1 Health Care Vendor Relations A new UCOP Presidential Policy Lee Giddings, M.D. Chief Compliance Officer UCSD Health Sciences May 2008 Revised: 05/05/2008

2 Vendor Relations – Outline Introduction Background Key Elements Training Monitoring High Risk Areas Key Elements: I. Access II. Gifts III. Promotional Activity IV. Preceptorships V. Publicity of Support VI. Anti-Kickback Law

3 Vendor Relations – Introduction “Policy on Health Care Vendor Relations” (PP031208) Approved: Officially signed by President Dynes – Mar. 12, 2008 Implementation: July 1, 2008 Endorsed by: UC Academic Senate UC Chancellors UC Health Science Vice Chancellors Work Group: Representation from all Health Science campuses Chaired by Rory Jaffe, M.D., Executive Director, Medical Services

4 Vendor Relations – Introduction Definition: Health Care Vendor. A company or its representative or the agent of a company that either produces or markets drugs, devices, nutritional products, or other medical products or services. Scope: All UCSD Health Science workforce members, both on and off campus (unless specifically noted)

5 Vendor Relations – Background California Political Reform Act (CPRA) of 2001 Attempts to remove bias from product decisions Financial COI focus; does not eliminate all conflicts Purpose of UCOP Policy To manage the perceived potential for industry unduly influencing health care decisions Not a Conflict of Interest (COI) Policy Supplements existing UC policies* Initiative Supported by: AMC National Trends Evidence based literature (Brennan, JAMA 2006; 295 (4): ) Increased regulatory scrutiny * Business & Finance Bulletin, G-39; COI Policy; Clinic Sample Policy, MCP 321.7; Regulations for Sales Representatives, MCP 550.1

6 Vendor Relations – Key Elements I.Vendor Access Vendors must register & wear ID badge (VendorClear); (addresses patient confidentiality provisions) Vendors must have scheduled appointments Appointments in non-clinical areas only Can not access patient information without written consent Anticipated FAQs Vendor may enter patient care areas if:  Pre-registered and requested by a UC representative  Providing a specific health care support service  Servicing equipment  Or as a patient or member of the general public

7 Vendor Relations – Key Elements II.Vendor Gifts Prohibits gifts provided directly to individuals Definition of Gift: Anything of value (including compensation) without providing a service of equivalent or greater value in exchange. Examples of gifts: Free food, pens, notepads, supplies, books Free samples Free equipment Travel and lodging Paid attendance or registration fees for conferences

8 Vendor Relations – Key Elements II.Vendor Gifts - Anticipated FAQs: The following are not considered a gift: Honoraria at Fair Market Value for legitimate service Food, travel, admission fee while providing a service Prizes or competitive awards Items provided at a discount or free as part of a University contract or a research project Refreshments, non-cash nominal benefits and materials provided by the organizers of a professional meeting and available to all attendees.  Example: CME Conference tote bags

9 Vendor Relations – Key Elements II.Vendor Gifts Prohibits samples in all UCSDHS sites Prohibits samples for personal use Alternatives: Vendor may donate “samples” for UC’s free clinics  Product must be on the UCSDMC formulary  Product storage / distribution must adhere to regulatory requirements Vendor may donate “product” for evaluation or education purposes. The amount is restricted to the minimum necessary for the intended use. [Refer to MCP 405.1]

10 Vendor Relations – Key Elements II.Vendor Gifts Alternatives: Patient Assistance Programs available through the UCSDMC Pharmacy. Vendor may donate “funds” to support the mission of the University (education, research, patient care) Examples of Permitted Uses of Vendor Funds: -Educational meetings (non-CME) -Departmental Activities -Purchase of food -Purchase of travel -Fundraising activities -Grants * -Fellowships Vendor can NOT: -Select speakers -Control content -Select recipients -Attend meetings * Research grants from industry require 700-U form submission & IRB approval.

11 Vendor Relations – Key Elements II.Vendor Gifts “Donations” must comply with standards and procedures of: ACCME (or equivalent) UCSD Office of Continuing Medical Education (OCME) (whether or not educational credit is offered) UCSD Office of Gift Administration (OGA) UCSD Office of Contracts & Grants Administration (OCGA) UCSD Conflict of Interest Office (COI) California Political Reform Act

12 Vendor Relations – Key Elements III.Vendor Promotional Material & Activity Prohibits branded items with company logos in all UCSDHS sites Prohibits meals, snacks, beverages directly provided by a vendor in all UCSDHS sites Anticipated FAQs: Patient education materials which are branded and needed for unique patient education purposes may be used at the discretion of individual providers, but should be free of all product promotion and bias.

13 Vendor Relations – Key Elements IV.Vendor Preceptorships An educational program for vendor representative(s) Requires a written service agreement (Dean’s Office) & oversight by UCSD OCME Requires compliance with HIPAA Privacy Rules & patient consent in clinical areas Preceptorship must not provide a vendor with sales and marketing opportunities Anticipated FAQs: A vendor has the same access to official educational offerings of the University as other members of the general public.

14 Vendor Relations – Key Elements V.Publicity of Industry Support California Public Records Act  Provides that information about industry support of the University is a public record APM-025  Requires faculty to report annually time spent in outside professional activity (OPA), which becomes a public record VI.Anti-Kickback Law The Federal Anti-Kickback Statute prohibits the solicitation or receipt of anything of value in return for patient referrals or to induce such referrals which could potentially be reimbursed by a government payer.

15 Vendor Relations – Training Vendors Registration process with Medical Center Purchasing Department (VendorClear) Workforce Members Train-the-trainer Faculty / Staff meetings Web postings Educational bulletins, memos, FAQs Learning management system (LMS) modules

16 Vendor Relations – Monitoring Vendors Enforce ID badge requirement Exclude from UCSDHS sites for repeated violations Send written report of violations / actions to company Physicians Collaborate to build awareness / change culture Department Chair / physician leaders as champions & role models Managers Discard branded items and literature Notify Pharmacy to retrieve samples for disposal Prohibit vendor provided food; notify Purchasing of violations Committees Guidance and oversight by established UCSDHS Committees Enforcement Corrective actions in accordance with UCSD & HR policies 15

17 Vendor Relations – High Risk Areas Activities to avoid… Sham honoraria or sham consulting agreements Compensation should be an equivalent value for legitimate services Luxurious off-site meetings & meals Entertainment unrelated to educational goals Free trips and tickets Speakers bureau & ghostwriting Vendor control or influence of the content of a presentation is prohibited Off-Label promotion (marketing)

18 Vendor Relations – Safeguards Managing HC Industry Vendor Relationships Disclose – financial relationships to Purchasing, CME sponsor, audiences (learners) & patients Recuse – from product purchase decisions for 12 months Seek – advice from the UCSD Conflict of Interest Office and your personal attorney Ask – assess your comfort level with potential public exposure or scrutiny

19 Questions? Lee Giddings, M.D. Larry Friedman, M.D. Charles Daniels, Ph.D., R.Ph. Kathleen Naughton UCOP policy site: “Policy on Health Care Vendor Relations” Policy Issuance Letter – President Dynes (03/12/2008)