The Health and Human Services Office of Inspector General (HHS-OIG) recently issued a favorable advisory opinion (AO-26-02) stating that it would not sanction an urgent-care management company for operating a separate clinical lab that would primarily test specimens from the urgent care centers it manages, as described to OIG. On the facts presented, OIG said it would not impose administrative sanctions under the federal Anti-Kickback Statute.
According to the Requestor, the lab would bill payors directly (including federal programs), would not be on the urgent care premises, and would not be owned or operated by anyone positioned to refer testing to it. Patients would get written notice of the relationship and a choice of labs; the EHR would allow orders to multiple labs without preference; the company said it would not require or track referrals to the lab; and no provider/supplier compensation would be tied to lab volume or value. The Requestor represented that neither party “would offer or pay any remuneration to any individual or entity in connection with the referral of specimens to the Laboratory.”
Based on those representations, OIG determined that “the Federal anti-kickback statute would not be implicated because neither Requestor nor the Laboratory would pay any remuneration to any individual or entity to induce the referral of specimens to the Laboratory for testing.”
OIG also warned that its conclusion is fact-specific and could change if the facts change (for example, if compensation were paid to referral sources to induce or reward the referral of laboratory specimens to a particular laboratory for testing that is reimbursable by a federal health care program). That kind of arrangement would implicate the federal anti-kickback statute.
For more information about this advisory opinion or other health care regulatory matters (including Anti-Kickback Statute, Stark Law, and billing/compliance questions), please contact a member of Butler Snow’s Health Law Group.
