NURS 4

The Federal Regulatory Process

The federal government has become a central factor in health professions regulation. A number of forces have influenced this trend; however, the advent of the Medicare and Medicaid programs was especially significant. Federal initiatives that have grown from these programs include cost containment (prospective payment), consumer protection (combating fraud and abuse) (Jost, 1997; Roberts & Clyde, 1993), and the initiatives and programs written into the Patient Protection and Affordable Care Act (ACA) and the Health Care and Education Reconciliation Act of 2010 (U.S. Department of Health and Human Services [DHHS], 2014). In July 2001, the Centers for Medicare and Medicaid Services (CMS) replaced the former Health Care Financing Administration (HCFA). As a result of its reformulation, this agency now provides increased emphasis on responsiveness to beneficiaries, providers, and quality improvement. Three business centers were established as part of the reform: Center for Beneficiary Choices, Center for Medicare Management, and Center for Medicaid and State Operations (CMS, 2014). In 2003, President George W. Bush signed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) into law. The act created a prescription drug benefit for Medicare beneficiaries and established the Medicare Advantage program (O’Sullivan, Chaikind, Tilson, Boulanger, & Morgan, 2004), effectively providing seniors with prescription drug benefits and more choice in accessing health care. As the Medicare program has evolved, the practice of APRNs has likewise been influenced by changes in Medicare reimbursement policy. In 1998, when Medicare reimbursement reform was enacted, APRNs won the right to be directly reimbursed for provision of Medicare Part B services that, until that time, had been provided only by physicians. In addition, the reform lifted the geographic location restrictions that had limited patient access to APRNs. More recent revisions to the required qualifications, coverage criteria, billing, and payment for Medicare services provided by APRNs are specific, depending on whether the APRN is a certified registered nurse anesthetist (CRNA), nurse practitioner (NP), certified nurse‒midwife (CNM), or clinical nurse specialist (CNS). Reimbursement for APRNs has generally improved; for example, NP services are now paid at 80% of the lesser of the actual charge or 85% of the fee schedule amount a physician is paid (U.S. DHHS, CMS, 2016). However, APRNs continue to lobby for reimbursement at 100% of the amount paid to physicians. Relationships between the state and federal regulatory systems are highly dynamic. Responsibilities once assumed by the federal government have been shifted to the state level; administration and management of the Medicaid and welfare programs are examples. The perspective that states are better equipped to make decisions about how best to assist their citizens, coupled with a public sentiment that generally seeks to diminish federal bureaucracy and its accompanying tax burden, have been instrumental in moving the placement of authority to the states. However, although states have primary authority over regulation of the health professions, federal policies continue to have a significant effect on healthcare workforce regulation. For example, policies related to reimbursement and quality control over the Medicare and Medicaid programs are promulgated by the U.S. Department of Health and Human Services and administered through its financing agency, CMS. The Veterans Health Administration, the Indian Health Service, and the uniformed armed services are also regulated by the federal government. Large numbers of health professionals, many of whom are nurses/APRNs, are employed by these federal agencies and departments. Federally employed health professionals must be licensed in at least one state/jurisdiction. These individuals are subject to the laws of the state in which they are licensed and the policies established by the federal system in which they are employed. However, the state of licensure need not correspond with the state in which the federal agency or department resides, because practice that occurs on federal property is not subject to state oversight. This status reflects the fact that the Supremacy Clause of the U.S. Constitution, Article VI, Paragraph 2, establishes that federal laws generally take precedence over state laws (Legal Information Institute, n.d.). State laws in conflict with federal laws cannot be enforced. The Commerce Clause of the U.S. Constitution limits the ability of states to erect barriers to interstate trade (Gobis, 1997). Courts have determined that the provision of health care constitutes interstate trade under antitrust laws, which in turn sets the stage for the federal government to preempt state licensing laws regarding the practice of professions across state boundaries if future circumstances make this a desirable outcome for the nation. The impact of technology on the delivery of health care—for example, telehealth—allows providers to care for patients in remote environments and across the geopolitical boundaries defined by traditional state-by-state licensure. This raises the question as to whether the federal government would have an interest in interceding in the standardization of state licensing requirements to facilitate interstate commerce. If this occurred, the federal government would be in the position of usurping what is presently the state’s authority. Licensing boards have an interest in avoiding federal intervention and are beginning to identify ways to facilitate the practice of telehealth while simultaneously preserving the power and right of the state to protect its citizens by regulating health professions at the state level. One approach to nursing regulation that addresses this conundrum is multistate regulation, which is discussed later in this chapter. Federal Rule Making The federal regulatory process is established by the federal administrative procedures act. In this process, a Notice of Proposed Rulemaking (NPRM) is published in the Federal Register, a public, daily federal government publication containing current executive orders, presidential proclamations, rules and regulations, proposed rules, notices, and sunshine act meetings. The NPRM includes information about the substance of intended regulations and information about public participation in the regulatory process, including procedures for attending meetings or hearings and for providing comment. The agency writing the rules is mandated to consider all public comments, and amendments to draft regulations may be made based on public input if warranted. The agency publishes final regulations in the rules and regulations section of the Federal Register. Rules become effective 30 days after they are filed in final form by the agency and published in the

Federal Register (FIGURE 4-1).

FIGURE 4-1 The federal rule-making process. Reproduced from Carey, M. P. (2013, June 17).

The federal rulemaking process: An overview. Congressional Research Service Report RL32240. Retrieved from http://www.fas.org/sgp/crs/misc/RL32240.pdf Emergency Regulations Provisions for promulgating emergency regulations are defined at both the state and the federal levels. Emergency regulations are enacted if an agency determines that the public welfare is in jeopardy and the regulation will serve as an immediately enforceable remedy. Emergency regulations usually take effect upon their date of publication, are generally temporary, and are effective for a limited time period (usually 90 days), with an option to renew them. Emergency regulations must be followed with permanent regulations that are promulgated in accordance with the usual APA requirements. Locating Information Each state government periodically publishes a document containing notices, proposed regulations, final regulations, and emergency regulations. The publication cycle for this document—usually called the State Register or State Bulletin—can be obtained by accessing the state legislative printing office/website or the state legislative information system office/website. Federal regulatory information is available online: the National Archives manages the Code of Federal Regulations (CFR) website and the U.S. Government Publishing Office oversees the eCFR website. Because state and federal agencies promulgate numerous regulations, it is in one’s best interest to belong to at least one national professional organization, most of which employ professional lobbyists who track legislation, monitor agencies’ rule making, and report to their membership. Some state organizations employ such lobbyists; many others do not have the financial resources to do so. Specialty organizations’ newsletters and journals and legislative subscription and monitoring services and bulletins can be relied upon to summarize proposed regulation content and track status progress. Providing Public Comment Regulatory agencies provide a small window of opportunity for public comment. Most comment periods last 30 days from the date of publication of the proposed regulation. However, longer comment periods are sometimes permitted if the agency anticipates the issue will draw strong public interest or involves controversy. Public rule hearings are held by the agency proposing the regulation. Public agencies must comply with administrative procedures act regulations regarding public hearings. Federal agencies are generally required to hold hearings when a numeric threshold is reached (i.e., a certain number of individuals or agency/organization representatives make requests to offer testimony). Written comments received by the agency are made a part of the permanent record and must be considered by the agency’s board or commission members prior to publication of the final regulation. A final regulation can be challenged in the courts if the judge determines the agency did not comply with the administrative procedures act or ignored public comments. The Federal Register provides agency contact information on its website, making it feasible for the public to provide comment on proposed regulations. Only written comments are included in the public record, although agencies may permit oral comments if time is short. Instructions for submitting electronic comments or written submissions by mail, hand delivery, or courier are generally included on the filing agency’s Federal Register webpage. Comments received after the comment period posted in the Federal Register is closed can be legitimately disregarded by the agency. Strengths and Weaknesses of the Regulatory Process The regulatory process is somewhat more well ordered than the legislative process in that it is directed by state or federal administrative procedures acts. These procedures guarantee opportunities for comment and public input. The regulatory process also includes built-in delays and time constraints that slow the process of developing and implementing regulations. However, administrative agencies are able to exert a great deal of control over the rule-drafting process. Agency staff have an interest in assuring the final regulation has sufficient detail that it can be reasonably enforced. It is possible that agency staff, although skilled regulators, may not be knowledgeable about a regulation’s impact from the practitioners’ point of view. If the agency did not invite stakeholders to assist with the original drafting of the regulation, then public input during the comment period is especially important. In addition to enforcement, administrative agencies may have legislative authority to interpret regulations. Sometimes regulations may be misinterpreted by agency staff or board members, resulting in the imposition of a new meaning that is not aligned with the original intent of the regulation. These interpretations may be published as opinions, interpretive statements, and/or declaratory rulings of the board. Opinions of the attorney general or court may also misinterpret the original legislative intent, but the judicial branch of government is more likely to apply sound legal standards to its fact-finding and conclusions of law. Regardless, official opinions carry the force and effect of law even if they are not promulgated as regulations, according to the administrative procedures act. Regulation in a Transforming Healthcare Delivery System In the United States, the healthcare delivery system is undergoing a period of significant and rapid change. Evidence of system shifts began in 1995, when the Pew Health Professions Commission (1994) published a sweeping report that stimulated new thinking about existing regulatory systems. The report suggested that the system, based on a century-old model structured with separate health professions agencies regulating individual health professionals with potentially overlapping scopes of practice, was out of sync with the nation’s healthcare delivery systems and financing structures. The Pew Health Professions Commission suggested that major reform was needed and asked states to review regulatory processes with the following questions in mind (Dower & Finocchio, 1995, p. 1): Does regulation promote effective health outcomes and protect the public from harm? Are regulatory bodies truly accountable to the public? Does regulation respect consumers’ rights to choose their own healthcare providers from a range of safe options? Does regulation encourage a flexible, rational, and cost-effective healthcare system? Does regulation allow effective working relationships among healthcare providers? Does regulation promote equity among providers of equal skill? Does regulation facilitate professional and geographic mobility of competent providers? The Pew Task Force on Health Care Workforce Regulation challenged state and federal governments to respond to the complex health professions education and regulation issues identified in the report. Report recommendations addressed the use of standardized and understandable language, standardization of entry-to-practice requirements, assurance of initial and continuing competence of healthcare practitioners, and redesign of professional boards, including creation of super-boards in which the majority of members are consumer representatives. The report also called for better methods of assessing the achievement of objectives and improved disciplinary processes (Pew Health Professions Commission, 1995). Some of these changes have already been implemented in regulatory agency structures, such as standardization of entry-to-practice requirements, but redesign of professional boards has been slow to change. Following the 1995 Pew report, the Institute of Medicine (IOM)—now known as the National Academy of Medicine—issued a number of reports related to safety in healthcare systems, known as the Quality Chasm Series. Several of these reports made recommendations with regard to regulation. For example, in its first report, To Err Is Human, the IOM called for licensing and certification bodies to pay greater attention to safety-related performance standards and expectations for health professionals (Kohn, Corrigan, & Donaldson, 2000). A consensus report, focused singularly on nursing, was jointly issued by the Robert Wood Johnson Foundation and the IOM in October 2010. This report, which bore the title The Future of Nursing: Leading Change, Advancing Health, provided four key messages to guide changes and remove barriers that prevent nurses from being able to function effectively in a rapidly evolving healthcare system: Nurses should be enabled to practice to the full extent of their education and training. Nurses should be able to access higher levels of education and training in an improved education system that allows for academic progression. Nurses should be full partners in the interprofessional redesign of the U.S. healthcare system. Effective workforce planning and policymaking need better data collection and information infrastructures. Eight recommendations for fundamental change are found in the report, along with related actions for Congress, state legislatures, CMS, the Office of Personnel Management, the Federal Trade Commission, and the Antitrust Division of the Department of Justice. The recommendation most relevant to regulation is the first: to remove scope-of-practice barriers. Other recommendations with implications for regulation include the call to prepare and enable nurses to lead change to advance health—that is, nurses who serve on boards and commissions serve in such roles—and the suggestion to build an infrastructure for the collection and analysis of interprofessional healthcare workforce data (IOM, 2010). Regulatory boards often survey their licensees as a part of renewal, providing excellent sources of workforce data. Some progress toward accomplishment of the Future of Nursing report recommendations has been made, but, importantly, barriers to expansion of APRN scopes of practice remain (IOM, 2016). Another area ripe for regulatory reform relates to structures that encourage interprofessional collaboration. The Josiah Macy Jr. Foundation, an organization dedicated to improving the health of the public through the advancement of health professions education, has been instrumental in providing direction for regulatory reform. In 2013, this foundation held a consensus conference with health professions education leaders to discuss a vision for a joint future of healthcare practice and education. Recommendations for action in five areas were made; one of these was to “revise professional regulatory standards and practices to permit and promote innovation in interprofessional education and collaborative practice” (Josiah Macy Jr. Foundation, 2013, p. 2). Together these reports and recommendations provide a substantive body of evidence that can be leveraged for health professions regulation reform, thereby ensuring these professions can meet the needs of 21st-century healthcare consumers. APRNs have a window of opportunity to act on these recommendations but must be open to the notion that collaboration with other health professions is essential if new regulatory models are to emerge. Regulation determines who has access to the patient, who serves as gatekeeper in a managed care environment, who is reimbursed, and who has autonomy to practice. APRNs must be visible participants in the political process that authorizes APRNs to practice to the full extent of their education in a collaborative environment as equal team members and ensures consumer choice and protection.