UM Shore Regional Health Conflict of Interest

Policy Number: R-09
Revised: 3/16
Supersedes: 4/13

View Conflict of Interest as a PDF

Background and Objective

In order to ensure that all relationships meet the highest professional standards, the Medical System requires employees and certain medical staff members fully disclose any financial relationship that may result in situations involving dual interests which might be interpreted as potential conflicts of interest.

Policy

This policy provides a process to disclose relationships or proposed relationships between the Medical System and themselves (other than the employment relationship with UMMS), an immediate family member, or an entity in which they or an immediate family member have a Financial Relationship, Management Function, or employment relationship (collectively Relationship).

Definitions

Industry Company

• Any company, including any subsidiary or affiliated entity, that has or is anticipated to have a direct contractual relationship with the Medical System
• Any company, including any subsidiary or affiliated entity, that manufactures or distributes a pharmaceutical product, biological product, medical device, medical equipment or medical supply whose use, provision or prescription is eligible for coverage by government reimbursement (i.e. Medicare, Medicaid). This includes any company that manufactures such covered product, regardless of whether or not the manufacture of medically-related products is its principal business or simply a minor portion of its business activities

Financial Relationship

• Any employment or consulting relationship
• Any commission-based payments (e.g., insurance broker)
• Total value of gifts that exceed $1000 in value per Industry Company on an annual basis:
• Total value of entertainment events that exceeds $1000 in value per Industry Company on an annual basis;
• Any compensation arrangement with any Industry Company (including any subsidiary or affiliate of an Industry Company);
• Stock or ownership interests in an Industry Company (including any subsidiary or affiliated entity) amounting to greater than a three percent (3%) ownership interest;
• Stock-options issued by an Industry Company, regardless of amount or present value; or
• Any other compensation, reimbursement, or remuneration arrangements with an Industry Company not otherwise described above

Management Relationship

•  Trustee, director, general manager, principal, officer or general partner

Immediate Family Member

Spouse, parents, children and siblings, whether by blood, marriage (e.g., in-laws or step family) or adoption, and any other person residing in the person completing the questionnaire’s home

1.0 Procedure for Internal Collection of Questionnaires

Attachment A has been provided as the approved standard questionnaire; however, alternate questionnaires can be used if approved by Corporate Compliance

1.1- Management Employees (Vice President and above)

1.1.1 - Annually, each July, each management employee will complete a Disclosure of Financial Relationships Questionnaire (Attachment A). The Medical System’s General Counsel Office will distribute the form via email

1.1.2- The General Counsel will provide any positive responses to the Chief Compliance Officer.

1.2- Physician Employees and Independent Physician Contractors (Not including Independent Medical Staff)

1.2.1 - Upon contract / hire and annually within the first quarter of the calendar year, each physician employee / independent contractor will complete a Disclosure of Financial Relationships Questionnaire (Attachment A)

1.2.2 - The Affiliate’s Chief Medical Officer or designee or, in the absence of a Chief Medical Officer, an individual designated by the Chief Executive Officer will annually provide any positive responses to the Medical System Chief Compliance Officer.

1.3- Supply Chain Procurement Committee Members

1.3.1-Upon initiation of a committee that will influence future contracting (e.g. joint replacement products), each member of the committee, including employees and independent medical staff, will complete a Disclosure of Financial Relationships. Questionnaire (Attachment A). If any other person is a member (e.g. someone from a minority owned entity), he/she will also complete the questionnaire.

1.3.2-The Medical System’s Vice President of Supply Chain Operations or designee will provide any positive responses to the Chief Compliance Officer.

1.4-Pharmaceuticals and Therapeutics (P&T) Committee Members Annually within the first quarter of the calendar year for the previous calendar year.

1.4.1-Annually, each Pharmaceuticals and Therapeutics (P&T) Committee member will complete a Disclosure of Financial Relationships Questionnaire (Attachment A).

1.4.2-The Affiliate’s Chief Medical Officer or designee, or in the absence of a Chief Medical Officer, an individual designated by the Chief Executive Officer will annually provide any positive responses to the Chief Compliance Officer.

1.5- Identify and evaluate any other internal committees responsible for purchasing decisions such as Capital Equipment Procurement Committee Members Upon initiation of new committees and /or annually within the first quarter of the calendar year for the previous calendar year.

1.5.1-Upon initiation of a committee that will influence future purchasing, each member of the committee, including employees and independent medical staff, will complete a Disclosure of Financial Relationships Questionnaire (Attachment A).

1.5.2- The Affiliate’s Chief Operating Officer or designee will annually provide any positive responses to the Chief Compliance Officer.

1.6- All Employees and other persons in above categories. An employee or others in any of the above categories will disclose any new Financial Relationships that may arise by completing Attachment A. Such disclosure will be sent to Corporate Compliance at compliance@umm.edu.

1.7-Hospital Board of Directors,For each hospital, the CEO or designee will collect Disclosure of Financial Relationship Questionnaires from members of the hospital’s Board of Directors.

2.0- Procedure for Internal Review

2.1- Physician Disclosures, When physician disclosures are received from any of the above collection areas,Corporate Compliance & Business Ethics Group will compare the disclosed information to the CMS Open Payments database for any medical device or pharmaceutical manufacturers.

2.1.1-For any physician with a total of more than $10,000 in the CMS Open Payments database Corporate Compliance will work with Affiliate executives to develop a management plan.

2.1.2- Other physicians deemed to have less significant relationship will also require a management plan.

2.2- Other Disclosures, When information is received regarding other persons from any of the above collection areas, Corporate Compliance & Business Ethics Group will review the information and work with the management of the area to determine if there is a significant relationship that will require a management plan.

2.3 Management Plans for Disclosed Financial Relationships, Management plans may include such options as:

2.3.1-Disclosure to patients

2.3.2-Disclosure to Purchasing Committees / formal recusal if decisions

2.3.3-Disclosure if authorship / speaking

2.3.4-Limitation of hours of activity

2.3.5-Formal approval required for new activity

2.3.6-Limitation of use of any School of Medicine title

2.3.7-Limitation on relationship with vendor

2.3.7.1-Protocols for use of the vendor established by MEC / committee (e.g. physician owned service in hospital)

2.3.7.2-No related persons as representatives / technicians

2.3.7.3-No employed persons as vendor representatives

2.3.7.4-Stocked versus vendor representative bringing device for each case

2.3.7.5-No relationship at all

2.3.8-Clinical research limitations

2.3.9-Medical necessity / clinical indicator reviews of use of device / medication

3.0- Procedure for External Disclosure

3.1- Health Services Cost Review Commission, The CEO or designee will submit any required information to the Maryland Health Services Cost Review Commission, per COMAR 10.37.01.06, which includes any director or officer conducting more than $10,000 of business with the relevant hospital, either directly or indirectly

3.2-External Auditors and other Regulatory Agencies, The Medical System’s Chief Compliance Officer will submit any required information to the external auditors for the Medical System, or any other regulatory agency

3.3-Supply Chain, All invitations for bids, requests for proposals and other invitations or solicitations for offers will include the following provision: Any vendor, supplier, or other contractor or any grantor must disclose any actual or potential transactions with any Medical System officer, director, employee, or member of the medical staff, as applicable, including family members. Transactions include offers of employment, gifts, trips, or other things with a total, accrued value of more than $1000. The disclosure must be made within five days of the transaction, whenever it occurs. Failure to comply with this provision is a material breach of agreement. At a minimum, Supply Chain will include a list of the physician committee members if applicable for the particular contracting process. The Medical System’s Vice President of Supply Chain Operations or designee will provide any positive responses to the Chief Compliance Officer.

4.0- DOFR Monitoring Process

It will be the responsibility of each Affiliate Compliance Officer to ensure that all individuals within categories II. A – E complete the DOFR questionnaire at least on an annual basis