Section 4004 of the 21st Century Cures Act of 2016 expanded the United States Department of Health and Human Services (HHS) authority to investigate and penalize information blocking. Regulatory implementation is incomplete and delayed until April 5, 2021, however, the American College of Radiology® (ACR®) has received several similar questions about the May 1, 2020 rule published by the HHS Office of the National Coordinator for Health IT (ONC). Specifically, imaging providers wish to understand whether it would be “information blocking” to keep their normal communication policies of releasing radiology reports on patient portals following a short interval of time intended to facilitate care coordination, consultation, closing the referral loop, direct discussion of complex findings or any other purpose widely considered medically appropriate by physicians. Interpretations may vary.
Generally, any unnecessary delay in access, exchange or use of electronic health information (EHI) would almost always implicate the information blocking provision. However, implicating the provision does not mean a specific practice rose to the level of an interference and that the actor acted with the requisite intent for it to be penalized as information blocking. Rather, each reported instance will be investigated by HHS on a case-by-case basis, informed by facts and circumstances. Future enforcement will likely be somewhat iterative, with the outcomes of prior investigations informing HHS’ handling of similar scenarios.
Multiple HHS offices and agencies are responsible for implementation of the information blocking provision. As of this writing, only ONC has promulgated a final rule. ONC’s primary role with respect to this provision is to define reasonable and necessary exceptions to information blocking. The eight ONC-defined exceptions provide stakeholders with a level of certainty, though are not exhaustive in terms of delineating what will and will not be penalized.
Each reported practice that a) implicates the information blocking provision and b) does not meet the criteria of an ONC-defined exception, will be individually analyzed during HHS investigations to evaluate whether it rose to the level of an interference and whether the actor acted with the requisite intent, among other considerations. Cures Section 4004 defines information blocking such that providers must “know that a practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI.” It is currently unknown whether HHS investigators would view providers’ medically appropriate patient communication policies as meeting the information blocking definition if reported in the future.
Due to ambiguity and varying interpretations, the ACR filed a request with HHS Sept. 2020 seeking clarification on how investigators would handle this specific issue if ever reported. As of Oct. 23, 2020, HHS has not yet officially responded to the request from the ACR. It could take some time, particularly as the program is delayed. The ACR will alert the community as soon as more information is available.
Why are there varying interpretations of the report access issue?
Implementation of the information blocking provision is still incomplete, and ONC’s May 1 rule deferred to other HHS agencies on most enforcement considerations. As such, there are few HHS-developed guidance documents and other first-party resources to guide actors’ planning.
Perhaps more importantly, non-provider-actors are subject to a more stringent statutory definition of “information blocking” and a different penalty structure. Non-provider-actors simply “should know” a practice is a likely interference, etc., whereas provider actors must know the practice is both unreasonable and a likely interference, etc. As currently implemented in ONC’s May 1 rule, it is possible that providers could meet the definition of a different actor type (e.g., “developer of certified health IT” or “health information network/exchange”), and be penalized as such when acting in that capacity. Major healthcare institutions concerned about meeting one of the two non-provider actor definitions may or may not be approaching compliance differently than providers without this concern.
Do providers need to acquire new technologies?
There is an infeasibility exception for those without the capability to satisfy a request for access, exchange or use of EHI, provided the requisite criteria of that exception are met.
Does immediate release of report data to patients ensure comprehensive information blocking compliance?
The information blocking provision is not exclusive to radiology report data or even to patient access considerations; it is broadly applicable to all relevant data availability scenarios involving EHI, including provider-to-provider exchange. For instance, failing to respond appropriately to another provider’s request to establish access, exchange or use of EHI would implicate the information blocking provision. Likewise, if a developer of certified health IT is charging unreasonable, opportunistic fees to add an unaffiliated radiology provider to their system’s order entry list, the information blocking provision would be implicated. These are just two of many examples.
Additionally, regardless of a provider’s preference that patients use an online portal solution for accessing EHI, this may not always ensure an individual request is appropriately responded to. A portion of ONC’s May 1 rule deals with processes for how actors should appropriately respond to requests for access, exchange or use of EHI.
Are timed release policies for practice of medicine purposes discussed in the ONC’s rule?
These policies are discussed to a limited degree. Some relevant highlights include the following discussions:
- The concept of what is “timely” access to EHI was left intentionally unclarified to allow for case-by-case determinations.
- ONC did not explicitly exempt practice of medicine reasons for delaying EHI access under any of the eight exceptions.
- Timed release policies would specifically be unable to be exempted under the auspices of the Preventing Harm exception, as patient misinterpretation, confusion and anxiety would not meet the harm standard required by the criteria of that exception.
- The Preventing Harm preamble in the rule also opined that deference should generally be afforded to patients’ right to choose whether to access their data as soon as it is available or to wait for a provider to contact them to discuss their results. It was ambiguous on choice determination and if appropriate responsiveness to individual requests would be sufficient.
- Elsewhere, ONC’s rule discussed that specific data points — such as results pending confirmation or otherwise in progress — may not be appropriate to disclose or exchange until finalized. It was more ambiguous on when report data is considered final if potentially subject to further change.
Where can readers find more information?
ACR members with questions can contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at email@example.com
Note: This news article is intended for general information purposes only. It is not to be used for compliance or as regulatory guidance of any kind.