[Federal Register Volume 65, Number 48 (Friday, March 10, 2000)]
[Proposed Rules]
[Pages 13082-13167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4834]



[[Page 13081]]

-----------------------------------------------------------------------

Part II





Department of Health and Human Services





-----------------------------------------------------------------------



Health Care Financing Administration



-----------------------------------------------------------------------



42 CFR Part 410



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

  Federal Register/Vol. 65, No. 48/Friday, March 10, 2000/Proposed 
Rules  

[[Page 13082]]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 410

[HCFA-3250-P]
RIN 0938-AJ53


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

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would establish 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. A Negotiated Rulemaking 
Committee (the Committee) developed the proposed policies as directed 
by section 4554(b)(1) of the Balanced Budget Act of 1997 (the BBA).

DATES: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on May 9, 
2000.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address: Health Care Financing Administration, Department of 
Health and Human Services, Attention: HCFA-3250-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    If you prefer, you may deliver your written comments (1 original 
and 3 copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or
Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-8016.

    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-3250-P. Comments received timely will be available 
for public inspection as they are received, generally beginning 
approximately 3 weeks after publication of a document, in Room 443-G of 
the Department's offices at 200 Independence Avenue, SW., Washington, 
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. 
(phone: (202) 690-7890).

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:
    Availability of Copies: To order copies of the Federal Register 
containing this document, send your request to: New Orders, 
Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-
7954. Specify the date of the issue requested, and enclose a check or 
money order payable to the Superintendent of Documents, or enclose your 
VISA, Discover, or MasterCard number and expiration date. Credit card 
orders can also be placed by calling the order desk at (202) 512-1800 
or by faxing to (202) 512-2250. The cost for each copy is $8. As an 
alternative, you can view and photocopy the Federal Register document 
at most libraries designated as Federal Depository Libraries and at 
many other public and academic libraries throughout the country that 
receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. Free public access is available on a Wide 
Area Information Server (WAIS) through the Internet and via 
asynchronous dial-in. Internet users can access the database by using 
the World Wide Web; the Superintendent of Documents home page address 
is http: -//www.access.gpo.gov/nara/index.html, by using local WAIS 
client software, or by telnet to swais.access.gpo.gov, then login as 
guest (no password required). Dial-in users should use communications 
software and modem to call 202-512-1661; type swais, then login as 
guest (no password required).

Overview

    In this proposed rule, we explain the establishment of a negotiated 
rulemaking committee to develop coverage and administrative policies 
for clinical diagnostic laboratory services payable under Medicare Part 
B. We set out and explain proposed revisions to regulations on clinical 
diagnostic laboratory services payable under Medicare Part B, including 
provisions relating to national administrative policies. The addenda to 
this proposed rule include the proposed national coverage policies that 
are proposed as national coverage decisions, and an introduction 
explaining the uniform format used by the Committee in developing those 
decisions.
    To assist readers in referencing sections contained in this 
proposed rule, we are providing the following table of contents:

Table of Contents

I. Background
    A. Current Statutory Authority and Medicare Policies
    B. Recent Legislation
II. Negotiated Rulemaking Process
    A. Convening the Committee
    B. Summary of the Committee Process
III. Proposed Policy Changes or Clarifications
    A. Information Required with Each Claim
    B. Medical Conditions for Which a Test May Be Reasonable and 
Necessary
    C. Appropriate Use of Procedure Codes
    D. Documentation and Recordkeeping Requirements
    E. Procedures for Filing Claims
    F. Limitation on Frequency
IV. Other Topics Discussed by the Committee
V. Provisions of the Proposed Regulation
VI. Effective Date of Provisions
VII. Collection of Information Requirements
VIII. Response to Comments
IX. Regulatory Impact Analysis

    Due to referral practices in the performance of clinical diagnostic 
laboratory tests, the laboratory performing the test may not be the 
entity authorized to bill Medicare for the service. In order to avoid 
confusion, in this proposed rule we have used the word ``laboratory'' 
when discussing requirements that apply universally to laboratories and 
the word ``entity billing Medicare'' (or a similar phrase) to indicate 
requirements that apply to a laboratory or other entity that is 
authorized to submit the Medicare claim for the service.

I. Background

    Note: Label comments about this section with the subject: 
``Background''.

A. Current Statutory Authority and Medicare Policies

    Section 1861(s)(3) 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.

[[Page 13083]]

    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. We 
have consistently interpreted this provision to exclude services that 
are not safe and effective, are experimental, and are not furnished in 
accordance with accepted standards of medical practice. (Some 
exceptions exist such as category B devices under evaluation with FDA 
protocals.) 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).''
    We have consistently interpreted these provisions to prohibit 
coverage of screening services, including clinical laboratory tests 
furnished in the absence of signs, symptoms, complaints, or personal 
history of disease or injury, except as explicitly authorized by 
statute.
    Under the above statutory authority, we have issued national 
coverage decisions and policies in a variety of documents, such as HCFA 
manual instructions, Federal Register notices, and HCFA Rulings. We 
have issued approximately 20 national coverage decisions pertaining to 
clinical diagnostic laboratory services in the Medicare Coverage Issues 
Manual (HCFA Pub. 6). Medicare program manuals are posted on the 
Internet at http://www. hcfa.gov/pubforms/progman.htm. Program 
transmittals and program memoranda are posted at http://www.hcfa.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 A (Hospital Insurance). Fiscal 
intermediaries also process claims payable from the Medicare Part B 
trust fund that are submitted by providers that participate in Medicare 
Part A, such as hospitals and skilled nursing facilities. We use the 
term ``contractor(s)'' to mean carriers and fiscal intermediaries.
    Medicare contractors review and adjudicate claims for services to 
assure 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 polices 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 7500ff of the Medicare 
Carriers Manual (HCFA Pub. 13-3).
    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 made LMRP, the 
contractor must change its LMRP to conform it 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.

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) 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 conditions for which a laboratory test is 
reasonable and necessary (within the meaning of section 1862(a)(1)(A) 
of the Social Security 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 physician's 
obligations regarding such 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. Negotiated Rulemaking Process

    Note: Label comments about this section with the subject: 
``Negotiated Rulemaking Process''.

A. Convening the Committee

    Negotiated rulemaking under the Negotiated Rulemaking Act (Public 
Law 101-648) 5 U.S.C. 561-570 is a process by which a committee of 
representatives of interests that may be significantly affected by a 
proposed rule, together with an agency representative attempt to reach 
consensus on the text or content of a proposed rule. The Committee is 
assisted by an impartial facilitator or mediator.
    A convening process was followed to determine the interests likely 
to be significantly affected by the proposed rule and the individuals 
who should be appointed to the Committee to represent those interests. 
Impartial conveners interviewed potential representatives and made 
recommendations in a convening report. We considered the conveners' 
recommendations and published a notice of intent to negotiate on June 
3, 1998 in the Federal Register (63 FR 30166). That notice described 
the scope of the negotiations and proposed Committee membership. 
Committee membership is based on responses to the notice, and the 
Committee is chartered under the Federal Advisory Committee Act (FACA) 
(5 U.S.C. App. 2). One additional member was added by consensus of the 
Committee. Committee members represented the following organizations:

[[Page 13084]]

     American Association of Bioanalysts.
     American Association for Clinical Chemistry.
     American Association of Retired Persons (AARP).
     American Clinical Laboratory Association.
     American College of Physicians--American Society of 
Internal Medicine.
     American Health Information Management Association.
     American Hospital Association.
     American Medical Association.
     American Medical Group Association.
     American Society for Clinical Laboratory Science.
     American Society of Clinical Pathologists.
     American Society for Microbiology.
     Clinical Laboratory Management Association.
     American Society for Clinical Laboratory Science.
     College of American Pathologists.
     Health Industry Manufacturers Association.
     Medical Group Management Association.
     National Medical Association.
    In addition, we represented the Department of Health and Human 
Services on the Committee.

B. Summary of the Committee Process

    The Committee met nine times from July 13, 1998 to January 27, 1999 
and again on August 30 and 31. We published notices of meetings in the 
Federal Register on June 3, 1998 (63 FR 30166), August 11, 1998 (63 FR 
42796), January 4, 1999 (64 FR 69), and August 10, 1999 (64 FR 43338). 
We posted detailed agendas and minutes for each of these meetings on 
the HCFA web page at http://www.hcfa.gov/quality/qlty-8a.htm.
    The Committee operated under organizational groundrules that it 
adopted by consensus. The organizational groundrule on ``consensus'' 
provided for the following:
     The Committee would operate by consensus.
     The Committee would make decisions with the unanimous 
concurrence of Committee members.
     Concurrence would mean only that the Committee member 
could live with the decision being considered by the Committee.
     An abstention would be the same as a concurrence for 
purposes of determining consensus.
    Committee meetings were open to the general public. In addition, 
the Committee provided opportunities for the general public to submit 
written and oral comments.
    The Committee prepared and signed an agreement at the conclusion of 
the meetings. The agreement states the provisions for which the 
Committee reached consensus in a consensus report. The Committee 
members agreed that they would not submit negative comments on this 
proposed rule as long as it has the same substance and effect as the 
consensus report. In addition, the Committee developed proposed 
national coverage decisions for certain clinical diagnostic laboratory 
tests or groups of tests. The Committee formed six workgroups to assist 
with this task and a ``Drafting Workgroup''. Each Committee member was 
permitted, but not required, to appoint a representative to each 
workgroup. The agreement signed by Committee Members represents 
``consensus'' under the definition set out above. Thus, a Member may 
have chosen to abstain on some of the matters negotiated, rather than 
affirmatively indicating concurrence. In particular, the AARP did not 
participate in the workgroups which developed proposed national 
coverage policies for specific tests, and in this agreement defers to 
Committee members with specialized expertise in the areas covered. 
Therefore, the AARP's general concurrence reflects its abstention on 
the proposed national coverage policies for specific tests.

III. Proposed Policy Changes and Clarifications

    Section 4554(b)(2) of the BBA explicitly directs that a negotiated 
rulemaking committee negotiate coverage and administrative policies for 
clinical diagnostic laboratory services ``payable under part B.'' 
Therefore, these Medicare policies apply to all laboratory services 
billed to Medicare Part B regardless of the location of the entity 
furnishing the service (physicians' office laboratories, hospital 
laboratories, independent laboratories, etc., or of the type of 
Medicare contractor processing the claims (carriers or fiscal 
intermediaries).
    Any policy relating to the ordering of clinical diagnostic 
laboratory tests applies whether the individual ordering the test is a 
physician or a nonphysician practitioner qualified under 
Sec. 410.32(a)(3) to order diagnostic tests. Section 410.32(a)(3) 
provides that nonphysician practitioners (that is, clinical nurse 
specialists, clinical psychologists, clinical social workers, nurse 
midwives, nurse practitioners, and physician assistants) who furnish 
services that would be physicians' services if furnished by a 
physician, and who are operating within the scope of their authority 
under State law and within the scope of their Medicare statutory 
benefit, may be treated the same as physicians treating beneficiaries 
for purposes of Sec. 410.32. Thus, where this proposed rule discusses 
ordering clinical laboratory tests and refers to a ``physician,'' it 
means either a physician or a qualified nonphysician practitioner as 
defined in Sec. 410.32(a)(3).
    These proposed regulations do not purport to provide any immunities 
or safe harbors. The provisions of this proposed rule are not intended 
to limit criminal, civil or administrative law enforcement or 
overpayment recoveries.

A. Information Required With Each Claim

    Note: Label comments about this section with the subject: 
``Information Required with Claim.''

1. Required Data Fields
    Section 4554(b)(2)(A) of the BBA directs the Committee to negotiate 
policies that are designed to promote program integrity and national 
uniformity, and to simplify administrative requirements for beneficiary 
information that must be submitted with each claim for laboratory 
services. The Committee reviewed the existing Medicare claims 
processing requirements that are outlined in the Medicare Carriers 
Manual (HCFA Pub. 14-3) sections 3005 and 3999, exhibit 10, and in the 
Medicare Fiscal Intermediary Manual (HCFA Pub. 13-3) section 3605 and 
Addendum L.
    The Committee discussed the existing requirements related to 
information that must be submitted with the claims. To promote 
administrative simplicity, some members of the Committee suggested that 
the preamble to this rule include a listing of the specific data 
elements that are required for laboratory claims. However, the data 
elements that are required for a claim for a laboratory service may 
vary depending on certain factors. For example, required data fields 
will vary with the individual circumstances of the beneficiary, such as 
secondary payer situations; and the particular service furnished.
    Moreover, claims processing requirements may be subject to change 
as other program requirements are modified or as the uniform 
requirements enacted under the Health Insurance Portability and 
Accountability Act (HIPAA) are implemented. Some members of the 
Committee expressed concern that having a list in the preamble that may 
rapidly become inaccurate could generate increased opportunity for 
errors or confusion. Thus, the Committee agreed to

[[Page 13085]]

encourage readers to refer to the claims processing sections of the 
Medicare Carriers Manual (section 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. As noted above, these manuals are posted on the Internet at 
http://www.hcfa.gov/pubforms/progman.htm.
2. Diagnostic Information Requirement
    The Committee discussed when diagnostic information to support 
medical necessity must be submitted with a claim. The 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 
on 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; however, there may be other requirements for a diagnosis 
code with every claim. The Committee recommended, however, that 
physicians be encouraged voluntarily to provide diagnosis information 
(either the reason for the visit or the reason for the test) with the 
order, and laboratories be encouraged to submit information that they 
receive with the claim.
3. Date of Service
    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.
    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-9J-4 in April, 1995 
that instructed some laboratories, primarily hospital-based 
laboratories, to report the date of performance as the date of service 
on automated multi-channel tests.
    After considerable discussion the Committee reached consensus that 
the date of service for Medicare claim purposes should be the date the 
tested specimen was collected and that the person obtaining the 
specimen must furnish the date of collection of the specimen to the 
entity billing Medicare. However, the Committee felt that further input 
was needed to make an informed decision to determine appropriate date 
of service for Medicare claim purposes. We are committed to the concept 
that we should establish a national policy regarding date of service 
for Medicare claims that will promote program integrity and national 
uniformity, yet minimize the burden on laboratories. Therefore, we are 
specifically soliciting public comment on this issue from organizations 
serving on the Negotiated Rulemaking as well as others. As discussed 
below in ``Effective Date of Provisions'', we are proposing to provide 
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 Committee's negotiations. 
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.

B. Medical Conditions for Which a Test May Be Reasonable and Necessary

    Note: Label comments about this section with the subject: 
``National Coverage Decisions''.


    Section 4554(b)(2) of the Act instructs the Committee to consider 
the medical conditions for which a laboratory test is considered 
reasonable and necessary (within the meaning of section 1862(a)(1)(A) 
of the Act) in developing national coverage policies. These policies 
must be designed to promote program integrity and national uniformity 
and simplify administrative requirements. We are promulgating these 
policies as ``national coverage decisions'' under section 1862(a)(1) of 
the Act, as defined in Sec. 405.732. These decisions are binding upon 
the claims processing contractors as well as the review and appeal 
entities.
1. The Committee Process Used for Proposed National Coverage Decisions
    The Committee reached consensus to outline the specific medical 
conditions for which a number of specific clinical laboratory services 
may be reasonable and necessary. The Committee developed an extensive 
list of tests for which it believed that a national coverage decision 
was appropriate. It focused on those services that have a diversity of 
LMRPs.
    Given the large number of tests under consideration, the Committee 
used workgroups to assist with the development of the coverage 
decisions. The Committee formed workgroups to address laboratory tests 
in six major clinical categories and assigned and prioritized tests (or 
groups of tests) to the workgroups. The six clinical categories of 
tests were endocrinology and metabolism, cardiology and other 
therapeutic drug monitoring, hematology and coagulation, oncology and 
anatomic pathology, infectious diseases, and gastrointestinal and 
renal.
    Each workgroup was co-chaired by two Committee members. Each 
Committee member was entitled to appoint a designee to each workgroup. 
In addition, each workgroup had at least one Medicare carrier medical 
director as a nonvoting technical consultant. Each workgroup included, 
at a minimum, a pathologist, another specialty physician, a primary 
care physician, a laboratory expert, a coding expert, and a Medicare 
expert (HCFA staff).
    To ensure that the workgroups approached the task consistently, the 
Committee negotiated a process to be used by the workgroups to develop 
draft recommendations for proposed national coverage decisions. The 
national coverage decisions are based on authoritative evidence. In 
addition, the national coverage decisions reflect common, generally 
accepted medical practice through the input of nationally recognized 
organizations, rather than solely the opinion of individual 
practitioners. The workgroup process included the following:
     Seeking input from relevant national medical specialty 
societies and voluntary health agencies through the AMA representative.
     Reviewing relevant scientific literature and practice 
guidelines.

[[Page 13086]]

     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.
    Because of the statutory deadline for the Committee's work, the 
workgroups operated under very tight time constraints. Workgroup 
members communicated by telephone conference calls, e-mail, and FAX.
    Workgroup recommendations were posted on the HCFA website for the 
negotiations by November 4, 1998 and public comments were solicited 
through November 11, 1998. At the Committee's November meeting, the 
full Committee considered each workgroup's recommendations, and any 
comments from the public or from other Committee members. The Committee 
modified the draft policies, where necessary, in order to respond to 
comments and to achieve consensus.
    The Committee reached consensus on the 23 proposed national 
coverage decisions included in Addendum B. In addition, the Committee 
reached consensus on the introductory explanation of those decisions 
included in Addendum A. The Committee reached consensus that the 
decisions should be published in manual form, rather than as a codified 
regulation. This would ensure that coverage decisions are updated in a 
timely manner as appropriate (for example, changes in technology, 
coding, or national practice standards).
2. Uniform Format
    The Committee used a uniform format for the proposed national 
coverage decisions that included a narrative description of the test, 
panel of tests, or group of tests addressed in the decision; 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).
    The lists of ICD-9-CM codes in each policy were derived from the 
narrative description, indications, and, in some decisions, 
limitations, and are included in the decisions to achieve the statutory 
objective to promote national uniformity in processing claims. The 
codes are listed in one of the following three sections: (1) ICD-9-CM 
codes covered by Medicare program; (2) ICD-9-CM codes denied; and (3) 
ICD-9-CM codes that do not support medical necessity.
    The first section lists covered codes--those for which there is a 
presumption of medical necessity. Diagnoses listed in this section may 
support medical necessity of the claim, but the claim may be subject to 
review to determine whether the test was in fact reasonable and 
necessary in the particular circumstances presented. If the policy 
takes an ``exclusionary'' approach (described below), this section 
states: ``Any ICD-9-CM code not listed in either of the ICD-9-CM code 
sections below.''
    The second section lists diagnosis codes that are never covered. If 
an ICD-9-CM code listed in this section is submitted with the claim, 
the test may be initially billed to the Medicare beneficiary without 
billing Medicare because the test is a service that is not covered by 
Medicare under any circumstances, such as a screening service that is 
not paid for under a statutory screening exception. The beneficiary, 
however, does have a right to have the claim submitted to Medicare.
    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. Generally, diagnoses in this 
section will result in denial. In certain circumstances, however, 
additional documentation could support a decision of medical necessity 
and must be submitted by the ordering provider to the billing entity 
for submission with the claim. In other circumstances, it may be 
appropriate for the ordering physician or the laboratory to obtain an 
advance beneficiary notice from the beneficiary consistent with 
Sec. 7300.5 of the Medicare Carriers Manual and Sec. 3430--3432.1 of 
the Fiscal Intermediary Manual. If the policy takes an ``inclusionary'' 
approach (described below), this section of the policy states: ``Any 
ICD-9-CM code not listed in either of the ICD-9-CM sections above.''
    Each proposed national coverage decision published in Addendum B 
includes a section titled ``Reasons for Denial.'' The Committee did not 
negotiate the language included in this section. The language 
represents our interpretation of Medicare's longstanding policies. It 
is included in the national coverage decision for informational 
purposes.
    Each proposed decision contains a section for sources of 
information on which the decision is based. A national coverage 
decision must be based on authoritative evidence. Authoritative 
evidence could include peer-reviewed medical literature, clinical 
practice guidelines or consensus, and formal opinions of national 
medical specialty societies and national voluntary health 
organizations.
    Coding guidelines that apply to all tests are included in each 
proposed policy. Some policies contain additional coding guidelines 
relevant for the specific test or group of tests addressed in the 
policy.
    To develop national coverage decisions for the tests assigned to 
each workgroup, the Committee agreed to use one of two approaches, 
referred to as ``inclusionary'' and ``exclusionary.'' Decisions 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 decisions do not list the codes that require 
additional documentation to support medical necessity.
    The ``exclusionary'' approach was used for tests for which LMRPs 
identified a large number of acceptable ICD-9-CM codes. The Committee 
used this approach to develop a proposed policy on blood counts, 
including complete blood counts. In lieu of listing all the ICD-9-CM 
codes that support medical necessity of a test or group of tests, 
decisions 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. Any diagnosis code not listed in 
either of those two categories is presumed to support the medical 
necessity of the billed services.
3. Explanation of Effect of a National Coverage Decision
    A national coverage decision for a diagnostic laboratory test is a 
document that includes the circumstances under which the test may be 
considered reasonable and necessary and, therefore payable under 
Medicare. This decision applies nationwide and is binding on all 
Medicare carriers, fiscal intermediaries, peer review organizations, 
health maintenance organizations, competitive medical plans, and health 
care prepayment plans when published in a HCFA program manual or the 
Federal Register. The decisions published in Addendum B of this 
proposed rule would, when final, be national coverage decisions under 
section 1862(a)(1) of the Act and regulations codified at Sec. 405.732. 
When final, these decisions may not be disregarded, set aside, or 
otherwise reviewed by an Administrative Law Judge. A court's review of 
a national coverage decision is limited to whether the record is 
incomplete or otherwise lacks adequate information to support the 
validity of the decision, unless the case has been remanded to the 
Secretary to supplement the record previously.

[[Page 13087]]

4. Proposed Decisions Developed by the Committee
    The committee developed proposed national policy decisions for the 
following tests:
     Urine bacterial culture.
     Human immunodeficiency virus testing (prognosis, including 
monitoring).
     Human immunodeficiency virus (diagnosis).
     Blood counts.
     Partial thromboplastin time.
     Prothrombin time.
     Iron studies.
     Blood glucose.
     Glycated hemoglobin/glycated protein.
     Thyroid testing.
     Collagen crosslinks.
     Lipids.
     Digoxin.
     Alpha-fetoprotein.
     Carcinoembronic Antigen.
     Human chorionic gonadotropin.
     Tumor antigen by immunoassay-CA 125.
     Tumor antigen by immunoassay-CA 15-3/CA27.29.
     Tumor antigen by immunoassay-CA 19-9.
     Total Prostate specific antigen.
     Gamma glutamyltransferase.
     Hepatitis panel.
     Fecal occult blood.
5. Request for Comments
    The Committee encourages comment on these proposed policies. The 
Committee recognizes that these proposed policies address important and 
complex questions concerning the medical necessity of clinical 
diagnostic laboratory services. The Committee sought to develop 
evidence-based proposed policies for clinical diagnostic laboratory 
services that promote program integrity. The Committee found it 
difficult to do this in some cases because generally accepted medical 
practice may include testing that is excluded by statute from Medicare 
coverage, for example, blood glucose screening of patients at high risk 
for diabetes. The Committee believes that its proposed policies address 
many concerns that have been raised by the variation among LMRPs. In 
view of the short time period allowed by the BBA for addressing these 
complicated issues, the Committee requests public comment, particularly 
from those with evidence that would support any proposed changes. We 
encourage commenters to submit, with their comments, copies of medical 
literature supporting their recommendation for change, rather than 
simply providing the references to appropriate medical sources.
6. Ongoing Coverage Process
    The Committee discussed whether there should be an ongoing process 
to update these policies, once they are final, and/or to develop 
additional national coverage policies for other diagnostic laboratory 
tests or groups of tests. We informed the Committee about steps we are 
taking to develop a process to address coverage issues for all Medicare 
services, including laboratory tests. See 80 FR 22619 published April 
27, 1999.
    The Committee discussed how this process could be used to update 
the national coverage policies resulting from Committee negotiations, 
as well as to develop additional policies. We assured Committee Members 
that they would have an opportunity to comment on that process and on 
any policies being developed using that process. In light of the 
information provided and recognizing that section 4554(b)(6) of the 
Balanced Budget Act provides an opportunity for public notice and 
comment in a biennial review of laboratory coverage policies, the 
Committee discontinued its discussions about whether there should be a 
separate coverage process for laboratory tests.

C. Appropriate Use of Procedure Codes

    Note: Label comments about this section with the subject: 
``Procedure Codes''.


    The Committee also discussed issues related to procedure codes and 
modifiers under HCFA's Common Procedure Coding System (HCPCS). HCPCS 
codes include Current Procedural Terminology (CPT) codes developed by 
the CPT Editorial Panel of the American Medical Association (AMA) that 
are copyrighted by the AMA. The Committee reached consensus that 
certain procedure codes or modifiers should be clarified in this 
preamble.
1. Use of the Word ``Screening'' in Descriptor
    Some Committee members noted that use of the words ``screen'' or 
``screening'' in the descriptor of some CPT codes may cause confusion 
in distinguishing between screening for a disease or disease precursors 
using a laboratory test (which is generally excluded from Medicare 
coverage), and screening for a specific analyte or group of related 
analytes using a laboratory test (which may be covered under Medicare). 
The use of the term ``screening'' or ``screen'' in these CPT code 
descriptors does not necessarily describe a test performed in the 
absence of signs or symptoms of an illness, disease, or condition. The 
failure to make this distinction may lead to inappropriate denial of 
claims.
    If a test is reasonable and necessary for diagnosing or treating a 
beneficiary's medical condition, Medicare covers testing for a specific 
analyte or group of related analytes, even though the words ``screen'' 
or ``screening'' may appear in the CPT code descriptor for the test. 
Examples of CPT codes where screening for an analyte may be used 
diagnostically include the following:
     83068: Hemoglobin; unstable, screen.
     86255: Fluorescent noninfectious agent antibody; screen, 
each antibody.
     87081: Culture bacterial; screening, for single organisms.
    We will include this clarification in instructions we issue to the 
contractors.
2. Multiple Testing
    Committee members also noted potential confusion about multiple 
claim submissions by a laboratory for the same CPT code for the same 
beneficiary for the same day. Generally, multiple testing is considered 
to be duplicative and is not payable under Medicare. Under certain 
circumstances, however, claims for multiple services assigned the same 
CPT code may be submitted because the multiple services are medically 
necessary to diagnose or treat the beneficiary's condition. In these 
circumstances, presently the laboratory must use CPT modifier ``-59.'' 
CPT modifier ``-59'' is defined in Appendix A of Current Procedural 
Terminology, Fourth Edition in part, as follows:

    Distinct procedural service: Under certain circumstances, the 
physician may need to indicate that a procedure or service was 
distinct or independent from other services performed on the same 
day. Modifier ``-59'' is used to identify procedures/services that 
are not normally reported together, but are appropriate under the 
circumstances. This may represent a different session or patient 
encounter, different procedure or surgery, different site or organ 
system, separate incision/excision, separate lesion, or separate 
injury (or area of injury in extensive injuries) not ordinarily 
encountered or performed on the same day by the same physician.

    This modifier replaced the previous HCPCS modifier ``GB'' (Distinct 
procedural service).
    A few examples of appropriate use of CPT modifier ``-59'' are the 
following:
     Biochemical studies performed on different samples, for 
example, renins (CPT code 84244).

[[Page 13088]]

     Multiple blood cultures (CPT codes 87040 and 87103), 
generally 2-3 collected to document etiology of sepsis.
     Multiple lesion samples collected from distinct anatomic 
sites for culture for bacteria (CPT codes 87070 and 87075).
    The American Medical Association's CPT Editorial Panel is 
considering changes in the modifier codes to indicate multiple services 
for the year 2000 update. If such changes are implemented, they may 
alter the clarification discussed above. We will issue instructions to 
our contractors addressing modifiers to indicate that a procedure or 
service is distinct or independent from other services performed on the 
same day.

D. Documentation and Recordkeeping Requirements

    Note:
    Label comments about this section with the subject: 
``Documentation''.


    Section 4554(b)(2) of the BBA provides for uniform national 
coverage and administrative policies in connection with ``[t]he medical 
documentation that is required by a Medicare contractor at the time a 
claim is submitted for a laboratory test'' and ``[r]ecordkeeping 
requirements in addition to any information required to be submitted 
with a claim, including physicians' obligations regarding such 
requirements.'' Section 4317 of the BBA provides, with respect to 
diagnostic laboratory and certain other services, that ``if the 
Secretary (or fiscal agent of the Secretary) requires the entity 
furnishing the * * * service to provide diagnostic or other medical 
information in order for payment to be made to the entity, the 
physician or practitioner [ordering the service] shall provide that 
information to the entity at the time the * * * service is ordered by 
the physician or practitioner.''
1. Maintenance of Documentation
    Since section 1862(a)(1)(A) of the Act prohibits Medicare payment 
for services that are not reasonable and necessary for the diagnosis or 
treatment of illness or injury, information describing the patient's 
signs, symptoms or medical condition(s) documenting the circumstances 
making laboratory services medically necessary must be maintained in a 
form that can be accessible or retrievable.
    The Committee discussed what documentation generally exists with 
each entity. The Committee's consensus reflects members' understanding 
of existing responsibilities for maintaining information regarding 
medical necessity of clinical diagnostic laboratory services and 
accuracy of claims submissions. Generally, physicians maintain 
information in the patient's medical record, and laboratories maintain 
the information provided to them by the ordering physician. To promote 
uniformity, the Committee's consensus was that we propose a codified 
regulation addressing documentation and recordkeeping requirements for 
clinical diagnostic laboratory services consistent with present 
practices.
    We are proposing to add a new paragraph (d)(2)(i) to Sec. 410.32 to 
clarify that the ordering physician is responsible for maintaining 
documentation of medical necessity in the beneficiary's medical record. 
In addition, we are proposing to add paragraph (d)(2)(ii) to 
Sec. 410.32 to clarify that the entity submitting the claim must 
maintain the documentation it receives from the ordering physician and 
the documentation that the claim information that it submitted to the 
Medicare contractor accurately reflects the documentation received from 
the ordering physician.
    We are also proposing to add a new paragraph (d)(2)(iii) to 
Sec. 410.32 to clarify that the entity submitting the claim may request 
additional diagnostic and other information to document that the 
services it bills are reasonable and necessary. Examples of situations 
in which a billing entity may wish to seek additional documentation may 
include, but would not be limited to, situations where diagnostic 
information is not submitted with an order for a test for which there 
is a national coverage decision or LMRP; where data analysis indicate 
that the particular beneficiary may exceed applicable frequency 
parameters for this particular test, or where there is an indication of 
potential aberrant utilization. In making requests for additional 
information, laboratories should focus their requests on material 
relevant to medical necessity of the services billed. In addition, 
documentation requests must take into account current rules and 
regulations related to patient confidentiality that are applicable in 
the area where the physician is practicing.
2. Submission of Documentation
    The Committee discussed who should be responsible for supplying 
documentation when a Medicare contractor reviews a laboratory claim. 
The Committee acknowledges that, for program integrity purposes, 
Medicare make payments only for services that are reasonable and 
necessary under Medicare. The Committee consensus is based on the 
general principle that physicians and laboratories may each be 
requested to provide the information that they maintain (as described 
below) but does not alter the responsibility of the entity submitting 
the claim.
    Specifically, the Committee consensus was that, upon request, 
laboratories must supply documentation that they maintain, such as the 
requisition from the ordering physician. We are proposing to add a new 
paragraph (d)(3)(i) to Sec. 410.32(d) to specify that, upon request, 
the entity submitting the claim must provide the following information: 
(1) Documentation of the physician's order for the service billed, 
including information sufficient to enable us to identify and contact 
the ordering physician; (2) documentation showing accurate processing 
of the order and submission of the claim; and, (3) diagnostic and other 
medical information that supports medical necessity supplied to the 
laboratory by the ordering physician or qualified nonphysician 
practitioner, including any ICD-9-CM code or narrative description 
supplied.
    The entity submitting a claim is responsible for documentation of 
medical necessity of the services to justify and support Medicare 
payment of the claim. Some Committee members, however, expressed 
concerns about protecting beneficiary confidentiality if laboratories 
are required to handle beneficiary medical records. The Committee 
agreed that if the information supplied by the entity submitting the 
claim (laboratory) was not sufficient to demonstrate that the services 
were reasonable and necessary, then we would seek additional 
information directly from the ordering physician. If the ordering 
physician does not supply the information, we will notify the 
laboratory and deny the claim.
    We are proposing to add a new paragraph (d)(3)(ii) to Sec. 410.32 
to specify that, if the documentation provided under paragraph 
(d)(3)(i) by the entity submitting the claim does not demonstrate that 
the service is reasonable and necessary, we would take the following 
actions: (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 would be the entity to 
experience a

[[Page 13089]]

payment denial if documentation does not support the medical necessity 
of the claim, the Committee agreed that the basic premise that Medicare 
would seek additional diagnostic and other medical information from the 
entity that usually maintains that documentation--the ordering 
physician--does not preclude the laboratory 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 current rules and regulations related to patient 
confidentiality that are applicable in the area where the physician is 
practicing.
    Similar to proposed paragraph (d)(2)(iii) of Sec. 410.32, we are 
proposing to add a new paragraph (d)(3)(iii) to Sec. 410.32 to state 
that the entity submitting the claim may request additional diagnostic 
and other medical information to document that the services for which 
it bills are reasonable and necessary. When such a request is made, it 
must be focused on material relevant to the medical necessity of the 
specific test(s), taking into consideration current rules and 
regulations on patient confidentiality.
3. Signature on Requisition
    Section 410.32(a) requires that all 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. Regulations implementing the Clinical Laboratory 
Improvement Act (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. 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.
    The Committee consensus is that this issue would be resolved by our 
publication of 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 
will issue a program instruction that reiterates this point.
4. Retention of Records
    The Committee discussed the length of time that records to document 
medical necessity for clinical diagnostic laboratory services must be 
retained. The Committee consensus was to identify, in this preamble, 
current record retention requirements in Federal law. The provisions of 
the Federal statutes and regulations that pertain specifically to 
retention of records related to laboratory testing, including a brief 
summary of those provisions are set forth as follows:
     42 CFR 482.24(b)(1), ``Condition of Participation for 
Hospitals--Standard: Form and Retention of Record'' specifies that 
medical records must be retained in their original or legally 
reproduced form for at least 5 years.
     42 CFR 488.5(a) and 488.6, which discuss accreditation 
standards for hospitals or other providers or suppliers deemed to meet 
applicable Medicare conditions of participation, include record 
retention standards.
     42 CFR 493.1105, which implements the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), specifies that records of test 
requisitions or test authorizations must be retained for a minimum of 2 
years. The patient's chart or medical record, if used as the test 
requisition, must be retained for a minimum of 2 years and must be 
available to the laboratory at the time of testing and be available to 
us upon request.
     42 CFR 493.1107 specifies that records of patient testing, 
including, if applicable, instrument printouts, must be retained for at 
least 2 years. Immunohematology and transfusion records must be 
retained for no less than 5 years in accordance with 21 CFR part 606, 
subpart I.
     42 CFR 493.1107 and 1109 state that records of blood and 
blood product testing must be maintained for a period not less than 5 
years after processing records have been completed, or 6 months after 
the latest expiration date, whichever is the later date, in accordance 
with 21 CFR 606.160(d).
     42 CFR 493.1257(g) specifies that the laboratory must 
retain all slide preparation for cytology exams for 5 years from the 
date of examination, or slides may be loaned to proficiency testing 
programs, in lieu of maintaining them for this time period.
     42 CFR 1003.132, related to civil monetary penalties, 
assessments, and exclusions, states that an action must begin within 6 
years from the date on which the claim was presented, the request for 
payment was made, or the incident occurred.

E. Procedures for Filing Claims

    Note: Label comments about this section with the subject: 
``Claims Processing''.

1. Coding of Narrative Diagnoses
    Most laboratory claims are submitted to us electronically. 
Laboratories that receive narrative diagnosis information from an 
ordering physician must translate that information into an appropriate 
diagnosis code (ICD-9-CM code) to submit the claim electronically. The 
Committee discussed policies for assigning an ICD-9-CM code if there is 
not an exact match between the code descriptor and the narrative the 
laboratory received from the ordering physician. The Committee 
consensus was that an appropriate diagnosis code may be assigned to a 
narrative, even if the wording of the narrative does not exactly match 
the code descriptor for the ICD-9-CM code. If an ICD-9-CM code is 
submitted by the ordering physician, laboratories must use that code in 
submitting the claim unless the laboratory has obtained documentation 
from the physician to support altering the code. For example, if a 
physician submits an incomplete code (that is, only 3 digits of a code 
that requires 5 digits), the laboratory must document the appropriate 
subclassification if it is required to report a code on the claim. We 
will include this clarification in future program instructions.
2. Limitation on Number of Diagnoses
    The Committee discussed variation among Medicare contractor's in 
the number of ICD-9-CM codes on a claim form that the contractor's 
computer systems will accept. If a contractor's system accepts a 
limited number of codes, a claim may be denied even if the physician 
who ordered the test supplied a code that would support the medical 
necessity of the test. The Committee was informed that, when proposed 
HIPAA standards are implemented, eight ICD-9-CM codes will be permitted 
on electronic claims. Committee members provided information indicating 
that this number would be sufficient for the vast majority of claims.
    Until HIPAA 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. If it 
would require the Medicare contractor to make a change in its

[[Page 13090]]

claims processing system in order to use this information for automated 
claims processing, the additional diagnoses would only be used by the 
contractor in processing claims that were suspended for manual review.
3. Matching of Diagnosis to Procedure
    All Medicare contractors presently process claims using any 
diagnosis-to-procedure code matching supplied by the laboratory. Some 
Committee members wished to find a way to have contractors examine all 
submitted codes. The Committee consensus was that, in the absence of 
matching of codes supplied by the laboratory, Medicare contractors must 
examine all submitted codes on prepayment review, taking into account 
program integrity concerns. Claims will not be denied solely because 
there is no matching of diagnosis and procedure codes on the claim 
form. We will include this clarification in future instructions to our 
contractors.
    The Committee also discussed ways of avoiding denial of an entire 
claim if it is submitted with diagnosis codes for multiple procedures 
(tests) and one of the diagnosis codes indicates screening, but the 
laboratory does not link the diagnosis and procedure codes. The 
Committee was concerned that absent information indicating which 
test(s) is performed for which diagnosis, the contractor may deny all 
of the claimed services after examining the diagnosis codes.
    The Committee consensus was that laboratories have the option of 
submitting a separate claim for the procedure that is not covered by 
Medicare. We would instruct the Medicare contractors to allow this 
option.
    In order to ensure that noncovered procedures can be identified, 
ordering providers must supply to the laboratory the necessary 
information to specifically identify any noncovered test ordered, such 
as a test ordered for screening purposes. When this information is 
supplied to the laboratory, the laboratory must supply this information 
with any claim for the noncovered service. For example, when an ICD-9-
CM code that indicates screening is provided by the physician, the 
laboratory must either submit a separate claim for the procedure that 
is not covered by Medicare or match that code on a claim form with the 
CPT code(s) provided for that purpose.

F. Limitation on Frequency

    Note: Label comments about this section with the subject: 
``Frequency''.

    Section 4554(b)(2) of the BBA instructs the Committee to negotiate 
policies that take into consideration ``Limitations on frequency of 
coverage for the same tests performed on the same individual.''
1. Notice of Frequency Screens
    The Committee discussed the use of frequency screens and their 
impact on the laboratory community. Some Committee members noted that, 
since frequency screens are a program integrity tool and therefore are 
not published, there is no means for a laboratory to know when a claim 
would be reviewed and perhaps denied in the absence of additional 
documentation of medical necessity. After studying the data on 
frequency denials and discussing the issue, we agreed that a frequency 
screen would not result in a frequency-based denial unless information 
published by us or our contractor includes an indication of the 
frequency that is generally considered reasonable utilization of that 
test for Medicare payment purposes.
    We will issue instructions to Medicare contractors through a 
revision to the program integrity sections of the Medicare Carriers 
Manual and Fiscal Intermediary Manual. In the future, we will be moving 
this information to the Program Integrity Manual. These instructions 
will provide that, except for egregious utilization, contractors may 
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. The information regarding appropriate frequency either may 
include the frequency with which the service is generally considered 
reasonable utilization for Medicare purposes or may be an absolute 
limit on coverage. The information must be published in advance of 
implementation of a frequency screen in a form, such as a contractor 
bulletin, that is widely disseminated to affected providers and 
suppliers. The contractor must consult with appropriate advisors, 
including medical specialty and other organizations before developing 
and publishing local frequency information for a clinical diagnostic 
laboratory test. Local frequency information for a particular test may 
not conflict with a national coverage decision or policy that includes 
frequency information for that test.
    If a Medicare contractor has been applying a frequency screen in 
the absence of published information about the frequency expectation, 
the contractor must either publish information about the appropriate 
frequency or stop using the frequency screen. Frequency screens that 
can result in denial must not be more restrictive than the frequency 
described in the published information. Contractors may, however, 
continue to deal with egregious utilization without prior publication 
of frequency information by using Category III edits described in 
section 7506.2 of the Medicare Carriers Manual, which are typically 
provider specific.
2. Automatic Denial and Manual Review
    The Committee discussed Medicare policy on automatic denials of 
laboratory claims as the policy applies to frequency screens. The 
Committee consensus is that the current policy regarding automatic 
denial and manual review of claims as stated in Medicare Carriers 
Manual sections 7505.1 and 7506 is appropriate and should be codified 
in regulations.
    We are proposing to add a new paragraph (d)(4) to Sec. 410.32 to 
provide that, except in limited and specified circumstances as 
described below, we will not deny a claim for services that exceed 
utilization parameters without reviewing all relevant documentation 
submitted with the claim (for example, justifications prepared by 
providers or suppliers, primary and secondary diagnoses, and copies of 
medical records). We, however, may automatically deny a claim without 
any manual review under the following circumstances: (1) If a national 
coverage decision or policy or LMRP review policy specifies the 
circumstances under which a service is denied and those circumstances 
exist, or the service is specifically excluded from Medicare coverage 
by statute; or (2) if we determine that a specific provider or supplier 
has engaged in egregious overutilization of a particular service and 
the claim is for that service.
3. Notice to Beneficiaries
    The Committee discussed the impact of frequency screens on 
laboratories furnishing services to beneficiaries who use multiple 
laboratories. Several Committee members suggested proposals for 
notifying beneficiaries of frequency denials and requesting that they 
advise their physicians of the denial in an effort to encourage the 
physician to obtain an advance beneficiary notice. Such a notification 
mechanism would be costly to Medicare, would frequently and 
inaccurately identify potential denial situations due to time lags 
between

[[Page 13091]]

receipt of services, and may be confusing to beneficiaries. Some 
members of the Committee expressed concern that such a mechanism may 
have the unintended effect of beneficiaries failing to receive 
necessary services. The Committee could not agree to a specific 
proposal and therefore we are soliciting new ideas for addressing this 
problem from Committee members as well as others. We are especially 
interested in ideas that include shared responsibility for solving the 
problem.
4. Consistent Remittance Message
    Some Committee Members expressed concern that HCFA may not be using 
a consistent denial message to indicate claims that are denied for 
excess frequency. We agreed to instruct the Medicare claims processing 
contractors (carriers and fiscal intermediaries) to consistently use 
remittance advice language that identifies the reason for denial as 
excessive frequency. The language would read as follows: ``Claim/
service denied/reduced because the payer deems the information 
submitted does not support this level of service, this many services, 
this length of service or this dosage.''

IV. Other Topics Discussed by the Committee

    The Committee also discussed some topics that we identified as 
outside the scope of the negotiations, but are of concern to some 
Committee members. The Committee discussed Medicare provisions on 
limitation of liability (sometimes called waiver of liability) in the 
context of laboratory services. These provisions are currently found in 
section 1879 of the Social Security Act, 42 CFR part 411, subpart K, 
section 7330 of the Medicare Carriers Manual, section 3440--3446.9 of 
the Fiscal Intermediary Manual, and any currently applicable rulings. 
If prerequisites for waiver of liability in these provisions are met, 
these provisions are equally applicable to laboratory services. If we 
issue revisions or clarifications of these policies in the future, the 
revisions would be applicable to all providers/suppliers, including 
laboratories, unless otherwise stated.

V. Provisions of the Proposed Regulations

    This proposed rule would establish uniform national coverage and 
administrative policies for clinical diagnostic laboratory services 
payable under Medicare Part B. This proposed rule would promote 
Medicare program integrity and national uniformity and would 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 changes we would make to 42 CFR part 410 are set 
forth as follows:
     We are proposing to redesignate paragraph (d) introductory 
text as paragraph (d)(1) and adding a heading.
     We are proposing to redesignate paragraphs (d)(1) through 
(d)(7) as paragraphs (d)(1)(i) through (d)(1)(vii).
     We are proposing 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 
proposed 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 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 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 rules and regulations on 
patient confidentiality.
     We are proposing to add a new paragraph (d)(3) to 
Sec. 410.32 relating to claims review.
    + Paragraph (d)(3)(i) would 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) would 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) would 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.
     We are proposing to add a new paragraph (d)(4) to 
Sec. 410.32 to outline when we may deny a claim without manual review.
    + Paragraph (d)(4)(i) would 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) would permit automatic denial of claims when 
there is a national coverage decision, or LMRP that specifies the 
circumstances under which the service is denied, 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.

VI. Effective Date of Provisions

    The Committee discussed the appropriate effective date of the 
provisions for which it reached consensus. Changes or clarifications 
resulting from the Committee's negotiations will impact each entity 
submitting the claim differently (for example, variance in the time 
frame for computer systems and software updates in accordance with this 
proposed regulation, compliance with the comprehensive HIPAA 
administrative simplification regulations, etc.). We especially are 
concerned about smaller entities because of the lack of resources at 
their disposal to identify and implement changes. Due to such 
differences among laboratories and physician offices, the Committee 
recommended that HCFA provide an extended period of advance 
notification prior to implementation. We note that the national 
coverage decisions included in addendum B effect approximately 60 
percent of the total volume of laboratory services billed to the 
Medicare program. The Committee is concerned that there be an adequate 
opportunity to educate the community

[[Page 13092]]

regarding the decisions and their impact upon claims payment. They were 
also concerned that there be adequate opportunity to modify computer 
systems to accommodate these provisions.
    The Committee reached consensus to recommend that changes arising 
from these actions would become effective 12 months after publication 
of the final regulation. Further, it recommended a grace period of not 
more than 12 months after the effective date of the changes be 
available for any system changes any party is required to make. In 
modifying claims processing systems for the proposed changes, we will 
give priority to implementation of the national coverage decisions. We 
are proposing to delay the effective date of this proposed rule and 
national coverage decisions in accordance with the Committee's 
consensus recommendation.
    The Committee also discussed a strategy to communicate the changes 
to affected parties. Many members of the Committee will continue to 
work together in further developing a plan through which they could 
adequately inform the community, especially physicians and 
laboratories, of the provisions of this proposed rule and the national 
coverage decisions. We will instruct the contractors to issue a 
bulletin to notify affected providers, such as physicians, hospitals, 
and laboratories, of the policies. Within 90 days of receiving this 
instruction from us, contractors must issue the bulletin at least 90 
days before the effective date of the policy and national coverage 
decision.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act 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 Paperwork Reduction Act 
of 1995 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.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements:

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 HCFA upon request; 1) documentation of the 
physician's order for the service billed (including information 
sufficient to enable HCFA 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 pursuant to 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 3 copies 
directly to the following:

Health Care Financing Administration, Office of Information Services, 
Standards and Security Group, Division of HCFA Enterprise Standards, 
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850. Attn: 
John Burke HCFA-3250-P
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Allison Eydt, HCFA Desk Officer.

VIII. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, if we proceed with a subsequent 
document, we will respond to the major comments in the preamble to that 
document.

IX. Regulatory Impact Analysis

    We have examined the impacts of this proposed rule as required by 
Executive

[[Page 13093]]

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 603 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area and has fewer than 50 beds.

A. Executive Order 12866

    The intent of this Proposed 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 proposed rule to have a significant cost effect upon 
providers or suppliers. The provisions of the proposed 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 
proposed 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 if these decisions become effective 
unchanged. 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 would result in a cost savings to the 
Medicare program . If an LMRP was more restrictive than an national 
coverage decision, it would 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 proposed national coverage decisions would 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 $100 million. As noted above, we do not 
anticipate that this proposed rule would have a significant cost 
impact. Thus, we certify that this proposed rule would not result in an 
expenditure in any one year by State, local, or tribal governments, in 
the aggregate, or by the private sector of $100 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 or less annually. Intermediaries and carriers, physicians, and 
many laboratories are considered small entities.
    This proposed rule would 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 proposed rule on 
these entities, for the most part, would be positive. As stated above, 
this proposed rule would, for the most part, explicitly state and 
codify existing policies. Having a clear statement of policies would 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 would reduce the 
burden of recordkeeping and reporting on laboratories without 
increasing the burden on physicians.
    Publication of clear and consistent national coverage decisions 
would assist physicians and laboratories in knowing in advance 
situations where 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 would 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 would result in denial of payment in 
situations where payment is presently made. We believe that the 
proposed policies, developed in partnership with the physician and 
laboratory community and based on authoritative evidence, reflect the 
appropriate treatment of

[[Page 13094]]

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 would 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 would be covered by Medicare.
    If Medicare were to fail to implement the policies proposed in the 
rule and addendum, inconsistency among the contractors would continue. 
The inconsistency would cause confusion on the part of laboratories, 
physicians, and beneficiaries in predicting Medicare coverage decisions 
and anticipating documentation needs. In debating the provisions of the 
proposed rule, the Committee considered a broad range of alternatives 
and their impact upon all affected parties. In light of the explicit 
language of section 4554(b) of the BBA to use negotiated rulemaking to 
pursue recommendations relating to the problems of program 
inconsistency, program abuse, and administrative complexity in Medicare 
payment of clinical diagnostic laboratory services, we have not 
independently considered other alternatives. Rather, we have accepted 
the consensus recommendations of the Committee, which included 
representatives of laboratories, physicians, and beneficiaries. Because 
the provisions of this proposed rule have the support of these 
organizations, we do not anticipate adverse reactions to this proposal.
    For these reasons, the Secretary certifies, that this rule would 
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, this 
regulation was reviewed by the Office of Management and Budget.
    We have reviewed this proposed 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 Part 410

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

    For the reasons set forth in the preamble, 42 CFR chapter IV would 
be amended 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. In Sec. 410.32:
    A. Paragraph (d) introductory text is redesignated as paragraph 
(d)(1) and a heading is added;
    B. Paragraphs (d)(1) through (d)(7) are redesignated as paragraphs 
(d)(1)(i) through (d)(1)(vii); and
    C. Paragraphs (d)(2) through (d)(4) 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.
    (B) The documentation that the information that it submitted with 
the claim accurately reflects the information it received from the 
ordering physician.
    (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 
HCFA, the entity submitting the claim must provide the following 
information :
    (A) Documentation of the physician's order for the service billed 
(including information sufficient to enable HCFA to identify and 
contact the ordering physician).
    (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, 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, HCFA 
takes the following actions:
    (A) Provides the ordering physician information sufficient to 
identify the claim being reviewed.
    (B) Requests from the ordering physician those parts of a 
beneficiary's medical record that are relevant to the specific claim(s) 
being reviewed.
    (C) If the ordering physician 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 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, HCFA does not deny a 
claim for services that exceeds utilization parameters without 
reviewing all relevant documentation submitted with the claim (for 
example, justifications prepared by providers, primary and secondary 
diagnoses, and copies of medical records).
    (ii) Exceptions. HCFA may automatically deny a claim without manual 
review under the following circumstances:
    (A) 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 statute.
    (B) HCFA determines that a specific provider or supplier has 
engaged in egregious overutilization of a particular service, and the 
claim is for that service.


[[Page 13095]]


(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

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


    Dated: July 9, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
    Dated: November 24, 1999.
Donna E. Shalala,
Secretary.

    Note: The following addendums A-C will not appear in the Code of 
Federal Regulations.


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. HCFA 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 HCFA'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.

National Coverage Policy For

    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).

Descriptor(s)

    The descriptor(s) used in this section is (are) the Current 
Procedural Terminology (CPT) or other HCFA 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

Code:      Description

    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 HCFA policy.

ICD-9-CM Codes Denied

Code:      Description

    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

Code:      Description

    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.''

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.

[[Page 13096]]

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 be 
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 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.

[[Page 13097]]

 
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).
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 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

[[Page 13098]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995).

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

Code:       Descriptor

    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

[[Page 13099]]

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 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
----------------------------------------------------------------------------------------------------------------
87536...............................................  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 antiretroviral 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 
antiretroviral 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.
----------------------------------------------------------------------------------------------------------------


[[Page 13100]]

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 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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
DV16.4..............................................  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

Code:      Description

    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

[[Page 13101]]

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. (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 which 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 
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,

[[Page 13102]]

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.
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.

[[Page 13103]]

 
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.
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.................................................  Pneumococcal pneumonia.
 482.0-482.9........................................  Other bacterial pneumonia.
484.1...............................................  Pneumonia in cytomegalic inclusion disease.
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-.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.

[[Page 13104]]

 
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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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).

[[Page 13105]]

 
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

Code:      Description

    Any ICD-9-CM code not listed in neither 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.

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).

[[Page 13106]]

 
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 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

Code:      Description

    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

[[Page 13107]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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.

[[Page 13108]]

 
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.
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.

[[Page 13109]]

 
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.
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 editiion, 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

[[Page 13110]]

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.

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
----------------------------------------------------------------------------------------------------------------
002.0-002.9.........................................  Typhoid and paratyphoid.
003.0-003.9.........................................  Other Salmonella infections.
042.................................................  Human immunodeficiency virus (HIV) disease.
038.9...............................................  Unspecified Septicemia.
060.0-060.9.........................................  Yellow fever.
65.0-065.9..........................................  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.

[[Page 13111]]

 
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.
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-.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.
362.34..............................................  Amaurosis fugax.
362.43..............................................  Hemorrhagic detachment of 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.
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.
459.89..............................................  Ecchymosis.
530.7...............................................  Gastroesophageal laceration--hemorrhage syndrome.
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 13112]]

 
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-.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-.9............................................  Fetal and neonatal hemorrhage.
774.0-.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.
786.59..............................................  Chest pain.
789.00-.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-.99..........................................  Other fracture, skull.
804.00-.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-.9............................................  Fracture of pelvis.
809.0-.1............................................  Fracture of trunk.
810.00-.13..........................................  Fracture of clavicle.
811.00-.19..........................................  Fracture of scapula.
812.00-.59..........................................  Fracture of humerus.
813.10-.18..........................................  Fracture of radius and ulna, upper end, open.

[[Page 13113]]

 
813.30-.38..........................................  Fracture of radius and ulna, shaft, open.
813.50-813.58.......................................  Fracture of radius and ulna, lower end, open.
813.90-.98..........................................  Fracture of radius and ulna, unspecified part, open
819.0-819.1.........................................  Multiple fractures.
820.00- 821.39......................................  Femur.
823.00-.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-.32..........................................  Injury to heart and lung.
862.0-.862.9........................................  Injury to other and unspecified intrathoracic organs.
863.0-.9............................................  Injury to gastrointestinal tract.
864.00-.19..........................................  Injury to liver.
865.00-.19..........................................  Injury to spleen.
866.00-.13..........................................  Injury to kidney.
867.0-.9............................................  Injury to pelvic organs.
868.00-.19..........................................  Injury to other intra-abdominal organs.
869.0-.1............................................  Internal injury to unspecified or ill defined organs.
900.00-.9...........................................  Injury to blood vessels of head and neck.
901.0-.9............................................  Injury to blood vessels of the thorax.
902.0-.9............................................  Injury to blood vessels of the abdomen and pelvis.
903.00-.9...........................................  Injury to blood vessels of upper extremity.
904.0-.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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

ICD-9-CM Codes Denied

[[Page 13114]]



----------------------------------------------------------------------------------------------------------------
                        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.
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-9-09-CM Codes That Do Not Support Medical Necessity:

Code: Description

    Any ICD-9-09CM 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, P 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 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.

[[Page 13115]]

    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.
    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.
84.8................................................  Blackwater fever.
120.0...............................................  Schistosomiasis.
121.1...............................................  Clonorchiasos.
121.3...............................................  Fascioliasis.

[[Page 13116]]

 
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.
342.9...............................................  Hemiplegia NOS.
42.90...............................................  Hemiplegia NOS, Side NEC.
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.
374.81..............................................  Hemorrage in optic nerve sheaths.
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.

[[Page 13117]]

 
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.
428.0-428.9.........................................  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.
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 without 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.

[[Page 13118]]

 
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 (5th digits 5, 6, and 9 allowed only).
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.
780.2...............................................  Syncope an 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.

[[Page 13119]]

 
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.
813.10-18...........................................  Fracture of radius and ulna, upper end, open.
813.30-38...........................................  Shaft, open.
813.50-813.58.......................................  Lower end, open.
813.90-98...........................................  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-.32..........................................  Injury to heart and lung.
862.0-.862.9........................................  Injury to other and unspecified intrathoracic organs.
863.0-.9............................................  Injury to gastrointestinal tract.
864.00-.19..........................................  Injury to liver.
865.00-.19..........................................  Injury to spleen.
866.00-.13..........................................  Injury to kidney.
867.0-.9............................................  Injury to pelvic organs.
868.00-.19..........................................  Injury to other intra-abdominal organs.
869.0-.1............................................  Internal injury to unspecified or ill defined organs.
900.00-.9...........................................  Injury to blood vessels of head and neck.
901.0-.9............................................  Injury to blood vessels of the thorax.
902.0-.9............................................  Injury to blood vessels of the abdomen and pelvis.
903.00-.9...........................................  Injury to blood vessels of upper extremity.
904.0-.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.
999.2...............................................  Other vascular complications.
999.8...............................................  Other transfusion reactions.
V08.................................................  Asymptomatic HIV infection.
V12.1...............................................  History of nutritional deficiency.
V12.3...............................................  Personal history of diseases of blood and blood-forming
                                                       organs.
V15.1...............................................  Personal history of surgery to heart and great vessels.
V15.2...............................................  Personal history of surgery of other major organs.
V42.0...............................................  Kidney replaced by transplant.
V42.1...............................................  Heart replaced by transplant.
V42.2...............................................  Heart valve replaced by transplant.
V42.6...............................................  Lung replaced by transplant.
V42.7...............................................  Liver replaced by transplant.
V42.8...............................................  Other specified organ or tissue replaced by transplant.
V43.2...............................................  Heart replaced by other means.
V43.3...............................................  Heart valve replaced by other means.
V43.4...............................................  Blood vessel replaced by other means.
V43.60..............................................  Unspecified joint replaced by other means.
V58.2...............................................  Transfusion of blood products.
V58.61..............................................  Long-term (current) use of anticoagulants.
V72.84..............................................  Pre-operative examination, unspecified.
----------------------------------------------------------------------------------------------------------------


[[Page 13120]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

    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
    Wintrobe's Clinical Hematology 9th Ed. Lea and Febinger 
Harrison's Principles of Internal Medicine, McGraw Hill, 14th Ed., 
1997.
    Diagnostic Tests Handbook, Springhouse Corporation, 1987.
    Hemostasis and Thrombosis: Basic Principles and Clinical 
Practice. Colman, et al editors, J.B. Lippincott, 3rd Edition, 1994, 
pp 896-898 and 1045-1046.
    Disorders of Hemostasis, Ratnoff, Oscar D. and Forbes, Charles 
D., W.B. Saunders Company, 1996.
    Merck Manual of Diagnosis and Therapy, 16th Edition (should be 
replaced with 17th Edition when available in 1999.)
    ``Performance of the Coumatrak System at a Large Anticoagulation 
Clinic''. Coagulation and Transfusion Medicine. January 1995. pp 98-
102.
    ``Monitoring Oral Anticoagulation Therapy with Point-of-Care 
Devices. Correlation and

[[Page 13121]]

Caveats''. Clinical Chemistry: No. 9, 1997, pp 1785-1786.
    ``College of American Pathologists Conference XXXI on Laboratory 
Monitoring of Anticoagulant Therapy''. Arch. Pathol. Lab. Med. Vol. 
122. September 1998. pp 768-780.
    ``A Structured Teaching and Self-management Program for Patients 
Receiving Oral Anti-coagulation''. JAMA; 1999; 281: 145-150.

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.
    6. If a specific condition is known and is the reason for a pre-
operative test, submit the 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.
    7. 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 
(e.g. to report a PT value or re-check need for medication 
adjustment.) Assign code V58.61 to referrals for PT checks or re-
checks. (Reference AHA's Coding Clinic, March-April, pg 12--1987, 
2nd quarter pg 8--1989)

Medicare National Coverage Decision for Serum Iron Studies

Other Names/Abbreviations

Description

    Serum iron studies are useful in the evaluation of disorders of 
iron metabolism, particularly iron deficiency and iron excess. Iron 
studies are best performed when the patient is fasting in the 
morning and has abstained from medications that may influence iron 
balance.
    Iron deficiency is the most common cause of anemia. In young 
children on a milk diet, iron deficiency is often secondary to 
dietary deficiency. In adults, iron deficiency is usually the result 
of blood loss and is only occasionally secondary to dietary 
deficiency or malabsorption. Following major surgery the patient may 
have iron deficient erythropoiesis for months or years if adequate 
iron replacement has not been given. High doses of supplemental iron 
may cause the serum iron to be elevated. Serum iron may also be 
altered in acute and chronic inflammatory and neoplastic conditions.
    Total iron binding capacity (TIBC) is an indirect measure of 
transferrin, a protein that binds and transports iron. TIBC 
quantifies transferrin by the amount of iron that it can bind. TIBC 
and transferrin are elevated in iron deficiency, and with oral 
contraceptive use, and during pregnancy. TIBC and transferrin may be 
decreased in malabsorption syndromes or in those affected with 
chronic diseases. The percent saturation represents the ratio of 
iron to the TIBC.
    Assays for ferritin are also useful in assessing iron balance. 
Low concentrations are associated with iron deficiency and are 
highly specific. High concentrations are found in hemosiderosis 
(iron overload without associated tissue injury) and hemochromatosis 
(iron overload with associated tissue injury). In these conditions 
the iron is elevated, the TIBC and transferrin are within the 
reference range or low, and the percent saturation is elevated. 
Serum ferritin can be useful for both initiating and monitoring 
treatment for iron overload.
    Transferrin and ferritin belong to a group of serum proteins 
known as acute phase reactants, and are increased in response to 
stressful or inflammatory conditions and also can occur with 
infection and tissue injury due to surgery, trauma or necrosis. 
Ferritin and iron/TIBC (or transferrin) are affected by acute and 
chronic inflammatory conditions, and in patients with these 
disorders, tests of iron status may be difficult to interpret.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82728...............................................  Ferritin.
83540...............................................  Iron.
83550...............................................  Iron Binding capacity.
84466...............................................  Transferrin.
----------------------------------------------------------------------------------------------------------------

Indications

    1. Ferritin (82728), iron (83540) and either iron binding 
capacity (83550) or transferrin (84466) are useful in the 
differential diagnosis of iron deficiency, anemia, and for iron 
overload conditions.
    A. The following presentations are examples that may support the 
use of these studies for evaluating iron deficiency:
     Certain abnormal blood count values (i.e., decreased 
mean corpuscular volume (MCV), decreased hemoglobin/hematocrit when 
the MCV is low or normal, or increased red cell distribution width 
(RDW) and low or normal MCV).
     Abnormal appetite (pica)
     Acute or chronic gastrointestinal blood loss
     Hematuria
     Menorrhagia
     Malabsorption
     Status post-gastrectomy
     Status post-gastrojejunostomy
     Malnutrition
     Preoperative autologous blood collection(s)
     Malignant, chronic inflammatory and infectious 
conditions associated with anemia which may present in a similar 
manner to iron deficiency anemia
     Following a significant surgical procedure where blood 
loss had occurred and had not been repaired with adequate iron 
replacement.
    B. The following presentations are examples that may support the 
use of these studies for evaluating iron overload:
     Chronic Hepatitis
     Diabetes
     Hyperpigmentation of skin
     Arthropathy
     Cirrhosis
     Hypogonadism
     Hypopituitarism
     Impaired porphyrin metabolism

[[Page 13122]]

     Heart failure
     Multiple transfusions
     Sideroblastic anemia
     Thalassemia major
     Cardiomyopathy, cardiac dysrhythmias and conduction 
distrubances
    2. Follow-up testing may be appropriate to monitor response to 
therapy, e.g., oral or parenteral iron, ascorbic acid, and 
erythropoietin.
    3. Iron studies may be appropriate in patients after treatment 
for other nutritional deficiency anemias, such as folate and vitamin 
B12, because iron deficiency may not be revealed until such a 
nutritional deficiency is treated.
    4. Serum ferritin may be appropriate for monitoring iron status 
in patients with chronic renal disease with or without dialysis.
    5. Serum iron may also be indicated for evaluation of toxic 
effects of iron and other metals (e.g., nickel, cadmium, aluminum, 
lead) whether due to accidental, intentional exposure or metabolic 
causes.

Limitations

    1. Iron studies should be used to diagnose and manage iron 
deficiency or iron overload states. These tests are not to be used 
solely to assess acute phase reactants where disease management will 
be unchanged. For example, infections and malignancies are 
associated with elevations in acute phase reactants such as 
ferritin, and decreases in serum iron concentration, but iron 
studies would only be medically necessary if results of iron studies 
might alter the management of the primary diagnosis or might warrant 
direct treatment of an iron disorder or condition.
    2. If a normal serum ferritin level is documented, repeat 
testing would not ordinarily be medically necessary unless there is 
a change in the patient's condition, and ferritin assessment is 
needed for the ongoing management of the patient. For example, a 
patient presents with new onset insulin-dependent diabetes mellitus 
and has a serum ferritin level performed for the suspicion of 
hemochromatosis. If the ferritin level is normal, the repeat 
ferritin for diabetes mellitus would not be medically necessary.
    3. When an End Stage Renal Disease (ESRD) patient is tested for 
ferritin, testing more frequently than every three months (the 
frequency authorized by 3167.3, Fiscal Intermediary 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)].
    4. It is ordinarily not necessary to measure both transferrin 
and TIBC at the same time because TIBC is an indirect measure of 
transferrin. When transferrin is ordered as part of the nutritional 
assessment for evaluating malnutrition, it is not necessary to order 
other iron studies unless iron deficiency or iron overload is 
suspected as well.
    5. It is not ordinarily necessary to measure both iron/TIBC (or 
transferrin) and ferritin in initial patient testing. If clinically 
indicated after evaluation of the initial iron studies, it may be 
appropriate to perform additional iron studies either on the initial 
specimen or on a subsequently obtained specimen. After a diagnosis 
of iron deficiency or iron overload is established, either iron/TIBC 
(or transferrin) or ferritin may be medically necessary for 
monitoring, but not both.
    6. It would not ordinarily be considered medically necessary to 
do a ferritin as a preoperative test except in the presence of 
anemia or recent autologous blood collections prior to the surgery.

ICD-9-CM Codes Covered by Medicare Program

------------------------------------------------------------------------
             Code                             Description
------------------------------------------------------------------------
002.0-002.9..................  Typhoid and paratyphoid fevers.
003.0-003.9..................  Other salmonella infections.
006.0-006.9..................  Amebiasis.
007.0-007.9..................  Other protozoal intestinal diseases.
008.00-008.8.................  Intestinal infections due to other
                                organisms.
009.0-009.3..................  Ill-defined intestinal infections.
011.50-011.56................  Tuberculous bronchiectasis.
014.00-014.86................  Tuberculosis of intestines, peritoneum,
                                and mesenteric glands.
015.00-015.96................  Tuberculosis of bones and joints.
016.00-016.06................  Tuberculosis of kidney.
016.10-016.16................  Tuberculosis of bladder.
016.20-016.26................  Tuberculosis of ureter.
016.30-016.36................  Tuberculosis of other urinary organs.
042..........................  Human Immunodeficiency virus (HIV)
                                disease.
070.0-070.9..................  Viral hepatitis.
140.0-149.9..................  Malignant neoplasm of lip oral cavity and
                                pharynx.
150.0-159.9..................  Malignant neoplasm of digestive organs
                                and peritoneum.
160.0-165.9..................  Malignant neoplasm of respiratory and
                                intrathoracic organs.
170.0-176.9..................  Malignant neoplasm of bone, connective
                                tissue, skin and breast.
179-189.9....................  Malignant neoplasm of genitourinary
                                organs.
190.0-199.1..................  Malignant neoplasm of other and
                                unspecified sites.
200.0-208.91.................  Malignant neoplasm of lymphatic and
                                hematopoietic tissue.
210.0-229.9..................  Benign neoplasms.
230.0-234.9..................  Carcinoma in situ.
235.0-238.9..................  Neoplasms of uncertain behavior.
239.0-239.9..................  Neoplasms of unspecified nature.
250.00-250.93................  Diabetes mellitus.
253.2........................  Panhypopituitarism.
253.7........................  Iatrogenic pituitary disorders.
253.8........................  Other disorders of the pituitary and
                                other syndromes of
                                diencephalohypophyseal origin.
256.3........................  Other ovarian failure.
257.2........................  Other testicular hypofunction.
260..........................  Kwashiorkor.
261..........................  Nutritional marasmus.
262..........................  Other severe protein-calorie
                                malnutrition.
263.0-263.9..................  Other and unspecified protein-calorie
                                malnutrition.
275.0........................  Disorders of iron metabolism.
277.1........................  Disorders of porphyrin metabolism.
280.0-280.9..................  Iron deficiency anemias.
281.0-281.9..................  Other deficiency anemias.
282.4........................  Thalassemias.
285.0........................  Sideroblastic anemia (includes
                                hemochromatosis with refractory anemia).
285.1........................  Acute post-hemorrhagic anemia.

[[Page 13123]]

 
285.9........................  Anemia, unspecified.
286.0-286.9..................  Coagulation defects (congenital factor
                                disorders).
287.0-287.9..................  Purpura and other hemorrhagic conditions.
306.4........................  Physiological malfunction arising from
                                mental factors, gastrointestinal.
307.1........................  Anexoria nervosa.
307.50-307.59................  Other and unspecified disorders of
                                eating.
425.4........................  Other primary cardiomyopathies.
425.5........................  Alcoholic cardiomyopathy.
425.7........................  Nutritional and metabolic cardiomyopathy.
425.8........................  Cardiomyopathy in other diseases
                                classified elsewhere.
425.9........................  Secondary cardiomyopathy, unspecified.
426.0-426.9..................  Conduction disorders.
427.0-427.9..................  Cardiac dysrhythmias.
428.0-428.9..................  Heart Failure.
530.7........................  Gastroesophageal laceration-hemorrhage
                                syndrome.
530.82.......................  Esophageal hemorrhage.
531.00-531.91................  Gastric ulcer.
532.00-532.91................  Duodenal ulcer.
533.00-533.91................  Peptic ulcer, site unspecified.
534.00-534.91................  Gastrojejunal ulcer.
535.00-535.61................  Gastritis and duodenitis.
536.0-536.9..................  Disorders of function of stomach.
537.83.......................  Angiodysplasia of stomach and duodenum
                                with hemorrhage.
555.0-555.9..................  Regional enteritis.
556.0-556.9..................  Ulcerative colitis.
557.0........................  Acute vascular insufficiency of
                                intestine.
557.1........................  Chronic vascular insufficiency of
                                intestine.
562.02.......................  Diverticulosis of small intestine with
                                hemorrhage.
562.03.......................  Diverticulitis of small intestine with
                                hemorrhage.
562.12.......................  Diverticulosis of colon with hemorrhage.
562.13.......................  Diverticulitis of colon with hemorrhage.
569.3........................  Hemorrhage of rectum and anus.
569.85.......................  Angiodysplasia of intestine with
                                hemorrhage.
570..........................  Acute and subacute necrosis of liver.
571.0-571.9..................  Chronic liver disease and cirrhosis.
572.0-572.8..................  Liver abscess and sequelae of chronic
                                liver disease.
573.0-573.9..................  Other disorders of liver.
578.0-578.9..................  Gastrointestinal hemorrhage.
579.0-579.3..................  Intestinal malabsorption.
581.0-581.9..................  Nephrotic syndrome.
585..........................  Chronic renal failure.
586..........................  Renal failure, unspecified.
608.3........................  Atrophy of testis.
626.0-626.9..................  Disorders of menstruation and other
                                abnormal bleeding from female genital
                                tract.
627.0........................  Premenopausal menorrhagia.
627.1........................  Postmenopausal bleeding.
648.20-648.24................  Other current conditions in the mother
                                classifiable elsewhere, but complicating
                                pregnancy, childbirth, or the
                                puerperium: Anemia.
698.0-698.9..................  Pruritis and related conditions.
704.00-704.09................  Alopecia.
709.00-709.09................  Dyschromia.
719.40-719.49................  Pain in joint.
773.2........................  Hemolytic disease due to other and
                                unspecified isoimmunization.
773.3........................  Hydrops fetalis due to isoimmunization.
773.4........................  Kernicterus due to isoimmunization.
773.5........................  Late anemia due to isoimmunization.
783.9........................  Other symptoms concerning nutrition,
                                metabolism and development.
790.0........................  Abnormality of red blood cells.
790.4........................  Nonspecific elevation of levels of
                                transaminase or lactic acid
                                dehydrogenase [LDH].
790.5........................  Other nonspecific abnormal serum
                                enzymelevels.
790.6........................  Other abnormal blood chemistry.
799.4........................  Cachexia.
964.0........................  Poisoning by agents primarily affecting
                                blood constituents, iron compounds.
984.0-984.9..................  Toxic effect of lead and its compounds
                                (including fumes).
996.85.......................  Complications of transplanted organ, bone
                                marrow.
999.8........................  Other transfusion reaction.
V08..........................  Asymptomatic HIV infection.
V12.1........................  Personal history of nutritional
                                deficiency.
V12.3........................  Personal history of diseases of blood and
                                blood forming organs.
V15.1........................  Personal history of surgery to heart and
                                great vessels.
V15.2........................  Personal history of surgery to other
                                major organs.
V43.2........................  Heart replaced by other means.
V43.3........................  Heart valve replaced by other means.
V43.4........................  Blood vessel replaced by other means.

[[Page 13124]]

 
V43.60.......................  Unspecified joint replaced by other
                                means.
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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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
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.
----------------------------------------------------------------------------------------------------------------


[[Page 13125]]

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

Code:      Description

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

Sources of Information

    CDC. Recommendations to prevent and control iron deficiency in 
the United States. MMWR 1998; 47(RR-3):1-29.
    Powell LW, George DK, McDonnell SM, Kowdley KV. Diagnosis of 
hemochromatosis. Ann.Intern.Med. 1998; 129:925-931.
    Spiekerman AM. Proteins used in nutritional assessment. 
Clin.Lab.Med. 1993; 13:353-369.
    Wallach JB. Handbook of Interpretation of Diagnostic Tests. 
Lippincott-Raven Publishers (Philadelphia) 1998, pp. 170-180.
    Van Walraven C, Goel V, Chan B. Effect of Population-Based 
Interventions on Laboratory Utilization. JAMA. 1998; 280:2028-2033.
    Guyatt GH, Patterson C, Ali M, Singer J, Levine M, Turpie I, 
Meyer R. Diagnosis of Iron-Deficiency Anemia in the Elderly. AmJMed. 
1990; 88:205-209.
    Burns ER, Goldberg SN, Lawrence C, Wenz B. AJCP. 1990; 3:240-
245.

Burns ER, et al. Brief Clinical Observations. AmJMed. 1991; 90:653-654.

    Yang Q, et al. Hemochromatosis-associated Mortality in the 
United States from 1979 to 1992: An Analysis of Multiple-Cause 
Mortality Data. AnIntMed. 1998; 129:946-953.

Coding Guidelines:

    1. Any claim for a test listed in AHCPCS CODES@ above must be 
submitted with an ICD-9-CM diagnosis code or comparable narrative. 
ICD-9-CM code V82.9 (special screening of other conditions, 
unspecified condition), or comparable narratives should be used to 
indicate screening tests performed in the absence of a specific 
sign, symptom, or complaint. Use of V82.9 or comparable narrative 
will result in the denial of claims as non covered screening 
services. (Note: this language may be inappropriate for screening 
tests that are specifically covered by statute, such as pap smears.) 
All ICD-9-CM diagnosis codes must be coded to the highest level of 
specificity.
    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 or fifth-digit classifications are 
provided, they must be assigned. 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 nonspecific 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 Collagen Crosslinks, Any 
Method

Other Names/Abreviations

Description

    Collagen crosslinks, part of the matrix of bone upon which bone 
mineral is deposited, are biochemical markers the excretion of which 
provide a quantitative measurement of bone resorption. Elevated 
levels of urinary collagen crosslinks indicate elevated bone 
resorption. Elevated bone resorption contributes to age-related and 
postmenopausal loss of bone leading to osteoporosis and increased 
risk of fracture. The collagen crosslinks assay can be performed by 
immunoassay or by high performance liquid chromatography (HPLC). 
Collagen crosslink immunoassays measure the pyridinoline crosslinks 
and associated telopeptides in urine.
    Bone is constantly undergoing a metabolic process called 
turnover or remodeling. This includes a degradation process, bone 
resorption, mediated by the action of osteoclasts, and a building 
process, bone formation, mediated by the action of osteoblasts. 
Remodeling is required for the maintenance and overall health of 
bone and is tightly coupled; that is, resorption and formation must 
be in balance. In abnormal states of bone remodeling, when 
resorption exceeds formation, it results in a net loss of bone. The 
measurement of specific, bone-derived resorption products provides 
analytical data about the rate of bone resorption.
    Osteoporosis is a condition characterized by low bone mass and 
structural deterioration of bone tissue, leading to bone fragility 
and an increased susceptibility to fractures of the hip, spine, and 
wrist. The term primary osteoporosis is applied where the causal 
factor in the disease is menopause or aging. The term secondary 
osteoporosis is applied where the causal factor is something other 
than menopause or aging, such as long-term administration of 
glucocorticosteroids, endocrine-related disorders (other than loss 
of estrogen due to menopause), and certain bone diseases such as 
cancer of the bone.
    With respect to quantifying bone resorption, collagen crosslink 
tests can provide adjunct diagnostic information in concert with 
bone mass measurements. Bone mass measurements and biochemical 
markers may have complementary roles to play in assessing 
effectiveness of osteoporosis treatment. Proper management of 
osteoporosis patients, who are on long-term therapeutic regimens, 
may include laboratory testing of biochemical markers of bone 
turnover, such as collagen crosslinks, that provide a profile of 
bone turnover responses within weeks of therapy. Changes in collagen 
crosslinks are determined following commencement of antiresorptive 
therapy. These can be measured over a shorter time interval, such as 
three months, when compared to bone mass density. If bone resorption 
is not elevated, repeat testing is not medically necessary.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82523...............................................  Collagen cross links, any method.
----------------------------------------------------------------------------------------------------------------

Indications

    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. Coverage for bone marker assays may be 
established, however, for younger Medicare beneficiaries and for 
those who might become fast losers because of some other therapy 
such as glucocorticoids. Safeguards should be incorporated to 
prevent excessive use of tests in patients for whom they have no 
clinical relevance.
    Collagen crosslinks testing is used to:
     identify individuals with elevated bone resorption, who 
have osteoporosis in whom response to treatment is being monitored;
     predict response (as assessed by bone mass 
measurements) to FDA approved antiresorptive therapy in 
postmenopausal women;
     assess response to treatment of patients with 
osteoporosis, Paget's disease of the bone, or risk for osteoporosis 
where

[[Page 13126]]

treatment may include FDA approved antiresorptive agents, anti-
estrogens or selective estrogen receptor moderators.

Limitations

    Because of significant specimen to specimen collagen crosslink 
physiologic variability (15-20%), current recommendations for 
appropriate utilization include: one or two base-line assays from 
specified urine collections on separate days; followed by a repeat 
assay about three months after starting anti-resorptive therapy; 
followed by a repeat assay in 12 months after the three-month assay; 
and thereafter not more than annually, unless there is a change in 
therapy in which circumstance an additional test may be indicated 
three months after the initiation of new therapy.
    Some collagen crosslink assays may not be appropriate for use in 
some disorders, according to FDA labeling restrictions.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
203.00-.01..........................................  Multiple myeloma.
242.00-242.91.......................................  Thyrotoxicosis.
245.2...............................................  Chronic lymphocytic thyroiditis (only if thyrotoxic).
246.9...............................................  Unspecified disorder of thyroid.
252.0...............................................  Hyperparathyroidism.
256.2...............................................  Postablative ovarian failure.
256.3...............................................  Other ovarian failure.
256.8...............................................  Other ovarian dysfunction.
256.9...............................................  Unspecified ovarian dysfunction.
268.9...............................................  Unspecified vitamin D deficiency.
269.3...............................................  Mineral deficiency, not elsewhere classified.
627.0...............................................  Premenopausal menorrhagia.
627.1...............................................  Postmenopausal bleeding.
627.2...............................................  Menopausal or female climacteric state.
627.4...............................................  States associated with artificial menopause.
627.8...............................................  Other specified menopausal and postmenopausal disorders.
627.9...............................................  Unspecified menopausal & postmenopausal disorder.
731.0...............................................  Osteitis deformans without mention of bone tumor (Paget's
                                                       disease of bone).
733.00-733.09.......................................  Osteoporosis
733.10-733.19.......................................  Pathological fracture
733.90..............................................  Disorder of bone and cartilage, unspecified
805.8...............................................  Fracture of vertebral column without mention of spiral
                                                       cord injury, unspecified, closed
V58.69..............................................  Long-term (current) use of other medications.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
V18.0-V18.8.........................................  Family history of certain other specific conditions.
V19.0-V19.8.........................................  Family history of other conditions.

[[Page 13127]]

 
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

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

Sources of Information

    Arnaud CD. Osteoporosis: Using `bone markers' for diagnosis and 
monitoring. Geriatrics 1996; 51:24-30.
    Chesnut CH, III, Bell NH, Clark G, et al. Hormone replacement 
therapy in postmenopausal women: urinary N-telopeptide of type I 
collagen monitors therapeutic effect and predicts response of bone 
mineral density. Am. J. Med. 1997; 102:29-37.
    Garnero P, Delmas PD. Clinical usefulness of markers of bone 
remodelling in osteoporosis. In: Meunier PJ (ed). 
Osteoporosis:diagnosis and management. London: Martin Dunitz Ltd. 
1998:79-101.
    Garnero P, Shih WJ, Gineyts E, et al. Comparison of new 
biochemical markers of bone turnover in late postmenopausal 
osteoporotic women in response to alendronate treatment. J. Clin. 
Endocrinol. Metab. 1994; 79:1693-700.
    Harper KD, Weber TJ. Secondary osteoporosis--Diagnostic 
considerations. Endocrinol. Metab.Clin. North Am. 1998;27:325-48.
    Hesley RP, Shepard KA, Jenkins DK, Riggs BL. Monitoring estrogen 
replacement therapy and identifying rapid bone losers with an 
immunoassay for deoxypyridinoline. Osteoporos. Int. 1998;8:159-64.
    Melton LJ, III, Khosla S, Atkinson EJ, et al. Relationship of 
bone turnover to bone density and fractures. J.Bone Miner. Res.1997; 
12:1083-91.
    Millard PS. Prevention of osteoporosis: making sense of the 
published evidence. In: Rosen CJ (ed). Osteoporosis: diagnostic and 
therapeutic principles. Totowa: Humana Press Inc. 1996:275-85.
    Rosen CJ. Biochemical markers of bone turnover. In: Rosen 
CJ(ed). Osteoporosis: diagnostic and therapeutic principles. Totowa: 
Humana Press Inc. 1996:129-41.
    Schneider DL, Barrett-Connor EL. Urinary N-Telopeptide levels 
discriminate normal, osteopenic, and osteoporotic bone mineral 
density. Arch. Intern. Med. 1997; 157:1241-5.

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. When the indication for the test is long-term administration 
of glucocorticosteroids, use ICD-9-CM code V58.69.

Medicare National Coverage Decision for Blood Glucose Testing

Description

    This policy is intended to apply to blood samples used to 
determine glucose levels.
    Blood glucose determination may be done using whole blood, serum 
or plasma. It may be sampled by capillary puncture, as in the 
fingerstick method, or by vein puncture or arterial sampling. The 
method for assay may be by color comparison of an indicator stick, 
by meter assay of whole blood or a filtrate of whole blood, using a 
device approved for home monitoring, or by using a laboratory assay 
system using serum or plasma. The convenience of the meter or stick 
color method allows a patient to have access to blood glucose values 
in less than a minute or so and has become a standard of care for 
control of blood glucose, even in the inpatient setting.

HCPCS Codes (Alpha numeric, CPT  AMA):

[[Page 13128]]



----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82947...............................................  Glucose; quantitative.
82948...............................................  Glucose; blood, reagent strip.
82962...............................................  Glucose, blood by glucose monitoring device(s) cleared by
                                                       the FDA specifically for home use.
----------------------------------------------------------------------------------------------------------------

Indications

    Blood glucose values are often necessary for the management of 
patients with diabetes mellitus, where hyperglycemia and 
hypoglycemia are often present. They are also critical in the 
determination of control of blood glucose levels in the patient with 
impaired fasting glucose (FPG 110-125 mg/dL), the patient with 
insulin resistance syndrome and/or carbohydrate intolerance 
(excessive rise in glucose following ingestion of glucose or glucose 
sources of food), in the patient with a hypoglycemia disorder such 
as nesidioblastosis or insulinoma, and in patients with a catabolic 
or malnutrition state. In addition to those conditions already 
listed, glucose testing may be medically necessary in patients with 
tuberculosis, unexplained chronic or recurrent infections, 
alcoholism, coronary artery disease (especially in women), or 
unexplained skin conditions (including pruritis, local skin 
infections, ulceration and gangrene without an established cause). 
Many medical conditions may be a consequence of a sustained elevated 
or depressed glucose level. These include comas, seizures or 
epilepsy, confusion, abnormal hunger, abnormal weight loss or gain, 
and loss of sensation. Evaluation of glucose may also be indicated 
in patients on medications known to affect carbohydrate metabolism.

Limitations

    Frequent home blood glucose testing by diabetic patients should 
be encouraged. In stable, non-hospitalized patients who are unable 
or unwilling to do home monitoring, it may be reasonable and 
necessary to measure quantitative blood glucose up to four times 
annually.
    Depending upon the age of the patient, type of diabetes, degree 
of control, complications of diabetes, and other co-morbid 
conditions, more frequent testing than four times annually may be 
reasonable and necessary.
    In some patients presenting with nonspecific signs, symptoms, or 
diseases not normally associated with disturbances in glucose 
metabolism, a single blood glucose test may be medically necessary. 
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 specific diagnosis code (e.g., diabetes) 
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 confirmed continuing risk of glucose 
metabolism abnormality (e.g., monitoring glucocorticoid therapy).

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
011.00-011.96.......................................  Tuberculosis.
038.0-038.9.........................................  Septicemia.
112.1...............................................  Recurrent vaginal candidiasis.
112.3...............................................  Interdigital candidiasis.
118.................................................  Opportunistic mycoses.
157.4...............................................  Malignant neoplasm of Islets of Langerhans.
158.0...............................................  Malignant neoplasm of retroperitoneum.
211.7...............................................  Benign neoplasm of Islets of Langerhans.
242.00-242.91.......................................  Thyrotoxicosis.
250.00-250.93.......................................  Diabetes mellitus.
251.0-251.9.........................................  Disorders of pancreatic internal secretion.
253.0-253.9.........................................  Disorders of the pituitary gland.
255.0...............................................  Cushing syndrome.
263.0-263.9.........................................  Malnutrition.
271.0-271.9.........................................  Disorders of carbohydrate transport and metabolism.
272.0-272-4.........................................  Disorders of lipoid metabolism.
275.0...............................................  Hemochromotosis.
276.0-276.9.........................................  Disorders of fluid, electrolyte and acid-base balance.
278.3...............................................  Hypercarotinemia.
293.0...............................................  Acute delirium.
294.9...............................................  Unspecified organic brain syndrome.
298.9...............................................  Unspecified psychosis.
300.9...............................................  Unspecified neurotic disorder.
310.1...............................................  Organic personality syndrome.
337.9...............................................  Autonomic nervous system neuropathy.
345.10-345.11.......................................  Generalized convulsive epilepsy.
348.3...............................................  Encephalopathy, unspecified.
355.9...............................................  Neuropathy, not otherwise specified.
356.9...............................................  Unspecified hereditary and idiopathic peripheral
                                                       neuropathy.
357.9...............................................  Unspecified inflammatory and toxic neuropathy.
362.10..............................................  Background retinopathy.
362.18..............................................  Retinal vasculitis.
362.29..............................................  Nondiabetic proliferative retinopathy.
362.50-362.57.......................................  Degeneration of macular posterior pole.
362.60-362.66.......................................  Peripherial retinal degeneration.
362-81-362.89.......................................  Other retinal disorders.
362.0...............................................  Unspecified retinal disorders.
365.-04.............................................  Borderline glaucoma.
365.32..............................................  Corticosteriod-induced glaucoma residual.
366.00-366.09.......................................  Presenile cataract.
366.10-366.19.......................................  Senile cataract.
367.1...............................................  Acute myopia.
368.8...............................................  Other specified visual disturbance.

[[Page 13129]]

 
373.00..............................................  Blepharitis.
377.24..............................................  Pseudopapilledema.
377.9...............................................  Autonomic nervous system neuropathy.
378.50-378.55.......................................  Paralytic strabiamus.
379.45..............................................  Argyll-Robertson pupils.
410.00-410.92.......................................  Acute myocardial infarctions.
414.00-414.19.......................................  Coronary atherosclerosis and aneurysm of heart.
425.9...............................................  Secondary cardiomyopathy, unspecified.
440.23..............................................  Arteriosclerosis of extremities with ulceration.
440.24..............................................  Arteriosclerosis of extremities with gangrene.
440.9...............................................  Arteriosclerosis, not otherwise specified.
458.0...............................................  Postural hypotension.
462.................................................  Acute pharyngitis.
466.0...............................................  Acute bronchitis.
480.0-486...........................................  Pneumonia.
490.................................................  Recurrent bronchitis, not specified as acute or chronic.
491.0-491.9.........................................  Chronic bronchitis.
527.7...............................................  Disturbance of salivory secretion (drymouth).
528.0...............................................  Stomatitis.
535.50-535.51.......................................  Gastritis.
536.8...............................................  Dyspepsia.
571.8...............................................  Other chronic nonalcoholic liver disease.
572.0-.8............................................  Liver abscess and sequelae of chronic liver disease.
574.50-574.51.......................................  Choledocholitiasis.
575.0-575.12........................................  Cholecystitis.
576.1...............................................  Cholangitis.
577.0...............................................  Acute pancreatitis.
577.1...............................................  Chronic pancreatitis.
577.8...............................................  Pancreatic multiple calculi.
590.00-590.9........................................  Infections of the kidney.
595.9...............................................  Recurrent cystitis.
596.4...............................................  Bladder atony.
596.53..............................................  Bladder paresis.
599.0...............................................  Urinary tract infection, recurrent.
607.84..............................................  Impotence of organic origin.
608.89..............................................  Other disorders male genital organs.
616.10..............................................  Vulvovaginitis.
626.0...............................................  Amenorrhea.
626.4...............................................  Irregular menses.
628.9...............................................  Infertility--female.
648.00..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, unspecified as to episode of care or not
                                                       applicable.
648.03..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, antipartum condition or complication.
648.04..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, postpartum condition or complication.
648.80..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, unspecified as to episode
                                                       of care or not applicable.
648.83..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, antipartum condition or
                                                       complication.
648.84..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, postpartum condition or
                                                       complication.
656.60-656.63.......................................  Fetal problems affecting management of mother--large for-
                                                       date of fetus.
657.00-657.03.......................................  Polyhydramnios.
680.0-680.9.........................................  Carbuncle and furuncle.
686.00-686.9........................................  Infections of skin and subcutaneous tissue.
698.0...............................................  Pruritis ani.
698.1...............................................  Pruritis of genital organs.
704.1...............................................  Hirsutism.
705.0...............................................  Anhidrosis.
707.0-707.9.........................................  Chronic ulcer of skin.
709.3...............................................  Degenerative skin disorders.
729.1...............................................  Myalgia.
730.07-730.27.......................................  Osteomyelitis of tarsal bones.
780.01..............................................  Coma.
780.02..............................................  Transcient alteration of awareness.
780.09..............................................  Alteration of consciousness, other.
780.2...............................................  Syncope and collapse.
780.39..............................................  Seizures, not otherwise specified.
780.4...............................................  Dizziness and giddiness.
780.71-.79..........................................  Malaise and fatigue.
780.8...............................................  Hyperhidrosis.
782.0...............................................  Loss of vibratory sensation.
783.1...............................................  Abnormal weight gain.
783.2...............................................  Abnormal loss of weight.
783.5...............................................  Polydipsia.

[[Page 13130]]

 
785.0...............................................  Tachycardia.
785.4...............................................  Gangrene.
786.01..............................................  Hyperventilation.
786.09..............................................  Dyspnea.
786.50..............................................  Chest pain, unspecified.
787.6...............................................  Fecal incontinence.
787.91..............................................  Diarrhea.
788.41-788.43.......................................  Frequency of urination and polyuria.
789.1...............................................  Hepatomegaly.
790.2...............................................  Abnormal glucose tolerance test.
790.6...............................................  Other abnormal blood chemistry (hyperglycemia).
791.0...............................................  Proteinuria.
791.5...............................................  Glycosuria.
796.1...............................................  Abnormal reflex.
799.4...............................................  Cachexia.
V23.0-.9............................................  Supervision of high risk pregnancy.
V67.2...............................................  Follow-up examination, following chemotherapy.
V67.51..............................................  Follow up examination with high-risk medication not
                                                       elsewhere classified.
V58.69..............................................  Long term current use of other medication.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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.

[[Page 13131]]

 
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

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

Sources of Information

    AACE Guidelines for the Management of Diabetes Mellitus, 
Endocrine Practice (1995)1:149-157.
    Bower, Bruce F. And Robert E. Moore, Endocrine Function and 
Carbohydrates.
    Clinical Laboratory Medicine, Kenneth D. McClatchy, editor. 
Baltimore/Williams & Wilkins, 1994. Pp 321-323.
    Report of the Expert Committee on the Diagnosis and 
Classification of Diabetes Mellitus, Diabetes Care, Volume 20, 
Number 7, July 1997, pages 1183 et seq.
    Roberts, H.J., Difficult Diagnoses. W. B. Saunders Co., pp 69-
70.

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. A diagnostic statement of impaired glucose tolerance must be 
evaluated in the context of the documentation in the medical record 
in order to assign the most accurate ICD-9-CM code. An abnormally 
elevated fasting blood glucose level in the absence of the diagnosis 
of diabetes is classified to Code 790.6--other abnormal blood 
chemistry. If the provider bases the diagnostic statement of 
``impaired glucose tolerance'' on an abnormal glucose tolerance 
test, the condition is classified to 790.2--normal glucose tolerance 
test. Both conditions are considered indications for ordering 
glycated hemoglobin or glycated protein testing in the absence of 
the diagnosis of diabetes mellitus.
    7. When a patient is under treatment for a condition for which 
the tests in this policy are applicable, the ICD-9-CM code that best 
describes the condition is most frequently listed as the reason for 
the test.
    8. When laboratory testing is done solely to monitor response to 
medication, the most accurate ICD-9-CM code to describe the reason 
for the test would be V58.69--long term use of medication.
    9. Periodic follow-up for encounters for laboratory testing for 
a patient with a prior history of a disease, who is no longer under 
treatment for the condition, would be coded with an appropriate code 
from the V67 category--follow-up examination.
    10. According to ICD-9-CM coding conventions, codes that appear 
in italics in the Alphabetic and/or Tabular columns of ICD-9-CM are 
considered manifestation codes that require the underlying condition 
to be coded and sequenced ahead of the manifestation. For example, 
the diagnostic statement, ``thyrotoxic exophthalmos (376.21),'' 
which appears in italics in the tabular listing, requires that the 
thyroid disorder (242.0-242.9) is coded and sequenced ahead of 
thyrotoxic exophthalmos. Therefore, a diagnostic statement that is 
listed as a manifestation in ICD-9-CM must be expanded to include 
the underlying disease in order to accurately code the condition.

Documentation Requirements

    The ordering physician must include evidence in the patient's 
clinical record that an evaluation of history and physical preceded 
the ordering of glucose testing and that manifestations of abnormal 
glucose levels were present to warrant the testing.
    Medicare National Coverage Decision for Glycated Hemoglobin/
glycated Protein 

Description

    The management of diabetes mellitus requires regular 
determinations of blood glucose levels. Glycated hemoglobin/protein 
levels are used to assess long-term glucose control in diabetes. 
Alternative names for these tests include glycated or glycosylated 
hemoglobin or Hgb, hemoglobin glycated or glycosylated protein, and 
fructosamine.
    Glycated hemoglobin (equivalent to hemoglobin A1) refers to 
total glycosylated hemoglobin present in erythrocytes, usually 
determined by affinity or ion-exchange chromatographic methodology. 
Hemoglobin A1c refers to the major component of hemoglobin A1, 
usually determined by ion-exchange affinity chromatography, 
immunoassay or agar gel electrophoresis. Fructosamine or glycated 
protein refers to glycosylated protein present in a serum or plasma 
sample. Glycated protein refers to measurement of the component of 
the specific protein that is glycated usually by colorimetric method 
or affinity chromatography.
    Glycated hemoglobin in whole blood assesses glycemic control 
over a period of 4-8 weeks and appears to be the more appropriate 
test for monitoring a patient who is capable of maintaining long-
term, stable control. Measurement may be medically necessary every 3 
months to determine whether a patient's metabolic control has been 
on average within the target range. More frequent assessments, every 
1-2 months, may be appropriate in the patient whose diabetes regimen 
has been altered to improve control or in whom evidence is present 
that intercurrent events may have altered a previously satisfactory 
level of control (for example, post-major surgery or as a result of 
glucocorticoid therapy). Glycated protein in serum/plasma assesses 
glycemic control over a period of 1-2 weeks. It may be reasonable 
and necessary to monitor glycated protein monthly in pregnant 
diabetic women. Glycated hemoglobin/protein test results may

[[Page 13132]]

be low, indicating significant, persistent hypoglycemia, in 
nesidioblastosis or insulinoma, conditions which are accompanied by 
inappropriate hyperinsulinemia. A below normal test value is helpful 
in establishing the patient's hypoglycemic state in those 
conditions.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82985...............................................  Glycated protein.
83036...............................................  Hemoglobin; glycated.
----------------------------------------------------------------------------------------------------------------

Indications

    Glycated hemoglobin/protein testing is widely accepted as 
medically necessary for the management and control of diabetes. It 
is also valuable to assess hyperglycemia, a history of hyperglycemia 
or dangerous hypoglycemia. Glycated protein testing may be used in 
place of glycated hemoglobin in the management of diabetic patients, 
and is particularly useful in patients who have abnormalities of 
erythrocytes such as hemolytic anemia or hemoglobinopathies.

Limitations

    It is not considered reasonable and necessary to perform 
glycated hemoglobin tests more often than every three months on a 
controlled diabetic patient to determine whether the patient's 
metabolic control has been on average within the target range. It is 
not considered reasonable and necessary for these tests to be 
performed more frequently than once a month for diabetic pregnant 
women. Testing for uncontrolled type one or two diabetes mellitus 
may require testing more than four times a year. The above 
Description Section provides the clinical basis for those situations 
in which testing more frequently than four times per annum is 
indicated, and medical necessity documentation must support such 
testing in excess of the above guidelines.
    Many methods for the analysis of glycated hemoglobin show 
significant interference from elevated levels of fetal hemoglobin or 
by variant hemoglobin molecules. When the glycated hemoglobin assay 
is initially performed in these patients, the laboratory may inform 
the ordering physician of a possible analytical interference. 
Alternative testing, including glycated protein, for example, 
fructosamine, may be indicated for the monitoring of the degree of 
glycemic control in this situation. It is therefore conceivable that 
a patient will have both a glycated hemoglobin and glycated protein 
ordered on the same day. This should be limited to the initial assay 
of glycated hemoglobin, with subsequent exclusive use of glycated 
protein.
    These tests are not considered to be medically necessary for the 
diagnosis of diabetes.

ICD-9-CM Codes Covered by The Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
211.7...............................................  Benign neoplasm of islets of Langerhans.
250.00-250.93.......................................  Diabetes mellitus & various related codes.
251.0...............................................  Hypoglycemic coma.
251.1...............................................  Other specified hypoglycemia.
251.2...............................................  Hypoglycemia unspecified.
251.3...............................................  Post-surgical hypoinsulinemia.
251.4...............................................  Abnormality of secretion of glucagon.
251.8...............................................  Other specified disorders of pancreatic internal
                                                       secretion.
251.9...............................................  Unspecified disorder of pancreatic internal secretion.
258.0-.9............................................  Polyglandular dysfunction.
271.4...............................................  Renal glycosuria.
275.0...............................................  Hemochromatosis.
577.1...............................................  Chronic pancreatitis.
579.3...............................................  Other and unspecified postsurgical nonabsorption.
648.00..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, unspecified as to episode of care or not
                                                       applicable.
648.03..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, antepartum condition or complication.
648.04..............................................  Diabetes mellitus complicating pregnancy, Childbirth or
                                                       the puerperium, postpartum condition or complication.
648.80..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, unspecified as to episode
                                                       of care or not applicable.
648.83..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, antepartum condition or
                                                       complication.
648.84..............................................  Abnormal glucose tolerance complicating pregnancy,
                                                       childbirth or the puerperium, postpartum condition or
                                                       complication.
790.2...............................................  Abnormal glucose tolerance test.
790.6...............................................  Other abnormal blood chemistry (hyperglycemia.)
962.3...............................................  Poisoning by insulin and antidiabetic agents.
V12.2...............................................  Personal history of endocrine, metabolic, and immunity
                                                       disorders.
V58.69..............................................  Long-term use of other medication.
----------------------------------------------------------------------------------------------------------------

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

[[Page 13133]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    Bower, Bruce F. and Robert E. Moore, Endocrine Function and 
Carbohydrates. Clinical Laboratory Medicine, Kenneth D. McClatchy, 
editor. Baltimore/Williams & Wilkins, 1994. pp. 321-323.
    Tests of Glycemia in Diabetes. Diabetes Care. 1/98, 21:Supp. 
1:S69-S71.
    American Association of Clinical Endocrinologists Guidelines for 
the Management of Diabetes Mellitus.
    Dons, Robert F., Endocrine and Metabolic Testing Manual, Third 
Edition. Expert Committee on Glycated Hb. Diabetes Care, 11/84, 
7:6:602-606. Evaluation of Glycated Hb in Diabetes, Diabetes. 7/91, 
30:613-617.
    Foster, Daniel W., Diabetes Mellitus, Harrison's Principles of 
Internal Medicine. 13th ed., Kurt J. Isselbacher et al. Editors, New 
York/McGraw-Hill, 1994, pg. 1990.
    Management of Diabetes in Older Patients. Practical 
Therapeutics. 1991, Drugs 41:4:548-565.
    Koch, David D., Fructosamine: How Useful Is It?, Laboratory 
Medicine, Volume 21, No. 8, August 1990, pp. 497-503.
    Report of the Expert Committee on the Diagnosis and 
Classification of Diabetes Mellitus, Diabetes Care, Volume 20, 
Number 7, July 1997, pp. 1183 et seq.
    Sacks, David B., Carbohydrates. In Tietz Textbook of Clinical 
Chemistry, 2nd Ed., Carl A. Burtis and Edward R. Ashwood, editors. 
Philadelphia, W.B. Saunders Co., 1994. pp. 980-988.
    Tests of Glycemia in Diabetes, American Diabetes Association, 
Diabetes Care, Volume 20, Supplement I, January 1997, pp. 518-520.

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 in 
seemingly well individuals so that early detection and treatment can 
be provided for those who test positive for the disease. Screening 
tests are performed when no related 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

[[Page 13134]]

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. 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. A diagnostic statement of impaired glucose tolerance must be 
evaluated in the context of the documentation in the medical record 
in order to assign the most accurate ICD-9-CM code. An abnormally 
elevated fasting blood glucose level in the absence of the diagnosis 
of diabetes is classified to Code 790.6--other abnormal blood 
chemistry. If the provider bases the diagnostic statement of 
``impaired glucose tolerance'' on an abnormal glucose tolerance 
test, the condition is classified to 790.2--normal glucose tolerance 
test. Both conditions are considered indications for ordering 
glycated hemoglobin or glycated protein testing in the absence of 
the diagnosis of diabetes mellitus.

Medicare National Coverage Decision For Thyroid Testing

Other Names/Abbreviations

Description

    Thyroid function studies are used to delineate the presence or 
absence of hormonal abnormalities of the thyroid and pituitary 
glands. These abnormalities may be either primary or secondary and 
often but not always accompany clinically defined signs and symptoms 
indicative of thyroid dysfunction.
    Laboratory evaluation of thyroid function has become more 
scientifically defined. Tests can be done with increased 
specificity, thereby reducing the number of tests needed to diagnose 
and follow treatment of most thyroid disease. Measurements of serum 
sensitive thyroid-stimulating hormone (TSH) levels, complemented by 
determination of thyroid hormone levels [free thyroxine (fT-4) or 
total thyroxine (T4) with Triiodothyronine (T3) uptake] are used for 
diagnosis and follow-up of patients with thyroid disorders. 
Additional tests may be necessary to evaluate certain complex 
diagnostic problems or on hospitalized patients, where many 
circumstances can skew tests results. When a test for total 
thyroxine (total T4 or T4 radioimmunoassay) or T3 uptake is 
performed, calculation of the free thyroxine index (FTI) is useful 
to correct for abnormal results for either total T4 or T3 uptake due 
to protein binding effects.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
84436...............................................  Thyroxine; total.
84439...............................................  Thyroxine; free.
84443...............................................  Thyroid stimulating hormone (TSH).
84479...............................................  Thyroid hormone (T3 or T4) uptake or thyroid hormone
                                                       binding ratio (THBR).
----------------------------------------------------------------------------------------------------------------

Indications

    Thyroid function tests are used to define hyper function, 
euthyroidism, or hypofunction of thyroid disease. Thyroid testing 
may be reasonable and necessary to:
     distinguish between primary and secondary 
hypothyroidism;
     confirm or rule out primary hypothyroidism;
     monitor thyroid hormone levels (for example, patients 
with goiter, thyroid nodules, or thyroid cancer);
     monitor drug therapy in patients with primary 
hypothyroidism;
     confirm or rule out primary hyperthyroidism; and
     monitor therapy in patients with hyperthyroidism.
    Thyroid function testing may be medically necessary in patients 
with disease or neoplasm of the thyroid and other endocrine glands. 
Thyroid function testing may also be medically necessary in patients 
with metabolic disorders; malnutrition; hyperlipidemia; certain 
types of anemia; psychosis and non-psychotic personality disorders; 
unexplained depression; ophthalmologic disorders; various cardiac 
arrhythmias; disorders of menstruation; skin conditions; myalgias; 
and a wide array of signs and symptoms, including alterations in 
consciousness; malaise; hypothermia; symptoms of the nervous and 
musculoskeletal system; skin and integumentary system; nutrition and 
metabolism; cardiovascular; and gastrointestinal system.
    It may be medically necessary to do follow-up thyroid testing in 
patients with a personal history of malignant neoplasm of the 
endocrine system and in patients on long-term thyroid drug therapy.

Limitations

    Testing may be covered up to two times a year in clinically 
stable patients; more frequent testing may be reasonable and 
necessary for patients whose thyroid therapy has been altered or in 
whom symptoms or signs of hyperthyroidism or hypothyroidism are 
noted.

ICD-9-CM Codes Covered by Medicare Program.

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
017.50-017.56.......................................  Tuberculosis of the thyroid gland.
183.0...............................................  Malignant neoplasm of ovary.
193.................................................  Malignant neoplasm of thyroid gland.
194.8...............................................  Malignant neoplasm of other endocrine glands and related
                                                       structures, other.
198.89..............................................  Secondary malignant neoplasm of the thyroid.
220.................................................  Benign neoplasm of ovary.
226.................................................  Benign neoplasm of thyroid gland.
227.3...............................................  Benign neoplasm of pituitary gland and craniopharyngeal
                                                       duct.
234.8...............................................  Carcinoma in situ of other and unspecified sites.
237.4...............................................  Neoplasm of uncertain behavior of other and unspecified
                                                       endocrine glands.
239.7...............................................  Neoplasm of unspecified nature, thyroid gland.
240.0-240.9.........................................  Goiter specified and unspecified.
241.0-241.9.........................................  Nontoxic nodular goiter.
242.00-242.91.......................................  Thyrotoxicosis with or without goiter.
243.................................................  Congenital hypothyroidism.

[[Page 13135]]

 
244.0-244.9.........................................  Acquired hypothyroidism.
245.0-245.9.........................................  Thyroiditis.
246.0-246.9.........................................  Other disorders of thyroid.
250.00-250.93.......................................  Diabetes mellitus.
252.1...............................................  Hypoparathyroidism.
253.1...............................................  Other and unspecified anterior pituitary hyper function.
253.2...............................................  Panhypopituitarism.
253.3-253.4.........................................  Pituitary dwarfism.
253.4...............................................  Other anterior pituitary disorders.
253.7...............................................  Iatrogenic pituitary disorders.
255.2...............................................  Adrenogenital disorders.
255.4...............................................  Corticoadrenal insufficiency.
256.3...............................................  Ovarian failure.
257.2...............................................  Testicular hypofunction.
258.0-258.9.........................................  Polyglandular dysfunction.
262.................................................  Malnutrition, severe.
263.0-263.9.........................................  Malnutrition, other and unspecified.
266.0...............................................  Ariboflavinosis.
272.0...............................................  Pure hypercholesterolemia.
272.2...............................................  Mixed hyperlipidemia.
272.4...............................................  Other and unspecified hyperlipidemia.
275.40-275.49.......................................  Calcium disorders.
276.0...............................................  Hyposmolality andor hypernatremia.
276.1...............................................  Hyposmolality andor hyponatremia.
278.3...............................................  Hypercarotinemia.
279.4...............................................  Autoimmune disorder, not classified elsewhere.
281.0...............................................  Pernicious anemia.
281.9...............................................  Unspecified deficiency anemia.
283.0...............................................  Autoimmune hemolytic anemia.
285.9...............................................  Anemia, unspecified.
290.0...............................................  Senile dementia, uncomplicated.
290.10-290.13.......................................  Presenile dementia.
290.20-290.21.......................................  Senile dementia with delusional or depressive features.
293.0-293.1.........................................  Delirium.
293.81-293.89.......................................  Transient organic mental disorders.
294.8...............................................  Other specified organic brain syndromes.
296.00-296.99.......................................  Affective psychoses.
297.0...............................................  Paranoid state, simple.
297.9...............................................  Unspecified paranoid state.
298.3...............................................  Acute paranoid reaction.
300.00-300.09.......................................  Anxiety states.
307.9...............................................  Agitation--other and unspecified special symptoms or
                                                       syndromes, not elsewhere classified.
310.1...............................................  Organic personality syndrome.
311.................................................  Depressive disorder, not elsewhere classified.
331.0-331.2.........................................  Alzheimer's, pick's disease, Senile degeneration of brain.
333.1...............................................  Essential and other specified forms of tremor.
354.0...............................................  Carpal Tunnel syndrome.
356.9...............................................  Idiopathic peripheral neuropathy, unspecified
                                                       polyneuropathy.
359.9...............................................  Myopathy, unspecified.
368.2...............................................  Diplopia.
372.71..............................................  Conjunctival hyperemia.
372.73..............................................  Conjunctival edema.
374.41..............................................  Lid retraction or lag.
374.82..............................................  Eyelid edema.
376.30-376.31.......................................  Exophthalmic conditions, unspecified and constant.
376.33-376.34.......................................  Orbital edema or congestion, intermittent exophthalmos.
378.50-378.55.......................................  Paralytic strabismus.
401.0-401.9.........................................  Essential hypertension.
403.00-403.91.......................................  Hypertensive renal disease.
404.00-404.93.......................................  Hypertensive heart and renal disease.
423.9...............................................  Unspecified disease of pericardium.
427.0...............................................  Paroxysmal supraventricular tachycardia.
427.2...............................................  Paroxysmal tachycardia, unspecified.
427.31..............................................  Atrial fibrillation.
427.89..............................................  Other specified cardiac dysrhythmia.
427.9...............................................  Cardiac dysrhythmia, unspecified.
428.0...............................................  Congestive heart failure.
428.1...............................................  Left heart failure.
429.3...............................................  Cardiomegaly.
511.9...............................................  Unspecified pleural effusion.
518.81..............................................  Acute respiratory failure.
529.8...............................................  Other specified conditions of the tongue.
560.1...............................................  Paralytic ileus.
564.0...............................................  Constipation.

[[Page 13136]]

 
564.7...............................................  Megacolon, other than Hirschsprung's.
568.82..............................................  Peritoneal effusion (chronic).
625.3...............................................  Dysmenorrhea.
626.0-626.2.........................................  Disorders of menstruation.
626.4...............................................  Irregular menstrual cycle.
648.10-648.14.......................................  Other current conditions in the mother, classifiable
                                                       elsewhere, but complicating pregnancy, childbirth, or the
                                                       puerperium, thyroid dysfunction.
676.20-676.24.......................................  Engorgement of breast associated with childbirth and
                                                       disorders of lactation.
698.9...............................................  Unspecified pruritic disorder.
701.1...............................................  Keratoderma, acquired (dry skin).
703.8...............................................  Other specified diseases of nail (Brittle nails).
704.00-704.09.......................................  Alopecia.
709.01..............................................  Vitiligo.
710.0-710.9.........................................  Diffuse disease of connective tissue.
728.2...............................................  Muscle wasting.
728.9...............................................  Unspecified disorder of muscle, ligament, and fascia.
729.1...............................................  Myalgia and myositis, unspecified.
729.82..............................................  Musculoskeletal cramp.
730.30-.39..........................................  Periostitis without osteomyelitis.
733.09..............................................  Osteoporosis, drug induced.
750.15..............................................  Macroglossia, congenital.
759.2...............................................  Anomaly of other endocrine glands.
780.01..............................................  Coma.
780.02..............................................  Transient alteration of awareness.
780.09..............................................  Alteration of consciousness, other.
780.50-780.52.......................................  Insomnia.
780.6...............................................  Fever.
780.71-.79..........................................  Malaise and fatigue.
780.8...............................................  Hyperhidrosis.
780.9...............................................  Other general symptoms (hyperthermia).
781.0...............................................  Abnormal involuntary movements.
781.3...............................................  Lack of coordination, ataxia.
782.0...............................................  Disturbance of skin sensation.
782.3...............................................  Localized edema.
782.8...............................................  Changes in skin texture.
782.9...............................................  Other symptoms involving skin and integumentary tissues.
783.1...............................................  Abnormal weight gain.
783.2...............................................  Abnormal lost of weight.
783.6...............................................  Polyphagia.
784.1...............................................  Throat pain.
784.49..............................................  Voice disturbance.
784.5...............................................  Other speech disturbance.
785.0...............................................  Tachycardia, unspecified.
785.1...............................................  Palpitations.
785.9...............................................  Other symptoms involving cardiovascular system.
786.09..............................................  Other symptoms involving respiratory system.
786.1...............................................  Stridor.
787.2...............................................  Dysphagia.
787.91-787.99.......................................  Other symptoms involving digestive system.
789.5...............................................  Ascites.
793.9...............................................  Nonspecific abnormal findings on radiological and other
                                                       examination, other (neck).
794.5...............................................  Thyroid, abnormal scan or uptake.
796.1...............................................  Other nonspecific abnormal findings, abnormal reflex.
799.2...............................................  Nervousness.
990.................................................  Effects of radiation, unspecified.
V10.87..............................................  Personal history of malignant neoplasm of the thyroid.
V10.88..............................................  Personal history of malignant neoplasm of other endocrine
                                                       gland.
V12.2...............................................  Personal history of endocrine, metabolic and immunity
                                                       disorders.
V58.69..............................................  Long term (current) use of other medications.
V67.0-V67.9.........................................  Follow-up examination.
----------------------------------------------------------------------------------------------------------------

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 routine 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

[[Page 13137]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    AACE Clinical Practice Guidelines for the Diagnosis and 
Management of Thyroid Nodules, Endocrine Practice (1996) 2:1, pp. 
78-84.
    AACE Clinical Practice Guidelines for the Evaluation and 
Treatment of Hyperthyroidism and Hypothyroidism, Endocrine Practice 
(1995) 1:1, pp. 54-62.
    AACE Clinical Practice Guidelines for the Management of Thyroid 
Carcinoma, Endocrine Practice (1997) 3:1, pp. 60-71.
    Cooper DS. Treatment of thyrotoxicosis. In Braverman LE, Utiger 
RD, eds. Werner and Ingbar's The Thyroid: A Fundamental and Clinical 
Text. 6th ed. Philadelphia, Pa: JB Lippincott Co; 1991:887-916.
    Endocrinology. DeGroot LJ, et al. Eds. 3rd ed. Philadelphia, Pa: 
W.B.Saunders Co.; 1995.
    Endocrinology and Metabolism. Felig, P, Baxter, JD, Frohman, LA, 
eds.3rd ed. McGraw-Hill, Inc.: 1995.
    Franklyn JA. The Management of Hyperthyroidism. N Engl J Med. 
1994; 330(24):1731-1738.
    Glenn GC and the Laboratory Testing Strategy Task Force of the 
College of American Pathologists. Practice parameter on laboratory 
panel testing for screening and case finding in asymptomatic adults. 
Arch Pathol LabMed. 1996:120:929-43.
    Larsen PR, Ingbar SH. The Thyroid Gland. In: Wilson JD, Foster 
DW, eds. Williams Textbook of Endocrinology. 9th ed. Philadelphia, 
Pa: WB Saunders Co; 1992:357-487.
    The Merck Manual, 16th Edition, pp. 1072-1081.

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

[[Page 13138]]

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. When a patient is under treatment for a condition for which 
the tests in this policy are applicable, the ICD-9-CM code that best 
describes the condition is most frequently listed as the reason for 
the test.
    7. When laboratory testing is done solely to monitor response to 
medication, the most accurate ICD-9-CM code to describe the reason 
for the test would be V58.69--long term use of medication.
    8. Periodic follow-up for encounters for laboratory testing for 
a patient with a prior history of a disease, who is no longer under 
treatment for the condition, would be coded with an appropriate code 
from the V67 category--follow-up examination.
    9. According to ICD-9-CM coding conventions, codes that appear 
in italics in the Alphabetic and/or Tabular columns of ICD-9-CM are 
considered manifestation codes that require the underlying condition 
to be coded and sequenced ahead of the manifestation. For example, 
the diagnostic statement ``thyrotoxic exophthalmos (376.21),'' which 
appears in italics in the tabular listing, requires that the thyroid 
disorder (242.0-242.9) is coded and sequenced ahead of thyrotoxic 
exophthalmos. Therefore, a diagnostic statement that is listed as a 
manifestation in ICD-9-CM must be expanded to include the underlying 
disease in order to accurately code the condition.
    10. Use code 728.9 to report muscle weakness as the indication 
for the test. Other diagnoses included in 728.9 do not support 
medical necessity.
    11. Use code 194.8 (Malignant neoplasm of other endocrine glands 
and related structures, Other) to report multiple endocrine 
neoplasia syndromes (MEN-1 and MEN-2). Other diagnoses included in 
194.8 do not support medical necessity.

Documentation Requirements

    When these tests are billed at a greater frequency than the norm 
(two per year), the ordering physician's documentation must support 
the medical necessity of this frequency.

Medicare National Coverage Decision for Lipids

Other Names/Abbreviations

Description

    Lipoproteins are a class of heterogeneous particles of varying 
sizes and densities containing lipid and protein. These lipoproteins 
include cholesterol esters and free cholesterol, triglycerides, 
phospholipids and A, C, and E apoproteins. Total cholesterol 
comprises all the cholesterol found in various lipoproteins.
    Factors that affect blood cholesterol levels include age, sex, 
body weight, diet, alcohol and tobacco use, exercise, genetic 
factors, family history, medications, menopausal status, the use of 
hormone replacement therapy, and chronic disorders such as 
hypothyroidism, obstructive liver disease, pancreatic disease 
(including diabetes), and kidney disease.
    In many individuals, an elevated blood cholesterol level 
constitutes an increased risk of developing coronary artery disease. 
Blood levels of total cholesterol and various fractions of 
cholesterol, especially low density lipoprotein cholesterol (LDL-C) 
and high density lipoprotein cholesterol (HDL-C), are useful in 
assessing and monitoring treatment for that risk in patients with 
cardiovascular and related diseases. Blood levels of the above 
cholesterol components including triglyceride have been separated 
into desirable, borderline and high risk categories by the National 
Heart, Lung and Blood Institute in their report in 1993. These 
categories form a useful basis for evaluation and treatment of 
patients with hyperlipidemia (See Reference). Therapy to reduce 
these risk parameters includes diet, exercise and medication, and 
fat weight loss, which is particularly powerful when combined with 
diet or exercise.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
80061...............................................  Lipid panel.
82465...............................................  Cholesterol, serum, total.
83715...............................................  Lipoprotein, blood; electrophoretic separation and
                                                       quantitation.
83716...............................................  Lipoprotein, blood: high resolution fractionation and
                                                       quantitation of lipoprotein cholesterols (for example,
                                                       electrophoretic, nuclear magnetic resonance,
                                                       ultracentrifugation).
83718...............................................  Lipoprotein, direct measurement; high density cholesterol
                                                       (HDL cholesterol).
83721...............................................  Lipoprotein, direct measurement, LDL cholesterol.
84478...............................................  Triglycerides.
----------------------------------------------------------------------------------------------------------------

Indications

    The medical community recognizes lipid testing as appropriate 
for evaluating atherosclerotic cardiovascular disease. Conditions in 
which lipid testing may be indicated include:
     assessment of patients with atherosclerotic 
cardiovascular disease;
     evaluation of primary dyslipidemias;
     any form of atherosclerotic disease;
     diagnostic evaluation of diseases associated with 
altered lipid metabolism, such as: nephrotic syndrome, pancreatitis, 
hepatic disease, and hypo and hyperthyroidism;
     secondary dyslipidemias, including diabetes mellitus, 
disorders of gastrointestinal absorption, chronic renal failure; and
     signs or symptoms of dyslipidemias, such as skin 
lesions.
     as follow-up to the initial screen for coronary heart 
disease (total cholesterol + HDL cholesterol) when total cholesterol 
is determined to be high (>240 mg/dL), or borderline-high (200-240 
mg/dL) plus two or more coronary heart disease risk factors, or an 
HDL cholesterol 35 mg/dl.
    To monitor the progress of patients on anti-lipid dietary 
management and pharmacologic therapy for the treatment of elevated 
blood lipid disorders, total cholesterol, HDL cholesterol and LDL 
cholesterol may be used. Triglycerides may be obtained if this lipid 
fraction is also elevated or if the patient is put on drugs (for 
example, thiazide diuretics, beta blockers, estrogens, 
glucocorticoids, and tamoxifen) which may raise the triglyceride 
level.
    When monitoring long term anti-lipid dietary or pharmacologic 
therapy and when following patients with borderline high total or 
LDL cholesterol levels, it may be reasonable to perform the lipid 
panel annually. A lipid panel (CPT code 80061) at a yearly interval 
will usually be adequate while measurement of the serum total

[[Page 13139]]

cholesterol (CPT code 82465) or a measured LDL (CPT code 83721) 
should suffice for interim visits if the patient does not have 
hypertriglyceridemia (for example, ICD-9-CM code 272.1, Pure 
hyperglyceridemia).
    Any one component of the panel or a measured LDL may be 
reasonable and necessary up to six times the first year for 
monitoring dietary or pharmacologic therapy. More frequent total 
cholesterol HDL cholesterol, LDL cholesterol and triglyceride 
testing may be indicated for marked elevations or for changes to 
anti-lipid therapy due to inadequate initial patient response to 
dietary or pharmacologic therapy. The LDL cholesterol or total 
cholesterol may be measured three times yearly after treatment goals 
have been achieved.
    Electrophoretic or other quantitation of lipoproteins (CPT codes 
83715 and 83716) may be indicated if the patient has a primary 
disorder of lipoid metabolism (ICD-9-CM codes 272.0 to 272.9).

Limitations

    Lipid panel and hepatic panel testing may be used for patients 
with severe psoriasis which has not responded to conventional 
therapy and for which the retinoid estretinate has been prescribed 
and who have developed hyperlipidemia or hepatic toxicity. Specific 
examples include erythrodermia and generalized pustular type and 
psoriasis associated with arthritis.
    Routine screening and prophylactic testing for lipid disorder 
are not covered by Medicare. While lipid screening may be medically 
appropriate, Medicare by statute does not pay for it. Lipid testing 
in asymptomatic individuals is considered to be screening regardless 
of the presence of other risk factors such as family history, 
tobacco use, etc.
    Once a diagnosis is established, one or several specific tests 
are usually adequate for monitoring the course of the disease. Less 
specific diagnoses (for example, other chest pain) alone do not 
support medical necessity of these tests.
    When monitoring long term anti-lipid dietary or pharmacologic 
therapy and when following patients with borderline high total or 
LDL cholesterol levels, it is reasonable to perform the lipid panel 
annually. A lipid panel (CPT code 80061) at a yearly interval will 
usually be adequate while measurement of the serum total cholesterol 
(CPT code 82465) or a measured LDL (CPT code 83721) should suffice 
for interim visits if the patient does not have hypertriglyceridemia 
(for example, ICD-9-CM code 272.1, Pure hyperglyceridemia).
    Any one component of the panel or a measured LDL may be 
medically necessary up to six times the first year for monitoring 
dietary or pharmacologic therapy. More frequent total cholesterol 
HDL cholesterol, LDL cholesterol and triglyceride testing may be 
indicated for marked elevations or for changes to anti-lipid therapy 
due to inadequate initial patient response to dietary or 
pharmacologic therapy. The LDL cholesterol or total cholesterol may 
be measured three times yearly after treatment goals have been 
achieved.
    If no dietary or pharmacological therapy is advised, monitoring 
is not necessary.
    When evaluating non-specific chronic abnormalities of the liver 
(for example, elevations of transaminase, alkaline phosphatase, 
abnormal imaging studies, etc.), a lipid panel would generally not 
be indicated more than twice per year.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
242.00-245.9........................................  Disorders of the thyroid gland with hormonal dysfunction.
250.00-.93..........................................  Diabetes mellitus.
255.0...............................................  Cushing's syndrome.
260.................................................  Kwashiorkor.
261.................................................  Nutritional marasmus.
262.................................................  Other severe, protein-calorie malnutrition.
263.0...............................................  Malnutrition of moderate degree.
263.1...............................................  Malnutrition of mild degree.
263.8...............................................  Other protein-calorie malnutrition.
263.9...............................................  Unspecified protein-calorie malnutrition.
270.0...............................................  Disturbances of amino-acid transport.
271.1...............................................  Galactosemia.
272.0...............................................  Pure hypercholesterolemia.
272.1...............................................  Hyperglyceridemia.
272.2...............................................  Mixed hyperlipidemia (tuberous xanthoma).
272.3...............................................  Hyperchylomicronemia.
272.4...............................................  Other and unspecified hyperlipidemia (unspecified
                                                       xanthoma).
272.5...............................................  Lipoprotein deficiencies.
272.6...............................................  Lipodystrophy.
272.7...............................................  Lipidoses.
272.8...............................................  Other disorders of lipoid metabolism.
272.9...............................................  Unspecified disorders of lipoid metabolism.
277.3...............................................  Amyloidosis.
278.01..............................................  Morbid obesity.
303.90-303.92.......................................  Alcoholism.
362.10-362.16.......................................  Other background retinopathy and retinal vascular change.
362.30-362.34.......................................  Retinal vascular occlusion.
362.82..............................................  Retinal exudates and deposits.
371.41..............................................  Corneal arcus, juvenile.
374.51..............................................  Xanthelasma.
379.22..............................................  Crystalline deposits in vitreous.
388.00..............................................  Degenerative & vascular disorder of ear, unspecified.
388.02..............................................  Transient ischemic deafness.
410.00-410.92.......................................  Acute myocardial infarction.
411.0-411.1.........................................  Other acute & subacute forms of ischemic heart disease.
411.81..............................................  Coronary occlusion without myocardial infarction.
411.89..............................................  Other acute and subacute ischemic heart disease.
412.................................................  Old myocardial infarction.
413.0-413.1.........................................  Angina pectoris.
413.9...............................................  Other and unspecified angina pectoris.
414.00-414.03.......................................  Coronary atherosclerosis.
414.04..............................................  Coronary athrscl-artery bypass graft.
414.05..............................................  Coronary athrscl-unspec graft.
414.10..............................................  Aneurysm, heart (wall).
414.11..............................................  Coronary vessel aneurysm.

[[Page 13140]]

 
414.19..............................................  Other aneurysm of heart.
414.8...............................................  Other specified forms of chronic ischemic heart disease.
414.9...............................................  Chronic ischemic heart disease, unspecified.
428.0-428.9.........................................  Heart failure.
429.2...............................................  Arteriosclerotic cardiovascular disease.
429.9...............................................  Heart disease NOS.
431.................................................  Intracerebral hemorrhage.
433.00-.91..........................................  Occlusion & stenosis of precerebral arteries.
434.00-.91..........................................  Occlusion of cerebral arteries.
435.0-.9............................................  Transient cerebral ischemia.
437.0...............................................  Other & ill-defined cerebrovascular disease.
437.1...............................................  Other generalized ischemic cerebrovascular disease.
437.5...............................................  Moyamoya disease.
438.0-.9............................................  Late effects of cerebrovascular disease.
440.0-440.9.........................................  Arteriosclerosis.
441.00-441.9........................................  Aortic aneurysms.
442.0...............................................  Upper extremity aneurysm.
442.1...............................................  Renal artery aneurysm.
442.2...............................................  Iliac artery aneurysm.
444.0-.9............................................  Arterial embolism & thrombosis.
557.1...............................................  Chronic vascular insufficiency of intestine.
571.8...............................................  Other chronic non-alcoholic liver disease.
571.9...............................................  Unspecified chronic liver disease without mention of
                                                       alcohol.
573.8...............................................  Other specified disorders of liver.
573.9...............................................  Unspecified disorders of liver.
577.0-577.9.........................................  Pancreatic disease.
579.3...............................................  Other & unspecified postsurgical nonabsorption.
579.8...............................................  Other specified intestinal malabsorption.
581.0-581.9.........................................  Nephrotic syndrome.
584.5...............................................  Acute renal failure with lesion of tubular necrosis.
585.................................................  Chronic renal failure.
588.0...............................................  Renal osteodystrophy.
588.1...............................................  Nephrogenic diabetes insipidus.
588.8...............................................  Other specified disorders resulting from impaired renal
                                                       function.
588.9...............................................  Unspecified disorder resulting from impaired renal
                                                       function.
607.84..............................................  Impotence of organic origin, penis disorder.
646.70-646.71.......................................  Liver disorders in pregnancy.
646.73..............................................  Liver disorder antepartum.
648.10-648.14.......................................  Thyroid disfunction in pregnancy and the puerperium.
6.0.................................................  Psoriatic arthropathy.
696.1...............................................  Other psoriasis.
751.61..............................................  Biliary atresia.
764.10-764.19.......................................  ``Light for dates'' with signs of fetal malnutrition.
786.50..............................................  Chest pain unspecified.
786.51..............................................  Precordial pain.
786.59..............................................  Chest pain, other.
789.1...............................................  Hepatomegaly.
790.4...............................................  Abnormal transaminase.
790.5...............................................  Abnormal alkaline phosphatase.
790.6...............................................  Other abnormal blood chemistry.
793.4...............................................  Abnormal imaging study.
987.9...............................................  Toxic effect of unspecified gas or vapor.
996.81..............................................  Complication of transplanted organ, kidney, failure.
V42.0...............................................  Transplanted organ, kidney.
V58.69..............................................  Long term (current) use of other medications.
----------------------------------------------------------------------------------------------------------------

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

[[Page 13141]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    American Diabetes Association. Management of Dyslipidemia in 
Adults with Diabetes. J. Florida M.A. 1998, 85:2 30-34.
    Jialal, I. Evolving lipoprotein risk factors: lipoprotein (a) 
and oxidizing low-density lipoprotein. Clin Chem 1998; 44:8(B) 1827-
1832.
    McMorrow, ME, Malarkey, L. Laboratory and Diagnostic Tests: A 
Pocket Guide. W.B. Saunders Company. 206-207.
    U.S. Department of Health and Human Services. National 
Cholesterol Education Program. Recommendations for Improving 
Cholesterol Measurement. NIH Publication 90-2964. February 1990.
    National Institutes of Health. Second Report of the Expert Panel 
on Detection, Evaluation, and Treatment of High Blood Cholesterol in 
Adults. NIH Publication 93-3095. September 1993.
    Bierman EL. Atherosclerosis and other forms of arteriosclerosis. 
Harrison's Principles of Internal Medicine. Eds. Isselbacher KJ, 
Braunwald E, Wilson JD, et al. McGraw-Hill. New York. 1994; 2058-
2069.
    Brown MS and Goldstein JL. The hyperlipoproteinemias and other 
disorders of lipid metabolism. Harrison's Principles of Internal 
Medicine. Eds. Isselbacher KJ, Braunwald E, Wilson JD, et al. 
McGraw-Hill. New York. 1994; 1106-1116.

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.)

[[Page 13142]]

    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 nonspecific 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 Digoxin Therapeutic Drug 
Assay

Other Names/Abbreviations

Description

    A digoxin therapeutic drug assay is useful for diagnosis and 
prevention of digoxin toxicity, and/or prevention for under dosage 
of digoxin.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
80162...............................................  Digoxin (Therapeutic Drug Assay)
----------------------------------------------------------------------------------------------------------------

Indications

    Digoxin levels may be performed to monitor drug levels of 
individuals receiving digoxin therapy because the margin of safety 
between side effects and toxicity is narrow or because the blood 
level may not be high enough to achieve the desired clinical effect.
    Clinical indications may include individuals on digoxin:
     With symptoms, signs or electrocardiogram (ECG) 
suggestive of digoxin toxicity;
     Taking medications that influence absorption, 
bioavailability, distribution, and/or elimination of digoxin;
     With impaired renal, hepatic, gastrointestinal, or 
thyroid function;
     With pH and/or electrolyte abnormalities;
     With unstable cardiovascular status, including 
myocarditis;
     Requiring monitoring of patient compliance.
    Clinical indications may include individuals:
     Suspected of accidental or intended overdose; or
     Who have an acceptable cardiac diagnosis (as listed) 
and for whom an accurate history of use of digoxin is unobtainable
    The value of obtaining regular serum digoxin levels is 
uncertain, but it may be reasonable to check levels once yearly 
after a steady state is achieved. In addition, it may be reasonable 
to check the level if:
     Heart failure status worsens;
     Renal function deteriorates;
     Additional medications are added that could affect the 
digoxin level; or
     Signs or symptoms of toxicity develop.
    Steady state will be reached in approximately 1 week in patients 
with normal renal function, although 2-3 weeks may be needed in 
patients with renal impairment. After changes in dosages or the 
addition of a medication that could affect the digoxin level, it is 
reasonable to check the digoxin level one week after the change or 
addition. Based on the clinical situation, in cases of digoxin 
toxicity, testing may need to be done more than once a week.
    Digoxin is indicated for the treatment of patients with heart 
failure due to systolic dysfunction and for reduction of the 
ventricular response in patients with atrial fibrillation or 
flutter. Digoxin may also be indicated for the treatment of other 
supraventricular arrhythmias, particularly in the presence of heart 
failure.

Limitations

    This test is not appropriate for patients on digitoxin or 
treated with digoxin FAB (fragment antigen binding) antibody.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
242.00-242.91.......................................  Thyrotoxicosis with or without goiter.
243.................................................  Congenital hypothyroidism.
244.0-244.9.........................................  Acquired hypothyroidism.
245.0-245.9.........................................  Thyroiditis.
275.2...............................................  Disorders of magnesium metabolism.
275.40-.49..........................................  Disorders of calcium metabolism.
276.0...............................................  Hyperosmolality.
276.1...............................................  Hyposmolality.
276.2...............................................  Acidosis.
276.3...............................................  Alkalosis.
276.4...............................................  Mixed acid-base balance disorder.
276.5...............................................  Volume depletion.
276.6...............................................  Fluid overload.
276.7...............................................  Hyperpotassemia.
276.8...............................................  Hypopotassemia.
276.9...............................................  Electrolyte and fluid disorder (not elsewhere classified).
293.0...............................................  Acute delirium.
293.1...............................................  Subacute delirium.
307.47..............................................  Other dysfunctions of sleep stages or arousal from sleep.
368.16..............................................  Psychophysical visual disturbances.
368.8...............................................  Other specified visual disturbances.
368.9...............................................  Unspecified visual disturbances.
397.9...............................................  Rheumatic diseases of endocardium.
398.0...............................................  Rheumatic myocarditis.
398.91..............................................  Rheumatic heart Failure.
402.01..............................................  Hypertensive heart disease, malignant with CHF.
402.11..............................................  Hypertensive heart disease, benign with CHF.
402.91..............................................  Hypertensive heart disease, unspecified with CHF.
403.00-403.91.......................................  Hypertensive renal disease.
404.00-404.93.......................................  Hypertensive heart & renal disease.
410.00-410.92.......................................  Acute myocardial infarction.
411.0-411.89........................................  Other acute & subacute forms of ischemic heart disease.
413.0-413.9.........................................  Angina pectoris.

[[Page 13143]]

 
422.0-422.99........................................  Acute myocarditis.
425.0-425.9.........................................  Cardiomyopathy.
426.0-426.9.........................................  Conduction disorders.
427.0-427.9.........................................  Cardiac dysrhythmias.
428.0-428.9.........................................  Heart failure.
429.4...............................................  Heart disturbances postcardiac surgery.
429.5...............................................  Rupture chordae tendinae.
429.6...............................................  Rupture papillary muscle.
429.71..............................................  Acquired cardiac septal defect.
514.................................................  Pulmonary congestion & hypostasis.
579.9...............................................  Unspecified intestinal malabsorption.
584.5-584.9.........................................  Acute renal failure.
585.................................................  Chronic renal failure.
586.................................................  Renal failure, unspecified.
587.................................................  Renal sclerosis, unspecified.
588.0...............................................  Renal osteodystrophy.
588.1...............................................  Nephrogenic Diabetes Insipidus.
588.8...............................................  Impaired renal function (not elsewhere classified).
588.9...............................................  Unspecified disorder resulting from impaired renal
                                                       function.
780.01..............................................  Coma.
780.02..............................................  Transient alteration of awareness.
780.09..............................................  Other ill-defined general symptoms (drowsiness, semicoma,
                                                       somnolence, stupor, unconsciousness).
780.1...............................................  Hallucinations.
780.2...............................................  Syncope & collapse.
780.4...............................................  Dizziness and giddiness.
780.71-.79..........................................  Malaise & fatigue.
783.0...............................................  Anorexia.
784.0...............................................  Headache.
787.01-787.03.......................................  Nausea & vomiting.
787.91..............................................  Diarrhea.
794.31..............................................  Abnormal electrocardiogram.
799.2...............................................  Nervousness.
972.1...............................................  Poisoning by cardiotonic glycosides & drugs of similar
                                                       action.
995.2...............................................  Unspecified adverse effect of drug, medicinal and
                                                       biological substance.
*E942.1.............................................  Adverse effect of cardiotonic glycosides and drugs of
                                                       similar action.
V58.69..............................................  Encounter long term--medication use (not elsewhere
                                                       classified).
----------------------------------------------------------------------------------------------------------------
*Code may not be reported as a stand-alone or first-listed code on the claim.

Reasons For Denial

    Note: 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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.

[[Page 13144]]

 
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

Code:      Description

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

Sources of Information

    Doherty JE. Digitalis serum levels: clinical use. Ann Intern Med 
1971 May; 74(5):787-789.
    Duhme DW, Greenblatt DJ, Koch-Weser J. Reduction of digoxin 
toxicity associated with measurement of serum levels. A report from 
the Boston Collaborative Drug Surveillance Program. Ann Intern Med 
1974 Apr; 80(4):516-519.
    Goldman RH. The use of serum digoxin levels in clinical 
practice. JAMA 1974, Jul 15; 229(3):331-332.
    Howanitz PJ, Steindel SJ. Digoxin therapeutic drug monitoring 
practices. A College of American Pathologists Q-Probes study of 666 
institutions and 18,679 toxic levels. Arch Pathol Lab Med 1993 Jul; 
117(7):684-690.
    Marcus FI. Pharmacokinetic interactions between digoxin and 
other drugs. J Am Coll Cardiol 1985 May; 5(5 Suppl A):82A-90A.
    Rodin SM, Johnson BF. Pharmacokinetic interactions with digoxin. 
Clin Pharmaco-kinet 1988 Oct; 15(4):227-244.
    Smith TW, Butler VP Jr, Haber E. Determination of therapeutic 
and toxic serum digoxin concentrations by radioimmunoassay. N Engl J 
Med 1969 Nov 27; 281(22):1212-1216.
    Smith TW, Haber E. Digoxin intoxication: the relationship of 
clinical presentation to serum digoxin concentration. J Clin Invest 
1970, Dec; 49 (12):2377-2386.
    Valdes R Jr, Jortani SA, Gheorghiade M. Standards of laboratory 
practice: cardiac drug monitoring. National Academy of Clinical 
Biochemistry. Clin Chem 1998 May; 44(5): 1096-1109.
    Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation 
and Care of Patients with Left-Ventricular Systolic Dysfunction. 
Clinical Practice Guideline No. 11. AHCPR Publication No. 94-0612. 
Rockville, MD: Agency for Health Care Policy and Research, Public 
Health Service, U.S. Department of Health and Human Services. June 
1994.

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 Alpha-fetoprotein

    Other Names/Abbreviations: Afp.

Description

    Alpha-fetoprotein (AFP) is a polysaccharide found in some 
carcinomas. It is effective as a biochemical marker for monitoring 
the response of certain malignancies to therapy.

HCPCS Codes (Alpha numeric, CPT  AMA):

[[Page 13145]]



----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82105...............................................  Alpha-fetoprotein; serum.
----------------------------------------------------------------------------------------------------------------

Indications

    AFP is useful for the diagnosis of hepatocellular carcinoma in 
high-risk patients (such as alcoholic cirrhosis, cirrhosis of viral 
etiology, hemochromatosis, and alpha 1-antitrypsin 
deficiency) and in separating patients with benign hepatocellular 
neoplasms or metastases from those with hepatocellular carcinoma 
and, as a non-specific tumor associated antigen, serves in marking 
germ cell neoplasms of the testis, ovary, retro peritoneum, and 
mediastinum.

Limitations

ICD-9-09CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
070.22-070.23.......................................  Chronic viral hepatitis B with hepatic coma, with or
                                                       without mention of hepatitis delta
070.32-070.33.......................................  Chronic viral hepatitis B without mention of hepatic coma,
                                                       with or without mention of hepatitis delta
070.44..............................................  Chronic hepatitis C with hepatic coma
070.54..............................................  Chronic hepatitis C without mention of hepatic coma
095.3...............................................  Syphilis of liver
121.1...............................................  Clonorchiasis
121.3...............................................  Fascioliasis
155.0-155.2.........................................  Malignant neoplasm of the liver and intrahepatic bile
                                                       ducts
164.2-164.9.........................................  Malignant neoplasm of the mediastinum
183.0...............................................  Malignant neoplasm, ovary
186.0...............................................  Malignant neoplasm of undescended testis
186.9...............................................  Malignant neoplasm, other and unspecific testis
197.1...............................................  Secondary malignant neoplasm of mediastinum
197.7...............................................  Secondary malignant neoplasm of liver
198.6...............................................  Secondary malignant neoplasm of ovary
198.82..............................................  Secondary malignant neoplasm, genital organs
211.5...............................................  Benign neoplasm of liver and biliary passages
235.3...............................................  Neoplasm of uncertain behavior of liver and biliary
                                                       passages
272.2...............................................  Mixed hyperlipidemia
275.0...............................................  Disorder of iron metabolites
275.1...............................................  Disorder of copper metabolism
277.00..............................................  Cystic Fibrosis without mention of meconium ileus
277.6...............................................  Other deficiencies of circulating enzymes
285.0...............................................  Sideroblastic Anemia
571.2...............................................  Alcoholic cirrhosis of liver
571.40..............................................  Chronic hepatitis, unspecified
571.41..............................................  Chronic persistent hepatitis
571.49..............................................  Other chronic hepatitis
571.5...............................................  Cirrhosis of liver without mention of alcohol
608.89..............................................  Other specified disorders of male genital organs
793.1...............................................  Non-specific abnormal findings of lung field
793.2...............................................  Non-specific abnormal findings of other intrathoracic
                                                       organs
793.3...............................................  Non-specific abnormal findings of biliary tract
793.6...............................................  Non-specific abnormal findings of abdominal area,
                                                       including retro peritoneum
V10.07..............................................  Personal history of malignant neoplasm, liver
V10.43..............................................  Personal history of malignant neoplasm, ovary
V10.47..............................................  Personal history of malignant neoplasm, testis
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE

[[Page 13146]]

devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995).

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.
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-099-09CM Codes That Do Not Support Medical Necessity

Code:    Description

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

Sources of Information

    Tatsuta M. Yamamura H. Iishi H. Kasugai H. Okuda S.Value of 
serum alpha-fetoprotein and ferritin in the diagnosis of 
hepatocellular carcinoma. Oncology. 43(5):306-10, 1986.

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 described by that code must be related 
to the above indications for the test.

Medicare National Coverage Decision for Carcinoembryonic Antigen

    Other Names/Abbreviations: CEA.

Description

    Carcinoembryonic antigen (CEA) is a protein polysaccharide found 
in some carcinomas. It is effective as a biochemical marker for 
monitoring the response of certain malignancies to therapy.

HCPCS Codes (Alpha numeric, CPT  AMA):

[[Page 13147]]



----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82378...............................................  Carcinoembryonic antigen (CEA).
----------------------------------------------------------------------------------------------------------------

Indications

    CEA may be medically necessary for follow-up of patients with 
colorectal carcinoma. It would however only be medically necessary 
at treatment decision-making points. In some clinical situations 
(e.g. adenocarcinoma of the lung, small cell carcinoma of the lung, 
and some gastrointestinal carcinomas) when a more specific marker is 
not expressed by the tumor, CEA may be a medically necessary 
alternative marker for monitoring. Preoperative CEA may also be 
helpful in determining the post-operative adequacy of surgical 
resection and subsequent medical management. In general, a single 
tumor marker will suffice in following patients with colorectal 
carcinoma or other malignancies that express such tumor markers.
    In following patients who have had treatment for colorectal 
carcinoma, ASCO guideline suggests that if resection of liver 
metastasis would be indicated, it is recommended that post-operative 
CEA testing be performed every two to three months in patients with 
initial stage II or stage III disease for at least two years after 
diagnosis.
    For patients with metastatic solid tumors which express CEA, CEA 
may be measured at the start of the treatment and with subsequent 
treatment cycles to assess the tumor's response to therapy.

Limitations

    Serum CEA determinations are generally not indicated more 
frequently than once per chemotherapy treatment cycle for patients 
with metastatic solid tumors which express CEA or every two months 
post-surgical treatment for patients who have had colorectal 
carcinoma. However, it may be proper to order the test more 
frequently in certain situations, for example, when there has been a 
significant change from prior CEA level or a significant change in 
patient status which could reflect disease progression or 
recurrence.
    Testing with a diagnosis of an in situ carcinoma is not 
reasonably done more frequently than once, unless the result is 
abnormal, in which case the test may be repeated once.

ICD-9-09-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
150.0-150.9.........................................  Malignant neoplasm of the esophagus.
151.0-151.9.........................................  Malignant neoplasm of stomach.
152.0-154.8.........................................  Malignant neoplasm of small intestine, including duodenum,
                                                       rectum, rectosigmoid junction and anus.
157.0-157.9.........................................  Primary malignancy of pancreas.
159.0...............................................  Malignant neoplasm of intestinal tract, part unspecified.
162.0-162.9.........................................  Malignant neoplasm of trachea, bronchus, lung.
174.0-174.9.........................................  Malignant neoplasm of female breast.
175.0-175.9.........................................  Malignant neoplasm of male breast.
183.0...............................................  Malignant neoplasm of ovary.
197.0...............................................  Secondary malignant neoplasm of neoplasm of lung.
197.4...............................................  Secondary malignant neoplasm of small intestine.
197.5...............................................  Secondary malignant neoplasm of large intestine and
                                                       rectum.
230.3...............................................  Carcinoma in situ of colon.
230.4...............................................  Carcinoma in situ of rectum.
230.7...............................................  Carcinoma in situ of other/unspecified parts of intestine.
230.9...............................................  Carcinoma in situ other and unspecified digestive organs.
235.2...............................................  Neoplasm of uncertain behavior of stomach, intestines,
                                                       rectum.
790.99..............................................  Other nonspecific findings on examination of blood.
V10.00..............................................  Personal history of malignant neoplasm of gastro-
                                                       intestinal tract, unspecified.
V10.3...............................................  Personal history of malignant neoplasm, breast.
V10.05..............................................  Personal history of malignant neoplasm, large intestine.
V10.06..............................................  Personal history of malignant neoplasm, rectum,
                                                       rectosigmoid junction, anus.
V10.11..............................................  Personal history of malignant neoplasm, bronchus, and
                                                       lung.
V10.43..............................................  Personal history of malignant neoplasm, ovary.
V67.2...............................................  Follow-up examination following chemotherapy.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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

[[Page 13148]]

Exemption (IDE). Coverage of Category B IDE devices is left to 
contractor discretion. (See 60 FR 48425, Sept. 19, 1995).

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9 S.......................................  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

Code:      Description

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

Sources of Information

    Journal Clinical Oncol: 14(10:2843-2877), 1996
    Vauthey JN. Dudrick PS. Lind DS. Copeland EM 3rd. Management of 
recurrent colorectal cancer: another look at carcinoembryonic 
antigen-detected recurrence [see comments]. [Review] Digestive 
Diseases. 14(1):5-13, 1996 Jan-Feb.
    Grem J. The prognostic importance of tumor markers in 
adenocarcinomas of the gastrointestinal tract. [Review] [38 refs] 
Current Opinion in Oncology. 9(4):380-7, 1997 Jul.
    Bergamaschi R. Arnaud JP. Routine compared with nonscheduled 
follow-up of patients with ``curative'' surgery for colorectal 
cancer. Annals of Surgical Oncology. 3(5):464-9, 1996 Sep.
    Kim YH. Ajani JA. Ota DM. Lynch P. Roth JA. Value of serial 
carcinoembryonic antigen levels in patients with resectable 
adenocarcinoma of the esophagus and stomach Cancer. 75(2):451-6, 
1995 Jan 15.

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 nonspecific ICD-9-CM code is submitted, the underlying 
sign, symptom, or condition must be related to the indications for 
the test above.
    6. To show elevated CEA, use ICD-9-CM 790.99 (Other nonspecific 
findings on examination of blood) only if a more specific diagnosis 
has not been made. If a more specific diagnosis has been made, use 
the code for that diagnosis.

[[Page 13149]]

Medicare National Coverage Decision for Human Chorionic 
Gonadotropin

    Other Names/Abbreviations: hCG.

Description

    Human chorionic gonadotropin

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
84702...............................................  Gonodotropin, chorionic (hCG); quantitative.
----------------------------------------------------------------------------------------------------------------

Indications

    hCG is useful for monitoring and diagnosis of germ cell 
neoplasms of the ovary, testis, mediastinum, retroperitoneum, and 
central nervous system. In addition, it is useful for diagnosis of 
pregnancy and pregnancy-associated conditions.

Limitations

    Not more than once per month for diagnostic purposes. As needed 
for monitoring of patient progress and treatment. Qualitative hCG 
assays (CPT 84703) are not appropriate for medically managing 
patients with known or suspected germ cell neoplasms.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
158.0...............................................  Malignant neoplasm of retroperitoneum.
158.8...............................................  Malignant neoplasm of specified parts of peritoneum.
164.2...............................................  Malignant neoplasm of anterior mediastinum.
164.3...............................................  Malignant neoplasm of posterior mediastinum.
164.8...............................................  Malignant neoplasm, other (includes malignant neoplasm of
                                                       contiguous overlapping sites of thymus, heart, and
                                                       mediastinum whose point of origin cannot be determined.
164.9...............................................  Malignant neoplasm of mediastinum, part unspecified.
181.................................................  Malignant neoplasm of placenta.
183.0...............................................  Malignant neoplasm of ovary.
183.8...............................................  Other specified sites of uterine adnexas.
186.0...............................................  Malignant neoplasm of undescended testes.
186.9...............................................  Malignant neoplasm of other and unspecified testis.
194.4...............................................  Malignant neoplasm of pineal gland.
197.1...............................................  Secondary malignant neoplasm of mediastinum.
197.6...............................................  Secondary malignant neoplasm of retroperitoneum and
                                                       peritoneum.
198.6...............................................  Secondary malignant neoplasm of ovary.
198.82..............................................  Secondary malignant neoplasm of other genital organs.
236.1...............................................  Neoplasm of uncertain behavior, placenta.
623.8...............................................  Vaginal bleeding.
625.9...............................................  Pelvic pain.
630.................................................  Hydatidiform mole.
631.................................................  Pregnancy, molar.
632.................................................  Missed abortion.
633.9...............................................  Ectopic pregnancy.
640.00-.............................................  Threatened abortion.
V10.09..............................................  Personal history of malignant neoplasm, other
                                                       gastrointestinal sites.
V10.29..............................................  Personal history of malignant neoplasm of other
                                                       respiratory and intrathoracic organs.
V10.43..............................................  Personal history of malignant neoplasm, ovary.
V10.47..............................................  Personal history of malignant neoplasm, testis.
V22.0-.1............................................  Pregnancy.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

ICD-9-CM Codes Denied:

[[Page 13150]]



----------------------------------------------------------------------------------------------------------------
                        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.
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

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

Sources of Information

    O'Callaghan A. Mead GM. Testicular carcinoma. [Review] [23 Refs] 
Postgraduate Medical Journal. 73(862):4816, 1997 Aug.
    Sawamura Y. Current diagnosis and treatment of central nervous 
system germ cell tumours. [Review] [47 Refs] Current Opinion in 
Neurology. 9(6):41923, 1996 Dec.
    Wilkins M. Horwich A. Diagnosis and treatment of urological 
malignancy: The testes. [Review] [23 Refs] British Journal of 
Hospital Medicine. 55(4): 199203, 1996. Feb 21, Mar 5.

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 nonspecific 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 Tumor Antigen by 
Immunoassay--CA125

Other Names/Abbreviations

Description

    Immunoassay determinations of the serum levels of certain 
proteins or carbohydrates serve as tumor markers. When elevated, 
serum concentration of these markers may reflect tumor size and 
grade.
    This policy specifically addresses tumor antigen CA125.

HCPCS Codes (Alpha numeric, CPT  AMA):

[[Page 13151]]



----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
Not yet assigned....................................  Tumor antigen 125.
----------------------------------------------------------------------------------------------------------------

Indications

    CA125 is a high molecular weight serum tumor marker elevated in 
80% of patients who present with epithelial ovarian carcinoma. It is 
also elevated in carcinomas of the fallopian tube, endometrium, and 
endocervix. An elevated level may also be associated with the 
presence of a malignant mesothelioma.
    A CA125 level may be obtained as part of the initial pre-
operative work-up for women presenting with a suspicious pelvic mass 
to be used as a baseline for purposes of post-operative monitoring. 
Initial declines in CA125 after initial surgery and/or chemotherapy 
for ovarian carcinoma are also measured by obtaining three serum 
levels during the first month post treatment to determine the 
patient's CA125 half-life, which has significant prognostic 
implications.
    CA125 levels are again obtained at the completion of 
chemotherapy as an index of residual disease. Surveillance CA125 
measurements are generally obtained every 3 months for 2 years, 
every 6 months for the next 3 years, and yearly thereafter. CA125 
levels are also an important indicator of a patient's response to 
therapy in the presence of advanced or recurrent disease. In this 
setting, CA125 levels may be obtained prior to each treatment cycle.

Limitations

    These services are not covered for the evaluation of patients 
with signs or symptoms suggestive of malignancy. The service may be 
ordered at times necessary to assess either the presence of 
recurrent disease or the patient's response to treatment with 
subsequent treatment cycles.
    CA125 is specifically not covered for aiding in the differential 
diagnosis of patients with a pelvic mass as the sensitivity and 
specificity of the test is not sufficient. In general, a single 
``tumor marker'' will suffice in following a patient with one of 
these malignancies.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
180.0...............................................  Malignant neoplasm, endocervix.
182.0...............................................  Malignant neoplasm of corpus uteri, except isthmus.
183.0...............................................  Malignant neoplasm,ovary.
183.2...............................................  Malignant neoplasm, fallopian tube.
183.8...............................................  Malignant neoplasm, other specified sites of uterine
                                                       adnexa.
184.8...............................................  Malignant neoplasm, other specified sites of female
                                                       genital organs.
198.6...............................................  Secondary malignant neoplasm, ovary.
198.82..............................................  Secondary malignancy of genital organs.
236.0-236.3.........................................  Neoplasm of uncertain behavior of female genital organs.
V10.43-V10.44.......................................  Personal history of malignant neoplasm of female genital
                                                       organs.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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 13152]]

 
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

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

Sources of Information

    Clinical Pancreatic Guideline for the Use of Tumor Markers in 
Breast and Colorectal Cancer, American Society of Clinical Oncology. 
J Clin Oncol 14:2843-2877, 1996.
    Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR 
Radioimmunoassay for Early Detection of Breast Cancer Recurrence in 
Patients with Stage II and Stage III Disease. J Clin Oncol 1977, 
15(6):2322-2328.

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.

Documentation Requirements

    Indicated if service request for CA125 is requested more 
frequently than stipulated.

Medicare National Coverage Decision for Tumor Antigen by 
Immunoassay CA15-3/CA27.29

Other Names/Abbreviations

Description

    Immunoassay determinations of the serum levels of certain 
proteins or carbohydrates serve as tumor markers. When elevated, 
serum concentration of these markers may reflect tumor size and 
grade.
    This policy specifically addresses the following tumor antigens: 
CA15-3 and CA27.29

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
Not yet assigned....................................  Tumor antigen CA15-3/CA27.29.
----------------------------------------------------------------------------------------------------------------

Indications

    Multiple tumor markers are available for monitoring the response 
of certain malignancies to therapy and assessing whether residual 
tumor exists postsurgical therapy.
    CA 15-3 is often medically necessary to aid in the management of 
patients with breast cancer. Serial testing must be used in 
conjunction with other clinical methods for monitoring breast 
cancer. For monitoring, if medically necessary, use consistently 
either CA 15-3 or CA 27.29, not both.
    CA 27.29 is equivalent to CA 15-3 in its usage in management of 
patients with breast cancer.

Limitations

    These services are not covered for the evaluation of patients 
with signs or

[[Page 13153]]

symptoms suggestive of malignancy. The service may be ordered at 
times necessary to assess either the presence of recurrent disease 
or the patient's response to treatment with subsequent treatment 
cycles.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                         Code                                                 Description
----------------------------------------------------------------------------------------------------------------
174.0-174.9..........................................  Breast, primary (female)--malignant neoplasm of female
                                                        breast.
175.0-175.9..........................................  Breast, primary (male)--malignant neoplasm of male breast
198.2................................................  Secondary malignant neoplasm (male breast).
198.81...............................................  Secondary malignant neoplasm (female breast).
V10.3................................................  Personal history of malignant neoplasm, breast.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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, leukemi.
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.
----------------------------------------------------------------------------------------------------------------


[[Page 13154]]

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

Code    Description

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

Sources of Information

    Clinical Pancreatic Guideline for the Use of Tumor Markers in 
Breast and Colorectal Cancer, American Society of Clinical Oncology. 
J Clin Oncol 14:2843-2877, 1996.
    Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR 
Radioimmunoassay for Early Detection of Breast Cancer Recurrence in 
Patients with Stage II and Stage III Disease. J Clin Oncol 1977, 
15(6):2322-2328.
    Bone GG, von Mensdorff-Pouilly S, Kenemans P, van Kamp GJ, et 
al. Clinical and Technical Evaluation of ACS BR Serum Assay of MUC-1 
Gene Derived Glycoprotein in Breast Cancer, and Compared with CA15-3 
Assays. Clin Chem 1997, 43(4):585-593.

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 Tumor Antigen by 
Immunoassay CA19-9

Other Names/Abbreviations

Description

    Immunoassay determinations of the serum levels of certain 
proteins or carbohydrates serve as tumor markers. When elevated, 
serum concentration of these markers may reflect tumor size and 
grade.
    This policy specifically addresses the following tumor antigen: 
CA19-9.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
Not yet assigned....................................  Tumor antigen CA19-9.
----------------------------------------------------------------------------------------------------------------

Indications

    Multiple tumor markers are available for monitoring the response 
of certain malignancies to therapy and assessing whether residual 
tumor exists post-surgical therapy.
    Levels are useful in following the course of patients with 
established diagnosis of pancreatic and biliary ductal carcinoma. 
The test is not indicated for diagnosing these two diseases.

Limitations

    These services are not covered for the evaluation of patients 
with signs or symptoms suggestive of malignancy. The service may be 
ordered at times necessary to assess either the presence of 
recurrent disease or the patient's response to treatment with 
subsequent treatment cycles.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
155.1...............................................  Malignant neoplasm, intrahepatic bile ducts.
156.1...............................................  Malignant neoplasm, extrahepatic bile ducts.
156.8...............................................  Malignant neoplasm, other specified sites of gallbladder
                                                       and extrahepatic bile ducts.
156.9...............................................  Malignant neoplasm, unspecified part of biliary tract.
157.0-157.9.........................................  Malignant neoplasm, pancreas.
197.8...............................................  Secondary malignant neoplasm, other digestive organs and
                                                       spleen.
235.3...............................................  Neoplasm of uncertain behavior, liver and biliary
                                                       passages.
235.5...............................................  Neoplasm of uncertain behavior, other and unspecified
                                                       digestive organs.
V10.09..............................................  Other personal history of cancer.
----------------------------------------------------------------------------------------------------------------

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

[[Page 13155]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    Clinical Pancreatic Guideline for the Use of Tumor Markers in 
Breast and Colorectal Cancer, American Society of Clinical Oncology. 
J Clin Oncol 14:2843-2877, 1996.
    Richter JM, Christensen MR, Rustgi AK, and Silverstein MD. The 
Clinical Utility of the CA19-9 Radioimmunoassay for the Diagnosis of 
Pancreatic Cancer Presenting as Pain or Weight Loss: A Cost 
Effective Analysis. Arch Intern Med 1989, 149:2292-2297.
    Safi F, SchlosseW, Falkenreck S, et al. Prognostic Value of CA 
19-9 Serum Course in Pancreatic Cancer. Hepaetogastroenterology 1998 
Jan-Feb; 45(19):253-9.

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,

[[Page 13156]]

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 Prostate Specific Antigen

    Other Names/Abbreviations: Total PSA.

Description

    PSA, a tumor marker for adenocarcinoma of the prostate, can 
predict residual tumor in the post-operative phase of prostate 
cancer. Three to six months after radical prostatectomy, PSA is 
reported to provide a sensitive indicator of persistent disease. Six 
months following introduction of antiandrogen therapy, PSA is 
reported as capable of distinguishing patients with favorable 
response from those in whom limited response is anticipated.
    PSA when used in conjunction with other prostate cancer tests, 
such as digital rectal examination, may assist in the decision 
making process for diagnosing prostate cancer. PSA also, serves as a 
marker in following the progress of most prostate tumors once a 
diagnosis has been established. This test is also an aid in the 
management of prostate cancer patients and in detecting metastatic 
or persistent disease in patients following treatment.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
84153...............................................  Prostate Specific Antigen (PSA), total
----------------------------------------------------------------------------------------------------------------

Indications

    PSA is of proven value in differentiating benign from malignant 
disease in men with lower urinary tract signs and symptoms (e.g., 
hematuria, slow urine stream, hesitancy, urgency, frequency, 
nocturia and incontinence) as well as with patients with palpably 
abnormal prostate glands on physician exam, and in patients with 
other laboratory or imaging studies that suggest the possibility of 
a malignant prostate disorder. PSA is also a marker used to follow 
the progress of prostate cancer once a diagnosis has been 
established, such as in detecting metastatic or persistent disease 
in patients who may require additional treatment. PSA testing may 
also be useful in the differential diagnosis of men presenting with 
as yet undiagnosed disseminated metastatic disease.

Limitations

    Generally, for patients with lower urinary tract signs or 
symptoms, the test is performed only once per year unless there is a 
change in the patient's medical condition.
    Testing with a diagnosis of in situ carcinoma is not reasonably 
done more frequently than once, unless the result is abnormal, in 
which case the test may be repeated once.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
185.................................................  Malignant neoplasm of prostate.
188.5...............................................  Malignant neoplasm of bladder neck.
196.5...............................................  Secondary malignant neoplasm, lymph nodes inguinal region
                                                       and lower limb.
196.6...............................................  Secondary malignant neoplasm, intrapelvic lymph nodes.
196.8...............................................  Secondary malignant neoplasm, lymph nodes of multiple
                                                       sites.
198.5...............................................  Secondary malignant neoplasm, bone and bone marrow.
198.82..............................................  Secondary malignant neoplasm, genital organs.
233.4...............................................  Carcinoma in situ, prostate.
239.5...............................................  Neoplasm of unspecified nature, other genitourinary
                                                       organs.
596.0...............................................  Bladder neck obstruction.
599.7...............................................  Hematuria.
601.9...............................................  Unspecified prostatitis.
602.9...............................................  Unspecified disorder of prostate.
788.20..............................................  Retention of urine, unspecified.
788.21..............................................  Incomplete bladder emptying.
790.93..............................................  Elevated prostate specific antigen.
793.6/793.7.........................................  Non-specific abnormal result of radiologic examination,
                                                       evidence of malignancy.
794.9...............................................  Bone scan evidence of malignancy.
V10.46..............................................  Personal history of malignant neoplasm; prostate.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an FDA approval or clearance will be 
denied as not reasonable and necessary if FDA approval or clearance

[[Page 13157]]

has not been obtained, except for those having a Category B 
Investigational Device Exemption (IDE). Coverage of Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    Laboratory Test Handbook, 3rd edition, pp. 338-340.
    Cooner WH, Mosley BR, Rutherford CL, et al. Prostate Cancer 
Detection in a Clinical Urological Practice by Ultrasonography, 
Digital Rectal Examination and Prostate Specific Antigen. 
J.Urol.1990;143: 1146-1154.

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.
    6. To show elevated PSA, use ICD-9-CM code 790.93 (Elevated 
prostate specific antigen). If a more specific diagnosis code has 
been made, use the code for that diagnosis.

Medicare National Coverage Decision for Gamma Glutamyl Transferase

    Other Names/Abbreviations: GGT.

Description

    Gamma glutamyltransferase (GGT) is an intracellular enzyme that 
appears in blood following leakage from cells. Renal tubules, liver, 
and pancreas contain high amounts, although the measurement of GGT 
in serum is almost always used for assessment of

[[Page 13158]]

hepatobiliary function. Unlike other enzymes which are found in 
heart, skeletal muscle, and intestinal mucosa as well as liver, the 
appearance of an elevated level of GGT in serum is almost always the 
result of liver disease or injury. It is specifically useful to 
differentiate elevated alkaline phosphatase levels when the source 
of the alkaline phosphatase increase (bone, liver, or placenta) is 
unclear. The combination of high alkaline phosphatase and a normal 
GGT does not, however, rule out liver disease completely.
    As well as being a very specific marker of hepatobiliary 
function, GGT is also a very sensitive marker for hepatocellular 
damage. Abnormal concentrations typically appear before elevations 
of other liver enzymes or bilirubin are evident. Obstruction of the 
biliary tract, viral infection (e.g., hepatitis, mononucleosis), 
metastatic cancer, exposure to hepatotoxins (e.g., organic solvents, 
drugs, alcohol), and use of drugs that induce microsomal enzymes in 
the liver (e.g., cimetidine, barbiturates, phenytoin, and 
carbamazepine) all can cause a moderate to marked increase in GGT 
serum concentration. In addition, some drugs can cause or exacerbate 
liver dysfunction (e.g., atorvastatin, troglitazone, and others as 
noted in FDA Contraindications and Warnings.)
    GGT is useful for diagnosis of liver disease or injury, 
exclusion of hepatobiliary involvement related to other diseases, 
and patient management during the resolution of existing disease or 
following injury.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82977...............................................  Glutamyltransferase, gamma (GGT).
----------------------------------------------------------------------------------------------------------------

Indications

    1. To provide information about known or suspected hepatobiliary 
disease, for example:
    a. following chronic alcohol or drug ingestion;
    b. following exposure to hepatotoxins;
    c. when using medication known to have a potential for causing 
liver toxicity (e.g., following the drug manufacturer's 
recommendations); or
    d. following infection (e.g., viral hepatitis and other specific 
infections such as amebiasis, tuberculosis, psittacosis, and similar 
infections)
    2. To assess liver injury/function following diagnosis of 
primary or secondary malignant neoplasms
    3. To assess liver injury/function in a wide variety of 
disorders and diseases known to cause liver involvement (e.g., 
diabetes mellitus, malnutrition, disorders of iron and mineral 
metabolism, sarcoidosis, amyloidosis, lupus, and hypertension)
    4. To assess liver function related to gastrointestinal disease
    5. To assess liver function related to pancreatic disease
    6. To assess liver function in patients subsequent to liver 
transplantation
    7. To differentiate between the different sources of elevated 
alkaline phosphatase activity

Limitations

    When used to assess liver dysfunction secondary to existing non-
hepatobiliary disease with no change in signs, symptoms, or 
treatment, it is generally not necessary to repeat a GGT 
determination after a normal result has been obtained unless new 
indications are present.
    If the GGT is the only ``liver'' enzyme abnormally high, it is 
generally not necessary to pursue further evaluation for liver 
disease for this specific indication.
    When used to determine if other abnormal enzyme tests reflect 
liver abnormality rather than other tissue, it generally is not 
necessary to repeat a GGT more than one time per week.
    Because of the extreme sensitivity of GGT as a marker for 
cytochrome oxidase induction or cell membrane permeability, it is 
generally not useful in monitoring patients with known liver 
disease.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
003.1...............................................  Salmonella septicemia.
006.0-.9............................................  Amebiasis.
014.00-.86..........................................  Tuberculosis of intestines, peritoneum, and mesenteric
                                                       glands.
017.90-.96..........................................  Tuberculosis of other specified organs.
018.90-.96..........................................  Miliary tuberculosis, unspecified.
020.0-.9............................................  Plague.
022.3...............................................  Anthrax septicemia.
027.0...............................................  Listeriosis.
027.1...............................................  Erysipelothrix infection.
030.1...............................................  Tuberculoid leprosy [Type T].
032.83..............................................  Diphtheritic peritonitis.
036.1...............................................  Meningococcal encephalitis.
036.2...............................................  Meningococcemia.
038.0-.9............................................  Septicemia.
039.2...............................................  Actinomycotic infections, abdominal.
040.0...............................................  Gas gangrene.
042.................................................  Human immunodeficiency virus (HIV) disease.
054.0...............................................  Eczema herpeticum.
054.5...............................................  Herpetic septicemia.
060.0-.1............................................  Yellow fever.
070.0-.9............................................  Viral hepatitis.
072.71..............................................  Mumps hepatitis.
073.0...............................................  Ornithosis, with pneumonia.
074.8...............................................  Other specified diseases due to Coxsackie virus.
075.................................................  Infectious mononucleosis.
078.5...............................................  Cytomegaloviral disease.
079.99..............................................  Unspecified viral infection.
082.0-.9............................................  Tick-borne rickettsioses, stet.
084.9...............................................  Other pernicious complications of malaria.
086.1...............................................  Chagas disease with organ involvement other than heart.
088.81..............................................  Lyme disease.
091.62..............................................  Secondary syphilitic hepatitis.
095.3...............................................  Syphilis of liver.
100.0...............................................  Leptospirosis icterohemorrhagica.

[[Page 13159]]

 
112.5...............................................  Candidiasis, disseminated.
115.00..............................................  Infection by Histoplasma capsulatum without mention of
                                                       manifestation.
120.9...............................................  Schistosomiasis, unspecified.
121.1...............................................  Clonorchiasis.
121.3...............................................  Fascioliasis.
122.0...............................................  Echinococcus granulosus infection of liver.
122.5...............................................  Echinococcus multilocularis infection of liver.
122.8...............................................  Echinococcosis, unspecified, of liver.
122.9...............................................  Echinococcus, other and unspecified.
130.5...............................................  Hepatitis due to toxoplasmosis.
135.................................................  Sarcoidosis.
150.0-159.9.........................................  Malignant neoplasm of digestive organs and peritoneum.
160.0-165.9.........................................  Malignant neoplasm of respiratory and intrathoracic
                                                       organs.
170.0-176.9.........................................  Malignant neoplasm of bone, connective tissue, skin, and
                                                       breast.
179-189.9...........................................  Malignant neoplasm of genitourinary organs.
200.00-208.91.......................................  Malignant neoplasm of lymphatic and hematopoietic tissue.
211.5...............................................  Benign neoplasm of liver and biliary passages.
211.6...............................................  Benign neoplasm of pancreas, except islets of Langerhans.
211.7...............................................  Benign neoplasm of islets of Langerhans.
228.04..............................................  Hemangioma of intra-abdominal structures.
230.8...............................................  Carcinoma in situ of liver and biliary system.
235.0-238.9.........................................  Neoplasms of uncertain behavior.
239.0...............................................  Neoplasm of unspecified nature of digestive system.
250.00-.93..........................................  Diabetes mellitus.
252.0...............................................  Hyperparathyroidism.
263.1...............................................  Malnutrition of mild degree.
263.9...............................................  Unspecified protein-calorie malnutrition.
268.0...............................................  Rickets, active.
268.2...............................................  Osteomalacia, unspecified.
269.0...............................................  Deficiency of vitamin K.
270.2...............................................  Other disturbances of aromatic amino acid metabolism.
270.9...............................................  Unspecified disorder of amino acid metabolism.
271.0...............................................  Glycogenosis.
272.0...............................................  Pure hypercholesterolemia.
272.1...............................................  Pure hyperglyceridemia.
272.2...............................................  Mixed hyperlipidemia.
272.4...............................................  Other and unspecified hyperlipidemia.
272.7...............................................  Lipidoses.
272.9...............................................  Unspecified disorder of lipoid metabolism.
275.0...............................................  Disorders of iron metabolism.
275.1...............................................  Disorders of copper metabolism.
275.3...............................................  Disorders of phosphorus metabolism.
275.40-.49..........................................  Disorders of calcium metabolism.
277.1...............................................  Disorders of porphyrin metabolism.
277.3...............................................  Amyloidosis.
277.4...............................................  Disorders of bilirubin excretion.
277.6...............................................  Other deficiencies of circulating enzymes.
282.60-.69..........................................  Sickle cell anemia.
286.6...............................................  Defibrination syndrome.
286.7...............................................  Acquired coagulation factor deficiency.
289.4...............................................  Hypersplenism.
291.0-.9............................................  Alcoholic psychoses.
303.00-.03..........................................  Acute alcoholic intoxication.
303.90-.93..........................................  Other and unspecified alcohol dependence.
304.0-.9............................................  Drug dependence.
305.00-.93..........................................  Non-dependent abuse of drugs.
357.5...............................................  Alcoholic polyneuropathy.
359.2...............................................  Myotonic disorders.
452.................................................  Portal vein thrombosis.
453.0-.9............................................  Other vein embolism and thrombosis.
456.0-.21...........................................  Esophageal varices.
555.0-.9............................................  Regional enteritis.
556.0-.9............................................  Ulcerative colitis.
557.0...............................................  Acute vascular insufficiency of intestine.
558.1-.9............................................  Other noninfectious gastroenteritis and colitis.
560.0-.9............................................  Intestinal obstruction without mention of hernia.
562.01..............................................  Diverticulitis of small intestine (without mention of
                                                       hemorrhage).
562.03..............................................  Diverticulitis of small intestine with hemorrhage.
562.11..............................................  Diverticulitis of colon (without mention of hemorrhage).
562.13..............................................  Diverticulitis of colon with hemorrhage.
567.0-.9............................................  Peritonitis.
569.83..............................................  Perforation of intestine.
570.................................................  Acute and subacute necrosis of liver.
571.0-.9............................................  Chronic liver disease and cirrhosis.

[[Page 13160]]

 
572.0-.8............................................  Liver abscess and sequelae of chronic liver disease.
573.0-.9............................................  Other disorders of liver.
574.00-.91..........................................  Cholelithiasis.
575.0-.9............................................  Other disorders of gallbladder.
576.0-.9............................................  Other disorders of biliary tract.
581.0-.9............................................  Nephrotic syndrome.
582.0-.9............................................  Chronic glomerulonephritis.
583.0-.9............................................  Nephritis and nephropathy not specified as acute or
                                                       chronic.
584.5-.9............................................  Acute renal failure.
585.................................................  Chronic renal failure.
586.................................................  Renal failure, unspecified.
587.................................................  Renal sclerosis, unspecified.
588.0-.9............................................  Disorders resulting from impaired renal function
590.00-.9...........................................  Infections of kidney.
646.7...............................................  Liver disorders in pregnancy.
960.0-979.9.........................................  Poisoning by drugs, medicinal, and biological substances.
980.0-989.89........................................  Toxic effects of substances chiefly nonmedical as to
                                                       source.
V58.61-.69..........................................  Long term (current) drug use.
V67.1...............................................  Follow-up examination, radiotherapy.
V67.2...............................................  Follow-up examination, chemotherapy.
V67.51..............................................  Follow-up examination after completed treatment with high-
                                                       risk medications, not elsewhere classified.
----------------------------------------------------------------------------------------------------------------

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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.

[[Page 13161]]

 
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

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

Sources of Information

    Ockner, R.K., ``Clinical approach to liver disease,'' in 
Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine 
(18th ed.), 1988, W.B. Saunders, pp. 808-809.
    Ockner, R.K., ``Laboratory tests in liver disease,'' in 
Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine 
(18th ed.), 1988, W.B. Saunders, pp. 814-817.
    Gornall, A.G., and Goldberg, D.M., ``Hepatobiliary Disorders,'' 
in Gornall, A.G. (ed.)., Applied Biochemistry of Clinical Disorders 
(2nd ed.), 1986, J.B. Lippincott, pp. 211-246.
    Scharschmidt, B.F., ``Parasitic, bacterial, fungal, and 
granulomatous liver disease,'' in Wyngaarden, J.B., and Smith, L.H. 
(eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, 
pp. 834-838.
    Pincus, M.R., and Schaffner, J.A., ``Assessment of liver 
function,'' in Henry, J.B. (ed.), Clinical Diagnosis and Management 
by Laboratory Methods (19th ed.), 1996, W.B. Saunders, pp. 253-267.
    Bordley, D.R., Nattinger, A.B., et al., ``Gastrointestinal, 
Hepatobiliary, and Pancreatic Problems,'' in Panzer, R.J., Black, 
E.R., and Griner, P.F. (eds.), Diagnostic Strategies for Common 
Medical Problems, 1991, American College of Physicians, pp. 94-185.
    Tietz, N.W. (ed.), Clinical Guide to Laboratory Tests (3rd ed.), 
1995, pp. 286-287.
    Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B. 
Saunders.
    Dufour, D.R., Clinical Use of Laboratory Data: A Practical 
Guide, 1998, Williams and Wilkins, pp. 142-155.
    Harrison's Principles of Internal Medicine (14th ed.), 1998, 
McGraw Hill.
    Wallach, J., Interpretation of Diagnostic Tests, 1996, Little 
Brown and Co.
    Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, 
Springhouse Corporation.
    Sleisenger and Fordtrans's Gastrointestinal and Liver Disease 
(6th ed.), 1997, W.B. Saunders.

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.

Medicare National Coverage Decision for Hepatitis Panel

Description

    This panel consists of the following tests:
    Hepatitis B surface antigen (HBsAg) (CPT 87340).
    Hepatitis C antibody (CPT 86803).
    Hepatitis B core antibody (HBcAb), IgM Antibody (CPT 86705).
    Hepatitis A antibody (HAAb), IgM Antibody (CPT 86709).
    Hepatitis is an inflammation of the liver resulting from 
viruses, drugs, toxins, and other etiologies. Viral hepatitis can be 
due to one of at least five different viruses, designated Hepatitis 
A, B, C, D, and E. Most cases are caused by Hepatitis A virus (HAV), 
Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
    HAV is the most common cause of hepatitis in children and 
adolescents in the United States. Prior exposure is indicated by a 
positive IgG anti-HAV. Acute HAV is diagnosed by IgM anti-HAV, which 
typically appears within four weeks of exposure, and which 
disappears within three months of its appearance. IgG anti-HAV is 
similar in the timing of its appearance, but it persists 
indefinitely. Its detection indicates prior effective immunization 
or recovery from infection. Although HAV is spread most commonly by 
fecal-oral exposure, parenteral infection is possible during the 
acute viremia stage of the disease. After exposure, standard immune 
globulin may be effective as a prophylaxis.
    HBV produces three separate antigens (surface, core, and e 
(envelope) antigens) when it infects the liver, although only 
hepatitis B surface antigen (HBsAg) is included as part of this 
panel. Following exposure, the body normally responds by producing 
antibodies to each of these antigens; one of which is included in 
this panel: Hepatitis B surface antibody (HBsAb)-IgM antibody , 
HBsAg is the earlier marker, appearing in serum four to eight weeks 
after exposure, and typically disappearing within six months after 
its appearance. If HBsAg remains detectable for greater than six 
months, this indicates chronic HBV infection. HBcAb, in the form of 
both IgG and IgM antibodies, are next to appear in serum, typically 
becoming detectable two to three months following exposure. The IgM 
antibody gradually declines or disappears entirely one to two years 
following exposure, but the IgG usually remains detectable for life. 
Because HBsAg is present for a relatively short period and usually 
displays a low titer, a negative result does not exclude an HBV 
diagnosis. HBcAb, on the other hand, rises to a much higher titer 
and remains elevated for a longer period of time, but a positive 
result is not diagnostic of acute disease, since it may be the 
result of a prior infection. The last

[[Page 13162]]

marker to appear in the course of a typical infection is HBsAb, 
which appears in serum four to six months following exposure, 
remains positive indefinitely, and confers immunity. HBV is spread 
exclusively by exposure to infected blood or body fluids; in the 
U.S., sexual transmission accounts for 30% to 60% of new cases of 
HBV infection.
    The diagnosis of acute HBV infection is best established by 
documentation of a positive IgM antibody against the core antigen 
(HBcAb-IgM) and by identification of a positive hepatitis B surface 
antigen (HBsAg). The diagnosis of chronic HBV infection is 
established primarily by identifying a positive hepatitis B surface 
antigen (HBsAg) and demonstrating positive IgG antibody directed 
against the core antigen (HBcAb-IgG). Additional tests such as 
Hepatitis B e antigen (HBeAg) and Hepatitis B e antibody (HBeAb), 
the envelope antigen and antibody, are not included in the Hepatitis 
Panel, but may be of importance in assessing the infectivity of 
patients with HBV. Following completion of a HBV vaccination series, 
HBsAb alone may be used monthly for up to six months, or until a 
positive result is obtained, to verify an adequate antibody 
response.
    HCV is the most common cause of post-transfusion hepatitis; 
overall HCV is responsible for 15% to 20% of all cases of acute 
hepatitis, and is the most common cause of chronic liver disease. 
The test most commonly used to identify HCV measures HCV antibodies, 
which appear in blood two to four months after infection. False 
positive HCV results can occur. For example, a patient with a recent 
yeast infection may produce a false positive anti-HCV result. For 
this reason, at present positive results usually are confirmed by a 
more specific technique. Like HBV, HCV is spread exclusively through 
exposure to infected blood or body fluids.
    This panel of tests is used for differential diagnosis in a 
patient with symptoms of liver disease of injury. When the time of 
exposure or the stage of the disease is not known, a patient with 
continued symptoms of liver disease despite a completely negative 
Hepatitis Panel may need a repeat panel approximately two weeks to 
two months later to exclude the possibility of hepatitis. Once a 
diagnosis is established, specific tests can be used to monitor the 
course of the disease.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
80059...............................................  Hepatitis Panel.
----------------------------------------------------------------------------------------------------------------

Indications

    1. To detect viral hepatitis infection when there are abnormal 
liver function test results, with or without signs or symptoms of 
hepatitis.
    2. Prior to and subsequent to liver transplantation.

Limitations

    After a hepatitis diagnosis has been established, only 
individual tests, rather than the entire panel, are needed.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
070.0-.9............................................  Viral hepatitis.
456.0-.21...........................................  Esophageal varices with or without mention of bleeding.
570.................................................  Acute and subacute necrosis of liver.
571.5...............................................  Cirrhosis of liver without mention of alcohol.
572.0-.8............................................  Liver abscess and sequelae of chronic liver disease.
573.3...............................................  Hepatitis, unspecified.
780.31..............................................  Febrile convulsions.
780.71..............................................  Chronic fatigue syndrome.
780.79..............................................  Other malaise and fatigue.
782.4...............................................  Jaundice, unspecified, not of newborn.
783.0-.6............................................  Symptoms concerning nutrition, metabolism, and
                                                       development.
784.69..............................................  Other symbolic dysfunction.
787.01-.03..........................................  Nausea and vomiting.
789.00-.09..........................................  Abdominal pain.
789.1...............................................  Hepatomegaly.
789.6...............................................  Localized abdominal tenderness (RUQ).
794.8...............................................  Nonspecific abnormal results of function studies, liver.
999.3...............................................  Other infection following infusion, injection, trans
                                                       fusion, or vaccination.
996.82..............................................  Complications of transplanted organ, liver.
V72.85..............................................  Liver transplant recipient evaluation.
----------------------------------------------------------------------------------------------------------------

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

[[Page 13163]]

Laboratory Improvement Act of 1988 (CLIA) certificate for the 
testing performed will result in denial of claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    Ockner, R.K., ``Approaches to the diagnosis of jaundice,'' in 
Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine 
(18th ed.), 1988, W.B. Saunders, pp. 817-818.
    Ockner, R.K., ``Acute viral hepatitis,'' in Wyngaarden, J.B., 
and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, 
W.B. Saunders, pp. 818-826.
    Ockner, R.K., ``Chronic hepatitis,'' in Wyngaarden, J.B., and 
Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, 
W.B. Saunders, pp. 830-834.
    Arvan, D.A., ``Acute viral hepatitis,'' in Panzer, R.J., Black, 
E.R., and Griner, P.F. (eds.), Diagnostic Strategies for Common 
Medical Problems, 1991, American College of Physicians, pp. 141-151.
    Goldberg, D.M., ``Diagnostic Enzymology,'' in Gornall, A.G. 
(ed.), Applied Biochemistry of Clinical Disorders (2nd ed.), 1986, 
J.B. Lippincott, pp. 33-51.
    Pincus, M.R., and Schaffner, J.A., ``Assessment of liver 
function,'' in Henry, J.B. (ed.), Clinical Diagnosis and Management 
by Laboratory Methods (19th ed.), 1996, W.B. Saunders, pp. 253-267.
    Tietz, N.W. (ed.), Clinical Guide to Laboratory Tests (3rd ed.), 
1995, pp. 320-327.
    Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B. 
Saunders.
    Harrison's Principles of Internal Medicine (14th ed.), 1998, 
McGraw Hill.
    Wallach, J., Interpretation of Diagnostic Tests, 1996, Little 
Brown and Co.
    Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, 
Springhouse Corporation.
    Sleisenger and Fordtrans's Gastrointestinal and Liver Disease 
(6th ed.), 1997, W.B. Saunders.

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

[[Page 13164]]

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.

Medicare National Coverage Decision for Fecal Occult Blood

Description

    The fecal occult blood test detects the presence of trace 
amounts of blood in stool. The procedure is performed by testing one 
or several small samples of one, two or three different stool 
specimens.
    This test may be performed with or without evidence of iron 
deficiency anemia, which may be related to gastrointestinal blood 
loss. The range of causes for blood loss include inflammatory 
causes, including acid-peptic disease, non-steroidal anti-
inflammatory drug use, hiatal hernia, Crohn's disease, ulcerative 
colitis, gastroenteritis, and colon ulcers. It is also seen with 
infectious causes, including hookworm, stronglyoidal ascariasis, 
tuberculosis, and enteroamebiasis. Vascular causes include 
angiodysplasia, hemangiomas, varices, blue rubber bleb nevus 
syndrome, and watermelon stomach. Tumors and neoplastic causes 
include lymphoma, leiomyosarcoma, lipomas, adenocarcinoma and 
primary and secondary metastases to the GI tract. Drugs such as 
nonsteroidal anti-inflammatory drugs also cause bleeding. There are 
extra gastrointestinal causes such as hemoptysis, epistaxis, and 
oropharyngeal bleeding. Artifactual causes include hematuria, and 
menstrual bleeding. In addition, there may be other causes such as 
coagulopathies, gastrostomy tubes or other appliances, factitial 
causes, and long distance running.
    Three basic types of fecal hemoglobin assays exist, each 
directed at a different component of the hemoglobin molecule.
    (1) Immunoassays recognize antigenic sites on the globin portion 
and are least affected by diet or proximal gut bleeding, but the 
antigen may be destroyed by fecal flora.
    (2) The heme-porphyrin assay measures heme-derived porphyrin and 
is least influenced by enterocolic metabolism or fecal storage. This 
assay does not discriminate dietary from endogenous heme. The 
capacity to detect proximal gut bleeding reduces its specificity for 
colorectal cancer screening but makes it more useful for evaluating 
overall GI bleeding in case finding for iron deficiency anemia.
    (3) The guaiac-based test is the most widely used. It requires 
the peroxidase activity of an intact heme moiety to be reactive. 
Positivity rates fall with storage. Fecal hydration such as adding a 
drop of water increases the test reactivity but also increases false 
positivity.
    Of these three tests, the guaiac-based test is the most 
sensitive for detecting lower bowel bleeding. Because of this 
sensitivity, it is advisable, when it is used for screening, to 
defer the guaiac-based test if other studies of the colon are 
performed prior to the test. Similarly, this test's sensitivity may 
result in a false positive if the patient has recently ingested 
meat. Both of these cautions are appropriate when the test is used 
for screening, but when appropriate indications are present, the 
test should be done despite its limitations.

HCPCS Codes (Alpha numeric, CPT  AMA):

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82270...............................................  Blood, occult; feces, 1-3 simultaneous determinations.
----------------------------------------------------------------------------------------------------------------

Indications

    1. To evaluate known or suspected alimentary tract conditions 
that might cause bleeding into the intestinal tract.
    2. To evaluate unexpected anemia.
    3. To evaluate abnormal signs, symptoms, or complaints that 
might be associated with loss of blood.
    4. To evaluate patient complaints of black or red-tinged stools.

Limitations

    1. Code 82270 is reported once for the testing of up to three 
separate specimens (comprising either one or two tests per 
specimen).
    2. In patients who are taking non-steroidal anti-inflammatory 
drugs and have a history of gastrointestinal bleeding but no other 
signs, symptoms, or complaints associated with gastrointestinal 
blood loss, testing for occult blood may generally be appropriate no 
more than once every three months.
    3. When testing is done for the purpose of screening for 
colorectal cancer in the absence of signs, symptoms, conditions, or 
complaints associated with gastrointestinal blood loss, HCPCS code 
G0107 (Colorectal cancer screening; fecal-occult blood test, 1-3 
simultaneous determinations) should be used. Coverage of colorectal 
cancer screening is described in HCFA Program Memorandum Transmittal 
No. AB-97-24 (November, 1997).

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
                        Code                                                  Description
----------------------------------------------------------------------------------------------------------------
004.0-.9............................................  Shigellosis.
005.0-.9............................................  Other food poisoning (bacterial).
006.0-.9............................................  Amebiasis.
007.0-.9............................................  Other protozoal intestinal diseases.
008.41-.49..........................................  Intestinal infections due to other specified bacteria.
009.0-.3............................................  Ill defined intestinal infections.
014.00-.86..........................................  Tuberculosis of intestines, peritoneum, and mesenteric
                                                       glands.
022.2...............................................  Gastrointestinal anthrax.
040.2...............................................  Whipple's disease.
123.0-.9............................................  Other cestode infection.
124.................................................  Trichinosis.
127.0-.9............................................  Other intestinal helminthiases.
150.0-157.9.........................................  Malignant neoplasm of digestive organisms.
176.3...............................................  Kaposi's sarcoma, gastrointestinal sites.
197.4-.5............................................  Secondary malignant neoplasm of intestines.
197.8...............................................  Secondary malignant neoplasm of other digestive organs and
                                                       spleen.
199.0...............................................  Disseminated malignant neoplasm.
204.00-.91..........................................  Lymphoid leukemia.
205.00-208.91.......................................  Leukemia.
211.0-.9............................................  Benign neoplasm of other parts of digestive system.
228.04..............................................  Hemangioma of intra-abdominal structures.
230.2-.9............................................  Carcinoma in situ of digestive organs.

[[Page 13165]]

 
235.2...............................................  Neoplasm of uncertain behavior of stomach, intestines, and
                                                       rectum.
235.5...............................................  Neoplasm of uncertain behavior of other and unspecified
                                                       digestive organs.
239.0...............................................  Neoplasm of unspecified nature, digestive system.
280.0-.9............................................  Iron deficiency anemias.
285.0-.9............................................  Other and unspecified anemias.
286.0-.9............................................  Coagulation defects.
287.0-.9............................................  Purpura and other hemorrhagic conditions.
448.0...............................................  Hereditary hemorrhagic telangiectasia.
455.0-.8............................................  Hemorrhoids.
456.0-.21...........................................  Esophageal varices with or without mention of bleeding.
530.10-535.61.......................................  Diseases of the esophagus, stomach, and duodenum.
536.2...............................................  Persistent vomiting.
536.8-.9............................................  Dyspepsia and other specified and unspecified functional
                                                       disorders of the stomach.
537.0-.4............................................  Other disorders of stomach and duodenum.
537.82-.83..........................................  Angiodysplasia of stomach and duodenum.
537.89..............................................  Other specified disorders of stomach and duodenum.
555.0-558.9.........................................  Non-infectious enteritis and colitis.
560.0-.39...........................................  Intestinal obstruction/impaction without mention of
                                                       hernia.
562.10-.13..........................................  Diverticulosis/diverticulitis of colon.
564.0-.9............................................  Functional digestive disorders, not elsewhere classified.
565.0-.1............................................  Anal fissure and fistula.
569.0...............................................  Anal and rectal polyp.
569.1...............................................  Rectal prolapse.
569.3...............................................  Hemorrhage of rectum and anus.
569.41-.49..........................................  Other specified disorders of rectum and anus.
569.84-.85..........................................  Angiodysplasia of intestine with or wihout mention of
                                                       hemorrhage.
571.0-.9............................................  Chronic liver disease and cirrhosis.
577.0...............................................  Acute pancreatitis.
577.0-.9............................................  Diseases of the pancreas.
578.0-.9............................................  Gastrointestinal hemorrhage.
579.0...............................................  Celiac disease.
579.8...............................................  Other specified intestinal malabsorption.
617.5...............................................  Endometriosis of intestine.
780.71..............................................  Chronic fatigue syndrome.
780.79..............................................  Other malaise and fatigue.
783.0...............................................  Anorexia.
783.2...............................................  Abnormal loss of weight.
787.01-.03..........................................  Nausea and vomiting.
787.1...............................................  Heartburn.
787.2...............................................  Dysphagia.
787.7...............................................  Abnormal feces.
787.91..............................................  Diarrhea.
787.99..............................................  Other symptoms involving digestive system.
789.00-.09..........................................  Abdominal pain.
789.30-.39..........................................  Abdominal or pelvic swelling, mass, or lump.
789.40-.49..........................................  Abdominal rigidity.
789.5...............................................  Ascites.
789.60-.69..........................................  Abdominal tenderness.
790.92..............................................  Abnormal coagulation profile.
792.1...............................................  Nonspecific abnormal findings in stool contents.
793.6...............................................  Nonspecific abnormal findings on radiological and other
                                                       examination, abdominal area, including retroperitoneum.
794.8...............................................  Nonspecific abnormal results of function studies, liver.
863.0-.90...........................................  Injury to gastrointestinal tract.
864.00-.09..........................................  Injury to liver without mention of open wound into cavity.
864.11-.19..........................................  Injury to liver with open wound into cavity.
866.00-.03..........................................  Injury to kidney without mention of open wound into
                                                       cavity.
866.10-.13..........................................  Injury to kidney with open wound into cavity.
902.0 -.9...........................................  Injury to blood vessels of abdomen and pelvis.
926.11-.19..........................................  Crushing injury of trunk, other specified sites.
926.8...............................................  Crushing injury of trunk, multiple sites.
926.9...............................................  Crushing injury of trunk, unspecified site.
964.2...............................................  Poisoning by agents primarily affecting blood
                                                       constituents, anticoagulants.
995.2...............................................  Unspecified adverse effect of drug, medicinal, and
                                                       biological substance.
V10.00-.09..........................................  Personal history of malignant neoplasm, gastrointestinal
                                                       tract.
V12.00..............................................  Personal history of unspecified infectious and parasitic
                                                       disease.
V12.72..............................................  Personal history of colonic polyps.
V58.61..............................................  Long term (current) use of anticoagulants.
V58.69..............................................  Long term (current) use of other medications.
V67.51..............................................  Following treatment with high risk medication, not
                                                       elsewhere specified.
----------------------------------------------------------------------------------------------------------------


[[Page 13166]]

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 Act of 1988 (CLIA) 
certificate for the testing performed will result in denial of 
claims.
     Tests that require an 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 Category B IDE 
devices is left to contractor discretion. (See 60 FR 48425, Sept. 
19, 1995)

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.
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

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

Sources of Information

    Ahlquist, D.A., ``Approach to the patient with occult 
gastrointestinal bleeding,'' in Tadatake, Y. (ed.), Textbook of 
Gastroenterology (2nd ed.), 1995, J.B. Lippincott, pp. 699-717.
    Tietz, N.W. (ed.), Clinical guide to Laboratory Tests (3rd ed.), 
1995, pp.452-454.
    Schleisenger, M.H., Wall, S.D., et al., ``Part X. 
Gastrointestinal Diseases'' in Wyngaarden, J.B., and Smith, L.H. 
(eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, 
pp. 656-807.
    Harrison's Principles of Internal Medicine (14th ed.), 1998, 
McGraw Hill.
    Wallach, J., Interpretation of Diagnostic Tests, 1996, Little 
Brown and Co.
    Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, 
Springhouse Corporation.
    Sleisenger and Fordtrans's Gastrointestinal and Liver Disease 
(6th ed.), 1997, W.B. Saunders.

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

[[Page 13167]]

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.
[FR Doc. 00-4834 Filed 3-9-00; 8:45 am]
BILLING CODE 4210-01-P