corporate integrity agreements

The OIG has updated its guidance for providers under Corporate Integrity Agreements regarding the circumstances that might affect the independence and objectivity of independent review organizations (IROs). The updated guidance reflects 2011 revisions to Government Accountability Office (GAO) auditing standards (known as the “Yellow Book”).

On April 20, 2015, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) released educational guidance designed to assist governing boards of health care organizations (“Boards”) in their compliance oversight functions. This guidance, entitled “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”), was developed in a collaborative effort among the OIG, the Association of Healthcare Internal Auditors (“AHIA”), the American Health Lawyers Association (“AHLA”), and the Health Care Compliance Association (“HCCA”). The Guidance updates previous guidance issued by OIG and AHLA, and incorporates insight from the AHIA and HCCA to help assist the internal auditors, compliance officers, and lawyers that report to the Boards. The document addresses four key issues relating to a Board’s oversight and review of compliance program functions: (1) the roles and relationships among an organization’s audit, compliance, and legal departments; (2) the mechanisms and processes for reporting to the Board; (3) identifying and auditing regulatory risk; and (4) methods to encourage organization-wide accountability for achieving compliance goals and objectives.
Continue Reading OIG Partners with Industry Associations by Issuing Practical Guidance for Health Care Governing Boards on Compliance Oversight

The OIG published a notice July 11, 2014 announcing that it is considering revising its nonbinding criteria, established in 1997, outlining the circumstances under which the OIG may exercise its permissive authority under Section 1128(b)(7) of the Social Security Act to exclude an individual or entity from participation in the federal health care programs for

The OIG held an August 7, 2012 OIG “roundtable” meeting with representatives of companies that have entered into corporate integrity agreements (CIA) since 2009 to solicit feedback on compliance “best practices” and companies’ efforts to implement CIA requirements. The 32 companies represented included hospitals, ambulance companies, medical device manufacturers, physician practices, laboratories, home health

The OIG has released a report from its February 23, 2012, government-industry “Pharmaceutical Compliance Roundtable.” The Roundtable was convened to allow OIG representatives to discuss with pharmaceutical industry compliance professionals their experiences under corporate integrity agreements (CIAs) and with various types of compliance activities. Specific topics of discussion included: challenges in implementing CIAs; compliance

We want to alert our manufacturer clients to the potential importance of a specific provision included in our analysis of the recent health care reform legislation. As we note at page 108 of our memorandum:

Medicaid Exclusion from Participation Relating to Certain Ownership, Control, and Management Affiliations (Sec. 6502)

[T]his provision requires Medicaid agencies to exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that: (1) has failed to repay overpayments during the period as determined by the Secretary; (2) is suspended, excluded, or terminated from participation in any Medicaid program; or (3) is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.
Continue Reading Caution Lights Ahead for Pharmaceutical Settlements? Impact of Medicaid Exclusion Provisions of PPACA

On October 15, 2009, the OIG published a notice that seeks information from organizations that believe they have the capability to be monitors of health care entities under quality-of-care CIA with OIG.  Such monitors typically are responsible for assessing the effectiveness, reliability, and thoroughness of the health care entity’s: (1) internal quality control systems