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Michaud Mittelmark & Antonacci, P.A. - The Healthcare Law Firm

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Legal Alert: OIG Advisory Opinion No. 04-17

 

DATE:      DECEMBER 17, 2004

TO:          CLIENTS & FRIENDS

FROM:      MARK A. COEL, ESQ.,  TRANSACTIONAL AND REGULATORY DIVISION

RE:           OIG RELEASES ADVISORY OPINION NO. 04-17

In Advisory Opinion No. 04-17, just issued on December 17, 2004, the OIG determined that a proposed  arrangement between a pathology services company (Company) and various physician group practices could potentially violate the Federal Anti-Kickback Statute.  Under a variety of service contracts and leases with each group practice, the Company proposed to furnish all management and all pathology services, equipment and space necessary for the operation of each groups' off-site pathology laboratories, an arrangement similar to some "block lease" transactions.  The groups would bill patients or insurers directly for such services, for which the Company would receive a flat monthly fee, a per-specimen fee and, if applicable, a billing fee.  

The OIG determined that, even if the various service contracts and leases making up the proposed arrangement complied with the safe harbor conditions applicable to such agreements, the safe harbors would only protect the remuneration paid thereunder by the physician groups to the Company for actual services rendered or equipment and space rented.  The OIG determined that the profit retained by the physician groups in the form of the difference betweenthe reimbursement received by them from Medicare and the fees paid to the Company for its services might be considered impermissible remuneration if the requisite "kickback" intent under the statute could be established. 

While facts peculiar to the proposed arrangement may have driven the result in this Opinion, it raises serious concerns regarding the OIG's willingness to disregard safe harbor compliant service contracts and leases whenever a referral source may be in a position to make more than it is paying for the provision of the technical component of Medicare-covered services.


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