New Federal Interoperability Final Rules
In our second coalition meeting of 2024, we delved into recent federal health care regulations, specifically focusing on the Health Data Technology and Interoperability Final Rule, effective February 8, 2024.
The key components of the rule include:
- Algorithm transparency requirements for Artificial Intelligence (AI) and predictive analytics
- Adoption of USCDI Version 3 as the baseline standard for ONC-certified health IT by 2025
- Updates to information blocking regulations by revising exception conditions and definitions
- Establishes TEFCA Manner Exception to encourage participation in the national framework
- Defines interoperability-focused reporting metrics for most developers of ONC-certified health IT
The establishment of the TEFCA Manner Exception under the Act’s information blocking exceptions is a notable update to ONC’s information blocking exceptions previously defined in the 21st Century Cures Act. The exception applies when both the information requestor and the actor are participants of TEFCA, and the request is not via API standards (such as Fast Healthcare Interoperability Resources or FHIR-based standards). Additionally, any necessary fees and licensing terms must comply with the Fees Exception and the Licensing Exception respectively.
We also discussed the AI transparency components of the rule. A notable change from the initially proposed rule is the narrowed scope of developer responsibilities under this certification, limited to interventions supplied as part of a product package offered to clients. This change, effective from January 1, 2025, under the Health IT certification program, contrasts with the broader definition in the initial proposal, which included interventions enabled or interfaced with.
Andrea Frey from Hooper, Lundy & Bookman, commended the ONC for the groundbreaking updates focusing on transparency and on narrowing the applicability of the decision support intervention criteria for developers of certified Health IT. Jen DeAngelis from Blue Shield of California offered a payer perspective on the significant impact of the rule, including the update to USCDI v3, which has a significant impact on health plans. She sees the transparency requirements in recent proposals as an opening move by HHS to regulate AI and predictive algorithms.
We then moved onto the recently finalized CMS Interoperability and Prior Authorization Rule, with various components related to API development set to take effect in 2026 and 2027. The rule aims to enhance transparency and efficiency in prior authorization processes for Medicare and Medicaid plans. It mandates payers to implement an HL7 FHIR patient access API, a provider access API for data sharing within network providers, a payer-payer API to ensure continuity of care during plan or payer changes, and a prior authorization API to convey approvals, denials, and reasons for decisions or requests for more information. Notably, starting in 2026, prior authorization decisions must be transmitted within 72 hours for expedited requests and within seven days for standard requests.
Connecting for Better Health remains attentive to guidance from ONC and CMS as we seek opportunities to align with and build upon federal efforts as California’s Data Exchange Framework and other statewide transformation initiatives are being implemented.
