ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends
The Office of the National Coordinator for Health Information Technology (ONC) published noteworthy information blocking claim submission trends to date in its recent Information Blocking Claims: By the Numbers post on the Health IT Buzz blog.
For the purposes of its reporting, the threshold for a Report Information Blocking Portal submission to be counted as an information blocking claim by ONC is relatively low. ONC will count any potential to involve conduct implicating the definition of information blocking as an information blocking claim.
ONC added information blocking claims data visualization to its Quick Stats dashboard and will update the findings monthly moving forward. Since April 5, 2021, the applicability date of the Information Blocking Final Rule, ONC has received 299 information blocking portal submissions. Of that total, it deemed 274 to be information blocking claims.
Health care providers, health information networks or health information exchanges, and health IT developers of certified health IT are covered by the Information Blocking Final Rule (Information Blocking Actors). Anyone who believes they may have experienced or observed information blocking by any Information Blocking Actor may submit a claim to the portal. Patients (176 claims) were far and away the most prominent claimant type, followed by attorneys and third parties on behalf of patients (32 claims), and health IT developers of certified health IT (20 claims). Meanwhile, 211 of the 274 claims were against health care providers and 42 were against health IT developers of certified health IT. Health care providers were associated with the highest volume of claims (211) as potential Information Blocking Actors, and health IT developers of certified health IT were next with 42 claims.
ONC Enforcement Commentary
Along with reporting on claim submission trends, ONC offered reminders around its shared enforcement authority with the Department of Health and Human Services Office of Inspector General (OIG). ONC will share all submissions with OIG unless a submission described behavior that was by definition not information blocking. This would mean, for example, that there are no Information Blocking Actors or electronic health information (EHI) as defined in the Information Blocking Final Rule involved. While the 21st Century Cures Act (Cures Act) allows OIG to investigate any information blocking claim and issue civil monetary penalties, ONC can independently review only claims against health IT developers of certified health IT pursuant to its governance of the Health IT Certification Program. ONC has the authority to issue notices of non-conformity and certification terminations or bans to these developers.
In a separate February 2022 FAQ, ONC also discussed two examples of laws where non-compliance with other laws could lead to enforcement under the Information Blocking Final Rule. First, the Centers for Medicare & Medicaid Services (CMS) Interoperability and Patient Access Final Rule (Interoperability Rule) requires that certain health care provider types send electronic patient event notifications of a patient’s admission, discharge, and transfer (ADT) to other health care providers. According to ONC, health care providers’ failure to send ADTs as required by the Interoperability Rule may also be considered non-compliance with the Information Blocking Final Rule. Additionally, if an Information Blocking Actor is required to otherwise provide EHI to public health authorities and it fails to do so, it may be deemed interference under the Information Blocking Final Rule.
ONC cited in its blog post examples of both patients and health care providers reporting excessive fee charges and unnecessary delays in accessing and receiving EHI. It added that some of these types of claims “appear on their face consistent with examples of practices likely to interfere with access, exchange, or use of EHI that we described in ONC’s Cures Act proposed and final rules”. While ONC said it is unable to determine through “simple triage” whether claims represent information blocking as defined in the regulations, it discussed the central tenets of any information blocking investigation. ONC stated that any investigation would depend on whether an individual or entity engaging in a practice is an Information Blocking Actor as defined in 45 CFR 171.102 and had the applicable knowledge standard; the practice rose to the level of an interference as defined in 45 CFR 171.102; the practice involved EHI as defined in 45 CFR 171.102; and practice was required by law or was covered by an exception to the definition of information blocking.
Potential claimants and Information Blocking Actors will likely find value in ONC’s insight and reporting on the volume of claims, the types of claimants and potential Information Blocking Actors, and its approach to investigations. However, some questions around how ONC or OIG would ultimately enforce information blocking claims continue to linger. For example, what types of fees in response to information requests would be considered excessive and what would be considered a legitimate delay versus a tactical impediment to receiving information? Additionally, considering ONC counted health IT developers of certified health IT as the second-most likely type of potential Information Blocking Actor and it has the authority to investigate these actors independently, what specific types of developer actor behavior would warrant ONC investigation and enforcement actions?
Until changes to the amend the Civil Monetary Penalty Law rules are finalized (see our December 29, 2021 blog post) and OIG or ONC announce specific enforcement actions with details around Information Blocking Final Rule violations, potential claimants and actors will have to wait to see how the agencies approach enforcement.