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ROWAN UNIVERSITY POLICY

Title: Focused Arrangement Database Policy & Approval Process
Subject: Office of Compliance & Corporate Integrity (OCCI)
Policy No: OCCI: 2013: C03
Applies: RowanSOM
Issuing Authority: Rowan President & RowanSOM Dean
Responsible Authority: RowanSOM Chief Compliance and Privacy Officer
Adopted: 05/12/2009
Reviewed: 07/02/2012
Amended: 07/01/2013
Last Reviewed: 12/30/2014

I. PURPOSE

A. To set forth the general guidelines for the submission, approval and administration of all contractual agreements entered into by Rowan University School of Medicine (RowanSOM) which constitute Focus Arrangement (as defined below) under the terms of the Corporate Integrity Agreement ("CIA") dated September 25, 2009 between UMDNJ and the Office of Inspector General of the Department of Health and Human Services.

B. To establish procedures to activate and maintain a Focus Arrangements database through Rowan SOM electronic contract management system.

II. ACCOUNTABILITY

Under the direction of the President, the Dean, General Counsel and the Chief Compliance and Privacy Officer are to ensure compliance with this policy and the terms of the CIA. The deans, department chairs and chief executive officers shall implement this policy.

III. APPLICABILITY

This policy applies to all RowanSOM operating units, including but not limited to hospitals, physician practices, and outpatient centers.

IV. DEFINITIONS

A. "Arrangements" - every arrangement or transaction that:

  1.  Involves, directly or indirectly, the offer, payment, solicitation, or receipt of anything of value; and is between RowanSOM and any actual or potential source of health care business or referrals to RowanSOM or any actual or potential recipient of health care business or referrals from RowanSOM. The term "source" shall mean any physician, contractor, vendor, or agent; and the term "health care business or referrals" shall be read to include referring, recommending, arranging for, ordering, leasing or purchasing of any good, facility, item, or service for which payment may be made in whole or in part by a Federal health care program; or
  2. Is between RowanSOM and a physician (or a physician's immediate family member as defined at 42 C.F.R. §411.351)) who makes a referral (as defined at 47 U.S.C. §1395nn(h)(5)) to RowanSOM for designated health services (as defined at 42 U.S.C. §1395nn(h)(6)).

B. "Focus Arrangement" - every arrangement or transaction that:

  1. Involves directly or indirectly, the offer or payment of anything of value and is between RowanSOM and any actual source of health care business or referrals to RowanSOM; or
  2. Between RowanSOM and a physician (or a physician's immediate family member (as defined at 42 C.F.R. §411.351)) who makes a referral (as defined at 42 U.S.C. §1395nn(h)(5)) to RowanSOM for designated health services (as defined at 42 U.S.C. §1395nn(h)(6)).
  3. The following shall not be considered Focus Arrangements for purposes of the CIA: any Arrangement that satisfies the requirements of 42 C.F.R. 411.356 (ownership of investment interests), 42 C.F.R. 411.457(g) (remuneration unrelated to the provision of designated health services), 42 C.F.R. 411.357(i) (payments by a physician for items and services), 42 C.F.R. 411.357(m) (medical staff incidental benefits), 42 C.F.R. 411.357(o) (compliance training), 42 C.F.R. 411.357(q) (referral services), 42 C.F.R. 411.357(s) (professional courtesy), 42 C.F.R. 411.357(u) (community-wide health information systems), or any exception to the prohibition of 42 U.S.C. 1395nn enacted following the CIA Effective Date which does not require a written agreement.

C. "Covered Persons" - include:

  1. All officers, trustees, and employees of RowanSOM (excluding housekeeping, maintenance, and food service employees); and
  2. All contractors, subcontractors, agents and other persons who provide patient care items or services or who perform billing or coding functions on behalf of Rowan SOM excluding vendors whose sole connection with RowanSOM is selling or otherwise providing medical supplies or equipment to RowanSOM and who do not bill the Federal health care programs for such medical supplies or equipment; and
  3. RowanSOM employed medical staff.
  4. Covered Persons does not include part-time or per diem employees, contractors, subcontractors, agents or other persons who are not reasonably expected to work more than 160 hours per year, except that any such individuals shall become Covered Persons at the point when they work more than 160 hours during the calendar year.

D. "Arrangements Covered Persons" - includes each Covered Person involved with the development, approval, management, or review of RowanSOM Arrangements.

E. "Database or Contract Management System" - is the electronic contract management system, authorized by the Senior Vice President and General Counsel to process, execute, and store all arrangements and focused arrangements entered into on behalf of RowanSOM.

V. REFERENCES

A. 42 U.S.C. § 1320a-7b; 42 C.F.R. § 1001.952(a)-(v); 42 U.S.C. § 1395nn; 42 C. F. R. § 411.350 et. seq.;

B. 60 Fed. Reg. 41914 (Aug. 14, 1995); 63 Fed. Reg. 1659 (Jan. 9, 1998);

C.66 Fed. Reg. 856 (Jan. 4 2001); 69 Fed. Reg. 16054 (March 26, 2004); Corporate Integrity Agreement Between the Office of Inspector General of the Department of Health and Human Services and the University of Medicine and Dentistry of New Jersey, September 25, 2009.

D. Contract Management

VI. POLICY

A. All Focus Arrangements shall be compliant with the requirements of the CIA. All Focus Arrangements must be reviewed and approved by the applicable dean, chief executive officer and RowanSOM legal counsel prior to execution, and stored in the Focus Arrangement section of RowanSOM electronic contract management system after execution, in accordance with this policy.

B. The President, General Counsel and the Compliance Officer, will develop procedures to review all existing arrangements for compliance with the requirements of the CIA. Such procedures will include a review of existing arrangements over a period of time, not to exceed 120 days from the CIA Effective Date, in order to determine whether existing arrangements are Focus Arrangements.

 C. Focus Arrangements Approval and Review Procedure (New or Renewed Arrangements)

The department chairs, deans and chief executive officers are responsible to comply with the following requirements:

  1. The Focus Arrangement must be set forth in a written agreement and be reviewed by the applicable dean, chief executive officer, unit compliance officer and Rowan SOM legal counsel.
  2. The written agreement must contain a provision requiring that all individuals who meet the definition of an Arrangements Covered Person to comply with RowanSOM Compliance Program, including the training related to the Anti-Kickback Statute and the Stark Law
  3. The written agreement must have a certification by each party stating that each party will not violate the Anti-Kickback Statue and/or Stark Law with respect to performance of the contract.
  4. All parties to the Focus Arrangement must be given a copy of RowanSOM Code of Conduct and Compliance Policies and Procedures that pertain to the Anti-Kickback and Statute and the Stark Law.
  5. The department chairs, deans and chief executive officers shall ensure that each Focus Arrangement is entered into the Focus Arrangement Database following execution.

D. Database Requirements for Focus Arrangements Agreements

Each executed Focus Arrangement shall be entered promptly into the Focus Arrangements section of RowanSOM electronic contract management system; for each Focus Arrangement included in the contract management system, the following information shall be recorded:

  1. Each party involved in the Focus Arrangement;
  2. The type of Focus Arrangement (e.g., physician employment contract, medical directorship, lease agreement);
  3. The term of the Focus Arrangement, including the effective and expiration dates and any automatic renewal provisions;
  4. The amount of compensation to be paid pursuant to the Focus Arrangement and the means by which compensation is paid;
  5. The methodology for determining the compensation under the Focus Arrangement, including the methodology used to determine the fair market value of such compensation; and an attestation by the compliance officer that he/she finds the FMV analysis methodology reasonable for the arrangement.
  6. Whether the amount of compensation to be paid pursuant to the Focus Arrangement is determined based on the volume or value of referrals between the parties;
  7. Whether each party has fulfilled the requirements of Section III.D.2 of the CIA which shall include:
    1. ensuring that each Focus Arrangement is set forth in writing for a minimum of one year and signed by RowanSOM and the other parties to the Focus Arrangement;
    2. in the written agreement a requirement that all individuals who meet the definition of Arrangements Covered Persons shall comply with RowanSOM Compliance Program, including the training related to the Anti-Kickback Statute and the Stark Law; additionally it must be documented in the contract that RowanSOM has provided each party to the Focus Arrangement with a copy of its Code of Conduct and Stark Law and Anti-kickback Statute Policies and Procedures; and
    3. in each written Focus Arrangement a certification by the parties to the Focus Arrangement that the parties shall not violate the Anti-Kickback Statute and the Stark Law with respect to the performance of the Focus Arrangement.
  8. Whether the Arrangement satisfies the requirements of an Anti-Kickback safe harbor and/or a Stark Law exception or a safe harbor, as applicable.

E. Focus Arrangements Requirements: Non-contractual transactions involving non-monetary compensation

With respect to Focus Arrangements that constitute non-monetary compensation pursuant to 42 C.F.R. 411.357(k), the following information shall be recorded:

  1. Each party involved in the Focus Arrangement;
  2. The type of Focus Arrangement (e.g., the type of non-contractual transaction);
  3. The aggregate value of all non-contractual transactions with each entity or individual during the Reporting Period;
  4. Whether the amount of compensation to be paid pursuant to the Focus Arrangement is determined based on the volume or value or referrals between the parties; and
  5. Whether the Focus Arrangement satisfies the requirements of an Anti-Kickback Statute safe harbor and/or a Stark Law exception or safe harbor, as applicable.

F. On a quarterly basis during the term of the CIA, the Compliance Officer will review the Focus Arrangements section of RowanSOM electronic contract management system and the internal review and approval processes related to Focus Arrangements, and provide a quarterly certification of Compliance report containing the results of the review to the Compliance Committee.

G. In accordance with the requirements of the CIA, RowanSOM will retain and make available to the OIG, upon request, the Focus Arrangements section of the Database and all supporting documentation of the Arrangements subject to this policy and the Focus Arrangements Approval Procedure, and, to the extent available, all non-privileged communications related to the Focus Arrangements and the actual performance of the duties under the Focus Arrangements.





By Direction of the President:

Signature on file
RowanSOM Chief Compliance and Privacy Officer

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