Medical Board Exposure to Threats of Violence
Transcription
Medical Board Exposure to Threats of Violence
JMR Jo urn a l of me dic a l r e gu l at ion CRITICAL THINKING ON ISSUES OF MEDICAL LICENSURE AND DISCIPLINE VOLUME 99 NUMBER 3 2013 Medical Board Exposure to Threats of Violence What Boards Are Doing to Ensure Security C E L✺ E B✺ R A T✺ I N G✺100 YEARS ✺✺ ✺ ✺✺ ✺ ✺O F CONTINUOUS PUBLICATION ✺ ALSO IN THIS ISSUE Maine Launches Informed Consent Guidelines Legal Briefs: Analysis of FTC’s Court Victory in North Carolina THE JOURNAL OF MEDICAL REGULATION BEGAN CONTINUOUS PUBLICATION AS THE QUARTERLY OF THE FEDERATION OF STATE MEDICAL BOARDS IN 1913. OVER THE YEARS IT HAS BEEN PUBLISHED IN VARIOUS FORMATS AND WITH DIFFERENT NAMES — ALWAYS OFFERING INSIGHTFUL COMMENTARY AND IMPORTANT NEWS AND STUDIES OF INTEREST TO MEDICAL REGULATORS. TODAY THE JOURNAL REACHES THOUSANDS OF POLICY MAKERS, ACADEMICS AND LEADERS IN THE REGULATORY COMMUNITY. JMR Submit a manuscript to the Journal of Medical Regulation For more information about how to submit a manuscript, please see Information for Authors on page 31. me dic al re gul ation Journal of VO L U M E 9 9 , N U M B E R 3 , 2 0 1 3 2 Publisher’s Information .................................... 3 Quoted | Note from the Editor .................................... 4 News & Notes .................................... 5 Message from the Chair .................................... 8 Past and Present .................................... I N T H E FAC E O F T H R E AT S , w hat steps do boards take to ensure safet y ? 11 State Medical Board Exposure to Threats of Violence: A Survey by the FSMB Foundation Kelly C. Alfred, MS Timothy Turner, BBA Aaron Young, PhD .................................... 18 Obtaining Meaningful Informed Consent: Guidelines from the Maine Board of Licensure in Medicine David Nyberg, PhD 22 Legal Briefs 25 State Member Board Briefs 30 International Briefs 31 Information for Authors “…less than half of the respondents are satisfied with their present security level…” From the article “State Medical Board Exposure to Threats of Violence: A Survey by the FSMB Foundation,” page 11. JMR Journal of medical reg ul ation Published Since 1913 | VOLUME 99, Number 3, 2013 All articles published, including editorials, letters and book reviews, represent the opinions of the authors and do not necessarily reflect the official policy of the Federation of State Medical Boards (FSMB) of the United States Inc. or the institutions or organizations with which the authors are affiliated unless clearly specified. Editor-in-Chief Ruth Horowitz, PhD Editorial Committee Carl F. Ameringer, PhD, JD Mohammed Arsiwala, MD Larry J. Berg, JD Mark Bowden FSMB Officers Subscriptions and Correspondence Chair: Jon V. Thomas, MD, MBA Subscribe online at: jmr.fsmb.org Chair-elect: Donald H. Polk, DO Subscriptions and correspondence about subscriptions should be addressed to the Journal of Medical Regulation, 400 Fuller Wiser Rd., Suite 300, Euless, TX 76039. Treasurer: Galicano F. Inguito Jr., MD, MBA President/Chief Executive Officer: Humayun J. Chaudhry, DO, MS, MACP John W. Graves, JD Immediate Past Chair: Lance A. Talmage, MD Rebecca J. Hafner-Fogarty, MD, MBA FSMB Board of Directors Michael K. Helmer Hedy L. Chang, MS Patricia King, MD, PhD Linda Gage-White, MD, PhD, MBA Sindy M. Paul, MD, MPH J. Daniel Gifford, MD Wayne Reynolds, DO Arthur S. Hengerer, MD Leticia J. San Diego, PhD Stephen E. Heretick, JD E. Scott Sills, MD, PhD Lyle R. Kelsey, MBA Cheryl Graham Solomon, MA Editor Emeritus Dale G Breaden Ralph C. Loomis, MD Blake T. Maresh, MPA Gregory B. Snyder, MD Datta G. Wagle, MD Michael D. Zanolli, MD © Copyright 2013 The Federation of State Medical Boards of the United States Inc. FSMB Executive Staff President/Chief Executive Officer: Humayun J. Chaudhry, DO, MS, MACP The Journal of Medical Regulation (ISSN 1547-48IX, publication number 189-120) is published quarterly by the Federation of State Medical Boards of the United States Inc., 400 Fuller Wiser Rd., Suite 300, Euless, TX 76039. Telephone: (817) 868-4000 Fax: (817) 868-4098 Postmaster: Send address changes to the Journal of Medical Regulation 400 Fuller Wiser Rd., Suite 300, Euless, TX 76039. Periodicals postage paid at Euless, Texas, and additional mailing offices. Subscriptions for individuals are $70 per year; single copies are $18 each. Subscriptions for libraries and institutions are $140 per year; single copies are $36 each. Notification of change of address should be made at least six weeks in advance. Enclose new and old addresses, including ZIP code. 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Sympathy comes, in the human form, in the arousing in one’s self of the attitude of the individual whom one is assisting.1 — George Herbert Mead George Herbert Mead, a social philosopher at the University of Chicago (1863–1931) and father and grandfather of physicians, saw the need for each person to place him or herself “in the attitude” of the individual with whom he or she seeks cooperation. For medical board staff and members this means thinking hard about each other’s perspectives, and especially about taking into account the patients’ interests in the decision-making process. How will board actions be understood and affect diverse groups of patients? The articles assembled in this issue explore several contentious problems highlighting patients’ needs. One recent legal case discussed here involves a dental board controversy over scope of practice (page 22). This case underscores the need to balance two goals that can work at cross-purposes: patient safety and access to care. The problem is familiar and is certain to affect practitioners in every field. Federal licensure is another controversial matter raised in this issue (page 8). It concerns the diversity of standards of entry and practice across the states. A third selection focuses on Maine’s efforts to ensure that patients fully understand the provisions of informed consent (page 18). Such efforts require physicians speaking with, rather than to, the patient, “taking the attitude of the other” before the signature on the consent form is obtained. We are also reminded that we must look at the fears of boards and staff as they go about their work in the sometimes contentious world of board work in our fourth contribution — an article about threats of violence against state medical boards (page 11). In all of these examples, we see illustrated the imperative to learn from all sides, especially the viewpoint of patients, and to promote cooperation between the stakeholders in decision making. As I begin my tenure as JMR’s new editor-in-chief, you can be assured this imperative will continue to be at the forefront of our journal. Ruth Horowitz, PhD Editor-in-Chief 1 Mead, G. H. (1934/1962) Mind, Self and Society edited by C.H. Morris. Chicago, University of Chicago Press (p.299) J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 3 N E W S & N OT E S FSMB and Several Partners Launch Data Commons, LLC Safe and Competent Opioid Prescribing Program Established The FSMB and several other leading national physician education and assessment organizations have launched Data Commons, LLC. Data Commons is an information-sharing company that is developing a system to improve the accessibility and use of data about physicians and other health care professionals. The Boston University School of Medicine, the Council of Medical Specialty Societies and the FSMB have collaborated to create the SCOPE of Pain program, intended to provide free, online education to help educate prescribers in the safe use of opioids. The core of the new system is a secure data hub that allows multiple organizations to make available selected information from their individual databases. The system makes it possible for researchers, analysts and other data users to acquire information from multiple databases in a single transaction and at lowered cost. Data Commons LLC partners include the American Board of Family Medicine, American Board of Pediatrics, Association of American Medical Colleges®, Educational Commission for Foreign Medical Graduates, Federation of State Medical Boards and National Board of Medical Examiners®. For more information, visit www.mydatacommons.com. Board Attorneys Workshop Scheduled for November A special educational workshop for state medical board attorneys and legal staff will be hosted by the FSMB on November 7–8 in Portland, Oregon. The two-day conference will be held at the Hilton Portland & Executive Tower, situated in the heart of downtown Portland. Participants at the annual Board Attorneys Workshop will have the opportunity to share and exchange information on case experiences, best practices and current issues pertinent to boards attorneys. Among other topics, the workshop will help participants identify and discuss dynamics and legal issues that may influence how medical boards discipline physicians, develop strategies used by boards to help protect the public and investigate options for improving state board performance and effectiveness. To learn more, visit www.fsmb.org or call 817-868-4007. 4 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 The SCOPE (Safe and Competent Opioid Prescribing Education) program addresses many key elements of the physician component of the Obama Administration’s prescription drug abuse prevention plan on prescriber education. The first phase of the SCOPE program includes a free series of three educational modules that have been accredited for a maximum of 3.0 AMA PRA Category 1 Credits. The program may satisfy risk management and opioid education CME requirements in many states. To learn more, visit www.scopeofpain.com. Summary of First Tri-Regulator Symposium Available Online “Protecting Patients and the Public: A Heritage of Excellence,” a summary of the First Tri-Regulator Symposium, hosted late last year in Washington, D.C., is now available to the public online at the FSMB website. The publication summarizes the proceedings of discussions between the FSMB, the National Association of Boards of Pharmacy (NABP) and the National Council of State Boards of Nursing (NCSBN), during the first formal meeting of the three groups, known as the Tri-Regulator Collaborative. During the two-day symposium, a diverse group of speakers and panelists discussed topics ranging from the U.S. opioid crisis to the growing use of social media by physicians and nurses. Additional sessions focused on new trends in assessing the competency of physicians, nurses and pharmacists, and projections of U.S. health care workforce needs for the future. “Protecting Patients and the Public: A Heritage of Excellence” is available at www.fsmb.org/pub_ publications.html. n Message from the Chair In the Midst of Great Challenge in Health Care, State Regulators Can Make a Difference Jon V. Thomas, MD, MBA Chair, Board of Directors Federation of State Medical Boards I N B R I E F Dr. Thomas highlights three areas in the challenging U.S. health care environment in which the leadership of state regulators is needed As I begin my year as the Chair of the FSMB, I find myself reflecting on both the challenges and worrisome trends in health care — and at the same time, the many opportunities we find before us. This is a time for leadership, and I believe the medical regulatory community can help the nation address its challenges in several key areas — which I will describe in a moment. Simply put, the nation needs us. We’ve never experienced an era of health care quite so fraught with difficulties and emerging problems. Of the 14 member countries of the Organisation for Economic Co-operation and Development, the United States spends the most for its health care system. In fact, some experts cite a figure 10 times greater than the expenditures of other developed countries. Many lament our World Health Organization (WHO) ranking with regards to life expectancy and infant mortality. When compared to other economically developed nations, we are ranked last. In almost every talk I have heard over the last year on the Simply put, the nation needs us. We ’ ve never e x perienced an era of health care q uite so fraught w ith difficulties and emerging problems. economics of health care, every speaker juxtaposed the cost of the U.S. health care system with our WHO ranking and implied that the United States has the worst and most expensive health care system in the world. In fairness, the picture isn’t quite so black and white — there are many other reasons for our poor showing in global comparisons. For example, recent studies have found that the major cause of death below the age of 50 in the United States is unintentional injuries, including drug overdose. This distorts life expectancy. As state regulators well know, we have experienced a rise in deaths due to opiate overdose. In a similar vein, in vitro fertilization and aggressive intervention in early pre-term preg nancies negatively influences our infant mortality data. But the bottom line is that the cost of our system is too high and the relationship between cost and health outcomes has become imbalanced. Beyond this, the U.S. health care system is undergoing other challenges that are unsustainable. The demographic bulge of baby boomers hitting the Medicare rolls has already begun to burden our system. For every dollar that is contributed to Medicare, the enrollee receives many more dollars of Medicare services in return. This is unsustainable. Soon, as a result of the Affordable Care Act, millions of new patients will be added to a health care system that on many levels is not wholly prepared to absorb them. This, coupled with reduced funding for residency programs, has the potential to exacerbate what many believe are real shortages in key specialties. While all of this is happening, we’re also in the midst of fast-moving technological change. As we progress through what many are calling the third Industrial Revolution, digital technologies have disrupted many industries and will continue to do so. With the advent of networking, we are starting to see the true impact of the technological revolution. Networking is the ability of individuals to come together and exchange information. The network is the key. The ability to connect is where power lies. The impact of networking on health care is just beginning, as motivated patients want immediate answers to their medical problems. They want it faster, cheaper and J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 5 better. Increasingly, patients are becoming more adept at diagnosing themselves: As an example, two young patients of mine recently correctly diagnosed their medical problems using technology. In the modern era we have defined health care effectiveness as delivering the right care, at the right time and in the right place. For patients, the right place is where they are at the moment, and the right time is now. Increasingly, motivated patients with networked computers have access to sources of information and expertise that were unheard of 10 years ago and they will seek out access to a specialist regardless of location. These two factors — enormous challenge in health care and a fast-evolving technology environment — are setting the stage, I believe, for our work as regulators. We have the opportunity to sort out the many questions we are faced with — through leadership. If society is becoming increasingly networked, then it is incumbent upon state medical boards to do the same. We must facilitate and expedite the transfer of information to make expeditious licensing and …having a minimum data set would give policy makers, the public and market participants the information the y need to make informed decisions . disciplinary decisions. Where we can, we need to develop common language and processes. Our challenge will be to create a truly modern medical licensing system by the states and territories, for the states and territories. By doing so, we will be effectively positioned to help the nation respond to its overall health care challenges. where and how he or she is practicing. Working with state medical boards and the U.S. Health Resources and Services Administration, we have developed a minimum data set (MDS) to help us expand our knowledge and understanding of the physician workforce. The MDS would include several key pieces of information, ranging from practice location to specialty training, which every physician would provide during the license renewal process. As we anticipate expanding Medicare rolls and a significant increase of those with insurance as a result of the Affordable Care Act, we will need better information to inform our decisions around workforce needs. Reduced Graduate Medical Education (GME) funding and the potential for reduced residency positions may further complicate our national physician workforce picture. We recognize that having a minimum data set would give policy makers, the public and market participants the information they need to make informed decisions. My hope is that the minimum data set, provided by our member state medical boards and residing in the FSMB’s Physician Data Center, will lead to better forecasting. Maintenance of Licensure (MOL). One of the most pressing concerns in our current health care environment is the need to focus on patient outcomes and improved quality of care. Continuous professional development has come to be accepted as an integral part of the continuum of medical education, from medical school to the end of a career. MOL is a process of continuous professional development and life-long learning that we believe will help us move more quickly on the road toward continuous quality improvement in health care. Let me discuss each briefly. The FSMB is working with sister organizations and several state medical boards to develop the concept of MOL, including exploring the key question of what activities would count towards successful MOL fulfillment, and we are making great progress. One of our key concepts is that physicians shouldn’t be required to take a high-stakes exam to fulfill MOL, but should be able to choose from the variety of professional development activities they may already be engaged in. Physician Workforce. The FSMB recently published its second census of U.S. physicians. We now know that we have more than 870,000 licensed physicians in the United States. While this is useful information, it is incomplete and doesn’t tell the complete picture. We don’t know if a licensee is practicing, for example, or My own story is a great example of how the MOL concept could work. I am a busy physician in a large private single specialty group practice and not particularly interested in taking a high-stakes exam. I am boardcertified, but with a time-unlimited certificate. What I would personally like to have is a practice-specific I’d like to suggest three areas where I believe we can make a real difference — and which I’ll focus on during my year as FSMB Chair. They are: physician workforce, Maintenance of Licensure, and eHealth. I believe by concentrating our efforts in these three areas, we will have the broadest impact on medical boards, physicians and patients. 6 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 assessment, informed by data in my Electronic Health Record system, and produced by organizations with expertise in assessment. Reviewing the results of my assessment — which would examine my patient outcomes and practice patterns — would then determine my practice gaps, or areas I need to improve upon. My practice gaps would then determine the Continuing Medical Education (CME) activities I would pursue. Successful completion of appropriately accredited CME activities would help me reach a standard of competence and/or excellence set by organizations with expertise in standards. This kind of targeted approach would ensure that my continuing professional development activities are truly helping me improve as a physician. The scenario I described is just one example of the myriad ways in which participation in MOL could occur, and it demonstrates the general approach to targeted MOL that should be explored. To help move the process along, I have formed a workgroup that is helping identify the types of activities that could satisfy MOL. eHealth. As the Affordable Care Act is implemented, as demographic changes occur in the United States and as technology continues to evolve, the concept of eHealth will be increasingly on the radar of state medical boards. Our health care system is naturally moving towards new uses of technology — which must be carefully monitored to ensure they maintain patient safety as they improve our efficiency. Since its existence, the FSMB has always been a champion of license portability — that is, ensuring that the process of obtaining a license is not cumbersome as a physician moves through his or her career, sometimes moving from state to state. The widespread use of technology by both patients and physicians has created a new context for the concept of portability — as has the anticipated influx of millions of new patients into the system as a result of the Affordable Care Act. Access to care will be critically important in coming years, especially in rural and underserved areas. And all of this means licenses must be increasingly portable. The FSMB has taken its historical efforts to improve portability to a new level with its recent decision to explore creation of an interstate compact for medical licensure — which would increase efficiency in the licensing of physicians who practice in multiple states. In April, the FSMB House of Delegates formally commissioned this initiative, and the FSMB has hosted two meetings to move the process forward. Our effort is the latest in a series of initiatives by the FSMB License Portability Project, which is funded by a grant from the U.S. Health Resources and Services Administration. Interstate compacts are contracts between two or more states that allow them to maintain their sovereignty while acting collectively outside the confines of federal legislation or regulation. States have used interstate compacts historically to address a variety of issues — an example is the compact created to allow drivers with licenses issued by individual states to use all of the nation’s freeways. Fundamental to our approach is creating a system that enables multi-state practice by physicians while preserving the current state-based regulatory system. This includes ensuring that state boards would retain their individual authority for discipline and oversight within a new interstate compact system. Many details remain ahead as we tackle this historic effort, but we are making good progress in defining key foundational principles and guidelines. The interstate compact has obvious ramifications for the growth of eHealth. Ultimately it will help streamline the process of multi-state licensure and thus aid those involved in eHealth. To ensure our Fundamental to our approach is creating a system that enables multistate practice by physicians w hile preserving the current state- based regulatory system. efforts at portability are aligned with the need for new policies related to the growth of eHealth, I have formed a workgroup specifically tasked with reviewing the FSMB’s telemedicine policy. The work of these two FSMB groups — one developing the interstate compact model and the other reviewing the FSMB’s telemedicine policies — will help us achieve a well integrated and carefully thought-out approach to the twin challenges of portability and the rise of eHealth. By focusing on these three priorities — the physician workforce, MOL and eHealth — I believe the regulatory community can make significant contributions to the nation’s efforts as we confront our health care challenges. I look forward to a very busy and productive year in service to you as we pursue these tasks. n J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 7 PA S T A N D P R E S E N T “Past and Present” couples an excerpt from an article that appeared previously in the pages of the Journal or its predecessor, the Federation Bulletin, with a companion essay authored by an invited commentator. Here, Mari Robinson and Leigh Hopper, executive director and former public information officer respectively for the Texas Medical Board, respond to the legal and practical issues raised by an editorial on the topic of national medical licensing that was published by the FSMB nearly a century ago. The editorial, written by Manford M. Clapper on a “Federal Licensing Board,” originally appeared in the April 1914 issue of the Quarterly of the Federation of State Medical Boards. Federal Licensure: 100 Years Later, the Central Questions Haven’t Changed Much By Mari Robinson, JD, and Leigh Hopper Medical regulators are familiar with the concept of national licensure for physicians, which has been proposed at various times over the last century. An editorial from the Quarterly of the Federation of State Medical Boards, for example, made the legal case for national licensure in 1914: “There is a great weight of legal opinion which has been expressed in favor of the theory that there is no provision in the federal Constitution for the control of medical education, licentiation and practice – that this authority is vested in the states by virtue of their police powers. I take issue with the opinion that the Congress has no right to encroach upon the ‘police powers’ of the individual states. I base my opinion that the Congress has power to provide for the general welfare on a clause in the Constitution, and that it has power by virtue of this to control the practice of medicine, on a leading decision of the Supreme Court (Dent vs. West Virginia) wherein it was declared that a state had authority to regulate the practice of medicine as part of its power to provide for the general welfare; it is on this secure foundation that I find proof that the Congress has power to authorize a federal licensing board or to enact a national medical registration law. The Supreme Court and the federal Consti tution…respectively grant to the states and to the federal Congress the concurrent power to provide for the general welfare….But should the state laws and the laws of Con8 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 gress conflict, the state law must give way to the federal law, for, according to Paragraph 2 of Article VI of the federal Constitution, ‘This constitution, and the laws of the United States which shall be made in pursuance thereof, and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the constitution or laws of any state to the contrary notwithstanding.’ The recent trend of Congressional action in the passage of the pure food and drug law… is away from the strict construction which curtailed the powers of the Congress and exalted the powers of the states. This strict construction of the Constitution was assailed by Chief Justice John Marshall, who pointed out…the attempt to belittle the Union in order that the original powers of the states might be retained. He said (Gibbons vs. Ogden, 22 U.S. 219): ‘Powerful and ingenious minds, taking as postulates, that the powers expressly granted to the Union are to be contracted by construction into the narrowest possible compass…and leave it [the Constitution] totally unfit for use.’ In the future, when the Supreme Court renders its decision on the constitution ality of a Congressional act establishing a federal licensing board, its decision…will uphold the plenary powers of the federal Constitution.” Manford M. Clapper Quarterly of the Federation of State Medical Boards, April 1914 In reading the commentary by Mr. Clapper, we have to admit that it is an intriguing vision. The idea of national licensure is tempting in its simplicity. Imagine one centralized agency where all applicants would send standardized forms and checks for any money that is owed, and where uniform laws would be applied to everyone. You know, just like the Internal Revenue Service. And don’t we all love the IRS? In all seriousness, though, as governmental employees, we sincerely believe that the government exists to benefit its citizens and its goal is to ensure their “general welfare.” As noted by Manford Clapper in his editorial, this idea is the bedrock of our political system, and that cannot be disputed. However, what Mr. Clapper failed to recognize is that because this responsibility is so great, it was actually divided up by our founding fathers between the federal and state governments. The 10th Amendment to the Constitution outlines this very clearly in stating that all powers not expressly granted to federal government are reserved for the states. Mr. Clapper reasons that federal medical licensure is constitutional on the grounds that Congress has authority to oversee the welfare of its citizens. However, if this were the litmus test as to the authority of the federal government, there would be very little, if anything at all, that would not fall within its jurisdiction. Despite the author’s postulation that the Supreme Court would uphold a national licensing board in a future case, the intervening century has seen nothing from the U.S. Supreme Court that fundamentally changes states’ oversight of medical licensing and discipline. All that said, let us explore for a moment, rather than contest, the federal oversight Mr. Clapper endorses. Indeed, the notion of a national medical license is back on the table, but for reasons unimagined a century ago — namely, the rise of telemedicine. Consider the following: Prospective physicians take a nationally available licensing exam, so why not issue a national license — especially when telemedicine offers a future where doctor and patient meet in virtual exam rooms? Sounds reasonable. But a closer look at how state medical boards protect the public reveals that the regulation of medicine — and the due process afforded to licensees—is a complex, personnelintensive process. For starters, physician applicants undergo a thorough review as part of the licensure process. The first hurdle to national licensure would be stakeholders coming together and agreeing upon a single set of qualifying standards for licensure. As the saying goes, if you’ve seen one medical board’s standards, you’ve seen one medical board’s standards. Each board is unique, for reasons that developed to meet the needs of its home state. This is not to suggest that a single set of qualifying standards would be impossible; but rather to point out the complexity of such an undertaking. Secondly, national licensure would not eliminate the need for …national licensure would not eliminate the need for a trained workforce to analy ze application materials from thousands of prospective licensees annually. a trained workforce to analyze application materials from thousands of prospective licensees annually. These needs and costs would still exist, but would likely be funneled to one office rather than be distributed widely as they are now, and thus the benefits to sharing the workload would be lost. While there would be many challenges in setting up the licensing component, these would pale in comparison to the disciplinary aspects of the system, such as the need for investigation of complaints. Most state medical boards currently expend the vast majority of their resources on this function. Some investigations, such as those involving pill mills, require physical inspections. Here, too, national guidelines would have to be set in order to govern the process for complaint handling, investigation and resolution. Some might argue that one way to solve this issue would be the creation of a federal license, leaving enforcement activities related to licensing to the J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 9 states. But this solution creates as many problems as it solves. For example, consider this scenario: A Texas doctor, already licensed in the state, obtains the new “federal” license. One aspect of his practice includes telemedicine: Though he lives in Dallas, he treats patients located in Santa Fe, New Mexico, which is about 650 miles away. This should work perfectly…until something goes wrong. The patient is left without any immediate assistance from his or her original provider. New Mexico, which has no authority over the provider, can do nothing to protect its own citizens. Texas can try to investigate, While there would be many challenges in setting up the licensing component, these would pale in comparison to the disciplinary aspects of the s ystem, such as the need for investigation of complaints . but it is limited by its own subpoena power to evidence located within its own state, and if any of the evidence is located in New Mexico it will not be available in Texas. But what if a law passes stipulating that with a federal license, the state in which the physician received his originating license is granted subpoena power in another state? Even if the Texas board can extract information and/or testimony located in New Mexico and takes action against the Texas physician, this doesn’t impact his federal license. To resolve this issue, the federal agency would need authority so that measures taken by a state board could be applied to the federal license. But even more issues now appear: What happens should the hypothetical physician presented here contest the action against the federal license? In this mix of state and federal jurisdiction, who prosecutes the case? Who hears the case? One of the already heavily burdened federal courts? 10 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 Funding is another matter that would have to be addressed in a federal system. Every state has a licensure fee that allows for a throrough evaluation of licensing applications, competent investigation of complaints and educational efforts to inform licensees of medical regulations. These costs would still continue to exist, though the overall amount of funding would decrease since physicians would only have one license rather than multiple licenses. The charge for a federal license could be increased in an attempt to cover these costs. It is likely, though, that the cost would have to be several times the current licensure fees in order to approach the current levels of funding. Moreover, political pressure would certainly be exerted to keep fees low. With all of this in mind, when does the creation of a federal license begin to undercut the funding of individual state medical boards? Interestingly, the debate about whether a national licensing system could be imposed by the federal government is likely moot. It has been established that the federal government can gain compliance from the states by making their participation in national programs or guidelines optional, but at the same time tying their participation to national funding for other programs. A national medical licensing system of some kind may be in the future of medical regulation, but it would require a sea change in philosophy, process and funding that would take time to implement. It is unlikely that a sweeping mandate, quickly issued, would be successful. Much more innovative thinking on the complex issue of federal licensure will be required before it is likely to move forward in the United States. The topic is just as relevant in 2013 as it was in Manford Clapper’s day, and the conclusions that can be drawn haven’t changed much: Achieving the efficiency benefits of federal licensure may bring additional costs that are simply too high to pay. n About the Authors Mari Robinson, JD, is executive director of the Texas Medical Board. Leigh Hopper is a former public information officer of the Texas Medical Board. State Medical Board Exposure to Threats of Violence Analysis of data from a national survey to determine the extent of threats of violence aimed at U.S. state medical boards and steps they take in response to the issue ........................................... By Kelly C. Alfred, MS; Timothy Turner, BBA; and Aaron Young, PhD ABSTRACT: Between 2010 and 2012, the Federation of State Medical Boards Research and Education Foundation (FSMB Foundation) conducted a survey of state medical boards in an effort to ascertain the extent to which state medical board members and staff have experienced threats of violence and the actions taken by state boards in response to such threats. The survey also assessed current and anticipated levels of security being provided by state boards. Of the 70 boards queried, 37 responded, with 73% (n=27) of these boards reporting that their board members and/or staff had experienced either explicit or implied threats of violence. These threats targeted board members (85%), board staff (78%) and others (15%). Many of the threats directed at board members occurred after board meetings and/or hearings and were made by either a physician or a family member of a physician. Most of the threats directed at board members, staff and others were verbal, including threats of death. Most boards provide a security presence at board meetings, ranging from local law enforcement agencies to private security firms, but less than half of the respondents in the survey expressed satisfaction with their present security level. The results of the survey suggest that the state medical board community should be aware of the potential for violence against board members and staff, and should formulate prevention and threat-assessment policies as a precaution. Educational and training resources may be needed at the state board level. This could include the development of educational modules to train state public officials in conflict management, the prevention and handling of acts of violence, and how to identify and assess the seriousness of a potentially violent or stressful situation. Introduction Violence and threats of violence in the workplace, topics that have been increasingly featured in the news, are serious public health problems. According to the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health, an estimated 1.7 million injuries per year are due to workplace assaults, with simple assault the most common type of violence.1 In addition, the Bureau of Labor Statistics has reported homicide as the fourth-leading cause of fatal occupational injury in the United States. Of 4,349 fatal work injuries reported, 521 were related to workplace homicides in the preliminary count for 2009.2 Certain occupations experience higher rates of violence directed at those who work in those professions (e.g., police officers, security guards, taxi drivers, and gas station workers). While the health care community has not experienced high rates of violence compared to these other settings, verbal and physical violence against physicians, other health care workers and staff is not uncommon. From 1997–2009, 8,127 occupational homicides occurred.3 Of the 73 homicides reported to have occurred in the health services industry, 20 occurred in hospitals and 17 in offices and clinics of medical doctors.3 The stressful environment in some health care settings, the prevalence of weapons among patients, their families and friends, and the increasing number of acute and chronic mentally ill patients seeking health care related services all contribute as risk factors in violent attacks against physicians and health care workers.4 Numerous cases of violence against physicians have been reported in the last few years, putting a national spotlight on violence and security issues in health care settings. As an integral part of the U.S. health care system, the state medical board community has cause to view these trends with concern. Moreover, the stressful conditions that often accompany state medical board investigations and disciplinary actions can create highly contentious and emotionally charged environments — which could be considered potential precursors to violence or violent threats. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 11 Perhaps the most visible illustration of this possibility can be found in the case of Trent Pierce, MD, a practicing family physician and board chair of the Arkansas State Medical Board. On the morning of February 4, 2009, Dr. Pierce was critically injured when a bomb exploded in his car as he prepared to travel to a board meeting, a calculated attack leaving him severely burned and without his left eye.5 Soon after the bombing, federal agents arrested an Arkansas physician on charges of illegally owning high-explosive grenades. The physician had become a “person of interest” in the attack against Dr. Pierce. According to prosecutors, the attack against Dr. Pierce was planned in retaliation after he and the Arkansas State Medical Board revoked the physician’s prescription writing privileges.6 After hearing a month’s worth of evidence, including testimony from Dr. Pierce, a federal jury convicted the physician on August 9, 2010, on charges of using a weapon of mass destruction against a person and destroying a vehicle with an explosive device. On February 28, 2011, he was sentenced to life in prison for orchestrating the attack against Dr. Pierce. On June 13, 2013, the physician petitioned the U.S. Supreme Court to review his case.7 While the violent attack against Dr. Pierce represents an extreme case — one that resulted in extensive national media coverage — the general topic of violence or threats of violence Methodology Purposes To better understand the extent of violent threats experienced by the board members and staff of the nation’s 70 state and territorial medical boards, and to generate useful knowledge for the boards, the FSMB Foundation developed an online survey. While the primary objective of the survey was to estimate the extent of violent threats against state board members and staff, the survey was also established as a way to determine the actions taken by state boards in response to the threats of violence, and the security measures boards currently have in place. Design The survey was designed to be simple to complete to ensure that a substantial portion of the target population would respond. The survey did not attempt to gauge the frequency of threats or to analyze the root cause(s) of violence against state board members and staff, but to explore the risk of exposure to violence. The survey consisted of four distinct sections: 1. T he occurrence of explicit or perceived threats against board leadership and staff. 2. T he actions boards took in response to the threats of violence. 3. T he boards’ current and future security measures for board leadership and staff. 4. Q uestions about state legislation regarding the consequences of threatening a public official. Most of the threats directed at board members, staff and others were verbal, includING threats of death. aimed at state medical board members or staff has not received attention in academic literature or been closely studied. Despite the recent high profile of incidents of violence in health care settings, the nature and extent of how the problem might impact state medical boards remain largely unknown. The dearth of data prompted the FSMB Foundation to develop and distribute an online survey designed to determine the extent of violent threats against state medical board members and staff, and how state boards respond to the issue. 12 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 Data Collection The online surveys were generated by the FSMB Foundation and were administered using the webbased survey tool, Survey Monkey. The online surveys were initially distributed via email to all 70 state medical boards in October 2010. The invitation to participate in the study was emailed to all state board executive directors and included a link to the online survey. State boards were asked to complete the online survey six weeks after receiving the invitation. Initial data was shared with representatives of state boards at the FSMB’s 2011 Annual Meeting, who suggested that the survey be distributed a second time to generate additional responses. The FSMB Foundation redistributed the violence survey via Survey Monkey in January 2012 to the executive directors of those boards who had not responded to the initial survey. The questions asked on the redistributed survey were identical to those of the original survey. Boards were asked to complete the online survey within 30 days after receiving the subsequent invitation. In both rounds of data collection, respondents were asked to identify their board affiliation but were not required to respond. Fifteen fundamental questions were developed for this study: 1.In the history of your board, have there ever been any threats of violence (either overt threats or covert perceived threats) against board members or board staff? 2.If there were threats, were they against board members, board staff or others? 3.If there were threats of violence, what type of action(s) did the board take? 4.If your board is appointed by the governor and there was a threat, did you notify the governor’s office? Results Of the 70 state medical and osteopathic board executives receiving the initial survey, 22 were returned (31.4%). Of the 22 responding boards, 16 (73%) noted their board affiliation: Colorado, Washington, D.C., Georgia, Montana, North the state medical board communit y should be aware of the potential for violence against board members and staff, and should formulate prevention and threat- assessment policies... Carolina, Nevada-Medical, Nevada-Osteopathic, Ohio, Oklahoma-Medical, Oklahoma-Osteopathic, Tennessee-Medical, Texas, Washington-Medical, Washington-Osteopathic, Virginia and the U.S. Virgin Islands. 7.What type of security does your board provide? Subsequently, when the survey was redistributed in January 2012 to the 48 remaining boards, 15 additional surveys were returned (response rate, 31.3%). Boards participating in this second round of data collection included Connecticut, Florida-Medical, Hawaii, Idaho, Indiana, Kentucky, Maryland, Maine-Medical, Maine-Osteopathic, Mississippi, Nebraska, New Hampshire, West Virginia-Medical and West Virginia-Osteopathic. 8.If your board routinely provides security for specific individuals, which individuals do you cover? Combining the results from the first and second rounds of data collection produced an overall survey response rate of 52.9% with 37 returned surveys. 5.If you notified the governor’s office, what was their response? 6.For whom does your board routinely provide security? 9.If your board routinely provides security, where do you provide it? 10.Please comment on your future plans for security. 11.If you are planning to change your level of security, what are you planning to do? 12.What barriers do you face in providing the level of security you would like? 13.Does your state have legislation regarding consequences of threatening a public official? 14.Would you be interested in pursuing legislation in your state if a draft were provided to you? 15.What other comments do you have? Board Experiences with Threats of Violence Based on the pooled data, of the 37 state boards that responded to the question of whether their board members or staff have ever experienced threats of violence at the board level, 73% (n=27) reported that in the history of their board, there had been threats of violence (either overt or covert [explicit or perceived]) against board members or board staff (see Figure 1). Of the responding states, 85% indicated that board members had been the target of violent threats, followed by board staff (78%) and others (15%). Threats directed at “others” included individuals who are associated with a state board, but not employed by a board, such as an assistant attorney general, a hearing officer, a district judge, and, in one case, the state’s governor. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 13 Many of the threats directed at board members occurred after board meetings. Most of the threats were made by either a physician or a family member of a physician, and were verbal, including threats of death. Actions Taken by State Boards in Response to Threats of Violence When asked what actions were taken as a result of threats of violence, the responding boards indicated the vast majority of actions taken revolved around ensuring a security presence at board meetings, whether that was through local law enforcement agencies or the hiring of private security. Most state boards that experienced threats of certain occupations experience higher rates of violence directed at those who work in those professions... violence tended to notify law enforcement (62%) or seek private security (38%). For 48% of boards, the threat(s) resulted in law enforcement investigations (see Figure 2). Boards seldom notified the governor’s office of a threat (25%). When they did, the governor’s office would take note of the information and then instruct them to contact and coordinate with capitol police or proper law enforcement to ensure the issue(s) was addressed properly. Current Security Approximately 76% of the respondents indicated that their board provides some type of routine security. For these boards, security is typically provided at board offices (69%) and board meeting locations (62%). The type of security varies, but locking office doors (47%) or having offices in buildings that require identification for access (42%) are the most widely used security types. Private security (33%), local law enforcement (28%), and panic alarm systems (19%) are also utilized. Seventeen percent of the respondents reported their board did not provide any kind of security (see Figure 3). Satisfaction and Future Plans for Security As indicated in Figure 4, less than half of the respondents (49%) are satisfied with their security but only 26% are planning to increase it. However, if finances were no object, 72% would choose to increase their security. 14 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 For the eight boards planning to change their level of security, four are considering a security presence at board meetings, one is taking steps to better secure its office building by installing video cameras, one is having security use handheld metal detectors at meetings, one is adding a panic button at the receptionist desk and another is moving to a new building with security officers, bag checks and scanners — although the move was not related to security. For the boards that are not planning to make any security changes, funding to pay for added security (both initial and ongoing) is the primary barrier. Building factors are a distant second (i.e., a building houses other entities or must allow for public access when open). Legislation Approximately 64% of the responding boards indicated that their state has legislation regarding consequences for threatening a public official. However, only 39% indicated they would be interested in pursuing legislation in their state if a draft were provided (see Figure 5). Among those responding to this question, a handful provided additional comments: “Members of the board and board staff do not have the ability to lobby the legislature.” Figure 1 Any threats (ever) of violence against board members or staff? Uncertain 5% No 22% Yes 73% Figure 2 Type of action(s) taken by boards due to threats of violence Law enforcement at board meetings or offices 62% Law enforcement investigation 48% Private security at board meetings or offices 38% Law enforcement protection of individual members or staff 17% Legal action (e.g. restraining order) 14% Private security protection of individual members or staff 10% Other 24% 0% 10% 20% “Yes, if it (the legislation) is reasonable in the expectation and fiscal impact.” “Board members are employees of the state and have the same protective rights as state workers.” “Don’t know if there is current law on this subject. At this time, don’t feel the security threats we have experienced to date warrant such legislation.” Discussion The results from this study indicate that threats of violence against state medical board members and staff are not uncommon. The finding that nearly three-fourths of the state boards that responded to the survey had experienced some form of violent threat is remarkable and suggests that the issue occurs in a wide range of jurisdictions. Executive directors reported a variety of threats anecdotally, including both explicit and perceived forms, and including threats of death. In one reported incident, the threat was so credible that a board staff member wore a Kevlar vest during a hearing for his own protection. In another, a physician under investigation by a board threatened to bring a bomb to a board meeting. 30% 40% 50% 60% 70% Survey results show that state boards have taken steps to respond to such threats of violence. However, while less than half of the respondents are satisfied with their present security level, only 26% are planning to increase security. The initial and ongoing costs for additional or new security are the primary barrier, as 72% indicated they would increase security if finances were no object. It is important to note that this survey was limited in scope and should be considered only the beginning of an effort to better understand the issue of ...the stressful conditions that often accompany state medical board investigations and disciplinary actions can create highly contentious and emotionally charged environments. violence aimed at state medical boards. For example, respondents were asked if there have “ever” been threats of violence against their J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 15 Figure 3 Types of security provided by boards Law enforcement presence 47% Locked building requiring ID for access 42% Private security presence 33% Law enforcement presence 28% Panic alarms 19% Monitored alarm system 17% None 17% Video or audio/ video monitoring 14% Metal detectors 8% Bag searches 8% Other 14% 0% 10% 20% boards, without a specific timeframe, raising the possibility of recall bias. More research examining specific time periods could yield a better Many of the threats directed at board members occurred after board meetings. Most of the threats were made by either a physician or a family member of a physician... understanding of the scope of the problem and the direction of any trend lines in the incidence of violent threats. 16 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 30% 40% 50% Additionally, more analysis should be conducted on the demographics of state boards and whether there are any correlations between board composition, geographic location and the incidence and nature of violent threats. Further study could also examine the role of other agencies, such as the Occupational Safety and Health Administration (OSHA), in helping state boards address the potential for violence against state board members and staff as a unique workplace issue. A comprehensive study of the incidence of actual acts of violence throughout the medical regulatory community could also yield important data. In responding to this survey, board executive directors provided a description of physical violence in Figure 4 Percentage of boards answering "yes" to the following 80% 60% 40% 72% 49% 20% 26% 0% Satisfied with your present level of security? Planning to increase your security? If finances were no object, would you increase your security? Figure 5 Interested in pursuing legislation in your state if a draft were provided to you? addition to violent threats, ranging from an incident in which a physician whose license had been suspended fire-bombed the house of a witness to an altercation in a parking lot in which board members were accosted following a hearing. These survey findings suggest that the state medical board community should be aware of the possibility of violent threats. Since it is impossible to know if and when a violent threat might be carried out, understanding the risk factors and formulating prevention and threat assessment policies may be the most effective approach to addressing the issue. Additionally, educational and training resources may be needed at the state board level. This could include the development of educational modules to train state public officials in conflict management, the prevention and handling of acts of violence, and how to identify and assess the seriousness of a potentially violent or stressful situation. n About the Authors Kelly C. Alfred, MS, is Director of Education for the FSMB Timothy Turner, BBA, is a member of the Texas Medical Board and the FSMB Foundation Aaron Young, PhD, is Senior Director of Research and Data Integration for the FSMB References: 1.Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health. US government occupational violence links. http://www.cdc.gov/niosh/topics/ violence/. Retrieved September 12, 2013. 2.Bureau of Labor Statistics. 2010. National Census of Fatal Occupational Injuries Summary, 2009. Washington, DC: U.S. Department of Labor. Not applicable 32% Yes 39% 3.Bureau of Labor Statistics. Occupational homicides by selected characteristics, 1997-2009. http://www.bls.gov/iif/ oshwc/cfoi/work_hom.pdf. Retrieved September 12, 2013. 4.Bureau of Labor Statistics. 2004. Guidelines for Preventing Workplace Violence for Health Care and Social Service Workers. http://www.osha.gov/Publications/OSHA3148/ osha3148.html. Retrieved September 12, 2013. 5.Robbins, Liz. “Bomb Injures Arkansas Doctor.” The New York Times. 4 February 2009. http://www.nytimes.com/2009/02/ 05/us/05explode.html?_r=0. Retrieved September 12, 2013. No 29% 6.Federation of State Medical Boards’ Board Action Database. Summary of Reported Actions. Accessed September 12, 2013. 7.“Randeep Mann Petitions High Court to Hear Bombing Case.” 30 June 2013. http://arkansasnews.com/sections/news/ arkansas/randeep-mann-petitions-high-court-hear-bombingcase.html. Retrieved August 8, 2013. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 17 Obtaining Meaningful Informed Consent: Guidelines from the Maine Board of Licensure in Medicine ............................................................... David Nyberg, PhD A B S T R A C T : Each year the Maine Board of Licensure in Medicine deals with a large number of complaints from patients and their families about various degrees of physicians’ failure to obtain informed consent in a meaningful and useful way. Physicians typically respond that they (or someone on staff) went through their usual procedure and they often — but not always — produce a signed consent form to prove that consent was in fact obtained. They often express surprise that a complaint had been filed after the fact. There is a communications gap between what the physician offers and what the patient formally affirms with a signature in terms of information, comprehension and meaningful consent. The Maine Board of Licensure took on the task of exploring this gap with the purpose of developing a set of guidelines to help physicians prevent these complaints by achieving a higher quality of shared decision making. Keywords: Maine Board of Licensure in Medicine, informed consent, shared decision making Approximately one-third of cases the Maine Board investigates each year include allegations of failure to obtain adequate and meaningful informed consent, sometimes as a major issue but more often as a contributing factor to some other issue(s). Recognition of this fact motivated the board to conceive and disseminate guidelines for Maine physicians with the purpose of reducing the number of complaints of this kind, at least those that are reasonably within the physician’s control to prevent. Anticipating the question of how a board might proceed in light of this conflicting legal environment, Miller recommended the following: These guidelines are included with the board’s response to each new application and renewal submitted to the board. Various board members have presented these guidelines to the primary residency training programs in Maine and we expect to do this annually. The board also includes a copy of the guidelines with letters of guidance when appropriate. The guidelines do not carry statutory weight but they do serve to inform the profession of what the board considers best practice with regard to obtaining meaningful informed consent. A pproximately one - third of cases Readers of JMR will be familiar with the subtle and useful summary of legal findings on informed consent in several states by Tim Miller, JD, published in a previous issue under the title “Informed Consent: A Medical Board Analysis.”1 In his article, Miller showed convincingly that “courts are divided on how to proceed with informed consent cases…and have used three different standards — prudent physician, prudent patient and subjective patient — to determine if the physician adequately informed the patient.”2 18 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 “The board can first ask, ‘What would a prudent patient want to know?’ This question can be followed with, ‘What is the community standard for disclosing sufficient information to meet the disclosure requirements for the reasonably prudent the Maine Board investigates each y ear include allegations of failure to obtain adeq uate and meaningful informed consent … patient?’ Finally, the board can ask, ‘Did the disclosed information take into account the specific subjective needs and concerns of the patient and did the patient place any restriction or conditions on the care provided by the physician?’”3 State boards of medicine can be grateful for Miller’s provision of the legal motivation for obtaining informed consent in a thorough manner, which is in itself compelling, but there is another slant on why doing so makes sense for physicians. In addition to providing legal protection, obtaining meaningful informed consent is the right thing to do from an ethical perspective that includes, but also exceeds, legal considerations. Even if no laws against battery or medical negligence or violations of selfdetermination were on the books, it would still be the physician’s obligation to respect in practice a patient’s right to self-determination or, as some call it, autonomy. There are legitimate exceptions, of course. Providing emergency medical care to incapacitated patients is a familiar example, as would be providing routine care for minor medical problems. But when major diagnostic, invasive or therapeutic procedures are involved in a medical decision, the patient has a right to full participation. It is in this spirit that the Maine Board of Licensure in Medicine offers its best effort in guiding physicians along this difficult and sometimes tricky path toward genuine shared decision making.4 The Board hopes that its guidelines, published here, will provide useful information for other states grappling with issues related to informed consent. Informed consent Guidelines from the Maine Board of Licensure in Medicine* Obtaining and recording informed consent before major diagnostic, therapeutic, and invasive procedures is a physician’s professional and legal obligation. Patients have the legal right to grant or withhold informed consent, either personally or through lawful representatives. The term “informed consent” first appeared in an amicus curiae brief filed by the American College of Surgeons in the case of Salgo v. Leland Stanford University in 1957.** While not all physicians and not all patients desire to be involved in a shared decision-making process, prevailing negligence law and the legal right to self-determination now require some documentation of informed consent for most major treatments and procedures. Physicians therefore have a legal motivation for obtaining and recording informed consent for major treatments and procedures, subject to recognized legal exceptions, such as in providing emergency medical care to incapacitated patients. In addition to this legal *Title 32 M.R.S.A. § 3269(3) authorizes the board to “license and set standards of practice for physicians and surgeons practicing medicine in Maine.” However, nothing in this document is intended to affect the definition of “informed consent” for civil medical malpractice actions as defined by Title 24 M.R.S.A. § 2905. **154 Cal.App.2d 564. motivation, the board believes physicians ought to be motivated by a commitment to the ethical value of patient self-determination, or personal autonomy. Therefore, the board offers these guidelines for physicians practicing in Maine. The Goal The goal of offering these guidelines is to help physicians move beyond a limited consent model that emphasizes primarily the physician’s legal obligation to disclose information and the patient’s legal right to make independent decisions. The board advocates a different model that emphasizes communication and encourages a certain kind of transaction between patient and physician. The norms that govern such transactions are clarity, relevance, accuracy, and sincerity. There is no standard form, nor any uniform procedure that will fit all cases calling for informed consent in this model, but there is an underlying ethical obligation to make it possible for the patient and the physician to participate together in a transaction that takes into account the norms of clarity, relevance, accuracy, and sincerity. The board is concerned here with major diagnostic, therapeutic, and invasive procedures, and not so much with routine decisions about minor medical problems. In certain cases, physicians may simply explain that they see many people with a particular problem and regularly with success treat the In addition to providing legal protection , obtaining meaningful informed consent is the right thing to do from an ethical perspective… problem in a particular way, then ask if the patient has any questions about the problem or the treatment. In these cases, if the patient makes statements or asks questions indicating discomfort, lack of understanding, or continuing uncertainty, then the following guidelines apply. Shared Decision Making The primary value of documented informed consent is that it represents the existence of a relationship between physician and patient that is based upon, or at least includes, an element of shared decision making. Shared decision making for the patient is not the same as mere acquiescence, or compliance based on partial or slanted information, or indifference J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 19 due to habit or apathy, nor is it the same as conformity to custom — such as the custom of “following doctor’s orders.” Shared decision making is a process for reaching a shared conclusion through informed judgment. be free of personal self-interest, and religious, political, racial, and gender bias. The board encourages physicians to remind patients of their right to have someone with them (an advocate of some kind) during these discussions, as patients can be overwhelmed, frightened, and confused when confronting an important medical decision. …when maj or diagnostic , invasive , or therapeutic procedures are involved in a medical decision , the patient has a right to full participation. Such a process is an educational ideal in the field of medical care, as it is throughout most institutions in a democratic society. The heart of the matter is the control of information: to the extent information about a problem can be shared, decisions about potential solutions can be shared. Physicians have privileged access to medical information through their education, experience, and expertise. This privilege carries with it the duty to disclose clearly such information as is relevant and is supported by accurate scientific information in a sincere manner for consideration by the patient. Furthermore, this duty is itself governed by the physician’s fiduciary obligation to protect the patient’s best interests. Generally, physicians control the medically relevant information patients need in order to ask the questions they may want to ask but might not be able to formulate on their own. Successfully sharing that information is a matter of 1) the physician’s willingness to do so, and 2) the physician’s ability to apply the skills of communication required to do so. It is also a matter of 3) the patient’s willingness to participate in the process, and 4) the patient’s ability to understand the information, apply it to his or her situation, and then express a reasoned judgment based on the relevant medical information as well as on personal values, wishes, and goals. If there is any doubt about the patient’s ability in this regard, the physician should arrange an evaluation of the patient’s capacity by a qualified colleague. The physician personally initiates the process of informing the patient by presenting the medically reasonable options relevant to the patient’s condition. The medical reasonableness of these options is tied to the available and reliable evidence base of expected benefit and risk for each alternative. The physician’s judgment about these options should 20 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 Skills for Eliciting Informed Consent By far the most important skill is empathetic listening, which is the capacity for acquiring objective knowledge about the perspective taken by another person. It is a way of listening that requires temporary suspension of one’s personal point of view while trying to assume another’s point of view. It is a means for gathering data. It is not synonymous with being compassionate or sympathetic, even though its mere presence can have a beneficial effect. The primary purpose of empathy in this sense is to become well informed about the patient’s point of view. It is important for the physician to find out what and how much the patient already knows and what more the patient wishes or needs to know, and to what extent the patient desires to participate in the decision making process. In disclosing medical information the physician can err in two ways — excess and deficiency. Empathetic understanding can help guard against going wrong in either of these ways. Next is skill in disclosing and explaining. In trying to establish the basis for shared decision making, the physician discloses medical information relevant to the case at hand, and provides explanations of what that information means, in language that is intelligible to the patient. It is important to distinguish between two useful but distinct kinds of explanation. The first is scientific explanation, which is making a case for T he board advocates a different model that emphasizes communication and encourages a certain kind of transaction betw een patient and physician. why certain events are the way they are and for predicting future events. The second is semantic explanation, which by contrast is making the meaning of something clear to the listener. Semantic explanation is like translation or paraphrase, using different words and terms until the intended meaning is revealed and understood. An explanation can be satisfactory from a formal (scientific) point of view, while at the same time failing to be satisfying from the patient’s point of view. Another way to put this point is that while a medical explanation of risks and benefits associated with treatment options can be scientifically sound, the listener may find it to be unintelligible, and therefore not useful as information upon which to grant or withhold consent. Informed consent depends on the physician’s success in providing both kinds of explanation. Third is framing. Anything that can be said, can be said another way. Decisions are often influenced by the way alternatives are presented. For example, the outcome statistics for 100 middle-aged men undergoing surgery for lung cancer can be described as “90 survive the surgery…and of those 90, 34 are alive at the end of 5 years.” An alternative way of expressing (framing) the same results might be: “10 die from surgery…and 66 more die within 5 years.” Typically, for a patient choosing between surgery and radiation, surgery appears much less attractive when described using mortality rather than survival statistics. The difference between 10% mortality (for surgery) and 0% mortality (for radiation) is more impressive than the difference between 90% survival (for surgery) and 100% survival (for radiation). A physician may knowingly or unwittingly nudge a patient toward one option simply by the way the range of options is described, or framed. (Note that 5-year mortality statistics for radiation only have not been mentioned.) vention(s), to the extent the patient wishes, all questions then having been answered to the patient’s satisfaction. 3) The patient gives consent in writing to major intervention(s) agreed to jointly with the physician. Nota Bene: Obtaining informed consent is the physician’s personal responsibility. This responsibility cannot be wholly delegated. Other medical staff (PAs, NPs, physicians-in-training and others) may usefully participate in the process, but no amount of shared videos, questionnaires, and pamphlets can substitute entirely for personal communicative transaction with the responsible physician. Finally, proof of informed By far the most important skill is empathetic listening, w hich is the capacity for ac q uiring objective knowledge about the perspective taken by another person. consent cannot be reduced merely to a signature on a form. A note from the physician about the process of gaining that signature should be attached to the form. When a physician assistant, with proper delegation, performs a diagnostic, therapeutic, or invasive procedure for which the standard of care indicates informed consent is required, the board expects the physician assistant to take the same actions as are described in this document for the physician. n About the Author Definition of Informed Consent In conclusion, the board recommends the following definition of informed consent be adopted and applied by Maine physicians. David Nyberg, PhD, is a Clinical Professor of Psychiatry at Tufts University School of Medicine and Maine Medical Center. He is also a member of the Maine Board of Licensure in Medicine. Informed consent for treatment has been obtained when: 1. Miller T. Informed consent: a medical board analysis. J Med Reg. 2010/2011;96(3): 16-22. 1) The physician has disclosed and explained to the patient’s satisfaction the process used to arrive at the medically reasonable and recommended intervention(s), which is based on reliable evidence of expected benefit and risk of each alternative, and which is free of any impermissible bias. 2) The patient, who has demonstrated capacity, has been given ample opportunity to ask questions about the process and the recommended inter Endnotes 2. Ibid., p. 20. 3. Loc. cit. 4.Readers are encouraged to consult these excellent papers on shared medical decision making: Jaime Staples King and Benjamin Moulton, “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law & Medicine, 32 (2006): 429-501; Benjamin Moulton and Jaime S. King, “Aligning Ethics with Medical Decision-Making: The Quest for Informed Patient Choice,” Journal of Law, Medicine & Ethics (Spring 2010): 85-97; Jaime S. King, Mark H. Eckman, and Benjamin W. Moulton, “The Potential of Shared Decision Making to Reduce Health Disparities,” Journal of Law, Medicine & Ethics (Spring 2011): 30-33. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 21 LEGAL BRIEFS By Eric M. Fish, JD Senior Director, Legal Services Federation of State Medical Boards ............................... Antitrust Court Battles in North Carolina Have Significant Implications for State Medical Boards On May 31, 2013, the United States Court of Appeals for the Fourth Circuit rejected the North Carolina State Board of Dental Examiners claim that actions taken against non-dentist providers of teeth whitening services were exempt from antitrust laws. The board relied on the state action doctrine, which provides state and municipal actors immunity from federal antitrust lawsuits for actions taken pursuant to expressed policies with foreseeable anticompetitive effects as the basis for the exemption. The Court further held that the board’s conduct violated Section 1 of the Sherman Act, dismissing the board’s argument that it was both incapable of conspiring with itself to enact an anticompetitive scheme that restricted trade and that the conspiracy imposed an unreasonable restraint of trade. The Court’s decision to revisit the scope of the state action doctrine is a significant development that has the potential to impact state medical boards in the future. At issue in this case was a board action directed at providers of teeth whitening services that were not licensed dentists. Starting in 2003, the board issued 47 cease-and-desist letters to 29 non-dentists that provided teeth whitening services. The board issued the letters after an investigation by a panel chaired by a board member and board The C ourt ’s decision to revisit the scope of the state action doctrine is a significant development that has the potential to impact state medical boards … staff. The board relied on the state’s Dental Practice Act in order to empower it to restrict all but state-licensed dentists from offering teeth whitening services in North Carolina. The board 22 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 also contacted malls where teeth whitening kiosks were operating and requested that the malls refrain from leasing space to providers of such services. In June 2010, the Federal Trade Commission filed an administrative complaint against the board for its actions. The board sought to dismiss the complaint on the grounds that the board and its actions were immune from antitrust scrutiny Particularly relevant to the Court in making this decision was the role that dentists play ed in the governance of the board. under the state action doctrine. This attempt was denied, and at trial the board was found in violation of the FTC Act for unilaterally issuing extrajudicial orders to non-dentists that provided teeth whitening services. The board appealed, reasserting the applicability of the state action doctrine and further arguing that it did not violate Section 1 of the Sherman Act or unreasonably restrain trade. The Fourth Circuit dismissed the board’s contention that its actions were immune under the state action doctrine solely because it was categorized as a state agency. The recent FTC v. Phoebe Putney decision colored the opinion of the Fourth Circuit. The board’s attempt to avail itself of the state action doctrine received enhanced scrutiny and led the Court, citing the Supreme Court’s decision in Phoebe Putney, to state that reliance on the state action doctrine is disfavored and that the doctrine should only be applied “to anticompetitive conduct that is undertaken to a regulatory scheme that is the state’s own.” Finding the board to be a private actor availing itself of the protection of the state action doctrine, the board’s action must be grounded in a clearly articulated state policy and must be actively supervised by the state for the state action doctrine to apply. Crucial to this determination was the composition of the board and its procedure in issuing the cease-and-desist orders. Particularly relevant to the Court in making this decision was the role that dentists played in the governance of the board. The overwhelming majority of board members were chosen by a vote of licensed dentists and not by a state actor. The lone public member on the board appointed by the governor was not involved in any substantive decisions of the board. Upon review of the circumstances surrounding the issuance of the cease-and-desist letters, the Court found the necessary state supervision The board’s reliance on theoretical harms that could befall consumers did not s way the C ourt. provision wanting. The Court stated “here the cease and desist letters were sent without state oversight and without the required judicial authori zation.” Further, the Court refused to accept the board’s assertion that compliance with North Carolina’s basic reporting requirements amounted to state supervision. Addressing the anticompetitive effect of the board’s actions under the Sherman Act, the Court agreed with the FTC that the board’s issuance of cease-and-desist letters resulted from a “combination or conspiracy” intended to decrease competition. Although the board claimed its motivation was to protect the public from harm, the Court determined that the board did not present adequate facts to show that the public was being harmed by non-licensed physicians providing services. The board’s reliance on theoretical harms that could befall consumers did not sway the Court. Although the decision found the board in violation of antitrust law, the Court stressed the narrow application of its holding. The Court emphasized that the composition of the board and the lack of supervision by the state resulted in a “state board run by private actors in the marketplace taking action outside the procedures mandated by state law to expel a competitor from the market.” According to the Court, actions of similarly situated boards composed of members selected by politically accountable actors, such as a governor or legislature, and boards more actively supervised by the state may survive antitrust scrutiny. Comparison of the North Carolina State Board of Dental Examiners and the North Carolina Medical Board illustrates how the decision may paralyze activities of licensing boards. The board of Dental Examiners consists of six dentists who are licensed to practice dentistry in North Carolina, one dental hygienist who is licensed to practice dental hygiene in North Carolina and a public member. The Medical Board consists of seven members recommended by a review panel (members of medical society, osteopathic association, physician-assistants academy and nurses association) who are subsequently appointed by the governor. The other five members are appointed directly by the governor and three of them must be members of the general public, with no financial interests in a health profession. The Court’s decision does not delineate the extent to which a board, consisting of members of the regulated profession, is to be considered actively supervised for purposes of applying the state action doctrine. With this uncertainty, …the Court determined that the Board did not present adeq uate facts to show that the public was being harmed by non- licensed physicians providing services . regulatory boards may be reluctant to act in a manner that protects the public, and board members may be left to wonder if their actions are sufficiently supervised by a politically accountable actor. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 23 L E G A L B R I E F S continued With such questions left unresolved, the Board of Dental Examiners filed a petition requesting that the Fourth Circuit Court of Appeals reconsider the opinion en banc (“en banc” refers to the hearing of a legal case where all judges of a court will hear the case rather than a panel of them). The circuit will grant a hearing if the original decision sets forth an extraordinary precedent or is of exceptional importance. entity yet one that acts pursuant to government authority is an illogical interpretation of antitrust law. The board is arguing that the ruling conflicts with previous Supreme Court rulings, which articulate a standard that exempts state agencies from proving they are actively supervised for purposes of the state action doctrine. This position is also supported by the application of this exemption in other circuits, and is analogized to decisions where regulatory bodies of other professions, consisting of licensed members of that profession, were upheld. The board also relies on the principles panel’s ruling sets forth a vague and The North C arolina B ar A ssociation also has filed a new amicus brief as a result of the panel decision . of federalism, claiming that regulation of professions is a recognized police power of the state that will be diminished if the decision is upheld. The board also maintains that the panel’s ruling sets forth a vague and unpredictable standard that will undermine the ability of regulatory bodies to function. The petition explains that the decision leaves open the question of how a state board can be independent if composed in part of licensed members. Application of the decision to future conduct within the circuit, the board reasons, will open the door for any license holder (140,000 individuals residing in the circuit hold a license of some sort) to challenge any refusal to issue a license or further regulation of a license issued by a regulatory board with a member that holds the license. The board also indicates in its appeal that the decision to consider it as a nongovernmental 24 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 The North Carolina Bar Association also has filed a new amicus brief as a result of the panel decision. In its brief, the Bar Association deduces that the decision will interfere with the legislative choice T he board also maintains that the unpredictable standard that w ill undermine the ability of regulatory bodies to function . to delegate the state’s regulatory authority to boards composed of individuals with the expertise necessary to properly regulate the use of the license. The State Bar specifically lists the North Carolina Board of Medicine as one of the agencies whose purposes will be frustrated if the state action defense is lost. The FSMB and its staff will continue to monitor developments and the implications for state medical boards. n S TAT E M E M B E R B O A R D B R I E F S ............................... ............................... Alabama California New Laws in Alabama Crack Down on Prescription Drug Abuse California Board to Suspend Licenses of Physicians with Delinquent Taxes Alabama has passed three new laws intended to curb the state’s growing prescription drug abuse problem by focusing on prescription monitoring, pain management clinics and “doctor shopping.” The Medical Board of California has notified licensees that it will begin contacting those who are delinquent in tax obligations, warning them that their medical licenses may be suspended if they do not pay or begin a payment plan within 90 days. Included in the package of bills which became law on August 1, 2013, a prescription drug monitoring program The ‘doctor shopping’ bill strengthens punishments for ly ing to physicians about similar prescriptions in order to get more drugs . (PDMP) now allows physicians to give their staff members access to the state’s PDMP on their behalf. The bill also allows the state Medicaid agency to access the PDMP to check the controlled substance prescription medication history of patients enrolled in Medicaid. The pain management bill strengthens regulation of pain management clinics where drugs are prescribed for chronic, non-malignant pain. The new law stipulates that pain management clinics must be registered with the Alabama Board of Medical Examiners and must have a medical director who is a physician licensed in Alabama. Also included are provisions that allow the board to issue subpoenas while investigating clinics. The “doctor shopping” bill strengthens punishments for lying to physicians about similar prescriptions in order to get more drugs. Under the new law, lying to a physician to get drugs is a Class A misdemeanor, with convictions punishable with up to a year in jail. After four convictions, the offense becomes a Class C felony, which is punishable by a sentence of up to 10 years. In 2011, the Centers for Disease Control and Prevention identified Alabama as being among the top 20 states nationally in the number of drug overdose deaths. n State law authorizes the medical board to deny an application for licensure and to suspend the license of any licensee who has outstanding tax obligations due to the Franchise Tax Board (FTB) or the State Board of Equalization (BOE) and who appears on either the FTB or BOE’s certified lists of top 500 tax delinquencies over $100,000. Physicians who fail to either pay their obligations or begin a payment installment plan with taxing agencies will have their licenses denied or suspended until the board receives a release Physicians who fail to either pay their obligations or begin a payment installment plan with taxing agencies will have their licenses denied or suspended until the board receives a release. from the FTB or BOE. The form for requesting a release will be included with the preliminary notice of suspension. The law prohibits the Medical Board of California from refunding any money paid for the issuance or renewal of a license where the license is denied or suspended. n Source: Medical Board of California website, September 2013 Source: National Association of Boards of Pharmacy website, August 2013 J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 25 S TAT E M E M B E R B O A R D B R I E F S continued ............................... Availability of Physicians Required for Laser Procedures New regulations announced recently in California tighten safety precautions for cosmetic procedures involving lasers or pulsing light. Under rules implemented July 1, 2013, a “properly trained physician” must be immediately available whenever a licensed health care provider engages in a cosmetic procedure using a laser or an intense pulse light device. “Immediately available” is defined by the Medical Board of California as meaning that the physician may be reached by electronic or telephonic means without delay. n Source: Medical Board of California website, September 2013 ............................... District of Columbia District of Columbia Pharmacists Able to Initiate or Modify Drug Therapy, Working with Physicians Legislation recently passed in the District of Columbia will allow pharmacists, through a written agreement with a physician, to initiate or modify drug therapy for a patient. The boards of medicine and pharmacy in the District of Columbia will jointly develop and promulgate regulations to help pharmacists and physicians understand and implement the requirements of the “Collaborative Care Expansion Act of 2012.” Georgia New Guidelines Tighten Oversight of Pain Management Clinics in Georgia The Georgia Composite Medical Board has approved and released new guidelines for the licensing of the state’s pain management clinics, strengthening oversight in an effort to reduce illicit clinics there. The new guidelines were implemented in response to a dramatic rise in pain management clinics operating in the state between 2010 and 2012 — estimated by the Wall Street Journal to be an increase of 1,300% — following a crackdown on illicit pain clinics in neighboring Florida. Application for a license to open a pain management clinic now includes a $500 application fee, a criminal background check of each person with an ownership interest in the clinic, affidavits and other documentation. Under new regulations in Georgia, all pain management clinics must be licensed by the board and must renew their licenses periodically. The board can deny, suspend and revoke licenses if it finds that the licensee or a physician practicing at a licensed pain management clinic has furnished A ny person w ho operates a pain management clinic w ithout a license in the state is now guilty of a felony. The boards of medicine and pharmacy in the District of Columbia are already working on regulations to allow expanded authority for pharmacists to administer immunizations. n false information on the application, has been convicted of a crime relating to controlled substances, has had their DEA registration suspended or revoked, or has violated any provision of the state’s new pain clinic regulations. Source: District of Columbia Board of Medicine Newsletter, Summer 2013 The new regulations also stipulate that clinics not operating before July 1, 2013, must be owned wholly by physicians. Clinics or practices owned or operated by hospitals are exempt from licensing, but must file annual notifications with the board. 26 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 In addition, all pain management clinics that dispense controlled substances or dangerous drugs must be registered with the Georgia State The ne w guidelines w ere implemented in response to a dramatic rise in pain management clinics operating in the state bet w een 2010 and 2 0 1 2 . Board of Pharmacy. Any person who operates a pain management clinic without a license in the state is now guilty of a felony. When it passed its new requirements, Georgia became the ninth state in the nation to require pain clinics to be licensed or registered and to be owned by physicians. n Source: Georgia Composite Medical Board Newsletter, July 2013 ............................... Illinois Illinois Board Files Complaint Against Physician Who Named Former Patients in Defamation Suit The Illinois Department of Financial and Professional Regulation has filed a complaint against a physician The Illinois D epartment of F inancial and Professional R egulation contends that D r . Parikh violated the state ’ s M edical Practice Act, which prohibits breaching patient confidentialit y … in Illinois for including the names of former patients in a lawsuit. The physician, Mahesh Parikh, MD, sued the patients for defamation over their claims that he engaged in sexual misconduct with them. As a part of his suit, he requested an injunction against the patients. The Illinois Department of Financial and Professional Regulation contends that Dr. Parikh violated the state’s Medical Practice Act, which prohibits breaching patient confidentiality and protects those who contact regulators under the act from civil liability. Dr. Parikh is subject to indefinite suspension of his license as a result of the sexual misconduct claims. Possible penalties for violating the Medical Practice Act include fines of $10,000 for each violation. n Source: Council on Licensure, Enforcement and Regulation Blog, July 2013; Chicago Tribune, August 12, 2013 ............................... Iowa Appeals Court Upholds Discipline of Surgeon for Unethical Conduct The Iowa Court of Appeals recently affirmed the Iowa Board of Medicine’s discipline of a University of Iowa Hospitals and Clinics physician for engaging in unethical conduct in the practice of medicine more than a decade earlier. The ruling was made in a disciplinary action against Adel S. Al-Jurf, MD, who was publicly reprimanded by the board and placed on probation for three years. The board charged him in 2009 with engaging in a pattern of unprofessional conduct, for which he had been terminated by the University of Iowa Hospitals and Clinics. Dr. Al-Jurf appealed the board’s decision, challenging the board’s authority to prosecute him for unethical conduct. He also contended that the board had inappropriately issued a news release about the disciplinary matter. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 27 S TAT E M E M B E R B O A R D B R I E F S continued The Appeals Court, in upholding a lower court ruling, said the board’s “interpretation of ‘unethical The A ppeals C ourt … said the board ’ s ‘interpretation of unethical conduct was not illogical or wholly unj ustified ’ conduct’ was not illogical or wholly unjustified” and that the board had not exceeded its authority in issuing a press release. n Source: Iowa Board of Medicine news release, July 30, 2013 ............................... Physician Assistants: Legislators amended Kentucky state law to give the supervising physician or the credentialing facility oversight of the physician assistant non-separate location practice. Legislators also reduced the waiting period before a newly graduated physician assistant may practice in a separate location from 18 months to three months and makes the three-month waiting period effective until May 31, 2014. After that date, the three continuous months of experience in a non-separate location will no longer be required for a physician assistant to practice at a separate location. Athletic Trainers: Kentucky law has been amended to require licensure rather than certification for authorized practice by athletic trainers. Athletic trainers in the state will receive wallet cards and wall certificates from the board. n Kentucky General Assembly Passes Several Bills Affecting Kentucky Physicians The Kentucky General Assembly approved several pieces of legislation during its 2013 session that impact physicians and other health care providers in the state. Among them: Naloxone Prescribing: Under new statutory language, physicians are not subject to disciplinary or any other adverse action by the Kentucky Board of Medical Licensure for their acts or omissions prescribing Naloxone either directly or by standing L egislators amended K entuck y state law to give the supervising physician or the credentialing facilit y oversight of the ph ysician assistant non -separate location practice. order if the physician acts in good faith and if, in the physician’s judgment, the patient is capable of administering the drug in emergency opioid overdose situations. 28 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 Source: Kentucky Board of Medical Licensure Newsletter, Summer 2013 ............................... Nevada Legislation in Nevada Extends Full Practice Authority to Advance Practice Nurses New legislation passed in Nevada significantly changed the practice requirements of Advanced Practitioners of Nursing (APNs) in Nevada. The new laws became effective on July 1, 2013. Assembly Bill (AB) 170 changed several aspects of regulation for APNs in Nevada. The title of the APNs in the state has been changed to Advanced Practice Registered Nurse (APRN) and the certificate of recognition that the Nevada State Board of Nursing (NSBN) has in the past issued to APNs has been changed to an APRN license. The new legislation also deletes the regulatory practice requirement for a formal, written collaborative agreement between the APRN and a physician, unless the ARPN has clinically practiced less than two years or 2,000 hours and intends ............................... to prescribe Schedule II Controlled Substances. In this case, the APRN must have a written collaborative agreement to prescribe those drugs until the clinical practice requirement is met. Virginia The Nevada Advanced Practice Nurses Association, whose members include more than 50% of the licensed APRNs in Nevada, advocated for Legislators in Virginia have passed new laws impacting the administration of oxygen by nurses and sexual boundary violations by physicians. With the adoption of A B 1 7 0 , N evada joined 2 4 other states in allow ing ARP N s full practice authorit y. the bill. With the adoption of AB 170, Nevada joined 24 other states in allowing ARPNs full practice authority. n Source: Nevada State Board of Medical Examiners Newsletter, August 2013 ............................... Ohio State Medical Board of Ohio Names Executive Director Aaron E. Haslam, JD, has been named executive director of the State Medical Board of Ohio. Since February 2011, Haslam has worked with Ohio Attorney General Mike DeWine as a senior assistant attorney general and chief of the Attorney General’s Prescription Drug Abuse Initiative. He has also served as coordinator for the state’s Special Prosecutions– Prescription Drug Unit. Halam served previously as the Adams County Prosecuting Attorney. Virginia Passes New Regulations Impacting Physicians and Nurses An amendment to the state’s Drug Control Act will now allow a prescriber to make oxygen available to registered and licensed practical nurses to possess and administer in emergency medical situations. Authorization is granted “pursuant to an oral or written order or standing protocol issued by the prescriber within the course of his professional practice.” Virginia has also passed a bill into law that provides for a five-year period of revocation when the Board of Medicine revokes a practitioner’s license for a sexual boundary violation. The new law stipulates that when the practice privileges of any person certified, registered or licensed by one of the state’s health regulatory boards have been revoked for a five-year period based on sexual misconduct, the board “shall conduct an investigation and review an application for reinstatement after revocation to determine whether there are causes for denial of the application. The reinstatement of a certificate, registration or license shall require the affirmative vote of threefourths of the members at a meeting. n Source: Virginia Board of Medicine Newsletter, #72, accessed September 2013. He earned his law degree from Cleveland-Marshall College of Law and is admitted to practice law in Ohio and the United States District Courts of Ohio. Haslam’s appointment was approved effective July 1, 2013. n Source: State Medical Board of Ohio news release, June 14, 2013 J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 29 I N T E R N AT I O N A L B R I E F S ............................... United Kingdom UK Processes More Than 7,600 Applicants in First Six Months of Revalidation The United Kingdom’s General Medical Council (GMC) reported recently that it had processed the applications of 7,663 physicians during the first six months of its new revalidation system. According to the GMC, at least 30,000 will revalidate by the end of the year. prepared by IAMRA’s Physician Exchange Working Group as a follow-up to a resolution adopted by IAMRA’s Members General Assembly during its bi-annual meeting in 2012 in Ottawa, Canada. The purpose of the guidance document, according to IAMRA, is to protect patients and the public from those physicians whose practice may put them at risk, ensure a high level of quality in health care around the world and ensure the public’s confidence in medical professionals and their regulation. The UK revalidation system requires physicians to demonstrate their ongoing engagement in efforts to keep their skills and knowledge up to date. The system was adopted last year after many years of development. All of the UK’s more than 230,000 physicians are impacted by the new system. The GMC’s goal is to have the majority of practicing physicians in the UK revalidated for the first time by 2016. The statement offers guidance for the circumstances in which disciplinary information about physicians should be exchanged — including situations involving criminal behavior, Revalidation in the UK is based on an annual appraisal in which physicians gather information about their practice, including complaints from patients, for examination by review officers. The UK is the first country in the world to introduce a system of ongoing physician review across its entire health care system. Other countries are developing similar systems, including the United States, where a proposed maintenance of licensure system would require physicians to demonstrate their engagement in continuous professional development as a condition of license renewal. n of information in multi- language Source: Council on Licensure, Enforcement and Regulation Blog, July 2013 ............................... International Organizations IAMRA Adopts Standards for Sharing of Information Worldwide The International Association of Medical Regulatory Authorities (IAMRA) has adopted the Statement of Intent on Proactive Information Sharing, providing guidance for the exchange of disciplinary information about physicians worldwide. The statement was 30 | J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 T he Statement provides a framework for protecting privacy and due process for physicians, for transmission settings and for timing of release of information . professional misconduct, professional incompetence or poor performance — and the way information should be exchanged. It also covers restrictions imposed as a result of impaired fitness to practice by reason of ill health. The statement provides a framework for protecting privacy and due process for physicians, for transmission of information in multi-language settings and for timing of release of information. Among its recommendations, the statement suggests that medical regulatory authorities should not release disciplinary information about physicians if no final decision has been taken because the case is still under investigation, a temporary sanction has been imposed pending a final decision or the physician has appealed the decision against him or her. n Source: IAMRA website (www.iamra.com), August 2013 I N F O R M AT I O N F O R A U T H O R S The Journal accepts original manuscripts for consideration of publication in the Journal of Medical Regulation. The Journal is a peer-reviewed journal, and all manuscripts are reviewed by Editorial Committee members prior to publication. (The review process can take up to eight weeks.) Manuscripts should focus on issues of medical licensure and discipline or related topics of education, examination, postgraduate training, ethics, peer review, quality assurance and public safety. Queries and manuscripts should be sent by email to [email protected] or by mail to: Editor Journal of Medical Regulation Federation of State Medical Boards 400 Fuller Wiser Rd., Suite 300, Euless, TX 76039 Manuscripts should be prepared according to the following guidelines: 1. An email or letter should introduce the manuscript, name a corresponding author and include full address, phone, fax and email information. The email or letter should disclose any financial obligations or conflicts of interest related to the information to be published. 5. Any table or figure from another source must be referenced. Any photos should be marked by label on the reverse side and “up” direction noted. Tables and figures can be supplied in EPS, TIF, Illustrator, Photoshop (300 dpi or better) or Microsoft PowerPoint format. 6. The number of references should be appropriate to the length of the text, and references should appear as endnotes, rather than footnotes. 7. Commentary, letters to the editor and reviews are accepted for publication. Such submissions and references should be concise and conform to the format of longer submissions. 8. If sent by mail, a PC- or Mac OS-compatible CD-ROM should accompany a printed copy of the manuscript. Microsoft Word format is the preferred file format. 9. Manuscripts are reviewed in confidence. Only major editorial changes will be submitted to the corresponding author for approval. The original manuscript and CD-ROM will be returned if the submission is not accepted for publication only if a SASE is supplied with sufficient postage. 2. The title page should contain only the title of the manuscript. A separate list of all authors should include full names, degrees, titles and affiliations. 3. The manuscript pages should be numbered, and length should be between 2,750 and 5,000 words, with references and tables attached. Please ensure that references adhere to the AMA Manual of Style. For more information, visit www.amamanualofstyle.com. 4. The manuscript should include an abstract of 200 words or less that describes the purpose of the article, the main finding(s) and conclusion. Footnotes or references should not be included in the abstract. J O U R N A L of M E D I C A L R E G U L AT I O N VO L 9 9 , N O 3 | 31 “Reducing the risk of addiction, abuse and diversion of opioids” NOW AVA as a ILA n eB BLE ook! Scott M. Fishman, MD A Vital CME Resource for Prescribers A revised and expanded version of Responsible Opioid Prescribing™: A Clinician’s Guide is now available, in both print and electronic formats. Responsible Opioid Prescribing™: A Clinician’s Guide offers clinicians effective strategies for reducing the risk of addiction, abuse and diversion of opioids that they prescribe for their patients in pain. Written by pain medicine specialist Scott M. Fishman, MD, this revised and expanded edition offers important new material, including research on opioid prescribing and updated recommendations for prescribers. • V isit our easy-order web page for purchase and download of the new eBook version: www.fsmb.org/book. • Published by Waterford Life Sciences • Available in ePub, Kindle/mobi and Apple iBooks formats • $16.95 • Certified for up to 7.25 AMA PRA Category 1 Credits™, University of Nebraska Medical Center FSC promotes well-managed forests through credible certification that is environmentally responsible and economically viable. Paper used for this journal is certfied to be environmentally friendly and 100% recyclable. Federation of State Medical Boards 400 Fuller Wiser Road, Suite 300 Euless, TX 76039