College of American Pathologists
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March 19, 2009  •  Volume 25, Number 6
© 2009 College of American Pathologists

In This Issue:

Photo: Rep. Deal Honored with CAP-Nominated AMA Award for Government Service
CAP Urges Consideration of Alternatives To Proposed Cytology PT Regulation
Stimulus Package Delivers NIH Grants and Comparative Effectiveness Research Funds
AMA Honors Rep. Nathan Deal with Award for Outstanding Service
CAP Advocacy School Registration is Nearly Full—Signup Today
Advocacy Briefs

Photo: Rep. Deal Honored with CAP-Nominated AMA Award for Government Service

Rep. Nathan Deal (R-GA) is congratulated by Kathryn T. Knight, MD, FCAP (right) and spouse Sandra Deal (left) after being honored by the American Medical Association with the Dr. Nathan Davis Award for Outstanding Government Service March 10 at its National Advocacy Conference in Washington, D.C.

CAP Urges Consideration of Alternatives To Proposed Cytology PT Regulation

The College stated in a letter to the Centers for Medicare and Medicaid Services March 16 that the January 2009 proposed rule on federal cytology proficiency testing requirements fails to protect women’s health and called on CMS to withdraw the proposed regulation so that meaningful and more effective alternatives can be considered.

CAP has long been a critic of the current cytology proficiency testing regulation, which requires federal cytology proficiency testing for every pathologist and cytotechnologist who reads pap test specimens, because the program is not scientifically or statistically valid, cannot measure competency or improve quality.

In the letter, CAP President Jared N. Schwartz, MD, PhD, FCAP said “CAP believes the current regulation and recently proposed revisions to the federal proficiency testing requirements continue to demonstrate problems with embedding professional standards into federal regulations,” and that “CMS’s efforts to regulate in this manner have resulted in a program that fails to measure competency, is not supported by science, and does not support improved health outcomes.”

Schwartz called the current program “costly and statistically flawed…unable to test and measure proficiency, improve locator or interpretive skills, maintain pace with science and technology, or protect women’s health.”

In January 2009, CMS proposed revisions to the 1992 cytology proficiency testing regulation that would make minor adjustments such as increasing the number of Pap test challenges from 10 to 20 per test, and decreasing test frequency from once each year to once every two years.

CAP has advocated for an alternative testing model proposed in legislation that won passage in the 110th Congress House of Representatives, and garnered 43 cosponsors in the Senate before the session ended. It was also endorsed by Cytology Proficiency Improvement Coalition, a group of more than 60 organizations representing pathologists, laboratory professionals, women’s health and cancer prevention groups.

In a letter to CMS from March 17, the Coalition echoed calls to withdraw the proposed regulation and consider an alternative advocacy by CAP the Cytology Proficiency Improvement Act.

CAP, along with the Cytology Proficiency Improvement Coalition, continues to support this alternative and indicated it could be achieved through regulatory changes if CMS desires to do so.

The alternative advocated by CAP includes the following requirements:

  • All individuals involved in screening and interpreting PAP tests must participate in a federally mandated annual CMS testing program in gynecologic cytology;
  • All CMS PT programs must be approved by the Accrediting Council for Continuing Medical Education or the American Academy of Continuing Medical Education;
  • All cytology testing programs must incorporate the interpretation of Pap test with glass slides (or equivalent technologies);
  • All cytology testing programs must provide an educational opportunity to interpret a broad range of cases, including complex and ambiguous conditions;
  • Each laboratory must maintain a record of each individual’s cytology test results;
  • Each laboratory director must use results from the annual test, along with other CLIA required metrics, to assess individual performance and if necessary, take appropriate action in terms of remedial training or further continuing medical education;
  • Each lab director must share individual testing results with the lab’s accrediting organization so that individual performance can be reviewed and monitored by the accrediting organization on an ongoing basis;
  • Accrediting organizations must review the testing results as part of conducting laboratory inspections and accreditation under CLIA;
  • Each lab director must transmit assessment results and improvements to the accrediting body of the lab for quality assurance.

According to the College, if CMS were to withdraw the proposed regulation and work with stakeholders to take a fresh look at the CLIA statute, the regulatory attributes of CAP’s alternative could provide the foundation for a bona fide regulatory model.

To view CAP’s complete comments, please visit the Advocacy website under Comments to Regulatory Agencies.

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Stimulus Package Delivers NIH Grants and Comparative Effectiveness Research Funds

Building healthcare infrastructure and supporting research have emerged as top priorities in the Obama stimulus package.

The National Institutes of Health has unveiled new grants funded by the American Recovery and Reinvestment Act of 2009, aimed at supporting science and research while stimulating the economy.

The $1.5 billion in NIH infrastructure and research funds provided by the stimulus package, signed by President Obama Feb. 17, are separate from the $19.2 billion included for Medicare incentive payments for physicians and hospitals to adopt Health Information Technology, as previously reported in Statline.

The NIH will allocate the Recovery Act funds as follows:

  • At least $200 million in Challenge Grants to support research on topics that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant two-year jumpstart funds;
  • $1 billion in construction grants to help build new or improve existing research facilities and help grow the economy;
  • $300 million in shared instrumentation grants to facilitate the purchase of research equipment that will enable scientists and researchers to complete their critical work.

In addition, the National Institutes of Health also was allocated $10.4 billion for scientific research, construction and improvement of research facilities, as well as the purchase of scientific equipment; the majority of these funds will be for extramural research.

The stimulus package also provides $1.1 billion for Comparative Effectiveness Research (CER), part of which is allocated to a new federal council.

The Agency for Healthcare Research and Quality will receive $700 million of the $1.1 billion for CER, and must transfer an additional $400 million to National Institutes of Health.

The newly created federal CER council, the Federal Coordinating Council for Comparative Effectiveness Research, will be an advisory board comprised solely of representatives of federal agencies charged with coordinating federal research on CER.

Its mission will be to make recommendations to the Secretary of the Department of Health and Human Services concerning CER infrastructure and fund allocation, as well as provide annual reports to the President and Congress on infrastructure needs and opportunities for better coordination between agencies.

For more information on the National Institute of Health’s infrastructure and research grants, please visit their website.

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AMA Honors Rep. Nathan Deal with Award for
Outstanding Service

The American Medical Association honored Rep. Nathan Deal (R-GA) with the Dr. Nathan Davis Award for Outstanding Government Service March 10 at its National Advocacy Conference in Washington, D.C.

The College of American Pathologists nominated Representative Deal due to his numerous contributions in improving patient safety, advancing a health care quality agenda and safeguarding programs that ensure public health.

“Mr. Deal’s talent for developing innovative solutions to complex health care challenges has promoted the art and science of medicine,” said Jared N. Schwartz, MD, PhD, President of the College of American Pathologists. “As an advocate for high quality health care, he has earned the respect of his colleagues and we believe that this national recognition is one he richly deserves.”

The Dr. Nathan Davis Awards for Outstanding Government Service are recognized nationally as one of the most prestigious honors extended to elected officials and career government employees for outstanding endeavors that advance public health.

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CAP Advocacy School Registration is Nearly Full—Signup Today

If you’ve ever been tempted to get more involved in healthcare policy, now is time to sign up for Advocacy School 2009 in Washington, D.C., May 4 - 6.

Attendees receive in-depth political advocacy training, learn about the College’s key issues and the legislative process, hear from Congressional guest speakers and meet with lawmakers and their staff. The College covers all expenses.

Registration for 2009 Advocacy School is nearly full, we urge you to act fast and register today.

If you would like to attend the CAP Advocacy School this spring, or have any further questions, please contact Susan Askew by e-mail or at 202-354-7105.

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Advocacy Briefs

Gubernatorial Lab Tours

Stephanie Mayfield-Gibson, MD, FCAP, hosted a lab tour for Governor Steve Beshear of Kentucky, on Friday, March 6 at Kentucky Public Health Labs in Frankfort, KY.For more information on how you can host a laboratory tour, contact Chris Sherin either by phone, 202-354-7129, or email.




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