[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3737 Introduced in Senate (IS)]

111th CONGRESS
  2d Session
                                S. 3737

 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

                             August 5, 2010

     Mr. Enzi (for himself, Mr. Harkin, Mr. Burr, and Mr. Franken) 
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 2010''.

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 January 1, 2013, personnel who 
        perform or plan the technical component of either medical 
        imaging examinations or radiation therapy procedures for 
        medical purposes shall be 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 by the Secretary pursuant to subsection (c); 
                or
                    ``(B) possess current State licensure or 
                certification, where--
                            ``(i) such services and modalities are 
                        within the scope of practice as defined by the 
                        State for such profession; and
                            ``(ii) the requirements for licensure, 
                        certification, or registration meet or exceed 
                        the standards established by the Secretary 
                        pursuant to this section.
            ``(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.--The qualification standards described in 
        this subsection and the payment provisions in section 
        1848(b)(4)(C) 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) Establishment of Standards.--
            ``(1) In general.--For the purposes of determining 
        compliance with subsection (a), the Secretary, in consultation 
        with recognized experts in the technical provision of medical 
        imaging or radiation therapy services, shall establish minimum 
        standards for personnel who perform, plan, evaluate, or verify 
        patient dose for medical imaging examinations or radiation 
        therapy procedures. Such standards shall not apply to the 
        equipment used.
            ``(2) Recognized experts.--
                    ``(A) In general.--For the purposes of this 
                subsection, the Secretary shall select recognized 
                expert advisers to reflect a broad and balanced input 
                from all sectors of the health care community that are 
                involved in the provision of services of the type 
                described in paragraph (1) to avoid undue influence 
                from any single sector of practice relating to the 
                content of such standards.
                    ``(B) Definition.--In this paragraph, the term 
                `recognized experts' includes--
                            ``(i) representatives of all medical 
                        specialties and providers that perform or plan 
                        medical imaging procedures;
                            ``(ii) representatives of all medical 
                        specialties and providers that perform or plan 
                        radiation therapy procedures;
                            ``(iii) medical imaging and radiation 
                        therapy technology experts; and
                            ``(iv) other experts determined appropriate 
                        by the Secretary.
            ``(3) Minimum standards.--Minimum standards established 
        under this subsection shall reflect the unique or specialized 
        nature of the technical services provided, and shall represent 
        expert consensus from those practicing in each of the covered 
        imaging modalities and radiation therapy procedures as to what 
        constitutes excellence in practice and be appropriate to the 
        particular scope of care involved.
            ``(4) Allowance for additional standards.--Nothing in this 
        subsection shall be construed to prohibit a State or 
        certification organization from requiring compliance with 
        standards that exceed the minimum standards specified by the 
        Secretary pursuant to this subsection.
            ``(5) Timeline.--Not later than 12 months after the date of 
        enactment of this section, the Secretary shall promulgate 
        regulations for the purposes of carrying out this subsection.
    ``(c) Designation of Certification Organizations.--
            ``(1) In general.--The Secretary shall establish a program 
        for designating 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.
            ``(2) Factors.--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 shall consider--
                    ``(A) whether the certification organization has 
                established certification requirements for individuals 
                that are consistent with or exceed the minimum 
                standards established in subsection (b);
                    ``(B) 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;
                    ``(C) whether the certification organization has 
                established education and continuing education 
                requirements for individuals certified by the 
                organization;
                    ``(D) whether the organization has established 
                reasonable fees to be charged to those applying for 
                certification;
                    ``(E) whether the examinations leading to 
                certification by the certification organization are 
                accredited by an appropriate accrediting body as 
                defined in subsection (d);
                    ``(F) the ability of the certification organization 
                to review applications for certification in a timely 
                manner; and
                    ``(G) such other factors as the Secretary 
                determines appropriate.
            ``(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
                    ``(C) Certification test requirement.--To be 
                eligible to be certified under this subsection an 
                individual shall, not later than 18 months after the 
                date on which the list of designated certification 
                organizations is published under paragraph (4), 
                successfully complete a certification examination 
                administered by a designated certification 
                organization. During such 18-month period, the 
                penalties provided for under section 1848(b)(4)(C) of 
                the Social Security Act (as added by section 4 of the 
                Consistency, Accuracy, Responsibility, and Excellence 
                in Medical Imaging and Radiation Therapy Act of 2010) 
                shall not apply to such individuals.
            ``(4) Process.--
                    ``(A) Regulations.--Not later than July 1, 2012, 
                the Secretary shall promulgate regulations for 
                designating certification organizations pursuant to 
                this subsection.
                    ``(B) Designations and list.--Not later than 
                January 1, 2013, 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) 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 on 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.
    ``(d) Approved Accrediting Bodies.--
            ``(1) In general.--Not later than 24 months after the date 
        of enactment of this section, the Secretary shall publish a 
        list of entities that are approved accrediting bodies for 
        certification organizations for purposes of subsection 
        (c)(2)(E). The Secretary shall revise such list as appropriate.
            ``(2) Requirements for approval.--The Secretary shall not 
        approve an accrediting body for certification organizations 
        under this subsection unless the Secretary determines that such 
        accrediting body--
                    ``(A) is a nonprofit organization;
                    ``(B) is a national or international organization 
                with accreditation programs for examinations leading to 
                certification by certification organizations;
                    ``(C) has established standards for recordkeeping 
                and to minimize the possibility of conflicts of 
                interest; and
                    ``(D) demonstrates compliance with any other 
                requirements established by the Secretary.
            ``(3) Withdrawal of approval.--The Secretary may withdraw 
        the approval of an accrediting body under this paragraph if the 
        Secretary determines that the body does not meet the 
        requirements of paragraph (2).
    ``(e) Alternative Standards for Rural and Underserved Areas.--
            ``(1) In general.--The Secretary shall determine whether 
        the standards established under subsection (a) must be met in 
        their entirety 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. If the 
        Secretary determines that alternative standards for such rural 
        areas or health professional shortage areas are appropriate to 
        ensure access to quality medical imaging examinations or 
        radiation therapy procedures, the Secretary is authorized to 
        develop such alternative standards.
            ``(2) State discretion.--The chief executive officer of a 
        State may submit to the Secretary a statement declaring that an 
        alternative standard developed under paragraph (1) is 
        inappropriate for application to such State, and such 
        alternative standard shall not apply in such submitting State. 
        The chief executive officer of a State may rescind a statement 
        described in this paragraph following the provision of 
        appropriate notice to the Secretary.
    ``(f) 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 (as 
amended).
    ``(g) 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. REQUIRED 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) Required standards for medical imaging and 
                radiation therapy services.--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 
                (g) of section 355 of the Public Health Service Act) 
                furnished on or after January 1, 2013, payment shall be 
                made under this section only if the examination or 
                procedure is planned or performed by an individual who 
                meets the requirements 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 the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Director of the Agency for Healthcare Research and 
Quality, 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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