The United States Court of Appeals has decided that the Renal Physicians Association (RPA), a national professional association, does not have legal standing to challenge the legality of the Stark Regulations.

RPA had asserted that certain of the Stark regulations defining fair market value and personal service arrangements for purposes of establishing exceptions to the statutory  prohibition of referrals to financially related entities were not properly promulgated, and that the regulations were harming its members who had medical director agreements with dialysis facilities. The United States District Court, the trial court below in this matter, had granted the motion of the United States Department of Health and Human Services (HHS) seeking dismissal of the Complaint for lack of standing, i.e., the assertion that RPA by itself had not suffered any direct harm, regardless of any harm to its members, and, therefore, had no legal “standing” to bring this litigation. In upholding the decision of the District Court, the Court of Appeals wrote that standing on behalf of RPA would require that the regulations could be shown to be illegal or that the action requested by RPA had the potential of redressing the harm asserted. The Court concluded that neither element was present, concluding that redress was not available because, even if the action requested by RPA was granted, i.e., the retraction of the regulations, members of RPA would still be confronted with the statutory language of the Stark Act declaring that referrals were prohibited unless one of the statutory acceptance was available.

The case is Renal Physicians Association vs. U.S. Department of Health and Human Services, and it was decided by the United States Court of Appeals for the District of Columbia on June 12, 2007 (No. 06-5133).