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Proposed Rule

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

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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).

Start Further Info

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).

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

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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 § 410.32(a), or by a qualified nonphysician practitioner, as described in § 410.32(a)(3). Tests may be furnished by any of the entities listed in § 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. Start Printed 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: Start Printed 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 § 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 § 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 § 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 Start Printed Page 13085encourage 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 § 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. Start Printed 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 § 7300.5 of the Medicare Carriers Manual and § 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 § 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. Start Printed 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).Start Printed 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 § 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 § 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 § 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 § 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 § 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 Start Printed Page 13089payment 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 § 410.32, we are proposing to add a new paragraph (d)(3)(iii) to § 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 § 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 Start Printed Page 13090claims 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 § 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 Start Printed Page 13091receipt 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 § 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 § 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 § 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 Start Printed Page 13092regarding 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, § 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, § 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, § 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, § 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, § 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 Start Printed Page 13093Order (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 § 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 Start Printed Page 13094clinical 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.

Start List of Subjects

List of Subjects in Part 410

End List of Subjects

For the reasons set forth in the preamble, 42 CFR chapter IV would be amended as follows:

Start Part

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:

Start Authority

Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 2. In § 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:

End Authority
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.

Start Printed 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)

Start Signature

Dated: July 9, 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.

Dated: November 24, 1999.

Donna E. Shalala,

Secretary.

End Signature

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. Start Printed 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:
87086Culture, bacterial, urine; quantitative, colony count.
87087Culture, bacterial, urine; commercial kit.
87088Culture, bacterial, urine; identification, in addition to quantitative or commercial kit.
87184Sensitivity studies, antibiotic; disk method, per plate (12 or fewer disks).
87186Sensitivity 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

CodeDescriptor
003.1Salmonella septicemia.
038.0-038.9Septicemia.
276.2Acidosis.
276.4Metabolic acidosis/alkalosis.
286.6Defibrination syndrome/disseminated intravascular coagulation.
288.0Agranulocytosis/neutropenia.
288.8Other specified disease of white blood cells including leukemoid reaction/leukocytosis.
306.53Psychogenic dysuria.
306.59Other psychogenic genitourinary malfunction.
518.82Other pulmonary insufficiency, not elsewhere classified.
570Acute and subacute necrosis of liver.
Start Printed Page 13097
580.0-580.9Acute glomerulonephritis.
583.0-583.9Nephritis and Nephropathy, not specified as acute or chronic.
584.5Acute renal failure, with lesion of tubular necrosis.
584.9Acute renal failure, unspecified.
585Chronic renal failure.
586Renal failure, unspecified.
590.00-590.9Infections of kidney/pyelonephritis acute and chronic.
592.0-592.9Calculus of kidney and ureter.
593.0-593.9Other disorders of kidney and ureter (cyst, stricture, obstruction, reflux, etc.).
594.0-594.9Calculus of lower urinary tract.
595.0-595.9Cystitis.
597.0Urethritis, not sexually transmitted and urethral syndrome.
597.80-597.89Other urethritis.
598.00-598.01Urethral stricture due to infection.
599.0Urinary tract infection, site not specified.
599.7Hematuria.
600Hyperplasia of prostate.
601.0-601.9Inflammatory diseases of prostate.
602.0-602.9Other disorders of prostate (calculus, congestion, atrophy, etc.).
604.0-604.99Orchitis and epididymitis.
608.0-608.9Other disorders of male genital organs (seminal vesiculitis, spermatocele, etc.).
614.0-614.9Inflammatory disease of ovary, fallopian tube, pelvic cellular tissue, and peritoneum.
615.0-615.9Inflammatory disease of uterus, except cervix.
616.0Cervicitis and endocervicitis.
616.10-616.11Vaginitis and vulvovaginitis.
616.2-616.9Other inflammatory conditions of cervix, vagina and vulva.
619.0-619.9Fistula involving female genital tract.
625.6Stress incontinence, female.
639.0Genital tract and pelvic infection complicating abortion, ectopic or molar pregnancies.
639.5Shock complicating abortion, ectopic or molar pregnancies.
646.60-.64Infections of genitourinary tract in pregnancy.
670.00-.04Major puerperal infection.
672.00-.04Pyrexia of unknown origin during the puerperium.
724.5Backache, unspecified.
780.2Syncope and collapse.
780.6Fever (Hyperthermia).
780.79Other malaise and fatigue.
780.9Other general symptoms (altered mental status, chills, generalized pains).
785.0Tachycardia, unspecified.
785.50-.59Shock without mention of trauma.
788.0-788.9Symptoms 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).
789.00-789.09Abdominal pain.
789.60-789.69Abdominal tenderness.
790.7Bacteremia.
791.0-791.9Nonspecific 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).
799.3Debility, unspecified (only for declining functional status).
939.0Foreign body in genitourinary tract, bladder and urethra.
939.3Foreign body in genitourinary tract, penis.
V44.50-V44.6Artificial cystostomy or other artificial opening of urinary tract status.
V55.5-V55.6Attention to cystostomy or other artificial opening of urinary tract.
V58.69Long-term (current) use of other medications.
V72.84Pre-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 Start Printed Page 13098nonphysician 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..

CodeDescriptor
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13099though 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)

CodeDescriptor
87536Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification.
87539Infectious 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

CodeDescriptor
042Human immunodeficiency virus [HIV] disease.
079.53Human immunodeficiency virus, type 2 [HIV-2].
647.60-.64Other viral diseases complicating pregnancy (including HIV-I and II).
795.71Nonspecific serologic evidence of human immunodeficiency virus [HIV].
V08Asymptomatic human immunodeficiency virus [HIV] infection status.
Start Printed 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

CodeDescriptor
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
DV16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13101provided 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):

CodeDescriptor
86689Qualitative or semiquantitative immunoassays performed by multiple step methods; HTLV or HIV antibody, confirmatory test (for example, Western Blot).
86701Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1.
86702Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-2.
86703Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 and HIV-2, single assay.
87390Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step; HIV-1.
87391Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step; HIV-2.
87534Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique.
87535Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique HIV-1, amplified probe technique.
87537Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique.
87538Infectious 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, Start Printed Page 13102pancytopenia, 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

CodeDescription
003.1Salmonella septicemia.
007.2Coccidiosis (Isoporiasis).
007.4Cryptosporidiosis.
007.8Other specified protozoal intestinal diseases.
010.00-010.96Primary tuberculous infection.
011.00-011.96Pulmonary tuberculosis.
012.00-012.86Other respiratory tuberculosis.
013.00-013.96Tuberculosis of meninges and central nervous system.
014.00-014.86Tuberculosis of intestines, peritoneum and mesenteric glands.
015.00-015.96Tuberculosis of bones and joints.
016.00-016.96Tuberculosis of genitourinary system.
017.00-017.96Tuberculosis of other organs.
018.00-018.96Miliary tuberculosis.
027.0Listeriosis.
031.0-031.9Diseases due to other mycobacteria.
038.2Pneumococcal septicemia.
038.43Septicemia (Pseudomonas).
039.0-.9Actinomycotic infections (includes Nocardia).
041.7Pseudomonas infection.
042HIV disease (Acute retroviral syndrome, AIDS-related complex).
046.3Progressive multifocal leukoencephalopathy.
049.0-049.9Other non-arthropod-borne viral diseases of central nervous system.
052.0-052.8Chickenpox (with complication).
053.0-053.9Herpes zoster.
054.0-054.9Herpes simplex.
055.0-055.8Measles (with complication).
070.20-070.23Viral hepatitis B with hepatic coma.
070.30-070.33Viral hepatitis B without mention of hepatic coma.
070.41Acute or unspecified hepatitis C with hepatic coma.
070.42Hepatitis delta without mention of active hepatitis B disease with hepatic coma.
070.44Chronic hepatitis C with hepatic coma.
070.49Other specified viral hepatitis with hepatic coma.
070.51Acute or unspecified hepatitis C without hepatic coma.
070.52Hepatitis delta without mention of active hepatitis B disease without hepatic coma.
070.54Chronic hepatitis C without hepatic coma.
070.59Other specified viral hepatitis without hepatic coma.
070.6Unspecified viral hepatitis with hepatic coma.
070.9Unspecified viral hepatitis without hepatic coma.
078.0Molluscum contagiosum.
078.10-078.19Viral warts.
078.3Cat-scratch disease.
078.5Cytomegaloviral disease.
078.88Other specified diseases due to Chlamydiae.
079.50Retrovirus unspecified.
079.51HTLV-I.
079.52HTLV-II.
079.53HTLV-III.
079.59Other specified Retrovirus.
Start Printed Page 13103
079.88Other specified chlamydial infection.
079.98Unspecified chlamydial infection.
085.0-085.9Leishmaniasis.
088.0Bartonellosis.
090.0-090.9Congenital syphilis.
091.0-091.9Early syphilis symptomatic.
092.0-092.9Early syphilis, latent.
093.0-093.9Cardiovascular syphilis.
094.0-094.9Neurosyphilis.
095.0-095.9Other forms of late syphilis, with symptoms.
096Late syphilis, latent.
097.0-097.9Other and unspecified syphilis.
098.0-098.89Gonococcal infections.
099.0Chancroid.
099.1Lymphogranuloma venereum.
099.2Granuloma inguinale.
099.3Reiter's disease.
099.40-099.49Other nongonococcal urethritis.
099.50-099.59Other venereal diseases due to Chlamydia trachomatis.
099.8Other specified venereal disease.
099.9Venereal disease unspecified.
110.1Dermatophytosis of nail.
111.0Pityriasis versicolor.
112.0-112.9Candidiasis.
114.0-114.9Coccidioidomycosis.
115.00-115.99Histoplasmosis.
116.0-116.2Blastomycotic infection.
117.3Aspergillosis.
117.5Cryptococcosis.
118Opportunistic mycoses.
127.2Strongyloidiasis.
130.0-130.9Toxoplasmosis.
131.01Trichomonal vulvovaginitis.
132.2Phthirus pubis.
133.0Scabies.
136.2Specific infections by free living amebae.
136.3Pneumocystosis.
136.8Other specified infectious and parasitic disease (for example, microsporidiosis).
176.0-176.9Kaposi's sarcoma.
180.0-180.9Malignant neoplasm of cervix uteri.
200.20-200.28Burkitt's tumor or lymphoma.
200.80-200.88Lymphosarcoma, other named variants.
201.00-201.98Hodgkin's disease.
280.0-280.9Iron deficiency anemias.
285.9Anemia, unspecified.
287.3Primary thrombocytopenia.
288.0Agranulocytosis.
288.8Other specified disease of white blood cells.
294.8Other specified organic brain syndromes (chronic).
310.1Organic personality syndrome.
322.2Chronic meningitis.
336.9Unspecified disease of spinal cord.
348.3Encephalopathy unspecified.
354.0-354.9Mononeuritis of upper limbs and mononeuritis multiplex.
356.8Other specified idiopathic peripheral neuropathy.
363.20Chorioretinitis, unspecified.
425.4Other primary cardiomyopathies.
473.0-473.9Chronic sinusitis.
481Pneumococcal pneumonia.
482.0-482.9Other bacterial pneumonia.
484.1Pneumonia in cytomegalic inclusion disease.
512.8Other spontaneous pneumothorax.
516.8Other specified alveolar and parietoalveolar pneumonopathies.
528.2Oral aphthae.
528.6Leukoplakia of oral mucosa.
530.2Ulcer of esophagus.
583.9Nephropathy with unspecified pathological lesion in kidney.
588.8Other specified disorders resulting from impaired renal function.
647.60-.64Other viral diseases complicating pregnancy (use for HIV I and II).
682.0-682.9Other cellulitis and abscess.
690.10-690.18Seborrheic dermatitis.
696.1Other psoriasis.
698.3Lichenification and lichen simplex chronicus.
704.8Other specified diseases of hair and hair follicles.
Start Printed Page 13104
706.0-706.9Diseases of sebaceous glands.
780.6Fever.
780.79Other malaise and fatigue.
783.2Abnormal loss of weight.
783.4Lack of expected normal physiological development.
785.6Enlargement of lymph nodes.
786.00Respiratory abnormality, unspecified.
786.05Shortness of breath.
786.2Cough.
786.3Hemoptysis.
786.4Abnormal sputum.
787.91Diarrhea.
795.71Nonspecific serologic evidence of human immunodefiency virus.
799.4Wasting disease.
V01.7Contact with or exposure to communicable diseases, other viral diseases.
V71.5Rape.

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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
Start Printed Page 13105
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):

CodeDescriptor
85007Blood count; manual differential WBC count (includes RBC morphology and platelet estimation).
85008Blood counts, manual blood smear examination without differential parameters.
85013Blood counts, Spun microhematocrit.
85014Blood counts, Other than spun hematocrit.
85018Blood counts, Hemoglobin.
85021Blood counts, Hemogram, automated (RBC, WBC, Hgb, Hct, and indices only).
85022Blood counts, Hemogram, automated, and manual differential WBC count (CBC).
85023Blood counts, Hemogram and platelet count, automated, and manual differential WBC count (CBC).
85024Blood counts, Hemogram and platelet count, automated, and automated partial differential WBC count (CBC).
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85025Hemogram and platelet count, automated and automated complete differential WBC count (CBC).
85027Blood counts, Hemogram and platelet count, automated.
85031Blood count; hemogram, manual, complete CBC (RBC, Hgb, Hct, differential and indices.
85048Blood counts, White blood cell (WBC).
85590Platelet; manual count.
85595Platelet, 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 Start Printed Page 13107necessary 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

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

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

CodeDescription
078.10-078.19Viral warts.
210.0-210.9Benign neoplasm of lip, oral cavity, and pharynx.
214.0Lipoma, skin and subcutaneous tissue of face.
216.0-216.9Benign neoplasm of skin.
217Benign neoplasm of breast.
222.0-222.9Benign neoplasm of male genital organs.
224.0Benign neoplasm of eye.
230.0Carcinoma in situ of lip, oral cavity and pharynx.
232.0-232.9Carcinoma in situ of skin.
300.00-300.09Neurotic disorders.
301.0-301.9Personality disorders.
302.0-302.9Sexual deviations and disorders.
307.0Stammering and stuttering.
307.20-307.23Tics.
307.3Stereotyped repetitive movements.
307.80-307.89Psychalgia.
312.00-312.9Disturbance of conduct, not elsewhere classified.
313.0-313.9Disturbance of emotions specific to childhood and adolescence.
314.00-314.9Hyperkinetic syndrome of childhood.
363.30-363.35Chorioretinal scars.
363.40-363.43Choroidal degeneration.
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363.50-363.57Hereditary choroidal dystrophies.
363.70-363.9Choroidal detachment.
366.00-366.9Cataract.
367.0-367.9Disorders of refraction and accommodation.
371.00-371.9Corneal opacity and other disorders of cornea.
373.00-373.9Inflammation of eyelids.
375.00-375.9Disorders of lacrimal system.
376.21-376.9Disorders of the orbit, except 376.3 Other exophthalmic conditions.
377.10-377.16Optic atrophy.
377.21-377.24Other disorders of optic disc.
384.20-384.25Perforation of tympanic membrane.
384.81-384.82Other specified disorders of tympanic membrane.
385.00-385.90Other disorders of middle ear and mastoid.
387.0-387.9Otosclerosis.
388.00-388.5Other disorders of ear.
389.00-389.9Hearing loss.
440.0-440.1Atherosclerosis of aorta and renal artery.
443.8-443.9Peripheral vascular disease.
448.1Capillary nevus, non neoplastic.
457.0Postmastectomy lymphedema syndrome.
470Deviated nasal septum.
471.0-471.9Nasal polyps.
478.0Hypertrophy of nasal turbinates.
478.4Polyp of vocal cord or larynx.
520.0-520.9Disorders of tooth development and eruption.
521.0-521.9Diseases of hard tissues of teeth.
524.00-524.9Dentofacial anomalies, including malocclusion.
525.0-525.9Other diseases and conditions of teeth and supporting structures.
526.0-526.3Diseases of the jaws.
527.6-527.9Diseases of the salivary glands.
575.6Cholesterolosis of gallbladder.
600Hyperplasia of prostate.
603.0Encysted hydrocele.
603.8Other specified types of hydrocele.
603.9Hydrocele, unspecified.
605Redundant prepuce and phimosis.
606.0-606.1Infertility, male.
608.1Spermatocoele.
608.3Atrophy of testis.
610.0-610.9Benign mammary dysplasia.
611.1-611.6Other disorders of breast.
611.9Unspecified breast disorder.
616.2Cyst of Bartholin's gland.
618.0-618.9Genital prolapse.
620.0-620.3Noninflammatory disorders of ovary, fallopian tube, and broad ligament.
621.6-621.7Malposition or inversion of uterus.
627.2-627.9Menopausal and post menopausal disorders.
628.0-628.9Infertility, female.
676.00-676.94Other disorders of breast associated with childbirth and disorders of lactation.
691.0-691.8Atopic dermatitis and related disorders.
692.0-692.9Contact dermatitis and other eczema.
700Corns and callosities.
701.0-701.9Other hypertrophic and atrophic conditions of skin.
702.0-702.8Other dermatoses.
703.9Unspecified disease of nail.
706.0-706.9Diseases of sebaceous glands.
709.00-709.4Other disorders of skin and subcutaneous tissue.
715.00-715.98Osteoarthrosis.
716.00-716.99Other and unspecified arthropathies.
718.00-718.99Other derangement of joint.
726.0-726.91Peripheral esthesiopathies and allied syndromes.
727.00-727.9Other disorders of synovium, tendon, and bursa.
728.10-728.85Disorders of muscle ligament and fascia.
732.0-732.9Osteochondropathies.
733.00-733.09Osteoporosis.
734Flat foot.
735.0-735.9Acquired deformities of toe.
736.00-736.9Other acquired deformities of limb.
737.0-737.9Curvature of spine.
738.0-738.9Other acquired deformity.
739.0-739.9Nonallopathic lesions, not elsewhere classified.
830.0-839.9Dislocations.
840.0-848.9Sprains and strains.
905.0-909.9Late effects of musculoskeletal and connective tissue injuries.
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910.0-919.9Superficial injuries.
930.0-932Foreign body on external eye, in ear, in nose.
955.0-957.9Injury to peripheral nerve.
V03.0-V06.9Need for prophylactic vaccination.
V11.0-V11.9Personal history of mental disorder.
V14.0-V14.8Personal history of allergy to medicinal agents.
V16.0Family history of malignant neoplasm, gastrointestinal tract.
V16.3Family history of malignant neoplasm, breast.
V21.0-V21.9Constitutional states in development.
V25.01-V25.9Encounter for contraceptive management.
V26.0-V26.9Procreative management.
V40.0-V40.9Mental and behavioral problems.
V41.0-V41.9Problems with special senses and other special functions.
V43.0-V43.1Organ or tissue replaced by other means, eye globe or lens.
V44.0-V44.9Artificial opening status.
V45.00-V45.89Other post surgical states.
V48.0-V48.9Problems with head, neck, and trunk.
V49.0-V49.9Problems with limbs.
V51Aftercare involving the use of plastic surgery.
V52.0-V52.9Fitting and adjustment of prosthetic device and implant.
V53.01-V53.09Fitting and adjustment of devices related to nervous system and special senses.
V53.1Fitting and adjustment of spectacles and contact lenses.
V53.31-V53.39Fitting and adjustment of cardiac device.
V53.4Fitting and adjustment of orthodontic devices.
V53.5Fitting and adjustment of other intestinal appliance.
V53.6Fitting and adjustment of urinary devices.
V53.7Fitting and adjustment of orthopedic devices.
V53.8Fitting and adjustment of wheelchair.
V53.9Fitting and adjustment of other and unspecified device.
V54.0-V54.9Other orthopedic aftercare.
V55.0-V55.9Attention to artificial openings.
V57.0-V57.9Care involving use of rehabilitation procedures.
V58.5Orthodontics.
V59.0-V59.9Donors.
V61.0-V61.9Other family circumstances.
V62.2-V62.9Other psychosocial circumstances.
V65.2Person feigning illness.
V65.3Dietary surveillance and counseling.
V65.40-V65.49Other counseling, not elsewhere classified.
V65.5Person with feared complaint in whom no diagnosis was made.
V65.8Other reasons for seeking consultation.
V65.9Unspecified reason for consultation.
V66.0-V66.9Convalescence and palliative care.
V67.3Follow-up examination following psychotherapy.
V67.4Follow-up examination following treatment of healed fracture.
V69.3Problems related to lifestyle, gambling and betting.
V71.01-V71.09Observation and evaluation for suspected conditions not found, mental.
V72.0-V72.2Special investigations, examination of eyes and vision, ears and hearing, dental.
V72.4-V72.7Special investigations, radiologic exam, laboratory exam, diagnostic skin and sensitization tests.
V72.9Special investigation, unspecified.
V76.10-V76.19Special screening for malignant neoplasms, breast.
V76.2Special 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 Start Printed Page 13110Clinic 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):

CodeDescriptor
85730Thromboplastin 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

CodeDescription
002.0-002.9Typhoid and paratyphoid.
003.0-003.9Other Salmonella infections.
042Human immunodeficiency virus (HIV) disease.
038.9Unspecified Septicemia.
060.0-060.9Yellow fever.
65.0-065.9Arthopod borne hemorrhagic fever.
070.0-070.9Viral Hepatitis.
075Infectious mononucleosis.
078.6Hemorrhagic nephrosonephritis.
078.7Arenaviral hemorrhagic fever.
120.0Schistosomiasis haematobium.
121.1Clonorchiasis.
121.3Fascioliasis.
124Trichinosis.
135Sarcoidosis.
155.0-155.2Malignant neoplasm of liver and intrahepatic bile ducts.
197.7Malignant neoplasm of liver, specified as secondary.
238.4Polycythemia vera.
238.7Other lymphatic and hemapoietic tissues.
239.9Neoplasm of unspecified nature, site unspecified.
246.3Hemorrhage and infarction of thyroid.
250.40-250.43Diabetic with renal manifestations.
269.0Deficiency of Vitamin K.
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273.0-273.9Disorders of plasma protein metabolism.
273.2Other paraproteinemias.
275.0-275.9Disorders of iron metabolism.
277.1Disorders of porphyrin metabolism.
277.3Amyloidosis.
285.1Acute posthemorrhagic anemia.
286.0Congenital factor VIII disorder—Hemophilia A.
286.1Congenital factor IX disorder—Hemophilia B.
286.2-286.3Other congenital factor deficiencies.
286.4von Willebrand's disease.
286.5Hemorrhagic disorder due to circulating anticoagulants.
286.6Defibrination syndrome.
286.7Acquired coagulation factor deficiency.
286.8-.9Other and unspecified coagulation defects.
287.0-287.9Purpura and other hemorrhagic conditions.
289.0Polycythemia, secondary.
325Phlebitis and thrombophlebitis of intracranial ventricles sinuses.
360.43Hemophthalmos, except current injury.
362.34Amaurosis fugax.
362.43Hemorrhagic detachment of retinal pigment epithelium.
362.81Retinal hemorrhage.
363.6Choroidal hemorrhage.
363.72Choroidal detachment.
368.9Unspecified Visual Disturbances.
372.72Conjunctive hemorrhage.
374.81Hemorrhage of eyelid.
376.32Orbital hemorrhage.
377.42Hemorrhage in optic nerve sheaths.
379.23Vitreous hemorrhage.
380.31Hematoma of auricle or pinna.
403.01, 403.11, 403.91Hypertensive Renal Disease with renal failure.
404.02, 404.12, 404.92Hypertensive Heart and Renal Disease with renal failure.
423.0Hemopericardium.
427.31Atrial fibrillation.
427.9Cardiac dysrhythmias, unspecified.
428.0Congestive heart failure.
429.79Mural thrombus.
430-432.9Cerebral hemorrhage.
433.00-433.91Occlusion and stenosis of precerebral arteries.
434.00-434.91Occlusion of cerebral arteries.
435.9Focal neurologic deficit.
444.0-444.9Arterial embolism and thrombosis.
446.6Thrombotic microangiopathy.
447.2Rupture of artery.
448.0Hereditary Hemorrhagic telangiectasia.
451.0-451.9Phlebitis and thrombophlebitis.
453.0-453.9Other Venous emboli and thrombosis.
456.0Esophageal varices with bleeding.
456.1Esophageal varices without bleeding.
459.89Ecchymosis.
530.7Gastroesophageal laceration—hemorrhage syndrome.
531.00-535.61Gastric-Duodenal ulcer disease.
537.83Angiodysplasia of stomach and duodenum with hemorrhage.
556.0-557.9Hemorrhagic bowel disease.
562.02-562.03Diverticulosis of small intestine with hemorrhage.
562.12Diverticulosis of colon with hemorrhage.
562.13Diverticulitis of colon without hemorrhage.
568.81Hemoperitoneum (nontraumatic).
569.3Hemorrhage of rectum and anus.
570Acute and subacute necrosis of liver.
571.0-573.9Liver disease (in place of specific codes listed).
576.0-576.9Biliary tract disorders.
577.0Acute pancreatitis.
578.0-578.9Gastrointestinal Hemorrhage.
579.0-579.9Malabsorption.
581.0-581.9Nephrotic Syndrome.
583.9Nephritis, with unspecified pathological lesion in kidney.
584.5-584.9Acute Renal Failure.
585Chronic Renal Failure.
586Renal failure.
593.81-593.89Other disorders of kidney and ureter, with hemorrhage.
596.7Hemorrhage into bladder wall.
596.8Other disorders of bladder, with hemorrhage.
599.7Hematuria.
Start Printed Page 13112
607.82Penile hemorrhage.
608.83Vascular disorders of male genital organs.
611.8Hematoma of breast.
620.7Hemorrhage of broad ligament.
621.4Hematometra.
622.8Other specified disorders of cervix, with hemorrhage.
623.6Vaginal hematoma.
623.8Other specified diseases of the vagina, with hemorrhage.
624.5Hematoma of vulva.
626.6Metrorrhagia.
626.7Postcoital bleeding.
627.0Premenopausal bleeding.
627.1Postmenopausal bleeding.
629.0Hematocele female not elsewhere classified.
632Missed abortion.
634.00-634.92Spontaneous abortion.
635.10-635.12Legally induced abortion, complicated by delayed or excessive hemorrhage.
636.10-636.12Illegally induced abortion, complicated by delayed or excessive hemorrhage.
637.10-637.12Abortion unspecified, complicated by delayed or excessive hemorrhage.
638.1Failed attempt abortion, complicated by delayed or excessive hemorrhage.
639.1Delayed or excessive hemorrhage following abortion and ectopic and molar pregnancies.
639.6Complications following abortion and ectopic and molar pregnancies, embolism.
640.00-640.93Hemorrhage in early pregnancy.
641.00-641.93Antepartum hemorrhage.
642.00-642.94Hypertension complicating pregnancy, childbirth, and the puerperium.
646.70-646.73Liver disorders in pregnancy.
656.00-656.03Fetal maternal hemorrhage.
658.40-658.43Infection of amniotic cavity.
666.00-666.34Postpartum hemorrhage.
671.20-671.54Phlebitis in pregnancy.
673.00-673.84Obstetrical pulmonary embolus.
674.30-674.34Other complications of surgical wounds, with hemorrhage.
710.0Systemic Lupus erythematosus.
713.2Arthropathy associated with hematologic disorders (note: may not be used without indicating associated condition first).
713.6Arthropathy associated with Henoch Schoenlein (note: may not be used without indicating associated condition first).
719.10-.19Hemarthrosis.
729.5Leg pain/calf pain.
733.1Pathologic fracture associated with fat embolism.
762.1Other forms of placental separation with hemorrhage (affecting newborn code—do not assign to mother's record).
764.90-764.99Fetal intrauterine growth retardation.
767.0-767.1Subdural and cerebral hemorrhage.
767.8Other specified birth trauma, with hemorrhage.
770.3Fetal and newborn pulmonary hemorrhage.
772.0-.9Fetal and neonatal hemorrhage.
774.0-.7Other perinatal jaundice.
776.0-776.9Hemorrhagic disease of the newborn.
780.2Syncope.
782.4Jaundice, unspecified, not of newborn.
782.7Spontaneous ecchymoses Petechiae.
784.7Epistaxis.
784.8Hemorrhage from throat.
785.4Gangrene.
785.50Shock.
786.05Shortness of breath.
786.3Hemoptysis.
786.59Chest pain.
789.00-.09Abdominal pain.
790.92Abnormal coagulation profile.
800.00-800.99Fracture of vault of skull.
801.00-801.99Fracture of base of skull.
802.20-802.9Fracture of face bones.
803.00-.99Other fracture, skull.
804.00-.99Multiple fractures, skull.
805.00-806.9Fracture, vertebral column.
807.00-807.09Fractures of rib(s), closed.
807.10-807.19Fracture of rib(s), open.
808.8-.9Fracture of pelvis.
809.0-.1Fracture of trunk.
810.00-.13Fracture of clavicle.
811.00-.19Fracture of scapula.
812.00-.59Fracture of humerus.
813.10-.18Fracture of radius and ulna, upper end, open.
Start Printed Page 13113
813.30-.38Fracture of radius and ulna, shaft, open.
813.50-813.58Fracture of radius and ulna, lower end, open.
813.90-.98Fracture of radius and ulna, unspecified part, open
819.0-819.1Multiple fractures.
820.00- 821.39Femur.
823.00-.92Tibia and fibula.
827.0-829.1Other multiple lower limb.
852.00-853.19Subarachnoid subdural, and extradural hemorrhage, following injury, Other and specified intracranial hemorrhage following injury.
860.0-860.5Traumatic pneumothorax and hemothorax.
861.00-.32Injury to heart and lung.
862.0-.862.9Injury to other and unspecified intrathoracic organs.
863.0-.9Injury to gastrointestinal tract.
864.00-.19Injury to liver.
865.00-.19Injury to spleen.
866.00-.13Injury to kidney.
867.0-.9Injury to pelvic organs.
868.00-.19Injury to other intra-abdominal organs.
869.0-.1Internal injury to unspecified or ill defined organs.
900.00-.9Injury to blood vessels of head and neck.
901.0-.9Injury to blood vessels of the thorax.
902.0-.9Injury to blood vessels of the abdomen and pelvis.
903.00-.9Injury to blood vessels of upper extremity.
904.0-.9Injury to blood vessels of lower extremity and unspecified sites.
920-924.9Contusion with intact skin surface.
925.1-929.9Crushing injury.
958.2Secondary and recurrent hemorrhage.
959.9Injury, unspecified site.
964.2Poisoning by anticoagulants.
964.5Poisoning by anticoagulant antagonists.
964.7Poisoning by natural blood and blood products.
980.0Toxic effects of alcohol.
989.5Snake venom.
995.2Unspecified adverse effect of drug, medicinal and biological substance (due to correct medicinal substance properly administered).
996.7Other complications of internal prosthetic device.
997.02Iatrogenic cerbrovascular infarction or hemorrhage.
998.11Hemorrhage or hematoma complicating a procedure.
999.2Other vascular complications of medical care.
V12.3Personal history of diseases of blood and blood forming organs.
V58.2Admission for Transfusion of blood products.
V58.61Long term (current use) of anticoagulants.
V72.81Pre-operative cardiovascular examination.
V72.83Other specified pre-operative examination.
V72.84Pre-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 DeniedStart Printed Page 13114

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

CodeDescriptor
85610Prothrombin 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

CodeDescription
002.0-002.9Typhoid and paratyphoid.
003.0-003.9Other Salmonella infections.
038.9Unspecified Septicemia.
042Human Immunodeficiency virus (HIV) disease.
060.0-060.9Yellow fever
065.0-065.9Arthropod-borne hemorrhagic fever.
070.0-070.9Viral hepatitis.
075Infectious mononucleosis.
078.6Hemorrhagic nephrosonephritis.
078.7Arenaviral hemorrhagic fever.
84.8Blackwater fever.
120.0Schistosomiasis.
121.1Clonorchiasos.
121.3Fascioliasis.
Start Printed Page 13116
124Trichinosis.
134.2Hirudiniasis.
135Sarcoidosis.
152.0-152.9Malignant neoplasm of small intestine, including duodenum.
155.0-155.2Malignant neoplasm of liver and intrahepatic bile ducts.
156.0-156.9Malignant neoplasm of gallbladder and extrahepatic bile ducts.
157.0-157.9Malignant neoplasm of pancreas.
188.0-189.9Malignant neoplasm of bladder, kidney, and other and unspecified urinary organs.
198.0Secondary malignant neoplasm, kidney.
198.1Secondary malignant neoplasm, other urinary organs.
200.00-200.88Lymphosarcoma and reticulosarcoma.
202.0-202.98Nodular and other Lymphomas.
223.0-223.9Benign neoplasm of kidney and other urinary organs.
238.4Polycythemia vera.
238.5Histocytic and mast cells—neoplasm of uncertain behavior.
238.6Plasma cells—neoplasm of uncertain behavior.
238.7Other lymphatic and hematopoietic tissues.
239.4Neoplasm of unspecified nature, bladder.
239.5Neoplasm of unspecified nature, other genitourinary organs.
239.9Neoplasm of unspecified nature, site unspecified.
246.3Hemorrhage and infarction of thyroid.
250.40-250.43Diabetic with renal manifestations.
263.0-263.9Other and unspecified protein/calorie malnutrition.
269.0Deficiency of Vitamin K.
269.2.Unspecified vitamin deficiency.
273.0-273.9Disorders of plasma protein metabolism.
275.0Disorders of iron metabolism.
277.1Disorders of porphyrin metabolism.
277.3Amyloidosis.
280.0Iron deficiency anemia, secondary to blood loss—chronic.
280.9Iron deficiency anemia, unspecified.
281.0Pernicious anemia.
281.1Other Vitamin B12 Deficiency Anemia, NEC.
281.9Unspecified Deficiency Anemia, NOS.
285.0Sideroblastic anemia.
285.1Acute posthemorrhagic anemia.
286.0- 286.9Coagulation defects.
287.0-287.9Purpura and other hemorrhagic conditions.
290.40-290.43Arteriosclerotic dementia.
325Phlebitis and thrombophlebitis of intracranial venous sinuses.
342.9Hemiplegia NOS.
42.90Hemiplegia NOS, Side NEC.
360.43Hemophthalmios, except current injury.
362.18Retinal vasculitis.
362.30-362.37Retinal vascular occlusion.
362.43Hemorrhagic detachment of retnal pigment epithelium.
362.81Retinal hemorrhage.
363.61-363.72Choroidal hemorrhage and rupture, detachment.
368.9Unspecified Visual Disturbances.
372.72Conjunctival hemorrhage.
374.81Hemorrage in optic nerve sheaths.
376.32Orbital hemorrhage.
377.42Hemorrhage in optic nerve sheaths.
377.53Disorders of optic chiasm associated with vascular disorders.
377.62Disorders of visual pathways associated with vascular disorders.
377.72Disorders of visual cortex associated with vascular disorders.
379.23Vitreous hemorrhage.
380.31Hematoma of auricle or pinna.
386.2Vertigo of central origin.
386.50Labyrinthine dysfunction, unspecified.
394.0-394.9Diseases of the mitral valve.
395.0Rheumatic aortic stenosis.
395.2Rheumatic aortic stenosis with insufficiency.
396.0-396.9Diseases of mitral and aortic valves.
397.0-397.9Diseases of other endocardial structures.
398.0-398.99Other rheumatic heart disease.
403.01, 403.11,
403.91Hypertensive Renal Disease with renal failure.
404.02, 404.12,
404.92Hypertensive Heart and Renal Disease with renal failure.
410.00-410.92Acute myocardial infarction.
411.1Intermediate coronary syndrome.
411.81Coronary occlusion without myocardial infarction.
411.89Other acute and subacute forms of ischemic heart disease.
Start Printed Page 13117
413.0-413.9Angina pectoris.
414.00-414.05Coronary atherosclerosis.
414.8Other specified forms of chronic ischemic heart disease.
414.9Chronic ischemic heart disease, unspecified.
415.0-415.19Acute pulmonary heart disease.
416.9Chronic pulmonary heart disease, unspecified.
423.0Hemopericardium.
424.0Mitral valve disorders.
424.1Aortic valve disorder.
424.90Endocarditis, valve unspecified, unspecified cause.
425.0-425.9Cardiomyopathy.
427.0-427.9Cardiac dysrhythmias.
428.0-428.9Heart failure.
429.0-429.4Ill-defined descriptions and complications of heart disease.
429.79Other certain sequelae of myocardial infarction, not elsewhere classified.
430Subarachnoid hemorrhage.
431Intracerebral hemorrhage.
432.0-432.9Other and unspecified intracranial hemorrhage.
433.00-433.91Occlusion and stenosis of precerebral arteries.
434.00-434.91Occlusion of cerebral arteries.
435.0-435.9Transient cerebral ischemia.
436Acute, but ill-defined cerebrovascular disease.
437.0Cerebral atherosclerosis.
437.1Other generalized ischemic cerebrovascular disease.
437.6Nonpyogenic thrombosis of intracranial venous sinus.
440.0-440.9Atherosclerosis.
441.0-441.9Aortic aneurysm and dissection.
443.0-443.9Other peripheral vascular disease.
444.0-444.9Arterial embolism and thrombosis.
447.1Stricture of artery.
447.2Rupture of artery.
447.6Arteritis, unspecified.
448.0Hereditary hemorrhagic telangiectasia.
448.9Other and unspecified capillary diseases.
451.0-451.9Phlebitis and thrombophlebitis.
452Portal vein thrombosis.
453.0-453.9Other venous embolism and thrombosis.
455.2Internal hemorrhoids with other complication.
455.5External hemorrhoids with other complication.
455.8Unspecified hemorrhoids with other complication.
456.0-456.1Esophageal varices.
456.8Varices of other sites.
459.0Hemorrhage, unspecified.
459.1Postphlebitis syndrome.
459.2Compression of vein.
459.81Venous (peripheral) insufficiency, unspecified.
459.89Other, other specified disorders of circulatory system.
511.8Other specified forms of effusion, except tuberculosis.
514Pulmonary congestion and hypostasis.
530.7Gastroesophageal laceration—hemorrhage syndrome.
530.82Esophageal hemorrhage.
531.00-535.61Gastric ulcer, duodenal ulcer, peptic ulcer, gastrojejunal ulcer, gastritis and duodenitis.
555.0-555.9Regional enteritis.
556.0-556.9Ulcerative colitis.
557.0-557.9Vascular insufficiency of intestine.
562.02—562.03Diverticulosis of small intestine with hemorrhage.
562.10Diverticulosis of colon w/o hemorrhage.
562.11Diverticulitis of colon w/o hemorrhage.
562.12Diverticulosis of colon with hemorrhage.
562.13Diverticulitis of colon without hemorrhage.
568.81Hemoperitoneum (nontraumatic).
569.3Hemorrhage of rectum and anus.
571.0-571.9Chronic liver disease and cirrhosis.
572.2Hepatic coma.
572.4Hepatorenal syndrome.
572.8Other sequelae of chronic liver disease.
573.1-573.9Hepatitis in viral diseases, other and unspecified disorder of liver.
576.0-576.9Other disorders of Biliary tract.
577.0Acute pancreatitis.
578.0-578.9Gastrointestinal hemorrhage.
579.0-579.9Intestinal Malabsorption.
581.0—581.9Nephrotic Syndrome.
583.9Nephritis, with unspecified pathological lesion in kidney.
584.5-584.9Acute Renal Failure.
Start Printed Page 13118
585Chronic Renal Failure.
586Renal failure, unspecified.
593.81-593.89Other specified disorders of kidney and ureter.
596.7Hemorrhage into bladder wall.
596.8Other specified disorders of bladder.
599.7Hematuria.
607.82Vascular disorders of penis.
608.83Vascular disorders of male genital organs.
611.8Other specified disorders of breast—hematoma.
620.7Hemorrhage of broad ligament.
621.4Hematometra.
622.8Other specified noninflammatory disorders of cervix.
623.6Vaginal hematoma.
623.8Other specified noninflammatory disorders of the vagina.
624.5Hematoma of vulva.
626.2-626.9Abnormal bleeding from female genital tract.
627.0Premenopausal menorrhagia.
627.1Postmenopausal bleeding.
629.0Hematocele female, not classified elsewhere.
632Missed abortion.
634.10-634.12Spontaneous abortion, complicated by excessive hemorrhage.
635.10-635.12Legally induced abortion, complicated by delayed or excessive hemorrhage.
636.10-636.12Illegally induced abortion, complicated by delayed or excessive hemorrhage.
637.10-637.12Abortion unspecified, complicated by delayed or excessive hemorrhage.
638.1Failed attempted abortion, complicated by delayed or excessive hemorrhage.
639.1Delayed or excessive hemorrhage following abortion and ectopic and molar pregnancies.
639.6Complications following abortion and ectopic and molar pregnancies with embolism.
640.00-640.93Hemorrhage in early pregnancy.
641.00-641.93Antepartum hemorrhage, abruptio placentae, and placenta previa.
642.00-642.94Hypertension complicating pregnancy, childbirth, and the puerperium.
646.70-646.73Liver disorders in pregnancy.
656.00-656.03Fetal maternal hemorrhage.
658.40-658.43Infection of amniotic cavity.
666.00-666.34Postpartum hemorrhage.
671.20-671.94Venous complications in pregnancy and the puerperium.
673.00-673.84Obstetrical pulmonary embolism.
674.30-674.34Other complications of obstetrical surgical wounds.
713.2Arthropathy associated with hematological disorders.
713.6Arthropathy associated with hypersensitivity reaction.
719.15Hemarthrosis (5th digits 5, 6, and 9 allowed only).
719.16Lower leg.
719.19Multiple sites.
729.5Pain in limb.
733.1Patholgic fracture, unspecified site.
746.00-746.9Other Congenital anomalies of heart.
762.1Other forms of placental separation and hemorrhage.
767.0-767.1Subdural and cerebral hemorrhage.
767.8Other specified birth trauma.
770.3Pulmonary hemorrhage.
772.0-772.9Fetal and neonatal hemorrhage.
774.6Unspecified fetal and neonatal jaundice.
776.0-776.9Hemorrhagic disease of the newborn.
780.2Syncope an collapse.
782.3Edema.
782.4Jaundice, unspecified, not of newborn.
782.7Spontaneous ecchymosis.
784.7Epistaxis.
784.8Hemorrhage from throat.
785.4Gangrene.
785.50Shock without mention of trauma.
786.05Shortness of breath.
786.3Hemoptysis.
786.59Chest pain, other.
789.00-789.09Abdominal pain.
789.1Hepatomegaly.
789.5Ascites.
790.92Abnormal coagulation profile.
790.94Euthyroid sick syndrome.
791.2Hemoglobinuria.
794.8Abnormal Liver Function Study.
800.00-800.99Fracture of vault of skull.
801.00-801.99Fracture of base of skull.
802.20-802.9Fracture of face bones.
803.00-803.99Other and unqualified skull fractures.
Start Printed Page 13119
804.00-804.99Multiple fractures involving skull or face with other bones.
805.00-806.9Fracture, vertebral column.
807.00-807.09Fractures of rib(s), closed.
807.10-807.19Fracture of rib(s), open.
808.8-808.9Fracture of Pelvis.
809.0-809.1Ill-defined fractures of bones of Trunk.
810.00-810.13Fracture of Clavicle.
811.00-811.19Fracture of Scapula.
812.00-812.59Fracture of Humerus.
813.10-18Fracture of radius and ulna, upper end, open.
813.30-38Shaft, open.
813.50-813.58Lower end, open.
813.90-98Fracture unspecified part, open.
819.0-819.1Multiple fractures involving both upper limbs, closed and open.
820.00-821.39Fracture of neck of femur.
823.00-823.92Fracture of tibia and fibula.
827.0-829.1Other multiple lower limb.
852.00-852.59Subarachnoid, subdural, and extradural hemorrhage, following injury.
853.00-853.19Other and specified intracranial hemorrhage following injury.
852.00-853.19Subarachnoid subdural, and extradural hemorrhage, following injury, Other and specified intracranial hemorrhage following injury.
860.0-860.5Traumatic pneumothorax and hemothorax.
861.00-.32Injury to heart and lung.
862.0-.862.9Injury to other and unspecified intrathoracic organs.
863.0-.9Injury to gastrointestinal tract.
864.00-.19Injury to liver.
865.00-.19Injury to spleen.
866.00-.13Injury to kidney.
867.0-.9Injury to pelvic organs.
868.00-.19Injury to other intra-abdominal organs.
869.0-.1Internal injury to unspecified or ill defined organs.
900.00-.9Injury to blood vessels of head and neck.
901.0-.9Injury to blood vessels of the thorax.
902.0-.9Injury to blood vessels of the abdomen and pelvis.
903.00-.9Injury to blood vessels of upper extremity.
904.0-.9Injury to blood vessels of lower extremity and unspecified sites.
920—924.9Contusion with intact skin surface.
925.1—929.9Crushing injury.
958.2Secondary and recurrent hemorrhage.
959.9Injury, unspecified site.
964.0-964.9Poisoning by agents primarily affecting blood constituents.
980.0-980.9Toxic effect of alcohol.
981Toxic effect of petroleum products.
982.0-982.8Toxic effects of solvents other than petroleum-based.
987.0-987.9Toxic effect of other gases, fumes or vapors.
989.0-989.9Toxic effect of other substances chiefly non-medicinal as to source.
995.2Unspecified adverse effect of drug, medicinal and biological substance (due to correct medicinal substance properly administered).
996.82Complication of transplanted liver.
997.4Digestive system complications.
998.11-998.12Hemorrhage or hematoma complicating a procedure.
997.02Iatrogenic cerbrovascular infarction or hemorrhage.
999.2Other vascular complications.
999.8Other transfusion reactions.
V08Asymptomatic HIV infection.
V12.1History of nutritional deficiency.
V12.3Personal history of diseases of blood and blood-forming organs.
V15.1Personal history of surgery to heart and great vessels.
V15.2Personal history of surgery of other major organs.
V42.0Kidney replaced by transplant.
V42.1Heart replaced by transplant.
V42.2Heart valve replaced by transplant.
V42.6Lung replaced by transplant.
V42.7Liver replaced by transplant.
V42.8Other specified organ or tissue replaced by transplant.
V43.2Heart replaced by other means.
V43.3Heart valve replaced by other means.
V43.4Blood vessel replaced by other means.
V43.60Unspecified joint replaced by other means.
V58.2Transfusion of blood products.
V58.61Long-term (current) use of anticoagulants.
V72.84Pre-operative examination, unspecified.
Start Printed 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

CodeDescription
798.0—798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13121Caveats”. 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):

CodeDescriptor
82728Ferritin.
83540Iron.
83550Iron Binding capacity.
84466Transferrin.

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 Start Printed 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

CodeDescription
002.0-002.9Typhoid and paratyphoid fevers.
003.0-003.9Other salmonella infections.
006.0-006.9Amebiasis.
007.0-007.9Other protozoal intestinal diseases.
008.00-008.8Intestinal infections due to other organisms.
009.0-009.3Ill-defined intestinal infections.
011.50-011.56Tuberculous bronchiectasis.
014.00-014.86Tuberculosis of intestines, peritoneum, and mesenteric glands.
015.00-015.96Tuberculosis of bones and joints.
016.00-016.06Tuberculosis of kidney.
016.10-016.16Tuberculosis of bladder.
016.20-016.26Tuberculosis of ureter.
016.30-016.36Tuberculosis of other urinary organs.
042Human Immunodeficiency virus (HIV) disease.
070.0-070.9Viral hepatitis.
140.0-149.9Malignant neoplasm of lip oral cavity and pharynx.
150.0-159.9Malignant neoplasm of digestive organs and peritoneum.
160.0-165.9Malignant neoplasm of respiratory and intrathoracic organs.
170.0-176.9Malignant neoplasm of bone, connective tissue, skin and breast.
179-189.9Malignant neoplasm of genitourinary organs.
190.0-199.1Malignant neoplasm of other and unspecified sites.
200.0-208.91Malignant neoplasm of lymphatic and hematopoietic tissue.
210.0-229.9Benign neoplasms.
230.0-234.9Carcinoma in situ.
235.0-238.9Neoplasms of uncertain behavior.
239.0-239.9Neoplasms of unspecified nature.
250.00-250.93Diabetes mellitus.
253.2Panhypopituitarism.
253.7Iatrogenic pituitary disorders.
253.8Other disorders of the pituitary and other syndromes of diencephalohypophyseal origin.
256.3Other ovarian failure.
257.2Other testicular hypofunction.
260Kwashiorkor.
261Nutritional marasmus.
262Other severe protein-calorie malnutrition.
263.0-263.9Other and unspecified protein-calorie malnutrition.
275.0Disorders of iron metabolism.
277.1Disorders of porphyrin metabolism.
280.0-280.9Iron deficiency anemias.
281.0-281.9Other deficiency anemias.
282.4Thalassemias.
285.0Sideroblastic anemia (includes hemochromatosis with refractory anemia).
285.1Acute post-hemorrhagic anemia.
Start Printed Page 13123
285.9Anemia, unspecified.
286.0-286.9Coagulation defects (congenital factor disorders).
287.0-287.9Purpura and other hemorrhagic conditions.
306.4Physiological malfunction arising from mental factors, gastrointestinal.
307.1Anexoria nervosa.
307.50-307.59Other and unspecified disorders of eating.
425.4Other primary cardiomyopathies.
425.5Alcoholic cardiomyopathy.
425.7Nutritional and metabolic cardiomyopathy.
425.8Cardiomyopathy in other diseases classified elsewhere.
425.9Secondary cardiomyopathy, unspecified.
426.0-426.9Conduction disorders.
427.0-427.9Cardiac dysrhythmias.
428.0-428.9Heart Failure.
530.7Gastroesophageal laceration-hemorrhage syndrome.
530.82Esophageal hemorrhage.
531.00-531.91Gastric ulcer.
532.00-532.91Duodenal ulcer.
533.00-533.91Peptic ulcer, site unspecified.
534.00-534.91Gastrojejunal ulcer.
535.00-535.61Gastritis and duodenitis.
536.0-536.9Disorders of function of stomach.
537.83Angiodysplasia of stomach and duodenum with hemorrhage.
555.0-555.9Regional enteritis.
556.0-556.9Ulcerative colitis.
557.0Acute vascular insufficiency of intestine.
557.1Chronic vascular insufficiency of intestine.
562.02Diverticulosis of small intestine with hemorrhage.
562.03Diverticulitis of small intestine with hemorrhage.
562.12Diverticulosis of colon with hemorrhage.
562.13Diverticulitis of colon with hemorrhage.
569.3Hemorrhage of rectum and anus.
569.85Angiodysplasia of intestine with hemorrhage.
570Acute and subacute necrosis of liver.
571.0-571.9Chronic liver disease and cirrhosis.
572.0-572.8Liver abscess and sequelae of chronic liver disease.
573.0-573.9Other disorders of liver.
578.0-578.9Gastrointestinal hemorrhage.
579.0-579.3Intestinal malabsorption.
581.0-581.9Nephrotic syndrome.
585Chronic renal failure.
586Renal failure, unspecified.
608.3Atrophy of testis.
626.0-626.9Disorders of menstruation and other abnormal bleeding from female genital tract.
627.0Premenopausal menorrhagia.
627.1Postmenopausal bleeding.
648.20-648.24Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium: Anemia.
698.0-698.9Pruritis and related conditions.
704.00-704.09Alopecia.
709.00-709.09Dyschromia.
719.40-719.49Pain in joint.
773.2Hemolytic disease due to other and unspecified isoimmunization.
773.3Hydrops fetalis due to isoimmunization.
773.4Kernicterus due to isoimmunization.
773.5Late anemia due to isoimmunization.
783.9Other symptoms concerning nutrition, metabolism and development.
790.0Abnormality of red blood cells.
790.4Nonspecific elevation of levels of transaminase or lactic acid dehydrogenase [LDH].
790.5Other nonspecific abnormal serum enzymelevels.
790.6Other abnormal blood chemistry.
799.4Cachexia.
964.0Poisoning by agents primarily affecting blood constituents, iron compounds.
984.0-984.9Toxic effect of lead and its compounds (including fumes).
996.85Complications of transplanted organ, bone marrow.
999.8Other transfusion reaction.
V08Asymptomatic HIV infection.
V12.1Personal history of nutritional deficiency.
V12.3Personal history of diseases of blood and blood forming organs.
V15.1Personal history of surgery to heart and great vessels.
V15.2Personal history of surgery to other major organs.
V43.2Heart replaced by other means.
V43.3Heart valve replaced by other means.
V43.4Blood vessel replaced by other means.
Start Printed Page 13124
V43.60Unspecified joint replaced by other means.
V72.84Pre-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:

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

CodeDescriptor
82523Collagen 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 Start Printed Page 13126treatment 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

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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
Start Printed Page 13127
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):Start Printed Page 13128

CodeDescriptor
82947Glucose; quantitative.
82948Glucose; blood, reagent strip.
82962Glucose, 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

CodeDescription
011.00-011.96Tuberculosis.
038.0-038.9Septicemia.
112.1Recurrent vaginal candidiasis.
112.3Interdigital candidiasis.
118Opportunistic mycoses.
157.4Malignant neoplasm of Islets of Langerhans.
158.0Malignant neoplasm of retroperitoneum.
211.7Benign neoplasm of Islets of Langerhans.
242.00-242.91Thyrotoxicosis.
250.00-250.93Diabetes mellitus.
251.0-251.9Disorders of pancreatic internal secretion.
253.0-253.9Disorders of the pituitary gland.
255.0Cushing syndrome.
263.0-263.9Malnutrition.
271.0-271.9Disorders of carbohydrate transport and metabolism.
272.0-272-4Disorders of lipoid metabolism.
275.0Hemochromotosis.
276.0-276.9Disorders of fluid, electrolyte and acid-base balance.
278.3Hypercarotinemia.
293.0Acute delirium.
294.9Unspecified organic brain syndrome.
298.9Unspecified psychosis.
300.9Unspecified neurotic disorder.
310.1Organic personality syndrome.
337.9Autonomic nervous system neuropathy.
345.10-345.11Generalized convulsive epilepsy.
348.3Encephalopathy, unspecified.
355.9Neuropathy, not otherwise specified.
356.9Unspecified hereditary and idiopathic peripheral neuropathy.
357.9Unspecified inflammatory and toxic neuropathy.
362.10Background retinopathy.
362.18Retinal vasculitis.
362.29Nondiabetic proliferative retinopathy.
362.50-362.57Degeneration of macular posterior pole.
362.60-362.66Peripherial retinal degeneration.
362-81-362.89Other retinal disorders.
362.0Unspecified retinal disorders.
365.-04Borderline glaucoma.
365.32Corticosteriod-induced glaucoma residual.
366.00-366.09Presenile cataract.
366.10-366.19Senile cataract.
367.1Acute myopia.
368.8Other specified visual disturbance.
Start Printed Page 13129
373.00Blepharitis.
377.24Pseudopapilledema.
377.9Autonomic nervous system neuropathy.
378.50-378.55Paralytic strabiamus.
379.45Argyll-Robertson pupils.
410.00-410.92Acute myocardial infarctions.
414.00-414.19Coronary atherosclerosis and aneurysm of heart.
425.9Secondary cardiomyopathy, unspecified.
440.23Arteriosclerosis of extremities with ulceration.
440.24Arteriosclerosis of extremities with gangrene.
440.9Arteriosclerosis, not otherwise specified.
458.0Postural hypotension.
462Acute pharyngitis.
466.0Acute bronchitis.
480.0-486Pneumonia.
490Recurrent bronchitis, not specified as acute or chronic.
491.0-491.9Chronic bronchitis.
527.7Disturbance of salivory secretion (drymouth).
528.0Stomatitis.
535.50-535.51Gastritis.
536.8Dyspepsia.
571.8Other chronic nonalcoholic liver disease.
572.0-.8Liver abscess and sequelae of chronic liver disease.
574.50-574.51Choledocholitiasis.
575.0-575.12Cholecystitis.
576.1Cholangitis.
577.0Acute pancreatitis.
577.1Chronic pancreatitis.
577.8Pancreatic multiple calculi.
590.00-590.9Infections of the kidney.
595.9Recurrent cystitis.
596.4Bladder atony.
596.53Bladder paresis.
599.0Urinary tract infection, recurrent.
607.84Impotence of organic origin.
608.89Other disorders male genital organs.
616.10Vulvovaginitis.
626.0Amenorrhea.
626.4Irregular menses.
628.9Infertility—female.
648.00Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, unspecified as to episode of care or not applicable.
648.03Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, antipartum condition or complication.
648.04Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, postpartum condition or complication.
648.80Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, unspecified as to episode of care or not applicable.
648.83Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, antipartum condition or complication.
648.84Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, postpartum condition or complication.
656.60-656.63Fetal problems affecting management of mother—large for-date of fetus.
657.00-657.03Polyhydramnios.
680.0-680.9Carbuncle and furuncle.
686.00-686.9Infections of skin and subcutaneous tissue.
698.0Pruritis ani.
698.1Pruritis of genital organs.
704.1Hirsutism.
705.0Anhidrosis.
707.0-707.9Chronic ulcer of skin.
709.3Degenerative skin disorders.
729.1Myalgia.
730.07-730.27Osteomyelitis of tarsal bones.
780.01Coma.
780.02Transcient alteration of awareness.
780.09Alteration of consciousness, other.
780.2Syncope and collapse.
780.39Seizures, not otherwise specified.
780.4Dizziness and giddiness.
780.71-.79Malaise and fatigue.
780.8Hyperhidrosis.
782.0Loss of vibratory sensation.
783.1Abnormal weight gain.
783.2Abnormal loss of weight.
783.5Polydipsia.
Start Printed Page 13130
785.0Tachycardia.
785.4Gangrene.
786.01Hyperventilation.
786.09Dyspnea.
786.50Chest pain, unspecified.
787.6Fecal incontinence.
787.91Diarrhea.
788.41-788.43Frequency of urination and polyuria.
789.1Hepatomegaly.
790.2Abnormal glucose tolerance test.
790.6Other abnormal blood chemistry (hyperglycemia).
791.0Proteinuria.
791.5Glycosuria.
796.1Abnormal reflex.
799.4Cachexia.
V23.0-.9Supervision of high risk pregnancy.
V67.2Follow-up examination, following chemotherapy.
V67.51Follow up examination with high-risk medication not elsewhere classified.
V58.69Long 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
Start Printed Page 13131
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13132be 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):

CodeDescriptor
82985Glycated protein.
83036Hemoglobin; 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

CodeDescription
211.7Benign neoplasm of islets of Langerhans.
250.00-250.93Diabetes mellitus & various related codes.
251.0Hypoglycemic coma.
251.1Other specified hypoglycemia.
251.2Hypoglycemia unspecified.
251.3Post-surgical hypoinsulinemia.
251.4Abnormality of secretion of glucagon.
251.8Other specified disorders of pancreatic internal secretion.
251.9Unspecified disorder of pancreatic internal secretion.
258.0-.9Polyglandular dysfunction.
271.4Renal glycosuria.
275.0Hemochromatosis.
577.1Chronic pancreatitis.
579.3Other and unspecified postsurgical nonabsorption.
648.00Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, unspecified as to episode of care or not applicable.
648.03Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, antepartum condition or complication.
648.04Diabetes mellitus complicating pregnancy, Childbirth or the puerperium, postpartum condition or complication.
648.80Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, unspecified as to episode of care or not applicable.
648.83Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, antepartum condition or complication.
648.84Abnormal glucose tolerance complicating pregnancy, childbirth or the puerperium, postpartum condition or complication.
790.2Abnormal glucose tolerance test.
790.6Other abnormal blood chemistry (hyperglycemia.)
962.3Poisoning by insulin and antidiabetic agents.
V12.2Personal history of endocrine, metabolic, and immunity disorders.
V58.69Long-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 Start Printed Page 13133necessary 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13134reason 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):

CodeDescriptor
84436Thyroxine; total.
84439Thyroxine; free.
84443Thyroid stimulating hormone (TSH).
84479Thyroid 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.

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 Start Printed Page 13137policy 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:

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13138screening. 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):

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

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 Start Printed Page 13139cholesterol (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

CodeDescription
242.00-245.9Disorders of the thyroid gland with hormonal dysfunction.
250.00-.93Diabetes mellitus.
255.0Cushing's syndrome.
260Kwashiorkor.
261Nutritional marasmus.
262Other severe, protein-calorie malnutrition.
263.0Malnutrition of moderate degree.
263.1Malnutrition of mild degree.
263.8Other protein-calorie malnutrition.
263.9Unspecified protein-calorie malnutrition.
270.0Disturbances of amino-acid transport.
271.1Galactosemia.
272.0Pure hypercholesterolemia.
272.1Hyperglyceridemia.
272.2Mixed hyperlipidemia (tuberous xanthoma).
272.3Hyperchylomicronemia.
272.4Other and unspecified hyperlipidemia (unspecified xanthoma).
272.5Lipoprotein deficiencies.
272.6Lipodystrophy.
272.7Lipidoses.
272.8Other disorders of lipoid metabolism.
272.9Unspecified disorders of lipoid metabolism.
277.3Amyloidosis.
278.01Morbid obesity.
303.90-303.92Alcoholism.
362.10-362.16Other background retinopathy and retinal vascular change.
362.30-362.34Retinal vascular occlusion.
362.82Retinal exudates and deposits.
371.41Corneal arcus, juvenile.
374.51Xanthelasma.
379.22Crystalline deposits in vitreous.
388.00Degenerative & vascular disorder of ear, unspecified.
388.02Transient ischemic deafness.
410.00-410.92Acute myocardial infarction.
411.0-411.1Other acute & subacute forms of ischemic heart disease.
411.81Coronary occlusion without myocardial infarction.
411.89Other acute and subacute ischemic heart disease.
412Old myocardial infarction.
413.0-413.1Angina pectoris.
413.9Other and unspecified angina pectoris.
414.00-414.03Coronary atherosclerosis.
414.04Coronary athrscl-artery bypass graft.
414.05Coronary athrscl-unspec graft.
414.10Aneurysm, heart (wall).
414.11Coronary vessel aneurysm.
Start Printed Page 13140
414.19Other aneurysm of heart.
414.8Other specified forms of chronic ischemic heart disease.
414.9Chronic ischemic heart disease, unspecified.
428.0-428.9Heart failure.
429.2Arteriosclerotic cardiovascular disease.
429.9Heart disease NOS.
431Intracerebral hemorrhage.
433.00-.91Occlusion & stenosis of precerebral arteries.
434.00-.91Occlusion of cerebral arteries.
435.0-.9Transient cerebral ischemia.
437.0Other & ill-defined cerebrovascular disease.
437.1Other generalized ischemic cerebrovascular disease.
437.5Moyamoya disease.
438.0-.9Late effects of cerebrovascular disease.
440.0-440.9Arteriosclerosis.
441.00-441.9Aortic aneurysms.
442.0Upper extremity aneurysm.
442.1Renal artery aneurysm.
442.2Iliac artery aneurysm.
444.0-.9Arterial embolism & thrombosis.
557.1Chronic vascular insufficiency of intestine.
571.8Other chronic non-alcoholic liver disease.
571.9Unspecified chronic liver disease without mention of alcohol.
573.8Other specified disorders of liver.
573.9Unspecified disorders of liver.
577.0-577.9Pancreatic disease.
579.3Other & unspecified postsurgical nonabsorption.
579.8Other specified intestinal malabsorption.
581.0-581.9Nephrotic syndrome.
584.5Acute renal failure with lesion of tubular necrosis.
585Chronic renal failure.
588.0Renal osteodystrophy.
588.1Nephrogenic diabetes insipidus.
588.8Other specified disorders resulting from impaired renal function.
588.9Unspecified disorder resulting from impaired renal function.
607.84Impotence of organic origin, penis disorder.
646.70-646.71Liver disorders in pregnancy.
646.73Liver disorder antepartum.
648.10-648.14Thyroid disfunction in pregnancy and the puerperium.
6.0Psoriatic arthropathy.
696.1Other psoriasis.
751.61Biliary atresia.
764.10-764.19“Light for dates” with signs of fetal malnutrition.
786.50Chest pain unspecified.
786.51Precordial pain.
786.59Chest pain, other.
789.1Hepatomegaly.
790.4Abnormal transaminase.
790.5Abnormal alkaline phosphatase.
790.6Other abnormal blood chemistry.
793.4Abnormal imaging study.
987.9Toxic effect of unspecified gas or vapor.
996.81Complication of transplanted organ, kidney, failure.
V42.0Transplanted organ, kidney.
V58.69Long 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 Start Printed Page 13141nonphysician 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

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

CodeDescriptor
80162Digoxin (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

CodeDescription
242.00-242.91Thyrotoxicosis with or without goiter.
243Congenital hypothyroidism.
244.0-244.9Acquired hypothyroidism.
245.0-245.9Thyroiditis.
275.2Disorders of magnesium metabolism.
275.40-.49Disorders of calcium metabolism.
276.0Hyperosmolality.
276.1Hyposmolality.
276.2Acidosis.
276.3Alkalosis.
276.4Mixed acid-base balance disorder.
276.5Volume depletion.
276.6Fluid overload.
276.7Hyperpotassemia.
276.8Hypopotassemia.
276.9Electrolyte and fluid disorder (not elsewhere classified).
293.0Acute delirium.
293.1Subacute delirium.
307.47Other dysfunctions of sleep stages or arousal from sleep.
368.16Psychophysical visual disturbances.
368.8Other specified visual disturbances.
368.9Unspecified visual disturbances.
397.9Rheumatic diseases of endocardium.
398.0Rheumatic myocarditis.
398.91Rheumatic heart Failure.
402.01Hypertensive heart disease, malignant with CHF.
402.11Hypertensive heart disease, benign with CHF.
402.91Hypertensive heart disease, unspecified with CHF.
403.00-403.91Hypertensive renal disease.
404.00-404.93Hypertensive heart & renal disease.
410.00-410.92Acute myocardial infarction.
411.0-411.89Other acute & subacute forms of ischemic heart disease.
413.0-413.9Angina pectoris.
Start Printed Page 13143
422.0-422.99Acute myocarditis.
425.0-425.9Cardiomyopathy.
426.0-426.9Conduction disorders.
427.0-427.9Cardiac dysrhythmias.
428.0-428.9Heart failure.
429.4Heart disturbances postcardiac surgery.
429.5Rupture chordae tendinae.
429.6Rupture papillary muscle.
429.71Acquired cardiac septal defect.
514Pulmonary congestion & hypostasis.
579.9Unspecified intestinal malabsorption.
584.5-584.9Acute renal failure.
585Chronic renal failure.
586Renal failure, unspecified.
587Renal sclerosis, unspecified.
588.0Renal osteodystrophy.
588.1Nephrogenic Diabetes Insipidus.
588.8Impaired renal function (not elsewhere classified).
588.9Unspecified disorder resulting from impaired renal function.
780.01Coma.
780.02Transient alteration of awareness.
780.09Other ill-defined general symptoms (drowsiness, semicoma, somnolence, stupor, unconsciousness).
780.1Hallucinations.
780.2Syncope & collapse.
780.4Dizziness and giddiness.
780.71-.79Malaise & fatigue.
783.0Anorexia.
784.0Headache.
787.01-787.03Nausea & vomiting.
787.91Diarrhea.
794.31Abnormal electrocardiogram.
799.2Nervousness.
972.1Poisoning by cardiotonic glycosides & drugs of similar action.
995.2Unspecified adverse effect of drug, medicinal and biological substance.
*E942.1Adverse effect of cardiotonic glycosides and drugs of similar action.
V58.69Encounter 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
Start Printed Page 13144
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):Start Printed Page 13145

CodeDescriptor
82105Alpha-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 alpha1-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

CodeDescription
070.22-070.23Chronic viral hepatitis B with hepatic coma, with or without mention of hepatitis delta
070.32-070.33Chronic viral hepatitis B without mention of hepatic coma, with or without mention of hepatitis delta
070.44Chronic hepatitis C with hepatic coma
070.54Chronic hepatitis C without mention of hepatic coma
095.3Syphilis of liver
121.1Clonorchiasis
121.3Fascioliasis
155.0-155.2Malignant neoplasm of the liver and intrahepatic bile ducts
164.2-164.9Malignant neoplasm of the mediastinum
183.0Malignant neoplasm, ovary
186.0Malignant neoplasm of undescended testis
186.9Malignant neoplasm, other and unspecific testis
197.1Secondary malignant neoplasm of mediastinum
197.7Secondary malignant neoplasm of liver
198.6Secondary malignant neoplasm of ovary
198.82Secondary malignant neoplasm, genital organs
211.5Benign neoplasm of liver and biliary passages
235.3Neoplasm of uncertain behavior of liver and biliary passages
272.2Mixed hyperlipidemia
275.0Disorder of iron metabolites
275.1Disorder of copper metabolism
277.00Cystic Fibrosis without mention of meconium ileus
277.6Other deficiencies of circulating enzymes
285.0Sideroblastic Anemia
571.2Alcoholic cirrhosis of liver
571.40Chronic hepatitis, unspecified
571.41Chronic persistent hepatitis
571.49Other chronic hepatitis
571.5Cirrhosis of liver without mention of alcohol
608.89Other specified disorders of male genital organs
793.1Non-specific abnormal findings of lung field
793.2Non-specific abnormal findings of other intrathoracic organs
793.3Non-specific abnormal findings of biliary tract
793.6Non-specific abnormal findings of abdominal area, including retro peritoneum
V10.07Personal history of malignant neoplasm, liver
V10.43Personal history of malignant neoplasm, ovary
V10.47Personal 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 Start Printed Page 13146devices is left to contractor discretion. (See 60 FR 48425, Sept. 19, 1995).

ICD-9-CM Codes Denied

  <HD2>ICD-9-CM Codes Denied

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):Start Printed Page 13147

CodeDescriptor
82378Carcinoembryonic 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

CodeDescription
150.0-150.9Malignant neoplasm of the esophagus.
151.0-151.9Malignant neoplasm of stomach.
152.0-154.8Malignant neoplasm of small intestine, including duodenum, rectum, rectosigmoid junction and anus.
157.0-157.9Primary malignancy of pancreas.
159.0Malignant neoplasm of intestinal tract, part unspecified.
162.0-162.9Malignant neoplasm of trachea, bronchus, lung.
174.0-174.9Malignant neoplasm of female breast.
175.0-175.9Malignant neoplasm of male breast.
183.0Malignant neoplasm of ovary.
197.0Secondary malignant neoplasm of neoplasm of lung.
197.4Secondary malignant neoplasm of small intestine.
197.5Secondary malignant neoplasm of large intestine and rectum.
230.3Carcinoma in situ of colon.
230.4Carcinoma in situ of rectum.
230.7Carcinoma in situ of other/unspecified parts of intestine.
230.9Carcinoma in situ other and unspecified digestive organs.
235.2Neoplasm of uncertain behavior of stomach, intestines, rectum.
790.99Other nonspecific findings on examination of blood.
V10.00Personal history of malignant neoplasm of gastro-intestinal tract, unspecified.
V10.3Personal history of malignant neoplasm, breast.
V10.05Personal history of malignant neoplasm, large intestine.
V10.06Personal history of malignant neoplasm, rectum, rectosigmoid junction, anus.
V10.11Personal history of malignant neoplasm, bronchus, and lung.
V10.43Personal history of malignant neoplasm, ovary.
V67.2Follow-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 Start Printed Page 13148Exemption (IDE). Coverage of Category B IDE devices is left to contractor discretion. (See 60 FR 48425, Sept. 19, 1995).

ICD-9-CM Codes Denied

CodeDescription
798.0-798.9 SSudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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. Start Printed Page 13149

Medicare National Coverage Decision for Human Chorionic Gonadotropin

Other Names/Abbreviations: hCG.

Description

Human chorionic gonadotropin

HCPCS Codes (Alpha numeric, CPT© AMA):

CodeDescriptor
84702Gonodotropin, 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

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

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: Start Printed Page 13150

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):Start Printed Page 13151

CodeDescriptor
Not yet assignedTumor 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

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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
Start Printed Page 13152
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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):

CodeDescriptor
Not yet assignedTumor 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 Start Printed Page 13153symptoms 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

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

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

CodeDescriptor
Not yet assignedTumor 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

CodeDescription
155.1Malignant neoplasm, intrahepatic bile ducts.
156.1Malignant neoplasm, extrahepatic bile ducts.
156.8Malignant neoplasm, other specified sites of gallbladder and extrahepatic bile ducts.
156.9Malignant neoplasm, unspecified part of biliary tract.
157.0-157.9Malignant neoplasm, pancreas.
197.8Secondary malignant neoplasm, other digestive organs and spleen.
235.3Neoplasm of uncertain behavior, liver and biliary passages.
235.5Neoplasm of uncertain behavior, other and unspecified digestive organs.
V10.09Other 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 Start Printed Page 13155exceeds 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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, Start Printed Page 13156symptoms, 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):

CodeDescriptor
84153Prostate 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

CodeDescription
185Malignant neoplasm of prostate.
188.5Malignant neoplasm of bladder neck.
196.5Secondary malignant neoplasm, lymph nodes inguinal region and lower limb.
196.6Secondary malignant neoplasm, intrapelvic lymph nodes.
196.8Secondary malignant neoplasm, lymph nodes of multiple sites.
198.5Secondary malignant neoplasm, bone and bone marrow.
198.82Secondary malignant neoplasm, genital organs.
233.4Carcinoma in situ, prostate.
239.5Neoplasm of unspecified nature, other genitourinary organs.
596.0Bladder neck obstruction.
599.7Hematuria.
601.9Unspecified prostatitis.
602.9Unspecified disorder of prostate.
788.20Retention of urine, unspecified.
788.21Incomplete bladder emptying.
790.93Elevated prostate specific antigen.
793.6/793.7Non-specific abnormal result of radiologic examination, evidence of malignancy.
794.9Bone scan evidence of malignancy.
V10.46Personal 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 Start Printed Page 13157has 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13158hepatobiliary 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):

CodeDescriptor
82977Glutamyltransferase, 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

CodeDescription
003.1Salmonella septicemia.
006.0-.9Amebiasis.
014.00-.86Tuberculosis of intestines, peritoneum, and mesenteric glands.
017.90-.96Tuberculosis of other specified organs.
018.90-.96Miliary tuberculosis, unspecified.
020.0-.9Plague.
022.3Anthrax septicemia.
027.0Listeriosis.
027.1Erysipelothrix infection.
030.1Tuberculoid leprosy [Type T].
032.83Diphtheritic peritonitis.
036.1Meningococcal encephalitis.
036.2Meningococcemia.
038.0-.9Septicemia.
039.2Actinomycotic infections, abdominal.
040.0Gas gangrene.
042Human immunodeficiency virus (HIV) disease.
054.0Eczema herpeticum.
054.5Herpetic septicemia.
060.0-.1Yellow fever.
070.0-.9Viral hepatitis.
072.71Mumps hepatitis.
073.0Ornithosis, with pneumonia.
074.8Other specified diseases due to Coxsackie virus.
075Infectious mononucleosis.
078.5Cytomegaloviral disease.
079.99Unspecified viral infection.
082.0-.9Tick-borne rickettsioses, stet.
084.9Other pernicious complications of malaria.
086.1Chagas disease with organ involvement other than heart.
088.81Lyme disease.
091.62Secondary syphilitic hepatitis.
095.3Syphilis of liver.
100.0Leptospirosis icterohemorrhagica.
Start Printed Page 13159
112.5Candidiasis, disseminated.
115.00Infection by Histoplasma capsulatum without mention of manifestation.
120.9Schistosomiasis, unspecified.
121.1Clonorchiasis.
121.3Fascioliasis.
122.0Echinococcus granulosus infection of liver.
122.5Echinococcus multilocularis infection of liver.
122.8Echinococcosis, unspecified, of liver.
122.9Echinococcus, other and unspecified.
130.5Hepatitis due to toxoplasmosis.
135Sarcoidosis.
150.0-159.9Malignant neoplasm of digestive organs and peritoneum.
160.0-165.9Malignant neoplasm of respiratory and intrathoracic organs.
170.0-176.9Malignant neoplasm of bone, connective tissue, skin, and breast.
179-189.9Malignant neoplasm of genitourinary organs.
200.00-208.91Malignant neoplasm of lymphatic and hematopoietic tissue.
211.5Benign neoplasm of liver and biliary passages.
211.6Benign neoplasm of pancreas, except islets of Langerhans.
211.7Benign neoplasm of islets of Langerhans.
228.04Hemangioma of intra-abdominal structures.
230.8Carcinoma in situ of liver and biliary system.
235.0-238.9Neoplasms of uncertain behavior.
239.0Neoplasm of unspecified nature of digestive system.
250.00-.93Diabetes mellitus.
252.0Hyperparathyroidism.
263.1Malnutrition of mild degree.
263.9Unspecified protein-calorie malnutrition.
268.0Rickets, active.
268.2Osteomalacia, unspecified.
269.0Deficiency of vitamin K.
270.2Other disturbances of aromatic amino acid metabolism.
270.9Unspecified disorder of amino acid metabolism.
271.0Glycogenosis.
272.0Pure hypercholesterolemia.
272.1Pure hyperglyceridemia.
272.2Mixed hyperlipidemia.
272.4Other and unspecified hyperlipidemia.
272.7Lipidoses.
272.9Unspecified disorder of lipoid metabolism.
275.0Disorders of iron metabolism.
275.1Disorders of copper metabolism.
275.3Disorders of phosphorus metabolism.
275.40-.49Disorders of calcium metabolism.
277.1Disorders of porphyrin metabolism.
277.3Amyloidosis.
277.4Disorders of bilirubin excretion.
277.6Other deficiencies of circulating enzymes.
282.60-.69Sickle cell anemia.
286.6Defibrination syndrome.
286.7Acquired coagulation factor deficiency.
289.4Hypersplenism.
291.0-.9Alcoholic psychoses.
303.00-.03Acute alcoholic intoxication.
303.90-.93Other and unspecified alcohol dependence.
304.0-.9Drug dependence.
305.00-.93Non-dependent abuse of drugs.
357.5Alcoholic polyneuropathy.
359.2Myotonic disorders.
452Portal vein thrombosis.
453.0-.9Other vein embolism and thrombosis.
456.0-.21Esophageal varices.
555.0-.9Regional enteritis.
556.0-.9Ulcerative colitis.
557.0Acute vascular insufficiency of intestine.
558.1-.9Other noninfectious gastroenteritis and colitis.
560.0-.9Intestinal obstruction without mention of hernia.
562.01Diverticulitis of small intestine (without mention of hemorrhage).
562.03Diverticulitis of small intestine with hemorrhage.
562.11Diverticulitis of colon (without mention of hemorrhage).
562.13Diverticulitis of colon with hemorrhage.
567.0-.9Peritonitis.
569.83Perforation of intestine.
570Acute and subacute necrosis of liver.
571.0-.9Chronic liver disease and cirrhosis.
Start Printed Page 13160
572.0-.8Liver abscess and sequelae of chronic liver disease.
573.0-.9Other disorders of liver.
574.00-.91Cholelithiasis.
575.0-.9Other disorders of gallbladder.
576.0-.9Other disorders of biliary tract.
581.0-.9Nephrotic syndrome.
582.0-.9Chronic glomerulonephritis.
583.0-.9Nephritis and nephropathy not specified as acute or chronic.
584.5-.9Acute renal failure.
585Chronic renal failure.
586Renal failure, unspecified.
587Renal sclerosis, unspecified.
588.0-.9Disorders resulting from impaired renal function
590.00-.9Infections of kidney.
646.7Liver disorders in pregnancy.
960.0-979.9Poisoning by drugs, medicinal, and biological substances.
980.0-989.89Toxic effects of substances chiefly nonmedical as to source.
V58.61-.69Long term (current) drug use.
V67.1Follow-up examination, radiotherapy.
V67.2Follow-up examination, chemotherapy.
V67.51Follow-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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
Start Printed Page 13161
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13162marker 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):

CodeDescriptor
80059Hepatitis 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

CodeDescription
070.0-.9Viral hepatitis.
456.0-.21Esophageal varices with or without mention of bleeding.
570Acute and subacute necrosis of liver.
571.5Cirrhosis of liver without mention of alcohol.
572.0-.8Liver abscess and sequelae of chronic liver disease.
573.3Hepatitis, unspecified.
780.31Febrile convulsions.
780.71Chronic fatigue syndrome.
780.79Other malaise and fatigue.
782.4Jaundice, unspecified, not of newborn.
783.0-.6Symptoms concerning nutrition, metabolism, and development.
784.69Other symbolic dysfunction.
787.01-.03Nausea and vomiting.
789.00-.09Abdominal pain.
789.1Hepatomegaly.
789.6Localized abdominal tenderness (RUQ).
794.8Nonspecific abnormal results of function studies, liver.
999.3Other infection following infusion, injection, trans fusion, or vaccination.
996.82Complications of transplanted organ, liver.
V72.85Liver 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 Start Printed Page 13163Laboratory 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13164provided, 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):

CodeDescriptor
82270Blood, 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

CodeDescription
004.0-.9Shigellosis.
005.0-.9Other food poisoning (bacterial).
006.0-.9Amebiasis.
007.0-.9Other protozoal intestinal diseases.
008.41-.49Intestinal infections due to other specified bacteria.
009.0-.3Ill defined intestinal infections.
014.00-.86Tuberculosis of intestines, peritoneum, and mesenteric glands.
022.2Gastrointestinal anthrax.
040.2Whipple's disease.
123.0-.9Other cestode infection.
124Trichinosis.
127.0-.9Other intestinal helminthiases.
150.0-157.9Malignant neoplasm of digestive organisms.
176.3Kaposi's sarcoma, gastrointestinal sites.
197.4-.5Secondary malignant neoplasm of intestines.
197.8Secondary malignant neoplasm of other digestive organs and spleen.
199.0Disseminated malignant neoplasm.
204.00-.91Lymphoid leukemia.
205.00-208.91Leukemia.
211.0-.9Benign neoplasm of other parts of digestive system.
228.04Hemangioma of intra-abdominal structures.
230.2-.9Carcinoma in situ of digestive organs.
Start Printed Page 13165
235.2Neoplasm of uncertain behavior of stomach, intestines, and rectum.
235.5Neoplasm of uncertain behavior of other and unspecified digestive organs.
239.0Neoplasm of unspecified nature, digestive system.
280.0-.9Iron deficiency anemias.
285.0-.9Other and unspecified anemias.
286.0-.9Coagulation defects.
287.0-.9Purpura and other hemorrhagic conditions.
448.0Hereditary hemorrhagic telangiectasia.
455.0-.8Hemorrhoids.
456.0-.21Esophageal varices with or without mention of bleeding.
530.10-535.61Diseases of the esophagus, stomach, and duodenum.
536.2Persistent vomiting.
536.8-.9Dyspepsia and other specified and unspecified functional disorders of the stomach.
537.0-.4Other disorders of stomach and duodenum.
537.82-.83Angiodysplasia of stomach and duodenum.
537.89Other specified disorders of stomach and duodenum.
555.0-558.9Non-infectious enteritis and colitis.
560.0-.39Intestinal obstruction/impaction without mention of hernia.
562.10-.13Diverticulosis/diverticulitis of colon.
564.0-.9Functional digestive disorders, not elsewhere classified.
565.0-.1Anal fissure and fistula.
569.0Anal and rectal polyp.
569.1Rectal prolapse.
569.3Hemorrhage of rectum and anus.
569.41-.49Other specified disorders of rectum and anus.
569.84-.85Angiodysplasia of intestine with or wihout mention of hemorrhage.
571.0-.9Chronic liver disease and cirrhosis.
577.0Acute pancreatitis.
577.0-.9Diseases of the pancreas.
578.0-.9Gastrointestinal hemorrhage.
579.0Celiac disease.
579.8Other specified intestinal malabsorption.
617.5Endometriosis of intestine.
780.71Chronic fatigue syndrome.
780.79Other malaise and fatigue.
783.0Anorexia.
783.2Abnormal loss of weight.
787.01-.03Nausea and vomiting.
787.1Heartburn.
787.2Dysphagia.
787.7Abnormal feces.
787.91Diarrhea.
787.99Other symptoms involving digestive system.
789.00-.09Abdominal pain.
789.30-.39Abdominal or pelvic swelling, mass, or lump.
789.40-.49Abdominal rigidity.
789.5Ascites.
789.60-.69Abdominal tenderness.
790.92Abnormal coagulation profile.
792.1Nonspecific abnormal findings in stool contents.
793.6Nonspecific abnormal findings on radiological and other examination, abdominal area, including retroperitoneum.
794.8Nonspecific abnormal results of function studies, liver.
863.0-.90Injury to gastrointestinal tract.
864.00-.09Injury to liver without mention of open wound into cavity.
864.11-.19Injury to liver with open wound into cavity.
866.00-.03Injury to kidney without mention of open wound into cavity.
866.10-.13Injury to kidney with open wound into cavity.
902.0 -.9Injury to blood vessels of abdomen and pelvis.
926.11-.19Crushing injury of trunk, other specified sites.
926.8Crushing injury of trunk, multiple sites.
926.9Crushing injury of trunk, unspecified site.
964.2Poisoning by agents primarily affecting blood constituents, anticoagulants.
995.2Unspecified adverse effect of drug, medicinal, and biological substance.
V10.00-.09Personal history of malignant neoplasm, gastrointestinal tract.
V12.00Personal history of unspecified infectious and parasitic disease.
V12.72Personal history of colonic polyps.
V58.61Long term (current) use of anticoagulants.
V58.69Long term (current) use of other medications.
V67.51Following treatment with high risk medication, not elsewhere specified.
Start Printed 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

CodeDescription
798.0-798.9Sudden death, cause unknown.
V15.85Exposure to potentially hazardous body fluids.
V16.1Family history of malignant neoplasm, trachea, bronchus, and lung.
V16.2Family history of malignant neoplasm, other respiratory and intrathoracic organs.
V16.4Family history of malignant neoplasm, genital organs.
V16.5Family history of malignant neoplasm, urinary organs.
V16.6Family history of malignant neoplasm, leukemia.
V16.7Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.
V16.8Family history of malignant neoplasm, other specified malignant neoplasm.
V16.9Family history of malignant neoplasm, unspecified malignant neoplasm.
V17.0-V17.8Family history of certain chronic disabling diseases.
V18.0-V18.8Family history of certain other specific conditions.
V19.0-V19.8Family history of other conditions.
V20.0-V20.2Health supervision of infant or child.
V28.0-V28.9Antenatal screenings.
V50.0-V50.9Elective surgery for purposes other than remedying health states.
V53.2Fitting and adjustment of hearing aid.
V60.0-V60.9Housing, household, and economic circumstances.
V62.0Unemployment.
V62.1Adverse effects of work environment.
V65.0Healthy persons accompanying sick persons.
V65.1Persons consulting on behalf of another person.
V68.0-V68.9Encounters for administrative purposes.
V70.0-V70.9General medical examinations.
V73.0-V73.99Special screening examinations for viral and chlamydia diseases.
V74.0-V74.9Special screening examinations for bacterial and spirochetal diseases.
V75.0-V75.9Special screening examination for other infectious diseases.
V76.0Special screening for malignant neoplasms, respiratory organs.
V76.3Special screening for malignant neoplasms, bladder.
V76.42-V76.9Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).
V77.0-V77.9Special screening for endocrine, nutrition, metabolic, and immunity disorders.
V78.0-V78.9Special Screening for disorders of blood and blood-forming organs.
V79.0-V.79.9Special screening for mental disorders.
V80.0-V80.3Special screening for neurological, eye, and ear diseases.
V81.0-V81.6Special screening for cardiovascular, respiratory, and genitourinary diseases.
V82.0-V82.9Special 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 Start Printed Page 13167narrative. 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.

End Part End Supplemental Information

[FR Doc. 00-4834 Filed 3-9-00; 8:45 am]

BILLING CODE 4210-01-P