ROWAN UNIVERSITY POLICY
Title: Responding to Suspected Violations of the Stark Law That Do Not Implicate the Anti- Kickback Statute
Subject: Office of Compliance & Corporate Integrity
Policy No: OCCI 2013:C09
Applies: RowanSOM
Issuing Authority: Rowan President & RowanSOM Dean
Responsible Authority: RowanSOM Chief Compliance & Privacy Officer & General Counsel
Originally Issued: Jan 24, 2013
Revisions: July 1, 2013
Reviewed: Jan 6,2014
I. PURPOSE
To ensure that the Related Healthcare Entities follow the Centers for Medicare and Medicaid Services' (CMS) Voluntary Self-Referral Disclosure Protocol (SRDP) when appropriate.
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. This policy applies to and should be read by employees of schools, departments and units that are a part of RowanSOM as well as employees of other departments that bill federal or state programs for healthcare goods or services ("Related Healthcare Entity" or "Related Healthcare Entities."). Employees of other University 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, should also read this policy.
III. APPLICABILITY
RowanSOM units and departments that bill federal or state programs for healthcare goods or services ("Related Healthcare Entity" or "Related Healthcare Entities") shall, when appropriate, follow the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) for reporting to CMS suspected violations of the federal Stark law as set forth in this policy.
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. CMS Voluntary Self-Referral Disclosure Protocol https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Downloads/6409_SRDP_Protocol.pdf OMB CONTROL NUMBER: 0938-1106
C. The Medicare and Medicaid Patient Protection Act of 1987, as amended, 42 U.S.C. §1320a-7b (the "Anti-kickback Statute"),
D. Stark Exceptions, 42 CFR §§ 411.350 – 411.389
E. Stark Law Section 1877 of the Social Security Act 42 U.S.C. 1395
F. Patient Protection and Affordable Care Act (the Affordable Care Act) (Publ. L. 111-148) F
G. Focus Arrangement Database
H. General Statement on Agreements with Referral Sources
I. Fair Market Valuation
J. Professional Services Policy
K. Purchasing Policy
L. Policy on Notification and Approval of Certain Contracts Awarded without Competitive Bids or Proposal
M. Engagement and Payment of Professional Services Provider Policy
N. Gratuities, Guests, Gifts and Use of University Resources
V. POLICY
As recommended by CMS, once it is determined by RowanSOM that an alleged violation of the Stark Law has occurred and it wishes to report this alleged violation under the SRDP, RowanSOM shall obtain and report the following information to CMS:
A. A statement describing why RowanSOM believes a violation of the Stark Law may have occurred, including a complete legal analysis of the application of the Stark Law to the conduct related to the alleged violation, as well as any self-referral exception that may apply to the conduct;
B. Describe the circumstances under which the disclosed matter was discovered, as well as, any immediate corrective action which has been taken to prevent the continuation of this alleged violation and/or any potential future violations;
C. Identifying information, including the name, address, national provider identification numbers, CMS Certification Number and Tax Identification Number of the disclosing RowanSOM entity;
D. A statement identifying whether the disclosing RowanSOM entity has a history of similar conduct or has any prior enforcement actions against it;
E. An indication of whether the disclosing RowanSOM entity has knowledge that the matter is under current inquiry by a government agency or contractor;
F. A description of the nature of the matter being disclosed, including the type of financial relationship(s), the parties involved, the specific time periods of potential noncompliance, the circumstances under which the disclosed matter was discovered, the type of designated health service claims at issue, the type of transaction or other conduct at issue and the names of individuals and entities believed to be implicated, along with an explanation of their roles;
G. A financial analysis, that states the amount that is actually or potentially due; describe the methodology for calculating the amount due; and summarize the auditing activity and documents upon which RowanSOM relied in calculating the total amount potentially due, itemized by year, including the "look back" period, (i.e. the time during which RowanSOM entity did not appear to be in Stark compliance.);
H. The steps RowanSOM has taken to refund any applicable claims as directed by the CIA;
I. A statement from RowanSOM certifying that the information provided is true and based on a good faith effort to resolve liability under the Stark law; and
J. The steps RowanSOM will be taking to make disclosures under the SRDP, both electronically and by mail.
By Direction of the President:
Signature on file
RowanSOM Chief Compliance and Privacy Officer