109TH CONGRESS

2D SESSION S. 2322

AN ACT

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’’.
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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

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) ESTABLISHMENT OF STANDARDS.—

16 ‘‘(1) IN GENERAL.—The Secretary, in consulta17 tion with recognized experts in the technical provi18 sion of medical imaging and radiation therapy serv19 ices, shall establish standards to ensure the safety

20 and accuracy of medical imaging studies and radi21 ation therapy treatments. Such standards shall per22 tain to the personnel who perform, plan, evaluate, or

23 verify patient dose for medical imaging studies and

24 radiation therapy procedures and not to the equip25 ment used.
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1 ‘‘(2) EXPERTS.—The Secretary shall select ex2 pert advisers under paragraph (1) to reflect a broad

3 and balanced input from all sectors of the health

4 care community that are involved in the provision of

5 such services to avoid undue influence from any sin6 gle sector of practice on the content of such stand7 ards.

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

9 take any action under this subsection that would re10 quire licensure by a State of those who provide the

11 technical services referred to in this subsection.

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

13 under subsection (a) shall not apply to physicians (as de14 fined in section 1861(r) of the Social Security Act (42

15 U.S.C. 1395x(r))), nurse practitioners and physician as16 sistants (as defined in section 1861(aa)(5) of the Social

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

18 ‘‘(c) REQUIREMENTS.—

19 ‘‘(1) IN GENERAL.—Under the standards estab20 lished under subsection (a), the Secretary shall en21 sure that individuals, prior to performing or plan22 ning medical imaging and radiation therapy services,

23 demonstrate compliance with the standards estab24 lished under subsection (a) through successful com25 pletion of certification by a professional organiza-
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1 tion, licensure, completion of an examination, perti2 nent coursework or degree program, verified perti3 nent experience, or through other ways determined

4 appropriate by the Secretary, or through some com5 bination thereof.

6 ‘‘(2) MISCELLANEOUS PROVISIONS.—The

7 standards established under subsection (a)—

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

9 reflecting the unique and specialized nature of

10 the technical services provided, and shall rep11 resent expert consensus as to what constitutes

12 excellence in practice and be appropriate to the

13 particular scope of care involved;

14 ‘‘(B) may vary in form for each of the cov15 ered disciplines; and

16 ‘‘(C) may exempt individual providers from

17 meeting certain standards based on their scope

18 of practice.

19 ‘‘(3) RECOGNITION OF INDIVIDUALS WITH EX20 TENSIVE PRACTICAL EXPERIENCE.—For purposes of

21 this section, the Secretary shall, through regulation,

22 provide a method for the recognition of individuals

23 whose training or experience are determined to be

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

25 accredited educational program in that specialty, or
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1 of an individual who is regularly eligible to take the

2 licensure or certification examination for that dis3 cipline.

4 ‘‘(d) APPROVED BODIES.—

5 ‘‘(1) IN GENERAL.—Not later than the date de6 scribed in subsection (j)(2), the Secretary shall begin

7 to certify qualified entities as approved bodies with

8 respect to the accreditation of the various mecha9 nisms by which an individual can demonstrate com10 pliance with the standards promulgated under sub11 section (a), if such organizations or agencies meet

12 the standards established by the Secretary under

13 paragraph (2) and provide the assurances required

14 under paragraph (3).

15 ‘‘(2) STANDARDS.—The Secretary shall estab16 lish minimum standards for the certification of ap17 proved bodies under paragraph (1) (including stand18 ards for recordkeeping, the approval of curricula and

19 instructors, the charging of reasonable fees for cer20 tification or for undertaking examinations, and

21 standards to minimize the possibility of conflicts of

22 interest), and other additional standards as the Sec23 retary may require.

24 ‘‘(3) ASSURANCES.—To be certified as an ap25 proved body under paragraph (1), an organization or
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1 agency shall provide the Secretary satisfactory as2 surances that the body will—

3 ‘‘(A) be a nonprofit organization;

4 ‘‘(B) comply with the standards described

5 in paragraph (2);

6 ‘‘(C) notify the Secretary in a timely man7 ner if the body fails to comply with the stand8 ards described in paragraph (2); and

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

10 Secretary may require.

11 ‘‘(4) WITHDRAWAL OF APPROVAL.—

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

13 withdraw the certification of an approved body

14 if the Secretary determines the body does not

15 meet the standards under paragraph (2).

16 ‘‘(B) EFFECT OF WITHDRAWAL.—The

17 withdrawal of the certification of an approved

18 body under subparagraph (A) shall have no ef19 fect on the certification status of any individual

20 or person that was certified by that approved

21 body prior to the date of such withdrawal.

22 ‘‘(e) EXISTING STATE STANDARDS.—Standards es23 tablished by a State for the licensure or certification of

24 personnel, accreditation of educational programs, or ad25 ministration of examinations shall be deemed to be in com-
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1 pliance with the standards of this section unless the Sec2 retary determines that such State standards do not meet

3 the minimum standards prescribed by the Secretary or are

4 inconsistent with the purposes of this section. The Sec5 retary shall establish a process by which a State may re6 spond to or appeal a determination made by the Secretary

7 under the preceding sentence.

8 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec9 tion shall be construed to prohibit a State or other ap10 proved body from requiring compliance with a higher

11 standard of education and training than that specified by

12 this section. Notwithstanding any other provision of this

13 section, individuals who provide medical imaging services

14 relating to mammograms shall continue to meet the stand15 ards applicable under the Mammography Quality Stand16 ards Act of 1992.

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

18 shall periodically evaluate the performance of each ap19 proved body under subsection (d) at an interval deter20 mined appropriate by the Secretary. The results of such

21 evaluations shall be included as part of the report sub22 mitted to the Committee on Health, Education, Labor,

23 and Pensions of the Senate and the Committee on Energy

24 and Commerce of the House of Representatives in accord25 ance with 354(e)(6)(B).
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1 ‘‘(h) DELIVERY OF AND PAYMENT FOR SERVICES.—

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

3 Secretary shall promulgate regulations to ensure that all

4 programs under the authority of the Secretary that involve

5 the performance of or payment for medical imaging or ra6 diation therapy, are performed in accordance with the

7 standards established under this section.

8 ‘‘(i) ALTERNATIVE STANDARDS FOR RURAL AND UN9 DERSERVED AREAS.—

10 ‘‘(1) IN GENERAL.—The Secretary shall deter11 mine whether the standards established under sub12 section (a) must be met in their entirety for medical

13 imaging or radiation therapy that is performed in a

14 geographic area that is determined by the Medicare

15 Geographic Classification Review Board to be a

16 ‘rural area’ or that is designated as a health profes17 sional shortage area. If the Secretary determines

18 that alternative standards for such rural areas or

19 health professional shortage areas are appropriate to

20 assure access to quality medical imaging, the Sec21 retary is authorized to develop such alternative

22 standards.

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

24 officer of a State may submit to the Secretary a

25 statement declaring that an alternative standard de-
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1 veloped under paragraph (1) is inappropriate for ap2 plication to such State, and such alternative stand3 ard shall not apply in such submitting State. The

4 chief executive officer of a State may rescind a

5 statement described in this paragraph following the

6 provision of appropriate notice to the Secretary.

7 ‘‘(j) APPLICABLE TIMELINES.—

8 ‘‘(1) GENERAL IMPLEMENTATION REGULA9 TIONS.—Not later than 18 months after the date of

10 enactment of this section, the Secretary shall pro11 mulgate such regulations as may be necessary to im12 plement all standards in this section except those

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

14 ‘‘(2) MINIMUM STANDARDS FOR CERTIFICATION

15 OF APPROVED BODIES.—Not later than 24 months

16 after the date of enactment of this section, the Sec17 retary shall establish the standards regarding ap18 proved bodies referred to in subsection (d)(2) and

19 begin certifying approved bodies under such sub20 section.

21 ‘‘(3) REGULATIONS FOR DELIVERY OF OR PAY22 MENT FOR SERVICES.—Not later than 36 months

23 after the date of enactment of this section, the Sec24 retary shall promulgate the regulations described in

25 subsection (h). The Secretary may withhold the pro-
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1 vision of Federal assistance as provided for in sub2 section (h) beginning on the date that is 48 months

3 after the date of enactment of this section.

4 ‘‘(k) DEFINITIONS.—In this section:

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

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

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

8 various mechanisms by which an individual can dem9 onstrate compliance with the standards promulgated

10 under subsection (a) with respect to performing,

11 planning, evaluating, or verifying patient dose for

12 medical imaging or radiation therapy.

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

14 imaging’ means any procedure used to visualize tis15 sues, organs, or physiologic processes in humans for

16 the purpose of diagnosing illness or following the

17 progression of disease. Images may be produced uti18 lizing ionizing radiation, radiopharmaceuticals, mag19 netic resonance, or ultrasound and image production

20 may include the use of contrast media or computer

21 processing. For purposes of this section, such term

22 does not include routine dental diagnostic proce23 dures.
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1 ‘‘(3) PERFORM.—The term ‘perform’, with re2 spect to medical imaging or radiation therapy,

3 means—

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

5 to radiation via ionizing or radio frequency ra6 diation, to ultrasound, or to a magnetic field for

7 purposes of medical imaging or for purposes of

8 radiation therapy; and

9 ‘‘(B) the act of positioning a patient to re10 ceive such an exposure.

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

12 medical imaging or radiation therapy, means the act

13 of preparing for the performance of such a proce14 dure to a patient by evaluating site-specific informa15 tion, based on measurement and verification of radi16 ation dose distribution, computer analysis, or direct

17 measurement of dose, in order to customize the pro18 cedure for the patient.

19 ‘‘(5) RADIATION THERAPY.—The term ‘radi20 ation therapy’ means any procedure or article in21 tended for use in the cure, mitigation, treatment, or

22 prevention of disease in humans that achieves its in23 tended purpose through the emission of radiation.

24 ‘‘(l) SUNSET.—This section shall have no force or ef25 fect after September 30, 2016.’’.
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1 SEC. 4. REPORT ON THE EFFECTS OF THIS ACT.

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

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

4 acting through the Director of the Agency for Healthcare

5 Research and Quality, shall submit to the Committee on

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

7 the Committee on Energy and Commerce of the House

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

9 report shall include the types and numbers of providers

10 for whom standards have been developed, the impact of

11 such standards on diagnostic accuracy and patient safety,

12 and the availability and cost of services. Entities reim13 bursed for technical services through programs operating

14 under the authority of the Secretary of Health and

15 Human Services shall be required to contribute data to

16 such report.

Passed the Senate December 6, 2006.

Attest:

Secretary.
109TH CONGRESS

2D SESSION S. 2322

AN ACT

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 im-