Those health care providers and suppliers who are contemplating accepting donations of electronic health records software and training services should be aware of proposed amendments to the regulations that might protect such arrangements under the anti-kickback statute and the Stark physician self-referral law. The Department of Health and Human Services, Office of Inspector General (“OIG”) is proposing to amend the anti-kickback safe harbor pertaining to electronic health records (“EHR”) items and services found at 42 CFR 1001.952(y).  The Centers for Medicare and Medicaid Services (“CMS”) is proposing the same amendments to the Stark physician self-referral exception pertaining to donations of certain EHR software and directly related training services found at 42 CFR 411.357(w).  The OIG safe harbor and physician self-referral exception were promulgated in 2006 to protect certain arrangements involving the donation by permitted donors of interoperable electronic health records software or information technology and training services.  Both proposed rules make the identical changes to the protections offered under the safe harbor and exception.

First, the proposed amendments would update the provision under which EHR software is deemed interoperable. Interoperable has been defined to mean “able to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks, in various settings, and exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.” Both CMS and the OIG consider interoperability to be an important concept to reduce the risk that parties might use the donated software and technology to capture referrals. Both considered that, if the donated technology is interoperable, the recipient would be able to use the technology to transmit EHR not only to the donor but to others, including competitors of the donor, and would not be “locked-in” to communications with the donor only.