In response to the COVID-19 public health emergency, the Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) issued statements on enforcement discretion and delayed implementation on interoperability, information blocking, and patient access to data. The rules were previously released unofficially by the agencies last month [see Washington Highlights, March 13].Additionally, the HHS Office of the Inspector General (OIG) issued a proposed rule for civil money penalties (CMPs) for information blocking among other amendments to the CMP regulations. Highlights of these updates are provided below:
The ONC announced it will exercise discretion in enforcing all new requirements that have compliance dates and timeframes, providing an extension of three months from each initial compliance date or timeline in the final rule. Details of these enforcement discretion dates and timeframes can be found here.
CMS announced the agency is pushing back implementation of new Conditions of Participation (CoPs) for hospitals and Critical Access Hospitals to electronically transmit admission, discharge, and transfer (ADT) notifications and for certain payer interoperability requirements— each will be delayed by six months. The new CoPs will now be effective May 1, 2021. CMS will not enforce the payer interoperability and patient access policies until July 1, 2021.
The OIG 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 enforcement based on the ONC’s finalized information blocking rules; and (3) increased maximum penalties for certain violations.
On the new information blocking CMPs, the OIG expects to prioritize 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 21st Century Cures Act (P.L 114-255) prescribed CMPs up to $1 million per violation of the information blocking rules, but it notably excluded health care providers from being subject to the CMPs. The ONC will consider appropriate disincentives for providers in future rulemaking. For individuals and entities subject to the information blocking CMPs, the OIG proposes to delay enforcement until 60 days after the rule is final to allow time to come into compliance.
Comments are due June 23, 2020, and the HHS OIG will monitor requests to extend the comment period due to the ongoing public health emergency.