HHS-OIG’s New Health Information Blocking Rule: Covered Actors; Costly Violations; Federal Interagency Coordination

Description

On July 3, 2023, HHS-OIG issued a final rule (CMP Rule) that empowers the agency to impose CMPs of up to $1 million per violation for unlawful acts of information blocking in violation of the 21st Century Cures Act. Enforcement begins Sept. 1, 2023.

Under the CMP Rule, any health information network and exchange (HIN/HIE), health IT developer, or healthcare provider that meets the statutory definition of one of these actors, who knows, or should know, that it engaged in a practice that is likely to interfere with access, exchange, or use of electronic health information (unless an exception applies) may be subject to a costly CMP. This means that penalties may be imposed whether or not any actual interference occurs as long as the party has the requisite intent.

OIG's enforcement will be complaint-driven and involve coordination with other regulatory agencies where information blocking violations raise issues within the other agencies' purview. Therefore, counsel should ensure their clients' business practices are compliant across their organizations.

Although the CMP Rule does not apply to healthcare providers generally, counsel should determine whether their healthcare provider clients meet the statutory definition of a developer or HIN/HIE subject to CMPs. Additionally, counsel should be aware of an upcoming HHS proposed rule that would make healthcare providers subject to “appropriate disincentives” set forth by HHS.

Listen as our expert panel discusses the final CMP Rule including who qualifies as information blocking actors and how OIG will prioritize and enforce complaints. The panel will also address interagency cooperation and how it may impact regulated entities, as well as provide best practices for assisting clients with organizational compliance.