II 

109TH CONGRESS 

2D SESSION S. 2322 

To amend the Public Health Service 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 

FEBRUARY 17, 2006 

Mr. ENZI (for himself and Mr. KENNEDY) 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 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 ‘‘Consumer Assurance 

5 of Radiologic Excellence Act of 2006’’. 

6 SEC. 2. PURPOSE. 

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

8 value of healthcare by increasing the safety and accuracy 


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1 of medical imaging examinations and radiation therapy 

2 treatments, thereby reducing duplication of services and 

3 decreasing costs. 

4 SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION 

5 THERAPY. 

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

7 (42 U.S.C. 262 et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘Subpart 4—Medical Imaging and Radiation Therapy 

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

11 THERAPY. 

12 ‘‘(a) ESTABLISHMENT OF STANDARDS.— 

13 ‘‘(1) IN GENERAL.—The Secretary, in consulta14 tion with recognized experts in the technical provi15 sion of medical imaging and radiation therapy serv16 ices, shall establish standards to ensure the safety 

17 and accuracy of medical imaging studies and radi18 ation therapy treatments. Such standards shall per19 tain to the personnel who perform, plan, evaluate, or 

20 verify patient dose for medical imaging studies and 

21 radiation therapy procedures and not to the equip22 ment used. 

23 ‘‘(2) EXPERTS.—The Secretary shall select ex24 pert advisers under paragraph (1) to reflect a broad 

25 and balanced input from all sectors of the health 


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1 care community that are involved in the provision of 

2 such services to avoid undue influence from any sin3 gle sector of practice on the content of such stand4 ards. 

5 ‘‘(3) LIMITATION.—The Secretary shall not 

6 take any action under this subsection that would re7 quire licensure by a State of those who provide the 

8 technical services referred to in this subsection. 

9 ‘‘(b) EXEMPTIONS.—The standards established 

10 under subsection (a) shall not apply to physicians (as de11 fined in section 1861(r) of the Social Security Act (42 

12 U.S.C. 1395x(r))), nurse practitioners and physician as13 sistants (as defined in section 1861(aa)(5) of the Social 

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

15 ‘‘(c) REQUIREMENTS.— 

16 ‘‘(1) IN GENERAL.—Under the standards estab17 lished under subsection (a), the Secretary shall en18 sure that individuals, prior to performing or plan19 ning medical imaging and radiation therapy services, 

20 demonstrate compliance with the standards estab21 lished under subsection (a) through successful com22 pletion of certification by a professional organiza23 tion, licensure, completion of an examination, perti24 nent coursework or degree program, verified perti25 nent experience, or through other ways determined 


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1 appropriate by the Secretary, or through some com2 bination thereof. 

3 ‘‘(2) MISCELLANEOUS PROVISIONS.—The 

4 standards established under subsection (a)— 

5 ‘‘(A) may vary from discipline to discipline, 

6 reflecting the unique and specialized nature of 

7 the technical services provided, and shall rep8 resent expert consensus as to what constitutes 

9 excellence in practice and be appropriate to the 

10 particular scope of care involved; 

11 ‘‘(B) may vary in form for each of the cov12 ered disciplines; and 

13 ‘‘(C) may exempt individual providers from 

14 meeting certain standards based on their scope 

15 of practice. 

16 ‘‘(3) RECOGNITION OF INDIVIDUALS WITH EX17 TENSIVE PRACTICAL EXPERIENCE.—For purposes of 

18 this section, the Secretary shall, through regulation, 

19 provide a method for the recognition of individuals 

20 whose training or experience are determined to be 

21 equal to, or in excess of, those of a graduate of an 

22 accredited educational program in that specialty, or 

23 of an individual who is regularly eligible to take the 

24 licensure or certification examination for that dis25 cipline. 


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1 ‘‘(d) APPROVED BODIES.— 

2 ‘‘(1) IN GENERAL.—Not later than the date de3 scribed in subsection (j)(2), the Secretary shall begin 

4 to certify qualified entities as approved bodies with 

5 respect to the accreditation of the various mecha6 nisms by which an individual can demonstrate com7 pliance with the standards promulgated under sub8 section (a), if such organizations or agencies meet 

9 the standards established by the Secretary under 

10 paragraph (2) and provide the assurances required 

11 under paragraph (3). 

12 ‘‘(2) STANDARDS.—The Secretary shall estab13 lish minimum standards for the certification of ap14 proved bodies under paragraph (1) (including stand15 ards for recordkeeping, the approval of curricula and 

16 instructors, the charging of reasonable fees for cer17 tification or for undertaking examinations, and 

18 standards to minimize the possibility of conflicts of 

19 interest), and other additional standards as the Sec20 retary may require. 

21 ‘‘(3) ASSURANCES.—To be certified as an ap22 proved body under paragraph (1), an organization or 

23 agency shall provide the Secretary satisfactory as24 surances that the body will— 

25 ‘‘(A) be a nonprofit organization; 


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1 ‘‘(B) comply with the standards described 

2 in paragraph (2); 

3 ‘‘(C) notify the Secretary in a timely man4 ner if the body fails to comply with the stand5 ards described in paragraph (2); and 

6 ‘‘(D) provide such other information as the 

7 Secretary may require. 

8 ‘‘(4) WITHDRAWAL OF APPROVAL.— 

9 ‘‘(A) IN GENERAL.—The Secretary may 

10 withdraw the certification of an approved body 

11 if the Secretary determines the body does not 

12 meet the standards under paragraph (2). 

13 ‘‘(B) EFFECT OF WITHDRAWAL.—The 

14 withdrawal of the certification of an approved 

15 body under subparagraph (A) shall have no ef16 fect on the certification status of any individual 

17 or person that was certified by that approved 

18 body prior to the date of such withdrawal. 

19 ‘‘(e) EXISTING STATE STANDARDS.—Standards es20 tablished by a State for the licensure or certification of 

21 personnel, accreditation of educational programs, or ad22 ministration of examinations shall be deemed to be in com23 pliance with the standards of this section unless the Sec24 retary determines that such State standards do not meet 


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1 the minimum standards prescribed by the Secretary or are 

2 inconsistent with the purposes of this section. 

3 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to prohibit a State or other ap5 proved body from requiring compliance with a higher 

6 standard of education and training than that specified by 

7 this section. 

8 ‘‘(g) EVALUATION AND REPORT.—The Secretary 

9 shall periodically evaluate the performance of each ap10 proved body under subsection (d) at an interval deter11 mined appropriate by the Secretary. The results of such 

12 evaluations shall be included as part of the report sub13 mitted to the Committee on Health, Education, Labor, 

14 and Pensions of the Senate and the Committee on Energy 

15 and Commerce of the House of Representatives in accord16 ance with 354(e)(6)(B). 

17 ‘‘(h) DELIVERY OF AND PAYMENT FOR SERVICES.— 

18 Not later than the date described in subsection (j)(3), the 

19 Secretary shall promulgate regulations to ensure that all 

20 programs under the authority of the Secretary that involve 

21 the performance of or payment for medical imaging or ra22 diation therapy, are performed in accordance with the 

23 standards established under this section. 

24 ‘‘(i) ALTERNATIVE STANDARDS FOR RURAL AND UN25 DERSERVED AREAS.—The Secretary shall determine 


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1 whether the standards established under subsection (a) 

2 must be met in their entirety for medical imaging or radi3 ation therapy that is performed in a geographic area that 

4 is determined by the Medicare Geographic Classification 

5 Review Board to be a ‘rural area’ or that is designated 

6 as a health professional shortage area. If the Secretary 

7 determines that alternative standards for such rural areas 

8 or health professional shortage areas are appropriate to 

9 assure access to quality medical imaging, the Secretary 

10 is authorized to develop such alternative standards. 

11 ‘‘(j) APPLICABLE TIMELINES.— 

12 ‘‘(1) GENERAL IMPLEMENTATION REGULA13 TIONS.—Not later than 18 months after the date of 

14 enactment of this section, the Secretary shall pro15 mulgate such regulations as may be necessary to im16 plement all standards in this section except those 

17 provided for in subsection (d)(2). 

18 ‘‘(2) MINIMUM STANDARDS FOR CERTIFICATION

19 OF APPROVED BODIES.—Not later than 24 months 

20 after the date of enactment of this section, the Sec21 retary shall establish the standards regarding ap22 proved bodies referred to in subsection (d)(2) and 

23 begin certifying approved bodies under such sub24 section. 


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1 ‘‘(3) REGULATIONS FOR DELIVERY OF OR PAY2 MENT FOR SERVICES.—Not later than 36 months 

3 after the date of enactment of this section, the Sec4 retary shall promulgate the regulations described in 

5 subsection (h). The Secretary may withhold the pro6 vision of Federal assistance as provided for in sub7 section (h) beginning on the date that is 48 months 

8 after the date of enactment of this section. 

9 ‘‘(k) DEFINITIONS.—In this section: 

10 ‘‘(1) APPROVED BODY.—The term ‘approved 

11 body’ means an entity that has been certified by the 

12 Secretary under subsection (d)(1) to accredit the 

13 various mechanisms by which an individual can dem14 onstrate compliance with the standards promulgated 

15 under subsection (a) with respect to performing, 

16 planning, evaluating, or verifying patient dose for 

17 medical imaging or radiation therapy. 

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

19 imaging’ means any procedure used to visualize tis20 sues, organs, or physiologic processes in humans for 

21 the purpose of diagnosing illness or following the 

22 progression of disease. Images may be produced uti23 lizing ionizing radiation, radiopharmaceuticals, mag24 netic resonance, or ultrasound and image production 

25 may include the use of contrast media or computer 


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1 processing. For purposes of this section, such term 

2 does not include routine dental diagnostic proce3 dures. 

4 ‘‘(3) PERFORM.—The term ‘perform’, with re5 spect to medical imaging or radiation therapy, 

6 means— 

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

8 to radiation via ionizing or radio frequency ra9 diation, to ultrasound, or to a magnetic field for 

10 purposes of medical imaging or for purposes of 

11 radiation therapy; and 

12 ‘‘(B) the act of positioning a patient to re13 ceive such an exposure. 

14 ‘‘(4) PLAN.—The term ‘plan’, with respect to 

15 medical imaging or radiation therapy, means the act 

16 of preparing for the performance of such a proce17 dure to a patient by evaluating site-specific informa18 tion, based on measurement and verification of radi19 ation dose distribution, computer analysis, or direct 

20 measurement of dose, in order to customize the pro21 cedure for the patient. 

22 ‘‘(5) 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 prevention of disease in humans that achieves its in2 tended purpose through the emission of radiation.’’. 

3 SEC. 4. REPORT ON THE EFFECTS OF THIS ACT. 

4 (a) Not later than 5 years after the date of enactment 

5 of this Act, the Secretary of Health and Human Services, 

6 acting through the Director of the Agency for Healthcare 

7 Research and Quality, shall submit to the Committee on 

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

9 the Committee on Energy and Commerce of the House 

10 of Representatives a report on the effects of this Act. Such 

11 report shall include the types and numbers of providers 

12 for whom standards have been developed, the impact of 

13 such standards on diagnostic accuracy and patient safety, 

14 and the availability and cost of services. Entities reim15 bursed for technical services through programs operating 

16 under the authority of the Secretary of Health and 

17 Human Services shall be required to contribute data to 

18 such report. 

Æ 


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