CHAPTER4GovernmentResponse-Regulation3.docx
The State Regulatory Process
The 10th Amendment of the U.S. Constitution specifies that all powers not specifically vested in the federal government are reserved for the states. One of these powers is the duty to protect its citizens (police powers). This power is translated in the form of states’ authority and interest in regulating the professions to protect the health, safety, and welfare of its citizens. Administrative agencies are given referent power, through their legislatively enacted practice acts, to promulgate (write) regulations and enforce both the laws and the regulations for which they are responsible. These administrative agencies have been called the “fourth branch” of government because of their significant power to execute and enforce the law. Boards of Nursing Nurse practice acts vary by state, but all NPAs include the major provisions, or elements, discussed earlier in this chapter. Provisions included in NPAs focus on a central mission—protection of the public safety. There are 60 boards of nursing (BONs) in the United States, including those in the 50 states, the District of Columbia, and the U.S. territories; each of these is known as a jurisdiction. Each BON is a member of the NCSBN. Some states have separate boards for licensing RNs and LPNs/LVNs. Several states regulate RNs and/or LPNs/LVNs through multiprofessional boards, which have jurisdiction over a variety of licensed professionals such as physicians, nurses, and dentists. As members of the NCSBN, BONs represent the interest of public safety by providing oversight of the construction and administration of the National Council Licensure Examinations (NCLEX). BONs are allowed the privilege of using these examinations and meet to discuss and act on matters of common interest (NCSBN, 2008). Composition of the Board of Nursing Boards of nursing are generally composed of licensed nurses and consumer members. In most states, the governor appoints members. An exception is North Carolina, where board members are elected by nurses licensed to practice in the state. Some NPAs designate specific board member representation—for example, from advanced practice nursing or nursing education, and in the case of joint boards, representation from LPNs/LVNs in addition to RNs/APRNs. In other states, criteria for appointment comprise only licensure and state residency. Nurses interested in serving as board members may look to their professional associations to secure endorsements or ask for support from their state district legislators. Knowing the composition of the board and its vacancy status allows professional organizations to influence the representation on the board. Board Meetings Most state administrative procedures acts (APAs) require boards to post public notice of meetings and make agendas available, usually 30 days prior to the meeting. State government agencies must comply with open meeting (“sunshine”) laws, which permit the public to observe and/or participate in board meetings. Board meetings may vary in their degree of formality. Public participation is usually permitted, but open dialogue between board members and the public is generally limited. Opportunities to address the board may be scheduled on the meeting agenda (e.g., during an “open forum” time) and may require advance notification of the individual’s name, topic, and the organization represented (if applicable). Boards may go into closed executive session for reasons specified in the state’s administrative procedures act (e.g., to obtain legal advice, conduct contract negotiations, and discuss disciplinary or personnel matters). Boards must comply with APA regulations regarding subject matter that may be discussed in an executive session and report out of executive session when the public session resumes. Board meeting participants include board members (appointed or elected), board staff (employees of the board), and legal counsel for the board. Legal counsel advises the board on matters of law and jurisdiction. Some boards may have “staff” counsel, but many state boards receive advice only from an assigned representative of the state attorney general’s office, known as an assistant attorney general (AAG). All voting is a matter of public record, and board action occurs only in open public session. When board members vote, they must take into account implications for the public welfare and safety, the legal defensibility of the outcome of the vote, and the potential statewide impact of the decision. The board must act only within its legal jurisdiction. BONs may publish action summaries of board meetings in their newsletters, in addition to articles written by board members and staff that explain law and rule. BON newsletters typically include disciplinary actions taken against licensees during board meetings. The nature of the offense is included in some states’ newsletters. Some states mail newsletters to licensees, but many BONs now make newsletters available only electronically. Monitoring the Competency of Nurses: Discipline and Mandatory Reporting Licensed nurses are accountable for knowing the laws and regulations governing nursing in the state of licensure and for adhering to legal, ethical, and professional standards of care. Some state regulations include standards of practice; other states may refer to professional or ethical standards established by professional associations. Employing agencies also define standards of practice through policies and procedures, although these are separate from, in addition to, and superseded by the state’s NPA and regulations. Most NPAs include provisions for mandatory reporting that require employers to report violations of the NPA or regulations to the BON. Licensed nurses also have a moral and ethical duty to report unsafe and incompetent practice to the BON. In addition, the public may file complaints against licensees with BONs. The NPA provides the BON with authority to investigate complaints against licensees and potentially take action on the license, including the license or certificate to practice as an APRN. State APAs assure that licensees subject to disciplinary action are provided due process. When a nurse is found, through the administrative processes, to have violated provisions of the NPA or regulations, the BON can take action on the license; these actions may include a reprimand, fine, suspension, suspension of license with stay (i.e., probation), permanent revocation of license, or any other action permitted by the NPA. A nurse who holds a multistate license (i.e., a license that permits a nurse to practice in more than one state in accordance with a multistate compact agreement) is held accountable for knowing and abiding by the laws and regulations of the state of original licensure as well as the compact state in which the nurse practices. Multistate regulation is discussed in more detail later in this chapter. Nurses with multistate licenses should be aware that ignorance of the law in any state of licensure and/or practice does not excuse misconduct. Changing the Rules Revising or Instituting New State Regulations State agencies exercise their authority and duty to promulgate regulations amplifying their laws by following the state’s administrative procedures act. The administrative procedures act of each state specifies the rule-making process, including requirements for public notification and for providing an opportunity for public comment. State rule-making processes differ. For example, some states designate government commissions or committees as the authorities for review and approval of regulations, whereas other states submit regulations to the general assembly or to committees of the legislature. Nevertheless, all state rule-making processes share some common elements: Public notice that a new regulation or modification of an existing regulation has been proposed Opportunity to submit written comment or testimony Opportunity to present oral testimony at a rules hearing Agency filing of the rule in final form Publication of the final regulation in a state register or bulletin Public comment may be very influential in determining the final outcome. The administrative agency drafting the regulation has discretion in determining which amendments are made and may make amendments based on public input prior to final filing. The time frame for implementation of new or revised regulations varies according to the state’s administrative procedures act. Generally, effective dates are within 30 to 90 days of publication of the final regulation. In some states, the agency is required to prepare a fiscal impact statement, providing an estimate of the costs that will be incurred as a result of the rule, both to the agency and to the public. Board Rule-Making Processes BONs make regulatory decisions using methods similar to those used by other public officials in executive-branch agencies. When drafting new rules or revising existing rules, BONs examine matters of public safety and issues administering existing regulations, invite comment from stakeholders (in particular, nursing organization representatives), and may seek counsel from BON advisory committees or task forces. Leveraging participation opportunities early in the rule-drafting process is important, in addition to providing testimony during formal hearings. It is also imperative to appreciate that the process becomes complex when it is confounded by the perspectives, values, and ethics of a variety of stakeholders. Because rule making involves dealing with both political complexities and content issues, BONs may use policy design or process models to facilitate decision making. Using a process model that is both familiar in nursing and adaptable to the health policy arena—for example, evidence-based practice (EBP)—can facilitate a BON’s rule making because it provides an organized framework for problem solving. The South Dakota BON has successfully used an evidence-informed health policy (EIHP) model to analyze one of its policies (Damgaard & Young, 2017). The EIHP model is adapted from Melnyk and Fineout-Overholt’s (2015) EBP model and is a paradigm and problem-solving approach to health policy decision making. Like EBP, EIHP combines the use of evidence with issue expertise and stakeholder values and ethics to inform and leverage policy discussion and negotiation. The hoped-for outcome is the best possible health policy agenda and improvements (Loversidge, 2016b). Using the term informed rather than based shifts the focus of evidence to its realistic uses in policy arenas, which include informing and influencing stakeholders, as well as mediating dialogue; it also acknowledges the complexity of multiple factors, relationships, and rapidly shifting priorities inherent in the political process (Loversidge, 2016a). Since EIHP is a full-cycle process model, it can facilitate decision making throughout the phases of regulation promulgation, rollout, implementation, and evaluation. The model includes three components and seven steps, summarized in TABLE 4-1. In particular, it makes use of the PICOT question. As used in health policy, the “P” part of this question—Population of interest—generally focuses on the consumer. The “I” (Intervention) refers to the policy change. “C” is the Comparison—the current policy or lack thereof. The “O” component describes the anticipated Outcome after policy implementation (Loversidge, 2016b). “T” is the Time needed to implement the policy. TABLE 4-1 Loversidge’s Evidence-Informed Health Policy Model: Components and Steps Components of EIHP Steps of EIHP External evidence: Includes best research evidence, evidence-informed relevant theories, and best evidence from opinion leaders, expert panels, and other relevant sources. Issue expertise: Includes data from sources such as professional and healthcare associations/organizations and government agencies; also includes professions’ understanding/experience with the issue; may include other data resources. Stakeholder values and ethics: Considers the values and ethics of healthcare providers, policy shapers, healthcare consumers, and others. Step 0: Cultivate a spirit of inquiry in the policy culture or environment. Step 1: Identify the policy problem; ask a policy question in the form of a PICOT question. Step 2: Search for/collect relevant/best evidence. Step 3: Perform critical appraisal of the evidence. Step 4: Integrate best evidence with issue expertise and stakeholder values and ethics; the result will be the desired health policy decision/change. Step 5: Contribute to the health policy development/implementation process. Step 6: Frame the policy change for dissemination. Step 7: Evaluate the effectiveness of the policy change and disseminate findings. Data from Loversidge, J. M. (2016b). An evidence-informed health policy model: Adapting evidence-based practice for nursing education and regulation. Journal of Nursing Regulation, 7(2), 27–33. Monitoring State Regulations Administrative agencies promulgate hundreds of regulations each year. In this rapidly changing healthcare environment, conflicts related to definitions and scopes of practice, right to reimbursement, and requirements for supervision and collaboration may occur. Regulations that affect nursing practice may be implemented by a variety of agencies. Knowing which agencies regulate health care, healthcare delivery systems, and professional practice, and monitoring legislation and regulations proposed by those agencies, is important for safeguarding practice. Chief among the agencies that should be tracked are the health professions licensing boards, state agencies that govern licensing and certification of healthcare facilities, agencies that administer public health services (e.g., public health, mental health, and alcohol and drug agencies), and agencies that govern federal/state contribution program reimbursement (e.g., Medicare and Medicaid). EXHIBIT 4-1 Questions to Ask When Analyzing Regulations Which agency promulgated the regulation? What is the source of the agency’s authority (the law that provides the agency’s rule-making authority)? What is the intent or rationale of the regulation, and is it clearly stated? How does the regulation affect the practice of nursing? Does it constrain or limit practice? Is the language in the regulation clear or ambiguous? Can the regulation be interpreted in different ways? Discuss the advantages of language that is clear versus ambiguous. Are there definitions to clarify terms? Are any important points omitted? Is there sufficient lead time to comply with the regulation? What is the fiscal impact of the regulation? In particular, APRNs should be aware of regulations that mandate benefits or reimbursement policies and lobby for their inclusion as potential recipients of these benefits or funds. Several states have instituted open-panel legislation, known as “any willing provider” and “freedom of choice” laws. These bills mandate that any provider who is authorized to provide the services covered in an insurance plan must be recognized and reimbursed by the plan. Conversely, insurance companies and business lobbyists oppose this type of legislation. As managed care contracts are negotiated, APRNs must ensure their services are given fair and equitable consideration. Other important areas for nurses include worker’s compensation participation and liability insurance laws. In summary, agencies that may potentially promulgate regulations that could have implications for APRN and RN practice or reimbursement should be monitored. Exhibit 4-1 provides some key questions to consider when analyzing a regulation for its impact on nursing practice. Serving on Boards and Commissions One way to actively participate in the regulatory process is to seek appointment to the state BON or to other health-related boards or commissions. Appointments to boards and commissions should be sought strategically. It is important to select an agency with a mission and purpose consistent with your own interests and expertise. Because most board appointments are gubernatorial or political appointments, it is important to obtain endorsements from legislators, influential community leaders, and professional associations. Individuals seeking appointment are more likely to acquire endorsements if they have an established history of service to the professional community. Letters of support should document the appointment candidate’s primary area of practice and contributions to professional and community service. Delineate involvement in local, state, and national organizations. A letter from the employer is recommended, as both an indication of the employer’s willingness to support time away from work to fulfill the responsibilities of the position during the term of office and as an endorsement of the candidate’s professional merit. A personal letter from the appointment candidate should include the rationale for volunteering to serve on the particular board or commission, evidence of a good match between the individual’s expertise and the board or commission purpose, and expression of clear interest in public service. A specific application form may be required (often found on the governor’s website), and a résumé or curriculum vitae should be attached. Appointment decisions take into account the individual’s potential contributions to the work of the board or commission. This kind of public service requires a substantial time commitment, so it is wise to speak to other board members or the executive director/agency administrator to determine the extent of that commitment.