[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

EXAMINING THE APPROPRIATENESS OF STANDARDS FOR MEDICAL IMAGING AND
RADIATION THERAPY TECHNOLOGISTS
=======================================================================
HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

SECOND SESSION

__________

JUNE 8, 2012

__________

Serial No. 112-150

[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov

__________

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California TAMMY BALDWIN, Wisconsin
CHARLES F. BASS, New Hampshire MIKE ROSS, Arkansas
PHIL GINGREY, Georgia JIM MATHESON, Utah
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California
GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin
LEONARD LANCE, New Jersey Islands
BILL CASSIDY, Louisiana KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

Subcommittee on Health

JOSEPH R. PITTS, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois EDOLPHUS TOWNS, New York
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina LOIS CAPPS, California
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
PHIL GINGREY, Georgia TAMMY BALDWIN, Wisconsin
ROBERT E. LATTA, Ohio MIKE ROSS, Arkansas
CATHY McMORRIS RODGERS, Washington ANTHONY D. WEINER, New York
LEONARD LANCE, New Jersey JIM MATHESON, Utah
BILL CASSIDY, Louisiana HENRY A. WAXMAN, California (ex
BRETT GUTHRIE, Kentucky officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

(ii)
C O N T E N T S

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Page
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 4
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 4
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 5
Hon. John Barrow, a Representative in Congress from the State of
Georgia, opening statement..................................... 6
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6

Witnesses

John Spiegel, Director, Medicare Program Integrity Council,
Center on Program Integrity, Centers for Medicare and Medicaid
Services, Department of Health and Human Services.............. 36
Prepared statement........................................... 39
Leonard Gunderson, Chairman, Board of Directors, American Society
for Radiation Oncology......................................... 45
Prepared statement........................................... 47
Rebecca Smith-Bindman, Professor of Radiology, Epidemiology/
Biostatistics, Obstetrics, Gynecology, and Reproductive
Sciences, University of California, San Francisco School of
Medicine....................................................... 57
Prepared statement........................................... 60
Sal Martino, Chief Executive Officer, American Society of
Radiologic Technologies........................................ 74
Prepared statement........................................... 76

Submitted Material

Statement, dated June 8, 2012, of Lynne Roy, Chair, Scope of
Practice Task Force, Society of Nuclear Medicine Technologist
Section, submitted by Mr. Pitts................................ 8
Statement, dated June 8, 2012, of American College of Radiology,
submitted by Mr. Pitts......................................... 14
Letter, dated June 7, 2012, of John J. Mahmarian, President,
American Society of Nuclear Cardiology, to Mr. Pitts, submitted
by Mr. Pitts................................................... 21
Letter, dated June 23, 2009, of David W. Parke II, Executive Vice
President, American Academy of Ophthalmology, to Senate Finance
Committee members, submitted by Mr. Pitts...................... 23
Statement, dated June 8, 2012, of Gary A. Ezzell, President,
American Association of Physicists in Medicine, submitted by
Mr. Pitts...................................................... 25
Statement, dated June 8, 2012, of Medical Imaging & Technology
Alliance, submitted by Mr. Pitts............................... 29
Statement, dated June 8, 2012, of Donald Haydon, Chief Executive
Officer, Society of Diagnostic Medical Sonography, submitted by
Mr. Pitts...................................................... 32

EXAMINING THE APPROPRIATENESS OF STANDARDS FOR MEDICAL IMAGING AND
RADIATION THERAPY TECHNOLOGISTS

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FRIDAY, JUNE 8, 2012

House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10 a.m., in room
2322, Rayburn House Office Building, Hon. Joseph R. Pitts
(chairman of the subcommittee) presiding.
Members present: Representatives Pitts, Burgess, Whitfield,
Blackburn, Latta, Lance, Guthrie, Pallone, Engel, and Waxman
(ex officio).
Also present: Representative Barrow.
Staff present: Andy Duberstein, Deputy Press Secretary;
Ryan Long, Chief Counsel, Health; Katie Novaria, Legislative
Clerk; John O'Shea, Senior Health Policy Advisor; Chris Sarley,
Policy Coordinator, Environment and Economy; Heidi Stirrup,
Health Policy Coordinator; Alli Corr, Democratic Policy
Analyst; Amy Hall, Democratic Senior Professional Staff Member;
and Anne Morris Reid, Democratic Professional Staff Member.
Mr. Pitts. The subcommittee will come to order. The Chair
recognizes himself for 5 minutes for an opening statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Today we are addressing the quality of medical imaging and
radiation therapy services and their impact on patient safety
and cost. I am sure that many people would be surprised to
learn that there are no uniform licensure standards for the
technologists who perform tests such as MRIs and CT scans every
day in our country. Currently radiologic technicians are
regulated at the State level and those standards can vary
widely between States, from those with stringent standards to
those that do not regulate the education or competency of these
medical professionals at all. Patient safety can be impacted by
improper positioning or poor technique by the technician, which
can lead to misreading of scans and a need for duplicate tests.
These tests cost Medicare billions of dollars every year, and
we cannot afford to pay for multiple tests that should have
been done right the first time.
I am a firm supporter of a bill by our colleague Ed
Whitfield, H.R. 2104, the Consistency, Accuracy,
Responsibility, and Excellence in Medical Imaging and Radiation
Therapy Act, or the CARE Act. This commonsense bill enjoys
bipartisan support and has been the subject of three hearings
in this subcommittee over the last few years.
It would direct the Secretary of HHS to, one, establish
minimum standards for personnel who perform, plan, evaluate, or
verify patient dose for medical imaging examinations or
radiation therapy procedures; two, establish a program for
designating certification organizations after consideration of
specified criteria; three, provide a process for the
certification of individuals whose training or experience are
determined to be equal to or in excess of those of a graduate
of an accredited educational program; and fourthly, publish a
list of approved accrediting bodies for such certification
organizations. Medicare reimbursement will be contingent on
meeting the minimum training standards.
I know that we have witnesses representing imaging and
radiologic technicians here with us today. And I look forward
to their insight and expertise in this area and their thoughts
on the CARE Act. I would like to thank all of our witnesses for
being here, and I look forward to your testimony. And at this
time I yield to the gentleman Mr. Whitfield.
[The prepared statement of Mr. Pitts follows:]
[GRAPHIC] [TIFF OMITTED] T0393.001

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

Mr. Whitfield. Thank you very much, Mr. Chairman. I
genuinely appreciate you and Ranking Member Pallone working
with us on this important legislation. I certainly want to
thank Mr. Barrow who is a cosponsor of this legislation, a lead
cosponsor of this legislation.
All of this started--at least for me--a couple of years
ago, I guess in 2010, when we had a hearing and we had some
people here involved in linear accelerators, and there was a
case up in New York where the patient was severely burned. And
as a result of that hearing, it came to our attention--although
I am sure people like Dr. Gunderson and Dr. Martino knew this
already--but it was quite obvious that all States do not
require licensing for these technologists. And those States
that do, frequently the standards are quite different.
So the purpose of this legislation is simply to ensure that
patients undergoing imaging or radiation therapy can feel
comfortable that the personnel performing those procedures are
qualified to do so. We have approximately 130 cosponsors of
this legislation, and I think it is an important piece of
legislation. And, hopefully, I look forward to working with all
of the members of this subcommittee and the full committee to
try to get this legislation to the floor as soon as we possibly
can. Thank you.
Mr. Pitts. I will yield the remainder of the time to the
vice chairman, Dr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS

Mr. Burgess. I thank the chairman for yielding. Both
radiation therapy and medical imaging are important. Critical
medical advancements, when used properly, save lives and should
be used only when necessary and utilized properly to employ the
safe use of radiation.
That is kind of where the similarities end. Radiation
therapy is just that. It is a treatment. Imaging is a screening
tool. It is the difference between taking a picture and doing
an operation. With medical imaging our goal, the goal should be
to employ the lowest radiation while achieving the clearest
picture. The therapy is to employ the most concentrated dose
and achieve the goal of killing the tumor.
With imaging radiation as a secondary thought, well, with
therapy it is actually the tool that is used. In developing
this--looking at our file cabinet under ``R'' and pull up the
first two things that contain radiation and trying to lump them
together may not be in the best interest, but there is no
question that they both need to be properly utilized.
Once again our approach is to two very different areas to
address different issues. Certainly we should do everything in
our power to make certain that providers, whether that be
hospitals or doctors, reduce redundancy and only take an image
one time if indeed only one image is indeed necessary. The
creation of radiation benefit managers is something that
concerns me and it is a clear way to achieve denial of service
rather than enhancement of service.
On the therapy side, we need to look at the improved
technological safeguards, increase medical education, specialty
society accreditation, as was mentioned by the chairman, and
coordination of medical professionals.
Mr. Chairman, I thank you for the consideration. And I will
yield back the balance of my time.
Mr. Pitts. The Chair thanks the gentleman.
I now yield to the ranking member, Mr. Pallone, for 5
minutes for an opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. Pallone. Thank you Chairman Pitts. Today the
subcommittee is meeting to discuss the appropriateness of
standards for medical imaging and radiation therapy
technologists. I am glad that we are having this hearing
because it is an important patient safety issue.
When I was the chairman, we held a hearing on the overview
of medical radiation, and Mr. Whitfield talked about it. And
that was in response to a series of alarming reports in The New
York Times on medical radiation errors. Those stories raised
red flags, and I felt it was important that members have an
opportunity to better understand the landscape. What we learned
at that hearing was critically important in that there were
gaps in the oversight of certification and licensing of allied
health professionals. We also determined, however, that
radiation undoubtedly saves lives because it has reshaped the
world of diagnostics and has offered patients less invasive
alternatives for treating complex and life-threatening
conditions.
In addition, a direct result of the examination of this
subcommittee has led to a number of efforts underway within the
imaging field. In 2010 the FDA launched the initiative to
reduce unnecessary radiation exposure for medical imaging, and
working with manufacturers to improve the safety of imaging
equipment through its regulation authority.
In addition, in 2010, through the Medical Imaging &
Technology Alliance, or MITA, manufacturers developed the CT
dose check standard which includes features that assist an
imaging team in providing better care. In addition, MITA is
currently finalizing the CT access control standard which will
produce an extra safeguard that will ensure only an authorized
operator can alter the controls of a CT scanner. These efforts
are commendable and should continue and be expanded.
But there is clearly still work to be done to better ensure
that the driving factors of why things go wrong are rectified.
One issue that still remains is licensure and certification.
While advancements in the industry become more complex and
complicated to operate, in many States, individuals who operate
these devices do not need to be licensed and are, therefore,
not regulated at all in terms of education and expertise. Even
in States where there are licensing requirements, the
requirements are weak and not enforced. And I just don't think
that is acceptable.
So that is why Representatives Whitfield and Barrow have
introduced the CARE Act, a bill that would establish standards
for the personnel who perform medical imaging examinations or
radiation therapy procedures. This seems like commonsense
policy and a legitimate first step in addressing radiation
safety. And I hope that the subcommittee will consider that
bill in the near future, Mr. Chairman.
What we also know is that we have no idea how often errors
occur and have no good data on where the weaknesses in the
system truly are. So I do think there is a need to find ways to
ensure that patients do not receive radiation doses in excess
of recommended levels. I look forward, Mr. Chairman, to hearing
from all our witnesses. We appreciate your taking the time to
speak to the subcommittee on this very important issue.
And I would like to yield the remainder of my time to the
gentleman from Georgia who is the Democratic sponsor of the
legislation, the CARE Act.

OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA

Mr. Barrow. I thank the chairman and I thank Chairman Pitts
and especially Chairman Whitfield for his leadership on this
issue. I am glad we are having this hearing to shine a light on
the fact that not all the folks performing radiation
diagnostics and treatment are properly trained. Many people I
represent are shocked to hear that. They know that it is a
direct threat to public health when radiation technology is
misapplied, and it is also an economic problem because of the
direct and indirect costs of poor image quality.
Along with Chairman Whitfield, I am the lead cosponsor of
the CARE Act which will address this issue by requiring a
standardized certification process for radiologic
technologists. I think that is common sense, and I hope and
expect it would be the consensus and position of this
committee. I look forward to hearing from the witnesses and
hopefully to moving this bill forward. With that, Mr. Chairman,
I yield back the balance of my time.
Mr. Pitts. The Chair recognizes the ranking member of the
full committee, Mr. Waxman, for 5 minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Mr. Waxman. Thank you very much, Mr. Chairman. The focus of
today's hearing, the accreditation of medical imaging and
radiation therapy technologists, suggests that the
certification process is key to maximizing patient safety when
radiation delivery is involved. Accreditation of personnel may
be an important component of patient safety, but as we learned
at this subcommittee's hearing on medical radiation in the last
Congress it is not the silver bullet.
Let me be clear at the outset: Diagnostic and therapeutic
radiology interventions save lives and improve health outcomes.
They are important procedures in our medical toolbox that
unquestionably have made our health-care system better. CT
scans minimize the need for exploratory surgery. Radiation
therapy aids in the treatment of other breast and other forms
of cancer. Even the basic X-ray plays a critical role in modern
medicine. But with this technology comes an important
obligation: making these interventions as safe as possible. Of
course that includes qualified technologists, but it also means
the delivery of the right procedure at the right time and with
an appropriate dose of radiation. Patients are entitled to
nothing less.
Since we last met on this topic, there have been some
notable advances in the public and private sectors alike.
Consider the following: CMS has developed an accreditation
process for physicians and other nonhospital providers who bill
Medicare for advanced imaging services. The FDA has launched an
initiative to reduce unnecessary radiation exposure in medical
imaging. And several professional societies are working to
communicate best practices to health professionals and patients
and to begin to capture data on the amount of radiation
patients are receiving.
These efforts should be commended and continue to move
forward, yet deficiencies still exist. We find only a patchwork
of State regulation for the technologists who position patients
and deliver radiation doses. And far too many patients continue
to receive radiation doses in excess of recommended levels.
Today's hearing will examine all of this, hopefully with an
eye on the ultimate prize: ensuring that all medical radiation
services are designed, delivered, and monitored with the
highest quality of care. I look forward to hearing from our
witnesses this morning and I thank each of you in advance for
your testimony. Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman.
That concludes opening statements for the members. The
Chair requests unanimous consent the following statements be
introduced into the record: a statement of the Society of
Nuclear Medicine Technologists section; a statement of the
American College of Radiology; a statement by the American
Society of Nuclear Cardiology; a statement of the American
Academy of Ophthalmology; a statement of the American
Association of Physicists in Medicine; a statement of the
Medical Imaging & Technology Alliance; and a statement of the
Society of Diagnostic Medical Sonography. Without objection, so
ordered.
[The information follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

Mr. Pitts. I will introduce the panel at this time.
Today's witnesses are Mr. John Spiegel, who is the director
of the Medicare Program Integrity Group at the Centers for
Medicare and Medicaid Services, United States Department of
Health and Human Services; Dr. Leonard Gunderson, chairman of
the board of directors for the American Society for Radiation
Oncology, and emeritus professor and consultant in radiation
oncology at the Mayo Clinic; Dr. Rebecca Smith-Bindman is a
professor in the departments of radiology and biomedical
imaging, epidemiology and biostatistics and obstetrics,
gynecology, and reproductive sciences at the University of
California San Francisco; and Dr. Salvatore Martino is a
registered radiologic technologist and is the chief executive
officer for the American Society of Radiologic Technologists.
We are happy to have all of you with us today. Your written
statements will be made part of the record. And at this time
you are recognized for 5 minutes each to summarize your
testimony.

STATEMENTS OF JOHN SPIEGEL, DIRECTOR, MEDICARE PROGRAM
INTEGRITY GROUP, CENTER ON PROGRAM INTEGRITY, CENTERS FOR
MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES;
LEONARD GUNDERSON, CHAIRMAN, BOARD OF DIRECTORS, AMERICAN
SOCIETY FOR RADIATION ONCOLOGY; REBECCA SMITH-BINDMAN,
PROFESSOR OF RADIOLOGY, EPIDEMIOLOGY/BIOSTATISTICS, OBSTETRICS,
GYNECOLOGY, AND REPRODUCTIVE SCIENCES, UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO SCHOOL OF MEDICINE; AND SAL MARTINO,
CHIEF EXECUTIVE OFFICER, AMERICAN SOCIETY OF RADIOLOGIC
TECHNOLOGISTS

Mr. Pitts. Mr. Spiegel, you are recognized for 5 minutes.

STATEMENT OF JOHN SPIEGEL

Mr. Spiegel. Thank you. Chairman Pitts, Ranking Member
Pallone and members of the subcommittee, I am pleased to be
here today to discuss the role of the Centers for Medicare and
Medicaid Services and accrediting suppliers of advanced
diagnostic imaging services. CMS is working to ensure that
Medicare beneficiaries receive advanced diagnostic imaging
services from suppliers that meet quality and safety standards.
Section 135 of the Medicare Improvements for Patients and
Providers Act of 2008, or MIPPA, requires that beginning
January 1, 2012, Medicare can only make payments to the
supplier of the technical component of advanced diagnostic
imaging services if the supplier is accredited, including
personnel standards, by an accrediting organization approved
and designated by the Secretary of the Department of Health and
Human Services.
CMS has implemented these statutory provisions. This
advanced diagnostic imaging accreditation requirement applies
to MRI, CT, nuclear medicine, including PET. The law also gives
the Secretary flexibility to expand the scope of the diagnostic
imaging to which the imaging accreditation could apply, but the
statute specifically excludes X-ray, ultrasound, and
fluoroscopy procedures.
MIPPA requires the Secretary to approve organizations that
then accredit advanced diagnostic imaging suppliers. By law,
the accrediting organizations must establish standards in
specified areas, including qualifications of personnel
performing advanced imaging services, qualifications of medical
directors in supervising positions, procedures to ensure that
the equipment used meets performance specifications, standards
to ensure the safety of both beneficiaries and staff performing
the imaging test, and quality assurance and control program to
ensure the reliability of the diagnostic images.
CMS selected three national accrediting organizations that
meet all the standards and requirements prescribed in MIPPA:
the American College of Radiology; the Intersocietal
Accreditation Commission; and the Joint Commission. MIPPA
provided that suppliers previously accredited by one of these
approved accreditation organizations did not need to seek new
accreditation to comply with the MIPPA requirements but must
continue to maintain their accreditation.
As of May 25 of this year, there are 15,821 accredited
suppliers and a total of 61,434 locations, two-thirds of which
are accredited by the American College of Radiology. The
accrediting organizations designated by the Secretary have
developed detailed standards that address the qualifications of
individuals performing the technical component of advanced
diagnostic imaging. Each accrediting organization has developed
specific guidelines for staff performing different advanced
diagnostic imaging modalities. For example, the ACR requires
that radiologic technologists performing a CT be certified by
the ARRT or have a State license, have documented training in
CT, and complete various continuing education requirements. The
other accrediting organizations have similar requirements or
assurances.
In States where there is a licensure or certification
requirement, the accrediting organization standards include
those State requirements. However, the accrediting
organization's personnel standards go beyond these minimum
State requirements to include a range of standards that address
different aspects of advanced diagnostic imaging. This assures
that only technicians and technologists that meet the
experience and education requirements established by the
accrediting organizations are considered qualified personnel.
CMS believes that the MIPPA accreditation provision strikes
a careful balance by focusing oversight and attention on areas
of imaging that pose the greatest risk to patients in a manner
that minimizes the burden imposed on physicians and others who
furnish imaging services. The exclusion of X-rays, fluoroscopy,
and ultrasound from accreditation requirement limits burdens on
individual physician practices, especially primary care
physicians who may perform these tests in their offices.
The use of accrediting organizations is required in MIPPA
and enhances patient safety. This approach enhances patient
safety without the need for additional direct Federal
Government oversight of every supplier of advanced diagnostic
imaging that serves Medicare beneficiaries.
As physicians increasingly rely on advanced imaging
services to diagnose complex medical conditions, the MIPPA
accreditation requirement provides Medicare beneficiaries with
assurances of imaging facilities with well-trained staff, using
safe machines and procedures to conduct diagnostic imaging
tests.
We will continue to work to fulfill our statutory
requirements to oversee the accreditation process and ensure
that accrediting organizations, suppliers, and beneficiaries
continue to have the information they need on these
requirements. Thank you and I would be happy to answer any
questions.
Mr. Pitts. The Chair thanks the gentleman.
[The prepared statement of Mr. Spiegel follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

Mr. Pitts. Dr. Gunderson, you are recognized for 5 minutes
for your summary.

STATEMENT OF LEONARD GUNDERSON

Mr. Gunderson. Chairman Pitts, Representative Pallone, and
members of this distinguished committee, good morning and thank
you for the opportunity to testify at today's hearing.
ASTRO and its over 10,000 members applaud the leadership of
Representatives Whitfield and Barrow for sponsoring the CARE
Act which has broad bipartisan support in this committee. ASTRO
strongly supports immediate passage of the CARE Act which is a
key component of our patient safety initiative.
I am an emeritus professor and consultant in radiation
oncology at Mayo Clinic where I have practiced for 28-1/2
years, 21 years in leadership positions. I am the chair of the
ASTRO board of directors who I am representing today. I care
deeply about my profession and the health and safety of our
patients.
It is important to note the marked difference in the use of
radiation for treatment of cancer patients versus for
diagnostic purposes. In diagnostic radiology, low doses of
radiation are used for imaging studies to determine if problems
exist. With radiation oncology, we use high-dose radiation to
kill cancer cells, and we often find better results with higher
doses.
When a patient is diagnosed with cancer, a radiation
oncologist discusses and agrees upon treatment options with the
patient and their family. We plan and deliver that care with
support from nonphysician members of the radiation oncology
treatment team. This treatment team consists of a medical
physicist responsible for quality assurance programs and making
sure the equipment is working properly; a dosimetrist carefully
develops a computerized plan in conjunction with the radiation
oncologist to make sure the cancer gets the prescribed dose
while nearby healthy tissues are spared; and a radiation
therapist or technologist who administers daily radiation
treatments under the physician's supervision.
ASTRO has long advocated for Congress to improve the safety
of radiation therapy by establishing minimum education and
credentialing standards. As you are aware, in some States,
basic training standards are voluntary, allowing individuals to
perform some radiation oncology procedures without any formal
education. Without a minimum level of standards, patients are
at risk.
The CARE Act would set needed education and certification
standards for radiation therapists, medical physicists, and
medical dosimetrists who participate in the delivery of
radiation therapy for Medicare patients. These minimum
standards will help ensure that patients are treated accurately
and safely, leading to reduced complications and potentially
higher patient survival rates.
We are concerned about proposals to expand MIPPA in lieu of
proceeding with the CARE Act. As you know, MIPPA applies only
to advanced diagnostic imaging services provided in
freestanding centers, not radiation therapy services. If MIPPA
were simply expanded to include radiation therapy services, we
are concerned that the vast majority of radiation oncology
patients won't benefit because they are treated in hospital
outpatient departments, not in freestanding centers.
While a critical step, we do not believe that the CARE Act
alone can prevent medical errors that are possible in a complex
treatment such as radiation therapy. That is why ASTRO is
committed to working with Congress and this committee on
additional efforts to ensure patient safety, particularly in
the area of practice accreditation, which is different than
credentialing the nonphysician members of the radiation
oncology treatment team. The CARE Act is one of the many
pathways toward increased patient safety. ASTRO has been a
leader in efforts to improve the quality of care and patient
safety and these initiatives are detailed in our written
testimony.
Finally, I want to conclude with a story of one of my
patients that immediately came to mind when I was asked to
testify. It involves a man diagnosed with metastatic terminal
cancer that was not responding to chemotherapy. His dying wish
was to walk his daughter down the aisle at her wedding. He
needed, of course, radiation therapy to treat his metastatic
cancer, relieve his pain, and hopefully prolong his life. Just
before his first radiation treatment, one of our well-trained
radiation therapists caught a computer error that if left
unchecked would have resulted in a less-than-favorable outcome.
We corrected his treatment plan and delivered a high-quality
course of treatment. Although his cancer ultimately killed him,
it was not before he achieved his wish of walking his daughter
down the aisle.
This story illustrates the importance of ensuring that
every cancer patient is treated by a team that includes top-
notch, highly trained and qualified individuals, which is why
we need to pass the CARE Act. ASTRO wants patients to have
peace of mind when it comes to safety, quality, and efficacy of
radiation therapy. We urge the committee to immediately pass
the CARE Act and we look forward to working with you on
additional policies to further enhance the quality of care
patients receive. Thank you again for the opportunity to
testify, and I would be happy to answer any questions.
Mr. Pitts. The Chair thanks the gentleman.
[The prepared statement of Mr. Gunderson follows:]
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Mr. Pitts. I now recognize Dr. Smith-Bindman for 5 minutes
for an opening statement.

STATEMENT OF REBECCA SMITH-BINDMAN

Ms. Smith-Bindman. Mr. Chairman, ranking member, and
members of the subcommittee, thank you for this opportunity to
testify today. I am Dr. Rebecca Smith-Bindman, a professor at
the University of California, San Francisco School of Medicine.
I am a clinical radiologist and I conduct research focused on
assessing the risk and benefits of medical imaging.
My testimony today focuses on CT because it is one of the
most common imaging tests that we will use for medical
diagnosis, and is also the test for the greatest potential for
causing harm because of the amount of radiation it uses. CT
uses X-rays to obtain extremely detailed images of internal
organs, and the development of CT is widely considered among
the most important advances of medicine.
In part because it is so useful, the use of CT has
increased dramatically over the last 15 years. Last year
approximately 75 million CT scans were obtained and
approximately 1 person in the U.S. per 10 obtained a CT.
Although CT is useful it delivers much higher doses of
radiation than do conventional X-rays, and exposure to
radiation can cause cancer.
To help put this into context, when you go to the dentist
and you are offered dental X-rays, you may pause to consider
the benefits as well as potential harms associated with getting
X-rays. The most common type of CT scan that patients undergo
in the U.S. delivers the same amount of radiation as
approximately 1,500 or more dental X-rays.
In other contexts, people have been concerned about the X-
rays that are used at airports to screen passengers. One CT
delivers the same amount of radiation as approximately 200,000
airport screenings.
My research team at UCSF has conducted several research
studies to assess the radiation dose patients receive when they
undergo CT and we have found that for every type of CT scan
patients undergo, the radiation doses are higher than most
physicians are aware, and we have found tremendous variation in
the doses between patients in the same facility. For example,
one patient may receive a dose of radiation 20 times another,
even at the same hospital and for exactly the same clinical
problem. Put another way, if a patient goes to a facility to
get a CT scan of her abdomen, she has no idea if she will
receive a low dose or a high dose. And yet the patient who
receives the higher dose study may be at risk 20 times-fold of
getting cancer for that examination while receiving no extra
benefit from the radiation dose to which she was exposed.
These differences in how much radiation are used for
diagnostic CT is not accidental and yet these are not
considered errors, but instead, I believe incorrectly, these
are considered and labeled the ``art of medicine.'' This sadly
is more akin to Russian roulette than personalized health care.
There are clear-cut cases of errors in the use of CT when
the technologist delivers a dose vastly higher than intended.
And when these kinds of errors are made, patients from
diagnostic CT can be exposed to doses that cause skin burns,
hair loss, and severe damage to the tissue. Thousands of such
cases have been reported and many of these errors have happened
because of errors in how the technologist programmed the
scanner. However, even when CT scanning is done correctly,
patients who undergo CT--even a single CT--have an increased
risk of cancer; and the higher dose of radiation to which they
are exposed, the greater their risk. Since many patients who
undergo CT undergo multiple scans, their risks are even higher.
An important research paper was published yesterday in the
Medical Journal of Atlanta, and that study directly showed that
healthy children who were exposed to even a single CT were more
likely to develop brain cancer and leukemia. Thus, doses we
experience every day as part of routine CT are potentially
dangerous.
My research team has studied millions of individuals
enrolled in large integrative health-care systems and we have
found a large number of patients receive unnecessarily high
doses of radiation because of repeated scanning with CT and
because some CTs deliver higher doses than needed. Several
people are involved when a CT scan is done. Radiologists order
the scan and they select the protocol or set of instructions
that should be used, but it is the technologist who does the
study.
The console of a modern CT scanner looks a lot like the
control panel of a fighter plane, and it is not possible for
the technologist to simply press a ``low dose'' button and
generate the desired image. Instead, the technologist must make
a large number of independent decisions and follow complex
instructions on how to program each patient. Yet despite the
complexity of the machines and the profound importance of what
the technologist does, the technologist who conducts CT
examinations receives little education on what doses are
excessive, receive no consistent education on how to lower
doses they deliver, and there are no consistent standards. In
some States technologists receive only minimal on-the-job
training.
Further, because there are no uniform design standards,
technologists have to scan patients on different machines that
all work differently. As part of the research project I am
leading to standardize dose, we have organized a large meeting
that will be available to all, to be held in February of next
year. While the meeting will target physicians, physicists,
administrators, referring physicians, the primary focus is to
educate and certify radiology technologists on how to
understand and monitor and lower the doses to which they are
exposed.
There is a second and equally important problem that must
be addressed, however, to improve the safety of CT.
Radiologists determine how the test should be performed but
there are few guidelines on what target doses are desirable.
Each radiologist starts from scratch in creating these
protocols at their institution. And while the general principle
is that doses should be kept as low as reasonably achievable,
there are few guidelines about what doses are reasonable or
achievable.
In order to improve the safety of CT, we need clear
standards for what are acceptable levels of radiation for
diagnostic CT. The doses used in clinical practice must be
monitored. The National Quality Forum, a leading organization
that develops and endorses measures of health-care quality, has
endorsed the measure to focus on CT. And if facilities follow
this measure, they will quickly learn what they are doing and
where they need to improve.
Lastly, the dose should be reported in every patient's
medical record. California recently enacted a law that goes
into effect in several months that requires this and provides a
template for national legislation. There are a growing number
of data monitoring software products that help facilities
conduct the kind of dose assessment and monitoring that I have
suggested, and ideally these dose-monitoring software products
can be used and can be integrated with manufacturers and
radiology information systems to help us work together to
enable the electronic capture of patient dose information and
inclusion of the information in the medical record.
Lastly, oversight of CT is highly fragmented. The FDA
oversees the approval of the CT scans but does not have
regulatory oversight for how these machines are used in
practice. Through MIPPA, CMS has an accreditation process in
place that we heard about. Separately CMS' other authorities to
encourage the adoption of quality standards, such as those
adopted by the National Quality Forum that could facilitate
facility assessment, reporting, standardization of the
radiation dose used for CT, and CMS should be incorporated to
incorporate such quality measures in their systems.
Mr. Pitts. Could you wrap up?
Dr. Smith-Bindman. Given the importance of CT and yet its
potential for causing cancer, it is imperative we make CT
scanning as safe as possible. These efforts must include
education, certification of technologists, the creation of
benchmarks, the requirement of recording and monitoring data,
as well as a reduction in the necessary exams.
Thank you for allowing me to participate in this
discussion.
Mr. Pitts. Thank you.
[The prepared statement of Ms. Smith-Bindman follows:]
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Mr. Pitts. Dr. Martino, you are recognized for 5 minutes
for your summary.

STATEMENT OF SAL MARTINO

Mr. Martino. Chairman Pitts and members of the
subcommittee, my name is Sal Martino and I am the chief
executive officer of the American Society of Radiologic
Technologists. I am also a registered radiologic technologist
myself. On behalf of ASRT's 146,000 members, thank you for
calling this hearing to examine why we must establish standards
for medical imaging and radiation therapy technologists.
These individuals perform procedures that are critical to
accurately diagnosing and treating millions of Americans each
year, from the X-ray that monitors the lungs of a premature
infant to the radiation therapy that extends the life of a
grandmother fighting cancer. Because these procedures expose
patients to powerful doses of radiation, most of us assume that
everyone who performs them is competent and educated. But the
truth is, unqualified personnel examine and treat thousands of
patients every day. That is because Washington, DC, and 11
States do not regulate radiographers, 15 States do not regulate
radiation therapists, and 20 States do not regulate nuclear
medicine technologists.
In States without regulations, people are allowed to expose
patients to potentially dangerous levels of radiation after
just a few weeks of on-the-job training. And even in States
where personnel are regulated, laws vary widely.
Unqualified personnel represent a serious health risk to
the American public. Fortunately, a solution is within reach.
The Consistency, Accuracy, Responsibility, and Excellence in
Medical Imaging and Radiation Therapy bill, known as the CARE
bill, asks the Federal Government to establish standards for
technical personnel in the radiologic sciences.
Under the CARE bill, anyone who performs medical imaging or
delivers radiation therapy would be required to graduate from a
formal educational program in the field. They also would have
to pass a national certification exam that tests their
understanding of radiation protection and patient care
techniques. And finally, they would be required to obtain
continuing education throughout their careers, ensuring that
they remain proficient.
Many of you are familiar with the CARE bill. It was first
introduced in the 106th session of Congress in 2000 and it has
been introduced in every session since then. In 2006, the
Senate passed the bill by unanimous consent, but the session
ended before the House could take action.
The current version of the CARE bill, H.R. 2104, has more
than 120 bipartisan cosponsors in the House of Representatives.
It also has the support of dozens of health-care and patient
advocacy organizations that represent millions of Americans.
Together we support the CARE bill for three important
reasons: First, the CARE bill will improve quality. The
accuracy of any radiologic procedure depends on the skill of
the person performing it. An X-ray won't reveal a broken bone
and a CT won't find a growing tumor if the person using the
equipment doesn't know the basics of anatomy, exposure, and
technique. Accurate exams lead to diagnosis, treatment, and
cure. Poor-quality exams lead to additional testing, delays in
treatment, and unnecessary anxiety for patients. Even worse,
they may cause a misdiagnosis that has tragic consequences.
Radiologic technologists must be properly educated to perform
their work accurately.
Second, the CARE bill will improve safety. Medical
radiation comes with risks. Overexposure can cause skin burns,
lead to the development of cancer, and cause birth defects in
future generations. CT scanners, gamma cameras, and linear
accelerators are some of the most complex technology in the
medical field, and patients could be injured or even killed if
this equipment is not used properly. Educated technologists
know how to properly administer radiation, position patients,
and shield organs to deliver the lowest possible dose.
And third, the CARE bill will reduce health-care costs.
More than 300 million medical imaging procedures are performed
in the United States every year. Unfortunately, thousands of
these exams have to be repeated every day because unqualified
personnel made positioning or exposure errors. The Federal
Government pays for many of those mistakes. Medicare spent
approximately $11.8 billion on medical imaging in 2009. If we
can reduce the number of repeated exams by just 1 percent,
Medicare would save more than $100 million a year.
In an era when difficult budget decisions must be made, the
CARE bill makes good fiscal sense. The best way to ensure the
quality, improve the safety, and reduce the cost of radiologic
procedures is to establish standards for personnel who perform
them. For the past 12 years, that has been the straightforward
goal of the CARE bill. It is time to pass this important piece
of legislation. Your support for the CARE bill shows your
support for America's patients. Thank you.
[The prepared statement of Mr. Martino follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

Mr. Pitts. The Chair thanks the gentleman and thanks all
the panel for your testimony. We will now begin questioning.
The Chair recognizes himself for 5 minutes for that purpose.
Mr. Spiegel, we will begin with you. Can you tell us why
MIPPA does not include imaging services that are done in the
hospital setting? It seems to me that patients in the hospital
would be at the same risk of harm as any other patient if these
services are performed by personnel that are not adequately
trained.
Mr. Spiegel. I wasn't employed at CMS at the time the bill
was enacted, but the provisions of the statute don't address
advanced diagnostic imaging in a hospital setting. We
implemented the provisions that were enacted in the MIPPA
statute.
Mr. Pitts. Would it be appropriate to address this issue by
an expansion of MIPPA?
Mr. Spiegel. I am really not in a position to say whether
or not hospital radiology needs to be addressed apart from
MIPPA or some other way. I know CMS has in place hospital
conditions or participation that address requirements for
imaging in a hospital setting and we enforce them.
Mr. Pitts. Dr. Smith-Bindman, an individual patient in
discussion with their doctor may be willing to be exposed to
increased risk for radiation exposure in order to diagnose or
treat their cancer. Do you think that if we err on the side of
overregulation by, for example, instituting rigid guidelines
that we run the risk of inhibiting patients' care and possibly
exposing providers of these services to liability?
Ms. Smith-Bindman. I think that you mentioned two things. I
think, first, we need to have those discussions between
patients and providers that acknowledge there are risks and
benefits of medical imaging. So first those discussions have to
happen.
Second, if we can encourage facilities to start to look at
the doses that they use, they can lower those doses, literally
overnight. And so part of what I am encouraging is both looking
at doses and then not imposing rigid standards on how to lower,
them but just requiring facilities look at how they are doing.
And just looking at how they are doing, I have had experience
at a large number of facilities, has led to an overnight
reduction in doses for patients who get very high doses.
Mr. Pitts. Dr. Martino, or any of you, what question should
patients ask the technologist or the radiologist before getting
an imaging exam? And what questions should they ask the
referring physician before going forward with an exam?
Mr. Martino. Well, the first question they would ask--and
if I took my granddaughter in for an X-ray, the first question
I would ask is, are you a certified radiologic technologist?
And if they were not, I would not let them take my X-ray or
that of my granddaughter. So that is the number one fundamental
question for me.
Ms. Smith-Bindman. I think going back a step, anytime
advanced imaging is ordered, a patient should ask their
physician if it is absolutely necessary. Do I need this test?
Do I need this test now? Or can I wait to have this test? Can I
have another test that may help? Or if I do need this test, is
it possible to have a test that does not use ionizing
radiation?
And now we are so enamored with testing that often patients
begin that discussion wanting the test, without appreciating
that there are choices to be made and that there are both risks
and benefits.
So first I decide, do I actually need to go forward? And
then if they go forward, I think the more patients that ask
their physicians and their technologist, can you tell me what
kind of radiation dose I am going to be getting from this test
will really encourage the technologists and providers to look
at their own data so they can provide really informed
information.
Mr. Pitts. Thank you. Dr. Gunderson, could you tell us why
this is an issue that needs legislation rather than something
that could come from within the medical societies or State
level boards?
Dr. Gunderson. Radiation oncology societies can certainly
make recommendations to individuals as far as whether
certification should exist. And we certainly do do this. But
that does not require our members to listen to what we say and
to carry it out.
So I think there is an absolute need to have the CARE Act
passed so that it does put in place minimum standards. I think
of this as a foundation for building further with regard to
safety issues as putting in place the minimum standards that
are required by the CARE Act which societies can encourage but
certainly cannot enforce in any way.
Mr. Pitts. I just have 10 seconds. Dr. Martino, is there
any benefit to State flexibility with regard to technician
licensing? I assume that the availability of accredited schools
varies. Might States with many health professional shortage
areas lose out if unlicensed technicians can no longer
practice?
Mr. Martino. No. There are more than adequate radiologic
technology programs throughout the country. Even in rural
areas. And the CARE bill also does have provisions to phase in
and allow those individuals to get the additional education
that they would need to become certified.
Mr. Pitts. My time has expired. The Chair recognizes the
ranking member for 5 minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman. I was going to start
with Dr. Gunderson.
In your testimony you describe differences between
diagnostic imaging and radiation therapy. And I wondered if you
would elaborate on those differences and tell us more about the
varying safety considerations and how might the education and
training of radiation therapists differ.
Dr. Gunderson. With regard to the marked differences
between diagnostic radiology and radiation oncology, as I
mentioned, diagnostic radiology uses much lower doses of
radiation, primarily for imaging purposes to determine if
problems exist, and they are exceedingly helpful to a radiation
oncologist with CT imaging or an MRI to say, here is where the
cancer is and here is where we need to focus upon.
In radiation oncology we use much higher dose levels of the
radiation, but dose alone is not the thing that one needs to
think about. We use much higher doses, where if we are treating
with radiation alone, we are going to be delivering often a
series of 30 to 40 treatments over a time period of 7 to 8
weeks, treating 5 days a week. And dose alone is--total dose
becomes important, what the dose per fraction is, and whether
we are using it with curative intent or intent to try to
totally kill the cancer versus with palliative intent.
What are we doing with regard to patient safety issues? We
are very delighted with the provisions that were put into the
Patient Safety Act in the mid-2000s with regard to the ability
to collect information on medical errors or near misses without
there being legal ramifications. We have, in fact, begun a
process of contracting with an existing patient safety
organization to launch the first radiation oncology error
reporting system.
As I noted, we believe the confidentiality provisions
provided by the Patient Safety Act are going to ensure that
accurate data is submitted and will also mean better
participation from radiation oncologists throughout the United
States. We think that contracting with a PSO will allow us to
meet our goal of collecting radiation oncology patient safety
data, analyzing it to improve the safety of radiation oncology,
being able to do root-cause analyses, and pass that information
along to our membership in appropriate ways so that they can
learn from it and apply those things in their own practices.
And we expect the patient safety organization to be functioning
by the end of 2012.
Also in our written testimony we talked about things that
we have done starting--and expanding on in 2010. Patient safety
has always been an important issue in radiation oncology. But
with the 2010 incidents, we did a 360 look. We put forward the
``Target Safely'' plan which is discussed in some detail in
pages 6 to 8 of the written testimony with regard to working
with industry to have standardization of talking across
different systems from different providers. We call it the IHE-
RO program where if we buy one thing from one provider of
equipment versus another, that they will talk to one another
and that there won't be errors in that. We are interested in
practice accreditation. We have written a series of white
papers.
So there are a number of things that we are doing that are
outlined in there. And we feel strongly and we will continue to
discuss these with our members and to work carefully with this
committee and Congress in trying to improve patient safety.
Mr. Pallone. Well, thank you, Doctor. I appreciate that.
I wanted to ask Dr. Smith-Bindman, you testified that
credentialing of the personnel who position patients and
administer radiation consistent with the goals of the CARE Act
is an essential first step in improving the safety and quality
of CARE. That is correct?
Ms. Smith-Bindman. Yes.
Mr. Pallone. OK. You also mentioned the importance of other
strategies to improve safety and quality, such as the
development and adoption of additional clinical guidelines,
capture of info on the doses that patients receive, and
documentation of dose information in the patient's medical
records.
I want to focus on the tracking and documenting of the
radiation dose a patient receives and the quality measure you
mentioned. Can you explain why you believe that the adoption of
the National Quality Forum-endorsed CT quality measures in
clinical practice or one with similar goals would improve the
safety and quality of CARE?
Ms. Smith-Bindman. I think radiologists really want to do
the best job that they can. And most radiologists understand
that that means lowering the doses, keep them within a very
narrow range. But unfortunately, most radiologists currently
have no idea of the doses to which their patients are exposed.
So if a patient goes to a facility and says, Doctor, can you
tell me how much radiation I got on that exam or how much am I
likely to get, or what kind of doses do you usually give your
patients who undergo abdominal--an abdominal CT, most
physicians and most facilities would have no way to answer that
question.
So by adopting the quality measure, facilities are asked to
summarize the doses they are using. What is the average dose
for an abdominal CT? And that would quickly allow facilities to
see how they are doing.
And as I mentioned, I have worked with a large number of
facilities. And for each of those, the first step of us showing
them their data has been surprise that the doses have been so
high. And the second step has been to figure out how to lower
them. And it is not so difficult to lower them once you figure
out the problem. So if patients in general are being imaged for
a larger area, well, then you image a smaller area. If patients
undergo four scans of their chest and that leads to higher
doses, well maybe you want to reduce that to one. So I think it
is a way to just allow facilities to see how they are doing, to
start having standard metrics so all facilities start using the
same words to describe dose and use the same standards against
which they are assessing their quality and performance.
Mr. Pallone. Thanks a lot. Thank you, Mr. Chairman.
Mr. Pitts. The Chair thanks the gentleman.
We are in a series of votes that are going to last past the
noon hour. We will take one more line of questioning from the
vice chairman, Dr. Burgess, for 5 minutes before we break.
Mr. Burgess. My question is: Why do we have so many votes
that are going to take us past the noon hour, Mr. Chairman? Who
thought that was a good idea?
Well, Dr. Spiegel, I just have to tell you, you struck a
chord with me with your discussion, perhaps not entirely in the
confines of what we are considering on the committee today. But
I practiced OB/GYN for 25 years back in Texas and I recognize
that, just like you, you recommend the test or a procedure to a
patient, and the next question is generally not is it safe, is
it necessary? We wouldn't even get down to the detail of how
much radiation to which I would be exposed. But it is, Does my
insurance cover it? And if my insurance covers it, suddenly the
curiosity drops right off.
And perhaps one of the failings of the third-party payment
system that we have developed and why I believe so much in a
consumer-directed health care and health savings account is
that you have to get the patient back into this equation. And
the money is one way to do it. And as a consequence of the
patient being in charge of the money, perhaps even the
questions about the radiation safety or the dosage might be
something that is introduced back into the conversation.
So I appreciate very much your observation on that. And I
will just tell you, I am sure it is happening hundreds of times
this very morning, where a radiological procedure is being
recommended. And the patient is anesthetized and the doctor
also may be anesthetized as well, except in our specialty, in
OB/GYN, when a pregnant woman inadvertently gets an IVP, then
suddenly everybody is concerned about what the dose of
radiation was that was involved in that study. And then we go
into great detail to try to figure it out.
Do you have any other observations on that? Because that
was a particularly powerful statement that you made.
Ms. Smith-Bindman. I mean, in addition to being an
academic, I am a parent who has three children. And I have been
in many circumstances where imaging with radiation is advised
to my children. And in those circumstances, I want to know the
risks and benefits to my child of that exam. And I try very
hard to go in not as a radiologist but to go in as a mom. When
my youngest fell out of a tree and had a CT scan, that seemed
like the right thing to do. He did a head-dive out of a cherry
tree.
Mr. Burgess. That was your son, correct? Not your daughter?
Ms. Smith-Bindman. That was my son. Only the CTs of the
head are my son's.
But last year, he had a very small fall, skiing; and I
couldn't get ahold of my husband and I took him to the
emergency department. And the emergency department physician
told me later that from across the room he could see that my
son had a concussion, but knew for sure he didn't have a bleed.
And I went in very open. If he needs a CT, he needs it. If not,
I am not going to influence his decision. And the ED doctor
said, if you want a CT, I am happy to do it, but I don't think
he needs it. So I was very happy with that decision.
And partly what I do when I educate technologists and
radiologists is to think of every patient as if it is your own
family member and use all the information to decide whether it
is necessary: the value of the test, the effectiveness, the
risks. And then I agree with you, I think the payment piece has
disappeared from our consideration, but it is a very important
issue.
DMr. Burgess. Thank you.
Dr. Martino, I need to ask you--again, this is a bit off
topic, too. But the dosage of radiation that we get when we
walk through that TSA scanner at the airport, is that a
significant source of radiation for people?
Mr. Martino. All radiation is not good, but we have it in
the environment and wherever. I believe that those are low
enough that I don't worry about that.
Mr. Burgess. Bear in mind that you are talking to a panel
of frequent flyers here. Anyone who lives west of the
Mississippi is probably higher on the dosage chart.
Mr. Martino. Myself also. But it is so low down compared to
what medical radiation is in terms of the individuals that are
giving those doses to patients.
Mr. Burgess. Well, I will tell you why I was concerned
about this. Several years ago in the transportation bill, I
tried to get language in addressing the radiation exposure to
flight crews. You know, the solar activity varies from time to
time. And this is information that is available but not
generally dispensed to the airlines, such that they might
select a different flight route or altitude because of solar
activity and solar radiation that might be emanating that day.
So you are right. We have got it in our environment all the
time. And as a consequence, any is possibly dangerous, so why
wouldn't we do the things necessary to minimize that? I was a
little taken aback when we developed these back-scatter imaging
devices, you know, to catch the bad folks. But at the same time
you are putting a lot of innocents through this device. And for
those of us up on the dais here, that is twice a week, 35 weeks
a year.
Mr. Martino. Myself included. I would add though, I think
anyone who has anything to do with any kind of equipment that
dispenses radiation, even the low doses, say, in an airport
scanner, should have some kind of minimum knowledge and
understanding about what it is they are operating. And if there
was an error--I mean, it could be a simple hour course for the
TSA scanners, that they understand.
Mr. Burgess. Are they certified in any way as far as
radiation understanding?
Mr. Martino. No, not that I am aware of.
Mr. Burgess. Did the FDA get involved in this? Because they
can be pretty tough on medical devices.
Mr. Martino. I deal with the certification of those
individuals that are dispensing radiation for medical purposes.
Mr. Burgess. Thank you, Chairman. I will yield back. Thank
you.
Mr. Pitts. The Chair thanks the gentleman. We are in the
middle of a series of votes. There are about 5 minutes left on
the first vote. We will recess until about 5 minutes after the
last vote, which will be around 12:15, I am told. So we ask for
your patience. At this time, the subcommittee stands in recess.
[Recess.]
Mr. Pitts. The time for recess having expired, we will
reconvene, and we have finished the first round of questioning.
We will go to follow-up with Dr. Burgess for 5 minutes for
questions.
Mr. Burgess. Thank you, Mr. Chairman. Dr. Gunderson and Dr.
Martino, if I could ask you, do you think if we put in place a
Federal minimum standard for accreditation for technologists
that it will restrict entry into that field and we are going to
end up with difficulty filling those positions?
Dr. Gunderson, if you will go first, and Dr. Martino.
Mr. Gunderson. At the present time, the main issue I think
with certification programs and training programs for radiation
therapy technologists is the fact that we may not currently
have enough training programs that exist out in the real world,
and part of that is because some of the programs have
contracted instead of expanded.
And when I moved from Mayo Clinic in Rochester, Minnesota,
down to Mayo Clinic in Arizona, we were surprised to find that
there were no training programs for radiation therapists in
Arizona, and so we actually worked together with the radiation
oncology practices in Arizona and with the community college
and actually set up a program which actually required the
institutions putting in some financial support because the
community college wasn't willing to take that on themselves
upfront. And so we felt strongly enough about the need for a
training program with radiation oncology technologists that we
convinced our colleagues in what ended up being competing
institutions to say the need exists, let's work together and
make sure this happens. And that program has stayed as a
continuous program ever since that time, so that will be one of
the issues, just making sure there are----
Mr. Burgess. Just to be sure, did those programs result in
certification of those students who completed the requirements?
Mr. Gunderson. They did. They would have progressed through
the training and gone to certification. But it is an issue, and
that is why once the CARE Act is passed, we will have to be
careful to phase in some of these things so that if there
aren't programs that exist in certain States, that one has time
to put those programs into place and allow them to function. In
my mind it will not prevent people from going into the field,
because it is a very attractive field, and we have not had any
problem at all filling the positions in the school that we
created in Arizona, for example.
Mr. Burgess. Very well. Dr. Martino, you may have actually
answered that before we went to break, but your thoughts on
that?
Mr. Martino. ASRT has a significant research department,
and we do a lot of research and publish research. Every year we
do an enrollment survey to see what the enrollment in the
educational programs are throughout the country, both in
medical imaging and radiation therapy. Right now, in fact,
there is a bit of an oversupply of medical imaging
technologists, and students have waiting lists in most
community colleges and are----
Mr. Burgess. If I could interrupt you for just a minute.
What about the geographic distribution, though; are there areas
in the country where it would be more of a challenge to fill
those positions?
Mr. Martino. Not right now. Yes, of course, you have, you
know, more programs in some of the urban areas, but even in the
rural and suburban areas, community colleges are very
interested in these kinds of programs because they lead to
employment when students get out of school. They have also now
raised the requirements; starting in 2016, you are going to
need an associate's degree to enter the field. So many
community college programs are now opening. So we don't really
expect there to be that much of a shortage in radiography.
Radiation therapy, right now there is only a 4-1/2 percent
vacancy rate in radiation therapist positions. Dr. Gunderson is
right, it is somewhat regional. There are a couple of States
that don't have radiation therapy programs, but there are a
couple of radiation therapy programs coming online. But our--
both our workplace surveys and our enrollment surveys show that
there is more than enough of supply right now to meet demand
and that many of the programs, like nursing programs, have
waiting lists to get in because students are realizing that
they want to go to college and get a job when they get out, and
health care is a really expanding area. And in any places where
there might be a problem, there is a phase-in period for the
CARE bill, so there should be enough time for supply to meet
demand.
Mr. Burgess. Very well. You know, remembering the passage
of MIPPA in the summer of 2008, it was July of 2008, and we
have had another hearing in this committee on this issue back
in 2010, and I think Chairman Pallone led that hearing, and we
are very grateful to him for doing that, but I am hard pressed
to recall a hearing on this subject prior to the passage of
MIPPA.
I have only been on the committee since 2004, so staff may
correct me that there have in fact been other hearings, but it
is a fairly significant and fairly complex issue, and when
MIPPA passed, for those of you familiar with the Doc Fix, this
was the passage of the Doc Fix. It came up on suspension rather
rapidly one summer morning, and nobody ever wants to vote
against the Doc Fix, myself included, because the docs always
get mad if you do.
But there were all these other ancillary policies that were
then cobbled together and thrown on this so-called MIPPA bill,
and I think it is just a cautionary tale for us here on this
side of the hearing room that we must be careful when we take
these things on, because they do have far-reaching, real-world
consequences that affect people in very profound ways, both
positively and negatively. And I wish we had taken the time to
study this issue a little bit more before the leadership at
that time put it onto that bill that came up rather hastily on
the House floor in order to make a political statement and
cause a stir in the then-Presidential campaign in 2008.
Mr. Chairman, thank you for the indulgence, and I will
yield back.
Mr. Pitts. The Chair thanks the gentleman. For follow-up
for 5 minutes, the ranking member, Mr. Pallone.
Mr. Pallone. Thank you. I just have a brief question
because I didn't get to ask it before of Dr. Gunderson. It was
clear from your testimony that you believe credentialing for
technologists will do a great deal to improve patient safety.
But can you elaborate on why ASTRO believes that additional
patient quality and safety activities are an important
complement to the goals of the CARE Act?
Mr. Gunderson. Rephrase your question?
Mr. Pallone. Sure. You said that you believe--or at least I
thought from your testimony--you believe that credentialing for
technologists would do a lot to improve patient safety. So I
just wanted you to tell me why you believe that, you know, that
that is true, why additional quality and safety activities are
important to the goal of, you know, the CARE Act, which is the
bill that----
Mr. Gunderson. We believe it is important for the three
components of the treatment team beyond the physician--the
medical physicist, the medical dosimetrist, as well as the
therapist/technologist. And if you think of a machine with
gears that mesh together, if we have two members of that
treatment team that have education and training but the third
person doesn't, then things can fall out of phase and things
won't work as smoothly as they need to work.
So while the plans that we put in place for radiation
therapy are a combination of interactions between the radiation
oncologist and the dosimetrist where the radiation oncologist
uses a CAT scan or MRA to see here is where the cancer is, here
is where the lymph node areas are that are at risk, and we
contour that, and we also help contour the normal tissues and
the healthy tissues that we want to spare. That information
then is put into place by hopefully a trained dosimetrist who
can integrate that and say, ``OK, I am going to put my
radiation beams in through all of these angles and put them in
place so we can encompass the tumor and protect the normal
tissues.''
That information is then passed on to the therapist on the
treatment machine, and as Representative Burgess I think talked
about previously, if you have somebody that doesn't have the
training to make sure that the machine is turned on properly,
to make sure the patient is positioned properly, then all of
the work done by the radiation oncologist and dosimetrist comes
to naught. So this is why we feel there needs to be minimum
standards for all components.
The physicist is the one that supervises the whole--if you
want to call it--the safety team beyond the M.D. To make sure
everything is running properly, and so he is at the top of that
safety chain from the treatment team perspective along with the
radiation oncologist. But if the dosimetrist and therapist
don't understand what they are doing, then what we envision
happening with our--with the safety and care of our patients
isn't going to come to pass. And that is why we support the
CARE Act for all three components, the physicist, the
dosimetrist, and the therapist having adequate training and
adequate certification, and why we strongly support the CARE
Act.
Mr. Pallone. All right, thanks a lot, and thank you, Mr.
Chairman.
Mr. Pitts. The Chair thanks the gentleman. I will remind
all members of the subcommittee who were unable to attend or
return to the hearing that they may submit their questions in
writing. They have 10 business days to submit questions for the
record.
I ask the witnesses to respond to their questions promptly,
and I would like to thank the excellent panel we had today for
the information they have shared with us. Members should, by
the way, submit their questions by the close of business on
Friday, June 22nd. Without objection, the subcommittee is
adjourned.
[Whereupon, at 12:30 p.m., the subcommittee was adjourned.]