II 

113TH CONGRESS 

1ST SESSION S. 642 

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 SENATE OF THE UNITED STATES 

MARCH 21, 2013 

Mr. ENZI introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

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 2013’’. 


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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 42 months after 

17 the date of enactment of this section, personnel who 

18 furnish the technical component of medical imaging 

19 examinations or radiation therapy procedures for 

20 medical purposes (except exempt individuals and 

21 suppliers as described in paragraph (4)) shall be 

22 fully qualified under this section to furnish such 

23 services. 

24 ‘‘(2) QUALIFICATIONS.—Individuals qualified to 

25 furnish the technical component of medical imaging 


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1 examinations or radiation therapy procedures 

2 shall— 

3 ‘‘(A) possess current certification in the 

4 medical imaging or radiation therapy modality 

5 or service they furnish from a certification or6 ganization designated under subsection (b); and 

7 ‘‘(B) if a State requires the possession of 

8 licensure, certification, or registration, possess 

9 current State licensure or certifications where 

10 such services and modalities are within the 

11 scope of practice as defined by the State for 

12 such profession. 

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

14 REGISTRATION.— 

15 ‘‘(A) IN GENERAL.—Nothing in this sec16 tion shall be construed to diminish the author17 ity of a State to define requirements for licen18 sure, certification, or registration, the require19 ments for practice, or the scope of practice of 

20 personnel. 

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

22 not take any action under this section that 

23 would require licensure by a State of personnel 

24 who furnish the technical component of medical 


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1 imaging examinations or radiation therapy pro2 cedures. 

3 ‘‘(4) EXEMPTIONS.— 

4 ‘‘(A) IN GENERAL.—The qualification 

5 standards described in this subsection and the 

6 limitation on payment in section 1848(b)(4)(E) 

7 of the Social Security Act (42 U.S.C. 1395w– 

8 4(b)(4)(E)) shall not apply to any of the fol9 lowing: 

10 ‘‘(i) Items and services furnished by a 

11 physician (as defined in section 1861(r) of 

12 such Act (42 U.S.C. 1395x(r))), a nurse 

13 practitioner or a physician assistant (each 

14 as defined in section 1861(aa)(5) of such 

15 Act (42 U.S.C. 1395x(aa)(5))). Such phy16 sicians and practitioners shall not be in17 cluded under the terms ‘personnel’ or 

18 ‘qualified personnel’ for purposes of this 

19 section. 

20 ‘‘(ii) Advanced diagnostic imaging 

21 services (as defined in paragraph (1)(B) of 

22 section 1834(e) of such Act) furnished by 

23 a supplier (as defined in paragraph (1)(C) 

24 of such Act) for which the accreditation re25 quirement under such section is applicable. 


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1 ‘‘(B) INDIVIDUALS CURRENTLY EN2 ROLLED.—Individuals enrolled in a nuclear 

3 medicine, radiation therapy, or medical physi4 cist training or certification program as of the 

5 date the Secretary publishes the list of ap6 proved certification organizations shall have 6 

7 months from the date of completion of the 

8 training program to become fully qualified as 

9 required under paragraph (1). 

10 ‘‘(b) DESIGNATION OF CERTIFICATION ORGANIZA11 TIONS.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall estab13 lish a program for designating medical imaging or 

14 radiation therapy certification organizations that the 

15 Secretary determines have established appropriate 

16 procedures and programs for certifying personnel as 

17 qualified to furnish medical imaging or radiation 

18 therapy services. In establishing such program, the 

19 Secretary shall consult with professional organiza20 tions and recognized experts in the technical compo21 nent of medical imaging and radiation therapy serv22 ices. 

23 ‘‘(2) FACTORS.— 

24 ‘‘(A) IN GENERAL.—When designating cer25 tification organizations under this subsection, 


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1 and when reviewing or modifying the list of des2 ignated organizations for the purposes of para3 graph (4)(B), the Secretary— 

4 ‘‘(i) shall consider— 

5 ‘‘(I) whether the certification or6 ganization has established a process 

7 for the timely integration of new med8 ical imaging or radiation therapy serv9 ices into the organization’s certifi10 cation program; 

11 ‘‘(II) whether the certification or12 ganization has established education 

13 and continuing education require14 ments for individuals certified by the 

15 organization; 

16 ‘‘(III) whether the certification 

17 organization is a nonprofit organiza18 tion; 

19 ‘‘(IV) whether the certification 

20 organization requires completion of a 

21 certification examination as a pre22 requisite for certification; and 

23 ‘‘(V) whether the certification or24 ganization has been accredited by an 

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1 paragraph (B)) that is approved by 

2 the Secretary; and 

3 ‘‘(ii) may consider— 

4 ‘‘(I) whether the certification or5 ganization has established reasonable 

6 fees to be charged to those applying 

7 for certification; and 

8 ‘‘(II) the ability of the certifi9 cation organization to review applica10 tions for certification in a timely man11 ner. 

12 ‘‘(B) ACCREDITING BODY.—For purposes 

13 of this section, the term ‘accrediting body’ 

14 means an organization that— 

15 ‘‘(i) is a nonprofit organization; 

16 ‘‘(ii) is a national or international or17 ganization with accreditation programs for 

18 examinations leading to certification by 

19 certification organizations; and 

20 ‘‘(iii) has established standards for 

21 recordkeeping and to minimize the possi22 bility of conflicts of interest. 

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

24 EXPERIENCE.— 


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

2 section, the Secretary shall, through regulation, 

3 provide a process for individuals whose training 

4 or experience are determined to be equal to, or 

5 in excess of, those of a graduate of an accred6 ited educational program in that specialty to 

7 demonstrate their experience meets the edu8 cational standards for qualified personnel in 

9 their imaging modality or radiation therapy 

10 procedures. Such process may include docu11 mentation of items such as— 

12 ‘‘(i) years and type of experience; 

13 ‘‘(ii) a list of settings where experi14 ence was obtained; and 

15 ‘‘(iii) verification of experience by su16 pervising physicians or clinically qualified 

17 hospital personnel. 

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

19 not recognize any individual as having met the 

20 educational standards applicable under this 

21 paragraph based on experience pursuant to the 

22 authority of subparagraph (A) unless such indi23 vidual was furnishing the technical component 

24 of medical imaging examinations or radiation 


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1 therapy treatments prior to the date of enact2 ment of this section. 

3 ‘‘(4) PROCESS.— 

4 ‘‘(A) REGULATIONS.—Not later than 12 

5 months after the date of enactment of this sec6 tion, the Secretary shall promulgate regulations 

7 for designating certification organizations pur8 suant to this subsection. 

9 ‘‘(B) DESIGNATIONS AND LIST.—Not later 

10 than 18 months after the date of enactment of 

11 this section, the Secretary shall make deter12 minations regarding all certification organiza13 tions that have applied for designation pursuant 

14 to the regulations promulgated under subpara15 graph (A), and shall publish a list of all certifi16 cation organizations that have received a des17 ignation. 

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

19 The Secretary shall periodically review the list 

20 under subparagraph (B), taking into account 

21 the factors under paragraph (2). After such re22 view, the Secretary may, by regulation, modify 

23 the list of certification organizations that have 

24 received such designation. 


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1 ‘‘(D) WITHDRAWAL OF APPROVAL.—The 

2 Secretary may withdraw the approval of a cer3 tification organization listed under subpara4 graph (B) if the Secretary determines that the 

5 body no longer meets the requirements of sub6 section (b). 

7 ‘‘(E) CERTIFICATIONS PRIOR TO REMOVAL

8 FROM LIST.—If the Secretary removes a certifi9 cation organization from the list of certification 

10 organizations designated under subparagraph 

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

12 certification organization during or before the 

13 period beginning on the date on which the cer14 tification organization was designated as a cer15 tification organization under such subpara16 graph, and ending 12 months from the date on 

17 which the certification organization is removed 

18 from such list, shall be considered to have been 

19 certified by a certification organization des20 ignated by the Secretary under such subpara21 graph for the remaining period that such cer22 tification is in effect. 

23 ‘‘(c) ALTERNATIVE STANDARDS FOR RURAL AND

24 UNDERSERVED AREAS.—The chief executive officer of a 

25 State may submit to the Secretary a statement declaring 


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1 that the requirements described in subsection (a) are inap2 propriate for application for medical imaging examinations 

3 or radiation therapy procedures that are furnished in a 

4 geographic area that is determined to be a ‘rural area’ 

5 (as such term is defined for purposes of section 

6 1886(d)(2)(D) of the Social Security Act) or that is des7 ignated as a health professional shortage area (as defined 

8 in section 332 of this Act). Upon receipt of such state9 ment, if the Secretary deems it appropriate, the Secretary 

10 may waive the standards described in subsection (a) or 

11 develop alternative standards for such rural areas or 

12 health professional shortage areas. 

13 ‘‘(d) RULE OF CONSTRUCTION.—Notwithstanding 

14 any other provision of this section, individuals who provide 

15 medical imaging examinations relating to mammograms 

16 shall continue to meet the regulations applicable under the 

17 Mammography Quality Standards Act of 1992. 

18 ‘‘(e) DEFINITION.—As used in this section: 

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

20 imaging’ means any examination or procedure used 

21 to visualize tissues, organs, or physiologic processes 

22 in humans for the purpose of detecting, diagnosing, 

23 treating, or impacting the progression of disease or 

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

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1 nostic procedures or ultrasound guidance of vascular 

2 access procedures. 

3 ‘‘(2) RADIATION THERAPY.—The term ‘radi4 ation therapy’ means any procedure or article in5 tended for use in the cure, mitigation, treatment, or 

6 prevention of disease in humans that achieves its in7 tended purpose through the emission of ionizing or 

8 non-ionizing radiation.’’. 

9 SEC. 4. STANDARDS FOR MEDICAL IMAGING AND RADI10 ATION THERAPY. 

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

12 U.S.C. 1395w–4(b)(4)) is amended by adding at the end 

13 the following new subparagraph: 

14 ‘‘(E) STANDARDS FOR MEDICAL IMAGING

15 AND RADIATION THERAPY.—With respect to ex16 penses incurred in the furnishing of the tech17 nical component of medical imaging examina18 tions or radiation therapy procedures for med19 ical purposes (as defined in subsection (e) of 

20 section 355 of the Public Health Service Act) 

21 on or after 42 months after the date of enact22 ment of the Consistency, Accuracy, Responsi23 bility, and Excellence in Medical Imaging and 

24 Radiation Therapy Act of 2013, payment shall 

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1 tion or procedure is furnished by an individual 

2 who meets the standards established by the 

3 Secretary under such section 355 (other than 

4 an individual described in subsection (a)(4)(A) 

5 of such section).’’. 

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

7 (a) IN GENERAL.—Not later than 5 years after the 

8 date of enactment of this Act, the Secretary of Health and 

9 Human Services, shall submit to the Committee on 

10 Health, Education, Labor, and Pensions of the Senate, the 

11 Committee on Finance of the Senate, and the Committee 

12 on Energy and Commerce of the House of Representa13 tives, a report on the effects of this Act. 

14 (b) REQUIREMENTS.—The report under subsection 

15 (a) shall include the types and numbers of individuals 

16 qualified to furnish the technical component of medical im17 aging or radiation therapy services for whom standards 

18 have been developed, the impact of such standards on di19 agnostic accuracy and patient safety, and the availability 

20 and cost of services. Entities reimbursed for technical 

21 services through programs operating under the authority 

22 of the Secretary of Health and Human Services shall be 

23 required to contribute data to such report. 

Æ 


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