Proposed Legislative Changes in Proficiency Testing


January 20, 2009



Dear Colleagues,


The Centers for Medicare and Medicaid Services published amendments to Cytology Proficiency Testing (PT) in the Federal Register, January 16.  These proposed amendments are partly based upon the suggestions of an advisory committee that were made three years ago.  These amendments are for changes in the regulatory requirements for proficiency testing.  Legislative changes in proficiency testing were not successfully passed in the 110th Congressional session.


We now have 60 days to comment on the proposed regulatory changes.  As cytology professionals, it is our duty to make constructive comments for improvements in our field. Who knows what the impact of these changes will be better than you?  When responding to the proposals, please respond directly to the specific questions raised by CMS. Please be concise, objective and scientific. Although we may be passionate about our profession, we should use this comment period to provide an unemotional, objective assessment of the changes that may occur in cytology as a result of the proposed changes in PT. 


The deadline for all comments is March 17, 2009 at 5:00 pm.  CMS has called for comments concerning 14 different aspects of PT: 1) Cytology challenges and new technology, 2) testing individuals, 3) testing frequency, 4) number of challenges, 5) response categories, 6) referencing challenges,  7) biopsy confirmation, 8) validation of challenges, 9) scoring, 10) re-testing and remediation, 11) appeals,12) initial testing site, 13) proctors, and 14) collection of  information requirements. You may respond electronically, by regular mail, express or overnight mail, or by hand or courier (Fax responses are not accepted).


A copy of the proposed rules, a list of specific comments and the addresses for responses are now available at our website  Please be active. Respond to the proposed regulations in Proficiency Testing.


With best regards,

Ann T. Moriarty,

President, American Society of Cytopathology


Specific Comments for CMS

Download a printable version of CMS 42 CFR Part 493
Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program; Cytology Proficiency Testing (PT); Proposed Rule