OIG Says Waiver of Laboratory Fees Could Violate Anti-Kickback Statute

In OIG Advisory Opinion 15-04, the requestor, a multi-regional medical laboratory proposed to enter into agreements with physician practices which would allow the requestor to provide all laboratory services for the physician’s patients. The requestor indicated that physicians desired such a relationship because it would provide for better communication and consistency (e.g. consistent reference ranges and interfaces). The current barrier to such a relationship is the requirement by certain “Exclusive Plans” that labwork be sent only to certain designated laboratories (not including the requestor).

In the requestor’s proposed arrangement, laboratory services provided to patients covered by an Exclusive Plan would be provided free of charge – with no charges going to the patient, the physician or the Exclusive Plan.

The OIG determined that the proposed arrangement could violate the anti-kickback statute, which makes it a crime to knowingly and willfully offer, pay, solicit or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program (e.g., Medicare or Medicaid). Although the requestor certified that it was not providing any financial benefit to the physicians, the OIG noted that the physician practices would be provided with the benefit of the convenience and efficiencies related to consistent reference ranges, as well as the convenience and efficiency of a single user interface. The OIG further noted that physicians may be able to avoid certain maintenance costs associated with multiple user interfaces if they were able to use a singled interface as proposed by the requestor. The OIG determined that these factors in combination could be viewed as “remuneration” pursuant to the anti-kickback statute.

The OIG also stated that the arrangement might violate Section 1128(b)(6)(A) of the Social Security Act which can result in exclusion of providers who charge Medicare and Medicaid programs “substantially in excess” of usual charges. The OIG noted that the proposed arrangement could result in the requestor providing more than half of its services for no charge.

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