On July 3, 2023, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) finalized its rule implementing civil monetary penalties for information blocking (IB), as authorized by the 21st Century Cures Act. As of September 1, 2023, OIG may impose penalties of up to $1 million per violation on certain entities – specifically:
In a separate rule, HHS established disincentives, rather than monetary penalties, for certain healthcare providers who commit IB. These apply to specific Medicare and Medicaid program participants and can affect:
ASTP receives and reviews complaints, and can also take enforcement action against Health IT Developers of Certified Health IT through the ASTP/ONC Health IT Certification Program (e.g., corrective action plans, suspension, or termination of certification).
OIG investigates violations and enforces penalties on rule breaking entities.
CMS applies disincentives to Medicare/Medicaid providers under its programs.
Through complaints filed by individuals or entities
To prioritize cases, OIG will focus on those that:
Source: OIG Website – https://oig.hhs.gov/reports/featured/information-blocking/
This resource does not constitute legal advice. Please consult with your legal counsel to determine whether the IB Rules apply to you or your organization and what compliance and enforcement might mean for you or your organization.
While enforcement is complaint-driven, OIG prioritizes investigations based on patient harm, impact to care, or willful violations. Organizations that can demonstrate a proactive compliance posture are better positioned in the event of an investigation, or to prevent violations in the first place.
Establish or update an (IB) Compliance Program that includes:
Here are some tips to ensure your organization is ready in the event of an investigation. Note that The Sequoia Project has an array of resources available that provide much more detail on strategies for IB compliance. Information Sharing Workgroup Resources – The Sequoia Project.
Gather information about the request that triggered the investigation and identify the scope of those requests (if possible)
Maintain a posture of cooperation with investigators, while documenting all interactions and an inventory of documents shared
Follow generally accepted practices for retention and maintenance of records
Not all actor types have the same capabilities for readiness and response. The following section provides more tailored tips by organization type and size.
Key Readiness Focus: Ensure enterprise-wide consistency in IB policies; centralize logging and audit capabilities.
Key Response Steps:
Key Readiness Focus: Use ASTP/ONC tip sheets and FAQs; assign a compliance lead even if part-time
Key Response Steps:
Key Readiness Focus: Align product documentation and customer agreements with IB requirements
Key Response Steps:
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