On April 21, 2020, the Centers for Medical and Medicaid Services (CMS) and the Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) released for public inspection two final rules to implement the interoperability provisions of the 21st Century Cures Act of 2016 (Cures Act).
Both final rules are scheduled for publication in the May 1 Federal Register. The ONC final rule is most noteworthy for implementing key aspects of the information-blocking provision, supported by the American College of Radiology® (ACR®), among other interoperability-focused provisions from the Cures Act.
The publication date is important because the information-blocking provision in the ONC final rule is (technically) in effect six months after publication, and the scope of the program will greatly expand 24 months post-publication. As envisioned in the ONC final rule, the need to comply with the information-blocking prohibitions would theoretically begin in November 2020.
The time frame for the information-blocking provision is actually more ambiguous, however. Enforcement of the information-blocking provision does not begin until after promulgation of a future final rule from the HHS Office of Inspector General (OIG). The OIG rule-making will define civil monetary penaltiesfor certain health IT developers and health information networks/exchanges.
The OIG published a proposed rule on April 24, 2020, for a 60-day public comment period, though this rule-making is expected to take many more months to come to fruition — possibly beyond the November 2020 start date specified in the ONC May 1 final rule. Adding to the ambiguity, all disincentives/penalties for providers found in violation of the information-blocking requirements have yet to be identified. They will presumably be built into existing HHS programs, such as CMS payment programs.
Both final rules were made available for early, pre-inspection access in March 2020. The early access was timed to enable CMS and ONC representatives to publicly discuss the new rules at an eventually cancelled health IT conference. A consolidated overview of the CMS and ONC final rules was published in the March 12, 2020, ACR Advocacy in Action.