THIS IS A REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT (SS) *PLEASE NOTE*: THIS IS A FOLLOW-ON RFI/SS TO THE REQUEST ISSUED ON JUNE 23RD, 2024 (36C77024Q0325) AS REVISIONS HAVE BEEN MADE TO THE STATEMENT OF WORK. PLEASE REVIEW ATTACHED UPDATED VERSION. IF YOU RESPONDED TO THE PREVIOUS RFI, YOU ARE REQUIRED TO RESPOND TO THIS REQUEST AS WELL INCLUDING ANSWERING ALL QUESTIONS BELOW. THANK YOU. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION: This is NOT a solicitation announcement. This is an RFI only. The purpose of this RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 561499 All Other Business Support Services. Responses to this RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this RFI, a solicitation announcement may be published. Responses to this RFI are not considered adequate responses for a solicitation announcement. The following VAAR policies and clauses will be applicable to this requirement if an SDVOSB/VOSB entity is interested and qualified in this requirement: Limitations on Subcontracting requirements set forth in 15 U.S.C. § 657s and in VAAR 852.219-10 and 852.219-11; 852.219-77, VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following: Pharmaceutical Reverse Distribution Services for All CMOP Facilities It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the services above. Please see attached Statement of Work for more details regarding the services requested. If you are interested and capable of providing the sought-out services, please provide the requested information below. Please provide the following: Company Name Address Point of Contact Name, Phone Number, and Email Address SAM UEI No. Please indicate the size status and representations of your business, such as, but not limited to: Service-Disabled, Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman-Owned Small Business (WOSB), Large Business, etc.). Is your company considered small under the NAICS code identified under this RFI? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other Federal contract that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling and convincing evidence that you can meet the requirement described in the attached Statement of Work. Responses to this notice shall be submitted via email to Renee Kreutzer at renee.kreutzer@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Tuesday, December 10th, 2024, at 5:00PM CDT. If a solicitation is issued, it shall be announced later and all interested parties must respond to that solicitation announcement separately from their response to this RFI. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. PERFORMANCE WORK STATEMENT REVERSE DISTRIBUTION SERVICES DEPARTMENT OF VETERANS AFFAIRS NATIONAL CONSOLIDATD MAIL OUTPATIENT PHARMACY (CMOP) GENERAL The purpose of this solicitation is to establish one contract with a reverse distributor with destruction capability, hereafter referred to as the Contractor, capable of assisting the Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP), in achieving maximum credit return and in destruction related pharmaceutical waste that may arise out of non-returnable pharmaceuticals. The Government's need for on-site and off-site processing function is imperative to assure optimum inventory control and to minimize any violation of laws and regulations, especially in pharmaceutical waste disposal. The contractor shall be compliant with all applicable regulations related to hazardous waste handling. It is the intent that an efficient returns processing method where expired pharmaceuticals shipped to a centralized reverse distributor will reduce total costs in the health care system Returns to be processed will cover expired pharmaceuticals and pharmaceuticals due to be expire within 120 days from authorized agencies approved to participate in the VA s Pharmaceutical Prime Vendor (PPV) program. Contractor shall only accept OTCs and pharmaceutical products including unit dose and partial bottles any other products will be returned to the facility by the Contractor at the expense of the facility. AWARD The Government intends to award one (1) Indefinite Delivery, Indefinite Quantity, Firm-Fixed Price contract, resulting from this solicitation for a potential five-year period of performance. The Government will make this award based on Technical Capability, Past Performance and Price. Service fees shall be firm fixed price and represent all the company s costs for estimating the return value for expired or near expired pharmaceuticals, the shipping of the pharmaceuticals between the CMOP and the manufacturer, and the costs associated with the destruction of the non-returnable pharmaceuticals. Estimated return value is the amount that is expected to be credited based on the pricing file on the date the material arrives at the Contractor s processing facility. ESTIMATED ANNUAL REQUIREMENTS The estimated volume for each facility listed in Attachment A represents the Government s best estimate of annual returns in dollars and pounds of disposal that will be made through resultant contracts. The performance period, inclusive of the base year all four option years and the 6-month option to extend. SHIPPING/PROCESSING ARRANGEMENTS The CMOP will contact the Contractor directly to arrange for a return shipping date. The Contractor shall provide all instructions, forms, labels, and DEA approved tamper-proof pouches needed to ship the designated items to a Contractor's central processing facility. Facilities will make the determination whether to have a contractor work on-site to list all pharmaceuticals and prepare their outdated products for shipment to the reverse distribution facility for processing or have the Contractor provide off-site service. Whether the returns are processed using the Contractor s on-site representative or via off-site processing, the Contractor is responsible for the shipment and associated costs from the facility to the Contractor s reverse distribution facility. If on-site service is desired, the Contractor shall provide on-site servicing within ten (10) business days from the date of the facility request. When proposing fees in response to this solicitation, the Contractor shall anticipate, per the attached site visit calendar year per facility. The Contractor responsible package and ship returns from the CMOP facility, and the determination will be made initially defined product that is returnable as credit worthy and secondly product that is non-returnable for credit they are leaving at the site. The facility shall prepare a list of pharmaceuticals removed from the pharmacy and the vendor must validate the contents of the list for accuracy before leaving site. Any discrepancies shall be resolved prior to the removal of the pharmaceuticals from the facility by the Contractor. Large or special pickups requiring separate removal shall be scheduled within 48 hours of service, and daily updates will be provided to the facility until pickup is complete. Chain of custody paperwork shall be prepared for controlled substances and given to the returning facility by the Contractor at the time the package(s) are prepared for shipment. Within thirty (30) days of receiving the returned goods, the Contractor shall process all designated items by sorting, listing, and processing items through either a manufacturer's credit program or through the disposal process in accordance with all applicable federal, state, and local regulations. The Contractor shall comply with any participating customers additional security requirements and procedures for access to facilities. All costs associated with gaining access to any customer facility shall be the responsibility of the Contractor. PHARMACEUTICALS QUALIFYING FOR MANUFACTURER'S RETURN Products qualifying for manufacturer s return are pharmaceuticals, including partials pharmaceuticals, in the original manufacturer containers. Everything else is considered waste and facilities must follow applicable federal, state, and local laws and ordinance for waste disposal. For pharmaceuticals that qualify for manufacturer s return, the Contractor shall provide the returning facility a report stating the Estimated Return Value (ERV) of those items. The ERV will be used by the customer and the Contractor as an estimate for the amount that is expected to be credited. To obtain the manufacturer's ERV the Contractor shall contact the drug manufacturer for ERV estimate. PHARMACEUTICALS INELIGIBLE FOR CREDIT FROM MANUFACTURER The Contractor shall list all items (including non-controlled and controlled substances and non-hazardous and hazardous substances) designated for disposal on a disposal manifest. This list will include at a minimum product name, National Drug Code (NDC) or catalog number, quantity, total estimated return value, and reason for non-eligibility for credit. Separate manifests shall be provided for the disposal of Schedule III V controlled substances and when disposing of hazardous waste products as defined by the EPA Resource Conservation and Recovery Act (RCRA) regulations. A Certificate of Destruction including the disposal date, destruction method, destruction location, weight, disposal company name and proof of destruction affidavit shall be provided to the returning facility and maintained on the reporting website upon completion of destruction. All Manifests shall be provided to the returning facility within 30 calendar days of Contractor's item receipt, with the exception of the Certificate of destruction/Affidavit which shall be provided within 30 days of the completion of destruction. Shipments to the Contractor that require transport to the disposal location shall be done via approved and licensed vehicles in accordance with federal, state, and local laws and regulations where the processing will be completed. Contractor spills or releases of toxic/hazardous substances into the environment shall be reported to the returning facility immediately. PAYMENTS When actual credits are applied by the PPV through the Fast pay account, the Contractor shall update its 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 credit memos. Credit memos must be requested by the Contractor from the manufacturers for all credits issued. Credit 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, credits received. On a quarterly basis, the Contractor and each agency/facility will work together to reconcile any discrepancies between the facility records and the Contractor records. The exact payment amount to be made to the Contractor shall include only the awarded contracted flat fee for credit worthy returns and returns taken from the facility and later deemed non-credit worthy shall be disposed of at the fixed flat fee, To ensure adequate tracking of credits from inception to disposition, the Contractor shall provide the PPV confirmation of itemized credit statements received from the manufacturers at least on a monthly basis. The contractor shall direct and coordinate manufacturers credits directly to the PPV. The PPV has credit accounts/GLN List 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 agency/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. Based on the above, any arrangements to facilitate the processing of credits through the PPV must be made solely between the Reverse Distributor and the PPV. Any fees associated with this arrangement shall not be removed from the facility credits due. Within 15 days from receipt of award, the CMOP Contracting Officer shall be notified by the contractor awarded a contract under this solicitation if any business-to-business agreements cannot be reached with the VA PPV. WEB-BASED SERVICE REQUEST ORDERING SYSTEM The contractor shall provide an 800 number and a web-based service request ordering system for work order placement by customers. At a minimum, the system shall include entry fields for Facility Name, Address, City, State, Zip Code, Contact Name, Phone Number, E-mail, DEA Number, Desired Pickup Date, Description of Returns and Estimated Quantity. In addition, the web-based service request ordering system shall allow for electronic order confirmation, inventory status of credits, credit reconciliation, and reporting capabilities to allow facilities to track from inception of product to credit disbursement and/or disposal. REVERSE DISTRIBUTION PROGRAM ELIGIBLE FACILITIES Government Participants. The contractor shall provide reverse distribution services at the fees awarded herein for the facilities below as well as other government agencies approved to participate in the VA s Pharmaceutical Prime Vendor (PPV) program. Consolidated Mail Outpatient Pharmacies (CMOPs) VA CMOP Leavenworth 760 5000 South 13th St Leavenworth KS 66048 **VA CMOP Leavenworth/Shawnee 760 23501 West 84th Shawnee KS 66048 **Future Location VA CMOP Chelmsford 761 10 Industrial Ave. Chelmsford, MA 01824-3610 VA CMOP Tucson 762 3675 Britannia Dr Tucson, AZ 85706 VA CMOP Lancaster 763 2962 S. Longhorn Dr Lancaster, TX 75134 VA CMOP Murfreesboro 764 5171 Sam Jared Drive Murfreesboro, TN. 37130 VA CMOP Murfreesboro II 764 3209 Elam Farms Pkwy Murfreesboro, TN 37127 VA CMOP Hines 765 5th and Roosevelt Bldg. 37 NW Dock 18 Hines, IL 60141 VA CMOP Charleston 766 4136 Carolina Commerce Parkway Ladson SC 29456 Offerors are advised that a limited number of additional participants may be added or deleted by modification throughout the life of the contract. IMPLEMENTATION PLAN Offerors shall submit a written proposed plan detailing implementation of the Reverse Distribution Program including details on how billing will be completed (credit card, PO, etc.). Recognizing that some facilities may prepare their returns on a monthly basis, the Government anticipates no more than sixty (60) days from the date of award to transition facilities over to the new prospective contracts. Billing requires the ability to accept both credit card (Visa and MasterCard) and invoice options depending on the value of the transaction. Individual orders will specify the local options. 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. REPORTS The Contractor shall provide a return detail report by manufacturer to each returning facility within (30) calendar days after processing for all credit returns. This report should include at a minimum, the customer account number, applicable order or invoice number, product name, NDC or catalog number, lot or batch number, quantity returned, date returned, unit of measure, estimated return value, and a list of non-returnable pharmaceuticals with the weight and cost for disposal. An additional credit report shall be provided showing both the estimated credits and actual credits received, including total actual credit received and credit received by unit of measure for each NDC, as well as the date that the credit was issued, and identify contractor fees taken for each pharmaceutical return. The contractor shall provide copies of the manufacturer credit memos with this report to ensure adequate tracking of credits from inception to disposition. Separate reports shall be provided for Schedule III V controlled substances and for hazardous waste to include weight of disposal. The Contractor shall provide a web-based reporting tool that will generate the following reports: Monthly status reports of credit receipts listing the contract/order or invoice number, manufacturer, estimated return value, actual return value, and pending credits from the contractor to the facility. Monthly reconciliation reports for each individual account. Reconciliation data shall include but not be limited to NDCs, quantities, partial/full data, product names, vendors, strengths, sizes, and forms. Quarterly roll-up reports shall be provided to the Program Offices identified below which include, as a minimum the ERV for non-credits (destruction), charges for services, credits received, and credits pending. All three above referenced reports shall be made available on the reporting website and sent to the following personnel: VA Reporting requirement shall be emailed to the designated CMOP National Office Personnel which will be designated on the award document and the Option year renewals. VA Reporting Requirements: format: ^ delimited text file AND Excel Spreadsheet, VA example report headers shown below. (Report only completed transactions within the applicable reporting period) VA Station Number Contractor Name (reverse distributor) Customer Name (facility name) Customer Number (internal contractor customer number) DEA Number (IF APPLICABLE; 9 alpha numeric designator) Job Number (internal job number assigned) Wholesaler Account Number (account number credit routed to) Service Date NDC Number (National Drug Code; 11 digits; no dashes) NDC Package Size UPC (if no NDC exists) Product Name Manufacturer DEA Class (3, 4, or 5; leave field blank if non-controlled) LOT Number (IF APPLICABLE) QTY Returned (As decimal of total number of NDC units) Unit of measure (bottles, tablets, cases, etc.) Form (SOL solution; CAP capsule; TAB tablet; SYR syrup; KIT kit; SGL soft gels; PDR powder; PKT packet; CRM cream; OIN ointment; INJ - injection) Expiration Date Processing Fee (on-site / off-site fee assessed) HAZ Disposal Cost NON HAZ Disposal Cost ERV (estimated return value) ARV (actual return value) Credit Date (date credit awarded to customer) Credits (total credit received and credit received by unit of measure) Pending Credits (future credits due) Non-Return Value Returnable (Y/N) (indicate if returnable) NOTE: VA will have access to all customers web-based reporting tools. The reports should be constructed to allow the customers maximum flexibility to sort the data as needed. A typical report should provide the customer s name, address, and phone number, NDC of drug, generic or brand name (when appropriate), manufacturer, quantity returned and unit of issue (e.g., tablets, milliliters, and grams), ERV or non-returnable with a reason code. DASHBOARD REPORTING REQUIREMENT The reverse distribution vendor shall provide a web-based corporate level dashboard and reverse distribution information system available to the user at each facility or each agency for the purpose of managing, tracking and comparing the processing of unused pharmaceutical returns across the government service or agency. The web-browser based application is the preferred and required type of digital dashboard specified by this contract. The reverse distribution information system shall provide for multiple levels of access based upon the users level within the government service or agency (e.g., office of the surgeons general, regional or local facility) and shall provide data elements based upon standard variables (see paragraph 17, reporting requirements for metric and key performance indicators). The digital dashboard and reverse distribution information system shall be configured to track the flow of business processes associated with the return, destruction, disposal, waste, credit or other disposition of unused pharmaceuticals processed from the agency through the reverse distributor. The system shall provide graphic representation (i.e., dials, graphs, charts, etc.) of high-level processes and allow for drill down into low level data, with the purpose of allowing agency executive level leaders the ability to view and make comparisons of return processes and data across the agency. The dashboard shall use standardized metrics and key performance indicators and display these data points to allow comparison between different levels of the agency (i.e., agency or service level, and regional level). The digital dashboard shall display data elements in both a control panel format and database table format. Users will be able to generate and export data from the control panel into a downloadable spreadsheet (e.g., Excel spreadsheet). The digital dashboard and reverse distribution information system will allow users to monitor the return of unused pharmaceuticals through the vendor and compare the activities of the various levels (i.e., agency or service level, and regional level). Features and benefits of the dashboard and reverse distribution information system shall include visual presentation of performance measures. ability to identify and correct negative trends; measure of efficiencies/inefficiencies; ability to generate detailed reports showing new trends; overall visibility of the activities across an agency or service. efficient identification of data outliers and correlations. The dashboard software/application will provide decision makers with the input necessary to manage the reverse distribution business process by providing a web-based graphical user interface designed to display summaries, graphics (e.g., charts, graphs, gauges) in a portal-like framework to highlight important information and benchmark across a corporate, regional and treatment facility level so that the number of pharmaceutical credits across the systems can be maximized. TRAINING REQUIREMENTS The Contractor shall provide, at no cost to the Government, orientation and training down to the facility level on the various reports and functionality of reports to assist the facilities in monitoring and tracking potential credits. Training shall include actual demonstration and operation of the web-based electronic service request ordering system. In addition, the Reverse Distributor shall provide updates and system changes, and training prior to the adoption of changes as they occur throughout the term of the contract. Training should be provided on-site at each participating customer s facility. The contractor shall notify all sites 14 calendar days before the date of their scheduled training. Training shall cover at a minimum the following: Full web access and reports training, including targeted data extrapolation. Reconciliation reports between estimated and actual credits. Potential inventory management strategies. An instructional user guide with step-by-step instructions on the above topics shall also be provided via a link on the reporting website. A contact person and telephone number shall be provided to each facility in the event additional instruction is necessary or if there is a change in personnel. CONTRACT ADMINISTRATION AUTHORITY Only VA personnel officially designated as Ordering Officers under the Reverse Distribution contract or warranted contracting officers may place orders under this contract. Ordering Officers do not have the authority to negotiate, make any commitments or changes that will affect the terms and conditions of this contract. Ordering Officer Designations pertain only to the CMOP s. 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 2nd Martin Luther King's Birthday, Third Monday in January President's Day, Third Monday in February Memorial Day, Last Monday in May Juneteenth, June 19 Independence Day, July 4th Labor Day, First Monday in September Columbus Day, Second Monday in October Veterans Day, November 10th Thanksgiving Day, Fourth Thursday in November Christmas Day, December 25th *If these holidays fall on a Saturday or Sunday, the contractor should contact the returning facility to determine on which day (Friday or Monday) they will be observed. Annual Federal Holiday schedule may be attained at https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ The following represents the current VA Pharmaceutical Prime Vendor as of the date of this solicitation. The Contractor will be given notice via e-mail within 90 days when a change occurs. McKesson Corp. Pharm. Group 1220 Senlac Drive Carrollton, TX 75006 Point of Contact: Ms. Lori White, V.P. National Accounts Phone: 972-446-5758 Fax: 972-446-5337 Line Item 0001: On-Site Processing at a Government Facility of Returnable Pharmaceuticals (Controlled and Non-Controlled Substances). Propose prices as a percentage of the actual credits to be received from pharmaceutical suppliers. Invoices must be submitted; payments will not be made through credits . CONTRACT YEAR ESTIMATED ANNUAL RETURNS PROCESSED UNIT PRICE TOTAL AMOUNT Base Year % of Actual Credits Received Option Year 1 % of Actual Credits Received Option Year 2 % of Actual Credits Received Option Year 3 % of Actual Credits Received Option Year 4 % of Actual Credits Received 6 Month Option to Extend % of Actual Credits Received Subtotal Line Item 0002: Off-Site Processing at the Contractor s Facility of Returnable Pharmaceuticals (Controlled and Non-Controlled Substances). Propose prices as a percentage of the actual credits to be received from pharmaceutical suppliers. CONTRACT YEAR ESTIMATED ANNUAL RETURNS PROCESSED UNIT PRICE TOTAL AMOUNT Base Year % of Actual Credits Received Option Year 1 % of Actual Credits Received Option Year 2 % of Actual Credits Received Option Year 3 % of Actual Credits Received Option Year 4 % of Actual Credits Received 6 Month Option to Extend % of Actual Credits Received Subtotal Line Item 0003: Disposable of Non-returnable Non-Hazardous Pharmaceuticals. Propose as a firm fixed price per pound. CONTRACT YEAR ESTIMATED ANNUAL RETURNS PROCESSED UNIT PRICE TOTAL AMOUNT Base Year % Of Actual Credits Received Option Year 1 % Of Actual Credits Received Option Year 2 % Of Actual Credits Received Option Year 3 % Of Actual Credits Received Option Year 4 % Of Actual Credits Received 6 Month Option to Extend % Of Actual Credits Received Subtotal Line Item 0004: Disposal of Non-Returnable Hazardous Pharmaceuticals. Propose prices as a firm fixed price per pound. CONTRACT YEAR ESTIMATED ANNUAL RETURNS PROCESSED UNIT PRICE TOTAL AMOUNT Base Year % of Actual Credits Received Option Year 1 % of Actual Credits Received Option Year 2 % of Actual Credits Received Option Year 3 % of Actual Credits Received Option Year 4 % of Actual Credits Received 6 Month Option to Extend % of Actual Credits Received Subtotal
