Key Takeaways | Information Blocking: Defense of Cures Act Investigations and Enforcement - McDermott Will & Emery

Key Takeaways | Information Blocking: Defense of Cures Act Investigations and Enforcement


On the eve of the one-year anniversary of the US Department of Health and Human Services (HHS) Office of Inspector General’s (OIG) publishing its final rule implementing its 21st Century Cures Act authorities to investigate claims of information blocking (IB) and impose penalties on certified health IT developers and health information networks and exchanges, HHS published its final rule for “appropriate disincentives” for healthcare providers who engage in IB. Now, it is only a matter of time before we start to see evidence of active enforcement. During this webinar, Daniel Gottlieb, James Cannatti and Mark Pearlstein outlined the OIG’s IB authorities, the disincentives set forth in the final rule and strategies to prepare for OIG investigations and HHS enforcement.

Top takeaways included:

  • Analyze potential appropriate disincentive enforcement impact. Under the new appropriate disincentives rule, penalties for non-compliance are limited to providers enrolled in certain Medicare programs, and the type and impact of the penalty vary by the program. The disincentives have varying effective dates, based on the Medicare program. Disincentives associated with hospitals and critical access hospitals (CAHs) as well as clinicians reimbursed under the Physician Fee Schedule (PFS) go into effect 30 days after the rule is published to the Federal Register, while disincentives associated with the Medicare Shared Savings Program do not go into effect until January 1, 2025.
  • Preparation is key to avoid disincentives and penalties. Companies and providers subject to the IB prohibition should review their existing information blocking policies and procedures and evaluate potentially applicable information blocking exceptions, including the amended information blocking exceptions in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule promulgated by the HHS Office of the National Coordinator for Health IT in January 2024.
  • Have a plan for OIG engagement. Entities that are the subject of OIG investigation for IB should appoint experienced counsel to engage early with the OIG, and should issue litigation holds to preserve potentially relevant information.

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