HHS OIG Releases Final Rule for Information Blocking Penalties

The HHS Office of Inspector General (OIG) has released a final rule establishing the statutory penalties created by the 21st Century Cures Act information blocking requirements.

The final rule does not impose new information blocking provisions. OIG incorporated regulations published by ONC as the basis for enforcing information blocking penalties.

If OIG finds that an individual or entity has committed information blocking, they may be subject to up to a $1 million penalty per violation.

"Information blocking poses a threat to patient safety and undermines efforts by providers, payers, and others to make the health system more efficient and effective," OIG officials wrote in the final rule.
"Information blocking may also constitute an element of a fraud scheme, such as by forcing unnecessary tests or conditioning information exchange on referrals."

"Addressing the negative effects of information blocking is consistent with OIG's mission to protect the integrity of HHS programs, as well as the health and welfare of program beneficiaries," they added.

The document will not be official until it is published in the Federal Register. Most of the final rule provisions will go into effect 30 days after that publication date.

This final rule addresses civil monetary penalties for practices that are "likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI) if the practice is conducted by an entity that is: a developer of certified health information technology (IT); offering certified health IT; a health information exchange (HIE); or a health information network (HIN), and the entity knows or should know that the practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of EHI.

OIG expects to receive more information blocking complaints than it can investigate. To triage allegations and allot resources, OIG will prioritize cases for investigation that:

• resulted in, is causing, or had the potential to cause patient harm
• significantly impacted a provider's ability to deliver patient care
• were of long duration
• caused financial loss to Federal healthcare programs or other government or private entities
• were performed with actual knowledge