Alliance Draft of CARE HHS Regulations

The Alliance for Quality Medical Imaging and Radiation Therapy has been working to develop revised regulations that will be submitted to the Department of Health & Human Services (HHS) after the CARE bill is enacted.  The current regulations (42 CFR, Part 75) were published by HHS in 1985 after the Consumer-Patient Radiation Health & Safety Act was passed by Congress in 1981.  The 1985 regulations address only radiography, dental radiography, radiation therapy and nuclear medicine and do not reflect many of the current practice standards of medical imaging and radiation therapy disciplines.  The document below is a consensus draft of the Alliance’s proposed changes to the current HHS regulations. It is a “working” document and is not finalized. Some of the most common questions about the draft HHS regulations are answered below. For more information call the ASRT Government Relations department at 800-444-2778, Ext. 1308 or email governmentrelations@asrt.org.

Why don’t we write standards into the bill/law?

Writing education and credentialing standards into the CARE bills and ultimately into the 1981 CPRHSA would require us to start from scratch. The CARE bills build on the existing law and enhance it. Writing standards into law would require a complete rewrite of the 1981 CPRHSA. It is politically more feasible to just amend the portion of the CPRHSA regarding enforcement and to keep the regulations specifying the education and credentialing standards under the authority of HHS. HHS is more knowledgeable about the specific credentialing guidelines for medical professionals than the 535 voting members of Congress.

If we don’t write the standards in to the bill/law, how will we get what we want?

As evidenced by the 1981 CPRHSA, many times political bargains are struck and we don’t always get the “perfect” outcome. However by developing strategic alliances, developing materials in advance rather than leaving them to someone else to write, and engaging professional representation on Capitol Hill and for our work with HHS we’re prepared to get as close to “perfect” as we can.  Even by writing the standards into the bill/law it’s uncertain as to what will come out of Congress or even if the bill will be passed into law, but with the standards written into the bill they will most likely not be what we want.

How can we ensure that HHS will write “good” standards?

Once the CARE Bill is passed, HHS is required by the Federal Administrative Procedures Act to publish in the Federal Register a notice called a “Notice of Proposed Rulemaking (NPRM).” This is an opportunity for the public to comment on what they think should be included in the education and credentialing standards. ASRT, along with the Alliance for Quality Medical Imaging & Radiation Therapy, has been working on a comprehensive draft of updated education and credentialing guidelines to provide to HHS when the rulemaking process begins. This document will most likely be the document upon which HHS will base their education and credentialing standards. Other organizations may also make comments, but the majority of organizations who would normally make public comments on proposed education and credentialing regulations have already been working on the Alliance draft.

If we get “good” standards, how can we make sure they won’t arbitrarily be changed by HHS in the future?

HHS must follow the Administrative Procedures Act before any regulatory changes can be made. This means that ASRT and the Alliance will have the opportunity during the public comment period to bring any “bad” standards or inconsistencies to HHS’ attention before they are finalized. Also, if HHS does not publish good standards and the radiologic sciences community feels strongly about it, there are legal remedies that can be pursued.

Why are we updating the 1985 HHS educational and credentialing standards?

In the 20 years since these standards were published there have been vast changes in the radiologic sciences. New technologies and professions such as MRI and medical dosimetry have emerged. Medical physics is playing a larger role in patient care and radiologic technologists’ duties have changed substantially. New educational accreditation methods need to be recognized along with expanded competencies, credentialing requirements and credentialing organizations. Ideally, we should look at the federal educational and credentialing standards every five years and ensure they are still applicable to the profession and the practice environment.

I noticed that there are standards for “limited x-ray machine operators” included in the draft. LXMOs are not licensed in my state. Will my state have to start licensing LXMOs?

No. ASRT does not support the expansion of LXMO licensure in states that do not currently permit LXMOs to perform limited radiography, and the CARE bill does not require states that currently do not license LXMOs using inconsistent standards. The CARE bill will require states that license LXMOs to adopt the education and competency assessment standards for limited radiography personnel that are specified in the draft regulations.

Who are the members of The Alliance for Quality Medical Imaging and Radiation Therapy?

As of June 28, 2006 the members are as follows:

Founding Members:

American Society of Radiologic Technologists

Society of Nuclear Medicine-Technologist Section

Alliance Members:

American Association of Medical Assistants

American Association of Medical Dosimetrists

American Association of Physicists in Medicine

American College of Medical Physics

American Registry of Radiologic Technologists

Association of Educators in Radiologic Sciences

Association of Vascular and Interventional Radiographers

Cardiovascular Credentialing International

Joint Review Committee on Education in Cardiovascular Technology

Joint Review Committee on Education in Nuclear Medicine Technology

Joint Review Committee on Education in Radiologic Technology

Nuclear Medicine Technology Certification Board

Section for Magnetic Resonance Technologists of International Society of Magnetic

Resonance in Medicine

Society for Radiation Oncology Administrators

Society of Diagnostic Medical Sonography

Society of Invasive Cardiovascular Professionals

Consulting Organizations:

American College of Radiology

American Society for Therapeutic Radiation and Oncology

Conference of Radiation Control Program Directors

Other Supporters

American Cancer Society

American Heart Association Council on Cardiovascular Radiology

American Organization of Nurse Executives

American Osteopathic College of Radiology

Cancer Research Foundation of America

Help Disabled War Veterans/Help Hospitalized Veterans

International Society of Radiographers and Radiological Technologists

National Coalition of Cancer Survivorship

Medical Imaging Consultants, Inc.

Philips Medical Systems, Inc.

AAMA