I 111th CONGRESS 1st Session H. R. 3652 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.

1.

Short title

This Act may be cited as the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009.

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.

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: 4

Medical Imaging and Radiation Therapy

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.

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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. .

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.