The overall reaction from the health IT community to the final interoperability rules published March 9 has been largely positive, yet stakeholders are voicing concerns about timelines and provider organization burdens. Of particular concern are the time hospitals have to begin doing patient event notifications (six months) and the time EHR vendors and provider organizations have to implement changes related to standards-based application programming interfaces (two years).
Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA), stressed that the admission, discharge and transfer (ADT) notifications requirement from CMS is an important policy. Getting more consistent visibility into where and when patients are moving is really important, he said, but the timeline and mechanism are open to criticism.
“Six months to get this kind of functionality going without creating more problems and burdens than it solves will be interesting,” he said. “The fact that they are still making this a condition of participation for Medicare and Medicaid means this is a really big deal, but the growing pains are going to be pretty substantial and they are going to come pretty quickly. We just don’t have a consensus yet on how to manage these alerts. One could easily envision a situation within a small to medium size physician practice, if not orchestrated properly, faces a deluge of alerts. Presumably most would be good things to know about your patients,” he added, “but if you are a primary care physician and have 500 patients and you are not currently receiving ADT alerts, you could see this as a big issue to deal with.”
Meryl Bloomrosen, senior director of federal affairs for the Premier health alliance, agreed with Smith’s assessment. “We are disappointed that CMS has chosen to go forward to make that a required condition of participation in Medicare,” she said. “We are very supportive of the ADT notification function, but we and other provider groups had recommended that it be built into the ONC certification program or the functionality of an EHR rather than the significant penalty of being kicked out of Medicare if a hospital can’t do ADT notifications.” She said Premier is disappointed that the requirement goes into effect in six months. “Six months is not a lot of time, particularly with what we are going through right now with the coronavirus. Maybe there will be some thinking about that. That is an unnecessary burden right now.”
AMIA’s Smith added that with that six-month time horizon, most hospitals and payers are going to have to raise this up to close to their No. 1 priority, just because the other things ONC has going on are on longer timelines.
Two-Year Timeline on APIs
Speaking further about provider burden, Bloomrosen pointed to the fact that ONC is maintaining a two-year implementation timeline for updates to EHRs for APIs and requiring vendor development and provider adoption all within a two-year window.
“We had recommended they give EHR vendors x amount of time, and then give providers an additional amount of time, say 12 months, to implement and test. Again, this is going to be a provider burden.”
AMIA’s Smith saw this as problematic as well. He explained that ONC is trying to address a problem it has encountered over the course of the last 10 years. Traditionally, they establish a timeline that vendors need to have new certified functionality available, and then CMS dictates a deployment timeline for providers. So there is always a technology adoption lag of a few years. “What they are saying is that we are going to force vendors to develop and clients to adopt within 24 months,” Smith stressed. “ONC is now positioned to dictate adoption timelines for hospitals. Historically it has been CMS payment policies that dictate adoption. I am not comfortable with that. We are going to run into an issue where hospitals and physician practices are not going to be happy about the fact that they and EHR vendors are on the same timeline. I worry that it is going to create additional problems or could align forces – EHR vendors and hospitals – to successfully advocate for delays. They are both in the same boat and they will both definitely want delays.
EHI Export
On the certification side, a new EHI Export rule requires that a single patient be able to access through some export function all their electronic health information. “What this means in practical terms is an open question, but it is a positive step forward,” Smith said. “In December 2018, we, along with AHIMA, talked about the need to have convergence between HIPAA right of access and health IT certification. What we said is there needs to be an ‘EASY button’ that providers can push that would deliver the data for patients on HIPAA right of access. EHI Export will get us much closer to that, but how it gets implemented remains to be seen.”
FHIR
The ONC rule called for the use of FHIR Release 4 and the FHIR bulk data standard for population health purposes. “That bulk data component caught me by surprise,” Smith said. “There is a good chance it will find very important use cases, but we don’t have widespread experience with it. That will be an area of technical development to watch and to see how it develops. I was surprised to see it in there, but it will be an important functionality.”
Gag Clauses
One thing the certification requirement addresses involves “gag clauses” that keep provider organizations from sharing screen shots due to intellectual property protection concerns. Many informaticians have argued that this slowed work on clinical decision support and patient safety efforts. “ONC should be applauded for saying, we don’t know how pervasive the problem is but it can’t go on,” Smith said. “I think establishing a policy that says that as a user of an EHR system I can talk about my experiences is important.”
Bloomrosen said it is an important change from the perspective of patient safety and improving the functionality of EHRs. “Users and clients of EHR vendors could not share a photo of a screen with another practitioner to ask how they could change this to make it safer,” she said. “I think it is potentially a big deal.” Tied to that, ONC has been required by the 21st Century Cures Act to implement an EHR reporting program, but they are not implementing it yet. That may be tied to this question about gag clauses, she said. “The reporting program is supposed to help with things like improving EHR functions and making them safer and more usable.”
Bloomrosen added that the ONC and CMS rules are focused on the administration’s goal of unlocking data for patients and consumers. “We are highly supportive of that,” she said, “but we also want to make sure that hospitals and doctors can implement third-party apps of their choosing without having to go through too many rules that the EHR vendors set. We are cautiously optimistic and encouraged that the ONC language seems to include more attention to provider needs, not just consumer needs. We didn't feel that from the proposed rule.”
