Problem
Review the following two CMS Advisory Opinions: CMS AO-2010-01 and CMS AO-2013-01. Both of these opinions involved clinical laboratories that provided free devices to referring physicians. In the 2010 opinion, CMS found that the provision of the device would constitute a "compensation arrangement" between the laboratory and the physician, but in the 2013 opinion it found that the provision of the device would not constitute a "compensation arrangement." Why did the two opinions come out differently? Do you think the different results are justifiable as a policy matter? If so, what is the policy rationale underlying the distinction? If not, should the law be changed so that both situations would be considered "compensation arrangements" or so that neither situation would be considered a compensation arrangement?