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Published on April 21, 2011

Contact: Julie McDowell
Phone: 202-354-7127
E-mail: jmcdowe@cap.org

CAP Statement on CMS’s Withdrawal of the Cytology Proficiency Testing Proposed Rulemaking

Washington, DC—The Centers for Medicare & Medicaid Services (CMS) is withdrawing the cytology proficiency testing (PT) notice of proposed rulemaking (NPRM), according to an April 8 letter sent from the agency to state survey agency directors.

The CAP is concerned that the agency has not updated the program to keep pace with current science and technology since it was initially issued in 1992 to implement the Clinical Laboratory Improvement Amendments (CLIAC) of 1988. Indeed, the College, along with its over 60 partners in the Cytology PT Coalition, garnered significant bi-partisan support in the 110th Congress for legislation, the “Cytology Proficiency Improvement Act,” that would have brought the current regulation into the 21st century. While opposed by CMS, this legislation offered a sound and more effective alternative to the outmoded program now in place. Widely viewed as a workable solution, the bill passed the House and had the support of 43 Senate co-sponsors before the session closed in January 2009. Despite their opposition to this legislation, CMS, reacting to Congressional pressure, issued a NPRM in early 2009 to make changes to the program. However, the proposed changes fell short of what was needed to address CAP’s fundamental concerns.

The College appreciates that CMS will implement some feedback from the NPRM into the current PT program, and is committed to continuous quality improvement. CMS officials also believe that quality has improved in this area of testing, explaining that “the number of individuals who scored less than the passing score of 90% has decreased significantly over time.” While the CAP is pleased to hear about efforts to improve the program, it also maintains that the regulation is fatally flawed, and the proposed changes do not go far enough to correct these flaws.

The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community. It is the world’s largest association composed exclusively of board-certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective patient care.