Pay-to-play is a cornerstone of many extremely efficient and perfectly legal markets. In healthcare it raises a host of ethical, legal and clinical questions – not the least of which is whether the patient benefits or is harmed from the transaction. Paying for referrals, always considered unethical, has been illegal since 1972. The Office of the Inspector General (OIG) in the Department of Health and Human Services (HHS) has issued a series of opinions concerning referrals supported by an HIE. Taken together, these opinions suggest that HIE organizations need to be aware of the possibility of liability under the Anti-Kickback Statute.
In 2011, EHR vendor athenahealth asked for an advisory opinion about a referral application it planned to offer its customers. The OIG blessed athenahealth’s general approach. A national reference lab then sought an opinion from OIG about how it could interoperate with athenahealth’s referral application. This time, the OIG found problems with the lab’s requested participation and went further, reversing its qualified blessing of athenahealth’s referral application.
The conclusion was that the HIE operator, in this case athenahealth, and the laboratory could be subject to sanctions or expensive entanglements with federal authorities based on the fee structure of their relationship and offerings. These OIG opinions are interesting for two reasons. They illustrate how someone else’s business practices can give rise to potential violations of the Anti Kickback Statute. They also show that the simplest and most common referral — a physician sending a specimen to a reference lab — can be more complex than it appears.