[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR162.940]

[Page 678-679]
 
                        TITLE 45--PUBLIC WELFARE
 
                    SUBTITLE A--DEPARTMENT OF HEALTH
                           AND HUMAN SERVICES
 
PART 162--ADMINISTRATIVE REQUIREMENTS--Table of Contents
 
             Subpart I--General Provisions for Transactions
 
Sec. 162.940  Exceptions from standards to permit testing of proposed modifications.

    (a) Requests for an exception. An organization may request an 
exception from the use of a standard from the Secretary to test a 
proposed modification to that standard. For each proposed modification, 
the organization must meet the following requirements:
    (1) Comparison to a current standard. Provide a detailed 
explanation, no more than 10 pages in length, of how the proposed 
modification would be a significant improvement to the current standard 
in terms of the following principles:
    (i) 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.
    (ii) Meet the needs of the health data standards user community, 
particularly health care providers, health plans, and health care 
clearinghouses.
    (iii) Be uniform and consistent with the other standards adopted 
under this part and, as appropriate, with other private and public 
sector health data standards.
    (iv) Have low additional development and implementation costs 
relative to the benefits of using the standard.

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    (v) Be supported by an ANSI-accredited SSO or other private or 
public organization that would maintain the standard over time.
    (vi) Have timely development, testing, implementation, and updating 
procedures to achieve administrative simplification benefits faster.
    (vii) Be technologically independent of the computer platforms and 
transmission protocols used in electronic health transactions, unless 
they are explicitly part of the standard.
    (viii) Be precise, unambiguous, and as simple as possible.
    (ix) Result in minimum data collection and paperwork burdens on 
users.
    (x) Incorporate flexibility to adapt more easily to changes in the 
health care infrastructure (such as new services, organizations, and 
provider types) and information technology.
    (2) Specifications for the proposed modification. Provide 
specifications for the proposed modification, including any additional 
system requirements.
    (3) Testing of the proposed modification. Provide an explanation, no 
more than 5 pages in length, 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, geographical areas, and 
beginning and ending dates of the test.
    (4) Trading partner concurrences. Provide written concurrences from 
trading partners who would agree to participate in the test.
    (b) Basis for granting an exception. The Secretary may grant an 
initial exception, for a period not to exceed 3 years, based on, but not 
limited to, the following criteria:
    (1) An assessment of whether the proposed modification demonstrates 
a significant improvement to the current standard.
    (2) The extent and length of time of the exception.
    (3) Consultations with DSMOs.
    (c) Secretary's decision on exception. The Secretary makes a 
decision and notifies the organization requesting the exception whether 
the request is granted or denied.
    (1) Exception granted. If the Secretary grants an exception, the 
notification includes the following information:
    (i) The length of time for which the exception applies.
    (ii) The trading partners and geographical areas the Secretary 
approves for testing.
    (iii) Any other conditions for approving the exception.
    (2) Exception denied. If the Secretary does not grant an exception, 
the notification explains the reasons the Secretary considers the 
proposed modification would not be a significant improvement to the 
current standard and any other rationale for the denial.
    (d) Organization's report on test results. Within 90 days after the 
test is completed, an organization that receives an exception must 
submit a report on the results of the test, including a cost-benefit 
analysis, to a location specified by the Secretary by notice in the 
Federal Register.
    (e) Extension allowed. If the report submitted in accordance with 
paragraph (d) of this section recommends a modification to the standard, 
the Secretary, on request, may grant an extension to the period granted 
for the exception.