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Home My WebLink AboutResolution - 2024-R0192 - MOU CON30606111, TTUHSC Managed Care, 340B Drug Pricing Program - 04/09/2024Resolution No. 2024-R0192 Item No. 6.34 Apri19, 2024 RESOLUTION BE IT RESOLV�D BY THE CITY COUNCIL OF TIIE CITY O� LUBBOCK: THAT the Mayor of the City of Lubbock is hereby authorized and directed to execute for and on behalf of the City of Lubbock, the Memorandum of Understanding (MOU), CON3606111, regarding eligibility and participation in the Health Resources and Services Administration's 340B Drug Pricing Program, by and between the City of Lubbock and "Texas Tech University Health Sciences Center (TTUHSC), on behalf of TTUHSC Managed Care, and all related documents. Said MOU is attached hercto and incorporated in this resolution as if fully set forth herein and shall be included in the minutes of the City Council. Passed by the City Council on _ ��32p�r# TRAY Y , YOR AT'�FST: Courtney Paz, City Secretary Al'pROVED AS TO CON'1 LNT: �!'� ---- Bill How on, Deputy Ci ager APPROVLD AS TO PORM: Rachael I'oster, ssistant City Attorney RES.MOU TTUHSC 340B Drug Pricing Program 3.27.24 Resolution No. 2024-R0192 City of Lubbock CON3606111 MEMORANDUM OF UNDERSTANDING This Memorandum of Understanding, (the "MOU"), is entered inta by and between the City of Lubbock, on behalf of its Health Deparhnent (primary grantee of Section 318 funds of the Public Health Service Act, hereafter, referred to as PRIMARY GRANTEE) and Texas Tech University Health Sciences Center, a public institution of higher education in the State of Texas, on behalf of T"TUHSC Managed Care (hereafter, referred to as the SUBRECIPIEN'1�, (collectively, the "Parties") in an effort to outline the relationship and set out the roles and responsibilities between the Parties regarding eligibility and participation in the Health Resources and Services Administration's (HRSA) 340B Drug Pricing Program (the "Program") and to ensure the coordination and implementation of strategies to support the scope of [PCHD NOFO (19-1901), Ending the HIV Epidemic (EHE) NOFO (20-2010), or other qualifying Section 318 grant]. RECITALS WHEREAS, the PRIMARY GRANTEE receives a direct grant from the CDC that uses funds from Section 318 of the Public Health Service Act to be provisioned in compliance with federal and state program regulations; and WHEREAS, the SUBRECIPIENT provides services consistent with the purpose of the Section 318 grant, including but not limited to: • procuring infectious disease medications through appropriate sources; • requiring all covered patients to be seen by providers managed by the Subrecipient; • providing patients appropriate education; • providing all patients residing within Subrecipient's domain of care appropriate infectious disease screening; and WHEREAS, the SUBRECIPIENT receives from the PRIMARY GRANTEE: • In-kind, non-cash contributions paid for by Section 3l 8 funds in the form of goods and services directly benefiting and specifically identifiable to the project or program; • Specimen processing and testing for syphilis; � Educational brochures; • Training to correctional facility staff on HIV and STI screening, treatment and care; • Partner services and linkage to care for individuals diagnosed with viral hepatitis, HN and STIs (recently released individuals or notifying partners of incarcerated individuals); • 340B medication(s) paid for by Section 318 funds and distributed through a HRSA-approved Combined Purchasing and Distribution Model. NOW THEREFORE in consideration of the mutual promises set forth herein and for other valuable consideration, the sufficiency of which is hereby acknowledged, the Parties agree as follows: I. Joint Resnonsibilities A. Ensure policies and procedures align with Program guidelines and expectations of compliance; B. Ensure all policies and procedures are implemented and adhered to; and For 340B Combined Purchasing and Distribution medications only: I IIIIII IIII� II II II�III III IIIIII IIIIIII I) III'll IIII IIII ( IIIII� IIIIII II II IIIIII III IIIIII IIIIIII II IIIII) IIII IIII ["'CON3806111 21 244241842304770599079278992387720895558782155025 1'7"'] rowareabyasc City of Lubbock CON3606111 C. Monitor and track medications from the Combined Purchasing and Distribution Program. II. PRIMARY GRANTEE Resoonsibilittes A. Attest to HRSA the eligibiliry of the SUBRECIPIENT to participate in the Program; B. Provide to the SUBRECIPIENT the federal grant number of the award or the Notice of Funding Opportunity (NOFO) number under which it is funded for registration in the Office of Pharmacy Affairs Information System (OPAIS) database; C. Review, approve, and monitor SUBRECIPIENT's registration in OPAIS; D. May review and approve the eligibility for each SUBRECIPIENT site to participate in the Program outlined in Attachment "A"; E. Provide education concerning Program compliance to SUBRECIPIENT through initial and ongoing technical assistance, including information on how to access the Apexus PVP Program, a HRSA contractor for further education; For 340B Combined Purchasing and Distribution medications only: F. Create, review, and update policies and procedures to ensure compliance with the Combined Purchasing and Distribution Program; G. Ensure all 340B medications provided to SUBRECIPIENT are through pre-authorized entities; and H. Monitor and support the SUBRECIPIENT on all compliance elements of the Program addressed in the policies and procedures outlined by the Combined Purchasing and Distribution Program. III. SUBRECIPIENT Resoonsibilities A. Determine eligibility of participation in the Program for each site listed in Attachment "A"; B. Register as a Covered Entity in OPAIS database, maintaining registration and annual recertification for all registered sites and associated pharmacies (if applicable) using the Section 318 grant number or NOFO number NH25PS005182 under which it receives funding or in-kind contributions from. The OPAIS database can be accessed at: https://340boQais.hrsa. ov/; C. On a continual basis, ensure all 3408 OPAIS information is accurate and up to date; D. Ensure program integriry by maintaining accurate records and documenting compliance with all Program requirements. To the extent authorized by the Constitution and the Iaws of the State of Texas, the SUBRECIPIENT will be liable and hold the PRIMARY GRANTEE harmless for any findings of noncompliance by the SUBRECIPIENT; (IIIII (IIIII II II IIIIII III IIIIII IIII'll II IIIIII IIII IIII ( IIIIII IIIIII II II IIIIII III IIIIII IIIIIII II IIIIII III) III) ["'CON38Q6111'21•244241842304770589079276992387720695558782155025'2'7"') Powm.eeyasc Ciry of Lubbock CON3606111 E. Ensure all 340B medications, laboratory, and/or other in-kind services provided under this MOU are used only for qualifying patients. It is the responsibility of the SUBRECIPIENT to prevent the diversion of 340B medications to ineligible patients. F. Report to HRSA and the PRIMARY GRANTEE how the SUBRECIPIENT will bill Medicaid fee-for- service drugs on the Medicaid Exclusion File, as mandated by 42 USC 256b(a)(5)(A)(i), to ensure compliance with the Duplicate Discount Prohibition requirements; G. If applicable, use 340B revenue to promote the purpose of the federal section 318 grant under which it is 340B eligible; H. Permit on-site or remoting audit and program monitoring visits by HRSA to ensure compliance with Program regulations; I. Notify the PRIMARY GRANTEE of any change in organizational policy relating to the distribution, storage, and dispensing of 340B medications, change in registration information, non-compliance, or discontinuation of participation in the program as soon as possible; For 340B Combined Purchasing and Distribution medications only: J. Obtain medications from authorized entity designated or approved by the PRIMARY GRANTEE; K. Distribute medications at no charge to eligible patients; L. Maintain records of each medication distributed to eligible patients. Records may be requested and audited by PRIMARY GRANTEE for onsite or remote monitoring at any time to ensure compliance. Records include, but are not limited to: billing records, medication tracking logs, and relevant patient records; M. Will not bill Medicaid or other payors for medications; N. Ensure medications are not sold or exchanged to any individual or entity; and O. Report waste or loss of inedications or any discovered non-compliance to the PRIMARY GRANTEE as soon as possible. IV. Term of the MOU This MOU begins upon the first date on which it has been executed by both Parties and ends one year thereafter. Upon expiration of the original term of this Agreement, this Agreement will continue in full force and effect on a year-to-year basis, not to exceed four, one-year renewals, unless terminated by either Party. V. Amendments Amendments to this MOU sha�l be in writing and signed by the Parties. PBge 3 Of 7 TTIIHSC I II'lll IIIIII II II (IIIII III IIIIII IIIIIII I) IIIII� IIII II�I I IIIIII IIIIII II II IIIIII III IIIIII IIIIII) I) III�II III) IIII [""CON3806111 21 244241842304770598079276992387720695556782155025 3'7 ] Pow�sanyasc City of Lubbock CON3606111 VI. Termination of MOU A. Termination by Mutual Agreement. Either Party may terminate this MOU, or any part thereof, at any time with written notice sixty days prior to the date of termination. Upon expiration of the sixty (60) day period, the SUBRECIPIENT shall notify HRSA and be removed from the 340B Program if otherwise ineligible to participate in the Program. B. Termination for Cause. This MOU may be terminated for a material breach upon sixty (60) days written notice of such alleged material breach. Such notice shall specify in reasonable detail the nature of the breach and the actions required to cure the breach if such is curable. Termination of this MOU and suspension from the 340B Program shall occur upon the expiration of said sixty (60) day period if the conditions to resolve the material breach cannot be met. VII. Additional Terms and Conditions A. Confidentiality Confidential Information: All Confidential Information (as defined below) shall be the property of the disclosing party. Each party agrees the receiving party shall (i) use at least the same degree of care to prevent unauthorized use and disclosure of disclosing party's Confidential Information as the receiving party uses concerning its own Confidential Information (but in no case less than a reasonable degree of care); (ii) use the disclosing party's Confidential Information only in the performance of the receiving party's obligations under this Agreement or for internal purposes to improve the quality of service performed under this Agreement; and (iii) except as otherwise expressly provided herein, not disclose or grant access to the disclosing party's Confidential Information to any third party, without the prior written consent of the disclosing party. "Confidential Information" means non-public information that the disclosing party designates as being confidential to the receiving party or which, under the circumstances surrounding disclosure ought to be treated as confidential by the receiving party, including without limitation, information received from others that the disclosing party, is obligated to treat as confidential. Confidential Information does not include information that (i) is or subsequently becomes generally available to the public other than by a breach of a confidentiality obligation; (ii) is already in the possession of receiving party prior to disclosing party's disclosure to receiving party; (iii) is independently developed by receiving party without use or reference to the disclosing party's Confidential Information; (iv) becomes available to receiving party from a source other than the disclosing party other than by a breach of a confidentiality obligation, or (v) is required to be disclosed by law or regulation, including Tex. Gov't. Code Ann. Chapter 552 et seq., as amended (the "Texas Public Information Act"). B. Medical Records All parties to this Agreement shall comply with all applicable state and federal laws and regulations regarding confidentiality of patient records, including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and the Privacy Standards (45 C.F.R. Parts 160 and 164), the Standards for Electronic Transactions (45 C.F.R. Parts 160 and 162), and the Security Standards (45 C.F.R. Part 162) 2024-03-26 Psge 4 of 7 TTUHSC I IIIIII IIIIII II II IIIII) III �IIIII IIIIIII I) III�II IIII IIII I IIII'I IIIIII (I II IIIIII III IIIIII I'lllll II IIIIII IIII IIII ["'CON3808111'21'244241842304770598079278982387720895558782155025•4'7"'] newmeanynsc City of Lubbock CON3606111 (collectively, the "Standards") promulgated or to be promulgated by the Secretary of Health and Human Services on and after the applicable effective dates specified in the Standards. Notwithstanding the foregoing, the parties shall be permitted to enter into such Business Associate Agreements as are permitted or required by H[P�. VIII. Entire Aereement The Parties acknowledge that this MOU, including the incorporated attachments, is the entire agreement of the Parties and that there are no agreements or understandings, written or oral, between them with the respect to the subject matter of this MOU, other than as set forth in this MOU. By signing below, the Parties aclmowledge that they have read the MOU and agree to its terms and that the persons whose signatures appear below have the requisite authority to execute this MOU on behalf of the named party. Signature Page follows 2024-03-26 Page 5 of 7 ' I IIIIII (IIII� II II IIIIII III IIIII) IIIIIII �I IIIIII �III III) I I�IIII III�II (I II IIIIII III IIIIII IIIIIII II IIIIII III) (III ['••CON3606111•21•244241842304770599079278982387720895558782155025•5'7"'] �eynsC City of Lubbock CON3606111 CITY OF LUBBOCK: TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER: BY: T a ay , ayor �• .� • � . ATTEST: BY: Courtney Paz, City Secretary APPROVED AS TO CONTENT: Katherine Wells, City of Lubbock Health Director APPROVED AS TO FORM: achael Foster Assistant City Attorney P � BY; Penny Harkey (Mar , 202414:37 j NAME: Penny Harkey TITLE: �ecutive Vice President of Finance and Operations DATE: 03/26/2024 The following Attachments are attached and incorporated as part of the MOU: Attachment "A" SUBRECIPIENT's Participating Locations Attachments follow 2024-03-26 Page 6 of 7 TTUHSC I IIIIII IIIIII II II IIIIII III IIIIII IIIIII) II II�III IIII IIII I IIIII' IIIIII II II IIIIII III IIIIII I�IIIII II IIIIII IIII (I'I ("'CON3606111 •21 •244241842304770599079276992387720695556782155025'6'7"') aowe,udnynsC Ciry of Lubbock CON3606111 Attachment "A" SUBRECIPIENT's Participating Locations Site Name Address City ZIP Phone Number Allred 2101 FM 369 North lowa Park 76367 (940) 855-7477 Baten 1992 Helton Road Pampa 79065 (806) 665-7070 Clements 9601 Spur 591 Amarillo 79107 (806) 381-7080 Dalhart 11950 FM 998 Dalhart 79022 (806) 249-8655 Daniel 938 South FM 1673 Snyder 79549 (325) 573-1114 Formby 998 County Road AA Plainvlew 79072 (806) 296-2448 Fort Stockton 1536 IH-10 East Fort Stockton 79735 (432) 336-7676 Havins 500 FM 45 East Brownwood 76801 (325) 643-5575 Jordan 1992 Helton Road Pampa 79065 (806) 665-7070 L nau h 1098 South Highway Fort Stockton 79735 Y g 2037 (432)395-2938 Middleton 13055 FM 3522 Abilene 79601 (325) 548-9075 Montford 8602 Peach Street Lubbock 79404 (806) 745-1021 Neal*** 9055 S ur 591 Amarillo 79107 (806)383-1175 Roach 15845 FM 164 Childress 79201 (940) 937-6364 Robertson 12071 FM 3522 Abilene 79601 (325) 548-9035 Rudd**' 2004 Lamesa Highway Brownfield 79316 (806)637-6254 Sanchez 3901 State Jail Road EI Paso 79938 (915) 856-0046 Sayle 4176 FM 1800 Breckenridge 76424 (254) 559-1581 Smith 1313 CR 19 Lamesa 79331 (806) 872-6741 Mechler 4000 Highway 86 West Tulia 79088 (806) 995-4109 Wallace 1675 South FM 3525 Colorado Ciry 79512 (325) 728-2162 Wheeler 986 County Road AA Plainview 79072 (806) 296-2448 ***Neal and Rudd units are currently idle 2024-03-26 Page 7 of 7 I IIIIII IIIIII II II IIIIII III IIIIII IIIIIII II IIIIII illl IIII I IIIIiI IIIIII II II IIIIII III IIIIII IIIIIII II IIIIII IIII IIII ["•CON36Q8111•21•244241842304770589079278992387720695556782155025'7'7"'] Powa,ednynsc