ONC Releases Report, Commentary on Information Blocking Rules Complaint Trends | Mintz – Perspectives on Health Care

The Office of the National Health Information Technology Coordinator (ONC) has released some remarkable information on claims submission trends to date in its recent Information Blocking Claims: By the Numbers article on the Health IT Buzz blog.

For its reporting purposes, the threshold for a report information blocking portal submission to be counted as a request to block information by the ONC is relatively low. The ONC will consider any potential to involve conduct involving the definition of information blocking as an information blocking claim.

ONC has added information blocking the viewing of claims data to its Quick Stats dashboard and will update the results monthly going forward. Since April 5, 2021, when the information blocking final rule became effective, ONC has received 299 information blocking portal submissions. Of that total, he estimated that 274 were requests to block information.

Health care providers, health information networks or health information exchanges and certified health informatics developers are covered by the information blocking final rule (blocking actors information). Anyone who believes they have experienced or observed information blocking by an information blocking actor may submit a complaint to the Portal. Patients (176 claims) were by far the largest claimant type, followed by lawyers and third parties on behalf of patients (32 claims) and certified healthcare IT developers (20 claims). Meanwhile, 211 of the 274 claims were against healthcare providers and 42 against certified healthcare IT developers.

Meanwhile, healthcare providers were associated with the highest volume of complaints (211) as potential information blocking actors, and certified healthcare IT developers followed with 42 complaints.

ONC Law Enforcement Commentary

In addition to reporting on claims submission trends, the ONC offered reminders regarding its shared enforcement authority with the Office of Inspector General (OIG) of the Department of Health and Human Services. The ONC will share all submissions with the OIG unless a submission describes behavior that, by definition, was not information blocking. This would mean, for example, that there are no information blocking or Electronic Health Information (EHI) actors as defined in the Information Blocking Final Rule involved. While the 21st Century Salaries Act (Salaries Act) allows the OIG to investigate any information blocking claims and impose civil monetary penalties, the ONC cannot independently review that claims against certified health IT developers in accordance with its governance of the health IT certification program. ONC has the authority to issue notices of non-compliance and termination or denial of certification to such developers.

In a separate FAQ from February 2022, the ONC also discussed two examples of laws where failure to comply with other laws could result in enforcement under the final information blocking rule. First, the Centers for Medicare & Medicaid Services (CMS) Patient Access and Interoperability Final Rule (Interoperability Rule) requires certain types of healthcare providers to send electronic patient event notifications regarding the admission, discharge and transfer (ADT) of a patient to other healthcare providers. According to the ONC, the failure of healthcare providers to send ADTs as required by the interoperability rule may also be considered a violation of the final information blocking rule. Additionally, if an information blocking actor is required to otherwise provide EHI to public health authorities and fails to do so, this may be considered interference under the final information blocking rule. information.

Discussion

The ONC cited examples in its blog post of patients and healthcare providers reporting excessive charges and unnecessary delays in accessing and receiving EHI. He added that some of these types of allegations “appear at first glance as examples of practices that may interfere with the access, exchange or use of the EHI that we have described in the proposed law. on ONC Treatments and Final Rules”. While the ONC said it was unable to determine through “simple triage” whether the claims amounted to information blocking as defined in the regulations, it discussed the central principles of any investigation of information blocking. The ONC said 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 has the applicable standard of knowledge; the practice has risen to the level of interference as defined in 45 CFR 171.102; the practice involved the EHI as defined in 45 CFR 171.102; and the practice was required by law or covered by an exception to the definition of information blocking.

Potential information blocking claimants and actors will likely find value in ONC’s information and reports on the volume of claims, types of potential information blocking claimants and actors, and its approach. investigations. However, some questions about how the ONC or OIG would ultimately enforce information blocking requests continue to persist. For example, what types of charges in response to requests for information would be considered excessive and what would be considered legitimate delay versus a tactical impediment to receiving information? Additionally, given that the ONC has counted certified health informatics developers as the second most likely type of potential information-blocking actor and has the authority to investigate such actors in a independent, what specific types of developer actor behavior would warrant investigation and enforcement action?

Until changes to the Civil Monetary Penalties Act Rules Amendment are finalized (see our December 29, 2021 blog post) and the OIG or ONC announces specific enforcement actions with details of violations of the information-blocking final rule, potential plaintiffs and actors will have to wait to see how the agencies approach enforcement.

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