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The rulemaking implements certain provisions of the 21st Century Cures Act to establish appropriate disincentives for health care providers determined by the Inspector General to have committed information blocking. Consistent with the 21st Century Cures Act, the rulemaking establishes a first set of disincentives using HHS authorities under applicable Federal law, including authorities delegated to the Centers for Medicare & Medicaid Services, and includes related policies necessary to implement these provisions.

Statement of Need:

The rulemaking would implement a provision of the 21st Century Cures Act which requires OIG to refer health care providers that OIG determines to have committed information blocking to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking. Release of the proposed rule is needed to implement this critical component of the Cures Act and ensure effective enforcement of information blocking rules.

Summary of the Legal Basis:

The provisions would be implemented under the authority of the Public Health Service Act, as amended by the 21st Century Cures Act.

Alternatives:

ONC will consider different available authorities under which appropriate disincentives could be established to minimize regulatory burden for health care providers.

Anticipated Costs and Benefits:

The costs of this proposed rule would be minimal. Investigated parties may incur some costs in response to an OIG investigation or enforcement action by an HHS agency, however this would depend on the frequency of prohibited conduct. The expected benefits of the regulation are deterring information blocking conduct that interferes with effective health information exchange and negatively impacts many important aspects of health care, including patient access, duplicative testing and costs, and the availability and quality of care.

Risks:

We anticipate that health care providers will express concern with the potential complexity of the approach (i.e., the application of a range of disincentives based on available authorities) as compared to a range of civil monetary penalties or fines. ONC will continue to consider additional potential risks, identify them for stakeholders, and seek comment from stakeholders during the comment period for the proposed rule.