NURS 4

Health Professions Regulation and Licensing

Definitions and Purpose of Regulation

Regulation, as defined in Black’s Law Dictionary, means “control over something by rule or restriction” (Garner, 2014, p. 1475). Health professions regulation is needed as a mechanism to protect the interests of public safety. There is extraordinary diversity and variability in health professions education programs—and, therefore, in licensure and other forms of credentialing. Laypersons cannot judge the competency of a health professional or determine whether that professional’s practice meets acceptable and prevailing standards. For these reasons, because of the potential risk for harm and because of the intimate nature of nursing and health care, states protect the public by establishing laws to regulate the profession (Russell, 2012). Health professions regulation seeks to safeguard the public by acting as gatekeeper for entry into the health professions and by providing for ongoing maintenance of acceptable standards of practice for those professions. Practice acts, and the rules promulgated from those practice acts, constitute government regulatory oversight of professions.

Practice acts vary by state, but most include the same basic elements (Russell, 2012):

Creation of a agency/board that serves as the decision-making body Definitions, standards, and scopes of practice Scope of the board’s power and authority and its composition Standards for educational programs Types of titles, licensure, and certification Title protection Licensure requirements Grounds for disciplinary action, including due process (remedies) for the licensee charged with violation of the practice act or regulations

Requirements for mandatory continuing education and/or competency requirements for licensure and relicensure are also found in practice acts.

The board’s rule-making authority is specified in the practice act as one of its “powers and duties.” This rule-making authority generally includes categories such as initial licensing requirements, standards of practice, delegation standards, requirements for prelicensure registered nurse (RN) and licensed practical nurse/licensed vocational nurse (LPN/LVN) educational programs, advanced practice registered nurse (APRN) standards and requirements for practice and prescribing, disciplinary procedures, and standards for continuing education or competence.

It cannot be presumed that silence of the law on an issue implies legislative intent for the BON to write a rule. When there is no prior statutory authority to address an issue, the legislative process must be initiated to allow the agency authority to promulgate new, specific regulations.

Example: An APRN with prescribing authority petitions the BON to clarify whether prescriptive authority for Schedule II controlled substances is within the scope of practice for the APRN. The board’s staff refers the APRN to a provision in the statute that allows the APRN to “prescribe drugs and therapeutic devices” as long as the APRN practices in collaboration with a physician and in a way consistent with the nurse’s education and certification. The staff concludes that the phrase “prescribe drugs and therapeutic devices” may include Schedule II controlled substances if permitted in the APRN‒physician collaboration agreement. No specific language is found in the law that authorizes the prescribing of Schedule II controlled substances, but neither is it specifically prohibited.

The medical board, which monitors BON opinions regarding potentially overlapping areas of practice, reads the BON’s opinion and requests a state attorney general’s opinion. The attorney general concludes that the BON may not extend the scope of practice of the APRN through either opinion or regulation. The expressed will of the legislature must be sought using the legislative process. Subsequently, the BON seeks a legislative sponsor to introduce a bill permitting APRNs to specifically prescribe Schedule II controlled substances. Not all state boards of nursing are granted statutory authority to express formal opinions; some must rely on the specific language in the practice act and regulations, the official opinions of an attorney general’s office, or court decisions.

History of Health Professions Regulation

Physicians were the first healthcare professionals to gain legislative recognition for their practice. Most states had physician licensing laws in place by the early 1900s. Nursing soon followed suit. North Carolina was the first state to establish a regulatory board for nurses in 1903, and by the 1930s, state licensing had been enacted in 40 states (Hartigan, 2011). Physician scopes of practice are broad; they are unlimited in many states. Historically, this has been problematic for nursing and other nonphysician healthcare providers seeking to define their unique scope, particularly in areas that may overlap with physicians’ services. The history of nursing regulation has been characterized by efforts to accommodate this medical preemption (Safriet, 1992)

Early nursing regulation was permissive (voluntary). Systems were developed that allowed nurses to register with a governing board—hence the title “registered nurse.” In some states, nurses were registered by the medical board before separate boards of nursing were established. Registration is a minimally restrictive form of state regulation and does not usually require entrance qualification (e.g., examination). Between the 1930s and 1950s, states enacted mandatory licensure laws (NPAs) requiring practicing nurses to obtain licensure with the state regulatory agency. These early NPAs defined nursing as a dependent practice focused on physician order implementation. The American Nurses Association model definition, published in 1955, laid the groundwork for NPAs to define independent functions for nurses, although the model reaffirmed prohibitions against medical diagnosis and prescribing (Hartigan, 2011).

Over time, BONs began establishing licensure criteria and administering licensure examinations. The early licensure examinations were BON-constructed paper-and-pencil examinations, performance examinations, or a combination. During that time, BONs also independently established examination passing standards. Statutory authority to regulate schools of nursing and establish requirements for school structure, faculty, and curricula were added to NPAs. Because interstate mobility was becoming more common, states developed reciprocity agreements with other states. The National Council of State Boards of Nursing (NCSBN) Nurse Licensure Compact has since replaced reciprocity. Not all states participate in the compact, and this complex process should not be confused with the obsolete two-state reciprocal arrangements (Hartigan, 2011; NCSBN, 2014b). By the 1940s, the need for a standardized licensure exam had become apparent. In 1944, the State Board Test Pool Examination (SBTPE) was established by the National League for Nursing (NLN). The SBTPE assured standardization and relieved state BONs of the burdens associated with writing and grading the examination. Over the years, questions about potential for conflict of interest were raised. Although individual BONs set their own passing standards, authority for the creation and control of the examination had been absorbed by a professional association (the NLN). This relationship set up conflicts between governmental regulation and professional self-regulation, which should be separate and independent. Concurrently, BON leaders created a forum in which they could meet and discuss matters of common interest, although that forum was structured as a council of the American Nurses Association (ANA). This created additional conflict between BONs’ prescribed governmental duty to establish licensure standards and professional associations’ rights and responsibilities to remain independent of governmental influence. In 1978, the NCSBN was formed, with the assistance of a Kellogg Foundation grant, to address these issues. NCSBN is autonomous and represents the states’ interests rather than those of professional nursing organizations (Hartigan, 2011). History of Advanced Practice Registered Nurse Regulation In the 1960s, the birth of two federal entitlement programs, Medicare and Medicaid, increased the number of individuals with access to government-subsidized health care. At the same time, a shortage of primary care physicians was predicted, particularly in rural areas. A window of opportunity opened, and the first formal nurse practitioner (NP) programs were begun, with the goal to increase access to primary care in the rural areas where physicians were unlikely to locate. In 1971, Idaho became the first state to legally recognize diagnosis and treatment as part of the scope of nurse practitioners. APRN (nurse practitioner) regulation in Idaho was accomplished through a joint agreement between the state boards of nursing and medicine. The Idaho model set a precedent for other states to include some form of joint nursing and medical board oversight for APRN regulation. The joint regulation model compensated for the broad definitions of medical practice but was a compromise because advanced practice nursing was still considered to constitute “delegated medical practice,” requiring some medical board oversight (Safriet, 1992). The struggle to define APRNs’ scope of practice and determine the necessity of medical board oversight continues in some states. Both the ANA and the NCSBN have proposed model rules and regulations for the governing of advanced practice nursing. The actual practice acts are inevitably a product of individual states’ political forces, so titles, definitions, criteria for entrance into practice, scopes of practice, reimbursement policies, and models of regulation are state specific. Since 1988, The Nurse Practitioner has published a map and summary of annual survey data from each state’s BON and nursing organizations relative to the legislative status of advanced practice nursing. Significant advances have been made in many states, particularly regarding independent APRN practice without direct physician supervision. In 2017, 15 states/jurisdictions report that NPs are regulated solely by a BON and have both independent scope of practice and prescriptive authority without physician supervision, delegation, consultation, or collaboration. In 10 states, NPs are regulated by a BON, have full autonomous practice and prescriptive authority, but additionally must complete a postlicensure/certification supervision period or engage in a collaboration or mentorship. In the remaining states, NPs are regulated either solely by a BON or in combination with BON oversight (Phillips, 2017). Methods of Professional Credentialing Various methods are used to credential health professionals. The method accepted in a particular state is determined by the state government and based on at least two variables: (1) the potential for public harm if safe and acceptable standards of practice are not met and (2) the profession’s degree of autonomy and accountability for decision making. Historically, government agencies have been encouraged to select the least restrictive form of regulation to achieve public protection (Pew Health Professions Commission, 1994). Today, four methods are used in the United State for credentialing and regulation of individual providers. These are described next, beginning with the most restrictive method and progressing to the least restrictive method. Licensure A license is “a privilege granted by a state. . . the recipient of the privilege then being authorized to do some act. . . that would otherwise be impermissible” (Garner, 2014, p. 1059). Licensure is the most restrictive method of credentialing. Anyone who practices within the defined scope must obtain the legal authority to do so from the appropriate administrative state agency. Licensure serves as a barrier to those who are unqualified to perform within a specific scope of practice. Licensure also protects the monetary interests of those who are licensed to perform certain acts by limiting economic competition with unlicensed individuals. Licensure implies competency assessment at the point of entry into the profession. Applicants for licensure must pass an initial licensing examination, then comply with continuing education requirements or undergo competency assessment by the regulatory body that provides oversight for that profession. Because competency is unique to the individual professional and specialty, it is difficult to measure; most licensing agencies require mandatory continuing education in lieu of continued competency assessment for license renewal. Licensure offers the public the greatest level of protection by restricting use of a specific title and a scope of practice to professionals who meet these rigorous criteria and hold a current valid license. Unlicensed persons cannot identify themselves by the title identified in law (e.g., medical assistants cannot hold themselves out as nurses), and they cannot lawfully perform any portion of the scope of practice, unless their own practice act allows them to provide such services because of overlap. Licensees are held accountable to practice according to provisions in law and rule and to adhere to legal, ethical, and professional standards. A licensee holds greater public responsibility than an unlicensed citizen. Therefore, disciplinary action may be taken against licensees who have violated law or rule. Notably, a revocable license means that the legal authority (e.g., a BON) may divest the licensee of the license if it is deemed that the license holder has violated law or regulations and that it is in the best interest of the public. Health professions are largely regulated by licensure because of the high risk of potential for harm to the public if unqualified or unsafe practitioners are permitted to practice. Registration Registration is the “act of recording or enrolling” (Garner, 2014, p. 1474). Registration provides for a review of credentials to determine compliance with criteria for entry into a profession and permits the individual to use the title “registered.” Registration provides title protection but does not preclude individuals who are not registered from practicing within the scope of practice, so long as they do not use the title “registered” or misrepresent their status. Registration does not necessarily imply that prior competency assessment has been conducted. Some state laws may have provisions for removing incompetent or unethical providers from the registry or for “marking” the registry when a complaint is lodged against a provider. However, removing the person from the registry does not assure public protection, because the individual may practice without use of the title. An exemplar is the states’ Nurse Aide Registry, which tracks individuals who have met criteria to be certified for employment in long-term care settings; this registry was required by the Omnibus Budget Reconciliation Act of 1987. Certification A certificate is “an official document stating that a specified standard has been satisfied” (Garner, 2014, p. 275). In nursing, certification usually refers to the voluntary process requiring completion of a specialty-focused education program, competency assessment, and practice hours. This type of certification in nursing is granted by proprietary professional nursing organizations and attests that the individual has achieved a level of competence in nursing practice beyond entry-level licensure. Certification awarded by proprietary organizations does not have the force and effect of law. However, the term certification may also be used by state government agencies as a regulated credential; states may offer a “certificate of authority” or an otherwise-titled certificate to practice within a prescribed scope of practice. In this case, certification is required by law for practice in the specific role. For example, an APRN may need to hold a certificate as a nurse practitioner from a proprietary organization to qualify for a certificate of authority from a state BON to practice as an NP in that state. Most states have enacted regulations requiring nationally recognized specialty nursing certification for an APRN to be eligible to practice in the advanced role. Astute consumers may ask whether a provider is certified as a means of assessing competency to practice. Employers also use certification as a means of determining eligibility for certain positions or as a requirement for internal promotion. Recognition Recognition is “confirmation that an act done by another person was authorized. . . the formal admission that a person, entity, or thing has a particular status” (Garner, 2014, p. 1463). Official recognition is used by several boards of nursing as a method of regulating APRNs and implies the board has validated and accepted the APRN’s credentials for the specialty area of practice. Criteria for recognition are defined in the practice act and may include requirements for certification. Professional Self-Regulation Self-regulation occurs within a profession when its members establish standards, values, ethical frameworks, and safe practice guidelines exceeding the minimum standards defined by law. This voluntary process plays a significant role in the regulation of the profession, equal to legal regulation in many ways. Professional standards of practice and codes of ethics exemplify professional self-regulation. National professional organizations set standards for specialty practice. By means of the certification process, these organizations determine who may use the specialty titles within their purview. Documentation of continuing education and practice competency or reexamination is usually required for periodic recertification. Standards are periodically reviewed and revised by committees of the membership to assure they reflect current practice. Although professional organizations develop standards of practice, they have no legal authority to require compliance by certificate holders. Administrative licensing agencies retain that authority but look to prevailing professional standards of practice when making decisions about what constitutes safe and competent care. Legal regulation and professional self-regulation are two sides of the same coin, working together to fulfill the profession’s contract with society. Regulation of Advanced Practice Registered Nurses The evolution of APRN practice across the United States has been inconsistent because the U.S. Constitution gives states the right to establish laws governing professions and occupations. As a result, titles, scopes of practice, and regulatory standards are unique to each state. To bring some uniformity to the education and regulation of advanced nursing practice, the NCSBN convened an Advanced Practice Task Force in 2000, at the behest of its BON membership, and invited the American Association of Colleges of Nursing (AACN) to join in a consensus-building process. Together they developed the Consensus Model for Regulation: Licensure, Accreditation, Certification, and Education (LACE). The LACE report proposed definitions of APRN practice, titling, and education requirements. It also described an APRN regulatory model, identified APRN roles/population foci, and offered strategies for implementation (APRN Joint Dialogue Group, 2008). This model served as the basis of BON regulation of advanced practice nursing for some years. In 2016, however, the NCSBN convened an APRN Roundtable to consider revisions in education, certification, and other factors and issues currently facing APRN regulation (NCSBN, 2016). APRN regulation is also dependent on relationships between national nursing organizations and their affiliate certifying organizations (e.g., the ANA and the American Nurses Credentialing Center [ANCC]). Together these organizations play important roles in shaping APRN preparation and practice. The certifying organizations are nongovernmental bodies that develop practice standards and examinations to measure the competency of nurses in an area of clinical expertise. BONs require APRNs to hold a graduate degree in nursing and national certification in the specialty area relevant to their educational preparation. BONs also establish rules allowing acceptance of national APRN certification examination results according to predetermined criteria. The NCSBN guidelines (2002) continue to serve state BONs in determining those criteria. Historically, the courts have held that state boards may not abdicate their authority by passively accepting examinations from independent bodies without having conducted a thorough evaluation of the examination’s regulatory sufficiency and legal defensibility (NCSBN, 1993). The basis for regulatory sufficiency and legal defensibility of licensure or certification examinations includes two elements: (1) the ability to measure entry-level practice, based on a practice analysis that defines job-related knowledge, skills, and abilities; and (2) development of examinations using psychometrically sound test construction principles.