[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]



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                              __________



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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

                              ----------                              
                                                                   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

                              ----------                              


                          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.]

                                 
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