MAT Statement Of Work 2023.pdf

COMMUNITY TREATMENT SERVICES

(CTS)

MEDICATION-ASSISTED

TREATMENT (MAT)

OCTOBER 2023

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CHAPTER ONE: INTRODUCTION

1.1 PURPOSE. The purpose of this Community Treatment Services (CTS) Statement of Work (SOW) is to outline the government's technical requirements for Contractors who provide medication-assisted treatment (MAT) for adults in custody of the Bureau of Prisons (Bureau) while residing in a Residential Reentry Center (RRC), on Home Confinement (HC), on Federal Location Monitoring (FLM) or reporting to a Day Reporting Center (DRC).

1.2 SCOPE. The scope includes community substance use disorder treatment for adults in custody with an opioid use disorder (OUD) or an alcohol use disorder (AUD) using a Food and Drug Administration (FDA) approved medication (methadone, buprenorphine or buprenorphine with naloxone, and naltrexone) in combination with clinically indicated cognitive behavioral counseling.

1.3 CONTRACT PERFORMANCE. All services will comply with the SOW; the U.S.

Constitution; all applicable federal, state, and local laws and regulations; applicable Presidential Executive Orders (E.O.); all applicable case law; and court orders. The Bureau reserves the right to issue interim guidance that supersedes policy. The Contractor will comply with and implement any applicable changes to Bureau policy, Department of Justice (DOJ) regulation, Congressional mandate, federal law or Presidential Executive Orders.

The Bureau reserves the right to conduct announced and unannounced inspections by various staff of any part of the Contractor’s operation at any time and method deemed reasonable by the Bureau to assess contract performance and compliance.

The Bureau, or other appropriate agency, may investigate any incident pertaining to the performance of this contract. The Contractor must comply and cooperate with the Bureau, or other appropriate agency, on all investigations, inspections, and inquiries.

The Bureau reserves the right to enter into negotiations with the Contractor to change the conditions or procedures in this SOW and the contract. The Contractor will submit any request for contract modifications through the Federal Acquisition Certification Contracting Officer’s Representative (FAC COR) for evaluation. Only the Bureau’s Contract Officer (CO) may approve contract modifications. Contract modifications must be in the best interest of the Government.

CHAPTER TWO: BUREAU INFORMATION

2.1 THE BUREAU’S MAT PROGRAM. Studies show up to 65% of adults in custody meet the criteria for a substance use disorder, with up to one-quarter of these having an OUD. The impact of opioid use on individuals transitioning from prisons to the

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community is overwhelmingly negative. Formerly incarcerated individuals are 40 times more likely to die from an opioid overdose in the two weeks following release.

There is overwhelming evidence that MAT is an effective intervention for addressing OUD in criminal justice populations. When monitored and properly used, MAT is an effective, safe, and cost-effective treatment.

In February 2019, as required by the First Step Act, the Bureau implemented a Medication Assisted Treatment (MAT) Program to include the use of all three (3) approved FDA medications for the treatment of OUD. By May 2019, the MAT program had expanded to all Bureau institutions nationwide. Adults in custody are now eligible to participate in MAT during their incarceration through continuation of treatment upon entering Bureau custody or by initiating or restarting treatment in preparing for release from custody.

2.2 INSTITUTION MEDICATION-ASSISTED TREATMENT (MAT). The

Bureau offers MAT to adults in custody with an opioid use disorder while incarcerated and during their community placement. MAT is available on a voluntary basis and treatment may be declined at any time. Adults in custody receive a medication regimen and can participate in evidence- based counseling.

2.2.1 Institution MAT Participants. Those entering Bureau custody are screened and evaluated by psychology and health services department for an opioid use disorder, with continuation of MAT when clinically appropriate. To address the increased risk of recidivism and relapse for adults in custody with a history of an OUD, MAT is initiated, if needed, in preparation for RRC placement or home confinement. Providing MAT during the high-risk re-entry period is particularly important as it enhances the ability to resist opioid-seeking behaviors while in the community.

2.2.2 CTS MAT Referrals. Adults in custody who are active in MAT while incarcerated are referred by CTS to continue while in the community.

Additionally, any adult in custody who is evaluated by a qualified practitioner in the community and recommended for MAT will be authorized by CTS for all necessary treatment.

CHAPTER THREE: MAT OVERVIEW

3.1 MEDICATION-ASSISTED TREATMENT (MAT). MAT is the use of one of the three FDA approved medications for the treatment of OUD in combination with clinically indicated behavioral or cognitive-behavioral counseling and other indicated services. MAT is evidence-based and is the recommended course of treatment for OUD by the National Institute of Drug Abuse, Substance Abuse & Mental Health Services Administration, and the Centers for Disease Control & Prevention as the first line of treatment.

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Behavioral or cognitive-behavioral counseling, in combination with medications for OUD or AUD, is associated with improved outcomes and is effective in treating substance use disorders. Cognitive Behavioral Therapy, Motivational Interviewing, Rational Emotive Behavior Therapy, or Mindfulness Based Cognitive Therapy, delivered in a group or individual setting, is a necessary component of a MAT program and is the generally accepted standard of care.

Under federal law, MAT clients receiving treatment in an opioid treatment program (OTP) must receive counseling, which may include different forms of behavioral counseling. These services are required along with medical, vocational, educational, and other assessment and treatment services.

Regardless of what setting medication is provided, it is more effective when counseling and other services are available to provide clients with a whole-person approach and to support their recovery.

3.2 MAT MEDICATIONS. Current FDA-approved medications for OUD include methadone, buprenorphine, and naltrexone. Both methadone and buprenorphine can reduce the symptoms of withdrawal and cravings—without producing euphoria when taken as directed. Alternatively, naltrexone is useful to prevent relapse to opioid use and helps reduce the risk of fatal overdose after release from the criminal justice system.

A medication approved by the FDA to treat both AUD and OUD is naltrexone. It blocks the effects and feelings of alcohol and reduces alcohol cravings and the amount of alcohol consumed. Although it does not provide a cure for AUD, it is most effective when used as part of a MAT program.

3.2.1 Methadone. Methadone, a long-acting opioid agonist, is a Schedule II drug, that reduces opioid craving and withdrawal and blunts or blocks the effects of opioids. Methadone, taken daily, is available in liquid, powder, and diskettes forms, which is dispensed only through an opioid treatment program (OTP), that has been certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and registered as a narcotic treatment program by the U.S. Drug Enforcement Agency (DEA).

3.2.2 Buprenorphine. Buprenorphine, an opioid partial agonist, is a Schedule III drug, indicating its lower potential for abuse or misuse than Schedule II substances. It can help to diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings, and block the effects of opioids.

Buprenorphine is the first medication to treat OUD that can be prescribed or dispensed in an office-based setting.

Buprenorphine products approved by the FDA for the treatment of OUD include:

buprenorphine/naloxone sublingual tablets, buprenorphine sublingual tablets, buprenorphine/naloxone sublingual films, buprenorphine/naloxone buccal films, COMMUNITY TREATMENT SERVICES | MEDICATION-ASSISTED TREATMENT | OCTOBER 2023 4 buprenorphine extended-release injections, and buprenorphine implants. Tablets and films require once-daily maintenance dosing, while the injectable buprenorphine is administered subcutaneously in the abdomen monthly.

Buprenorphine implants are for subdermal insertion on the inside of the upper arm and provide six months of buprenorphine and must be removed after six months.

3.2.3 Naltrexone. Naltrexone, an opioid antagonist, can be prescribed and administered by any practitioner licensed to prescribe medications, and is available in a pill form for AUD or as an extended-release intramuscular injectable for either AUD or OUD. A Risk Evaluation and Mitigation Strategy (REMS) is required for the long-acting injectable formulation to ensure that the benefits of the drug outweigh its risks. The pill form can be taken daily for AUD, but the extended-release injectable formulation is approved for the treatment of OUD. The pill form is taken daily and the extended-release injectable is administered every four weeks, or once a month, by a practitioner.

3.3 MAT PROGRAM SETTINGS. Federal laws and statutes regulate the medications used in treating OUD and where they can be prescribed and/or administered.

Exclusive of naltrexone, which may be prescribed and administered in any provider setting, methadone and buprenorphine are generally utilized in one of two different settings: opioid treatment programs (OTPs) or an office-based opioid treatment

(OBOT).

3.3.1 Opioid Treatment Program (OTP). Title 42 of the Code of Federal

Regulations Part 8 (42 CFR § 8) sets the standards for an opioid treatment program (OTP). Under these federal regulations, an OTP is required to have current valid accreditation status from an independent, SAMHSA approved accrediting body, SAMHSA certification, and DEA registration before they are able to administer or dispense OUD medications. All OTPs must also be licensed by the state in which they operate. An OTP must meet certain standards, including having a specific administrative and organizational structure, continuous quality improvement, credentialed staff, specified patient admission criteria, drug testing, a confidential recordkeeping system, medication provision standards, and counseling, vocational, and educational services. Only certified, accredited, and licensed OTPs can provide methadone but can also provide buprenorphine and naltrexone for OUD.

3.3.2 Office-Based Opioid Treatment (OBOT). Office-based opioid treatment

(OBOT) are outpatient treatment services provided outside of licensed Opioid Treatment Programs (OTPs). Typically, OBOT provides a prescription for buprenorphine and the provision of naltrexone, in coordination with other medical and psychosocial interventions to achieve and sustain remission.

3.4 MAT STATE AND FEDERAL REGULATIONS. Federal and state laws and other policies may affect the prescribing and dispensing of medications for opioid

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use disorders. Medications for the treatment of opioid use disorders must be prescribed or dispensed by individuals who are licensed to perform these activities in the respective state(s) where services are rendered; however, additional rules and regulations apply to methadone and buprenorphine because of their status as controlled substances under the Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act [CSA],1970).

3.4.1 Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The Ryan

Haight Act amended the Controlled Substances Act (CSA) to significantly limit the conditions in which a controlled substance may be administered by telehealth. According to the act, a telehealth prescription for a controlled substance is only available if the treating physician has had a previous in- person assessment of the client and the prescription was signed for a specific medical purpose.

3.4.2 COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. In response to the public health emergency declaration related to the COVID-19 pandemic, in March 2020, SAMHSA and DEA temporarily adopted policies to the requirements for prescribing controlled substances via telehealth and allowed for increased use of telehealth for the treatment of OUD.

These policies allow practitioners, inside and outside of OTPs, to initiate buprenorphine treatment for new clients over the telephone or using an audio-visual connection without first requiring an in-person evaluation.

These policies allowed prescription of controlled substances without first conducting an in-person examination if all of the following conditions were met:

• The practitioner is able to conduct an adequate evaluation using telehealth (which includes the use of telephone in addition to an audio-visual connection).

• The practitioner is licensed by the relevant state regulatory authority.

• The practitioner is registered with the DEA to prescribe controlled substances.

• The practitioner is acting in the usual course of his/her professional practice to issue prescriptions for a legitimate medical purpose.

3.4.3 First Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. When the COVID-19 Public Health Emergency (PHE) expired on May 11, 2023, the DEA, jointly with SAMHSA, issued the First Temporary Rule, which extended the telehealth flexibilities adopted during the COVID-19 PHE. Effective from the day after the public health emergency ended, through November 11, 2024, the following temporary rule was in effect:

https://www.legitscript.com/blog/2021/03/a-post-pandemic-ryan-haight-act-may-create-uncertainty-for-telemedicine/?cn-reloaded=1

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• The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE would remain in place through November 11, 2023.

• Additionally, for any practitioner-patient telemedicine relationships that had been or would be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE would continue to be permitted via a one-year grace period through November 11, 2024.

3.4.4 Second Temporary Extension of COVID-19 Telemedicine Flexibilities for

Prescription of Controlled Medications. After the First Temporary Rule was issued, the DEA hosted listening sessions to receive additional input concerning the practice of telehealth with regards to prescribing controlled medications.

Consequently, in response to comments received regarding the First Temporary Rule and the listening sessions, the DEA issued a Second Temporary Rule, extending the full set of telehealth flexibilities regarding prescription of controlled medications as were in place during the COVID–19 PHE, through December 31, 2024.

This extension, issued on October 10, 2023, now authorizes all DEA-registered practitioners to prescribe controlled medications via telehealth through December 31, 2024, whether or not the patient and practitioner established a telehealth relationship on or before November 11, 2023.

The purpose of this Second Temporary Rule, like the one before it, is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telehealth for controlled medication prescriptions, as well as allow adequate time for providers to come into compliance with any new standards or safeguards. DEA is working to promulgate new standards or safeguards by the fall of 2024.

3.4.5 Consolidated Appropriations Act of 2023. On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the "DATA-Waiver Program,” increasing access to buprenorphine for those in need. The Act no longer required a DATA-Waiver registration to treat clients with buprenorphine for an OUD and all prescriptions for buprenorphine only required a standard DEA registration number. The Act also removed any limits on the number of clients a prescriber could treat for an OUD with buprenorphine. The Act did not impact existing state laws or regulations that may be applicable.

Separately, the Act also introduced new training requirements for all prescribers.

Beginning, June 27, 2023, all DEA-registered practitioners, except veterinarians, are required to complete a one-time, eight-hour training on the treatment and management of patients with opioid or other substance use disorders.

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CHAPTER FOUR: GUIDANCE ON PROVIDING MAT FOR CTS

4.1 MAT STANDARDS. The standards for providing MAT in Community Treatment Services must adhere to federal regulations, statutes, and guidelines, which govern medication-assisted treatment for treating opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of SAMHSA’s Center for Substance Abuse Treatment (CSAT), manages the day-to-day oversight activates required to implement federal regulations surrounding the use of medications, such as methadone and buprenorphine, for the treatment of OUD for practitioners and opioid treatment programs (OTPs).

The provision of MAT services, specific to CTS, shall be delivered according to the requirements outlined in this SOW.

4.1.1 Treatment Services. The Contractor shall deliver services in-person and by telehealth, defined as audio-visual, real time, two-way interactive communication, herein called TeleMAT. Audio-only technology may be utilized when audio-visual technology is not available or accessible by the client. All clinical services require an interaction between the client and an appropriately licensed and Bureau-approved Contractor.

Providing MAT services by telehealth is dependent on the type of drug being utilized, per federal law. States may also regulate OUD treatment via telehealth.

The Contractor must be aware of federal and state telehealth regulations, any additional regulations pertaining to OUD treatment, and be familiar with the laws in the state where clients are located, if delivering services across state lines.

4.1.2 TeleMAT. The Contractor shall provide services over real-time, audio and visual interactive telecommunications for telehealth sessions. Alternatively, audio only may be utilized when telehealth accessibility and capability is limited.

The Contractor must be aware of federal and state telehealth regulations and be familiar with the laws in the state where MAT clients are located, if delivering services across state lines.

4.1.3 Security. The Contractor must adhere to the Health Insurance Portability and Accountability Act (HIPAA) regulations and federal confidentiality rules when providing TeleMAT services. The Contractor shall verify audio and video transmission is encrypted. The Federal Information Processing Standard (FIPS) 140-2 is used by the U.S. government to accredit encryption standards. If partnering with 3rd party telehealth vendors, the Contractor must verify if their encryption meets the FIPS 140-2 certified 256-bit standard; that any peer-to-peer videoconferencing (streamed endpoint-to-endpoint) is not stored or intercepted by the company in any way; and that any recorded videoconferences or—if available—text-based chat sessions near the chat window are stored locally, on their own HIPAA-compliant device or electronic record keeping https://www.samhsa.gov/medication-assisted-treatment/about-dpt https://www.samhsa.gov/medication-assisted-treatment/about-dpt https://www.samhsa.gov/about-us/who-we-are/offices-centers/csat https://www.samhsa.gov/about-us/who-we-are/offices-centers/csat https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/methadone https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/buprenorphine

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system, in order to safeguard any electronic protected health information or

PHI.

4.1.4 Clinical Suitability. The Contractor must determine which clients are suitable for TeleMAT sessions based on clinical decision, available resources, and technology. The Contractor must also determine if a telehealth session is the most appropriate method of delivery for the type of service being rendered.

Clinical judgment must guide the use of telehealth for the delivery of services, and not simply for the sake of convenience for the Contractor or client.

4.1.5 Familiarization. The Contractor must be familiar with and comfortable operating and controlling their telehealth platform. Additionally, before conducting a TeleMAT session, the Contractor must provide information to the client on telehealth delivery of care and using the selected technology. The Contractor shall also provide information to the client on how to access any digital platform that may be used in the delivery of telehealth services.

4.1.6 Telehealth Informed Consent. The Contractor shall obtain a telehealth specific informed consent from the client, as required by state regulations, that explains:

what telehealth is, an alternative option for in-person services, confidentiality laws and protections, recording of telehealth sessions will not take place, any additional elements to comply with state requirements for telehealth services.

The Contractor must document in the Bureau’s electronic file management system (EFMS) whether verbal or written consent was obtained from the client.

Written consent is preferred.

4.1.7 Identity Verification. The Contractor shall verify the identity of the client prior to each TeleMAT session by confirming their legal name, date of birth, and Bureau register number listed on the treatment referral form. The Contractor shall document the verification on clinical documents and notes added to the

EFMS.

4.1.8 Originating Site Location. The Contractor shall be aware of the client’s originating site, to include the exact physical location and address, at the time of the TeleMAT session (e.g., the RRC, the client’s residence, or place of work), and document it in the EFMS. To maintain privacy, all individuals at each location must be identified and the client must consent to discussing confidential information with those individuals present or they should be asked to leave.

4.1.9 RRC Originating Site. If the local RRC has available equipment, and a secure and private location for telehealth appointments as the originating site, the Contractor shall coordinate appointment times to mitigate scheduling conflicts with available equipment and space.

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4.1.10 Distant Site. When conducting telehealth sessions at the distant site, the Contractor shall use a private location, with a neutral background, adequate lighting, and wear appropriate professional attire.

4.1.11 Alternative Sessions. The Contractor must conduct an in-person session with the client if they do not consent to the use of real-time video technology or audio only communication.

4.1.12 In-Person Visit Requirements. The Contractor must conduct an in-person session if the standard of care or current law or regulations require information or treatment that is only obtainable in-person. The place of performance for an in-person session must be within a reasonable distance (as determined by the FAC COR) from the location of the client’s assigned RRC, HC, FLM, or DRC.

4.1.13 Standards. The Contractor shall exercise the same standards of care for TeleMAT treatment, such as providing standard session lengths and documentation as in-person services.

4.1.14 Crisis Intervention. The Contractor must be aware of local crisis resources and have a plan for crisis intervention if a TeleMAT session, or in-person session, requires such services.

4.1.15 Informed Consent. The Contractor shall advise the client of the risks and benefits of the treatments available, to include MAT and non-MAT alternatives, and should also explain the risk of relapse with and without MAT, estimated duration of treatment, and reasonable expectations for treatment results. A written informed consent should be reviewed and signed by both the practitioner and the client.

4.1.16 Diagnosis. The Contractor must determine and establish the appropriate diagnosis for a client receiving MAT services. The Contractor shall refer to the DSM- 5 for specific criteria and guidance.

The DSM-5 criteria for OUD are based on identifying at least two out of 11 manifestations of “clinically significant impairment or distress” resulting from opioid use. The criteria must have occurred within any 12-month period, not necessarily the client’s previous 12 months or current presentation.

Based on the number of symptoms described in the DSM-5 criteria, the Contractor shall determine the severity of OUD:

• Mild: presence of 2 to 3 symptoms

• Moderate: presence of 4 to 5 symptoms

• Severe: presence of 6 or more symptoms

The Contractor shall also determine the status of the client based on current presentation:

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• In early remission: After full criteria for opioid use disorder were previously met, none of the criteria for opioid use disorder have been met for at least 3 months but for less than 12 months (with the exception of “Craving, or a strong desire or urge to use opioids,” may be met).

• In sustained remission: After full criteria for opioid use disorder were previously met, none of the criteria for opioid use disorder have been met at any time during a period of 12 months or longer (with the exception of “craving, or a strong desire or urge to use opioids,” may be met).

The DSM-5 also provides additional specifiers based on the following:

• On maintenance therapy (agonist or antagonist)

• In a controlled environment (includes the correctional environment)

4.1.17 Urine Drug Screening (UDS). Drug monitoring is a tool that provides information about an individual’s substance use. Urine Drug Screening (UDS) detects the presence or absence of specific drug(s) and drug metabolites in a urine sample within a specific timeframe. The Contractor shall utilize UDS to monitor adults in custody for adherence to medication and for the use of illicit and controlled substances to inform clinical decision making.

Adults in custody participating in CTS are drug tested no less than four times a month while in community placement for correctional reasons. The Contractor may utilize the correctional UDS to review the data for drug monitoring, if it meets the following conditions:

• Correctional UDS meets clinical requirements for monitoring adherence to medication and for use of illicit and controlled substances.

• Correctional UDS is made available to the Contractor as a courtesy and not as a requirement.

Urine drug screenings conducted for correctional reasons shall not be solely relied upon to meet clinical and contractual requirements for monitoring patients on medications for OUD. To meet these requirements, the Contractor must utilize the services of a local community-based testing center (e.g., LabCorp, C- Lab, Quest, etc.) to order a urine drug screening for the client and shall coordinate the referral with the RRC. The Contractor shall not provide or send urine cups or other types of testing containers to a client for urine collection.

4.1.17.1 Medical and Correctional Urine Drug Screenings. A client may receive urine drug screenings for medical reasons or for correctional reasons. These two programs are managed independently of one another. A positive result from a correctional urine drug screening may be used for disciplinary action if positive for anything other than prescribed medication(s). A positive finding from a medical urine drug screening may not be used for the disciplinary process and negative findings may not be used to contradict the

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disciplinary process. Instead, documentation of the result of a medical urine drug screening and follow-up with the client must occur.

4.1.17.2 Frequency of UDS. Pursuant to the Code of Federal Regulations for OTPs only, the Contractor shall require eight (8) UDS, at a minimum, per year for adults in custody on maintenance treatment with methadone or buprenorphine, For OBOT settings, to include TeleMAT, in which adults in custody are being treated with buprenorphine there are no mandatory UDS requirements. Ongoing clinical monitoring that includes UDS is part of a good practice in order to acquire objective evidence of any ongoing illicit substance use and confirm buprenorphine adherence. The Contractor must use clinical judgement to determine the frequency of drug screening, based on the phase of buprenorphine treatment, medication compliance, and for diversion control.

Ordinarily, the Contractor shall require a UDS at the time of the initial evaluation with buprenorphine. A UDS is a critical component of the evaluation as it can be used for treatment planning, provide baseline, objective information between subjective client reporting and objective drug testing, and enhance the accuracy of the diagnosis and appropriateness of the treatment plan.

During initiation and throughout the course of treatment, the Contractor shall continue urine drug screenings and order at least quarterly UDSs, or more frequent as clinically indicated, for adults in custody on maintenance treatment with buprenorphine.

4.1.18 Prescription Drug Monitoring Programs (PDMP). PDMPs are state-operated electronic databases that collect data on controlled substances dispensed in the states and help monitor whether the prescribed medication is being obtained, being obtained from other prescribers, or refilling prescriptions early. The Contractor shall inform the client that the PDMP shall be accessed to monitor their controlled prescription drug use.

4.1.19 Diversion. Diversion is defined as the unauthorized rerouting of prescription medication to someone other than for whom it was intended, including sharing or selling a prescribed medication. The Contractor must implement procedures for prevention of diversion, such as using buprenorphine/naloxone combination products when cost is not an issue and clinically indicated; counsel adults in custody on safe storage of, and non-sharing of medications; counsel adults in custody on taking medication as instructed and explicitly explain definitions of diversion and misuse; check PDMP for new referrals and check regularly thereafter; prescribe a therapeutic dose tailored to the client’s needs; and ensure client understands the treatment agreement and prescription policies.

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4.1.20 Individualized Treatment. There is no “one size fits all” treatment for adults in custody with an OUD and AUD. MAT provides a “whole-person” approach by combining medications with cognitive-behavioral counseling. Integrating evidence-based counseling into a client’s MAT program can modify attitudes and behaviors related to substance use, increase healthy life skills, and reduce risk factors. The person-centered approach to OUD and AUD treatment allows the client to make decisions such as whether to take medications, which medications to take, and whether to participate in counseling. The Contractor must individualize treatment according to the needs of the client by providing access to the most clinically appropriate and available FDA-approved medication to treat OUD or AUD. The Contractor should strongly encourage the client to participate in counseling services, but it is not required. Ordinarily, all counseling services will be delivered by a CTS contractor.

CHAPTER FIVE: SCOPE OF TREATMENT SERVICES

5.1. TREATMENT REFERRAL AND AUTHORIZATION. The Bureau will

provide a Treatment Referral and Authorization form for each adult in custody referred for MAT services. It will specify the authorized MAT services and service authorization period. Each service will include the corresponding contract line item number (CLIN). Services are only authorized from the start date to the end date, as indicated on the form. Amendments will be sent as necessary.

5.1.1. Authorized Services. The Contractor shall only provide services authorized on the Treatment Referral and Authorization. The Contractor may request clinically indicated changes to the client’s authorized services, including discontinuing treatment, by contacting the FAC COR.

5.1.2. Obligation to Treat. The Contractor must accept all referrals from the Bureau for treatment services. If the Contractor determines they cannot provide treatment to a particular client or condition, they must submit documentation that explains the issue to the Bureau within five (5) business days from receipt of the referral.

5.2. INITIAL CONTACT. Within two (2) business days from the treatment authorization start date (indicated on the Treatment Referral and Authorization), the Contractor must make initial contact with the referred client. The initial contact shall be conducted either in-person or via telehealth and include introductory information to the client, completion of Bureau forms, informed consent, and treatment agreement (if applicable). At the time of the initial contact, the Psychiatric Evaluation for MAT services will be scheduled according to the needs of the clients, either in-person or by telehealth, no later than ten (10) business days from the initial

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contact. The initial contact shall determine the clinical urgency of the evaluation for scheduling purposes.

5.2.1. MAT Intake Screening (CLIN 4005): Only if, at the time of the initial contact, the client declines participation in services is the MAT Intake Screening billed.

MAT Intake Screening must be submitted to the EFMS within one (1) business day of the initial contact. Intake screenings will not be reimbursed prior to receipt of the declined informed consent. Price is per intake screening.

5.3. PSYCHIATRIC EVALUATIONS AND REPORTS. Evaluations and similar services conducted by practitioners provide the Bureau with in-depth clinical information on the current status and diagnosis of the client. Additionally, practitioners utilizing medications for OUD should order baseline medical tests, including urine drug screens, as part of their initial evaluation of the client.

Ordinarily, necessary medical and laboratory tests (excluding urine drug screenings) are covered in the community by the Bureau’s comprehensive medical contract.

All reports must be submitted to the Bureau as soon as completed, but no more than the timeframes specified below. Unusual information must be conveyed to the FAC COR with the appropriate amount of urgency as deemed clinically necessary. The Bureau reserves the right to require Contractors to submit specific assessments in a shorter time frame when needed. Services may not be billed until the report is received by the Bureau.

5.3.1. MAT Psychiatric Evaluation and Report (CLIN 4050): Must be conducted in-person within ten (10) business days of the initial contact. The evaluation shall consist of an initial comprehensive diagnostic interview and medical assessment, to include ordering any necessary medical and laboratory tests, and ordering an initial urine drug screen (or reviewing UDS if one is made available).

The evaluation must assess current mental health functioning and status, as well as physical ability to participate in MAT. The report must provide a diagnosis, any co-occurring mental health disorders, and treatment recommendations.

Reports must be submitted to the EFMS within five (5) business days of evaluation. Evaluation services will not be reimbursed prior to receipt of the report. Price is per report.

5.3.2. TeleMAT - Psychiatric Evaluation and Report (CLIN 4054): Must be conducted by telehealth within ten (10) business days of the initial contact. The evaluation shall consist of an initial comprehensive diagnostic interview and medical assessment, to include ordering any necessary medical and laboratory tests, and ordering an initial urine drug screen (or reviewing UDS if one is made available). The evaluation must assess current mental health functioning and status, as well as physical ability to participate in MAT. The report must provide a diagnosis, any co-occurring mental health disorders, and treatment recommendations. Reports must be submitted to the EFMS within five (5)

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business days of evaluation. Evaluation services will not be reimbursed prior to receipt of the report. Price is per report.

5.4. MEDICATION SERVICES. Medication services include regular reviews of MAT medication effects and compliance as well as administration and dispensing of medications for an opioid use disorder. Ordinarily, medication costs are covered in the community by the Bureau’s comprehensive medical contract. Contract line items that include the cost of the drug will only be utilized as needed.

The Contractor shall be aware of and comply with local RRC procedures for processing routine and emergency prescriptions. The Contractor must immediately notify the RRC of any emergency prescriptions and the FAC COR must be notified within one (1) business day.

5.4.1. MAT - OTP Services (CLIN 4000): When authorized, the Contractor delivers MAT - OTP services, in accordance with SAMHSA’s Federal Guidelines for Opioid Treatment Programs. Covered services for MAT – OTP include: intake activities, clinical assessment, preparation of a treatment plan, periodic assessment, opioid-specific substance use disorder counseling, urine drug testing, and dispensing and/or administration of methadone, including the medication and take-home dosing. The Contractor must provide at least one (1) of the covered services daily for payment. Price is per daily rate.

5.4.2. MAT – Buprenorphine and Administration (CLIN 4021): When authorized, the Contractor provides buprenorphine (sublingual tablets or film) and dispenses and/or administers as required in CLIN 4045. Total price is per drug cost and dispensing and/or administration.

5.4.3. MAT- Buprenorphine and Administration of Injection (CLIN 4031): When authorized, the Contractor provides injectable buprenorphine and administers, as required in CLIN 4045. Total price is per monthly drug cost and monthly administration.

5.4.4. MAT - Buprenorphine Implant and Removal (CLIN 4032): When authorized, the Contractor inserts and removes a buprenorphine implant. Total price is per drug cost, implant, and removal once every six (6) months.

5.4.5. MAT - Naltrexone and Administration of Injection (CLIN 4041): When authorized, the Contractor provides injectable naltrexone and administers as required in CLIN 4045. Total price is per monthly drug cost and monthly administration.

5.4.6. Administration of MAT Medication (CLIN 4045): Administer intramuscular or subcutaneous abdominal injections of naltrexone or buprenorphine and/or dispense oral or sublingual medications for an opioid use disorder. The Contractor performing any administration of medication must be qualified and

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licensed to do so in the state where services are rendered and must meet all existing regulations. Price is per administration only.

5.5. MAT - FOLLOW-UP AND REPORT: MAT follow-up is used to evaluate the efficacy of the specific medication prescribed for the treatment of an opioid or alcohol use disorder, order medical and laboratory testing (if needed) and monitor test results, order urine drug screenings (as needed) or review urine drug screenings (if made available), and make changes to the treatment regimen, when deemed clinically appropriate. The Contractor shall provide, as clinically indicated, regular on-going follow-up assessments and dosage adjustments, either in person or by telehealth.

Keeping with the no “one size fits all” approach to OUD treatment, the Contractor shall also utilize follow-up sessions to develop an individualized treatment plan for each client based on that client’s needs, goals, the availability of treatment, and the client’s willingness to comply with the expectations of treatment with medications for OUD. The frequency of follow-up sessions will vary depending on the medication being prescribed, the phase of treatment and the client’s diagnosis, as determined during the initial evaluation.

During initiation of buprenorphine with opioid dependent clients, it is expected that frequent contact with the client will occur. After a client has completed the stabilization phase for buprenorphine, it is recommended that clients are seen at least once weekly to ensure adherence to medication, to assess the client’s clinical needs, medication effectiveness, medication side effects, and to ensure adequate therapeutic dosing.

When a client has demonstrated compliance and is on a therapeutic dose, less frequent visits may be needed. At a minimum, the Contractor must provide one monthly follow-up with the client during the maintenance phase once a c l i e n t has gone several weeks of abstinence from opioids, demonstrated compliance with medication, had an absence of medication side effects, and exhibited mental health stability. For clients with extended placements in the community, the Contractor shall schedule follow-up services as clinically appropriate, e.g., at least quarterly during the first year of maintenance treatment in the community, with adjustments to scheduling made based on compliance with medication and continued abstinence.

MAT follow-up services will not be reimbursed prior to receipt of the report. The Contractor must submit a MAT – Follow-up Report completed by the authorized practitioner(s) who provided the follow-up service, to include the date, service code, length of contact, and comments (e.g., adjustment, responsiveness, need for change in medication regimen, etc.) with the monthly invoice. Price is per report.

5.5.1. MAT – Follow-up and Report (CLIN 4004): MAT follow-up, delivered in person or by telehealth, is used to evaluate the efficacy of the buprenorphine or naltrexone prescribed for the treatment of an OUD or AUD, order necessary medical and laboratory testing and monitor test results, order urine drug

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screenings or review UDS (if made available), and make changes to the treatment regimen, when deemed clinically appropriate. The Contractor shall ensure the medication used for MAT services is prescribed in compliance with all existing regulations and in a manner specified by the FDA. MAT Follow-up services will not be paid prior to receipt of the report. Price is per report.

5.6. MAT – TERMINATION REPORT. The Termination Report document summarizes the client’s course of MAT services and prognosis. The Contractor shall complete and forward the MAT Termination Report to CTS and to the receiving U.S. Probation Office ten (10) business days prior to a client’s projected end date. When treatment is abruptly terminated (withdrawal or removal), the termination report must be sent within ten (10) business days of notification.

5.7. TREATMENT DOCUMENTATION. All treatment documents are provided by the

Bureau. Contractors must thoroughly complete and submit all documents to the Bureau’s electronic file management system (EFMS). Contractors must use the most recent version of documents provided by the Bureau. When documents are updated, the Contractor shall implement use within twenty (20) business days.

Contractors may request to use compatible internal documents if they satisfy all requirements of those provided by the Bureau. Contractors may not use internal documents until they receive written authorization from the FAC COR. This authorization may be rescinded at any time with a twenty (20) business day notice.

If a document for a specific service is not provided by the Bureau, the Contractor may, by default, use a compatible internal document that satisfies all requirements specified herein.

5.7.1. Electronic File Management System (EFMS). The Contractor shall utilize the Bureau approved electronic system for the primary receipt of referrals and transmission of all treatment documents and notes. This system is a FISMA moderate system that meets NIST 800-53 security controls.

5.7.2. Documentation Requirements. All treatment documentation must be submitted to the EFMS and must be completed and signed by the Contractor who provided the service. Generic content, templates, and general clinical themes do not constitute acceptable documentation of progress in treatment.

Documentation that does not meet these standards will be returned for correction which may result in delay of payment until acceptable documentation is received.

5.7.3. Electronic Signatures. The Contractor shall provide legally acceptable signatures on all documentation in accordance with state and federal law.

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Signatures that are authenticated by the user, such as digital signature certificates or signature images, are acceptable. Typed signatures that are easily added by any staff, such as cursive script, are not acceptable as an electronic signature.

Proof of signature authentication shall be provided to the FAC COR upon request.

5.8. INVOICE AND PAYMENT. The Contractor shall account for all MAT services rendered pursuant to this SOW and submit an invoice on a monthly basis.

5.8.1. Billing. Services rendered must be billed monthly on the Bureau issued invoice per client, in accordance with the Pricing Schedule (see Standard Form 1449, Block 20).

5.8.1.1. The Contractor must have a method in place to accept electronic payment for monthly billing.

5.8.1.2. Each option year, it is the responsibility of the Contractor to verify and update prices in accordance with the Pricing Schedule.

5.8.2. Invoice. The Contractor must submit a standard invoice for payment processing to the Bureau. The FAR 52.212-4(g) states the following must be included in all invoice submissions: name and address; contract number and contract line item numbers (CLIN); description and quantity of items; dates of services; name, title, and phone number of whom to notify of invoice errors; and Taxpayer Identification Number (TIN).

5.8.2.1. All invoices shall be completed accurately in its entirety. Invoices lacking the appropriate information or containing errors will be returned to the Contractor for correction which may result in a delay of payment. All invoices must be signed and dated prior to submission.

5.8.2.2. All invoices must be submitted to the Bureau on or before the 20th of each month.

5.8.2.3. Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

5.9. SUMMARY OF CONTRACT LINE ITEM NUMBER (CLIN) PRICING.

Evaluations and Reports:

CLIN Unit Type Unit Billed 4005 MAT Intake Screening 1 unit per declined informed consent 4050 MAT Psychiatric Evaluation & Report 1 unit per report 4054 TeleMAT Psychiatric Evaluation & Report 1 unit per report

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Medication and Follow-Up Services:

CLIN Unit Type Unit Billed 4000 MAT – OTP Services 1 unit per day 4004 MAT – Follow-Up and Report 1 unit per report 4021 MAT – Buprenorphine and Administration 1 unit per administration 4031 MAT – Buprenorphine and Administration of Injection 1 unit per administration 4032 MAT – Buprenorphine Implant and Removal 1 unit per administration 4041 MAT – Naltrexone and Administration of Injection 1 unit per administration 4045 MAT – Administration of Medication 1 unit per administration

5.10. DELIVERABLES.

All deliverables shall be submitted in accordance with the referenced SOW requirement:

SOW

Section Deliverable Description Estimated Quantity Due Date

5.2 Initial Contact 1 per tx authorization Within 2 (two) business days from tx authorization date

5.2.1 MAT Intake Screening 1 per declined

informed consent

Within 1 (one) business day of initial contact

5.3.1 MAT Psychiatric

Evaluation & Report

1 evaluation per client Within 10 (ten) business days of initial contact

1 report per client Within 5 (five) business days of evaluation

5.3.2 TeleMAT Psychiatric

Evaluation & Report

1 evaluation per client Within 10 (ten) business days of initial contact

1 report per client Within 5 (five) business days of evaluation

5.5.1 MAT – Follow-Up

Service

As clinically indicated per section 5.5

Due with monthly invoice

MAT – Follow-Up Report

1 per client per month

5.6 Termination Report 1 report per client Within 10 (ten) business days prior to tx end date or within 10 (ten) days of notification

5.8.2.2 Invoices 1 per month Due on or before 20th

6.9.2 Behavior Notifications As indicated per section

6.9.2 No later than 24 hours of reportable

behavior

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CHAPTER SIX: ADMINISTRATION

6.1. FACILITY LICENSURE/CERTIFICATION. The Contractor must provide medication-assisted treatment in an opioid treatment program (OTP) that is both certified and accredited; licensed by the state in which they operate; and registered with the local DEA office.