On June 25th, the Department of Health and Human Services Office of Inspector General (OIG) released a warning to clinical laboratories and physicians that providing compensation to physicians for collecting, processing and packaging of patient specimens and/or establishing a database to collect patient testing data could violate federal anti-kickback law. The OIG stated in its alert that it “reiterates our long standing concerns about payments from laboratories to physicians in excess of the fair market value of physicians’ services and payments that reflect the volume or value of referrals of Federal health care program business.” The alert stated that these arrangements may violate anti-kickback law in multiple instances, such as:
• Payment made directly to the ordering physician, rather than to the ordering physician’s group practice, which may bear the cost of collecting and processing the specimen
• Payment made on a per specimen basis for more than one specimen collected during a single patient encounter or on a per test, per patient, or other basis that takes into account the volume or value of referrals
• Payment made to the physician or physician’s group practice, despite the fact the specimen processing is actually being performed by a phlebotomist placed in the physician’s office by the laboratory or a third party
The OIG went on to say in this release, “Arrangements that ‘carve out’ Federal health care program beneficiaries or business from otherwise questionable arrangements implicate the anti-kickback statute and may violate it by disguising remuneration for Federal health care program business through payment of amounts purportedly related to non-Federal health care program business.” The OIG has also acknowledged it is aware of arrangements where clinical laboratories are “establishing, coordinating, or maintaining databases, either directly or through an agent, purportedly to collect data on demographics, presentation, diagnosis, treatment, outcomes, or other attributes of patients who have undergone, or who may undergo, certain tests performed by offering laboratories.” The alert went on to say, “Typically these are specialized and expensive tests paid for by Federal health care programs.”
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