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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.

Passed the Senate December 6, 2006.

Attest:

EMILY J. REYNOLDS,

Secretary.
Output:
Consumer Assurance of Radiologic Excellence Act of 2006 - (Sec. 3) Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish standards to ensure the safety and accuracy of medical imaging studies and radiation therapy treatments. Imposes such standards on personnel who perform, plan, or evaluate, or verify patient doses for, medical imaging studies and radiation therapy procedures and not on the equipment used. Exempts physicians, nurse practitioners, and physician assistants.

Directs the Secretary to ensure that individuals demonstrate compliance through successful completion of certification by a professional organization, licensure, completion of an examination, pertinent coursework or degree program, or verified pertinent experience.

Allows the standards to: (1) vary from discipline to discipline, represent expert consensus as to what constitutes excellence in practice, and be appropriate to the particular scope of care involved; (2) vary in form for each of the covered disciplines; and (3) exempt individual providers from meeting certain standards based on their scope of practice.

Requires the Secretary to provide a method for the recognition of individuals whose training and experience are determined to equal or exceed that of: (1) a graduate of an accredited educational program in that specialty; or (2) an individual who is regularly eligible to take the licensure or certification examination for that discipline.

Directs the Secretary to certify bodies for accreditation of various mechanisms by which an individual can demonstrate compliance with the standards. Requires the Secretary to establish minimum standards for certification, including assurances that the body will: (1) be a nonprofit organization; (2) comply with the established standards; and (3) notify the Secretary in a timely manner if it fails to comply. Allows the Secretary to withdraw certification upon determining the body does not meet the required standards.

Deems state standards for licensure or certification of personnel, accreditation of educational programs, or administration of examinations to be in compliance with standards under this Act unless the Secretary determines they do not meet minimum standards or are inconsistent with this Act. Requires the Secretary to establish an appeal process.

Requires the Secretary to: (1) evaluate the performance of each approved body; (2) ensure that programs that involve the performance of or payment for medical imaging or radiation therapy meet such standards; and (3) determine whether such standards must be met in their entirety in rural areas. Authorizes the Secretary to develop alternative standards for rural areas or health professional shortage areas to assure access to quality medical imaging.

Sets forth a timeline for the implementation of the standards under this Act.

(Sec. 4) Sets forth reporting requirements.