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PHYSICIAN SPOTLIGHT PAGE 3
C. Michael Jones, MD ON ROUNDS
Memphis Pathologist: Genetics Providing Key Information in Fight Against Cancer By GINGER PORTER
MEMPHIS on the MEND BY PAMELA HARRIS
FORCE: Facing Our Risk of Cancer Empowered Irene Rodda Brings New Support to Those Facing Hereditary Risk of Cancer As a young girl growing up in the Queens Borough of New York City, Irene Rodda remembers visiting the graves of her maternal family .... 6
In Case of Emergency Tennessee Department of Health’s Role in Protecting the Population Between immunizations, primary care services, licensure and regulation of health facilities, analyzing health statistics and launching preventive care initiatives, it’s easy to think of the Tennessee Department of Health as more ‘Clark Kent’ than ‘Superman.’ ... 11
At one time, a lab-examined resection of tissue on a slide would report only malignancy and cancer stage. Now, thanks to genetic advances, the analysis can give clues to the cancer’s own destruction, according to Kenneth Groshart, MD, a pathologist at Trumbull Laboratories, LLC. Since the full sequence of the human genome was completed and published in April, 2003, an explosion of applications to all varieties of tumors has emerged. “The forefront of cancer diagnosis and therapy is in the realm of molecular genetics to find out what makes cancer cells different from normal cells,” Groshart said. “Our primary job is to identify all the different cancer types and try to get to know which have usable molecular tests and can be addressed with targetable agents.” The tumor panels Trumbull selects are from nationally recognized molecular genetic laboratories. (CONTINUED ON PAGE 16)
Walter Rayford, PhD, MD, MBA President, Bluff City Medical Society; President, R. Frank Jones Urological Society, National Medical Association By JUDy OTTO
Building a better communication platform beats a better mousetrap by a mile, and the Urology Center’s Walter Rayford, PhD, MD, MBA, knows it. If his current project succeeds, the world won’t have to beat a path to his door. They’ll arrive electronically. Rayford’s early interest in computer sci-
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ence started him on a career path that has led to his platform-building plans – one of his top initiatives today. Beginning with his bachelor’s degree in biology from Jackson State University and a PhD in biochemistry from the University of Kansas, Rayford was prompted by his father’s illness to pursue the kind of doctoral degree that would allow him to use his knowl-
(CONTINUED ON PAGE 10)
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C. Michael Jones, MD
He’s Made Change the Order of the Day at The Jones Clinic By RON COBB
The interview with C. Michael Jones, MD, was set for 11 a.m., but as the appointed time came, the doctor was busy elsewhere. So while the reporter waited, David Crislip, new COO at The Jones Clinic, filled in as best he could, trying to find just the right words to describe the clinic’s patient-first attitude toward cancer treatment. Then it occurred to Crislip that Jones’ tardiness was Exhibit A. “That’s why Dr. Jones couldn’t just stop and do this interview,” Crislip said. “He’s with a patient, and apparently that patient needs more.” A few minutes later, Jones arrived to talk about the latest in cancer care and the changes taking place at The Jones Clinic, as well as what the doctor perceives to be its unique advantage of being an independent clinic. He opened the private oncology and hematology clinic in 1997, just two years after coming to Memphis to join another group. Previously, he had been in Houston at the MD Anderson Cancer Center. Now, 16 years after it opened, change is the order of the day at The Jones Clinic’s offices in Germantown and New Albany, Miss. Crislip took over as COO in July. Kristen Lane is on board in a newly created position: physician relations manager. Her duties will include cultivating relationships with area physicians. Another doctor is expected to be added to the clinic’s staff in the coming months. Also, the clinic is working on changes in its logo, website, newsletter and patient packets. Why so many changes now? “I think a lot of this is driven by changes going on in medicine,” Jones said. “I think there is a tendency now, particularly by Medicare, to encourage larger and larger organizations, and we want to make sure we stay focused on the patient and personalized care. So we view it as an opportunity for us to grow in that dimension.” Being an independent, Jones said, allows the clinic to “still give very personalized care and focus on the individual, not necessarily institutional needs.” As for advantages that other clinics might have in being affiliated with a hospital, Jones said, “I think there are some. We just never really had that kind of hospital support.” Jones grew up in Birmingham, Ala., and earned his medical degree at the University of Alabama then did his internship and residency there. He completed his fellowship in medical oncology at Johns memphismedicalnews
Hopkins and then served as a medical officer at the Laboratory of Immunodiagnostics at the National Institutes of Health. Besides an appointment as an associate professor of internal medicine in the department of hematology at MD Anderson, Jones was associate director of the hematology/oncology division at the University of Texas Medical School in Houston. Jones, as well as a cousin who became an endocrinologist, was inspired to pursue a career in medicine by his grandfather.
“He was an actual country doctor,” Jones said. “He really made rounds in a horse and buggy.” One of the incentives for coming to Memphis in 1995 and joining a group was financial. “At that time I had kids who needed to go through college,” he said. “And it was close to home. My mother was still alive at that time and she was living in Birmingham.” Crislip brings a wide variety of experience to the clinic as COO. He started in healthcare as a Navy corpsman at age 17. After a stint at the old St. Joseph Hospital in Memphis, working in supply and another in sales and services, he earned a bachelor’s degree in nursing. For nearly 20 years, he was associated with The MED and then Le Bonheur in roles ranging from director of specialty clinics to director of nursing, chief nursing officer and administrator. “I understand the business side,” Crislip said, “certainly the quality focus. That’s the over-arching thing for everything we do – not just the quality of the care, but the experience here. We want it to be unparalleled. No one with cancer is having a good time. But we want them to feel that they can totally be themselves here, they can be totally relaxed, that all their needs will be met, that we understand the journey they’re taking, and we want to be a positive part of that journey.” In Jones, Crislip said he sees someone who is decisive and willing to lead.
“I found him to be very progressive, very knowledgeable, probably the most knowledgeable leader I’ve worked for. You usually don’t find that in a physician. They’re usually (focused on) the medical practice; he’s much deeper than that.” The changes at The Jones Clinic come at a time when the landscape of healthcare is evolving, not only generally but in cancer. In the bio on his website, it is said that Jones spends a good bit of his spare time reading up on the latest treatments and advances in patient care. So it did not escape his attention when the Wall Street Journal published a recent story on trends in cancer. “There was a very, very good discussion of personalized care,” Jones said. “There are two main things that are happening in cancer. Cancer is no longer going to be necessarily a fatal disease. It will be a chronic disease. It will be treated very much the way we treat, say, high blood pressure and diabetes. No, we may not be able to get them to go away, but we may be able to fix it so you don’t die from your cancer, but you may have to have treatment for the rest of your life. “The other thing that’s going to happen is that the classification of cancers is going to undergo a dramatic change. It’s undergoing that as we speak. The cancer will not be a group of diseases oriented around an organ, but rather everybody is going to have that cancer looked at from a genetic point of view, and cancer is going to become a large group of what really are rare diseases. In other words, you’ve got to be treated based on the genetic findings of your own tumor, not on what it looks like under a microscope.”
ACORN’s Innovations, Strategic Partnerships are Advancing Clinical Oncology Efforts By SERAFINA GINLEY
Edward Stepanski, PhD, is excited about what he is seeing. The chief operating officer at Memphis-based ACORN Research, LLC who has more than 20 years of leadership in academic medical centers is excited about a new endeavor. “It’s something I’ve never seen before,” he said of ACORN’s joint Edward efforts with cancer care Dr. Stepanski institutions. “Right in front of you may be an opportunity to build something, something that for so many reasons never seems to happen. But now, in Memphis, everybody is aligned and pushing in the right direction.” His organization, ACORN is at the forefront of scientific healthcare innovations and flagship research programs in an effort to improve patient care for the nearly 12 million Americans being treated for cancer. Stepanski himself was drawn
to the company’s dynamic research approach and remains passionate about continued innovation. ACORN provides a set of specialized support services to a network of research partners that include local institutions such as The West Clinic, Methodist University Hospital, and the University of Tennessee Health Sciences Center as well as private oncology practices and members of the pharmaceutical and biotechnology industry. ACORN offers clinical trial management, budgetary and regulatory expertise – which may otherwise require additional staff at a research site – in addition to a data warehouse that is constantly evolving to meet the new face of healthcare. Since the inception of the ACORN Network in 2002 by Lee Schwartzberg, MD, and physicians at The West Clinic, the group has worked to develop and perfect IT applications and support systems that aid in clinical research. In 2003, ACORN and Supportive Oncology Services (its sister company) introduced the Patient Assessment, Care and Education System (PACE ™) to more efficiently cap-
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ture its programs’ patient-reported outcomes (PROs). In addition to receiving PROs, the PACE system used an e/Tablet to view patient information and connect to the Cancer Support Network, a provider of educational resources that enhances the time spent between doctor and patient. “This is a vision (that Schwartzberg and The West Clinic) had way back (in 2003) that is only now being embraced by the larger community,” Stepanski said. “Besides pulling information from the patient, it pushed education back in their direction in the form of videos and text documents. (The company saw) the importance of patient engagement in overall care.” The PACE system was recently redeveloped to be supported by any web-based device so the patient may access information and be monitored between visits. Access to ACORN’s data warehouse, which includes the PACE system, drives the company’s approach to Health Outcomes and PharmacoEconomics (HOPE) and allows their experts to conduct studies in patient survey research relevant to treatment development and patient care. Where early phase clinical trials may be very specific in their results, the ACORN HOPE Unit examines data collected as a whole to determine real-world healthcare costs and the effectiveness of clinical research. “The HOPE Unit looks at, for example, how treatments are being sequenced ... which may not be done in a clinical trial,” Stepanski said. Without sponsorship, HOPE can pull results from a variety of trials and research sites to determine what treatments are better serving and at the lowest cost to patients and providers. ACORN’s proactive research work led to the creation of the company’s Contract Research Organization (CRO). Stepanski revealed that ACORN didn’t
necessarily have the goal of developing a CRO. It was the logical next step when industry representatives requested partnerships with ACORN because their models produce more timeline efficient results than other CROs. “ACORN, over the years, supported a lot of investigator-initiated, not industry-sponsored, studies,” Stepanski said. “Some practitioners have a lot of insight into unmet needs, but not the time or maybe the team to create a (trial) protocol. We take that insight and turn it into a fully flushed-out model.” With most of the expertise already on staff at ACORN, forming a CRO was most cost effective. In addition, the new partnerships meant access to a broader range of newly developed drug treatments. Most recently, ACORN developed a strategic collaboration with Clarient Inc., a GE Healthcare company. The partnership centers on molecular testing of tumor samples and developing a workflow of markers so that physicians can plan the most effective treatment for a patient. This type of research is leading the way in precision oncology, where doctors’ treatments are aimed at a patient’s specific tumor. Driving these advancements are ACORN’s 82 employees, all but four of whom are in Memphis. Together, with their network, they bring the latest drug developments and technology to Memphis and 29 satellite locations across eight states. “This is an exciting time in oncology,” Stepanski said. “As someone who has worked in other fields, I feel oncology has the best science, and that (science) is being exported into other fields. If research is going to be done correctly, we need to build new tools – tools that maybe were not needed 10 years ago – but will improve and evolve cancer treatment.”
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FORCE: Facing Our Risk of Cancer Empowered
Irene Rodda Brings New Support to Those Facing Hereditary Risk of Cancer MEMPHIS on the MEND BY PAMELA HARRIS
As a young girl growing up in the Queens Borough of New York City, Irene Rodda remembers visiting the graves of her maternal family. “It was depressing,” she recalls. “They all died before the age of 40.” That stuck with Rodda. She just knew cancer would take her life as it had her relatives. Then, in 1998, another untimely death hit home. Literally. Rodda’s father was diagnosed with leukemia, and nine months later he died. Rodda thought her fate was sealed. But it wasn’t until her mother was diagnosed with early (stage zero) breast cancer in 2008 that Rodda decided to become pro-active with this black cloud that seemed to be hanging over her family. She opted to get tested for the BRCA gene, a human gene in a class known as
tumor suppressors. The BRCA gene was named by the scientist who discovered it, Mary Claire King, PhD. King named it for French pathologist, Paul Broca, who is noted to be one of the first to recognize breast cancer pedigrees as early as 1866.
See it in Film
Decoding Annie Parker, premiering this fall, is based on the true story of a woman similar to Rodda and parallels the life of scientist Dr. Mary Claire King, depicting her struggles as she discovers the BRCA gene.
On To Memphis
Irene Rodda and her family
Rodda tested positive for the BRCA II gene mutation. So for the next several years, with the knowledge that she had an 84 percent chance of developing breast cancer, she underwent frequent diagnostic mammograms, each time experiencing panic and anxiety as she waited for the test results. She eventually found a support group via the Boston Chapter of Facing Our Risk of Cancer Em-
powered, or FORCE. In October, 2012, Rodda attended the FORCE annual conference which she said was both informative and empowering. She was inspired by the women she met; some who had opted for mastectomies and others who had not. This was an experience that helped her weigh her own options. Shortly after the conference, Rodda,
her husband and their four-yearold son moved to Memphis for her husband’s new job at Phillips Lighting. Upon discovering that there was no FORCE chapter in Memphis, Rodda decided to start one. In addition, she made the life-changing decision to have a double mastectomy. In January of 2013, well-known breast specialist, Christine Mroz, MD, performed Rodda’s mastectomy. It’s been a long recovery period for Rodda, who underwent a slight set-back last Mother’s Day with emergency surgery due to a complication with the reconstruction process. Rodda says that the choice she made is not for everyone. “Connecting with FORCE does not mean that you’re going to be pushed toward a mastectomy. Surgery is not the best option for everybody. It’s an individual decision.” Today, Rodda is planning for the future and is much more relaxed in her post-mastectomy world. Her breast cancer risk has dropped from 84 percent to less (CONTINUED ON PAGE 14)
by Bill Appling
Listening and Remaking American Society Are we listening? The volatility and vociferousness of American politics that we are currently experiencing will only end when the country finds a way to resolve its disagreements over vision and values, abandons some of the patchwork, hybrid solutions currently adopted, and comes to an agreement on a new way to organize its public and private sectors. The heart of this consensus will be found in the beliefs and attitudes of the Millennial Generation, whose numbers and unity will provide the foundation for the nation’s new civic ethos. (Millennial Momentum, How a New Generation is Remaking America, Morley Winograd and Michael D. Hais, 2011) • Traditionalists – Born prior to 1941 • Boomers - 1942 to 1960 • Generation X – 1961 to 1981 • Millennial – Born after 1982 The reason you see the year 2011 in bold is because it’s the year Millennial Momentum was published. This is a good time to point out that in 2008, of the approximately 95 million millennials living, 41 percent were of voting age and composed less than 20 percent of the electorate that year. In the 2012 election, about six in 10 millennials were eligible to vote, and about 1 in 4 American voters came from the Millennial Generation. By 2020, when virtually all members of this generation will be of voting age, Millennials will represent more than one out of every three adults (36 percent.) You can see that the numbers of Millennials, which are group oriented “civic generation,” emerges to change the course of history and remake America. As a boomer who is the uncle of three Millennials, all in college, I am finally at a point in life to stop and smell the roses; in other words, be quiet and listen. There are other aunts, uncles and grandparents in the picture who influence the young ones by what they say. Traditionalists and Boomers pay attention to Millennials and have a better chance to make us look at things a little more differently. Just look around. Can you recall the last time you have seen more social change? As discussed in Millennial Momentum, “They will transform other areas of American culture-from education to entertainment, from workplace to home, and from business to politics. Ethnically diverse, socially tolerant, and technology fluent Millennials will ultimately decide the role of the United States regarding our leadership and where we stand in the world community and global marketplace. This generation’s unique blend of civic idealism and savvy pragmatism will enable us to overcome the internal culture wars and institutional malaise currently plaguing the country.” (And I agree.) Any group of this size will be able not only to sway elections and determine public policy in such areas as healthcare, education, energy, and environment, but also to change the way America lives and works. As a boomer with my Millennial niece and nephews, I am optimistic and pumped up. Millennials think most boomers are cool. They are interested in hearing about memphismedicalnews
our civic ethos during the 60s and 70s. Most Millennials will tell you if they had been around during Woodstock they would have been right in the middle of it. Psychologist Constance Patterson, PhD, has written about generational differences at work. Patterson says, “Generational differences sometimes may cause clashes in the workplace, especially among workers on teams. For example, boomers may believe Gen Xers are too impatient and willing to throw out the tried-andtrue strategies, while Gen Xers may view Boomers as always trying to say the right thing to the right person and being inflexible to change. Traditionalists may view Baby Boomers as self-absorbed and prone to sharing too much information, and Baby Boomers may view traditionalists as dictorial and rigid. And Gen Xers may consider Millennials too spoiled and selfabsorbed, while Millennials may view Gen Xers as too cynical and negative.” Patterson encourages members of teams to seek a balance between building on traditional procedures and supporting flexibility and creativity to effectively blend generations’ work ethic. Patterson goes on to say, “For example, effective messages from team members for traditionalists may be, ‘your experience is respected,’ or ‘it is valuable to hear what has worked in the past as well as what hasn’t worked.’ Baby Boomers may need to hear such messages as, ‘you are valuable, worthy,’ or ‘your contribution is unique and important to our success.’ (I have heard many times my contributions tend to be unique, but with my loss of hearing I can’t often make out what the next few words that were said.) Meanwhile, Gen Xers may need to hear messages like ‘lets explore some options outside of the box’ or ‘your technical expertise is a big asset.’ Whereas millennials may seek similar messages to, ‘you will be collaborating with bright, creative people,’ or “you have really rescued this situation with your commitment.’” After all, each generation brings a unique perspective to work-related tasks. Patterson goes on to say, “If we don’t talk about why we’re different and our different perspectives, we don’t come to the best decisions. The more people are willing to invest in honest communication about the issue, the better the outcome. As a side note, I really appreciated the phone calls and emails asking how my dogs were doing after my house was broken into recently. As you may have heard, the thieves beat up one of my dogs, however, both of them are doing well. Channel 24 did a story about the new type of thieves who hurt animals during break-ins. The video went viral and hopefully many animal lovers were informed. Bill Appling, FACMPE, ACHE is founder and president of J William Appling and Associates. He serves on the Medical Group Management board of directors. He is a national speaker, presenter and a published author. He serves as an adjunct professor at the University of Memphis and Chair of Harrah’s Hope Lodge board, and serves on the board of Life Blood. For more information contact Bill at email@example.com.
Pancreatic cancer: new treatment options, finally. Medical oncologists treating patients with pancreatic cancer have long been accustomed to a lack of good treatment options and a dearth of progress in this dismal and rapidly fatal malignancy. Over the years, medical journals have been littered with conducted clinical trial publications reporting negative outcomes, unsuccessful to move the needle in favor of patients’ battling the disease. The picture is slowly beginning to change it seems, though still grim. After a series of clinical trials that failed to improve the survival of metastatic pancreatic cancer patients, the drought ended when Dr. Conroy presenting French-led research during ASCO 2010. At the time, the results were hailed as the best- ever survival data in metastatic pancreatic cancer. The trial compared administration of FOLFIRINOX, a regimen consisting of several chemotherapy drugs, with then-standard gemcitabine arm. FOLFIRINOX improved survival as 48 percent and 18 percent of patients remained alive after one year and 18 months, respectively compared to 20 percent and six percent treated with gemcitabine only. The median overall survival was 11 months for FOLFIRINOX arm compared to 6.8 for gemcitabine arm. The initial rush of enthusiasm waned, however, when FOLFIRINOX was put to use in everyday practice. It became obvious that toxicities, side effects and complexity of this regimen would be beneficial to a minority of patients in good performance status and able to sustain the rigors of multiple courses of chemotherapy. For majority of patients experiencing rapid progression of cancer and ensuing debility, FOLFIRINOX was too toxic. The silver lining for use came in view of regimen’s ability to render a significant shrinkage of the tumor, a valuable response for patients diagnosed with borderline resectable stage. In these patients, chemotherapy induced a reduction in tumor size allowing surgeons to operate on patients previously deemed unresectable due to involvement of nearby structures and blood vessels. The FOLFIRINOX combined response rate was a remarkable 70 percent, which was 20 percent higher than gemcitabine. This made FOLFIRINOX a go-to regimen which in small studies enabled 40 percent conversion to resectable stage, allowing patients to undergo potentially life-saving surgery. Prior to FOLFIRINOX, gemcitabine was mainstay of standard chemotherapy. The drug had mild toxicities, good tolerance and was ease of use which made it a staple of palliative chemotherapy in this dismal disease. Despite wide use, gemcitabine, in the eyes of many oncologists, never really proved its bona fides as only one out of 16 conducted randomized clinical trials done over the years showed modest improvement in overall survival over the 5-FU, the standard treatment at the time. This qualification remained until earlier this year when results of MPACT trial were presented by Dr. Von Hoff at GI ASCO in January. The study revealed superiority of nab-paclitaxel and gemcitabine combination over gemcitabine alone in terms of median overall survival of 8.5 versus 6.7 months. The combination treatment rendered more benefit at 12 months with 35 percent survival versus 22 percent for gemcitabine. Importantly, the benefit continued to persist the second year after treatment started with doubling of survival at two years from four to nine percent when combination of two drugs used. This regimen proved to be well tolerated as patients who randomized to nab-paclitaxel and gemcitabine arm were able to receive 81 percent of intended doses. These improvements to an untrained eye seem minuscule and perhaps insignificant, but to doctors enured in ravages of pancreatic cancer, they are welcomed and much needed new treatment options in the battle against this difficult-to- treat and rapidly fatal malignancy. — Dr. Aleksandar Jankov BMG/Oncology Family Cancer Center Foundation
4992_Facts_MEM_MedNews_4.875x13 2/8/13 10:48 AM Page 1
Child Life Specialists at St. Jude Tackle the Toughest of Tasks By JONATHAN DEVIN
Source: Hospice Perception Study 2010
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And you thought your job was challenging. Child Life specialists at St. Jude Children’s Research Hospital are publishing research in an area where virtually none exists, while tackling the toughest of topics with children and teens. “From the time a child (patient) walks in the door, we teach them about their diagnosis in an age-appropriate way,” said Shawna Grissom, MS, CCLS, CCIM, director of Child Life at St. Jude. “We explain what blood is, what Shawna cells are. Sometimes Grissom it’s tougher discussions about the journey of life, like ‘do I want to continue treatment’ and ‘what happens if I don’t?’” Sometimes the discussion is ‘what would you like to have at your funeral?’ The Child Life department morphed out of a structured play program at the hospital about 17 years ago. Grissom’s staff of 20 specialists is nationally-certified and has a minimum of a bachelor’s degree in child development or human development. Each carries a case load of upwards of 200 patients, usually in the same age group, who visit the hospital throughout the year for treatment. In one day they work with ten to 20 patients ranging from infants to teenagers. Play is at the heart of self-expression and understanding for the younger children. “Play is the foundation of a lot of what we do,” said Grissom. “We focus about half of our practice on play. That’s where we get children to express themselves, through play.” For example, specialists might manipulate a doll with real or play medical supplies, which is easier than asking patients about their feelings verbally. “I can get them to express themselves through play and a few minutes later they may open up and talk about their treatment or a surgery,” said Grissom. Play is also important to help children socialize, which keeps them from regressing developmentally due to the stress of treatment. “We’re working with children to help them cope with the hospital setting, because a hospital setting is not normal for them,” said Grissom. “We’re trying to help them gain trust and confidence as well as to gain mastery for skills in life.” For example, a child who has a port installed under the skin for chemotherapy needs to know why the port is there and how to get through the discomfort of hav-
ing it accessed. “Children need to learn skills like deep breathing, body relaxation, and guided imagery,” said Grissom. “We can also do sensory simulation. Sometimes it’s as easy as having a movie that they’ve not seen before.” Teenagers have resources for expression like Real Talk sessions in which specialists guide discussions like “why did this happen to me” or what life might be like when you know the benchmarks of adulthood are not in your future. They also have special teens-only rooms and access to artists, videographers, and sound recording engineers who give them an outlet for feelings, journaling, and leaving behind a legacy. “Even as adults we have misconceptions about what is happening, what’s going to happen, or what’s wrong with us,” said Grissom. “We try to give (patients) the right answers and alleviate those fears. If we can give them the right information we find that their fears and stress levels tend to decrease. (The treatment) still might hurt, but how do you get through it successfully?” Over the years Child Life has built up a body of information about exactly how that happens, which they are now publishing. The department’s first research study, published in Aug. 2012, was titled “Intervention helps children with sickle cell disease complete MRI tests without sedation.” In it, 71 sickle cell patients ages five to 12, who participated in a short preparation program prior to having an MRI were found eight times more likely to complete the scan without needing sedation. The study was published in Pediatric Radiology. Typically, MRI patients must be sedated during an MRI and they must stay the night before in the hospital. Child Life’s preparation program, which involves education and assigned tasks during the procedure to help them remember to stay motionless, reduces stress and anxiety for the child and represents cost-savings to the hospital. Child Life has also published an article about its Legacy Bead program in which patients add colored, glass beads to a string, each one representing a piece of their journey from “learning to take medicine,” to “homesickness,” to a “losing my hair,” to the silver bead which means “no more chemo.” The program became so popular that a similar one was created for siblings of patients. Currently there are two Child Life studies underway, one which studies patients’ perspectives on learning their (CONTINUED ON PAGE 14)
Hey Doc, What Do Women Want?
By TIM NICHOLSON
In the 2000 film, “What Women Want,” Mel Gibson plays the part of a sexist guy working in an ad agency. He suffers a sort of semi-electrocution. Instead of killing him, it gives him a super power. He’s suddenly able to hear what women are thinking! As such, he can better connect his marketing messages (and a few other messages – but that’s a different sort of article) to their thoughts. Pretty powerful stuff, huh? The movie is full of marketing lessons – even for us, Doc. After all, we know that women influence many of the healthcare decisions in a family. They typically schedule the appointment for their husbands, they definitely plan out the health services for their children, and they’re also taking care of their aging parents. Among other things, the film reminds us that a consumer’s buying behavior is largely driven by irrational fears, frustrations, hopes and volatile emotions. It’s that way with patients, too. So, how do you address that? You pin. Specifically, you join the popular social media site known as Pinterest and develop community around it. Why? Well, first, because women are there. Here’s a little science for you – 80 percent of Pinterest users are females (mostly adults) and half of them have children. The director of communications for the Ovarian Cancer National Alliance says that, for her, “The tipping point with Pinterest was when I noticed that people were actually pinning images from our [web] site.” Teaching Moment Doc, pinning means that the website user is choosing an image from your page to share with her friends on Pinterest. Think “liking” on Facebook but with pictures. Lots of pictures. She added, “I can see that our community is actually using this and they are finding visuals that they want to share… (we decided that we need to) make sure that we’re part of that conversation.” You should too. They’ve been on Pinterest now for over a year. Still, that’s just a place right? Sort of. It’s also a state of mind. Virtually all advertising appeals to emotion instead of logic because emotions are far more powerful when it comes to influencing behavior. In the film’s climactic scene, the Nike pitch, we saw how specific we have to be in addressing the fears, frustrations, and emotional impulses of the women with whom we hope to connect. But how can we find out what these often hidden emotions and irrational fears are? First, you gain trust. Eighty percent of the women using Pinterest say they trust it. It’s likely that you can become part of that trusted community. But first, you’re going memphismedicalnews
to have to do some pinning. You can start by knowing what’s popular and how it relates to your specialty. The top five subjects on Pinterest revolve around Home, Arts, Style/Fashion, Food, and Inspiration with a strong surge related to Health/Fitness. And there’s a conversation, largely in the form of pinning items that others have curated, inviting others to pin to your board, and following people or brands that pin things that resonate with you. How do these top five subjects relate to health? • Home – Women living with children, aging parents, or disabled family members want to make a safe, livable space without compromising style. They pin. • Arts – What about images that soothe a discomforted soul or a recovering patient? Pin some. • Style/Fashion – Hey, not everything is science here, but I’ve seen pins of maternity fashion or things women might aspire to wear that would help inform some of the healthcare decisions. Find someone pinning those and re-pin them. • Food – Recipes rule on Pinterest. Almost any medical condition can be affected in a positive way through a healthy diet. Do you know the foods that might whet the appetite of your patient and help her to achieve a healthy lifestyle? Pin some. • Inspiration – Maybe it’s scripture. But it could be images. Nature inspires. Movies inspire. Heroes inspire. Offer your patient an ideal to pursue by pinning about it. • Health/Fitness – Like food, there are few health conditions that aren’t improved by regular diet and exercise. Pin some tips. Hey Doc, this may sound a bit crazy but marketing is full of crazier stuff than this. Imagine what thoughts you would hear from Pinterest users. If you’re pinning, then you’re part of the conversation. And when you re-pin or invite others to pin with you, you just might start hearing what women want.
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Tim C. Nicholson is the President of Bigfish, LLC. His Memphis-based firm connects physicians, clinics and hospitals to patients and one another through healthcare social media solutions, branding initiatives and websites. His column, “Hey Doc”, appears here monthly. Find him on twitter @timbigfish or email firstname.lastname@example.org
Healthcare Leader, continued from page 1 edge to help and heal. Immediately after completion of his PhD, he was accepted into medical school and subsequently completed his MD at Kansas. As a faculty member at Louisiana State University Health Science Center, Rayford worked with many physician leaders in hospital administration and was inspired to pursue an MBA. He strongly recommends that more physicians consider pursuing an MBA through the University of Tennessee’s Physician Executive Program, which provides physicians with a well-rounded knowledge of business – with an emphasis on the business of medicine. “Healthcare is changing so rapidly that to keep abreast of the changes and to play an active role as opposed to a passive role in these changes requires a physician to have some knowledge of that side of what we do,” Rayford said. Urology, a fascinating field, attracted Rayford. “When I first started, the field of prostate cancer was wide open, and that created an opportunity to pursue research efforts. Combining my PhD with an interest in urology, and particularly oncology, was a perfect fit.” His extensive research has ranged from determining the PSA (prostate-specific antigen) profile of African-American men of different ages to looking at psychosocial aspects of prostate cancer screening, early detection efforts, understanding the mechanism by which prostate cancer progresses — and its benign component — and ultimately to his current focus on integrating business intelligence (BI) with prostate cancer prediction. “Using BI and the field of predictive analytics, based upon a subject’s pattern, I hope to predict whether (1) that subject will develop prostate cancer, and (2) whether that subject is at increased risk of dying from prostate cancer. Using information technology and state of the art algorithms to predict early identification as well as progression of the disease is a new area that I find extremely exciting.” Rayford expects that a workable predictive model might be in use within the next two to three years. But the project that may make even greater waves in the world of medicine is aimed at dramatically improving the exchange of vital information between professionals. “I’m working on developing a platform in which physicians and other healthcare professionals can effectively communicate about all aspects of prostate cancer. My vision is that if we had an electronic collaboration platform at our fingertips on which we could all communicate, then we’d be more likely to identify the most important aspects of the disease from early detection to treatment to clinical trials to advanced disease – and could ultimately eliminate healthcare disparities.” As president and CEO of Q Leap Health, Inc., the business that will be making such a medium available, Rayford expects to introduce it as market-ready for prostate cancer collaboration within the next six months. “Hopefully we can use 10
a similar platform for other conditions as well,” he said. An early adopter of robotic approaches to treat prostate cancer, Rayford has been using this less-invasive approach to removing cancer in its early stages for seven or eight years, and notes that this is still the newest treatment option from a surgical standpoint. Strongly goal-oriented, he lists one primary goal as “serving well as the president of Bluff City (Medical Society); I want to represent the membership in the best way that I possibly can. I think I can do that by focusing on things that bring value to them as physicians and as an organization. That includes helping physicians try to get a better understanding of the business of medicine and play an active role in the community as well, working to educate the community about different disease processes and putting a mechanism in place to help reduce or eliminate health disparities.” As section chair of urology for the National Medical Association, and president of its R. Frank Jones Urological Society, Rayford aims to ensure that the gains of the last two decades with regard to prostate cancer screening in high-risk populations are not lost due to recent guideline concerns regarding PSA screening, as well as to focus on other issues important to NMA’s membership. Rayford, with three sons and two granddaughters, comes from a family filled with healthcare professionals, including a brother who is a cardiologist practicing in Jackson, Miss. His broad scope of interests is evident in his recreational preferences, too – he enjoys working out, exercising, biking, swimming, reading and traveling. By nature an active, eager investigator and leader who appears most comfortable with an overflowing plate of plans and projects, Rayford still modestly denies being an overachiever. “There are a lot of people who have achieved much more than I have in a shorter time span!” he said. Along with his other accomplishments, Rayford cites a return to his roots. “I like the fact that I’m practicing in an area where I grew up and I’m able to be a role model for some of the kids in the community, and also to provide care to family members who are at that point of need.” His advice to those entering the healthcare field: “Follow your dreams, identify mentors along the way who can help point you in the right direction, be very diligent in your pursuit — and more important than anything, have a very strong relationship with God.” Those wanting more information about the medical collaboration platform can email email@example.com.
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In Case of Emergency Tennessee Department of Health’s Role in Protecting the Population By CINDY SANDERS
Between immunizations, primary care services, licensure and regulation of health facilities, analyzing health statistics and launching preventive care initiatives, it’s easy to think of the Tennessee Department of Health as more ‘Clark Kent’ than ‘Superman.’ Yet, as the recent multi-state fungal meningitis outbreak clearly reminded us, addressing emergency situations is a key part of the TDH’s core function. In fact, the department was primarily established to combat lifethreatening outbreaks of cholera, yellow fever and other deadly diseases in the late 1880s. Preventing or stopping public health threats remains a top priority. Sometimes those threats warrant local, state or national attention, but often the TDH staff quietly goes about that part of their workday without much fanfare. “Our mission is to protect, promote and improve the health and well-being of Tennesseans. The emergency preparedness aspect is all about protecting the population,” noted TDH Commissioner John Dreyzehner, MD, MPH. The types of emergencies range from natural or manmade disasters to addressing or preventing communicable and infectious
diseases to investigating outbreaks. “We take an all hazards approach,” explained Dreyzehner. “We never know when the next event will be … but we know it’s coming.” With the State Public Health Laboratory in Nashville and additional labs in east and west Tennessee, the TDH has approximately 130 staff members who perform close to 1.5 million lab tests annually. Not only do the labs have the ability to run a broad spectrum of health assays, the staff
also is called upon to analyze substances of concern, such as an unidentified powder, that might come to the attention of law enforcement officials. “This occurs more frequently than people realize,” Dreyzehner noted. While biohazards are a small part of the overall lab workload, the state labs also play an integral role in analyzing environmental samples, conducting newborn screening panels, and identifying West Nile and other arboviral diseases. Equally important is the state’s work in preparing for threats that haven’t yet arrived. “Right now we have spent a good bit of time and resources on MERS-CoV — Middle East respiratory syndrome coronavirus — and H7N9, a new strain of flu,” Dreyzehner said. “I hasten to add that neither of those have come to our shores.” Being ready, however, has set Tennessee apart. When H1N1 did strike America several years ago, the State Public Health Lab was on the forefront of running tests. At one point, Tennessee was doing testing for other states that didn’t yet have the capacity to analyze incoming samples. Since health threats come from many
different arenas, it’s difficult to anticipate every scenario. “A key lesson is we never know where the next hazard is going to come from. We have spent a lot of time creating the infrastructure, relationships, tools, and capacity to respond to any hazard,” explained Dreyzehner. That was made abundantly clear in the recent issues with preservative-free methylprednisolone acetate (MPA). He noted that in the fungal meningitis outbreak, the TDH relied heavily on the relationships and partnerships that were put in place well in advance of the crisis to effectively work with victims and to communicate information both internally and externally. “We were able to use some existing capacities in some very innovative and novel ways to great success,” Dreyzehner said. One example, he noted, was using preparedness software developed for another purpose to track patients who had been exposed to the tainted MPA. The team also relied on their capacity to collect and analyze data to predict the most effective treatment protocols and to identify those at risk. As Dreyzehner pointed out, going into this crisis there was virtually no literature on the particular type of fungus involved in the meningitis outbreak. (CONTINUED ON PAGE 21)
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The CHS, HMA Chess Match Continues Acquisition Would Create the Nation’s Largest For-Profit Hospital Chain per Facility Number By LYNNE JETER
FRANKLIN, Tenn. – Federal subpoenas, contract disputes, lower admissions, rising bad debt, and a reduction in surgeries contributed to a move that industry watchers now say was predictable. On July 30, Community Health Systems (Nasdaq: CYH), a Franklin, Tenn.based hospital operator, announced plans to acquire Health Management Associates Inc. (NYSE: HMA), a Naples-based hospital group that, ironically, had been on a spending spree acquiring struggling hospitals. In late March, Fortune magazine had named HMA among the World’s Most Admired companies in Health Care: Medical Facilities for the second consecutive year and fifth time in seven years. HMA has also been named the leading company for two subcategories in 2012: Use of Corporate Assets and Social Responsibility. Yet soon after HMA CEO Gary Newsome announced retirement plans in May to preside over a Uruguay mission with the Church of Jesus Christ of Latterday Saints, rumblings swept through Wall
Street that the fiscally struggling public company might be the target of a takeover. In a May 31 note to investors, Chris Rigg, an analyst with Susquehanna Financial Group, was cautiously optimistic that CHS might be pursuing HMA, estimating the company could be acquired for $18.50 a share, a premium to HMA’s shares that had recently traded near $14. “We would be surprised if a transaction were announced in the very nearterm,” he noted. “We don’t believe CEO Gary Newsome would be leaving the company in July if a formal auction process, which we expect HMA would conduct, were currently underway. That being said, we believe Community is the best-positioned name in the hospital group to operate HMA rural focused hospital assets.”
In a power play, the move became official when CHS announced plans to acquire HMA for $3.9 billion in a deal valued at $7.6 billion, creating the nation’s largest for-profit hospital chains in terms of number of facilities. “This is the second biggest hospital deal announced this summer,” said healthcare industry consultant George Paul, antitrust partner with White & Case. In June, Dallas-based Tenet Healthcare Corp. (NYSE: THC) announced its acquisition of Nashville, Tenn.-based Vanguard Health Systems (NYSE: VHS) in a pact valued at $4.3 billion. “This deal is part of a growing wave of hospital consolidation, as hospitals seek ways to diversify and lower costs in anticipation of a sea change occurring in the healthcare industry with the implementation of the Affordable Care Act, uncertainty over how states will handle Medicaid coverage and reimbursement, and Medicare changes,” he said. Paul emphasized that under Obamacare, scale will matter greatly as hospitals 12
seek to cope with reimbursement changes and as consumers become increasingly price sensitive. “Insurers will pressure hospitals to become more efficient than ever, and as a result, it’s not surprising to see these two companies merge,” he added. With a similar focus on non-urban locations, CHS leases, owns or operates 135 hospitals around the country. With HMA’s 71 hospitals, CHS would have 206 acutecare hospitals. The antitrust review will focus on highly localized markets, Paul pointed out. “While the two parties overlap in 29 states, it doesn’t appear that they have substantial overlaps on a localized level,” he explained. “The Federal Trade Commission (FTC) will focus on how many patients in an area would likely view the two operators as substitutes for each other in terms of location, quality and specialties. Where the two are close substitutes, the FTC could seek divestitures if it were to find that patient choice may be limited.” The new CHS would be rivaled only by its across-town neighbor, Nashville, Tenn.-based Hospital Corporation of America (HCA), which has fewer hospitals (162), yet reports higher revenue. Last year, HCA raked in $33 billion; CHS and HMA had a combined $18.9 billion. “This compelling transaction provides a strategic opportunity to form a larger company with a diverse portfolio of hospitals that is well-positioned to realize the benefits of healthcare reform and to address the changing dynamics of our industry,” said CHS CEO Wayne Smith. “Our complementary markets and the ability to form networks in key states, along with the synergies that will be available to us, can create value for the shareholders of our companies, the communities we serve, our employees and medical staffs.” Both companies’ boards of directors unanimously approved the definitive merger agreement. The deal would give HMA shareholders a 16 percent stake in the new company. Before the market opened on July 30, the day of the announcement, HMA shares fell 6.9 percent to $13.89; CHS stock rose 2.4 percent to $48.35.
The relationship between HMA and its largest shareholder (14.6 percent), Glenview Capital Management, a hedge fund managed by billionaire Larry Robbins, had soured in recent months. Glen-
view, a private investment management firm established in 2000 with more than $6 billion of assets, also owns nearly 10 percent of CHS. Robbins had been critical of HMA’s sluggish financial results and “unconstructive” executive behavior, pointing to HMA CFO Kelly Curry. Glenview had tried to replace HMA’s entire board of directors with eight candidates in a Fresh Alternative campaign to revitalize the company. In June, Glenview had written HMA about “significant room for improvement,” which it said had fallen short in its financial performance for more than a decade. “Under the supervision of the sitting board, HMA lacks the financial acumen to deliver on its projections,” Glenview released in a July 30 statement. “Unfortunately, this continues to be the case.” Another Nashville, Tenn.-based hospital group, LifePoint Hospitals (NASDAQ: LPNT), had also expressed interest in acquiring HMA. Smith said he considered keeping CHS an independent company and explored partnerships with other companies but decided acquiring HMA would “create value for the shareholders of our companies, the communities we serve, our employees and medical staffs.”
The Next Step
Until the merger is completed – the target deadline is March 31 – John Starcher Jr., president of HMA’s Eastern Group with 23 hospitals in seven states, will step up as HMA interim CEO. HMA’s projected second-quarter earnings show a drop of .05 percent in net revenue to $1.46 billion, attributing the discouraging fiscal picture to low admissions, increases in observation stays, higher bad debt, a reduction in surgeries, and the federal government’s sequestration. Same-hospital admissions were predicted to fall 6.7 percent, compared to the second quarter of 2012. In its first-quarter financial filing, HMA reported it had received a subpoena from the U.S. Securities and Exchange Commission (SEC) for documents involving accounts receivable, billing write-downs, contractual adjustments, reserves for doubtful accounts, and revenue. In May and June, HMA received three more subpoenas from the HHS’s Office of Inspector General related to the process by which the company admits people from its emergency department. The new subpoenas supplemented ones the company received in 2011. Another subpoena was issued on physician relationships. In December, a CBS “60 Minutes” segment focused on HMA’s aggressive policies aimed at increasing admissions and “disgruntled former employees.” No stranger to the federal pressure-cooker, CHS recently received a new subpoena for similar allegations from the Department of Justice.
Hot topics in HealtH law by John Arnold
Representing Physicians, Hospitals and Healthcare Providers since 1975
CMS Proposes Broadening Medicare Enrollment Restrictions To Combat Fraud The Centers for Medicare and Medicaid Services (CMS) in April proposed several changes to the conditions for payment regulations governing Medicare enrollment (42 C.F.R. § 424.530) and the revocation of Medicare enrollment and billing privileges (42 C.F.R. § 424.535). Together, these changes would empower CMS with even greater authority to deny or revoke Medicare enrollment privileges as a means of combating fraud and abuse. As CMS evaluates comments and prepares to issue a final rule, Medicare providers and suppliers should be aware of three important changes CMS has proposed. First, CMS proposes to expand its ability to deny enrollment for unpaid Medicare debt. Currently, CMS screens the enrolling provider, supplier, and the owner thereof for current overpayments. CMS, however, believes it is necessary to broaden the screening process to address situations where individuals and entities exit Medicare with sizeable debts and attempt to re-enter the program through new entities. Consequently, CMS proposes to extend screening to other entities the owner had a previous relationship with, and expand the inquiry from overpayments to Medicare debts generally. In the final rule, providers and suppliers should pay close attention to how CMS addresses the meaning of a Medicare debt. Additionally, based on comments in the proposed rule, providers and suppliers should not be surprised if the final rule goes even further and allows CMS to deny enrollment based on the unpaid Medicare debt of managing employees. The second important change would broaden CMS’ discretion to deny or revoke enrollment based on felony convictions. The current framework allows CMS to deny or revoke enrollment privileges if a provider, supplier or owner was convicted within the last 10 years of a serious felony (rape, murder, assault, etc.) or felony that poses an immediate risk to Medicare or its beneficiaries. The proposed rule would extend screening for felony convictions to all managing employees and adopt a more discretionary standard for determining what constitutes a disqualifying felony. Specifically, rather than limiting screening to only certain felonies, CMS would have the discretion to deny or revoke enrollment privileges based on a conviction for any felony CMS deems detrimental to the best interests of Medicare or its beneficiaries. While this standard will almost certainly include the felonies CMS currently screens for, providers and suppliers should evaluate the final rule for additional guidance on other types of felonies CMS considers detrimental to the Medicare program. The third, and perhaps most troubling change, would allow CMS to revoke the enrollment of providers and suppliers with a pattern or practice of billing for services that do not meet Medicare requirements. Of particular importance, CMS specifically emphasized the requirements that claims must be reasonable and necessary, noting that a common situation in which revocation “could apply would be one where a provider or supplier is placed on prepayment review and a significant number of its claims are denied for failing to meet medical necessity requirements over time…” Although CMS stressed it would revoke enrollment status only when an unusually high number of claims fail to meet Medicare requirements, providers and suppliers should pay particular attention to how the final rule limits or clarifies the ill-defined “pattern or practice” standard.
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FORCE: Facing Our Risk of Cancer Empowered, continued frompage 6 than five percent. She is passionate about helping other women through the process via the new FORCE chapter in Memphis. Her hope is to provide regular support meetings and help others by email and phone as well. Director of Genetic Counseling at The West Clinic, Carrie Horton, MS, CGC, recommends FORCE as a resource for her clients and their families. “Cancer genetic counseling is the process of helping people understand and adapt to the medical, psychological, and family implications of hereditary cancer conditions,” said Horton. “During a genetic counseling appointment, we interpret the family history and provide education on genetic testing and management of inherited conditions. The goal is to promote informed decision making and advocate for the client’s wishes. We often use groups like FORCE as a resource for clients and their families to feel connected to others in similar situations.” Regina Nuccio, MS, CGC, a genetic counselor at Baptist Memorial Health Care Corporation, also uses FORCE as a resource. “FORCE invites patients with a hereditary breast cancer syndrome to connect with other men and women going through the same thoughts, feelings, and decision-making processes as they are. FORCE is also a major advocacy group that informs patients about clinical trials, legal issues affecting mutation carriers, local and national events, and even a gallery of post-mastectomy and reconstruction photos submitted by members. While we as healthcare professionals can provide valuable information to patients and their families, there’s nothing like connecting with another person who’s walking through exactly what you are.”
Whether it’s during the day or after hours, our board certified physicians are on hand for life’s unexpected moments.
Over one million people in the United States carry the BRCA gene or other hereditary factors that puts them at a high risk of cancer. The BRCA gene is more prevalent
Memphis Medical News
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DONATE FORCE Memphis is just getting started so there are many ways to help. They have a first year goal of raising $5000 to get this chapter going. Your donations will help make that happen. BUY JEWELRY In October, the Brighton Collectibles shop at Saddle Creek will help the new FORCE chapter raise money by donating a portion of its sales to FORCE Memphis.
AWARENESS AND EDUCATION
Physicians who have patients who may be at a higher risk of cancer due to family history, should make them aware of BRCA gene mutation testing and the new FORCE chapter in Memphis.
Volunteer your time or professional skills to this new chapter. Contact Irene Rodda at (901) 232-5684 or email: email@example.com. You can also see Rodda’s blog at www.facingyourrisk. org/Memphis. If you know of a local non-profit or charitable organization worthy of being spotlighted in Memphis on the Mend, contact Pamela Harris at firstname.lastname@example.org.
Child Life Specialists, continued from page 8 diagnosis, and another which studies costsavings of Child Life programs. It’s a drop in the bucket of what may come later. Grissom said there is almost no research being conducted in the area of Child Life, even though the children who survive exhibit remarkable qualities like
among those with Eastern European (Ashkenazi Jewish) heritage. One out of every 40 Jewish people carries a mutation of the BRCA I or II gene. Children have a 50 percent chance of inheriting a parent’s high cancer risk. A blood test that runs about $500 can determine whether the BRCA mutation runs in a family. The cost of the test may be covered in part or in full by insurance. Women who develop breast cancer before age 50 are more likely to have a BRCA gene mutation than those who develop it after age 50.
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an adult-like maturity. “It’s like a bunch of little adults running around,” said Grissom. “Children’s hospitals tend to be joyful places because children are resilient and they move through things unlike adults do. They see who they want to become. They see what they have to do. They learn things that most children don’t learn.” Part of their maturation often is expressing the desire to give back and help others. “By watching the staff and seeing what’s been given to them, (patients) see the relief that mom and dad have from being here at St. Jude, and they want to give back as much as they can,” said Grissom. “It’s pretty amazing. Children want to sell cookies or crafts so they can give us their quarters.” memphismedicalnews
Shining a Light on Physician, Industry Relationships Physician Payments Sunshine Act Now in Effect By CINDY SANDERS
If you’ve recently enjoyed a golf outing with your friendly pharmaceutical rep or a nice dinner with a device manufacturer, that information will soon be available for all to see. The Physician Payments Sunshine Act went into effect Aug. 1 of this year and requires applicable manufacturers to report certain interactions with physicians and teaching hospitals that are deemed to have value. ‘Applicable manufacturers’ are defined as pharmaceutical, device, biologic and medical supply manufacturers whose products either require a prescription to be dispensed or for which payment under federal healthcare programs is available. “The Sunshine Act generally applies when physicians or teaching hospitals receive transfers of value from applicable manufacturers, and the applicable manufacturers receive actual or potential value in return,” explained Tom Baker,8/19/13 a Tom KitsonAd_10x6.38_Ad 1:31 Baker PM Page 1
shareholder in the Baker Donelson Health Law group. Baker, who practices in the firm’s Atlanta office, pointed out the manufacturer doesn’t actually have to receive financial benefit in exchange for the ‘value transfer,’ which can take a wide variety of forms, including donated items, payment to a physician for consulting services or expenditures for entertainment. “It’s enough that it might influence a physician,” he noted. “The Sunshine Act is about transparency in two different fundamental ways,” he continued. “First, there is the potential interference in medical judgment in clinical trials required for FDA approval of drugs or medical devices. Second, there is potential interference in medical judgment in terms of ordering an item or service for which federal reimbursement is available.” Baker said the policy is to shine a light on interactions that could be construed to unduly influence a physician or teaching hospital and to ferret out conflicts of interest. “It’s not saying that transfers of value are, per se, illegal but that the public has a right to know when medical judgment
might be influenced by the value transfer,” he continued. Relationships between physicians and industry will now be on display for patients, auditors, personal injury lawyers and others to see when the Centers for Medicare and Medicaid Services (CMS) begins publishing the reported data next fall.
The Back Story
Championed by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.), the impetus behind the Sunshine Act came from mounting concern over potential conflicts of interest within the industry. These conflicts were highlighted by several egregious incidents involving clinical trials and devices up for FDA approval where physicians received large payments from the manufacturers of the drugs or devices being studied. Grassley publicly described a number of academic physicians taking money from the National Institutes of Health when those physician-scientists had direct financial interests in their own research. Among the worst offenders, the former chairman of the Psychiatry Department at Stanford University received an NIH
grant to study a drug when he owned $6 million in stock in the company seeking FDA approval. Similarly, the former chair of the Psychiatry Department at Emory failed to report hundreds of thousands of dollars from GlaxoSmithKline while researching the company’s drugs. Harvard also had to discipline three researchers who received almost $1 million each in outside income while heading up several NIH grants. Outside of these flagrant examples, the concern persists that much smaller gifts might also influence medical decisions. Earlier this year, Pew Charitable Trust published Persuading the Prescribers: Pharmaceutical Industry Market(CONTINUED ON PAGE 18)
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Memphis Pathologist: Genetics Providing Key Information, continued from page 1 They are designed primarily to identify what molecular pathways of growth, proliferation, differentiation and specialization are activated in the tumors and how they compare with normal tissue. Research has identified several tumors with abnormally turned “on” pathways. A few targetable biological agents have been developed to attach to the cells and turn off abnormal pathways, ceasing proliferation and growth. “This will hopefully make the tumor shrink and allow the body’s immune system to make it disappear with standard chemotherapy or make the tumor more amenable to standard chemotherapy,” he said. According to Groshart, the role of the pathologist is to give the most information to the medical oncologist as soon as possible so they can customize treatment options. “After a tumor is excised by a surgeon,” he said, “the next visit a patient has is with the medical oncologist. Why waste a medical oncology visit? Otherwise that puts the patient another few weeks down the road before they can get therapy.” In some instances, as with melanomas and lung cancers, the tumor often gets resistant to the targeted agent. While the drug is working, it is more effective than chemotherapy, and the patient has fewer side effects. “The promise of the therapy is so strong that people are trying to develop drugs in these multi-step pathways to block the multiple steps,” Groshart said. “Then one can use these drugs sequentially or in combination.” Another cancer test available through Trumbull is the Oncotype-DX® test, which through molecular analysis explains how aggressive a breast tumor with estro-
Dr. Kenneth Groshart
gen receptor is, predicting its propensity to recur over the next three years. Special breast cancer staining has been available for many years to help predict responsiveness to breast-specific interventions. The stains determine whether the tumor is HER2-neu receptor, estrogen receptor or progesterone receptor positive. For example, if the patient is positive for HER2-neu, she is a candidate for antiHER2 drugs, Herceptin® and Kadcyla®, both of which are antibody-type drugs attaching to the cell surface HER2 marker. Herceptin has been around a few years, but Kadcyla® is a new generation of drug, containing a strong cellular poison that is not released until it gets inside the cancer cell because of the HER2-neu receptor and then metabolically kills it, leaving the normal cells healthy.
With the above three special stains and standard tumor evaluation under the microscope, the pathologist can help guide Oncotype-DX® testing via a proliferative index marker. Of the four pathologic groupings of breast cancer, it is applied to so-called Luminal B tumors. “It’s a surrogate for some of the info that’s on the Oncotype-DX® Breast,” Groshart said. “However, if it is a triple negative, it is particularly difficult to treat. Vanderbilt is currently studying triple negative breast cancers, and their progress will change the way we do chemotherapy.” In all cancers, the research proliferates nearly as quickly as the cells, giving pathologists and oncologists more information. Originally, the thought was only 5 percent of lung adenocarcinomas had targetable sites, but it is now known that actually around 15-20 percent do. Researchers have found a couple of targetable sites within squamous lung cancer in the last year, and that information is being shared with drug companies that are trying to find targetable agents, he said. Meanwhile, there is research on prostate tumors that won’t be ready for some time but is pivotal. Currently, pathologists can diagnose such tumors, but some might not cause a problem and others might cost a man his life. Profiles are being developed to show predictability of metastatic disease across the range of prostate tumors. Also promising are the upcoming innovations in getting the immune system to recognize tumors. There are some promising findings in melanoma. Mainly recognized as a skin cancer, melanoma can derive from the gastrointestinal tract, the oral cavity and in epithelial tissue within membranes of the genital tract or in the
pigmented epithelium of the eye. Within the 45 percent of melanomas unhelped by a targeted agent, there are a couple of drugs that turn on the immune system to the unique proteins on the tumor. “Exciting stuff,” Groshart said.
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New Lines of Research
NCI Data Set Opens Access to Cancer-Related Genetic Variations By CINDY SANDERS
How will this breast cancer drug react in patients that are HER2 positive? Will this new lung cancer therapy work in a patient with multiple genetic variations? Finding answers to those questions just got a bit easier with the rollout of a vast data set of cancer-specific genetic variations by scientists at Dr. Yves the National Cancer InPommier stitute (NCI). Yves Pommier, MD, PhD, chief of the Laboratory of Molecular Pharmacology at the NCI, was one of three lead researchers on the study, published July 15 in Cancer Research, that pinpointed more than six billion connections between cell lines with mutations in specific genes and the drugs that target those genetic defects. Paul Meltzer, MD, PhD, chief of the Genetics Branch at the Center for Cancer Research and James Doroshow, MD, director of the Division of Cancer Treatment and Diagnosis, were the other principal investigators. Pommier explained the new database builds upon the NCI-60 cancer cell line collection, which is comprised of nine different tissues of origin – breast, ovary, prostate, colon, lung, kidney, brain, leukemia and melanoma. In their Cancer Research article, the authors note the NIC-60 panel is the most frequently studied human tumor cell line in cancer research and has generated the most extensive cancer pharmacology database worldwide. “Most of the cell lines are from cancer tissues that are hard to treat and are usually resistant to therapy,” he said. “The genomic database is unmatched and enables researchers to mine all the gene expression in relationship to a drug.” Pommier continued, “Each drug has a different profile in the cell line because they act on different targets.” In this most recent study, the investigators sequenced the whole exome of the full NCI-60 cell lines to define novel cancer variants and deviant patterns of gene expression in tumor cells. “The whole genome for the cell line has never been done before,” he said. “Many, many genes had never been sequenced.” The researchers cataloged the genetic coding variations, developing a list of possible cancer-specific gene aberrations. The group then used the Super Learner algorithm to predict the sensitivity of cells with variants to more than 200 anti-cancer drugs … those approved by the FDA and those still under investigation. By studying the correlation between the gene variants – such as TP53, BRAF, ERBBs, and memphismedicalnews
ATAD5 – and anti-cancer agents including vemurafenib, nutlin and bleomycin, the researchers were able to predict outcomes, showing one of the many ways the data could be used to validate and generate novel hypotheses for future investigation. Access to the data is freely available through multiple sources including the CellMiner and Ingenuity websites. By opening up the scalable data on the whole genome sequencing and drug connectivity, Pommier and his colleagues hope to help other researchers connect cancer-specific gene variants with drug response to move the science forward. “It’s an evolving system,” he said, adding that profiles on drugs in clinical trials will be added to the database as information becomes available to keep the data set current. In explaining how the system works, Pommier said a researcher interested in a specific agent could plug that drug into the database. “You’ll get the profile activity of the drug, and then you can ask if there is any match to any specific gene mutations,” he said. From there, Pommier continued, the researcher could query, “Are these cells more resistant or receptive to the drug?” Getting those answers rapidly should help researchers move major lines of oncology drug development toward personalized medicine to achieve optimal outcomes in a safer, more efficient and effective manner. With the added knowledge provided by the data bank, Pommier said researchers might separate patients into groups based on their genetic profile and therefore be able to use specific drugs in a more rational manner. “Between a targeted drug and a clinical application, you need a verification in the middle,” he stated. That’s just what this new database offers.
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Shining a Light, continued from page 15
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entertainment. “It’s enough that it might influence a physician,” he noted. “The Sunshine Act is about transparency in two different fundamental ways,” he continued. “First, there is the potential interference in medical judgment in clinical trials required for FDA approval of drugs or medical devices. Second, there is potential interference in medical judgment in terms of ordering an item or service for which federal reimbursement is available.” Baker said the policy is to shine a light on interactions that could be construed to unduly influence a physician or teaching hospital and to ferret out conflicts of interest. “It’s not saying that transfers of value are, per se, illegal but that the public has a right to know when medical judgment might be influenced by the value transfer,” he continued. Relationships between physicians and industry will now be on display for patients, auditors, personal injury lawyers and others to see when the Centers for Medicare and Medicaid Services (CMS) begins publishing the reported data next fall.
The Back Story
Championed by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.), the impetus behind the Sunshine Act came from mounting concern over potential conflicts of interest within the industry. These conflicts were highlighted by several egregious incidents involving clinical trials and devices up for FDA approval where physicians received large payments from the manufacturers of the drugs or devices being studied. Grassley publicly described a number of academic physicians taking money from the National Institutes of Health when those physician-scientists had direct financial interests in their own research. Among the worst offenders, the former chairman of the Psychiatry Department at Stanford University received an NIH grant to study a drug when he owned $6 million in stock in the company seeking FDA approval. Similarly, the former chair of the Psychiatry Department at Emory failed to report hundreds of thousands of dollars from GlaxoSmithKline while researching the company’s drugs. Harvard also had to discipline three researchers who received almost $1 million each in outside income while heading up several NIH grants. Outside of these flagrant examples, the concern persists that much smaller gifts might also influence medical decisions. Earlier this year, Pew Charitable Trust published Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients, which stated the drug industry spent nearly $29 billion marketing their products in 2011 (Source: Cegedim Strategic Data). Of that amount, $25 billion was spent directly marketing to physicians. After unsuccessfully introducing the legislation in 2007, the Sunshine Act was incorporated into the Affordable Care Act. A couple of missed rulemaking deadlines by CMS pushed the law’s effective date to Aug. 1, 2013 for the balance of this calendar year and requires annual report-
ing going forward.
What is a Transfer of Value?
With 12 major exceptions (see box), any direct payment or transfer of value of $10 or more (or an aggregate of $100 or more in a calendar year) to a physician or teaching hospital must be reported. Additionally, indirect transfers through an intermediary or third party are also subject to reporting. There are 14 main reporting categories. These include consulting fees, (CONTINUED ON PAGE 20)
12 Key Exemptions to the Reporting Rule Certified and accredited CME. Buffet meals, snacks, coffee breaks that are provided by a manufacturer at a large-scale conference or event when the items are generally available to all attendees. Product samples that are not intended for sale and are for patient use. Educational materials that directly benefit patients or are intended for patient use. The loan of a medical device for evaluation during a short-term trial period (not to exceed 90 days). Items or services provided under a contractual warranty in the purchase or lease agreement for a device. The transfer of any item of value to a physician when that physician is a patient and not acting in his or her professional capacity. Discounts including rebates. In kind items for use in providing charity care. A dividend or other profit distribution from, or ownership or investment in, a publicly traded stock or mutual fund. Transfer of value to a physician if the transfer is payment solely for the services of the physician with respect to a civil or criminal action or an administrative proceeding. A transfer of anything with a value of less than $10 unless the aggregate amount transferred to, requested by, or designated on behalf of the physician exceeds $100 in the calendar year.
Making Geriatrics a Primary
National expert discusses decade of change in high demand specialty By LYNNE JETER
TALLAHASSEE— Ken BrummelSmith, MD, almost bypassed specializing in geriatrics because of the lack of educational opportunities at medical schools during the early 1970s, when he attended, and the lack of geriatric residency slots nationwide. Instead, it was a chance encounter that sculpted his career path and enabled him to establish the nation’s first Department of Geriatrics for an allopathic school. “My first job after fellowship was teaching a family medicine residency, and my director told me about the Society of Teachers of Family Medicine having a conference on teaching geriatrics in the family medicine residency program, and said it was going to be a big deal someday. When asked if I’d go and see Dr. Ken what I could find out BrummelSmith about it, my first thought was, wow! A free trip to Boston! I really didn’t have much knowledge about geriatrics then,” said Brummel-Smith, past president of the American Geriatrics Society, and founding chair of the Department of Geriatrics at the Florida State University College of Medicine (FSU-COM). “After
getting enthused at the conference and involved in developing educational programs, I switched from family medicine to geriatric medicine.” Since then, the field of geriatrics has exploded. As baby boomers have aged, the need for geriatricians grows. Currently, 38,000 geriatricians are projected to meet the country’s needs. “We’re at 7,000 now,” said BrummelSmith. “The main problem is we don’t have enough applicants. When I started in 1980, hardly anyone believed it was worth talking about. Now, there’s interest from the general public, but not enough interest from medical students. Lack of money and prestige are two reasons why.” To address the shortage, BrummelSmith routinely encourages high school groups pursuing medical paths to strongly consider geriatrics. “I always give them data that says: if you look at the top income to the lowest income, geriatricians are at the bottom of the scale,” he said. “We actually make less money with a specialty in geriatrics than we would in our primary specialty of family medicine or internal medicine. But interestingly, you can line up the reverse in job satisfaction. Geriatrics has the highest; neurosurgeons, among the highest paid, have the lowest. We tell them to think about
paying your bills and your loans, but don’t think you need to sacrifice your life to do it. Choose a specialty you love rather than one that pays well. And you’ll be happy the rest of your life.” Brummel-Smith also ensures that all FSU-COM medical students have rotations in geriatric medicine in the school’s community-based curriculum model. “Otherwise, if you took 1,000 people in a community, 700 would have a reason for thinking about their health during that month,” he explained, referencing the well-known study, “The Ecology of Care,” which first appeared in the New England Journal of Medicine in 1961, and was recently revisited with similar results. “About 300 would have contact with the healthcare system in some way. About 100 would be admitted to a hospital, and one would go to an academic teaching medical center. So the population of patients who are taken care of, and the doctors taking care of them in an academic medical setting, is almost completely unreal realty. Then medical graduates after residency go into practice where the real situation is. For family medicine physicians, 30 percent will be geriatric patients. For internists, it’s 40 to 50 percent. And they’re just not prepared for it. So during medical school and residency, students get a negative view of geriatrics
because you’re not seeing that many older patients in academic medical centers, and they hardly ever see geriatricians as role models. Combined with the negative financial incentives, and the negative emotional incentives that a lot of academic doctors put on geriatrics, it doesn’t surprise me that few people choose geriatrics.” The tide is slowly turning in favor of geriatric medicine. CMS has elevated geriatrics to primary care status, paying $38,500 per resident annually, a 10 percent payment bonus from $35,000. The shift from production- to value-based medicine will also make a difference. South Carolina has adopted a student loan repayment program as an incentive for geriatricians, a move Brummel-Smith hopes other states will emulate. “In general, there’ll never be enough geriatricians to take care of all people over the age of 65,” he said. Even though baby steps are helpful, it remains problematic for geriatricians, who don’t fit the standard productivity model of many medical groups. “Geriatric patients don’t fit into the 15-minute visit model,” he explained. “Older patients have more medical needs and take longer for each appointment. Also, the way our healthcare system is (CONTINUED ON PAGE 21)
Carpal Tunnel Syndrome & Other Causes of Numbness and Tingling by Ronald C. Bingham, M.D. Physical Medicine & Rehabilitation
umbness and tingling of the hands is a common complaint. Although carpal tunnel syndrome is the most common cause there are many conditions that can mimic this. The four most frequent disorders are outlined below.
Carpal tunnel syndrome (CTS) is the result of a “pinched” median nerve at the wrist and is the most common cause of hand numbness. The median nerve, branches out to the fingers like the limbs on a tree. These branches go to the skin of the fingers and some of the muscles in the hand. When this nerve is “pinched,” it can cause the fingers to become numb or tingle. It also can create weakness or pain of the hand. These symptoms are usually worse at night. This pain can radiate to the forearm and shoulder. In milder cases, a wrist splint worn at night can help. In more advanced cases, a small surgical procedure is necessary.
Ulnar Nerve Impingement: The ulnar nerve, or the “funny bone nerve”, begins in the neck and runs all the way to the hand. When it becomes irritated at the elbow, it can cause numbness in the ring and little fingers, or weakness in the hand. It is uncertain how the nerve becomes irritated, but it is often associated with a hard blow to the elbow or repetitive elbow bending, such as weight lifting. Sleeping with the elbow bent or repeated pressure of the elbow on a desk or chair may also injure the nerve. If you work with your elbows on the desk, try an elbow pad. Splinting the elbow in the straight or extended position at night might also help. A splint can be fashioned from a pillow or towel and tape. If your condition is uncomfortable or seems to be progressive, see your health care provider. Sometimes a surgical procedure is required.
Pinched Nerve in the Neck (Radiculopathy): Radiculopathy results from a herniated disc in the neck or from a bony constriction where the nerve exits the neck. A herniated disc means that some of the material between two of the bones in the neck has protruded and is pinching a nerve. Usually, patients will say that the pain begins in the back of the shoulder and radiates into the arm, forearm and hand, and often will raise their hand over their head for relief. Several types of treatment are available before surgery is considered.
An EMG will allow your health care provider to determine if you are suffering from one of these conditions.
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compensation for services other than consulting, gifts, entertainment, food, travel, charitable contributions, education, grants, research, royalty or licensing fees, current or prospective ownership or investment interest, direct compensation for serving as faculty or a speaker for a medical education program, honoraria. Under the new rules, Baker said a physician could accept a ballpoint pen or pad of sticky notes from a manufacturer without it being included in the annual report, but most meals, tickets, or gifts probably will fall under one of the reporting categories considering the $10 threshold. “The days of the pharmaceutical company taking a group of physicians to the Super Bowl are over … or at least it will be disclosed and expose you to the risk of Anti-Kickback statute prosecution,” Baker said. “It’s the entertainment part of it that physicians would probably like to have exposed the least,” he added. The law also requires applicable manufacturers and GPOs (group purchasing organizations) to report ownership interests by physicians or their immediate family members. It should be noted, however, that purchased industry stocks and mutual funds that are generally available to the public are not reportable. If Dr. Smith buys 50 shares of ABC Pharmaceutical stock, which is publicly traded, it doesn’t have to be reported. If a representative of ABC Pharmaceutical gives Dr. Smith stock, then it does. Ultimately, a patient whose doctor recommends a specific device or drug will be able to search the CMS database to see if there is a connection between the physician and the manufacturer. “You’re going to know when your physician has a personal financial interest in your healthcare beyond the physician’s professional services,” Baker pointed out.
Disputing a Report
Nerve Disease (Neuropathy): A generalized disease of the nerves can cause numbness or tingling in the hands or feet. The most common causes are diabetes and hereditary conditions. Neuropathy usually affects the feet first and then the hands. The numbness usually involves the entire hand rather than only certain fingers and might extend up into the forearm. Numerous medications are available that can minimize the symptoms.
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Shining a Light, continued from page 18
Ronald C. Bingham, M.D.
So what happens if your name appears on a report, and you disagree with the data? Baker said CMS is going to notify physicians of all their reported relationships. Once access is granted to the online portal housing the consolidated report, a physician should have at least 45 days to challenge the data and try to resolve the dispute with the reporting entity. Those who cannot agree will be given an additional 15 days to come to a resolution before the information is made public. If no agreement can be reached, the data will be published but flagged as dis-
More Information for Physicians The American Medical Association has put together the “Physician Sunshine Act Tool Kit” with additional information on the new requirements, a webinar and links to the free mobile app. To access the kit, go online to www.ama-assn.org/go/sunshine.
puted. Physicians cumulatively have up to two years to dispute reports even after the data is published. “While physicians aren’t required to track transfers of value, they are encouraged to do so,” said Baker. “How in the world are you going to be able to refute a report if you don’t have evidence to the contrary.” Baker pointed out you might not think you received an influential ‘gift’ from a device manufacturer by grabbing a bite of lunch, but even a sandwich, tea, tip and tax is often over the $10 threshold. Short of asking to see the bill, it would be difficult to gauge the cost per person at the table; and without a copy of the receipt, it would be difficult to dispute the reported item. “As a practical rule, doctors probably aren’t going to be good at refuting the evidence,” Baker said. However, he added, CMS has created a smartphone app with a version for industry and another for physicians to make it easier to keep track of reportable transfers. “Open Payments Mobile” is available at no charge through the Apple Store and Google Play Store.
Data accumulation for 2013 has already begun. Below is a timeline of upcoming key dates in the process. • Jan. 1, 2014: Anticipated launch date for CMS physician portal where doctors can register to receive notice when their individual consolidated report is ready for review. This portal also provides a means for physicians to contact manufacturers and GPOs about disputes in accuracy. • March 31, 2014: Partial year data (August-December 2013) must be turned into CMS. • June 2014: Anticipated access to individual consolidated reports from 2013. Physicians have a minimum of 45 days by law to seek corrections or modifications to the information by contacting manufacturers/GPOs through the portal. September 2014: Searchable reports are published and open to the public.
“The act itself is vexing,” said Baker. Adding to the frustrations, he continued, is that CMS is interpreting the Sunshine Act very broadly. “The applicable manufacturers are not going to take any chances,” Baker continued. He noted, those who accidentally fail to disclose required data will face penalties of not less than $1,000 and not greater than $10,000 per incident up to a cap of $150,000 annually. Those who knowingly withhold reportable information face penalties between $10,000 and $100,000 for each value transfer with an annual cap of $1 million. “Physicians need to know other people are going to be talking about them,” concluded Baker. “One would hope everything reported is within the legal boundaries … but if you are testing those boundaries, you better stop.”
In Case of Emergency, continued from page 11 “We were dealing with a situation that no one had ever encountered before.” Calling on relationships with federal agencies, national experts, and academic centers, Dreyzehner said the team quickly gathered and disseminated information to local provider resources across Tennessee — including public health nurses and county public health staff — who have regularly reached out to inform and update those impacted by the tainted MPA. Dreyzehner was quick to add this work is ongoing. “More than 13,500 people were affected by this … ranging from disconcerting to catastrophic,” he said. “This is still affecting more than 700 people around the country — 749 cases have Dr. John currently been identified, Dreyzehner and 63 people unfortunately lost their lives. The need for a rapid and accurate information loop has spurred the state to enhance communication tools. “We need to be able to push our information to our healthcare partners and receive information from them in a more real time and cooperative space,” explained Dreyzehner. To that end, he said Tennessee is creating the Health Joint Information Center, which is a concept derived from the National Incidence Management System. “In order to provide the best information to the public and media partners, we create a place where partners and entities can pool information to make sure we are providing the right answers in a rapid fashion.”
Ultimately, it all comes down to building a scalable infrastructure, and a big part of that infrastructure comes from creating and maintaining relationships. “An emergency is the last place you want to be meeting people for the first time,” Dreyzehner pointed out wryly. The smooth interaction between local providers, the TDH staff, and federal officials during the meningitis outbreak underscored just how important it was to have previously developed relationships in place when it came time to act. “Just like community health providers and centers are our eyes and ears, the state health departments are the eyes and ears for the CDC,” Dreyzehner said. “We in public health rely on a variety of surveillance tools to detect concerns and to protect health,” he continued, adding the TDH relies on local healthcare personnel, hospitals and health departments to draw attention to concerns. “We’re always thinking of the continuum of reporting,” Dreyzehner continued. The first call, he added, should be to the local health department to report the incident. “They are certainly able to escalate that rapidly if there is a need,” he said, adding each department has a medical director and direct access to the state’s subject matter experts. Dreyzehner said the best defense to protect against or respond to public health threats is working together. “To the healthcare community, we appreciate you … we depend on you … and we will make every effort to keep you informed and work with you to protect life and health before, during and after an event.”
Making Geriatrics, continued from page 19 working right now and the way of reimbursement, you’re not being paid to make a patient well. You’re paid to provide certain services. And many things that need to be done aren’t strictly medical. There’s coordination with long term services and supports and social issues and all sorts of things.” For example, on a recent clinic day, Brummel-Smith spent an hour with the wife and daughter of a geriatric patient who was too demented to understand his condition. “We wanted time to have an in-depth discussion about care planning,” he said. “I couldn’t bill for that because under Medicare rules, you can only bill for the patient’s care if the patient is there. But we were doing deep patient care planning that was very emotionally difficult, and it’s going to lead not only to a very good outcome as he nears the end of his life, but also it’ll help save CMS a lot of money for unnecessary care he wouldn’t want in the first place. There’s no way I could bill for that.” The PACE Elderplace Program in Oregon, which Brummel-Smith led before relocating to Florida, used a global-capitated model he calls “the ultimate model for reimbursement.” “If the capitation is fair – and that doesn’t mean exorbitant or skimpy – then you can appropriately care for the patients, and let the geriatric team and the patient memphismedicalnews
decide the right treatment rather than having insurance companies make the decisions,” he said. “We were free from all billing constraints, and we knew we had a certain amount of money to care for all our participants. We had quality measures to meet – some were patient-generated – so we were doing things they wanted, not just what we thought was good for them. It really was the perfect way to practice medicine.” Overall, there’s an upside to the gap of supply and demand of geriatricians. Even though geriatrics is labeled for patients over the age of 65, most seniors up to age 74 are relatively healthy and don’t need a geriatrician, Brummel-Smith said. “The perfect patients for a geriatrician are those above age 75, and especially those with multiple chronic conditions and longterm care needs, such as dementia, and the kinds of problems that are very difficult for internists and family physicians to take care of in a standard 15-minute visit,” he said, pointing out the American Geriatric Society considers the specialty both a primary care and consultation model. “We manage primary care for that population of complex and frail elders, and consultations to other physicians for the ‘younger’ old people,” he explained, “and for older people who are generally receiving good care from their primary care provider.”
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Stephen Klasko sets model for academic medical centers in an age of reform and austerity By LYNNE JETER
TAMPA, Fla. – In less than a decade, Stephen Klasko, MD, has transformed the medical school at the University of South Florida into an institution – USF Health – with unique partnerships, innovative collaborations, aggressive planning, and clearly outside-the-box Dr. Stephen thinking. Klasko This month, Klasko is leaving USF Health to lead Thomas Jefferson University and the TJUH System in his hometown of Philadelphia, Penn., the first person selected to head both institutions. He laid the groundwork for turning Tampa Bay – the home of USF Health – into a true medical destination. “We obviously have a great faculty and staff. But there’s also something more,” said Klasko, dean of the USF Morsani College of Medicine and CEO of USF Health. “In most places, a president and board really try to micromanage health sciences. (USF CEO) Judy Genshaft (PhD) and our board promised when I came here in 2004 from Philly they were going to give me the keys to create the medical school and health sciences center of the future. They fulfilled that promise. We’ve taken some calculated risks and done some things statewide even with local pressure.”
When Klasko joined USF, the university had four separate colleges. Four or five deans had passed through the doors in a decade. Klasko was immediately challenged with budget cuts. Since 2004, the medical school has lost 43 percent of its state funding, while four new medical schools have opened in Florida. “The reason I was able to do so much was because our supportive team didn’t back down the first time somebody didn’t like what we did,” explained Klasko. “Health is different than other academics. Having a president and board that wanted USF Health to be the best, the most creative and innovative institution made it easier for me to get things done.” In 2012, Klasko brought in Steve Liggett, MD, a pioneer in the emerging field of personalized medicine, to direct the newly created USF Health Personalized Medicine Institute. Then he helped craft an innovative, public-private strategic alliance with Florida Hospital to boost the quality of patient-centered care and improve outcomes in cardiology, breast health, neuroscience and surgical oncology. He also helped engineer a record gift – $37 million by Frank and Carol Morsani – whose name now precedes the new College of Medicine. To cap the year, he opened the nation’s first-of-its-kind Center for Advanced Medical Learning and Simulation (CAMLS). “We cannot transform this whole healthcare system, reduce admissions, create better quality, and have less mistakes
without the ability, like the airline taught us, to simulate those models, not just technically, but also from a teamwork prospective,” said Klasko about CAMLS. CBS “Sunday Morning’s” Charles Osgood called the training a “stress test simulating real life-and-death circumstances” for emerging surgeons. And that list doesn’t include perhaps USF Health’s greatest triumph via its partnership with The Villages, the nation’s first community-led, primary care-driven Accountable Care Organization (ACO) for Medicare Advantage patients. “It’s also probably the nation’s first true university-community partnership,” said Klasko, adding that 40 family doctors will partner with USF as exclusive specialists. At press time, 31 family doctors had been hired. Earlier this year, USF Health contracted with United Healthcare to manage the insurance product. “The Villages has received national attention, and we’ve even had venture capitalists come see how we’re going to serve 90,000 people,” he said. “If we save $3 million by providing healthcare more efficiently and effectively, $1 million will go back to the insurance company, $1 million will go back to USF, and $1 million will go back to the community. It’s a reinvestment in the local healthcare community that everyone can see. It’s very, very exciting.” Also, Klasko generated $2 million from Hillsborough County for the USF Health Byrd Alzheimer’s Institute. The
state has earmarked $20 million toward the USF Health Heart Institute. With the Moffitt Cancer Center, a teaching affiliate of USF, USF Health has the only oncampus, NCI-designated Comprehensive Cancer Center based in Florida. “There’s probably no place in the country that has that concentration,” he said. Remarkably, Klasko brought these initiatives to fruition during a time of economic sluggishness and incredible turmoil in the healthcare industry. “While everyone else was fighting the Affordable Care Act, we’ve taken another approach,” he said. “We’ve asked ourselves: What can we do now? Each of those accomplishments wasn’t happenstance. For example, we think it’s ridiculous that we still accept medical students based on their science GPA, MCAT scores, and ability to memorize organic chemistry formulas. We have a program now where we’re choosing students based on emotional intelligence. We think 10 years from now, it’ll be obvious that if you have a robotic surgeon, he’ll be component. If you have a doctor, he can communicate well. Today, that’s not the case. So we built CAMLS.” Nationwide over the next decade, Klasko predicts more partnerships will emerge – probably some surprising ones – between universities and communities. “It’s obvious that university higherups will no longer be able to sit in their ivory towers and hope that communities will send all their patients to them and charge whatever they want,” he said. “People will be rewarded with better care, not more or less care.” Changes in medical care via personalized medicine are already taking hold, said Klasko. “For example, we’re already changing cardiology treatments based on genomics,” he said. “This gets back to where everything comes together. At The Villages, our goal within 18 months is that all 90,000 residents will be on a common electronic health record, along with their history, physical and genetic data. For example, Steve (Liggett) has just done a polymorphism study about people at risk for Alzheimer’s. We’ll go the Villages and do an analysis of all 90,000 people who are all normal but have that genetic combination.” Klasko attributes USF Health’s philanthropic successes, such as the $37 million gift to establish the Morsani College of Medicine, and the Morsanis’ additional contribution of $2 million to create the Klasko Institute for an Optimistic Future in Healthcare, to “an optimistic approach during a challenging time.” “Some have complained that it’s not like it was before. Guess what? It wasn’t that great before! Things are better. We’ve got to stop whining. We can’t count on the government to solve our problems,” he said.
GrandRounds Methodist Hospital – Olive Branch Begins Accepting Patients Methodist Healthcare Olive Branch Hospital held its grand opening ceremony for the public August 21. The five-story 100-bed hospital began taking patients at 7 a.m. on Monday, August 26. They treated 25 patients the first day and admitted one. Routine complaints were abdominal pain, leg pain, syncope and bad headache. In two more serious cases, there was one patient from an auto accident and another with a heart attack who was stabilized and air-lifted to Methodist University Hospital. From design to build, Methodist Olive Branch Hospital took just 23 months, with 16 of those devoted to construction. It is the first newly licensed hospital to open in the state in 25 years. Methodist Olive Branch will grow to become a fullservice community hospital, offering several specialties—general and minimally invasive surgery, orthopedics, maternity, cardiology and cancer care, among others. Emergency services, lab and imaging were available upon opening, with other services to follow soon as patient volume grows. The state-of-the-art hospital drew nearly 1,500 attendees for the opening event which included remarks from Miss. Governor Phil Bryant, U.S. Senator Roger Wicker and Congressman Alan Nunnelee. Also speaking were David Baytos; Gary Shorb, chief executive officer of Methodist Le Bonheur Healthcare; Olive Branch Mayor Scott Phillips; former Olive Branch Mayor Sam Rikard; and Angie Brazil, representing the Methodist Olive Branch Family Partner Council. Rev. Bobby Baker, director of faith and community partnerships offered the opening prayer and Rev. Harry Durbin, Methodist Healthcare interim senior vice president of faith and health blessed the facility. The Olive Branch High School band provided music, with Tommy Woods, Methodist Healthcare board member and former State Representative, singing the national anthem. The hospital has been designed to meet energy efficiency and sustainability standards and will be the first LEED(Leadership in Energy and Environmental Design) certified hospital in Mississippi. The hospital is built to meet the LEED 2009 standard for healthcare set by the U.S. Green Building Council and will be one of only a handful of hospitals in the country to achieve the standard. Designed with input from patients and families, the hospital was truly a labor of love, in keeping with the hospital’s Patient- and Family-Centered Care culture. Each of Methodist’s hospitals has a council made up of former patients or their family members to ensure patients and families are active in their care, are engaged as integral members of the healthcare team and have a voice that is heard and are involved in making decisions about their care. The Methodist Olive Branch Family Partners Council was highly engaged in the design of the hospital, making choices about décor, color pallets…even the angle of the patient memphismedicalnews
beds to ensure they can enjoy the views and interact with visitors without straining. In a ranking completed by location analysis company Gadberry Group for Businessweek.com, the Olive Branch area is not only the fastest-growing town in Mississippi, but the fastest growing city in the U.S. The ranking is based on such factors as growth in the number of households within city limits and surrounding areas over the decade and from 2009 to 2010, plus average length of residency and average household income.
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Baptist Memorial president emeritus dies Joseph H. Powell, president and CEO of Baptist Memorial Health Care from 1980-1994, has passed away. He was 86. A native of Etowah, Tenn., he received a bachelor’s degree in business administration from the University of Tennessee, Joseph H. Knoxville and a master’s Powell degree in healthcare administration from the University of Minnesota. Powell began his career with Baptist as an administrative resident in 1954. He held a variety of positions throughout his 40-year professional Baptist career. He developed Baptist Memorial HospitalEast − now known as Baptist Memorial Hospital-Memphis − in the late 1970s, and in 1980, Powell became president of Baptist Memorial Hospital. The following year, he oversaw the creation of the Baptist Memorial Health Care system. During his tenure as president, which ended in 1994, Baptist experienced unprecedented expansion from two hospitals to a health care system with 32 health carerelated entities, about half of which were hospitals serving West Tennessee, North Mississippi and East Arkansas. Powell was also responsible for the planning for Baptist College of Health Sciences and other labs and services. After his retirement in 1994, Powell continued his relationship with Baptist by acting as president emeritus and senior consultant for the Baptist Memorial Health Care System, a position he held for the rest of his life. Powell also was instrumental in the formation of the Baptist Memorial Health Care Foundation, the charitable arm of the Baptist system, which provides each Baptist facility with resources to purchase new technology, implement innovative programs and enhance patient care. Powell received numerous commendations throughout his career, including the President’s Award and the Distinguished Service Award from THA, the L.M. Graves Memorial Health Award for Outstanding Achievement in Community Health, and the L. Palmer Brown Silver Hope Award from the National Multiple Sclerosis Society. He was also awarded an honorary doctorate of humanics from Union University in Jackson, Tenn. Powell is survived by his wife, Ann, three daughters and four grandchildren.
Saint Francis Hospital – Bartlett Receives Get With The Guidelines Gold Plus Quality Achievement Award Saint Francis Hospital-Bartlett has received the Get With The Guidelines®Heart Failure Gold Plus Quality Achievement Award from the American Heart Association. Get With The Guidelines–Heart Failure helps Saint Francis Hospital-Bartlett’s staff develop and implement acute and secondary prevention guideline processes to improve patient care and outcomes. The program provides hospitals
with a web-based patient management tool, best practice discharge protocols and standing orders, along with a robust registry and real-time benchmarking capabilities to track performance. The quick and efficient use of guideline procedures can improve the quality of care for heart failure patients, save lives and ultimately, reduce healthcare costs by lowering the recurrence of heart attacks. Following Get With The Guidelines– Heart Failure treatment guidelines, heart failure patients are started on aggressive risk-reduction therapies if needed, including cholesterol-lowering drugs, betablockers, ACE inhibitors, aspirin, diuretics and anticoagulants while in the hospital. Before discharge, they also receive education on managing their heart failure and overall health, including lifestyle modifications and follow-up care. Hospitals must adhere to these measures at a set level for a designated period of time to be eligible for the achievement awards.
Amgen And Medtronic Enter Agreement To Promote Prolia® (Denosumab) For Postmenopausal Women Amgen and Medtronic today announced an agreement under which representatives in Medtronic’s Interventional Spine division will promote Prolia® (denosumab) to spine specialists in the United States (U.S.), for use in postmenopausal women with osteoporosis (PMO) at high risk for fracture. Terms of the strategic partnership are set for three years. Medtronic sales representatives will begin promoting Prolia to spine physicians treating patients who have a history of osteoporotic fracture no later than July 31. Financial terms of this agreement are not being disclosed. It is estimated that one in two women over the age of 50 will have a fracture related to osteoporosis in their lifetime. Studies also show that only 24 percent of women who suffered an osteoporotic fracture received treatment during the following year.
New and Unique Option for Treatment in Memphis Area Results Physiotherapy, a physical therapy company based out of Nashville, Tenn., has launched its Specialty Clinic, specifically for the treatment of male and female pelvic pain, urinary and fecal incontinence, pre and post pregnancy conditions, bowel and bladder related issues and pain associated with sexual intercourse. The clinic will offer conservative treatment with a focus on ‘hands-on’ physical therapy or orthopedic manual therapy. Sara Lynn Johnson, PT, MS, MPT, ATC/L, CSCS and Dana Davis, PT, DPT, COMT, licensed physical therapists with advanced training in women and men’s pelvic health conditions, currently staff the clinic. The Nashville-based company, which currently operates 47 clinics across Tennessee, Alabama, North Carolina, Kentucky and North Mississippi, has identified a need for a specialty clinic of this nature—the first of its kind—in the Memphis market. memphismedicalnews
GrandRounds UT Medical Group Names Chuck Woeppel CEO Charles “Chuck” Woeppel has been named chief executive officer for UT Medical Group, Inc. He has been the organization’s chief operating officer since 2012 and will maintain those responsibilities, in addition to his new leadership role. He succeeds Dr. J. Chuck Woeppel Lacey Smith, who stepped down to focus on his clinical gastroenterology practice and his academic duties as professor of medicine at the University of Tennessee Health Science Center. Woeppel has more than 25 years of experience in managing academic and private practice physician groups and other health care organizations. He was chief executive officer for St. Theresa Medical Complex in Louisiana, where his responsibilities included overseeing construction of a long-term acute care hospital and merging the previous facility with the new hospital. As executive director for Meharry Medical Group at Nashville’s Meharry Medical College, he led the transition from a decentralized practice plan to a centralized practice plan. He also served as chief operating officer for the University of Virginia Health Services Foundation, an academic group practice of more than 750 physicians. A graduate of Canisius College in Buffalo, New York, Woeppel earned a master’s degree in healthcare administration from Xavier University. He is a member of the Medical Group Management Association and the American College of Healthcare Administrators.
Sutherland Cardiologist Named Commander of Army Reserves Health Unit Matthew Smolin, M.D., a cardiologist with Sutherland Cardiology Clinic, was chosen to be the commander of the 8th Battalion 4th Brigade (Health Services) of the 100th Division for the Army Reserves. Smolin said he is excited about the opportunity Dr. Matthew and looks forward to the Smolin challenges it presents. Dr. Smolin is responsible for ensuring the
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Memphis Jewish Home & Rehab Receives National Accreditation And Award Memphis Jewish Home & Rehab (MJHR) has received accreditation for 2013 as a skilled nursing facility actively performing Quality Assurance and Performance Improvement activities and was also recently awarded the Providigm Embracing Quality Award for 2013 for exceptional achievement in Customer Satisfaction. The accreditation, presented by independent accreditor, Providigm, LLC, demonstrates that the facility is continually assessing residents’ quality of life with regard to concerns such as pain, dignity, respect for resident choice, and quality of care problems such as whether there are enough staff to meet resident needs, weight loss, infections, rehabilitation following acute injury or illness, and prevention of readmissions to hospital. Unlike other such rating systems, the Providigm QAPI Accreditation is based on actions that Nursing Centers take to identify and correct quality problems. The methodology of QAPI is widely used in various health care settings, and is becoming a major focus of Nursing Home Regulation. With only 285 facilities receiving awards in 2013, the Providigm Embracing Quality Award puts MJHR in an elite group of skilled nursing facilities. “The Providigm Embracing Quality Award program recognizes the highest performers in three categories,” states Barbara Baylis, Accreditation Program Director at Providigm. “Skilled nursing facilities are recognized for outstanding survey performance, preventing readmissions to hospitals, and for superior levels of customer satisfaction. The 2013 Providigm Embracing Quality Award winners are truly the cream of the crop nursing centers.” Skilled nursing facilities were only eligible to win a 2013 Embracing Quality Award if they achieved standards for Quality Assurance and Performance Improvement (QAPI) as required by Providigm’s National Accreditation for QAPI. These standards ensure that facilities are assessing quality against the full federal
regulation at an ongoing rate, encompassing a substantial proportion of their residents, and correcting identified issues. To learn more about the research that contributed to the development of these standards, please visit www.providigm.com/recognition.
Paul Bryant Hill, MD, Geriatric Psychiatrist, Added to Delta Medical Center Staff Delta Medical Center proudly announces the addition of Dr. Paul Bryant Hill to its medical staff. Dr. Hill is certified by the Board of Psychiatry and Neurology, in Psychiatry, Geriatric Psychiatry and Psychomatic Medicine. Dr. Hill has practiced psychiatry for 20 years in Dr. Paul Bryant Hill the Memphis area. He received his medical degree from the University of Tennessee Health Sciences Center in Memphis in 1985. He completed his psychiatric residency at John Hopkins Hospital, Department of Psychiatry. A native Memphian, he graduated from Evangelical Christian School and completed undergraduate training at the University of Memphis in 1981. We are pleased that Dr. Hill is bringing his clinical experience and leadership in the field of Geriatric Psychiatry to the Delta Medical Center as it expands its medical/psychiatric treatment options for
older adult psychiatric patients. Dr. Hill will serve as Medical Director of the Delta Medical Center Geriatric Partial Hospital Program where he will offer psychiatric evaluations, therapy and medication management for older adults. Additionally, he will be available to provide consultation and training to area health and mental health professionals and education for caregivers.
SVMIC Celebrates 30 Years Of Excellence State Volunteer Mutual Insurance Company (SVMIC) has again received an “A” (Excellent) financial strength rating from A.M. Best Company. This marks the 30th consecutive year SVMIC has maintained an “A” or better rating. No other physician-owned liability insurer has earned a higher rating for as many consecutive years. The A.M. Best Company is the oldest, most experienced rating agency in the world and has been reporting on the financial condition of insurance companies since 1899. The Best’s Financial Strength Rating is an independent opinion of an insurer’s financial strength and ability to meet its insurance obligations. Founded in 1976, SVMIC is one of the largest and most successful insurance companies of its kind, insuring more than 14,000 physicians in Tennessee, Arkansas, Virginia, Kentucky, Georgia, Alabama and Mississippi.
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GrandRounds UTHSC Officially Names First Dermatology Department the Kaplan-Amonette Department of Dermatology The University of Tennessee Health Science Center (UTHSC) Dermatology Department in the College of Medicine has been officially named the KaplanAmonette Department of Dermatology, in honor of Robert Kaplan, MD, and Rex Amonette, MD. Drs. Dr. Robert Kaplan and Amonette, Kaplan both UTHSC dermatology alumni, provided the ongoing support and participation that made the new department possible. Dr. Kaplan practices in Memphis at Kaplan and Dr. Rex Kaplan Dermatology. He Amonette holds multiple leadership positions within UTHSC, including serving on the UT Foundation’s board of directors and the UTHSC College of Medicine Alumni Council. Dr. Kaplan’s recent gift to the UTHSC Department of Dermatology, a major multi-year commitment, will have a tremendous impact on the expansion of the department. Dr. Amonette served as the first interim chair of the Department of Dermatology from its creation in November 2012 until May 1, when Kathryn Schwarzenberger, MD, was appointed chair of the department. Dr. Amonette is founder of the Memphis Dermatology Clinic, and was an early pioneer of the Mohs Micrographic Surgery procedure for skin cancer treatment. He was only the second fellowshiptrained doctor in the nation to begin the practice. Dr. Amonette has been president of numerous organizations such as the Memphis Dermatological Society, the Tennessee Dermatological Society, the American Academy of Dermatology, and the
American College of Mohs Micrographic Surgery and Cutaneous Oncology. He has served on numerous boards and hospital staffs, and has taught throughout most of his career.
UTHSC Leaders Meet with Legislators to Discuss UTHSC Economic Impact, Campus Master Plan and Possible Joint Venture with the MED Leaders of the University of Tennessee Health Science Center (UTHSC) hosted members of the Memphis City Council, Shelby County Commission and state legislature to update them on the economic impact of UTHSC on the community. The group also discussed the UTHSC campus master plan, which includes demolition of five buildings, construction of several new research and education structures, and renovation of outdated, existing facilities. UTHSC Chancellor Steve Schwab, MD, and Executive Vice Chancellor and Chief Operations Officer Ken Brown, JD, MPA, PhD, welcomed the public officials, including City Council Chairman Edmund Ford Jr., County Commission Chairman James Harvey and State Representative Joe Towns. Brown took them on a tour of the campus, noting that he is committed to telling “the local constituency” more about what UTHSC does, especially the economic impact it has on the community. As extensive as that role is today – with UTHSC having an almost $2 billion economic impact on the Memphis economy every year – that influence will become even greater, Brown explained, with multiple renovation and construction projects slated for the next few years. One such project being seriously discussed is a roughly $200 million Women and Infants health pavilion, which would be a cooperative effort with the MED. Another will be the renovation of the Mooney building and library, a structure situated at the historic core of the UTHSC
campus, which has been vacant for the past 20 years. UTHSC-trained physicians, nurses, pharmacists, dentists and allied health professionals comprise the lion’s share of the health care workforce in the state. UTHSC health care professionals provide more than a million days of hospital care across the state every year and more than two million outpatient visits.
West Cancer Center Introduces Radium 223, Xofigo®, Novel Treatment for Prostate Cancer The West Cancer Center in conjunction with the nuclear medicine department of Methodist Healthcare has announced the introduction of Xofigo® (radium 223 dichloride) for the treatment of select patients with advanced prostate cancer. In May, the U.S. Food and Drug Administration (FDA) approved Xofigo® (radium Ra 223 dichloride) for the treatment of patients with bone metastasis who are castration-resistant. Xofigo is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival and delay in time to first symptomatic skeletal event (SSE) compared to placebo. The new treatment emits low levels of alpha particle radiation, sparing and exposing little surrounding tissue due to small depth of penetration. Xofigo has the advantages of enabling a better quality of life, pain relief, prolonged survival and less side effects for the appropriate men with castration resistant prostate cancer. According to Brad Somer, MD, Medical Oncologist with West Cancer Center, the new treatment adds to the current armamentarium of hormonal, chemotherapeutic and immunotherapy options available to men in this category. The West Cancer Center has a long history of bringing cuttingedge cancer treatments and research strategies to the region.
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