Mammography
Capacity Generally Exists to Deliver Services Gao ID: GAO-02-532 April 19, 2002Breast cancer is the second leading cause of cancer deaths among American women. In 2001, 192,200 new cases of breast cancer were diagnosed and 40,200 women died from the disease. The probability of survival increases significantly, however, when breast cancer is discovered in its early stages. Currently, the most effective technique for early detection of breast cancer is screening mammography, an X-ray procedure that can detect small tumors and breast abnormalities up to two years before they can be detected by touch. Nationwide data indicate that mammography services are generally adequate to meet the growing demand. Between 1998 and 2000, both the population of women 40 and older and the extent to which they were screened increased by 15 percent. Although mammography services are generally available, women in some locations have problems obtaining timely mammography services in some metropolitan areas. However, the greatest losses in capacity have come in rural counties. In all, 121 counties, most of them rural, have experienced a drop of more than 25 percent in the number of mammography machines in the last three years. Officials from 37 of these counties reported that the decrease had not had a measurable adverse effect on the availability of mammography services. By contrast, in 18 metropolitan counties that lost a smaller percentage of their total capacity, officials in half of the counties reported service disruptions. Officials from six other urban areas, including Houston and Los Angeles, reported that public health facilities serving low income women had long waiting times. However, most women whose clinical exam or initial mammogram indicated a need for a follow-up mammogram were able to get appointments within one to three weeks.
GAO-02-532, Mammography: Capacity Generally Exists to Deliver Services
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United States General Accounting Office:
GAO:
Report to the Chairman, Special Committee on Aging, U.S. Senate:
April 2002:
Mammography:
Capacity Generally Exists to Deliver Services:
GAO-02-532:
Contents:
Letter:
Results in Brief:
Background:
National Capacity for Mammography Services Is Generally Adequate:
Capacity Has Decreased in Some Locations, Causing Scattered Problems:
Concluding Observations:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Comments from the Food and Drug Administration:
Appendix III: GAO Contacts and Staff Acknowledgments:
Tables:
Table 1: Changes in Total Numbers of Facilities, Machines, and
Radiologic Technologists, October 1, 1998, and October 1, 2001:
Table 2: Total Numbers of Registrants and First-Time Examinees for
Mammography Technologists, 1996-2000:
Table 3: Number of First-Time Examinees for Diagnostic Radiology
Examination, 1997 to 2001:
Table 4: Counties Randomly Selected From Those That Lost Over 25
Percent of Their Mammography Machines for Follow-up Contact, October
1, 1998, to October 1, 2001:
Table 5: Counties Judgmentally Selected From Those That Lost the
Largest Number of Mammography Machines for Follow-up Contact and the
Metropolitan Areas of These Counties, October 1, 1998, to October 1,
2001:
Abbreviations:
ARRT: American Registry of Radiologic Technologists:
CDC: Centers for Disease Control and Prevention:
CMS: Centers for Medicare and Medicaid Services:
FDA: Food and Drug Administration:
MQSA: Mammography Quality Standards Act:
NCI: National Cancer Institute:
OMB: Office of Management and Budget:
SCHIP: State Children's Health Insurance Program:
[End of section]
United States General Accounting Office:
Washington, DC 20548:
April 19, 2002:
The Honorable John Breaux:
Chairman:
Special Committee on Aging:
United States Senate:
Dear Mr. Chairman:
Breast cancer is the second leading cause of cancer deaths among
American women. In 2001, an estimated 192,200 new cases of breast
cancer were diagnosed and an estimated 40,200 women died from the
disease. The probability of survival increases significantly, however,
when breast cancer is discovered in its early stages. Currently, the
most effective technique for early detection of breast cancer is
screening mammography,[Footnote 1] an X-ray procedure that can detect
small tumors and breast abnormalities up to 2 years before they can be
detected by touch. Various groups such as the National Cancer
Institute (NCI), the American Cancer Society, and the U.S. Preventive
Services Task Force recommend regular mammograms for women age 40 and
older”the age group considered at greatest risk.[Footnote 2] Although
controversy has recently arisen about the scientific evidence
supporting these recommendations, all of these groups still maintain
that the evidence supports benefits of mammography, and on February
21, 2002, the secretary of health and human services reiterated the
government's recommendations.
Increased emphasis on providing mammography services for all women age
40 and above has raised some concerns about whether the nation's
capacity to provide these services is keeping pace with demand. Based
on the Bureau of the Census' population projections, the number of
women age 40 and older who need mammography services will increase by
more than 1 million each year. Concerned about recent media reports of
long waiting times for appointments at some locations and closures of
mammography facilities due to financial difficulty in others, you
asked us to examine several capacity issues in more detail.
Specifically, you asked us to:
* determine if the nation's capacity to provide mammography services
is adequate to meet the growing need for these services, and;
* identify geographic areas where the capacity to perform mammography
services has decreased and assess the effect of these decreases on
access to services.
To assess the adequacy of the nation's capacity, we compared the most
recent trend data on use of mammography services with the most recent
data on trends in facilities, equipment, and personnel available to
deliver these services. We generated data on utilization of services”
that is, the number of mammograms provided”from the Behavioral Risk
Factor Surveillance System, a data system administered by the Centers
for Disease Control and Prevention (CDC). The most recent data
available in the system were for 2000. Within this database, we
compared 1998 and 2000 screening rates for women age 40 and above and
used these rates to estimate changes in the number of women receiving
mammography services during these 2 years. To measure changes in the
number of facilities, machines, and radiologic technologists, we used
the latest data available from the Food and Drug Administration (FDA),
the agency with regulatory authority over mammography facilities. We
compared data on characteristics of facilities operating on October 1,
1998, with those operating 3 years later on October 1, 2001. We
analyzed these capacity changes at the national, state, and county
levels. Because data were not available to measure the effect of
changes in capacity on mammography utilization rates at the county
level, we selected 61 metropolitan and rural geographic locations
where FDA data or other reports showed a sizable decrease in capacity
and interviewed state and local officials to obtain information on
local conditions. In addition, we interviewed officials in several
professional organizations, such as the American College of Radiology
and the American Cancer Society, along with officials of FDA, CDC,
NCI, and the Centers for Medicare and Medicaid Services (CMS). Details
of our scope and methodology are presented in appendix I.
Results in Brief:
Nationwide data indicate that the nation's overall capacity to provide
mammography services is generally adequate to meet the growing demand
for these services. Between 1998 and 2000, both the population of
women age 40 and older and the extent to which they were screened
increased, resulting in a 15 percent increase in the total number of
mammograms provided to this group. The most recent data show that
between October 1998 and October 2001, the total number of machines
and radiologic technologists available to perform mammography services
had increased 11 percent and 21 percent respectively, even though the
total number of certified facilities for providing mammography
services decreased about 5 percent. While the average number of
mammograms performed per machine increased slightly, the number was
still considerably below estimates of full capacity. However, the
availability of radiologic technologists to operate mammography
machines and interpreting physicians to read mammograms may be a
concern in the future. For example, the number of first-time
candidates who sit for the examinations to qualify as a radiologic
technologist or an interpreting physician has dropped considerably
each year during the last 4 years, which has raised concerns about the
future availability of personnel.
Although mammography services are generally available, women have
problems obtaining timely mammography services in some locations. Most
of the availability problems are in certain metropolitan areas,
although the greatest losses in capacity have come in rural counties.
In all, 121 counties, most of them rural, have experienced a drop of
more than 25 percent in the number of mammography machines in the last
3 years. State and local officials from 37 of these counties whom we
interviewed reported that the decrease generally had not had a
measurable adverse effect on the availability of mammography services.
By contrast, in 18 metropolitan counties that lost a smaller
percentage of their total capacity, officials in one half of the
counties reported a variety of service disruptions. For example, an
average waiting time of up to 3 months was reported in three counties
surrounding the Baltimore metropolitan area, compared to less than 1
month in areas that reported no problems. State and local officials in
the Baltimore area said that shortages of technologists and financial
difficulties had caused many facilities to consolidate or close
resulting in a net decrease in capacity, while the demand for services
continued to increase. Officials from 6 other urban areas we
contacted, such as Houston and Los Angeles, reported that local
factors, such as having large patient loads at public health
facilities that serve low income women, can cause substantially long
waiting times at these facilities while no delays existed at other
facilities. In almost all cases, however, officials reporting problems
said that women whose clinical exam or initial mammogram indicated a
need for a follow-up mammogram generally were able to get appointments
within 1 to 3 weeks. We provided FDA with a draft of the report for
review and comment. FDA responded that it found the report to be
accurate.
Background:
Research studies, including eight large randomized clinical trials
with 1120 years of followup, indicated that widespread use of
mammography could reduce breast cancer mortality. The benefit of
mammography has recently been challenged by two Danish researchers and
an NCI advisory panel made up of independent experts; they cite
serious flaws in six of the eight clinical trials that showed
benefits. However, subsequent to the Danish report and the NCI panel's
statement, both NCI and the U.S Preventive Services Task Force
reiterated their recommendations for regular mammography screening.
While acknowledging the methodological limitations in these trials,
the U.S. Preventive Services Task Force concluded that the flaws in
these studies were unlikely to negate the reasonable consistent and
significant mortality reductions observed in these trials.
The effectiveness of mammography as a cancer detection technique is
directly tied to the quality of mammography procedures. Concerned
about the quality of mammography procedures provided by the nation's
mammography facilities, the Congress enacted the Mammography Quality
Standards Act (MQSA) of 1992,[Footnote 3] which imposed standards
effective October 1, 1994.
FDA has major oversight responsibilities, including establishing
quality standards for mammography equipment and personnel and
certifying and inspecting each facility to ensure it provides quality
services.[Footnote 4] For mammography personnel, such as radiologic
technologists and interpreting physicians, FDA specifies detailed
qualifications and continuing training requirements. Mammography
technologists are required to be licensed by a state or certified by
the American Registry of Radiologic Technologists in general
radiography, and meet additional mammography-specific training and
continuing education and experience requirements.[Footnote 5]
Similarly, FDA specifies that all interpreting physicians be licensed
in a state and certified in the specialty by an appropriate board,
such as the American Board of Radiology, and meet certain mammography-
specific medical training, as well as continuing education and
experience requirements.
FDA collects detailed information about each facility when a facility
is initially certified. FDA has established a database that
incorporates data from the certification process and from its annual
inspection program. Besides facility identification information, the
database contains information on the number of machines, personnel,
and whether the facility is active or no longer certified.
Medicare, the federal government's health insurance program for people
age 65 and above, is the nation's largest purchaser of health
services. Beginning in 1991, Medicare provided coverage of annual
mammography screening for women beneficiaries. Medicare is
administered by CMS. As a part of its health care improvement program,
since 1999, CMS and a set of contractors, called peer review
organizations, have been involved in monitoring and improving the
quality of care, including increasing mammography screening rates
among women Medicare beneficiaries.
National Capacity for Mammography Services Is Generally Adequate:
The nation's overall capacity to meet the growing demand for
mammography services is generally adequate. Between 1998 and 2000, the
use of services, as measured by the number of mammograms provided to
women age 40 and older, increased nearly 15 percent. The most recent
data on capacity show that the total number of machines and radiologic
technologists available to perform mammography services increased 11
percent and 21 percent respectively from October 1998 to October 2001.
During this same period, the total number of mammography facilities
decreased about 5 percent, indicating that facilities were
consolidating or becoming somewhat larger. The average number of
mammograms performed per machine increased slightly but was
considerably below estimates of full capacity. The one potentially
negative development is in personnel, where the number of new entrants
into the field”as measured by the number of persons who sit for
mammography technologist or diagnostic radiology examinations for the
first time”has dropped each year since 1997.
Utilization of Mammography Services Continues to Grow:
The use of mammography as a tool for detecting early cancer continues
to increase. Data from CDC's Behavioral Risk Factor Surveillance
System indicate a continuing increase in national mammography
screening rates. The proportion of women age 40 and over who had
received a mammogram within the past year increased from 58 percent in
1998 to about 64 percent in 2000. These screening rate increases,
coupled with the growth of this population,[Footnote 6] have resulted
in significant increases in the number of mammograms provided each
year. Based on CDC's data on screening rates and Bureau of Census
population data, we estimate that the total number of mammograms
received by women 40 and above nationwide has increased nearly 15
percent, from about 35 million in 1998 to more than 40 million in 2000.
These increases in mammography utilization extended across nearly
every state. Using the screening rates and the Bureau of Census
population data, we computed the number of mammograms received by
women age 40 and above on a state-by-state basis. Between 1998 and
2000, screening rates for women in this age group increased in all but
one state (i.e., Oklahoma) and the District of Columbia, and 39 states
had an increase of more than 10 percent in the total number of women
age 40 and above who had received a mammogram within the past year.
Capacity to Provide Mammography Services Has Also Increased:
The nation's capacity to provide mammography services, as measured by
the numbers of machines and radiologic technologists available to
perform mammography services, has also increased. FDA's data show that
between October 1998 and October 2001, the total number of mammography
machines and radiologic technologists available nationwide to perform
mammography services increased 11 percent and 21 percent respectively
(see table 1). While FDA's data showed that the total number of
certified facilities has decreased about 5 percent between 1998 and
2001, the average number of machines per facility increased from 1.22
in 1998 to 1.42 in 2001. Overall, the 5 percent decrease in facilities
has been offset by the 16 percent increase in the number of machines
per facility and the increase in personnel.
Table 1: Changes in Total Numbers of Facilities, Machines, and
Radiologic Technologists, October 1, 1998, and October 1, 2001:
Machines:
1998: 12,076;
2001: 13,384;
Percent change: 11%.
Technologists:
1998: 37,219;
2001: 44,857;
Percent change: 21%.
Facilities:
1998: 9,884;
2001: 9,393;
Percent change: -5%.
Note: Excludes facilities in Puerto Rico and other U.S. territories
and federal facilities operated by the Department of Defense and the
Department of Veterans Affairs.
Source: FDA database on mammography facilities.
[End of table]
Utilization Does Not Appear To Be Straining Capacity:
The current average number of mammograms actually being performed per
machine appears to be well below estimates of how many mammograms
could be performed, if equipment is operating at full capacity. While
there is no uniform standard on the number of mammograms that a
mammography machine can do in a day, FDA officials estimated that one
machine and one full-time technologist can potentially perform between
16 and 20 mammograms in an 8-hour work day, or between 4,000 to 5,000
mammograms a year (assuming 5 days a week and 50 weeks a year).
[Footnote 7] Using CDC's data on mammography screening rates, Bureau
of Census data on the population of women age 40 and older, and FDA's
data on the number of machines, we computed the average number of
mammograms performed per machine. At the national level, the average
number of mammograms per machine was 2,759 in 1998. While this average
number of mammograms per machine had increased to 2,840 in 2001, it
was still well under 4,000, the lower end range of estimated full
capacity.[Footnote 8] At the state level, the average number of
mammograms per machine in 2001 ranged from a low of 1,790 in Alaska to
a high of 3,720 in Maryland.
While the number of radiologic technologists has increased in the past
in general proportion with the increase in mammography utilization,
certain trends bear monitoring. According to an American Hospital
Association survey, the job vacancy rate for radiologic technologists
was 18 percent in 2001, and 63 percent of hospitals reported that they
had more difficulty recruiting radiologic technologists than the
previous year. Data from ARRT show the rate of increase for certified
mammography technologists through 2000 has slowed down substantially
in recent years. Similarly, the number of new entrants to the field,
as represented by the number of first-time examinees for the
mammography certificate, declined substantially each year from 1996
through 2000 (see table 2).
Table 2: Total Numbers of Registrants and First-Time Examinees for
Mammography Technologists, 1996-2000:
Year: 1996;
Registrants[A], Number: 35,943;
Registrants[A], Percent change from previous year: N/A;
First-time examinees, Number: 5,001;
First-time examinees, Percent change from previous year: N/A.
Year: 1997;
Registrants[A], Number: 39,128;
Registrants[A], Percent change from previous year: 8.9%;
First-time examinees, Number: 3,674;
First-time examinees, Percent change from previous year: -26.5%.
Year: 1998;
Registrants[A], Number: 41,536;
Registrants[A], Percent change from previous year: 6.2%;
First-time examinees, Number: 2,969;
First-time examinees, Percent change from previous year: -19.2%.
Year: 1999;
Registrants[A], Number: 42,699;
Registrants[A], Percent change from previous year: 2.8%;
First-time examinees, Number: 1,799;
First-time examinees, Percent change from previous year: -39.4%.
Year: 2000;
Registrants[A], Number: 43,718;
Registrants[A], Percent change from previous year: 2.4%;
First-time examinees, Number: 1,214;
First-time examinees, Percent change from previous year: -32.5%.
[A] The number of registrants each year does not necessarily
correspond with that of first-time examinees because the number of
registrants is influenced by the number of existing registrants who
decide to renew their certificate, the number of past registrants who
are reinstated each year, and the number of first-time examinees who
passed the examination.
Source: American Registry of Radiologic Technologists.
[End of table]
In addition, while comprehensive data are not available on the total
number of radiologists available to interpret mammograms,[Footnote 9]
the limited data available also indicate that the availability of
radiologists may bear watching. For example, data from the employment
placement service of the American College of Radiology show an
increasing ratio of job listings per job seeker for radiologists -from
1.3 in 1998 to 3.8 in 2000. Also, data from the American Board of
Radiology show that the number of first-time candidates who sit for
diagnostic radiology examination has declined each year from 1997
through 2001 (see table 3).[Footnote 10]
Table 3: Number of First-Time Examinees for Diagnostic Radiology
Examination, 1997 to 2001:
Year: 1997;
Number of examinees: 947;
Percent change from previous year: N/A.
Year: 1998;
Number of examinees: 916;
Percent change from previous year: -3%.
Year: 1999;
Number of examinees: 894;
Percent change from previous year: -2%.
Year: 2000;
Number of examinees: 863;
Percent change from previous year: -3%.
Year: 2001;
Number of examinees: 787;
Percent change from previous year: -9%.
Source: The American Board of Radiology.
[End of table]
Capacity Has Decreased in Some Locations, Causing Scattered Problems:
Because of local factors such as a shortage of personnel or closure of
certain facilities, waiting times for routine mammograms could be
several months in certain locations. Nationwide, 241 counties had a
net loss of mammography machines between October 1998 and October
2001, with 121 of them losing more than 25 percent. Our follow-up at
55 rural and metropolitan counties where reductions occurred indicated
that lengthy appointment waiting times for mammography services were
primarily in metropolitan locations.
Small Proportion of Counties Nationwide Lost Capacity:
Our county-by-county analysis of data on equipment shows that overall,
241 counties had a net loss in the number of mammography machines
between October 1998 and October 2001.[Footnote 11] Of these counties,
121 lost more than 25 percent of their machines. This number
represents counties spread throughout the nation. These counties
together contained less than 1.9 percent of the total U.S. population
in the 2000 census.
We conducted an analysis to determine what had occurred in those
counties close to the 121 counties that lost more than 25 percent of
their machines. In general, the adjacent counties showed an increase
in the number of machines, with nearly all of the 121 counties being
within 50 miles of a county that gained machines.[Footnote 12] Thus,
residents in most of the counties that lost services appear to be able
to draw on increased resources nearby.
Counties with Largest Losses Are Mostly Rural; Most Reported No
Significant Problems:
Because data are not available to measure the effect of capacity loss
on the mammography utilization rates at the county level, we randomly
selected 37 of the 121 counties that lost more than 25 percent of
their machines for in-depth analysis at the local level. These 37
counties are located in 19 states (see appendix I for a list of these
37 counties). Over three quarters of these counties are in
nonmetropolitan areas.[Footnote 13] Eighteen of the counties we
selected had one facility and 11 had no facility at all in 2001. We
interviewed state and local officials familiar with conditions in
these counties, asking them to assess the impact of the loss of
facilities.
With two exceptions, officials generally reported no significant
problems.[Footnote 14] They said existing facilities in the county or
neighboring counties were able to provide needed services, and the
longest appointment waiting time reported for routine screening
mammograms was 1 month or less, which they considered to be
reasonable. In most counties where women had to travel to neighboring
counties for services, the travel distance was less than 40 miles,
which officials considered common in rural areas. Several officials
also said that some counties were served by mobile facilities that
travel to their areas.
Largest Service Dislocation Appears to Be Occurring in Some
Metropolitan Areas:
In metropolitan counties, the picture was more mixed than for rural
counties. To examine the extent of problems in metropolitan areas, we
selected 18 additional counties (including the District of Columbia)
[Footnote 15] from a list of counties that lost the largest number of
machines. All of these counties are classified as metropolitan
counties[Footnote 16] (see appendix I for a list of these counties).
As we did for the rural counties, we contacted state and local
officials and asked them to assess the impact of the loss of machines
on women's access to services. These officials reported wide
variations in availability of services. While no problems were
reported in nine counties, officials in the other nine counties
reported a variety of problems. The nine counties with problems are
concentrated in five metropolitan areas”Baltimore, Boston, the
District of Columbia, and San Antonio and Wichita Falls, Texas. For
example, officials in three counties surrounding the Baltimore
metropolitan area reported an average waiting time of up to 3 months
for screening mammograms and 2 to 3 weeks for follow-up diagnostic
mammograms. Similarly, a survey conducted by Massachusetts officials
in April 2001 found that, in the Boston metropolitan area, appointment
waiting time for screening mammograms ranged from 1 to 20 weeks,
depending on facilities. In the District of Columbia, officials
reported that the only facility available in one part of the city had
up to an 8-week backlog of appointments, while the rest of the city
generally did not have significant problems.
In addition to contacting these 18 counties, we also contacted state
and local officials to inquire about six other urban areas”Buffalo,
Chicago, Houston, Los Angeles, New York, and Tallahassee”where no
significant number of machines was lost but problems were cited by
state and local officials or media reports. Officials familiar with
situations in these cities reported that most of the problems were
limited to certain facilities. For example, an official in Buffalo
said that one well-known facility there had a 3-month waiting list for
appointments while others could accommodate appointments within 2
weeks. In Chicago, Houston, and Los Angeles, long waiting time
problems were concentrated in public health facilities that served low
income populations. In New York and Tallahassee, long waiting times of
5 to 6 months were reported in 2000, but our recent interviews with
officials found no significant problem. In almost all cases where some
problems were reported, officials said that women who needed a
diagnostic mammogram generally were able to get appointments within 1
to 3 weeks.
Several factors have contributed to the waiting time problems in the
nine metropolitan counties and the six urban areas that we identified.
Among the reasons provided by state and local officials were the
following:
* Demand for services grew while capacity declined. In the Baltimore
area, for example, officials said that a shortage of technologists and
financial difficulty caused many facilities to consolidate or shut
down, resulting in a net decrease in capacity, while the demand for
services continued to grow.
* High demand for services at some facilities. In cities such as
Buffalo, Boston, Houston, and Los Angeles, where variation was more on
a facility-by-facility basis, officials provided various reasons for
the high demand at some facilities. For example, such factors as
facilities' reputations, physicians' referral patterns, and large
patient workload from public assistance programs cause some facilities
to have a large backlog of appointments. Some women may experience
waiting time problems because they are restricted by insurance
coverage as to where they can go for services.
* Inability to meet FDA's quality requirements. Several officials told
us that many small facilities with old machines had shut down because
they could not meet FDA quality requirements. For example, an official
from Los Angeles said that one provider had shut down three mobile
units during the last 2 years because of quality problems.
* Temporary interruptions in availability. The waiting time problems
may also be caused by the closure of one or more large facilities”a
temporary problem that often resolves itself when new facilities open
or existing facilities expand in the area. For example, lengthy
waiting problems in Tallahassee in 2000 were largely generated by the
closure of one large mammography facility but a local public
assistance program official told us in March 2002 that women in her
program could get appointments within 2 weeks as the result of a
recent opening of one new facility.
In addition to these factors, state and local officials also
frequently raised concerns about the adequacy of the Medicare
reimbursement rate, particularly in the high cost metropolitan areas.
However, during the course of our work, CMS implemented a statutory
change to the method for determining the Medicare reimbursement rate
for screening mammography.[Footnote 17] The new method includes
geographic adjustments for cost differences among areas and resulted
in significant rate increases for high cost areas.[Footnote 18]
Concluding Observations:
In general, the increase in mammography equipment and personnel has
been sufficient to meet the steady increase in demand for mammography
services. However, while the general buildup of personnel has been in
line with the growth in the use of services, the last few years show a
substantial decline in the number of new entrants to the fields, which
could result in a reversal in this trend. If this reversal occurs,
more personnel shortage problems could arise in the future.
Some instances of long waiting times for services are occurring.
Consolidation of facilities and increases in demand can create a
strain on service availability in specific communities. However,
appointment delays are primarily for screening mammograms rather than
for follow-up diagnostic mammograms. These conditions, which can be
temporary, may be exacerbated by local physicians' referral patterns,
patients' insurance coverage, or local shortages in available
personnel.
Agency Comments:
We provided FDA with a draft of the report for review and comment. FDA
responded that it found the report to be accurate and it had no other
general comments. In addition, FDA provided technical comments, which
we incorporated as appropriate. Appendix II contains FDA's written
response.
As arranged with your offices, unless you release its contents
earlier, we plan no further distribution of this report until 10 days
after its issue date. At that time, we will send copies to the
secretary of health and human services, the commissioner of FDA, the
director of NCI, the director of CDC, the administrator of CMS,
appropriate congressional committees, and other interested parties.
If you or your staff have any questions about this report, please
contact me at (202) 512-7250. Other contacts and major contributors
are included in appendix III.
Sincerely yours,
Signed by:
Janet Heinrich:
Director, Health Care”Public Health Issues:
[End of section]
Appendix I: Scope and Methodology:
To compare recent trends in the use of mammography services with
changes in facilities, equipment, and personnel available to deliver
these services, we did the following.
* We used data from CDC's Behavioral Risk Factor Surveillance System
for calendar years 1998 and 2000 (the most recent year available) to
estimate mammography screening rates for women age 40 and older on a
state-by-state basis. To estimate the number of mammograms provided to
these women in 1998 and 2000, we then multiplied these screening rates
by the population of women age 40 and over, using Census' population
estimates for 1998 and the 2000 Census population.
* We used FDA's national database on mammography facilities to assess
the change in the total numbers of certified facilities, machines, and
radiological technologists at national, state, and county levels. We
compared the characteristics of facilities operating on October 1,
1998, with those operating 3 years later on October 1, 2001. FDA
estimated an error rate of less than 1 percent for the data on
mammography facilities. We excluded facilities in Puerto Rico, other
U.S. territories, and federal facilities operated by the Department of
Defense and the Department of Veteran Affairs from the analysis.
To identify geographical areas where the capacity to perform
mammography services had decreased, and to assess the effect of these
decreases on access to services, we used FDA's national database to
identify counties that lost mammography machines and focused on those
that lost more than 25 percent of their machines from October 1, 1998,
to October 1, 2001. To determine if machines became more available in
areas close to these counties, we analyzed what had happened to the
number of machines in nearby counties. Because data were not available
to measure the effect of changes in capacity on mammography
utilization rates at the county level, we carried out follow-up
interviews with state and local officials in a random sample of 37
counties that lost more than 25 percent of their machines (see table
4).
Table 4: Counties Randomly Selected From Those That Lost Over 25
Percent of Their Mammography Machines for Follow-up Contact, October
1, 1998, to October 1, 2001:
State: Alabama;
County: Franklin;
County: Talladega.
State: Arkansas;
County: Arkansas;
County: Dallas;
County: Hempstead;
County: Mississippi.
State: Florida;
County: Suwannee;
County: Walton.
State: Illinois;
County: Jersey.
State: Indiana;
County: Daviess;
County: Jasper;
County: Putnam.
State: Kentucky;
County: Breathitt;
County: Logan;
County: Jackson.
State: Louisiana;
County: Caldwell.
State: Mississippi;
County: Madison;
County: Scott.
State: Missouri;
County: Cooper;
County: Jefferson.
State: Nebraska;
County: Cass.
State: New Mexico;
County: Chaves.
State: North Carolina;
County: Granville.
State: North Dakota;
County: Cavalier.
State: Ohio;
County: Darke;
County: Scioto.
State: Oklahoma;
County: Adair;
County: Choctaw;
County: Kay;
County: Mcclain.
State: Tennessee;
County: Greene;
County: Tipton;
County: Wilson.
State: Texas;
County: Starr.
State: Virginia;
County: Roanoke;
County: Sussex.
State: Washington;
County: Franklin.
Source: FDA database on mammography facilities.
[End of table]
Because over three quarters of these counties are in nonmetropolitan
areas, we selected an additional 18 counties (including the District
of Columbia) from a list of counties that lost the largest number of
machines (though not enough to reduce the number by more than 25
percent). All of these 18 counties are in metropolitan areas. We also
made additional inquiries about six other urban areas”Buffalo,
Chicago, Houston, Los Angeles, New York, and Tallahassee”where
problems had been cited by state and local officials or media reports.
Table 5 lists the 18 counties and their metropolitan areas.
Table 5: Counties Judgmentally Selected From Those That Lost the
Largest Number of Mammography Machines for Follow-up Contact and the
Metropolitan Areas of These Counties, October 1, 1998, to October 1,
2001:
State: Florida:
County: Orange;
- Metro area: Orlando.
State: Maryland:
County: Anne Arundel;
- Metro area: Baltimore;
County: Baltimore;
- Metro area: Baltimore;
County: Baltimore city[A];
- Metro area: Baltimore;
County: Prince George's;
- Metro area: District of Columbia.
State: Massachusetts;
County: Norfolk;
- Metro area: Boston;
County: Suffolk;
- Metro area: Boston.
State: Ohio;
County: Mahoning;
- Metro area: Youngstown;
County: Montgomery;
- Metro area: Dayton;
County: Stark;
- Metro area: Canton;
County: Summit;
- Metro area: Akron.
State: Texas;
County: Bexar;
- Metro area: San Antonio;
County: Grayson;
- Metro area: Sherman-Denison;
County: Jefferson;
- Metro area: Beaumont-Port Arthur;
County: Wichita;
- Metro area: Wichita Falls.
State: Virginia;
County: Arlington;
- Metro area: Arlington (Northern VA);
County: Richmond City;
- Metro area: Richmond.
State: District of Columbia;
County: District of Columbia[A];
- Metro area: District of Columbia.
[A] On the basis of the National Institute of Standards and Technology
(with the secretary of commerce's approval), Baltimore City, which is
independent from Baltimore County, and the District of Columbia are
considered to be equivalent to counties for legal and statistical
purposes.
Source: FDA database on mammography facilities.
[End of table]
Because no systematic data were available on waiting times and travel
distances for mammography services, we relied on observations of state
and local officials about the situations at each location. For each
selected location, both rural and metropolitan, we interviewed
officials familiar with the availability of mammography services in
these areas to obtain their views on whether women in their areas were
experiencing problems with long waiting times for appointments and/or
long travel distance to obtain services. These officials generally
included:
* state radiation control personnel contracted by FDA to conduct
annual onsite inspections of mammography facilities;
* state and local public health officials involved in CDC's Breast and
Cervical Cancer Early Detection Program, which contracts with
mammography facilities in each state to provide screening and
diagnostic mammograms to underserved women; and;
* in some locations, officials of Medicare peer review organizations
contracted by CMS to monitor and improve the quality of care,
including increasing statewide mammography screening rates for
Medicare beneficiaries.
While most of these officials have not conducted any formal studies to
gather this type of information, some have conducted informal surveys
about waiting times and others were able to provide estimates of
waiting times and travel distances through their involvement and
frequent contacts with mammography facilities.
In addition, we interviewed representatives from several professional
organizations, such as the American College of Radiology, the American
Cancer Society, and ARRT, along with officials of FDA, CDC, NCI, and
CMS. We performed our work from June 2001 through March 2002 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the Food and Drug Administration:
Department Of Health & Human Services:
Public Health Service:
Food and Drug Administration:
Rockville, MD 20857:
April 12, 2002:
Ms. Janet Heinrich:
Director, Health Care-Public Health Issues:
United States General Accounting Office:
441 G Street, NW:
Washington, DC 20548:
Dear Ms. Heinrich:
Thank you for the opportunity to review GAO's draft report,
Mammography: Capacity Generally Exists to Deliver Services (GA0-02-
532). We find this report to be accurate and well written. We have no
general comments to submit to you on this report. FDA has already
provided technical comments directly to your staff.
We appreciate your staff s attention to this important topic and the
opportunity to work with them in developing this report.
Sincerely,
Signed by:
Lester M. Crawford, D.V.M., Ph.D.
Deputy Commissioner:
[End of section]
Appendix III: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Frank Pasquier, (206) 287-4861:
Sophia Ku, (206) 287-4888:
Acknowledgments:
In addition to those named above, Jennifer Cohen and Stan Stenersen
made key contributions to this report.
[End of section]
Footnotes:
[1] Screening mammography refers to routine mammograms recommended for
women without symptoms of problems. In contrast, diagnostic
mammography refers to follow-up mammograms performed on women who had
signs, such as skin changes or abnormal screening mammograms that
indicate a need for additional evaluation.
[2] The U.S. Preventive Services Task Force is a committee of medical
experts convened by the Department of Health and Human Services to
evaluate evidence and make recommendations for screening services like
mammography.
[3] Pub. L. No. 102-539, 106 Stat.3547 (codified at 42 U.S.C.§ 263b
(1994)).
[4] These responsibilities include (1) establishing quality standards
for mammography equipment, personnel, and practices, (2) ensuring that
all mammography facilities are accredited by an FDA-approved
accrediting body and obtain a certificate from FDA in order to legally
provide mammography services, and (3) ensuring that all mammography
facilities are evaluated annually by a qualified medical physicist and
inspected annually by FDA-approved inspectors.
[5] The American Registry of Radiologic Technologists (ARRT) is the
nation's credentialing organization for radiologic technologists. It
administers an examination for certification, maintains a registry of
currently certified general radiologic technologists, and began a
subspecialty examination and certification program for mammography
technologists in 1991. FDA does not require all technologists who
perform mammography to be certified by ARRT in the mammography
subspecialty. However, the majority of the technologists who perform
mammography have such certification because almost all employers and
states that license mammography technologists have such a
qualification requirement, according to the executive director of
ARRT.
[6] In this period, the population of women age 40 and older increased
about 5 percent.
[7] FDA officials estimated that it normally takes between 20 to 30
minutes of machine and technologist's time to perform a mammogram.
Also, data from a 1992 survey conducted by NCI showed that at that
time mammography facilities reported that they could perform 20
mammograms a day if they were to operate at full capacity. FDA data
indicated that most facilities had only one machine. At 20 a day, the
yearly total mammograms per facility or machine would be around 5,000,
assuming 5 days a week and 50 weeks a year (allowing 2 weeks for
holidays and vacations).
[8] If mammography screening rates have continued to rise since 2000,
the last year for which utilization data were available, these
estimates may slightly understate the number of mammograms per machine.
[9] The only data source that contains information on radiologists
practicing mammography is the FDA database. However, we were unable to
use the database to determine the total number of radiologists
available to read mammograms. Although the database has names of
radiologists practicing at each facility, it does not uniquely
identify each radiologist and radiologists often read mammograms at
multiple facilities.
[10] Radiologists must pass a diagnostic radiology examination to
become board certified and qualified to interpret mammograms. However,
those who pass the examination may also choose to practice in other
fields of radiology other than mammography.
[11] There are 3,141 counties (including the District of Columbia)
nationwide; 241 counties lost machines, 730 counties gained machines,
and 1,334 counties had no change in machines (the remaining 836
counties had no machines in either 1998 or 2001).
[12] We measured the distance between the central points of the
counties that lost machines with the central points of the nearby
counties that gained machines.
[13] This determination is based on the 1993 rural-metropolitan
continuum codes published by the Economic Research Service of the U.S.
Department of Agriculture. These codes classify counties by
metropolitan and nonmetropolitan categories based on an Office of
Management and Budget (OMB) standard and the 1990 Census of
population. OMB defines nonmetropolitan counties as those outside the
boundaries of metropolitan areas and have no cities with as many as
50,000 residents. New codes based on the 2000 Census are not expected
to be available until 2003.
[14] An official from Chaves County, New Mexico, said that due to the
loss of one large provider, women in the county depended primarily on
a county hospital for services and the appointment waiting time for
screening mammograms was about 3 months. Women deciding not to wait
must travel 70 miles or more to facilities in neighboring counties.
However, the official said women whose clinical exams or initial
mammograms indicated a need for follow-up diagnostic mammograms
generally were able to get appointments with the county hospital
within a week. In addition, in one Oklahoma County, an official
reported long waiting times for American Indian women at tribal
facilities, although no problem was reported in that county for the
general population.
[15] Based on the National Institute of Standards and Technology (with
the secretary of commerce's approval), the District of Columbia is
considered to be equivalent to a county for legal and statistical
purposes.
[16] Based on the 1993 rural-metropolitan continuum codes published by
the Economic Research Service of the U.S. Department of Agriculture,
10 of these counties are coded as central or fringe counties with
populations of 1 million or more and 8 counties are coded as smaller
metropolitan areas with 6 having populations of 250,000 to 1 million
and 2 with populations of fewer than 250,000.
[17] Medicare, Medicaid, and SCRIP Benefits Improvement and Protection
Act of 2000, Pub. L. No.106-554. App. F, § 104(a), 114 Stat. 2763,
2763-469.
[18] Prior to January 2002, the method for determining the Medicare
reimbursement rate for screening mammography each year resulted in a
uniform rate nationwide; this payment rate was $69.23 in 2001. The
recent statutory change required CMS to include screening mammography
in its Medicare physician fee schedule. Under this fee schedule, the
annual payment amount for each service is based on a formula that
includes geographic adjustments for cost differences among areas.
Under CMS's updated fee schedule that became effective January 2002,
the Medicare reimbursement rates for screening mammography increased
significantly for high cost areas. For example, New York (Manhattan)
received a 51 percent increase (from $69.23 to $105.08) and Los
Angeles received a 30 percent increase (from $69.23 to $90.48). Lower
cost areas received less, for example, the rate in Arkansas increased
less than 2 percent (from $69.23 to $70.33).
[End of section]
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