Exceptions Process

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Exceptions Process Overview

An organization may request an exception from the use of a standard transaction from the Secretary to test a proposed modification to that standard (in accordance with 45 Code of Federal Regulations (C.F.R.) § 162.940).

The purpose is to test whether the modification improves the efficiency and effectiveness of the health care system by leading to cost reductions or improvements in benefits from electronic transactions.

Exception Requests Must Include Four Artifacts

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1. Exception Request Proposal

The Exception Request Proposal should provide a comparison of the proposed standard to the current adopted standard that includes an explanation (no more than 10 pages) of how the proposed modification would be a significant improvement to the current adopted standard in terms of the 10 guiding principles.

Learn more about the 10 principles for requesting an exception (PDF).

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2. Specifications of the Proposed Modification

The Exception Request must include specifications for the proposed modification that includes any additional system requirements.

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3. Testing Proposal

The Exception Request must include an explanation of how the organization intends to test the standard, including the number and types of health plans and health care providers expected to be involved in the test, the geographic areas affected, and the beginning and ending dates of the testing (no more than five pages).

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4. Trading Partner Concurrences

The Requesting Organization must provide written concurrences from trading partners who would agree to participate in the test.

Learn More

Additional instructions may be found in this Guidance Letter (PDF) on the CMS website.

To submit your exception request or if you have questions about this guidance, send inquiries to AdministrativeSimplificationException@cms.hhs.gov with the subject line: HIPAA Transaction Exception Question.

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Page Last Modified:
12/18/2024 08:04 PM