National Health IT Week was a busy time with regard to government announcements. First, the final rule for Meaningful Use Stage 3 and Modifications was released and second, on the same day, the Office of the Inspector General (the “OIG”) released a reminder about information blocking concerns. The issue of information blocking has been coming up more frequently this year. It has been the subject of congressional inquiries, Office of the National Coordinator of Health IT (“ONC”) reports, and more. To some degree then, it almost seems natural that the OIG, an enforcement wing within the Department of Health and Human Services, would join the party.
The OIG is concerned the information blocking could be a way of forcing referrals or otherwise generating business. For the basis of its concern, the OIG reminds the healthcare industry that there is a safe harbor to the Anti-Kickback Statute that addresses provision of an electronic health record (“EHR”) by one company to another. The safe harbor exempts provision of an EHR from one healthcare entity to another, if the following elements are met:
- The EHR is provided to someone engaged in the delivery of healthcare by another individual or entity (other than a lab) that bills a federal healthcare program, or a health plan;
- The EHR is “interoperable” when it is provided (for purposes of the safe harbor, interoperable means it has been certified by the ONC);
- The entity or individual providing the EHR does not take any action to limit or restrict the use, compatibility, or interoperability of the software with other systems;
- The provision of the EHR is not conditioned on conducting other business;
- The provision of the EHR in no manner takes into account the volume or value of referrals between the donor entity and the recipient entity;
- The donation is set forth in a written agreement;
- The entity or individual providing the EHR does not have actual knowledge or should have knowledge that the receiving entity or individual received similar items from another;
- If the EHR can be used with any patient, there is no restriction on use of the EHR with any patient; and
- Staffing is not included, nor is the EHR used primarily for personal use.
The elements of the EHR safe harbor have been around for a number of years at this point. It is from the basis that the OIG sent out is reminder. As the OIG states in the reminder, interoperability is a prerequisite for satisfying the safe harbor. If an EHR cannot work with others, then it is a warning sign of an issue. The reminder implies that a key and essential purpose of permitting the provision of an EHR is to enable the free flow of medical information.
Where does the reminder leave the industry though? It is clear from many discussions that interoperability is high on the mind of many in the industry. However, there is not a clear consensus as to what interoperability even means. The definition in the EHR safe harbor for the Anti-Kickback Statute likely does not bear any resemblance to popular discussions of interoperability. Merely receiving certification from ONC does not often come up as a hallmark of interoperability.
The more interesting statements from the OIG’s reminder are the examples of what the OIG is concerned about. The examples include provision of an EHR that precludes or inhibits a competitor from interfacing with the system, and a second is one where the EHR vendor agrees with the entity or individual providing the EHR to charge a high-interface fee. Both examples seem to go beyond the bare definition of interoperability contained in the safe harbor.
Interestingly, the second example veers in the direction of a concern raised by Paul Levy in a post on his blog Not Running a Hospital. Mr. Levy wrote about the new relationship between Epic and Partners Healthcare. Mr. Levy did not allege potential Anti-Kickback Statute concerns, instead questioning whether the new Epic and Partners Healthcare relationship violated antitrust requirements. However, the post focused on the requirement that all in the Partners Healthcare network adopt Epic, with a fair amount of attention spent on the difficulty of getting Epic to interact with other EHRs. Is the OIG reminder a harbinger of actions against Epic?
Time will tell whether any EHR donations will be pursued for violating the Anti-Kickback Statute or EHR vendors will be hassled for locking down systems. The primary issue is that so many branches and divisions of the government are discussing interoperability issues and are trying to address it. ONC is trying to solve from the technology side and ensure that interoperability truly exists; the OIG wants to ensure that blocking interoperability is not a means of locking in a referral source or otherwise rewarding a referral source; other branches are also considering interoperability and what it means.
The one thing missing from all of these efforts though is a common understanding of what interoperability really is. The health IT community has one view, the OIG clearly has a different one, patients likely have a third, and each new group will add its own. A common understanding or goal will be very helpful in advancing the debate and getting to a goal that could actually be realized.
One thing is for sure though, healthcare organizations should evaluate relationships where an EHR is provided under the ambit of the Anti-Kickback Statute EHR safe harbor. The OIG has puts its stake in the ground. It is a fair bet that at some point an example will be made or a whistleblower will take the reminder and run with it. Remember, the OIG has provided its warning, do not ignore it.