0 

TABLE OF CONTENTS

FEDERAL 

GUIDELINES FOR 

OPIOID TREATMENT 

PROGRAMS

January 2015 
FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Acknowledgments 

This publication was prepared for under contract number HHSS28320070053I/HHSS28342003T 

by the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. 

Department of Health and Human Services (HHS). Nichole Washington Smith served as the 

Government Project Officer.

Disclaimer 

The views, opinions, and content expressed herein are the views of the consensus panel members 

and do not necessarily reflect the official position of SAMHSA or HHS. No official support of or 

endorsement by SAMHSA or HHS for these opinions or for the instruments or resources 

described are intended or should be inferred. The guidelines presented should not be considered 

substitutes for individualized client care and treatment decisions. 

Public Domain Notice 

All materials appearing in this volume except those taken directly from copyrighted sources are 

in the public domain and may be reproduced or copied without permission from SAMHSA or 

the authors. Citation of the source is appreciated. However, this publication may not be 

reproduced or distributed for a fee without the specific, written authorization of the Office of 

Communications, SAMHSA, HHS. 

Electronic Access and Copies of Publication 

This publication may be ordered or downloaded from SAMHSA’s Publications Ordering 

Webpage at http://store.samhsa.gov. Or, please call SAMHSA at 1-877-SAMHSA-7 (1-877-

7264727) (English). 

Recommended Citation 

Substance Abuse and Mental Health Services Administration. Federal Guidelines for Opioid 

Treatment Programs. HHS Publication No. (SMA) XX-XXXX. Rockville, MD: Substance 

Abuse and Mental Health Services Administration, 2015. 

Originating Office 

Center for Substance Abuse Treatment, Division of Pharmacologic Therapies for the Substance 

Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 

20857. 

HHS Publication No. (SMA) PEP15-FEDGUIDEOTP First Printed 2015 
TABLE OF CONTENTS 1

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................................................. 1

INTRODUCTION..................................................................................................................... 4

Guideline Development Process.................................................................................................................................... 5

Differences between 2007 and 2015 Guidelines...........................................................................................................6

Format Highlights .......................................................................................................................................................... 7

FEDERAL OPIOID TREATMENT STANDARDS............................................................................ 8

Telemedicine ................................................................................................................................................................. 8

Administrative Organization and Responsibilities of Individual Practitioners.............................................................10

Program Sponsor and Medical Director ......................................................................................................................10

Facility Management...................................................................................................................................................12

Medication Unit...........................................................................................................................................................12

Human Resources Management ................................................................................................................................. 13

Risk Management .......................................................................................................................................................13

Patient and Staff Emergencies................................................................................................................................13

Program Emergencies.............................................................................................................................................14

Events that Require Immediate Response and Investigation .................................................................................14

Continuous Quality Improvement...............................................................................................................................15

Community Relations and Education ..........................................................................................................................16

Voluntary and Involuntary Program Closure ...............................................................................................................17

Diversion Control.........................................................................................................................................................17

Professional Staff Credentials and Development........................................................................................................20

Patient Admission Criteria ...........................................................................................................................................21

Informed Consent...................................................................................................................................................23

Medically Supervised Withdrawal ...............................................................................................................................24

Detoxification..........................................................................................................................................................24

Voluntary Medically Supervised Withdrawal..........................................................................................................25

Withdrawal against Medical Advice .......................................................................................................................26
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Involuntary Withdrawal from Treatment ...............................................................................................................26

Required Services ........................................................................................................................................................28

Initial Medical Examination Services...........................................................................................................................29

Pregnant and Postpartum Patients .............................................................................................................................30

Neonatal Abstinence Syndrome ..................................................................................................................................32

Clinical Assessment, Treatment Planning, and Evaluation of Patient Progress in Treatment.....................................33

Assessment and Treatment Planning .....................................................................................................................33

Evaluation ...............................................................................................................................................................34

HIV and Hepatitis....................................................................................................................................................35

Mental Health Disorders.........................................................................................................................................36

Trauma....................................................................................................................................................................37

Tobacco Use Disorders ...........................................................................................................................................37

Alcohol Use Disorders.............................................................................................................................................37

Benzodiazepine Use................................................................................................................................................38

Chronic Pain............................................................................................................................................................38

Aftercare Planning ..................................................................................................................................................39

Recovery Oriented Systems of Care ............................................................................................................................39

Cultural Competency ..............................................................................................................................................40

HIV Prevention........................................................................................................................................................41

HCV Prevention.......................................................................................................................................................41

Treatment of Adolescents ......................................................................................................................................41

Criminal Justice Issues ............................................................................................................................................41

Women in Treatment .............................................................................................................................................41

Family Involvement.................................................................................................................................................42

Alternative Therapies..............................................................................................................................................42

Orientation to Treatment .......................................................................................................................................42

Substance Abuse Counseling ..................................................................................................................................43

Twelve-Step or Other Mutual-Help Groups............................................................................................................43

Counseling for HIV, Hepatitis, and Other Infectious Diseases................................................................................43

Medical Services .....................................................................................................................................................43

Testing and Screening for Drug Use ............................................................................................................................44

Recordkeeping and Documentation............................................................................................................................45

Patient Records.......................................................................................................................................................46

Records for the Storage, Dispensing, and Administration of Opioid Medication...................................................48

Multiple Program Enrollment Prevention...............................................................................................................48

Guidelines for Therapeutic Dosage and Administration..............................................................................................48

.....................................................................................................................................................................................49

Pharmacotherapy ........................................................................................................................................................50

General Dosage Principles ......................................................................................................................................50

Unsupervised Approved Use (Take-Home) of Medication..........................................................................................53
TABLE OF CONTENTS 3

Medication Security ................................................................................................................................................56

Provision of Medication to Patients Who Are Incarcerated, in Residential Treatment, Medically Compromised, 

or Homebound........................................................................................................................................................56

Interim Maintenance...................................................................................................................................................57

Exemptions..................................................................................................................................................................58

Exception Request and Record of Justification (SMA-168) Form ...........................................................................58

Exception Request for Variation from Detoxification Standards............................................................................59

Exception Request for Other Reasons....................................................................................................................60

Submit an SMA-168 Exception Request .................................................................................................................60

APPENDIX A. REFERENCES ................................................................................................... 61

APPENDIX B. GUIDELINES PANEL ......................................................................................... 63

APPENDIX C. FREQUENTLY ASKED QUESTIONS..................................................................... 65

Communication with SAMHSA ....................................................................................................................................65

Take-Home Privileges..................................................................................................................................................69

Detoxification Programs..............................................................................................................................................71

Treatment....................................................................................................................................................................72

Medication...................................................................................................................................................................74

Drug Testing................................................................................................................................................................. 75

APPENDIX D. SAMPLES OF STANDARD FORMS ..................................................................... 76

Example of Standard Consent to Opioid Maintenance Treatment .............................................................................76

Example of Medication Chain-of-Custody Record.......................................................................................................77

APPENDIX E. PROGRAM RESPONSIBILITIES .......................................................................... 78
INTRODUCTION 4

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

INTRODUCTION

The Federal Guidelines for Opioid Treatment Programs (Guidelines) describe the Substance 

Abuse and Mental Health Services Administration’s (SAMHSA) expectation of how the federal 

opioid treatment standards found in Title 42 of the Code of Federal Regulations Part 8 (42 CFR § 

8) are to be satisfied by opioid treatment programs (OTPs). Under these federal regulations, 

OTPs are required to have current valid accreditation status, SAMHSA certification, and Drug 

Enforcement Administration (DEA) registration before they are able to administer or dispense 

opioid drugs for the treatment of opioid addiction. As stated in 42 CFR § 8.12(i)(2), these 

regulations apply to “opioid agonist treatment medications that are approved by the Food and 

Drug Administration.” Currently, these drugs are methadone and pharmaceutical products 

containing buprenorphine, hereafter referred to as buprenorphine. The regulations apply equally 

to both of these medications, with the only difference being the time and treatment requirement

for unsupervised dosing spelled out in 42 CFR § 8.12(i)(3). Other pharmacotherapies may be 

provided in a manner consistent with the best medical practices for each drug. For example, the 

use of naltrexone has a place in OTPs but is not subject to these regulations. 

The regulations describe a minimum acceptable standard for the operation of OTPs. They are 

not intended to provide clinical or medical guidelines but rather to assure, to the greatest extent 

possible, the safety of both the patient and the public. Given that OTPs provide a medical 

service, the care delivered should be comparable to the medical care provided in other settings. 

These guidelines are but one piece of what is necessary to provide comprehensive patientcentered care. They are not intended to take the place the professional judgment of healthcare

providers and are not professional standards of care. 

SAMHSA- approved best practices for methadone can be found in the Treatment Improvement 

Protocol 43 (TIP 43): Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment 

Programs (http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). For SAMHSA’s best 

practices for the use of buprenorphine, refer to TIP 40: Clinical Guidelines for the Use of 

Buprenorphine in the Treatment of Opioid Addiction

(http://www.ncbi.nlm.nih.gov/books/NBK64245/pdf/TOC.pdf).

In addition, SAMHSA partnered with the National Institute on Drug Abuse (NIDA) to provide 

guidance for the use of medication-assisted treatment with extended-release injectable naltrexone 

for the treatment of an opioid use disorder. The Clinical Use of Extended-Release Injectable 

Naltrexone in the Treatment of Opioid Use Disorder: A Brief Guide can be accessed at 

http://store.samhsa.gov/shin/content/SMA14-4892/SMA14-4892.pdf. This brief guide includes a 

summary of the key differences between extended-release injectable naltrexone, methadone, and 

buprenorphine. It covers key information on assessing the patient’s need for treatment, initiating 

medication-assisted treatment, monitoring patient progress and adjusting the treatment plan, and 

deciding whether and when to end medication-assisted treatment. 

Although the federal regulations have not changed since their original adoption in 2001, the realworld issues of opioid use disorders, the delivery of healthcare, and the problems impacting the 
INTRODUCTION 5

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

health of the public change continuously. By updating the Guidelines periodically, SAMHSA is 

not reinterpreting the regulations, but rather is expressing how these regulations may be applied

in the context of clinical and medical issues confronted by OTPs today. 

Compliance with the regulations is assessed by SAMHSA-approved and -monitored accrediting 

organizations. The determination of compliance is made by these accrediting organizations 

based on the guidelines put forth in this document and informed by the recognized best-practices 

of medicine and healthcare delivery. While these guidelines address only 42 CFR § 8.12, all of 

42 CFR § 8 contains information of interest to OTPs. In some cases, it is necessary to be aware 

of regulations from other titles or parts of the Code of Federal Regulations in order to understand 

the intent of 42 CFR § 8.12. These other regulations are cited in this document where needed. 

SAMHSA encourages persons interested in OTP operation to familiarize themselves with all of 

42 CFR § 8 by accessing http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&tpl=/ecfrbrowse/Title42/42cfr8_main_02.tpl. 

GUIDELINE DEVELOPMENT PROCESS

Between 1996 and 1999, SAMHSA followed a Treatment Improvement Protocol-type process

and developed federal guidelines to assist accreditation organizations with developing standards 

in conformance with those set forth in 42 CFR § 8.12. This process included convening two 

expert panels to provide input into what the Guidelines should cover, conducting field reviews, 

and obtaining clearances from other federal agencies and the Office of Management and Budget. 

As a result of this process, SAMHSA published the first edition of the Federal Guidelines for the 

Accreditation of Opioid Treatment Programs in 2001. Then, in 2007, SAMHSA published an 

updated edition that reflected changes in medication-assisted treatment policies and evidencebased practices that occurred over the years. 

As policies, research, and practices in medication-assisted treatment continued to evolve, 

SAMHSA once again recognized the need to revise the guidelines. In 2012, a stakeholder panel 

was convened and charged with revisiting what is called the Federal Guidelines for the 

Accreditation of Opioid Treatment Programs in light of new research findings; advancements in 

the field; and state-of-the-art, evidence-based practices. This panel was composed of federal and

state regulatory authorities, addiction treatment providers and counselors, accreditation 

organizations, patient advocates, and others with knowledge and expertise in the following 

content areas:

• Recent developments in opioid addiction treatment. 

• New buprenorphine take-home dose regulation. 

• The prevention and treatment of infectious diseases, such as the human immunodeficiency 

virus (HIV) and hepatitis viruses. 

• Best practices in addiction treatment. 

• Use of all addiction treatment medications. 

• New addiction pharmacotherapies (buprenorphine/naloxone and injectable naltrexone) 
INTRODUCTION 6

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• The growing problem of prescription drug abuse. 

• Issues relating to diversion control. 

• Medication for unsupervised or take-home use. 

• Methadone-associated mortality. 

• Planning and acting in emergencies. 

• Detoxification (medically supervised withdrawal) from drugs of abuse. 

• Medically supervised withdrawal from opioids. 

• Community or state resistance to medication-assisted treatment. 

• Cardiac complications. 

• Management of co-occurring disorders, including chronic pain. 

• Third-party reimbursement. 

• Physician and staff education. 

• Office-based opioid treatment (OBOT). 

• Approval of ER injectable naltrexone for opioid dependence. 

Between 2012 and 2014, SAMHSA sought the input of panel members, other federal and state 

agency staff, and members of the public for the third edition of the guidelines, entitled Federal

Guidelines for Opioid Treatment Programs (Guidelines). The revised Guidelines were edited, 

organized, and formatted in accordance with the Federal Plain Language Guidelines. In 2013, 

the draft Guidelines were published in the Federal Record for public comment. These comments 

were then reviewed and addressed. 

DIFFERENCES BETWEEN 2007 AND 2015 GUIDELINES

There are several significant differences in content between the 2007 and 2015 Guidelines. 

First, the 2015 Guidelines reflect the obligation of OTPs to deliver care consistent with the 

patient-centered, integrated, and recovery oriented standards of addiction treatment and medical 

care in general.

Also provided herein is guidance regarding the implementation of technological and other 

changes within healthcare. This information is provided throughout the document in the context 

of the regulation most impacted by these changes. The subjects included are: 

• The electronic health record. 

• Prescription drug monitoring programs (PDMPs). 

• Nursing scope of practice. 

• The role of non-physician authorized prescribers. 

• Telemedicine. 

• Benzodiazepine misuse in the context of opioid agonist therapy. 

• The rule that went into effect January 7, 2013, removing the “time in treatment” requirement 

for patients receiving buprenorphine for take-home use from OTPs. 
INTRODUCTION 7

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

FORMAT HIGHLIGHTS

This document is organized so that the corresponding regulation in 42 CFR § 8.12 is cited in a 

shaded text box that follows a related subject heading. Programs should contact CSAT’s 

Division of Pharmacologic Therapies (DPT) at otp-extranet@opioid.samhsa.gov or via the 

SAMHSA website at www.samhsa.gov should they have any questions regarding the 

information in this document or OTP-related issues not covered here. 
FEDERAL OPIOID TREATMENT STANDARDS 8

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

FEDERAL OPIOID 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.

SAMHSA’s federal opioid treatment standards, found in 42 CFR § 8.12

(http://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=0d945f6e5f6068b536698ccc72159bc8&r=PART&n=42y1.0.1.1.1

0#se42.1.8_112), became effective in May 2001. As stated in 42 CFR § 8.12(a), OTPs are 

required to have current valid accreditation status and SAMHSA certification before they are 

able to dispense opioid drugs for the treatment of opioid addiction. 

TELEMEDICINE

Compliance with various aspects of the regulations contained in 42 CFR § 8.12 is impacted in a 

general way by larger trends in healthcare delivery. One of these is the use of technology. 

Digital communications, including telemedicine, telehealth, and e-therapy, both enriches and 

complicates providing treatment that is in compliance with federal regulations. The terms 

telemedicine, telehealth, and e-therapy often are used interchangeably. The Institute of Medicine 

defines telemedicine as the “use of medical information exchanged from one site to another via 

electronic communications to improve patient health status.” As a result of telemedicine, 

individuals unable to avail or who lack access to medication-assisted treatment may receive 

appropriate services. The Center for Medicare and Medicaid Services (CMS) provides the 

following guidance with regard to telemedicine. 

• Medicaid guidelines require all providers to practice within the scope of their state practice.

Some states have enacted legislation that requires providers using telemedicine technology

across state lines to have a valid state license in the state where the patient is located. Any

such requirements or restrictions placed by the state are binding under current Medicaid

rules.

• For the purposes of Medicare and Medicaid, telemedicine services must be conducted via an

interactive audio and video telecommunications system that permits real-time

communication between the healthcare provider at the distant site and the patient at the

originating site. An originating site is the location of the patient at the time the service being

furnished via a telecommunications system occurs.

• The full CMS guidance on telemedicine can be accessed at

http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/DeliverySystems/Telemedicine.html.
FEDERAL OPIOID TREATMENT STANDARDS 9

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Meanwhile, a number of states are adopting requirements that those practicing telemedicine 

comply with standards used for face-to-face services, have formalized policies in place, or 

acquire certification. The Joint Commission and other accrediting bodies have established 

certification for telemedicine providers including providers of mental health and substance abuse 

treatment services. The National Association of State Alcohol and Drug Abuse Directors 

supported this concept in its report entitled Telehealth in State Substance Use Disorder (SUD) 

Services. For further information from CMS about telemedicine, access 

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNProducts/downloads/telehealthsrvcsfctsht.pdf. 

OTPs are advised to proceed thoughtfully and with full understanding of requirements 

established by the state or health professional licensing boards. Exceptional attention needs to be 

paid to data security and privacy in this evolving field. Telemedicine services should, under no 

circumstances, expand the scope of practice of a healthcare professional or permit practice in a 

jurisdiction (the location of the patient) where the provider is not licensed. Also, telemedicine 

may not substitute for a physical examination when one is needed, although it may be used to 

support the decision making of a physician when a provider qualified to conduct physical 

examinations and make diagnoses is physically located with the patient.

An additional consideration regarding telemedicine in the context of OTPs is the possible 

provision of buprenorphine under DATA 2000. When buprenorphine is administered or 

dispensed for a patient enrolled in the OTP, the provision of care via telemedicine is not 

impacted by the Controlled Substances Act (CSA) (28 USC § 802) 

(http://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm), which defines the limits on the use of 

telemedicine in the context of providing a valid prescription for a controlled substance. When 

patients are receiving buprenorphine for an opioid use disorder from a physician who has a 

waiver under the DATA 2000, policies must be in place to assure compliance with the CSA. 

The restrictions may be reviewed by accessing 21 USC § 802. There are no restrictions or 

limitations on the use or administration of extended release injectable naltrexone (ERIN). For 

more information, please refer to An Introduction to Extended-Release Injectable Naltrexone for 

the Treatment of People With Opioid Dependence at

https://store.samhsa.gov/shin/content/SMA12-4682/SMA12-4682.pdf. 

E-therapy means using electronic media and information technologies to provide services for 

patients in different locations. It is used by skilled and knowledgeable professionals (e.g., 

counselors, therapists) to address a variety of individual, familial, and social issues. E-therapy 

can (1) include a range of services, including screening, assessment, primary treatment, and after 

care; (2) provide greater access to treatment services for populations who rely extensively on 

electronic devices (i.e., adolescents and young adults); (3) help people access treatment services 

who traditionally would not seek services because of barriers related to geography, shame and 

guilt, stigma, or other issues; and 4) be provided as a sole treatment modality or in combination 

with other treatment modalities, like traditional or existing treatments. 
FEDERAL OPIOID TREATMENT STANDARDS 10

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

To guide programs in the development and implementation of substance abuse treatment services 

via technology, SAMHSA published Consideration for the Provision of E-Therapy, which can 

be found at http://store.samhsa.gov/shin/content/SMA09-4450/SMA09-4450.pdf. 

ADMINISTRATIVE ORGANIZATION AND RESPONSIBILITIES OF INDIVIDUAL PRACTITIONERS

b) Administrative and organizational structure. 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 and any 

regulations regarding the use of opioid agonist treatment medications in the treatment of 

opioid addiction, which may be promulgated in the future. The medical director shall 

assume responsibility for administering all medical services performed by the OTP. In 

addition, the medical director shall be responsible for ensuring that the OTP complies with 

all applicable Federal, State, and local laws and regulations.

An OTP’s administrative organization serves to support the safe and effective delivery of 

medication-assisted treatment and assures compliance with the requirements, laws, and 

regulations of the Department of Health and Human Services (HHS), the Drug Enforcement 

Administration (DEA), and the states. Typically, an OTP’s administrative organization 

comprises, at a minimum, a program sponsor, program director or manager, and a medical 

director. Within the organizational structure, it is essential for physicians to have authority over 

the medical and nursing aspects of medication-assisted treatment and to retain autonomy so as to 

ensure ongoing decisions are individualized according to the needs of each patient, the clinical 

course of treatment, and the standards of medical practice. 

PROGRAM SPONSOR AND MEDICAL DIRECTOR

42 CFR § 8.2 defines the roles and responsibilities of the medical director and the program 

sponsor as follows: 

• “Medical director means a physician, licensed to practice medicine in the jurisdiction in 

which the opioid treatment program is located, who assumes responsibility for administering 

all medical services performed by the program, either by performing them directly or by 

delegating specific responsibility to authorized program physicians and healthcare 

professionals functioning under the medical director’s direct supervision.” 

• “Program sponsor means the person named in the application for certification described in 

42 CFR § 8.11(b) is responsible for the operation of the opioid treatment program and who 

assumes responsibility for all its employees, including any practitioners, agents, or other 

persons providing medical, rehabilitative, or counseling services at the program or any of its 
FEDERAL OPIOID TREATMENT STANDARDS 11

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

medication units. The program sponsor need not be a licensed physician but shall employ a 

licensed physician for the position of medical director.” 

The program sponsor is the person ultimately responsible for the operation of the program, and 

most importantly, ensuring the program is in continuous compliance with all federal, state, and 

local laws and regulations. If there is a change of program sponsor, SAMHSA requires formal 

notification within 3 weeks of the change. 

While the program sponsor retains the ultimate responsibility for an OTP’s operations, the dayto-day management of the program often is assigned to the program director or manager who

assumes the duties assigned by the program sponsor. It is important to note that the regulations 

do not require OTPs to have program directors or managers on staff nor define the role of a 

program director; therefore, the program sponsor in some OTPs also serves as the program 

director.

The medical director is responsible for monitoring and supervising all medical and nursing 

services provided by the OTP. The medical director should have completed an accredited 

residency training program and have at least 1 year of experience in addiction medicine or 

addiction psychiatry. Board certification in his or her primary medical specialty and in addiction 

psychiatry or addiction medicine is preferred. All OTP physicians are urged to complete the 

training in the use of buprenorphine required by the Drug Addiction Treatment Act 2000 (DATA 

2000), even if they do not plan to provide buprenorphine under office-based opioid treatment 

(OBOT) rules. In some cases, the one individual may be both medical director and program 

sponsor but only a physician may serve as the medical director of an OTP. (See 42 CFR § 8.2.) 

If there is a change of medical director, SAMHSA requires formal notification within 3 weeks of 

the change.

The medical director is responsible for assuring all medical, psychiatric, nursing, pharmacy, 

toxicology, and other services offered at the OTP are conducted in compliance with federal 

regulations at all times. The medical director should be present at the program a sufficient 

number of hours to assure regulatory compliance and carry out those duties specifically assigned 

to the medical director by regulation. The medical director may directly provide the required 

services to the OTP’s patients or assure that the needed services are provided by appropriately 

trained and licensed providers in compliance with federal and state regulation. 

Some aspects of medication-assisted treatment services may be provided by an authorized 

healthcare professional other than a physician such as an advanced practice nurse, physician 

assistant, or advanced-practice pharmacist. It is the responsibility of the OTP to review the 

individual licensing, scope of practice, and supervision requirements of each state with regard to 

the duties of such an authorized healthcare professional within the OTP beyond the federal roles 

and limits spelled out in these Guidelines. 
FEDERAL OPIOID TREATMENT STANDARDS 12

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

FACILITY MANAGEMENT 

Each OTP must have sufficient space and adequate equipment to provide all required services, 

including diagnosis; evaluation; and treatment of other medical, psychiatric, and behavioral 

disorders, if performed onsite. Policies forbidding children in the facility are not acceptable. 

While programs may not be able to provide services for children, every effort should be made to 

provide a safe and supportive environment for parents and their children. 

The facility must:

• Be clean and well maintained, similar to and consistent with facilities for other medical or 

behavioral healthcare.

• Be maintained in full compliance with all relevant safety and environmental codes and be 

able to provide documentation of continuous compliance. 

• Assure patient privacy. Internal controls on privacy are often overlooked in facility design 

and staff-to-patient and patient-to-patient communication. Windowed or open workspaces; a 

cashier located in a public area; untrained security guards; common medication dispensing 

areas; and hallway conversations about treatment plans, failed urinalysis, or psychiatric 

medications are all examples of how patient privacy may be violated. OTPs should take 

measures to prevent or correct such problems, when possible. Attention must also be paid to 

the privacy of electronic patient information. This may include keeping computer screens 

out of view, assigning individual login names for staff, and requiring regular password 

changes. For further discussion of protecting patient privacy in the electronic environment, 

access: http://www.healthit.gov/sites/default/files/smallpracticesecurityguide-1.pdf. 

• Provide services during hours that meet the needs of the overwhelming majority of patients, 

which includes hours outside of the traditional 8:00 a.m. to 5:00 p.m. Monday through Friday 

work schedule. 

• Comply with Occupational Safety and Health Administration (OSHA) workplace health and 

safety standards.

MEDICATION UNIT

According to 42 CFR § 8.11(i)(1), a certified OTP may establish a medication unit or units to 

administer or dispense medication therapy. Such a medication unit must have a separate and 

unique DEA registration. SAMHSA only requires notification via submission of an updated online SMA-162 (http://dpt2.samhsa.gov/sma162/); no additional certification is needed. Such a 

unit is intended to facilitate access to medication-assisted treatment for patients who would 

otherwise have to travel great distances. Other required services must still be provided at the 

certified OTP. Please see the FAQs section in the Guidelines for further instruction.
FEDERAL OPIOID TREATMENT STANDARDS 13

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

The full regulatory language describing medication units can be found in 42 CFR § 8.12

(http://www.ecfr.gov/cgi-bin/textidx?SID=b7de4cc92bf0a4d977929a4978c64e30&node=42:1.0.1.1.10.2.1.1&rgn=div8). 

Medication units are not required to be free-standing entities. For example, a medication unit 

can be located at a hospital or community pharmacy. 

To open a medication unit, a program must submit the online SMA-162, available on 

SAMHSA’s Extranet at http://otp-extranet.samhsa.gov, with all requested attachments and 

signed documents to SAMHSA. In Item 14, “Purpose of Application,” “Medication Unit” must 

be checked off. SAMHSA will process the form and forward it for approval to the DEA, which 

will arrange an inspection. The program also should submit all required materials to the State 

Opioid Treatment Authority (SOTA) to seek state approval, as appropriate. Once approved by 

the DEA, the medication unit will be assigned a new DEA registration number. For further 

information please refer to the FAQs section of the Guidelines. 

HUMAN RESOURCES MANAGEMENT

Each OTP must have an adequate number of physicians; nurses; counselors; recovery coaches; 

and other staff appropriately licensed, trained, and available for the level of care provided as well 

as the acuity and number of patients enrolled. Individual personnel files must be maintained for 

each staff person and are to contain employment application data, date of employment, updated 

licensing and credentialing information, detailed job descriptions, performance evaluations, 

appropriate intramural and extramural training records, and other employment and credentialing 

data deemed appropriate. Great care should be taken in the development of nursing job 

descriptions. For example, registered nurses (RNs) and licensed practical or vocational nurses 

(LPNs) have distinctly different scopes of practice. Of note, LPNs are generally considered 

“dependent practitioners.” (See Professional Staff Credentials and Development section of the 

Guidelines.) 

RISK MANAGEMENT 

Each OTP must provide for patient and staff safety, program emergencies, and adverse events 

that require immediate response and investigation by developing and maintaining effective 

policies and procedures. 

Patient and Staff Emergencies

Facility offices and waiting areas should display the names and telephone number of individuals 

(e.g., physicians, hospitals, emergency medical technicians) who should be contacted in case of 

emergency or utilize 911 or similar local emergency resources. A mechanism to address patient 

medical or psychiatric emergencies occurring outside of program hours of operation must be 

provided. Typically, this includes the establishment of an emergency contact system to obtain 

dosage levels and other pertinent patient information on a 24-hour, 7-days-a-week basis, as 

appropriate under confidentiality regulations. Every patient should be given an identification 
FEDERAL OPIOID TREATMENT STANDARDS 14

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

card that identifies the opioid use disorder pharmacotherapy being administered through the 

OTP. The card also should include the emergency contact information so that appropriate 

clinical information and dosing information can be obtained in an emergency. For additional 

information on emergencies, access 42 CFR § 2.51 (http://www.ecfr.gov/cgi-bin/textidx?SID=07521f1d15ff4661f403ec736facfdb7&node=42:1.0.1.1.2.4.1.1&rgn=div8). 

Policies and procedures must also address safety and security issues for patients and staff. 

Procedures should include a mechanism for reporting untoward incidents to program staff or 

outside agencies including accrediting bodies and the SOTA as appropriate. Staff should be 

trained to recognize and respond preemptively to patients who demonstrate behaviors with the 

potential to escalate to threats or violence or are suggestive of a mental health crisis. Staff 

should be trained and supported to deescalate physical or verbal threats, access mental health 

crisis services on behalf of patients, and secure their own safety and that of other patients in the 

event that a violent or threatening situation cannot be deescalated. Staff should be authorized to 

notify security guards or police when needed. 

Program Emergencies

Each OTP should maintain an up-to-date disaster plan that addresses fire suppression, including 

maintenance of fire extinguishers, fire drills, and emergency evacuation procedures; ensures that 

needed supplies are available in the event of an emergency requiring staff or patients to shelter in 

place, and includes links to community agencies. 

In the event of an emergency leading to temporary closure of a program, an up-to-date plan for 

emergency administration of medications should be maintained. An alternative dosing location 

should be secured in advance because DEA registration of the new location may be required if it 

is not already an OTP. Facilities should have the capability to respond to emergencies on a 24-

hour basis. Designated staff persons should have access to a record of active patients, their 

medication dose, schedule, and last dose administered in order to provide accurate dosing at an 

alternative location. In addition, the plan should include a mechanism for informing patients of 

emergency arrangements, alternative dosing locations; and a procedure for notifying SAMHSA, 

DEA, and state authorities of the situation. To review specific disaster guidance provided by 

SAMHSA, access http://www.dpt.samhsa.gov/pdf/dearColleague/GuidanceKatrina_090905.pdf. 

Events that Require Immediate Response and Investigation 

Each OTP should establish procedures to guard against critical incidents, defined as events that 

could have a negative impact on patients and their family members, the program or staff, or the 

health of the public. This includes events that involve the loss of life or function, any serious 

physical or psychological injury, and medication errors. Critical incidents are also known as 

sentinel events, significant adverse events, and untoward events. Critical incidents should be 

reported to the appropriate federal and state agencies and others according to the program’s 

procedures and any applicable regulatory and accrediting organization requirements. 

Significant incidents or adverse events that may require advance preparation, reporting, 

investigation, or corrective action will vary by program. These events may include accidental 

injury or violence on the premises; medication errors; harm to family members or others from 
FEDERAL OPIOID TREATMENT STANDARDS 15

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

ingesting a patient’s medication; selling drugs on the premises; medication diversion; harassment 

or abuse of patients by staff; unexpected or suspicious deaths; deaths related to overdose or 

medication interactions; or any other injury or death that raises individual, family, community, or 

public concern. 

In case a critical incident occurs, an OTP’s established procedures provide for:

• Full documentation of the incident. 

• Prompt investigation and review of the situation surrounding the incident. 

• Timely and appropriate implementation of corrective action(s).

• Ongoing monitoring of any corrective actions until their effectiveness is established.

CONTINUOUS QUALITY IMPROVEMENT

42 CFR 8.12(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.

The continuous monitoring of an OTP’s policies, procedures, practices, and patient outcomes 

serves to improve operations, customer service, patient satisfaction, and, ultimately, treatment 

outcomes. A continuous quality improvement plan should include, at a minimum:

• A statement of the program’s patient outcome goals. 

• A description of steps to be implemented to achieve patient outcome goals. 

• Provisions for regular and continuous staff education. 

• Up-to-date, individualized staff development plans. 

• Review and recertification of program policies and procedures at least annually.

• Evaluation and modification, if needed, of the program diversion control plan.

• Patient input into program policies and procedures regarding patient and community 

concerns.

• Development, implementation and corrective response to patient satisfaction surveys. 

• Adherence to universal or standard infection control precautions as promulgated by the 

Centers for Disease Control and Prevention (CDC). These standards may be found at: 

http://www.cdc.gov/hai/settings/outpatient/outpatient-care-guidelines.html. 
FEDERAL OPIOID TREATMENT STANDARDS 16

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• Measurement and monitoring of patient treatment outcomes and processes on a regular 

basis—for example, quarterly—to inform quality improvement. Treatment outcomes may 

include patients’: 

− Use of illicit opioids, illegal drugs, marijuana, and the problematic use of alcohol and 

prescription medicines. 

− Criminal activities and involvement with the criminal justice system. 

− Behaviors contributing to the spread of infectious diseases. 

− Quality of life such as physical and mental health and functional status. 

− Retention in treatment.

− Employment. 

− Engagement in recovery support services. 

• Consideration of monitoring an OTP’s progress in adopting a “recovery-oriented systems of 

care” (ROSC) model with an atmosphere of acceptance. For guidance, access Guiding 

Principles and Elements of Recovery-Oriented Systems of Care: What do we know from the 

research?

(http://beta.samhsa.gov/sites/default/files/partnersforrecovery/docs/Guiding_Principles_Whit

epaper.pdf.) 

COMMUNITY RELATIONS AND EDUCATION

Before a new OTP moves into a community or neighborhood and opens its doors to patients, 

there is a strong need to educate all entities affected by the program’s presence, including the 

medical community, neighbors, and those who provide support services. States may have 

specific community relations plan requirements for opening or moving an OTP into a community 

or neighborhood. 

OTPs must have policies and procedures to measure and minimize the negative impact an 

existing or new program may have on a community, promote peaceful coexistence, and plan for 

change and program growth. Such policies and procedures should address: 

• Community need and impact when selecting sites for programs.

• Community input on the potential impact a program may have on a neighborhood. 

• Maintenance of a clean and orderly facility that does not impede pedestrian or traffic flow.

• Identification and maintenance of communication with community leaders for the purpose of 

fostering good community relations. Examples of community leaders are: publicly elected 

representatives; community business associations; local health, substance abuse, and social, 

and/or human service agency directors; business organization leaders; community and health 

planning agency directors; grassroots community organization leaders; local police and law 

enforcement officials; and religious and spiritual leaders.
FEDERAL OPIOID TREATMENT STANDARDS 17

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• Development and implementation of a community relations plan that is specific to the 

configuration and needs of the program within its community and includes but is not limited 

to the following actions: 

− Establish a liaison with community representatives to share information about the 

program, the community, and mutual concerns and issues.

− Identify program personnel who will function as community relations coordinators and 

define the goals and procedures of the community relations plan. 

− Serve as a community resource on substance use and related health and social issues as 

well as promote the benefit of medication-assisted treatment in preserving the public 

health. 

− Solicit community input about medication-assisted treatment and the program’s presence 

in the community. 

− Develop program policies and procedures to effectively address or resolve community 

problems (including patient loitering and medication diversion) and ensure that program 

operations do not affect community life adversely. 

• Document community contacts and community relations efforts and evaluate the 

effectiveness of activities over time in addressing outstanding problems or deficiencies. 

• Develop communication mechanisms that provide interested parties and potential patients 

with general information about the program outside of regular operating hours. 

VOLUNTARY AND INVOLUNTARY PROGRAM CLOSURE

OTPs, through state authorities and other relevant governmental entities, must establish 

procedures that ensure continuity of care for patients in the event of either a voluntary or 

involuntary closure of programs. The plan should include steps for the notification and orderly 

transfer of patients, records, and assets to other programs or practitioners and the procedure for 

securing and maintaining patient records for a specified period of time in accordance with state 

and federal regulations. 

DIVERSION CONTROL

42 CFR 8.12(c) (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 controlled substances from legitimate treatment use and that 

assigns specific responsibility to the medical and administrative staff of the OTP for 

carrying out the diversion control measures and functions described in the DCP.
FEDERAL OPIOID TREATMENT STANDARDS 18

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

An OTP must develop and maintain a diversion control plan (DCP). The goal of a DCP is to 

reduce the scope and significance of diversion and its impact on communities. Each program’s 

DCP should make every effort to balance diversion control against the therapeutic needs of the 

individual patient.

DCPs should address at least four general areas of concern: program environment, dosing and 

take-home medication (take-homes), prevention of multiple program enrollment, and 

prescription medication misuse. 

• Program Environment: Diversion in the program environment can be deterred and detected 

by regular surveillance and the monitoring of areas in and around the program, where 

opportunities for diversion may exist. Some OTPs use video surveillance; however, few rely 

solely on this method. A system of rounds, where security personnel or other staff walk 

around the interior and exterior of the clinic on a regular and periodic basis to observe 

activities at the entrances and in the hallways, adjacent alleys, and parking areas, provides an

opportunity to assess and intervene in suspicious behaviors such as loitering. A visible 

human presence at a program’s location gives community members the opportunity to 

approach staff with concerns and communicates the program’s commitment to assuring a 

safe environment and a positive impact on the surrounding community. It also is 

recommended that OTP staff consult periodically with law enforcement in the surrounding 

community and where patients live to discuss surveillance findings (assuming it will not 

impair any criminal investigation) and the perceived and actual problems encountered. 

Patient involvement in assuring a therapeutic and safe treatment environment is an essential 

part of a DCP. Patient committees can advise on program policies and procedures and how 

they are implemented. Patients can make important contributions to problem solving and 

help balance diversion control strategies with the needs of patients. 

• Dosing and Take-homes: In the area of dosing and take-homes, diversion control 

encompasses careful control of inventory, attentive patient dosing, and close supervision of 

take-homes. Although observing a patient take his or her dose and having each of them drink 

and speak after dosing are fundamental components of diversion control, it is easy to lose 

sight of the importance of these repetitive nursing tasks. 

Take-home dosing should be provided with careful attention to regulatory compliance and

the therapeutic benefit and safety these regulations are meant to promote. Random call backs 

to inventory a patient’s take-home doses are an important element of any DCP. Patients must 

be clearly informed of the responsibility they have to keep take-home opioid medications in a 

child-proof medication container and store them in a secure location. It also is important to 

perform toxicology testing on patients with take-home doses without falling into a 

predictable routine and to have clear policies and procedures to prevent the falsification of 

toxicology specimens. A program’s response to toxicology specimens that are negative for 

methadone or otherwise indicative of falsification needs to address the possibility of 

diversion of methadone. Simple strategies, such as requiring the return of all take-home dose 

bottles, can reduce the opportunity for passing off diverted methadone as legitimate. Always 
FEDERAL OPIOID TREATMENT STANDARDS 19

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

investigate the alleged or actual source of diversion, and, if necessary, change the frequency 

of take-home reviews. 

Drug testing regimens also may have to be reevaluated. Special, intensified group or 

individual counseling sessions may be helpful for individuals or groups at risk for diversion 

problems. Programs currently closing for Sundays or holidays should have clearly spelled 

out policies and procedures for determining who may have a take-home dose for these days. 

Universally granting take-homes for days when the program is closed increases the 

program’s risk for diversion and adverse outcomes. Consideration should be given to 

opening on these days for a short period to administer medications to those patients not yet 

able to dose safely without supervision. 

Monitoring patients receiving medication for unsupervised use requires the physician to have 

knowledge of physiological issues; a thorough understanding of the differences among 

laboratories; and the factors that affect absorption, metabolism, and elimination of opioids. 

Knowledge and understanding in these areas are essential, for example, to interpret a 

toxicology test that is negative for methadone or methadone metabolites. All staff members 

may contribute to the safety and therapeutic benefits of unsupervised medication use. Any 

observations or information relevant to the use of unsupervised medication use acquired in 

the course of interacting with patients is to be conveyed to the medical director for his or her 

consideration in making dosing and management decisions. 

• Prevention of Multiple Program Enrollment: Reasonable measures should be taken to 

prevent patients from enrolling in treatment provided by more than one clinic or individual 

practitioner. These measures should be commensurate with the severity of the problem and 

the documented consequences. An OTP, after obtaining patient consent, may contact other 

OTPs within a reasonable geographic distance (100 miles) to verify that a patient is not 

enrolled in another OTP. Refer to CFR 42 § 2.1 Statutory authority for confidentiality of 

drug abuse patient records (http://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=601aa488f5b738f0e5b9befaf27d2637&n=42y1.0.1.1.2&r=PA

RT&ty=HTML%20-%2042:1.0.1.1.2.1.1.1) for further clarification.

• Misuse of Prescription Medication: The misuse of prescription medication has become an 

area of great concern nationally and impacts diversion control planning at OTPs. Nearly all 

states have a prescription drug monitoring program (PDMP) of some sort. Up-to-date 

information about each state’s PDMP can be found at Brandeis University’s PDMP Training 

and Technical Assistance Center. In addition, the National Alliance of Model State Drug 

Laws is another source of information. 

While state programs may vary from one another, all OTP physicians and other healthcare 

providers, as permitted, should register to use their respective state’s PDMP and query it for 

each newly admitted patient prior to initiating dosing. The PDMP should be checked 

periodically (for example, quarterly) through the course of each individual’s treatment and, in 

particular, before ordering take-home doses as well as at other important clinical decision 

points. Querying the PDMP will result in a range of possible results. In some cases, no use 
FEDERAL OPIOID TREATMENT STANDARDS 20

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

of scheduled prescription medications will be identified. In others, the history of prescription 

use reported by the patient will be confirmed. If the patient has ongoing relationships with 

prescribers from whom they may still acquire prescriptions for controlled substances or other 

psychotropics, strategies to prevent or limit this activity should be established. Ideally, 

releases of information should be obtained from each prescriber in order to coordinate 

needed medical care while avoiding the use of medications that may interact with the 

pharmacotherapy for a substance use disorder. Lastly, the PDMP may reveal ongoing receipt 

of prescriptions not reported to the program for substances known to be misused by the 

patient. An assertive strategy of care coordination combined with additional treatment 

strategies, such as medically supervised withdrawal from the misused prescription 

medications and intensive behavioral interventions, may need to be implemented. In some 

situations, the presence of active diversion may lead to discharge for reasons of patient safety 

or the safety of the community. Of particular concern is when a patient refuses to sign a 

release of information to allow care coordination with other prescribers. 

The program should develop detailed policies and procedures to govern the use of and 

response to PDMP information for diversion control. Every effort, including full psychiatric 

assessment, higher levels of substance use disorder treatment, detoxification services, and 

intensive counseling, should be made to address the addictive behaviors underlying the 

individual’s polysubstance use. 

The responsibility to implement and monitor each aspect of the DCP should be clearly 

assigned to specific clinical, administrative, or medical staff members as appropriate. These 

staff members should have the opportunity to meet regularly to update one another on issues 

and communicate concerns. This may be accomplished during regular meetings of a specific 

diversion control committee. In smaller programs, the DCP may be a regular business item 

during meetings of all staff. Specific procedures for monitoring possible diversion in each of 

these areas and how to address it should be spelled out. 

PROFESSIONAL STAFF CREDENTIALS AND DEVELOPMENT

42 CFR 8.12(d) Staff credentials. Each person engaged in the treatment of opioid 

addiction must have sufficient education, training, and experience, or any combination 

thereof, to enable that person to perform the assigned functions. All physicians, nurses, 

and other licensed professional care providers, including addiction counselors, must 

comply with the credentialing requirements of their respective professions.

Each staff position in an OTP should have a specific and detailed position description that 

outlines the duties assigned to the position, the qualifications required to enter into the position, 

and the training and performance standards required to remain in the position. Before providing 

care to patients, staff members should receive initial education that is specific to the medicationassisted treatment(s) used in the OTP and tailored to the patient populations served. In addition, 

continuing education in opioid addiction treatment and related subjects, along with resources for 
FEDERAL OPIOID TREATMENT STANDARDS 21

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

problem solving and troubleshooting, should be accessible. The position descriptions and 

assigned duties for both licensed clinical and medical professionals should respect the scope of 

practice assigned to each licensed profession by the respective staff licensing authority. All 

licensed individuals employed in OTPs must comply at all times with the licensing and 

credentialing requirements of their respective professions. Physicians should have completed an 

accredited residency training program and have at least 1 year of experience in addiction 

medicine or psychiatry. Board certification in their primary medical specialty and in addiction 

psychiatry or addiction medicine is preferred. All OTP physicians are urged to complete training

on the use of all FDA approved medications for the treatment of opioid use disorders. Other 

healthcare professionals employed in OTPs should be similarly qualified. 

Detailed job descriptions that clearly define the qualifications and competencies needed to 

provide specific services should be developed for credentialed and non-credentialed staff. Nonlicensed staff may be qualified for their positions through training, education, and/or experience. 

In states that permit non-licensed addictions counselors, programs should develop the position 

description in accordance with standards put forward by a formal body such as those published 

by the National Certification Commission for Addiction Professionals. 

A personnel file should be maintained for each staff person. The file should contain an 

individualized annual training plan; documentation of training, which includes a record of 

attendance; the qualifications of the educators; outlines of the content; description of the teaching 

methods employed; and performance evaluations as well as employment application data, date of 

employment, updated licensing and credentialing information, detailed job descriptions, and 

other employment and credentialing data deemed appropriate. 

PATIENT ADMISSION CRITERIA

42 CFR 8.12(e) Patient admission criteria. (1) Maintenance treatment. An OTP shall 

maintain current procedures designed to ensure that patients are admitted to 

maintenance treatment by qualified personnel who have determined, using accepted 

medical criteria such as those listed in the Diagnostic and Statistical Manual for Mental 

Disorders (DSM-IV), that the person is currently addicted to an opioid drug, and that the 

person became addicted at least 1 year before admission for treatment. In addition, a 

program physician shall ensure that each patient voluntarily chooses maintenance 

treatment and that all relevant facts concerning the use of the opioid drug are clearly and 

adequately explained to the patient, and that each patient provides informed written 

consent to treatment.
FEDERAL OPIOID TREATMENT STANDARDS 22

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

(2) Maintenance treatment for persons under age 18. A person under 18 years of age is 

required to have had two documented unsuccessful attempts at short-term medical 

withdrawal (detoxification) or drug-free treatment within a 12-month period to be eligible 

for methadone maintenance treatment. No person under 18 years of age may be 

admitted to maintenance treatment unless a parent, legal guardian, or responsible adult 

designated by the relevant State authority consents in writing to such treatment. 

(3) Maintenance treatment admission exceptions. If clinically appropriate, the program 

physician may waive the requirement of a 1-year history of addiction under paragraph 

(e)(1) of this section, for patients released from penal institutions with a documented 

history of opioid use disorder (within 6 months after release), for pregnant patients 

(program physician must certify pregnancy), and for previously treated patients (up to 2 

years after discharge).

(4) Detoxification (medical withdrawal) treatment. An OTP shall maintain current 

procedures that are designed to ensure that patients are admitted to short- or long-term 

detoxification treatment by qualified personnel, such as a program physician, who 

determines that such treatment is appropriate for the specific patient by applying 

established diagnostic criteria. Patients with two or more unsuccessful detoxification 

episodes within a 12-month period must be assessed by the OTP physician for other forms 

of treatment. A program shall not admit a patient for more than two detoxification 

treatment episodes in one year.

Admission to an OTP for maintenance or medical withdrawal with pharmacotherapy requires 

fulfillment of specific criteria. The OTP should have up-to-date policies and procedures in place 

to assure that all admission criteria are met or exceptions obtained, as appropriate. These 

policies and procedures should include a requirement for programs to demonstrate how the 

treatment needs of those persons for whom admission is not appropriate will be met, regardless 

of whether they are through other services offered by the program or a formal referral. All 

persons to be admitted for maintenance therapy must be determined to be “currently addicted to 

an opioid drug.” 

The regulations specify that accepted medical criteria such as those described in the most current 

version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) be used. New 

criteria in DSM-V, the current version, use language that is consistent with the current 

understanding of substance use disorders, departing somewhat from the familiar terms of 

“abuse” and “dependence.” The diagnostic criteria described in the DSM-V, however, are 

substantially the same as those used in earlier versions of the DSM. Based on the number of 

criteria identified for an individual patient, the substance use disorder is now classified as mild, 

moderate, or severe. Because there is no basis for concluding that medication-assisted treatment 

is only for those persons with severe disease, careful consideration and patient-center decision 

making must be used when considering the most appropriate pharmacotherapy for patients at all 

stages of opioid use disorder. For more information, refer to Decision in Recovery: Medication 
FEDERAL OPIOID TREATMENT STANDARDS 23

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

for Opioid Addiction, a multimedia interactive decision support tool available soon on 

samhsa.gov. If a patient has a mild or moderate opioid use disorder without meeting criteria for 

tolerance/withdrawal, opioid agonist medications that will themselves produce physical 

dependence must be carefully considered due to the difficulty experienced by many of the 

discontinuation of opioids on which an individual has become physically dependent. Other 

options such as psychotherapy or antagonist pharmacotherapy such as oral/injectable naltrexone 

treatment should be considered. The new criteria require a more comprehensive approach to 

patient assessment and more sophisticated treatment matching. More information can be found 

on http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf. Additionally, the 

SAMHSA advisory on the use of extendable release of injectable naltrexone for the treatment of 

people with opioid dependence can be accessed at http://store.samhsa.gov/product/AnIntroduction-to-Extended-Release-Injectable-Naltrexone-for-the-Treatment-of-People-withOpioid-Dependence/SMA12-4682. 

The scope of the problem of opioid misuse and consequent overdoses requires a more highly 

individualized approach to treatment decision making and access to the full range of 

pharmacotherapies including antagonists. OTPs should endeavor to provide a full range of 

pharmaceuticals for medication-assisted therapy in order to best meet the needs of the patient. A 

decision to admit a patient for opioid agonist or antagonist maintenance treatment should be 

based on an assessment by appropriately “qualified personnel.” (42 CFR § 8.12(e)). Since the 

admission criteria require a diagnostic and treatment decision, the OTP staff person who 

performs this function should be permitted by license and credential to conduct interviews and 

physical examinations, review records of other providers, and diagnose and treat patients. 

Reference should be made to state licensing authorities to determine whether advanced practice 

nurses, physician assistants, or others can be permitted to determine whether admission criteria 

are fulfilled. The DEA maintains a table of prescribing authority by state for health professionals 

that can be found at http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf. 

While “qualified personnel” may perform admission assessments for maintenance treatment, 

only physicians may perform the following functions under 42 CFR § 8.12(e). 

• “a program physician shall ensure that each patient voluntarily chooses maintenance 

treatment and that all relevant facts concerning the use of the opioid drug are clearly and 

adequately explained to the patient, and that each patient provides informed written consent 

to treatment.” (42 CFR § 8.12(e)(1)). 

• “the program physician may waive the requirement of a 1-year history of addiction under 

paragraph (e)(1).” (42 CFR § 8.12(e)(3)).” 

• “for pregnant patients (program physician must certify pregnancy)” (42 CFR § 8.12(e)(3). 

Informed Consent

An acceptable informed consent policy should: 

• Inform each patient about all treatment procedures, services, and other policies and 

regulations throughout the course of treatment. It should also ensure that each patient 
FEDERAL OPIOID TREATMENT STANDARDS 24

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

voluntarily chooses maintenance treatment and that all relevant facts concerning the use of 

the opioid drug are clearly and adequately explained to the patient.

• Ensure that before medicating the patient the physician receives voluntary, written, programspecific informed consent to treatment with the specific pharmacotherapy ordered by the 

physician. Within 30 days post-admission, an appropriate program staff member should 

review informed consent with the patient. 

• Inform each patient at admission and upon a 30-day review that the goal of medicationassisted treatment is stabilization of functioning.

• Inform each patient at admission of state-specific requirements and program policies 

regarding the report of suspected child abuse and neglect, as well as other forms of abuse 

(e.g., violence against women). 

• Include a written description of patients’ rights and responsibilities that is reviewed with the 

patient. An example can be found at

http://www.nlm.nih.gov/medlineplus/ency/article/001947.htm

MEDICALLY SUPERVISED WITHDRAWAL

42 CFR 8.12(e) (4). Detoxification treatment. An OTP shall maintain current procedures 

that are designed to ensure that patients are admitted to short- or long-term 

detoxification treatment by qualified personnel, such as a program physician, who 

determines that such treatment is appropriate for the specific patient by applying 

established diagnostic criteria. Patients with two or more unsuccessful detoxification 

episodes within a 12-month period must be assessed by the OTP physician for other forms 

of treatment. A program shall not admit a patient for more than two detoxification 

treatment episodes in 1 year.

Overdose prevention, including prescribing or dispensing naloxone, is an essential complement 

to both detoxification services as well as medically supervised withdrawal discussed in the 

following sections. For detailed guidance please refer to SAMHSA’s Opioid Overdose 

Prevention Tool Kit found at http://store.samhsa.gov/product/Opioid-Overdose-PreventionToolkit/SMA13-4742. Similarly, patients should be advised of the risks of relapse following 

detoxification and offered a relapse prevention program that includes counseling, naloxone and 

opioid antagonist therapy.

Detoxification

Detoxification is a legal and regulatory term that has fallen into disfavor with the medical 

community and is generally viewed as a misnomer. For the purposes of compliance, refer to the 

definitions for “detoxification treatment, long-term detoxification and short-term detoxification” 

in 42 CFR § 8.2. Detoxification is specifically intended to describe a service provided to patients 
FEDERAL OPIOID TREATMENT STANDARDS 25

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

to address dependence on their opioid drug of choice. A discussion of medically supervised 

withdrawal, which is the more accurate description of the gradual reduction or tapering of the 

medication dosage over time under the supervision of the physician, is included in this section. 

Medically supervised withdrawal may be either voluntary or involuntary. Its purpose is to 

eliminate physical dependence on opioid medications. Although medically supervised 

withdrawal is not specifically addressed in the regulations, these guidelines address the 

community standards for approaching this stage of treatment. 

Detoxification can be considered the medically supported transition to a medication-free state or 

to antagonist therapy. Many OTPs do not provide a specific pathway for patients to go directly 

to a medication-free state because of the notoriously poor outcomes and high incidence of 

relapse to drug use. Please refer to TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). With the decreased availability

and insurance reimbursement for inpatient detoxification services and the advent of long-acting 

antagonist therapy, each program should evaluate the need to develop policies and procedures to 

provide this service so that treatment can be matched to the individual needs and preferences of 

the patient. Very careful review of the risks and benefits of detoxification must be provided and 

thorough informed consent obtained from patients choosing this treatment option. Because of 

the risk of fatal overdose if relapse occurs, detoxification services should be accompanied by 

relapse prevention counseling, overdose prevention education as well as a naloxone kit 

(naloxone dose and syringes) or an FDA-approved naloxone auto injector. The treatment and 

aftercare plans should always include a strategy to transition to medication-assisted treatment if 

needed.

Voluntary Medically Supervised Withdrawal 

Voluntary medically supervised withdrawal is completely different from involuntary tapering, 

administrative withdrawal, or other types of medically supervised withdrawal. The physician 

initiates voluntary medically supervised withdrawal from medication-assisted treatment in 

collaboration with and at the request of the rehabilitated patient. In initiating voluntary 

medically supervised withdrawal, the physician reduces dosages of medication at a rate well 

tolerated by the patient and in accordance with sound clinical judgment and close observation of 

the patient. Please refer to TIP 43 for guidance 

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf).

For women with childbearing potential, the physician conducts an assessment for pregnancy and 

reviews the results of a pregnancy test before initiating medically supervised withdrawal. For 

pregnant patients, the physician should not initiate withdrawal before 14 weeks or after 32 weeks 

of gestation. When the patient experiences intolerable withdrawal symptoms or actual or 

potential relapse, the physician should consider halting the withdrawal process and possibly 

restoring the patient to a previously effective dose. Patient and physician together may decide 

that an additional period of maintenance is necessary before further medically supervised 

withdrawal is attempted. 

Regardless of whether medically supervised withdrawal is conducted with or against medical 

advice, very careful review of the risks and benefits of withdrawal from maintenance therapy 
FEDERAL OPIOID TREATMENT STANDARDS 26

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

must be provided and thorough informed consent obtained from patients choosing medically 

supervised withdrawal. Because of the risk of fatal overdose if relapse occurs, medically 

supervised withdrawal services should be accompanied by relapse prevention counseling, 

overdose prevention education and naloxone prescription. The treatment and aftercare plans 

should always include a strategy to transition to medication-assisted treatment with antagonist or 

agonist therapy if needed. OTPs should offer a variety of supportive options as part of the 

transition from opioid agonist therapy. For example increased counseling should be available 

prior to discharge, and participants encouraged to attend a 12-step or other mutual-help program 

sensitive to the needs of patients receiving medication-assisted treatment.

Withdrawal against Medical Advice

A patient who requests voluntary medically supervised withdrawal from medication-assisted 

treatment against the medical advice (AMA) of the physician or program staff may receive it. A 

patient has the right to leave treatment when he/she chooses to do so. The program will offer all 

the same services to the patient voluntarily withdrawing from medication-assisted treatment 

regardless of whether the decision is AMA. 

An OTP may readmit a patient who abruptly left the program within 30 days of his/her departure 

without repeating the initial assessment procedure required by 42 CFR § 8.12(f)(4). The 

program must fully document both the issue that caused the patient to seek discharge and the 

steps it took to avoid discharging the patient as well as the circumstances of the readmission. In 

the case of a pregnant patient, the program must keep the physician or agency providing prenatal 

care for the patient informed, consistent with the privacy standards of 42 CFR § 2. 

Involuntary Withdrawal from Treatment

A major goal of an OTP is to retain patients for as long as they can benefit from and express a 

desire to continue treatment. Programs should make every effort to intervene productively in a 

patient’s situation before resorting to administrative withdrawal. For example, patients with 

disruptive behavior should be screened and, if needed, referred for a full psychiatric evaluation. 

The type and quantity of behavioral services as well as the medical supervision for patients at 

risk for administrative withdrawal should be matched to address the degree of risk behavior. 

Involuntary "administrative withdrawal" requires OTPs to define and follow due process. The 

underlying goal is for involuntary medically supervised withdrawal to reflect a humane 

partnership between the patient and the treatment program. The program policies and procedures 

must take into consideration, on a case-by-case basis, all factors affecting the patient and all the 

steps involved in the process must be documented. Because of the risk of fatal overdose if 

relapse occurs, medically supervised withdrawal services should be accompanied by relapse 

prevention counseling, overdose prevention education as well as a naloxone prescription. The 

treatment and aftercare plans should always include a strategy to transition to medicationassisted treatment including antagonist pharmacotherapy if needed.

42 CFR § 8.12 does not specify under what conditions administrative withdrawal is considered 

appropriate. Standard practice regarding involuntary discharge among OTPs provide for the 

following situations:
FEDERAL OPIOID TREATMENT STANDARDS 27

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• Nonpayment of fees. Remedies may include referral to a more affordable OTP or other 

forms of medication-assisted treatment.

• Disruptive conduct or behavior. Disruptive behaviors include dealing drugs, repeated 

loitering, or violation of treatment program rules resulting in documented observable, 

negative effect on the individual, program, staff, and/or other patients not successfully 

addressed by more conservative means. Clinical interventions should be aimed at retaining 

these patients in treatment and may include, as appropriate, intensified counseling 

opportunities, special treatment plans addressing the behavior, and/or referrals for mental 

health evaluation. 

• Violent conduct or threatening behaviors. Violent conduct or threatening behaviors include 

assaults or attempted assaults and direct and credible threats of violence towards other 

patients, program staff members, or visitors. If practical under the circumstances and with 

due regard for patient and OTP staff safety, before administrative discharge, it is 

recommended that the OTP conduct a crisis assessment to address suicide risk, danger to self 

or others, urgent or critical medical conditions, and immediate threats. Please refer to 

SAMHSA’s Suicide Prevention App for Behavioral Health and Primary Care Providers

(http://store.samhsa.gov/apps/suicidesafe/) 

• Incarceration or other confinement that does not permit medically supervised withdrawal for 

patients receiving maintenance therapy with an opioid agonist. 

Administrative discharge of a pregnant patient is a medically high-risk undertaking. As with all 

patients, interventions to address problematic behavior should be intensive and begin at the 

earliest suggestion of concern. Transfer to treatment in another program is preferable to 

medically supervised withdrawal in pregnancy. It may be helpful for the program to establish 

transfer agreements for treatment for this purpose in advance of the need. In the rare event a 

pregnant patient is administratively withdrawn and discharged, the program must ensure referrals 

are followed through to completion. Provider(s) should carefully follow up the patient’s 

pregnancy and opioid use disorder. 

When a patient is administratively discharged from an OTP, the program must employ the same 

principles as those used for voluntary medically supervised withdrawal from medication. The 

goal is to follow a withdrawal schedule that is based on sound clinical judgment and close patient 

monitoring. A schedule for medically supervised withdrawal for administrative withdrawal from 

treatment is generally a minimum of 21 days, but the physician may adjust this timeframe 

depending on clinical factors. The patient’s condition during this medically supervised 

withdrawal and all steps to address it should be documented in the patient’s record. 

Access TIP 43 (http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf) for additional 

information. 

Administrative withdrawal is usually involuntary and used only when all therapeutic options 

have been exhausted. Given the short timeframe in which administrative withdrawal occurs and 

the poor prognosis of patients who are involuntarily discharged, the preferred approach is for 
FEDERAL OPIOID TREATMENT STANDARDS 28

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

OTPs to refer or transfer patients to a suitable alterative treatment program. Because of the risks 

of relapse following detoxification, patients should be offered a relapse prevention program that 

includes counseling, naloxone and opioid antagonist therapy.

REQUIRED SERVICES

42 CFR 8.12(f) Required services. (1) General. OTPs shall provide adequate medical, 

counseling, vocational, educational, and other assessment and treatment services. These 

services must be available at the primary facility, except where the program sponsor has 

entered into a formal, 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.

OTPs must provide adequate medical, counseling, vocational, educational, and other assessment 

and treatment services. Any assessments or treatments not directly provided at the facility must 

be assured via a formal documented agreement with the appropriate community providers. 

Adequacy of services is manifest by a plan to manage and follow up each problem identified in 

the patient’s history, physical exam, psychiatric evaluation, health risk assessments, and social 

support evaluations within 30 days of admission. An OTP should have appropriate informationsharing agreements with other providers, in accordance with federal regulations, in order for 

these services to be considered fully available to patients.

Assessment begins during program admission and continues throughout treatment. Its purpose is 

to address the whole health and well-being of the patient. Assessment begins with a personal 

substance use history, physical examination, laboratory evaluation, and determination of disease 

morbidity. Subsequently, professional staff will further assess the severity of disease in terms of 

patient response to pharmacotherapy, recovery resources, coping skills, and psychosocial 

morbidity. Assessment also may involve determining patient motivation and readiness for 

change as indicated on page 284 in TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). Additional resources are 

available at http://www.samhsa.gov/sbirt. The SAMHSA SBIRT page has links to motivational 

interviewing and readiness for change. 

Consulting the PDMP at admission and periodically (for example, every three months) thereafter 

should be one of the tools used in the ongoing assessment of the patient. The program should 

update each patient’s assessment at least quarterly during the first year of continuous treatment 

and semi-annually in subsequent years unless another schedule is stipulated by state or local 

regulations. 
FEDERAL OPIOID TREATMENT STANDARDS 29

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

INITIAL MEDICAL EXAMINATION SERVICES

42 CFR 8.12(f) Required services. (2) Initial medical examination services. OTPs shall 

require each patient to undergo a complete, fully documented physical evaluation by a 

program physician or a primary care physician, or an authorized healthcare professional 

under the supervision of a program physician, before admission to the OTP. The full 

medical examination, including the results of serology and other tests, must be completed 

within 14 days following admission.

All individuals who meet OTP admission criteria must receive a complete, fully documented 

physical evaluation prior to admission to the OTP. The initial medical examination should 

provide the basis upon which the admission criteria are satisfied and the justification for the 

pharmacotherapy selected. The patient re-entering treatment may need a repeat examination 

depending on the time elapsed since the original examination. The Evaluation and Management 

(E&M) definitions for an expanded problem-focused or detailed medical examination provide 

useful models of what would be considered adequate, in most cases, for fulfilling the regulatory 

requirements, but should not limit the examination of patients who, in the judgment of the 

physician, merit more comprehensive evaluation. E&M definitions can be found at 

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-NetworkMLN/MLNProducts/Downloads/eval_mgmt_serv_guide-ICN006764.pdf. 

The purpose of the initial medical evaluation is to confirm the diagnosis of opioid use disorder 

and identify co-occurring medical and psychiatric conditions that may make medication-assisted 

treatment unsafe, limit its effectiveness, influence the selection of pharmacotherapy, or require 

prompt medical attention. Screening should be conducted for common co-occurring conditions 

even if the patient has no personal history of them. Screening should establish the risk of 

undiagnosed conditions such as Hepatitis C, the human immunodeficiency virus (HIV), sexually 

transmitted infections (STIs), cardio-pulmonary disease, and sleep apnea in order to determine 

what further diagnostic testing such as laboratory studies, a cardiogram, and others are needed. 

Opportunities for disease prevention should also be identified at this time; for example, the need 

for gynecologic care or vaccinations for Hepatitis A and B, Tetanus, Pneumococcal Disease, or 

Influenza. Positive screening results or disease risks must have a management plan that is seen 

through to completion regardless of whether this is accomplished via services provided directly 

on-site or by referral and care coordination. 

Initial toxicology tests are a part of the admission process. At a minimum, admission samples 

are tested for opioids, methadone, buprenorphine, amphetamines, cocaine, marijuana, and 

benzodiazepines. If there is a history of prescription opioid analgesic abuse, an expanded 

toxicology panel that includes these opioids should be administered. Additional testing is based 

on individual patient need and local drug use patterns and trends. Furthermore, there are a 

variety of recommendations on the use of electrocardiograms (EKG) in patients receiving 

methadone. The most prominent guidance addresses cardiac risks with regard to the use of 

methadone for pain management. 
FEDERAL OPIOID TREATMENT STANDARDS 30

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

SAMHSA has published the report of an expert panel on QT interval screening in methadone 

maintenance. The panel recommended that programs develop clear policies and procedures 

describing a universal Cardiac Risk Management Plan that incorporates clinical assessment, 

electrocardiogram assessment, risk stratification, and prevention of drug interactions for all 

patients. Patient-specific risk minimization strategies such as careful patient monitoring; 

obtaining electrocardiograms as indicated by a particular patient's risk profile; and adjusting the 

methadone dose, as needed, for patients with identified risk factors for adverse cardiac events 

should also be included. The panel also suggested specific modifications to informed consent 

documents, patient education, staff education, and methadone protocols. 

A patient’s physical examination should document the presence of clinical signs of addiction, 

such as old and fresh needle marks and an eroded or perforated nasal septum and/or a state or 

symptoms of intoxication, such as constricted or (pinpoint) pupils, slowed heart or respiratory 

rate, or drowsiness or withdrawal, such as yawning, rhinorrhea, lacrimation, chills, restlessness, 

irritability, perspiration, piloerection, nausea, and diarrhea. There should be a high degree of 

concordance between the documented physical examination findings and the symptoms reported 

in the review of systems.

The assessment and plan resulting from this initial medical evaluation should summarize positive 

screening findings for which further evaluation is required and how this will be accomplished; 

deficiencies in health maintenance and how preventive services should be introduced, a list of all 

identified co-occurring problems and the plan to address them even if by referral; substance use 

diagnoses for each substance used along with severity; the medication selected and rationale for 

prescribing it and the expected impact of pharmacotherapy; and the education provided to the 

patient about his or her health conditions and any potential interactions or complications that 

may occur in regards to the planned medication-assisted treatment. 

The results of laboratory work as well as the following services: psychosocial assessment; 

preliminary treatment plan; and patient orientation should be completed within 14 days of 

admission. Releases of information should be obtained at this time from other treating 

physicians or prescribers identified on the state PDMP. Also during this time, proper patient 

consent should be obtained by the program to seek medical records from other healthcare 

providers. 

PREGNANT AND POSTPARTUM PATIENTS

42 CFR § 8.12(f) (3). Special services for pregnant patients. OTPs must maintain current 

policies and procedures that reflect the special needs of patients who are pregnant. 

Prenatal care and other gender specific services or pregnant patients must be provided 

either by the OTP or by referral to appropriate healthcare providers.

As of this writing, both methadone and buprenorphine are Pregnancy Category C drugs that call 

for a careful risk/benefit analysis, but for which there is no known teratogenic effects to the 
FEDERAL OPIOID TREATMENT STANDARDS 31

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

human fetus when medication is taken as directed and relapse is avoided. Both medications 

produce opioid dependence in the newborn which requires assessment and monitoring and may 

require specific medical care. Although the level of evidence supporting buprenorphine 

maintenance during pregnancy is not as voluminous as that supporting methadone maintenance 

treatment, decisions need to factor in access and the specific needs and goals of the patient. 

Pregnant women seeking treatment from an OTP must be given priority both for interim 

maintenance therapy and in the context of transfers from interim maintenance to comprehensive 

maintenance therapy. Reasons for denying admission to a pregnant applicant should be 

documented in the OTP’s intake log or other enduring program records. 

Every pregnant patient in an OTP should receive prenatal care, provided either onsite or by other 

healthcare providers. If appropriate prenatal care is neither available onsite nor by referral, or if 

the pregnant patient cannot afford care or refuses prenatal care services, an OTP, at a minimum, 

should offer basic prenatal instruction on maternal, physical, and dietary care as part of its 

counseling services. In cases where the OTP refers the patient elsewhere for prenatal care, the 

program should have formal documented agreements and informed consent procedures in place 

that ensure reciprocity in the exchange of pertinent clinical information regarding compliance 

with the recommended course of medical care. If a pregnant patient refuses the offered onsite or 

referred prenatal services, the treating physician or authorized healthcare professional, as 

appropriate, may use informed consent procedures to have the patient formally acknowledge, in 

writing, her refusal of these services. Policies forbidding children in the facility are not 

appropriate. Every attempt should be made to provide a safe and supportive environment for 

parents and their small children. 

For pregnant women receiving methadone or buprenorphine, the OTP should have policies and 

procedures in place to assure the:

• Initial dose for a newly admitted pregnant patient and the subsequent induction and 

maintenance dosing strategy reflect the same effective dosing protocols used for all other 

patients.

• Methadone dose is carefully monitored, especially during the third trimester when pregnancy 

induces changes, such as the rate at which methadone is metabolized or eliminated from the 

system, potentially necessitating either an increased or a split dose.

• Patients who become pregnant during treatment are maintained at their pre-pregnancy 

dosage, if effective, and are managed with the same dosing principles used with nonpregnant patients. 

Pregnant women are encouraged to consider ongoing maintenance treatment after delivery. 

Medically supervised withdrawal after pregnancy should occur only when clinically indicated or 

requested by the patient. If a pregnant patient is discharged, the OTP must identifies the specific 

physician or authorized healthcare professional, as appropriate, to whom the patient is being 
FEDERAL OPIOID TREATMENT STANDARDS 32

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

discharged. The name, address, and telephone number of the provider caring for the patient after 

discharge are to be recorded in the patient record. 

The OTP should establish and implement policies and procedures, including informed consent, 

to ensure appropriate follow-up and primary care for the new mother and well-baby care for the 

infant. Informed consent refers to the patient’s agreement to receive treatment as well as to 

release information to and obtain information from pertinent healthcare providers. Appropriate 

counseling and informed decision making between provider and patient must take place and be 

documented to ensure that issues mentioned in the latest patient information sheets and product 

inserts for the prescribed medication are covered and understood. 

Pregnant women with concurrent HIV infection are subject to the same policies and procedures 

established for all HIV-infected patients in medication-assisted treatment and receive the same 

treatment opportunities and services, directly or by referral, as HIV-diagnosed patients who are 

not pregnant. OTPs ensure that all pregnant patients with concurrent HIV infection are (1) 

informed that HIV medication treatment is currently recommended to reduce perinatal 

transmission and (2) provided with appropriate referrals and case management for this treatment. 

OTPs should have policies and procedures in place to support the decision to breastfeed during 

medication-assisted treatment, unless medically contraindicated by, for example, the presence of 

HIV, HTLV I or II, or untreated tuberculosis infection in the mother or if the mother is taking 

certain cancer chemotherapy agents, such as antimetabolites that interfere with DNA replication 

and cell division. 

NEONATAL ABSTINENCE SYNDROME

Neonatal abstinence syndrome is a group of problems that occur in a newborn who was exposed 

to medications or drugs in utero. Babies of mothers who drink alcohol during pregnancy may 

have a similar condition. Infants prenatally exposed to opioids may experience hyperactivity of 

the central and autonomic nervous systems. This causes symptoms affecting the gastrointestinal 

tract and respiratory system. Signs of withdrawal from opioids may begin at any time, from 

minutes to hours to 2 weeks after birth; however, most appear within 72 hours. Neonatal 

abstinence syndrome will require management with a regimen of opioid agonist medication in 

tapering doses for approximately half of opioid-exposed infants. This often requires extended

inpatient hospitalization and supportive care. 

Programs should make certain the newborns of OTP patients receive prompt medical evaluation 

if signs or symptoms of neonatal abstinence syndrome appear after discharge from the hospital. 

(Access: http://vec.chop.edu/healthinfo/neonatal-abstinence-syndrome.html.) This means that 

mothers must be educated about neonatal abstinence syndrome, its symptoms, its potential effect 

on their infants, and need for treatment should it occur. 
FEDERAL OPIOID TREATMENT STANDARDS 33

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

CLINICAL ASSESSMENT, TREATMENT PLANNING, AND EVALUATION OF PATIENT PROGRESS IN 

TREATMENT

42 CFR § 8.12 (f) (4). Initial and periodic assessment services. Each patient accepted for 

treatment at an OTP shall be assessed initially and periodically by qualified personnel to 

determine the most appropriate combination of services and treatment. The initial 

assessment must include preparation of a treatment plan that includes the patient’s shortterm goals and the tasks the patient must perform to complete the short-term goals; the 

patient’s requirements for education, vocational rehabilitation, and employment; and the 

medical, psycho- social, economic, legal, or other supportive services that a patient needs. 

The treatment plan also must identify the frequency with which these services are to be 

provided. The plan must be reviewed and updated to reflect that patient’s personal 

history, his or her current needs for medical, social, and psychological services, and his or 

her current needs for education, vocational rehabilitation, and employment services.

Assessment and Treatment Planning

The purpose of an assessment is to determine treatment eligibility, develop a treatment plan, and 

establish a measure for the response to treatment. “Assessment” is the process of identifying the 

precise nature and extent of a patient’s substance use disorder and other medical, mental health, 

and social problems as a basis for treatment planning. Assessment usually begins during 

program admission and continues throughout treatment. It includes completing a personal 

substance abuse history, physical examination, laboratory evaluation, and determination of 

disease morbidity. Often, professional staff may further assess the severity of disease in terms of 

physiologic dependence, organ system damage, and psychosocial morbidity. Assessment also 

may involve determining patient motivation and readiness for change. 

The clinical assessment of each patient takes into account the natural history of opioid addiction 

as altered by time and treatment as well as the individual’s past experience with treatment and 

recovery. In addition, all patients entering OTPs must be screened for other problem substance 

use and for mental health issues such as depression and anxiety. Positive screening results or 

disease risks must have a management plan that is seen through to completion regardless of 

whether this is accomplished via services provided directly on-site or by referral and care 

coordination. SAMHSA has supported a program of Screening, Brief Intervention, and Referral 

to Treatment (SBIRT) that can assist with screening for co-occurring behavioral health disorders. 

(Access: http://www.samhsa.gov/sbirt.) 

A complete inventory of the individual’s strengths and weakness as well as recovery resources is 

necessary to individualize the assessment. Based on the assessment and building upon the stage 

of treatment, an individualized treatment plan can then be designed. Assessment will need to 

occur repeatedly throughout the treatment experience as the stage of treatment as well as the 

unique variables of the individual patient will change over time. For information on the stages of 

treatment, please visit: http://www.ncbi.nlm.nih.gov/books/NBK64208/. 
FEDERAL OPIOID TREATMENT STANDARDS 34

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

The patient and therapist identify and agree upon a specific set of goals and develop a treatment 

plan to achieve them. The goals should be specific, measurable, realistically attainable, and 

patient centered. For more information, refer to Decision in Recovery: Medication for Opioid 

Addiction, a multimedia interactive decision support tool available soon on samhsa.gov. 

Evaluation 

Evaluation is the close examination or appraisal of a patient’s health, including the patient’s 

physical and mental capacity and potential. A patient who is being admitted to treatment should 

receive an intensive evaluation that includes a health history, medical exam, and screening. 

Evaluation results enable program staff to determine the patient’s current degree of dependence 

on narcotics and, to the extent possible, the length of time the patient has been dependent on 

opioids. Program staff must use this information to determine the appropriate pharmacoptherapy 

and the initial dosage of medication and place the patient into the appropriate level of treatment. 

A full medical exam should be completed within 14 days of treatment initiation.

Evaluation of the effectiveness of the patient-centered treatment plan needs to be performed at 

regular intervals, such as quarterly, unless otherwise dictated by applicable regulations. The 

treatment plan should be revised based on ongoing assessment and evaluation of the plan’s 

effectiveness. The effectiveness of the treatment plan should be based on the patient’s progress 

toward the identified goal and the continued feasibility and appropriateness of the goals and their 

ongoing importance to the individual patient and his or her recovery. The patient’s response to 

treatment determines his/her progression through each treatment stage. While some patients may 

remain in one stage for a considerable period of time, others may rapidly progress through one or 

more of the stages. In addition, it is not uncommon for a patient to relapse. Programs should 

ensure they adequately document all the services a patient receives in the patient’s treatment 

plan. For information on assessment and treatment planning access: 

http://store.samhsa.gov/product/TAP-21-Addiction-Counseling-Competencies/SMA13-4171. 

Patients unsuccessfully treated with methadone or buprenorphine/naloxone maintenance and 

continue the illicit use of opioids as well as patients who have misused benzodiazepines and 

alcohol to the extent that they have an increased risk for opioid overdose should be considered 

for possible opioid antagonist therapy. 

Studies suggest that the duration of retention in treatment is directly related to success in 

outcome. For patients who drop out of treatment, the outcome often is negative, whereas 

patients who remain in treatment, despite continued excessive use of alcohol or illicit drugs, tend 

to benefit from the treatment experience.

Both psychosocial and medical treatment should be of sufficient intensity and duration so as to 

be effective for each treatment stage. In general, a greater intensity of services is desirable at the 

beginning of treatment, or when staff members identify a patient’s relapse or relapse “trigger” 

conditions exist. Many patients often need psychosocial services for an extended period of time 

because of the multiplicity of their problems. 
FEDERAL OPIOID TREATMENT STANDARDS 35

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Unless clinically indicated, there should be no limits on patients’ duration of treatment or dosage 

level of medication. Likewise, there should be no limitations on the psychosocial services 

offered to patients, even when they no longer take medication. 

Programs should make every effort to retain patients in treatment as long as it is clinically 

appropriate, medically necessary, and acceptable to the patient. Maintaining a patient on 

medication, even when psychosocial treatment or other clinic services may not be yielding 

optimum results, is beneficial to both the individual patient and the public health. In addition, 

pharmacotherapy may still benefit patients who no longer need ancillary services.

Co-occurring disorders, which include multiple drug use problems as well as psychiatric and 

medical disorders, are most effectively treated and managed at a single treatment site. If the 

appropriate level of expertise is not available within the program, staff members should arrange 

for the patient to receive appropriate care elsewhere, taking into consideration barriers to 

treatment, e.g., financial and transportation burdens and travel time to and from care. 

Medication-assisted treatment providers should have an understanding of both substance use and 

co-occurring disorders. It is essential for OTPs to develop a referral and consultative 

relationship with a network of agencies and providers capable of providing primary and specialty 

services for the range of psychiatric comorbid conditions, medical complications, and 

communicable diseases that may be part of a patient’s problem list if those services are not 

offered onsite. Increasingly, it is expected that substance abuse and mental health treatment 

programs will integrate medical and behavioral health services into their clinical programs in 

order to address the needs of the whole person receiving treatment services. OTPs may be 

especially well positioned to do this because they are already required to offer medical and 

substance use disorder treatment in a single setting. Information exchange across this network 

must both facilitate treatment and protect patient privacy.

HIV and Hepatitis

Staff members should become knowledgeable about existing and emerging diseases of public 

health interest and educate patients about these conditions. OTPs should continually review and 

be prepared to modify clinical approaches while addressing patients’ related mental health issues 

as the public health environment changes. Examples of these types of diseases include 

tuberculosis, viral hepatitis, and sexually transmitted infections. Programs should ensure that 

each patient has access to low-cost or free immunizations recommended by the CDC. Ongoing 

services should address the medical and emotional well-being of patients on medication-assisted 

treatment. Patients should receive risk assessment; testing (including HIV and viral hepatitis);

and diagnostic workup and medical treatment for infectious and other medical or psychiatric 

problems. In cooperation with the medical and nursing staff, the clinical staff should assess the 

need to include goals related to these health concerns in the treatment plan. Programs should 

coordinate care appropriately with the providers and health departments caring for the patients 

with medical or psychiatric problems, taking into account informed patient consent consistent 

with 42 CFR § 2 if these services will not be offered in the OTP itself. For guidelines on HIV 

and viral hepatitis screening, testing, and treatment, access 
FEDERAL OPIOID TREATMENT STANDARDS 36

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm as well as 

http://www.ncbi.nlm.nih.gov/books/NBK92036. 

Patients with opioid use disorders who receive effective medication-assisted treatment have 

improved adherence to pharmacotherapy for HIV or other medical conditions. OTP staff should 

be able to offer options to patients living with human immunodeficiency virus/acquired 

immunodeficiency syndrome (HIV/AIDS) that maximize the benefits of medication-assisted 

treatment and address medication side effects and toxicity during the course of HIV/AIDS 

treatment. It is important that clinical staff understand issues related to opioid-assisted 

pharmacotherapies and antiretroviral medications, such as the risk for drug-drug interactions 

with some of these therapies as this can be an important consideration in the choice of opioid 

therapy. For further information on opioid interactions with other medications, access

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3334287/. 

Linkages established with community HIV/AIDS treatment, prevention programs and social 

support services facilitate the OTP’s collaboration with a patient’s primary physician and 

supports his/her continuation of medication-assisted treatment. This is especially important 

when HIV infection/AIDS becomes the primary health concern and there is a transfer of care. 

The OTP and the provider responsible for HIV/AIDS medication management work together to 

monitor and case manage medication adherence and adverse events. Programs arrange 

confidential information exchange—consistent with 42 CFR § 2—to ensure that appropriate 

information reaches the providers caring for the patient. For additional information, access: 

http://store.samhsa.gov/product/TIP-37-Substance-Abuse-Treatment-for-Persons-With-HIVAIDS/SMA12-4137. 

As with HIV, patients who test positive for viral hepatitis are referred for further evaluation 

including sexually transmitted infection screening and treatment, if necessary. Patients who test 

negative are immunized against hepatitis A and B, as appropriate. Many patients identified as 

positive for hepatitis C virus (HCV) may benefit from pharmacotherapy, but this determination 

will require a diagnostic workup. An OTP and the agency responsible for HCV and any other 

viral hepatitis medical treatment should work together to monitor and case manage medication 

adherence and adverse events. Formal documented agreements must be in place to ensure that 

the appropriate information reaches the providers caring for the patient. For additional 

information about HCV, access http://store.samhsa.gov/product/TIP-53-Addressing-ViralHepatitis-in-People-With-Substance-Use-Disorders/SMA11-4656. 

Mental Health Disorders 

An OTP identifies patients with mental health needs during the assessment process and refers 

them to appropriate treatment if such treatment is not available onsite. In addition, it monitors 

patients for the emergence of symptoms of mental illness when patients withdraw or are 

discharged from treatment. 

Linkages with mental health providers in the community provide a mechanism for an OTP to 

jointly monitor and evaluate a patient’s use of mental health medication. If possible and when 

indicated, programs may dispense these medications in conjunction with the daily dose of opioid 
FEDERAL OPIOID TREATMENT STANDARDS 37

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

medication. For additional information, access http://store.samhsa.gov/product/TIP-42-

Substance-Abuse-Treatment-for-Persons-With-Co-Occurring-Disorders/SMA13-3992. 

Trauma

According to the December 30, 2010, National Survey of Substance Abuse Treatment Services 

(N-SSATS) report on Mental Health Screenings and Trauma-Related Counseling in Substance 

Abuse Treatment Facilities (http://oas.samhsa.gov/2k10/313/313Trauma2k10Web.pdf), the 

experience of traumatic events and the possible sequela of posttraumatic stress disorder (PTSD) 

often co-occur with a substance abuse disorder and are present among many substance abuse 

treatment patients. Common types of trauma include being exposed to a natural disaster or 

violence in combat or noncombat situations and experiencing childhood, historical, sexual, and 

physical assault or domestic violence. 

Because of the relationship between substance use and trauma-related mental health problems, it 

is recommended that OTPs use mental health screenings and assessments to determine if a 

patient is suffering from a trauma-related illness and/or has been involved in domestic violence. 

The program must be prepared to offer appropriate treatment or refer patients for appropriate 

clinical intervention. For additional information on trauma-informed care, please access

http://store.samhsa.gov/product/TIP-57-Trauma-Informed-Care-in-Behavioral-HealthServices/SMA14-4816. 

Tobacco Use Disorders 

Tobacco use is a source of a great degree of morbidity and mortality for people with opioid use 

disorders. Addressing tobacco use saves lives and is a key part of holistic, individualized 

treatment planning. A growing body of evidence demonstrates that counselors and agencies can 

successfully help patients stop using tobacco, which improves patient health and saves lives. 

Furthermore, recent studies indicate that treating tobacco use actually helps patients address their 

alcohol and other drug problems. Integrating tobacco treatment into the mainstream of substance 

abuse treatment is rapidly becoming a nationwide best practice. (Access 

http://smokingcessationleadership.ucsf.edu/resources/toolkits). OTPs have the advantage of 

being able to prescribe medication-assisted treatment for tobacco use disorders as an ongoing 

part of patient care. 

Alcohol Use Disorders

Alcohol is the most widely used psychotropic substance and its use is common among patients 

receiving medication-assisted treatment. Patients should be counselled against alcohol use while 

on medication-assisted treatment due to its depressant effects, which can interact adversely with 

opioids. For example, alcohol is associated with 22 percent of overdose deaths due to opioid 

pain relievers. Intervention should be provided for alcohol use disorders that by themselves cause 

a great deal of medical harm. Combined with the effects of hepatitis, alcohol can worsen liver 

disease. In addition to addressing alcohol use disorder behaviorally, OTPs should have the 

ability to assess recent use of alcohol via toxicology tests and Breathalyzer results as a means of 

establishing safety for dosing and take-homes. In addition, these tests are integral to assessing 

the need for concurrent treatment of an alcohol use disorder. Because of the availability of staff 

with prescribing authority, OTPs should provide medication-assisted treatment for alcohol use 
FEDERAL OPIOID TREATMENT STANDARDS 38

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disorders, when appropriate, as well as provide counseling interventions for patients with a need 

for treatment. Extended-release injectable naltrexone is the only FDA-approved medication for 

the treatment of both alcohol and opioid use disorders. For additional information, access TIP 

49: Incorporating Alcohol Pharmacotherapies Into Medical Practice

(http://www.ncbi.nlm.nih.gov/books/NBK64041/pdf/TOC.pdf) 

Program staff members are knowledgeable about current, effective strategies for treating alcohol, 

cocaine, and other drugs of abuse. An OTP manages a patient’s concurrent abuse of substances 

other than opioids following the principles described in TIP 43 

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). Even when patients are not 

fully abstinent from all drugs of abuse, they and their communities continue to benefit from 

medication-assisted treatment for opioid use disorders. 

Patients engaging in polydrug abuse must receive careful evaluations. Decisions on the most 

therapeutic course of treatment are based on the patient’s condition and the treatment team’s best 

clinical judgment. Persons with polysubstance use are at increased risk of suicide. For additional 

information on screening for suicide risk and interventions, please visit 

http://www.samhsa.gov/suicide-prevention. Polydrug abusing patients may benefit from 

treatment with other FDA-approved medications. In addition, OTPs coordinate care with 

providers outside of the OTP who prescribe medications with abuse potential. 

Benzodiazepine Use

The use and abuse of benzodiazepines is a growing problem nationally and within medicationassisted treatment populations. Benzodiazepine use that is not legitimately prescribed by a 

provider with whom the program has permission to communicate should be addressed as illicit. 

Benzodiazepines are highly associated with overdose fatalities when combined with opioids. 

Patients known to be using benzodiazepines even by prescription should be counselled as to their 

risk and provided with overdose prevention education and naloxone. For an evidence based 

strategy to address benzodiazepine use among OTP patients, refer to Management of 

Benzodiazepines in Medication-Assisted Treatment: Final Report on the Development of Clinical 

Guidelines

(http://my.ireta.org/sites/ireta.org/files/Best%20Practice%20Guidelines%20for%20BZDs%20in

%20MAT%202013_0.pdf) prepared by the Institute for Research, Evaluation and Training in 

Addictions with Support from Community Care Behavioral Health Organization. 

Chronic Pain 

In accordance with the regulations and treatment guidelines, OTP patients are permitted to 

receive both medication-assisted treatment and adequate doses of opioids or other analgesics for 

pain when medically necessary. OTPs should make careful diagnostic distinctions between the 

physical dependence associated with the chronic administration of opioids for pain relief and an 

opioid use disorder. Patients with co-occurring pain should receive treatment from both pain 

management and addiction medicine specialists who employ a multidisciplinary approach. 

When possible and appropriate, programs refer patients with chronic pain for consultation with a 

specialist in pain medicine. For further guidance, refer to TIP 54: Managing Chronic Pain in 
FEDERAL OPIOID TREATMENT STANDARDS 39

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Adults With or in Recovery From Substance Use Disorders

(http://store.samhsa.gov/shin/content//SMA12-4671/TIP54.pdf).

Aftercare Planning

Aftercare planning should begin upon admission. Taking a recovery oriented approach to care 

facilitates this process. Aftercare planning should include the need for ongoing management of 

medical and psychiatric problems. Untreated, these problems are associated with relapse to drug 

use. Antagonist medications (e.g., extended-release injectable naltrexone) should also be 

considered for inclusion in aftercare plans. For more information, refer to the Clinical Use of 

Extended-Release Injectable Naltrexone in the Treatment of Opioid Use Disorder: A Brief Guide

(http://store.samhsa.gov/shin/content/SMA14-4892/SMA14-4892.pdf). 

RECOVERY ORIENTED SYSTEMS OF CARE

42 CFR § 8.12(f) (5) Counseling services. (i) OTPs must provide adequate substance abuse 

counseling to each patient as clinically necessary. This counseling shall be provided by a 

program counselor, qualified by education, training, or experience to assess the

psychological and sociological background of patients, to contribute to the appropriate 

treatment plan for the patient and to monitor patient progress. 

(ii) OTPs must provide counseling on preventing exposure to, and the transmission of, 

human immunodeficiency virus (HIV) disease for each patient admitted or readmitted to 

maintenance or detoxification treatment. 

(iii) OTPs must provide directly, or through referral to adequate and reasonably accessible 

community resources, vocational rehabilitation, education, and employment services for 

patients either who request such services or who have been determined by the program 

staff to be in need of such services.

Recovery-oriented systems of care (ROSC) are based on the substance use treatment 

community’s concept of recovery and recovery management. Recovery is defined as a 

voluntary, self-directed, ongoing process where patients access formal and informal resources; 

manage their care and their addiction; and rebuild their lives, relationships, and health to lead full 

meaningful lives. While recovery is patient directed, recovery management comprises the 

clinically based structured processes used to coordinate and facilitate the delivery of recovery 

support services after the acute stage of treatment.

The ROSC framework is replacing the traditional approach to the treatment of substance use 

disorders characterized by brief interventions, crisis linked timing, and a focus on abstinence. 

When OTPs adopt the ROSC philosophy, their primary responsibility of dispensing medication 

onsite to treat opioid use disorders expands to include supporting patients’ recovery within their 

own environment. In addition to forming long-term partnerships with patients and their families, 
FEDERAL OPIOID TREATMENT STANDARDS 40

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

other service providers, behavioral healthcare systems professionals, and community groups, 

recovery-oriented programs involve patients in all care decisions and help them identify and 

select the services and support they need at any point in the recovery process. 

OTPs should include recovery support services in their patient’s treatment plan. Recovery 

support services may involve follow-up phone calls; face-to-face meetings; e-mails; and 

connecting patients to peer-to-peer services, 12-step, faith-based, and community groups. 

Furthermore, under the ROSC framework, OTPs provide patients with continuing care. This 

includes a discharge plan, referrals to continuing outpatient care, procedures that address 

patients’ physical and mental health problems following medically supervised withdrawal, plans 

for reentry to maintenance treatment if relapse occurs, and ongoing recovery management. 

OTPs also are encouraged to offer supportive counseling as a transitional service. 

The organized provision of peer recovery support services is a newer concept within the field of 

medication-assisted treatment and a key component of ROSC. Peers are recovering men and 

women who have experienced the challenges and successes of the earlier stages of medicationassisted treatment. These individuals often have more credibility and impact on patients than do 

clinical staff. 

Recovery coaches employed by the OTP help people on their pathway to recovery by providing: 

• Emotional support—demonstrations of empathy, caring, and concern during activities such 

as peer mentoring, recovery coaching, or recovery support group meetings. 

• Informational support—health and wellness information; educational assistance; and help 

acquiring life skills, job training, and citizenship restoration (e.g., voting rights, driver’s 

license).

• Instrumental support—assistance completing tasks, especially those that are stressful or 

unpleasant (e.g., filling out applications, obtaining public benefits), or providing supports 

such as child care and transportation to support group meetings and clothing closets.

• Affiliation support—opportunity to establish positive social connections with others in 

recovery and learn social and recreational skills in an alcohol- and drug-free environment. 

Cultural Competency

Programs are sensitive to the culture and values of patients and offer, as appropriate, treatment 

for groups organized with special needs in mind (e.g., gender, sexual orientation, older adults, 

Spanish language, co-occurring disorders, and developmental disabilities). All program staff, 

either by the OTP’s hiring practices or through training, should be professionally and culturally 

competent and able to work effectively with the local community; accept input from minority 

community members; and/or receive the advice of individuals with knowledge of gender, 

ethnicity, and language issues. In addition, written nondiscrimination policies should ensure 

equal access to treatment for all persons in need, regardless of race, ethnicity, gender, disability, 

age (with specific reference to policies for minors), or sexual orientation, and all printed 
FEDERAL OPIOID TREATMENT STANDARDS 41

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

materials, electronic media, and course offerings should employ unbiased and non-prejudicial 

language.

HIV Prevention 

Programs should develop and implement a plan for educating about and testing patients for 

HIV/AIDS. The information provided may address topics such as HIV/AIDS testing procedures, 

confidentiality, reporting, follow-up care, counseling, safer sex, social responsibilities, universal 

precautions, and sharing of drug injection equipment. 

HCV Prevention

Consistent with resources, OTPs should screen and test for HCV and HBV either directly or by 

referral. Program staff should receive education on and teach patients how to treat and prevent 

the different forms of viral hepatitis, especially HCV, because it is the most common blood 

borne virus among persons who inject drugs. These viruses may affect patients’ health, mental 

health, and dosage levels of opioid medications. Messages patients should receive regarding 

HCV include but are not limited to:

• HCV is four times as prevalent as HIV. 

• You don’t have to look sick to be sick. 

• HCV medications can be given safely with methadone and buprenorphine. 

• Patients can be treated and often cured.

Treatment of Adolescents

For the purpose of this document, adolescents are defined as youth ranging in age from 13 to 18. 

Programs develop and implement policies to ensure that adolescents are provided with 

developmentally appropriate treatment and evidence-based psychosocial support, such as family 

involvement, for that treatment. Screenings and assessments tailored to adolescents ensure that 

medication-assisted treatment is the most appropriate treatment for these patients. 

Criminal Justice Issues

Programs develop procedures to coordinate and communicate with agents of the criminal justice 

system and advocate for the continuous treatment of patients who are incarcerated, on probation, 

or on parole.

Women in Treatment

OTPs’ policies and procedures must reflect the specific needs of female patients and make 

provisions for the respectful and safe treatment of women. The option of single-sex group 

therapy based on gender identity or expression or sexual orientation should be available and each 

OTP’s physical space, including restrooms, should meet the needs of female patients. In 

addition, all staff members should be intensively trained in the characteristics and needs of the 

women participating in their particular program. 
FEDERAL OPIOID TREATMENT STANDARDS 42

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Family Involvement

The involvement of family members contributes to positive treatment outcomes while also 

providing benefits to the family members. It is useful to expand the concept of family to include 

the patient’s social network; significant others; persons in recovery, such as a sponsor; and 

resources from the community including the outpatient provider and others at the patient’s 

request. An OTP provides opportunities for family and significant others to become involved in 

therapy. Some OTPs use short-term groups to educate the family on medication-assisted 

treatment, substance use disorders and their effects on the family, and other family issues. 

Family counseling allows more participants to address their concerns with the patient. When 

appropriate, referrals for family treatment should be made and follow-up to the referrals 

confirmed. If needed, identification of the ongoing need for collaboration should occur with the 

informed consent of the patient and a valid release of information. 

Consistent with best practices for developmentally appropriate treatment, family involvement is 

an expectation of treatment for young adults (18-24 years). Onsite education and training for all 

patients who are parents should be available. Children of patients in medication-assisted 

treatment may have special mental health and cognitive needs, especially if there has been 

physical or sexual abuse or neglect. Children should be permitted inside the treatment program 

under parental supervision. When appropriate, program staff should refer patients who are 

parents to resources and services in parenting skills and child care as well as parent support 

groups. 

OTPs also should provide reproductive health education for all patients and, when needed, make 

appropriate referrals for contraceptive services.

Alternative Therapies

Programs support patient choice in seeking alternative therapies, providing appropriate guidance 

in the process. This may include ensuring the therapies will not cause harm and that 

practitioners are trained/certified/licensed. Also, programs may provide some culturally 

appropriate alternative therapies when there is a need.

Orientation to Treatment

Patients may be in withdrawal or intoxicated during the first days of treatment; therefore, their 

orientation to treatment occurs at the time of admission and when they are stabilized. 

Orientation to treatment comprises continuous education via multiple modalities (e.g., verbal, 

written, video) in individual and/or group settings. Topics include: 

• Signs and symptoms of overdose, use of the naloxone antidote (prescriptions should be given 

to patients on entry into treatment), and when to seek emergency assistance.

• The medication or modality of treatment being used, including side effects and common 

myths, and the expected outcomes. 

• The nature of various addictive disorders. 

• The benefits of treatment and nature of the recovery process, including stages of treatment. 

• An OTP’s guidelines, rules, regulations, fees, and billing procedures. 
FEDERAL OPIOID TREATMENT STANDARDS 43

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• Noncompliance and discharge procedures, including administrative withdrawal from 

medication.

• Patient rights (http://www.nlm.nih.gov/medlineplus/ency/article/001947.htm). 

• Confidentiality and how release of information is permitted in accordance with 42 CFR § 2. 

• Toxicology testing procedures. 

• Dispensation and the appropriate storage of medications when receiving take-homes. 

• HIV-spectrum and other infectious diseases such as HCV, tuberculosis, and sexually 

transmitted infections.

• Potential drug interactions.

• Agreements needed to exchange appropriate information within the network of consultants 

and referral agencies in accordance with HIPAA regulations and 42 CFR § 2. 

• The prescription drug monitoring program (PDMP), if applicable, and how the OTP utilizes 

it.

• Central registries and how programs utilize them.

Substance Abuse Counseling

Appropriately trained, experienced, and certified or licensed substance abuse counselors should 

provide services at the intensity and for the duration required to meet each patient’s needs as 

referenced in the individualized treatment plan. While there are no set patient-to-staff ratios 

specified in the federal regulations, states have set patient-to-staff ratios as high as 75:1 and as 

low as 30:1. States allow for an increase in the ratio under certain circumstances. Staff ratios 

should be sufficient to ensure that patients have reasonable and prompt access to counselors and 

receive counseling services at the required levels of frequency and intensity. An OTP’s staffing 

of counselors is based on the characteristics and needs of particular patient populations and state 

requirements. 

Twelve-Step or Other Mutual-Help Groups 

The use of 12-step or other mutual-help groups should be encouraged. Sometimes, these groups 

are unfamiliar with opioid addiction treatment. OTPs can establish their own 12-step or other 

mutual-help programs and should identify those groups that are accepting of maintenance with 

appropriate medications. 

Counseling for HIV, Hepatitis, and Other Infectious Diseases 

OTPs should provide patients with counseling on HIV and other prevalent infectious diseases, 

such as hepatitis, sexually transmitted infections, and tuberculosis. Counseling also should 

include infectious disease prevention and risk reduction education for at-risk patients and 

emphasize the need for patients to adhere to treatment and communicate honestly with the 

provider when treatment has begun. 

Medical Services

It is highly recommended, but not required, that OTPs provide basic primary care onsite. OTP 

physicians can prescribe medication as appropriate for co-occurring medical and psychiatric 

disorders. 
FEDERAL OPIOID TREATMENT STANDARDS 44

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Program staff should provide care coordination, making referrals for medical and psychiatric 

treatment when indicated. The staff members responsible for establishing linkages with other 

healthcare organizations and practitioners should be knowledgeable about pharmacotherapy 

treatment (e.g., drug interactions, acute withdrawal, and overdose), actively seek patient consent 

to talk with other providers, and check their state’s PDMP. 

OTPs may determine that directly observed therapy may enhance patients’ compliance with their 

regimen for psychotropic medications, which may be subject to abuse, and medications for 

illness and chronic health conditions. These medications may be dispensed with the daily opioid 

dose. 

TESTING AND SCREENING FOR DRUG USE

42 CFR § 8.12(f) (6). Drug abuse testing services. OTPs must provide adequate testing or 

analysis for drugs of abuse, including at least eight random drug abuse tests per year, per 

patient, in maintenance treatment, in accordance with generally accepted clinical practice. 

For patients in short-term detoxification treatment, the OTP shall perform at least one 

initial drug abuse test. For patients receiving long-term detoxification treatment, the 

program shall perform initial and monthly random tests on each patient.

Clinical drug testing is used for the purposes of diagnosis, monitoring, and evaluating progress in 

treatment and the promotion of long-term recovery. Through drug testing, patients’ use of 

specific drugs as well as the absence of prescribed medications, which may be an indication of 

diversion, can be identified. After the patient’s initial drug test at admission, clinicians should 

determine the frequency of toxicological testing by evaluating the clinical appropriateness in 

relation to the patient’s stage of treatment. All maintenance patients must receive a minimum of 

eight toxicology tests per year. The results of toxicological tests are an essential component in 

making decisions regarding take-home medication privileges; however, treatment decisions 

should not be based solely on toxicology screening results.

Although testing panels typically include opioids (including prescription opioid analgesic 

compounds), benzodiazepines, barbiturates, cocaine, marijuana, methadone (and its metabolites), 

buprenorphine, amphetamines, and alcohol, they are not limited to these substances. Clinicians 

should determine the drug-testing regimen by analyzing community drug-use patterns and 

individual medical indications. It is strongly recommended that benzodiazepines, barbiturates, 

and alcohol (using the ethyl glucuronide test) be included in drug screening and testing panels. 

Alcohol is the most widely used mood-altering substance in the United States, and 

benzodiazepines and barbiturates are often prescribed for detoxification and chronic seizure 

disorders. Detection of benzodiazepines, barbiturates, or alcohol is important in ongoing 

assessment, treatment planning, and medication management. 

OTPs often perform onsite point of collection (POC) tests using sensitive and automated 

immunoassay (IA) technologies that screen urine or oral fluid samples for a relatively narrow 
FEDERAL OPIOID TREATMENT STANDARDS 45

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

range of drug classes (e.g. amphetamines, barbiturates, benzodiazepines, opioids) and a limited 

number of specific drugs. POC tests such as IAs have a place in clinical decision making, but 

are not by themselves adequate to satisfy the regulatory requirements for drug use testing 

services. 

Laboratory testing affords the opportunity to obtain confirmation testing such as gas 

chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LCMS) or tandem mass-spectrometry (LC-MS/MS.) This should form part of the OTP’s established 

procedures for addressing potentially false positive and false negative urine or other toxicology 

test results as described in Chapter 9 in TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). 

Urine or other toxicological specimens are collected in a therapeutic context that suggests trust 

and respect and minimizes falsification. Reliance on direct observation is neither necessary nor 

appropriate for all patients. 

The physician or authorized healthcare professional interpreting toxicology results must have 

knowledge of physiological issues and a thorough understanding of the differences among 

laboratories and the factors that affect absorption, metabolism, and elimination of opioids and 

other drugs. 

All OTP treatment personnel must understand the benefits and the limitations of toxicological 

testing procedures. In order for toxicology testing to be an effective therapeutic tool, OTPs must 

promptly address the results with patients and document both the results of toxicology tests and 

follow-up therapeutic interventions in the patient record. Clinicians should rapidly intervene to 

therapeutically address the disclosure of illicit drug use, a positive drug test, or possible diversion 

of opioid medication, as evidenced by the absence of opioids or related metabolites in drug 

toxicology test results. 

Note: While federal regulations require initial toxicology screening and eight additional screens 

per year for patients enrolled in comprehensive maintenance therapy, patients on long-term 

detoxification are required to have testing monthly. For additional information, refer to TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf and TAP 32 Clinical Drug 

Testing in Primary Care (http://store.samhsa.gov/shin/content//SMA12-4668/SMA12-4668.pdf). 

RECORDKEEPING AND DOCUMENTATION

42 CFR § 8.12 (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 opioid drugs approved for use in treatment of opioid addiction. All records are 

required to be kept confidential in accordance with all applicable Federal and State 

requirements. 
FEDERAL OPIOID TREATMENT STANDARDS 46

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

(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 review whether the patient 

is enrolled any other OTP. A patient enrolled in an OTP shall not be permitted to obtain 

treatment in any other OTP except in exceptional circumstances. If the medical director or 

program physician of the OTP in which the patient is enrolled determines that such 

exceptional circumstances exist, the patient may be granted permission to seek treatment 

at another OTP, provided the justification for finding exceptional circumstances is noted in 

the patient’s record both at the OTP in which the patient is enrolled and at the OTP that 

will provide the treatment.

All records required by 42 CFR § 8.12(g) should be retained for a minimum of 3 years. It is 

strongly recommended that a program implement an electronic health record (EHR) system. 

Patient Records

Patient records must be kept confidential and up to date. All entries must be legible and 

organized in a manner that facilitates access to specific elements of the record and document 

individual patient treatment outcomes. As required by HIPAA, patients have a right to access 

their medical records and other health information. 

Programs must adhere to all requirements of the federal confidentiality regulations (42 CFR § 2) 

and HIPAA privacy, security, and breach notification regulations (45 CFR § 160 and § 164), as 

applicable. 

In accordance with 42 CFR § 2, programs should have clear guidelines for the access, transfer, 

and disposal of records. They also should have record-retention policies and safeguards for the 

destruction of old containers, labels, printouts, and program records under normal operating 

conditions as well as in the event of a disaster or program closure. 

Records of the identity, diagnosis, prognosis, or treatment of any patient that are maintained in 

connection with any activity relating to substance abuse education, prevention, training, 

treatment, or research that is conducted, regulated, or directly or indirectly assisted by any 

department or agency of the program shall, except as provided in subsection (e) of 42 CFR § 2, 

be confidential. Information in these records can be disclosed only for the purposes or 

circumstances expressly authorized under subsection 42 CFR § 2(b). 

Programs may use standard intake forms or identical data elements when possible. Programs 

should be efficient and avoid duplication in recordkeeping. At the same time, the program

gathers sufficient data for outcome, cross-site, or other evaluations or studies or to support 

managed care data requirements. An individual patient record is typically comprised of: 

identification and basic demographic data and results of the screening process. In lieu of patient 

identification data, each file may bear a unique identifying code that gives reliable access to such 

required identification information. All information should be accessible and understandable to 

appropriate authorities and consistent with 42 CFR § 2 and HIPAA privacy regulations. 
FEDERAL OPIOID TREATMENT STANDARDS 47

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

An individual patient record should contain: 

• Documentation of compliance with the approved central registry system (if applicable) or an 

alternative mechanism to avoid dual registration.

• The initial assessment report.

• Narrative bio-psycho-social history prepared within approximately 30 days of the patient’s 

admission or as required by state regulation.

• Medical reports, including results of the physical examination; past and family medical 

history; nursing notes; laboratory reports, including results of regular toxicology screens, a 

problem list, and list of medications updated as clinically indicated; and progress notes, 

including documentation of all medications and dosages. Information in the medical record 

is entered by physicians and authorized healthcare professionals, as appropriate. 

• Dated case entries of all significant contacts with patients, including a record of each 

counseling session, in chronological order. 

• Dates and results of patient case conferences.

• The treatment plan and any amendments to it; quarterly reviews; and updates of the 

assessment and treatment plan for the first year of continuous treatment; and in subsequent 

years, semiannual assessments; treatment plan updates; and counselor summaries, which 

include an evaluation of the existing treatment plan and the patient’s response to treatment.

• Documentation that all services listed in the treatment plan are available and actually were 

provided or that the patient was referred to such services. 

• A written report on the process used to make patient treatment decisions, such as privileges 

or changes in counseling sessions, frequency of drug tests, or any other significant treatment 

changes, either positive or negative, and the factors considered in the decisions. 

• A record of correspondence with patient, family members, and other individuals. 

• A record of each referral for service and the results.

• Documentation that the patient received a copy of the program’s rules and regulations and a 

statement of patient rights and responsibilities and that these items were discussed with her or 

him.

• Consent forms; release(s) of information; and prescription, travel, employment, and takehome documentation. 
FEDERAL OPIOID TREATMENT STANDARDS 48

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• A closing summary, including reasons for discharge and any referrals. In the case of death, 

the cause of death is documented. 

• The PDMP reports, unless operating in a state with no PDMP. 

Records for the Storage, Dispensing, and Administration of Opioid Medication 

OTPs’ policies and procedures must be consistent with DEA statutes and regulations pertaining 

to the recording of and accounting for the use of controlled substances. Other medications must 

be stored separately from methadone and buprenorphine. Medication orders and changes in 

dosage are written on an acceptable order sheet and signed by the physician or comparable 

electronic process.

As part of the process to create a perpetual and accurate inventory of all in-stock medications, 

including controlled substances, every dose administered or dispensed is captured electronically 

or recorded on an administration sheet at the time the medication is administered or dispensed 

and recorded on the patient’s individual medication dose history. The qualified person 

administering or dispensing the medication either signs or initials each notation. If initials are 

used, the full signature of the qualified person administering or dispensing the medication 

appears at the bottom of each page of the medication sheet. The number of dispensed 

medication doses is totaled in milligrams on a daily basis. Programs must calibrate their 

medication-dispensing instruments according to the manufacturer recommendations to ensure 

accurate patient dosing and medication tracking.

Multiple Program Enrollment Prevention

Reasonable measures are taken to prevent patients from enrolling in treatment provided by more 

than one clinic or individual practitioner. These measures are commensurate with the severity of 

the problem and the documented consequences. In some cases, an OTP may, after obtaining 

patient consent, contact other OTPs within a reasonable geographic distance (100 miles) to verify 

that a patient is not enrolled in another OTP. For guidance, access the regulation at

http://www.ecfr.gov/cgi-bin/textidx?SID=07521f1d15ff4661f403ec736facfdb7&node=42:1.0.1.1.2.3.1.4&rgn=div8. 

GUIDELINES FOR THERAPEUTIC DOSAGEAND ADMINISTRATION

42 CFR § 8.12 (h) Medication administration, dispensing, and use. (1) OTPs must ensure 

that opioid agonist treatment medications 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 opioid drugs, or by an agent of such a 

practitioner, supervised by and under the order of the licensed practitioner. This agent is 

required to be a pharmacist, registered nurse, or licensed practical nurse, or any other 

healthcare professional authorized by Federal and State law to administer or dispense 

opioid drugs.
FEDERAL OPIOID TREATMENT STANDARDS 49

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

(2) OTPs shall use only those opioid agonist treatment medications 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 opioid addiction. 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 opioid addiction. Currently, the following opioid 

agonist treatment medications will be considered to be approved by the Food and Drug 

Administration for use in the treatment of opioid addiction:

(i) Methadone; and

(ii) Levomethadyl acetate (LAAM);

(iii) Buprenorphine and buprenorphine combination products that have been approved for 

use in the treatment of opioid addiction. 

(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 abuse.

(ii) For each new patient enrolled in a program, the initial dose of methadone shall not 

exceed 30 milligrams and the total dose for the first day shall not exceed 40 milligrams, 

unless the program physician documents in the patient’s record that 40 milligrams did not 

suppress opiate abstinence symptoms.

(4) OTPs shall maintain current procedures adequate to ensure that each opioid agonist 

treatment medication used by the program is administered and dispensed in accordance 

with its approved product labeling. Dosing and administration decisions shall be made by 

program physician familiar with the most up-to-date product labeling. These procedures 

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.
FEDERAL OPIOID TREATMENT STANDARDS 50

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

PHARMACOTHERAPY

The delivery of care in OTPs has been impacted by the availability of multiple

pharmacotherapies. When pharmacotherapy is indicated, it is the responsibility of OTPs to 

match each patient to the appropriate medication even if it is not offered at the OTP. The choice 

of pharmacotherapy should reflect sound medical reasoning as applied to the specific patient. 

Programs providing treatment with multiple medications using both the OTP and office-based 

opioid treatment (OBOT) models of service delivery should develop clear policies and 

procedures for assigning patients to a specific model and establish criteria for determining a 

specific pharmacotherapy. 

Appropriate OTP staff are authorized to dispense or administer methadone and buprenorphine to 

patients admitted for treatment. The federal opioid treatment standards apply equally to both 

methadone and buprenorphine with the sole difference spelled out in 42 CFR § 8.12(i)(3). Other 

pharmacotherapies may be provided in a manner consistent with the best medical practices for 

each medication. For example, the use of extended-release injectable naltrexone is clinically 

appropriate for some patients presenting to OTPs and is not subject to these regulations. 

Physicians who have obtained waivers to prescribe buprenorphine under the rules spelled out in 

DATA 2000 may prescribe buprenorphine to the number of patients specified in the law. A 

physician may treat patients under DATA 2000 rules in an OTP facility, but the OTP must 

clearly distinguish between patients who are cared for by a physician in accordance with the 

rules under DATA 2000 and those who are cared for in an OTP facility in accordance with 42 

CFR § 8.12. 

General Dosage Principles

When a state PDMP is available, OTP physicians and other healthcare providers, as permitted, 

should register to use their respective state’s PDMP and query it for each newly admitted patient 

prior to initiating dosing. The PDMP should be checked periodically (for example, quarterly) 

through the course of each individual’s treatment and, in particular, before ordering take-home 

doses as well as at other important clinical decision points. Querying the PDMP will result in a 

range of possible results. In some cases, no use of scheduled prescription medications will be 

identified. In others, the history of prescription use reported by the patient will be confirmed. If 

the patient has ongoing relationships with prescribers from whom they may still acquire 

prescriptions for controlled substances or other psychotropics, strategies to prevent or limit this 

activity should be established. Ideally, releases of information should be obtained from each 

prescriber in order to coordinate needed medical care while avoiding the use of medications that 

may interact with the pharmacotherapy for a substance use disorder. Lastly, the PDMP may 

reveal ongoing receipt of prescriptions not reported to the program for substances known to be 

misused by the patient. An assertive strategy of care coordination combined with additional 

treatment strategies, such as medically supervised withdrawal from the misused prescription 

medications and intensive behavioral interventions, may need to be implemented. In some 

situations, the presence of active diversion may lead to discharge for reasons of patient safety or 

the safety of the community. Of particular concern is when a patient refuses to sign a release of 

information to allow care coordination with other prescribers.
FEDERAL OPIOID TREATMENT STANDARDS 51

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

OTP safety policy and procedures should include checking the PDMP prior to admitting a patient 

as well as periodically while the patient is enrolled in treatment. Additional information about 

PDMPs can be found at http://captus.samhsa.gov/access-resources/briefing-prescription-drugmonitoring-program-pdmp-effectiveness. 

The program physician is the only practitioner authorized to order and/or change a patient’s 

dosage of methadone or buprenorphine. The physician must make an individualized decision 

informed by the up-to-date product labeling and clinical judgment. 

Standing orders are defined as orders that apply equally to all persons fulfilling certain criteria. 

Examples of standing orders in general medical practice are those that allow influenza 

immunization to be administered to all patients who meet specific criteria. Another example is 

the standing order that allows cardiopulmonary resuscitation to begin when a patient in the 

hospital experiences cardiac arrest. This is why “do not resuscitate” must be written as an order, 

otherwise resuscitation is conducted as per the standing order. 

Standing orders regarding the dose, schedule, or re-administration of methadone are not 

appropriate because of the unique pharmacologic properties, the well-established potential for 

fatalities in the induction period, and the risk of relapse during medically supervised withdrawal. 

In an OTP, an unacceptable standing order is any formulaic policy generically applied to all 

patients meeting specific criteria or in specific situations without evaluation by a physician or 

other qualified healthcare provider. Common examples are dose adjustments made solely on the 

basis of a Clinical Opioid Withdrawal Scale (COWS) score and remedicating a patient who 

vomits after dosing based on the time between dose administration and vomiting using a fixed 

percentage of the dose. 

The physician may choose to write a very short cascading order incorporating a COWS score or 

other objective measure in order to titrate the dose of a specific individual if appropriately 

trained and qualified staff (as determined by licensing criteria or credentialing) are available to 

evaluate the ongoing appropriateness of the physician’s treatment plan and recognize the need 

for the patient to be re-evaluated prior to completion of the full course of the order. The 

physician must document the evidence and assessment supporting the planned use of a cascading 

order whenever one is use. The program as a whole needs to be acutely aware of the added risk 

to the patient such orders represent. 

Program-wide dosage caps or ceilings are contrary to the current state of the medical literature 

and the principle of individualized treatment. Programs should eliminate their use. In addition, 

OTPs should avoid establishing procedures or policies that hinder the ability of physicians or 

authorized healthcare professionals, as appropriate, to adjust patient dosages whenever the need 

is indicated.

Effective medication-assisted treatment has the following desired outcomes: 

• Prevention of the onset of subjective and/or objective signs of opioid abstinence syndrome 

for at least 24 hours (opioid agonists).
FEDERAL OPIOID TREATMENT STANDARDS 52

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• Reduction or elimination of drug craving routinely experienced by the patient (opioid 

agonists or antagonists). 

•

• Blockage of the euphoric effects of any illicitly acquired, self-administered drug without the 

patient experiencing or observers noticing undesirable effects (opioid agonists or 

antagonists). 

The initial full-day dose of medication is based on the physician’s assessment of the patient’s 

overall condition. The physician must take into account the overall medical and psychiatric 

condition of the patient; the patient’s risk for undiagnosed complicating conditions based on 

behavior, family history, age, and gender; the patient’s life history and current substance use; and 

any physical finding on examination. The physician should take into account local conditions, 

such as the relative purity of available drugs and the source of the drugs, regardless of whether 

the patient illicitly purchased or obtained them from friends or family members. Medication 

dosage must also take into account over-the-counter (OTC) drugs, prescription medications, and 

prescription medications containing controlled substances. For a full discussion of appropriate 

dosing with methadone, refer to TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf), and for buprenorphine, refer to

TIP 40 (http://www.ncbi.nlm.nih.gov/books/NBK64245/pdf/TOC.pdf). 

Regulations stipulate that the initial dose of methadone should not exceed 30 mg. The physician 

must document the carefully thought out justification for exceeding 30 mg. The total amount of 

methadone administered on day one must not exceed 40 mg.

Methadone has a long half-life and accumulates in the body with repeated dosing. The full effect 

of a single dose increase may not be appreciated for several days. Consequently a “start low and 

go slow” approach to induction or increases needed at any time during treatment is urged. For 

more information on the pharmacologic properties of methadone and how they guide clinical 

decision making, refer to TIP 43 (http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). 

The total dose of medication and the interval between doses may need to be adjusted for patients 

with comorbid health conditions or atypical metabolic patterns, or if the patient takes other 

prescribed medications that have detectably altered the rate at which the opioid medication is 

metabolized.

Programs must not adjust medication doses to reinforce positive behavior or to punish negative 

behavior. For example, a patient’s noncompliance with a treatment plan, including a positive 

toxicology screen, should not result in a decreased dosage. Such a situation may actually 

indicate the need for an increased dosage.

Medication-assisted treatment should continue as long as the patient desires and derives benefit 

from treatment. There should be no fixed length of time in treatment. For some patients, 

indefinite medication-assisted treatment may be clinically indicated. 
FEDERAL OPIOID TREATMENT STANDARDS 53

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Initial doses of buprenorphine and methadone should be based on the package insert. The 

physician will document the justification for any deviations from this principle.

If a program switches from one generic formulation to another and differences in the effective 

dose cause clinically relevant complaints, the physician needs to assess the patient and adjust the 

medication dosage. Additionally, caution should be exercised when a patient has missed several 

doses of medication because his/her tolerance may have changed. Under no circumstances 

should standing orders be used to address these situations. 

The program should have the capability to obtain medication blood levels when clinically 

indicated. 

UNSUPERVISED APPROVED USE (TAKE-HOME) OF MEDICATION

42 CFR § 8.12 (h) (4) (i) Unsupervised or “take-home’’ use. To limit the potential for 

diversion of opioid agonist treatment medications to the illicit market, opioid agonist 

treatment medications dispensed to patients for unsupervised use shall be subject to the 

following requirements.

(1) Any patient in comprehensive maintenance treatment may receive a single take-home 

dose for a day that the clinic is closed for business, including Sundays and State and 

Federal holidays.

(2) Treatment program decisions on dispensing opioid treatment medications to patients 

for unsupervised use beyond that set forth in paragraph (i) (1) of this section, shall be 

determined by the medical director. In determining which patients may be permitted 

unsupervised use, the medical director shall consider the following take-home criteria in 

determining whether a patient is responsible in handling opioid drugs for unsupervised 

use.

(i) Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol; 

(ii) Regularity of clinic attendance;

(iii) Absence of serious behavioral problems at the clinic;

(iv) Absence of known recent criminal activity, e.g., drug dealing; 

(v) Stability of the patient’s home environment and social relationships; 

(vi) Length of time in comprehensive maintenance treatment; 
FEDERAL OPIOID TREATMENT STANDARDS 54

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

(vii) Assurance that take-home medication can be safely stored within the patient’s home; 

and 

(viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency 

of clinic attendance outweighs the potential risks of diversion.

(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 responsible in handling opioid drugs, the 

following restrictions apply:

(i) During the first 90 days of treatment, the take-home supply (beyond that of paragraph 

(i) (1) of this section) is limited to a single dose each week and the patient shall ingest all 

other doses under appropriate supervision as provided for under the regulations in this 

subpart.

(ii) In the second 90 days of treatment, the take-home supply (beyond that of paragraph (i) 

(1) of this section) is two doses per week. 

(4) No medications shall be dispensed to patients in short-term detoxification treatment or 

interim maintenance treatment for unsupervised or take-home use.

(5) 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 take-home supplies are packaged in a

manner that is designed to reduce the risk of accidental ingestion, including child-proof 

containers (see Poison Prevention Packaging Act, Public Law 91-601 (15 U.S.C. 1471 et 

seq.)).

Note: In the context of 42 CFR § 8.12(i)(5) “container” refers to a child-proof medication bottle. 

Take-home medication is a valuable therapeutic tool and an important means of individualizing 

treatment. Program policies that do not permit take-homes for any patients are unacceptable 

because these policies preclude individualized patient care. Take-home medication often is a 

critical issue for patients who are deciding whether to enter into and remain in treatment. The 

OTP medical director, therefore, should ensure that policies for the approval of take-home 

medication do not create barriers to patients continuing in treatment.

A multidisciplinary team, typically led by the primary clinician, assembles the documentation 

that a given patient has meaningfully fulfilled the eight take-home criteria and has done so for a 

period sufficiently long to suggest likely ongoing compliance. If on methadone, the patient also 
FEDERAL OPIOID TREATMENT STANDARDS 55

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

must meet the time-in-treatment requirements for the level of take-homes being considered. The 

team provides a summary of the documentation, makes recommendations regarding the patient’s 

ability to responsibly handle unsupervised use of medication, and attests that the therapeutic 

benefit outweighs any risk of diversion to the medical director. The medical director considers 

this information and his or her own assessment of the patient to make the final decision to 

approve or reinstate a patient’s use of take-home medication. 

The OTP medical director and program staff should take into consideration the best interest of 

each patient when customizing take-home medication schedules. Public health issues (e.g., 

preventing diversion, ensuring safe storage and security of medication, preventing overdoses) 

also are considered when determining a patient’s eligibility for take-homes. Physicians and OTP 

staff periodically, and when clinically necessary, review a patient’s unsupervised use of 

medication and document their decisions and actions in the patient’s record. 

Patients who need to travel but do not meet criteria for take-home medications should be 

considered for guest dosing. Guest dosing is not specifically provided for in the regulations but 

is consistent with SAMHSA’s approach to both medication safety and supporting recovery. A 

sample policy for guest dosing was developed by the American Association for the Treatment of 

Opioid Dependence. 

Whenever a physician wishes to deviate from the federal opioid treatment standards regarding 

unsupervised use of medication set forth in 42 CFR § 8.12, an OTP must submit an Exception 

Request and Record of Justification form (SMA-168) to SAMHSA for approval. The two most 

common reasons for submitting an exception request are to temporarily increase the number of 

take-home doses otherwise permitted for a patient for unsupervised use or when a patient does 

not meet the time-in-treatment or eight-point criteria for receiving take-home doses. On 

occasion, a trusted third-party may need to be involved in the management of an individual’s 

take-home medication, whether as a condition of receiving an exemption from take-home dose 

requirements or to deliver dispensed doses to the individual patient’s care givers in a skilled 

nursing facility or correctional institution. Programs should develop a standard process to record 

chain-of-custody of dispensed take-home doses. A sample form is provided in the appendices of 

this document. 

OTPs monitor patients’ use of take-home medications in a manner that complies with federal

regulations. Monitoring patients’ use of take-home medication ensures the security of the 

medications and serves as a mechanism for preventing diversion. As part of a program’s policies 

related to medication security, patients are informed of their rights and the responsibility they 

have to store take-home opioid medications in a child-proof container in a secure location. 

Monitoring patients receiving medication for unsupervised use requires the physician or 

authorized healthcare professional, as appropriate, to have knowledge of physiological issues and 

a thorough understanding of the differences among laboratories and the factors that affect 

absorption, metabolism, and elimination of opioids. Knowledge and understanding in these 

areas are essential, for example, to interpret a negative methadone and/or a toxicology test for 

methadone metabolites.
FEDERAL OPIOID TREATMENT STANDARDS 56

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Medication Security

Guidelines for Security of Take-Home Medication: Patients receiving unsupervised (take-home) 

medication should use a locked container to inconspicuously and safely transport take-home 

medication packaged in individual bottles that are labeled in accordance with the regulations and 

store the medication at home. The regulations do not mandate that patients use a specific type of 

locking container. 

Although the locking container is a reasonably safe place for the medication at home, it presents 

two regulatory challenges when transporting the medication from the program to the patient’s 

home: (1) if the locked container is publicly visible, it may offer a means to identify someone in 

treatment and violate patient confidentiality; and (2) the container’s visibility may identify the 

patient possessing take-home medication and place the patient at risk for robbery or assault. 

For ease of discrete transport home, OTPs should dispense dry medication diskettes or tablets in 

one single bottle to patients who report to the clinic once or twice per month and receive 15- to 

30-day supplies of medication. Programs also should consider medication diskettes or tablets for 

patients using air transportation. Dispensing dry medications mitigates any potential for 

bacterial growth in liquid media.

Provision of Medication to Patients Who Are Incarcerated, in Residential Treatment, 

Medically Compromised, or Homebound 

During the course of medication-assisted treatment, there may be occasions when a patient is 

unable to report to the program for routine observed ingestion of medication. This absence may 

occur because of illness, pregnancy, incarceration, participation in residential treatment, lack of 

transportation, and the like. When these situations occur, continuing the patient’s treatment 

safely while also ensuring appropriate handling and delivery of medication to the patient is a 

challenge for clinical staff. One solution is to use a chain-of-custody record, which is a 

document containing the signatures of all people who have handled the medication (see page 78 

in Appendix D. Samples of Standard Forms). This record also should contain spaces for the 

patient to initial each day that the medication is administered, as well as spaces for the initials of 

the person who administered the medication. The patient and the person administering the 

medication should contact the program immediately if the medication seems altered in any way.

When the patient is unable to report to the program as required, a responsible person maintains a 

chain-of-custody record and takes charge of the medication, placing it under lock and key at the 

offsite location. The same holds true for incarceration facilities and nursing homes that do not 

have methadone in stock. Because, at the time of this writing, an individual patient may not 

return unused controlled substance prescription medication to the OTP, the program should have 

a procedure to ensure medications are disposed of in a manner that does not allow the controlled 

substances to be diverted for illegal use.

To get permission for a family member who does not have a history of an alcohol or drug use 

disorder and with whom the OTP staff members have met and screened to pick up the 

medication for patients who are homebound, the OTP should use the SMA-168 and forward the 

exception request to the relevant state and federal government authorities. 
FEDERAL OPIOID TREATMENT STANDARDS 57

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

INTERIM MAINTENANCE

42 CFR § 8.12 (j) Interim maintenance treatment. (1) The program sponsor of a public or 

nonprofit private OTP may place an individual, who is eligible for admission to 

comprehensive maintenance treatment, in interim maintenance treatment if the 

individual cannot be placed in a public or nonprofit private comprehensive program within 

a reasonable geographic area and within 14 days of the individual's application for 

admission to comprehensive maintenance treatment. An initial and at least two other

urine screens shall be taken from interim patients during the maximum of 120 days 

permitted for such treatment. A program shall establish and follow reasonable criteria for 

establishing priorities for transferring patients from interim maintenance to 

comprehensive maintenance treatment. These transfer criteria shall be in writing and

shall include, at a minimum, a preference for pregnant women in admitting patients to 

interim maintenance and in transferring patients from interim maintenance to 

comprehensive maintenance treatment. Interim maintenance 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 State health officer when a patient begins interim 

maintenance treatment, when a patient leaves interim maintenance treatment, and 

before the date of mandatory transfer to a comprehensive program, and shall document 

such notifications. 

(3) SAMHSA may revoke the interim maintenance authorization for programs that fail to 

comply with the provisions of this paragraph (j). Likewise, SAMHSA will consider revoking 

the interim maintenance authorization of a program if the State in which the program 

operates is not in compliance with the provisions of §8.11(g). 

(4) All requirements for comprehensive maintenance treatment apply to interim 

maintenance treatment with the following exceptions: (i) The opioid agonist treatment 

medication is required to be administered daily under observation; (ii) Unsupervised or 

“take-home” use is not allowed; (iii) An initial treatment plan and periodic treatment plan 

evaluations are not required; (iv) A primary counselor is not required to be assigned to the 

patient; (v) Interim maintenance cannot be provided for longer than 120 days in any 12-

month period; and (vi) Rehabilitative, education, and other counseling services described 

in paragraphs (f)(4), (f)(5)(i), and (f)(5)(iii) of this section are not required to be provided to 

the patient.
FEDERAL OPIOID TREATMENT STANDARDS 58

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Mortality among individuals wait-listed for medication-assisted treatment is high. Rather than 

maintaining a waiting list for admission, program should consider offering interim maintenance. 

Provision of interim maintenance requires authorization from SAMHSA. For instructions on 

how to obtain authorizations refer to 42 CFR § 8.11(g). All of the requirements for 

comprehensive maintenance treatment apply to interim maintenance treatment with the following 

exceptions: no take-home doses are permitted; an initial and periodic treatment plan are not 

required; a primary counselor is not required; and the rehabilitative and other services described 

in 42 CFR § 8.12(f)(4), (f)(5)(i) and (f)(5)(iii) are not required. Interim maintenance cannot be 

provided for more than 120 days in any 12-month period. To receive interim maintenance, a 

patient must be fully eligible for admission to comprehensive maintenance. Interim maintenance 

treatment is for those patients who cannot be enrolled in comprehensive maintenance treatment 

in a reasonable geographic area within 14 days of application for admission. During interim 

maintenance, the initial toxicology and at least two additional toxicology screening tests should 

be obtained. 

Programs offering interim maintenance must develop clear policies and procedures governing 

the admission to interim maintenance and transfer of patients to comprehensive maintenance. 

Consideration should be given to the offering of interim maintenance with access to antagonist 

therapy and the transfer of patients to comprehensive maintenance. Priorities such as admission 

for pregnant women should be established. 

EXEMPTIONS

(h) Exemptions. An OTP may, at the time of application for certification or any time 

thereafter, request from SAMHSA 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 wishes to treat a limited number of 

patients in a non-metropolitan area with few physicians and no rehabilitative 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. SAMHSA will approve or deny such exemptions at the time of 

application, or any time thereafter, if appropriate. SAMHSA shall consult with the 

appropriate State authority prior to taking action on an exemption request.

Any deviation from the opioid treatment standards put forth in 42 CFR § 8.12 requires the 

submission and approval of an Exception Request and Record of Justification (SMA-168) form 

that can be accessed via http://www.dpt.samhsa.gov/pdf/SMA-168.pdf. 

Exception Request and Record of Justification (SMA-168) Form 

On occasion, patients may need exceptions from the federal opioid treatment standards due to 

transportation hardships, employment, vacation, medical disabilities, etc. In these instances, the 

physician should submit the completed SMA-168 form to SAMHSA and, if applicable, the 
FEDERAL OPIOID TREATMENT STANDARDS 59

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

SOTA, for approval to change the patient’s dosing regimen from the requirements specified in 

42 CFR § 8.12. At times, it may be necessary to involve a trusted third-party in the management 

of take-home doses in order to receive the exemption. In this case, each program is encouraged 

to develop a standard process for monitoring the chain of custody of take-home medications. 

Failure to submit an SMA-168 exception request to and obtain approval from SAMHSA and, if 

applicable, the SOTA, prior to providing care that deviates from the federal opioid treatment 

standards constitutes a serious regulatory violation, which may threaten a program's federal and 

state compliance, accreditation, and certification.

SMA-168 exception requests may be submitted to SAMHSA on-line, by fax, or by mail. For 

fastest processing, SAMHSA strongly recommends on-line submission. SAMHSA's decision on 

on-line exception requests is typically viewable by the submitting OTP within one hour of 

submission. 

The most common reasons for submitting exception requests are to request: 

• A temporary increase in the number of take-home doses permitted for unsupervised use. 

• A change to the detoxification standards outlined in the regulation. 

Eligible patients may be provided take-home medication according to this schedule with no 

exception request required. In cases where a treating physician believes it would be in the best 

interest of an individual patient to receive a temporary increase in the number of take-home 

medications, such as when there is a family or health emergency, approval of an SMA-168

exception request by SAMHSA and, if applicable, the SOTA, is required. 

It should be noted that the take-home schedule defined in 42 CFR § 8.12(i)(3) represents a 

minimum standard. States and treatment programs may choose a more stringent standard, e.g., 

require longer time periods of stability or provide fewer total take-home doses. In addition, it is 

important to recognize that simply because an individual patient meets the time-in-treatment 

criteria for take-home doses according to the schedule, the patient is not automatically eligible to 

receive those take-home medications. The decision as to whether or not an individual patient 

should receive take-home medication is a medical decision that is made by the medical director 

(physician) of the program. The physician must assess each patient’s progress and determine 

whether the rehabilitative benefit derived from decreasing the frequency of attendance outweighs 

any potential risks. While programs are being encouraged to individualize treatment and utilize 

the SAMHSA take-home schedule, this does not mean that they are required to do so. 

Exception Request for Variation from Detoxification Standards 

42 CFR § 8.12 specifies that a program may not admit a patient for more than two detoxification 

treatment episodes in one year. Patients with two or more unsuccessful detoxification episodes 

within a 12-month period must be assessed by the OTP physician for other forms of treatment. 

If, after this assessment, a physician believes it would be in the best interest of an individual 

patient to receive a third (or greater) detoxification treatment episode in one year, approval of an 

SMA-168 exception request by SAMHSA and (where applicable) the SOTA is required. On the 
FEDERAL OPIOID TREATMENT STANDARDS 60

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SMA-168 submission, the physician must justify the reason for requesting more than two 

detoxification episodes per year and attest that the patient has been assessed for other forms of 

treatment.

Exception Request for Other Reasons 

Programs should submit an SMA-168 exception request for approval of any treatment that 

differs from the federal opioid treatment standards set forth under 42 CFR § 8.12(i)(3). 

Programs do not need to submit SMA-168 exception requests to SAMHSA for the provision of 

care that is in compliance with the treatment standards set forth in Regulation 42 CFR § 8.12. 

For example, a common misperception is that a program must obtain approval from SAMHSA 

when treating a patient with methadone at doses greater than 100mg. Because 42 CFR § 8.12

places no such limit on the maximal allowed dose of methadone for a patient in treatment, no 

SMA-168 exception request is required by SAMHSA in this case. State rules, however, may 

differ. 

42 CFR § 8.12 does specify a limit of 30 mg of methadone for the initial dose and 40 mg for the 

total daily dose for new a patient on the first day of treatment. Thus, treatment on the first day 

with methadone doses greater than these amounts would require SAMHSA to approve an SMA168 form along with approval from the SOTA, where applicable. 

When in doubt, submit. If a program has consulted the text of the federal opioid treatment 

standards in 42 CFR § 8.12 and is unsure if the care it intends to provide for a patient is in 

compliance with the standards, the program should submit an SMA-168 exception request. 

There are no penalties for submitting an exception request when one is not required. Failure to 

submit and obtain approval from SAMHSA (and the SOTA where applicable) prior to providing 

care that deviates from the federal opioid treatment standards constitutes a serious regulatory 

violation, which may threaten a program's federal certification.

Submit an SMA-168 Exception Request 

SMA-168 exception requests can be submitted on-line from the SAMHSA OTP Exception 

Request Web site at http://otp-extranet.samhsa.gov. Assistance with on-line exception requests

and requests for a physician account on the OTP Exception Request Web site can be obtained by 

calling the SAMHSA OTP Exception Request Information Center at 1-866-OTP-CSAT (1-866-

687-2728) or by sending an email to otp-extranet@opioid.samhsa.gov. 
APPENDIX A. REFERENCES 61

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APPENDIX A. REFERENCES

American Society of Addiction Medicine. (2013) Drug Testing: A White Paper of the American 

Society of Medicine. Chevy Chase, MD: American Society of Addiction Medicine. 

American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental 

Disorders 5th ed., Arlington, VA: American Psychiatric Association. 

Baxter L.E. Sr, Campbell A., Deshields M., Levounis P., Martin J.A., McNicholas L., Payte J.T., 

Salsitz E.A., Taylor T, Wilford B.B. Safe methadone induction and stabilization: Report of an 

expert panel. J Addict Med. 2013 Nov-Dec; 7(6), 377–386. 

Center for Substance Abuse Treatment. (2005). Medication-Assisted Treatment for Opioid 

Addiction in Opioid Treatment Programs. Treatment Improvement Protocol (TIP) Series 43. 

(DHHS Publication No. SMA 05-4048). Rockville, MD: Substance Abuse and Mental Health 

Services Administration.

Center for Substance Abuse Treatment. (2004). Clinical Guidelines for the Use of 

Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) 

Series 40. (DHHS Publication No. SMA 04-3939) Rockville, MD: Substance Abuse and Mental 

Health Services Administration.

French, M. T., & Zarkin, G. A. (1992). The effects of drug abuse treatment on legal and illegal 

earnings. Contemporary Policy Issues, 10(2), 98–110. 

French, M. T., Zarkin, G. A., Hubbard, R. L., & Rachal, J. V. (1993). The effects of time in 

drug abuse treatment and employment on posttreatment drug use and criminal activity. 

American Journal of Drug and Alcohol Abuse, 19(1), 19–33. 

Gerstein, D. R., Johnson, R. A., Harwood, H. J., Fountain, D., Suter, N., & Malloy, K. (1994). 

Evaluating Recovery ervices: The California Drug and Alcohol Treatment Assessment 

(CALDATA). Sacramento, CA: California Department of Alcohol and Drug Programs. 

Hubbard, R. L., Marsden, M. E., Rachal, J. V., & Cavanaugh, E. R. (1989). Drug abuse 

treatment: A national study of effectiveness. Chapel Hill, NC: The University of North Carolina 

Press.

Institute of Medicine. (1990). Broadening the Base of Treatment for Alcohol Problems. 

Washington, DC: National Academy Press.

Institute of Medicine. (1995). Federal Regulation of Methadone Treatment. Washington, DC: 

National Academy Press.

Institute of Medicine. (1996) Telemedicine: A Guide to Assessing Telecommunications for 

Health Care. Washington, DC: The National Academies Press.
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Simpson, D. D., Joe, G. W., Lehman, W. E. K., & Sells, S. B. (1986). Addiction Careers: 

Etiology, Treatment, and 12-Year Follow-Up Outcomes. Journal of Drug Issues, 16(1), 107–

121. 

U.S. Government Printing Office. (2006). Code of Federal Regulations. Washington, DC: GPO. 
APPENDIX B. GUIDELINES PANEL 63

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APPENDIX B. GUIDELINES PANEL

On January 25, 2012, SAMHSA convened a panel of experts in Linthicum, MD, to review and 

begin to revise the 2007 Guidelines for the Accreditation of Opioid Treatment Programs. 

The key objectives of the meeting were to:

• Share information and data about the current state of the field of opioid treatment. 

• Discuss the impact of state regulations and oversight, private-for-profit programs, and multistate providers on the opioid treatment field. 

• Determine how buprenorphine and office-based treatment are impacting opioid treatment 

services.

• Identify factors that will increase the accountability, capacity, and effectiveness of opioid 

treatment services in specific settings or populations.

• Recommend revisions and updates to the guidelines that will improve the overall 

accountability, capacity, and effectiveness of opioid treatment service delivery.

Within the context of the 2007 Guidelines, the expert panel members were asked to consider the 

following 17 emerging topics: 

1. Approaches to address the use of benzodiazepines and/or alcohol in opioid treatment 

programs 

2. Electronic health records and opioid treatment programs 

3. Treatment in rural areas and the use of telemedicine in medication-assisted treatment

4. Interface between opioid treatment programs and state prescription drug monitoring 

programs 

5. Best practices when addressing medical and psychiatric disorders

6. Pain management in medication-assisted treatment

7. Methods for working with younger patients with prescription opioid addiction 

8. New treatments (e.g., extended release injectable naltrexone and new buprenorphine 

formulations)

9. Medication-assisted treatment and home health models of care

10. Strategies for integrating tobacco cessation

11. Pregnancy and post-partum care of women maintained on methadone/buprenorphine 

12. Expanded admission practices and emergency procedures

13. Use of authorized healthcare professionals 

14. Recovery

15. Standing orders 

16. Cardiac assessment

17. Hepatitis

Other topics added by attendees included: 

1. Methadone-related deaths

2. Medical marijuana

3. Take-home doses and drug charges 
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4. Homelessness/unemployment/patients on supplemental security income and social security 

disability insurance 

5. Standards to help coordinate care between a methadone patient and residential treatment

6. Medical director qualifications

The participants were divided into small workgroups to discuss and provide feedback on each 

topic. Comments were collected, inserted into the 2007 guidelines, and distributed to the panel. 

Subsequently, the document was reviewed and revised during multiple 2-hour conference calls. 

Accreditation Guidelines Expert Panel January 25, 2012

Clifford Bersamira

AOD Research Analyst

National Association of State Alcohol and 

 Drug Abuse Directors, Inc. 

Melinda Campopiano 

Medical Director

Narcotic Addiction Treatment Program

Western Psychiatric Institute and Clinic

Lynn Gerard

Director of Policy

Quality Improvement Coordinator 

BAART Programs

Belinda Greenfield

State Opioid Treatment Authority

Methadone Planning and Policy 

New York State Office of Alcoholism and

 Substance Abuse Services

John Hamilton 

Chief Executive Officer 

Recovery Network of Program 

Bettye Harrison 

Account Manager 

CARF International

Thomas R . (Ron) Jackson

Executive Director

Evergreen Treatment Services

Hilary Jacobs

Deputy Director, SOTA

Bureau of Substance Abuse Services 

MA Department of Public Health

Kurt Kemmling

Director and Founder 

Connecticut Chapter of NAMA 

Megan Marx

Associate Director, Special Contracts

Joint Commission

Candace McDaniel

Medical Director

Anti-Aging and Longevity Center of Texas, 

 P.A 

Shirley Becket Mikell

Director of Certification and Education 

NAADAC

Christine Ramirez

State Opioid Treatment Authority

Texas Department State Health Services

Marcia Trick

AOD Research Analyst, SOTA Coordinator 

National Association of State Alcohol and 

 Drug Abuse Directors, Inc.

Richard Weisskopf 

State Opioid Treatment Authority 

Illinois Department of Human Services
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APPENDIX C. FREQUENTLY ASKED QUESTIONS

COMMUNICATION WITH SAMHSA

What is the preferred method of submitting paperwork to SAMHSA?

SAMHSA prefers paperless communication. In light of this, SAMHSA has online versions of 

the SMA-162 and SMA-168 forms available for electronic submission and provides certified 

OTPs with access to the SAMHSA OTP Extranet, located at http://otp-extranet.samhsa.gov. 

To begin using the online system, request the appropriate account at http://otpextranet.samhsa.gov/request/. 

Existing OTPs may submit the SMA-168 form (exception requests) as well as personnel change 

and renewal requests via SAMHSA’s OTP Extranet located at http://otp-extranet.samhsa.gov. 

Requests for help with the Extranet should be emailed to the OTP Extranet Information Center at 

otp-extranet@opioid.samhsa.gov, or OTPs can call 1-866-OTP-CSAT between 8:30 and 5:00 pm 

EST, Monday through Friday. 

How does a new OTP request provisional certification and obtain a number from 

SAMHSA?

OTPs should use the online SMA-162 form located at 

http://dpt2.samhsa.gov/sma162/sma162.aspx to apply for provisional certification and notify 

SAMHSA of program changes. 

The OTP accesses, fills out, and electronically submits the online SMA-162 found on 

http://dpt2.samhsa.gov/sma162/sma162.aspx to SAMHSA. The Provisional Certification box on 

the SMA-162 form should be checked. SAMHSA will carefully review the form and application 

packet for completeness and notify the OTP of the need for additional information or 

clarification. Incomplete, inadequate, or poor quality applications will require a longer time to 

process. Applicants are urged to adhere closely to the instructions provided on the SAMHSA 

Web site, particularly, the checklist for documents to be submitted with the SMA-162. 

Electronic submission of all parts of the application will expedite evaluation of the application. 

After both the state where the OTP is located and the DEA complete their OTP approval process, 

SAMHSA will finalize its review and, upon approval of the program, assign the OTP a 

certification number.

What does an existing OTP do to find out its SAMHSA certification number? 

An existing OTP can find out its SAMHSA number by emailing the OTP Extranet Information 

Center at otp-extranet@opioid.samhsa.gov, by calling 1–866-OTP-CSAT, or by contacting the 

SAMHSA compliance officer for the state where the program is located. To identify the correct 
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compliance officer and find his or her contact information, access 

http://www.dpt.samhsa.gov/regulations/certification.aspx. 

How does an OTP inform SAMHSA of program changes? 

Existing OTPs should log in via the extranet (http://otp-extranet.samhsa.gov) and complete either 

the SMA-168 form (exception requests) or the SMA-162, which is used to notify SAMHSA of 

personnel changes and renewal requests. If the change at the program does not correspond to 

those provided on the form, an explanation should be attached. Or, the program may send a 

letter to the appropriate compliance officer informing SAMHSA of the change. The compliance 

officer’s contact information is found at 

http://www.dpt.samhsa.gov/regulations/certification.aspx. 

If I have a problem enrolling or getting on the extranet what should I do? 

Requests for help with the Extranet should be emailed to the OTP Extranet Information Center at 

otp-extranet@opioid.samhsa.gov, or OTPs can call 1-866-OTP-CSAT between 8:30 am - 5:00 

pm EST, Monday through Friday. 

Does an existing medication unit have to submit an SMA-162 separately from the original 

OTP when renewing its program’s SAMHSA certification or recertification?

No, SAMHSA requires only a single submission. Medication units are defined under federal

regulations as facilities, including community pharmacies that dispense treatment medications 

under the auspices of an existing OTP. The SAMHSA-certified OTP assumes all responsibilities 

for medication units. If the OTP has an existing medication unit and the OTP is filing an SMA162 with a program update, then the program needs to submit only one form with the appropriate 

attachments. One of the attachments always will be a description of the medication unit along

with the DEA registration number assigned to that medication unit. The medication unit’s DEA 

number will be different from the DEA number for the original OTP. For instructions on how to 

open a new medication unit, see the next question. 

How does an OTP apply to open a new medication unit?

Submit an SMA-162 with all requested attachments and signed documents to SAMHSA; this can 

be done online using SAMHSA’s Extranet at http://otp-extranet.samhsa.gov. In Item 14 of the 

application, “Purpose of Application,” check off “Medication Unit.” SAMHSA will process the 

form and forward it for approval to the DEA, which will arrange an inspection. The program 

also should submit all required materials to the SOTA to seek state approval, as appropriate. 

Once the DEA approves the medication unit, it will assign a new DEA registration number for 

that medication unit. The SAMHSA-assigned number will stay the same for both the original 

site and the medication unit(s). The required documents are:

• A description of how the medication unit receives the medication supply from the primary 
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facility.

• An affirmative statement that the medication unit is limited to administering and dispensing 

the narcotic treatment drug and collecting samples for drug testing or analysis.

• An affirmative statement that the sponsor agrees to retain responsibility for patient care.

• A diagram and description of the facilities to be used as a medication unit. 

• Total number of patients to be served by the primary facility and medication unit. 

• Total number of patients that will be served only at the medication unit. 

• A justification for need to establishing a medication unit. 

• Are there any other active medication units attached to this primary facility? If yes, please 

provide the name of the medication unit(s) and address. 

Does “Program Sponsor” on the SMA-162 refer to a program or a person?

A Program Sponsor should always be a person’s name, not the name of a program. The sponsor 

is the person who is legally responsible for the OTP and serves as the formal contact between 

SAMHSA and the OTP.

How much notice does an OTP have to give when informing SAMHSA of a program 

change? 

Within 3 weeks of a program change (e.g., medical director or program sponsor), an OTP should 

fill out the appropriate sections of the online SMA-162 and submit it to SAMHSA. 

What are the differences between accreditation, provisional certification, and certification?

Accreditation is defined by 42 CFR § 8.2 as the process of review and acceptance by an 

accreditation body. An accreditation body is an independent, not-for-profit organization or state 

governmental entity that has been approved by SAMHSA under 42 CFR § 8.3 to accredit OTPs 

that use opioid agonist treatment medications. An OTP must receive accreditation before it may 

be certified by SAMHSA.

Provisional Certification is a temporary certification granted for up to 1 year for a new OTP 

until it becomes accredited. SAMHSA may grant provisional certification to an OTP that has 

applied for accreditation and satisfies all of the requirements of SAMHSA’s application process. 

Provisional certification is granted to OTPs that have submitted form SMA-162 along with a 

statement identifying the accreditation body to which the OTP has applied, 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 may be granted for 1 year, unless SAMHSA determines that patient 

health would be adversely affected by the granting of provisional certification. 

Certification is the process by which SAMHSA determines that an OTP is qualified to provide 

opioid treatment under the federal opioid treatment standards. To become certified by 
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SAMHSA, OTPs must successfully complete the accreditation process and meet other 

requirements enumerated in regulation 42 CFR § 8.12. 

When a new OTP is just getting started, how much time does it have to become accredited?

OTPs have up to 1 year to become accredited. New OTPs must apply for accreditation with a 

SAMHSA-approved accreditation body and request provisional certification from SAMHSA by 

filling out and electronically submitting the online SMA-162 as part of the process for receiving 

SAMHSA certification. Information an OTP provides on the online SMA-162 should include a 

statement identifying the accreditation body to which the OTP has applied, 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 as 

well as all the other application requirements. A provisional certification will be granted for up 

to 1 year, unless SAMHSA determines that patient health would be adversely affected by the 

granting of provisional certification. The program must achieve accreditation within that same 

year.
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TAKE-HOME PRIVILEGES

How does an OTP request an exception to take-home requirements from SAMSHA?

To request an exception to any of the take-home related regulations, an OTP physician must 

login to SAMHSA’s extranet with his or her account and complete the SMA-168 online. For 

detailed instruction, please go to: http://www.dpt.samhsa.gov/regulations/exrequests.aspx. 

The regulations regarding take-home privileges indicate that a patient may have an extra 

take-home dose for the day that the clinic is closed. Can a patient’s weekly take-home 

include days adjacent to the day the clinic is closed? 

Sometimes a patient’s weekly take-home may include days adjacent to the day the clinic is 

closed; however, an OTP may not give this privilege to all patients in a clinic. This practice may 

be justified for an individual patient on occasion. By granting take-home privileges, the program 

is acknowledging that the eight criteria in the regulations for take-home medication have been 

reviewed. The take-home schedule must be tailored to each patient. Programs should consider 

patient risk for relapse and diversion when making take-home decisions. 

Our program is considering dispensing tablets for patients who have take-home privileges. 

Is this a diversion risk?

All opioid treatment medications pose a risk of diversion. The medical director must determine 

that a patient is responsible enough to receive solid take-home medication. Diskettes formulated 

to reduce the potential for intravenous administration pose less diversion risk than tablets. 

The regulations state that a person on short-term detoxification cannot have take-home 

medications. How does this apply to the programs that want to close on a holiday or a 

Sunday?

An exemption request is needed to dispense take-home doses to short-term detoxification 

patients for holidays and days when the program is closed. SAMHSA will consider annual 

program-wide exemption requests for short-term detoxification patients, although the exemption 

should not be applied universally. The exemption permits only those patients deemed stable 

enough to safely take the medication unsupervised and who present a minimal risk for diversion 

to be granted a take-home dose in this situation. With a program-wide exemption in place, the 

program may provide a take-home for such patients without requesting an individual exemption 

for each one on each occasion. 

If a patient is in a comprehensive maintenance program, is on take-home status, and 

requests a medically supervised withdrawal, can he/she remain on take-homes during the 

withdrawal period?

Yes, because the patient was admitted to maintenance treatment, take-homes would be permitted. 
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A few states and OTPs have recognized that the medication take-home schedule outlined 

under 42 CFR § 8.12(i) is different from schedules outlined in some state regulations. 

Which take-home schedule takes precedence?

Programs should adhere to the take-home schedule that is the most restrictive. Exemption 

requests should be submitted to SAMHSA or the state if there is a need to deviate from either of 

the schedules. 
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DETOXIFICATION PROGRAMS

Is a detoxification program considered to be an OTP?

Yes, a detoxification program is considered to be an OTP. 42 CFR § 8.12 defines an OTP as a 

“program or practitioner engaged in opioid treatment of individuals with an opioid agonist 

treatment medication.” 42 CFR § 8.11(a)(1) states that an OTP must have a current, valid 

certification from SAMHSA to be considered qualified by the Secretary of DHHS to dispense 

methadone or buprenorphine for the treatment of addiction. A unit of a hospital that intends to 

offer new detoxification services using methadone or buprenorphine should apply to SAMHSA 

for provisional certification.

Will SAMHSA require inpatient detoxification programs that use methadone to be 

accredited and certified? As a freestanding detoxification/rehabilitation facility dispensing 

methadone for detoxification only, will we be held to these accreditation/certification 

standards?

Yes, SAMHSA requires inpatient detoxification programs that use methadone to be accredited 

and certified. 42 CFR § 8.12 addresses all forms of opioid treatment, including maintenance and 

detoxification treatment.

Will the accreditation and certification processes differ in any way from what is being 

required of maintenance programs?

No, detoxification programs are subject to the same standards as maintenance programs. 

Standards are detailed in 42 CFR § 8.12. OTPs providing inpatient detoxification services must 

be accredited and certified. Accreditation bodies may develop specific detoxification treatment 

accreditation standards and processes for surveying OTPs providing such services. 

The regulations state that, in order to have take-home medications, a person has to be in a 

comprehensive maintenance program, but long-term detoxification is not addressed.

No medications shall be dispensed to patients in short-term detoxification treatment or interim 

maintenance treatment for unsupervised or take-home use (42 CFR § 8.12(i)(4)). 
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TREATMENT

42 CFR § 8.12(f)(2), initial medical examination services, states that the initial exam should 

take place before admission or within the first 14 days. Can the patient begin treatment 

immediately on admission and see the physician or authorized healthcare professional, as 

appropriate, any time within that 14-day period, or must he/she see the physician or 

authorized healthcare professional, as appropriate, before treatment commences?

42 CFR § 8.12(f)(2) addresses this question as follows: OTPs shall require each patient to 

undergo a complete, fully documented physical examination by or under the supervision of a 

physician or authorized healthcare professional, as appropriate, before admission to the OTP. 

The full medical examination, including the results of serology and other tests, must be 

completed within 14 days following admission. 

When a person in treatment for opioid addiction is abstinent from illicit opioids but tests 

positive for another drug, can we keep him or her in treatment?

Yes, a person who tests positive for drugs other than opioids may be kept in treatment. SAMHA 

encourages OTPs to ensure that the abuse of drugs other than opioids is addressed in treatment. 

The OTP should provide appropriate counseling and other treatment if it identifies abuse of other 

drugs or alcohol as a problem. When necessary, the OTP may refer the patient to another 

program for additional treatment services. For further information, please refer to TIP 43. 

The SAMHSA regulations do not state the drugs for which patients should be tested. How 

do we determine which drugs to test?

The regulations require that OTPs perform adequate testing services at minimum intervals. 

SAMHSA guidelines recommend that drug-screening tests should include tests for opioids, 

methadone, amphetamines, cocaine, and benzodiazepines. Testing for other drug use should be 

determined by community drug use patterns or individual medical indications. Accreditation 

bodies may adopt a more flexible standard, which would allow the OTP to forgo testing for 

drugs that are not commonly used in that particular community or population. The accreditation 

bodies may offer additional guidance on this subject. 

What happens when drug testing reveals use of specific drugs such as amphetamines and 

barbiturates?

The OTP should provide appropriate counseling and other treatment if abuse of other drugs is 

identified as a problem. When necessary, the OTP should coordinate with treatment programs 

offering higher levels of care to address the individual’s polysubstance use. 
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FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

Scenario: Within a few days of discharge, a client feels as though she wants to use again. 

She calls the OTP from which she was discharged to request continued treatment. What 

needs to be in place before she can be readmitted? Does she have to have used again?

The patient does not have to use drugs again to be admitted. He/she may be readmitted after the 

physician or authorized healthcare professional, as appropriate, examines him or her and writes 

an admission order. 
APPENDIX C. FREQUENTLY ASKED QUESTIONS. 74

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MEDICATION

Some pain management clinics are dispensing methadone. How can an OTP tell whether a 

person is legally medicated or using illicit drugs?

Although there is no foolproof way to determine whether a person is legally medicated or using 

illicit drugs, a patient should be asked to sign a release of information to allow the pain 

management clinic to verify to the OTP that he/she is receiving opioid analgesics. Prescription 

drug monitoring programs (PDMPs), where available, will be helpful in this area.

What can we do about the dose cap restriction?

The Federal Guidelines for Opioid Treatment Programs advises against dosage caps. Medical 

evidence does not support their use. For additional information, access TIP 43

(http://www.ncbi.nlm.nih.gov/books/NBK64164/pdf/TOC.pdf). Educating OTP physicians and 

staff appears to be the best approach for encouraging individualized treatment without dosage 

cap restrictions.

What is meant by the statement, “Methadone should be dispensed only in oral form and 

shall be formulated in such a way as to reduce its potential for parenteral abuse” (42 CFR 

§ 8.12(h)(3)(i))?

Only oral forms of methadone should be dispensed. Parenteral and non-oral forms are prohibited 

in opioid addiction treatment. Previous regulations restricted dispensing methadone for 

addiction treatment to liquid only; however, the current regulations removed the liquid-only 

restriction and now permit solid forms of the medication. Diskettes and tablets are formulated to 

conform to standards and are acceptable forms of methadone for use in OTPs. Diskettes 

formulated to reduce the potential for intravenous administration pose less risk of diversion than 

tablets.

What is the federal regulation regarding the initial opioid medication dose? 

The regulation is 42 CFR § 8.12 (h)(3)(ii)), and it states that “For each new patient enrolled in a 

program, the initial dose of methadone shall not exceed 30 mg and the total dose for the first day 

shall not exceed 40 mg, unless the program physician documents in the patient’s record that 40

mg did not suppress opiate abstinence symptoms.” 
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DRUG TESTING

Our OTP is exploring the use of oral solution testing. Can an OTP use alternatives to urine 

specimen testing to fulfill the drug testing requirements under the federal opioid treatment 

regulations? 

The federal regulations do not specify urine as the only type of biological sample that can be 

tested. Instead, 42 CFR § 8.12 (f)(6) says: “OTPs must provide adequate testing or analysis for 

drugs of abuse, including at least eight random drug abuse tests per year, per patient in 

maintenance treatment, in accordance with generally accepted clinical practices.” A CSAT letter 

to the field dated July 18, 2003, stated that offsite drug testing using oral fluids may be adequate, 

at least in some populations. It is SAMHSA’s view that sufficient information is now available 

for medical directors to make a determination of the adequacy of oral fluid testing in the OTP 

setting.

Drug testing is considered a medical service and an important component of treatment. Test 

results are used to determine whether dosing adjustments or other treatment interventions are 

needed. In addition, drug test results are important in determining whether a patient is stable 

enough to receive medications for unsupervised use. Accordingly, the OTP medical director 

remains responsible for the adequacy of drug abuse testing services and all other medical 

services provided by the program. Whatever drug abuse test the OTP uses as a part of the 

accreditation survey, the OTP must be able to support the use of the test with documented 

evidence showing that the test is adequate.

SAMHSA expects that accreditation bodies will review these Guidelines and adopt all or part for 

inclusion in the accreditation standards they apply to OTPs. States may, however, adopt specific 

language regarding the type of biological specimen acceptable for testing. As always, OTPs 

should be careful to comply with any regulations imposed by the state that exceed the federal

standards. 
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APPENDIX D. SAMPLES OF STANDARD FORMS

EXAMPLE OF STANDARD CONSENT TO OPIOID MAINTENANCE TREATMENT

CONSENT TO PARTICIPATION IN OPIOID PHARMACOTHERAPY TREATMENT 

Patient’s Name: Date: 

I hereby authorize and give voluntary consent to the Division and its medical personnel to dispense and 

administer opioid pharmacotherapy (including methadone or buprenorphine) as part of the treatment of 

my addiction to opioid drugs. Treatment procedures have been explained to me, and I understand that 

this will involve my taking the prescribed opioid drug at the schedule determined by the program 

physician, or his/her designee, in accordance with federal and state regulations.

It has been explained that, like all other prescription medications, opioid treatment medications can be 

harmful if not taken as prescribed. I further understand that opioid treatment medications produce 

dependence and, like most other medications, may produce side effects. Possible side effects, as well as 

alternative treatments and their risks and benefits, have been explained to me.

I understand that it is important for me to inform any medical provider who may treat me for any medical 

problem that I am enrolled in an opioid treatment program so that the provider is aware of all the 

medications I am taking, can provide the best possible care, and can avoid prescribing medications that 

might affect my opioid pharmacotherapy or my chances of successful recovery from addiction.

I understand that I may withdraw voluntarily from this treatment program and discontinue the use of the 

medications prescribed at any time. Should I choose this option, I understand I will be offered medically 

supervised withdrawal. 

For Female Patients of Childbearing Age: There is no evidence that methadone pharmacotherapy is 

harmful during pregnancy. If I am or become pregnant, I understand that I should tell my medical 

provider right away so that I can receive appropriate care and referrals. I understand that there are ways 

to maximize the healthy course of my pregnancy while I am in opioid pharmacotherapy. 

Signature of Patient Date of Birth Date

Witness: 

Adapted with permission from Department of Psychiatry and Behavioral Sciences, Albert Einstein 

College of Medicine, Division of Substance Abuse, Bronx, NY. 
APPENDIX D. SAMPLES OF STANDARD FORMS 77

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EXAMPLE OF MEDICATION CHAIN-OF-CUSTODY RECORD

Date: 

Name of Treatment Program: __________________________________________________ 

Name of Treatment Program Dispensing Nurse:

Medication To Be Delivered (Methadone/Buprenorphine/Buprenorphine +Naloxone):

 ________________________ 

Number of Doses To Be Delivered:

Medication Provided From ________________________ to ________________________

 (Date) (Date)

Name of Person Transporting Medication: ________________________________________

License Number of Person Transporting Medication: _______________________________

Date Medication Received: __________________ Number of Doses Received___________ 

Medication Received Covering_____________________ to ________________________

 (Date) (Date)

COMMENTS: _______________________________________________________________

Signature of person receiving medication Signature of person transporting medication

Date of Administration and Initials of Patient Receiving Medication

DATE Pt. Initials DATE 

Pt. Initials
APPENDIX E: PROGRAM RESPONSIBILITIES 78

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

APPENDIX E. PROGRAM RESPONSIBILITIES

Programs should develop and implement policies and procedures to promote and protect 

patients’ rights as well as their health and well-being. Both the OTP’s responsibilities and 

patient rights should be posted at the treatment site and reviewed with the patient following 

admission, at the end of the stabilization period, and when changes occur. For patients unable to 

read, program staff should verbally explain the patient’s rights and the program’s rules and 

regulations and document this interaction. In addition, programs should have accommodations 

in place for patients who do not speak English. 

Program responsibilities include:

• Provide treatment that is fair and impartial, regardless of race, sex, age, and source of payment, 

and convey a sense of dignity and trust to the patient. 

• Provide treatment according to accepted clinical practice and community standards of care.

• Ensure patients receive full disclosure of information about treatment and medication. 

• Inform patients about potential interactions with and adverse reactions to other substances, 

including alcohol, other prescribed or OTC pharmacological agents, food, and medical 

procedures. 

• Inform patients about the financial aspects of treatment, including the consequences of 

nonpayment of required fees. An OTP should establish payment expectations and work with the 

patient on following agreed-upon procedures to ensure payment for services rendered is 

received. Also, processes that help patients resolve financial difficulties that might occur over 

the course of treatment should be explained. 

• Advise patients of their right to give informed consent before becoming involved in research 

projects and to retain a copy of the informed consent form. 

• Provide an adequate number of competent, qualified, and experienced professional clinical staff 

to implement and supervise the treatment plan, consistent with patient needs.

• Inform patient about alternative medications, treatment alternatives, alternative modalities, and 

scientific advances affecting treatment.

• Protect patients, staff, and the public from another patient who acts in a manner that disrupts the 

safety of the clinic environment. Programs, however, also have a responsibility to attempt to 

determine the cause of the patient’s behavior so an appropriate referral may be made to an 

alternative method of care.

• Do not deny treatment and services to patients who refuse to participate in research activities.
APPENDIX E: PROGRAM RESPONSIBILITIES 79

FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS

• Develop and display patient grievance policies and procedures that specify the minimum 

elements of due process applicable to the program setting and resources used to prevent, 

investigate, and resolve patient complaints. Program administration should obtains and be 

responsive to patients’ feedback concerning their care. 

• Establish procedures to provide medication to traveling patients and consider providing takehome medication. At times, when patients must transfer to a different level of care or location, it 

may be appropriate for the program to provide sufficient medication for the patient until arrival 

at the new location. Under these circumstances, a record of the chain of custody for transporting 

methadone to the new program may be required. Please see Appendix D. Samples of Standard 

Forms for an example of the chain-of-custody form. 

• Accommodate the patient’s desire to remain in opioid therapy at an alternative program before 

the patient is discharged. 

• Obtain patient consent before changing the patient’s dose of opioids or other medications unless 

the patient signs a document waiving such consent. 
SMA # PEP15-FEDGUIDEOTP

First Printed 2015