OIG updates guidance on integrity agreements

The Health and Human Services’ (HHS) Office of Inspector General (OIG) last week updated its list of Frequently Asked Questions (FAQ) related to corporate integrity agreements (CIA) that are posted on its web site. But the update mainly tweaks the earlier iteration of the FAQs related to audit requirements for CIAs, and it now appears that the OIG’s efforts to quell the storm concerning these agreements have largely succeeded.

The health care industry has been very critical of what it viewed as the overly broad nature of CIAs, notes former OIG Counsel Howard Young. But since the release of HHS Inspector General Janet Rehnquist’s open letter on Nov. 20, 2001, which made changes in CIA audit provisions, Young says he has not heard very much in the way of criticism. Apart from the audit provisions, CIAs now are more narrowly tailored to the alleged misconduct, he adds. "Those were the two big areas where the OIG faced criticism," says Young, "and they have taken steps to address that."

That does not mean the issue of CIAs has gone away entirely. American Hospital Association (AHA) spokeswoman Alicia Mitchell says the issue still ranks high on the Chicago-based association’s list of issues. In fact, AHA may release its own guidance to hospitals in this area.

Former Justice Department attorney John Bentivoglio says the OIG certainly has eased some of burdens for small providers. But for major cases that involve allegations of widespread wrongdoing, CIAs still can be fairly onerous. He says a case in point is the pharmaceutical industry, where recent CIAs for Bayer and TAP Pharmaceuticals were extremely broad. "I don’t see any indication they are going to change that," says Bentivoglio.