II 

112TH CONGRESS 

2D SESSION S. 3338 

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 

JUNE 25, 2012 

Mr. ENZI (for himself, Mr. HARKIN, and Mr. WICKER) 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 2012’’. 


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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 perform or plan the technical component of either 

19 medical imaging examinations or radiation therapy 

20 procedures for medical purposes shall be fully quali21 fied under this section to perform or plan such serv22 ices. 

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

24 perform or plan the technical component of medical 

25 imaging examinations or radiation therapy proce26 dures shall— 


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1 ‘‘(A) possess current certification in the 

2 medical imaging or radiation therapy modality 

3 or service they plan or perform from a certifi4 cation organization designated under subsection 

5 (b); and 

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

7 licensure, certification, or registration, possess 

8 current State licensure or certifications where 

9 such services and modalities are within the 

10 scope of practice as defined by the State for 

11 such profession. 

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

13 REGISTRATION.— 

14 ‘‘(A) IN GENERAL.—Nothing in this sec15 tion shall be construed to diminish the author16 ity of a State to define requirements for licen17 sure, certification, or registration, the require18 ments for practice, or the scope of practice of 

19 personnel. 

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

21 not take any action under this section that 

22 would require licensure by a State of personnel 

23 who perform or plan the technical component of 

24 medical imaging examinations or radiation ther25 apy procedures. 


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1 ‘‘(4) EXEMPTIONS.— 

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

3 standards described in this subsection and the 

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

5 the Social Security Act shall not apply to physi6 cians (as defined in section 1861(r) of the So7 cial Security Act (42 U.S.C. 1395x(r))) or to 

8 nurse practitioners and physician assistants 

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

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

11 Such practitioners shall not be included under 

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

13 purposes of this section. 

14 ‘‘(B) INDIVIDUALS CURRENTLY EN15 ROLLED.—Individuals currently enrolled in a 

16 nuclear medicine, radiation therapy, or medical 

17 physicist training or certification program as of 

18 the date the Secretary publishes the list of ap19 proved certification organizations shall have 6 

20 months from the date of completion of the 

21 training program to become fully qualified as 

22 required under subsection (a). 

23 ‘‘(b) DESIGNATION OF CERTIFICATION ORGANIZA24 TIONS.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall estab2 lish a program for designating medical imaging or 

3 radiation therapy certification organizations that the 

4 Secretary determines have established appropriate 

5 procedures and programs for certifying personnel as 

6 qualified to furnish medical imaging or radiation 

7 therapy services. In establishing such program, the 

8 Secretary shall consult with professional organiza9 tions and recognized experts in the technical compo10 nent of medical imaging and radiation therapy serv11 ices. 

12 ‘‘(2) FACTORS.— 

13 ‘‘(A) IN GENERAL.—When designating cer14 tification organizations under this subsection, 

15 and when reviewing or modifying the list of des16 ignated organizations for the purposes of para17 graph (4)(B), the Secretary— 

18 ‘‘(i) shall consider— 

19 ‘‘(I) whether the certification or20 ganization has established a process 

21 for the timely integration of new med22 ical imaging or radiation therapy serv23 ices into the organization’s certifi24 cation program; 


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1 ‘‘(II) whether the certification or2 ganization has established education 

3 and continuing education require4 ments for individuals certified by the 

5 organization; 

6 ‘‘(III) whether the certification 

7 organization is a nonprofit organiza8 tion; 

9 ‘‘(IV) whether the certification 

10 organization requires completion of a 

11 certification examination as a pre12 requisite for certification; and 

13 ‘‘(V) whether the certification or14 ganization has been accredited by an 

15 accrediting body (as defined in sub16 paragraph (B)) that is approved by 

17 the Secretary; and 

18 ‘‘(ii) may consider— 

19 ‘‘(I) whether the certification or20 ganization has established reasonable 

21 fees to be charged to those applying 

22 for certification; and 

23 ‘‘(II) the ability of the certifi24 cation organization to review applicaVerDate Mar 15 2010 23:13 Jun 26, 2012 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3338.IS S3338

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1 tions for certification in a timely man2 ner. 

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

4 of this section, the term ‘accrediting body’ 

5 means and organization that— 

6 ‘‘(i) is a nonprofit organization; 

7 ‘‘(ii) is a national or international or8 ganization with accreditation programs for 

9 examinations leading to certification by 

10 certification organizations; and 

11 ‘‘(iii) has established standards for 

12 recordkeeping and to minimize the possi13 bility of conflicts of interest. 

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

15 EXPERIENCE.— 

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

17 section, the Secretary shall, through regulation, 

18 provide a process for individuals whose training 

19 or experience are determined to be equal to, or 

20 in excess of, those of a graduate of an accred21 ited educational program in that specialty to 

22 demonstrate their experience meets the edu23 cational standards for qualified personnel in 

24 their imaging modality or radiation therapy 


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1 procedures. Such process may include docu2 mentation of items such as— 

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

4 ‘‘(ii) a list of settings where experi5 ence was obtained; and 

6 ‘‘(iii) verification of experience by su7 pervising physicians or clinically qualified 

8 hospital personnel. 

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

10 not recognize any individual as having met the 

11 educational standards applicable under this 

12 paragraph based on experience pursuant to the 

13 authority of subparagraph (A) unless such indi14 vidual was performing or planning the technical 

15 component of medical imaging examinations or 

16 radiation therapy treatments prior to the date 

17 of enactment of this section. 

18 ‘‘(4) PROCESS.— 

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

20 months after the date of enactment of this sec21 tion, the Secretary shall promulgate regulations 

22 for designating certification organizations pur23 suant to this subsection. 

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

25 than 18 months after the date of enactment of 


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1 this section, the Secretary shall make deter2 minations regarding all certification organiza3 tions that have applied for designation pursuant 

4 to the regulations promulgated under subpara5 graph (A), and shall publish a list of all certifi6 cation organizations that have received a des7 ignation. 

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

9 The Secretary shall periodically review the list 

10 under subparagraph (B), taking into account 

11 the factors established under paragraph (2). 

12 After such review, the Secretary may, by regu13 lation, modify the list of certification organiza14 tions that have received such designation. 

15 ‘‘(D) WITHDRAWAL OF APPROVAL.—The 

16 Secretary may withdraw the approval of a cer17 tification organization listed under subpara18 graph (B) if the Secretary determines that the 

19 body no longer meets the requirements of sub20 section (b). 

21 ‘‘(E) CERTIFICATIONS PRIOR TO REMOVAL

22 FROM LIST.—If the Secretary removes a certifi23 cation organization from the list of certification 

24 organizations designated under subparagraph 

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


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1 certification organization during or before the 

2 period beginning on the date on which the cer3 tification organization was designated as a cer4 tification organization under such subpara5 graph, and ending 12 months from the date on 

6 which the certification organization is removed 

7 from such list, shall be considered to have been 

8 certified by a certification organization des9 ignated by the Secretary under such subpara10 graph for the remaining period that such cer11 tification is in effect. 

12 ‘‘(c) ALTERNATIVE STANDARDS FOR RURAL AND

13 UNDERSERVED AREAS.—The chief executive officer of a 

14 State may submit to the Secretary a statement declaring 

15 that the requirements described in subsection (a) are inap16 propriate for application for medical imaging examinations 

17 or radiation therapy procedures that are performed and 

18 planned in a geographic area that is determined by the 

19 Medicare Geographic Classification Review Board to be a 

20 ‘rural area’ or that is designated as a health professional 

21 shortage area. Upon receipt of such statement, if the Sec22 retary deems it appropriate, the Secretary may waive the 

23 standards described in subsection (a) or develop alter24 native standards for such rural areas or health profes25 sional shortage areas. 


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

2 any other provision of this section, individuals who provide 

3 medical imaging examinations relating to mammograms 

4 shall continue to meet the regulations applicable under the 

5 Mammography Quality Standards Act of 1992. 

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

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

8 imaging’ means any examination or procedure used 

9 to visualize tissues, organs, or physiologic processes 

10 in humans for the purpose of detecting, diagnosing, 

11 treating, or impacting the progression of disease or 

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

13 not include routine dental or ophthalmologic diag14 nostic procedures or ultrasound guidance of vascular 

15 access procedures. 

16 ‘‘(2) PERFORM.—The term ‘perform’, with re17 spect to medical imaging or radiation therapy, 

18 means— 

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

20 to radiation, including ionizing or radio fre21 quency radiation, to ultrasound, or to a mag22 netic field for purposes of medical imaging or 

23 for purposes of radiation therapy; and 

24 ‘‘(B) the act of positioning a patient to re25 ceive such an exposure. 


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

2 medical imaging or radiation therapy, means the act 

3 of preparing for the performance of such a proce4 dure on a patient by evaluating site-specific informa5 tion, based on measurement and verification of radi6 ation dose distribution, computer analysis, or direct 

7 measurement of dose, in order to customize the pro8 cedure for the patient. 

9 ‘‘(4) RADIATION THERAPY.—The term ‘radi10 ation therapy’ means any procedure or article in11 tended for use in the cure, mitigation, treatment, or 

12 prevention of disease in humans that achieves its in13 tended purpose through the emission of ionizing or 

14 non-ionizing radiation.’’. 

15 SEC. 4. STANDARDS FOR MEDICAL IMAGING AND RADI16 ATION THERAPY. 

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

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

19 the following new subparagraph: 

20 ‘‘(E) STANDARDS FOR MEDICAL IMAGING

21 AND RADIATION THERAPY.—With respect to ex22 penses incurred for the planning and per23 forming of the technical component of medical 

24 imaging examinations or radiation therapy pro25 cedures (as defined in subsection (f) of section 


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1 355 of the Public Health Service Act) furnished 

2 on or after 42 months after date of enactment 

3 of the Consistency, Accuracy, Responsibility, 

4 and Excellence in Medical Imaging and Radi5 ation Therapy Act of 2012, payment shall be 

6 made under this section only if the examination 

7 or procedure is planned or performed by an in8 dividual who meets the standards established by 

9 the Secretary under such section 355.’’. 

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

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

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

13 Human Services, shall submit to the Committee on 

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

15 Committee on Finance of the Senate, and the Committee 

16 on Energy and Commerce of the House of Representa17 tives, a report on the effects of this Act. 

18 (b) REQUIREMENTS.—The report under subsection 

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

20 qualified to perform or plan the technical component of 

21 medical imaging or radiation therapy services for whom 

22 standards have been developed, the impact of such stand23 ards on diagnostic accuracy and patient safety, and the 

24 availability and cost of services. Entities reimbursed for 

25 technical services through programs operating under the 


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1 authority of the Secretary of Health and Human Services 

2 shall be required to contribute data to such report. 

Æ 


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