[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3338 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 3338

 To amend the Public Health Service Act and title XVIII of the Social 
 Security Act to make the provision of technical services for medical 
   imaging examinations and radiation therapy treatments safer, more 
                       accurate, and less costly.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 25, 2012

   Mr. Enzi (for himself, Mr. Harkin, and Mr. Wicker) 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 and title XVIII of the Social 
 Security Act to make the provision of technical services for medical 
   imaging examinations and radiation therapy treatments safer, more 
                       accurate, and less costly.

    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 ``Consistency, Accuracy, 
Responsibility, and Excellence in Medical Imaging and Radiation Therapy 
Act of 2012''.

SEC. 2. PURPOSE.

    The purpose of this Act is to improve the quality and value of 
health care by increasing the safety and accuracy of medical imaging 
examinations and radiation therapy procedures, thereby reducing 
duplication of services and decreasing costs.

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) Qualified Personnel.--
            ``(1) In general.--Effective 42 months after the date of 
        enactment of this section, personnel who perform or plan the 
        technical component of either medical imaging examinations or 
        radiation therapy procedures for medical purposes shall be 
        fully qualified under this section to perform or plan such 
        services.
            ``(2) Qualifications.--Individuals qualified to perform or 
        plan the technical component of medical imaging examinations or 
        radiation therapy procedures shall--
                    ``(A) possess current certification in the medical 
                imaging or radiation therapy modality or service they 
                plan or perform from a certification organization 
                designated under subsection (b); and
                    ``(B) if a State requires the possession of 
                licensure, certification, or registration, possess 
                current State licensure or certifications where such 
                services and modalities are within the scope of 
                practice as defined by the State for such profession.
            ``(3) State licensure, certification, or registration.--
                    ``(A) In general.--Nothing in this section shall be 
                construed to diminish the authority of a State to 
                define requirements for licensure, certification, or 
                registration, the requirements for practice, or the 
                scope of practice of personnel.
                    ``(B) Limitation.--The Secretary shall not take any 
                action under this section that would require licensure 
                by a State of personnel who perform or plan the 
                technical component of medical imaging examinations or 
                radiation therapy procedures.
            ``(4) Exemptions.--
                    ``(A) In general.--The qualification standards 
                described in this subsection and the payment provisions 
                in section 1848(b)(4)(E) of the Social Security Act 
                shall not apply to physicians (as defined in section 
                1861(r) of the Social Security Act (42 U.S.C. 
                1395x(r))) or to nurse practitioners and physician 
                assistants (each as defined in section 1861(aa)(5) of 
                the Social Security Act (42 U.S.C. 1395x(aa)(5))). Such 
                practitioners shall not be included under the terms 
                `personnel' or `qualified personnel' for purposes of 
                this section.
                    ``(B) Individuals currently enrolled.--Individuals 
                currently enrolled in a nuclear medicine, radiation 
                therapy, or medical physicist training or certification 
                program as of the date the Secretary publishes the list 
                of approved certification organizations shall have 6 
                months from the date of completion of the training 
                program to become fully qualified as required under 
                subsection (a).
    ``(b) Designation of Certification Organizations.--
            ``(1) In general.--The Secretary shall establish a program 
        for designating medical imaging or radiation therapy 
        certification organizations that the Secretary determines have 
        established appropriate procedures and programs for certifying 
        personnel as qualified to furnish medical imaging or radiation 
        therapy services. In establishing such program, the Secretary 
        shall consult with professional organizations and recognized 
        experts in the technical component of medical imaging and 
        radiation therapy services.
            ``(2) Factors.--
                    ``(A) In general.--When designating certification 
                organizations under this subsection, and when reviewing 
                or modifying the list of designated organizations for 
                the purposes of paragraph (4)(B), the Secretary--
                            ``(i) shall consider--
                                    ``(I) whether the certification 
                                organization has established a process 
                                for the timely integration of new 
                                medical imaging or radiation therapy 
                                services into the organization's 
                                certification program;
                                    ``(II) whether the certification 
                                organization has established education 
                                and continuing education requirements 
                                for individuals certified by the 
                                organization;
                                    ``(III) whether the certification 
                                organization is a nonprofit 
                                organization;
                                    ``(IV) whether the certification 
                                organization requires completion of a 
                                certification examination as a 
                                prerequisite for certification; and
                                    ``(V) whether the certification 
                                organization has been accredited by an 
                                accrediting body (as defined in 
                                subparagraph (B)) that is approved by 
                                the Secretary; and
                            ``(ii) may consider--
                                    ``(I) whether the certification 
                                organization has established reasonable 
                                fees to be charged to those applying 
                                for certification; and
                                    ``(II) the ability of the 
                                certification organization to review 
                                applications for certification in a 
                                timely manner.
                    ``(B) Accrediting body.--For purposes of this 
                section, the term `accrediting body' means and 
                organization that--
                            ``(i) is a nonprofit organization;
                            ``(ii) is a national or international 
                        organization with accreditation programs for 
                        examinations leading to certification by 
                        certification organizations; and
                            ``(iii) has established standards for 
                        recordkeeping and to minimize the possibility 
                        of conflicts of interest.
            ``(3) Equivalent education, training, and experience.--
                    ``(A) In general.--For purposes of this section, 
                the Secretary shall, through regulation, provide a 
                process for individuals whose training or experience 
                are determined to be equal to, or in excess of, those 
                of a graduate of an accredited educational program in 
                that specialty to demonstrate their experience meets 
                the educational standards for qualified personnel in 
                their imaging modality or radiation therapy procedures. 
                Such process may include documentation of items such 
                as--
                            ``(i) years and type of experience;
                            ``(ii) a list of settings where experience 
                        was obtained; and
                            ``(iii) verification of experience by 
                        supervising physicians or clinically qualified 
                        hospital personnel.
                    ``(B) Eligibility.--The Secretary shall not 
                recognize any individual as having met the educational 
                standards applicable under this paragraph based on 
                experience pursuant to the authority of subparagraph 
                (A) unless such individual was performing or planning 
                the technical component of medical imaging examinations 
                or radiation therapy treatments prior to the date of 
                enactment of this section.
            ``(4) Process.--
                    ``(A) Regulations.--Not later than 12 months after 
                the date of enactment of this section, the Secretary 
                shall promulgate regulations for designating 
                certification organizations pursuant to this 
                subsection.
                    ``(B) Designations and list.--Not later than 18 
                months after the date of enactment of this section, the 
                Secretary shall make determinations regarding all 
                certification organizations that have applied for 
                designation pursuant to the regulations promulgated 
                under subparagraph (A), and shall publish a list of all 
                certification organizations that have received a 
                designation.
                    ``(C) Periodic review and revision.--The Secretary 
                shall periodically review the list under subparagraph 
                (B), taking into account the factors established under 
                paragraph (2). After such review, the Secretary may, by 
                regulation, modify the list of certification 
                organizations that have received such designation.
                    ``(D) Withdrawal of approval.--The Secretary may 
                withdraw the approval of a certification organization 
                listed under subparagraph (B) if the Secretary 
                determines that the body no longer meets the 
                requirements of subsection (b).
                    ``(E) Certifications prior to removal from list.--
                If the Secretary removes a certification organization 
                from the list of certification organizations designated 
                under subparagraph (B), any individual who was 
                certified by the certification organization during or 
                before the period beginning on the date on which the 
                certification organization was designated as a 
                certification organization under such subparagraph, and 
                ending 12 months from the date on which the 
                certification organization is removed from such list, 
                shall be considered to have been certified by a 
                certification organization designated by the Secretary 
                under such subparagraph for the remaining period that 
                such certification is in effect.
    ``(c) Alternative Standards for Rural and Underserved Areas.--The 
chief executive officer of a State may submit to the Secretary a 
statement declaring that the requirements described in subsection (a) 
are inappropriate for application for medical imaging examinations or 
radiation therapy procedures that are performed and planned in a 
geographic area that is determined by the Medicare Geographic 
Classification Review Board to be a `rural area' or that is designated 
as a health professional shortage area. Upon receipt of such statement, 
if the Secretary deems it appropriate, the Secretary may waive the 
standards described in subsection (a) or develop alternative standards 
for such rural areas or health professional shortage areas.
    ``(d) Rule of Construction.--Notwithstanding any other provision of 
this section, individuals who provide medical imaging examinations 
relating to mammograms shall continue to meet the regulations 
applicable under the Mammography Quality Standards Act of 1992.
    ``(e) Definition.--As used in this section:
            ``(1) Medical imaging.--The term `medical imaging' means 
        any examination or procedure used to visualize tissues, organs, 
        or physiologic processes in humans for the purpose of 
        detecting, diagnosing, treating, or impacting the progression 
        of disease or illness. For purposes of this section, such term 
        does not include routine dental or ophthalmologic diagnostic 
        procedures or ultrasound guidance of vascular access 
        procedures.
            ``(2) Perform.--The term `perform', with respect to medical 
        imaging or radiation therapy, means--
                    ``(A) the act of directly exposing a patient to 
                radiation, including ionizing or radio frequency 
                radiation, to ultrasound, 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.
            ``(3) Plan.--The term `plan', with respect to medical 
        imaging or radiation therapy, means the act of preparing for 
        the performance of such a procedure on 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.
            ``(4) 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 ionizing 
        or non-ionizing radiation.''.

SEC. 4. STANDARDS FOR MEDICAL IMAGING AND RADIATION THERAPY.

    Section 1848(b)(4) of the Social Security Act (42 U.S.C. 1395w-
4(b)(4)) is amended by adding at the end the following new 
subparagraph:
                    ``(E) Standards for medical imaging and radiation 
                therapy.--With respect to expenses incurred for the 
                planning and performing of the technical component of 
                medical imaging examinations or radiation therapy 
                procedures (as defined in subsection (f) of section 355 
                of the Public Health Service Act) furnished on or after 
                42 months after date of enactment of the Consistency, 
                Accuracy, Responsibility, and Excellence in Medical 
                Imaging and Radiation Therapy Act of 2012, payment 
                shall be made under this section only if the 
                examination or procedure is planned or performed by an 
                individual who meets the standards established by the 
                Secretary under such section 355.''.

SEC. 5. REPORT ON THE EFFECTS OF THIS ACT.

    (a) In General.--Not later than 5 years after the date of enactment 
of this Act, the Secretary of Health and Human Services, shall submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate, the Committee on Finance of the Senate, and the Committee on 
Energy and Commerce of the House of Representatives, a report on the 
effects of this Act.
    (b) Requirements.--The report under subsection (a) shall include 
the types and numbers of individuals qualified to perform or plan the 
technical component of medical imaging or radiation therapy services 
for whom standards have been developed, the impact of such standards on 
diagnostic accuracy and patient safety, and the availability and cost 
of services. Entities reimbursed for technical services through 
programs operating under the authority of the Secretary of Health and 
Human Services shall be required to contribute data to such report.
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