JA - Prescription Drug Monitoring Program PDMP - REDACTED.docx

Control Number VA-24-00010649 State Prescription Drug Monitoring Program (PDMP) Sustainment Support Services Control Number VA-24-00010649

JUSTIFICATION

FOR AN EXCEPTION TO FAIR OPPORTUNITY

2. Description of Action:

The proposed action is for a firm-fixed price (FFP) task order placed under the Transformation Twenty-One Total Technolgy Next Generation (T4NG) contract for Prescription Drug Monitoring Program (PDMP) brand name Bamboo Health Prescription Monitoring Program (PMP) Gateway SaaS licenses and sustainment support services for VA, Office of Information & Technology (OIT) Enterprise Portfolio Management Division, Health Portfolio, Clinical Services.

3. Description of the Supplies or Services:

The proposed action seeks to provide sustainment and SaaS licenses for VHA critical PDMP solution. The Integrated PDMP solution enables authorized controlled substance prescribers, pharmacists, and their delegates to access crucial Veteran medication information from multiple participating PDMP databases with the click of a button in the Veteran’s electronic health record.

The PDMP solution depends on a backend SaaS provider with brand name PMP Gateway. The original equipment manufacturer is Bamboo Health (formerly Appriss). Brand name Bamboo Health PMP Gateway connects the VA's Veterans Data Integration and Federation (VDIF) middleware, Veterans Health information System and Technology Architecture (VistA) electronic health record, and Computerized Patient Record System (CPRS) Graphical User Interface (GUI) to the existing National Association of Boards of Pharmacy (NABP) PMP InterConnect (PMPi), a data sharing platform utilized by a network of participating state PDMPs.

In addition to the SaaS licenses, the required sustainment support services include maintenance, technical support, and enhancement releases. Security activities, such as system monitoring, investigation of security scan findings, and maintaining security documentation necessary to preserve the Authority to Operate (ATO), are also part of the sustainment support services.

The period of performance shall consist of one 12 month base period with one (1) additional 12-month option period, and two Optional Tasks. The total estimated value of the proposed action is REDACTED

4. Statutory Authority:

Pursuant to Federal Acquisition Regulation (FAR) 16.505(a)(4), the following brand name requirement is being justified and approved as an exception to fair opportunity under the statutory authority of Section 41 U.S.C. 4106(c)(2) as implemented by FAR 16.505(b)(2)(i)(B), entitled “Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.”

5. Rationale Supporting Use of Authority Cited Above:

Based on Market Research, it is anticipated that competition will be limited among resellers. No other SaaS solution can meet VA interopability or compatibility requirements associated with VA’s Integrated PDMP Solution other than brand name Bamboo Health PMP Gateway. Specifically, the VDIF middlware, VistA EHR, and CPRS GUI have each undergone significant development and configuration to only work with the brand name Bamboo Health PMP Gateway product. If any other SaaS product was to be utilized, it will not be able to exchange data between the three different VA systems and the participating PDMPs, because those systems are only configured to work with brand name Bamboo Health PMP Gateway for data sharing across PMP Interconnect. Additionally, dashboards have been developed to support monitoring and tracking of critical data and analytics associated with the Integrated PDMP Solution. These would not work with another brand name product and would need to be rebuilt. The VA Integrated PDMP Solution, including the dashboards, are built soley around brand name Bamboo Health PMP Gateway and NABP PMP Interconnect products, processes, and ecosystems. If a different SaaS product was utilized, this would require significant reconfiguration changes, code redevelopment, and testing for each of the aforementioned products: VDIF, VistA, CPRS, and associated dashboards. VA estimates that this extensive redevelopment and reconfiguration effort would result in 1 year and REDACTED in duplicated costs that would not be recovered through competition. These estimates are based on similar redevelopment and reconfiguration efforts. In addition to development duplicated costs and time, prior/current data would require remapping to new product data definitions to support functionality and continuous reporting/analytics capabilities from system launch through future state. In addition to vendor costs, a new solution would require VA staff to recreate process, education materials for the field, resource training, and so forth. Furthermore, selection of a new product would delay VA’s ability to immediately address necessary enhancements contained in the backlog.

Brand name Bamboo Health PMP Gateway is fundamental to integrating PDMP query functionality into both legacy and Oracle Health EHR settings. The underlying databases in both current and future state EHRs communicate through their respective middleware software to VA PMP Gateway which then sends the request through PMP InterConnect to participating state, regional, and territory PDMPs. The query response passes any results back through the VA PMP Gateway to the appropriate EHR, displaying them in a standardized PDMP Report which is intended to support real-time clinical care decisions. Additionally, the use of brand name Bamboo Health PMP Gateway in both systems is critical as we continue to address our ongoing efforts to integrate the remaining individual state and municipal PDMPs. Therefore, maintaining the connection to VA PMP Gateway will continue to ensure seamless interoperability regarding PDMP's form, function, and overall user experience across the current (VistA/CPRS) and future state (Millennium) EHRs.

Based on previous actions, this redevelopment would take at a minimum 12 months, and cost the government in duplicated costs of at least an estimated REDACTED. This estimate is based on previous development costs associated with the integrated functionality in the electronic health record in addition to the reporting tools and dashboards.

In addition, brand name Bamboo Health PMP Gateway was issued an Authority to Operate (ATO) by the VA and is currently under PMO Review for FedRAMP Authorization. Integrating a new solution with VistA would result in duplicated costs and implementation time, along with a heightened risk of negatively impacting patient care. Obtaining a security ATO for a replacement software package could take an additional 12-18 months or longer for FedRAMP review. The ATO security process is in place for the federal government agency to determine whether to grant a particular information system authorization to operate for a certain period of time by evaluating if the risk of security controls can be accepted.

This service is critical to the extensive coordinated effort between the VA and the vendor to broker sharing agreements with states, territories, and municipalities. The VA PDMP Integrated Solution operates on a sharing structure with additional states that a competitor would need to re-build from the ground up. Thus, introducing the risk of a significant and lengthy interruption of service to VA staff.

Also, PMP Gateway is the sole product capable of connecting the VA to the National Association of Boards of Pharmacy’s (NABP) PMP InterConnect, enabling access to 52 out of 54 PDMP databases. This solution plays a pivotal role in the VA's commitment to becoming a High Reliability Organization, addressing the ongoing US opioid epidemic, and equipping care providers with comprehensive patient information to enhance patient safety.

Additionally, only a Bamboo Health reseller can provide the sustainment services since any soure needs access to Bamboo Health proprietary code to ensure the services are properly configured.

Failure to utilize brand name Bamboo Health PMP Gateway product would significantly and adversely affect the quality of care that the VA can provide to veterans. PDMPs serve as a vital risk mitigation tool for prescribing controlled substances, such as opioids, stimulants, benzodiazepines, and more. Based on FY23 data, approximately 451,000 veteran patients required an annual PDMP check for controlled substance prescribing. Over 3.3M successful PDMP checks were executed through the Integrated PDMP Solution. This number is expected to grow with the participation and integration of California and Nebraska into the solution.

Finally, VA PDMP Integrated Solution plays a pivotal role in the VA's commitment to becoming a High Reliability Organization, addressing the ongoing US opioid epidemic, and equipping care providers with comprehensive patient information to enhance patient safety. Before the implementation of the VA PDMP Integrated Solution, clinicians had to access vital patient information by logging into one or more state portals via the internet. This manual and decentralized process was not only time-consuming but also prone to human error. Simply put, VA staff would have to return to the process that they had to follow before the VA PDMP Integrated Solution was deployed. Therefore, the PDMP integrated solution benefits all veterans, including those who require PDMP checks and those whose clinical decisions are enhanced by access to this valuable information. Selection of a new SaaS product would force our clinicians to return to manual processes and could impact patient safety, contribute to increased provider workload, and negatively affect trust in VA.

6. Efforts to Obtain Competition:

Market research was conducted, details of which are in Section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. However, the undersigned VA technical representative determined that limited competition is available among authorized resellers for brand name Bamboo Health PMP Gateway. In accordance with FAR 16.505(a)(4)(iii)(A)(1), this justification will be provided with the solicitation to all appropriate T4NG Prime Contract holders. Furthermore, in accordance with FAR 5.301, 16.505(b)(2)(ii)(D), and 16.505(a)(4)(iii), the award notice for this action will be synopsized on the Contract Opportunities website and this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition:

The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. Future competitive efforts are anticipated to start as early as FY25 for opportunities to replace the existing SaaS and determine if a replacement product would be feasible.

8. Market Research:

The Government’s technical experts conducted market research between January and February 2024 to ascertain if any other SaaS solution can meet VA’s needs. As of February 2024, VA technical experts reviewed SaaS solutions and services from RxCheck, LogiCoy PMPcentral, Leap Orbit RxGov PDMP. Based on reviews the Governement’s technical experts determined that none of these SaaS Solutions can meet the Government’s interoperability and compability requirements that were previously addressed in Section 5 of this justification. RxCheck, LogiCoy PMPcentral, and Leap Orbit RxGov PDMP cannot meet the requirements because the downstream products (eg: VDIF, VistA, CPRS, and associated dashboards) have been reconfigured, coded for redevelopment, and end-to-end tested. These technical modifications for a new solution would necessitate significant financial and schedule impacts for VHA’s critical PDMP solution which if impeded could lead to clinicians to return to manual processes and would degrade patient safety. Additionally, market research, as of February 2024, confirms that brand name Bamboo Health PMP Gateway can connect to 52 out of 54 PDMP databases, which no other integration solution can do at this time.

Additional market research was conducted in January 2024, wherein the Government’s technical experts utilized the Small Business Administration (SBA) Certification (VetCert) database (https://veterans.certify.sba.gov/) was reviewed on January 2024, and there were 4,573 matches under North American Industry Classification System code 541512, Compuer System Design Services. Furthermore, a Request for Information was conducted on January 3, 2024, on the Virtual Office of Acquisition (VOA) Acquisition Task Order Management System (ATOMS) where only one response was received from a T4NG SDVOSB vendor. An additional RFI was released in SAM.gov on January 11, 2024, where it closed with only one T4NG SDVOSB vendor response. As a result, the Government has determined that there are two SDVOB’s T4NG vendors that can use the brand name Bamboo Health PMP Gateway to sustain our VA PDMP Integrated Solution.

9. Other Facts:

None.