OIG refuses to approve proposed arrangement between hospitals and network of clinical laboratories

The Office of Inspector General (OIG) of the Department of Health and Human Services issued an advisory opinion (AO 22-09) in which the agency declined to approve a proposed arrangement in which a network of clinical laboratories would compensate hospitals for certain sample collection services. for laboratory tests provided by them. A review of the facts helps to understand the reluctance of the OIG to sign this arrangement.

The clinical labs are offering to enter into contracts with various hospitals across the country where the hospitals would collect, process and handle samples which would then be sent to the clinical labs for testing services. The labs would bill third-party payers and federal health care programs for testing services. The labs would compensate hospitals on a per-click basis for testing services performed for people who are not currently inpatients or registered outpatients of those hospitals.

The advisory note notes that hospitals may employ or contract with physicians whose practices or medical groups may be owned by or under common ownership with those hospitals. Each hospital would be required to ensure that no employed or contracted physicians were referred to clinical laboratories; they would receive no remuneration from hospitals for any referrals.

The OIG observed that when individuals presented to a hospital for testing service without a laboratory specified on the order, the hospital was free to return that individual’s samples to the clinical laboratory with which they had contracted for the reimbursable tests. Because of the per-patient-encounter fee paid by clinical laboratories, these hospitals have a financial incentive to direct these samples to contracted laboratories. The OIG has stated that pay-per-click is not protected by the safe harbor for personal services and management contracts and results-based payment agreements. The OIG concluded that the patient-encounter compensation methodology could encourage hospitals to refer samples to contract laboratories, including for testing services that may be reimbursed, in whole or in part, by a federal compensation program. Health care.

Significantly, although hospitals state that their employed and contract physicians are not required to refer, or ordered to refer, to clinical laboratories, the OIG found that this safeguard was not sufficient to mitigate the risk of inappropriate orientation. Because hospitals have an incentive to encourage physicians to order laboratory services from contract laboratories, the OIG concluded that the arrangement “would present more than a minimal risk of fraud and abuse under the federal anti-bribery law”.

Two takeaways from this advisory are that the OIG remains wary of pay-per-click agreements that take into account the volume and value of potential referrals, and the OIG will always review agreements where the hospital can benefit from the references of its salaried or contractual doctors. The OIG will analyze all such arrangements from this perspective, including hospital-physician joint ventures where the hospital can benefit from referrals from its physicians, even those not participating in the joint venture.

Based on the relevant facts certified in your request for an advisory opinion and in your additional submissions, we conclude that the proposed arrangement, if undertaken, would generate remuneration prohibited under the federal anti-bribery law. wine, if the requisite intent was present, which would be grounds for the imposition of sanctions under the proposed arrangement under Sections 1128A(a)(7) and 1128(b)(7) of the Law.


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