I 
112TH CONGRESS 
1ST SESSION H. R. 2104 
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 accu-
rate, and less costly. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 2, 2011 
Mr. WHITFIELD (for himself, Mr. BARROW, Mr. BOSWELL, Mr. COHEN, Mr. 
CONNOLLY of Virginia, Mr. DUNCAN of Tennessee, Mr. GUTHRIE, Mr. 
HALL, Mr. HARPER, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. 
JONES, Mr. KILDEE, Mr. KIND, Mr. LANCE, Mr. HEINRICH, Mr. MCIN-
TYRE, Mrs. MYRICK, Ms. RICHARDSON, and Mr. RUSH) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Consistency, Accuracy, 
Responsibility, and Excellence in Medical Imaging and 
Radiation Therapy Act of 2011’’. 
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, 2014, 
personnel who perform or plan the technical compo-
nent of either medical imaging examinations or radi-
ation therapy procedures for medical purposes shall 
be qualified under this section to perform or plan 
such services. 
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‘‘(2) QUALIFICATIONS.—Individuals qualified to 
perform or plan the technical component of medical 
imaging examinations or radiation therapy proce-
dures shall— 
‘‘(A) possess current certification in the 
medical imaging or radiation therapy modality 
or service they plan or perform from a certifi-
cation 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) IN GENERAL.—Nothing in this sec-
tion shall be construed to diminish the author-
ity of a State to define requirements for licen-
sure, certification, or registration, the require-
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ments for practice, or the scope of practice of 
personnel. 
‘‘(B) LIMITATION.—The Secretary shall 
not take any action under this section that 
would require licensure by a State of personnel 
who perform or plan the technical component of 
medical imaging examinations or radiation ther-
apy procedures. 
‘‘(4) EXEMPTIONS.—The qualification stand-
ards described in this subsection and the payment 
provisions in section 1848(b)(4)(C) of the Social Se-
curity Act 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 phy-
sician assistants (each as defined in section 
1861(aa)(5) of the Social Security Act (42 U.S.C. 
1395x(aa)(5))). Such practitioners shall not be in-
cluded under the terms ‘personnel’ or ‘qualified per-
sonnel’ for purposes of this section. 
‘‘(b) ESTABLISHMENT OF STANDARDS.— 
‘‘(1) IN GENERAL.—For the purposes of deter-
mining compliance with subsection (a), the Sec-
retary, in consultation with recognized experts in the 
technical provision of medical imaging or radiation 
therapy services, shall establish minimum standards 
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for personnel who perform, plan, evaluate, or verify 
patient dose for medical imaging examinations or ra-
diation therapy procedures. Such standards shall not 
apply to the equipment used. 
‘‘(2) RECOGNIZED EXPERTS.— 
‘‘(A) IN GENERAL.—For the purposes of 
this subsection, the Secretary shall select recog-
nized expert advisers to reflect a broad and bal-
anced input from all sectors of the health care 
community that are involved in the provision of 
services of the type described in paragraph (1) 
to avoid undue influence from any single sector 
of practice relating to the content of such 
standards. 
‘‘(B) DEFINITION.—In this paragraph, the 
term ‘recognized experts’ includes— 
‘‘(i) representatives of all medical spe-
cialties and providers that perform or plan 
medical imaging procedures; 
‘‘(ii) representatives of all medical 
specialties and providers that perform or 
plan radiation therapy procedures; 
‘‘(iii) medical imaging and radiation 
therapy technology experts; and 
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‘‘(iv) other experts determined appro-
priate by the Secretary. 
‘‘(3) MINIMUM STANDARDS.—Minimum stand-
ards established under this subsection shall reflect 
the unique or specialized nature of the technical 
services provided, and shall represent expert con-
sensus from those practicing in each of the covered 
imaging modalities and radiation therapy procedures 
as to what constitutes excellence in practice and be 
appropriate to the particular scope of care involved. 
‘‘(4) ALLOWANCE
FOR
ADDITIONAL
STAND-
ARDS.—Nothing in this subsection shall be con-
strued to prohibit a State or certification organiza-
tion from requiring compliance with standards that 
exceed the minimum standards specified by the Sec-
retary pursuant to this subsection. 
‘‘(5) TIMELINE.—Not later than 12 months 
after the date of enactment of this section, the Sec-
retary shall promulgate regulations for the purposes 
of carrying out this subsection. 
‘‘(c) DESIGNATION
OF CERTIFICATION ORGANIZA-
TIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a program for designating certification organiza-
tions that the Secretary determines have established 
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appropriate procedures and programs for certifying 
personnel as qualified to furnish medical imaging or 
radiation therapy services. 
‘‘(2) FACTORS.—When designating certification 
organizations under this subsection, and when re-
viewing or modifying the list of designated organiza-
tions for the purposes of paragraph (4)(B), the Sec-
retary shall consider— 
‘‘(A) whether the certification organization 
has established certification requirements for 
individuals that are consistent with or exceed 
the minimum standards established in sub-
section (b); 
‘‘(B) whether the certification organization 
has established a process for the timely integra-
tion of new medical imaging or radiation ther-
apy services into the organization’s certification 
program; 
‘‘(C) whether the certification organization 
has established education and continuing edu-
cation requirements for individuals certified by 
the organization; 
‘‘(D) whether the organization has estab-
lished reasonable fees to be charged to those 
applying for certification; 
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‘‘(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 organi-
zation 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 process for individuals whose training 
or experience are determined to be equal to, or 
in excess of, those of a graduate of an accred-
ited educational program in that specialty to 
demonstrate their experience meets the edu-
cational standards for qualified personnel in 
their imaging modality or radiation therapy 
procedures. Such process may include docu-
mentation of items such as— 
‘‘(i) years and type of experience; 
‘‘(ii) a list of settings where experi-
ence was obtained; and 
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‘‘(iii) verification of experience by su-
pervising physicians or clinically qualified 
hospital personnel. 
‘‘(B) ELIGIBILITY.—The Secretary shall 
not recognize any individual as having met the 
educational standards applicable under this 
paragraph based on experience pursuant to the 
authority of subparagraph (A) unless such indi-
vidual was performing or planning the technical 
component of medical imaging examinations or 
radiation therapy treatments prior to the date 
of enactment of this section. 
‘‘(C) 
CERTIFICATION
TEST
REQUIRE-
MENT.—To be eligible to be certified under this 
subsection an individual shall, not later than 18 
months after the date on which the list of des-
ignated certification organizations is published 
under paragraph (4), successfully complete a 
certification examination administered by a des-
ignated certification organization. During such 
18-month period, the penalties provided for 
under section 1848(b)(4)(C) of the Social Secu-
rity Act (as added by section 4 of the Consist-
ency, Accuracy, Responsibility, and Excellence 
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in Medical Imaging and Radiation Therapy Act 
of 2011) shall not apply to such individuals. 
‘‘(4) PROCESS.— 
‘‘(A) REGULATIONS.—Not later than July 
1, 2013, the Secretary shall promulgate regula-
tions for designating certification organizations 
pursuant to this subsection. 
‘‘(B) DESIGNATIONS AND LIST.—Not later 
than January 1, 2014, the Secretary shall make 
determinations regarding all certification orga-
nizations that have applied for designation pur-
suant to the regulations promulgated under 
subparagraph (A), and shall publish a list of all 
certification organizations that have received a 
designation. 
‘‘(C) PERIODIC REVIEW AND REVISION.— 
The Secretary shall periodically review the list 
under subparagraph (B), taking into account 
the factors established under paragraph (2). 
After such review, the Secretary may, by regu-
lation, modify the list of certification organiza-
tions that have received such designation. 
‘‘(D) CERTIFICATIONS PRIOR TO REMOVAL 
FROM LIST.—If the Secretary removes a certifi-
cation organization from the list of certification 
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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 cer-
tification organization was designated as a cer-
tification organization under such subpara-
graph, and ending on the date on which the cer-
tification organization is removed from such 
list, shall be considered to have been certified 
by a certification organization designated by the 
Secretary under such subparagraph for the re-
maining period that such certification is in ef-
fect. 
‘‘(d) APPROVED ACCREDITING BODIES.— 
‘‘(1) IN GENERAL.—Not later than 24 months 
after the date of enactment of this section, the Sec-
retary shall publish a list of entities that are ap-
proved accrediting bodies for certification organiza-
tions for purposes of subsection (c)(2)(E). The Sec-
retary shall revise such list as appropriate. 
‘‘(2) REQUIREMENTS
FOR
APPROVAL.—The 
Secretary shall not approve an accrediting body for 
certification organizations under this subsection un-
less the Secretary determines that such accrediting 
body— 
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‘‘(A) is a nonprofit organization; 
‘‘(B) is a national or international organi-
zation with accreditation programs for examina-
tions leading to certification by certification or-
ganizations; 
‘‘(C) has established standards for record-
keeping and to minimize the possibility of con-
flicts of interest; and 
‘‘(D) demonstrates compliance with any 
other requirements established by the Sec-
retary. 
‘‘(3) WITHDRAWAL
OF
APPROVAL.—The Sec-
retary may withdraw the approval of an accrediting 
body under this paragraph if the Secretary deter-
mines that the body does not meet the requirements 
of paragraph (2). 
‘‘(e) ALTERNATIVE STANDARDS
FOR RURAL
AND 
UNDERSERVED 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 examinations or radiation therapy proce-
dures that are performed and planned in a geo-
graphic area that is determined by the Medicare Ge-
ographic Classification Review Board to be a ‘rural 
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area’ or that is designated as a health professional 
shortage area. If the Secretary determines that al-
ternative standards for such rural areas or health 
professional shortage areas are appropriate to en-
sure access to quality medical imaging examinations 
or radiation therapy procedures, the Secretary is au-
thorized 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-
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. 
‘‘(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 amend-
ed). 
‘‘(g) DEFINITION.—As used in this section: 
‘‘(1) MEDICAL
IMAGING.—The term ‘medical 
imaging’ means any examination or procedure used 
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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 or ophthalmologic diag-
nostic procedures or ultrasound guidance of vascular 
access procedures. 
‘‘(2) PERFORM.—The term ‘perform’, with re-
spect to medical imaging or radiation therapy, 
means— 
‘‘(A) the act of directly exposing a patient 
to radiation, including ionizing or radio fre-
quency radiation, to ultrasound, or to a mag-
netic 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. 
‘‘(3) 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 on 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. 
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‘‘(4) 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 ionizing or 
non-ionizing radiation.’’. 
SEC. 4. REQUIRED 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 by adding at the end 
the following new subparagraph: 
‘‘(E) REQUIRED STANDARDS FOR MEDICAL 
IMAGING
AND
RADIATION
THERAPY
SERV-
ICES.—With respect to expenses incurred for 
the planning and performing of the technical 
component of medical imaging examinations or 
radiation therapy procedures (as defined in sub-
section (g) of section 355 of the Public Health 
Service Act) furnished on or after January 1, 
2014, 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 
such section 355.’’. 
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SEC. 5. REPORT ON THE EFFECTS OF THIS ACT. 
(a) IN GENERAL.—Not later than 5 years after the 
date of the 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 Pen-
sions of the Senate, the Committee on Finance of the Sen-
ate, and the Committee on Energy and Commerce of the 
House of Representatives, a report on the effects of this 
Act. 
(b) REQUIREMENTS.—The report under subsection 
(a) 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 stand-
ards 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. 
Æ 
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