text: 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.''.
target: Consumer Assurance of Radiologic Excellence Act of 2003 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to establish standards to assure the safety and accuracy of medical imaging or radiation therapy. States that such standards shall include licensure or certification, accreditation, and other requirements determined by the Secretary.Exempts the standards from applying to physicians, nurse practitioners, and physician assistants.Requires individuals prior to performing or preparing such imaging or therapy to have successfully completed a national exam approved by the Secretary.Directs the Secretary to certify private nonprofit organizations or State agencies as approved bodies with respect to the accreditation of educational programs or the administration of examinations if such organizations or agencies meet certain standards and give certain assurances. Allows the Secretary to withdraw approval from an approved body.Permits the Secretary to develop alternative standards for rural areas if such action is needed to assure access to quality medical imaging.
feat_title: A bill to amend the Public Health Service Act to ensure the safety and accuracy of medical imaging examinations and radiation therapy treatments.