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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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