For American women, breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer mortality behind lung cancer. The American Cancer Society (ACS) estimates that in 2004, 215,990 women will be diagnosed with breast cancer, and 40,110 women will die from the disease. Largely because of mammography screening, 63 percent of breast cancers are diagnosed at a localized stage, which has a five-year survival rate of 97 percent, according to the ACS. Mammography screening combined with clinical breast examination is the best technique available for early breast cancer detection.
Due in large part to concerns over patient safety and the quality of mammography screening, the ACR and the United States Congress sought to implement legislation that would regulate mammography screening at the federal level. The intent of this legislation was to establish minimum standards that would ensure that all women have access to quality mammography services. The Mammography Quality Standards Act (MQSA) became law on October 27, 1992 (P.L. 102-539).
MQSA required the Department of Health and Human Services (HHS) to develop standards that would be enforced through strict accreditation, certification and inspection, of equipment and personnel at mammography facilities. The Food and Drug Administration (FDA) was tasked with implementing the federal regulations, which it published in October 1997, used to establish and enforce such procedures. These regulations were last updated in October 2002. The ACR is one of four FDA-approved accreditation bodies. A report by the United States Senate Committee on Health, Education, Labor and Pensions, which accompanies S. 1879, the Mammography Quality Standards Reauthorization Act (MQSRA) of 2004, touts the success of this program with statistics indicating that over 60 percent of facilities have no violations, only 2 percent have serious non-compliance issues, and over 99 percent pass the phantom image test during inspection.
During the 108th Congress, the ACR worked closely with the ACS and the Susan G. Komen Breast Cancer Foundation to develop reauthorization language for MQSA. On November 18, 2003 S. 1879, the MQSRA of 2004, was introduced in the Senate by Senator Barbara Mikulski (D-MD). Traditionally, MQSA, which was last reauthorized in 1998, has been on a five-year appropriations reauthorization cycle. The ACR, ACS, and Komen, however, negotiated a two-year reauthorization with Senator Mikulski and Senate HELP Committee Chairman Judd Gregg (R-NH) to allow for the timelier incorporation of results from separate studies by the Institute of Medicine (IOM) and the Government Accountability Office (GAO) that are scheduled for release in 2005.
The purpose of these studies is to determine whether some of the original MQSA regulations are unnecessary as well as to examine quality and access issues relating to mammography. While GAO has yet to release its report, IOM published its findings, Improving Breast Imaging Quality Standards, on May 23, 2005. The ACR urges Congress to be certain that the IOM recommended measures are feasible, allow for an adequate period of implementation, and do not reduce access for women.
On November 21, 2003, Chairman Judd Gregg (R-NH) of the Senate HELP Committee conducted a mark-up and MQSRA was ordered to be reported. S. 1879 passed the Senate on February 2, 2004 and was referred to the Subcommittee on Health of the House of Representatives Committee on Energy and Commerce.
In the House of Representatives, Representative John Dingell (D-MI) introduced companion legislation, H.R. 4555. Of greatest significance, this bill reauthorizes appropriations through FY 2007 for breast cancer screening surveillance research grants and for mammography facilities certification activities not supported by fees.
Additionally, the Energy and Commerce Health Subcommittee amended H.R. 4555 with a provision adding two industry representatives with expertise in mammography equipment to the National Mammography Quality Assurance Advisory Committee. Energy and Commerce Committee chairman, Joe Barton (R-TX) believes industry representation on the Advisory Committee should be beneficial to HHS and the FDA as they determine appropriate quality standards and regulations for mammography facilities.
H.R. 4555, as amended, passed the House of Representatives by voice vote on October 5, 2004 and passed the Senate by unanimous consent on October 9, 2004. President George W. Bush signed this bill into law on October 25, 2004 (P.L. 108-365).