I had occasion to re-read the Department of Health and Human Services, Office of Inspector General (OIG) safe harbor amendments concerning electronic health (e-health) records, which became effective on March 27, 2014.
The new rule modifies the safe harbor, 42 C.F.R. § 1001.952, to the anti-kickback statute such that a party's behavior consistent with the safe harbor prevents enforcement. In particular, the rule clarified what types of activities associated with donations of e-health record software were innocuous commercial arrangements that should be safe from sanctions.
My focus in re-reading the rules was on the limits placed on laboratory companies to donate e-health record items and services. In fact, the rule removes laboratory companies from the scope of protected donors under the safe harbor provisions, in order to reduce the likelihood of misuse by donors to secure referrals.
It is too soon to tell what impact this new rule will have on laboratory companies.
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