Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service provided from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants.
Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) 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; and (4) approve and publish a list of accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to assure access to quality medical imaging.
Amends the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services furnished on or after January 1, 2013, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.
[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3652 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 3652
To amend the Public Health Service Act and title XVIII of the Social
Security Act to make the provision of technical services for medical
imaging examinations and radiation therapy treatments safer, more
accurate, and less costly.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 25, 2009
Mr. Barrow introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Public Health Service Act and title XVIII of the Social
Security Act to make the provision of technical services for medical
imaging examinations and radiation therapy treatments safer, more
accurate, and less costly.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Consistency, Accuracy,
Responsibility, and Excellence in Medical Imaging and Radiation Therapy
Act of 2009''.
SEC. 2. PURPOSE.
The purpose of this Act is to improve the quality and value of
health care by increasing the safety and accuracy of medical imaging
examinations and radiation therapy procedures, thereby reducing
duplication of services and decreasing costs.
SEC. 3. QUALITY OF MEDICAL IMAGING AND RADIATION THERAPY.
Part F of title III of the Public Health Service Act (42 U.S.C. 262
et seq.) is amended by adding at the end the following:
``Subpart 4--Medical Imaging and Radiation Therapy
``SEC. 355. QUALITY OF MEDICAL IMAGING AND RADIATION THERAPY.
``(a) Qualified Personnel.--
``(1) In general.--Effective January 1, 2013, personnel who
perform or plan the technical component of either medical
imaging examinations or radiation therapy procedures for
medical purposes must be qualified under this section to
perform or plan such services.
``(2) Qualification.--Individuals qualified to perform or
plan the technical component of medical imaging examinations or
radiation therapy procedures must--
``(A) possess current certification in each medical
imaging or radiation therapy modality and service
provided from a certification organization designated
by the Secretary pursuant to subsection (c); or
``(B) possess current State licensure, or
certification, where--
``(i) such services and modalities are
within the scope of practice as defined by the
State for such profession; and
``(ii) the requirements for licensure,
certification, or registration meet or exceed
the standards established by the Secretary
pursuant to this section.
``(3) State licensure, certification, or registration.--
``(A) Nothing in this section diminishes the
authority of a State to define requirements for
licensure, certification, or registration, the
requirements for practice, or the scope of practice of
personnel.
``(B) The Secretary shall not take any action under
this section that would require licensure by a State of
those who perform or plan the technical component of
medical imaging examinations or radiation therapy
procedures.
``(4) Exemptions.--The qualification standards described in
this subsection shall not apply to physicians (as defined in
section 1861(r) of the Social Security Act (42 U.S.C.
1395x(r))) or to nurse practitioners and physician assistants
(each as defined in section 1861(aa)(5) of the Social Security
Act (42 U.S.C. 1395x(aa)(5))).
``(b) Establishment of Standards.--
``(1) In general.--For the purposes of determining
compliance with subsection (a), the Secretary, in consultation
with recognized experts in the technical provision of medical
imaging or radiation therapy services, shall establish minimum
standards for personnel who perform, plan, evaluate, or verify
patient dose for medical imaging examinations or radiation
therapy procedures. Such standards shall not apply to the
equipment used.
``(2) Experts.--For the purposes of this subsection, the
Secretary shall select expert advisers 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) Minimum standards.--Minimum standards may vary in
form for each of the covered disciplines, reflecting the unique
or specialized nature of the technical services provided, and
shall represent expert consensus from those practicing in each
of the covered disciplines as to what constitutes excellence in
practice and be appropriate to the particular scope of care
involved.
``(4) Allowance for additional standards.--Nothing in this
subsection shall be construed to prohibit a State or
certification organization from requiring compliance with
higher standards than the minimum standards specified by the
Secretary pursuant to this subsection.
``(5) Timeline.--The Secretary shall promulgate regulations
for the purposes of carrying out this subsection no later than
18 months after the date on which this section is enacted.
``(c) Designation of Certification Organizations.--
``(1) In general.--The Secretary shall establish a program
for designating certification organizations that the Secretary
determines have established appropriate procedures and programs
for certifying personnel as qualified to furnish medical
imaging or radiation therapy services.
``(2) Factors.--When designating certification
organizations, and when reviewing or modifying the list of
designated organizations for the purposes of paragraph (4)(B),
the Secretary shall consider--
``(A) whether the certification organization has
established certification requirements for individuals
that are consistent with or exceed the minimum
standards established in subsection (b);
``(B) whether the certification organization has
established a process for the timely integration of new
medical imaging or radiation therapy services into the
organization's certification program;
``(C) whether the certification organization has
established education and continuing education
requirements for individuals certified by the
organization;
``(D) whether the organization has established
reasonable fees to be charged to those applying for
certification;
``(E) whether the examinations leading to
certification by the certification organization are
accredited by an appropriate accrediting body as
defined in subsection (d);
``(F) the ability of the certification organization
to review applications for certification in a timely
manner; and
``(G) such other factors as the Secretary
determines appropriate.
``(3) Equivalent education, training, and experience.--
``(A) In general.--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. Such authority
shall expire seven years after the enactment of this
section.
``(B) Eligibility.--The Secretary shall not
recognize any individual pursuant to the authority of
subparagraph (A) unless such individual--
``(i) was performing or planning the
technical component of medical imaging
examinations or radiation therapy treatments
prior to enactment of this section; and
``(ii) is ineligible to take the licensure
or certification examination for that
discipline.
``(4) Process.--
``(A) Regulations.--The Secretary shall, by July 1,
2012, promulgate regulations for designating
certification organizations pursuant to this paragraph.
``(B) Designations and list.--The Secretary shall,
by January 1, 2013, make determinations regarding all
certification organizations that have applied for
designation pursuant to the regulations promulgated
under subparagraph (A), and shall publish a list of all
certification organizations that have received
designation.
``(C) Periodic review and revision.--The Secretary
shall periodically review the list, taking into account
the factors established under paragraph (2). After such
review, the Secretary may, by regulation, modify the
list of certification organizations that have received
designation.
``(D) Certifications prior to removal from list.--
If the Secretary removes a certification organization
from the list of certification organizations designated
under subparagraph (B), any individual who was
certified by the certification organization during or
before the period beginning on the date on which the
certification organization was designated as a
certification organization under subparagraph (B) and
ending on the date on which the certification
organization is removed from such list shall be
considered to have been certified by a certification
organization designated by the Secretary under
subparagraph (B) for the remaining period that such
certification is in effect.
``(d) Approved Accrediting Bodies.--
``(1) In general.--The Secretary shall publish a list of
entities that are approved accrediting bodies for certification
organizations for purposes of subsection (c)(2)(E). The
Secretary shall publish the list no later than 24 months after
enactment of this section and shall revise the list as
appropriate.
``(2) Requirements for approval.--The Secretary shall not
approve an accrediting body for certification organizations
unless the Secretary determines that such accrediting body--
``(A) is a nonprofit organization;
``(B) is a national or international organization
with accreditation programs for examinations leading to
certification by certification organizations;
``(C) has established standards for recordkeeping
and to minimize the possibility of conflicts of
interest; and
``(D) demonstrates compliance with any other
requirements established by the Secretary.
``(3) Withdrawal of approval.--The Secretary may withdraw
the approval of an accrediting body if the Secretary determines
that the body does not meet the standards defined in paragraph
(2).
``(e) 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 examinations or radiation
therapy procedures that are performed and planned 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 examinations or
radiation therapy procedures, 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.
``(f) Rule of Construction.--Notwithstanding any other provision of
this section, individuals who provide medical imaging examinations
relating to mammograms shall continue to meet the regulations
applicable under the Mammography Quality Standards Act of 1992, as
amended.
``(g) Definitions.--As used in this section--
``(1) Medical imaging.--The term `medical imaging' means
any examination or procedure used to visualize tissues, organs,
or physiologic processes in humans for the purpose of
detecting, diagnosing, treating or impacting the progression of
disease or illness. For purposes of this section, such term
does not include routine dental diagnostic procedures or
advanced imaging procedures as defined in section 1834(e)(1)(B)
of the Social Security Act.
``(2) Perform.--The term `perform', with respect to medical
imaging or radiation therapy, means--
``(A) the act of directly exposing a patient to
radiation including 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.
``(3) 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.
``(4) 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 ionizing
or non-ionizing radiation.''.
SEC. 4. PAYMENT AND STANDARDS FOR MEDICAL IMAGING AND RADIATION
THERAPY.
Section 1848(b)(4) of the Social Security Act (42 U.S.C. 1395w-
4(b)(4)) is amended--
(1) in subparagraph (A), by striking the ``imaging'' and
inserting ``medical imaging and radiation therapy'' and;
(2) by adding at the end the following new subparagraph:
``(C) Payment for medical imaging and radiation
therapy services.--With respect to expenses incurred
for the planning and performing of the technical
component of medical imaging examinations or radiation
therapy procedures furnished on or after January 1,
2013, payment shall be made under this section only if
the examination or procedure is planned or performed by
an individual who meets the requirements established by
the Secretary under section 355 of the Public Health
Service Act.''.
SEC. 5. REPORT ON THE EFFECTS OF THIS ACT.
(a) In General.--The Secretary of Health and Human Services, acting
through the Director of the Agency for Healthcare Research and Quality,
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate, the Committee on Finance of the Senate, and the
Committee on Energy and Commerce of the House of Representatives, a
report on the effects of this Act no later than 5 years after the date
of the enactment of this Act.
(b) Requirements.--Such report shall include the types and numbers
of individuals qualified to perform or plan the technical component of
medical imaging or radiation therapy services for whom standards have
been developed, the impact of such standards on diagnostic accuracy and
patient safety, and the availability and cost of services. Entities
reimbursed for technical services through programs operating under the
authority of the Secretary of Health and Human Services shall be
required to contribute data to such report.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to House Energy and Commerce
Referred to House Ways and Means
Referred to the Subcommittee on Health.
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