HHS to promote self-disclosure in lieu of CIAs
HHS to promote self-disclosure in lieu of CIAs
By MATTHEW HAY
HHBR Washington Correspondent
WASHINGTON In what appears to be an effort to promote self-disclosure among healthcare providers and tame the growing number and complexity of corporate integrity agreements (CIA), the Department of Health and Human Services’ (HHS; Washington) Office of Inspector General (OIG) announced last week that the size and scope of CIAs will be scaled back in lieu of existing compliance programs in instances where the OIG deems it appropriate.
This shift in focus was revealed in a March 9 open letter from HHS Inspector General June Gibbs Brown and marks significant movement away from the increasing scope CIAs had started to assume. To date, more than 400 healthcare providers have entered into CIAs, and their expanding requirements had begun to raise the ire of providers.
Notably, the OIG reported that more than 70 healthcare professionals have now self-disclosed potentially abusive conduct. While still a modest number, that total does mark a notable uptake in the number of self-disclosures since Brown expanded the program two years ago, the OIG reported.
OIG Associate Inspector for Legal Affairs Lew Morris emphasized that providers must have an effective compliance plan in place and must self-disclose the potential problem.
"If the self-disclosing provider has demonstrated that its compliance program is effective and agrees to maintain its compliance program as part of the False Claims Act settlement, the OIG said it may not even require a CIA," said Brown. "In those cases, where in our judgment it is necessary to require the self-disclosing provider to enter into a CIA, the provider may need to make only limited changes to its existing policies and procedures to meet most of the requirements of the CIA."
Briefing reporters at the Health Care Compliance Association’s (Philadelphia) conference in Washington last week, Morris said the OIG wants effective CIAs that don’t "break the bank" and that appropriate compliance efforts on the part of suppliers should be credit "that turns into dollars."
Morris also defended the OIG’s current posture concerning self-disclosure in relation to whistle blowers. He said whistle blowers are free to come forward even when negotiations between providers and the government are under way, as long as there has been no public disclosure of the facts brought by the whistle blower.
"At present, there is no inconsistency," he argued. But he also noted a growing body of case law over what constitutes "original source material" brought by whistle blowers.
When False Claims Act liability results from such a disclosure, the OIG said, it will now be more flexible in considering the terms of a CIA in light of the demonstrated effectiveness of the provider’s compliance program.
"In general, we grant more deference to the existing compliance measures of a self-disclosing provider, even if those measures differ from what we might otherwise require in a CIA," stated Brown.
In cases where the provider’s own audits detected the disclosed problem, the OIG also reported, it might consider alternatives to the CIA’s auditing provisions and permit a self-disclosing provider to perform some or all of the billing audits through its internal auditors rather than require the retention of an independent review organization for each year of the CIA.
In addition, the OIG said, it may narrow the scope and focus of the claims review to the areas found out of compliance or allow alternate audit methodologies in lieu of the statistical sampling methodology that is generally required.
In addition to the audit provisions, the OIG said, many providers entering into CIAs express concern about the OIG’s exclusion authority when it determines the provider has materially breached the terms of the CIA. The OIG defended this practice, but said it will forego the exclusion remedy if the provider has made an appropriate self-disclosure and has demonstrated sufficient trustworthiness.
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