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Standards for Electronic Healthcare
Claims Attachments
III. Modifications to Standards and
New Electronic Attachments
[If you choose to comment on issues
in this section, please include the
caption "MODIFICATIONS TO
STANDARDS AND NEW
ATTACHMENTS" at the beginning of
your comments.]
To encourage innovation and promote
development, we propose to adopt a
process that will facilitate the
development and future use of
electronic health care claims
attachments. In 1993, WEDI estimated
that 400 or more specific attachments
were in use to support health care
business needs. Comments from the
industry are needed to validate and/or
update this figure, as it is over 10 years
old, and represents many different types
of attachments which are not all
required solely for health care claims
adjudication. For example, the original
list of attachments included such
documentation types as certification for
sterilization and hysterectomy, dental
services, eligibility, worker’s
compensation verification and the like.
We do not believe that there are 400
different health care claims attachment
types that would in fact be appropriate
for electronic health care claims
attachment requirements. The industry
should identify the relevant attachment
types and collaborate to assign priority
to each one, so that new electronic
attachment specifications that are
appropriate to the business needs of the
health care industry can be developed.
A. Modifications to Standards
In §162.910, parameters are outlined
for requesting and making modifications
to the standards. The statute provides
that the Secretary of HHS may not
modify any standard, including the
electronic attachment standards, more
frequently than once a year and must
permit at least 180 days for
implementation of an adopted
modification to a standard by all
affected entities before compliance with
the modified standard may be required.
The Secretary may, however, adopt a
modification at any time during the first
year after the standard or
implementation specification is initially
adopted, if the Secretary determines that
the modification is necessary to permit
compliance with the standard.
The addition or deletion of codes in
a code set for the purpose of enhancing
the electronic attachment's
communication capabilities is
considered maintenance, because such
actions do not constitute format or field
length changes to the codes or the code
set itself. HIPAA expressly permits the
routine maintenance, testing,
enhancements, and expansion of a code
set. We have stated throughout the
preamble, that if the codes or code set
were changed structurally—for example,
changing from a numeric format to an
alphanumeric format, this would be
considered an actual modification of the
code set that would require system
changes. Use of such a modified code
set could not be required, and would
not be permitted, without a regulatory
change.
There are mechanisms in place for
LOINC to add new codes on a regular
basis to reflect developments in the
industry, just as occurs with ICD–9,
CPT–4, and HCPCS, among others. New
codes may be used in an electronic
health care claims attachment without a
change to the rule, if use of a new code
is specifically permitted by the AIS, and
the use complies with the associated
ASC X12N Implementation Guides and
HL7 AISs. For example, new LOINC
codes for new types of laboratory results
and clinical reports will be added to
LOINC based on medical
developments. Use of such new codes is
permitted by the AIS for laboratory
results, clinical reports and medications
in both the request and the response
transactions.
Requests for new LOINC codes are to
be addressed to the Regenstrief Institute
for Health Care, c/o LOINC Committee,
1050 West Wishard Blvd., Indianapolis,
IN 46202, or electronically, in
accordance with the instructions in
Appendix D of the LOINC users guide,
to the Regenstrief Web site at http://www.regenstrief.org and will be
evaluated through the existing process.
Once a HIPAA standard is adopted in
a final rule, requests for changes to that
standard must be submitted through the
DSMO process, as set forth in §162.910(c). After approval, the DSMOs
will forward proposed new
implementation specifications to the
NCVHS and to the Secretary. The
NCVHS serves as a consultative body
that, under the provisions of the Public
Health Service Act, provides advice
concerning specified health care matters
to the Secretary. Following consultation
with appropriate agencies and
organizations, including the NCVHS,
the Secretary may adopt the modified
versions as HIPAA standards through
the notice and comment rulemaking
process.
Information pertaining to the
designation of DSMOs and their
responsibilities can be found in the
Transactions Rule and the notice
announcing the DSMOs, which were
published on August 17, 2000 (65 FR
50365, 50373).
B. Additional Information
Specifications for New Electronic
Attachments
We expect that the HL7 ASIG will
continue to develop new standard AISs
using the HL7 CDA Release 1.0
framework, and these will be approved
under the established DSMO process.
After development and approval by the
DSMO, new AISs will be sent to the
NCVHS and then to the Secretary for
consideration. Upon receipt of new
proposed additional information
specifications, the Secretary may choose
to incorporate them in a future proposed
rule and subsequently may adopt them
as HIPAA standards.
C. Use of Proposed and New Electronic
Attachment Types Before Formal
Approval and Adoption
Due to the need to complete this
rulemaking, together with the delayed
compliance dates provided for by
statute, the final rule will not be
implemented for several years. There
are no Federal prohibitions on the use
of the proposed X12 standard
transactions or HL7 AIS between now
and the time compliance with the final
standards is required. Even after the
final rule is published, and compliance
is required, if the Secretary has not
named a standard for a particular type
of electronic claims attachment, covered
entities are still free to use that
attachment type on a voluntary basis for
any business purpose they deem
appropriate.
For example, if the DME attachment
specification is finalized, balloted, and
approved by HL7 after publication of
the final rule, but DME is not one of the
named attachment types, covered
entities will be able to use that AIS and
the X12N 277/275 implementation
guides with no regulatory requirements.
In other words, use of a new AIS that
has not been formally adopted, as a
standard by the Secretary, would be
voluntary, based on trading partner
agreements or other such contracts,
unless and until regulations adopting
that AIS are proposed and made final
through the regulatory process.
IV. Collection of Information Requirements
The burden associated with the requirements in this regulation are the time and effort of health plans, health care providers and/or health care clearinghouses to modify their systems for the capability of sending health care transactions electronically. This onetime burden has already been approved and accounted for in "HIPAA Standards for Coding Electronic Transactions" (OMB #0938–0866) with a current expiration date of February 29, 2008. However, we will amend this currently approved collection to include electronic health claims attachments to the list of covered transactions.
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