Notice2025-07386
Notification Regarding the Use of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Administrative Simplification Standards Exceptions Process by the Health Level Seven (HL7) International Da Vinci Project (Da Vinci) and the Availability of the Da Vinci Report
Primary source
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Published
April 29, 2025
Issuing agencies
Health and Human Services Department
Abstract
This notice provides the public with information about the availability and location of the Health Level Seven (HL7) International Da Vinci Project (Da Vinci) Report, which includes test results from the use of alternative standards for Referral Certification and Authorization and Eligibility for Health Plan transactions approved under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) exceptions process.
Full Text
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<title>Federal Register, Volume 90 Issue 81 (Tuesday, April 29, 2025)</title>
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[Federal Register Volume 90, Number 81 (Tuesday, April 29, 2025)]
[Notices]
[Pages 17827-17828]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07386]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[CMS-0034-N]
Notification Regarding the Use of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Administrative
Simplification Standards Exceptions Process by the Health Level Seven
(HL7) International Da Vinci Project (Da Vinci) and the Availability of
the Da Vinci Report
AGENCY: Office of the Secretary, Department of Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: This notice provides the public with information about the
availability and location of the Health Level Seven (HL7) International
Da Vinci Project (Da Vinci) Report, which includes test results from
the use of alternative standards for Referral Certification and
Authorization and Eligibility for Health Plan transactions approved
under the Health Insurance Portability and Accountability Act of 1996
(HIPAA) exceptions process.
FOR FURTHER INFORMATION CONTACT: Michael Cimmino (410) 786-6408.
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:
<bullet> 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.
<bullet> Meet the needs of the health data standards user
community, particularly health care providers, health plans, and health
care clearinghouses.
<bullet> Be uniform and consistent with the other standards adopted
under 45 CFR part 162 (HIPAA Administrative Simplification) and, as
appropriate, with other private and public sector health data
standards.
<bullet> Have low additional development and implementation costs
relative to the benefits of using the standard.
<bullet> Be supported by an ANSI-accredited SSO or other private or
public organization that would maintain the standard over time.
<bullet> Have timely development, testing, implementation, and
updating procedures to achieve administrative simplification benefits
faster.
<bullet> Be technologically independent of the computer platforms
and transmission protocols used in electronic health transactions,
unless they are explicitly part of the standard.
<bullet> Be precise, unambiguous, and as simple as possible.
<bullet> Result in minimum data collection and paperwork burdens on
users.
<bullet> 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: <a href="https://www.cms.gov/files/document/guidance-letter-exception-process.pdf">https://www.cms.gov/files/document/guidance-letter-exception-process.pdf</a>.
Inquiries regarding the exception request and approval process can
be sent to: <a href="/cdn-cgi/l/email-protection#4f0e2b222621263c3b3d2e3b26392a1c26223f232629262c2e3b2620210a372c2a3f3b2620210f2c223c6127273c61282039"><span class="__cf_email__" data-cfemail="2d6c49404443445e595f4c59445b487e44405d41444b444e4c5944424368554e485d594442436d4e405e0345455e034a425b">[email protected]</span></a>.
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.
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\1\ <a href="https://confluence.hl7.org/display/DVP/Da+Vinci+Project+Members">https://confluence.hl7.org/display/DVP/Da+Vinci+Project+Members</a>.
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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:
<bullet> HL7 FHIR PAS IG.
<bullet> 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: <a href="https://confluence.hl7.org/display/DVP/Da+Vinci+HIPAA+Exception">https://confluence.hl7.org/display/DVP/Da+Vinci+HIPAA+Exception</a>.
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\2\ See <a href="https://www.cms.gov/files/document/guidance-letter-exception-process.pdf">https://www.cms.gov/files/document/guidance-letter-exception-process.pdf</a>.
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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
[[Page 17828]]
Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-07386 Filed 4-25-25; 4:15 pm]
BILLING CODE 4120-01-P
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