[Federal Register Volume 68, Number 247 (Wednesday, December 24, 2003)]
[Notices]
[Pages 74607-74613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3119-PN]
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: Notice of proposed procedures for code maintenance.

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SUMMARY: This proposed notice would establish the procedures for 
maintaining the lists of codes that were included in the national 
coverage determinations (NCDs) that were announced in the final rule 
published in the Federal Register on November 23, 2001 (66 FR 58788). 
It also sets forth the circumstances in which a laboratory is permitted 
to use the date the specimen was retrieved from storage for testing as 
the date of service instead of the date of collection. The proposed 
notice clarifies the meaning of the ``date of collection.'' In this 
proposed notice, we propose a standard time frame that would define 
when a specimen has been ``archived'' for undetermined later use.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on February 23, 2004.

ADDRESSES: In commenting, please refer to file code CMS-3119-PN. 
Because staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission or e-mail.
    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-3119-PN, P.O. 
Box 8011, Baltimore, MD 21244-8011. 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 two 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.
    (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 could be considered late.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

[[Page 74608]]


FOR FURTHER INFORMATION CONTACT: Jackie Sheridan-Moore, (410) 786-4635.

SUPPLEMENTARY INFORMATION:
    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, phone (410) 786-9994.

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. Diagnostic tests must be ordered either 
by a physician, as described in 42 CFR 410.32(a), or by a qualified 
nonphysician practitioner, as described in Sec.  410.32(a)(3). Tests 
may be furnished by any of the entities listed in Sec.  410.32(d). 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 non-exempt and non-excepted that test human specimens for 
the purpose of providing information for the diagnosis, prevention, or 
treatment of any disease or impairment of, or the assessment of the 
health of human beings. Section 1862(a)(1)(A) of the Act generally 
provides that no Medicare payment may be made for expenses incurred for 
items or services that are not reasonable and necessary for the 
diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member. Moreover, section 1862(a)(7) of 
the Act excludes coverage for routine physical checkup expenses, 
eyeglasses (other than eyewear described in section 1861(s)(8) of the 
Act), or eye examinations for the purpose of prescribing, fitting, or 
changing eyeglasses. In addition, the Act excludes coverage for 
procedures performed (during the course of any eye examination) to 
determine the refractive state of the eyes, hearing aids or 
examinations therefore, or immunizations (except as otherwise allowed 
under section 1861(s)(10) and subparagraphs (B), (F), (G), or (H) of 
paragraph (1)). Under the above statutory authority, we have issued 
national coverage determinations and policies in a variety of 
documents, such as CMS (formerly HCFA) manual instructions, Federal 
Register notices, and CMS (formerly HCFA) Rulings. Medicare program 
manuals, program transmittals, and program memoranda are posted on the 
Internet at http://cms.hhs.gov/manuals/default.asp.
    Under section 1842(a) of the Act, we contract with organizations to 
perform bill processing and benefit payment functions for Medicare Part 
B (Supplementary Medical Insurance). These Medicare contractors, who 
process Part B claims from noninstitutional entities, are called 
carriers. 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, such as 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. In the absence of a specific 
national coverage determination, coverage decisions are made at the 
discretion of the local contractors.

B. Recent Legislation

    Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Pub. 
L. 105-33, enacted on August 5, 1997, mandates 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 with respect to 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 (65 FR 13082) proposing 
to adopt the committee's recommendations. The final rule was published 
on November 23, 2001 (66 FR 58788).

C. National Coverage Determinations (NCDs)

    The final rule on coverage and administrative policies for clinical 
diagnostic laboratory services included an addendum containing NCDs for 
23 clinical diagnostic laboratory tests. These NCDs state our policy 
with respect to the circumstances under which the test(s) will be 
considered reasonable and necessary for Medicare purposes.
    NCDs are binding on all Medicare carriers, intermediaries, quality 
improvement organizations, health maintenance organizations, 
competitive medical plans, and health care prepayment plans (see 
section 1869(f)(1)(A)(i) of the Act).
    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/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. The translation of the narrative to 
the appropriate ICD-9-CM diagnosis codes ensures national uniformity in 
the processing of claims for these clinical diagnostic laboratory 
tests.
    On April 27, 1999, we published a general notice (64 FR 22619) 
outlining our procedures for developing and revisiting NCDs (the NCD 
process). 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 would use the NCD process for making changes to the 
laboratory NCDs. The NCD process is evidence-based and provides an 
opportunity for public

[[Page 74609]]

participation in the NCD decision-making process through the posting of 
announcements of issues under review on the Internet on the CMS 
coverage home page and requests for comment. At the conclusion of the 
NCD decision-making process, decision memoranda are published on the 
CMS website that announce the policy we intend to issue and discuss the 
evidence we evaluated and our rationale for the final national coverage 
determination. Coverage issues are announced at http://cms.hhs.gov/coverage.
    Under the November 23, 2001 final rule (66 FR 58793), code lists 
can only be modified through the NCD process. However, subsequent 
experience with the code lists has indicated that processes for routine 
changes are necessary. For example, experience with the code lists has 
revealed that clerical errors occasionally occur despite rigorous 
review. In addition, the committees that maintain the laboratory and 
related code lists (ICD-9-CM and CPT-4) routinely issue changes that 
modify laboratory coding procedures. As a result, the code list for a 
laboratory NCD may not reflect the most current coding practices. For 
these reasons, HHS is pursuing new processes in this proposed notice to 
update code lists for clerical or routine changes.

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. It delineates the clinical picture of each 
patient, providing information beyond that needed for statistical 
groupings and analyses of healthcare trends. Early in its history, ICD-
9-CM coding was used almost exclusively in institutional settings, such 
as hospitals. However, since 1989, Sec.  424.32(a)(2) has required the 
reporting of ICD-9-CM coding on all bills for physicians' services. 
Thus, ICD-9-CM has come into nearly universal use as a means of 
reporting diagnoses for patients receiving healthcare 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 is also responsible for 
promoting the use of Federal and non-Federal educational programs and 
other communication techniques with a view toward standardizing coding 
applications and upgrading the quality of the classification system.
    The Committee encourages participation in the above process by 
health-related organizations. In this regard, 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, as well as physicians, medical records administrators, health 
information management professionals, and other members of the public, 
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. Changes become 
effective October 1 of each year. 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. 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.
    CPT descriptive terms and identifying codes currently serve a wide 
variety of important functions in the field of medical nomenclature.
    The American Medical Association (AMA) owns CPT. 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. 
Portions of CPT panel meetings are open to the public for the 
opportunity to make presentations and participate in open discussions. 
Decision-making sessions, however, are closed. 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. 
CPT coding changes are announced annually. Category I changes become 
effective on January 1 of each year.

E. Implementation of NCDs

    One of the goals of section 4554 of the BBA was to promote 
uniformity in Medicare processing of claims for clinical diagnostic 
laboratory services. In order to ensure consistent and uniform 
implementation of the laboratory NCDs throughout the country, we 
developed an electronic edit table module that will be installed in 
each of the Medicare claims processing contractors' systems. The edit 
module will ensure 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 have implemented the laboratory NCDs at the same time.
    Professional coders on the negotiated rulemaking committee assisted 
in the development of the laboratory NCDs. Also, we presented the 
proposed code list to the staff in the Department of Health and Human 
Services and the general public for review. Nevertheless, we have 
discovered clerical errors in the code lists. For example, several of 
the codes did not include the full range of digits. That is, a code 
that requires 5 digits may have had only 4 digits. We identify this 
problem by the term ``truncated codes.'' The issue of truncated codes 
is particularly problematic because our claims processing systems 
already include edit programs that will return claims to the biller 
when codes are incomplete. That is, if an entity bills the 4-digit code 
from the list instead of the 5-digit code, the claim will be returned 
to the laboratory. However, if the laboratory bills the appropriate 5-
digit code, the claim will not be paid, as the 5-digit code is not on 
the covered code list. Other errors include instances in which the code 
and the descriptor did not match.

[[Page 74610]]

II. Provisions of the Proposed Notice

A. Proposed Process for Code Maintenance

    In the preamble of the November 23, 2001, final rule (66 FR 58788), 
we announced that we intended 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 general 
notice published on September 26, 2003 (68 FR 55634). This is an 
evidence-based method in which determinations are made based on the 
scientific literature. Formal requests for an NCD must be made in the 
following manner:
    [sbull] The request must be in writing.
    [sbull] The request and supporting documentation must be submitted 
electronically unless there is good cause for only a hardcopy.
    [sbull] The requestor must identify the request as a ``formal 
request for a national coverage'' determination.
    [sbull] The requestor must state the Medicare benefit category.
    [sbull] The requestor must submit adequate supporting documentation 
including:

--A full and complete description of the item or service in question;
--A compilation of the medical and scientific information currently 
available that measures the medical benefits of the item or service;
--A specific detailed description of the proposed use of the item or 
service including the target Medicare population and the medical 
condition(s) for which it can be used;
--An explanation of the design, purpose, and method of using the item 
or equipment;
--A description of any clinical trials or studies currently under way, 
which might be relevant to a decision; and
--The status of current Food and Drug Administration (FDA) 
administrative proceedings concerning a drug or device or a service 
using a drug or device subject to regulation by the FDA.

    We continue to 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 correcting errors 
in coding and for incorporating new codes and coding changes that may 
be created by the ICD-9-CM Coordination and Maintenance Committee or 
the AMA Editorial Panel. Likewise, we believe that a streamlined 
process is appropriate for making coding changes that flow from the 
existing narrative. Since the narratives only describe covered 
conditions this abbreviated approach may be used in moving codes from 
the ``Does Not Support Medical Necessity'' list (which can be covered 
with documentation) to the ICD-9-CM codes covered by the Medicare list. 
``ICD-9-CM Not Covered by Medicare'' list cannot be altered through 
this abbreviated process. Thus, we are proposing two additional 
processes for making requests for coding changes in the laboratory 
NCDs.
    We are proposing, therefore, to have three separate processes for 
requesting changes to the laboratory NCDs. Substantive changes would 
use the normal evidence-based NCD process. Clerical changes to codes 
and descriptors would be requested, as set forth below, by a letter 
that outlines the coding change made subsequent to the publication of 
the NCD or coding error. Coding changes that flow from the narrative 
covered indications would be requested by letter detailing the covered 
indication from the narrative. Scientific evidence would not be 
required, but is welcomed to support the requestor's position.
1. Clerical Coding Change
    Coding changes are made annually to both the ICD-9-CM diagnosis 
codes and the CPT procedure codes that may be incorporated in the 
laboratory NCDs. Whenever coding changes to codes or descriptors that 
are included in the NCD are made, we believe the NCDs should be updated 
expeditiously to reflect current coding practices. Similarly, clerical 
errors, such as typographical errors, should be corrected as quickly as 
possible. Consequently, we are proposing a streamlined process for 
making clerical changes to codes contained within the laboratory NCDs. 
We propose the following procedures:
    [sbull] Whenever we discover truncated codes (that is, ICD-9-CM 
codes that were not displayed to their highest level of specificity), 
we would expand the code to the full number of digits. We would use the 
expanded code that most closely matches the ICD-9-CM descriptor 
displayed in the NCD.
    [sbull] Whenever an ICD-9-CM or CPT code had been altered (that is, 
the descriptor was changed) by the responsible coding authority, we 
would make corresponding changes to the laboratory NCDs.
    [sbull] Whenever the responsible coding authority deletes an ICD-9-
CM or CPT code, we would remove the code from the NCD. We would not 
consider this as removal of coverage and would not first publish notice 
of removal of coverage before taking action.
    [sbull] Whenever the responsible coding authority changes or 
replaces an ICD-9-CM or CPT code, we would make corresponding changes 
to the laboratory NCD based on the crosswalk announced by the coding 
authority.
    [sbull] Whenever an ICD-9-CM or CPT code and its descriptor do not 
match (that is, the descriptor in the NCD is not the descriptor of the 
code in the coding manuals), we would look to the NCD narrative to 
determine which item (the code or descriptor) was correct and adjust 
the other item to match.
    [sbull] Whenever the responsible coding authority adds a new code 
to a range of covered codes, we would revise the NCD to include this 
code.
    We are proposing that the general public 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 may initiate changes 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#coding.
    We believe that the clerical nature of the changes makes public 
comments on these changes before implementation unnecessary. A method 
of recognizing necessary coding changes more rapidly would increase 
payment efficiency and accuracy. We believe that the urgent need to 
implement these clerical changes into the laboratory NCDs outweighs the 
benefit that could be derived from requesting public comment on these 
ministerial changes. Instead, we would accept comments that are 
generated from these clerical changes through the comment process 
described below.
2. Codes That Flow From the Covered Indications Narrative
    We have received several requests for a procedure to make changes 
to the codes in the various laboratory NCD code lists by a process 
other than the NCD process. Many laboratories believe that there have 
been omissions of codes from the code lists. However, they believe that 
the current process of gathering scientific evidence to support 
coverage of a specific code is unduly burdensome and unnecessary since 
the narrative already includes coverage of the substance of the code 
description. Therefore, we propose to establish an

[[Page 74611]]

abbreviated process for handling requests for certain coding changes to 
the laboratory NCDs. In order for requests to qualify for this process, 
the code must flow from the existing narrative indications for the 
clinical diagnostic laboratory test. In other words, the requested 
change must be classified as a replacement of or an addition to an 
existing code. Requests that in effect constitute requests to add new 
indications must use the NCD evidence-based process outlined in the 
September 26, 2003, Federal Register. Thus, any requests to cover codes 
that are in the list of ICD-9-CM Codes Not Covered by Medicare must use 
the NCD evidence-based process.
    The abbreviated process is similar to the NCD process in that it 
includes posting on the Internet and an opportunity for public comment 
before making a coding change. The principal difference between the 
processes is the volume of information required. Requesters using the 
abbreviated process would submit a letter detailing the provision of 
the NCD narrative that clearly indicates coverage for the requested 
code. Scientific literature is not required. However, scientific 
literature supporting the request and/or clinical guidelines from 
relevant healthcare organizations is welcome. We are proposing the 
following abbreviated process for coding changes that flow from the 
existing narrative of the NCD:
    [sbull] Requests must be made in writing, clearly stating the 
rationale for the coding change.
    [sbull] Requests must be sent to: Director, Coverage and Analysis 
Group, Centers for Medicare & Medicaid Services, C1-09-06, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.
    [sbull] Our staff will review the request and contact the requestor 
for additional information, if necessary.
    [sbull] We will announce on the Internet (http://cms.hhs.gov/coverage) any proposed coding changes. The announcement will provide 
for a 30-day public comment period.
    [sbull] Within 60 days of the end of the comment period, we would 
publish a decision memorandum on the coverage website including a 
summary of comments received, that announces the decision we intend to 
issue, and a brief explanation for the determination, if not self-
evident, in the request. Within 60 days after posting the decision 
memorandum, we would publish the decision as an instruction in a One 
Time Notification that includes the effective date of any changes. 
Codes that are removed from the covered list as a result of this 
process because they do not flow from the narrative would not be 
subject to additional prior notice of removal of coverage.
    [sbull] We would incorporate coding changes into the software and 
coding manual. Coding changes would be made effective on a quarterly 
basis.
    We would, whenever we become aware of the need to do so, also 
follow this process to implement the necessary changes. We specifically 
solicit comments on this streamlined process for making coding changes.
    In summary, we are proposing three separate processes for 
maintaining the laboratory NCDs. Clerical and ministerial changes would 
be made expeditiously without prior posting on the Internet or public 
comment. Clerical changes would be announced 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 
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 be 
handled through the normal NCD process described in the September 26, 
2003, Federal Register. The requests require scientific evidence in 
support of the change in policy. We will post a tracking sheet 
announcing our acceptance of a request on the Internet and public 
comments will be solicited for 30 days before making a determination.
3. Code Lists for the Laboratory NCDs
    We have generally published NCDs in the Medicare Coverage Issues 
Manual (CIM). This manual is being replaced by the National Coverage 
Determination (NCD) Manual. We have published some NCDs initially as a 
Program Memorandum but subsequently have moved the instruction to the 
CIM. However, we have not, up to this time, published NCDs that 
contained the detailed coding information that is contained in the 
clinical diagnostic laboratory service's NCDs that were negotiated.
    The clinical diagnostic laboratory NCDs include long lists of ICD-
9-CM codes, coding guidelines, and reasons for denial, resulting in a 
document of approximately 200 pages. Incorporation of this new style 
arising exclusively from the laboratory negotiated rulemaking process 
of NCD into the NCD Manual would dwarf the rest of the manual.
    We are proposing to incorporate in the NCD Manual only the 
narrative portion of the NCDs. That is, we would include in the NCD 
Manual the description of the service, indications, and limitations. We 
are proposing that the coding lists and standardized portions of the 
NCDs would be displayed in a laboratory NCD Coding Manual that would be 
available electronically on the Internet at http://www.cms.hhs.gov/ncd/labindexlist.asp#coding. Printed copies can be made available to 
readers who do not have access to the Internet for a fee of 10 cents 
per page.
    We believe this mechanism would make handling the NCD Manual easier 
for all users. Users could readily identify those conditions covered 
without having to weed through long documents with extensive lists of 
codes. In addition, we believe separating the coding information from 
the narrative policy helps to reinforce the differing procedures for 
substantively changing, as opposed to updating, coding in the NCDs.
    In summary, we are proposing a streamlined method of updating the 
NCDs for coding changes of a clerical nature, that is, correcting 
errors, and accommodating annual coding updates. We are also proposing 
to publish only the narrative portion of the laboratory NCDs in the NCD 
Manual, the document where NCDs are normally compiled. The entire 
laboratory NCDs, including the code lists and coding guidelines, would 
be published in an electronic laboratory NCD Coding Manual that would 
be available on the Internet, and upon request, in printed form for a 
fee. We request public comment on these proposals.

B. Date of Service

    In the final rule of coverage and administrative policies for 
clinical diagnostic laboratory services that we published on November 
23, 2001, we clarified the date of service for clinical diagnostic 
laboratory services (66 FR 58792). 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

[[Page 74612]]

stated, however, that the rule contemplates a long storage period.
    We have received numerous requests from laboratories to issue a 
national standard to clarify when a stored specimen can be considered 
``archived.'' Regional laboratories interact with numerous contractors 
and find it difficult to automate their electronic billing software to 
handle variability in date of service by contractor jurisdiction. In 
other words, it is difficult for laboratories to electronically program 
their systems to calculate the date of service when in one jurisdiction 
it would be the collection date while in another the date of service 
would be the day that the specimen was retrieved from storage.
    Consequently, we are proposing to further clarify the date of 
service provision for clinical diagnostic laboratory services. We 
propose 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. This clarification was added in the November 23, 2001, 
final rule in response to public comments received on the March 10, 
2000, proposed rule. Thus, we did not have the benefit of public input 
regarding the appropriateness of our solution.
    We have received several comments since issuing the final rule that 
stated the common practice in the laboratory community is to use the 
date the collection ended as the date of service. Thus, we are 
soliciting public comment on a proposal to alter our policy to specify 
that the date of service for collections that span more than 24 hours 
would be the date the collection ended.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, we are required to 
provide 60-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 an information collection should be 
approved by OMB, section 3506(2)(A) of the Paperwork Reduction Act of 
1995 requires that we solicit comments on the following issues:
    [sbull] The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    [sbull] The accuracy of our estimate of the information collection 
burden.
    [sbull] The quality, utility, and clarity of the information 
collection burden on the affected public, including automated 
collection techniques.
    In summary, we propose to establish 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 the code flow from the existing narrative 
indications for the clinical diagnostic laboratory test. In other 
words, the requested change must be classified as a correction, 
updating change, or 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, Federal Registers.
    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.
    In order to have this requirement approved under the PRA, we will 
amend the currently approved NCD/PRA documentation [OMB PRA approval 
 0938-0776] to include the new code updating process and 
resubmit it to OMB for approval. We believe that this abbreviated 
process is less burdensome than the current process. The current 
process requires submission of scientific evidence in order to initiate 
a change in the NCD. This abbreviated process requires only an 
explanation of how a code flows from the narrative.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following:

Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Regulations Development and 
Issuances Group, Attn: Julie Brown--CMS-3119-PN, Room C5-14-03, 7500 
Security Boulevard, Baltimore, Maryland 21244-1850.
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 notice, and, if we proceed with a subsequent document, 
we will respond to the comments in the final rule.

V. Regulatory Impact Statement

    In this notice, we propose an abbreviated mechanism for making 
changes to the lists of ICD-9-CM and CPT codes that are included in the 
laboratory NCDs. We also propose clarification of 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 
document to impose any significant burden on laboratories. The proposed 
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 proposed notice as required by 
Executive Order 12866 (September 1993, Regulatory Planning and Review) 
and the Regulatory Flexibility Act (RFA) (September 16, 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 alternative 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 proposed notice and have determined it is not a 
major rule. Therefore, we are not required to perform an assessment of 
the costs and savings.

[[Page 74613]]

    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. 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 proposed 
notice would 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 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 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 proposed notice would 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 rule 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 proposed notice would 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 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 reviewed this proposed notice and have determined 
that it would not have a substantial effect on State or local 
governments.
    In accordance with the provisions of Executive Order 12866, this 
document was reviewed by the Office of Management and Budget.

    Authority: Sections 1816(a), 1833, 1842(a), 1861, 1862(a)(1)(A), 
and 1862(a)(7) of the Social Security Act (42 U.S.C. 1395h(a), 
1395l, 1395u(a), 1395x, 1395y(a)(1)(A), and 1395y(a)(7))

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: May 23, 2003.
Thomas A Scully,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: September 16, 2003.
Tommy G. Thompson,
Secretary.
[FR Doc. 03-31573 Filed 12-23-03; 8:45 am]
BILLING CODE 4120-01-P