NURS 4

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CHAPTER4GovernmentResponse1.docx

CHAPTER 4 Government Response: Regulation

Jacqueline M. Loversidge

KEY TERMS:

Administrative procedures act (APA): A state or federal law that establishes rule-making procedures for its respective agencies. Board of nursing (BON): An executive-branch state government administrative agency charged with the power and duty to enforce laws and regulations governing the practice of nursing in the interest of public protection. Certification: A form of voluntary credentialing that denotes validation of competency in a specialty area, with permission to use a title. Licensure: A form of credentialing whereby permission is granted by a legal authority to perform an act that would, without such permission, be illegal, a trespass, a tort, or otherwise not allowable. Multistate regulation: A provision that allows a professional to practice in more than one state based on a single license. National Council of State Boards of Nursing (NCSBN): A not-for-profit, nongovernmental organization that provides a means by which state boards of nursing may discuss and act on matters of common interest, including development of licensing examinations. PICOT: An acronym that serves as a format or template to identify elements of or ask a health policy question. The letters stand for Population, Intervention, Comparison, Outcomes, Time. Public rule hearings: Meetings held by state or federal administrative agencies for the purpose of receiving testimony from witnesses who support or oppose regulations or to receive expert testimony. Practice act: A law that regulates and defines legal responsibilities of the nurse and scope of practice. It is intended to protect the public from harm as a result of unsafe or unqualified nurses. Recognition: A form of credentialing that denotes a government authority has ratified or confirmed an individual’s credentials. Registration: A form of credentialing that denotes enrolling or recording the name of a qualified individual on an official agency or government roster. Regulations (rules): Orders or directives that provide details or procedures to operationalize a federal or state law (statute). A law directs an agency or government to develop and implement regulations/rules to achieve the purpose(s) of that law. Rules have the force and effect of law.

▶ Introduction

Regulation of the U.S. healthcare delivery system and of healthcare providers exists to protect the interests of public safety, but regulatory structures are extraordinarily complex. The vastness of the industry, the manner of healthcare financing, and the proliferation of laws and regulations that govern practice and reimbursement contribute to that complexity.

This chapter focuses on major concepts associated with the regulation of healthcare professionals. Understanding licensure and credentialing processes and their impact on nursing is essential. Understanding how regulations affect the healthcare system and individual providers empowers nurses and other providers to advocate on behalf of the profession and consumers.

All healthcare professionals are licensed by state government agencies. Practice-specific boards or commissions (e.g., the Ohio Board of Nursing) or multiprofessional boards (e.g., Michigan’s Department of Licensing and Regulatory Affairs) are executive-branch regulatory agencies that govern each profession with the goal of protecting the public. State practice-specific board processes are similar from state to state but vary to some extent because their laws are determined by individual state legislatures, and their regulations are determined by the specific agency.

Regulation Versus Legislation

The legislative and regulatory processes operate in parallel. Both are public processes and equally powerful; however, their processes differ in important ways. Legislation is shaped by elected lawmakers—for example, state legislators or members of the U.S. Congress. Laws are written in general terms to assure applicability over time and to establish public policy. Regulations emerge from the law’s rule-making authority and shape details of implementation.

The legislative process is the first step in this two-layer process. Lawmakers introduce bills and shepherd them through the complex legislative process. The process begins when one or more (usually not more than two) legislators from the same house sponsor introduction of a bill during a legislative or congressional session. Bills may address issues of interest to the sponsoring legislator or of concern to the sponsor’s constituents. Bills can be amended, substituted, or “die” at any number of points during the session. Checks and balances are built into the process; bills must be scrutinized by both houses and successfully navigate through committees during which testimony is heard. If they are passed by both houses and signed by the president or governor, they are enacted (“enrolled”) and become law. Bills must pass during the session in which they are introduced; otherwise, they “die,” with the docket for that congressional session or state general assembly being cleared, and the bill must be reintroduced in a subsequent session.

The terms legislation, act, law, and statute are synonyms. Legislation also refers to both a bill-in-progress and a law that has been enacted. When referring to laws regulating professions, the term practice act is used.

Once signed into law, statute implementation is generally the responsibility of an administrative agency. Administrative agencies execute their responsibilities by enforcing both law and regulations. Regulations (rules) enable reasonable implementation of the law. Note the terms regulation and rule are also used interchangeably. Whereas law is written in broad language, regulations are detailed and specify how the law will be put into practice. An administrative agency’s authority to write and implement regulations is established in the laws that create the agency.

Example: Nurse practice acts (NPAs) generally require the board of nursing (BON) to write rules with criteria that applicants must meet to be eligible to sit for licensure examinations and for issuing licenses. Rules amplifying that provision of law include specific eligibility criteria and application procedures, designate approved examinations (e.g., NCLEX for registered nurses [RNs] and licensed practical nurses [LPNs] or national certifying examinations for APRNs), and include renewal procedures and fees.

The regulatory and legislative processes differ in other ways. Rule making is not dependent on legislative session schedules, so rules may be promulgated (written) at any time by an administrative agency. Also, regulations adhere to administrative procedures act (APA) requirements; some states require evaluation and revision of regulations on a predictable schedule to assure regulations reflect the current environment.

Like lawmaking, regulation promulgation is a public process and is described in greater detail later in this chapter. The rule-making process, like lawmaking, also includes structures to assure checks and balances. For example, a nonbiased government body, such as Ohio’s legislative Joint Committee on Agency Rule Review (JCARR), may be charged with oversight; it reviews all administrative regulations to assure that (1) the filing administrative agency does not exceed its statutory authority and (2) proposed regulations do not encroach on other laws or regulations.

If an administrative agency finds its regulations are inadequate to serve the needs of the public, and if the law does not support the additional rule-making authority it needs, it may seek statutory modification to add a section in the law that allows additional rule-making authority. To do so requires the agency to seek law change through the full legislative process. For nursing, this may include what is known as opening the nurse practice act.

Both laws and regulations have the same force and effect of law. Therefore, even though regulations are written by a government agency rather than a legislative body, regulations carry great weight because their origin stems from the law that provided the agency with its rule-making authority.

From here forward, the term law will be used instead of legislation, but regulation and rule will be used interchangeably. There are uses for which the term rule is preferable (e.g., rule-making authority).