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Brantley Performs Alabama’s First Eluvia Stent Procedure By laura FreeMan

Stretching Himself The story begins with a young electrical engineering grad fresh out of Ohio University with a double major in chemistry. It was the late 90s, and he was on the road to a PhD in biomedical engineering with no clear aim ... 3

The same processes that cause dangerous narrowing of the blood vessels that supply the heart can also cause damage in other parts of the body. When the femoral artery and other vessels supplying the lower body are involved, the situation can become so severe that relentless pain, difficulty walking, non-healing wounds, and ultimately the possibility of amputation can loom over a patient. In response to this problem, the industry developed stents designed to improve blood flow in peripheral vascular disease. “The problem with earlier stents was that restenosis tended to occur too quickly” Hutton Brantley, DO of Cardiology PC said. “The proce(CONTINUED ON PAGE 8)

Cardiovascular Associates Tops National Enrollment in Trial for PAD Relief Birmingham’s Cardiovascular Associates has become the highest enrolling site in North America for the Surmodics TRANSCEND drug-coated balloon (DCB) trial ... 5

Hutton Brantley, DO (4th from left) and the Princeton team following the first Eluvia Stent procedure in Alabama.

New Products Help Hemophilia Patients By ann deBelliS

Hemophilia is a rare, inherited bleeding disorder in which the blood does not clot normally. According to the U.S. Centers for Disease Control & Prevention, these patients bleed for a longer time than other people following an injury. The also can bleed internally. Oncologist Brian Adler, MD, treats hemophilia patients at his Brookwood Baptist clinic. “Hemophilia A is the most common and affects blood clotting factor 8. It occurs in one to 5,000 males,” he says. “Hemophilia B is less common and occurs in

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Brian Adler, MD

one to 25,000 males. It results from an affected factor 9.” Adler points out that while he treats the disorder, most of the hemophilia patients in Birmingham and the State of Alabama are treated at the Hemophilia Treatment Center through Children’s Rehabilitation Services. Christina Bemrich-Stolz, MD, MSPH, is the pediatric oncologist at the Birmingham treatment center and is also an assistant professor in the UAB Division of Pediatric Hematology and Oncology. She says that while many of these patients are diagnosed (CONTINUED ON PAGE 10)

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Birmingham Medical News


HEALTHCARE SPOTLIGHT

Stretching Himself By Jane Ehrhardt

The story begins with a young electrical engineering grad fresh out of Ohio University with a double major in chemistry. It was the late 90s, and he was on the road to a PhD in biomedical engineering with no clear aim. “Then I was paired with a guy who studied the heart and, week one, I saw open-chest heart surgery,” says David Fieno, MD, PhD. “Everything I studied became applicable— there was this electrical thing that was also a mechanical thing; the beautiful simplicity of it, the timing of the beat. I fell in love with the heart that day.” Fieno then spent his next four years of grad school asFieno and his sons enjoy fishing in the Gulf of Mexico. signed to a mechanical engineering project that worked Medical Center, which recently acquired western. Three years later, in toward devising an MRI for Fieno danced in his first competition. a cardiac MRI at the end of last year. 2003, he headed to California the heart. “Whereas other Fieno admits his move to the south and completed his residency in students on the project were after seven years on the California coast internal medicine at Cedars-Sinai Hospiinto the computer doing equations, I was Fieno knew engineering wasn’t for him. “I was spurred by a call to be needed. “LA tal and stayed another three years for a felthe guy who had the hands-on part seecould do the work, but I didn’t love it,” he is beautiful and absurdly expensive, and lowship in cardiology and cardiovascular ing patients inside the hospital. And that says. “My last two years on the project, I there are way too many cardiologists diseases. led to me being able to contribute to that got to work with clinical trials and realized there,” he says. “At Cedar Sinai alone, Then in 2010, he decided to make a field,” he says. that was my true calling. I fell in love with 260 cardiologists had privileges. There are major switch, and moved to Birmingham At the time, the MRI produced dypatient care.” not 260 cardiologists in the state of Alato join Heart South Cardiovascular, namic, crisp images of the heart. “It was So after attaining his engineering a group affiliated with Shelby Baptist beautiful but not good for anything,” PhD, he entered medical school at North(CONTINUED ON PAGE 8) Fieno says. “It only confirmed what we already knew from ultrasound, but in prettier pictures.” And it cost about $5,000 per test. So Fieno’s team began focusing on the aspect of the MRI that, unlike any other imaging tech, allows it to provide entirely new data based on how the machine acquires the image. “How you adjust parameters can make the image look entirely different,” he says. Gadolinium proved to be the breakthrough. “We took the same images of the moving heart, but we administered a contrast agent,” Fieno says, adding that gadolinium-based contrast agents are given thousands of times a day to MRI patients everywhere. “It turned out that it accumulated in the dead area of the heart and made them brighter on the images.” They went on to develop a way to image those bright and non-bright areas. “It was the first time in cardiac history that you could see the exact size of Now providing CPAP, Bio-identical hormone replacement therapy for women the dead muscle and relate it back to the and men (progesterone, estrogen & testosterone) BiPAP, portable oxygen moving heart,” he says. “There is no other Free initial hormone replacement consultation for new patients concentrators, & supplies. tech that could do that.” The gadolinium-enhanced imaging is Pharmacy staff with over Erectile Dysfunction medication options starting at $20 now considered to be the gold standard 100 years combined experience for myocardial viability to determine Discreet pickup location or home delivery options which parts of the heart are alive or dead. accuRXpharmacy.com “Other techs provide clues but they canIn-office Infusion Center for biologics and other infusions not tell you what’s viable and not viable,” Nebulized medication program with a Nurse & Respiratory Therapist Fieno says. But even with this accomplishment,

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CARDIOVASCULAR

Grandview Electrophysiology Lab By Jane Ehrhardt

When Grandview Medical Center opened its doors in 2015, their new electrophysiology program began with one lab. “We had a vision to build up the lab and create growth based on quality components,” says Jose Osorio, MD, a cardiac electrophysiologist (EP) and the medical director of the Electrophysiologist Lab at Grandview. “We have a lot of quality improvement meetings.” To stay on target, the EP team focused EP Lab physicians (l to r): Drs. Gustavo Morales; Anil Rajendra; Russell Reeves; Jose Osorio; Macy Smith and Joaquin Arciniegas. on measuring outcomes and analyzing Five months after that one, they opened a 120 to 150 left atrial appendage (LAA) data. They also participated in a myriad third. Now, after only three years, Grandclosures,” Osorio says. Device implantaof research to stay up on the latest breakview’s EP program keeps four labs bustions totaled about 2,500, including defithroughs and devices. “This allowed us to tling daily. brillator implants, pacemaker implants, be successful and referrals continued to “We do about 1,500 ablations a and loop recorder implants. The lab volgrow,” Osorio says. That generated the year—900 are for atrial fibrillation ablaume increased over 19 percent in 2018 need for more labs, and the hospital retions and over 200 ablations are for vencompared to 2017. sponded. A few months after the first lab tricular arrhythmias. And we do about Grandview’s EP Lab also became opened, they had a second lab running.

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only one of four in the country—and the first in the Southeast—to attain Cardiac Electrophysiology Accreditation under the Intersocietal Accreditation Commission. A targeted triumph of the ablation aspect of the EP program has been to reduce the use of fluoroscopy—a radioactive component—in their atrial fibrillation procedures. “We have performed almost 4,000 ablations without fluoroscopy,” Osorio says. “Hundreds of electrophysiologists and staff members from all over the country have visited our institution to learn these techniques.” The left atrial appendage (LAA) closure that Osorio performs reduces the risk of stroke from blood clots caused by the inefficient beating of an AFib heart. It is most commonly performed on patients unable to take the traditional treatment of

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CARDIOVASCULAR

Cardiovascular Associates Tops National Enrollment in Trial for PAD Relief By Marti Webb Slay

Birmingham’s Cardiovascular Associates has become the highest enrolling site in North America for the Surmodics TRANSCEND drug-coated balloon (DCB) trial. The randomized trial seeks to find an improved treatment for peripheral artery disease (PAD), a build-up of deposits that cause narrowing or blockages of blood vessels in the legs. “Historically, when we repair femoral arteries, the biggest challenge has been that, over time, they shut down and the patient is back with the same problem a few months after the procedure,” said Jan Skowronski, MD, MBA, FSCAI, director of Endovascular Therapies at Brookwood Baptist Medical (l to r) Drs. Jan Skowronski and Gary Roubin Center. “This has been frustaining medication to prevent restenosis trating to the patients as well as to the medientered the market. These drug-coated balcal community. loons have helped tremendously. St Jude “Over the last five years, balloons con-

and Medtronic were the first to the market with them. CVA was invited to be one of the sites for a randomized clinical study with an iteration of the device, potentially allowing a better penetration of the medication into the arterial wall.” “Drug-eluding balloons have helped tremendously to prevent the re-blockage of femoral arteries,” Gary Roubin, MD, FACC said. “This study has looked at a variety of balloons that we believe will be superior to what we’ve been using over the past few years. This new technology allows more of the medication that prevents restenosis. The medication is attached to the balloon, and Surmodics has perfected a way to deliver more of the drug in a more uniform way up and down the entire length of the treated segment. We’re excited to be able to offer this to our patients within the confines of the study.” CVA is one of 78 study locations enrolling a total of 450 patients. With 55 to

60 percent already enrolled, Skowronski anticipates the trial will end enrollment this spring and the study will be un-blinded a year later. “We think we will cut the restenosis rate by two-thirds compared to regular balloons,” he said. The minimally invasive procedure requires only mild sedation. The blocked artery is first opened with a regular balloon. Then a balloon with the drug paclitaxel is inflated to treat the lesion. The procedure is typically outpatient with most patients returning home that day. “It is extremely safe,” Roubin said. “We can relieve incredible discomfort and improve the quality of life dramatically. The ability to treat these blockages is one of the great triumphs of endovascular therapy. The only down side was that the blockages tended to come back. And now we can prevent that.” Patients who meet the requirements of the trial include those with leg pain from blocked arteries. “We also enroll patients with small wounds because of bad circulation,” Skowronski said. “We welcome referrals for consideration to participate in the study. And although some patients may not fit guidelines for inclusion, they (CONTINUED ON PAGE 9)

A COMMUNITY BUILT ON HEART At Brookwood Baptist Health, we never forget that there’s more to care than medicine. There’s compassion. Attentiveness. And a healthy dose of kindness. Which is why when it comes to treating your heart, all of us are here to treat you well. See us at BrookwoodBaptistHealth.com/heart

You can’t help a heart unless yours is in it. Birmingham Medical News

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CARDIOVASCULAR

New Generation Ultrasound May Improve Stenting Procedures By ann B. deBelliS

UAB cardiologists are the first in the United States to perform a post-market study of a new high-definition intravascular ultrasound (HD-IVUS) used for stenting cardiac arteries. IVUS has been an option for cardiologists for almost 30 years, but many physicians still routinely use angiography for placing heart stents. The new 60 MHz HD-IVUS provides higher image resolution than the conventional 40 MHz model, and UAB researchers believe it will improve outcomes for heart patients. “This next-generation IVUS gives

us the ability to assess the entire vessel wall structure, which allows us to better assess the patient’s situation and to make good decisions for their care that will give us optimal results,” says UAB Massoud Leesar, MD Cardiologist Massoud Leesar, MD. When making the decision to put a drug eluting stent in a vessel wall, a physician must measure the size of the stent needed for the procedure. “If you can see a clear image of the vessel wall, you can

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be more accurate in the placement of the stent. Precise implantation of coronary stents is important to prevent adverse outcomes. Under-expansion and strut malposition of a coronary stent is associated with higher incidence of restenosis and stent thrombosis,” Leesar says. “Recent randomized trials of IVUS with drug eluting stents showed that IVUS-guided stenting significantly reduced the incidence of stent restenosis.” The HD-IVUS has transducers that are miniaturized to less than four-hundredths of an inch and placed on the tip of a catheter. The catheter can be slipped into the coronary arteries over the same

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guide wire that is used to position angioplasty balloons or stents. It becomes, in effect, a tiny camera that gives a crosssectional view of the artery. The other end of the catheter connects to a computer workstation that converts the sound waves from the transducer into real-time images on a monitor. IVUS uses high-frequency sound waves to provide images from inside the blood vessels. Sound waves sent from the transducer bounce off of the walls of the artery and return to the transducer as echoes. A computer converts these echoes into images on the monitor to produce pictures of the coronary arteries or other blood vessels. The HD-IVUS provides a higher image acquisition rate and enables highspeed pullback imaging at up to 10 millimeters per second, compared to the 0.5 millimeter-per-second 40 MHz IVUS. “This new model also has the technical advantage of improved detection of lumen and vessel borders due to higher blood speckling and lower signal penetration depth within the tissue, and it can distinctly differentiate three levels of the vessel wall – the intima, media and adventitia,” Leesar says. “This will allow better assessment of the vessel pathology and assessment of the stent expansion.” UAB researchers are the first to develop a protocol for using the HD-IVUS to determine which technique is best. They already know that HD-IVUS provides better image quality and can better determine the size of the stent, but they want to make sure they are using the right technique in these patients. “We have used a special technique in some patients who receive drug eluting stents, but it is not finalized,” Lessar says. “Generally, each physician chooses a technique based on intuition. That’s why we are studying each technique used at UAB for placing stents. It is simple and can be done, but it has not been systematically studied.” Currently approximately 55 percent of patients are archiving an optimal stent expansion by using IVUS. On the other hand, using the new technique of stent expansion by HD-IVUS, the percentage of optimal stent expansion can be achieved in 80 to 90 percent of patients. Leesar says this study is the first step to explore this technology and to attain approval to use it. “I’m sure other hospitals have this technology, but our aim is to take advantage of it and to use the special technique to attain optimal results,” he says. “We will be able to expand this technology to improve outcomes of stenting, which is our primary goal.


CARDIOVASCULAR

Updated Cholesterol Guidelines Take a Personalized Approach By CINDY SANDERS

The American Heart Association (AHA) and American College of Cardiology (ACC) recently released an update to the 2013 cholesterol guidelines, calling for more personalized risk assessments to guide primary and secondary cardiovascular disease prevention throughout a patient’s lifetime. “Both guidelines were very much based on the evidence that has developed in terms of what can benefit patients,” said Neil Stone, MD, MACP, FAHA, FACC, who worked on the 2018 guideline update and served as vice chair of the writing committee. Stone, a Chicago-based carNeil Stone, MD, diologist and AHA MACP, FAHA, FACC national spokesperson added, “Both begin with emphasizing that lifestyle change is most important.” In fact, he continued, the new guidelines focus on adopting a heart-healthy lifestyle from a young age and build upon the 2013 emphasis on identifying and ad-

dressing lifetime risks to prevent cardiovascular disease (CVD). The update also provides additional guidance for physicians to help them drill down for a more robust and personalized risk assessment that considers multiple factors and treatment paths. The need for personalized risk stratification and intervention is great in the United States. Stone pointed out we live in a country where one of every three people dies of heart disease or stroke annually

and nearly six in 10 people develop heart disease during their lifetime. Additionally, he said, one-third of American adults have high levels of low-density lipoprotein cholesterol (LDL-C), known as the ‘bad’ cholesterol that contributes to plaque buildup and narrowed arteries. Key highlights from the updated cholesterol clinical practice guidelines statement, which was released this past November during the AHA’s 2018 Scientific Sessions conference in Chicago, include: High cholesterol, at any age, can increase a person’s lifetime risk for heart disease and stroke. A healthy lifestyle is the first step in prevention and treatment to lower that risk. The 2018 guidelines recommend more detailed risk assessments, called risk enhancing factors, to help healthcare providers better determine a person’s individualized risk and treatment options. In some cases, a coronary artery calcium score can help determine a person’s need for cholesterol-lowering treatment, if their risk status is uncertain or if the treatment decision isn’t clear. While statins are still the first choice of medication for lowering cholesterol, new

drug options are available for people who have already had a heart attack or stroke and are at highest risk of having another. For those people, medication should be prescribed in a stepped approach, first with a maximum intensity statin treatment, adding ezetimibe if desired LDL cholesterol levels aren’t met and then adding a PCSK9 inhibitor if further cholesterol reduction is needed. Stone, who is a professor of medicine at Northwestern University’s Feinberg School of Medicine and the medical director of the Vascular Center of the Bluhm Cardiovascular Institute of Northwestern Memorial Hospital, noted that for those trying to prevent a first heart attack or stroke, personalized risk stratification informs next steps for primary prevention. For those trying to prevent another heart attack or stroke, the guidelines provide additional treatment options for those at very high risk.

Primary Prevention For those who have not yet had a heart attack or stroke, Stone said the updated guidelines call for patients with a very high LDL – 190 or more – to be

Birmingham Medical News

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FEBRUARY 2019 • 7


Brantley Performs Alabama’s First Eluvia Stent Procedure, continued from page 1 dure often had to be repeated within only a year or so. “The next generations of stents were coated with a slow release medication aimed at limiting the proliferation of cells that can cause restenosis. This strategy was promising, but we still didn’t see the kind of results we were hoping to achieve. Since I work with a lot of PVD patients, I was keeping a close watch on the success the Eluvia stent was having in the IMPERIAL trial. It was the first head to head comparison, and the results were remarkable.” Clinical trial results showed a primary patency rate at 12 months of 88.5 percent compared to 79.5 percent with the other option. The revascularization rate of the target lesion was half as high, and 95.1 percent of the Eluvia patients were free of major adverse events compared with 91 percent with the other system. “I contacted Boston Scientific to learn more, and the rep helped us prepare so we’d be ready to offer the Eluvia stent to our patients as soon as FDA approval came through,” Brantley said. In early October of last year, Brantley used the Eluvia stent in a procedure for the first time in Alabama. Since then, it has been the stent of choice for 16 of his patients. “After we place the stent in the artery, it continues to deliver paclitaxel for an extended period,” he said. “So far, we are very pleased with the results. If we continue to see the kind of performance the

Eluvia stent showed in trials, it is going to make a major difference for many of our patients.” Made with polymers on a purposedesigned platform to fit the twists and turns of the leg’s vascular system, the Eluvia stent is available in multiple lengths and diameters. When the stenosis isn’t too severe, the condition may be asymptomatic and can be managed with medication, walking and lifestyle changes. But when the narrowing becomes symptomatic and the muscle is starved of blood, the patient can be in a great deal of pain with their quality of life diminished.

Patients might assume the pain is arthritis and that nothing can be done beyond their arthritis medication, which can leave them suffering needlessly as the condition progresses. If they have symptoms or the same factors that put them at risk for heart disease—cholesterol and lipid problems, smoking, age, inactivity or metabolic problems like diabetes—they should be screened for peripheral vascular disease. “In the office, you can check for abnormal pulses in their legs or use ultrasound or other imaging,” Brantley said. “Finding the condition early and beginning treatment could help to slow down

the progression.” After the procedure, Brantley encourages his patients to follow up with lifestyle changes to help keep their stent clear and the blood flowing. “Stopping smoking, eating healthy and working to keep cholesterol down, while walking more can make a difference,” he said. “With the relief the stent gives them, patients find it easier to be more active. It improves their quality of life. I work with many different types of cardiology conditions, and I find that PVD patients seem to be the most excited about being able to once again do the things they enjoy without pain.”

Stretching Himself, continued from page 3 bama. So the move gave me a challenge of not knowing the landscape and how people interacted, but I was where people needed my help.” Fieno is a seeker of new experiences. He has recently branched out to appear on local news and talk shows to discuss heart health. He also learned to ski last year, and took up ballroom dancing. “I was in my first competition last weekend. I was terrified,” he says. “I performed 12 dances. I have two left feet, so this was a big digression from what was comfortable for me. But I placed second in my little category.”

He’s instilled that same sense of adventure in his young sons, who he has gotten hooked on deep-sea fishing. “Now they are obsessed with catching their first grouper and sailfish,” he says. And his endless stretching of his own limits has led him to pick up the traditional doctors’ sport of choice, golf. “It takes skill,” Fieno says. “You end up finding out how good you are at something where you’re not comfortable.” That is something that Fieno seems to crave. “I think everyone, every so often, needs to challenge themselves and step outside their comfort zone.”

Fieno recently learned to ski.

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HHS Publishes Guidelines on Cybersecurity By Angie Cameron Smith

This December, the U.S. Department of Health and Human Services Healthcare & Public Health Sector Coordinating Councils issued voluntary guidelines to assist healthcare providers assess cybersecurity risks and suggestions for mitigating those risks. The guidelines, entitled “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” were developed in response to the Cyber Security Act of 2015. The voluntary guidelines are a collaborative effort of HHS and 150 healthcare and cybersecurity experts. Their approach was threefold: (1) examine current cybersecurity threats, (2) identify weaknesses, and (3) provide practices to mitigate the threat. The guidance includes a “Main Document” and two “Technical Volumes” with appendices.

What’s Covered – Education and Prevention The Main Document is intended to raise awareness of cybersecurity issues facing the healthcare industry. It provides definitions and examples. The two Technical Volumes are intended for IT security professionals. Those volumes discuss the 10 cybersecurity practices to evaluate for mitigation of risks, broken down by size of the organization. Lastly, the resources and templates volume contains additional reference materials for healthcare providers dealing with cybersecurity. The group focused on the five most prevalent cybersecurity threats and 10 cybersecurity practices it felt were most

relevant to the healthcare industry. The five threats include: • email phishing attacks; • ransomware attacks; • loss or theft of equipment or data; • insider accidental or intentional data loss; • attacks against connected medical devices that may affect patient safety. For each of the five threats, the guidance defines the threat, provides a realworld scenario and then suggests the potential impact of each threat. It also gives tips for what to ask, when to ask and who to ask, if faced with the threat. The task force also identified potential vulnerabilities tied to each threat. According to the guidance, a threat is anything or anyone with the potential to harm something of value; whereas, vulnerabilities are the weaknesses that, if exposed to a threat, may result in harm and, potentially, some form of loss. The guidance includes ways to address your organization’s vulnerabilities. For example, with e-mail phishing, which is an attempt by a hacker to obtain sensitive or protected information using email, a potential vulnerability is a lack of awareness training. If your practice is the victim of email phishing, you could experience loss of reputation or loss of patients. The guidance then suggests practices consider addressing that vulnerability. This exercise is done for each of the five threats and provides great information that can be used not only to assess your practice, but also educate your staff on cybersecurity issues.

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cyber-threats is Ransomware. According to the HHS, this type of cyberattack has seen a steady increase since its appearance in 2016. Ransomware is a malicious software that attempts to deny access to data usually by encrypting the data with a key known only to the hacker until the data’s owner pays a ransom. HHS highlighted a Ransomware event that occurred at a rural hospital requiring it to replace an entire electronic health record system. Some of the statistics provided in the publication included • Four of five physicians have experienced some form of cybersecurity attack. • Small business constitute 58 percent of malware attack victims costing approximately $2.2 million on average. • A data breach costs the provider $408 per record. The guidance provides good information to establish training on the issue and a starting point for policies to help prevent cyberattacks. The Main Document, Technical Volumes and reference materials can be located at: https://www.phe.gov/ Preparedness/planning/405d/Pages/hicpractices.aspx. According to the website, Appendix E-1, which is a toolkit to help organizations prioritize their risks and develop an action plan using the methodology contained in the guidance, is still under development, but you can request an advance copy. Angie Cameron Smith is a Partner in Burr & Forman’s Health Care Industry Group.

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may have conditions that can be repaired outside of the study.” Study subjects return to CVA at one month, six months, a year and two years following the procedure, followed by phone check-ins at three, four, and five years. “The patients in the study are exceptional patients,” said Suzanne Frew, research coordinator with CVA. “This requires a commitment on their part to follow the regime. We need a buy-in from the patient.” “The follow-up is not onerous,” Roubin said. “We follow a standard of care that includes a Doppler study, but patients are not subjected to a lot of additional testing. The quality of care that is required and the detailed adherence to best practice protocols were built into these trials. “I believe that the reason CVA is number one in enrolling patients in this study is because there has been a commitment on the part of our entire group. We do everything we can to offer these patients state-of-the-art care. We want to bring this technology to patients as soon as possible, assuming it is, as we think it is, a superior way to treat peripheral artery disease.”

While the Main Document focuses on education, the Technical Volumes deal with prevention using the systems within the organization. There are ten cybersecurity practices or systems healthcare providers should evaluate: • email protection systems; • end-point protection systems; • access management; • data protection and loss prevention; • asset management; • network management; • vulnerability management; • incident response; • medical device security; • cyber security policies. The guidance does not rank these practices in terms of importance but states that the provider should determine through an assessment how it would evaluate the ten practices. According to HHS, one of the key aspects of analyzing your cybersecurity needs is determining what size practice you would be under the guidelines. To assist with this analysis, the guidance provides a chart that allows you to determine the best fit for your organization when assessing your cybersecurity needs. After determining the size of your practice, the provider is then able to choose between volume one for small providers or volume two for medium or large providers. Each volume contains a series of practices for the provider to evaluate within its organization. These are essentially best practices.

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New Products Help Hemophilia Patients, continued from page 1 with hemophilia at birth, others may not be identified until later in life. “About 70 percent of patients have a family history of hemophilia, but the other 30 percent have a new mutation that isn’t present in their family history,” Stolz says. “For those with Christina Bemrichno family history, we often discover the dis- Stolz, MD, MSPH order when baby boys are circumcised and the bleeding is not well controlled, which prompts an evaluation.” Hemophilia is most frequently found in males. “It’s a factor deficiency disorder,” Stolz says. “The factor 8 and factor 9 genes are on the X chromosome, so if you are a female, you have two X chromosomes. If there is a mutated factor gene on one chromosome, the normal X chromosome supports it and makes up for the factor that is missing from the mutated chromosome. “Since a boy has only one X chromosome, if he receives a mutated X chromosome from his mother, he will have hemophilia. However, 30 percent of the time, it will be a new mutation that wasn’t inherited and we would have no reason to suspect hemophilia unless there is unexpected bleeding.” Because bleeding is the main issue with hemophilia, most of the complications these patients experience are because

of the bleeding. “Bleeding can be life threatening,” Stolz says. “Before we had good treatment options, patients would have frequent and significant joint bleeds. Repeated bleeding in a joint will result in damage to the joint, and many patients would have difficulty walking or be in wheelchairs. We now know that we can prevent some of the bleeding by giving factor prophylaxis to these young men. Studies have shown that it decreases joint bleeding and disability in those patients.” Adler praises the factor products that are available today, especially the recombinant products designed to raise factor 8 levels which decreases joint bleeding. He remembers the 1980s when many young men with hemophilia contracted HIV through donor plasma. “Because of the purification problem back then, there was no way to screen the donor blood,” he says. “Unfortunately, a lot of hemophilia patients developed HIV and died in the early 80s and 90s. Now the purification process is extremely good, and I don’t think we’ve had a transmission of HIV in decades. Thanks to the recombinant products, the safety is excellent now.” A recent international randomized study looked at the development of inhibitors in patients that received plasmaderived factor (from donated plasma) as opposed to recombinant factor. Improved donor screening and viral inactivation processes have made plasma much safer

that it was in the 1980s. Inhibitors, or antibodies against factor 8, are a serious medical problem that can occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates. Sometimes a person’s immune system reacts to proteins in factor concentrates as if they were harmful substances because the body hasn’t seen them before. In that case, the body prevents the factor concentrate from fixing the bleeding problem. “The studies showed that the risk of an inhibitor is less in patients who received plasma-derived factor as opposed to recombinant factor,” Stolz says. “If a patient develops an inhibitor to their factor, they no longer respond to infused factor, and we have to use different medications to treat them if they are bleeding. These medications aren’t as effective as factor and the patients receiving the medicine have more bleeding than people without an inhibitor. “So we now know that patients who receive the recombinant factor are more at risk of developing an inhibitor than those who receive plasma-derived factor. However, we have been using these recombinant products for years, so we know it is safe. If families are uncomfortable using the plasma drive products, this is another option for them.” In the past few years, a new product for factor 9 deficiency has been approved and is longer lasting than others. That

means that some patients who usually do twice-a-week factor prophylaxis now can extend treatments to every two weeks. “In October, another new product called emicizumab was approved, and I am offering it to my patients with factor 8 deficiency,” Stolz says. “It is a bi-specific antibody that acts in a similar way to factor 8. It is not factor 8 itself. It just does the same work as factor 8. The advantage of emicizumab is that it can be administered with a subcutaneous shot that is given once a week.” There also are three new subcutaneous injection products currently undergoing trials for factor 8 or 9 deficiency. “There are phase two studies underway for patients with either factor 8 and 9, so we are going to have a lot of options for these patients soon,” Stolz says. “I tell the parents of new patients to keep seeing me, because we soon will have a lot of treatment options.”

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Love and Health By Laura Freeman

There must be something in those Valentine chocolates that is good for you. After all, married people on average tend to live longer. Statistically, those with significant others in their lives also have fewer colds, stronger immune systems, spend fewer days in the hospital and even seem to do better in later years when dealing with neurodegenerative disorders. Love can help you live a longer, happier life. It isn’t the passionate first blush of love that brings the benefits. It’s the warm strength of abiding love that protects wellbeing. “People who have a satisfying, committed relationship are the ones who live longer,” UAB behavioral scientist Josh Klapow PhD said. “The support of this kind of love helps to buffer stress. These couples tend to watch out for each other and give each other the nudge they need to go to the doctor to get a problem checked out. People in caring relationships tend to take better care of themselves when they know their well-being matters to someone else.” Josh Klapow, PhD While taking the time to cook a healthy meal for yourself can seem like too much trouble, cooking meals to share with people

whose health you want to protect can become a regular family routine. Likewise, being active is more enjoyable and more likely to happen when it is shared. “Humans evolved as social beings with a need for connectivity,” Klapow said. “It doesn’t have to be marriage. Close friendships can also make a difference. A satisfying relationship has positive health benefits. On the flip side, a miserable relationship can have a negative effect on health.” Being alone isn’t the same as being lonely. Alone time can allow contemplation to assess, create and plan. On the other hand, loneliness is linked to depression and poorer health. In today’s social structure, more people are alone and at risk of the negative effects of loneliness. More people are

remaining single or become divorced. Extended family may live far away. Between work, commuting and the demands of daily life, finding time for social interaction can be difficult. “We have more ways to connect than ever, thanks to technology” Klapow said. “It can help us stay in touch, but that is not the same as touching. It’s no substitute for being with other people, and it can make us feel lonelier when it looks like everyone else is enjoying things that we’re missing.” Humans need to connect with another person, to feel valued, loved and to give love. “It isn’t necessary to have a lot of relationships,” Klapow said. “But we do need a few people in our lives with whom we share a connection.” When someone has limited opportunities to interact with others, the companionship of pets can help. Nursing home patients and autistic children tend to respond positively to pets. “Pets can add affection, but they are not a complete substitute for human connectedness,” Klapow said. Any love that begins will eventually end, and in most cases, one partner will be left behind. So how do we keep love in our lives? “You need to surround yourself with a network of caring relationships that will be there to support you after a loss,” Klapow said. “These relationships need to be nurtured throughout life. Accidents and

fatal illnesses can happen to anyone at any time.” Life is change, and we need to grow with those changes. Children grow up and we lose old friends to time and distance. We need to pursue activities we enjoy so we continue to meet new people who share our interests. This might include moving to a retirement community as we age, where there are more people to meet and easier access to stimulating activities. Love is a human need that begins at birth. Babies who fail to bond may fail to thrive. “We need to model what love is in front of our children,” Klapow said. “When we argue, we should tell our children we still care about each other even if we have our differences. If the relationship ends in divorce, they should know we still have respect for each other. “Children need to understand that relationships aren’t just about receiving love and having a need fulfilled. It’s also about giving love and respecting the beloved’s autonomy as an independent person. “We need to start early teaching our children how to be loveable. They need to feel secure in our love for them, and we need to teach them empathy and respect for other people. They should learn that the world doesn’t revolve around them. There are other people in the world, and making a two-way connection can be satisfying. It’s the first step toward enjoying a healthy lifetime of love.”

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Updated Cholesterol Guidelines, continued from page 7 on a high intensity statin. For those with diabetes between the ages of 40 and 75, no matter what the LDL number, the updated guidelines continue the 2013 recommendation for them to be on a statin, as well. He added, “Those who have longstanding diabetes or are older than 50 may do better on a higher intensity of statin.” The new guidelines call for a more nuanced approach to statin use in the largest group – those 40 to 75 without diabetes or the highest LDL-C. Stone said by virtue of four different clinical trials assessing 10-year risk, individuals with a score of 7.5-19.9 percent should at least be considered for statin therapy. He added, those with a score of 5 percent or less typically don’t need statins, and those with a score of 20 percent or higher on the risk calculator should automatically be on statin therapy. “The previous guidelines recom-

mended a clinician-patient risk discussion before a statin was given,” he said of the borderline group. “The new guidelines also recommend a clinician-patient discussion, but they give more details of what that should be. The idea is to provide a way for doctors to give patients, who aren’t sure whether to take a statin, factors to show a patient what their personal risks are.” In addition to traditional risk factors like smoking and high blood pressure, the new guidelines outline a number of other risk-enhancing factors to consider, including: family history and ethnicity, LDL≥ 160, triglycerides persistently above 175, premature menopause or pre-eclampsia, chronic inflammatory conditions such as rheumatoid arthritis, metabolic syndrome, and chronic kidney disease. A coronary artery calcium (CAC) score can also help tip the scale on

whether or not to start statin treatment immediately. A CAC of zero has typically indicated a low risk of CVD, which has been borne out by two large-scale studies. “We are not recommending calcium scores as a screening test,” Stone stressed. “We’re using it as a tie-breaker … it can be the decider,” he added. “Someone with a (risk assessment) score of 9 percent, few other risk factors, and a coronary calcium score of zero may wish to postpone statin use for five to 10 years because their risk is relatively low,” Stone continued of using the personalized approach at the heart of the new guidelines. For everyone, no matter where their risk assessment percentage falls, he stressed the importance of lifestyle modification to either delay or prevent the need for statins or to enhance the work of statins in maintaining heart health. “We point out even

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COM I SOO NG N

if you’re on a statin, you need to focus on lifestyle because the lower you can get your number on a statin, the lower your risk,” stated Stone.

Secondary Prevention For individuals who have already suffered a heart attack or stroke, the new guidelines call for additional intervention when LDL-C is not well controlled. “We have three trials showing if the LDL is above 70 in people who are very high risk, they might benefit from not just a maximally tolerated statin but also the non-statin ezetimibe or PCSK9 injection or shot,” explained Stone. He added the recommendation is for a stepwise approach. Stone said the addition of ezetimibe would get a significant portion of high-risk patients under the 70 LDL benchmark. Available as a generic, ezetimibe is typically affordable and well tolerated by patients. For those who cannot achieve the desired goals with a combination of statin and ezetimibe, a PCSK9 inhibitor could be added. The new guidelines also note a PCSK9 inhibitor might be added as a primary prevention tool for individuals who have a genetic condition that causes high LDL-C. However, Stone noted, the shot is considerably more expensive. Some insurers have been slow to cover the treatment, although there has been movement in recent months to lower the cost. The AHA and ACC are bringing together stakeholders to further discuss financial barriers to achieving optimal primary and secondary prevention of heart disease and stroke. For All Once treatment has started, whether lifestyle modification only or modification with medication, physicians should schedule a follow-up appointment within four to 12 weeks to assess adherence and effectiveness with a fasting lipid test. The guidelines then call for retesting every three to 12 months, depending on determined needs. Stone said the new guidelines recognize and address the cumulative effects of high cholesterol over a lifetime. In most children, an initial test could be administered between the ages of 9 and 11. For some children with a strong family history of heart disease and high cholesterol, selective cholesterol testing might be appropriate as young as age two. While most children won’t need medication, physicians should use the test to discuss the positive impact healthy behaviors have on lifetime CVD risk. The updated guidelines offer a more individualized method to controlling cholesterol. “Before, it wasn’t a one-size-fitsall approach, but everybody thought if you had a score of 7.5 percent or more, you automatically go on statin therapy. The new guidelines really make it clear how to use enhancers to personalize the risk discussion,” Stone concluded. For a link to the new guidelines, please go online to birminghammedicalnews.com.


Before The Damage Is Done

Proactive Medicine Is Helping Us Live Longer. Could It Make Those Years Better? Thanks to screenings, labs, vaccines, imaging and earlier interventions, many of us who, in previous generations, would have died in middle age from heart or lung disease, cancer, infections or a host of other disorders are living well into old age. However, the proactive approach that is helping us live longer hasn’t caught up to the long arc quality-of-life disorders that have such a negative impact as we age. Take osteoarthritis, for example. Think back to the last time you went to your physician for a checkup. Review vital signs and Amit Momaya, MD works with a patient. listen to heart and lungscheck. Labs for A1-C and lipids—got it. Maybe a flu shot. But has been paid on a fee for service basis, like anyone ever checked the wear pattern taking your car to a garage when it’s runon the bottom of your shoes? Have they ning rough, or going to a lawyer in a conwatched you walk for signs of a patella mistract dispute. Most healthcare coverage alignment or looked for a biomechanical has been oriented toward fixing a problem problem in your back that is putting extra rather than preventing it,” Irfan Asif, MD, pressure on your joints? chair of UAB’s Department of Family and “Up until recently, health care has Community Medicine, said. “That is be-

ginning to change as we move toward a new model that rewards physicians for keeping patients well rather than just treating a disease. “We’re already seeing progress toward reimbursement for preventive medicine and screenings. Eventually, the system is likely to become more proactive in early detection and intervention in correctable factors that contribute to chronic conditions that cause pain, limit function and increase health care expenses.” Two other major barriers stand in the way. Much can go wrong with the human body, and there isn’t enough time in physician training for everyone to learn everything. As research uncovers more information about biomarkers for earlier detection of disorders like Parkinson’s Disease, Alzheimer’s, depression, cognitive decline and the effects of stress, there will be much more to learn and then to implement that knowledge in patient care. “We are moving toward working more

closely as a team, especially in primary medicine. This can give physicians the support of other disciplines to care for patients as incentive turn toward rewarding providers for keeping people Irfan Asif, MD healthy,” Asif said. As reimbursement moves toward a value-based system, it may become common to send patients to physical therapists or orthopedists for a baseline assessment to check for biomechanical issues that might be correctable to prevent the need for surgery or medications that might come with side effects that can complicate care. Instead of just telling patients to lose weight, we may be able to send them to a nutritionist and trainer. Instead of worrying about the physical effects of stress and depression on patients, physicians can refer them for the support they need. This assumes that there are enough psychiatric and social support professionals to provide care and reimbursement resources to cover it. It also brings up the second major barrier to a more proactive approach to chronic diseases. There aren’t enough pri(CONTINUED ON PAGE 14)

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Before The Damage Is Done, continued from page 13 mary care providers now to care for patients and not enough time in a doctor’s day to do proactive extras. “Across the country, we have a shortage of primary physicians and one of the worst shortages is Alabama,” Asif said. “If nothing changes, the shortage is expected to be more than 600 by 2030. That is only 11 years away. Part of this shortage grew out of a system with more incentives for treating a disease rather than preventing it. The shift toward a value based system aimed at keeping patients healthy should help, but we also have to look at the rewards that will attract more providers now in training to primary care.” Even if the shift to more proactive care happened tomorrow, it would only be half the equation. It takes a partnership between physician and patient to build a lifetime of better health. The day-to-day efforts required depend on the patient. Unfortunately, bodies don’t come with an owner’s manual and education has been limited. Sports medicine orthopedic surgeon Amit Momaya, MD, is a team physician for UAB athletics and for John Carroll High School. “Mineral density in the bones peaks at age 25 and then begins to decline,” Momaya said. “I try to make sure that young athletes understand the importance of continuing to move after they graduate. Bodies need both aerobic and strength-building exercise slow the decline of mineral density

and to keep muscles strong to support joints. In later years, it is important to keep muscles strong to aid balance. A fall and broken hip can lead to a devastating decline in health. “The type of work we do can have a major effect on our joints and bones later. If people do a lot of standing or lifting, they need to have the right footwear and equipment and know the right way to do it. And long hours at a desk can lead to lower back problems. People need to stand up every 15 minutes or so, stretch and walk around a bit. Try a standing desk to see if it feels better. Also think about nutrition. Too many people are just not getting enough vitamin D and calcium.” Whatever people can do to delay or prevent the need for surgery later can be a good investment. “We have come a long way in joint replacements, but they don’t last forever,” Momaya said. “If you need a replacement early, you may need another replacement later. Revision surgery is often more complicated and may not be as successful. It may also be needed at an age when you have other conditions that makes surgery difficult.” UAB researchers are looking for a way to use stem cells to regenerate cartilage and prevent the need for surgery. That goal is yet to be achieved, but some studies are offering hope for relief of symptoms. Other injectables, including steroids, platelet rich plasma, and hyaluronic acid are being used

with other conservative treatment to postpone surgery. UAB rheumatologist Laura Hughes MD, MSPH, joins Asif and Momaya in agreeing that the course of osteoarthritis and mobility in later life depends greatly on patients following through with positive health behaviors. “There are genetic influences in some types of osteoarthritis, but we usually find that in the hands, neck and upper body,” Hughes said. “Hips Laura Hughes, MD, and knees are primarMSPH ily a load issue, either the weight of the body or how that weight is aligned. Patients should be encouraged to control their weight. Every pound they avoid can save four pounds of wear on their knees. As healthcare turns toward a more preventive approach to chronic conditions like osteoarthritis, what can physicians do here and now to help patients? “There are some observable clues that patients may be having alignment issues,” Momaya said. “If they stand with one knee bent more than the other, have an unusual gait or a knee that tends to turn inward or outward more than usual, you may want to take a closer look. There may be pain or swelling. If there are unusual wear patterns on the soles of shoes, they may need

orthotics.” Although physical therapy can help with these issues, some patients might not be able to afford it. Are there alternatives? “Free handouts for physical therapy exercises are available from professional associations related to rheumatology and joint surgery,” Hughes said. “And medical centers and physical therapy groups put videos online demonstrating how to recognize problems and the right way to do exercises to ease them. It could be helpful to get recommendations of video sources from physical therapists and list them on handouts available to patients.” Asif is working on an outreach program to bring the benefits of activity to a broader population and hopes to involve civic groups like the YMCA. By starting young, perhaps we can spare future generations from the pain and limitations.

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Sharing Data, Saving Lives Hospitals Release Agenda for Interoperability By CINDY SANDERS

Last month, seven of the nation’s leading hospital associations released a report calling for stakeholders to come together in a quest to accelerate healthcare interoperability. In an increasingly connected medical ecosystem where patient safety, health status improvement, and provider reimbursement are impacted at every point along the continuum, the need to efficiently, securely share data appears to have reached a tipping point. Sharing Data, Saving Lives: The Hospital Agenda for Interoperability outlines pathways to address interoperability among health information technology systems to achieve the triple aim of improving the patient experience and the health of populations while reducing the cost of healthcare. The American Hospital Association (AHA) and Federation of American Hospitals (FAH) were joined by America’s Essential Hospitals, Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association and the National Association of Behavioral Healthcare to craft the call to action. “We see interoperability all around us,” pointed out AHA President and CEO Rick Pollack. “Mobile phones can call

each other regardless of make, model or operating system. The hospital field has made good headway, but it’s time to complete the job.” FAH President and CEO Chip Kahn added, “Quality care depends on having the right information at the right time, so our patient’s records need to be available in the hospital or wherever our patients receive care.” While there has been progress in sharing health information over the past decade, the report outlines six pathways critical to meeting the demands of truly connected care: • Security and privacy, • Efficient, usable solutions, • Cost effective, enhanced infrastructure, • Standards that work, • Connecting beyond electronic health records, and • Shared best practices. FAH Vice President and Associate General Counsel Erin Richardson noted interoperability has been an issue for a long time with hospitals and clinicians having to deal daily with an inability to get or move records, track patients through the broader system and close the gap on referrals, among other concerns. Richardson, who was part of the report work-

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group, added it made sense for hospitals to take a leadership role in addressing these problems. “Hospitals and healthcare systems are the big purchasers of health informaErin Richardwon tion technology from EHRs to devices,” she pointed out. “It means we have tons of data but aren’t necessarily able to use it in the best way.” Richardson added the mindset has to change around interoperability. “We talk about it as if it’s an endpoint, but we need to think of interoperability as a tool to improve care.” She continued, “We want to be able to move that data and use it to help our clinicians make better decisions.” There are a number of issues, Richardson said, that have proven to be barriers to interoperability over the years. “Some providers don’t have EHRs because they were not included in the HITECH Act,” she noted of the 2009 law that provided financial incentives to assist many clinicians in switching to electronic health records. Notably, post-acute and behavioral health providers were left out, and some of those clinicians still lag be-

hind their counterparts in other industry sectors in adopting digital solutions. “You can have a lack of infrastructure,” she continued of another prominent barrier to interoperability. “For example, different systems … that use different standards for how data is moved and recorded … can create a misalignment.” Another key issue, Richardson added, is the current inability to match patients and records easily in the absence of a national identifier. There might be five John Smiths who have been a patient in a single hospital, dozens more in the community, and thousands with that name across America … and all of their records need to securely and accurately travel with them as they move about the country. In the age of the healthcare hack, Richardson said it also was critical to focus on concerns around the safe movement of data. “Security and privacy have to be embedded everywhere … it’s not an afterthought,” she stated, adding security has to be built into every single layer of an application program interface. “This has to be foundational,” she stressed. “The usability of health information technology (health IT) must also be addressed,” she noted. “Clinician complaints about spending more time with the EHR (CONTINUED ON PAGE 16)

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Grandview Electrophysiology Lab, continued from page 4 blood thinners. “A lot of patients cannot take thinners because of contraindications, leaving them unprotected,” Osorio says. “The LAA closure is designed for these patients.” The 30 to 60-minute procedure walls off the blood pooled inside a little pouch, called the appendage, inside the atria. That blood can clot, dislodge and cause life-altering or fatal strokes. The LAA closure dams up that pouch. The procedure starts by threading a tiny device through the major blood vessel in the groin up to the heart. “It looks like a little umbrella. We open that in the mouth of the appendage and leave it there,” Osorio says. Within a few weeks, the heart tissue grows over the umbrella and completely occludes the opening. The thousands of procedures by Grandview’s EP lab reflect the area’s need. “Alabama lies in the buckle of the Stroke Belt. We have a high incidence of atrial fibrillation,” Osorio says. “But a large part of our patients are not coming from Birmingham.” He estimates about 70 percent treated in the lab travel from Mississippi, Tennessee, Georgia and Florida. Osorio says that although other EP programs in the region are capable of doing the same procedures, it is Grandview’s quest for quality based on meticulous data collection that produces efficacious outcomes. “We have success rates as good as any other center in the country, if not better,” he says. Their success in treating early-stage (paroxysmal) atrial fibrillation in a single procedure is 85 percent. When adding in the success from those who may need a second procedure, the success rate for

make patients feel better. Osorio disagrees with that approach. “20 percent of strokes are because of atrial fibrillation,” he says. “Decreasing the risk of stroke should be the focus, along with making patients feel better.” Osorio says it wasn’t long ago that patients with early-stage arterial fibrillation were told they could live with the condition and no treatment. “But we have more data now, and it shows this affects a lot of patients,” he says, adding that only about 50 percent of the patients they see in the lab are in the early stages of AFib, which is usually progressive. “So we’re not appreciating the degree for which this can affect patients, their quality of life, and overall mobility—and risk for strokes. The right treatment for a patient can absolutely decrease the risk of stroke.”

Sharing Data, Saving Lives

The EP Lab team.

treating early-state AFib rises even higher. The rates drop for treating more complex AFib, such as persistent or permanent which, according to Osorio, shows that patients need to be seen sooner. The value of seeing an EP may be underestimated by patients and the medical community alike, especially in the early

stages of AFib. But a 2014 study published by the National Institutes of Health on AFib treatment patterns of cardiologists and electrophysiologists, showed the approach by EPs differed significantly and resulted in half the mortalities. Treatment for AFib often focuses primarily on mitigating the symptoms to

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than with their patients and the number of ‘clicks’ it takes to perform a task are well-documented and concerning.” Richardson said the first goal of releasing the report was to put the organizations’ ideas and agenda ‘out into the world’ to foster broader conversations among stakeholders about how best to move forward. “It’s also a way for us to examine and engage with what others in the private sector, as well as at a federal level – CMS & ONC, are doing to advance interoperability. It gives us a foundation to determine how those efforts line up with the areas we’ve identified,” she explained. By addressing barriers and adopting industrywide standards to safely, securely transmit and receive usable data, the hospital associations believe improved interoperability should advance high-quality, patient-centered care and have a positive impact on outcomes. At its best, interoperability should provide a fuller picture of an individual’s health by utilizing information from disparate sources capturing both medical and social determinants data and allowing that information to flow seamlessly across care settings. Furthermore, the hope is that by aggregating and deidentifying data, clinicians should gain a clearer picture of population health issues and workable innovations. A link to the full report is available online at NashvilleMedicalNews.com.

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Birmingham Medical News

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The Mandate-less ACA: Unconstitutional? By Chris Thompson

The foundations of our national healthcare law do not strike observers as particularly stable. The laws and regulations scaffolding the delivery of healthcare are constantly evolving at best, and a shifting morass at worst. Part of this is a function of healthcare itself: the provision of healthcare is an always-developing profession, with new technologies, procedures, drugs, and knowledge ever arriving on the scene. Yet the ideological divide among policy-makers and the public regarding the appropriate way to orient the healthcare systems’ fundamental goals continues to add uncertainty to the landscape. Over the past decade, this divide has been most clearly seen in the passage of, and subsequent challenges to, the Affordable Care Act (ACA). Since its passage in 2010, contests over the ACA have taken place within legislative venues, at the Supreme Court, in newsrooms, and across the spectrum of public opinion. Given the results of the 2018 midterm elections, these struggles are unlikely to gain legislative resolution over the next two years. While the Trump administration’s criticism of the ACA is well established, little movement can be expected from a divided Congress. However, there may be potential for more significant developments on the judicial front, triggered by a recent federal court decision in Texas that ruled the ACA unconstitutional. This decision could ultimately put the law’s fate back in the hands of the Supreme Court. On December 14, Texas U.S. District Judge Reed O’Connor, ruled against the ACA and in favor of a coalition of states, who had brought a challenge to the ACA with the backing of the Trump administration. Judge O’Connor held that due to Congress’s repeal of the individual mandate in the 2017 tax bill, the ACA should be struck down in its entirety. The individual mandate had been a key component of the ACA and a key point of criticism for the ACA’s opponents. While the decision itself had little immediate effect--the ruling did not include an injunction, the health care exchanges remained open, and the ACA is still in effect as far as the U.S. Department of Health and Human Services is concerned--the case’s fate on appeal may prove more momentous. The first destination of such an appeal is the Fifth Circuit. The ultimate destination, perhaps a year or two in the future, rests with the Supreme Court. While there is no guarantee that the Supreme Court would take up this case and decide another challenge to the ACA (following its decisions on other facets of the law in National Federation of Independent Business v. Sebelius in 2012 and King v. Burwell in 2015), this is a definite possibility. Predicting the eventual treatment by the justices depends largely on considering two types of changes since the earlier ACA decisions: changes in personnel and changes in the law. Any change in personnel at the Supreme Court is worth attention, and there

are two new justices on the Court since the last Roberts opinion on the ACA was issued: Justice Gorsuch has replaced the late Justice Scalia and Justice Kavanaugh replaced Justice Kennedy. While the latter change represents an apparent ideological shift in the Court--the swing vote Kennedy has been replaced by a justice who is expected to be fairly reliably conservative--this new conservative majority is unlikely to be a deciding factor when it comes to the ACA’s fate. This is because Justice Kennedy sided with the conservative justices in Sebelius. Justice Roberts wrote the majority opinion upholding the law. With regard to the ACA, Justice Roberts has shown every sign of deferring to congressional intent, and all else being equal a drastic change is unlikely. All else is not, however, necessarily equal. The ACA that would be scrutinized by the justices in 2019 or 2020 is not the same ACA that was saved by Roberts in 2012. Further, as Judge O’Connor opined, the present case involves the intent of two very different Congresses: those of 2010 and of 2017. The changes in the law, then, appear to be more significant than changes in personnel. The pivotal change, as noted above, is the repeal of the individual mandate through the 2017 tax bill. This got rid of the feature of the ACA that was deemed a tax by Justice Robert in his 2012 opinion, thereby allowing the ACA to weather constitutional challenge. Insofar as the ACA was valid in 2012 due to the taxing power properly exercised by Congress in the form of the individual mandate, the excision of this mandate would appear to pave the way for a challenge almost custom-tailored to Justice Roberts’s pen. A 2012 majority rejected, after all, the Obama administration’s argument that Congress had authority under the Commerce Clause to enact the ACA as it then stood. Therefore there is now ambiguity as to what constitutional power is left to support the ACA in its current form. This argument may oversimplify Justice Roberts’s position in 2012 on the mandatetaxing power and undervalue his tendency to let the American people, through their representatives in the legislative branch, decide the fate of the ACA. However, it gives opponents of the ACA enough material to believe the law could be struck down, and it gives supporters of the law some anxiety. Depending on this case’s fate at the next level of appeal, this issue could become a point of contention leading up to the 2020 election, although each side’s position on the ACA and health insurance in general are well enough entrenched by now that the possibility of another Supreme Court decision might not tip any scales. Both sides are currently waiting, but in the interim there are no significant changes to be managed for providers, patients, and the public in general. Chris Thompson is an associate in the health law practice in the Waller Birmingham office.

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FEBRUARY 2019 • 17


The Literary Examiner BY TERRI SCHLICHENMEYER

(Don’t) Call Me Crazy by 33 authors, edited by Kelly Jensen c.2018; $16.95; 228 pages Ouch, you twisted your shoulder and it hurts. That’ll last awhile, but you’ll be okay. It might need a sling, but it won’t cramp your style. Your friends will help. That’s what people do when someone’s hurt and they see that’s the case – but what about the illnesses they can’t see? In (Don’t) Call Me Crazy, an anthology edited by Kelly Jensen, you’ll read about diseases that often stay invisible. Hang around older folks for more than a minute, and you might hear them mention their arthritis, bad back, bad knees, and other aches and pains. They do it openly because we have no problem talking about physical hurts or disabilities. So why is it hard to talk about mental health? It shouldn’t be. People deal with mental health issues all the time, and saying they’re “crazy” can mean different things. It can include an aversion to sounds or a way of looking at one’s body. It can be sadness or compulsion.

Overall, though, the thing to remember is that even when it feels the messiest and most overwhelming, “crazy” does not define an individual, no more than heart disease or any physical problem defines a person. It is also possible that you don’t know you have mental illness. That happens. You go about your life, enjoying your quirks until someone says you’re “crazy,” and you go look it up. And you are surprised to find that your quirk is in a book somewhere and you learn, to enormous relief (and maybe illplaced embarrassment), that you’re not alone in this. And that’s the whole point: you’re not alone. Whatever you’re feeling, there is a chance that someone else has been through something similar. They’re not you, but they know your mania, your body dysmorphia, your OCD or PTSD or depression or anxiety or the isolation all these things might bring. They know and

they’ve survived. They understand that there is someone who can help. Baby steps. That’s the simple takeaway from (Don’t) Call Me Crazy: just two words that a teen will learn when facing mental illness. It takes thirtythree voices to get there, and each one hammers across the point – some with humor, others with fear that leaps between a reader’s hands, and still others that offer a facts-only account that will comfort readers who don’t want embellishment. The writers featured here come from different backgrounds, including those of color and a trans woman, all of whom are the least-discussed in mental health conversations.

The biggest help, though, comes from the sense of community that this book offers in the form of stories from survivors and those who are works in progress. Either overt or implied, the words “it’s okay, you’re not alone” are everywhere in this book. Though it’s meant for 12-to-20-yearolds who need its compassion, this book is a good start to an adult conversation. (Don’t) Call Me Crazy could also offer good insight for professionals, parents, and friends to help shoulder the pain. Terri Schlichenmeyer is a professional book reviewer who has been reading since she was 3 years old and she never goes anywhere without a book.

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Birmingham Medical News

Weily Soong, MD Maxcie Sikora, MD John Anderson, MD Sunena Argo, MD William Massey, MD Carolyn Comer, MD Lorena Wilson, MD Njeri Maina, MD


GRAND ROUNDS

Brookwood Baptist Medical Center Announces Medical Staff Officers and Department Chairs Russell Ronson, MD Elected Chief of Staff

Participants spent the day in medmod training.

Participants spent the day in medmod training.

Kassouf Holds Modernizing Medicine Workshop On January 31st, Kassouf & Co held a Modernizing Medicine Workshop which is designed to provide training and additional information for Dermatologists, Plastic Surgeons, and staff on using the modmed Dermatology Practice Management EMR Suite. The one-day training event, which was led by an EMA™ Software Educator, a Practice Management Educator, and a MIPS Supervisor, included collaborative discussions, scenario-based exercises, and recommendations on how to best leverage the latest enhancements to the suite. Are you interested in improving practice efficiencies and workflows? Do you feel as if you’ve missed out on new features? Your Modernizing Medicine EMA™ and Practice Management Software Educators are here to help!

Brookwood Baptist Medical Center has announced the hospital’s 20192020 Medical Staff officers and department chairpersons. These physicians, who were elected by their peers, began their tenure effective January 1 and will serve a two-year term. Their responsibilities include playing an important role in the hospital decisionmaking process, working collaboratively with the Board, Administration Dr. Russell Ronson (left), incoming Medical Staff and Medical Staff. The Medical Staff President, and Dr. Brian Adler, outgoing President. organization helps to better define and monitor processes for physician credentialing, evaluation, peer review and discipline. The 2019-2020 officers and chairpersons are: Officers • President - Russell S. Ronson, MD - Cardiovascular & Thoracic Surgery • Vice President/Credentials - Matthew Sherrer, MD - Anesthesia • Vice President/Quality - Mark Adams, MD - Internal Medicine Department Chairpersons • Anesthesiology - Matthew Sherrer, MD/Justin Routman, MD • Emergency Medicine - Kraig Johnson, MD • Medicine - Stephen Bakir MD • OB/Gynecology - Greg Banks, MD • Pediatrics - Vick DiCarlo, MD • Pathology - Warren Clingan, MD • Radiology - Stuart Siegal, MD • Surgery - Marc Routman, MD “I have been a practicing cardiovascular and thoracic surgeon at this hospital for 17 years, and I look forward to the opportunity to serve alongside my peers and help continue to drive the standard of care at Brookwood Baptist Medical Center,” stated Brookwood Baptist Medical Center Medical Staff President, Russell Ronson, MD.

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GRAND ROUNDS

Van McGrue Named CNO of Citizens Baptist

Grandview Holds Ribbon Cutting Ceremony for 12th Floor In January, Grandview Medical Center hosted a ribbon cutting for the 12th floor of the hospital. In 2018, Grandview obtained a Certificate of Need to construct 30 inpatient beds. Phase I of the construction is completed and Phase II should open in this March. The completion of both Phase I and Phase II of the project will bring the total liThe ribbon cutting (l-r) T.C. Brightbill, MD; James Spann; Drew Mason, censed beds for the David Wynne, MD; and, Kayla Knight hospital to 402. “Grandview continues to build its physician network and broaden its footprint in the region,” said Drew Mason, CEO of Grandview Medical Center. “We are excited to continue investing in the quality of our clinical team and physicians.”

Van McGrue has been named Chief Nursing Officer (CNO) of Citizens Baptist Medical Center. With over 25 years’ experience, McGrue has held a number of managerial roles in both private and public healthcare. She began her career in Talladega in Van McGrue 1992 at the Northeast Alabama Kidney Clinic and previously worked for Citizens Baptist Medical Center for several years in the late 1990’s. Following a decade in private healthcare administration with oversight of territories from Alabama to Georgia, as well as Tennessee, McGrue rejoined Citizens Baptist Medical Center in 2009 as the Infection Preventionist before

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Birmingham Medical News

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being named Director of Outcomes. In this role, she was pivotal in improving reimbursement by six percent within six months following the implementation of the CDI program. McGrue later served as Management Director of Nursing for Medical Surgical where she contributed to achieving the highest improvement in Hospital Consumer Assessment of Healthcare Providers and Systems at Citizens Baptist for the first six months of 2015. McGrue holds a bachelor’s degree and master’s degree in nursing from Jacksonville State University. She serves on the Board of the Alabama Kidney Foundation and is a member of the American Nurses Association, Association of Perioperative Nursing and Association of Professionals in Infection Control and Epidemiology, as well as the American Nephrology Nurses’ Association. “Van has proven herself a compassionate and dedicated nursing professional with a breadth of experience that allows her to successfully lead others through the actions she demonstrates,” said Citizens Baptist Medical Center CEO, Frank Thomas.

Almost Half of Adults Have High Blood Pressure Nearly half of American adults have high blood pressure, according to a new report by the American Heart Association which found that 45.6 percent of adults were hypertensive between 2011 and 2014 under the new blood pressure guidelines released in 2017. Under the previous guidelines, only 31.9 percent of United States adults had high blood pressure during the same time frame. Paul Muntner, PhD, an epidemiologist at the University of Alabama at Birmingham School of Public Health and Vice-Chair of the American Heart Association’s statistic committee, says the increase is due to the recently updated American College of Cardiology and American Heart Association hyperten- Paul Muntner, PhD sion guideline, which lowered the blood pressure levels used to define hypertension from 140/99 mm Hg to 130/80 mm HG. While the increase in adults with hypertension may seem alarming, Muntner says the new guidelines will make people more aware of their health. The number of adults living with a cardiovascular disease also increased. The report found that at least nine percent of U.S. adults had cardiovascular disease defined by a coronary heart disease, stroke or heart failure. If hypertension is included in the list of cardiovascular diseases, the total percentage increases to 48 percent, or 121 million, of U.S. adults living with some type of cardiovascular disease in 2016. The report lists heart disease as the number one cause of death and stroke as the fifth leading cause of death in the United States in 2016.


GRAND ROUNDS

UAB MSHA Program Wins Award The Master of Science in Health Administration program at the UAB school of Health Professions has been acknowledged for excellence by the Commission on Accreditation of Healthcare Management Education as the winner of the 2019 CAHME/Baylor Scott and White Health Award for Excellence in Quality Improvement Education. The honor recognizes the UAB MSHA program for embedding quality throughout its curriculum, for incorporating practitioner faculty in experiential learning, and for its collaboration with UAB Health System on a Student Workforce Program that gives first-year students real-world health care experience. “We are delighted to receive this recognition,” said Amy Landry, PhD, Howard W. Houser Endowed Professor in Health Administration and MSHA program director. “We try to emphasize the importance of quality improvement and patient safety throughout our curriculum.” This is the second year in a row that CAHME has honored the UAB MSHA program. In 2018, the program received the 2018 CAHME/Cerner Award for Excellence in Healthcare Management Systems Education.

The Breast Cancer Research Foundation of Alabama Announces $1,000,000 Investment in UAB Breast Cancer Research The Breast Cancer Research Foundation of Alabama (BCRFA) recently presented its largest donation ever of $1,000,000 to the O’Neal Comprehensive Cancer Center at UAB. Since its inception in 1996, the BCRFA has made an annual donation to research with proceeds from all its fund-raising efforts during the prior year. This year’s contribution brings the organization’s cumulative total for research at UAB to more than $8.7 million. “The Breast Cancer Research Foundation of Alabama is critical in making our breast cancer research program one of the best in the country,” said Michael Birrer, MD, PhD, the director of the O’Neal Comprehensive Cancer Center at UAB. “BCRFA is a perfect example of motivating the community to (l to r) Michael Birrer, MD, PhD, the Director of the O’Neal Comprehensive Cancer Center, left, Jill Carter, support new research.” President of the BCRFA Board of Directors, Beth Davis, Executive Director of the BCRFA, and Carol Myers, BCRFA Board of Directors. Community support during 2018 included 20 Alabama fire departments who participated in the Pink Ribbon Project, selling t-shirts during October to raise funds and awareness, along with dozens of other businesses, schools, churches and individuals that used grassroots fundraising to raise money for breast cancer research. “As a breast cancer survivor myself, I am thrilled that we are able to invest $1,000,000 in life-saving breast cancer research this year,” said Jill Carter, BCRFA board president. “Without the support of our sponsors, donors and community partners, this donation would not be possible.” Approximately one-half of the total donation was raised through the BCRFA specialty car tag sales. Available at DMVs across the state, over 12,500 vehicles in Alabama sport the Breast Cancer Research tag. 100 percent of funds received by the BCRFA.

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FEBRUARY 2019 • 21


GRAND ROUNDS

Fobian Honored Aaron Fobian, PhD, assistant professor in the UAB Department of Psychiatry and Behavioral Neurobiology, has been given the prestigious designation of Rising Star by the Association of Psychological SciAaron Fobian, ence. PhD The honor seeks to recognize early career PhD scientists who have conducted groundbreaking research. APS Rising Stars must be nominated by one APS member and one APS fellow. Since the designation is for PhD scientists in the beginning stages of their lines of research, nominees must have received their doctoral degrees within the past five years and have sig-

nificant publications, recognitions or discoveries. “It is an incredible honor to be recognized,’” Fobian said. “I hope my work will continue to assist the physical improvement and psychological wellbeing of children and adolescents.”

Jayme Locke, MD Named Director Jayme Locke, MD has been named director of the UAB Comprehensive Transplant Institute. Locke currently serves as an associate professor in the Division of Transplantation; director of both the Incompatible Kidney Transplant Program and the Transplant Analytics, Informatics and Quality program; vice chair of Outcomes and Health Services Research in the Department of Surgery; and asso-

BBH Primary Care Gardendale Moves to New Location and Adds Providers On February 4th, Brookwood Baptist Health and Brookwood Baptist Health Primary & Specialty Care Network began treating patients in their new, larger Gardendale practice. Sharon Gray, MD and Terry Kinnebrew, MD have been dedicated to caring for patients in Gardendale and surrounding areas since 2004. In 2017, they were joined by Judith Cooley, CRNP, and with the new location, they are joined byWilliam Sides, MD, J.W. Pitts, MD, and Agnes Collins, PA. The larger space is located at 430 Fieldstown Road in Gardendale. In the near future, the new location will feature an onsite pharmacy and specialty care services, including cardiology, orthopedics, urology and general surgery.

Jayme Locke, MD

ciate chief medical officer for Inpatient Quality and Patient Safety at UAB Hospital. “Locke is a nationally recognized leader in transplant surgery and acute outcomes research. She is an abdominal transplant surgeon who specializes in innovative strategies for the transplantation of incompatible organs, disparities in access to and outcomes after solid organ transplantation, and transplantation of people living with HIV,” said Selwyn Vickers, MD, dean of the UAB School of Medicine. “Her research interests include complex statistical analysis and modeling of transplant outcomes and behavioral research focused on health disparities.” Locke earned her bachelor’s degree from Duke University and her medical degree from East Carolina University. She earned a Master of Public Health degree from Johns Hopkins University’s Bloomberg School of Public Health. She completed her residency and her abdominal transplant fellowship at Johns Hopkins Hospital. After concluding her training, she joined UAB’s surgical faculty in 2012. She is a member of the American Society of Transplantation, the American Society of Transplant Surgeons, the Society of University Surgeons, the Southern Surgical Association and more. Additionally, Locke is an associ-

ate editor for Transplantation and the American Journal of Transplantation, and is a member of the Annals of Surgery editorial board. She has been the recipient of numerous awards and honors, with the most recent ones being the Association for Clinical and Translational Science’s Distinguished Investigator Award for Translation into Public Benefit and Policy, the American Transplant Congress Young Investigator Award, Birmingham Business Journal’s Top 40 Under 40 Award, and AL.com’s 2015 Women Who Shape the State. The Comprehensive Transplant Institute recently celebrated its 50th anniversary. It is the site of the nation’s longest-ongoing, single-center paired kidney transplant chain and recently surpassed 10,000 total kidney transplants — one of only three U.S. transplant programs to do so.

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22 • FEBRUARY 2019

Birmingham Medical News


GRAND ROUNDS

Medicare Expansion is a Necessity for Alabama Hospitals Big Economic Benefit for the State

Alabama has an opportunity to generate billions of dollars in economic activity and state savings and provide more than 340,000 Alabamians with health insurance coverage, according to two reports released this week regarding Medicaid expansion. The first report, produced by David Becker, PhD., UAB School of Public Health, updates an earlier report from 2016. The new estimates reveal that 340,000 individuals would be covered under Medicaid expansion, providing Alabama with an economic boost of more than $11 billion over four years. “While Alabama missed the first three years of 100-percent federal funds, the updated estimates show that the impact would be significant as the federal government will still provide $9 for every $1 the state spends on the expanded population,” Becker said. “In addition, when you consider the additional state and local taxes and the predicted state savings, the costs to the state are minimal as compared to the benefits provided.” Becker explained the ripple effect of the influx of federal dollars and increased Medicaid enrollees, noting that the number of health care services and

employees would increase as would the community services required to support the additional growth and the taxes paid by the newly created jobs. Building on the evidence from states that have already expanded their Medicaid programs, Manatt, a national consulting firm, released a report that affirms Becker’s enrollment estimates and adds to it the potential for state savings. “We predict Alabama could free up almost $60 million the first year of expansion, with an increasing amount each year. These dollars could be reinvested to help maintain the state’s health care delivery system,” Deborah Bachrach, a partner with Manatt, said. Alabama is currently one of only 14 states that have not expanded Medicaid, putting it in a precarious position with the upcoming federal cuts to hospitals. Becker highlights the potential harm. “When Congress passed the Affordable Care Act, the assumption was that states would expand Medicaid to help cover the uninsured. So to help offset the costs of expansion, Congress mandated cuts in payments hospitals receive to cover the cost of the uninsured.” “Alabama’s hospitals are scheduled to lose $119 million in federal funding unless Congress takes action,” said Owen Bailey, chairman of the board of the Alabama Hospital Association. “Those are critical dollars for us, as our

hospitals currently spend more than $500 million each year in care for which they receive no reimbursement. In fact, three-fourths of our hospitals are currently operating in the red, and 12 hospitals have closed over the last eight years. For many, the additional cuts won’t be sustainable.” Highlights of the reports (both of which focus on 2020 through 2023): • More than 340,000 individuals are estimated to enroll the first year. • Estimated economic impact of federal spending on Medicaid expansion is $2.7 billion in 2020 up to $2.97 billion in 2023 with overall impact for the four years of $11.4 billion. (Becker report) • Additional taxes generated - $715 million over the four-year period, with $446 million in new state taxes and $269 million in new local taxes. (Becker report) • Estimated state savings (based on increased federal match for existing populations and enrollment in expansion of those currently covered with 100 percent state funds) – range of $59 million in 2020 to $87.6 million in 2023. (Manatt report) Download reports from www.alhealthmatters.com

Forbes Names BCBS of Alabama One of America’s Best Employers for Diversity Forbes named Blue Cross and Blue Shield of Alabama one of America’s 2019 Best Employers for Diversity. Only 500 companies earned this distinction, and Blue Cross scored in the top third. Blue Cross was also one of only two companies in Alabama to earn this recognition. “We are honored to be recognized,” said Tim Vines, CEO of BCBS of Alabama. Recognition was based on Forbes randomly surveying 50,000 employees of companies with 1,000 or more employees, and 100-129 respondents were surveyed about Blue Cross. The evaluation was based on four criteria: 1. Direct Recommendations from Employees 2. Indirect Recommendations from Participants of Other Employers 3. Diversity among Top Executives/ Board Members 4. Diversity Key Performance Indicators This is the second consecutive year Blue Cross has been recognized by Forbes.

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