Infectious Diseases Associated with Opioid Use (C6220)

Memorandum of Agreement Terms and Conditions Exemption (501c3) (PON2) This Memorandum of Agreement (MOA) between the Commonwealth of Kentucky, Cabinet for Health and Family Services, Department for Behavioral Health, Developmental and Intellectual Disabilities (“the Commonwealth”) and University of Kentucky Research Foundation / University of Kentucky Healthcare (UKHC) Infectious Diseases Division (UKID) (‘the Contractor”) is to establish an agreement to increase access to medications for opioid use disorder (MOUD) and wrap around services for individuals with injection-drug related infectious diseases. The initial MOA is effective from 7/1/2026 through 6/30/2027. SECTION 1 – ADMINISTRATIVE OVERVIEW 1.00 Purpose and Background DBHDID Guiding Principles The Kentucky Department for Behavioral Health, Developmental and Intellectual Disabilities (DBHDID) is committed to providing leadership and support to develop, implement, and sustain an effective service delivery system for Kentuckians with behavioral health needs and intellectual and developmental disabilities. Guided by a shared set of values, DBHDID’s mission is rooted in person-centered and culturally responsive care that promotes recovery, resiliency, inclusion, and self-determination. DBHDID strives to ensure that individuals and their families are full partners in planning, delivering, and evaluating services. This includes building natural supports, fostering inclusive community living and employment opportunities, and ensuring all practices are trauma-informed and equitable. The Kentucky Overdose Response Effort (KORE)—housed within DBHDID—is focused on expanding and sustaining a comprehensive, equitable, and recovery-oriented system of care to reduce overdose deaths across the state. To achieve this aim, KORE and its partners commit to implementing a trauma- and resilience-informed care approach to address OUD and StimUD. KORE aims to increase equitable access to evidence-based and community-defined prevention, treatment, and recovery support services. Informed by data on populations most in need, KORE’s priority populations include, but are not limited to, individuals with OUD and/or StimUD who are: 1) Disproportionally impacted by the overdose epidemic; 2) Overdose survivors; 3) Criminal-legal system-involved; 4) Pregnant and postpartum; and 5) Transition- age youth. KORE is funded through the Substance Abuse and Mental Health Administration (SAMHSA) State Opioid Response grant mechanism. DBHDID funding is intended to serve as a payer of last resort. Contractors must ensure that all individuals receiving services have applied for other eligible funding sources, such as Medicaid or private insurance, before using DBHDID funds. Contractors are prohibited from using federal funds to purchase, prescribe, or provide marijuana or treatment using marijuana. See, e.g., 45 C.F.R. 75.300(a) (requiring HHS to ensure that Federal funding is expended in full accordance with U.S. statutory and public policy requirements); 21 U.S.C. 812(c)(10) and 841 (prohibiting the possession, manufacture, sale, purchase or distribution of marijuana). Contractors and subcontractors are prohibited from denying any eligible client, patient, or individual access to their program because of their use of FDA-approved MOUD (e.g., methadone, buprenorphine products including buprenorphine/naloxone combination formulations and buprenorphine monoproduct formulations, naltrexone products including extended-release injections, and oral formulations of naltrexone). Patients must be allowed to participate in methadone treatment rendered in accordance with current federal and state methadone dispensing regulations from an opioid treatment program and ordered by a physician who has evaluated the client and determined that methadone is an appropriate medication treatment for the individual’s OUD. Similarly, medications available by prescription must be permitted if a licensed prescriber or provider prescribes them. In all cases, MOUD must be permitted to be continued for as long as the prescriber determines that the medication is clinically beneficial. Contractors must assure that clients will not be compelled to no longer use medications for opioid use disorder as part of the conditions of any programming if stopping is inconsistent with a licensed prescriber’s recommendation or valid prescription. As such, a policy of mandatory medication taper for all clients after a fixed duration of time would preclude program eligibility. Medically managed withdrawal, when done in isolation, is not an evidence-based practice for OUD. Medically managed withdrawal services must be accompanied by the offer and provision of injectable extended-release naltrexone. Contractors are required to have a clearly defined process for determining service eligibility, notifying clients of their rights and appeal processes, and ensuring effective communication for individuals with hearing or language barriers. Contractors and their sub-recipients must promptly disclose in writing to DBHDID any known or suspected violations of federal criminal law involving fraud, bribery, or gratuities that could affect the use of federal- or state-funded awards. The Contractor will notify DBHDID prior to media communications and acknowledge federal and state funding in all communications activities using the following tag line: “This project is supported, in part, by the Kentucky Overdose Response Effort (KORE) through a Substance Abuse and Mental Health Services Administration (SAMHSA) Grant [1H79TI087770-01].” 1.01 Issuing Office The Commonwealth of Kentucky, Cabinet for Health and Family Services, Division of Procurement and Grant Oversight, is issuing this Contract on behalf of the Department for Behavioral Health, Developmental and Intellectual Disabilities. The Cabinet’s designee is the only office authorized to change, modify, amend, alter, or clarify the specifications, terms and conditions of this Contract. 1.02 Communications The Issuer identified on page 1 is the point of contact during the procurement process and for communications concerning contract issues during the life of the contract. After the Award of the Contract, all contractual communications are to be sent to the Agency Contact Person listed in the Extended Description of Commodity Line 1. Notices by the Cabinet shall be sent to the Contractor representative listed in the Extended Description of Commodity Line 1. Unless otherwise stated, all notices, consents, and other contractual communications shall be in writing. 1.03 Terminology For this Contract, the following terms may be used interchangeably: - Vendor: Contractor, Offeror, The Second Party, Proposer - Issuer of Contract: Buyer, Purchaser, Contract Officer - Commonwealth of Kentucky: Commonwealth, State - Cabinet for Health and Family Services: the Cabinet, the Department, the Agency, CHFS - Fiscal Year is the Commonwealth fiscal year: July 1 through June 30 - Biennium is the Commonwealth biennium: July 1 of each even numbered year through June 30 of the next even numbered year. 1.04 Organization This Contract is organized in the following manner: Section 1-Administrative Overview Section 2-Scope of Services Section 3-Pricing/Invoicing Section 4-CHFS General Terms and Conditions Section 5-Federal Requirements Finance Terms and Conditions of the Contract SECTION 2 – SCOPE OF SERVICES The University of Kentucky Research Foundation (UKRF) / University of Kentucky Healthcare (UKHC) Infectious Diseases Division (UKID) aims to increase access to medications for opioid use disorder (MOUD) and wrap-around services for individuals with injection drug-related infectious diseases. The program will be implemented within the Bluegrass Care Clinic (BCC), a UK-affiliated infectious diseases clinic. In recent years, UKID has observed a substantial rise in infections associated with injection drug use. UKID provides care to patients hospitalized at UKHC facilities and through outpatient services at the BCC. The BCC currently offers outpatient infectious disease care and comprehensive wrap-around services for people living with HIV across central and eastern Kentucky through Ryan White HIV/AIDS Program funding, which includes limited support for medications for opioid use disorder (MOUD). The proposed initiative will expand access to evidence-based substance use treatment services, including MOUD, to adults with opioid use disorder (OUD) and/or stimulant use disorder (StimUD) who receive UKID services for injection drug-related infections and are at elevated risk for HIV, Hepatitis B, or Hepatitis C. Leveraging the established wraparound care model, the BCC will implement the Infectious Diseases associated with Injection Drug Use and Wrap-Around Services (IDWAS) program to provide integrated, evidence-based treatment for substance use and infectious diseases, supported by a dedicated interdisciplinary team of providers and administrative staff. 2.00 Services Required UKHC/UKID shall provide the following programs/services: 1. Maintain team within the Infectious Diseases associated with Injection Drug Use and Wrap Around Service (IDWAS) program comprised of providers and administrative staff housed within the Bluegrass Care Clinic (BCC), a University of Kentucky-affiliated Infectious Diseases (UKID) Clinic. The treatment team shall include: a principal investigator, program director, ID physicians and addiction specialists, peer support specialist, medical case manager, patient services coordinator, and OPAT nurse. 2. Provide evidence-based substance use evaluations based on the ASAM 4th Edition criteria to determine referral pathways from UKHC and appropriate level of care. 3. Complete a comprehensive medical/social history and psychosocial needs assessment, provide overdose education (naloxone prescription, referral to syringe exchange programs, and safer injection practices), and assess MOUD readiness. 4. Provide treatment for infections associated with injection drug use as well as education and training to prevent the spread of HIV, Hepatitis, and other infections. An Outpatient Parenteral Antimicrobial Therapy (OPAT) nurse will perform in-clinic peripherally inserted central catheter (PICC) care, dressing changes, and blood draws in addition to coordinating outpatient care for patients with community-based providers as needed for OPAT care. 5. Provide clinical assessment and treatment of OUD, including FDA-approved MOUD (commercially available buprenorphine and naltrexone formulations). The inpatient addiction or ID teams will initiate MOUD while the patient is hospitalized, if possible, with follow-up in the BCC ID clinic within one (1) week of discharge. If MOUD is not initiated during hospitalization, the patient will receive instructions at discharge and be referred to the BCC for induction 24-72 hours later. The intake team will coordinate transportation if needed for the patient to attend follow up appointments. 6. Conduct screening and assessment for co-occurring substance use and mental health disorders for each patient and provide evidence-based treatment, including individual or group psychotherapy. 7. Ensure continuity of care and retain patients in treatment through partnerships with other UK MOUD provider groups, including the UK First Bridge Clinic, the UK SMART Clinic, and the UK PATHways Clinic. 8. Provide patients with additional community resources to increase patient retention in both addiction and infectious disease treatment by addressing barriers caused by lack of basic needs such as food, housing, transportation, and employment. 2.01 Deliverables UKHC / UKID shall provide or make available: 1. Training for IDWAS team members to implement MOUD services, including: a. Opportunities for the clinical team to be trained in best practices for treating individuals with infectious diseases related to injection drug use, including: i. Providing OUD treatment (including MOUD), ii. Providing trauma-informed care, and iii. Using the ASAM 4th Edition criteria to determine level of care, treatment plans, and referral needs. b. Meeting with all community collaborators for the IDWAS program and maintain a systemic process for referrals and follow-up care for enrolled participants receiving OUD treatment. d. Collaborating with Kentucky AIDS Education and Training Center to conduct booster session training (e.g., screening, brief intervention, and referral to treatment (SBIRT), Motivational Interviewing, multicultural competence) for necessary IDWAS. e. Retaining three (3) additional licensed physicians with MOUD training to ensure treatment capacity. Dr. Laura Fanucchi will assist with provider training and provide support for providers. 2. Access to MOUD for persons with OUD and injection drug-related infectious diseases by: a. Expanding the current MOUD referral process in BCC to include the UKID inpatient service. b. Partnering with other UKHC service lines (e.g., Hospital Medicine, Orthopedics, and Cardiology) to refer patients to IDWAS for MOUD. c. Implementing SBIRT for all patients on the UK ID service. d. Referring patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) OUD criteria to the IDWAS program for MOUD. e. Evaluating referred patients for inclusion criteria for MOUD and coordinating with inpatient Addiction Service to start MOUD during a hospital stay or referring to the IDWAS outpatient clinic for MOUD. f. Performing psychosocial needs assessment and intake visit during hospitalization via the IDWAS Medical Case Manager (MCM), Patient Services Coordinator (PSC), and Peer Support Specialist/Health Educator (PSS/HE). 3. Increased access to medical treatment for injection drug use-associated infections among patients with co-occurring OUD or Stimulant Use Disorder (StimUD), as evidenced by: a. Enrolling at least seventy (70) patients with co-occurring OUD/StimUD and injection drug use-associated infections (e.g., HIV, HCV, infective endocarditis) in the IDWAS program by June 30, 2027. b. Providing ongoing counseling and medical case management to support adherence to infectious disease and substance use treatment plans. c. Identifying and addressing barriers to care at each visit. d. Conducting intensive outpatient follow-up to ensure completion of both infectious disease and MOUD treatment. 4. Evidence-based interventions to reduce illicit substance use and misuse by: a. Prescribing FDA-approved medications for opioid use disorder (e.g., buprenorphine /naloxone formulations and injectable naltrexone) in collaboration with a pharmacist for medication review and education. b. Delivering MOUD and wrap-around services designed to increase motivation and engagement while reducing relapse risk and re-exposure to injection-related infections. 5. Overdose prevention education and life-saving interventions to promote safer drug use behaviors, including: a. Providing overdose prevention education and providing access to naloxone at each patient encounter. b. Screening at least ninety percent (90%) of new IDWAS patients with a history of injection drug use for overdose prevention needs and linking them to community services (e.g., syringe exchange, mental health care). c. Offering psychoeducation to support behavior change and decrease future risk factors related to OUD and infectious disease. 6. Wrap-around support services to enhance engagement and retention in care through: a. A Peer Support Specialist/Health Educator to assist patients in identifying and managing barriers to treatment participation. b. A Medical Case Manager to coordinate community-based supports that promote treatment stability and recovery. c. A Patient Services Coordinator to conduct outreach and follow-up for missed appointments and assist with re-engagement in care. d. An OPAT Nurse to coordinate outpatient parenteral antimicrobial therapy (PICC line care, dressing changes, lab draws) in collaboration with community providers such as home health, infusion centers, dialysis units, and other outpatient programs. 7. A process for continuous quality improvement (CQI) that: a. Uses client feedback and satisfaction data to improve services. b. Incorporates shared decision-making with clients and families. c. Implements at least one (1) data-driven activity annually to reduce service gaps. 8. A sustainability plan that includes regularly scheduled assessments of billing capacity for each provider and service type to support long-term service delivery. The sustainability plan shall be submitted to KORE by August 15th each year. 2.02 Reporting Requirements Collect and report client demographics and services rendered for all persons with OUD and/or stimulant use disorder enrolled in KORE-funded programs. Data shall be submitted, at a minimum, monthly by the 15th day following the reporting period to a DBHDID-approved data portal. Service providers complete the SAMHSA Unified Performance Reporting Tools–Administrative (SUPRT- A) instrument for individuals enrolled in KORE-funded programs. KORE-funded service recipients complete the SUPRT–Client or Caregiver (SUPRT-C) instrument. If applicable, submit quarterly reports on any trainings conducted as a part of KORE-funded activities. Reports shall be submitted by January 15th, April 15th, July 15th, and October 15th to [email protected]. Reports shall include, but not be limited to, the following information: a. Date of training; b. Type of training/Content focus; c. Number of individuals attending training; and d. Professional type for each trainee (physician, social worker, etc.). 2.03-Subcontractors xx SECTION 3 – PRICING/INVOICING Funding from this Agreement distributed through subsequent agreements with other entities shall not be issued as a “subrecipient” agreement or a subaward of federal financial assistance. An indirect rate of 10% has been approved and included in the budget. The contractor shall submit a monthly invoice for expense reimbursement, which shall include a detailed accounting of expenditures by activities, including personnel/fringe, travel, and other operating expenses. The current approved budget is attached to this contract (Attachment A), with understanding that individual line items within the budget are subject to change, as appropriate, but not to exceed the total contract amount of $________. Payment is conditioned upon receipt of appropriate, accurate, and timely invoices. For KORE-funded services, invoices for payment shall be submitted electronically to [email protected]. The Contractor shall submit monthly invoices. Invoices must be submitted no later than fifteen (45) calendar days after completion of the service period. The invoice must include at a minimum: 1. Vendor''s name and address. 2. PON2 number that invoice(s) are using for funding. 3. Clearly listed dates of service (from and to). 4. Date of Invoice (date invoice is prepared). 5. Total amount due for the current billing cycle. 6. Cumulative total for all invoices to date. 7. Detailed description of services provided. Invoices that do not contain the above requirements will be rejected and returned to the Contractor for re- invoicing.