The American College of Radiology (ACR) has formally asked for improvements to the Lung Cancer Mortality Reduction Act (H.R. 1394/S. 752), which calls for the development of a comprehensive government strategy to spark a 50% decrease in lung cancer mortality by 2020 and initiate a demonstration project that would permit lung cancer patient screening via low-dose CT.
While it endorses initiatives stipulated in the legislation, the ACR made the request of its co-sponsors in the U.S. House of Representatives and the U.S. Senate, specifically Representatives Donna Christensen, MD, (D-Virgin Islands) and Frank LoBiondo (R-NJ) and Senators Dianne Feinstein (D-CA), John Kerry (D-MA) and Johnny Isakson (R-GA). These improvements focus primarily on the role of the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) in the lung cancer mortality reduction plan and CT lung cancer screening demonstration project to be created under the bill’s provisos.
One portion of the bill to which the ACR objects is contained in Section 4, which authorizes the FDA’s Center for Device and Radiologic Health (CDRH) to establish quality standards and guidelines for facilities that conduct CT lung cancer screening and charges it with providing an expedited review of the standards and guidelines to accommodate technological advances in imaging, as well as annually surveying a random sample of imaging facilities to assess overall compliance. The ACR believes its experience in guidelines development, accreditation, and appropriateness criteria render it better suited than the FDA to develop CT screening guidelines. “There is also strong concern that new FDA regulations would overlap, conflict and possibly undermine imaging requirements enacted by Congress through the Medicare Improvement for Patients and Providers Act (MIPPA) of 2008,” according to a statement issued by the society this week.
The ACR also asked the co-sponsors to revise Section 6 of the bill, which calls for a lung cancer screening demonstration project and authorizes the HHS Secretary to establish quality standards and guidelines for the purposes of licensing facilities that conduct CT lung cancer screening through the project. These provisions, ACR says, overlap with the problematic FDA guidelines outlined in Section 4 and may undermine accreditation concepts enacted through the Medicare Improvements For Patients and Providers Act. “Also, the ACR Dose Index Registry will accurately capture radiation exposure from CT lung cancer screens in a manner far superior to that outlined in the legislation,” the statement purports.
A final request to the bill’s co-sponsors stipulates that Section 7 of the legislation, which would create a lung cancer advisory board, be revised to expand the membership of the board to include medical physicists.
To read the press release, click here: http://www.acr.org/HomePageCategories/News/ACRNewsCenter/ACR-Lung-Cancer....