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BREAST CANCER
RADIO ADDRESS
86:23 FROM:WOMENS OFFICE
502-455-7311
10:65507
PRGE:01
united HOUSE
WASHINGTON
OFFICE FOR WOMEN'S INITIATIVES AND OUTREACH
TO: Sara Bianchi
FAX: 6-5557
DATE: 10/23
NUMBER OF PAGES (Including cover sheet): $ 22
FROM:
Audrey Tay3e Haynes, Director
Sondra Seba, Agency Representative
Robin Leeds, Agency Representative
Other
NOTES:
FINAL Briefing
paper - Bulmail
of members attending.
THE WHITE HOUSE
OFFICE FOR WOMEN'S INITIATIVES AND OUTREACH
708 JACKSON PLACE, NW
WASHINGTON, DC 20503
PHONE: (202) 456-7300 FAX: (202) 456-7311
The information contained in this facsimile message is CONFIDENTIAL and intended for
the recipient ONLY. PLease call If there are any problems with this transmission.
PRESIDENT AND THE FIRST LADY ANNOUNCE NEW INITIATIVES TO IMPROVE
PREVENTION AND EARLY DETECTION OF BREAST CANCER
Embargoed Until October 25, 1997
Today the President and the First Lady announced new steps to ensure that more women get
regular, high quality mammograms. Early detection, followed by prompt treatment, can reduce
the risk of death by as much as 30 percent. However, a mammogram can fail to do its job because
of poor medical techniques, processing or reading of the films; inadequate record keeping and
reporting of results, and lack of effective quality assurance controls. In 1995, about 35 percent of
mammography facilities that sought accreditation initially failed the quality requirements.
Moreover, far too few women get regular mammograms. Thirty-three percent of women ages 50
to 64, and 45 percent of women over age 65 reported not receiving a mammogram in the last two
years. The initiatives the President and the First Lady are announcing today include:
Improving Quality Standards of the Mammography Facilities Nationwide. The new FDA
regulations announced today, authorized by the Mammography Quality Standards Act (MSQA),
set new high standards for mammography facilities. They include important new clarifications
that require facilities to hire capable technologists, to use equipment that produces clear and
accurate images, and to ensure that physicians have the skills to interpret the rules. It also requires
facilities to display their FDA certification, so women and their families know they have met the
quality standards. They also require that patients be fully informed of results of a mammogram SO
that follow up testing and treatment can begin immediately. These new standards will ensure
women receive high quality, accurate mammograms. The National Breast Cancer Coalition
applauded the implementation of the final regulations stating that "this Rule will ensure that every
woman in America will receive the highest quality mammography."
Initiating a New Mammography Education Campaign at the National Cancer Institute
(NCI). Today, the NCI is initiating a new national education campaign that provides women and
their families and health professionals clear, up-to-date information about steps they should take to
detect mammography and breast cancer. The materials being released have been developed to
educate women about the recommendations made by NCI this spring that women in their 40s and
older should get regular screening mammograms. The NCI materials will be released to
community organizations, doctor's offices, and other health care facilities around the country,
providing education about the risk factors for breast cancer, the benefits and limitations of
mammography, and the importance of regular mammograms for women in their 40s and older.
They also highlight breast cancer incidence and mortality rates for women in different racial/ethnic
groups.
Launching the First Lady's National Annual Medicare Mammography Campaign. Each year the
First Lady has launched a mammography campaign to encourage older women to get mammograms.
Despite the fact that mammography can significantly reduce mortality rates, 45 percent of women over
age 65 have not had a mammogram in the last two years. To encourage more older women to get regular
mammograms, this year the First Lady's campaign includes:
New Nationwide Public Service Announcements to Encourage More Older Women to Get
Mammograms. Today, the First Lady is announcing two new public service announcements to
encourage older women to get mammograms. One of the PSAs features Candice Bergen and was
aired this week at the close of the Murphy Brown Show. The second PSA includes breast cancer
survivor and spokesperson Carol Baldwin and her sons, Alec, William, Daniel and Stephen. In
addition to these PSAs, a number of corporations have made important new commitments to
educate women about the importance of regular mammography and screening.
HORIZON Grants to Improve Mammography Rates Among Minority Women. This year
HCFA has focused the Medicare mammography campaign to reach minority Medicare
beneficiaries who are even less likely to get mammography screenings. HCFA launched Horizon
Project grants, a three-year initiative in six major cities which focuses efforts on increasing
mammography rates among Hispanic and African-American Medicare beneficiaries. These
comprehensive efforts will not only encourage more women in these areas to get regular
mammograms but provide insight on how to overcome barriers that prevent women from getting
mammograms. This week, we received the project's first report, and it is teaching us a great deal
about how to identify barriers including lack of awareness about the Medicare mammography
benefit, language barriers, and misconceptions that only women of childbearing are at risk for
breast cancer, and strategies to overcome them.
The Initiatives Being Announced Today Build on the President's Strong Record in the Fight
Against Breast Cancer.
The Balanced Budget Act Made Medicare Mammograms More Affordable and Accessible.
The balanced budget the President signed into law this summer took steps to encourage more
women to get regular mammograms by waiving deductibles for all mammograms and covering
mammograms on an annual basis. Although Medicare has covered screening mammography since
1991, only 14 percent of eligible beneficiaries without supplemental insurance receive
mammograms, indicating that cost can be a significant barrier. The balanced budget also
expanded coverage to pay for annual screening mammograms all Medicare beneficiaries age 40
and over making coverage consistent with the new recommendations of national experts.
Earlier in the year, President Clinton took action to bring Medicaid and Federal Employees Health
Benefits in line with the new recommendations.
The President Has a Long Record in Fighting Breast Cancer. The President has taken a
number of important steps to fight breast cancer. Since the President took office funding for breast
cancer research, prevention and treatment has nearly doubled to over $500 million in 1997; the
CDC breast and cervical program which provides screening low-income women has expanded
nationwide; new space technology has been applied to research to gain valuable knowledge
important about detection and treatment of breast and ovarian cancer; and funding has increased
for an unprecedented partnership at the Department of Defense between the military, scientists,
physicians and community members for grants to invigorate breast cancer research.
CLINTON ADMINISTRATION INITIATIVES TO FIGHT BREAST CANCER
Introduced Legislation to Prevent Discrimination Based on Genetic Information.
The President has urged Congress to pass bipartisan legislation to prohibit health plans
from inappropriately using genetic screening information to deny coverage, set
premiums, or to distribute confidential information. For many diseases, such as breast
cancer, we are beginning to identify hidden genetic disorders which can spur early
treatment. However, genetic testing also can be used by insurance companies and others
to discriminate and stigmatize groups of people. In fact, studies show that a reason
women do not get genetic testing for breast cancer is because they fear the information
will be used to discriminate against them.
Expanded Medicare to Pay for Annual Screening Mammograms for all Medicare
Beneficiaries Age 40 and Over. The balanced budget expands coverage to pay for
annual screening mammograms for all Medicare beneficiaries age 40 and over, enabling
women to follow the National Cancer Institute's (NCI) recommendations to undergo
regular mammogram screening at age forty. President Clinton has also taken action to
bring Medicaid and federal employee health benefits in line with NCI recommendations.
Made Medicare Mammograms More Affordable and Accessible. The balanced
budget enacted by the President this August waived deductibles for all screening
mammograms, making annual mammograms more affordable for older women. Costs
can be a significant barrier for older women to get mammograms. Although Medicare
has covered screening mammography since 1991, only 14 percent of eligible
beneficiaries without supplemental insurance receive mammograms.
Built on HHS Commitment to Breast Cancer Research, Prevention and Training.
Since the President took office, funding for breast cancer research, prevention and
treatment has nearly doubled, from about $276 million in FY 1993 to an estimated $513
million in the President's FY 1997 budget.
Continued Department of Defense Funding for Breast Cancer Research. In FY
1997, the DOD will spend $112 million on breast cancer research. This is an
unprecedented partnership between the military, scientists, physicians, and the
community to fund grants to invigorate breast cancer research. One of the most
important and innovative aspects of the program is that breast cancer survivors are
actively engaged in defining the program and serve on scientific panels which review
grant proposals.
Increased Funding for Genetic Research. HHS-funded research led to the discovery of
two breast cancer genes BRCA-1 and BRCA-2 -- which holds great promise for the
development of new prevention strategies. On October 26, 1996, President Clinton
announced $30 million in new funding for research into the genetic basis of breast cancer.
Educated Older Women to Use the Medicare Mammography Screening Benefit.
The First Lady has launched a yearly mammography campaign to inform and encourage
older women to use the Medicare mammography screening benefit. Despite evidence
that early detection through mammography and clinical breast exams is essential, 45
percent of women over age 65 report they have not had a mammogram during the past
two years. This year the First Lady's campaign focuses on encouraging women with
particularly low mammography utilization rates to get mammograms.
Improved Mammography Quality Standards. The final regulations the President
announced today strengthen and improve the program the FDA implemented for
mammography standards in 1994 to ensure that they meet standards for equipment,
personnel, record-keeping, and quality control. Women and their families can look for
the FDA certificate as evidence that the facility meets quality standards. These new
standards will ensure women high quality, accurate mammograms. Women can find a
certified mammography facility by calling 1-800-4-CANCER.
Supported Legislation That Prevents Women From Being Forced Out of the
Hospital Only Hours After a Mastectomy. In his State of the Union Address, President
Clinton endorsed bipartisan legislation to ensure that women are not forced out of the
hospital before they are ready because of pressure from their health plan. The
Department of Health and Human Services also sent a letter to all Medicare managed care
plans making it clear that they may not set ceilings for inpatient hospital treatment or set
requirements for outpatient treatment, and that a woman and her doctor should make
decisions about what is medically necessary.
Provided Screening for Low-Income Women. CDC's National Breast Cervical Cancer
Early Detection Program offers free or low-cost mammography screening to low-income
elderly and minority women. On October 1, 1996, Secretary Shalala announced the
expansion of the program to all fifty states. The goal is to reduce breast cancer deaths
among these women by 30% and cervical cancer deaths by 90% through increased
mammography and pap testing.
Applied Space Technology to Detect and Treat Breast Cancer. NASA is applying
cutting edge technology to improve ways to diagnose and treat breast cancer. For
example, NASA uses the microgravity of space to grow human tissue for research and
transplantation, gaining valuable knowledge important to the treatment of breast and
ovarian cancer. Mars Pathfinder technology has been developed to enhance pictures is
being modified to make three-dimensional models of breast tissue. This enables doctors
to differentiate breast tissue more accurately without using painful invasive procedures.
QUOTES SUPPORTING THE PRESIDENT'S INITIATIVES ON BREAST CANCER
"Thank you for your continuing commitment to eradicating breast cancer. Over the past five
years, your Administration has helped make finding the cause of and a cure for breast cancer a
national priority by increasing research efforts and improving current breast cancer policy."
"We applaud the Administration's dedication to improving breast cancer screening and the
promulgation of the final regulations implementing the Mammography Quality Standard Act
(MQSA). This Rule will ensure that every woman in America will receive the highest quality
mammography."
--National Breast Cancer Coalition
"The American Cancer Society (ACS) applauds President Clinton for his leadership on breast
cancer issues. ACS supports the issuance of the final regulation of the Mammography Quality
Assurance Standards Act (MQSA) because it will give women more confidence in the quality of
their mammography."
" ACS also supports the investment in screening programs to reach poor and underserved women
who may not otherwise receive health care."
" Finally, ACS supports the National Cancer Institute initiative to educate women about the need
for annual mammograms beginning at age forty."
--American Cancer Society
"On behalf of the National Alliance of Breast Cancer Organizations' 375 member organizations
and the many thousands of women under their care, please accept our appreciation for your
leadership in the fight against breast cancer. With new plans and initiatives and through support
of federal programs and legislation, all American families have felt your concern about this most
common form of cancer in women in our country."
"With your guidance, millions of women are now hearing lifesaving messages, and poor and
underserved women are linked to health care services they require and deserve."
--National Alliance of Breast Cancer Organizations
"I am pleased to join millions of other Americans in applauding your leadership in all areas of
women's health, especially breast cancer detection and treatment."
"Your initiatives to broaden access to mammography for all American women and to ensure that
mammograms are done only by trained personnel at properly equipped facilities will
undoubtedly save many lives."
" We also applaud your efforts to increase funding for breast cancer research."
--Society for the Advancement of Women's Health Research
"The American College of Radiology (ACR) today strongly supported the Administration's far-
reaching efforts to bring high quality screening mammography to under-served women across the
nation."
"As a result of this private/public partnership with the ACR accreditation program and FDA
certification women can be assured of getting the best mammography available, which can save
their lives through early detection."
--American College of Radiology
"The American Medical Women's Association applauds the efforts of the Clinton
Administration in the area of breast cancer research, education, detection, diagnosis, and
treatment."
"As a long-time advocates for women's health, President and Mrs. Clinton are to be commended
for their support of the FDA's Mammography Quality Standards Act, which ensures that all
mammography facilities in the United States are certified by the FDA as providing quality
mammography in order to lawfully continue to provide mammography services."
--American Medical Women's Association
"I want to commend you for your leadership of a national effort to combat breast cancer."
"The efforts of your Administration to expand Medicare coverage of mammograms are critical if
elderly women are to take advantage of this important screening tool. Of equal significance is
making women aware of the need for mammograms and that coverage is available."
--American College of Obstetricians and Gynecologists
"Shaklee applauds the efforts of Hillary Clinton and the Clinton Administration to change
Medicare guidelines to allow women over 50 access to annual mammogram testing."
--Shaklee Corporation
496- 3934
THE WHITE HOUSE
WASHINGTON
RADIO ADDRESS ON BREAST CANCER AWARENESS AND
THE MAMMOGRAPHY INITIATIVE
DATE:
Friday, October 24, 1997
TIME:
4:30 PM 9 5:00 PM
LOCATION: Oval Office
FROM:
Maria Echaveste
Audrey Tayse Haynes
Barbara Woolley
Brenda Anders
L
PURPOSE
In conjunction with National Breast Cancer Awareness Month, you will announce new
regulations that will dramatically improve the quality of mammography screening and will
launch an unprecedented mammography education campaign by the National Cancer
Institute. The First Lady will launch her annual Medicare mammography campaign to
encourage older women to get regular mammograms. Ai this event, the First Lady and
Secretary Shalala will also introduce two new Public Service Announcements that are
being released to encourage older women to get mammograms.
II.
BACKGROUND
October is National Breast Cancer Awareness Month and the 27th anniversary of the
National Cancer Act. You will be making two announcements today: 1) releasing the final
regulations for the Mammography Quality Standards Act (MQSA) which will assure that
women are receiving quality mammograms by trained medical personnel at properly
equipped facilities, and will require patients to be fully informed of results so that follow
up testing and treatment can begin; and 2) a mammography campaign by NCI to educate
women and health providers about mammograms and breast cancer. The materials being
released today were developed by NCI after they recommended that women in their 40's
and older should get regular screening mammograms.
You will also amplify your strong record on fighting breast cancer including, doubling
funding for breast cancer research, prevention, and treatment, including $30 million in
funding for research into the genetic basis of breast cancer; eliminating the deductible for
the Medicare mammography benefit; and expanding Medicare coverage to all women ages
49 and older making this benefit consistent with recommendations from the National
Cancer Institute (NCI).
The First Lady will launch her annual Medicare mammography campaign. This year
HCFA has focused their campaign on reaching minority Medicare beneficiaries who are
ILL
PARTICIPANTS
4:15 PM - Pre-Brief in Oval Office:
Secretary Shalala, Maria Echaveste, Audrey Tayse Haynes, Ann Lewis, Jordan
Tamagni, Brenda Anders and Barbara Woolley.
FROM:WOMENS
OFFICE
d02-456-7311
PH':5
:00
Radio Address audience of 60 people including (list attached):
Breast cancer survivors and advocates from NBCC, NABCO, Susan G. Komen
Foundation, and other advocacy groups;
Representatives from health care organizations and providers;
Science and technology representatives;
Corporate representatives;
Several persons featured in the new PSA's with the First Lady; and
Personal friends and White House staff
IV.
SEQUENCE OF EVENTS
Briefing.
Mrs. Clinton makes brief welcoming remarks.
You and Mrs. Clinton tape radio address.
Greet guests.
V.
PRESS PLAN
White House photos only. The ABC, CNN, AP, C-SPAN, CBS, NBC, Mutual, UPL,
USA, American Urban Radio Network, and Standard News radio networks will carry the
address live to the collective thousands of stations across the country on Saturday at 10:06
AM ET.
VI.
REMARKS
Prepared by speech writers
VII. ATTACHMENTS
List of participants.
List of National and Corporate Commitments for the National Mammography Campaign.
List of Women Editors' Commitments for the National Mammography Campaign.
Transcripts of three PSA's featuring the First Lady, and the First Lady's remarks in the
PSA's.
Outras walcs FRUITWOMENS OFFICE
PRINE
Elisa Millsap
10/23/97 08:26:15 PM
Record Type: Record
To:
See the distribution list at the bottom of this message
CC:
Subject: MEMBERS ATTENDING RADIO ADDRESS
**I'll send a final list tomorrow morning.
CONFIRMED TO ATTEND:
Sen. Feinstein
Sen. Moseley-Braun
PENDING:
Sen. D'Amato
Sen. Barbara Boxer
Rep. Lowey
Rep. DeLauro
Rep. Slaughter
Rep. Roukema
Rep. Bilirakis
Rep. Pelosi
Message Sent
To:
Rebecca A. Cameron/WHO/EOP
Sondra L. Seba/WHO/EOP
Sarah A. Bianchi/OPD/EOP
Christopher C. Jennings/OPD/EOP
Jennifer M. Palmieri/WHO/EOP
SENT BY:Xenox Telecopier 7020 3-45-17
5018271218-
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MQSA Final Reg.*
Draft Press Release
FDA ISSUES FINAL STANDARDS FOR MAMMOGRAPHY FACILITIES
As part of Breast Cancer Awareness Month, the Food and Drug Administration today
announced final regulations that significantly improve the quality and performance of equipment
and personnel at all mammography facilities in the United States. The rules expand and
strengthen interim regulations in effect since 1994.
"High quality mammograms are essential for early detection of breast cancer," said Health
and Human Services Secretary Donna E. Shalala. "FDA's mammography quality program
assures women that their mammograms will be done by trained medical personnel at properly
equipped facilities and that the resulting images will be of the best possible quality. Our final
regulations will help assure that high quality standards will be a reality at virtually all facilities that
perform mammography in this country."
The final regulations implement the Mammography Quality Standards Act (M
QSA) passed by Congress in 1992 because of concern that not all women were receiving high
quality mammography services and worry that breast cancer was being missed in some women.
MQSA requires that all mammography facilities in the United States meet certain stringent
quality standards, be accredited by an FDA-approved accreditation body, and be inspected
annually.
SENT BY:Xerox Telecopier 7020
5016271213-
S-120245385571#
Over the past three years, the quality of mammography has improved dramatically.
Almost all of the nation's 10,000 mammography facilities have been inspected and accredited.
Prior to 1992, only about 46 percent of facilities were accredited and many facilities were never
inspected.
The regulations require that personnel who perform mammography be adequately trained
and qualified to conduct mammography examinations and interpret results; that mammography
equipment have appropriate design and performance characteristics; and that doctors and patients
be quickly and fully informed of results SO that any follow-up testing or treatment can begin
immediately.
The final rules toughen the standards for personnel, equipment, quality assurance and
quality control, patient notification of results, and accreditation body performance. For example,
physicians who interpret mammograms must now have 60 hours training in mammography,
technologists must keep their skills current by doing an average of 200 mammograms every two
years, and medical physicists who survey mammography equipment and facilities must meet initial
and ongoing training requirements.
The regulations better define equipment capabilities needed for high quality
mammography. They spell out requirements for mammography equipment, including for motion
of the tube-image receptor assembly, image receptor sizes, beam limitation and light fields,
magnification, focal spot selection, compression, technical factor selection and display, automatic
exposure control, x-ray film, lightening, and film masking devices.
The final rules also require more quality control of mobile mammography units and set
new standards for imaging breast implants. They also require that each facility have a consumer
complaint mechanism. In addition, the rules make it clear that original mammograms must be
SENT BY:Xerox Telecopier 7020 ; 3-45-17 1:55AM
30162712184
9+12024565557:*
made available to other medical facilities at the patient's request. This last change is expected to
end the difficulty many women experienced under the interim regulations obtaining previous
original mammograms for comparison with new mammograms, an essential aid to diagnosis.
The new regulations balance cost with the need for mammography to be accessible; they
also balance achieve ability and flexibility
Annual inspections to date show that overall the nation's mammography facilities have a
very good record of complying with standards. The first year's inspections in 1996 showed that
80 percent of the facilities had either no violations or minor ones, and that only two percent had
violations serious enough to warrant a warning letter from the FDA. The second year's
inspections have shown further improvement. So far, less than one percent of facilities have been
found to have serious problem.
The names and locations of accredited facilities are available to calling the Cancer
Information Service at 1-800 4-CANCER (1-800-422-6237). They are also available on the
internet on FDA's home page at www.fda.gov/cdrh/dmqrp.html.
All accredited facilities receive a certificate from the FDA which they must prominently
display stating that they are certified to perform mammography.
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Background on Mammography Bill
S. 537 (Senator Barbara Mikulski) and H.R. 1289 (Representatives Nancy Johnson and
Eleanor Holmes Norton) reauthorize the Mammography Quality Standards Act (MQSA)
of 1992 for another five years, through FY 2002. MQSA established national quality
standards for mammography and requires that all mammography facilities be accredited
by an approved accreditation body, and certified by FDA. The bills also make a
number of technical changes to the Act. Highlights of these changes will:
ensure patients and referring physicians be advised of any mammography facility
deficiencies.
ensure women have the right to obtain the original of their mammogram upon request
for transfer to another medical facility or physician.
clarify that inspection authority may be delegated to local as well as state agencies
(this technical change recognizes that some inspections are now being performed by
county or municipal authorities, such as the city of New York).
For the most part, S. 537 and H.R. 1289 are consistent with the final regulations;
however, there is an unresolved question on requirements for patient notification of
results. The final regulations require that facilities establish a system to ensure the
communication of mammography results to the patient (could be oral, written, through
referring physicians, or a combination of all three). There is some interest in amending
the statute in S. 537 to require facilities to provide a written lay summary of
mammography results directly to the patient.
Status:
Senator Mikulski may try to bring it to the floor either this week or next week. There is
no movement, as of yet, on the House side.
NASA
SPAC 1 CHNOLOGY USED TO DETECT AND TR AT BREAST CANCER
NASA research and technology is revolutionizing American lifestyles in many ways, including improving ways to diagnose and treat breast
cancer. NASA. lesming with industry, academia, and government, is applying aerospace research and technology to battle the leading cause of
death among American women ages 35 to so.
FACTS
IN YOUR DOCTOR'S OFFICE TODAY
Digital Breast Imaging Technology
From NASA's investigations into the mysteries of the universe comes technology to better detect breast cancer. Silicon chips used in the Hubble
Space Telescope were adapted so doctors can easily detect tiny spots in breast tissue and analyze the tissue using a needle rather than subject a
patient to painful surgery. This procedure also eliminates scarring or disfigurement, requires half the time of traditional techniques, reduces exposure
to x-rays, and reduces cost from $3,500 to $850.
TOMORROW'S TECHNOLOGY
Next-Generation Digital Imaging Memmography
Space-based instruments studying the atmosphere will soon be In the medical examination room. NASA is developing a mammogram to produce
40 Image of the entire breast and provide è better image - two times better than currently evailable - to identify tumors. Current technology
does not allow doctors to view the entire breast. This approach also is significant because it will accommodate different tissue density, which is
particularly important for younger women who have more dense tissue.
Telemammography
NASA expertise in transmitting high-resolution digitized photographs has led to improvements in global satellite networks. Soon, women in I
areas will have d link to medical experts dcross the country using these networks. This new technology will be more cost-effective and Faster than
traditional transmission d dsis through telephone lines, which can take hours to transmit one image. High-resclution manmography also will help
doctors detect breast cancer tumors earlier.
Thesue Growth in the NASA Biorgacior
NASA uses the microgravity of space to grow human tissue for research and transplantation and to gain valuable knowledge Important to
the treatment of breast and overlan cancer. The NASA designed Bioreactor Is . unique tissue culture chamber that grows cells in three
dimensions. These tissues, similar to tissues found in the body, will help scientists understand cancer growth and how the human immune
system responds.
Advanced Ultresound Technology
Mars Pathfinder technology developed to enhance pictures is being modified to make three-dimensional models of breast tissue. Combining
ultrasound with advanced computing, the imaging device discerns cancerous from healthy tissue by comparing changes in shape and and-
lyzing the ultrasound signal. This enables doctors to differentiate the tissue more accurately without using painful invasive procedures.
Smart Robot Brain Surgeon Probe Adopted for Cancer Detection
Technology being developed for surgery on astronauts in space is being adapted to help physicians operate on delicate parts of the human body
and minimize harm to healthy tissue. The robot maps the physical characteristics of the brain, allowing the surgeon to make precise movements and
reduce potential damage to nearby healthy tissue. Researchers plan to teach the robot to feel and see tumors in other parts of the body, such as
the breast. One component includes a small probe that may allow real-time measurement and analysis of a breast cancer tumor to determine its
severity and appropriate treatment.
HASA'S SPACE TECHNOLOGY PROMISES A HEALTHIER TOMORROW FOR WOMEN
Women's Outresch Initiative Office of Public Affairs National Aeronautics and Space Administration October 1997
NASAFacts
NASA
National Aeronautics and
Space Administration
Washington, D.C. 20546
(202) 358-1600
Terri Hudkins
For Release
Headquarters, Washington, DC
October 23, 1997
(Phone: 202/358-1977)
SPACE TECHNOLOGY USED TO DETECT AND TREAT BREAST CANCER
NASA today announced how its research and technology is revolutionizing American
lifestyles in many ways, including the diagnosis and treatment of breast cancer. Teaming
with industry, academia and government, NASA joins the front lines in the battle against
the disease and continues its October campaign for Breast Cancer Awareness Month.
"As a husband, father of two daughters, and a grandfather, few subjects are as
important to me as women's health," sald NASA Administrator Daniel S. Goldin. "That is
why I am so proud of how NASA technologies, originally developed for our space and
aeronautics programs, improve health care for women, men and children around the
world."
Breast cancer is the leading cause of death of women ages 35 to 50 in the United
States. More than half a million women undergo breast biopsies In the U.S. each year.
"The statistics of breast cancer are startling. Thanks to NASA technology, doctors are
using a more sensitive and efficient diagnostic tool and a less painful, less traumatic
procedure," said Administrator Goldin. "Looking to the future, NASA will continue to
search for more ways to use technology for breast cancer diagnosis and treatment."
In addition to exploring space and developing aeronautics, NASA is charged with
applying its technology to Improve the quality of life.
"Our visionary researchers and entrepreneurs have made giant leaps in applying
technology to medical uses. Who would have dreamed that we could map breast tissue by
using the same technology for mapping distant stars?" he concluded.
Several NASA biomedical experiments have resulted In successful new technology
programs between NASA, the National Institutes of Health, the National Cancer Institute
and the U.S. Department of Health and Human Services Office on Women's Health.
-more-
20'd
NASA CODE PSN
2023584388
10-23-1997 10:12
-2-
IN YOUR DOCTOR'S OFFICE TODAY
Digital Breast Imaging Technology
From research Into the mysterles of the universe comes a technology to better detect
breast cancer. Sillcon chips in the Hubble Space Telescope that convert a distant star's
light directly into digital Images have been adapted so doctors can easily detect tiny spots
in breast tissue. Locating the exact spot allows doctors to analyze the tissue using a
needle rather than by traditional surgery. This procedure is less painful and less traumatic
for the patient and eliminates scarring or disfigurement. The new procedure requires half
the time of traditional techniques and reduces costs from $3500 to $850.
The new technology Images breast tissue more clearly and efficiently than conventional
x-rays. Both the Hubble Telescope and mammograms require similar technology: high
resolution to see fine details, wide dynamic range to capture in a single image structures
spanning many levels of brightness, and low light sensitivity to shorten exposure and
reduce x-ray dosage. The new highly sensitive Hubble-based technology is Improving
breast cancer detection. Scientists working with Hubble at NASA's Goddard Space Flight
Center, Greenbelt, MD, continue to refine and develop this technology.
TOMORROW'S TECHNOLOGY
Next Generation Digital Imaging Mammography
Space-based instruments used to study the atmosphere may soon have a place in the
medical examination room. This new approach is significant because it can accommodate
different tissue density. This is particularly Important for younger women, who have more
dense tissue than older women. This new technology application is possible because
atmospheric studies and mammography both require compact, reliable, low-power
sensors and digital computers.
NASA Is working with the National Institutes of Health on a prototype that would create
an Image of the entire breast with superior resolution.
The computer scans each part of every mammogram image and reports any suspicious
areas. The electronic Images can then be transmitted to other experts If more opinions are
needed. Using the best mammogram technique currently available, tumors as small as
0.2 mm, about the thickness of a piece of thread, have been detected. The goal of digital
mammography is to identify clearly tumors as small as 0.1 mm. The approach of NASA's
Langley Research Center, Hampton, VA, will be faster, safer, easler to use and save
countless lives.
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Advanced Ultrasound Technology
Technology developed to improve the quality of plctures from Mars Pathfinder is being
modified to make three-dimensional models of breast tissue. The NASA effort, led by
scientists at NASA's Ames Research Center's Computational Sciences Division, Moffett
Field, CA, combines ultrasound with advanced computing, automated learning, and high-
resolution imaging techniques developed for space missions. Using the three-
dimensional model, physicians will be able to differentlate between cancerous and healthy
tissue without painful invasive procedures. The experimental system also will discern
differences in tissue by comparing changes in shape and by analyzing the ultrasound
signal. The system will potentially Improve cancer treatment by focusing ultrasound
signals on cancerous tissue without destroying healthy tissue.
Smart Robot Probe for Cancer Detection
NASA technology being developed to perform surgery on astronauts in space is being
adapted to help physicians operate on delicate parts of the human body, including the
brain and the breast. Led by the NeuroEngineering Group at NASA's Ames Research
Center, scientists have developed a robot that can map physical characteristics of the
brain, allowing the surgeon to make precise movements during surgery. The technology is
being modified further to have the robot feel tumors in other parts of the body to
severity and appropriate treatment.
The density of cancerous tissue is different from healthy tissue. While a surgeon can,
through experience, learn to feel the difference, the experimental robot can use a smaller,
less invasive probe, and it can make more delicate and precise movements than a human,
thus reducing damage to healthy tiesue and arteries.
Telemammography
The most effective method for improving breast cancer survival is early detection. For
women living in remote areas, access to mammography experts may be hundreds of miles
away. Currently, the traditional transmission of data through telephone lines is slow and
costly; il can take hours to transmit one image. NASA technology will help provide quality
medical diagnosis and information services to remote areas in a faster, more cost-effective
manner.
Telemammography, the electronic transmission of digitized mammograms, can connect
patients in rural locations with medical experts across the country.
NASA's Lewis Research Center, Cleveland, OH, working with breast cancer research
hospitals, Including the Cleveland Clinic and the University of Virginia, is performing
critical research to allow new satellite networks to support telemammography.
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Tissue Growth In the NASA Bloreactor
NASA's Johnson Space Center, Houston, TX, is leading a project using the microgravity of
space to assemble and grow human tissue for research and transplantation.
The bioreactor is a special tissue culture chamber designed by NASA to grow cells in
three dimensions. One of the first experiments in this unique environment will allow
cancer tissue to be assembled and grown from individual cells. The three-dimensional
tissues are crucial to understanding cancer and how the human Immune system responds.
The bloreactor permits scientists to grow cells similar to tissues found in the human body.
By testing three-dimensional tissues for sensitivity to chemotherapy and hormonal therapy,
researchers gain valuable knowledge important to the treatment of breast and ovarian
cancer.
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EDITOR'S NOTE:
Photo and video resources and interview opportunities with contacts nationwide_are
provided below.
Stereotactic Blopsy using HST technology
Photos: Sterotactic Blopsy Machine
94-HC-168 color; 94-H-180 b&w
Charged Coupling Device
94-HC-169 color; 94-H-183 b&w
Hubble Photos of Star Fields Using STIS
97-HC-314 color; 97-H-314 b&w
Hubble Space Telescope in space
94-HC-10 color: 94-H-13 b&w
Eagle Nebula Image using HST
95-HC-631 color; 95-H-631 b&w
Video resources:
"War Against Breast Cancer" October 1995
"Stereotactic" Testimonials, Aug. 1996 TRT 3:30
Interviews:
Space Telescope Science Institute:
Mr. Ray Villard
Director of Public Affairs
Baltimore, MD
410/338-4514
SO
NASA's Goddard Space Flight Center:
Ms. Tammy Jones
Public Affairs Officer
Greenbelt, MD
301/286-5566
Clinicians Using Technology:
David Dershaw, MD
Director, Breast Imaging
Memorial Sloan-Kettering Cancer Center
New York, NY
212/639-7295
Dr. Wendi Berg
Director, Breast Imaging
University of Maryland Medical Systems
Baltimore, MD
410/328-1289
For interviews with patients:
Ms. Chris Westerman, Director of Communications
Memorial Sloan-Kettering Cancer Center
New York, NY
212/639-3627
W. Phil Evans, MD, FACR
Medical Director, Susan Coleman Breast Center
Baylor University
Dallas, TX
214/820-4775
Steve H. Parker, MD
Medical Director, Sally Jobe Breast Center
Denver, CO
303/741-1501
Lawrence W. Bassett, MD
Irls Cantor Professor of Breast Imaging
University of California Los Angeles School of Medicine
Los Angeles, CA
310/206-9608
Valerie P. Jackson, MD
John A. Campbell Professor of Radiology
Indiana University School of Medicine
Indianapolla, IN
317/656-3919
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Developer of CCDs for Hubble:
AI Jenkins
Scientific Imaging Technologies, Inc. (SITe)
Beaverton, OR
503/644-0688
Stereotactic Blopsy Equipment Manufacturer:
Ms. Anne Smith
Lorad Division, Trex Medical Corporation
Danbury, CT
203/790-1188
Digital Mammography
Photos:
SAGE instruments
Video:
SAGE III videofile 10/97 with 1 Interview
Internet:
http://oea.larc.nasa.gov/PAlS/Mammography.html
Interviews:
Mike Finneran
Office of Public Affairs
NASA Langley Research Center
Hampton, VA
757/864-6121
Advanced Ultrasound Technology
Internet:
http://c-www.arc.nasa.gov/ic/projecte/bayes-group/superres/
Interviews:
Peter Cheeseman, PhD
Data Understanding Group
Computational Sciences Division
NASA Ames Research Center
Moffett Fleld, CA 94035
650/604-4946
Smart Robot Probe for Cancer Detection
Photos:
Dr. Robert Mah and smart robot probe
AC-97-0063-7 & AC-97-0063-8
Drs. Robert Mah and Stefanie W. Jeffrey, discussing
development of smart probe for breast cancer
AC97-0350-2
Video:
robot probe in brain surgery AAV1563 5/29/96
Internet:
http://cwww.arc.nasa.gov/ic/projects/neuro/SMART_SYSTEM
Interviews:
Robert W. Mah, PhD
NeuroEngineering Group
NASA Ames Research Center
Moffett Fleld, CA 94036
650/604-6044
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Stefanle S. Jeffrey, MD
Chief of Breast Surgery
Assistant Professor
Div. of Surgical Oncology
Dept. of Surgery
Stanford University
School of Medicine
Palo Alto, CA 94305
650/723-4617
Russell J. Andrews, MD
Department of Neurosurgery
SUNY Health Science Center 650/723-4617
750 East Adams St.
Syracuse, NY 13210
315/464-4470
NASA Bioreactor and Cancer Cell Research
Photos:
Astronaut working with Bioreactor
94-HC-288
Mary Ellen Weber works with Bioreactor
95-HC-497 color; 95-H-497 b&w
Interviews:
Dr. Neal Pellls
NASA Researcher
NASA Johnson Space Center
Houston, TX
281/483-2357
Jeanne L. Becker, PhD
Principal Investigator, Ground-Based Bioreactor Studies
Associate Professor
University of South Florida
Tampa, FL
813/254-7774
Elliot M. Levine, PhD
Professor, Wistar Institute
Philadelphia, PA
215/898-3884
Telemammography
Photos:
ACTS Satellite
93-HC-527 color; 93-H-575 b&w
Video:
Cleveland Clinic with 1 Interview 10/97
Interviews:
Sally V. Harrington
Public Affairs Specialist
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NASA Lewis Research Center
Cleveland, OH
216/433-2037
Samuel J. Dwyer III, MD
Department of Radiology
University of Virginia
Charlottesville, VA
804/924-5976
Kimberly A. Powell, PhD
Assistant Staff Scientist
The Cleveland Clinic Foundation
Cleveland, OH
216/445-9364
William A. Chilcote, MD
Staff Radiologist
The Cleveland Clinic Foundation
Cleveland, OH
216/444-6413
Linda Dukes-Campbell
NASA Lewis Research Center
Public Affairs Office
Cleveland, OH
216/433-8920
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October 25, 1997
Contact: FDA Press Office
(301) 443-3285
Mammography Quality Standards Act
Overview: In October 1997, years of effort culminated in the publication of the final rules of the Mammography
Quality Standards Act (MQSA). The final regulations toughen the requirements that first became effective in
1994. They assure that mammograms are done only by trained medical personnel at properly equipped
facilities. that the resulting images are of the best possible quality, and that facilities employ skilled physicians
10 interpret the results.
Congress-passed the MOSA in 199210 ensure that all mammography done at the approximately 10,000
facilities in this country is safe and reliable. The Food and Drug Administration (FDA), the agency responsible
for implementing and enforcing the MQSA, set forth initial standards that mammography professionals and
facilities had to meet by October 1, 1994. The publication of the final rules this year builds on and-strengthens
those standards Standards must be met within 18 months after the publication of the final rules and all
facilities are inspected annually to ensure compliance.
The
Breast Cancer's Tragic Toll
Breast cancer is the second leading cause of cancer deaths in American women, following lung cancer.
Since the early 1970s, the incidence of breast cancer has increased about 1 percent a year
An estimated 44,000 women will die from breast cancer in 1997, and an estimated 180,000 new cases of the
disease will be diagnosed.
Nearly half a million women will die of breast cancer in the 1990s. and more than one-and-a-half million
new cases will have been diagnosed in this decade.
Mammography: Why High Quality Is Important
Mammography, a special x-ray examination of the breast, is currently the most effective method for
detecting breast cancer early.
High-quality mammography can find 85 to 90 percent of breast tumors in women over 50
Widespread screening of women over 50, followed by prompt treatment when needed, can reduce cancer
deaths by as much as 30 percent.
If breast cancer is detected early, the cancer is less likely to have spread, giving a woman the best chance for
survival.
Setting a New Standard
Mammography can fail to do its job because of poor technique in taking, processing or reading the films;
inadequate record keeping and reporting of results; and lack of effective quality assurance controls Under the
MQSA, all mammography facilities are required to display their FDA certificate. To be certified, a facility must
meet quality standards for x-ray images and equipment, personnel standards, and record keeping and reporting
requirements.
Evidence of problem
inding a Certified Facility
Information on regional certified facilities is available from the toll-free number of the NCI's Cancer
Information Service at 1-800-4 CANCER
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Contact: HHS Press Office
(202) 690-6343
NCI Press Office (301) 496-6641
FDA Press Office (301) 827-6242
BREAST CANCER: NEW EFFORTS UNDERWAY
Overview: Breast cancer is the most commonly diagnosed cancer and the second
leading cause of cancer deaths among American women. There is no proven way to
prevent breast cancer. so early detection through mammography and clinical breast
exams is essential.
For women age 50-69, having regular mammogi ams can reduce the chance of death
from breast cancer by one-third or more. Despite these numbers, 33 percent of women
ages 50=64, and 45 percent of women age 65 and older reported not receiving a
mammogram during the past two years.
The Clinton Administration has responded to the significant threat posed by breast
cancer with increased efforts in research, prevention and treatment. HHS Secretary
Donna E. Shalala convened a conference in December 1993 10 establish a National
Action Plan on Breast Cancer The national plan. which is being carried our today by
the public, private and volunteer sectors, is a kev clèment of the Administration's
commitment to fighting breast cancer.
At the same time; spending on breast cancer resear at HHS' National Institutes.of
Health has increased from $229 million in FY 1993 to $401 million in FY 1997, and a
proposed budget of $408 million in FY 1998.
In 1995, First Lady Hillary Rodham Clinton launched a campaign urging older women
to obtain mammograms, and, in particular. to promote use of Medicare coverage för
mammography. Both the President and the First Lady have appeared in TV public
service announcements encouraging older women to get mainmography screening
And this year. President Clinton proposed, and Congress adopted, the expansion of
Medicare coverage which will help pay for annual mammograms for all Medicare
beneficiaries age 40 and over. This new benefit will be available starting
January 1, 1998.
Background: More Women Can Survive Breast Cancer
The lifetime risk of developing breast cancer today is one in every eight women, up from
one in every 13 women just two decades ago. Although death rates from breast cancer have
been declining in recent years. breast cancer accounts for 31 percent of all cancers among
women.
2001
Approximately 180,000 new cases of breast cancer will be diagnosed in 1997, and about
44,000 women are expected to die from breast cancer. Epidemiologic studies estimate that
breast cancer will be diagnosed in 1.5 million American women in this decade and that
breast cancer will claim nearly half a million lives:
Death rates from the disease are highest among older, black, and low-income women.
With proper screening and treatment, however, the chances of surviving, breast cancer are
improving Breast cancer-mortality trends among both black and v hite women have
improved markedly in the United States since the 1980s. Between 1982 and 1987, breast
cancer incidence for women increased about 4 percent per year, but recently has leveled off.
The death rate for women with breast cancer declined 6.3 percent between 1991 and 1995.
The greatest reductions in death rates were among younger women (9.3 percent) and white
women (6.6 percent), with more modest reductions among African Americans (1.6 percent)
and women age 65 and older (2.8 percent).
During the most recent 5-year period, death rates among white women declined for
all decades of age from 30 to 79 years. Among black women, rates were down for
all decades of age from 30 to 69 years. Among both groups, the greatest
improvements in mortality were seen in the younger age groups. For women aged 30
to 39 years, rates dropped about 13 percent among whites and 5 percent among
blacks. For women aged 40 to 49 years, rates dropped 9 percent among whites and 2
percent among blacks.
HHS Spending On Breast Cancer
HHS discretionary funding for breast cancer research, prevention and treatment has increased from
approximately $274 million in FY 1993 to an estimated $513 million in FY 1997. As the Centers
for Disease Control and Prevention (CDC) have worked to increase access for all women to
mammography screening and follow up services, the resources devoted to breast cancer services
have increased from an estimated $42 million in FY 1993, to $81 million in FY 1997. Cancer
research is vital to our understanding of how to prevent, detect and treat breast cancer. The Clinton
Administration has invested in breast cancer research at the National Institutes of Health by
increasing funding from $229 million in FY 1993, to $401 million in FY 1997, and a President's
budget request of $408 million in FY 1998. HHS also helps provide treatment for breast cancer
through the Medicare and Medicaid programs and through the Indian Health Service.
HHS Action To Combat Breast Cancer
Under President Clinton, a wide array of activities are underway and new initiatives have been
launched:
New Mammography Benefit
President Clinton proposed, and Congress adopted, the expansion of Medicare coverage which will
help pay for annual mammograms for all Medicare beneficiaries age 40 and over. This new benefit
will be available starting January 1, 1998.
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Mammography Quality Standards
Congress passed the Mammography Quality Standards Act (MQSA) in 1992 to ensure that all
women have access to high quality mammography services. Under the final rules of the
Mammography Quality Standards Act (MQSA), published in October 1997, the FDA sets high
standards for mammography facilities and certifies those which meet the standards. The roughly
10,000 mammography facilities nationwide accredited by the FDA must meet quality standards for
equipment and personnel, and are inspected annually.
These regulations spell out the details for requiring facilities to hire capable technologists, use
quality dedicated equipment that produces clear images, and employ skilled interpreting physicians
to interpret the results both accurately and efficiently. The rules also require that doctors and
patients be fully and quickly informed of results so that any follow-up testing or treatment can begin
immediately. The names and locations of FDA certified mammography facilities are available by
calling the Cancer Information Service at 1-800-4-CANCER. In addition, the FDA has included a
list of all FDA certified mammography facilities in the United States on its internet home page. The
address is http://www.fda.gov/cdrh/faclist.html.
National Action Plan on Breast Cancer
HHS' Office on Women's Health is coordinating the National Action Plan on Breast Cancer. This
first-ever national plan was developed in 1993 under Secretary Shalala's leadership. The Plan has
awarded over $9 million in grants for 99 innovative research and outreach projects, with a special
emphasis on the development of public-private partnerships targeted in the six priority areas:
The Information Action Council Working Group is working to improve access to
information about breast cancer for consumers, scientists, and practitioners via the Internet
and other information technologies.
The Etiology Working Group is focusing on efforts to expand the scope and breadth of
biomedical, epidemiological and behavioral research on breast cancer. The group has
identified four priority areas: chemicals and hormones, viruses, radiation and
electromagnetic fields, and lifestyle factors.
The National Biological Resources Banks Working Group (NAPBC) has focused on the
development of a national mechanism and standard for obtaining and storing tissue for
multiple areas of breast cancer research. The NAPBC has awarded funds to establish a
national biological resources bank and is now conducting a survey of tissue banks
throughout the country to identify and determine the accessibility of all available biological
resources.
The Working Group 10 Ensure Consumer Involvement has defined several specific activities
to help ensure consumer involvement at all levels in the development of national research,
education, and service delivery programs related to breast cancer.
The Clinical Trial Accessibility Working Group has identified a series of initiatives to
address four types of barriers to participation in clinical trials, including barriers associated
with the informed consent process, patient and physician misperceptions about clinical trials,
lack of information about the availability of trials, and cost.
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The Working Group on Heredity Susceptibility is evaluating the ethical, legal and policy
issues of individuals carrying breast cancer susceptibility genes.
On October 27, 1996, President Clinton launched the National Action Plan on Breast Cancer
(NAPBC) Internet web site. The web site, developed by a public/private partnership and
coordinated by the Department of Health and Human Services Office on Women's Health is
designed to serve as a gateway to information on breast cancer research, treatment, and prevention
The web site provides answers on frequently asked questions about breast cancer, as well as
information on the NAPBC, breast cancer clinical trials and research, breast cancer organizations
and advocacy groups, educational conferences, publications, and government and private resources
The web site address is: http://www. napbc.org.
Discovery of BRCAI and BRCA2 Genes for Breast Cancer
Breast cancer research has been expanded at the National Institutes of Health. Promising news
came late in 1994 when a team of investigators at the University of Utah, Myriad Genetics, and the
National Institute of Environmental Health Sciences (NIEHS) identified a breast cancer
susceptibility gene (BRCA1) that may account for 5-10 percent of the breast cancers diagnosed each
year. The discovery of a second, entirely different breast cancer susceptibility gene, BRCA2, has
helped us understand even more about the genetics of breast cancer. Most recently researchers
discovered a particular variant of the BRCA1 susceptibility gene in Jewish women of eastern
European descent (Ashkenazi Jews). While only 5-10 percent of all breast cancers are the result of
an inherited anomaly, these findings hold promise for the development of new prevention and
treatment strategies.
Other breast cancer research includes psychosocial research, which looks at how to enhance the
quality of life in women with breast cancer, and the Breast Cancer Prevention Trial which is
studying ways in which to prevent breast cancer.
On October 27, 1996, President Clinton announced $30 million in new funding for research into the
genetic basis of breast cancer through a collaborative initiative between the Department of Defense
and the National Institutes of Health.
Privacy of Medical Records and Breast Cancer
President Clinton is urging Congress to enact legislation to protect the privacy of personal medical
records. For example, the Administration's recommendations would establish a basic national
standard of protection for women who are carrying a specific genetic mutation such as those in
breast cancer genes BRCA1 and BRCA2. There would be clear guidance and significant incentives
for the appropriate use of personal information by those in the health care field, and real penalties
for misuse.
Genetic Discrimination legislation
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National Breast and Cervical Cancer Early Detection Program
The CDC's National Breast and Cervical Cancer Early Detection Program offers free or low-cost
mammography screening to uninsured, low-income, elderly, minority, and Native American women
nationwide. The resources devoted to breast cancer screening services have increased from an
estimated $42 million in FY 1993, to $81 million in FY 1997. The program, which has been
operating in an increasing number of states over the past six years, has provided screening tests to
almost one million medically underserved women. In October, 1996, the program went nationwide,
with funding for all 50 states.
Breast Cancer Among the Elderly
The Agency for Health Care Policy and Research (AHCPR) is currently funding a five-year Patient
Outcomes Research Team study on the care, costs, and outcomes of early stage breast cancer. The
study will examine three alternative treatments for early stage breast cancer in the elderly: modified
radical mastectomy, breast-conserving surgery with radiotherapy, and breast-conserving surgery
without radiotherapy. The project will look at quality and cost-effectiveness in these projects and
will develop clear recommendations for treating early stage breast cancer in the elderly.
New Frontiers In Breast Cancer Early Detection
The Department of Health and Human Services has been working with the Department of Defense,
the CIA, NASA, and other public and private entities to explore ways in which imaging
technologies from other fields may be applied to the early detection of breast cancer. In particular,
the computer technologies that have been used to improve spy satellites may help improve breast
cancer detection as well. In October, 1996, HHS awarded $1.98 million to the University of
Pennsylvania to conduct a series of clinical trials of imaging technology from the intelligence
community originally used for missile guidance and target recognition -- to improve the early
detection of breast cancer.
Centers of Excellence
On October 1, 1996, the Department of Health and Human Services established six National
Centers of Excellence in Women's Health to serve as national models for improving the health care
of American women. The new Centers of Excellence program, with facilities located at academic
institutions in different areas of the country, will integrate health care services, research programs,
public education and health care professional training.
Mammography Clinical Practice Guidelines
Recognizing the importance of the quality of screening mammograms in the early detection of
breast cancer the AHCPR October 1994, veloped a Clinical Practice Guideline Quality
Determinants of Mammography--with separate versions for mammography providers, health care
professionals, and consumers. The guidelines provide information on the roles and responsibilities
of each health care professional involved in mammography services, as well as information and
recommendations for women.
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Mammography for Women with Addictive and Mental Disorders
Women who are in need or who receive substance abuse or mental health services often lack
appropriate primary health care, including breast cancer education, detection, and treatment
Women-focused substance abuse and mental health programs funded by the Substance Abuse and
Mental Health Services Administration (SAMHSA) are designed to be comprehensive, delivering
primary health care services to women who often are medically underserved These services
include education on breast self-examination and mammography services, and counseling on risks
for breast cancer.
Environmental Factors and Breast Cancer
HHS' Office on Women's Health has established a Federal Interagency Coordinating Committee on
the Environment and Women's Health that focuses on how home, work, atmospheric pollutants,
exogenous hormones, drugs, and other environmental factors may contribute to the risk of breast
cancer and other disorders.
Office of Cancer Survivorship
On October 27, 1996, President Clinton unveiled the new Office of Cancer Survivorship at the
National Cancer Institute. Recent success of cancer prevention, early detection, and treatment
efforts has created a new need: research into the physical, psychological, and economic well-being
of the growing number of cancer survivors. The Office of Cancer Survivorship will support
research covering the range of issues facing survivors of cancer, including long term medical and
psychological effects; factors that predispose survivors to second malignancies; reproductive
problems following cancer treatment; and their unique insurance and employment issues.
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Limitations of Mammography
While mammography is the best screening tool available now, early detection does not
necessarily mean lives will be saved. Mammography may not help a woman with a small but fast
growing tumor that has already spread at the time of detection. And about 50 percent of women whose
breast cancer is detected by mammography would not have died from the cancer even if they had waited
until a lump could be felt because the tumors are slow-growing and easy to treat.
Breasts of younger women contain many glands and ligaments that appear dense on a
mammogram, SO it is sometimes difficult to spot tumors in their breasts. About 25 percent of breast
tumors are missed in women in their 40s compared to 10 percent for women in their 50s.
Also, between 5 percent and 10 percent of mammograms are abnormal. Of those in younger women that
are followed up with additional tests (another mammogram, fine needle aspiration, ultrasound, or
biopsy) most will not be cancer. Over the past 30 years, mammography has been able to detect a higher
proportion of small tissue abnormalities called ductal carcinoma in situ (DCIS), abnormal cells confined
to the milk ducts of the breast. Some believe these tumors are not life threatening, while others think
they are. Because there is so little data to support either view, the abnormalities are commonly removed
surgically.
HHS is supporting a variety of research projects aimed at improving breast cancer detection.
HHS PROGRAMS SUPPORTING MAMMOGRAPHY
Mammography Quality Standards. Under the final rules of the Mammography Quality Standards Act
(MQSA), published October 1997, the FDA sets high standards for mammography facilities and certifies
those which meet the standards. The roughly 10,000 mammography facilities nationwide certified by
the FDA must meet quality standards for both equipment and personnel, and are inspected annually.
MQSA regulations require facilities to hire capable technologists, use quality dedicated equipment that
produces clear images, and employ skilled interpreting physicians to interpret the results both accurately
and efficiently. The rules also require that doctors and patients be fully and quickly informed of results
so that any follow-up testing or treatment can begin immediately: Resources devoted to the MQSA
total $26.4 million for FY 1997, and the proposed budget for FY 1998 is $27 million.
The names and locations of FDA certified mammography facilities are available by calling the Cancer
Information Service at 1-800-4-CANCER. In addition, the FDA has included a list of all FDA certified
mammography facilities in the United States on its internet home page. The address is
http://www.fda.gov/cdrn/faclist.html
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Research To evelop Better Screening. New imaging technologies under development for breast
cancer screening include magnetic resonance imaging, breast ultrasound, and breast-specific positron
emission ography. In addition to imaging technologies, NCI-supported scientists are exploring
methods to detect breast cancer using simple tests of the blood, urine, or nipple aspirates, and to detect
genetic alterations that place women at increased risk for breast cancer.
In addition, HHS is working with the Department of Defense, the CIA, NASA, and other public and
private entities 10 explore ways in which imaging technologies from other fields may be applied to the
early letection of breast cancer. In particular, the computer technologies that have been used to improve
spy satellites may help improve breast cancer detection as well. In October, 1996, HHS awarded $1.98
million to the University of Pennsylvania conduct a multi-site clinical trial of imaging techne logy
from the intelligence community -- originally used for missile guidance and target recognition -- to
improve the early detection of breast cancer.
Mammography Clinical Practice Guidelines. Recognizing the importance of the quality of screening
mammograms in the early detection of breast cancer, HHS' Agency for Health Care Policy and Research
developed a Clinical Practice Guideline - Quality Determinants of Mammography - with separate
versions for mammography providers, health care professionals, and consumers. The guideline provides
information on the roles and responsibilities of each health care professional involved in mammography
services, as well as information and recommendations for women.
Medicare and Medicaid Coverage of Mammography Since 1991, Medicare has covered
mammography screening for the early detection of breast cancer. For women age 40-49, Medicare
currently covers one screening mammogram every two years, except for women with a high risk (for
example, a woman with a mother, sister or daughter who has had breast cancer), in which case annual
mammograms are covered. For women age 50-64, annual screening mammograms are covered; and for
women 65 and Ider, Medicare covers one screening mammogram every two years.
President Clinton proposed, and Congress adopted, the expansion of Medicare coverage which will help
pay for annual mammograms for all Medicare beneficiaries age 40 and over. This new benefit will be
available starting January 1, 1998.
Under Medicaid, diagnostic mammograms are a mandated service and states must cover them.
Screening mammograms, wever, are provided by states as an optional service, with most states
covering screening mammograms in fee-for-service Medicaid. In addition, virtually all Medicaid
managed care plans offer preventive services, including mammography, to their enrollees.
The Health Care Financing Administration has urged states to provide annual mammography screening
to Medicaid beneficiaries at age 40; HCFA will continue to provide federal matching payments for
annual mammography screening services.
5
WED FAX 2026905673
National Breast and Cervical Cancer Early Detection Program. The CDC's National Breast and
Cervical Cancer Early Detection Program offers free or low-cost mammography screening to uninsured,
low-income, elderly, minority, and Native American women nationwide. The resources devoted to
breast cancer screening services are estimated to have increased from $42 million in FY 1993, to $81
million in FY 1997. The program, which has been operating in an increasing number of states over the
past six years, has provided screening tests to almost one million medically underserved women. In
October, 1996, the program went nationwide, with funding for all 50 states.
Privacy of Mammography Records. President Clinton is urging Congress to enact legislation to
protect the privacy of personal medical records. These recommendations would establish a basic
national standard of protection for mammography records, and women whose medical records reflectiva
specific genetic mutation such as those in breast cancer genes BRCA1 or BRCA2. There would be clear
guidance, and significant incentives for the fair treatment of personal information by those in the health
care field, and real penalties for misuse.
Mammography for Women with Addictive and Mental Health Disorders. Women who are in need
or who receive substance abuse or mental health services often lack appropriate primary health care,
including breast cancer education, detection and treatment. Women-focused substance abuse and mental
health programs funded by the Substance Abuse and Mental Health Services Administration (SAMHSA)
are designed to be comprehensive, delivering primary health care services to women who often are
medically underserved. These services include education on breast self-examination and mammography
services, and counseling on risks for breast cancer.
###
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HUMAN SERVICES USA
DEPARTMENT OF HEALTH & HUMAN SERVICES
2
HEALTH
Laurie Boeder
OF
Deputy Assistant Secretary for Public Affairs
Phone: (202)690-7850
Fax: (202)690-5673
To:
Sarah Bianch,
HIVERVE
NA
NA
Issue
Fax: 456-5557
Phone: 456-5585
Date: 10/1/97
Total number of pages sent: 21
Comments:
Re: HCFA Mammography materials
-
Fact Shut
- "Horizons" Summary
Please let me know if you have
any questions. thanks.
- michile
200 Independence Avenue, S.W., Bldg. HHH, Room 647-D, Washington, D.C. 20201
HCFA & Breast Cancer/Mammography
I.
New Annual Screening Mammography Benefit Under Medicare
New law signed by the President on August 5, 1997, as part of the Balanced Budget Act
of 1997 provides Medicare coverage for annual screening mammograms for all Medicare
eligible women age 40 and over, and waives the Part B deductible for screening
mammography, effective for services provided on or after January 1, 1998.
Explanation of prior law compared to new law:
o
Frequency of coverage for mammography
Prior law provided coverage of annual screening mammograms for women age 50-
64, and those at high risk age 40-49. However, screening mammograms for
women over 64, and for women at normal risk age 40-49, were covered only
biennially. The new law expands coverage to pay for annual screening
mammograms for all female Medicare beneficiaries age 40 and over, for services
provided on or after 1/1/98. This change removes an anomaly in the prior law that
provided more frequent mammography for women age 50-64 than for those over
64, even though the risk of breast cancer increases with age. It also makes
coverage consistent with the frequency recommendations of most major breast
cancer authorities.
Cost-sharing for mammography services
Prior law required beneficiaries to pay the Part B deductible (to the extent not
already met) and 20% coinsurance for both screening and diagnostic
mammograms. The new law waives the deductible for screening mammograms for
services provided on or after 1/1/98. Beneficiaries must still pay 20% coinsurance
for screening mammography, and must pay both the unmet deductible and 20%
coinsurance for diagnostic mammography.
II.
Programs Under HCFA's National Mammography Campaign
Mammography HORIZONS Project
As part of the HCFA HORIZONS Program: Special Partnerships for Special Populations,
a mammography project is being conducted to develop local partnerships for Hispanic
American and African American communities in six major cities - Philadelphia, Atlanta,
Cleveland, Chicago, San Antonio, and Los Angeles. Partners will work together to
conduct locally planned interventions to increase the rates of mammography screening for
Medicare beneficiaries in these communities. We have completed the market research
phase, examining the knowledge, attitudes and beliefs of beneficiaries and health care
providers to better understand the barriers to mammography utilization in those cities.
One-day meetings are being held in each of the cities, including all the key stakeholders, to
begin planning appropriate interventions which will be conducted by the PROs in
collaboration with the partner organizations. The mammography HORIZONS project is a
three year commitment by HCFA to increase the use of Medicare mammography
screening services.
Preventive Screening Services Project
- A-collaborative project with the Centers for Disease Control and Prevention and
Maryland's Department of Health and Mental Hygiene is being conducted to evaluate the
effectiveness of physician referral, prompted by an office reminder system for
mammography and papsmears utilization (as reflected in Medicare billing data) for
Medicare African-American beneficiaries age 65 and older.
Mammography Campaign Print Materials
HCFA tested mammography messages and visual designs on female Medicare
beneficiaries age 65 and over in order to provide these women with relevant,
understandable printed information about the importance of regular mammograms and
Medicare coverage available for mammograms. Based on the results of this testing we
designed postcards, posters, bookmarks and stickers. The messages and graphic design
on the materials are simple and straight forward and were accepted amongst the variety of
ethnic and racial groups tested. The materials are in English and Spanish and will be
distributed to Medicare beneficiaries through HCFA's contractors (Peer Review
Organizations, Carriers, ICA Grantees, and HMOs) and various partners (health
departments, breast cancer groups, beneficiary auvocacy groups, etc.).
Mammography Data Books
HCFA has printed mammography data books for 1994-1995 Medicare mammography
utilization rates. This data can also be retrieved off of HCFA's homepage:
www.hcfa.gov/stats/mamm/mammover.lhtm In addition, 1995-1996 data is being released
in October.
Radio Public Service Announcements
HCFA is sending English and Spanish radio PSA scripts to radio stations nationwide that
target the older population. The PSAs were designed and tested by one of HCFA's Peer
Review Organizations.
Media Campaign
HCFA is in the midst of planning a media campaign to announce the expanded screening
mammography benefit in January or February. A possibility is to hold a one or two day
conference on breast cancer and mammography and to invite federal agencies, breast
cancer leaders and the press. In addition, HCFA will update its print and video materials
to reflect the message about new coverage for annual mammograms. Finally, HCFA will
aggressively pursue print, tv and radio coverage of the benefit change.
III.
Information on Medicare and Mammograms
The Health Care Financing Administration (HCFA) has developed a fact sheet and an
abstract regarding three programs related to breast health. Information about these
programs, the National Medicare Mammography 2000 Campaign, Preventive Screening
Services Project, and the Mammography HORIZONS Project, can be accessed at:
www.hcfa.gov/medicare/hsqb/hsqb3f.ltm (abstract)
www.hcfa.gov/medicare/hsqb/hsqb6f.litm (fact sheet)
Mammography data can be accessed at:
www.hcfa.gov/stats/mamm/mammover.htm
HCFA's Medicare Hotline (1-800-638-6833) provides information on Medicare coverage
of mammograms.
Contact:
HCFA Press Office at (202) 690-6145
HORIZONS MAMMOGRAPHY MEETINGS SUMMARY
The Health Care Financing Administration's (HCFA) National Medicare Mammog aphy
Campaign's goal is to reach at least a 60 percent utilization rate for Medicare-paid screening
mammograms for all female Medicare beneficiaries 65 and older by the year 2000. HCFA intends
to accomplish this goal in a way that assures equity participation among the diverse populations
served by the Medicare program which have lower than average utilization rates.
As part of the HCFA Horizons Program: Special Partnerships for Special Populations,
mammography projects are being launched in six major cities with low mammography utilization
rates to develop local partnerships in Hispanic American and/or African American communities to
increase these rates. The selected cities and populations are: Philadelphia- African American,
Atlanta-African American, Cleveland-African American, Chicago-Hispanic and African American,
San Antonio-Hispanic, and Los Angeles-Hispanic and African American. Together with HCFA's
Regional Offices and HCFA's contractors, the Professional Review Organizations (PRO), the
community-based partners will work together to plan and implement locally planned interventions
to increase the rates of screening mammograms for Hispanic and African-American Medicare
beneficiaries in these communities. The Mammography Horizons project is a 3- year
commitment by HCFA to increase the use of Medicare screening mammograms.
To help the communities with their planning, HCFA conducted market research in each city
examining the knowledge, attitudes and beliefs of beneficiaries and health care providers to better
understand the specific barriers to mammography utilization in those cities as well as identifying
breast cancer intervention programs and key stakeholders. The market research analysis was sent
to the stakeholders who were also invited to attend meetings in each of the cities to begin
planning appropriate interventions to be conducted by the PROs in collaboration with the
community-based partner organizations.
Although screening mammograms and outreach are provided by numerous organizations in each
city, local partnering has been very limited among these organizations and there have been very
few efforts directed at the African American or Hispanic Medicare beneficiaries. In each
community, the Horizons Mammography conferences provided a forum for participants to gain
knowledge abo each of the participating organiza ons and programs. The opportunity to
develop a shared vision to increase the utilization of screening mammograms for Hispanic and
African American Medicare beneficiaries was enthusiastically supported by virtually all of the
participants. A brief description of the meetings and preliminary ideas for local interventions for
each of the cities follows.
Cleveland, Ohio
The first of the six cities to hold a planning conference and "kick off" the Horizons
Mammography Project was held in Cleveland, Ohio, August 21, 1997. The primary goal of the
one day conference was to discuss the issues and barriers for Medicare beneficiaries and providers
that affect mammography use among Cleveland's over 65 year old female African American
beneficiaries. Participants included community and academic leaders from the Academy of
Medicine of Cleveland, the local chapter of the American Cancer Society, the Center for Health
Affairs, the City of Cleveland, the Cuyahoga County Board of Health, the Junior League, the
Minority Women with Breast Cancer Uniting, WUAB-TV 43, and multiple health care providers.
For 1994-95 the mammography utilization rates were 37 percent for African American Medicare
beneficiaries in Cuyahoga County. The market analysis conducted in Cleveland elicited
information about barriers to breast health for the targeted population which included:
transportation, child care, absence of a primary physician, lack of understanding of the Medicare
benefit, cost, fear of finding cancer and then, not having the financial resources to pay for
treatment, fear of radiation. The market research identified barriers in the provider population as:
a need for education on breast screening services; debate in Cleveland's medical community about
the need to acknowledge cultural and ethnic diversity and the effect on attitudes about preventive
care.
A follow-up meeting between the PRO and the conference participants was held September 17 to
begin development of the Horizons Mammography work plan. The wor¹: plan will include
effective interventions developed by the participants aimed at increasing utilization of the
Medicare screening mammography benefit among Cleveland's African American female Medicare
beneficiaries.
During the first year efforts will focus on educating beneficiaries about the Medicare screening
mammography benefit and the importance of getting annual mammograms. Other efforts will be
geared to the education of physicians about the Medicare screening mammography benefit and the
importance of referring women 65 and over for annual screening mammograms. Also during the
first year, the PRO and the community will plan additional interventions aimed at beneficiaries as
well as health ( re teams to be implemented during the : cond and third years.
Current and year one outreach and intervention activities in Cleveland include: participation in
health fairs, provision of mobile mammography units; community education; screening, detection
and treatment support services; and information dissemination to members of professional
organizations. Also included aΓe:
Kick-Off Events-- Receptions October 24 and 25, 1997 featuring National Spokes Person
Miss Black USA 1996, Dawn Moss, for the Hands For America Breast and Prostate
her
Cancer Awareness Program and Mayor Michael White; Give Me Your Hands Toget
0
Without Tears Breast Cancer Survivors Quilt Exhibit (Oct. 24-31), hosted by Metr
Health Clements Center for Family Care
American Cancer Society breast health telethon and Tell A Friend
Development of church health ministries coalition (focus on women's health/breast health
and awareness)
Development of breast health holiday greeting card
Provider education seminar on Medicare mammography coverage and beneficiary
communication strategies.
Beneficiary Interventions:
American Cancer Society-Tell A Friend Program
and Breast Health Telethon
Academy of Medicine's radio station (interview - message on telemed)
AARP newsletter articles
Nationwide Insurance to include in newsletters and/or benefit statements
Department of Aging newsletter - Senior Times
Display posters at senior centers and meal sites
Interactive Education al Presentations
Bells For Remembrance
Development of Church Health Ministries Coalition
Days of Caring and Sharing
Breast Bingo Play-Off
ACS Special Touch Training
Design Holiday Greeting Card with "Breast Heath Message"
Partnership with Flu Shot Programs (Breast Health material Distribution)
Media Campaign; PSA, newspaper articles, local transit and billboard advertisement, local
television coverage; Black History Month, (Feb.) Minority Cancer Awareness Month,
(April) Mother's Day, (May) Minority Health Month, (June) Women's Health Month,
(September) Breast Cancer Awareness Month, (October) Planning--Nov. / Jan.
Community HEALTHTalk Seminars
Senior Health and Beauty Action Group (Queen of SHeBA Group)
Adopt a Granny for Life-Youth to Elder; BSE Education Development and Training
Program
Provider/Physician Interventions:
Academy of Medicine publication (bimonthly) - distributed to physicians in Cuyahoga
County
Articles in OSMA publication and Buckeye Osteopath
Hospitals to include on agenda at medical staff meetings and include in newsletters
Professional Conference Exhibit Displays
Develop City-Wide Senior Women's Wellness Initiative for Geriatric Health Professionals
To learn further about linkages with the community, programs and services provided, past and
future collaborations, and results of breast health activities, the following organizations and
providers have agreed to participate in the project:
American Cancer Society
Greater Cleveland Hospital Association
Minority women with Breast Cancer Uniting
University Hospitals of Cleveland, Ireland Cancer Center
Encoreplus Program, YWCA of Cleveland
Office of Urban and Minority Health: Case Western Reserve University
Cuyahoga County Board of Health, Breast and Cervical Cancer Project
Hough Health Center
Olivet Institutional Baptist Church
NE Ohio Neighborhood Health Services
ODH, Breast and Cervical Cancer Project
Benjamin Rose Institute
St. Lukes Medical Center
Metro Health Systems Clements Community Health Center
Marymount Hospital
Ireland Cancer Center
Parma Community Hospital
Minority Health Alliance
The African American Cancer Support Group
Los Angeles, California
The Los Angeles Horizons Mammography Conference was held August 27-28, 1997. The
primary goal of the conference was to discuss the issues and barriers for Medicare beneficiaries
and providers that affect mammography use among Los Angeles' 65 and older female African
American and Hispanic beneficiaries. Approximately 100 participants attended this conference.
The following organizations in attendance represent a flavor of the audience and of the work
currently taking place in Los Angeles:
California State Health Department, BCEDP who seeks to impact mortality through the
quality of providers' training and standards and promoting screening and rescreening of
women.
California State Health Department, Breast and Cervical Cancer Control Program whose
goals are to influence provider training and practice, referral networks, and women
through community channels.
Encoreplus Program, Greater L.A. YWCA recruits and case manages women from
screening through diagnosis for breast and cervical cancer.
Mission City Community Network provides screening mammograms via a mobile van.
Watts Health Foundation is a community-based health clinic which provides screening and
diagnostic mamitiograms.
White Memorial Hospital Medical Center provides mammography and outreach to the
community.
Glaxo-Welcome is a pharmaceutical company that is beginning to get more involved in
research/advocacy and prevention efforts.
RAND Mammography Promotion in Churches Program encourages mammography
screening, identifies barriers to screening, and evaluates the effectiveness of a church-
based program for promoting screening.
The Edward R. Roybal Institute for Applied Gerontology partners with groups that
cultivate trust with ethnic communities to develop messages to encourage health
promotion and care-seeking among Latinos and African-American elderly persons.
University of Southern California, Norris Comprehensive Cancer Center works on a
mammography research project with five universities throughout the United States funded
by the National Hispanic Leadership Initiative on Cancer.
Urbai. Health Initiatives, Drew University IS conducting a survey on knowledge, attitudes,
and behaviors of African-American women related to breast cancer prevention and
emphasizes greater community involvement in defining agendas, research, and health
advocacy.
Women of Color Breast Cancer Support Project is an advocacy group which highlights
self-esteem, empowerment, and building motivation for health awareness and health
prevention practices.
Partner for Progress underscores the importance of organizations in the community
banding together to promote mammography screening.
Cancer Information Service
American Cancer Society
National Black Leadership Initiative on Cancer
Three types of sessions were the driving force of the conference. They were formal presentations,
panel discussions, including interviews with women in African-American and Hispanic
communities, and small group discussions. Dr. David Reuben, Chief, Division of Geriatrics,
University of California Los Angeles, School of Medicine discussed research-based insights on
barriers and how to overcome them. Dr. Mary Elina Ferris, CMRI, shared data showing
mammography rates in California based on Medicare claims data. Dr. Sarah Fox, RAND
Corporation shared data from Hispanic and African-American communities in Los Angeles. Jane
Cordingley-Klein, CMRI examined the marketing perspective of the Medicare population. In
addition to the sessions the keynote speaker, Christina Sanchez-Camino, Director, Public Affairs,
KMEX - Channel 34, shared personal experiences and insights into the effective use of Spanish-
language television to promote mammography screening in minority communities.
The panels discussed effective strategies and solutions to increase mammography screening in
Medicare Hispanic and African-American women from both a patient/population perspective and
a provider/systems perspective. The small group discussions also followed this format and were
successful in highlighting the significant barriers and possible solutions for these groups. The
following issues were discussed:
Lack of health care provider sensitivity is one of the most important reasons why older
African-American and Hispanic women do not have regular mammograms. Lack of cultural
sensitivity, distrust of the medical community, disrespect that providers display toward the patient,
and lack of provider sensitivity in communicating with women are major perceived barriers for breast
cancer screening among older minority women. Physicians' interpersonal and cultural styles influence
women's adherence to recommended cancer screening guidelines. Physicians who answer questions
and offer support are more likely to have satisfied patients who accept and follow clinicians
recommendations.
Physician recommendation is a major motivational factor for older women. The advice of a
trusted physician is a key factor for older women to get a mammogram. The overwhelming majority
of women who have mammograms have physician referrals. Unfortunately, physicians are less
inclined to refer women 65 and older for mammography, and even less with women 70 and older.
Health re providers need to be trained to be nore sensitive towards patient needs. Education
in medical schools about cultural sensitivity and communication is essential. Interns should learn more
about working with the elderly. Health care providers need to explain procedures before a exam and
be very sensitive to the woman's feelings during the mammogram. Physicians must be a patient
advocate and to work with patients to gain compliance.
Lack of knowledge of the Medicare Mammography benefit among older women. Providers and
beneficiaries do not clearly understand the Medicare Mammography benefit. A large proportion of
older women are not aware of the Medicare mammography benefit for women 65 and over. Some
are unsure about the co-payment percentage amount and the beneficiary eligibility requirements for
Part B.
Cultural attitudes and values discourage the use of mammography among older women.
Fear - Fear of pain and disfigurement associated with treatment. "Too old"- Some women believe
they are too old for mammograms or breast cancer. There is the notion that if women are post-
menopausal or not sexually active, they are less likely to get breast cancer. Embarrassment -
Women are not comfortable in touching or having breasts touched. Resignation - Having breast
cancer is equated with death. "It is in the hands of God" or "What is meant to happen, will happen."
Mistrust of the health care system is very pronounced. Lack of preventive attitude - Some women
tend to get health care only when they have developed clinical symptoms. Low vulnerability to
cancer. Perception of cancer risk is low because there are no symptoms of breast cancer.
Media campaigns should combat negative attitudes toward breast cancer screening and
misperceptions including: a) risk for breast cancer decreases after childbearing years, b) risk is
related to sexual activity, c) discovering breast cancer is a fearful experience, d) great pain must be
endured during screening procedure, and e) funds are not available to pay for treatment. Personal
testimonials influence women who are resistant and the message is very powerful coming from a
cancer survivor.
Older women reported major structural barriers to breast cancer screening: Transportation
and lack of social support (how to get there, someone to take them) are major problems. Child
care - Older women are the traditional care givers in families and many are assisting in raising their
grandchildren. Language is a barrier. Language is a problem in the Hispanic population as well as in
the African American community. Time - Not having enough time. Time away from work. Cost -
The cost of screening mammograms is a significant barrier to beneficiaries. Women live on fixed
incomes. Household requirements are more important than mammograms.
Older women do not understand the health care system and feel "out of place." There
are too many steps and layers in the system. Women want to make "one" call to get
assistance and "One-stop" comprehensive services.
Outreach and media campaign efforts should be focused on informing the public about
Medicare mammography guidelines, coverage and use. There is a need to develop a public
information campaign to inform older women and health care providers of the new annual Medicare
mammograph benefit and about the benefits of : ammograms. Electronic media such as
television and radio are major vehicles for health information.
Effective mammography screening interventions need to use multiple strategies to reach
elderly women. Effective outreach should also target populations outside the medical settings
include beauty shops, churches, and schools. Interventions should consider non-English speaking
populations, high risk populations, and underserved populations.
Communication messages that promote the use of annual mammograms must use
segmentation and be culturally sensitive. Communication messages need to be tailored to the
specific needs of the target group (e.g., images need to look like women being targeted). Education
materials must use appropriate images, address literacy level, use simple language, and have big print
for ages 65 and older.
There is a strong need to participate with national, State, regional community groups in the
promotion of breast cancer screening for elderly women. Effective partnerships include working
together with health care organizations such as California Medical Review, Inc. (CMRI), Health Care
Financing Administration (HCFA), Roybal Institute for Applied Gerontology; cancer programs such
as Breast Cancer Early Detection Program, Cancer Information Service, the American Cancer
Society; cancer coalitions such as the National Black Leadership Initiative on Cancer, Partnered for
Progress, National Hispanic Leadership Initiative on Cancer; and academic institutions such as the
University of California, Los Angeles, Drew Medical University, University of Southern California
and any other breast cancer community organizations.
The California Peer Review Organization in partnership with the community is planning an
educational campaign to inform women and health care providers about the importance of
mammograms for older women in Los Angeles County. In collaboration with national, State,
regional and community groups in order to improve routine screening mammograms among Los
Angeles county Medicare beneficiaries with a special focus on specific areas of the Los Angeles
County covering 10 percent of California's female Medicare beneficiaries where mammography
rates are lowest and African American and Hispanic/Latino beneficiaries reside. The campaign
efforts will:
target physicians and health care providers to advise older women about the importance and
value of early cancer detection and referral to cancer screening services.
develop and disseminate public information and culturally sensitive education materials related
to the detection and control of breast cancer to increase knowledge of and positive attitudes
toward mammography and reduce fear associated with cancer detection among California
Medicare-enrolled women.
work in partnership with community groups combining complimentary efforts.
A supportive mass media campaign will include radio and television Public Service
Announcements, newspaper articles and press releases explaining the new Medicare benefit and
the importance of mammography. Attractive educational materials will be developed. Messages
and materials will be crafted with the specific target populations in mind, paying particular
attention to cultural differences. The campaign logo his been wi, cly accepted among African
American and Hispanic women: "Get a mammogram every year. Do it for yourself. Do it for your
family."
Philadelphia, Pennsylvania
Approximately 120 person were in attendance at the Horizons Mammography conference on
September 4, 1997. The target audience for the Philadelphia project is African-American
Medicare eligible women age 65 and older. The one day conference focused on the barriers to and
the possible interventions for increasing the rate of mammography screening by this population.
Attendees included individuals local provider and beneficiary groups and organizations.
The conference agenda consisted of presentations on the National Medicare Mammography
Campaign, the background for the Horizons Mammography Project and the market analysis
conducted in Philadelphia. The honorable Marion Tasco, Ninth District Councilwoman addressed
the participants on the need for community partnerships and shared her enthusiasm and support
for the project. Breakout groups were held later in the day and were divided by the following
topic areas: Physician/Provider Interventions, Social/Recreational Interventions, Religious Setting
Interventions and Business Affiliated Interventions. Each of the groups discussed interventions
that could be used in the various settings and ways that they might go about implementing those
interventions.
Medicare Part B claims data reveal that only 40 percent of African-American women age 65 and
older in Philadelphia, PA received a mammogram in 1995. The market analysis in Philadelphia
revealed the following barriers perceived to be reasons for low mammography rates among
African American women age 65 and over:
Lack of Awareness - there appears to be a significant amount of lack of awareness about the
need for annual screening mammograms and the potential for successful treatment of breast
cancer.
Fear - the most visceral fear for the target population is discovering that they have breast cancer.
Other fears include fear of pain associated with the mammography screening procedure, not
knowing what to do if breast cancer is diagnosed, fear of disfigurement, and a fear that African-
Americans are more likely to be experimented upon.
Cost - more 'ducation fro beneficiaries and providers is needed about the Medicare-paid
mammography screening benefit. Cost related to transportation is also a concern.
Cultural Attitudes - an attitude that presents a major barrier is a kind of "fatalism" which leads
women to say that "the Lord will take care of me" or "what's meant to be is meant to be." There
is also a tradition that family comes first and therefore older women with low incomes will not
spend money on themselves for preventive care.
Transportation - although older Philadelphians can ride public transportation at reduced rates,
this is possible only during non-rush hours. Some participants stated that transportation can be an
issue because of cost, convenience, or perceptions of safety.
E
The major stakeholders in Philadelphia include:
PRO - Keystone Peer Review Organization
HMOs and Health Systems- Aetna/US Healthcare, Allegheny Health Systems, Mercy
Health Systems, North Philadelphia Health System, Qualmed, Spectrum Health Services
Breast Health and Cancer Organizations - Breast Health Institute, Cancer Information
Service, Linda Creed Breast Cancer Foundation, Living Beyond Breast Cancer
Sororities - Delta Sigma Theta Society, Lambda Kappa Mu Sorority
Universities - Lincoln University, Temple University, University of Pennsylvania (Cancer
Control, Research, Nursing and Radiology areas), Villanova University
Hospitals and Nursing Centers - Germantown Hospital, LaSalle Nursing Center,
State and Local Government - Philadelphia Department of Health, Pennsylvania
Department of Health, Pennsylvania Department of Aging, Philadelphia Corporation for
Aging, Philadelphia Department of Public Health, Mayors Commission to Services to the
Aging, City Councilperson Marian Tasco
African-American Organizations - Black History Month Committee, National Black
Women's Health Project
Consumer/Women's Organizations - Family Planning Council, Urban League of
Philadelphia, The Health Federation of Philadelphia
Health Centers - Strawberry Mansion Health Center, Chestnut Hill Health Care
Women's Center
Religious Organizations - Women of Faith and Hope
Current Outreach Activities already occurring in Philadelphia include:
Availability of reduced rates for public transportation during non-rush hours
Mobile mammography van operated by the City of Philadelphia Department of Public
Health
Free educational and prevention activities occur through numerous organization (e.g.,
medical center, American Cancer Society)
Availability of two comprehensive cancer centers (Fox Chase Cancer Center & University
of Pennsylvania)
Num rous mammography screening center (L' dr Creed Breast Cancer Foundation,
Philadelphia Corporation on Aging, etc.)
Breast cancer hotlines
Involvement of several African-American radio stations (WDAS, WHAT) & newspapers
(Philadelphia Tribune) as well as African-American churches
Circle of Friends activities -- small groups working together to discuss this taboo topic,
encourage women to obtain mammograms, etc.
At the Philadelphia Horizons Mammography Conference the following two interventions were
suggested:
Business Affiliated Interventions: Involve businesses within individual neighborhoods in
building sustainable local coalitions to encourage neighborhood residents to use the screening
mammography benefit; develop partnerships with large employers to spread the word, through
employee newsletters, to family members; work with utility companies to advertise messages, use
simple methods (colored "referral" slips provided by local businesses to track what influenced
women to obtain mammograms).
Religious Interventions: Begin working with mosques, pastors, and their health ministries
(including pastor's wives and church nurses) by involving them in the development and planning
processes; gather better information as to availability of public transportation (what organizations
offer it, phone #'s, working hours, pick-up/drop-off locations, etc.); develop listing of
organizations/ways to cover the 20 percent of the cost not paid for by Medicare; work with the
local media; develop one consolidated set of campaign materials supported by all multi-city
participants (including names of all organizations) and try to include some sort of scripture
reference (body is a temple, etc).
Atlanta, Georgia
The Atlanta Horizons Mammography Conference was held September 9, 1997. Approximately
100 participants attended this conference to discuss how to overcome barriers to mammography
use by African American Medicare beneficiaries. According to conference participants who were
representatives of community-based organizations, faith institutions, academic institutions,
physicians and mammography providers, and other individuals/agencies who work with older
African American women, the major barriers to routine mammography screening among this
target group are the following:
older African American women do not perceive themselves to be susceptible to breast
cancer
fears related to having a mammogram and the possibility of detecting cancer
lack of awareness about the importance of routine mammography for women 65and over
lack of access to the facility and transportation
lack of physician referral for mammogram
lack of, or under use of, trusted individuals to convey importance of annual mammograms
to African American women 65 and over
cost and variable reimbursement
lack of data and clear guidelines about mammography for women 70 and over
cultural attitudes and religious beliefs
competing concerns
inconvenience
co-morbid illnesses
cultural-communication barriers between physicians/providers and the women
lack of feedback for physicians on comparative performance
The metropolitan Atlanta community has many strengths in the diverse groups of organizations
that are working to reach older African American women with health-related information.
Churches and community-based organizations, including such groups as the American Cancer
Society, NBLIC, Reaching Out to Senior Adults (ROSA) etc., are engaged in various projects
specifically designed to reach African American women on mammography. Current outreach
activities in Atlan: 1 include:
Older Women's League- Fifteen metro women are conducting workshops in the community at
senior high-rises and senior centers stressing the importance of BSE, mammography, and clinical
breast exams.
East West Breast Express-the outreach program reached 2,029 women 16 Marta Stations
(Atlanta's Rapid Transit System) about the importance of mammography. They did clinical breast
exams and gave away coupons for marumograms.
Breast Health Education Study- Morehouse College presented a two pronged program. They
worked with public housing and also presented a play "Nightmare" to physicians. The play was
about a doctor that forgot to refer three women for mammograms and they all are later diagnosed
with breast cancer.
NBLIC- Instituted a formal outreach initiative to establish a national system that will increase
cancer prevention and control activities to reduce mortality in the black population.
Cancer Prevention Awareness Program-An intervention designed to increase awareness of
preventable cancer risk factors among African-American Atlantans. The program targets lung,
breast, prostate and colon cancer.
BEST Project-This project was developed to determine the efficiency of breast self examination
by using a modified version of the palmar surface and the ACS standard technique using finger
tips.
Project Awareness- The primary objective is to increase the number of African American and
other under served minority women to comply with the ACS breast screening guidelines. It has a
three tiered approach: (1) Education, (2) Easy Access to Affordable Screening, (3) Referral for
Follow up Care
Women's Health Enterprise- A non profit family nurse practitioner managed holistic health
program. They are committed to developing health care programs in response to the expressed
concerns of an under served community and offering these services to the citizens in the
community in which they reside. They accept Medicare and Medicaid reimbursements and offer a
sliding fee schedule. They do referrals to Breast Test and More as well as working with the ACS
Tell-A-Friend Program.
ROSA- Reaching Out for Senior Awareness is a coalition of black churches that has a large
outreach day every year. This year they presented an original play about mammography.
The 1995 mammography utilization rates for African American Medicare beneficiaries living in
Fulton and DeKalb Counties are 18.4 percent and 17.2 percent respectively. Of the 122 zip codes
in these 2 counties, 11 represent 72 percent of the total number of African American Medicare
beneficiaries for these 2 counties. These 11 zip codes had mammography utilization rates in
1995-96 ranging from 25 to 32 percent. These rates are still significantly lower than the Healthy
People 2000 goal of 60 percent as well as overall Medicare utilization rates.
The conference attendees felt that there needed to be more education about Medicare benefits
and educational programs concerning mammography procedures and early detection. Educational
material should be developed that is culturally, age and educational specific. They felt probably
the greatest impact is to have survivors deliver the education. They felt that the Witness program,
prompt to physicians, church sponsored programs and the use of university/high school students
to provide tr: resportation for community service ~redit Providers discussed the need to increase
referrals. All conference attendees expressed interest in participating at some level.
San Antonio, Texas
The planning conference for the Horizons Mammography Project in San Antonio was held on
September 11, 1997 to discuss locally based interventions for Hispanic American Medicare
beneficiaries. Particpants included 54 representatives from a variety of organizations involved in
breast health, the Hispanic community, and the 65 and older population, including:
American Cancer Society
Texas Department of Health Breast & Cervical Cancer Control Program
and other state agencies
YWCA Encore Plus
Susan G. Komen Breast Cancer Foundation
imaging centers
hospital systems
community health clinics
senior citizens groups
The conference presenters included Sylvia Fernandez, PhD, member and former chairperson of the
Governor's Commission for Women. A breast cancer survivor herself, Dr. Fernandez delivered a
positive, motivating presentation titled "An Invitation to Help Save Lives." The keynote address
titled "Organization: The Need for Community Partners" was given by Diana Rowden, Chairman of
the Susan G. Komen Breast Cancer Foundation, who is also a breast cancer survivor. She spoke very
eloquently about partnerships and how organizations can benefit from forming partnerships.
Participants were divided into two groups for concurrent breakout sessions. One group discussed
the barriers to mammography for Hispanic women 65 and older, while the other discussed barriers
to health care providers. Later, the groups switched topics in order to give attendees the opportunity
to participate in discussions on both beneficiary and provider issues. According to conference
evaluations, participants felt that these discussions were productive.
The events surrounding the San Antonio conference were unique in that only two weeks prior to this
date, many of the conference participants had attended the Breast Cancer Round Table sponsored by
American Cancer Society and other organizations. Round Table organizers allowed HCFA 15
minutes on their agenda to describe the Horizons Mammography project and invite participants to
attend the September 11 conference. Discussions at the Round Table event yielded valuable
information which provided a starting point for discussions at the Horizons Mammography
Conference. As a result, participants were not "starting from scratch" in identifying barriers to
mammography and possible solutions/interventions to overcome them.
During the discussions, participants confirmed the results of the marketing research conducted by
HCFA prior to the conference, particularly on issues such as the tendency of elderly Hispanic women
to rely on their church and the fact that both beneficiaries and providers need to be educated about
the Medicare mammography benefit. The latter issue, in fact, was one of the highlights of the
discussions, as providers and beneficiaries alike were pleased to be informed of the upcoming
changes in Medicare's coverage of screening mammography.
However, both provider- and beneficiary-oriented discussions had an overarching theme: The many
steps which take place from the time a Hispanic woman 65 or older hears a message about
mammograms or breast cancer to the time she receives her results must be carefully examined and
improved upon in order for more women to obtain mammograms on a regular basis. For example,
a woman who hears a public service announcement in English about mammograms may not
understand their life-saving potential if her first language is Spanish. If she does understand the
importance and actually calls to make an appointment for her first mammogram at a large health-care
facility, she may find it difficult to locate the mammography center, simply give up and never again
attempt to get a mammogram. If she finds the mammography center, but encounters a clinician who
is not able to explain the procedure in a language she can understand, she may get the mammogram
but never return for subsequent mammograms. Further, she may convey the negative experience to
her friends, who may as a result never make an appointment for a first mammogram.
These examples represent only a few of the issues participants discussed with regal 1 to improving
communication between health care providers and Medicare beneficiaries, specifically, Hispanic
women 65 and older. But many are already implementing strategies to overcome these types of
communication barriers. With the Horizons Mammography Project, local stakeholders will have a
forum to share their strategies, organize a work plan which incorporates those strategies, implement
them, and increase the overall mammography rate by the year 2000.
Participants were given forms which allowed them to choose their level of involvement (as
stakeholders, collaborators, or partners) and whether or not they wished to participate in a work plan
development meeting which will be held by TMF in San Antonio at the end of September. As of
Oct. 1, 1997, 18 organizations have responded that they wish to be involved in the project, including:
Alamo Breast Cancer Foundation
American Association of Retired Persons (AARP)
Barrio Comprehensive Family Health Care Center, Inc. (community health clinic)
Blue Cross and Blue Shield of Texas, Inc. (Medicare Part A)
Blue Cross and Blue Shield of Texas, Inc. (Medicare Part B)
Cancer Therapy & Research Center
HealthLink (Baptist Health System outreach program)
Methodist Healthcare Ministries (Methodist health system outreach program)
The Mujeres Project (health outreach program for Hispanic women)
Nix Health Care System
Radiology Associates of San Antonio
San Antonio Chapter of the Susan G. Komen Foundation
San Antonio Metropolitan Health District
Santa Rosa Health Outreach
South Texas Radiology Group, PA
University of Texas Health Science Center at San Antonio
Visiting Nurses Association and Hospice of South Texas
YWCA Encore Plus
Although the first few months of this project will be spent organizing the three year plan, this core
group of partners is planning a kickoff event in October, such as a press conference Early indications
are that the San Antonio media will respond favorably to our efforts. Two articles in support of the
project and the conference were published in the San Antonio Express-News on September 12 and
15, and on September 14, a 10:00 am news segment (on the local NBC television affiliate) titled "En
Mi Barrio" included footage from the conference and portions of interviews with conference
participants about the importance of mammograms among Hispanic women. Additionally, a reporter
from the local Univision (Spanish television) affiliate plans to profile the project in October.
Chicago, Illinois
The Chicago conference is scheduled for October 8 & 9 in Chicago. Over 100 key community and
academic leaders interested in breast cancer awareness and increasing mammography rates in the
Chicago African- and Hispanic-American populations have accepted an invitation to the conference.
The mammography conference agenda includes both national and local presenters who will inform
the conference attendees about the overall objectives and need for the Horizons Mammography
project, outcomes-based mammography project work previously performed in Chicago, and
mammography outreach programs and efforts currently underway in Chicago. The speakers and
invitees lists both include diverse representation of providers, physicians, academicians, breast cancer
survivors, advocates, coalitions, media, consumers, and government agencies. Stakeholder
introductions will be made, and networking will be promoted during lunch and breakout sessions.
The conference format will include presentations in the morning and minority-specific breakout
sessions during both afternoons. Minority-specific expert panels will be available during the breakout
sessions on day one, and discussions will be aimed at identifying barriers specific to minorities in
Chicago. Discussions during the break out sessions on day two will focus on partnership efforts to
overcome barriers and increase mammography rates.
In addition, the City of Chicago Public Health Department will hold their annual mammography "kick
off" at the Horizons Mammography conference. Information about free mammography programs
offered by the City will be given by the Commissioners of the Chicago Department of Public Health
and the Chicago Department on Aging. The Mayor Dailey's wife will also address the audience.
Of the 165,481 Chicago women enrolled in Medicare Part B during 1995, 52,285 were African-
American and 3,256 were self-identified as Hispanic-American. According to Part B claims data,
only 7,880 (15.1 percent) of the African-American women and 448 (13.8 percent) of the Hispanic-
American women received a mammogram during 1995. This data excludes women who do not have
Part B coverage, were enrolled in a Health Maintenance Organization, or received free services.
According to the Chicago area market analysis, barriers preventing older women from obtaining a
mammogram include lack of physician referral, la * of perceived risk of getting breast cancer, lack
of knowledge about the screening test or the guidelines for screening, and
misunderstandings about the Medicare mammography benefit.
Several organizations are involved in outreach activities aimed at Hispanic- and African-American
women. Several teaching facilities have conducted studies providing them insight into behaviors and
beliefs about breast cancer and the need for mammography. Some facilities and agencies have
ongoing programs in place geared toward access and cost issues with under-served populations.
Many agencies offer literature promoting breast health The Illinois Foundation for Quality Health
Care educates consumers through its speakers bureau, health fairs, and conferences.
The extent and limitations of existing programs and literature will be explored at the October
conference.
Mammography final rule - Revised Questions and Answers (10/23/97)
1.
How many women get mammograms, and when should they get them?
The National Cancer Institute (NCI) has estimated that during 1992, approximately 25 million
mammograms were conducted. Based on a recent survey of facilities, mammograms are currently
being performed today at the rate of about 41 million a year. Women should consult their
physicians to assess their personal risk for breast cancer and to develop an early detection plan.
NCI recommends that women over 40 with no increased risk (i.e., based on family history) for
breast cancer get mammograms every 1-2 years.
2.
Why is mammography important?
Breast cancer is the second leading cause of cancer deaths among women, after lung cancer. It is
estimated that by the end of this year, 180,000 - 181,000 new cases of breast cancer will be
diagnosed and that between 43,500 and 45,000 women will die from the disease. Early detection
of breast cancer will be diagnosed, typically involving breast physical examination, breast self
examination, and mammography, is the best means of preventing deaths that can result if the
diagnosis is delayed until the onset of more advanced symptoms. Mammograms can reveal breast
cancer up to two years before a woman or her doctor can feel a lump. More than 90 percent of
these early stage cancers can be cured.
3.
How effective are mammograms in detecting breast cancer?
While the quality of mammography has greatly improved and, under the final regulations, will
continue to get better, the technology is not perfect. Up to 20 percent of cancers may not show
up in a mammography examination. That's why women are encouraged to use the three tools that
are complementary and provide the best chance of early detection of breast cancer:
mammography, breast clinical examination by a health care provider, and monthly breast self-
examination.
4.
What is the potential effect of a poor quality or poorly read mammogram?
If the image quality is poor, the interpreter may miss a cancerous lesion at its initial stages. Such
false negative diagnoses can delay treatment and result in avoidable deaths. Poor quality
mammography can also lead to a false positive diagnosis, resulting in needless anxiety for the
patient, costly additional testing, and unnecessary biopsies.
5.
What significant problems existed prior to the enactment of the Mammography Quality
Standards Act?
Problems with the provision of quality mammography services was documented by a number of
studies prior to the enactment of the new law. These studies showed that the image quality
produced by some mammography facilities was less than desirable and mammography service
providers lacked adequate quality assurance programs. It was reported that historically,
approximately 30 percent of the facilities applying for accreditation failed on their first attempt to
meet the voluntary accreditation standards that were in place at that time. In addition, on a
nationwide level, there were no universal standards for providing safe, reliable, and accurate
mammography services. The Senate Committee on Labor and Human Resources held hearings on
breast cancer in 1992 and also found a wide range of problems with mammography practice,
including poor equipment, lack of quality assurance procedures, poorly trained radiologic
technologists and interpreting physicians, and lack of facility inspections or consistent
governmental oversight. This raised concerns about missed detections of breast cancer.
6.
What does MQSA provide for?
MQSA was passed on October 27, 1992, to establish national standards for mammography. The
law requires that after October 1, 1994, all mammography facilities, except facilities of the
Department of Veterans Affairs, shall be accredited by an approved accreditation body, and
certified by the Secretary of Health and Human Services. This authority to approve accreditation
bodies and to certify facilities was delegated by the Secretary to FDA, which has been
implementing the law under an interim rule authority provided by Congress.
7.
What are the requirements of the MQSA final regulations?
The final regulations substantially raise the standards for mammography personnel, equipment,
quality assurance and control, patient notification of results, the mammography medical report
and performance of the accreditation body. These standards are similar to the "temporary"
regulations that were in effect. However, some improvements have been made, for example,
the amount of training that physicians who interpret the x-rays must have has been increased. In
order to continue to operate lawfully, all facilities must be accredited, meet these higher quality
standards, and be inspected every year.
8.
When will the final regulations go into effect?
Most of the regulations will go into effect in 18 months, while some (equipment, quality control
tests) will be phased in from a period of 18 months to five years. This will allow personnel to
obtain training, purchase new equipment, and establish new procedures to comply with the rule.
2
9.
How did FDA develop the final regulations?
During the 90-day comment period for the proposed final regulations--which were published on
April 3, 1996--approximately 17,000 copies of the proposals were mailed to all concerned
organizations and individuals on FDA's mailing list, including every certified mammography
facility. Copies were also distributed by FDA personnel at professional meetings, and the
availability of the proposal was announced in Mammography Matters, an FDA newsletter. More
than 1,800 members of the public provided comments on the proposals, and additional input
resulted from eight meetings with experts from the National Mammography Quality Assurance
Advisory Committee.
10.
What has been the impact of the MQSA so far?
All fully-certified facilities have been inspected, and annual inspections have shown that overall,
mammography facilities are complying with the interim standards. The first year's inspections
from 1995-1996 showed that only 20 percent had serious or moderate findings, with only two
percent being serious. The second year's inspections have shown further improvement. So far,
fewer than one percent of facilities have been found to have serious problems. A recent GAO
report (still in draft) concludes that, overall, MQSA has had a positive impact on the quality of
mammography services.
11.
What are the estimated costs and benefits of the new regulations?
On the basis of information available so far, FDA estimates the annual cost of compliance with the
new rule at about $40 million. The higher standards are likely to help save 75 additional lives and
prevent tens of thousands of false positive examinations, a benefit whose estimated dollar value is
well over $200 million a year. The rule will also result in a small Medicare cost increase (less than
$10 million annually).
12.
How much do inspections cost per mammogram?
FDA estimates that inspections cost 35 cents per mammogram.
13.
What will be the effect of the new rules on the cost of mammography?
FDA had initially estimated that the cost of mammography could increase about $1.70 per
screening mammogram. Recent estimates have indicated an increase in usage of mammography,
from about 25 million in 1992 to about 41 million in 1997. This would result in an average cost
increase of less than $1.00 per screening mammogram. The average price of a screening
mammogram is about $90-100.
3
14.
How can I find out whether a facility is certified?
The names and locations of certified facilities can be obtained by calling the Cancer Information
Service at 1-800-4-CANCER (1-800-422-6237). The information is also available on the Internet
on FDA's home page at www.fda.gov/cdrh/dmqrp.html. All certified facilities must prominently
display a FDA certificate of their status
15.
Where can I find out more about MQSA?
You can call 800-838-7715, the "Mammography Quality Standard Act" hotline of FDA's
Division of Mammography Quality Standards and Radiation Programs, or check FDA's home
page at www.fda.gov/(drh/dmqrp.html on the Internet.
4
FROM:WUMENS
OFFICE
202-456-7311
PRGET05
RADIO ADDRESS
Friday, October 24, 1997
The following guests will be in the Oval office during the Radio Address:
Stephen Baldwin
Kennya Baldwin
Warren Batts Former Chairman & CEO, Tupperware Corporation
Carmella Bocchino - Vice President, Medical Affairs. American Association of Health Plans
Nancy Brinker - Founding Chair, Susan G. Komen Foundantion
Christine Brunswick- President, Greater Washington Baltimore Advocacy Group and Vice
President, NBCC
Becky Cain - President, League of Women Voters
Myrna Candreia - Director, Encore Plus, YWCA
Kay Childs - Vice President of Human Resources, Shaklee Corporation
Brian Connolly - Group Vice President, US Sales, Avon Products, Inc.
Nancy-Ann Min DeParle Deputy Administrator, Health Care Financing Administration
Margaret Dixon - President, AARP
Richard Dorff - President. Florida Association of Health Maintenance Organizations
Annette Drummond- - retired
Ronald G. Evens, MD - Chairman of the Board of Chancellors, American College of
Radiology
Debbie Feger-Papenfuss Creative Director, Provalent Communications
Kennetb Francese - Executive Director - - Compensation and Benefits, Chrysler Corporation
Michael Friedman - Lead Deputy Commissioner, Food and Drug Administration
Bettye Green - St. Joseph's Medical Center
Tim Hammonds - President and CEO Food Marketing Institute
VVJ
FROM:WOMENS
OFFICE
d02-456-7311
PHGE:07
Diana Parsell Rowden - Chairman of the Board, Susan G. Komen Foundations
Donna Sanborn - President. BE&K
Gino Santini - President, Women's Health Global Business Unit, Eli Lilly and Company
Manette Scheininger - Maidenform. Inc.
Phillip Schneider - Managing Director, Public Affairs, National Association of Chain Drug
Stores
James Schwaninger Vice President. Government Relations. JC Penney
Elizabeth Shannahan - Special Assistant to the HCFA Administrator
Tamar Small - President, Provalent Communication
Maureen Stratton - American Greeting, Director, Trade and Marketing Communication
Kathleen Swiger - Oncology Communications Manager, Zenecce Pharmaceuticals
Johnna Torsone . Chief Personnel Officer. Piuicy Bowes, Inc.
Patricia Underwood - National Secretary and Board of Directors, American Nurses
Association
Harold Varmus - Director, National Institues of Health
Frances Visco - National Breast Cancer Coalition
I'v' 00:07 OHT 18/07/01
Jane Hasselkus . Marketing Manager, Mammography, Easuman Kodak Company
Maria Hinestrosa - Nueva Vida
Carol Hochberg - SHARE Board Member
Florence Houn - Director, Division of Mammography Quality and Radiation Programs, Food
and Drug Administration
Joanne Howes - . Principal, Bass & Howes
Carolyn Jennings - Direct Selling Association
Debra Judelson, MD . President, American Medical Women's Association
Richard Klausner - - Director, NationalCancer Institute
Marie Langer. - NABCO member
Amy Langer - - Executive Director, NABCO
Freda Lewis-Hall, MD - Director, Lilly Center for Women's Health. Lilly Corporate Center
Juanita Lyle - Breast Cancer Survivor, American Cancer Society. Inc
Joanne Mazurki - Program Director. Avon's Breast Cancer Awareness Crusade, Avon
Products, Inc.
Eileen McGrath - Executive Director, American Medical Women's Association
Steven McMillan - Manager, Federal Government Affairs, Zenecca Pharmaceuticals
Michael Mennuti - Assistant Secretary, The American College of Obstetricians and
Gynecologists
Michele Mullaney - - Project Director. Provalem Communication
Julie Mulligan - Creative Director, 1 800-Flowers
Sue Muse President, Greater DC Chapter, Church Women United
William K. Ris, Jr. - Vice President, Government Affairs. American Airlines
Bruce Roberts - National Community Pharmacists Association
YES 89:85 THE
The following eyests will listen 10 the Radio Address in the Receivels Room and come into
the Oval Office following the Radio Address for the receiving line:
Helen Robinson
Ruby Jean Smith - aunt
Glenna Dougan - Bill Clark's office manager
Don Moak
Azile Moak
Judy Bacher
Alex Bacher
Andres Felipe Gomez
Ellen McCauley Gross . Georgetown classmate
Clare O'Callaghan
Joan O'Callaghan - sister
LaVerne Feaster (T)
Dan Pierce
Donna Pierce
Chase Owens
Bill Hurt
Sue Hurt
Michelle Savage
Cathy Slater (T)
Edwene Stevens McCollum - Steve Stevens' sister
Mary Waites Lewey - Edwene's mother-in-law
Weston McCollum Lewey . Edwene's niece
Sara Catherine Lewey - - Edwene's great-niece
Stephanie Streett
Adrienne Erbach - OMB
Dun Erbach - Jad
Sharon Erbach - mother
Lois Fotinakes grandmother
Dave Leavy - NSC
Daniel Leavy
Louise Leavy
Donald Leavy
Patty McGuire Leavy
178 RO:RT OHI 28/02/01
051-23 97 20:24 FROM:WOMENS OFFICE
d0c-456-7311
(U:65557
PHGE 109
Jim Leavy
Christopher Leavy
Edward Leavy
Kaitlin Leavy
Megan Leavy
BA Rudolph
Earle Leighton Rudolpb
Marjorie Holt Rudolph
Terry W. Shoffner
Karen Rudolph Shofner
Samuel H. Holt Shoffner
Earle Leighton Rudolph, Jr.
Earle Leighton Rudolph III
Peter Rudolph
Sue Rudolph
Anil Kakani . OMB
Hemlata Kakani - mother
Joslyn Mack - OMB
Bernice Mack - grandmother
Julia Mack - mother
Steve Mack - dad
National Mammography Campaign
National and Corporate Commitments
Update 10/23/97
National Commitments
Avon
Involvement of 425,000 sales representatives in woman-to-woman reinforcement
of mammography importance: distribution of 15 million consumer flyers.
Sales brochure message about mammography importance: 60 million print
impressions.
Continuation of funding for 250 community organizations that, through outreach
to medically underserved women, link them to Medicare and other mammography
services.
Eli Lilly
The Breast Education and Mammography Screening Center at its Indianapolis-
based corporate center is Indiana's only on-site mammography center dedicated to
employees, retirees, and spouses over the age of 40 and offers its services and
educational material free of charge.
The Lilly subsidiary PCS Health Systems, Inc. Is using its on-line information
system to communicate with nearly every U.S. pharmacy to encourage women age
65 and over to get their Medicare-covered mammograms every two years.
Zenecca, Inc.
Supports Initiative through the National Breast Cancer Awareness Month
campaign of which National Mammography Day, October 17, is a key component.
One of the first companies to provide on-site screening to its employees and has
developed a comprehensive guide to help any employer institute mammography
programs for their employees.
Corporate Commitments
American Airlines
Provide mobile mammography units for 100,000 employees during October.
Develop promotional materials for in-flight videos that educate passengers on the
value of early detection, including the MMI message.
Distributed information in honor of Breast Health Awareness Month through 3
mailings sent to 75,000 employees.
American Association of Health Plans
Encouraged and facilitated the distribution of MMI materials to consumers and
providers at state health fairs and clinics coordinated by member health plans
across the country.
Distributed information about the MMI to nearly 500 Directors of Communication
at member health plans and affiliate state HMO associations.
Published a public service announcement in the Novertber/December 1997 issue of
HealthPlan, a bi-monthly magazine with nearly 8,000 subscribers.
Showcased the MMI in the May/June 1997 edition of the Medical Affairs Issues
Report which reaches nearly 1,000 health plan chief executive officers and medical
directors.
Shared information about the MMI with AAHP's Women's Health Task Force, a
diverse group of health plans that oversee the development of the Women's Health
Initiative--which is identifying best practices/model programs in four critical areas
of women's health: breast cancer decision making/treatment, menopause/hormone
replacement therapy, domestic violence, and obstetrics/pregnancy care.
American Greeting
Present Point-of-Purchase display for use in Mother's Day cards that includes a
special "reminder"card in greetings that reaches 30,000 stores.
BE & K Engineering
Provided on-site mammograms for a nominal amount to employees, retirees and
their spouses along with other preventive tests during a annual wellness fair.
Chrysler Corporation
Conduct special corporation-wide education programs on breast cancer awareness.
This program is available at 32 Wellness Offices and 72 other corporate locations.
Distribute 7,000 Shower cards for breast self-examination.
Chrysler Times awareness feature on Initiative to reach over 200,000 employees
and retirees
"Tel-A Friend' notice posted in Chrysler locations encouraging employees to
telephone their mothers, sisters, friends, and co-workers to remind them of the
importance of mammography. For every person an employee calls, Chrysler will
award them one "Wellbuck (an incentive to Chrysler makes available to employees
to encourage a healthy lifestyle.).
Direct Selling Association
Coordinate efforts among over 2600 executives of direct sales companies to
produce materials regarding mammograms for circulation. This effort has the
potential to reach 6 million direct selling women through monthly magazines,
videotapes, audiotapes and payroll and bonus check mailings.
Eastman Kodak Company
Distribute information with Supplement piece in September/October Employee
Newsletter that reaches 50,000 retirees.
Distribute 2,000 posters to communities with Eastman Kodak plants as well as
making mammograms available at the worksite for Kodak employees.
Thousands of female employees at Colorado Plant given awareness pins and asked
10 distribute one to an older women,
001-23
WOMENS
OFFICE
11S)-9CH-2028
Florida Association of Health Maintenance Organizations
Conducted free mammograms at the state capitol in March and at Florida area
malls the first weekend of each month
Provides a toll free telephone number for breast screening information and to
request educational materials. Encouraged worksite programs to their employer
customers.
Food Marketing Institute
Develop brochure with National Cancer Institute, National Urban League and the
U.S. Department of Health and Human Services. The National Urban League will
distribute to 114 National Urban League affiliates. The Food Marketing Institute
will distribute to 1500 members including their subsidiaries--food retailers and
wholesaler and their customers in communities across the country.
J.C. Penney
Distribute information through insurance policy holder newsletter that reaches 1
million people.
Distribute message in October credit mailing that reaches 15-20 million.
Distribute material through Eckerd Drug Stores that reaches 2800 stores.
Maidenform, Inc.
Place 11/14 posters/signs with MMI message in dressing rooms in 100 outlet
stores for Mother's Day.
National Association of Chain Drug Stores
NACDS member pharmacies will participate with American Greetings in a special
Mother's Day outreach program, as well as provide information to 88,000 chain
pharmacists in over 30,000 chain operated community pharmacies about the
Medicare benefit and referral sources.
National Community Pharmacists Association
Publish article. including availability of materials, in October 1997 NCPA Annual
Convention issue of America's Pharmacist. Will reach nearly 40,000 independent
community pharmacies via mail. An additional 5,000 issues are distributed on-site
at the October '97 annual convention.
Publish article on the Initiative in October '97 issue of the NCPA Newsletter.
Announce the White House Medicare Mammography Initiative during the General
Session of the NCPA Annual Convention in Denver,, October 25-29, 1997. More
than 5,000 attendees Distribute material in Convention Press Room and in the
Convention Exhibit Hail
Post information on the Initiative on the NCPA web site [www.mepanet.org]
Broadcast programming, ads, or general announcement on our soon to be
launched in-store relevision network NPTV. which will reach hundreds of
pharmacies and hundreds of thousands of consumers.
WOMENS
Pitney Bowes
Provide on-site mammograms for female employees over 35.
Work with area hospitals on providing mammograms for uninsured and indigent
women'
Shaklee Corporation
Mailed notices to its 14,000 independent distributors and to all its employees
alerting them to Breast Cancer Awareness Month.
The Longaberger Company
For every Horizon of Hope Basket purchased, the company donates $2.00 to
breast cancer research and education awareness project. Each basket contains a
reminder sticker for an annual mammogram that reaches over 2.5 million women
Publish article on the Initiative in Company newsletter that reaches 40,000 sales
representatives.
Tupperware Corporation
Sent memorandum 10 approximately 1,000 U.S.-based Associates on the
importance of regular mammograms and highlighting women 65 and older and the
Initiative
Develop poster with Initiative message to be highlighted at the Tupperware's U.S
Distributor Conference which reaches 350 franchised distributorships supporting
the sales force in the U.S.
Publish article on Initiative in Distributor Bulletin insert that is distributed to the
entire U.S. sales force, of approximately 100,000 women.
1-800-Flowers
Develop a mailer insert with the Initiative message that will be included in a
reminder package to be sent to approximately 18,000-20,000 consumers.
OFFICE
Medicare Mammography Initiative
Editors' Commitments
10/24/97
WOMEN'S MAGAZINES
Child
Pamela Abrams
Plans to include article in November
issue.
Circulation: 740 thousand.
Cosmopolitan
Bonnie Fuller
Plans to include a large feature in
October issue ("A to Z" of
Breast Cancer).
Circulation: 2 million.
Elle
Elaina Richardson
Plans to include MMI article in
October issue.
Circulation: 900 thousand.
Family Circle
Susan Ungaro
Plans to include a report on
breast cancer in October
issue.
Circulation: 5 million.
Fitness
Sally Lee
Plans to address MMI in October
issue.
Circulation: 750 thousand.
Good Housekeeping
Diane Salvatore
Plans to address breast cancer and
MMI in October. November
editor's article will address
MMI.
Circulation: 5 million.
Healthy Living
Rachel Newman
Plans to print an article on MMI in
Country Living
the November issue.
Provides free mammograms to
employees.
Circulation: 1.6 million
Ladies' Home Journal
Susan Crandell
Plans to cover MMI in October issue
Circulation: 17 million.
Latina
Patricia Duarte
Plans to run feature article in either
November or December
issue.
Circulation: 300 thousand.
Mademoiselle
Elizabeth Crow
Plans to cover MMI in October issue
Circulation: 13 million.
McCall's
Sally Koslow
Plans to include major medical piece
on breast cancer in October
issue.
Circulation: 4.3 million.
Parenting
Janet Chan
Plans to discuss breast self-
exams in October issue.
Circulation: 1.1 million.
Parents
Sarah Mahoney
Printed article on Breast
Cancer and MMI.
Circulation: 12 million.
Redbook
Kate White
Plans to include 3 feature article in
September and an OB/GYN
column in October on breast
cancer.
Circulation: 13 million.
self
Rochelle Udell
Plans to include 16 pages on MMI.
Vice-President involved.
Circulation: 1.16 million.
Seventeen
Meredith Berlin
Plans to print MMI article in October
issue.
Circulation: 2.4 million.
Vogue
Anna Wintour
Plans to run an article on MMI in
Mary Murray
September issue.
Circulation: 1.19 million
OFFICE
10/03/97 WED 17:35 FAY
PROVIDENT
Candice Bergen:
FOR HUNDREDS OF THOUSANDS OF AMERICAN WOMEN, COPING WITH
BREAST CANCER IS A FACT OF DAILY LIFE ONE THAT THEY DEAL WITH
WITH COURAGE, DIGNITY. AND AT TIMES EVEN HUMOR.
FOR MOST WOMEN, A REGULAR MAMMOGRAM IS A CLEAN BILL OF
HEALTH. FOR OTHERS IT CAN BE THE BEST AVAILABLE TOOL FOR
DISCOVERING THE DISEASE EARLY, WHEN IT IS EASIEST TO TREAT.
I OUT OF 8 AMERICAN WOMEN WILL BE DIAGNOSED WITH BREAST
CANCER IN HER LIFETIME-WITH AGE THE LEADING RISK FACTOR.
SO USE YOUR HEAD AND YOUR HEART AND GET A MAMMOGRAM.
Mrs. Clinton:
(video taped wrap-up)
FROM:WORKS
VALENT
001 Oxford Vailey Road
Eldg 1503
ommunication
PA 10007
Tol (215)
Fox (215) 321-8103
(Stephen Baldwin reading the paper. Moners watering plants or other
activity.)
Mom, this article says that most women your age don't get regular mame
even
though age is the leading risk factor for beast acer.
My Danny. He's so smart.
No mom, I'm not Danny It goes OD to say that 180,000 new cases of breast cancer
will be diagnosed this year, over half of them in women over 65.
My Billy, he's so good with numbers.
Mom, get it straight, I'm not Bill
And starting January 1, Medican ys for
mammograms for women 65 and over. Now there's no excuse!
Alec. You'r SO compassionate
(Stephen puts down the paper and addresses Ss moth STectionately)
Mom. there's one thing you always get right...
encouraging women 10
regular
mammograms because early detection can save lives.
(Mrs. Baldwin reaches over and hugs Stephen)
I never confuse the import Stephen.
A member of the OCC Group of companies
700 5
VALENT
301 Oxford Volley Road
time 1503
communicat
PA 19067
tol (215) 321-4000
in (215) 321-4104
National Mammography PSA
Script for Whitney and Bissy Houstoh
(Open on Grandmother Playing with Grandchild)
Sissy Houston:
Honey. how was the baby's check-un?
Whitney:
Just fine Mama More importantly how about your mammogram?
Sissy:
Everything was just finemand my Medicoam benefit helped pay for it 100.
Whitney:
Great mama. Just remember that Medicare now helps pay for mammograms ever year so
make an appointment now for your manumogram for next year.
Sissy:
Girl...you can be such a nag. I guess it must be use. We all turn into out mothers
eventually.
Whitney:
Then it's a good thing that TY mame's so awarome.
A member of the OCC Group of companies
INTERNATED
IT:ST CER
000
Delied doldi UFFILL
ROVAL
301 Osford Valley Date
fldg 1503
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Turdley. PA 19007
it 1215) 321-411
For (215) 321-4103
White House Mammography Campaign
Celebrity TV PSA : 30
Final 10 second wrap
Mrs. Clinton:
BE SURE THE FIRST LADY IN YOUR LIFE KNOWS ABOUT THE
IMPORTANT NEW BENEFIT THAT PAYS FOR ANNUAL SCREENING
MAMMOGRAMS FOR ALL MEDICARE ELIGIBLE WOMEN AND
OLDER.
ENCOURAGE HER TO ORT A MAMMOGRAM IT'S A PICTURA AT CAN
SAVE HER LIFE.
A member of the OCC Group of completes
too (7)
31
10/23/67 THU 17:36 FAX 202
National
Breast Canchr Awareness Month 997
fy
States of America
smalled
Every year we
the
month
of
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10
our national
commitment to exadicate
it.
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for
merican women and their 5am
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decade
Dearly
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ow stectost
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knowledge about
Unioistration has established
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the country in 8 collaborative
find out more
about the disease
The Department
aking the lead la this nation
uch education
and
and Rasearch:
through nation
at the Contors for Disease
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Food and Drug Administra
sh prevention
services and
increased
accoss 10 clinics
and beneficiaries
of Defense
and Dupartment
of
Deformed
Dated a brosst
cencer research
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the quality of life
We CAR be
of the most promising
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a
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The National Cancer
erican Cancer
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10/23/97 THU
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friends can
live long. bealthy
NOW. THEREFO:
Frident of the United States
Inverice. by virtue
of the authority
and 16-5 of the United Stat
hereby proclaim
October 11147 A:
Mores ! call upon
usuals. businesses
communities. :-
cluntrons. and all the people
United States
in refiser CAMP
our knowledge about breast
and 10 publicly
realize our nation
this disorse.
[N WITNESS WHEREOF
hand this first day of Octol
2.e year of 0.1"
Lotd Director
79
Americ:
the its hundred
are
09/21/1997
PAGE 03
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all women over 401
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