OIG-CMS Release Final Rules that Address EHR Donations by Labs 

The Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have published final rules that exclude laboratories from the list of protected electronic health records donors under the Stark Law and the safe harbor exception to the Anti-Kickback Statute, effective January 1, 2014. The rules appear in the December 27, 2013, Federal Register.

The OIG's rule, which contains wording similar to the CMS rule, says, "...based on the concerns articulated by commenters and the wide-ranging support from the entire spectrum of the laboratory industry (from small, pathologist-owned laboratory companies to a national laboratory trade association that represents the industry's largest laboratory companies), we are finalizing our proposal to remove laboratory companies from the scope of protected donors under the safe harbor..."

Click to view the OIG rule (see page 79208) and the CMS rule (see page 78757).