Responding to Suspected Violations of the Anti-Kickback Statute or for Stark Law Violations that Potentially Implicate the Anti-Kickback Statute

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 7, 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:

• • When there are suspected violations of the Anti-kickback statue and Stark law violations that potentially implicate the Anti-kickback statute and
  • To possibly mitigate potential exposure under section 1128J(d) of the Act, 42 U.S.C. 1320a-7k(d). Section 1128J(d)(2) of the Act requires that a Medicare or Medicaid overpayment be reported and returned by the later of (1) the date that is 60 days after the date on which the overpayment was identified or (2) the date any corresponding cost report is due, if applicable. Any overpayment retained by a "person," as defined in section 1128J(d)(4)(C) of the Act after this deadline may create liability under the Civil Monetary Penalties Law (CMPL), section 1128A of the Act, and the False Claims Act (FCA), 31 U.S.C. 3729.Penalties Law (CMPL), section 1128A of the Act, and the False Claims Act (FCA), 31 U.S.C. 3729. ^[i]

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:

1. Report to the OIG, by writing an introductory letter to notify the OIG of RowanSOM's intention to voluntarily disclose the suspected violation. The letter will identify that RowanSOM is the disclosing provider and provide a general description of the suspected violation.
2. After the initial disclosure to the OIG, RowanSOM will conduct an internal investigation and a self-assessment of the financial impact of the suspected violation(s) and report the findings to the OIG as directed by RowanSOM's Corporate Integrity Agreement (CIA) and refund applicable claims per RowanSOM policy.
3. RowanSOM will also submit to the OIG a work plan describing RowanSOM's self- assessment process, and a Disclosure Report addressing the nature and scope of the non-compliance and why RowanSOM believes there is a potential violation.

B. The Disclosure Report will:

1. Identify the potential causes of the suspected violation;
2. Describe the suspected violation and/or practice in detail, including how the suspected violation and/or practice arose and continued;
3. Identify the School, Unit, Department(s), or related entities involved or affected;
4. Identify the impact on, and risks to, health, safety, or quality of care posed by the matter disclosed with sufficient information to allow the OIG to assess the immediacy of the impact and risks, the steps that should be taken to address them, as well as-the measures taken by RowanSOM;
5. Delineate the period during which the suspected violation and/or practice occurred;
6. Identify RowanSOM officials, employees or agents who knew of, encouraged, or participated in, the suspected violation and/or practice and any individuals who may have been involved in detecting the matter;
7. Identify RowanSOM officials; employees or agents who should have known of, but failed to detect, the suspected violation and/or practice based on their job responsibilities;
8. Estimate the monetary impact of the incident or practice upon the federal health care programs, pursuant to the self-assessment guidelines;
9. Relate the circumstances under which the suspected violation was discovered;
10. List the measures RowanSOM has taken to address the suspected violation and prevent future violations;
11. Include a list of all individuals interviewed in connection with the suspected violation;
12. Include a description of files, documents and records reviewed in connection with the suspected
13. violation;
14. Include a summary of auditing activities and a summary of documents relied upon in support of the estimation of losses; and
15. Include a "Certification of Truthfulness" signed by the person who is responsible for reporting the suspected violation to the OIG.

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.