article: 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.''.
summary: 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.