MDAdvisor Spring 2016 by MDAdvantage Insurance Company of New Jersey

Daniel G. Giaquinto, Esq.

CAREER JEOPARDY FOR IMPROPER PRESCRIBING OF CONTROLLED SUBSTANCES

CME Acting Commissioner Cathleen D. Bennett & Chris Rodriguez, PhD

SHARING INTELLIGENCE IN AN INTERCONNECTED WORLD

PERSPECTIVES ON HEALTHCARE FROM THE 2016 EDWARD J. ILL EXCELLENCE IN MEDICINE HONOREES

Susan E. Skochelak, MD, MPH, David E. Swee, MD, & Victoria Stagg Elliott, MA

BUILDING THE MEDICAL SCHOOL OF THE FUTURE: WORKING WITH THE AMA ACCELERATING CHANGE IN MEDICAL EDUCATION INITIATIVE

VOLUME 9 • ISSUE 2 • SPRING 2016

Excellence Personified

Meet the 2016 Edward J. Ill Excellence in Medicine Awards® Recipients

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Now you know… MDAdvantage WE PROVIDE VALUE BEYOND INSURANCE. At MDAdvantage®, our mission is to be a haven of safety, stability and strength for New Jersey healthcare. We advocate for physicians and actively support the practice of medicine in New Jersey. We have earned a reputation for integrity, responsiveness and decisive management, and stand prepared to assist healthcare providers in facing the challenges associated with today’s changing healthcare environment.

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TE N A OST C . A

ing grow nt e h t fica on igni ses s u r c o ls, f le f o artic te leve ez, E M rigu t ta y. t C s d i s o t d s tes an ce is R bou Chr ur la ederal dical ne on a . i r O t . D a f r me orm r. the v is o and and t inf ett o DAd i a n s , a t n re g n a n M t n i r sect o c Be of rib lthca i p e c a s r n s e y e m a i e e u iss us lue lthc hle f ph per pr he h Cat ring the hea act on t on B ll ring tions o z ro r b i p r p , e S y o f n u he yH ng urit sio imp vera ts o sec to t Sec mis hitti ed b d the o d p ro cted men r e y d m l l e e e j n f r o m g a i f a o C r o in co asin mel ls an dent an requ ealth ts p lan Wel of crim pita f Ho re incre et and i ealth p the H s n o o g m d e h a c epe ier 2 tren ions fro y, Actin udg ed h Offi es that from lity ind r b T y e i n e t e t l t o l d ia Jers breach qua NIA ositi e sta iona bele low dev h y p t w M a t i l n p e d a O o w Ad ata fol eN ,m een the ollo vere plan have b inue to of th ts and d losely f t of t se c r A e a I o t p t c f m N c n s are l the tinue to Dire l co lthc ial im ich has the OM ysician l t a i a t n i e w e g h h di ph d con We pot der y, w the tice s an me and also l as the ces. . Un erse c y n J n a e a r e i s w We l o sic Jer we te p onsequ -inc f Ne phy riva t, as low c New ld o p m e t e r n n i k i r i n a r h y S ma fica erio ose o h unit lue sup er signi ial t cially th t mm ss B d n ard o o n r e c f C ot pe re s a suf Edw l p s a a e c 6 o t t e i , h 1 lt th 20 res ely osp hea the ssue losu e lik hat has ic h c r l e a z o i e his i h c n t d t i t t f g n a c a o o e C u s ec pra ver tly ider tant iss to r e co loquen d ause h c u r t prov o o n r e s on eve i mp ies. mp ient es who t of all, unit ote, I a and this p i s m c r s e re ide com itive n nor , mo ard o d w prov erved h n s a s. A the e po cine ers field edicine om mor n Medi und r e f a v i i On in M mns respect nce nce elle colu e e r l i c l x e e e E th t th xc ud n f E l e o c 6 s J. Ill n 1 e r 20 to i e future repr e you rt ou h ey and t o h t p e hop 6 p crib , as o su re. I t s 01 a t des c d n e 2 lth de rou h a u t p t e s h I am rship ey ting , as Jers gratula and r ola s w t h e n c e e S fN con cipi nsid re o e in ship re ear, co m futu ore r or m e join xt y hola F e l c . l n s i 7 u w d 01 to is iss or 2 h ad d an f t r e f n a h o aw k a ver o .com. nati thin k co omi c n u ne a a o b y onli ing he e t t t g i e a t subm ation, se Advan D m r M info ww. isit w v r o y, erel Sinc

ICIA R T F PA O ESK D T HE M FRO

any omp C O E e &C ranc man ge Insu r i a Ch anta Adv D M

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Natalya Andriyanycheva Rutgers School of Health Related Professions (2017) Ryan Miller Cooper Medical School of Rowan University (2018) Ronak Mistry Rowan University School of Osteopathic Medicine (2017) Rachel Morales Rutgers New Jersey Medical School (2016) Richard Steinwandtner Seton Hall University School of Health and Medical Sciences (2017) Melissa Villars Rutgers Robert Wood Johnson Medical School (2016) Nicole Viola Rutgers School of Dental Medicine (2017) The Advisory Committee advises the Publishing Staff and Editorial Board on topics, themes and invited papers for future issues of MDAdvisor that address the issues impacting young healthcare providers. Look for columns from Advisory Committee members that provide insights into their experiences throughout their education and training in upcoming issues.

WHAT’S HAPPENING IN HEALTHCARE? 2017 Fiscal Budget Seeks $1.1 Billion to Fight Opioid Abuse President Obama’s fiscal 2017 budget includes $1.1 billion to combat opioid abuse, with a focus on medication-assisted treatment. The bulk of the money would fund state programs in an effort to make treatment more available and easier to afford. States with higher rates of opioid abuse and strong plans for addressing it will get more funding. Physicians Question Whether CMS’ Part B Drug Proposal Usurps Clinical Judgment, Cripples Specialists Medicare’s overhaul of the way it reimburses doctors for more than $20 billion worth of outpatient drugs they administer each year has drawn criticism from physicians. While CMS states the proposal does not affect patient care, critics argue it is another example of the government usurping the physicians’ role.

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NEWS & ACKNOWLEDGEMENTS

ANNOUNCING THE NEWEST MEMBERS OF OUR EMERGING MEDICAL LEADERS ADVISORY COMMITTEE:

A Journal for the Healthcare Community PUBLISHER PATRICIA A. COSTANTE, FACHE Chairman & CEO MDAdvantage Insurance Company PUBLISHING & BUSINESS STAFF CATHERINE E. WILLIAMS Senior Vice President MDAdvantage Insurance Company JANET S. PURO Vice President MDAdvantage Insurance Company THERESA FOY DIGERONIMO Copy Editor MORBELLI RUSSO & PARTNERS ADVERTISING INC. EDITORIAL BOARD PAUL J. HIRSCH, MD, Editor-in-Chief HON. PAUL W. ARMSTRONG, JSC (Ret.) STEVE ADUBATO, PHD RAYMOND H. BATEMAN PETE CAMMARANO DONALD M. CHERVENAK, MD STUART D. COOK, MD VINCENT A. DEBARI, PHD JEREMY S. HIRSCH, MPAP WILLIAM G. HYNCIK, ATC JOHN ZEN JACKSON, ESQ. ALAN J. LIPPMAN, MD JUDITH M. PERSICHILLI, RN, BSN, MA EMERGING MEDICAL LEADERS ADVISORY COMMITTEE NATALYA ANDRIYANYCHEVA RYAN MILLER RONAK MISTRY RACHEL MORALES

RICHARD STEINWANDTNER MELISSA VILLARS NICOLE VIOLA

PUBLISHED BY MDADVANTAGE INSURANCE COMPANY 100 Franklin Corner Road, Lawrenceville, NJ 08648-2104 www.MDAdvantageonline.com Phone: 888-355-5551 • Editor@MDAdvisorNJ.com INDEXED IN THE NATIONAL LIBRARY OF MEDICINE’S MEDLINE® DATABASE.

Material published in MDAdvisor represents only the opinions of the authors and does not reflect those of the editors, MDAdvantage Holdings, Inc., MDAdvantage Insurance Company and any affiliated companies (all as “MDAdvantage®”), their directors, officers or employees or the institutions with which the author is affiliated. Furthermore, no express or implied warranty or any representation of suitability of this published material is made by the editors, MDAdvantage®, their directors, officers or employees or institutions affiliated with the authors. The appearance of advertising in MDAdvisor is not a guarantee or endorsement of the product or service of the advertiser by MDAdvantage®. If MDAdvantage® ever endorses a product or program, that will be expressly noted. Letters to the editor are subject to editing and abridgment. MDAdvisor (ISSN: 1947-3613 (print); ISSN: 1937-0660 (online)) is published by MDAdvantage Insurance Company. Printed in the USA. Subscription price: $48 per year; $14 single copy. Copyright © 2016 by MDAdvantage®. POSTMASTER: Send address changes to MDAdvantage, 100 Franklin Corner Road, Lawrenceville, NJ 08648-2104. For advertising opportunities, please contact MDAdvantage at 888-355-5551.

MDADVISOR | SPRING 2016

LETTER FROM MDADVANTAGE® CHAIRMAN & CEO PATRICIA A. COSTANTE

BUILDING THE MEDICAL SCHOOL OF THE FUTURE: WORKING WITH THE AMA ACCELERATING CHANGE IN MEDICAL EDUCATION INITIATIVE | By Susan E. Skochelak, MD, MPH, David E. Swee, MD, & Victoria Stagg Elliott, MA

PERSPECTIVES ON HEALTHCARE FROM THE 2016 EDWARD J. ILL EXCELLENCE IN MEDICINE HONOREES | Edited by Janet S. Puro, MPH, MBA

CME

SPRING 2016 – CONTENTS

Front Row left to right: Sr. Breda Boyle; Anita Chopra, MD; Sara Cuccurullo, MD Back Row left to right: Sr. Kristin Funari; Barry H. Ostrowsky; Christopher O. Kosseff; Jean Anderson Eloy, MD Recipient not shown: Robert Korngold, PhD

CAREER JEOPARDY FOR IMPROPER PRESCRIBING OF CONTROLLED SUBSTANCES | By Daniel G. Giaquinto, Esq.

SHARING INTELLIGENCE IN AN INTERCONNECTED WORLD | By Acting Commissioner Cathleen D. Bennett & Chris Rodriguez, PhD

THE SIGNIFICANCE OF THE DECREASE IN CORONARY HEART DISEASE RATES | By William G. Rothstein, PhD

NEW JERSEY LEGISLATIVE UPDATE: GOVERNOR CHRISTIE’S PROPOSED FY17 BUDGET, HORIZON’S OMNIA PLAN & HEALTHCARE LEGISLATIVE BILLS | By Michael C. Schweder

THE LEGACY OF KAREN ANN QUINLAN 40 YEARS LATER | An Interview with Hon. Paul W. Armstrong, JSC (Ret.) By Steve Adubato, PhD, & Rafael Pi Roman

THE GREAT ABYSS | By Emily Weinick, PA-S

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Building the

Medical School of the Future: Working with the AMA Accelerating Change in Medical Education Initiative By Susan E. Skochelak, MD, MPH, David E. Swee, MD, & Victoria Stagg Elliott, MA The American Medical Association (AMA) launched its Accelerating Change in Medical Education initiative in 2013 with grants for medical school projects pursuing transformative change. Of the 141 MD degree–granting institutions eligible to apply in 2013, 119 submitted letters of intent. Eleven were awarded $1 million five-year grants1 and formed the Accelerating Change in Medical Education Consortium. In 2015, the AMA announced that the consortium would expand and issued a call for innovative medical education transformation projects that would enhance the consortium’s ongoing work. A total of 21 schools, both MD and DO degree–granting institutions, were each awarded three-year grants of $75,000 and were added to the consortium. The impact of this investment and ongoing collaboration has rippled through medical education, including New Jersey institutions. Rutgers Robert Wood Johnson Medical School was awarded a grant in the second round, and the schools that did not receive awards have also felt the effects of this initiative.2 This article analyzes the trends in the overall education system, medical education and the healthcare system that created the need for change and looks at how the AMA is acting as the catalyst for transforming med-

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ical education across the county. All medical schools are engaged in some degree of continuous curricular review and, in some cases, have recently implemented significant curricular changes. This article primarily focuses on the impact of the AMA’s work and some of the changes occurring within medical schools in New Jersey.

WHY MEDICAL EDUCATION NEEDS TO CHANGE The last major transformation of medical education was triggered by the Flexner Report, an outgrowth of the activity of the AMA’s Council on Medical Education, which was published in 1910. It was highly critical of the haphazard U.S. medical education system that existed at the time. A number of comparable reports followed, identifying similar problems and proposing related solutions, leading to the elimination of proprietary schools and the establishment of a four-year medical school curriculum, comprised of two years of basic sciences and two years of clinical teaching. Now, many years later, several notable entities are calling for medical education to once again reform significantly in response to medical and societal changes. The 2001 report Crossing the Quality Chasm: A New Health System for the 21st Century issued by the Institute of

Medicine (now known as the Health and Medicine Division (HMD) of the National Academies of Sciences, Engineering, and Medicine) stated that transforming medical education 3 was key to creating a modern healthcare system. Other organizations, including the AMA, the Pew Health Professions Commission, the Accreditation Council for Graduate Medical Education, the Association for American Medical Colleges and the Commonwealth Fund, have 4 reached similar conclusions. Most entities working on this issue report that medical education has not kept up with changes in the healthcare system, technology and society. The modern healthcare system is increasingly reliant on physicians’ ability to coordinate care, focus on prevention and consider healthcare costs. A survey of physicians under the age of

In New Jersey, Rutgers Robert Wood Johnson Medical School (RWJMS) was added to the consortium in 2015 based on its proposal to develop a value-added educational model built on interprofessional learner teams. These teams of medical students and those studying other health professions will work with clinicians and a care-coordination team in patients’ homes to advance the Triple Aim–improving the patient experience of care, improving population health and reducing per capita costs of healthcare–and to achieve educational goals in collaboration with a newly developed 8 accountable care organization (ACO).

HOW MEDICAL EDUCATION NEEDS TO CHANGE Although there is general agreement that medical education needs to change, more specificity on how it

“Most entities working on this issue report that medical education has not kept up with changes in the healthcare system, technology and society.”

45, however, found that, although the vast majority rated their medical education as excellent with regards to preparing them to practice medicine, only 32 percent said it prepared them to coordinate patient care with community and other resources. A larger percent said medical education prepared them to provide preventive care (60 percent), and 41 percent felt prepared to provide cost-effective care.5 Modern physicians also need to understand other important aspects of health systems science such as collaborating with large healthcare systems and using technology–skills that those authoring reports on medical education reform in the first half of the 20th century could not even imagine.6 Additionally, the education system as a whole in the United States is generally shifting away from “time in seat” to competencybased or personalized learning.7 Medical school administrators are aware of the need for change, and their interest in transformation is high. Of the 141 medical schools eligible to apply for an Accelerating Change in Medical Education grant in 2013, 119 (84 percent) submitted letters of intent to do so.1 Many that did not receive grants in the first round pursued other funding sources and continued developing their projects independently. Of the 170 MD and DO degree–granting institutions eligible to apply in the second round of funding in 2015, 108 (64 percent) submitted applications.2

should change is needed. The consortium has an evaluation plan in place to identify the most effective key components of a transformed medical education system emerging from funded projects. Examples of projects funded in 2013 include the following: • Indiana University School of Medicine is creating a virtual healthcare system and an electronic medical record designed for teaching to ensure students have competencies in system-, team- and population-based healthcare as well as in clinical decision-making. • Mayo Medical School is working closely with health system leaders to develop detailed educational models for each of the six sciences of healthcare delivery domains, creating an educational model to prepare students to practice within and lead patient-centered, community-oriented, science-driven collaborative-care teams that deliver high-value care. • New York University School of Medicine is creating the NYU Health Care by the Numbers Curriculum, a flexible, three-year, individualized, technology-enabled blended curriculum to improve care coordination and care quality. • Oregon Health & Science University School of Medicine is implementing a novel, learner-centered, competencybased curriculum, which enables students to advance through individualized learning plans as they achieve key milestones tracked in a personal portfolio.

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• Penn State College of Medicine is collaborating with the leaders of affiliated health systems to create its Systems Navigation Curriculum. This curriculum combines a course in the science of health systems with an immersive experience as a patient navigator. • The Brody School of Medicine at East Carolina University is establishing a comprehensive, longitudinal core curriculum in patient safety, quality improvement, population health and team-based care and integrating components of the curriculum with other health-related disciplines to foster interprofessional skills and to prepare students to successfully lead healthcare teams. • The Warren Alpert Medical School of Brown University is developing an MD/ScM degree program in primary care and population medicine that seamlessly integrates the third medical science (health systems science) with the first (basic science) and the second (clinical science) over the four years of medical school. • University of California, Davis, School of Medicine is establishing a six-year, competency-based, undergraduate medical education/graduate medical education pathway linked to residency programs run by Kaiser Permanente Northern California and University of California, Davis. • University of California, San Francisco, School of Medicine has established its Bridges Curriculum, which is crafted to allow students to contribute to improving healthcare outcomes while in school and to be educated to work within complex systems. • University of Michigan Medical School is transforming its entire healthcare curriculum in order to graduate physician leaders and change agents who will improve healthcare at the system and patient level. • Vanderbilt University School of Medicine is creating master adaptive learners–physicians who will learn, engage in guided self-assessment and adapt to the evolving needs of their patients and the healthcare system throughout their careers.1 The projects of the 21 schools recently added to the consortium complement and enhance these projects. For example, as previously mentioned, the project at RWJMS involves incorporating medical students and other health-profession learners into care-coordination teams of the Robert Wood Johnson Partners ACO in order to augment care for patients with multiple chronic conditions and to maximize integrated care delivery in the home setting.8

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IMPACT BEYOND THE MEMBERS OF THE ACCELERATING CHANGE IN MEDICAL EDUCATION CONSORTIUM The consortium has grown to 32 schools that are educating 19,000 medical students–18 percent of all U.S. allopathic and osteopathic medical students. The impact of the consortium, however, goes beyond member schools, and the consortium has numerous opportunities for non-member schools, many of which are pursuing their own curricular transformation, to benefit from consortium work. For example, the consortium holds a biennial conference, ChangeMedEd, which brings together members and non-members, including leaders from medical education, health systems and related fields, to transform the way future physicians 1 are trained. ChangeMedEd 2015 attracted more than 350 attendees from 128 organizations. Periodic thematic meetings, such as a learning technology conference in Austin, Texas, in December 2014, have involved subject matter experts from numerous schools. The meeting in Austin gathered leaders from 20 medical schools, including University of Texas system educational leaders. Information about consortium work and innovations has been presented at local, national and international meetings and published widely. Consortium members have made several presentations at meetings of the Association of American Medical Colleges, the Association for Hospital Medical Education, as well as several other organizations. Papers have been published in Academic Medicine, Medical Education and several other peer-reviewed publications. Consortium member schools also are in regular contact with non-member schools in their regions, and some have developed tools that are already available for wider use. For instance, New York University School of Medicine has developed a web-based tool using real clinical data from the New York State Department of Health Statewide Planning and Research Cooperative System that incorporates almost five million de-identified patient-level records. These de-identified data create a virtual multipractice care group that students can analyze to understand the fundamentals of measuring quality and value. The technology infrastructure for this tool is available at the NYU-hosted website: http://education.med.nyu.edu/ace/sparcs. New Jersey medical schools also have been making great efforts to respond to the changing healthcare environment. The new school in Camden, Cooper Medical

School of Rowan University, has a commitment to providing medical education that is tied to community service. The school’s longitudinal integrated clerkship is the basis for all the third-year medical students’ clinical experiences. RWJMS has a patient-centered medicine (PCM) curriculum that stretches through all four years, involves students in small group discussions and simulations and allows students to experience interprofessional education in various settings. The school is an early affiliate of the Alan Alda Center for Communicating Science and has integrated innovative ways of teaching communication skills into the PCM curriculum. RWJMS has a new curriculum that has adopted many modern trends, including organ-based system education, early integrated clinical practice of medicine skills, service learning and individual professional identity development with a healthcare team focus.

Institute of Medicine. Committee on Quality Healthcare in America. (2001, March). Crossing the quality chasm: A new health system for the 21st century. http://iom.nationalacademies.org/~/media/Files/Report%20Files/2001/Crossing-theQuality-Chasm/Quality%20Chasm%202001%20%20 report%20brief.pdf.

Skochelak, S. (2010, September). A decade of reports calling for change in medical education: What do they say? Academic Medicine, 85(9 Suppl), S26–33.

Cantor, J. C., Baker, L. C., & Hughes, R. G. (1993, September 1). Preparedness for practice: Young physicians’ views of their professional education. JAMA, 270(9),1035–1040.

American Medical Association. (July 2015). Accelerating change in medical education. https://download.ama-assn.org/ resources/doc/about-ama/x-pub/ace-monograph-interactive.pdf.

U.S. Department of Education. (n.d.). Competency-based learning or personalized learning. www.ed.gov/oii-news/ competency-based-learning-or-personalized-learning.

American Medical Association. (2016). Consortium schools. www.ama-assn.org/ama/pub/about-ama/strategic-focus/ accelerating-change-in-medical-education/schools.page.

CONCLUSION The Accelerating Change in Medical Education Consortium is harnessing the significant desire for change that exists within the medical education system, society and the healthcare system and turning it into meaningful action that goes beyond the initial 11 grant recipients and the 21 schools added in 2015. Patients should be cared for in 21st century medical facilities by physicians trained by 21st century educational strategies in the skills needed in the modern world. They should accept nothing less. Susan E. Skochelak, MD, MPH, is Group Vice President for Medical Education at the American Medical Association; David E. Swee, MD, is Associate Dean for Faculty Affairs and Development, Associate Dean for Education and Professor of Family Medicine and Community Health, Rutgers Robert Wood Johnson Medical School; Victoria Stagg Elliott, MA, is Technical Writer in Medical Education at the American Medical Association. 1

American Medical Association. (2013, June 14). AMA awards $11M to transform the way future physicians are trained. www.marketwired.com/press-release/ama-awards-11mto-transform-the-way-future-physicians-are-trained1801961.htm.

American Medical Association. (2015, November 4). 21 more schools tapped to transform physician training. AMA Wire. www.ama-assn.org/ama/ama-wire/post/20schools-tapped-transform-physician-training.

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Edited by Janet S. Puro, MPH, MBA The 2016 Edward J. Ill Excellence in Medicine honorees are all distinguished healthcare professionals who, each day, face with courage and conviction the challenges of modern medicine. They stand out as leaders who have earned the admiration and respect of their peers as they faithfully provide quality care to patients and consistently strive to challenge themselves and their medical fields to improve the status quo. We have asked each one to consider the future of their respective fields and to discuss the greatest challenges they face. Their answers give us a unique opportunity to better understand the work, as well as the concerns and the hopes, of these remarkable and diverse leaders in healthcare.

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Outstanding Medical Educator Award Sara Cuccurullo, MD Medical Director and Vice President, JFK Johnson Rehabilitation Institute; Clinical Professor and Chairman, Residency Program Director, Rutgers Robert Wood Johnson Medical School Educating medical students, residents and fellows is one of the most important responsibilities one can have. It ensures the future of medicine. These students have an energy that inspires all those around them who are part of the educational process that results in superior clinical care for patients and research collaboration. I have been a Residency Program Director for more than 17 years and Chairman and Medical Director for two years at the JFK Johnson Rehabilitation Institute (JRI). Over that time, I have seen how there has been a major shift in healthcare and how that shift has necessitated a shift in the preparation of these future physicians. These students have challenges. These challenges include significant educational debt and becoming well versed in the proper practices of billing, coding and practice management. In addition, students must be trained to shift their focus to what is on the horizon for population health. Gone are the days of the physician working at his or her own pace. Now the focus is on treating the patient as accurately and efficiently as possible and keeping that patient, once discharged, healthy and out in the community. Physicians must also advocate for the patient more than ever for health insurance appeals to render necessary treatments. In addition, resident and fellowship training now focuses heavily on the quality of patient care and patient safety. As a result, the education of these students at the JFK JRI includes a comprehensive education in not only medical knowledge and clinical practice but also in personal debt management, proper billing and coding practices and practice management. We also train our learners in population health, with a focus on delivering quality clinical care in the most efficient way possible. We have initiated comprehensive aftercare, stroke recovery and cardiopulmonary programs for all our discharged rehabilitation patients. These programs keep our patients healthy and out in the community. The residents are trained in these practices and the benefits

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linked to them. We also train residents and fellows to advocate for patients by communicating with insurance companies for necessary treatments. Students participate in quality improvement and safety projects and training annually. By preparing these students for the future of healthcare, we can best ensure their success for a full and rewarding career in medicine. By doing so, we all will benefit.

Outstanding Healthcare Executive Award Barry H. Ostrowsky President and CEO, RWJBarnabas Health Throughout the United States, the treatment of chronic, often preventable, health conditionsâ&#x20AC;&#x201C;such as heart disease, diabetes and obesityâ&#x20AC;&#x201C;annually totals hundreds of billions of dollars. At RWJBarnabas Health, New Jerseyâ&#x20AC;&#x2122;s largest healthcare system, we believe our major responsibility is to drive the paradigm shift towards better health. To improve the well-being of our communities, our mission has changed and now includes reaching beyond providing expert care when people are sick and extends to keeping people well. RWJBarnabas Health is leading this transformation through a focus on preventive medicine. Beyond our hospital campuses and outpatient facilities, we are reaching out into the communities, establishing a presence where people work and live, through a broad network of

Edward J. Ill Physician’s Award® Jean Anderson Eloy, MD Professor and Vice Chair, Department of Otolaryngology, Head and Neck Surgery; Professor, Department of Neurological Surgery; and Professor, Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School

human, social and health services. Within the next five years, population health management will require hospitals and hospital systems to be responsible for hundreds of thousands of people, keeping them well, caring for them when they are not and helping them live healthy lives. In addition to health needs, population health management will require assessment of social and cultural determinants that can impact a person’s overall health, such as food, housing and medication management. This is a vastly different approach from the focus of hospitals and healthcare in the past. RWJBarnabas Health continues to be recognized locally and nationally for important community initiatives, including weight-loss education, concussion and cardiac screenings, a partnership with Special Olympics New Jersey and a strong emphasis on programs of cultural competence, diversity and equity, which have garnered state-wide and national awards. We are encouraging our communities to value their health and become motivated to exercise, make healthy dietary choices, get annual physicals and flu shots and manage their medications. By integrating with our communities to improve their quality of life, we will dramatically change behavior and make a positive and lasting impact on the health of New Jersey.

Some of the greatest challenges I have faced have involved specific and personal situations taking care of patients. One of the greatest challenges I had to face as a healthcare provider (specifically as a surgeon) occurred after a highly complex surgery in which intraoperatively everything was technically perfect, yet the patient awoke with one of the most dreadful complications related to the specific case. What followed was one of the hardest months of my life, when every medical decision made to address one issue for this patient led to another dreadful event. My first attempt was to treat this patient’s condition in the most evidencebased approach possible. This approach, unfortunately, failed. I then consulted my mentors, to determine whether they would change my chosen course of treatment based on their collective experience. Unfortunately, the steps taken from these discussions did not significantly change the medical course of my patient. During this time, I remember sitting with this highly intelligent and insightful patient for a one-on-one discussion about his care. Despite all that happened, he continued to entrust me with his care and seemed more concerned about my mental well-being and my “suffering” during this process. He displayed immense compassion and understanding for what I was going through and he taught me the true meaning of compassion in the doctor-patient relationship. Fortunately, this patient eventually did well and recovered from these setbacks, but the experience remains with me today. It is from the most challenging and difficult medical situations that I have learned the most about who I am as a physician and human being.

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Verice M. Mason Community Service Leader Award Christopher O. Kosseff, President and CEO (retired), on behalf of Rutgers University Behavioral Health Care As the cost of healthcare in the United States continues to escalate, new strategies for containment will be proposed, and some will be tested. Short of having a glimpse of the future, it is impossible to know with certainty how healthcare funding will be structured even five years from now. We can all recall numerous “solutions” that have come and gone. This, of course, makes preparation for the future a risky business. Guess wrong, and you may steer your organization into oblivion. You do not want to be at the forefront of a new trend that fizzles. On the other hand, staunch defense of the status quo is foolhardy, given the growing percentage of the gross domestic product (GDP) consumed by healthcare. The United States spends about 25 percent more per capita on healthcare than the next most expensive country. Change is bound to come–and it is unlikely to be in the form of reduced regulatory requirements that have consistently driven up our cost of care and added little to improved outcomes. These requirements seem only to escalate. So, the question is, how do we best prepare our organizations for the unknown? A favorite quote by Abraham Lincoln seems to make sense in our healthcare environment: “Give me six hours to chop down a tree, and I will spend the first four sharpening the axe.” The sharpening for us should be in the form of building added value into our services. Crafting improved outcomes

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with better control of costs seems the best strategy for positioning our organizations for new cost containment strategies, no matter what form they may take. Some of these challenges are exaggerated in behavioral health, given the very low margins and lack of “procedures.” In outpatient settings, we are simply selling professional time. Although the efficacy of care can always be improved, the vast majority of the cost resides in the professional time. This is, at least, part of the reason that behavioral healthcare has seen such a growth in non-medical providers. Behavioral healthcare, therefore, must focus on improved outcomes and, to a lesser extent, more efficient service delivery strategies. It is possible to prepare for the future, but it is best done by improving the value of care and not banking on the specific structure of change.

Outstanding Scientist Award Robert Korngold, PhD Chairman, Department of Research and Chief, Basic Research Division, at the John Theurer Cancer Center, and Senior Scientist at the David and Alice Jurist Institute for Research at Hackensack University Medical Center My laboratory is focused on the immunobiology of T cells responsible for graft-versus-host disease and graft-versus-tumor responses following allogeneic hematopoietic cell transplantation commonly used to treat patients with hematological malignancies. We are currently developing a T cell engineering immunotherapy approach for cancer. T cells are very capable of eliminating cancer cells if they can recognize specific target antigens and are allowed to function in the tumor microenvironment. T cells can recognize small peptide breakdown products from proteins produced within a tumor cell that may be unique to that tumor and, therefore, not, or minimally, expressed in normal cells. As a result, there would be limited damage to other tissues and much less treatment toxicity than with many drugs or with the use of antibodies or chimeric antigen receptor T cells directed against

Peter W. Rodino, Jr., Citizen’s Award® Anita Chopra, MD Director, New Jersey Institute for Successful Aging, and Professor and Chair of the Department of Geriatrics and Gerontology and William G. Rohrer Endowed Chair in Geriatrics at Rowan University School of Osteopathic Medicine Our aging nation presents an unprecedented challenge. Some characterize this as the “silver tsunami.” According to the U.S. Department of Health and Human Services’ Administration on Aging, in 2013 there were 44.7 million individuals age 65 and older in the United States–or about 1 in 7. By 2060, those numbers will more than double to 94 million or more than 1 in 5. More dramatically, the 85-and-

surface molecules that tend not to be unique to tumor cells. Next-generation DNA sequencing technology now allows us to analyze T cell responses to tumor cells and precisely identify expanding clones of T cells with T cell receptors that are specific to tumor antigens in individual patients. This approach could potentially be applied to a wide variety of cancers, including hematological malignancies, such as non-Hodgkins lymphomas, leukemia and multiple myeloma, as well as solid tumors, such as melanoma, lung and breast cancers. We would then construct copies of those anti-tumor T cell receptors to transform a large number of normal T cells, from either the patient or donor, to enable them to attack the tumor cells and eradicate the disease in the patient. This type of immunotherapeutic approach would best be utilized after cytoreductive therapy to eradicate the bulk of the tumor and an autologous or allogeneic hematopoietic cell transplant. To further enhance the ability of these specific T cells to target and kill tumor cell targets, this approach could also be combined with checkpoint inhibitors, which help block the ability of tumor cells to evade the immune system. Our work is under way toward this adaptive form of precision medicine that could benefit individual patients as well as potentially multiple patients with the same types of diseases.

older segment will triple from 5.9 million to 18.2 million. As people age, their health needs tend to become more chronic and complex. More than two-thirds of older adults have multiple chronic conditions–some as many as six. When a chronic condition is accompanied by functional or cognitive impairment, Medicare costs can double or quadruple. National health expenditures in 2013 were $3 trillion, with the 65+ group accounting for the greatest expenditures. Yet the Commonwealth Fund reports that among 13 high-income countries, the United States has poorer health outcomes, including shorter life expectancy and greater prevalence of chronic conditions, despite spending more on healthcare. Older adults currently receive their healthcare in a fragmented and disconnected way, which not only fails to adequately meet their needs but can also have great costs for them and the health system. The medical community can advocate for older adults by helping to redesign health systems that provide age-friendly, older-person-centered, integrated care. This type of care will require a comprehensive patient assessment that includes a complete review of all medical, psychosocial, lifestyle and value issues; creation and implementation of a care plan that addresses all of the patient’s healthcare needs; communication and coordination with all who provide care for the patient; and promotion of the patient’s engagement in his or her own healthcare. Existing models that provide coordinated, patientcentered care have shown that this approach produces better outcomes without increasing costs. These new systems will need an appropriately trained healthcare workforce that understands geriatric/gerontological issues, respects the diverse professions engaged in caring for older adults and demonstrates skills in interprofessional teamwork and communication. Older adults at the end of their lives want to die as pain free as possible, at home with family present and to have their wishes honored. However, many older adults are not allowed to die with dignity and in comfort. The medical community can play a very important role in raising awareness of the value of end-of-life care planning and providing appropriate guidance and information to patients and their families. Last, efforts must be made at the societal level to combat ageism: its prejudicial attitudes toward aging, negative stereotypes that equate aging with deterioration and impairment and generalizations that all older adults are alike. Tackling ageism will require embedding in the thinking of all generations a new understanding of aging and rejecting outdated assumptions.

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Special Award A Special Award is being presented this year to the Congregation of the Sisters of St. Joseph of Peace (CSJP), the founders and sponsors of Holy Name Medical Center, among numerous sponsored ministries and missions, for their service as champions of the underserved, the poor, the sick, immigrants and the powerless, in New Jersey and beyond. A healthcare ministry has been central to the work of the Congregation of the Sisters of Saint Joseph of Peace (CSJP) since the order was founded in 1884 in Nottingham, England, by Margaret Anna Cusack. Deeply moved by the suffering of poor and oppressed people, she led the congregation in promoting the peace of the Church by word and work, providing not only care but also housing for women, orphans, blind children and adults, and as need arose, establishing schools and hospitals. The stated missions of each of the CSJP’s many healthcare ministries (including Holy Name Medical Center (HNMC) in Teaneck, New Jersey, founded in 1925 to “help our community achieve the highest attainable level of health”) attest to the central belief of the CSJP in the sacredness of life and the dignity of each person and to their commitment to improving people’s lives and working collectively for the common good.

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According to Jane F. Ellis, CSJP-A, an Associate of the CSJP and former Vice President of HNMC, addressing the totality of an individual who is ill–caring for the mind, body and spirit–is the defining characteristic of faith-based organizations such as the CSJP. “When someone is ill,” says Ellis, “it is not only the body but also the mind and spirit that are in need of healing. People who are ill are in a state of disequilibrium. By addressing the whole person, they are brought back to equilibrium as well as physical health.” The commitment to caring and compassion, health and wellness, and respect for each individual in mind, body and spirit that is rooted in the ministry of its founders is epitomized in the care offered at HNMC. It is reflected in staff interactions with patients, in the culturally and linguistically sensitive outreach programs developed to serve a diverse community, and in Villa Marie Claire, Holy Name’s residential hospice, which offers a holistic, familycentered approach to achieving quality of life for people with advanced terminal illness. Focusing on the health of the whole person–and the whole community–differentiates faith-based healthcare and elevates the quality of healthcare. Janet S. Puro, MPH, MBA, is Vice President of Business Development and Corporate Communications at MDAdvantage Insurance Company.

In order to obtain AMA PRA Category 1 credit™, participants are required to: 1) Review the CME information along with the learning objectives at the beginning of the CME article. Determine if these objectives match your individual learning needs. If so, read the article carefully. 2) The post-test questions have been designed to provide a useful link between the CME article and your everyday practice. Read each question, choose the correct answer and record your answers on the registration form. 3) Complete the evaluation portion of the Registration and Evaluation Form. Forms and tests cannot be processed if the evaluation section is incomplete. 4) Send the Registration and Evaluation Form to: MDAdvisor CME Dept c/o MDAdvantage Insurance Company 100 Franklin Corner Rd Lawrenceville, NJ 08648 Or Fax to: 978-367-8545 5) Retain a copy of your test answers. Your answer sheet will be graded, and if a passing score of 70% or more is achieved, a CME certificate awarding AMA PRA Category 1 Credit™ and the test answer key will be mailed to you within 4 weeks. Individuals who fail to attain a passing score will be notified and offered the opportunity to reread the article and take the test again.

CAREER JEOPARDY FOR IMPROPER PRESCRIBING OF CONTROLLED SUBSTANCES By Daniel G. Giaquinto, Esq.

6) Mail the Registration and Evaluation Form on or before the deadline, which is May 1, 2017. Forms received after that date will not be processed. Author: Daniel G. Giaquinto, Esq., Kern Augustine Conroy & Schoppmann, P.C. Joint Providership Accreditation: This activity has been planned and implemented in accordance with the Accreditation Requirements and Policies of the Medical Society of The State of New York (MSSNY) through the joint providership of KACS and MDAdvantage Insurance Company. KACS is accredited by The Medical Society of the State of New York (MSSNY) to provide continuing medical education for physicians. Kern Augustine Conroy & Schoppmann, P.C. designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Disclosure: KACS relies upon planners, moderators, reviewers, authors and faculty participants in its CME activities to provide educational information that is objective and free of bias. In this spirit and in accordance with MSSNY and ACCME guidelines, all planners, moderators, reviewers, authors and faculty participants must disclose relevant financial relationships with commercial interests whose products, devices or services may be discussed in the CME content or may be perceived as a real or apparent conflict of interest. Any discussion of investigational or unlabeled use of a product will be identified. The planners, moderators, reviewers, authors and faculty participants do not have any financial arrangements or affiliations with any commercial entities whose products, research or services may be discussed in these materials.

LEARNING OBJECTIVES At the conclusion of this activity, participants will be able to: 1–Describe the legal definition/standard used to determine deviations from the requirements of proper prescribing and medical necessity. 2–State the factors that prosecutors look to when determining if physicians should be charged criminally for prescribing controlled substances. 3–Know the adverse administrative actions that may be taken against a DEA registration or a NJ medical license for unlawful prescribing. 4–Describe practical tips for learning prescribing requirements and instances of improper physician prescribing. It is now recognized that prescription drugs are the most frequently abused drugs in our country. In fact, the United States is currently experiencing an epidemic of dependency on and addiction to prescription drugs. This epidemic is fueled by “diversion,” which is when otherwise lawful prescription drugs are diverted to persons for whom the drugs were not intended or when a patient acquires and

No commercial funding has been accepted for the activity.

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uses medications beyond the medical necessity for which they were prescribed. In response to this growing epidemic, federal authorities, primarily the Drug Enforcement Administration (DEA), as well as state licensing boards, are scrutinizing healthcare practitioners licensed to prescribe, particularly physicians, as enablers of diversion. A physician’s prescription pad is considered the launch pad for diversion, and physicians are being held accountable by federal and state authorities as the gatekeepers to prescription drug dependency and addiction. The DEA derives its authority for monitoring and regulating pharmaceutical controlled substances from the federal Controlled Substances 1 Act (CSA) and its corresponding and implementing regulations.2 Those laws mandate that the DEA prevent, detect and investigate the diversion of legally manufactured controlled substances, while at the same time ensuring that there are adequate supplies to meet the legitimate medical needs for such substances in the United States. The controlled substances are divided into five schedules, which are based on whether the controlled substance has a currently accepted medical use in treatment in the United States and on its potential for abuse.3 There is now growing recognition within the healthcare community that this scrutiny is taking place–and increasing–at the administrative (licensing board) level. What is not yet common knowledge is the growing trend of criminal prosecutions of physicians, at the federal and state levels, for significant deviations from the requirements of proper prescribing and medical necessity.

STANDARDS TO DETERMINE UNLAWFUL PRESCRIBING Federal laws prohibit the unlawful distribution of “controlled substances.”4 New Jersey, similar to all other states, also prohibits unlawful distribution of “controlled dangerous substances” (CDS) in the New Jersey Comprehensive Drug Reform Act of 1987.5 In order to be able to perform their roles and not run afoul of the laws prohibiting distribution of controlled substances, physicians are covered by what I refer to as

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“practitioner immunity.” This so-called immunity allows them to prescribe (and also dispense and administer) controlled substances when legitimately performing their roles as physicians. This longstanding and logical protection is set forth in the implementing regulations to the CSA, which provides that a prescription for a controlled substance is not effective unless it is “issued for a legitimate medical purpose by an individual practitioner in the usual 6 course of his professional practice.” Federal regulations also provide that physicians shall be subject “to the penalties provided for violations of the provisions of law related to controlled substances” when a prescription is not issued: 1) for a legitimate medical purpose 2) by an individual practitioner 3) acting in the usual course of his professional practice.6 New Jersey law mirrors the federal requirement, stating that “(a) prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”7 Further following federal law, New Jersey regulations state that “(a)n order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of Law relating to controlled substances.”7 The U.S. Supreme Court has reinforced these principles in Gonzales v. Oregon, stating that “the prescription requirement … ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, it also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”8 Accordingly, physicians can be held criminally liable at the federal and state levels by knowingly and intentionally prescribing a controlled substance that is not for a “legitimate medical purpose” or not “in the usual course of professional practice.” The terms “legitimate

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medical purpose” and “in the usual course of professional practice” are not well defined in federal or state law. The DEA and other federal and state authorities look to case law, state licensing board regulations, expert opinions and the conventional practices of the medical community to make these determinations. These terms are linked to the concepts of medical necessity, scope of practice and legitimate physician–patient relationships.

FACTORS DETERMINING WHETHER PROSECUTION IS WARRANTED The fundamental factor in making a determination of whether prosecution is warranted is whether the physician established and maintained a bona fide physician–patient relationship. In this vein, in United States v. Moore,9 the U.S. Supreme Court found that a physician exceeded the bounds of professional practice and pointed to a number of relevant factors in reaching that determination. In Moore, the Court outlined the following factors: 1–The physician gave inadequate physical examinations or none at all. 2–The physician ignored the results of the tests that he did make. 3–The physician did not give methadone at the clinic and took no precautions against its misuse and diversion. 4–The physician did not regulate the dosage at all, prescribing as much and as frequently as the patient demanded. 5–The physician did not charge for medical services rendered, but graduated his fee according to the number of tablets desired. In essence, in Moore the Court found that the defendant acted more like a large-scale drug pusher than a physician. An analytical framework arising out of United States v. Rosen10 is often used to determine whether a practitioner has forfeited practitioner immunity. In that case, the Court found the following facts relevant: 1–The physician issued prescriptions to a patient known to be delivering drugs to others. 2–The physician used street slang instead of medical terminology for the drugs prescribed.

3–There was no logical relationship between the drugs prescribed and treatment of the condition that allegedly existed. 4–The physician wrote multiple prescriptions on occasion in order to spread them out. 5–No real physician–patient relationship existed, with very little interaction. 6–An appointment was not necessary for the patient to see the physician. The Moore and Rosen factors are not exhaustive. There are a plethora of factors that can be considered in determining whether a prescription was issued for a legitimate medical purpose and in the usual course of professional practice. Other factors that I have seen play a role in the prosecutorial analysis in federal and state cases in New Jersey and New York include the following: 1–Whether the physician makes appropriate use of the Prescription Monitoring Program (PMP). 2–Whether a physician routinely treats chronic pain without adequate training and/or certification in pain management. 3–Whether a physician is attentive to signs of drug diversion such as negative urine screens, bogus patient excuses for early refills or evidence of a patient using forged or stolen script. 4–Whether the physician appropriately reacts to the tell-tale signs of diversion by refusing a request for an early refill, referring a patient to rehabilitation or discharging a non-compliant patient from the physician’s care. 5–Whether there is objective evidence, such as an MRI, to corroborate the patient’s complaint of chronic pain. 6–Whether there is a pain management contract between the physician and the chronic pain patient. 7–Whether the physician prescribes a controlled substance for a patient’s spouse or significant other without having seen the person for whom the prescription was prescribed. 8–Whether there exists a pattern and practice of violating DEA and/or state licensing board regulations regarding the prescribing, dispensing and administering of controlled substances. 9–Whether patients travel an inordinate distance to the physician.

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10–Whether the physician has had patients who overdosed on opioids, particularly where there is a death that likely resulted from prescriptions written by the physician. 11–Whether the physician’s office and practice have features and appearance consistent with a “pill mill.” 12–Whether the patient visit has the indicia of a legitimate “doctor visit” or was a perfunctory, sham visit. 13–Whether the physician maintains quality records, especially whether there is clear documentation of medical necessity, counseling of patients regarding the proper use of the medication and reasons for any adjustment of the prescription by the physician. 14–In cases involving undercover investigators posing as patients: Whether the patient records accurately reflect what the patient said regarding complaint of pain, symptoms and injury. The decision to prosecute criminally hinges on the analysis of the pertinent facts of each individual case and the degree of proof the prosecutor has obtained. There is no magic formula by which to determine whether criminal prosecution, with the “proof beyond a reasonable doubt” standard, is warranted. Simply put: The more factors on the wrong side of the ledger, the more likely a criminal prosecution. Conversely, the more bona fide the physician–patient relationship, the more medical necessity is truly and accurately demonstrated in the patient medical records and the more compliance with DEA and state licensing board prescribing requirements, the less likely a criminal charge will even be considered.

PENALTIES FOR CONVICTION The penalties for federal and state convictions are severe, with likely–and in some cases, mandatory–terms of imprisonment and hefty monetary penalties, which include fines, restitution, forfeiture and other assessments. The convictions also trigger administrative ramifications, such as license revocation or suspension, Medicare and Medicaid exclusions and credentialing nightmares that many times result in career termination. Under federal law, the penalty varies depending in large part on the nature and aggregate quantity of the controlled substances involved and the court’s analysis of

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the total offense level and criminal history calculations 11 under the U.S. Sentencing Guidelines (USSG), as well as the court’s analysis of the required “3553” statutory factors.12 If charged under New Jersey law, physicians face similarly severe penalties as well.13

ADVERSE ACTIONS FROM THE DRUG ENFORCEMENT ADMINISTRATION Regardless of whether an investigation results in criminal charges, one can still expect administrative action from the DEA to revoke a practitioner’s DEA registration and disciplinary action from the New Jersey State Board of Medical Examiners (the Board) for prescribing that is indiscriminate or otherwise violates applicable rules and regulations. Adverse administrative actions can be just as crippling to a medical career as criminal charges. It is important to note that the standard of proof, “preponderance of the evidence,” is a lower standard than that which is required in a criminal prosecution. In conjunction with this lower standard of proof, the same prosecutorial factors discussed above are also analyzed in determining whether adverse administrative action is warranted. Starting at the lower level of the DEA administrative spectrum, a private Letter of Admonition may be issued to the provider, which acts as a warning and is a record of admonishment that will be taken into account by DEA should there be future violations. For a case that warrants a greater administrative sanction, the DEA may issue an “order to show cause” why the physician’s registration should not be revoked or suspended. If this avenue is pursued, the matter will be heard by a U.S. Administrative Law Judge (ALJ). The standard that is applied is whether the physician’s continued registration “is inconsistent with the public interest.”14 The provider will be given due process and a hearing. The ALJ will issue a non-binding “Recommended Opinion” that will be forwarded to the DEA Administrator, who may adopt, modify or reject the ALJ opinion in finally deciding the fate of the physician’s DEA registration. Sometimes, a middle ground, a Memorandum of Agreement (MOA), in lieu of an order to show cause, may be pursued in negotiations. This is a voluntary agreement that for a specified time period the physician agrees to take certain measures to address whatever deficiencies were found.

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A particularly worrisome action that has occurred with increasing frequency is the DEA practice of requesting (or demanding–depending on one’s perspective) the surrender of a physician’s DEA registration during an unscheduled office visit, based on allegations of violations of the CSA or its regulations. Sometimes, this is done in conjunction with investigators from the New Jersey Division of Consumer Affairs who seek a surrender of the State CDS registration at the same time. The DEA agents do so by asking the physician to sign a DEA Form 104–a surrender form entitled Voluntary Surrender of Controlled Substances Privileges. A voluntary surrender of a DEA registration is effective immediately upon a DEA employee’s receipt of a signed surrender form or surrender in any written 15 format. Such a surrender should never be signed without the advice of legal counsel.

ADVERSE ACTIONS FROM THE NEW JERSEY STATE BOARD OF MEDICAL EXAMINERS The New Jersey State Board of Medical Examiners has broad investigative powers, including the authority to compel records and testimony.16 Prescribing or dispensing “controlled dangerous substances indiscriminately or without good cause, or where the applicant or holder knew or should have known that the substances were to be used for unauthorized consumption or distribution” is grounds for discipline by the Board.17 Failure to comply with New Jersey prescribing regulations,18 which is grounds for discipline since it is a failure to comply with the provisions of an Act or regulation administered by the Board,19 may also be additional grounds for discipline if found to constitute gross negligence, gross malpractice or gross incompetence that damaged or endangered the life, health, welfare, safety or property of any person; repeated acts of negligence, malpractice or incompetence; professional or occupational misconduct; or an

act or acts constituting any crime or offense of moral turpitude or relating adversely to any activity regulated 20 by the Board. In cases where violations are sustained, the Board may impose discipline in the form of suspension or revocation of the medical license, as well as additional penalties such as civil fines and penalties, skills assessment, assignment of a monitor, mandated medical or diagnostic testing and psychological evaluation and any corrective action deemed 21 necessary by the Board. In matters where a clear and imminent danger to the public health, safety and welfare is palpably demonstrated, the Board may issue a temporary order suspending or limiting a license pending a plenary hearing.22

CONCLUSION The medical community is forewarned that prescribing controlled substances, particularly by those who are outliers in their prescribing of controlled substances, is a current area of heightened scrutiny with the DEA, other authorities with criminal investigative authority and the Board. In order to avoid criminal prosecution, physicians must establish and maintain a bona fide physician–patient relationship with all patients for whom controlled substances are prescribed. Physicians must issue prescriptions for controlled substances “for a legitimate medical purpose in the usual course of professional practice.” To remain within this definition, physicians should be aware of the prosecutorial analysis factors set forth above, as well as the DEA requirements for prescribing.23 In addition, remember that adverse administrative action can be taken in conjunction with criminal prosecution and can be taken even when there is not enough proof for a criminal prosecution. The same factual analysis would apply, and the proof required in an administrative action is lower than that required in a criminal action. A practitioner’s manual has been prepared by the DEA

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to assist practitioners (physicians, dentists, veterinarians and other registrants authorized to prescribe, dispense and administer controlled substances) in their understanding of the CSA and its corresponding regulations. The manual is an informational outline and practical guide that can assist in obtaining quick answers to pre24 scribing questions. The manual can be found online at www.deadiversion.usdoj.gov/pubs/manuals/index.html. Another useful guide to help practitioners better understand the laws regarding diversion in the prescribing of controlled substances is a report entitled Cases Against Doctors. This report presents criminal and administrative actions against physicians, which are opinions involving DEA administrative sanctions against registrants at the DEA Office of Diversion Control’s website. These opinions are a great source for learning where other practitioners around the country went wrong.25 The report can be found at www.deadiversion.usdoj.gov/crim_admin_actions/doctors_c riminal_cases.pdf. Of equal importance in avoiding criminal and administrative charges is knowledge of New Jersey’s prescribing requirements.26 Keep in mind New Jersey’s examination of patient requirements and exceptions, requirements regarding written prescriptions and the special requirements for management of pain.27 Although DEA and New Jersey requirements regarding prescribing controlled substances are very similar and sometimes mirror each other, where there is a difference, the more restrictive rule should be followed. When in doubt, seek legal or appropriate expert guidance. In addition to compliance with statutory and regulatory requirements, sound physician decision-making, based on medical necessity and the best interests of the patient, and proper documentation in patient records are crucial in avoiding criminal and administrative liability. Daniel G. Giaquinto is a partner in the law firm of Kern Augustine Conroy & Schoppmann, P.C.

21 C.F.R. 1306.04(a).

N.J.A.C. 13:45H–7.4.

Gonzales v. Oregon, 546 U.S. 243 (2006).

423 U.S. 122 (1975).

United States v. Rosen, 582 F.2d 1032 (5th Cir. 1978).

U.S. Sentencing Commission. (2015). Guidelines manual. www.ussc.gov/guidelines-manual/2015/2015-ussc-guidelines-manual. Note: For specific information see: Specific offense characteristics, Chapter 2, Part D; the relevant upward or downward adjustments, Chapter 3; Criminal History and Criminal Livelihood, Chapter 4; relevant specific offender characteristics, Chapter 5, Part H; and relevant grounds for departure, Chapter 5, Part K.

18 U.S.C. §3553(a).

N.J.S.A. 2C:35–5; 2C: 43–3; 2C:43–6; 2C: 44–2.

21 U.S.C. § (a) (4).

21 C.F.R. § 1301.52(a).

N.J.S.A.45:1–18; 45:1–18.2; 45:1–20.

N.J.S.A. 45:1–21(e).

N.J.A.C. 35:7.1–7.9.

N.J.S.A. 45:1–21(h).

N.J.S.A. 45:1–21(c)(d)(e)(f).

N.J.S.A. 45:1–21; 45:1–22.

N.J.S.A. 45:1–22.

21 U.S.C. § 829; 21 C.F.R. § Part 1306.

U.S. Department of Justice, Office of Diversion Control. (n.d.). Manuals. www.deadiversion.usdoj.gov/pubs/manuals/index.html.

U.S. Department of Justice, Office of Diversion Control. (2015, December 10 [updated]). Cases against doctors. www.deadiversion.usdoj.gov/crim_admin_actions/doctors_c riminal_cases.pdf.

21 U.S.C. § 801–971.

21 C.F.R. § part 1300–321.

21 C.F.R. § 1308.11–1308.15.

N.J.A.C. 35: 7.1–7.10.

21 U.S.C. § 841.

N.J.A.C. 35: 7.6; N.J.A.C. 35: 7.2; N.J.A.C. 35: 7.1A.

N.J.S.A. 2C:35–1 et seq.

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CAREER JEOPARDY FOR IMPROPER PRESCRIBING OF CONTROLLED SUBSTANCES CME EXAMINATION (Deadline May 1, 2017)

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1) When there is a difference between a DEA and NJ rule on prescribing: a) Follow the more restrictive rule b) Follow the NJ rule c) Follow the DEA rule d) None of the above 2) Adverse administrative action against a physician’s DEA registration or State license cannot occur if a criminal prosecution has occurred or is taking place because of the principle of double jeopardy. a) True b) False 3) Having a bona fide physician–patient relationship is a crucial factor in avoiding criminal charges for physicians who prescribe controlled substances. a) True b) False 4) The federal Controlled Substances Act (CSA) and its corresponding regulations are the only source of regulation for prescribing controlled substances. a) True b) False 5) The determination of whether prescribing was for a legitimate purpose in the usual course of medical practice can be guided by: a) Compliance or non-compliance with state licensing board regulations b) Case law c) Expert opinions d) All of the above e) a and c only

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6) Although criminal prosecution can put a physician’s freedom at stake, adverse administrative actions can also terminate or severely set back a medical career. a) True b) False 7) The surrender of a DEA registration occurs upon the handing over of a signed DEA Form 104 or other written surrender form to a DEA employee. a) True b) False 8) In order to avoid unlawful prescribing, a physician should do the following: a) Counsel patients regarding the dangers and appropriate uses of controlled substances b) Make appropriate use of the Prescription Monitoring Program c) Regardless of objective findings, be sympathetic to and compliant with patient requests for prescriptions d) Ignore signs of diversion in order to maintain good patient relations e) a and b only f) None of the above 9) Physicians cannot be prosecuted for unlawful drug distribution since the act of prescribing is not a distribution. a) True b) False 10) Although the standard of proof in an adverse administrative action is only “preponderance of the evidence,” the same individual case factors can be analyzed to determine whether unlawful prescribing has occurred. a) True b) False

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CAREER JEOPARDY FOR IMPROPER PRESCRIBING OF CONTROLLED SUBSTANCES REGISTRATION AND EVALUATION FORM

(Must be completed in order for your CME Quiz to be scored – Deadline for Response: May 1, 2017) REGISTRATION FORM First Name

Middle Initial

Last Name

City

State

ZIP

Phone

E-mail Address

Specialty

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Address

ANSWER SHEET Circle the correct answer. 1) A B C D

2) T F

3) T F

4) T F

5) A B C D E

6) T F

7) T F

8) A B C D E F

9) T F

10) T F

Number of hours spent on this activity _______ (reading article and completing quiz) I attest that I have read the article “Career Jeopardy for Improper Prescribing of Controlled Substances” and am claiming 1 AMA PRA Category 1 Credit.™ Signature EVALUATION 1. 2. 3. 4.

The The The The

Date Completed by

content of the article was: author’s writing style was: graphics included in the article were: stated objectives of this program were:

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Non-Physician

Excellent___ Good___ Fair___ Poor___ Excellent___ Good___ Fair___ Poor___ Excellent___ Good___ Fair___ Poor___ Exceeded____ Met____ Not met_____

Was this article free of commercial bias? Yes _________ No _________ If not, why not __________________________________________________________________________ Please share your name and contact information so that we may investigate further. Participant Name __________________________________ Telephone/E-mail: _____________________ 5. Will the knowledge learned today affect your practice? Very Much____ Moderately____ Minimally____ None____

7. Did this CME activity change what you know about: • The legal definition/standard used to determine deviations from the requirements of proper prescribing and medical necessity. Yes ❑ No ❑ • The factors that prosecutors look to when determining if physicians should be charged criminally for prescribing controlled substances. Yes ❑ No ❑ • The adverse administrative actions that may be taken against a DEA registration or a NJ medical license for unlawful prescribing. Yes ❑ No ❑ • The practical tips for learning prescribing requirements and instances of improper physician prescribing. Yes ❑ No ❑ 8. Based on your participation today, what barriers to the implementation of the strategies or skills taught today have you identified? Suggested topics for future programs:_________________________________________________________________________________

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6. Based on your participation in the CME activity, will you change the way you practice medicine? __Yes Describe ___________________________________________________________________________________ __No Why not ___________________________________________________________________________________ __N/A Were you the wrong audience for this activity? _________________________________________________

sharing intelligence in an

interconnected world

By Acting Commissioner Cathleen D. Bennett & Chris Rodriguez, PhD Like the business and financial sectors, the healthcare sector is increasingly being hit with digital thefts and data breaches. In one four-week period, Beckerâ&#x20AC;&#x2122;s Hospital Review recorded 18 cyberattacks among hospital systems across the United States.1 Hospitals and other healthcare settings are especially vulnerable targets because of their electronic medical records, which contain Social Security numbers and private health information. Cybercrimes in healthcare settings have huge consequences economically and in terms of violations of patient privacy. As technologies become more complex and new threats emerge in the health sector, it is increasingly important for healthcare systems to identify their vulnerabilities and invest in different layers of security to protect their patients and their data systems. The New Jersey Department of Health and the

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Dr. Chris Rodriguez, Director of the New Jersey Office of Homeland Security and Preparedness, highlights how the healthcare system can protect against cyber threats.

Acting Health Commissioner Cathleen Bennett emphasizes the importance of keeping healthcare data secure.

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New Jersey Office of Homeland Security are working together to strengthen healthcare cybersecurity preparedness through strategic partnerships among the State, national intelligence experts and the hospital industry. The New Jersey Cybersecurity and Communications Integration Cell (NJCCIC) and the National Healthcare Information Sharing and Analysis Center (NH-ISAC) have partnered to enhance cybersecurity information sharing on behalf of New Jersey’s healthcare providers. As the State’s one-stop shop for cybersecurity information sharing, threat analysis and incident reporting, the NJCCIC serves governments, businesses and citizens across New Jersey by promoting greater awareness of cyberthreats and widespread adoption of best practices. The agreement for New Jersey healthcare facilities to participate in NJCCIC was formally executed during a press conference we attended with hospital executives from across the State on January 26, 2016, at the New Jersey Regional Operations Intelligence Center. Under the agreement, intelligence will be shared and analyzed on behalf of New Jersey’s healthcare and public health

institutions to strengthen their ability to prepare for and respond to threats. The partnership mandates strict data handling along with classification and disclosure protocols to protect confidentiality. The NJCCIC fuses technical and nontechnical resources to analyze New Jersey’s local cyberthreat landscape and reduce the State’s virtual vulnerabilities. In addition to cybertips, alerts and mitigation techniques, the NJCCIC produces sector-specific threat assessments. The analysis correlates to historical and current data and reflects our collaborative relationship with local, state, federal and industry partners. The NJCCIC and the NH-ISAC will perform automated information sharing to exchange cyberintelligence data from their respective organizations in real time. Information sharing is most effective when intelligence awareness outpaces the proliferation of threats. This partnership helps New Jersey and our healthcare providers keep pace with new attack methodologies as they emerge in the healthcare sector’s ever-changing technology landscape. “The automated sharing of indicators is another step in the evolution of information sharing and situational awareness,” said Denise Anderson, President of the NH-ISAC and Chair of the National Council of ISACs. “We are very pleased to be entering into this formal partnership with NJCCIC to share cyberthreat information, and we look forward to working with NJCCIC to help critical infrastructure owners and operators protect the resilience and integrity of their operations.” The State values the information exchange it has established with hospitals throughout New Jersey. This strong communication leverages technology, as well as establishes professional relationships. Communication is a two-way street, as data are shared with the State’s healthcare and public health continuum on an ongoing basis. This collaboration intensifies during emergencies to ensure resource needs are met. Hippocrates, the Department of Health’s web-based communications system, provides a common platform for hospitals and other members of the continuum to share critical information vital to the ability to effectively respond to cybercrimes and other emergency incidents. Some of the information shared includes whether a hospital is accepting patients, how many beds are available and if it is experiencing power outages. Real-time information reporting allows

users to prepare for and respond to natural or manufactured health threats in real time. Continuous communication also helps users recover after incidents conclude. As the State shares data with our hospitals continuously, the Department recognizes its role in protecting that information. For example, as the Department of Health builds the NJ Health Information Network (NJHIN)–which allows regional health information organizations to share data across the state–data safeguards will be put in place to monitor and protect communications. The NJHIN will provide the technology platform that enables electronic exchange of patient health information among health organizations and State health data sources. We will build our capacity to keep information secure, identify threats, assess vulnerabilities and respond to incidents. Raising awareness of risks to the healthcare system is essential to strengthening a hospital’s cybersecurity preparedness efforts, whether cyberthreats are homegrown or worldwide. Hospitals have a lot of experience exchanging data to improve quality of care and sharing resources through regional health information organizations. The healthcare system is doing a great job now, but as digital communications evolve and technology shifts, we all need to adapt. New Jersey’s healthcare sector is critical to the livelihood of its citizens and the prosperity of our local economy. Partnering to share cyberintelligence information will contribute to a far greater understanding of the threats impacting our healthcare providers. Enhanced information provided through the NJCCIC–NH-ISAC partnership will give hospitals information that can be used to bolster their cyber-response capabilities and better integrate State and federal intelligence. A partnership like this is one of the best ways the State can work with hospitals to keep New Jersey residents healthy while keeping their medical records secure from cyberpredators. Because threats often come without warning, it is never too early to enhance preparedness. Cathleen D. Bennett is the Acting Commissioner of the New Jersey Department of Health. Chris Rodriguez, PhD, is the Director of the New Jersey Office of Homeland Security. 1

Jayanthi, A. (2016, March 11). 18 latest data breaches. Becker’s Health IT & CIO Review. www.beckershospitalreview.com/ healthcare-information-technology/18-latest-data-breaches3-11-16.html.

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The Significance of

Decrease in Coronary the

Heart Disease

Rates*

By William G. Rothstein, PhD

Coronary heart disease** rose from being a minor cause of death early in the 20th century to being the leading cause of death in most advanced countries around the middle of the century. More money has been spent in the United States on prevention and treatment of this disease than on any other disease. It was assumed that the increase in coronary heart disease was the direct result of long-term changes in American lifestyles, and that it had become an endemic disease whose high rates would continue indefinitely. As a result, the American public has been overwhelmed with recommendations to modify lifestyles and risk factors to prevent the disease.1 Widespread adoption of the recommendations has been considered essential in reducing rates of the disease. Coronary heart disease mortality rates decreased substantially in all affected countries, beginning in about 1970 or 1980 (depending on the country). However, the rapid and substantial simultaneous increases and decreases of rates of coronary heart disease in so many advanced countries indicate that it is more accurately considered a

pandemic than an endemic disease. The failure to recognize the pandemic nature of the disease is not surprising because pandemics of chronic diseases are difficult to identify. An increase in the number of cases can result from more elderly persons in the population, greater awareness of the disease or improved methods of diagnosis. The most notable and tragic failure to recognize a recent chronic disease pandemic was the long delay in recognizing the pandemic of lung cancer caused by cigarette smoking. This paper will document the increases and decreases in coronary heart disease mortality rates and demonstrate that certain population groups and geographic areas were most affected by the disease, as occur in pandemics generally. It will examine some accepted lifestyle risk factors and describe their changes during the emergence and decline of the pandemic. This paper will also recommend that prevention programs in the post-pandemic era be modified from a total population approach to a high-risk group approach, which enables the healthcare community to focus its efforts and reduce healthcare expenditures.

â&#x2C6;&#x2014; This paper consists of material from a larger study intended for publication as a book. The author would like to thank James Mohr, W. Bruce Fye and the late Gerald Grob for their helpful comments and suggestions. â&#x2C6;&#x2014;â&#x2C6;&#x2014; The term coronary heart disease will be used for expediency regardless of changes in terminology.

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THE EMERGENCE AND DECLINE OF THE CORONARY HEART DISEASE PANDEMIC Coronary heart disease in the early 20th century was a minor cause of death in the United States, responsible for less than 1 percent of deaths for each sex in every age group. Mortality rates in other advanced countries were also extremely low. Careful analyses have demonstrated that these low rates were not due to the diagnostic 2 limitations of contemporary physicians. Mortality rates began to increase in the 1930s in most advanced countries. Men in every age group experienced greater increases in rates than women of the same ages in every country, which suggests that similar causal factors operated everywhere. All adult age groups experienced increases, which indicates that population aging was not the responsible factor. Coronary heart disease mortality rates for the U.S. population aged 55 to 64 demonstrate the historical contours of the pandemic in a severely affected country. In 1940, coronary heart disease mortality rates per 1,000 for that age group were 3.8 for white men, 1.8 for black men,

1.2 for white women and 1.2 for black women. In 1970, the rates increased to 9.0 for white men, 9.6 for black men, 2.7 for white women and 5.9 for black women. In 2010, the rates decreased to 1.9 for white men, 2.6 for black men, 0.6 for 3 white women and 1.2 for black women. The patterns were similar for all other adult age groups. In England and Wales, as in all of Western Europe, the coronary heart disease pandemic was less severe. In England and Wales, only men experienced increases in mortality rates, but both sexes experienced decreases during the decline. Again using persons ages 55 to 64, in 1941 coronary heart disease mortality rates per 1,000 were 4.5 for men and 2.3 for women. In 1971, the rates increased to 6.9 for men and decreased to 1.8 for women. In 2001, the mortality rates decreased to 2.7 for men and 0.8 for women, practically identical to the rates of 2.8 for white men and 1.0 for white women in the United 4 States in 2000. Considering other advanced countries, mortality rates similar to those in the United States occurred in Canada, Australia and New Zealand. The countries of Western Europe experienced lower mortality rates, but the rates varied

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considerably among the countries. The highest peak mortality rates occurred in every country above the 50th parallel: Ireland, the United Kingdom, Belgium, the Netherlands, Denmark, Norway, Sweden and Finland. The lowest peak mortality rates occurred in every country below the 50th 5 parallel: France, Switzerland, Italy, Portugal and Spain. As the pandemic declined, the greatest decreases in mortality rates occurred in countries with the highest rates during its peak. For example, from 1980 to 2000 in Western Europe every country above the 50th parallel experienced greater decreases in mortality rates for men and women than every country below it.5 The striking variations in the mortality rates of age, sex, race groups and geographic areas during the coronary heart disease pandemic are typical of pandemics. These types of variations occurred in the recent AIDS pandemic, the influenza pandemic of 1917â&#x20AC;&#x201C;1919 and the tuberculosis pandemic of the 19th century. CORONARY HEART DISEASE RISK FACTORS AND THE PANDEMIC Decreases in mortality rates from any disease result from some combination of fewer new cases of the disease and improved treatment of persons with the disease. Multinational research has shown that most of the decrease in deaths from coronary heart disease was due to fewer new cases, not to improved treatment.6 Fewer new cases did not result from two widely used pharmaceuticals prescribed to treat risk factors. In the United States, the use of statin drugs to reduce blood cholesterol levels became popular 30 years after mortality rates began to decrease. Many studies have found that drug treatment of high blood pressure has never achieved widespread success. The decline of the coronary heart disease pandemic modified important individual risk factors for the disease. During the peak of the pandemic, men had much higher mortality rates than women, and older persons had much higher mortality rates than younger persons. As the pandemic declined, the differences in mortality rates between these groups narrowed substantially. For example, in the United States between 1970 and 2010 for those aged 55 to 64, coronary heart disease mortality rates per 1,000 for white men decreased from 9.0 to 1.8 and those for white women decreased from 2.7 to 0.6. The differences between the

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sexes thus narrowed from 6.3 deaths to 1.2 deaths per 1,000 persons. Considering older and younger age groups, white men ages 65 to 74 had 17.0 more deaths per 1,000 persons than those ages 45 to 54 in 1970 but only 3.1 more deaths in 2010. White women ages 65 to 74 had 8.8 more deaths per 1,000 persons than those ages 45 to 54 in 1970 but only 1.5 more deaths in 2010. Similar patterns and trends occurred for the black population and 7 other age groups. Obesity is another risk factor that decreased in importance as the pandemic declined. Many large-scale studies in the United States at the peak of the pandemic demonstrated that obesity was an important risk factor for coronary heart disease.8 During the decline of the pandemic in the late 20th century, however, population obesity rates increased substantially while population coronary heart disease rates decreased. The geographic scope of the pandemic renders it highly improbable that changes in the consumption of dietary cholesterol and saturated fats could have produced either the increase or the decrease in coronary heart disease rates.9 The pandemic occurred almost simultaneously in about 16 countries that had consumed different diets for centuries. It is inconceivable that all of these countries experienced identical changes in diet before the emergence of the pandemic and different identical changes in diet before the beginning of the decline of the pandemic. The so-called Mediterranean diet, which is claimed to reduce the risk of coronary heart disease, was developed based on the lower mortality rates of Italy and Spain. However, France and Switzerland have had the same mortality rates as Italy, and neither of those countries is considered to have a Mediterranean diet. CORONARY HEART DISEASE IN THE 21ST CENTURY Coronary heart disease in the 21st century has become primarily a disease of the very old. Between 1970 and 2010 in the United States, the percentages of all coronary heart disease deaths that occurred at ages 75 or older increased from 39 percent to 56 percent for white men, from 64 percent to 79 percent for white women, from 26 percent to 36 percent for black men and from 35 percent to 60 percent for black women. An extreme case is seen in white women, where the percentage of deaths that

occurred at ages 85 and older increased from 25 percent to 7 53 percent over the period. THE NEED TO RE-EVALUATE METHODS OF PREVENTION The much lower current coronary heart disease mortality rates and older ages of persons with the disease indicate the need to reevaluate methods of prevention. Decreases in rates of other major long-term pandemic diseases, such as tuberculosis, have produced changes in prevention programs from a focus on entire populations to a focus on high-risk groups. A shift in focus to high-risk groups for coronary heart disease would reduce healthcare utilization and expenditures. Recommendations about risk factor modifications would be made with greater precision because they would be based on research involving specific population groups. The shift of attention to high-risk groups will require new types of research on methods of prevention for the age and sex groups currently at highest risk. Mortality rates are now low enough that outcome measures must describe actual mortality rates. Changes in risk factors as outcome measures, such as lower blood cholesterol or blood pressure levels, cannot be justified. Statistical techniques must measure changes in absolute risk. Relative risk measures (e.g., percent reduction in mortality rates) provide no information on the number of deaths or cases of disease prevented–information that is essential when rates are low. The coronary heart disease pandemic created a large structure of medical organizations and professionals directly involved in prevention of the disease in the general population. A focus on prevention in high-risk groups has the potential to significantly reduce the number of medical examinations, diagnostic tests and pharmaceuticals given to patients in low-risk groups. A focus on high-risk groups would reduce the number of false positives from diagnostic tests and adverse reactions from pharmaceuticals used to treat risk factors in patients who do not benefit from them. The much lower rates of coronary heart disease offer an excellent opportunity to reduce healthcare expenditures. The United States spends more money per person on healthcare than every other advanced nation and has a less healthy population than every one of them. Healthcare expenditures can be controlled by the medical community or by the political system, but the medical community can reduce health expenditures more compassionately and equitably than the political system. Healthcare professionals have the opportunity and 30

MDADVISOR | SPRING 2016

responsibility to modify their approach to a disease that has changed its nature significantly in the 21st century. William G. Rothstein, PhD, is Professor Emeritus of Sociology at the University of Maryland Baltimore County. 1

Rothstein, W. G. (2003). Public health and the risk factor: A history of an uneven medical revolution. Rochester, NY: University of Rochester Press.

Anderson, T. W., & Le Riche, W. H. (1970). Ischemic heart disease and sudden death, 1901–1961. British Journal of Preventive and Social Medicine, 24, 1–9; Cassidy, M. (1946). Coronary disease: The Harveian oration of 1946. Lancet, 6416, 587–590. Note: For a discussion of the recognition of coronary heart disease in the early years of the pandemic, see Rothstein, W. G., 195–209.

Note: The 1940 data are from Linder, F. L., & Grove, R. D. (1943). Vital statistics rates in the United States, 1900–1940 (pp. 534–553). Washington, DC: U.S. Government Printing Office. Note: The 1970 and 2010 data were obtained by request from CDC Wonder at http://wonder.cdc.gov.

Charlton, J. (1997). Trends in all-cause mortality: 1841-1994. In J. Charlton & M. Murphy (Eds.), The health of adult Britain, 1841-1994 (Vol. 1, p. 23). London: Office of National Statistics; Charlton, J., Murphy, M., Khaw, K., Ebrahim, S., & Smith, G. (1997). Cardiovascular diseases. In J. Charlton & M. Murphy (Eds.), The health of adult Britain, 1841-1994 (Vol. 2, p. 65). London: Office of National Statistics; Office of National Statistics. (2002). Mortality statistics cause: Review of the registrar general on deaths by cause, sex, and age in England and Wales, 2001 (Series DH-2, no. 28). London: Author.

World Health Organization Regional Office for Europe. (2015, December [updated]). European health for all database (HFADB). data.euro.who.int/hfadb. Note: The unification of West and East Germany precluded analyses of their mortality rates.

Tunstall-Pedoe, H., Kuulasmaa, K., Mähönen, M., Tolonen, H., Ruokokoski, E., & Amouyel, P. (1999). Contribution of trends in survival and coronary-event rates to changes in coronary heart disease mortality: 10-year results from 37 WHO MONICA project populations. Lancet, 353, 1547–1557.

Note: The 1970 and 2010 data were obtained by request from CDC Wonder at http://wonder.cdc.gov.

Rothstein, W. G. (2003), 338–341; Fumento, M. (1997). The fat of the land: The obesity epidemic and how overweight Americans can help themselves. New York: Viking.

Note: A history of the diet-heart hypothesis is in Levenstein, H. (2012). Fear of food: A history of why we worry about what we eat (pp. 125–159). Chicago: University of Chicago Press.

NEW

LEG ISLATIV Y E SE U R

TE: DA P

By Michael C. Schweder In February, Governor Christie kicked off the unofficial start of the budget season in Trenton as he delivered his seventh Budget Address to the New Jersey State Legislature. The Governor described his $34.8 billion budget as being “balanced through fiscal responsibility, and not on the backs of our citizens, for the seventh straight year, this budget 1 imposes no new taxes on the people of New Jersey.” The Governor’s budget will be aided by his administration’s projected revenue increase of 3.1 percent in Fiscal Year 2017 (FY17): Gross income tax (GIT) revenue is projected to grow by 4.8 percent in FY17, the sales tax is projected to expand by 3 percent and the corporation business tax (CBT) revenue is expected to remain flat in FY17.2 Pension payments, or the lack thereof, have been a controversial issue in Trenton for the past few years. In FY17, the Governor has allocated a $1.9 billion contri-

GOVERNOR CHRISTIE’S PROPOSED FY17 BUDGET, HORIZON’S OMNIA PLAN & HEALTHCARE LEGISLATIVE BILLS

“A large portion of the proposed $34.8 billion budget has been allocated to the healthcare sector, including $775.1 million in funding to the hospitals in New Jersey.”

MDADVISOR | SPRING 2016

bution to the pension system, which is $555 million more than FY16. 2 Governor Christie explained that this increased contribution assumes that “a combination of reasonable new reforms will save $250 million in public employee and retiree health care costs to offset anticipated growth.”2 The Governor believes that these savings will come from “reasonable reforms such as requiring the use of generic drugs when available, modest increases in co-pays to discourage unnecessary visits, and establish new delivery methods for primary care services.”1 A large portion of the proposed $34.8 billion budget has been allocated to the healthcare sector, including $775.1 million in funding to the hospitals in New Jersey. However, this number is a reduction of $89 million from FY16’s total of $864.4 million.3 A large chunk of the hospital budget is Charity Care, and this has been cut by more than $150 million, but the Governor’s budget still assigns a total of “$352 million for Charity Care in combined Federal and State support to offset the costs hospital facilities incur in treating the uninsured.”2 Other major budget items for the hospitals stayed the same in FY17, such as the Delivery System Reform Incentive Payments

funded at $166.6 million, the Hospital Mental Health Offset Payments at $24.7 million and the University 2 Hospital total equaling $43.8 million. Other healthcare budget items include the following: an increase of $60 million toward the Graduate Medical Education system with total funding of $188 million, $127 million to address mental health and substance addiction, $64 million to maintain and expand the Drug Court Program and $25.8 million to support Children’s System of Care (CSOC), which addresses the holistic needs and concerns of families with children with multiple needs, including behavioral health, substance use and intellectual 2 and developmental disabilities. The budget season will continue when the New Jersey Legislature holds its own hearings to review the Governor’s budget. State law mandates that the Budget must be passed by the State Legislature and signed by the Governor by July 1, 2016. OMNIA: TIERED HEALTH PLAN The new OMNIA tiered health plan offered by Horizon Blue Cross Blue Shield of New Jersey (HBCBSNJ) has met severe opposition from hospitals and the overall healthcare community in New Jersey. The plan divides doctors and hospitals into either Tier 1 or Tier 2 narrow networks; Horizon believes tiered plans will “benefit consumers by charging lower copays and contributions, in exchange for less patient flexibility when it comes to choosing doctors or hospitals. Healthcare providers that agree to participate in these restricted networks, or in the least expensive tier, accept lower rates of reimbursement for their services from the insurance company, but are guaranteed a certain volume of patients.”4 Most Tier 2-designated hospitals filed a lawsuit against HBCBSNJ’s OMNIA plan for lack of transparency of their tiered classifications and for how it will potentially “harm many of the state’s smaller, community, or safety-net hospitals as consumers migrate elsewhere to save money.” 5 Horizon responded to this lawsuit by filing its own legal action to block the public relations campaign against HBCBSNJ by those same Tier 2 providers.6 On March 7, 2016, the New Jersey Senate Commerce Committee held another public hearing on the OMNIA plan, and Senate President Stephen Sweeney (D-Gloucester)

testified in favor of OMNIA. The Senate President explained how the plan can provide out-of-pocket savings for customers, and he stressed that “we are in a new world. The rising cost of healthcare in New Jersey…is killing customers, unions, and businesses.” He then urged opponents of OMNIA to 7 “put the interests of the customers first.” Senator Nia Gill (D-Essex) and Senator Joseph Vitale (D-Middlesex) had requested the Attorney General’s office examine the Department of Banking and Insurance’s (DOBI) decision to approve OMNIA; the Attorney General’s office 8 declared OMNIA did not break any state laws. The State Legislature then “re-introduced eight bills intended to improve the design of similar insurance plans…[and] establish new standards for tiered plans and increase the transparency around the development of these plans.”6 More hearings are scheduled to be held on tiered healthcare plans in the future. LEGISLATIVE BILLS TARGETING HEALTHCARE Senate Bill No. S-1198: This bill was introduced by Senator Kean (R-LD21) and referred to the Senate Judiciary Committee. S-1198 would establish a Medical Malpractice Court similar to a Tax Court and would have jurisdiction for certain situations, such as: “(1) any dispute concerning medical malpractice liability insurance; (2) any action where the parties have agreed in writing that any matter arising out of the agreement would be resolved in Medical Malpractice Court; and (3) any action for injury against a health care provider based on negligence.”9 Senator Kean has introduced S-1198 in previous legislative sessions, but it has yet to gain traction and move closer to becoming law. The major concern for this bill is the cost the state will incur to finance the Medical Malpractice Court, with yearly costs estimated near $9 million.10 RECENTLY INTRODUCED TIERED HEALTH LEGISLATION The following bills have been introduced in the New Jersey General Assembly and State Senate pertaining to tiered health plans. Assembly Bill No. A-886: “Establishes certain network adequacy and standard application requirements for health insurance carriers; requires determination of hospital diversity for tiered networks.”11 Assembly Bill No. A-887: “Requires carriers to disclose

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selection standards for placement of health care providers in tiered health benefits plan network; establishes oversight monitor to 12 review compliance.” Assembly Bill No. A-888: “Establishes ‘New Jersey Task Force on Tiered Health Insurance 13 Networks.’” Assembly Bill No. A-2327: “Places moratorium on implementation of certain tiered network health benefits plans until January 1, 2017.”14 Assembly Bill No. A-2328: “Requires health insurance carriers to comply with certain network adequacy requirements.”15 Assembly Bill No. A-2329: “Establishes certain standards for health benefits plans and tiered network.”16 Assembly Bill No. A-2528: “Requires health insurance carriers offering tiered network health benefits plans to protect covered persons from excess cost sharing in certain circumstances.”17 Michael C. Schweder is the Director of Government Affairs at CLB Partners, LLC, in Trenton, New Jersey.

16/02/25/opposition-to-omnia-continues-to-grow-as-nursesjoin-protest-line. 6

Stainton, L. H. (2016, February 4). Insurance giant defends controversial OMNIA plan in response to ‘smear’ campaign. NJSpotlight. www.njspotlight.com/stories/16/02/03/insurancegiant-defends-controversial-omnia-coverage.

Stainton, L. H. (2016, March 8). Senate President Sweeney weighs in on OMNIA debate, favors tiered network. NJSpotlight. www.njspotlight.com/stories/16/03/07/senatepresident-sweeney-weighs-in-on-omnia-debate-favorstiered-network.

Livio, S. K. (2016, March 5). Horizon’s controversial insurance plan breaks no laws, attorney general says. NJ.com. www.nj.com/politics/index.ssf/2016/03/attorney_general_ horizons_new_insurance_plans_brea.html#incart_river_index.

Kean, T. H. (2015, February 8). Senate No. 1198; State of New Jersey 217th Legislature. www.njleg.state.nj.us/2016/ Bills/S1500/1198_I1.HTM.

State of New Jersey. (2010, May 14). Senate No. 524; State of New Jersey 214th Legislature. www.njleg.state.nj.us/2010/ Bills/S1000/524_F1.HTM.

Muoio, E. M. (Pre-2016 Session). Assembly No. 886; State of New Jersey 217th Legislature. www.njleg.state.nj.us/ 2016/ Bills/A1000/886_I1.HTM.

Muoio, E. M., Gusciora, R., Huttle, V. V., & Conaway, H. (Pre-2016 Session). Assembly No. 887; State of New Jersey 217th Legislature. www.njleg.state.nj.us/2016/Bills/ A1000/887 _I1.HTM.

Muoio, E. M., Gusciora, R., Huttle, V. V., & Quijano, A. (Pre2016 Session). Assembly No. 888; State of New Jersey 217th Legislature. www.njleg.state.nj.us/2016/Bills/A1000/888_I1.HTM.

Christie, C. (2016, February 16). The Governor’s FY 2017 Budget: Budget summary. www.state.nj.us/ treasury/omb/publications/17bib/BIB.pdf.

Finley, B., & Catalini, M. (2016, February 16). Gov. Chris Christie’s budget, by the numbers. New Jersey Herald. www.njherald.com/article/20160216/ AP/302169582.

Huttle, V. V., Muoio, E. M., Gusciora, R., Wisniewski, J. S., Quijano, A., & Johnson, G. M. (2016, February 4). Assembly No. 2327; State of New Jersey 217th Legislature. www.njleg. state.nj.us/2016/Bills/A2500/ 2327_I1.HTM.

Huttle, V. V., Muoio, E. M., & Gusciora, R. (2016, February 4). Assembly No. 2328; State of New Jersey 217th Legislature. www.njleg.state.nj.us/2016/Bills/A2500/2328_I1.HTM.

Huttle, V. V., Wisniewski, J. S., Muoio, E. M., & Gusciora, R. (2016, February 4). Assembly No. 2329; State of New Jersey 217th Legislature. www.njleg.state.nj.us/2016/Bills/ A2500/ 2329_I1.HTM.

Gusciora, R., & Muoio, E. M. (2016, February 8). Assembly No. 2585; State of New Jersey 217th Legislature. www.njleg. state.nj.us/2016/Bills/A3000/2585_I1.HTM.

State of New Jersey. (2016, February 16). Governor Chris Christie’s Fiscal Year 2017 Budget Address as prepared for delivery. www.state.nj.us/ governor/ news/addresses/2010s/approved/ 20160216.html.

Stainton, L. H. (2016, January 28). Pros, cons, and regulatory policies for tiered health insurance networks. NJSpotlight. www.njspotlight.com/stories/ 16/01/27/pros-cons-and-regulatory-policies-fortiered-health-insurance-networks. Stainton, L. H. (2016, February 16). Opposition to Omnia continues to grow, as nurses join protest line. NJSpotlight. www.njspotlight.com/stories/

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THE LEGACY OF

40 YEARS LATER Steve Adubato and Rafael Pi Roman, co-hosts of New Jersey Capitol Report, interviewed the Honorable Paul W. Armstrong, MA, JD, LLM, retired Superior Court judge for Somerset County and noted bioethicist, about the Karen Ann Quinlan case and the unanimous Supreme Court ruling that allowed individuals “the right to die.” Pi Roman: As a lawyer, you represented the family of Karen Ann Quinlan, a case that ignited an international debate about end-of-life issues. Who was Karen Ann Quinlan, and why was her case so important? Armstrong: This case was a convergence of circumstances where medicine and science outstripped the law regarding the use of dialysis, respirators, chemotherapy or artificial nutrition and hydration to maintain life. Karen Ann Quinlan went into what is known as a persistent vegetative state or coma as a result of a lack of oxygen at age 21. Karen had no awareness of self or surroundings and no ability to communicate. Quinlan’s parents requested that she be disconnected from her ventilator as they believed it constituted extraordinary means of prolonging her life and it was causing her pain. Pi Roman: What was the court’s decision? Armstrong: The decision written by Chief Justice Richard J. Hughes says that each of us has a fundamental constitutional right to make decisions at the end of life. There is no constitutional right to die; the right is to make decisions while we are dying. Since Karen Ann Quinlan was incapable of making these decisions, her family could. If they did so by using an ethics committee, then no civil or criminal liability would attach to physicians and caregivers. Adubato: What was your experience representing the Quinlan family? Armstrong: I represented what I’ll characterize as a typical American family of devout Catholics. Karen’s devoted parents wrestled for quite a long time about whether it was a morally, theologically and ethically appropriate decision to remove the respirator. I was honored to have had the opportunity to assist the family with these very complicated decisions and legal issues.

Adubato: Richard J. Hughes claimed this was the most difficult issue he ever had to deal with other than the Newark riots. Describe his importance to this case. Armstrong: Richard J. Hughes was a Catholic and the only man to ever serve as Governor and Chief Justice. He was a true statesman for all New Jerseyans. When the Quinlan case was appealed, Chief Justice Hughes reached down and bypassed the appellate division out of deference to the family. Even while Hughes’ own wife was unwell, he put forth a tremendous effort to write what ended up being a unanimous decision embraced by all of our sister states. The first right-to-die case to reach the U.S. Supreme Court (Cruzan v. Director, Missouri Health Department) cited Justice Hughes’ decision for precedent, rather than the state courts citing the U.S. Supreme Court. Adubato: Now, 40 years after the decision, what is the legacy of the Quinlan case? Armstrong: At the time that this case was tried, there was no law on these right-to-die issues, and the whole world was watching. Karen had become every woman, and it was easy to empathize with her. She could be your daughter, sister or wife. The blessing of litigating it from 1975 to 1976 is that we had at the end of that legal trail Chief Justice Hughes, who wrote a decision that was translated into 64 languages. Every case that has wrestled with these issues since has followed the Quinlan case and the precedent written by Hughes. Steve Adubato, PhD, is a four-time Emmy Awardwinning anchor for Thirteen/WNET (PBS) and NJTV (PBS) and has appeared on the TODAY Show, CNN and FOX as a media and communication expert. Dr. Adubato co-hosts New Jersey Capitol Report with his colleague, Rafael Pi Roman. The full interview can be viewed at www.SteveAdubato.org.

MDADVISOR

The earth is splitting open into a grand chasm, and somehow, I am there falling backwards indefinitely until a sudden hypnic jerk returns me to bed. In that brief transition from wakefulness to sleep, the kinetic sensation of falling is so profound that my body is unaware of its position in time and space. Wide awake now, I can piece together the shadows and contours that fill my dark room. The earth has not fissured, and I am not falling. This May, I will graduate from physician assistant school, and with that, I will shed several components of my life that have defined me these past three years. Some I will part with happily: post-rotation exams, OSCEs, board review, clerkship. Other aspects of completing school will feel more bittersweet, like saying goodbye to my classmates whom I have bonded with, confided in and leaned on during difficult times. I have grown sentimental thinking of the PAs, doctors and nurses who have taught me the true value of kindness and patience. The provider I am becoming is a mosaic of these people, experiences and hardships–so many small pieces composing the whole figure. There is also fear. Right behind the excitement, the relief and the deep exhale of this final 100-meter dash is the fear of the unknown. Where will I work? More importantly, whom will I work with? Is the career I am starting now going to be the one I will still be in in 5, 10, 20 years from now? The versatility

MDADVISOR | SPRING 2016

By Emily Weinick, PA-S of the physician assistant position affords me the opportunity to ask these questions, as many of my mentors have worked in fields ranging from liver transplant to emergency medicine all within the span of a decade. I know that one of the major keys to success in this transition is for me to start in a place where people want to teach me. Though I will be shedding the PA-“S” of student for the PA-“C” of certified, I will do so knowing that my capacity to learn has just begun. Physician assistants traditionally do not complete residencies, though several are available throughout the country. This means that finding the right fit is crucial as a new graduate. It would be detrimental to me and to my patients to start a career in a place where people are complacent and unwilling to teach. I was drawn to the medical field because there is no beginning or end to it. There is a continuum of science, innovation and passion that is improving lives in every part of the world. No wonder in those early moments of sleep I can’t help but feel as though I am falling into the abyss: My mind is limitless even if my body is still. Emily D. Weinick, PA-S, is a physician assistant student at Seton Hall School of Health and Medical Sciences, Class of 2016, and a 2015 Edward J. Ill Excellence in Medicine Scholarship Recipient.

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