Improvements in Highly Successful Pap Test for
Cervical Cancer Pushed by Medicare
Medicare paid approximately $34.2 million for over
a million screening Pap tests in 2007
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Read more
about Cervical Cancer in sidebar below, "Silent Cancer.." |
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Jan. 19, 2009 What is one the most successful
screening test ever adopted and one the first to be covered by Medicare,
the Pap test for cervical cancer may become even more effective with
regulatory changes aimed at assuring the competency of those conducting
the test.
The Centers for Medicare & Medicaid Services (CMS)
last week announced proposals to further improve the most common
screening test for cervical cancer, the Papanicolaou test, which is more
commonly known as the Pap test.
The proposed rule would update the current
regulatory provisions that were promulgated under certain provisions of
the Public Health Service Act. These provisions require certain
physicians (pathologists) and cytotechnologists (laboratory
technologists with special training in the formation, structure, and
function of cells) who screen Pap tests to demonstrate their proficiency
in reading and interpreting Pap test specimens.
Soon after Pap screening became available, the
number of women dying from cervical cancer dropped nearly 75 percent,
and today, with improved testing and treatment procedures, a woman who
is diagnosed in the early stages of the disease has a 92 percent chance
of being alive five years later, said CMS Acting Administrator Kerry
Weems.
The Pap tests impact was so dramatic that it was
one of the first screening procedures to be granted coverage under the
Medicare law.
Today, far from being a leading cause of death for
women in the United States, fewer than 4,000 die each year from cervical
cancer. While deaths from cervical cancer have been greatly reduced
through the use of Pap testing, further improvement is needed as the
death rate for minority women is twice that of white women.
Over the years, Congress has repeatedly recognized
the importance of Pap testing.
Concerns about erroneous Pap test results were one
of the major impetuses behind the enactment of the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), the first major overhaul of
federal regulation of clinical laboratories since enactment of the
original Clinical Laboratory Improvement Act of 1967.
The new law extended Federal regulation beyond
laboratories that sent and received specimens through interstate
commerce to all laboratories in which clinical testing occurs for the
purposes of diagnosis or treatment of a medical condition. It
established minimum quality standards for nearly all clinical laboratory
testing in the United States from simple tests performed in a doctors
office to the most complex testing performed in large independent
laboratories and academic medical centers.
Two years later, to improve access to screening,
Congress passed the Breast and Cervical Cancer Mortality Prevention Act
of 1990, which led to the creation of the National Breast and Cervical
Cancer Early Detection Program in 2000 within the Centers for Disease
Control and Prevention (CDC).
In 2000, Congress passed the Breast and Cervical
Cancer Prevention and Treatment Act, giving states the option to cover
screening for these cancers under their Medicaid programs.
The U.S. Preventive Services Task Force, an
independent task force administered by the Agency for Healthcare
Research and Quality (AHRQ), gives its highest rating (A) to its
recommendation for routine Pap testing as a measure to prevent cancer
deaths.
While Medicare paid approximately $34.2 million for
over a million screening Pap tests in 2007, the test may be even more
important to public and private programs that serve women of
child-bearing age, who are at greater risk of cervical cancer.
The proposed rule would enhance and clarify CLIAs
proficiency testing requirements for Pap testing. While CLIA provides
for proficiency testing of laboratories in other specialties, it
requires that proficiency testing for cytology laboratory personnel
(those reading Pap tests) be scored for each individual.
This is because this kind of screening requires
intense concentration by the cytotechnologist/pathologist as they
examine the cells in the Pap test under a microscope, and poor skills in
reading the test (which is generally only read by one individual unless
an abnormality is noted) can have a direct and significant impact on
patient outcomes.
Due to the difficulty of developing an appropriate
proficiency testing program for Pap tests, the cytology proficiency
testing requirement was not implemented on a nationwide basis until
2005. The proficiency testing results from the first three years of
this nationwide testing have demonstrated the importance of the program
in ensuring quality and improving proficiency.
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A Silent Cancer
Unlike many cancers that cause pain, noticeable
lumps, or other early symptoms, cervical cancer has no telltale symptoms
until it is so advanced that it is usually unresponsive to treatment.
Symptoms may even be absent at that point, although they often include
abnormal vaginal bleeding, such as following intercourse or douching,
between menstrual periods, or after menopause. Only in its late stages
does cervical cancer cause pain in the lower abdominal or back regions.
But because the cervix, or neck of the uterus, can
be easily accessed through the vagina, doctors can test for cervical
cancer as well as for precancerous changes in the cervix. Most cervical
cancers grow slowly over several years and often are preceded by
abnormal cells. Cervical cancer can often be prevented by the removal of
these abnormal cells.
To detect abnormal or cancerous cervical cells,
George Papanicolaou, M.D., Ph.D., of Cornell University developed in the
1940s what is known today as the Pap test. In this test, a sample of
cells is taken from in and around the cervix with a wooden scraper,
cotton swab, or small cervical brush. The specimen is smeared on a glass
slide, preserved with alcohol, and then sent to a laboratory. There
cytotechnologists, specially trained in identifying abnormal cells,
scrutinize the cervical cells under the microscope for any abnormal
features associated with cancerous or precancerous cervical cells. These
features include dark or irregularly shaped cell nuclei, or small or
deformed cells.
The Pap test became a routine part of gynecological
exams. As a result, there was a 70 percent drop in the number of women
dying from cervical cancer between 1950 and 1970, according to the
National Cancer Institute. But the problem of errors remained. Such
errors are understandable when considering the magnitude of the task set
before the cytotechnologist examining Pap slides. These standard-sized
laboratory slides are lined with between 50,000 to 300,000 cervical
cells. Lurking in these cells may be as few as a dozen abnormal cells.
Finding such telltale cells is akin to finding a needle in a haystack,
especially at the end of the day when cytotechnologists are likely to
have examined nearly 100 Pap slides. In addition, abnormalities in cell
shape may be slight and difficult for even the trained eye to detect, or
may be masked by infection.
Article from FDA Consumer Magazine, updated
1997
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For example, failure rates on the initial test of
each annual testing cycle dropped from 33 percent in 2005 to 11 percent
in 2007 for pathologists reading slides without the assistance of a
cytotechnologist. Nonetheless, given the consequences of false Pap test
results, the current level of failure is still of great concern to CMS.
During the same period, the failure rates dropped
from 10 percent to 3 percent for pathologists reading slides with the
assistance of a cytotechnologist, and from 7 percent to 3 percent for
cytotechnologists reading slides alone under the supervision of a
pathologist.
Each individual who undergoes cytology proficiency
testing is given four opportunities (an initial test and up to three
retests) within each testing cycle to pass the test. To improve the
statistical validity of the proficiency test the proposed rule would
increase the number of slides or other approved test media
("challenges") from 10 to 20 for the initial test and first retest.
This is the number of challenges currently required for second and third
retests.
While the proposal would increase the number of
challenges in the initial test and the first retest, it would reduce the
overall burden on those conducting Pap testing by decreasing the testing
frequency from annually to biennially.
The proposed rule would modify requirements
regarding the design and scoring scheme of the Pap test proficiency
testing, in part to account for the greater number of slides to be read
in the initial test and first retest.
The proposed rule would also improve the appeal
process and impose new requirements on CMS-approved providers of Pap
test proficiency testing to improve the testing process. In addition,
CMS is requesting additional information from cytology PT providers and
others to analyze trends in PT failures over time.
The proposed changes are largely the result of
recommendations from the Clinical Laboratory Improvement Advisory
Committee (CLIAC), an advisory committee established by the Department
of Health and Human Services (HHS) to promote ongoing improvement in
clinical laboratory oversight.
The CLIAC is comprised of experts from the
laboratory community and other stakeholders, as well as representatives
from CMS, CDC, and the Food and Drug Administration (the three agencies
within HHS that share responsibility for implementing the CLIA
program). CMS has also sought input from the wider laboratory community
affected by this testing and has worked in collaboration with the CDC in
developing this proposed rule. We are soliciting comments from the
public in the areas where changes are proposed.
Even with the most highly skilled testing
personnel and the best diagnostic and treatment tools, it will not be
possible to prevent all cervical cancer deaths, said Weems, but no
woman should die because someone failed to read a screening test
correctly.
We believe the proposed changes to the cytology
proficiency testing requirements will continue to protect womens health
while reducing the regulatory burden on the pathologists and
cytotechnologists who screen Pap tests.
Comments on the proposed rule will be accepted
until March 17, 2009. After carefully considering the comments it
receives, CMS, in collaboration with the CDC, plans to issue a final
rule.
More information on CLIA and a copy of the
proposed rule are available on the CMS website at:
www.cms.hhs.gov/center/clinical.asp.
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CMS Fact Sheet |
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Proposals to Improve Cytology
Proficiency Testing Required by the Clinical Laboratory
Improvement Amendments of 1988
OVERVIEW:
On January 15,
2009, the Centers for Medicare & Medicaid Services (CMS) issued
a proposed rule that would improve the requirements for
proficiency testing (PT) for individuals who screen and
interpret Papanicolaou (Pap) tests to identify cervical cancers
at an earlier, more treatable stage. The proposals would
affect approximately 12,500 pathologists and cytotechnologists
who review 60 million Pap tests in the
United States
annually. In developing the proposed rule, CMS worked closely
with the Centers for Disease Control and Prevention (CDC), which
along with the Food and Drug Administration (FDA), share
responsibility for improving clinical diagnostic laboratory
testing in the United States.
Prior to the
widespread adoption of Pap testing, cervical cancer was the
leading cause of death for women in the
United States
. With early detection and treatment, the number of deaths has
dropped dramatically, and today, the five-year relative survival
rate for the earliest stage of invasive cancer is 92 percent.
More information about the history and current status of
cervical cancer diagnosis and treatment is attached as Appendix
A.
The proposed
changes to the regulatory requirements under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) for cytology
proficiency testing would improve the efficiency and
effectiveness of cytology PT and reduce the regulatory burden on
laboratories that perform this screening by decreasing the test
frequency from annually to biennially.
BACKGROUND:
Deaths from
incorrectly read Pap tests were a major impetus for the passage
of CLIA just over 20 years ago. CLIA regulates nearly all
clinical laboratories that conduct testing for medical purposes
in the
United States
. Concerns about the quality of Pap testing and the potentially
deadly impact of an incorrect Pap test result led Congress to
establish certain unique regulatory requirements for those
conducting Pap testing. Recognizing that it takes highly
skilled and trained pathologists and cytotechnologists to screen
cellular specimens from the female reproductive tract for early
signs of cancer, Congress specified that each individual
involved in screening or interpreting Pap tests was to be
required to demonstrate proficiency through participation in an
approved proficiency testing (PT) program. This PT is designed
to test the individuals ability to locate and identify what may
be only a few abnormal cells out of thousands of cells on a
slide.
CURRENT
CYTOLOGY PT PROGRAM:
Cytology PT
was implemented nationwide in 2005. There are currently two
CMS-approved cytology PT programs that operate nationwide from
which laboratories may choose: one offered by the American
Society for Clinical Pathology (ASCP) (which is a continuation
of the PT program originally approved to be run by the Midwest
Institute for Medical Education, Inc. (MIME) in 2005) and
another offered by the College of American Pathology (CAP),
which was approved to begin testing in 2006. A third program
run by the State of Maryland was approved by CMS to begin
testing in 1995 but is limited to laboratories screening Pap
tests from residents of Maryland.
While CLIA
provides for PT of laboratories in other specialties, the PT for
cytology (Pap) testing requires the periodic testing of the
individual pathologist or cytotechnologist (a laboratory
technologist with special training in cytology) who screens or
interprets gynecologic samples in Pap tests). This requirement
recognizes that intense concentration is needed to examine the
cells in a Pap test and that most Pap tests are screened by a
single individual, without a second level review. Under the
CLIA regulations, the individual taking the test is given at
least four chances in a testing cycle (currently annual, but
proposed to be biennial) to achieve a passing score of 90
percent.
Currently, for
both the initial test and the first retest, the individual is
required to screen 10 slides within two hours. For the second
and third retests (where necessary), the number of slides is
increased to 20 and the time for completing the screening is
increased to four hours. An individual who does not score at
least 90 percent on the initial test may continue to screen
slides, but must retake the test. If the individual does not
score at least 90 percent on a second test, he or she may
continue screening slides but the results must be confirmed by a
colleague who has passed the test during the current calendar
year. The individual must also undergo additional training and
take a third test and obtain a score of at least 90 percent.
Only after failing to obtain a score of 90 percent on the third
test is the individual precluded from performing further
screening of patient samples until he or she has obtained 35
hours of continuing education and achieved a score of at least
90 percent on a 20 slide retest.
Under current
rules, missing even one high grade lesion or cancer case will
result in automatic failure.
EXPERIENCE
DURING FIRST THREE YEARS OF PT PROGRAM:
Over the three
years that the nationwide cytology PT programs have been in
effect, the percentage of personnel who pass the test on the
first attempt has steadily increased. This is true without
regard to whether the individual taking the test is a
pathologist screening slides without the assistance of a
cytotechnologist, a pathologist screening with the assistance of
a cytotechnologist, or a cytotechnologist screening alone under
the supervision of a pathologist. The improvements seen in the
results for pathologists who screen slides without the
assistance of a cytotechnologist have been the most striking.
In 2005, 33 percent of pathologists screening slides without the
assistance of a cytotechnologist failed their initial test; by
2007, the failure rate for this group on the initial test
dropped to 11 percent.
PROPOSALS
IN THIS NOTICE OF PROPOSED RULEMAKING:
In response to
concerns expressed by the cytology testing community, CMS is
proposing to refine the cytology PT program in a number of ways,
based on recommendations provided by cytology experts. For
example, the proposed regulation would increase the number of
slides or other approved media (challenges) in the first test
and first retest to 20, and the time for completing the
screening to four hours. The score required to pass would
remain at 90 percent, but by doubling the number of challenges,
each error would have only half as much impact on the total
score. Missing two high-grade lesions or cancers would result
in automatic failure. The proposed rule would also require PT
testing biennially rather than annually as in the current
rules. The proposed rule also provides for the approval of
media other than glass slides for cytology PT to accommodate the
use of future PT technologies.
The proposed
rule would also affect the providers of cytology PT, by
requiring them to explain their appeals process prior to the
administration of a test and imposing more stringent obligations
on PT programs to maintain high quality testing sets. The
proposed rule requests additional information from cytology PT
providers and others to analyze trends in PT failures over
time. A chart comparing the key differences between the current
regulation and the proposed regulation is attached as Appendix
B.
Comments on
the proposed rule will be accepted until March 17, 2009. After
carefully considering the comments it receives, CMS, in
collaboration with the Centers for Disease Control and
Prevention (CDC), plans to issue a final rule.
More
information on CLIA and a copy of the proposed rule are
available on the CMS website at:
www.cms.hhs.gov/center/clinical.asp.
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