[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1197 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                S. 1197

    To amend the Public Health Service Act to ensure the safety and 
    accuracy of medical imaging examinations and radiation therapy 
                              treatments.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 5, 2003

 Mr. Enzi (for himself, Mr. Kennedy, Mr. Daschle, Mr. Lautenberg, and 
  Mr. Dorgan) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To amend the Public Health Service Act to ensure the safety and 
    accuracy of medical imaging examinations and radiation therapy 
                              treatments.

    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, 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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