Implementation dates originally set for November have been delayed until April 2021, but more time is needed to meet compliance
Dec. 4, 2020 (ACP) – The American College of Physicians is urging the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT (ONC) to further delay the compliance dates set for new information-blocking regulations until the end of 2021 or as long as the COVID-19 pandemic impacts a practice's ability to comply with the changes.
Information blocking is defined as anything that interferes with, prevents or discourages access to or exchange of electronic health information. To prevent this practice and still protect health data, ONC set regulations into place via the Cures Act Final Rule. The regulations include new health IT certification requirements to enhance patients' smartphone access to their health information at no cost through the use of application programming interfaces.
In late October, ONC announced it would delay changes slated to go into effect in November 2020 until April 2021 due to the ongoing impact of the COVID-19 pandemic. ACP advocated for and supported this initial postponement. However, there is still more that practices must do to comply with these changes, and the new timeline does not allow for these adjustments, especially as practices continue to grapple with the devastating effects of COVID-19, said Brooke Rockwern, ACP senior associate of health IT policy.
In a letter to ONC National Coordinator Dr. Donald Rucker, Dr. Zeshan Rajput, chair of the ACP Medical Informatics Committee, says that the new timeline is not feasible for multiple reasons. It requires clinicians to provide all data in the U.S. Core Data for Interoperability (USCDI) under the information-blocking provisions (now April 5, 2021) before health IT vendors are required to provide the capability in their certified electronic health record (EHR) systems to support it (now Dec. 31, 2022). ACP urges ONC to align these timelines. Alternatively, ACP suggests that if a clinician's system is not capable of delivering all USCDI data, ONC should allow the clinician to be recognized as having met the requirements for one of the information blocking exceptions such as the “infeasibility exception,” Rajput writes in the letter. Moreover, ACP encourages ONC to specify the documentation required of clinicians requesting this exception.
In October of 2022, the scope of electronic health information expands to include more than the USCDI, and the onus is on ONC to provide clear guidance and complete certification criteria on what data it expects to be included in the full definition of electronic health information. ONC must do so well in advance of physician applicability dates and health IT vendor compliance dates, Rajput writes in the letter.
Rajput also points out that no specific steps have been outlined to ensure compliance, which means it would be up to practice groups that are already overtaxed by pandemic response and shrinking resources. ACP encourages ONC to develop comprehensive guidance on implementation and compliance with these regulations to share with practices.
In addition, Rajput writes, clearer regulatory guidance about how and what types of information-blocking claims will be assessed are needed from ONC and other relevant agencies.
There is a lot that practices can do to prepare for these new regulations in the meantime, Rockwern said. For starters, practices should review or develop internal data requests and exchange workflows. These processes may differ based on a practice's size and scope. “Larger practices may already have a compliance officer or health information management group,” Rockwern said. “A good first step is to focus on data exchange workflows specific to patient data requests and how long it takes to turnover those requests. The patient-facing side is the main driver for these changes, and it is important that all clinicians and staff within the practice are on the same page and not inadvertently blocking data.”
Rockwern advises that practices talk with their EHR vendors to see if they are on track to provide the functionality needed to meet the information blocking requirements. Practices won't necessarily need to buy new EHR systems because many vendors are updating systems to meet the new certification requirements. “As with any system upgrade there is likely an additional cost depending on the system,” she said.
Although the College continues to advocate for further delay of the information blocking compliance dates, ACP is currently developing resources to help practices with the transition, Rockwern said.
The letter with all of the recommendations offered to the ONC is available on the ACP website.