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Lorraine Charles, MD ON ROUNDS

Asthma APGAR Tool Improves Management in Primary Care Setting A study published last month in the Annals of Family Medicine assessing the efficacy of the Asthma APGAR tool in the primary care setting found usage improved asthma control and decreased asthma-related hospital admissions and emergency room visits ... 6

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Cumberland Pharmaceuticals Launches Oncology Division By CINDY SANDERS

See a need. Fill a need. This call to action has been a guiding principle for Cumberland Pharmaceuticals since We’ve had the company was founded in 1999 and has led to the company’s newest venture. “We’re announca very active ing the formation of a new division just to focus development & on oncology,” said Chairman and CEO A.J. Kazimi. acquisition program, “Oncology is a particularly rewarding and and we’re on the valuable field,” he continued. “Many of us are touched by it either personally or through family hunt for more. and friends so it’s exciting to start to get involved — A.J. Kazimi and help these patients.” The oncology division will be the company’s third vertical where Cumberland Pharmaceuticals establishes deep expertise, joining the acute care and gastroenterology divisions. The announcement builds off the recent U.S. launches of Cumberland’s two FDA-approved oncology support drugs of Ethyol® and Totect®.

Strategic Growth

Starting with two employees, Cumberland has now grown to more than (CONTINUED ON PAGE 7)

It’s a Wrap

Reflections on the Latest LHC Delegation to D.C. Leadership Health Care (LHC) – an initiative of the Nashville Health Care Council for emerging industry leaders – wrapped up the group’s annual pilgrimage to Washington, D.C. on March 13 ... 8

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All In: Conversations on Health in Nashville By CINDY SANDERS

and whether or not a person’s zip code might be more important than their genetic code. Last month, NashvilleHealth and the Metro Despite spending the most money on healthcare, Public Health Department launched All In: Conversalife expectancy in the United States falls behind many tions on Health in Nashville, a new speaker series devoted other developed and developing nations. The World to addressing some of the city’s most pressing health Factbook 2017, produced by the Central Intelligence issues. Agency, ranks the United States 43rd out of 224 counBringing together diverse stakeholders at the Lentz tries for life expectancy at birth. “Countries with the Public Health Center, the inaugural event kicked off biggest income inequities have lower life expectancies with speaker Tony Iton, MD, JD, MPH, senior vice overall,” said Iton. “In the end, our biggest health risk president of Healthy Communities at The California might be inequality.” Endowment with oversight of a multimillion-dollar A native of Canada, Iton moved to the United Dr. Tony Iton statewide commitment to advance policies and partStates in the mid-1980s for medical school at Johns nerships to improve health across California. Iton discussed the corHopkins. Touring East Baltimore for the first time was shocking, he (CONTINUED ON PAGE 4) relation and impact of where an individual lives on health outcomes

For more topic-driven information by subject matter experts, check out our blog:




Caring for Generations Lorraine Charles Bridges Past, Future through Medicine By MELANIE KILGORE-HILL

Lorraine Charles, MD, has a passion for the underserved. A family practice physician at Saint Thomas Medical Partners, Charles is a Brooklyn native born to Haitian parents, and she remains deeply rooted in the culture and welfare of her family’s native home.

From New York to Nashville

Charles received her Bachelor of Arts degree from Long Island’s Adelphi University before moving to Nashville to attend Meharry Medical College. She said the school’s commitment to health disparities and the underserved mirrored her own ideals surrounding medicine. “Meharry’s culture focused on the underserved and those with limited access to healthcare,” Charles said. “Growing up in Brooklyn, I had seen similar environments and knew I wanted to be a part of eliminating health disparities.” Charles completed a residency in family medicine at the University Health Science Center in Tyler, Texas, before returning to Nashville for her current role.

Finding Her Place

in a position to further educate and help protect them in the long run.”

The oldest of four children, Charles helped as a caregiver to her younger siblings and her Creole-speaking grandparents, whom she often accompanied to doctors’ appointments. By the time she was a teenager, Charles was already well versed in healthcare and the challenges facing the elderly. “I was their translator but also helped them learn to take medications and make appointments,” she said. “I loved caring for the elderly, and that experience gave me the desire to be in the trenches, working at both ends of the spectrum with the young and the old.” Today, she enjoys practicing the full scope of primary care and loves seeing everyone in the family from granddaughter to grandmother.

Serving the Less Fortunate

A Heart for Haiti

In 2008, Charles went on her first medical mission trip to Haiti. She was struck both by the challenges and the innovation common to providers working with very limited resources. It was here that she met her future husband, Mario,

and returned for medical missions in 2012 and 2015. In 2014, Charles was named ‘Mrs. Haiti International,’ and used her platform to educate Haitians on pre- and postnatal care, as well as safer birth practices.

A Champion for Women’s Health

At home in Nashville, Charles continues her crusade for women’s health issues and preventative care, encouraging patients to follow up on physicals, pap smears, mammograms and bone density tests. “I see all ages of women – from those in their teens with changing needs to those having children and in their final years,” she said. “Women are often the center of their families and the ones caring for everyone else, so my goal is to keep them well for as long as possible.” Working with multiple generations has given Charles unique insight into the changing attitudes and education surrounding a woman’s care. “I see a shift in young people taking charge of their health,” she said. “They know they need to stay ahead of the game, and I like being

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Bonus Editorial Go online to NashvilleMedicalNews. com for additional editorial in April, including: • Extended version of “Asthma APGAR Tool Improves Management in Primary Care Setting” • Addressing Physician Burnout • April Grand Rounds

She also continues her work with the underserved, always seeking new ways to help those on limited funds or with no access to primary care. Since symptoms from high blood pressure and diabetes often go unnoticed, Charles said patients often believe they’re completely healthy until they visit the doctor. “Some things are there whether we acknowledge them or not, and I try to teach patients that coming to the doctor helps to get a handle on that, rather than causing it,” she said. Another struggle among at-risk or minority populations is a misunderstanding of diagnoses and treatment plans. “A lot of these patients don’t really understand why a certain drug is needed, so I spend a little more time explaining why and the risks of not taking their medications,” she said. “They need to understand that although a problem isn’t bad right now, we’re trying to avoid long-term complications to reduce those risks.” When she’s not in the office, Charles spends her free time traveling, practicing yoga, salsa dancing and singing in her church choir. In 2016, Charles embarked on yet another adventure when she and Mario welcomed their daughter, Leilani.

Blog Log The Nashville Medical News Blog features additional insights and information from a cross-section of industry leaders. The blog can be accessed directly through NashvilleMedicalNews.Blog or from the homepage of the main website.

NEW IN APRIL: Jordan Asher, MD, chief clinical officer of Ascension Care Management, has penned a piece looking at the question of whether MIPS might lead to care innovation. J. Taylor Chenery, a member at Bass, Berry & Sims, breaks down recent communications relating to the DOJ’s use of federal agency guidance documents in affirmative civil enforcement cases, as well as the potential impact on government enforcement actions in the healthcare industry.    Kinika Young, director of Children’s Health for the Tennessee Justice Center, will share information on the new Insure Our Kids statewide campaign, which launched in March.



A Lack of Access to Specialty Care A Physician’s Appeal for Help Serving the Underserved By CYNTHIA YELDELL ANDERSON

When Concepcion “Conchita” Martinez, MD, signed on as lead doctor at Total Health Medical and Dental in Antioch, she hoped to replicate the success at Medicos that operated seven days per week serving the Hispanic community, which at one time had up to 20,000 patient visits per year. Dr. Conchita Martinez “That’s what I want Total Health to be … comprehensive, affordable care with or without insurance, ” said Martinez, noting that Total Health has doctors, nurses and support staff who all speak Spanish. Since joining Total Health last October, Martinez said business has been good, but she has noticed her biggest challenge is finding specialists for patient referrals. As a primary care physician, Martinez said she can treat 90 percent of medical issues that come through the door, including prenatal care, ultrasounds, vaccines, X-rays, well child visits, gynecological procedures, minor surgeries and more. However, there are times when Martinez has to refer patients to a specialist, and many patients wind up with long waits. During

this period, Martinez said patients often see their conditions worsen. “Specialists have been traditionally hard to get into,” Martinez said. “The reason why is because of lack of insurance, and insurance that is not accepted by many specialty offices.” Total Health is a part of Meharry Medical Group, which does offer specialty care, and Meharry specialists do see Martinez’s patients eventually. However Martinez said there is a real need for more specialists that accept uninsured and underinsured patients in the Nashville area and around the country. “The specialists at Meharry are excellent, but there are only so many of them,” Martinez said. “There are specialty areas that are underrepresented such as urology, hematology, oncology, rheumatology, nutrition, plastic surgery, and others.” She added it could take three months or longer for her patients to get in to see a specialist as she refers throughout Nashville. “Sometimes I get on the phone and call the doctor and ask them to see my patients,” Martinez said. “The last patient I had that needed a vasectomy had to wait six months. It’s hard to get patients in. The specialists are overwhelmed.” Martinez said some patients become so frustrated that they stop pursuing specialty treatment. Instead, they let their condition worsen until they ultimately end

up in the emergency room, which leads to poorer health outcomes and more costs for the patients and healthcare system, she pointed out. “That cost is huge, and it’s not optimal care,” Martinez said, adding preventative services like treatment for depression or mental illness also are often missed when patients go to the ER for treatment. “The emergency room is not a good way to take care of yourself. The emergency room is not interested in your diet or your day-today health. That’s not their purpose.” Millard Collins, MD, chairman of the Department of Family and Community Medicine at Meharry Medical College, said the problem with access to care is not only impacting the uninsured, but he’s sees many working people with highdeductible insurance plans who are reluctant to go to the doctor because they can’t afford their deductible. He said this problem Dr. Millard Collins with access to care is not unique to Dr. Martinez or Meharry. “It’s a problem in Nashville and every city where there is a divide between rich and poor,” Collins said. “Meharry, since 1876, has always addressed issues

of health disparities. Nashville is a city that’s continuing to grow. The problem will only get worse as more people move into Nashville, so it’s best that we start to address it now.” Contributing to the problem, Collins said, is the fact that fewer doctors are business owners who have the autonomy to make decisions on their own. As solo practitioners disappear, he said, business managers make the decisions about which insurances and payment methods are accepted, and physicians often aren’t involved in the policy decision-making process. “It’s part of the corporatization of medicine,” said Collins. “There are some very good specialists in Nashville. When they are in a group with 20 or so other specialists, it’s not always their decision.” Collins said Meharry and Total Health see cash patients and will provide care to patients regardless of their insurance status. He offered a challenge to other area specialists to make a greater effort to be more accessible. “We want people to remember why they started this journey to be a physician,” Collins said. “We start medical school as idealists and get lost along the way. It’s our hope that if any specialists are willing to partner with us, they will contact the Meharry Medical Group.”

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All In: Conversations on Health in Nashville, continued from page 1 recalled. “I’d never seen anything like it in my life. To me, it looked like a war zone,” he said of the inner city. The children he saw there had a very different experience than he had growing up in Montreal. Iton said he felt like Canada, which has a strong social contract, really invested in its citizens. In his former position as director and county health officer for Alameda County Public Health Department, which includes San Francisco, Iton again saw that strong correlation between social strata and life expectancy. A self-described ‘data junkie,’ he looked at four variables among the county’s approximately 10,000 annual deaths – cause, address, age at death, and ethnicity. What he found was the difference in black and white life expectancy in the 1960s was about 2.3 years but had increased to 7.8 years by 2005. Overlaying the life expectancy map with a census poverty map, ‘death hot spots’ appeared. He was quick to note Alameda County isn’t an outlier. Some neighborhoods in Baltimore have a life expectancy in the high 50s compared to the national average of 78.6 years. “Everywhere we looked – everywhere – we found life expectancy differences of at least 12-15 years and in some cases up to 30 years,” he said of the contrast between those with resources and those without. In early 2005, Iton and his team created a scatter gram focused on poverty and life expectancy and monetized

the slope of the lines. “Every additional $12,500 in household income buys one year of life expectancy,” he noted. He added that chronic stress is probably a key differentiator. While everyone has stress, he noted, those with resources have options to counter stressors. There is a physiological difference between being ‘stressed’ and ‘stressed out,’ Iton said. Stress can increase cardiac output, available glucose, and enhance immune function. The hormone cascade in someone stressed out can lead to hypertension and cardiovascular disease, glucose intolerance and insulin resistance, and chronic infection and inflammation. In the traditional medical model, Iton said practitioners work downstream to try to change risk factors and behaviors – a $3 trillion enterprise he called “necessary but inadequate.” Instead, he continued, there is a growing argument for changing the upstream socio-ecological factors for more lasting change. Despite, the country’s large healthcare expenditure, outcomes still lag behind other nations. “We spend a lot and get relatively poor bang for the buck,” Iton pointed out. Interestingly, however, when researchers created a graph that combined health expenditures and social service expenditures, the United States no longer looks like the big spender. For every $1 other nations – with better health outcomes and life expectancies – spend on healthcare, they spend about $2 on

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social services. In America, that’s reversed with the nation investing about 55 cents in social services for every $1 spent on healthcare. “We don’t spend more than others … we just spend really, really badly,” said Iton. “We have our accent on the wrong syllable.” To change the story, Iton said you must first understand the narrative. He said it was intriguing to see how different people explained or defined poverty. In France, for example, those who were poor were most often described as ‘unlucky’ or ‘having faced misfortune.’ In the United States, the overarching theme was poor people are lazy and bring misfortune on themselves. “Those two narratives inform

different policy approaches,” he pointed out. So what could be done differently in America to begin to improve health and outcomes? Iton said there are three practical action items health departments and other stakeholders could take to begin to move the needle: • Align with people who build power. • Look at the dominant narrative and then think about opportunities to change that narrative. • Bring ‘the butcher, the baker, the candlestick maker’ to the table. “You’ve got to radically bust silos,” he concluded of working across disciplines to create sustainable change.

The Case for Corporate Social Responsibility Firestone Medical Missions Give Back to Second Home By CINDY SANDERS

Earlier this year, Firestone Natural Rubber Company LLC, a subsidiary of Bridgestone Americas, teamed up with Children’s Surgery International (CSI) to host a medical mission that has become an annual event in West Africa. Don Darden, director of After surgery Administrative Operations for Before surgery Firestone, splits his time between Nashville and Liberia, where the company see the individuals … that’s what’s really has a major operation. Darden noted Harimportant,” Darden stated. He noted that vey Firestone launched Firestone Liberia prior to surgery, some of the children have in 1926. Operating under a concession been unable to attend school. He added agreement with the Liberian government, there is still a lot of cultural superstition surthe Firestone campus is approximately 185 rounding cleft lip, which makes life difficult square miles in size, employees more than for those children and their families. 7,000, and is home to about 80,000 within Another key component of the the borders of the concession. In addition, annual medical mission is training for the explained Darden, “We have a 300-bed physicians on staff at Firestone’s Medical hospital and two clinics located on the Center at Duside. The hospital includes property.” three surgical theaters, labs and outpatient Since 2010, the company has partservices for adults and pediatrics. Darden nered with Minneapolis-based CSI to said CSI shares surgical techniques with extend healthcare services beyond the the Liberian medical team. “Their ultiFirestone concession population to bring mate mission is to work themselves out of much-needed specialty care at no cost to a job as they train the local surgeons,” he West African children in need. “We knew added. of the medical needs, but they (CSI) helped In the meantime, Darden said the amplify it and gave us a very structured next medical mission is already on the way to attack it,” explained Darden of the books for January 2019. The Firestone partnership. “It provided a way for us to team will begin the preparatory work this help out where there was such tremendous fall with pre-screening for potential cases need.” followed by onsite health screenings. The Darden said CSI typically brings sevlarge operation requires transportation and eral surgeons with expertise in urologic, housing for the young patients and families, facial and general surgery to work alongas well, since the majority of the cases come side the local medical team to help children from families without connection to the with cleft lips and palates, hernias and comcompany. Despite the months spent workplex urologic issues. ing on the mission each year, Darden said This year, the group performed 101 its simply part of the corporate culture that surgeries in just under 100 hours. “They begins at the top with Bridgestone. bring the expertise for lifesaving, lifeUltimately, Darden said, giving back changing surgeries,” said Darden. While to the community in West Africa in conit makes for very long days, he said the junction with CSI is simply the right thing outcomes couldn’t truly be measured in to do. “It’s been a great partnership and time or money. “The numbers are always certainly one where everybody is a winner, important when you do a mission, but to I believe.” nashvillemedicalnews


Building Bridges

Anthony Making a Difference with TDH By MELANIE KILGORE-HILL

Some people just seem born to make a difference. Such was the case for Monique Anthony, MPH, CHES, director of the Office of Minority Health and Disparities Elimination at the Tennessee Department of Health. Anthony took the helm as interim director July 2017 and was named to the permanent position in Monique Anthony December. Previously, she served as the office’s director of capacity building since August 2016. “Monique has dedicated her career to improving population health and is passionate about patient advocacy, building community engagement and reducing health disparities,” said TDH Commissioner John Dreyzehner, MD, MPH. “She has extensive experience in cultivating partnerships and innovation and has already proven to be a dedicated advocate for vulnerable and disadvantaged populations in her role as acting director, so I am especially pleased she will take on this important leadership role going forward.”

A Heart for Helping

“I’ve always been interested in medicine and health … and in helping people,” Anthony said. “At a basic level, I’ve always wanted to feel like I’m contributing to the success of someone, whether that’s an individual, an organization or a community.” A native of Nashville, Anthony followed her lifelong passion for healthcare, earning her bachelor’s degree in biology from Spelman College in Atlanta. While working in a hospital, she encountered colleagues who also held Master’s in Public Health degrees. “Seeing that sparked my interest, so I began to do my own

research in areas outside of direct patient care, to see what the other side of health means,” she said. That curiosity ultimately led Anthony to Johnson City, where she earned her own MPH degree from East Tennessee State University. Prior to joining the Tennessee Department of Health, Anthony served as program coordinator at Meharry Medical College, managing the SECURE/Gulf Coast Transdisciplinary Research Recovery Center for Community Health grant. The grant brought together a consortium of seven medical and public health institutions to address challenges affecting the health of those living in Gulf Coast communities prone to disasters and environmental contamination. A certified health education specialist, she is a member of the Tennessee Public Health Association, the Meharry Medical College Institutional Biosafety Committee and the Tennessee Cancer Coalition, for which she serves as co-chair of the executive committee. Anthony is also a member of LEAD Tennessee Alliance 9 and remains active in community service with a number of organizations. 

A New Role

In her role as director of Minority Health and Disparities Elimination, Anthony provides administrative, financial and operational leadership and oversight for programming to reduce health disparities and improve overall health and well-being of minority populations, especially racial and ethnic minority populations across the state. Managing a budget of $1.1 million and five staff members, she facilitates and advocates for the development of policies, programs and services that appropriately respond to the cultural and diverse needs of Tennesseans. “When I accepted this position I was looking for a challenge and for growth opportunities,” Anthony said. “Stepping

into this level of work has definitely shifted my thought process and how I approach the work. A paradigm shift from individual community engagement to big picture systems change can provide greater impacts in moving the needle in disparities elimination.” As director, Anthony hopes to expand the department’s reach in educating the community around minority health and to promote her office as a resource equipped with tools to address health disparities. Anthony said health professionals, as well as the public, are often not familiar with the services and resources available through her office. To that end, she’s partnering with faith communities, academic institutions, coalitions, nonprofits, and other traditional and nontraditional partners statewide to help them reach underserved and minority populations. “We pride ourselves on providing technical assistance for our communities and bringing their voice to the state level,” Anthony said. “One of the things you learn quickly trying to address health concerns within a community is that you have to meet people where they are and not try to come in with your own assumptions of what they need. We’re looking at ways our office can be more effective at building capacity within the community by being that connector to resources.”

Building Bridges

Anthony hopes to create a niche cultivating relationships with people and partners in each community. “At the Tennessee Department of Health, we all strive to break out of our silos and work together collectively to address needs of the community,” she said. She hopes to further that effort by incorporating disparities into those ongoing conversations. But as any public health professional will tell you, building bridges starts with building trust. For many populations, that relationship has been corroded by a decades-old mistrust of any government organization. Building those bridges, said Anthony, is the only way to improve outcomes for underserved populations who may not have access to affordable care, who may not understand health practices that prevent illnesses, and to address early stages of disease. She also hopes to gain support from those who have contact with these communities on a daily basis. “Each of us, whether clinicians or other health professionals, are called to really listen to the person we are serving,” Anthony said. “Whether a patient, a concerned family or community member, we must dedicate the time needed to make each person feel valued and heard.”

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EC Launches Project Healthcare, Calls for Applications Last month, the Nashville Entrepreneur Center announced the launch of Project Healthcare Portfolio and opened the application process for participants in the program that leverages the full support of the EC’s expertise and network to accelerate success. The unique, healthcare-focused program takes the properties of a full accelerator and makes it available on-demand, year-round for enrolled entrepreneurs. Project Healthcare connects entrepreneurs with the EC network of startup and healthcare industry advisors, access to startup curriculum, networking partners and community support. The resources are delivered in a tailored manner that meets participants at their specific stage of development. The 2018 full program launch follows a successful pilot program in 2017. “The EC has always provided exceptional value to healthcare startups,” said EC CEO Michael Brody-Waite, who personally utilized the EC’s healthcare expertise for his previous startup InQuicker. “Project Healthcare Portfolio allows us to deliver that value to more entrepreneurs in a more sustainable way.” A number of industry leaders from across the healthcare sector have signed on to support the 2018 Project Healthcare program including HCA Healthcare, LifePoint Health, the Nashville Healthcare Council and Bass, Berry & Sims LLC. Project Healthcare Portfolio is open to North American entrepreneurs creating, launching or growing healthcare startups. While participants can work from anywhere, they must attend a minimum of four curated, Nashville-based events over the course of the program, which runs from July 2018 through July 2019. Those interested in participating the program should apply by June 8 through



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Primary Care Transformation a Priority for TennCare By MELANIE KILGORE-HILL

Five years after Gov. Bill Haslam introduced the state’s Health Care Innovation Initiative, efforts are in full swing. The plan was designed to revamp the way healthcare is paid for – moving from volume to value. The initiative’s three strategies included episodes of care, long-term services/supports and primary care transformation.

Primary Care Transformation

Primary Care Transformation focuses on the role of the primary care provider in promoting the delivery of preventive services and managing chronic illnesses over time. Since its inception, the initiative has developed an aligned model for Patient Centered Medical Homes, the first of its three initiatives. In 2017 TennCare’s three health plans launched a statewide-aligned PCMH program with 29 organizations.

Tennessee Health Link

The second component of the transformation initiative included a Tennessee Health Link for TennCare members with the highest behavioral health needs. TennCare has since worked closely with providers and TennCare’s three health plans to create a program to address the diverse needs of these members. A Health Link Technical Advisory

Group of Tennessee clinicians and practice administrators was convened in 2015 to develop recommendations in several areas of program design including quality measures, sources of value, and provider activity requirements. The design of Health Link was also influenced by federal Health Home requirements. The Health Link program began statewide on December 1, 2016.

Pharmacy Pilot Program

In February 2018, TennCare announced the launch of a new pilot program that will further support primary care transformation through a two-year medication therapy management pilot program. The MTM pilot focuses on providing the best therapeutic outcomes for individual TennCare members. Pharmacists participating in the pilot project will provide MTM services in PCMH and Tennessee Health Link settings to help TennCare members get the most benefit from their medications. TennCare officials said the goal of the MTM pilot is to work with members to actively manage their drug therapy by identifying, preventing and resolving medication-related problems. TennCare plans to study the impact of incorporating pharmacists into the extended care team during the pilot period. “Pharmacists play an integral role in our member’s health journey,” said

TennCare Chief Medical Officer Victor Wu, MD. “Engaging our members on how to use their medications and manage their diseases is essential to empowering them to take control of their Dr. Victor Wu own health. Integrating pharmacists with primary care and mental health providers in a collaborative care team approach can be highly impactful.”

Care Coordination Tool

In addition, Tennessee has developed a shared care coordination tool that allows providers participating in the PCMH and Tennessee Health Link programs to be more successful in the state’s new payment models. The tool has been designed to identify and track the closure of gaps in care linked to quality measures. It also allows providers to view their member panel and members’ risk scores to facilitate provider outreach to members with a higher likelihood of adverse health events. Additionally, the tool enable users to see when one of their attributed members has had an admission, discharge, transfer from a hospital, or ED visit and track follow-up actions. The Care Coordination Tool was rolled out to PCMH and Tennessee Health Link providers in February 2017.

Asthma APGAR Tool Improves Management in Primary Care Setting By CINDY SANDERS

A study published last month in the Annals of Family Medicine assessing the efficacy of the Asthma APGAR tool in the primary care setting found usage improved asthma control and decreased asthma-related hospital admissions and emergency room visits. Barbara Yawn, MD, MSc, FAAFP, lead author of the study from the Department of Research at Olmsted Medical Center in Rochester, Minn., said the pragmatic study enrolled 1,066 patients between the ages of five and 45 across 18 U.S. family medicine Dr. Barbara Yawn and pediatric practices to compare outcomes in patients with persistent asthma using the APGAR tool vs. usual care. “The reason we even worked on developing the APGAR tools is because we had seen that ACT – the Asthma Control Test – has been around 20 years, and it’s still not widely used,” Yawn said of the 6


APRIL 2018

impetus behind the research. While ACT creates a score, Yawn said a key issue for many providers was how to apply that score to the next steps. “It became clear to me we needed a tool that was more broadly based for primary care and was linked to suggestions for action,” she continued. The research team created the APGAR tool with six questions for patients assessing asthma control. The first three questions ask about asthma in relation to activities and persistence of symptoms during the day and night. The next question looks at triggers, followed by questions regarding asthma medications and response. Like ACT, APGAR creates a score. However, Yawn explained, the APGAR score is tied to a care algorithm with specific actions. “Anyone with a score of two or greater is out of control,” she explained, adding previous research indicated as many as 60 to 80 percent of asthma patients fall in this category. With the algorithm, providers have a stepwise process to address a range of potential issues impacting patient control. “If they’re having an acute exacerbation,

you have to deal with that immediately. Otherwise, before you just step up their medications, think about adherence, correct usage, triggers, etc. It helps you think through what you ought to look at,” Yawn said of the care algorithm. Participating patients were asked to complete both a baseline and 12-month questionnaire with 65 percent (692 patients) completing both for assessment of patient-reported outcomes. In addition, electronic health record data was available for 99.7 percent of participants (1,063 patients) to allow the team to evaluate practice outcomes. In the APGAR group, there was a 50 percent decrease in emergency room visits, hospitalizations and urgent care visits compared to the usual care cohort (10.6% v. 20.9%, P=.004). “We were very excited about that,” said Yawn. “It’s a big number.” There was also a statistically significant increase in patients with “in control” asthma in the APGAR group compared to the usual care cohort and an improvement in adherence to three or more asthma guideline elements for APGAR practices.


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April Grand Rounds Online



Cumberland Pharmaceuticals Launches Oncology Division, continued from page 1 100 team members across the country promoting and developing the biopharmaceutical company’s product lines. Kazimi noted Cumberland is coming off a strong year that saw 25 percent revenue growth in 2017. “In fact, we were the top-performing stock in the healthcare community here in Nashville,” he said. “We’re coming off a great year, and now the challenge is to continue that momentum.” To that end, Cumberland crafted a strategic growth plan several years ago with a commitment to adding at least one brand per year through acquisition or development. However, Kazimi stressed, product additions had to be intentional and targeted to fit the niche expertise central to the company’s mission of answering unmet needs. As pharmaceutical companies in America merged and became larger and larger, Kazimi said the focus shifted to blockbuster drugs to fuel growth. “We felt there was an opening to start a new company to get involved in brands – developing and commercializing – that maybe weren’t a match for those big boys but still very important to the doctors and nurses who provide them and especially to the patients who need them.” The company’s first product, Acetadote® (acetylcysteine), has become standard-of-care for the treatment of acetaminophen poisoning and is found in more than 3,000 hospitals across the country. Since then, another six products have made it to market. “We’ve added them one by one. Some we developed in-house, and others we actually went out and acquired and moved them here to Tennessee,” said Kazimi. “We’ve had a very active development and acquisition program, and we’re on the hunt for more,” he continued. That hunt has led Cumberland to oncology products. The company’s medical advisory board shared the growing need for supportive drugs as more and more patients are being diagnosed with cancer and surviving longer. “We heard that, and so our first two moves are with two brands that don’t cure cancer but help the patients as they go through their cancer treatments,” he explained. “The question is can you help them tolerate their treatment and help them with their quality of life after?”


In addition to the current FDAapproved uses, Kazimi said a number of physicians are successfully using Ethyol in prostate cancer patients to protect the intestine while a tumor is being radiated and in lung cancer patients to protect as much of the lung as possible.


Introduced late last year, Totect (dexrazoxane) is an emergency intervention for patients whose anthracycline chemotherapy agent leaks out of their blood vessels and circulates into surrounding tissue, which causes severe damage and serious complications. Totect limits the damage without the need for additional surgeries and procedures, allowing the patient to continue their cancer treatment. In clinical trials, Totect eliminated the need for surgery in 98 percent of patients with anthracycline extravasation. “It’s really almost like an antidote,” explained Kazimi. “It stops that poisoning and damage to your tissues that your chemotherapeutic agent can cause.” He added, “This is the only product approved for that problem.” Additionally, dexrazoxane has a popular off-label use as a cardioprotective agent that is often utilized for pediatric leukemia patients and increasingly for women with breast cancer as research

points to a raised risk of heart disease following cancer treatment. Although not approved for that indication, Kazimi said at the time they landed the U.S. rights to Totect as part of the strategic alliance with the Clinigen Group, there had been a national shortage of dexrazoxane. “The minute the FDA put it on their website that it was available, we were bombarded by children’s hospitals and major cancer centers from all over the country asking for emergency shipments because they needed it so their cancer patients could continue their treatments. That was a really rewarding and really exciting time.”

Next Steps

“We’ve got a pretty robust pipeline today of products in development to address patient conditions where there’s nothing available to help them,” Kazimi said. “The problem with that is as valuable and exciting as that is when you get there, it takes time … and it takes money … and there’s risk along the way. “We’re two for two with Acetadote® and Caldolor®, and we have four more on the way. But while we’re waiting for their arrival, we’re looking at other products we can bring in that are already approved,” he continued. “Now we’ve got three different areas we’re involved with – acute care, gastroenterology and oncology – and the logical choice for us for our next move is to add something in one of those three. We plan to continue to grow the lines of products and grow the teams supporting those products across the country,” Kazimi concluded.

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The branded name for amifostine, which Kazimi said was discovered at Walter Reed as the military and space programs looked to help protect soldiers and astronauts from radiation. “That work led to the development of this pharmaceutical product to help protect patients from the harmful effects of radiation,” nashvillemedicalnews

Kazimi explained. Although a small pharmaceutical company successfully launched the drug in America, the company was acquired by a larger firm … which was then acquired by an even larger firm in Great Britain … and the product languished. “It actually disappeared as a brand in the United States,” said Kazimi. Teaming up with Clinigen Group, plc, another British firm that had acquired the worldwide rights to amifostine, Cumberland entered an exclusive agreement to commercialize Ethyol in the United States in late 2016 and rolled the product out last year. “If you’re being treated for cancer, this can distinguish between your cancerous cells and your healthy cells,” Kazimi noted. “Radiation has become more precise, but we find there is still a need for a product like this.” He continued, “For example, it’s FDA-approved to protect your salivary and other glands when you’re getting treated for head and neck cancer.” Xerostomia (dry mouth) occurs in up to 80 percent of patients undergoing radiotherapy. For some, xerostomia impacts the ability to eat, chew, taste and swallow for the rest of a patient’s life. “By providing Ethyol, it can help prevent that from happening,” Kazimi said. He added, “It also will help women who are treated for ovarian cancer with a chemotherapeutic agent to help protect the kidneys.” In clinical studies, the use of Ethyol significantly reduced the number of patients experiencing treatment-limited nephrotoxicity compared to patients who did not receive Ethyol treatment.


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APRIL 2018



It’s a Wrap

Reflections on the Latest LHC Delegation to D.C. By CINDY SANDERS

Leadership Health Care (LHC) – an initiative of the Nashville Health Care Council for emerging industry leaders – wrapped up the group’s annual pilgrimage to Washington, D.C. on March 13. Now in its 16th year, the trip offers an exclusive opportunity for LHC members to hear directly from members of Congress, administration officials and national thought leaders from the public and private sectors on some of the most pressing topics in healthcare including policy priorities, federal healthcare spending, and reform implementation. Michaela Poizner, an attorney in the Nashville office of Baker Donelson who works with clients on healthcare transactions and compliance issues, shared her reflections on the 2018 fact-finding Michaela Poizner and networking event. NMN: You’ve been part of this delegation before. How does the program stay fresh and relevant? Poizner: The delegation does an excellent job of zeroing in on the topics that matter most right now — and we all know that in healthcare, that can change almost

minute by minute. So, while the delegation happens every year, it’s never stale. As long as health policy is interesting — and health policy will always be interesting — the delegation will be a dynamic forum for the conversation. NMN: What speaker stood out to you this year and why? Poizner: The keynote speaker, Chris Stirewalt of Fox News, was one of the more provocative keynotes I’ve seen at the delegation in recent years. Whether attendees agreed or disagreed with his basic premise — that government cannot cure what ails us as a country — there’s no denying the room was engaged. Let’s just say there was plenty to talk about at the after-dinner cocktail reception. NMN: Any sense from the experts on where health reform stands and what that might mean for the industry? Poizner: The collective sense seems to be that the time for repeal and replace may have passed, and the Affordable Care Act may be with us to stay. Going forward, Congress and the Department of Health and Human Services (HHS) will continue to tinker at the margins, as we’ve already seen with actions related to the individual mandate, cost sharing reduction subsidies, and short-term plans. But it appears

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that, at least for the foreseeable future, the Affordable Care Act will continue to be the framework we’re living under. NMN: Increasingly, the nation’s health system seems to be moving from an acute, episode-ofcare model to a more holistic, preventive care model. With that has come more recognition that social determinants impact outcomes. Was there any mention of ‘bigger picture’ healthcare efforts or coordination across multiple federal disciplines? Poizner: Several of this year’s delegation sessions addressed the role that social determinants play in health outcomes, particularly in rural parts of the country. For example, this theme echoed repeatedly in references to the opioid crisis – which touches not only public health but education, poverty, housing, and many other non-medical factors.  There is certainly a recognition, which came through loud and clear at the delegation, that to attack these big-picture problems, we need coordination beyond HHS and healthcare providers into schools, neighborhoods, police departments and places of worship. NMN: Any insights on Medicaid or Medicare? Poizner: Several sessions at the delegation touched on the evolution of the Medicaid program. This is an interest-

ing time for Medicaid, as states get more leeway from HHS to experiment with waivers. We are seeing this play out in the debate about work requirements for beneficiaries, for example, as states wrestle with whether Medicaid should continue to function as an entitlement program or play some other social insurance role. NMN: What were your biggest take-aways from the 2018 delegation? Poizner: It seems like every year, there are two or three themes that seem to find their way into multiple presentations. This year, those topics were valuebased reimbursement models and the opioid crisis.  We had a panel discussion on the opioid crisis, and the perspectives ranged from lawmakers to industry. But it is clear that there is consensus around the urgency of this issue as a public health emergency. As speakers throughout the delegation – speaking on a wide range of health policy matters – one after another referred to the opioid crisis in their remarks, it was clear that this issue is not far from anyone’s mind.  The same was true of value-based payments. Everyone from elected officials to financial analysts to journalists hit on the subject, underscoring its importance in the health policy discussion today.


The second Tuesday of each month, practice managers and healthcare industry service providers gather for the monthly Nashville Medical Group Management Association (NMGMA) meeting. During the March luncheon, Teddy Ansink with Sword and Shield discussed ‘Why Social Engineering Succeeds’ and what that might mean for companies trying to keep information from being compromised. Ansink started out by defining social engineering as: “The use of deception to manipulate individuals into divulging confidential or personal information that may be used for fraudulent purposes.” As part of his work, Ansink will often try to gain physical access to a client’s offices to see what areas can be breached and what information he can retrieve. Once inside, he said it’s often easy to walk into empty offices and snap photos of paperwork left on desks. There are a variety of ways he accesses areas where he shouldn’t be from ‘tailgating,’ which is going in right behind someone, to stepping on an elevator or walking up to a back area with his hands full and having someone push a button or open a door for him. “Employees have a desire to be helpful. This is one of the problems,” he said with a smile. He noted that between websites and LinkedIn, it’s easy to find the names of key staff members to casually drop into

conversation and make his visit appear legitimate. “Getting someone to challenge a person they don’t recognize can be difficult,” he noted, saying most people either don’t want to approach a stranger or want to be helpful if they do. The mindset, he suggested, needs to shift from ‘challenging’ someone to ‘meeting a new person.’ If an unrecognized individual tries to access a private area, a few friendly questions or checking the schedule could quickly ascertain whether the visit is legitimate and actually be helpful to the guest. If the story doesn’t check out, then the employee should escort the visitor to a public area and report the incident. Malware, phishing, baiting and other tactics also often succeed because employees are trying to be helpful. Ansink said emails from bad actors purporting to be from a boss are a tricky way to obtain sensitive information since most employees act quickly to fulfill a request from a supervisor. The simple solution is to verify the request is authentic, particularly if the required data includes private information on patients or clients. In addition to targeted training to thwart attempts at social engineering, Ansink advocated for restricting peripherals, adopting a clean desk policy when staff members leave their work areas, and empowering employees to question unknown people in private or restricted areas of the practice or office.

April 2018 NMN  

Nashville Medical News April 2018

April 2018 NMN  

Nashville Medical News April 2018