What One State Proposed as a Regulation System for Alternative Medicine


The Board of Medical Quality Assurance assembled experts from many disciplines to create this report proposing change in the medical practices act to include alternative therapies. We discovered this report in 1982. We consider it to be a great educational tool for legal and professional issues of alternative medicine. It is a great document for those seeking solutions to the dilemma of regulation in alternative medicine. It is also a great document for those seeking their health freedoms.

Draft legislation with actual language is included for a registration system with full and fair disclosure features. The proposed legislation failed in legislative committee in 1983. Nonetheless it represents a serious study of the issues involved in the regulation of alternative medicine.

Introduction

The PARG Study

I. BACKGROUND

A. Introduction: The Medical Practice Act

B. Some Contemporary Problems

C. The Basis for Licensure: Some Basic Assumptions

D. Goals of Licensure

E. The Current System of Regulation of Health Occupations

1. The Public System

2. The Private System: Private Controls on Health Care Delivery

F. Alternative Practitioners

G. The Issue of Freedom of Choice

H. Freedom of Choice and Informed Consent

II. A PROPOSAL TO REVISE THE MEDICAL PRACTICE ACT

A. Summary of Proposal

B. Discussion of Proposal

III IMPACT OF PROPOSAL

A. On Physicians

B. On Other Licensed Health Professions~and Occupations

C. On Unlicensed Orthodox Occupations

D. On Unlicensed "Unorthodox" Occupations

E. On Patients

F. On Health Facilities

IV. QUESTIONS AND ANSWERS ABOUT THE PROPOSAL

V. APPENDICES

1. Participants in the PARG Study Colloquia (not available)

2. Categories of Regulation

3. A List of Alternative Health Practices (not available)

4. Draft Legislation: Actual Language

(Draft registration for a full and fair disclosure system)

5. Estimate of the Number of Potential Registered Practitioners (not available)

***********************************************************************

Memorandum

Date: November, 1982

From: Board of Medical Quality Assurance

Subject: COVER MEMO

The following report is the result of over two years of study by the Board of Medical Quality Assurance of the impact of the current language of Section 2052 of the Business and Professions Code. This section defines the practice of medicine, giving physicians exclusive right to practice all forms of diagnosis and treatment of all physical and mental conditions. Although the section exempts other licensed health professions from this exclusive control of health care in limited ways, it is unlawful for an unlicensed person to offer or provide health care of any sort.

Because section 2052 is so all-encompassing, other health occupations must seek legislative exemptions to add to their scopes of practice. As health care science and technology expand, and as lower-level occupations assume more and more complex tasks, there has been an increasing awareness by many that the existing system of regulation is inflexible and cumbersome. in addition, there is a growing movement among consumers to seek alternative types and sources of care which generally are not available from physicians and other licensed professions and occupations.

As it concluded its study of the impact of Section 2052, the Board decided in June, 1982 to explore three possible changes in the law. These are to rewrite 2052, to design a program to register currently unlicensed health workers, and to mandate stronger penalties for violations of the revised definition of medicine. This paper will review the background of this decision, provide the Board with a detailed development of its proposal and analyze the proposal's impact. 

If the Board accepts the changes proposed in this report, it will be necessary to seek legislation to make them reality. It should be noted that since the Board met in Tune, 1982, and directed its staff to prepare this paper, a significant change has been made to the Board's proposal. The original proposal was to rewrite Section 2052 to include only four activities which were restricted to physicians: prescribing, surgery, radiation and invasive instrumentation. After careful study, the staff have concluded that it is critical to include the diagnosis of disease or other pathology in the group of activities restricted to physicians. The reasons for this conclusion, are that the potential for serious patient harm resulting from incorrect diagnosis, or failure to properly diagnose serious conditions, is so great that there is a clear need to provide state sanctions against those who diagnose without proper training and knowledge.

The effect of the following proposal, then, is to permit anyone to treat patients for any condition except for the performance of those activities which are restricted to physicians, and to require persons who are not eligible for some sort of licensure under other provision of law to register with the state before undertaking treatment. In order to register, such a person would be required to fully disclose any training or experience he or she has and in what sorts of activities they propose to be involved. Registrants also would be required . to give each patient a full disclosure of this same information, to advise the patient that the state does not endorse his or her competence or the effectiveness of the treatments offered, and to gain the patient's written agreement to treatment.

It should be remembered that the Board has not endorsed the approach outlined in these pages. The report was prepared at the direction of the Board in order to understand as completely as possible the implications of the proposal under discussion. Comments or suggestions from interested groups or individuals should be directed to Linda McCready, Board of Medical Quality Assurance, 1430 Howe Avenue, Sacramento, CA. 95825.

INTRODUCTION

The purpose of this report is to examine a number of issues relating to the ways that health professions and occupations are regulated in California. The report will summarize the development and current status of occupational regulation, propose changes to existing law, and analyze the impact of the changes if they are enacted. This report was prepared at the request of the Board of Medical Quality Assurance, following approximately three years of study and discussion.

THE PARG STUDY: PUBLIC REGULATION OF HEALTH CARE OCCUPATIONS IN CALIFORNIA 

As early as 1978, members of the BMQA were beginning to discuss the effects of Section 2052 on the provision of health care services in California. By 1979, the Board had agreed on the desirability of conducting a study to inquire into some of the issues described in this paper. After nearly a year spent in securing financial support from private foundations, and selecting the Public Affairs Research Group (PARG) of Sacramento to staff the study, work commenced in the Spring of 1980. PARG began by collecting background information for a series of reports on medical practice regulation through history, and as it currently operates in the fifty states. With continuous oversight of its activities by the Board, PARC arranged to conduct three colloquia in the Fall and Winter of 1980, followed by two public hearings early in 1981.

The colloquia examined nine major topics, bringing together recognized experts iii each area. In addition to the principal speakers, groups of panelists were invited to respond to each presentation. The audience was comprised principally of invited guests from all areas of health care delivery and education., consumer groups and government. There was very active audience participation throughout the colloquia. For a list of the principal speakers and their topics, and invited -participants see Appendix I. (Copies of the entire set of PARG reports, including transcripts of the colloquia, are available from Public Affairs Research Group, 1826 Capitol Avenue, Sacramento, CA 95814.)

Following completion of the colloquia, PARC distilled six "Policy Alternatives", from the mass of fact and opinion presented, which it presented as its Report #4. These alternatives were:

1. Deregulation of health care occupations

2. Partial deregulation and substitution of public certification

3. Title licensure (anyone could practice but only physicians could call themselves by that title)

4. Licensure - Status Quo

5. Licensure - Moderate Reform

6. Licensure - Expansion and Unification

For a fuller description of these alternatives, refer to PARC's fourth report. At the public hearings in San Francisco (February 20, 1981) and Anaheim (March 14, 1981), the public and representatives of numerous health occupations and organizations testified on those six alternatives. The hearing transcripts and a summary of the transcripts became reports #5 and #6. PARG later prepared an Inventory of Regulated Health Occupations in California (#7), a set of supplementary studies on health regulation (#8), and then summarized the entire study In Report #9. With completion of the nine reports, PARG ended its direct involvement with the study.

Following the 1981 public hearings, the Board began deliberating the findings of the colloquia, hearings and supplementary reports. Through the summer of 1981, a subcommittee of the Board developed recommendations for action, which were reviewed and modified at several Board meetings.__At the January 1982 meeting, the Board directed its staff to prepare a paper describing several options for action. The "Options Paper" was distributed to over 400 individuals and groups in the Spring of 1982 and comments were invited. After receiving approximately 150 responses, the Board met in June, reviewed the responses, and passed a motion to pursue a proposal which draws from three of the options. This approach includes

1. Redefine the practice of medicine to mean surgery and penetration of human tissues, prescribing drugs,• using Ionizing . radiation, and instrumentation beyond the mouth, anus and vagina.

2. Institute stronger penalties for nonphysicians who perform any of the acts described in #1 except to the extent permitted by other sections of law.

3. Create a program to register health practitioners who are not currently eligible for licensure.

The Board also directed its staff to prepare the present report analyzing the impact of these changes, to be presented to the Board in the Fall of 1982. A fuller discussion of the Board's proposal and its implications follows in Sections II and III of this paper. The reader is reminded that only the Legislature, can institute such changes, and that the Board itself is only proposing possible areas for legislative consideration rather than instituting changes itself.

State of California, Department of Consumer Affairs

PART I: BACKGROUND

A. INTRODUCTION: THE MEDICAL PRACTICE ACT

Section 2052 - Any person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats operates for, or prescribes for any ailment, blemish, deformity. disease disfigurement, disorder, injury, or other physical or mental condition of any person, without having at the time of so doing a , unrevoked, or unsuspended certificate as provided in this chapter, or without being authorized to perform such act pursuant to a certificate obtained in accordance with some other provision of law, is guilty of a misdemeanor.

Section 2052 of the Business and Professions Code defines the practice of medicine as encompassing all forms of diagnosis and treatment of any physical or mental condition, and states that only physicians may practice any activity falling within that definition. The section goes on to exempt persons licensed or entitled by other laws from this restriction, to the extent permitted by the specific law.

This report will examine the impact of Section 2052 on the delivery of health care to the citizens of this State. It will consider the impact of the law on consumers' ability to choose sources of health care outside the orthodox delivery system, and on the ability of alternative practitioners to offer such care. It also will consider the implications of Section 2052 as it affects the further evolution of both orthodox and unorthodox health occupations in the future.

Finally, the report will propose changes in current law to make it more consistent with contemporary systems of health care delivery, and to introduce flexibility for accommodating the dynamic evolution of therapeutics and health manpower in the future.

B. SOME CONTEMPORARY PROBLEMS:

Many people believe that the existing system of health professional and occupational regulation is completely adequate. During the course of its study of Section 2052, numerous witnesses testified, and numerous others wrote to urge the Board to desist from seeking change in the law. Yet many of those who work day in and day out with the system of laws and regulations, and who try to find solutions within the law to problems which could not have been imagined by the drafters of that law, find it impossible to ignore the growing problems with making it work at all. Health care is a dynamic field, one which is changing much faster than the cumbersome legislative process can keep pace with. The expectations of the public about what health care can and should do for them are challenging the ability of the existing system to respond. Likewise, the providers of care are changing in response to the pressures of technology, as well as their own aspirations to higher. status, greater responsibility and more income.

As will be shown later in this report, new health care occupations are emerging at an astounding rate. California now regulates over 60 separate health occupations involving some 713,000 individuals. With each new development in health technology, there is a potential new occupation. While many of these groups evolve in response to a perceived need within the, system, they embark upon a predictable course. Once there is a significant number of practitioners of an occupational specialty, its members begin to form a group Identity. They typically begin to see a need to protect themselves from encroachment by other Individuals and occupations, and begin to work in an organized fashion to enhance their status, working conditions and income. They will assert that their activities are unique, require special training and should be controlled in order to protect their "professional" image and and to protect the public from untrained practitioners. Ultimately, each group will consider licensure as a means of attaining these goals.

A further incentive toward licensure is that under current law, many of the things now being done by unlicensed technicians and therapists are technically illegal. Recalling that Section 2052 says that only physicians can diagnose or treat any physical or mental condition, many of the newer occupations are functioning without legal sanction. Like the members of the occupation themselves, their employers, including most major hospitals, become unsure whether they are breaking the law by permitting technicians to do certain things. Eventually, the questions reach the regulatory agencies and there are no clear answers.

Paralleling the evolution discussed above of "orthodox" health occupations - those who work in the organized health care delivery system there has been a recent explosion of "unorthodox" or "alternative" health practitioners. California has been variously described as being either on the cutting edge or on the lunatic fringe of alternative health care. Although a few such occupations have in the past been licensed, including homeopaths, naturopaths and midwives, there now are dozens of types of nontraditional healers. These will be discussed in more detail later in this paper. The trend toward licensure is demonstrated by three groups in the recent past. In 1976, acupuncturists had become sufficiently visible and organized to gain political support and become a licensed occupation. Proponents of midwifery have introduced licensure bills in every session of the legislature for nearly a decade and it is not unreasonable to anticipate they eventually will succeed. In 1982 respiratory therapists gained full licensure status after an intense lobbying effort. As each campaign for licensure is successful there is even more incentive for other occupations, both orthodox and alternative, to take on the battle.

As health care evolves, another problem intensifies. Aside from esoteric technical specialties such as dialysis, blood gas analysis, electroneuromyography, and so on, much of what technicians and alternative practitioners do is common to many occupations. In their efforts to establish that what they do is unique, and to protect their turf from encroachment by other occupations, practitioners become very concerned with overlapping scopes of practice. Two years before they succeeded in getting a licensure law, respiratory therapists successfully fought efforts by physical therapists to include administration of inhalable medications and postural drainage in their scope of practice. Nurses, nurse aides, physician's assistants and others dispute who can do what to whom, and try to get the legislature to back them with amendments to the law. Nurses recently sought changes in law to permit them to perform psychotherapy and to redefine nurse anesthetists. Marriage counselors are concerned that they cannot call themselves psychotherapists, acupuncturists want to be known as doctors of oriental medicine, podiatrists want to be able to do surgery on the leg, and so on. All of the licensed professions and occupations are worried about the unlicensed people who are doing things they consider as being their own territory, and about how their own scopes of practice might be circumscribed.

In the following pages, these themes and others will be explored more fully, and some of their historical and cultural implications will be examined.

C. THE BASIS FOR LICENSURE: SOME BASIC ASSUMPTIONS

I'll have to say that the number-one obstacle to effective practice is that medicine today is being regulated at almost every turn... The profession must be free to police itself, to set its own standards. Joseph Boyle, Jr., MD

I am cynical about self-regulation. I think the profession should open itself up to external evaluation. Priorities in health care must be set by society, not by the medical profession. William C. Fowkes, MD

As in every other state in the nation, California law has long identified a specific set of activities as constituting the practice of medicine, and has maintained standards for entitlement to practice those activities in the law. While the statute, commonly known as the Medical Practices Act, does not overtly articulate the bases for regulating the practice of medicine, some of the underlying assumptions of the statute can be described. First, the statute assumes, and the courts have affirmed, the right of the state to regulate certain activities. Second, there is an assumption that citizens both want and need to be protected from activities which pose a real or potential threat to public health, safety and welfare, and that the government is mandated by the citizenry to provide that protection. Third, the statute assumes that certain activities are so Inherently dangerous to the public health that only individuals who have met high standards of education and training can safely do them. Few would disagree with these points.

However, certain other implicit assumptions forming the basis for the present system of physician licensure may not be as readily accepted. Among these are the following:

1. That all activities which can be done by physicians under current law are necessarily threatening to public health, safety or welfare and require regulation by the state.

2. That only physicians are competent to perform those activities.

3. That all physicians are competent to perform all activities which the law permits.

4. That only by licensing physicians and other health practitioners can the public be protected.

5. That licensure does indeed assure the public of the competence of licensed practitioners to practice safely and effectively.

The first of these assumptions (that everything subsumed under the current definition of the practice of medicine is inherently dangerous) is patently illogical. The specific language 'of Section 2052 of the Business and Professions Code includes the following phrases; Any person who practices..., any system or mode of treating... any ailment, blemish, deformity, disease, disfigurement. disorder, injury, or other physical or mental condition of any person..." (emphasis added). In reality, the range of activities which can be shown to pose real or potential threat to the public health and safety is less broad than the Medical Practices Act defines.

The Board of Medical Quality Assurance concluded in June, 1982 that there are four major activity groups which are of such high potential public hazard that they require stringent legal controls. These include surgery and penetration of the human skin and tissues; determining the need for and using ionizing radiation; prescribing dangerous drugs; and instrumentation of bodily orifices beyond the mouth, anus and vagina. Various laws currently permit other groups of nonphysician practitioners to perform these activities under various regulatory controls. For example, physician's assistants may perform minor surgery; medical assistants and other unlicensed persons may be certified to take (though not to interpret) x-rays; and nurses and physician's assistants are able to perform certain endoscopic examinations, insert airways, insert IUD's, and perform a variety of instrumentations under certain circumstances. That these exceptions exist does not belie the potential danger inherent in the four listed groups of activities nor the desirability of providing statutory controls over those activities.

This leads to the second questionable assumption: that only physicians are competent to practice the broad range of activities currently subsumed as the practice of medicine. There is no question that medical education in the present century has achieved an admirable level of excellence. Likewise, n& one would seriously question that physicians are the most capable of making the most complex decisions about health care. On the other hand, there are those who question whether the majority of decisions about common

Throughout this paper, whenever the term "dangerous drugs" appears, it has the technical legal meaning of any and all drugs which require a prescription. If another meaning as intended, that will be made clear in the context health related conditions requires the level of education, skill and judgment that a physician brings to decision making. Clearly there are many "medical" decisions that the average lay person can make: minor cuts and scrapes should be washed; ice reduces pain and swelling of a minor bruise, etc.

The third assumption is that all physicians are competent to perform all the activities which the law permits. This assumption Is arrived at inductively by noting that physicians are licensed generically, rather than by specialty, and that the law does not specify that only certain physicians may perform certain activities. In fact, medical science has become so complex and there are so many formal and informal controls on practice no physician is able to do all things the law allows. Hospitals, insurers, peer review organizations, specialty boards, and individual ethics all contribute to assuring that physicians practice within the bounds of their areas of competence, but the law does not require them to do so.

The case for the fourth assumption, that licensure is necessary to protest the public, requires more complex analysis. Throughout the past century a system of formal and informal mechanisms has emerged for assuring the competence of practitioners of healing arts. These mechanisms include the development of widespread standards for practitioner education, including private and public organizations which accredit educational institutions. Similarly, professional associations have developed comprehensive examinations aimed at assuring their members' competence. For many health occupations, including physicians, nurses, pharmacists, dentists, psychologists, physical therapists and others, the private association examinations have been adopted by most or all states as a minimum criterion for licensure. Once a practitioner has competed educational requirements and passed an examination, there are still other mechanisms which contribute to assuring competence and public safety. Health care facilities establish high standards for practitioners to gain staff privileges. Malpractice insurers develop complex actuarial data on which to base the rates they charge for coverage of practitioners. National, state and local professional associations promulgate codes of ethics and standards of practice for their members. Internalized ethical standards and the spectre of public or professional notoriety further serve to minimize substandard care. Finally, the self-adjusting nature of market economics may provide certain assurances that the flagrantly incompetent will not remain in practice for long.

None of these mechanisms provides any guarantee that the marginally competent will be prevented from practicing. Unfortunately, as will be shown later, neither does licensure. It can be argued that most of the mechanisms which contribute to assuring initial and continued competence of health practitioners would continue to operate in the absence of licensure. It also can be argued that licensure does no significantly add to the efficacy of those mechanisms. This, then leads to the fifth assumption upon which the present statute rests and with which some may argue: that licensure assures the competence of practitioners.

While licensure ratifies the judgments implicit in the successful completion of professional education and passing a comprehensive examination, it does not add any significant assurances of competence to these mechanisms. What licensure does add is a means to take legal action against those who practice incompetently or unethically in spite of their success in surmounting the obstacles to entry into practice. While California leads the nation in disciplining physicians. only a small fraction of bad practice ever leads to disciplinary action.

To date, licensure has not incorporated meaningful guarantees that, once admitted to practice, the licensee will continue to remain competent to practice. The only common attempt to assure continued competence has been to require continuing medical education (CME). The effectiveness of CME has been the subject of intense debate for several years. While other techniques of assuring continuing competence have been suggested and tested, none have been implemented on a wide scale. These have included proposals to reexamine licensees periodically- every five or ten years for example: to require periodic practice audits; to create effective self-assessment tools; and to use computer simulations, patient care algorithms and other evaluative tools.

The cost, complexity, and lack of proven efficacy of the quality assurance techniques mentioned above have prevented their Implementation for the foreseeable future. Experts in health law also have raised the interesting question whether it is fair or appropriate for relicensure to be denied on the basis of a standard of knowledge or skill which is more stringent than that in effect at the time of initial licensure. Assuming an effective working life in excess of 30 years, it is highly unlikely, that any physician licensed in 1982 could be expected to be able to pass an examination based on the state-of-the-art in 2012 without considerable study, yet, under the current system. this year's crop of doctors need only pay their renewal fees to practice well into the 21st century.

To return to the more germane issue of initial competence, the Board has heard compelling testimony that there may be only a limited connection between the ability to complete an academic curriculum and pass an examination, and the ability to practice safely, effectively and competently. There is a demonstrable relationship between curricula in medical schools and the content of the National Board examination. What appears to be missing is the ability to accurately measure clinical competence, and to predict who will be a good practitioner. This stems, at least in part, from the propensity of exam developers to draw upon academicians for material. Another contributing factor is that it is far easier to develop so called "objective" questions (those which can be easily formatted :into true/false and multiple choice questions) from factual information than from the domains of affective skills, analytical , judgment and intuition. Yet it is in these subjective capacities where the critical differences between a knowledgeable scientist and a gifted clinician lie. Licensure examinations may be able to test for the science of medicine, but not for the art.

To summarize, the question has been raised whether the current definition of the practice of medicine, as contained in Section 2052 of the Business and Professions Code, is an appropriate mechanism for the regulation of health occupations. Is that definition so broad and all-encompassing that it exceeds the implied mandate of the state to protect the public health, safety and welfare? Does it instead preclude the rational sharing of the delivery of health care services among a wide variety of individuals and occupations who may be fully capable of providing many of those services in a safe and efficient manner? Finally, at what point do the rights of the citizens to choose the sources and types of health care they receive outweigh the state's implicit mandate to provide public protection through restrictive licensure mechanisms?

D. GOALS OF LICENSURE

Licensure ostensibly is designed to protect the public from harm. Major objectives of this goal include: prevention of physical or economic harm resulting from incompetence or unprofessional conduct and prevention, of fraud including quackery, charlatanism and misrepresentation. A recent objective has been to provide quality assurance, which may be viewed as an extension of preventing incompetence. Other objectives include preventing delay in receiving efficacious treatment, which usually is seen as prohibiting the use of unorthodox or ineffective treatment. A related objective is to provide the consumer with a surrogate (the state) which is assumed to have special expertise in determining who is competent to practice, and which also has the resources to take action when harm occurs. Licensure presumes that most people either do not want to, or are incapable of, making decisions regarding their selection of health care practitioners, so the state substitutes its expertise for that of the inexpert lay person.

Historically, the foremost advocates of licensure have been the members of health professions themselves, not the citizens they serve. It has been said that the reasons for state regulation have had less to do with meeting the goals and objectives described above, than with being responsive to the aspirations of the professional associations. While the professional associations used public protection to justify the need for licensure, the more immediate motivations appear to have been gaining control of health care delivery, eliminating competition., restricting supply, acquiring the mantle of orthodoxy and assuring desirable levels of reimbursement.

Seen from the consumer's perspective, licensure also has meant that choices have been limited to selecting between a small number of primary practitioners: physicians, osteopaths, chiropractors and in a few states, naturopaths and homeopaths. Most other licensed professions work under the direction or supervision of physicians and rarely have independent access to patients. The boundaries of orthodox medicine are formally defined, in part, by the mechanisms of licensure: scope of practice, education requirements and standards of practice. Even if a consumer cannot find a licensed practitioner which will provide certain techniques, a nonphysician is prevented from offering them. For example, consumers seeking access to home birth or midwives, orthomolecular medicine, therapeutic massage and other "unorthodox" health practices generally have been forced to seek out unlicensed practitioners. The state does not directly prohibit citizens from utilizing unlicensed practitioners; instead, it uses its police powers to prevent such practitioners from practicing openly. Regardless, the effect of this regulatory approach is to prevent people from employing unlicensed practitioners to provide services which they may wish to receive, and which they believe may help them. The state assumes the role of a benevolent, but nonetheless paternalistic, gatekeeper for access to practitioners and techniques.

At this point it is relevant to review the rationale which is used to justify licensure of an occupation. In its 1977 report "Credentialing Health Manpower" the federal Department of Health. Education and Welfare proposed a set of criteria for assessing whether an occupation should be credentialed (licensed or otherwise regulated). The HEW criteria are:

-In what way will the unregulated practice (of the occupation) clearly endanger the health, safety and welfare of the public?

-Is the potential for harm easily recognizable and not remote or dependent on tenuous argument?

How will the public benefit by an assurance of initial and continuing competence?

Can the public be effectively protected by means other than licensure?

Why is licensure the most appropriate form of regulation?

How will the newly licensed category impact upon the statutory and administrative authority and scopes of practice previously licensed categories in the state?

Some related criteria for licensure were proposed by the Council of State Governments:

-Does the health occupation have a scope of practice with unique qualities that distinguish it from other occupations?

-Is there a sufficient demand for the services of the occupation?

-Is there no adequate substitute for the services of the occupation?

The first two of the HEW criteria are the most critical, since without clear danger to the public, there may be no basis for any form of regulation The other criteria are not sufficient to justify licensure unless there is such a danger.

State governments use a number of methods to regulate health occupations. These include licensure, certification, title licensure and registration. Each term has a different meaning in various states, but for the purpose of this paper, the definitions in Appendix II will be followed.

 

Briefly, these are: Licensure: comprises use of educational, experience and other requirements, plus a state examination to determine competence, and specifies a scope of practice exclusive to the group. Certification: may or may not include a state exam. education or experience standards; often relies on examinations or other standards established by private agencies or associations, which the state accepts and endorses. May or may. not include an exclusive scope of practice. Title Licensure: permits anyone to practice an activity or scope of practice, but only licensed individuals may use a specific title. Registration: may impose few or no entry requirements to practice. Often consists of nothing more than maintaining a list of individuals who are "holding themselves out" as practicing a specified occupation.

 

The HEW report urges states to impose the least restrictive level of credentialing which is consistent with the potential hazardousness of an occupation. For example, if an occupation such as Physical Therapy Aide works only under direct supervision, does not prescribe, diagnose or do invasive procedures, it is inappropriate to require them to be licensed. If regulation is needed at all, registration probably would provide adequate public protection by limiting scope of practice, setting standards for supervision, and providing a legal basis for disciplining aides who exceed their limits.

 

E. THE CURRENT SYSTEM OF REGULATION OF HEALTH OCCUPATIONS

 

If there were an end to licensing, now, I doubt that

it would make any difference. I think that control by licensing is largely irrelevant.

Paul Starr, Ph.D.

 

I think that there is a tremendous gap between

what licensure purports to do, and the reality of

the situation. We do not have in licensure a quality

assurance system.. .a system based on competency...

a system that is based on actual outcomes of care.

Mark Kleiman

 

While regulation of health professions and occupations has become extremely complex, it is useful to separate the system into two main divisions: the public and the private systems.

 

1. THE PUBLIC SYSTEM: GOVERNMENTAL REGULATION

 

The principal component of the public system is various licensing boards and committees which establish, to a greater or lesser degree the requirements an individual must fulfill to be considered competent to practice a given profession or occupation. At present. there are nine healing arts licensing boards in California, and under the largest of these, the Board of Medical Quality Assurance, are seven examining committees for allied health occupations. Altogether, California's licensing boards and examining committees license, certify or register approximately 485 ,000 individuals in 32 health professions and occupations. (See Table I for detailed data on the numbers and types of occupations, the sizes of the licensing agencies, and the budgets of the agencies.)

In addition to reviewing academic credentials, training and experience, administering or contracting for examinations and issuing licenses, these agencies may also approve or certify schools and training programs , set standards for and approve continuing education programs, and discipline licensees. In recent years, a few pilot programs have emerged within boards and committees to explore other means for assuring continuing . and to rehabilitate impaired practitioners.

In recent years both the courts and unsuccessful competitors have questioned the appropriateness of certain widely used licensing examinations. Even as prestigious an examination as the National Board exam for physicians has been challenged. The central questions raised have been whether the examination is job-related. (that is, are the questions directly relevant to the activities which practitioners actually do), whether it is valid (a psychometric term for how well the questions measure specific knowledge or ability) and whether It is reliable (consistently able to discriminate between those who do or do not know a particular unit of knowledge). These criteria are particularly critical in instances where certain groups such as minorities and women consistently do less well than others. If the agency cannot demonstrate its examination is job-related, valid and reliable, it may be forced to discard the exam and develop one which meets those tests.

Examination development has become an extraordinarily expensive process. Boards which once relied on volunteer professional experts -primarily from academic backgrounds - to write questions, now may have to resort to costly examination services with resources to perform complex job audits and validation studies. The costs of these activities must be passed on to applicants for licensure, and usually to those already licensed through increased renewal fees. As already discussed, assuring continued competence is stall very much in it infancy, and if it is to become effective and widespread, a great deal of money will be needed.

The third responsibility of licensing agencies along with reviewing credentials and administering examinations, is to enforce scopes and standards of practice. Historically, enforcement has not been heavily emphasized. The reasons for this are diverse. Until 1976, healing arts boards in California were made up almost exclusively of members of the regulated occupation. There is an understandable reluctance to aggressively pursue one's peers for acts which (perhaps) could just as easily have happened in one's own practice. As a result, until recently only the most notorious cases ever reached the level of board disciplinary action. As the legal system has become more complex, the time from commission of a negligent, incompetent or immoral act to the imposition of discipline against a licensee has stretched out to as long as five years. Disciplining a licensee is a very expensive process.

In California, as in most other states, licensing boards receive all their funding through licensure fees. The ability of a board to effectively assess initial competence, as well as assure continued competence and discipline errant practitioners, is closely related to the amount of fees it is able to collect, and this in turn hinges on the number of potential licensees in the occupation being regulated. While nursing and medicine comprise very large groups, and produce large pools of fee revenue, occupations such as podiatry, osteopathy and speech pathology involve very small numbers of licensees and therefore have small regulatory budgets.

Considering the costs of licensing health occupations, of assuring their continued competence to practice, and of disciplining serious violations of the law, the questions emerge: is a licensing board really able to protect the public? Is licensure really able to assure that practitioners are competent to practice at the outset, let alone a number of years later? Is there a point at which the cost of licensure exceeds the presumed benefit to the public?

Returning to the question of the scope of practice of physicians, the point was made above that violations of Section 2052 are common. If every violation of the section were reported to the BMQA, the Board would be inundated with complaints. The bureaucracy necessary to investigate that many complaints probably would be enormous. Clearly it would be preposterous to enforce the letter of the law. It would be absurd to arrest every hospital employee who performed a routine patient care function commonly accepted as appropriate for unlicensed staff yet technically violating Section 205.2. If the law was. enforced in this instance, every hospital would be forced to close. It would be incomprehensible to insist that only a physician could do all the activities which currently are done by ancillary occupations -- both licensed and unlicensed. Yet this is exactly what currently law requires.

In addition to the licensing boards, under the Department of Consumer Affairs, the Department of Health Services regulates several occupations including X-ray and laboratory personnel. Many others are not directly regulated, but must meet certain governmental standards in order to practice in licensed health facilities. This category includes such occupations as medical record technicians, nurse aides, occupational therapists and cardiopulmonary technologists. In general, the standards used are those of a private professional association which are incorporated into state regulations by reference. Administration of the requirements is the responsibility of the employing hospital or other health facility, under the general oversight of the State Division of Licensing and Certification, and the Joint Commission on Accreditation of Hospitals.

Another group of occupations has standards for training established in law, but there is no direct or indirect regulation. of individual practitioners. These Include medical assistants, hemodialysis technicians, blood gas analysts, etc. A final group is regulated by local jurisdictions, and includes ambulance attendants (emergency medical technicians I and II) and paramedics. While there are state laws affecting training programs for these occupations, the actual standards of training and practice are established by local governmental bodies.

2. THE PRIVATE SYSTEM: PRIVATE CONTROLS ON HEALTH CARE DELIVERY

In addition to governmental regulation of health care personnel, there Is a private system which has evolved in response to specific needs. Admittedly, the myriad public and private protection agencies are most effective with respect to physicians. At present, other health occupations have neither developed as sophisticated a set of controls over their own practitioners, nor become the object of external control systems to the degree that physicians have. However, these controls are emerging and being refined.

Perhaps the oldest element of the private system is professional associations. In the early days of licensure, medical associations often were virtually indistinguishable from state licensing agencies. The associations provided state governors with names of prospective board members, proposed standards for licensure anti practice which generally were adopted, and were involved in discipline of practitioners.

While the relationship between the state board and the association is no longer that intimate, at least in California, the medical association still plays a significant role in both the private and public regulatory systems. At local, state and national levels; the professional associations are deeply involved in influencing legislation affecting health care and registration of practitioners. Associations have affected such areas as scope of practice, informed consent, continuing education, human experimentation. and patient's rights through lobbying and similar activities.

As mentioned above, professional associations have played the central role in developing examinations which have become the standard for licensure. Specialty societies go far beyond the government in determining criteria for specialization in medicine, and have been so effective In this domain that there has been little serious consideration given to specialty licensure by the states.

In the recent past, the California Medical Association has worked closely with the BMQA in the areas of physician responsibility and rehabilitation of impaired physicians. In the former case the CMA jointly published a booklet with the Board outlining physicians legal and ethical responsibilities for involving themselves when they are aware of questionable practices of their peers. In the latter case. component (local) medical societies. the state association and the BMQA have developed a variety of programs to assist physicians with substance abuse, mental and physical impairment problems. These programs focus on support and rehabilitation rather than punishment and have been quite successful.

Local component medical societies also have peer review bodies which provide oversight over association members. If a member is found to diverge dramatically from the community standard of practice, ethical behavior or competence he or she may be counseled by peers in the local society, or in extreme cases excluded from membership. Professional ostracism by a medical society can severely hinder the ability of a physician to gain or retain staff privileges in hospitals.

This next element in the private system is perhaps the most critical test of competence aside from completion of medical education. Especially since the so-called malpractice crisis of the mid-1970's, hospitals are increasingly cautious about granting staff privileges. With courts holding hospitals as well as attending physicians liable in malpractice cases, most hospitals are scrutinizing the training experience and reputation of applicants very carefully. As part of AB lxx, passed during the special legislative session of 1975, the BMQA was mandated to collect reports from hospitals, courts, insurers and licensees regarding malpractice decisions, suspension or termination of hospital privileges, and other actions against doctors. The law also requires hospitals to request a report from the BMQA under those sections, before granting or renewing staff privileges for doctors, dentists, podiatrists and psychologists.

In addition to institutional controls over incompetent practice, insurance companies contribute to the informal system in two distinct ways. First, malpractice carriers base their rates for coverage on actuarial studies of the incidence of litigation among the various specialties of medicine. The most. hazardous specialties -- anesthesiology, surgery, obstetrics, and so on -- are assigned the highest rates, while the more benign specialties, such as pediatrics, pay lower premiums. Another private control is that of health insurance carriers, including private companies and governmental programs. By establishing parameters for reimbursement, insurers exert some control over the provision of medically unnecessary or excessive treatment. Most practitioners will not provide a service for which they are unlikely to be paid.

Among other private or non-governmental controls over health practitioners a recent entry in the field is the National Commission for Health Certifying Agencies. The NCHCA was created to set standards for organizations which privately certify health occupations. The private organizations are those which give examinations, set training criteria, and otherwise certify that individuals are competent to practice. The NCHCA is e voluntary association of such organizations which is striving to assure the certifying organizations are equitable, free of domination by special interests, and use objective criteria in their certifying activities. Since more and more private examinations and certifications are being accepted by state and federal governments as the basis for licensure, reimbursement under government plans, or access to hospital employment, it is essential to assure that these certifications are a reliable, nondiscriminatory test of competence. NCHCA has raised the awareness of associations, and has made initial gains in eliminating credentialing bias.

Finally, consumers themselves provide some influence over health practitioners, both individually and through consumer organizations. As noted briefly above, consumers are becoming wiser about health care, and more critical in their choices of practitioners. With broader dissemination of information about illness, prevention, alternatives to conventional treatment (such as non surgical treatment of breast cancer), and a growing unwillingness to accept the decisions of doctors without question, patients are taking a much more active role in their own care. When patients feel their care is not up to community standards, they are more willing to seek redress from medical societies, governmental agencies or the courts.

To reiterate, the PRIVATE SYSTEM of controls over health care practitioners exists outside of, and more or less independent of, governmental controls and includes professional associations, specialty societies, impaired physician programs, hospital staffs, insurers, private certifiers and consumers. Even if all licensure were abolished, it is highly likely these controls would continue to operate. Indeed, in the absence of licensure by the state, it is likely that non-governmental controls would become more sophisticated, and in the final analysis might be even more effective than the existing regulatory schemes. It is certain, for example, that hospitals would assure that physicians applying for staff privileges had met high standards of education, training and experience. Insurers would. continue to have criteria for who could bill for what services, just as they do now. Professional associations - probably would develop some form of certificate of competence to replace the current stare license, and in all probability, the same kinds of practitioners would continue to give the same kinds of care to the same patients, whether or not licensure existed. Undoubtedly there would be a wide range in the types and effectiveness of private sector controls which would evolve, but it seems safe to predict that if licensure were eliminated a vacuum would not be created. Regardless, this is not what is proposed in this paper. Even though the evidence that licensure is essential to protect the public is arguable, it is a system which has been around for quite awhile, is familiar to most people, and by most accounts does nor do more harm than good.

F. ALTERNATIVE PRACTITIONERS

In the past two decades there has been a growing trend toward individuals assuming greater responsibility for their health care. The popularity of alternative modes of health care has grown in part from dissatisfaction with invasive and sometimes dangerous medical techniques, and a preference for methods which emphasize the body's innate healing abilities. The popularity of alternative therapies is also an expression of a preference for a different type of relationship with practitioners - one in which patients take more active roles.

G. THE ISSUE OF FREEDOM OF CHOICE

There is an incompatible tension between the state's obligation to protect the public from harm and the public's right to freedom of choice. In 1914, Supreme Court justice Cardozo authored an opinion that the right of privacy included the right to determine what medical procedures are performed upon one's own body (except if it can be shown that the person is unable to make a choice, e.g., an insane person or a minor), and thereby established the right of self-determination. The Cardozo opinion dealt with the right to refuse medical treatment. Self-determination under this opinion does not extend to choosing who may provide treatment; that right to choose is not firmly established in case law, although it can be viewed as a further extension of the constitutional right of privacy.

Subsequent to the Cardozo opinion, proponents of Christian Science successfully fought to have their religious practitioners exempted from licensure requirements. They argued that since their faith did not attribute the causes of disease to physical phenomena, it was irrational to require Christian Scientists to be trained as physicians and be licensed in order to serve as healers. In the course of the debate, they argued "The question whether Christian Science is more or less efficacious or beneficial than the medical and surgical system is one which no group of citizens should undertake to decide for another. It is a question which each citizen is at liberty to decide for himself." (Smith, 37)

They maintained that the grant of a state sanctioned monopoly (through licensure of some groups and prohibition of the practice of others) would lead to a deterioration of medical science iii the absence of competition, and would stifle innovation and improvement. Finally, they posed a question which is being echoed by contemporary unlicensed healers:

If human law should declare that none but medical doctors may endeavor to relieve, human suffering it then would be criminal for a man whom they cannot heal to attempt to obtain relief through the practitioners of any other system. The members of a legislature who vote for such a law will thereby unite in saying to every man whom the medical doctors cannot heal. 'The medical system is the state system of healing; if it cannot cure you, you must be deemed, in point of law, to be incurable.' (Smith. 71)

While exemption of Christian Science healers from licensure was based on religious freedom, the points they argued are equally relevant to non-religious beliefs about heath. The central question is whether the state should compel people to choose one system of treatment over another that the person prefers, regardless of the basis for that preference.

A recent development in the evolution of freedom of choice came with the 1980 Texas court ruling known as Andrews vs. Ballard. Texas law at that time gave physicians the same sort of unlimited domain as Section 2052 provides in California. The state Board of Medical Examiners (BME) interpreted that law to permit only licensed physicians to practice acupuncture. The court ruled that because acupuncture is not derived from western scientific concepts of medicine physicians have no inherent special expertise in the field. "That they should also control access to nonmedical health care techniques based on principles unknown in their , and in which they are entirely unschooled seems senseless." The court "specifically rejected the notion that the constitutional right of privacy extended only to the choice of a safe and effective form of treatment." (emphasis added). Witnesses in the case testified that there was no physician practicing acupuncture in Texas, and of course that no non-physicians were permitted to practice. Thus, the Texas BME ruling, regardless of its intent, effectively made it impossible to secure acupuncture treatment in the state. The court found that the BME's assertion of the need to protect the public did not outweigh the public's right to privacy and freedom of choice. (Schwartz, 5-7).

 

H. FREEDOM OF CHOICE AND INFORMED CONSENT

In order to effectively exercise freedom of choice, citizens require two tools: knowledge, and the ability to consent to treatment as informed collaborators in their own care.

Historically, professionals have closely guarded the 'secrets" of the profession, and have assumed that their clients did not need or want to know, and could not understand most of what went in to making professional decisions. However, public education and communications have changed the level of public interest in, and ability to understand the old secrets. Even if it ever was true that a person of average intelligence would be incapable of understanding enough about his own condition, and what treatments were available, at what risk or probability of success, that assumption is no longer supportable. In the last quarter of the 20th century, the right to know, and the right to consent to treatment have become central to the relationship between healer and patient.

There are two distinct and not yet reconciled judicial views of informed consent, which are followed in different jurisdictions. The "professional standard" test requires physicians to disclose the nature of the ailment, the possibility of success, the risks 01 unfortunate results, and alternative treatment (including non-treatment). The standard for the extent of disclosure is that liability is determined by comparing what the defendant (physician) did with what a reasonable, prudent practitioner would have disclosed in the same or similar circumstances. This standard established that it is the physician's judgment of what constitutes a "material risk" that determines the extent and content of disclosure.

The other standard is based on the patient's need to know, and requires the physician to disclose information sufficient to enable the patient to understand materially relevant and significant factors upon which to make an informed choice. Thus, the patient becomes the final determiner of how much information is enough.

Some physicians may be reluctant to surrender control over decision making, partly for fear patients will make "bad" decisions which then will be held against the physician. Physicians often are concerned that patients will be frightened or overwhelmed if given too much information, or will refuse to take responsibility for making decisions. However, a patient may legitimately choose to decline receiving information, and defer to the knowledge and judgment of the physician.

Once a physician makes a determination as to what risks and benefits exist, he or she then must determine which of these to disclose by deciding what is material to the patient. In this process, the physician ceases acting as a scientific expert. Assigning values and disvalues to particular risks and benefits is not primarily an exercise in medical expertise, and the final decision necessarily rests in the patient's hands. Different patients will assign very different values to the same situations and risks. Depending on the person, the nature and effects of the disease, patients may take varying degrees of responsibility for decision making. The fact that many patients decide to give their doctors carte blanche to determine treatment and to effect a cure is not an argument that informed consent is unnecessary. The physician still has an ethical, and now a legal, obligation to offer patients as much information as they are able or willing to accept:

In summary, freedom of choice and self-determination are meaningless unless patients have reasonable access to knowledge. Informed consent relies on providing the patient with enough information to make a decision about his or her care. Of the two common standards used by courts, the "patient's need to know" test provides a higher degree of self-determination, yet as with the "professional standard' test, the physician still has primary control over determining what information is provided. Regardless of whether a patient is willing to exercise the decision-making prerogative or defers to the physician's judgment, and regardless of whether the physician agrees with the patient's decision, the obligation to inform, and to allow for choice remains.

Part II A Proposal to Revised the Medical Practices Act

A. SUMMARY OF PROPOSAL

As summarized briefly in the introduction to this paper, the Board directed its staff to develop and analyze a proposal which would accomplish three particular things: 1. revise Section 2052 to narrow the definition of the practice of medicine so that the exclusive scope of practice for physicians would comprise surgery, tissue penetration, prescribing dangerous drugs, instrumentation beyond superficial orifices, and use of ionizing radiation; 2. impose more stringent penalties for violation of the medical practice act; and 3. create a registration program for persons who are not currently eligible for licensure.

In this part of the report we will discuss what the various elements of the proposal are, and what they are intended to do. The actual language of this proposal is contained in Appendix IV of this paper, in the form of a legislative draft.

Section one of the draft is a preamble and statement of intent which recognizes the limits of the state's mandate to interfere in the decisions which citizens may choose to make about their own health, and the practitioners they seek out to care for them.

Section two contains the revised language of the existing Section 2052, and includes the four areas of activity which would be permitted only for physicians and other licensed health professionals. In developing this proposal, the staff concluded that diagnosis of disease can not be excluded from those activities which are so inherently hazardous that the state must surely regulate them. The potential peril to patients, either from incorrect diagnosis, or outright failure to diagnose, is so great that it seems unconscionable to permit persons with little or no training to undertake the responsibility for diagnosing. For this reason, the draft includes diagnosis of disease, injury or disfigurement in the revised section. Again, this proposal would not limit in any way what physicians would be permitted to do.

The essence of what is changed from the current language of 2052 is that treatment of physical or mental conditions would no longer be illegal, so long as it did not violate Section 2052. Taken to its logical conclusion; it would no longer be necessary for other professions, such as nurses, physical therapists, audiologists and others to be licensed to practice much of what currently. constitutes their professions, since they would not be doing things which currently require legal exemptions from the Medical Practice Act. The proposal does not, however, attempt to change any of the current licensure requirements for such allied health professions and occupations. It still would be necessary for a person to be licensed in order to use those titles, or to do those activities which would constitute the practice of medicine under the new Section 2052, but which may be performed by allied health professions under other licensing laws.

As will be discussed more fully in the next part of this paper (Part III), many employers still would rely on licensure to assure that their employees meet standards of training and competence which are currently associated with possession of a license. However, this would no longer be mandatory, since anyone would be permitted to provide most forms of treatment so long as they were registered as health care practitioners.

The third section of the proposal further defines illegal acts, and Imposes fines up to $5,000 and/or imprisonment for up to one year for violations of Section 2052 which result in serious harm to patients.

Section four of the proposal is the Health Practitioners Registration Act, which establishes a program to register currently unlicensed practitioners. This proposal will be examined in greater detail below. As drafted, the proposed Health Practitioner Registration Act consists of a new chapter to the Business and Professions Code, comprising six articles.

Article 1 includes a statement of who would be eligible for or required to register; exempts religious and psychic practitioners; prohibits unregistered persons from claiming to be registered; and defines certain terms in the act, such as "registered health practitioner" "patient" and "treatment". This article also makes it clear that health practitioners cannot represent themselves as being doctors, as being licensed, or as being registered in some specific "professions" (i.e. "registered massage therapist").

Finally, the article prohibits registrants from using degrees or titles unless they have an earned degree from a recognized educational institution. By "recognized," the article specifically means schools approved by the Superintendent of Public Instruction, or accredited by a national accrediting body. The article specifically prohibits using terms such as doctor, M.D., etc.

The second article contains sections which create a Board of Health Practitioner Registration in the Department of Consumer Affairs, consisting of eleven public members appointed by the Governor. It sets terms of office, qualifications of members, staffing, and other structural requirements for the board. The board is empowered to adopt regulations, hold meetings, establish rules of conduct for registrants, and conduct consumer education activities.

Article three sets the standards for registering as a health practitioner. As proposed, applicants would be required to complete a detailed disclosure of any education, training and experience which they have, and which they believe qualifies them to practice some health occupation. Education, including seminars and workshops. would have to be documented through transcripts, certificates of completion or other means. The application also would include a detailed description of what treatments, modalities or other activities the applicant proposed to use, and an explanation of the theory or philosophy on which these are based. If the applicant belongs to any occupational association, he or she would be required to provide proof of membership and information about the purposes and standards of the association.

In addition, the applicant would be required to prepare a patient disclosure package including the above information. Prior to treating any patient, each registered practitioner would be required to provide the patient with a copy of the disclosure, and also gain written consent to treatment. Both the patient disclosure information and the consent to treatment documents would include specified language advising the patient that the state neither evaluates nor endorses the competence or activities of the practitioner, and advising the patient to consider conventional licensed professionals if any pathology or symptoms of serious conditions are present.

The notice to patients would inform them that registered health practitioners are prohibited (under Section 2052 as revised) from diagnosing disease, injury or disfigurement and would suggest that if they wish to have a condition diagnosed they should consult a licensed person who may do so. The patient also would be advised that by signing the consent he or she does not become obligated to accept any treatment from the registered practitioner.

The article ends with a notice which would be required to be-posted in each practice location informing consumers of their right to request Information or file complaints with the Department of Consumer Affairs.

The fourth article contains a listing of activities which would constitute unprofessional conduct, which would be grounds for disciplinary action against the registrant. These include performing any of the activities reserved under Section 2052 (as revised), false or misleading advertising, immorality relating to the practice of the registrant, failure to provide each patient with the required disclosure, misrepresentation of credentials, fraud or dishonesty, patient abuse and other activities.

Article five contains fiscal provisions, establishing a special fund for deposit of fees and fines, and continuously appropriating it far the program. The article also lists fees for application, registration, renewals and delinquent renewals. The fees are set within limits, and the board of registration would have authority to adopt specific fees within those limits.

The last article makes violation of any provision of the act a misdemeanor, provides for penalties including fines and imprisonment for violations, and describes the due process provisions of law. It gives the board of registration authority to deny applications for unprofessional conduct or other unlawful activities, and provides for securing injunctions when the activities of a registrant pose a clear and present danger to the public.

B. DISCUSSION OF PROPOSAL

One of the major considerations in drafting the proposal was determining who would be required to register, who would be permitted to register, and who would not be affected by the changes in law. Two groups can be easily identified, those who would be required to register and those who would not be affected. In the first case, any activity which would violate current restrictions in law - that is, any activity which involves treating or diagnosing any physical or mental condition would require under this proposal either licensure under some other provision of law, or registration under the new law. In the second group, any activity which is currently legal for anyone to do would not be affected by the change.

For example, a person who gives nutritional advice, but does not diagnose or offer to treat it, currently may do so under Section 2068 of the B & P Code. Such a person would nor be required to register under the new law. Likewise, persons who administer massage, who give non-therapeutic counseling, who offer psychic guidance, or who guide people in healthful living activities are exempt from restrictions now and would remain so under this proposal. On the other hand, if a person offered to treat pulmonary insufficiency with exercise, back pain with massage, mouth sores with diet or vitamins, or depression with guided imagery he or she would be holding themselves out as treating specific conditions, and would be required to register.

There remains a gray area of activities which may or may not constitute treatment. In order to avoid an endless process of creating lists of such activities and occupations, which would necessarily require adoption of regulations, the proposal leaves this issue open-ended. It is intended that if a practitioner wishes to be registered, and identifies him or herself as a health practitioner, the board would permit the person to register. We assume that an individual who is not providing health care will be deterred by the cost of registration, and by the requirements for disclosure and patient consent, and that few if any will register for frivolous reasons. Conversely, the penalties for practicing without license or registration will deter practitioners from practicing without legal sanction. For those who are serious about engaging in alternative systems of health care, the incentive to register is that they then would be able to pursue their activities openly, to advertise, and in some instances to have opportunity to prove the merits of their activities. For those systems which may be without any real value, exposure to public scrutiny may hasten their demise.

The proposal also does nor specify any scopes of practice, categories of registration, or standards of competence. The reasons for this are twofold: first, as the background narrative and Appendix III demonstrate, there are dozens of alternative healthcare systems, many of which do not lend themselves to any kind of grouping. Efforts, to circumscribe practice into categories would lead to tedious listings of activities and standards. Each list would inevitably leave out someone or something, and there would always be applicants who did not Lit into any existing category. Secondly, in order to establish standards of competence, there must be fairly broad agreement on several issues: what does the practice consist of; what tasks, activities or modalities are involved; what cognitive and affective knowledge and skills are critical to being able to do those things; what are the consequences of lack of those acknowledges and skills; are those consequences sufficiently hazardous to make the absence competence critical; what educational or training experiences are essential to attaining competence, and are there viable alternatives; can competence be measured, and if so how; who is competent to make valuations of the competence of practitioners; how can outcomes of treatment be evaluated; and, finally, if all of these and other questions could be answered, would the overall effect be to provide greater protection to the public without simultaneously intruding into consumer's freedom of choice in precisely the manner which this proposal seeks to avoid?

There are no correct or agreed-upon answers to these questions with respect to alternative health practitioners and practices. In keeping with the overall intent of this proposal, we return to an open-ended model in which practitioners define their own activities, verify any education or training they may claim to have, disclose what they intend to do, and permit consumers to make informed choices. By accepting treatment, the consumer implicitly accepts responsibility for the consequences of his or her choice, unless the practitioner willfully misrepresents fact, performs prohibited activities, or practices dangerously beyond the limits of his or her training. As was discussed in the background narrative, there are parallels to this approach in every existing practice act. For example, there is nothing in law which prohibits physicians from doing things which they have not been trained to do; the state can typically intervene only when harm has resulted and then only when the case involves gross negligence, incompetence or other defined unprofessional conduct.

Another critical aspect of this proposal emerges here: at present, the state has only shadowy knowledge of who is practicing alternative healthcare. By requiring practitioners to register, and by assuring that their patients know who to turn to with complaints or questions, protection of the public may be enhanced immediately. By providing for grounds for discipline, and setting penalties for dangerous, unethical or fraudulent practice, the state gains the ability to act aggressively against practitioners who harm people. The spotlight of public awareness, and the power to police their activities may serve to make alternative healthcare safer. Within the model proposed, the role of the board of registration would be to review applications for completeness, accuracy, and compliance with the requirements for disclosure and patient consent to treatment. While no specific education or training is required for registration, the board would determine whether any training listed was actually received (through transcripts or other documentation), and whether the representations in the application are factual. The board would not attempt to determine whether there is any scientific or other validity to the activities the applicant proposed to undertake, but could take action against a practitioner who did things which were not included in the application. That is, if an applicant said he or she would be doing only massage and exercise, and then began treating dietary deficiencies without filing an amended application, it could be grounds for board action.

An issue which led to lengthy dialogue during the preparation of this paper was whether registrants would be permitted to perform health or related 'assessments". In a technical sense, it is essentially impossible to commence any form of treatment without either a diagnosis (specifically prohibited to alternative practitioners) or some kind of assessment of the patient's condition. As the proposal emerged, the approach was to prohibit diagnosis of disease, injury or disfigurement. Beyond this condition, nothing in the proposal would prevent a registered practitioner from assessing the condition of a patient, and offering treatment on the basis of the assessment.

Admittedly, some difficult definitional problems are raised here. The general guideline adopted in this proposal is that to diagnose a specific disease injury or disfigurement using the terms of traditional, scientifically based medicine would be prohibited for registered health practitioners. On the other hand, to label or characterize a general condition using alternative, nontraditional or nonmedical terminology would be permitted (e.g. the patient has an energy imbalance, a blocked chakra, etc.). Additionally, it would be permissible for a registered health practitioner to treat a disease or medical condition diagnosed by a licensed individual acting within the scope of their own license, and it also would be permissible to treat a set of symptoms without arriving at a diagnosis.

An example of this latter distinction might be the practitioner who learns that the patient has a diet low in fresh fruit and vegetables, complains of constipation, and bleeding gums. The practitioner suggests that increasing the intake of B-complex and C vitamins and crude fiber is often good for relieving such symptoms, and the practitioner recommends taking a vitamin supplement and increasing the intake of fruit and vegetables. None of these activities would violate Section 2052 (as revised). The practitioner has not diagnosed beriberi, scurvy or colonic cancer, or even a vitamin deficiency, but has merely recommended dietary changes.

Admittedly there are many possible scenarios where it would be difficult to draw a precise line between diagnosis and assessment. It is the intent of this proposal to set forth some general guidelines and allow actual practice, case law, etc. to provide further distinctions as needed. It also is the intent of this proposal to allow for differing philosophies of health, and for differing approaches to treatment. If any general assessment is prohibited, then the proposal loses all meaning, and the opportunity for increased freedom of choice and access to alternative practitioners is lost.

PART III. IMPACT OF PROPOSAL

Two broad generalizations need to be made about the proposal outlined in the previous pages: that no accurate estimate can be made of the economic impact of the proposal, and that only very general statements can be made about the social and professional ramifications of change of this sort. In the first instance, since there are no accurate data on the numbers of people who currently are being treated by alternative practitioners, nor on what they are paying for those treatments, no one can say what the change in these data might be if such practitioners were registered and could practice openly. The factors which affect the costs of health care are so complex and are changing so rapidly in the existing health care system that it is essentially impossible to assess what factors would change, in what ways, to what degree, and at what cost or savings in overall health care dollars. It can be argued with equal fervor that aggregate health care costs will be driven up by duplication of services and delay of care until patients conditions deteriorate; or, that aggregate costs will drop as patients select less expensive treatment modalities and iatrogenic problems are reduced.

More specific comments are possible with regard to the social and professional impact of the proposal if it were to be implemented. In general, it is highly likely that most patients would continue to see the same kinds of practitioners, whether licensed or registered, as they now select. Institutional care would continue to evolve, and private sector influences would continue, and probably gain strength as competition for scarce health dollars and finite numbers of patients increased. In as little as twenty or thirty years, computer and communication technology may so alter the ways in which people react to their own health conditions that much of what we now consider central to health care may seem as antiquated as leeches. It does not seem outlandish to envision home computer programs which could diagnose most common conditions, provide self-care regimens and warn people when it is appropriate to consult a physician. A Medical Board in 2010 may face such issues as whether it is a violation of Section 2052 for Atari and Apple to market diagnostic software to the general public. The past few decades have witnessed a clear change in emphasis from infectious disease management to care of chronic and degenerative diseases. Any change in health care regulation in the 1980's will be only a step in a continuing process of evolution in the healing arts.

Even so, some immediate effects of this proposal can be postulated. The following pages suggest how the two main elements of the proposal would affect various segments of the health community.

III IMPACT OF THE PROPOSAL:

ON PHYSICIANS

Perhaps the most common misapprehension among the responses to the Board's March 17, 1982 Options Paper was that the proposed amendments to Section 2052 would restrict physicians to doing only the four activities named in the second option: surgery, prescribing, radiation and instrumentation. This is neither the intent nor the effect of the proposal. Nothing in the proposed revision of this section would change what physicians can do now.

So what would the impact be? For licensed physicians themselves. little would change. The proposal would make no change in the requirements for education, examination, licensure or scope of practice. For those who choose to practice as physicians, the requirements would be the same. Further, existing private sector controls - hospital privileges, insurance reimbursement, specialty board certification, peer review and so on - would be unaffected by this proposal.

The significant change for physicians would be that they no longer would have exclusive right to practice numerous activities which currently are reserved to them by Section 2052. Even so, as has been shown above, there already are thousands of licensed and unlicensed people doing many of those other activities, legally or otherwise. It is unlikely there would be major changes in the number of people who would undertake practices not already being done. It is true that patients would have greater latitude in choosing a source of care and that to some extent physicians would have to compete with Registered Practitioners for patients. Assuming that physicians can effectively communicate the benefits of their services it is unlikely that any loss of patients will result.

Overall, it is anticipated that the direct impact of this proposal on the practice and clientele of physicians would be insignificant.

ON OTHER LICENSED HEALTH PROFESSIONS AND OCCUPATIONS

The biggest impact on currently licensed health practitioners would be to remove certain statutory constraints on their scopes of practice. This proposal would not change any of the requirements for licensure of other occupations. and those would continue in force. However, if a licensed practitioner performed some act which now would be considered a violation of Section 2052, it would be illegal only if it fell within one of the prohibitions proposed. Licensed occupations still would not be permitted to diagnose or use radiation (except to the extent which their practice acts currently allow), prescribe or perform surgery. Conversely, the only limitations on their ability to provide treatment would be specific prohibitions within their own practice acts. Licensing- laws for the existing allied health professions provide exemptions from the universal restrictions of Section 2052. By limiting the extent of that section, the need for specific exemptions is eliminated. It would no longer be necessary to amend allied health laws to create new exemptions for new procedures. In addition, the current problems with overlapping scopes of practice between licensed groups would no longer be an issue since treatment would riot be restricted.

In theory, it would not be necessary for many allied health occupations to be licensed. However, in the short run it is unlikely that hospitals or other employers would be willing to hire unlicensed nurses, physical therapists or other occupations since accreditation would continue to require these groups to be licensed. Over time. however, accreditation standards may be modified and appropriate private standards developed to allow health facilities flexibility to use both unlicensed individuals and Registered Health Practitioners as they see fit.

ON UNLICENSED "ORTHODOX" OCCUPATIONS

Within the so called organized healthcare delivery system, the most significant change would be in what unlicensed people would be permitted to do within the system. For example, under current law, many activities commonly done by unlicensed employees in hospitals, clinics and nursing homes are technically illegal. Such groups as hemodialysis technicians, respiratory therapists, operating room technicians, orthopedic technicians and many others are performing diagnostic tests, treatment, and patient care activities which are subsumed under the existing prohibitions of Section 2052. By removing those prohibitions, hospitals and other employers would gain the flexibility to train and utilize technicians efficiently without concern that they may be violating the law. Employers still would be legally responsible for the acts and omissions of their employees, but no longer would be doing so under the cloud of possible illegality.

ON UNLICENSED "UNORTHODOX" OCCUPATIONS

For all the publicity which they generate, the practitioners of health care systems or philosophies which are dramatically different from what is currently considered the norm are relatively few in number. It is estimated that less than 5,000 people would come forward to register if the registration proposal took effect today. Of those, the largest number probably would be practitioners of various philosophies of wellness and self-improvement, including exercise, "holistic" healers, stress management and mental health practitioners. Although each of these groups is capable of causing some sort of patient harm, for the most part the treatments they offer are not particularly threatening in and of themselves. At worst, they may dissuade consumers from seeking traditional forms of treatment for various conditions. However, if one accepts the concepts of freedom of choice and self-determination discussed above, then this becomes a matter of individual judgment, rather than of state mandate.

The biggest change for unlicensed practitioners will be decriminalization of their activities. They would no longer risk. arrest for practicing medicine (i.e. violating Section 2052). The proposal does not give them freedom to practice without regard for patients, other practitioners or the government. In return for the privilege of being permitted to practice openly, they would be compelled to disclose fully and honestly what credentials - if any - they have to practice, what they propose to do to or for patients, and that the state makes no guarantees that they are competent to do anything at all.

For those few who are truly bent on gulling the public, the need to to come out of the shadows, expose their qualifications or lack of them, and be subject to discipline for their activities, may control to some extent the harm which is caused.

It is also likely that over time new forms of practitioners will emerge as a result of the change in the law and that practitioners may be attracted to California from other States. Obviously this will generate competition for patients not only with physicians, but among Registered Health Practitioners themselves.

ON PATIENTS

Everyone shares a sincere concern about the need to protect patients from incompetent, unscrupulous and unqualified health practitioners. However, as we have attempted to show earlier, licensure has not been able to assure that patients are protected. and even without licensure. other quality assurance mechanisms may provide more effective protections than licensure. In the final analysis, the efforts of the state to provide some degree of public protection run headlong into the rights of individuals to freedom of choice and self determination.

The real question, then, is how will this proposal affect patients. The argument has been raised frequently that the poorest, least educated, and (presumably) most gullible, would become the victims of charlatans preying on their (assumed) weakness. That argument is not supported by any evidence that we are able to discover. The most critical determinant of who cares for the poor is money. That money comes from two primary sources: Medicare and Medicaid (Medi-Cal). It is unlikely that either of the governmental insurers would radically alter its standards for payment to include "unorthodox" practitioners who are not licensed, since both programs may legally pay only for services which are accepted medical practice. The same would be true for private insurers. Absent reimbursement. the truly poor would have limited ability to pay for alternative care. although some practitioners are willing to accept low fees or barter for their services.

A frequent argument for opposing alternative health practices is that patients will be harmed by the treatments. There is no doubt that there would be serious incidents brought on by such care, and that there will be occasional deaths. It must be remembered, however. that patient injury and wrongful death occur in the current system and the law has not been able to eliminate it. The state generally learns about illegal practice only at the point when disaster strikes. when someone dies or is badly harmed. If the practitioner is unlicensed, then the state must rely on local civil or criminal courts to prosecute. By registering practitioners. the state would gain limited jurisdiction over their activities, would know who and where they are, and may be able to intervene to prevent recurring harm.

In the short run, the people who choose to be treated by alternative healers probably would not change very much from the present. Patrons of many current practitioners of alternative care often are above average in income, education and intelligence. They tend to be skeptical of tradition and convention, and to be willing to explore ideas and to question what is commonly accepted. These consumers will make their choices whether or not the state agrees with those choices, and will continue to seek and pay for other sources and types of care whether through an 'underground" or openly.

There is another group which may choose to frequent unorthodox practitioners, as is already the case. That group is made up of certain ethnic minorities who elect to use traditional healers within their own cultures. Acupuncture is the most visible example of this. Although it had been practiced in Asian communities In California since the Gold Rush, few non-Asians had ever heard of acupuncture until the Nixon's visited China and observed a demonstration in Peking. A few "western" physicians became interested, and suddenly the state discovered there was an extensive silent network of practitioners who were violating the law by using acupuncture. In 1975, the Legislature legalized the practice, but not before some practitioners were prosecuted for unlicensed practice of medicine.

There are traditional healers in other minority cultures In the state, who will continue to treat their counterparts surreptitiously regardless of whether the state permits them to or not. The proposal describe above would decriminalize their activities. It would not greatly affect who those practitioners treat, nor will it change the nature of their services.

Perhaps the most significant change for patients or consumers would occur gradually after such a proposal was enacted. With the present barriers to alternative practitioners removed, it can be anticipated that the number of such practitioners will increase over the years and that they will advertise and otherwise compete for clients. It may be that the public will be barraged by a bewildering array of. offers to "cure" an assortment of diseases or ailments. It could be argued that consumers will be confused by slick marketing programs and would be induced into dangerous and costly "therapy" which is either unnecessary or ineffective. These are valid concerns and clearly represent the risks involved in allowing for greater individual freedom of choice.

An important change which the proposal would bring about is in the realm of disclosure. Those who currently practice outside the law are under no constraints to provide their patients with any information. In practice, if patients get any information at all it generally consists of inflated claims of training, efficacy of treatments, and descriptions of esoteric knowledge not available to other health professions. Commonly, claims are made that the treatment is used elsewhere in the world with great success, and that it is only the obstinacy of the government or "organized medicine" which prevents Americans from reaping the benefits of the treatment. By registering practitioners. prohibiting false or misleading: advertising, and requiring full and honest disclosure, the state would be able to restrain hyperbole of this sort, and to take action against violators.

Overall, the changes in patient care patterns resulting from this proposal are not likely to be dramatic. Those patients who have always chosen orthodox healers and treatments will continue, for the most part, to do so. Those who, for whatever reason, choose other sources of care, also will continue to do so whether it is legal or not. Many consumers already are questioning the how and why of their treatments and will continue to do so. But most people, if faced with making decisions about their care, will continue to defer to the judgment of those they have always regarded as the experts.

ON HEALTH FACILITIES

As we have mentioned above, licensed health facilities - hospitals, clinics and nursing homes - could find their manpower situations eased somewhat by the Board's proposal. The central change would be in their ability to deploy support staff with greater flexibility. Technology has revolutionized both diagnosis and treatment of health conditions. The next few decades will undoubtedly bring an acceleration of technological change, just as the past three decades have done. Not only do physicians rely on technical experts to operate and maintain the machines, they usually have only superficial knowledge of how they work. Certainly, it would be absurd to maintain that only physicians should be allowed to use these tools, to analyze and interpret the information they generate, and make decisions about that information. Physicians inevitably will have to rely on the knowledge and judgment of unlicensed technicians who are trained and skillful in the new technologies.

Historically, nurses have moved from a role of nursemaid, unquestioningly carrying out doctors' detailed orders, to a role of highly-trained, decision-making professionals. The same kind of role evolution is occurring in other health occupations. More and more routine healthcare is being done, and done well, by non-physicians. To reiterate a point made earlier in this paper, the most complex diagnostic and therapeutic decisions must and should remain the domain of the most highly-trained practitioners -physicians. But equally inevitably, routine care is being done more and more by others. Dr. David Sobel, a participant in the Board's second colloquium at Stanford University, described a clinic which uses a patient algorithm painted on a wail to self-diagnose upper respiratory infections. The clinic has greatly reduced the number of patients seeing its physicians for minor, self-limiting illnesses. Many facilities use nurse practitioners and physicians assistants to screen patients with minor ailments. The majority of those patients are treated - or reassured - without ever seeing a physician.

Whether or not the GMENAC report prediction of a surplus of physicians in the last decade of the century is borne out, technical occupations will continue to evolve into new areas of health care. It is unlikely that doctors will return to taking vital signs, performing EKGs, monitoring dialyzers, removing casts, and all the other functions now being done by licensed and unlicensed support staff. If the current law is not changed, California will continue to have a system which prohibits unlicensed people from doing many support activities, but which looks the other way when they are done, acknowledging that institutional delivery of care would stagger to a halt if the law were vigorously enforced.

This proposal would give hospitals a clearer legal basis for training and utilizing support staff to meet the needs of the institution and the community. As the state discovered when it proposed regulations to create committees on interdisciplinary practice in acute hospitals, changes in occupational regulation do not happen in a vacuum. The Joint Commission on Accreditation of Hospitals opposed the regulations and threatened to withdraw accreditation of California hospitals they were adopted. The regulations were amended to remove the JCAH objections, and they eventually were adopted. Once again, should be recognized that state regulation is just one element in the formal and informal system of controls.

IV. Questions and Answers about the Proposal

1. How will this proposal provide any public protection?

The four most important elements of the proposal are limiting what registrants can do by excluding the procedures named in the revised Section 2052, disclosure, identification of practitioners, and discipline. Practitioners would be specifically prohibited from using surgery, drugs, diagnosis, radiation and invasive instrumentation. The proposal makes full and honest disclosure of training and activities mandatory. At present, alternative practitioners give their patients only the information they choose, which may mean no information at all, or highly inaccurate information. By registering practitioners, the state then would know who is practicing, where they are, and what they are doing. There is little reliable information on these things now. Finally under present law, the state has no jurisdiction over unlicensed practitioners. If an incident of harm occurs, and if the state learns of it, the state must rely on local district or city attorneys to prosecute. Because of crowded court calendars and overworked local law enforcement agencies, only the most blatant cases generally get prosecuted.

2. What about patient harm? If the state registers anyone, regardless of their training or ability, people are going to get hurt; how can a system be seriously proposed which legalizes hurting people?

As we have tried to show, people are practicing surreptitiously with absolutely no controls, and some of their patients are being harmed physically and economically. The state cannot force patients to go to licensed professionals -- to make choices which the state believes are sensible. Following the concept of freedom of choice, this includes freedom to make bad or even dangerous choices. By registering practitioners, the potential for fraud, deceit, gross exaggeration of effectiveness, and pressure on patients to disregard the advice of licensed healers will be greatly reduced. People will continue to be hurt, but their choices of practitioners will be based on more, and more honest information than is now available to them. Further, it should be remembered that patients who choose alternative practitioners are also free to seek other care if they are not satisfied with the result,s of treatment. This self-selection and self-correction process is an important part of the quality control in any health care system.

3. Instead of registering practitioners without evaluating their qualifications, why not license the various occupations and set standards for education and competence?

Individual licensure programs certainly are an option. However, there are dozens perhaps hundreds, of systems philosophies,occupation groups, and individual practitioners, each asserting the uniqueness of its activities. As was pointed out earlier, it would take a massive bureaucracy to create licensure programs establish meaningful standards, develop examinations, and do all the other things associated with licensure. If every new wrinkle in therapy required a new License, or a change in the legal scope of practice for an existing group, the proliferation of regulations and regulators would be endless.

4. But doesn't this proposal create just such bureaucracy?

No. it does not. The proposed Board of Registration would review credentials only to the extent of determining that they are factual. It would not set standards for training, evaluate schools, develop and administer examinations, review transcripts to determine whether program requirements were met, conduct practice audits to establish scopes of practice, or any of the dozens of other activities which individual licensing boards currently do. Keep in mind that this proposal affects a multitude of different practices, yet undertakes only to find out who they are what they are doing, what qualifications they have, and to assure their patients get the same kinds of information. A very small agency, with a staff of five or six will be able to register and oversee several thousand registrants. For comparison, the Psychology Examining Committee regulates about 9,000 people with a staff of six, and this includes all of the activities described above and more. The biggest cost in a program of this sort would be for investigations and legal actions. For this reason, we propose a level of fees which would be adequate to support all program costs including an effective enforcement unit.

5. Doesn't it make more sense to just go after unlicensed practitioners aggressively, close them down, and eliminate the problem?

Given the current enforcement laws, the state cannot act directly against unlicensed practitioners, but must go through local law enforcement agencies. In addition, the illegality of their activities makes practitioners understandably secretive. At present, no one in California has more than a general knowledge of who these practitioners are, how many they are and what they are doing. Regardless, the question begs the issue which is that some citizens choose to be treated by persons who are not licensed, and should have the right to make such choices, even if the state does not consider their choices to be wise. Even a massive enforcement effort could not guarantee that all practitioners would be found, that their activities could be stopped, or that consumers would not seek out others to take their places. In light of the extremely high cost of investigations and court proceedings, such an effort would be prohibitively expensive, with little guarantee of improved public protection.

6. Assuming that a registered practitioner seriously injured a patient, how would the state be able to prosecute if there are no standards?

The proposal includes a number of activities that would constitute unprofessional conduct, and which would be grounds for revoking or suspending registration, as well as fines or imprisonment. If the act which caused the injury violated Section 2052, a fine of up to $5000 and/or a year in jail could be ordered. In addition, the patient would have the option of charging assault and battery in the civil courts. The proposal also includes penalties for false or misleading advertising, failure to make appropriate referrals, and other violations of the law. This includes violations of the laws relating to other licensed health professionals.

APPENDIX II- CATEGORIES OF REGULATION

LICENSURE

Refers to a statute in which a particular occupational group is given an exclusive scope of practice, with penalties prescribed for its violation. Mandatory education and training requirements in an agency-accredited school plus an examination by the Licensing agency. There are two types of licensed practitioners:

A) Independent: Practitioners may practice independently.

B) Subordinate: Practitioners may be supervised by a licensed practitioner authorized to supervise them (e.g., physician's assistants, lab technicians, psychology assistants).

CERTIFICATION

A) Governmental: Governmental certification, frequently referred to as title licensure" or "holding out" laws consist of a nonexclusive scope of practice with penalties limited to fraudulent use of the reserved occupational title (e.g., registered nurse). Education and training standards are mandatory if a person wishes to be certified but not for practice by an uncertified practitioner.

B) Private: Private certification means that a person has successfully fulfilled privately defined education standards for a private occupational association, school or other private institution. The certification has no legal status except that accorded to it by other provisions of law.

C) Private/Governmental or by Reference: this is another type of governmental certification in which the government simply adopts or accepts the standards of a private occupational association "by reference." Thus the association's standards acquire the force of law. The scope of practice may or may not be specifically delineated but practice may be restricted by statutory or regulatory requirements which make reference to the occupation. For example, requirements for facilities' licensure (hospitals, labs, clinics, SNF's, etc.) may require the presence of personnel who have met the requirements of a particular association. Penalties are limited to those upon the facility for violation of the facilities' license.

REGISTRATION: Registration refers to an administrative record - Keeping system which requires persons who perform certain activities or who hold themselves out as members of a given occupational group, to register with the state. There are no education and training requirements, no standards of practice. The scope of practice is exclusive only to the extent that registration is required, i.e., an unregistered person usually may nor practice.

PROPOSED LEGISLATION

Section 1.

It is the intention of the Legislature to recognize that the preservation of health and the treatment of illness, injury and disability are highly personal activities which should be subject to as little regulatory interference as is consistent with preservation of public health, safety and welfare. It is the further intention of the Legislature to enact a system which permits the citizens of this state to have reasonable access to health care practitioners of their choice, without prejudice; and further, to recognize that numerous alternatives exist to traditional sources and modes of treatment; that citizens of this state have an inherent right to choose such alternatives, to assume responsibility for the consequences of such choices, and to have access to practitioners of such alternatives. Therefore, the Legislature does enact the following amendments to the Business and Professions Code to achieve these objectives.

Section 2.

2052. Any person who practices or attempts to practice or who advertises or holds himself or herself out as practicing any system or mode of treating the sick or afflicted in this state or who diagnoses, treats, operates for or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury or other physical or mental condition of any person diagnoses any disease. injury. or disfigurement of; performs surgery or otherwise severs or penetrates the tissues or prescribes any drug which requires a prescription under Federal or State law or: performs instrumentation beyond the vagina mouth or anus or: or uses or orders the use of ionizing radiation upon any person: without having at the time of so doing a valid, unrevoked, or unsuspended certificate as provided in this chapter, or without being authorized to perform such act pursuant to a certificate obtained in accordance with some other provision of law, is guilty of a misdemeanor.

Section 3.

2053. Any person who willfully, under circumstances or conditions which cause or create risk of great bodily harm, serious physical or mental illness, or death, practices or attempts to practice, or advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person, without having at the time of so doing a valid, unrevoked, or suspend~d certificate as provided in this chapter, or without being authorized to perform such act pursuant to a certificate obtained in accordance with some other provision of law, or who. while having such certificate under another provision of law performs any act or acts specified in Section 2052 above, is guilty of a misdemeanor and is punishable by imprisonment in the county jail for not exceeding one year or in the state prison, or subject to a fine not exceeding S50O0 or a combination of fine and imprisonment.

Article I. Registration Required

1. Registration Required

Notwithstanding any other provision of law, any person who holds himself or herself out as practicing any system or mode of treating the sick or afflicted, or any physical or mental condition, in this state and who is not otherwise licensed, registered or certified under sane other provision of law shall register with the board and pay a fee as specified, prior to undertaking such a practice.

2. Religious and Psychic Exemption

Any person who treats the sick or afflicted by means of prayer, laying on of hands, positive thinking, religious, psychic or other non contact modalities is exempt from the provisions of this act.

3. Unlawful Representation as a Registrant

Any person who in any sign, business card, letterhead, advertisement, or other public communication, uses the words "registered health practitioner" or "registered practitioner" the initials "RHP", or any other terms or letters indicating or implying that he or she is a registrant under this chapter, or is entitled to practice hereunder, without having at the time of so doing a valid, unrevoked and unsuspended certificate of registration is guilty of a misdemeanor.

4. Definitions

For the purposes of this chapter:

1. "Board" means the Health Practitioner Registration Board of the Department of Consumer Affairs.

2. "Registered Health Practitioner" or "practitioner" means a person registered with the board under this chapter.

3. "Patient Disclosure/Informed Choice" means a statement provided to each patient of a registered health practitioner as required in Article. 3 of this chapter.

4. "Health Practitioner Disclosure Statement" means a statement attached to an application for registration as required in Article 3 of this chapter.

5. "Code" means the Business and Professions Code unless otherwise specified.

6. "Fund" means the Health Practitioner Registration Fund.

7. "Patient" or "client" means a person who is receiving, or considering receiving treatment or other service(s) from a practitioner.

8. "Treatment", "service", "modality", "activity", "therapy" and other similar terms shall mean an interaction between a practitioner and a patient which has its goal a change in the physical or mental condition or state of the patient. Communications with respect to the type of services or other activities offered or recommended by a practitioner shall, not be considered treatment.

5. Use of Titles or Initials

Only a registrant under this chapter shall hold himself or herself out as a registered health practitioner or use any other term indicating or implying that he or she is a registrant, but no other title, term, or initials may be used in connection with such registration. A registrant may use informational terms or descriptions in advertising or other public communication which identify a mode or system of practice, or philosophy of treatment, but such terms or descriptions shall be clearly separated from the registrant's name and :title or initials.

6. Use of Academic Titles

Notwithstanding the provisions of this section, a registrant may use a title, initials, or other prefix or suffix indicating possession of a specific earned academic degree granted by an institution approved by the Superintendent of Public Instruction to grant such degree, or an institution accredited by an appropriate regional or national accrediting body under subdivisions (a) or (b) of Section 94310 of the Education Code, provided that in conjunction with the use of such title, initials, prefix or suffix, the registrant clearly identifies the title and nature of the degree. Nothing in this chapter shall be construed as permitting a registrant to use the title "doctor", "medical doctor", "physician", "surgeon", or similar title, or the initials "M.D.", "D.O.", D.N.", "N.D., "Dr.", "D.C.", or any other title, abbreviation or initials implying he or she is a licensed physician, osteopath, naturopath, chiropractor, homeopath or other licensed health practitioner, without having at the time of so doing a current, unrevoked and unsuspended license in this state.

1. Board of Health Practitioner Registration

There is hereby created in the Department of Consumer Affairs, the Board of Health Practitioner Registration, which shall administer the provisions of this chapter.

2. Appointment

The board shall consist of 11 members, appointed by the governor, who shall be public members, and shall not be registrants of the board or licensees of any healing arts board under this code or any initiative act.

3. Terms

Each member of the board shall hold office for a term of four years, and shall serve until the appointment and qualification of his or her successor or until one year shall have elapsed since the expiration of the term for which he or she was appointed, whichever occurs first. No member may serve for more than two consecutive terms. Four of the initial appointees shall serve a term of two years, four shall serve for three years, and three shall serve for four years. Their terms shall be determined by lot at the first meeting of the board.

4. Members Qualifications

The members shall be appointed from persons having all of the following qualifications:

a) Be a citizen of the United States, and a resident of this state for at least five years immediately prior to appointment.

b) Be at least 18 years of age.

c) Shall not be an officer or faculty member of any college, school or institution engaged in education or training of health occupations or activities.

1. Board of Health Practitioner Registration

There is hereby created in the Department of Consumer Affairs, the Board of Health Practitioner Registration, which shall administer the provisions of this chapter.

2. Appointment

The board shall consist of 11 members, appointed by the governor, who shall be public members, and shall not be registrants of the board or licensees of any healing arts board under this code or any initiative act.

3. Terms

Each member of the board shall hold office for a term of four years, and shall serve until the appointment and qualification of his or her successor or until one year shall have elapsed since the expiration of the term for which he or she was appointed, whichever occurs first. No member may serve for more than two consecutive terms. Four of the initial appointees shall serve a term of two years, four shall serve for three years, and three shall serve for four years. Their terms shall be determined by lot at the first meeting of the board.

4. Members Qualifications

The members shall be appointed from persons having all of the following qualifications:

a) Be a citizen of the United States, and a resident of this state for at least five years immediately prior to appointment.

b) Be at least 18 years of age.

c) Shall not be an officer or faculty member of any college, school or institution engaged in education or training of health occupations or activities.

5. Officer.

The board shall elect annually a president and vice president from among its members.

6. Compensation

Each member of the board shall receive a per diem and expenses as provided in Section 103 of the Code.

7. Personnel

Except as provided by Section 159.5, the board may employ such personnel as necessary to carry out the provisions of this chapter. The board may employ, exempt from the provisions of the Civil Service Act, an executive officer. The board may contract for the services of special consultants to advise it on matters which come before the board, but shall not use such consultants to circumvent the Civil Service Act.

8. Contributions

The board may accept contributions to effectuate the purposes of this chapter.

9. Rulemaking Authority

The board shall adopt such regulations as may be necessary to carry out the provisions of this chapter.

10. Rules of ethical Conduct

The board may adopt regulations establishing standards of ethical conduct relating to practice by registrants, in addition to those contained in Article 4 of this chapter. The board may implement a program of consumer and professional education in responsibilities to clients.

11. Meetings

The board shall hold at least one regular meeting each year. Additional meetings may be held upon call of the president or at the written request of any two members of the board.

The board may convene from time to time until its business is concluded. Special meetings may be held at such time and place as the board may designate. The board shall keep an accurate record of its meetings and proceedings.

12. Committee Meetings

The president of the board or the chairperson of any committee may call meetings of any duly appointed and created committee at a specified time and place.

13. Quorum

A majority of the appointed members of the board shall at all tines constitute a quorum.

Article 3. Requirements for Registration

1. Requirements for Registration

The board shall issue a certificate of registration pursuant to this chapter to any person who meets the following requirements, and is not otherwise exempt from registration:

a) Is at least 18 years of age.

b) Makes application for registration on a form provided by the board, and attaches such documents as may be required in regulations adopted by the board.

c) Completes a health practitioner disclosure statement on a form provided by the board.

d) Pays all applicable fees.

e) Is not subject to denial of registration under Division 1.5.

2. Health Practitioner Disclosure Statement

The application shall include the following information and other documentation as specified:

a) The applicant's full name and any other name(s) by which (s)he is or has been known.

b) Business and home addresses and phone numbers.

c) A description of the philosophy and theory of the system(s) or modalities of treatment which the applicant proposes to utilize.

d) A description of the procedures or modalities of treatment the applicant proposes to use or offer.

e) A listing of any relevant formal. education or training, including degrees earned, institutions attended including the dates of attendance at each such institution. An official transcript shall be sent directly to the board by the registrar or other appropriate officer of each such institution.

f) A listing of any additional experience, informal education, on&emdash; the&emdash;job training, membership in professional association(s) or other qualifications which would, in the opinion f the applicant, further qualify him or her for practicing the activities listed under (c) and (d) above. If an applicant lists any seminars or other relevant training, (s)he shall provide documentation satisfactory to the board of the content of the training and of attendance.

g) The board may require additional documentation to support any claims or statements made in the application or disclosure

An updated copy of the health practitioner disclosure form shall be filed with the board during the month of June of each year, and shall be available for public inspection. Any change of address, mode of practice, education or training, or other information required on the health practitioner disclosure form shall be reported to the board within ten calendar days of such change. Failure to file the annual updated copy of the form, or to notify the board of changes as required shall be grounds for revocation of registration.

The board shall maintain a listing of all practitioners registered under this chapter, and shall provide copies of that listing on request, at its cost. The board may publish a directory of registrants.

3. Patient Disclosure/Informed Choice Statement

Prior to providing any treatment or service, a registered health practitioner shall give each patient a copy of a Patient Disclosure/informed Choice Statement, which shall include a summary of the information provided in the Health Practitioner Disclosure Statement, and any other information

The board shall adopt a standardized form for the Patient Disclosure unformed Choice Statement, and standards for its content and its use.

At a minimum, the statement shall include the information required in the Health Practitioner Disclosure Statement, and the following statements, which shall be set off from the remainder of the form and printed in boldface type which shall be no smaller than 12 point (1/8th inch in height). If the registrant serves a population with a significant portion of clients whose primary language is other than English, the entire statement shall be made available to such clients in such ocher language(s).

NOTICE

THE STATE OF CALIFORNIA DOES NOT EVALUATE THE EDUCATION, TRAINING, EXPERIENCE OF COMPETENCE OF REGISTERED HEALTH PRACTITIONERS. REGISTRATION IS NOT AN ENDORSEMENT OR GUARANTEE OF THE COMPETENCE OF THIS PRACTITIONER. THE STATE OF CALIFORNIA DOES NOT TEST OR CERTIFY THE REGISTRANT'S KNOWLEDGE, OR THE EFFECTIVENESS OR SAFETY OF THE TECHNIQUES USED BY THIS PRACTITIONER. AS A CONSUMER YOU MUST EXERCISE YOUR OWN JUDGMENT TO DETERMINE IF THIS PRACTITIONER IS ABLE TO PROVIDE YOU WITH THE SERVICES WHICH YOU DESIRE. REGISTERED HEALTH PRACTITIONERS MAY NOT DIAGNOSE DISEASE, INJURY OR DISFIGUREMENT. DIAGNOSIS MAY BE PERFORMED ONLY BY LICENSED HEALTH PROFESSIONALS. IF YOU ARE UNSURE OF THE NATURE OF YOUR CONDITION, YOU ARE ENCOURAGED TO CONSULT AN APPROPRIATE LICENSED HEALTH PROFESSIONAL SUCH AS A PHYSICIAN.

THE REGISTERED HEALTH PRACTITIONER WHO PROVIDED YOU WITH THIS FORM IS REQUIRED TO DO SO BY LAW, AND MAY NOT COMMENCE ANY FORM OF TREATMENT, COUNSELING OR OTHER CARE WITHOUT YOUR CONSENT. YOUR SIGNATURE ON THIS FORM SIGNIFIES THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION HEREON. YOU HAVE THE RIGHT TO HAVE ANY QUESTIONS YOU MAY HAVE ABOUT THIS FORM, OR ANY TREATMENT OR SERVICE OFFERED, ANSWERED TO YOUR SATISFACTION PRIOR TO SIGNING THE FORM OR CONSENTING TO ANY TREATMENT OR OTHER SERVICE. SIGNING THIS FORM IN NO WAY OBLIGATES YOU TO AGREE TO ANY TREATMENT OR OTHER SERVICE OFFERED BY THE REGISTERED HEALTH PRACTITIONER.

4. Additional Disclosure Requirements

In addition to providing each patient with a copy of the statement, a copy of the statement shall be prominently posted in each practice location, in the public waiting area and in each treatment or examination room. Any individual who employs another registered practitioner or aide shall be responsible for compliance with the disclosure requirements of this article for each such employee.

5. Consent to Treatment

Prior to commencing any treatment or other service, a registrant shall secure the consent of the patient for the specific treatment or other service. The form used to secure consent to treatment shall be a standardized form adopted by the board, and shall include at minimum the following information:

1. Date

2. Names of practitioner and patient

3. Location where treatment or other service will be performed

4. A description of the proposed treatment, including the basis for selection of that treatment, and a description of the objectives of the treatment.

5. An estimate of the number of treatments or services which the practitioner reasonably believes will be necessary, to achieve the expected outcome, and the proposed frequency of such treatment or service.

6. A description of any equipment, preparations, or other modalities which will be used during treatment (such as mineral baths, biofeedback monitors, herbs, etc.) and the purposes of such equipment, preparations or modalities.

7. A medical history form to be completed by the patient. The board shall specify in regulation the content of the medical history form.

8. The following statement shall be printed in boldface type not be less than 12 point directly above the patient's signature:

BY SIGNING THIS FORM, I ________________________(PATIENT'S NAME) GIVE MY CONSENT TO THE TREATMENT(S) DESCRIBED HEREIN, TO BE RENDERED BY _________

_________(PRACTITIONER'S NAME). I UNDERSTAND THAT I MAY DISCONTINUE SUCH TREATMENT AT ANY TIME. IF I HAVE BEEN DIAGNOSED BY A LICENSED HEALTH PROFESSIONAL AS HAVING ANY DISEASE, INJURY OR OTHER PHYSICAL OR MENTAL CONDITION, I UNDERSTAND THAT THE STATE OF CALIFORNIA SUGGESTS THAT I SHOULD INFORM THE PERSON WHO MADE THE DIAGNOSIS, ABOUT THE TREATMENT(S) I WILL BE RECEIVING, AND WHETHER OR NOT I INTEND TO DISCONTINUE ANY TREATMENT OR THERAPY WHICH HAS BEEN PREVIOUSLY ORDERED, PRESCRIBED OR RECOMMENDED BY A LICENSED HEALTH PROFESSIONAL. I UNDERSTAND THAT BY DISCONTINUING ANY SUCH TREATMENT OR THERAPY, I ASSUME RESPONSIBILITY FOR ANY NEGATIVE OUTCOME RESULTING FROM DISCONTINUING THAT TREATMENT OR THERAPY.

9. Complaint Notice Requirement

To assist consumers in receiving appropriate services, all registrants shall be required to post or disclose in a conspicuous manner or location, a notice which reads as follows:

NOTICE: The Department of Consumer Affairs receives questions and complaints regarding the practice of registrants. If you have any questions or complaints, you may contact this department by calling (insert appropriate phone number), or by writing to the following address: (insert appropriate address). The notice required by the section shall not be smaller than 84 inches by 11 inches and shall be legibly printed with lettering no smaller than 1/2 inch in length, except the lettering of the word "NOTICE" shall not be smaller than 1 inch in length For the purposes of this chapter, it shall be unprofessional]. conduct to do any of the following:

1. Violate, any provision of this chapter.

2. Fail to comply with the requirements of Article 3 regarding disclosure,including:

a. Misrepresentation of credentials, education, training, licensure, degrees or other information required to be provided;

b. Failure to post notices as required, or to provide patient disclosure;

c. Practice beyond the scope of activities listed in the application, disclosure statement, or any subsequent disclosure statements submitted to the board;

d. Failure to notify the board of changes in information required in the application or patient disclosure statement within the time specified.

3. Advertise in a manner which is false or misleading, including unsubstantiated claims about the efficacy of any treatment, or claims of cures, including testimonials.

4. Advising or attempting to persuade patients to discontinue treatments or drug regimens, prescribed, ordered or recommended by a licensed health professional., or dissuading or attempting to dissuade patients from consulting other health professionals for any reason; or making statements or claims to patients regarding the effectiveness or worth of treatments offered or recommended by a licensed health professional.

5. Fraud or dishonesty.

6. Patient abuse, including harassment.

7. Failure to refer obvious medical. conditions for appropriate treatment.

8. Violation or attempted violation of this chapter, the medical practices act, any other healing arts law, or initiative act, or any regulations duly adopted by this board or any other healing arts board.

Section xxx. Health Practitioners Registration Fund

There is established in the State Treasury the Health practitioners Registration Fund. All fees, fines and collections pursuant to this chapter shall be reported to the Controller on or before the 10th day of each month for the month preceding, and shall be paid by the board into such fund. All money in the fund shall be continuously appropriated to the board for the purposes of this chapter.

Section xxx. Fees

The amount of fees prescribed by this chapter shall be fixed by regulation by the board pursuant to the following schedule:

a)The fee for application for registration as a health practitioner shall be an amount not less than one hundred fifty dollars ($150) nor more than three hundred dollars ($300).

b) The fee for initial registration shall be an amount not less than one hundred fifty dollars ($150) nor more than three hundred dollars ($300) except that if an initial registration shall expire less than one year after the date of issuance, the initial registration fee shall be 75 of the initial registration fee.

c) The fee for renewal of a registration shall be the initial registration fee then in effect for a full two&emdash;year registration.

d)The delinquent renewal penalty fee shall be thirty dollars ($30).

Section xxx. Violations Constitute a Misdemeanor

Unless it is otherwise expressly provided, any person, whether registered under this chapter or not, who violates any provision of this article is guilty of a misdemeanor.

Section xxx. Penalty for Violations

Except as otherwise provided by law, any person found guilty of a misdemeanor for a violation in this chapter shall be punished by a fine of not less than one hundred dollars ($100) nor more than six hundred dollars ($600) or by imprisonment for a term of not less than 60 days nor more than 180 days, or by both such find and imprisonment.

Section xxx. Conviction of a Crime

A plea or verdict of guilty or a conviction following a plea of nolo contenderi made to a charge of a felony or of any offense which is substantially related to the qualifications, functions or duties of a registrant or applicant for registration under this chapter is deemed to be a conviction within the meaning of this chapter. The board may order the certificate suspended or revoked, or shall decline to issue a certificate when the time for appeal has elapsed, or the judgment of conviction has been affirmed on appeal or 'when an order granting probation is made suspending the imposition of sentence, irrespective of a subsequent order under the provisions of Section 1203.4 of the Penal Code allowing such person to withdraw his plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information or indictment.

Section xxx. Denial of Application

The board may order the denial of an application for, or the issuance subject to terms and conditions of, or the suspension or revocation of, or the imposition of probationary conditions upon a registrant under this chapter after a hearing as required in Section xxx for unprofessional conduct as specified in Section xxx or for any other violation of this chapter, a violation of the State Medical Practice Act, of a violation of the regulations adopted pursuant to this chapter by the board.

Section XXX. Injunctions

Whenever any person has engaged in any act or practice which constitutes an offense against this chapter or a clear and present danger to the public health or safety, the superior court of any county, on application of the board, may issue an injunction or other appropriate order restraining such conduct. Proceedings under this section shall, be governed by Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure provided that no undertaking shall, be required in any action commenced by the board. The board may commence action in the superior court under the provisions of this section.

Section xxx. Proceedings

Any proceedings involving the denial, suspension or revocation of a certificate under this chapter shall be conducted in accordance with the Administrative Procedures Act.

ŠKunz and Kunz 2004
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