The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health information — may affect protection under the regulatory electronic health records (EHR) safe harbor to the federal anti-kickback statute (AKS).
By way of background, the EHR safe harbor (42 C.F.R. § 1001.952(y)) provides that, for purposes of the AKS, “‘remuneration’ does not include nonmonetary remuneration (consisting of items and services in the form of software or information technology and training services) necessary and used predominantly to create, maintain, transmit, or receive electronic health records,” if all of the conditions of the EHR Safe Harbor are satisfied. One of the conditions for use of this safe harbor is 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 Policy Reminder, the OIG notes its belief that donations that have limited or restricted interoperability due to action taken by the donor or on the donor’s behalf “would be suspect under the law as they would appear to be motivated, at least in part, by a purpose of securing Federal health care program business” (78 Fed. Reg. 79,202, 79,213 (Dec. 27, 2013).
OIG restated its view that “any action taken by a donor (or any person on behalf of the donor, including the [EHR] vendor or the recipient) to limit the use of the donated items or services by charging fees to deter non-recipient providers and suppliers and the donor’s competitors from interfacing with the donated items or services would pose legitimate concerns that parties were improperly locking-in data and referrals and that the arrangement in question would not qualify for safe harbor protection.” Id. The OIG also discussed its concerns regarding data lock-in, and therefore, referral lock-in in OIG Advisory Opinion 12-19.
The OIG reaffirmed its commitment to “investigating potentially abusive arrangements that purport to, but do not actually, meet the conditions of the EHR safe harbor.” The OIG encourages the public to report instances when a donor or the donor’s agent limits the interoperability of donated items or services, since such action “could provide evidence of the intent to violate the Federal anti-kickback statute.”