Appeal to withdraw proposed cytology PT regulation from CAP

| March 6, 2009

CAP LogoAction Alert
From the College of American Pathologists

March 6, 2009

Your Action is Needed Today
CAP needs you to write the Centers for Medicare and Medicaid Services (CMS) today to withdraw the proposed Cytology Proficiency Testing (PT) regulation and allow alternatives to be considered. To assist you, a sample letter is available for use.

Also, instructions on how to send in your letter to CMS are provided in this communication.


On January 16th, the Centers for Medicare and Medicaid Services (CMS) released a proposed regulation making changes to the current Federal Cytology PT requirements. The CAP has been supporting an alternative model based on H.R. 1237/S. 2510, the Cytology Proficiency Improvement Act of 2007. Unfortunately, CMS’ proposed rule only makes changes at the margins and leaves in place the same flawed and punitive proficiency testing model that is not scientifically or statistically sound and bears little resemblance to Pap test practice today. Bottom line: The changes proposed in the new rule still produce a program that can't effectively measure competency, increase quality or improve women’s health. A comparison of the major provisions of the proposed regulation and the current program is provided below.

  • Require testing every two years instead of annually.
  • Require a 20 slide, four hour test instead of a 10 slide, two hour test.
  • Allow for other test mediums (e.g. computer-based virtual slides) rather than only glass slides.
  • Redefine the scoring system for pathologists and cytotechnologists, while mandating that the pathologist must still achieve a higher score to “pass.”
  • Eliminate the current biopsy confirmation requirements for Category C (LSIL).
  • Mandate laboratory director testing oversight responsibilities not currently required.
  • Impose new regulatory requirements on the use of proctors for laboratory on-site testing.
  • Bring current regulatory language for Category A (Unsatisfactory) response into conformance with Bethesda 2001 Terminology criteria for “unsatisfactory for diagnosis.”
  • Increase the number of response Category D (HSIL or cancer) cytology challenges included in a test from one under the current program to at least two challenges in the proposed test.
  • Impose a new requirement that challenges are continuously field validated throughout use of a cytology challenge.
  • Impose a new regulatory requirement mandating that the appeals process be disseminated in writing.

Sending Your Letter To CMS

To send your letter to CMS, please log onto CMS’ website. CAP has prepared a sample comment letter for your consideration and submission to CMS. The letter is based on the following points:

  • CMS has the ability to consider alternatives to the proposed rule and develop a new proficiency testing model.
  • The current and proposed changes to the regulation provide a testing model that is statistically and scientifically unsound and can’t measure individual competency.
  • The current and proposed changes to the regulation cannot demonstrate improved patient outcomes.
  • Alternative testing models should be considered that tests skills as part of an educational curriculum that includes difficult, ambiguous cases that can keep pace with advances in medicine, complement CLIA quality measures and accreditation, as well as provide for continuous quality improvement.

Action Needed

  • Log onto the CMS comment website.
  • Enter all contact information.
  • Using the “attachment function” found at the bottom of the CMS web page, attach the grassroots letter provided.


  • Cut and paste your comments into the “general comments” text field provided on the CMS web page.
  • Submit your comments before the Friday, March 17th deadline!


Please email Christopher Sherin when you have submitted your comments. We will then know which doctors have been active, so our lobbyists can follow-up on with CMS. This makes your work more effective, so please email your report.


Category: Advocacy, Government

Comments are closed.