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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 410

[HCFA-3250-P]

RIN 0938-AJ53

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

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would establish national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B to promote Medicare program integrity and national uniformity, and simplify administrative requirements for clinical diagnostic laboratory services. A Negotiated Rulemaking Committee (the Committee) developed the proposed policies as directed by section 4554(b)(1) of the Balanced Budget Act of 1997 (the BBA).

DATES:

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

ADDRESSES:

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

If you prefer, you may deliver your written comments (1 original and 3 copies) to one of the following addresses:

Room 443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or

Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-8016.

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

FOR FURTHER INFORMATION CONTACT:

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

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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.

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:

• 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

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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

encourage readers to refer to the claims processing sections of the Medicare Carriers Manual (section 3005 and 3999, exhibit 10) and Medicare Fiscal Intermediary Manual (section 3605 and Addendum L) in order to keep current regarding the specific policies related to data elements. As noted above, these manuals are posted on the Internet at http://www.hcfa.gov/pubforms/progman.htm.

2. Diagnostic Information Requirement

The Committee discussed when diagnostic information to support medical necessity must be submitted with a claim. The discussion focused on whether diagnostic information should be required on claims for all tests, even those not addressed by a national coverage policy or LMRP. Some Committee members emphasized that providing information on the reason for the patient visit or for the test would be useful in evaluating patient outcomes and quality of care and would ensure consistency and simplicity. Physicians' representatives expressed concern, however, about the burden that may be involved in providing the information. Laboratory representatives expressed concern about laboratories' ability to be paid if the physician does not provide the information.

The Committee concurred that this proposed rule would not promulgate a requirement that diagnostic information be submitted with every claim; however, there may be other requirements for a diagnosis code with every claim. The Committee recommended, however, that physicians be encouraged voluntarily to provide diagnosis information (either the reason for the visit or the reason for the test) with the order, and laboratories be encouraged to submit information that they receive with the claim.

3. Date of Service

The date of service is a required data field for laboratory claims. A laboratory service may take place over a period of time. That is, the date the physician orders the test, the date the specimen is collected from the patient, the date the laboratory accesses the specimen, the date of the test, and the date results are produced may not be the same. For example, often several days elapse between taking a sample and producing results in microbiology tests that are cultured. The Committee discussed what “date of service” laboratories must report on claims for clinical diagnostic laboratory services. To ensure equitable treatment of beneficiaries and providers, as well as to promote national claims processing consistency, it is necessary that all laboratories report this date consistently.

Laboratory representatives reported that some laboratory computer systems are programmed to report the date of acquisition of the specimen or the date of accession (the date the test is entered into the computer system), in the date of service field on the claim form. In addition, Medicare issued Program Memorandum A-9J-4 in April, 1995 that instructed some laboratories, primarily hospital-based laboratories, to report the date of performance as the date of service on automated multi-channel tests.

After considerable discussion the Committee reached consensus that the date of service for Medicare claim purposes should be the date the tested specimen was collected and that the person obtaining the specimen must furnish the date of collection of the specimen to the entity billing Medicare. However, the Committee felt that further input was needed to make an informed decision to determine appropriate date of service for Medicare claim purposes. We are committed to the concept that we should establish a national policy regarding date of service for Medicare claims that will promote program integrity and national uniformity, yet minimize the burden on laboratories. Therefore, we are specifically soliciting public comment on this issue from organizations serving on the Negotiated Rulemaking as well as others. As discussed below in “Effective Date of Provisions”, we are proposing to provide a grace period of up to 12 months after the effective date of the final rule to accommodate any system changes required by the policy changes or clarifications resulting from the Committee's negotiations. Laboratories will have up to 24 months (12 months delayed effective date and up to 12 months grace period for system changes) after publication of the final rule to achieve system modification to submit claims in accordance with the final policy on date of service.

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

Note:

Label comments about this section with the subject: “National Coverage Decisions”.

Section 4554(b)(2) of the Act instructs the Committee to consider the medical conditions for which a laboratory test is considered reasonable and necessary (within the meaning of section 1862(a)(1)(A) of the Act) in developing national coverage policies. These policies must be designed to promote program integrity and national uniformity and simplify administrative requirements. We are promulgating these policies as “national coverage decisions” under section 1862(a)(1) of the Act, as defined in § 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.

• 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.

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).

• 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

payment denial if documentation does not support the medical necessity of the claim, the Committee agreed that the basic premise that Medicare would seek additional diagnostic and other medical information from the entity that usually maintains that documentation—the ordering physician—does not preclude the laboratory from requesting additional diagnostic or other medical information from the ordering provider. In making requests for additional information, laboratories must focus their request for additional information on material relevant to medical necessity. In addition, documentation requests must take into account current rules and regulations related to patient confidentiality that are applicable in the area where the physician is practicing.

Similar to proposed paragraph (d)(2)(iii) of § 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

claims processing system in order to use this information for automated claims processing, the additional diagnoses would only be used by the contractor in processing claims that were suspended for manual review.

3. Matching of Diagnosis to Procedure

All Medicare contractors presently process claims using any diagnosis-to-procedure code matching supplied by the laboratory. Some Committee members wished to find a way to have contractors examine all submitted codes. The Committee consensus was that, in the absence of matching of codes supplied by the laboratory, Medicare contractors must examine all submitted codes on prepayment review, taking into account program integrity concerns. Claims will not be denied solely because there is no matching of diagnosis and procedure codes on the claim form. We will include this clarification in future instructions to our contractors.

The Committee also discussed ways of avoiding denial of an entire claim if it is submitted with diagnosis codes for multiple procedures (tests) and one of the diagnosis codes indicates screening, but the laboratory does not link the diagnosis and procedure codes. The Committee was concerned that absent information indicating which test(s) is performed for which diagnosis, the contractor may deny all of the claimed services after examining the diagnosis codes.

The Committee consensus was that laboratories have the option of submitting a separate claim for the procedure that is not covered by Medicare. We would instruct the Medicare contractors to allow this option.

In order to ensure that noncovered procedures can be identified, ordering providers must supply to the laboratory the necessary information to specifically identify any noncovered test ordered, such as a test ordered for screening purposes. When this information is supplied to the laboratory, the laboratory must supply this information with any claim for the noncovered service. For example, when an ICD-9-CM code that indicates screening is provided by the physician, the laboratory must either submit a separate claim for the procedure that is not covered by Medicare or match that code on a claim form with the CPT code(s) provided for that purpose.

F. Limitation on Frequency

Note:

Label comments about this section with the subject: “Frequency”.

Section 4554(b)(2) of the BBA instructs the Committee to negotiate policies that take into consideration “Limitations on frequency of coverage for the same tests performed on the same individual.”

1. Notice of Frequency Screens

The Committee discussed the use of frequency screens and their impact on the laboratory community. Some Committee members noted that, since frequency screens are a program integrity tool and therefore are not published, there is no means for a laboratory to know when a claim would be reviewed and perhaps denied in the absence of additional documentation of medical necessity. After studying the data on frequency denials and discussing the issue, we agreed that a frequency screen would not result in a frequency-based denial unless information published by us or our contractor includes an indication of the frequency that is generally considered reasonable utilization of that test for Medicare payment purposes.

We will issue instructions to Medicare contractors through a revision to the program integrity sections of the Medicare Carriers Manual and Fiscal Intermediary Manual. In the future, we will be moving this information to the Program Integrity Manual. These instructions will provide that, except for egregious utilization, contractors may not use a frequency screen that could result in a frequency-based denial unless the contractor has published information about the appropriate frequency for the service or unless we have published information about the appropriate frequency in a national coverage decision. The information regarding appropriate frequency either may include the frequency with which the service is generally considered reasonable utilization for Medicare purposes or may be an absolute limit on coverage. The information must be published in advance of implementation of a frequency screen in a form, such as a contractor bulletin, that is widely disseminated to affected providers and suppliers. The contractor must consult with appropriate advisors, including medical specialty and other organizations before developing and publishing local frequency information for a clinical diagnostic laboratory test. Local frequency information for a particular test may not conflict with a national coverage decision or policy that includes frequency information for that test.

If a Medicare contractor has been applying a frequency screen in the absence of published information about the frequency expectation, the contractor must either publish information about the appropriate frequency or stop using the frequency screen. Frequency screens that can result in denial must not be more restrictive than the frequency described in the published information. Contractors may, however, continue to deal with egregious utilization without prior publication of frequency information by using Category III edits described in section 7506.2 of the Medicare Carriers Manual, which are typically provider specific.

2. Automatic Denial and Manual Review

The Committee discussed Medicare policy on automatic denials of laboratory claims as the policy applies to frequency screens. The Committee consensus is that the current policy regarding automatic denial and manual review of claims as stated in Medicare Carriers Manual sections 7505.1 and 7506 is appropriate and should be codified in regulations.

We are proposing to add a new paragraph (d)(4) to § 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

receipt of services, and may be confusing to beneficiaries. Some members of the Committee expressed concern that such a mechanism may have the unintended effect of beneficiaries failing to receive necessary services. The Committee could not agree to a specific proposal and therefore we are soliciting new ideas for addressing this problem from Committee members as well as others. We are especially interested in ideas that include shared responsibility for solving the problem.

4. Consistent Remittance Message

Some Committee Members expressed concern that HCFA may not be using a consistent denial message to indicate claims that are denied for excess frequency. We agreed to instruct the Medicare claims processing contractors (carriers and fiscal intermediaries) to consistently use remittance advice language that identifies the reason for denial as excessive frequency. The language would read as follows: “Claim/service denied/reduced because the payer deems the information submitted does not support this level of service, this many services, this length of service or this dosage.”

IV. Other Topics Discussed by the Committee

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

V. Provisions of the Proposed Regulations

This proposed rule would establish uniform national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B. This proposed rule would promote Medicare program integrity and national uniformity and would simplify administrative requirements for clinical diagnostic laboratory services. These regulations do not provide, or purport to provide, any immunities or safe harbors. Additionally, these regulations do not limit any criminal, civil, or administrative law enforcement and overpayment actions. These Medicare policies apply to all Medicare contractors processing Part B laboratory claims, including fiscal intermediaries. The changes we would make to 42 CFR part 410 are set forth as follows:

• We are proposing to redesignate paragraph (d) introductory text as paragraph (d)(1) and adding a heading.

• We are proposing to redesignate paragraphs (d)(1) through (d)(7) as paragraphs (d)(1)(i) through (d)(1)(vii).

• We are proposing to add a new paragraph (d)(2) to § 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

regarding the decisions and their impact upon claims payment. They were also concerned that there be adequate opportunity to modify computer systems to accommodate these provisions.

The Committee reached consensus to recommend that changes arising from these actions would become effective 12 months after publication of the final regulation. Further, it recommended a grace period of not more than 12 months after the effective date of the changes be available for any system changes any party is required to make. In modifying claims processing systems for the proposed changes, we will give priority to implementation of the national coverage decisions. We are proposing to delay the effective date of this proposed rule and national coverage decisions in accordance with the Committee's consensus recommendation.

The Committee also discussed a strategy to communicate the changes to affected parties. Many members of the Committee will continue to work together in further developing a plan through which they could adequately inform the community, especially physicians and laboratories, of the provisions of this proposed rule and the national coverage decisions. We will instruct the contractors to issue a bulletin to notify affected providers, such as physicians, hospitals, and laboratories, of the policies. Within 90 days of receiving this instruction from us, contractors must issue the bulletin at least 90 days before the effective date of the policy and national coverage decision.

VII. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the

Federal Register

and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements:

Documentation and Recordkeeping Requirements

In summary, § 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

Order (EO) 12866, the Unfunded Mandates Reform Act of 1995, and the Regulatory Flexibility Act (RFA) (Public Law 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more annually).

Section 1102(b) of the Social Security Act (the Act) requires us to prepare a regulatory impact analysis (RIA) if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds.

A. Executive Order 12866

The intent of this Proposed rule is to promote program integrity and national uniformity and simplify administrative procedures for clinical diagnostic laboratory services. We do not expect the provisions of this proposed rule to have a significant cost effect upon providers or suppliers. The provisions of the proposed rule, for the most part, are administrative and state explicitly and codify practices that are currently in effect. That is, physicians maintain documentation in the medical record and laboratories maintain the information that is provided to them. We expect no cost consequence of codifying this common practice.

Similarly, we do not anticipate a cost effect of the provision related to the documentation that must be submitted upon claims review. While some Medicare contractors presently request medical record information directly from laboratories, the laboratories must in turn seek the information from the physicians. Requiring Medicare contractors to seek medical record information directly from physicians may result in a minimal increase in the administrative cost of conducting claims review. We anticipate that there would be offsetting savings from reduced Medicare contractor requests to laboratories for documentation. This would result in a decreased documentation burden to the laboratories.

The provision in § 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

clinical diagnostic laboratory services. Thus, to the extent that payment is presently being made for these services, we believe it is inappropriate and should be curtailed.

We do not expect any beneficiary to be deprived of medically necessary services as a result of these provisions. Nor do we expect that there would be an impact upon the availability of covered services to beneficiaries. Beneficiaries may, however, experience a minimal increase in out-of-pocket costs if they choose to have testing that is not covered by Medicare. That is, publication of clear decisions regarding when a test is considered medically necessary may prompt physicians and laboratories to execute advanced beneficiary notices and charge patients for noncovered services, when they may not have followed these procedures due to ambiguity regarding whether the service would be covered by Medicare.

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

For these reasons, the Secretary certifies, that this rule would not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

We have reviewed this proposed rule under the threshold criteria of Executive Order 13132. We have determined that it does not significantly affect States' rights, roles, and responsibilities.

List of Subjects in Part 410

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

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

PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

Subpart B—Medical and Other Health Services

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

Authority:

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

2. In § 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:

§ 410.32

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

(d)

Diagnostic laboratory tests

—(1)

Who may furnish services

. * * *

(2)

Documentation and recordkeeping requirements.

(i)

Ordering the service.

The physician or (qualified nonphysican practitioner, as defined in paragraph (a)(3) of this section), who orders the service must maintain documentation of medical necessity in the beneficiary's medical record.

(ii)

Submitting the claim.

The entity submitting the claim must maintain the following documentation:

(A) The documentation that it receives from the ordering physician.

(B) The documentation that the information that it submitted with the claim accurately reflects the information it received from the ordering physician.

(iii)

Requesting additional information.

The entity submitting the claim may request additional diagnostic and other medical information to document that the services it bills are reasonable and necessary. If the entity requests additional documentation, it must request material relevant to the medical necessity of the specific test(s), taking into consideration current rules and regulations on patient confidentiality.

(3) Claims review. (i)

Documentation requirements.

Upon request by HCFA, the entity submitting the claim must provide the following information :

(A) Documentation of the physician's order for the service billed (including information sufficient to enable HCFA to identify and contact the ordering physician).

(B) Documentation showing accurate processing of the order and submission of the claim.

(C) Diagnostic or other medical information supplied to the laboratory by the ordering physician, including any ICD-9-CM code or narrative description supplied.

(ii)

Services that are not reasonable and necessary.

If the documentation provided under paragraph (d)(3)(i) of this section does not demonstrate that the service is reasonable and necessary, HCFA takes the following actions:

(A) Provides the ordering physician information sufficient to identify the claim being reviewed.

(B) Requests from the ordering physician those parts of a beneficiary's medical record that are relevant to the specific claim(s) being reviewed.

(C) If the ordering physician does not supply the documentation requested, informs the entity submitting the claim(s) that the documentation has not been supplied and denies the claim.

(iii)

Medical necessity.

The entity submitting the claim may request additional diagnostic and other medical information from the ordering physician to document that the services it bills are reasonable and necessary. If the entity requests additional documentation, it must request material relevant to the medical necessity of the specific test(s), taking into consideration current rules and regulations on patient confidentiality.

(4)

Automatic denial and manual review

—(i)

General rule.

Except as provided in paragraph (d)(4)(ii) of this section, HCFA does not deny a claim for services that exceeds utilization parameters without reviewing all relevant documentation submitted with the claim (for example, justifications prepared by providers, primary and secondary diagnoses, and copies of medical records).

(ii)

Exceptions.

HCFA may automatically deny a claim without manual review under the following circumstances:

(A) A national coverage decision or LMRP specifies the circumstances under which the service is denied, or the service is specifically excluded from Medicare coverage by statute.

(B) HCFA determines that a specific provider or supplier has engaged in egregious overutilization of a particular service, and the claim is for that service.

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

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

Dated: July 9, 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.

Dated: November 24, 1999.

Donna E. Shalala,

Secretary.

Note:

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

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

Purpose

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

What Is a National Coverage Policy?

Part B of title XVIII of the Social Security Act (the Act) provides for Supplementary Medical Insurance (SMI) for certain Medicare beneficiaries, specifying what health care items or services will be covered by the Medicare Part B program. Diagnostic laboratory tests are generally covered under Part B, unless excluded from coverage by the Act. Services that are generally excluded from coverage include routine physical examinations and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury. HCFA interprets these provisions to prohibit coverage of screening services, including laboratory tests furnished in the absence of signs, symptoms, or personal history of disease or injury, except as explicitly authorized by statute. A test may be considered medically appropriate, but nonetheless be excluded from Medicare coverage by statute.

A national coverage policy for diagnostic laboratory test(s) is a document stating HCFA's policy with respect to the circumstances under which the test(s) will be considered reasonable and necessary, and not screening, for Medicare purposes. Such a policy applies nationwide. A national coverage policy is neither a practice parameter nor a statement of the accepted standard of medical practice. Words such as “may be indicated” or “may be considered medically necessary” are used for this reason. Where a policy gives a general description and then lists examples (following words like “for example” or “including”), the list of examples is not meant to be all inclusive but merely to provide some guidance.

What Is the Effect of a National Coverage Policy?

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

What Is the Format for These National Coverage Policies?

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

National Coverage Policy For

This section identifies the official title of the policy.

Other Names/Abbreviations

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

Description

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

Descriptor(s)

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

Indications

section.

Indications

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

Limitations

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

ICD-9-CM Codes Covered by Medicare Program

Code:   Description

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

Reasons for Denial

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

ICD-9-CM Codes Denied

Code:   Description

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

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

Code:   Description

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

Sources of Information

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

Coding Guidelines

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

Documentation Requirements

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

Other Comments

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

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

To develop national coverage policies for the tests assigned to each Workgroup, the Committee agreed to use one of two approaches, referred to as “inclusionary” and “exclusionary”. Policies using the “inclusionary” approach list the ICD-9-CM codes in the following two categories: ICD-9-CM Codes Covered by Medicare Program and ICD-9-CM Codes Denied. These policies do not list the codes that require additional documentation to support medical necessity.

The exclusionary approach was used for tests for which local medical review policies had identified a large number of acceptable ICD-9-CM codes. The Committee used this approach to develop a proposed policy on blood counts. In lieu of listing all the ICD-9-CM codes that support medical necessity of a test or group of tests, policies using the “exclusionary” approach list ICD-9-CM codes in the following two categories: ICD-9-CM Codes Denied and ICD-9-CM Codes That Do Not Support Medical Necessity.

Addendum B—National Coverage Decisions

Medicare National Coverage Decision:

Culture, Bacterial, Urine.

Other Names/Abbreviations:

Urine culture.

Description

.

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

HCPCS Codes:

(alpha numeric, CPT

©

AMA):

Code:

Descriptor:

87086

Culture, bacterial, urine; quantitative, colony count.

87087

Culture, bacterial, urine; commercial kit.

87088

Culture, bacterial, urine; identification, in addition to quantitative or commercial kit.

87184

Sensitivity studies, antibiotic; disk method, per plate (12 or fewer disks).

87186

Sensitivity studies, antibiotic; microtiter, minimum inhibitory concentration (MIC), any number of antibiotics.

Indications

1. A patient's urinalysis is abnormal suggesting urinary tract infection, for example, abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis (positive leukocyte esterase, nitrite, protein, blood); a Gram's stain positive for microorganisms; positive bacteriuria screen by a non-culture technique; or other significant abnormality of a urinalysis. While it is not essential to evaluate a urine specimen by one of these methods before a urine culture is performed, certain clinical presentations with highly suggestive signs and symptoms may lend themselves to an antecedent urinalysis procedure where follow-up culture depends upon an initial positive or abnormal test result.

2. A patient has clinical signs and symptoms indicative of a possible urinary tract infection (UTI). Acute lower UTI may be present with urgency, frequency, nocturia, dysuria, discharge or incontinence. These findings may also be noted in upper UTI with additional systemic symptoms (for example, fever, chills, lethargy); or pain in the costovertebral, abdominal, or pelvic areas. Signs and symptoms may overlap considerably with other inflammatory conditions of the genitourinary tract (for example, prostatitis, urethritis, vaginitis, or cervicitis). Elderly or immunocompromised patients, or patients with neurologic disorders may present atypically (for example, general debility, acute mental status changes, declining functional status).

3. The patient is being evaluated for suspected urosepsis, fever of unknown origin, or other systemic manifestations of infection but without a known source. Signs and symptoms used to define sepsis have been well-established.

4. A test-of cure is generally not indicated in an uncomplicated infection. However, it may be indicated if the patient is being evaluated for response to therapy and there is a complicating co-existing urinary abnormality including structural or functional abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or laboratory evidence of failure to respond as described in Indications 1 and 2.

5. In surgical procedures involving major manipulations of the genitourinary tract, preoperative examination to detect occult infection may be indicated in selected cases (for example, prior to renal transplantation, manipulation or removal of kidney stones, or transurethral surgery of the bladder or prostate).

6. Urine culture may be indicated to detect occult infection in renal transplant recipients on immunosuppressive therapy.

Limitations

1. CPT 87086 or 87087 may be used one time per encounter. CPT 87086 and 87087 are not used concurrently.

2. Colony count restrictions on coverage of CPT 87088 do not apply as they may be highly variable according to syndrome or other clinical circumstances (for example , antecedent therapy, collection time, degree of hydration).

3. CPT 87088, 87184, and 87186 may be used multiple times in association with or independent of 87086 or 87087, as urinary tract infections may be polymicrobial.

4. Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be medically appropriate but is considered screening and therefore not covered by Medicare. The US Preventive Services Task Force has concluded that screening for asymptomatic bacteriuria outside of the narrow indication for pregnant women is generally not indicated. There are insufficient data to recommend screening in ambulatory elderly patients including those with diabetes. Testing may be clinically indicated on other grounds including likelihood of recurrence or potential adverse effects of antibiotics, but is considered screening in the absence of clinical or laboratory evidence of infection.

ICD-9-CM Codes Covered by Medicare Program

Code

Descriptor

003.1

Salmonella septicemia.

038.0-038.9

Septicemia.

276.2

Acidosis.

276.4

Metabolic acidosis/alkalosis.

286.6

Defibrination syndrome/disseminated intravascular coagulation.

288.0

Agranulocytosis/neutropenia.

288.8

Other specified disease of white blood cells including leukemoid reaction/leukocytosis.

306.53

Psychogenic dysuria.

306.59

Other psychogenic genitourinary malfunction.

518.82

Other pulmonary insufficiency, not elsewhere classified.

570

Acute and subacute necrosis of liver.

580.0-580.9

Acute glomerulonephritis.

583.0-583.9

Nephritis and Nephropathy, not specified as acute or chronic.

584.5

Acute renal failure, with lesion of tubular necrosis.

584.9

Acute renal failure, unspecified.

585

Chronic renal failure.

586

Renal failure, unspecified.

590.00-590.9

Infections of kidney/pyelonephritis acute and chronic.

592.0-592.9

Calculus of kidney and ureter.

593.0-593.9

Other disorders of kidney and ureter (cyst, stricture, obstruction, reflux, etc.).

594.0-594.9

Calculus of lower urinary tract.

595.0-595.9

Cystitis.

597.0

Urethritis, not sexually transmitted and urethral syndrome.

597.80-597.89

Other urethritis.

598.00-598.01

Urethral stricture due to infection.

599.0

Urinary tract infection, site not specified.

599.7

Hematuria.

600

Hyperplasia of prostate.

601.0-601.9

Inflammatory diseases of prostate.

602.0-602.9

Other disorders of prostate (calculus, congestion, atrophy, etc.).

604.0-604.99

Orchitis and epididymitis.

608.0-608.9

Other disorders of male genital organs (seminal vesiculitis, spermatocele, etc.).

614.0-614.9

Inflammatory disease of ovary, fallopian tube, pelvic cellular tissue, and peritoneum.

615.0-615.9

Inflammatory disease of uterus, except cervix.

616.0

Cervicitis and endocervicitis.

616.10-616.11

Vaginitis and vulvovaginitis.

616.2-616.9

Other inflammatory conditions of cervix, vagina and vulva.

619.0-619.9

Fistula involving female genital tract.

625.6

Stress incontinence, female.

639.0

Genital tract and pelvic infection complicating abortion, ectopic or molar pregnancies.

639.5

Shock complicating abortion, ectopic or molar pregnancies.

646.60-.64

Infections of genitourinary tract in pregnancy.

670.00-.04

Major puerperal infection.

672.00-.04

Pyrexia of unknown origin during the puerperium.

724.5

Backache, unspecified.

780.2

Syncope and collapse.

780.6

Fever (Hyperthermia).

780.79

Other malaise and fatigue.

780.9

Other general symptoms (altered mental status, chills, generalized pains).

785.0

Tachycardia, unspecified.

785.50-.59

Shock without mention of trauma.

788.0-788.9

Symptoms involving urinary system. (renal colic, dysuria, retention of urine, incontinence of urine, frequency, polyuria, nocturia, oliguria, anuria, other abnormality of urination, urethral discharge, extravasation of urine, other symptoms of urinary system).

789.00-789.09

Abdominal pain.

789.60-789.69

Abdominal tenderness.

790.7

Bacteremia.

791.0-791.9

Nonspecific findings on examination of urine (proteinuria, chyluria, hemoglobinuria, myoglobinuria, biliuria, glycosuria, acetonuria, other cells and casts in urine, other nonspecific findings on examination of urine).

799.3

Debility, unspecified (only for declining functional status).

939.0

Foreign body in genitourinary tract, bladder and urethra.

939.3

Foreign body in genitourinary tract, penis.

V44.50-V44.6

Artificial cystostomy or other artificial opening of urinary tract status.

V55.5-V55.6

Attention to cystostomy or other artificial opening of urinary tract.

V58.69

Long-term (current) use of other medications.

V72.84

Pre-operative examination, unspecified.

Reasons for Denial

Note:

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

• Tests for screening purposes that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicitly authorized by statute. These include exams required by insurance companies, business establishments, government agencies, or other third parties.

• Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statute.

• Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician's office may result in denial.

• A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim.

• If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

• Tests that are not ordered by a treating physician or other qualified treating

nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary.

• Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.

• Tests that require an FDA approval or clearance will be denied as not reasonable and necessary if FDA approval or clearance has not been obtained, except for those having a Category B Investigational Device Exemption (IDE). Coverage of Category B IDE devices is left to contractor discretion. (See 60 FR 48425, Sept. 19, 1995).

ICD-9-CM Codes Denied..

Code

Descriptor

798.0-798.9

Sudden death, cause unknown.

V15.85

Exposure to potentially hazardous body fluids.

V16.1

Family history of malignant neoplasm, trachea, bronchus, and lung.

V16.2

Family history of malignant neoplasm, other respiratory and intrathoracic organs.

V16.4

Family history of malignant neoplasm, genital organs.

V16.5

Family history of malignant neoplasm, urinary organs.

V16.6

Family history of malignant neoplasm, leukemia.

V16.7

Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.

V16.8

Family history of malignant neoplasm, other specified malignant neoplasm.

V16.9

Family history of malignant neoplasm, unspecified malignant neoplasm.

V17.0-V17.8

Family history of certain chronic disabling diseases.

V18.0-V18.8

Family history of certain other specific conditions.

V19.0-V19.8

Family history of other conditions.

V20.0-V20.2

Health supervision of infant or child.

V28.0-V28.9

Antenatal screenings.

V50.0-V50.9

Elective surgery for purposes other than remedying health states.

V53.2

Fitting and adjustment of hearing aid.

V60.0-V60.9

Housing, household, and economic circumstances.

V62.0

Unemployment.

V62.1

Adverse effects of work environment.

V65.0

Healthy persons accompanying sick persons.

V65.1

Persons consulting on behalf of another person.

V68.0-V68.9

Encounters for administrative purposes.

V70.0-V70.9

General medical examinations.

V73.0-V73.99

Special screening examinations for viral and chlamydia diseases.

V74.0-V74.9

Special screening examinations for bacterial and spirochetal diseases.

V75.0-V75.9

Special screening examination for other infectious diseases.

V76.0

Special screening for malignant neoplasms, respiratory organs.

V76.3

Special screening for malignant neoplasms, bladder.

V76.42-V76.9

Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum).

V77.0-V77.9

Special screening for endocrine, nutrition, metabolic, and immunity disorders.

V78.0-V78.9

Special Screening for disorders of blood and blood-forming organs.

V79.0-V.79.9

Special screening for mental disorders.

V80.0-V80.3

Special screening for neurological, eye, and ear diseases.

V81.0-V81.6

Special screening for cardiovascular, respiratory, and genitourinary diseases.

V82.0-V82.9

Special screening for other conditions.

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

Code:    Descriptor

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

Sources of Information

Bone, RC, RA Bal, FB Cerra, and the ACCP/SCCM Consensus Conference Committee. 1992. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 101:1644-1655.

Clarridge, JE, JR Johnson, and MT Pezzlo. 1998 (in press). Cumitech 2B: Laboratory Diagnosis of Urinary Tract Infections. AS Weissfeld (coor. ed.); ASM Press, Washington, DC.

Kunin, CM. 1994. Urinary tract infections in females. Clin. Infect. Dis. 18:1-12.

Sodeman, TM. 1995. A practical strategy for diagnosis of urinary tract infections. Clin. Lab. Med. 15:235-250.

Stamm WE, and TM Hooton. 1993. Management of urinary tract infections in adults. N. Engl. J. Med. 329:1328-1334.

United States Preventive Services Task Force (1996). Guidelines for screening for asymptomatic bacteriuria.

Lachs MS, Nachamkin I, Edelstein PH et al. 1992. Spectrum bias in the evaluation of diagnostic tests: lessons from the rapid dipstick test for urinary tract infection. Ann. Int. Med. 117:135-140.

Coding Guidelines

1. Any claim for a test listed in “HCPCS Codes” above must be submitted with an ICD-9-CM diagnosis code or comparable narrative. Codes that describe symptoms and signs, as opposed to diagnoses, should be provided for reporting purposes when a diagnosis has not been established by the physician. (Based on Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 43).

2. Screening is the testing for disease or disease precursors so that early detection and treatment can be provided for those who test positive for the disease. Screening tests are performed when no specific sign, symptom, or diagnosis is present and the patient has not been exposed to a disease. The testing of a person to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptom is a diagnostic test, not a screening. In these cases, the sign or symptom should be used to explain the reason for the test. When the reason for performing a test is because the patient has had contact with, or exposure to, a communicable disease, the appropriate code from category V01, contact with or exposure to communicable diseases, should be assigned, not a screening code, but the test may still be considered screening and not covered by Medicare. For screening tests, the appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1996, pages 50 and 52).

3. A three-digit code is to be used only if it is not further subdivided. Where fourth-digit and/or fifth-digit subclassifications are provided, they must be assigned. A code is invalid if it has not been coded to the full number of digits required for that code. (From Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44).

4. Diagnoses documented as “probable,” “suspected,” “questionable,” “rule-out,” or “working diagnosis” should not be coded as

though they exist. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as signs, symptoms, abnormal test results, exposure to communicable disease or other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 45).

5. When a non-specific ICD-9 code is submitted, the underlying sign, symptom, or condition must be related to the indications for the test.

6. In the case of pre-operative examination (V72.84), the following codes may support medical necessity: 585, 586, 592.0-592.9, 594.0-594.9, 600, 602.0-602.9, 939.0, 939.3.

7. Specific coding guidelines:

a. Use CPT 87086 Culture, bacterial, urine; quantitative, colony count where a urine culture colony count is performed to determine the approximate number of bacteria present per milliliter of urine. The number of units of service is determined by the number of specimens.

b. Use CPT 87087 Culture, bacterial, urine; commercial kit where a commercial kit uses manufacturer defined media for isolation, presumptive identification, and quantitation of morphotypes present. The number of units of service is determined by the number of specimens.

c. Use CPT 87088 Culture, bacterial, urine; identification in addition to quantitative or commercial kit where identification of morphotypes recovered by quantitative culture or commercial kits and deemed to represent significant bacteriuria requires the use of additional testing, for example, biochemical test procedures on colonies. Identification based solely on visual observation of the primary media is usually not adequate to justify use of this code. The number of units of service is determined by the number of isolates.

d. Use CPT 87184 or 87186, Sensitivity studies where susceptibility testing of isolates deemed to be significant is performed concurrently with identification. The number of units of service is determined by the number of isolates. These codes are not exclusively used for urine cultures but are appropriate for isolates from other sources as well.

e. Appropriate combinations are as follows: CPT 87086 or 87087, 1 per specimen with 87088, 1 per isolate and 87184 or 87186 where appropriate.

f. Culture for other specific organism groups not ordinarily recovered by media used for aerobic urine culture may require use of additional CPT codes (for example, anaerobes from suprapubic samples).

g. Identification of isolates by non-routine, nonbiochemical methods may be coded appropriately (for example, immunologic identification of streptococci, nucleic acid techniques for identification of N. gonorrhoeae).

h. While infrequently used, sensitivity studies by methods other than CPT 87184 or 87186 are appropriate. CPT 87181, agar dilution method, each antibiotic or CPT 87188, macrotube dilution method, each antibiotic may be used. The number of units of service is the number of antibiotics multiplied by the number of unique isolates.

8. ICD-9-CM code 780.02, 780.9 or 799.3 should be used only in the situation of an elderly patient, immunocompromised patient or patient with neurologic disorder who presents without typical manifestations of a urinary tract infection but who presents with one of the following signs or symptoms, not otherwise explained by another co-existing condition: increasing debility; declining functional status; acute mental changes; changes in awareness; or hypothermia.

9. In cases of post renal-transplant urine culture used to detect clinically significant occult infection in patients on long term immunosuppressive therapy, use code V58.69.

Documentation Requirements

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

National Coverage Decision for:

Human Immunodeficiency Virus Testing (Prognosis including monitoring).

Other Names/Abbreviations:

HIV-1 or HIV-2 quantification or viral load.

Description

HIV quantification is achieved through the use of a number of different assays which measure the amount of circulating viral RNA. Assays vary both in methods used to detect viral RNA as well as in ability to detect viral levels at lower limits. However, all employ some type of nucleic acid amplification technique to enhance sensitivity, and results are expressed as the HIV copy number.

Quantification assays of HIV plasma RNA are used prognostically to assess relative risk for disease progression and predict time to death, as well as to assess efficacy of antiretroviral therapies over time.

HIV quantification is often performed together with CD4+ T cell counts which provide information on extent of HIV induced immune system damage already incurred.

HCPCS Codes

(alpha numeric, CPT

©

AMA)

Code

Descriptor

87536

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

87539

Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification.

Indications

1. A plasma HIV RNA baseline level may be medically necessary in any patient with confirmed HIV infection.

2. Regular periodic measurement of plasma HIV RNA levels may be medically necessary to determine risk for disease progression in an HIV-infected individual and to determine when to initiate or modify antiretroviral treatment regimens.

3. In clinical situations where the risk of HIV infection is significant and initiation of therapy is anticipated, a baseline HIV quantification may be performed. These situations include:

a. Persistence of borderline or equivocal serologic reactivity in an at-risk individual.

b. Signs and symptoms of acute retroviral syndrome characterized by fever, malaise, lymphadenopathy and rash in an at-risk individual.

Limitations

1. Viral quantification may be appropriate for prognostic use including baseline determination, periodic monitoring, and monitoring of response to therapy. Use as a diagnostic test method is not indicated.

2. Measurement of plasma HIV RNA levels should be performed at the time of establishment of an HIV infection diagnosis. For an accurate baseline, 2 specimens in a 2-week period are appropriate.

3. For prognosis including antiretroviral therapy monitoring, regular, periodic measurements are appropriate. The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of antiretroviral agents in adults and adolescents or pediatrics.

4. Because differences in absolute HIV copy number are known to occur using different assays, plasma HIV RNA levels should be measured by the same analytical method. A change in assay method may necessitate re-establishment of a baseline.

5. Nucleic acid quantification techniques are representative of rapidly emerging and evolving new technologies. As such, users are advised to remain current on FDA-approval status.

ICD-9-CM Codes Covered by Medicare Program

Code

Descriptor

042

Human immunodeficiency virus [HIV] disease.

079.53

Human immunodeficiency virus, type 2 [HIV-2].

647.60-.64

Other viral diseases complicating pregnancy (including HIV-I and II).

795.71

Nonspecific serologic evidence of human immunodeficiency virus [HIV].

V08

Asymptomatic human immunodeficiency virus [HIV] infection status.

Reasons for Denial

Note:

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

• Tests for screening purposes that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicitly authorized by statute. These include exams required by insurance companies, business establishments, government agencies, or other third parties.

• Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statute.

• Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician's office may result in denial.

• A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim.

• If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

• Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary.

• Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.

• Tests that require an FDA approval or clearance will be denied as not reasonable and necessary if FDA approval or clearance has not been obtained, except for those having a Category B Investigational Device Exemption (IDE). Coverage of Category B IDE devices is left to contractor discretion. (See 60 FR 48425, Sept. 19, 1995)

ICD-9-CM Codes Denied

Code

Descriptor

798.0-798.9

Sudden death, cause unknown.

V15.85

Exposure to potentially hazardous body fluids.

V16.1

Family history of malignant neoplasm, trachea, bronchus, and lung.

V16.2

Family history of malignant neoplasm, other respiratory and intrathoracic organs.

DV16.4

Family history of malignant neoplasm, genital organs.

V16.5

Family history of malignant neoplasm, urinary organs.

V16.6

Family history of malignant neoplasm, leukemia.

V16.7

Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.

V16.8

Family history of malignant neoplasm, other specified malignant neoplasm.

V16.9

Family history of malignant neoplasm, unspecified malignant neoplasm.

V17.0-V17.8

Family history of certain chronic disabling diseases.

V18.0-V18.8

Family history of certain other specific conditions.

V19.0-V19.8

Family history of other conditions.

V20.0-V20.2

Health supervision of infant or child.

V28.0-V28.9

Antenatal screenings.

V50.0-V50.9

Elective surgery for purposes other than remedying health states.

V53.2

Fitting and adjustment of hearing aid.

V60.0-V60.9

Housing, household, and economic circumstances.

V62.0

Unemployment.

V62.1

Adverse effects of work environment.

V65.0

Healthy persons accompanying sick persons.

V65.1

Persons consulting on behalf of another person.

V68.0-V68.9

Encounters for administrative purposes.

V70.0-V70.9

General medical examinations.

V73.0-V73.99

Special screening examinations for viral and chlamydia diseases.

V74.0-V74.9

Special screening examinations for bacterial and spirochetal diseases.

V75.0-V75.9

Special screening examination for other infectious diseases.

V76.0

Special screening for malignant neoplasms, respiratory organs.

V76.3

Special screening for malignant neoplasms, bladder.

V76.42-V76.9

Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).

V77.0-V77.9

Special screening for endocrine, nutrition, metabolic, and immunity disorders.

V78.0-V78.9

Special Screening for disorders of blood and blood-forming organs.

V79.0-V.79.9

Special screening for mental disorders.

V80.0-V80.3

Special screening for neurological, eye, and ear diseases.

V81.0-V81.6

Special screening for cardiovascular, respiratory, and genitourinary diseases.

V82.0-V82.9

Special screening for other conditions.

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

Code:   Description

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

Sources of Information

CDC. 1998. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR 47 (RR-5).

CDC. 1998. Guidelines for the use of antiretroviral agents in pediatric HIV infection. MMWR 47 (RR-4).

CDC. 1998. Public Health Service Task Force recommendations for the use of antiretroviral drugs in pregnant women infected with HIV-1 for maternal health and for reducing perinatal HIV-1 transmission in the United States. MMWR 47 (RR-2).

Carpenter, C.C., M.A. Fischi, S.M. Hammer, et . al. 1998. Antiretroviral therapy for HIV infection in 1998. Updated recommendations of the international AIDS society-USA panel. .A.M.A. 280:78-86.

Saag, M.S., M. Holodniy, D.R. Kuritzkes, et al. 1996. HIV viral load markers in clinical practice. Nature Medicine 2(6): 625-629.

Coding Guidelines

1. Any claim for a test listed in “HCPCS CODES” above must be submitted with an ICD-9-CM diagnosis code or comparable narrative. Codes that describe symptoms and signs, as opposed to diagnoses, should be

provided for reporting purposes when a diagnosis has not been established by the physician. (Based on Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 43.)

2. Screening is the testing for disease precursors so that early detection and treatment can be provided for those who test positive for the disease. Screening tests are performed when no specific sign, symptom, or diagnosis is present and the patient has not been exposed to a disease. The testing of a person to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptom is a diagnostic test, not a screening. In these cases, the sign or symptom should be used to explain the reason for the test. When the reason for performing a test is because the patient has had contact with, or exposure to, a communicable disease, the appropriate code from category V01, Contact with or exposure to communicable diseases, should be assigned, not a screening code, but the test may still be considered screening and not covered by Medicare. For screening tests, the appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1996, pages 50 and 52)

3. A three-digit code is to be used only if it is not further subdivided. Where fourth-digit and/or fifth-digit subclassifications are provided, they must be assigned. A code is invalid if it has not been coded to the full number of digits required for that code. (From Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)

4. Diagnoses documented as “probable,” “suspected,” “questionable,” “rule-out,” or “working diagnosis” should not be coded as though they exist. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as signs, symptoms, abnormal test results, exposure to communicable disease or other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 45.)

5. When a non-specific ICD-9 code is submitted, the underlying sign, symptom, or condition must be related to the indications for the test above.

6. Specific coding guidelines:

a. Temporary code G0100 has been superseded by code 87536 effective January 1, 1998.

b. CPT codes for quantification should not be used simultaneously with other nucleic acid detection codes for HIV-1 (that is, 87534, 87535) or HIV-2 (that is, 87537, 87538).

7. Codes 647.60-.64 should only be used for HIV infections complicating pregnancy.

Other Comments

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

Medicare National Coverage Decision For:

Human Immunodeficiency Virus Testing (Diagnosis).

Other Names/Abbreviations:

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

Description

Diagnosis of Human Immunodeficiency Virus (HIV) infection is primarily made through the use of serologic assays. These assays take one of two forms: antibody detection assays and specific HIV antigen (p24) procedures. The antibody assays are usually enzyme immunoassays (EIA) which are used to confirm exposure of an individual's immune system to specific viral antigens. These assays may be formatted to detect HIV-1, HIV-2, or HIV-1 and 2 simultaneously and to detect both IgM and IgG. When the initial EIA test is repeatedly positive or indeterminant, an alternative test is used to confirm the specificity of the antibodies to individual viral components. The most commonly used method is the Western Blot.

The HIV-1 core antigen (p24) test detects circulating viral antigen which may be found prior to the development of antibodies and may also be present in later stages of illness in the form of recurrent or persistent antigenemia. Its prognostic utility in HIV infection has been diminished as a result of development of sensitive viral RNA assays, and its primary use today is as a routine screening tool in potential blood donors.

In several unique situations, serologic testing alone may not reliably establish an HIV infection. This may occur because the antibody response (particularly the IgG response detected by Western Blot) has not yet developed (that is, acute retroviral syndrome), or is persistently equivocal because of inherent viral antigen variability. It is also an issue in perinatal HIV infection due to transplacental passage of maternal HIV antibody. In these situations, laboratory evidence of HIV in blood by culture, antigen assays, or proviral DNA or viral RNA assays, is required to establish a definitive determination of HIV infection.

HCPCS Codes

(Alpha numeric, CPT

©

AMA):

Code

Descriptor

86689

Qualitative or semiquantitative immunoassays performed by multiple step methods; HTLV or HIV antibody, confirmatory test (for example, Western Blot).

86701

Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1.

86702

Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-2.

86703

Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 and HIV-2, single assay.

87390

Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step; HIV-1.

87391

Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step; HIV-2.

87534

Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique.

87535

Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe technique HIV-1, amplified probe technique.

87537

Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, direct probe technique.

87538

Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, amplified probe technique.

Indications

Diagnostic testing to establish HIV infection may be indicated when there is a strong clinical suspicion supported by one or more of the following clinical findings:

1. The patient has a documented, otherwise unexplained, AIDS-defining or AIDS-associated opportunistic infection.

2. The patient has another documented sexually transmitted disease which identifies significant risk of exposure to HIV and the potential for an early or subclinical infection.

3. The patient has documented acute or chronic hepatitis B or C infection which identifies a significant risk of exposure to HIV and the potential for an early or subclinical infection.

4. The patient has a documented AIDS-defining or AIDS-associated neoplasm.

5. The patient has a documented AIDS-associated neurologic disorder or otherwise unexplained dementia.

6. The patient has another documented AIDS-defining clinical condition, or a history of other severe, recurrent, or persistent conditions which suggest an underlying immune deficiency (for example, cutaneous or mucosal disorders).

7. The patient has otherwise unexplained generalized signs and symptoms suggestive of a chronic process with an underlying immune deficiency (for example, fever, weight loss, malaise, fatigue, chronic diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of breath, or lymphadenopathy).

8. The patient has otherwise unexplained laboratory evidence of a chronic disease process with an underlying immune deficiency (for example, anemia, leukopenia,

pancytopenia, lymphopenia, or low CD4+ lymphocyte count).

9. The patient has signs and symptoms of acute retroviral syndrome with fever, malaise, lymphadenopathy, and skin rash.

10. The patient has documented exposure to blood or body fluids known to be capable of transmitting HIV (for example, needlesticks and other significant blood exposures) and antiviral therapy is initiated or anticipated to be initiated.

11. The patient is undergoing treatment for rape. (HIV testing is a part of the rape treatment protocol.)

For a comprehensive tabulation of AIDS-defining and AIDS associated conditions, refer to information source document #5.

Limitations

1. HIV antibody testing in the United States is usually performed using HIV-1 or HIV-

1/2

combination tests. HIV-2 testing is indicated if clinical circumstances suggest HIV-2 is likely (that is, compatible clinical findings and HIV-1 test negative). HIV-2 testing may also be indicated in areas of the country where there is greater prevalence of HIV-2 infections.

2. The Western Blot test should be performed only after documentation that the initial EIA tests are repeatedly positive or equivocal on a single sample.

3. The HIV antigen tests currently have no defined diagnostic usage.

4. Direct viral RNA detection may be performed in those situations where serologic testing does not establish a diagnosis but strong clinical suspicion persists (for example, acute retroviral syndrome, nonspecific serologic evidence of HIV, or perinatal HIV infection).

5. If initial serologic tests confirm an HIV infection, repeat testing is not indicated.

6. If initial serologic tests are HIV EIA negative and there is no indication for confirmation of infection by viral RNA detection, the interval prior to retesting is 3-6 months.

7. Testing for evidence of HIV infection using serologic methods may be medically appropriate in situations where there is a risk of exposure to HIV. However, in the absence of a documented AIDS defining or HIV associated disease, an HIV associated sign or symptom, or documented exposure to a known HIV-infected source, the testing is considered by Medicare to be screening and thus is not covered by Medicare (for example, history of multiple blood component transfusions, exposure to blood or body fluids not resulting in consideration of therapy, history of transplant, history of illicit drug use, multiple sexual partners, same-sex encounters, prostitution, or contact with prostitutes).

8. The CPT Editorial Panel has issued a number of codes for infectious agent detection by direct antigen or nucleic acid probe techniques that have not yet been developed or are only being used on an investigational basis. Laboratory providers are advised to remain current on FDA-approval status for these tests.

ICD-9-CM Codes Covered by Medicare Program

Code

Description

003.1

Salmonella septicemia.

007.2

Coccidiosis (Isoporiasis).

007.4

Cryptosporidiosis.

007.8

Other specified protozoal intestinal diseases.

010.00-010.96

Primary tuberculous infection.

011.00-011.96

Pulmonary tuberculosis.

012.00-012.86

Other respiratory tuberculosis.

013.00-013.96

Tuberculosis of meninges and central nervous system.

014.00-014.86

Tuberculosis of intestines, peritoneum and mesenteric glands.

015.00-015.96

Tuberculosis of bones and joints.

016.00-016.96

Tuberculosis of genitourinary system.

017.00-017.96

Tuberculosis of other organs.

018.00-018.96

Miliary tuberculosis.

027.0

Listeriosis.

031.0-031.9

Diseases due to other mycobacteria.

038.2

Pneumococcal septicemia.

038.43

Septicemia (Pseudomonas).

039.0-.9

Actinomycotic infections (includes Nocardia).

041.7

Pseudomonas infection.

042

HIV disease (Acute retroviral syndrome, AIDS-related complex).

046.3

Progressive multifocal leukoencephalopathy.

049.0-049.9

Other non-arthropod-borne viral diseases of central nervous system.

052.0-052.8

Chickenpox (with complication).

053.0-053.9

Herpes zoster.

054.0-054.9

Herpes simplex.

055.0-055.8

Measles (with complication).

070.20-070.23

Viral hepatitis B with hepatic coma.

070.30-070.33

Viral hepatitis B without mention of hepatic coma.

070.41

Acute or unspecified hepatitis C with hepatic coma.

070.42

Hepatitis delta without mention of active hepatitis B disease with hepatic coma.

070.44

Chronic hepatitis C with hepatic coma.

070.49

Other specified viral hepatitis with hepatic coma.

070.51

Acute or unspecified hepatitis C without hepatic coma.

070.52

Hepatitis delta without mention of active hepatitis B disease without hepatic coma.

070.54

Chronic hepatitis C without hepatic coma.

070.59

Other specified viral hepatitis without hepatic coma.

070.6

Unspecified viral hepatitis with hepatic coma.

070.9

Unspecified viral hepatitis without hepatic coma.

078.0

Molluscum contagiosum.

078.10-078.19

Viral warts.

078.3

Cat-scratch disease.

078.5

Cytomegaloviral disease.

078.88

Other specified diseases due to Chlamydiae.

079.50

Retrovirus unspecified.

079.51

HTLV-I.

079.52

HTLV-II.

079.53

HTLV-III.

079.59

Other specified Retrovirus.

079.88

Other specified chlamydial infection.

079.98

Unspecified chlamydial infection.

085.0-085.9

Leishmaniasis.

088.0

Bartonellosis.

090.0-090.9

Congenital syphilis.

091.0-091.9

Early syphilis symptomatic.

092.0-092.9

Early syphilis, latent.

093.0-093.9

Cardiovascular syphilis.

094.0-094.9

Neurosyphilis.

095.0-095.9

Other forms of late syphilis, with symptoms.

096

Late syphilis, latent.

097.0-097.9

Other and unspecified syphilis.

098.0-098.89

Gonococcal infections.

099.0

Chancroid.

099.1

Lymphogranuloma venereum.

099.2

Granuloma inguinale.

099.3

Reiter's disease.

099.40-099.49

Other nongonococcal urethritis.

099.50-099.59

Other venereal diseases due to Chlamydia trachomatis.

099.8

Other specified venereal disease.

099.9

Venereal disease unspecified.

110.1

Dermatophytosis of nail.

111.0

Pityriasis versicolor.

112.0-112.9

Candidiasis.

114.0-114.9

Coccidioidomycosis.

115.00-115.99

Histoplasmosis.

116.0-116.2

Blastomycotic infection.

117.3

Aspergillosis.

117.5

Cryptococcosis.

118

Opportunistic mycoses.

127.2

Strongyloidiasis.

130.0-130.9

Toxoplasmosis.

131.01

Trichomonal vulvovaginitis.

132.2

Phthirus pubis.

133.0

Scabies.

136.2

Specific infections by free living amebae.

136.3

Pneumocystosis.

136.8

Other specified infectious and parasitic disease (for example, microsporidiosis).

176.0-176.9

Kaposi's sarcoma.

180.0-180.9

Malignant neoplasm of cervix uteri.

200.20-200.28

Burkitt's tumor or lymphoma.

200.80-200.88

Lymphosarcoma, other named variants.

201.00-201.98

Hodgkin's disease.

280.0-280.9

Iron deficiency anemias.

285.9

Anemia, unspecified.

287.3

Primary thrombocytopenia.

288.0

Agranulocytosis.

288.8

Other specified disease of white blood cells.

294.8

Other specified organic brain syndromes (chronic).

310.1

Organic personality syndrome.

322.2

Chronic meningitis.

336.9

Unspecified disease of spinal cord.

348.3

Encephalopathy unspecified.

354.0-354.9

Mononeuritis of upper limbs and mononeuritis multiplex.

356.8

Other specified idiopathic peripheral neuropathy.

363.20

Chorioretinitis, unspecified.

425.4

Other primary cardiomyopathies.

473.0-473.9

Chronic sinusitis.

481

Pneumococcal pneumonia.

482.0-482.9

Other bacterial pneumonia.

484.1

Pneumonia in cytomegalic inclusion disease.

512.8

Other spontaneous pneumothorax.

516.8

Other specified alveolar and parietoalveolar pneumonopathies.

528.2

Oral aphthae.

528.6

Leukoplakia of oral mucosa.

530.2

Ulcer of esophagus.

583.9

Nephropathy with unspecified pathological lesion in kidney.

588.8

Other specified disorders resulting from impaired renal function.

647.60-.64

Other viral diseases complicating pregnancy (use for HIV I and II).

682.0-682.9

Other cellulitis and abscess.

690.10-690.18

Seborrheic dermatitis.

696.1

Other psoriasis.

698.3

Lichenification and lichen simplex chronicus.

704.8

Other specified diseases of hair and hair follicles.

706.0-706.9

Diseases of sebaceous glands.

780.6

Fever.

780.79

Other malaise and fatigue.

783.2

Abnormal loss of weight.

783.4

Lack of expected normal physiological development.

785.6

Enlargement of lymph nodes.

786.00

Respiratory abnormality, unspecified.

786.05

Shortness of breath.

786.2

Cough.

786.3

Hemoptysis.

786.4

Abnormal sputum.

787.91

Diarrhea.

795.71

Nonspecific serologic evidence of human immunodefiency virus.

799.4

Wasting disease.

V01.7

Contact with or exposure to communicable diseases, other viral diseases.

V71.5

Rape.

Reasons for Denial

Note:

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

• Tests for screening purposes that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicitly authorized by statute. These include exams required by insurance companies, business establishments, government agencies, or other third parties.

• Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statute.

• Failure to provide documentation of the medical necessity of tests may result in denial of claims. Such documentation may include notes documenting relevant signs, symptoms or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician's office may result in denial.

• A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim.

• If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

• Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary.

• Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.

• Tests that require an FDA approval or clearance will be denied as not reasonable and necessary if FDA approval or clearance has not been obtained, except for those having a Category B Investigational Device Exemption (IDE). Coverage of Category B IDE devices is left to contractor discretion. (See 60 FR 48425, Sept. 19, 1995)

ICD-9-CM Codes Denied

Code

Description

798.0-798.9

Sudden death, cause unknown.

V15.85

Exposure to potentially hazardous body fluids.

V16.1

Family history of malignant neoplasm, trachea, bronchus, and lung.

V16.2

Family history of malignant neoplasm, other respiratory and intrathoracic organs.

V16.4

Family history of malignant neoplasm, genital organs.

V16.5

Family history of malignant neoplasm, urinary organs.

V16.6

Family history of malignant neoplasm, leukemia.

V16.7

Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms.

V16.8

Family history of malignant neoplasm, other specified malignant neoplasm.

V16.9

Family history of malignant neoplasm, unspecified malignant neoplasm.

V17.0-V17.8

Family history of certain chronic disabling diseases.

V18.0-V18.8

Family history of certain other specific conditions.

V19.0-V19.8

Family history of other conditions.

V20.0-V20.2

Health supervision of infant or child.

V28.0-V28.9

Antenatal screenings.

V50.0-V50.9

Elective surgery for purposes other than remedying health states.

V53.2

Fitting and adjustment of hearing aid.

V60.0-V60.9

Housing, household, and economic circumstances.

V62.0

Unemployment.

V62.1

Adverse effects of work environment.

V65.0

Healthy persons accompanying sick persons.

V65.1

Persons consulting on behalf of another person.

V68.0-V68.9

Encounters for administrative purposes.

V70.0-V70.9

General medical examinations.

V73.0-V73.99

Special screening examinations for viral and chlamydia diseases.

V74.0-V74.9

Special screening examinations for bacterial and spirochetal diseases.

V75.0-V75.9

Special screening examination for other infectious diseases.

V76.0

Special screening for malignant neoplasms, respiratory organs.

V76.3

Special screening for malignant neoplasms, bladder.

V76.42-V76.9

Special screening for malignant neoplasms, (sites other than breast, cervix, and rectum).

V77.0-V77.9

Special screening for endocrine, nutrition, metabolic, and immunity disorders.

V78.0-V78.9

Special Screening for disorders of blood and blood-forming organs.

V79.0-V79.9

Special screening for mental disorders.

V80.0-V80.3

Special screening for neurological, eye, and ear diseases.

V81.0-V81.6

Special screening for cardiovascular, respiratory, and genitourinary diseases.

V82.0-V82.9

Special screening for other conditions.

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

Code:   Description

Any ICD-9-CM code not listed in neither of the ICD-9-CM sections above.

Sources of Information

CDC, 1993. Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 41 (No. RR17).

CDC, 1994. Revised classification system for human immunodeficiency virus infection in children less than 13 years of age.

CDC, 1998. Guidelines for treatment of sexually transmitted diseases. MMWR 47 (RR1):11-17.

Piatak, M., M.S. Saag, L.C. Yang,

et al.

1993. High levels of HIV-1 in plasma during all stages of infection determined by competitive PCR. Science 259:1749-1754.

Rhame, R.S. 1994. Acquired immunodeficiency syndrome, p. 628-652.

In Infectious Diseases;

P.D. Hoeprich, M.C. Jordan, and A.R. Ronald (J.B. Lippincott Co., Philadelphia).

Vasudevachari, M.D., R.T. Davey, Jr., J.A. Metcalf, and H.C. Lane. 1997. Principles and procedures of human immunodeficiency virus serodiagnosis.

In Manual of Clinical Laboratory Immunology

(Fifth ed.); N.R. Rose, E.C. de Macario, J.D. Folds, H.C. Lane, and R.M. Nakamura (ASM Press, Washington, DC).

Coding Guidelines

1. Any claim for a test listed in “HCPCS CODES” above must be submitted with an ICD-9-CM diagnosis code or comparable narrative. Codes that describe symptoms and signs, as opposed to diagnoses, should be provided for reporting purposes when a diagnosis has not been established by the physician. (Based on Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 43.)

2. Screening is the testing for disease or disease precursors so that early detection and treatment can be provided for those who test positive for the disease. Screening tests are performed when no specific sign, symptom, or diagnosis is present and the patient has not been exposed to a disease. The testing of a person to rule out or to confirm a suspected diagnosis because the patient has a sign and/or symptom is a diagnostic test, not a screening. In these cases, the sign or symptom should be used to explain the reason for the test. When the reason for performing a test is because the patient has had contact with, or exposure to, a communicable disease, the appropriate code from category V01, Contact with or exposure to communicable diseases, should be assigned, not a screening code, but the test may still be considered screening and not covered by Medicare. For screening tests, the appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or comparable narrative) should be used. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1996, pages 50 and 52.)

3. A three-digit code is to be used only if it is not further subdivided. Where fourth-digit and/or fifth-digit subclassifications are provided, they must be assigned. A code is invalid if it has not been coded to the full number of digits required for that code. (From Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)

4. Diagnoses documented as “probable,” “suspected,” “questionable,” “rule-out,” or “working diagnosis” should not be coded as though they exist. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as signs, symptoms, abnormal test results, exposure to communicable disease or other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 45.)

5. When a non-specific ICD-9 code is submitted, the underlying sign, symptom, or condition must be related to the indications for the test above.

6. Specific coding guidelines:

a. CPT 86701 or 86703 is performed initially. CPT 86702 is performed when 86701 is negative and clinical suspicion of HIV-2 exists.

b. CPT 86689 is performed only on samples repeatedly positive by 86701, 86702, or 86703.

c. CPT 87534 or 87535 is used to detect HIV-1 RNA where indicated. CPT 87537 or 87538 is used to detect HIV-2 RNA where indicated.

Documentation Requirements

Appropriate HCPCS/CPT codes must be used as described.

Medicare National Coverage Decision:

Blood Counts.

Other Names/Abbreviations:

CBC.

Description

Blood counts are used to evaluate and diagnose diseases relating to abnormalities of the blood or bone marrow. These include primary disorders such as anemia, leukemia, polycythemia, thrombocytosis and thrombocytopenia. Many other conditions secondarily affect the blood or bone marrow, including reaction to inflammation and infections, coagulopathies, neoplasms and exposure to toxic substances. Many treatments and therapies affect the blood or bone marrow, and blood counts may be used to monitor treatment effects.

The complete blood count (CBC) includes a hemogram and differential white blood count (WBC). The hemogram includes enumeration of red blood cells, white blood cells, and platelets, as well as the determination of hemoglobin, hematocrit, and indices.

The symptoms of hematological disorders are often nonspecific, and are commonly encountered in patients who may or may not prove to have a disorder of the blood or bone marrow. Furthermore, many medical conditions that are not primarily due to abnormalities of blood or bone marrow may have hematological manifestations that result from the disease or its treatment. As a result, the CBC is one of the most commonly indicated laboratory tests.

In patients with possible hematological abnormalities, it may be necessary to determine the hemoglobin and hematocrit, to calcu

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