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Digital Breast Tomosynthesis (DBT) (Also Known As Three-Dimensional [3-D] Mammography)

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Digital Breast Tomosynthesis (DBT) (Also Known As Three-Dimensional [3-D] Mammography) Clinical Medical Policy Department Clinical Affairs Division Digital Breast Tomosynthesis (DBT) (also known as Three-Dimensional [3-D] Mammography) [For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr. go to “Comunicados a Proveedores”, and click “Cartas Circulares”.] Medical Policy: MP-RAD-01-13 Original Effective Date: August 15, 2013 Revised: December 24, 2020 Next Revision: December, 2021 Related Medical Policies: . Non-Digital & Digital Mammography (i.e. Screening & Diagnostic) (MP-RAD-03-10); & . 3D Interpretation and Reporting of Imaging Studies (MP-RAD-02-13). This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member’s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION Digital Breast Tomosynthesis (DBT), also known as 3-D Mammography, is a modification of digital mammography based on Full-Field Digital Mammography (FFDM), which uses a moving & low dose x-ray source and a digital detector at different angles. For DBT, the breast is positioned and compressed in, the same way as it would be for a traditional digital mammogram, but the x-ray tube moves in a circular arc around the breast. The DBT system can acquire 2D and 3D images separately, or combined in a single compression. A three-dimensional (3-D) volume of data is acquired and reconstructed using computer algorithms (i.e., software) to generate thin sections of images. As a modification of digital mammography, DBT has all the advantages of a standard digital mammogram. In addition, thin slice reconstruction improves the delineation of a lesion in the slice by eliminating overlap from surrounding structures. The examination has a slightly longer exposure time of 10 seconds per acquisition compared to standard digital mammography, which could increase the radiation dose per acquisition and increase the risk of motion artifacts. In spite of the radiation exposure, DBT has been approved by the U. S. Food & Drug Administration (FDA) for routine clinical use as an adjunct to standard mammography. In the screening setting, DBT helps to decrease recall rates by delineating true lesions from spurious lesions caused by overlapping structures seen on routine mammography. In the diagnostic setting, DBT improves lesion characterization, resulting in fewer biopsies and fewer false-positive biopsies while increasing rates of cancer detection. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 1 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 1 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS I. For the Commercial Line of Business (LOB): Medical Card System, Inc., (MCS) considers the use of Digital Breast Tomosynthesis (DBT) (i.e., 3-D Mammography) as medically necessary, Only in the context of Diagnostic Mammography (i.e., HCPCS Code G0279) as an add-on technology to standard digital mammography, when Criteria A plus B are met: A. Patient must meet All of the following requirements: 1. The patient must be under the care of the physician (or qualified non-physician practitioner) who orders the procedure; and 2. A physician (or qualified non-physician practitioner) referral is required for diagnostic mammography; and 3. The order should specify the diagnosis prompting the referral for a diagnostic mammogram; and 4. Services must be furnished by a facility that is certified by the Food & Drug Administration (FDA). Please refer to: FDA’s Database for Certified Mammography Facilities. B. Diagnostic Digital Breast Tomosynthesis (DBT) (i.e., 3-D Mammography) is medically covered for Any of the following indications: 1. There are signs and/or symptoms suggestive of malignancy (mass, some types of spontaneous nipple discharge or skin changes). 2. There are possible radiographic abnormalities detected on screening mammography. 3. There is short interval follow-up (less than one year) necessary for unresolved clinical/radiographic concerns. 4. Follow-up of established history of a malignancy is necessary. 5. Diagnostic breast evaluation may be indicated in cases of a personal history of malignancy and in cases of benign biopsy-proven breast disease. These diagnoses should not, however, routinely warrant a diagnostic mammography. 6. A breast implant does not necessarily imply that a mammogram is diagnostic in nature. Although additional views may be needed, these additional views do not necessarily constitute a diagnostic mammogram, unless there are specific findings that require investigation. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 2 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 2 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division 7. A Diagnostic DBT (i.e., 3-D mammography) may be furnished to a man who shows Any of the following: a. Signs and symptoms of breast disease; or b. A personal history of breast cancer; or c. A personal history of biopsy-proven benign breast disease, and includes a physician’s interpretation of the results of the procedure. Limitation for DBT (i.e., 3-D Mammography) for the Commercial LOB Only: 1. Medical Card System, Inc., (MCS) does Not cover Digital Breast Tomosynthesis (DBT) (i.e., 3- D Mammography) in the context of Screening Mammography (i.e., CPT® Code 77067). II. For the Classicare (Advantage) Line of Business (LOB): Medical Card System, Inc., (MCS) considers the use of Digital Breast Tomosynthesis (DBT) (i.e., 3-D Mammography) as medically necessary, for Both Screening (i.e., CPT® Code +77063) and Diagnostic Mammography (i.e., HCPCS Code G0279) as an adjunct to standard mammography, under the criteria established in Medicare under the Following reference: National Coverage Determination (NCD) for Mammograms (220.4). Please refer to the aforementioned NCD for further details. GENERAL LIMITATIONS FOR BOTH THE COMMERCIAL & CLASSICARE (ADVANTAGE) LOB 1. Medical Card System, Inc., (MCS) covers diagnostic mammography as often as medically necessary, defined by both the Indications and Limitations Sections. 2. Diagnostic mammography should be performed under the direct, on-site supervision of an interpreting physician qualified in mammography. 3. Medical Card System, Inc. (MCS) establishes the following Documentation Requirements for Diagnostic Mammography, in regards to the patient’s medical record and the process of claim submission, which must be available upon request: a. Documentation supporting the medical necessity, of a diagnostic mammogram, such as ICD-10-CM diagnosis codes, progress notes, etc., must be submitted with each claim. Claims submitted without such evidence will be denied as not medically necessary. b. A clear, clinical indication for the diagnostic mammogram must be documented in the medical record as well as in the referral order. This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 3 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 3 All Rights Reserved® Clinical Medical Policy Department Clinical Affairs Division c. When a diagnostic mammogram is ordered, the medical records must clearly support that the patient is under the care of the referring physician or qualified non- physician practitioner. d. The medical record must include a formal written report describing all the views completed. The formal written report must include the reason for the test, a description of the test, the interpretation and results of the test, and the name of the physician or qualified non-physician practitioner to whom the report is being sent. e. If the examination began as a screening mammogram and additional films were ordered based on abnormal results, the specific abnormality must be documented in the record, and the GG modifier must be documented on the claim line with the procedure code for a diagnostic mammogram. f. These services describe in this Medical Policy would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to medical review. CODING INFORMATION CPT® Code Covered for the Classicare (Advantage) LOB Only, for DBT (3-D) Screening Mammography (List may not be all inclusive) CPT® Codes Description +77063 Screening digital breast tomosynthesis, bilateral (list separately in addition to code for primary procedure) Current Procedural Terminology (CPT®) 2020 American
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