The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an alert on October 6, 2015, affirming that information blocking practices violate federal Anti-Kickback Statute (AKS) Safe Harbors and Stark Law Exceptions for donation of electronic health records and related software. Hospitals, among others, routinely rely on the AKS Electronic Health Record (EHR) safe harbor for protection when donating "interoperable EHR software or information technology and training services" to physicians and other providers who are in a position to refer patients to the donor hospital. The corresponding Stark exception, while used less frequently, is also implicated by this alert. OIG specifically points out that it closely coordinates with CMS on issues related to EHR donation.
The AKS EHR safe harbor specifically prohibits anyone donating EHR, or related software, from taking "any action to limit or restrict the use, compatibility, or interoperability of the [donated] items or services with other [EHR] systems." OIG has noted previously that actions taken by donors of EHRs and related software, either directly or indirectly through vendors, which limit or restrict the interoperability of the EHR, violate this component of the AKS safe harbor. In order to qualify under an AKS safe harbor, or a Stark exception, one must meet all of the requirements and failure to meet any of them negates the safe harbor or exception. The OIG alert affirms its previous guidance that not only is safe harbor protection not available, but any EHR donations made outside the safe harbor are suspect under AKS and violate Stark.
The alert, labeled as a "policy reminder," cites the 2015 report from the HHS Office of the National Coordinator for Health Information Technology (ONC) to Congress on information blocking practices. The ONC report was very critical of widespread practices that result in information blocking in the health care sector. The OIG alert makes clear that hospitals and others that rely on the AKS EHR safe harbor, or the Stark exception, are at risk if they adopt contractual terms or business practices that result in information blocking.
The OIG alert offers the following two examples of prohibited restrictions:
- contractual terms that limit the ability of the EHR donee to share information with anyone other than the donor; and,
- arrangements between EHR donors and technology vendors whereby the vendor would charge higher fees for interfaces between the donee's EHR and the EHR of one of the donor's competitors.
It is important to note that these are only examples and there are other more subtle ways in which donors may restrict the interoperability of a donated EHR. Hospitals, or others that have donated EHR technology to referral sources, should reexamine their agreements and business model in light of this OIG alert.
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