Draft Licensure Bill

June 30, 2003

Draft Licensure Bill  

To amend Title 42 U.S.C., Chapter 107, the Consumer-Patient Radiation Health and Safety Act, and to assure the quality of diagnostic and therapeutic radiologic patient care.

IN THE HOUSE OF REPRESENTATIVES OR SENATE

Sponsor introduced the following bill; which was referred to the House or Senate Committee.

A BILL

To provide public access to quality medical imaging and radiation therapy procedures:

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

Section 101. Short Title

Sec. 975. This subtitle may be cited as the "Consumer-Patient Radiation Health and Safety Act of 1981".

This act will be cited after amendment as the "Medical Imaging and Radiation Therapy Quality Assurance Act of 1999."

Section 102. Statement of Findings

Sec. 976. The Congress finds that—

(1) it is the interest of public health and safety to minimize unnecessary exposure to potentially hazardous radiation due to medical and dental radiologic procedures;

(1) it is in the interest of public health and safety to assure quality medical imaging and radiation therapy procedures;

(2) it is in the interest of the public health and safety to have a continuing supply of adequately educated persons and appropriate accreditation and certification programs administered by State governments;

(2) it is in the interest of public health and safety to have a continuing supply of adequately educated and credentialed persons who administer medical imaging and radiation therapy procedures pursuant to recognized accreditation and credentialing programs in accordance with standards promulgated by the Federal Government in 42 C.F.R., Part 75;

(3) the protection of the public health and safety from unnecessary exposure to potentially hazardous radiation due to medical and dental radiologic procedures and the assurance of efficacious procedures are the responsibility of State and Federal governments;

(3) it is the responsibility of the Federal Government to protect the public health from improperly performed medical imaging and radiation therapy procedures, and to assure effective diagnostic and therapeutic procedures, evidenced by provisions specifying educational and certification standards for mammographers in the Mammography Quality Standards Act of 1992; and

(4) persons who administer radiologic procedures, including procedures at Federal facilities, should be required to demonstrate competence by reason of education, training, and experience; and

(4) persons who administer medical imaging and radiation therapy procedures, including procedures at Federal facilities, should be required to demonstrate competence by reason of education, experience and examination.

(5) the administration of radiologic procedures and the effect on individuals of such procedures have a substantial and direct effect upon United States interstate commerce.

Sec. 103. Statement of Purpose

Sec. 977. It is the purpose of this subtitle to—

(1) provide for the establishment of minimum standards by the Federal Government for the accreditation of education programs for persons who administer radiologic procedures and for the certification of such persons; and

(1) provide for the promulgation of minimum standards by the Federal Government for accreditation of educational programs for persons who administer medical imaging and radiation therapy procedures;

(2) insure that medical and dental radiologic procedures are consistent with rigorous safety precautions and standards.

(2) provide for the promulgation of minimum standards by the Federal Government for credentialing of persons who administer medical imaging and radiation therapy procedures to consumer-patients;

(3) ensure that all activities conducted or funded by Federal agencies are consistent with the purposes of this Act; and

(4) encourage state recognition of qualified mechanisms for the accreditation of educational programs for persons who administer medical imaging and radiation therapy procedures and for the credentialing of those persons.

Sec. 104. Definitions

Sec. 978. Unless otherwise expressly provided, for purposes of this subtitle, the term—

(1) "radiation" means ionizing and nonionizing radiation in amounts beyond normal background levels from sources such as medical and dental radiologic procedures;

(1) "medical imaging" means any procedure or article intended for use in the diagnosis of disease or other medical or dental conditions in humans (including, but not limited to, diagnostic X-rays, nuclear medicine and magnetic resonance procedures);

(2) "radiologic procedure" means any procedure or article intended for use in—

(A) the diagnosis of disease or other medical or dental conditions in humans (including diagnostic X-rays or nuclear medicine procedures); or

(B) the cure, mitigation, treatment, or prevention of disease in humans; that achieves its intended purpose through the emission of radiation;

(2) "persons who administer medical imaging or radiation therapy procedures" means any person, other than a licensed practitioner, who intentionally administers medical imaging or radiation therapy procedures to other persons for medical purposes, and includes medical radiologic technologists (including dental hygienists and assistants), radiation therapists, nuclear medicine technologists, and does not include persons who perform diagnostic medical sonography. Students enrolled in accredited educational programs may perform medical imaging and radiation therapy procedures under the supervision of a person who administers medical imaging or radiation therapy procedures under this Act;

(3) "radiologic equipment" means any radiation electronic product which emits or detects radiation and which is used or intended for use to—

(A) diagnose disease or other medical or dental conditions (including diagnostic x-ray equipment); or

(B) cure, mitigate, treat, or prevent disease in humans; that achieves its intended purpose through the emission or detection of radiation;

(3) "practitioner" means any licensed doctor of medicine, osteopathy, dentistry, podiatry or chiropractic;

(4) "practitioner" means any licensed doctor of medicine, osteopathy, dentistry, podiatry, or chiropractic, who prescribes radiologic procedures for other persons;

(4) "radiation therapy" means any radiation procedure or article intended for the cure, mitigation or prevention of disease in humans;

(5) "persons who administer radiologic procedures" means any person, other than a practitioner, who intentionally administers radiation to other persons for medical purposes, and includes medical radiologic technologists (including dental hygienists and assistants), radiation therapy technologists, and nuclear medicine technologists;

(5)(6) "Secretary" means the Secretary of Health and Human Services; and

(6)(7) "State" means the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.

Sec. 105. Promulgation of Standards

Sec. 979. (a) Within twelve months after the date of enactment of this Act, the Secretary, in consultation with the Radiation Policy Council, the Administrator of Veterans’ Affairs, the Administrator of the Environmental Protection Agency, appropriate agencies of the States, and appropriate professional organizations, shall by regulation promulgate minimum standards for the accreditation of educational programs to train individuals to perform radiologic procedures. Such standards shall distinguish between programs for the education of (1) medical radiologic technologists (including radiographers), (2) dental auxiliaries (including dental hygienists and assistants), (3) radiation therapy technologists, (4) nuclear medicine technologists, and (5) such other kinds of health auxiliaries who administer radiologic procedures as the Secretary determines appropriate. Such standards shall not be applicable to educational programs for practitioners.

(a) Within eighteen (18) months of enactment the Secretary shall revise the existing standards for accreditation of educational programs conducted by institutions for persons who administer medical imaging and radiation therapy procedures to reflect current educational requirements for quality performance of medical imaging and radiation therapy procedures. Such standards shall include minimum accreditation criteria for institutions in areas of administrative policies and procedures, curricula, recordkeeping, faculty, administrative support, and such other criteria as the Secretary shall deem necessary for the adequate education of persons who administer medical imaging and radiation therapy procedures.

(b) Within twelve months after the date of enactment of this Act, the Secretary, in consultation with the Radiation Policy Council, the Administrator of Veterans’ Affairs, the Administrator of the Environmental Protection Agency, interested agencies of the States, and appropriate professional organizations, shall by regulation promulgate minimum standards for the certification of persons who administer radiologic procedures. Such standards shall distinguish between certification of (1) medical radiologic technologists (including radiographers), (2) dental auxiliaries (including dental hygienists and assistants), (3) radiation therapy technologists, (4) nuclear medicine technologists, and (5) such other kinds of health auxiliaries who administer radiologic procedures as the Secretary determines appropriate. Such standards shall include minimum certification criteria for individuals with regard to accredited education, practical experience, successful passage of required examinations, and such other criteria a the Secretary shall deem necessary for the adequate qualification of individuals to administer radiologic procedures. Such standards shall not apply to practitioners.

(b) Within eighteen (18) months of enactment the Secretary shall revise the existing standards for the credentialing of persons who administer medical imaging and radiation therapy procedures to patients, reflecting current requirements for quality performance of medical imaging and radiation therapy procedures. Such standards shall include minimum criteria for individuals to include educational preparation, practical experience, successful examination and such other criteria as the Secretary shall deem necessary for the adequate qualification of persons who administer medical imaging and radiation therapy procedures.

Sec. 106. Model Statute

Sec. 980. In order to encourage the administration of accreditation and certification programs by the States, the Secretary shall prepare and transmit to the States a model statute for radiologic procedure safety. Such model statute provide that—

The Secretary shall provide the States such advice or assistance as will foster adoption and administration of programs to achieve the purposes of this Act. Such advice and assistance shall include, but shall not be limited to, the preparation of a model law for quality medical imaging and radiation therapy. Such model law shall provide that it shall be unlawful in a State for persons to perform medical imaging and radiation therapy procedures unless they satisfy standards administered by the states that comply with Section 979 of this Act.

(1) it shall be unlawful in a State for individuals to perform radiologic procedures unless such individuals are certified by the State to perform such procedures; and

(2) any educational requirements for certification of individuals to perform radiologic procedures shall be limited to educational programs accredited by the State.

Sec. 107. Compliance

Sec. 981. (a) The Secretary shall take all actions consistent with law to effectuate the purposes of this subtitle.

(b) A State may utilize an accreditation or certification program credentialing mechanism administered by a private entity if—

(1) such State delegates the administration of the State accreditation or certification program credentialing mechanism to such private entity;

(2) such program mechanism is approved by the State; and

(3) such program mechanism is consistent with the minimum Federal standards promulgated under this subtitle for such program mechanism.

(c) Absent compliance by the States with the provisions of this subtitle within three years after the date of enactment of this Act, the Secretary shall report to the Congress recommendations for legislative changes considered necessary to assure the States’ compliance with this subtitle.

(d) (c) Notwithstanding any other provision of this section, in the case of a State which has, prior to the effective date of standards and guidelines promulgated pursuant to this subtitle, established standards for the accreditation of educational programs and certification credentialing of radiologic technologists persons who administer medical imaging and radiation therapy procedures, such State shall be deemed to be in compliance with the conditions of this section unless the Secretary determines, after notice and hearing, that such State standards do not meet the minimum standards prescribed by the Secretary or are inconsistent with the purposes of this subtitle.

Sec. 108. Federal Radiation Guidelines

SEC. 982. The Secretary shall, in conjunction with the Radiation Policy Council, the Administrator of Veterans’ Affairs, the Administrator of the Environmental Protection Agency appropriate Federal and State agencies and professional organizations, appropriate agencies of the States, and appropriate professional organizations; promulgate Federal radiation guidelines with respect to radiologic medical imaging and radiation therapy procedures. Such guidelines shall—

(1) determine the level of radiation exposure due to radiologic procedures which is unnecessary and specify the techniques, procedures, and methods to minimize such unnecessary exposure;

(2) provide for the elimination of the need for retakes of diagnostic radiologic procedures;

(3) provide for the elimination of unproductive screening programs;

(4)(1) provide for the optimum diagnostic information with minimum radiologic patient exposure; and

(5)(2) include the therapeutic application of radiation to individuals in the treatment of disease, including nuclear medicine applications.

Sec. 109. Applicability to Federal Agencies

SEC. 983. (a) Except as provided in subsection (b), each department, agency, and instrumentality of the executive branch of the Federal Government shall comply with standards promulgated pursuant to this section.

(b)(1) The Administrator of Veterans’ Affairs, through the Chief Medical Director of the Veterans’ Administration, shall, to the maximum extent feasible consistent with the responsibilities of such Administrator and Chief Medical Director under subtitle 38, United States Code, prescribe regulations making the standards promulgated pursuant to this subtitle applicable to the provision of radiologic medical imaging and radiation therapy procedures in facilities over which the Administrator has jurisdiction. In prescribing and implementing regulations pursuant to this subsection, the Administrator shall consult with the Secretary in order to achieve the maximum possible coordination of the regulations, standards, and guidelines, and the implementation thereof, which the Secretary and the Administrator prescribe under this subtitle.

(2) Not later than 180 days after standards are promulgated by the Secretary pursuant to this subtitle, the Administrator of Veterans’ Affairs shall submit to the appropriate committees of Congress a full report with respect to the regulations (including guidelines, policies, and procedures thereunder) prescribed pursuant to paragraph (1) of this subsection. Such report shall include—

(A) an explanation of any inconsistency between standards made applicable by such regulations and the standards promulgated by the Secretary pursuant to this subtitle;

(B) an account of the extent, substance, and results of consultations with the Secretary respecting the prescription and implementation of regulations by the Administrator; and

(C) such recommendations for legislation and administrative action as the Administrator determines are necessary and desirable.

(3) The Administrator of Veterans’ Affairs shall publish the report required by paragraph (2) in the Federal Register.

Sec. 110.

SEC. 984. (a) Each department, agency and instrumentality of the executive branch of the Federal Government shall comply with any minimum standards promulgated pursuant to this Act.

(b) In order to carry out the purposes of this Act, five (5) years after the date of its enactment, Congress shall make a state’s participation in Federal Medicaid waiver programs contingent upon compliance with the mandates of this Act.

Sec. 111.

SEC. 985. There is authorized to be appropriated to the Secretary such sums as necessary to carry out the purposes of this Act.