I 
110TH CONGRESS 
1ST SESSION 
H. R. 583 
To amend the Public Health Service Act to make the provision of technical 
services for medical imaging examinations and radiation therapy treat-
ments safer, more accurate, and less costly. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 19, 2007 
Mr. DOYLE (for himself, Mr. PICKERING, Mrs. CAPPS, Mr. DUNCAN, Mrs. 
BLACKBURN, Mr. ROGERS of Michigan, and Mrs. WILSON of New Mex-
ico) introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to make the provi-
sion of technical services for medical imaging examina-
tions and radiation therapy treatments safer, more accu-
rate, and less costly. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Consistency, Accuracy, 
Responsibility, and Excellence in Medical Imaging and 
Radiation Therapy Act of 2007’’. 
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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 consulta-
tion with recognized experts in the technical provi-
sion of medical imaging and radiation therapy serv-
ices, shall establish standards to ensure the safety 
and accuracy of medical imaging studies and radi-
ation therapy treatments. Such standards shall per-
tain to the personnel who perform, plan, evaluate, or 
verify patient dose for medical imaging studies and 
radiation therapy procedures and not to the equip-
ment used. 
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‘‘(2) EXPERTS.—The Secretary shall select ex-
pert 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 sin-
gle sector of practice on the content of such stand-
ards. 
‘‘(3) LIMITATION.—The Secretary shall not 
take any action under this subsection that would re-
quire 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 de-
fined in section 1861(r) of the Social Security Act (42 
U.S.C. 1395x(r))), nurse practitioners and physician as-
sistants (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 estab-
lished under subsection (a), the Secretary shall en-
sure that individuals, prior to performing or plan-
ning medical imaging and radiation therapy services, 
demonstrate compliance with the standards estab-
lished under subsection (a) through successful com-
pletion of certification by a professional organiza-
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tion, licensure, completion of an examination, perti-
nent coursework or degree program, verified perti-
nent experience, or through other ways determined 
appropriate by the Secretary, or through some com-
bination 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 rep-
resent 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 cov-
ered disciplines; and 
‘‘(C) may exempt individual providers from 
meeting certain standards based on their scope 
of practice. 
‘‘(3) RECOGNITION OF INDIVIDUALS WITH EX-
TENSIVE 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 
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of an individual who is regularly eligible to take the 
licensure or certification examination for that dis-
cipline. 
‘‘(d) APPROVED BODIES.— 
‘‘(1) IN GENERAL.—Not later than the date de-
scribed in subsection (j)(2), the Secretary shall begin 
to certify qualified entities as approved bodies with 
respect to the accreditation of the various mecha-
nisms by which an individual can demonstrate com-
pliance with the standards promulgated under sub-
section (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 estab-
lish minimum standards for the certification of ap-
proved bodies under paragraph (1) (including stand-
ards for recordkeeping, the approval of curricula and 
instructors, the charging of reasonable fees for cer-
tification or for undertaking examinations, and 
standards to minimize the possibility of conflicts of 
interest), and other additional standards as the Sec-
retary may require. 
‘‘(3) ASSURANCES.—To be certified as an ap-
proved body under paragraph (1), an organization or 
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agency shall provide the Secretary satisfactory as-
surances 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 man-
ner if the body fails to comply with the stand-
ards 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 ef-
fect 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 es-
tablished by a State for the licensure or certification of 
personnel, accreditation of educational programs, or ad-
ministration of examinations shall be deemed to be in com-
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pliance with the standards of this section unless the Sec-
retary 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 Sec-
retary shall establish a process by which a State may re-
spond to or appeal a determination made by the Secretary 
under the preceding sentence. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to prohibit a State or other ap-
proved 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 stand-
ards applicable under the Mammography Quality Stand-
ards Act of 1992. 
‘‘(g) EVALUATION
AND REPORT.—The Secretary 
shall periodically evaluate the performance of each ap-
proved body under subsection (d) at an interval deter-
mined appropriate by the Secretary. The results of such 
evaluations shall be included as part of the report sub-
mitted 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 accord-
ance with 354(e)(6)(B). 
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‘‘(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 ra-
diation therapy, are performed in accordance with the 
standards established under this section. 
‘‘(i) ALTERNATIVE STANDARDS FOR RURAL AND UN-
DERSERVED AREAS.— 
‘‘(1) IN GENERAL.—The Secretary shall deter-
mine whether the standards established under sub-
section (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 profes-
sional 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 Sec-
retary 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 de-
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veloped under paragraph (1) is inappropriate for ap-
plication to such State, and such alternative stand-
ard 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
REGULA-
TIONS.—Not later than 18 months after the date of 
enactment of this section, the Secretary shall pro-
mulgate such regulations as may be necessary to im-
plement 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 Sec-
retary shall establish the standards regarding ap-
proved bodies referred to in subsection (d)(2) and 
begin certifying approved bodies under such sub-
section. 
‘‘(3) REGULATIONS FOR DELIVERY OF OR PAY-
MENT FOR SERVICES.—Not later than 36 months 
after the date of enactment of this section, the Sec-
retary shall promulgate the regulations described in 
subsection (h). The Secretary may withhold the pro-
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vision of Federal assistance as provided for in sub-
section (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 dem-
onstrate 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 tis-
sues, organs, or physiologic processes in humans for 
the purpose of diagnosing illness or following the 
progression of disease. Images may be produced uti-
lizing ionizing radiation, radiopharmaceuticals, mag-
netic 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 proce-
dures. 
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‘‘(3) PERFORM.—The term ‘perform’, with re-
spect to medical imaging or radiation therapy, 
means— 
‘‘(A) the act of directly exposing a patient 
to radiation via ionizing or radio frequency ra-
diation, 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 re-
ceive 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 proce-
dure to a patient by evaluating site-specific informa-
tion, based on measurement and verification of radi-
ation dose distribution, computer analysis, or direct 
measurement of dose, in order to customize the pro-
cedure for the patient. 
‘‘(5) RADIATION
THERAPY.—The term ‘radi-
ation therapy’ means any procedure or article in-
tended for use in the cure, mitigation, treatment, or 
prevention of disease in humans that achieves its in-
tended purpose through the emission of radiation. 
‘‘(l) SUNSET.—This section shall have no force or ef-
fect after September 30, 2016.’’. 
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SEC. 4. REPORT ON THE EFFECTS OF THIS ACT. 
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 reim-
bursed 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. 
Æ 
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