Definitions relating to OTPs

20 – Definitions relating to OTPs (Rev. 13147; Issued: 03-28-25; Effective: 01-01-25; Implementation: 03-25-25) A. Episode of care Episode of care means a one-week (contiguous 7-day) period. B. Opioid treatment program (OTP) OTP means an entity that is an opioid treatment program (as defined in 42 CFR 8.2, or any successor regulation) that meets the requirements described in Section 30 - Requirements for OTPs. C. Opioid use disorder (OUD) treatment service OUD treatment service means one of the following items or services for the treatment of opioid use disorder that is furnished by an opioid treatment program that meets the requirements described in Section 30 - Requirements for OTPs. 1. Opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by the Food and Drug Administration (FDA) under section 505 of the Federal, Food, Drug, and Cosmetic Act (FFDCA) for use in treatment of opioid use disorder. There are three drugs currently approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone, and naltrexone.0F1 2. Dispensing and administration of opioid agonist and antagonist treatment medications, if applicable. 3. Substance use counseling by a professional to the extent authorized under State law to furnish such services including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. 4. Individual and group therapy with a physician or psychologist (or other mental health professional to the extent authorized under State law), including services furnished via two-way interactive audio- video communication technology, as clinically appropriate, and in compliance with all applicable requirements. 1 https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm. During the Public Health Emergency (PHE) for the COVID-19 pandemic, as well as after the conclusion of the PHE, therapy and counseling may be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology if two-way audio/video communications technology is not available to the beneficiary, provided all other applicable requirements are met, including circumstances in which the beneficiary is not capable of or does not consent to the use of devices that permit a two-way audio/video interaction. 5. Toxicology testing. 6. Intake activities, including initial medical examination services required under 42 CFR 8.12(f)(2) and initial assessment services required under 42 CFR 8.12(f)(4). 7. Periodic assessment services required under 42 CFR 8.12(f)(4) that are furnished during a face-to- face encounter, including, beginning on January 27, 2020, services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. The flexibility to furnish these services using two-way interactive audio-video communication technology was originally limited to services furnished during the PHE as defined in 42 CFR 400.200, but was subsequently made permanent effective beginning on January 1, 2021. Beginning January 1, 2025, in cases where a beneficiary does not have access to two-way audio-video communications technology, periodic assessments can be furnished using audio-only telephone calls if all other applicable requirements are met. 8. Beginning January 1, 2021, opioid antagonist medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for the emergency treatment of known or suspected opioid overdose and overdose education furnished in conjunction with opioid antagonist medication. 9. Beginning on January 1, 2024, OTP intensive outpatient services, which means one or more services specified in § 410.44(a)(4) when furnished by an OTP as part of a distinct and organized intensive ambulatory treatment program for the treatment of OUD and that offers less than 24-hour daily care other than in an individual's home or in an inpatient or residential setting. OTP intensive outpatient services are reasonable and necessary for the diagnosis or active treatment of the individual's condition; are reasonably expected to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization; and are furnished in accordance with a physician or non-physician practitioner (as defined in section 1842(b)(18)(C) of the Act) certification and plan of care, as permitted by State law and scope of practice requirements, in which a physician or non- physician practitioner must certify that the individual has a need for a minimum of nine hours of services per week and requires a higher level of care intensity compared to other non-intensive outpatient OTP services. OTP intensive outpatient services do not include FDA-approved opioid agonist or antagonist medications for the treatment of OUD or opioid antagonist medications for the emergency treatment of known or suspected opioid overdose, or toxicology testing. 10. Coordinated care and/or referral services, provided by an OTP to link a beneficiary with community resources to address unmet health-related social needs or the need and interest for harm reduction interventions and recovery support services that significantly limit the ability to diagnose or treat a patient’s opioid use disorder. 11. Patient navigational services and/or peer recovery support services, when provided directly by an OTP or through referral, in order to assist patients with an OUD in navigating the health system and accessing supportive services, and/or to provide support in meeting patient-driven OUD treatment and recovery goals. D. OTP Mobile Units Beginning January 1, 2023, services furnished via OTP mobile units will be considered for purposes of determining payments to OTPs under the Medicare OTP bundled payment codes and/or add-on codes to the extent that the services are medically reasonable and necessary and are furnished in accordance with SAMHSA and DEA guidance. For purposes of the geographic adjustment, OUD treatment services furnished via an OTP mobile unit will be treated as if the services were furnished at the physical location of the OTP registered with DEA and certified by SAMHSA.