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Standards for Electronic Healthcare
Claims Attachments
I. Background
A. Summary
This proposed rule recommends the
adoption of a set of standards that will
facilitate the electronic exchange of
clinical and administrative data to
further improve the claims adjudication
process when additional documentation
(also known as health care claim
attachments) is required. This rule
proposes two X12N transaction
standards to be used—one to request the
information and one to respond to that
request with the nswers or additional
information. This rule also proposes the
use of Health Level 7 (HL7)
specifications for the content and format of communicating the actual clinical
information. And finally, this rule
proposes the adoption of the Logical
Observation Identifiers Names and
Codes, or LOINC for specific
identification of the additional
information being requested, and the
coded answers which respond to the
requests. The combination of the X12N
and HL7 standards for purposes of these
transactions is proposed because the
X12N standards are standards for
exchanging administrative information,
and the HL7 standards are standards for
exchanging clinical information; the
marriage of these standards for the
electronic health care claims attachment
transactions uses the capabilities and
advantages of each type of standard. The
LOINC code set already has the most
robust set of codes for laboratory results
and clinical reports, and now includes
the codes for the attachment
"questions" or requests proposed in this
rule.
Electronic data interchange (EDI) is
the electronic transfer of information
(such as electronic health care claims
and supplemental information) in a
standard format. EDI allows entities
within the health care system to
exchange medical, billing, and other
information to process transactions in a
more expedient and cost effective
manner. Use of EDI reduces handling
and processing time and eliminates the
risk of lost paper documents. EDI can
therefore reduce administrative
burdens, lower operating costs, and
improve overall data quality.
The health care industry already
recognizes the benefits of EDI, and there
has been a steady increase in its use
over the past decade. In fact, for many
years, health plans have been
encouraging their health care providers
to move toward electronic transmissions
of claims and inquiries, both directly
and through third parties such as health
care clearinghouses, but the transition
has been inconsistent across the board.
It is assumed that the absence of
standardization has made it difficult to
encourage widespread increases in EDI
and to develop software that could be
employed by multiple users. The Health
Insurance Portability and
Accountability Act (HIPAA) of 1996
(Pub. L. 104–191, enacted on August 21,
1996) Transaction Rule standards, with
entity type specific compliance dates in
October of either 2002 or 2003,
addressed that lack of standardization in
the health care industry. Just as
experience and process improvements
have grown with EDI, experience with
the standard transactions and
automation will result in additional efficiencies and savings for both health
care providers and health plans.
The expectation, when standard
national EDI formats and data content
for health care transactions were
adopted, was that the administrative
burdens on health plans, health care
providers, and their billing services
would decrease. A standard EDI format
allows data interchange using a
common interchange structure, thus
eliminating the need for users to
program their data processing systems
to accommodate multiple formats.
Standardization of the interchange
structure also involves specification of
which data elements are to be
exchanged; uniform definitions of those
specific data elements in each type of
electronic transaction; and
identification of the specific codes or
values that are valid for each data
element.
B. Legislation
Through subtitle F of title II of
HIPAA, the Congress added to title XI
of the Social Security Act ("the Act") a
new subpart C, entitled "Administrative
Simplification." HIPAA affects several
titles in the United States Code.
Throughout this proposed rule, we refer
to the Social Security Act as "the Act,"
and we refer to the other laws cited in
this document by their names. One
purpose of subtitle F was to improve the
efficiency and effectiveness of the
health care system in general by
encouraging the development of a more
automated health information system
through the establishment of standards
and requirements to facilitate the
electronic transmission of certain health
information. The Congress included
provisions to address the need for
supplemental health care claim
information in the form of electronic
attachments to claims.
Part C of title XI consists of sections
1171 through 1179 of the Act. These
sections define various terms and
impose requirements on the Department
of Health and Human Services (HHS),
health plans, health care clearinghouses,
and certain health care providers,
concerning the conduct of electronic
transactions, among other things.
HIPAA was discussed in greater detail
in Standards for Electronic Transactions
(65 FR 50312), published on August 17,
2000 (Transactions Rule), and the
Standards for Privacy of Individually
Identifiable Health Information (65 FR
82462), published on December 28,
2000 (Privacy Rule). Rather than
repeating the discussion here, the reader
is referred to those documents for
further information. Specific
information is provided in those documents on the content of each
section of HIPAA (for example, they
explain that section 1173 of the Act
requires the Secretary to adopt
standards for transactions and data
elements to be included in covered
transactions; section 1174 of the Act
describes the timetable for establishing
standards and for compliance with
those standards; sections 1176 and 1177
of the Act establish penalties for
violations of the established standards;
and so forth).
Two provisions of the Act are
particularly relevant to the electronic
health care claims attachment standards
being presented here:
- Section 1172 of the Act contains requirements concerning standard
setting. It states that the Secretary must
adopt a standard developed, adopted, or
modified by a standard setting
organization (that is, a standard setting
organization accredited by the American
National Standards Institute (ANSI) that
develops standards for transactions or
data elements) after consulting with the
National Uniform Billing Committee
(NUBC), the National Uniform Claim
Committee (NUCC), Workgroup for
Electronic Data Interchange (WEDI), and
the American Dental Association (ADA),
assuming there is a suitable standard.
- Section 1173(a)(2)(B) identifies a
health claim attachment [sic] as one
transaction for which electronic
standards are to be adopted.
C. Standards Setting Organizations
ANSI accredits organizations to
develop standards under the condition
that procedures used to develop and
approve the standards meet certain due
process requirements and that the
process is voluntary, open, and based on
obtaining consensus. These accredited
organizations are referred to by ANSI as
Accredited Standards Developer(s)
(ASD) or Standards Development
Organization(s)(SDO). The standards for
the transactions proposed in this rule
come from two such accredited
organizations, Accredited Standards
Committee X12 (ASC X12) and Health
Level Seven (HL7).
1. Accredited Standards Committee X12
The Accredited Standards Committee
X12 (ASC X12) is the SDO accredited by
ANSI to design national electronic
standards for a wide range of
administrative and business
applications across many industries.
ASC X12 membership is open to all
individuals and organizations. A
subcommittee of ASC X12, ASC X12N,
develops electronic standards specific to
the insurance industry, including health
care insurance. Volunteer members of the ASC X12N subcommittee, including
health care providers, health plans,
bankers, and vendors involved in
software development and billing/transmission of health care data, as well
as organizations involved in other
business aspects of health care
administrative activities, worked
together to develop standards for
electronic health care transactions.
These standards included transactions
for common administrative activities:
claims, remittance advice, claims status,
enrollment, eligibility, and
authorizations and referrals. Within
ASC X12N, Workgroup 9: Patient
Information (WG9) undertook the tasks
associated with evaluating appropriate
standards for electronic health care
claims attachments. The WG9
workgroup is comprised of
representatives from private and
government insurers, software vendors,
health care clearinghouses, State and
Federal agencies, health insurance
standards organizations, and provider
associations.
2. Health Level Seven
HL7 is a not-for-profit, ANSI accredited
SDO that provides standards
for the exchange, management, and
integration of data that support clinical
patient care and the management,
delivery, and evaluation of health care
services. While other standards
development or standard setting
organizations create standards or
protocols to meet the business needs of
a particular healthcare domain such as
pharmacy, medical devices, or
insurance, HL7"s domain is principally
clinical data. Its specific emphasis is on
the interoperability between healthcare
information systems. In fact, ""Level
Seven"" refers to the highest level of the
International Standards Organization"s
communications model for Open
Systems Interconnection—which is the
application level of a system. The
application level addresses the
definition of the data to be exchanged,
the timing of the interchange, and the
communication of certain errors to the
application. The seventh level supports
such functions as security checks,
participant identification, availability
checks, exchange mechanism
negotiations, and most significantly,
data exchange structuring. HL7 is in a
unique position to participate in
standard setting for health information
because its focus is on the interface
requirements of the entire health care
organization rather than on a particular
domain.
HL7 membership is open to all
individuals and organizations. Within
HL7, similar to Work Group 9 under X12N, the Attachments Special Interest
Group (ASIG) includes industry experts
representing health care providers,
health plans, and vendors, and is
dedicated to developing the criteria and
standards for electronic health care
claims attachments. This group created
the Additional Information
Specifications (AIS) referenced in this
proposed rule. The ASIG is responsible
for those tasks associated with creating
and maintaining the documents that
specify the content, format and codes
for submitting and responding to
requests for each type of electronic
health care claims attachment. These
documents are known as AIS, which again, are each a set of instructions and
associated code tables created and
maintained by HL7 that describes, lists,
or itemizes the additional information
that is to be sent and how such
information is to be conveyed in an
electronic health care claims
attachment.
D. Industry Standards, Implementation
Guides, and Additional Information
Specifications
1. ASC X12N and the HL7
Implementation Guides and HL7
Additional Information Specifications
ASC X12N: The ASC X12
Subcommittee N: Insurance (ASC X12N)
publishes documented specifications for
standard data interchange structures
(message transmission formats) that
apply to various business needs. For
example, the X12N 820 transaction
standard for premium payment can be
used to submit payment for automobile
insurance or casualty insurance, as well
as for health insurance. The X12N 820
was adopted as one of the standards
under HIPAA for premium payments
from an employer or group health plan
to the insurer or health plan. In order to
make these general standards functional
for industry-specific uses, it became
critical to develop implementation
specifications. These specifications,
referred to by the industry as "implementation guides," are based
upon ASC X12 standards and contain
the detailed instructions developed by
ASC X12N for using a specific
transaction to meet a specific business
need. Each ASC X12N implementation
guide has a unique version
identification number (for example,
004010, 004050, or 005010) where the
highest version number represents the
most recent version. Implementation
Guides are written collaboratively by
X12N workgroups, and are voted upon
as described below.
The ASC X12 committee is the
decision-making body responsible for obtaining consensus from the entire
organization, which is necessary before
seeking ANSI approval of a standard in
the field of health insurance. The ASC
X12N Subcommittee develops standards
and conducts maintenance activities.
The draft documents are made available
for public review and comment. After
the comments are addressed, the revised
document is presented to the entire ASC
X12N subcommittee membership group
for approval. This work is then
reviewed and approved by the
membership of ASC X12 as a whole. In
sum, Implementation Guides developed
by ASC X12N must be ratified by a
majority of voting members of the ASC
X12N subcommittee and the executive
committee of X12 itself.
HL7: To establish its standards, HL7
conducts a three-step process. First,
standards are developed and accepted
or rejected by voting at the technical
committee level. All HL7 members are
eligible to vote on standards, without
regard to whether they are members of
the committee that wrote the standard.
Non-members may also vote on a given
ballot for a standard, for which privilege
they pay an administrative fee. HL7's
policy states that it shall assess an
administrative fee for the processing,
handling, and shipping of the ballot
package. The administrative fee does
not exceed the fee associated with an
individual membership in HL7. Second,
HL7 technical committees and special
interest groups vote on "recommendations" and at least twothirds
of the total votes must be positive
for approval. Third, if approved at the
technical committee level, the
recommended standards are submitted
to the entire HL7 organization for
approval. Finally, they are submitted to
ANSI for certification.
2. Implementation Guides in HIPAA
Regulations
Section 1172(d) of the Act directs the
Secretary to establish specifications for
implementing each of the standards
adopted under this part.
For electronic transaction standards,
the SDOs developed "Implementation
Guides" for implementing the same
standards for a number of different
business purposes. For example, the
general ASC X12 claim, the 837, has
separate implementation guides that
permit its use in automobile, liability,
and health care claims. The approach
taken in the final Transactions Rule was
to adopt a specific "Implementation
Guide" as both the "standard" and the "implementation specifications" for
each health care transaction.
The regulations text of this proposed
rule also adopts the referenced guides as both the standard and the
implementation specifications for each
electronic health care claim attachment
transaction. Accordingly, this rule
proposes the adoption of specific X12
Implementation Guides (for example,
the ASC X12N 277 version 4050) as both
the standard and the implementation
specification for each transaction. To
avoid confusion in the use of certain
similar terms in this proposed rule, we
use the term "Implementation Guide"
only when referring to specific
documents published by ASC X12N.
Therefore, when we refer to the master
HL7 Implementation Guide, we will
state the full document name: "HL7
Additional Information Specification
Implementation Guide," or HL7 AIS IG.
We do not otherwise refer to "implementation specifications" or
distinguish between "standards" and "implementation specifications."
The 4050 versions of the X12
Implementation Guides are compatible
with the current X12 4010 guides
adopted for HIPAA transactions —
version 4010–1a so that the two
transactions can be used together as
necessary. In other words, a claims
transaction (837 version 4010–1a) may
be accompanied by a health care claims attachment response transaction (275
version 4050). Public comments on the
draft versions of the X12
Implementation Guides for version 4050
of the X12N 277 and X12N 275 were
solicited between December 5, 2003 and
January 9, 2004. The current guides may
be obtained from http://www.wpc-edi.com.
The other set of documents proposed
for use with electronic health care
claims attachments are called HL7
Additional Information Specifications
(AIS). These were drafted by the HL7
ASIG work group and were balloted and
approved by HL7 in September 2003.
These AIS are used in concert with the
X12 Implementation Guides and
provide the instructions for the use of
the proposed code set, to be described
later in this preamble. The adoption of
the HL7 documents would fulfill the
legal mandate for the Secretary to
establish the implementation
specifications for the HIPAA standards
proposed for adoption in accordance
with 1172(d) of the Act.
The X12N Implementation Guides,
HL7 AIS IG, HL7 AIS, and the LOINC
code set proposed for adoption in this
proposed rule, are all copyrighted by
their respective organizations, and each
document includes a copyright
statement. The copyright protection
ensures the integrity of the materials
and provides appropriate attribution to
the developers. The materials are all available at no charge. Later in this
preamble and in the regulations
themselves, we provide the mailing
addresses and Internet sites for the
documents so that readers can obtain
them in a convenient manner that will
allow for their review, along with this
proposed rule.
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