Hanlester Laboratories decision: how is it affected by new sanctions and penalties regulations?

The following excerpts from the briefs recently submitted to Administrative Law Judge (ALJ) Stephen Kessel in the Hanlester Laboratories administrative proceeding, deal with the applicability of a January 29, 1992 final rule on fraud and abuse sanctions and civil money penalties (57 Fed. Reg. 3,298 (January 29, 1992) to the case. Counsel for Hanlester Laboratories, Patric Hooper and W. Bradley Tully of Hooper, Lundy & Bookman, Inc. in Los Angeles, argue that the Office of the Inspector General (OIG-HHS) is trying to change the rules "well after the game has been played," and that this "is obviously being done for the sole purpose of negating the rights" of the Hanlester respondents. The Office of the General Counsel (OGC), in a brief prepared by OGC attorney Larry J. Goldberg, contends that ALJ Kessel "must apply these regulations in rendering his decision," arguing that the "regulations at issue do not even involve a change in policy, but merely a clarification." The Hanlester case (The Inspector General v. Hanlester Network et al., No. C-448 (Department of Health and Human Services, Departmental Appeals Board, Civil Remedies Division) was remanded by the Departmental Appeals Board to ALJ Kessel on September 18, 1991. It is the first case to consider the application of the antikickback statute to a joint venture, and is the first HHS civil exclusion case to be brought as the result of allegations of violations of the antikickback statute (see HealthSpan, November 1991, p. 8).