[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2322 Reported in Senate (RS)]






                                                       Calendar No. 668
109th CONGRESS
  2d Session
                                S. 2322

                          [Report No. 109-363]

    To amend the Public Health Service 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

                           February 17, 2006

Mr. Enzi (for himself, Mr. Kennedy, Mr. Bingaman, Mr. Hagel, Mr. Biden, 
  Mr. Domenici, Mr. Durbin, Mr. Cochran, Mr. Johnson, Mr. Conrad, Mr. 
Thune, Mr. Lautenberg, Mr. Isakson, Mr. Lieberman, Mr. Lott, Mr. Burr, 
  Mr. Dodd, Mr. Dorgan, and Mr. Hatch) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                            December 5, 2006

                Reported by Mr. Enzi, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL



    To amend the Public Health Service 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Consumer Assurance of 
Radiologic Excellence Act of 2006''.</DELETED>

<DELETED>SEC. 2. PURPOSE.</DELETED>

<DELETED>    The purpose of this Act is to improve the quality and 
value of healthcare by increasing the safety and accuracy of medical 
imaging examinations and radiation therapy treatments, thereby reducing 
duplication of services and decreasing costs.</DELETED>

<DELETED>SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION 
              THERAPY.</DELETED>

<DELETED>    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:</DELETED>

 <DELETED>``Subpart 4--Medical Imaging and Radiation Therapy</DELETED>

<DELETED>``SEC. 355. QUALITY OF MEDICAL IMAGING AND RADIATION 
              THERAPY.</DELETED>

<DELETED>    ``(a) Establishment of Standards.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in consultation 
        with recognized experts in the technical provision of medical 
        imaging and radiation therapy services, shall establish 
        standards to ensure the safety and accuracy of medical imaging 
        studies and radiation therapy treatments. Such standards shall 
        pertain to the personnel who perform, plan, evaluate, or verify 
        patient dose for medical imaging studies and radiation therapy 
        procedures and not to the equipment used.</DELETED>
        <DELETED>    ``(2) Experts.--The Secretary shall select expert 
        advisers under paragraph (1) 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.</DELETED>
        <DELETED>    ``(3) Limitation.--The Secretary shall not take 
        any action under this subsection that would require licensure 
        by a State of those who provide the technical services referred 
        to in this subsection.</DELETED>
<DELETED>    ``(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))).</DELETED>
<DELETED>    ``(c) Requirements.--</DELETED>
        <DELETED>    ``(1) In general.--Under the standards established 
        under subsection (a), the Secretary shall ensure that 
        individuals, prior to performing or planning medical imaging 
        and radiation therapy services, demonstrate compliance with the 
        standards established under subsection (a) through successful 
        completion of certification by a professional organization, 
        licensure, completion of an examination, pertinent coursework 
        or degree program, verified pertinent experience, or through 
        other ways determined appropriate by the Secretary, or through 
        some combination thereof.</DELETED>
        <DELETED>    ``(2) Miscellaneous provisions.--The standards 
        established under subsection (a)--</DELETED>
                <DELETED>    ``(A) may vary from discipline to 
                discipline, reflecting the unique and specialized 
                nature of the technical services provided, and shall 
                represent expert consensus as to what constitutes 
                excellence in practice and be appropriate to the 
                particular scope of care involved;</DELETED>
                <DELETED>    ``(B) may vary in form for each of the 
                covered disciplines; and</DELETED>
                <DELETED>    ``(C) may exempt individual providers from 
                meeting certain standards based on their scope of 
                practice.</DELETED>
        <DELETED>    ``(3) Recognition of individuals with extensive 
        practical experience.--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, or of 
        an individual who is regularly eligible to take the licensure 
        or certification examination for that discipline.</DELETED>
<DELETED>    ``(d) Approved Bodies.--</DELETED>
        <DELETED>    ``(1) In general.--Not later than the date 
        described in subsection (j)(2), the Secretary shall begin to 
        certify qualified entities as approved bodies with respect to 
        the accreditation of the various mechanisms by which an 
        individual can demonstrate compliance with the standards 
        promulgated under subsection (a), if such organizations or 
        agencies meet the standards established by the Secretary under 
        paragraph (2) and provide the assurances required under 
        paragraph (3).</DELETED>
        <DELETED>    ``(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 certification or for undertaking 
        examinations, and standards to minimize the possibility of 
        conflicts of interest), and other additional standards as the 
        Secretary may require.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) be a nonprofit 
                organization;</DELETED>
                <DELETED>    ``(B) comply with the standards described 
                in paragraph (2);</DELETED>
                <DELETED>    ``(C) notify the Secretary in a timely 
                manner if the body fails to comply with the standards 
                described in paragraph (2); and</DELETED>
                <DELETED>    ``(D) provide such other information as 
                the Secretary may require.</DELETED>
        <DELETED>    ``(4) Withdrawal of approval.--</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(B) Effect of withdrawal.--The 
                withdrawal of the certification of an approved body 
                under subparagraph (A) shall have no effect on the 
                certification status of any individual or person that 
                was certified by that approved body prior to the date 
                of such withdrawal.</DELETED>
<DELETED>    ``(e) Existing State Standards.--Standards established by 
a State for the licensure or certification of personnel, accreditation 
of educational programs, or administration of examinations shall be 
deemed to be in compliance with the standards 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.</DELETED>
<DELETED>    ``(f) Rule of Construction.--Nothing in this section shall 
be construed to prohibit a State or other approved body from requiring 
compliance with a higher standard of education and training than that 
specified by this section.</DELETED>
<DELETED>    ``(g) 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).</DELETED>
<DELETED>    ``(h) Delivery of and Payment for Services.--Not later 
than the date described in subsection (j)(3), the Secretary shall 
promulgate regulations to ensure that all programs under the authority 
of the Secretary that involve the performance of or payment for medical 
imaging or radiation therapy, are performed in accordance with the 
standards established under this section.</DELETED>
<DELETED>    ``(i) Alternative Standards for Rural and Underserved 
Areas.--The Secretary shall determine whether the standards established 
under subsection (a) must be met in their entirety 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' 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, the Secretary is authorized 
to develop such alternative standards.</DELETED>
<DELETED>    ``(j) Applicable Timelines.--</DELETED>
        <DELETED>    ``(1) General implementation 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 all standards in this section except 
        those provided for in subsection (d)(2).</DELETED>
        <DELETED>    ``(2) Minimum standards for certification of 
        approved bodies.--Not later than 24 months after the date of 
        enactment of this section, the Secretary shall establish the 
        standards regarding approved bodies referred to in subsection 
        (d)(2) and begin certifying approved bodies under such 
        subsection.</DELETED>
        <DELETED>    ``(3) Regulations for delivery of or payment for 
        services.--Not later than 36 months after the date of enactment 
        of this section, the Secretary shall promulgate the regulations 
        described in subsection (h). The Secretary may withhold the 
        provision of Federal assistance as provided for in subsection 
        (h) beginning on the date that is 48 months after the date of 
        enactment of this section.</DELETED>
<DELETED>    ``(k) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Approved body.--The term `approved body' 
        means an entity that has been certified by the Secretary under 
        subsection (d)(1) to accredit the various mechanisms by which 
        an individual can demonstrate compliance with the standards 
        promulgated under subsection (a) with respect to performing, 
        planning, evaluating, or verifying patient dose for medical 
        imaging or radiation therapy.</DELETED>
        <DELETED>    ``(2) Medical imaging.--The term `medical imaging' 
        means any procedure used to visualize tissues, organs, or 
        physiologic processes in humans for the purpose of diagnosing 
        illness or following the progression of disease. Images may be 
        produced utilizing ionizing radiation, radiopharmaceuticals, 
        magnetic resonance, or ultrasound and image production may 
        include the use of contrast media or computer processing. For 
        purposes of this section, such term does not include routine 
        dental diagnostic procedures.</DELETED>
        <DELETED>    ``(3) Perform.--The term `perform', with respect 
        to medical imaging or radiation therapy, means--</DELETED>
                <DELETED>    ``(A) the act of directly exposing a 
                patient to radiation via ionizing or radio frequency 
                radiation, to ultrasound, or to a magnetic field for 
                purposes of medical imaging or for purposes of 
                radiation therapy; and</DELETED>
                <DELETED>    ``(B) the act of positioning a patient to 
                receive such an exposure.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 4. REPORT ON THE EFFECTS OF THIS ACT.</DELETED>

<DELETED>    (a) Not later than 5 years after the date of 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 and the Committee on Energy and Commerce of the House of 
Representatives a report on the effects of this Act. Such report shall 
include the types and numbers of providers 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.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Consumer Assurance of Radiologic 
Excellence Act of 2006''.

SEC. 2. PURPOSE.

    The purpose of this Act is to improve the quality and value of 
healthcare by increasing the safety and accuracy of medical imaging 
examinations and radiation therapy treatments, 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) Establishment of Standards.--
            ``(1) In general.--The Secretary, in consultation with 
        recognized experts in the technical provision of medical 
        imaging and radiation therapy services, shall establish 
        standards to ensure the safety and accuracy of medical imaging 
        studies and radiation therapy treatments. Such standards shall 
        pertain to the personnel who perform, plan, evaluate, or verify 
        patient dose for medical imaging studies and radiation therapy 
        procedures and not to the equipment used.
            ``(2) Experts.--The Secretary shall select expert advisers 
        under paragraph (1) 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) Limitation.--The Secretary shall not take any action 
        under this subsection that would require licensure by a State 
        of those who provide the technical services referred to in this 
        subsection.
    ``(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.--
            ``(1) In general.--Under the standards established under 
        subsection (a), the Secretary shall ensure that individuals, 
        prior to performing or planning medical imaging and radiation 
        therapy services, demonstrate compliance with the standards 
        established under subsection (a) through successful completion 
        of certification by a professional organization, licensure, 
        completion of an examination, pertinent coursework or degree 
        program, verified pertinent experience, or through other ways 
        determined appropriate by the Secretary, or through some 
        combination thereof.
            ``(2) Miscellaneous provisions.--The standards established 
        under subsection (a)--
                    ``(A) may vary from discipline to discipline, 
                reflecting the unique and specialized nature of the 
                technical services provided, and shall represent expert 
                consensus as to what constitutes excellence in practice 
                and be appropriate to the particular scope of care 
                involved;
                    ``(B) may vary in form for each of the covered 
                disciplines; and
                    ``(C) may exempt individual providers from meeting 
                certain standards based on their scope of practice.
            ``(3) Recognition of individuals with extensive practical 
        experience.--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, or of an individual who 
        is regularly eligible to take the licensure or certification 
        examination for that discipline.
    ``(d) Approved Bodies.--
            ``(1) In general.--Not later than the date described in 
        subsection (j)(2), the Secretary shall begin to certify 
        qualified entities as approved bodies with respect to the 
        accreditation of the various mechanisms by which an individual 
        can demonstrate compliance with the standards promulgated under 
        subsection (a), 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 certification or for undertaking 
        examinations, and standards to minimize the possibility of 
        conflicts of interest), 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) be a nonprofit organization;
                    ``(B) comply with the standards described in 
                paragraph (2);
                    ``(C) notify the Secretary in a timely manner if 
                the body fails to comply with the standards described 
                in paragraph (2); and
                    ``(D) 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.--The withdrawal of the 
                certification of an approved body under subparagraph 
                (A) shall have no effect on the certification status of 
                any individual or person that was certified by that 
                approved body prior to the date of such withdrawal.
    ``(e) Existing State Standards.--Standards established by a State 
for the licensure or certification of personnel, accreditation of 
educational programs, or administration of examinations shall be deemed 
to be in compliance with the standards 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. The Secretary shall establish a process by 
which a State may respond to or appeal a determination made by the 
Secretary under the preceding sentence.
    ``(f) Rule of Construction.--Nothing in this section shall be 
construed to prohibit a State or other approved body from requiring 
compliance with a higher standard of education and training than that 
specified by this section. Notwithstanding any other provision of this 
section, individuals who provide medical imaging services relating to 
mammograms shall continue to meet the standards applicable under the 
Mammography Quality Standards Act of 1992.
    ``(g) 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).
    ``(h) Delivery of and Payment for Services.--Not later than the 
date described in subsection (j)(3), the Secretary shall promulgate 
regulations to ensure that all programs under the authority of the 
Secretary that involve the performance of or payment for medical 
imaging or radiation therapy, are performed in accordance with the 
standards established under this section.
    ``(i) 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 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' 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, 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.
    ``(j) Applicable Timelines.--
            ``(1) General implementation 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 all standards in this section except those 
        provided for in subsection (d)(2).
            ``(2) Minimum standards for certification of approved 
        bodies.--Not later than 24 months after the date of enactment 
        of this section, the Secretary shall establish the standards 
        regarding approved bodies referred to in subsection (d)(2) and 
        begin certifying approved bodies under such subsection.
            ``(3) Regulations for delivery of or payment for 
        services.--Not later than 36 months after the date of enactment 
        of this section, the Secretary shall promulgate the regulations 
        described in subsection (h). The Secretary may withhold the 
        provision of Federal assistance as provided for in subsection 
        (h) beginning on the date that is 48 months after the date of 
        enactment of this section.
    ``(k) Definitions.--In this section:
            ``(1) Approved body.--The term `approved body' means an 
        entity that has been certified by the Secretary under 
        subsection (d)(1) to accredit the various mechanisms by which 
        an individual can demonstrate compliance with the standards 
        promulgated under subsection (a) with respect to performing, 
        planning, evaluating, or verifying patient dose for medical 
        imaging or radiation therapy.
            ``(2) Medical imaging.--The term `medical imaging' means 
        any procedure used to visualize tissues, organs, or physiologic 
        processes in humans for the purpose of diagnosing illness or 
        following the progression of disease. Images may be produced 
        utilizing ionizing radiation, radiopharmaceuticals, magnetic 
        resonance, or ultrasound and image production may include the 
        use of contrast media or computer processing. For purposes of 
        this section, such term does not include routine dental 
        diagnostic 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, 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.
            ``(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.
    ``(l) Sunset.--This section shall have no force or effect after 
September 30, 2016.''.

SEC. 4. REPORT ON THE EFFECTS OF THIS ACT.

    (a) Not later than 5 years after the date of 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 and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the effects of this Act. Such report shall include the types 
and numbers of providers 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.
                                                       Calendar No. 668

109th CONGRESS

  2d Session

                                S. 2322

                          [Report No. 109-363]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                            December 5, 2006

                       Reported with an amendment