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Medicare Benefit Policy Manual  Chapter 17 - Opioid Treatment Programs (OTPs)   Table of Contents  (Rev. 12418, 12- 21-23)  Transmittals for Chapter 17    10  OTP General Information   20 - Definitions Relating to OTPs   30  Requirements for OTPs   40  Bundled payments for OUD treatment services    40.1.1 Aspects of the bundle    40.1.2 Duplicative Payments under Parts B or D    40.1.3 Cost Sharing  50 - Adjustments to Bundled Payment Rates for OUD Treatment Services    50.1 -  Locality Adjustment  50.2. -  Annual Update                    10  OTP General Information  (Rev. 268: Issued; 02- 14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  Section 2005 of the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act) (Pub. L. 115- 271, enacted October 24, 2018) added new sections 1861( jjj), 1861(s)(2)(HH), 1833(a)(1)(CC) and 1834(w)to the Social Security Act (the Act), establishing a new Part B benefit category for opioid use disorder ( OUD)  treatment services furnished by an opioid treatment program (OTP) beginning on or after January 1, 2020.    The statutory requirements for OUD treatment services furnished by an OTP can be found in section 1861(jjj) of the Act. Additionally, many of the regulations pertaining to OTPs can be found at 42 CFR 410.67.  For information on claims processing, see Pub 100- 04, Medicare Claims Processing Manual, Chapter 39.   20  Definitions relating to OTPs  (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24)  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.1   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. During the PHE, as defined in 42 CFR 400.200, and through the end of CY 2024, 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 re asonably 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 t he emergency treatment of known or suspected opioid overdose, or toxicology testing.  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.  30  Requirements for OTPs  (Rev. 268:  Issued; 02 -14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  To participate in the Medicare program and receive payment, an opioid treatment program must meet all of the following:   A. Be enrolled in the Medicare program.   An OTP must be enrolled in Medicare to receive Medicare payment for covered OUD treatment services under section 1861(jjj)(1) of the Act.    B. Have in effect a certification by the Substance Abuse and Mental Health Service Administration (SAMHSA) for the opioid treatment program.   OTPs must be certified by SAMHSA to furnish Medicare -covered OUD treatment services.  SAMHSA has created a system to certify and accredit OTPs, which is governed by 42 CFR part 8, subparts B and C.  To be certified by SAMHSA, OTPs must comply with the fede ral opioid treatment standards as outlined in  8.12, be accredited by a SAMHSA -approved accreditation body, and comply with any other conditions for certification established by SAMHSA.    C. Be accredited by an accrediting body approved by the SAMHSA.   OTPs must be accredited by a SAMHSA -approved accrediting body in order to furnish Medicare -covered OUD treatment services.  In 2001, the Department of Health and Human Services (HHS) and SAMHSA issued final regulations to establish a new oversight system for the treatment of substance use disorders (SUDs) with Medication Assisted Treatment (MAT) for OUDs (42 CFR part 8).  SAMHS A-approved accrediting bodies evaluate OTPs and perform site visits to ensure SAMHSAs opioid dependency treatment standards are met .  SAMHSA also requires OTPs to be accredited by a SAMHSA -approved accrediting body ( 8.11). The SAMHSA regulations establish procedures for an entity to apply to become a SAMHSA -approved accrediting body ( 8.3).  There are currently six SAMHSA -approved accreditation bodies.2  D. Have in effect a provider agreement under 42 CFR 489.   All providers of services under section 1866 of the Act must enter into a provider agreement with the Secretary and comply with other requirements specified in that section.  These requirements are codified at 42 CFR part 489.   40 - Bundled payments for OUD treatment services  (Rev. 268:  Issued; 02 -14-20: Effective; 01 -01-20: Implementation: 03 -16-20)  Section 1834(w) of the Act directs the Secretary to pay to the OTP an amount that is equal to 100 percent of a bundled payment for OUD treatment services that are furnished by the OTP to an individual during an episode of care.    The bundled payments for OUD treatment services include the medications approved by the FDA under section 505 of the FFDCA for use in the treatment of OUD; the dispensing and administration of such medication, if applicable; substance use counseling; individual and group therapy; and toxicology testing.   In calculating the bundled payments, a separate payment methodology applies for the drug component (which includes the medications approved by the FDA under section 505 of the FFDCA for use in the treatment of OUD) and the non- drug component (which include s the dispensing and administration of such medications, if applicable; substance use counseling; individual and group therapy; and toxicology testing) of the bundled payments.  The full bundled payment rate is calculated by combining the drug component and the non- drug components.     40.1.1 Aspects of the bundle  (Rev. 12418; Issued: 12- 21-23; Effective: 01 -01-24; Implementation: 01- 24-24)  A. Duration  of the  bundle   The duration of an episode  of care for OUD treatment  services  is a week  (that is, a contiguous  7-day period that may start on any day of the week).   1. Requirements  for an episode   SAMHSA requires OTPs to have a treatment plan for each patient that identifies the frequency with which items and services are to be provided ( 8.12(f)(4)). There is a range of service intensity depending on the severity of a patients OUD and stage of treatment. The threshold to bill an episode of care will be that at least one OUD treatment service was furnished (from either the drug  or non- drug component) to the patient during the week  that corresponds  to the episode  of care,  the OUD treatment  services  are described  in Section 20  Definitions relating to OTPs, C. Opioid use disorder treatment service. For intensive outpatient services furnished by OTPs and described by HCPCS code G0137, the threshold to bill is a minimum of nine services over a 7- contiguous day period. The types of intensive outpatient services that would qualify to meet this threshold is described in  410.67(b)(ix) in the definition of OTP intensive outpatient services.   2. Non-drug  episode  of care