HIPAA Administrative Simplification: Standards for Electronic Health Care Claims Attachments, 55990-56025 [05-18927]

Agencies

• Office of the Secretary
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Proposed Rules]
[Pages 55990-56025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18927]



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Part III





Department of Health and Human Services





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Office of the Secretary



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45 CFR Part 162



HIPAA Administrative Simplification: Standards for Electronic Health 
Care Claims Attachments; Proposed Rule

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 162

[CMS-0050-P]
RIN 0938-AK62


HIPAA Administrative Simplification: Standards for Electronic 
Health Care Claims Attachments

AGENCY: Office of the Secretary, HHS.

ACTION: Proposed rule.

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SUMMARY: This rule proposes standards for electronically requesting and 
supplying particular types of additional health care information in the 
form of an electronic attachment to support submitted health care 
claims data. It would implement some of the requirements of the 
Administrative Simplification subtitle of the Health Insurance 
Portability and Accountability Act of 1996.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on November 22, 
2005.

ADDRESSES: In commenting, please refer to file code CMS-0050-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to https://www.cms.hhs.gov/regulations/
ecomments. Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY:
    Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-0050-P, P.O. Box 8014, Baltimore, MD 
21244-8014.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address ONLY: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-0050-P, Mail Stop C4-26-05, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the addresses above or below. If 
you intend to deliver your comments to the Baltimore address, please 
call (410) 786-7195 in advance to schedule your arrival with one of our 
staff members.
    Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, 
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 
21244-1850.
    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Lorraine Tunis Doo, (410) 786-6597.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on all issues set forth in this proposed rule to assist 
us in fully considering issues and developing policies. You can assist 
us by referencing the file code [CMS-0050-P] and the specific ``issue 
identifier'' that precedes the section on which you choose to comment.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. CMS posts all comments 
received before the close of the comment period on its public Web site 
as soon as possible after they have been received. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, at the headquarters of the Centers for Medicare & Medicaid 
Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850, 
Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule 
an appointment to view public comments, phone 1-800-743-3951.

Table of Contents

I. Background
    A. Summary
    B. Legislation
    C. Standards Setting Organizations
    1. Accredited Standards Committee X12 (ASC X12)
    2. Health Level Seven (HL7)
    D. Industry Standards, Implementation Guides and Additional 
Information Specifications
    1. ASC X12N and the HL7 Implementation Guides and HL7 Additional 
Information Specifications
    2. Implementation Guides in HIPAA Regulations
II. Provisions of the Proposed Regulations
    A. Definitions
    1. Ambulance Services
    2. Attachment Information
    3. Clinical Reports
    4. Emergency Department
    5. Laboratory Results
    6. Logical Observation Identifiers Names and Codes 
(LOINC[supreg]))
    7. Medications
    8. Rehabilitation Services
    B. Effective Dates
    C. Overview of Key Information for Electronic Health Care Claims 
Attachments
    1. Overview of Extensible Markup Language (XML)
    2. Overview of Clinical Document Architecture
    3. How XML Is Applied Within the Clinical Document Architecture
    4. Transactions for Transmitting Electronic Attachments
    5. Electronic Claims Attachment Types
    6. Format Options (Human vs. Computer Variants) for Electronic 
Claims Attachments
    7. Combined Use of Two Different Standards Through Standard 
Development Organization (SDO) Collaboration
    D. Electronic Health Care Claims Attachment Business Use
    1. Electronic Health Care Claims Attachment vs. Health Care 
Claims Data
    2. Solicited vs. Unsolicited Electronic Health Care Claims 
Attachments
    3. Coordination of Benefits
    4. Impact of Privacy Rule
    5. Impact of the Security Rule
    6. Connection to Signatures (Hard Copy and Electronic)
    7. Connection to Consolidated Health Informatics Initiative
    8. Health Care Provider vs. Health Plan Perspective
    9. Health Care Clearinghouse Perspective
    E. Electronic Health Care Claims Attachment Content and 
Structure
    F. Alternatives Considered: Candidate Standards for Transaction 
Types and Code Sets
    1. Transactions
    a. Health Care Claims Attachment Request Transaction
    b. Health Care Claims Attachment Response Transaction
    2. Code Sets
    3. Implementation Specifications for Sending and Receiving 
Additional Health Care Information within a Transaction
    G. Proposed Standards
    1. Code Set
    2. Electronic Health Care Claims Attachment Request Transaction

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    3. Electronic Health Care Claims Attachment Response Transaction
    4. Examples of How Electronic Health Care Claims Attachments 
Could Be Implemented
    a. Use of the Proposed Transactions Specifications, and Codes 
for Electronic Health Care Claims Attachments
    b. White Paper from HL7
    H. Requirements (Health Plans, Covered Health Care Providers and 
Health Care Clearinghouses)
    1. Additional Information Specification (AIS) Uses: Attachment 
Types That May Be Used for Any Service
    a. Clinical Reports
    b. Laboratory Results
    c. Medications
    2. Additional Information Specification (AIS) Uses: Attachment 
Types for Specific Services
    a. Rehabilitation Services
    b. Ambulance Service
    c. Emergency Department
    3. Maximum Data Set
    I. Specific Documents and Sources
III. Modifications to Standards and New Electronic Attachments
    A. Modifications to Standards
    B. Additional Information Specifications for New Electronic 
Attachments
    C. Use of Proposed and New Electronic Attachment Types Before 
Formal Approval and Adoption
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
    A. Overall Impact
    1. Affected Entities (Covered Entities)
    2. Effects of Various Options
    B. Cost and Benefit Analysis
    1. General Assumptions, Limitations, and Scope
    2. Cost and Benefit Analysis for Health Plans
    3. Cost and Benefit Analysis for Health Care Providers
    4. Cost and Benefit Estimates
    a. Costs of Implementation
    b. Benefits of Implementation
    5. Conclusions
    C. Guiding Principles for Standard Selection
    1. Overview
    2. General
Regulations Text

I. Background

A. Summary

    This proposed rule recommends the adoption of a set of standards 
that will facilitate the electronic exchange of clinical and 
administrative data to further improve the claims adjudication process 
when additional documentation (also known as health care claim 
attachments) is required. This rule proposes two X12N transaction 
standards to be used--one to request the information and one to respond 
to that request with the answers or additional information. This rule 
also proposes the use of Health Level 7 (HL7) specifications for the 
content and format of communicating the actual clinical information. 
And finally, this rule proposes the adoption of the Logical Observation 
Identifiers Names and Codes, or LOINC[supreg] for specific 
identification of the additional information being requested, and the 
coded answers which respond to the requests. The combination of the 
X12N and HL7 standards for purposes of these transactions is proposed 
because the X12N standards are standards for exchanging administrative 
information, and the HL7 standards are standards for exchanging 
clinical information; the marriage of these standards for the 
electronic health care claims attachment transactions uses the 
capabilities and advantages of each type of standard. The LOINC[supreg] 
code set already has the most robust set of codes for laboratory 
results and clinical reports, and now includes the codes for the 
attachment ``questions'' or requests proposed in this rule.
    Electronic data interchange (EDI) is the electronic transfer of 
information (such as electronic health care claims and supplemental 
information) in a standard format. EDI allows entities within the 
health care system to exchange medical, billing, and other information 
to process transactions in a more expedient and cost effective manner. 
Use of EDI reduces handling and processing time and eliminates the risk 
of lost paper documents. EDI can therefore reduce administrative 
burdens, lower operating costs, and improve overall data quality.
    The health care industry already recognizes the benefits of EDI, 
and there has been a steady increase in its use over the past decade. 
In fact, for many years, health plans have been encouraging their 
health care providers to move toward electronic transmissions of claims 
and inquiries, both directly and through third parties such as health 
care clearinghouses, but the transition has been inconsistent across 
the board. It is assumed that the absence of standardization has made 
it difficult to encourage widespread increases in EDI and to develop 
software that could be employed by multiple users. The Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 (Pub. L. 104-191, 
enacted on August 21, 1996) Transaction Rule standards, with entity 
type specific compliance dates in October of either 2002 or 2003, 
addressed that lack of standardization in the health care industry. 
Just as experience and process improvements have grown with EDI, 
experience with the standard transactions and automation will result in 
additional efficiencies and savings for both health care providers and 
health plans.
    The expectation, when standard national EDI formats and data 
content for health care transactions were adopted, was that the 
administrative burdens on health plans, health care providers, and 
their billing services would decrease. A standard EDI format allows 
data interchange using a common interchange structure, thus eliminating 
the need for users to program their data processing systems to 
accommodate multiple formats. Standardization of the interchange 
structure also involves specification of which data elements are to be 
exchanged; uniform definitions of those specific data elements in each 
type of electronic transaction; and identification of the specific 
codes or values that are valid for each data element.

B. Legislation

    Through subtitle F of title II of HIPAA, the Congress added to 
title XI of the Social Security Act (``the Act'') a new subpart C, 
entitled ``Administrative Simplification.'' HIPAA affects several 
titles in the United States Code. Throughout this proposed rule, we 
refer to the Social Security Act as ``the Act,'' and we refer to the 
other laws cited in this document by their names. One purpose of 
subtitle F was to improve the efficiency and effectiveness of the 
health care system in general by encouraging the development of a more 
automated health information system through the establishment of 
standards and requirements to facilitate the electronic transmission of 
certain health information. The Congress included provisions to address 
the need for supplemental health care claim information in the form of 
electronic attachments to claims.
    Part C of title XI consists of sections 1171 through 1179 of the 
Act. These sections define various terms and impose requirements on the 
Department of Health and Human Services (HHS), health plans, health 
care clearinghouses, and certain health care providers, concerning the 
conduct of electronic transactions, among other things.
    HIPAA was discussed in greater detail in Standards for Electronic 
Transactions (65 FR 50312), published on August 17, 2000 (Transactions 
Rule), and the Standards for Privacy of Individually Identifiable 
Health Information (65 FR 82462), published on December 28, 2000 
(Privacy Rule). Rather than repeating the discussion here, the reader 
is referred to those documents for further information. Specific 
information is provided in those

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documents on the content of each section of HIPAA (for example, they 
explain that section 1173 of the Act requires the Secretary to adopt 
standards for transactions and data elements to be included in covered 
transactions; section 1174 of the Act describes the timetable for 
establishing standards and for compliance with those standards; 
sections 1176 and 1177 of the Act establish penalties for violations of 
the established standards; and so forth).
    Two provisions of the Act are particularly relevant to the 
electronic health care claims attachment standards being presented 
here:
     Section 1172 of the Act contains requirements concerning 
standard setting. It states that the Secretary must adopt a standard 
developed, adopted, or modified by a standard setting organization 
(that is, a standard setting organization accredited by the American 
National Standards Institute (ANSI) that develops standards for 
transactions or data elements) after consulting with the National 
Uniform Billing Committee (NUBC), the National Uniform Claim Committee 
(NUCC), Workgroup for Electronic Data Interchange (WEDI), and the 
American Dental Association (ADA), assuming there is a suitable 
standard.
     Section 1173(a)(2)(B) identifies a health claim attachment 
[sic] as one transaction for which electronic standards are to be 
adopted.

C. Standards Setting Organizations

    ANSI accredits organizations to develop standards under the 
condition that procedures used to develop and approve the standards 
meet certain due process requirements and that the process is 
voluntary, open, and based on obtaining consensus. These accredited 
organizations are referred to by ANSI as Accredited Standards 
Developer(s) (ASD) or Standards Development Organization(s)(SDO). The 
standards for the transactions proposed in this rule come from two such 
accredited organizations, Accredited Standards Committee X12 (ASC X12) 
and Health Level Seven (HL7).
1. Accredited Standards Committee X12
    The Accredited Standards Committee X12 (ASC X12) is the SDO 
accredited by ANSI to design national electronic standards for a wide 
range of administrative and business applications across many 
industries. ASC X12 membership is open to all individuals and 
organizations. A subcommittee of ASC X12, ASC X12N, develops electronic 
standards specific to the insurance industry, including health care 
insurance. Volunteer members of the ASC X12N subcommittee, including 
health care providers, health plans, bankers, and vendors involved in 
software development and billing/transmission of health care data, as 
well as organizations involved in other business aspects of health care 
administrative activities, worked together to develop standards for 
electronic health care transactions. These standards included 
transactions for common administrative activities: claims, remittance 
advice, claims status, enrollment, eligibility, and authorizations and 
referrals. Within ASC X12N, Workgroup 9: Patient Information (WG9) 
undertook the tasks associated with evaluating appropriate standards 
for electronic health care claims attachments. The WG9 workgroup is 
comprised of representatives from private and government insurers, 
software vendors, health care clearinghouses, State and Federal 
agencies, health insurance standards organizations, and provider 
associations.
2. Health Level Seven
    HL7 is a not-for-profit, ANSI-accredited SDO that provides 
standards for the exchange, management, and integration of data that 
support clinical patient care and the management, delivery, and 
evaluation of health care services. While other standards development 
or standard setting organizations create standards or protocols to meet 
the business needs of a particular healthcare domain such as pharmacy, 
medical devices, or insurance, HL7's domain is principally clinical 
data. Its specific emphasis is on the interoperability between 
healthcare information systems. In fact, ``Level Seven'' refers to the 
highest level of the International Standards Organization's 
communications model for Open Systems Interconnection--which is the 
application level of a system. The application level addresses the 
definition of the data to be exchanged, the timing of the interchange, 
and the communication of certain errors to the application. The seventh 
level supports such functions as security checks, participant 
identification, availability checks, exchange mechanism negotiations, 
and most significantly, data exchange structuring. HL7 is in a unique 
position to participate in standard setting for health information 
because its focus is on the interface requirements of the entire health 
care organization rather than on a particular domain.
    HL7 membership is open to all individuals and organizations. Within 
HL7, similar to Work Group 9 under X12N, the Attachments Special 
Interest Group (ASIG) includes industry experts representing health 
care providers, health plans, and vendors, and is dedicated to 
developing the criteria and standards for electronic health care claims 
attachments. This group created the Additional Information 
Specifications (AIS) referenced in this proposed rule. The ASIG is 
responsible for those tasks associated with creating and maintaining 
the documents that specify the content, format and codes for submitting 
and responding to requests for each type of electronic health care 
claims attachment. These documents are known as AIS, which again, are 
each a set of instructions and associated code tables created and 
maintained by HL7 that describes, lists, or itemizes the additional 
information that is to be sent and how such information is to be 
conveyed in an electronic health care claims attachment.

D. Industry Standards, Implementation Guides, and Additional 
Information Specifications

1. ASC X12N and the HL7 Implementation Guides and HL7 Additional 
Information Specifications
    ASC X12N: The ASC X12 Subcommittee N: Insurance (ASC X12N) 
publishes documented specifications for standard data interchange 
structures (message transmission formats) that apply to various 
business needs. For example, the X12N 820 transaction standard for 
premium payment can be used to submit payment for automobile insurance 
or casualty insurance, as well as for health insurance. The X12N 820 
was adopted as one of the standards under HIPAA for premium payments 
from an employer or group health plan to the insurer or health plan. In 
order to make these general standards functional for industry-specific 
uses, it became critical to develop implementation specifications. 
These specifications, referred to by the industry as ``implementation 
guides,'' are based upon ASC X12 standards and contain the detailed 
instructions developed by ASC X12N for using a specific transaction to 
meet a specific business need. Each ASC X12N implementation guide has a 
unique version identification number (for example, 004010, 004050, or 
005010) where the highest version number represents the most recent 
version. Implementation Guides are written collaboratively by X12N 
workgroups, and are voted upon as described below.
    The ASC X12 committee is the decision-making body responsible for

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obtaining consensus from the entire organization, which is necessary 
before seeking ANSI approval of a standard in the field of health 
insurance. The ASC X12N Subcommittee develops standards and conducts 
maintenance activities. The draft documents are made available for 
public review and comment. After the comments are addressed, the 
revised document is presented to the entire ASC X12N subcommittee 
membership group for approval. This work is then reviewed and approved 
by the membership of ASC X12 as a whole. In sum, Implementation Guides 
developed by ASC X12N must be ratified by a majority of voting members 
of the ASC X12N subcommittee and the executive committee of X12 itself.
    HL7: To establish its standards, HL7 conducts a three-step process. 
First, standards are developed and accepted or rejected by voting at 
the technical committee level. All HL7 members are eligible to vote on 
standards, without regard to whether they are members of the committee 
that wrote the standard. Non-members may also vote on a given ballot 
for a standard, for which privilege they pay an administrative fee. 
HL7's policy states that it shall assess an administrative fee for the 
processing, handling, and shipping of the ballot package. The 
administrative fee does not exceed the fee associated with an 
individual membership in HL7. Second, HL7 technical committees and 
special interest groups vote on ``recommendations'' and at least two-
thirds of the total votes must be positive for approval. Third, if 
approved at the technical committee level, the recommended standards 
are submitted to the entire HL7 organization for approval. Finally, 
they are submitted to ANSI for certification.
2. Implementation Guides in HIPAA Regulations
    Section 1172(d) of the Act directs the Secretary to establish 
specifications for implementing each of the standards adopted under 
this part.
    For electronic transaction standards, the SDOs developed 
``Implementation Guides'' for implementing the same standards for a 
number of different business purposes. For example, the general ASC X12 
claim, the 837, has separate implementation guides that permit its use 
in automobile, liability, and health care claims. The approach taken in 
the final Transactions Rule was to adopt a specific ``Implementation 
Guide'' as both the ``standard'' and the ``implementation 
specifications'' for each health care transaction.
    The regulations text of this proposed rule also adopts the 
referenced guides as both the standard and the implementation 
specifications for each electronic health care claim attachment 
transaction. Accordingly, this rule proposes the adoption of specific 
X12 Implementation Guides (for example, the ASC X12N 277 version 4050) 
as both the standard and the implementation specification for each 
transaction. To avoid confusion in the use of certain similar terms in 
this proposed rule, we use the term ``Implementation Guide'' only when 
referring to specific documents published by ASC X12N. Therefore, when 
we refer to the master HL7 Implementation Guide, we will state the full 
document name: ``HL7 Additional Information Specification 
Implementation Guide,'' or HL7 AIS IG. We do not otherwise refer to 
``implementation specifications'' or distinguish between ``standards'' 
and ``implementation specifications.''
    The 4050 versions of the X12 Implementation Guides are compatible 
with the current X12 4010 guides adopted for HIPAA transactions--
version 4010-1a so that the two transactions can be used together as 
necessary. In other words, a claims transaction (837 version 4010-1a) 
may be accompanied by a health care claims attachment response 
transaction (275 version 4050). Public comments on the draft versions 
of the X12 Implementation Guides for version 4050 of the X12N 277 and 
X12N 275 were solicited between December 5, 2003 and January 9, 2004. 
The current guides may be obtained from https://www.wpc-edi.com.
    The other set of documents proposed for use with electronic health 
care claims attachments are called HL7 Additional Information 
Specifications (AIS). These were drafted by the HL7 ASIG work group and 
were balloted and approved by HL7 in September 2003. These AIS are used 
in concert with the X12 Implementation Guides and provide the 
instructions for the use of the proposed code set, to be described 
later in this preamble. The adoption of the HL7 documents would fulfill 
the legal mandate for the Secretary to establish the implementation 
specifications for the HIPAA standards proposed for adoption in 
accordance with 1172(d) of the Act.
    The X12N Implementation Guides, HL7 AIS IG, HL7 AIS, and the 
LOINC[supreg] code set proposed for adoption in this proposed rule, are 
all copyrighted by their respective organizations, and each document 
includes a copyright statement. The copyright protection ensures the 
integrity of the materials and provides appropriate attribution to the 
developers. The materials are all available at no charge. Later in this 
preamble and in the regulations themselves, we provide the mailing 
addresses and Internet sites for the documents so that readers can 
obtain them in a convenient manner that will allow for their review, 
along with this proposed rule.

II. Provisions of the Proposed Regulations

    This proposed rule describes requirements that health plans, 
covered health care providers, and health care clearinghouses would 
have to meet to comply with the statutory requirement to use a standard 
for electronic health care claims attachment transactions, and to 
facilitate the transmission of certain types of detailed clinical 
information to support an electronic health care claim.
    In the final Transactions Rule, new parts 160 and 162 were added to 
title 45 of the Code of Federal Regulations (65 FR 50365). The 
provisions in this proposed rule would be placed in a new subpart S of 
part 162 which would contain provisions specific to the electronic 
health care claims attachment standards. The provisions of this new 
subpart can be implemented consistently with the provisions of the 
HIPAA Privacy Rule and Security Rule, which are codified mainly at 
subparts A, C, and E of part 164 of title 45 of the Code of Federal 
Regulations.

A. Definitions

    [If you choose to comment on issues in this section, please include 
the caption ``DEFINITIONS'' at the beginning of your comments.]
    Section 1171 of the Act defines several terms. The definitions set 
out in section 1171 of the Act and regulations at 45 CFR part 160 and 
subpart A of part 162 would also apply to the electronic health care 
claims attachment standards. There are also several new terms and 
definitions proposed that are related to the standards proposed in this 
rule, (see proposed Sec. 162.103 and Sec. 162.1900). The new terms, 
their definitions and examples or explanations thereof are as follow:
    1. Ambulance Services means health care services provided by land, 
water, or air transport, and the procedures and supplies used during 
the trip by the transport personnel, to assess, treat or monitor the 
individual until arrival at the hospital, emergency department, home or 
other destination. Ambulance documentation may also include non-
clinical information such as the destination justification and ordering 
practitioner.
    2. Attachment Information means the supplemental health information

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needed to support a specific health care claim. The health care claim 
attachment information is conveyed using both an X12 transaction and 
HL7 specification.
    3. Clinical Reports means reports, studies, or notes, including 
tests, procedures, and other clinical results, used to analyze and/or 
document an individual's medical condition. These include discharge 
summaries, operative notes, history, physicals, and diagnostic 
procedures (radiology reports, electrocardiogram (for example, EKG), 
cardiac echoes, gastrointestinal tests, pathology, etc.) Clinical 
reports do not include psychotherapy notes.
    4. Emergency department means a health care facility or department 
of a hospital that provides acute medical and surgical care and 
services on an ambulatory basis to individuals who require immediate 
care primarily in critical or life-threatening situations.
    5. Laboratory Results means the clinical information resulting from 
tests conducted by entities furnishing biological, microbiological, 
serological, chemical, immunohematological, hematological, biophysical, 
cytological, pathology, or other examinations of materials from the 
human body. Laboratory results are used for the diagnosis, prevention, 
or treatment of any disease or impairment of, or assessment of, the 
health of the individual. Laboratory results are generated from the 
services provided in a laboratory or other facility that conducts those 
tests and examinations.
    6. LOINC stands for Logical Observation Identifiers Names and Codes 
(LOINC[supreg]). It is a code set that provides a standard set of 
universal names and codes for identifying individual laboratory and 
clinical results as well as other clinical information. LOINC[supreg] 
codes are developed and maintained by the LOINC[supreg] committee and 
copyrighted 1995-2004, by Regenstrief Institute, Inc., and the Logical 
Observation Identifiers Names and Codes (LOINC[supreg]) Committee.
    7. Medications means those drugs and biologics that the individual 
is already taking, that are ordered for the individual during the 
course of treatment, or that are ordered for an individual after 
treatment has been furnished. Medications include drugs and biologics 
that are ordered by a licensed practitioner, or that are being taken by 
the individual, independent of a health care provider's orders (for 
example, over-the-counter drugs). In the AIS documents, these are 
referred to as ``current medications,'' ``medications administered,'' 
and ``discharge medications.'' Current medications are those the 
individual is taking before an encounter that generates a new claim; 
medications administered are those given to the individual by a health 
care provider during the encounter; and discharge medications are those 
that the health care provider orders for the individual to take and use 
after release or discharge from the encounter, including the 
medications the individual may already have at home or those he or she 
may need to obtain following treatment.
    8. Rehabilitation services means those therapy services provided 
for the primary purpose of assisting in an individual's rehabilitation 
program of evaluation and services. These services are: Cardiac 
rehabilitation, medical social services, occupational therapy, physical 
therapy, respiratory therapy, skilled nursing, speech therapy, 
psychiatric rehabilitation, and alcohol and substance abuse 
rehabilitation.

B. Effective Dates

    [If you choose to comment on issues in this section, please include 
the caption ``EFFECTIVE DATES'' at the beginning of your comments.]
    Covered entities must comply with the standards for electronic 
health care claims attachments 24 months from the effective date of the 
final rule unless they are small health plans. Small health plans will 
have 36 months from the effective date of the final rule to come into 
compliance.

C. Overview of Key Information for Electronic Health Care Claims 
Attachments

    For the remainder of this document, we will use the terms 
electronic claims attachments or electronic attachments to mean the 
same thing as electronic health care claims attachments. Similarly, the 
term Additional Information Specification may be referred to as an 
attachment specification or an AIS, and these terms are used 
interchangeably throughout the text. Since the term ``Implementation 
Guide'' is used by both HL7 and X12, we therefore use the full title 
for each document when they are referenced, such as the ``HL7 
Additional Information Specification Implementation Guide.''
    This rule proposes to establish standards for electronic health 
care claims attachments. The proposed rule is specific to electronic 
health care claims attachments rather than paper attachments (hard copy 
medical records), since the purpose of the HIPAA administrative 
simplification provisions is to facilitate the development of a 
national electronic health information system. Standard electronic 
health care claims attachments will allow for the electronic exchange 
of additional clinical and administrative information to augment the 
HIPAA standard claim transaction.
    The goal of having a more automated, standardized approach to the 
exchange of information in the health care industry is longstanding. In 
1994, the Workgroup for Electronic Data Interchange (WEDI) conducted a 
survey of the U.S. health care industry and documented its findings in 
a paper entitled: WEDI Attachments Workgroup Report, Initial Findings. 
Among other issues, this study examined the state of the health care 
industry as it related to the use of, and need for, electronic health 
care claims attachments standards. The survey identified hundreds of 
different paper-based attachments formats being used with health care 
claims. The attachments and their formats ranged from simple to complex 
and varied according to the type of information being requested, the 
services involved, and who was asking for the information. The WEDI 
report concluded with a set of recommendations, including the 
development of an electronic standard for exchanging this type of 
information between health care providers and health plans. Key among 
the recommendations were that: (a) Standardized data elements should be 
created for electronic claims attachments; (b) collaboration between 
affected entities should be encouraged; (c) standard ways to link data 
across transaction sets should be developed; and (d) a transaction set 
(pair of transactions) should be selected to send and respond to 
requests for additional information (similar to the health care claims 
status request and response transactions--the X12N 276/277 pair).
    CMS's work in the mid-1990s with WEDI, ASC X12, and HL7 resulted in 
the recommendation to use an HL7 version 2.4 message embedded within 
version 3040 of the ASC X12N 275 ``Additional Information to Support a 
Health Care Claim or Encounter Transaction,'' in other words, a 
response to a request for information. The embedded HL7 message would 
have contained structured and codified attachment data using the 
LOINC[supreg] coding system. For a variety of reasons, a proposed rule 
was never released with this recommendation. Since that time, HL7 moved 
ahead with development of its Clinical Document Architecture (CDA), 
which was a significant enhancement over the HL7 version 2.4 messaging. 
The CDA Release 1.0, August 2003, is an XML-based

[[Page 55995]]

document specification that enables the standardization of ``clinical 
documents'' for electronic exchanges of health information (see 
explanation of XML below). The CDA became the first ANSI-accredited 
XML-based standard in the health care industry.
    There is increasing evidence that many health care organizations, 
including health plans, health care providers, and health care 
clearinghouses, plan on implementing more XML-based EDI tools. Thus, 
building electronic health care claims attachments using XML technology 
is in concert with the direction of the industry. In light of these 
developments, we believe that the timing for this proposed rule is 
reasonable because its publication and the years allowed for 
implementation should leave ample time for the industry to further 
develop its skills with XML and EDI exchange methodology.
    The HL7 standard being proposed here would allow the same records 
and data to be ``read'' and used by either people or computers. In 
other words, regardless of how the data are sent within the proposed 
transaction, they can be processed either manually or through 
automation. Furthermore, as entities move toward computer-based methods 
for adjudication, the costs of copying, coding, transcribing, storing, 
and processing records should begin to decrease. Thus, this proposal 
has the potential for helping the industry attain desired efficiencies, 
expedite payments, reduce fraud and abuse, and improve the accuracy of 
medical information.
1. Overview of Extensible Markup Language (XML)
    Extensible Markup Language, or XML, is a relatively new technology. 
It allows documents to be formatted and exchanged across the Internet 
or through EDI.
    Hypertext Markup Language (HTML) is a widely used presentation 
language used to create documents for display on the Web. Using HTML 
markup with text, links, and graphics creates an HTML document that is 
attractive in appearance. HTML was created to describe how the content 
of a page should be displayed, but not the actual contents of the page. 
XML fills this gap because it provides an intelligence to electronic 
documents and preserves both the content (the actual information) and 
semantics for the document, and also formats it attractively, similar 
to HTML. In fact, XML and HTML are increasingly used together--XML 
stores and organizes the data, while HTML renders it inside the browser 
or application.
    XML was originally published by the World Wide Web Consortium 
(https://www.w3c.org) and designed as a standard markup language to 
speed up and simplify data exchange and database connectivity and to 
enhance the creation of complex documents. XML effectively structures 
files into logical elements of information by the use and placement of 
tags which describe the kind of information being sent. Information 
organized using XML, and bounded by tags, is known as a document 
whether it is in a file, or whether it is being transmitted over the 
Internet or in any other technical environment. The process of 
arranging information between tags is called document markup.
    Over the past few years, XML has been adopted by most major 
companies in information technology as the basis for attaining 
interoperability among their own products. One of the special features 
of the XML family is the standard language for describing the 
transformation or conversion of an XML document into another format. 
Extensible Stylesheet Language, or XSL, is the language that contains 
the presentation format instructions for the document, similar to HTML. 
It allows the display of information in different media, such as a 
computer screen or a paper copy, and it enables the user to view the 
document according to his or her preferences and abilities, just by 
changing the stylesheet. XSL Version 1.0 is important because it can 
convert an XML document into Extensible HTML, which can be understood 
by current Web browsers and many common applications. In fact, each HL7 
AIS for the electronic claims attachment standards will include a fully 
functional XSL stylesheet for use by covered entities. If covered 
entities choose not to use the HL7 supplied stylesheet, they will be 
able to create their own without significant problems, assuming the 
expertise exists on staff or is available through a vendor.
2. Overview of Clinical Document Architecture
    The HL7 Clinical Document Architecture (CDA)--Release 1.0 was 
approved by HL7 in November 2000. It is a document markup standard 
encoded in XML that specifies the structure (format) and semantics 
(content) of ``clinical documents'' for the purpose of information 
exchange. These XML-coded documents have the same characteristics and 
information as hard copy clinical documents, and therefore can be 
processed by both people and machines. The clinical documents encoded 
in XML include a hierarchical set of document specifications (the 
architecture) and are rendered in human readable form using XSL. This 
makes them usable in either electronic or printed format. The XSL 
essentially translates the XML into a format that looks like a 
``regular'' plain text document.
    We are aware that HL7 continues to improve its standards, including 
the CDA. In fact, CDA Release 2.0 was first balloted in August 2003 and 
re-balloted in 2004. While Release 2.0 may be approved between the time 
of this proposed rule and the final rule, this proposed regulatory text 
does not suggest its adoption at this time. However, if Release 2.0 is 
approved by HL7 between the time of this proposed rule and the final 
rule, we may propose its adoption for future AIS, based on the impact 
of CDA Release 2.0 on the existing AIS. As part of CDA Release 2.0, HL7 
is developing an XSL stylesheet that would permit interoperability 
between Release 1.0 and Release 2.0. However, as this too is 
incomplete, it is premature to consider its use or viability at this 
time. We invite comment on the pros and cons of each CDA release, the 
issues related to the use of a stylesheet to permit use of either CDA 
release, and the costs and timing associated with implementing one 
release version over the other.
3. How XML Is Applied Within the Clinical Document Architecture
    As with any XML-based standard, the CDA defines tag names and how 
they nest to structure information. Some of the important tag names are 
shown in the table below. The indentation in the left column of the 
table shows the manner in which certain elements nest within other 
elements.

[[Page 55996]]



         Demonstration of How XML Is Used Within a CDA Document
------------------------------------------------------------------------
           Tag name                             Purpose
------------------------------------------------------------------------
..................  Outermost tag, contains an entire CDA
                                document.
.  Contains information about the document
                                arranged in subsections.
..........  Contains a code that identifies the
                                document type (for example, a discharge
                                summary or cardiac rehabilitation plan).
....................  Contains the name and identification
                                number of the patient (individual).
.......................  Contains the body of the report expressed
                                in natural language with optional
                                structured information.
....................  A subdivision of the body containing a
                                logical unit of information (for
                                example, the discharge medications).
....................  A subdivision of sections and other
                                elements that describes the contents
                                that will follow.
................  A subdivision of a caption that
                                identifies the contents that follow
                                using a LOINC[supreg] code.
------------------------------------------------------------------------
Source: HL7 white paper August 26, 2003. Specific to Release 1.0 of the
  CDA.

    An important feature of the CDA is that it allows the entire body 
of the XML document to be replaced by an actual image. The image might 
be a scanned copy of a page or pages from the medical record. The 
header is still present to support computer management of the document, 
but the clinical content can be conveyed entirely by an image or text 
document. This option is important to those health care providers that 
do not have a computer-based patient record system and cannot yet 
create electronic claims attachments in a structured format, but wish 
to reap some benefits from standardization and a certain level of 
automation.
4. Transactions for Transmitting Electronic Attachments
    As we describe in a later section entitled ``Candidates 
Considered,'' the standard setting organizations attempted to evaluate 
existing transactions for their potential to be used to send and 
receive attachment information electronically. Two transactions were 
ultimately selected because they only required modifications in a later 
version. In other words, while the existing X12N version 4010 standards 
did not satisfy the data content needs of the electronic health care 
claims attachments, revisions in version 4050 were made to accommodate 
these needs in time for this proposed rule. Thus, version 4050 of the 
X12N 277 ``request'' and version 4050 of the X12N 275 ``response'' are 
proposed to carry the attachment related questions and the related 
answers or responses. The X12N 277 version 4050 transaction transmits 
information about the particular claim in question and the question 
codes. The X12N 275 version 4050 transaction returns the claim 
identification (ID) information, and, in the Binary Data (BIN) segment, 
literally transports the responses to each question, with the response 
codes, narrative text, or actual imaged documents. The X12N 
transactions are flexible enough to accommodate the two format variants 
described in the next section, meaning the transaction can be used for 
either manual processing or computer automated processing.
5. Electronic Claims Attachment Types
    [If you choose to comment on issues in this section, please include 
the caption ``ELECTRONIC CLAIMS ATTACHMENT TYPES'' at the beginning of 
your comments.]
    While it might be considered ideal by some to have electronic 
attachments for all health care claims business needs, it would be 
virtually impossible to identify and create standard specifications 
with appropriate codes for the full array of different attachment types 
required today. Furthermore, given changes in industry business 
practices, and new adjudication rules over the past decade, it is more 
important to determine, from health care providers and health plans, 
which claims most commonly require additional information for 
adjudication today, and what types of electronic attachments might be 
required in the next 5 to 10 years. It is equally important for covered 
entities to gain experience with a manageable number of electronic 
attachment types at the outset, so that technical and business issues 
can be identified to improve the process with each new electronic 
attachment specification that is developed.
    While the attachment information needed to support the full range 
of health care claims may be diverse, the same general transaction 
structure and administrative information can be applied to all 
electronic claims attachments to allow for some level of consistency. 
This proposal to encourage some form of electronic transmission, even 
of a scanned document in the early stages of implementation, at least 
represents a methodical approach towards moving the industry from paper 
to electronic communication for health care claims attachments. The 
advantage of the more general X12N transaction standards that can serve 
as the vehicles to carry any type of electronic attachment information, 
is that they can be coupled with the specific attachment 
``documents''--coded or scanned--and remain available to handle new 
content-specific electronic attachment types as they are developed and 
approved.
    Based on industry feedback following implementation of the 
Transactions Rule, it became clear that pilot programs and early 
testing of new standards and processes were vital to the standards 
adoption process. In July 2004, HHS awarded funds for a Medicare pilot 
program to test the X12 request and response transactions, the 
LOINC[supreg] codes and at least two of the attachment types, using the 
HL7 Additional Information Specifications. The pilot is expected to 
demonstrate the capability of sending the X12 request transaction from 
a health plan to a health care provider, and then for the health care 
provider to send the X12 response, complete with the HL7 CDA in the BIN 
segment, back to the health plan. The health care provider will send 
both variants of each attachment type--a human variant (scanned 
document) and a computer variant (a coded response). These variants are 
described later in this preamble. We believe this pilot program will 
provide valuable insight as to the implementation challenges of 
electronic attachments, and perhaps even as to when health care 
providers and health plans could begin to move towards more structured, 
coded communication and adjudication. The SDOs are involved in the 
pilot as subject matter experts, so that as technical or operational 
challenges are identified with the standards, a core group of 
professionals with expertise can address them, and take corrective 
action on the X12 Implementation Guides, HL7 AIS or

[[Page 55997]]

LOINC[supreg] code set before the final rule is issued.
    In this proposed rule, we propose six specific electronic 
attachment types, each with data content requirements related to 
treatment or services provided. These six attachments are: (1) 
Ambulance services, (2) emergency department, (3) rehabilitation 
services, (4) clinical reports, (5) laboratory results, and (6) 
medications. These six specific attachments were originally selected 
for development because there was industry consensus on their relevance 
to a significant percentage of covered entities and to those claims 
that typically require additional documentation. They also contain the 
types of information commonly found in attachments, for example, 
narrative text (such as nurses' notes), simple data points (such as the 
results of a single laboratory test), and more complex information 
(such as rehabilitation progress over time). In 2003, the HL7 ASIG work 
group began working on other electronic claim attachment specifications 
that were identified by the industry as being significant, including 
home health, periodontal care, and durable medical equipment (DME).
    Comments are invited as to whether the six proposed attachment 
types are still the most frequently requested by health plans, and if 
there are others that are equally or more pressing for the industry.
    In the future, any new electronic attachment types, or changes to 
the six attachments standards proposed here, would require the 
Department to follow the usual rulemaking process. If changes are 
requested of the six proposed attachments standards, as a result of 
public comments during the period between the proposed and final rule, 
it is highly likely that HL7 would be able to make and ballot such 
changes in time for their adoption in the final rule. New electronic 
attachment standards approved by the SDO but not adopted by the 
Department may be used on a voluntary basis between trading partners, 
but there is no regulatory authority over their use.
    The effect of adopting a limited number of attachments standards at 
first is to permit covered entities time to gain experience with new 
standards and to evaluate the technical and business impacts of such 
transactions. In the meantime, while the electronic attachment 
specifications for DME, periodontal care, and home health are still 
under development, covered entities are strongly encouraged to actively 
participate in the development, review and modification process, and to 
advance their own proposals for these and other electronic attachments.
    Any new electronic attachment specifications, such as the ones 
referenced above, will be developed in accordance with the framework of 
the HL7 CDA Release 1.0. If CDA Release 2.0 is approved, the HL7 ASIG 
will determine if the next set of AISs will use CDA Release 2.0, or 
continue to be built on Release 1.0. HL7 will advise HHS as to the 
industry impact if the later version of CDA is adopted, particularly 
since covered entities need to be able to use both versions without 
requiring additional system changes. Industry representatives 
interested in participating in the development process should work in 
collaboration with HL7.
    In fact, as these and other new electronic attachments are 
developed, we strongly encourage the health care provider and health 
plan segments of the industry to review them and then provide 
substantial input on the ``questions'' or LOINC[supreg] codes, and on 
the cardinality (priority values) of the data elements--in other words, 
which elements should be required and which should be situational or 
optional for each electronic attachment type. Health care providers and 
health plans will recall their implementation experiences with the 
Transactions Rule and have an appreciation of the extreme importance of 
evaluating and understanding both the technical and business 
requirements of the standards and guides, and of submitting their 
issues and recommendations to the SDOs, DSMOs, and the regulators. We 
also solicit industry input on the impact to servers and other data 
storage systems for processing and storing electronic files of clinical 
information, both coded and text or image based.
6. Format Options (Human vs. Computer Variants) for Electronic Claims 
Attachments
    [If you choose to comment on issues in this section, please include 
the caption ``FORMAT OPTIONS'' at the beginning of your comments.]
    The Department and the standard setting organizations are sensitive 
to the fact that many health care providers, particularly smaller 
practices that are not yet fully automated, may be looking for means to 
convert from paper to electronic records in a cost effective, staged 
manner. To encourage such a transition, the standard setting 
organizations have proposed an approach to electronic health care 
claims attachments that could provide the benefits of electronic 
transmission of the information for both the health care provider and 
the health plan but that would not require a large upfront investment 
in electronic medical records systems, or the immediate merging of 
financial/administrative and clinical systems. Under this proposal, the 
electronic health care claims attachments may be sent in one of three 
formats, shown in the table below. Two of the formats are in the 
category of Human Decision Variant, and the third format is a Computer 
Decision Variant. There is a lengthy discussion of these variants along 
with examples later in this preamble, based on a white paper written by 
members of HL7's Attachments Special Interest Group.
    Human Decision Variants: (1) Many health care providers may choose 
to send scanned or imaged documents in the X12 transaction, and health 
plans will use manual procedures to process them; a health plan 
employee will physically look at the contents of the attachment to 
adjudicate the claim. Simply put, the health care provider would send a 
virtual document inside the X12 transaction and the health plan would 
view it on the computer screen, or a printed hard copy. This process is 
one of the human decision-making variants because it allows for the 
transmission of scanned page images. After the image has been rendered 
(printed or viewed as a document), the information should be clear 
enough and contain sufficient data for a person--the health plan's 
employee--to make a decision about the claim. (2) The second type of 
human decision variant is even simpler: The health care provider 
responds to the electronic request using narrative text, such as a 
typed response to the question, again embedding this response into the 
BIN segment of the X12 transaction. The health plan employee reads the 
answer off the screen, or prints a hard copy for review.
    Computer Decision Variant: The computer decision variant contains 
additional information that is structured so that it can be 
electronically extracted for use in computer-based adjudication 
systems, using automated processing rules. The codes will literally be 
read and interpreted by the computer. Auto-adjudication is the use of 
computers, programmed with business rules and logic, to process a 
claim, making decisions as to whether to pay, how much to pay, and to 
whom to make the payment. It is a long-term goal for most health plans 
to be able to support auto-adjudication for as many claims as possible.
    Even with this variant, HL7 will supply ``stylesheets'' that will 
put any data into an HTML or screen readable format. This means that 
health plans

[[Page 55998]]

that do not intend to auto-adjudicate in the short term, may continue 
to use low-cost technology to print or display the electronic 
attachment information, regardless of which option or variant the 
health care provider uses.
    The human and computer variants do not differ in actual content. 
Both types of variants (human and computer) for each electronic 
attachment type have required and optional content elements, which are 
listed in the specification for that attachment. Both types of variants 
will satisfy the standard, as they will differ only with regard to 
whether or not structured and coded data are required. That is, in the 
computer variant, coded data are required, whereas in the human 
variants, coded data are not required. While both variant types will 
carry a LOINC[supreg] code or codes, they will be accompanied by the 
natural text translation (narrative text) in the same transaction, so 
the request will be understandable in either the human or the computer 
variant.

    Table 1.--Human vs. Computer Variants for Electronic Attachments
------------------------------------------------------------------------
                                   Information       Information sent as
           Variant               representation             * * *
------------------------------------------------------------------------
Human Decision..............  Scanned image.......  Scanned image of
                                                     pages from the
                                                     medical record.
                                                     Repeats
                                                     LOINC[supreg] code
                                                     from the request.
Human Decision..............  Natural language      Natural language
                               text.                 text with captions
                                                     that match the
                                                     specified
                                                     questions. Repeats
                                                     LOINC[supreg] code
                                                     from the request.
Computer Decision...........  Natural language      Natural language
                               text and structured   text, captions
                               information.          identified by
                                                     LOINC[supreg] codes
                                                     and supplemented by
                                                     coded information.
------------------------------------------------------------------------
Source: Gartner Research 2003.

7. Combined Use of Two Different Standards Through Standard Development 
Organization (SDO) Collaboration
    [If you choose to comment on issues in this section, please include 
the caption ``COMBINED USE OF DIFFERENT STANDARDS'' at the beginning of 
your comments.]
    As discussed in the previous section, claims attachment 
transactions contain both administrative and clinical information. 
Thus, attachment data could come from a health care provider's clinical 
record system, whether paper or electronic, as well as from its 
practice management or billing system. Historically, these two distinct 
areas (clinical vs. administrative) have been the domain of two 
different SDOs: HL7 focuses on clinical data standards, while X12 
concentrates on administrative data and transactions. In 1997, a joint 
effort between HL7 and X12 produced several options that would 
facilitate the communication of both clinical and administrative data, 
as well as smooth the transition from paper to a standardized 
electronic process for health care claims attachment information.
    ASC X12N, through its Patient Information Standards Work Group 
(WG9), developed transactions and the accompanying X12 implementation 
guides to fulfill the administrative needs of an electronic attachment 
request and the response to that request. HL7, through its ASIG, 
developed the message structure and the additional information 
specifications employing LOINC[supreg] codes that were relevant to the 
major types of clinical data needed in claims attachments. The ASIG 
included HL7 representatives, members of X12's WG9, and several vendors 
and health care providers with HL7 experience. The purpose of proposing 
the combined use of both ASC X12N and HL7 standards is to address both 
the administrative and clinical aspects of the attachment transactions 
from a format and content perspective. However, because these two 
standards have not been used together before, we solicit industry 
feedback regarding this strategy.
    One of the benefits of standardizing health care claims attachments 
is that it allows health care providers to anticipate requirements from 
health plans regarding additional documentation for claims 
adjudication. This should present opportunities for providers to 
develop procedures and systems to collect the data specified in the X12 
Implementation Guides and HL7 Additional Information Specifications. 
Health care providers would also be given considerable latitude on how 
to submit the information--with either narrative text, scanned 
documents or with fully coded data, permitting the use of some form of 
electronic attachments for health care providers that do not have 
computer-based medical record systems.
    From the health plan perspective, the requirements for use of the 
two standards can be met with a low impact implementation for claims 
adjudication, based on a person looking at the content of the 
electronic attachment in a text/readable format, regardless of how it 
is submitted. While the proposed process supports auto-adjudication, it 
does not require it for compliance.

D. Electronic Health Care Claims Attachment Business Use

    A health care claims attachment conveys supplemental information 
pertaining to the services provided to a specific individual to support 
evaluation of a claim before it is paid. An attachment might contain 
biometric data; medical history; clinical data (reports, studies, 
notes); hospital discharge notes; laboratory