period; 

(iii) By day 120, a plan for continuing 

treatment beyond 180 days must be 

created, and documented in the 

patient’s clinical record; and 

(iv) Formal counseling, vocational 

training, employment, economic, legal, 

educational, and other recovery support 

services described in paragraphs (f)(4) 

and (f)(5)(i) and (iii) of this section are 

not required to be offered to the patient. 

However, information pertaining to 

locally available, community-based 

resources for ancillary services should 

be made available to individual patients 

in interim treatment. 

§ 8.13 Revocation of accreditation and 

Accreditation Body approval. 

(a) The Secretary’s action following 

revocation of accreditation. If an 

Accreditation Body revokes an OTP’s 

accreditation, the Secretary may 

conduct an investigation into the 

reasons for the revocation. Following 

such investigation, the Secretary may 

determine that the OTP’s certification 

should no longer be in effect, at which 

time the Secretary will initiate 

procedures to revoke the program’s 

certification in accordance with § 8.14. 

Alternatively, the Secretary may 

determine that another action or 

combination of actions would better 

serve the public health, including the 

establishment and implementation of a 

corrective plan of action that will permit 

the certification to continue in effect 

while the OTP seeks reaccreditation. 

(b) Accreditation Body approval. (1) If 

the Secretary withdraws the approval of 

an Accreditation Body under § 8.6, the 

certifications of OTPs accredited by 

such Body shall remain in effect for a 

period of 1 year after the date of 

withdrawal of approval of the 

Accreditation Body, unless the 

Secretary determines that to protect 

public health or safety, or because the 

Accreditation Body fraudulently 

accredited treatment programs, the 

certifications of some or all of the 

programs should be revoked or 

suspended or that a shorter time period 

should be established for the 

certifications to remain in effect. The 

Secretary may extend the time in which 

a certification remains in effect under 

this paragraph (b)(1) on a case-by-case 

basis. 

(2) Within 1 year from the date of 

withdrawal of approval of an 

Accreditation Body, or within any 

shorter period of time established by the 

Secretary, OTPs currently accredited by 

the Accreditation Body must obtain 

accreditation from another 

Accreditation Body. The Secretary may 

extend the time period for obtaining 

reaccreditation on a case-by-case basis. 

§ 8.14 Suspension or revocation of 

certification. 

(a) Revocation. Except as provided in 

paragraph (b) of this section, the 

Secretary may revoke the certification of 

an OTP if the Secretary finds, after 

providing the program sponsor with 

notice and an opportunity for a hearing 

in accordance with this subpart, that the 

program sponsor, or any employee of 

the OTP: 

(1) Has been found to have engaged in 

misrepresentation in obtaining the 

certification; 

(2) Has failed to comply with the 

Federal Opioid Use Disorder treatment 

standards in any respect; 

(3) Has failed to comply with 

reasonable requests from the Secretary 

or from an Accreditation Body for 

records, information, reports, or 

materials that are necessary to 

determine the continued eligibility of 

the OTP for certification or continued 

compliance with the Federal Opioid Use 

Disorder treatment standards; or 

(4) Has refused a reasonable request of 

a duly designated inspector, Drug 

Enforcement Administration (DEA) 

Inspector, State Inspector, or 

Accreditation Body representative for 

permission to inspect the program or the 

program’s operations or its records. 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7561 

(b) Suspension. Whenever the 

Secretary has reason to believe that 

revocation may be required and that 

immediate action is necessary to protect 

public health or safety, the Secretary 

may immediately suspend the 

certification of an OTP, and notify the 

Attorney General that the OTP’s 

registration should be suspended, before 

holding a hearing under this subpart. 

The Secretary may immediately 

suspend as well as propose revocation 

of the certification of an OTP before 

holding a hearing under this subpart if 

the Secretary makes a finding described 

in paragraph (a) of this section and also 

determines that: 

(1) The failure to comply with the 

Federal Opioid Use Disorder treatment 

standards presents an imminent danger 

to the public health or safety; 

(2) The refusal to permit inspection 

makes immediate suspension necessary; 

or 

(3) There is reason to believe that the 

failure to comply with the Federal 

Opioid Use Disorder treatment 

standards was intentional or was 

associated with fraud. 

(c) Written notification. In the event 

that the Secretary suspends the 

certification of an OTP in accordance 

with paragraph (b) of this section or 

proposes to revoke the certification of 

an OTP in accordance with paragraph 

(a) of this section, the Secretary shall 

promptly provide the sponsor of the 

OTP with written notice of the 

suspension or proposed revocation by 

facsimile transmission, personal service, 

commercial overnight delivery service, 

or certified mail, return receipt 

requested. Such notice shall state the 

reasons for the action, state that the OTP 

may seek review of the action in 

accordance with the procedures in this 

subpart, and identify the reviewing 

official to whom a written request for 

review may be submitted. 

(d) Procedure. (1) If the Secretary 

suspends certification in accordance 

with paragraph (b) of this section: 

(i) The Secretary will immediately 

notify DEA that the OTP’s registration 

should be suspended under 21 U.S.C. 

824(d); and 

(ii) the Secretary will provide an 

opportunity for a hearing under this 

subpart. 

(2) Suspension of certification under 

paragraph (b) of this section shall 

remain in effect until the agency 

determines that: 

(i) The basis for the suspension 

cannot be substantiated; 

(ii) Violations of required standards 

have been corrected to the agency’s 

satisfaction; or 

(iii) The OTP’s certification shall be 

revoked. 

§ 8.15 Forms. 

(a) SMA–162—Application for 

Certification to Use Medications for 

Opioid Use Disorder. 

(b) SMA–163—Application for 

Becoming an Accreditation Body under 

§ 8.3. 

Subpart D—Procedures for Informal 

Review of Suspension or Proposed 

Revocation of OTP Certification, and of 

Adverse Action Regarding Withdrawal 

of Approval of an Accreditation Body 

§ 8.21 Applicability. 

The procedures in this subpart apply 

when: 

(a) The Secretary has notified an OTP 

in writing that its certification under the 

regulations in subpart B of this part has 

been suspended or that the Secretary 

proposes to revoke the certification; and 

(b) The OTP has, within 30 days of 

the date of the notification or within 3 

days of the date of the notification when 

seeking an expedited review of a 

suspension, requested in writing to the 

reviewing official, an opportunity for an 

informal review of the suspension or 

proposed revocation. 

(c) The Secretary has notified an 

Accreditation Body of an adverse action 

taken regarding withdrawal of approval 

of the Accreditation Body under the 

regulations in subpart A of this part; and 

(d) The Accreditation Body has, 

within 30 days of the date of the 

notification, requested in writing an 

opportunity for a review of the adverse 

action. 

§ 8.22 Definitions. 

The following definitions apply to 

this subpart: 

Appellant means: 

(1) The OTP which has been notified 

of its suspension or proposed revocation 

of its certification under the regulations 

of this part and has requested a review 

of the suspension or proposed 

revocation; or 

(2) The Accreditation Body which has 

been notified of adverse action 

regarding withdrawal of approval under 

the regulations of this subpart and has 

requested a review of the adverse action. 

Respondent means SAMHSA. 

Reviewing official means the person 

or persons designated by the Secretary 

who will informally review the 

suspension or proposed revocation. The 

reviewing official may be assisted by 

one or more Department of Health and 

Human Services (HHS) officers or 

employees or consultants in assessing 

and weighing the scientific and 

technical evidence and other 

information submitted by the appellant 

and respondent on the reasons for the 

suspension and proposed revocation. 

§ 8.23 Limitation on issues subject to 

review. 

The scope of this informal review 

shall be limited to the facts relevant to 

any suspension, or proposed revocation, 

or adverse action, the necessary 

interpretations of the facts, the 

regulations in this subpart, and other 

relevant law. 

§ 8.24 Specifying who represents the 

parties. 

The appellant’s request for an 

informal review shall specify the name, 

address, and phone number of the 

appellant’s representative. In its first 

written submission to the reviewing 

official, the respondent shall specify the 

name, address, and phone number of 

the respondent’s representative. 

§ 8.25 Informal review and the reviewing 

official’s response. 

(a) Request for review. Within 30 days 

of the date of the notice of the 

suspension or proposed revocation, the 

appellant must submit a written request 

to the reviewing official seeking review, 

unless some other time period is agreed 

to by the parties. A copy must also be 

sent to the respondent. The request for 

review must include a copy of the 

notice of suspension, proposed 

revocation, or adverse action, a brief 

statement of why the decision to 

suspend, propose revocation, or take an 

adverse action is incorrect, and the 

appellant’s request for an oral 

presentation, if desired. 

(b) Acknowledgment. Within 5 days 

after receiving the request for review, 

the reviewing official will send an 

acknowledgment and advise the 

appellant of the next steps. The 

reviewing official will also send a copy 

of the acknowledgment to the 

respondent. 

§ 8.26 Preparation of the review file and 

written arguments. 

The appellant and the respondent 

each participate in developing the file 

for the reviewing official and in 

submitting written arguments. The 

procedures for development of the 

review file and submission of written 

argument are: 

(a) Appellant’s documents and brief. 

Within 30 days after receiving the 

acknowledgment of the request for 

review, the appellant shall submit to the 

reviewing official the following (with a 

copy to the respondent): 

(1) A review file containing the 

documents supporting appellant’s 


khammond on DSKJM1Z7X2PROD with RULES4
7562 Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 

argument, tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining why 

respondent’s decision to suspend or 

propose revocation of appellant’s 

certification or to take adverse action 

regarding withdrawal of approval of the 

Accreditation Body is incorrect 

(appellant’s brief). 

(b) Respondent’s documents and 

brief. Within 30 days after receiving a 

copy of the acknowledgment of the 

request for review, the respondent shall 

submit to the reviewing official the 

following (with a copy to the appellant): 

(1) A review file containing 

documents supporting respondent’s 

decision to suspend or revoke 

appellant’s certification, or approval as 

an Accreditation Body, tabbed and 

organized chronologically, and 

accompanied by an index identifying 

each document. Only essential 

documents should be submitted to the 

reviewing official. 

(2) A written statement, not exceeding 

20 double-spaced pages in length, 

explaining the basis for suspension, 

proposed revocation, or adverse action 

(respondent’s brief). 

(c) Reply briefs. Within 10 days after 

receiving the opposing party’s 

submission, or 20 days after receiving 

acknowledgment of the request for 

review, whichever is later, each party 

may submit a short reply not to exceed 

10 double-spaced pages. 

(d) Cooperative efforts. Whenever 

feasible, the parties should attempt to 

develop a joint review file. 

(e) Excessive documentation. The 

reviewing official may take any 

appropriate steps to reduce excessive 

documentation, including the return of 

or refusal to consider documentation 

found to be irrelevant, redundant, or 

unnecessary. 

(f) Discovery. The use of 

interrogatories, depositions, and other 

forms of discovery shall not be allowed. 

§ 8.27 Opportunity for oral presentation. 

(a) Electing oral presentation. If an 

opportunity for an oral presentation is 

desired, the appellant shall request it at 

the time it submits its written request 

for review to the reviewing official. The 

reviewing official will grant the request 

if the official determines that the 

decision-making process will be 

substantially aided by oral presentations 

and arguments. The reviewing official 

may also provide for an oral 

presentation at the official’s own 

initiative or at the request of the 

respondent. 

(b) Presiding official. The reviewing 

official or designee will be the presiding 

official responsible for managing the 

oral presentations. 

(c) Preliminary conference. The 

presiding official may hold a prehearing 

conference (usually a telephone 

conference call) to consider any of the 

following: Simplifying and clarifying 

issues; stipulations and admissions; 

limitations on evidence and witnesses 

that will be presented at the hearing; 

time allotted for each witness and the 

hearing altogether; scheduling the 

hearing; and any other matter that will 

assist in the review process. Normally, 

this conference will be conducted 

informally and off the record; however, 

the presiding official may, at the 

presiding official’s discretion, produce a 

written document summarizing the 

conference or transcribe the conference. 

(d) Time and place of oral 

presentation. The presiding official will 

attempt to schedule the oral 

presentation within 45 days of the date 

appellant’s request for review is 

received or within 15 days of 

submission of the last reply brief, 

whichever is later. The oral presentation 

will be held at a time and place 

determined by the presiding official 

following consultation with the parties. 

(e) Conduct of the oral presentation— 

(1) General. The presiding official is 

responsible for conducting the oral 

presentation. The presiding official may 

be assisted by one or more HHS officers 

or employees or consultants in 

conducting the oral presentation and 

reviewing the evidence. While the oral 

presentation will be kept as informal as 

possible, the presiding official may take 

all necessary steps to ensure an orderly 

proceeding. 

(2) Burden of proof/standard of proof. 

In all cases, the respondent bears the 

burden of proving by a preponderance 

of the evidence that its decision to 

suspend, propose revocation, or take 

adverse action is appropriate. The 

appellant, however, has a responsibility 

to respond to the respondent’s 

allegations with evidence and argument 

to show that the respondent is incorrect. 

(3) Admission of evidence. The rules 

of evidence do not apply, and the 

presiding official will generally admit 

all testimonial evidence unless it is 

clearly irrelevant, immaterial, or unduly 

repetitious. Each party may make an 

opening and closing statement, may 

present witnesses as agreed upon in the 

pre-hearing conference or otherwise, 

and may question the opposing party’s 

witnesses. Since the parties have ample 

opportunity to prepare the review file, 

a party may introduce additional 

documentation during the oral 

presentation only with the permission 

of the presiding official. The presiding 

official may question witnesses directly 

and take such other steps necessary to 

ensure an effective and efficient 

consideration of the evidence, including 

setting time limitations on direct and 

cross-examinations. 

(4) Motions. The presiding official 

may rule on motions including, for 

example, motions to exclude or strike 

redundant or immaterial evidence, 

motions to dismiss the case for 

insufficient evidence, or motions for 

summary judgment. Except for those 

made during the hearing, all motions 

and opposition to motions, including 

argument, must be in writing and be no 

more than 10 double-spaced pages in 

length. The presiding official will set a 

reasonable time for the party opposing 

the motion to reply. 

(5) Transcripts. The presiding official 

shall have the oral presentation 

transcribed. Either party may request a 

copy of the transcript and the requesting 

party shall be responsible for paying for 

its copy of the transcript. 

(f) Obstruction of justice or making of 

false statements. Obstruction of justice 

or the making of false statements by a 

witness or any other person may be the 

basis for a criminal prosecution under 

18 U.S.C. 1001 or 1505. 

(g) Post-hearing procedures. At the 

presiding official’s discretion, the 

presiding official may require or permit 

the parties to submit post-hearing briefs 

or proposed findings and conclusions. 

Each party may submit comments on 

any major prejudicial errors in the 

transcript. 

§ 8.28 Expedited procedures for review of 

immediate suspension. 

(a) Applicability. When the Secretary 

notifies an OTP in writing that its 

certification has been immediately 

suspended, the appellant may request 

an expedited review of the suspension 

and any proposed revocation. The 

appellant must submit this request in 

writing to the reviewing official within 

10 days of the date the OTP received 

notice of the suspension. The request for 

review must include a copy of the 

suspension and any proposed 

revocation, a brief statement of why the 

decision to suspend and propose 

revocation is incorrect, and the 

appellant’s request for an oral 

presentation, if desired. A copy of the 

request for review must also be sent to 

the respondent. 

(b) Reviewing official’s response. As 

soon as practicable after the request for 

review is received, the reviewing official 


khammond on DSKJM1Z7X2PROD with RULES4
Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations 7563 

will send an acknowledgment with a 

copy to the respondent. 

(c) Review file and briefs. Within 10 

days of the date the request for review 

is received, but no later than 2 days 

before an oral presentation, each party 

shall submit to the reviewing official the 

following: 

(1) A review file containing essential 

documents relevant to the review, 

tabbed, indexed, and organized 

chronologically; and 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining the 

party’s position concerning the 

suspension and any proposed 

revocation. No reply brief is permitted. 

(d) Oral presentation. If an oral 

presentation is requested by the 

appellant or otherwise granted by the 

reviewing official in accordance with 

§ 8.27(a), the presiding official will 

attempt to schedule the oral 

presentation within 20 to 30 days of the 

date of appellant’s request for review at 

a time and place determined by the 

presiding official following consultation 

with the parties. The presiding official 

may hold a pre-hearing conference in 

accordance with § 8.27(c) and will 

conduct the oral presentation in 

accordance with the procedures of 

§ 8.27(e), (f), and (g). 

(e) Written decision. The reviewing 

official shall issue a written decision 

upholding or denying the suspension or 

proposed revocation and will attempt to 

issue the decision within 7 to 10 days 

of the date of the oral presentation or 

within 3 days of the date on which the 

transcript is received or the date of the 

last submission by either party, 

whichever is later. All other provisions 

set forth in § 8.33 apply. 

(f) Transmission of written 

communications. Because of the 

importance of timeliness for the 

expedited procedures in this section, all 

written communications between the 

parties and between either party and the 

reviewing official shall be sent by 

facsimile transmission, personal service, 

or commercial overnight delivery 

service. 

§ 8.29 Ex parte communications. 

For the purposes of maintaining the 

equity of informal review proceedings, 

except for routine administrative and 

procedural matters or as described in 

§§ 8.22(2) and 8.27(e), a party shall not 

communicate with the reviewing or 

presiding official without notice to the 

other party. 

§ 8.30 Transmission of written 

communications by reviewing official and 

calculation of deadlines. 

(a) Timely review. Because of the 

importance of a timely review, the 

reviewing official should normally 

transmit written communications to 

either party by facsimile transmission, 

personal service, or commercial 

overnight delivery service, or certified 

mail, return receipt requested, in which 

case the date of transmission or day 

following mailing will be considered the 

date of receipt. In the case of 

communications sent by regular mail, 

the date of receipt will be considered 3 

days after the date of mailing. 

(b) Due date. In counting days, 

include Saturdays, Sundays, and 

holidays. However, if a due date falls on 

a Saturday, Sunday, or Federal holiday, 

then the due date is the next Federal 

working day. 

§ 8.31 Authority and responsibilities of the 

reviewing official. 

In addition to any other authority 

specified in this subpart, the reviewing 

official and the presiding official, with 

respect to those authorities involving 

the oral presentation, shall have the 

authority to issue orders; examine 

witnesses; take all steps necessary for 

the conduct of an orderly hearing; rule 

on requests and motions; grant 

extensions of time for good reasons; 

dismiss for failure to meet deadlines or 

other requirements; order the parties to 

submit relevant information or 

witnesses; remand a case for further 

action by the respondent; waive or 

modify the procedures in this subpart in 

a specific case, usually with notice to 

the parties; reconsider a decision of the 

reviewing official where a party 

promptly alleges a clear error of fact or 

law; and to take any other action 

necessary to resolve disputes in 

accordance with the objectives of the 

procedures in this subpart. 

§ 8.32 Administrative record. 

The administrative record of review 

consists of the review file; other 

submissions by the parties; transcripts 

or other records of any meetings, 

conference calls, or oral presentation; 

evidence submitted at the oral 

presentation; and orders and other 

documents issued by the reviewing and 

presiding officials. 

§ 8.33 Written decision. 

(a) Issuance of decision. The 

reviewing official shall issue a written 

decision upholding or denying the 

suspension, proposed revocation, or 

adverse action. The decision will set 

forth the reasons for the decision and 

describe the basis for that decision in 

the record. Furthermore, the reviewing 

official may remand the matter to the 

respondent for such further action as the 

reviewing official deems appropriate. 

(b) Date of decision. The reviewing 

official will attempt to issue the 

decision within 15 days of the date of 

the oral presentation, the date on which 

the transcript is received, or the date of 

the last submission by either party, 

whichever is later. If there is no oral 

presentation, the decision will normally 

be issued within 15 days of the date of 

receipt of the last reply brief. Once 

issued, the reviewing official will 

immediately communicate the decision 

to each party. 

(c) Public notice and communications 

to the Drug Enforcement Administration 

(DEA). (1) If the suspension and 

proposed revocation of OTP 

certification are upheld, the revocation 

of certification will become effective 

immediately and the public will be 

notified by publication of a notice in the 

Federal Register. The Secretary will 

notify DEA within 5 days that the OTP’s 

registration should be revoked. 

(2) If the suspension and proposed 

revocation of OTP certification are 

denied, the revocation will not take 

effect and the suspension will be lifted 

immediately. Public notice will be given 

by publication in the Federal Register. 

The Secretary will notify DEA within 5 

days that the OTP’s registration should 

be restored, if applicable. 

§ 8.34 Court review of final administrative 

action; exhaustion of administrative 

remedies. 

Before any legal action is filed in 

court challenging the suspension, 

proposed revocation, or adverse action, 

respondent shall exhaust administrative 

remedies provided under this subpart, 

unless otherwise provided by Federal 

law. The reviewing official’s decision, 

under § 8.28(e) or § 8.33(a), constitutes 

final agency action as of the date of the 

decision. 

Subpart E [Reserved] 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–01693 Filed 1–31–24; 4:15 pm] 

BILLING CODE 4162–20–P 


khammond on DSKJM1Z7X2PROD with RULES4