National Coverage Analysis (NCA) Tracking Sheet

Breast Biopsy (Percutaneous Image Guided) for Palpable Lesions

CAG-00074N

Issue

Percutaneous image guided breast biopsy is sometimes used as an alternative to needle localization and open excisional biopsy to evaluate palpable mammographically detected breast lesions.

The Centers for Medicare and Medicaid Services (CMS) recently issued a national coverage decision for nonpalpable lesions. This request looks at extending national coverage to palpable lesions.

Benefit Category

Ambulatory Surgical Center Facility Services
Inpatient Hospital Services
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Ethicon Endo-Surgery N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/12/2000
Expected NCA Completion Date
03/01/2002
Public Comment Period
11/13/2000 - 12/13/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
04/12/2002

Contacts

Lead Analysts
Sharon Hippler
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

December 29, 2000

Currently awaiting position statements from professional associations. Will extend current due date to end of month.

January 11, 2000

CMS received an official position statement from the American College of Radiology.

January 30, 2000

CMS received an official position statement from the American Society of Breast Surgeons.

January 31, 2000

Currently awaiting position statements from other professional associations. Will extend current due date to February 28, 2001.

March 27, 2001

Met with Ethicon Endosurgery. Several new articles submitted for review. Will extend current due date to May 14, 2001.

May 13, 2001

Given the complexity of the issue, we are extending the due date to June 30 to get additional input.

August 13, 2001

Need additional time to review the evidence submitted to determine the precise role of this imaging technique for palpable lesions. Will extend due date to September 30.

October 26, 2001

Need further additional time to review the evidence submitted to determine the precise role of this imaging technique for palpable lesions. Will extend due date to December 1.

December 6, 2001

Need further additional time to review. We will extend the due date to February 1, 2002.

February 4, 2002

Need additional time to complete the review. Due date will be extended to March 1, 2002.

April 12, 2002

CMS issues decision memorandum stating intent to cover the use of image-guided breast biopsy for palpable lesions that are difficult to biopsy using palpation.

September 2002

Claims processing instructions issued and NCD updated.