Amid bipartisan concerns in Congress and multiple U.S. Department of Health and Human Services (HHS) agencies about health "information blocking," the HHS Office of Inspector General (OIG) recently issued an alert reminding the health care industry that health information blocking can impact whether an arrangement satisfies the electronic health record (EHR) items and services safe harbor (42 C.F.R. § 1001.952) (EHR Safe Harbor) under the federal Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b(b)).
The EHR Safe Harbor permits certain health care providers and other donors to pay up to 85 percent of the cost of EHR technology provided to a physician practice or other referral source if the arrangement meets all EHR Safe Harbor elements. The third element of the EHR Safe Harbor requires that "The donor (or any person on the donor's behalf) does not take any action to limit or restrict the use, compatibility, or interoperability of the items or services with other electronic prescribing or electronic health records systems (including, but not limited to, health information technology applications, products, or services)."
In the alert, the OIG cautions that information blocking may cause an arrangement that would otherwise satisfy the EHR Safe Harbor to fail to meet the third element. In an April 2015 report cited by the OIG in the alert, the Office of the National Coordinator of Health Information Technology defines information blocking: "Information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information."
Previously, the OIG expressed concern about this issue in the preamble to its final rule amending the EHR Safe Harbor in 2013, stating, "[D]onors must offer interoperable products and must not impede the interoperability of any electronic health record software they decide to offer . . . Agreements between a donor and a vendor that preclude or limit the ability of competitors to interface with the donated software would cause the donation to fail to meet the condition at 42 CFR 1001.952(y)(3), and thus preclude protection under the electronic health records safe harbor." (78 Fed. Reg. 79202, 79209 [December 27, 2013]).
The alert cites several examples of information blocking that would threaten protection under the EHR Safe Harbor. For example, if a provider limits the use or interoperability of software by agreeing with the potential referral source to prevent a competitor from interfacing with the software, the safe harbor requirements would not be satisfied. Likewise, if the software vendor agrees with a provider to charge high interface fees to outside providers or suppliers or to competitors, the safe harbor requirements may not be satisfied.
In order to avoid running afoul of the AKS (and resulting False Claims Act [FCA] claims), health care providers considering the roll-out of below-cost EHR technology to physician practices or other referral sources should take care to avoid health information access restrictions that unreasonably interfere with access to information for continuity of care or other appropriate purposes and, thereby, threaten EHR Safe Harbor protection.
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