The Department of Health and Human Services Office of Inspector
General ("OIG") recently issued a Special Fraud Alert regarding certain types of
remuneration from laboratories to physicians who refer business to
them. For laboratories that perform services that are reimbursable
under Medicare, Medicaid, or any other federal healthcare program,
the arrangements described will potentially violate the federal
Anti-Kickback Statute (AKS).
Under the AKS, it is a crime to knowingly and willfully offer, pay,
solicit or receive any remuneration to induce, or in return for,
referrals of items and services reimbursable under a federal
program. Violators may also be excluded from participation in the
Medicare and Medicaid programs. The term "remuneration"
includes the payment of anything of value, and often includes
arrangements that would be considered logical and acceptable in
non-healthcare contexts. The "offer, pay, solicit or
receive" language means that a physician who receives a
payment from a lab is equally at risk as the lab under the
AKS.
The main part of the alert deals with "Specimen Processing
Arrangements," in which labs pay physicians to collect,
process, and package patients' blood specimens. The OIG notes,
however, that its AKS analysis would also apply to other similar
arrangements, including for the collection and processing of urine
samples. Whether the AKS is violated depends on the intent of the
parties, even if the payment to the physician is based on the fair
market value of the services rendered. In practice, however,
arrangements in which payments exceed the fair market rate for the
services rendered, or where the services are normally reimbursed in
some other manner, are at far greater risk of a claimed AKS
violation.
The OIG also points out that payment arrangements that are
calculated on a per-specimen basis inappropriately take into
account the "volume or value of referrals," one of the
key criteria of the AKS prohibition. Some unlawful Specimen
Processing Arrangements even reimburse physicians for collection
services that are actually performed by a phlebotomist placed in
the physician's office by the lab.
The Alert stresses that arrangements that "carve out" (do
not provide remuneration directly for) federal program business can
still potentially violate the AKS. The OIG believes that because
physicians typically prefer to use the same labs for their federal
and non-federal program patients, payment arrangements that are
based on referrals of non-federal business may be intended to
induce the referral of federal program business as well.
The Alert also covers "Registry Arrangements" in which
laboratories make payments to physicians to collect data on their
patients, which the OIG says may also be intended to induce
referrals of business from the physicians.
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