I 

111TH CONGRESS 

1ST SESSION H. R. 3652 

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. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 25, 2009 

Mr. BARROW introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Ways and Means, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Consistency, Accuracy, 

5 Responsibility, and Excellence in Medical Imaging and 

6 Radiation Therapy Act of 2009’’. 


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1 SEC. 2. PURPOSE. 

2 The purpose of this Act is to improve the quality and 

3 value of health care by increasing the safety and accuracy 

4 of medical imaging examinations and radiation therapy 

5 procedures, thereby reducing duplication of services and 

6 decreasing costs. 

7 SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION 

8 THERAPY. 

9 Part F of title III of the Public Health Service Act 

10 (42 U.S.C. 262 et seq.) is amended by adding at the end 

11 the following: 

12 ‘‘Subpart 4—Medical Imaging and Radiation Therapy 

13 ‘‘SEC. 355. QUALITY OF MEDICAL IMAGING AND RADIATION 

14 THERAPY. 

15 ‘‘(a) QUALIFIED PERSONNEL.— 

16 ‘‘(1) IN GENERAL.—Effective January 1, 2013, 

17 personnel who perform or plan the technical compo18 nent of either medical imaging examinations or radi19 ation therapy procedures for medical purposes must 

20 be qualified under this section to perform or plan 

21 such services. 

22 ‘‘(2) QUALIFICATION.—Individuals qualified to 

23 perform or plan the technical component of medical 

24 imaging examinations or radiation therapy proce25 dures must— 


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1 ‘‘(A) possess current certification in each 

2 medical imaging or radiation therapy modality 

3 and service provided from a certification organi4 zation designated by the Secretary pursuant to 

5 subsection (c); or 

6 ‘‘(B) possess current State licensure, or 

7 certification, where— 

8 ‘‘(i) such services and modalities are 

9 within the scope of practice as defined by 

10 the State for such profession; and 

11 ‘‘(ii) the requirements for licensure, 

12 certification, or registration meet or exceed 

13 the standards established by the Secretary 

14 pursuant to this section. 

15 ‘‘(3) STATE LICENSURE, CERTIFICATION, OR

16 REGISTRATION.— 

17 ‘‘(A) Nothing in this section diminishes the 

18 authority of a State to define requirements for 

19 licensure, certification, or registration, the re20 quirements for practice, or the scope of practice 

21 of personnel. 

22 ‘‘(B) The Secretary shall not take any ac23 tion under this section that would require licen24 sure by a State of those who perform or plan 


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1 the technical component of medical imaging ex2 aminations or radiation therapy procedures. 

3 ‘‘(4) EXEMPTIONS.—The qualification stand4 ards described in this subsection shall not apply to 

5 physicians (as defined in section 1861(r) of the So6 cial Security Act (42 U.S.C. 1395x(r))) or to nurse 

7 practitioners and physician assistants (each as de8 fined in section 1861(aa)(5) of the Social Security 

9 Act (42 U.S.C. 1395x(aa)(5))). 

10 ‘‘(b) ESTABLISHMENT OF STANDARDS.— 

11 ‘‘(1) IN GENERAL.—For the purposes of deter12 mining compliance with subsection (a), the Sec13 retary, in consultation with recognized experts in the 

14 technical provision of medical imaging or radiation 

15 therapy services, shall establish minimum standards 

16 for personnel who perform, plan, evaluate, or verify 

17 patient dose for medical imaging examinations or ra18 diation therapy procedures. Such standards shall not 

19 apply to the equipment used. 

20 ‘‘(2) EXPERTS.—For the purposes of this sub21 section, the Secretary shall select expert advisers to 

22 reflect a broad and balanced input from all sectors 

23 of the health care community that are involved in 

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1 ence from any single sector of practice on the con2 tent of such standards. 

3 ‘‘(3) MINIMUM STANDARDS.—Minimum stand4 ards may vary in form for each of the covered dis5 ciplines, reflecting the unique or specialized nature 

6 of the technical services provided, and shall rep7 resent expert consensus from those practicing in 

8 each of the covered disciplines as to what constitutes 

9 excellence in practice and be appropriate to the par10 ticular scope of care involved. 

11 ‘‘(4) ALLOWANCE FOR ADDITIONAL STAND12 ARDS.—Nothing in this subsection shall be con13 strued to prohibit a State or certification organiza14 tion from requiring compliance with higher stand15 ards than the minimum standards specified by the 

16 Secretary pursuant to this subsection. 

17 ‘‘(5) TIMELINE.—The Secretary shall promul18 gate regulations for the purposes of carrying out this 

19 subsection no later than 18 months after the date on 

20 which this section is enacted. 

21 ‘‘(c) DESIGNATION OF CERTIFICATION ORGANIZA22 TIONS.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall estab24 lish a program for designating certification organiza25 tions that the Secretary determines have established 


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1 appropriate procedures and programs for certifying 

2 personnel as qualified to furnish medical imaging or 

3 radiation therapy services. 

4 ‘‘(2) FACTORS.—When designating certification 

5 organizations, and when reviewing or modifying the 

6 list of designated organizations for the purposes of 

7 paragraph (4)(B), the Secretary shall consider— 

8 ‘‘(A) whether the certification organization 

9 has established certification requirements for 

10 individuals that are consistent with or exceed 

11 the minimum standards established in sub12 section (b); 

13 ‘‘(B) whether the certification organization 

14 has established a process for the timely integra15 tion of new medical imaging or radiation ther16 apy services into the organization’s certification 

17 program; 

18 ‘‘(C) whether the certification organization 

19 has established education and continuing edu20 cation requirements for individuals certified by 

21 the organization; 

22 ‘‘(D) whether the organization has estab23 lished reasonable fees to be charged to those 

24 applying for certification; 


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1 ‘‘(E) whether the examinations leading to 

2 certification by the certification organization 

3 are accredited by an appropriate accrediting 

4 body as defined in subsection (d); 

5 ‘‘(F) the ability of the certification organi6 zation to review applications for certification in 

7 a timely manner; and 

8 ‘‘(G) such other factors as the Secretary 

9 determines appropriate. 

10 ‘‘(3) EQUIVALENT EDUCATION, TRAINING, AND

11 EXPERIENCE.— 

12 ‘‘(A) IN GENERAL.—For purposes of this 

13 section, the Secretary shall, through regulation, 

14 provide a method for the recognition of individ15 uals whose training or experience are deter16 mined to be equal to, or in excess of, those of 

17 a graduate of an accredited educational pro18 gram in that specialty. Such authority shall ex19 pire seven years after the enactment of this sec20 tion. 

21 ‘‘(B) ELIGIBILITY.—The Secretary shall 

22 not recognize any individual pursuant to the au23 thority of subparagraph (A) unless such indi24 vidual— 


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1 ‘‘(i) was performing or planning the 

2 technical component of medical imaging 

3 examinations or radiation therapy treat4 ments prior to enactment of this section; 

5 and 

6 ‘‘(ii) is ineligible to take the licensure 

7 or certification examination for that dis8 cipline. 

9 ‘‘(4) PROCESS.— 

10 ‘‘(A) REGULATIONS.—The Secretary shall, 

11 by July 1, 2012, promulgate regulations for 

12 designating certification organizations pursuant 

13 to this paragraph. 

14 ‘‘(B) DESIGNATIONS AND LIST.—The Sec15 retary shall, by January 1, 2013, make deter16 minations regarding all certification organiza17 tions that have applied for designation pursuant 

18 to the regulations promulgated under subpara19 graph (A), and shall publish a list of all certifi20 cation organizations that have received designa21 tion. 

22 ‘‘(C) PERIODIC REVIEW AND REVISION.— 

23 The Secretary shall periodically review the list, 

24 taking into account the factors established 

25 under paragraph (2). After such review, the 


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1 Secretary may, by regulation, modify the list of 

2 certification organizations that have received 

3 designation. 

4 ‘‘(D) CERTIFICATIONS PRIOR TO REMOVAL

5 FROM LIST.—If the Secretary removes a certifi6 cation organization from the list of certification 

7 organizations designated under subparagraph 

8 (B), any individual who was certified by the 

9 certification organization during or before the 

10 period beginning on the date on which the cer11 tification organization was designated as a cer12 tification organization under subparagraph (B) 

13 and ending on the date on which the certifi14 cation organization is removed from such list 

15 shall be considered to have been certified by a 

16 certification organization designated by the Sec17 retary under subparagraph (B) for the remain18 ing period that such certification is in effect. 

19 ‘‘(d) APPROVED ACCREDITING BODIES.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall publish 

21 a list of entities that are approved accrediting bodies 

22 for certification organizations for purposes of sub23 section (c)(2)(E). The Secretary shall publish the 

24 list no later than 24 months after enactment of this 

25 section and shall revise the list as appropriate. 


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1 ‘‘(2) REQUIREMENTS FOR APPROVAL.—The 

2 Secretary shall not approve an accrediting body for 

3 certification organizations unless the Secretary de4 termines that such accrediting body— 

5 ‘‘(A) is a nonprofit organization; 

6 ‘‘(B) is a national or international organi7 zation with accreditation programs for examina8 tions leading to certification by certification or9 ganizations; 

10 ‘‘(C) has established standards for record11 keeping and to minimize the possibility of con12 flicts of interest; and 

13 ‘‘(D) demonstrates compliance with any 

14 other requirements established by the Sec15 retary. 

16 ‘‘(3) WITHDRAWAL OF APPROVAL.—The Sec17 retary may withdraw the approval of an accrediting 

18 body if the Secretary determines that the body does 

19 not meet the standards defined in paragraph (2). 

20 ‘‘(e) ALTERNATIVE STANDARDS FOR RURAL AND

21 UNDERSERVED AREAS.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall deter23 mine whether the standards established under sub24 section (a) must be met in their entirety for medical 

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1 dures that are performed and planned in a geo2 graphic area that is determined by the Medicare Ge3 ographic Classification Review Board to be a ‘rural 

4 area’ or that is designated as a health professional 

5 shortage area. If the Secretary determines that al6 ternative standards for such rural areas or health 

7 professional shortage areas are appropriate to assure 

8 access to quality medical imaging examinations or 

9 radiation therapy procedures, the Secretary is au10 thorized to develop such alternative standards. 

11 ‘‘(2) STATE DISCRETION.—The chief executive 

12 officer of a State may submit to the Secretary a 

13 statement declaring that an alternative standard de14 veloped under paragraph (1) is inappropriate for ap15 plication to such State, and such alternative stand16 ard shall not apply in such submitting State. The 

17 chief executive officer of a State may rescind a 

18 statement described in this paragraph following the 

19 provision of appropriate notice to the Secretary. 

20 ‘‘(f) RULE OF CONSTRUCTION.—Notwithstanding 

21 any other provision of this section, individuals who provide 

22 medical imaging examinations relating to mammograms 

23 shall continue to meet the regulations applicable under the 

24 Mammography Quality Standards Act of 1992, as amend25 ed. 


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1 ‘‘(g) DEFINITIONS.—As used in this section— 

2 ‘‘(1) MEDICAL IMAGING.—The term ‘medical 

3 imaging’ means any examination or procedure used 

4 to visualize tissues, organs, or physiologic processes 

5 in humans for the purpose of detecting, diagnosing, 

6 treating or impacting the progression of disease or 

7 illness. For purposes of this section, such term does 

8 not include routine dental diagnostic procedures or 

9 advanced imaging procedures as defined in section 

10 1834(e)(1)(B) of the Social Security Act. 

11 ‘‘(2) PERFORM.—The term ‘perform’, with re12 spect to medical imaging or radiation therapy, 

13 means— 

14 ‘‘(A) the act of directly exposing a patient 

15 to radiation including ionizing or radio fre16 quency radiation, to ultrasound, or to a mag17 netic field for purposes of medical imaging or 

18 for purposes of radiation therapy; and 

19 ‘‘(B) the act of positioning a patient to re20 ceive such an exposure. 

21 ‘‘(3) PLAN.—The term ‘plan’, with respect to 

22 medical imaging or radiation therapy, means the act 

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1 ation dose distribution, computer analysis, or direct 

2 measurement of dose, in order to customize the pro3 cedure for the patient. 

4 ‘‘(4) RADIATION THERAPY.—The term ‘radi5 ation therapy’ means any procedure or article in6 tended for use in the cure, mitigation, treatment, or 

7 prevention of disease in humans that achieves its in8 tended purpose through the emission of ionizing or 

9 non-ionizing radiation.’’. 

10 SEC. 4. PAYMENT AND STANDARDS FOR MEDICAL IMAGING 

11 AND RADIATION THERAPY. 

12 Section 1848(b)(4) of the Social Security Act (42 

13 U.S.C. 1395w–4(b)(4)) is amended— 

14 (1) in subparagraph (A), by striking the ‘‘imag15 ing’’ and inserting ‘‘medical imaging and radiation 

16 therapy’’ and; 

17 (2) by adding at the end the following new sub18 paragraph: 

19 ‘‘(C) PAYMENT FOR MEDICAL IMAGING

20 AND RADIATION THERAPY SERVICES.—With re21 spect to expenses incurred for the planning and 

22 performing of the technical component of med23 ical imaging examinations or radiation therapy 

24 procedures furnished on or after January 1, 

25 2013, payment shall be made under this section 


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1 only if the examination or procedure is planned 

2 or performed by an individual who meets the 

3 requirements established by the Secretary under 

4 section 355 of the Public Health Service Act.’’. 

5 SEC. 5. REPORT ON THE EFFECTS OF THIS ACT. 

6 (a) IN GENERAL.—The Secretary of Health and 

7 Human Services, acting through the Director of the Agen8 cy for Healthcare Research and Quality, shall submit to 

9 the Committee on Health, Education, Labor, and Pen10 sions of the Senate, the Committee on Finance of the Sen11 ate, and the Committee on Energy and Commerce of the 

12 House of Representatives, a report on the effects of this 

13 Act no later than 5 years after the date of the enactment 

14 of this Act. 

15 (b) REQUIREMENTS.—Such report shall include the 

16 types and numbers of individuals qualified to perform or 

17 plan the technical component of medical imaging or radi18 ation therapy services for whom standards have been de19 veloped, the impact of such standards on diagnostic accu20 racy and patient safety, and the availability and cost of 

21 services. Entities reimbursed for technical services 

22 through programs operating under the authority of the 

23 Secretary of Health and Human Services shall be required 

24 to contribute data to such report. 

Æ 


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