[Senate Report 109-363]
[From the U.S. Government Publishing Office]



                                                       Calendar No. 668
109th Congress                                                   Report
                                 SENATE
 2d Session                                                     109-363

======================================================================



 
        CONSUMER ASSURANCE OF RADIOLOGIC EXCELLENCE ACT OF 2006

                                _______
                                

                December 5, 2006.--Ordered to be printed

                                _______
                                

Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions, 
                        submitted the following

                              R E P O R T

                         [To accompany S. 2322]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (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, having 
considered the same, reports favorably thereon with an 
amendment and recommends that the bill (as amended) do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Need for Legislation.................................1
 II. Summary..........................................................2
III. History of Legislation and Votes in Committee....................3
 IV. Explanation of Bill and Committee Views..........................3
  V. Congressional Budget Office Cost Estimate........................4
 VI. Regulatory Impact Statement......................................7
VII. Application of Law to the Legislative Branch.....................7
VIII.Section-by-Section Analysis......................................7

 IX. Changes in Existing Law..........................................8

                  I. Purpose and Need for Legislation

    The Consumer Assurance of Radiologic Excellence (CARE) Act 
would establish national standards for the education, training, 
and credentialing of those technical providers who work 
directly with patients to obtain diagnostic medical images or 
deliver therapeutic radiation. Patients and providers alike 
will benefit from more efficient and accurate diagnoses and 
safer, more appropriate therapies, all afforded at a 
substantially decreased cost to the taxpayer.
    Cancer of many different types has become much more common; 
behind only heart disease, cancer is the second leading cause 
of death in America. Medical imaging tests play an increasingly 
important role in diagnosing a wide variety of malignant 
diseases and in determining the results of treatment. Radiation 
therapy is a common form of cancer therapy and used in more 
than half of all cancer cases. As the population ages, we 
should anticipate that such procedures and therapies will be 
performed with greater frequency on older Americans, with the 
cost borne more and more often by federally financed health 
care programs. For example, in 2004, Medicare paid over $1 
billion for radiation therapy.
    Improvements in healthcare often occur through 
technological innovations. For example, today's providers 
depend much more on diagnostic medical imaging than they did in 
the past, which has led to explosive number of procedures 
performed, procedures that are not limited just to patients 
with cancer. Over 300 million radiologic procedures are 
performed annually in the United States, with 70 percent of 
Americans undergoing some type of medical imaging exam or 
radiation therapy treatment annually. These innovations, while 
of undeniable potential benefit, come with substantial costs. 
Radiology costs are reaching over $100 billion annually; 
diagnostic imaging is one of the fastest growing cost areas in 
American healthcare.
    Congress has already taken some steps to assure the public 
that those who provide these services meet sufficient standards 
of technical proficiency. The Mammography Quality Standards Act 
of 1992 established standards for technologists performing one 
crucial diagnostic test; substantial quality improvement has 
been the result. The Consumer-Patient Radiation Health and 
Safety Act of 1981 encouraged the States to set standards for 
the technical competence of those who provide diagnostic 
imaging or radiation therapy services to patients, but left 
compliance with those standards optional. Unfortunately, to 
date, nine States and the District of Columbia have enacted no 
regulatory statutes at all while, in a further six States, 
those regulations remain incomplete. Some provider disciplines 
have no specified standards of education, training and 
experience at all. In fact, a provider with only a few hours of 
course work or a couple of weeks of on-the-job training may be 
responsible for obtaining the image a physician uses to 
diagnose your cancer or to deliver the radiation that is 
crucial to the treatment of a tumor.
    In a June 2005 report to Congress, MedPAC--the Medicare 
Payment and Advisory Commission--recognized that, while the 
issue is complex, technical excellence in diagnostic imaging 
and radiation therapy plays a central role in improving the 
public health and lowering costs of care. The CARE Act seeks to 
implement those recommendations that speak to credentialing of 
technical providers and brings to completion work begun with 
the Consumer-Patient Radiation Health and Safety Act.

                              II. Summary

    Consumer Assurance of Radiologic Excellence Act of 2006--
Amends the Public Health Service Act to direct the Secretary of 
Health and Human Services to establish standards to assure the 
safety and accuracy of medical imaging or radiation therapy. 
Such standards shall pertain to the personnel who perform, 
plan, evaluate, or verify patient dose for medical imaging 
studies and radiation therapy procedures and not the equipment 
they use.

           III. History of Legislation and Votes in Committee

    On February 17, 2006, Senators ENZI and KENNEDY introduced 
S. 2322, the ``Consumer Assurance of Radiologic Excellence Act 
of 2006.'' On September 20, 2006, the committee held an 
executive session to consider S. 2322. The committee approved 
by unanimous consent a manager's amendment to S. 2322. Senators 
KENNEDY and ISAKSON cosponsored the manager's amendment.
    During the 107th Congress, Senators ENZI and KENNEDY 
introduced S. 1197, the Consumer Assurance of Radiologic 
Excellence Act of 2003 on June 5, 2003. The bill was referred 
to the Senate Health, Education, Labor, and Pensions Committee. 
No further action was taken.

              IV. Explanation of Bill and Committee Views

    The Centers for Medicare and Medicaid Services (CMS) and 
private payers alike have documented that imaging utilization 
and spending are growing at a rate faster than other health 
care expenditures. Demand grows for medical imaging as the 
``Baby Boom'' generation continues to age and dramatic 
scientific and technical advances are made.
    Technical providers are an integral part of medical imaging 
and radiation therapy treatments. An imaging procedure may be 
performed at the request of a physician if a physician feels it 
necessary to aid in the patient's diagnosis. There are two 
components to the procedure--the exam itself and the 
radiologist's interpretation. The imaging exam is referred to 
as the technical component. Nine States and the District of 
Columbia do not have any standards for the technical competence 
of those who provide diagnostic imaging or radiation therapy, 
while in six States, those regulations remain incomplete. The 
committee believes standards for the health care professionals 
will only add to the overall quality of care of patients. The 
intent of the legislation is not to overturn effective State 
standards already in place but rather to see that the benefits 
of having effective standards are extended to those States in 
which such standards are not currently in effect. To ensure 
that effective State standards are not improperly overturned by 
the legislation, the bill provides for an appeal process 
through which a State may respond to any contention by the 
Secretary of Health and Human Services that such State lacks 
standards that meet the Federal minimum established by the act.
    The committee recognizes many technicians already undergo 
some type of credentialing through specialty society or are 
required by the State. To complement and not interfere with 
credentialing already required in some States, the committee 
views it necessary that the standards set by the HHS Secretary 
aim to establish the minimum standards for each type of 
technical provider for radiologic imaging or radiation 
therapist. The committee also recognizes the varying 
disciplines that require medical imaging. Thus the legislation 
is flexible to ensure each scope of practice has recognized 
experts who are consulted by the Secretary about the minimum 
standards that will be established. By doing so, the unique 
aspects of various radiologic procedures will be considered.
    There are five different ways the technical providers can 
attain the standards promulgated by the Secretary including the 
``recognition of verified pertinent work experience.'' The 
committee does not want to disenfranchise individuals currently 
practicing as medical imaging professionals or Radiation 
Therapists who have experience that could reasonably be 
substituted for the credentialing standards called for in this 
legislation. For this reason, the bill includes language 
authorizing the Secretary to develop a process by which 
individuals, who are practicing at the time of the enactment of 
this legislation, can be grandfathered into the standards the 
Secretary is charged with developing. The years of experience 
these individuals have developed can be reasonably substituted 
for the credentialing standards anticipated by this bill. 
However, that work experience should be relatively current. By 
this we mean that individuals should be practicing as medical 
imaging professionals or Radiation Therapists for a minimum of 
3 of the previous 5 years prior to enactment of this bill.
    We note that the process for developing the standards and 
implementing the standards will afford individuals not 
currently credentialed as medical imaging professionals or 
Radiation Therapists several years to become credentialed prior 
to enforcement of these standards. Therefore, individuals who 
are unable to obtain the necessary credential, but who meet the 
experience requirements, should seek recognition under the 
grandfather clause within a reasonable time period after 
enactment of the legislation. We recommend that the Secretary 
only consider requests for recognition under the grandfathering 
process for 2 years after the date when enforcement of the 
standards begins.
    Under this arrangement, individuals not credentialed at the 
time of enactment of the legislation will have 4 years to 
obtain the necessary credential prior to enforcement and an 
additional 2 years to apply for recognition based upon the 
experience requirements set by the Secretary.
    The committee expects the Secretary to establish standards 
in consultation with experts in the medical imaging field 
within 18 months of enactment. Within 24 months, the standards 
of certification of approved bodies shall be set, and such 
regulations shall be promulgated within 36 months. The 
Secretary may withhold Federal Assistance if standards are not 
met by a State within 48 months of enactment.
    It is the committee's intent that individuals who provide 
medical imaging services relating to mammograms will continue 
to meet standards enacted by the Mammography Quality Standards 
Act of 1992.

              V. Congressional Budget Office Cost Estimate


S. 2322--Consumer Assurance of Radiologic Excellence Act of 2006

    Summary: S. 2322 would amend the Public Health Service Act 
to require that the Secretary of Health and Human Services 
(HHS) establish national educational and credentialing 
standards for technologists who perform certain medical-imaging 
studies and procedures involving radiation therapy. The new 
federal standards would not pertain to equipment or to 
physicians, nurse practitioners, or physician assistants. All 
standards established under the bill would expire on September 
30, 2016.
    CBO estimates that implementing S. 2322 would result in 
additional discretionary spending of $2 million in 2007 and 
about $20 million over the 2007-2011 period, assuming the 
appropriation of the necessary amounts. CBO estimates that 
establishing national standards for technologists would have a 
negligible effect on direct spending. Enacting S. 2322 would 
not affect revenues.
    S. 2322 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA). 
Although it would add new requirements for individuals who 
provide medical-imaging or radiation-therapy services in 
federally supported medical programs, S. 2322 would not preempt 
state laws that require individuals to be licensed or 
certified. Because the requirements of S. 2322 on individuals 
are only enforceable under government programs in which 
participation is voluntary, such requirements are considered 
conditions of participation in those programs.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of S. 2322 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                       By fiscal year, in millions of dollars--
                                                                    --------------------------------------------
                                                                       2007     2008     2009     2010     2011
----------------------------------------------------------------------------------------------------------------
                                CHANGES IN SPENDING SUBJECT TO APPROPRIATION \1\

Estimated Authorization Level......................................        2        3        5        5        6
Estimated Outlays..................................................        2        3        4        5       6
----------------------------------------------------------------------------------------------------------------
\1\ Enacting S. 2322 also could affect direct spending, but CBO expects that any such changes would be
  negligible.

Basis of estimate

            Spending subject to appropriation
    For this estimate, CBO assumes that S. 2322 will be enacted 
near the start of fiscal year 2007 and that the amounts 
necessary to implement the bill will be appropriated for each 
year.
    National Standards for Selected Technologists Under S. 
2322. S. 2322 would require the Secretary of HHS to establish 
educational and credentialing standards for technical personnel 
who perform, plan, evaluate, or verify dosing for medical 
imaging services and procedures involving radiation therapy. 
Medical imaging refers to any procedure used to visualize 
tissues, organs, or physiologic processes in humans for 
diagnosing illness or monitoring the progression of disease. 
Radiation therapy uses the emission of radiation for treating 
or preventing disease. (The new standards would not apply to 
certain routine dental procedures, and they would not pertain 
to equipment or to physicians, nurse practitioners, or 
physician assistants.)
    S. 2322 also would require the Secretary to certify 
qualified entities as approved bodies for administering 
standards and accrediting the various ways a technologist could 
demonstrate compliance. All of the standards established under 
this legislation would expire on September 30, 2016.
    Enforcement Authority. S. 2322 would require the Secretary 
to ensure that individuals, prior to performing or planning 
specified services, demonstrate compliance with the new 
standards. The bill would require all HHS programs that perform 
or pay for medical imaging services or radiation therapy to 
comply with such standards. It also would give the Secretary 
discretion to withhold payment by HHS programs for services 
furnished by technologists who are not certified.
    Other Provisions. The bill would authorize the Secretary to 
develop alternative standards for rural areas or other 
underserved areas if necessary to assure access to quality 
health care. It would also require the Agency for Healthcare 
Research and Quality to conduct a study on the effect of the 
new federal standards on diagnostic accuracy, patient safety, 
and the availability and cost of services.
    Administrative Costs to Implement S. 2322. S. 2322 does not 
specify which agency within HHS would administer the new 
standards. CBO assumes that the Food and Drug Administration 
(FDA) would coordinate with the Centers for Medicare & Medicaid 
Services (CMS) and the Health Services and Resources 
Administration to implement the bill. Given the uncertainty 
surrounding how the Secretary would develop and enforce the new 
standards, it is difficult to estimate the total resources 
necessary to administer such activities.
    Within a few years of enactment, CBO expects that the total 
costs to administer the new standards for technologists could 
reach between one-third and one-half of FDA's estimated costs 
to operate its existing quality assurance program for 
mammography (excluding costs funded through user fees primarily 
for activities related to the inspections of facilities). We 
estimate that implementing S. 2322 would result in additional 
discretionary outlays of $2 million in 2007 and about $20 
million over the 2007-2011 period, assuming the appropriation 
of the necessary amounts. Although S. 2322 would apply 
standards to a broader array of technical personnel than does 
the mammography program, CBO expects that FDA's costs would be 
lower for the new program because the new standards would apply 
only to technologists and not to equipment, facilities, or 
other practitioners as does the mammography program.
            Direct spending
    S. 2322 would allow the Secretary of HHS to withhold 
``federal assistance'' from noncompliant providers who 
participate in health programs under the Secretary's 
jurisdiction. Vigorous enforcement of educational and 
credentialing standards for certain technologists under the 
bill could reduce spending by health programs such as Medicare 
and Medicaid.
    Expanding federal standards for such personnel could 
improve the diagnostic accuracy of imaging tests and reduce the 
number of images services paid by those programs. However, 
based on information provided by CMS, CBO expects that it is 
unlikely that the Secretary would choose to withhold payments 
to enforce compliance. Therefore, CBO expects that expanding 
national standards would not substantially change how Medicare 
and Medicaid operate, and as a result, probably would not have 
a significant effect on spending in those programs.
    Estimated impact on state, local, and tribal governments: 
Although it would add new requirements for individuals who 
provide medical imaging or radiation therapy services through 
medical programs that are federally supported, S. 2322 would 
not preempt state laws that require individuals to be licensed 
or certified. Consequently, the bill does not contain an 
intergovernmental mandate as defined in the UMRA. State 
procedures for licensing or certifying those individuals may be 
deemed sufficient for meeting the new federal standards. If 
they are not, states may appeal the decision. Nothing in the 
bill would require states to implement higher standards in 
their own law, but in order for individuals to be qualified to 
act as medical imaging or radiation therapy personnel in most 
cases, they would have to meet the new federal standards as 
well--possibly through an accredited nonprofit organization.
    Estimated impact on the private sector: S. 2322 also 
contains no private-sector mandates as defined in UMRA. The 
Secretary of the Department of Health and Human Services would 
be given authority to enforce the requirements of S. 2322 by 
withholding federal assistance. The requirements created are 
considered conditions of participation, because they are only 
enforceable under government programs in which participation is 
voluntary.
    Estimate prepared by: Federal Costs: Julia Christensen, 
Geoff Gerhardt, and Camile Williams. Impact on State, Local, 
and Tribal Governments: Leo Lex. Impact on the Private Sector: 
Peter Richmond.
    Estimate approved by: Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                    VI. Regulatory Impact Statement

    Pursuant to the requirements of paragraph 11(b) of rule 
XXVI of the Standing Rules of the Senate, the committee has 
determined that the bill will not have a significant regulatory 
impact.

           VII. Application of Law to the Legislative Branch

    The committee has determined that there is not impact of 
this law on the legislative branch.

                   VIII. Section-by-Section Analysis


Section 1. Short title

    The Short Title of the bill is the Consumer Assurance of 
Radiologic Excellence Act of 2006.

Section 2. Purpose

    The purpose of the bill is to improve the quality and value 
of healthcare by increasing the safety and accuracy of medical 
imaging examination and radiation therapy treatments.

Section 3. Quality of medical imaging and radiation therapy

    Section 3 authorizes the Secretary, in consultation with 
recognized experts in the technical provision of medical 
imaging and radiation therapy services, to establish standards 
for personnel who perform, plan, evaluate or verify patient 
dose for medical imaging studies and radiation therapy 
procedures.
    Standards do not pertain to equipment used or physicians, 
nurse practitioners or physician assistants.
    The Secretary shall ensure that individuals, prior to 
performing or planning medical imaging and radiation therapy 
services, demonstrate compliance with the standards established 
through various mechanisms:
     successful completion of certification by a 
professional organization,
     licensure,
     completion of an examination,
     pertinent coursework or degree program, and
     verified pertinent experience.
    The Secretary shall certify qualified entities as approved 
bodies for accreditation and establish minimum standards for 
certification of approved bodies. Periodic evaluation of their 
performance will be submitted as part of a report to the 
Health, Education, Labor, and Pensions Committee and the 
Committee on Energy and Commerce.
    Standards established by a State for the licensure or 
certification of personnel, accreditation of educational 
programs, or administration of examinations shall be deemed to 
be in compliance with the standards of this section unless the 
Secretary determines that such State standards do not meet the 
minimum standards. A State may appeal the Secretary's 
determination that it does not meet the minimum standards. 
Alternative standards for rural and health professional 
shortage areas will be set by the Secretary that will assure 
access to quality medical imaging. A chief-elected official may 
decide whether or not the use of alternatives standards is 
appropriate.
    This section provides a timeline for implementation after 
enactment:
     Establish standards within 18 months.
     Establish standards of Certification of approved 
bodies within 24 months.
     Promulgate regulations within 36 months.
     Secretary may withhold the provision of Federal 
assistance within 48 months.
    A sunset provision requires the legislation to expire on 
September 30, 2016.

Section 4. Report on the effects of this act

    This section requires the Secretary acting through the 
Director of the Agency for Healthcare Research and Quality to 
submit a report to the Committee on Health, Education, Labor, 
and Pensions and the Energy and Commerce Committee through the 
Agency not later than 5 years after the date of enactment. The 
report shall include the types and number of providers who have 
developed standards and an update of standards on diagnosis 
accuracy, patient safety, availability and costs of services.

                      IX. Changes in Existing Law

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (existing law proposed to be omitted is enclosed in 
black brackets, new matter is printed in italic, existing law 
in which no change is proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *


     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

PART A--RESEARCH AND INVESTIGATION

           *       *       *       *       *       *       *



    PART F--LICENSING--BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES


                     Subpart 1--Biological Products


                 REGULATION OF BIOLOGICAL PRODUCTS \2\

    Sec. 351. (a)(1) * * *

           *       *       *       *       *       *       *


                   Subpart 3--Mammography Facilities


SEC. 354. CERTIFICATION OF MAMMOGRAPHY FACILITIES.

    (a) Definitions.--* * *

           *       *       *       *       *       *       *


            Subpart 4--Medical Imaging and Radiation Therapy

SEC. 355. QUALITY OF MEDICAL IMAGING AND RADIATION THERAPY.

    (a) Establishment of Standards.--
          (1) In general.--The Secretary, in consultation with 
        recognized experts in the technical provision of 
        medical imaging and radiation therapy services, shall 
        establish standards to ensure the safety and accuracy 
        of medical imaging studies and radiation therapy 
        treatments. Such standards shall pertain to the 
        personnel who perform, plan, evaluate, or verify 
        patient dose for medical imaging studies and radiation 
        therapy procedures and not to the equipment used.
          (2) Experts.--The Secretary shall select expert 
        advisers under paragraph (1) to reflect a broad and 
        balanced input from all sectors of the health care 
        community that are involved in the provision of such 
        services to avoid undue influence from any single 
        sector of practice on the content of such standards.
          (3) Limitation.--The Secretary shall not take any 
        action under this subsection that would require 
        licensure by a State of those who provide the technical 
        services referred to in this subsection.
    (b) Exemptions.--The standards established under subsection 
(a) shall not apply to physicians (as defined in section 
1861(r) of the Social Security Act (42 U.S.C. 1395x(r))), nurse 
practitioners and physician assistants (as defined in section 
1861(aa)(5) of the Social Security Act (42 U.S.C. 
1395x(aa)(5))).
    (c) Requirements.--
          (1) In general.--Under the standards established 
        under subsection (a), the Secretary shall ensure that 
        individuals, prior to performing or planning medical 
        imaging and radiation therapy services, demonstrate 
        compliance with the standards established under 
        subsection (a) through successful completion of 
        certification by a professional organization, 
        licensure, completion of an examination, pertinent 
        coursework or degree program, verified pertinent 
        experience, or through other ways determined 
        appropriate by the Secretary, or through some 
        combination thereof.
          (2) Miscellaneous provisions.--The standards 
        established under subsection (a)--
                  (A) may vary from discipline to discipline, 
                reflecting the unique and specialized nature of 
                the technical services provided, and shall 
                represent expert consensus as to what 
                constitutes excellence in practice and be 
                appropriate to the particular scope of care 
                involved;
                  (B) may vary in form for each of the covered 
                disciplines; and
                  (C) may exempt individual providers from 
                meeting certain standards based on their scope 
                of practice.
          (3) Recognition of individuals with extensive 
        practical experience.--For purposes of this section, 
        the Secretary shall, through regulation, provide a 
        method for the recognition of individuals whose 
        training or experience are determined to be equal to, 
        or in excess of, those of a graduate of an accredited 
        educational program in that specialty, or of an 
        individual who is regularly eligible to take the 
        licensure or certification examination for that 
        discipline.
    (d) Approved Bodies.--
          (1) In general.--Not later than the date described in 
        subsection (j)(2), the Secretary shall begin to certify 
        qualified entities as approved bodies with respect to 
        the accreditation of the various mechanisms by which an 
        individual can demonstrate compliance with the 
        standards promulgated under subsection (a), if such 
        organizations or agencies meet the standards 
        established by the Secretary under paragraph (2) and 
        provide the assurances required under paragraph (3).
          (2) Standards.--The Secretary shall establish minimum 
        standards for the certification of approved bodies 
        under paragraph (1) (including standards for 
        recordkeeping, the approval of curricula and 
        instructors, the charging of reasonable fees for 
        certification or for undertaking examinations, and 
        standards to minimize the possibility of conflicts of 
        interest), and other additional standards as the 
        Secretary may require.
          (3) Assurances.--To be certified as an approved body 
        under paragraph (1), an organization or agency shall 
        provide the Secretary satisfactory assurances that the 
        body will--
                  (A) be a nonprofit organization;
                  (B) comply with the standards described in 
                paragraph (2);
                  (C) notify the Secretary in a timely manner 
                if the body fails to comply with the standards 
                described in paragraph (2); and
                  (D) provide such other information as the 
                Secretary may require.
          (4) Withdrawal of approval.--
                  (A) In general.--The Secretary may withdraw 
                the certification of an approved body if the 
                Secretary determines the body does not meet the 
                standards under paragraph (2).
                  (B) Effect of withdrawal.--The withdrawal of 
                the certification of an approved body under 
                subparagraph (A) shall have not effect on the 
                certification status of any individual or 
                person that was certified by the approved body 
                prior to the date of such withdrawal.
    (e) Existing State Standards.--Standards established by a 
State for the licensure or certification of personnel, 
accreditation of educational programs, or administration of 
examinations shall be deemed to be in compliance with the 
standards of this section unless the Secretary determines that 
such State standards do not meet the minimum standards 
prescribed by the Secretary or are inconsistent with the 
purposes of this section. The Secretary shall establish a 
process by which a State may respond to or appeal a 
determination made by the Secretary under the preceding 
sentence.
    (f) Rule of Construction.--Nothing in this section shall be 
construed to prohibit a State or other approved body from 
requiring compliance with a higher standard of education and 
training than that specified by this section. Notwithstanding 
any other provision of this section, individuals who provide 
medical imaging services relating to mammograms shall continue 
to meet the standards applicable under the Mammography Quality 
Standards Act of 1992.
    (g) Evaluation and Report.--The Secretary shall 
periodically evaluate the performance of each approved body 
under subsection (d) at an interval determined appropriate by 
the Secretary. The results of such evaluations shall be 
included as part of the report submitted to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives in accordance with 354(e)(6)(B).
    (h) Delivery of and Payment for Services.--Not later than 
the date described in subsection (j)(3), the Secretary shall 
promulgate regulations to ensure that all programs under the 
authority of the Secretary that involve the performance of or 
payment for medical imaging or radiation therapy, are performed 
in accordance with the standards established under this 
section.
    (i) Alternative Standards for Rural and Underserved 
Areas.--
          (1) In general.--The Secretary shall determine 
        whether the standards established under subsection (a) 
        must be met in their entirety for medical imaging or 
        radiation therapy that is performed in a geographic 
        area that is determined by the Medicare Geographic 
        Classification Review Board to be a ``rural area'' or 
        that is designated as a health professional shortage 
        area. If the Secretary determines that alternative 
        standards for such rural areas or health professional 
        shortage areas are appropriate to assure access to 
        quality medical imaging, the Secretary is authorized to 
        develop such alternative standards.
          (2) State discretion.--The chief executive officer of 
        a State may submit to the Secretary a statement 
        declaring that an alternative standard developed under 
        paragraph (1) is inappropriate for application to such 
        State, and such alternative standard shall not apply in 
        such submitting State. The chief executive officer of a 
        State may rescind a statement described in this 
        paragraph following the provision of appropriate notice 
        to the Secretary.
    (j) Applicable Timelines.--
          (1) General implementation regulations.--Not later 
        than 18 months after the date of enactment of this 
        section, the Secretary shall promulgate such 
        regulations as may be necessary to implement all 
        standards in this section except those provided for in 
        subsection (d)(2).
          (2) Minumum standards for certification of approved 
        bodies.--Not later than 24 months after the date of 
        enactment of this section, the Secretary shall 
        establish the standards regarding approved bodies 
        referred to in subsection (d)(2) and begin certifying 
        approved bodies under such subsection.
          (3) Regulatons for delivery of or payment for 
        services.--Not later than 36 months after the date of 
        enactment of this section, the Secretary shall 
        promulgate the regulations described in subsection (h). 
        The Secretary may withhold the provision of Federal 
        assistance as provided for in subsection (h) beginning 
        on the date that is 48 months after the date of 
        enactment of this section.
    (k) Definitionis.--In this section:
          (1) Approved body.--The term ``approved body'' means 
        an entity that has been certified by the Secretary 
        under subsection (d)(1) to accredit the various 
        mechanisms by which an individual can demonstrate 
        compliance with the standards promulgated under 
        subsection (a) with respect to performing, planning, 
        evaluating, or verifying patient dose for medical 
        imaging or radiation therapy.
          (2) Medical imaging.--The term ``medical imaging'' 
        means any procedure used to visualize tissues, organs, 
        or physiologic processes in humans for the purpose of 
        diagnosing illness or following the progression of 
        disease. Images may be produced utilizing ionizing 
        radiation, radiopharmaceuticals, magnetic resonance, or 
        ultrasound and image production may include the use of 
        contrast media or computer processing. For purposes of 
        this section, such term does not include routine dental 
        diagnostic procedures.
          (3) Perform.--The term ``perform'', with respect to 
        medical imaging or radiation therapy, means--
                  (A) the act of directly exposing a patient to 
                radiation via ionizing or radio frequency 
                radiation, to ultrasound, or to a magnetic 
                field for purposes of medical imaging or for 
                purposes of radiation therapy; and
                  (B) the act of positioning a patient to 
                receive such an exposure.
          (4) Plan.--The term ``plan'', with respect to medical 
        imaging or radiation therapy, means the act of 
        preparing for the performance of such a procedure to a 
        patient by evaluating site-specific information, based 
        on measurement and verification of radiation dose 
        distribution, computer analysis, or direct measurement 
        of dose, in order to customize the procedure for the 
        patient.
          (5) Radiation therapy.--The term ``radiation 
        therapy'' means any procedure or article intended for 
        use in the cure, mitigation, treatment, or prevention 
        of disease in humans that achieves its intended purpose 
        through the emission of radiation.
    (l) Sunset.--This section shall have no force or effect 
after September 30, 2016.

                                  
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