Proposed Rule: Medicare and Medicaid: Health Insurance Portability and Accountability Act Implementation&#8212 Electronic Health Care Claims Attachments Standards

Friday,
September 23, 2005
Part III
Department of
Health and Human
Services
Office of the Secretary
45 CFR Part 162

HIPAA Administrative Simplification:
Standards for Electronic Health Care
Claims Attachments; Proposed Rule
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55990 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Proposed Rules
DEPARTMENT OF HEALTH AND comment period to one of the addresses 1. Accredited Standards Committee X12
HUMAN SERVICES above or below. If you intend to deliver (ASC X12)
your comments to the Baltimore 2. Health Level Seven (HL7)
Office of the Secretary D. Industry Standards, Implementation
address, please call (410) 786–7195 in Guides and Additional Information
advance to schedule your arrival with Specifications
45 CFR Part 162 one of our staff members. 1. ASC X12N and the HL7 Implementation
[CMS–0050–P] Hubert H. Humphrey Building, Room Guides and HL7 Additional Information
445–G 200 Independence Avenue, SW., Specifications
RIN 0938–AK62 Washington, DC 20201; or 7500 Security 2. Implementation Guides in HIPAA
Boulevard, Baltimore, MD 21244–1850. Regulations
HIPAA Administrative Simplification: II. Provisions of the Proposed Regulations
Standards for Electronic Health Care (Because access to the interior of the A. Definitions
Claims Attachments HHH Building is not readily available to 1. Ambulance Services
persons without Federal Government 2. Attachment Information
AGENCY: Office of the Secretary, HHS. identification, commenters are 3. Clinical Reports
ACTION: Proposed rule. encouraged to leave their comments in 4. Emergency Department
the CMS drop slots located in the main 5. Laboratory Results
SUMMARY: This rule proposes standards 6. Logical Observation Identifiers Names
lobby of the building. A stamp-in clock
and Codes (LOINC))
for electronically requesting and is available for persons wishing to retain 7. Medications
supplying particular types of additional a proof of filing by stamping in and 8. Rehabilitation Services
health care information in the form of retaining an extra copy of the comments B. Effective Dates
an electronic attachment to support being filed.) C. Overview of Key Information for
submitted health care claims data. It Comments mailed to the addresses Electronic Health Care Claims
would implement some of the indicated as appropriate for hand or Attachments
requirements of the Administrative 1. Overview of Extensible Markup
courier delivery may be delayed and Language (XML)
Simplification subtitle of the Health received after the comment period. 2. Overview of Clinical Document
Insurance Portability and For information on viewing public Architecture
Accountability Act of 1996. comments, see the beginning of the 3. How XML Is Applied Within the
DATES: To be assured consideration, SUPPLEMENTARY INFORMATION section. Clinical Document Architecture
comments must be received at one of 4. Transactions for Transmitting Electronic
FOR FURTHER INFORMATION CONTACT:
the addresses provided below, no later Attachments
Lorraine Tunis Doo, (410) 786–6597. 5. Electronic Claims Attachment Types
than 5 p.m. on November 22, 2005.
SUPPLEMENTARY INFORMATION: 6. Format Options (Human vs. Computer
ADDRESSES: In commenting, please refer Variants) for Electronic Claims
Submitting Comments: We welcome
to file code CMS–0050–P. Because of Attachments
comments from the public on all issues
staff and resource limitations, we cannot 7. Combined Use of Two Different
set forth in this proposed rule to assist Standards Through Standard
accept comments by facsimile (FAX)
us in fully considering issues and Development Organization (SDO)
transmission.
developing policies. You can assist us Collaboration
You may submit comments in one of
by referencing the file code [CMS–0050– D. Electronic Health Care Claims
four ways (no duplicates, please):
P] and the specific ‘‘issue identifier’’ Attachment Business Use
1. Electronically. You may submit 1. Electronic Health Care Claims
that precedes the section on which you
electronic comments on specific issues Attachment vs. Health Care Claims Data
choose to comment.
in this regulation to http:// 2. Solicited vs. Unsolicited Electronic
www.cms.hhs.gov/regulations/ Inspection of Public Comments: All
Health Care Claims Attachments
ecomments. Attachments should be in comments received before the close of 3. Coordination of Benefits
Microsoft Word, WordPerfect, or Excel; the comment period are available for 4. Impact of Privacy Rule
however, we prefer Microsoft Word. viewing by the public, including any 5. Impact of the Security Rule
2. By mail. You may mail written personally identifiable or confidential 6. Connection to Signatures (Hard Copy
comments (one original and two copies) business information that is included in and Electronic)
a comment. CMS posts all comments 7. Connection to Consolidated Health
to the following address ONLY: Informatics Initiative
Centers for Medicare & Medicaid received before the close of the
comment period on its public Web site 8. Health Care Provider vs. Health Plan
Services, Department of Health and Perspective
Human Services, Attention: CMS–0050– as soon as possible after they have been 9. Health Care Clearinghouse Perspective
P, P.O. Box 8014, Baltimore, MD 21244– received. Comments received timely E. Electronic Health Care Claims
8014. will be available for public inspection as Attachment Content and Structure
Please allow sufficient time for mailed they are received, generally beginning F. Alternatives Considered: Candidate
comments to be received before the approximately 3 weeks after publication Standards for Transaction Types and
of a document, at the headquarters of Code Sets
close of the comment period. 1. Transactions
3. By express or overnight mail. You the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, a. Health Care Claims Attachment Request
may send written comments (one Transaction
original and two copies) to the following Baltimore, Maryland 21244–1850, b. Health Care Claims Attachment
address ONLY: Centers for Medicare & Monday through Friday of each week Response Transaction
Medicaid Services, Department of from 8:30 a.m. to 4 p.m. To schedule an 2. Code Sets
Health and Human Services, Attention: appointment to view public comments, 3. Implementation Specifications for
CMS–0050–P, Mail Stop C4–26–05, phone 1–800–743–3951. Sending and Receiving Additional
Health Care Information within a
Baltimore, MD 21244–1850. Table of Contents Transaction
4. By hand or courier. If you prefer, I. Background G. Proposed Standards
you may deliver (by hand or courier) A. Summary 1. Code Set
your written comments (one original B. Legislation 2. Electronic Health Care Claims
and two copies) before the close of the C. Standards Setting Organizations Attachment Request Transaction
Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Proposed Rules 55991
3. Electronic Health Care Claims of communicating the actual clinical efficiencies and savings for both health
Attachment Response Transaction information. And finally, this rule care providers and health plans.
4. Examples of How Electronic Health Care proposes the adoption of the Logical The expectation, when standard
Claims Attachments Could Be national EDI formats and data content
Observation Identifiers Names and
Implemented
a. Use of the Proposed Transactions Codes, or LOINC for specific for health care transactions were
Specifications, and Codes for Electronic identification of the additional adopted, was that the administrative
Health Care Claims Attachments information being requested, and the burdens on health plans, health care
b. White Paper from HL7 coded answers which respond to the providers, and their billing services
H. Requirements (Health Plans, Covered requests. The combination of the X12N would decrease. A standard EDI format
Health Care Providers and Health Care and HL7 standards for purposes of these allows data interchange using a
Clearinghouses) transactions is proposed because the common interchange structure, thus
1. Additional Information Specification eliminating the need for users to
X12N standards are standards for
(AIS) Uses: Attachment Types That May program their data processing systems
Be Used for Any Service exchanging administrative information,
and the HL7 standards are standards for to accommodate multiple formats.
a. Clinical Reports
b. Laboratory Results exchanging clinical information; the Standardization of the interchange
c. Medications marriage of these standards for the structure also involves specification of
2. Additional Information Specification electronic health care claims attachment which data elements are to be
(AIS) Uses: Attachment Types for transactions uses the capabilities and exchanged; uniform definitions of those
Specific Services advantages of each type of standard. The specific data elements in each type of
a. Rehabilitation Services electronic transaction; and
LOINC code set already has the most
b. Ambulance Service identification of the specific codes or
c. Emergency Department robust set of codes for laboratory results
and clinical reports, and now includes values that are valid for each data
3. Maximum Data Set
I. Specific Documents and Sources the codes for the attachment element.
III. Modifications to Standards and New ‘‘questions’’ or requests proposed in this B. Legislation
Electronic Attachments rule.
A. Modifications to Standards Through subtitle F of title II of
Electronic data interchange (EDI) is HIPAA, the Congress added to title XI
B. Additional Information Specifications the electronic transfer of information
for New Electronic Attachments of the Social Security Act (‘‘the Act’’) a
C. Use of Proposed and New Electronic (such as electronic health care claims new subpart C, entitled ‘‘Administrative
Attachment Types Before Formal and supplemental information) in a Simplification.’’ HIPAA affects several
Approval and Adoption standard format. EDI allows entities titles in the United States Code.
IV. Collection of Information Requirements within the health care system to Throughout this proposed rule, we refer
V. Response to Comments exchange medical, billing, and other to the Social Security Act as ‘‘the Act,’’
VI. Regulatory Impact Analysis information to process transactions in a
A. Overall Impact
and we refer to the other laws cited in
more expedient and cost effective this document by their names. One
1. Affected Entities (Covered Entities) manner. Use of EDI reduces handling
2. Effects of Various Options purpose of subtitle F was to improve the
B. Cost and Benefit Analysis
and processing time and eliminates the efficiency and effectiveness of the
1. General Assumptions, Limitations, and risk of lost paper documents. EDI can health care system in general by
Scope therefore reduce administrative encouraging the development of a more
2. Cost and Benefit Analysis for Health burdens, lower operating costs, and automated health information system
Plans improve overall data quality. through the establishment of standards
3. Cost and Benefit Analysis for Health The health care industry already and requirements to facilitate the
Care Providers recognizes the benefits of EDI, and there
4. Cost and Benefit Estimates electronic transmission of certain health
a. Costs of Implementation
has been a steady increase in its use information. The Congress included
b. Benefits of Implementation over the past decade. In fact, for many provisions to address the need for
5. Conclusions years, health plans have been supplemental health care claim
C. Guiding Principles for Standard encouraging their health care providers information in the form of electronic
Selection to move toward electronic transmissions attachments to claims.
1. Overview of claims and inquiries, both directly Part C of title XI consists of sections
2. General and through third parties such as health 1171 through 1179 of the Act. These
Regulations Text care clearinghouses, but the transition sections define various terms and
I. Background has been inconsistent across the board. impose requirements on the Department
It is assumed that the absence of of Health and Human Services (HHS),
A. Summary standardization has made it difficult to health plans, health care clearinghouses,
This proposed rule recommends the encourage widespread increases in EDI and certain health care providers,
adoption of a set of standards that will and to develop software that could be concerning the conduct of electronic
facilitate the electronic exchange of employed by multiple users. The Health transactions, among other things.
clinical and administrative data to Insurance Portability and HIPAA was discussed in greater detail
further improve the claims adjudication Accountability Act (HIPAA) of 1996 in Standards for Electronic Transactions
process when additional documentation (Pub. L. 104–191, enacted on August 21, (65 FR 50312), published on August 17,
(also known as health care claim 1996) Transaction Rule standards, with 2000 (Transactions Rule), and the
attachments) is required. This rule entity type specific compliance dates in Standards for Privacy of Individually
proposes two X12N transaction October of either 2002 or 2003, Identifiable Health Information (65 FR
standards to be used—one to request the addressed that lack of standardization in 82462), published on December 28,
information and one to respond to that the health care industry. Just as 2000 (Privacy Rule). Rather than
request with the answers or additional experience and process improvements repeating the discussion here, the reader
information. This rule also proposes the have grown with EDI, experience with is referred to those documents for
use of Health Level 7 (HL7) the standard transactions and further information. Specific
specifications for the content and format automation will result in additional information is provided in those
documents on the content of each the ASC X12N subcommittee, including X12N, the Attachments Special Interest
section of HIPAA (for example, they health care providers, health plans, Group (ASIG) includes industry experts
explain that section 1173 of the Act bankers, and vendors involved in representing health care providers,
requires the Secretary to adopt software development and billing/ health plans, and vendors, and is
standards for transactions and data transmission of health care data, as well dedicated to developing the criteria and
elements to be included in covered as organizations involved in other standards for electronic health care
transactions; section 1174 of the Act business aspects of health care claims attachments. This group created
describes the timetable for establishing administrative activities, worked the Additional Information
standards and for compliance with together to develop standards for Specifications (AIS) referenced in this
those standards; sections 1176 and 1177 electronic health care transactions. proposed rule. The ASIG is responsible
of the Act establish penalties for These standards included transactions for those tasks associated with creating
violations of the established standards; for common administrative activities: and maintaining the documents that
and so forth). claims, remittance advice, claims status, specify the content, format and codes
Two provisions of the Act are enrollment, eligibility, and for submitting and responding to
particularly relevant to the electronic authorizations and referrals. Within requests for each type of electronic
health care claims attachment standards ASC X12N, Workgroup 9: Patient health care claims attachment. These
being presented here: Information (WG9) undertook the tasks documents are known as AIS, which
• Section 1172 of the Act contains associated with evaluating appropriate again, are each a set of instructions and
requirements concerning standard standards for electronic health care associated code tables created and
setting. It states that the Secretary must claims attachments. The WG9 maintained by HL7 that describes, lists,
adopt a standard developed, adopted, or workgroup is comprised of or itemizes the additional information
modified by a standard setting representatives from private and that is to be sent and how such
organization (that is, a standard setting government insurers, software vendors, information is to be conveyed in an
organization accredited by the American health care clearinghouses, State and electronic health care claims
National Standards Institute (ANSI) that Federal agencies, health insurance attachment.
develops standards for transactions or standards organizations, and provider
data elements) after consulting with the associations. D. Industry Standards, Implementation
National Uniform Billing Committee Guides, and Additional Information
2. Health Level Seven Specifications
(NUBC), the National Uniform Claim
Committee (NUCC), Workgroup for HL7 is a not-for-profit, ANSI- 1. ASC X12N and the HL7
Electronic Data Interchange (WEDI), and accredited SDO that provides standards Implementation Guides and HL7
the American Dental Association (ADA), for the exchange, management, and Additional Information Specifications
assuming there is a suitable standard. integration of data that support clinical
• Section 1173(a)(2)(B) identifies a patient care and the management, ASC X12N: The ASC X12
health claim attachment [sic] as one delivery, and evaluation of health care Subcommittee N: Insurance (ASC X12N)
transaction for which electronic services. While other standards publishes documented specifications for
standards are to be adopted. development or standard setting standard data interchange structures
organizations create standards or (message transmission formats) that
C. Standards Setting Organizations protocols to meet the business needs of apply to various business needs. For
ANSI accredits organizations to a particular healthcare domain such as example, the X12N 820 transaction
develop standards under the condition pharmacy, medical devices, or standard for premium payment can be
that procedures used to develop and insurance, HL7’s domain is principally used to submit payment for automobile
approve the standards meet certain due clinical data. Its specific emphasis is on insurance or casualty insurance, as well
process requirements and that the the interoperability between healthcare as for health insurance. The X12N 820
process is voluntary, open, and based on information systems. In fact, ‘‘Level was adopted as one of the standards
obtaining consensus. These accredited Seven’’ refers to the highest level of the under HIPAA for premium payments
organizations are referred to by ANSI as International Standards Organization’s from an employer or group health plan
Accredited Standards Developer(s) communications model for Open to the insurer or health plan. In order to
(ASD) or Standards Development Systems Interconnection—which is the make these general standards functional
Organization(s)(SDO). The standards for application level of a system. The for industry-specific uses, it became
the transactions proposed in this rule application level addresses the critical to develop implementation
come from two such accredited definition of the data to be exchanged, specifications. These specifications,
organizations, Accredited Standards the timing of the interchange, and the referred to by the industry as
Committee X12 (ASC X12) and Health communication of certain errors to the ‘‘implementation guides,’’ are based
Level Seven (HL7). application. The seventh level supports upon ASC X12 standards and contain
such functions as security checks, the detailed instructions developed by
1. Accredited Standards Committee X12 participant identification, availability ASC X12N for using a specific
The Accredited Standards Committee checks, exchange mechanism transaction to meet a specific business
X12 (ASC X12) is the SDO accredited by negotiations, and most significantly, need. Each ASC X12N implementation
ANSI to design national electronic data exchange structuring. HL7 is in a guide has a unique version
standards for a wide range of unique position to participate in identification number (for example,
administrative and business standard setting for health information 004010, 004050, or 005010) where the
applications across many industries. because its focus is on the interface highest version number represents the
ASC X12 membership is open to all requirements of the entire health care most recent version. Implementation
individuals and organizations. A organization rather than on a particular Guides are written collaboratively by
subcommittee of ASC X12, ASC X12N, domain. X12N workgroups, and are voted upon
develops electronic standards specific to HL7 membership is open to all as described below.
the insurance industry, including health individuals and organizations. Within The ASC X12 committee is the
care insurance. Volunteer members of HL7, similar to Work Group 9 under decision-making body responsible for
obtaining consensus from the entire both the standard and the available at no charge. Later in this
organization, which is necessary before implementation specifications for each preamble and in the regulations
seeking ANSI approval of a standard in electronic health care claim attachment themselves, we provide the mailing
the field of health insurance. The ASC transaction. Accordingly, this rule addresses and Internet sites for the
X12N Subcommittee develops standards proposes the adoption of specific X12 documents so that readers can obtain
and conducts maintenance activities. Implementation Guides (for example, them in a convenient manner that will
The draft documents are made available the ASC X12N 277 version 4050) as both allow for their review, along with this
for public review and comment. After the standard and the implementation proposed rule.
the comments are addressed, the revised specification for each transaction. To
II. Provisions of the Proposed
document is presented to the entire ASC avoid confusion in the use of certain
Regulations
X12N subcommittee membership group similar terms in this proposed rule, we
for approval. This work is then use the term ‘‘Implementation Guide’’ This proposed rule describes
reviewed and approved by the only when referring to specific requirements that health plans, covered
membership of ASC X12 as a whole. In documents published by ASC X12N. health care providers, and health care
sum, Implementation Guides developed Therefore, when we refer to the master clearinghouses would have to meet to
by ASC X12N must be ratified by a HL7 Implementation Guide, we will comply with the statutory requirement
majority of voting members of the ASC state the full document name: ‘‘HL7 to use a standard for electronic health
X12N subcommittee and the executive Additional Information Specification care claims attachment transactions, and
committee of X12 itself. Implementation Guide,’’ or HL7 AIS IG. to facilitate the transmission of certain
HL7: To establish its standards, HL7 We do not otherwise refer to types of detailed clinical information to
conducts a three-step process. First, ‘‘implementation specifications’’ or support an electronic health care claim.
standards are developed and accepted distinguish between ‘‘standards’’ and In the final Transactions Rule, new
or rejected by voting at the technical ‘‘implementation specifications.’’ parts 160 and 162 were added to title 45
committee level. All HL7 members are The 4050 versions of the X12 of the Code of Federal Regulations (65
eligible to vote on standards, without Implementation Guides are compatible FR 50365). The provisions in this
regard to whether they are members of with the current X12 4010 guides proposed rule would be placed in a new
the committee that wrote the standard. adopted for HIPAA transactions— subpart S of part 162 which would
Non-members may also vote on a given version 4010–1a so that the two contain provisions specific to the
ballot for a standard, for which privilege transactions can be used together as electronic health care claims attachment
they pay an administrative fee. HL7’s necessary. In other words, a claims standards. The provisions of this new
policy states that it shall assess an transaction (837 version 4010–1a) may subpart can be implemented
administrative fee for the processing, be accompanied by a health care claims consistently with the provisions of the
handling, and shipping of the ballot attachment response transaction (275 HIPAA Privacy Rule and Security Rule,
package. The administrative fee does version 4050). Public comments on the which are codified mainly at subparts
not exceed the fee associated with an draft versions of the X12 A, C, and E of part 164 of title 45 of the
individual membership in HL7. Second, Implementation Guides for version 4050 Code of Federal Regulations.
HL7 technical committees and special of the X12N 277 and X12N 275 were
interest groups vote on solicited between December 5, 2003 and A. Definitions
‘‘recommendations’’ and at least two- January 9, 2004. The current guides may [If you choose to comment on issues
thirds of the total votes must be positive be obtained from http://www.wpc- in this section, please include the
for approval. Third, if approved at the edi.com. caption ‘‘DEFINITIONS’’ at the
technical committee level, the The other set of documents proposed beginning of your comments.]
recommended standards are submitted for use with electronic health care Section 1171 of the Act defines
to the entire HL7 organization for claims attachments are called HL7 several terms. The definitions set out in
approval. Finally, they are submitted to Additional Information Specifications section 1171 of the Act and regulations
ANSI for certification. (AIS). These were drafted by the HL7 at 45 CFR part 160 and subpart A of part
ASIG work group and were balloted and 162 would also apply to the electronic
2. Implementation Guides in HIPAA approved by HL7 in September 2003. health care claims attachment
Regulations These AIS are used in concert with the standards. There are also several new
Section 1172(d) of the Act directs the X12 Implementation Guides and terms and definitions proposed that are
Secretary to establish specifications for provide the instructions for the use of related to the standards proposed in this
implementing each of the standards the proposed code set, to be described rule, (see proposed §162.103 and
adopted under this part. later in this preamble. The adoption of §162.1900). The new terms, their
For electronic transaction standards, the HL7 documents would fulfill the definitions and examples or
the SDOs developed ‘‘Implementation legal mandate for the Secretary to explanations thereof are as follow:
Guides’’ for implementing the same establish the implementation 1. Ambulance Services means health
standards for a number of different specifications for the HIPAA standards care services provided by land, water, or
business purposes. For example, the proposed for adoption in accordance air transport, and the procedures and
general ASC X12 claim, the 837, has with 1172(d) of the Act. supplies used during the trip by the
separate implementation guides that The X12N Implementation Guides, transport personnel, to assess, treat or
permit its use in automobile, liability, HL7 AIS IG, HL7 AIS, and the LOINC monitor the individual until arrival at
and health care claims. The approach code set proposed for adoption in this the hospital, emergency department,
taken in the final Transactions Rule was proposed rule, are all copyrighted by home or other destination. Ambulance
to adopt a specific ‘‘Implementation their respective organizations, and each documentation may also include non-
Guide’’ as both the ‘‘standard’’ and the document includes a copyright clinical information such as the
‘‘implementation specifications’’ for statement. The copyright protection destination justification and ordering
each health care transaction. ensures the integrity of the materials practitioner.
The regulations text of this proposed and provides appropriate attribution to 2. Attachment Information means the
rule also adopts the referenced guides as the developers. The materials are all supplemental health information
needed to support a specific health care those the individual is taking before an health information system. Standard
claim. The health care claim attachment encounter that generates a new claim; electronic health care claims
information is conveyed using both an medications administered are those attachments will allow for the electronic
X12 transaction and HL7 specification. given to the individual by a health care exchange of additional clinical and
3. Clinical Reports means reports, provider during the encounter; and administrative information to augment
studies, or notes, including tests, discharge medications are those that the the HIPAA standard claim transaction.
procedures, and other clinical results, health care provider orders for the The goal of having a more automated,
used to analyze and/or document an individual to take and use after release standardized approach to the exchange
individual’s medical condition. These or discharge from the encounter, of information in the health care
include discharge summaries, operative including the medications the industry is longstanding. In 1994, the
notes, history, physicals, and diagnostic individual may already have at home or Workgroup for Electronic Data
procedures (radiology reports, those he or she may need to obtain Interchange (WEDI) conducted a survey
electrocardiogram (for example, EKG), following treatment. of the U.S. health care industry and
cardiac echoes, gastrointestinal tests, 8. Rehabilitation services means those documented its findings in a paper
pathology, etc.) Clinical reports do not therapy services provided for the entitled: WEDI Attachments Workgroup
include psychotherapy notes. primary purpose of assisting in an Report, Initial Findings. Among other
4. Emergency department means a individual’s rehabilitation program of issues, this study examined the state of
health care facility or department of a evaluation and services. These services the health care industry as it related to
hospital that provides acute medical are: Cardiac rehabilitation, medical the use of, and need for, electronic
and surgical care and services on an social services, occupational therapy, health care claims attachments
ambulatory basis to individuals who physical therapy, respiratory therapy, standards. The survey identified
require immediate care primarily in skilled nursing, speech therapy, hundreds of different paper-based
critical or life-threatening situations. psychiatric rehabilitation, and alcohol attachments formats being used with
5. Laboratory Results means the and substance abuse rehabilitation. health care claims. The attachments and
clinical information resulting from tests their formats ranged from simple to
conducted by entities furnishing B. Effective Dates complex and varied according to the
biological, microbiological, serological, [If you choose to comment on issues type of information being requested, the
chemical, immunohematological, in this section, please include the services involved, and who was asking
hematological, biophysical, cytological, caption ‘‘EFFECTIVE DATES’’ at the for the information. The WEDI report
pathology, or other examinations of beginning of your comments.] concluded with a set of
materials from the human body. Covered entities must comply with recommendations, including the
Laboratory results are used for the the standards for electronic health care development of an electronic standard
diagnosis, prevention, or treatment of claims attachments 24 months from the for exchanging this type of information
any disease or impairment of, or effective date of the final rule unless between health care providers and
assessment of, the health of the they are small health plans. Small health plans. Key among the
individual. Laboratory results are health plans will have 36 months from recommendations were that: (a)
generated from the services provided in the effective date of the final rule to Standardized data elements should be
a laboratory or other facility that come into compliance. created for electronic claims
conducts those tests and examinations. attachments; (b) collaboration between
6. LOINC stands for Logical C. Overview of Key Information for
Electronic Health Care Claims affected entities should be encouraged;
Observation Identifiers Names and (c) standard ways to link data across
Codes (LOINC). It is a code set that Attachments
transaction sets should be developed;
provides a standard set of universal For the remainder of this document, and (d) a transaction set (pair of
names and codes for identifying we will use the terms electronic claims transactions) should be selected to send
individual laboratory and clinical attachments or electronic attachments to and respond to requests for additional
results as well as other clinical mean the same thing as electronic information (similar to the health care
information. LOINC codes are health care claims attachments. claims status request and response
developed and maintained by the Similarly, the term Additional transactions—the X12N 276/277 pair).
LOINC committee and copyrighted Information Specification may be CMS’s work in the mid-1990s with
1995–2004, by Regenstrief Institute, referred to as an attachment WEDI, ASC X12, and HL7 resulted in
Inc., and the Logical Observation specification or an AIS, and these terms the recommendation to use an HL7
Identifiers Names and Codes (LOINC) are used interchangeably throughout the version 2.4 message embedded within
Committee. text. Since the term ‘‘Implementation version 3040 of the ASC X12N 275
7. Medications means those drugs and Guide’’ is used by both HL7 and X12, ‘‘Additional Information to Support a
biologics that the individual is already we therefore use the full title for each Health Care Claim or Encounter
taking, that are ordered for the document when they are referenced, Transaction,’’ in other words, a response
individual during the course of such as the ‘‘HL7 Additional to a request for information. The
treatment, or that are ordered for an Information Specification embedded HL7 message would have
individual after treatment has been Implementation Guide.’’ contained structured and codified
furnished. Medications include drugs This rule proposes to establish attachment data using the LOINC
and biologics that are ordered by a standards for electronic health care coding system. For a variety of reasons,
licensed practitioner, or that are being claims attachments. The proposed rule a proposed rule was never released with
taken by the individual, independent of is specific to electronic health care this recommendation. Since that time,
a health care provider’s orders (for claims attachments rather than paper HL7 moved ahead with development of
example, over-the-counter drugs). In the attachments (hard copy medical its Clinical Document Architecture
AIS documents, these are referred to as records), since the purpose of the (CDA), which was a significant
‘‘current medications,’’ ‘‘medications HIPAA administrative simplification enhancement over the HL7 version 2.4
administered,’’ and ‘‘discharge provisions is to facilitate the messaging. The CDA Release 1.0,
medications.’’ Current medications are development of a national electronic August 2003, is an XML-based
document specification that enables the also formats it attractively, similar to approved by HL7 in November 2000. It
standardization of ‘‘clinical documents’’ HTML. In fact, XML and HTML are is a document markup standard
for electronic exchanges of health increasingly used together—XML stores encoded in XML that specifies the
information (see explanation of XML and organizes the data, while HTML structure (format) and semantics
below). The CDA became the first ANSI- renders it inside the browser or (content) of ‘‘clinical documents’’ for
accredited XML-based standard in the application. the purpose of information exchange.
health care industry. XML was originally published by the These XML-coded documents have the
There is increasing evidence that World Wide Web Consortium (http:// same characteristics and information as
many health care organizations, www.w3c.org) and designed as a
hard copy clinical documents, and
including health plans, health care standard markup language to speed up
therefore can be processed by both
providers, and health care and simplify data exchange and
clearinghouses, plan on implementing database connectivity and to enhance people and machines. The clinical
more XML-based EDI tools. Thus, the creation of complex documents. documents encoded in XML include a
building electronic health care claims XML effectively structures files into hierarchical set of document
attachments using XML technology is in logical elements of information by the specifications (the architecture) and are
concert with the direction of the use and placement of tags which rendered in human readable form using
industry. In light of these developments, describe the kind of information being XSL. This makes them usable in either
we believe that the timing for this sent. Information organized using XML, electronic or printed format. The XSL
proposed rule is reasonable because its and bounded by tags, is known as a essentially translates the XML into a
publication and the years allowed for document whether it is in a file, or format that looks like a ‘‘regular’’ plain
implementation should leave ample whether it is being transmitted over the text document.
time for the industry to further develop Internet or in any other technical We are aware that HL7 continues to
its skills with XML and EDI exchange environment. The process of arranging improve its standards, including the
methodology. information between tags is called
CDA. In fact, CDA Release 2.0 was first
The HL7 standard being proposed document markup.
here would allow the same records and Over the past few years, XML has balloted in August 2003 and re-balloted
data to be ‘‘read’’ and used by either been adopted by most major companies in 2004. While Release 2.0 may be
people or computers. In other words, in information technology as the basis approved between the time of this
regardless of how the data are sent for attaining interoperability among proposed rule and the final rule, this
within the proposed transaction, they their own products. One of the special proposed regulatory text does not
can be processed either manually or features of the XML family is the suggest its adoption at this time.
through automation. Furthermore, as standard language for describing the However, if Release 2.0 is approved by
entities move toward computer-based transformation or conversion of an XML HL7 between the time of this proposed
methods for adjudication, the costs of document into another format. rule and the final rule, we may propose
copying, coding, transcribing, storing, Extensible Stylesheet Language, or XSL, its adoption for future AIS, based on the
and processing records should begin to is the language that contains the impact of CDA Release 2.0 on the
decrease. Thus, this proposal has the presentation format instructions for the existing AIS. As part of CDA Release
potential for helping the industry attain document, similar to HTML. It allows 2.0, HL7 is developing an XSL
desired efficiencies, expedite payments, the display of information in different stylesheet that would permit
reduce fraud and abuse, and improve media, such as a computer screen or a interoperability between Release 1.0 and
the accuracy of medical information. paper copy, and it enables the user to Release 2.0. However, as this too is
view the document according to his or incomplete, it is premature to consider
1. Overview of Extensible Markup
her preferences and abilities, just by its use or viability at this time. We
Language (XML)
changing the stylesheet. XSL Version
Extensible Markup Language, or XML, invite comment on the pros and cons of
1.0 is important because it can convert
is a relatively new technology. It allows an XML document into Extensible each CDA release, the issues related to
documents to be formatted and HTML, which can be understood by the use of a stylesheet to permit use of
exchanged across the Internet or current Web browsers and many either CDA release, and the costs and
through EDI. common applications. In fact, each HL7 timing associated with implementing
Hypertext Markup Language (HTML) AIS for the electronic claims attachment one release version over the other.
is a widely used presentation language standards will include a fully functional
used to create documents for display on 3. How XML Is Applied Within the
XSL stylesheet for use by covered Clinical Document Architecture
the Web. Using HTML markup with entities. If covered entities choose not to
text, links, and graphics creates an use the HL7 supplied stylesheet, they As with any XML-based standard, the
HTML document that is attractive in will be able to create their own without CDA defines tag names and how they
appearance. HTML was created to significant problems, assuming the nest to structure information. Some of
describe how the content of a page expertise exists on staff or is available the important tag names are shown in
should be displayed, but not the actual through a vendor. the table below. The indentation in the
contents of the page. XML fills this gap
2. Overview of Clinical Document left column of the table shows the
because it provides an intelligence to
electronic documents and preserves Architecture manner in which certain elements nest
both the content (the actual information) The HL7 Clinical Document within other elements.
and semantics for the document, and Architecture (CDA)—Release 1.0 was
DEMONSTRATION OF HOW XML IS USED WITHIN A CDA DOCUMENT

Tag name Purpose
<level one> ......................................................... Outermost tag, contains an entire CDA document.

<clinical_document_header> .............................. Contains information about the document arranged in subsections.
<Document_typ_ed> ........................................... Contains a code that identifies the document type (for example, a discharge summary or car-
diac rehabilitation plan).
<Patient> ............................................................. Contains the name and identification number of the patient (individual).
<Body> ................................................................ Contains the body of the report expressed in natural language with optional structured infor-
mation.
<Section> ............................................................ A subdivision of the body containing a logical unit of information (for example, the discharge
medications).
<Caption> ........................................................... A subdivision of sections and other elements that describes the contents that will follow.
<caption_cd> ....................................................... A subdivision of a caption that identifies the contents that follow using a LOINC code.
Source: HL7 white paper August 26, 2003. Specific to Release 1.0 of the CDA.
An important feature of the CDA is imaged documents. The X12N towards moving the industry from paper
that it allows the entire body of the XML transactions are flexible enough to to electronic communication for health
document to be replaced by an actual accommodate the two format variants care claims attachments. The advantage
image. The image might be a scanned described in the next section, meaning of the more general X12N transaction
copy of a page or pages from the the transaction can be used for either standards that can serve as the vehicles
medical record. The header is still manual processing or computer to carry any type of electronic
present to support computer automated processing. attachment information, is that they can
management of the document, but the 5. Electronic Claims Attachment Types be coupled with the specific attachment
clinical content can be conveyed ‘‘documents’’—coded or scanned—and
entirely by an image or text document. [If you choose to comment on issues remain available to handle new content-
This option is important to those health in this section, please include the specific electronic attachment types as
care providers that do not have a caption ‘‘ELECTRONIC CLAIMS they are developed and approved.
computer-based patient record system ATTACHMENT TYPES’’ at the
beginning of your comments.] Based on industry feedback following
and cannot yet create electronic claims implementation of the Transactions
attachments in a structured format, but While it might be considered ideal by
some to have electronic attachments for Rule, it became clear that pilot programs
wish to reap some benefits from and early testing of new standards and
standardization and a certain level of all health care claims business needs, it
would be virtually impossible to processes were vital to the standards
automation. adoption process. In July 2004, HHS
identify and create standard
4. Transactions for Transmitting specifications with appropriate codes awarded funds for a Medicare pilot
Electronic Attachments for the full array of different attachment program to test the X12 request and
types required today. Furthermore, response transactions, the LOINC
As we describe in a later section given changes in industry business codes and at least two of the attachment
entitled ‘‘Candidates Considered,’’ the practices, and new adjudication rules types, using the HL7 Additional
standard setting organizations attempted over the past decade, it is more Information Specifications. The pilot is
to evaluate existing transactions for important to determine, from health expected to demonstrate the capability
their potential to be used to send and care providers and health plans, which of sending the X12 request transaction
receive attachment information claims most commonly require from a health plan to a health care
electronically. Two transactions were additional information for adjudication provider, and then for the health care
ultimately selected because they only today, and what types of electronic provider to send the X12 response,
required modifications in a later attachments might be required in the complete with the HL7 CDA in the BIN
version. In other words, while the next 5 to 10 years. It is equally segment, back to the health plan. The
existing X12N version 4010 standards important for covered entities to gain health care provider will send both
did not satisfy the data content needs of experience with a manageable number variants of each attachment type—a
the electronic health care claims of electronic attachment types at the human variant (scanned document) and
attachments, revisions in version 4050 outset, so that technical and business a computer variant (a coded response).
were made to accommodate these needs issues can be identified to improve the These variants are described later in this
in time for this proposed rule. Thus, process with each new electronic preamble. We believe this pilot program
version 4050 of the X12N 277 ‘‘request’’ attachment specification that is will provide valuable insight as to the
and version 4050 of the X12N 275 developed. implementation challenges of electronic
‘‘response’’ are proposed to carry the While the attachment information attachments, and perhaps even as to
attachment related questions and the needed to support the full range of when health care providers and health
related answers or responses. The X12N health care claims may be diverse, the plans could begin to move towards more
277 version 4050 transaction transmits same general transaction structure and structured, coded communication and
information about the particular claim administrative information can be adjudication. The SDOs are involved in
in question and the question codes. The applied to all electronic claims the pilot as subject matter experts, so
X12N 275 version 4050 transaction attachments to allow for some level of that as technical or operational
returns the claim identification (ID) consistency. This proposal to encourage challenges are identified with the
information, and, in the Binary Data some form of electronic transmission, standards, a core group of professionals
(BIN) segment, literally transports the even of a scanned document in the early with expertise can address them, and
responses to each question, with the stages of implementation, at least take corrective action on the X12
response codes, narrative text, or actual represents a methodical approach Implementation Guides, HL7 AIS or
LOINC code set before the final rule is advance their own proposals for these provider and the health plan but that
issued. and other electronic attachments. would not require a large upfront
In this proposed rule, we propose six Any new electronic attachment investment in electronic medical
specific electronic attachment types, specifications, such as the ones records systems, or the immediate
each with data content requirements referenced above, will be developed in merging of financial/administrative and
related to treatment or services accordance with the framework of the clinical systems. Under this proposal,
provided. These six attachments are: (1) HL7 CDA Release 1.0. If CDA Release the electronic health care claims
Ambulance services, (2) emergency 2.0 is approved, the HL7 ASIG will attachments may be sent in one of three
department, (3) rehabilitation services, determine if the next set of AISs will formats, shown in the table below. Two
(4) clinical reports, (5) laboratory use CDA Release 2.0, or continue to be of the formats are in the category of
results, and (6) medications. These six built on Release 1.0. HL7 will advise Human Decision Variant, and the third
specific attachments were originally HHS as to the industry impact if the format is a Computer Decision Variant.
selected for development because there later version of CDA is adopted, There is a lengthy discussion of these
was industry consensus on their particularly since covered entities need variants along with examples later in
relevance to a significant percentage of to be able to use both versions without this preamble, based on a white paper
covered entities and to those claims that requiring additional system changes. written by members of HL7’s
typically require additional Industry representatives interested in Attachments Special Interest Group.
documentation. They also contain the participating in the development Human Decision Variants: (1) Many
types of information commonly found process should work in collaboration health care providers may choose to
in attachments, for example, narrative with HL7. send scanned or imaged documents in
text (such as nurses’ notes), simple data In fact, as these and other new the X12 transaction, and health plans
points (such as the results of a single electronic attachments are developed, will use manual procedures to process
laboratory test), and more complex we strongly encourage the health care them; a health plan employee will
information (such as rehabilitation provider and health plan segments of physically look at the contents of the
progress over time). In 2003, the HL7 the industry to review them and then attachment to adjudicate the claim.
ASIG work group began working on provide substantial input on the Simply put, the health care provider
other electronic claim attachment ‘‘questions’’ or LOINC codes, and on would send a virtual document inside
specifications that were identified by the cardinality (priority values) of the the X12 transaction and the health plan
the industry as being significant, data elements—in other words, which would view it on the computer screen,
including home health, periodontal elements should be required and which or a printed hard copy. This process is
care, and durable medical equipment should be situational or optional for one of the human decision-making
(DME). each electronic attachment type. Health variants because it allows for the
Comments are invited as to whether care providers and health plans will transmission of scanned page images.
the six proposed attachment types are recall their implementation experiences After the image has been rendered
still the most frequently requested by with the Transactions Rule and have an (printed or viewed as a document), the
health plans, and if there are others that appreciation of the extreme importance information should be clear enough and
are equally or more pressing for the of evaluating and understanding both contain sufficient data for a person—the
industry. the technical and business requirements health plan’s employee—to make a
In the future, any new electronic of the standards and guides, and of decision about the claim. (2) The second
attachment types, or changes to the six submitting their issues and type of human decision variant is even
attachments standards proposed here, recommendations to the SDOs, DSMOs, simpler: The health care provider
would require the Department to follow and the regulators. We also solicit responds to the electronic request using
the usual rulemaking process. If changes industry input on the impact to servers narrative text, such as a typed response
are requested of the six proposed and other data storage systems for to the question, again embedding this
attachments standards, as a result of processing and storing electronic files of response into the BIN segment of the
public comments during the period clinical information, both coded and X12 transaction. The health plan
between the proposed and final rule, it text or image based. employee reads the answer off the
is highly likely that HL7 would be able screen, or prints a hard copy for review.
to make and ballot such changes in time 6. Format Options (Human vs. Computer Decision Variant: The
for their adoption in the final rule. New Computer Variants) for Electronic computer decision variant contains
electronic attachment standards Claims Attachments additional information that is structured
approved by the SDO but not adopted [If you choose to comment on issues so that it can be electronically extracted
by the Department may be used on a in this section, please include the for use in computer-based adjudication
voluntary basis between trading caption ‘‘FORMAT OPTIONS’’ at the systems, using automated processing
partners, but there is no regulatory beginning of your comments.] rules. The codes will literally be read
authority over their use. The Department and the standard and interpreted by the computer. Auto-
The effect of adopting a limited setting organizations are sensitive to the adjudication is the use of computers,
number of attachments standards at first fact that many health care providers, programmed with business rules and
is to permit covered entities time to gain particularly smaller practices that are logic, to process a claim, making
experience with new standards and to not yet fully automated, may be looking decisions as to whether to pay, how
evaluate the technical and business for means to convert from paper to much to pay, and to whom to make the
impacts of such transactions. In the electronic records in a cost effective, payment. It is a long-term goal for most
meantime, while the electronic staged manner. To encourage such a health plans to be able to support auto-
attachment specifications for DME, transition, the standard setting adjudication for as many claims as
periodontal care, and home health are organizations have proposed an possible.
still under development, covered approach to electronic health care Even with this variant, HL7 will
entities are strongly encouraged to claims attachments that could provide supply ‘‘stylesheets’’ that will put any
actively participate in the development, the benefits of electronic transmission of data into an HTML or screen readable
review and modification process, and to the information for both the health care format. This means that health plans
that do not intend to auto-adjudicate in each electronic attachment type have variants, coded data are not required.
the short term, may continue to use low- required and optional content elements, While both variant types will carry a
cost technology to print or display the which are listed in the specification for LOINC code or codes, they will be
electronic attachment information, that attachment. Both types of variants accompanied by the natural text
regardless of which option or variant the will satisfy the standard, as they will translation (narrative text) in the same
health care provider uses. differ only with regard to whether or not transaction, so the request will be
The human and computer variants do structured and coded data are required. understandable in either the human or
not differ in actual content. Both types That is, in the computer variant, coded the computer variant.
of variants (human and computer) for data are required, whereas in the human
TABLE 1.—HUMAN VS. COMPUTER VARIANTS FOR ELECTRONIC ATTACHMENTS

Variant Information representation Information sent as * * *
Human Decision ................................................. Scanned image ................................................ Scanned image of pages from the medical
record. Repeats LOINC code from the re-
quest.
Human Decision ................................................. Natural language text ....................................... Natural language text with captions that
match the specified questions. Repeats
LOINC code from the request.
Computer Decision ............................................. Natural language text and structured informa- Natural language text, captions identified by
tion. LOINC codes and supplemented by coded
information.
Source: Gartner Research 2003.
7. Combined Use of Two Different claims attachments. The ASIG included D. Electronic Health Care Claims
Standards Through Standard HL7 representatives, members of X12’s Attachment Business Use
Development Organization (SDO) WG9, and several vendors and health A health care claims attachment
Collaboration care providers with HL7 experience.
conveys supplemental information
[If you choose to comment on issues The purpose of proposing the combined
pertaining to the services provided to a
use of both ASC X12N and HL7
in this section, please include the specific individual to support
standards is to address both the
caption ‘‘COMBINED USE OF evaluation of a claim before it is paid.
administrative and clinical aspects of
DIFFERENT STANDARDS’’ at the An attachment might contain biometric
the attachment transactions from a
beginning of your comments.] data; medical history; clinical data
format and content perspective.
As discussed in the previous section, (reports, studies, notes); hospital
However, because these two standards
claims attachment transactions contain discharge notes; laboratory results;
have not been used together before, we
both administrative and clinical medication information; rehabilitation
solicit industry feedback regarding this
information. Thus, attachment data plans; optical prescriptions;
strategy.
could come from a health care One of the benefits of standardizing certifications made by the individual
provider’s clinical record system, health care claims attachments is that it and/or the health care provider
whether paper or electronic, as well as allows health care providers to regarding sterilization, hysterectomy, or
from its practice management or billing anticipate requirements from health other services, as required by Federal or
system. Historically, these two distinct plans regarding additional State rules; or other clarifying
areas (clinical vs. administrative) have documentation for claims adjudication. information for a particular service.
been the domain of two different SDOs: This should present opportunities for Attachments may be requested or
HL7 focuses on clinical data standards, providers to develop procedures and submitted when the supplemental
while X12 concentrates on systems to collect the data specified in medical information is directly related
administrative data and transactions. In the X12 Implementation Guides and to the determination of benefits under
1997, a joint effort between HL7 and HL7 Additional Information the subscriber’s contract, or when
X12 produced several options that Specifications. Health care providers directly related to providing medical
would facilitate the communication of would also be given considerable justification for health care services
both clinical and administrative data, as latitude on how to submit the provided to the individual when that
well as smooth the transition from paper information—with either narrative text, medical justification can affect the
to a standardized electronic process for scanned documents or with fully coded adjudication of payment for services
health care claims attachment data, permitting the use of some form of billed by the provider of health care
information. electronic attachments for health care services. Although additional clinical or
ASC X12N, through its Patient providers that do not have computer- administrative information may be
Information Standards Work Group based medical record systems. required following adjudication of
(WG9), developed transactions and the From the health plan perspective, the claims, such as for post-adjudication
accompanying X12 implementation requirements for use of the two review to support quality control, fraud
guides to fulfill the administrative needs standards can be met with a low impact and abuse, or other post-adjudication
of an electronic attachment request and implementation for claims adjudication, reviews and reporting requirements, we
the response to that request. HL7, based on a person looking at the content do not consider these post-adjudication
through its ASIG, developed the of the electronic attachment in a text/ requests for claims-related data to be
message structure and the additional readable format, regardless of how it is part of the claims payment process.
information specifications employing submitted. While the proposed process Therefore, post-adjudication processes
LOINC codes that were relevant to the supports auto-adjudication, it does not are not covered by this proposal. While
major types of clinical data needed in require it for compliance. covered entities may voluntarily choose
to use the standard transaction format unsolicited attachment because a plans handle Coordination of Benefits
and structure for requesting and request was not made after the fact, (COB) and the communication of related
submitting these types of attachments, using the standard request transaction. claims information. However, with
those transactions are not considered We are proposing that health care respect to electronic attachment
electronic claims attachments as defined providers may submit an unsolicited requests and responses in a COB
in this proposed rule. electronic attachment with a claim only scenario, we assume that the primary
when a health plan has given them health plan will request only the
1. Electronic Health Care Claims
specific advance instructions pertaining attachments it needs to adjudicate its
Attachment vs. Health Care Claims Data
to that type of claim or service. portion of the claim. The secondary
Electronic health care claims We are proposing such a restriction health plan would request its own
attachments must not be used to convey around ‘‘unsolicited’’ electronic attachments in a separate (X12N 277)
information that is already required on attachments, because we believe that transaction sent directly to the health
every claim. Information needed for there are legal, business, and technical care provider. In health plan-to-health
every claim is ‘‘claims data’’ that must implications for health care providers, plan (also known as payer-to-payer)
be conveyed in the appropriate standard health plans, and their business COB transactions, the primary health
claim transaction. The purpose of a associates for handling and processing plan may not know the secondary
claims attachment is to convey unsolicited attachments without prior health plan’s business rules, and
supplemental information that is direction. If health care providers were therefore would not be expected or
directly related to one or more of the permitted to submit unsolicited required to request an attachment on
services billed on the claim submitted electronic attachments with any claim behalf of the secondary health plan.
by the health care provider when further without prior arrangement with the
explanation of those services is required health plan, there would be a number of 4. Impact of Privacy Rule
before payment can be made by the issues, including compliance with the Before implementation of the Privacy
health plan. There are even some Privacy Rule’s minimum necessary Rule in 2003, health care providers
current business practices that include standards, and identifying the new often sent the individual’s entire
100 percent pre-payment medical business and technical procedures medical record to the health plan for the
review. This is when a health plan health plans would need to develop to purpose of justifying a claim. Health
requires a specific health care provider review, evaluate, store, return, or plans and health care providers
to include certain supplemental destroy the unsolicited documents. indicated that this practice reduced
information with all claims for a certain Similarly, health care providers would instances for which follow-up requests
type of service. need systems and processes to track for more information were needed, since
Over the past few years, health plan submissions and returns. all possible information was supplied at
rules and policies regarding the We also propose that for each specific once. That practice was often wasteful
additional data necessary to adjudicate claim, health plans may solicit only one and time consuming, and it is now
a claim have evolved, and in fact, many electronic attachment request generally inconsistent with the
health plans have begun to limit or transaction which would have to ‘‘minimum necessary’’ standards
reduce their requests for claims include all of their required or desired contained in the HIPAA Privacy Rule at
attachments. Therefore, it is critical that ‘‘questions’’ and/or documentation 45 CFR 164.502(b) and 45 CFR
members of the health plan industry needs relevant to that specific claim. 164.514(d). These standards require
and the health care provider community Health care providers would be required covered entities to make reasonable
actively engage themselves in the final to respond completely to the request, efforts to limit requests for, or
development of this proposed rule so using one response transaction. The disclosures of, protected health
that the proposed attachments are intent of these proposed requirements is information to the minimum necessary
indeed those which will yield to avoid inefficient, redundant to accomplish the intended purpose of
significant benefits to health care processes. A health plan would not be the request or disclosure. In situations
providers and health plans alike. able to extend adjudication through a where the minimum necessary standard
lengthy process of multiple individual applies, such as when a covered health
2. Solicited vs. Unsolicited Electronic care provider discloses protected health
attachment requests for the same claim:
Health Care Claims Attachments information to a health plan for
submitting one LOINC request code at
[If you choose to comment on issues a time, receiving the health care payment, the standards prohibit
in this section, please include the provider’s response, and then disclosure of the entire medical record
caption ‘‘SOLICITED vs. UNSOLICITED submitting another transaction with unless the entire medical record is
ATTACHMENTS’’ at the beginning of another LOINC code for additional specifically justified as the amount that
your comments.] information related to the same claim. is reasonably necessary to accomplish
In general, health care providers will Nor would a health care provider be the purpose of the disclosure (45 CFR
submit their electronic health care able to send bits and pieces of the 164.514(d)(5).
claims attachment information to the requested information at different times The Privacy Rule exempts from the
health plan for certain claim types, or dates. We propose this because it minimum necessary standard any use or
upon request, after the health plan has seems contrary to the goals of disclosure that is required for
received and reviewed the claim. This administrative simplification for compliance with the Transactions Rule
follows the course of claims covered entities to engage in a (45 CFR 164.502(b)(2)); thus, the
adjudication today. Health plans may continuous loop of query and response minimum necessary standard does not
also request, in advance, that additional in order to have a claim processed. apply to any required or situationally
documentation (the attachment) We solicit feedback from the industry required data elements in a standard
accompany a certain type of claim for a on this issue. transaction. For example, if an identifier
specific health care provider, procedure, code were required on all electronic
or service. The ASIG refers to this 3. Coordination of Benefits attachment request transactions to
scenario, of sending attachment There is considerable variation in create a connection between the
information with the initial claim, as an how health care providers and health electronic attachment request
transaction and the associated health measures required by the Security Rule We are aware that virtually all health
care claim, then health plans would not fall generally into three categories: plans, including the Medicare and
need to apply the minimum necessary administrative, physical, and technical Medicaid programs, require signatures
standard to that data element to safeguards. The Security Rule also has certifying certain types of services, such
determine whether they could request standards for documentation and as sterilization, certain rehabilitation
that information. However, the organization requirements. Since the plans, and authorization for certain
minimum necessary standard would requirements are intended to be types of equipment. For example, health
apply to data elements for which health scalable, each covered entity must take plans may request a paper copy of the
plans or health care providers may into account its size, complexity, signature page of a rehabilitation plan,
exercise discretion as to whether the capabilities, technical infrastructure, or they may accept the response code
information should be provided or and hardware and software security indicating that the signature is on file.
requested in the transaction. For capabilities; the cost of security The CDA Release 1.0 requires the
example, health plans must apply the measures; and the probability and acquisition of the signature to be
minimum necessary standard when criticality of potential risks to EPHI. documented via the <signature_cd>
selecting the attachment information to The systems used to transmit component, so there is an
be requested in a particular electronic electronic claims attachments will likely accommodation for signature within the
attachment request transaction. be the same systems used for other standard, but not a requirement for an
A health care provider may rely, if electronic transactions. Therefore, any electronic signature specific to HIPAA.
such reliance is reasonable under the efforts to comply with the Security Rule We solicit input from the industry on
circumstances, on a health plan’s should be effectively incorporated into how signatures should be handled when
request for information, or specific electronic attachment processing. an attachment is requested and
instructions for unsolicited attachments, submitted electronically.
Most covered entities (with the
as the minimum necessary for the
possible exception of small health 7. Connection to Consolidated Health
intended disclosure. Such reliance is
plans) will be in compliance with the Informatics Initiative
not required, however, and the covered
Security Rule by the time of this Several agencies within the Federal
health care provider always retains the
proposed rule; and all health plans will government that deal with the delivery
discretion to make its own minimum
have fully implemented their security of health services, including the
necessary determination.
For health care providers who choose programs by the time the final rule is Departments of Health and Human
to submit attachment information in the published for electronic health care Services, Veterans Affairs, and Defense,
form of scanned documents, efforts will claims attachments. have adopted a portfolio of health
need to be made to ensure that those 6. Connection to Signatures (Hard Copy information interoperability standards
documents do not contain more than the and Electronic) that will enable all agencies in the
minimum necessary information. Federal health enterprise to ‘‘speak the
We solicit comments on the extent to This regulation does not propose same language’’ based on common,
which the use of the proposed requirements for Electronic Signatures enterprise-wide business and
electronic attachment standards will (e-signatures) because a consensus technology architecture. This program is
facilitate the application of the standard does not presently exist that known as he Consolidated Health
‘‘minimum necessary’’ standard by we could propose to adopt, nor does any Informatics (CHI) initiative. In 2003,
covered entities when conducting Federal standard currently govern the CHI targeted 24 ‘‘domains’’ for data and
electronic health care claims attachment use of electronic signatures for private messaging, from laboratory results to
transactions. sector health care services. Federal vocabulary for nursing, to medications.
agencies that are also covered entities The CHI initiative looked to the private
5. Impact of the Security Rule have to comply with the Office of sector to identify particular electronic
All covered entities need to comply Management and Budget (OMB) health clinical data standards for
with the Security Rule no later than guidance on e-signatures in the context adoption, researched these standards,
April 20, 2005, except for small health of the Government Paperwork and is now beginning to build the plan
plans, which must comply no later than Elimination Act (OMB notice 5/2000, 65 to implement them within Federal
April 20, 2006. The Security Rule FR 25508) and the Federal Information agencies as program requirements
applies to all covered entities, and, Security Management Act (Title III of dictate. On May 6, 2004, the Secretaries
therefore, will apply to the transmission the E-Government Act of 2002). And, adopted standards for 20 domains and
of electronic health care claims while the OMB has responsibility for subdomains; among others, these
attachments. There are four overarching coordinating and implementing the included: HL7 messaging standards for
security requirements with which adoption and use of electronic signature clinical data, NCPDP standards for
covered entities must comply: (1) technologies for Federal agencies, this ordering from retail pharmacies,
Ensure the confidentiality, integrity, and effort is not related to HIPAA IEEE1073 to allow health care providers
availability of all Electronic Protected transactions per se, and we do not have to monitor medical devices, DICOM to
Health Information (EPHI) that the authority to require the private sector to enable images of diagnostic information
covered entity creates, receives, comply with rules that are only to be retrieved and transferred between
maintains, or transmits; (2) protect applicable to Federal agencies. At the devices and workstations, LOINC for
against any reasonably anticipated time of this proposed rule, other the exchange of clinical laboratory
threats or hazards to the security or agencies and Federal initiatives results, SNOMED CT for certain
integrity of EPHI; (3) protect against any involved in the evaluation and interventions, diagnosis and nursing
reasonably anticipated uses or development of standards for electronic terminology, and a variety of
disclosures of EPHI that are not signatures include the Department of terminologies for medications. We
permitted under the Privacy Rule; and Defense (DOD), the National Institute for include a reference to CHI here to clarify
(4) ensure compliance with the security Standards and Technology (NIST), and that while the Federal government is
regulations by members of the the Federal Consolidated Health reviewing and adopting standards for its
workforce. The types of security Informatics Initiative (CHI). intra-agency communications, these are
not inconsistent with the private sector, health plan accept the attachment cannot adjudicate the claim without
with whom significant transactions are information in the standard response knowing M. Smith’s weight. The health
exchanged, and that furthermore, the transaction. plan sends a request for the individual’s
work and outcome of CHI related However, as we have stated in the weight to ABC Ambulance Company
activities do not conflict with HIPAA. past, we do not believe that the use of and includes the individual’s name,
Indeed, CHI has adopted HIPAA a standard transaction can create a date of service, type of service, the
standards as the standards for the business relationship or liability that control number it is using to identify the
exchange of administrative information. does not otherwise exist. claim, and other information that will
The complete list of adopted standards 9. Health Care Clearinghouse allow ABC to locate the individual’s
and other details about CHI may be Perspective record. This information, when returned
found at http://www.egov.gov or http:// along with the response, will also
www.whitehouse.gov/omb/egov/gtob/ Health care clearinghouses are enable the health plan to associate this
health_informatics.htm. covered entities under HIPAA, and must new piece of data with the correct
be able to accept and transmit a claim. The ABC Company sends the
8. Health Care Provider vs. Health Plan standard transaction when asked by a
Perspective requested information back to the health
health care provider or health plan for plan, it is associated with M. Smith’s
[If you choose to comment on issues whom they serve as a business associate claim, and the claim continues through
in this section, please include the for those functions. Since both health the adjudication process.
caption ‘‘PROVIDER VS PLAN care providers and health plans have In this example, the health plan wants
PERSPECTIVE’’ at the beginning of your dependencies on the health care the individual’s weight as reported by
comments.] clearinghouses, it is imperative that the the individual (rather than an estimate
Health care providers and health health care clearinghouse industry made by the attendants) expressed in
plans regard claims attachments quite participates actively in the rulemaking pounds, not kilograms. The request will
differently. Health care providers would process, standards review, and contain a code that reflects this exact
prefer to keep attachments to a implementation assessment as well. It request, and the response will return the
minimum and regard requests for would be helpful if health care code with the individual’s weight,
additional claims-related information as clearinghouses were among the first of expressed in pounds.
unnecessarily lengthening the payment all entity types to come into compliance Thus, the standards we are proposing
cycle. Health plans consider the use of with these standards so that testing for any of the named electronic
attachments as a necessary tool to between trading partners—health care attachments types will specify:
ensure appropriate payment decisions, providers and health plans—could be • The administrative information
maintain quality assurance, and executed in a timely fashion. contained in the request and response;
minimize fraud and abuse. What a • The attachment information (also
health care provider may regard as an E. Electronic Health Care Claims
referred to as the additional information
unnecessary and/or onerous request for Attachment Content and Structure
specification) contained in the response;
information may be viewed by the [If you choose to comment on issues • A code set for specifically
requesting health plan as critical to in this section, please include the describing the attachment information;
ensure that payment is being made caption ‘‘ATTACHMENT CONTENT • A code set modifier for adding
according to the provisions of the AND STRUCTURE’’ at the beginning of specificity to the request; and
patient’s policy and benefits, for which your comments.] • The format that will contain all of
the health plan pays. This rule does not As noted, there are two separate this information.
propose to set out requirements for the transactions associated with the The size of the file in the response
appropriateness of requests for electronic claims attachment. One transaction will be impacted by the
additional information. However, the transaction is a health plan’s request for option the health care provider chooses
proposed attachment standards are health care claims attachment for the submission—either text and
designed to reduce miscommunication information, and the other is the health imaged documents or coded data. With
and multiple requests for information by care provider’s response, which imaged documents, the size of the file
providing specificity to both the request includes submission of the attachment within a single response transaction
for information and the response, and information. could become large. The
by establishing specific limits to the Each of these transactions contains implementation guide for the X12 275
content of the attachment. administrative information that response transaction permits up to 64
Health Care Provider vs. Health Plan identifies the individual, date of service, megabytes of data in a single
Implementation: In accordance with and other information that permits the transaction. Industry comment on file
1175(a) of the Act and 45 CFR part 162, health care provider to identify the size is also welcome.
§162.923 and §162.925, health plans appropriate individual and claim, and In sum, the proposed standards are
may not reject any electronic transaction enables the health plan to associate the those that have been under development
simply because it is being conducted as electronic attachment material with the for over eight (8) years by the HL7 ASIG.
a standard transaction. This applies to proper claim. In addition, the Meanwhile, the health care industry
the proposed transactions for electronic attachment request must have an itself has undergone significant change.
health care claims attachment requests unambiguous way to specify the clinical It is, therefore, critical that appropriate
and responses. So, for example, a health or other information needed, and the industry representation reviews and
care provider may direct a health plan attachment response must have an then weighs in on these standards: The
to send any request for additional unambiguous way to label the attachment content, and format, and the
documentation to it or its business information being provided and to transaction’s function. As discussed
associate in standard form, for those convey responses in a consistent, throughout this preamble, we are
attachment types for which a standard predictable manner. soliciting comments from all affected
has been adopted here, and the health Example: ABC Ambulance Company covered entity types (covered health
plan must do so. The health care submits a claim for transporting M. care providers, health plans, health care
provider may also request that the Smith on a certain date. The health plan clearinghouses and Medicare
prescription drug discount card industry, none was appropriate as a 64 megabytes of data. However, after
sponsors) and their business associates transaction standard capable of extensive evaluation, WG9 determined
(practice management vendors, software handling a host of different types of that the existing version of the X12N
vendors, document storage contractors electronic health care claims 275 transaction would have to be
and others) about these proposed attachments. modified, with significant structural
standards. In this paragraph, we changes to accommodate the business
a. Health Care Claims Attachment
reference Medicare prescription drug needs for standardized electronic health
Request Transaction
discount card sponsors as a covered care claim attachments. WG9 also
entity. These organizations are The HISB did not suggest any determined that most of the
considered covered entities until 2006, candidate transactions for use as a supplemental information requested by
when the new Medicare prescription request for additional health care claim health plans was clinical information,
drug program becomes effective. Based information. A review of SDO usually detailed with specific
on the timing of the electronic health transaction inventories and a review of quantitative measurements, laboratory
care claims attachments final rule, the relevant literature by the WG9 identified results, and specific medical reports.
requirements of that final rule may or only one transaction that could be Clinical information of this nature was
may not be relevant to such modified for use as an electronic claims already accommodated by HL7
organizations. attachment request transaction: the messages, but not by anything in the
X12N 277 version 4010 Claim Status X12 repertoire. The X12N 275
F. Alternatives Considered: Candidate Response transaction could satisfy this transaction, when coupled with HL7
Standards for Transaction Types and business need if the implementation message structures, appeared to
Code Sets specifications were modified. The X12N represent the best electronic solution for
[If you choose to comment on issues 277 transaction adopted under HIPAA this purpose. In 1997, ASC X12N
in this section, please include the for claims status inquiries was originally representatives agreed to incorporate the
caption ‘‘ALTERNATIVES created by ASC X12N to provide the use of HL7 standard messages in the
CONSIDERED: CANDIDATE capability to electronically transmit BIN segment of the ASC X12N 275. Over
STANDARDS’’ at the beginning of your information about the (payment) status the past two years, ASC X12N
comments.] of a health care claim (the 277 serves as developed a new implementation guide
a response transaction to the 276 for this use, complemented by the HL7
1. Transactions
inquiry). In order to accommodate the specifications.
History: In the early years of the more extensive business requirements of
HIPAA standards adoption process, the an electronic health care claim 2. Code Sets
ANSI Health Informatics Standards attachment request, a new version of the History: There was virtually no depth
Board (HISB) prepared inventories of implementation specification of the in the pool of available code sets for
transaction standards and code sets for X12N 277–Health Care Claim Status consideration to request or send
HHS so that staff could evaluate the Notification would have been required. information—at least not one individual
available options. Several standards Thus, X12 and HL7 determined that it code set with everything that might be
were selected as potentially viable for was more expedient and practical to needed for electronic health care claims
electronic health care claims create a new transaction standard attachments. Thus, the original
attachments, but no final decision was designed for the specific purpose of candidate for the code set to be used
made at that time, and the proposal was requesting an attachment rather than with attachments was the X12N version
held for additional work. In a 2001 trying to modify one designed as a of health care claims status reason
white paper, HISB again documented response transaction. codes, tied to the X12N 837 claims
the potential transaction standards that transaction and the claims status
could be used for electronic health care b. Health Care Claims Attachment
inquiry and response (X12N 276/277).
claims attachments. The list included Response Transaction
As this option was being evaluated,
the ANSI X12N 275 version 4010 The HISB assessment originally HISB also reviewed another code set
(Additional Information in Support of suggested one standard as a candidate that could potentially serve to identify
the Health Care Claim or Encounter) as for the response to a request for health the additional information needed to
the vehicle to send the electronic care claims attachment information. The process the claim—this was the LOINC
attachment information to the health X12N 275–Patient Information code set.
plan. However, that transaction and a transaction had the closest match in Under HIPAA, the Secretary may
number of other ones considered, were capability and business potential for adopt code sets developed by either
not suitable on their own for a general conveying health care claims private or public entities, including
electronic health care claims attachment attachment information, though it had proprietary code sets. The Act also
standard, as they (the transaction not been adopted as a HIPAA standard allows the Secretary to adopt standards
standards) were overly service specific. for any other purpose. The X12N 275 other than those established by an SDO
For example, the Institute of Electrical transaction was designed to provide if the different standards will reduce
and Electronic Engineers (IEEE) had a individual information to be shared costs for health care providers and
standard (IEEE 1073) for communication among trading partners. When coupled health plans, and other applicable
among bedside devices. Digital Imaging with HL7 message structures, the X12N statutory requirements are met. Both of
and Communication in Medicine 275 appeared to represent the best the code set candidates evaluated for
(DICOM) created a standard for the electronic solution for this purpose inclusion were proprietary code sets
format and transfer of biomedical because of its two key advantages over that had established mechanisms for
images and image-related information. other ASC X12N transactions: (1) The maintenance related updates, were
The American Society for Testing and capability to transmit other standard available without payment of licensing
Materials (ASTM) had created a messages within the transaction; and (2) or use fees, and were already in use by
framework vocabulary for the patient- the ability to transmit large amounts of the medical community.
based record content. While each of information within the BIN segment of Washington Publishing Company is
these standards had its place in the the transaction, which can contain up to the exclusive publisher and copyright
holder of the X12N health care claim status codes were significantly less increase time spent ‘‘pulling and
status reason codes. The Regenstrief definitive and efficient than the LOINC copying medical records’’ and
Institute, Inc. and the LOINC codes for communicating detailed or submitting responses such as ‘‘sent the
Committee are the copyright holders of specific clinical information to whole record,’’ which would increase
the LOINC code set and database. supplement a claim, and made a costs to the health care provider and the
LOINC provides sets of universal recommendation to the Secretary to health plan. There were also concerns
names and identification codes for adopt LOINC for the electronic health about the level of specificity, clarity,
identifying laboratory and clinical test care claims attachment transactions. and redundancy of the codes. In fact, a
results as well as other units of The recommendation was supported cross walk of the claims status codes to
information that are meaningful in through a 1996 ‘‘Proof of Concept’’ the existing standard codes could not be
electronic claims attachments. The study sponsored by CMS, using an early accomplished, and the study showed
LOINC code for a name is unique and version of the X12N 277-Health Care that, in many cases, several claim status
permanent and has no intrinsic Claim Request for Additional reason codes were required at one time
structure except that the last character Information, coupled with the health in order to convey an appropriate level
in the code is a check digit and must care claim status reason codes. Eight of clarity to the request. At the time of
always be transmitted with a hyphen provider/vendor partners and five plans the study, there were 406 local
before the check digit (for example, that were also Medicare contractors
(Medicare) codes being used, and 50
‘‘10154–3’’). The LOINC codes offer a participated in the effort to evaluate the
percent of them could not be mapped to
comprehensive array of coded topics suitability of the X12N 277 and the
the health care claim status reason
designed to support detailed health care claims status codes for
codes.
supplementary information. electronic attachment use (Executive
The Remark and Reason Code Report Medicare Proof of Concept The example in Table 2, Comparison
Committee of X12N maintains the Study: Standard Electronic Requests for of LOINC Codes and Health Care
health care claim status reason codes Additional Medical Review Claim Status Reason Codes for
that are currently used in version 4010 Information). This study identified a Requesting Additional Information,
of the X12N 277 Claims Status response number of barriers related to the use of illustrates the brevity and efficiency
transaction. This transaction provides health care claim status reason codes for associated with using LOINC codes
information about the general status of the purpose of the electronic when compared to health care claim
a claim in response to a request made attachments transactions. Specifically, status reason codes. In this example, the
for such status, using version 4010 of the health care providers did not view health plan is requesting information
the X12N 276 transaction. the codes as sufficiently ‘‘concise’’ in pertaining to treatment, progress notes,
Ultimately, the standards organization providing the request. They predicted and attainment of rehabilitation goals
determined that the health care claims that this lack of precision would for a rehabilitation service.
TABLE 2.—COMPARISON OF LOINC CODES AND HEALTH CARE CLAIM STATUS REASON CODES FOR REQUESTING
ADDITIONAL INFORMATION
Health care claim status reason Health care claim status reason code
LOINC code LOINC code definition code definition
R4: 18658–5:LOI ....... R4 = Requests for additional information R4:310:3F ................................... R4 = Requests for additional information/
and documentation 18658–5 = Psy- documentation; 310 = Progress notes
chiatric Rehabilitation treatment plan, for the 6 months prior to statement
progress notes, and attainment of date; 3F = Rehabilitation facility.
goals LOI = Specifies this is a LOINC
code.
............................................................. R4:436:3F ................................... R4 = Requests for additional information/

documentation; 436 = Short term
goals; 3F = Rehabilitation facility.
............................................................. R4:437:3F ................................... R4 = Requests for additional information/

documentation; 437 = Long term
goals; 3F = Rehabilitation facility.
The LOINC code 18658–5 asks the 3. Implementation Specifications for ability to transmit large amounts of
exact question the plan wants answered Sending and Receiving Additional information within the BIN segment of
with a single code. In contrast, the Health Care Information Within a the transaction. Most of the
health care claim status reason codes Transaction supplemental information requested by
cannot exactly replicate what the plan As described earlier, the HISB health plans is clinical information,
wants answered; the closest match reviewed available transaction options usually detailed with specific
requires three separate requests. In this and recommended that new versions of quantitative measurement, lab results,
example, the use of the existing set of the X12N 277/275 standards be created and specific medical reports. Clinical
reason codes would result in the health and adopted for the transmission of information of this nature could already
care provider sending data that the electronic health care claims attachment be accommodated in HL7 transactions.
health plan did not request and does not information. In particular, the X12N 275 Thus, the BIN segment of the ASC
need because the code for progress notes response transaction had the advantage X12N 275 (response) transaction would
includes an instruction to send 6 of being capable of transmitting other be able to hold all of the attachment
months of information. standards within the transaction and the information requested by the health
plan. In 1997, the NUBC, the NUCC, and BIN segment, and these codes provide first, last, etc. We therefore also propose
the NCVHS were consulted on the data sets of universal names and identifying to adopt the LOINC modifiers as
format to be used in the BIN segment. codes for conveying laboratory and national standards for the electronic
Originally, the NUCC recommended clinical test results as well as other units health care claims attachments.
that a choice between unstructured of information that are important in As we have described earlier, the HL7
ASCII text alone and structured HL7 be health care claims attachments. The specification uses LOINC codes for
given. However, much discussion LOINC process for reviewing and each proposed electronic claims
occurred during the NCVHS meeting updating the database of codes and attachment, and these AIS specify the
itself, and after considering the values also offers sufficient required content and LOINC codes for
comments received, and discussion opportunities for growth and expansion. each electronic attachment. It is,
with health insurance EDI professionals, Therefore, LOINC was determined to therefore, imperative for all segments of
the NCVHS and WG9 determined that be the best match along with the the industry to comment on the
the best options for content structure recommended X12 transaction proposed attachment content, the
were the following: standards and HL7 specifications. attachment criteria and the procedures,
1. HL7 structure—this option would so that the standards can be validated,
require the structure and content of the G. Proposed Standards and any appropriate revisions to those
Additional Information Specification We are proposing certain industry standards made and approved in time
(AIS) to be based entirely on HL7 consensus standards that, when used for the final rule.
defined information for each message. together, provide the functionality The LOINC code set, similar to ICD–
HL7 would define the data content and necessary for the electronic health care 9, CPT–4, HCPCS, CDT and other
structure for each AIS based on existing claims attachment. No other industry proprietary code sets, may be updated
HL7 conventions; standards are in use today for this with new codes as needed to reflect new
2. HL7 plus ASCII text structured— purpose. The proposed standards are technology, services, and procedures.
this option would allow, in addition to fully compatible with the other ASC Similar to other code sets, maintenance
the HL7 structure, additional X12 and HL7 standards and can be updates of the LOINC code set are
specifically formatted text information translated to and from various systems permissible and do not require
(defined lengths, etc.). This would limit using software programs (commonly regulatory action, though the formal
the amount and type of additional referred to as ‘‘translators’’ and procedures of the code set maintainer
information that could be submitted; or ‘‘interface engines’’) that are must be followed for requesting, adding
3. HL7 plus ASCII text unstructured— increasingly used by industries using and communicating new codes to each
this option would allow, in addition to ASC X12 transactions and HL7 code set. The addition of new codes to
the HL7 information, any additional text messages. the LOINC code set is considered a
information. This rule proposes the following for routine code set maintenance activity
The NCVHS Subcommittee on adoption as national standards for and does not require rulemaking
Standards and Security held hearings on electronic health care claims because, in part, additions (and
this specific issue on June 15, 1998 in attachments: deletions) do not change the format or
Washington DC. Representatives from field size of the codes. Such
1. Code Set
ASC X12N, HL7, NUBC, NUCC, HHS, maintenance simply allows the addition
providers, a translator firm, and a health The industry organizations that or deletion of codes to accommodate
care clearinghouse spoke to the developed the electronic claims clinical advances and industry needs.
advantages and disadvantages of each of attachment standards proposed the Modification, on the other hand,
the options. After discussion, the adoption of LOINC as the code set for involves actual format changes to some
NCVHS Subcommittee voted to representing the specific elements of or all of the codes, or the code set in its
recommend to the full committee attachment information. In 1998, entirety, such as converting a numeric
Option 1, which would require HL7 NCVHS held several days of hearings on code set to an alphanumeric code set.
messages within the BIN segment of the electronic health care claims Such a change would likely require
ASC X12N 275 version 4020— attachments, including presentations on significant business and system changes
Additional Information to Support a the status of a pilot for the request and programming. Therefore, use of a
Health Care Claim or Encounter transaction, the types of attachments modified code set would require
implementation guide. This approach being requested by health plans, and the rulemaking to allow the industry time to
would accommodate a broad spectrum use of the LOINC code set for evaluate the impact and provide
of possible information since the HL7 describing and/or itemizing the feedback to the Department, the code set
standard permits unstructured ASCII information being requested, and the maintainers, and other relevant parties
text within the body of an HL7 information being submitted in response with authority.
structure. The HL7 standard supports to that request. Based on the testimony, To date, we have no information to
the additional information NCVHS recommended that the LOINC indicate that LOINC is being evaluated
specifications that represent the specific code set be adopted to support for any kind of modification and
supplementary information being electronic health care claims therefore we are comfortable
submitted in the form of an attachment. attachments. We support the recommending its adoption for use with
Thus, the AIS, formatted in accordance recommendation, and have included the electronic health care claims
with the overarching HL7 adoption of LOINC codes as a part of attachments. The most common updates
Implementation Guide, represents the this proposed rule. HL7 has created to LOINC will likely be in the
data to be transmitted in the BIN companion LOINC modifiers that categories of laboratory results, clinical
segment of the X12N 275 transaction. would add further specificity to the reports, and medications, as new
The LOINC codes offer a LOINC code itself. These modifiers diagnostic studies, clinical reports,
comprehensive array of coded topics refine the requests in terms of time expansion of lab technology, new tests
that readily support detailed frame; for example, on, before, or during and new drug regimens are adopted by
supplementary information that can be a particular encounter, or in terms of the industry. The proposed HL7
transmitted by HL7 messages within the item modifiers, such as abnormal, worst, attachment specifications for laboratory
results, clinical reports and medications Additional Information) transaction to requesting medication supplemental
allow for the use of new LOINC codes convey the request for the electronic information are contained in this guide.
in the response, once these become claim attachment. It would identify the
3. Electronic Health Care Claims
available in the LOINC code set and claim and related data needed. This
Attachment Response Transaction
are needed for communication between transaction would serve as an
HIPAA trading partners. ‘‘electronic envelope,’’ conveying the We are proposing to adopt the ASC
With respect to the attachment data LOINC code or codes appropriate to X12N 004050X151 (ASC X12N 275—
that can be requested, also known as the that electronic attachment request. Only Additional Information to Support a
‘‘questions’’ or attachment components, LOINC codes specified in the HL7 AIS Health Care Claim or Encounter) as the
the AISs for ambulance, emergency booklets and LOINC code tables for the response transaction to convey the
department, medications, and particular electronic attachment can be claim identification and related data,
rehabilitation contain a finite list of requested. Medications, laboratory such as individual name, provider
LOINC codes that may be used. New results, and clinical reports may use any name, date and type of service, that are
questions, and therefore potential new of the relevant codes in the LOINC needed to match the information to the
LOINC codes for the current AIS that code set. The responding transaction original claim. The claim identification
are proposed as a result of the public (the X12N 275) would echo the and related data are conveyed in the
comment before publication of the final requester’s LOINC request codes, and BIN segment of the transaction that
rule would need to go through the HL7 provide the data associated with those serves as an ‘‘electronic envelope.’’ This
ballot process; if approved in time, the LOINC codes, in either the human or envelope also conveys the HL7 message
new questions, in the form of LOINC computer decision variants. that carries the supplementary
codes, could be incorporated in the AIS In part 162, we would specify the electronic health care claims attachment
adopted in the final rule. Any LOINC ASC X12N Implementation Guide data in the form of an AIS.
question code additions or changes to 004050X150 (ASC X12N 277—Health Information conveyed by the HL7
the specifications made after Care Claim Request for Additional message would be the specific AIS
publication of the final rule would Information) as the standard for provided in response to the LOINC
require rulemaking, as do changes to requesting electronic health care claims code or codes contained in the request,
other standards. New LOINC codes attachment information. Note that or as an unsolicited (but pre-arranged)
may be requested through Regenstrief, LOINC codes being used to request electronic attachment submission. Each
by following the procedures outlined in specific information must be those electronic attachment type is identified
the LOINC manual, Appendix D. specified in the appropriate AIS as by a unique LOINC code that indicates
Submissions may be made via e-mail or follows: its name and appears in the header of
regular mail, and the RELMA tool offers a. CDAR1AIS0001R021 Additional the message for identification purposes;
use of an ACCESS database to ensure Information Specification 0001: for example, psychiatric rehabilitation
the completeness of the request.
Ambulance Service Attachment. The has its own unique LOINC code of
Commenters are encouraged to become
instructions and LOINC code tables for 18594–2. Other LOINC codes used in
familiar with the RELMA tool, the
requesting ambulance supplemental the body of the message will specify the
LOINC database and the LOINC
information are contained in this guide. specific information related to that
manual.
We specifically do not name a code b. CDAR1AIS0002R021 Additional service that is desired (for example, the
set for medications or drugs for this Information Specification 0002: psychiatric rehabilitation plan). The
proposed rule. NDC was repealed as the Emergency Department Attachment. individual booklets for each HL7 AIS
code set for non-retail pharmacy drugs The instructions and LOINC codes for contain the instructions and LOINC
and biologics under the Transactions requesting emergency department code tables that define all of the data
Rule, and no other single code set for supplemental information are contained content that may be used in that
drugs has been adopted for non-retail in this guide. particular electronic attachment.
pharmacy transactions. The HL7 AIS for c. CDAR1AIS0003R021 Additional The LOINC code set provides a set
medications allows requests for current Information Specifications 0003: of subject modifier codes that are
medications, medications administered Rehabilitation Services Attachment. The categorical; that is, an identifier code
during treatment, and discharge instructions and LOINC code tables for can apply to a group of related reports.
medications. The AIS is written such requesting rehabilitation services For example, Clinical reports can be
that it functions with any narrative text, supplemental information are contained identified by the type of equipment
codes or coding system that are agreed in this guide. used (for example, CAT scan report); the
to between trading partners; it does not d. CDAR1AIS0004R021 Additional body part examined (report of x-ray of
require any single code set to be used. Information Specifications 0004: left wrist), the subdivision of the
The AIS has a section devoted to special Clinical Reports Attachment. The laboratory performing the analysis
considerations for the drug codes and instructions and LOINC code tables for (microbiology), or a challenge to the
reporting requirements that will work in requesting clinical reports supplemental system (cardiac stress test). Different
both human and computer decision information are contained in this guide. combinations of these facts can produce
variants. Industry representatives e. CDAR1AIS0005R021 Additional information relevant to a clinical reports
should read this AIS in order to provide Information Specifications 0005: AIS. Therefore, it is important that the
feedback to HHS and the SDOs Laboratory Results Attachment. The request transaction, based upon the ASC
regarding this approach to medication instructions and partial list of LOINC X12N 277 version 004050x150 being
documentation. codes for requesting laboratory results submitted, use the LOINC Report
supplemental information are contained Subject Identifier Code(s) that most
2. Electronic Health Care Claims in this guide. clearly represents the attachment
Attachment Request Transaction f. CDAR1AIS0006R021 Additional information needed. The LOINC
We are proposing to adopt the ASC Information Specifications 0006: Report Subject Modifier Codes can be
X12N 004050X150 (ASC X12N 277— Medications Attachment. The found in the LOINC Committee
Health Care Claim Request for instructions and LOINC codes for publication.
In part 162, we would specify the elements include information on plan X12 Implementation Guides describe
ASC X12N Implementation Guide progress, signatures, attending how the LOINC codes and LOINC
004050X151 (ASC X12N 275— physicians, symptoms, and levels of modifiers are to be used, and how the
Additional Information to Support a individual participation. segments within the BIN segment of the
Health Care Claim or Encounter and the d. CDAR1AIS0004R021, Additional response transaction are used to carry
HL7 CDAR1AIS0000RO21 HL7— Information Specification 0004: Clinical the actual attachment information.
Additional Information Specification Reports Attachment, Release 2.1, based Individual LOINC codes and LOINC
Implementation Guide, and HL7— on HL7 CDA Release 1.0. The Clinical modifiers are defined for each
Clinical Document Architecture Reports AIS allows for the electronic component of the electronic attachment,
Framework Release 1.0) as the standards transmission of a wide variety of specific to each discipline. The
for conveying electronic health care clinical reports, such as modifiers permit the request to be
claim attachments, and we would electrocardiograms and radiology limited by date, time, number of
specify the following six specifications reports. Examples of data elements repetitions, and other factors. Each AIS
as the standards for the electronic health included in this AIS are specimen includes tables of the LOINC codes
care claims attachments: source, reason for study, and needed to request the attachment data
a. CDAR1AIS0001RO21, Additional observation values. The instructions and specific to each claim type. However, a
Information Specification 0001: LOINC codes for transmitting clinical request for Emergency Department
Ambulance Service Attachment, Release reports by an AIS cover a wide variety information may include a request for
2.1, based on HL7 CDA Release 1.0. The of functional topics. These include, but data on laboratory results or diagnostic
Ambulance AIS contains data elements are not limited to, discharge summaries, studies either as part of a full
used to describe ambulance services. operative notes, history and physicals, Emergency Department attachment or as
These include body weight, transport clinic visits, other assessments, and all a Laboratory Results attachment or a
distance, and the reason for the types of diagnostic procedures Clinical Reports attachment. In other
ambulance trip. including laboratory studies. words, it is possible that an electronic
b. CDAR1AIS0002RO21, Additional e. CDAR1AIS0005R021, Additional attachment request for one claim may
Information Specification 0002: Information Specification 0005: require multiple attachment types. The
Emergency Department Attachment, Laboratory Results Attachment, Release Emergency Department attachment
Release 2.1, based on HL7 CDA Release 2.1, based on HL7 CDA Release 1.0. The specification defines all of the LOINC
1.0. The Emergency Department AIS is Laboratory Results AIS gives health care codes necessary to electronically request
used to provide supporting providers the ability to report a wide attachment data specific to treatment in
documentation when an emergency variety of laboratory results. Data an emergency department. In fact, there
department visit is reported. Data elements include individual identifiers, are three codes that represent an explicit
elements include assessment results, reasons for the study, actual laboratory request for the complete set of data
medications provided, and the chief results, and abnormality indicators. components relevant to emergency
complaint reported. This AIS is derived f. CDAR1AIS0006R021, Additional department events, inclusive of
in part from the document Data Information Specification 0006: laboratory results and diagnostic
Elements for Emergency Department Medications Attachment. Release 2.1, studies. Alternatively, the health plan
Systems, Release 1.0 (DEEDS), based on HL7 CDA Release 1.0. The may request only one piece of
published by the National Center for information for a specific attachment
Medications AIS allows health care
Injury Prevention and Control, Centers type. For example, it may request only
providers to report on the medication an
for Disease Control and Prevention. The the associated lab results for the ER
individual is currently taking, or was
DEEDS document provides uniform visit. When only lab results or
given during a course of treatment, or
specifications for data elements that diagnostic studies are requested for an
was provided upon discharge. Data
may be used for EDI transactions. The emergency department encounter, the
elements include individual identifiers,
emergency department AIS includes a results and studies are to be reported as
medications provided, and units of the
subset of those data elements and adds defined in the Laboratory AIS, but the
medication.
additional elements on to meet the information is to be sent in the response
New AIS addressing durable medical
business needs associated with this to the specific request related to the
equipment, home health, and
attachment. Because this AIS only uses services provided in the emergency
periodontal charting are currently being
a portion of the DEEDS data element department; the claim ID will be used to
document, DEEDS would not be developed by HL7. We solicit comments
regarding which other attachments most match up the data.
adopted as a code set for this HIPAA As another example, using the
impact the health care industry with
transaction. Rehabilitation AIS, the LOINC codes
c. CDAR1AIS0003R021, Additional respect to the exchange of clinical and
for rehabilitation services include some
Information Specification 0003: administrative information, specifically
codes that can be used to request or
Rehabilitation Services Attachment, for the purpose of claims adjudication.
send information about medications the
Release 2.1, based on HL7 CDA Release 4. Examples of How Electronic Health individual reported taking as part of the
1.0. The Rehabilitation Services AIS Care Claims Attachments Could Be rehabilitation treatment plan. The
provides information on rehabilitation Implemented specifications for sending medications
care plans associated with nine are described in section two of the AIS
disciplines: Alcohol/Substance Abuse a. Use of the Proposed Transactions,
for Medications. The sender will use the
Rehabilitation, Cardiac Rehabilitation, Specifications, and Codes for Electronic
instructions in the Medications AIS for
Medical Social Services, Occupational Health Care Claims Attachments
sending medication information related
Therapy, Physical Therapy, Psychiatric An X12N 277 request for claims to the rehabilitation plan claim and the
Rehabilitation, Respiratory Therapy, attachments may be used to required additional documentation/
Speech Therapy, and Skilled Nursing. electronically request one or more attachment.
This AIS is not intended to attachment types, and the X12N 275 Again, it is critical for the industry to
accommodate requests for attachments response can be used to transport one or evaluate the HL7 AISs, the X12
related to Home Health claims. Data more electronic attachment types. The Implementation Guides and the LOINC
code set to fully evaluate and most appropriate for a particular setting volume of activity and determine that one or
understand their use and the or entity type. These scenarios are not two attachments encompass a
implications on technical systems and the only options for implementation and disproportionate percentage of all their
business operations. compliance; rather, they were crafted by attachment volume, they would prioritize the
HL7 in an effort to help the industry accommodation of those one or two
b. White Paper from HL7 understand how electronic health care attachments as structured data to facilitate
A white paper entitled ‘‘HIPAA and auto-adjudication.
claims attachments could be
All following scenarios represent the
Claims Attachments: Preparing for implemented. The descriptions and pros processing that takes place either after a
Regulation’’ was written and published and cons for each scenario were taken payer has requested additional
in August 2003 by the ASIG at HL7. in their entirety from the white paper, documentation from the provider or when
This white paper, reproduced in part in and therefore the term ‘‘payer’’ instead the provider has elected to submit additional
this preamble with specific written of ‘‘health plan’’ is used throughout this information in the same transmission as the
permission from HL7, provides sample section. These two terms have the same initial claim. The payer and provider
scenarios depicting how health care meaning for purposes of this discussion. scenarios are not dependent upon each other.
providers and health plans could Any comments on the white paper may Each payer and provider can choose a path
comply with the proposed standards for be submitted to the ASIG, through the most suitable to the situation independent of
electronic attachment transactions. The HL7 Web site. the means used by the others with whom the
entire white paper is also available at no The text for the HL7 white paper payer and provider exchange standardized
charge on the HL7 Web site, http:// begins here: electronic transactions.
www.HL7.org. Provider Compliance:
Providers and payers have the latitude to
The document is included here to Provider Scenario 1: A provider keeps
choose a path that suits their own balance of
patient data in paper records. The provider’s
highlight some of the possible low/high impact vs. low/high business
benefit. In general, the scenarios are listed billing application is adapted to accept
approaches to implementation, and to scanned images. Once the appropriate
depict how electronic health care claims from low impact/low business benefit to high
impact/high business benefit. Both payers attachments documents are scanned from the
attachments requests and responses paper medical record, the billing application
and providers also have the latitude to
could work between health plans and analyze their own business needs and associates that scanned image with a claim
health care providers. The scenarios prioritize the accommodation for each and includes the scanned image as an
may be useful to covered entities in individual attachment. For example, if either attachment in submission to the payer as
determining which path may be the payers or providers review their current needed.
Advantages—This scenario requires member to scan the documents that contain assign the new task of scanning in
minimal changes to the billing application. the attachments data. Since the required attachments data to staff members.
Based on feedback from the healthcare attachments data may exist on forms that also Provider Scenario 2: The provider installs
industry, this accommodation was include other, unnecessary data, the staff a conversion utility in the billing or practice
specifically included in the specification as member may, for privacy reasons, also have management software to translate
an interim step for providers who plan to to take whatever steps are necessary to attachments data from its current format into
eventually adopt one of the other scenarios a fully formatted attachment with structured
ensure the privacy of Protected Health
that result in sending attachments as data. The provider is then able to key the
Information under HIPAA.
structured data, but needed an expedient attachment data into the conversion utility.
alternative as an interim step. Likely changes from status quo—The The utility creates the attachment and
Disadvantages—This scenario does not provider’s billing vendor would have to delivers it to the billing application. The
provide the payer with the structured data accommodate the new X12N 277 and 275 billing application then associates the
necessary to auto-adjudicate the claim, thus transaction sets and would have to enable the formatted attachment with a claim and
negating much of the advantage of electronic attachment of a scanned image to the 275 includes it in submission to the payer as
attachments. This scenario requires a staff transaction set. The provider would have to needed.
EP23SE05.051</GPH>
Advantages—This scenario provides the application into the provider’s information install, and support the new conversion
payer with the structured data necessary to systems environment. Attachments data are utility. The provider’s billing vendor would
auto-adjudicate the claim. It also requires manually typed into the conversion utility, have to accommodate the new request for
minimal changes to the billing application. which is an additional workflow step. Since attachment and the response (with
This scenario also provides a ‘‘bridge’’ this scenario requires an additional workflow attachment) and join the attachment from the
between the EMR scenario described in step, the provider does not have an conversion utility with the claim.
Scenario 4 and the strictly text/image model automated solution for submitting
Provider Scenario 3: The provider’s billing
in Scenario 1. Although this scenario unsolicited attachments with the initial
introduces an additional workflow step, it claim. Furthermore, there is an increased application is adapted to allow attachments
also allows for the elimination of other opportunity for human error, due to the information to be keyed directly into the
workflow steps such as copying paper files requirement for manual keying of billing application. The billing application
and dealing with the U.S. mail process. information. then formats the attachment information as
Disadvantages—This scenario requires the Likely changes from status quo—The structured data and includes it in submission
addition of a new conversion utility provider would have to select, purchase, to the payer as needed.
Advantages—This scenario provides the requires an additional workflow step, the data attachment itself. The provider would
payer with the structured data necessary to provider does not have an automated have to reassign staff to the new task of
auto-adjudicate the claim. Only the billing solution for submitting unsolicited keying in attachment data, versus their
application needs to be upgraded. This attachments with the initial claim. previous task of copying and mailing records
scenario also provides a ‘‘bridge’’ between Furthermore, there is an increased manually.
the EMR scenario described in Scenario 4 opportunity for human error, due to the
and the strictly text/image model in Scenario requirement for manual keying of Provider Scenario 4: The provider’s
1. Although this scenario introduces an information. Electronic Medical Record (EMR) or clinical
additional workflow step, it also allows for Likely changes from status quo—The information system provides a fully
the elimination of other workflow steps such provider’s billing vendor would have to formatted attachment with the appropriate
as copying paper files and dealing with the enable the provider’s billing application to attachment information to the billing
U.S. mail process. accept attachment data that have been keyed application. The billing application then
Disadvantages—This scenario requires the manually, and would have to accommodate associates the formatted attachment and
attachments data to be manually typed into the new request for an attachment and includes it in submission to the payer as
the billing application, which is an sending the response with the attachment needed.
additional workflow step. Since this scenario data, as well as the creation of the structured
EP23se05.053</GPH>
EP23SE05.052</GPH>
Advantages—This scenario provides the transmit them to payers. Various provider convert the HL7 message into a CDA
payer with the structured data necessary to systems would have to produce structured document. In a few cases, the provider may
auto-adjudicate the claim. attachments in CDA format and route them choose to use desktop productivity
Disadvantages—This scenario requires to the billing system. Examples of potential applications to accept input.
capabilities for data exchange to be present source systems include the electronic Payer Options
in the provider’s billing and one or more medical record, laboratory, radiology (for Payer Scenario 1: If the attachment is sent
EMR/clinical applications. reports), rehabilitation, and general as an image instead of structured data using
Likely changes from status quo—The transcription. Where the source system CDA, manual adjudication may be done by
provider’s billing application would have to already produces HL7 version 2 messages, viewing the image using a Web browser or
accept attachments as XML documents and the provider may use an integration broker to image viewer.
Advantages—This option represents the manual requests and responses, and Payer Scenario 2: If the payer already uses
least organizational change for the payer. minimize the number of ‘‘lost records.’’ a conversion utility to translate X12N
There may be savings opportunities based on Disadvantages—None of the benefits of transaction sets, and that conversion utility is
the reduction in mailed requests and the auto-adjudication are realized. capable of also translating CDA based
manual tracking systems used to associate Changes to the Status Quo—Elements of attachments, the claim may be auto-
hard copy requests, records, and the related the payer’s application suite are modified to adjudicated. Exceptional claims may be
claims. It is possible that this option would associate the CDA (XML) based attachment manually adjudicated and attachments
reduce time delays associated with the for human viewing via a browser. viewed using a Web browser.
EP23SE05.055</GPH>
EP23SE05.054</GPH>
Advantages—A conversion utility may be Disadvantages—Additional responsibility transaction sets, and that conversion utility is
more flexible and may more readily is placed on the conversion utility. This may not capable of also translating CDA based
accommodate the new tasks for parsing XML or may not be a disadvantage. attachments, a second conversion utility may
based attachments than the payer’s main Changes to the Status Quo—Existing be used and the claim may be auto-
conversion utilities have to be either
system. This option provides the potential to adjudicated. Exceptional claims may be
reconfigured or modified to parse CDA (XML
maximize auto-adjudication and minimize based) attachments. manually adjudicated and attachments
administrative costs. Payer Scenario 3: If the payer already uses viewed using a Web browser.
a conversion utility to translate X12N
EP23se05.056</GPH>
Advantages—Existing components attachment and its X12N transaction set. This maintain the association between the
continue to function with little or no may add significant complexity to the flow attachment and its X12N transaction set.
modification. Auto-adjudication may still be of electronic transaction sets. Payer Scenario 4: If the payer is capable of
used to its potential. Changes to the Status Quo—One or more parsing both X12N 275 transaction sets and
Disadvantages—This adds one or more utilities are added to the payer’s application CDA based attachments, the claim may be
utilities to split the attachment from its X12N auto-adjudicated. Only exceptional claims
suite to split the attachment from its X12N
transaction set, parse the attachment, and are manually adjudicated. When necessary,
transaction set, parse the attachment, and
maintain the association between the attachments are viewed using a Web browser.
EP23se05.058</GPH>
EP23se05.057</GPH>
Advantages—This scenario is the best case specifications also represented claim with the requirements set out in
and has the best potential to maximize auto- types that were subjected to additional §162.930, adopted by the Transactions
adjudication and minimize administrative documentation requests in their own Rule.
costs.
right, so the six together were a practical
Disadvantages—This may involve the most 1. Additional Information Specification
significant changes to the primary fit. Thus, for example, if a health plan
(AIS) Uses: Attachment Types That May
information systems used for processing needs additional information about an
Be Used for Any Service
claims. ambulance service, and needs
Changes to the Status Quo—Most large information about the medications an The proposed rule would require that
primary management information systems individual is taking in order to attachment requests, responses, and the
are legacy based mainframe systems. These adjudicate the ambulance claim, both AIS be used in the following situations,
systems would need to integrate with XML the ambulance and medication AIS when the transaction is being conducted
aware browsers to view XSL ‘‘rendered’’ electronically:
would be used and sent within the same
attachment data. a. Clinical Reports
X12N transaction.
The text for the HL7 white paper ends Used when the health plan is
here. Covered Health Care Providers requesting, or the health care provider is
We would require covered health care supplying, clinical report information
H. Requirements (Health Plans, Covered needed to support the adjudication of a
providers to be prepared to receive and
Health Care Providers and Health Care claim for any service. The request may
send the standards specified in
Clearinghouses) cover a wide variety of questions that
§ 162.1915 and § 162.1925 for the
Health plans would be required to be specific electronic health care claims require information from clinical
prepared to receive and send only the attachment transactions, if they choose reports, such as surgical and diagnostic
standards specified in § 162.1915 and to receive and send requests and procedures and discharge summaries.
§ 162.1925 for the identified responses electronically for any of the b. Laboratory Results
transactions. No other electronic six proposed attachments. No other Used when the health plan is
transaction format or content would be electronic formats would be permitted requesting, or the health care provider is
permitted for the identified transactions. for these specific business purposes. For supplying, information on laboratory
We intend for covered entities to use the information required for other business results needed to support the
standard transactions and the approved purposes, the standards proposed here adjudication of a claim for any service.
attachment specifications as they apply would not limit the type and format of The request may cover the entire set of
to the six named attachment types. electronic or paper transaction could be laboratory tests, from allergy to
The use of the standard electronic used. Health care providers generally toxicology.
health care claims attachments would have the option of using paper as their c. Medications
not preclude the health plan from using regular mode of communication. Any Used when the health plan is
other processes or procedures to verify information requested after the claims requesting, or the health care provider is
the information reported in the adjudication process, such as for post- supplying, information on medication
attachment documentation. adjudication medical review or quality information needed to support the
Under the proposed rule, health plans assurance review, would not be subject adjudication of a claim for any service.
may continue to use manual processes to the standards proposed here. In either The request may cover medications
(such as paper forms, letters, faxes, etc.) administered during a service,
case, covered health care providers
to request additional documentation medications sent home with the
would continue to have the option of
from a health care provider, even for the individual, or medications currently
using electronic or manual means of
attachment types listed in this proposal. being taken by the individual.
conducting business, including
However, whenever such a request is responding to a request for attachment 2. Additional Information Specification
made electronically, it must be made information electronically or on paper. (AIS) Uses: Attachment Types for
using the standard. Furthermore, if the However, if they choose to respond Specific Services
health care provider asks that the electronically to an attachment request a. Rehabilitation Services
transaction be sent using the standard, for which a standard has been adopted, Used when the health plan is
the health plan must comply. that standard would have to be used. requesting, or the health care provider is
As stated earlier, it is possible that Any electronic attachments covered supplying, rehabilitation services
multiple AIS apply to a particular by the rule and that accompany a new information needed to support the
electronic claim attachment request. claim would have to be submitted based adjudication of a claim that includes
The clinical reports, medications, and on an advanced instruction from the one or more of the nine disciplines
laboratory results AIS could be used to receiving health plan. These designated for rehabilitation services
request additional information about ‘‘unsolicited’’ electronic attachments (for example, occupational therapy,
any service in a particular claim. should not be sent without prior cardiac rehabilitation, or substance
However, the ambulance, emergency agreement or understanding between abuse therapy).
department, and rehabilitation services trading partners. b. Ambulance Services
AIS can only be used to request Used when the health plan is
information about the specific type of Health Care Clearinghouses
requesting, or the health care provider is
services to which they refer. When the Health care clearinghouses would be supplying, information needed to
ASIG developed the first set of required to be prepared to receive and support the adjudication of a claim that
attachment types, three were for specific send only the standards specified in includes ambulance services.
types of services—ambulance, §162.1915 and §162.1925 for the c. Emergency Department
emergency department, and specific electronic health care claims Used when the health plan is
rehabilitation. Since those services often attachment transactions, or to translate requesting, or the health care provider is
necessitated tests and reports, the proprietary information from their supplying, information needed to
supporting attachment specifications— clients into standard format for re- support the adjudication of a claim that
laboratory results, clinical reports and transmission. Health care includes emergency department
medications—were created. These latter clearinghouses must already comply services.
3. Maximum Data Set constitutes a ‘‘modification of the code attachments. In 1993, WEDI estimated
Each AIS is considered to include the set.’’ Use of a modified code set can that 400 or more specific attachments
maximum data set for each of the named only be required through further were in use to support health care
electronic attachment types. We propose rulemaking to expressly adopt those business needs. Comments from the
to prohibit health plans from asking for modified code sets in place of the industry are needed to validate and/or
additional data beyond those that are existing standard. update this figure, as it is over 10 years
The implementation specifications, as old, and represents many different types
specified in the AIS for that service.
expressed in implementation guides for of attachments which are not all
Four of the attachment specifications
the various ASC X12N transactions and required solely for health care claims
(ambulance services, emergency
HL7 messages as well as the additional adjudication. For example, the original
department, medications, and
information specifications and the list of attachments included such
rehabilitation services) have a finite set
LOINC Modifier Codes, may all be documentation types as certification for
of LOINC codes that can be used to ask
obtained at no charge from the sterilization and hysterectomy, dental
the questions (request the information) Washington Publishing Company site at
for those services. The specifications for services, eligibility, worker’s
the following Internet address: http:// compensation verification and the like.
Laboratory Results and Clinical Reports www.wpc-edi.com/.
do not contain pre-defined lists of codes We do not believe that there are 400
Users without access to the Internet different health care claims attachment
because clinical developments in those may purchase the X12N implementation
two areas necessitate the ability to use types that would in fact be appropriate
guides from the Washington Publishing for electronic health care claims
and request information about new tests Company directly: Washington
and reports. Any of the laboratory and attachment requirements. The industry
Publishing Company, PMB 161, 5284 should identify the relevant attachment
clinical reports codes in the LOINC Randolph Road, Rockville, MD, 20852;
database could be used for these types and collaborate to assign priority
telephone 301–949–9740; FAX: 301– to each one, so that new electronic
requests and responses. 949–9742.
The proposed AIS documents were attachment specifications that are
HL7 maintains the XML-based appropriate to the business needs of the
drafted several years ago when business Clinical Document Architecture Release
practices related to health care claims health care industry can be developed.
1.0 and the AISs, and information can
attachments were likely different than be obtained at no charge at the HL7 Web A. Modifications to Standards
they are today. Therefore, the electronic site: http://www.HL7.org. Users without
health care claims attachment data In §162.910, parameters are outlined
access to the Internet may obtain HL7 for requesting and making modifications
elements, questions, and the cardinality documents directly from the HL7
of these elements must be validated for to the standards. The statute provides
organization, c/o Health Level Seven, that the Secretary of HHS may not
each specification. It is imperative that Inc., 3300 Washtenaw Avenue, Suite
each AIS be thoroughly reviewed by modify any standard, including the
227, Ann Arbor, MI 48104, or 734–677– electronic attachment standards, more
covered entities to ensure that the 7777.
proposed data set meets current and frequently than once a year and must
The LOINC database and the
projected future business needs. Thus, permit at least 180 days for
publication LOINC Modifier Codes can
we ask that during the comment period, implementation of an adopted
be obtained at no charge from the
health plans and health care providers modification to a standard by all
Regenstrief Institute site at the following
engage fully in the process of evaluating affected entities before compliance with
Internet address: http://
this maximum data set and the required, the modified standard may be required.
www.regenstrief.org/loinc/loinc.htm.
situational, and optional elements, and The Secretary may, however, adopt a
Users without access to the Internet may
provide us with comments on these modification at any time during the first
obtain the LOINC database and the
issues. year after the standard or
LOINC modifier codes from the
implementation specification is initially
I. Specific Documents and Sources Regenstrief Institute, c/o LOINC, 1050
adopted, if the Secretary determines that
West Wishard Blvd., Indianapolis, IN
All code sources that are developed the modification is necessary to permit
46202, telephone 317–630–7433.
outside of the X12 standard setting The full set of the Data Elements for compliance with the standard.
process, such as ZIP codes, which are Emergency Department Systems, The addition or deletion of codes in
maintained by the United States Postal Release 1.0 (DEEDS) is published by the a code set for the purpose of enhancing
Service, are referred to as external code National Centers for Injury Prevention the electronic attachment’s
sets. These code sets are maintained and Control, Centers for Disease Control communication capabilities is
independent of any HIPAA specific and Prevention. The Internet address is considered maintenance, because such
requirements, and no rulemaking is http://www.cdc.gov/ncipc/pub-res/ actions do not constitute format or field
required when changes are made to deedspage.htm. length changes to the codes or the code
them. The external code sets are listed set itself. HIPAA expressly permits the
in section C of the appropriate ASC III. Modifications to Standards and routine maintenance, testing,
X12N implementation guide. All of the New Electronic Attachments enhancements, and expansion of a code
code sources listed in the ASC X12N [If you choose to comment on issues set. We have stated throughout the
Implementation Guides have in this section, please include the preamble, that if the codes or code set
mechanisms for modifying their codes. caption ‘‘MODIFICATIONS TO were changed structurally—for example,
The contact posted on the code source STANDARDS AND NEW changing from a numeric format to an
list can provide detailed information ATTACHMENTS’’ at the beginning of alphanumeric format, this would be
regarding the process and timing for your comments.] considered an actual modification of the
updating its codes. If the format of a To encourage innovation and promote code set that would require system
code set that has been adopted as a development, we propose to adopt a changes. Use of such a modified code
HIPAA code set (HCPCS, CPT, ICD–9 process that will facilitate the set could not be required, and would
etc.) is changed, for example, from alpha development and future use of not be permitted, without a regulatory
to alpha numeric, then the change electronic health care claims change.
There are mechanisms in place for proposed additional information comments we receive by the date and
LOINC to add new codes on a regular specifications, the Secretary may choose time specified in the ‘‘DATES’’ section of
basis to reflect developments in the to incorporate them in a future proposed this preamble, and, when we proceed
industry, just as occurs with ICD–9, rule and subsequently may adopt them with a subsequent document, we will
CPT–4, and HCPCS, among others. New as HIPAA standards. respond to the comments in the
codes may be used in an electronic preamble to that document.
C. Use of Proposed and New Electronic
health care claims attachment without a
Attachment Types Before Formal VI. Regulatory Impact Analysis
change to the rule, if use of a new code
Approval and Adoption [If you choose to comment on issues
is specifically permitted by the AIS, and
the use complies with the associated Due to the need to complete this in this section, please include the
ASC X12N Implementation Guides and rulemaking, together with the delayed caption ‘‘IMPACT ANALYSIS’’ at the
HL7 AISs. For example, new LOINC compliance dates provided for by beginning of your comments.]
codes for new types of laboratory results statute, the final rule will not be
A. Overall Impact
and clinical reports will be added to implemented for several years. There
LOINC based on medical are no Federal prohibitions on the use We have examined the impacts of this
developments. Use of such new codes is of the proposed X12 standard rule as required by Executive Order
permitted by the AIS for laboratory transactions or HL7 AIS between now 12866 (September 1993, Regulatory
results, clinical reports and medications and the time compliance with the final Planning and Review), as amended by
in both the request and the response standards is required. Even after the Executive Order 13258, and the
transactions. final rule is published, and compliance Regulatory Flexibility Act (RFA) (Pub.
Requests for new LOINC codes are to is required, if the Secretary has not L. 96–354), section 1102(b) of the Social
be addressed to the Regenstrief Institute named a standard for a particular type Security Act, the Unfunded Mandates
for Health Care, c/o LOINC Committee, of electronic claims attachment, covered Reform Act of 1995 (Pub. L. 104–4), and
1050 West Wishard Blvd, Indianapolis, entities are still free to use that Executive Order 13132.
IN 46202, or electronically, in attachment type on a voluntary basis for The impact analysis in the
accordance with the instructions in any business purpose they deem Transactions Rule assessed the expected
Appendix D of the LOINC users guide, appropriate. costs and benefits associated with the
to the Regenstrief Web site at http:// For example, if the DME attachment Administrative Simplification
www.regenstrief.org. and will be specification is finalized, balloted, and regulations (related to employing
evaluated through the existing process. approved by HL7 after publication of electronic systems for designated health
Once a HIPAA standard is adopted in the final rule, but DME is not one of the care related purposes) covering a time
a final rule, requests for changes to that named attachment types, covered span of 10 years. That analysis however
standard must be submitted through the entities will be able to use that AIS and did not include electronic health care
DSMO process, as set forth in the X12N 277/275 implementation claims attachments. Nonetheless, this
§162.910(c). After approval, the DSMOs guides with no regulatory requirements. section can be read in conjunction with
will forward proposed new In other words, use of a new AIS that the Transactions Rule analysis, since the
implementation specifications to the has not been formally adopted, as a statistics for electronic claims can be
NCVHS and to the Secretary. The standard by the Secretary, would be considered related to electronic claims
NCVHS serves as a consultative body voluntary, based on trading partner attachments.
that, under the provisions of the Public agreements or other such contracts, Executive Order 12866 directs
Health Service Act, provides advice unless and until regulations adopting agencies to assess all costs and benefits
concerning specified health care matters that AIS are proposed and made final of available regulatory alternatives and,
to the Secretary. Following consultation through the regulatory process. if regulation is necessary, to select
with appropriate agencies and regulatory approaches that maximize
organizations, including the NCVHS, IV. Collection of Information net benefits (including potential
the Secretary may adopt the modified Requirements economic, environmental, public health
versions as HIPAA standards through The burden associated with the and safety effects, distributive impacts,
the notice and comment rulemaking requirements in this regulation are the and equity). A regulatory impact
process. time and effort of health plans, health analysis (RIA) must be prepared for
Information pertaining to the care providers and/or health care major rules with economically
designation of DSMOs and their clearinghouses to modify their systems significant effects ($100 million or more
responsibilities can be found in the for the capability of sending health care in any 1 year). We consider this
Transactions Rule and the notice transactions electronically. This one- proposed rule to be a major rule, as it
announcing the DSMOs, which were time burden has already been approved will have an impact of over $100
published on August 17, 2000 (65 FR and accounted for in ‘‘HIPAA Standards million on the economy. This impact
50365, 50373). for Coding Electronic Transactions’’ analysis shows a potential net savings of
(OMB #0938–0866) with a current between $414 million and $1.1 billion
B. Additional Information over a 5-year period. We attempt to
expiration date of February 29, 2008.
Specifications for New Electronic provide information for the impact
However, we will amend this currently
Attachments analysis, focusing on savings
approved collection to include
We expect that the HL7 ASIG will electronic health claims attachments to projections, since cost data on the
continue to develop new standard AISs the list of covered transactions. HIPAA transactions are not yet available
using the HL7 CDA Release 1.0 from the industry. We solicit such data
framework, and these will be approved V. Response to Comments during the comment period for this
under the established DSMO process. Because of the large number of public proposed rule. Also, as referenced
After development and approval by the comments we normally receive on earlier, HHS provided funding for a
DSMO, new AISs will be sent to the Federal Register documents, we are not pilot to test the proposed standards, and
NCVHS and then to the Secretary for able to acknowledge or respond to them we anticipate that any cost/benefit
consideration. Upon receipt of new individually. We will consider all information that comes of that study
will be provided before the final rule is under this proposed rule. For example, agencies assess anticipated costs and
published. the SBA revisions increased the annual benefits before issuing any rule that may
The RFA requires agencies to analyze revenues for physician offices to $8.5 result in expenditures in any one year
options for regulatory relief of small million (other practitioners’ offices’ by State, local, or tribal governments, in
businesses. For purposes of the RFA, revenues remained at $6 million) and the aggregate, or by the private sector, of
small entities include small businesses, increased the small business size $110 million. This proposed rule has
nonprofit organizations, and small standard for hospitals to $29 million in been reviewed in accordance with the
government jurisdictions. Many annual revenues. Unfunded Mandates Reform Act of 1995
hospitals and most health care providers The regulatory flexibility analysis for and Executive Order 12875.
and suppliers are small entities, either this proposed rule is linked to the In the Transaction Rule’s impact
by nonprofit status or by having aggregate flexibility analysis for all of analysis, State Medicaid agencies
revenues of $6 to $29 million or less in the Administrative Simplification estimated that they could spend $10
any 1 year. For purposes of the RFA, standards that appeared in the million each to implement the entire set
nonprofit organizations are considered Transactions Rule (65 FR 50312), of HIPAA transactions. Since electronic
small entities; however, individuals and published on August 17, 2000, which claims attachments are only one
States are not included in the definition predated the SBA changes noted above. component of the entire transaction set,
of a small entity. For details, see the In addition, all HIPAA regulations and we believe that some of the
Small Business Administration’s current published to date have used the SBA programming completed for the current
regulation that set forth size standards size standards that existed at the time of transactions will be useable for
for health care industries at (65 FR the publication of the Transactions processing electronic health care claims
69432). Rule. For this analysis, we use the attachments, we do not believe that the
Effective October 1, 2000, the SBA no current SBA small business size States, in aggregate, will exceed the
longer used the Standard Industrial standards. Even though the SBA has $110 million UMRA expenditure
Classification (SIC) System to categorize raised the small business size standards, threshold for these new attachment
businesses and establish size standards, the revised size standards have no effect transactions.
and began using industries defined by on the cost and benefit analysis for this State Medicaid agencies, which are
the new North American Industry proposal. The revised standards simply statutory health plans under HIPAA,
Classifications System (NAICS). The increase the number of health care currently require and use a variety of
NAICS made several important changes providers that are classified as small attachments to adjudicate claims. In
to the Health Care industries listed in businesses. order to validate the fiscal and
the SIC System. It revised terminology, One source of information about the operational impact of this rule, current
established a separate category (Health health data information industry is data on the number and types of claims
Care and Social Assistance) under Faulkner & Gray’s Health Data Directory attachments for each State would be
which many health care providers are (CY 2000 edition). Using this resource, necessary, particularly whether the
located, and increased the number of health care clearinghouses, billing attachment types we name affect any
Health Care industries to 30 NAICS companies, and software vendors may significant percentage or number of
industries from 19 Health Services SIC also be considered small entities. Medicaid claims. We are aware of an
industries. However, for the same reasons cited industry wide survey that was
On November 17, 2000, the SBA elsewhere, we do not have any cost data conducted in the winter of 2005, which
published a final rule, which was to determine if this rule would have a may provide some insight into this
effective on December 18, 2000, in significant impact on small entities. information for States, if the Medicaid
which the SBA adopted new size In addition, section 1102(b) of the Act agencies and Medicaid providers
standards, ranging from $5 million to requires us to prepare a regulatory participated in the survey. In addition,
$25 million, for 19 Health Care impact analysis if a rule may have a during the comment period, we hope
industries. It retained the existing $5 significant impact on the operations of that State Medicaid agencies will
million size standard for the remaining a substantial number of small rural provide such information.
11 Health Care industries. The revisions hospitals. This analysis must conform to HHS estimated that the private sector
were made to more appropriately define the provisions of section 603 of the would require expenditures in excess of
the size of businesses in these industries RFA. For purposes of section 1102(b) of $110 million to implement all of the
that SBA believes should be eligible for the Act, we define a small rural hospital transaction standards. Since electronic
Federal small business assistance as a hospital that is located outside of health care claims attachments are only
programs. a Core-Based Metropolitan Statistical one of the eight transactions, and since
On August 13, 2002, the SBA Area and has fewer than 100 beds. there are only six attachment types at
published a final rule that became Because these attachment standards are this time, our assumption is that
effective on October 1, 2002. The final not mandatory for all health care expenditures to meet just the electronic
rule amended the existing SBA size providers, but rather only for those health care claims attachment
standards by incorporating OMB’s 2002 health care providers who conduct a requirements will not exceed the UMRA
modifications to the NAICS into its table transaction electronically for which the threshold for the private sector. Even if
of small business size standards. Secretary has adopted a standard, small our assumption is incorrect, and the
On September 6, 2002, the SBA rural hospitals can continue to operate costs of implementing the electronic
published a subsequent final rule as they do today, and we do not health care claims attachments
(effective October 1, 2002) that corrected anticipate a significant financial and standards exceed the UMRA threshold,
the August 13, 2002 final rule and business impact on these covered we believe that anticipated benefits of
contained a new table of size standards entities. For a more detailed discussion the proposed rule justify the added
to clearly identify these organizations by of small rural hospitals, please refer to costs.
dollar value and by number of the Transactions Rule, 65 FR 50312. The anticipated benefits and costs of
employees. Some of the revisions in size Section 202 of the Unfunded these proposed standards, and other
standards affected some of the entities Mandates Reform Act of 1995 (UMRA) issues raised in section 202 of the
that are considered covered entities (2 U.S.C. 1501 et seq.) also requires that UMRA, are addressed later in this
section. In addition, under section 205 principles, criteria, and requirements in transactions, we assessed the potential
of the UMRA (2 U.S.C. 1535), having Executive Order 13132; that this of the later versions of ASC X12N 277—
considered at least three alternatives for proposed rule is not inconsistent with Health Care Claim Request For
the transaction standard (X12 275 that Order; that this proposed rule Additional Information transaction; the
version 4010, IEEE, DICOM) and two would not impose significant additional ASC X12N 275—Additional Information
options for the code sets (claims status costs and burdens on the States; and to Support a Health Care Claim or
and LOINC), as outlined in the that this proposed rule would not affect Encounter transaction; the HL7 CDA
preamble to this rule and in the the ability of the States to discharge message standard; and the six HL7 AIS.
following analysis, HHS has concluded traditional State governmental These standards were measured against
that this proposed rule is the most cost- functions. the key principles listed in this
effective alternative for implementing proposed rule: achieve the maximum
1. Affected Entities (Covered Entities)
HHS’s statutory objective of benefit for the least cost; avoid
administrative simplification. All health plans, health care incompatibility; be consistent with the
Executive Order 13132 establishes clearinghouses, and covered health care other HIPAA standards; and be
certain requirements that an agency providers that transmit any health technologically independent of
must meet when it promulgates a information in electronic form in computer protocols used in HIPAA
proposed rule (and subsequent final connection with a claims attachment transactions. Specifically, the goal of
rule) that would, if finalized, impose which use other electronic format(s), improving the effectiveness and
substantial direct requirement costs on and all health care providers that decide efficiencies of the health care system
State and local governments, preempt to change from a paper format to an through electronic means is supported
State law, or otherwise have Federalism electronic process for claims by these standards. We found that these
implications. Executive Order 13132 of attachments, would have to begin to use transactions and specifications met all
August 4, 1999, Federalism, published the ASC X12N 277—Health Care Claim the principles, because once systems
in the Federal Register on August 10, Request For Additional Information and and operations are upgraded to send
1999 (64 FR 43255), requires the ASC X12N 275—Additional Information and receive the data in the new format
opportunity for meaningful and timely to Support a Health Care Claim or and with predictable content, many
input by State and local officials in the Encounter and the accompanying HL7 other business processes will be
development of rules that have specifications for requesting and improved.
Federalism implications. The submitting electronic health care claims
Department consulted with appropriate attachments. Currently, there are no B. Cost and Benefit Analysis
State and Federal agencies, including standardized electronic claim [If you choose to comment on issues
tribal authorities and Native American attachment formats in consistent use in this section, please include the
groups, as well as private organizations. across the industry. Since health care caption ‘‘COSTS AND BENEFITS’’ at
These private organizations included providers have the option of continuing the beginning of your comments.]
WEDI and the DSMO coordinating to submit paper attachment information,
there would be little potential for 1. General Assumptions, Limitations,
committee.
The Department has examined the disruption of claims processes and and Scope
effects of provisions in the proposed timely payments during a particular Attachments to health care claims
rule as well as the opportunities for health plan’s transition to the ASC will be requested electronically by using
input by the States to the proposed rule. X12N 277, ASC X12N 275, HL7 the ASC X12N 277—Health Care Claim
The Federalism implications of the standards and LOINC code set use. Request For Additional Information
proposed rule are consistent with the Implementation will simplify transaction which includes LOINC
provisions of the Administrative processing for attachments and reduce codes to identify the supplemental
Simplification subtitle of HIPAA by administrative expenses for covered claim information being requested.
which the Department was required by health care providers. Health plans will Similarly, the attachment response will
the Congress to promulgate standards be able to automate the processing of be conveyed electronically by the ASC
for the interchange of certain health care attachment information, thus reducing X12N 275—Additional Information to
information via electronic means, which their labor costs and improving the Support a Health Care Claim or
standards, by statute, preempt contrary accuracy of attachment responses from Encounter transaction, serving as an
State law. covered health care providers. The costs envelope for the HL7 message and
The States were invited to participate of implementing the X12 and HL7 Additional Information Specification.
in the electronic claims attachment standards with the LOINC code set are While an attachment can be sent at the
standard development process from its generally one-time costs related to same time as the original claim is
beginning in 1994. During the early conversion. The systems upgrade costs submitted, based on instructions from
stages, a concept paper that set forth the for small covered health care providers, the health plan, it will usually be sent
transactions, code sets, and key issues health plans, and health care in response to a specific request after a
being considered for the proposed rule clearinghouses will vary depending claim has been submitted. Accordingly,
was provided to the States for review upon the capabilities of hardware and this analysis considers the request, the
and comment. Those comments have software systems in use at the time these response, the HL7 message standard,
been considered in preparation of this changes are being made. Administrative and the six additional information
proposed rule. The National Medicaid costs may increase depending on the specifications as an ‘‘attachment
EDI HIPAA work group (NMEH) has a data entry and data conversion options package’’ that cannot be subdivided for
claims attachment subcommittee, which selected in order to comply with the purposes of any financial analysis since
will be active in ensuring that each State standard. they cannot logically be implemented as
is given the opportunity to provide separate stand-alone transactions.
input during the public comment 2. Effects of Various Options
period. The Department concludes that After ruling out certain versions of Limitations
the policy in this proposed rule has transactions based on limitations Most health plans, health care
been assessed in accordance with the identified by early adopters of X12 clearinghouses, and covered health care
providers were required to comply with did not include electronic attachments electronically today; and vendors,
the Transaction Rule standards in 2002, to health care claims because no health plans and health care providers
or 2003, depending on the entity type standard was forthcoming at that time. say that they will not move forward on
and the applicability of the However, electronic attachments are this until the HIPAA standards are
Administrative Simplification viewed as a minor incremental cost adopted. The early evidence from the
Compliance Act (ASCA), which compared to the total cost assessed in current pilot bears this out, as the
permitted certain covered entities to the August 2000 Transactions Rule, hospital providers have said that they
apply for an extension of the because covered entities have readied will not undertake full scale
compliance date. Widespread their systems for the other X12 implementation until the regulation is
implementation of the HIPAA transactions and will have ample published.
Transaction Rule was further delayed experience with X12 by the time the The following assumptions are based
when covered entities invoked final rule for electronic health care upon anecdotal comments by industry
contingency plans under an claims attachments is effective. The professionals, as well as the
enforcement discretion strategy analysis here can be an adjunct to that Department’s general knowledge of
guidance document that had been which was provided in the Transactions present circumstances in the health care
issued by CMS. One of the results of Rule, since the volume of attachments is industry. Beyond our anecdotal
these implementation delays is that directly related to the volume of health information, and subsequent
industry-wide cost data could not be care claims. assumptions, the only available data we
compiled for HHS to use in assessing As we note earlier, data and have for hospitals and physicians,
the actual financial impact (that is, cost information about claims attachments indicates that their services represent
or savings projections) of implementing was gleaned primarily from the 1993 over 50 percent of the claims submitted
any of the original transactions. WEDI report entitled: ‘‘The 1993 WEDI annually. Furthermore, their services
The lack of data available today Report and Recommendations.’’ Some are likely to be those most affected by
regarding any industry wide HIPAA other general data on claim volumes the six electronic attachments proposed
transaction costs or savings; on the was gathered from a CY2000 publication in this rule. One subject matter expert
current use of claims attachments; the from Health Data Management and from a national health plan indicated
costs of manual processes; or the impact anecdotally, from informal discussions that 50 percent of all claims attachments
of conducting any transactions with industry representatives of health are likely to be represented by the six
electronically, imposes a significant plans and vendors. There were no attachment types named here. We
limitation to any quantitative analysis. surveys or proprietary data available request comments and any data that will
Therefore, in order to prepare this from the BlueCross BlueShield supplement these and all other
proposed rule, HHS used older available Association (BCBSA), the American assumptions in this section:
studies and anecdotal observations from Medical Association (AMA), the • Few health care claims attachments
the industry and SDOs. Since the American Hospital Association (AHA), are requested or submitted using an
analysis in the Transaction Rule America’s Health Insurance Plans electronic format of any kind.
specifically excluded costs and benefits (AHIP), The Association for Electronic • Preparation and processing of
for electronic health care claims Health Care Transactions (AFEHCT), electronic claims attachments (requests
attachments, it further highlighted the X12, HL7 or any other professional and responses) will entail workload
data limitations we were faced with for organization or SDO. effort that is similar in complexity and
this analysis. The 1993 study by WEDI suggested duration as that associated with the
HHS used the 1993 WEDI report that 25 percent of all health care claims preparation and processing of an
coupled with conservative assumptions required support by an attachment or electronic claim, for both health care
from the Transaction Rule to predict additional documentation. Though providers and health plans.
costs and savings at a high level. We these data on attachments are over 10 • The volume of unsolicited
solicit information from the industry years old, they are currently the only set attachments accompanying original
regarding implementation costs for the of broad-based information available health care claims today is relatively
current HIPAA transactions, in addition from the industry. We acknowledge that small.
to: the frequency of claims attachments; this 1993 statistic does not take into • Health care providers will not all be
the types of attachments currently being account changes that have occurred equally impacted by the electronic
requested (by service and/or procedure); following implementation of the HIPAA claims attachment standards. Some
the workload associated with requesting Transaction and Privacy Rules, nor health care provider types (for example,
attachment information and providing more recent health plan business rule ambulance companies, providers of
the response; the costs that may be changes for how claims are adjudicated rehabilitation services, and hospitals or
incurred implementing new software, and what attachments are now being other facilities that operate emergency
practice management systems, and other requested. Nonetheless, these are the departments) are more likely to elect to
tools; as well as any other relevant cost most comprehensive data available. If conduct attachment transactions
data that could supplement this current attachment statistics exist, we electronically because of the frequency
analysis. We also hope to receive hope the industry and/or its of the requests. Other health care
information from WEDI, following their representatives will provide those data providers may decide to implement the
efforts to engage the industry in during the comment period. transactions later, opting to continue
discussing Return on Investment (ROI) We also assume in this impact providing requested information via
from HIPAA—an initiative expected to analysis that electronic health care paper-to-paper fax or paper copies in
begin in the fall of 2005. claims attachments would not be the short term.
The impact analysis in the August implemented at all, and certainly not The cost and benefit analysis is
2000 Transactions Rule assessed the with uniform standards, in the absence separated into various sub-sections
expected costs and benefits associated of this rule. This assumption is based on below. In addition, there is a section
with the Administrative Simplification direct industry comment, and current that discusses the financial impact of
regulations covering a time span of 10 industry practice to date—very few implementation covering a 5-year time
years, beginning in 2002. That analysis attachments are being sent span, from 2007 to 2011. We use a five
year time span to match the remainder • Learning about and training staff on electronic record systems to support the
of the 10-year period that was used in the new electronic claims attachment rapid retrieval of information, and
the Transaction Rule; that analysis standards, the X12 implementation respond to requests.
calculated costs and benefits through guides, HL7 AIS and LOINC codes. • More accurate tracking and receipt
2011. • Programming systems to of attachment information, resulting in
accommodate the new transaction types, fewer lost documents.
2. Cost and Benefit Analysis for Health messaging standards, and codes.
Plans • Receipt of payment more quickly.
• Mapping the LOINC codes to We solicit industry input as to the
a. Health plans may incur the current proprietary codes. anticipated implementation costs for
following implementation costs: • Installing LOINC codes. technical, business and operational
• Learning about and training staff on • Software and/or vendor fees.
• Practice management system changes that may be required, as well as
the new claims attachment standards, on anticipated savings.
the X12 implementation guides, HL7 vendor fees and charges.
• Health care clearinghouse fees. We do not make any assumptions
AIS booklets, and LOINC codes. about the fiscal impact to
• Programming systems to • Changing business practices and re-
training staff to enter different data, clearinghouses, because there was no
accommodate the new transaction types,
perform different functions, conduct baseline data in the 1993 WEDI report,
messaging standards, and codes.
• Installing LOINC codes. different procedures. and no current data on their costs for
• Mapping the LOINC codes to the • Purchasing or expanding server implementing the HIPAA transactions
current attachment request reason space. over the past several years. Nonetheless,
codes. • Acquiring XML expertise. we believe that costs would be similar
• Acquiring translator capability to • Purchasing or enhancing translator to those incurred by both health plans
process HL7 messages. software. and health care providers, because of
• Telecommunication expansion. • Telecommunication expansion. the programming, mapping, translating
• Server expansion to retain • Utility conversion programs. and storage functions for which they
electronic records. Again, many of these items should not may be responsible. We anticipate that
• Other potential software upgrades represent unusual expenditures for AFEHCT, HIMSS and AHIMA, to name
for browsing, translating, and validating, covered health care providers and/or a few associations, will compile data on
as well as internal controlling or their business associates, as some of the costs and potential savings for their
messaging/routing functions. same kinds of tasks will have been constituents in order to avoid concerns
• Health care clearinghouse fees. accomplished through HIPAA over proprietary and competitive data.
• Acquiring XML expertise. transactions compliance activities to Such deidentified data may be useful for
• Changing business practices and date. Small practices that have practice comments on this proposal. A vendor
retraining staff to accommodate management or software maintenance forum held in August 2005 may
electronic attachments versus paper agreements are likely to be provided encourage analysis within the industry
attachments and records. with appropriate software upgrades at itself.
These items should not represent modest costs, in view of the market
unusual expenditures, as some of the competition for that business sector. 4. Cost and Benefit Estimates
same kinds of tasks will have been Covered health care providers with their a. Costs of Implementation: The
accomplished through HIPAA own EDI software may incur some transaction standards proposed in this
Transaction compliance activities. We added costs to obtain HL7 capabilities rule are in the same family of X12
also understand that several firms that for their translators. The costs for standards as the other HIPAA-mandated
provide translators already have HL7 covered health care providers to transactions. Therefore, any new
capabilities in their HIPAA-capable implement this proposal for electronic activities necessary to implement the
translators. attachments to health care claims are electronic health care claims attachment
b. Health plan savings could accrue not considered to be significant and transactions should be consistent with
from: many implementation costs for what has already been done, and may be
• Using standardized attachment transactions were estimated to be one- largely in place. The HL7 message
requests. time expenditures rather than recurring standard is used in many clinical
• Receiving consistent response ones. settings already, and laboratories and
information. b. Savings could accrue from the some other health care organizations use
• Eliminating paper documents and following: the LOINC codes.
the manual efforts to request, receive, • Use of standardized, predictable
process, and handle the documents. attachments, and formats rather than While the Department had estimated
• Reducing postage costs. numerous proprietary forms associated costs in the impact analysis for the other
• The ability to electronically with individual health plan transactions adopted under the
adjudicate health care claims supported requirements. Transaction Rule, we believe that
by an electronically submitted • Reduction of paper documents and covered entities now have data
attachment. manual efforts to receive, process, and regarding the actual costs for this
We solicit industry input as to the respond to requests. implementation, and are themselves in
anticipated implementation costs for • Reduction in postage and mailing the best position to provide current data
technical, business and operational costs. regarding the implementation costs of
changes that may be required, as well as • Reduction in labor costs. this proposal.
anticipated savings. • Minimization of ambiguities, which The 1993 WEDI report did not
frequently result in multiple provide data specific to claims
3. Cost and Benefit Analysis for Covered communication exchanges before the attachments, and no reports since that
Health Care Providers desired information is correctly time have attempted to quantify
a. Covered health care providers may identified and provided. volumes or costs. The report was
incur the following implementation • Application of automation by extremely limited in data for health
costs: covered health care providers with plans on this subject.
In light of existing limitations, we electronic health care claims data to allow for a reasonable analysis
repeat our solicitation for attachments would likely cost 10 of costs and savings, updated estimates
implementation cost information from percent of what covered entities may be provided in the final rule on
affected entities. We are providing high- expended on their overall HIPAA these standards.
level cost and savings estimates in this implementation efforts. We use this
The tables below illustrate the
proposed rule based on the 1993 data figure for our cost estimates below. It is
estimated costs for health plans and
and the final Transactions Rule. the only current figure available,
Anecdotally, we have heard from following extensive research and health care providers to implement
industry representatives that discussion over the past 18 months. If electronic health care claims
implementing the standards for the industry submits sufficiently robust attachments.
TABLE 3.—FIVE YEAR COSTS FROM TRANSACTIONS RULE

[In billions]
Costs 2007 2008 2009 2010 2011
Providers .................................................................. $1.2 ........................... $1.2 ........................... $1.1 ........................... ............ ............
Health plans ............................................................. 1.2 ............................. 1.2 ............................. 1.1 ............................. ............ ............
10% of costs ............................................................ 120 million ................. 120 million ................. 110 million ................. ............ ............
We used Table 4 from the submitted in the year 2000. claims. Table 4 below, Total Health Care
Transactions Rule to demonstrate an Furthermore, of the 5.1 billion health Claims (in millions), presents a low-
estimate of implementation costs for claims submitted, Gartner believes that high sensitivity range for the number of
electronic health care claims 486 million claims were from hospitals physician and hospital claims for years
attachments for both health plans and and 1.9 billion claims were from 2007 through 2011. Our model uses
providers. Using the recent informal physicians. This translates to 2007 as the first year; since this is the
industry estimate that implementation approximately 10 percent and 38 anticipated year covered entities will
of the electronic health care claims percent of all health claims being need to be compliant with the
attachments standards would cost 10 submitted by hospitals and physicians regulation.
percent of what covered entities spent respectively. As stated earlier, this proposed rule
on overall HIPAA implementation To predict a trend for total annual uses a 5-year period for its analysis, in
yields an estimate of $120 million in physician and hospital claims beyond order to synchronize its potential
each of the first 2 years for both sectors. the year 2000 figures provided by the implementation schedule with the date
The first 3 years are deemed to have the consulting firm, we used the CMS line established in the original
implementation costs, while future growth rates of Medicare Parts A & B Transactions Rule. Since the initial
expenses are related to operations, and claims from 2001 through 2005 (listed compliance date for the Transactions
not reflected in implementation in the CMS Justification of Estimates for Rule was 2002, the end date for that
estimates. Appropriations Committees Fiscal Year analysis was 2011. In this proposed
2005 Report (DHHS)) and applied those rule, we begin our estimates in 2007,
b. Benefits of Implementation
as the associated growth rates for our and end in 2011.
In order to estimate the benefits of physician and hospital health claims The Table below (Table 4) reflects the
electronic claims attachments, we model for 2001 through 2005. estimated number of claims for years
applied the methodology described Furthermore, for the years 2006 through 2007 through 2011. As part of a
below. According to Gartner, Inc., a 2011, we assumed the continued 2005 sensitivity analysis, the high numbers
management research and consulting Parts A and B average growth rate of 4 reflect a 30 percent increase in the
firm, 5.1 billion health care claims were percent for physician and hospital claims count for the same years.
TABLE 4.—TOTAL HEALTH CARE CLAIMS—PHYSICIANS AND HOSPITALS

2007 2008 2009 2010 2011
Low High Low High Low High Low High Low High
Physician Claims .................................................................. 2,832 3,682 2,946 3,829 3,064 3,983 3,186 4,142 3,314 4,308
Hospital Claims .................................................................... 708 921 736 957 766 996 797 1,035 828 1,077
The 1993 WEDI Report concluded claims for each year from 2007 through procedure electronic claims attachment
that 25 percent of all health care claims 2011; or 12.5 percent of all claims. We types proposed here, nor what volumes
require some sort of additional know this results in a large number of these represent of the total number of
documentation, or attachment. Current potential claims attachments; and this attachment types required by a
anecdotal estimates are that 50 percent number is undoubtedly higher than the significant number of health plans.
of all attachments are represented by number of claims that might actually Again, we solicit data from health care
those included in this proposed rule. As require one of the six electronic providers and health plans on this topic.
these are the only data available, we attachment types proposed here.
assumed 50 percent of the rate of 25 Nonetheless, we do not have any hard
percent for attachments on our industry data on what percent of claims
estimated physician and hospital health are submitted for the six service and
TABLE 5.—TOTAL HEALTH CARE CLAIMS ATTACHMENTS—PHYSICIANS AND HOSPITALS

[In millions]
2007 2008 2009 2010 2011
Attachments volume: 50 percent of the estimated 25 per-

cent of all Physician Claims ............................................. 354 460 368 458 383 498 398 518 414 538
Attachments volume: 50 percent of the estimated 25 per-
cent of all Hospital Claims ................................................ 89 115 92 119 96 124 100 129 104 135
Table 5 shows the number of telephone, and forms. Other savings For physicians, we assumed the WEDI
electronic health care claims may accrue to covered health care operational savings of $1.01 within our
attachments that could potentially be providers because they will experience low category and $1.96 within our high
required for health care claims (in a reduction in the days between claims category for each of the 5-year
millions), in spite of the increase in submission and claims payment. Since calculations. For hospitals, we assumed
electronic data exchange through the there was no other quantitative the WEDI operational savings of $0.64
other HIPAA transactions. The data are information from the industry outlining within our low category and $1.07
shown from a low range to a high range the costs and benefits of the transition within our high category for each of the
to demonstrate that the volumes are to EDI, we constructed our estimates by 5-year calculations. We do not provide
large in either case. using the WEDI operational savings any savings assumptions for health
According to the 1993 WEDI Report, figures above in our assumptions and plans, as no relevant data were available
operational savings per transaction calculations. We note here that the through any reports shared with us. We
through the use of electronically hope that the health plan industry will
WEDI report did not estimate a per
submitted claims varies between $1.01 submit such data to HHS during the
transaction cost for electronic
to $1.96 for physicians and $0.64 to comment period. We also note here that
$1.07 for hospitals, net of transaction attachments or medical records operational savings calculations include
costs (assumed to be up to $0.50 per exchange between a health care costs and savings (costs less savings
claim). WEDI believed that conversion provider and a health plan. WEDI equal operational savings with this
from a paper-based process to an provided an estimate of a net savings methodology). In this proposed rule, we
electronic transaction process would potential of $1.5 billion in labor from attempt to reflect cost and savings
include savings on labor costs as a result copying and shipment of medical estimates based on available research as
of standardized information and records between health care providers, well as current informal and anecdotal
procedures, and a decrease in non- though not for the purpose of claims input from industry subject matter
personnel expenses such as postage, attachments. experts.
TABLE 6.—OPERATIONAL SAVINGS FROM ELECTRONIC HEALTH CARE CLAIMS ATTACHMENTS—PHYSICIANS AND
HOSPITALS
[In millions]
2007 2008 2009 2010 2011
Physicians ............................................................................ 358 902 372 938 387 976 402 1,015 418 1,055
Hospitals ............................................................................... 57 123 59 98 61 133 64 138 66 144
Operational Savings ...................................................... 415 1,025 431 1,036 448 1,109 466 1,153 485 1,199
Table 6, Operational Savings from being submitted are in HIPAA from paper to electronic processing by
Electronic Health Care Claims compliant formats. We believe that most the end of the year 2007. We used lower
Attachments (in $ millions), shows the covered entities will choose to conversion rates for the first few years
total operational savings that could be implement the human variant option of implementation because not all paper
achieved. The calculations for number first, which does not have significant attachments can automatically be
of claims attachments are made using technical complexities. Therefore, we moved to an electronic process; and
the figures in Table 5 and the WEDI use the following conversion factors, or only six attachment types have
savings assumptions for physicians and ‘‘adoption rates’’ from paper to approved HL7 specifications at present.
hospitals. electronic attachments: 5 percent for The conversion factors were based on
Next, we assumed a fairly optimistic 2007, 20 percent for 2008, 50 percent for
the 1993 WEDI report, which as has
rate of adoption for the electronic health 2009, 75 percent for 2010, and 90
been stated, remains the only available
care claims attachment transactions, percent for 2011. For example, using the
because, based on Medicare’s low end of attachment volumes found in data source. However, as mentioned
experience, two years past the Table 5, 5 percent of the 354 million earlier, HIPAA compliance and
compliance date for the original set of attachments (total low) for physician adoption rates are promising, just 2
transactions, 99 percent of the claims claims are expected to be converted years after the compliance date.
TABLE 7.—OPERATIONAL SAVINGS FROM ELECTRONIC HEALTH CARE CLAIMS ATTACHMENTS BASED ON SPECIFIC RATES
OF CONVERSION
[In millions]
2007 2008 2009 2010 2011

(@ 5 percent (@ 20 percent (@ 50 percent (@ 75 percent (@ 90 per-
conversion) conversion) conversion) conversion) cent conver-
sion)
Total Operational Savings for each conversion factor ........ 21 51 86 213 224 554 349 865 436 1,079
Table 7 represents operational savings requires all cost-benefit analyses to that could be attained for physicians
from electronic health care claims provide estimates of net benefits using and hospitals when using the standard
attachments using the estimated both 3 percent and 7 percent discount for electronic attachments. These figures
conversion factors. We took the rates (Office of Management and Budget, take into account both undiscounted
operational savings figures shown in Circular A–4, September 17, 2003). and discounted (3 percent and 7
Table 6 and applied the conversion rates Table 8, 5-Year (2007 through 2011) percent) amounts, respectively, as well
for each of the 5 years. Total Operational Savings (in $ as annualized savings.
In its A–4 circular, the Office of millions), shows the potential savings
Management and Budget (OMB)
TABLE 8.—FIVE-YEAR (2007 THROUGH 2011) OPERATIONAL SAVINGS ($ MILLIONS)—DISCOUNTED (3 PERCENT AND 7
PERCENT) AND ANNUALIZED PROJECTIONS
[In millions]
Total savings Total savings Annualized savings Annualized savings

(discounted at 3 per- (discounted at 7 per- (discounted at 3 per- (discounted at 7 per-
cent) cent) cent) cent)
Low High Low High Low High Low High
Total Operational Savings Achieved Using

Conversion Factor for Paper to Electronic
Attachments .................................................. 1,023 2,532 915 2,264 205 506 183 453
As final explanation of our use of the available today related to electronic operational savings, for both physicians
older formal data, and current informal health care claims attachments. and hospitals, ranges between $431
estimates, in preparing this proposed OMB requires that all agencies million and $1 billion. Using the
rule we conducted extensive research to provide estimates using net present assumed second year conversion rate of
obtain up-to-date information. Data values. OMB recommends the use of 3 20 percent could yield an estimated
regarding paper versus electronic claims percent and 7 percent discount rates total operational savings range of $86
were not available beyond the year based on current cost of capital. The million to $213 million. For 2009, the
2000, perhaps in preparation for HIPAA discounted totals in Table 8 are based estimated operational savings, for both
and the assumption that data would be on these rates, and begin in 2007. physicians and hospitals, ranges
available post implementation. We used between $448 million and $1.1 billion.
5. Conclusions
a variety of other resources, including Using the assumed third year
As shown in Table 3, Costs conversion rate of 50 percent yields an
Medicare claims data, external research
Associated with Electronic Health Care estimated total operational savings
organizations such as Gartner, and
Claims Attachments, the estimated costs range of $224 million to $554 million.
contractors to estimate the number of are $120 million dollars for the first 2 In 2010, the estimated operational
electronic health care claims years, and slightly less in the third year. savings, for both physicians and
attachments, conversion rates, With regard to operational savings, the hospitals, ranges between $466 million
operational savings for each conversion range is from $414 million to $1.1 and $1.1 billion. Using the assumed
factor, and total operation savings. The billion over five years. In calendar year fourth year conversion rate of 75 percent
newly established Office of the National 2007, maximum operational savings, for yields an estimated operational savings
Coordinator for Health Information both physicians and hospitals, is range of $349 million to $865 million.
Technology (ONCHIT) also did not have estimated to range between $414 million In 2011, the estimated total maximum
current data that have provided any to $1 billion. operational savings, for both physicians
further insight for the impact analysis. When we use the term ‘‘conversion and hospitals, ranges between $485
Studies pertaining to the adoption of rate,’’ we use it to mean the transition million and $1 billion. Using the
electronic medical record systems (EMR from a paper-based system to an EDI assumed fifth year conversion rate of 90
or EHR) and the integration of those based process. As table 7 shows, using percent yields an estimated total
with financial and administrative the assumed first year conversion rate of operational savings range of $436
systems may be able to provide some 5 percent yields an estimated total million to $1 billion.
useful information for the final rule in operational savings range of $21 million The 5-year (2007 through 2011) total
a few years time, but there is none to $51 million. For 2008, the estimated operational savings presented in Table 8
shows a total operational savings range, Organization or other private or public ASC X12 and HL7 standards and code
for physicians and hospitals, of $1 organization that would ensure sets in terms of simplicity, ease of use
billion to $2.5 billion, using the 3 continuity and efficient updating of the and cost. Covered entities have a variety
percent discounted rate. While using the standard over time. This principle of ways in which they can choose to
7 percent discounted rate translates to a supports the regulatory goal of send and/or receive an ASC X12
total operational savings range of $915 predictability. transaction or HL7 message, including
million to $2.2 billion. In addition, this • Have timely development, testing, internal reprogramming of their own
table shows an annualized operational implementation, and updating systems, contracting with vendors and
savings range, for physicians and procedures to achieve administrative purchasing off-the-shelf translator, or
hospitals, between $205 million and simplification benefits faster. This interface engine programs.
$506 million using the 3 percent principle establishes a performance The selection of the LOINC code set
discounted rate, and between $183 objective for the standard. for conveying meaningful information
million and $453 million using the 7 • Be technologically independent of between trading partners represents
percent discounted rate. the computer platforms and another opportunity to control user
In accordance with the provisions of transmission protocols used in HIPAA costs, since this code set is available for
Executive Order 12866, this proposed health transactions, except when they use without payment of licensing fees.
rule has been reviewed by the Office of are explicitly part of the standard. This
principle establishes a performance List of Subjects in 45 CFR Part 162
Management and Budget.
objective for the standard and supports Administrative practice and
C. Guiding Principles for Standard the regulatory goal of flexibility. procedure, Electronic transactions,
Selection • Be precise and unambiguous but as Health facilities, Health insurance,
1. Overview simple as possible. This principle Hospitals, Incorporation by reference,
supports the regulatory goals of Medicare, Medicaid, Reporting and
The implementation teams charged predictability and simplicity. recordkeeping requirements.
with designating standards under the • Keep data collection and paperwork
statute have defined, with significant For the reasons set forth in the
burdens on users as low as is feasible. preamble, the Department of Health and
input from the health care industry, a This principle supports the regulatory
set of common criteria for evaluating Human Services proposes to amend 45
goals of cost-effectiveness and CFR subtitle A, subchapter C, part 162
potential standards. These criteria were avoidance of duplication and burden.
based on direct specifications in the to read as follows:
• Incorporate flexibility to adapt more
HIPAA, the purpose of the law, those easily to changes in the health care PART 162—ADMINISTRATIVE
principles that support the regulatory infrastructure (such as new services, REQUIREMENTS
philosophy set forth in Executive Order organizations, and provider types) and
12866 of September 30, 1993, and the information technology. This principle 1. The authority citation for part 162
PRA of 1995. In order to be designated supports the regulatory goals of is revised to read as follows:
as a standard, a proposed standard flexibility and encouragement of Authority: 42 U.S.C. 1320d–1320d–8, as
should do the following: innovation. amended, and sec. 264 of Pub. L. 104–191,
• Improve the efficiency and We believe that the standards being 110 Stat. 2033–2034 (42 U.S.C. 1320d–2
effectiveness of the health care system proposed in this regulation meet the (note)).
by leading to cost reductions for, or requirements of these guidelines. 2. In §162.103, the introductory text
improvements in, benefits from to the section is republished, and a
electronic HIPAA health care 2. General
definition for ‘‘LOINC’’ is added in
transactions. This principle supports the Converting to any standard would alphabetical order to read as follows:
regulatory goals of cost-effectiveness result in one-time conversion costs for
and avoidance of burden. covered health care providers, health § 162.103 Definitions.
• Meet the needs of the health data care clearinghouses, and health plans. For purposes of this part, the
standards user community, particularly Some covered health care providers and following definitions apply:
covered health care providers, health health plans would incur those costs * * * * *
plans, and health care clearinghouses. directly and others may incur them in LOINC stands for Logical
This principle supports the regulatory the form of a fee from health care Observation Identifiers Names and
goal of cost-effectiveness. clearinghouses or, for covered health Codes.
• Be consistent and uniform with the care providers, other agents such as
other HIPAA standards (that is, their * * * * *
practice management and software 3. In §162.920, the following changes
data element definitions and codes and system vendors. We do not include are made:
their privacy and security requirements) estimated costs to health care A. The section heading is revised.
and, secondarily, with other private and clearinghouses in our analysis, since B. The introductory text is revised.
public sector health data standards. This these costs are incurred on behalf of C. New paragraph (a)(10) is added.
principle supports the regulatory goals covered health care providers and D. New paragraph (a)(11) is added.
of consistency and avoidance of health plans, and are ultimately borne E. New paragraph (c) is added.
incompatibility, and it establishes a by them. Including health care The changes read as follows:
performance objective for the standard. clearinghouse costs in this analysis
• Have low additional development would therefore count those costs twice. § 162.920 Availability of implementation
and implementation costs relative to the We also do not include estimated specifications and guides.
benefits of using the standard. This costs for health plans in this analysis, A person or an organization may
principle supports the regulatory goals because no relevant data were available. directly request copies of the
of cost-effectiveness and avoidance of The lack of data overall is discussed in implementation standards described in
burden. the section called ‘‘limitations.’’ subparts I through S of this part, from
• Be supported by an ANSI- The standards named in this proposed the publishers listed in this section. The
Accredited Standards Developing rule compare favorably with typical Director of the Office of the Federal
Register approves the implementation Information Specification 0001, Regenstrief Institute, c/o LOINC, 1050
specifications and guides described in Ambulance Service Attachment, Release West Wishard Blvd., Indianapolis, IN
this section for incorporation by 2.1, based on HL7 CDA Release 1.0, May 46202.
reference in subparts I through S of this 2004, as referenced in §162.1915(b)(1) 5. A new subpart S is added to part
part in accordance with 5 U.S.C. 552(a) and §162.1925(c)(1). 162 to read as follows:
and 1 CFR part 51. The implementation (ii) Emergency department
Subpart S—Electronic Health Care Claims
specifications and guides described in information: The CDAR1AIS0002R021 Attachments
this paragraph are also available for Additional Information Specification
Sec.
inspection by the public at the Centers 0002: Emergency Department
162.1900 Definitions.
for Medicare & Medicaid Services, 7500 Attachment, Release 2.1, based on HL7 162.1905 Requirements for covered entities.
Security Boulevard, Baltimore, CDA Release 1.0, May 2004, as 162.1910 Electronic health care claims
Maryland 21244 or at the National referenced in §162.1915(b)(2) and attachment request transaction.
Archives and Records Administration §162.1925(c)(2). 162.1915 Standards and implementation
(NARA). For information on the (iii) Rehabilitation services specifications for the electronic health
availability of this material at NARA, information: The CDAR1AIS0003R021. care claims attachment request
call 202–741–6030, or go to: http:// Additional Information Specification transaction.
www.archives.gov/federal_register/ 0003: Rehabilitation Services 162.1920 Electronic health care claims
code_of_federal_regulations/ Attachment, Release 2.1, based on HL7 attachment response transaction.
162.1925 Standards and implementation
ibr_locations.html. Copy requests must CDA Release 1.0, May 2004, as
specifications for the electronic health
be accompanied by the name of the referenced in §162.1915(b)(3) and care claims attachment response
standard, number, if applicable, and §162.1925(c)(3). transaction.
version number. Implementation (iv) Clinical reports information: The 162.1930 Initial compliance dates for the
specifications and guides are available CDAR1AIS0004R021 Additional electronic health care claims attachment
for the following transactions: Information Specification 0004: Clinical response and electronic health care
(a) ASC X12N specifications. * * * Reports Attachment, Release 2.1, based claims attachment request transaction
(10) The ASC X12N 277—Health Care on HL7 CDA Release 1.0, May 2004, as standards.
Claim Request for Additional referenced in §162.1915(b)(4) and
Information, Version 4050 §162.1925(c)(4). Subpart S—Electronic Health Care
(004050X150), May 2004, Washington (v) Laboratory results information: Claims Attachments
Publishing Company as referenced in The CDAR1AIS0005R021 Additional § 162.1900 Definitions.
§162.1915. Information Specification 0005:
(11) The ASC X12N 275—Additional Ambulance services means health
Laboratory Results Attachment, Release
Information to Support a Health Care care services provided by land, water, or
2.1, based on HL7 CDA Release 1.0, May
Claim or Encounter, Version 4050 air transport and the procedures and
2004, as referenced in §162.1915(b)(5)
(004050X151), May 2004, Washington supplies used during the trip by the
and §162.1925(c)(5).
Publishing Company as referenced in (vi) Medications information: The transport personnel to assess, treat or
§162.1925. CDAR1AIS0006R021 Additional monitor the individual until arrival at
* * * * * Information Specification 0006: the hospital, emergency department,
(c) HL7 specifications. (1) The HL7 Medications Attachment, Release 2.1, home or other destination. Ambulance
CDAR1AIS0000R021 Additional based on HL7 CDA Release 1.0, May documentation may also include non-
Information Specification 2004, as referenced in §162.1915(b)(6) clinical information such as the
Implementation Guide, Release 2.1 and §162.1925(c)(6). destination justification and ordering
(based on HL7 CDA Release 1.0), May (3) The LOINC Modifier Codes practitioner.
2004, Health Level Seven, Inc. The AIS booklet ‘‘for use with ASC X12N 277 Attachment information means the
Implementation Guide for the HL7 Implementation Guides when supplemental health information
standard may be obtained from Health requesting Additional Information,’’ is needed to support a specific health care
Level Seven, Inc., 3300 Washtenaw available from Washington Publishing claim.
Avenue, Suite 227, Ann Arbor, MI Company, PMB 161, 5284 Randolph Clinical reports means reports,
48104–4250, or via the Internet at http:// Road, Rockville, MD 20852, or via the studies, or notes, including tests,
www.hl7.org; or from the Washington Internet at http://www.wpc-edi.com/. procedures, and other clinical results,
Publishing Company, PMB 161, 5284 4. In §162.1002, paragraph (c) is used to analyze and/or document an
Randolph Road, Rockville, MD 20852, added to read as follows: individual’s medical condition.
or via the Internet at http://www.wpc- Emergency department means a
edi.com/. § 162.1002 Medical data code sets. health care facility or department of a
(2) The HL7 Additional Information * * * * * hospital that provides acute medical
Specifications for each of the six (c) For the period beginning [24 and surgical care and services on an
attachments listed in §162.1915 and months after the effective date of the ambulatory basis to individuals who
§162.1925 may be obtained from Health final rule published in the Federal require immediate care primarily in
Level Seven, Inc., 3300 Washtenaw Register]: Logical Observation critical or life-threatening situations.
Avenue, Suite 227, Ann Arbor, MI Identifiers Names and Codes Laboratory results means the clinical
48104–4250, or via the Internet at http:// (LOINC), as maintained and information resulting from tests
www.hl7.org; or from Washington distributed by the Regenstrief Institute conducted by entities furnishing
Publishing Company, PMB 161, 5284 and the LOINC Committee. The biological, microbiological, serological,
Randolph Road, Rockville, MD 20852, LOINC database may be obtained from chemical, immunohematological,
or via the Internet at the Regenstrief Institute Web site at the hematological, biophysical, cytological,
http://www.wpc-edi.com/. The six HL7 following Internet address: http:// pathology, or other examinations of
AIS documents are: www.regenstrief.org/loinc/loinc.htm. materials from the human body.
(i) Ambulance services information: Users without access to the Internet may Medications means those drugs and
The CDAR1AIS0001R021 Additional obtain the LOINC database from the biologics that the individual is already
taking, that are ordered for the transaction using electronic media, must Medications Attachment, Release 2.1,
individual during the course of submit complete requests and identify based on HL7 CDA Release 1.0
treatment, or that are ordered for an in the transaction, all of the attachment (incorporated by reference in §162.920).
individual after treatment has been information needed to adjudicate the
furnished. claim, which can be requested by means § 162.1920 Electronic health care claims
attachment response transaction.
Rehabilitation services means those of the transaction.
therapy services provided for the (d) The health care claims attachment (a) The health care claims attachment
primary purpose of assisting in an request transaction sent using electronic response transaction is the transmission
individual’s rehabilitation program of media, is comprised of two component of attachment information, from a health
evaluation and services. These services parts: care provider to a health plan, in
are: Cardiac rehabilitation, medical (1) The general request structure that response to a request from the health
social services, occupational therapy, identifies the related claim; and plan for the information.
physical therapy, respiratory therapy, (2) The LOINC codes and LOINC (b) If a health care provider conducts
skilled nursing, speech therapy, modifiers identifying the attachment a health care claims attachment
psychiatric rehabilitation, and alcohol information being requested. transaction using electronic media, and
and substance abuse rehabilitation. the attachment information is of the
§ 162.1915 Standards and implementation type described at §162.1905, the health
§ 162.1905 Requirements for covered specifications for the electronic health care care provider must conduct the
entities. claims attachment request transaction. transaction in accordance with the
When using electronic media to The Secretary adopts the following appropriate provisions of §162.1925.
conduct a health care claims attachment standards and implementation (c) A health care provider that
request transaction or a health care specifications for the electronic health conducts a health care claims
claims attachment response transaction, care claims attachment request attachment response transaction using
a covered entity must comply with the transaction: electronic media must submit a
applicable standards of this subpart if: (a) The ASC X12N 277—Health Care complete response by providing, to the
(a) Information not contained in a Claim Request for Additional extent available, all of the requested
health care claim is needed for the Information, Version 4050, May 2004, attachment information or other
adjudication of that health care claim; Washington Publishing Company, appropriate response in the transaction.
and 004050X150 (incorporated by reference (d) A health care provider that sends
(b) The health care claim is for one or in §162.920). scanned images and text documents in
more of the following types of services: (b) The following HL7 AIS documents the attachment transaction, for the
(1) Ambulance services; to convey the LOINC codes that human decision variants, is not required
(2) Emergency department services; identify the attachment type and to use the LOINC codes as the
(3) Rehabilitation services; or specific information being requested— response, other than to repeat the
(c) The additional information (1) Ambulance services information: LOINC codes used in the request.
requested is for one or more of the The CDAR1AIS0001R021 Additional Response information may be free text,
following types of information: Information Specification 0001,
(1) Clinical reports; scanned documents, or an embedded
Ambulance Service Attachment, Release document within the BIN segment of the
(2) Laboratory results; or 2.1, based on HL7 CDA Release 1.0
(3) Medications. response transaction.
(incorporated by reference in §162.920); (e) A health care provider may submit
§ 162.1910 Electronic health care claims (2) Emergency department an unsolicited response transaction only
attachment request transaction. information: The CDAR1AIS0002R021 upon advance instructions by a health
(a) The health care claims attachment Additional Information Specification plan.
request transaction is the transmission, 0002: Emergency Department
from a health plan to a health care Attachment, Release 2.1, based on HL7 § 162.1925 Standards and implementation
CDA Release 1.0 (incorporated by specifications for the electronic health care
provider, of a request for attachment
reference in §162.920); claims attachment response transaction.
information to support the adjudication
of a specific health care claim. A health (3) Rehabilitation services The Secretary adopts the following
plan may make such a request— information: The CDAR1AIS0003R021. standards and implementation
(1) Upon receipt of the health care Additional Information Specification specifications for the electronic health
claim; 0003: Rehabilitation Services care claims attachment response trans
(2) In advance of submission of the Attachment, Release 2.1, based on HL7 action:
health care claim; or CDA Release 1.0 (incorporated by (a) The ASC X12N 275—Additional
(3) Through instructions for a specific reference in §162.920); Information to Support a Health Care
type of health care claim which permit (4) Clinical reports information: The Claim or Encounter, Version 4050, May
a health care provider to submit CDAR1AIS0004R021 Additional 2004, Washington Publishing Company,
attachment information on an Information Specification 0004: Clinical 004050X151 (incorporated by reference
unsolicited basis each time such type of Reports Attachment, Release 2.1, based in §162.920).
claim is submitted. on HL7 CDA Release 1.0 (incorporated (b) The HL7 Additional Information
(b) If a health plan conducts a health by reference in §162.920); Specification Implementation Guide
care claims attachment request (5) Laboratory results information: Release 2.1 (incorporated by reference
transaction using electronic media and The CDAR1AIS0005R021 Additional in §162.920) for implementing the HL7
the attachment information requested is Information Specification 0005: Additional Information Specifications to
of a type described at §162.1905 , the Laboratory Results Attachment, Release convey attachment information within
plan must conduct the transaction in 2.1, based on HL7 CDA Release 1.0 the Binary Data segment of the ASC
accordance with the appropriate (incorporated by reference in §162.920). X12N 275 (004050x151).
provisions of §162.1915. (6) Medications information: The (c) The following HL7 AIS documents
(c) A health plan that conducts a CDAR1AIS0006R021 Additional to convey the LOINC codes that
health care claims attachment request Information Specification 0006: identify the attachment type and
specific attachment information being on HL7 CDA Release 1.0 (incorporated (b) Health plans. A health plan must
sent— by reference in §162.920); comply with the applicable
(1) Ambulance Services information: (5) Laboratory results information: requirements of this subpart S no later
The CDAR1AIS0001R021 Additional The CDAR1AIS0005R021 Additional than one of the following dates:
Information Specification 0001: Information Specification 0005: (1) Health plans other than small
Ambulance Service Attachment, Release Laboratory Results Attachment, Release health plans—[24 months after the
2.1, based on HL7 CDA Release 1.0 2.1, based on HL7 CDA Release 1.0 effective date of the final rule published
(incorporated by reference in §162.920); (incorporated by reference in §162.920); in the Federal Register].
(2) Emergency Department and (2) Small health plans—[36 months
information: The CDAR1AIS0002R021 (6) Medications information: The after the effective date of the final rule
Additional Information Specification CDAR1AIS0006R021 Additional published in the Federal Register].
0002: Emergency Department Information Specification 0006: (c) Health care clearinghouses. A
Attachment, Release 2.1, based on HL7 Medications Attachment, Release 2.1, health care clearinghouse must comply
CDA Release 1.0 (incorporated by based on HL7 CDA Release 1.0 with the applicable requirements of this
reference in §162.920); (incorporated by reference in §162.920). subpart S no later than [24 months after
(3) Rehabilitation services the effective date of the final rule
information: The CDAR1AIS0003R021 § 162.1930 Initial compliance dates for the published in the Federal Register].
Additional Information Specification electronic health care claims attachment
response and electronic health care claims Authority: Sections 1173 and 1175 of the
0003: Rehabilitation Services Social Security Act (42 U.S.C. 1320d–2 and
Attachment, Release 2.1, based on HL7 attachment request transaction standards.
1320d–4).
CDA Release 1.0 (incorporated by (a) Health care providers. A covered
health care provider must comply with Dated: May 27, 2005.
reference in §162.920);
(4) Clinical reports information: The the applicable requirements of this Michael O. Leavitt,
CDAR1AIS0004R021 Additional subpart S no later than [24 months after Secretary.
Information Specification 0004: Clinical the effective date of the final rule [FR Doc. 05–18927 Filed 9–22–05; 8:45 am]
Reports Attachment, Release 2.1, based published in the Federal Register]. BILLING CODE 4120–01–P

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Proposed Rule: Medicare and Medicaid: Health Insurance Portability and Accountability Act Implementation&#8212 Electronic Health Care Claims Attachments Standards

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Friday,

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45 CFR Part 162

DEMONSTRATION OF HOW XML IS USED WITHIN A CDA DOCUMENT

<level one> ......................................................... Outermost tag, contains an entire CDA document.

TABLE 1.—HUMAN VS. COMPUTER VARIANTS FOR ELECTRONIC ATTACHMENTS

............................................................. R4:436:3F ................................... R4 = Requests for additional information/

............................................................. R4:437:3F ................................... R4 = Requests for additional information/

TABLE 3.—FIVE YEAR COSTS FROM TRANSACTIONS RULE

Costs 2007 2008 2009 2010 2011

TABLE 4.—TOTAL HEALTH CARE CLAIMS—PHYSICIANS AND HOSPITALS

TABLE 5.—TOTAL HEALTH CARE CLAIMS ATTACHMENTS—PHYSICIANS AND HOSPITALS

2007 2008 2009 2010 2011

Attachments volume: 50 percent of the estimated 25 per-

2007 2008 2009 2010 2011

2007 2008 2009 2010 2011

Total savings Total savings Annualized savings Annualized savings

Low High Low High Low High Low High

Total Operational Savings Achieved Using

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