Inactive

VISN 17 Pharmaceutical Reverse Distribution Statement of Work General The purpose of this solicitation is to establish one contract with a reverse distributor, hereafter referred to as the Contractor,... VISN 17 Pharmaceutical Reverse Distribution Statement of Work General The purpose of this solicitation is to establish one contract with a reverse distributor, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA) Veterans Integrated Service Network 17 (VISN 17), in processing returnable pharmaceuticals for manufacturer credit through the VA s Pharmaceutical Prime Vendor (PPV). The contract will include the VISN 17 pharmacy facilities within the following VA healthcare systems (HCS): El Paso VA HCS, North Texas VA HCS, and South Texas VA HCS with the ability to add or remove other VISN 17 pharmacies as needed. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize the violation of laws and regulations. The contractor shall be compliant with all applicable regulations related to reverse distribution of hazardous, non-hazardous, and controlled substance pharmaceuticals. Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 calendar days from authorized agencies approved to participate in the VA s Pharmaceutical Prime Vendor (PPV) program. The Contractor shall only accept over the counter (OTC) and pharmaceutical products including partial bottles in their original containers (that include a national drug code (NDC). Any other products are non-returnable and considered waste and must be destroyed by the VA facility in accordance with following applicable federal, state, and local laws and ordinance for waste disposal. Payments The exact payment amount of the Firm-Fixed fee to be made to the Contractor shall include only the awarded contracted fee for reverse distribution services as defined under Section 2, Awards, and shall be paid directly from the Government and not through credits. Invoices must be provided by the reverse distribution vendor to the returning facility within 30 calendar days of on-site service. Reverse Distribution Program Eligible Facilities The contractor shall provide pharmaceutical reverse distribution services for the fees awarded herein for the VISN 17 facilities below. Offerors are advised that a limited number of additional participants may be added or deleted by modification throughout the life of the contract. North Texas HealthCare System Dallas VA Medical Center 4500 South Lancaster Road, Dallas TX 75216 Sam Rayburn Memorial Veterans Center 1201 East 9th Street, Bonham, TX 75418 Fort Worth VA Clinic 2201 Southeast Loop 820, Fort Worth, TX 76119 Tyler VA Clinic 7916 S Broadway Ave, Tyler, TX 75703 South Texas HealthCare System Audie L. Murphy Memorial Veterans' Hospital 7400 Merton Minter Boulevard, San Antonio, TX 78229 Kerrville VA Medical Center 3600 Memorial Boulevard, Kerrville, TX 78028 Frank M. Tejeda Department of Veterans Affairs Outpatient Clinic 5788 Eckert Road, San Antonio, TX 78240 North Central Federal VA Clinic 17440 Henderson Pass, San Antonio, TX 78232 North West San Antonio HCC 9939 State Highway 151, San Antonio, TX 78251 El Paso HealthCare System El Paso VA Clinic 5001 North Piedras Street, El Paso, TX 79930 Valley Coastal Bend HealthCare System Harlingen VA Clinic 2601 Veterans Dr, Harlingen, Tx 78550 Harlingen Treasure Hills OPC 2106 Treasure Hills Blvd, Harlingen, TX 78550 Corpus Christi VA Clinic 205 S Enterprize Pkwy, Corpus Christi, Tx 78405 McAllen OPC 901 E Hackberry Ave, McAllen, TX 78503 Base +4OYs Base - 04/01/2023 to 03/31/2024 OY1 - 04/01/2024 to 03/31/2025 OY2 - 04/01/2025 to 03/31/2026 OY3 - 04/01/2026 to 03/31/2027 OY4 - 04/01/2027 to 03/31/2028 Regulatory Compliance The Contractor shall be required to provide all equipment, packaging materials, and labor needed to process and arrange for proper reverse distribution or disposal of designated pharmaceuticals, including Schedule II-V controlled substances, for contracted VISN 17 facilities. Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation; U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), 41 U.S.C. chapter 67, Service Contract Labor Standards and VA regulations. The Contractor shall also comply with applicable state/local regulations and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations. Accordingly, the Contractor shall arrange for, recommend, and/or advise the VISN 17 VA pharmacy of the proper means of transporting the products for manufacturer credit to the Contractor's central processing facility. Permits, Registration, Insurance All necessary permits and licenses required by Federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, etc. for individual contractor and subcontractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable and non-returnable items. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA and individual State regulations. The Contractor and any affiliated subcontractors shall be a licensed DEA registered reverse distributor able to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the contracting officer for retention in the contract file. The Contractor and any respective subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act, Clean Air Act, Clean Water Act, Occupational Safety and Health Administration, and all licenses and permits required by local agencies for reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses required for the transportation of hazardous wastes for each jurisdiction in which they will be operating under this contract. The Contractor and subcontractors shall have proper insurance coverage, including environmental remediation and be prepared to list the VISN 17 facilities as insured if awarded a contract. A copy of such insurance coverage shall be provided to the Contracting Officer, upon request. Shipping/Processing Arrangements The VISN 17 facility s contracting officer representative (COR) will contact the Contractor directly to arrange for a return credit service date. The Contractor shall provide on-site servicing within ten (10) business days from the date of the facility request and provide all instructions, forms, labels, and DEA required tamper-proof containers/pouches (as applicable) that are needed to transport the designated items to a Contractor's central processing facility. The Contractor shall comply with any participating facilities additional security requirements and procedures for access to facilities. Products qualifying for manufacturer s return are pharmaceuticals, including partial pharmaceuticals, that are in the original manufacturer containers. The contractor shall only accept medications that are expired or set to expire within 120 calendar days. While on-site, the Contractor shall prepare a complete inventory of the pharmaceuticals to be removed from the pharmacy, and the VA facility designee will validate the contents of the Contractor s inventory for accuracy by comparing it to the facility s own return for credit inventory. All discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. The Contractor shall not accept returns of medications that are not expired or within 120 calendar days of expiration. All services required as part of the pick-up must be included in the firm-fixed price. If the pick-up order requires more than one day to complete, the Contractor shall ensure that all controlled substance returns are reviewed and boxed for shipping from the facility by close of business on the same day of service. Chain of custody paperwork including a signed receipt for all Schedule III-V and DEA Form 222 for Schedule II shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for transport. During reverse distribution processing, if any controlled substances are destroyed, the DEA registered reverse distributor must submit a DEA Form 41 to the DEA when the controlled substances have been destroyed. The DEA Form 41 shall not be used to document the transfer of controlled substances from the pharmacy to the reverse distributor. If requested, a copy of the DEA Form 41 shall be made available to the pharmacy point of contact. Notification shall be provided to the facility COR within three (3) calendar days after initial processing is completed that the items have arrived at the Contractor s centralized facility. Within thirty (30) calendar days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through the return credit process in accordance with all applicable federal, state, and local regulations. Each site visit/pickup shall be assigned a single order/job processing number by the contractor. No batch processing of credits received by the vendor is permitted. Credits received and documented for each order/job number must be kept separate. This includes down to the NDC-level credits received. Credit Tracking and Reconciliation When actual credits are received, the Contractor shall update the database reflecting the actual credits received from the manufacturer and reconcile the difference between the estimated return value and the actual credits received based on the manufacturers debit memos. Debit memos must be requested by the Contractor from the manufacturers for all credits issued. The debit/credit memos shall be provided by the Contractor to each facility receiving credits and used for comparison of records/transactions of credits pending and credits received. On a quarterly basis, the Contractor and each facility will work together to reconcile any discrepancies between the facility records and the Contractor records. Discrepancies that cannot be resolved shall be brought to the attention of the VISN contracting officer representative (COR) who will further review and provide information to the contracting officer. Discrepancies resolution will be included on the quality assessment plan (QASP). To ensure adequate tracking of credits from inception to disposition, the Contractor shall make available the NDC-level itemized credit statements received from the manufacturers. The Contractor is responsible for communicating with the manufacturer to ensure that credits are received in a timely manner and to resolve issues of inadequate or non-payment of outstanding credits. All credits must be sent and processed through the PPV. The contractor shall instruct manufacturers to issue all credits directly to the PPV since the PPV has credit accounts established for each authorized user of the PPV Program for purposes including reverse distribution. Any credits received by the Contractor from the manufacturer shall be forwarded to the PPV within ten (10) business days from date of receipt. In addition, each facility that receives credits directly from the manufacturers as a result of reverse distribution processing will be instructed to notify the Contractor of receipt of such credits so that the Contractor can update their electronic reporting system. Credits will be deposited into the individual facility accounts by the PPV upon receipt of itemized credit statements for each individual facility provided by the Contractor. The credit statements provided by the Contractor to the PPV shall include the customer account number and appropriate invoice number to facilitate this process and for tracking purposes. Manifests, Memos, Reports The Contractor is responsible for providing detailed reports and data to the facility and VISN CORs within a reasonable time frame (examples and timeliness requirements below). The facility and VISN CORs shall be notified if the Contractor experiences any delays. The Contractor must also provide software that allows for cross referencing the site s electronic record of reverse distribution inventory and credits against the contractor electronic record to identify discrepancies. Facility designees are authorized to utilize Contractor software if no PHI/PII or other VA sensitive data is released/captured. On-site Return Inventory At the time of on-site processing, the Contractor shall list all items (including non-controlled and controlled substances) designated for reverse distribution on a return inventory. This list shall include, at a minimum: the Contractor s unique order/job number, date of service, product name, National Drug Code (NDC), DEA Schedule unit of measure, and quantity. The Contractor shall create separate inventories for the reverse distribution of Schedule II and Schedule III V controlled substances. During the on-site servicing, the pharmacy designee will utilize the locally created inventory to compare to the Contractor s inventory to ensure accuracy. The contractor s return inventory shall be available on the customer account portal within seven (7) calendar days of on-site visit. Destruction Manifest and Certificate of Destruction If a pharmaceutical product is removed from pharmacy by the Contractor and later found to be ineligible for credit, the contractor shall create a Destruction Manifest. This inventory list shall include, at a minimum: the Contractor-assigned original order/job number, customer account number, date of service, product name, strength, National Drug Code (NDC), DEA Schedule, quantity, unit of measure, disposal shipment number, manifest number, and the reason for non-eligibility for credit. The contractor shall create separate manifests when disposing of Schedule II and Schedule III V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. The Contractor shall provide Destruction Manifests to the returning facility within thirty (30) calendar days of Contractor's shipment processing. A Certificate of Destruction that includes, at minimum, the original order/job number, customer account number, disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be provided by the Contractor to the returning facility and maintained on the reporting website upon completion of destruction. The Certificate of Destruction/Affidavit must be provided by the Contractor within thirty (30) calendar days of the completion of destruction. Return Detail Report The Contractor shall create a post-processing return detail report for each order/job number and provide it to the returning facility within forty (40) calendar days of the on-site servicing. This report shall show the processed status of each returned item within the order/job and include at a minimum, the customer account number, unique order/job number, date of service, product name, NDC, strength, quantity returned, unit of measure, full/partial container status, estimated return value, reason for non-eligibility for credit (if applicable). Credit Report A credit report shall be provided by the Contractor which shows the estimated credits and actual credits received for each NDC item including total actual credit received and credit received by unit of measure, as well as the date that the credit was issued. This report shall also include at a minimum, the customer account number, order/job number, invoice numbers, product name, DEA Schedule, NDC, dosage form, quantity returned, date returned, unit of measure, full/partial container status, and any associated manufacturer or PPV debit/credit memo IDs. Credit information shall be direct from the manufacturers credit memo to the itemized NDC-level item, not from batch processing. Debit Memo and Credit Memo Report The Contractor shall have a report that connects the reverse distribution debit memo, the manufacturer credit memo (itemized product and credit), and the PPV credit memo to ensure adequate tracking of credits from inception to disposition. Memos must be requested by the Contractor from the manufacturers and the PPV for all credits issued. Credit and Debit memos will be provided by the Contractor to each facility receiving credits and used by each facility for comparison of records/transactions of credits pending and credits received. Service Invoices The Contractor shall make all service invoices available online. These invoices shall include, at minimum, the specific invoice ID, invoice date, order/job number, service date, and payment received date. Item-Level Detail Report The Contractor shall provide a report which would allow for the ability to search for a particular NDC and find all previous reverse distribution data for that product regardless of job/order number and service date. This will be utilized by facilities for inventory management purposes. Web Portal/Dashboard Reports The Contractor shall provide a web-based customer portal that allows for both individual facility and VISN aggregate and item-level detail reports. VISN and local facility designees at each facility must be allowed access to track, monitor, and reconcile reverse distribution services and activities. The Contractor shall provide web portal and report access training to end users within 60 calendar days of contract start date and then as required thereafter (see Section 12: Training Requirements). The online reporting system shall be configured in such a way to track the reverse distribution process at the itemized-level from start (return) to finish (credit or destruction). An electronic inventory-submission portal for notification of credit eligibility shall be available to ensure accurate assessment of pharmacy returnable items prior to on-site servicing. The reports on the portal shall be exportable to Microsoft Excel for reconciliation and analysis purposes and at a minimum include what is described in Section 10 (Manifests, Memos, Reports). The web portal shall include reporting to identify open orders/jobs and order/job summaries. NOTE: VISN 17 Pharmacy Benefits Management (PBM) shall have access to all VISN 17 facilities accounts and web-based reporting tools. The reports shall be constructed to allow the customers maximum flexibility to sort the data and aggregate or drill down as needed. Training Requirements The Contractor shall provide, at no cost to the Government, training down to the facility level on the various reports and functionality of reports to assist the facilities in monitoring and tracking the reverse distribution program at the start of the contract. Training shall include actual demonstration and operation of the web-based online reporting system. In addition, the Contractor shall provide any updates and system changes as needed by the Contractor, along with the required training prior to the adoption of changes as they occur throughout the term of the contract at no additional cost. The contractor shall notify all sites 14 calendar days before the date of their scheduled training. Initial Start of Contract Training shall cover at a minimum the following: Full web access and reports training, including targeted data extrapolation. Reviewing and exporting reports, memos, manifests, and invoices. How to report discrepancies That credits shall not be used by VA facilities to pay for fees, services, or additional value-added services from the Contractor, such as report customization or additional site visits. That non-returnable products are considered waste and the Contractor and VA facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. A contact person and telephone number shall be provided to each facility in the event of the need for customer service or if additional questions arise as necessary at no additional charge. Implementation Plan Offerors shall submit a written proposed plan detailing implementation of the Pharmaceutical Reverse Distribution Program including details on how billing will be completed (credit card, PO, etc.). Recognizing that some facilities may prepare their pharmaceutical returns monthly, the Government anticipates no more than sixty (60) calendar days from the date of award to transition facilities over to the new contract. Additional information regarding invoicing procedures is included in the clauses. Contingency Plan The contractor shall submit and maintain a plan for contingency operations, which identifies the ability to provide uninterrupted support of the requirements outlined in this solicitation under emergency and/or contingency conditions. Contract Administration Authority The VISN 17 Contracting Officer (CO) is the only person authorized to approve changes or modifications to the requirements under this contract on behalf of the Government. In the event the Contractor makes any changes at the direction of any person other than the VISN 17 Contracting Officer, such changes shall be considered to have been made without authority and any adjustments in price involved as a result of unauthorized changes to the contract will not be ratified. VISN 17 will have a designated Contracting Officer s Representative (COR) who will serve as a point of contact for all matters pertaining to the technical aspects of the contract. At time of contract award, or upon appointment the Contractor will be furnished with a copy of the COR s appointment letter. CORs have limited authority as delineated by the cognizant Contracting Officer in their appointment letter and cannot make any commitment obligating the Government. Each facility will have a designated COR/Ordering Officer. Only VA personnel officially designated as the contract COR/Ordering Officer may place orders under this contract. The COR/Ordering Officer does not have the authority to negotiate, to make commitments, or to make changes that will affect the terms or conditions of this contract. The VISN 17 COR will be responsible for tracking and assessing the performance of the Contractor during the contract term in conjunction with any reports or analyses provided by the facilities COR/ordering officer. Federal Government Holidays The following information is provided to assist the Contractor in scheduling returns when on-site service is required: New Year's Day January 1st Martin Luther King's Birthday Third Monday in January Washington s Birthday Third Monday in February Memorial Day Last Monday in May Juneteenth National Independence Day June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th Note: If a holiday falls on a Saturday or Sunday, the contractor shall contact the returning facility to determine on which day (Friday or Monday) the holiday will be observed.