From the July 2019 issue of HealthCare Business News magazine
The vendor market is currently in its infancy, with the first systems FDA-approved for use in the U.S. in 2018. Currently there are four vendors that have developed systems. iCAD’s and ScreenPoint Medical’s product lines are currently FDA-approved and are available in the U.S. European-based Therapixel (Mammoscreen) and Kheiron Medical Technologies (MIA) have CE markings (indicating conformity with European Economic Area standards) but are not available in the U.S.
Though this is still an emerging market, iCAD is currently the market leader in the field. iCAD offers two systems: the PowerLook, which is targeted to breast tomosynthesis, and the SecondLook for 2D mammography. These systems are offered as stand-alone workstations under iCAD’s letterhead or as an add-on to Hologic, GE, and Siemens mammography systems. ScreenPoint Medical’s Transpara system is FDA-approved, but we have not seen this system sold in the U.S.
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There is a wide range of pricing for base mammography technology. Basic Digital systems range from $190,000 for 2D technology to over $400,000 for 3D technology. Tomosynthesis systems start at $500,000. Artificial intelligence is designed to be used as an add-on workstation platform. A complete system includes a workstation and software license. Pricing is similar to CAD technology, which can range from $60,000 to $100,000 depending on the number of software licenses. Service for the platforms start at $8,000 per year, and software support is approximately $3,000 per license.
Reimbursement is key for the adoption of any technology. CMS first approved reimbursement for CAD in 2002 as an add-on code. This increased payment an average of $15 per study. In 2018, computer-aided detection (CAD) was wrapped in with both digital screening and diagnostic codes under the 5-digit CPT codes. This is a clear indication that CAD has become a standard of care over the years. Unless vendors lobby CMS for a unique code, AI will be wrapped into screening and diagnostic codes similar to the CAD payment structure.
Current Payment Structure
77065 - Diagnostic mammography, including computer-aided detection (CAD) when performed; unilateral — $96 (CMS average payment level, Technical Component)
77066 - Diagnostic mammography, including computer-aided detection (CAD) when performed; bilateral — $122 (CMS average payment level, Technical Component)
77067 - Screening mammography, bilateral (2-view study of each breast), including computer aided detection (CAD) when performed — $101 (CMS average payment level, Technical Component)
