Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2011 - 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, 2014: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform 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 from the requirements of this Act.
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 process for the certification 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; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging.
Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2104 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 2104
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
June 2, 2011
Mr. Whitfield (for himself, Mr. Barrow, Mr. Boswell, Mr. Cohen, Mr.
Connolly of Virginia, Mr. Duncan of Tennessee, Mr. Guthrie, Mr. Hall,
Mr. Harper, Ms. Eddie Bernice Johnson of Texas, Mr. Jones, Mr. Kildee,
Mr. Kind, Mr. Lance, Mr. Heinrich, Mr. McIntyre, Mrs. Myrick, Ms.
Richardson, and Mr. Rush) 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 2011''.
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, 2014, personnel who
perform or plan the technical component of either medical
imaging examinations or radiation therapy procedures for
medical purposes shall be qualified under this section to
perform or plan such services.
``(2) Qualifications.--Individuals qualified to perform or
plan the technical component of medical imaging examinations or
radiation therapy procedures shall--
``(A) possess current certification in the medical
imaging or radiation therapy modality or service they
plan or perform 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) In general.--Nothing in this section shall be
construed to diminish 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) Limitation.--The Secretary shall not take any
action under this section that would require licensure
by a State of personnel who perform or plan the
technical component of medical imaging examinations or
radiation therapy procedures.
``(4) Exemptions.--The qualification standards described in
this subsection and the payment provisions in section
1848(b)(4)(C) of the Social Security Act 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))). Such practitioners shall not be included under
the terms `personnel' or `qualified personnel' for purposes of
this section.
``(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) Recognized experts.--
``(A) In general.--For the purposes of this
subsection, the Secretary shall select recognized
expert advisers to reflect a broad and balanced input
from all sectors of the health care community that are
involved in the provision of services of the type
described in paragraph (1) to avoid undue influence
from any single sector of practice relating to the
content of such standards.
``(B) Definition.--In this paragraph, the term
`recognized experts' includes--
``(i) representatives of all medical
specialties and providers that perform or plan
medical imaging procedures;
``(ii) representatives of all medical
specialties and providers that perform or plan
radiation therapy procedures;
``(iii) medical imaging and radiation
therapy technology experts; and
``(iv) other experts determined appropriate
by the Secretary.
``(3) Minimum standards.--Minimum standards established
under this subsection shall reflect the unique or specialized
nature of the technical services provided, and shall represent
expert consensus from those practicing in each of the covered
imaging modalities and radiation therapy procedures 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
standards that exceed the minimum standards specified by the
Secretary pursuant to this subsection.
``(5) Timeline.--Not later than 12 months after the date of
enactment of this section, the Secretary shall promulgate
regulations for the purposes of carrying out this subsection.
``(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 under this subsection, 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
process for 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 to demonstrate their experience meets
the educational standards for qualified personnel in
their imaging modality or radiation therapy procedures.
Such process may include documentation of items such
as--
``(i) years and type of experience;
``(ii) a list of settings where experience
was obtained; and
``(iii) verification of experience by
supervising physicians or clinically qualified
hospital personnel.
``(B) Eligibility.--The Secretary shall not
recognize any individual as having met the educational
standards applicable under this paragraph based on
experience pursuant to the authority of subparagraph
(A) unless such individual was performing or planning
the technical component of medical imaging examinations
or radiation therapy treatments prior to the date of
enactment of this section.
``(C) Certification test requirement.--To be
eligible to be certified under this subsection an
individual shall, not later than 18 months after the
date on which the list of designated certification
organizations is published under paragraph (4),
successfully complete a certification examination
administered by a designated certification
organization. During such 18-month period, the
penalties provided for under section 1848(b)(4)(C) of
the Social Security Act (as added by section 4 of the
Consistency, Accuracy, Responsibility, and Excellence
in Medical Imaging and Radiation Therapy Act of 2011)
shall not apply to such individuals.
``(4) Process.--
``(A) Regulations.--Not later than July 1, 2013,
the Secretary shall promulgate regulations for
designating certification organizations pursuant to
this subsection.
``(B) Designations and list.--Not later than
January 1, 2014, the Secretary shall 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 a
designation.
``(C) Periodic review and revision.--The Secretary
shall periodically review the list under subparagraph
(B), 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 such 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 such subparagraph, 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 such
subparagraph for the remaining period that such
certification is in effect.
``(d) Approved Accrediting Bodies.--
``(1) In general.--Not later than 24 months after the date
of enactment of this section, 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 revise such list as appropriate.
``(2) Requirements for approval.--The Secretary shall not
approve an accrediting body for certification organizations
under this subsection 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 under this paragraph if the
Secretary determines that the body does not meet the
requirements of 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
ensure 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) Definition.--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 or ophthalmologic diagnostic
procedures or ultrasound guidance of vascular access
procedures.
``(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 on 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. REQUIRED 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 by adding at the end the following new
subparagraph:
``(E) Required standards 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 (as defined in subsection
(g) of section 355 of the Public Health Service Act)
furnished on or after January 1, 2014, 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 such section 355.''.
SEC. 5. REPORT ON THE EFFECTS OF THIS ACT.
(a) In General.--Not later than 5 years after the date of the
enactment of this Act, 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.
(b) Requirements.--The report under subsection (a) 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 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 the Subcommittee on Health.
Referred to the Subcommittee on Health.
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