January 20, 2012
Louis Jacques, MD
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Re: Coverage with Evidence Development (CED) Public Solicitation for Comment
Dear Dr. Jacques:
On behalf of Riverain Technologies, a healthcare company that offers chest radiology (CXR) computer-aided detection (CAD) software for early lung cancer detection, I would like to thank you for the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding the coverage with evidence development (CED) process. We commend CMS for reexamining the guidelines for CED and are pleased to provide the following comments in support of CMS’ continued use of CED to improve access to innovative medical technologies for Medicare beneficiaries. CED offers a unique opportunity for the collection of essential data to ensure that new technologies are appropriately assessed based on the risks or rewards they offer Medicare beneficiaries.
Riverain’s CXR CAD technology is a Food and Drug Administration (FDA) approved tool available to help radiologists detect early stage lung cancer. Lung cancer is the #1 cause of cancer death because the disease is not typically detected in its early and most treatable stages.
Separately from the interpretation of the chest x-ray, CXR CAD is used by radiologists to identify regions of interest on x-rays that might represent nodules that could be early stage lung cancer. Peer reviewed studies have shown that CXR CAD increases the detection of missed nodules by up to 50 percent.* CXR CAD is currently reimbursed as part of a bundle of services under “image processing.” While CXR CAD is considered covered by CMS, it is our understanding that most hospitals and radiologists do not use the technology because the bundled payment does not cover the cost of the CAD; payment for CXR CAD is the same as the payment for CXR on its own. Therefore Medicare beneficiaries lose out on the opportunity for early disease detection.
Riverain recommends that CMS consider including technologies that are currently part of a bundled payment system for individual reimbursement through the CED process so that data might be collected on the technology to demonstrate its impact on health outcomes for Medicare beneficiaries. While we appreciate that CMS continues to pay for certain services as part of a bundled payment system, it is clear that CAD is not being used to its potential to help detect lung cancer at an early stage as it is not sufficiently reimbursed within the bundle.
Allowing CAD, and possibly other innovative technologies that are currently part of a bundled payment system, to be eligible for separate reimbursement through CED, will provide CMS with the data needed to fully understand the benefits that CAD can provide to Medicare beneficiaries.
In response to past comment on a separate payment for CAD, CMS responded, “We believe it is appropriate to maintain the packaged status of [CAD] because we received no additional data subsequent to the CY 2009 OPPS/ACS proposed rule that convinced us to change this policy.” This comment clearly demonstrates the need for additional data collection on the CAD technology, which cannot be sufficiently done when CAD is part of a bundle of services for image processing that does not adequately cover the cost of the technology or the personnel required to interpret the results. Allowing CAD to be eligible for CED and given a separate reimbursement will give CMS the opportunity to fully understand the life-saving benefits of the technology.
Without the ability to collect and examine data on the impact that CXR CAD has on lung cancer detection, CMS might not know the life-saving benefits the technology could provide to beneficiaries. With two-thirds of all lung cancer cases occurring in Medicare-aged patients, it is essential for CMS to be willing to adopt the most innovative early detection technology.
Thank you for your consideration of Riverain’s comments. Expanding the CED program to include innovative technologies that are currently part of a bundled payment program will allow for new data collection on potentially life-saving technologies and will certainly have a positive impact on health outcomes for Medicare beneficiaries. We are very eager to put our technology through the rigors of evidence development via the CED program because we feel that CMS will find results similar to our clinical trials. Riverain applauds CMS for its review of these guidelines and its effort to provide Medicare beneficiaries with access to the most innovative technologies.
Diane A. Hirakawa, Ph.D.
CEO and Chairman
3020 South Tech Boulevard
Miamisburg, OH 45342-4860
*Source: Chen J and White C (2008). Use of CAD to Evaluate Lung Cancer on Chest Radiography. Journal of Thoracic Imaging. 23:93-96.