Standards and Implementation Guides

Standards and Implementation Guides

What resources are available for additional assistance with technical questions related to the suggested implementation guides (IGs)?

CMS encouraged the use of certain Health Level 7® (HL7) Fast Healthcare Interoperability Resources® (FHIR) Implementation Guides, and provided links to information and resources on our website. There are a number of implementer work groups in which impacted payers and their vendors may be interested in participating to support their project development and implementation plans. Technical questions may be addressed from these resources through the main HL7® Zulip chat stream (https://chat.fhir.org/) or to one of the HL7® Zulip chat links below based on the relevant IG.

Are there certification criteria under the ONC Health IT Certification Program that support the function of electronic prior authorization? Are there testing tools for payers to test their implementation of the APIs required in the CMS Interoperability and Prior Authorization final rule (CMS-0057-F)?

At this time, there are not Certified Health IT criteria for EHRs that support electronic prior authorization. However, the ONC Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule has proposed to adopt a set of certification criteria to support data exchange – including those about prior authorization – between payers, providers, and patients. See the full HTI-2 proposed rule here and a fact sheet about this proposal here.

The ONC-developed Inferno tool is available to test Fast Healthcare Interoperability Resources® (FHIR®) application programming interfaces (APIs) for conformance with certain implementation guides (IGs) developed by the HL7® Da Vinci Project and the CARIN Alliance, which are recommended in the CMS Interoperability and Prior Authorization final rule (CMS-0057-F). Inferno can test accessing payer drug formulary information as defined in the HL7® Da Vinci Payer Data Exchange (PDEX) US Drug Formulary IG (v2.0.1), accessing payer insurance plan network directory information as defined in the HL7® Da Vinci PDEX Plan Net IG (v1.1.0), and consumer access to their digital health information from a payer via a third-party application as defined in the HL7® CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button®) IG (v1.1.0, v2.0.0).

Additionally, the DaVinci Prior Authorization Support (PAS) Test Kit provides developers and other health IT implementers with a tool to test health IT systems support for prior authorization.

This test kit focuses on prior authorization support according to the PAS Implementation Guide version 2.0.1 and includes tests for clients (e.g., electronic health record systems) and servers (e.g., payer systems). Tests for these systems include verifying support for required FHIR® operations and profiles from the PAS IG. The open source DaVinci PAS Test Kit is available for download on GitHub alongside other health IT test kits designed using the Inferno FHIR® testing framework.

May payers use an updated version of the standards required in the CMS Interoperability and Prior Authorization final rule (CMS-0057-F)?

Yes, the CMS Interoperability and Prior Authorization final rule (CMS-0057-F) allows impacted payers to use updated versions of the required standards under the following conditions: the updated version of the standard is required by other applicable law; or (1) the updated version of the standard is not prohibited under other applicable law, (2) the National Coordinator has approved the updated version for use in the ONC Health IT Certification Program, and (3) the updated version does not disrupt an end user’s ability to access the data required to be available through the API. For the updated versions listed at 45 CFR 170.215, such as the US Core Implementation Guide (IG) v6.1.0 and the SMART App Launch IG v2.0.0, the first criterion has been met. Additionally, CMS is exploring rulemaking to align with the updated versions finalized at 45 CFR 170.215 prior to the application programming interface (API) compliance dates.

The final rule also requires impacted payers to use a version of the United States Core Data for Interoperability (USCDI) listed at 45 CFR 170.213. In January 2024, the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule (89 FR 1192) appeared in the Federal Register, which established two available versions of USCDI—Version 1 (v1, July 2020 Errata) at 45 CFR 170.213(a) and USCDI v3 at 45 CFR 170.213(b). USCDI v1 will expire on January 1, 2026. When multiple versions of USCDI are adopted at 45 CFR 170.213, payers may use any active version of that standard. As ONC adopts new versions of the USCDI at 45 CFR 170.213, they will become available for payers to use in their APIs. As versions of the USCDI expire at that citation, they will no longer be available for impacted payers to use.

For inquiries regarding standards requirements as specified in ONC rules, please contact ONC via email at onc.request@hhs.gov or complete the applicable form found on ONC’s Contact Us page.

Are the recommended implementation guides (IGs) listed in Table H3 of the CMS Interoperability and Prior Authorization final rule required to be used?

No, the recommended IGs listed in table H3 are not required to be used at this time. However, we do strongly encourage implementers to use the recommended IGs. Based on the maturity at the time of rulemaking, CMS believes the approach of recommending, but not requiring, specific versions of the recommended IGs provides necessary directional guidance without locking implementers into the versions of the IGs available at the time the CMS Interoperability and Prior Authorization final rule (CMS-0057-F) was published. Furthermore, this approach allows the IG authors and community to receive feedback from real-world use and to further mature and refine the IGs. CMS may consider requiring certain mature IGs through future rulemaking. 

Footnotes

Page Last Modified:
08/01/2024 08:51 PM
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