ACMS Bulletin, November 2021 by TEAM

ALLEGHENY COUNTY MEDICAL SOCIETY

Bulletin November 2021

Barriers to Hospice Care in the United States

Bulletin Medical Editor Deval (Reshma) Paranjpe (reshma_paranjpe@hotmail.com) 2021 Executive Committee and Board of Directors President Patricia L. Bononi President-elect Peter G. Ellis Vice President Matthew B. Straka Secretary Treasurer Raymond E. Pontzer Board Chair William K. Johnjulio DIRECTORS 2021 Douglas F. Clough William F. Coppula David J. Deitrick Kevin O. Garrett Marcy L. Jackovic 2022 Ragunath Appasamy Mark A. Goodman Keith T. Kanel Maria J. Sunseri G. Alan Yeasted 2023 Steven Evans Bruce A. MacLeod Amelia A. Paré Maritsa Scoulos-Hanson Adele L. Towers PEER REVIEW BOARD 2021 Marcela Böhm-Vélez Thomas P. Campbell 2022 Kimberly A. Hennon Jan W. Madison 2023 Lauren C. Rossman Angela M. Stupi

PAMED DISTRICT TRUSTEE G. Alan Yeasted COMMITTEES Awards Mark A. Goodman Bylaws Matthew B. Straka Finance Keith T. Kanel Gala Mark A. Goodman Membership Peter G. Ellis Nominating Bruce A. MacLeod

ADMINISTRATIVE STAFF Interim Chief Executive Officer Lisa Olszak Zumstein (lisa@acms.org) Vice President, Operations and Physician Services Nadine M. Popovich (npopovich@acms.org)

Associate Editors Douglas F. Clough (dclough@acms.org) Richard H. Daffner (rdaffner@acms.org) Kristen M. Ehrenberger (kehrenberger@acms.org) Anthony L. Kovatch (mkovatch@comcast.net) Joseph C. Paviglianiti (jcpmd@pedstrab.com) Anna Evans Phillips (evansac3@upmc.edu) Maria J. Sunseri (mjsunseri@msn.com) Andrea G. Witlin (agwmfm@gmail.com)

ACMS ALLIANCE Co-Presidents Patty Barnett Barbara Wible Recording Secretary Justina Purpura Corresponding Secretary Doris Delserone Treasurer Sandra Da Costa Assistant Treasurers Liz Blume Kate Fitting

EDITORIAL/ADVERTISING OFFICES: Bulletin of the Allegheny County Medical Society, 850 Ridge Avenue, Pittsburgh, PA 15212; (412) 321-5030; fax (412) 321-5323. USPS #072920. PUBLISHER: Allegheny County Medical Society at above address. The Bulletin of the Allegheny County Medical Society is presented as a report in accordance with ACMS Bylaws, Articles 6, 8, and 11. The Bulletin of the Allegheny County Medical Society welcomes contributions from readers, physicians, medical students, members of allied professions, spouses, etc. Items may be letters, informal clinical reports, editorials, or articles. Contributions are received with the understanding that they are not under simultaneous consideration by another publication. Issued the third Saturday of each month. Deadline for submission of copy is the SECOND Monday preceding publication date. Periodical postage paid at Pittsburgh, PA. Bulletin of the Allegheny County Medical Society reserves the right to edit all reader contributions for brevity, clarity and length as well as to reject any subject material submitted. The opinions expressed in the Editorials and other opinion pieces are those of the writer and do not necessarily reflect the official policy of the Allegheny County Medical Society, the institution with which the author is affiliated, or the opinion of the Editorial Board. Advertisements do not imply sponsorship by or endorsement of the ACMS, except where noted. Publisher reserves the right to exclude any advertisement which in its opinion does not conform to the standards of the publication. The acceptance of advertising in this publication in no way constitutes approval or endorsement of products or services by the Allegheny County Medical Society of any company or its products. Annual subscriptions: $60

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ALLEGHENY COUNTY MEDICAL SOCIETY

Bulletin

NOVEMBER 2021 / VOL. 111 NO. 11

Opinion

Departments

Articles

Editorial .............................. 312 Membership Benefits.......... 324 Materia Medica ....................330 Grace Deval (Reshma) Paranjpe, MD, FACS

Semglee® (Insulin Glargine)

Classifieds .......................... 326 William Beathard, PharmD and Samantha DeMarco, PharmD, BCPS

Editorial ..............................314 Alliance News ..................... 328 The Slingshot Joseph Paviglianiti, MD

Allegheny County Medical Society Alliance Holiday Party and Dinner December 9

Editorial ..............................316 Medical historic vignette: Child abuse Richard H. Daffner, MD, FACR

Society News ...................... 328

• 30th Annual Virtual Clinical Update in Geriatric Medicine set for March 31 Perspective ........................ 319 April 1, 2022 Let’s talk about prior auth! • Pittsburgh Ophthalmology Society Sharon L. Taylor, MD announces upcoming monthly meetings

Legal Report ......................332 Anatomy of a False Claims Act Suit: U.S. ex. rel. D’Cunha v. Luketich et al. Beth Anne Jackson

Special Report .....................334 2021 PAMED House of Delegates Report

Special Report .....................336 Reportable Diseases 2021: Q1-Q3

Perspective ........................ 322 Barriers to hospice in the United States Keith R. Lagnese, MD, FAAHPM, HMDC

Career Opportunity .............338

For up-to-date resources on COVID-19, visit: www.acms.org/covid-19-resources

On the cover

2022 Bulletin Photo Contest Winners Page 327

Executive Director, Allegheny County Medical Society

Pittsburgh Reflections at Sunset Mark E. Thompson Dr. Thompson specializes in cardiology.

Editorial

Grace DEVAL (RESHMA) PARANJPE, MD, MBA, FACS “This is what happens when the whole world is running on empty.” I can’t help but think that, looking at the world around us lately. The news is full of incidents of our fellow humans failing to regulate their emotions. The ability to regulate our emotions is what separates adults from toddlers and is the bedrock of a civilized society. And yet, there are tantrums being thrown all around us. We have reached the stage in the pandemic where the phrase of the day is no longer “everything is awful,” but “everyone is awful.” Think about a toddler in the throes of the terrible twos. Said Toddler might be hungry, sad, angry, hurt or confused. However, Said Toddler does not have the tools to stop, notice and name his or her emotion – let alone the self-awareness to validate those emotions, understand that they can change and feel better, and self-soothe. End result? Thrown spaghetti, tears of rage, screaming, shrieking and a general meltdown that ruins everyone else’s experience. Luckily, most of us transition out of that phase and learn the regulatory skills that allow us to progress to functional adulthood. However, in periods of stress, adults are known to regress. Perhaps you have heard that we are undergoing a societal phenomenon known as the Great 312

Resignation. I feel we are also undergoing a Great Regression—each of us in our own way and to different degrees. Consider the increasing daily news stories involving airplane rage---entitled and/or drunk passengers punching flight attendants who are merely asking them to comply with routine instructions. The cumulative irritation of the populace at having to wear a mask and get vaccinated and show a vaccine card is like that of a toddler being told he must finish dinner before he can have dessert. Combine that with the baseline annoyances and indignities of modern airline travel and you get an impending explosion. Pressure always vents through the weakest spot; similarly, angry travelers take out their anger at readily available soft targets who oppose their behavior: the flight crew, whose job it is to maintain civilization in the air. No one considers the plight of the flight crew beyond a passing horror at a hapless flight attendant losing teeth during an attack. Don’t they feel like punching back? Like quitting? I’m sure they do. Wouldn’t you? Yet they keep on going, because they need the paycheck and the health insurance, and because at one point aviation was their dream. It becomes a tainted dream when the public you seek to serve in the friendly

skies rewards your hard work, devotion, and the routine existential risks you take in your job by punching you in the face. The flying public may applaud when police drag Said Toddler off the plane, but do they police themselves or fight for better protections for flight crews? In health care, our stories are similar. Combine pandemic frustrations with ERs at capacity and restrictions and staff shortages with the routine indignities and fear of being a patient and you get a powder keg in search of match. We are the readily available soft targets for the boil-over of their accumulated frustration. Patients are screaming and venting like never before at staff who are themselves overwhelmed and on their last straw. Staff may blow up at each other, sometimes in front of patients. There are no easy solutions or resolutions. Relief is an abstract concept: it will come someday, surely, but not anytime soon. Staff may quit. Physicians may quit. The general public isn’t policing itself or fighting for us or protecting us. The pandemic had a predictable response in many people, along the lines of Elizabeth Kubler Ross’s five stages of grief, namely Denial, Anger, Bargaining, Depression and Acceptance. Denial: “Covid isn’t real. People are overreacting. This is a hoax. It won’t www.acms.org

Editorial Perspective happen here.” Anger: “Masks are stupid. You can’t make me take a vaccine. Social distancing is bad for my mental health, not to mention my business.” Bargaining: “If I take this vaccine, can we get back to normal life now?” Depression: “People are dying. Vaccines aren’t perfect. Life still isn’t normal. Things are bad.” Acceptance: “Yes, Covid is real. Vaccines aren’t perfect but they are a good defense. Life is scary and different and inconvenient now. But I can adapt, and I will find a way through, and I will be happy again and get my needs met.” Most of us are moving on through Depression to Acceptance while we live in this period of limbo before either our world returns to normalcy or we reinvent our ways of living. The Said Toddlers among us adults are ping-ponging between the Anger and Bargaining stages. At its worst, this manifests as airplane and road rage, domestic violence, alcoholism, drug abuse and other forms of “acting out,” self-medicating and dysfunctional attempts at self-soothing. Alcohol use has increased among patients through the pandemic along with anxiety, likely as self-medication. Domestic violence has increased. Divorces are becoming rampant; being stuck in the house together for nearly two years has forced confrontations with long simmering problems; when not solvable, one or both parties seek escape. Sometimes it can just be a matter of boredom and wanting something “different and better.” More benign versions of this phenomenon look like someone yelling something along the lines of “I’m mad as hell, and I’m not going to take it anymore!” figuratively or literally pouting,

ACMS Bulletin / November 2021

or even saying “I don’t like this anymore! I quit!” It is the equivalent of saying “I’m going to take my toys and go home!” It undoubtedly feels fantastic in the moment, but is solipsistic and disregards the impact of the behavior on others in the ecosystem, whether family, friends or co-workers. Perhaps that’s the point: faced with death and uncertainty, many think: “The world will go on without me, anyway. I might as well do what feels good in the moment.” The Great Resignation is, at some level, a way of self-soothing. Some may sell their houses in a hot market and downsize. Some may start a business. Some may choose to have children. Some may choose to marry. Some may choose unusual lifestyles. Some may run for office. Some may retire from public life altogether. The key question is: are you looking for a change because you are bouncing between Anger, Bargaining and Depression? Like a toddler who can’t identify emotions or self-soothe, are you looking for something, anything to make you feel better? Or are you making changes because this period of limbo has truly put you back in touch with your true self, and you are making the changes you have always wanted to make if given a choice? Do you have a solid, thoughtful plan? If so, more power to you. Think of the future, because there will be a future when the pandemic ends, and it may be completely different than what you anticipate today. Meanwhile, what can we do to make Everything and Everyone less awful? Give others grace whenever you can. Give them a pass; realize that they are as stressed and overwhelmed as you are. (Obviously, this does not apply if

they attempt to punch you in the face.) Be grateful when others give you a pass. Start a love chain. As clichéd as it seems, it does work. No matter how exhausted you feel, set in motion a chain of kindness with a small favor and small act of love. When everyone is running on empty, one small act of love can reignite the spark in a fellow human. Acts of love reinforce and reawaken our humanity. Emotional energy is in short supply, listening can be draining and large acts of caring can be difficult when you are worn out—but the small gift of a genuine smile and a kind word can work miracles. Do a favor whenever you can, whatever size it may be. A friend is doing a favor for me, so I am doing a favor for another friend without hesitation and with gladness. Paying it forward is a simple way to spread joy and decrease the stress and anxiety and awfulness of our current situations. And the lovely thing about paying it forward is that in this circular world, good is certain to come back to you at some point. This way, if you feel there’s no good left in the world, you have only to look in the mirror to know it exists. And if you should ever look in the mirror and see Said Toddler, remember that providing distractions, ice cream and hugs can also work miracles. Dr. Paranjpe is an ophthalmologist and medical editor of the ACMS Bulletin. She can be reached at lissamine@gmail.com. The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

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Editorial Perspective

The Slingshot JOSEPH PAVIGLIANITI, MD have been thinking about my legacy a lot lately. I’m not really sure why, but over this last year or two, I find myself reflecting a lot on what my legacy will be to my children and to my community, and perhaps, presumptuously, to the world. How will I be remembered? What stories will my kids tell about me to their kids? When I die, will anyone care? Did I make a difference? The idea of “leaving behind a good legacy” strikes me as similar to the idea of funerals and wakes. Legacies and funerals are constructs “for the living” and exist for those left behind, as a way to comfort and begin the process of closure. When you’re dead, you really don’t care what kind of casket you are in or what they say about you. But those you leave behind do. Similarly, when I’m pushing up daisies, I won’t care about the legacy I leave behind. But while I’m alive, the concept of building up a strong legacy reassures me that when my time comes, I will die “at peace.” Whilst some of us might want to “go out with a bang” while doing something heroic, I presume that most of us want to die peacefully, with few regrets and many of our goals accomplished. We hope for the cinematic matriarchal death scene, surrounded by our families as we slowly slip into oblivion, knowing that our loved ones are cared for, and that we lived the life that we were intended to live and put

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to use all the gifts and talents we were given. We ran a good race and crossed the finish line before the finish line came to us. About 12 years ago, while in my mid-40’s, I started reading The Last Lecture by Randy Pausch, a CMU computer science professor with terminal pancreatic cancer. He and his wife had delivered their third child just months earlier when he got the news of his cancer diagnosis; after some quick research on the dismal prognosis of pancreatic cancer, his priorities instantly changed. He needed to make sure his young family was provided for after he was gone. After that, he wanted a chance to be able to talk to his kids “from beyond the grave” and give them some fatherly advice when they were old enough to need it and understand it. But life in your mid-40’s is busy: young kids, homework, chauffeuring to sports and school events, medical practice in full swing, “on call” responsibilities that take up what little free time you have, patients that need help after hours or late in the clinic day such that you miss (or are really late to) all those great sports contests, school band concerts, birthdays, etc. The list is endless. You will note I left “spending time with one’s spouse” off the list, because, sadly, spouses are often left off the list, or at least shoved really far down

it. I could not be a successful physician and father without my wife filling in the many places where I fall short. The career we have all chosen takes us away from our families far more than the average parent. Our kids and our spouses get the short end of our time-stick. It’s tough being a spouse to a physician. In the old days, parents wanted their kids “to marry a doctor; I’m not sure I would give that advice to my own children. While I am generally happy with my choice to become a physician, by far the smartest and most important decision I ever made was not to become a physician, but rather to wait patiently until I found the right person to spend my life with…and to build my legacy with. I won the wife lottery. Anyway, I only got a few chapters into the Pausch book before getting distracted with “life.” I got sidetracked and forgot about it. For years. But, it’s a decade later now and I’m clearly on the downward descent of the arc of my life. Hopefully it’s a long, graceful arc, but one never really knows, do we? So, now in my mid-50’s, I went on a mad hunt, found the Pausch book and started it again. And it’s got me thinking. If I were to die before my kids were all “fully cooked,” how can I reach out from beyond the grave and have a presence with my kids and dispense fatherly advice posthumously? www.acms.org

Editorial Perspective There are many good points to the book, but the basic premise is: stop wasting time, focus on your life goals, figure out your dreams and work with single-minded focus to fulfill some/most of them. Show gratitude, stop complaining, suck it up and work harder. See your world half full, not half empty. Don’t give up. Well, that’s easy advice to give, but hard to put into action. While we need to work to have the means to accomplish some of our goals, if all we do is work, and never get around to goal fulfillment, what was the point? Admittedly, this is something that my wife and I are often at odds about. As physicians, most of us are experts at delayed gratification. Then, as we start our careers, it’s time to join the rest of the world on… living. New car, house, marriage…later some kids. Before we know it, we are on an incline treadmill of house, school, credit card, and auto payments. The “home treadmill” gets faster every year. Here come more kids. Here comes college tuition. So, we crank up our careers and our “work treadmill” speeds up. Add in some prior authorizations and EHR, and burnout eventually at work and at home. I sometimes feel like everyone gets a piece of me… except me. If you ask my patient wife, she feels as if she gets none of me, or maybe just a few crumbs. I haven’t found the off switch to either treadmill. People talk of slowing down the treadmill, but that is difficult to do. In my garage, there is a 5-foot-tall tree branch that is shaped like a slingshot at one end. When my oldest son, Daniel, was 5, he loved reading Calvin and Hobbes. There was an episode where Calvin and Hobbes make a slingshot to hurl something at Calvin’s nemesis, Susie. For some reason, Daniel thought ACMS Bulletin / November 2021

that was a great idea. Somewhat serendipitously, we found a fortuitously slingshot-shaped tree branch and we soon thereafter decided we were going to make a slingshot; his plan was to aim it at his 3-year-old sister, Anna, with some chocolate pudding, but pretend it was poop. Dan thought the plan was uproariously funny, and I have to admit, I enjoyed sitting with him while he drew up a stick figure battle plan. We waited for our perfect moment. The tree branch/ slingshot was propped up inside our garage waiting to take Anna by surprise. A few months ago, we were packing up Dan, now 23, to move into his first “post college/first real job” apartment. He saw the tree branch / slingshot near the garage door and asked me why I had kept it, as we clearly never were going to fulfill the pudding/poop slingshot assault plan on his sister, especially since she had found out about the plan (five-year-olds cannot keep secrets). He knows I am a hoarder, but an 18-year-old tree branch shaped like a slingshot seemed a bit excessive, even to him. He had asked me why I kept it several times during those 18 years, but I never owned up as to why. But now he was moving out, and I needed to confess. I admitted to him that tree branch represented all my many failings as a father: all the time I wanted to spend with the kids, but couldn’t. All the plans we would make to do things, but never get around to. All the good advice I wanted to give them, but couldn’t put into words at the right moment. All the trips to cool places we should have gone, but couldn’t. There were always things that got in the way: Work. Chores. The Lawn. Work. Obligations. Bills to pay. Work. Lack of funds. Work. Taxes or paperwork to do.

House Maintenance. Did I mention work? Always seemingly more important stuff that got in the way of the father/husband I envisioned myself being when I dreamt about it as a starry-eyed teenager. The tree branch/slingshot has remained my reminder that I can always do better and that I am far from perfect. When I die, I want Dan to have the slingshot to inspire him to be a better parent than I was able to be. Or maybe they will bury it with me, so I can take my shortcomings with me. So, as I sit here contemplating what sort of legacy I will leave to my family and to the outside world, I think Pausch got it right. Live as if our days are numbered and commit to trying to fulfill some life goals, for our time may be very limited. I am making “slowing down” a priority with a start date. I also am adopting the idea of beginning to keep some sort of written legacy of family history, quotes and bible verses that resonate, words of wisdom, etc., that the kids can refer to long after I am gone, when they might be facing problems I faced. Right now they don’t want to hear it…but, maybe later. Memory fades, but the written word can span generations. What made me tick? Why did I do the things I did? Why did I work so hard at the expense of fun? Why was providing for my family such a priority? Hopefully, they will come to the conclusion that there was much more to me than just an unused slingshot. Dr. Paviglianiti is a pediatric ophthalmologist and associate editor of the ACMS Bulletin. He can be reached at jcpmd@pedstrab.com. The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, Continued on page 316 or the Allegheny County Medical Society.

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Editorial Perspective

Medical historic vignette: Child abuse RICHARD H. DAFFNER, MD, FACR “When something has to be done, forget about your principles and do what is right.” C. Henry Kempe, M.D. hild abuse has been an unfortunate part of society since the dawn of human evolution. Child abuse may take the form of physical, sexual, or psychological maltreatment, or neglect. Child labor, sex trafficking, or forcing children to act as soldiers are additional examples of child abuse. Although the abuse of children was a well-known occurrence, there were virtually no written descriptions of it until Charles Dickens published Oliver Twist in 1838. Significantly, and surprisingly, the medical community, although aware of the heinous practice, chose to ignore it. This changed, however, in 1860 with the publication of a paper1 in a French medical journal by Auguste Ambroise Tardieu (1818 – 1879). This Editorial will discuss Tardieu and two other medical pioneers in bringing child abuse to light in the medical literature: John Caffey (1895 – 1978) and C. Henry Kempe (1922 – 1984). Auguste Ambroise Tardieu (fig. 1) was born March 10, 1818, in Paris and earned his medical degree at the Faculté de Médicine de Paris. His entire career was spent in Paris, where he

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Fig. 1 Ambroise Tardieu (1818 – 1879) was Dean of the faculty of Medicine and Professor of Legal Medicine at the University of Paris. He was also the President of the French Academy of Paris. His specialties were forensic medicine and toxicology, and he was considered the Chief Medical Examiner of the City of Paris. He published extensively, based on his having performed over 5,000 post-mortem examinations. His forensic analyses covered a diverse collection of subjects, including rape, abortion, drowning, hanging, homosexuality, poisoning, suffocation, syphilis, and the first report in the medical literature on child abuse1. His most famous works were a book on forensic toxicology, that quickly became a reference, and a book on the forensic

aspects of sexuality and sex crimes. The final part of the latter work, on “pederasty” was considered a classic study in the history of homosexuality. Tardieu’s detailed descriptions of physical and sexual abuse (rape) of children, although graphic, were, unfortunately, largely ignored or sharply criticized by the legal authorities. Furthermore, the medical community of his time failed to recognize the prevalence of child abuse. Child victims were condemned to suffer abuse and neglect for nearly another century. Despite this, however, Tardieu’s legacy is that the “Battered Child Syndrome” is also known as Tardieu syndrome. Furthermore, the finding of subpleural ecchymoses following the death of a child by strangulation are called Tardieu ecchymoses. John Caffey (fig. 2) was born March 30, 1895, in Castle Gate, Utah (now a coal-mining ghost town 90 miles southeast of Salt Lake City). He attended the University of Michigan School of Medicine, where he received his medical degree in 1919. Following an internship in internal medicine at Barnes Hospital in St. Louis, in 1920 he volunteered with the American Red Cross and American Relief Administration in Eastern Europe (Poland and Serbia) and served for www.acms.org

Editorial Perspective

Fig. 2 John Caffey (1895 – 1978) three years. He returned to the United States for additional residencies in Medicine at the University of Michigan and in Pediatrics at Columbia, in New York City. While in private practice of pediatrics at the old Babies Hospital (Columbia) he became interested in radiology, which led him to be asked, in 1929, to develop a department of pediatric radiology. Dr. Caffey’s intelligence and inquiring mind resulted in him being recognized worldwide as the preeminent leader in pediatric x-ray diagnosis. The first edition of his classic book, Pediatric X-ray Diagnosis was published in 1945. This text has morphed into a multi-authored work in two volumes, now in its 13th edition. He retired from Babies Hospital in 1960, and in 1963 joined the staff at Children’s Hospital of Pittsburgh as Visiting Professor of Radiology and Pediatrics at the University of Pittsburgh School of Medicine, where he remained until his death on September 2, 1978. Dr. Caffey made many contributions to the pediatric radiologic literature. Among these were his observation that the presence of a

Fig. 3 C. Henry Kempe (1922 – 1984) prominent thymic shadow on a chest radiograph was a normal finding (resulting in an end to irradiation of the thymus in infants), a description of infantile cortical hyperostosis (“Caffey Disease”), a condition often confused with “congenital” syphilis, his description of Vitamin A poisoning, and his description of the early radiographic changes of avascular necrosis (Perthes Disease) of the hips. But his greatest contribution to medicine and to society was his correlation of multiple bone fractures in infants suffering from chronic subdural hematomas2 in 1946. Dr. Caffey was the first to raise the specter of child abuse in these patients (“Battered Child Syndrome”). This paper was one of the 100 most-cited articles from the first century of the American Journal of Roentgenology and influenced other investigators to look further into the subject of child abuse3,4. The John Caffey Society, whose members are pediatric radiologists who either worked with Dr. Caffey or were trained by him, was formed in 1961. This society is one of the most prestigious radiologic organizations.

C. Henry Kempe (fig.3) was born April 6, 1922, into a Jewish family in Breslau, Germany (now Wroclaw, Poland). With the rise of the Nazis to power, the family emigrated to England in 1937, and then to the United States, where the family settled in California. Henry attended the University of California at Berkeley and entered the UC School of Medicine at San Francisco (UCSF) in 1942. Upon graduation in 1945, he interned in pediatrics and then was inducted into the US Army, where he served at the Army Medical Research and Graduate School in Washington, DC. Following discharge from the army, he completed his residency in pediatrics at Yale. It was there that he met his wife, Ruth, a pediatric psychiatric resident. Following his residency, he returned to UCSF as Assistant Professor of Pediatrics. In 1956, at the age of 34 years, Dr. Kempe was appointed Professor and Chairman of the Department of Pediatrics at the University of Colorado School of Medicine. There, he built his department to an academic powerhouse. Although his initial area of interest was in infectious diseases, his love for children led him to become an advocate for recognition and prevention of child abuse (non-accidental trauma) and neglect. Working with local authorities, he demanded better diagnostic investigation of unexplained and life-threatening injuries observed in several local emergency rooms – fractures, burns, and brain damage. This resulted in the publishing of his landmark paper in 19623. In 1972, he and his wife founded the National Center for the Treatment and Prevention of Child Abuse (now called the Henry Kempe Center) in Denver. Continued on page 318

ACMS Bulletin / November 2021

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Editorial Perspective From page 317 ––––––––––––––––––– Unfortunately, Dr. Kempe died unexpectedly while vacationing in Hawaii March 8, 1984, at the age of 61. The Kempe Award, established in his memory 1984, is presented by the International Society for the Prevention of Child Abuse and Neglect (ISPCAN) every two years to an outstanding professional or organization working in the field of child abuse and neglect. The Caffey-Kempe syndrome is another name for battered child syndrome, joining the earlier Tardieu syndrome. Three men of medicine, a pathologist, a radiologist, and a pediatrician, born nearly a century apart, made significant contributions to the recognition and prevention of child

abuse. Unlike those men of science and medicine who used their training and skills for nefarious purposes5, these pioneers fought the trend of ignoring the topic of child abuse. Dr. Daffner is a retired radiologist who practiced at Allegheny General Hospital for over 30 years. He is Emeritus Clinical Professor of Radiology at Temple University School of Medicine. He is also an amateur historian. The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

References: 1. Tardieu A. Étude médico-legal sur les sévices et mauvais traitment exercés sur des enfants, (Forensic study on cruelty and the maltreatment of children). Annales d’hygiène publique et de médecine légale, 1860;13:361-398. 2. Caffey J. Multiple fractures in the long bones of infants suffering from chronic subdural hematoma. AJR Am J Roentgenol 1946; 56:163-173. 3. Kempe CH, Silverman FN, Steele BF, Droegemuller W, Silver HK. The battered child syndrome. JAMA 1962; 181:17-24. 4. Silverman FN. Unrecognized trauma in infants, the battered child syndrome and the syndrome of Ambroise Tardieu. Radiology 1972; 104:337-353. 5. Daffner RH. Rightly forgotten. ACMS Bulletin 2020 December pp 365-367.

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Perspective Perspective

Let’s talk about prior auth! SHARON L. TAYLOR, MD rior authorization is a process where providers must obtain approval for coverage from payers before treatment with a procedure or medication. At its best, prior authorization (PA) is an effective utilization management (UM) tool to reduce unwarranted or inappropriate care and its associated costs and complications thereby improving the quality and cost of care for insured clients. At its worst it is a barrier to excellent patient centered care delaying needed treatment and diverting time and resources away from direct patient care. It can undermine the doctor patient relationship causing treatment hesitation thereby increasing costs and complications arising from delayed or abandoned needed care. As with most disagreements, the truth is a matter of perspective and likely falls somewhere in between. In areas of medicine where the medical community has been slow to adopt best practices, for example by continuing to perform procedures with no proven benefit, these methods can be highly effective and actually drive excellence and efficiency in medicine. Modern data analysis tools identify trends in care counter to best practice or areas of potential fraud and abuse

where prior authorization could be corrective. Indiscriminate use, however, can delay needed care and drive costs up in an unnecessary and even harmful manner. Recently, the AMA and other organizations have identified that prior authorization is being overused and abused. Current practices are often countering the now quintuplet aim of improving public health, correcting inequity, decreasing costs, and enhancing patient and provider experience of care. In many cases, the goal seems to be maximizing gains by third parties and insurers at the expense of the consumer and provider of healthcare. In response the AMA, with a work group representing 17 other physician organizations, drew up 21 principles of PA and UM reform endorsed by over 100 additional state and national healthcare societies or organizations. Subsequently a consensus statement from organizations representing physicians, insurers, pharmacists, medical groups, and hospitals identified five areas of meaningful opportunity for reform. This second document does not address all the 21 principles, but if the industry followed this blueprint for reform fully, we would not need legislation and regulation.

Calls for legislative relief to mandate an automated, standardized approach with clearly defined circumstances and criteria for implementation are growing. Recent legislation passed in Texas is extremely restrictive and is being held up as a model for other states by many of these endorsing organizations. This law, however, may be so strict as to negate appropriate UM tools to the point of driving insurers out of those markets reducing competition and driving insurance and healthcare costs higher. The best legislation would strike a balance to limit fraud, abuse, and inappropriate care while at the same time driving forward evidenced based medical care in a way that supports the doctor patient relationship, facilitates compliance, and reduces barriers to accessing timely care. It shouldn’t be the white knight doctor going into battle with the insurance company only to find, after winning the fight, the damsel in distress has died or lost interest. Aetna’s implementation in July 2021 of universal prior authorization nationwide for all cataract surgery is an example of a worse case scenario in prior authorization. Cataract patients and ophthalmology have become an object lesson to all providers and Continued on page 320

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Perspective Perspective From page 319 ––––––––––––––––––– patients. First, let’s discuss the choice of cataract surgery. While it is among the most commonly performed surgery in the U.S. at about 3 million per year, it is not rife with abuse. There is no controversy about efficacy or indication in contrast to many other surgeries. Aetna’s representative quoted an estimate of 20% unnecessary surgery countered by the American Academy of Ophthalmology’s 3% estimate. In either case, no more than two procedures per patient are possible, so as compared to other procedures, the potential for abuse is by definition limited. Additionally, cataracts are expected in the majority of patient’s lifetimes, so it is a matter of when and not if it should be performed. Delaying cases never reduces the need for surgery, as there is no potential for cataracts to improve over time. Complications are relatively rare and so there is minimal cost reduction. It is unlikely that PA of cataracts will provide a meaningful savings for any of the parties involved including Aetna, making it a poor choice for review. We could go through the exercise of discussing all the ways this was a poorly executed and flawed business decision. It is only a matter of time before MBA and MPH programs begin using this as a case study. Let’s save you a very boring read, in case you aren’t an MBA type, and just list the pitfalls we have experienced: • Poor choice of procedure targeted for costs savings • Lack of selective targeting of likely abusers/outliers • Lack of transparency in an overly complex PA processes 320

• Lack of consistency in PA processes • Lack of appropriate testing or piloting of automated systems resulting in systematic inappropriate denials and delays of care (e.g. denials for second eyes as duplicate requests) • Lack of training and education on processes for provider staff • Inadequate infrastructure to support exceptions/appeals or to expedite urgent cases • Inadequate infrastructure in place to provide timely processing of a known and expected quantity of requests • Poor responsiveness and transparency in correcting these failures leading to a confusing patchwork of fixes and workarounds • Failure to leverage integrated technology such as EHR into the PA process If legislation or insurance regulation were drafted to protect patients and providers from these pitfalls, all would be well served. Care must be taken to still allow appropriate tools for quality improvement and utilization oversight in that they advance common goals discussed earlier, but protections need to be put in place as soon as possible. All physicians and patients should learn from this object lesson and take action. A common argument against any governmental regulation is that in a free market economy the marketplace should correct this problem. Medicine, however, is not a free market. The entity paying for the service is not the entity receiving the service. Further, the consumer cannot gain the knowledge to make a fully informed

choice and must rely on expert guidance. When the insurance company and the provider appear to be at odds about what is appropriate care, the patient is caught in the middle and doesn’t know whom to trust. The relationship between trust and healthcare outcomes is complex, but higher trust in providers leads to better patient satisfaction and higher reported quality of life and perceived outcomes. Even excellent care is undermined in a measureable way by lack of confidence. If we can’t at least seamlessly move PA and UM into the background so that the patient is unaware of the mechanisms in place, we are likely doing more harm than good. I expect Aetna will experience a poor return on investment and see the folly of this program in due time. Meanwhile, cataract practices in markets where Aetna has a significant share of patients are in crisis. Cataract surgery has already faced significant reimbursement cuts with more on the horizon. Some practices may not survive the ongoing increased costs of this PA burden or the resulting loss of income if they stop providing cataract surgery to these patients or drop Aetna altogether. Aetna patients are being denied timely, appropriate access to one of the most efficient and effective procedures in medicine. Both patients and providers need to make noise. Every patient and surgeon affected by this needs to contact their state and federal legislatures and tell their stories. They should contact Aetna and complain. They should choose a different insurance if they have the option. They should contact their local www.acms.org

Perspective Perspective newspapers or write letters to the editors to tell their story. All other providers and patients should learn from Aetna’s demonstration of prior authorization gone wrong. We must call for a legislative and regulatory solution. Currently there are bills at both the state (SB225) and federal (HB3173) level to address these concerns. I urge you to contact your state and federal legislators today to draw their attention to the concern, educate them about increasingly aggressive and abusive prior authorization, and ask them to support bills enacting regulation and

oversight of prior authorization before your specialty becomes the next object lesson. Ask your family, friends, and patients to do the same. If they are supportive, thank them. If they are not, try to learn why and debate the merits of their argument. We cannot leave this advocacy work up to others. We must all do our share. Prior authorization, at its best, can raise quality and lower overall costs of healthcare. Unfortunately, health care insurance providers and administrators interests don’t always align with the greater good. Aetna’s cataract prior authorization program makes it clear

that regulation is needed. In the end, it remains our responsibility to ensure the best care for our patients and practices. Sharon L Taylor, MD, is President of the Pennsylvania Academy of Ophthalmology. She can be reached at president@paeyemds.org. The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

www.acms.org OUR SYSTEM or YOUR SYSTEM? It’s up to you. • Physician Billing Services for All Specialties We would use OUR billing system or YOUR billing system based on YOUR preference. • Credentialing Services for All Specialties • Accounts Receivable Follow-Up for Practice Support :H ZRXOG ZRUN \RXU DFFRXQWV RQ \RXU V\VWHP WR PD[LPL]H FDVK ÀRZ NEW Billing Client Example: A new client (a 6-physician family medicine group) liked their EHR, so the group asked us to bill using their ELOOLQJ V\VWHP %HVLGHV WKH EHQH¿W RI NHHSLQJ WKHLU (+5 WKH JURXS LV QRZ H[SHULHQFLQJ JUHDWHU H൶FLHQF\ DQG VWDELOLW\ LQ WKHLU R൶FH by eliminating problems FDXVHG E\ ELOOHU WXUQRYHU YDFDWLRQV GLYHUVLRQ DQG RWKHU WLPH R൵ Contact Ruby Marcocelli, Vice President at 412-788-8007 or rmarcocelli@fennercorp.com

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Perspective Perspective

Barriers to Hospice Care in the United States KEITH R. LAGNESE, MD, FAAHPM, HMDC During National Hospice Month this November, I remain very pleased that the ACMS Bulletin continues to support articles relevant to this important component of healthcare delivery in our country. Although hospice utilization continues to rise annually in the United States, there remain significant barriers to accessing hospice care. These range from patient and provider myths, constraints of the Medicare Hospice Benefit, as well as persistent social and cultural inequities. I would like to not only identify these from a current and historical perspective, but also provide thoughts and ideas on how hospice access can be improved locally and nationally. It might be helpful to see how these barriers looks from different lenses below (in no particular order): Patient: Hospice = ‘Giving up’ My normal doctors can’t be involved once I enroll. I have to stop most of my meds. I can’t get treatment/monitoring of my health conditions. It’s too early for hospice- I’m not dying yet. Treating Physician(s): I don’t want my patient to give up hope. I don’t have the time/skills to have these 322

difficult conversations. I won’t be able to treat my patient nor get compensated for such. Hospice and Home Health Teams: Patient is ‘not on the hospice page.’ Patient is still full code. “They just don’t get it.” Not sure if they qualify. Their doctor(s) won’t call us back/make a referral. The above perceptions and biases are not novel, but have remained pervasive since the inception of the Medicare Hospice Benefit (MHB) nearly 40 years ago. Unfortunately, they continue to create barriers to hospice access, as well as delay referrals to hospice care. On a positive note, the MHB began as a model focused on terminal cancer patients, but over recent decades has greatly expanded to include any and all non-cancer diagnoses. This would include end of life care for terminal cardiac, pulmonary, neurologic/ dementia, HIV patients, as well as pediatric patients. This has resulted in slightly more than half of all Medicare beneficiaries dying with at least one day of hospice care (50.7% in 2018)I. The expansion to all potential terminal disease states is balanced by the following hospice access barriers:

inability to provide concurrent care (particularly terminal dialysis and those with hematologic malignancies), as well as continued inequities for under-represented minorities. There are additional barriers for those patients living in rural areas and those who have no health insurance or are under-insured. The current MHB does not allow and/or provide a sustainable financial model to provide concurrent care i.e., the concept of allowing a patient to seek palliative treatments, or even transition off of them, while receiving hospice services. This forces patients to ‘draw a line in the sand’ and choose one discrete clinical pathway or the other. This decision is often difficult and painstaking for both patients and providers, as they navigate a myriad of end of life decisions. This dilemma is particularly common in certain terminally ill patient populations, like End Stage Renal Disease (ESRD) patients receiving dialysis, as well as patients with hematologic malignancies who require frequent blood transfusions. Typically, these patients are not able to enroll in hospice until they ‘agree’ to stop all dialysis treatments and/or transfusions. This often results in no hospice care for these fragile patients, or very short periods of hospice, usually measured in www.acms.org

Perspective Perspective hours to a few days. At UPMC Family Hospice, we have been fortunate to have resources and grant funding to create a novel ‘Expanded Access’ program to address some barriers to concurrent hospice care. This innovative program is able to provide limited dialysis treatments for ESRD patients, as well as radiation and transfusion for cancer patients. Since 2018, we have enrolled nearly 100 patients into this program and this extremely tenuous patient population has benefited from an average hospice length of stay measured in months. Although this small program has been successful, it is but a band-aid in the larger scope of the MHB. Reform is imperative and this notion continues to gain momentum nationally at the policy level. Elements of concurrent care can be found in the Medicare Care Choices Model (MCCM), as well as the inclusion of Hospice in CMMI’s Value Based Insurance Design (VBID,) which started earlier this calendar year. There are additional bills in Congress and the Senate addressing reimbursement models for community based palliative care, which often aligns well with transitions to hospice care. Like nearly all aspects of health care delivery in the United States, hospice care also has gross inequities in regards to access and inclusion of minority populations. Of the 1.5 million Medicare beneficiaries who received hospice care in 2018, only 8.2% were African

American, 6.7% Hispanic, and 1.8% Asian descentII. For comparison, 2019 U.S. Census data reported the following percentages of minorities: 13.4% African American, 18.5% Hispanic and 5.9% AsianIII. These discrepancies are likely multi-factorial and would include barriers related to trust, culture, religion, lack of outreach, bias, racism, geography, and marketing. These are unacceptable and require commitment and policy from providers, payors, advocacy groups, policy makers and ultimately the government/Medicare to improve these persistent and pervasive access issues. Locally at UPMC, through the Palliative Supportive Institute, we recently have implemented a series of community education initiatives at predominantly black churches in the city of Pittsburgh. The goals of these efforts are to build trust and open communication on such topics as palliative care, living wills, and hospice. Work has focused on collaboration with church elders and their congregations, with deliverables including creation of culturally sensitive brochures on these relevant topics. I would be remiss if I did not address the current COVID-19 pandemic and its disturbing effects on magnifying the inequities in healthcare access, as well as the broader societal harms when loved ones die alone in institutional settings. Although stretched and exhausted, hospice and palliative care

providers have been an invaluable resource for supporting the well-being of providers and residents in the communities they serve during this pandemic. I am confident and optimistic that this resilient group will provide the backbone and fulcrum necessary to continue to further catapult palliative and hospice care into the consciousness of all providers, payors and policy makers. In summary, the increased utilization of the Medicare Hospice Benefit in recent years is quite encouraging. I remain hopeful that innovation, reform, as well as sincere focus on inclusion and access will continue to keep hospice care not only relevant, but equitable in a delivery system that continues to ‘trip over itself’ in this regard. Ultimately, ALL patients in the United States could and should have the ability to die comfortably with an appropriate amount of inter-disciplinary model of hospice care.

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Dr. Lagnese is chief medical officer at Family Hospice. He can be reached at lagnesekr@upmc.edu. i NHPCO Facts and Figures 2020 Edition ii NHPCO Facts and Figures 2020 Edition iii U.S. Census Bureau 2019

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.

Professional announcement advertisements are Professional announcement advertisements available to ACMS members atmembers our lowest prices. are available to ACMS For more information, call 412-321-5030. at our lowest prices.

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Dear Health Care Provider, Thank you for being a trusted partner of both the Pennsylvania Department of Health (DOH) and the Department of Human Services (DHS). We have immense gratitude for health care providers across the state who have worked to educate and vaccinate as many patients as possible. We have fully protected more than 70% of our state’s population from COVID-19, leading Pennsylvania to be one of the top states for vaccinations. However, millions of Pennsylvanians, both adults and children, are still not protected by these lifesaving vaccines. It is essential that we get more people vaccinated and ultimately protected. The last few miles of our journey to vaccinate as many people as quickly and equitably as possible will likely look different. We are asking for your help as a trusted source of health advice, counsel, and care as we go forward. To continue our efforts we are asking you help SEEK, ASK, VACCINATE, and EMPOWER (SAVE) your patients or customers. SEEK: Seek your patients’ COVID-19 vaccination status. ASK/EDUCATE: If your patient isn't vaccinated, ask them about the vaccine and offer education if they’re unsure. To help, order free materials to educate your patients about COVID-19 from PA Unites Against COVID-19 here: https://www.pa.gov/covid/covid-resources-order-form/. VACCINATE: If your patient agrees to vaccination, provide them with a COVID-19 vaccine or a referral to a location that provides COVID-19 vaccination: https://www.vaccines.gov/search/ EMPOWER: Empower your patients to share their vaccination status with the community. PA DOH and DHS are committed to working with our provider partners to combat the continued COVID-19 pandemic, and have identified the following z-code for vaccine counseling that does not result in a vaccination: Z28.20 – Immunization not carried out because of patient decision for unspecified reason This new code will allow us to follow vaccine counseling visits, and take more steps to vaccinate Pennsylvanians. Thank you for your ongoing collaboration. Together, we can stop the spread. Sincerely,

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For classified advertising information, including special member rates, email acms@acms.org or call (412) 321-5030.

Allegheny County Medical Society announces search for Executive Director A Search Committee of Board of Directors for the Allegheny County Medical Society is working with Nonprofit Talent to recruit an Executive Director who will lead the organization through an exciting chapter of growth as the organization recalibrates its services, membership model, and strategic focus areas to meet the evolving needs of the

regional healthcare ecosystem. The position announcement is available at the Nonprofit Talent website https://jobs.nonprofittalent.com/ . Specific questions related to the position may be emailed to Michelle Pagano Heck, President, at Michelle@NonprofitTalent.com. The candidate will be energized by a passionate and committed Board of Directors, and will be experienced in board governance, facilitation, and consensus building. An experienced

nonprofit leader, the ED will model active listening in their approach to building a collaborative, high performing work culture rooted in trust and a collective pride in the rich history of the organization. According to Dr. Peter Ellis, Chair of the Search Committee, “We are excited to identify our next leader who will embrace and build upon the organization’s legacy of successful membership, advocacy and grantmaking.”

2022 Bulletin Photo Contest Winners Congratulations to Malcolm Berger, MD, whose photo, “A River Lightening,” was the first-place winner of the 2021 ACMS Bulletin Photo Contest. His photo will appear on the January 2022 cover of the Bulletin. Additional winners include: David Sacco, MD, – “Lake McDonald Glacier Park” Nina Verghis, MD – “Sunset” and “Waterfall” Alexanndra Kreps, MD – “Tranquility, Cooks Forest, PA” Mark E. Thompson, MD – “Shenandoah Sunset” Elias Y. Hilal, MD – “Ohiopyle” and “City of Bridges” Mark Thompson, MD – “Lenhart” Robert C. Cicco, MD – “Tower of Voices at Flight 93 Memorial” Terence W. Starz, MD – “Perfection” and “Pittsburgh Sunrise” These photos also will appear on 2022 Bulletin covers. Congratulations to all winners and thank you to all who participated in the 2021 ACMS Bulletin Photo Contest!

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Alliance News Perspective You’re Invited! Allegheny County Medical Society Alliance Holiday Party and Dinner December 9 The Allegheny County Medical Society Alliance cordially invites you to its Holiday Party and Dinner on Thursday, December 9th, at the South Hills Country Club at 6 pm. Musical entertainment will be provided by vocalist Jerry DeMaria, who will perform a musical tribute to the stars. Guests are encouraged to donate socks for Operation Safety Net. If you are unable to attend, donations are welcomed. Menu will consist of English Style Cod ($45) or Chicken Piccata ($40). Guests are welcome to attend. Valet parking will be available. For reservations, contact chairwomen Patty Barnett or Barbara Wible at (412) 422-2340.

Holiday party planning. ACMSA members Susan Leehan, Tina Purpura, and Patty Barnett (left to right) meet to plan for the Alliance Holiday Party and Dinner.

Society News Perspective 30th Annual Virtual Clinical Update in Geriatric Medicine set for March 31 - April 1, 2022 The 30th Annual Clinical Update in Geriatric Medicine Conference will take place on March 31 through April 1, 2022. After careful consideration by the Course Directors and Board of Directors and reviewing the positive responses from the inaugural virtual conference in April, the decision was made to offer a virtual experience for 2022. We are excited to build on the success of the last conference by adding enhancements for an exceptional experience. Course directors Shuja Hassan, MD, Neil Resnick, MD, and Lyn Weinberg, MD, along with the Planning Committee members, have started initial planning.

The team is committed to creating a superb program which delivers practical, as well as an evidence-based information approach and to identifying nationally recognized speakers who can share their expertise in a succinct and entertaining way that facilitates its incorporation into practice. This well-respected American Geriatrics Society (AGS) award-winning course is jointly provided by the Pennsylvania Geriatrics Society - Western Division (PAGS-WD), UPMC/University of Pittsburgh Institute on Aging,

UPMC/University of Pittsburgh Aging Institute and University of Pittsburgh School of Medicine Center for Continuing Education in the Health Sciences. Conference credits include AMA PRA Category 1 creditsTM, AAFP, Nursing, Risk and ACPE credits. Members of the PAGS-WD receive a discount when registering. We look forward to providing another engaging and robust virtual experience and appreciate your patience as we continue planning. Visit https://dom.pitt.edu/ugm/ periodically for details on the course.

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Society News Perspective Pittsburgh Ophthalmology Society announces upcoming monthly meetings The remaining guest faculty are set for the upcoming December, January, and February (2022) monthly Pittsburgh Ophthalmology (POS) meetings. All meetings take place at the Rivers Casino, centrally located on the North Side, with free parking. Valet parking is also available for a small fee. The ballroom, located on the second level, is a non-smoking facility and provides ample social distancing space. The facility adheres to strict food and beverage serving guidelines and follows all CDC protocols. The Society’s top priority is the health and safety of all participants. We will continue to monitor regulations and recommended guidelines set forth by the Centers for Disease Control Prevention (CDC) and notify members should a change in the meeting be deemed necessary On December 2, the POS welcomes Edwin H. Ryan, MD, Vitreoretinal Surgery, PLLC, Associate Clinical Professor Ophthalmology, University of Minnesota Department of Dr. Ryan Ophthalmology, Edina, MN. Thank you to Thierry Verstraeten, MD, for inviting Dr. Ryan and to Regeneron for sponsoring the meeting. Dr. Ryan received his Doctor of

Medicine degree from the University of Minnesota. He completed a residency in Ophthalmology at Northwestern University and a fellowship in Diseases and Surgery of the Retina and Vitreous at Washington University in St. Louis. He directed the Retina Service at the University of Minnesota Department of Ophthalmology from 1989 to 1992 and is currently an Associate Clinical Professor of Ophthalmology. To begin the new year, the POS will reconvene on January 6 and looks forward to welcoming Gregory S.H. Ogawa, MD, an ophthalmologist with Eye Associates of New Mexico, Albuquerque, Dr. Ogawa NM. Dr. Ogawa specializing in problems involving intraocular lenses, irises, cataracts, and corneas. He manages complex patient cases, often for the underserved, routinely treating monocular patients and infants and children with cataracts as well as performing ocular reconstructive procedures for eyes that have experienced a range of injuries. At Eye Associates of New Mexico, he serves as the medical administrative officer in addition to his patient care activities. Dr. Ogawa has designed multiple surgical instruments with the goal of making eye surgery safer and more effective. He has also developed, presented, and published new surgical

techniques in the area of iris reconstruction and suture fixation of intraocular lens implants. He helped advance and disseminate new surgeries such as endothelial keratoplasty—implantation of miniature telescopes for patients with macular degeneration—and soon, the implantation of custom artificial irises. Thank you to Zachary Koretz, MD, for inviting Dr. Ogawa David A. Crandall, MD, rounds out our 2021-2022 speaker series and will join POS members on February 3, 2022. Dr. Crandall is a staff ophthalmologist with Henry Ford Eye Care Services Dr. Crandall Department of Ophthalmology, Henry Ford Hospital, Detroit MI. Dr. Crandall is a graduate of University of Michigan in Ann Arbor and the Creighton University School of Medicine in Omaha, Nebraska. Thank you to Ian Conner, MD, PhD, for inviting Dr. Crandall and to Aerie Pharmaceuticals for support of the program. Registration is handled on-line only. Please visit the POS website periodically for updates and to register, www.pghoph.org. Contact Nadine Popovich, administrator, to confirm the status of your membership or to inquire about upcoming programs. She can be reached by email: npopovich@acms.org or by phone: (412) 321-5030.

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Materia Medica Perspective

Semglee® (Insulin Glargine) WILLIAM BEATHARD, PHARMD AND SAMANTHA DEMARCO, PHARMD, BCPS ackground: Semglee® (insulin glargine) 100 units/mL is a long-acting recombinant human insulin analog recently FDA approved for the treatment of Type 1 and Type 2 diabetes mellitus, June 11, 2020.1,2 Semglee®, similar to Basaglar FDA approved in 2014, is a biosimilar of insulin glargine that established appropriate physiochemical, pharmacodynamic, and pharmacokinetic bioequivalence with insulin glargine 100 U/mL.2 Clinical trials have demonstrated this once daily insulin glargine biosimilar exhibits noninferiority to insulin glargine with respect to long-term HbA1c reduction. This insulin analog was designed with market competition and cost mitigation in mind. Safety: As with other long-acting insulins, Semglee® is contraindicated during episodes of hypoglycemia.1 In 24 and 52-week clinical trials, non-severe treatment-related hypoglycemia was the most common adverse event however the incidence was comparable to insulin glargine with respect to both anytime and nocturnal hypoglycemia.3,4 Tolerability: Semglee® is approved for subcutaneous administration once daily at any time of the day, administered at the same time every day an reflects the tolerability of other FDA approved insulin glargine analogs.1 It carries a similar adverse

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effect profile as demonstrated in other insulin glargine trials. Aside from hypoglycemia, adverse effects occurring in > 10% of patients include upper respiratory tract infections, nasopharyngitis, peripheral edema, hypertension, influenza, sinusitis, and bronchitis.1,3,4 At a mean dose of 0.37 units/kg and ~0.3 units/kg in the 24 and 52-week studies respectively, the prevalence of adverse events was similar between groups.3,4 Weight gain and lipodystrophy are still shared among all insulin and insulin analogs.1 Treatment related discontinuation rates between Semglee® and insulin glargine were comparably low in both studies at 1.1%.3,4 Efficacy: In clinical trials, Semglee® has been shown to be non-inferior to reference insulin glargine with respect to mean change in HbA1c from baseline.1,3,4 Outcomes in HbA1c reduction in type 2 diabetics receiving oral antidiabetic agents were studied in the INSTRIDE 2 study, a 24-week, multicenter, open-label, randomized, parallel-group, phase III non-inferiority study.4 560 patients were randomized to receive Semglee® or insulin glargine at a predefined recommended starting dose of 10 units or 0.2 units/kg. The results of this trial demonstrated a mean change in HbA1c of -0.60% from baseline to week 24 compared to -0.66% seen with insulin glargine (mean in-between

group difference 0.06%; 95% CI -0.10, 0.22). Mean HbA1c was also the primary endpoint in the INSTRIDE 1 study, a 52-week, open-label, randomized, phase III study in type 1 diabetics.3 558 patients were randomized to receive either Semglee® or insulin glargine in combination with three times daily meantime insulin lispro. The results of this study revealed a mean change in HbA1c from baseline to week 24 of 0.14% in the Semglee® group and 0.11% in the insulin glargine group (mean in-between group difference -0.05%; SE 0.052, 95% CI -0.148, 0.057). Secondary clinical endpoints in both studies included changes in insulin dose, fasting plasma glucose (FBG), and self-monitored blood glucose (SMBG).3,4 The INSTRIDE 2 trial, a non-inferiority study, noted no significant differences in the mean FBG between the Semglee group versus the insulin group (-0.74mmol/L vs -1.05mmol/L, p = 0.071).4 Significant decreases in SMBG were observed similarly in both treatment groups, and the mean daily insulin dose significantly increased over the 24-week study period to 0.37 units/kg and 0.38 units/kg in the Semglee® and insulin glargine group respectively. The INSTRIDE 1 trial demonstrated similar results at the end of the 52-week study period with no

Materia Medica Perspective significant between group differences shown in changes in FBG and SMBG with an increase in daily basal insulin dose of 0.0128 units/kg in the Semglee® group and 0.0043 units/kg in the insulin group.3 Both studies demonstrated slight increases in mean weight from baseline to week 24 and 52.3,4 Price: The manufacturer price for the 10 mL multiple-dose vial (100 units/mL) is estimated at $98.65 vial. The estimated price for a box of five 3 mL prefilled pens (300 units) is $147.98.5 Weight based dosing precludes accurate estimated monthly pricing based off mean dose of daily insulin evaluated in clinical trials. Mylan offers both copay programs and a patient assistance program to support affordability, touting up to $75 off monthly prescriptions. Simplicity: Semglee® will be supplied as a 10 mL multiple-dose vial (100 units/mL), 3 mL prefilled pens (300 units) in 3 and 5 pen package sizes, and is compatible with BD Ultra-Fine needles.1 Dosing should be initiated at 0.2 united/kg or up to 10 units/day in insulin naïve patients with type 2 diabetes. In patients with type 1 diabetes, initial dosing of Semglee® is recommended at an estimated one-third of the total daily insulin requirements. Recommended dose conversion between once-daily Semglee® to other once-daily insulin glargine products (300 units/mL) is 80% of the discontinued dose. Bottom Line: Clinical trials have demonstrated the noninferiority of Semglee® to insulin glargine with respect to mean change in HbA1c. Drug induced adverse event profiles, safety, and tolerability were also comparable. The recent FDA approval of Semglee® provides an effective and affordable solution to patients who require long acting insulin. This price window allows the biosimilar Semglee® to carve out a niche in type 1 and type 2 diabetics with consistent daily insulin requirements at a fraction of the cost. Statement: At the time of authorship, William A Beathard is a PGY-1 Pharmacy Resident at UPMC St. Margaret and can be reached at beathardwa@upmc.edu. Samantha DeMarco is a PGY-2 Geriatric Pharmacy Resident and can be reached at demarcosl@upmc.edu. Heather Sakely, PharmD, BCPS, BCGP provided editing and mentoring for this article and can be reached at sakelyh@upmc.edu.

ACMS Bulletin / November 2021

REFERENCES

1.Mylan Specialty L.P. SEMGLEE™ (insulin glargine injection) [package insert]. U.S. Food and Drug Administration website. https://ww w.accessdata.fda.gov/drugsatfda_docs/label/2020/210605s000lbl.pd f. Accessed October 10, 2020. 2. Hoy SM. MYL1501D Insulin Glargine: A Review in Diabetes Mellitus. BioDrugs. 2020 Apr;34(2):245-251. doi: 10.1007/s40259020-00418-x. Erratum in: BioDrugs. 2020 Aug;34(4):541. PMID: 32215829; PMCID: PMC7217807. 3. Blevins TC, Barve A, Sun B, Ankersen M. Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52 weeks: Results of the INSTRIDE 1 phase III study. Diabetes Obes Metab. 2018 Aug;20(8):1944-1950. doi: 10.1111/dom.13322. Epub 2018 May 7. PMID: 29656504. 4.Blevins TC, Barve A, Sun B, Raiter Y, Aubonnet P, Muniz R, Athalye S, Ankersen M. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study. Diabetes Obes Metab. 2019 Jan;21(1):129-135. doi: 10.1111/dom.13495. Epub 2018 Sep 4. PMID: 30112792.

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Legal Report Perspective

Anatomy of a False Claims Act Suit: U.S. ex. rel. D’Cunha v. Luketich et al. BETH ANNE JACKSON ith the filing of case referenced in the title (“Luketich”) on September 2, 2021, Dr. James D. Luketich, the University of Pittsburgh Medical Center (UPMC) and University of Pittsburgh Physicians (UPP) began a long journey to defend themselves against allegations that they violated the False Claims Act (FCA) by submitting claims to various government programs, including Medicare, based on false statements. The purportedly false statements underlying the suit are Dr. Luketich’s statements in operative reports that he was present for the entirety of, or for key or critical portions of, surgeries while he was allegedly participating in three concurrent surgeries. Claims for hospital services and the physician’s services were subsequently filed by UPMC and UPP, respectively. The purpose of this article is not to criticize or defend the parties to the lawsuit. Rather, it is to explain how an FCA suit comes about. Qui tam FCA suit. This lawsuit began with the disclosure of information to the government under seal by Dr. Jonathan D’Cunha, a cardiothoracic surgeon who had worked at UPMC for UPP from 2012 to 2019. Federal law allows parties

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known as relators to file suit for violations of the FCA on behalf of the United States. However, the relator must be an “original source.” There are two ways that a person may be considered an original source. The first way is for a relator to disclose information that forms the basis for a complaint to the government before the information is publicly disclosed. The second way is for the relator to disclose to the government independent knowledge that materially adds to information already publicly disclosed before filing a qui tam lawsuit. Once the information is disclosed, the United States Attorney is given an opportunity to intervene in the suit and prosecute it, decline to prosecute it or seek its dismissal. If the lawsuit proceeds and is successful, whether at trial or in settlement negotiations, the relator is entitled to a portion of the proceeds that varies based on whether the government has intervened. The maximum percentage is 30% if the government has not intervened. Basis for FCA. All FCA suits are based on allegations that a person or entity has knowingly made, or caused to be made, a false or fraudulent claim for payment from the United States. In

the health care arena, this commonly arises when a claim is submitted for services not provided – that is, when fraud is committed. FCA/qui tam cases can also be based on an “implied certification” theory. The implied certification theory means that when a provider submitted a claim, it implicitly represented that it complied with relevant Medicare program requirements relating to the services that comprise that claim. Accordingly, if services are provided in violation of statutes or regulations (for example, when the parties have violated the anti-kickback statute), or when a provider has not met the standards or conditions of payment for the services that it bills, and a claim is submitted regardless, the FCA is violated. The falsity of the claim must be material, such that it would influence whether or not the governmental program would pay the claim. In addition, the party submitting the claim must have actual knowledge of the falsity or act with reckless disregard regarding, or deliberate ignorance of, the falsity. Theory of Luketich. The Luketich case relies on an implied certification theory and allegedly false statements that underly the claims submitted for both physician and hospital services.

www.acms.org

Legal Report Perspective The complaint alleges that the services rendered by Dr. Luketich did not meet the standards for surgeons at teaching hospitals and that the hospital services also did not meet applicable regulatory standards for a teaching hospital. With respect to the former, those standards state that if a physician is participating in three or more concurrent surgeries, then the services rendered are not billable services rendered to individual patients, but rather supervisory services to residents. With respect to the hospital services, the complaint alleges that UPMC knowingly permitted Dr. Luketich to operate in three concurrent surgeries in violation of regulations regarding teaching hospitals, allowing both the hospital and UPP to submit inflated claims for anesthesia. The complaint further alleges that the parties failed to obtain patients’ fully informed consent regarding the concurrent surgery

practices, which would also violate federal regulations. Import. All providers, not just hospitals, are potentially subject to qui tam FCA suits when employees, or former employees, raise compliance concerns and are ignored. The proper response to an employee complaint of non-compliance is first to investigate the matter and determine whether there was an actual violation. If a violation occurred, then the provider must determine whether amounts received for non-compliant services must be repaid. Amounts that must be repaid are called “overpayments,” which must be repaid within 60 days of identifying and quantifying the amount of overpayments. Failure to refund overpayments in a timely manner is itself a violation of the FCA. A robust compliance plan, together with empowering the compliance

department to hold all persons in the organization responsible for their respective violations, is essential to ensuring compliance and preventing FCA lawsuits. DISCLAIMER: This article is for information purposes only and does not constitute legal advice. You should contact your attorney to obtain advice with respect to your specific issue or problem. Ms. Jackson is a shareholder in the Health Care Practice Group of Brown & Fortunato, P.C., which is headquartered in Amarillo, Texas, and serves healthcare providers nationally. She is licensed in both Pennsylvania and Texas and maintains an office in the greater Pittsburgh area. She may be reached locally at (724) 413-5414 or bjackson@bf-law.com. Her firm’s website is www.bf-law.com.

Thank you for yoour membership in the t Allegheny Couunty Medical Societty The ACMS Membership Com mmittee appreciates your support. Your membership strengthens the society and helps protect our patients. Pl Please make k your medical di l society i t stronger t g by b encouraging gi g your colleagues ll g tto become b mem mbers of the ACMS. For information, call the membership department at (412) 321-5030, ext. 10 09, or email membership@acms.org. ACMS Bulletin / November 2021

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* Case classifications reflect definitions utilized by CDC Morbidity and Mortality Weekly Report. ** These counts do not reflect official case counts, as current year numbers are not yet finalized. Inaccuracies in working case counts may be due to reporting/investigation lag. NOTE: Disease reports may be filed electronically via PA-NEDSS. To register for PA-NEDSS, go to https://www.nedss.state.pa.us/NEDSS. To report outbreaks or diseases reportable within 24 hours, please call the Health Department’s 24-hour telephone line at 412-687-2243. For more complete surveillance information, see ACHD’s 10-year summary of reportable diseases: https://www.alleghenycounty.us/Health-Department/Resources/Data-andReporting/Infectious-Disease-Epidemiology/Epidemiology-Reports-and-Resources.aspx.

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www.acms.org

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Joshua R. Silverstein, MD, FHRS Cardiac Electrophysiologist Location: AHN Cardiovascular Institute Allegheny General Hospital Specialties: Electrophysiology for targeted identiﬁcation and treatment of heart rhythm problems such as arrhythmia. Diagnosis and treatment of heart rhythm problems such as atrial ﬁbrillation, supraventricular tachycardia, ventricular tachycardia, and inherited rhythm disorders. Dr. Silverstein comes to Allegheny Health Network with eight years of experience and is known for taking excellent care of his patients and communicating well with referring providers.

Career Opportunity Perspective Title: Executive Director Organization: Allegheny County Medical Society Location: Pittsburgh, PA The Organization Established in 1865, the Allegheny County Medical Society (ACMS) is a 501(c)6 membership-based organization that serves over 2,000 physicians, medical students, and practice administrators in Allegheny County. Tracing its history back to the Civil War, the organization is celebrated as one of the leading professional associations of physicians in the nation, and is governed by physician members elected to its Board of Directors. ACMS provides advocacy, education, professional development, philanthropic support, and networking opportunities that equip providers with the resources they need to deliver quality patient care, and find joy and fulfillment in the medical profession. Ɣ Ɣ

Mission: Improve healthcare through education, advocacy, service, and physician well-being. Vision: A healthy region with compassionate medical care.

ACMS serves its member physicians and administrators through the following core programs: Ɣ

ACMS Foundation: The 501 (c) 3 philanthropic arm of the organization, the foundation awards grants to support home and community environments that nurture and develop healthy children and families for a healthy Allegheny County. Ɣ Advocacy and Community Engagement: Raising awareness and building coalitions to advance the ƉƌŽĨĞƐƐŝŽŶ͛Ɛ ŝŶƚĞƌĞƐƚƐ ŝŶ ŚĞĂůƚŚ ĐĂƌĞ ůĞŐŝƐůĂƚŝŽŶ͕ ƌĞŐƵůĂƚŝŽŶ͕ ĂŶĚ ƌĞŝŵďƵƌƐĞŵĞŶƚ ƉŽůŝĐǇ͕ ĂŶĚ ŝŶĨŽƌŵŝŶŐ physicians of the legal perspectives and requirements affecting them. Ɣ The Bulletin: Established in 1911, the Bulletin is a monthly, 36-page publication mailed to 2,200 physicians, healthcare administrators, practice managers, and other healthcare executives. Content includes legal, legislative, and practice management updates; opinion pieces; colleague achievements; pharmaceutical information; community events; and resources. Ɣ Administration for Affiliate Societies: The ACMS is contracted to serve as the fiscal conduit and support staff for local specialty physician societies. For more information about the organization, please visit the ACMS website. Position Overview The new Executive Director (ED) of the ACMS will lead the organization through an exciting chapter of growth as the organization recalibrates its services, membership model, and strategic focus areas to meet the evolving needs of the regional healthcare ecosystem. The candidate will be energized by a passionate and committed Board of Directors, and will be experienced in board governance, facilitation, and consensus building. An experienced nonprofit leader, the ED will model active listening in their approach to building a collaborative, high performing work culture rooted in trust and a collective pride in the rich history of the organization. They will ĞŵďƌĂĐĞ ĂŶĚ ďƵŝůĚ ƵƉŽŶ ƚŚĞ ŽƌŐĂŶŝǌĂƚŝŽŶ͛Ɛ ůĞŐĂĐǇ ŽĨ ƐƵĐĐĞƐƐĨƵů membership, advocacy and grantmaking. They will lead the staff to strengthen current external partnerships and build new ones that raise awareness of and increase ĞŶŐĂŐĞŵĞŶƚ ŝŶ ĞǀĞƌǇ ƉŝůůĂƌ ŽĨ ƚŚĞ ^ŽĐŝĞƚǇ͛Ɛ ǁŽƌŬ͘ The successful candidate will value and possess a deep understanding of modern nonprofit financial management and administration best practices, specific to membership organizations. They will identify strategies and resources needed to operationalize strong systems, processes, and data-driven decision making, and will align the board and staff in an implementation plan for these new systems.

Career Opportunity Perspective Managed by a Board of 21 physicians, the Executive Director will oversee a 3 person staff, make recommendations for additional staffing resources, and manage an annual budget of approximately $2 million. The ED will perform the following duties and will work in accordance with the policies and goals established by ACMS and the Board of Directors: Knowledge, Skills, and Abilities The Executive Director will be a strong communicator, active listener, and relationship builder who shares the ďŽĂƌĚ͛Ɛ ĚĞĞƉ ĂƉƉƌĞĐŝĂƚŝŽŶ ĨŽƌ D^͛Ɛ ŵŝƐƐŝŽŶ͘ ůů ĐĂŶĚŝĚĂƚĞƐ ƐŚŽƵůĚ ŚĂǀĞ ĞǆĞĐƵƚŝǀĞ ůĞĂĚĞƌƐŚŝƉ ĞǆƉĞƌŝĞŶĐĞ͖ Ă proven ability to effectively build or work with a nonprofit Board of Directors; as well as exceptional fiscal and relationship management skills. Demonstrable experience, competencies, and qualifications include: Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ Ɣ

Passion for and commitment to the ACMS mission and vision. Previous experience in membership-based organization, trade associations, or chambers of commerce. Educational background aligned with the requirements of the position. Effective listening and consensus-building skills on teams with diverse perspectives and lived experiences. Working style that is transparent, encouraging, and collaborative. Strong change management abilities, and experience making difficult decisions while convening a unified team through periods of growth and transition. Senior level experience in an organization of a comparable budget, staff and program size and complexity. Successful operations management and administration experience. Previous financial management responsibility of an organization (i.e. developing budgets, creating financial reports, reporting financial health to the board) Public speaking and excellent communication skills, both written and verbal, with the ability to serve as a strong external spokesperson for an organization.

Compensation This position offers a competitive salary in the $150,000 - $180,000 range and a traditional benefits package found with other nonprofit organizations of similar size, scope, and scale. DEI Imperative ACMS seeks to recruit candidates for employment that represent our diverse community in race, gender, religion, sexual orientation, and ability. Inclusive and equitable in our recruitment and retention practices, we are dedicated to uplifting diverse opinions and backgrounds in order to grow and evolve as a welcoming workplace for all. ACMS is an equal opportunity employer. How to Apply ACMS has retained Nonprofit Talent to assist with this important organizational change process. Specific questions related to the position may be emailed to Michelle Pagano Heck, President, at Michelle@NonprofitTalent.com. Please direct all inquiries related to this position to Nonprofit Talent, and do not contact ACMS. Resume, position specific cover letter, and salary expectations uploaded here: https://nonprofittalent.applytojob.com/apply/WMa8UOSH8a/Executive-Director-Allegheny-County-MedicalSociety APPLICATIONS ARE DUE BY 5PM ON NOVEMBER 29, 2021

&DUH LV <RXU %XVLQHVV LWV &KDQ 1DY DYLJDWLQJ Y QJHV LV 2XUV 2 The healthcare environment e is changing. Physicians P must focus on prooviding the highest quality care c with intense competition forr their time. Medical practicces face increased challenges tied to changes to regulatioon, insurance m protocols, cost-m management and revenue management. Houston Harbaaugh g has over 30 years y of exp p perience in helping p g physicia p y ans and medical practices p m g change manage g w practice startthrough contracct negotiations with hospitaals and payors; contract management; advocacy and new up counsel. Wee have provided critical supp port in practice mergers and acquisitions. And we havee provided sound ues ranging from HIPAA coompliance to medical staff and peer review matters. advocacy on issu

Every challen nge a medical practice can face, we have seen. We have helped praactices of all size and struccture meet me these challeenges. And we know what is ahead. -HVVLLFD $ $ (OOHO (OOHO 'LUHFWRU DQ DQG QG +HDOWKFDUH 3UDFWLFH &KDLU MDHOOHHO#KK ODZ FRP

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ACMS Bulletin, November 2021

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