The following information may assist you when working with private payers in your locality to assure appropriate coverage of full field digital mammography (FFDM). The American College of Radiology (ACR) currently maintains the following position on private payer coverage of FFDM (note, this position may change once the results of the ACR Imaging Network (ACRIN) trial become available):
- FFDM should be covered and is not investigational;
- Digital mammography is FDA approved and thus coverage of digital mammography should be no different from coverage of digital fluoroscopy, chest x-ray, angiography, etc. All of these modalities converted to digital with no change in coding or reimbursement;
- The ACR supports coverage of FFDM at the same rate as film screen mammography;
- The ACR Committee on Coding and Nomenclature has taken the position that if the private payers' system is not set up to recognize HCPCS codes (and therefore the G-codes that have been developed for FFDM), the technology should be billed using CPT codes for film mammography, 76090-76092.
The following information is included below:
- A link to the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) technology assessment of FFDM;
- Links to information on FFDM certification and accreditation requirements from the FDA website; and
- Links to information about the ACRIN trial that is investigating how digital mammography compares to film screen mammography.
With respect to FFDM, many of the independently owned and operated Blues plans and other private payers base their coverage decisions specific to FFDM on the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Technology Assessment (TA) of FFDM (July 2002). A copy of the report is below. Note the five criteria the BCBSA TEC require a new technology to meet in order for them to approve its use.
In the instance a payer references this technology assessment, it is important to bring forth additional information that was not included in the BCBSA TA. For example, the July 2002 BCBSA technology assessment did not take into account a larger series by Lewin, et. al. AJR:Sep 2002;179:671- 678. This article essentially concludes:
- No significant differences in cancer detection rate
- Significantly lower recall rate for FFDM
- PPV higher for FFDM
- No significant difference in ROC curve
Since the BCBSA technology assessment was published, a large-scale study was published in Radiology (Skaane P and Skjennald A. Radiology:2004;232:197-204) that showed a higher detection rate for FFDM than film screen mammography for women ages 50-69, and no difference in detection rate for women ages 45-49. The study concluded that "FFDM with current production equipment is equivalent to SFM for breast cancer detection and consequently well suited for use in screening mammography."
It is also important to note that ECRI, a technology assessment organization separate from the BCBSA, states that the lower recall rate is of high clinical significance since there is a corresponding reduction in the number of negative biopsies.
It is important to point out to insurers that the Food and Drug Administration (FDA) does not classify FFDM as investigational. The FDA has stated, "FFDM is a technology for radiography of the breast and, therefore, is a mammographic modality. Until fairly recently, FFDM was classified as an investigational use of mammography and thus was exempted from the MQSA requirements. However, FFDM units produced by a growing number of manufacturers have now been approved by FDA for commercial distribution. Such approved units are subject to the MQSA requirements. However, those FFDM units that are not yet cleared for commercial distribution are still viewed as investigational units and continue to be exempt from the MQSA requirements." For information regarding FFDM certification requirements, see below.
The FDA has approved FFDM units sold by GE, Fischer and Lorad as safe and effective for the screening and diagnosis of breast cancer after they submitted (and had approved) a detailed Premarket Approval Application (PMA). They also approved the ACR to accredit these units. Note that the FDA requirements for Quality Control inspection of FFDM are more rigorous than for film-screen.
Other benefits of FFDM which you could raise to your payer include:
- Decreased patient anxiety secondary to lower recall rate
- Increased patient access due to efficiency of exam and fewer recalls
- Easier transmission of images for expert consultation
- Decreased cost to the payer because of fewer recalls
The ACR started accrediting the GE Senographe 2000D on February 15, 2003, the Fischer Senoscan on August 15, 2003 and the Lorad Selenia on September 15, 2003. Visit the ACR website for more information on ACR breast imaging accreditation.
The ACR Imaging Network is conducting on-going research to "find out whether digital mammography is as good as or better than standard, screen-film mammography" though their Digital Mammography Imaging Screening Trial (DMIST). This work is being conducted with both FDA-approved units and several that are not yet FDA approved. For more information on the ACRIN trial, see the links below.