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7 Licensure and Other Mechanisms for Regulating Allied Health Personnel THE CONGRESSIONAL CHARGE to this committee directed it to investi- gate current practices under which each type of allied health personnel obtains licenses, credentials, and accreditation" (Appendix A, Section 223EbjE3j). The committee has taken a rather broad view of this charge, interpreting it to encompass the whole array of mechanisms meant to ensure that allied health personnel are properly trained and competent to practice. These mechanisms, which include licensure and other forms of governmental regulation, voluntary certification, and standards imposed by health care providers and payers, are central to this study in that they interact with and influence virtually all of the other study issues. For example, the scope of practice for a field that is defined under state licensing statutes and regulations affects the demand for allied health per- sonnel by constraining how they may be used by employers. Certification, if it is accepted as a valid distinction by employers or if it is required by accrediting bodies such as the Joint Commission on Accreditation of Health- care Organizations, also affects employers' decisions to employ allied health personnel; certified and noncertified members of the same allied health field are then treated as separate labor pools. Regulatory mechanisms also influence supply by defining who may enter and remain in certain allied health fields. A great deal is at stake here. Health care payers rely on licensure and other credentialing mechanisms to assist them in defining eligibility for coverage and reimbursement for allied health services. The various allied health occupations look to these mechanisms to give them identity and legitimacy by defining the nature and length of training, requirements for 235

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236 ALLIED HEALTH SERVICES entry into the field, and the power to control certain health care practices. In a time of great ferment in health care, these control mechanisms take on even greater significance. The proliferation of health care occupations, changing models of health care delivery, and new reimbursement methods, alone with cost-~ontro1 efforts he incl~strv and government, place stresses in. in, . ~ ,, ~ ~ ~ ~ ~ ~ ~ ~ on these controls. To carry out this part of the congressional charge, the committee held discussions with officials of government agencies and private organizations responsible for the various control mechanisms. It also held a public hearing at which 26 allied health associations and 4 experts presented testimony; two of the experts prepared papers for the committee on state regulation of health occupations. In addition, the committee reviewed the research literature on occupational regulation. METHODS OF CONTROL State Regulation Society applies many quality control methods to health care personnel, including allied health personnel. The states bear the greater responsibility in this control system. Through occupational licensure and other forms of regulation, states exercise their authority to protect the health, safety, and welfare of their citizens. The earliest attempts to regulate health occupations in this country were in colonial Virginia (1639), Massachusetts (1649), and New York (1665), when medical practice acts were enacted. By the begin- ning of the twentieth century, the Supreme Court had validated this use of the states' police powers, and most states had licensed lawyers, dentists, pharmacists, physicians, and teachers. Between 1900 and 1919, most states also licensed nurses, optometrists, osteopaths, podiatrists, and veterinarians (Carpenter, 1987~. Before 1960, this list had expanded to include dental hygienists, practical nurses, and physical therapists. Since 1960, only three health occupations have come to be universally licensed: psychology, nurs- ing home administration, and emergency medical technology. The latter two were licensed as the result of federal legislation. Table 7-1 shows the licensure status of the 10 allied health fields on which this study concentrates as of June 1987. Among these fields, physical therapists and dental hygienists are licensed in every state. Emergency medical technicians must be certified by some agency in every state. At the other extreme is medical record administration, for which no state requires licensure; this field relies instead on certification (registration) by the Amer- ican Medical Records Association. All the other fields are licensed in some states: for example, respiratory therapists are licensed in 7 states, audiol- ogists and speech-language pathologists in 37.

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REGULATING ALLIED HEALTH PERSONNEL TABLE 7-1 Licensure Status of Selected Allied Health Fields Field Licensure Status 237 Clinical laboratory Medical technologists are licensed in 5 states and New York technology City. Technicians are not licensed in any state. Dental hygiene Dental hygienists are licensed in all 50 states and the District of Columbia. Dental assistants are not licensed in any state. Dietetics Dieticians are licensed in 14 states, the District of Columbia, and Puerto Rico. Emergency medical services Certified in all 50 states. Medical record Neither medical record administrators nor medical record services technicians are licensed in any state. Occupational therapy Occupational therapists are licensed in 34 states, the District of Columbia, and Puerto Rico. Occupational therapy assistants are not regulated in any state. Physical therapy Physical therapists are licensed in all 50 states. Physical therapy assistants are licensed in 18 states. Radiology Radiographers are licensed in 17 states and Puerto Rico. Radiation therapy technologists are licensed in 15 states and P~erto Rico. Nuclear medicine technologists are licensed in 10 states and Puerto Rico. Respiratory therapy Respiratory therapists are licensed in 7 states. Speech-language Speech-language pathologists and audiologists are licensed in pathology/audiology 36 states and Puerto Rico. SOURCE: Information from professional associations, updated to tune 1987. Licensure is the most restrictive form of state regulation. Carpenter (1987) defines licensure as "a process by which a governmental agency restricts entry into an occupation by defining a set of functions and activities constituting a 'scope of practice,' grants permission to engage in that prac- tice only to persons meeting predetermined qualifications, and establishes structures and procedures for screening applicants and granting licenses to practice." These and other definitions share certain common elements, including: licensure is intended to protect the public; licensure is exclusionary; licensure prescribes the characteristics and qualifications of persons who may be licensed; licensure defines a scope of practice for licensees (and therefore li- censure laws are often referred to as "practice acts"~; and licensure prohibits nonlicensed persons from engaging in the defined scope of practice. Although the standard definitions focus on initial entry, licensure also addresses standards of practice and ethical and business behavior (what it

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238 ALLIED HEALTH SERVICES takes to keep a license) and causes for disciplinary action (what it takes to lose a license). By long tradition, licensure has been, for all practical purposes, a form of state-sponsored self-regulation because it has been carried out by boards composed of members of the regulated occupation empowered to act with a high degree of autonomy. As Shimberg (1984) noted in recounting the history of state licensure: These boards had broad powers to implement the law by promulgating rules and regulations governing practice standards and professional conduct; establishing minimum education, training, and experience qualifications; examining candidates as to their fitness to practice; investigating complaints against practitioners; and taking appropriate disciplinary action, including suspension or revocation of a practitioner's license where appropriate. Recent reforms have broadened the membership of licensure boards to include representatives of the public who may or may not have voting privileges. Yet, on the whole, the licensed occupations still are largely self- regulated. This point is elaborated later in this chapter. However, licensure carries with it a whole array of regulations and administrative procedures for implementing the state statutes. States can and do use a number of modes of occupational regulation other than licensure (Table 7-2~. Among the 10 allied health fields covered in this report, title protection through registration or certification by the state is the most frequently used form of regulation other than licensure. This regulatory mechanism is also applied in other fields such as accoun- tancy, in which anyone can practice but only those who have met state standards can use the title "certified public accountant." In one form or another, about 800 occupations are regulated by the states, including ar- chitects, real estate brokers, barbers and cosmetologists, electricians, and engineers. Besides occupational regulation, states also oversee allied health person- nel through the regulation of institutions and settings in which they work. Requirements for the licensure of hospitals and nursing homes include personnel standards. In addition, states have other laws and regulations of broad applicability in place, such as those that govern business practices and provide consumer protection, that may be used against incompetent or unscrupulous allied health personnel. The states also define qualifica- tions for civil service positions held by these personnel. Consumers may use the tort system in any state to file civil suits to seek compensation for malpractice by allied health personnel. Presumably, this mechanism carries some deterrent effect; in the context of quality assur- ance, however, it must be viewed as a last resort.

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REGULATING ALLIED HEALTH PERSONNEL TABLE 7-2 Modes of Occupational Regulation 1. PRACTICE STANDARDS Without special enforcement Through the adoption of statutes and rules, this mode can establish restrictions on the practice of an occupation with civil or criminal penalties enforceable through the courts. This type of regulation requires no inspections, registration, or special enforcement staff. Rather, it relies on action by the harmed parties or by a consumer affairs office. With special end orcement Through statutes, or rules, or both, this mode can establish restrictions on the practice of an occupation in addition to establishing inspections, enforcement mechanisms, and penalties. However, this mode does not require registration, certification, or any assessment of the practitioner's credentials or competency. 239 2. REGISTRATION Without standards Through regulation, a state agency can require persons in an occupation to register and supply certain information without requiring any standards, testing, or enforcement. With standards It is also possible to have a registration requirement in combination with minimum practice standards that are set by a designated agency. Although registration would not be exclusionary, it would subject registrants to minimum standards and thereby provide some protection to the public. 3. STATUTORY CERTIFICATION With state standards and state enforcement Through regulation, occupational members can be required to meet certain state standards; only those who meet these predetermined qualifications may legally use the designated title of the occupation. This mode entails standards, testing, codes of practice, possible inspections, and enforcement. With private standards and assessment and state enforcement Through regulation, an agency of the state may require members of an occupational group to meet certain standards established by a private testing or assessment center or organization (reviewed by the state), with the state handling the certification and any enforcement required. Legally, the state is responsible for the standards set and for monitoring the process. 4. STAT~ToRY CERT~F~cAT~o~ AND PRAcT~cE STA~DARDs A state may establish, by rule, certification for an occupation and also request the legislature to pass a law that would establish practice standards for that same occupation. This combination would establish a system of title control for those meeting certain required standards of competency, as well as establishing standards of practice for anyone who practices the occupation. 5. REGULATION THROUGH SuPERv~s~oN BY AN ALREADY L~cENsED PRAcT~T~oNER Certification with standards Through statutes and rules, an occupation can be certified and required to work under the supervision of an already licensed occupation; standards for practice can also be established. Continued

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240 TABLE 7-2 Continued ALLIED HEALTH SERVICES Through standards of practice but without certification It is also possible to regulate by providing that the occupation be performed under the supervision of a licensed professional with certain standards set forth but without -requiring that the individual be certified. 6. L~cENsuRE Licensure is the most restrictive form of occupational regulation, providing for both title control and an exclusive area of practice. It requires standards of practice, education, knowledge or minimum competency, and inspection and enforcement with civil and criminal penalties. SOURCE: Goldman and Helms (1983). Criticisms of State Regulation Occupational regulation has been in ferment for at least 20 years. Crit- icisms have come from a number of quarters, and these criticisms have given rise to recommendations for reform. Some changes have occurred as a consequence. In the 1960s the source of concern was access to health care. With an apparent shortage of physicians, there was concern that restrictive licensing laws were hampering the effective deployment and utilization of physicians' assistants and other physician extenders. This issue was addressed by the National Advisory Commission on Health Manpower in its 1967 report. At the direction of Congress in the Health Training Improvement Act of 1970, the U.S. Department of Health, Education, and Welfare's Office of the Assistant Secretary for Health and Scientific Affairs investigated prob- lems in health care personnel licensure and certification. The department's 1971 Report on Licensure and Related Health Personnel Credentialing contained far-reaching recommendations, including a recommendation to the states for "a two-year moratorium on the enactment of legislation that would establish new categories of health personnel with statutorily-defined scopes of functions." The moratorium was to allow time for further con- sideration of the tasks and functions of new health care occupations. Questions about the wisdom of occupational licensure still remain, al- though the circumstances today are different. The perceived shortage of doctors and dentists has changed to a perceived surplus, and the number of newly emerging health care occupations is increasing. Since the early 1970s the issue of rising health care costs has taken on greater and greater importance. In the context of cost containment, the fact that more and more health occupations have been seeking statutorily protected scopes of practice is worrisome. This proliferation is seen as contributing to ineffi- ciencies in the health care industry, especially in view of the rapidity of technological change.

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REGULATING ALLIED HEALTH PERSONNEL 241 Allied health personnel are affected by this tension. Many of the allied health fields are new, and, according to the example offered by older, well- established fields such as medicine, nursing, and dentistry, state licensure is crucial to their achieving recognition as professions. Licensure, it is be- lieved, gives legal validation to the field's unique status. It provides a way of excluding unqualified practitioners from providing services; it gives official recognition to the field's scope of practice; and it offers easily ver- ified credentials that can be used by employers and health care payers (McCready, 19821. Licensure is also considered to be necessary to avoid being subject to prosecution. For example, physicians would be vulnerable to prosecution for practicing medicine without a license, since many medical practice acts are so broad that physicians are granted virtually unlimited ~ . scopes ot practice. Above all, state regulation is viewed as a means of improving the quality of health care by restricting entry into health care occupations to persons who have proper credentials and by disciplining persons who do not meet standards of professional behavior. Much of the criticism leveled at reg- ulation is based on the lack of evidence on this point. Criticisms Or Structure and Process The traditional regulatory structures and processes, which were devel- oped in the last century, are criticized as anachronistic and inconsistent with the public policy objective of protection of the public. By long tradition, the regulation of a health occupation, given a practice statute, is the responsibility of a board. The composition of the board is usually defined in the statute. One of the strongest criticisms of the reg- ulatory structure is that these boards are not sufficiently accountable to the larger public. Until recently, they were composed entirely of members of the regulated occupation, drawn from the membership of their related associations. In many states, they generated their own revenues by charging fees to candidates and licensees; they had their own staffs; they were often located in the home of the board's secretary; and they had considerable rule-making authority with little or no oversight. Their proceedings were closed to the public, as were their records. By statute, the regulatory boards are charged with setting entry require- ments, practice standards, and codes of conduct, and with disciplining licensees who fail to meet those standards and codes. The performance of these functions has also been subject to criticism. Eligibility standards are defined in terms of education and, in some cases, experience. Boards also require entrants to pass an examination that, in some cases, is devised by the board. In other cases, the board relies on a

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242 ALLIED HEALTH SERVICES national examination or commissions a testing organization to develop a state exam. Criticisms that have been leveled at entry requirements are that they are inflexible, offering only one path to entry; that education and experience requirements are unrelated to the demands of practice; that educational requirements rest heavily on accreditation, which in turn is controlled by the professional associations; that examinations are not valid reflections of "real-world" practice requirements; and that the common practice of "grandfathering" current practitioners when licensing a new occupation is inconsistent with the goals of protecting the public health and welfare. "Standards of practice" are defined in terms of behaviors that are subject to disciplinary action, including fraud and deception in obtaining the li- cense; conviction of a felony; engaging in unacceptable patient care through deliberate or negligent acts; knowing violation of the practice act; contin- uing to practice although unfit; and lewd or immoral conduct in the delivery of services. "Codes of conduct" most commonly prohibit business practices that are considered unacceptable professional behavior. Traditionally, these have included advertising; practice in chain or department stores, shopping centers, or other commercial environments; and engaging in competitive bidding. Disciplinary procedures are usually defined in the statute. In some states and for some occupations, revocation of a license is the only sanction provided. In others, the statute defines an array of sanctions of varying degree, including license suspension, censure, and reprimand. Boards have been criticized for the way they carry out their disciplinary responsibilities: they only investigate complaints of incompetence or im- propriety, rather than performing any independent monitoring. Impro- priety (i.e., violation of the code of ethics) is more frequently the basis for disciplinary action than is incompetence. The number of disciplinary ac- tions is extremely low in comparison with estimates of the incidence of incompetent practice. The public is not informed of disciplinary actions against licensees. A partial explanation for the historical lack of disciplinary vigor is the inadequacy of the resources available to the task of investigating and "prosecuting" complaints. Without sufficient staff and budget, the regulatory process is more bark than bite. "Turf'' monitoring and turf protection occupy a significant portion of the energies of a state's regulatory apparatus. The various occupations battle among themselves over which parts of health care and which parts of the patient fall under their jurisdiction. These battles are fought by establishing practice acts and by implementing rules and regulations. Yet this is not the only theater of conflict; insurance coverage and reimburse- ment constitute another. Yet the regulatory arena is where the identity and power of allied health personnel are largely determined.

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REGULATING ALLIED HEALTH PERSONNEL 243 In carrying out this study the committee encountered many examples of jurisdictional struggles among allied health and other occupations, strug- gles that caused their roles to be constantly shifting. For instance, ophthalmic medical assistants versus optometrists on performing re- ~ . tractions; surgical technologists versus nurses on who should perform various tasks in the operating room; orthoptists versus physical therapists on fitting braces and other or- thotic devices; and audiologists versus hearing aid dispensers in hearing testing. These struggles, in which one occupation seeks to expand its realm of control at the expense of another, are a constant element of regulating health services through licensure. In many cases the issue is which occu- pation is entitled to perform a specific function. In others, the issue is which occupation or occupations have jurisdiction over some portion of the hu- man anatomy. In still others the issue is under what conditions persons in an occupation perform their functions. For example, in many states, phy- sician referral is required for physical therapy or occupational therapy but not for speech therapy. Another important condition of practice is the level of supervision required. These referral and supervision provisions in li- censure statutes define the degree of autonomy of health care workers on the one hand and their degree of availability to consumers on the other. Decisions on these issues by state legislators and regulatory bureaucracies affect the costs, quality, and accessibility of health care services. The great difficulty facing state decision makers is that the impact on costs, quality, and accessibility of any proposed modification in a health occupation's scope of practice, referral, or supervision is rarely clear. The risks and benefits of change are often hypothetical, difficult to measure, and subject to large differences in judgment. Rhetoric and political power frequently substitute for evidence and rational decision making. Rarely are rigorous studies done. One of the clearest examples of this problem is the case of dental hygiene services. In the course of testimony by representatives of the American Dental Hygienists' Association (1987a,b) and the American Dental Asso- ciation (1987) before the committee, committee members learned of the continuing controversy over the required levels of supervision of dental hygienists by dentists. In general, dental hygienists are only permitted to practice (i.e., perform a variety of chiefly preventive services e.g., cleaning teeth, taking x rays, applying topical fluorides, and teaching proper dental hygiene) under the supervision of a licensed dentist. The supervision may be "general," which means that a dentist may delegate a given function. The dentist must be

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244 ALLIED HEALTH SERVICES responsible for its successful performance but does not have to be physically present while the delegated function is carried out. Alternatively, the su- pervision may be "direct," meaning that the dentist must be present in the same room as the hygienist, or "indirect," which requires only that the dentist be present in the treatment facility. Supervision requirements vary among the states. According to the Amer- ican Dental Hygienists' Association (1987b), 38 states permit dental hy- gienists to practice at least some preventive oral health services under general supervision. In some states, general supervision is limited to hos- pitals, nursing homes, adult day care centers, and other institutional set- tings. In Washington State, dental hygienists have practiced unsupervised in long-term care facilities since 1984. The American Dental Association is seeking to tighten supervisory re- quirements for hygienists. In 1986 the association's House of Delegates passed a resolution opposing general supervision and urging state dental societies to eliminate it from state practice acts. The same resolution urged that, in instances in which general supervision could not be removed from the statute, the regulations be changed to require that: a. any patient treated by a dental hygienist first become a "patient of record" of a licensed dentist; b. dental hygiene services be given prior authorization by a dentist no more than 45 days before the services are provided; and c. the dentist examines the patient within a reasonable time after the dental hygiene services are provided. The justification for this resolution was that general supervision endan- gers the dental health of the public. Its effect would be to increase dentists' control of dental hygiene services. Since the resolution was passed, efforts have been made in several states to delete general supervision. A bill to this effect was introduced in Con- necticut in 1987. In Texas, where general supervision has been permitted for over 30 years, the Board of Dental Examiners proposed rules that would require direct supervision of all dental hygiene functions (American Dental Hygienists' Association, 1987b). The Virginia Dental Board, which had been on the verge of liberalizing supervision requirements, decided against such action. Other states are moving to relax their supervision requirements so that dental hygiene services can be provided without the dentist's physical pres- ence. Legislation to this effect has been proposed in Missouri, Ohio, South Carolina, and Wisconsin. At the extreme on this continuum is Colorado, which in 1986 became the first state to allow dental hygienists to provide most of their basic functions without supervision by a dentist. Other func- tions, which are designated as "supervised dental hygiene," require a den- .

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REGULATING ALLIED HEALTH PERSONNEL 245 fist's supervision. Diagnosis, treatment planning, and prescription of therapeutic measures continue to be the responsibility of dentists. The statute imposes disciplinary action on dental hygienists who fail to refer patients to a dentist when the treatment needed is beyond their scope of practice. A lawsuit to overturn the statute failed but is under appeal. In California, 15 dental hygienists are allowed to clean and examine teeth without the supervision of dentists. This demonstration program is one of the state-sponsored Health Manpower Pilot Projects, under which the requirements of state practice acts may be waived for experiments with innovative methods of health care delivery. According to the California Office of Statewide Health Planning and Development (1987), the agency responsible for the program, it "is authorized to approve locally conceived and implemented demonstration projects to prepare and utilize health personnel for new or expanded roles." To qualify for the program, hygienists needed at least 4 years of clinical experience, certification in cardiopulmonary resuscitation, and special training in instrumentation. They are currently providing services in offices and in other settings such as nursing homes. Some make house calls to people who are bedridden. Their case records are reviewed by a dentist. The California Dental Association sued to halt the program on the basis that it was a threat to public health and that the procedures followed by the state and by California State University in approving and implementing the program were inadequate. In August 1987 fudge Rothwell B. Mason of the Sacramento County Superior Court ruled against the dental asso- ciation. His opinion was that the program was consistent with the legisla- ture's intent to enable experimentation with new kinds and combinations of delivery systems and the need for exemptions from the healing arts practice act to permit such experimentation (California Dental Association v. Office of Statewide Health Planning and Development et al., Proceedings, August 28, 1987, California Superior Court, County of Sacramento). In neither the Colorado nor the California cases were the substantive issues resolved; both cases, to date at least, have hinged on procedural matters. In neither case were any data or research findings presented to support arguments about risks or benefits. In addition, no evidence was presented on the issue of what dental hygienists' training includes and what types of responsibilities hygienists are prepared for, on the issue of acces- sibility of services, or on the costs of services. In its testimony to this committee the American Dental Association (1987) stated that it "believes that all segments of the public should receive the same high standard of dental care." The association expressed its concerns about the great responsibility placed on dental care providers by the need to diagnose nondental diseases that manifest symptoms in the mouth and the need to provide services to patients who are severely medically com- promised (American Dental Association, 19871.

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248 ALLIED HEALTH SERVICES Criteria for regulating an occupation include evidence of harm from unregulated practice, evidence that the occupation involves specialized skills, and evidence that the public is not protected by any other means. More recently, a criterion of cost-effectiveness has been added by some states. Minnesota's statute and current regulations (see Appendix F) are an ex- ample of these criteria. The rules spell out in some detail what constitutes evidence of harm, including the kinds of harm that are recognized and how to assess the potential for harm, and the extent of danger inherent in the occupation's functions. Minnesota's regulations also appropriately recognize the rather long list of "other means" for protecting the public: supervision by other practi- tioners, state or federal laws governing devices and substances, employment .. . ~ ... . ,~ . . .. . . . In licensed taal~t~es, federal licensing or other requirements, Avis service procedures, or national certification procedures. A consideration of these other means not only guides the initial decision to regulate at all but can also guide the design of the appropriate regulatory mechanism when one is needed. The criteria for selecting the mode of regulation follow the principle of using the least restrictive activities consistent with public protection (see Subdivision 3 of the Minnesota statute, Appendix F). The least regulatory mode is the strengthening of the base for civil action or criminal prohi- bitions, or both. This is essentially a reliance on the deterrent effect of potential civil actions or criminal penalties. The most regulatory mode is occupational licensure, which prohibits persons who do not meet the state standards from engaging in practice. An intermediate mode is the estab- lishment of title protection through registration or certification. Certification has been used for many years in the field of accountancy. Accountants are certified by the states after meeting certain eligibility cri- teria. These criteria vary among the states, but all states require passing grades in each of four parts of the uniform national examination given by the American Institute of Certified Public Accountants (CPAs). Some states have education requirements; some also require experience in public ac- countancy. Certified status allows an accountant to offer independentjudg- ment about an organization's financial records, the value of its assets, and so forth. In general, large organizations have their financial accounts au- dited and evaluated by CPAs. A lender generally requires an audited state- ment from a firm seeking a loan. The Securities and Exchange Commission requires an audited statement before approving a stock offering. In these capacities, CPAs wield considerable influence, their expertise is widely un- derstood and respected, and they can command substantial salaries. On the other hand, a person can prepare a firm's financial statements, complete tax returns, and perform most accounting functions without being certified. Unless a company wants to borrow money or sell shares to the public, it does not have to pay for the services of a CPA. An individual . .. . . . . .

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REGULATING ALLIED HEALTH PERSONNEL 249 taxpayer is not required to have his or her tax return prepared by a CPA. Thus, there are lower cost options available for a wide variety of accounting services. Using these lower cost and presumably lower quality options is not without risk; an individual might be fined by the Internal Revenue Service or see his or her company fail because of poor accounting services. However, in this field, consumers are able to weigh the risks and benefits and to choose among an array of providers, based on the importance they place on certification and their financial constraints. The concept of economic impact is relatively new in this arena. It makes explicit a concern that the imposition of regulation, whatever its benefits, carries with it certain costs to society. These include any increases in the cost or price of services, insurance premium costs, the costs of additional training, and the costs of operating the regulatory mechanism itself. In some states, these regulatory operating costs are defrayed wholly or in part through licensing fees and thus do not get charged to the consumer. In evaluating the regulatory burden, however, these costs are significant, ir- respective of how they are financed. There is probably merit in having them made public, even if they are paid through licensing fees, as a means of focusing attention on how much regulation costs society. An economic impact statement requirement is very useful. It could and should be expanded to a broader "environmental impact" statement to incorporate other criteria such as access and quality into the considerations. This broader statement would encourage allied health occupations seeking state regulation, other parties at interest, and the states themselves to make as explicit as possible the nature of the trade-offs under consideration. Reforms of the Regulatory Structure and Process The criticisms enumerated above have led to calls that date back to the late 1960s for structural and procedural changes. These recommendations for change have been aimed at increasing the public accountability, effi- ciency, and effectiveness of state regulatory boards. Board Composition Widening the membership of regulatory boards has been one of the most consistent recommendations made by critics of state occupational regulation (e.g., Public Health Service, 1977; Begun, 1981; Cohen, 1980; Shimberg, 1982~. As stated by Tuohy (1976, cited in Begun, 1981, p. 94), "Governments cannot continue to expect that coherent public policy can be achieved by dealing with professional groups as if they were the 'owners' of their respective technologies." The need for public input has generally been associated with consumer involvement, that is, the in- clusion of one or more "lay" members on each licensure board. A number of states have taken this step. These lay members generally are consumers

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250 ALLIED HEALTH SERVICES (much of the impetus for having them came from the consumer move- ment); they may or may not have full membership status voting privileges, for example. Although informed consumers have a great deal to offer to the regu- latory process, there is some question about whether the addition of 1 or 2 consumers to a board with 8 or 10 members of a regulated field, especially if the consumers cannot vote, will have the desired effect of making the board more accountable to the public. More far-reaching recommendations to this end include: Drawing the "public" board members from the appropriate state agency. Bureaucrats would have the advantage of (1) technical knowledge relevant to the task, and (2) a power base from which to exert leverage on other board members. The power would flow from the agency head and, ulti- mately, the governor (Cohen, 19801. Drawing a majority of the board members from outside the regulated occupation. A far cry from one or two "token" consumers, under this proposal boards would be dominated by lay members (Begun, 19811. Drawing board members entirely from persons outside the regulated occupation. Board members could be not only consumers but others with relevant expertise in such Gelds as education, public health, economics, health administration, and health services research (Cohen, 1980~. In the last case, the board could employ as consultants either individuals or a panel of technical advisors drawn from the regulated field. However, because no member of the board would come from the field and because board members would have considerable relevant expertise of their own, they would be likely to avoid "capture" or domination by the field and its associationts). Location of Boards in the State Administrative Structure A second major recommendation to improve accountability has been to strengthen the connections between regulatory boards and one or more state agencies. One approach has been to centralize the administrative support, including recordkeeping, the investigative staff, and other common functions of boards in a single state agency, either the health department or a special depart- ment established for this function. Another approach, recommended by Selden (1970), is to have a single board that regulates all health occupations and that is linked to a state agency that provides all administrative, analytical, and investigative support. Subcommittees from each field would develop policies for that field, subject to approval by the full board. A third approach is to link related health occupations through joint boards. Rather than the single board envisioned by Selden, there would

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REGULATING ALLIED HEALTH PERSONNEL 251 be a number of boards but considerably fewer than the number of regulated occupations. Virginia is moving in this direction with a proposal for a joint board for several allied health occupations. Ctril~tilr~1 rh~ng`~c in the direction of greater accountability are highly desirable. To be fully effective, however, they should apply to all health occupations, notjust to those that are the newest. States will need to examine and probably revise their practice acts for physicians and other health care professionals and to review the structures of regulation for those fields. A double standard, one applicable to allied health fields and one to medicine, dentistry, and nursing, is not desirable. Information for the Public The regulatory process has been criticized for being conducted virtually invisibly. Not only has doing business in a closed fashion been a barrier to public accountability, it has kept the regulatory process from serving an important educational function. Through state regulation the public could become much better informed about the dif- ferent health care occupations, their credentials, and the services they offer. Public education could also increase state citizens' awareness of the im- portance of occupational regulation. Such awareness would be likely to elicit greater interest and participation. No single model for accountability is obviously superior to all others. Each state should use its own mechanisms consistent with the objective of cost-effective public protection. ~~$ ,,,~,,,,~,,$ be.. ~~_.~_v ,,^ ~ The Federal Role The federal government plays a very important role in regulating allied health personnel. Although it does not regulate health occupations directly, it has indirect influence on state regulatory policy by supporting evaluation research, sponsoring policy analyses, and fostering information dissemi- nation. It has direct responsibility for setting standards for eligible providers under Medicare, however, and a shared responsibility with the states for standard setting under the Medicaid program. Medicare conditions of participation, which apply to all institutional providers of health services, are a powerful regulatory tool because providers that do not meet the conditions may not receive payment from the program except in emergency circumstances. These regulations can be used to define the qualifications of fillip,] h`~lth nerconne1 working in Participating hospitals, nursing homes, ~1 ~111~ 11~11 ~$~4$14~4 ~^^~^^~ rid -r~----o ~ 1~ and other health care institutions. The federal influence is also exerted by the actions of the Federal Trade Commission. The commission has conducted and sponsored research on the effects of regulation and has struck down certain anticompetitive prac- tices of regulatory boards such as prohibitions on advertising.

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252 ALLIED HEALTH SERVICES The federal government has taken an important leadership role in health occupations regulation. Reports issued by the U.S. Department of Health, Education, and Welfare in the 1970s were influential in drawing attention to problems in the mechanisms of state regulation. Recommendations from those reports and from studies sponsored by the Labor Department helped shape the new directions in state regulation. The Bureau of Health Professions has supported studies of occupational roles that are useful in devising entry and practice standards. The bureau has also helped develop and disseminate information on state regulatory activities through its support of the Clearinghouse on Licensure, Enforce- ment, and Regulation of the Council of State Governments. In addition, the bureau has supported the National Commission for Health Certifying Agencies (NCHCA), a body that sets standards for or- ganizations that certify allied health personnel. NCHCA sets standards that are designed to ensure that certifying agencies are accountable to individ- uals seeking certification, to their employers, to health care payers, and to the public. (A copy of their standards is attached as Appendix G.i The federal Medicare program has a significant impact on allied health personnel through the way it defines covered services. By means of reg- ulation, the secretary of the Department of Health and Human Services can define the qualifications (e.g., licensure) of personnel providing services such as physical therapy, occupational therapy, and speech therapy. Private Control Mechanisms Private recognition of competence also offers some assurance to the public; it may take several forms. Membership in an association is an in- dication that an individual has met certain standards for admission. The standards may include qualifications of education or experience, moral character, and so on. In a number of allied health fields, a basic requirement of membership is graduation from an education program approved by CAHEA. Dental hygiene programs are accredited by the American Dental Association. Physical therapy education programs are accredited by the American Physical Therapy Association. Certification by a private agency or association generally imposes more rigorous standards than those required for association membership. Cer- tification has been defined as: . . . the process by which a nongovernmental agency or association grants recog- nition to an individual who has met certain predetermined qualifications specified by that agency or association. Such qualifications may include graduation from an accredited or approved training program, acceptable performance on a qualifying examination, and/or completion of some specified amount or type of work expe- rience. (Shimberg, 1984)

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REGULATING ALLIED HEALTH PERSONNEL 253 In a paper prepared for this committee, Carpenter (1987) notes that cer- tification establishes "standards of competence" and then grants an indi- vidual a certificate allowing them to use an occupational title, for example, "registered dietician." ("Registered" is a very confusing term because it may be used to mean licensed, as with registered nurses, or certified, as in this case.) This mechanism is, of course, analogous to certification by a state, except that it does not include legal prohibition against the use of the title by persons not meeting the standards. Historically, licensure has been concerned with minimum competency, whereas certification has been reserved for those meeting considerably higher standards. In medicine, for example, certification by a speciality board was (and is) viewed as a "badge of excellence" (Shimberg, 19841. This distinction is less clear-cut today, when in some fields certification attests to basic entry standards and in others it attests to special achievement. Two forms of private accreditation are used as quality assurance mech- anisms for allied health personnel. In the context of credentialing allied health personnel, accreditation most commonly refers to a process through which a private association or agency "grants public recognition to a school, institute, college, university, or specialized program of study having met certain established qualifications or standards" (Shimberg, 19841. Educa- tional accreditation is a form of peer review that is meant "to provide a professional judgment of the quality of the educational institution or pro- gram" (Committee on Allied Health Education and Accreditation, 1987~. The second form of accreditation that is a quality control mechanism for allied health personnel is the accreditation of hospitals and nursing homes by the joint Commission on the Accreditation of Health Care Or- ganizations. The joint commission promulgates standards that include qual- ifications of key hospital personnel. Many of these standards apply to allied health personnel (see Table 7-3~. CONCLUSIONS AND RECOMMENDATIONS In light of potential future shortages of allied health personnel and the need to find a reasonable balance between health care costs and quality, the committee believes that it is important to maintain flexibility in the use of existing personnel and a variety of routes of entry for new personnel. It appears that widespread use of licensure carries with it higher costs to consumers, reduced access to health care services, and reduced flexibility for managers. People in health care careers are inhibited from changing fields and from advancing within their fields by rigid requirements imposed by state regulatory mechanisms. Although these control mechanisms are designed and carried out in the stated interest of protecting the health and welfare of the public, their effectiveness in this regard has been mixed at best.

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254 ALLIED HEALTH SERVICES TABLE 7-3 Joint Commission on Accreditation of Healthcare Organizations' Accreditation Standards for Hospitals Field Summary of Relevant Standards (if any) Clinical laboratory The director is a member of the medical staff and preferably a technology board-certified pathologist. There are sufficient qualified laboratory technologists and supportive staff to perform the required tests. A qualified technologist is a graduate of an approved medical technology program or has equivalent 1 1 w' 1 ~ 1 education, training, and/or experience; meets current legal requirements of licensure/registration; and is currently competent. Dietetics A qualified dietitian dispenses the nutritional aspects of patient care and ensures that quality nutritional care is provided to patients. Medical records A hospital must employ or have as a consultant a registered record administrator or an accredited record technician. If consultants only are used, medical record supervisors are to demonstrate competence. Physical therapy See rehabilitation services. Occupational therapy See rehabilitation services. Radiology The director of the radiology service is to determine the qualifications and competence of department personnel; at least one qualified radiologic technologist is available; a technologist does not independently perform diagnostic fluoroscope except under certain circumstances. The director of the nuclear medicine service is to determine the qualifications and competence of department personnel who are not independent practitioners. "When radiation oncology procedures are performed in the hospital, designated qualified technologists are assigned as needed." Rehabilitation services Each individual providing physical rehabilitation services must meet relevant licensure, certification, or registration requirements. Separate services are defined, including occupational therapy, physical therapy, prosthetic and orthotic services, psychological services, recreation therapy, social work services, speech-language pathology or audiology services, and vocational rehabilitation services. No specific staffing standards are given beyond the general one. Separate standards require that comprehensive rehabilitation services be provided "in an interdisciplinary manner," and that the quality and appropriateness of these services be monitored and evaluated.

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REGULATING ALLIED HEALTH PERSONNEL TABLE 7-3 Continued 255 Field Summary of Relevant Standards (if any) Respiratory therapy Respiratory care services are to be provided by a sufficient - number of qualified persons under competent medical direction. If warranted, services are supervised by a technical director registered or certified by the National Board for Respiratory Therapy, Inc. Other qualified personnel may provide services commensurate with their training, experience, and competence; these include registered respiratory therapists or certified technicians; persons with equivalent education or experience; qualified cardiopulmonary technologists; and appropriately trained licensed nurses. SOURCE: Accreditation Manual for Hospitals (1988). Statutory certification, which legally reserves the use of a title to persons with specific qualifications, affords most of the benefits of licensure and avoids many of the costs. In conjunction with public education, it gives consumers the opportunity to choose among providers knowledgeably. It does not prevent consumers from choosing lower quality or lower cost alternatives. It permits institutional employers some flexibility in their staff- ing. It permits innovation new careers may provide new cost-effective methods of diagnosis and treatment. The committee recommends statutory certification for fields in which the state determines there is a need for regulation because this form of regulation offers most of the benefits of licensure with fewer of its costs. Medicare and other third-party payers should accept state title certifi- cation as a prerequisite for reimbursement eligibility. Such certification can and should be based on examinations and other eligibility criteria the states may establish. The committee endorses the establishment of sunrise criteria to guide states' decisions about whether to regulate health occupations and, if so, how. These decisions should follow three basic principles: 1. the protection of the public is the sole reason for states to regulate health occupations; 2. the least restrictive regulatory mechanism consistent with public pro- tection should be selected, taking into account other means that are in place; and 3. if, after due deliberation, the decision is made to regulate an occu- pation, it must be followed by a continuing commitment of resources on the part of the legislature, the governor, and the relevant administrative agencies.

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256 ALLIED HEALTH SERVICES State regulatory structures and procedures must be improved if they are to be effective. In most states the composition of boards, the requirements for entry, and the flow of information to the public are not fully consistent with the public interest. The committee recommends that states strengthen the accountability and broaden the public base of their regulatory mechanisms. In the near term, the committee suggests the following: Licensing boards should draw at least half of their membership from outside the licensed occupation; members should be drawn from the public as well as from a variety of areas of expertise such as health administration, economics, consumer affairs, education, and health ser- vices research. Flexibility in licensure statutes should be maintained to the greatest extent possible without undue risk of harm to the public. This may mean, for instance, allowing multiple paths to licensure or overlapping scopes of practice for some licensed occupations. The regulatory process should be conducted as openly as possible and should produce a flow of information to the public, including: the scope of practice of the occupation as defined by state law and regulation; the eligibility requirements for entry into the occupation; basic information about licensees, including the status of their license and any disciplinary actions taken by the state, as well as basic data such as educational background, which should be collected as part of the li- censing process; and board membership and procedures, especially procedures for filing complaints against licensed professionals. Regulatory boards should be well connected to the state bureaucracy. If a state requires graduation from an accredited educational program for licensure, the state should take an active interest in the accreditation requirements to ensure that they are consistent with the state's interests. Finally, the committee believes that decisions by states, accrediting bodies, and health care payers regarding scope of practice, referral, and super- vision should be better informed. The Bureau of Health Professions (or another future focal point for allied health personnel in the Depa~-l'''ent of Health and Human Services) should sponsor a body with members drawn from allied health and other health professions and from the health and social science research communities to assess objectively the evi- dence bearing on jurisdictional issues. This body, in consultation with other experts and interested parties, should consider issues of risk, cost,

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REGULATING ALLIED HEALTH PERSONNEL 257 quality, and access. It should draw on available scientific evidence and identify topics on which research is needed. Well-designed experiments and demonstrations of innovative roles for allied health personnel will provide valuable evidence to guide regulatory policy. REFERENCES Accreditation Manual for Hospitals. 1988. Chicago: Joint Commission on Accreditation of Healthcare Organizations. American Dental Association. 1987. Testimony before the IOM Committee to Study the Role of Allied Health Personnel's Hearing on Regulation. National Academy of Sci- ences, Washington, D.C. July. American Dental Hygienists' Association. 1987a. Paper submitted to the IOM Committee to Study the Role of Allied Health Personnel's Hearing on Regulation. National Acad- emy of Sciences. Washington, D.C. July. American Dental Hygienists' Association. 1987b. Testimony before the IOM Committee to Study the Role of Allied Health Personnel's Hearing on Regulation. National Acad- emy of Sciences, Washington, D.C. July. Begun, I. W. 1981. Professionalism and the Public Interest: Price and Quality in Optom- etry. Cambridge, Mass.: MIT Press. California Office of Statewide Health Planning and Development.1987. Health Manpower Pilot Projects Program: Annual Report to the Legislature and the Healing Arts Li- censing Boards. Sacramento: State of California Office of Statewide Health Planning and Development. Carpenter, E. S. 1987. State regulation of allied health personnel trends and emerging issues. Background paper commissioned by the Institute of Medicine Committee to Study the Role of Allied Health Personnel. National Academy of Sciences, Washington, D.C. Carroll, S. L., and R. i. Gaston. 1977. Occupational Licensing: Final Report. Washington, D.C.: National Science Foundation. Cohen, H. S. 1980. On professional power and conflict of interest: State licensing boards on trial. Journal of Health Politics, Policy and Law 5(2):291-308. Committee on Allied Health Education and Accreditation. 1987. Allied Health Education Directory, 1987. 15th ed. Chicago: American Medical Association. Gaumer, G. L. 1984. Regulating health professionals: A review of the empirical literature. Milbank Memorial Fund Quarterly/Health and Society 62(3):380-416. Goldman, S. K., and W. D. Helms. 1983. The regulation of the health professions. A policy review prepared for the Commission of Health Regulatory Boards of the Com- monwealth of Virginia. Richmond, Va. October. Holen, A. S. 1977. The Economics of Dental Licensing. Arlington, Va.: Center for Naval Analysis. Institute of Medicine, Committee to Study the Role of Allied Health Personnel. 1987. Mechanisms for Controlling the Quality of Allied Health Personnel. Public hearing held on July 1 at the National Academy of Sciences, Washington, D.C. Maurizi, A. 1974. Occupational licensing and the public interest. journal of Political Econ- omy 82:399-413. McCready, L. A. 1982. Emerging health care occupations: The system under siege. HCM Review (Fall) :71 -76.

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258 ALLIED HEALTH SERVICES National Advisory Commission on Health Manpower. 1967. A Report by the Committee on Health Manpower, Vol. 1. Washington, D.C.: Government Printing Office. Shimberg, B. 1982. Occupational Licensing: A Public Perspective. Princeton, No.: Edu- cational Testing Service. Shimberg, B. 1984. The relationship among accreditation, certification and licensure. Federal Bulletin (April): 99- 1 15. U.S. Department of Health, Education, and Welfare, Office of the Assistant Secretary for Health and Scientific Affairs. 1971. Report on Licensure and Related Health Personnel Credentialing. Washington, D.C.: Government Printing Office.