[Federal Register Volume 67, Number 105 (Friday, May 31, 2002)]
[Proposed Rules]
[Pages 38050-38056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-13615]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 162
[CMS-0005-P]
RIN 0938-AK76
Health Insurance Reform: Modifications to Transactions and Code
Set Standards for Electronic Transactions
AGENCY: Office of the Secretary, HHS.
ACTION: Proposed rule.
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SUMMARY: This rule proposes to adopt modifications to certain standards
adopted in our regulations entitled ``Health Insurance Reform:
Standards for Electronic Transactions'' published in the Federal
Register on August 17, 2000 (65 FR 50312), which
[[Page 38051]]
implemented some of the requirements of the Administrative
Simplification subtitle of the Health Insurance Portability and
Accountability Act of 1996. The proposed modifications are a result of
the Designated Standard Maintenance Organization (DSMO) process to
maintain standards adopted by the Secretary and to process requests for
adopting new standards or modifying adopted standards.
DATES: We will consider comments if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on July 1, 2002.
ADDRESSES: In commenting, please refer to file code CMS-0005-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. Mail written comments (one original and
three copies) to the following address ONLY: Centers for Medicare and
Medicaid Services, Department of Health and Human Services, Attention:
CMS-0005-P, P.O. Box 8010, Baltimore, MD 21244-8010.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery delays. If you prefer, you may
deliver (by hand or courier) your written comments (one original and
three copies) to one of the following addresses: Room 445-G, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201,
or Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and could be considered late.
Comments may also be submitted electronically to the following e-
mail address: CMS0005@cms.hhs.gov. For e-mail procedures, see the
beginning of the SUPPLEMENTARY INFORMATION section.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Stanley Nachimson, (410) 786-6153.
SUPPLEMENTARY INFORMATION:
Public Comments: Normally, we provide a 60-day public comment
period for a proposed rule; for this rule, however, there is a 30-day
comment period. After publication of the Standards for Electronic
Transactions final rule (65 FR 50312), we received an overwhelming
response from the affected industry and industry representatives
requesting that we modify the standards. The changes we are proposing
already were subjected to the public DSMO process and were discussed
and approved by the National Committee on Vital and Health Statistics
(NCVHS) in public sessions. Therefore, we believe it is unnecessary to
provide more than a 30-day comment period for this rule.
Inspection of Public Comments: 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, Monday through Friday of
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view
public comments, please call (410) 786-9994.
Electronic Comments: We will consider all electronic comments that
include the full name, postal address, and affiliation (if applicable)
of the sender and are submitted to the electronic address identified in
the ADDRESSES section of this preamble. All comments must be
incorporated in the e-mail message because we may not be able to access
attachments. Electronically submitted comments will be available for
public inspection at 7500 Security Boulevard, Baltimore, MD 21244.
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Register online database through GPO Access, a service of the U.S.
Government Printing Office. The web site address is: http://
www.access.gpo.gov/nara/index.html.
I. Background
A. Legislation
The Congress included provisions to address the need for standards
for electronic transactions and other administrative simplification
issues in the Health Insurance Portability and Accountability Act of
1996 (HIPAA), Pub. L. 104-191, which became effective on August 21,
1996. Through subtitle F of title II of that statute, the Congress
added to title XI of the Social Security Act (the Act) a new Part C,
titled Administrative Simplification. Pub. L. 104-191 affects several
titles in the United States Code. The purpose of this part is to
improve the Medicare and Medicaid programs in particular and the
efficiency and effectiveness of the health care system in general by
encouraging the development of a health information system through the
establishment of standards and requirements to facilitate the
electronic transmission of certain health information.
Part C of title XI consists of sections 1171 through 1179 of the
Act. These sections define various terms and impose several
requirements on the Secretary, health plans, health care
clearinghouses, and certain health care providers.
We discussed the legislation in greater detail in the Standards for
Electronic Transactions final rule (Transactions Rule) published on
August 17, 2000 (65 FR 50312), and in a final rule for Privacy of
Individually Identifiable Health Information (Privacy Rule) published
on December 28, 2000 (65 FR 82462). Rather than repeating the
discussion here, we refer the reader to those documents for further
information about electronic data interchange and the statutory
background.
Section 1172 of the Act makes any standard adopted under part C
applicable to (1) health plans, (2) health care clearinghouses, and (3)
health care providers who transmit any health information in electronic
form in connection with a transaction covered by 45 CFR part 162.
In general, section 1172 of the Act requires any standard adopted
by the Secretary under this part to be a standard that has been
developed, adopted, or modified by a standard setting organization
(SSO). The Secretary may adopt a different standard if the standard
will substantially reduce administrative costs to providers and health
plans compared to the alternatives, and the standard is promulgated in
accordance with the rulemaking procedures of subchapter III of chapter
5 of Title 5, United States Code.
Section 1172 of the Act also sets forth consultation requirements
that must be met before standards are adopted by the Secretary. In the
case of a standard that is developed, adopted, or modified by an SSO,
the SSO must consult with the following Data Content Committees (DCCs)
in the course of the development, adoption, or modification
[[Page 38052]]
of the standard: the National Uniform Billing Committee (NUBC), the
National Uniform Claim Committee (NUCC), the Workgroup for Electronic
Data Interchange (WEDI), and the American Dental Association. In the
case of any other standard, the Secretary is required to consult with
each of the above-named groups before adopting the standard and must
also comply with the provisions of section 1172(f) of the Act regarding
consultation with the National Committee on Vital and Health Statistics
(NCVHS).
B. The Transactions Rule
The SSOs have developed a broad range of implementation
instructions for implementing standards for particular industry
sectors, for example, instructions on how to use the ASC X12N 837 to
claim payment for hospital services. The implementation instructions
for implementing standards are detailed and highly specific. Section
1172(d) of the Act requires the Secretary to establish specifications
for implementing each of the adopted standards, which were adopted in
the Transactions Rule. However, because the implementation instructions
are voluminous, they were incorporated by reference in the Transactions
Rule. This approach, to incorporate by reference, commonly is used by
the Office of the Federal Register when external standards developed by
SSOs are adopted as national standards. The approach allows the agency
to avoid publication of extraordinarily voluminous documents.
C. Designated Standard Maintenance Organizations
The Transactions Rule acknowledged the need for a group of
organizations to maintain the standards for health care transaction
standards adopted by the Secretary, and to receive and process requests
for adopting new standards or modifying adopted standards. ``Designated
Standard Maintenance Organization'' (DSMO) is the term used in the
Transactions Rule to identify the organizations designated by the
Secretary to undertake those functions. Section 162.910 of the
Transactions Rule sets forth the conditions under which an organization
may be designated a DSMO by the Secretary and the functions to be
performed by a DSMO. On August 17, 2000, the Secretary published a
Federal Register notice (65 FR 50373) designating the following six
organizations (three SSOs and three DCCs) as DSMOs. The organization
names are followed by their respective websites. All of the SSOs (X12,
NCPDP, and HL 7) that developed standards that the Secretary adopted or
expects to propose in the near future were designated as DSMOs:
Accredited Standards Committee X12 (ASC X12) (http://
www.x12.org).
Health Level Seven, Inc. (HL 7) (http://www.hl7.org).
National Council for Prescription Drug Programs (NCPDP)
(http://www.ncpdp.org).
National Uniform Billing Committee (NUBC) (http://
www.nubc.org).
National Uniform Claim Committee (NUCC) (http://
www.nucc.org).
Dental Content Committee of the American Dental
Association (http://www.ada.org).
The six organizations signed a Memorandum of Understanding (MOU)
agreeing to undertake the functions specified in Sec. 162.910 and to
follow a framework of cooperation with each other and HHS. The initial
term of the MOU is 3 years and is automatically renewed for subsequent
1-year periods. The MOU document sets forth a general process to be
followed by the DSMOs when a request is made to change the HIPAA
standards. The DSMOs designated a steering committee to facilitate
implementation of the MOU. In order to manage the change request
process, the signatory organizations agreed to:
Allow open public access
Provide for timely review
Cooperate and communicate
Consider all viewpoints
Evaluate the impact of each change request
Maintain a national perspective
Conform to law
A web site (http://www.hipaa-dsmo.org) was established for
requesting changes. For additional information regarding the general
change request management process, see the MOU document which is
available at: www.hipaa-dsmo.org/mou.pdf.
After the initial standards were adopted in the Transactions Rule,
a significant number of change requests were submitted through the DSMO
process. Many of those change requests were for changes that were
considered by the submitters to be essential to permit initial
implementation of the standards throughout the entire healthcare
industry. Those essential changes address specific details or elements
within the implementation specifications.
You can review all change requests reviewed by the DSMOs and sent
to NCVHS for adoption as addenda to the final rule at http://hipaa-
dsmo.org/crs/fasttrack.pdf. (Nonessential changes are still addressed
by the general change request management process set forth in the MOU.)
The procedure for electronically submitting change requests to the
DSMOs and specific details on submitted requests such as business needs
and disposition are available at the DSMO change request web site:
http://www.hipaa-dsmo.org.
The DSMOs as a group presented their list of proposed modifications
that they judged essential for implementation to the NCVHS. The NCVHS
held public hearings on those proposed changes (transcripts of those
hearings are available at http://www.ncvhs.hhs.gov). The NCVHS made its
own determination about the modification requests and recommended that
the Secretary adopt all of the changes proposed by the DSMOs as
modifications to the national standards.
II. Provisions of the Proposed Regulations
The Secretary reviewed the changes recommended by the NCVHS and is
proposing their adoption in this rule.
A. Summary
This rule proposes to make some limited technical modifications to
some of the transactions standards, specifically the implementation
specifications, adopted in the Transactions Rule by adopting those
changes identified by the DSMOs, and approved by the NCVHS, as
necessary to permit initial implementation of the standards within the
industry. Details of the proposed modifications are not set forth
specifically in this document, but are available at http://hipaa-
dsmo.org/crs/fasttrack.pdf. A summary of those details follows:
A total of 231 change requests were submitted to the DSMOs for
consideration. 85 requests were rejected because the implementation
specifications already met the specified business need, or the business
need was not well substantiated. 21 requests were recommended for
future changes. 6 requests were withdrawn by the submitter. 7 requests
were referred to the Department as policy issues. The remaining 115
change requests were approved and are included in the draft addenda.
They fell into 2 categories--48 maintenance changes (minor error
corrections, clarifications) and 67 modifications to the standards.
Details of these 67 modifications include:
Changing required data elements to situational (about 20 %
of changes) Submitters pointed out several data elements that were
required by the original standards, but were really only needed in some
situations. These data
[[Page 38053]]
elements were made situational in the addenda, with clearly defined
situations. Examples are:
1. Provider Taxonomy codes on claims-many health plans store this
information on their systems when providers enroll, so there is no need
to continually send this information. The code will now only be
reported ``when adjudication is known to be impacted by the code.''
2. Date last seen by physician (used for certain physical therapy
claims)--this is only needed by Medicare, so usage was changed from
required on all claims to ``required on Medicare claims.''
Removal of certain data elements (about 20% of changes)
Several data elements were removed since they do not appear to be
needed.
Examples are:
1. Referral date
2. Estimated date of birth
Allowing certain items to be reported via external code
sets rather than data elements in the transaction (about 20% of
changes)
There were several instances where codes could be used to indicate
certain data elements. This will allow external code set organizations
to easily update codes and reporting, as opposed to having the DSMOs
make changes to the standards.
Examples are:
1. Special program indicator codes
2. Newborn birth weights
Adding additional functionality to some transactions
(about 40% of changes) Requestors suggested several additional data
elements, codes, or loops to enable them to do certain business
functions in the transactions. These include:
1. Cross-referencing two subscriber IDs (surviving spouse and
dependents)
2. Sending a patient's primary care physician number
The DSMOs and the NCVHS determined that these proposed modifications
would respond to industry requests for changes that would facilitate
HIPAA implementation.
The SSOs have incorporated the proposed modifications for each
transaction into draft addenda for each implementation specification.
These draft addenda represent the final product of the DSMO change
request process, in that the requested change successfully completed
the DSMO change request process in the form of proposed draft addenda
to the adopted implementation specifications. As previously discussed,
the original implementation specifications are incorporated by
reference. This rule proposes to adopt the modifications in the draft
addenda. The addenda would be incorporated by reference just as are the
original implementation specifications. We are are soliciting comments
specifically on those modifications found in the draft addenda.
Comments may be submitted for specific individual proposed
modifications or for the proposed modifications collectively. The full
text of the draft addenda can be obtained from the Washington
Publishing Company, PMB 161, 5284 Randolph Road, Rockville, Md., 20852-
2116; telephone 301-949-9740. They are also available through the
Washington Publishing Company on the Internet at http://hipaa.wpc-
edi.com/HIPAAAddenda_40.asp.
B. Proposed Modifications
The Transactions Rule established standards for eight electronic
transactions, including, when appropriate, specific standards tailored
to specific industry sectors, for example, retail pharmacy,
institutional, and professional. The modifications proposed here would
affect some of the transaction standards (identified below). The new
standards would consist of the implementation guide plus the addenda.
The addenda are identified below:
1. Health care claims or equivalent encounter information
(Sec. 162.1102).
a. Dental Health Care Claims. The ASC X12N Addenda to Health Care
Claim: Dental, Version 4010, May 2000, Washington Publishing Company,
004010X097A1 (NPRM Draft Addenda October 2001).
b. Professional Health Care Claims. The ASC X12N Addenda to Health
Care Claim: Professional, Volumes 1 and 2, Version 4010, May 2000,
Washington Publishing Company, 004010X098A1 (NPRM Draft Addenda October
2001).
c. Institutional Health Care Claims. The ASC X12N Addenda to Health
Care Claim: Institutional, Volumes 1 and 2, Version 4010, May 2000,
Washington Publishing Company, 004010X096A1 (NPRM Draft Addenda October
2001).
2. Eligibility for a health plan (Sec. 162.1202).
Dental, professional, and institutional. The ASC X12N Addenda to
Health Care Eligibility Benefit Inquiry and Response, Version 4010, May
2000, Washington Publishing Company, 004010X092A1 (NPRM Draft Addenda
October 2001).
3. Referral certification and authorization (Sec. 162.1302).
The ASC X12N Addenda to Health Care Services Review-Request for
Review and Response, Version 4010, May 2000, Washington Publishing
Company, 004010X094A1 (NPRM Draft Addenda October 2001). In the
proposed rule titled CMS-0003-P, published elsewhere in this Federal
Register issue, we are proposing to add a new paragraph (a) to this
section.
4. Health care claim status (Sec. 162.1402).
The ASC X12N Addenda to Health Care Claim Status Request and
Response, Version 4010, May 2000, Washington Publishing Company
004010X093A1 (NPRM Draft Addenda October 2001).
5. Enrollment and disenrollment in a health plan (Sec. 162.1502).
The ASC X12N Addenda to Benefit Enrollment and Maintenance, Version
4010, May 2000, Washington Publishing Company 004010X095A1 (NPRM Draft
Addenda October 2001).
6. Health care payment and remittance advice (Sec. 162.1602).
a. Dental, professional, and institutional health care claims and
remittance advice. The ASC X12N Addenda to Health Care Claim Payment/
Advice, Version 4010, May 2000, Washington Publishing Company,
004010X091A1 (NPRM Draft Addenda October 2001).
C. Compliance Dates
The compliance date for the standards for the transactions adopted
in the Transactions Rule is October 16, 2002 for covered entities, with
the exception of small health plans, for which the compliance date is
October 16, 2003 (65 FR 50368). Under Sec. 160.104, the Secretary
establishes the compliance date for modifications. The date must not be
earlier than 180 days after the adoption date of the modification.
The Administrative Simplification Compliance Act (Pub. L. 107-105)
was enacted on December 27, 2001. This law provides an extension to the
compliance dates adopted in the Standards for Electronic Transactions
final rule of August 17, 2000 (65 FR 50368), for covered entities, with
the exception of small health plans, that submit a plan to the
Secretary of Health and Human Services indicating how the entity will
come into compliance by October 16, 2003. This plan must be submitted
to the Secretary before October 16, 2002. Entities that obtain such an
extension will also have a corresponding extension of the compliance
dates set forth in this proposed rule.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide a 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is
[[Page 38054]]
submitted to the Office of Management and Budget (OMB) for review and
approval. In order to fairly evaluate whether an information collection
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (PRA) requires that we solicit comment on the
following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
The collection of information requirements associated with the
transaction regulation are currently approved by OMB under OMB approval
number 0938-0866. We are soliciting public comments on each of the
above issues for the information collection requirements (ICRs)
contained in the sections covered by this proposed rule.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services,
Office of Information Services,
DCES, SSG,
Attn: John Burke,
Room N2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs,
Office of Management and Budget,
Room 10235, New Executive Office Building,
Washington, DC 20503,
Attn: Brenda Aguilar, CMS Desk Officer.
IV. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the major comments in the preamble to that
document.
IV. Regulatory Impact Analysis
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review) and the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, if regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety effects,
distributive impacts, and equity). A regulatory impact analysis (RIA)
must be prepared for major rules with economically significant effects
($100 million or more annually). An impact analysis was published in
the Standards for Electronic Transactions final rule of August 17, 2000
(65 FR 50350). This analysis detailed the significant costs and
benefits of adopting standard electronic transactions and codes sets.
The analysis assumed that the adopted standards would be able to be
implemented successfully by the industry. The changes in this proposed
rule are a result of industry analyses that showed certain minor
modifications in the adopted standards would be necessary to permit
industry compliance with the standards. These modifications would make
limited adjustments and corrections to the overall standards and would
facilitate the Congressional intent of implementation of national
electronic standards. Thus, the impact analysis previously published
would reflect industry experience if the changes proposed in this rule
are adopted.
In relation to the prior impact analysis, this rule would impose no
additional burdens and create no additional costs. All of the proposed
changes in this rule are required to facilitate successful
implementation of the standards. Their implementation would, in fact,
avoid costs that were not anticipated in the initial impact analysis.
Therefore, no additional impact analysis under Executive Order 12866 is
required.
It is estimated that substantial costs would incur for the health
care industry without the adoption of these proposed changes. The
proposed changes eliminate the need for expensive computer system
changes, and in some cases, facilitate an implementation that might not
have been possible without the proposed changes. The industry has
approved these proposed changes as an essential component to their
HIPAA implementation.
A total of 231 change requests were submitted to the DSMOs for
consideration. 85 requests were rejected because the implementation
specifications already met the specified business need, or the business
need was not well substantiated. 21 requests were recommended for
future changes. 6 requests were withdrawn by the submitter. 7 requests
were referred to the Department as policy issues. The remaining 115
change requests were approved and are included in the draft addenda.
They fell into 2 categories -48 maintenance changes (minor error
corrections, clarifications) and 67 modifications to the standards.
Details of these 67 modifications include:
Changing required data elements to situational (about 20%
of changes)
Submitters pointed out several data elements that were required by
the original standards, but were really only needed in some situations.
These data elements were made situational in the addenda, with clearly
defined situations. Examples are:
1. Provider Taxonomy codes on claims--many health plans store this
information on their systems when providers enroll, so there is no need
to continually send this information. The code will now only be
reported ``when adjudication is known to be impacted by the code.''
2. Date last seen by physician (used for certain physical therapy
claims)--this is only needed by Medicare, so usage was changed from
required on all claims to ``required on Medicare claims.''
Removal of certain data elements (about 20% of changes)
Several data elements were removed since they do not appear to be
needed.
Examples are:
1. Referral date.
2. Estimated date of birth.
Allowing certain items to be reported via external code
sets rather than data elements in the transaction (about 20% of
changes)
There were several instances where codes could be used to indicate
certain data elements. This will allow external code set organizations
to easily update codes and reporting, as opposed to having the DSMOs
make changes to the standards.
Examples are:
1. Special program indicator codes.
2. Newborn birth weights.
Adding additional functionality to some transactions
(about 40% of changes)
Requestors suggested several additional data elements, codes, or
loops to enable them to do certain business functions in the
transactions. These include:
1. Cross-referencing two subscriber IDs (surviving spouse and
dependents).
2. Sending a patient's primary care physician number.
These changes recognize that several pieces of information
initially required
[[Page 38055]]
by the standards were unduly burdensome to collect, so have been
changed to only be collected in a more limited set of circumstances.
One particular example is that of the provider information to be
collected for each service on a hospital claim. The initial standards
required that this information be collected if the provider is
different for each service (which it usually is in a hospital--
radiologists read x-rays, physical therapists provide therapy, etc.).
Many hospitals said that their systems do not routinely collect the
different providers for each claim, that this information is not
currently used by health plans for processing most claims, and it would
be extremely burdensome to collect such information.
As a result, the condition under which this information was
collected was revised in the implementation guide to state ``Required
when the line level information is known to impact adjudication''. This
will substantially reduce the number of claims for which this
information needs to be collected.
There are other examples of data elements that have been removed or
will be required under more limited circumstances.
The RFA requires agencies to determine whether a rule will have a
significant economic impact on a substantial number of small entities.
On November 17, 2000, the Small Business Administration (SBA) published
a final rule (65 FR 69432) changing the small business size standards
for the health care industry. This SBA final rule became effective
December 18, 2000. The size standards that the SBA now uses are those
defined by the North American Industry Classification System. Before
that, the SBA used size standards as defined by the Standard Industrial
Codes. The size standard is no longer a uniform $5 million in annual
revenues for all components in the health care sector. Rather, the size
standard now ranges from $6 million to $29 million. The regulatory
flexibility analysis for this proposed rule is linked to the aggregate
regulatory flexibility analysis for all the Administrative
Simplification standards that appeared in the final rule on Standards
for Electronic Transactions (65 FR 50312), published on August 17,
2000, which predated the SBA change. It is appropriate, for purposes of
this proposed rule, to continue to use the $5 million small business
size standard that was in effect at the time of publication of the
final rule on Standards for Electronic Transactions. Nonprofit
organizations are considered small entities. Small government
jurisdictions with a population of less than 50,000 are considered
small entities. Individuals and States are not considered small
entities. Most hospitals and most other providers and suppliers are
small entities, either by nonprofit status or by having revenues of $5
million or less annually. For purposes of the RFA, all retail
pharmacies are considered to be small entities. We have determined that
this proposed rule would not have a significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. We have determined that
this proposed rule would not have a significant impact on a substantial
number of small rural hospitals. Section 202 of the Unfunded Mandates
Reform Act of 1995 also requires that agencies assess anticipated costs
and benefits before issuing any rule that may result in an expenditure
in any 1 year by State, local, or tribal governments, in the aggregate,
or by the private sector, of $110 million. This rule would have no
mandated consequential effect on State, local, or tribal governments,
or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. We have determined that this proposed rule would not
significantly affect the rights, roles and responsibilities of States.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 45 CFR Part 162
Administrative practice and procedure, Electronic transactions,
Health facilities, Health insurance, Hospitals, Incorporation by
reference, Medicare, Medicaid, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Department of Health
and Human Services would amend 45 CFR subtitle A, subchapter C, part
162 as follows:
PART 162--ADMINISTRATIVE REQUIREMENTS
1. The authority citation for part 162 continues to read as
follows:
Authority: Secs. 1171 through 1179 of the Social Security Act
(42 U.S.C. 1320d--1320d-8), as added by sec. 262 of Pub. L. 104-191,
110 Stat. 2021-2031, and sec. 264 of Pub. L. 104-191, 110 Stat.
2033-2034 (42 U.S.C. 1320d-2 (note)).
2. Revise Sec. 162.1102 (b), (c) and (d) to read as follows:
Sec. 162.1102 Standards for health care claims or equivalent encounter
information.
* * * * *
(b) Dental Health Care Claims. The ASC X12N 837-Health Care Claim
Dental, Version 4010, May 2000, Washington Publishing Company,
004010X097 and Addenda to Health Care Claim Dental, Version 4010,
October 2001, Washington Publishing Company, 004010X097A1. The
implementation specification is available at addresses specified in
Sec. 162.920(a)(1).
(c) Professional Health Care Claims. The ASC X12N 837-Health Care
Claim: Professional, Volumes 1 and 2, version 4010, May 2000,
Washington Publishing Company, 004010X098 and Addenda to Health Care
Claim: Professional, Volumes 1 and 2, version 4010, October 2001,
Washington Publishing Company, 004010X098A1. The implementation
specification is available at the address specified in
Sec. 162.920(a)(1).
(d) Institutional Health Care Claims. The ASC X12N 837-Health Care
Claim: Institutional, Volumes 1 and 2, Version 4010, May 2000,
Washington Publishing Company, 004010X096 and Addenda to Health Care
Claim: Institutional, Volumes 1 and 2, Version 4010, October 2001,
Washington Publishing Company, 004010X096A1. The implementation
specification is available at the addresses specified in
Sec. 162.920(a)(1).
3. Revise Sec. 162.1202(b) to read as follows:
Sec. 162.1202 Standards for eligibility for a health plan.
* * * * *
(b) Dental, professional, and institutional. The ASC X12N 270/271-
Health Care Eligibility Benefit Inquiry and Response, Version 4010, May
2000, Washington Publishing Company, 004010X092 and Addenda to Health
Care Eligibility Benefit Inquiry and Response, Version 4010, October
2001, Washington Publishing Company, 004010X092A1. The implementation
specification is available at the addresses specified in
Sec. 162.920(a)(1).
* * * * *
[[Page 38056]]
4. Revise Sec. 162.1302 to read as follows:
Sec. 162.1302 Standard for referral certification and authorization.
The Secretary adopts the following standards for the referral
certification and authorization transaction:
(a) [Reserved]
(b) Dental, professional, and institutional referral certification
and authorization. The Secretary adopts the ASC X12N 278-Health Care
Services Review-Request for Review and Response, Version 4010, May
2000, Washington Publishing Company, 004010X094 and Addenda to Health
Care Services Review-Request for Review and Response, Version 4010,
October 2001, Washington Publishing Company, 004010X094A1 as the
standard for the referral certification and authorization transaction.
The implementation specification is available at the addresses
specified in Sec. 162.920(a)(1).
5. Revise Sec. 162.1402 to read as follows:
Sec. 162.1402 Standard for health care claims status.
The Secretary adopts the ASC X12N-276/277 Health Care Claim Status
Request and Response, Version 4010, May 2000, Washington Publishing
Company, 004010X093 and Addenda to Health Care Claim Status Request and
Response, Version 4010, October 2001, Washington Publishing Company,
004010X093A1 as the standard for the health care claim status
transaction. The implementation specification is available at the
addresses specified in Sec. 162.920(a)(1).
6. Revise Sec. 162.1502 to read as follows:
Sec. 162.1502 Standard for enrollment and disenrollment in a health
plan.
The Secretary adopts the ASC X12N 834-Benefit Enrollment and
Maintenance, Version 4010, May 2000, Washington Publishing Company,
004010X095 and Addenda to Benefit Enrollment and Maintenance, Version
4010, October 2001, Washington Publishing Company, 004010X095A1 as the
standard for enrollment and disenrollment in a health plan transaction.
The implementation specification is available at the addresses
specified in Sec. 162.920(a)(1).
7. Revise Sec. 162.1602(b) to read as follows:
Sec. 162.1602 Standards for health care payment and remittance advice.
* * * * *
(b) Dental, professional, and institutional health care claims and
remittance advice. The ASC X12N 835-Health Care Claim Payment/Advice,
Version 4010, May 2000, Washington Publishing Company, 004010X091 and
Addenda to Health Care Claim Payment/Advice, Version 4010, October
2001, Washington Publishing Company, 004010X091A1. The implementation
specification is available at the addresses specified in
Sec. 162.920(a)(1).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: March 20, 2002.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-13615 Filed 5-24-02; 4:53 pm]
BILLING CODE 4120-01-P