59–010 

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. 


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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 


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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 minVerDate Aug 31 2005 19:02 Dec 11, 2006 Jkt 059010 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\SR363.XXX SR363

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imum 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 


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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 addi- tional 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 


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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 


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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. 


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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): 


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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 


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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.—


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(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 


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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 sitespecific 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, 


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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. 

Æ 


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