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 Medical Association: Chicago, IL.

Note1: CPT® Code +77063 is Not covered for the Commercial LOB.

Note2: Do not report CPT® Code +77063 in conjunction with CPT® Codes 76376, 76377, 77065 and 77066 (AMA CPT®, 2020).

Note3: Use CPT® Code +77063 in conjunction with CPT® Code 77067.

CPT® Code Covered for the Commercial LOB Only, for DBT (3-D) Diagnostic Mammography (List may not be all inclusive) CPT® Codes Description 77065 Diagnostic mammography, including computer aided detection (CAD) when performed ; unilateral 77066 Diagnostic mammography, including computer aided detection (CAD) when performed ; bilateral 77067 Screening mammography, bilateral (2-view study of each breast), including computer- aided detection (CAD) when performed

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 4 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 4 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division Current Procedural Terminology (CPT®) 2020 American Medical Association: Chicago, IL.

HCPCS Codes Covered Classicare (Advantage) LOB for DBT (3-D) Diagnostic Mammography (List may not be all inclusive) HCPCS Codes Description G0279 Diagnostic digital breast tomosynthesis, unilateral or bilateral 2020 HCPCS LEVEL II Professional Edition® (American Medical Association). Note6: For G0279, List separately in addition to 77065 or 77066.

HCPCS Modifiers (List may not be all inclusive) Modifiers DESCRIPTION TC Technical component 26 Professional component GH Diagnostic mammogram converted from screening mammogram on same day GG Performance and payment of a screening mammogram and diagnostic mammogram on the same patient, same day 2020 HCPCS LEVEL II Professional Edition® (American Medical Association).

Note4: For a screening mammography and a diagnostic mammography that are performed on the same date of service, for the same patient, please append modifier - GG to the diagnostic mammography procedure code (e.g., 77066 or 77065). Both the screening mammography and the diagnostic mammography procedure codes should be reported on the same claim.

ICD-10 Codes (List may not be all inclusive) ICD-10-Codes DESCRIPTION C43.52 Malignant melanoma of skin of breast C43.59 Malignant melanoma of other part of trunk C44.501 Unspecified malignant neoplasm of skin of breast C44.509 Unspecified malignant neoplasm of skin of other part of trunk C44.511 Basal cell carcinoma of skin of breast C44.519 Basal cell carcinoma of skin of other part of trunk C44.521 Squamous cell carcinoma of skin of breast C44.529 Squamous cell carcinoma of skin of other part of trunk C44.591 Other specified malignant neoplasm of skin of breast C44.599 Other specified malignant neoplasm of skin of other part of trunk C45.9 Mesothelioma, unspecified C50.011 Malignant neoplasm of nipple and areola, right female breast C50.012 Malignant neoplasm of nipple and areola, left female breast C50.021 Malignant neoplasm of nipple and areola, right male breast C50.022 Malignant neoplasm of nipple and areola, left male breast C50.111 Malignant neoplasm of central portion of right female breast C50.112 Malignant neoplasm of central portion of left female breast C50.121 Malignant neoplasm of central portion of right male breast C50.122 Malignant neoplasm of central portion of left male breast C50.211 Malignant neoplasm of upper-inner quadrant of right female breast

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 5 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 5 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division C50.212 Malignant neoplasm of upper-inner quadrant of left female breast C50.221 Malignant neoplasm of upper-inner quadrant of right male breast C50.222 Malignant neoplasm of upper-inner quadrant of left male breast C50.311 Malignant neoplasm of lower-inner quadrant of right female breast C50.312 Malignant neoplasm of lower-inner quadrant of left female breast C50.321 Malignant neoplasm of lower-inner quadrant of right male breast C50.322 Malignant neoplasm of lower-inner quadrant of left male breast C50.411 Malignant neoplasm of upper-outer quadrant of right female breast C50.412 Malignant neoplasm of upper-outer quadrant of left female breast C50.421 Malignant neoplasm of upper-outer quadrant of right male breast C50.422 Malignant neoplasm of upper-outer quadrant of left male breast C50.511 Malignant neoplasm of lower-outer quadrant of right female breast C50.512 Malignant neoplasm of lower-outer quadrant of left female breast C50.521 Malignant neoplasm of lower-outer quadrant of right male breast C50.522 Malignant neoplasm of lower-outer quadrant of left male breast C50.611 Malignant neoplasm of axillary tail of right female breast C50.612 Malignant neoplasm of axillary tail of left female breast C50.621 Malignant neoplasm of axillary tail of right male breast C50.622 Malignant neoplasm of axillary tail of left male breast C50.811 Malignant neoplasm of overlapping sites of right female breast C50.812 Malignant neoplasm of overlapping sites of left female breast C50.821 Malignant neoplasm of overlapping sites of right male breast C50.822 Malignant neoplasm of overlapping sites of left male breast C50.911 Malignant neoplasm of unspecified site of right female breast C50.912 Malignant neoplasm of unspecified site of left female breast C50.921 Malignant neoplasm of unspecified site of right male breast C50.922 Malignant neoplasm of unspecified site of left male breast C56.1 Malignant neoplasm of right ovary C56.2 Malignant neoplasm of left ovary C77.3 Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes C78.01 Secondary malignant neoplasm of right lung C78.02 Secondary malignant neoplasm of left lung C78.1 Secondary malignant neoplasm of mediastinum C78.2 Secondary malignant neoplasm of pleura C78.7 Secondary malignant neoplasm of liver and intrahepatic bile duct C79.2 Secondary malignant neoplasm of skin C79.31 Secondary malignant neoplasm of brain C79.32 Secondary malignant neoplasm of cerebral meninges C79.40 Secondary malignant neoplasm of unspecified part of nervous system C79.49 Secondary malignant neoplasm of other parts of nervous system C79.51 Secondary malignant neoplasm of bone C79.52 Secondary malignant neoplasm of bone marrow C79.61 Secondary malignant neoplasm of right ovary

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 6 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 6 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division C79.62 Secondary malignant neoplasm of left ovary C79.81 Secondary malignant neoplasm of breast C80.0 Disseminated malignant neoplasm, unspecified C80.1 Malignant (primary) neoplasm, unspecified D03.52 Melanoma in situ of breast (skin) (soft tissue) D03.59 Melanoma in situ of other part of trunk D04.5 Carcinoma in situ of skin of trunk D05.01 Lobular carcinoma in situ of right breast D05.02 Lobular carcinoma in situ of left breast D05.11 Intraductal carcinoma in situ of right breast D05.12 Intraductal carcinoma in situ of left breast D05.81 Other specified type of carcinoma in situ of right breast D05.82 Other specified type of carcinoma in situ of left breast D05.91 Unspecified type of carcinoma in situ of right breast D05.92 Unspecified type of carcinoma in situ of left breast D22.5 Melanocytic nevi of trunk D23.5 Other benign neoplasm of skin of trunk D24.1 Benign neoplasm of right breast D24.2 Benign neoplasm of left breast D48.5 Neoplasm of uncertain behavior of skin D48.61 Neoplasm of uncertain behavior of right breast D48.62 Neoplasm of uncertain behavior of left breast D49.1 Neoplasm of unspecified behavior of respiratory system D49.2 Neoplasm of unspecified behavior of bone, soft tissue, and skin D49.3 Neoplasm of unspecified behavior of breast D49.6 Neoplasm of unspecified behavior of brain D49.7 Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system I80.8 Phlebitis and thrombophlebitis of other sites M70.80 Other soft tissue disorders related to use, overuse and pressure of unspecified site M70.88 Other soft tissue disorders related to use, overuse and pressure other site M70.89 Other soft tissue disorders related to use, overuse and pressure multiple sites M70.90 Unspecified soft tissue disorder related to use, overuse and pressure of unspecified site M70.98 Unspecified soft tissue disorder related to use, overuse and pressure other M70.99 Unspecified soft tissue disorder related to use, overuse and pressure multiple sites M79.5 Residual foreign body in soft tissue M79.81 Nontraumatic hematoma of soft tissue M79.89 Other specified soft tissue disorders M79.9 Soft tissue disorder, unspecified N60.01 Solitary cyst of right breast N60.02 Solitary cyst of left breast N60.11 Diffuse cystic mastopathy of right breast N60.12 Diffuse cystic mastopathy of left breast N60.21 Fibroadenosis of right breast

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 7 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 7 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division N60.22 Fibroadenosis of left breast N60.31 Fibrosclerosis of right breast N60.32 Fibrosclerosis of left breast N60.41 Mammary duct ectasia of right breast N60.42 Mammary duct ectasia of left breast N60.81 Other benign mammary dysplasias of right breast N60.82 Other benign mammary dysplasias of left breast N60.91 Unspecified benign mammary dysplasia of right breast N60.92 Unspecified benign mammary dysplasia of left breast N61.0 Mastitis without abscess N61.1 Abscess of the Breast and Nipple N62 Hypertrophy of breast N63.10 Unspecified lump in the right breast, unspecified quadrant N63.11 Unspecified lump in the right breast, upper outer quadrant N63.12 Unspecified lump in the right breast, upper inner quadrant N63.13 Unspecified lump in the right breast, lower outer quadrant N63.14 Unspecified lump in the right breast, lower inner quadrant N63.20 Unspecified lump in the left breast, unspecified quadrant N63.21 Unspecified lump in the left breast, upper outer quadrant N63.22 Unspecified lump in the left breast, upper inner quadrant N63.23 Unspecified lump in the left breast, lower outer quadrant N63.24 Unspecified lump in the left breast, lower inner quadrant N63.31 Unspecified lump in axillary tail of the right breast N63.32 Unspecified lump in axillary tail of the left breast N63.41 Unspecified lump in right breast, subareolar N63.42 Unspecified lump in left breast, subareolar N64.0 Fissure and fistula of nipple N64.1 Fat necrosis of breast N64.2 Atrophy of breast N64.3 Galactorrhea not associated with childbirth N64.4 Mastodynia N64.51 Induration of breast N64.52 Nipple discharge N64.53 Retraction of nipple N64.59 Other signs and symptoms in breast N64.81 Ptosis of breast N64.82 Hypoplasia of breast N64.89 Other specified disorders of breast N64.9 Disorder of breast, unspecified N65.0 Deformity of reconstructed breast N65.1 Disproportion of reconstructed breast R59.0 Localized enlarged lymph nodes R59.1 Generalized enlarged lymph nodes R59.9 Enlarged lymph nodes, unspecified

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 8 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 8 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division R92.0 Mammographic microcalcification found on diagnostic imaging of breast R92.1 Mammographic calcification found on diagnostic imaging of breast R92.2 Inconclusive mammogram R92.8 Other abnormal and inconclusive findings on diagnostic imaging of breast R93.9 Diagnostic imaging inconclusive due to excess body fat of patient S20.01XA Contusion of right breast, initial encounter S20.02XA Contusion of left breast, initial encounter S21.001A Unspecified open wound of right breast, initial encounter S21.002A Unspecified open wound of left breast, initial encounter S21.011A Laceration without foreign body of right breast, initial encounter S21.012A Laceration without foreign body of left breast, initial encounter S21.021A Laceration with foreign body of right breast, initial encounter S21.022A Laceration with foreign body of left breast, initial encounter S21.031A Puncture wound without foreign body of right breast, initial encounter S21.032A Puncture wound without foreign body of left breast, initial encounter S21.041A Puncture wound with foreign body of right breast, initial encounter S21.042A Puncture wound with foreign body of left breast, initial encounter S21.051A Open bite of right breast, initial encounter S21.052A Open bite of left breast, initial encounter S28.211A Complete traumatic amputation of right breast, initial encounter S28.212A Complete traumatic amputation of left breast, initial encounter S28.221A Partial traumatic amputation of right breast, initial encounter S28.222A Partial traumatic amputation of left breast, initial encounter S29.001A Unspecified injury of muscle and tendon of front wall of thorax, initial encounter S29.009A Unspecified injury of muscle and tendon of unspecified wall of thorax, initial encounter S29.091A Other injury of muscle and tendon of front wall of thorax, initial encounter S29.099A Other injury of muscle and tendon of unspecified wall of thorax, initial encounter S29.8XXA Other specified injuries of thorax, initial encounter S29.9XXA Unspecified injury of thorax, initial encounter S39.001A Unspecified injury of muscle, fascia and tendon of abdomen, initial encounter S39.091A Other injury of muscle, fascia and tendon of abdomen, initial encounter S39.81XA Other specified injuries of abdomen, initial encounter S39.91XA Unspecified injury of abdomen, initial encounter T85.41XA Breakdown (mechanical) of breast prosthesis and implant, initial encounter T85.42XA Displacement of breast prosthesis and implant, initial encounter T85.43XA Leakage of breast prosthesis and implant, initial encounter T85.44XA Capsular contracture of breast implant, initial encounter T85.49XA Other mechanical complication of breast prosthesis and implant, initial encounter T85.79XA Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts, initial encounter Z03.89 Encounter for observation for other suspected diseases and conditions ruled out Z08 Encounter for follow-up examination after completed treatment for malignant neoplasm Z12.31* Encounter for screening mammogram for malignant neoplasm of breast

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 9 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 9 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division Z77.123 Contact with and (suspected) exposure to radon and other naturally occuring radiation Z77.128 Contact with and (suspected) exposure to other hazards in the physical environment Z77.9 Other contact with and (suspected) exposures hazardous to health Z85.3 Personal history of malignant neoplasm of breast Z85.831 Personal history of malignant neoplasm of soft tissue Z85.89 Personal history of malignant neoplasm of other organs and systems Z86.000 Personal history of in-situ neoplasm of breast Z91.89 Other specified personal risk factors, not elsewhere classified Z92.89 Personal history of other medical treatment Z98.82 Breast implant status Z98.86 Personal history of breast implant removal

Note5: *Diagnosis Z12.31 should be reported on the detail line associated with the screening procedure, and one of the diagnosis codes above should be reported on the detail line associated with the diagnostic procedure and modifier GG

REFERENCES

1. Agency for Healthcare Research and Quality (AHRQ) (2016, January). Breast Cancer (Screening) – Recommendations of the U.S. Preventive Services Task Force (USPSTF). Accessed December 10, 2020. Available at URL address: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer- screening

2. American Cancer Society (ACS) (2018). ACS Guidelines for the Early Detection of Breast Cancer. Last Medical Review: May 30, 2018 Last Revised: July 30, 2020. Accessed December 10, 2020. Available at URL address: http://www.cancer.org/healthy/findcancerearly/cancerscreeningguidelines/american-cancer- society-guidelines-for-the-early-detection-of-cancer

3. American College of Radiology (ACR) (2014, November 24). ACR Position Statement on Breast Tomosynthesis. Accessed December 10, 2020. Available at URL address: https://www.acr.org/Advocacy-and-Economics/ACR-Position-Statements/Breast-Tomosynthesis

4. Centers for Medicare & Medicaid Services (CMS) (2020). National Coverage Determination (NCD) for Mammograms (220.4). Publication Number: 100-3. Manual Section Number: 220.4. Version Number: 1. Effective Date of this Version: 5/15/1978. Accessed December 10, 2020. Available at URL address: https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=186&ncdver=1&bc=AAAAQAAAAAAA&

5. Centers for Medicare & Medicaid Services (CMS) (2019). Retired Local Coverage Determination (LCD) for Screening and Diagnostic Mammography (L36342). Contractor Name: First Coast Service Options, Inc. Geographical Jurisdiction: Puerto Rico. Original Effective Date: For services performed on or after 10/01/2015. Revision Effective Date: For services performed on or after

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 10 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 10 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 07/01/2019. Accessed December 10, 2020. Available at URL address: https://localcoverage.cms.gov/mcd_archive/view/lcd.aspx?lcdInfo=36342%3a44

6. Centers for Medicare & Medicaid Services (CMS) (2016, January 04). Medicare Learning Network® (MLN) Matters® Number MM9191. Topic: Claims Processing Instructions for Diagnostic Digital Breast Tomosynthesis. Effective Date: January 1, 2015. Implementation Date: January 4, 2016. Accessed December 10, 2020. Available at URL address: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM9191.pdf

7. Centers for Medicare & Medicaid Services (CMS) (2020). Medicare Claims Processing Manual (CPM). Chapter 18 – Preventive and Screening Services. Rev. 4508, 01/31/2020. Section 20 – Mammography Services (Screening and Diagnostic). Accessed December 10, 2020. Available at URL address: http://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/clm104c18.pdf

8. Centers for Medicare & Medicaid Services (CMS) / Medicare.gov. (n.d.). Medicare Coverage for Mammograms. Accessed December 10, 2020. Available at URL address: http://www.medicare.gov/coverage/mammograms.html

9. Haas, B.; Kalra, V.; Geisel J.; Raghu, M.; Durand, M.; Philpotts, L. (2013, December). Comparison of Tomosynthesis Plus Digital Mammography and Digital Mammography Alone for Breast Cancer Screening. Radiology RSNA Journal: Volume 269, Issue 3. DOI: http://dx.doi.org/10.1148/radiol.13130307. Accessed December 10, 2020. Available at URL address: http://pubs.rsna.org/doi/pdf/10.1148/radiol.13130307

10. Journal of the American Medical Association (JAMA) (2014, June 25). Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography. JAMA: Volume 311, Number 24, Pages 2499 - 2507. DOI:10.1001/jama.2014.6095. Accessed December 10, 2020. Available at URL address: http://jama.jamanetwork.com/article.aspx?articleid=1883018

11. Michell, M.; Iqbal, A.; Wasan, R.; Evans, D.; Peacock, C.; Lawinski, C.; Dourini, A.; Wilson, R.; and Whelehan, P. (2012, May ). A comparison of the accuracy of film-screen mammography, full- field digital mammography, and digital breast tomosynthesis. Clinical Radiology Volume 67, Issue 10, Pages 976 - 981. Accessed December 10, 2020. Available at URL address: http://www.hologic.ca/sites/default/files/Michell%20Summary.pdf

12. National Comprehensive Cancer Network® (NCCN) (2020). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. Version 1.2020 – September 17, 2020. Accessed December 10, 2020. Available at URL address: http://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf

13. “Oficina de Servicios Legislativos (OSL) del Estado Libre Asociado (ELA) de Puerto Rico (PR) (2012). Ley Número 275 del 27 de septiembre de 2012 (P. del S. 2431) – Carta de Derechos de los Pacientes y Sobrevivientes de Cáncer. Artículo 3, Inciso (E) (d)”. Accessed December 10, 2020. Available at URL address: http://www.lexjuris.com/lexlex/Leyes2012/lexl2012275.htm

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 11 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 11 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 14. RadiologyInfo.Org for Patients. (2018, April 12). Breast Tomosynthesis. Accessed December 22, 2020. Available at URL address: https://www.radiologyinfo.org/en/info.cfm?pg=tomosynthesis#overview

15. Skaane, P.; Bandos, A.; Gullien, R.; et al. (2013, April). Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. RSNA Radiology Journal: Volume 267, Issue 1, Pages 47 - 56. DOI: http://dx.doi.org/10.1148/radiol.12121373. Accessed December 10, 2020. Available at URL address: http://pubs.rsna.org/doi/abs/10.1148/radiol.12121373?url_ver=Z39.88- 2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed&, and at URL address: http://pubs.rsna.org/doi/pdf/10.1148/radiol.12121373

16. Skaane, P.; Bandos, A.; Gullien, R. et al. (2013, August). Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programm using independent double reading with arbitration. European Radiology Journal: Volume 23, Issue 8, Pages 2061-2071. DOI: 10.1007/s00330-013-2820-3. PMCID: PMC3701792. Accessed December 14, 2020. Available at URL address: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3701792/, and at URL address: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3701792/pdf/330_2013_Article_2820.pdf

17. South Jersey Radiology Associates (SJRA) (2020). 3D Digital Tomosynthesis Mammography. Accessed December 14, 2020. Available at URL address: http://www.sjra.com/services-list/3d- digital-tomosynthesis-mammography/

18. Tagliafico, A.; Tagliafico, G.; Cavagnetto, F.; Calabrese, M.; and Houssami, N. (2013). Estimation of percentage breast tissue density: comparison between digital mammography (2D full field digital mammography) and digital breast tomosynthesis according to different BI-RADS categories. British Journal of Radiology: Volume 86, Issue 1031. . Accessed December 14, 2020. Available at URL address: http://dx.doi.org/10.1259/bjr.20130255

19. UpToDate® / Venkataraman, S. & Slanetz, P. (2020). Breast imaging for cancer screening: Mammography and ultrasonography. Literature review current through: Nov 2020. This topic last updated: January 08, 2020. Accessed December 14, 2020. Available at URL address: http://www.uptodate.com/contents/breast-imaging-for-cancer-screening-mammography-and- ultrasonography?source=search_result&search=Breast+Tomosynthesis&selectedTitle=1%7E2

20. U.S. Food and Drug Administration (FDA) (2014). 3D Technologies Poised to Change How Doctors Diagnose Cancers. Published: September 30, 2014. Accessed December 14, 2020. Available at URL address: http://www.fda.gov/forconsumers/consumerupdates/ucm416312.htm

21. U.S. Food and Drug Administration (FDA) (2013). Device Approval & Clearance for Selenia Dimensions 3D System - P080003/S001. PMA Applicant: Hologic, Inc. Approval Date: May 16, 2013. Accessed December 14, 2020. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080003s001a.pdf

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 12 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 12 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 22. U.S. Food and Drug Administration (FDA) (2020). Mammography Facilities. Page Last Updated: 12/14/2020. Accessed December 14, 2020. Available at URL address: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mqsa.cfm

23. U.S. Food and Drug Administration (FDA) (2014). Device Approval & Clearance for SenoClaire - P130020. PMA Applicant: General Electric Healthcare. Approval Date: August 26, 2014. Accessed December 14, 2020. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130020a.pdf

24. U.S. Food and Drug Administration (FDA) (2014). Summary of Safety and Effectiveness Data (SSED) for SenoClaire - Digital Breast Tomosynthesis. Premarket Approval Application (PMA) Number P130020. Date of FDA Notice of Approval: August 26, 2014. Accessed December 14, 2020. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130020b.pdf

25. U.S. Food and Drug Administration (FDA) (2011). Summary of Safety and Effectiveness Data (SSED) for the Device Selenia Dimensions 3D System. Date of FDA Notice of Approval: February 11, 2011. Premarket Approval Application (PMA) Number: P080003. Accessed December 14, 2020. Available at URL address: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080003b.pdf

26. Zuley, M.; Bandos, A.; Ganott, M. et al. (2013, January). Digital breast tomosynthesis versus supplemental diagnostic mammographic views for evaluation of noncalcified breast lesions. RSNA Radiology Journal: Volume 266, Issue 1, Pages 89 - 95. DOI: 10.1148/radiol.12120552. PMCID: PMC3528971. Accessed December 14, 2020. Available at URL address: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528971/pdf/120552.pdf

POLICY HISTORY

DATE ACTION COMMENT August 15, 2013 Origination of Policy February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy. September 10, 2014 Revised References Updated.

1. To the Description Section: the description section was res-structured and a new paragragf was added to the end.

2. To the Coding Section: A note of not coverage was added to CPTs codes.

3. To the References section: New References (#1, 2, 3, 4, 5, 6, 11, 14, 16, 17, 18, 19, 20, 23, 24) were added to the Medical Policy.

March 10, 2015 Revised To the Heading Section:  To title of medical policy added: (DBT) (also known as Three- Dimensional [3-D] Mammography).  Added bullet for 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 document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 13 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 13 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

To the References Section:  References updated.  Deleted: BCBS. Technology Evaluation Center (TEC). Use of Digital Breast Tomosynthesis with Mammography for Breast Cancer Screening or Diagnosis. Executive Summary. May 2014. Available at URL Address: http://www.bcbs.com/blueresources/tec/vols/28/use-of-digital- breast-1.html  Deleted: Siemens AG Healthcare / Lindhardt, F. (2010, June). White Paper: Digital Breast Tomosynthesis (DBT) a clinical assessment based on literature. Available at URL address: www.healthcare.siemens.com/siemens_hwem- hwem_ssxa_websites-context- root/wcm/idc/groups/public/@global/@imaging/@mammo/do cum...  Deleted: Siemens AG Healthcare / Mertelmeier, T.; Speitel, J.; and Frumento, C. (2012, March). White Paper: 3D breast tomosynthesis – intelligent technology for clear clinical benefits. Available at URL address: http://www.healthcare.siemens.com/siemens_hwem- hwem_ssxa_websites-context  Deleted: WebMD, LLC. / Medscape / Lin, J. (2013). 3D Mammography. Updated: July 23, 2013.  Deleted: Steven P. Poplack, et al. Digital Breast Tomosynthesis: Initial Experience in 98 women with Abnormal Digital Screening Mammography. American Journal of Roentgenology. September 2007, 189, Number 3. Pag: 616-623. Available at URL address: http://www.medscape.com/viewarticle/562866  Added new references, numbers 1-5, 7-9, 12-15, 20, 24, 30-36, & 39.

To the Description Section:  Deleted: Digital Breast Tomosynthesis (DBT) is a Three- dimensional (3-D) breast imaging technique based on full field digital mammography. Digital tomosynthesis may potentially improve breast imaging and diagnostic capabilities by reducing or eliminating the visual effects of overlapping tissue and shadows that can obscure lesions. During digital breast tomosynthesis examination, the patient’s breast is positioned and compressed as with a standard mammogram.  Deleted: In the process; the compressed breast remains stationary while the x-ray tube moves approximately 1 degree for each image in a 15 to 50 degree arc, acquiring 11 - 49 images. These images are projected as cross-sectional “slices” of the breast, with each slice typically 1 mm thick. By reducing problems caused by overlapping tissue, the amount of compression needed for digital breast tomosynthesis can be reduced by up to 50% compared with mammography, thereby improving patient satisfaction (BCBS, 2014).  Added: 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.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 14 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 14 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division  Added: 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 (UpToDate®, 2015).  Added: In spite of the radiation exposure, DBT 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 (UpToDate®, 2015).

To the *Indications Section:  Deleted: Digital Breast Tomosynthesis is considered not medically necessary in the screening or diagnosis of breast cancer as there is insufficient evidence in published, peer- reviewed literature to support its efficacy. Medical Card System Inc. does not cover digital tomosynthesis for breast imaging because it is considered experimental, investigational or unproven.  Restructured Indications Section into 2 parts: Part I for the Commercial LOB, and Part II for the Classicare (Advantage) LOB.  To new part I of the Indications added: 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) and as an add-on technology to standard digital mammography, when Criteria A plus B are met.  Defined Part I- A as: 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.  Defined Part I- B as: 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

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 15 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 15 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division 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. 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.

 After part II of the Indications added the following Limitation 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 +77063).

 To new part II of the Indications added: 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 the Medicare: •Local Coverage Determination (LCD) for Screening and Diagnostic Mammography (L29329), which corresponds to the geographical jurisdiction of Puerto Rico. Please refer to the aforementioned PR LCD for further details.

To the *General Limitations Section:  Added this new section and specified that the General Limitations Section applies to both LOB.  Added New General Limitations 1 – 4.

To the Coding Information:  Deleted CPT® Codes: 76499, 77055, 77056, & 77057.  Added new CPT® Code Covered for the Classicare LOB only: +77063.  Added New HCPCS Code for the Classicare LOB only, when used exclusively with DBT (3-D) Diagnostic Mammography: G0202.  Added new HCPCS Codes covered for Both LOB: G0204, G0206, & G0279.  Added new HCPCS Modifiers: -TC, -26, -GH, and -GG.  Added New Notes: 1-5.  Separated ICD-9-CM Codes between those used for Screening Mammography (i.e., Codes G0204, G0206 or G0279): V76.11 & V76.12; and those used for Diagnostic Mammography (i.e., Codes G0204, G0206 or G0279 billed with or without Modifier – GG).  Deleted ICD-9-CM Codes: V15.3, V16.3, & V84.01.  To ICD-9 CM® Diagnosis Codes for DBT (3-D) Diagnostic Mammography (i.e., Codes G0204, G0206 or G0279) billed with or without Modifier –GG Section added new ICD-9-CM Codes: 196.3, 198.2, 217, 232.5, 238.3, 239.2, 239.3, 451.89, 611.2, 611.3, 611.4, 611.5, 611.81, 611.82, 611.89, and 793.81.  Added new ICD-10 Codes: C77.3, C79.2, D24.1, D24.2, D24.9, D04.5, D48.60, D48.61, D48.62, D49.2, D49.3, I80.8, N64.0, N64.1, N64.2, N64.89, R92.0.  Added new CPT® Codes Non-covered for Both LOB: 77061 & 77062.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 16 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 16 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

*Changes done within the Indications and Limitations Section were reviewed and approved by the MCS Medical Advisory Committee (MAC) on March 10, 2015. May 18, 2015 Revised References updated. November 23, 2015 Revised To the coding section:  Eliminate ICD-9 codes since they are no longer valid for diagnosis classification.  Add new section of ICD-10 codes which are the valid diagnosis classification system since October 1, 2015. April 19, 2016 Revised To the coding section:

New ICD-10 Codes were added: C43.52, C43.59, C44.501, C44.509, C44.511, C44.519, C44.521, C44.529, C44.591, C44.599, C45.9, C56.1, C56.2, C56.9, C78.00, C78.01, C78.02, C78.1, C78.2, C78.7, C79.31, C79.32, C79.40, C79.49, C79.51, C79.52, C79.60, C79.61, C79.62, C80.0, C80.1, D03.52, D03.59, D22.5, D23.5, D48.5, D49.1, D49.6, D49.7, M70.80, M70.88, M70.89, M70.90, M70.98, M70.99, M79.5, M79.81, M79.89, M79.9, N65.0, N65.1, R59.0, R59.1, R59.9, R93.9, S20.00XA, S20.01XA, S20.02XA, S21.001A, S21.002A, S21.009A, S21.011A, S21.012A, S21.019A, S21.021A, S21.022A, S21.029A, S21.031A, S21.032A, S21.039A, S21.041A, S21.042A, S21.049A, S21.051A, 21.052A, S21.059A, S28.211A, S28.212A, S28.219A, S28.221A, S28.222A, S28.229A, S29.001A, S29.009A, S29.091A, S29.099A, S29.8XXA, S29.9XXA, S39.001A, S39.091A, S39.81XA, S39.91XA, T85.41XA, T85.42XA, T85.43XA, T85.44XA, T85.49XA, T85.79XA, Z03.89, Z08, Z77.123, Z77.128, Z77.9, Z85.831, Z85.89, Z91.89, Z92.89, Z98.82 and Z98.86.

To the References Section: References #5, 17, 18 and 39 were deleted from this Policy. July 18, 2017 Revised To the Limitations Section:  Code +77063 was deleted and Substitute by the code 77067 at the Limitation #1.

To the General Limitations Section:  Limitation #4 was deleted from this Policy.

To the Coding Information Section:  New CPT Codes Box covered for the Commercial LOB Only, for DBT (3-D) Diagnostic Mammography was added to the Policy.

 New CPT Codes 77065 and 77066 were added to the Policy.

 Phrase “Both the Commercial &” was deleted from the Statement of HCPCS Codes Box.

 To the ICD-10 Codes Section: The following ICD-10 Codes were added to the Policy: N61.0 and N61.1.

The following ICD-10 Codes were deleted from this Policy: C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.919, C50.929, C56.9, C78.00, C79.60, D05.00, D05.10, D05.80, D05.90, D24.9, D48.60, N60.09, N60.19, N60.29, N60.39, N60.49, N60.89, N60.99, N61, S20.00XA, S21.009A, S21.019A, S21.029A, S21.039A, S21.049A, S21.059A and S28.219A.

To the References Section:  Reference #4 was deleted from this Policy. December 31, 2018 Revised To the References Section:

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 17 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 17 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division  References 1, 2, 6, 10, 12 were updated  References 4, 8, 9, 14, 19, 23, 27 were eliminated

To the coding Section:  Codes G0202, G0204, G0206 were eliminated and replaced: G0202 replaced by 77067 G0204 replaced by 77066 G0206 replaced by 77065 January 16, 2020 Revised To the Indications Section:

 To IB7: New Phrase “and includes a physician’s interpretation of the results of the procedure” was added to the Indication B7.  Phrase “under the Following reference” was added to the Classicare Statement- Section II.  LCD was deleted and modified to the NCD 220.4 in the Classicare link according to the CMS decision to Retired the LCD L36342 at the Section II.

To the Coding Information Section:

To the ICD-10 Section:  The Following ICD-10 Codes were added to the Policy: N63.11, N63.12, N63.13, N63.14, N63.20, N63.21, N63.22, N63.23, N63.24, N63.31, N63.32, N63.41, N63.42, and Z86.000.

 The Following ICD-10 Codes were deleted from this Policy: N60.81, N60.82, N60.91, N60.92, N63, and Z98.86.

 New Note5 was added to the Policy from LCD L36342.

To the References Section:  New Reference #7 was added to the Policy.

 The following References were delered this Policy: #3 and 6. December 24, 2020 Revised To the General Limitations Section: To the Limitation #3:  New Information was added to the Medical Record point “D”: 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.

 New Limitation “F” was added to the Policy.

To the Coding Information Section:  To the HCPCS Code G0279 for Classicare: New Note6 was added to the Policy according to the information contained in the coding section from Centers for Medicare & Medicaid Services (CMS) (2019). Retired Local Coverage Determination (LCD) for Screening and Diagnostic Mammography (L36342).

 To the ICD-10 Codes Section: The following ICD-10 Codes were added to the Policy: N60.81, N60.82, N60.91, N63.10, and Z98.86.

The following ICD-10 Codes was deleted from this Policy: S28.229A.

To the References Section: The following References was added to the Policy: #15

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 18 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 18 All Rights Reserved®

Clinical Medical Policy Department Clinical Affairs Division

The following References were deleted from this Policy: #3 and 27.

This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member’s plan in effect as of the date services are rendered. Medical Card System, Inc., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. Medical Card System, Inc. (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan’s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide.

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 19 Medical technology is constantly changing and we reserves the right to review and update our policies periodically. Medical Card System, Inc. 19 All Rights Reserved®