[Federal Register: February 25, 2005 (Volume 70, Number 37)]
[Notices]
[Page 9355-9358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe05-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3119-FN]
RIN 0938-AM36
Medicare Program; Procedures for Maintaining Code Lists in the
Negotiated National Coverage Determinations for Clinical Diagnostic
Laboratory Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
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SUMMARY: This notice finalizes the procedures proposed in the Federal
Register on December 24, 2003 (68 FR 74607). It establishes the
procedures for maintaining the lists of codes that were included in the
national coverage determinations (NCDs) that were announced in an
addendum to the final rule published in the Federal Register on
November 23, 2001 (66 FR 58788). The final notice also sets forth the
circumstances in which a laboratory is permitted to use the date a
specimen was retrieved from storage for testing as the date of service
instead of the date of collection.
DATES: Effective Date: The notice is effective on March 28, 2005.
FOR FURTHER INFORMATION CONTACT: Jackie Sheridan-Moore, (410) 786-4635.
SUPPLEMENTARY INFORMATION:
I. Background
A. Current Statutory Authority and Medicare Policies
Sections 1833 and 1861 of the Social Security Act (the Act) provide
for payment of, among other things, clinical diagnostic laboratory
services under Medicare Part B. A laboratory furnishing tests on human
specimens must meet all applicable requirements of the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578)
enacted on October 31, 1988, as implemented by the regulations set
forth at 42 CFR part 493. Part 493 applies to all laboratories seeking
payment under the Medicare and Medicaid programs.
Under section 1842(a) of the Act, we contract with carriers to
perform bill processing and benefit payment functions for Medicare Part
B (Supplementary Medical Insurance). Under section 1816(a) of the Act,
we contract with fiscal intermediaries to perform claims processing and
benefit payment functions for Medicare Part A (Hospital Insurance).
Fiscal intermediaries also process claims payable from the Medicare
Part B trust fund that are submitted by providers that participate in
Medicare Part A, like hospitals and skilled nursing facilities. We use
the term ``contractor(s)'' to mean carriers and fiscal intermediaries.
Medicare contractors review and adjudicate claims for services to
ensure that Medicare payments are made only for services that are
covered under Medicare Part A or Part B. If a contractor develops a
local coverage determination (LCD) (formerly called local medical
review policies (LMRP)), its LCD/LMRP applies only within the
geographic area it serves as stated in the September 26, 2003 notice
(68 FR 55636). Current guidance regarding the development of LCDs/LMRPs
appears in section 13.1.3 of the Program Integrity Manual (HCFA Pub.
100-8).
B. Legislation
Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA) (Pub.
L. 105-133) enacted on August 5, 1997, mandates the use of a negotiated
rulemaking committee to develop national coverage and administrative
policies for clinical diagnostic laboratory services payable under
Medicare Part B by January 1, 1999. Section 4554(b)(2) of the BBA
requires that these national coverage policies be designed to promote
program integrity and national uniformity and simplify administrative
requirements for clinical diagnostic laboratory services payable under
Medicare Part B.
As directed by this statutory provision, we convened a negotiated
rulemaking committee that developed recommendations for coverage and
administrative policies in accordance with the provisions of the BBA.
On March 10, 2000, we published a proposed rule in the Federal Register
(65 FR 13082) proposing to adopt the committee's recommendations. The
final rule was published on November 23, 2001 in the Federal Register
(66 FR 58788).
C. National Coverage Determinations (NCDs)
The final rule on coverage and administrative policies for clinical
diagnostic laboratory services includes an addendum containing NCDs for
23 clinical diagnostic laboratory tests. These NCDs are binding on all
Medicare carriers, intermediaries, quality improvement organizations,
health maintenance organizations, competitive medical plans, and health
care prepayment plans.
In accordance with the recommendations of the negotiated rulemaking
committee, we developed these clinical diagnostic laboratory NCDs in a
prescribed format. Each NCD has the following sections: the official
title of the NCD, other names or abbreviations, description, Healthcare
Common Procedure Coding System (HCPCS) codes, indications, limitations,
International Classification of Diseases, Ninth Edition, Clinical
Modification (ICD-9-CM) codes covered by the Medicare program, reasons
for denial, ICD-9-CM codes denied, ICD-9-CM codes that do not support
medical necessity, sources of information, coding guidelines,
documentation requirements, and other comments.
For each of the clinical diagnostic laboratory service NCDs
(laboratory NCDs), every ICD-9-CM diagnosis code falls into one of the
three code lists. The list of covered codes is intended to reflect the
coding translation of the conditions enumerated in the narrative
indications section of the NCDs.
On April 27, 1999, we published a notice (64 FR 22619) outlining
our procedures for developing and revisiting NCDs. We further updated
the NCD process in a notice published in the Federal Register on
September 26, 2003 (68 FR 55634). In the November 23, 2001 final rule
(66 FR 58793) for coverage and administrative policies for clinical
diagnostic laboratory services, we stated that we will use the NCD
process for making changes to the laboratory NCDs. At the conclusion of
the NCD decision-making process, decision memoranda will be published
on the CMS Web site that announce the policy we intend to issue and
discuss the evidence we evaluated and our rationale for the final
national coverage
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determination. Coverage issues are announced at http://cms.hhs.gov/coverage
.
D. Updates of Coding Systems
1. ICD-9-CM Codes
International Classification of Diseases, Ninth Edition, Clinical
Modification (ICD-9-CM) codes were developed in 1977 as a means of
classifying morbidity data for indexing medical records, medical case
reviews, and ambulatory and other medical care programs, as well as for
basic health statistics. Since 1989, Sec. 424.32(a)(2) has required
the reporting of ICD-9-CM coding on all bills for physicians' services.
In September 1985, the ICD-9-CM Coordination and Maintenance
Committee (the Committee) was formed. This is a Federal
interdepartmental committee, co-chaired by CMS and the National Center
for Health Statistics (NCHS), and charged with maintaining and updating
the ICD-9-CM system. The Committee is jointly responsible for approving
coding changes, and developing errata, addenda, and other modifications
to the ICD-9-CM to reflect newly developed procedures and technologies
and newly identified diseases.
The Committee holds public meetings for discussion of educational
issues and proposed coding changes. These meetings provide an
opportunity for representatives of recognized organizations in the
coding field, such as the American Health Information Management
Association (AHIMA), the American Hospital Association (AHA), and
various physician specialty groups to contribute ideas on coding
matters. After considering the opinions expressed at the public
meetings and in writing, the Committee formulates recommendations that
must be approved by the agencies.
ICD-9-CM coding updates are issued annually but in accordance with
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA) may be issued semi-annually beginning on October 1, 2004.
Updated ICD-9-CM codes can be found at http://cms.hhs.gov/paymentsystems/icd9.
Minutes from the ICD-9-CM Committee meetings are
available on the Internet at http://cms.hhs.gov/paymentsystems/icd9. We
announce the annual ICD-9-CM procedure coding changes in the Federal
Register as part of the annual update of the hospital inpatient
prospective payment system (PPS). Section 503(a) of the MMA requires
updating of the ICD-9-CM codes in April of each year, but the addition
of these codes will not require adjustment to the payment systems until
the following fiscal year. Consequently, if we update codes for April,
we will do so through our issuance system and follow it up with a
notice in the subsequent PPS Final Rule in the Federal Register. These
codes are not accompanied with payment adjustments. In addition,
information on the diagnosis coding changes is available on the
Internet at http://www.cdc.gov/nchs/icd9.htm.
2. CPT-4 Coding
The Current Procedural Terminology (CPT), Fourth Edition, is a
listing of descriptive terms and identifying codes for reporting
medical services and procedures performed by physicians. The purpose of
the terminology is to provide consistent codes for medical, surgical,
and diagnostic services.
The American Medical Association (AMA) convenes the CPT Editorial
Panel (the Panel) quarterly to consider requests and suggestions for
changes to CPT. The Panel uses the services of an Advisory Committee
with expertise in a wide variety of specialties. More information
regarding the CPT Editorial Panel is available on the following
Internet Web site: http://www.ama-assn.org/ama/pub/category/3884.html.
E. Implementation of NCDs
One of the goals of section 4554 of the BBA is to promote
uniformity in Medicare processing of claims for clinical diagnostic
laboratory services. We developed an electronic edit table module that
is installed in each of the Medicare claims processing contractors'
systems. The edit module ensures that: (1) Each contractor matches
diagnosis to procedures in the same manner; (2) competing laboratories
in an area will have their claims processed identically regardless of
whether they are processed by the carrier or fiscal intermediary; and
(3) all local contractors will have implemented the laboratory NCDs at
the same time. The edit module is updated quarterly as necessary to
accommodate coding changes and NCD modifications.
II. Provisions of the Proposed Notice
A. Proposed Process for Code Maintenance
In the preamble of the final rule published on November 23, 2001 in
the Federal Register (66 FR 58788), we announced that we intend to
conduct maintenance of the 23 laboratory NCDs and create new laboratory
NCDs through the NCD process described in the general notice in the
Federal Register on April 27, 1999 (64 FR 22619). This process has
since been updated by a notice published on September 26, 2003 (68 FR
55634). These notices describe an evidence-based method in which
determinations are made based on the scientific literature. Formal
requests for an NCD must be made in accordance with the provisions of
the September 26, 2003 notice (68 FR 55636). The NCD process is further
modified by the provisions of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA). We expect to issue a
guidance document incorporating the changes made to the NCD process by
section 731 of the MMA in the near future. A summary of the NCD process
is posted on the Internet at http://www.cms.hhs.gov/coverage/8a4.asp.
We believe that this NCD process is appropriate for creating new
NCDs for clinical diagnostic laboratory services. Likewise, the NCD
process is appropriate for requests for substantive changes to the
existing laboratory NCDs. However, we believe this process is unduly
burdensome and time-consuming for requests for other changes to the
existing laboratory NCD code lists.
We proposed to establish three separate processes for requesting
changes to the laboratory NCDs. In this final notice, we are finalizing
the procedures we proposed in the December 24, 2003 Federal Register
(68 FR 74607). Substantive changes would use the normal evidence-based
NCD process. Coding changes that flow from the existing NCD narratives
of covered indications would be requested by a letter detailing how the
covered indication(s) in the narrative support the proposed coding and
descriptor changes. Scientific evidence in support of these requests
would not be required but would be welcomed to support the requestor's
position. Typographical errors and new codes and descriptors would be
implemented through program instructions without public comments.
1. Codes that Flow From the Covered Indications Narrative
We proposed to establish an abbreviated process for handling
requests for certain NCD narrative based coding changes to the
laboratory NCDs. In order for change requests to qualify for this
process, the new coding must flow from the existing narrative
indications in a laboratory NCD. Requests that, in effect, constitute
requests to add new indications must continue to use the NCD evidence-
based process outlined in the September 26, 2003 Federal Register (68
FR 55636).
The abbreviated process is similar to the NCD process in that it
includes
[[Page 9357]]
posting on the Internet and an opportunity for the public to comment
before coding change(s) are made. The principal difference between the
processes is the volume of information required. Requesters using the
abbreviated process will submit a letter detailing the provision of the
NCD narrative that clearly indicates coverage for the requested code.
Scientific literature in support of the coding change is not required.
However, scientific literature supporting the request and clinical
guidelines from relevant healthcare organizations is welcome.
2. Clerical Coding Change
The ICD-9-CM diagnosis codes and the CPT procedure codes are
periodically updated with coding and descriptor changes. Codes and
descriptors that are changed through this process may include those
that have been incorporated in the laboratory NCDs. We believe the NCDs
must be updated quickly to reflect current coding practices whenever
the coding and descriptor changes occur. Similarly, clerical errors in
laboratory NCD code lists, like typographical errors, should be
corrected as quickly as possible. Consequently, we proposed to
establish a streamlined process for making clerical changes to codes
contained within the laboratory NCDs. (See the December 24, 2003
Federal Register notice (68 FR 74607)).
Under this proposal, the general public would request clerical or
ministerial changes by sending a letter to: Director, Coverage and
Analysis Group, Mail Stop C1-09-06, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850. In addition, we would initiate this process to
correct clerical and ministerial errors that we discover. We would
incorporate all of these changes into the edit module software and
announce them in the coding manual that we publish on the Internet at
http://www.cms.hhs.gov/ncd/labindexlist.asp.
In summary, we proposed to establish three separate processes for
maintaining the laboratory NCDs. We would make clerical and ministerial
changes quickly without prior posting on the Internet or public
comment. We would announce clerical changes in a CMS instruction before
incorporation into the edit software. Coding changes that flow from the
narrative of the existing NCD would be handled through an abbreviated
process similar to the NCD process. Requests for coding changes that
flow from the existing narrative NCD would not require the submission
of scientific evidence. We would post a notice of this type of request
on the Internet and accept public comments for 30 days before making a
determination. Requests for a substantive change to an NCD would
continue to be handled through the normal NCD process described in the
September 26, 2003 Federal Register (68 FR 55634). Requests for
substantive changes to NCDs would continue to require scientific
evidence in support of the change in policy. We would post a tracking
sheet announcing our acceptance of a request to substantively change an
NCD on the Internet and public comments would be solicited for 30 days
before making a determination. The draft decision memorandum for NCDs
would be open to pubic comment before implementation.
B. Publication of the Code Lists for the Laboratory NCDs
We have generally published NCDs in the Medicare Coverage Issues
Manual (CIM). This manual was replaced by the National Coverage
Determination (NCD) Manual.
We proposed to incorporate only the narrative portion of the
laboratory NCDs in the NCD Manual. The coding lists and standardized
portions of the NCDs would be displayed in a laboratory NCD Coding
Manual that is available electronically on the Internet at http://www.cms.hhs.gov/ncd/labindexlist.asp.
Printed copies would be made
available to readers who do not have access to the Internet for a fee
of 10 cents per page.
C. Date of Service
In the final rule of coverage and administrative policies for
clinical diagnostic laboratory services that we published on November
23, 2001 (66 FR 58792), we clarified the date of service for clinical
diagnostic laboratory services. Specifically, we stated that: ``For
laboratory tests that require a specimen from stored collections, the
date of service should be defined as the date the specimen was obtained
from the archives.''
The final rule did not further define how long a specimen must be
stored before it is considered ``archived.'' We clarified in Program
Memorandum AB-02-134, that in the absence of specific instructions
issued nationally through rulemaking, contractors have discretion in
making determinations regarding the length of time a specimen must be
stored to be considered ``archived.'' We stated, however, that the rule
contemplates a long storage period.
We proposed to further clarify the date of service provision for
clinical diagnostic laboratory services. We suggested requiring that a
specimen must be stored for more than 30 calendar days to be considered
``archived.'' The date of service for these archived specimens would be
the date the specimen was obtained from storage. Specimens stored 30
days or less would have a date of service of the date the specimen was
collected.
The final rule also clarified that the date of service for tests
when the collection spanned more than 24 hours would be the date the
collection began. These extended collection periods are common on fecal
occult blood tests and urine collections for hormone analysis in
pregnant women.
We have received several comments since issuing the final rule that
stated that the common practice in the laboratory community is to use
the date the collection ended as the date of service. We proposed to
alter our policy to specify that the date of service would be the date
the collection ended instead of the date the collection began.
III. Analysis of and Responses to Public Comments
We received no public comments on the December 24, 2003 proposed
notice (68 FR 74607).
IV. Provisions of the Final Notice
We are establishing the provisions of the proposed notice as final.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether OMB should approve an information
collection, section 3506(c)(2)(A) of the 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.
In summary, we are establishing a new process for handling requests
for certain coding changes to the laboratory NCDs. In order for
requests to qualify for this process, requests must be made in writing
to us, clearly stating the rationale for the coding change. The request
must articulate that the codes
[[Page 9358]]
flow from the existing narrative indications for the clinical
diagnostic laboratory test. In other words, the requested change must
be classified as a correction, an updating change, or a replacement to
an existing code. Requests that, in effect, constitute requests to add
new indications must use the NCD evidence-based process outlined in the
April 27, 1999 and subsequent September 26, 2003 issues of the Federal
Register.
The burden associated with the process referenced above is the time
and effort necessary to submit a request in writing, clearly stating
the rationale for the coding change. We believe that it will require
one hour per request and that eight requests will be submitted on an
annual basis.
However, based on the current number of submissions received on an
annual basis (less then 10), this is not an information collection
defined by the PRA (5 CFR 1320.3(c)(4)). If in the future we receive
more than 10 responses on an annual basis, we will submit these
information collection requirements to OMB for review and approval as
required by the PRA.
VI. Regulatory Impact Statement
In this notice, we establish an abbreviated mechanism for making
changes to the lists of ICD-9-CM and CPT codes that are included in the
laboratory NCDs. We clarify when a specimen is considered archived for
purposes of the date of service provision contained in the November 21,
2001 final rule. We do not expect this rule to impose any significant
burden on laboratories. The established policy clarifications may
lessen the burden on laboratories by establishing uniform procedures
for reporting date of service on archived specimens. Should there be
any unanticipated increase or decrease of burden, the effects will be
minimal.
We have examined the impacts of this final notice 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), section 1102(b) of the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) 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 in any 1 year).
We have reviewed this final notice and have determined it is not a
major rule. Therefore, we are not required to perform an assessment of
the costs and savings. The notice is purely procedural and, therefore,
is not expected to impose any appreciable burden or generate compliance
costs for laboratories.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals, and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. For purposes of the RFA,
approximately 80 percent of clinical diagnostic laboratories are
considered small businesses according to the Small Business
Administration's size standards with total revenues of $29 million or
less in any 1 year. Individuals and States are not included in the
definition of a small entity. We are not preparing an analysis for the
RFA because we have determined that this final notice will not have a
significant 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 604 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 a Metropolitan
Statistical Area and has fewer than 100 beds. We are not preparing an
analysis for section 1102(b) of the Act because we have determined that
this final notice will not have a significant impact on the operations
of 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 notice that may result in expenditure in any 1 year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. This final notice will have no
consequential effect on the governments mentioned or on the private
sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final notice that imposes
substantial direct requirement costs on State and local governments,
preempts State law, or otherwise has Federalism implications. We have
reviewed this final notice and have determined that it will not have a
substantial effect on State or local governments.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
Dated: September 1, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: November 9, 2004.
Tommy G. Thompson,
Secretary.
[FR Doc. 05-3727 Filed 2-24-05; 8:45 am]
BILLING CODE 4120-01-P