[Congressional Record (Bound Edition), Volume 152 (2006), Part 17]
[Senate]
[Pages 22800-22803]
[From the U.S. Government Publishing Office, www.gpo.gov]




        CONSUMER ASSURANCE OF RADIOLOGIC EXCELLENCE ACT OF 2006

  Mr. FRIST. Mr. President, I ask unanimous consent the Senate proceed 
to the immediate consideration of Calendar No. 668, S. 2322.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 2322) 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.

  There being no objection, the Senate proceed to consider the bill 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

                                S. 2322

       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 ``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.

[[Page 22801]]



     [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.
       [``(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.
       [``(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.--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.
       [``(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,

[[Page 22802]]

     treatment, or prevention of disease in humans that achieves 
     its intended purpose through the emission of radiation.''.

     [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.]

     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

[[Page 22803]]

     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.

  Mr. FRIST. I ask unanimous consent the committee-reported amendment 
be agreed to, the bill as amended be read a third time and passed, the 
motion to reconsider be laid on the table, and any statements be 
printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee amendment in the nature of a substitute was agreed to.
  The bill (S. 2322) was ordered to be engrossed for a third reading, 
was read the third time, and passed.

                          ____________________