April 2007 | Vol. 25, No. 4

CARE Bill Update

BACKGROUND:

The educational and credentialing regulations currently in place for medical imaging (42 CFR, Part 75) were published by the Public Health Service / Department of Health and Human Services in 1985, following Congressional passage of the Consumer-Patient Radiation Health and Safety Act in 1981 (42 USC 10004). The regulations address only radiography, dental radiography, radiation therapy, and nuclear medicine technologists, all of whom use ionizing radiation in their work.

In March 2003, Rep. Heather Wilson of New Mexico introduced the Consumer Assurance of Radiologic Excellence (or “RadCARE”) bill. Three months later a similar bill was introduced in the Senate by Senators Enzi, Kennedy, Daschle, Lautenberg, and Dorgan. These bills imposed new requirements on the covered professions, most notably a provision that:

“Requires individuals prior to performing or preparing such imaging or therapy to have successfully completed a national exam approved by the Secretary.”

Both versions of the legislation, however, did provide for “excluding medical ultrasound procedures” making the legislation largely irrelevant to the Vascular (or other) Sonographer. Both bills languished in the relevant House and Senate Committees and were not passed.

In March 2005, the RadCare bill was re-introduced in the House with similar intent, and included language that excludes sonographers from the bills provisions:

“The State requires an individual who administers or plans medical imaging procedures or radiation therapy procedures to obtain a medical radiation license from the State, unless— the individual exclusively performs medical ultrasound or echocardiography.”

The exclusion language continued to make the legislation not directly applicable to SVU members.

CURRENT STATUS:

In February 2006, a different version of the CARE bill, S.2322, was introduced in the Senate, including in the “definitions” section:

“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.”

The inclusion of ultrasound in the bill’s provisions made it extremely relevant to SVU, SDMS, ASE, AIUM, and others representing the ultrasound community. S 2322 was passed unanimously in the Senate on December 6, 2006, but the House was not able to act on the legislation before the end of 109th Congress.

In the current 110th Congress, the CARE bill version passed in the Senate in 2006 was re-introduced in the House as H.R. 583. That legislation, which is now called the “Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act,” was introduced on January 17, 2007, and is currently being considered by the House Energy and Commerce Committee. The renaming of the bill signals the more inclusive nature of this legislation for other imaging specialties.

A companion bill to H.R. 583 is likely to be introduced in the Senate within the next couple of weeks. The bills are expected to gain bipartisan support, but the legislative calendar is likely to determine whether the bill is ultimately passed.

Current CARE Bill Highlights (From the Library of Congress)

• Imposes standards on personnel who perform, plan, or evaluate, or verify patient doses for, medical imaging studies and radiation therapy procedures and not on the equipment used. Exempts physicians, nurse practitioners, and physician assistants.
• Directs the Secretary to ensure that individuals demonstrate compliance with such standards.
• Requires the Secretary to provide a method for the recognition of individuals whose training and experience are determined to equal or exceed that of: (1) a graduate of an accredited educational program in that specialty; or (2) an individual who is regularly eligible to take the licensure or certification examination for that discipline.
• Directs the Secretary to certify qualified nonprofit organizations as approved bodies to provide accreditation to individuals that demonstrate compliance with such standards.
• Deems state standards for licensure or certification of personnel, accreditation of educational programs, or administration of examinations to be in compliance with the standards under this Act unless the Secretary determines otherwise. Requires the Secretary to establish a process by which a state may appeal such a determination.
• Requires the Secretary to ensure that all programs under the authority of the Secretary meet such standards.
• Authorizes the Secretary to develop alternative standards for rural areas or health professional shortage areas as appropriate to assure access to quality medical imaging.

The listed purpose of these bills is: “to make the provision of technical services for medical imaging examinations and radiation therapy treatments safer, more accurate, and less costly,” goals shared among all imaging societies and professionals. The House Bill has 37 co-sponsors, evenly split between Democrats and Republicans, although that number will likely increase dramatically over the coming weeks following an aggressive lobbying campaign by the bill’s supporters. The SVU Advocacy Committee and Sidley Austin, our legislative and regulatory advocacy counsel, are keeping close watch on the progress of this bill, given its potential national ramifications for credentialing standards in ultrasound.

Dave Parlato, BA RVT
SVU Advocacy Committee Chair

Links to the Current Versions of the Actual Bills:

HR 583 pdf: (110th) Jan 2007
http://frwebgate.access.gpo.gov/cgi-
bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h583ih.txt.pdf

S2322 pdf (109th) Dec 2006
http://frwebgate.access.gpo.gov/cgi-
bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2322rfh.txt.pdf