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
1
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
2
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
3
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)
4
Vendor Relations – Background

California Political Reform Act (CPRA) of 2001



Purpose of UCOP Policy


To manage the perceived potential for industry unduly influencing health
care decisions
Not a Conflict of Interest (COI) Policy


Attempts to remove bias from product decisions
Financial COI focus; does not eliminate all conflicts
Supplements existing UC policies*
Initiative Supported by:



AMC National Trends
Evidence based literature (Brennan, JAMA 2006; 295 (4):429-433)
Increased regulatory scrutiny
* Business & Finance Bulletin, G-39; COI Policy; Clinic Sample Policy, MCP 321.7;
Regulations for Sales Representatives, MCP 550.1
5
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
6
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
7
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
8
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]
9
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
10
* Research grants from industry require 700-U form submission & IRB approval.
Vendor Relations – Key Elements
II.
Vendor Gifts
“Donations” must comply with standards and
procedures of:



ACCME (or equivalent) http://www.accme.org/
UCSD Office of Continuing Medical Education (OCME)
(whether or not educational credit is offered)
http://cme.ucsd.edu/




UCSD Office of Gift Administration (OGA)
UCSD Office of Contracts & Grants Administration (OCGA)
UCSD Conflict of Interest Office (COI)
California Political Reform Act
11
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.
12
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.
13
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.
14
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
15
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
16
15
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)
17
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
18
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”

http://www.ucop.edu/ucophome/coordrev/policy/PP031208Policy.pdf

Policy Issuance Letter – President Dynes (03/12/2008)
http://www.ucop.edu/ucophome/coordrev/policy/PP031208.pdf

19