Last month we decided to make some predictions on what we thought the EOA Final Rule would contain given its NPRM, comments received, and our experience with ONC. How did we do? Read on below.
Direct Review Predictions
Predictions were generally right on. Most notably, ONC did not make significant changes from their proposal as we predicted. However, we mentioned they would go extra lengths to reassure EHR developers that they will be very fair, and they definitely did this at several places. They added some clarification on how ACBs will work with ONC on direct reviews as predicted. While still separate surveillance efforts, you do get a better sense of how ONC and ACBs will coordinate if necessary. We thought they would increase the time allotment for responses and appeals and they did that. They added the ability for developers to request an extension to submit CAP material as well as changing the 10-day period to file an official appeal to a 10-day period to file their intent to appeal with the appeal itself coming 30 days from this intent notification.
Public Availability of Identifiable Surveillance Results Predictions
As noted, this was a rule that ONC would implement essentially as is, and they did that. The only notable change from the proposal was hosting the links to surveillance on the CHPL rather than the individual websites of the ONC-ACBs, which is good choice.
Establishing ONC Authorization for Testing Labs Predictions
We took a risk in speculating the idea that we could see ONC make the change to allow non-NVLAP-accredited testing laboratories to submit similar test results to ATLs for evaluation and consideration. If there was ever going to be a rule to allow for this, this would be it, but ONC decided not to do that. They will retain oversight by requiring NVLAP-accreditation to be an ONC-ATL, and only accept test results from ONC-ATLs. Other labs will have to follow this process to utilize their testing programs. However, they are allowing accreditation for just one criterion or even a subset of an individual criterion which enables niche-focused test labs to be accredited. Otherwise, everything came much like predicted (and proposed).