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Genetics Providing Key Information in Fight Against Cancer At one time, a lab-examined resection of tissue on a slide would report only malignancy and cancer stage. Now, thanks to genetic advances, the analysis can give clues to the cancer’s own destruction, according to Kenneth Groshart, MD, a pathologist at Trumbull Laboratories, LLC. ... 4

Child Life Specialists at St. Jude Tackle the Toughest of TasksAnd you thought your job was challenging.

Child Life specialists at St. Jude Children’s Research Hospital are publishing research in an area where virtually none exists, while tackling the toughest of topics with children and teens ... 6

FOCUS TOPICS ONCOLOGY TRANSPARENCY CLINICAL TRIALS

In Case of EmergencyTennessee Department of Health’s Role in Protecting the Population

By SUZANNE BOyD

Nick Lewis took over the reins at Hardin County Medical Center in March 2013 bringing with him more than 25 years of experience in the healthcare arena. From respiratory therapist to consultant to chief fi nancial offi cer, Lewis brings a vast knowledge with him along with a heart to make an impact on the quality of care delivered.

Lewis, who hails from Louisville, Kentucky, at-tributes his desire to pursue a career in health-care, albeit originally on the clinical side, to his personal knowledge of the fi eld gained by having a father who was totally disabled.

Lewis started his career as a respiratory ther-apist in Kentucky. After working for six years he moved to North Carolina to run the respiratory

(CONTINUED ON PAGE 8)

HealthcareLeader

Nick LewisChief Executive Offi cer, Hardin County Medical Center

By CINDy SANDERS

Between immunizations, primary care ser-vices, licensure and regulation of health facilities, analyzing health statistics and launching preven-tive care initiatives, it’s easy to think of the Tennessee Department of Health as more ‘Clark Kent’ than ‘Superman.’ Yet, as the recent multi-state fungal meningitis outbreak clearly reminded us, addressing emergency situations is a key part of the TDH’s core func-tion.

In fact, the department was pri-marily established to combat life-threatening outbreaks of cholera, yellow fever and other deadly diseases in the late 1880s. Pre-venting or stopping public health threats remains a top priority. Sometimes those threats warrant local, state or national at-tention, but often the TDH staff quietly goes about that part of their workday with-out much fanfare.

“Our mission is to protect, promote and improve the health

and well-being of Tennesseans. The emergency preparedness aspect is all about protecting the population,” noted TDH Commissioner John Dreyzehner, MD, MPH.

The types of emergencies range from natural or manmade disasters to addressing or preventing communicable and infectious dis-

eases to investigating outbreaks. “We

take an all haz-ards approach,” e x p l a i n e d

Dreyzehner. “We never know when the

next event will be … but we know it’s coming.”With the State Public Health Lab-

oratory in Nashville and additional labs in east and west Tennessee, the TDH has approximately 130 staff

members who perform close to 1.5 mil-lion lab tests annually. Not only do the labs

have the ability to run a broad spectrum of health assays, the staff also is called upon to analyze substances of concern, such as an


2 > SEPTEMBER 2013 w e s t t n m e d i c a l n e w s . c o m

It was about 10 years ago when The Jackson Clinic began a new clinical research endeavor. The desire was to offer physicians the opportunity to collect data which would help establish new treatments for medical problems. This differs from standard clinical practice in that standard practice uses treatment already established. This also offers patients the opportunity to receive cost-free, cutting-edge treatments, hope for relief of their conditions which have not responded to established treatments, help with the development of new therapies, and receive additional care and attention from the clinical trial staff. Research may involve development of new drugs; new uses and indications for established drugs, devices, surgical procedures, and testing. There is an established process through which new therapies undergo in order to become approved therapies. For drug therapies, this may start in the laboratory, then progress to studies involving very small numbers of people to test for safety, then to studies involving slightly larger numbers of patients at a therapeutic dose to test for effectiveness, then on to large numbers of patients to determine therapeutic effect and to get FDA approval. Occasionally there will be further studies involving post marketing surveillance to watch for long-term effects. The stages of drug development are referred to as phases, Phase I, Phase II, Phase III, and Phase IV. Phase II is frequently broken down to Phase IIa and Phase IIb, where IIa assesses dosing requirements and IIb randomizes patients to either placebo or standard treatment. The Jackson Clinic participates predominantly in large multicenter trials involving large numbers of patients determining therapeutic effect, which is Phase III. Trials we have participated in have resulted in new therapies and vaccines which are now on the market and part of standard clinical practice.

An essential for successful clinical research trials is patient recruitment. This is accomplished in several ways including general clinical practice patients, advertising, and word-of-mouth. Some patients have concerns about participation, feeling that they may be involving themselves in experimentation. Nothing could be further from the truth as patient safety, including their complete informed consent, is paramount in clinical research. There were times in the distant past where this was not the case, and occasionally grave injustices were done. Now there are guidelines for patient safety which are established both nationally and internationally. Researchers are required to have training in procedures maximizing patient safety, generally referred to as GCP, or good clinical practice. Use of GCP will be part of the contract with the sponsoring company in order to conduct a trial. Patients can therefore be reassured that their safety is the prime consideration, and they can completely voluntarily choose to participate, or withdraw if they desire, once they have been completely informed of what they will be involved

in doing and given their consent. Informed consent is another essential part of clinical research. Once a patient is enrolled in a trial, their evaluation and treatment will be free of charge and their time and effort are usually compensated with a patient stipend.

Physician participation from the Clinic has been primarily from OB/GYN, Internal Medicine, Pediatrics, and Family Practice over the past several years. In February 2013, an addition was made to the research team to include the Cardiology Department. We feel this will be a great benefit and service to our Jackson Clinic patients. The Jackson Clinic Research Department is currently conducting a wide variety of clinical trials. For more information about clinical research, please visit us on the web at http://www.jacksonclinic.com/clinical-research.html . Being able to offer Clinical Research to our patients and community is just one of the many ways “We Specialize in You.”

Clinical Trials Are Safe, Cost-Free And Offer Advantages To Participants

By Dr. William P. Stepp, Jr.

Pediatric Department2863 Hwy 45 ByPass

www.jacksonclinic.com • 731-664-1375

w e s t t n m e d i c a l n e w s . c o m SEPTEMBER 2013 > 3

By SUZANNE BOyD

With the opening of the new Kirkland Cancer Center on the Jackson campus of West Tennessee Healthcare (WTH) in December, Jeff Kovalic, MD, will not only re-locate to the spacious 85,000 facility but will also have access to the latest technol-ogy available for the treatment of cancer. As medical director for WTH’s radiation oncology program for more than 20 years, Kovalic is excited at the prospect this new chapter in the delivery of cancer treatment holds for patients across West Tennessee.

The Chicago native said the new cen-ter is the culmination of many who had an input in the design of the facility as well as the services that would be housed there. “It was a phenomenal process that was spearheaded by Gina Myracle, executive director of the Kirkland Cancer Center,” said Kovalic. “I got to give my input on the center, but there were many people who came together through many stages in the design of this remarkable build-ing. The biggest contribution that I make to the center is not with its design but in my broad experience as a clinician.”

The focus of the center, which was made possible through a donation by Alice and Carl Kirkland, is on ease of ac-cess to care for patients, family members and caregivers, in comfortable surround-ings. All oncology services and resources needed by a cancer patient, whether they are a newly diagnosed patient or a long time survivor, will be readily available. One of the biggest challenges was to de-sign a building that lives up to all that is needed today as well as in the future.

“The multi-story facility will house the radiation oncology department on the first floor and will include three lin-ear accelerators. One will be a state of the art linear accelerator, which will provide more options, and capabilities of treat-ment types for the administration of radia-tion therapy than are currently available in the area,” said Kovalic. “Two of our current linear accelerators will be relo-cated from the hospital in phases so that there is no interruption in services to our patients. Having three accelerators will allow us to see more patients in a timely manner. Most free standing facilities such as ours only have one accelerator.”

Kovalic says the relocation will take place over a weekend. “We are one of the busiest radiology departments in the state so we cannot miss a beat. We will treat cancer patients as normal in the hospital until the end of the day on that Friday. Then will make the big move over the weekend,” he said. “On Monday morn-ing, we will open as normal in our new facility and continue to provide the qual-ity patient care we are known for. We will offer complete radiation therapy services for all adult malignancies, as we have

been. This includes radiation implants, stereotactic radiosurgery and the adminis-tration of radiopharmaceuticals. We have treated kids on rare occasion but they gen-erally go to St. Jude.”

Kovalic always knew he wanted to be a doctor due to his fascination with all things about humans and the human condition. After graduating from Loyola

University in Chicago with a Bachelor of Computer Science and Mathematics, he earned his medical degree from the Medi-cal College of Wisconsin in Milwaukee. In his first year he realized oncology was the specialty for him. “I love cancer patients,” said Kovalic. “They do what you ask them to do and although it can be a potentially deadly diagnosis, there is still so much you can do for the patient.”

After spending his transitional year completing an internship at St. Joseph’s Hospital in Milwaukee, Kovalic com-pleted his radiation oncology residency and a one-year fellowship at Washing-ton University in St. Louis, Missouri’s Mallinckrodt Institute of Radiology. “It was one of the top training programs in this specialty,” said Kovalic. “It is a high powered program and I was privileged to serve as chief resident in it so I came out with lots of experience. I initially consid-ered taking an academic track for my ca-reer but I really enjoyed private practice because it allows you to center your time on the care of patients.”

Having grown up in Chicago, Kovalic knew what big city life meant and since he had two small kids to factor into his de-cision he was drawn to the pace Jackson had to offer coupled with its vast medical community. “I was amazed at the medical services offered in a town this size,” said Kovalic. “And my wife Pam and I knew

it was the place for us to raise our family.”In 1991, Kovalic joined the staff of

Jackson Madison County General Hospi-tal and by 1992 he was medical director for the radiation oncology department. “As medical director, I have been able to put my mark on things for over 20 years and been able to help guide the depart-ment in the way it has headed,” said Kovalic. “The department has an excel-lent reputation for delivering good care and we have always ranked high in patient quality surveys.”

An avid basketball player who has a full court in his backyard, Kovalic has the reputation around town as a basketball fa-natic who plays regularly. As his kids grew up, Kovalic was a hand’s on father, coach-ing PAL basketball among other sports as well as serving as his son Alex’s Cub and Boy Scout Leader. Pam was also active in their kid’s lives and has continued to work each week as a volunteer in the Lower School Library at University School of Jackson for more than 20 years.

With Alex starting his second year of medical school at UT- Memphis Health Sciences Center and daughter Calli in her second year of law school at Loyola University in Chicago, the Kovalics have plenty of time to indulge in one of their shared favorite pastimes, hiking. Kovalic is also a competitive chess player who ranks in the top five percent in the country.

Jeff Kovalic, MDRadiation Oncologist, Kirkland Cancer Center, West Tennessee Healthcare

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Genetics Providing Key Information in Fight Against Cancer

By GINGER PORTER

At one time, a lab-examined resection of tissue on a slide would report only ma-lignancy and cancer stage. Now, thanks to genetic advances, the analysis can give clues to the cancer’s own destruction, ac-cording to Kenneth Groshart, MD, a pa-thologist at Trumbull Laboratories, LLC.

Since the full sequence of the human genome was completed and published in April, 2003, an explosion of applications to all varieties of tumors has emerged.

“The forefront of cancer diagnosis and therapy is in the realm of molecular genetics to find out what makes cancer cells different from normal cells,” Gro-shart said. “Our primary job is to identify all the different cancer types and try to get to know which have usable molecular tests and can be addressed with targetable agents.”

The tumor panels Trumbull selects are from nationally recognized molecular genetic laboratories. They are designed primarily to identify what molecular path-ways of growth, proliferation, differen-tiation and specialization are activated in the tumors and how they compare with normal tissue. Research has identified sev-

eral tumors with abnormally turned “on” pathways. A few targetable biological agents have been developed to attach to the cells and turn off abnormal pathways, ceasing proliferation and growth.

“This will hopefully make the tumor shrink and allow the body’s immune sys-tem to make it disappear with standard chemotherapy or make the tumor more

amenable to standard chemotherapy,” he said.

According to Groshart, the role of the pathologist is to give the most information to the medical oncologist as soon as pos-sible so they can customize treatment op-tions.

“After a tumor is excised by a sur-geon,” he said, “the next visit a patient has

is with the medical oncologist. Why waste a medical oncology visit? Otherwise that puts the patient another few weeks down the road before they can get therapy.”

In some instances, as with melanomas and lung cancers, the tumor often gets re-sistant to the targeted agent. While the drug is working, it is more effective than chemotherapy, and the patient has fewer side effects. “The promise of the therapy is so strong that people are trying to de-velop drugs in these multi-step pathways to block the multiple steps,” Groshart said. “Then one can use these drugs sequen-tially or in combination.”

Another cancer test available through Trumbull is the Oncotype-DX® test, which through molecular analysis explains how aggressive a breast tumor with estro-gen receptor is, predicting its propensity to recur over the next three years. Special breast cancer staining has been available for many years to help predict responsive-ness to breast-specific interventions. The stains determine whether the tumor is HER2-neu receptor, estrogen receptor or progesterone receptor positive.

For example, if the patient is posi-tive for HER2-neu, she is a candidate for



Atrial fibrillation (AF) is a supraventricular tachycardia with disorganized, chaotic atrial activation. It is an irregular rhythm that causes decreased atrial mechanical function. It is diagnosed by its characteristic ECG findings. The P waves are replaced by fibrillatory waves which vary in size, shape, and timing. The ventricular rate depends on AV conduction, autonomic tone, presence of an accessory pathway, and medication. The ventricular rhythm is usually irregular, but it may be regular if there is AV block with ventricular pacing. Also, a competing junctional or ventricular tachycardia may result in a regular ventricular rhythm if the tachycardia is faster than atrial fibrillation conducting through the AV node. A wide complex tachycardia that is fast and irregular may represent atrial fibrillation with conduction down an accessory pathway. Alternatively, this scenario may represent polymorphic ventricular tachycardia or atrial fibrillation with aberration. It is important to differentiate atrial fibrillation from other supraventricular tachycardias, such as atrial tachycardia, atrial flutter, atrioventricular nodal re-entrant tachycardia, and atrioventricular re-entrant tachycardia. These tachycardias may cause patients to experience similar symptoms, but the underlying mechanisms, prognosis, and treatment options are different. AF may be diagnosed using many different modalities, such as an ECG, holter monitor, event monitor, implantable loop recorder, or telemetry tracings. Intracardiac electrograms from pacemakers, defibrillators, or an electrophysiology study may also be diagnostic.

AF is the most common arrhythmia. It affects more than 2.2 million people in the United States. In the past 20 years hospitalizations have increased by 66%. The incidence increases with age. Less than 0.1% of people less than 40 years old have the diagnosis, but women develop AF 1.5% per year and men 2% per year when they are older than 80 years of age. Approximately 70% of the patients with AF are between 65 and 75 years old.

The underlying mechanism of AF is not clearly known. Multiple possible mechanisms, however, have been proposed. These include focal triggers, re-entry, multiple random wavelets, rotors/spiral waves, fibrillatory conduction, complex fractionated electrograms in the left atrium, and alternations in the autonomic nervous system via the ganglionic plexi. The triggers may originate from the pulmonary veins, Ligament of Marshall, left posterior wall, coronary sinus, or superior vena cava. The multiple wavelets depend on conduction velocity, the refractory period, and a critical mass of tissue.

Electrical and structural remodeling occur in the left atrium. The refractory period shortens, the conduction velocity slows, and the chamber dilates. Atrial fibrosis causes non-homogenous conduction. There is also a loss of overall mass. Sinus node dysfunction and AV block may occur as well. The left atrium accommodates to the rapid, irregular activity of atrial fibrillation and makes the continuation of AF more likely. This supports the natural progression of AF from paroxysmal to persistent to permanent. Thus, “AF begets AF.”

It is helpful for management purposes to describe the frequency, or overall burden, of AF. The initial episode is classified as the first episode. Recurrent episodes are classified as paroxysmal, persistent, long standing persistent, or permanent. Paroxysmal episodes terminate

spontaneously within seven days. Persistent episodes last more than seven days or require termination. Long standing persistent episodes last more than a year. Permanent AF refers to the clinical situation where cardioversion has failed to restore sinus rhythm or a decision has been made to no longer attempt to restore sinus rhythm.

AF is often associated with other comorbidities. Some of these include increased weight, valvular heart disease, heart failure, coronary artery disease, hypertension, hypertrophic cardiomyopathy, congenital heart disease, and obstructive sleep apnea. There is also occasionally a familial component.

AF can also be transient and secondary to an underlying condition. Examples include acute myocardial infarction, cardiac surgery, pericarditis, myocarditis, hyperthyroidism, pulmonary embolism, pulmonary disease, other arrhythmias, sleep deprivation, emotional stress, trauma, pheochromocytoma, alcohol, stimulants, and infection.Lone AF refers to the clinical scenario where the patient is less than 60 years old, and there are no other significant comorbidities. Specifically, there is no cardiac, pulmonary, or vascular disease. There is no hypertension or diabetes. There has not been a previous transient ischemic attack or stroke.

Patients may experience a number of symptoms, or they may not notice any symptoms. Common symptoms include palpitations, fatigue, weakness, dyspnea on exertion, light headedness, chest discomfort, polyuria, and an overall decreased quality of life. Syncope is occasionally associated, such as after a prolonged post-conversion pause from AF to sinus rhythm.AF is associated with an increased risk of stroke, heart failure, and all-cause mortality. The mortality risk is linked to the severity of the underlying cardiovascular disease. AF has been a strong, independent risk factor for increased morbidity and mortality in large heart failure trials. The stroke risk has been estimated at 5% per year for non-valvular AF. It is important to note, however, that this risk varies with age and other comorbidities, such as heart failure, hypertension, diabetes, previous stroke/TIA, vascular disease, and gender. The stroke risk may be 1.5% per year for a patient with no significant comorbidities in his or her 50s, but it may be 23.5% per year in a patient with other comorbidities in his or her 80s. The risk of stroke is two to seven times greater for comparable patients with non-valvular AF. The risk of stroke is increased 17 times if a patient has rheumatic heart disease. One in six strokes occur in patients with AF.

Management strategies depend on how the rhythm is affecting the patient. The severity, duration, and pattern of symptoms should be considered. Associated comorbidities may be exacerbated by the arrhythmia, but they also may contribute to episodes of AF. Also, some patients are more susceptible to a reduction in overall cardiac function and efficiency while others are not. It is important to discuss the risks and benefits of anticoagulation to lower the chance of thromboembolic phenomenon. It

is noteworthy that the risk of stroke and the decision to anticoagulate is based on the underlying comorbidities and not on whether or not the patient is currently in sinus rhythm. The CHADS2 or CHA2DS2/VASc scoring systems can help guide this decision. This risk of anticoagulation, however, should also be considered. Patients with underlying bleeding tendencies, balance difficulties, recent syncope, or trouble maintaining a consistent medical regimen may be at increased risk for hemorrhagic complications.

There are many options for utilizing either a rate or rhythm control approach. Potential strategies include observation, medical therapy, electrical cardioversion, pacing support, and ablative therapy. Some patients do well with a rate controlling approach despite continued AF. Other patients feel poorly due to underlying AF despite adequate rate control. Some patients have adequate rate control without further medication and do not seem to be bothered by the underlying AF. These patients may not need medications or procedures for controlling the rate or rhythm, but they still need to address anticoagulation. The management of AF changes over time depending on a patient’s clinical course and the efficacy of current treatment options.

329 Coatsland Dr • Jackson TN 38301 heartrhythmclinic.wth.org • (731)424-5080

Never Missing A Beat, Keeping Your Heart In RhythmBy Dr. Shawn Baldwin


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By JONATHAN DEVIN

And you thought your job was chal-lenging.

Child Life specialists at St. Jude Chil-dren’s Research Hospital are publishing research in an area where virtually none exists, while tackling the toughest of topics with children and teens.

“From the time a child (patient) walks in the door, we teach them about their diag-nosis in an age-appropri-ate way,” said Shawna Grissom, MS, CCLS, CCIM, director of Child Life at St. Jude. “We ex-plain what blood is, what cells are. Sometimes it’s tougher discussions about the journey of life, like ‘do I want to continue treatment’ and ‘what happens if I don’t?’”

Sometimes the discussion is ‘what would you like to have at your funeral?’

The Child Life department morphed out of a structured play program at the hospital about 17 years ago. Grissom’s staff of 20 specialists is nationally-certified and has a minimum of a bachelor’s degree in child development or human develop-ment.

Each carries a case load of upwards of 200 patients, usually in the same age group, who visit the hospital throughout the year for treatment. In one day they work with ten to 20 patients ranging from infants to teenagers.

Play is at the heart of self-expression and understanding for the younger chil-dren.

“Play is the foundation of a lot of what we do,” said Grissom. “We focus about half of our practice on play. That’s where we get children to express them-selves, through play.”

For example, specialists might ma-nipulate a doll with real or play medical supplies, which is easier than asking pa-tients about their feelings verbally.

“I can get them to express themselves through play and a few minutes later they may open up and talk about their treat-ment or a surgery,” said Grissom.

Play is also important to help children socialize, which keeps them from regress-ing developmentally due to the stress of treatment.

“We’re working with children to help them cope with the hospital setting, be-cause a hospital setting is not normal for them,” said Grissom. “We’re trying to help them gain trust and confidence as well as to gain mastery for skills in life.”

For example, a child who has a port installed under the skin for chemotherapy needs to know why the port is there and how to get through the discomfort of hav-

ing it accessed.“Children need to learn skills like

deep breathing, body relaxation, and guided imagery,” said Grissom. “We can also do sensory simulation. Sometimes it’s as easy as having a movie that they’ve not seen before.”

Teenagers have resources for expres-sion like Real Talk sessions in which spe-cialists guide discussions like “why did this happen to me” or what life might be like when you know the benchmarks of adult-hood are not in your future.

They also have special teens-only rooms and access to artists, videographers, and sound recording engineers who give them an outlet for feelings, journaling, and leaving behind a legacy.

“Even as adults we have misconcep-tions about what is happening, what’s going to happen, or what’s wrong with us,” said Grissom. “We try to give (pa-tients) the right answers and alleviate those fears. If we can give them the right information we find that their fears and stress levels tend to decrease. (The treat-ment) still might hurt, but how do you get through it successfully?”

Over the years Child Life has built up a body of information about exactly how that happens, which they are now publish-ing.

The department’s first research study, published in Aug. 2012, was titled “In-tervention helps children with sickle cell disease complete MRI tests without seda-tion.”

In it, 71 sickle cell patients ages five to 12, who participated in a short prepa-ration program prior to having an MRI were found eight times more likely to com-plete the scan without needing sedation.

The study was published in Pediatric Radiology.

Typically, MRI patients must be se-dated during an MRI and they must stay the night before in the hospital. Child Life’s preparation program, which in-volves education and assigned tasks during the procedure to help them remember to stay motionless, reduces stress and anxiety for the child and represents cost-savings to the hospital.

Child Life has also published an ar-ticle about its Legacy Bead program in which patients add colored, glass beads to a string, each one representing a piece of their journey from “learning to take medi-cine,” to “homesickness,” to a “losing my hair,” to the silver bead which means “no more chemo.”

The program became so popular that a similar one was created for siblings of patients.

Currently there are two Child Life studies underway, one which studies patients’ perspectives on learning their

Child Life Specialists at St. Jude Tackle the Toughest of Tasks

Shawna Grissom



By TIM NICHOLSON

In the 2000 film, “What Women Want,” Mel Gibson plays the part of a sex-ist guy working in an ad agency. He suf-fers a sort of semi-electrocution. Instead of killing him, it gives him a super power. He’s suddenly able to hear what women are thinking! As such, he can better connect his marketing messages (and a few other mes-sages – but that’s a different sort of article) to their thoughts. Pretty powerful stuff, huh?

The movie is full of marketing lessons – even for us, Doc. After all, we know that women influence many of the healthcare decisions in a family. They typically sched-ule the appointment for their husbands, they definitely plan out the health services for their children, and they’re also taking care of their aging parents.

Among other things, the film reminds us that a consumer’s buying behavior is largely driven by irrational fears, frustra-tions, hopes and volatile emotions. It’s that way with patients, too.

So, how do you address that? You pin. Specifically, you join the popular social media site known as Pinterest and develop community around it.

Why? Well, first, because women are there. Here’s a little science for you – 80 percent of Pinterest users are females (mostly adults) and half of them have chil-dren.

The director of communications for the Ovarian Cancer National Alliance says that, for her, “The tipping point with Pinter-est was when I noticed that people were ac-tually pinning images from our [web] site.”

Teaching Moment Doc, pinning means that the web-

site user is choosing an image from your page to share with her friends on Pinterest. Think “liking” on Facebook but with pic-tures. Lots of pictures.

She added, “I can see that our com-munity is actually using this and they are finding visuals that they want to share… (we decided that we need to) make sure that we’re part of that conversation.” You should too. They’ve been on Pinterest now for over a year.

Still, that’s just a place right? Sort of. It’s also a state of mind.

Virtually all advertising appeals to emotion instead of logic because emotions are far more powerful when it comes to in-fluencing behavior.

In the film’s climactic scene, the Nike pitch, we saw how specific we have to be in addressing the fears, frustrations, and emo-tional impulses of the women with whom we hope to connect.

But how can we find out what these often hidden emotions and irrational fears are? First, you gain trust. Eighty percent of the women using Pinterest say they trust it. It’s likely that you can become part of that trusted community. But first, you’re going

to have to do some pinning. You can start by knowing what’s pop-

ular and how it relates to your specialty. The top five subjects on Pinterest re-

volve around Home, Arts, Style/Fashion, Food, and Inspiration with a strong surge related to Health/Fitness. And there’s a conversation, largely in the form of pin-ning items that others have curated, in-viting others to pin to your board, and following people or brands that pin things that resonate with you.

How do these top five subjects relate to health?

• Home – Women living with chil-dren, aging parents, or disabled family members want to make a safe, livable space without compromising style. They pin.

• Arts – What about images that soothe a discomforted soul or a recovering patient? Pin some.

• Style/Fashion – Hey, not every-thing is science here, but I’ve seen pins of maternity fashion or things women might aspire to wear that would help inform some of the healthcare decisions. Find someone pinning those and re-pin them.

• Food – Recipes rule on Pinterest. Almost any medical condition can be af-fected in a positive way through a healthy diet. Do you know the foods that might whet the appetite of your patient and help her to achieve a healthy lifestyle? Pin some.

• Inspiration – Maybe it’s scripture. But it could be images. Nature inspires. Movies inspire. Heroes inspire. Offer your patient an ideal to pursue by pinning about it.

• Health/Fitness – Like food, there are few health conditions that aren’t im-proved by regular diet and exercise. Pin some tips.

Hey Doc, this may sound a bit crazy but marketing is full of crazier stuff than this. Imagine what thoughts you would hear from Pinterest users. If you’re pin-ning, then you’re part of the conversation. And when you re-pin or invite others to pin with you, you just might start hearing what women want.

Hey Doc, What Do Women Want?

Tim C. Nicholson is the President of Bigfish, LLC. His Memphis-based firm connects physicians, clinics and hospitals to patients and one another through healthcare social media solutions, branding initiatives and websites. His column, “Hey Doc”, appears here monthly. Find him on twitter @timbigfish or email [email protected]

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benefit. To do that, we’ve sponsored and published a variety of

papers like the one written by Physicians Practice magazine:

What Every Doctor Should Know About Hospice.

4992_Facts_MEM_MedNews_4.875x13 2/8/13 10:48 AM Page 1


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therapy department of a small community hospital, his first taste of the management side of healthcare. Realizing that he needed to round out his education beyond the clin-ical side, Lewis decided to go back to school part time while he ran the department. He earned a Bachelor’s degree in Business Ad-ministration from the University of North Carolina at Greensboro then in 1985 de-cided to pursue a graduate degree full-time. He earned his Master’s of Healthcare Ad-ministration degree with a concentration in finance and accounting from Ohio State University in 1987.

“I decided to go to graduate school in order to be more well-rounded. I had the clinical background but knew I needed to bump up on the financial and accounting sides,” said Lewis. “As a manager, I needed to have both clinical and financial experi-ence to better understand both sides.”

Rather than going straight into the hospital setting, Lewis took a consulting position with Arthur Anderson in Tampa, Florida. “I took the position as I saw it in order to get a broad base of experience. I was a healthcare consultant but also did auditing,” said Lewis. “I went as a clinical person but only got one healthcare project in the year I was there so I knew it was time to start looking.”

Lewis headed to Beckley, West Vir-ginia, to take on the role of assistant ad-ministrator and financial officer for the non-profit Appalachian Regional Health-care facility. His responsibilities over his five-year tenure at the 173-bed facility that had an average daily census of 110 included all of the financial side of the hos-pital with the exception of general account-ing. His first chief executive officer position was within the same system just in a smaller facility in Waynesboro, Kentucky although he still remained very involved with the financial side of the facility during his five years there.

Lewis left Appalachian Healthcare for the former Baptist Health System of East Tennessee who had a contract with

LaFollette Medical Center in LaFollette, Tennessee. Lewis was brought in as the CEO of the facility, which had a nursing home attached to it but did not provide obstetric services. “It was my first step into what I call the real world as I managed both the balance sheet and the income statement. Adding to that the hospital was in the middle of a struggle between its Board of Directors and its owner, the city of LaFollette. The Board wanted to build a new general acute care hospital while the city council opposed it,” said Lewis. “We developed a strategic plan for the facility only to have the hospital sold after we revealed our plan. A two and a half year legal battle ensued over who had the right to sell the hospital and where the money would go. All while there was a Medicare fraud investigation from the previous administration going on. Ulti-mately, Tennova Healthcare System in Knoxville signed a long-term lease on the facility.”

After eight years in LaFollette, Lewis went to work for Catholic Health Part-ners at Lourdes Hospital in Paducah, Kentucky. “Initially I was brought in to help them turn the organization around financially, but it then became a perma-nent chief operating officer position,” said Lewis. “We turned the organization around in the first year. Over my seven years there we reinstituted the neurology program and started a pain management program.”

Lewis’ desire to once again be a CEO led him to the position at Hardin Medical Center (HMC). “I communicated with the Tennessee Hospital Association, who made me aware of the open position here,” said Lewis. “When I came to Savannah to visit, I really liked what I saw and not just in the hospital. The Board is all about doing what is right for the organization and there is not a lot of politics, it’s all about doing what is right. Plus the people are so nice. This may just be the friendliest place I have ever lived.”

Lewis brings to Hardin Medical Cen-ter what he describes as a participative management style, which he attributes to his mother. “My mother’s actions and di-rections led me to realize that just as play-ing sports, it’s a team-based environment. It’s not dependent on me, we are all in this together,” said Lewis. “I don’t have all the answers but have found the best way to reach the best answer is to involve all the key stakeholders. I think it is important to let people have the responsibility, the au-thority and the accountability needed to do what they are paid to do. Everyone has a role and when you get them in the right place it works really well. I look at things from the Golden Rule perspective treat people the way you want to be treated.”

Lewis sees as one of his strengths being a well-rounded individual in terms of finan-cial operations. “The depth of experience I have had allows me to bring perspective and insight that others may not have,” he said. “I say I am a ‘jack of all, master of none’ in that there are some things I do bet-ter than others.”

The transition into this new position and facility has gone smoothly. “Every change in leadership presents a new style and approach,” said Lewis. “And I know there are many things I do that are different from my predecessor and one style is not necessarily better than the other, just dif-ferent. Changing leadership presents many opportunities and we have all adapted pretty well to one another.”

As in his past positions, Lewis faces the challenge of positioning Hardin Medical Center for the healthcare changes that are coming. Being an independent rural facil-ity, Lewis says adds another layer to the challenge in that they are not cushioned as much as larger systems that have more economies of scale and more opportunities to disperse costs. “These reforms can really hit the financial side of things especially for Medicare dependent hospitals that live off reimbursements and those are declining,” he said. “Healthcare reform may negatively

impact many things.”“We still have a lot of independent

practices affiliated with the hospital which means we have to bring everyone together to the table to make accountable care work,” said Lewis. “That doesn’t always mean the hospital has to own everything but we do have to have relationships. There are models out there on how to make it work when we are given a set amount of money. We all want to come together and make this work.”

As in his other positions, Lewis sees being involved in state and national orga-nizations such as the Hospital Association and Healthcare Financial Management Association, as a way to stay abreast of what is coming down the pipeline. “These networking opportunities are a great tool that let you learn from others what they are doing to offset changes and how those prac-tices can be applied in your own facility,” said Lewis.

One goal on the horizon for Lewis is to get the players in the market to develop relationships that center around HMC. In the long run, he sees developing relation-ships with larger systems to assist in provid-ing provide other services needed in the community that are out of the spectrum of what the hospital currently offers. “Work-ing with a larger system can allow us to pro-vide what we need while making sure we are all benefiting,” said Lewis. “We will also be looking at our financial performance and different ways to make excess revenue over expenses.”

On the personal side of things, Lewis says that now that he and his wife have settled in to their new home on the river in Clifton, he intends to get back to focus-ing more on his health. An avid runner and cycler, Lewis usually finishes third or fourth in his age division and is anxious to get back to his competitive pace of training. As to what the future holds, Lewis said that is up to the Board. “This is by far the friendliest place I have ever lived,” he said. “And the thought of retiring here is not a bad idea.”

Healthcare Leader: Nick Lewis, continued from page 1

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John ArnoldTodd D. Siroky

CMS Proposes Broadening Medicare Enrollment Restrictions

To Combat FraudThe Centers for Medicare and Medicaid Services (CMS) in April pro-

posed several changes to the conditions for payment regulations governing Medicare enrollment (42 C.F.R. § 424.530) and the revocation of Medicare enrollment and billing privileges (42 C.F.R. § 424.535).

Together, these changes would empower CMS with even greater author-ity to deny or revoke Medicare enrollment privileges as a means of combat-ing fraud and abuse. As CMS evaluates comments and prepares to issue a final rule, Medicare providers and suppliers should be aware of three impor-tant changes CMS has proposed.

First, CMS proposes to expand its ability to deny enrollment for unpaid Medicare debt. Currently, CMS screens the enrolling provider, supplier, and the owner thereof for current overpayments. CMS, however, believes it is necessary to broaden the screening process to address situations where individuals and entities exit Medicare with sizeable debts and attempt to re-enter the program through new entities. Consequently, CMS proposes to extend screening to other entities the owner had a previous relationship with, and expand the inquiry from overpayments to Medicare debts generally.

In the final rule, providers and suppliers should pay close attention to how CMS addresses the meaning of a Medicare debt. Additionally, based on comments in the proposed rule, providers and suppliers should not be surprised if the final rule goes even further and allows CMS to deny enroll-ment based on the unpaid Medicare debt of managing employees.

The second important change would broaden CMS’ discretion to deny or revoke enrollment based on felony convictions. The current framework allows CMS to deny or revoke enrollment privileges if a provider, supplier or owner was convicted within the last 10 years of a serious felony (rape, mur-der, assault, etc.) or felony that poses an immediate risk to Medicare or its beneficiaries. The proposed rule would extend screening for felony convic-tions to all managing employees and adopt a more discretionary standard for determining what constitutes a disqualifying felony.

Specifically, rather than limiting screening to only certain felonies, CMS would have the discretion to deny or revoke enrollment privileges based on a conviction for any felony CMS deems detrimental to the best interests of Medicare or its beneficiaries. While this standard will almost certainly in-clude the felonies CMS currently screens for, providers and suppliers should evaluate the final rule for additional guidance on other types of felonies CMS considers detrimental to the Medicare program.

The third, and perhaps most troubling change, would allow CMS to re-voke the enrollment of providers and suppliers with a pattern or practice of billing for services that do not meet Medicare requirements. Of particu-lar importance, CMS specifically emphasized the requirements that claims must be reasonable and necessary, noting that a common situation in which revocation “could apply would be one where a provider or supplier is placed on prepayment review and a significant number of its claims are denied for failing to meet medical necessity requirements over time…”

Although CMS stressed it would revoke enrollment status only when an unusually high number of claims fail to meet Medicare requirements, provid-ers and suppliers should pay particular attention to how the final rule limits or clarifies the ill-defined “pattern or practice” standard.

Hot topics in HealtH law

by John Arnold


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unidentified powder, that might come to the attention of law enforcement officials. “This occurs more frequently than people realize,” Dreyzehner noted.

While biohazards are a small part of the overall lab workload, the state labs also play an integral role in analyzing environmental samples, conducting new-born screening panels, and identifying West Nile and other arboviral diseases. Equally important is the state’s work in preparing for threats that haven’t yet arrived.

“Right now we have spent a good bit of time and resources on MERS-CoV — Middle East respiratory syndrome coronavirus — and H7N9, a new strain of flu,” Dreyzehner said. “I hasten to add that neither of those have come to our shores.”

Being ready, however, has set Tennes-see apart. When H1N1 did strike America several years ago, the State Public Health Lab was on the forefront of running tests. At one point, Tennessee was doing testing for other states that didn’t yet have the ca-pacity to analyze incoming samples.

Since health threats come from many different arenas, it’s difficult to anticipate every scenario. “A key lesson is we never know where the next hazard is going to come from. We have spent a lot of time creating the infrastructure, relationships,

tools, and capacity to respond to any haz-ard,” explained Dreyzehner.

That was made abundantly clear in the recent issues with preservative-free meth-ylprednisolone acetate (MPA). He noted that in the fungal meningitis outbreak, the TDH relied heavily on the relationships and partnerships that were put in place well in advance of the crisis to effectively work with victims and to communicate informa-tion both internally and externally.

“We were able to use some existing capacities in some very innovative and novel ways to great success,” Dreyzehner said. One example, he noted, was using preparedness software developed for an-other purpose to track patients who had been exposed to the tainted MPA.

The team also relied on their capac-ity to collect and analyze data to predict the most effective treatment protocols and to identify those at risk. As Dreyzehner pointed out, going into this crisis there was virtually no literature on the particular type of fungus involved in the meningitis outbreak. “We were dealing with a situa-tion that no one had ever encountered be-fore.” Calling on relationships with federal agencies, national experts, and academic centers, Dreyzehner said the team quickly gathered and disseminated information to local provider resources across Tennes-see — including public health nurses and county public health staff — who have regularly reached out to inform and up-date those impacted by the tainted MPA.

Dreyzehner was quick to add this work is ongoing. “More than 13,500 peo-ple were affected by this … ranging from disconcerting to catastrophic,” he said. “This is still affecting more than 700 peo-ple around the country — 749 cases have currently been identified, and 63 people unfortunately lost their lives.

The need for a rapid and accurate information loop has spurred the state to enhance communication tools. “We need to be able to push our information to our healthcare partners and receive informa-tion from them in a more real time and co-operative space,” explained Dreyzehner. To that end, he said Tennessee is creat-ing the Health Joint Information Center, which is a concept derived from the Na-tional Incidence Management System.

“In order to provide the best informa-tion to the public and media partners, we create a place where partners and entities can pool information to make sure we are providing the right answers in a rapid fashion.”

Ultimately, it all comes down to building a scalable infrastructure, and a big part of that infrastructure comes from creating and maintaining relationships. “An emergency is the last place you want to be meeting people for the first time,” Dreyzehner pointed out wryly.

The smooth interaction between local providers, the TDH staff, and federal of-ficials during the meningitis outbreak un-derscored just how important it was to have previously developed relationships in place when it came time to act. “Just like community health providers and cen-ters are our eyes and ears, the state health departments are the eyes and ears for the CDC,” Dreyzehner said.

“We in public health rely on a variety of surveillance tools to detect concerns and to protect health,” he continued, adding the TDH relies on local healthcare person-nel, hospitals and health departments to draw attention to concerns. “We’re always thinking of the continuum of reporting,” Dreyzehner continued. The first call, he added, should be to the local health depart-ment to report the incident. “They are cer-tainly able to escalate that rapidly if there is a need,” he said, adding each department has a medical director and direct access to the state’s subject matter experts.

Dreyzehner said the best defense to protect against or respond to public health threats is working together.

“To the healthcare community, we ap-preciate you … we depend on you … and we will make every effort to keep you in-formed and work with you to protect life and health before, during and after an event.”

In Case of Emergency, continued from page 1

anti-HER2 drugs, Herceptin® and Kad-cyla®, both of which are antibody-type drugs attaching to the cell surface HER2 marker. Herceptin has been around a few years, but Kadcyla® is a new generation of drug, containing a strong cellular poi-son that is not released until it gets inside the cancer cell because of the HER2-neu receptor and then metabolically kills it, leaving the normal cells healthy.

With the above three special stains and standard tumor evaluation under the microscope, the pathologist can help guide Oncotype-DX® testing via a proliferative index marker. Of the four pathologic groupings of breast cancer, it is applied to so-called Luminal B tumors.

“It’s a surrogate for some of the info that’s on the Oncotype-DX® Breast,” Groshart said. “However, if it is a triple negative, it is particularly difficult to treat. Vanderbilt is currently studying triple negative breast cancers, and their prog-ress will change the way we do chemo-therapy.”

In all cancers, the research prolifer-ates nearly as quickly as the cells, giving pathologists and oncologists more infor-mation. Originally, the thought was only 5 percent of lung adenocarcinomas had targetable sites, but it is now known that actually around 15-20 percent do. Re-searchers have found a couple of targeta-ble sites within squamous lung cancer in the last year, and that information is being shared with drug companies that are try-ing to find targetable agents, he said.

Meanwhile, there is research on prostate tumors that won’t be ready for some time but is pivotal. Currently, pa-thologists can diagnose such tumors, but

some might not cause a problem and oth-ers might cost a man his life. Profiles are being developed to show predictability of metastatic disease across the range of prostate tumors.

Also promising are the upcoming in-novations in getting the immune system to recognize tumors. There are some prom-ising findings in melanoma. Mainly rec-ognized as a skin cancer, melanoma can derive from the gastrointestinal tract, the oral cavity and in epithelial tissue within membranes of the genital tract or in the pigmented epithelium of the eye. Within the 45 percent of melanomas unhelped by a targeted agent, there are a couple of drugs that turn on the immune system to the unique proteins on the tumor.

“Exciting stuff,” Groshart said.

Genetics, continued from page 4

Dr. Kenneth Groshart

Dr. John Dreyzehner


The CHS, HMA Chess Match Continues Acquisition Would Create the Nation’s Largest For-Profit Hospital Chain per Facility Number

By LyNNE JETER

FRANKLIN, Tenn. – Federal sub-poenas, contract disputes, lower admis-sions, rising bad debt, and a reduction in surgeries contributed to a move that in-dustry watchers now say was predictable.

On July 30, Community Health Sys-tems (Nasdaq: CYH), a Franklin, Tenn.-based hospital operator, announced plans to acquire Health Management Associates Inc. (NYSE: HMA), a Naples-based hospital group that, ironically, had been on a spending spree acquiring struggling hospitals.

In late March, For-tune magazine had named HMA among the World’s Most Admired companies in Health Care: Medical Facili-ties for the second consecutive year and fifth time in seven years. HMA has also been named the leading company for two subcategories in 2012: Use of Corporate Assets and Social Re-sponsibility.

Yet soon after HMA CEO Gary New-some announced retirement plans in May to preside over a Uruguay mission with the Church of Jesus Christ of Latter-day Saints, rumblings swept through Wall Street that the fiscally struggling public company might be the target of a takeover.

In a May 31 note to investors, Chris Rigg, an analyst with Susquehanna Fi-nancial Group, was cautiously optimistic that CHS might be pursuing HMA, esti-mating the company could be acquired for $18.50 a share, a premium to HMA’s shares that had recently traded near $14.

“We would be surprised if a transac-tion were announced in the very near-term,” he noted. “We don’t believe CEO Gary Newsome would be leaving the company in July if a formal auction process, which we expect HMA would conduct, were currently underway. That being said, we believe Community is the best-positioned name in the hospital group to operate HMA rural focused hos-pital assets.”

The EngagementIn a power play, the move became

official when CHS announced plans to acquire HMA for $3.9 billion in a deal valued at $7.6 billion, creating the na-tion’s largest for-profit hospital chains in terms of number of facilities.

“This is the second biggest hospi-tal deal announced this summer,” said healthcare industry consultant George Paul, antitrust partner with White & Case. In June, Dallas-based Tenet Healthcare Corp. (NYSE: THC) announced its ac-quisition of Nashville, Tenn.-based Van-guard Health Systems (NYSE: VHS) in a pact valued at $4.3 billion.

“This deal is part of a growing wave of hospital consolidation, as hospitals seek ways to diversify and lower costs in an-

ticipation of a sea change occurring in the healthcare industry with the imple-mentation of the Affordable Care Act, uncertainty over how states will handle Medicaid coverage and reimbursement, and Medicare changes,” he said.

Paul emphasized that under Obam-acare, scale will matter greatly as hos-pitals seek to cope with reimbursement changes and as consumers become in-creasingly price sensitive. “Insurers will pressure hospitals to become more effi-cient than ever, and as a result, it’s not surprising to see these two companies merge,” he added.

With a similar focus on non-urban locations, CHS leases, owns or operates 135 hospitals around the country. With HMA’s 71 hospitals, CHS would have 206 acute-care hospitals.

The antitrust review will focus on highly localized markets, Paul pointed out.

“While the two parties overlap in 29 states, it doesn’t appear that they have substantial overlaps on a localized level,” he explained. “The Federal Trade Com-mission (FTC) will focus on how many patients in an area would likely view the two operators as substitutes for each other in terms of location, quality and special-ties. Where the two are close substitutes, the FTC could seek divestitures if it were to find that patient choice may be lim-ited.”

The new CHS would be rivaled only by its across-town neighbor, Nashville, Tenn.-based Hospital Corporation of America (HCA), which has fewer hospi-tals (162), yet reports higher revenue. Last year, HCA raked in $33 billion; CHS and HMA had a combined $18.9 billion.

“This compelling transaction pro-vides a strategic opportunity to form a larger company with a diverse portfolio of hospitals that is well-positioned to real-ize the benefits of healthcare reform and to address the changing dynamics of our industry,” said CHS CEO Wayne Smith.

“Our complementary markets and the ability to form networks in key states, along with the synergies that will be available to us, can create value for the sharehold-

ers of our companies, the communities we serve,

our employees and medical staffs.”

Both com -panies’ boards of directors unani-mously approved

the definitive merger agree-ment. The deal

would give HMA shareholders a 16 percent stake in the new com-pany. Before the

market opened on July 30, the day of the announcement, HMA shares fell 6.9 percent to $13.89; CHS stock rose 2.4 percent to $48.35.

The UnravelingThe relationship between HMA and

its largest shareholder (14.6 percent), Glenview Capital Management, a hedge fund managed by billionaire Larry Rob-bins, had soured in recent months. Glen-

view, a private investment management firm established in 2000 with more than $6 billion of assets, also owns nearly 10 percent of CHS. Robbins had been criti-cal of HMA’s sluggish financial results and “unconstructive” executive behav-ior, pointing to HMA CFO Kelly Curry. Glenview had tried to replace HMA’s entire board of directors with eight can-didates in a Fresh Alternative campaign to revitalize the company. In June, Glen-view had written HMA about “significant room for improvement,” which it said had fallen short in its financial perfor-mance for more than a decade.

“Under the supervision of the sitting board, HMA lacks the financial acumen to deliver on its projections,” Glenview released in a July 30 statement. “Unfor-tunately, this continues to be the case.”

Another Nashville, Tenn.-based hos-pital group, LifePoint Hospitals (NAS-DAQ: LPNT), had also expressed interest in acquiring HMA.

Smith said he considered keeping CHS an independent company and ex-plored partnerships with other companies but decided acquiring HMA would “cre-ate value for the shareholders of our com-panies, the communities we serve, our employees and medical staffs.”



Shining a Light on Physician, Industry RelationshipsPhysician Payments Sunshine Act Now in Effect

By CINDy SANDERS

If you’ve recently enjoyed a golf outing with your friendly pharmaceutical rep or a nice dinner with a device manufacturer, that information will soon be available for all to see.

The Physician Payments Sunshine Act went into effect Aug. 1 of this year and requires applicable manufacturers to report certain interactions with physicians and teaching hospitals that are deemed to have value. ‘Applicable manufacturers’ are defi ned as pharmaceutical, device, biologic and medical supply manufacturers whose products either require a prescription to be dispensed or for which payment under fed-eral healthcare programs is available.

“The Sunshine Act generally applies when physicians or teaching hospitals re-ceive transfers of value from applicable manufacturers, and the applicable manu-facturers receive actual or potential value in return,” explained Tom Baker, a shareholder in the Baker Donelson Health Law group.

Baker, who practices in the fi rm’s Atlanta of-fi ce, pointed out the man-ufacturer doesn’t actually have to receive fi nancial benefi t in exchange for the ‘value transfer,’ which can take a wide variety of forms, including donated items, payment to a physician for consulting services or expen-ditures for entertainment. “It’s enough that it might infl uence a physician,” he noted.

“The Sunshine Act is about transpar-ency in two different fundamental ways,” he continued. “First, there is the potential interference in medical judgment in clini-cal trials required for FDA approval of drugs or medical devices. Second, there is potential interference in medical judgment in terms of ordering an item or service for which federal reimbursement is available.”

Baker said the policy is to shine a light on interactions that could be construed to unduly infl uence a physician or teaching hospital and to ferret out confl icts of inter-est. “It’s not saying that transfers of value are, per se, illegal but that the public has a right to know when medical judgment might be infl uenced by the value transfer,” he continued. Relationships between physi-cians and industry will now be on display for patients, auditors, personal injury law-yers and others to see when the Centers for Medicare and Medicaid Services (CMS) begins publishing the reported data next fall.

The Back StoryChampioned by Sen. Chuck Grassley

(R-Iowa) and Sen. Herb Kohl (D-Wis.), the impetus behind the Sunshine Act came from mounting concern over potential confl icts of interest within the industry.

These confl icts were highlighted by several egregious incidents involving clinical trials and devices up for FDA approval where physicians received large payments from the manufacturers of the drugs or devices being studied.

Grassley publicly described a num-ber of academic physicians taking money from the National Institutes of Health when those physician-scientists had direct fi nan-cial interests in their own research. Among the worst offenders, the former chairman of the Psychiatry Department at Stanford University received an NIH grant to study a drug when he owned $6 million in stock in the company seeking FDA approval. Similarly, the former chair of the Psychiatry Department at Emory failed to report hun-dreds of thousands of dollars from GlaxoS-mithKline while researching the company’s drugs. Harvard also had to discipline three researchers who received almost $1 million each in outside income while heading up several NIH grants.

Outside of these fl agrant examples, the concern persists that much smaller gifts might also infl uence medical decisions. Earlier this year, Pew Charitable Trust published Persuading the Prescribers: Phar-maceutical Industry Marketing and its In-fl uence on Physicians and Patients, which

stated the drug industry spent nearly $29 billion marketing their products in 2011 (Source: Cegedim Strategic Data). Of that amount, $25 billion was spent directly mar-keting to physicians.

After unsuccessfully introducing the legislation in 2007, the Sunshine Act was incorporated into the Affordable Care Act. A couple of missed rulemaking deadlines by CMS pushed the law’s effective date to Aug. 1, 2013 for the balance of this cal-endar year and requires annual reporting going forward.

What is a Transfer of Value?With 12 major exceptions (see box),

any direct payment or transfer of value of $10 or more (or an aggregate of $100 or more in a calendar year) to a physician or teaching hospital must be reported. Addi-tionally, indirect transfers through an inter-mediary or third party are also subject to reporting.

There are 14 main reporting cat-egories. These include consulting fees, compensation for services other than con-sulting, gifts, entertainment, food, travel, charitable contributions, education, grants, research, royalty or licensing fees, current or prospective ownership or investment interest, direct compensation for serving as

faculty or a speaker for a medical education program, honoraria.

Under the new rules, Baker said a phy-sician could accept a ballpoint pen or pad of sticky notes from a manufacturer without it being included in the annual report, but most meals, tickets, or gifts probably will fall under one of the reporting categories con-sidering the $10 threshold.

“The days of the pharmaceutical com-pany taking a group of physicians to the Super Bowl are over … or at least it will be disclosed and expose you to the risk of Anti-Kickback statute prosecution,” Baker said. “It’s the entertainment part of it that physi-cians would probably like to have exposed the least,” he added.

The law also requires applicable man-ufacturers and GPOs (group purchasing organizations) to report ownership inter-ests by physicians or their immediate fam-ily members. It should be noted, however, that purchased industry stocks and mutual funds that are generally available to the public are not reportable. If Dr. Smith buys 50 shares of ABC Pharmaceutical stock, which is publicly traded, it doesn’t have to be reported. If a representative of ABC Pharmaceutical gives Dr. Smith stock, then it does.

Ultimately, a patient whose doctor rec-ommends a specifi c device or drug will be able to search the CMS database to see if there is a connection between the physician and the manufacturer. “You’re going to know when your physician has a personal fi nancial interest in your healthcare beyond the physician’s professional services,” Baker pointed out.

Disputing a ReportSo what happens if your name ap-

pears on a report, and you disagree with the data? Baker said CMS is going to notify physicians of all their reported relation-ships. Once access is granted to the online portal housing the consolidated report, a physician should have at least 45 days to challenge the data and try to resolve the dispute with the reporting entity.

Those who cannot agree will be given an additional 15 days to come to a resolu-tion before the information is made public. If no agreement can be reached, the data will be published but fl agged as disputed. Physicians cumulatively have up to two years to dispute reports even after the data is published.

“While physicians aren’t required to track transfers of value, they are encour-aged to do so,” said Baker. “How in the world are you going to be able to refute a report if you don’t have evidence to the contrary.”

Baker pointed out you might not think you received an infl uential ‘gift’ from a de-vice manufacturer by grabbing a bite of lunch, but even a sandwich, tea, tip and

12 Key Exemptions to the Reporting Rule

Certifi ed and accredited CME.

Buffet meals, snacks, coffee breaks that are provided by a manufacturer at a large-scale conference or event when the items are generally available to all attendees.

Product samples that are not intended for sale and are for patient use.

Educational materials that directly benefi t patients or are intended for patient use.

The loan of a medical device for evaluation during a short-term trial period (not to exceed 90 days).

Items or services provided under a contractual warranty in the purchase or lease agreement for a device.

The transfer of any item of value to a physician when that physician is a patient and not acting in his or her professional capacity.

Discounts including rebates.

In kind items for use in providing charity care.

A dividend or other profi t distribution from, or ownership or investment in, a publicly traded stock or mutual fund.

Transfer of value to a physician if the transfer is payment solely for the services of the physician with respect to a civil or criminal action or an administrative proceeding.

A transfer of anything with a value of less than $10 unless the aggregate amount transferred to, requested by, or designated on behalf of the physician exceeds $100 in the calendar year.

Tom Baker



For more information contact Brian Bradberry at [email protected]. Or Call 731 642 2011

Healthcare is Changing.ADMINISTRATORS

How can you stay on top of the issues? Join West TN

MGMA in 2013!

Join Us At Our Next

LuncheonTommy Pruitt with Horne CPAs will speak on their Healthcare

Delivery Institute Program

September 25th11:30 am

Flatiron Grille

WEST TN MGMA

The Next StepUntil the merger is completed –

the target deadline is March 31 – John Starcher Jr., president of HMA’s Eastern Group with 23 hospitals in seven states, will step up as HMA interim CEO.

HMA’s projected second-quarter earnings show a drop of .05 percent in net revenue to $1.46 billion, attributing the discouraging fiscal picture to low ad-missions, increases in observation stays, higher bad debt, a reduction in surgeries, and the federal government’s sequestra-tion. Same-hospital admissions were pre-dicted to fall 6.7 percent, compared to the second quarter of 2012.

In its first-quarter financial filing, HMA reported it had received a sub-poena from the U.S. Securities and Ex-change Commission (SEC) for documents involving accounts receivable, billing write-downs, contractual adjustments, re-serves for doubtful accounts, and revenue. In May and June, HMA received three more subpoenas from the HHS’s Office of Inspector General related to the pro-cess by which the company admits people from its emergency department. The new subpoenas supplemented ones the company received in 2011. Another sub-poena was issued on physician relation-ships. In December, a CBS “60 Minutes” segment focused on HMA’s aggressive policies aimed at increasing admissions and “disgruntled former employees.” No stranger to the federal pressure-cooker, CHS recently received a new subpoena for similar allegations from the Depart-ment of Justice.

The CHS, HMA Chess Match, continued from page 11

diagnosis, and another which studies cost-savings of Child Life programs.

It’s a drop in the bucket of what may come later. Grissom said there is almost no research being conducted in the area of Child Life, even though the children who survive exhibit remarkable qualities like an adult-like maturity.

“It’s like a bunch of little adults run-ning around,” said Grissom. “Children’s hospitals tend to be joyful places because children are resilient and they move through things unlike adults do. They see who they want to become. They see what they have to do. They learn things that most children don’t learn.”

Part of their maturation often is ex-pressing the desire to give back and help others.

“By watching the staff and seeing what’s been given to them, (patients) see the relief that mom and dad have from being here at St. Jude, and they want to give back as much as they can,” said Gris-som. “It’s pretty amazing. Children want to sell cookies or crafts so they can give us their quarters.”

Child Life Specialists, continued from page 6

More Information for Physicians

The American Medical Association has put together the “Physician Sunshine Act Tool Kit” with additional information on the new requirements, a webinar and links to the free mobile app. To access the kit, go online to www.ama-assn.org/go/sunshine.

tax is often over the $10 threshold. Short of asking to see the bill, it would be difficult to gauge the cost per person at the table; and without a copy of the receipt, it would be difficult to dispute the reported item.

“As a practical rule, doctors probably aren’t going to be good at refuting the evi-dence,” Baker said.

However, he added, CMS has created a smartphone app with a version for indus-try and another for physicians to make it easier to keep track of reportable transfers. “Open Payments Mobile” is available at no charge through the Apple Store and Google Play Store.

TimelineData accumulation for 2013 has al-

ready begun. Below is a timeline of upcom-ing key dates in the process. • Jan. 1, 2014: Anticipated launch date for CMS physician portal where doctors can register to receive notice when their individual consolidated report is ready for review. This portal also provides a means for physicians to contact manufacturers and GPOs about disputes in accuracy. • March 31, 2014: Partial year data (August-December 2013) must be turned into CMS. • June 2014: Anticipated access to in-dividual consolidated reports from 2013. Physicians have a minimum of 45 days by law to seek corrections or modifications to the information by contacting manufactur-ers/GPOs through the portal.September 2014: Searchable reports are published and open to the public.

Be Prepared“The act itself is vexing,” said Baker.

Adding to the frustrations, he continued, is that CMS is interpreting the Sunshine Act very broadly.

“The applicable manufacturers are not going to take any chances,” Baker contin-ued. He noted, those who accidentally fail to disclose required data will face penalties of not less than $1,000 and not greater than $10,000 per incident up to a cap of $150,000 annually. Those who knowingly withhold reportable information face penalties be-tween $10,000 and $100,000 for each value transfer with an annual cap of $1 million.

“Physicians need to know other people are going to be talking about them,” con-cluded Baker. “One would hope everything reported is within the legal boundaries … but if you are testing those boundaries, you better stop.”

Shining a Light,continued from page 12

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The 2nd Annual Zombie Run is back!

On October 12th at 8:00 AM, Run-ners can come and run with the Zombies. It is an awesome time for businesses to advertise their services! For $100.00 spon-sorship, they will get their name on the t-shirts (approximately 200) and have a personal zombie for the race. The zombie will sport their logo throughout the route and greet runners and spectators. The proceeds for the race will go to the chil-dren of St. Jude and Back Pack Program. Please make checks out to the Zombie Run! Thanks for your support!! For more information, call Kris Moore, MS, at 731 588 2830.

The Jackson Clinic Announces Addition of New Pediatrician

The Jackson Clinic re-cently added Dr. Michelle Puzdrakiewicz to their Pe-diatric Department. Dr. Puzdrakiewicz joins Dr. Lisa Anderson, Dr. E. Carlton Hays, Dr. Scott Owens, Dr. James Payne, Dr. Tara Pedigo, Dr. Hannah Shelby-Kennedy, Dr. William Stepp, Jr. and Dr. William Woods, Jr.

Dr. Puzdrakiewicz received her Doc-tor of Medicine degree from Tulane Uni-versity School of Medicine, New Orleans, Louisiana. She also received her Master’s degree in Public Health Administration from Tulane University School of Public Health, New Orleans, Louisiana. Dr. Puz-drakiewicz completed her residency and internship at University of California, Davis Medical Center, Sacramento, California. She is Board Certified, American Board of Pediatrics.

The Jackson Clinic Pediatricians are committed to serving the infants, children and adolescents of West Tennessee. It is their goal to provide superior care that meets a child’s unique healthcare needs.

West Tennessee Healthcare Offers Free Neighborhood Health Fairs

West Tennessee Healthcare is bring-ing its annual free health fair out into the Jackson communities!

West Tennessee Healthcare decided to move the annual health fair tradition-ally held at the Carl Perkins Civic Center to different areas of the city to encour-age residents to take advantage of the free services. You are invited to four “Neighborhood Health Fairs” with free adult screenings and free exhibits at the following dates and convenient locations around Jackson:

Saturday, October 5: 8 a.m.-11 a.m. Malesus Baptist Church; 480 Old Malesus Road

Saturday, October 19: 8 a.m.-11 a.m. Liberty Park; 24 Channing Way

All of the locations will offer the same services including adult screenings for bone density, blood pressure, grip strength, vision, body mass, balance and online “awares” testing.

West TN Medical News is published monthly by Medical News, Inc., a wholly-owned subsidiary of SouthComm, Inc. ©2013 Medical News Communications. All rights reserved. Reproduction in whole or in part without written permission is prohibited. Medical News will assume no responsibilities for unsolicited materials. All letters sent to Medical News will be considered Medical News property and therefore unconditionally assigned to Medical News for publication and copyright purposes.

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GrandRounds

Dr. Michelle Puzdrakiewicz


I don’t just have insurance.

I own the company.

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Contact David Willman or Susan Decareaux at [email protected] or 1-800-342-2239.

SVMIC is endorsed exclusively by the Tennessee Medical Association and its component societies.

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The Jackson Clinic Shows Improved Quality, Lower Costs in Cigna’s Collaborative Accountable Care Program

First-year results from Cigna’s (NYSE: CI) collaborative accountable care initia-tive with The Jackson Clinic indicate that the program is showing progress toward achieving the “triple aim” of improved health, affordability and patient experi-ence. The Jackson Clinic serves over 5,500 individuals covered by a Cigna health plan and has shown significantly positive results in delivering quality care while controlling total medical cost trend.

Cigna quality of care measures com-pare how well a physician practice follows guidelines for evidence-based medicine relative to other practices in the same geographic area (market) across the pa-tients with Cigna coverage. During calen-dar year 2012, the Jackson Clinic outper-formed its peers on a number of impor-tant measures:

• 19% better than market for annual eye exams for people with diabetes

• 25% better than market for annual screenings for kidney disease for people with diabetes

• 7% better than market for breast cancer screenings

• 50% better than market for adoles-cent well-care visits

Cigna also measures cost-efficiency by comparing a physician practice’s to-tal medical cost trend relative to other practices in the same geographic area (market). During calendar year 2012, The Jackson Clinic experienced an overall to-tal medical cost trend of nearly five per-cent lower than the local market.

A number of factors contributed to these results, including high referral rates to Cigna Care Designated special-ists (physicians in certain specialties who meet/exceed Cigna-specific quality and cost-efficiency criteria), a focus and dedi-cation to improving inpatient hospital costs, and helping frequent emergency room users receive the care they need in the most appropriate setting. During 2012, The Jackson Clinic had:

• 10.5% better inpatient hospital cost trend compared to market

• Half as many frequent emergency users compared to market, resulting from additional Convenient Care locations and extended office hours

• 70% better referral rate to Cigna Care Designated specialists compared to market

To make the program work a regis-tered nurse, employed by The Jackson Clinic, serves as a clinical care coordina-tor and helps patients with chronic condi-tions or other health challenges navigate the health care system. The care coordi-nator is aligned with a team of Cigna case managers to ensure a high degree of col-laboration between the medical group and Cigna that ultimately results in a bet-ter experience for the individual.

Other factors that also contributed to The Jackson Clinic’s positive results in-clude:

Participation in a “Transition of Care” pilot, in which The Jackson Clin-ic’s embedded clinical care coordinator reaches out to patients following hospital discharge to schedule them for a visit with their primary care doctor within seven days;

Increased office hours and additional locations to give patients an alternative to the emergency room when seeking care;

Educational postcards available at Jackson Clinic locations explaining when it may be appropriate to use urgent care facilities or the emergency room and how

patients can contact Jackson Clinic to set up a same-day appointment;

The introduction of services at a skilled nursing facility, as an alternative patient care setting to avoid extended in-patient hospital stays when appropriate; and,

An effective hospitalist program focused on frequent emergency room users, with the clinical care coordinator reaching out to patients to provide guid-ance and education on the most appro-priate care settings.

The principles of the patient-cen-

tered medical home are the foundation of Cigna’s collaborative accountable care initiatives. Cigna then builds on that foun-dation with a strong focus on collabora-tion and communication with physician practices. Cigna has 66 collaborative ac-countable care initiatives in 26 states, en-compassing more than 700,000 commer-cial customers and more than 27,000 doc-tors, including more than 12,500 primary care physicians and nearly 14,500 special-ists. Cigna launched its first collaborative accountable care program in 2008 and its goal is to have 100 of them in place.

GrandRounds

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