I 

113TH CONGRESS 

1ST SESSION H. R. 1146 

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 

MARCH 13, 2013 

Mr. WHITFIELD (for himself, Mr. BARROW of Georgia, and Ms. SCHWARTZ) 

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, 


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1 SECTION 1. SHORT TITLE. 

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

3 Responsibility, and Excellence in Medical Imaging and 

4 Radiation Therapy Act of 2013’’. 

5 SEC. 2. PURPOSE. 

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

7 value of health care by increasing the safety and accuracy 

8 of medical imaging examinations and radiation therapy 

9 procedures, thereby reducing duplication of services and 

10 decreasing costs. 

11 SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION 

12 THERAPY. 

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

14 (42 U.S.C. 262 et seq.) is amended by adding at the end 

15 the following: 

16 ‘‘Subpart 4—Medical Imaging and Radiation Therapy 

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

18 THERAPY. 

19 ‘‘(a) QUALIFIED PERSONNEL.— 

20 ‘‘(1) IN GENERAL.—Effective 42 months after 

21 the date of enactment of this section, personnel who 

22 furnish the technical component of either medical 

23 imaging examinations or radiation therapy proce24 dures for medical purposes (except exempt individ25 uals as described in paragraph (4)) shall be fully 

26 qualified under this section to furnish such services. 


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

2 furnish the technical component of medical imaging 

3 examinations or radiation therapy procedures 

4 shall— 

5 ‘‘(A) possess current certification in the 

6 medical imaging or radiation therapy modality 

7 or service they furnish from a certification or8 ganization designated under subsection (b); or 

9 ‘‘(B) possess current State licensure or 

10 certification, where— 

11 ‘‘(i) such services and modalities are 

12 within the scope of practice as defined by 

13 the State for such profession; and 

14 ‘‘(ii) the requirements for licensure, 

15 certification, or registration meet or exceed 

16 the standards established by the certifi17 cation organization designated under sub18 section (b). 

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

20 REGISTRATION.— 

21 ‘‘(A) IN GENERAL.—Nothing in this sec22 tion shall be construed to diminish the author23 ity of a State to define requirements for licen24 sure, certification, or registration, the requireVerDate Mar 14 2013 01:56 Mar 20, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1146.IH H1146

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1 ments for practice, or the scope of practice of 

2 personnel. 

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

4 not take any action under this section that 

5 would require licensure by a State of personnel 

6 who furnish the technical component of medical 

7 imaging examinations or radiation therapy pro8 cedures. 

9 ‘‘(4) EXEMPTIONS.— 

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

11 standards described in this subsection and the 

12 payment provisions in section 1848(b)(4)(E) of 

13 the Social Security Act shall not apply to physi14 cians (as defined in section 1861(r) of the So15 cial Security Act (42 U.S.C. 1395x(r))) or to 

16 nurse practitioners and physician assistants 

17 (each as defined in section 1861(aa)(5) of the 

18 Social Security Act (42 U.S.C. 1395x(aa)(5))). 

19 Such practitioners shall not be included under 

20 the terms ‘personnel’ or ‘qualified personnel’ for 

21 purposes of this section. 

22 ‘‘(B) INDIVIDUALS CURRENTLY EN23 ROLLED.—Individuals currently enrolled in a 

24 nuclear medicine, radiation therapy, or medical 

25 physicist training or certification program as of 


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1 the date the Secretary publishes the list of ap2 proved certification organizations shall have 6 

3 months from the date of completion of the 

4 training program to become fully qualified as 

5 required under subsection (a). 

6 ‘‘(b) DESIGNATION OF CERTIFICATION ORGANIZA7 TIONS.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall estab9 lish a program for designating medical imaging or 

10 radiation therapy certification organizations that the 

11 Secretary determines have established appropriate 

12 procedures and programs for certifying personnel as 

13 qualified to furnish medical imaging or radiation 

14 therapy services. In establishing such program, the 

15 Secretary shall consult with professional organiza16 tions and recognized experts in the technical compo17 nent of medical imaging and radiation therapy serv18 ices. 

19 ‘‘(2) FACTORS.— 

20 ‘‘(A) IN GENERAL.—When designating cer21 tification organizations under this subsection, 

22 and when reviewing or modifying the list of des23 ignated organizations for the purposes of para24 graph (4)(B), the Secretary— 

25 ‘‘(i) shall consider— 


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1 ‘‘(I) whether the certification or2 ganization has established a process 

3 for the timely integration of new med4 ical imaging or radiation therapy serv5 ices into the organization’s certifi6 cation program; 

7 ‘‘(II) whether the certification or8 ganization has established education 

9 and continuing education require10 ments for individuals certified by the 

11 organization; 

12 ‘‘(III) whether the certification 

13 organization is a nonprofit organiza14 tion; 

15 ‘‘(IV) whether the certification 

16 organization requires completion of a 

17 certification examination as a pre18 requisite for certification; and 

19 ‘‘(V) whether the certification or20 ganization has been accredited by an 

21 accrediting body (as defined in sub22 paragraph (B)) that is approved by 

23 the Secretary; and 

24 ‘‘(ii) may consider— 


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1 ‘‘(I) whether the certification or2 ganization has established reasonable 

3 fees to be charged to those applying 

4 for certification; and 

5 ‘‘(II) the ability of the certifi6 cation organization to review applica7 tions for certification in a timely man8 ner. 

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

10 of this section, the term ‘accrediting body’ 

11 means an organization that— 

12 ‘‘(i) is a nonprofit organization; 

13 ‘‘(ii) is a national or international or14 ganization with accreditation programs for 

15 examinations leading to certification by 

16 certification organizations; and 

17 ‘‘(iii) has established standards for 

18 recordkeeping and to minimize the possi19 bility of conflicts of interest. 

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

21 EXPERIENCE.— 

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

23 section, the Secretary shall, through regulation, 

24 provide a process for individuals whose training 

25 or experience are determined to be equal to, or 


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1 in excess of, those of a graduate of an accred2 ited educational program in that specialty to 

3 demonstrate their experience meets the edu4 cational standards for qualified personnel in 

5 their imaging modality or radiation therapy 

6 procedures. Such process may include docu7 mentation of items such as— 

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

9 ‘‘(ii) a list of settings where experi10 ence was obtained; and 

11 ‘‘(iii) verification of experience by su12 pervising physicians or clinically qualified 

13 hospital personnel. 

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

15 not recognize any individual as having met the 

16 educational standards applicable under this 

17 paragraph based on experience pursuant to the 

18 authority of subparagraph (A) unless such indi19 vidual was furnishing the technical component 

20 of medical imaging examinations or radiation 

21 therapy treatments prior to the date of enact22 ment of this section. 

23 ‘‘(4) PROCESS.— 

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

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1 tion, the Secretary shall promulgate regulations 

2 for designating certification organizations pur3 suant to this subsection. 

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

5 than 18 months after the date of enactment of 

6 this section, the Secretary shall make deter7 minations regarding all certification organiza8 tions that have applied for designation pursuant 

9 to the regulations promulgated under subpara10 graph (A), and shall publish a list of all certifi11 cation organizations that have received a des12 ignation. 

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

14 The Secretary shall periodically review the list 

15 under subparagraph (B), taking into account 

16 the factors established under paragraph (2). 

17 After such review, the Secretary may, by regu18 lation, modify the list of certification organiza19 tions that have received such designation. 

20 ‘‘(D) WITHDRAWAL OF APPROVAL.—The 

21 Secretary may withdraw the approval of a cer22 tification organization listed under subpara23 graph (B) if the Secretary determines that the 

24 body no longer meets the requirements of this 

25 subsection. 


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1 ‘‘(E) CERTIFICATIONS PRIOR TO REMOVAL

2 FROM LIST.—If the Secretary removes a certifi3 cation organization from the list of certification 

4 organizations designated under subparagraph 

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

6 certification organization during or before the 

7 period beginning on the date on which the cer8 tification organization was designated as a cer9 tification organization under such subpara10 graph, and ending 12 months from the date on 

11 which the certification organization is removed 

12 from such list, shall be considered to have been 

13 certified by a certification organization des14 ignated by the Secretary under such subpara15 graph for the remaining period that such cer16 tification is in effect. 

17 ‘‘(c) ALTERNATIVE STANDARDS FOR RURAL AND

18 UNDERSERVED AREAS.—The chief executive officer of a 

19 State may submit to the Secretary a statement declaring 

20 that the requirements described in subsection (a) are inap21 propriate for application for medical imaging examinations 

22 or radiation therapy procedures that are furnished in a 

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

24 (as such term is defined for purposes of section 

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1 ignated as a health professional shortage area (as defined 

2 in section 332 of this Act). Upon receipt of such state3 ment, if the Secretary deems it appropriate, the Secretary 

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

5 develop alternative standards for such rural areas or 

6 health professional shortage areas. 

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

8 any other provision of this section, individuals who provide 

9 medical imaging examinations relating to mammograms 

10 shall continue to meet the regulations applicable under the 

11 Mammography Quality Standards Act of 1992. 

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

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

14 imaging’ means any examination or procedure used 

15 to visualize tissues, organs, or physiologic processes 

16 in humans for the purpose of detecting, diagnosing, 

17 treating, or impacting the progression of disease or 

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

19 not include routine dental or ophthalmologic diag20 nostic procedures or ultrasound guidance of vascular 

21 access procedures. 

22 ‘‘(2) RADIATION THERAPY.—The term ‘radi23 ation therapy’ means any procedure or article in24 tended for use in the cure, mitigation, treatment, or 

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1 tended purpose through the emission of ionizing or 

2 non-ionizing radiation.’’. 

3 SEC. 4. STANDARDS FOR MEDICAL IMAGING AND RADI4 ATION THERAPY. 

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

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

7 the following new subparagraph: 

8 ‘‘(E) STANDARDS FOR MEDICAL IMAGING

9 AND RADIATION THERAPY.—With respect to ex10 penses incurred in the furnishing of the tech11 nical component of medical imaging examina12 tions or radiation therapy procedures for med13 ical purposes (as defined in subsection (e) of 

14 section 355 of the Public Health Service Act) 

15 on or after 42 months after date of enactment 

16 of the Consistency, Accuracy, Responsibility, 

17 and Excellence in Medical Imaging and Radi18 ation Therapy Act of 2013, payment shall be 

19 made under this section only if the examination 

20 or procedure is furnished by an individual who 

21 meets the standards established by the Sec22 retary under such section 355 (other than an 

23 individual described in subsection (a)(4)(B)(i) 

24 of such section).’’. 


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

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

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

4 Human Services, shall submit to the Committee on 

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

6 Committee on Finance of the Senate, and the Committee 

7 on Energy and Commerce of the House of Representa8 tives, a report on the effects of this Act. 

9 (b) REQUIREMENTS.—The report under subsection 

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

11 qualified to furnish the technical component of medical im12 aging or radiation therapy services for whom standards 

13 have been developed, the impact of such standards on di14 agnostic accuracy and patient safety, and the availability 

15 and cost of services. Entities reimbursed for technical 

16 services through programs operating under the authority 

17 of the Secretary of Health and Human Services shall be 

18 required to contribute data to such report. 

Æ 


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