Mammography: Capacity Generally Exists to Deliver Services
Published: 2002-04-19T00:00:00

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Highlights:
section_title: What GAO Found
paragraphs: Breast 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.

section_title: Letter
paragraphs: 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,  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.  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.
subsections: section_title: Background
paragraphs: Research studies, including eight large randomized clinical trials with 11- 20 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, 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. 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. 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.
section_title: National Capacity for Mammography Services Is Generally Adequate
paragraphs: 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.
subsections: section_title: Utilization of Mammography Services Continues to Grow
paragraphs: 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, 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.
section_title: Capacity to Provide Mammography Services Has Also Increased
paragraphs: 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.
section_title: Utilization Does Not Appear To Be Straining Capacity
paragraphs: 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). 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. 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).
In addition, while comprehensive data are not available on the total  number of radiologists available to interpret mammograms, 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).
section_title: Capacity Has Decreased in Some Locations, Causing Scattered Problems
paragraphs: 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.
subsections: section_title: Small Proportion of Counties Nationwide Lost Capacity
paragraphs: 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. 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. Thus, residents in most of the  counties that lost services appear to be able to draw on increased  resources nearby.
section_title: Counties with Largest Losses Are Mostly Rural; Most Reported No Significant Problems
paragraphs: 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. 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.  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.
section_title: Largest Service Dislocation Appears to Be Occurring in Some Metropolitan Areas
paragraphs: 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) from  a list of counties that lost the largest number of machines. All of these  counties are classified as metropolitan counties  (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. The new method includes geographic adjustments for  cost differences among areas and resulted in significant rate increases for  high cost areas.
section_title: Concluding Observations
paragraphs: 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.
section_title: Agency Comments
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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).
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.
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.
section_title: Appendix II: Comments from the Food and Drug Administration
section_title: Appendix III: GAO Contacts and Staff Acknowledgments
subsections: section_title: GAO Contacts
section_title: Acknowledgments
paragraphs: In addition to those named above, Jennifer Cohen and Stan Stenersen  made key contributions to this report.