Percutaneous Image-Guided Breast Biopsy

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Contractor's Policy Number

03-09

Contractor's Name

CareFirst of Maryland Inc., Medicare Part A

Contractor Number

00190

Contractor Type

Fiscal Intermediary

LMRP Title

Percutaneous Image-Guided Breast Biopsy

AMA CPT Copyright Statement

CMS National Coverage Policy

National Coverage Determination (NCD)
Coverage Issues Manual §50-59
Establishment of national policy supersedes all previous contractor policy statements, including Local Medical Policy coverage guidelines.
Title XVIII of the Social Security Act, section 1862 (a) (7). This section excludes routine physical examinations.
Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

Primary Geographic Jurisdiction

Maryland

Washington, DC

Secondary Geographic Jurisdiction

Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, Washington state, and Wyoming

CMS Region

Region III

CMS Consortium

Northeast

Original Policy Effective Date

09/29/2003

Original Policy Ending Date

Revision Effective Date

Revision Ending Date

LMRP Description

Percutaneous image-guided breast biopsy is a method of obtaining a breast biopsy through a percutaneous incision by employing image guidance systems. Percutaneous image-guided breast biopsy utilizes ultrasound or stereotactic guidance for needle insertion in a breast lesion that is otherwise located only by an open procedure. This particular type of needle biopsy is chosen according to the characteristics of the lesion.

Indications and Limitations of Coverage and/or Medical Necessity

The Breast Imaging Reporting and Data System (or BIRADS system) employed by the American College of Radiology provides a standardized lexicon with which radiologists may report their interpretation of a mammogram. The BIRADS grading of mammograms is as follows: Grade I-Negative, Grade II-Benign finding, Grade III-Probably benign, Grade IV-Suspicious abnormality, and Grade V-Abnormality.

Nonpalpable Breast Lesions

Effective January 1, 2003, Medicare covers percutaneous image-guided breast biopsy using stereotactic or ultrasound imaging for a radiographic abnormality that is nonpalpable and is graded as a BIRADS III (probably benign), IV (suspicious abnormality), or V (abnormality).

Palpable Breast Lesions

Effective January 1, 2003, Medicare covers percutaneous image guided breast biopsy using stereotactic or ultrasound imaging for palpable lesions that are difficult to biopsy using palpation alone.

CPT/HCPCS Section & Benefit Category

Surgery/Radiology

Ambulatory Surgical Center Facility Services

Outpatient Hospital Services Incident to a Physician's Service

Type of Bill Code

13X, 14X

Revenue Codes

30X, 31X

36X, 49X

32X, 33X, 34X, 35X, , 40X, 61X

320 (Use for hospitals not subject to OPPS)

CPT/HCPCS Codes

The AMA and CMS require the use of short descriptors for policies published on the Web. Refer to the CPT book for the long description of the following codes:

10022	©	Fine needle asp
19100	©	Biopsy of breast
19101	©	Biopsy of breast
19102	©	Biopsy of breast
19103	©	Biopsy of breast
76095	©	Stereotactic localization
76096	©	Mammographic guidance
76360	©	Computed tomography
76393	©	Magnetic resonance
76942	©	Ultrasonic guidance
88170	©	Fine needle asp

Not Otherwise Classified (NOC)

ICD-9 Codes that Support Medical Necessity

ICD-9-CM code listings may cover a range and include truncated codes. It is the provider’s responsibility to avoid truncated codes by selecting a code(s) carried out to the highest level of specificity and selected from the ICD-9-CM book appropriate to the year in which the claim is submitted.

It is not enough to link the procedure code to a correct, payable ICD-9-CM code. The diagnosis or clinical suspicion must be present for the procedure to be paid.

Medicare is establishing the following limited coverage:

Covered for:

611.72		Lump or mass in breast
793.80		Abnormal mammogram, unspecified
793.81		Mammographic microcalcification
793.89		Other abnormal findings on radiological examination of breast

Diagnoses that Support Medical Necessity

As listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

ICD-9 Codes that DO NOT Support Medical Necessity

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Diagnoses that DO NOT Support Medical Necessity

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Reasons for Denial

All other indications not listed in the "Indications and Limitations of Coverage" section of this policy,
A claim submitted without a valid ICD-9-CM code will be returned as an incomplete claim under 1833(e),
The service is for screening purposes,
The service is not medically necessary,
The medical record does not verify that the service described by the HCPCS code was provided, and;
The service does not follow the guidelines of this policy.

Non-covered ICD-9 Codes

Any diagnosis codes not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy

Non-covered Diagnoses

Conditions not listed in the "ICD-9 Codes that Support Medical Necessity" section of this policy.

Coding Guidelines

To report this service, use the appropriate HCPCS code(s).
Use codes 76095, 76096, 76360, 76393, or 76942 for imaging guidance performed in conjunction with 19102 or 19103.
Units are based on the number of lesions that are biopsied and not on the number of passes of the needle or sampling device into a single lesion. Regardless of the number of samples taken, the procedure should be coded per lesion.
All of the coverage criteria must be met before this service can be reimbursed by Medicare.
Diagnosis (es) must be present on any claim submitted, and be coded to the highest level of specificity.
The diagnosis codes(s) must be representative of the patient's condition.

Documentation Requirements

Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and available to Medicare upon request.
Each claim must be submitted with ICD-9-CM codes that reflect the condition of the patient and indicate the reason(s) for which the service was performed.
Documentation must support the medical necessity as outlined in the "Indications and Limitations" section of the policy.
When the procedure involves more than one lesion in the same breast, documentation in the medical record must indicate that the separate lesions are independent of each other, and that each biopsy is medically necessary.

Utilization Guidelines

Medicare will monitor the utilization of this procedure through the Medical Review process.

Other Comments

This policy was developed based on the National Coverage Determination (NCD) to expand the NCD to include appropriate ICD-9 codes, as they were not a part of the national determination.

Financial Responsibility:

Provider Liable

The provider of the service or the ordering physician must have notified the patient in writing, prior to the service, and obtain a signature verifying the Advance Beneficiary Notice (ABN). Without prior notice, services denied as not medically necessary cannot be billed to the beneficiary and the provider is liable.

Beneficiary Liable

If there is clear evidence that the beneficiary was issued and signed an Advanced Beneficiary Notice (ABN) prior to the service, the liability rests with the beneficiary. Claims for dates of service prior to January 1, 2003 should contain the condition code 20 and occurrence code 32, with the date to signify that an ABN was issued to the beneficiary. Absence of these codes will result in a provider liable determination.

Claims for dates of service beginning January 1, 2003 should contain the occurrence code 32 with the date to signify that an ABN was issued to the beneficiary. Absence of this code will result in a provider liable determination.

Reference: PM AB-02-168, CR 2415

Sources of Information and Basis for Decision

Empire Medicare Services LMRP
Program Memorandum AB-03-042, CR 2575
Coverage Issues Manual §50-59

Advisory Committee Notes

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups , which includes representatives from the appropriate specialty(ies).

Advisory Committee Meeting Date:

Start Date of Comment Period

06/17/2003

End Date of Comment Period

08/01/2003

Start Date of Notice Period

08/13/2003

Revision History

Number	Date	Change

THIS BULLETIN SHOULD BE SHARED WITH ALL HEALTH CARE PRACTITIONERS AND MANAGERIAL MEMBERS OF THE PROVIDER/SUPPLIER STAFF. BULLETINS ISSUED AFTER OCTOBER 1, 1999 ARE AVAILABLE FROM OUR WEBSITE AT www.marylandmedicare.com

Italicized and or quoted material is excerpted from the American Medical Association Current Procedural Terminology CPT codes, descriptions and other data only are copyrighted 1999 American Medical Association (or such other publication of CPT). All rights reserved. Applicable FARS/DFARS apply.