Bass, Berry & Sims attorney Jennifer Michael examined the January 11 final rule issued the by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) that removes one of the most commonly used bases for rejecting advisory opinion requests. Jennifer’s analysis is available in the Health Law Weekly series published by the American Health Law Association (AHLA).
As Jennifer outlined, OIG cited two reasons for removing the provision. “First, OIG claimed that its removal will provide the agency with ‘more flexibility’ to issue favorable or unfavorable opinions when requests involve conduct that is the same or substantially the same as conduct that is under investigation. Second, OIG stated that the change ‘may provide industry stakeholders with greater transparency’ regarding the factors OIG considers when evaluating compliance with the federal fraud and abuse laws.”
However, as Jennifer points out, this transparency comes at a cost, as OIG is no longer required – or permitted – to reject opinion requests under this basis. “Consequently, requestors may be many months into the advisory opinion process before OIG informs them that an advisory opinion is likely to be unfavorable.”
The full article, “What OIG’s Removal of a Frequently Cited Basis for Rejecting Advisory Opinion Requests Means for the Government and for Requestors,” was published as part of the AHLA Health Law Weekly series on January 28 and is available online (subscription required).
For additional insight on the new final rule, read analysis by Bass, Berry & Sims attorneys Jennifer and Stewart Kameen here.