Relates to creating the profession of orthotics, prosthetic and pedorthic practice

Justification

For a number of significant reasons, there is a growing and perhaps even desparate need for professionalized orthotic and prosthetic (O&P) care in New York and the United States. Since 1973, the U.S. Department of Education has identified O&P training as a national priority with both a training and practitioner deficit. Several factors now combine to exascerbate that stated need exponentionally.

Some of these factors are health related. The Department of Health and Human Services recently reported on the twin epidemics of diabetes. and obesity. Diabetes is the leading cause of limb loss, and the recent explosion in cases of obesity and diabetes are expected to result in the escalation of diabetic amputations. The number of Americans with diagnosed diabetes is, projected to increase 165 percent by 2050. Cardiovascular disease, the nation's leading killer, is the second leading cause of amputations. Millions of Americans living today with cardiovascular disease are at an increased risk for amputation. Obesity further complicates the risk of Americans developing a chronic disease like heart disease or diabetes and increases the risk of amputations to those living with these conditions.

The National Health Interview Survey indicates that 35 million Americans (one in eight) have disabling conditions that interfere with life activities and 16 percent of those individuals reported an orthopedic impairment. In 1990, more than 3;5 million persons in the U.S. were using some kind of orthosis, more than a 100 percent increase since 1980. Approximately 20.3 percent of the 2 million Americans with complete or partial paralysis of extremities use orthoses (Nielsen, May 2002).

The demand for provider services is expected to increase by 25 percent for orthotic care and 47 percent for prosthetic care by 2020. This practitioner shortage means more demand than ever for graduates of the nation's O&P education programs. Without an increase in the number of O&P students, by the year 2020, only 61 percent or less of the population using orthoses will be served. Similarly, only 66 percent or less of prosthetic consumers' needs will be met by 2020-a population expected to increase by 47 percent by that year.

In addition to these medical causes, our nation's military contributes to the need for this legislation. Since the war on terror began in 2001, more than 14,000 troops have been wounded in Iraq and Afghanistan. Of those, nearly half still require long-term care. The most severely injured soldiers suffer from double and triple amputations, severe head and body trauma, blindness, deafness, and partial and full paralysis. The use of improvised explosive devices in Iraq has resulted in many cases of severe bums. To meet the growing need for the care and rehabilitation of the men and women who have sacrificed so much, the professionalization of O&P care is essential.

Furthermore, this legislation, by providing an enhanced level of professional care and education, will protect consumers of orthotic-prosthetic-pedorthic treatment in New York State against inadequate or substandard pratitioners. Our consumers are presently exposed to actual and potential harm in the following ways:

1. PHYSICAL HARM; Orthoses, prostheses and pedorthic devices fit intimately on the human body. Improper fit due to inadequate education and training of the practitioner cart result in the device, rather than improving the patient's life, actually complicating it and increasing the risk of physical injury to the patient. A well designed and carefully fitted orthosis or prosthesis can significantly improve a physically challenged individual's life, allowing him or her to be a productive member of our State to the fullest of his or her potential. However, a poorly designed and/ or poorly fitted one can cause further medical complications and/or result in serious physical injury to the patient.

2. PSYCHOLOGICAL HARM; The physically challenged individual or his loved ones, when presented with an inadequate device or incompetent service, can and do experience emotional harm. Decreased self-confidence, diminished self-worth, distress from chronic discomfort, and increased self-consciousness are but a few of the problems which cumulatively add to the grief already experienced due to the sense of loss or diminished body image.

3. FINANCIAL HARM; Because orthotics, prosthetic and pedorthic practice is unregulated, consumers, their loved ones and the taxpayers of this state suffer from numerous economic hardships.

The proposed legislation is the most effective means of addressing these harms. It will insure the public of the initial and continuing professional ability of orthotic-prosthetic-pedorthic practitioners by mandating their competency to provide custom-made orthoses, prostheses and pedorthic devices. Licensure will also insure that the public has a mechanism for lodging complaints to a disciplining authority when they are subjected to unprofessional conduct.

Licensure is also warranted by the recognition by other medical professionals of the emergence of the field of orthotics-prosthetics-pedorthics as a separate and distinct health care profession. The American Medical Association recognizes the field of orthotics-prosthetics and Pedorthics as distinct specialties. It has a unique and expanding body of knowledge, its own research and training facilities and institutions, and the expertise of its practitioners and educators is increasingly relied upon by the rest of the medical Community.

Moreover the increasing technological sophistication of the field makes mandated levels of training and education essential in assuring competent care by practitioners. Medicare, recognizing the special expertise of the prosthetist, requiring a prosthetist's evaluation of the functional potential and appropriate components for new amputees. This program's view that the referring physician is not the sole repository of information for identifying a patient's functional potential - is common. As a result, collaboration between prosthetist and physician is also a common practice in the development of the correct prescription for a patient.

Although there are a number of federal laws regulating prosthetic, orthotic and pedorthic devices, none protect the consumer from incompetent or unscrupulous practitioners. Under Title 21, Chapter 9 of the Code of Federal Regulations, the Federal Food, Drug, and Cosmetic Act addresses prosthetic and orthotic devices within the provisions of Subchapter V (Drugs and Devices). As a result of this statutory frame work, the consumer is left to seek redress for any wrongs committed by an unscrupulous or incompetent practitioner in the courts.

The need to provide the public with a means of identifying qualified practitioners is more compelling today than ever before. This critical need continues to grow dramatically with each passing year, as the field grows ever more sophisticated and broadly utilized, resulting in ever greater public exposure to the potential for serious physical, emotional, and financial harm.

Prior legislative history

New bill.

Fiscal implications

None to the State or local governments.

Effective date

January 1st next succeeding the date on which it shall have become a law.