Opioid Treatment Programs

Social Security Act (SSA) Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR Part 8 Medication Assisted Treatment for Opioid Use Disorders

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 17 Opioid Treatment Programs (OTPs)

OTP treatment is considered reasonable and necessary for beneficiaries meeting all of the following requirements:

• diagnosed with OUD using the Diagnostic and Statistical Manual for Mental Disorders, AND
• voluntarily chooses maintenance treatment, AND
• is currently addicted to an opioid drug

Initial assessment:

Upon admission to the OTP and before initiating pharmacotherapy, the beneficiary must undergo an initial assessment as part of the intake activities that complies with 42 CFR 8.12 (f)(2) and (4). To qualify as an initial assessment the following must be addressed and included in the documentation:

• Confirmation of the OUD diagnosis
• Complete medical history inclusive of concomitant medical conditions, psychiatric disorders, trauma, infectious disease, and pregnancy
• Physical exam (unless assessment is performed via telehealth)
• Mental health screening for psychiatric disorders
• Laboratory testing to include complete blood count, liver enzyme testing, tuberculosis screening, hepatitis B + C, and HIV. If laboratory testing is not performed, documentation of recent testing or the rationale for not testing must be included.
• Authenticated informed consent inclusive of treatment options discussed, risk/benefit consideration of pharmacotherapy, and the patient’s preferences for therapy.
• Formation of treatment plan with discussion of psychosocial treatment, support, and patient’s preference for these services.
• Assessment of withdrawal potential and the associated plan.
• Assessment of safety including overdose potential, prevention education, and offer of take-home naloxone.

Drug Testing:

Testing for drugs of abuse must be provided in accordance with 42 CFR 8.12(f)(6).

The use of other addictive drugs of abuse should not be a reason to withhold or suspend OUD treatment. However, those who are actively using substances during OTP are likely to require greater support including a more intensive level of care.

Periodic assessments are required in accordance with 42 CFR 8.12(f)(4). Periodic assessments must include documentation of the following:

• Evaluation of treatment progress and appropriate adjustments in therapy
• Review of drug abuse testing and assessment of compliance
• Review of psychosocial needs and plan to address unmet needs (if any)
• Documentation that substantiates necessity for a periodic visit

Covered Providers:

Care must be provided by one or a combination of the following providers and take place as part of a certified opioid treatment program as delineated in 42 CFR 8.11:

• Physicians (MD/DO)
• Clinical psychologists
• Licensed Clinical Social Workers
• Nurse practitioners
• Clinical Nurse Specialists
• Physician Assistants
• Other providers of mental health services licensed or otherwise authorized by the state in which they practice (e.g., licensed professional counselors, licensed clinical alcohol and drug counselors, licensed marriage and family therapists, licensed clinical alcohol and drug counselors, certified peer specialists)

Duration of treatment:

There is no limitation to the duration of treatment.

All coverage criteria must be clearly documented in the patient’s medical record and made available to the A/B MAC upon request.

OUD is described by the CDC as a problematic pattern of opioid use that causes significant impairment or distress. The United States has experienced a sharp increase in the incidence of opiate use disorder over the last 3 decades. In 2020, 91,799 drug overdose deaths occurred in the US and an estimated 2.7 million people ages 12 or older reported having an OUD.¹ This corresponds with increased use of both prescription and illicit opioids. The number of overdose deaths due to opioids, including prescription opioids, heroin, and synthetic opioids was 10 times higher in 2021 than in 1999.²

The effect of opioid agonists on mortality:

Santo et al performed a systematic review and meta-analysis of 15 randomized controlled trials (RCT) and 36 primary cohort studies.³ The study found that the risk of all-cause, overdose, suicide, alcohol-related, cancer, and cardiovascular-related mortality was significantly lower for people with opioid dependence during opioid agonist treatment (OAT). The rate of all-cause mortality during OAT was more than half of the rate seen during time out of OAT. The findings were not significantly different when comparing methadone vs buprenorphine. Notably, the all-cause mortality was 6 times higher in the 4 weeks after OAT cessation.

Krawczyk et al studied a total of 48,274 adults admitted to outpatient specialty treatment programs in 2015-16 for primary diagnosis of opioid use disorder in Maryland.⁴ The study population experienced 371 opioid overdose deaths. Periods in medication treatment were associated with substantially reduced hazard of opioid overdose death compared with periods in non-medication treatment. Periods after discharge from non-medication treatment and medication treatment had similar and substantially elevated risks compared with periods in non-medication treatments. Methadone and buprenorphine were associated with significantly lower overdose death compared with non-medication treatments during care but not after treatment is discontinued.

Pearce et al evaluated outcomes of 55,347 people with opioid use disorder who received OAT between 1 January 1996 and 30 September 2018.⁵ The all-cause standardized mortality ratio was substantially lower on OAT (4.6) than off OAT (9.7). Retention on OAT was associated with substantial reductions in the risk of mortality for people with opioid use disorder. The protective effect of OAT on mortality increased as fentanyl and other synthetic opioids became common in the illicit drug supply.

Effectiveness of Agonists:

Mattick et al reviewed 31 studies evaluating buprenorphine maintenance compared to placebo and to methadone maintenance in the management of opioid dependence.⁶ The overall conclusions revealed buprenorphine to be an effective medication in the maintenance treatment of heroin dependence, retaining people in treatment at any dose above 2 mg and suppressing illicit opioid use (at doses 16 mg or greater) based on placebo-controlled trials. However, compared to methadone, buprenorphine retained fewer people when doses are flexibly delivered and at low fixed doses. If fixed medium or high doses are used, buprenorphine and methadone appear no different in effectiveness (retention in treatment and suppression of illicit opioid use).

In a 2009 meta-analysis of 11 studies, Mattick et al evaluated 1969 participants for the effectiveness of methadone maintenance therapy.⁷ Methadone appeared statistically significantly more effective than non-pharmacological approaches in retaining patients in treatment and in the suppression of heroin use. Methadone was determined to be an effective maintenance therapy intervention for the treatment of heroin dependence as it retains patients in treatment and decreases heroin use better than treatments that do not utilize opioid replacement therapy. It does not show a statistically significant superior effect on criminal activity or mortality.

Klimas et al evaluated the retention rates reported by randomized controlled trials (RCTs) and controlled observational studies that compared methadone to buprenorphine (or buprenorphine-naloxone).⁸ The overall conclusion stated the meta-analysis of existing RCTs suggests retention in oral fixed-dose opioid agonist therapy with methadone appears to be generally equal to buprenorphine (or buprenorphine-naloxone)

Degenhardt et al examined buprenorphine compared with methadone in the treatment of opioid dependence across a wide range of primary and secondary outcomes.⁹ The study included 32 RCTs and 69 observational studies comparing buprenorphine and methadone, in addition to 51 RCTs and 124 observational studies that reported on treatment retention with buprenorphine. Evidence from the studies suggest that treatment retention is better for methadone than for sublingual buprenorphine. Comparative evidence on other outcomes examined showed few statistically significant differences and was generally based on small numbers of studies.

Naloxone and Education

Walley et al assessed the impact of state supported overdose education and nasal naloxone distribution (OEND) programs on rates of opioid related death from overdose and acute care utilization.¹⁰ OEND was implemented among opioid users at risk for overdose, social service agency staff, family, and friends of opioid users. Communities that implemented OEND had significantly reduced adjusted rate ratios compared with communities with no implementation. Opioid overdose death rates were reduced in communities where OEND was implemented. This study provides observational evidence that by training potential bystanders to prevent, recognize, and respond to opioid overdoses, OEND is an effective intervention.

McDonald et al reviewed 1164 records from 22 observational studies regarding the effectiveness of take-home naloxone programs.¹¹ Using Bradford Hill criteria, they found epidemiologic evidence that these programs reduced overdose mortality among participants and have a low rate of adverse events.

Patient preferences and service needs

Friedrichs et al reviewed 25 trials that were conducted between 1986 and 2014.¹² In their evaluation, two studies found that patients with substance use disorder preferred to be actively involved in treatment decisions and three studies showed that matching patients to their preferences resulted in a reduction of substance use. However, several studies found no statistically significant effect. The findings related to shared decision making differed across patient populations and optional therapeutic techniques.

Friedman et al analyzed prospective data from a US cohort of addiction treatment patients who reported service needs beyond core rehabilitative services (n = 3103).¹³ Matching comprehensive services to needs during treatment improved their drug use outcomes in the year following treatment relative to the year before. The strongest effects on drug use improvement were from matching needs for vocational and housing services.

Assessment and Treatment Plan:

In the 2020 focused update, the American Society of Addiction Medicine (ASAM) made the following recommendations regarding the initial evaluation of patients beginning treatment for opiate use disorder¹⁴:

• Completion of the patient’s medical history should include screening for concomitant medical conditions including psychiatric disorders, infectious diseases, acute trauma, and pregnancy.
• A physical examination should be completed as a component of the comprehensive assessment process.
• Initial laboratory testing should include a complete blood count, liver enzyme tests, and tests for TB, hepatitis B and C, and HIV.
• Patients being evaluated for OUD, and/or for possible medication use in the treatment of OUD, should undergo (or have completed) an assessment of mental health status and possible psychiatric disorders.

In the 2014 publication by the ASAM entitled ‘Standards of Care for the Addiction Specialist Physician’¹⁵ the following recommendation was made regarding therapeutic alternatives, ‘The addiction specialist physician discusses and offers all available clinically indicated psychosocial and pharmacological therapies to all patients, assisting the patient to collaborate in clinical decision-making, assuring that the patient is aware of therapeutic alternatives. This will include the advantages and disadvantages of medications for addiction, taking into consideration cost, availability, and potential for diversion. When pharmacotherapies are part of the treatment plan, the addiction specialist physician decides with the patient about the setting for treatment, assuring appropriate dosage and duration for the medication, monitors adherence, and assures psychosocial therapies occur throughout the treatment process.’

OUD is a national health crisis with high morbidity and mortality. In order to meet the needs of beneficiaries, Medicare began coverage for OTPs in January of 2020. Appropriate treatment may vary based on the needs of the patient so a carefully considered and individually tailored treatment plan is necessary.

Numerous studies support the use of pharmacotherapy in an OTP.^6-9 Studies suggest this method has the highest success rate while also significantly decreasing the mortality rates associated with OUD. Although the use of pharmacotherapy is not a requirement, it should be offered, and the benefits discussed. There is ongoing debate as to the most effective method of pharmacotherapy. There is high quality evidence supporting the use of both methadone and buprenorphine.

Current literature suggests cessation of OAT in OTPs is associated with a significant spike in mortality and relapse.^3-4 For this reason, there is no limit to the duration of pharmacotherapy, and the beneficiary should be made aware of these risks when making the decision to stop use.

Incorporating patient preferences and needs into the treatment plan for OUD appears to increase adherence and overall success of therapy. ASAM guidelines recommend a detailed initial assessment to properly identify these preferences and needs. Using a shared decision-making model has been suggested in some of the literature, but there is not significant evidence for it to be a requirement. However, a reasonable discussion communicating the treatment options available, the risks and benefits of each, and incorporating the individual’s perspectives are an important part of successful therapy.

1. Hedegaard H, Miniño AM, Spencer MR, Warner M. Drug overdose deaths in the United States, 1999–2020. NCHS Data Brief, no 428. Hyattsville, MD: National Center for Health Statistics. 2021.

2. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2022. Accessed March 28, 2024. http://wonder.cdc.gov

3. Santo T Jr, Clark B, Hickman M, et al. Association of Opioid Agonist Treatment With All-Cause Mortality and Specific Causes of Death Among People With Opioid Dependence: A Systematic Review and Meta-analysis [published correction appears in JAMA Psychiatry. 2021 Sep 1;78(9):1044] [published correction appears in JAMA Psychiatry. 2022 May 1;79(5):516] [published correction appears in JAMA Psychiatry. 2023 Sep 1;80(9):972]. JAMA Psychiatry. 2021;78(9):979-993.

4. Krawczyk N, Mojtabai R, Stuart EA, et al. Opioid agonist treatment and fatal overdose risk in a state-wide US population receiving opioid use disorder services. Addiction. 2020;115(9):1683-1694.

5. Pearce LA, Min JE, Piske M, et al. Opioid agonist treatment and risk of mortality during opioid overdose public health emergency: population based retrospective cohort study. BMJ. 2020;368:m772. Published March 31, 2020.

6. Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014;2014(2):CD002207. Published February 6, 2014.

7. Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009;2009(3):CD002209. Published July 8, 2009.

8. Klimas J, Hamilton MA, Gorfinkel L, Adam A, Cullen W, Wood E. “Retention in opioid agonist treatment: a rapid review and meta-analysis comparing observational studies and randomized controlled trials.” Syst Rev. 2021;10(1):216.

9. Degenhardt L, Clark B, Macpherson G, et al. Buprenorphine versus methadone for the treatment of opioid dependence: a systematic review and meta-analysis of randomised and observational studies [published correction appears in Lancet Psychiatry. 2024 Apr;11(4):e8]. Lancet Psychiatry. 2023;10(6):386-402.

10. Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis. BMJ. 2013;346:f174. Published January 30, 2013.

11. McDonald R, Strang J. Are take-home naloxone programmes effective? Systematic review utilizing application of the Bradford Hill criteria. Addiction. 2016;111(7):1177-1187.

12. Friedrichs A, Spies M, Härter M, Buchholz A. Patient Preferences and Shared Decision Making in the Treatment of Substance Use Disorders: A Systematic Review of the Literature. PLoS One. 2016;11(1):e0145817. Published January 5, 2016.

13. Friedmann PD, Hendrickson JC, Gerstein DR, Zhang Z. The effect of matching comprehensive services to patients' needs on drug use improvement in addiction treatment. Addiction. 2004;99(8):962-972.

14. The ASAM national practice guideline for the treatment of opioid use disorder: 2020 focused update [published correction appears in J Addict Med. 2020 May/Jun;14(3):267]. J Addict Med. 2020;14(2S Suppl 1):1-91.

15. American Society of Addiction Medicine. 2014 Standards of Care for the Addiction Specialist Physician. 2014.

• Provider Education/Guidance

• Opioid Treatment Programs
• OTP
• opiate use disorder
• OUD