HITPC: The thinking behind the proposed rule for 2015 edition CEHRT

The Certification & Adoption Workgroup shared much of its reasoning behind the proposed rule for the 2015 Edition of EHR technology certification criteria, which was published in February. The Department of Health & Human Services accepted public comments until April 28.

During the May 6 Health IT Policy Committee meeting, Larry Wolf, co-chair of the workgroup, said the group considered two main questions:

• How do we achieve the goal of a Learning Health System and the Triple Aim using policy levers that make a difference and technology that has proven value?
• What is the role for the ONC certification program?

The proposed rule tried to follow along the Office of the National Coordinator for Health IT’s goal to ease the burden of regulations by having more incremental progress through more frequent notices for proposed rulemaking.

That could backfire, however. “We’re concerned about false signals,” said Wolf. “Too many interim steps can became dead ends, spinning up a lot of work that in the end didn’t go beyond the initial regulatory cycle.” The Work Group also heard from one software development organization that cost estimates are low compared to what they spent to get their products certified.

Overall, the workgroup did not think certification was the appropriate avenue to explore innovations. They want to “support pilot programs, continue efforts within the Standards & Interoperability Framework and build on innovations in the marketplace. We want to encourage the innovations already happening but we’re not locking in things that are not ready for prime time.” Certification often is prescriptive and overly burdensome, the workgroup said, and in and of itself it will not incline technology developers to enter the field.

The workgroup also spent a lot of time discussing the definition of a complete EHR, Wolf said. Having the certification bodies represented probably would have been good as well. “We struggle between what we want and what we can deliver. Providers would like to know they have everything they need on a technical level to achieve Meaningful Use.”

Providers value components that work well together, Wolf said. That interoperability is implied by a complete EHR “although, depending on the actual construction of the EHR, it might not be well integrated.”

The workgroup considered certification packages which was “an interesting swing in our thinking,” said Wolf. Naming of modules can cause confusion. It’s hard to define package titles but “having a way to lump modules would be a good thing.”

The workgroup also contemplated the ONC certification mark. “A singular certification mark is beneficial for consumers by providing certainty, clarity and confidence that the product they’re buying is certified.” It could, however, lead consumers to assume the product is for Meaningful Use. Vendors have voiced concerns about the proposal’s clarity regarding requirements for use of the mark.

The proposed rule includes four additional data elements for collection: disability, sexual orientation and gender identification, occupation and military data. “We probably need to expand the set of data that our tools let us slice and dice by,” Wolf said. These new categories could be valuable for assessing health disparities and can be very helpful for care. A history of exposure to workplace hazards, for example, can help guide treatment. Some of the information isn’t relevant to the process and therefore probably “shouldn’t be on the demographic sheet which is usually very available, easily distributed and published,” Wolf said.

In other discussions about datasets and coding, the workgroup acknowledged that “having a good technical structure isn’t obvious. We have to get the details right before we rollout the methodology.” The group talked about Blue Button+, for example. While there are great examples of it being used well and people getting value out of it, it’s premature to consider including it in certification requirements, he said.

The workgroup also needs to find better ways to learn more about low adoption rates. Is it due to consumers not caring or is it too complicated? They want to do more exploration and allow the marketplace to innovate, Wolf said. To the extent to which evidence exists, “certification becomes a great way to communicate to consumers.”

Several members of the Health IT Policy Committee shared thoughts after Wolf’s presentation. “We need to determine the role of certification,” said Representative Gayle B. Harrell (Fla.-R), Member, Florida State House of Representatives. “That’s the conversation we need to have. Within the legislation you need interoperability, the ability to communicate and transfer information. That’s what to me the basic conversation of certification needs to start around and the workgroup needs to have that focus.” Rulemaking is implementation of legislation, she said, so the conversation has to center around what a provider needs to meaningfully use a certified product.

“Certification has been very good for breadth,” said David W. Bates, MD, MSc, senior vice president for quality and safety and chief quality officer for Brigham & Women's Hospital in Boston. Certification led vendors to add many pieces of functionality that might have taken them much longer otherwise. We’re at a transition point, he said, now that people have adopted the technology. “Now we want to know how to use it to really make things better.”

“Many things in the 2015 edition have never been used,” said software entrepreneur Paul Egerman. “We can’t have that when the implementation guide hasn’t even been published yet.” He referred to concepts “totally new for EHR systems” like the unique device identifier. “Certification is not the right tool by itself to do that. The iPhone was not created through the regulatory certification process.” Other vehicles need to come before certification, he said, including on-the-ground, nationwide testing to find out if something works before a national rollout. “Once you do that, the expense is dramatic.”

The workgroup will consider public comments as it prepares the final rule on the 2015 edition of certified EHR technology.