OIG proposes rule for civil money penalties for information blocking
WASHINGTON-The Department of Health and Human Services (HHS) Office of Inspector General (OIG) proposed a rule amending civil money penalty (CMP) regulations today.
The proposed rule would incorporate statutory changes in three areas: (1) new authorities for CMPs, assessments and exclusions related to HHS grants, contracts and other agreements; (2) new CMP authorities for information blocking; and (3) increased maximum penalties for certain violations.
The proposed information blocking enforcement regulations are intended to help improve coordination within the health care system and patients' access to their health care data by addressing the negative effects of information blocking. OIG is seeking comment on when information blocking enforcement should begin.
"OIG is working to meet its mission while minimizing burdens on providers and being flexible where possible during the COVID-19 public health emergency," said Christi A. Grimm, HHS-OIG Principal Deputy Inspector General. "When implemented, the new CMPs for information blocking will be an important tool to ensure program integrity and the promised benefits of technology and data."
Individuals and entities subject to the information blocking CMPs would have time to come into compliance with any final regulations. At a minimum, enforcement would not begin sooner than the compliance date for the ONC Final Rule established in 45 CFR § 171.101(b). OIG has proposed to delay enforcement until 60 days after its rule is final. Commenters are encouraged to submit comments regarding how the COVID-19 pandemic and other considerations should affect information blocking enforcement time frames.
The proposed rule would not impose new information blocking requirements. OIG proposes incorporating regulations recently published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking CMPs.
In the proposed rule, OIG provides examples for how it would determine single or multiple violations of the information blocking provision for individuals and entities subject to OIG's CMPs, such as health information technology developers. Additionally, OIG explains that information blocking determinations require determining if actors had the right level of intent.
"Health IT professionals and entities who make innocent mistakes will not be subject to CMPs," Grimm said. "As our proposed rule makes clear, each allegation of information blocking would be assessed based on its own merits given the unique facts and circumstances presented, including the intent of parties. That assessment will include close coordination with ONC and the HHS Office of Civil Rights."
The proposed rule announced today also highlights expected priorities for enforcement actions. Those priorities would include 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.
The proposed rule addresses two other statutory provisions. OIG proposes to incorporate new CMP authorities for fraud related to HHS grants, contracts, and other agreements into the OIG's existing regulatory framework for the imposition and appeal of CMPs, assessments, and exclusions. OIG also proposes to modify OIG's CMP regulations to adjust the maximum penalties for various CMP violations, in accordance with changes made by the Bipartisan Budget Act of 2018.
OIG is issuing the proposed rule with a 60-day comment period. OIG will monitor requests to extend the comment period due to the COVID-19 public health emergency.