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.

Summary: Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service provided from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants.

Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a method for the recognition of 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; and (4) approve and publish a list of accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to assure access to quality medical imaging.

Amends the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services furnished on or after January 1, 2013, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Consistency, Accuracy, 
Responsibility, and Excellence in Medical Imaging and Radiation Therapy 
Act of 2009''.

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 must be qualified under this section to 
        perform or plan such services.
            ``(2) Qualification.--Individuals qualified to perform or 
        plan the technical component of medical imaging examinations or 
        radiation therapy procedures must--
                    ``(A) possess current certification in each medical 
                imaging or radiation therapy modality and service 
                provided 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) Nothing in this section diminishes 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) The Secretary shall not take any action under 
                this section that would require licensure by a State of 
                those who perform or plan the technical component of 
                medical imaging examinations or radiation therapy 
                procedures.
            ``(4) Exemptions.--The qualification standards described in 
        this subsection 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))).
    ``(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) Experts.--For the purposes of this subsection, the 
        Secretary shall select expert advisers to reflect a broad and 
        balanced input from all sectors of the health care community 
        that are involved in the provision of such services to avoid 
        undue influence from any single sector of practice on the 
        content of such standards.
            ``(3) Minimum standards.--Minimum standards may vary in 
        form for each of the covered disciplines, reflecting the unique 
        or specialized nature of the technical services provided, and 
        shall represent expert consensus from those practicing in each 
        of the covered disciplines 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 
        higher standards than the minimum standards specified by the 
        Secretary pursuant to this subsection.
            ``(5) Timeline.--The Secretary shall promulgate regulations 
        for the purposes of carrying out this subsection no later than 
        18 months after the date on which this section is enacted.
    ``(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, 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 
                method for the recognition of 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. Such authority 
                shall expire seven years after the enactment of this 
                section.
                    ``(B) Eligibility.--The Secretary shall not 
                recognize any individual pursuant to the authority of 
                subparagraph (A) unless such individual--
                            ``(i) was performing or planning the 
                        technical component of medical imaging 
                        examinations or radiation therapy treatments 
                        prior to enactment of this section; and
                            ``(ii) is ineligible to take the licensure 
                        or certification examination for that 
                        discipline.
            ``(4) Process.--
                    ``(A) Regulations.--The Secretary shall, by July 1, 
                2012, promulgate regulations for designating 
                certification organizations pursuant to this paragraph.
                    ``(B) Designations and list.--The Secretary shall, 
                by January 1, 2013, 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 
                designation.
                    ``(C) Periodic review and revision.--The Secretary 
                shall periodically review the list, 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 
                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 subparagraph (B) 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 
                subparagraph (B) for the remaining period that such 
                certification is in effect.
    ``(d) Approved Accrediting Bodies.--
            ``(1) In general.--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 publish the list no later than 24 months after 
        enactment of this section and shall revise the list as 
        appropriate.
            ``(2) Requirements for approval.--The Secretary shall not 
        approve an accrediting body for certification organizations 
        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 if the Secretary determines 
        that the body does not meet the standards defined in 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 
        assure 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) Definitions.--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 diagnostic procedures or 
        advanced imaging procedures as defined in section 1834(e)(1)(B) 
        of the Social Security Act.
            ``(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 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.
            ``(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. PAYMENT AND 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--
            (1) in subparagraph (A), by striking the ``imaging'' and 
        inserting ``medical imaging and radiation therapy'' and;
            (2) by adding at the end the following new subparagraph:
                    ``(C) Payment 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 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 section 355 of the Public Health 
                Service Act.''.

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

    (a) In General.--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 no later than 5 years after the date 
of the enactment of this Act.
    (b) Requirements.--Such report 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.