Health Data Technology and Interoperability Final Rule Summary

On January 9, the Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services published a final rule for Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, denoted as HTI-1. Accompanying the final rule is a fact sheet that provides an overview of the policies finalized in the rule.

The American Society for Hematology (ASH) submitted comments on the proposed rule supporting changes to the standards that health IT developers must adhere to when building decision support interventions. Specifically, the Society supported the following policies which were included in the final rule:

• The allowance of a user to review source attribute information; and

• The concept that intervention risk management must also be incorporated and applied to predictive decision support interventions (DSI).

The Society also supported the following policies that are integral to health data, technology, and interoperability:

• The use of intervention risk management within health IT modules; and

• Transparency as an integral component when developing predictive models.

Predictive models may be used in various ways in healthcare including identifying patients who are at a higher risk of disease, assisting in choosing a treatment plan, and predicting likely outcomes.

Finally, CMS did publish one of the ASH comments specifically stating in the rule: “One commenter noted that they believed it is critical that ONC account for the needs of clinical guideline developers so that undue burdens are not placed on the guideline development process as DSI tools are developed and implemented in part based on clinical guidelines.” The agency stated that they took this under advisement when finalizing the rule.

Finally, the proposed rule included a request for information (RFI) on issues related to establishing certification criteria that would support complementary and interoperable workflows between physicians and pharmacies. ASH provided comments on this RFI noting that interoperability is fundamental to decreasing physician burnout and reducing administrative burden. Additional comments included:

• Information on step therapy and pricing should be readily accessible.

• Information on prior approval, if needed, should also be readily available when prescriptions are transferred to the pharmacy.

• Preferred drug classes or category of drugs should be readily available.

• Incorporating electronic prior authorization into real-time prescription benefit functionality would be beneficial to physicians and staff by reducing burden and time consuming manual prior authorizations.

The agency did not address any comments specifically but noted that all comments received will be taken into consideration in future rule-making.