ROWAN UNIVERSITY POLICY
Title: Responding to Suspected Violations of the Anti-Kickback Statute or for Stark Law Violations that Potentially Implicate the Anti-Kickback Statute
Subject: Office of Compliance & Corporate Integrity (OCCI)
Policy No: OCCI: 2013: C08
Applies: RowanSOM
Issuing Authority: Rowan President & RowanSOM Dean
Responsible Authority: RowanSOM Chief Compliance & Privacy Officer & General Counsel
Adopted: Jan 24, 2013
Amended: July 1, 2013
Reviewed: Jan 6, 2015
I. PURPOSE
To ensure that when considering "self-disclosure", schools, departments and units that are a part of RowanSOM that bill federal or state programs for patient goods or services ("Related Healthcare Entity" or "Related Healthcare Entities") follow the recommendations of the Office of Inspector General in the OIG's Self Disclosure Protocol:
II. ACCOUNTABILITY
Under the direction of the President, the Dean, General Counsel and the Chief Compliance and Privacy Officer shall ensure compliance with this policy. Schools, departments and units that are a part of Rowan School of Osteopathic Medicine (RowanSOM) that bill federal or state programs for healthcare goods or services ("Related Healthcare Entity" or "Related Healthcare Entities") shall, when appropriate, consider use of the HHS Office of the Inspector General Self-Disclosure Protocol for reporting to the OIG suspected violations of the federal Anti-kickback statute as set forth in this policy.
III. APPLICABILITY
This policy applies to and should be read by employees of the RowanSOM that bill federal or state programs for patient goods or services ("Related Healthcare Entity" or "Related Healthcare Entities") as well as other RowanSOM departments that support the Related Healthcare Entities in contracting for goods and services, including but not limited to Finance, University Procurement and the Office of the Senior Vice President and General Counsel.
IV. RELATED DOCUMENTS
A. Corporate Integrity Agreement dated September 25, 2009 between UMDNJ and the Office of Inspector General of the Department of Health and Human Services as amended by a Letter Agreement, UMDNJ-RowanSOM dated May 1, 2013 ("CIA").
B. The Medicare and Medicaid Patient Protection Act of 1987, as amended, 42 U.S.C. §1320a-7b (the "Anti-kickback Statute")
C. Stark Law Section 1877 of the Social Security Act 42 U.S.C. 1395
D. Stark Exceptions, 42 CFR §§ 411.350 – 411.389
E. April 17, 2013 OIG's Provider Self-Disclosure Protocolhttp://oig.hhs.gov/compliance/self-disclosure-info/files/Provider-Self-Disclosure-Protocol.pdf
F. Focus Arrangement Database
G. General Statement on Agreements with Referral Sources
H. Fair Market Valuation
I. Professional Services Policy
J. Purchasing Policy
K. Policy on Notification and Approval of Certain Contracts Awarded without Competitive Bids or Proposal
L. Engagement and Payment of Professional Services Provider Policy
M. Gratuities, Guests, Gifts and Use Of University Resources
N. Consulting or Other Personal Services, Intellectual Property, Honoraria and Other Miscellaneous Activities Policies and Procedures for Payment
O. Signatory Authority
V. POLICY
A. As recommended by the OIG, when RowanSOM has reasonable grounds to believe that a suspected violation of the Anti-Kickback Act of 1986 may have occurred and a disclosure should be made under the SDP, RowanSOM shall promptly:
B. The Disclosure Report will:
VI. ATTACHMENT
A. Attachment 1 – HYPERLINK
By Direction of the President:
Signature on File
__________________________________________
Rowan SOM Chief Compliance and Privacy Officer
ATTACHMENT 1
HYPERLINK
[i] In its Notice of Proposed Rulemaking, 77 Fed. Reg. 9179-9187 (February 16, 2012), the Centers for Medicare & Medicaid Services (CMS) proposes to suspend the obligation to report over payments under section 1128J (d) of the Act when OIG acknowledges receipt of a submission to the SDP, so long as the submission is timely made. CMS also proposes to suspend the obligation to return overpayments until a settlement agreement is entered into, or the provider or supplier withdraws or is removed from the SDP. As necessary, we will provide additional guidance on OIG’s web site concerning section 1128J of the Act and the SDP after CMS issues its final rule.