|MP 6.01.34||Full-Field Digital Mammography|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/2:2005
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
A limitation of screen-film mammography is the film itself. Once a screen-field mammogram is obtained, it cannot be significantly altered. Contrast loss due to film underexposure, especially of dense glandular tissues, cannot be regained through film display. However, if a mammogram is rendered in a digital format, the image can be manipulated in a variety of ways to highlight lesion conspicuity. In addition, image storage, transmission, and retrieval can be improved. Digital images can be processed by a computer and displayed in multiple formats, on film or on a monitor. Computer-aided detection software to assist the radiologist in interpreting the images can also be used to provide a second opinion and improve diagnostic accuracy. (Note: Computer-aided detection of mammographic images is NOT addressed in this policy. Please refer to policy No. 6.01.39 for a discussion of computed-aided detection.)
Mammograms can be rendered in a digital format in 2 different ways. Conventional film screen mammograms can be converted to a digital image, referred to as a digitized screen-film mammogram, or a mammogram can be generated as a digital image de novo, referred to as a direct full-field digital mammogram. This distinction is important, since images are generated in 2 different ways. Therefore, data regarding their diagnostic performance must be considered separately.
Direct full-field digital mammography may be considered medically necessary, both as a screening or diagnostic technique.
Note: This policy only addresses digital or digitized mammography WITHOUT the adjunctive use of computer-aided detection (CAD). Computer-aided detection using digital or digitized mammograms is addressed separately in policy No. 6.01.39. Digitized screen-film mammography is rarely used for purposes other than computer-aided detection. There may be some facilities that perform digitization of screen-film mammography for storage purposes but that would not be a medical necessity issue.
A series of 3 HCPCS G codes (G0202, G0204, G0206) specifically describes direct full-field digital mammography. According to this policy, all 3 of these codes may be considered medically necessary. There is no HCPCS code that describes the generation of a digitized mammogram, either with or without adjunctive CAD. In contrast, there are CPT codes (76082-76083) that describe the conversion of an original film mammography to a digitized image with associated computer analysis.
There is no CPT code that describes direct full-field digital mammography, either with or without adjunctive CAD.
BlueCard/National Account Issues
While there is no national Medicare coverage decision regarding digital mammography, coverage of digital mammography was addressed legislatively in the Benefits Improvement and Protection Act 2000 (BIPA). Under a provision in this act, payment for technologies that directly take digital images would equal 150% of the amount that would otherwise be paid for bilateral diagnostic mammography.
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.
This policy regarding full-field digital mammography without associated computer-aided detection (CAD) was originally based on a 2002 TEC Assessment (1) that concluded there was insufficient evidence to permit conclusions about the diagnostic performance of full-field digital mammography (FFDM) relative to screen-film mammography (SFM) both for screening and diagnosis. The 2002 Assessment based its conclusions primarily on the screening study of 6,736 patients by Lewin et al (2) and the 1 published article regarding digital mammography for diagnosis in 692 patients by Venta. (3) These studies did not detect significant differences(p>0.1) in FFDM when compared to SFM, and the 2002 TEC Assessment concluded that more information from larger studies was needed to permit conclusions regarding the effect of using digital mammography on health outcomes.
In October 2005, an updated TEC Assessment concluded that FFDM met the Blue Cross and Blue Shield Association TEC criteria. (4) The conclusions of this Assessment were based on the results of the American College of Radiology Imaging Network’s (ACRIN) Digital Mammographic Imaging Screening Trial (DMIST). (5, 6) This trial provided results on 42,760 asymptomatic women who had both FFDM and SFM. The trial showed with reasonable certainty that there was no difference in accuracy of the 2 modalities for asymptomatic women in general. For 3 subgroups of women, however, FFDM performed better than SFM: women under age 50; pre- or perimenopausal women; and women with heterogeneously dense or extremely dense breasts. For any constant specificity in the 0.7 to 0.95 range, the sensitivity is higher for FFDM than for SFM. Conversely, for any sensitivity in the 0.4 to 0.7 range, the specificity is higher for FFDM than for SFM.
There were no strong, new studies on the use of FFDM versus SFM in a diagnostic population. However, the DMIST results indicated that tumors detected by FFDM but not by SFM were likely to be invasive carcinomas or medium- to high-grade ductal carcinoma in situ (DCIS). Based on the supposition that these are the cancers of greatest interest and the ones more likely to be found in a diagnostic population and that the diagnostic population is younger on average than the screening population, it was concluded that there is sufficient evidence to support the use of FFDM for diagnostic purposes. This judgment was supported by a small study of follow-up digital and film mammograms among 100 subjects with radiological abnormalities on initial screening film mammography. (7) There was no difference between digital and film mammography, as measured by the area under the receiver operating characteristic (ROC) curves.
The 2005 TEC Assessment also noted another major study, the Oslo II study (8). This study was a trial of 25,262 women aged 45–69 years old who were randomized to receive either digital mammography or film mammography. While the results of this study suggested the equivalence of FFDM and SFM for the detection of cancer, there were important limitations in the study design and execution.
In conclusion, the 2005 TEC Assessment noted there is strong evidence showing that digital mammography is as accurate as film mammography for screening uses. Furthermore, FFDM performs better than SFM precisely in those populations where SFM is weaker. The increased accuracy also appears to be obtained at radiation doses that are no higher and may be lower than those found with SFM. The evidence regarding the use of FFDM for diagnostic purposes has been extrapolated from the DMIST results, as well as a small follow-up study on women with abnormalities detected in the initial screening film mammography. However, given the distribution of cancers detected in the DMIST population, digital mammography’s use for diagnosis appears warranted. In comparing these modalities overall, however, it should be kept in mind that the differences in accuracy are small, that mammography using either mode will produce many false positive results that require follow-up, and that some cancers that would have been detected using film mammography will not be found using digital mammography and vice versa.
- 2002 TEC Assessment: Full-field Digital Mammography.
- Lewin JM, D'Orsi CJ, Hendrick RE et al. Clinical comparison of full-field digital mammography and screen-film mammography for detection of breast cancer. AJR Am J Roentgenol 2002; 179(3):671-7.
- Venta LA, Hendrick RE, Adler YT et al. Rates and causes of disagreement in interpretation of full-field digital mammography and film-screen mammography in a diagnostic setting. AJR Am J Roentgenol 2001; 176(5):1241-8.
- 2005 TEC Assessment: Full-field Digital Mammography.
- Pisano ED, Gatsonis CA, Yaffe MJ et al. American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial: objectives and methodology. Radiology 2005; 236(2):404-12.
- Pisano ED, Gatsonis CA, Hendrick E et al. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med 2005; 353(17):1773-83.
- Uchiyama N, Tajima H, Machida M et al. Clinical evaluation of full-field digital mammography in comparison with screen film mammography by hard copy images. In: Scientific program and abstracts of the Radiological Society of North America 87th Scientific Assembly and Annual Meeting; November 25-30, 2001; Chicago, IL. Abstract 388.
- Skaane P, Skjennald A. Screen-film mammography versus full-field digital mammography with soft-copy reading: randomized trial in a population-based screening program - the Oslo II Study. Radiology 2004; 232(1):197-204.
|ICD-9 Diagnosis||V10.3||Personal history of breast cancer|
|V16.3||Family history of breast cancer|
|V76.11||Screening mammogram for high-risk patient|
|V76.12||Other screening mammogram|
|V76.19||Other screening breast examination|
|HCPCS||G0202||Screening mammography, producing direct digital image, bilateral, all views|
|G0204||Diagnostic mammography, producing direct digital image, bilateral, all views|
|G0206||Diagnostic mammography, producing direct digital image, unilateral, all views|
|Type of Service||Radiology|
|Place of Service||Outpatient|
Full-Field Digital Mammography
|5/15/02||Add to Radiology section||New policy|
|04/29/03||Replace policy||Policy updated with additional coding information; no change to policy statement|
|05/23/05||Replace policy||Policy updated with literature search; no change in policy statement. Discussion added to Rationale section regarding Oslo II study, reference number 5 revised|
|12/14/05||Replace policy||Policy updated with October 2005 TEC Assessment; policy statement revised from investigational to may be considered medically necessary|