On October 6, 2015, the HHS Office of Inspector General (OIG) issued guidance addressing its policy on the offer of electronic health record (EHR) technology that is purposefully limited in interoperability among providers. OIG’s guidance, entitled “OIG Policy Reminder: Information Blocking and the Federal Anti-Kickback Statute” is intended to reiterate that evidence of “information blocking” may show a provider’s intent to violate the federal anti-kickback statute (AKS). OIG recognizes that information blocking occurs when “persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information.”
In publishing this guidance, OIG cited the Office of the National Coordinator for Health Information Technology (ONC) April 2015 Report on Health Information Blocking, in which ONC called on federal agencies to coordinate efforts to target and address EHR information blocking in the context of AKS and the Stark Law.
OIG noted that parties exchanging EHR technology may avoid AKS liability by complying with the requirements of the EHR safe harbor codified at 42 CFR § 1001.952(y). However, an arrangement in which a provider seeks to furnish EHR to a referral source where the offeror seeks to limit the interoperability of EHR with other provider systems would not be entitled to safe harbor protection. OIG noted that the EHR safe harbor requires that “[t]he 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 [EHR] systems (including, but not limited to, health information technology applications, products, or services).”
OIG’s guidance provides two examples of actions that would not comply with the EHR safe harbor:
- Donors taking action “to limit the use, communication, or interoperability of donated items or services by entering into an agreement with a recipient to preclude or inhibit any competitor from interfacing with the donated [EHR] system.”
- EHR technology vendors agreeing with donors “to charge high interface fees to non-recipient providers or suppliers or to competitors.”
- OIG asserted that “any action . . . 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.” OIG warned that evidence of action taken to restrict EHR interoperability, including as set forth in the examples above, may provide evidence of a provider’s intent to induce referrals in violation of AKS requirements.