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1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin, MD - Chief Medical Officer Timothy Albertson, MD,MHP, PhD - Professor/Division Chief Garen Wintemute, MD,MHP – Professor, Emergency Medicine

1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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Page 1: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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UCDHS Vendor Relations Policy Development & Implementation

Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal CounselAllan Siefkin, MD - Chief Medical OfficerTimothy Albertson, MD,MHP, PhD - Professor/Division ChiefGaren Wintemute, MD,MHP – Professor, Emergency Medicine

Page 2: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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Our Goals for Sharing

Vendor Policy Development

Vendor Policy Implementation

Bumps in the Road

Where we are today

Best Practices – Campus Sharing & Q/A

Page 3: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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JAMA Article, P&T Committee (sub), Pharma Code

Systemwide start Medical Staff, P&T - whose decision was it to

extend the definition of “vendor” to include all, rather then just health care vendors.

Policy Rollout Industry Relations Committee (IRC)

development

Starting Points

Page 4: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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UCDHS Vendor Relations

Background on Development JAMA Article Pharma Code Dr. Wintemute’s interest/guts to move forward His foresight for soliciting Dr. Albertson for

assistance as the Chair of the P&T Committee P&T appoints a sub-committee for

recommendations

Page 5: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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P&T Sub-Committee

Important acknowledgement that ownership of the recommendations being made were done through a Medical Staff Committee

Vendor relations would apply to “all” vendors, not only health care related

Recognizing existing policies that covered COI, financial interest, preceptorships and manufacturer relations

Appointment of Dr. Albertson to the newly formed UCOP committee to develop systemwide vendor policy

Page 6: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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UCOP Vendor Committee

Early draft of the UCOP policy was used to initiate the UCDHS Vendor Policy.

P&T subcommittee recommendation to the Dean who codified the policy.

Presentation to Governing Body

UCDHS Vendor Relations Policy approved

Recognition that the success of this policy would require transparency and buy-in from the bottom-up.

Page 7: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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Policy Implementation Rollout

CMO/CCO, Allan Siefkin, MD committed to education

Peer Pressure – Evolutionary change from the bottom

Transparency and light on the subject

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Rollout CMO/CCO Plan

Six months prior to policy implementation the campaign began Periodic Email Notifications Education

Focus Groups- Medical Staff- Department Managers, Department CAO’s, Nursing- Individual Department Faculty/Resident Meetings- Marketing & Fundraising personnel- Early version of FAQ’s developed and distributed

Page 9: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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Important Notes

Transparency Peer pressure – Evolutionary change Concerns about implications for clinical

research and the need to maintain industry relationships to further science and funding

Page 10: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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System Developments/Components

P&T Committee Products and Standardization Committee Value Analysis Committee

Medical Staff Committee Collaborative committee with the hospital Emphasis on supply purchasing for the OR

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Concerns about the Vendor Relations Policy from Faculty, Residents and Staff

Food - need to budget or obtain unrestricted funds

Samples – Most had been removed due to stricter Joint Commission requirements Additional need for samples imposed a need

for policy requiring Pharmacy to receive and distribute

Recognized Pharma Patient Assistance Programs

No distribution to any individual

Page 12: 1 UCDHS Vendor Relations Policy Development & Implementation Teresa Porter, CHC - Chief Compliance Officer David Levine, JD - Legal Counsel Allan Siefkin,

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Supporting Mission

Care – Research Important reminder for faculty related to:

speakers’ bureaus compensation plan consulting/outside professional activities

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Recognized Need

Based on the number of questions to various sources throughout the institution

Need to coordinate Need to provide direct source Establish formal committee to address

questions about Vendor Policy implementation

Ability for physicians to “plug-in”

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Dean’s Recommendation Industry Relations

Committee Charge:o This committee is advisory to the Vice Chancellor of Human Health

Sciences and reports to the UCDHS Executive Compliance Committee to draft directives and review health system policy; provide resources and direction to faculty and administration; review annual faculty conflict of interest disclosure statements; review teaching, and professional service arrangements or proposals; and field questions and inquiries related to conflict of commitment, conflict of interest and vendor relations for faculty and staff.

o Conduct substantive review of issues presented. o Recommend changes or restrictions in the project and/or recommend

changes to manage, reduce or eliminate potential conflicts of interest. o Recommendation whether the grant, contract, or gift should be

accepted.o The committee will meet monthly and may conduct business outside of

regularly scheduled meetings when the Chair of the Committee deems necessary.

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Best for Last - Interactive Sharing

Open Sharing