evekhm/cms_iom_500 huggingface dataset:
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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).
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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.
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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.
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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.
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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
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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   In addition to bundled payments for an episode of care that are based on the medication administered for treatment (and include both a drug and non- drug component), the non- drug episode of care provides a mechanism  for OTPs  to bill for non-drug services,  including substance  use counseling, individual  and group therapy, and toxicology testing that are rendered during weeks when a medication is not administered, for  example,  in cases  where  a patient  is being treated with  injectable buprenorphine  or naltrexone  on a monthly basis or has a buprenorphine implant.  B. Drug  and non-drug  component   In establishing the bundled payment rates, CMS developed separate payment methodologies for the drug component  and the non-drug component  (which  includes  the dispensing and administration  of medication,  if applicable; substance use counseling; individual and group therapy; and toxicology testing) of the bundled payment. Each of these components is discussed in this section.  1. Drug  component
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The OTP  bundled payment rates  are based,  in part, on the  type of medication  used  for treatment.  The categories  reflect  those  drugs  currently  approved by the FDA under  section  505 of  the FFDCA  for use in treatment of OUD: that is, methadone (oral), buprenorphine (oral), buprenorphine (injection), buprenorphine (implant), and naltrexone (injection)).   Additionally, as CMS anticipates that there may be new FDA -approved opioid agonist and antagonist treatment  medications  to treat  OUD in the future. In the  scenario  where  an OTP  furnishes  MAT  using a new FDA -approved opioid agonist  or antagonist  medication  for OUD treatment that  is not specified  in one of our existing codes, the OTPs would bill for the episode of care using the medication not otherwise specified (NOS) code (HCPCS code G2075).  In such cases, CMS would use the typical or average maintenance dose to determine the drug cost for the new  bundle, which  contractors  would then add to the non-drug component  payment  amount  that corresponds with the relevant payment for drug administration (oral, injectable, or implantable) to determine the total bundled payment for the episode of care. Please refer to Pub 100- 04, Medicare Claims Processing Manual, Chapter 39 for claims processing information.   2. Non-drug  component  Counseling,  Therapy,  Toxicology Testing  and Drug  Administration   The non-drug component  of the OUD treatment services  includes  all items  and services  furnished  during an episode of care except for the medication, specifically counseling, therapy, toxicology testing and drug administration.
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The non-drug component  of the OUD treatment services  includes  all items  and services  furnished  during an episode of care except for the medication, specifically counseling, therapy, toxicology testing and drug administration.   OTPs must provide adequate substance abuse counseling to each patient as clinically necessary. Section 1861(jjj)(1)(C) of the Act, as added by section 2005(b) of the SUPPORT Act defines OUD treatment services  as including substance use counseling by a professional  to the extent  authorized  under  state law to furnish such services. Therefore, professionals furnishing therapy or counseling services for OUD treatment must be operating within State law and scope of practice. These professionals could include l icensed professional counselors, mental health counselors, licensed clinical alcohol and drug counselors, licensed marriage and family therapists,  and certified peer specialists that are permitted to furnish this type of therapy or counseling by state law and scope of practice. To the extent that the individuals furnishing therapy or counseling services are not authorized under state law to furnish s uch services, the therapy or counseling services would not be covered as OUD treatment services.   OTPs  are required  to 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. These drug abuse tests (which are identified as toxicology tests in the definition of OUD treatment services in section 1861(jjj)(1)(E) of the Act) are use d for diagnosing, monitoring and evaluating progress in treatment. The testing typically includes tests for opioids and other controlled substances. Urinalysis  is primarily  used for this testing; however,  there are other  types  of testing  such as  hair or fluid analysis that could be used. Any of these types of toxicology tests (such as  presumptive  and definitive  toxicology tests)  would be considered  to be OUD treatment  services and would be included in the bundled payment for services furnished by an OTP.  The non-drug component  of the bundle  also includes  the cost of drug dispensing and/or  administration,  as applicable.   C. Adjustment  to the bundled payment  rates
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C. Adjustment  to the bundled payment  rates   Bundled payment rates may be adjusted by use of add- on codes for intake activities, periodic assessments, take -home supplies of methadone, take -home supplies of oral buprenorphine, additional counseling or group or individual therapy to be furnished for a particular patient that substantially exceeds the amount specified in the patients individualized treatment plan, and intensive outpatient program services .   If the OTP furnishes a take -home supply of 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, an adjustment to the bundled payment rates will be made when these medications are dispensed. The adjustment will be limited to  once  every  30 days, except  when a  further take- home  supply of these medications  is medically  reasonable and necessary. The opioid treatment program must document in the medical record the reason(s) for the exception.   OTPs that furnish intensive outpatient program services must meet the requirements stated in the definition of OTP intensive outpatient services at 410.67(b)(ix), in the certification and plan of treatment at 410.67(c)(5), and in the billing threshold mentioned at 410.67(4)(i)(F).    Additional  information  regarding the add-on codes  can be found at  Pub 100-04, Medicare Claims  Processing Manual, Chapter 39.  D. Site of service  (telecommunications)
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Additional  information  regarding the add-on codes  can be found at  Pub 100-04, Medicare Claims  Processing Manual, Chapter 39.  D. Site of service  (telecommunications)   OTPs are allowed to furnish the  substance  use counseling, individual therapy, and group therapy included in the bundle via two- way interactive audio -video communication technology, as clinically appropriate, in order  to increase access  to care for  beneficiaries.  In addition, initiation  of treatment  with  buprenorphine  (but not methadone)  via the OTP intake add -on code may be furnished via two -way audio- video communications technology to the extent  that the use of audio- video telecommunications  technology to initiate  treatment  with buprenorphine is authorized by DEA and SAMHSA at the time the service is furnished.  For additional information please refer to Section 20  Definitions relating to OTPs, C. Opioid use disorder treatment service. During the Public Health Emergency (PHE) for the COVID- 19 pandemic, as well as after the conclusion of the PHE, therapy and couns eling 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.   Beginning January 1, 2021, OTPs are allowed to use two- way interactive audio -video communication technology, as clinically appropriate, to furnish the periodic assessment add- on code. Additionally, during the PHE which expired on May 11, 2023, in cases where a beneficiary did not have access to two-way audio- video communications technology, periodic assessments could be furnished using audio- only telephone calls if all other  applicable requirements  were met. 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.
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Beginning January 1, 2023, OTPs are allowed to furnish the OTP intake add- on code via two -way audio-  video communication technology when  billed  for the initiation  of treatment  with buprenorphine, to the extent that the use of audio- video telecommunications technology to initiate treatment with buprenorphine is authorized by DEA and SAMHSA at the time the service is furnished. OTPs are also allowed to use audio-  only communication technology to initiate treatment with buprenorphine in cases where audio -video technology is not available to the beneficiary, including circumstances in which the beneficiary is not capable of or has not consented to the use of devices that permit a two- way, audio/video interaction.   OTPs providing intensive outpatient services to Medicare beneficiaries with an OUD shall not receive payment under Medicare part B if the intensive outpatient services are furnished via audio- video or audio- only communications technology.   Telemedicine services  should not, under  any 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.   Counseling or therapy  furnished  via communication technology as part of OUD treatment  services furnished by an OTP must not be separately billed by the practitioner furnishing the counseling or therapy because these services would already be paid through the bundled payment made to the OTP.  E. Coding   A coding structure  for OUD treatment  services  was adopted that varies  by the medication  administered.  The codes and long descriptors for the OTP bundled services and add -on services are:   HCPCS  code  G2067:  Medication  assisted  treatment,  methadone;  weekly  bundle  including dispensing  and/or administration, substance  use counseling, individual  and group therapy, and toxicology testing,  if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS code G2068: Medication assisted treatment, buprenorphine (oral); weekly bundle including dispensing and/or  administration,  substance  use counseling, individual  and group therapy, and  toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program)
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HCPCS  code  G2069:  Medication  assisted  treatment,  buprenorphine  (injectable);  weekly  bundle  including dispensing and/or  administration,  substance use counseling, individual  and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS code G2070: Medication assisted treatment, buprenorphine (implant insertion); weekly bundle including dispensing and/or  administration,  substance  use counseling, individual  and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS code G2071: Medication assisted treatment, buprenorphine (implant removal); weekly bundle including dispensing and/or  administration,  substance  use counseling, individual  and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS  code  G2072:  Medication  assisted  treatment,  buprenorphine  (implant insertion  and removal);  weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS  code  G2073:  Medication  assisted  treatment,  naltrexone;  weekly  bundle  including dispensing  and/or administration, substance use  counseling, individual and group therapy, and toxicology testing  if performed (provision of the services by a Medicare- enrolled Opioid Treatment Program).   HCPCS code G2074: Medication assisted treatment, weekly bundle not including the drug, including substance  use counseling, individual  and group therapy,  and toxicology testing  if performed  (provision of the services by a Medicare -enrolled Opioid Treatment Program).   HCPCS code  G2075: Medication assisted treatment, medication not otherwise  specified; weekly  bundle including dispensing and/or  administration,  substance  use counseling, individual  and group therapy, and toxicology testing, if performed (provision of the services by a Medicare -enrolled Opioid Treatment Program).