[Federal Register: November 23, 2001 (Volume 66, Number 226)]
[Rules and Regulations]               
[Page 58787-58836]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no01-8]                         
 

[[Page 58787]]

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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 410



Medicare Program; Negotiated Rulemaking: Coverage and Administrative 
Policies for Clinical Diagnostic Laboratory Services; Final Rule


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 410

[CMS-3250-F]
RIN 0938-AL03

 
Medicare Program; Negotiated Rulemaking: Coverage and 
Administrative Policies for Clinical Diagnostic Laboratory Services

AGENCY: Center for Medicare & Medicaid Services, (CMS) HHS.

ACTION: Final rule.

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SUMMARY: This final rule establishes national coverage and 
administrative policies for clinical diagnostic laboratory services 
payable under Medicare Part B to promote Medicare program integrity and 
national uniformity, and simplify administrative requirements for 
clinical diagnostic laboratory services. This rule addresses public 
comments received on the proposed rule that was published March 10, 
2000. A Negotiated Rulemaking Committee (the Committee) developed the 
policies as directed by section 4554(b)(1) of the Balanced Budget Act 
of 1997 (the BBA).

DATES: Effective November 25, 2002, except for sections 410.28(f), 
410.32(d) redesignations, (d)(1) heading, (d)(4) and (e), which are 
effective February 21, 2002. See the effective date section of the 
preamble for a discussion of the effective dates for provisions that 
were discussed in the preamble but not codified in the rule.

FOR FURTHER INFORMATION CONTACT: Jackie Sheridan, (410) 786-4635 (for 
issues related to coverage policies). Brigid Davison, (410) 786-8794 
(for issues related to documentation requirements). Dan Layne, (410) 
786-3320 (for issues related to claims processing).

SUPPLEMENTARY INFORMATION: The sections contained within this document 
have been constructed according to the framework outlined in the table 
of contents that follows. We summarized pertinent material from our 
proposed rule that was published on March 10, 2000 (65 FR 13082) 
followed by public comments and our responses.

Table of Contents

I. Background
    A. Current Statutory Authority and Medicare Policies
    B. Recent Legislation
II. Provisions of the March 10, 2000 Proposed Rule
III. Comments and Responses
IV. Summary of Changes Based on the March 10, 2000 Proposed Rule
V. Collection of Information Requirements
VI. Regulatory Impact Analysis

I. Background

A. Current Statutory Authority and Medicare Policies

    Section 1833 and 1861 of the Social Security Act (the Act) provides 
for payment of, among other things, clinical diagnostic laboratory 
services under Medicare Part B. Tests must be ordered either by a 
physician, as described in Sec. 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)(1). A 
laboratory furnishing tests on human specimens must meet all applicable 
requirements of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA) (Public Law 100-578), as set forth at 42 CFR part 493. Part 493 
applies to laboratories seeking payment under the Medicare and Medicaid 
programs.
    Section 1862(a)(1)(A) of the Act, to which there are certain 
explicit statutory exceptions, 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 ``where such 
expenses are for routine physical checkups, eye examinations for the 
purpose of prescribing, fitting, or changing eyeglasses, procedures 
performed (during the course of any eye examination) to determine the 
refractive state of the eyes, hearing aids or examination therefore, or 
immunizations (except as otherwise allowed under section 1861(s)(10) 
and paragraph (1)(B) or under paragraph (1)(F).
    Under the above statutory authority, we have issued national 
coverage decisions and policies in a variety of documents, such as 
Centers for Medicare & Medicaid Services manual instructions, Federal 
Register notices, and Centers for Medicare & Medicaid Services Rulings. 
We have issued approximately 20 national coverage decisions pertaining 
to clinical diagnostic laboratory services in the Medicare Coverage 
Issues Manual (CMS Pub. 6). Medicare program manuals are posted on the 
Internet at http://www.cms.gov/pubforms/progman.htm. Program 
transmittals and program memoranda are posted at http://www.cms.gov/
pubforms/transmit/transmit.htm.
    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 (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 decision, coverage decisions are made at the 
discretion of the local contractors. Frequently, local contractors 
publish local medical review policies (LMRPs) to provide guidance to 
the public and medical community that they service.
    Contractors develop these local medical review policies by 
considering medical literature, the advice of local medical societies 
and medical consultants, and public comments. Our instructions 
regarding the development of local medical review policies appear in 
section 2.3 of the Program Integrity Manual (CMS Pub. 83).
    These LMRPs explain when an item or service will (or will not) be 
considered ``reasonable and necessary'' and thus eligible (or 
ineligible) for coverage under the Medicare statute. If a contractor 
develops an LMRP, its LMRP applies only within the area it serves. 
While another contractor may come to a similar decision, we do not 
require it to do so. An LMRP may not conflict with a national coverage 
decision once the national coverage decision is effective. If a 
national coverage decision conflicts with a previously established 
LMRP, the contractor must change its LMRP to conform to the national 
coverage decision. A contractor may, however, make an LMRP that 
supplements a national coverage decision where the national coverage 
decision is silent on an issue. The LMRP may not alter the national 
coverage decision.

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B. Recent Legislation

    Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Public 
Law 105-33, 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 
in connection with the following:
     Beneficiary information required to be submitted with each 
claim or order for laboratory services.
     The medical condition for which a laboratory tests is 
reasonable and necessary (within the meaning of section 1862(a)(1)(A) 
of the Act).
     The appropriate use of procedure codes in billing for a 
laboratory test, including the unbundling of laboratory services.
     The medical documentation that is required by a Medicare 
contractor at the time a claim is submitted for a laboratory test (in 
accordance with section 1833(e) of the Act).
     Recordkeeping requirements in addition to any information 
required to be submitted with a claim, including physicians' 
obligations regarding these requirements.
     Procedures for filing claims and for providing remittances 
by electronic media.
     Limitations on frequency of coverage for the same services 
performed on the same individual.

II. Provisions of the March 10, 2000 Proposed Rule

    In the March 10, 2000 proposed rule, we set forth uniform national 
coverage and administrative policies for clinical diagnostic laboratory 
services payable under Medicare Part B. These proposed policies were 
designed to promote Medicare program integrity and national uniformity 
and simplify administrative requirements for clinical diagnostic 
laboratory services. These regulations do not provide, or purport to 
provide, any immunities or safe harbors. Additionally, these 
regulations do not limit any criminal, civil, or administrative law 
enforcement and overpayment actions. These Medicare policies apply to 
all Medicare contractors processing Part B laboratory claims, including 
fiscal intermediaries.
    The preamble to the March 10, 2000 proposed rule discussed the 
composition of the Committee, the guidelines the Committee followed in 
making recommendations, and the consensus of the negotiating Committee. 
Most of the provisions of the rule will be implemented through our 
instructional issuance system rather than codified in regulations, but 
were discussed in the preamble to the March 10, 2000 proposed rule 
nonetheless. A summary of the preamble of the March 10, 2000 proposed 
rule is as follows:
     Information required with each claim.

--Claims processing requirements change regularly; therefore, we 
encourage readers to refer to the claims processing sections of the 
Medicare Carriers Manual (sections 3005 and 3999, exhibit 10) and 
Medicare Fiscal Intermediary Manual (section 3605 and Addendum L) in 
order to keep current regarding the specific policies related to data 
elements. These manuals are posted on the Internet at http://
www.cms.gov/pubforms/progman.htm.
--We proposed not to require that diagnostic information be submitted 
with every claim at this time. However, we encourage physicians to 
voluntarily provide diagnosis information (either the reason for the 
visit or the reason for the test) with the order, and we encourage 
laboratories to submit information that they receive with the claim.
--In order to promote uniformity, we proposed that the date of service 
for laboratory tests that is reported on the claim be the date the 
tested specimen was collected. The person obtaining the specimen must 
furnish the date of collection of the specimen to the entity billing 
Medicare.

     Medical conditions for which a test may be reasonable and 
necessary.

--The March 10, 2000 proposed rule discussed the uniform process that 
the Committee used in developing 23 national coverage decisions. We are 
not codifying the national coverage decisions (NCDs) so that they could 
be updated in a timely manner as appropriate to accommodate changes in 
technology, coding, or national practice standards. We used the 
following process to develop the NCDs:
    ++ Seeking input from relevant national medical specialty societies 
and voluntary health agencies through the American Medical Association 
representative.
    ++ Reviewing relevant scientific literature and practice 
guidelines.
    ++ Reviewing existing local medical review policies, as well as any 
existing relevant templates for local policies developed by a task 
force of carrier medical directors.
    ++ Soliciting comments on the draft policies through an Internet 
posting from November 4 through 11, 1998.

--The policies followed a uniform format that Included a narrative 
description of the test, panel of tests, or group of tests addressed in 
the NCD; clinical indications for which the test(s) may be considered 
reasonable and necessary and not screening for Medicare purposes; 
limitations on use of the test(s); and diagnosis codes from the 
International Classification of Diseases, Ninth Revision, Clinical 
Modification (ICD-9-CM codes); reasons for denial (the content of which 
was not negotiated by the Committee); sources of information on which 
the decision is based; and coding guidelines.
    The ICD-9-CM codes were displayed in one of three sections. The 
first section lists covered codes--those for which there is a 
presumption of medical necessity but the claim may be subject to 
review. The second section lists diagnosis codes that are never 
covered. The third section lists codes that generally are not 
considered to support a decision that the test is reasonable and 
necessary, but for which there are limited exceptions. Additional 
documentation could support a decision of medical necessity and must be 
submitted by the ordering provider and accompany the claim.
    The national coverage decisions apply nationwide and are binding on 
all Medicare carriers, fiscal intermediaries, peer review 
organizations, health maintenance organizations, competitive medical 
plans, and health care prepayment plans for purposes of Medicare 
coverage. In accordance with section 522 of the Medicare, Medicaid and 
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), 
Beneficiaries who file for review of NCDs on or after October 1, 2001 
may appeal to the Department of Health and Human Services Appeals Board 
for review.

--The policies may be updated and new laboratory policies developed 
under the Medicare national coverage process that was published April 
27, 1999 (see 64 FR 22619). A copy of this general notice is posted on 
the Centers for Medicare & Medicaid Services Internet site at http://
www.cms.gov/coverage/8a1.htm

     Appropriate use of procedure codes.


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--We clarified that the term screening or screen in Current Procedure 
Terminology (CPT) Codes does not necessarily describe a test performed 
in the absence of signs or symptoms of an illness, disease, or 
condition.
--We clarified use of the -59 modifier as an indication for claims for 
multiple billings of the same CPT code for the same beneficiary for the 
same day when those services are medically necessary.

     Documentation and recordkeeping requirements.

--We proposed adding language to the Code of Federal Regulations (CFR) 
to clarify the documentation physicians and laboratories, respectively, 
are required to maintain.
--We proposed CFR provisions clarifying that if the documentation 
submitted by the entity submitting the claim is inadequate, we will 
seek information directly from the ordering physician.
--We clarified that we do not require the signature of the ordering 
physician on a requisition for laboratory tests. However, documentation 
that the physician ordered the test must be available upon our request.
--We summarized the various record retention requirements that 
presently exist.

     Procedures for filing claims.

--We clarified that the entity submitting the claim may assign an 
appropriate diagnosis code to a narrative, even if there is not an 
exact match between the code descriptor and the narrative the 
laboratory received from the ordering physician.
--We clarified that until standards permitting eight ICD-9-CM codes are 
implemented, Medicare contractors, whose systems accept fewer than 
eight ICD-9-CM codes in the diagnoses field, would permit the 
laboratory to submit additional codes in the narrative field.
--We encourage matching of procedures to diagnoses, but we clarified 
that claims would not be denied solely because there is no matching of 
diagnosis and procedure codes on the claim form. In lieu of identifying 
a noncovered service through matching noncovered diagnoses to specific 
procedures on a claim, we also proposed that laboratories have the 
option of submitting a separate claim for a procedure that is not 
covered by Medicare.

     Limitation on frequency.

--We proposed to issue instructions that state February 21, 2002 that 
contractors may not use a frequency screen that could result in a 
frequency-based denial unless information published by us or our 
contractors includes an indication of the frequency that is generally 
considered reasonable utilization of that test for Medicare purposes.
--We proposed to clarify the CFR provision by including the existing 
requirements related to automatic denials from the manual in the CFR.
--We solicited new ideas for addressing the problem of notification of 
beneficiaries of potential overutilization of testing.
--We proposed to issue instructions February 21, 2002 that all Medicare 
contractors consistently use remittance advice language that identifies 
the reason for denial as excess frequency when that is the reason for 
denial.

     We clarified that the limitation on liability provisions 
that are currently found in section 1879 of the Act, 42 CFR part 411, 
subpart K, section 7330 of the Medicare Carriers Manual, section 3440 
through 3446.9 of the Fiscal Intermediary Manual, and any currently 
applicable rules are equally applicable to laboratory services.
    The changes we proposed to make to Sec. 410.32 are set forth as 
follows:
     We proposed to redesignate paragraph (d) introductory text 
as paragraph (d)(1), and we proposed to add a heading.
     We proposed to redesignate paragraphs (d)(1) through 
(d)(7) as paragraphs (d)(1)(i) through (d)(1)(vii).
     We proposed to add a new paragraph (d)(2) to Sec. 410.32 
that would outline documentation and recordkeeping requirements related 
to clinical diagnostic laboratory tests. The documentation and 
recordkeeping requirements read as follows:
    ++ Paragraph (d)(2)(i) would specify that the physician (or 
qualified nonphysician practitioner) who orders the service must 
maintain documentation of medical necessity for the service in the 
beneficiary's medical record.
    ++ Paragraph (d)(2)(ii) would require the entity submitting the 
claim to maintain documentation it receives from the ordering physician 
and information documenting that the claim submitted accurately 
reflects the information it received from the ordering physician.
    ++ Paragraph (d)(2)(iii) would authorize the entity submitting the 
claim to request additional diagnostic and other medical information 
from the ordering physician to document that the services it bills are 
reasonable and necessary. This request must be relevant to the medical 
necessity of the specific test(s), and take into consideration current 
applicable rules and regulations on patient confidentiality.
     We proposed adding a new paragraph (d)(3) to Sec. 410.32 
relating to claims review.
    ++ Paragraph (d)(3)(i) will specify that the entity submitting the 
claim must provide documentation of the physician's order for the 
service billed, showing accurate processing and submission of the 
claim, and diagnostic or other medical information supplied to the 
laboratory by the ordering physician or qualified nonphysician 
practitioner, including any ICD-9-CM code or narrative description 
supplied.
    ++ Paragraph (d)(3)(ii) will specify that if the documentation 
submitted by the laboratory does not demonstrate that the service is 
reasonable and necessary, we will provide the ordering physician 
information sufficient to identify the claim being reviewed and request 
from the ordering physician those parts of the beneficiary's medical 
record that are relevant to the claim(s) being reviewed. If the 
documentation is not provided timely, we will notify the billing entity 
and deny the claim.
    ++ Paragraph (d)(3)(iii) will authorize the entity submitting the 
claim to request additional diagnostic and other medical information 
that is relevant to the medical necessity of the specific services from 
the ordering physician consistent with applicable patient 
confidentiality laws and regulations. h We proposed adding a new 
paragraph (d)(4) to Sec. 410.32 to outline when we may deny a claim 
without manual review.
    ++ Paragraph (d)(4)(i) will state that unless indicated in 
paragraph (d)(4)(ii), we will not deny a claim for services that exceed 
utilization parameters without reviewing all relevant documentation 
submitted with the claim.
    ++ Paragraph (d)(4)(ii) will permit automatic denial of claims when 
there is a national coverage decision, or LMRP that specifies the 
circumstances under which the service is denied, or the statute 
excludes Medicare coverage for the service, or the specific provider or 
supplier has engaged in egregious overutilization of the service and 
the claim is for that service.

III. Comments and Responses Based on the March 10, 2000 Proposed 
Rule

    We received responses from 61 commenters during the public comment 
period. The commenters included many of the members of the negotiation

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committee; other national and State organizations, such as the American 
Society of Hematology, and the Iowa Association of Pathologists; 
representatives of various laboratories and hospitals; individual 
physicians and other health care practitioners; a seniors' legal 
advocate; and a Medicare contractor medical director.

Information Required With Each Claim

    Comment: Eighteen commenters expressed concern that the proposed 
rule did not specifically require physicians to provide information 
necessary to support medical necessity. The commenters believe that 
laboratories billing Medicare will have to collect information from 
various sources to support medical necessity. The commenters proposed 
that the final rule should clearly state that physicians are required 
to provide the information necessary to support medical necessity with 
the order, if that information is needed for claims processing.
    Response: The Committee discussed when diagnostic information to 
support medical necessity must be submitted with a claim. The 
Committee's discussion focused on whether diagnostic information should 
be required on claims for all tests, even those not addressed by a 
national coverage policy or LMRP. Some Committee members emphasized 
that providing information related to the reason for the patient visit 
or for the test would be useful in evaluating patient outcomes and 
quality of care and would ensure consistency and simplicity. 
Physicians' representatives expressed concern, however, about the 
burden that may be involved in providing the information. Laboratory 
representatives expressed concern about laboratories' ability to be 
paid if the physician does not provide the information.
    The Committee concurred that this proposed rule would not 
promulgate a requirement that diagnostic information be submitted with 
every claim. While we recognize the concerns of the commenters, we 
believe that such a requirement would present significant burdens on 
some physicians. We will continue to study this issue and weigh the 
benefits of requiring diagnostic information on every claim for 
laboratory services against the burden that it would impose on 
physicians and laboratories. We welcome the public to share with us any 
specific suggestions they have for mitigating the burden on physicians 
inherent with instituting a mandatory diagnostic information 
requirement.
    In addition, we encourage physicians voluntarily to provide 
diagnostic information (either the reason for the visit or the reason 
for the test) with the order. Likewise, we encourage laboratories to 
submit information that they receive with the claim. Of course, if the 
diagnostic information is required for claims payment, such as where 
there is published national or local policy, physicians and 
practitioners are required under section 4317(b) of the BBA to provide 
diagnostic information at the time that the test is ordered.
    Comment: One commenter expressed concern about the proper procedure 
with which to handle patients who have no referring diagnosis but can 
provide complaint, symptoms, or diagnosis. The commenter believes that 
not having a process to handle those situations may result in the 
patient experiencing delay or postponement of the service.
    Response: For situations in which the patient does not present with 
a referring diagnosis but is able to provide complaint, symptom(s), or 
diagnosis, the proposed rule stated that the patient should be coded to 
the highest level of specificity that corresponds to his/her state of 
health. That is, the physician should provide this information (in 
narrative or code) to the laboratory, and the laboratory should report 
the complaint or symptom as one of the diagnoses on the claim. The 
national coverage decisions in this final rule include appropriate ICD-
9-CM codes for relevant signs and symptoms in the sections entitled 
``ICD-9-CM Codes Covered by Medicare Program.''
    Comment: Twenty-eight commenters addressed the issue of date of 
service, which is defined in the proposed rule as the date of specimen 
collection. Twenty-one of the commenters generally agreed with the 
proposed rule's definition, but made suggestions for additional 
information or clarifications, such as the following in the definition: 
include the time the specimen was collected; clarify how to handle 
archived specimens and collections that span a 24-hour time period; 
specify that the entity collecting the specimen be responsible for 
reporting the date of service; and ensure that the laboratory is not 
held liable if an inaccurate date was reported on Medicare claims.
    One commenter suggested that laboratories should be given the 
flexibility to also define date of service as the date of accession in 
cases for which date of collection is not available.
    Six commenters were not in favor of the proposed definition on date 
of service and submitted suggestions about how the date of collection 
may be redefined. Three commenters suggested that the definition be 
changed to the date of accession. Two commenters suggested that the 
definition be changed to the date the test results were reported. In 
addition, one commenter suggested that laboratories be given the 
flexibility to choose the date of service as either the date of 
collection, date test results were reported or the date of accession in 
the laboratory. One commenter suggested that we reserve the dates of 
service issue for further study and not proceed with finalization of 
the proposal in this rule.
    Response: The date of service is a required data field for 
laboratory claims. A laboratory service may take place over a period of 
time. That is, the date the physician orders the test, the date the 
specimen is collected from the patient, the date the laboratory 
accesses the specimen, the date of the test, and the date results are 
produced may not be the same. For example, often several days elapse 
between taking a sample and producing results in microbiology tests 
that are cultured. The Committee discussed what ``date of service'' 
laboratories must report on claims for clinical diagnostic laboratory 
services. To ensure equitable treatment of beneficiaries and providers, 
as well as to promote national claims processing consistency, it is 
necessary that all laboratories report this date consistently.
    We are committed to establishing a national coverage policy 
regarding the date of service for Medicare claims that will promote 
program integrity and national uniformity, yet minimize the burden on 
laboratories. Laboratory representatives reported that some laboratory 
computer systems are programmed to report the date of acquisition of 
the specimen or the date of accession (the date the test is entered 
into the computer system), in the date of service field on the claim 
form. In addition, Medicare issued Program Memorandum A-95-4 in April 
1995 that instructed hospital-based laboratories to report the date of 
performance as the date of service for automated multi-channel tests.
    We believe that the date of collection most closely relates to the 
date the test was ordered and that the use of only one date of service 
is consistent with the goal of promoting program integrity and national 
uniformity. We also agree that in order to promote national uniformity, 
the claims processing instruction implementing this provision needs to 
include clarifications regarding handling of special circumstances, 
such as archived specimens and tests requiring extended acquisition 
time.
    For specimen collections that span more than a 24-hour period, the

[[Page 58792]]

implementing instructions will clarify that the entity performing the 
collection should define the date of service as the date the collection 
began. 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.
    One commenter suggested that the time of specimen collection also 
be reported. We do not see the need for this information in processing 
Medicare claims. Further, the computer software used by the industry 
and us for claims processing does not include a field to report this 
information. Thus, the addition of specimen collection time as a 
required element on Medicare laboratory claims would result in a 
substantial cost for all involved parties. The commenter did not 
identify benefits from this addition that were commensurate with the 
costs. Consequently, we are not adopting this change.
    Several of the laboratory representatives commenting on this issue 
expressed concerns with the potential problems that may arise when the 
entity collecting the specimen fails to comply with the requirement to 
supply the specimen collection date. The implementing instruction for 
this provision will carefully emphasize the requirement to those 
collecting specimens to report the date of collection. We are 
optimistic that after adequate education from us and the Committee 
member organizations, such as the American Medical Society and national 
laboratory organizations, most of those collecting specimens for 
laboratory testing will take care to report required information. We do 
not believe that it is consistent with the statutory requirement to 
promote national uniformity to permit a variety of means to report the 
date of service.
    We note, however, that we are providing a grace period of up to 12 
months after the effective date of the final rule to accommodate any 
system changes required by the policy changes or clarifications 
resulting from the provisions of this rule. Entities that want to 
obtain the benefit of a grace period to permit additional time to 
implement computerized system changes must contact us in writing 90 
days before the effective date of the provision(s) they are not able to 
implement timely.
    The request for a grace period must include a description of the 
nature of the system change not able to be implemented timely, a 
description of the actions the entity has taken in an effort to 
implement timely, date upon that the entity will be able to implement 
fully, and a workplan with a timeline providing a detailed description 
of the acts which the entity shall undertake to accomplish full 
implementation and the dates by which acts shall be performed. We will 
review the submittal and advise the entity if we grant or deny the 
request for a grace period. We may grant or deny the request for a 
grace period at our discretion. Notwithstanding the foregoing, we may 
terminate at any time any grace period already provided if we determine 
that the entity has not acted in good faith or we determine the entity 
has failed to perform any of the conditions upon which we agreed to 
extend a grace period.
    If we need additional time to implement system changes associated 
with a particular provision of this rule on a nationwide basis, we well 
issue a program memorandum detailing the rationale for the extension 
and provide a new effective date.
    Thus, laboratories will have up to 24 months (12 months delayed 
effective date and up to 12 months grace period for system changes) 
after publication of the final rule to achieve system modification to 
submit claims in accordance with the final policy on date of service. 
We believe this extended time before implementation will ease any 
anticipated problems with the reporting of the specimen collection 
date.

Medical Conditions for Which a Test May Be Reasonable and Necessary

    Comment: One commenter expressed concern about designating the 
coverage policies included in the addendum to the proposed rule as 
national coverage determinations. The commenter requested that national 
coverage determination status not be conferred to the 23 coverage 
policies because this would render them unchallengeable.
    Response: Section 4554 of the BBA specifies that the negotiated 
rulemaking develop national coverage policies for clinical diagnostic 
laboratory services. The statute goes on to state that the rules 
consider the medical conditions for which a laboratory test is 
reasonable and necessary (within the meaning of section 1862(a)(1)(A) 
of the Act).
    Our regulations do not use the term ``national coverage policies'' 
in developing policies that describe the medical conditions for which a 
test is reasonable and necessary. Rather, Sec. 405.860 defines national 
coverage decisions (NCDs) in this fashion. Specifically, the section of 
the regulation states, ``CMS makes NCDs either granting, limiting, or 
excluding Medicare coverage for a specific medical service, procedure, 
or device. NCDs are made under section 1862(a)(1) of the Act or other 
applicable provisions of the Act.'' We believe that the Congress by 
requiring the Secretary to adopt ``national coverage and administrative 
policies for clinical diagnostic laboratory tests under part B of title 
XVIII,'' clearly intended the coverage policies developed under this 
rule to be considered as NCDs. We believe that to not confer NCD status 
on these policies would conflict with the statutory intent of section 
4554(b) of the BBA.
    We note, however, that the policies are developed to provide 
flexibility in all but a very limited number of diagnoses. That is, the 
policies have been constructed in a fashion to permit a Medicare 
contractor to consider coverage of additional indications on a case-by-
case basis.
    The Committee consensus includes the restatement of existing 
Medicare program requirements that contractors consider all information 
that is submitted with a claim. The policies include very few diagnoses 
that may not be covered under any circumstances in the section entitled 
``ICD-9-CM Codes Denied.'' Codes included in the list entitled ``Codes 
That Do Not Support Medical Necessity'' may be covered when they are 
accompanied by sufficient medical justification for the test for a 
particular patient's condition.
    Thus, the commenter's concern that NCD status would establish an 
irrefutable barrier to coverage is not inherent in the NCDs as 
negotiated. Moreover, section 522 of BIPA includes a provision to 
provide for review of NCDs with regard to requests for review of NCDs 
filed on or after October 1, 2001. Under the provisions of section 522 
of BIPA, a beneficiary who is adversely affected by an NCD may request 
a review with the Department of Health and Human Services Appeals Board 
(DAB). The DAB may take evidence, consult with appropriate scientific 
and clinical experts and will look at the reasonableness of the 
determination. Final decisions of the DAB are subject to judicial 
review. Thus, the policies will be reviewable.
    Comment: One commenter expressed concern that the March 10, 2000 
proposed rule did not specifically state that a laboratory is not 
required to provide an advance beneficiary notice with respect to the 
ICD-9-CM codes that are listed in the category ``ICD-9-CM Codes 
Denied.''
    Response: The diagnoses listed in the section entitled ``ICD-9-CM 
Codes Denied'' are codes that are not covered by Medicare for a variety 
of reasons. For example, some codes are excluded because they are 
screening services;

[[Page 58793]]

others are listed because they are services to caretakers rather than 
beneficiaries; another is based on the hearing aid exclusion. Advance 
Beneficiary Notices (ABNs), with respect to laboratory services, are 
required only for claims that the provider or supplier believes may not 
be covered by Medicare based on section 1862(a)(1) of the Act 
(reasonable and necessary exclusion).
    Historically, Medicare's exclusion of screening services has been 
attributed to section 1862(a)(7) of the Act. In a 1988 Program 
Memorandum (AB-88-2), we stated that we consider the 1862(a)(7) of the 
Act exclusion to be the basis for denial of screening services. Thus, 
under current policy, providers or suppliers are not required to 
provide the beneficiary with an ABN before to billing them for 
screening tests that are provided for the diagnoses listed in the 
section entitled ``ICD-9-CM Codes Denied.'' However, we believe that 
advance notice to beneficiaries of that liability is prudent, and we 
encourage providers and suppliers to voluntarily notify beneficiaries 
that they will be liable for the cost of the tests.
    We are, however, reconsidering whether to exclude screening tests 
based on section 1862(a)(7) of the Act rather than section 
1862(a)(1)(A) of the Act. We are concerned that it may not be in the 
best interest of our beneficiaries to permit providers and suppliers to 
bill them for screening services without advance notice. Should we 
issue a change to the policy, laboratories will be required to issue 
ABNs for services that are not covered based on the diagnoses in the 
list that are screening services. Any such change would be 
prospectively effective.
    Comment: Two commenters addressed the fact that the 23 tests 
identified in the national coverage decision represented 60 percent of 
the volume of Medicare outpatient laboratory testing. The commenters 
requested information about what percentage of Medicare outpatient 
laboratory payments is represented by the 23 laboratory services.
    Response: We performed an analysis on the 1999 bills that were 
processed by the Medicare carriers. This database does not include the 
laboratory claims processed by hospital-based laboratories. In this 
data set, the 63 laboratory tests that make up the 23 services 
represent 43 percent of carrier lab services and 51 percent of carrier 
laboratory payments.
    Comment: Two commenters expressed concern with the development of 
policies using both an inclusionary and exclusionary basis. They noted 
that using two different forms of logic in the development of computer 
edits is costly. They suggested that we re-evaluate the benefits of 
this approach relative to the benefits.
    Response: We decided to display the diagnosis codes in the coverage 
policy for blood tests on an exclusionary basis. That is, rather that 
list the ICD-9-CM diagnosis codes than presumptively support medical 
necessity of a blood count, they listed the codes for which a blood 
count would not be presumptively medically necessary. We decided to use 
the exclusionary approach for listing the codes when the list of codes 
that supported medical necessity was considerably larger than the list 
of those that did not. Thus, blood counts was the only test that was 
developed using the exclusionary approach.
    We note that the coverage policy for blood counts was developed in 
the same manner as all other tests. That is, based on scientific 
evidence, we listed those conditions that are indications for the test, 
or the inclusionary approach. It was for reasons of administrative 
simplicity that we displayed the codes in an exclusionary manner. Thus, 
any organization developing its own internal edits is free to edit 
using an inclusionary approach of computer logic by listing the codes 
that are not displayed as excluded.
    Comment: One commenter suggested that the narrative indications and 
the ICD-9-CM codes contained in the policies needed to be reviewed for 
consistency in all sections. The commenter believes that not all codes 
that can be used for the indications have been included in the list for 
``ICD-9-CM Codes Covered by Medicare Program.'' However, the commenter 
did not make specific suggestions for changes.
    Response: During the development of the proposed policies, we made 
a valiant effort to ensure that the coding corresponded to the 
indications included in the NCDs. This effort included development of 
the initial list of codes by an interdisciplinary workgroup that 
included at least one ICD-9-CM coding expert designated by the American 
Health Information Management Association, as well as multiple 
physicians, including Medicare contractor medical directors who are 
familiar with coding from their claims analysis activities. After the 
workgroup produced the draft NCDs, they were posted on the Internet for 
public comments.
    Several of the public comments related to coding suggestions, which 
the Committee took under advisement in making its final 
recommendations. We assigned a team of coders and physicians to review 
the recommended policies as well before they were published as proposed 
policies in the Federal Register.
    In addition, to help ensure a complete listing of codes, we 
specifically solicited comments on the policies from the public in the 
preamble to the proposed rule. However, in that preamble we explicitly 
stated that requests for changes should be accompanied by scientific 
evidence supporting the request. We encouraged commenters ``to submit, 
with their comments, copies of medical literature supporting their 
recommendation for change * * *''
    We received a number of comments regarding specific codes that 
members of the public believe were appropriate changes to the lists. 
None of the requests or comments regarding coding changes was 
accompanied by supporting scientific evidence, however. As discussed 
more fully in subsequent comments, we carefully reviewed each of these 
suggestions using a team of our physicians and coding experts and made 
appropriate decisions regarding their inclusion in the list based on 
the indications described in the policies.
    We believe the use of the Committee to develop the initial list of 
covered codes, together with the opportunity for public comment both 
during the Committee meetings and in response to the March 10, 2000 
proposed rule provides adequate assurances that the list of codes is 
appropriate. If members of the public have additional suggestions, we 
invite them to use the national coverage process to request specific 
changes for the future.
    Comment: One commenter expressed concern with the language in the 
``Reasons for Denial'' section relating to Food and Drug Administration 
(FDA) approval or clearance of tests. The commenter believes that there 
are additional exceptions beyond the Category B Investigation Device 
Exemption (IDE) noted in the March 10, 2000 proposed rule. The 
commenter suggested that the language provide for other exceptions. 
Further, the commenter requested that we specify the procedures that 
would apply to this section through an additional document that would 
be subject to notice and comment.
    Response: The last bullet in the Reasons for Denial section of the 
proposed policies states that ``Tests that require FDA approval or 
clearance will be denied as not reasonable and necessary if FDA 
approval or clearance has not been obtained, except for those having a 
Category B Investigational Device Exemption (IDE). Coverage of

[[Page 58794]]

Category B IDE devices is left to contractor discretion. (See 60 FR 
48425, September 19, 1995).'' The purpose of including the reasons for 
denial was to provide information that may be helpful to users of the 
policy. We note that this section was not negotiated by the Committee 
and included general policies of Medicare that apply to various types 
of services rather than being specific to laboratory services.
    Subsequent to the publication of the March 10, 2000 proposed rule 
we published a policy on Medicare coverage of services under clinical 
trials. This policy was published on our coverage web site on the 
Internet
(http://www.cms.gov/coverage/8d.htm) and in Program Memorandum AB-00-89 
and Coverage Issues Manual Section 30-1. The national coverage decision 
that related to clinical trials provides for coverage of routine costs 
incurred during certain clinical trials. Thus, as the commenter noted, 
there are other exceptions to FDA approval. As part of implementation 
of this policy, we will be modifying our regulations governing coverage 
of IDEs that was referenced in this bullet. We believe it is 
appropriate to remove this bullet from the reasons for denial section 
at this time. We should point out, however, that we will continue to 
consider FDA approval when appropriate in making coverage 
determinations on Medicare claims.
    Comment: One commenter noted that none of the coverage policies 
considered family history as a medically necessary reason for a test. 
The commenter believes that in a limited number of diseases family 
history should be included as a basis for diagnostic testing, but did 
not identify any specific conditions.
    Response: The policies have been developed based on Medicare's 
long-standing interpretation of sections 1862(a)(1)(A) and 1862(a)(7) 
of the Act. Section 1862(a)(1)(A) of the Act provides that Medicare 
payment may only be made for services that are reasonable and necessary 
for the diagnosis or treatment of illness or injury. Section 1862(a)(7) 
of the Act excludes Medicare coverage of routine physical checkups. We 
have interpreted this to exclude routine testing provided during such a 
physical checkup. Thus, all of the policies were developed based on the 
concept that tests that are performed when no specific sign, symptom, 
or diagnosis is present and when the patient has not been exposed to a 
disease are excluded from coverage as screening services. (See Coding 
Guideline #2.)
    We, as well as many members of the Committee, recognize that there 
may be many instances when testing of beneficiaries in the absence of 
specific signs, symptoms, diagnosis, or exposure to disease is good 
health care. The value of many preventive services and screening tests, 
particularly in the case of family history of disease is well 
documented. The exclusion of family history was not based on a belief 
by the Committee or us that such testing should not be performed.
    We are considering generating an internal request for a national 
coverage decision addressing the role of family history as a medical 
justification for a test being reasonable and necessary under our 
national coverage decision process. National coverage decisions are 
evidence-based decisions. If, after careful analysis, we believe there 
is a basis for covering screening services, we will post a notice on 
our coverage page on the Internet to allow the public an opportunity to 
participate by submitting evidence for our further consideration.
    Comment: One commenter expressed concern that certain pre-operative 
tests were not included in the proposed policies. The commenter 
explained that surgeons and other involved physicians will be bound by 
unreasonable and inflexible protocols that impose barriers to prudent 
management of an individual patient about to undergo surgery.
    Response: The coverage policies negotiated by the Committee are 
evidence-based policies. In situations in which the scientific evidence 
supports the administration of tests, such as blood counts, prothrombin 
time and partial thromboplastin time, before surgery, the policies 
provide for coverage of these tests.
    There are a number of other tests, however, that are routinely 
administered to all patients about to undergo surgery in some 
hospitals. We note that the value of that routine testing for all 
patients undergoing all surgery is questionable. For example, a recent 
study of pre-operative testing of cataract patients showed that the 
routine testing did not affect the outcome of the patients. (The New 
England Journal of Medicine 342 (2000): 168). Based on our discussion 
with physicians on this issue, we have concluded that there is not 
consensus among physicians regarding the appropriateness of furnishing 
a broad spectrum of tests to seemingly well individuals merely because 
they are about to undergo surgery.
    We believe that the proposed policies developed by the Committee 
appropriately handle the issue of pre-operative surgery given the 
constraints of the law related to screening that are discussed above. 
That is, tests furnished to patients who present with signs, symptoms, 
or history of disease are covered for those conditions. Although 
screening individuals without signs, symptoms, or past history may be 
good medical practice, we do not believe it is a service that is 
covered by the Medicare program.
    However, we are interested in continuing to study this issue. We 
encourage the public to use the national coverage process discussed 
elsewhere in this document to forward to us any scientific literature 
related to improvements in outcomes associated with administering 
specific pre-operative laboratory tests routinely to Medicare patients.
    Comment: One commenter expressed concern that the proposed policies 
may not be appropriate for certain populations. The commenter was 
particularly concerned that the proposed policies did not address the 
specific needs of certain socioeconomic or ethnic groups.
    Response: We acknowledge that the proposed policy does not 
generally address specific socioeconomic or ethnic groups. Generally, 
additional testing of particular socioeconomic or ethnic groups is 
based on higher propensity for a disease state, which is considered 
screening. Rather, the policies were designed to identify the specific 
medical indications (signs, symptoms, or disease) for testing that were 
supported by the scientific literature. However, the policies were not 
designed to be an irrefutable list of diagnoses that may warrant a 
particular test. Diagnoses, other than those listed in the section 
entitled ``ICD-9-CM Codes Denied,'' or more frequent tests may be 
covered on an individual basis when they are supported by medical 
justification submitted with the claim.
    Comment: One commenter suggested that the title of the list of 
codes called ``ICD-9-CM Codes Denied'' be changed to ``ICD-9-CM Codes 
Denied as Not a Benefit of Medicare'' to clarify that these are not 
medical necessity denials.
    Response: As noted above, we are re-evaluating our policy related 
to screening services. Thus, we do not believe it is in the best 
interest of the users of the policy to change the title of this section 
at this time.
    Comment: One commenter requested that the coding guidelines remain 
in the Coding Clinic of the American Hospital Association (AHA), rather 
than in the Federal Register. The commenter explained that AHA's Coding 
Clinic for ICD-9-CM is a more flexible means of updating codes than is 
the Federal Register, in which changes would be

[[Page 58795]]

subject to administrative processes such as notice and comment periods.
    Response: Several of the coding guidelines from the AHA Coding 
Clinic were printed in the proposed coverage policies for purposes of 
providing assistance to the users of the policies. We believe that 
repeating certain coding guidelines in the policies would clarify 
coding policies for users and would be beneficial because users would 
not need to consult alternative manuals for expeditious resolution of 
common coding questions.
    The incorporation of existing coding guidelines in the national 
coverage determinations was not intended to imply that future changes 
to the coding guidelines would be subject to publication in the Federal 
Register or make composite coding guidelines subject to the 
Administrative Procedure Act. If one of the coding guidelines that was 
printed in the proposed policies is changed in the future, the revised 
guideline may be incorporated into a national coverage decision through 
the NCD coverage process without publication in the Federal Register.
    Comment: One commenter expressed concern with coding guideline 2 on 
screening services. The commenter believes that the V01 codes, contact 
with or exposure to communicable diseases should be denied under all 
circumstances as screening. Further, the commenter suggested 
clarification of coding when a screening test shows an abnormal 
finding.
    Response: We believe that confirmed exposure to disease is not 
considered a screening test in all circumstances. For example, the 
proposed policy does not consider HIV testing of patients who have been 
exposed to HIV through needlesticks from an HIV-positive patient as 
screening. Further, Medicare Program Memorandum AB-99-04 details that 
we do not consider testing for hepatitis C infection screening when it 
is performed on patients who have been exposed to hepatitis C through a 
blood transfusion from a patient that later is determined to have 
hepatitis C. Thus, we are not adopting the commenter's first 
recommendation.
    We acknowledge that the appropriate coding for tests that were 
ordered as screening, but show abnormal findings, is an issue that 
needs clarification. We have learned that there are significant 
differences in the common coding practices between hospitals and 
nonhospital settings. We believe, however, that this issue is most 
appropriately handled by the ICD-9-CM Coding Committee. The ICD-9-CM 
Coding Committee is comprised of representatives from Centers for 
Medicare & Medicaid Services, the AHA and the National Center for 
Health Statistics, who are experts in the coding field. They are best 
able to discuss the differences among the various uses of coding 
guidelines and issue clarifications. We will ask the ICD-9-CM Coding 
Committee to include this issue on an upcoming agenda. Clarification 
will be published through the AHA Coding Clinic when the differences 
are resolved.
    Comment: One commenter made reference to coding guideline #5, which 
refers to nonspecific codes. The commenter believes the guideline does 
not define nonspecific codes, nor is the appropriate meaning of the 
term clear. The commenter requested that the final rule clarify whether 
the term ``non-specific codes'' refers to the ICD-9-CM code ``not 
otherwise specified'' (codes ending in an 8) or ``unspecified'' (codes 
ending in 9) or something else.
    Response: Coding guideline #5 states, ``When a non-specific ICD-9-
CM code is submitted, the underlying sign, symptom, or condition must 
be related to the indication for the test above.'' In including this 
statement in the coding guideline, the Committee was not addressing the 
``not otherwise specified'' or ``unspecified'' codes exclusively. 
Rather, the list of covered codes frequently includes codes that are 
very broad and encompass several related but different conditions, only 
a few of which would justify the test in question.
    For example, assume that a given code (X) is appropriate for three 
conditions (A, B, and C). An indication for test 1 is condition A. The 
coding guideline is intended to remind users that if you report code X 
for test 1, it is expected that the patient have condition A. In other 
words, if upon medical review of the chart, the contractor finds that 
the patient only has condition B, which is not included in the 
indications, it may deny the claim despite the fact that code X is 
included in the list of codes that support medical necessity.
    Comment: Many commenters suggested additional
    ICD-9-CM diagnosis codes be added to the various policies. The 
commenters generally did not provide rationale for the suggestions and 
none of the requests were supported with scientific evidence as we 
specifically requested in the preamble of the March 10, 2000 proposed 
rule. In short, the commenters asserted the policies were incorrect or 
incomplete without providing explanation or support for their concern.
    Response: As described in the preamble to the March 10, 2000 
proposed rule and in response to another comment above, the Committee 
developed the policies in a systematic and uniform manner. The 
Committee developed the narrative portion of the NCDs based on 
scientific evidence. That is, the narrative indications for a test were 
evidence based. Once the narrative indications were developed, the 
Committee attempted to identify the ICD-9-CM codes that appropriately 
translated the narrative.
    The Committee provided a brief public comment period on the 
policies as developed by the workgroups before the full Committee 
discussion of the issue and before the rule was published by Centers 
for Medicare & Medicaid Services on March 10, 2000. During this public 
comment period, numerous suggestions for coding changes, similar to 
those received during this public comment period, were made. In 
considering these public comments, the Committee decided that unless 
the coding changes were supported by medical evidence, the Committee 
would continue to look to the narrative indications and make a 
determination if the suggested code was an appropriate translation of 
the narrative.
    It is critical that the narrative indications for the proposed 
policy and the ICD-9-CM codes that support medical necessity be 
consistent. Thus, in order for us to add codes to the list of ICD-9-CM 
codes that support medical necessity, those codes must either be 
determined to be an appropriate translation of an existing indication, 
or we must add a new indication for the test in the policy narrative. 
The preamble to the March 10, 2000 proposed rule in soliciting public 
comments on the policies clearly requested that any suggested changes 
be accompanied by scientific literature supporting the change. Since 
both the Medicare NCD process and the negotiating committee use 
evidence-based decision making, it would not be appropriate to use 
opinion-based decision making to change the proposed policies in 
responding to the public comments. Therefore, we believe the approach 
similar to that taken by the negotiating committee in handling the 
comments it received from the public is a reasonable and appropriate 
means of addressing the suggestion for coding changes that were 
submitted to us during the public comment period on the March 10, 2000 
proposed rule.
    Since none of the suggested coding changes we received on the 
proposed coverage policies was accompanied by scientific literature, we 
looked to the

[[Page 58796]]

proposed narrative indications in determining if the code was an 
appropriate addition to the ICD-9-CM list in the policy. We used a team 
of our physicians and coding experts to evaluate each of the codes that 
was suggested during the public comment period. The team carefully 
studied the narrative descriptions of the indications for the test in 
the proposed NCDs. When the suggested code was a reasonable application 
of the existing narrative, we added the code to the list.
    Our physicians acknowledged that many of the ICD-9-CM codes that 
were suggested might be clinically understandable in certain 
situations. However, gathering the scientific-evidence and conducting 
the analysis necessary to make a reasonable determination as to the 
appropriateness of adding indications to the proposed policies for each 
of the multitude of codes suggested would be a daunting task and would 
have resulted in unreasonable delay in the finalization of the 
policies. We do not believe it is appropriate to further delay adoption 
of the proposed policies to conduct this search for medical evidence to 
support unsubstantiated suggestions. However, requestors are free to 
use the national coverage decision process (published in the April 27, 
1999 Federal Register (64 FR 22619) and on the Internet at
http://www.cms.gov/coverage/8a1.htm) to request further refinement of 
the national coverage decisions.
    The following codes were suggested for addition to specific 
policies. We believe these codes are an appropriate translation of the 
indications listed in the policy and we are adding them to the ICD-9-CM 
codes covered by Medicare.

Blood glucose: 780.31, 781.0, 783.6
Digoxin: 429.2, 972.0
Fecal Occult Blood Test: 003.0, 003.1, 095.2, 095.3, 098.0, 098.7, 
098.84, 139.8, 159.0-159.9, 569.82, 569.83, 596.1, 751.1
Gamma Glutamyl Transferase: 230.7, 230.9, 642.5, 782.4, 789.1, 790.4, 
790.5, V42.7
Lipids: 278.00, 401.0-401.9, 402.00-402.91, 403.00-403.91, 404.00-
404.93, 405.01-405.99, V42.7
Prostate Specific Antigen: 236.5, 599.6, 788.30, 788.41, 788.43, 788.62
Human immunodeficiency virus testing (Diagnosis): 263.0, 263.1, 263.9, 
486
Partial thromboplastin time: 362.30, 362.31, 362.32, 362.33, 362.34, 
362.35, 362.36, 362.37, 410.0-.9, 456.8, 530.82,
Prothrombin time: 786.50, V12.51-V12.59
Iron studies: 579.8, 579.9, 713.0, 716.4-716.9, V56.0, V56.8
Thyroid: 290.3, 297.1, 333.99, 358.1, 359.5, 376.21, 376.22, 425.7

    The following codes were suggested for changes to the NCDs.
    Our physician staff and coding experts reviewed these codes. Based 
on their clinical judgment and knowledge of coding guidelines, we do 
not believe these codes appropriately stem from the indications 
included in the respective policies.

Blood counts: 300.00, 300.01, 575.6, V45.89, 715.00-715.98, 716.00, 
716.99
Blood glucose: 279.9, 357.2, 357.8, 785.1, 800.00-804.99, 805.00-
806.79, 850.00-854.19, V22.0-V22.2, V72.73-V72.84, V72.81
Iron studies: 253.5, 276.0, 276.1, 278, 282.0, 282.1, 282.2, 282.3, 
282.4, 282.5, 282.60-282.63, 282.69, 282.7, 282.8, 282.9, 283.0-283.9, 
289.0-289.9, 333.99, 564.5, 607.84, 708.8, 714.0-714.9, 715.0-715.9, 
716.0-716.3, 733, 758.0, 758.1-758.9, 775.3, 780.4, 790.4
Partial thromboplastin time: 036, 040, 041, 050, 054, 056, 078.5, 081, 
082, 083, 084, 085, 086, 087, 115, 117.3, 152.0-152.9, 162, 171, 174, 
183, 185, 188.0-188.9, 198.1, 204, 205, 206, 207, 208, 239.4, 239.5, 
250.1, 282, 283, 285.0, 287.3, 289.5, 290.40-290.43, 331.81, 345.3, 
369.1-369.9, 377.53. 377.62, 386.2, 386.5, 394.0-394.9, 395.0, 395.2, 
396.0-396.9, 397.0-397.9, 398.0, 398.90-398.99, 411.1, 411.81, 411.89, 
413.0, 413.1, 413.9, 414.00-414.05, 414.8, 414.9, 415.0, 415.11, 
415.99, 416.9, 424.0, 424.1, 424.90, 424.2, 424.3, 424.91, 425.0-425.9, 
427.0-427.9, 436, 437, 440.0-440.9, 443.0-443.9, 447.6, 452, 459.2, 
514, 555.0-555.9, 577.0, 671.9, 710, 746.00, 746.01-746.09, 746.1-
746.89, 747.1, 786.50, 789.1, 789.5, 940, 941, 942, 943, 944, 945, 946, 
947, 948, 949, 958.1, 958.4, 991.6, 992.0, 994.1, 995.0, 996.85, 
V12.51, V15.1, V42.2, V42.7, V43.2, V43.4, V43.60-V43.69
Prothrombin time: 036, 040, 050, 054, 056, 078.5, 081, 082, 083, 084, 
085, 086, 087, 115, 117.3, 162, 171, 174, 183, 185, 204, 205, 206, 207, 
208, 250.1, 282, 283, 287.3, 331.81, 410.0-410.9, 435.3, 427.5, 447.6, 
577.0, 630, 710, 747.1, 785.5, 940, 941, 942, 943, 944, 945, 946, 947, 
948, 949, 958.1, 958.4, 991.6, 994.1, 995.0, 996.85, V43.60-V43.69, 
V72.81, V72.82, V72.83, V72.84
Thyroid: 198.82, 518.5, 611.6, 780.53-780.57, 786.05, 790.6, 790.94, 
793.2, 995.0, V58.0
Digoxin: 402.00, 402.10, 402.90, 414.01, 412, 414.02, 414.03, 414.04, 
414.05, 414.10, 414.11, 414.19, 557.1, 746.1-746.6, 746.81-746.89, 
747.22, V78.8
Fecal Occult Blood: 003.20-003.24, 003.8, 003.9, 095.4-095.9, 096, 
097.0, 097.1, 097.9, 098.10-098.19, 098.2, 098.3-098.39, 098.40-098.49, 
098.50-098.59, 098.6, 098.81-098.83, 098.85, 098.89, 139.0, 139.1, 
751.2, V12.79, V82.8
Gamma Glutamyl Transferase: 230.0-230.6, 231.0-231.9, 232.0-232.9, 
233.0-233.8, 234.0, 234.9, 790.6, V11.3
Lipids: 427.0-427.2, 427.31, 427.32, 427.41, 427.42, 427.5, 427.60-
427.69, 436, 443.0, 443.1, 443.8, 443.89, 443.9, 574.00, 574.01. 
574.10. 574.11, 574.20, 574.21, 574.30, 574.31, 574.40, 574.41, 574.50, 
574.51, 574.60, 574.61, 574.70, 574.71, 574.80, 574.81, 574.90, 574.91, 
575.2-575.8, 783.1, V67.51
Glycated Hemoglobin/Protein: 359.6
Prostate Specific Antigen: 188.8, 222.2, 584.5-584.9, 596.0-596.9, 
599.1, 600, 606.0, V71.1, V76.44

    Comment: One commenter submitted a list of pregnancy-related codes 
for addition to the codes identified as medically necessary for human 
chorionic gonadotropin (HCG), quantitative.
    Response: In analyzing requests for additions of codes to the list, 
we have generally looked to the indication section of the proposed 
policies. The indication section of the HCG proposed policy states that 
HCG is useful for diagnosis of pregnancy and pregnancy-associated 
conditions. We note that the proposed policy is exclusively 
quantitative HCG (CPT code 84702). The proposed policy is not 
applicable for qualitative HCG. Based on review of scientific evidence, 
such as textbooks (Clinical Interpretation of Laboratory Tests by 
Frances K. Widen, M.D.) and advice of medical consultants, we believe 
the language in the indications of the proposed policy relative to the 
utility of quantitative hCG for diagnosing pregnancy is overly broad 
and inaccurate. Pregnancy tests for the diagnosis of pregnancy use 
qualitative methods of identifying HCG, rather than quantitative 
methods. Quantitative HCG in pregnant patients is useful to monitor 
patients with suspected complications of pregnancy, such as ectopic or 
molar pregnancy.
    We believe the Committee had this understanding of the policy in 
that the list of covered codes included vaginal bleeding, molar 
pregnancy, missed abortion, ectopic pregnancy, threatened abortion, and 
pregnancy. Thus, the codes do not coincide with the language of the 
test being useful for diagnosing pregnancy. That is, codes that 
indicate suspected pregnancy, such as the

[[Page 58797]]

absence of menstruation, are not included.
    Consequently, we are altering the indications for the policy for 
HCG in this final rule to more precisely describe the utility of 
quantitative HCG. The final policy will read, ``In addition, HCG is 
useful for monitoring pregnant patients with vaginal bleeding, 
hypertension and/or suspected fetal loss.'' Given this revised 
indication, we believe the following codes suggested by the commenter 
should be added to the list of codes covered by Medicare: 634.0, 636.0, 
642.3, 642.4, 642.5, 642.6, 642.7, 642.9. The following codes, 
suggested by the commenter are not being included at this time: 623.8, 
626.0, 626.1, 646.5, 658.1, 658.2, 658.3, 658.4, 659.2, 659.3, V22.2. 
Further, we are deleting codes V22.0 and V22.1 from the list of covered 
codes. These codes indicate normal pregnancy. We do not believe that 
quantitative HCG is reasonable and necessary for a pregnancy that is 
confirmed as normal.
    Comment: Seventeen commenters addressed the proposed NCD on the 
collagen crosslinks test. Fifteen of the commenters generally expressed 
support for adopting the NCD on the collagen crosslinks test in the 
final rule but suggested clarification and revision in a number of 
different areas. One other commenter questioned the clinical usefulness 
and reliability of the test and concluded that Medicare should not 
reimburse it.
    Another commenter did not indicate whether or not he supported the 
proposed national policy, but expressed the view that there were 
internal inconsistencies in the policy that needed to be clarified 
before publication in the final rule. Only one of the commenters 
produced scientific evidence for their views; however, much of this 
evidence had already been reviewed the rest of the negotiating 
committee and us during the deliberations.
    Response: There was considerable discussion at the November 1998 
meeting of the negotiation Committee on this proposed policy as well. 
It also noted that this was a field that was changing rapidly. We 
believe that the evidence available supports the policy. Since the 
field is rapidly changing and there are limited and inconsistent 
findings in the literature, it is not surprising that we received 
several inconsistent comments on this proposed policy. That is, some 
commenters believe the policy is too restrictive, and others believe it 
goes beyond what is supported by the science. We note, however, that 
most of the commenters believe that the policy is basically sound, but 
they were requesting refinements. After careful studying of the 
comments and the limited additional scientific literature submitted by 
the commenters, we do not believe that the public comments have 
presented such a radically different view as to undermine the policy we 
had proposed and which was recommended by the Committee.
    Therefore, we are including the collagen crosslinks policy in the 
final rule with only minor clarification as we explain in our response 
to several of the more specific comments summarized below. We invite 
commenters to use the NCD process that was published in the April 27, 
1999 Federal Register (64 FR 22619) to request further changes in the 
policy.
    Comment: Some of the commenters expressed concern that the NCD on 
the collagen crosslinks test did not recognize that these tests may be 
useful in men who have degenerative bone loss. The commenters noted 
that while the majority of bone loss patients are women, bone loss can 
also affect men as well--especially those over 70 years of age.
    Response: We agree that the collagen crosslinks test may be useful 
in assessing or monitoring the treatment regimens of men who have 
osteoporosis, Paget's disease, or are otherwise at risk for 
degenerative bone loss. We did not intend to exclude, nor do we believe 
that the proposed NCD should be interpreted to preclude men from 
coverage of collagen crosslinks tests as long as one of the applicable 
medical indications for coverage is met. Nonetheless, we have clarified 
this point in the final rule by revising the fourth sentence of the 
``Indications'' section of the NCD to provide that ``Coverage for bone 
marker assays should be established * * * for younger beneficiaries and 
for those men and women who might become fast losers because of some 
other therapy such as glucocorticoids.''
    Comment: Nine commenters indicated that the proposed NCD on the 
collagen crosslinks test reflects that these tests may be performed on 
urine, but not on serum samples. One of these commenters stated that 
the FDA had approved the serum-based technique as ``substantially 
equivalent'' to the urine-based version and offered documentation in 
support of adding it to the urine-based collagen crosslinks test in the 
final rule. Another commenter mentioned that the serum-based technique 
might be a more reliable test of bone turnover than the urine test, but 
suggested that there was insufficient information available to 
determine whether either test was clinically useful for monitoring drug 
therapy for individuals with or at risk for bone loss.
    Response: We recognize that since the proposed Medicare NCD on 
urine-based collagen was negotiated, the FDA approved the serum 
collagen crosslinks test in February 1999 for the purpose of assessing 
or monitoring drug therapy for individuals with or at risk for bone 
loss. However, serum collagen crosslinks test was not part of the 
negotiated rulemaking. We do not believe it is appropriate to include 
additional tests that were not subject to negotiation in this final 
rule. That is, the negotiated rulemaking committee carefully selected 
the tests for which it wished to negotiate a coverage NCD.
    The commenter noted that the FDA had determined that the serum-
based technique is ``substantially equivalent'' to the urine-based 
version. The criteria the FDA uses in making determinations related to 
substantial equivalency under section 510(k) of the Food, Drug and 
Cosmetic Act is significantly different from the scientific evidence we 
consider in making ``reasonable and necessary'' determinations under 
Medicare. FDA does not require clinical data or outcomes studies in 
making a determination of substantial equivalency for the purpose of 
device approval under section 510(k) of the Food, Drug, and Cosmetic 
Act. Medicare evidence-base decisions consider medical benefit and 
clinical utility of an item or service in determining whether the item 
or service is considered reasonable and necessary under the Medicare 
program. Thus, a substantial equivalency approval under section 510(k) 
of FDA is not sufficient for making determination concerning Medicare 
coverage.
    When sufficient clinical studies have been done on the serum tests, 
we encourage the commenters to use the NCD process published in the 
April 27, 1999 Federal Register to request inclusion of serum version 
of the test in the collagen crosslinks NCD. In the meantime, in the 
absence of an NCD on the serum collagen crosslink test, Medicare 
contractors will have local discretion in deciding whether this type of 
collagen crosslinks test is medically necessary for assessing or 
monitoring bone loss therapy.
    Comment: Fifteen commenters indicated that available scientific 
evidence and clinical expert opinion support the view that contrary to 
the first paragraph of the ``Indications'' section of the proposed NCD 
on the coverage of collagen crosslinks tests, rapid bone loss 
frequently does occur

[[Page 58798]]

after age 65. In view of their concerns, the commenters have 
recommended that the first paragraph of the ``Indications section'' be 
deleted or substantially revised in the final rule.
    Response: In response to the commenters' concerns, we re-examined 
the scientific evidence considered by the negotiating Committee and 
that was submitted during the public comment period on the collagen 
crosslinks proposed NCD. In the studies we reviewed, the sensitivity 
and specificity of the biochemical markers was relatively low, and 
there are wide confidence intervals associated with the results. We 
believe these factors demonstrate the clinical utility of biochemical 
markers only for patients who are rapid bone losers.
    The commenters do not appear to dispute the determination that 
collagen crosslinks are most clinically useful only for rapid bone 
losers. Rather, the commenters believe that many patients over age 65 
are considered rapid bone losers. While several practicing physicians 
indicated that in their clinical judgment patients over age 65 
frequently are rapid bone losers, this clinical judgment was not 
supported with clinical studies to indicate the extent to which rapid 
bone loss may be a significant problem for Medicare beneficiaries age 
65 and older.
    Further, in our review of the literature, we did not find 
scientific evidence either supporting or disputing this assertion. In 
the absence of evidence to support this clinical judgment, we are not 
convinced that the policy negotiated by the Committee is inappropriate. 
In short, we find no persuasive reason to revise the proposed policy. 
Therefore, we believe that the first paragraph of the ``Indications'' 
section of the proposed NCD on this test should be included unchanged 
in the final rule except for the clarification discussed above with 
respect to men.
    We would point out, however, that the age limitation is not an 
absolute exclusion from coverage. The language in the NCD states, 
``Generally speaking, collagen crosslink testing is useful mostly in 
`fast losers' of bone. The age when these bone markers can help direct 
therapy is often pre-Medicare. By the time a fast loser of bone reaches 
age 65, she will most likely have been stabilized by appropriate 
therapy or have lost so much bone mass that further testing is 
useless.'' Thus, physicians who encounter an occasional patient age 65 
and over for whom they have reason to believe collagen crosslinks 
testing is clinically useful, may obtain Medicare coverage through 
documentation that the service is reasonable and necessary for that 
patient.
    Comment: One commenter noted that there appears to be an 
inconsistency in the proposed NCD for collagen crosslink tests because 
the list of ICD-9 codes for this policy includes multiple myeloma, but 
this condition is not included in the ``Indications'' section for this 
policy. It is suggested that these two portions of the policy be made 
consistent.
    Response: We agree that the two portions of the policy should be 
made consistent. The Committee operated under the ground rules that the 
codes included under the ``List of ICD-9-CM Codes Covered by Medicare'' 
should be an appropriate representation of the narrative indications. 
In addressing all requests for changes to the codes that were received 
during the comment period, we have consistently held that the codes 
must be a codification of a condition that was included in the 
indication section of the NCD. Therefore, we have removed ICD-9-CM 
codes 203.00 and 203.01 from the list of ICD-9-CM codes covered by 
Medicare for collagen crosslinks. If commenters believe this is an 
appropriate indication for collagen crosslinks, they may use the NCD 
process described in the April 27, 1999 Federal Register to submit 
scientific evidence in support of the change.
    Comment: One commenter also stated that if the purpose of the 
proposed NCD for collagen crosslink tests is to permit this test to be 
used to diagnose the presence of osteoporosis or the risk of developing 
it, we should determine how frequently this test may be used for this 
purpose and whether collagen crosslinks and bone mineral density tests 
may be done in the same period for diagnosing osteoporosis. Otherwise, 
the commenter noted that the predisposing conditions for osteoporosis 
should be deleted as acceptable conditions for coverage of this test, 
and only the conditions for coverage of monitoring known osteoporosis 
treatment should be allowed.
    Response: The purpose of the proposed NCD for the collagen 
crosslinks test was not to permit coverage of the test to diagnose the 
presence of osteoporosis or the risk of developing it. Rather, the 
purpose of the test, as stated in the proposed NCD, was to (1) identify 
individuals with elevated bone resorption, who have osteoporosis in 
whom response to treatment is being monitored, (2) predict response (as 
assessed by bone measurements) to FDA-approved antiresorptive therapy 
in postmenopausal women, and (3) assess response to treatment of 
patients with osteoporosis, Paget's disease of the bone, or at risk for 
osteoporosis for which treatment may include FDA approved 
antiresorptive agents, anti-estrogens or selective estrogen receptor 
moderators. We are including this language unchanged in the final rule. 
It should be interpreted to mean that all covered indications for 
collagen crosslinks in the final rule relate solely to the assessment 
or monitoring of treatment regimens for postmenopausal women, patients 
with osteoporosis, Paget's disease of the bone, or others who are at 
risk for osteoporosis. None of the covered conditions relate to the 
diagnosis of osteoporosis or the risk of developing osteoporosis.
    Comment: Fifteen commenters expressed the view that the proposed 
NCD on collagen crosslinks tests should be implemented immediately upon 
publication of the final rule without the 12-month delay in the 
effective date and the additional grace period of up to 12-months 
beyond the effective date called for in the March 10, 2000 proposed 
rule. One of the commenters stated that our reasoning in the March 10, 
2000 proposed rule for the delayed implementation that referenced the 
need for time to allow for educational efforts and computer systems 
changes to be made for the various new policies was not applicable to 
the collagen crosslinks test for several reasons. First, the commenter 
suggested that the volume of Medicare collagen crosslink test claims 
anticipated is so negligible that the immediate implementation of the 
NCD on the test would not disrupt the Medicare claims process or cause 
related education or computer systems problems. Second, the commenter 
believes that the collagen crosslinks test has a unique legal status 
that necessitates that it be excluded from the delay in the effective 
date that has been proposed for all of the clinical diagnostic test 
NCDs that have been developed. Specifically, the commenter suggested 
that the collagen crosslinks test is subject to the provisions of 
section 4106 of the BBA, which mandated national coverage for bone mass 
measurements effective July 1, 1998.
    Response: We continue to believe that the concerns expressed by the 
negotiating committee relative to the need for the delayed effective 
date to allow for important education and systems changes to be 
completed is appropriate and should be applied in the final rule to all 
of the 23 NCDs, including the one on collagen crosslink tests. We 
recognize that the volume of Medicare collagen crosslink test claims 
that may be anticipated may be small in comparison to the volume of 
Medicare

[[Page 58799]]

claims for the other 22 clinical laboratory tests, but the lower volume 
of claims expected will not preclude the need for important educational 
efforts and systems changes to be made for the collagen crosslinks 
test.
    As for the commenter's suggestion that the collagen crosslinks test 
has a unique legal status under section 4106 of the BBA that should 
allow it to be excluded from the delay in the effective date of the 
various policies, we disagree that this is the case. Section 4106(b) of 
the BBA amended the law to provide that payment for bone mass 
measurements that are covered under the new benefit must be made under 
the Medicare physician fee schedule, as provided in section 1848(j)(3) 
of the Act. We have interpreted these provisions in the interim final 
rule that was published on June 24, 1998 (63 FR 34320) on coverage and 
payment for bone mass measurements to mean that the scope of the 
benefit includes bone densitometry or bone sonometry procedures that 
are performed with devices that have been approved or cleared for 
marketing by the FDA. We did not include coverage of crosslink tests 
within the bone mass measurement benefit. Collagen crosslink tests are, 
in fact, clinical laboratory tests that are paid for under the Medicare 
clinical laboratory fee schedule, and Medicare coverage of these tests 
has been addressed under section 4554 of the BBA, which, of course, 
mandated this negotiated rulemaking process for the coverage of certain 
clinical laboratory tests. Collagen crosslinks measure bone resorption 
and are used to monitor the effectiveness of antiresorptive therapy. We 
do not believe collagen crosslinks tests are appropriately considered 
bone mass measurements.
    Comment: Ten commenters suggested that we develop a specific 
process for updating policies and to introduce additional national 
coverage decisions without having to wait for the biennial review.
    Response: It is not necessary to wait for the biennial review in 
order to request changes in the Medicare national coverage decisions. 
As we noted in the preamble to the March 10, 2000 proposed rule, 
Medicare has announced a new process for making requests for new 
Medicare national coverage decisions or for requesting changes to 
current coverage decisions. The coverage process was delineated in a 
notice in the Federal Register published April 27, 1999, and is 
available on the Internet at http://www.cms.gov/coverage/8a1.htm
    We should point out that the new coverage process includes an 
opportunity for members of the public to participate in coverage 
decisions. We post all pending coverage issues on the Internet and 
welcome the submission of evidence related to every issue. In addition, 
for some issues, we hold public meetings of the Medicare Coverage 
Advisory Committee (MCAC) to assist us in assessing the evidence. We 
have established a specific MCAC panel to address diagnostic issues, 
such as clinical diagnostic laboratory tests.
    We intend to solicit changes in the laboratory policies biennially, 
as directed in section 4554 of the BBA. In addition, we will accept 
requests for changes to current policies at any time, as long as they 
comply with the requirements in the coverage notice.
    Comment: One commenter was concerned that implementation of the 
final rule may result in denial of payment for laboratory services that 
are currently being paid by Medicare. The commenter suggested that a 
laboratory should be able to rely on the existing local medical review 
policies (LMRP) without fear of claims denial and potential government 
enforcement action until the applicable contractor changes its LMRP or 
until the proposed rule is effective.
    Response: We agree with the commenter that the final rule should 
not be enforced before its effective date. Contractors should be using 
their existing local policies until these policies become effective. 
Once these national coverage decisions become effective, contractors 
will need to use these policies as they are published. LMRPs may not 
conflict with the 23 national coverage decisions outlined. If a LMRP 
conflicts with a national coverage decision, the contractor is required 
to change it so it complies with the national coverage decision. When a 
national coverage decision is silent on an issue, such as frequency 
guidance, a contractor may develop an LMRP that supplements the 
national coverage decision. However, the LMRP may not conflict with the 
national coverage decision.

Appropriate Use of Procedure Code

    Comment: Three commenters expressed the view that it is not 
appropriate to use modifier -59 for medically necessary repeat clinical 
laboratory tests for the same CPT code for the same beneficiary on the 
same day because that modifier applies to physician procedures and not 
clinical laboratory tests. They indicated that modifier -91 is 
specifically designed for clinical laboratory tests, and is a more 
appropriate modifier to use in billing for medically necessary repeat 
tests of this type.
    Response: The issue of use of modifiers -59 and -91 can be 
confusing. Both modifiers have a place in coding repeat clinical 
diagnostic laboratory tests. Modifier -91 is appropriate when in the 
course of treatment of the patient it is necessary to repeat the same 
laboratory test on the same day to obtain subsequent test results, such 
as when a beneficiary requires repeated blood tests that were performed 
at different intervals during the same day.
    The commenters are correct that the new modifier -91 that was added 
by the American Medical Association's CPT Editorial Panel, as part of 
its year 2000 update, is specifically designed for the reporting of 
that type of repeated test. For example, if an arterial blood sample is 
drawn from a patient at three different intervals on the same day, and 
the blood testing is performed three times that same day, then CPT code 
82803, Gas, blood, any combination of pH, PCO2, P02, CO2, HC03 
(including calculated oxygen saturation), should be reported as 
follows: 82803, 82803-91, and 82803-91. We believe one of the examples 
provided in the March 10, 2000 proposed rule--Biochemical studies 
performed on different samples, for example, renins (CPT code 84244)--
is an example of when the modifier -91 is appropriate.
    The purpose of the Committee consensus on the use of modifier -59 
was to resolve coding situations that were presented to the Committee 
by the microbiology community that do not meet the definition of 
repeated tests for which modifier -91 is appropriate. They cited 
situations, for example, in which samples or cultures are taken from a 
patient from different anatomical sites, or even different wounds, and 
then are tested the same day. We believe that the use of modifier -59 
in reporting multiple claims submissions by a clinical laboratory for 
the same CPT code for the same beneficiary on the same day is the 
appropriate way to handle these situations and is consistent with 
established CPT coding conventions. We have consulted with the American 
Medical Association, the proprietors of the CPT coding system including 
modifier, in ensuring that modifier -59 is the appropriate means of 
indicating repeat laboratory test coding when there are two tests 
involving different sites. As mentioned in the preamble to the March 
10, 2000 proposed rule, a few examples of appropriate use of modifier 
-59 would be the following:

[[Page 58800]]

     Multiple blood cultures (CPT codes 87040 and 87103), 
generally 2-3 collected from different sites to document etiology of 
sepsis.
     Multiple lesion samples collected from distinct anatomic 
sites for culture for bacteria (CPT codes 87070 and 87075).
    Comment: One commenter noted that it is the experience of its 
organizations members that some Medicare contractors are not currently 
accepting the use of modifier -59, and it is suggested that we should 
issue an instruction to its contractors to ensure that they will accept 
multiple claims submitted by laboratories using modifier -59.
    Response: We agree that all Medicare contractors processing 
laboratory claims should be accepting both modifier -59 and modifier 
-91 when used appropriately in billing for medically necessary 
laboratory services for the same CPT code for the same beneficiary on 
the same day, as described above in our reply to the previous comment. 
We will clarify the use of these two modifiers in the instructions that 
we will be issuing to our contractors.
    Comment: One commenter indicated that there was a need for us to 
identify all of those clinical laboratory tests that frequently result 
in multiple tests being billed.
    Response: We do not believe that we have the expertise or 
experience to attempt to identify all of the various clinical 
laboratory tests that might warrant the use of modifier -59. If we were 
to attempt this action and make errors in omission, laboratories would 
not be able to receive payment when it may become necessary to perform 
repeat testing on patients to attend to their specific medical needs. 
We believe that it is sufficient to provide a few examples of 
appropriate use of the modifier, which we will repeat in our 
instructional issuance.
    Moreover, the Committee believes that there was not sufficient time 
and information available for them to attempt to identify all the 
various clinical laboratory tests that might warrant use of modifier 
-59. As a result, the Committee agreed that it would be sufficient to 
provide a few examples are of appropriate use of the modifier. We agree 
with the Committee that a few examples are sufficient to address the 
concern with the -59 modifier. Moreover, we believe that any attempt on 
our part to identify a comprehensive list of situations that would 
warrant the use of the -59 modifier is likely to be incomplete due to 
our lack of field experience and would thus generate additional 
concerns.

Documentation and Recordkeeping Requirements

    Comment: Three commenters expressed concern about the process by 
which diagnostic information supporting medical necessity is to be 
collected from the ordering physician. Two of the commenters suggested 
that we publish a guideline for collecting additional information from 
the ordering physician. Another commenter further suggested that our 
guideline state the baseline effort required for obtaining 
documentation by the entity submitting the claim. The commenter 
suggested that claims should be denied only if the required effort for 
obtaining the documentation has been met.
    Response: We acknowledge the burden that accompanies the task of 
collecting diagnostic information to support medical necessity. 
However, the Act requires that Medicare only pay for services that are 
reasonable and necessary. Medicare cannot pay for services that do not 
meet this standard simply because the laboratory has expended a 
specified amount of effort to obtain documentation. We have, however, 
identified a process for requesting documentation that we believe 
reduces the burden on the laboratories for collecting and submitting 
information to us.
    As part of the negotiated rulemaking process, the Committee 
established a consensus to the guidelines for documentation that 
appeared in the preamble to the March 10, 2000 proposed rule. 
Specifically, the consensus statement and proposed rule provide that 
the laboratory is responsible for maintaining information it receives 
from the ordering practitioner, and the practitioner, is responsible 
for maintaining the information in the medical record. Our initial 
request for information is made to the entity submitting the claim. 
That entity should submit whatever documentation it has in support of 
the claim.
    If the documentation provided by the entity submitting the claim 
does not demonstrate that the service is reasonable and necessary, we 
will take the following action: (1) Provide the ordering physician 
information sufficient to identify the claim being reviewed; (2) 
request from the ordering physician those parts of a beneficiary's 
medical record that are relevant to the specific claim(s) being 
reviewed; and (3) if the ordering physician does not supply the 
documentation requested, inform the entity submitting the claim(s) that 
the documentation has not been supplied and deny the claim.
    Since the entity submitting the claim will be the entity to 
experience a payment denial if documentation does not support the 
medical necessity of the claim, we agreed laboratories should not be 
precluded from requesting additional diagnostic or other medical 
information from the ordering provider. In making requests for 
additional information, laboratories must focus their request for 
additional information on material relevant to medical necessity. In 
addition, documentation requests must take into account applicable laws 
and regulations related to patient confidentiality.
    Comment: One commenter requested that we publish a quarterly 
summary that specifies the total number of tests ordered and the total 
number of tests not paid by Medicare due to lack of medical necessity 
by the ordering physician.
    Response: We question the utility of quarterly reports that specify 
the total number of tests and total number denied due to lack of 
medical necessity. We fail to see how this report would assist 
laboratories without identification of the laboratories and/or 
physicians involved. Furthermore, the commenter did not identify a 
method of distribution of this information that would be beneficial and 
reasonably priced. We are not convinced that the benefits of such a 
report would outweigh the costs.
    Laboratories are free to prepare any reports for their own use with 
the payment information they receive. For example, laboratories can 
link denial rates for failure to provide medical necessity information 
to specific clients and target educational efforts toward those 
specific problems.
    Comment: Twenty-six commenters expressed concern that the March 10, 
2000 proposed rule makes it possible for laboratories to be held liable 
for claims denial due to the lack of information supporting medical 
necessity. That is, the commenters were concerned that the laboratories 
would be the entity experiencing the loss if the physician does not 
submit the information supporting medical necessity. The commenters 
believe that the March 10, 2000 proposed rule will result in unfairness 
and financial hardships for the laboratory industry. Several commenters 
suggested that in the final rule, laboratories should not be 
financially responsible in this situation. Some commenters believe that 
the situation may be best addressed if (1) we simultaneously notify 
both the entity submitting the claim and the ordering physician that 
additional information is

[[Page 58801]]

being requested; (2) we tracks which physicians have failed to comply 
with requests for additional information; and (3) we identify a time 
frame that specifies when responses to requests need to be made. One 
commenter suggested that we create a database of medical records that 
service providers may access for claims purposes.
    Response: The commenters do not seem to recognize that the March 
10, 2000 proposed rule does not change the current provisions for 
liability on claims due to lack of information supporting medical 
necessity. Section 1862(a)(1)(A) of the Act provides that, 
notwithstanding any other provision of the Act, payment may not be made 
for services that are not reasonable and necessary for the diagnosis or 
treatment of illness or injury. Presently, all entities that bill the 
Medicare program are held liable when they bill for services and are 
not able to produce documentation of the medical necessity of the 
service. Although the Committee discussed at length the special 
circumstances related to laboratories, which frequently do not have 
direct contact with the patient, the Committee recognized that the law 
does not provide the authority to exempt laboratories from the 
provision related to medical necessity.
    In addition, we do not agree that the provision related to denial 
of claims for laboratory services when documentation is not provided is 
unfair. Rather, we believe it would be unfair to exempt laboratories 
from this provision while continuing to require it for other providers 
and suppliers. For example, durable medical equipment (DME) suppliers 
frequently do not have direct contact with beneficiaries but are 
dependent upon physician documentation of medical need in order to 
receive payment.
    Some commenters suggested that we simultaneously notify both the 
entity submitting the claims and the ordering physician that additional 
information is being requested. We are not accepting this suggestion 
for several reasons. First, in many cases, we do not have the address 
of the ordering physician at the time the initial request for 
information is made. This information will be supplied by the entity 
that submitted the claim following our initial request so that we can 
directly request additional information from the physician as is 
contemplated in Sec. 410.32(d)(3)(ii). Moreover, we believe that it 
would be confusing to request information from both the ordering 
physician and laboratory simultaneously because both the laboratory and 
the physician could send information or both can believe that the other 
is handling it. Finally, duplicate mailings to both the laboratory and 
physician are costly to the program. This appears to be a cost without 
benefit.
    Some commenters suggested that we track which physicians have 
failed to comply with requests for additional information. Similarly, 
this is a suggestion that would result in significant cost to the 
program if adopted. The commenters were not clear about how this 
information ought to be used. We do not agree that tracking these 
physicians would be beneficial. Several of the commenters suggested 
that we identify a time frame between a request for documentation from 
the carrier and denial of the claim for lack of documentation. We agree 
that physicians should be advised of the period of time that they have 
to respond to the Medicare contractor's request. Section 521 of the 
BIPA requires that the carrier or fiscal intermediary must make initial 
determinations on claims within 45 days of receipt of the claim.
    Claims subject to additional information requests on prepayment 
review must be handled within the statutory mandated time frame. In 
cases for which the initial request would have been made to the entity 
submitting the claim before the request to the physician, it is very 
likely that there will be minimal time for the physician to respond. 
Requests for additional information made on a postpayment basis is not 
subject to the time frames contained in section 521 of BIPA. In issuing 
instructions implementing this provision of the rule, we will instruct 
the contractors to identify the date by which they need information on 
claims that have not received an initial determination and provide 60 
days notice before denying a claim for failure to supply requested 
information when claims are identified for development based on 
postpayment review.
    Comment: One commenter addressed the process that would allow 
physicians to justify additional tests that may not be deemed by local 
medical review policy (LMRP) as medically necessary.
    Response: Most local medical review policy is written in a fashion 
similar to that employed by the Committee in development of the 23 
national coverage decisions contained in the addendum to the March 10, 
2000 proposed rule. That is, most LMRPs provide a list of codes for 
which medical necessity is presumed, a list of codes that are not 
covered, and a list of codes that are presumed not medically necessary. 
Contractors are required to consider any documentation that is 
submitted with the claim. Thus, a process already exists for physicians 
to justify tests that are not presumed medically necessary. Further, 
LMRPs are not binding upon the Administrative Law Judges that 
adjudicate appeals of contractor denials. Physicians may use the appeal 
process to seek payment for claims that the contractor determines are 
not justified.
    Comment: One commenter requested that a form be produced that would 
allow physicians to justify additional clinical laboratory tests that 
may not be considered medically necessary by the local LMRP.
    Response: Under current Medicare guidelines, clinical laboratories 
are already allowed, if they choose, to require that their ordering 
physicians use a specified medical documentation form in support of 
claims as the commenter has suggested. We, however, are obligated under 
the Paperwork Reduction Act to limit the reporting burden placed upon 
providers unless there is a demonstrated need for it to carry out the 
provisions of the applicable law and regulations. Since clinical 
laboratories already have the ability to require their clients to use a 
specified medical documentation form, we do not believe that it is 
necessary to require the use of such a form by all physicians for all 
of the tests that they order for their Medicare beneficiaries. It is 
possible for us to engage in this type of documentation gathering 
through use of a national certificate of medical necessity for clinical 
laboratory services. However, before we actively consider imposing this 
type of reporting burden on the public, we believe we need to research 
this proposal carefully.

Signature on Requisition

    Comment: Twelve commenters addressed the March 10, 2000 proposed 
rule's provision about signature requirements on requisitions. Seven of 
the commenters were in agreement with the March 10, 2000 proposed rule 
provision that a signature not be required on a claim and did not 
submit suggestions to us. Two of the commenters requested that we 
publish other means of indicating that a physician has ordered a 
laboratory service. Three of the commenters expressed concern that the 
March 10, 2000 proposed rule was in conflict with CLIA requirements 
that a written authorization be obtained within 30 days of a verbal 
request for the laboratory service. One suggested that we should 
require USER ID instead of physician signature while another suggested 
that another individual who has the authority to order for the 
physician be required to sign the requisition in place of the 
physician.

[[Page 58802]]

    Response: Regulations set forth at Sec. 410.32(a) require that 
diagnostic x-ray tests, diagnostic laboratory tests, and other 
diagnostic tests must be ordered by the physician who is treating the 
beneficiary for a specific medical problem and who uses the results in 
the management of the beneficiary's specific medical problem. Some have 
interpreted this regulation to require a physician's signature on the 
requisition as documentation of the physician's order. While the 
signature of a physician on a requisition is one way of documenting 
that the treating physician ordered the test, it is not the only 
permissible way of documenting that the test has been ordered. For 
example, the physician may document the ordering of specific tests in 
the patient's medical record. As stated in the preamble to the March 
10, 2000 proposed rule, we will publish an instruction to Medicare 
contractors clarifying that the signature of the ordering physician is 
not required for Medicare purposes on a requisition for a clinical 
diagnostic laboratory test.
    We also do not agree with the commenters that the March 10, 2000 
proposed rule conflicts with the CLIA requirements. Regulations 
implementing the Clinical Laboratory Improvement Amendments of 1988 
(CLIA) at Sec. 493.1105, relating to the requisition, specify that a 
laboratory must perform services only at the written or electronic 
request of an authorized person. Further, this section permits oral 
requests for laboratory services only if the laboratory subsequently 
requests written authorization for the testing within 30 days.
    Authorization does not equate to physician signature; the CLIA 
regulations provide, for example, that the patient's chart or medical 
record may be used as the test requisition. The CLIA regulations 
address this written authorization as a means of ensuring that 
laboratories are not performing tests that were not authorized. They do 
not address or conflict with the requirement that there be 
documentation of the physician's order available upon request of the 
Medicare contractor. Of course, if the physician signs the requisition 
himself, it would satisfy both the requirement in Sec. 410.32(a) and 
Sec. 405.1105.

Procedures for Filing Claims

    The Committee discussed concerns expressed by various members of 
the Committee and reached a consensus on the following three issues 
relating to ``Procedures in Filing Claims.'' These included (1) Coding 
of Narrative Diagnoses, (2) Limitation on Number of Diagnoses, and (3) 
Matching of Diagnosis to Procedure. We received no comments from anyone 
on these issues.

Limitation on Frequency

    Comment: Three commenters cited the lack of frequency limitations 
in many of the national coverage policies that had been developed in 
the March 10, 2000 proposed rule. Two commenters requested that we 
specify the allowed frequency limitations in all of the proposed 
policies. One commenter expressed support only for screens that are 
national in scope and suggested that in the absence of these national 
frequency limitations, local contractors should not be permitted to 
apply their own frequency limitations at that level.
    Response: The Committee discussed this subject and agreed to set as 
its goal the development of specific language on frequency limitations 
for the various national coverage policies drafted whenever possible to 
promote uniformity throughout the country. The Committee spent a great 
deal of time and worked very diligently on this issue, but they were 
unable to reach a consensus on specific frequency limitations for most 
of the proposed national coverage policies.
    We have continued to study the scientific evidence related to 
frequency limitations, and we do not believe that the medical evidence 
is sufficient to develop national frequency limitations for those 
policies that do not contain them at present. Further, we note that the 
public comments on the March 10, 2000 proposed rule did not include 
information supporting the addition of any specific frequency 
limitations to the national coverage policies. Contractors analyze data 
to allow them to identify what is the prevalent practice in the area. 
In the absence of scientific data to support national frequency 
limitation, we have decided to defer to local contractors in this 
regard who will base their determinations on the local practices.
    In the absence of a national coverage policy on a particular 
laboratory procedure that specifies a frequency limitation, Medicare's 
local contractors are responsible for making individual coverage 
determinations on the procedure, including, if they choose, 
establishing appropriate local frequency limitations on the procedure.
    The Committee discussed this issue and agreed that a frequency 
limitation would not result in a frequency-based denial at the local 
level unless information published by our contractor (or by us in the 
case of a national frequency limitation) includes an indication of the 
frequency that is generally considered reasonable use of that test for 
Medicare payment purposes. The contractor must consult with appropriate 
advisors, including medical specialty and other organizations, before 
developing and publishing frequency information for a clinical 
diagnostic laboratory test.
    Comment: One commenter opposed the use of frequency screens that 
result in automatic denials and believes that the use of these screens 
conflicts with court cases that have held that their use contravenes 
the Medicare statute. The commenter believes that this type of 
frequency screen is used as an absolute denial mechanisms or 
irrebuttable presumption that forecloses the opportunity for an 
individualized determination of medical necessity and is, therefore, 
illegal. The court decisions of Vorster v. Bowen, 709 F. Supp. 934 
(C.D.Cal. 1989); and Fox v. Bowen, 656 F. Supp. 1236 (D.C.Conn. 1987) 
are cited in support of the commenter's assertion.
    Response: We believe the commenter has misunderstood the March 10, 
2000 proposed rule with respect to Medicare policy on automatic denial 
of laboratory claims as the policy applies to frequency screens. This 
policy does not provide for automatic denials of laboratory claims 
based on frequency. Rather, under the proposed policy, contractors will 
provide frequency guidance before implementation of any frequency 
screens. Entities submitting claims for laboratory services that exceed 
the frequency guidance are encouraged to submit documentation of the 
medical necessity of the service with the claim. Contractors will 
review all documentation submitted before making a determination on the 
claim.
    We do not believe that this policy is in conflict with the court 
cases that the commenter has referenced. On the contrary, the Court in 
Vorster expressly determined that the Medicare statute and its 
legislative history supported the use of utilization screens by 
carriers in processing claims under Part B. In that case, the 
plaintiff, a Medicare beneficiary, submitted claims for covered 
chiropractic services to the carrier that were subsequently denied 
entirely, based on application of a utilization screen. The plaintiff 
then sought a review determination from the carrier and submitted 
additional information to the carrier in support of her claim. The 
carrier again denied the claims, and the beneficiary then filed suit, 
alleging that the use of utilization screens was a violation of the 
Medicare statute.

[[Page 58803]]

    The Court in Vorster rejected the plaintiff's allegation that the 
use of utilization screens violated the Medicare statute. According to 
the Court in that case: The Congress instructed the Secretary to use 
the expertise of private sector carriers in administering the Part B 
plan, and has acknowledged that the efficient administration of the 
Part B program includes review of utilization and the control of 
unnecessary utilization of covered services. [Citations omitted.]
* * * * *
    Based upon the foregoing legislative history, it appears that in 
general, the Congress would approve the use of utilization screens in 
processing claims. Vorster, 709 F. Supp. 940-41. The Court in Vorster 
noted that the use of utilization screens would contravene the Medicare 
statute if they were used as ``absolute denial mechanisms'' or as 
``irrefutable presumptions, which foreclosed any meaningful opportunity 
to receive an individualized determination of medical necessity.'' 
Vorster, 709 F. Supp. at 941. As we have stated above, however, the use 
of utilization screens as contemplated in the policy does not act as 
either an ``absolute denial mechanism'' or as an ``irrefutable 
presumption which foreclose[s] any meaningful opportunity to receive an 
individualized determination of medical necessity.''
    We also do not think that the reasoning in the Fox v. Bowen case, 
also cited by the commenter, is applicable to the proposed policy. The 
Fox case involved a challenge to a denial of claims for physical 
therapy services to skilled nursing facility patients. A fiscal 
intermediary in that case had established parameters for determining 
whether physical therapy services would be covered for patients in 
skilled nursing facilities. The Court characterized those parameters as 
``informal presumptions'' or ``rules of thumb,'' applied across the 
board ``without regard to the therapeutic requirements of the 
individual patient.'' Fox, 656 F. Supp. at 1248. The regulations 
promulgated by the Secretary, and the manual that was provided to 
assist intermediaries in making coverage determinations for physical 
therapy services, however, contemplated clearly that beneficiaries 
would receive an individualized assessment of need for physical therapy 
services. Id. Because an intermediary's practice in that case did not 
conform to the requirements of the regulations calling for an 
individual assessment of need for covered services, the Court in Fox 
determined that the practice was unlawful. We believe, therefore, that 
the Fox case is inapplicable to the proposed policy. The proposed 
policy does not constitute a denial of benefits based on ``informal 
presumptions'' or ``rules of thumb'' applied across the board without 
regard to the therapeutic requirements of the individual patient.
    Comment: One commenter expressed concern that there is little 
oversight of the LMRP development process, which often results in LMRPs 
being developed without regard to our coverage guidelines. The 
commenter indicated that, although the Medicare Carrier's Manual 
requires, and the March 10, 2000 proposed rule suggests that LMRPs must 
be based on medical literature and current clinical practice 
guidelines, many are not. The commenter also stated that because there 
is no public notice for the development of LMRPs, there is no 
opportunity for beneficiaries to comment on them, and only limited 
opportunity for affected practitioners to do so.
    Response: An LMRP is primarily a program integrity tool. It is 
developed to address identified or potential abuse, such as 
overutilization. In the absence of national policy, it is generally 
developed to specify criteria that describe whether the item or service 
is covered and under what clinical circumstances it is considered to be 
reasonable, necessary, and appropriate. The process for developing 
LMRPs includes the following: (1) Development of a draft policy based 
on review of medical literature and the contractor's understanding of 
local practice; (2) soliciting comments from the medical community, 
including the Contractor Advisory Committee (CAC); (3) responding to 
and incorporating into a final policy the comments received; and (4) 
notifying providers of the policy's effective date.
    In accordance with our instructions to contractors, LMRPs must be 
based on the strongest evidence available. The initial action in 
gathering evidence in developing an LMRP must always be a search of 
published scientific literature for any available evidence pertaining 
to the item or service in question. We instruct contractors to heavily 
weigh published authoritative evidence derived from randomized clinical 
trials or other definitive studies. We also instruct contractors to 
consider as evidence the consensus of expert medical opinion (that is, 
recognized authorities in the field) or medical opinion derived from 
consultation with medical associations or other health care experts. We 
do advise them, however, that acceptance by individual providers or 
groups of providers does not normally indicate general acceptance by 
the medical community. Testimonials and limited case studies 
distributed by sponsors with a financial interest in the outcome is not 
sufficient evidence of general acceptance by the medical community.
    Contractors are required to provide a minimum comment period of 45 
days on proposed LMRPs. The 45-day period begins with distribution to 
the CAC. Contractors are required to make their CAC meetings open to 
the public, and all interested parties, including beneficiaries, may 
attend and comment on the proposed policies. Further, the proposed 
policy is not only distributed to the CAC, but also to representatives 
of specialty societies, other than those represented on the CAC, when 
appropriate. Contractors are instructed to remain sensitive to other 
organizations or groups, which may have an interest in an issue. All 
comments received are considered and responded to either through the 
contractor's newsletter or individually to the commenter. The final 
policy is announced in a contractor bulletin at least 30 days before 
implementation.
    Our regional staffs review the contractors' performance annually. 
If the commenter has specific details regarding a contractor that is 
not following the above requirements in the development of its local 
policies, they should notify us so that it can be investigated.
    Comment: Three commenters expressed concern with limitations that 
might be imposed by the provision for automatic denial for egregious 
utilization.
    Response: After considering the comments, we believes that the 
March 10, 2000 proposed rule was not sufficiently detailed in respect 
to this provision to benefit from public comment. Consequently, we are 
withdrawing the provision of automatic denial for egregious utilization 
and will study the matter further.
    Comment: One commenter believes that the use of frequency screens 
that results in automatic denials will lead to underutilization of 
Medicare-covered medically necessary services by encouraging 
laboratories to give Advance Beneficiary Notices (ABNs) in every 
situation.
    Response: The commenter appears to have misunderstood the March 10, 
2000 proposed rule with regard to automatic denials. The proposed 
policy severely limits automatic denial based on frequency. The 
proposed policy, which we are incorporating in this final rule, 
provides that, except in limited and specified circumstances as 
described in

[[Page 58804]]

these regulations, we will not deny a claim for services that exceed 
utilization parameters without reviewing all relevant documentation 
submitted with the claim. For example, before denying a claim, 
contractors must review and consider justifications prepared by a 
provider or supplier, primary and secondary diagnosis, and copies of 
medical records that are submitted with the claim. Contractors may 
automatically deny a claim without any manual review only if a national 
coverage decision or LMRP specifies the circumstances under which a 
service is denied and those circumstances exist, or the service is 
specifically excluded from Medicare coverage by statute.
    We do not believe that application of a Medicare policy on 
automatic denial of laboratory claims, as described in these 
regulations, will result in the underutilization of Medicare covered 
services as the commenter suggested. To the extent that laboratories 
and physicians may issue additional ABNs to these patients that they 
would not do otherwise, we believe that this may, in fact, be helpful 
to beneficiaries. The purpose of the ABN is to give beneficiaries 
advance notice that a service may not be covered so that they have the 
opportunity to make an informed choice on whether to have the service 
or not.
    Comment: Four commenters offered suggestions for how the Medicare 
policy on Advance Beneficiary Notices (ABNs) should be clarified with 
respect to situations when laboratory tests that are performed exceed 
frequency limitations. They also made suggestions regarding when ABNs 
need to be signed by beneficiaries under the Medicare limitation on 
liability provisions.
    Response: As we indicated in the preamble to the March 10, 2000 
proposed rule, section IV, Other Topics Discussed by the Committee, the 
Medicare provisions on limitation on liability (sometimes called waiver 
of liability) were identified as falling outside the scope of the 
clinical laboratory negotiations. The limitation on liability 
provisions (including the related subject of ABNs) are currently found 
in section 1879 of the Act; 42 CFR part 411, subpart K; section 
7330.5.A of the Medicare Carriers Manual; sections 3440 through 3446.9 
of the Fiscal Intermediary Manual, and any currently applicable rules. 
Revised Part B ABNs, including one specifically relating to providers 
of clinical laboratory services, have been circulated in the Paperwork 
Reduction Act public comment process since October 26, 2000. All 
interested parties have had the opportunity to comment on those revised 
notices.
    Comment: One commenter believes that a laboratory should be 
required to track frequencies only for tests performed for 
beneficiaries by the clinical laboratory itself and requests that we 
confirm this in the final rule.
    Response: We do not place any requirements on laboratories to track 
frequencies of tests used by Medicare beneficiaries they serve, whether 
those services are furnished by a single laboratory or are performed by 
other laboratories.
    Comment: One commenter suggested that laboratories should be 
allowed to bill the patient for frequency denials regardless of whether 
an ABN has been issued to the beneficiary.
    Response: Under section 1879(a) and (b) of the Act, a provider of 
clinical laboratory services may bill a Medicare beneficiary for its 
services that are denied Medicare payment due to lack of medical 
necessity only if the laboratory informed the patient, before 
furnishing the service, that Medicare was likely to deny payment for 
the service. Frequency based denials are made because a contractor has 
determined that it is not reasonable and necessary for a beneficiary to 
receive that quantity of services based on the documentation that is 
presented with the claim. Therefore, the statute does not permit us to 
authorize laboratories to bill a beneficiary for the services that are 
denied based on frequency unless the beneficiary has been advised of 
the potential denial.
    Comment: One commenter asked why hospitals performing laboratory 
tests for outpatients are not allowed to ask their Medicare patients to 
sign ABNs in circumstances when Medicare coverage is uncertain due to 
medical necessity considerations.
    Response: Since the proposed rule was published on March 10, 2000, 
we have clarified our Medicare policy on the use of Part B ABNs by 
hospitals that perform laboratory tests and other Part B services. On 
July 27, 2000, we issued a Program Memorandum (PM) (PM A-00-43) to our 
Medicare contractors that explicitly provides for the use of the 
current Part B ABN in the institutional setting.
    Comment: One commenter noted that claims for laboratory services 
that exceed frequency limitations can only be read by the Medicare 
contractors if they are able to image attachments that come with the 
first claim submission. The commenter suggested that we make certain 
that all of our Medicare contractors image and review attachments 
submitted with initial claims.
    Response: All Medicare contractors have the capability to image 
hard copy documentation that is submitted with the claim. Unless the 
claim is suitable for auto-denial because the national of local policy 
specifies the circumstances under which the service is denied or the 
service is specifically excluded from Medicare coverage by law, 
contractors are required to review any such documentation before making 
a determination on the claim (See section 5.1 of the Program Integrity 
Manual.)
    Comment: One commenter suggested that when Medicare clinical 
laboratory test specimens are being referred to multiple laboratories, 
contractors should develop claims that exceed the frequency parameters 
before denial. Specifically, the commenter proposed the following 
three-step approach: (1) Use prepayment methods to scrutinize the 
laboratories involved, particularly those that have billing profiles 
known to be suspect; (2) directly contact the ordering physicians by 
mail, suggesting that they review the billing and medical necessity of 
the tests; and (3) encourage physicians to share laboratory reports 
among all physicians participating in the care of their respective 
patients.
    Response: In response to our specific request for new ideas on how 
to respond to the multiple laboratory problems discussed by the 
Committee and described in detail in the March 10, 2000 proposed rule, 
the commenter offered several interesting suggestions for doing this, 
but generally the suggestions are not new ones. As we indicated in the 
March 10, 2000 proposed rule, it would be very costly for our 
contractors to undertake the developmental work on clinical laboratory 
claims that would be required to use the prepayment methods proposed by 
the commenter. At present, laboratories and ordering physicians are 
free to submit medical justification that our contractors are required 
to consider. However, we cannot commit to the development of every 
claim before a denial based on excessive frequency in the fashion 
suggested by the commenter. We agreed to require contractors to publish 
frequency limitation guidance to laboratories and physicians in advance 
of their use as screens in the claims review process. We recognize that 
physicians and laboratories may not be aware of the number of times 
that a given beneficiary has had testing performed during a particular 
time period due to the use of multiple providers. We do, indeed, 
encourage physicians to share their patients' laboratory reports with 
other physicians participating in the care of their

[[Page 58805]]

patients, particularly those to whom they make referrals.
    Comment: Ten commenters responded to the Committee's request 
regarding informing beneficiaries of frequency denials by expressing 
concern that without a Medicare database available, clinical 
laboratories will be unable to identify patients who are reaching the 
frequency limitation and, thus, will be unable to inform patients of 
possible claims denials. Seven of the ten commenters suggested that 
Medicare provide timely access to the Common Working File (CWF) for 
monitoring frequencies. Two of the ten commenters suggested that any 
information-sharing system that relies upon mailing paper notices to 
beneficiaries to share with their physicians would be inefficient and 
administratively burdensome to Medicare as well as confusing to 
beneficiaries. They requested instead that Medicare develop a 
comprehensive database, ideally electronic, containing patient-specific 
laboratory test frequency information.
    Response: We cannot adopt any of the database proposals for several 
reasons. Several Committee members during the negotiations suggested 
similar proposals for notifying beneficiaries of frequency denials and 
requesting that they advise their physicians of the denials in an 
effort to encourage their physicians to obtain ABNs. We believed then, 
and continue to maintain, that it would not be possible for us to 
implement any of the notification proposals because of the high cost to 
Medicare. In addition, we believe that even the most sophisticated 
systems that might be available in the next few years would be likely 
to inaccurately identify potential denial situations due to time lags 
between receipt of services. Since the Committee could not agree to a 
specific proposal for dealing with the problem raised, we did agree to 
solicit in the March 10, 2000 proposed rule new ideas--especially ideas 
that included shared responsibility--for addressing this problem from 
Committee members as well as others. Unfortunately, the database 
proposals described above do not meet the parameters for shared 
responsibility that we were seeking, but instead would place a 
disproportionate responsibility and cost on the Medicare program.
    We will continue to consider ideas for assisting Medicare 
beneficiaries become aware of potential overutilization of clinical 
diagnostic laboratory testing while protecting the privacy of their 
medical information. If we discover a mechanism that ensures privacy 
protections, accurately reflects current proximity to frequency 
expectations, and is easy for beneficiaries to understand, we will 
implement the system expeditiously.
    Comment: One commenter suggested that the Explanation of Medicare 
Benefits (EOMB) should indicate to the beneficiary when a frequency 
limit has been exceeded. In this way, the beneficiary would know that 
future services for the same test may potentially be denied.
    Response: The Committee discussed a similar suggestion. We 
expressed concern that the proposal would be costly to implement with 
little assurances that it would be beneficial. Several members of the 
Committee acknowledged that beneficiaries are not likely to remember 
the specific tests for which they have received frequency notification 
nor are they likely to take their EOMB with them when they visit their 
physician. Thus, we believe we are not likely that notification of 
beneficiaries in the EOMB would be helpful.
    Moreover, frequency screens are applied over a period of time. For 
example, a contractor may set a frequency screen of four glycated 
hemoglobin tests per year. However, neither the beneficiary nor the 
physician is likely to know when the base period is reset, making the 
notification no longer applicable. Thus, it is possible that armed with 
incomplete or outdated information, a beneficiary may not be offered a 
medically necessary test or may decline a medically necessary test 
because he/she believes the test would not be covered. Consequently, we 
are not adopting this suggestion because we believe it not only would 
not be cost-effective, but it has a high risk of having harmful effects 
on Medicare beneficiaries.

Effective Date

    Comment: Several physicians who commented expressed concern with 
the 12-month delay in effective date proposed in the March 10, 2000 
proposed rule. They were particularly interested in earlier 
implementation of the coverage policies. The commenters urged us to 
consider earlier implementation, but they did not address the ability 
of the industry to implement the system changes associated with these 
policies or the impact of denials upon laboratories if physicians who 
have not been educated to the policies, order tests for conditions that 
are not presumed to be reasonable and necessary without submitting 
medical justification.
    Response: The Committee recommended a 12-month delay in the 
effective date of the rule for several reasons. First, the Committee 
was concerned that some of the policies involved changes in the 
computer systems of the entity they represented. The Committee noted 
that it is not possible for most laboratory, hospital, and physician 
office computer systems to be modified to accommodate changes quickly. 
It would not be possible for the industry to be prepared for 
implementation with only 90 days notice. Second, the Committee noted 
that a large volume of laboratory claims (approximately 60 percent) is 
potentially affected by the national coverage decisions.
    The Committee expressed concern that implementation of the policies 
without an adequate prior period of education of the physician and 
laboratory community could result in a significant volume of denied 
claims without an opportunity to recover payment from beneficiaries. 
The Committee voluntarily planned an ambitious educational program and 
expressed a desire that the policies provide an adequate opportunity to 
engage those educational activities before implementation. 
Consequently, the Committee proposed a 12-month delay in effective 
date.
    We believed then, and continue to believe, that the concerns 
expressed by the many members of the negotiating Committee related to 
education and system changes are valid and that the delayed effective 
date of policies that require system changes or educational efforts is 
necessary and appropriate. Therefore, we are not accepting the 
commenters' suggestion to move up implementation of the NCDs for 
laboratory services.
    However, we note that a number of provisions that are discussed in 
the preamble to the March 10, 2000 proposed rule are not likely to 
require changes to computer systems nor is their implementation likely 
to result in a significant volume of claims denials if they are 
implemented without an extended period of prior notice.
    Instead, they entail clarification of our policies with regard to 
processing claims for clinical laboratory tests. For example, we agreed 
to issue instructions requiring contractors to provide frequency 
guidance before use of frequency screens, clarify that we do not 
require a signature to be submitted with claims, and clarify coding 
guidelines for reporting multiple procedures, etc. These provisions are 
essentially clarifications of our existing policies and issuing the 
clarifications sooner as opposed to later will significantly improve 
the working relationship

[[Page 58806]]

between some laboratories and Medicare claims processing contractors. 
In addition, issuance of these clarifications will restore confidence 
to laboratories who may have in the past acted in accordance with these 
policies but, because there has been lack of consistency in the 
interpretations, are fearful that they will later be advised that the 
claims are in error and subject to recovery of payment. Moreover, early 
implementation of these clarifications will result in more rapid 
consistency among the Medicare contractors in application of our 
administrative policies for laboratories, which is one of the primary 
objectives of the legislation (section 4554(b) of BBA) authorizing this 
rule. Finally, we believe that some of the provisions, such as 
requiring notice of utilization guidelines before implementation of 
frequency screens, hold universal benefit to the laboratory industry 
that should be available as soon as possible.
    We do not believe that earlier implementation of these 
clarifications will adversely affect laboratories. Therefore, 
provisions of the rule that are not likely to require system changes or 
result in a significant volume of claims denials if implemented without 
an extended period of education, will be effective February 21, 2002, 
and we will issue the program instructions within 90 days of 
publication of the final rule. We believe that this includes the 
following provisions related to:
     Clarification that the administrative policies discussed 
in the preamble to the March 10, 2000 proposed rule and the NCDs in the 
addendum to the March 10, 2000 proposed rule apply equally to all 
clinical diagnostic laboratory tests payable under Part B regardless of 
setting (hospital and nonhospital). (See preamble section III and 
Sec. 410.28 and 410.32 of this final rule.)
     Clarification that use of the term ``screening'' or 
``screen'' in a CPT code descriptor does not necessarily describe a 
test performed in the absence of signs or symptoms of illness, disease 
or condition. (See preamble section III.C.1.)
     Clarification of the use of modifier codes to indicate 
multiple services that are medically necessary to diagnose or treat the 
beneficiary's condition. (See section III.C.2. of the preamble.)
     Clarification that the signature of the ordering physician 
is not required for Medicare purposes on a laboratory test requisition. 
(See section III.D.3 of the preamble.)
     Clarification that appropriate diagnosis codes may be 
assigned to a narrative, even if wording of the narrative does not 
exactly match the code descriptor for the ICD-9-CM code. (See section 
III.E.1 of the preamble.)
     Clarification that laboratories may use the narrative 
field on the claims to report additional diagnoses if the Medicare 
contractor's system will not accept all of the codes in the diagnoses 
field. (See section III.E.2 of the preamble.)
     Clarification that in the absence of matching diagnosis to 
procedure codes supplied by the laboratory, Medicare contractors will 
examine all submitted codes on prepayment review, taking into account 
program integrity. (See section III.E.3 of the preamble.)
     Clarification that Medicare contractors will not use a 
frequency screen that could result in a frequency-based denial unless 
the contractor has published information about the appropriate 
frequency for the service or unless we have published information about 
the appropriate frequency in a national coverage decision. (See section 
III.F.1 of the preamble.)
     Codification of the existing policy that Medicare will not 
deny a claim for services that exceed utilization parameters without 
reviewing all relevant documentation submitted with the claim. (See 
section III.F.2 of the preamble and Sec. 410.32(d)(4) contained in this 
final rule.) Remaining provision of the rule, which are primarily 
provisions that are likely to involve system changes and require 
educational efforts to avoid erroneous denial of claims, will become 
effective November 25, 2002. These provisions include:
     Date of service (section III.A.3 of the preamble).
     Use of consistent remittance message (section III.F.4 of 
the preamble.
     National coverage decisions (addendum).
     Maintenance and submission of documentation (section 
III.D.1 and 2 of the preamble and Sec. 410.32(d)(2) and (d)(3)).
    The effective dates for changes made to the CFR as described in 
this rule are as follows:
     Sections 410.28 (f) and section 410.32(e), which provide 
for equal application of the rules relating to laboratory service to 
hospital and CAHs, are effective February 21, 2002.
     The redesignation of paragraphs in Sec. 410.32(d) is 
effective February 21, 2002.
     Section 410.32(d)(2) and (d)(3), which specifies 
documentation and recordkeeping requirements and claims review 
procedures, are effective November 25, 2002.
     Section 410.32(d)(4), which provides for review of 
information submitted with a claim before denial for utilization 
parameters unless a national of local policy on the service exists, is 
effective February 21, 2002.

IV. Summary of Changes to the Proposed Rule

    The proposed rule stated that the policies would be applicable to 
all laboratory tests ``billed under Medicare Part B, regardless of the 
location * * * (Physicians' office laboratories, hospital laboratories, 
independent laboratories, etc., or of the type of Medicare contractor 
processing the claims (carriers or fiscal intermediaries).'' 65 FR 
13084. In order to make the policies applicable to all settings, 
Centers for Medicare & Medicaid Services is revising Sec. 410.28 and 
Sec. 410.32 to clarify the applicability of the provisions of this rule 
to hospitals and CAHs providing tests covered under Part B to 
outpatients.
    1. We are adding the following codes to the list of codes covered 
by Medicare in the various policies:

Blood glucose: 780.31, 781.0, 783.6
Digoxin: 429.2, 972.0
Fecal Occult Blood Test: 003.0, 003.1, 095.2, 095.3, 098.0, 098.7, 
098.84, 139.8, 159.0-159.9, 569.82, 569.83, 596.1, 751.1
Gamma Glutamyl Transferase: 230.7, 230.9, 642.5, 782.4, 789.1, 790.4, 
790.5, V42.7
Lipids: 278.00, 401.0-401.9, 402.00-402.91, 403.00-403.91, 404.00-
404.93, 405.01-405.99, V42.7
Prostate Specific Antigen: 236.5, 599.6, 788.30, 788.41, 788.43, 788.62
Human immunodeficiency virus testing (Diagnosis): 263.0, 263.1, 263.9, 
486
Partial thromboplastin time: 362.30, 362.31, 362.32, 362.33, 362.34, 
362.35, 362.36, 362.37, 410.0-.9, 456.8, 530.82,
Prothrombin time: 786.50, V12.51-V12.59
Iron Studies: 579.8, 579.9, 713.0, 716.4-716.9, V56.0, V56.8
Thyroid: 290.3, 297.1, 333.99, 358.1, 359.5, 376.21, 376.22, 425.7

    2. We are removing the paragraph regarding denial of claims for 
services using devices that require, but do not have, FDA approval from 
the reasons for denial section of all 23 policies. Under the national 
coverage decision regarding clinical trials, certain items that require 
but do not have FDA approval may be covered.
    3. We are amending the NCD on collagen crosslinks by adding a 
clarification that both men and women may receive the test. We are also 
deleting codes 203.00 and 203.01 from the list of ICD-9-CM codes that 
are covered by Medicare, as this diagnosis is not included in the 
indication section of the policy.

[[Page 58807]]

    4. We are modifying the policy for Gonodotropin, chorionic (HCG); 
quantitative to clarify that the test is not useful for diagnosing 
pregnancy.
    5. We are deleting the language proposed for inclusion in 
Sec. 410.32(d)(4) on automatic denial and manual review that relates to 
egregious overutilization.
    6. We are changing the effective date for certain provisions of the 
rule from that proposed. The following provisions are effective 
February 21, 2002, and we will issue the program instructions within 90 
days of publication of the final rule. We believe that this includes 
the provisions related to the following:
     Clarification that laboratory policies apply equally to 
all laboratories (hospital and nonhospital) as contained in section III 
of the proposed rule, and Secs. 410.28(f) and 410.32(e) of this final 
rule.
     Clarification of codes that use the word ``screening'' in 
the descriptor as contained in section III.C.1 of the proposed rule.
     Clarification of coding of multiple tests as contained in 
section III.C.2 of the proposed rule.
     Clarification the signature is not required on requisition 
as contained in section III.D.3 of the proposed rule.
     Clarification of coding narrative diagnoses as contained 
in section III.E.1 of the proposed rule,
     Clarification on the number of diagnoses on a claim as 
contained in section III.E.2 of the proposed rule.
     Clarification on diagnosis and procedure code matching as 
contained in section III.E.3 of the proposed rule.
     Publishing frequency guidance before implementing screens 
as contained in section III.F.1 of the proposed rule.
     Reminder of auto denial policies as contained in section 
III.F.2 of the proposed rule, and Sec. 410.32(d)(4).
     Consistency in remittance messages as contained in section 
III.F.4. of the proposed rule.
    Provisions that will become effective November 25, 2002 include the 
following:
     Date of service as described in section III.A.3. of the 
proposed rule.
     Use of consistent remittance message as described in 
section III.F.4 of the preamble.
     National coverage decisions as described in the addendum.
     Requesting documentation directly from ordering 
practitioner as described in section III.D.2 of the proposed rule and 
Secs. 410.32(d)(2) and (d)(3) of this final rule.

V. 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(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.

Documentation and Recordkeeping Requirements

    In summary, Sec. 410.32(d)(2)(i) requires the physician or 
(qualified nonphysican practitioner, as defined in paragraph (a)(3) of 
this section), who orders the service to maintain documentation of 
medical necessity in the beneficiary's medical record.
    While this requirement is subject to the PRA, we believe that the 
burden associated with this requirement is exempt from the PRA, as 
defined in 5 CFR 1320.3(b)(2), because this requirement is considered a 
usual and customary business practice.

Submitting the Claim

    In summary, Sec. 410.32(d)(2)(ii) requires an entity submitting the 
claim to maintain the following documentation:
     The documentation that it receives from the ordering 
physician.
     The documentation that the information that it submitted 
with the claim accurately reflects the information it received from the 
ordering physician.
    While this requirement is subject to the PRA, we believe that the 
burden associated with this requirement is exempt from the PRA, as 
defined in 5 CFR 1320.3(b)(2), because this requirement is considered a 
usual and customary business practice.

Entity Request for Additional Information

    In summary, Sec. 410.32(d)(2)(iii) requires that an entity 
submitting a claim may request additional diagnostic and other 
information to document that the services it bills are reasonable and 
necessary. If the entity requests additional documentation, it must 
request material relevant to the medical necessity of the specific 
test(s), taking into consideration current rules and regulations on 
patient confidentiality.
    The burden associated with this requirement is the time and effort 
for the physician or qualified nonphysican practitioner, as defined in 
paragraph (a)(3) of this section, who orders the service, to disclose 
additional diagnostic and other information to the entity submitting 
the claim that demonstrates that the services it bills are reasonable 
and necessary. While this requirement is subject to the PRA, we believe 
that the burden associated with this requirement is exempt from the 
PRA, as defined in 5 CFR 1320.3(b)(2), because this requirement is 
considered a usual and customary business practice.

Claims Review: Documentation Requirements

    In summary, Sec. 410.32(d)(3)(i) requires that an entity submitting 
a claim provide to Centers for Medicare & Medicaid Services upon 
request; (1) documentation of the physician's order for the service 
billed (including information sufficient to enable Centers for Medicare 
& Medicaid Services to identify and contact the ordering physician), 
(2) documentation showing accurate processing of the order and 
submission of the claim, and (3) any diagnostic or other medical 
information supplied to the laboratory by the ordering physician, 
including any ICD-9-CM code or narrative description supplied.
    In summary, Sec. 410.32(d)(3)(iii) authorizes the entity submitting 
the claim to request additional diagnostic and other medical 
information that is relevant to the medical necessity of the specific 
services from the ordering physician consistent with applicable patient 
confidentiality laws and regulations.
    Since these reporting requirements would be imposed under the 
conduct of an administrative action and/or audit, these requirements 
are not subject to the PRA as defined under 5 CFR 1320.4(a)(2).
    If you have any comments on any of these information collection and 
recordkeeping requirements, please mail the original and three copies 
directly to the following:
    Centers for Medicare & Medicaid Services, Office of Information 
Services, Standards and Security Group, Division of Enterprise 
Standards, Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850l. Attn: John Burke 3250-F; and Office of Information and

[[Page 58808]]

Regulatory Affairs, Office of Management and Budget, Room 10235, New 
Executive Office Building, Washington, DC 20503, Attn: Allison Eydt, 
Desk Officer.

VI. Regulatory Impact Analysis

    We have examined the impacts of this final rule as required by 
Executive Order (EO) 12866, the Unfunded Mandates Reform Act of 1995, 
and the Regulatory Flexibility Act (RFA) (Public Law 96-354). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when 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).
    Section 1102(b) of the Social Security Act (the Act) requires us to 
prepare a regulatory impact analysis (RIA) 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 of 
a Metropolitan Statistical Area and has fewer than 100 beds.

A. Executive Order 12866

    The intent of this final rule is to promote program integrity and 
national uniformity and simplify administrative procedures for clinical 
diagnostic laboratory services. We do not expect the provisions of this 
final rule to have a significant cost effect upon providers or 
suppliers. The provisions of the final rule, for the most part, are 
administrative and state explicitly and codify practices that are 
currently in effect. That is, physicians maintain documentation in the 
medical record and laboratories maintain the information that is 
provided to them. We expect no cost consequence of codifying this 
common practice.
    Similarly, we do not anticipate a cost effect of the provision 
related to the documentation that must be submitted upon claims review. 
While some Medicare contractors presently request medical record 
information directly from laboratories, the laboratories must in turn 
seek the information from the physicians. Requiring Medicare 
contractors to seek medical record information directly from physicians 
may result in a minimal increase in the administrative cost of 
conducting claims review. We anticipate that there would be offsetting 
savings from reduced Medicare contractor requests to laboratories for 
documentation. This would result in a decreased documentation burden to 
the laboratories.
    The provision in Sec. 410.32(d)(4) merely codifies policies that 
are presently included in the Medicare program manuals. Since these 
provisions are currently operational, there is no cost effect to their 
codification. The national coverage decisions published as Addendum B 
to this final rule potentially may give rise to a cost effect. 
Approximately 60 percent of the total volume of laboratory claims would 
be subject to a national coverage decision. Implementation of the 
national coverage decisions would result in some adjustments in the 
amount and degree of coverage (that is, there would be some increases 
and some decreases). However, we do not have data available to 
precisely quantify the amounts involved. We estimate that the net cost 
effect of these coverage decisions would not be significant.
    If there is currently an LMRP for a test for which we issue a 
national coverage decision, and the LMRP was more liberal than the 
national coverage decisions, this will result in cost savings to the 
Medicare program. If an LMRP was more restrictive than a national 
coverage decision, it will result in a cost increase for the Medicare 
program. After careful analysis of the information available regarding 
LMRPs, we estimate that the costs and savings are likely to offset each 
other, and that the national coverage decisions will have a negligible 
cost impact.
    We should point out, however, that clinical diagnostic laboratory 
services are considered as part of the calculation of the sustained 
growth factor used in determining changes in the Medicare payment 
amounts under the Medicare physician fee schedule. Should there be a 
significant increase in Medicare payment for laboratory services, 
Medicare may recover these costs through reductions in the otherwise 
applicable physician payments.

B. The Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 also requires (in section 
202) that agencies prepare an assessment of anticipated costs and 
benefits before proposing any rule that may result in an expenditure in 
any one year by State, local, or tribal governments, in the aggregate, 
or by the private sector, of $110 million. As noted above, we do not 
anticipate that this final rule will have a significant cost impact. 
Thus, we certify that this final rule will not result in expenditure in 
any one year by State, local, or tribal governments, in the aggregate, 
or by the private sector of $110 million.

C. Regulatory Flexibility Act (RFA)

    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 governmental agencies. 
Most hospitals and most other providers and suppliers are small 
entities, either by nonprofit status or by having revenues of $5 
million to $25 million or less annually (see 65 FR 69432). 
Intermediaries and carriers, physicians, and many laboratories are 
considered small entities.
    This final rule will affect all clinical laboratories located in 
physician offices, hospitals, other health facilities, Medicare 
contractors, and independent laboratories. There are approximately 
160,000 labs affected. We believe the impact of this final rule on 
these entities, for the most part, will be positive.
    As stated above, this final rule will, for the most part, 
explicitly state and codify existing policies. Having a clear statement 
of policies will be beneficial to entities submitting Medicare claims 
because they can avoid unintentional errors. The provision relating to 
Medicare seeking medical record information directly from physicians 
will reduce the burden of recordkeeping and reporting on laboratories 
without increasing the burden on physicians. Publication of clear and 
consistent national coverage decisions will assist physicians and 
laboratories in knowing in advance situations in which additional 
documentation may be needed to support payment on a claim. The 
documentation may be submitted with the initial claim, thus avoiding 
the increased cost of appealing a denied claim. National coverage 
decisions relating to laboratory claims will result in consistent 
coverage determination regardless of geography, and, consequently, less 
confusion for beneficiaries, who often do not understand the present 
situations of coverage for a service in one area and not in other 
areas. Reduced confusion for the beneficiary results in reduced inquiry 
workloads for Medicare contractors.
    As noted above, there may be some areas where implementation of the 
national coverage decisions will result in denial of payment in 
situations in which payment is presently made. We

[[Page 58809]]

believe that the policies, developed in partnership with the physician 
and laboratory community and based on authoritative evidence, reflect 
the appropriate treatment of clinical diagnostic laboratory services. 
Thus, to the extent that payment is presently being made for these 
services, we believe it is inappropriate and should be curtailed.
    We do not expect any beneficiary to be deprived of medically 
necessary services as a result of these provisions. Nor do we expect 
that there will be an impact upon the availability of covered services 
to beneficiaries. Beneficiaries may, however, experience a minimal 
increase in out-of-pocket costs if they choose to have testing that is 
not covered by Medicare. That is, publication of clear decisions 
regarding when a test is considered medically necessary may prompt 
physicians and laboratories to execute advanced beneficiary notices and 
charge patients for noncovered services, when they may not have 
followed these procedures due to ambiguity regarding whether the 
service will be covered by Medicare.
    For these reasons, the Secretary certifies that this rule will not 
have a significant economic impact on a substantial number of small 
entities or a significant impact on the operations of a substantial 
number of small rural hospitals.
    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget reviewed this regulation.
    We have reviewed this rule under the threshold criteria of 
Executive Order 13132. We have determined that it does not 
significantly affect States' rights, roles, and responsibilities.

List of Subjects in 42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Rural areas, X-rays.

    For the reasons set forth in the preamble the Centers for Medicare 
& Medicaid Services amends, 42 CFR chapter IV as follows:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

Subpart B--Medical and Other Health Services

    1. The authority citation for part 410 continues to read as 
follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

    2. A new paragraph (f) is added to Sec. 410.28 to read as follows:


Sec. 410.28  Hospital or CAH diagnostic services furnished to 
outpatients: Conditions.

* * * * *
    (f) The rules for clinical diagnostic laboratory tests set forth in 
Secs. 410.32(a) and (d)(2) through (d)(4) of this subpart are 
applicable to those tests when furnished in hospitals and CAHs.

    3. In Sec. 410.32:
    A. Paragraphs (d)(1) through (d)(7) are redesignated as paragraphs 
(d)(1)(i) through (d)(1)(vii);
    B. Paragraph (d) introductory text is redesignated as paragraph 
(d)(1) introductory text, and a heading is added; and
    C. Paragraphs (d)(2) through (e) are added to read as follows:


Sec. 410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests: Conditions.

* * * * *
    (d) Diagnostic laboratory tests. (1) Who may furnish services. * * 
*
    (2) Documentation and recordkeeping requirements.
    (i) Ordering the service. The physician or (qualified nonphysican 
practitioner, as defined in paragraph (a)(3) of this section), who 
orders the service must maintain documentation of medical necessity in 
the beneficiary's medical record.
    (ii) Submitting the claim. The entity submitting the claim must 
maintain the following documentation:
    (A) The documentation that it receives from the ordering physician 
or nonphysician practitioner.
    (B) The documentation that the information that it submitted with 
the claim accurately reflects the information it received from the 
ordering physician or nonphysician practitioner.
    (iii) Requesting additional information. The entity submitting the 
claim may request additional diagnostic and other medical information 
to document that the services it bills are reasonable and necessary. If 
the entity requests additional documentation, it must request material 
relevant to the medical necessity of the specific test(s), taking into 
consideration current rules and regulations on patient confidentiality.
    (3) Claims review. (i) Documentation requirements. Upon request by 
CMS, the entity submitting the claim must provide the following 
information:
    (A) Documentation of the order for the service billed (including 
information sufficient to enable CMS to identify and contact the 
ordering physician or nonphysician practitioner).
    (B) Documentation showing accurate processing of the order and 
submission of the claim.
    (C) Diagnostic or other medical information supplied to the 
laboratory by the ordering physician or nonphysician practitioner, 
including any ICD-9-CM code or narrative description supplied.
    (ii) Services that are not reasonable and necessary. If the 
documentation provided under paragraph (d)(3)(i) of this section does 
not demonstrate that the service is reasonable and necessary, CMS takes 
the following actions:
    (A) Provides the ordering physician or nonphysician practitioner 
information sufficient to identify the claim being reviewed.
    (B) Requests from the ordering physician or nonphysician 
practitioner those parts of a beneficiary's medical record that are 
relevant to the specific claim(s) being reviewed.
    (C) If the ordering physician or nonphysician practitioner does not 
supply the documentation requested, informs the entity submitting the 
claim(s) that the documentation has not been supplied and denies the 
claim.
    (iii) Medical necessity. The entity submitting the claim may 
request additional diagnostic and other medical information from the 
ordering physician or nonphysician practitioner to document that the 
services it bills are reasonable and necessary. If the entity requests 
additional documentation, it must request material relevant to the 
medical necessity of the specific test(s), taking into consideration 
current rules and regulations on patient confidentiality.
    (4) Automatic denial and manual review. (i) General rule. Except as 
provided in paragraph (d)(4)(ii) of this section, CMS does not deny a 
claim for services that exceed utilization parameters without reviewing 
all relevant documentation that is submitted with the claim (for 
example, justifications prepared by providers, primary and secondary 
diagnoses, and copies of medical records).
    (ii) Exceptions. CMS may automatically deny a claim without manual 
review if a national coverage decision or LMRP specifies the 
circumstances under which the service is denied, or the service is 
specifically excluded from Medicare coverage by law.
    (e) Diagnostic laboratory tests furnished in hospitals and CAHs. 
The provisions of paragraphs (a) and (d)(2) through (d)(4), inclusive, 
of this section apply to all diagnostic laboratory test furnished by 
hospitals and CAHs to outpatients.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital

[[Page 58810]]

Insurance; and Program No. 93.774, Medicare--Supplementary Medical 
Insurance Program)

    Dated: July 11, 2001.
Thomas A. Scully,
Administrator, Health Care Financing Administration.

    Dated: October 9, 2001.
Tommy G. Thompson,
Secretary.

Addendum A--Introduction to National Coverage Policies for 
Diagnostic Laboratory Tests

Purpose

    This addendum provides an introduction to national coverage 
policies for diagnostic laboratory tests payable under Part B of 
Medicare. This addendum explains what a national coverage policy is, 
what effect a national coverage policy has, and describes the various 
sections in the policies. In addition, it explains the two approaches 
used to develop these national coverage policies.

What Is a National Coverage Policy?

    Part B of title XVIII of the Social Security Act (the Act) provides 
for Supplementary Medical Insurance (SMI) for certain Medicare 
beneficiaries, specifying what health care items or services will be 
covered by the Medicare Part B program. Diagnostic laboratory tests are 
generally covered under Part B, unless excluded from coverage by the 
Act. Services that are generally excluded from coverage include routine 
physical examinations and services that are not reasonable and 
necessary for the diagnosis or treatment of an illness or injury. CMS 
interprets these provisions to prohibit coverage of screening services, 
including laboratory tests furnished in the absence of signs, symptoms, 
or personal history of disease or injury, except as explicitly 
authorized by statute. A test may be considered medically appropriate, 
but nonetheless be excluded from Medicare coverage by statute.
    A national coverage policy for diagnostic laboratory test(s) is a 
document stating CMS's policy with respect to the circumstances under 
which the test(s) will be considered reasonable and necessary, and not 
screening, for Medicare purposes. Such a policy applies nationwide. A 
national coverage policy is neither a practice parameter nor a 
statement of the accepted standard of medical practice. Words such as 
``may be indicated'' or ``may be considered medically necessary'' are 
used for this reason. Where a policy gives a general description and 
then lists examples (following words like ``for example'' or 
``including''), the list of examples is not meant to be all-inclusive 
but merely to provide some guidance.

What Is the Effect of a National Coverage Policy?

    A national coverage policy to which this introduction applies is a 
National Coverage Decision (NCD) under section 1862(a)(1) of the Social 
Security Act. Regulations on National Coverage Decisions are codified 
at 42 CFR 405.732(b)-(d). A Medicare contractor may not develop a local 
policy that conflicts with a national coverage policy.

What Is the Format for These National Coverage Policies?

    Below are the headings for national coverage policies, developed by 
the Negotiated Rulemaking Committee on Clinical Diagnostic Laboratory 
Tests.

Medicare National Coverage Decision

    This section identifies the official title of the policy.

Other Names/Abbreviations

    This section identifies other names for the policy. It generally 
reflects more colloquial terminology.

Description

    This section includes a description of the test(s) addressed by the 
policy and provides a general description of the appropriate uses of 
the test(s).

HCPCS Codes

    The descriptor(s) used in this section is (are) the Current 
Procedural Terminology (CPT) or other CMS Common Procedure Coding 
System (HCPCS). The CPT is developed and copyrighted by the American 
Medical Association (AMA). If a descriptor does not accurately or fully 
describe the test, a more complete description may be included 
elsewhere in the policy, such as in the Indications section.

Indications

    This section lists detailed clinical indications for Medicare 
coverage of the test(s).

Limitations

    This section lists any national frequency expectations, as well as 
other limitations on Medicare coverage of the specific test(s) 
addressed in the policy--for example, if it would be unnecessary to 
perform a particular test with a particular combination of diagnoses.

ICD-9-CM Codes Covered by Medicare Program

    This section includes covered codes--those where there is a 
presumption of medical necessity, but the claim is subject to review to 
determine whether the test was in fact reasonable and necessary. The 
diagnosis codes are from the International Classification of Diseases, 
Ninth Revision, Clinical Modification (ICD-9-CM). Where the policy 
takes an ``exclusionary'' approach, as described below, this section 
states: ``Any ICD-9-CM code not listed in either of the ICD-9-CM code 
sections below.''

Reasons for Denial

    This section includes standard language reflecting national policy 
with respect to all tests-- such as denial of screening services and 
denial if medical necessity is not documented in the patient's medical 
record. This section may also include reasons for denial related to the 
specific test(s). This section was not negotiated by the Negotiated 
Rulemaking Committee, but rather reflects CMS policy.

ICD-9-CM Codes Denied

    This section lists codes that are never covered. If a code from 
this section is given as the reason for the test, the test may be 
billed to the Medicare beneficiary without billing Medicare first 
because the service is not covered by statute, in most instances 
because it is performed for screening purposes and is not within an 
exception. The beneficiary, however, does have a right to have the 
claim submitted to Medicare, upon request.

ICD-9-CM Codes That Do Not Support Medical Necessity

    This section lists/describes generally non-covered codes for which 
there are only limited exceptions. However, additional documentation 
could support a determination of medical necessity in certain 
circumstances. Subject to section 1879 of the Social Security Act (the 
Act), 42 CFR 411, subpart K, section 7330 of the Medicare Carriers 
Manual section 3440-3446.9 of the Medicare Fiscal Intermediary Manual 
and any applicable rulings, it would be appropriate for the ordering 
physician or the laboratory to obtain an advance beneficiary notice 
from the beneficiary. Where the policy takes an ``inclusionary'' 
approach, as described below, this section states: ``Any ICD-9-CM code 
not listed in either of the ICD-9-CM sections above.''

[[Page 58811]]

Sources of Information

    Relevant sources of information used in developing the policy are 
listed in this section.

Coding Guidelines

    This section includes coding guidelines that apply generally to all 
policies, as well any additional coding instructions appropriate for a 
specific national coverage policy. The coding guidelines may be from or 
based on a Coding Clinic for ICD-9-CM published by the American 
Hospital Association.

Documentation Requirements

    This section refers to documentation requirements for clinical 
diagnostic laboratory tests at 42 CFR 410.32(d) and includes any 
specific documentation requirements related to the test(s) addressed in 
the policy.

Other Comments

    This section may contain any other relevant comments that are not 
addressed in the sections described above.

What Are the Two Approaches Used in Developing a National Coverage 
Policy?

    To develop national coverage policies for the tests assigned to 
each Workgroup, the Committee agreed to use one of two approaches, 
referred to as ``inclusionary'' and ``exclusionary''. Policies using 
the ``inclusionary'' approach list the ICD-9-CM codes in the following 
two categories: ICD-9-CM Codes Covered by Medicare Program and ICD-9-CM 
Codes Denied. These policies do not list the codes that require 
additional documentation to support medical necessity.
    The exclusionary approach was used for tests for which local 
medical review policies had identified a large number of acceptable 
ICD-9-CM codes. The Committee used this approach to develop a proposed 
policy on blood counts. In lieu of listing all the ICD-9-CM codes that 
support medical necessity of a test or group of tests, policies using 
the ``exclusionary'' approach list ICD-9-CM codes in the following two 
categories: ICD-9-CM Codes Denied and ICD-9-CM Codes That Do Not 
Support Medical Necessity.

Addendum B--National Coverage Decisions

Medicare National Coverage Decision: Culture, Bacterial, Urine
Other Names/Abbreviations: Urine culture

Description

    A bacterial urine culture is a laboratory procedure performed on a 
urine specimen to establish the probable etiology of a presumed urinary 
tract infection. It is common practice to do a urinalysis prior to a 
urine culture. A urine culture may also be used as part of the 
evaluation and management of another related condition. The procedure 
includes aerobic agar-based isolation of bacteria or other cultivable 
organisms present, and quantitation of types present based on 
morphologic criteria. Isolates deemed significant may be subjected to 
additional identification and susceptibility procedures as requested by 
the ordering physician. The physician's request may be through clearly 
documented and communicated laboratory protocols.

HCPCS Codes (alpha numeric, CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
87086.......................................  Culture, bacterial, urine; quantitative, colony count
87087.......................................  Culture, bacterial, urine; commercial kit
87088.......................................  Culture, bacterial, urine; identification, in addition to
                                               quantitative or commercial kit
87184.......................................  Sensitivity studies, antibiotic; disk method, per plate (12 or
                                               fewer disks)
87186.......................................  Sensitivity studies, antibiotic; microtiter, minimum inhibitory
                                               concentration (MIC), any number of antibiotics
----------------------------------------------------------------------------------------------------------------

Indications

    1. A patient's urinalysis is abnormal suggesting urinary tract 
infection, for example, abnormal microscopic (hematuria, pyuria, 
bacteriuria); abnormal biochemical urinalysis (positive leukocyte 
esterase, nitrite, protein, blood); a Gram's stain positive for 
microorganisms; positive bacteriuria screen by a non-culture technique; 
or other significant abnormality of a urinalysis. While it is not 
essential to evaluate a urine specimen by one of these methods before a 
urine culture is performed, certain clinical presentations with highly 
suggestive signs and symptoms may lend themselves to an antecedent 
urinalysis procedure where follow-up culture depends upon an initial 
positive or abnormal test result.
    2. A patient has clinical signs and symptoms indicative of a 
possible urinary tract infection (UTI). Acute lower UTI may present 
with urgency, frequency, nocturia, dysuria, discharge or incontinence. 
These findings may also be noted in upper UTI with additional systemic 
symptoms (for example, fever, chills, lethargy); or pain in the 
costovertebral, abdominal, or pelvic areas. Signs and symptoms may 
overlap considerably with other inflammatory conditions of the 
genitourinary tract (for example, prostatitis, urethritis, vaginitis, 
or cervicitis). Elderly or immunocompromised patients, or patients with 
neurologic disorders may present atypically (for example, general 
debility, acute mental status changes, declining functional status).
    3. The patient is being evaluated for suspected urosepsis, fever of 
unknown origin, or other systemic manifestations of infection but 
without a known source. Signs and symptoms used to define sepsis have 
been well-established.
    4. A test-of cure is generally not indicated in an uncomplicated 
infection. However, it may be indicated if the patient is being 
evaluated for response to therapy and there is a complicating co-
existing urinary abnormality including structural or functional 
abnormalities, calculi, foreign bodies, or ureteral/renal stents or 
there is clinical or laboratory evidence of failure to respond as 
described in Indications 1 and 2.
    5. In surgical procedures involving major manipulations of the 
genitourinary tract, preoperative examination to detect occult 
infection may be indicated in selected cases (for example, prior to 
renal transplantation, manipulation or removal of kidney stones, or 
transurethral surgery of the bladder or prostate).
    6. Urine culture may be indicated to detect occult infection in 
renal transplant recipients on immunosuppressive therapy.

Limitations

    1. CPT 87086 or 87087 may be used one time per encounter. CPT 87086 
and 87087 are not used concurrently.
    2. Colony count restrictions on coverage of CPT 87088 do not apply 
as

[[Page 58812]]

they may be highly variable according to syndrome or other clinical 
circumstances (for example , antecedent therapy, collection time, 
degree of hydration).
    3. CPT 87088, 87184, and 87186 may be used multiple times in 
association with or independent of 87086 or 87087, as urinary tract 
infections may be polymicrobial.
    4. Testing for asymptomatic bacteriuria as part of a prenatal 
evaluation may be medically appropriate but is considered screening and 
therefore not covered by Medicare. The US Preventive Services Task 
Force has concluded that screening for asymptomatic bacteriuria outside 
of the narrow indication for pregnant women is generally not indicated. 
There are insufficient data to recommend screening in ambulatory 
elderly patients including those with diabetes. Testing may be 
clinically indicated on other grounds including likelihood of 
recurrence or potential adverse effects of antibiotics, but is 
considered screening in the absence of clinical or laboratory evidence 
of infection.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
003.1.......................................  Salmonella Septicemia
038.0-038.9.................................  Septicemia
276.2.......................................  Acidosis
276.4.......................................  Metabolic acidosis/alkalosis
286.6.......................................  Defibrination syndrome/disseminated intravascular coagulation
288.0.......................................  Agranulocytosis/neutropenia
288.8.......................................  Other specified disease of white blood cells including leukemoid
                                               reaction/leukocytosis
306.53......................................  Psychogenic dysuria
306.59......................................  Other psychogenic genitourinary malfunction
518.82......................................  Other pulmonary insufficiency, not elsewhere classified
570.........................................  Acute and subacute necrosis of liver
580.0-580.9.................................  Acute glomerulonephritis
583.0-583.9.................................  Nephritis and Nephropathy, not specified as acute or chronic
584.5.......................................  Acute renal failure, with lesion of tubular necrosis
584.9.......................................  Acute renal failure, unspecified
585.........................................  Chronic renal failure
586.........................................  Renal failure, unspecified
590.00-590.9................................  Infections of kidney/pyelonephritis acute and chronic
592.0-592.9.................................  Calculus of kidney and ureter
593.0-593.9.................................  Other disorders of kidney and ureter (cyst, stricture,
                                               obstruction, reflux, etc.)
594.0-594.9.................................  Calculus of lower urinary tract
595.0-595.9.................................  Cystitis
597.0.......................................  Urethritis, not sexually transmitted and urethral syndrome
597.80-597.89...............................  Other urethritis
598.00-598.01...............................  Urethral stricture due to infection
599.0.......................................  Urinary tract infection, site not specified
599.7.......................................  Hematuria
600.........................................  Hyperplasia of prostate
601.0-601.9.................................  Inflammatory diseases of prostate
602.0-602.9.................................  Other disorders of prostate (calculus, congestion, atrophy, etc.)
604.0-604.99................................  Orchitis and epididymitis
608.0-608.9.................................  Other disorders of male genital organs (seminal vesiculitis,
                                               spermatocele, etc.)
614.0-614.9.................................  Inflammatory disease of ovary, fallopian tube, pelvic cellular
                                               tissue, and peritoneum
615.0-615.9.................................  Inflammatory disease of uterus, except cervix
616.0.......................................  Cervicitis and endocervicitis
616.10-616.11...............................  Vaginitis and vulvovaginitis
616.2-616.9.................................  Other inflammatory conditions of cervix, vagina and vulva
619.0-619.9.................................  Fistula involving female genital tract
625.6.......................................  Stress incontinence, female
639.0.......................................  Genital tract and pelvic infection complicating abortion, ectopic
                                               or molar pregnancies
639.5.......................................  Shock complicating abortion, ectopic or molar pregnancies
646.60-.64..................................  Infections of genitourinary tract in pregnancy
670.00-.04..................................  Major puerperal infection
672.00-.04..................................  Pyrexia of unknown origin during the puerperium
724.5.......................................  Backache, unspecified
780.2.......................................  Syncope and collapse
780.6.......................................  Fever (Hyperthermia)
780.79......................................  Other malaise and fatigue
780.9.......................................  Other general symptoms (altered mental status, chills, generalized
                                               pains)
785.0.......................................  Tachycardia, unspecified
785.50-.59..................................  Shock without mention of trauma
788.0-788.9.................................  Symptoms involving urinary system (renal colic, dysuria, retention
                                               of urine, incontinence of urine, frequency, polyuria, nocturia,
                                               oliguria, anuria, other abnormality of urination, urethral
                                               discharge, extravasation of urine, other symptoms of urinary
                                               system)
789.00-789.09...............................  Abdominal pain
789.60-789.69...............................  Abdominal tenderness
790.7.......................................  Bacteremia
791.0-791.9.................................  Nonspecific findings on examination of urine (proteinuria,
                                               chyluria, hemoglobinuria, myoglobinuria, biliuria, glycosuria,
                                               acetonuria, other cells and casts in urine, other nonspecific
                                               findings on examination of urine)

[[Page 58813]]


799.3.......................................  Debility, unspecified (only for declining functional status)
939.0.......................................  Foreign body in genitourinary tract, bladder and urethra
939.3.......................................  Foreign body in genitourinary tract, penis
V44.50-V44.6................................  Artificial cystostomy or other artificial opening of urinary tract
                                               status
V55.5-V55.6.................................  Attention to cystostomy or other artificial opening of urinary
                                               tract
V58.69......................................  Long-term (current) use of other medications
V72.84......................................  Pre-operative examination, unspecified
----------------------------------------------------------------------------------------------------------------

Reasons for Denial

    Note: This section has not been negotiated by the Negotiated 
Rulemaking Committee. It includes HCFA's interpretation of its 
longstanding policies and is included for informational purposes.

     Tests for screening purposes that are performed in the 
absence of signs, symptoms, complaints, or personal history of disease 
or injury are not covered except as explicitly authorized by statute. 
These include exams required by insurance companies, business 
establishments, government agencies, or other third parties.
     Tests that are not reasonable and necessary for the 
diagnosis or treatment of an illness or injury are not covered 
according to the statute.
     Failure to provide documentation of the medical necessity 
of tests may result in denial of claims. The documentation may include 
notes documenting relevant signs, symptoms, or abnormal findings that 
substantiate the medical necessity for ordering the tests. In addition, 
failure to provide independent verification that the test was ordered 
by the treating physician (or qualified nonphysician practitioner) 
through documentation in the physician's office may result in denial.
     A claim for a test for which there is a national coverage 
or local medical review policy will be denied as notreasonable and 
necessary if it is submitted without an ICD-9-CM code or narrative 
diagnosis listed as covered in the policy unless other medical 
documentation justifying the necessity is submitted with the claim.
     If a national or local policy identifies a frequency 
expectation, a claim for a test that exceeds that expectation may be 
denied as not reasonable and necessary, unless it is submitted with 
documentation justifying increased frequency.
     Tests that are not ordered by a treating physician or 
other qualified treating nonphysician practitioner acting within the 
scope of their license and in compliance with Medicare requirements 
will be denied as not reasonable and necessary.
     Failure of the laboratory performing the test to have the 
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
certificate for the testing performed will result in denial of claims.

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs
V16.5.......................................  Family history of malignant neoplasm, urinary organs
V16.6.......................................  Family history of malignant neoplasm, leukemia
V16.7.......................................  Family history of malignant neoplasm, other lymphatic and
                                               hematopoietic neoplasms
V16.8.......................................  Family history of malignant neoplasm, other specified malignant
                                               neoplasm
V16.9.......................................  Family history of malignant neoplasm, unspecified malignant
                                               neoplasm
V17.0-V17.8.................................  Family history of certain chronic disabling diseases
V18.0-V18.8.................................  Family history of certain other specific conditions
V19.0-V19.8.................................  Family history of other conditions
V20.0-V20.2.................................  Health supervision of infant or child
V28.0-V28.9.................................  Antenatal screenings
V50.0-V50.9.................................  Elective surgery for purposes other than remedying health states
V53.2.......................................  Fitting and adjustment of hearing aid
V60.0-V60.9.................................  Housing, household, and economic circumstances
V62.0.......................................  Unemployment
V62.1.......................................  Adverse effects of work environment
V65.0.......................................  Healthy persons accompanying sick persons
V65.1.......................................  Persons consulting on behalf of another person
V68.0-V68.9.................................  Encounters for administrative purposes
V70.0-V70.9.................................  General medical examinations
V73.0-V73.99................................  Special screening examinations for viral and chlamydia diseases
V74.0-V74.9.................................  Special screening examinations for bacterial and spirochetal
                                               diseases
V75.0-V75.9.................................  Special screening examination for other infectious diseases
V76.0.......................................  Special screening for malignant neoplasms, respiratory organs
V76.3.......................................  Special screening for malignant neoplasms, bladder
V76.42-V76.9................................  Special screening for malignant neoplasms, (sites other than
                                               breast, cervix, and rectum)
V77.0-V77.9.................................  Special screening for endocrine, nutrition, metabolic, and
                                               immunity disorders
V78.0-V78.9.................................  Special Screening for disorders of blood and blood-forming organs
V79.0-V.79.9................................  Special screening for mental disorders
V80.0-V80.3.................................  Special screening for neurological, eye, and ear diseases
V81.0-V81.6.................................  Special screening for cardiovascular, respiratory, and
                                               genitourinary diseases

[[Page 58814]]


V82.0-V82.9.................................  Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

    Any ICD-9-CM code not listed in either of the ICD-9-CM sections.

Sources of Information

    Bone, RC, RA Bal, FB Cerra, and the ACCP/SCCM Consensus Conference 
Committee. 1992. Definitions for sepsis and organ failure and 
guidelines for the use of innovative therapies in sepsis. Chest 
101:1644-1655.
    Clarridge, JE, JR Johnson, and MT Pezzlo. 1998 (in press). Cumitech 
2B: Laboratory Diagnosis of Urinary Tract Infections. AS Weissfeld 
(coor. ed.); ASM Press, Washington, DC.
    Kunin, CM. 1994. Urinary tract infections in females. Clin. Infect. 
Dis. 18:1-12.
    Sodeman, TM. 1995. A practical strategy for diagnosis of urinary 
tract infections. Clin. Lab. Med. 15:235-250.
    Stamm WE, and TM Hooton. 1993. Management of urinary tract 
infections in adults. N. Engl. J. Med. 329:1328-1334.
    United States Preventive Services Task Force (1996). Guidelines for 
screening for asymptomatic bacteriuria.
    Lachs MS, Nachamkin I, Edelstein PH et al. 1992. Spectrum bias in 
the evaluation of diagnostic tests: lessons from the rapid dipstick 
test for urinary tract infection. Ann. Int. Med. 117:135-140.

Coding Guidelines

    1. Any claim for a test listed in ``HCPCS Codes'' above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
Codes that describe symptoms and signs, as opposed to diagnoses, should 
be provided for reporting purposes when a diagnosis has not been 
established by the physician. (Based on Coding Clinic for ICD-9-CM, 
Fourth Quarter 1995, page 43).
    2. Screening is the testing for disease or disease precursors so 
that early detection and treatment can be provided for those who test 
positive for the disease. Screening tests are performed when no 
specific sign, symptom, or diagnosis is present and the patient has not 
been exposed to a disease. The testing of a person to rule out or to 
confirm a suspected diagnosis because the patient has a sign and/or 
symptom is a diagnostic test, not a screening. In these cases, the sign 
or symptom should be used to explain the reason for the test. When the 
reason for performing a test is because the patient has had contact 
with, or exposure to, a communicable disease, the appropriate code from 
category V01, Contact with or exposure to communicable diseases, should 
be assigned, not a screening code, but the test may still be considered 
screening and not covered by Medicare. For screening tests, the 
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or 
comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, 
Fourth Quarter 1996, pages 50 and 52).
    3. A three-digit code is to be used only if it is not further 
subdivided. Where fourth-digit and/or fifth-digit subclassifications 
are provided, they must be assigned. A code is invalid if it has not 
been coded to the full number of digits required for that code. (From 
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44).
    4. Diagnoses documented as ``probable,'' ``suspected,'' 
``questionable,'', ``rule-out,'' or ``working diagnosis'' should not be 
coded as though they exist. Rather, code the condition(s) to the 
highest degree of certainty for that encounter/visit, such as signs, 
symptoms, abnormal test results, exposure to communicable disease or 
other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth 
Quarter 1995, page 45).
    5. When a non-specific ICD-9 code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for the 
test.
    6. In the case of pre-operative examination (V72.84), the following 
codes may support medical necessity: 585, 586, 592.0-592.9, 594.0-
594.9, 600, 602.0-602.9, 939.0, 939.3.
    7. Specific coding guidelines:
    a. Use CPT 87086 Culture, bacterial, urine; quantitative, colony 
count where a urine culture colony count is performed to determine the 
approximate number of bacteria present per milliliter of urine. The 
number of units of service is determined by the number of specimens.
    b. Use CPT 87087 Culture, bacterial, urine; commercial kit where a 
commercial kit uses manufacturer defined media for isolation, 
presumptive identification, and quantitation of morphotypes present. 
The number of units of service is determined by the number of 
specimens.
    c. Use CPT 87088 Culture, bacterial, urine; identification in 
addition to quantitative or commercial kit where identification of 
morphotypes recovered by quantitative culture or commercial kits and 
deemed to represent significant bacteriuria requires the use of 
additional testing, for example, biochemical test procedures on 
colonies. Identification based solely on visual observation of the 
primary media is usually not adequate to justify use of this code. The 
number of units of service is determined by the number of isolates.
    d. Use CPT 87184 or 87186, Sensitivity studies where susceptibility 
testing of isolates deemed to be significant is performed concurrently 
with identification. The number of units of service is determined by 
the number of isolates. These codes are not exclusively used for urine 
cultures but are appropriate for isolates from other sources as well.
    e. Appropriate combinations are as follows: CPT 87086 or 87087, 1 
per specimen with 87088, 1 per isolate and 87184 or 87186 where 
appropriate.
    f. Culture for other specific organism groups not ordinarily 
recovered by media used for aerobic urine culture may require use of 
additional CPT codes (for example, anaerobes from suprapubic samples).
    g. Identification of isolates by non-routine, nonbiochemical 
methods may be coded appropriately (for example, immunologic 
identification of streptococci, nucleic acid techniques for 
identification of N. gonorrhoeae).
    h. While infrequently used, sensitivity studies by methods other 
than CPT 87184 or 87186 are appropriate. CPT 87181, agar dilution 
method, each antibiotic or CPT 87188, macrotube dilution method, each 
antibiotic may be used. The number of units of service is the number of 
antibiotics multiplied by the number of unique isolates.
    8. ICD-9-CM code 780.02, 780.9 or 799.3 should be used only in the 
situation of an elderly patient, immunocompromised patient or patient 
with neurologic disorder who presents without typical manifestations of 
a urinary tract infection but who presents with one of the following 
signs or symptoms, not otherwise explained by another co-existing 
condition: increasing debility; declining functional status; acute 
mental changes; changes in awareness; or hypothermia.
    9. In cases of post renal-transplant urine culture used to detect 
clinically

[[Page 58815]]

significant occult infection in patients on long term immunosuppressive 
therapy, use code V58.69.

Documentation Requirements

    Appropriate HCPCS/CPT code(s) must be used as described.

National Coverage Decision for: Human Immunodeficiency Virus Testing 
(Prognosis including monitoring)
Other Names/Abbreviations: HIV-1 or HIV-2 quantification or viral load

Description

    HIV quantification is achieved through the use of a number of 
different assays which measure the amount of circulating viral RNA. 
Assays vary both in methods used to detect viral RNA as well as in 
ability to detect viral levels at lower limits. However, all employ 
some type of nucleic acid amplification technique to enhance 
sensitivity, and results are expressed as the HIV copy number.
    Quantification assays of HIV plasma RNA are used prognostically to 
assess relative risk for disease progression and predict time to death, 
as well as to assess efficacy of antiretroviral therapies over time.
    HIV quantification is often performed together with CD4+ T cell 
counts which provide information on extent of HIV induced immune system 
damage already incurred.

HCPCS Codes (alpha numeric, CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
7536........................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-1,
                                               quantification
87539.......................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-2,
                                               quantification
----------------------------------------------------------------------------------------------------------------

Indications

    1. A plasma HIV RNA baseline level may be medically necessary in 
any patient with confirmed HIV infection.
    2. Regular periodic measurement of plasma HIV RNA levels may be 
medically necessary to determine risk for disease progression in an 
HIV-infected individual and to determine when to initiate or modify 
antiretroviral treatment regimens.
    3. In clinical situations where the risk of HIV infection is 
significant and initiation of therapy is anticipated, a baseline HIV 
quantification may be performed. These situations include:
    a. Persistence of borderline or equivocal serologic reactivity in 
an at-risk individual.
    b. Signs and symptoms of acute retroviral syndrome characterized by 
fever, malaise, lymphadenopathy and rash in an at-risk individual.

Limitations

    1. Viral quantification may be appropriate for prognostic use 
including baseline determination, periodic monitoring, and monitoring 
of response to therapy. Use as a diagnostic test method is not 
indicated.
    2. Measurement of plasma HIV RNA levels should be performed at the 
time of establishment of an HIV infection diagnosis. For an accurate 
baseline, 2 specimens in a 2-week period are appropriate.
    3. For prognosis including anti-retroviral therapy monitoring, 
regular, periodic measurements are appropriate. The frequency of viral 
load testing should be consistent with the most current Centers for 
Disease Control and Prevention guidelines for use of anti-retroviral 
agents in adults and adolescents or pediatrics.
    4. Because differences in absolute HIV copy number are known to 
occur using different assays, plasma HIV RNA levels should be measured 
by the same analytical method. A change in assay method may necessitate 
re-establishment of a baseline.
    5. Nucleic acid quantification techniques are representative of 
rapidly emerging and evolving new technologies. As such, users are 
advised to remain current on FDA-approval status.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
042.........................................  Human immunodeficiency virus [HIV] disease
079.53......................................  Human immunodeficiency virus, type 2 [HIV-2]
647.60-.64..................................  Other viral diseases complicating pregnancy (including HIV-I and
                                               II)
795.71......................................  Nonspecific serologic evidence of human immunodeficiency virus
                                               [HIV]
V08.........................................  Asymptomatic human immunodeficiency virus [HIV] infection status
----------------------------------------------------------------------------------------------------------------

Reasons for Denial

    Note: This section was not negotiated by the Negotiated 
Rulemaking Committee. It includes HCFA's interpretation of its 
longstanding policies and is included for informational purposes.

     Tests for screening purposes that are performed in the 
absence of signs, symptoms, complaints, or personal history of disease 
or injury are not covered except as explicitly authorized by statute. 
These include exams required by insurance companies, business 
establishments, government agencies, or other third parties.
     Tests that are not reasonable and necessary for the 
diagnosis or treatment of an illness or injury are not covered 
according to the statute.
     Failure to provide documentation of the medical necessity 
of tests may result in denial of claims. The documentation may include 
notes documenting relevant signs, symptoms or abnormal findings that 
substantiate the medical necessity for ordering the tests. In addition, 
failure to provide independent verification that the test was ordered 
by the treating physician (or qualified nonphysician practitioner) 
through documentation in the physician's office may result in denial.
     A claim for a test for which there is a national coverage 
or local medical review policy will be denied as not reasonable and 
necessary if it is submitted without an ICD-9-CM code or narrative 
diagnosis listed as covered in the policy unless other medical 
documentation justifying the necessity is submitted with the claim.
     If a national or local policy identifies a frequency 
expectation, a claim for a test that exceeds that expectation may be 
denied as not

[[Page 58816]]

reasonable and necessary, unless it is submitted with documentation 
justifying increased frequency.
     Tests that are not ordered by a treating physician or 
other qualified treating nonphysician practitioner acting within the 
scope of their license and in compliance with Medicare requirements 
will be denied as not reasonable and necessary.
     Failure of the laboratory performing the test to have the 
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
certificate for the testing performed will result in denial of claims.

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs
V16.5.......................................  Family history of malignant neoplasm, urinary organs
V16.6.......................................  Family history of malignant neoplasm, leukemia
V16.7.......................................  Family history of malignant neoplasm, other lymphatic and
                                               hematopoietic neoplasms
V16.8.......................................  Family history of malignant neoplasm, other specified malignant
                                               neoplasm
V16.9.......................................  Family history of malignant neoplasm, unspecified malignant
                                               neoplasm
V17.0-V17.8.................................  Family history of certain chronic disabling diseases
V18.0-V18.8.................................  Family history of certain other specific conditions
V19.0-V19.8.................................  Family history of other conditions
V20.0-V20.2.................................  Health supervision of infant or child
V28.0-V28.9.................................  Antenatal screenings
V50.0-V50.9.................................  Elective surgery for purposes other than remedying health states
V53.2.......................................  Fitting and adjustment of hearing aid
V60.0-V60.9.................................  Housing, household, and economic circumstances
V62.0.......................................  Unemployment
V62.1.......................................  Adverse effects of work environment
V65.0.......................................  Healthy persons accompanying sick persons
V65.1.......................................  Persons consulting on behalf of another person
V68.0-V68.9.................................  Encounters for administrative purposes
V70.0-V70.9.................................  General medical examinations
V73.0-V73.99................................  Special screening examinations for viral and chlamydia diseases
V74.0-V74.9.................................  Special screening examinations for bacterial and spirochetal
                                               diseases
V75.0-V75.9.................................  Special screening examination for other infectious diseases
V76.0.......................................  Special screening for malignant neoplasms, respiratory organs
V76.3.......................................  Special screening for malignant neoplasms, bladder
V76.42-V76.9................................  Special screening for malignant neoplasms, (sites other than
                                               breast, cervix, and rectum)
V77.0-V77.9.................................  Special screening for endocrine, nutrition, metabolic, and
                                               immunity disorders
V78.0-V78.9.................................  Special Screening for disorders of blood and blood-forming organs
V79.0-V.79.9................................  Special screening for mental disorders
V80.0-V80.3.................................  Special screening for neurological, eye, and ear diseases
V81.0-V81.6.................................  Special screening for cardiovascular, respiratory, and
                                               genitourinary diseases
V82.0-V82.9.................................  Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

    Any ICD-9-CM code not listed in either of the ICD-9-CM sections 
above.

Sources of Information

    CDC. 1998. Guidelines for the use of antiretroviral agents in HIV-
infected adults and adolescents. MMWR 47 (RR-5).
    CDC. 1998. Guidelines for the use of antiretroviral agents in 
pediatric HIV infection. MMWR 47 (RR-4).
    CDC. 1998. Public Health Service Task Force recommendations for the 
use of antiretroviral drugs in pregnant women infected with HIV-1 for 
maternal health and for reducing perinatal HIV-1 transmission in the 
United States. MMWR 47 (RR-2).
    Carpenter, C.C., M.A. Fischi, S.M. Hammer, et al. 1998. 
Antiretroviral therapy for HIV infection in 1998. Updated 
recommendations of the international AIDS society-USA panel. .A.M.A. 
280:78-86.
    Saag, M.S., M. Holodniy, D.R. Kuritzkes, et al. 1996. HIV viral 
load markers in clinical practice. Nature Medicine 2(6): 625-629.

Coding Guidelines

    1. Any claim for a test listed in ``HCPCS CODES'' above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
Codes that describe symptoms and signs, as opposed to diagnoses, should 
be provided for reporting purposes when a diagnosis has not been 
established by the physician. (Based on Coding Clinic for ICD-9-CM, 
Fourth Quarter 1995, page 43.)
    2. Screening is the testing for disease precursors so that early 
detection and treatment can be provided for those who test positive for 
the disease. Screening tests are performed when no specific sign, 
symptom, or diagnosis is present and the patient has not been exposed 
to a disease. The testing of a person to rule out or to confirm a 
suspected diagnosis because the patient has a sign and/or symptom is a 
diagnostic test, not a screening. In these cases, the sign or symptom 
should be used to explain the reason for the test. When the reason for 
performing a test is because the patient has had contact with, or 
exposure to, a communicable disease, the appropriate code from category 
V01, Contact with or exposure to communicable diseases, should be 
assigned, not a screening code, but the test may still be considered 
screening and not covered by Medicare. For screening tests, the 
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or 
comparable narrative) should be used.

[[Page 58817]]

(From Coding Clinic for ICD-9-CM, Fourth Quarter 1996, pages 50 and 
52.)
    3. A three-digit code is to be used only if it is not further 
subdivided. Where fourth-digit and/or fifth-digit subclassifications 
are provided, they must be assigned. A code is invalid if it has not 
been coded to the full number of digits required for that code. (From 
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)
    4. Diagnoses documented as ``probable,'' ``suspected,'' 
``questionable,'' ``rule-out,'' or ``working diagnosis'' should not be 
coded as though they exist. Rather, code the condition(s) to the 
highest degree of certainty for that encounter/visit, such as signs, 
symptoms, abnormal test results, exposure to communicable disease or 
other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth 
Quarter 1995, page 45.)
    5. When a non-specific ICD-9 code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for the 
test above.
    6. Specific coding guidelines:
    a. Temporary code G0100 has been superseded by code 87536 effective 
January 1, 1998.
    b. CPT codes for quantification should not be used simultaneously 
with other nucleic acid detection codes for HIV-1 (that is, 87534, 
87535) or HIV-2 (that is, 87537, 87538).
    7. Codes 647.60-.64 should only be used for HIV infections 
complicating pregnancy.

Other Comments

    Assessment of CD4+ T cell numbers is frequently performed in 
conjunction with viral load determination. When used in concert, the 
accuracy with which the risk for disease progression and death can be 
predicted is enhanced.

Medicare National Coverage Decision For: Human Immunodeficiency Virus 
Testing (Diagnosis).

Other Names/Abbreviations: HIV, HIV-1, HIV-2, HIV1/2, HTLV III, Human 
T-cell lymphotrophic virus, AIDS, Acquired immune deficiency syndrome.

Description

    Diagnosis of Human Immunodeficiency Virus (HIV) infection is 
primarily made through the use of serologic assays. These assays take 
one of two forms: antibody detection assays and specific HIV antigen 
(p24) procedures. The antibody assays are usually enzyme immunoassays 
(EIA) which are used to confirm exposure of an individual's immune 
system to specific viral antigens. These assays may be formatted to 
detect HIV-1, HIV-2, or HIV-1 and 2 simultaneously and to detect both 
IgM and IgG. When the initial EIA test is repeatedly positive or 
indeterminant, an alternative test is used to confirm the specificity 
of the antibodies to individual viral components. The most commonly 
used method is the Western Blot.
    The HIV-1 core antigen (p24) test detects circulating viral antigen 
which may be found prior to the development of antibodies and may also 
be present in later stages of illness in the form of recurrent or 
persistent antigenemia. Its prognostic utility in HIV infection has 
been diminished as a result of development of sensitive viral RNA 
assays, and its primary use today is as a routine screening tool in 
potential blood donors.
    In several unique situations, serologic testing alone may not 
reliably establish an HIV infection. This may occur because the 
antibody response (particularly the IgG response detected by Western 
Blot) has not yet developed (that is, acute retroviral syndrome), or is 
persistently equivocal because of inherent viral antigen variability. 
It is also an issue in perinatal HIV infection due to transplacental 
passage of maternal HIV antibody. In these situations, laboratory 
evidence of HIV in blood by culture, antigen assays, or proviral DNA or 
viral RNA assays, is required to establish a definitive determination 
of HIV infection.

HCPCS Codes (alpha numeric, CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
86689.......................................  Qualitative or semiquantitative immunoassays performed by multiple
                                               step methods; HTLV or HIV antibody, confirmatory test (for
                                               example, Western Blot)
86701.......................................  Qualitative or semiquantitative immunoassays performed by multiple
                                               step methods; HIV-1
86702.......................................  Qualitative or semiquantitative immunoassays performed by multiple
                                               step methods; HIV-2
86703.......................................  Qualitative or semiquantitative immunoassays performed by multiple
                                               step methods; HIV-1 and HIV-2, single assay
87390.......................................  Infectious agent antigen detection by enzyme immunoassay
                                               technique, qualitative or semiquantitative, multiple step; HIV-1
87391.......................................  Infectious agent antigen detection by enzyme immunoassay
                                               technique, qualitative or semiquantitative, multiple step; HIV-2
87534.......................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-1,
                                               direct probe technique
87535.......................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-1,
                                               direct probe technique HIV-1, amplified probe technique
87537.......................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-2,
                                               direct probe technique
87538.......................................  Infectious agent detection by nucleic acid (DNA or RNA); HIV-2,
                                               amplified probe technique
----------------------------------------------------------------------------------------------------------------

Indications

    Diagnostic testing to establish HIV infection may be indicated when 
there is a strong clinical suspicion supported by one or more of the 
following clinical findings:
    1. The patient has a documented, otherwise unexplained, AIDS-
defining or AIDS-associated opportunistic infection.
    2. The patient has another documented sexually transmitted disease 
which identifies significant risk of exposure to HIV and the potential 
for an early or subclinical infection.
    3. The patient has documented acute or chronic hepatitis B or C 
infection that identifies a significant risk of exposure to HIV and the 
potential for an early or subclinical infection.
    4. The patient has a documented AIDS-defining or AIDS-associated 
neoplasm.
    5. The patient has a documented AIDS-associated neurologic disorder 
or otherwise unexplained dementia.
    6. The patient has another documented AIDS-defining clinical 
condition, or a history of other severe, recurrent, or persistent 
conditions which suggest an underlying immune deficiency (for example, 
cutaneous or mucosal disorders).
    7. The patient has otherwise unexplained generalized signs and

[[Page 58818]]

symptoms suggestive of a chronic process with an underlying immune 
deficiency (for example, fever, weight loss, malaise, fatigue, chronic 
diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of 
breath, or lymphadenopathy).
    8. The patient has otherwise unexplained laboratory evidence of a 
chronic disease process with an underlying immune deficiency (for 
example, anemia, leukopenia, pancytopenia, lymphopenia, or low CD4+ 
lymphocyte count).
    9. The patient has signs and symptoms of acute retroviral syndrome 
with fever, malaise, lymphadenopathy, and skin rash.
    10. The patient has documented exposure to blood or body fluids 
known to be capable of transmitting HIV (for example, needlesticks and 
other significant blood exposures) and antiviral therapy is initiated 
or anticipated to be initiated.
    11. The patient is undergoing treatment for rape. (HIV testing is a 
part of the rape treatment protocol.) For a comprehensive tabulation of 
AIDS-defining and AIDS associated conditions, refer to information 
source document #5.

Limitations

    1. HIV antibody testing in the United States is usually performed 
using HIV-1 or HIV-\1/2\ combination tests. HIV-2 testing is indicated 
if clinical circumstances suggest HIV-2 is likely (that is, compatible 
clinical findings and HIV-1 test negative). HIV-2 testing may also be 
indicated in areas of the country where there is greater prevalence of 
HIV-2 infections.
    2. The Western Blot test should be performed only after 
documentation that the initial EIA tests are repeatedly positive or 
equivocal on a single sample.
    3. The HIV antigen tests currently have no defined diagnostic 
usage.
    4. Direct viral RNA detection may be performed in those situations 
where serologic testing does not establish a diagnosis but strong 
clinical suspicion persists (for example, acute retroviral syndrome, 
nonspecific serologic evidence of HIV, or perinatal HIV infection).
    5. If initial serologic tests confirm an HIV infection, repeat 
testing is not indicated.
    6. If initial serologic tests are HIV EIA negative and there is no 
indication for confirmation of infection by viral RNA detection, the 
interval prior to retesting is 3-6 months.
    7. Testing for evidence of HIV infection using serologic methods 
may be medically appropriate in situations where there is a risk of 
exposure to HIV. However, in the absence of a documented AIDS defining 
or HIV associated disease, an HIV associated sign or symptom, or 
documented exposure to a known HIV-infected source, the testing is 
considered by Medicare to be screening and thus is not covered by 
Medicare (for example, history of multiple blood component 
transfusions, exposure to blood or body fluids not resulting in 
consideration of therapy, history of transplant, history of illicit 
drug use, multiple sexual partners, same-sex encounters, prostitution, 
or contact with prostitutes).
    8. The CPT Editorial Panel has issued a number of codes for 
infectious agent detection by direct antigen or nucleic acid probe 
techniques that have not yet been developed or are only being used on 
an investigational basis. Laboratory providers are advised to remain 
current on FDA-approval status for these tests.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
003.1.......................................  Salmonella septicemia
007.2.......................................  Coccidiosis (Isoporiasis)
007.4.......................................  Cryptosporidiosis
007.8.......................................  Other specified protozoal intestinal diseases
010.00-010.96...............................  Primary tuberculous infection
011.00-011.96...............................  Pulmonary tuberculosis
012.00-012.86...............................  Other respiratory tuberculosis
013.00-013.96...............................  Tuberculosis of meninges and central nervous system
014.00-014.86...............................  Tuberculosis of intestines, peritoneum and mesenteric glands
015.00-015.96...............................  Tuberculosis of bones and joints
016.00-016.96...............................  Tuberculosis of genitourinary system
017.00-017.96...............................  Tuberculosis of other organs
018.00-018.96...............................  Miliary tuberculosis
027.0.......................................  Listeriosis
031.0-031.9.................................  Diseases due to other mycobacteria
038.2.......................................  Pneumococcal septicemia
038.43......................................  Septicemia (Pseudomonas)
039.0-.9....................................  Actinomycotic infections (includes Nocardia)
041.7.......................................  Pseudomonas infection
042.........................................  HIV disease (Acute retroviral syndrome, AIDS-related complex)
046.3.......................................  Progressive multifocal leukoencephalopathy
049.0-049.9.................................  Other non-arthropod-borne viral diseases of central nervous system
052.0-052.8.................................  Chickenpox (with complication)
053.0-053.9.................................  Herpes zoster
054.0-054.9.................................  Herpes simplex
055.0-055.8.................................  Measles (with complication)
070.20-070.23...............................  Viral hepatitis B with hepatic coma
070.30-070.33...............................  Viral hepatitis B without mention of hepatic coma
070.41......................................  Acute or unspecified hepatitis C with hepatic coma
070.42......................................  Hepatitis delta without mention of active hepatitis B disease with
                                               hepatic coma
070.44......................................  Chronic hepatitis C with hepatic coma
070.49......................................  Other specified viral hepatitis with hepatic coma
070.51......................................  Acute or unspecified hepatitis C without hepatic coma
070.52......................................  Hepatitis delta without mention of active hepatitis B disease
                                               without hepatic coma
070.54......................................  Chronic hepatitis C without hepatic coma
070.59......................................  Other specified viral hepatitis without hepatic coma

[[Page 58819]]


070.6.......................................  Unspecified viral hepatitis with hepatic coma
070.9.......................................  Unspecified viral hepatitis without hepatic coma
078.0.......................................  Molluscum contagiosum
078.10-078.19...............................  Viral warts
078.3.......................................  Cat-scratch disease
078.5.......................................  Cytomegaloviral disease
078.88......................................  Other specified diseases due to Chlamydiae
079.50......................................  Retrovirus unspecified
079.51......................................  HTLV-I
079.52......................................  HTLV-II
079.53......................................  HTLV-III
079.59......................................  Other specified Retrovirus
079.88......................................  Other specified chlamydial infection
079.98......................................  Unspecified chlamydial infection
085.0-085.9.................................  Leishmaniasis
088.0.......................................  Bartonellosis
090.0-090.9.................................  Congenital syphilis
091.0-091.9.................................  Early syphilis symptomatic
092.0-092.9.................................  Early syphilis, latent
093.0-093.9.................................  Cardiovascular syphilis
094.0-094.9.................................  Neurosyphilis
095.0-095.9.................................  Other forms of late syphilis, with symptoms
096.........................................  Late syphilis, latent
097.0-097.9.................................  Other and unspecified syphilis
098.0-098.89................................  Gonococcal infections
099.0.......................................  Chancroid
099.1.......................................  Lymphogranuloma venereum
099.2.......................................  Granuloma inguinale
099.3.......................................  Reiter's disease
099.40-099.49...............................  Other nongonococcal urethritis
099.50-099.59...............................  Other venereal diseases due to Chlamydia trachomatis
099.8.......................................  Other specified venereal disease
099.9.......................................  Venereal disease unspecified
110.1.......................................  Dermatophytosis of nail
111.0.......................................  Pityriasis versicolor
112.0-112.9.................................  Candidiasis
114.0-114.9.................................  Coccidioidomycosis
115.00-115.99...............................  Histoplasmosis
116.0-116.2.................................  Blastomycotic infection
117.3.......................................  Aspergillosis
117.5.......................................  Cryptococcosis
118.........................................  Opportunistic mycoses
127.2.......................................  Strongyloidiasis
130.0-130.9.................................  Toxoplasmosis
131.01......................................  Trichomonal vulvovaginitis
132.2.......................................  Phthirus pubis
133.0.......................................  Scabies
136.2.......................................  Specific infections by free living amebae
136.3.......................................  Pneumocystosis
136.8.......................................  Other specified infectious and parasitic disease (for example,
                                               microsporidiosis)
176.0-176.9.................................  Kaposi's sarcoma
180.0-180.9.................................  Malignant neoplasm of cervix uteri
200.20-200.28...............................  Burkitt's tumor or lymphoma
200.80-200.88...............................  Lymphosarcoma, other named variants
201.00-201.98...............................  Hodgkin's disease
263.0.......................................  Malnutrition of moderate degree
263.1.......................................  Malnutrition of mild degree
263.9.......................................  Unspecified protein-calorie malnutrition
280.0-280.9.................................  Iron deficiency anemias
285.9.......................................  Anemia, unspecified
287.3.......................................  Primary thrombocytopenia
288.0.......................................  Agranulocytosis
288.8.......................................  Other specified disease of white blood cells
294.8.......................................  Other specified organic brain syndromes (chronic)
310.1.......................................  Organic personality syndrome
322.2.......................................  Chronic meningitis
336.9.......................................  Unspecified disease of spinal cord
348.3.......................................  Encephalopathy unspecified
354.0-354.9.................................  Mononeuritis of upper limbs and mononeuritis multiplex
356.8.......................................  Other specified idiopathic peripheral neuropathy
363.20......................................  Chorioretinitis, unspecified
425.4.......................................  Other primary cardiomyopathies
473.0-473.9.................................  Chronic sinusitis
481.0-482.9.1...............................  Pneumococcal pneumonia

[[Page 58820]]


484.1.......................................  Pneumonia in cytomegalic inclusion disease
486.........................................  Pneumonia, organism unspecified
512.8.......................................  Other spontaneous pneumothorax
516.8.......................................  Other specified alveolar and parietoalveolar pneumonopathies
528.2.......................................  Oral aphthae
528.6.......................................  Leukoplakia of oral mucosa
530.2.......................................  Ulcer of esophagus
583.9.......................................  Nephropathy with unspecified pathological lesion in kidney
588.8.......................................  Other specified disorders resulting from impaired renal function
647.60-647.64...............................  Other viral diseases complicating pregnancy (use for HIV I and II)
682.0-682.9.................................  Other cellulitis and abscess
690.10-690.18...............................  Seborrheic dermatitis
696.1.......................................  Other psoriasis
698.3.......................................  Lichenification and lichen simplex chronicus
704.8.......................................  Other specified diseases of hair and hair follicles
706.0-706.9.................................  Diseases of sebaceous glands
780.6.......................................  Fever
780.79......................................  Other malaise and fatigue
783.2.......................................  Abnormal loss of weight
783.4.......................................  Lack of expected normal physiological development
785.6.......................................  Enlargement of lymph nodes
786.00......................................  Respiratory abnormality, unspecified
786.05......................................  Shortness of breath
786.2.......................................  Cough
786.3.......................................  Hemoptysis
786.4.......................................  Abnormal sputum
787.91......................................  Diarrhea
795.71......................................  Nonspecific serologic evidence of human immunodefiency virus
799.4.......................................  Wasting disease
V01.7.......................................  Contact with or exposure to communicable diseases, other viral
                                               diseases
V71.5.......................................  Rape
----------------------------------------------------------------------------------------------------------------

Reasons for Denial

    Note: This section was not negotiated by the Negotiated 
Rulemaking Committee. This section includes HCFA's interpretation of 
its longstanding policies and is included for informational 
purposes.


     Tests for screening purposes that are performed in the 
absence of signs, symptoms, complaints, or personal history of disease 
or injury are not covered except as explicitly authorized by statute. 
These include exams required by insurance companies, business 
establishments, government agencies, or other third parties.
     Tests that are not reasonable and necessary for the 
diagnosis or treatment of an illness or injury are not covered 
according to the statute.
     Failure to provide documentation of the medical necessity 
of tests may result in denial of claims. Such documentation may include 
notes documenting relevant signs, symptoms or abnormal findings that 
substantiate the medical necessity for ordering the tests. In addition, 
failure to provide independent verification that the test was ordered 
by the treating physician (or qualified nonphysician practitioner) 
through documentation in the physician's office may result in denial.
     A claim for a test for which there is a national coverage 
or local medical review policy will be denied as not reasonable and 
necessary if it is submitted without an ICD-9-CM code or narrative 
diagnosis listed as covered in the policy unless other medical 
documentation justifying the necessity is submitted with the claim.
     If a national or local policy identifies a frequency 
expectation, a claim for a test that exceeds that expectation may be 
denied as not reasonable and necessary, unless it is submitted with 
documentation justifying increased frequency.
     Tests that are not ordered by a treating physician or 
other qualified treating nonphysician practitioner acting within the 
scope of their license and in compliance with Medicare requirements 
will be denied as not reasonable and necessary.
     Failure of the laboratory performing the test to have the 
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
certificate for the testing performed will result in denial of claims.

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs
V16.5.......................................  Family history of malignant neoplasm, urinary organs
V16.6.......................................  Family history of malignant neoplasm, leukemia
V16.7.......................................  Family history of malignant neoplasm, other lymphatic and
                                               hematopoietic neoplasms
V16.8.......................................  Family history of malignant neoplasm, other specified malignant
                                               neoplasm
V16.9.......................................  Family history of malignant neoplasm, unspecified malignant
                                               neoplasm
V17.0-V17.8.................................  Family history of certain chronic disabling diseases

[[Page 58821]]


V18.0-V18.8.................................  Family history of certain other specific conditions
V19.0-V19.8.................................  Family history of other conditions
V20.0-V20.2.................................  Health supervision of infant or child
V28.0-V28.9.................................  Antenatal screenings
V50.0-V50.9.................................  Elective surgery for purposes other than remedying health states
V53.2.......................................  Fitting and adjustment of hearing aid
V60.0-V60.9.................................  Housing, household, and economic circumstances
V62.0.......................................  Unemployment
V62.1.......................................  Adverse effects of work environment
V65.0.......................................  Healthy persons accompanying sick persons
V65.1.......................................  Persons consulting on behalf of another person
V68.0-V68.9.................................  Encounters for administrative purposes
V70.0-V70.9.................................  General medical examinations
V73.0-V73.99................................  Special screening examinations for viral and chlamydia diseases
V74.0-V74.9.................................  Special screening examinations for bacterial and spirochetal
                                               diseases
V75.0-V75.9.................................  Special screening examination for other infectious diseases
V76.0.......................................  Special screening for malignant neoplasms, respiratory organs
V76.3.......................................  Special screening for malignant neoplasms, bladder
V76.42-V76.9................................  Special screening for malignant neoplasms, (sites other than
                                               breast, cervix, and rectum)
V77.0-V77.9.................................  Special screening for endocrine, nutrition, metabolic, and
                                               immunity disorders
V78.0-V78.9.................................  Special Screening for disorders of blood and blood-forming organs
V79.0-V79.9.................................  Special screening for mental disorders
V80.0-V80.3.................................  Special screening for neurological, eye, and ear diseases
V81.0-V81.6.................................  Special screening for cardiovascular, respiratory, and
                                               genitourinary diseases
V82.0-V82.9.................................  Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

    Any ICD-9-CM code not listed in either of the ICD-9-CM sections 
above.

Sources of Information

    CDC, 1993. Revised classification system for HIV infection and 
expanded surveillance case definition for AIDS among adolescents and 
adults. MMWR 41 (No. RR17).
    CDC, 1994. Revised classification system for human immunodeficiency 
virus infection in children less than 13 years of age.
    CDC, 1998. Guidelines for treatment of sexually transmitted 
diseases. MMWR 47 (RR1):11-17.
    Piatak, M., M.S. Saag, L.C. Yang, et al. 1993. High levels of HIV-1 
in plasma during all stages of infection determined by competitive PCR. 
Science 259:1749-1754.
    Rhame, R.S. 1994. Acquired immunodeficiency syndrome, p. 628-652. 
In Infectious Diseases; P.D. Hoeprich, M.C. Jordan, and A.R. Ronald 
(J.B. Lippincott Co., Philadelphia).
    Vasudevachari, M.D., R.T. Davey, Jr., J.A. Metcalf, and H.C. Lane. 
1997. Principles and procedures of human immunodeficiency virus 
serodiagnosis. In Manual of Clinical Laboratory Immunology (Fifth ed.); 
N.R. Rose, E.C. de Macario, J.D. Folds, H.C. Lane, and R.M. Nakamura 
(ASM Press, Washington, DC).

Coding Guidelines

    1. Any claim for a test listed in ``HCPCS CODES'' above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
Codes that describe symptoms and signs, as opposed to diagnoses, should 
be provided for reporting purposes when a diagnosis has not been 
established by the physician. (Based on Coding Clinic for ICD-9-CM, 
Fourth Quarter 1995, page 43.)
    2. Screening is the testing for disease or disease precursors so 
that early detection and treatment can be provided for those who test 
positive for the disease. Screening tests are performed when no 
specific sign, symptom, or diagnosis is present and the patient has not 
been exposed to a disease. The testing of a person to rule out or to 
confirm a suspected diagnosis because the patient has a sign and/or 
symptom is a diagnostic test, not a screening. In these cases, the sign 
or symptom should be used to explain the reason for the test. When the 
reason for performing a test is because the patient has had contact 
with, or exposure to, a communicable disease, the appropriate code from 
category V01, Contact with or exposure to communicable diseases, should 
be assigned, not a screening code, but the test may still be considered 
screening and not covered by Medicare. For screening tests, the 
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or 
comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, 
Fourth Quarter 1996, pages 50 and 52.)
    3. A three-digit code is to be used only if it is not further 
subdivided. Where fourth-digit and/or fifth-digit subclassifications 
are provided, they must be assigned. A code is invalid if it has not 
been coded to the full number of digits required for that code. (From 
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)
    4. Diagnoses documented as ``probable,'' ``suspected,'' 
``questionable,'' ``rule-out,'' or ``working diagnosis'' should not be 
coded as though they exist. Rather, code the condition(s) to the 
highest degree of certainty for that encounter/visit, such as signs, 
symptoms, abnormal test results, exposure to communicable disease or 
other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth 
Quarter 1995, page 45.)
    5. When a non-specific ICD-9 code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for the 
test above.
    6. Specific coding guidelines:
    a. CPT 86701 or 86703 is performed initially. CPT 86702 is 
performed when 86701 is negative and clinical suspicion of HIV-2 
exists.
    b. CPT 86689 is performed only on samples repeatedly positive by 
86701, 86702, or 86703.
    c. CPT 87534 or 87535 is used to detect HIV-1 RNA where indicated. 
CPT 87537 or 87538 is used to detect HIV-2 RNA where indicated.

Documentation Requirements

    Appropriate HCPCS/CPT codes must be used as described.
Medicare National Coverage Decision: Blood Counts
Other Names/Abbreviations: CBC

[[Page 58822]]

Description

    Blood counts are used to evaluate and diagnose diseases relating to 
abnormalities of the blood or bone marrow. These include primary 
disorders such as anemia, leukemia, polycythemia, thrombocytosis and 
thrombocytopenia. Many other conditions secondarily affect the blood or 
bone marrow, including reaction to inflammation and infections, 
coagulopathies, neoplasms and exposure to toxic substances. Many 
treatments and therapies affect the blood or bone marrow, and blood 
counts may be used to monitor treatment effects.
    The complete blood count (CBC) includes a hemogram and differential 
white blood count (WBC). The hemogram includes enumeration of red blood 
cells, white blood cells, and platelets, as well as the determination 
of hemoglobin, hematocrit, and indices.
    The symptoms of hematological disorders are often nonspecific, and 
are commonly encountered in patients who may or may not prove to have a 
disorder of the blood or bone marrow. Furthermore, many medical 
conditions that are not primarily due to abnormalities of blood or bone 
marrow may have hematological manifestations that result from the 
disease or its treatment. As a result, the CBC is one of the most 
commonly indicated laboratory tests.
    In patients with possible hematological abnormalities, it may be 
necessary to determine the hemoglobin and hematocrit, to calculate the 
red cell indices, and to measure the concentration of white blood cells 
and platelets. These measurements are usually performed on a 
multichannel analyzer that measures all of the parameters on every 
sample. Therefore, laboratory assessments routinely include these 
measurements.

HCPCS Codes (alpha numeric, CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
85007.......................................  Blood count; manual differential WBC count (includes RBC
                                               morphology and platelet estimation)
85008.......................................  Blood counts, manual blood smear examination without differential
                                               parameters
85013.......................................  Blood counts, Spun microhematocrit
85014.......................................  Blood counts, Other than spun hematocrit
85018.......................................  Blood counts, Hemoglobin
85021.......................................  Blood counts, Hemogram, automated (RBC, WBC, Hgb, Hct, and indices
                                               only)
85022.......................................  Blood counts, Hemogram, automated, and manual differential WBC
                                               count (CBC)
85023.......................................  Blood counts, Hemogram and platelet count, automated, and manual
                                               differential WBC count (CBC)
85024.......................................  Blood counts, Hemogram and platelet count, automated, and
                                               automated partial differential WBC count (CBC)
85025.......................................  Hemogram and platelet count, automated and automated complete
                                               differential WBC count (CBC)
85027.......................................  Blood counts, Hemogram and platelet count, automated
85031.......................................  Blood count; hemogram, manual, complete CBC (RBC, Hgb, Hct,
                                               differential and indices
85048.......................................  Blood counts, White blood cell (WBC)
85590.......................................  Platelet; manual count
85595.......................................  Platelet, automated count
----------------------------------------------------------------------------------------------------------------

Indications

    Indications for a CBC or hemogram include red cell, platelet, and 
white cell disorders. Examples of these indications are enumerated 
individually below.
    1. Indications for a CBC generally include the evaluation of bone 
marrow dysfunction as a result of neoplasms, therapeutic agents, 
exposure to toxic substances, or pregnancy. The CBC is also useful in 
assessing peripheral destruction of blood cells, suspected bone marrow 
failure or bone marrow infiltrate, suspected myeloproliferative, 
myelodysplastic, or lymphoproliferative processes, and immune 
disorders.
    2. Indications for hemogram or CBC related to red cell (RBC) 
parameters of the hemogram include signs, symptoms, test results, 
illness, or disease that can be associated with anemia or other red 
blood cell disorder (e.g., pallor, weakness, fatigue, weight loss, 
bleeding, acute injury associated with blood loss or suspected blood 
loss, abnormal menstrual bleeding, hematuria, hematemesis, 
hematochezia, positive fecal occult blood test, malnutrition, vitamin 
deficiency, malabsorption, neuropathy, known malignancy, presence of 
acute or chronic disease that may have associated anemia, coagulation 
or hemostatic disorders, postural dizziness, syncope, abdominal pain, 
change in bowel habits, chronic marrow hypoplasia or decreased RBC 
production, tachycardia, systolic heart murmur, congestive heart 
failure, dyspnea, angina, nailbed deformities, growth retardation, 
jaundice, hepatomegaly, splenomegaly, lymphadenopathy, ulcers on the 
lower extremities).
    3. Indications for hemogram or CBC related to red cell (RBC) 
parameters of the hemogram include signs, symptoms, test results, 
illness, or disease that can be associated with polycythemia (for 
example, fever, chills, ruddy skin, conjunctival redness, cough, 
wheezing, cyanosis, clubbing of the fingers, orthopnea, heart murmur, 
headache, vague cognitive changes including memory changes, sleep 
apnea, weakness, pruritus, dizziness, excessive sweating, visual 
symptoms, weight loss, massive obesity, gastrointestinal bleeding, 
paresthesias, dyspnea, joint symptoms, epigastric distress, pain and 
erythema of the fingers or toes, venous or arterial thrombosis, 
thromboembolism, myocardial infarction, stroke, transient ischemic 
attacks, congenital heart disease, chronic obstructive pulmonary 
disease, increased erythropoetin production associated with neoplastic, 
renal or hepatic disorders, androgen or diuretic use, splenomegaly, 
hepatomegaly, diastolic hypertension.)
    4. Specific indications for CBC with differential count related to 
the WBC include signs, symptoms, test results, illness, or disease 
associated with leukemia, infections or inflammatory processes, 
suspected bone marrow failure or bone marrow infiltrate, suspected 
myeloproliferative, myelodysplastic or lymphoproliferative disorder, 
use of drugs that may cause leukopenia, and immune disorders (e.g., 
fever, chills, sweats, shock, fatigue, malaise, tachycardia, tachypnea, 
heart

[[Page 58823]]

murmur, seizures, alterations of consciousness, meningismus, pain such 
as headache, abdominal pain, arthralgia, odynophagia, or dysuria, 
redness or swelling of skin, soft tissue bone, or joint, ulcers of the 
skin or mucous membranes, gangrene, mucous membrane discharge, 
bleeding, thrombosis, respiratory failure, pulmonary infiltrate, 
jaundice, diarrhea, vomiting, hepatomegaly, splenomegaly, 
lymphadenopathy, opportunistic infection such as oral candidiasis.)
    5. Specific indications for CBC related to the platelet count 
include signs, symptoms, test results, illness, or disease associated 
with increased or decreased platelet production and destruction, or 
platelet dysfunction (e.g., gastrointestinal bleeding, genitourinary 
tract bleeding, bilateral epistaxis, thrombosis, ecchymosis, purpura, 
jaundice, petechiae, fever, heparin therapy, suspected DIC, shock, pre-
eclampsia, neonate with maternal ITP, massive transfusion, recent 
platelet transfusion, cardiopulmonary bypass, hemolytic uremic 
syndrome, renal diseases, lymphadenopathy, hepatomegaly, splenomegaly, 
hypersplenism, neurologic abnormalities, viral or other infection, 
myeloproliferative, myelodysplastic, or lymphoproliferative disorder, 
thrombosis, exposure to toxic agents, excessive alcohol ingestion, 
autoimmune disorders (SLE, RA and other).
    6. Indications for hemogram or CBC related to red cell (RBC) 
parameters of the hemogram include, in addition to those already 
listed, thalassemia, suspected hemoglobinopathy, lead poisoning, 
arsenic poisoning, and spherocytosis.
    7. Specific indications for CBC with differential count related to 
the WBC include, in addition to those already listed, storage diseases/
mucopolysaccharidoses, and use of drugs that cause leukocytosis such as 
G-CSF or GM-CSF.
    8. Specific indications for CBC related to platelet count include, 
in addition to those already listed, May-Hegglin syndrome and Wiskott-
Aldrich syndrome.

Limitations

    1. Testing of patients who are asymptomatic, or who do not have a 
condition that could be expected to result in a hematological 
abnormality, is screening and is not a covered service.
    2. In some circumstances it may be appropriate to perform only a 
hemoglobin or hematocrit to assess the oxygen carrying capacity of the 
blood. When the ordering provider requests only a hemoglobin or 
hematocrit, the remaining components of the CBC are not covered.
    3. When a blood count is performed for an end-stage renal disease 
(ESRD) patient, and is billed outside the ESRD rate, documentation of 
the medical necessity for the blood count must be submitted with the 
claim.
    4. In some patients presenting with certain signs, symptoms or 
diseases, a single CBC may be appropriate. Repeat testing may not be 
indicated unless abnormal results are found, or unless there is a 
change in clinical condition. If repeat testing is performed, a more 
descriptive diagnosis code (e.g., anemia) should be reported to support 
medical necessity. However, repeat testing may be indicated where 
results are normal in patients with conditions where there is a 
continued risk for the development of hematologic abnormality.

ICD-9-CM Codes Covered by Medicare Program

    Any ICD-9-CM code not listed in either of the ICD-9-CM code 
sections below.

Reasons for Denial

    [Note: This section was not negotiated by the Negotiated 
Rulemaking Committee. This section includes HCFA's interpretation of 
its longstanding policies and is included for informational 
purposes.]


     Tests for screening purposes that are performed in the 
absence of signs, symptoms, complaints, or personal history of disease 
or injury are not covered except as explicitly authorized by statute. 
These include exams required by insurance companies, business 
establishments, government agencies, or other third parties.
     Tests that are not reasonable and necessary for the 
diagnosis or treatment of an illness or injury are not covered 
according to the statute.
     Failure to provide documentation of the medical necessity 
of tests may result in denial of claims. Such documentation may include 
notes documenting relevant signs, symptoms or abnormal findings that 
substantiate the medical necessity for ordering the tests. In addition, 
failure to provide independent verification that the test was ordered 
by the treating physician (or qualified nonphysician practitioner) 
through documentation in the physician's office may result in denial.
     A claim for a test for which there is a national coverage 
or local medical review policy will be denied as not reasonable and 
necessary if it is submitted without an ICD-9-CM code or narrative 
diagnosis listed as covered in the policy unless other medical 
documentation justifying the necessity is submitted with the claim.
     If a national or local policy identifies a frequency 
expectation, a claim for a test that exceeds that expectation may be 
denied as not reasonable and necessary, unless it is submitted with 
documentation justifying increased frequency.
     Tests that are not ordered by a treating physician or 
other qualified treating nonphysician practitioner acting within the 
scope of their license and in compliance with Medicare requirements 
will be denied as not reasonable and necessary.
     Failure of the laboratory performing the test to have the 
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
certificate for the testing performed will result in denial of claims.

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs
V16.5.......................................  Family history of malignant neoplasm, urinary organs
V16.6.......................................  Family history of malignant neoplasm, leukemia
V16.7.......................................  Family history of malignant neoplasm, other lymphatic and
                                               hematopoietic neoplasms
V16.8.......................................  Family history of malignant neoplasm, other specified malignant
                                               neoplasm
V16.9.......................................  Family history of malignant neoplasm, unspecified malignant
                                               neoplasm
V17.0-V17.8.................................  Family history of certain chronic disabling diseases

[[Page 58824]]


V18.0-V18.8.................................  Family history of certain other specific conditions
V19.0-V19.8.................................  Family history of other conditions
V20.0-V20.2.................................  Health supervision of infant or child
V28.0-V28.9.................................  Antenatal screenings
V50.0-V50.9.................................  Elective surgery for purposes other than remedying health states
V53.2.......................................  Fitting and adjustment of hearing aid
V60.0-V60.9.................................  Housing, household, and economic circumstances
V62.0.......................................  Unemployment
V62.1.......................................  Adverse effects of work environment
V65.0.......................................  Healthy persons accompanying sick persons
V65.1.......................................  Persons consulting on behalf of another person
V68.0-V68.9.................................  Encounters for administrative purposes
V70.0-V70.9.................................  General medical examinations
V73.0-V73.99................................  Special screening examinations for viral and chlamydia diseases
V74.0-V74.9.................................  Special screening examinations for bacterial and spirochetal
                                               diseases
V75.0-V75.9.................................  Special screening examination for other infectious diseases
V76.0.......................................  Special screening for malignant neoplasms, respiratory organs
V76.3.......................................  Special screening for malignant neoplasms, bladder
V76.42-V76.9................................  Special screening for malignant neoplasms, (sites other than
                                               breast, cervix, and rectum)
V77.0-V77.9.................................  Special screening for endocrine, nutrition, metabolic, and
                                               immunity disorders
V78.0-V78.9.................................  Special screening for disorders of blood and blood-forming organs
V79.0-V.79.9................................  Special screening for mental disorders
V80.0-V80.3.................................  Special screening for neurological, eye, and ear diseases
V81.0-V81.6.................................  Special screening for cardiovascular, respiratory, and
                                               genitourinary diseases
V82.0-V82.9.................................  Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
078.10-078.19...............................  Viral warts
210.0-210.9.................................  Benign neoplasm of lip, oral cavity, and pharynx
214.0.......................................  Lipoma, skin and subcutaneous tissue of face
216.0-216.9.................................  Benign neoplasm of skin
217.........................................  Benign neoplasm of breast
222.0-222.9.................................  Benign neoplasm of male genital organs
224.0.......................................  Benign neoplasm of eye
230.0.......................................  Carcinoma in situ of lip, oral cavity and pharynx
232.0-232.9.................................  Carcinoma in situ of skin
300.00-300.09...............................  Neurotic disorders
301.0-301.9.................................  Personality disorders
302.0-302.9.................................  Sexual deviations and disorders
307.0.......................................  Stammering and stuttering
307.20-307.23...............................  Tics
307.3.......................................  Stereotyped repetitive movements
307.80-307.89...............................  Psychalgia
312.00-312.9................................  Disturbance of conduct, not elsewhere classified
313.0-313.9.................................  Disturbance of emotions specific to childhood and adolescence
314.00-314.9................................  Hyperkinetic syndrome of childhood
363.30-363.35...............................  Chorioretinal scars
363.40-363.43...............................  Choroidal degeneration
363.50-363.57...............................  Hereditary choroidal dystrophies
363.70-363.9................................  Choroidal detachment
366.00-366.9................................  Cataract
367.0-367.9.................................  Disorders of refraction and accommodation
371.00-371.9................................  Corneal opacity and other disorders of cornea
373.00-373.9................................  Inflammation of eyelids
375.00-375.9................................  Disorders of lacrimal system
376.21-376.9................................  Disorders of the orbit, except 376.3 Other exophthalmic conditions
377.10-377.16...............................  Optic atrophy
377.21-377.24...............................  Other disorders of optic disc
384.20-384.25...............................  Perforation of tympanic membrane
384.81-384.82...............................  Other specified disorders of tympanic membrane
385.00-385.90...............................  Other disorders of middle ear and mastoid
387.0-387.9.................................  Otosclerosis
388.00-388.5................................  Other disorders of ear
389.00-389.9................................  Hearing loss
440.0-440.1.................................  Atherosclerosis of aorta and renal artery
443.8-443.9.................................  Peripheral vascular disease
448.1.......................................  Capillary nevus, non neoplastic
457.0.......................................  Postmastectomy lymphedema syndrome
470.........................................  Deviated nasal septum
471.0-471.9.................................  Nasal polyps
478.0.......................................  Hypertrophy of nasal turbinates

[[Page 58825]]


478.4.......................................  Polyp of vocal cord or larynx
520.0-520.9.................................  Disorders of tooth development and eruption
521.0-521.9.................................  Diseases of hard tissues of teeth
524.00-524.9................................  Dentofacial anomalies, including malocclusion
525.0-525.9.................................  Other diseases and conditions of teeth and supporting structures
526.0-526.3.................................  Diseases of the jaws
527.6-527.9.................................  Diseases of the salivary glands
575.6.......................................  Cholesterolosis of gallbladder
600.........................................  Hyperplasia of prostate
603.0.......................................  Encysted hydrocele
603.8.......................................  Other specified types of hydrocele
603.9.......................................  Hydrocele, unspecified
605.........................................  Redundant prepuce and phimosis
606.0-606.1.................................  Infertility, male
608.1.......................................  Spermatocoele
608.3.......................................  Atrophy of testis
610.0-610.9.................................  Benign mammary dysplasia
611.1-611.6.................................  Other disorders of breast
611.9.......................................  Unspecified breast disorder
616.2.......................................  Cyst of Bartholin's gland
618.0-618.9.................................  Genital prolapse
620.0-620.3.................................  Noninflammatory disorders of ovary, fallopian tube, and broad
                                               ligament
621.6-621.7.................................  Malposition or inversion of uterus
627.2-627.9.................................  Menopausal and post menopausal disorders
628.0-628.9.................................  Infertility, female
676.00-676.94...............................  Other disorders of breast associated with childbirth and disorders
                                               of lactation
691.0-691.8.................................  Atopic dermatitis and related disorders
692.0-692.9.................................  Contact dermatitis and other eczema
700.........................................  Corns and callosities
701.0-701.9.................................  Other hypertrophic and atrophic conditions of skin
702.0-702.8.................................  Other dermatoses
703.9.......................................  Unspecified disease of nail
706.0-706.9.................................  Diseases of sebaceous glands
709.00-709.4................................  Other disorders of skin and subcutaneous tissue
715.00-715.98...............................  Osteoarthrosis
716.00-716.99...............................  Other and unspecified arthropathies
718.00-718.99...............................  Other derangement of joint
726.0-726.91................................  Peripheral esthesiopathies and allied syndromes
727.00-727.9................................  Other disorders of synovium, tendon, and bursa
728.10-728.85...............................  Disorders of muscle ligament and fascia
732.0-732.9.................................  Osteochondropathies
733.00-733.09...............................  Osteoporosis
734.........................................  Flat foot
735.0-735.9.................................  Acquired deformities of toe
736.00-736.9................................  Other acquired deformities of limb
737.0-737.9.................................  Curvature of spine
738.0-738.9.................................  Other acquired deformity
739.0-739.9.................................  Nonallopathic lesions, not elsewhere classified
830.0-839.9.................................  Dislocations
840.0-848.9.................................  Sprains and strains
905.0-909.9.................................  Late effects of musculoskeletal and connective tissue injuries
910.0-919.9.................................  Superficial injuries
930.0-932...................................  Foreign body on external eye, in ear, in nose
955.0-957.9.................................  Injury to peripheral nerve
V03.0-V06.9.................................  Need for prophylactic vaccination
V11.0-V11.9.................................  Personal history of mental disorder
V14.0-V14.8.................................  Personal history of allergy to medicinal agents
V16.0.......................................  Family history of malignant neoplasm, gastrointestinal tract
V16.3.......................................  Family history of malignant neoplasm, breast
V21.0-V21.9.................................  Constitutional states in development
V25.01-V25.9................................  Encounter for contraceptive management
V26.0-V26.9.................................  Procreative management
V40.0-V40.9.................................  Mental and behavioral problems
V41.0-V41.9.................................  Problems with special senses and other special functions
V43.0-V43.1.................................  Organ or tissue replaced by other means, eye globe or lens
V44.0-V44.9.................................  Artificial opening status
V45.00-V45.89...............................  Other post surgical states
V48.0-V48.9.................................  Problems with head, neck, and trunk
V49.0-V49.9.................................  Problems with limbs
V51.........................................  Aftercare involving the use of plastic surgery
V52.0-V52.9.................................  Fitting and adjustment of prosthetic device and implant
V53.01-V53.09...............................  Fitting and adjustment of devices related to nervous system and
                                               special senses
V53.1.......................................  Fitting and adjustment of spectacles and contact lenses
V53.31-V53.39...............................  Fitting and adjustment of cardiac device

[[Page 58826]]


V53.4.......................................  Fitting and adjustment of orthodontic devices
V53.5.......................................  Fitting and adjustment of other intestinal appliance
V53.6.......................................  Fitting and adjustment of urinary devices
V53.7.......................................  Fitting and adjustment of orthopedic devices
V53.8.......................................  Fitting and adjustment of wheelchair
V53.9.......................................  Fitting and adjustment of other and unspecified device
V54.0-V54.9.................................  Other orthopedic aftercare
V55.0-V55.9.................................  Attention to artificial openings
V57.0-V57.9.................................  Care involving use of rehabilitation procedures
V58.5.......................................  Orthodontics
V59.0-V59.9.................................  Donors
V61.0-V61.9.................................  Other family circumstances
V62.2-V62.9.................................  Other psychosocial circumstances
V65.2.......................................  Person feigning illness
V65.3.......................................  Dietary surveillance and counseling
V65.40-V65.49...............................  Other counseling, not elsewhere classified
V65.5.......................................  Person with feared complaint in whom no diagnosis was made
V65.8.......................................  Other reasons for seeking consultation
V65.9.......................................  Unspecified reason for consultation
V66.0-V66.9.................................  Convalescence and palliative care
V67.3.......................................  Follow-up examination following psychotherapy
V67.4.......................................  Follow-up examination following treatment of healed fracture
V69.3.......................................  Problems related to lifestyle, gambling and betting
V71.01-V71.09...............................  Observation and evaluation for suspected conditions not found,
                                               mental
V72.0-V72.2.................................  Special investigations, examination of eyes and vision, ears and
                                               hearing, dental
V72.4-V72.7.................................  Special investigations, radiologic exam, laboratory exam,
                                               diagnostic skin and sensitization tests
V72.9.......................................  Special investigation, unspecified
V76.10-V76.19...............................  Special screening for malignant neoplasms, breast
V76.2.......................................  Special screening for malignant neoplasms, cervix
----------------------------------------------------------------------------------------------------------------

Sources of Information

    Wintrobe's Clinical Hematology, G. Richard Lee et al editors, Lea & 
Febiger, 9th edition, Philadelphia PA 1993.
    Hematology, Clinical and Laboratory Practice, R. Bick et al 
editors, Mosby-Year Book, Inc., St. Louis, Missouri, 1993.
    ``The Polycythemias'', V. C. Broudy, Medicine, Chapter 5.V. 
Scientific American, New York, NY 1996.
    Laboratory Test Handbook, D.S. Jacobs et al, Lexi-Comp Inc, 4th 
edition, Cleveland OH 1996.
    Cancer: Principals & Practice of Oncology, DeVita, et al., 5th 
edition, Philadelphia: Lippincott-Raven, 1997.
    Cecil Textbook of Medicine, Bennett, et al., 20th edition, 
Philadelphia: W.B. Saunders, 1996.
    Williams Hematology, Beutler, et al., 5th edition, New York: 
McGraw-Hill, 1995.

Coding Guidelines

    1. Any claim for a test listed in ``HCPCS CODES'' above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
Codes that describe symptoms and signs, as opposed to diagnoses, should 
be provided for reporting purposes when a diagnosis has not been 
established by the physician. (Based on Coding Clinic for ICD-9-CM, 
Fourth Quarter 1995, page 43.)
    2. Screening is the testing for disease or disease precursors so 
that early detection and treatment can be provided for those who test 
positive for the disease. Screening tests are performed when no 
specific sign, symptom, or diagnosis is present and the patient has not 
been exposed to a disease. The testing of a person to rule out or to 
confirm a suspected diagnosis because the patient has a sign and/or 
symptom is a diagnostic test, not a screening. In these cases, the sign 
or symptom should be used to explain the reason for the test. When the 
reason for performing a test is because the patient has had contact 
with, or exposure to, a communicable disease, the appropriate code from 
category V01, Contact with or exposure to communicable diseases, should 
be assigned, not a screening code, but the test may still be considered 
screening and not covered by Medicare. For screening tests, the 
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or 
comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, 
Fourth Quarter 1996, pages 50 and 52.)
    3. A three-digit code is to be used only if it is not further 
subdivided. Where fourth-digit and/or fifth-digit subclassifications 
are provided, they must be assigned. A code is invalid if it has not 
been coded to the full number of digits required for that code. (From 
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)
    4. Diagnoses documented as ``probable,'' ``suspected,'' 
``questionable,'' ``rule-out,'' or ``working diagnosis'' should not be 
coded as though they exist. Rather, code the condition(s) to the 
highest degree of certainty for that encounter/visit, such as signs, 
symptoms, abnormal test results, exposure to communicable disease or 
other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth 
Quarter 1995, page 45.)
    5. When a non-specific ICD-9-CM code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for the 
test above.

Medicare National Coverage Decision for Partial Thromboplastin Time

Other Names/Abbreviations: PTT

Description

    Basic plasma coagulation function is readily assessed with a few 
simple laboratory tests: The partial thromboplastin time (PTT), 
prothrombin time (PT), thrombin time (TT), or a quantitative fibrinogen 
determination. The partial thromboplastin time (PTT) test is an in 
vitro laboratory test used to assess the intrinsic coagulation pathway 
and monitor heparin therapy.

[[Page 58827]]

HCPCS Codes (alpha numeric, CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
85730.......................................  Thromboplastin time, partial (PTT); plasma or whole blood
----------------------------------------------------------------------------------------------------------------

Indications

    1. The PTT is most commonly used to quantitate the effect of 
therapeutic unfractionated heparin and to regulate its dosing. Except 
during transitions between heparin and warfarin therapy, in general 
both the PTT and PT are not necessary together to assess the effect of 
anticoagulation therapy. PT and PTT must be justified separately. (See 
``Limitations'' section for further discussion.)
    2. A PTT may be used to assess patients with signs or symptoms of 
hemorrhage or thrombosis. For example:

abnormal bleeding, hemorrhage or hematoma petechiae or other signs of 
thrombocytopenia that could be due to Disseminated Intravascular 
Coagulation swollen extremity with or without prior trauma
    3. A PTT may be useful in evaluating patients who have a history of 
a condition known to be associated with the risk of hemorrhage or 
thrombosis that is related to the intrinsic coagulation pathway. Such 
abnormalities may be genetic or acquired. For example:

dysfibrinogenemia
afibrinogenemia (complete)
acute or chronic liver dysfunction or failure, including
Wilson's disease
hemophilia
liver disease and failure
infectious processes
bleeding disorders
disseminated intravascular coagulation
lupus erythematosus or other conditions associated with circulating 
inhibitors, e.g., Factor VIII Inhibitor, lupus-like anticoagulant, etc.
sepsis
von Willebrand's disease
arterial and venous thrombosis, including the evaluation of 
hypercoagulable states
clinical conditions associated with nephrosis or renal failure
other acquired and congenital coagulopathies as well as thrombotic 
states.

    4. A PTT may be used to assess the risk of thrombosis or hemorrhage 
in patients who are going to have a medical intervention known to be 
associated with increased risk of bleeding or thrombosis. An example is 
as follows:

evaluation prior to invasive procedures or operations of patients with 
personal or family history of bleeding or who are on heparin therapy

Limitations

    1. The PTT is not useful in monitoring the effects of warfarin on a 
patient's coagulation routinely. However, a PTT may be ordered on a 
patient being treated with warfarin as heparin therapy is being 
discontinued. (See coding guidelines for instructions on the use of 
code V58.61 in this situation.) A PTT may also be indicated when the PT 
is markedly prolonged due to warfarin toxicity.
    2. The need to repeat this test is determined by changes in the 
underlying medical condition and/or the dosing of heparin.
    3. Testing prior to any medical intervention associated with a risk 
of bleeding and thrombosis (other than thrombolytic therapy) will 
generally be considered medically necessary only where there are signs 
or symptoms of a bleeding or thrombotic abnormality or a personal 
history of bleeding, thrombosis or a condition associated with a 
coagulopathy.
    Hospital/clinic-specific policies, protocols, etc., in and of 
themselves, cannot alone justify coverage.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
02.0-002.9..................................  Typhoid and paratyphoid
03.0-003.9..................................  Other Salmonella infections
038.9.......................................  Unspecified Septicemia
042.........................................  Human immunodeficiency virus (HIV) disease
060.0-060.9.................................  Yellow fever
065.0-065.9.................................  Arthopod borne hemorrhagic fever
070.0-070.9.................................  Viral Hepatitis
075.........................................  Infectious mononucleosis
078.6.......................................  Hemorrhagic nephrosonephritis
078.7.......................................  Arenaviral hemorrhagic fever
120.0.......................................  Schistosomiasis haematobium
121.1.......................................  Clonorchiasis
121.3.......................................  Fascioliasis
124.........................................  Trichinosis
135.........................................  Sarcoidosis
155.0-155.2.................................  Malignant neoplasm of liver and intrahepatic bile ducts
197.7.......................................  Malignant neoplasm of liver, specified as secondary
238.4.......................................  Polycythemia vera
238.7.......................................  Other lymphatic and hemapoietic tissues
239.9.......................................  Neoplasm of unspecified nature, site unspecified
246.3.......................................  Hemorrhage and infarction of thyroid
250.40-250.43...............................  Diabetic with renal manifestations
269.0.......................................  Deficiency of Vitamin K
273.0-273.9.................................  Disorders of plasma protein metabolism
273.2.......................................  Other paraproteinemias
275.0-275.9.................................  Disorders of iron metabolism
277.1.......................................  Disorders of porphyrin metabolism

[[Page 58828]]


277.3.......................................  Amyloidosis
285.1.......................................  Acute posthemorrhagic anemia
286.0.......................................  Congenital factor VIII disorder--Hemophilia A
286.1.......................................  Congenital factor IX disorder--Hemophilia B
286.2-286.3.................................  Other congenital factor deficiencies
286.4.......................................  von Willebrand's disease
286.5.......................................  Hemorrhagic disorder due to circulating anticoagulants
286.6.......................................  Defibrination syndrome
286.7.......................................  Acquired coagulation factor deficiency
286.8-286.9.................................  Other and unspecified coagulation defects
287.0-287.9.................................  Purpura and other hemorrhagic conditions
289.0.......................................  Polycythemia, secondary
325.........................................  Phlebitis and thrombophlebitis of intracranial ventricles sinuses
360.43......................................  Hemophthalmos, except current injury
362.30-362.37...............................  Retinal vasclar occlusion
362.34......................................  Amaurosis fugax
362.43......................................  Hemorrhagic detachmentof retinal pigment epithelium
362.81......................................  Retinal hemorrhage
363.6.......................................  Choroidal hemorrhage
363.72......................................  Choroidal detachment
368.9.......................................  Unspecified Visual Disturbances
372.72......................................  Conjunctive hemorrhage
374.81......................................  Hemorrhage of eyelid
376.32......................................  Orbital hemorrhage
377.42......................................  Hemorrhage in optic nerve sheaths
379.23......................................  Vitreous hemorrhage
380.31......................................  Hematoma of auricle or pinna
403.01, 403.11, 403.91......................  Hypertensive Renal Disease with renal failure
404.02, 404.12, 404.92......................  Hypertensive Heart and Renal Disease with renal failure
410.0-410.9.................................  Acute myocardial infarction
423.0.......................................  Hemopericardium
427.31......................................  Atrial fibrillation
427.9.......................................  Cardiac dysrhythmias, unspecified
428.0.......................................  Congestive heart failure
429.79......................................  Mural thrombus
430-432.9...................................  Cerebral hemorrhage
433.00-433.91...............................  Occlusion and stenosis of precerebral arteries
434.00-434.91...............................  Occlusion of cerebral arteries
435.9.......................................  Focal neurologic deficit
444.0-444.9.................................  Arterial embolism and thrombosis
446.6.......................................  Thrombotic microangiopathy
447.2.......................................  Rupture of artery
448.0.......................................  Hereditary Hemorrhagic telangiectasia
451.0-451.9.................................  Phlebitis and thrombophlebitis
453.0-453.9.................................  Other Venous emboli and thrombosis
456.0.......................................  Esophageal varices with bleeding
456.1.......................................  Esophageal varices without bleeding
456.8.......................................  Varices of other sites
459.89......................................  Ecchymosis
530.7.......................................  Gastroesophageal laceration--hemorrhage syndrome
530.82......................................  Esophgael hemorrhage
531.00-535.61...............................  Gastric-Duodenal ulcer disease
537.83......................................  Angiodysplasia of stomach and duodenum with hemorrhage
556.0-557.9.................................  Hemorrhagic bowel disease
562.02-562.03...............................  Diverticulosis of small intestine with hemorrhage
562.12......................................  Diverticulosis of colon with hemorrhage
562.13......................................  Diverticulitis of colon without hemorrhage
568.81......................................  Hemoperitoneum (nontraumatic)
569.3.......................................  Hemorrhage of rectum and anus
570.........................................  Acute and subacute necrosis of liver
571.0-573.9.................................  Liver disease (in place of specific codes listed)
576.0-576.9.................................  Biliary tract disorders
577.0.......................................  Acute pancreatitis
578.0-578.9.................................  Gastrointestinal Hemorrhage
579.0-579.9.................................  Malabsorption
581.0-581.9.................................  Nephrotic Syndrome
583.9.......................................  Nephritis, with unspecified pathological lesion in kidney
584.5-584.9.................................  Acute Renal Failure
585.........................................  Chronic Renal Failure
586.........................................  Renal failure
593.81-593.89...............................  Other disorders of kidney and ureter, with hemorrhage
596.7.......................................  Hemorrhage into bladder wall
596.8.......................................  Other disorders of bladder, with hemorrhage
599.7.......................................  Hematuria

[[Page 58829]]


607.82......................................  Penile hemorrhage
608.83......................................  Vascular disorders of male genital organs
611.8.......................................  Hematoma of breast
620.7.......................................  Hemorrhage of broad ligament
621.4.......................................  Hematometra
622.8.......................................  Other specified disorders of cervix, with hemorrhage
623.6.......................................  Vaginal hematoma
623.8.......................................  Other specified diseases of the vagina, with hemorrhage
624.5.......................................  Hematoma of vulva
626.6.......................................  Metrorrhagia
626.7.......................................  Postcoital bleeding
627.0.......................................  Premenopausal bleeding
627.1.......................................  Postmenopausal bleeding
629.0.......................................  Hematocele female not elsewhere classified
632.........................................  Missed abortion
634.00-634.92...............................  Spontaneous abortion
635.10-635.12...............................  Legally induced abortion, complicated by delayed or excessive
                                               hemorrhage
636.10-636.12...............................  Illegally induced abortion, complicated by delayed or excessive
                                               hemorrhage
637.10-637.12...............................  Abortion unspecified, complicated by delayed or excessive
                                               hemorrhage
638.1.......................................  Failed attempt abortion, complicated by delayed or excessive
                                               hemorrhage
639.1.......................................  Delayed or excessive hemorrhage following abortion and ectopic and
                                               molar pregnancies
639.6.......................................  Complications following abortion and ectopic and molar
                                               pregnancies, embolism
640.00-640.93...............................  Hemorrhage in early pregnancy
641.00-641.93...............................  Antepartum hemorrhage
642.00-642.94...............................  Hypertension complicating pregnancy, childbirth, and the
                                               puerperium
646.70-646.73...............................  Liver disorders in pregnancy
656.00-656.03...............................  Fetal maternal hemorrhage
658.40-658.43...............................  Infection of amniotic cavity
666.00-666.34...............................  Postpartum hemorrhage
671.20-671.54...............................  Phlebitis in pregnancy
673.00-673.84...............................  Obstetrical pulmonary embolus
674.30-674.34...............................  Other complications of surgical wounds, with hemorrhage
710.0.......................................  Systemic Lupus erythematosus
713.2.......................................  Arthropathy associated with hematologic disorders (note: may not
                                               be used without indicating associated condition first)
713.6.......................................  Arthropathy associated with Henoch Schoenlein (note: may not be
                                               used without indicating associated condition first)
719.10-719.19...............................  Hemarthrosis
729.5.......................................  Leg pain/calf pain
733.1.......................................  Pathologic fracture associated with fat embolism
762.1.......................................  Other forms of placental separation with hemorrhage (affecting
                                               newborn code do not assign to mother's record)
764.90-764.99...............................  Fetal intrauterine growth retardation
767.0-767.1.................................  Subdural and cerebral hemorrhage
767.8.......................................  Other specified birth trauma, with hemorrhage
770.3.......................................  Fetal and newborn pulmonary hemorrhage
772.0-772.9.................................  Fetal and neonatal hemorrhage
774.0-772.7.................................  Other perinatal jaundice
776.0-776.9.................................  Hemorrhagic disease of the newborn
780.2.......................................  Syncope
782.4.......................................  Jaundice, unspecified, not of newborn
782.7.......................................  Spontaneous ecchymoses Petechiae
784.7.......................................  Epistaxis
784.8.......................................  Hemorrhage from throat
785.4.......................................  Gangrene
785.50......................................  Shock
786.05......................................  Shortness of breath
786.3.......................................  Hemoptysis
786.50......................................  Chest pain, unspecified
786.59......................................  Chest pain
789.00-789.09...............................  Abdominal pain
790.92......................................  Abnormal coagulation profile
800.00-800.99...............................  Fracture of vault of skull
801.00-801.99...............................  Fracture of base of skull
802.20-802.9................................  Fracture of face bones
803.00-803.99...............................  Other fracture, skull
804.00-804.99...............................  Multiple fractures, skull
805.00-806.9................................  Fracture, vertebral column
807.00-807.09...............................  Fractures of rib(s), closed
807.10-807.19...............................  Fracture of rib(s), open
808.8-808.9.................................  Fracture of pelvis
809.0-809.1.................................  Fracture of trunk
810.00-810.13...............................  Fracture of clavicle
811.00-811.19...............................  Fracture of scapula

[[Page 58830]]


812.00-812.59...............................  Fracture of humerus
813.10-813.18...............................  Fracture of radius and ulna, upper end, open
813.30-813.38...............................  Fracture of radius and ulna, shaft, open
813.50-813.58...............................  Fracture of radius and ulna, lower end, open
813.90-813.98...............................  Fracture of radius and ulna, unspecified part, open
819.0-819.1.................................  Multiple fractures
820.00-821.39...............................  Femur
823.00-823.92...............................  Tibia and fibula
827.0-829.1.................................  Other multiple lower limb
852.00-853.19...............................  Subarachnoid subdural, and extradural hemorrhage, following
                                               injury, Other and specified intracranial hemorrhage following
                                               injury
860.0-860.5.................................  Traumatic pneumothorax and hemothorax
861.00-861.32...............................  Injury to heart and lung
862.0-862.9.................................  Injury to other and unspecified intrathoracic organs
863.0-863.9.................................  Injury to gastrointestinal tract
864.00-863.19...............................  Injury to liver
865.00-863.19...............................  Injury to spleen
866.00-866.13...............................  Injury to kidney
867.0-867.9.................................  Injury to pelvic organs
868.00-868.19...............................  Injury to other intra-abdominal organs
869.0-869.1.................................  Internal injury to unspecified or ill defined organs
900.00-900.9................................  Injury to blood vessels of head and neck
901.0-901.9.................................  Injury to blood vessels of the thorax
902.0-902.9.................................  Injury to blood vessels of the abdomen and pelvis
903.00-903.9................................  Injury to blood vessels of upper extremity
904.0-904.9.................................  Injury to blood vessels of lower extremity and unspecified sites
920--924.9..................................  Contusion with intact skin surface
925.1-929.9.................................  Crushing injury
958.2.......................................  Secondary and recurrent hemorrhage
959.9.......................................  Injury, unspecified site
964.2.......................................  Poisoning by anticoagulants
964.5.......................................  Poisoning by anticoagulant antagonists
964.7.......................................  Poisoning by natural blood and blood products
980.0.......................................  Toxic effects of alcohol
989.5.......................................  Snake venom
995.2.......................................  Unspecified adverse effect of drug, medicinal and biological
                                               substance (due to correct medicinal substance properly
                                               administered)
996.7.......................................  Other complications of internal prosthetic device
997.02......................................  Iatrogenic cerbrovascular infarction or hemorrhage
998.11......................................  Hemorrhage or hematoma complicating a procedure
999.2.......................................  Other vascular complications of medical care
V12.3.......................................  Personal history of diseases of blood and blood forming organs
V58.2.......................................  Admission for Transfusion of blood products
V58.61......................................  Long term (current use) of anticoagulants
V72.81......................................  Pre-operative cardiovascular examination
V72.83......................................  Other specified pre-operative examination
V72.84......................................  Pre-operative examination, unspecified
----------------------------------------------------------------------------------------------------------------

Reasons for Denial

    Note: This section was not negotiated by the Negotiated 
Rulemaking Committee. This section includes HCFA's interpretation of 
its longstanding policies and is included for informational 
purposes.


     Tests for screening purposes that are performed in the 
absence of signs, symptoms, complaints, or personal history of disease 
or injury are not covered except as explicitly authorized by statute. 
These include exams required by insurance companies, business 
establishments, government agencies, or other third parties.
     Tests that are not reasonable and necessary for the 
diagnosis or treatment of an illness or injury are not covered 
according to the statute.
     Failure to provide documentation of the medical necessity 
of tests may result in denial of claims. Such documentation may include 
notes documenting relevant signs, symptoms or abnormal findings that 
substantiate the medical necessity for ordering the tests. In addition, 
failure to provide independent verification that the test was ordered 
by the treating physician (or qualified nonphysician practitioner) 
through documentation in the physician's office may result in denial.
     A claim for a test for which there is a national coverage 
or local medical review policy will be denied as not reasonable and 
necessary if it is submitted without an ICD-9-CM code or narrative 
diagnosis listed as covered in the policy unless other medical 
documentation justifying the necessity is submitted with the claim.
     If a national or local policy identifies a frequency 
expectation, a claim for a test that exceeds that expectation may be 
denied as not reasonable and necessary, unless it is submitted with 
documentation justifying increased frequency.
     Tests that are not ordered by a treating physician or 
other qualified treating nonphysician practitioner acting within the 
scope of their license and in compliance with Medicare requirements 
will be denied as not reasonable and necessary.
     Failure of the laboratory performing the test to have the 
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA) 
certificate for the testing performed will result in denial of claims.

[[Page 58831]]

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs
V16.5.......................................  Family history of malignant neoplasm, urinary organs
V16.6.......................................  Family history of malignant neoplasm, leukemia
V16.7.......................................  Family history of malignant neoplasm, other lymphatic and
                                               hematopoietic eoplasms
V16.8.......................................  Family history of malignant neoplasm, other specified malignant
                                               neoplasm
V16.9.......................................  Family history of malignant neoplasm, unspecified malignant
                                               neoplasm
V17.0-V17.8.................................  Family history of certain chronic disabling diseases
V18.0-V18.8.................................  Family history of certain other specific conditions
V19.0-V19.8.................................  Family history of other conditions
V20.0-V20.2.................................  Health supervision of infant or child
V28.0-V28.9.................................  Antenatal screenings
V50.0-V50.9.................................  Elective surgery for purposes other than remedying health states
V53.2.......................................  Fitting and adjustment of hearing aid
V60.0-V60.9.................................  Housing, household, and economic circumstances
V62.0.......................................  Unemployment
V62.1.......................................  Adverse effects of work environment
V65.0.......................................  Healthy persons accompanying sick persons
V65.1.......................................  Persons consulting on behalf of another person
V68.0-V68.9.................................  Encounters for administrative purposes
V70.0-V70.9.................................  General medical examinations
V73.0-V73.99................................  Special screening examinations for viral and chlamydia diseases
V74.0-V74.9.................................  Special screening examinations for bacterial and spirochetal
                                               diseases
V75.0-V75.9.................................  Special screening examination for other infectious diseases
V76.0.......................................  Special screening for malignant neoplasms, respiratory organs
V76.3.......................................  Special screening for malignant neoplasms, bladder
V76.42-V76.9................................  Special screening for malignant neoplasms (sites other than
                                               breast, cervix, and rectum)
V77.0-V77.9.................................  Special screening for endocrine, nutrition, metabolic, and
                                               immunity disorders
V78.0-V78.9.................................  Special Screening for disorders of blood and blood-forming organs
V79.0-V.79.9................................  Special screening for mental disorders
V80.0-V80.3.................................  Special screening for neurological, eye, and ear diseases
V81.0-V81.6.................................  Special screening for cardiovascular, respiratory, and
                                               genitourinary diseases
V82.0-V82.9.................................  Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

    Any ICD-9-CM code not listed in either of the ICD-9-CM sections 
above.

Sources of Information

    CMD Clinical Laboratory Workgroup.
    1999 CPT Physicians' Current Procedural Terminology, American 
Medical Association.
    Blue Book of Diagnostic Tests; PL Liu; Saunders.
    Wintrobe's Clinical Hematology; 9th Ed, 1993, Lea and Febiger.
    Harrison's Principles of Internal Medicine, 14th Ed., McGraw Hill, 
1997.
    Disorders of Hemostasis, Ratnoff, Oscar D. and Forbes, Charles D., 
W.B. Saunders Company, 1996.
    Hemostasis and Thrombosis: Basic Principles and Clinical Practice. 
Colman, et al editors, J.B. Lippincott, 3rd Edition, 1994, pp 896-898 
and 1045-1046.
    ``College of American Pathologists Conference XXXI on Laboratory 
Monitoring of Anticoagulant Therapy,'' Arch Pathol Lab Med, Vol 122, 
Sep 1998, pp 782-798.
    Lupus Anticoagulants/Antiphospholipid-protein Antibodies: The Great 
Imposters, Triplett DA, Lupus 1996:5:431

Coding Guidelines

    1. Any claim for a test listed in ``HCPCS CODES'' above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
Codes that describe symptoms and signs, as opposed to diagnoses, should 
be provided for reporting purposes when a diagnosis has not been 
established by the physician. (Based on Coding Clinic for ICD-9-CM, 
Fourth Quarter 1995, page 43.)
    2. Screening is the testing for disease or disease precursors so 
that early detection and treatment can be provided for those who test 
positive for the disease. Screening tests are performed when no 
specific sign, symptom, or diagnosis is present and the patient has not 
been exposed to a disease. The testing of a person to rule out or to 
confirm a suspected diagnosis because the patient has a sign and/or 
symptom is a diagnostic test, not a screening. In these cases, the sign 
or symptom should be used to explain the reason for the test. When the 
reason for performing a test is because the patient has had contact 
with, or exposure to, a communicable disease, the appropriate code from 
category V01, Contact with or exposure to communicable diseases, should 
be assigned, not a screening code, but the test may still be considered 
screening and not covered by Medicare. For screening tests, the 
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or 
comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, 
Fourth Quarter 1996, pages 50 and 52.)
    3. A three-digit code is to be used only if it is not further 
subdivided. Where fourth-digit and/or fifth-digit subclassifications 
are provided, they must be assigned. A code is invalid if it has not 
been coded to the full number of digits required for that code. (From 
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)
    4. Diagnoses documented as ``probable,'' ``suspected,'' 
``questionable,'' ``rule-out,'' or ``working diagnosis'' should not be 
coded as though they exist. Rather, code the

[[Page 58832]]

condition(s) to the highest degree of certainty for that encounter/
visit, such as signs, symptoms, abnormal test results, exposure to 
communicable disease or other reasons for the visit. (From Coding 
Clinic for ICD-9-CM, Fourth Quarter 1995, page 45.)
    5. When a non-specific ICD-9-CM code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for the 
test.
    6. When patients are being converted from heparin therapy to 
warfarin therapy, use code V58.61 to document the medical necessity of 
the PTT.
    7. When coding for Disseminated Intravascular Coagulation (DIC), 
use 286.6 or code for the signs and symptoms clinically indicating DIC.
    8. If a specific condition is known and is the reason for a pre-
operative test, submit the clinical text description or ICD-9-CM code 
describing the condition with the order/referral. If a specific 
condition or disease is not known, and the pre-operative test is for 
pre-operative clearance only, assign code V72.84.
    9. Assign codes 289.8-other specified disease of blood and blood-
forming organs only when a specific disease exists and is indexed to 
289.8, (for example, myelofibrosis). Do not assign code 289.8 to report 
a patient on long term use of anticoagulant therapy (for example, to 
report a PTT value or re-check need for medication adjustment.) Assign 
code V58.61 to referrals for PTT checks or re-checks. (Reference AHA's 
Coding Clinic, March-April, pg 12--1987, 2nd quarter pg 8--1989)

Medicare National Coverage Decision for Prothrombin Time Other
Names/Abbreviations: PT

Description

    Basic plasma coagulation function is readily assessed with a few 
simple laboratory tests: the partial thromboplastin time (PTT), 
prothrombin time (PT), thrombin time (TT), or a quantitative fibrinogen 
determination. The prothrombin time (PT) test is one in-vitro 
laboratory test used to assess coagulation. While the PTT assesses the 
intrinsic limb of the coagulation system, the PT assesses the extrinsic 
or tissue factor dependent pathway. Both tests also evaluate the common 
coagulation pathway involving all the reactions that occur after the 
activation of factor X. Extrinsic pathway factors are produced in the 
liver and their production is dependent on adequate vitamin K activity. 
Deficiencies of factors may be related to decreased production or 
increased consumption of coagulation factors. The PT/INR is most 
commonly used to measure the effect of warfarin and regulate its 
dosing. Warfarin blocks the effect of vitamin K on hepatic production 
of extrinsic pathway factors. A prothrombin time is expressed in 
seconds and/or as an international normalized ratio (INR). The INR is 
the PT ratio that would result if the WHO reference thromboplastin had 
been used in performing the test.
    Current medical information does not clarify the role of laboratory 
PT testing in patients who are self monitoring. Therefore, the 
indications for testing apply regardless of whether or not the patient 
is also PT self-testing.

HCPCS Codes (Alpha numeric CPT  AMA)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
85610.......................................  Prothrombin Time
----------------------------------------------------------------------------------------------------------------

Indications

    1. A PT may be used to assess patients taking warfarin. The 
prothrombin time is generally not useful in monitoring patients 
receiving heparin who are not taking warfarin.
    2. A PT may be used to assess patients with signs or symptoms of 
abnormal bleeding or thrombosis. For example:
     Swollen extremity with or without prior trauma
     Unexplained bruising
     Abnormal bleeding, hemorrhage or hematoma
     Petechiae or other signs of thrombocytopenia that could be 
due to Disseminated Intravascular Coagulation
    3. A PT may be useful in evaluating patients who have a history of 
a condition known to be associated with the risk of bleeding or 
thrombosis that is related to the extrinsic coagulation pathway. Such 
abnormalities may be genetic or acquired. For example:
     Dysfibrinogenemia
     Afibrinogenemia (complete)
     Acute or chronic liver dysfunction or failure, including
     Wilson's disease and Hemochromatosis
     Disseminated intravascular coagulation (DIC)
     Congenital and acquired deficiencies of factors II, V, 
VII, X;
     Vitamin K deficiency
     Lupus erythematosus
     Hypercoagulable state
     Paraproteinemia
     Lymphoma
     Amyloidosis
     Acute and chronic leukemias
     Plasma cell dyscrasia
     HIV infection
     Malignant neoplasms
     Hemorrhagic fever
     Salicylate poisoning
     Obstructive jaundice
     Intestinal fistula
     Malabsorption syndrome
     Colitis
     Chronic diarrhea
     Presence of peripheral venous or arterial thrombosis or 
pulmonary emboli or myocardial infarction
     Patients with bleeding or clotting tendencies
     Organ transplantation
     Presence of circulating coagulation inhibitors
    4. A PT may be used to assess the risk of hemorrhage or thrombosis 
in patients who are going to have a medical intervention known to be 
associated with increased risk of bleeding or thrombosis. For example:
     Evaluation prior to invasive procedures or operations of 
patients with personal history of bleeding or a condition associated 
with coagulopathy.
     Prior to the use of thrombolytic medication

Limitations

    1. When an ESRD patient is tested for PT, testing more frequently 
than weekly (the frequency authorized by 3171.2, Fiscal Intermediary 
Manual, or 2231.3 Medicare Carrier Manual) requires documentation of 
medical necessity [e.g. other than ``Chronic Renal Failure'' (ICD-9-CM 
585) or ``Renal Failure, Unspecified'' (ICD-9-CM 586)].
    2. The need to repeat this test is determined by changes in the 
underlying medical condition and/or the dosing of warfarin. In a 
patient on stable warfarin therapy, it is ordinarily not necessary to 
repeat testing more than every two to three weeks. When testing is 
performed to evaluate a patient with signs or symptoms of abnormal 
bleeding or thrombosis and the initial test result is normal, it is 
ordinarily not necessary to repeat testing unless there is a change in 
the patient's medical status.

[[Page 58833]]

    3. Since the INR is a calculation, it will not be paid in addition 
to the PT when expressed in seconds, and is considered part of the 
conventional prothrombin time, 85610.
    4. Testing prior to any medical intervention associated with a risk 
of bleeding and thrombosis (other than thrombolytic therapy) will 
generally be considered medically necessary only where there are signs 
or symptoms of a bleeding or thrombotic abnormality or a personal 
history of bleeding, thrombosis or a condition associated with a 
coagulopathy.
    Hospital/clinic-specific policies, protocols, etc., in and of 
themselves, cannot alone justify coverage.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
002.0--002.9................................  Typhoid and paratyphoid
003.0--003.9................................  Other Salmonella infections
038.9.......................................  Unspecified Septicemia
042.........................................  Human Immunodeficiency virus (HIV) disease
060.0--060.9................................  Yellow fever
065.0-065.9.................................  Arthropod-borne hemorrhagic fever
070.0-070.9.................................  Viral hepatitis
075.........................................  Infectious mononucleosis
078.6.......................................  Hemorrhagic nephrosonephritis
078.7.......................................  Arenaviral hemorrhagic fever
084.8.......................................  Blackwater fever
120.0.......................................  Schistosomiasis
121.1.......................................  Clonorchiasos
121.3.......................................  Fascioliasis
124.........................................  Trichinosis
134.2.......................................  Hirudiniasis
135.........................................  Sarcoidosis
152.0-152.9.................................  Malignant neoplasm of small intestine, including duodenum
155.0-155.2.................................  Malignant neoplasm of liver and intrahepatic bile ducts
156.0-156.9.................................  Malignant neoplasm of gallbladder and extrahepatic bile ducts
157.0-157.9.................................  Malignant neoplasm of pancreas
188.0-189.9.................................  Malignant neoplasm of bladder, kidney, and other and unspecified
                                               urinary organs
198.0.......................................  Secondary malignant neoplasm, kidney
198.1.......................................  Secondary malignant neoplasm, other urinary organs
200.00-200.88...............................  Lymphosarcoma and reticulosarcoma
202.0-202.98................................  Nodular and other Lymphomas
223.0-223.9.................................  Benign neoplasm of kidney and other urinary organs
238.4.......................................  Polycythemia vera
238.5.......................................  Histocytic and mast cells--neoplasm of uncertain behavior
238.6.......................................  Plasma cells--neoplasm of uncertain behavior
238.7.......................................  Other lymphatic and hematopoietic tissues
239.4.......................................  Neoplasm of unspecified nature, bladder
239.5.......................................  Neoplasm of unspecified nature, other genitourinary organs
239.9.......................................  Neoplasm of unspecified nature, site unspecified
246.3.......................................  Hemorrhage and infarction of thyroid
250.40-250.43...............................  Diabetic with renal manifestations
263.0-263.9.................................  Other and unspecified protein/calorie malnutrition
269.0.......................................  Deficiency of Vitamin K
269.2.......................................  Unspecified vitamin deficiency
273.0-273.9.................................  Disorders of plasma protein metabolism
275.0.......................................  Disorders of iron metabolism
277.1.......................................  Disorders of porphyrin metabolism
277.3.......................................  Amyloidosis
280.0.......................................  Iron deficiency anemia, secondary to blood loss--chronic
280.9.......................................  Iron deficiency anemia, unspecified
281.0.......................................  Pernicious anemia
281.1.......................................  Other Vitamin B12 Deficiency Anemia, NEC
281.9.......................................  Unspecified Deficiency Anemia, NOS
285.0.......................................  Sideroblastic anemia
285.1.......................................  Acute posthemorrhagic anemia
286.0-286.9.................................  Coagulation defects
287.0-287.9.................................  Purpura and other hemorrhagic conditions
290.40-290.43...............................  Arteriosclerotic dementia
325.........................................  Phlebitis and thrombophlebitis of intracranial venous sinuses
342.90-342.92...............................  Hemiplegia NOS
360.43......................................  Hemophthalmios, except current injury
362.18......................................  Retinal vasculitis
362.30-362.37...............................  Retinal vascular occlusion
362.43......................................  Hemorrhagic detachment of retnal pigment epithelium
362.81......................................  Retinal hemorrhage
363.61-363.72...............................  Choroidal hemorrhage and rupture, detachment
368.9.......................................  Unspecified Visual Disturbances
372.72......................................  Conjunctival hemorrhage

[[Page 58834]]


374.81......................................  Hemorrhage of eyelid
376.32......................................  Orbital hemorrhage
377.42......................................  Hemorrhage in optic nerve sheaths
377.53......................................  Disorders of optic chiasm associated with vascular disorders
377.62......................................  Disorders of visual pathways associated with vascular disorders
377.72......................................  Disorders of visual cortex associated with vascular disorders
379.23......................................  Vitreous hemorrhage
380.31......................................  Hematoma of auricle or pinna
386.2.......................................  Vertigo of central origin
386.50......................................  Labyrinthine dysfunction, unspecified
394.0-394.9.................................  Diseases of the mitral valve
395.0.......................................  Rheumatic aortic stenosis
395.2.......................................  Rheumatic aortic stenosis with insufficiency
396.0-396.9.................................  Diseases of mitral and aortic valves
397.0-397.9.................................  Diseases of other endocardial structures
398.0-398.99................................  Other rheumatic heart disease
403.01, 403.11, 403.91......................  Hypertensive Renal Disease with renal failure
404.02, 404.12, 404.92......................  Hypertensive Heart and Renal Disease with renal failure
410.00-410.92...............................  Acute myocardial infarction
411.1.......................................  Intermediate coronary syndrome
411.81......................................  Coronary occlusion without myocardial infarction
411.89......................................  Other acute and subacute forms of ischemic heart disease
413.0-413.9.................................  Angina pectoris
414.00-414.05...............................  Coronary atherosclerosis
414.8.......................................  Other specified forms of chronic ischemic heart disease
414.9.......................................  Chronic ischemic heart disease, unspecified
415.0-415.19................................  Acute pulmonary heart disease
416.9.......................................  Chronic pulmonary heart disease, unspecified
423.0.......................................  Hemopericardium
424.0.......................................  Mitral valve disorders
424.1.......................................  Aortic valve disorder
424.90......................................  Endocarditis, valve unspecified, unspecified cause
425.0-425.9.................................  Cardiomyopathy
427.0-427.9.................................  Cardiac dysrhythmias
1428.0-428.9................................  Heart failure
429.0-429.4.................................  Ill-defined descriptions and complications of heart disease
429.79......................................  Other certain sequelae of myocardial infarction, not elsewhere
                                               classified
430.........................................  Subarachnoid hemorrhage
431.........................................  Intracerebral hemorrhage
432.0-432.9.................................  Other and unspecified intracranial hemorrhage
433.00-433.91...............................  Occlusion and stenosis of precerebral arteries
434.00-434.91...............................  Occlusion of cerebral arteries
435.0-435.9.................................  Transient cerebral ischemia
436.........................................  Acute, but ill-defined cerebrovascular disease
437.0.......................................  Cerebral atherosclerosis
437.1.......................................  Other generalized ischemic cerebrovascular disease
437.6.......................................  Nonpyogenic thrombosis of intracranial venous sinus
440.0-440.9.................................  Atherosclerosis
441.0-441.9.................................  Aortic aneurysm and dissection
443.0-443.9.................................  Other peripheral vascular disease
444.0-444.9.................................  Arterial embolism and thrombosis
447.1.......................................  Stricture of artery
447.2.......................................  Rupture of artery
447.6.......................................  Arteritis, unspecified
448.0.......................................  Hereditary hemorrhagic telangiectasia
448.9.......................................  Other and unspecified capillary diseases
451.0-451.9.................................  Phlebitis and thrombophlebitis
452.........................................  Portal vein thrombosis
453.0-453.9.................................  Other venous embolism and thrombosis
455.2.......................................  Internal hemorrhoids with other complication
455.5.......................................  External hemorrhoids with other complication
455.8.......................................  Unspecified hemorrhoids with other complication
456.0-456.1.................................  Esophageal varices
456.8.......................................  Varices of other sites
459.0.......................................  Hemorrhage, unspecified
459.1.......................................  Postphlebitis syndrome
459.2.......................................  Compression of vein
459.81......................................  Venous (peripheral) insufficiency, unspecified
459.89......................................  Other, other specified disorders of circulatory system
511.8.......................................  Other specified forms of effusion, except tuberculosis
514.........................................  Pulmonary congestion and hypostasis
530.7.......................................  Gastroesophageal laceration--hemorrhage syndrome
530.82......................................  Esophageal hemorrhage
531.00-535.61...............................  Gastric ulcer, duodenal ulcer, peptic ulcer, gastrojejunal ulcer,
                                               gastritis and duodenitis

[[Page 58835]]


555.0-555.9.................................  Regional enteritis
556.0-556.9.................................  Ulcerative colitis
557.0-557.9.................................  Vascular insufficiency of intestine
562.02--562.03..............................  Diverticulosis of small intestine with hemorrhage
562.10......................................  Diverticulosis of colon w/o hemorrhage
562.11......................................  Diverticulitis of colon w/o hemorrhage
562.12......................................  Diverticulosis of colon with hemorrhage
562.13......................................  Diverticulitis of colon with hemorrhage
568.81......................................  Hemoperitoneum (nontraumatic)
569.3.......................................  Hemorrhage of rectum and anus
571.0-571.9.................................  Chronic liver disease and cirrhosis
572.2.......................................  Hepatic coma
572.4.......................................  Hepatorenal syndrome
572.8.......................................  Other sequelae of chronic liver disease
573.1-573.9.................................  Hepatitis in viral diseases, other and unspecified disorder of
                                               liver
576.0-576.9.................................  Other disorders of Biliary tract
577.0.......................................  Acute pancreatitis
578.0-578.9.................................  Gastrointestinal hemorrhage
579.0-579.9.................................  Intestinal Malabsorption
581.0-581.9.................................  Nephrotic Syndrome
583.9.......................................  Nephritis, with unspecified pathological lesion in kidney
584.5-584.9.................................  Acute Renal Failure
585.........................................  Chronic Renal Failure
586.........................................  Renal failure, unspecified
593.81-593.89...............................  Other specified disorders of kidney and ureter
596.7.......................................  Hemorrhage into bladder wall
596.8.......................................  Other specified disorders of bladder
599.7.......................................  Hematuria
607.82......................................  Vascular disorders of penis
608.83......................................  Vascular disorders of male genital organs
611.8.......................................  Other specified disorders of breast--hematoma
620.7.......................................  Hemorrhage of broad ligament
621.4.......................................  Hematometra
622.8.......................................  Other specified noninflammatory disorders of cervix
623.6.......................................  Vaginal hematoma
623.8.......................................  Other specified noninflammatory disorders of the vagina
624.5.......................................  Hematoma of vulva
626.2-626.9.................................  Abnormal bleeding from female genital tract
627.0.......................................  Premenopausal menorrhagia
627.1.......................................  Postmenopausal bleeding
629.0.......................................  Hematocele female, not classified elsewhere
632.........................................  Missed abortion
634.10-634.12...............................  Spontaneous abortion, complicated by excessive hemorrhage
635.10-635.12...............................  Legally induced abortion, complicated by delayed or excessive
                                               hemorrhage
636.10-636.12...............................  Illegally induced abortion, complicated by delayed or excessive
                                               hemorrhage
637.10-637.12...............................  Abortion unspecified, complicated by delayed or excessive
                                               hemorrhage
638.1.......................................  Failed attempted abortion, complicated by delayed or excessive
                                               hemorrhage
639.1.......................................  Delayed or excessive hemorrhage following abortion and ectopic and
                                               molar pregnancies
639.6.......................................  Complications following abortion and ectopic and molar pregnancies
                                               with embolism
640.00-640.93...............................  Hemorrhage in early pregnancy
641.00-641.93...............................  Antepartum hemorrhage, abruptio placentae, and placenta previa
642.00-642.94...............................  Hypertension complicating pregnancy, childbirth, and the
                                               puerperium
646.70-646.73...............................  Liver disorders in pregnancy
656.00-656.03...............................  Fetal maternal hemorrhage
658.40-658.43...............................  Infection of amniotic cavity
666.00-666.34...............................  Postpartum hemorrhage
671.20-671.94...............................  Venous complications in pregnancy and the puerperium
673.00-673.84...............................  Obstetrical pulmonary embolism
674.30-674.34...............................  Other complications of obstetrical surgical wounds
713.2.......................................  Arthropathy associated with hematological disorders
713.6.......................................  Arthropathy associated with hypersensitivity reaction
719.15......................................  Hemarthrosis pelvic region and thigh
719.16......................................  Lower leg
719.19......................................  Multiple sites
729.5.......................................  Pain in limb
733.1.......................................  Patholgic fracture, unspecified site
746.00-746.9................................  Other Congenital anomalies of heart
762.1.......................................  Other forms of placental separation and hemorrhage
767.0-767.1.................................  Subdural and cerebral hemorrhage
767.8.......................................  Other specified birth trauma
770.3.......................................  Pulmonary hemorrhage
772.0-772.9.................................  Fetal and neonatal hemorrhage
774.6.......................................  Unspecified fetal and neonatal jaundice
776.0-776.9.................................  Hemorrhagic disease of the newborn

[[Page 58836]]


780.2.......................................  Syncope and collapse
782.3.......................................  Edema
782.4.......................................  Jaundice, unspecified, not of newborn
782.7.......................................  Spontaneous ecchymosis
784.7.......................................  Epistaxis
784.8.......................................  Hemorrhage from throat
785.4.......................................  Gangrene
785.50......................................  Shock without mention of trauma
786.05......................................  Shortness of breath
786.3.......................................  Hemoptysis
786.59......................................  Chest pain, other
789.00-789.09...............................  Abdominal pain
789.1.......................................  Hepatomegaly
789.5.......................................  Ascites
790.92......................................  Abnormal coagulation profile
790.94......................................  Euthyroid sick syndrome
791.2.......................................  Hemoglobinuria
794.8.......................................  Abnormal Liver Function Study
800.00-800.99...............................  Fracture of vault of skull
801.00-801.99...............................  Fracture of base of skull
802.20-802.9................................  Fracture of face bones
803.00-803.99...............................  Other and unqualified skull fractures
804.00-804.99...............................  Multiple fractures involving skull or face with other bones
805.00-806.9................................  Fracture, vertebral column
807.00-807.09...............................  Fractures of rib(s), closed
807.10-807.19...............................  Fracture of rib(s), open
808.8-808.9.................................  Fracture of Pelvis
809.0-809.1.................................  Ill-defined fractures of bones of Trunk
810.00-810.13...............................  Fracture of Clavicle
811.00-811.19...............................  Fracture of Scapula
812.00-812.59...............................  Fracture of Humerus
813.10-813.18...............................  Fracture of radius and ulna, upper end, open
813.30-813.38...............................  Shaft, open
813.50-813.58...............................  Lower end, open
813.90-813.98...............................  Fracture unspecified part, open
819.0-819.1.................................  Multiple fractures involving both upper limbs, closed and open
820.00-821.39...............................  Fracture of neck of femur
823.00-823.92...............................  Fracture of tibia and fibula
827.0-829.1.................................  Other multiple lower limb
852.00-852.59...............................  Subarachnoid, subdural, and extradural hemorrhage, following
                                               injury
853.00-853.19...............................  Other and specified intracranial hemorrhage following injury
852.00-853.19...............................  Subarachnoid subdural, and extradural hemorrhage, following
                                               injury, Other and specified intracranial hemorrhage following
                                               injury
860.0-860.5.................................  Traumatic pneumothorax and hemothorax
861.00-861.32...............................  Injury to heart and lung
862.0-862.9.................................  Injury to other and unspecified intrathoracic organs
863.0-863.9.................................  Injury to gastrointestinal tract
864.00-864.19...............................  Injury to liver
865.00-865.19...............................  Injury to spleen
866.00-866.13...............................  Injury to kidney
867.0-867.9.................................  Injury to pelvic organs
868.00-868.19...............................  Injury to other intra-abdominal organs
869.0-869.1.................................  Internal injury to unspecified or ill defined organs
900.00-900.9................................  Injury to blood vessels of head and neck
901.0-901.9.................................  Injury to blood vessels of the thorax
902.0-902.9.................................  Injury to blood vessels of the abdomen and pelvis
903.00-903.9................................  Injury to blood vessels of upper extremity
904.0-904.9.................................  Injury to blood vessels of lower extremity and unspecified sites
920-924.9...................................  Contusion with intact skin surface
925.1-929.9.................................  Crushing injury
958.2.......................................  Secondary and recurrent hemorrhage
959.9.......................................  Injury, unspecified site
964.0-964.9.................................  Poisoning by agents primarily affecting blood constituents
980.0-980.9.................................  Toxic effect of alcohol
981.........................................  Toxic effect of petroleum products
982.0-982.8.................................  Toxic effects of solvents other than petroleum-based
987.0-987.9.................................  Toxic effect of other gases, fumes or vapors
989.0-989.9.................................  Toxic effect of other substances chiefly non-medicinal as to
                                               source
995.2.......................................  Unspecified adverse effect of drug, medicinal and biological
                                               substance (due to correct medicinal substance properly
                                               administered)
996.82......................................  Complication of transplanted liver
997.4.......................................  Digestive system complications
998.11-998.12...............................  Hemorrhage or hematoma complicating a procedure
997.02......................................  Iatrogenic cerbrovascular infarction or hemorrhage


[[Continued on page 58837]]