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Compliance Program Reviews and Compliance Experts

HHS OIG has recently demonstrated a new trend in Corporate Integrity Agreements (CIAs) it settles with organizations. The OIG is requiring Boards to engage Independent Compliance Experts to assist in meeting CIA obligations of Compliance Program oversight. In these CIAs, the Board must retain an individual or entity as a Compliance Expert to perform a Compliance Program Review to evaluate Program effectiveness. These Compliance Program Reviews must take place for each reporting period of the CIA. Many CIAs now contain this requirement, including Parkland, DaVita, Millennium, Respironics, Health Diagnostics Laboratory, and Singulex. Compliance Experts must have a demonstrated expertise in Federal health care programs in order to take the role as an Expert. Once engaged, the Compliance Expert is expected to create a work plan to conduct a Compliance Program Review, execute the work plan, and provide a Compliance Program Review Report (Review Report) that both describes the review conducted and any recommendations arising from it. Boards are mandated to examine the Review Report as part of their CIA obligations and provide a copy of the Review Report to the OIG as part of each Annual Report filing. The Compliance Expert, upon OIG request, must send the OIG copies of any materials that the Compliance Expert provides the Board as well as minutes of meetings between the Compliance Expert and the Board.

The OIG’s position on Experts is clear. It is the entity’s responsibility to select their Independent Review Organization (IRO) and their Compliance Expert, not the OIG’s responsibility, as the OIG may not endorse an IRO or Compliance Expert. The OIG does, however, reserve the right to question and review an IRO or Compliance Expert’s work. The OIG also has the right to deny the use of an IRO or Compliance Expert if they are found to be inadequate or conflicted. Under the CIA, the OIG has access to IRO and Compliance Expert work papers and correspondence. If the OIG determines that work of the IRO or Compliance Expert is inadequate, the OIG may conduct its own review.

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Independent Compliance Expert Tips

  1. Seek recommendations from others.
  2. Choose firms with CIA review experience (increased efficiency, lower costs).
  3. Don’t select anyone who will be learning what to do as “on the job training.”
  4. Choose firms with operational review experience rather than financial review experience.
  5. Remember that Experts are not advocates and must be independent.
  6. Keep in mind that knowledge and experience increases efficiency and also lowers costs.
  7. Request the identity and credentials of the individuals who will perform the work.
  8. Recognize that knowledge of statistical sampling may be critical for certain reviews.
  9. Look for independent Experts through different sources; Experts can be a consulting, audit, or law firm.
  10. Identify whether the CIA requires several different types of reviews.
  11. Confirm that the Expert is qualified in the specific areas covered by the CIA.
  12. Identify whether the Expert lacks expertise in area the Expert is engaged for. A lack of expertise can result in problems with OIG.
  13. A sub-standard report risks loss of a compliance program’s credibility.
  14. The Expert must be professionally independent and objective.
  15. The Expert must follow the Government Accountability Office’s guidance on Generally Accepted Auditing Standards (GAGAS) for operational reviews.
  16. Ensure that the Experts certifies to OIG professional standards.
  17. Confirm that the Expert does not have a conflict of interest or other business relationship with the entity.
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