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FOCUS TOPICS CARDIOLOGY • LEGISLATIVE & REGULATORY AGENDAS

Your Middle TN Source for Professional Healthcare News

PHYSICIAN SPOTLIGHT PAGE 2

Ashok Babu,

Haslam Unveils Opioid Plan

TN Together to Fight Addiction through Three-Pronged Attack

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ON ROUNDS

A Closer Look at Post-Acute Cardiac Care For those fortunate enough to overcome the initial cardiac event, the days and months following are crucial to longterm survival ... 3

Teckro: Connecting Clinical Trials Worldwide Clinical trials are the lifeblood of therapeutic advancement. For those trying to manage or participate in them, they can also be unwieldy and administratively burdensome ... 8

Analysts Share Insights at Health Care Council Event More than 700 senior healthcare executives gathered in late January at the Nashville Health Care Council’s signature event, “Wall Street’s View on Prospects for the Health Care Industry,” to hear top analysts discuss the investment outlook for the coming year ... 9

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By CINDY SANDERS

On Jan. 22, Tennessee Governor Bill Haslam announced a multidisciplinary initiative to address the statewide opioid epidemic. Taking a three-pronged attack focused on prevention, treatment and law enforcement, TN Together tackles opioid addiction through legislation, proposed funding in the governor’s 2018-19 budget, and executive actions. According to information released from the governor’s office, Haslam’s FY 18-19 budget proposal will include a $30 million investment in state and federal funds to support the new initiative, which is expected to top the governor’s legislative agenda this session. TN Together was designed in partnership with the General Assembly through the Ad Hoc Opioid Abuse Task Force established by Speaker Beth Harwell and chaired by Speaker Pro Tem Curtis Johnson, alongside a working group established by Haslam. Of the 1,631 overdose deaths in 2016, opioid overdoses accounted for 1,186 of those deaths (up from 698 opioid overdose deaths in 2012). In addition, more than 7.6 million painkiller prescriptions were written in 2016 – exceeding the state’s entire population of 6.6 million that same year. “This is a crisis that knows no boundaries and impacts many Tennesseans regardless of race, income, gender or age. Our approach will be aggressive with provisions to limit the supply of opioids and significant state and federal dollars to provide treatment to those in need,” Haslam said. “I applaud the collaboration and the considerable work of the House and Senate on the TN Together plan, as well as the judicial branch’s leadership (CONTINUED ON PAGE 6)

Get with the Guidelines: Blood Pressure Edition ACC, AHA Redefine Hypertension By CINDY SANDERS

This past November, the American College of Cardiology and American Heart Association redefined the way clinicians and the public should think about ‘high’ blood pressure. After nearly three decades of decline, deaths from heart disease have been on the rise over the past couple of years. While there are multiple risk factors for cardiovascular disease, the good news is that a number of those risks are controllable, including decreasing blood pressure. Previously, stage 1 hypertension began at 140/90 mmHg. Now, patients with a blood pressure of 130/80 mmHg are considered

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to be hypertensive. Lowering the numbers has allowed clinicians to raise the warning flag sooner and institute lifestyle modifications and medication if warranted. “We’re getting aggressive in looking at how we define hypertension and making sure we’re not underselling blood pressure,” explained Walter Clair, MD, MPH, executive medical director for Vanderbilt Heart and Vascular Institute and president-elect of the American Heart Association – Greater Nashville. “We’ve all agreed for years that blood pressure is normal if it is less than 120 over 80,” he said. However, Clair continued, hypertension experts have (CONTINUED ON PAGE 4)

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PHYSICIAN SPOTLIGHT

A Nashville Transplant Story

Babu Helps Rebuild Saint Thomas Heart Transplant Program By MELANIE KILGORE-HILL

early on, and I had a combined interest in heart and lungs which really aren’t dissimilar from car engines. The heart and lungs are mechanical in many ways, and that appealed to me.”

A love of tinkering can set a curious mind on an unexpected path. Such was the case for Ashok Babu, MD, cardiothoracic surgeon and surgical director of the Saint Thomas Health heart transplant program. In 2016, the Illinois native arrived in Nashville to re-launch the hospital’s transplant program, now 42 hearts strong.

From Colorado to Nashville

A Mechanical Mind

“I had an engineering mind and was always interested in taking things apart and fixing them,” Babu said. “When I got old enough, I really enjoyed working on cars and would fix the family car ... sometimes with disastrous consequences. I really learned a lot from doing that.” While Babu went on to major in engineering at Chicago’s Northwestern University, medicine was in the back of his mind thanks in part to his physician uncle. “I liked the idea of medicine and working with patients and their families, and I had a lot of interest in medical devices,” he said. “Cardiac surgery interested me Don’t miss the last session in our HEALTHCARE HELPINGS educational series where we’ll serve up bites of knowledge — and breakfast!

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In 2002, Babu received his medical degree from Northwestern University and went on to complete general and cardiothoracic surgery residencies at the University of Colorado in Denver. He remained on staff at the University of Colorado Hospital, specializing in adult cardiac surgery, mechanical circulatory support, and heart transplantation. An encounter with a Saint Thomas surgeon at a national conference peaked Babu’s interest in the health system’s once thriving heart transplant program, now in need of a reboot. Saint Thomas West Hospital, a pioneering site for heart transplantation in Tennessee, closed its program at the end of 2011 but was looking to re-launch the specialty. “I was really impressed with the excellent surgeons and people I’d be working with and was enticed by the opportunity to restart a program and mold it in a way that’s best for the patient,“ Babu said. “The whole team – from the nurses to the OR staff – were just great people, and we liked Nashville.” Upon arrival, Babu worked alongside cardiac surgeon David Glassford, MD, who performed the state’s first heart transplant at Saint Thomas Hospital in 1985. Eighteen months later, the program is in full swing with Babu at the helm. “This is a team effort; it’s not just one surgeon or cardiologist,” Babu said. “Patients are treated by a surgeon and one of our five heart failure cardiologists who can determine when it’s time for more advanced therapies.”

More Options for Heart Failure

While heart transplant is the ultimate treatment for end stage heart failure, advances in short- and long-term support devices like ECMO are offering more hope to patients who previously had little. Extracorporeal membrane oxygenation drains the blood from the vein, adds oxygen and

removes carbon dioxide while warming the blood and pumping it through the body. This method allows the blood to “bypass” the heart and lungs, encouraging them to rest and heal. “The ECMO is a miniature heartlung machine and can support the body till the heart gets better or we can fix it,” said Babu, noting that most patients use the ECMO between 10-14 days. Another option – the left ventricular assist device, or LVAD – is a mechanical pump implanted inside a person’s chest to help a weakened heart pump blood. Babu said many elderly patients with end stage heart failure who are not candidates for heart transplant could now live for years with good quality of life thanks to advances in LVAD technology. Not surprisingly, technological breakthroughs have also created a shift in allocation of donor hearts. “The current paradigm for many patients is they get an LVAD, go home and come back for a heart,” Babu said. “Now heart allocation guidelines are being revised to favor hospitalized patients who may need LVAD, but we want to try to get them the heart instead.”

The Future of Cardiac Care

Babu looks forward to growing Saint Thomas’s mechanical support programs through ECMO, temporary and durable LVAD, and total artificial heart (TAH), reserved for patients with both right and left failed ventricles who are not candidates for LVAD. “There’s never been a great device for this population, who may end up on ECMO with no other hope besides heart transplant,” Babu said of the SynCardia TAH, which will be available at Saint Thomas Heart later in 2018. “We want to make the community aware of these devices because you can go to small hospitals around the region and people may not know they exist,” he said. “Our job is to educate other physicians and nurses about these technologies so they can educate their patients and refer them to us in a timely manner. We have a full heart failure program and provide every therapy available to this challenging population.”

New AHA/ASA Guideline on Crucial Stroke Treatment On Jan. 24, the American Heart Association/American Stroke Association released a new guideline that could make more patients eligible to receive critical treatments to remove or dissolve blood clots. Key Highlights: • A new guideline for treating acute ischemic stroke recommends an increased treatment window for mechanical clot removal from six hours to up to 24 hours in certain patients with clots in large vessels. • New recommendations also mean more patients will have access to a clotdissolving drug proven to lower chances for disability. More information available online at NashvilleMedicalNews.com

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A Closer Look at Post-Acute Cardiac Care More Patients Finding Meaning, Motivation in Recovery By MELANIE KILGORE-HILL

For those fortunate enough to overcome an initial cardiac event, the days and months following are crucial to long-term survival.

Get Moving

“The reality is exercise is medicine, whether its prior to a cardiac event to increase survival or in a post-event period to help your heart recover and revascularize from what it’s been through,” said David Liddle, MD, FACP, director of Vanderbilt’s Dayani Center for Health and Wellness. Dr. David Liddle Specializing in patients recovering from acute events or managing chronic conditions, the center helps patients facing medical challenges. In 2017 Dayani staff helped more than 200 cardiac rehab patients find the path to better health. “The data that supports the importance of exercise after a cardiac event is pretty overwhelming,” Liddle said. “No one can argue against that fact, although it’s more challenging to start a routine after someone’s had an event.”

Finding Motivation

For many patients, a life-changing event serves as an unwelcomed reminder of one’s own mortality and helps spur change. At the Dayani Center, a team of specialists including doctors, physical therapists, exercise physiologists, nurses, respiratory therapists and a health psychologist help motivate patients to work toward better health. Services include supervised exercise, aquatic programs, nutrition and other physical rehabilitation programs. One of the valuable tools used by Dayani team members is motivational interviewing. “We find out how a patient’s event has changed them, and what they would like to change,” Liddle said. “What do they want to be around for? We can tell someone they’d be happier and healthier with these changes, but what would those changes actually mean to them?” Family, retirement or career goals all are strong motivators for patients, which are put on a visual analogue scale to encourage progress. As the only certified medical fitness center in Middle Tennessee, Dayani staff members also care for people with left ventricular assist devices (LVAD) to improve morbidity rates. Their comprehensive approach includes blood work and a sixminute walk test, but Liddle emphasized that better numbers don’t necessarily translate into feeling better. That’s why staff

also screen for depression and take holistic approaches to establish patient measures. “If they don’t know what’s in it for them, they’re not likely to do it for the data,” Liddle said. “Are patients feeling like they’re meeting their own goals or ours? That patient-centered, motivation-driven experience is what sets us apart.”

Overcoming Barriers

Cardiologist Steven Humphrey, MD, chief of medicine at TriStar Southern Hills Medical Center, said pushing the heart is the most important benefit of cardiac rehab. “So many patients have to get through a tremendous emotional barrier to get back to their full activities,” Humphrey said. Dr. Steven Humphrey “Physically the heart may be a lot stronger ... but in a lot of cases, there’s a great deal of post-op discomfort. Patients have to learn the difference between typical post-op discomfort and dangerous cardiac problems.” Centennial Heart at TriStar Southern Hills educates post-acute heart patients through their three-phase cardiac rehab program. The program utilizes monitored exercise, disease management, education,

counseling and diet instruction to help patients increase physical fitness, reduce cardiac symptoms and reduce future risks. “The indication for cardiac rehab is expanding quite significantly,” said Humphrey. “Historically after a bypass or valve surgery, we begin patients in a 12-week program, three days a week for an hour. We have data that shows patients who’ve had surgery or are in heart failure and go through cardiac rehab live longer.”

A Growing Program

Southern Hills’ cardiac rehab program offers on-demand EKGs as patients start to push themselves and break through physical and emotional barriers postsurgery. While the hospital doesn’t offer heart surgery, Humphrey said the vast majority of heart patients don’t require it, meaning most can receive everything they need for improved cardiac health in their own community. In 2018, electrophysiology will be added to the hospital’s growing list of cardiac services, which include pacemakers, endovascular grafting and stenting, intraaortic balloon pumps, percutaneous coronary intervention and peripheral vascular angioplasty. “Southern Hills was the region’s first hospital to offer community-based stent placement, and those services are being expanded, as well,” Humphrey said.

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Heart Monitor Cardiovascular News of Note By MELANIE KILGORE-HILL

Mark Your Calendar

TriStar Health’s Annual Cardiovascular Symposium is set for March 2, 2018 at the Music City Center downtown Nashville. The event takes place from 8 am – 4 pm. Attendees will learn about the latest advancements in cardiac care including heart failure, electrophysiology, cardiogenic shock, structural heart disease, cardiovascular surgery and more. Register online at: https://tristarhealth.com/ medical-professionals/cme-programs/ cardiovascular-symposium.dot.

Cardiology Mile Markers at Saint Thomas

It’s a good time for cardiology at Saint Thomas Health, where their heart transplant program re-launched in 2016 following a hiatus. (See Ashok Babu, MD, this month’s physician spotlight feature on page 2.) The program also is participating in more than 15 clinical trials related to cardiovascular health and operates a thriving aortic program. Cardiologists at Saint Thomas Heart have implanted 47 Full MagLev™ HeartMate 3 Left Ventricular Assist System devices since late 2015. The HeartMate 3 LVAD system provides a new option for physicians managing advanced heart failure

patients in need of short-term hemodynamic support (bridge-to-transplant or bridge-to-myocardial recovery). The HeartMate 3 also provides patients living with their device new benefits that embody the evolution of LVAD therapy. It is the first device to receive FDA approval that is fully magnetically levitated, meaning the blood-pumping rotor has no bearings and is floating in a magnetic field. This makes the device more resistant to heat generation and thrombosis due to the design. Its predecessor, The Heartmate II, was the first continuous flow LVAD commercially approved and is the device that made long term mechanical support a reality. Both Saint Thomas and Vanderbilt participated in the clinical trials to evaluate the safety and efficacy of HeartMate 3.

TriStar Offers New Cardio Options

Staying a beat ahead, TriStar Centennial Medical Center recently completed Middle Tennessee’s first procedure utilizing the Tryton Side Branch Stent to treat a coronary bifurcation lesion involving a large side branch 2.5 mm or greater. The procedure was performed at TriStar Centennial Heart and Vascular Center led by

Paul Myers, MD, in collaboration with Jeffrey Webber, MD, interventional cardiologists with Centennial Heart. “TriStar Centennial is a national leader in cardiovascular care, utilizing the latest heart stent technology to treat high-risk cases of coronary artery disease,” Myers said. “This innovative and comprehensive approach allows us to treat patients with complex and high-risk blockages that involve arteries with important larger branches off the main heart artery.” TriStar Hendersonville also recently introduced the Tryton Side Branch Stent procedure to its comprehensive list of cardiac disease treatment options. In Smyrna, TriStar StoneCrest introduced CardioMEMS, which is the first and only FDA-approved heart failure monitoring system proven to significantly reduce heart failure hospital admissions and improve quality of life.

Vanderbilt Continues Cardiology Expansions

From electrophysiology to advanced treatment for valvular disease, Vanderbilt University Medical Center (VUMC) is expanding its cardiology services and medi-

Get with the Guidelines: Blood Pressure, continued from page 1 anticipated the guideline change for several years as the science has shown not only cause for increasing concern with a systolic number of 130 and diastolic measurement above 80 but also a benefit from treatment. “Even when we can show a correlation between bad outcomes and hypertension, we still have to show that treatment is going to make a difference,” he said. With the science in place, these new numbers are the first Dr. Walter Clair change in blood pressure guidelines since 2003. Previously, patients with blood pressures between 120 and 139 systolic and/ or a diastolic reading between 80-89 would have been classified as having ‘prehypertension.’ Now, anything greater than 120/80 is considered an elevated blood pressure. “It’s not ‘pre’ so we don’t say, ‘We’ll see you in a year,’” Clair said of the new trigger points. Instead, he continued, physicians should be intervening at that point and following up with patients more frequently to monitor improvement and sustainability. “Jumping all over it (hypertension) doesn’t mean you should necessarily start taking a drug for it,” he added in response to one concern some patients and physicians have voiced about the new guidelines. “But we begin to look more aggressively at cardiac risk factors … and you now have one, elevated blood pressure … so we 4

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should look at lifestyle, sodium intake, exercise, diet, smoking.” Realistically, Clair continued, lifestyle modification only achieves a decrease of about 11 millimeters of mercury so someone with a blood pressure of 160/90 probably won’t move the needle enough with lifestyle changes alone. However, he pointed out, those defined as having elevated blood pressure and stage 1 hypertension could quite likely get numbers back in the normal range without requiring medication. He was quick to add that doesn’t mean lifestyle modifications aren’t critical for everyone at any stage of hypertension. “Many people think because they are taking these blood pressure medications and controlling their blood pressure, they don’t have to give up that frequent flyer card to McDonald’s … yes, you do,” he stated. “You still have to do all of the other cardiovascular risk modification steps to get the full benefit. We continue to work to get that message out.” In addition to lowering the definition of high blood pressure, Clair said the new guidelines also reemphasized the correct way to take a blood pressure reading – making sure the person is seated correctly, using the proper cuff size, waiting a few minutes after the patient arrives in an exam room. “We kind of got a little lazy about checking blood pressure over the last few years,” he said. Technology, he added, can also be an important tool for getting an accurate read on blood pressure – particularly among a

couple of specific groups. Mobile technology, Clair noted, eliminates ‘white coat hypertension,’ where patients experience a jump in blood pressure simply by being in a medical setting. “We now have the capability to actually look at people’s blood pressure at home to see if they are really normal or not,” he said. “The other group is people who are suspected of having high blood pressure,” Clair continued. “Those people … believe it or not … actually have blood pressures that look pretty good, but it’s labile.” While they test normal at the physician’s office, they actually have elevated numbers at home or work. “We have these two extremes of people – those who might be over-diagnosed and those who might be missed.” The rising death rates underscore just how important it is to properly identify those at increased risk of heart disease. Additionally, Clair said, “We are worried the increase in childhood obesity is a precursor of another surge in cardiovascular disease.” He continued, “For many years in cardiology, we have been striving to be the #2 killer … it’s a credit to our colleagues in oncology that cardiac disease and stroke remain #1 killers of both men and women in the U.S.” Noting that being the leading cause of death isn’t a designation anyone wants, Clair said more aggressively monitoring and treating elevated blood pressure is one important step toward improving heart health.

cal staff to reflect the latest treatments and research available.

Heart Transplant Program

VUMC was recently recognized as the second busiest heart transplant program in the nation, falling just behind Cedars-Sinai Medical Center in Los Angeles. “We’re continuing our positive evolution on campus as a world leader in heart transplant surgery,” said cardiologist Daniel Munoz, MD, MPA, assistant professor and medical director for quality in the Division of Cardiology at Dr. Daniel Munoz Vanderbilt. In 2017, 82 adult hearts were transplanted at Vanderbilt, with survival rates higher than the national average. “Our volume has grown tremendously in part to our leadership and the outstanding clinicians we’ve been able to recruit, but we’re especially proud of the quality of our services and the chance to care for the most medically complicated cases,” Munoz said.

Arrhythmia Services

VUMC is also taking its arrhythmia program to the next level with recruitment of internationally recognized electrophysiology cardiologists. Recent newcomers include William Stevenson, MD, and Gregory Michaud, MD, who serves as director of Arrhythmia/Electrophysiology in the Department of Medicine. Both specialists were recruited from Brigham and Women’s Hospital at Harvard Medical School. “This is an already great program positioned to become a preeminent program thanks to Dr. Michaud’s leadership,” Munoz said. “One of the key challenges in ablation of atrial fibrillation is that not all procedures are equally successful, so it’s really important to continue to understand best techniques to makes ablation as successful as possible.”

Valvular Disease

Another area of focus for Vanderbilt is the treatment of valvular heart disease. “We’re increasing the number of technological options for treatment of heart disease,” Munoz noted. “Open-heart surgery remains the best option for certain patients; but over the past decade, catheter-based treatment of valve disease has emerged. We’re trying to understand which patients benefit the most from these technologies and create a partnership between clinical services and researchers to understand not just how to do something but the best way to do it for the benefit of as many patients as possible.”

Research

Vanderbilt has also continued to be on the leading edge of clinical research, having received three Strategically Focused Research Network grants from the American Heart Association designed to focus on disease prevention, obesity and vascular disease. nashvillemedicalnews

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NMGMATen Minute Takeaway By CINDY SANDERS

The second Tuesday of each month, practice managers and healthcare industry service providers gather at Saint Thomas West Hospital for the monthly Nashville Medical Group Management Association (NMGMA) meeting. During the January luncheon, Melanie Adams, executive director of the Center for Executive Education at Belmont University, discussed “Coaching through Change.” The interactive presentation included exercises that called upon attendees to think through best practices, pitfalls, and effective communications strategies to help Melanie Adams guide organizations during times of transformation. Starting with the recognition that ‘change is hard,’ Adams noted people sometimes expend far more energy looking for workarounds rather than adapting to change, particularly if they don’t feel properly engaged and trained in the process. She asked the audience to consider the different emotions aligned with the notion of having change done ‘to us’ versus ‘by us.’ “When researchers have studied change in major organizations, what they found is over two-thirds fail,” she said.

“Of the change initiatives that failed, what is even more surprising is that it’s not because they were bad ideas.” In fact, Adams continued, when researchers drilled down, more than 95 percent of the ideas were good solutions to real problems. “So why are we not able to make those changes happen?” she questioned. The answer, Adams continued, is tied to execution and involvement. “There is one key factor that really separates success from failure,” she noted. “It’s the buyin … it’s the personal commitment.” Adams said it is easy to blame a lack of funding, technology or other resources when a change project falters. While all of those items are nice to have in abundance, she said none are the true differentiator between success and failure. “What actually gives us the advantage is the ability to engage others.” Adams added, “This is not new information, but it’s incredibly hard to do within the complexities of our organizations.” Adams shared several key steps to help NMGMA attendees shift their physician practices into the success category the next time a change project emerges (as happens on a regular basis in the healthcare industry). The first tenet, she noted, is that personal change precedes organizational change. “Individuals will really struggle with connecting to organizational change if they don’t see a personal connection,” she noted, adding that’s as true for the lead-

ership team as it is for frontline employs. “This is the starting point … not the organizational strategy.” Once team members understand the impact the change is expected to have on their workflow, then individuals have to be motivated to take the necessary steps. Adams said one option is an extrinsic ‘carrot/stick’ approach. However, she continued, “We know from research that type of motivation works … but only for a short amount of time so it’s not sustainable.” Instead, she continued, “We really need to connect with those internal drivers … those intrinsic drivers.” Pulling from Daniel Pink’s book “Drive: The Surprising Truth About What Motivates Us,” Adams said there are three main factors that propel motivation: Mastery: the desire to get better or be a subject matter expert, Autonomy: the desire to direct our own lives … or at least control our piece of the change initiative, and/or Purpose: the feeling we can make a difference or that we are part of something bigger that will have a real impact once the change is implemented. “I’m going to add one more to Dan Pink’s list,” Adams said. “Sometimes a sense of urgency is the exact thing people need to hear. As leaders, we tend to hold off on sharing the scary stuff with the masses because we don’t want people to worry.” However, she continued, full disclosure also has its merits in certain cir-

making a move?

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cumstances so that employees understand the immediacy when there is a need to rapidly implement change. Effective communication is the linchpin of any change initiative. Adams said it’s critical to provide information on why the change is necessary and how it will ultimately improve an individual’s function and workflow. “You might also consider talking about what’s not going to change to give people something to hold onto,” Adams counseled. Equally, she said it’s important to validate team members’ feelings of concern over how the change might initially impact their perceived job competence and routine. “Then … and only then … are people ready for the vision,” she concluded.

NMGMA in February The next meeting – scheduled for 11:30 am-1 pm on Tuesday, Feb. 13 – features James Fields, owner and president of Concept Technology who will share “Best Practices of the Hiring Process.” For event parking and directions or to register, please go online to nmgma.com. Practice managers interested in attending a luncheon to learn more about the organization and educational topics, should email NMGMA President Joy Testa at joytesta@ bellsouth.net to register for their first meeting as a guest.

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Doctors Aim for Another Big Year on Capitol Hill

TMA Day on the Hill Tuesday, March 6

The 2018 legislative session is in full swing, and the Tennessee Medical Association looks to follow a banner year in 2017 with another round of successful advocacy in the Tennessee General Assembly. TMA physician leaders and staff review hundreds of issues each year and ask for input from By JAMES K. more than 9,000 ENSOR, JR., members across MD, FACP the state to deter- Chair, TMA Board mine the most of Trustees important and timely healthcare issues. The TMA Legislative Committee makes a recommenation for the board to approve prior to the start of the session each year; and by January, the state’s largest professional organization for doctors is strategically pushing its agenda with lawmakers in Nashville. There are only a handful of top priorities on the list this and every year, but TMA inevitably spends as much or more time, energy and resources protecting doctors from legislation that could harm the profession or our patients. TennCare Episodes of Care:

Doctors have grown increasingly frustrated by the inconsistent, inaccurate and ineffective TennCare episodes of care payment model. TMA has long advocated for improvements – most recently meeting in January with TennCare representatives and officials from the Haslam administration – but the state has not addressed fundamental flaws in the design and implementation of the program and has given no indications that it intends to respond to physicians’ concerns. TMA is prepared to ask the legislature to intervene. Learn more about TMA’s position and related advocacy work at tnmed.org/ episodes. Doctor of Medical Science: Sponsors have filed the updated version of a Doctor of Medical Science bill. The language is much improved from the 2017 version, which would have created a new academic degree for physician assistants and a pathway to giving PAs independent practice. The new bill does not give PAs independent practice but requires PAs to collaborate with a supervising physician in a team-based healthcare delivery model. TMA remains opposed to the legislation and is advocating for a different name to avoid patient confusion in a clinical setting. Balance Billing: TMA remains actively involved in the balance billing debate and is working with stakeholders

TMA will host the annual event at the Legislature’s new home in the Cordell Hull Building. More than 300 physicians attended last year’s Day on the Hill to meet with lawmakers, attend committee hearings, and advocate for their profession and patients. Learn more about this free event at tnmed.org/dayonthehill. TMA will also connect doctors and legislators during the legislative session through its volunteer Doctor of the Day program (tnmed.org/doctoroftheday) and other functions of the association’s grassroots network (tnmed.org/grassroots).

toward a solution to “surprise medical bills” that is reasonable to physicians and patients. TMA opposes any effort that gives health insurance companies even more undue leverage to force providers to accept unfair contractual terms and proliferates the trend of narrow networks. Maintenance of Certification: In 2017, after years of complaints from members about the costly, burdensome and in many cases valueless maintenance of certification requirements, TMA helped pass legislation that prohibited MOC as a requirement for medical licensure in Tennessee. This year, TMA seeks to prohibit hospitals and health insurance companies from requiring MOC for physician credentialing or network participation, or at least give physicians options to the ABMS Board monopolies. Tennessee’s ongoing opioid abuse epidemic promises to be a hot topic of debate in the legislature. TMA will continue education efforts to help prescribers reduce initial prescriptions, as

well as advocating for more funding for comprehensive drug treatment programs and more resources for law enforcement to counter the alarming rise of fentanyl and other illicit drugs that are contributing to the increase in accidental overdose deaths. We also look forward to getting more details and actively participating in the legislative process surrounding Governor Haslam’s TN Together plan (see page 7) announced in late January. As the largest professional organization for doctors in Tennessee, TMA is the conduit to make sure physicians have a unified, influential voice in important public policy decisions affecting the delivery of healthcare in Tennessee.

scriptions with “reasonable exceptions,” more education about risks and addiction for both the general public and healthcare providers, investment in treatment and

recovery services, additional resources to address illicit sales and trafficking of opioids, more beds dedicated to prisoners fighting addiction, and equipping every Tennessee state trooper with naloxone. Tennessee Medical Association 2017-18 President Nita Shumaker, MD, said physicians look forward to getting more details on the TN Together plan and actively participating in the legislative and regulatory process. “Our priority Dr. Nita Shumaker within the medical community has been … and still is … prescriber education and prevention of substance abuse disorder. We have made some progress in reducing initial opioid prescriptions but still have a long way to go,” she said. “We must continue to promote alternative pain management treatments that do not involve opioids while ensuring that treatments are covered by health insurance.” She continued, “We do need to reduce supply and dosage, particularly for new patients and acute episodes like the hospital ER. At the same time, we want to make sure that any law(s) limiting

Dr. James Ensor practices internal medicine in Germantown and serves as 2017-2018 chair of the Tennessee Medical Association Board of Trustees. TMA is a voluntary, nonprofit professional organization for doctors, serving more than 9,000 members across Tennessee. Follow TMA’s legislative progress at tnmed.org/legislative or on twitter @tnmed and @tnmedonthehill.

Haslam Unveils Opioid Plan, continued from page 1 through the Regional Judicial Opioid Initiative and National Opioid Task Force, and I ask all stakeholders around this issue to work together to achieve real reform and action

that will save lives.” Major components of the plan (see box) call for legislatively mandated limits to the duration and dosage of opioid pre-

TN Together Key Components Legislation to address prevention by limiting the supply and the dosage of opioid prescriptions, with reasonable exceptions and an emphasis on new patients. Initial prescriptions will be limited to a five-day supply of drugs with daily dosage limits of 40 MME. • Limiting coverage for TennCare enrollees to an initial five-day supply with daily dosage limits.

• Increasing prevention education in grades K-12 through revisions to the state’s health education academic standards. • An executive order, issued on Jan. 22, establishing a special commission to formulate current, evidenced-based pain and addiction medicine competencies for adoption by the state’s medical and healthcare practitioner schools.

• Identifying women of childbearing age who are chronic opioid users and providing targeted outreach about risks and treatment in order to aid in the prevention of Neonatal Abstinence Syndrome (NAS) births. • Investing more than $25 million for treatment and recovery services for individuals with opioid use disorder. These services will include an increase in peer recovery specialists in targeted, high-need emergency departments to connect patients to treatment immediately.

• Improving the state’s data systems to better and more timely identify critical hot spots for targeting resources and increasing information about patient and community risks.

• Legislation that expands residential treatment and services for opioid dependence within the criminal justice system and creates incentives for offenders who complete intensive treatment programs while incarcerated – a best practice that is proven to reduce recidivism, improve lives and communities and save taxpayer dollars.

• Attacking the illicit sale and trafficking of opioids by providing additional resources to the Tennessee Bureau of Investigation for rapid response teams and, through legislation, penalizing the use and unlawful distribution of dangerous and addictive drugs, including those that mimic the effects of fentanyl, a drug that is up to 100 times more potent than morphine and is linked to an alarming number of overdose deaths. • Providing every Tennessee state trooper with naloxone for the emergency treatment of opioid overdose.

(CONTINUED ON PAGE 7)

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2018 Legislative Session Brings Opportunities, Challenges for Hospitals Since the Tennessee General Assembly reconvened on Jan. 9, a steady stream of new legislation has been filed, with dozens more bills expected before the Feb. 1 deadline. Among those proposed bills are a number of priorities for Tennessee Hospital Association and its 138 By CRAIG BECKER member hospitals President & CEO, to ensure reli- THA able and quality healthcare for the people of the state. Legislators are rightly focused on addressing the state’s opioid crisis, and hospitals share that commitment. For the past several years, THA has been working closely with the Tennessee Departments of Health and Mental Health and Substance Abuse Services to reduce opioid prescriptions, prevent abuse, and provide treatment for those struggling with addiction. In addition, hospitals support legislative and policy efforts that confront the opioid epidemic head-on and will continue to partner with lawmakers and state agencies, especially during this legislative session. This work is seen most directly in the recent announcement by Governor Bill Haslam, Lt. Governor Randy McNally and House Speaker Beth Harwell to launch TN Together (see page 1), which includes legislation to reduce prescribing limits and modify the frequency and manner of use of the state’s controlled

substance monitoring database. Working together, we can turn the tide on this devastating issue. In addition to the opioid issue, hospitals have several other legislative priorities to address in the coming weeks. As always, the hospital assessment is the centerpiece of THA’s agenda. Established in 2010, the annual assessment helps generate roughly $452 million in state funding for the TennCare program. When coupled with federal matching funds, the amount totals more than $1.3 billion. Those dollars help maintain several enrollee benefits and avoid steep cuts to provider reimbursement. THA also will bring a few technical bills that update state law to include claims data reporting by psychiatric hospitals to the Tennessee Department of Health and to streamline sections of the code in accordance with new federal regulations. Outside THA-led legislation, there are three other priorities that hospitals and health systems will be closely watching. THA supports extending the Health Services and Development Agency, which oversees the state’s certificate of need program. The state agency is set to expire at the end of the fiscal year and is up for a three-year extension. A lingering issue from 2017 is maintenance of certification (MOC), which will undoubtedly receive a significant amount of attention this session. The proposed legislation would prevent hospitals from requiring maintenance of board certification as a condition for physician privileges. While not all hospitals in the state require MOC by physicians, there is broad agreement that legislating the hospitals’ processes to ensure qualified providers is not

good policy. It is critical for hospitals and their medical staffs to remain autonomous in the ability to set standards and expectations of physicians. Another major issue for 2018 is balance billing, or bills for out-of-network physician services provided at in-network facilities. Multiple bills are expected, and THA supports a comprehensive solution that ensures adequate provider networks and fair reimbursement for healthcare providers, while avoiding a negative impact on patients. Beyond legislation is the troubling financial landscape for rural hospitals. With nine rural closures in the state since 2012, Tennessee ranks second in the country for such occurrences. While the drivers for closure are varied – reduced volumes, unbalanced payer mixers and reduced reimbursement, higher uncompensated care and greater chronic disease among patients – the reality is undeniable. Rural hospitals are in dire straits and closures have ripple effects far beyond healthcare. Typically, rural hospitals are among the county’s largest employers, which translates to local jobs and tax revenue. The closure of these facilities deals a direct blow to the local economy and makes future economic development incredibly challenging. A local healthcare presence is

necessary when it comes to recruiting new businesses and bringing additional jobs to rural communities. THA’s small and rural members are partnering with other stakeholders and state agencies to identify solutions to keep a medical presence in communities and develop financially viable delivery and operating models that ensure a stable future for healthcare in Tennessee’s rural areas. The coming weeks are sure to be busy, as hospitals tackle this broad list of priorities. However, this work is essential to maintaining and advancing quality, affordable healthcare for all Tennesseans. THA is proud to lead these efforts. Craig Becker has served as president and CEO of the Tennessee Hospital Association and its subsidiaries, THA Solutions Group, Inc., and the Tennessee Hospital and Education Research Foundation, since August 1993. He holds a master’s in administration and a bachelor’s in journalism from Rider University in Lawrenceville, NJ. Founded in 1938 to serve as an advocate for hospitals, health systems and other healthcare organizations across the state, THA initiatives support the efforts of Tennessee hospitals to ensure high quality care for the patients and communities they serve. For more information, go online to tha.com

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Haslam Unveils Opioid Plan, continued from page 6 physicians’ ability to prescribe have reasonable exceptions to continue giving relief to patients in legitimate need, such as chronic pain, oncology or hospice patients.” Shumaker said physicians have led the charge toward safer and more appropriate prescribing patterns over the last several years. She noted physicians and other prescribers should follow the Centers for Disease Control and Prevention chronic pain guidelines, continue to champion consistent use of the Tennessee Controlled Substance Monitoring Database, encourage screening prior to therapy, reduce the number of opioids supplied as appropriate, and educate patients about risks, safe storage and proper disposal so unused drugs don’t fall in the wrong hands. (For additional thoughts from Shumaker on the opioid crisis, see the September 2017 article “Taking the Bull by the Horns” online at NashvilleMedicalNews.com.) She added TMA is on record calling for more funding for drug treatment pronashvillemedicalnews

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grams. “Tennesseans need more access to comprehensive, affordable programs that go beyond detox and offer more effective long-term results, especially for low-income people. It is important that funding is available for community support services after treatment, as well.” Centerstone CEO Bob Vero, EdD, who oversees the national behavioral healthcare organization’s Tennesseebased operations, added his support for the new initiative. “Centerstone applauds Governor Haslam for his strong commitment to helping Tennesseans combat this deadly opioid crisis that is impacting individuals, families and communities across our state,” he said. “TN Together sends a clear message – there is no single, simple solution,” Vero continued. “Our approach must minimally address strategies and sufficient resources for prevention, treatment and law enforcement. It’s time for greater collaboration and cooperation. It’s an allhands-on-deck call to implement strategies that will help save lives.”

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HEALTHCARE ENTERPRISE

Teckro: Connecting Clinical Trials Worldwide Global Company Makes Nashville U.S. Headquarters By CINDY SANDERS

Clinical trials are the lifeblood of therapeutic advancement. For those trying to manage or participate in them, they can also be unwieldy and administratively burdensome … but a startup from Ireland that now also calls Nashville home is working to streamline the processes to improve oversight, transparency, compliance and access. “Clinical trials impact everybody. It’s ultimately the way we get new drugs to market,” noted Teckro Co-founder and CEO Gary Hughes. “Unfortunately, there are a lot of bottlenecks in terms of the time it takes to get drugs through the process. We felt there was a real opportunity to digitize a lot of the Gary Hughes activities that happen in clinical trials.” It’s a space where Hughes has depth of experience. The genesis of Teckro was with a previous company he co-founded to support clinicians entering into clinical research. That company was ultimately

acquired in 2011 by ICON, a global clinical research organization for drug development with offices in Middle Tennessee. Seeing the clinical trial process from start to finish led Hughes and his partners to ‘build a better mousetrap’ using information retrieval and machine learning technologies to improve the speed and accuracy of clinical trial conduct. “The company was

Quality.

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We have invested heavily in That’s why NVAVI is the only the Vascular Quality Initiative™ vascular surgery practice in sponsored by the Society for Middle Tennessee that fully Vascular Surgery. The VQI is a participates in VQI. database that measures our results But more than just measuring and compares them with quality, the experienced vascular surgeons and team led by Dr. Patrick practices around the United Ryan uses data to States. We continually believe to be enhance best really serious practices about quality, and improve www.nvavi.com you must measure it. outcomes.

In addition to seeing patients in Nashville, Dr. Ryan is now seeing new and established patients in Pleasant View 330 23rd Avenue North, Suite 100 | Nashville, TN 37203 | 615.321.6100

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founded in mid-2016. We went live with our first product a few months later,” said Hughes. “We think there are big problems to solve in clinical trials, and there’s huge opportunities for the companies that are able to solve those problems.”

largely it’s because they are quite difficult to do,” said Hughes. Dana Poff, chief operating officer for Teckro, said the administrative burden of running a trial on top of the normal patient workload has been a barrier for some physician offices, particularly community sites that aren’t used to conducting research. “The easier we can make it for them to Dana Poff do, the more accessible their time is going to be to bring more patients into the trial, and the more likely those sites will then repetitively be in future trials,” said Poff. “If you’re in the west of Ireland, for example, your chances of getting on a clinical trial are greatly diminished compared to someone who is based in Nashville,” concurred Hughes. “I think that’s where we see a huge opportunity with this platform is being able to make trials more accessible.”

Transformational Technology

Establishing a Nashville Base

The goal was to create a technology solution that would enable improved data capture and oversight in a highly intuitive interface that was easy for all stakeholders to use. “Overall, what we try to do is simplify the conduct of clinical trials … really make it easier for more sites globally to participate in clinical research and also easier to do so in a way that’s more compliant with the protocol and gives greater transparency and oversight to the pharma company,” said Hughes. The first step was to move away from the cumbersome paper-filled binders that seem to be an inherent part of most trials. For the most part, Hughes said clinical trials at sites across the world are largely still conducted in the same manner as they were in the 1980s. People carrying around huge binders of information and frequent monitoring visits to check on compliance are still the norm. The Teckro tool allows users to interface with the highly secure cloud-based platform in any manner that’s convenient, including handheld mobile devices at the point of contact with the patient. “Virtually everything in clinical trials today works off retrospective data,” Hughes continued. “It’s always looking back at what happened in the past. I think digital really opens up the opportunity to have that realtime connection with all the stakeholders involved with the clinical trial.” In addition to making trials more efficient and transparent, expanding the number of community sites is another critical need. It isn’t uncommon for a physician who has participated in a clinical trial in the past to opt not to do another one. “That can be for many reasons, but

Pharmaceutical companies are Teckro’s primary clients, and the technology startup now works with most of the top 20 pharma organizations in the world to help them effectively and efficiently engage with clinical research sites. “We’ve been involved in global clinical trials across all indications, across all phases,” Hughes noted, adding there are several thousand sites in approximately 40 countries now using Teckro technology. With an expanding client base has come expanding staff needs. Hughes said the company has grown to about 65 employees at this point. “Currently, the vast majority of those are in Ireland, but we see significant growth in the Nashville office over the next 12 to 18 months,” Hughes said. One of the first Middle Tennessee hires was Poff, who joined Teckro to oversee and grow operations last fall. Poff previously held senior leadership roles in clinical operations, project management and alliance management for ICON and brings with her nearly 30 years’ experience in healthcare and clinical research. As part of Teckro’s rapid growth, the company began searching for the right location for a U.S. headquarters to complement the global headquarters in Ireland and decided on Nashville. “It helped Dana was here,” Hughes said with a smile, adding the expertise found at Sarah Cannon, Vanderbilt, and clinical research organizations throughout the area, along with the strong healthcare industry ecosystem, soon set Middle Tennessee apart. Coming from Ireland, he noted the people, culture and work ethic (CONTINUED ON PAGE 9)

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Analysts Share Insights at Health Care Council Event PHOTO CREDIT: DONN JONES PHOTOGRAPHY

More than 700 administrator, you senior healthcare execprobably need to think utives gathered in late more about marketJanuary at the Nashville ing and branding as a Health Care Council’s long-term strategy as signature event, “Wall opposed to fundraisStreet’s View on Prosing.” pects for the Health The analysts Care Industry,” to hear explored perspectives top analysts discuss the on various healthcare investment outlook for sectors, including the coming year. acute care, post-acute The conversacare, ambulatory sertion was moderated by vices, managed care, Wayne T. Smith, chairhome care, medical man and CEO, Comdevices and pharmamunity Health Systems, ceuticals. (L-R) Frank Morgan, Wayne Smith, Kristen Stewart, Hayley Hovious, A.J. Rice, and Joshua Raskin and included Frank “Senior housing Morgan, managing should continue to director, RBC Capital Markets; Joshua see growth because there is an increasthe next five years. Raskin, senior research analyst, Nephron ing number of people needing it as baby “There will be a resurgence of priResearch LLC; A.J. Rice, managing direcboomers age. Also, seniors have the money mary care delivered in new places like tor, Credit Suisse; and Kristen Stewart, to buy it because the stock and housing the workplace and home, and these are director, Deutsche Bank. markets have been good,” Raskin said.  important developments to watch,” Rice Major themes from the discussion “Some sectors will likely perform said. “Managed care companies are movincluded M&A activity, drug pricing, conbetter than others, but healthcare so far ing into new areas that affect people’s sumerism, and emerging technologies. this year is still outperforming the overall overall health, such as social, mental and The panelists identified several trends for market and I think should continue to be financial demands.” investors to watch, and they agreed techpositive across most healthcare sub secRaskin pointed out that “if individunologies that get patients more engaged tors,” said Stewart. “We are keeping an als are going to be armed with the actual with their own care … and help to deliver eye on vertical integrations that could data around cost and quality, you’re going value ... will be worthy investments over change delivery models and value-based to see shifts in pricing. If you’re a hospital

healthcare.” “Within the post-acute continuum, the home health industry is best positioned for growth as payers and policymakers attempt to move patients to the most clinically appropriate and lowest cost setting of care,” said Morgan. “Though ambulatory care has experienced the same utilization pressures experienced of late by acute hospitals, the industry will do well in the long term because it is a lower cost option to the healthcare system and is preferred by physicians, patients and payers,” he continued. Panelists identified HCA, Zimmer Biomet, United Health, Acadia, Anthem and Envision Healthcare as companies to watch in 2018. Nashville is headquarters to 18 publicly traded healthcare companies, which employ 500,000 people throughout the world and see $84 billion in annual revenue. “Nashville companies are uniquely positioned to make contributions that will significantly improve healthcare across the country. Wall Street investors continually look to Nashville as they analyze trends, and the Council is proud to host this important discussion on the future of the industry,” said Smith, who is also a member of the Nashville Health Care Council Board of Directors.

Teckro: Connecting Clinical Trials Worldwide, continued from page 8 found in Nashville also really resonated with the leadership team … “not just the country music, which is huge in Ireland,” he added with a laugh. “I think Nashville gives us a great base, not just to build up the clinical expertise within the team, but to establish leadership over here to take the company forward,” said Hughes. He added the geographic location also provides easy access to East Coast clients and puts biopharma companies on the West Coast within a few hours of flight.

Next Steps

Poff said Teckro’s experience across multiple therapeutic areas is one of the company’s value propositions. With insights gained from different types of trials and ongoing customer feedback, Teckro continues to enhance and refine their clinical trials tool. “The voice of the user is very important to us,” said Poff. “That helps us shape future services within the tool. We want to meet the needs of the user – not just what we think is going to be best but what’s really going to help the sites, the investigators and our sponsors run their trials more effectively and efficiently.” Positive feedback coupled with the ability to customize the technology to meet the specific needs of each trial has led to strong growth within the pharmaceutical vertical. Poff said the next stage in the company’s continued expansion is to engage with established large site networks deploying their own research to look at opportunities to work collaboratively. nashvillemedicalnews

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The Impact of Clinical Trials in Tennessee On Jan. 23, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a new report that finds there are more than 945 active clinical trials in the Tennessee. Additionally, the report said the life science industry supports 52,000 jobs and contributes $11.7 billion to the state’s economy. “Research in Your Backyard: Developing Cures, Creating Jobs, Pharmaceutical Clinical Trials in Tennessee,” was released at an event held at the Cordell Hull Building, which featured a panel discussion by Vanderbilt University Medical Center biotech researchers, Tennessee State Senator Mark Green, MD, (R-22), and a local Alzheimer’s disease patient and clinical trial participant. “Clinical trials offer patients novel medical treatments while also allowing biopharma research organizations to innovate and grow,” said Green, founder of Align MD. “Across the state – and particularly here in Nashville – the healthcare industry has had a profound impact on our economy.” In the United States, there are more than 7,000 open clinical trials being sponsored by the biopharmaceutical industry, universities, individuals and organizations. In Tennessee, active trials are studying treatSen. Mark Green, MD, discusses the importance of local clinical trials and ment options for more than 20 disease sites biopharmaceutical research in Tennessee. Pictured (L-R) James and Josi Felts, Dr. Paul or types, with cancer trials leading the way Newhouse, Dr. Jeffrey Conn, and Sen. Mark Green. by a large margin. Of the 945 open clinical trials involving the biopharmaceutical research industry, Vanderbilt is collaborating on more than 245 of them. In addition, the report cites Meharry Medical College, Sarah Cannon, Clinical Research Associates, Tennessee Clinical Research Center, Tennessee Oncology, Tennessee Retina, and all of the city’s major hospitals and health systems as active participants in Nashville. “Many top universities call Tennessee home and are centers of innovation,” said Jeffrey Conn, PhD, director of the Vanderbilt Center for Neuroscience Drug Discovery. “Maintaining strong partnerships between medical universities and life science companies allows us to foster developments right here in Tennessee that can then help save lives far beyond our state lines.” On average, it takes approximately a decade for new medicines to go through the FDA approval process, and only 12 percent of drugs successfully make it through clinical trials. Since 2004, biopharmaceutical research companies have conducted more than 6,100 clinical trials in Tennessee. The complete report is available online at NashvilleMedicalNews.com   FEBRUARY 2018

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DOJ Signals New Approach to Frivolous Qui Tam Actions The Department of Justice (DOJ) recently made a surprising announcement that it may begin seeking dismissal of meritless qui tam cases brought under the False Claims Act. This announcement was made by Michael Granston, director of the Civil Fraud Section of the DOJ’s Civil Division, at By J. MATTHEW KROPLIN the Health Care Compliance Association’s Healthcare Enforcement Compliance Institute in November 2017. The False Claims Act permits an individual, known as a “qui tam relator” (or more com- & ADAM W. monly, a “whistle- OVERSTREET blower”), to bring a lawsuit on behalf of the United States when that person has information that the

defendant “knowingly” submitted false or fraudulent claims to the federal government. Liability for violations of the False Claims Act includes civil penalties and treble damages. More than half of the False Claims Act recovery comes from the healthcare industry, the vast majority of which results from qui tam actions. In 2016 alone, the federal government obtained more than $4.7 billion in settlements and judgments under the False Claims Act, with $2.5 billion of this coming from the healthcare industry. And almost nine out of 10 False Claims Act cases within the healthcare industry have traditionally resulted from qui tam claims. The False Claims Act includes detailed procedures and requirements for filing a qui tam action. Among other things, the complaint must be filed under seal for at least 60 days while the DOJ investigates. After its investigation, the DOJ may (1) intervene and prosecute one or more of the claims as a plaintiff; (2) decline to intervene, in which case the relator may prosecute the claims on behalf of the United States; or (3) move to dismiss the complaint. Regarding the third option, the DOJ has statutory authority to move to dismiss a False Claims Act case that lacks merit

For 50 years Matthew Walker Comprehensive Health Center has carried on our namesake’s legacy by keeping Nashvillians healthy.

even over the relator’s objection, as long as the government gives sufficient notice of the motion and the relator has an opportunity to request a hearing. Although courts have generally been extremely deferential to the DOJ’s decision to dismiss a qui tam action, the DOJ has rarely exercised this authority. Instead, the second option is far and away the most frequently used by the DOJ: it intervenes in fewer than 25 percent of qui tam actions, and in virtually all of the other instances, it traditionally allows the relator to proceed with the case regardless of its merits. Nevertheless, a very small portion of the total False Claims Act recovery over the past several decades — less than five percent — has resulted from cases in which the DOJ declined to intervene. Accordingly, the government’s decisions in around 75 percent of qui tam cases — to neither intervene nor seek dismissal – has forced defendants to incur substantial litigation costs defending against a significant number of meritless claims. The government’s stated intention to begin seeking dismissal of frivolous qui tam cases recognizes the burden of protracted litigation upon courts and the healthcare industry. Whether the recent DOJ announcement leads to actual change remains to be seen, but it signifies a potentially encouraging policy shift for healthcare companies that spend millions of dollars every year defending frivolous qui tam actions. In fact, on January 10, Director Granston issued a memorandum providing specific guidance as to how the DOJ will approach evaluating whether to seek dismissals, which we plan to summarize in next month’s edition of Nashville Medical News. Glaser, David M., Developing Story: DOJ Will Dismiss Qui Tam Cases Lacking Merit. RAC Monitor (Nov. 2, 2017), available at https://www.racmonitor. com/developing-story-doj-will-dismiss-qui-tam-caseslacking-merit. 2 31 U.S.C. § 3729 et seq. 3 See Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Recovers Over $4.7 Billion from False Claims Act Cases in Fiscal Year 2016 (Dec. 14, 2016), https://www.justice.gov/opa/pr/‌justicedepartment-recovers-over-47-billion-false-claims-actcases-fiscal-year-2016 . 4 Fraud Statistics Overview (Dec. 13, 2016), https:// www.justice.gov/opa/press-release/file/‌918361/ download. 5 See False Claims Act Cases: Government Intervention in Qui Tam (Whistleblower) Suits. United States Department of Justice, available at https:// www.justice.gov/sites/default/files/usao-edpa/ legacy/2012/06/13/InternetWhistleblower%20 update.pdf 6 Id. 1

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J. Matthew Kroplin is a partner in Burr & Forman’s Nashville office, practicing in the firm’s healthcare and business litigation sections. Adam W. Overstreet is counsel in Burr & Forman’s Birmingham office, practicing in the firm’s healthcare section, and is a former Assistant United States Attorney.

GRAND ROUNDS Mark Your Calendars TNA Legislative Summit • April 4 More than 1,000 nurses and nursing students are anticipated to attend the Tennessee Nurses Association annual Legislative Summit at the War Memorial Auditorium. For details and registration, go online to tnaonline.org. Music City SCALE • May 9-12 Hosted by the Tennessee Society for Laser Medicine and Surgery, the 13th Annual Symposium for Cosmetic Advances & Laser Education (SCALE) is set for May at the Music City Center. For more information on speakers, CME, and registration, go online to tnlasersociety.com

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GRAND ROUNDS

Tempus, a technology company focused on helping doctors personalize cancer care by collecting and analyzing large volumes of molecular and clinical data, and Vanderbilt-Ingram Cancer Center (VICC) have announced a new collaboration to improve outcomes for cancer patients. As part of the initial research project, Tempus will use its Tempus O platform to ingest and structure clinical data from the cancer center’s electronic health record. Tempus also will provide next generation sequencing and analysis for a subset of patients in order to identify actionable gene alterations. Datasets often are small and sometimes disorganized. In order to usher in the age of precision medicine, Tempus built a series of data pipelines to collect, cleanse, and analyze data, at scale. “Empowering Vanderbilt-Ingram researchers and physicians with data, tools and evidence to help inform care and accelerate discoveries that benefit patients is a top priority,” said Jennifer Pietenpol, PhD, executive vice president for Research at Vanderbilt University Medical Center and director of VICC. “Collaborating with Tempus will allow the Vanderbilt-Ingram team to gain Dr. Jennifer a deeper understanding Pietenpol of a patient’s cancer and its genetic and molecular drivers with a goal of improving patient outcomes.”

Frost-Arnett, HealthiPASS Form Strategic Alliance

Last month, Nashville-based Frost-Arnett, a large national player in accounts receivable management (ARM) for the healthcare industry, announced a strategic alliance with Illinois-based HealthiPASS, a revenue cycle solution that helps assure and accelerate collec-

tions while bringing price transparency to the patient payment experience. Officials with the two companies said the alliance adds an important front-end accounts receivable patient payment solution to Frost-Arnett’s business services portfolio and introduces HealthiPASS to a qualified healthcare national provider network seeking to reduce bad debt and fast-track revenue collection. The alliance supports Frost-Arnett’s pursuit to help clients with the increasing challenge of resolving patient balances in the wake of increased prevalence of high deductible health plans and out-of-pocket financial responsibilities for consumers. “The HealthiPASS solution is complementary to our core services,” said Jason Meyer, CEO of Frost-Arnett. “We will now be the only ARM company that provides a true end-to-end suite of solutions for resolving the patient-pay portion of healthcare from check-in through delinquency.” HealthiPASS features self-service patient check-in and check-out; real-time insurance eligibility verification; instant patient visit cost estimates; automatic collection of prior balances, copays and pre-service deposits at check-in; and automatic collection of patient balances after insurance payment without paper statements or harsh collection practices.

Hill Named President of Peak Health Solutions

Brad Hill has been named president of Peak Health Solutions, Inc., a midrevenue cycle solution provider for acute care and physician practice markets. Peak Health Solutions, which moved from headquarters from San Diego to Franklin in 2014, is an AMN HealthBrad Hill care company. Hill has more than two decades of healthcare leadership experience, primarily in revenue cycle technology and services for both payers and providers.

Most recently, Hill was chief revenue officer at healthcare technology company RemitDATA. Prior to that, he served in senior management roles with Payer Solutions for Passport Health Communications / Experian Health, Parity, HMS, and AIM Healthcare. He earned his degree in business with an emphasis in accounting from Murray State University.

Baird Named TMA Director of Insurance Affairs

Karen Baird, CPC, CPMA has joined the Tennessee Medical Association as director of Insurance Affairs and will serve as the organization’s in-house expert on federal and state health insurance poli-

cies and reform. She will be responsible for commercial and government health insurance plan relations, provide informational and policy assistance to advocacy and Karen Baird education staff and help TMA member physicians resolve payer-related administrative and reimbursement hassles. Baird brings more than 30 years of healthcare administrative experience to TMA, most recently as office manager with Midtown Primary Care Clinic in Nashville. She is a certified professional coder and medical auditor.

TriStar Skyline Debuts Robotic Spine Surgery Technology

Officials with TriStar Skyline Medical Center announced they have become the first hospital in Middle Tennessee to add the Mazor X surgical assurance platform to its orthopedic and spine surgery program. The Mazor X system combines preoperative planning tools with guidance during surgeries for adult spine patients. As spinal surgery has evolved, more focus has been placed on minimizing trauma to the body during surgery and expediting a return to function through the use of minimally invasive techniques. The Mazor X system utilizes a 3D comprehensive surgical plan and analytics that provides critical information prior to surgery to enable the surgeon to operate with greater precision, efficiency and confidence.

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 FEBRUARY: Michele Johnson, co-founder and executive director of the Tennessee Justice Center, shares information on the “Insure Our Kids!” campaign, which brings together healthcare and children’s services organizations and resources to make sure every eligible child in Tennessee has access to the coverage and care they need to grow up healthy. Patrick Ryan, MD, FACS, a board certified vascular surgeon and founder of Nashville Vascular and Vein Institute, discusses open vs. percutaneous interventions in his piece: “Minimally Invasive Surgery is Here to Stay. Is Open Vascular Surgery Still Necessary?” Ryan, who has a particular interest in critical limb ischemia, aneurysm and carotid disease, looks at the pros and cons of both open and minimally invasive vascular surgery for limbthreatening ischemia. Arthur Van Buren, shareholder-in-charge of LBMC’s healthcare tax practice shares information on a reprieve that accompanied the recent federal shutdown in “Side Benefit from Government Shutdown: Funding Bill Delays Health-Related Taxes”

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PHOTO: ©2014 Steve Widoff

VICC, Tempus Launch Data Initiative to Improve Outcomes


GRAND ROUNDS STMP Celebrates New Sites, Staff It’s been a busy couple of months for Saint Thomas Medical Partners with new leadership, facilities and physicians coming on board. In late November, Yvette Doran was promoted from chief operating officer to president and CEO of Saint Thomas Medical Partners, one of the region’s largest medical groups. Last month, Beth Van Gilder was announced as the new COO. She initially joined STMP in early 2017 as executive director of Care Delivery Operations, a role dedicated to supporting practice operations in the transition to value-based care. Previously, Van Gilder was vice president of Physician Services for Northwest Health System in Bentonville, Ark. The new Franklin Care Center celebrated a grand opening on Jan. 29. A few days earlier, on Jan. 26, the McMinnville primary care site opened with Alma Tamula, MD, as a new physician partner. Tamula, who is board certified in family medicine, graduated Dr. Alma Tamula with honors from the University of the Philippines before earning her medical degree at University of the East Ramon Magsaysay Memorial Medical Center and was one of the chief residents during her time in the Family Medicine Residency Program at Howard University Hospital in Washington DC. Patrick Saitta, MD, a gastroenterologist specializing in gastrointestinal cancers and pancreaticobiliary disorders, has joined STMP at both the Nashville and Lebanon locations. Dr. Patrick Saitta He earned his undergraduate degree in microbiology and his medical degree from LSU, where he was a member of Alpha Omega Alpha Medical Honor Society. Saitta completed a residency in internal medicine at Mount Sinai Hospital in New York City and his gastroenterology fellowship at LSU, followed by an advanced endoscopy fellowship at Lenox Hill Hospital in New York City. He holds board certification from both the American Board of Internal Medicine and the American Board of Gastroenterology. David Bauman, MD, a primary care physician specializing in family medicine, has joined STMP – New Salem. He earned his undergraduate degree at Penn State and his medical degree from Jefferson Medical College, Thomas Jefferson University. Bauman com- Dr. David Bauman pleted residency in family medicine at the University of North Carolina at Moses H. Cone in Greensboro, NC. Before relocating to Nashville, he spent more than three decades in

family practice in New Jersey. Diana Sepehri-Harvey, DO, a primary care physician board certified in family medicine with specialization in osteopathic manipulative treatment (OMT) and integrative medicine, has joined STMP in Franklin. Sepehri-Harvey earned her undergraduDr. Diana ate degree from Bates Sepehri-Harvey College, where she graduated magna cum laude. She completed a Master of Arts in Medical Anthropology and a Master of Public Health, both at Case Western Reserve University, and earned her medical degree from Touro University College of Osteopathic Medicine. Sepehri-Harvey then completed residency at Loma Linda University. She is fluent in English, Spanish and Farsi.

Awards, Honors, Achievements

Nashville-based Change Healthcare has earned top rankings in the 2018 Best in KLAS Awards: Software & Services annual report, including one “Best in KLAS” designation in the payer quality analytics segment and two “Category Leader” designations for the scheduling nurse and staff segment and for the healthcare price transparency segment. Saint Thomas Rutherford Hospital officials recently announced the 2017 physician awards with Peter DiCorleto, MD, being named Physician of the Year; James Boerner, MD, receiving the Clinical Excellence award; and Tom Johns, MD, receiving the Olin Williams Distinguished Service award. Vanderbilt University Medical Center is the first health system in the nation to receive the Association for Professionals in Infection Control and Epidemiology (APIC) Program of Distinction designation, an acknowledgement of excellence for infection prevention and control programs that meet stringent standards established by the association. APIC is the leading professional association for infection preventionists (IPs) in the country, with more than 15,000 members. BlueCare Tennessee is the first managed care organization in the country to earn Distinction Status from the National Committee for Quality Assurance (NCQA) in Long-Term Services and Supports (LTSS). NCQA’s LTSS Distinction supports health plans in developing best practices for person-centered care planning and effective care transitions, and for measuring quality improvement to support people living optimally in their preferred setting.

CALL FOR NOMINATIONS Our annual Women to Watch issue is coming in May 2018, and we want your input on women in Middle Tennessee impacting healthcare at home and beyond. Help us honor clinicians, researchers, administrators, policy makers, and other industry experts by nominating these outstanding professionals.

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