II 

Calendar No. 668 

109TH CONGRESS 

2D SESSION S. 2322 

[Report No. 109–363] 

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, Mr. KENNEDY, Mr. BINGAMAN, Mr. HAGEL, Mr. 

BIDEN, Mr. DOMENICI, Mr. DURBIN, Mr. COCHRAN, Mr. JOHNSON, Mr. 

CONRAD, Mr. THUNE, Mr. LAUTENBERG, Mr. ISAKSON, Mr. LIEBERMAN, 

Mr. LOTT, Mr. BURR, Mr. DODD, Mr. DORGAN, and Mr. HATCH) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

DECEMBER 5, 2006 

Reported by Mr. ENZI, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Consumer Assurance 

3 of Radiologic Excellence Act of 2006’’. 

4 SEC. 2. PURPOSE. 

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

6 value of healthcare by increasing the safety and accuracy 

7 of medical imaging examinations and radiation therapy 

8 treatments, thereby reducing duplication of services and 

9 decreasing costs. 

10 SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION 

11 THERAPY. 

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

13 (42 U.S.C. 262 et seq.) is amended by adding at the end 

14 the following: 

15 ‘‘Subpart 4—Medical Imaging and Radiation Therapy 

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

17 THERAPY. 

18 ‘‘(a) ESTABLISHMENT OF STANDARDS.— 

19 ‘‘(1) IN GENERAL.—The Secretary, in consulta20 tion with recognized experts in the technical provi21 sion of medical imaging and radiation therapy serv22 ices, shall establish standards to ensure the safety 

23 and accuracy of medical imaging studies and radi24 ation therapy treatments. Such standards shall per25 tain to the personnel who perform, plan, evaluate, or 

26 verify patient dose for medical imaging studies and 


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1 radiation therapy procedures and not to the equip2 ment used. 

3 ‘‘(2) EXPERTS.—The Secretary shall select ex4 pert advisers under paragraph (1) to reflect a broad 

5 and balanced input from all sectors of the health 

6 care community that are involved in the provision of 

7 such services to avoid undue influence from any sin8 gle sector of practice on the content of such stand9 ards. 

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

11 take any action under this subsection that would re12 quire licensure by a State of those who provide the 

13 technical services referred to in this subsection. 

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

15 under subsection (a) shall not apply to physicians (as de16 fined in section 1861(r) of the Social Security Act (42 

17 U.S.C. 1395x(r))), nurse practitioners and physician as18 sistants (as defined in section 1861(aa)(5) of the Social 

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

20 ‘‘(c) REQUIREMENTS.— 

21 ‘‘(1) IN GENERAL.—Under the standards estab22 lished under subsection (a), the Secretary shall en23 sure that individuals, prior to performing or plan24 ning medical imaging and radiation therapy services, 

25 demonstrate compliance with the standards estabVerDate Aug 31 2005 05:14 Dec 06, 2006 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S2322.RS S2322

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1 lished under subsection (a) through successful com2 pletion of certification by a professional organiza3 tion, licensure, completion of an examination, perti4 nent coursework or degree program, verified perti5 nent experience, or through other ways determined 

6 appropriate by the Secretary, or through some com7 bination thereof. 

8 ‘‘(2) MISCELLANEOUS PROVISIONS.—The 

9 standards established under subsection (a)— 

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

11 reflecting the unique and specialized nature of 

12 the technical services provided, and shall rep13 resent expert consensus as to what constitutes 

14 excellence in practice and be appropriate to the 

15 particular scope of care involved; 

16 ‘‘(B) may vary in form for each of the cov17 ered disciplines; and 

18 ‘‘(C) may exempt individual providers from 

19 meeting certain standards based on their scope 

20 of practice. 

21 ‘‘(3) RECOGNITION OF INDIVIDUALS WITH EX22 TENSIVE PRACTICAL EXPERIENCE.—For purposes of 

23 this section, the Secretary shall, through regulation, 

24 provide a method for the recognition of individuals 

25 whose training or experience are determined to be 


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

2 accredited educational program in that specialty, or 

3 of an individual who is regularly eligible to take the 

4 licensure or certification examination for that dis5 cipline. 

6 ‘‘(d) APPROVED BODIES.— 

7 ‘‘(1) IN GENERAL.—Not later than the date de8 scribed in subsection (j)(2), the Secretary shall begin 

9 to certify qualified entities as approved bodies with 

10 respect to the accreditation of the various mecha11 nisms by which an individual can demonstrate com12 pliance with the standards promulgated under sub13 section (a), if such organizations or agencies meet 

14 the standards established by the Secretary under 

15 paragraph (2) and provide the assurances required 

16 under paragraph (3). 

17 ‘‘(2) STANDARDS.—The Secretary shall estab18 lish minimum standards for the certification of ap19 proved bodies under paragraph (1) (including stand20 ards for recordkeeping, the approval of curricula and 

21 instructors, the charging of reasonable fees for cer22 tification or for undertaking examinations, and 

23 standards to minimize the possibility of conflicts of 

24 interest), and other additional standards as the Sec25 retary may require. 


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1 ‘‘(3) ASSURANCES.—To be certified as an ap2 proved body under paragraph (1), an organization or 

3 agency shall provide the Secretary satisfactory as4 surances that the body will— 

5 ‘‘(A) be a nonprofit organization; 

6 ‘‘(B) comply with the standards described 

7 in paragraph (2); 

8 ‘‘(C) notify the Secretary in a timely man9 ner if the body fails to comply with the stand10 ards described in paragraph (2); and 

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

12 Secretary may require. 

13 ‘‘(4) WITHDRAWAL OF APPROVAL.— 

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

15 withdraw the certification of an approved body 

16 if the Secretary determines the body does not 

17 meet the standards under paragraph (2). 

18 ‘‘(B) EFFECT OF WITHDRAWAL.—The 

19 withdrawal of the certification of an approved 

20 body under subparagraph (A) shall have no ef21 fect on the certification status of any individual 

22 or person that was certified by that approved 

23 body prior to the date of such withdrawal. 

24 ‘‘(e) EXISTING STATE STANDARDS.—Standards es25 tablished by a State for the licensure or certification of 


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1 personnel, accreditation of educational programs, or ad2 ministration of examinations shall be deemed to be in com3 pliance with the standards of this section unless the Sec4 retary determines that such State standards do not meet 

5 the minimum standards prescribed by the Secretary or are 

6 inconsistent with the purposes of this section. 

7 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec8 tion shall be construed to prohibit a State or other ap9 proved body from requiring compliance with a higher 

10 standard of education and training than that specified by 

11 this section. 

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

13 shall periodically evaluate the performance of each ap14 proved body under subsection (d) at an interval deter15 mined appropriate by the Secretary. The results of such 

16 evaluations shall be included as part of the report sub17 mitted to the Committee on Health, Education, Labor, 

18 and Pensions of the Senate and the Committee on Energy 

19 and Commerce of the House of Representatives in accord20 ance with 354(e)(6)(B). 

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

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

23 Secretary shall promulgate regulations to ensure that all 

24 programs under the authority of the Secretary that involve 

25 the performance of or payment for medical imaging or raVerDate Aug 31 2005 05:14 Dec 06, 2006 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S2322.RS S2322

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1 diation therapy, are performed in accordance with the 

2 standards established under this section. 

3 ‘‘(i) ALTERNATIVE STANDARDS FOR RURAL AND UN4 DERSERVED AREAS.—The Secretary shall determine 

5 whether the standards established under subsection (a) 

6 must be met in their entirety for medical imaging or radi7 ation therapy that is performed in a geographic area that 

8 is determined by the Medicare Geographic Classification 

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

10 as a health professional shortage area. If the Secretary 

11 determines that alternative standards for such rural areas 

12 or health professional shortage areas are appropriate to 

13 assure access to quality medical imaging, the Secretary 

14 is authorized to develop such alternative standards. 

15 ‘‘(j) APPLICABLE TIMELINES.— 

16 ‘‘(1) GENERAL IMPLEMENTATION REGULA17 TIONS.—Not later than 18 months after the date of 

18 enactment of this section, the Secretary shall pro19 mulgate such regulations as may be necessary to im20 plement all standards in this section except those 

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

22 ‘‘(2) MINIMUM STANDARDS FOR CERTIFICATION

23 OF APPROVED BODIES.—Not later than 24 months 

24 after the date of enactment of this section, the Sec25 retary shall establish the standards regarding apVerDate Aug 31 2005 05:14 Dec 06, 2006 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S2322.RS S2322

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1 proved bodies referred to in subsection (d)(2) and 

2 begin certifying approved bodies under such sub3 section. 

4 ‘‘(3) REGULATIONS FOR DELIVERY OF OR PAY5 MENT FOR SERVICES.—Not later than 36 months 

6 after the date of enactment of this section, the Sec7 retary shall promulgate the regulations described in 

8 subsection (h). The Secretary may withhold the pro9 vision of Federal assistance as provided for in sub10 section (h) beginning on the date that is 48 months 

11 after the date of enactment of this section. 

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

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

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

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

16 various mechanisms by which an individual can dem17 onstrate compliance with the standards promulgated 

18 under subsection (a) with respect to performing, 

19 planning, evaluating, or verifying patient dose for 

20 medical imaging or radiation therapy. 

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

22 imaging’ means any procedure used to visualize tis23 sues, organs, or physiologic processes in humans for 

24 the purpose of diagnosing illness or following the 

25 progression of disease. Images may be produced utiVerDate Aug 31 2005 05:14 Dec 06, 2006 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6401 E:\BILLS\S2322.RS S2322

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1 lizing ionizing radiation, radiopharmaceuticals, mag2 netic resonance, or ultrasound and image production 

3 may include the use of contrast media or computer 

4 processing. For purposes of this section, such term 

5 does not include routine dental diagnostic proce6 dures. 

7 ‘‘(3) PERFORM.—The term ‘perform’, with re8 spect to medical imaging or radiation therapy, 

9 means— 

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

11 to radiation via ionizing or radio frequency ra12 diation, to ultrasound, or to a magnetic field for 

13 purposes of medical imaging or for purposes of 

14 radiation therapy; and 

15 ‘‘(B) the act of positioning a patient to re16 ceive such an exposure. 

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

18 medical imaging or radiation therapy, means the act 

19 of preparing for the performance of such a proce20 dure to a patient by evaluating site-specific informa21 tion, based on measurement and verification of radi22 ation dose distribution, computer analysis, or direct 

23 measurement of dose, in order to customize the pro24 cedure for the patient. 


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1 ‘‘(5) 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 radiation.’’. 

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

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

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

9 acting through the Director of the Agency for Healthcare 

10 Research and Quality, shall submit to the Committee on 

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

12 the Committee on Energy and Commerce of the House 

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

14 report shall include the types and numbers of providers 

15 for whom standards have been developed, the impact of 

16 such standards on diagnostic accuracy and patient safety, 

17 and the availability and cost of services. Entities reim18 bursed for technical services through programs operating 

19 under the authority of the Secretary of Health and 

20 Human Services shall be required to contribute data to 

21 such report. 

22 SECTION 1. SHORT TITLE. 

23 This Act may be cited as the ‘‘Consumer Assurance 

24 of Radiologic Excellence Act of 2006’’. 


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1 SEC. 2. PURPOSE. 

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

3 value of healthcare by increasing the safety and accuracy 

4 of medical imaging examinations and radiation therapy 

5 treatments, thereby reducing duplication of services and de6 creasing 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) ESTABLISHMENT OF STANDARDS.— 

16 ‘‘(1) IN GENERAL.—The Secretary, in consulta17 tion with recognized experts in the technical provision 

18 of medical imaging and radiation therapy services, 

19 shall establish standards to ensure the safety and ac20 curacy of medical imaging studies and radiation 

21 therapy treatments. Such standards shall pertain to 

22 the personnel who perform, plan, evaluate, or verify 

23 patient dose for medical imaging studies and radi24 ation therapy procedures and not to the equipment 

25 used. 


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1 ‘‘(2) EXPERTS.—The Secretary shall select expert 

2 advisers under paragraph (1) to reflect a broad and 

3 balanced input from all sectors of the health care com4 munity that are involved in the provision of such 

5 services to avoid undue influence from any single sec6 tor of practice on the content of such standards. 

7 ‘‘(3) LIMITATION.—The Secretary shall not take 

8 any action under this subsection that would require 

9 licensure by a State of those who provide the technical 

10 services referred to in this subsection. 

11 ‘‘(b) EXEMPTIONS.—The standards established under 

12 subsection (a) shall not apply to physicians (as defined in 

13 section 1861(r) of the Social Security Act (42 U.S.C. 

14 1395x(r))), nurse practitioners and physician assistants (as 

15 defined in section 1861(aa)(5) of the Social Security Act 

16 (42 U.S.C. 1395x(aa)(5))). 

17 ‘‘(c) REQUIREMENTS.— 

18 ‘‘(1) IN GENERAL.—Under the standards estab19 lished under subsection (a), the Secretary shall ensure 

20 that individuals, prior to performing or planning 

21 medical imaging and radiation therapy services, dem22 onstrate compliance with the standards established 

23 under subsection (a) through successful completion of 

24 certification by a professional organization, licensure, 

25 completion of an examination, pertinent coursework 


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1 or degree program, verified pertinent experience, or 

2 through other ways determined appropriate by the 

3 Secretary, or through some combination thereof. 

4 ‘‘(2) MISCELLANEOUS PROVISIONS.—The stand5 ards established under subsection (a)— 

6 ‘‘(A) may vary from discipline to dis7 cipline, reflecting the unique and specialized na8 ture of the technical services provided, and shall 

9 represent expert consensus as to what constitutes 

10 excellence in practice and be appropriate to the 

11 particular scope of care involved; 

12 ‘‘(B) may vary in form for each of the cov13 ered disciplines; and 

14 ‘‘(C) may exempt individual providers from 

15 meeting certain standards based on their scope of 

16 practice. 

17 ‘‘(3) RECOGNITION OF INDIVIDUALS WITH EX18 TENSIVE PRACTICAL EXPERIENCE.—For purposes of 

19 this section, the Secretary shall, through regulation, 

20 provide a method for the recognition of individuals 

21 whose training or experience are determined to be 

22 equal to, or in excess of, those of a graduate of an ac23 credited educational program in that specialty, or of 

24 an individual who is regularly eligible to take the liVerDate Aug 31 2005 05:14 Dec 06, 2006 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6203 E:\BILLS\S2322.RS S2322

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1 censure or certification examination for that dis2 cipline. 

3 ‘‘(d) APPROVED BODIES.— 

4 ‘‘(1) IN GENERAL.—Not later than the date de5 scribed in subsection (j)(2), the Secretary shall begin 

6 to certify qualified entities as approved bodies with 

7 respect to the accreditation of the various mechanisms 

8 by which an individual can demonstrate compliance 

9 with the standards promulgated under subsection (a), 

10 if such organizations or agencies meet the standards 

11 established by the Secretary under paragraph (2) and 

12 provide the assurances required under paragraph (3). 

13 ‘‘(2) STANDARDS.—The Secretary shall establish 

14 minimum standards for the certification of approved 

15 bodies under paragraph (1) (including standards for 

16 recordkeeping, the approval of curricula and instruc17 tors, the charging of reasonable fees for certification 

18 or for undertaking examinations, and standards to 

19 minimize the possibility of conflicts of interest), and 

20 other additional standards as the Secretary may re21 quire. 

22 ‘‘(3) ASSURANCES.—To be certified as an ap23 proved body under paragraph (1), an organization or 

24 agency shall provide the Secretary satisfactory assur25 ances that the body will— 


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1 ‘‘(A) be a nonprofit organization; 

2 ‘‘(B) comply with the standards described 

3 in paragraph (2); 

4 ‘‘(C) notify the Secretary in a timely man5 ner if the body fails to comply with the stand6 ards described in paragraph (2); and 

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

8 Secretary may require. 

9 ‘‘(4) WITHDRAWAL OF APPROVAL.— 

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

11 withdraw the certification of an approved body 

12 if the Secretary determines the body does not 

13 meet the standards under paragraph (2). 

14 ‘‘(B) EFFECT OF WITHDRAWAL.—The with15 drawal of the certification of an approved body 

16 under subparagraph (A) shall have no effect on 

17 the certification status of any individual or per18 son that was certified by that approved body 

19 prior to the date of such withdrawal. 

20 ‘‘(e) EXISTING STATE STANDARDS.—Standards estab21 lished by a State for the licensure or certification of per22 sonnel, accreditation of educational programs, or adminis23 tration of examinations shall be deemed to be in compliance 

24 with the standards of this section unless the Secretary deter25 mines that such State standards do not meet the minimum 


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1 standards prescribed by the Secretary or are inconsistent 

2 with the purposes of this section. The Secretary shall estab3 lish a process by which a State may respond to or appeal 

4 a determination made by the Secretary under the preceding 

5 sentence. 

6 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec7 tion shall be construed to prohibit a State or other approved 

8 body from requiring compliance with a higher standard of 

9 education and training than that specified by this section. 

10 Notwithstanding any other provision of this section, indi11 viduals who provide medical imaging services relating to 

12 mammograms shall continue to meet the standards applica13 ble under the Mammography Quality Standards Act of 

14 1992. 

15 ‘‘(g) EVALUATION AND REPORT.—The Secretary shall 

16 periodically evaluate the performance of each approved 

17 body under subsection (d) at an interval determined appro18 priate by the Secretary. The results of such evaluations shall 

19 be included as part of the report submitted to the Committee 

20 on Health, Education, Labor, and Pensions of the Senate 

21 and the Committee on Energy and Commerce of the House 

22 of Representatives in accordance with 354(e)(6)(B). 

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

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

25 Secretary shall promulgate regulations to ensure that all 


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1 programs under the authority of the Secretary that involve 

2 the performance of or payment for medical imaging or radi3 ation therapy, are performed in accordance with the stand4 ards established under this section. 

5 ‘‘(i) ALTERNATIVE STANDARDS FOR RURAL AND UN6 DERSERVED AREAS.— 

7 ‘‘(1) IN GENERAL.—The Secretary shall deter8 mine whether the standards established under sub9 section (a) must be met in their entirety for medical 

10 imaging or radiation therapy that is performed in a 

11 geographic area that is determined by the Medicare 

12 Geographic Classification Review Board to be a ‘rural 

13 area’ or that is designated as a health professional 

14 shortage area. If the Secretary determines that alter15 native standards for such rural areas or health profes16 sional shortage areas are appropriate to assure access 

17 to quality medical imaging, the Secretary is author18 ized to develop such alternative standards. 

19 ‘‘(2) STATE DISCRETION.—The chief executive of20 ficer of a State may submit to the Secretary a state21 ment declaring that an alternative standard devel22 oped under paragraph (1) is inappropriate for appli23 cation to such State, and such alternative standard 

24 shall not apply in such submitting State. The chief 

25 executive officer of a State may rescind a statement 


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1 described in this paragraph following the provision of 

2 appropriate notice to the Secretary. 

3 ‘‘(j) APPLICABLE TIMELINES.— 

4 ‘‘(1) GENERAL IMPLEMENTATION REGULA5 TIONS.—Not later than 18 months after the date of 

6 enactment of this section, the Secretary shall promul7 gate such regulations as may be necessary to imple8 ment all standards in this section except those pro9 vided for in subsection (d)(2). 

10 ‘‘(2) MINIMUM STANDARDS FOR CERTIFICATION

11 OF APPROVED BODIES.—Not later than 24 months 

12 after the date of enactment of this section, the Sec13 retary shall establish the standards regarding ap14 proved bodies referred to in subsection (d)(2) and 

15 begin certifying approved bodies under such sub16 section. 

17 ‘‘(3) REGULATIONS FOR DELIVERY OF OR PAY18 MENT FOR SERVICES.—Not later than 36 months after 

19 the date of enactment of this section, the Secretary 

20 shall promulgate the regulations described in sub21 section (h). The Secretary may withhold the provision 

22 of Federal assistance as provided for in subsection (h) 

23 beginning on the date that is 48 months after the date 

24 of enactment of this section. 

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


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

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

3 Secretary under subsection (d)(1) to accredit the var4 ious mechanisms by which an individual can dem5 onstrate compliance with the standards promulgated 

6 under subsection (a) with respect to performing, plan7 ning, evaluating, or verifying patient dose for medical 

8 imaging or radiation therapy. 

9 ‘‘(2) MEDICAL IMAGING.—The term ‘medical im10 aging’ means any procedure used to visualize tissues, 

11 organs, or physiologic processes in humans for the 

12 purpose of diagnosing illness or following the progres13 sion of disease. Images may be produced utilizing ion14 izing radiation, radiopharmaceuticals, magnetic reso15 nance, or ultrasound and image production may in16 clude the use of contrast media or computer proc17 essing. For purposes of this section, such term does 

18 not include routine dental diagnostic procedures. 

19 ‘‘(3) PERFORM.—The term ‘perform’, with re20 spect to medical imaging or radiation therapy, 

21 means— 

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

23 to radiation via ionizing or radio frequency ra24 diation, to ultrasound, or to a magnetic field for 


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1 purposes of medical imaging or for purposes of 

2 radiation therapy; and 

3 ‘‘(B) the act of positioning a patient to re4 ceive such an exposure. 

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

6 medical imaging or radiation therapy, means the act 

7 of preparing for the performance of such a procedure 

8 to a patient by evaluating site-specific information, 

9 based on measurement and verification of radiation 

10 dose distribution, computer analysis, or direct meas11 urement of dose, in order to customize the procedure 

12 for the patient. 

13 ‘‘(5) RADIATION THERAPY.—The term ‘radiation 

14 therapy’ means any procedure or article intended for 

15 use in the cure, mitigation, treatment, or prevention 

16 of disease in humans that achieves its intended pur17 pose through the emission of radiation. 

18 ‘‘(l) SUNSET.—This section shall have no force or effect 

19 after September 30, 2016.’’. 

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

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

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

23 acting through the Director of the Agency for Healthcare 

24 Research and Quality, shall submit to the Committee on 

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


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1 the Committee on Energy and Commerce of the House of 

2 Representatives a report on the effects of this Act. Such re3 port shall include the types and numbers of providers for 

4 whom standards have been developed, the impact of such 

5 standards on diagnostic accuracy and patient safety, and 

6 the availability and cost of services. Entities reimbursed for 

7 technical services through programs operating under the au8 thority of the Secretary of Health and Human Services 

9 shall be required to contribute data to such report. 


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hmoore on PROD1PC68 with HMBILLS
Calendar No. 668 

109TH CONGRESS 

2D SESSION S. 2322 

[Report No. 109

–363] 

A BILL 

To amend the Public Health Service Act to make 

ments safer, more accurate, and less costly. aging examinations and radiation therapy treatthe provision of technical services for medical imDECEMBER 5, 2006 

Reported with an amendment 


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