UPMC POLICY AND PROCEDURE MANUAL

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1 SUBJECT: Value Analysis Program DATE: November 8, 2013 I. POLICY UPMC POLICY AND PROCEDURE MANUAL POLICY: HS-MM0302 * INDEX TITLE: Supply Chain Management It is the policy of UPMC to provide a single, system-wide Value Analysis process that is multi-disciplinary in nature with representation including nursing, physicians, administration, and Supply Chain Management. Team members are empowered supported and held accountable by UPMC senior administration to identify opportunities, make product standardization and utilization decisions, oversee implementation efforts and communication, and meet the UPMC financial goals. At the recommendation of the appropriate Value Analysis Team, or duly appointed representative, the Supply Chain Management Department, subject to the oversight of the Value Analysis Executive Steering Team, shall make commitments for evaluations of products for department use in both the clinical or non-clinical product area. Links to policies referenced within this policy can be found in Section VI. II. SCOPE This policy applies to all United States based UPMC entities and locations. III. PURPOSE The Value Analysis Program convenes users who have subject matter expertise, financial analysts, and those with Supply Chain Management expertise, in order to make the bestvalue product and service decisions. IV. PROCEDURE A. Mission Statement The Value Analysis Program, through the Value Analysis Executive Steering Team, Technology and Innovative Practice Advisory Committee (TIPAC), and Specialty Sub-Committees (Value Analysis Teams) shall ensure the preservation and improvement of the quality of patient care while controlling costs and risks related to the purchase and use of products and services.

2 PAGE 2 B. Review Criteria 1. FDA Class 3 medical devices must be evaluated via the Value Analysis process. 2. Non-Class 3 products do not require a review if they meet any of the following conditions: a. Product has a unit cost of less than $100 b. Product is reasonably expected to be low volume in use c. Product is under active contract from an approved vendor review. C. Structure of the Value Analysis process 1. The Value Analysis Executive Steering Team is comprised of senior leaders and chairpersons from the UPMC system and the UPMC Supply Chain Management department. This Team will provide oversight of the overall Value Analysis process. TIPAC and Specialty Sub-Committees (Value Analysis Teams) will report progress to the Value Analysis Executive Steering Team. 2. The Value Analysis Teams are comprised of representatives from the various campuses functional departments. The membership will be active clinicians representing a service area (physicians, nurses, and ancillary staff) and representatives from Supply Chain Management. These groups will elect a chairperson. These groups will communicate their activity to the Value Analysis Executive Steering Team as well as the stakeholders from their respective campus, business unit or operating division. They are also charged with identifying opportunities, reporting outcomes, making final decisions, implementing changes and tracking and actualizing initiatives. 3. TIPAC is a unique Value Analysis Team tasked with reviewing any new clinical technology, inclusive of but not limited to any technology submitted to the FDA under its own PMA, as well as any innovative or off-label practice that has the potential to increase UPMC s enterprise spend by more than $50K annually; no new technology or innovative practice should be authorized for system use without approval of the TIPAC. The TIPAC members shall include senior leaders and chairpersons from Physician Services, the IRB, Finance, Hospital Operations, Corporate Legal, and Supply Chain Management. 4. Membership and meeting attendance information will be formally documented and made available to each business unit upon formal written request.

3 PAGE 3 5. The Value Analysis Executive Steering Team will review certain issues that may arise as a result of a change in product that was initiated by one of the Value Analysis Teams. The Value Analysis Executive Steering Team will not be required to review all decisions, but rather retains the right to review and under special circumstances overturn decisions made by the individual Value Analysis Teams when doing so is in the best interest of UPMC and its patient population. This ensures that the process has a review of the products and utilization enhancements that are made. It also provides an independent review process of the program initiatives. D. Value Analysis guiding principles Vision Statement: The Value Analysis process will be responsible for directing a clinically driven, financially responsible product selection process. Clinical evaluations will be utilized when appropriate for new product introductions or for products not currently utilized by any of the UPMC System entities. Clinical outcomes will be weighed against the financial impact as part of the selection process. All products and services must meet the needs of UPMC but will not exceed the needs. Product selections must be clinically acceptable or acceptable to the user in non-clinical situations as well, while providing the optimal life cycle cost option for the system. Product selection will follow a defined process that engages both clinical personnel, physicians, and sourcing personnel from Supply Chain Management to help ensure the balance between clinical quality concerns and cost effectiveness. Operational Role: The role of the Value Analysis Program is to implement and facilitate a single, system-wide, product value analysis process. This process will be guided by the following principles: The Value Analysis Team will ensure that the Specialty Sub-Committees evaluate products and base decisions on sound clinical evaluations. The Value Analysis Team will be free from conflict or, where not practical or possible, all conflicts will be disclosed, documented and formally mitigated. Product changes must meet criteria established by the Value Analysis Executive Steering Team or Specialty Sub-Committees. The Value Analysis Teams and the Supply Chain Management department will provide reports to the Value Analysis Executive Steering Team to ensure the clinical and administrative leadership of all entities are informed about the activities of the various Specialty Sub-Committees.

4 PAGE 4 The Value Analysis Executive Steering Team will ensure that the product selections are in the best interest of the patients of UPMC. This means that the selection process must provide products that are in the best interest of the UPMC patient population while providing overall cost savings to UPMC. The Value Analysis Executive Steering Team will provide a source of COI management and issue resolution for the Value Analysis Teams and their members. The Value Analysis Executive Steering Team will meet as needed to ensure the Specialty Sub-Committees are meeting the time and dollar commitments they ve made. Process compliance will be enforced by a three tier escalation process: Level 1: department manager/director will receive a verbal communication form the Value analysis manager or designee that describes the infraction. Level 2: department manager/director will receive a written communication which requires a response for the infraction involved. This behavior will be reported to the Executive Steering Team. Level 3: Official Notification to the CEO of the noncompliant facility from the Executive Steering Team. E. Committee Member Responsibilities Each member represents the areas, at every meeting, for which he or she has been assigned responsibility, acts as a liaison, contributes to the decision-making process of the Team, and presents to the Team all requests for product evaluation and results on new product evaluations. Each member is responsible for communicating information from meetings to facility stakeholders and identifying key stakeholders in evaluation processes. Each member is responsible for meeting deadlines and fulfilling the obligations of task forces which he or she may be assigned to chair. Conflict of Interest process All Value Analysis Team members must complete a conflict of interest document, in accordance with the UPMC HS-EC1700 Conflict of Interest General Obligations policy, annually, as well as comply with all requirements contained within the policy to remain an active participant in the process.

5 PAGE 5 In July of each year and upon the addition of a new member, the Senior Manager of Value Analysis (or their delegate) will provide a roster of all Value Analysis Team Members to the Manager of Compliance, UPMC Corporate Compliance, for conflict review using the UPMC Watchlist. In the event that a given VAT member is shown to have a business relationship within the UPMC Watchlist, the Manager of Compliance will list the name of the affected team member and the team(s) on which they participate and forward them to the UPMC Senior Manager of Value Analysis with a recommended conflict management plan. Should the UPMC Manager of Compliance conclude that the conflict is significant enough to warrant removal of the VAT member or a restriction of their voting rights, they will schedule a meeting with the Vice President of Clinical Sourcing to discuss a mutually acceptable conflict management plan. At the commencement of each VAT meeting, included with the review and approval of the minutes, the VAT Supply Chain Facilitator will ask the VAT members if they have any additional disclosures to report (per their obligation under UPMC HS-EC1700 Conflict of Interest). Each member who answers affirmatively will be listed in the minutes of the meeting in a standard section of the minutes reserved for updated disclosures. The Manager of UPMC Corporate Compliance will be given access to the VAT Sharepoint in order to facilitate a review of the meeting minutes. The Manager of Compliance will use the minutes to insure that any VAT member noting an updated disclosure has updated the COI database. Should a VAT decide to include an additional disclosure method or frequency within a given VAT, the Senior Manager of Value Analysis (or their delegate) will record the additional information in the VAT minutes and provide it to the UPMC Compliance Manager. The UPMC Compliance Manager will coordinate the process required to affect a timely update of the UPMC Watchlist and other appropriate applications. V. DESIRED STATE A single, System-wide Value Analysis process that is multi-disciplinary in nature with representation including nursing, physicians, administration, materials management, and Supply Chain Management. Team members and leadership are empowered, supported and held accountable by UPMC senior administration to identify opportunities, make product standardization and utilization decisions, oversee implementation efforts and communication, and meet the project s financial goals. The Value Analysis process is distinguished by the following operating characteristics: Clearly defined lines of accountability and authority;

6 PAGE 6 New product evaluation and selection will follow a defined process that engages both the clinical personnel, physicians, and sourcing personnel from Supply Chain Management to help ensure the balance between clinical quality concerns and cost effectiveness; Strong medical and clinical leadership in establishing product specifications / requirements and utilization patterns; Standardized clinical products and equipment where appropriate; Balance of clinical quality concerns and increased staff awareness and accountability for supply costs; Appropriate communication and/or education prior to product conversions; Protocols and tools to evaluate new and existing medical products to help ensure the balance between clinical quality concerns and cost effectiveness; System-wide financial monitoring tool to measure savings and utilization; Supply Chain Management is responsible for product/practice research, data collection and analysis, benchmarking, and results reporting; Clinically-focused Value Analysis Teams convened as needed to identify and implement specific cost savings. They are responsible for product/practice research, data collection and analysis, benchmarking, and results reporting; and Integrated supply management as a component of the care management process (supply management and medical management efforts need to be coordinated as they relate to product line/clinical pathway development). Unbiased, transparent decision-making. VI. POLICIES REFERENCED WITHIN THIS POLICY: HS-EC1700 Conflict of Interest General Obligations SIGNED: James Szilagy Chief Supply Chain Officer ORIGINAL: October 1, 1999 APPROVALS: Policy Review Subcommittee: October 10, 2013 Executive Staff: November 8, 2013 PRECEDE: July 27, 2012 SPONSOR: Vice President(s), Supply Chain Management * With respect to UPMC business units described in the Scope section, this policy is intended to replace individual business unit policies covering the same subject matter. In-Scope business unit policies covering the same subject matter should be pulled from all manuals.