Reverse Distribution Statement of Work 12-5-25-DRAFT.docx

Reverse Distribution Statement of Work Description of Services

1. General Information:

The purpose of this service would be to maintain compliance with VHA Directive

1108.01 and Title 21 Code of Federal Regulations and provide proper disposal of non-controlled and controlled substances that are deemed damaged, expired, returned, unusable, or otherwise unwanted that are lawfully possessed by registrant.

The reverse distribution process would provide VA Palo Alto Health Care System (VAPAHCS) pharmacy service a source of return via credits from controlled substances and non-controlled substances in the most optimal way. The reverse distributor contractor shall utilize a process to achieve maximum credit returns. A process to track the credits turned in and received back shall be in place. Any software containing such information shall be made available to the COR or designees with unlimited access. Disposal of controlled substance stock held for destruction are required to be completed at least quarterly. A DEA-licensed destruction company should be scheduled at least quarterly to meet this requirement but are not limited to the quarterly scheduled appointments. For purposes of this contract, the reverse distributor may be referred to as contractor or vendor.

2. Objectives/Requirements:

Any contractor that reverse distributes a controlled substance shall be registered as a reverse distributor and must be compliant with all applicable federal, state and local laws and regulations governing reverse distribution. Services required under this contract shall be performed in accordance with Federal Laws including but not limited to Title 21 Code of Federal Regulations. Contractor shall be compliant with any requirements of the VA as listed in this contract.

Contractor shall provide a representative to perform duties for each on-site pick up of expired or unusable controlled and non-controlled medications at VAPAHCS pharmacy service. Contractor shall be able to accommodate up to 22 pick-ups per period of performance based on VAPAHCS Pharmacy needs. VAPAHCS pharmacy service shall provide contractor a minimum of a two-week notice to schedule pickups.

Anticipated need for pick-up services would occur about once a month for the Palo Alto Division and once a quarter for Menlo Park and Livermore divisions.

3. On-Site Process:

Non-controlled substances held for reverse distribution shall be invoiced and acquired by reverse distributor on-site representative. Prior to boxing items, a pharmacy employee shall review with contractor during on-site service a list of items to ensure it matches that of what is actually acquired by reverse distributor and ensure there are no discrepancies between the pharmacy’s list of items and contractors list of items. Contractor shall be responsible for boxing up items acquired by the pharmacy and arranging for pick-up by carrier.

Controlled substance items held for destruction are placed in an evident tamper bag.

All bags shall be opened at the time of the transfer to a DEA-licensed destruction company and must be verified in the presence of the representative of the reverse distributor, pharmacy staff and an Accountable Officer (AO). The AO, pharmacist and representative from destruction company must sign the document listing of the controlled substances transferred from VA to the destruction company. The reverse distributor must provide a signed receipt for all CIII-V and DEA Form 222 for all CII products taken at the time of transfer. The CIII-V receipt and DEA Form 222 must include drug name, dosage form, strength, quantity and date of transfer. The pharmacy must maintain these records for three years in a readily retrievable manner. Once the on-site representative of the contractor verifies counts with the pharmacy staff and accountable officer and completes the paperwork of the transfer, and preparation for shipping the reverse distributor shall assume the title and responsibility to the products. Prior to boxing items, a pharmacy employee shall review with contractor during on-site service a list of items to ensure it matches that of what is actually acquired by reverse distributor and ensure there are no discrepancies between the pharmacy’s list of items and contractors list of items.

Contractor shall be responsible for boxing up items acquired by the pharmacy and arranging for pick-up by carrier. On-site representative shall arrange for immediate pick up by trusted carrier or shall have a DEA compliant transport process. The DEA registered reverse distributor who destroys the controlled substance must submit a DEA Form 41 to the DEA when the controlled substances have been destroyed.

The DEA Form 41 should not be used to document the transfer of controlled substances from the pharmacy to the reverse distributor. A copy of the DEA Form 41 should be sent to pharmacy point of contact if requested.

A reverse distributor shall acquire controlled substances from a registrant at the registrant’s registered location or receive controlled substances delivered by common or contract carrier. Controlled substances for destruction shall occur no later than 30 calendar days after receipt. A method of destruction shall render controlled substances for destruction non-retrievable in compliance with federal regulations.

4. Description of Items Eligible for Transfer:

Vendor shall accept any opened or unopened package of OTC, prescription in original containers and Scheduled CII-V medications being held for destruction obtained through return mail or otherwise deemed unusable or expired. All forms of medication shall be accepted such as tablets, capsules, suppositories, liquids, refrigerated items, patches, films, topicals, unused syringes containing medication but may not be limited to this list. Scheduled CII-V medications not contained in original manufacturer bottle packaging shall also be accepted for return. All controlled medications shall be counted and verified by vendor in presence of pharmacy staff member and VA accountable officer. Manufacturer and wholesaler recalled products not previously returned directly to manufacturer or wholesaler shall be returned to vendor for processing.

5. Supplies and Services:

The vendor shall be fully licensed to perform the work and shall take responsibility to complete details of the contract from start to finish. The responsibilities of the contractor shall include the ability to provide on-site and off-site services and provide all equipment, materials, and labor needed to process credit return and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances. The vendor shall bring all necessary supplies including equipment or software for their own use to perform their work as reverse distributor to each on-site pick-up. Vendor shall be responsible for their supplies and equipment including any loss or damage. Reverse distributor shall be responsible for packaging products transferred to them if shipping through carrier, including but not limited to generating shipping labels and providing compliant packaging.

6. Software or Web-based System:

Vendor shall provide the COR and designated pharmacy staff access to software programs to identify which products should be accepted by manufacturers for third party returns, which products are not eligible for return, products which have potential for return or potentially creditable products. This software can help separate waste to appropriate route prior to the scheduled reverse distribution pickups.

This software should be able to track progress on credit process such as pending manufacturer response, or credits already received. Web-based system shall provide status of credits, credit reconciliation and reporting capabilities for purpose of managing, tracking and comparing the processing of unused pharmaceutical returns across the government service or agency and arrange the facilitation of processing proceeds. Training shall be provided to COR and designated staff on utilization of this software. Representative or customer service should be available and able to provide efficient service support for staff for as needed assistance or questions at no additional charge for the entire duration of the resulting contract.

Web Based platforms must conform to VA rules, regulation and policy and must be reviewed by the ISSO before any agreement can be made. In addition to ISSO review, cloud based platforms must be Fed Ramp compliant or have solidified plans to be compliant within a time frame necessary to carry out the duties of the contract.

7. Credit and Funds Disbursement:

All reasonable efforts to comply with requirements and obtain credit for the VA shall be applied to achieve maximum credit return. Reverse distributor representatives shall provide education and guidance to designated staff if there are any applicable means to obtaining more credits for returned product.

A complete list of medications processed for reverse distribution shall be provided by on-site representative. Access to software shall be provided to designated individuals to track credit processing and credit reconciling. Vendor shall take all reasonable efforts to pursue and obtain credits through manufacturers and wholesalers, including but not limited to following up with manufacturers or wholesalers not responding or processing credits in a timely fashion (within 30 days of receipt). Vendor shall help facilitate the processing and crediting of returned product. Vendor shall work with manufacturers and customer’s wholesaler to facilitate the disbursement of checks or credits. Credits shall be deposited directly into wholesaler account or sent directly to the VA by check. VA shall have the rights to all credits as there should be no fluctuation in fee charges by the vendor or additional charges.

8. Performance Standards:

Vendors shall have recent proven past experience as a pharmaceutical reverse distributor to perform reverse distribution processing and waste disposal services in the volume required by VAPAHCS Pharmacy Service.

Vendor shall meet all requirements as listed in this contract as well as perform all processes compliantly with all federal laws and regulations.

Vendor shall be able to communicate efficiently for all VAPAHCS Pharmacy needs of this contract. Vendor shall be available for any inquiries by VAPAHCS Pharmacy staff. Invoicing shall be timely and provided within ninety days of each on-site service.

If services do not conform to contract requirements, the government may require the contractor to perform services again at no additional cost to the government. If defect in services may not be corrected by reperformance, the government shall have authority to reduce contract price to reflect the reduced value of the service performed.

9. Place of Service:

Representative shall provide on-site service to:

Department of Veterans Affairs VA Palo Alto Health Care System-Palo Alto Division Pharmacy Service 119 3801 Miranda Ave Palo Alto, CA 94304

DEA BO3745532

VA Palo Alto Health Care System-Menlo Park Division Pharmacy Service 119 795 Willow RD Menlo Park, CA 94025

DEA AV6806826

VA Palo Alto Health Care System-Livermore Division Pharmacy Service 119 4951 Arroyo RD Livermore, CA 94550

DEA BV5576674

Contractor shall provide education/training and guidance on software products used.

This may be done in person, virtually, or by telephone.

10. Invoice and Charges:

The Vendor shall not add or substitute service fees without prior approval from the contracting officer.

Contract fee is to include the service fee of the vendor which includes services of the representative on the days of on-site services, consultation/training on software use or inquiries regarding credits or processes, shipping costs, destruction fees, and manufacturer processing fees.

Invoices shall be issued within ninety days after each on-site service date. Each invoice fee shall not exceed previous quoted agreement as agreed to in this contract to be billed by flat service fee. Payment receipts shall be confirmed by contractor in writing via email or confirmation process.

Any inquiries that VAPAHCS Pharmacy may have through representative or customer service shall be provided at no additional charge at any time. Access to software should be available at any available time at no additional charge. Meetings in person, virtual or by phone including but not limited to discussion about process of returns or credit tracking shall be provided as necessary to VAPAHCS pharmacy at no additional charges.

11. Confidentiality:

Contractor shall be compliant with all security statutes including HIPAA (Health Insurance Portability and Accountability Act). Failure to comply with security statutes and confidentiality of patient information may result in financial sanctions and contractor shall be held liable if they are the cause of the breach of information.