SUPPLEMENTARY INFORMATION:

I. Background

Under 45 CFR 162.940, an organization may request an exception from the use of a HIPAA standard to test a proposed modification to that standard. The purpose of the exception is to test how the proposed modification would be a significant improvement to the current standard. In its request, the requestor must explain how the proposed exception would do all the following:

• Improve the efficiency and effectiveness of the health care system by leading to cost reductions for, or improvements in benefits from, electronic health care transactions.
• Meet the needs of the health data standards user community, particularly health care providers, health plans, and health care clearinghouses.
• Be uniform and consistent with the other standards adopted under45 CFR part 162 (HIPAA Administrative Simplification) and, as appropriate, with other private and public sector health data standards.
• Have low additional development and implementation costs relative to the benefits of using the standard.
• Be supported by an ANSI-accredited SSO or other private or public organization that would maintain the standard over time.
• Have timely development, testing, implementation, and updating procedures to achieve administrative simplification benefits faster.
• Be technologically independent of the computer platforms and transmission protocols used in electronic health transactions, unless they are explicitly part of the standard.
• Be precise, unambiguous, and as simple as possible.
• Result in minimum data collection and paperwork burdens on users.
• Incorporate flexibility to adapt more easily to changes in the health care infrastructure (such as new services, organizations, and provider types) and information technology.

Additional information about the exception request and approval process can be found at: https://www.cms.gov/​files/​document/​guidance-letter-exception-process.pdf.

Inquiries regarding the exception request and approval process can be sent to: AdministrativeSimplificationException@cms.hhs.gov.

II. Exception Request

On March 10, 2021, Health Level Seven (HL7) International Da Vinci Project (Da Vinci) submitted a request for an exception from the requirements to use the HIPAA-adopted standards for referral certification and authorization (PA) transactions (X12N 278 Version 5010) and eligibility for a health plan (eligibility) transactions (X12N 270/271 Version 5010), at 45 CFR 162.1302(c) and 162.1202(c), respectively. Specifically, HL7 requested that the exception apply to Da Vinci member organizations designated as payers ^[1] and their trading partners to allow them to use the HL7 Fast Healthcare Interoperability Resources (FHIR) Prior Authorization Support (PAS) Implementation Guide (IG) in conjunction with the HL7 FHIR Coverage Requirements Discovery (CRD) IG to determine if prior authorization (PA) is required, and for performing Payer Side PA based on the FHIR standards. These alternative standards reference the use of the HL7 Documentation Templates and Rules (DTR) IG.

III. Evaluation of the Exception Request

In evaluating the request for the exception, we considered the following criteria, specified at 45 CFR 162.940(b): (1) whether the proposed modification represented a significant improvement to the current standard; (2) the extent and length of time of the exception; (3) consultations with designated standards maintenance organizations (DSMOs).

We notified HL7 that its exception request was approved on April 20, 2021, and provided details on the conditions for the approved exception, as required under 45 CFR 162.940(c)(1). The HIPAA exception allowed for Da Vinci member organizations designated as payers and their trading partners to use alternative HL7 FHIR standards to support prior authorization and eligibility transactions (for the CRD IG) without enforcement actions until April 14, 2024. The permitted alternative HL7 FHIR standards were as follows:

• HL7 FHIR PAS IG.
• HL7 FHIR CRD IG to determine if PA is required, and for performing Payer Side PA based on the FHIR standards.

The exception permitted Da Vinci to use the HL7 FHIR Prior Authorization Support (PAS) Implementation Guide (IG) and the HL7 FHIR Coverage Requirements Discovery (CRD) IG to determine if PA is required, and for performing Payer Side PA based on the FHIR standards instead of the HIPAA-adopted standards for referral certification and authorization (prior authorization) transactions (X12N 278 Version 5010) and eligibility for a health plan (eligibility) transactions (X12N 270/271 Version 5010), as required by 45 CFR 162.1302(c) and 162.1202(c), respectively.

IV. Report of Results

An organization that receives an exception under 45 CFR 162.940 must submit to the National Standards Group (NSG) a report of its results, including a cost-benefit analysis, within 90 days after completing the test.^[2] Our approval letter specified that a report of the test results must be submitted to us by July 14, 2024, which was provided on June 25, 2024. Our approval letter for the exception request and the Da Vinci test results report are available at: https://confluence.hl7.org/​display/​DVP/​Da+​Vinci+​HIPAA+​Exception.

V. Collection of Information Requirements

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office Management and Budget under the authority of the ( printed page 17828) Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

90 FR 17827