Is Your Current Physician-Clinical Laboratory Arrangement Against the Law?

Posted by Donna Craig in Sep, 2014

On June 25, 2014, the U.S. Department of Health & Human Services issued a Special Fraud Alert citing the Office of Inspector General’s (“OIG”) concerns that certain laboratory practices with physicians may violate the federal Anti-Kickback Statute. OIG is particularly suspicious of certain arrangements in which a clinical laboratory contracts with a physician to collect, process and package patients’ specimens when the following characteristics are present:
• Payments made to a physician exceeds fair market value;
• Payments are made directly to the ordering physician and not the group practice;
• Payments are 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;
• Payments require the physician to order either a specified volume of test, type of test, or test panel; and
• Payment is made when a phlebotomist is placed in the office by the clinical laboratory or other entity that processes the specimens.

The OIG‘s Special Fraud Alert also addresses concerns about laboratories paying physicians to maintain patient databases or registries of patients who have undergone tests paid for by federal health care programs. Suspect arrangements include:
• Labs that require, encourage, or recommend physicians perform certain tests at certain frequencies in order to receive payment;
• Labs that collect comparative data for the registry, and bill for multiple tests that may be duplicative, not reasonable, or unnecessary;
• The compensation the lab pays a physician is based on the value or volume of referrals;
• Compensation to physicians exceeds fair market value;
• Labs offers payment arrangements to physicians only for tests it has patents on or that it exclusively performs;
• Labs collect data only from the tests it performs, rather than all laboratories;
• Lab requisition forms make it difficult for a physician to make an independent decision regarding medical necessity for each test ordered and for which the lab will bill; and
• Registry payments are made to physicians who meet selected criteria based on prior or anticipated referral volume rather than based on specialties or another basis.

Since violation of the federal Anti-Kickback Statute can result in civil and criminal sanctions, a review of your current or anticipated arrangements by The Health Law Center, PLC could be to your advantage. Contact us today to discuss your situation and learn how we can help!