In a significant development in the ongoing debate surrounding cytology proficiency testing (PT), the Centers for Medicare and Medicaid Services (CMS) has agreed to a recent CAP request that the agency suspend penalties under the PT program through 2006.

"We believe your recommendation has merit," CMS Administrator Mark McClellan said in a Jan. 20 written response to a Dec. 22 letter from CAP President Thomas Sodeman, MD, FCAP, who urged the agency to suspend penalties this year so Congress may fully consider CAP-backed legislation to suspend and revise the program. That bill, the Proficiency Testing Improvement Act of 2005 (H.R. 4568), won House approval Dec. 17 and now awaits Senate action.

McClellan said the PT program would continue as "previously adopted in 2005," meaning that laboratories "will not be cited for deficiencies or have sanctions imposed against their CLIA certificate for failure to comply with the cytology PT requirements," provided they enroll all affected individuals in a CMS-approved testing program for the calendar year testing cycle; and ensure that all such individuals are tested within 2006 "in accordance with the regulatory protocol and timeframes" specified in the 1992 regulations for the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Even with the suspension of penalties, laboratories and individuals still must enroll in an approved PT program and all testing for the 2005 calendar year testing cycle must be completed by April 2, 2006, CMS said. Civil monetary penalties of up to $10,000, limitations on a laboratory's CLIA certificate or suspension of Medicare payment for cytology testing—or a combination of any of those remedies—could result from failure to comply with the enrollment and testing provisions.

Since CMS' decision in fall 2004 to move forward with cytology PT, the College has argued strenuously for a review of the program, saying improvements in cytology science and practice have long since passed by the PT regulation's 13-year-old grading scheme. The College also contends that various other aspects of the PT program, including its emphasis on individual testing, annual testing and escalating penalties, need revision.

The pending bill to suspend PT, H.R. 4568, would require the Department of Health and Human Services to revise the grading scheme and make other changes consistent with those the College has advocated. In his Dec. 22 letter to McClellan, Dr. Sodeman argued that, given the pending legislation, enforcement of PT penalties would "place laboratory professionals in the untenable position of being potentially sanctioned in 2006 based upon a grading criterion that ultimately Congress may require to be changed."

While he reaffirmed the agency's support of the PT program's controversial grading scheme, McClellan did leave open the possibility of an alternative, saying, "[I]f it is possible to craft a better testing system, and if we can work together to build consensus on the various issues raised, I will work within the CLIA statutory parameters to expedite the conversion of such ideas into reality." McClellan pledged to continue working with the College and other stakeholders to resolve the grading issue and other concerns surrounding the PT program.

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