After the OIG found the similarities between the proposed agreement and the agreements previously considered “dodgy joint enterprise agreements” (see z.B. Advisory Opinion 04-17), the OIG concluded that the proposed agreement did not meet the requirements of one of the existing safe ports. The OIG also cited the reasons why the proposed anti-kickback status scheme was more than a minimal risk. First, the applicant`s pricing structure and reliance on investors interested in generating transactions through their transfers to Path Lab “would represent the risk of overcharging laboratory services, distorted medical decision-making and increased cost to federal health programs.” Moreover, the proposed regulations “appeared to have no commercial purpose other than to allow medical investors to profit from commercial activity… The fact that they would indirectly benefit from it was not insignificant. Given the current economic situation, laboratories have had to make significant changes to their equipment procurement practices. Lab managers are more likely to operate as businesses and therefore have greater financial and purchasing responsibility. Controlling costs and buying smartly have become common practice in most laboratories across the country. In a typical situation, the laboratory manager enters into a service agreement with the first OEM when purchasing new laboratory equipment. It is a common practice and it has been done this way for years.
Other laboratories, such as clinical research/hospital, university/university or state aid, may require offers from multiple suppliers for equipment purchases, and a service contract is often included as part of the invitation. In both cases, a detailed procurement process is required to ensure that laboratory equipment requirements are met. In an expertise that many in the laboratory industry had long been waiting for, the OIG concluded that a regulatory proposal that would have allowed physicians to benefit from their own transfers of anatomical pathology services “would present more than a minimal risk of fraud and abuse.” The American Clinical Laboratory Association and other industry organizations have been opposed to such trade agreements for many years.