Information blocking complaints roll in, but enforcement lags behind

ONC is processing claims, but the HHS’ Office of the Inspector General still needs to put rules in place delineating enforcement and penalties.

Claims contending information blocking are being filed with the government, but action against most alleged violators is on hold until rules implementing consequences can be finalized.

The 21st Century Cures Act puts the responsibility on the Office of the National Coordinator of Health IT (ONC) to create a standardized process for the public to report claims of possible information blocking by health IT developers, health information networks and exchanges, and providers. 

ONC created an Information Blocking portal on which claims can be reported. ONC performs a form of triage to see if the claim meets the definition of information blocking, according to Michael Lipinski, Division Director for ONC’s Regulatory and Policy Affairs Division with ONC’s Office of Policy. ONC confirms receipt with the submitter and assigns the claim a tracking number.

ONC's Information Blocking Portal

OIG’s enforcement responsibility

But ONC is not in charge of investigating most information blocking claims. That falls to HHS’ Office of Inspector General (OIG), which has the authority to investigate claims against all actors subject to the Cures Act.

As a result, ONC shares with OIG – typically within two days – the claims it receives through the portal. “Then, it’s up to OIG in how they process claims,” says Lipinski.

ONC does have dual oversight and can investigate claims when it comes to health IT developers of certified health IT because of the requirement of the ONC Health IT Certification Program that vendors wanting their products certify not engage in information blocking.

However, unlike OIG, which has the authority to impose civil monetary penalties on health IT developers and HINs/HIEs and “disincentives” on providers, ONC’s approach is not punitive.

“It’s more about corrective action,” says Lipinski.

Investigations are not limited to claims received via the portal. They could also arise during ONC or OIG investigations or from a report directly to OIG.

Most complaints name providers

Since April 5, 2021, the date ONC’s information blocking rule went into effect, 369 claims have been reported via ONC’s Information Blocking Portal. Of those, 341 are possible claims of information blocking. More than 75 percent of the claims are against providers.

There have been 47 claims filed against health IT developers listed in the Certified Health IT Product List (CHPL), eight against developers not on the CHPL, and two against health information networks or health information exchanges.

The data is updated monthly.

Enforcement is a work in progress

Neither ONC nor OIG will provide information on any ongoing investigations, says Lipinski.

But we do know that OIG cannot yet impose any enforcement action because it has not finalized the rules that would enable it to do so. The agency still needs to issue a final rule establishing civil monetary penalties against developers and HINs/HIEs that engage in information blocking. The proposed rule was issued in April 2020; the final rule was originally expected in March 2022, says Lipinski.

And the OIG has yet to issue a proposed rule addressing disincentives against providers, which the Cures Act delegated to the Secretary of HHS.

HHS has indicated that information blocking enforcement is a priority.

There are additional questions surrounding OIG’s enforcement of the information blocking rules. For instance, the 2020 proposed rule noted OIG’s expected priorities for enforcement actions. They included investigating conduct that resulted in, is causing or has the potential to cause patient harm; significantly impacted a provider's ability to care for patients; was of long duration; caused financial loss to federal health care programs or other government or private entities; or was performed with actual knowledge.

It is not yet known whether these priorities have shifted. The proposed rule notes that OIG expects its enforcement priorities to “evolve” as OIG gains more experience investigating information blocking.

Also unknown is whether OIG will use enforcement discretion regarding information blocking that occurred before the final rule is issued. OIG asked for feedback regarding that issue.

What is clear is that ONC and OIG are committed to working as a team in their efforts to battle information blocking. “ONC and OIG each have jurisdiction and can rely on each other. The statute expects OIG and ONC coordination,” says Lipinski.

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