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UNIVERSITY POLICY
SUBJECT:
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ADMINISTRATION
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TITLE:
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DISCLOSURE TO FEDERAL ENFORCEMENT AUTHORITIES
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CODING: |
00-01-10-155:00 |
ADOPTED: |
01/16/07 |
AMENDED: |
01/16/07 |
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LAST REVIEWED: 01 /16/07
To establish a policy for identifying potential Reportable Events as required in the Deferred Prosecution Agreement and disclosing information about actual Reportable Events to the appropriate legal authorities, including the Monitor and the U.S. Attorney, as defined below.
II. ACCOUNTABILITY
Under the direction of the President, the Executive Vice President for Academic and Clinical Affairs, the Senior Vice Presidents, the Vice President and University Chief of Staff, the Vice President/Chief Ethics & Compliance Officer, and the Vice President for Legal Management shall ensure compliance with this policy. The Deans, Vice Presidents, President/CEOs of the Healthcare Units, and University Hospital Medical Director shall implement this policy.
III. APPLICABILITY
This policy shall apply to all trustees, officers, faculty, housestaff, attending physicians and staff members of the University, volunteers, and students (including postdoctoral fellows) when performing functions under the authority of, or acting on behalf of, the University.
IV. DEFINITIONS
A. U.S. Attorney - The United States Attorney for the District of New Jersey, other attorneys within the Office of the United States Attorney for the District of New Jersey, their successors or designees.
B. Monitor - The Honorable Herbert J. Stern, appointed by the U.S. Attorney as the Federal Monitor under the Deferred Prosecution Agreement, the firm of Stern & Kilcullen, and any of its attorneys, Sobel & Co., or any of their agents, successors or assigns.
C. Deferred Prosecution Agreement - The Agreement entered into between the University of Medicine and Dentistry of New Jersey and the Office of the United States Attorney of the District of New Jersey on or about December 30, 2005.
D. Reportable Event:
1. any matter which would reasonably be considered a potential violation of any criminal, civil, or administrative statute or regulation applicable to any Federal health care program for which criminal penalties, civil monetary penalties, or exclusion may be authorized. This includes, but is not limited to, violations of Stark regulations and the Anti-Kickback Act; or
2. any other incident of unlawful conduct or serious wrongdoing that is not directly applicable to the categories mentioned in above subparagraph (1); nor related to academic affairs.
V. REFERENCES
A. Deferred Prosecution Agreement
http://www.umdnj.edu/about/board/DFAFinalsigned.pdfB. Reporting Compliance and Ethics Concerns 00-01-15-55:00
VI. POLICY
A. Disclosure Obligations:
1. The University of Medicine and Dentistry of New Jersey, in order to assure full compliance with the Deferred Prosecution Agreement, shall implement this policy and appropriate procedures including designating those individuals responsible for receiving the notifications and providing information, as necessary, to ensure that disclosures to the Monitor, to the U. S. Attorney and to other federal enforcement authorities are made in a manner consistent with paragraph 9 of the Deferred Prosecution Agreement. This requires the University to notify the Monitor and the U.S. Attorney (referred to in the Deferred Prosecution Agreement as the “Office”) in writing of “any allegations of unlawful conduct or other wrongdoing by UMDNJ, its trustees, officers, employees and agents” and to “provide the Monitor and the Office with all relevant documents and information concerning such allegations.”
2. This requirement for the University to report such allegations shall not preclude any UMDNJ employee from exercising his or her right to directly report any allegations of unlawful conduct directly to either the Monitor or the U.S. Attorney.
B. Disclosure Procedure:
1. UMDNJ will disclose to both the Monitor and to the U.S. Attorney all Reportable Events related to compliance, including laws and regulations governing participation in Federal healthcare programs.
2. Such disclosure to the U.S. Attorney shall primarily be the responsibility of the Vice President/Chief Ethics & Compliance Officer and disclosure to the Monitor shall primarily be the responsibility of the Vice President and University Chief of Staff or their designees.
3. Any person to whom this policy applies, who becomes aware of an allegation of unlawful activity, wrongful conduct or any other Reportable Events, should immediately notify the Vice President/Chief Ethics and Compliance Officer, the Vice President and University Chief of Staff or the Vice President, Legal Management with information about such allegations, in order to permit appropriate and effective disclosure of such information to the Monitor or the U.S. Attorney. Any documents, whether in paper, electronic or other formats, should also be forwarded, along with any information about the allegations.
4. The disclosure shall be in the form of a letter or a memorandum, or electronic communication, written to the Monitor and the U.S. Attorney, which shall contain:
a. a description of the relevant facts concerning the Reportable Event and any Federal health care program programs implicated;
b. the source of information about the Reportable Event, if available;
c. a summary description of actions taken to correct the potential Reportable Event;
d. a description of any further action planned to address and remediate the potential Reportable Event; and copies of any relevant materials relating to the Reportable Event.
By Direction of the President:
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Vice President and University Chief of Staff
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Vice President/Chief Ethics & Compliance Officer