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 accurate, 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. MCINTYRE, Mrs. MYRICK, Ms. RICHARDSON, and Mr. RUSH) 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 2011’’. 

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 January 1, 2014, 

21 personnel who perform or plan the technical compo22 nent of either medical imaging examinations or radi23 ation therapy procedures for medical purposes shall 

24 be qualified under this section to perform or plan 

25 such services. 


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

2 perform or plan the technical component of medical 

3 imaging examinations or radiation therapy proce4 dures shall— 

5 ‘‘(A) possess current certification in the 

6 medical imaging or radiation therapy modality 

7 or service they plan or perform from a certifi8 cation organization designated by the Secretary 

9 pursuant to subsection (c); or 

10 ‘‘(B) possess current State licensure or 

11 certification, where— 

12 ‘‘(i) such services and modalities are 

13 within the scope of practice as defined by 

14 the State for such profession; and 

15 ‘‘(ii) the requirements for licensure, 

16 certification, or registration meet or exceed 

17 the standards established by the Secretary 

18 pursuant to this section. 

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 15 2010 03:08 Jun 08, 2011 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2104.IH H2104

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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 perform or plan the technical component of 

7 medical imaging examinations or radiation ther8 apy procedures. 

9 ‘‘(4) EXEMPTIONS.—The qualification stand10 ards described in this subsection and the payment 

11 provisions in section 1848(b)(4)(C) of the Social Se12 curity Act shall not apply to physicians (as defined 

13 in section 1861(r) of the Social Security Act (42 

14 U.S.C. 1395x(r))) or to nurse practitioners and phy15 sician assistants (each as defined in section 

16 1861(aa)(5) of the Social Security Act (42 U.S.C. 

17 1395x(aa)(5))). Such practitioners shall not be in18 cluded under the terms ‘personnel’ or ‘qualified per19 sonnel’ for purposes of this section. 

20 ‘‘(b) ESTABLISHMENT OF STANDARDS.— 

21 ‘‘(1) IN GENERAL.—For the purposes of deter22 mining compliance with subsection (a), the Sec23 retary, in consultation with recognized experts in the 

24 technical provision of medical imaging or radiation 

25 therapy services, shall establish minimum standards 


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

2 patient dose for medical imaging examinations or ra3 diation therapy procedures. Such standards shall not 

4 apply to the equipment used. 

5 ‘‘(2) RECOGNIZED EXPERTS.— 

6 ‘‘(A) IN GENERAL.—For the purposes of 

7 this subsection, the Secretary shall select recog8 nized expert advisers to reflect a broad and bal9 anced input from all sectors of the health care 

10 community that are involved in the provision of 

11 services of the type described in paragraph (1) 

12 to avoid undue influence from any single sector 

13 of practice relating to the content of such 

14 standards. 

15 ‘‘(B) DEFINITION.—In this paragraph, the 

16 term ‘recognized experts’ includes— 

17 ‘‘(i) representatives of all medical spe18 cialties and providers that perform or plan 

19 medical imaging procedures; 

20 ‘‘(ii) representatives of all medical 

21 specialties and providers that perform or 

22 plan radiation therapy procedures; 

23 ‘‘(iii) medical imaging and radiation 

24 therapy technology experts; and 


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1 ‘‘(iv) other experts determined appro2 priate by the Secretary. 

3 ‘‘(3) MINIMUM STANDARDS.—Minimum stand4 ards established under this subsection shall reflect 

5 the unique or specialized nature of the technical 

6 services provided, and shall represent expert con7 sensus from those practicing in each of the covered 

8 imaging modalities and radiation therapy procedures 

9 as to what constitutes excellence in practice and be 

10 appropriate to the particular 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 standards that 

15 exceed the minimum standards specified by the Sec16 retary pursuant to this subsection. 

17 ‘‘(5) TIMELINE.—Not later than 12 months 

18 after the date of enactment of this section, the Sec19 retary shall promulgate regulations for the purposes 

20 of carrying out this subsection. 

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 under this subsection, and when re6 viewing or modifying the list of designated organiza7 tions for the purposes of paragraph (4)(B), the Sec8 retary shall consider— 

9 ‘‘(A) whether the certification organization 

10 has established certification requirements for 

11 individuals that are consistent with or exceed 

12 the minimum standards established in sub13 section (b); 

14 ‘‘(B) whether the certification organization 

15 has established a process for the timely integra16 tion of new medical imaging or radiation ther17 apy services into the organization’s certification 

18 program; 

19 ‘‘(C) whether the certification organization 

20 has established education and continuing edu21 cation requirements for individuals certified by 

22 the organization; 

23 ‘‘(D) whether the organization has estab24 lished reasonable fees to be charged to those 

25 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 process for individuals whose training 

15 or experience are determined to be equal to, or 

16 in excess of, those of a graduate of an accred17 ited educational program in that specialty to 

18 demonstrate their experience meets the edu19 cational standards for qualified personnel in 

20 their imaging modality or radiation therapy 

21 procedures. Such process may include docu22 mentation of items such as— 

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

24 ‘‘(ii) a list of settings where experi25 ence was obtained; and 


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1 ‘‘(iii) verification of experience by su2 pervising physicians or clinically qualified 

3 hospital personnel. 

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

5 not recognize any individual as having met the 

6 educational standards applicable under this 

7 paragraph based on experience pursuant to the 

8 authority of subparagraph (A) unless such indi9 vidual was performing or planning the technical 

10 component of medical imaging examinations or 

11 radiation therapy treatments prior to the date 

12 of enactment of this section. 

13 ‘‘(C) CERTIFICATION TEST REQUIRE14 MENT.—To be eligible to be certified under this 

15 subsection an individual shall, not later than 18 

16 months after the date on which the list of des17 ignated certification organizations is published 

18 under paragraph (4), successfully complete a 

19 certification examination administered by a des20 ignated certification organization. During such 

21 18-month period, the penalties provided for 

22 under section 1848(b)(4)(C) of the Social Secu23 rity Act (as added by section 4 of the Consist24 ency, Accuracy, Responsibility, and Excellence 


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1 in Medical Imaging and Radiation Therapy Act 

2 of 2011) shall not apply to such individuals. 

3 ‘‘(4) PROCESS.— 

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

5 1, 2013, the Secretary shall promulgate regula6 tions for designating certification organizations 

7 pursuant to this subsection. 

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

9 than January 1, 2014, the Secretary shall make 

10 determinations regarding all certification orga11 nizations that have applied for designation pur12 suant to the regulations promulgated under 

13 subparagraph (A), and shall publish a list of all 

14 certification organizations that have received a 

15 designation. 

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

17 The Secretary shall periodically review the list 

18 under subparagraph (B), taking into account 

19 the factors established under paragraph (2). 

20 After such review, the Secretary may, by regu21 lation, modify the list of certification organiza22 tions that have received such designation. 

23 ‘‘(D) CERTIFICATIONS PRIOR TO REMOVAL

24 FROM LIST.—If the Secretary removes a certifi25 cation organization from the list of certification 


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1 organizations designated under subparagraph 

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

3 certification organization during or before the 

4 period beginning on the date on which the cer5 tification organization was designated as a cer6 tification organization under such subpara7 graph, and ending on the date on which the cer8 tification organization is removed from such 

9 list, shall be considered to have been certified 

10 by a certification organization designated by the 

11 Secretary under such subparagraph for the re12 maining period that such certification is in ef13 fect. 

14 ‘‘(d) APPROVED ACCREDITING BODIES.— 

15 ‘‘(1) IN GENERAL.—Not later than 24 months 

16 after the date of enactment of this section, the Sec17 retary shall publish a list of entities that are ap18 proved accrediting bodies for certification organiza19 tions for purposes of subsection (c)(2)(E). The Sec20 retary shall revise such list as appropriate. 

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

22 Secretary shall not approve an accrediting body for 

23 certification organizations under this subsection un24 less the Secretary determines that such accrediting 

25 body— 


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1 ‘‘(A) is a nonprofit organization; 

2 ‘‘(B) is a national or international organi3 zation with accreditation programs for examina4 tions leading to certification by certification or5 ganizations; 

6 ‘‘(C) has established standards for record7 keeping and to minimize the possibility of con8 flicts of interest; and 

9 ‘‘(D) demonstrates compliance with any 

10 other requirements established by the Sec11 retary. 

12 ‘‘(3) WITHDRAWAL OF APPROVAL.—The Sec13 retary may withdraw the approval of an accrediting 

14 body under this paragraph if the Secretary deter15 mines that the body does not meet the requirements 

16 of paragraph (2). 

17 ‘‘(e) ALTERNATIVE STANDARDS FOR RURAL AND

18 UNDERSERVED AREAS.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall deter20 mine whether the standards established under sub21 section (a) must be met in their entirety for medical 

22 imaging examinations or radiation therapy proce23 dures that are performed and planned in a geo24 graphic area that is determined by the Medicare Ge25 ographic Classification Review Board to be a ‘rural 


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1 area’ or that is designated as a health professional 

2 shortage area. If the Secretary determines that al3 ternative standards for such rural areas or health 

4 professional shortage areas are appropriate to en5 sure access to quality medical imaging examinations 

6 or radiation therapy procedures, the Secretary is au7 thorized to develop such alternative standards. 

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

9 officer of a State may submit to the Secretary a 

10 statement declaring that an alternative standard de11 veloped under paragraph (1) is inappropriate for ap12 plication to such State, and such alternative stand13 ard shall not apply in such submitting State. The 

14 chief executive officer of a State may rescind a 

15 statement described in this paragraph following the 

16 provision of appropriate notice to the Secretary. 

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

18 any other provision of this section, individuals who provide 

19 medical imaging examinations relating to mammograms 

20 shall continue to meet the regulations applicable under the 

21 Mammography Quality Standards Act of 1992 (as amend22 ed). 

23 ‘‘(g) DEFINITION.—As used in this section: 

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

25 imaging’ means any examination or procedure used 


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1 to visualize tissues, organs, or physiologic processes 

2 in humans for the purpose of detecting, diagnosing, 

3 treating, or impacting the progression of disease or 

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

5 not include routine dental or ophthalmologic diag6 nostic procedures or ultrasound guidance of vascular 

7 access procedures. 

8 ‘‘(2) PERFORM.—The term ‘perform’, with re9 spect to medical imaging or radiation therapy, 

10 means— 

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

12 to radiation, including ionizing or radio fre13 quency radiation, to ultrasound, or to a mag14 netic field for purposes of medical imaging or 

15 for purposes of radiation therapy; and 

16 ‘‘(B) the act of positioning a patient to re17 ceive such an exposure. 

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

19 medical imaging or radiation therapy, means the act 

20 of preparing for the performance of such a proce21 dure on a patient by evaluating site-specific informa22 tion, based on measurement and verification of radi23 ation dose distribution, computer analysis, or direct 

24 measurement of dose, in order to customize the pro25 cedure for the patient. 


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1 ‘‘(4) RADIATION THERAPY.—The term ‘radi2 ation therapy’ means any procedure or article in3 tended for use in the cure, mitigation, treatment, or 

4 prevention of disease in humans that achieves its in5 tended purpose through the emission of ionizing or 

6 non-ionizing radiation.’’. 

7 SEC. 4. REQUIRED STANDARDS FOR MEDICAL IMAGING 

8 AND RADIATION THERAPY. 

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

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

11 the following new subparagraph: 

12 ‘‘(E) REQUIRED STANDARDS FOR MEDICAL

13 IMAGING AND RADIATION THERAPY SERV14 ICES.—With respect to expenses incurred for 

15 the planning and performing of the technical 

16 component of medical imaging examinations or 

17 radiation therapy procedures (as defined in sub18 section (g) of section 355 of the Public Health 

19 Service Act) furnished on or after January 1, 

20 2014, payment shall be made under this section 

21 only if the examination or procedure is planned 

22 or performed by an individual who meets the 

23 requirements established by the Secretary under 

24 such section 355.’’. 


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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 the enactment of this Act, the Secretary of Health 

4 and Human Services, acting through the Director of the 

5 Agency for Healthcare Research and Quality, shall submit 

6 to the Committee on Health, Education, Labor, and Pen7 sions of the Senate, the Committee on Finance of the Sen8 ate, and the Committee on Energy and Commerce of the 

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

10 Act. 

11 (b) REQUIREMENTS.—The report under subsection 

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

13 qualified to perform or plan the technical component of 

14 medical imaging or radiation therapy services for whom 

15 standards have been developed, the impact of such stand16 ards on diagnostic accuracy and patient safety, and the 

17 availability and cost of services. Entities reimbursed for 

18 technical services through programs operating under the 

19 authority of the Secretary of Health and Human Services 

20 shall be required to contribute data to such report. 

Æ 


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