[Congressional Record Volume 152, Number 21 (Friday, February 17, 2006)]
[Senate]
[Pages S1462-S1464]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ENZI (for himself and Mr. Kennedy):
  S. 2322. A bill 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; to 
the Committee on Health, Education, Labor, and Pensions.
  Mr. ENZI. Mr. President, I rise to introduce the Consumer Assurance 
of Radiologic Excellence Act of 2006. This bill would improve the 
quality and value of diagnostic medicine. If the RadCARE Act is 
enacted, 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.
  Most of us feel anxious when we see the doctor, regardless of whether 
the evaluation reveals a problem. That is particularly true when we are 
concerned about cancer. How reassuring it is for us to believe that our 
physicians have available to them the full range of diagnostic tests 
and therapeutic procedures necessary to manage our care in the best way 
possible. We expect, too, that everyone who participates in our care is 
highly qualified to perform the services they provide. It is an 
expectation that each of us deserves to have but, all too often, is 
unrealistic.
  Effective treatments are predicated on accurate diagnoses, and every 
treatment has the potential to cause harm. Missed, inaccurate, or 
delayed diagnoses can lead to unnecessary or dangerous therapies, with 
avoidable medical costs the least of the consequences. Physicians and 
patients should be able to trust that the technical providers such as 
the radiologic technologists, ultrasonography technologists, and 
medical radiation technologists who actually perform these tests are 
well qualified to do their jobs and have the appropriate credentials 
help to provide this assurance.
  Cancer of many different types has become much more common; indeed, 
cancer is the second leading cause of death in America, behind only 
heart disease. 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 our 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 health care 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 
a rapid increase in the 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 health care. These costs are not limited to charges alone. 
Sedation, administered to facilitate a diagnostic imaging study, may 
compromise breathing or heart function. Therapeutic interventions 
based, in part, on these studies are fraught with potential 
complications, and the risk increases if the diagnostic information is 
incomplete or inaccurate. Similarly, a decision not to intervene 
carries its own risks, especially if the facts on which the decision is 
made are in error.
  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 your tumor. One doesn't have to be a doctor to recognize 
that this is not good medicine to rely solely on the good intentions of 
those who employ these providers.
  In its report to Congress this March, 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 RadCARE 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.

[[Page S1463]]

  Many will benefit if we pass the RadCARE Act. Better diagnostic 
images will help physicians to make faster, more accurate diagnoses or, 
alternatively, to exclude problems from further consideration. Risks 
such as sedation-related complications and radiation exposure will 
decrease. Patients will receive therapies that are more considered, 
precise, and safe. Provider and consumer confidence in the health care 
process will rise. Qualified technologists will be recognized for their 
professional achievements and motivated to improve their practice. 
Taxpayers, even if they are fortunate enough not to require diagnostic 
or therapeutic radiologic services, will appreciate that their tax 
dollars are not being wasted on poor quality, repetitive diagnostic 
examinations or unsafe therapies.

  Could the RadCARE Act have unintended, adverse consequences? Some 
argue that meaningful credentialing of these technical providers will 
decrease access to care--that it is better to have non-credentialed 
providers than none at all. Certainly, establishing and maintaining a 
health care workforce that is adequate in size is an important goal for 
us to achieve. I would make the case, though, for quality--that bad 
information is worse than no information at all. It is reassuring to 
note that, in those States that do regulate this type of technical 
practice, the number of practitioners has remained stable. To further 
address this concern, the RadCARE Act gives the Secretary of Health and 
Human Services the flexibility necessary to modify regulations 
promulgated under this legislation, so that access to services is not 
compromised but standards are preserved.
  Some fear that credentialing technical providers will increase health 
care expenses by inflating personnel costs. Again, in those 
jurisdictions that regulate this type of technical practice, wage 
inflation has not occurred. Regardless, while I believe that workers 
should be compensated, fairly and proportionately, for the work that 
they do, the cost savings from delivering care correctly far outweigh 
any potential cost increase that might result from higher salaries.
  Others are concerned that the RadCARE Act could infringe on the 
States' right to regulate health care practice or that Congress lacks 
the capacity to define the standards of practice that should apply. The 
Act does not codify any particular State action; rather, it provides a 
substantial economic incentive to the States to establish, at least, 
minimum standards, an action for which there is precedent in the 
Mammography Quality Standards Act and one that is consistent with 
current public and private sector initiatives, such as ``pay for 
performance,'' that tie reimbursement to recognized best practices. 
Similarly, the RadCARE Act does not specify what standards should be 
followed but gives the Secretary the opportunity to derive those 
standards from those most qualified to provide them: the professional 
community. Indeed, the Act is supported by the Alliance for Quality 
Medical Imaging and Radiation Therapy, a consortium of over 275,000 
technical professionals.
  I invite my colleagues to join me and Senator Kennedy as sponsors of 
this bill to increase the quality and value of these important 
diagnostic procedures and lessen the possibility of life-threatening 
medical mistakes.
  I ask that the text of the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2322

       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 ``Consumer Assurance of 
     Radiologic Excellence Act of 2006''.

     SEC. 2. PURPOSE.

       The purpose of this Act is to improve the quality and value 
     of healthcare by increasing the safety and accuracy of 
     medical imaging examinations and radiation therapy 
     treatments, 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) 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 no effect on the certification status of any 
     individual or person that was certified by that 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.

[[Page S1464]]

       ``(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.
       ``(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.--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.
       ``(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) Minimum 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) Regulations 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) Definitions.--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.''.

     SEC. 4. REPORT ON THE EFFECTS OF THIS ACT.

       (a) Not later than 5 years after the date of 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 and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report on the effects of this Act. Such 
     report shall include the types and numbers of providers 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.
                                 ______