[Congressional Record Volume 149, Number 82 (Thursday, June 5, 2003)]
[Senate]
[Pages S7489-S7491]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ENZI (for himself, Mr. Kennedy, Mr. Daschle, Mr. 
        Lautenberg, and Mr. Dorgan):
  S. 1197. A bill to amend the Public Health Service Act to ensure the 
safety and accuracy of medical imaging examinations and radiation 
therapy treatments; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. ENZI. Mr. President, imagine for a moment you have gone to the 
doctor to have a medical condition evaluated. Uncertain as to what your 
injury may be, your doctor sends you to a specialist for a medical 
imaging examination to determine the extent of your injury and the 
proper course of treatment for it.
  Or, imagine, having heard the dreaded diagnosis of cancer, going to 
the same facility for radiation therapy.
  In either case, our sense of concern and anxiety about our medical 
condition will serve to focus our attention on ourselves, and not on 
the caregivers providing us with the treatment we need to recover, or 
in the case of cancer, to survive.
  But, what would you say if you knew that the individual helping to 
direct your diagnosis or the one providing your course of treatment is 
someone who has done nothing more to earn his credentials than spend a 
few weeks getting some on the job training.
  Imagine how you would feel and the level of trust you would have in a 
system that allowed such a thing to happen.
  Unfortunately, that's an all too common occurrence with the present 
state of our health care system.
  But, it is a problem that we can solve with the passage of 
legislation I am introducing today.
  The Consumer Assurance of Radiological Excellence, RadCARE, Act will 
ensure that there are coherent standards in place for those who plan 
and deliver radiation therapy treatments. I am pleased to be joined by 
my distinguished colleague from Massachusetts, Senator Kennedy, as well 
as Senators Daschle, Lautenberg, and Dorgan, in this effort, which will 
bring peace of mind and restore the confidence of the health consumer 
in the treatment they receive from those who perform radiologic 
procedures. It will also increase awareness of the skills of these 
health care professionals and raise the level of visibility their 
profession enjoys in the public eye.
  It is important that we establish standards for personnel who perform 
radiologic procedures because physicians depend upon medical imaging 
examinations to diagnose disease and identify and treat injuries of all 
kinds. The quality of a radiologic procedure hinges upon the expertise 
of the professionals who assist in administering them.
  Currently, 15 States as well as the District of Columbia do not 
regulate or register radiologic personnel.
  To address that lack of attention, the RadCARE Act will strengthen 
the Consumer-Patient Radiation Health and Safety Act of 1981. The 
current law calls for States to establish voluntarily a set of 
educational and credentialing standards for radiologic and medical 
imaging personnel. Yet many States still do not have licensing laws in 
place that meet the standards recommended by the Federal Government. 
The RadCARE Act will require that radiologic and medical imaging 
personnel meet a minimum credentialing standard.
  The RadCARE Act will not affect states that have a suitable licensing 
system or those that have mandated higher standards than required by 
Federal law. If a state has no meaningful

[[Page S7490]]

regulations or licensing system, however, then the Federal standards 
will apply. The RadCARE Act also has a provision to ensure access to 
quality healthcare in rural regions where a one-size-fits all approach 
may not be applicable. Enforcement of the RadCARE Act would be achieved 
by restricting Medicare and Medicaid reimbursement to facilities that 
employ personnel who meet the minimal federal standards.
  The RedCARE Act will improve the safety of radiological procedures by 
reducing the risk of harmful overexposure to radiation. Healthcare 
costs will also be lowered by decreasing the number of repeated 
procedures due to personnel error. Additionally, the RadCARE Act will 
enable radiologists and other healthcare professionals to have access 
to quality information so that patients receive the best health care 
possible.
  This legislation is supported by a variety of organizations concerned 
with the quality of these procedures, including the American Society of 
Radiologic Technologists, the Society of Nuclear Medicine Technologist 
Section, the American Association of Medical Dosimetrists, the Nuclear 
Medicine Technology Certification Board, the Association of Vascular 
and Interventional Radiographers, and the other members of the Alliance 
for Quality Medical Imaging and Radiation Therapy, which represents the 
more than 275,000 medical imaging and radiation therapy professionals 
in the United States.
  When it comes right down to it, it's a big enough battle to fight the 
cancers or the injuries to our bodies that require such invasive 
treatments or diagnosis. We shouldn't have to worry about the level of 
competence of those who are providing us with the services we so 
desperately require for the maintenance of our health.
  I urge my colleagues to join me in supporting and passing this much 
needed legislation. It respects the power of the states who have 
addressed this problem as it provides minimum standards for those who 
have not.
  More importantly, its enactment into law will do a great deal to 
increase the level of confidence of the American health consumer in our 
healthcare system.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1197

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Consumer Assurance of 
     Radiologic Excellence Act of 2003''.

     SEC. 2. FINDINGS AND PURPOSES.

       (a) Findings.--Congress makes the following findings:
       (1) More than 300,000,000 medical imaging examinations and 
     radiation therapy treatments are administered annually in the 
     United States.
       (2) Seven out of every 10 Americans undergo a medical 
     imaging examination or radiation therapy treatment every year 
     in the United States.
       (3) The administration of medical imaging examinations and 
     radiation therapy treatments and the effect on individuals of 
     such procedures have a substantial and direct effect upon 
     public health and safety and upon interstate commerce.
       (4) It is in the interest of public health and safety to 
     minimize unnecessary or inappropriate exposure to radiation 
     due to the performance of medical imaging and radiation 
     therapy procedures by personnel lacking appropriate education 
     and credentials.
       (5) It is in the interest of public health and safety to 
     have a continuing supply of adequately educated persons and 
     appropriate accreditation and certification programs 
     administered by State governments.
       (6) Persons who perform or plan medical imaging or 
     radiation therapy, including those employed at Federal 
     facilities or reimbursed by Federal health programs, should 
     be required to demonstrate competence by reason of education, 
     training, and experience.
       (7) The protection of public health and safety from 
     unnecessary or inappropriate medical imaging and radiation 
     therapy procedures and the assurance of efficacious 
     procedures are the responsibilities of both the State and the 
     Federal Governments.
       (8) Facilities that conduct medical imaging or radiation 
     therapy engage in and affect interstate commerce. Patients 
     travel regularly across State lines to receive medical 
     imaging services or radiation therapy. Facilities that 
     conduct medical imaging or radiation therapy engage 
     technicians, physicians, and other staff in an interstate 
     market, and purchase medical and other supplies in an 
     interstate market.
       (9) In 1981, Congress enacted the Consumer-Patient 
     Radiation Health and Safety Act of 1981 (Public Law 97-35) 
     which established minimum Federal standards for the 
     accreditation of education programs for persons who perform 
     or plan medical imaging examinations and radiation therapy 
     treatments and for the certification of such persons. The Act 
     also provided the States with a model State law for the 
     licensing of such persons.
       (10) Twenty-two years after the enactment of the Consumer-
     Patient Radiation Health and Safety Act of 1981--
       (A) 13 States do not require licensure of any kind for 
     persons who perform or plan medical imaging examinations and 
     radiation therapy treatments;
       (B) 37 States license, regulate, or register radiographers;
       (C) 28 States license radiation therapists;
       (D) 22 States license nuclear medicine technologists;
       (E) 8 States license or require board certification of 
     medical physicists; and
       (F) no States regulate or license medical dosimetrists.
       (b) Purposes.--The purposes of this Act are--
       (1) to ensure the accreditation of education programs for, 
     and the licensure or certification of, persons who perform, 
     plan, evaluate, or verify patient dose for medical imaging 
     examinations and radiation therapy treatments; and
       (2) to ensure the safety and accuracy of medical imaging 
     examinations and radiation therapy treatments.

     SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION THERAPY.

       Part F of title III of the Public Health Service Act (42 
     U.S.C. 262 et seq.) is amended by adding at the end the 
     following:

           ``Subpart 4--Medical Imaging and Radiation Therapy

     ``SEC. 355. QUALITY OF MEDICAL IMAGING AND RADIATION THERAPY.

       ``(a) In General.--The Secretary shall establish standards 
     to assure the safety and accuracy of medical imaging or 
     radiation therapy. Such standards shall include licensure or 
     certification, accreditation, and other requirements 
     determined by the Secretary to be appropriate.
       ``(b) Exemptions.--The standards established under 
     subsection (a) shall not apply to physicians (as defined in 
     section 1861(r) of the Social Security Act (42 U.S.C. 
     1395x(r))), nurse practitioners and physician assistants (as 
     defined in section 1861(aa)(5) of the Social Security Act (42 
     U.S.C. 1395x(aa)(5))).
       ``(c) Requirements.--Under the standards established under 
     subsection (a), the Secretary shall ensure that individuals 
     prior to performing or planning such imaging or therapy--
       ``(1) have successfully completed a national examination 
     approved by the Secretary under subsection (d) for 
     individuals who perform or plan medical imaging or radiation 
     therapy; and
       ``(2) meet such other requirements relating to medical 
     imaging or radiation therapy as the Secretary may prescribe.
       ``(d) Approved Bodies.--
       ``(1) In general.--The Secretary shall certify private 
     nonprofit organizations or State agencies as approved bodies 
     with respect to the accreditation of educational programs or 
     the administration of examinations to individuals for 
     purposes of subsection (c)(1) if such organizations or 
     agencies meet the standards established by the Secretary 
     under paragraph (2) and provide the assurances required under 
     paragraph (3).
       ``(2) Standards.--The Secretary shall establish minimum 
     standards for the certification of approved bodies under 
     paragraph (1) (including standards for recordkeeping, the 
     approval of curricula and instructors, the charging of 
     reasonable fees for accreditation or for undertaking 
     examinations), and other additional standards as the 
     Secretary may require.
       ``(3) Assurances.--To be certified as an approved body 
     under paragraph (1), an organization or agency shall provide 
     the Secretary satisfactory assurances that the body will--
       ``(A) comply with the standards described in paragraph (2);
       ``(B) notify the Secretary in a timely manner before the 
     approved body changes the standards of the body; and
       ``(C) provide such other information as the Secretary may 
     require.
       ``(4) Withdrawal of approval.--
       ``(A) In general.--The Secretary may withdraw the 
     certification of an approved body if the Secretary determines 
     the body does not meet the standards under paragraph (2).
       ``(B) Effect of withdrawal.--If the Secretary withdraws the 
     certification of an approved body under subparagraph (A), the 
     accreditation of an individual or the completion of an 
     examination administered by such body shall continue in 
     effect until the expiration of a reasonable period, as 
     determined by the Secretary, for such individual to obtain 
     another accreditation or to complete another examination.
       ``(e) Existing State Standards.--Standards for the 
     licensure or certification of personnel, accreditation of 
     educational programs, or administration of examinations,

[[Page S7491]]

     established by a State prior to the effective date of the 
     standards promulgated under this section, shall be deemed to 
     be in compliance with the requirements of this section unless 
     the Secretary determines that such State standards do not 
     meet the minimum standards prescribed by the Secretary or are 
     inconsistent with the purposes of this section.
       ``(f) Evaluation and Report.--The Secretary shall 
     periodically evaluate the performance of each approved body 
     under subsection (d) at an interval determined appropriate by 
     the Secretary. The results of such evaluations shall be 
     included as part of the report submitted to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives in accordance with 354(e)(6)(B).
       ``(g) Delivery of and Payment for Services.--Not later than 
     18 months after the date of enactment of this section, the 
     Secretary shall promulgate regulations to ensure that all 
     programs that involve the performance of or payment for 
     medical imaging or radiation therapy, that are under the 
     authority of the Secretary, are performed in accordance with 
     the standards established under this section.
       ``(h) Alternative Standards for Rural Areas.--The Secretary 
     shall determine whether the standards developed under 
     subsection (a) must be met in their entirety with respect to 
     payment for medical imaging or radiation therapy that is 
     performed in a geographic area that is determined by the 
     Medicare Geographic Classification Review Board to be a 
     ``rural area''. If the Secretary determines that alternative 
     standards for such rural areas are appropriate to assure 
     access to quality medical imaging, the Secretary is 
     authorized to develop such alternative standards. Alternative 
     standards developed under this subsection shall apply in 
     rural areas to the same extent and in the same manner as 
     standards developed under subsection (a) apply in other 
     areas.
       ``(i) Regulations.--Not later than 18 months after the date 
     of enactment of this section, the Secretary shall promulgate 
     such regulations as may be necessary to implement this 
     section.
       ``(j) Definitions.--In this section:
       ``(1) Approved body.--The term `approved body' means a 
     nonprofit organization or State agency that has been 
     certified by the Secretary under subsection (d)(1) to 
     accredit or administer examinations to individuals who 
     perform or plan medical imaging or radiation therapy.
       ``(2) Medical imaging.--The term `medical imaging' means 
     any procedure or article, excluding medical ultrasound 
     procedures, intended for use in the diagnosis or treatment of 
     disease or other medical or chiropractic conditions in 
     humans, including diagnostic X-rays, nuclear medicine, and 
     magnetic resonance procedures.
       ``(3) Perform.--The term `perform', with respect to medical 
     imaging or radiation therapy, means--
       ``(A) the act of directly exposing a patient to radiation 
     via ionizing or radio frequency radiation or to a magnetic 
     field for purposes of medical imaging or for purposes of 
     radiation therapy; and
       ``(B) the act of positioning a patient to receive such an 
     exposure.
       ``(4) Plan.--The term `plan' with respect to medical 
     imaging or radiation therapy, means the act of preparing for 
     the performance of such a procedure to a patient by 
     evaluating site-specific information, based on measurement 
     and verification of radiation dose distribution, computer 
     analysis, or direct measurement of dose, in order to 
     customize the procedure for the patient.
       ``(5) Radiation therapy.--The term `radiation therapy', 
     means any procedure or article intended for use in the cure, 
     mitigation, treatment, or prevention of disease in humans 
     that achieves its intended purpose through the emission of 
     radiation.''.
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