On Saturday, a CAP lobbying and grassroots campaign won U.S. House of Representatives passage of legislation that would suspend federal cytology proficiency testing (PT) for one year and require changes consistent with those advocated by the College.

The House approved the bill, the Proficiency Testing Improvement Act of 2005 (H.R. 4568), by voice vote and sent it to the U.S. Senate, which must pass the bill before it can become law. Congress is set to adjourn within days and final action might not occur until after Jan. 1, when strict enforcment of the PT program is scheduled to begin. Laboratories are advised to adhere to the PT requirements of the current regulation and look to the College for further updates as this bill progresses through Congress.

The Proficiency Testing Improvement Act, introduced Nov. 9 by Rep. Nathan Deal, R-Ga., chair of the House Energy and Commerce Health Subcommittee, would suspend cytology proficiency testing for one year, beginning on the date of its enactment. During that suspension, the Secretary of Health and Human Services would be required to make revisions to the program, including that it:

• reflect the "collaborative clinical decision-making of laboratory personnel" who perform gynecologic cytology;
• institute "grading or scoring criteria to reflect current practice guidelines";
• require testing no more often than every two years; and
• make other revisions "as may be necessary to reflect changes in laboratory operations and practices since such standards were promulgated in 1992."

Key House members spoke in favor of H.R. 4568 during floor action Saturday, including Deal and original co-sponsor Rep. Tom Price, R-Ga. Read the text of their remarks here. Other influential House lawmakers who threw their support behind the bill included Energy and Commerce ranking member Rep. John Dingell, D-Mich.; Health Subcommittee ranking member Rep. Sherrod Brown, D-Ohio; Rep. Dave Weldon, R-Fla.; Rep. Stephanie Herseth, D-S.D.; and Rep. Michael Burgess, R-Texas, also an Energy and Commerce Health Subcommittee member.

Price, Brown, Weldon, Herseth and Burgess were among 102 House members who signed a Sept. 20 letter to Leavitt calling for an immediate suspension and review of the PT program. Leavitt, so far, has not responded to the House members' letter, and that lack of a response was cited by some members Saturday in remarks preceding passage of H.R. 4568. They also noted recommendations earlier this year by Leavitt's own advisory panel, the Clinical Laboratory Improvement Advisory Committee, that the PT program be revised to reflect current gynecologic cytology science and practice.

H.R. 4568 speaks directly to the many concerns the College and other stakeholders have raised about the 1992 cytology PT regulation since the Centers for Medicare and Medicaid Services (CMS) moved forward with the testing program last fall-more than a dozen years after the regulation became final. The College, in coalition with nearly 60 national and state pathology societies, sent Leavitt a letter June 3 detailing their concerns with the PT program, arguing that its grading scheme, emphasis on individual performance, penalties and other provisions were out-of-step with current practice or counter to the original intent of the Clinical Laboratory Improvement Amendments of 1988, the parent law of the PT regulation.

The College followed up that initiative with the congressional letter signing campaign and an intensive grassroots effort that called on CAP pathologists to urge their House members to sign the congressional letter and, later, to support the Proficiency Testing Improvement Act. CAP members responded with hundreds of calls and letters to Capitol Hill, and laboratory tours and meetings with key lawmakers in their home districts.

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Editor: Carl Graziano
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