Statement of Work TeleMAT.pdf

COMMUNITY TREATMENT SERVICES

(CTS)

MEDICATION-ASSISTED

TREATMENT (MAT)

FEBRUARY 2022

Community Treatment Services | MAT SOW| February 2022 1

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) to offenders in the custody of the Bureau of Prisons (Bureau), residing in a Residential Reentry Center (RRC), on Home Confinement (HC), or on Federal Location Monitoring (FLM).

1.1.1 Scope. The scope includes community substance use disorder treatment for Bureau inmates with an alcohol use disorder (AUD) or an opioid use disorder (OUD) 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.

1.1.2 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 incarcerated individuals meet the criteria for a substance use disorder, with up to one-quarter of offenders having an OUD. Medication-assisted treatment (MAT) is an important part of treating offenders with an alcohol use or opioid use disorder. When monitored and properly used, MAT is an effective, safe, and cost-effective treatment.

In November 2018, the Bureau established a MAT Program for offenders with an OUD who were returning to the community. Utilizing naltrexone (Vivitrol) as the initial

Community Treatment Services | MAT SOW| February 2022 2 medication for treatment, the Bureau began the naltrexone program in the Northeast Region.

In February 2019, as required by the First Step Act, the Bureau implemented a 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. Offenders 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 offenders 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. Offenders receive a medication regimen and participate in evidence-based counseling.

2.2.1 Institution MAT Participants. Offenders 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 offenders 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. Offenders who are active in MAT while incarcerated are referred by CTS to continue while in the community. Additionally, any offender 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 medications, in combination with counseling and behavioral therapies, for the treatment of substance use disorders, as well as to sustain recovery and prevent overdose. MAT operates to stabilize brain chemistry, block the euphoric effects of opioids, relieve physiological cravings, and stabilize body functions without the negative effects of the short-acting drugs of abuse.

Medications used in MAT are approved by the Food and Drug Administration (FDA) and treatment is clinically driven and tailored to an individual’s needs.

Behavioral therapy is an effective treatment for substance use disorders, and in combination with medications for AUD and OUD, is associated with improved outcomes.

Evidence-based models that are effective in treating substance use disorders focus on an individual’s thoughts, beliefs, and behaviors. Participation in Cognitive Behavioral Therapy, Motivational Interviewing, Rational Emotive Behavior Therapy, or Mindfulness

Community Treatment Services | MAT SOW| February 2022 3

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 42.CFR 8.12, MAT clients receiving treatment in an opioid treatment program (OTP) must receive counseling, which may include different forms of behavioral therapy. These services are required along with medical, vocational, educational, and other assessment and treatment services.

3.1.1 MAT Medications. The FDA has approved several different medications to treat alcohol and opioid use disorders. MAT medications relieve the withdrawal symptoms and psychological cravings that cause chemical imbalances in the body. Medications used for MAT are evidence-based treatment options and do not just substitute one drug for another.

OUD medications reduce illicit opioid use, retain people in treatment, and reduce risk of opioid overdose death better than treatment with placebo or no medication. Products approved by the FDA for treating OUD include methadone, buprenorphine or buprenorphine with naloxone, and naltrexone.

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.

3.1.2 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).

3.1.3 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, 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 on a monthly basis. 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.

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=3&SID=7282616ac574225f795d5849935efc45&ty=HTML&h=L&n=pt42.1.8&r=PART#se42.1.8_112

Community Treatment Services | MAT SOW| February 2022 4

3.1.4 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.

3.2 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).

3.2.1 Opioid Treatment Program (OTPs). Title 42 of the Code of Federal Regulations

Part 8 (42 CFR § 8) sets the standards for opioid treatment programs (OTPs). Under these federal regulations, OTPs are 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. OTPs 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.

3.2.2 Office-Based Opioid Treatment (OBOT). Office-based opioid treatment (OBOT) are outpatient treatment services provided outside of licensed Opioid Treatment Programs (OTPs). The Comprehensive Addiction and Recovery Act (CARA), the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT) Act, and Drug Addiction Treatment Act of 2000 (DATA 2000) allows qualified practitioners to dispense or prescribe buprenorphine for the treatment of opioid use disorders (OUD) in an office based setting, upon completion of specialized training. 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.

3.3 MAT State and Federal Regulations. Federal and state laws and other policies may affect the prescribing and dispensing of medications for opioid 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 their respective states; however, additional rules and regulations apply to methadone and buprenorphine because of their status as controlled https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#CARA https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#DATA-2000 https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#DATA-2000

Community Treatment Services | MAT SOW| February 2022 5 substances under the Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act, 1970).

Several states regulate the practices of physicians who offer OBOT to ensure an appropriate quality of care for clients receiving office-based opioid treatment and reduce the diversion of buprenorphine. The regulations vary by state, but generally involve a licensing requirement and associated inspections and fees, and may include requirements related to staff training, types of services offered, and/or limits on buprenorphine dosages and formulations.

3.3.1 The Comprehensive Addiction and Recovery Act of 2016 (CARA). CARA amended the Controlled Substances Act to allow qualifying nurse practitioners and physician assistants to receive a DATA 2000 waiver and prescribe buprenorphine at the original thirty (30) and one hundred (100) patient limits. However, several states have scope of practice laws that limit the effect of this federal law.

3.3.2 The Substance Use Disorder Prevention that Promotes Opioid Recovery and

Treatment for Patients and Communities Act of 2018 (SUPPORT) Act.

The SUPPORT Act affords practitioners greater flexibility in the provision of MAT and extends the privilege of prescribing buprenorphine in office-based settings to qualifying other practitioners (Nurse Practitioners (NPs), Physician Assistants (PAs), Clinical Nurse Specialists (CNSs), Certified Registered Nurse Anesthetist (CRNAs), and Certified Nurse-Midwifes (CNMs) until October 1, 2023.

3.3.3 Drug Addiction Treatment Act of 2000 (DATA 2000). DATA 2000, part of the Children’s Health Act of 2000, permits practitioners who meet certain qualifications to treat opioid dependency with narcotic medications approved by the FDA, including buprenorphine, in treatment settings other than an opioid treatment program. Pursuant to the Drug Addiction Treatment Act of 2000 (DATA 2000), qualified practitioners can prescribe buprenorphine to patients for the treatment of opioid use disorder after completing a required training and submitting to SAMHSA a notification of intent to prescribe.

3.3.4 Patient Limits for Buprenorphine. Practitioners are limited to treating no more than thirty (30), one hundred (100), or two hundred seventy-five (275) patients at any one time, depending on certain conditions being satisfied for statutory certification requirements relative to training and psychosocial services. Patient limits are cumulative, not per location or DEA number.

3.3.5 Buprenorphine Waivered Practitioner. To obtain a waiver to administer, dispense, and prescribe buprenorphine, practitioners must notify SAMHSA’s Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT) of their intent to practice this form of medication-assisted treatment. This waiver, commonly known as the X-waiver, is the practitioner’s DEA number with the first letter replaced with an “X”. A practitioner may have only one X-waiver as the waiver is attached to only one DEA number. The X-waiver is valid in all US states and https://www.congress.gov/bill/115th-congress/house-bill/6

Community Treatment Services | MAT SOW| February 2022 6 territories. The practitioner may have multiple practice locations or DEA numbers and be in any US state or territory. To use the waiver with another DEA number, practitioners must submit both the X-waiver number along with the other DEA number to prescribe.

3.3.6 April 2021 Buprenorphine Practice Guideline Update. Per the Department of

Health and Human Services (DHHS), The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder now provides an exemption from certain certification requirements under 21U.S.C.§823(g)(2)(B)(i)-(ii) of the Controlled Substances Act (DHHS, 2021). The updates specified that practitioners who are licensed under state law and who possess a valid DEA registration may be exempt from the certification requirements related to training, counseling, and other ancillary services.

Practitioners who have a DEA registration are permitted to apply for an X-waiver to treat up to 30 patients without completing the training course(s) or attesting to the provision of psychosocial treatment or counseling. Practitioners utilizing the exemption are limited to treating no more than 30 patients at any one time and time spent practicing under the exemption will not qualify the provider for a higher patient limit.

3.3.7 Ryan Haight Online Pharmacy Consumer Protection Act of 2008. The act significantly limited 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 patient and the prescription was signed for a specific medical purpose.

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. For clients treated with methadone at OTPs, the in-person physical examination still applies.

These policies allow prescription of controlled substances without first conducting an in-person examination if all of the following conditions are 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.

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

Community Treatment Services | MAT SOW| February 2022 7

When the emergency declaration expires or is revoked, this suspension of the requirements could lapse, if no further action is taken by the DEA or SAMHSA to extend them.

CHAPTER FOUR: GUIDANCE ON PROVIDING MAT FOR COMMUNITY

TREATMENT SERVICES

4 D

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 all MAT services in-person or by video or audio-only telehealth. Providing MAT services by telehealth is dependent on the type of drug being utilized, per federal law. States 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 OTP 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.

4.1.3 OBOT. The Contractor must have DATA 2000-waivered practitioners provide outpatient treatment services for OUD. The Contractor shall also comply with state regulations involving office-based opioid treatment (OBOT) licensing requirements, staff training, types of services offered, and/or limits on buprenorphine dosages and formulations as well as a minimum number of clients served.

4.1.4 Data 2000 Waivers. The Contractor shall maintain certified practitioners with a

DATA 2000 waiver identification number (X-number) and a DEA registration number to administer, prescribe, or dispense buprenorphine.

4.1.5 Record Keeping Requirements. The Contractor must keep records and inventories of all controlled substances dispensed, including approved buprenorphine products, under the Persons Required to Keep Records and File Reports, 21 Code of Federal Regulations (CFR) PART 1304.03.

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

Community Treatment Services | MAT SOW| February 2022 8

4.1.6 Diagnosis. The Contractor must determine and establish the appropriate diagnosis of

OUD for an offender receiving MAT services. The Contractor shall refer to the DSM- 5 for specific criteria and guidance.

4.1.7 DSM-5 Criteria. 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 offender’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 offender, based on current presentation:

• 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)

4.1.8 Urine Drug Testing (UDT). Drug monitoring should be used as a therapeutic tool to provide motivation and reinforcement for abstinence, as well as to confirm medications for OUD. The Contractor shall utilize UDT to monitor offenders for adherence to medication and for the use of illicit and controlled substances.

4.1.9 Frequency of Urine Drug Testing. The Contractor shall require eight (8) urine drug tests, at a minimum, per year for offenders on maintenance treatment with methadone or buprenorphine, pursuant to the Code of Federal Regulations for OTPs.

For OBOT settings in which offenders are being treated with buprenorphine by DATA- 2000 waivered practitioners, there are no mandatory UDT requirements. The Contractor must use clinical judgement to determine the frequency of drug testing, Community Treatment Services | MAT SOW| February 2022 9 based on the phase of buprenorphine treatment, offender compliance, and for diversion control. Ordinarily, the Contractor shall require a UDT at the time of the initial evaluation and regularly during the initiation of treatment with buprenorphine. The Contractor shall conduct at least quarterly UDTs, with more as clinically indicated, for offenders on maintenance treatment with buprenorphine.

4.1.10 Correctional UDTs. Offenders participating in CTS are drug tested no less than four times a month while in community placement for correctional reasons. If made available and useful information is provided, the Contractor may utilize the correctional UDTs and review the data for drug monitoring.

4.1.11 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 offender the PDMP will be accessed to monitor their controlled prescription drug use.

4.1.12 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 offenders on safe storage of, and non-sharing of medications; counsel offenders 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 offender’s needs; and ensure offender understands treatment agreement and prescription policies.

4.1.13 Telehealth. Telehealth services for MAT (TeleMAT) may include audio only or audio/video technology. Contractor must use telehealth to provide all TeleMAT services. Contractor must adhere to all federal and state requirements for maintaining privacy, protection, and secure handling of all Protected Health Information (PHI).

4.1.13.1 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, 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 your own HIPAA-compliant device or electronic record keeping system, in order to safeguard any electronic protected health information or PHI.

4.1.13.2 Contractor shall provide information to offenders on how to access any digital platform that may be used in the delivery of telehealth services, to

Community Treatment Services | MAT SOW| February 2022 10 include navigating in the virtual platform, how to download the mobile application or how to use their device — whether it’s a smartphone, laptop, tablet — to participate in MAT sessions.

4.1.14 Informed Consent. The Contractor shall advise offenders of the risks and benefits of the treatments available, to include MAT and non-MAT alternatives, and should also explain the offender’s 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 offender.

4.1.15 Verifying Identity. The Contractor must verify the identity of the offender prior to each MAT session, whether in-person or by telehealth, by confirming the offender’s name, date of birth, and register number.

4.1.16 Individualized Treatment. There is no “one size fits all” treatment for offenders with an opioid use disorder. MAT provides a “whole-person” approach by combining medications with counseling and behavioral therapy. The Contractor must individualize treatment according to the needs of the offender by providing access to the most clinically appropriate and available FDA-approved medication to treat OUD and integrating evidence-based counseling/therapy into an offender’s MAT program.

4.1.17 Evidence-Based Behavioral Counseling/Therapy. A critical element of MAT is participation in behavioral treatment to modify attitudes and behaviors related to substance use and to increase healthy life skills. Offenders receiving MAT for OUD are at increased risk for relapse to opioid use and interventions should target reducing relapse risk factors. The Contractor shall incorporate, but is not required to provide, behavioral counseling in an offender’s MAT program, e.g., cognitive-behavioral therapies, relapse prevention, and motivational interviewing. The Contractor shall only provide behavioral counseling sessions as authorized on the Treatment Referral and Authorization.

CHAPTER FIVE: SCOPE OF TREATMENT SERVICES

5.1. TREATMENT REFERRAL AND AUTHORIZATION. The Bureau will provide a Treatment Referral and Authorization form for each offender referred for MAT services. It will specify the authorized MAT services and service authorization period. 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 by contacting the Bureau. The FAC COR must preauthorize changes to the treatment regimen, including discontinuing treatment.

Community Treatment Services | MAT SOW| February 2022 11

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 offender 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 ten (10) business days from the treatment authorization start date (indicated on the Treatment Referral and Authorization), the Contractor must make contact with the referred offender for an initial evaluation session. The initial session shall include introductory information to the offender, completion of Bureau forms, informed consent, treatment agreement (if applicable), and a diagnostic interview and medical evaluation. The Contractor shall bill this session, based upon the specific MAT Psychiatric Evaluation conducted.

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 offender. All reports must be submitted to the Bureau as soon as completed, but no more than the timeframes specified below. Services may not be billed until the report is received by the Bureau.

5.3.1. MAT Psychiatric Evaluation and Report (CLIN 4050): An initial comprehensive diagnostic interview and medical assessment, including toxicology tests, other laboratory results, and psychosocial assessment. The report must provide a diagnosis, any co-occurring mental health disorders, as well as offender’s physical ability to participate in MAT. Reports must be sent to the Bureau within ten (10) business days of evaluation. Evaluation services will not be reimbursed prior to receipt of the report.

Price is per report.

5.3.2. MAT - Methadone Psychiatric Evaluation and Report (CLIN 4051): An initial comprehensive diagnostic interview and medical assessment, including toxicology tests, other laboratory results, and psychosocial assessment provided by an OTP for the provision of MAT services utilizing methadone. The report must provide a diagnosis, any co-occurring mental health disorders, as well as offender’s physical ability to participate in MAT. Reports must be sent to the Bureau within ten (10) business days

5.3.3. TeleMAT - Buprenorphine Psychiatric Evaluation and Report (CLIN 4052): An initial comprehensive diagnostic interview and medical assessment, including toxicology tests, other laboratory results, and psychosocial assessment conducted by telehealth for the provision of MAT services utilizing buprenorphine. The report must provide a diagnosis, any co-occurring mental health disorders, as well as offender’s physical ability to participate in MAT. Evaluation and assessment must be conducted by telehealth only. Reports must be sent to the Bureau within ten (10) business days

Community Treatment Services | MAT SOW| February 2022 12

5.3.4. TeleMAT – Naltrexone Psychiatric Evaluation and Report (CLIN 4053): An initial comprehensive diagnostic interview and medical assessment, including toxicology tests, other laboratory results, and psychosocial assessment conducted by telehealth for the provision of MAT services utilizing naltrexone. The report must provide a diagnosis, any co-occurring mental health disorders, as well as offender’s physical ability to participate in MAT. Evaluation and assessment must be conducted by telehealth only. Reports must be sent to the Bureau within ten (10) business days of evaluation. Evaluation services will not be reimbursed prior to receipt of the report.

5.4. MEDICATION SERVICES. Medication services include administration and/or dispensing of an FDA approved medication by an OTP or an OBOT by a qualified practitioner to treat an alcohol use or opioid use disorder and the medication, if authorized on the contract.

5.4.1. MAT - Administration of Methadone (CLIN 4010): Methadone is typically given in liquid form as a daily dose taken under observation. Services for MAT which prescribe methadone for an opioid use disorder are only billable when dispensed by an OTP licensed by the state and certified by SAMHSA, in accordance with state and federal regulations. Price is per daily administration and/or dispensing.

5.4.2. MAT - Methadone and Administration (CLIN 4011): When authorized, the Contractor provides methadone and dispenses and/or administers, as required in CLIN 4010. Total price is per daily drug cost and daily dispensing and/or administration.

5.4.3. MAT - Administration of Buprenorphine (CLIN 4020): Buprenorphine can be dispensed in an OTP or an OBOT by a qualified practitioner. Buprenorphine can be administered or dispensed as sublingual tablets or as a sublingual film, and is almost always combined with naloxone to deter abuse. Price is per administration and/or dispensing.

5.4.4. MAT - Buprenorphine and Administration (CLIN 4021): When authorized, the

Contractor provides buprenorphine (sublingual tablets or film, up to and including the daily recommended dosage) and dispenses and/or administers as required in CLIN 4020. Total price is per drug cost and dispensing and/or administration.

5.4.5. MAT - Administration of Buprenorphine Injection (CLIN 4030): Buprenorphine, as a subcutaneous abdominal injection, can be administered in an OTP or OBOT by a qualified practitioner. Price is per monthly administration.

5.4.6. MAT - Buprenorphine and Administration of Injection (CLIN 4031): When authorized, the Contractor provides injectable buprenorphine and administers, as required in CLIN 4030. Total price is per monthly drug cost and monthly administration.

Community Treatment Services | MAT SOW| February 2022 13

5.4.7. 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 months.

5.4.8. MAT - Administration of Naltrexone Injection (CLIN 4040): Naltrexone is usually delivered in the form of a monthly injection by a qualified practitioner. Individuals can receive naltrexone in many settings, including doctors’ offices, OTPs, and other clinical settings. Price is per monthly administration.

5.4.9. MAT - Naltrexone and Administration of Injection (CLIN 4041): When authorized, the Contractor provides injectable naltrexone and administers as required in CLIN 4040. Total price is per monthly drug cost and monthly administration.

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 alcohol or opioid use disorder, order and perform laboratory testing, monitor laboratory test results, 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.

5.5.1. At a minimum, the Contractor must provide one monthly follow-up with the offender during the maintenance phase. During early stabilization, the Contractor shall schedule follow-up services as clinically appropriate.

5.5.2. 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.

5.5.2.1. MAT - Methadone Follow-up and Report (CLIN 4001): The Contractor shall evaluate the efficacy of the use of methadone, incorporating feedback from a clinical practitioner, if applicable, and the offender.

5.5.2.2. MAT - Buprenorphine Follow-up and Report (CLIN 4002): The

Contractor shall evaluate the efficacy of the use of buprenorphine, incorporating feedback from a clinical practitioner, if applicable, and the offender.

5.5.2.3. MAT - Naltrexone Follow-up and Report (CLIN 4003): The Contractor shall evaluate the efficacy of the use of naltrexone, incorporating feedback from a clinical practitioner, if applicable, and the offender.

5.5.2.4. TeleMAT - Buprenorphine Follow-up and Report (CLIN 4004): The

Contractor shall evaluate the efficacy of the use of buprenorphine, Community Treatment Services | MAT SOW| February 2022 14 incorporating feedback from a clinical practitioner, if applicable, and the offender. Follow-up service must be conducted by telehealth only.

5.5.2.5. TeleMAT – Naltrexone Follow-up and Report (CLIN 4005): The Contractor shall evaluate the efficacy of the use of naltrexone, incorporating feedback from a clinical practitioner, if applicable, and the offender.

Follow-up service must be conducted by telehealth only.

5.6. MAT – TERMINATION REPORT. The Termination Report document summarizes the offender’s course of MAT services and prognosis. The Contractor shall complete a MAT

- Termination Report upon an offender’s successful completion, withdrawal, or removal from MAT, up to and including release from Bureau custody. The Termination Report must be completed and forwarded to the Bureau within ten business days from termination of treatment.

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

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

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

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

5.7.2. 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;

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).

5.7.2.1. 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.

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

5.7.2.3. 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.

Community Treatment Services | MAT SOW| February 2022 15

5.8. SUMMARY OF CONTRACT LINE ITEM PRICING.

Evaluations and Reports:

CLIN Unit Type Unit Billed 4050 MAT Psychiatric Evaluation & Report 1 unit per report

Medication and Follow-Up Services:

CLIN Unit Type Unit Billed 4001 MAT – Methadone Follow-Up and Report 1 unit per report 4002 MAT – Buprenorphine Follow-Up and Report 1 unit per report 4003 MAT – Naltrexone Follow-Up and Report 1 unit per report 4010 MAT – Administration of Methadone 1 unit per administration 4011 MAT – Methadone and Administration 1 unit per administration 4020 MAT – Administration of Buprenorphine 1 unit per administration 4021 MAT – Buprenorphine and Administration 1 unit per administration 4030 MAT – Administration of Buprenorphine Injection 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 4040 MAT – Administration of Naltrexone Injection 1 unit per administration 4041 MAT – Naltrexone and Administration of Injection 1 unit per administration

CHAPTER SIX: CONTRACTOR PERSONNEL

6.1. QUALIFIED PERSONNEL. Contractor shall provide qualified personnel to perform all requirements specified in this SOW. Contractor shall identify by name, position, and responsibility key personnel who meet SOW and the initial Decisional Rule Criteria (DRC) requirements from the contract solicitation to provide MAT services awarded to the contract

6.2. Key Personnel. Contractor shall maintain key personnel for the life of the contract and inform the Bureau of any changes. The Contractor shall not replace key personnel without approval from the Bureau. All personnel providing MAT services must meet the licensure/certification standards as listed in the Decisional Rule Criteria (Section 2.1 of SF 1449).

6.2.1. Contractor shall verify the education, experience, training, and credentials of key personnel. The Contractor shall voucher potential employees through reference and employment checks and document information regarding reference and employment checks.

Community Treatment Services | MAT SOW| February 2022 16

6.3. MAT Providers. The Contractor must have a qualified practitioner (e.g., Medical Doctor, Psychiatrist, Physician Assistant, Advanced Practice Registered Nurse Practitioner/Specialist) with prescriptive authority (DEA Registration Certificate, X-waiver) who meets the standards of practice established by the applicable state’s professional regulatory board to provide MAT evaluations, medication services, and follow-up services in the state where services will be rendered.

6.4. Approvals. The Bureau requires that all contract staff (employees and subcontractors) both administrative and key personnel are approved in writing by the Bureau prior to any contact with offenders. The Contractor must only submit approval requests for personnel who will actively participate in the administration of the contract.

6.4.1. All proposed personnel on the initial Technical Personnel document who meet the solicitation requirements must be submitted for approval. Prior or current approvals from other contracts do not substitute for this process. Ordinarily, the initial background check process for proposed personnel is completed when the Contractor becomes the apparent awardee. The Authorized Negotiator is responsible for ensuring timely submission of all requested information and documentation for the background checks to avoid delays of contract award.

6.4.2. After the Contractor determines that personnel is appropriate to work with offenders, the Contractor will request a background check from the Bureau. The Contractor will submit all relevant information, including a completed and signed NCIC Check form and copy of the individual’s driver’s license. This begins the background check process. The information provided on the form includes full name, all aliases used, date of birth, place of birth, sex, race, and social security number. The Contractor shall notify the individual that a National Crime Information Center/National Law Enforcement Telecommunication System (NCIC/NLETS), criminal records and other appropriate background checks will be processed by the Bureau to verify this information.

6.4.3. Contractor shall not submit anyone for Bureau approval who is under the supervision or jurisdiction of any parole, probation, or correctional authority. Contract staff with previous criminal convictions, who are not under supervision, may be considered for approval to work with offenders referred for MAT services. However, the Bureau reserves the right of approval in such cases. Consideration will be given to such factors as criminal history, time elapsed since conviction(s), and subsequent adjustment in the community.

6.4.4. Contract staff shall not begin working with offenders prior to obtaining written approval from the Bureau. Approval may be granted after the NCIC/NLETS check is complete with satisfactory results. Prior approval on a previous Bureau contract does not extend to new contracts, nor does it guarantee that the individual will be approved again.

Community Treatment Services | MAT SOW| February 2022 17

6.4.5. There may be occasions when an individual submitted for approval is prohibited from working with offenders. If the Contractor wishes to appeal the decision, the prohibited staff member may submit a detailed description of criminal history and reasons why the individual should be approved to work with offenders. This information will be reviewed for a final decision. This determination does not preclude the Contractor from employing the staff member to work with non- Bureau clients.

6.4.6. The Bureau reserves the right to revoke the approval, which may include immediate removal from providing MAT services under the contract, for any key personnel or administrative staff member pending investigation of alleged misconduct. The Contractor shall report all pending investigations or sanctions involving personnel providing service under the contract with the Bureau.

6.5. EMPLOYEE CONDUCT. The Contract’s Code of Ethics for their respective licensure/certification shall be practiced, along with the Bureau’s standards of conduct and the Contractor's internal standards and expectations for their employee. If ethical concerns or practices are observed, they must be reported to the Bureau within one business day.

6.6. TRAINING. Contractor shall train personnel regarding SOW requirements. All approved staff must be adequately trained at contract award and on annual basis.

6.6.1. Contractor must provide training to all approved staff regarding SOW requirements prior to the contract effective date, or within 10 business days for contracts that begin immediately.

6.6.2. New staff must complete training on SOW requirements within 10 business days after Bureau approval to work with offenders under the contract.

CHAPTER SEVEN: CONTRACT AND CONTRACT MONITORING

7.1. FAC-COR. The Contracting Officer will appoint a Federal Acquisition Certification for

Contracting Officer’s Representative (FAC-COR) from the CTS section to act as a representative in monitoring specified aspects of the contractor performance.

7.1.1. The FAC-COR will oversee the performance of the contract and ensure compliance with the requirements of the SOW.

7.1.2. The FAC-COR will provide technical assistance within the scope of the contract.

7.1.3. The FAC-COR will monitor and evaluate whether the Contractor meets the technical requirements under the contract within the period of performance. A monitoring summary letter will be completed that details the performance of the contract and any deficiencies which require corrective action. The Contractor must acknowledge receipt of the monitoring letter.

Community Treatment Services | MAT SOW| February 2022 18

7.1.4. Contractor must respond to all deficiencies with a Corrective Action Plan within 15 business days of written notification. The FAC-COR will inform the Contractor in writing when the Corrective Action Plan is accepted and the monitoring is closed. Plans will be closely monitored for sustained compliance. Failure to comply with accepted corrective action plans will result in a repeat deficiency.

7.1.5. The FAC-COR will provide documentation to the Contracting Officer of Contractor’s ability to provide MAT services that meet contractual requirements. The information submitted will be entered into the Contractor Performance and Assessment Reporting System (CPARS).

7.1.6. The web-based CPARS system is used to provide contractor performance evaluations.

The Contractor may submit information to the FAC-COR that could be considered for the CPARS report. Contractor shall provide and maintain a valid email address throughout the life of the contract.