§ 8.2 - thnsp;8.2 Definitions.

§ §thnsp;8.2 Definitions.

The following definitions apply to this part:

Accreditation

body means a body

Body or “the Body” means an organization that has been approved by

SAMHSA

the Secretary in this part to accredit

opioid treatment programs using opioid agonist treatment medications

OTPs dispensing MOUD.

Accreditation

body

Body application means the application filed with

SAMHSA

the Secretary for purposes of obtaining approval as an

accreditation body. Accreditation body application means the application filed with SAMHSA for purposes of obtaining approval as an accreditation body

Accreditation Body, as described in § 8.3(b).

Accreditation elements mean the elements or standards that are developed and adopted by an accreditation body Accreditation Body and approved by SAMHSAthe Secretary.

Accreditation survey means an onsite or virtual review and evaluation of an opioid treatment program OTP by an accreditation body Accreditation Body for the purpose of determining compliance with the Federal opioid use disorder treatment standards described in § 8.12.

Accredited

opioid treatment program

OTP means an

opioid treatment program

OTP that is the subject of a current, valid accreditation from an

accreditation body

Accreditation Body approved by

SAMHSA

the Secretary under § 8.3(d).

Additional Credentialing means board certification in addiction medicine or addiction psychiatry by the American Board of Addiction Medicine, the American Board of Medical Specialties, or the American Osteopathic Association or certification by the American Board of Addiction Medicine, or the American Society of Addiction Medicine.

Approval term means the 3 year period in which a practitioner is approved to treat up to 275 patients that commences when a practitioner's Request for Patient Limit Increase is approved in accordance with § 8.625.

Behavioral health services means any non-pharmacological intervention carried out in a therapeutic context at an individual, family, or group level. Interventions may include structured, professionally administered clinical interventions (e.g., cognitive behavior therapy or insight-oriented psychotherapy) delivered in-person, interventions delivered or remotely via telehealth or telemedicine shown in clinical trials , which has been shown to facilitate medication-assisted treatment (MAT) outcomes, or non-professional interventions. clinical interventions.

Care plan means an individualized treatment and/or recovery plan that outlines attainable treatment goals that have been identified and agreed upon between the patient and the OTP clinical team, and which specifies the services to be provided, as well as the proposed frequency and schedule for their provision.

Certification means the process by which SAMHSA the Secretary determines that an opioid treatment program OTP is qualified to provide opioid OUD treatment under the Federal opioid Opioid Use Disorder treatment standards.

Certification application means the application filed by an opioid treatment program OTP for purposes of obtaining certification from SAMHSAthe Secretary, as described in § 8.11(b).

Certified opioid treatment program means an opioid treatment program OTP that is the subject of a current, valid certification under § 8.11.

Comprehensive

maintenance

treatment is

maintenance

treatment that includes the continued use of MOUD provided in conjunction with

a comprehensive

an individualized range of appropriate harm reduction, medical

and rehabilitative services.

Covered medications means the drugs or combinations of drugs that are covered under 21 U.S.C. 823(g)(2)(C).

Detoxification treatment means the dispensing of an opioid agonist treatment medication in decreasing doses to an individual to alleviate adverse physical or psychological effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a drug-free state within such period

, behavioral health, and recovery support services.

Conditional certification is a type of temporary certification granted to an OTP that has requested renewal of its certification and that has received temporary accreditation for one year by an approved Accreditation Body. The one-year accreditation period is to allow the OTP to address areas of significant non-conformance with accreditation standards that do not involve immediate, high-risk health and/or safety concerns.

Continuous medication treatment means the uninterrupted treatment for OUD involving the dispensing and administration of MOUD at stable dosage levels for a period in excess of 21 days.

Dispense means to deliver a controlled substance medication to an ultimate user by, or pursuant to, the lawful order of, a practitioner, including the prescribing and administering of a controlled substancemedication.

Diversion control plan means a set of documented procedures that reduce the possibility that controlled substances medications will be transferred or used illicitly.

Emergency situation means that an existing State, tribal, or local system for substance use disorder services is overwhelmed or unable to meet the existing need for medication-assisted treatment as a direct consequence of a clear precipitating event. This precipitating event must have an abrupt onset, such as practitioner incapacity; natural or human-caused disaster; an outbreak associated with drug use; and result in significant death, injury, exposure to life-threatening circumstances, hardship, suffering, loss of property, or loss of community infrastructure.

Federal opioid

otherwise shared with others to whom the medication was not prescribed or dispensed.

Federal Opioid Use Disorder treatment standards means the standards established by the Secretary in § 8.12 that are used to determine whether an

opioid treatment program

OTP is qualified to engage in

e opioid

OUD treatment. The Federal

opioid

Opioid Use Disorder treatment standards established in § 8.12 also include the standards established by the Secretary regarding the quantities of

opioid drugs

MOUD which may be provided for unsupervised, take-home use.

For-cause inspection means an inspection of an opioid treatment program , by the Secretary, or by an accreditation body, an Accreditation Body, or a State authority, of an OTP that may be operating in violation of Federal opioid Opioid Use Disorder treatment standards, may be providing substandard treatment, or may be serving as a possible source of diverted medications.

Interim maintenance treatment means maintenance treatment provided in an opioid treatment program in conjunction with appropriate medical services while a patient is awaiting transfer to a program that provides comprehensive maintenance treatment.

Long-term detoxification treatment means detoxification treatment for a period more than 30 days but not in excess of 180 days.

Maintenance treatment means the dispensing of an opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days in the treatment of an individual for opioid use disorder.

, or where patient well-being is at risk.

Harm reduction refers to practical and legal evidence-based strategies, including: overdose education; testing and intervention for infectious diseases, including counseling and risk mitigation activities forming part of a comprehensive, integrated approach to address human immunodeficiency virus (HIV), viral hepatitis, sexually transmitted infections, and bacterial and fungal infections; distribution of opioid overdose reversal medications; linkage to other public health services; and connecting those who have expressed interest in additional support to peer services.

Individualized dose means the dose of a medication for opioid use disorder, ordered by an OTP practitioner and dispensed to a patient, that sufficiently suppresses opioid withdrawal symptoms. Individualized doses may also include split doses of a medication for opioid use disorder, where such dosing regimens are indicated.

Interim treatment means that on a temporary basis, a patient may receive some services from an OTP, while awaiting access to more comprehensive treatment services. The duration of interim treatment is limited to 180 days.

Long-term care facilities mean those facilities that provide rehabilitative, restorative, and/or ongoing services to those in need of assistance with activities of daily living. Long-term care facilities include: extended acute care facilities; rehabilitation centers; skilled nursing facilities; permanent supportive housing; assisted living facilities; and chronic care hospitals.

Medical director means a physician, licensed to practice medicine in the jurisdiction in which the opioid treatment program OTP is located, who assumes responsibility for administering all medical and behavioral health services performed provided by the program, either by performing them directly or by delegating specific responsibility including their administration. A medical director may delegate specific responsibilities to authorized program physicians and healthcare professionals , appropriately licensed non-physician practitioners with prescriptive authority functioning under the medical director's direct supervision.

Medical and rehabilitative services means services such as medical evaluations, counseling, and rehabilitative and other social programs (e.g., vocational and educational guidance, employment placement), that are intended to help patients in opioid treatment programs become and/or remain productive members of society.

Medication-Assisted Treatment (MAT) means the use of medication in combination with behavioral health services to provide an individualized approach to the treatment of substance use disorder, including opioid use disorder.

Medication unit means a facility

supervision, or appropriately licensed and/or credentialed non-physician healthcare professionals providing services in the OTP, in compliance with applicable Federal and State laws. Such delegations will not eliminate the medical director's responsibility for all medical and behavioral health services provided by the OTP.

Medication for Opioid Use Disorder or MOUD means medications, including opioid agonist medications, approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), for use in the treatment of OUD. As used in this part, “continuous medication treatment” is intended to be synonymous with the term “maintenance” treatment as used in 21 U.S.C. 823(h)(1), and the term “withdrawal management” is intended to be synonymous with the term “detoxification” as used in 21 U.S.C. 823(h)(1).

Medication unit means an entity that is established as part of, but geographically separate from, an opioid treatment program OTP from which appropriately licensed private practitioners OTP practitioners, contractors working on behalf of the OTP, or community pharmacists may dispense or administer an opioid agonist treatment medication or MOUD, collect samples for drug testing or analysis, or provide other OTP services. Medication units can be a brick-and-mortar location or mobile unit.

Nationally recognized evidence-based guidelines means mean a document produced by a national or international medical professional association, public health agency, such as the World Health Organization, or governmental body with the aim of assuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions .

Opioid agonist treatment medication means any opioid agonist drug that is 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 use disorder.

Opioid dependence means repeated self-administration that usually results in opioid tolerance, withdrawal symptoms, and compulsive drug-taking. Dependence may occur with or without the physiological symptoms of tolerance and withdrawal.

Opioid drug means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

Opioid treatment program or “OTP” means a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication

for the management of OUD and other health conditions that are widely recognized within the United States.

Opioid Treatment Program or OTP means a program engaged in OUD treatment of individuals with MOUD registered under 21 U.S.C. 823(

g

h)(1).

Opioid

treatment program

Treatment Program certification means the process by which

SAMHSA

the Secretary determines that an

opioid treatment program

OTP applicant is qualified to provide

opioid

Opioid Use Disorder treatment under the Federal

opioid

Opioid Use Disorder treatment standards described in § 8.12.

Opioid

use disorder

Use Disorder means a cluster of cognitive, behavioral, and physiological symptoms

in which the individual continues use of opioids despite significant opioid-induced problems. Opioid use disorder

associated with a problematic pattern of opioid use that continues despite clinically significant impairment or distress within a 12-month period.

Opioid Use Disorder treatment means the dispensing of

an opioid agonist treatment medication

MOUD, along with the provision of a

comprehensive

range of medical and

rehabilitative

behavioral health services,

when

as clinically necessary and based on an individualized assessment and a mutually agreed-upon care plan, to an individual to alleviate the combination of adverse medical, psychological, or physical effects

incident to an opioid use disorder. This term includes a range of services including detoxification treatment, short-term detoxification treatment, long-term detoxification treatment, maintenance treatment, comprehensive maintenance treatment, and interim maintenance treatment. Patient for purposes of subparts B through E of

associated with an OUD.

Patient, for purposes of this part, means any individual who receives maintenance or detoxification treatment continuous treatment or withdrawal management in an opioid treatment program. For purposes of subpart F of this part, patient means any individual who is dispensed or prescribed covered medications by a practitioner.

Patient limit means the maximum number of individual patients that a practitioner may dispense or prescribe covered medications to at any one time.

Practitioner means a physician

OTP.

Physical and behavioral health services include services such as medical and psychiatric screening, assessments, evaluations, examinations, and interventions, counseling, health education, peer support services, and social services (e.g., vocational and educational guidance, employment training), that are intended to help patients receiving care in OTPs achieve and sustain remission and recovery.

Practitioner, for purposes of this part, means a health care professional who is appropriately licensed by the a State to prescribe and/or dispense covered medications and who possesses a waiver under 21 U.S.C. 823(g)(2).

Practitioner incapacity means the inability of a practitioner as a result of an involuntary event to physically or mentally perform the tasks and duties required to provide medication-assisted treatment in accordance with nationally recognized evidence-based guidelines

for opioid use disorders and, as a result, is authorized to practice within an OTP.

Program sponsor means the person named in the application for certification described in § 8.11(b) as responsible for the operation of the opioid treatment program OTP and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, rehabilitativebehavioral health, or counseling social services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall employ a ensure that an actively licensed physician for occupies the position of medical director .

Short-term detoxification treatment means detoxification treatment for a period not in excess of 30 days.

State Authority

within an OTP.

Recovery support services means:

(1) Recovery is the process of change through which people improve their health and wellness, live self-directed lives, and strive to reach their full potential.

(2) Recovery support services can include, but are not limited to, community-based recovery housing, peer recovery support services, social support, linkage to and coordination among allied service providers and a full range of human services that facilitate recovery and wellness contributing to an improved quality of life. The services extend the continuum of care by strengthening and complementing substance use disorder (SUD) treatment interventions in different settings and stages.

Split dosing means dispensing of a single dose of MOUD as separate portions to be taken within a 24-hour period. Split dosing is indicated among, but not limited to, those patients who: possess a genetic variant which increases methadone metabolism; concurrently take other medications or drink alcohol that also induce hepatic enzymes leading to more rapid metabolism of methadone; who are pregnant; or for whom methadone or buprenorphine are being used to treat a concurrent pain indication in addition to the diagnosis of OUD. This leads to more stable, steady-state medication levels.

State Opioid Treatment Authority (SOTA) is the agency designated by the Governor of a State, or other appropriate official designated by the Governor, to exercise the responsibility and authority within the State or Territory for governing the treatment of

opioid use disorder with an opioid drug.

Treatment plan means a plan that outlines for each patient attainable short-term treatment goals that are mutually acceptable to the patient and the opioid treatment program and which specifies the services to be provided and the frequency and schedule for their provision.

[66 FR 4090, Jan. 17, 2001, as amended at 81 FR 44736, July 8, 2016; 81 FR 62404, Sept. 9, 2016]

OUD with MOUD in OTPs.

Telehealth or telemedicine, for purposes of this part, is the delivery and facilitation of health and health-related services including medical care, counseling, practitioner, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies. This includes Health Insurance Portability and Accountability Act (HIPAA)-compliant video and audio-only communication platforms.

Withdrawal management means the dispensing of a MOUD in decreasing doses to an individual to alleviate adverse physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such period. Long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.