What About the Complete EHR-Versus-Modular-Technology Conundrum?

One attorney who consults heavily on MU shares his insights on an important question

As Healthcare Informatics has reported extensively on its website, one issue whose profile rose considerably during the HIMSS011 Conference in Orlando in late February was the question of what hospital organizations can and should do if they want to use niche vendor products along with their core electronic health record (EHR) solutions, and still become certified for meaningful use under the HITECH Act’s provisions. The Office of the National Coordinator for Health Information Technology (ONC) recently posted a version of that question (Question 9-10-014-1), and an answer to it, on its website, under its FAQ (frequently asked question) section.

Of course, even after reading the question and the answer, as articulated in that section, one might still have questions. We certainly did. What appears to be true is that a provider organization can run, say for example, a niche vendor’s ED information system, as long as that organization essentially purchases the rights to use both that system and the EDIS of the complete EHR system from its core EHR vendor.

There is still ambiguity here, though, as one will discover when one reads the full question and answer, particularly in the phrase “so long as all of the applicable certification criteria adopted by the Secretary have been met and those EHR technologies are certified.” In addition, ONC notes that “The eligible health care provider would however be responsible for reconciling the data between those two certified capabilities for purposes of reporting to CMS or the States.”

Given the remaining ambiguity involved in the FAQ and its answer, we consulted with Jeff Ganiban, a partner in the health law group at the Washington, D.C.-based law firm Drinker Biddle and Reath LLP. As is the case whenever legal questions are involved, of course, it is important to consult with one’s own attorneys and consultants. But broadly speaking, the perspectives of someone as steeped in these issues as is Ganiban are always welcome. Ganiban spoke recently with HCI Editor-in-Chief Mark Hagland regarding this specific question; below are excerpts from their interview.

Healthcare Informatics: What’s your general interpretation of this FAQ and its answer from ONC?

Jeff Ganiban: If you have a vendor with an EHR that has been certified as a complete EHR, you cannot just buy pieces of it, like, say medication reconciliation; and assume that the pieces have been certified as modules. The reg and FAQs make it clear that just because a vendor has gotten complete EHR certification, they’ve not received modular certification for each module.

HCI: But you can use a separate ED module if you also buy a complete solution that includes its own ED module as well, correct?

Ganiban: Yes, according to FAQ 9-10-014-1, you could. This FAQ has two questions, but the answer focuses on the question of using duplicative functionality. The answer to this FAQ is that you can have duplicative or overlapping technologies so long as both technologies have been certified. Consequently, an eligible hospital can use both systems in different parts of the organization. You can extrapolate from this answer that you would have to possess the EHR that has been certified as a complete EHR, but can implement an ED system that is certified as an EHR module.

HCI: The underlying assumption otherwise would be that the federal government would be condoning the devastation of all niche vendors in healthcare IT, if one were in effect actually banned from using any niche vendors.

Ganiban: I think some vendors are taking advantage of the complete EHR certification to require customers to purchase their entire system, even though ONC and HHS have indicated that you just have to ‘possess’ a certified complete EHR or a bundle of certified modules that together would provide all of the required certified functionality. . .In the response to FAQ 12-10-21-1, the regulators say “We consider ‘possession’ of certified EHR technology to be either the physical possession of medium on which a certified complete EHR or combination of certified EHR modules resides, or a legally enforceable right by an eligible health care provider to access and use, at its discretion, the capabilities a certified complete EHR or combination of certified EHR modules includes. An eligible health care provider may determine the extent to which it will implement or use these capabilities, which will not affect the provider’s ‘possession’ of certified EHR technology. While we recognize that eligible health care providers may enter into various business arrangements depending on their particular needs and circumstances, we would expect that such arrangements could potentially include agreements with EHR technology developer(s) to access and use the capabilities included in Certified EHR Technology. Further, that these business arrangements could make an eligible health care provider’s payment for a particular capability contingent on its use or implementation of that capability in a production environment or the provider’s request for maintenance or technical support...”

HCI: In other words, some vendors are taking advantage of remaining ambiguities around the term ‘possession,’ and what it really means.

Ganiban: Yes, it seems so, so one needs to understand these nuances.