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Corporate Integrity Agreements: OIG Provides Glimpse of the Future

The OIG held a roundtable meeting with representatives from 32 companies that have entered into Corporate Integrity Agreements (CIAs) since 2009. Following from the August 7, 2012, roundtable meeting, this week the OIG published a roundtable paper Focus on Compliance: The Next Generation of Corporate Integrity Agreements.  The roundtable paper summarizes the roundtable discussions and provides guidance to companies that are negotiating CIAs.

Several requirements included in most, if not all, CIAs formed the topics of the roundtable meeting:  (1) the definitions of “covered persons” and “relevant covered persons;” (2) codes of conduct, compliance policies and procedures, and training and education; (3) the role of the compliance officer, internal auditing and audit plans, and the role of the board of directors; (4) claims review requirements; and (5) arrangements review requirements.

The roundtable paper summarizes each requirement and feedback from representatives of companies that have entered into CIAs about their experiences in connection with their efforts to implement the CIA requirements.  The OIG has indicated that it will consider the feedback when deciding what terms to include in future CIAs.  Therefore, companies can consider the issues and recommendations discussed in the roundtable paper when negotiating their own CIAs.  The roundtable paper offers a number of potential negotiation points for companies that are involved in CIA negotiations.

  • Requirement:  Provide training on the compliance program and the CIA to all “covered persons,” which includes all employees, and on defined subject areas to all “relevant covered persons,” which includes those employees and contractors who provide patient care or who are involved in coding or billing for health care items or services.
    • During CIA negotiations, discuss the company’s business model with OIG and tailor the definitions of covered persons and relevant covered persons.
    • Limit the definitions of covered persons and relevant covered persons to those individuals involved in the type of conduct that led to the CIA.
  • Requirement:  Adopt and implement a code of conduct setting forth the company’s commitment to compliance and the importance of adhering to Federal health care program requirements and related policies and procedures.
    • Instead of requiring the company to distribute the code of conduct and obtain certifications each time revisions are made, permit the company to make revisions and obtain certifications during annual general training, as long as current versions of the code of conduct are posted and accessible electronically.
    • Permit the company to identify its own annual training topics.
    • Eliminate the requirements that covered persons and relevant covered persons receive a minimum number of hours of annual training; focus on whether the training program thoroughly addresses the topics specified in the CIA.
  • Requirement:  Appoint a compliance officer to be responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the CIA and Federal health care program requirements.
    • Include resource allocation requirements in the CIA.
    • Require the compliance officer to report directly to the company’s governing board, and not to the general counsel or chief financial officer, and to be a member of senior management.
  • Requirement:  Governing board receives training and reports from the compliance officer, and passes an annual resolution certifying to the board’s oversight of the compliance program.
    • Maintain board responsibilities, including certifications; results in more engaged board members and the allocation of resources because the board feels a responsibility to mitigate risk.
    • Independent Review Organizations (IROs) should report directly to the board.
  • Requirement:  Conduct a discovery sample of 50 paid Medicare claims from those submitted during a specified 12-month period.  If the net financial error rate for the discovery sample is 5 percent or greater, conduct a review of additional claims and a systems review.  Engage an IRO to conduct an annual claims review.
    • Increase the sample size and focus the claims review on particular types of claims or issues.
    • Allow company to conduct its audits internally and have the results verified by the IRO.
  • Requirement:  Implement procedures to ensure that existing and new arrangements do not violate the Anti-Kickback Statute or the Stark Law.  Create a centralized tracking system, track payments made, track the services provided or the space/items leased, and implement a written review and approval process that includes a legal and business review, with a process for determining the fair market value of the payments made.  Engage an IRO to perform a review of these procedures and arrangements.
    • Define arrangements by tailoring the review to the company type or industry sector; have different review processes for the businesses with which company primarily contracts.
    • Narrowly tailor the scope of arrangements to reflect the covered conduct within the settlement agreement.
    • Define the scope of the IRO review and allow flexibility during the CIA term to identify risk areas and suggest modifications to the scope of the IRO reviews to evaluate evolving risk areas.
    • Have IRO review include a review of fair market value, payments made, procedures used to enter into the arrangement, and other elements that examine the terms of the arrangement.

Hope S. Foster, Practice Group Chair of Mintz Levin’s Health Care Enforcement Defense Group, commented, “The OIG's interest in hearing from companies now subject to CIAs is laudable.  I hope that the OIG carefully considers the input provided during this meeting and builds what it learned into the negotiations of future CIAs.”

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Pamela Kramer

Special Counsel

Pamela handles complex health care transactions and provides intricate regulatory and compliance counsel to health care clients across the United States.
Hope regularly defends health care companies in governmental investigations and ensuing cases, conducts internal investigations, and advises providers and manufacturers regarding enforcement issues.