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DESCRIPTIONComputer-aided detection (CAD) has been suggested as an adjunct to screening mammograms to decrease errors in perception (i.e., failure to see an abnormality). The use of CAD systems requires a digital image, either generated by digitization of a prior screen-film mammogram (digitized mammogram), or generated directly (direct full-field digital mammogram). Commercially available CAD systems then use computerized algorithms for identifying suspicious regions of interest on the digital image. The locations of the abnormalities are marked such that the reader can then reference the same areas in the original mammogram for further review. The intent of CAD is to aid in detection of potential abnormalities for the radiologist to re-review. The radiologist, not CAD, makes the diagnosis if a clinically significant abnormality exists and whether future diagnostic evaluation is warranted.
The distinction between digitized screen-film mammograms (SFM) and direct full-field digital mammograms (FFDM) is important. Since these two images are generated in different ways, the associated diagnostic performance of adjunctive CAD must be considered separately. Conceptually, the CAD systems used with digital mammography are very similar to those used with film mammography. The computer analyzes the digital images collected directly by the FFDM system, applies a set of algorithms that capture characteristics known to be associated potentially with malignancies, and produces an image with markings that show the site of suspicious findings. Sometimes, different marks are used for suspected masses and suspected microcalcifications. The major difference between CAD for FFDM and CAD for SFM is the extensive data set provided by the former and its interaction with the CAD algorithms.
POLICYComputer-aided detection devices as an adjunct to single-reader interpretation of digitized screen-film mammograms may be considered medically necessary.
Computer-aided detection devices as an adjunct to single-reader interpretation of direct, full-field digital mammography is considered investigational.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY4/9/2007: Policy added
5/11/2007: Bancorp South (C427, C445, C458, and C550) policy exception added
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
5/9/2008: Policy reviewed, no changes
05/08/2013: Policy reviewed; no changes.
12/31/2014: Added the following new 2015 CPT codes to the Code Reference section: 77061, 77062, and 77063. Revised the description of the following HCPCS codes with an effective date of 01/01/2015: G0204 and G0206.
04/27/2015: Removed CPT codes 77061, 77062, and 77063 from the Code Reference section. These procedures are specifically addressed by the Digital Breast Tomosynthesis medical policy guidelines.
07/13/2015: Code Reference section updated for ICD-10.
09/17/2015: Policy Exceptions updated to remove language for BancorpSouth.
12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to revise the description of the following CPT code with an effective date of 01/01/2016: 77057.
06/08/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 6.01.39
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.