WNY Physician Buffalo Vol 3 2016 by Western NY Physician: Rochester & Buffalo

Western New York

buffalo and the great lakes

PHYSICIAN the local voice of practice management and the business of medicine

VOLUME 3 / 2016

Advances in Menâ&#x20AC;&#x2122;s Health: High Tech and HIFU

New procedures represent a revolution in prostate cancer diagnosis and treatment

UroLift: A Game-Changer for BPH Patients

Let Your Legacy Live On: Preserving Wealth in Future Generations

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Contents WESTERN NEW YORK PHYSICIAN I VOLUME 3 I 2016

buffalo and the great lakes

Financial Insights Let your Legacy Live On: 14 Preserving Wealth in Future Generations

Lifestyle Empathetic Conversations 24

COVER STORY

05 Advances in Men’s Health: High Tech and HIFU New procedures represent a revolution in prostate cancer diagnosis and treatment

Enter a new era in prostate cancer. Innovations in diagnostics, imaging and robotic tools offer urologists novel, minimally-invasive options for their patients. Now with advanced imaging capability, urologists can map a patient’s unique prostate greatly improving accuracy in diagnosis. And if care progresses to treatment; the recently FDA-approved High-Intensity Focused Ultrasound (HIFU) robotic procedure offers patients vastly improved options with significant preservation of post-treatment function.

Clinical Features 09 UroLift: A Game-Changer for BPH Patients

Providers Still Not Addressing Cybersecurity Risks Poor IT Practices Lead to Large

Penalty

Professional Liability 21 What is My Liability?

Documents to Have (and Your

Patients Should Have) Before Incapacity or Death

26 What’s New in Area Healthcare

21 Recognizing and Managing

Options

New Survey Shows Many

18 Aortic Center Addresses Critical AA Cases

12 Dysphagia: Exploring Treatment

Legal Notes

Side Effects of Immune-Based Cancer Treatments

03 Concussions: Current Concepts

Editorial Outlook

10 5

WNYPHYSICIAN.COM VOLUME 3 I 2016 I 1

from the publisher

Western New York

Visit us Online www.WNYPhysician.com

PHYSICIAN the local voice of

practice management and the business of medicine publisher

Andrea Sperry

Welcome to the latest issue of Western New York Physician where you will find informative stories and articles about and for physicians in western NY. Prostate cancer is the second leading cause of cancer death in American men, just behind lung cancer. About 1 man in 39 will die of prostate cancer. ~American Cancer Society

business development

Stacy Wright creative director

Lisa Mauro writer

Erich Van Dussen

In this issue we were thrilled to get an inside look at cutting-edge technology marking the greatest advancement in prostate cancer diagnosis and treatment since the PSA test. Our thanks to the doctors who invited us and to our corporate sponsors who helped support this issue to reach, educate and inform all physicians throughout the Rochester and Buffalo region. With novel new approaches to diagnose and treat and innovations in implant technology â&#x20AC;&#x201C; options in prostate health care enters a bright new era. Take Part in the Conversation Share your expertise in a relevant way with your medical colleagues. We invite your story suggestions, feedback and article contributions. To discuss timing and submission criteria please email or call me directly. In the meantime, please enjoy the numerous other articles within the issue. As always, we thank each of our Sponsors and supporting Advertisers -- your continued partnership ensures that all physicians in the region benefit from this collaborative sharing of information and provides the WNYP editorial staff with a deep pool of expert resources for future interviews and articles. In good health â&#x20AC;&#x201D;

Andrea Sperry WNYPhysician@gmail.com (585)721-5238

Western New York Physician Magazine would like to thank the following sponsors:

2 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

photography

Lynne Tseng Department of Surgery Rochester Regional Health System medical advisory board

Joseph L. Carbone, DPM John Garneau, MD Johann Piquion, MD, MPH, FACOG James E. Szalados, MD, MBA, Esq. Catherine C. Tan, MD John R. Valvo, MD, FACS contributors

Erich Van Dussen Megan Henry Renee Reynolds, MD James E. Szalados, MD, MBA, Esq. Igor Puzanov, MD, MSCI, FACP Theresa Richard MA, CCC-SLP Michael J. Schoppmann, Esq RPCI Press Roger Walcott, MD Paul Anain, MD Hakeem Shakir, MD contact us

For information on being highlighted in a cover story or special feature, article submission, or advertising in Western New York Physician WNYPhysician@gmail.com Phone: 585.721.5238 reprints

Reproduction in whole or part without written permission is prohibited. To order reprints of articles appearing in the magazine, please contact the Publisher. Although every precaution is taken to ensure the accuracy of published materials, Western New York Physician cannot be held responsible for opinions expressed or facts supplied by its authors. Western New York Physician is published monthly by Insight Media Partners.

clinical feature

CONCUSSION: Current Concepts Renee Reynolds, MD The Center for Disease Control (CDC) estimates that in the Unites States, there are an estimated 3 million sports and recreation related traumatic brain injuries that occur annually1. Although March is acknowledged as Concussion Awareness month, with such staggering statistics and football, soccer and ice hockey seasons well underway, sports related head injury is often a “hot topic” this time of year. Unfortunately, in spite of considerable research into this “hot topic” there remain many unanswered questions. Despite the existence of several consensus statements, even the characterization remains somewhat elusive without a single accepted unifying definition. The American Academy of Neurology (AAN) states that “concussion is recognized as a clinical syndrome of biomechanically induced alteration of brain function, typically affecting memory and orientation, which may involve loss of consciousness2.” The ineffable nature of this condition lends itself to interpretation, controversy, and confusion surrounding the diagnosis of concussion. Furthermore, we have even less science looking at brain recovery, making it ever more challenging for providers and families to make decisions about athletes and their involvement in sports after an injury of such magnitude. Most agree that the management of sports related concussion begins prior to play and encompasses prevention, recognition and proper recovery3. Prevention should ideally come in two forms: preseason evaluation and education. Preseason evaluations comprise full neurologic and balance assessments as well as cognitive evaluations to ensure the athlete is appropriate for play and allow for comparison at the time of a suspected injury. Education is paramount and should include the athletes, coaches, parents, administration and health care providers. There are a variety of formats through which to relay this educational material with no single avenue proven better than the other. The education about concussion needs to focus on proper play technique, equipment, signs and symptoms of concussion, delayed onset of symptoms, and consequences of missing such signs. Recognition of a sports related concussion relies heavily on the proper education previously outlined. The initial step in assessment should always include evaluation for a more severe brain injury or spine injury. Once ruled out, the diagnosis of a sports related concussion is often made utilizing a variety of approaches including symptom review and given the subtle

Dr. Elad Levy, Medical Director Neuroendovascular Services at GVI and Dr. Renee Reynolds, MD Associate Program Director, Neurosurgery Residency Program.

findings at times, more formal sideline evaluations of cognition and neurologic function. On both the sidelines and in the office a standardized assessment tool can be helpful with many sports organizations utilizing the Sideline Concussion Assessment Tools (SCAT) of which SCAT-3 comes with the recommendations most national organizations involved in sports related concussion including the AAN3. This tool encompasses a symptom checklist, a brief cognitive evaluation and a modified balance assessment and allows for the preseason evaluation and sideline comparison discussed in the prevention section. However, it is of utmost importance to recognize the limitations of these assessments. If strong clinical suspicion exists for a sports related concussion based on the mechanism of injury or other features of the athlete’s condition, the discretion of the evaluating personnel should supersede the assessment tools estimation. Once a diagnosis of a sports related concussion has been made the athlete should be removed from play immediately. Unfortunately, there is no specific model to follow regarding the subsequent management. Most agree this should be followed by a treatment course of physical and cognitive rest until symptoms have resolved. Many do within 2 weeks of the event although this varies greatly and is influenced by a variety of features including the severity of the injury, previous history of concussion, and the symptoms3-4. All international organizations agree players should then engage in incremental and

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progressive return to play in a systematic fashion and that prior to return to contact activities there should be a complete recovery of baseline neurologic and cognitive function and balance. While not all concussions can be prevented, following appropriate return to play protocols is key to preventing more severe concussions in the future. This includes “second hit” injuries, when a second concussion injury too soon after the initial injury causes a more severe and often permanent neurologic damage. With such a desperate need for continued education and research into sports related concussion, the trend both locally and nationally, is for students to become more aware of the signs and symptoms of concussions so that they can articulate what they are feeling should they have a possible concussive impact. Within Western New York organizations such as Women and Children’s Hospital of Buffalo through the Kohl’s Cares Campaign and PUCCS (Program For Understanding of Childhood Concussion and Stroke) are helping to promote this locally. These organizations work year round through

health fairs, large youth sporting events such as soccer, hockey and football tournaments and community programs to educate students, parents, coaches and health care professionals that “it’s ok not to be ok!” in hopes of bringing awareness to sports related concussion and to make student athletes more comfortable reporting their symptoms. Additionally, PUCCS is currently working with the Erie County Legislators to launch a new public awareness campaign that is designed to get the word out about the newly passed law that requires coaches of youth impact sports to take a concussion certification course every two years. For more information about sports related concussion, the local organizations involved in community outreach or how to get involved yourself visit www.wnysportshealth.com or http:// puccs.org. 1 http://www.cdc.gov/traumaticbraininjury/data/ 2 https://www.aan.com/concussion 3 Putukian M, MD and J Kutcher MD. Current Concepts in the Treatment of Sports Related Concussions. Neurosurgery 75 (4), Oct 2014 Supplement, S64-S70 4 Tator C, MD, PHD and H Davis. The Postconcussive Syndrome in Sports and Recreation: Clinical Features and Demography in 138 Athletes. Neurosurgery 75 (4), Oct 2014 Supplement, S106-S112.

American HIFU Mobile High Intensity Focused Ultrasound & MRI Biopsy Service American HIFU the leading mobileprovider of Ablathem HIFU delivers the latest prostate treatment technology to western NY urologists and their patients. • Ablatherm HIFU offers your patients noninvasive options for improved treatment • Convenient, streamlined and flexible scheduling and terms • Ability to share capital costs and pool patient data • Provides comprehensive training and support

To learn more: 1 (800) 669-7744 www.americanhifu.com 4 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

cover story

Advances in Men’s Health: High Tech and HIFU

New procedures represent a revolution in prostate cancer diagnosis and treatment By Erich Van Dussen

In the first case outside of greater NYC, Dr. Stefan Thüroff (L) shares guidance and expertise with Dr. Anees Fazili, from the Center for Urology. Dr. Thüroff travels the world serving as preceptor to surgeons advancing skills with this new technology. Brighton Surgical Center in Rochester, NY welcomed this first case to western NY.

Imagine something small but important needs to be located from inside a room. The prize is clearly indicated on a map, but you can’t take the map along to aid you in your search – not that the guide would provide much help anyway, given that there are no lights in the room. For years, urologists haven’t had to imagine this scenario; it’s one they have faced whenever a patient’s prostate specific antigen (PSA) levels indicated the likely presence of cancer, and the need for a biopsy.

PSA testing, introduced in the 1990s, “made a big difference in our ability to help our patients,” says John Valvo, MD, FACS, of the Center for Urology in Rochester. “But it had its limitations. Because it’s just a relative indicator of the presence of prostate cancer, it could only give us an awareness of whether something was wrong – never where within the prostate we should look.” Since the 1980s, the use of transrectal ultrasound to guide a needle biopsy has been considered best practice in the loca-

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Dr. Stefan Thüroff (R) observes Dr. Louis Eichel, an experienced urologist from Center for Urology.

tion of cancer cells whose presence was suggested via PSA test results. Still, the limitations of an ultrasound-guided procedure were plain to see – or rather, not to see. Ultrasound images don’t provide the necessary clarity to make prostate biopsies anything more than … well, a peek into a dark room. “Historically, when we have made a diagnosis of prostate cancer, we have done so somewhat empirically, somewhat physically, and somewhat blindly,” Dr. Valvo says. “It’s the only organ that we’re forced to biopsy blind – of course we can see where the needle is, but without a precise idea of where within the prostate to put the needle, we haven’t given ourselves the best chance of picking up the right cells to biopsy.” The Center for Urology’s Louis Eichel, MD, describes that process more specifically: “Traditionally you would establish 12 quadrants in the prostate, and use the needle to obtain cell samples from each of the quadrants to give you a sense of cancer within the gland. But even a very large tumor could be missed that way – there’s just too much area, and too much variability in the shape and size of tumors that can’t be accounted for by that technology.” “Basically, it was hit or miss,” Dr. Valvo adds. “And many men, despite having multiple biopsies because of their PSA test results, would still had those biopsies come back negative for the presence of cancer.” Enter the fusion-guided 3D biopsy, to shine a bright light on that dimly-lit scenario. Just as the introduction of PSA testing turned the page on a bold new era of prostate examination, the transition to fusion-guided biopsies represents an equally dramatic new chapter in this evolving science. 6 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

Combining 3T MRI and Ultrasound As its name implies, the fusion-guided biopsy depends on the merging of two complementary imaging technologies – 3T MRI and ultrasound – to achieve a result that is far greater than the sum of their parts. First, a patient whose PSA tests indicate the presence of cancer cells will undergo an 3T MRI scan of their prostate. 3T MRIs are far superior to ultrasound in their ability to visualize the presence of prostatic irregularities. “They show up as hot spots,” Dr. Eichel says. Using 3T MRI as an imaging modality in this way has been nothing short of revolutionary, he adds. “It’s really the only imaging technique we have for showing high-grade, potentially lethal prostate cancer – less effective in identifying lower-grade cancers, but those are typically less risky for the patient.” (Patients with clinically insignificant prostate cancers – typically evidenced by a Gleason score of 6 out of 10, indicating a relatively low likelihood of metastasis – may elect to forego treatment, he says.) Unfortunately, the narrow confines of an 3T MRI chamber make a decidedly unsuitable setting for a prostatic needle biopsy. That’s where the fusion process comes in: After the 3T MRI is conducted, proprietary software mates the scan data to a reconstructed ultrasound image of the patient’s anatomy, allowing the specialist to visualize those hot spots, in real time, while the biopsy needle is in the prostate. The procedure still relies on ultrasound, but with an essential navigation assist that provides a new and decidedly more effective benefit in tumor location. That, in turn, drives greater success in testing, diagnosis and eventual treatment.

“Focal prostate cancer HIFU ablation in “low risk/low volume disease” and “focal therapy after failed radiation”– both in “unilateral” disease (in right or left prostatic lobe only)– are the greatest opportunities in modern individual sequential prostate cancer therapy.” “Patients will – if the treatment is affordable (insurance covered) – opt for this noninvasive out-patient therapy, when they understand the medical principle, because this therapy doesn´t burn bridges. For physicians the learning curve is short, structured, controlled and safe.” STEFAN THÜROFF, MD, PHD Stefan Thüroff, MD, PhD, is an urologist at the Clinic of Urology, Hospital in Munich. He is one of the first doctors performing procedures using HIFU, an acclaimed expert on this method and its propagator all over the world.

The Center for Urology utilizes Navigo fusion-guided software, developed by the Israel-based UC-Care Medical Systems. “It’s extraordinary,” Dr. Valvo says of the technology. “It essentially introduces GPS-level imaging to a process that was previously conducted in the dark.” Returning to the analogy of entering that darkened room without a map, “the 3T MRI test allows us to create a 3D hologram of that room, and light it up for you when you walk in,” Dr. Eichel says. “It’ll be glowing, and show you almost exactly where you need to go.” The introduction of this adaptive science has made a huge impact on diagnostic effectiveness within the field, Dr. Eichel says. “Now, instead of wondering whether we’ve hit the area with the needle, we know we’ve hit it. It’s so much more exact, and it dramatically lowers the likelihood of getting a false negative result.” Urologists without access to fusion-guided technology may improvise and perform a “cognitive biopsy,” Dr. Valvo says. “That’s when they can use the 3T MRI image to identify a specific area within the prostate where a hot spot is present. Then they will use ultrasound alone, and just focus their efforts on that section of the prostate in conducting the biopsy.” The difference between that and a fusion biopsy, he says, is in the actual mapping of the gland that is made possible by the overlay of the 3T MRI data with the ultrasound technology. “Both ways are helpful, but there’s really no comparison to performing a true fusion biopsy,” Dr. Valvo says. “And I think the patients are quite pleased because they’re not getting stuck over and over again, like a pin cushion.” Challenges, and Future Potential As with any revolution, the transition to fusion-guided biopsies isn’t without its challenges. For all its clear advantages over biopsies guided by ultrasound alone, at least two complications exist in the practice of this new technique. First and most surmountable is the limited availability of 3

Tesla (3T) MRI scanning, the gold standard for use in this type of prostate test. “It isn’t perfect, but it’s very, very good,” Dr. Eichel says. Not all imaging centers in the greater Rochester region offer 3T MRI technology, but referring physicians can direct a patient to the appropriate office to receive a scan – and with the imaging files in hand, any urologist with access to a fusion biopsy system can use that 3T MRI information to produce the desired results. More challenging, however, is the reluctance among insurance companies to approve the fusion-guided biopsy procedure – at least at first, and at least for now. “Some insurance companies have one requirement before they will pay for it: you have to first go through a negative biopsy showing no disease,” followed by additional PSA testing that still suggests the presence of cancer, Dr. Valvo says. “It’s crazy.” Due to the known vulnerabilities of the standard ultrasoundguided biopsy in catching tumor cells, it’s not uncommon for some cancers to spread for an additional six to 12 months after being detected via PSA testing before they are found using the “blind” ultrasound-only biopsy technique. “Sometimes longer – even two years,” Dr. Eichel says. “It all depends on the frequency of PSA testing, and the good luck of getting the needle in the right spot within the gland.” Dr. Eichel believes fusion-guided biopsies will eventually become more accepted practice in the eyes of payers. “Right now they might only have to pay for one 3T MRI for every five biopsies conducted – it’s a cost-cutting measure,” he says. “If the finances weren’t an issue, we’d do these on everybody, but once the cost of 3T MRI comes down, it just makes sense to make it a regular occurrence to get the 3T MRI first. It will cut down on the number of biopsies needed, and it stands to reason that you could catch a lot of cancers sooner.” Dr. Valvo takes that prediction a step further: “In the near future the imaging capability using 3T MRI will supplant the PSA test altogether,” he says. “It’s too effective not to become the new standard.”

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HIFU for Prostate Cancer Treatment With state-of-the-art technology HIFU (high-intensity focused ultrasound) safely and effectively destroys targeted tissue during an individually customized prostate cancer treatment. HIFU is a revolutionary form of treatment for organ-confined disease allowing treatment of prostate cancer without radiation or surgical incision and with minimal side effects. HIFU is recommended for: • First-line treatment of T1-T2 patients who are not suitable or do not want surgery • Salvage treatment for local recurrence after Radiotherapy or radical prostatectomy • Focal treatment of a well localized/well defined tumor in both first-line and salvage strategy

Always at the forefront of advancing technologies in Urology Drs. John Valvo and Louis Eichel from the Center for Urology are among the first urologists in western NY to offer HIFU Ablathem to patients.

Making Waves with HIFU The use of ultrasound as a diagnostic tool has been given new life thanks to fusion-guided biopsy technology. And for patients for whom that technique delivers a diagnosis of prostate cancer, ultrasound is the foundation of a new leading-edge treatment as well. Of course, High-Intensity Focused Ultrasound (HIFU) isn’t new at all. But its use in the United States is now on the rise, following FDA approval in late 2015 – and decades of welldocumented successes in other countries. HIFU utilizes ultrasound waves that generate heat within isolated areas of the prostate. This focused treatment can ablate targeted regions of the gland as effectively as radiation treatment, but without the side effects associated with radiation therapy. And by avoiding surgery altogether, patients are also able to avoid post-operative repercussions. “The side effects of different forms of prostate cancer treatment weigh heavily on the minds of men who face that diagnosis,” Dr. Eichel says. “After a prostatectomy you have to learn how to hold your urine, and a small percentage of men – in the 5-to-7 percent range – don’t get that ability back. Erectile dysfunction is very common as well, and a very significant portion of men don’t regain that function in their life. Radiation therapy, too, carries significant risk of life-altering side effects.”

HIFU, though still considered new in America, has long provided a compelling option for patients in other countries. “American men heretofore had to go Canada, Mexico or even Europe for HIFU therapy,” says Dr. Valvo. “With reluctance in this country to accept the technology, it grew in other areas of the world. But with FDA approval here, I’m pleased to say it is emerging as a real opportunity for prostate cancer patients.” In its current approved state, HIFU is administered via what is essentially a robotic platform: Surgeons direct the machine to the area of the prostate indicated by the 3T 3T MRI scan data, and the system goes to work – with pre-programmed safety protocols designed to halt the process with split-second precision if an abnormality is detected. “It takes the guesswork out of the equation, and creates a much safer treatment for the patient,” Dr. Eichel says. Through this process, HIFU can be ideally used to ablate half or all of a prostate gland – attacking the cancer while preserving the patient’s post-treatment function to a much greater degree than surgery or other less invasive treatments. “This is a major change in the way we are able to treat medium-grade cancers that have not spread throughout the prostate,” Dr. Valvo says. Meanwhile, the FDA is reviewing an even more advanced use for HIFU technology: focused therapy that targets specific areas within discrete portions of the prostate, to allow absolutely minimal exposure to the heat generated by the ultrasound waves. As with fusion-guided biopsies, insurers are proving slow to endorse HIFU as anything more than a non-covered experimental procedure. “Unfortunately, it can take years before the establishment comes to accept these breakthroughs as a reliable part of our treatment arsenal – and it is certainly expensive without the benefit of insurance coverage,” Dr. Valvo says. “But it is exciting to be able to offer a treatment modality that can provide a true alternative for some patients, and that takes full advantage of modern technology.” Erich Van Dussen is a freelance writer living in Western New York.

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UroLift: A Game-Changer for BPH Patients By Erich Van Dussen For male patients over 50 years, a diagnosis of benign prostatic hyperplasia (BPH) typically follows months or even years of discomfort and urinary challenges – and until recently that diagnosis has been followed, in turn, by a somewhat limited array of treatment options. Pharmaceutical remedies such as alphaPeter Walter, MD, FACS blockers or 5-alpha reductase inhibitors can bring about relief, but not without significant potential side effects; a typical patient, after all, is of an age at which prescriptions can start to pile up and polypharmacy issues can be a legitimate concern. Surgical resection of the prostate is typically the last resort. Minimally invasive procedures like microwave therapy have been sought by patients as a means to avoid the risks of surgery. “The older microwave machines were more effective than the later models, but were often poorly tolerated by patients. I have been less impressed with the outcomes yielded by the newer units,” says Peter Walter, MD, FACS a Jamestown-based urologist affiliated with Western New York Urology Associates. “I was looking for a procedure that would be more effective while still being truly minimally invasive – something that would fill the gap between medications and actual surgery.” Now, a new pathway to BPH relief has emerged as a viable alternative. That technique – UroLift System, developed by the California-based manufacturer NeoTract Inc. – has already become a preferred treatment method among innovative Western New York urologic specialists. “Patients are already lining up” for the UroLift procedure, says John Valvo, MD, FACS, of the Center for Urology in Rochester. “If a man lives long enough, he’s likely to encounter some level of BPH at some point. For the vast majority of those patients, a procedure like this may be very, very effective.” FDA-cleared in September 2013, the UroLift System procedure is performed on an outpatient basis, and can usually be completed in less than an hour. Under direct visualization with a scope, the prostate tissue is compressed and implants

are placed on both sides of the prostate, effectively creating an open channel. In a typical UroLift procedure, each of the lateral lobes receives two such implants. When they have been successfully placed, the urethra is unobstructed – allowing the patient to once again enjoy normal urinary flow. The prostatic lining will re-epithelialize as time passes, ensuring that no foreign body within the prostate will be exposed to the flow of urine. This removes the risk associated with previous solutions involving metal stents: over time, urinary minerals and waste products would react with the exposed foreign material, resulting in eventual encrustation and stone formation – a “cure” that could be worse than the condition it was designed to address.

“The older microwave machines were more effective than the later models, but were often poorly tolerated by patients. I have been less impressed with the outcomes yielded by the newer units” In the unusual event that the typical UroLift procedure doesn’t achieve the desired effects, more implants can be applied to the lobes in a follow-up procedure at a later time. More importantly, more invasive procedures such as prostatic resection remain viable down the road. John Valvo, MD, FACS “It leaves all your other options on the table,” says Louis Eichel, MD, a colleague of Dr. Valvo’s at the Rochester-based Center for Urology. “It doesn’t burn any bridges – for instance, precluding you from a trans-urethral prostate resection at some point down the road. For men with a moderate prostatic enlargement, this technique can be a very attractive approach – giving them relief with very little discomfort or bleeding, and preserving the option to try other procedures eventually if they’re needed.” Dr. Walter agrees, citing a positive benefit-risk ratio: “You can

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still proceed to medical or surgical therapies later. The benefits are excellent and the risks are as close to negligible as possible – no noticeable issues with erectile or ejaculatory dysfunction that many men may be concerned with.” Once a primary care physician determines that a non-pharmaceutical approach may be appropriate for their BPH patient, a flexible cystoscopy is performed by a urologist to determine the specific structure of the patient’s prostate. “No two prostates are identical, and it’s useful to know what their individual anatomy looks like,” Dr. Walter says. The UroLift® System is a minimally invasive approach to treating BPH that lifts and holds the blocked urethra. Clinical data has shown that the UroLift System is safe and effective in relieving LUTS due to BPH without compromising sexual function. The procedure can be done in a hospital or office setting under general or local anesthesia. Patients typically can return home the same day without a catheter. With significant symptom relief outcomes and a fewer side effects, the UroLift System can be a first line treatment for patients who prefer an alternative to medication or major surgery.

For many more men, however, UroLift has the potential to be a game-changer in the non-surgical treatment of BPH. Dr. Walter has performed approximately 130 UroLift System procedures since August 2015. “The overwhelming majority of my patients have been extremely happy with their outcomes,” he says, which include improved flow with less hesitancy and intermittency, less dribbling, as well as reduced urinary frequency and urgency. Although the procedure is relatively new, researchers have published four-year data demonstrating the procedure is durable and effective. It will take additional time to determine just how long this procedure remains effective. Even if it only lasts five years, that’s five years of real relief from a lot of BPH symptoms, without the discomfort or side effects that can be brought about by surgery or medications,” Dr. Walter says. “The expectation is that the benefits will last much longer.” Earlier this year, he was inspired by the success of the technique to travel to NeoTract’s headquarters in Pleasanton, CA, to learn more about UroLift and receive advanced training. While there, he observed the fabrication of the implant cartridges. “The quality control is amazing, and the innovative spirit at the facility is just incredible. This is a terrific innovation to be able to offer my patients.” Erich Van Dussen is a freelance writer living in Western New York.

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How UroLift Works The UroLift System procedure can be performed at a doctor’s office or hospital on a single-appointment, outpatient basis. (Images courtesy of Neotract.) [Art: Fig. 1] An enlarged prostate compresses the urethra, making it difficult for urine to flow.

{Art: Fig. 2] The UroLift delivery device is placed through the obstructed urethra, allowing access to the enlarged prostate.

[Art: Fig. 3] The device compresses the prostatic tissue and delivers small permanent implants to pull and hold the tissue away from the urethra, opening the channel.

[Art: Fig. 4] The UroLift device is removed, allowing normal urine flow to resume through the urethra.

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L E G A L

New Survey Shows Many Providers Still Not Addressing Cybersecurity Risks Question: What practices should every healthcare provider follow to protect against cyberattacks? Answer: Cybercrime continues to make headlines across the country, as cyber criminals hack into healthcare databases. According to a recent survey by the Healthcare Information and Management Systems Society (“HIMSS”), the number one threat is ransomware attacks, where a healthcare database is hacked and its medical records held hostage until a ransom is paid. Ransomware attacks were cited most often (by 69% of respondents) as a significant threat to healthcare IT system security. Hackers are believed to seek patient information for one of two reasons. The most common reason to access patient medical records is to steal personal data to commit standard identity theft, such as gaining access to bank accounts

N O T E S

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and opening credit cards. Another form of identity theft, medical identity theft, is growing in popularity. Medical identity theft occurs when a patient’s identity is stolen and used by others to obtain healthcare in that patient’s name. In the age of electronic medical records, medical identity theft also carries the potential threat to the accuracy of the patient’s electronic clinical records, which could have a serious impact on the patient when he or she seeks care in the future. The survey notes that underfunding of health IT defenses has been a recurring theme in security surveys for years and this year’s HIMSS survey is no exception. About half of survey respondents (55%) cited lack of financial resources as a barrier to mitigating their cybersecurity risks. The study further revealed that a significant minority of security pros still report their systems are not encrypting patient data, a basic defense. Security experts all agree that cyberattacks on medical practices of all sizes will continue to increase in the face of many providers’ failure to prioritize the security of their electronic medical records.

clinical feature

Dysphagia

Exploring Treatment Options Theresa Richard M.A. CCC-SLP

Dysphagia, or difficulty with swallowing, can affect up to 35% of the general population. The aging population is most at risk of developing a swallowing disorder as a result of general weakness, illness, trauma, or disease. Dysphagia occurs when a weakness or incoordination in the laryngeal and pharyngeal muscle systems no longer allow food to be safely transferred from the oral cavity to the esophagus. This system can be disrupted allowing food, liquid, or secretions to fall in to the airway resulting in aspiration. Aspiration pneumonia is the leading cause of hospitalization and death in nursing home residents. Dysphagia can also be responsible for dehydration and malnutrition, which can be found in as many as 50% long-term care residents. Speech-language pathologists play an important role in diagnosing an aging or disordered swallow. A clinical swallow exam is first performed to determine if the patient is at risk for aspiration. Once the aspiration risk is determined, an instrumental assessment should be performed. The two instrumental assessments currently available to visualize the swallow are the modified barium swallow study (MBS) and the fiberoptic endoscopic examination of swallowing (FEES). During an MBS, the patient consumes food that is covered with barium and the swallow is visualized laterally on an x-ray. During a FEES, a flexible fiberoptic trans-nasal endoscope is passed along the floor of the patient’s nasal passage in to the hypopharynx. The pharynx, larynx, and upper esophageal opening are viewed directly from above while various consistencies of food and liquid are administered.The physiologic components and underlying biomechanics are evaluated, assessing evidence of penetration and aspiration. FEES is a well established technique that has revolutionized the field of dysphagia diagnostics. Susan Langmore Ph.D. 12 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

demonstrated the effectiveness of the procedure in 1988. FEES has emerged as a safe and cost effective means to provide inhouse swallowing assessments. It is portable, efficient, and well tolerated by most patients, even those with dementia. For many years, the modified barium swallow study (MBS) was considered the ‘gold standard’ in diagnosing dysphagia. However, evidence-based practice does not support the label of ‘Gold Standard’ for the MBS in comparison to FEES. FEES has demonstrated sensitivity equal to or greater than MBS in determining whether a patient is exhibiting penetration and aspiration. (Langmore, 2006) In fact, another study revealed a false negative rate of 20% in detecting aspiration utilizing MBS, and found a 0% false negative rate when using FEES. (Leder et al, 2002) FEES is administered by a specially trained speech-language pathologist. An MBS requires a radiologist to be present which can drive up costs and uses valuable time in a radiology suite. FEES provides visualizations of pharyngeal secretions and laryngopharyngeal reflux that is not detected with MBS. FEES can be performed while a patient is in bed, can be performed on morbidly obese patients, and patients on vents or with trachs. Compensatory strategies are also trialed during the assessment since the patient is not under radiation and there are no time constraints. Oftentimes, patients are evaluated in acute care and promptly discharged to a skilled nursing facility or even home on a modified diet and/or thickened liquids. Many patients require the modified diet for a brief period of time while recovering from an acute condition, but once the condition has improved these patients are left on the prescribed diet unnecessarily which can lead to a decreased quality of life, dehydration, and malnutrition. The cost of sending these patients back to a hospital for an MBS has increased greatly in the last few years due to rising radiology, barium, and transportation costs leading some physicians to hesitate recommending an instrumental swallowing evaluation. However, making dietary recommendations based on a bedside swallowing exam alone has a 70% error rate when

compared to the patient receiving a FEES. (Aviv, 2002). According to Mann et al. (2000), bedside clinical swallow evaluations have been found to underestimate the frequency of swallowing abnormalities and overestimate the frequency of aspiration. This can lead to both inappropriate and/or medical unnecessary treatment, risking malpractice and third party payer denials. Overly conservative recommendations for thickened and altered textures may lead to further medical complications (i.e. dehydration) and a possible unnecessary cost, and even hospital re-admission. Mobile FEES services are very common in many parts of the country and even in downstate NY. These cost-effective services are now available to all western NY skilled nursing facilities, hospitals, outpatient centers, and even home health care companies.

Bio: Theresa Richard M.A. CCC-SLP, is the owner and president of Mobile Dysphagia Diagnostics Speech-Language Pathology Swallowing Services P.C. She completed both her Bachelors and Masters degrees in Speech-Language Pathology from the University at Buffalo. Mrs. Richard is a member of the American Speech-Language Hearing Associationâ&#x20AC;&#x2122;s Special Interest Group 13 (Swallowing and Swallowing Disorders), the Dysphagia Research Society, the New York State SpeechLanguage Hearing Association, and former President of the Nevada Speech-Language Hearing Association. She has also received the Award for Continuing Education from the American Speech-Language Hearing Association for the past 3 consecutive years. She is an applicant to become a Board Certified Specialist in Swallowing and Swallowing Disorders.

References: Aviv, J. (2002) The bedside swallowing evaluation when endoscopy is an option: What would you choose? Dysphagia; 17(3):219 Langmore SE, Schatz K, Olsen N. (1998) Fiberoptic endoscopic examination of swallowing safety: a new procedure. Dysphagia; 2: 216â&#x20AC;&#x201C;219. Langmore, S.E. (2006). Endoscopic evaluation of oral pharyngeal phases of swallowing. GI Motility online, May, doi:10.1038/gmo28. Leder, S. (2002) Aspiration risk after acute stroke: comparison of clinical examination and fiberoptic endoscopic evaluation of swallowing. Dysphagia; 17(3): 214-8. Mann, G., Hankey, G. J., & Cameron, D. (2000). Swallowing Disorders following Acute Stroke: Prevalence and Diagnostics Accuracy. Cerebrovascular Diseases; 10, 380-386.

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financial insights

Let Your Legacy Live On Preserving Wealth in Future Generations Megan Henry Managing Director, Trust Services, Manning & Napier President, Exeter Trust Company

Many physicians have the enviable burden of owning a significantly large Individual Retirement Account (IRA). They want to have those assets available for the well-being and financial security of their loved ones even after they have passed away. It sounds simple, but anyone living with an IRA knows that IRA rules are anything but – tax deferral status can be compromised if rules aren’t followed, and required minimum distributions (RMDs) require that you remember to take out money each year (after reaching the age of 70 1/2) or suffer massive tax penalties. Standard beneficiary designations fall short of helping your heirs protect their interests from taxes, creditors, or sometimes even themselves. Making sure your IRA assets are properly addressed in your estate tax planning documents is critical. Even if your estate planning attorney is well-versed in how to incorporate your tax-deferred assets in your wealth distribution plan, having IRA and non-IRA assets held in the same family trust can cause unfortunate tax implications. If you want funds available for the lifetime of a loved one (spouse, children, grandchildren, etc.), but also want to control where any remaining funds are allocated after your beneficiary passes, a trust needs to be incorporated into your plan. Using a standard beneficiary designation of naming individuals as “primary” or “contingent” leaves all the decision making to your heirs, not you. 14 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

What options do physicians and individuals with an IRA have so they can provide for their loved ones and create the legacy they desire? A Trusteed IRA allows for more control over the disposition of your IRA in a straightforward way by addressing the IRA with its very own trust. It simplifies what can be a complicated process. A Trusteed IRA is a special trust that provides security during an IRA owner’s lifetime and beyond, and puts individuals in full control of designating inheritance of IRA assets to heirs and how these assets flow beyond the next generation, all while protecting tax-advantages inherent in a traditional IRA. With Manning & Napier’s Trusteed IRA, we act as the trustee to assure continuity of management of your IRA assets. We also ensure annual RMD requirements are met, even without specific direction from the IRA owner each year to help avoid costly IRS penalties for missed RMDs. Unlike a traditional IRA, our Trusteed IRA has a proprietary beneficiary designation planning document, outlining how to properly designate your IRA assets amongst your intended heirs. Through this process, you can customize the outcome for each heir, including how, when, and to what extent they can access the funds while managing tax outcomes. This planning document gives you full control and ability to customize your distribution plan to ensure your legacy lives on. In addition, Manning & Napier can review your proprietary beneficiary designation planning document alongside your current estate tax plan and will work directly with your attorney to review its suitability.

Manning & Napier Advisors, LLC (Manning & Napier) provides investment advisory services to Exeter Trust Company, Trustee of the Manning & Napier Trusteed IRA. To learn more about Manning & Napier’s Trusteed IRA, please visit: go.manning-napier.com/WNYtrusteedIRA

clinical feature

Recognizing and Managing Side Effects of Immune-Based Cancer Treatments Immunotherapies, which direct and manipulate the body’s immune cells to recognize and respond to cancer as a foreign invader, represent a paradigm shift in how we approach killing cancer cells. While these therapies are generally associated with fewer and less toxic side effects, they are not risk-free, and we must remain alert to possible adverse events and manage them promptly with appropriate intervention.

Immune checkpoint inhibitors have shown great promise as cancer therapies. These agents significantly improve clinical outcomes in numerous malignancies, and combination therapy with ipilimumab (Yervoy®) and nivolumab (Opdivo®) has been shown to improve both objective response rate and progression-free survival in patients with melanoma. However, along with this increased efficacy, we have seen an increase in immune-related adverse events, leading to a discontinuation rate of 30 to 40 percent. Interestingly, a majority of these patients experienced a durable response even after they discontinued therapy. And while they are rare, some highgrade, potentially fatal events have been identified as well. The good news? These side effects are not a deal breaker for using these critical new therapies, but it’s essential to know them, monitor for early warning signs and manage them appropriately. Characterizing these toxicities and grading them accurately is a priority for the practicing oncologist, as more patients with many types of malignancies will be treated with these therapies. Most of the adverse events are low-grade and include skin rashes and diarrhea. However, some cases involve inflammation of the lungs, bowel, pancreas or liver, potentially leading to pneumonitis, colitis, pancreatitis, diabetes and liver damage. Endocrine effects such as irregular levels of thyroid, adrenal and/or pituitary hormones have been observed. These events are generally completely reversible in over 90 percent of patients through treatment with high-dose glucocorticoids. Among these patients, up to half will require hormone replacement for life despite early steroid therapy. Rarely, severe and potentially fatal side effects can occur, including immunemediated myocarditis. For patients on combination immunotherapy with ipilimumab/ nivolumab, I advise baseline and weekly troponin levels during weeks 1-12, and careful monitoring throughout active treatment. Proper monitoring, detection and therapy are a subject of active research at Roswell Park and other experienced immuno-oncology cancer centers. Prepare a pathway to treatment Clinicians must educate their patients and provide written instructions with a list of warning signs and what actions to take in the event that they experience side effects between clinic visits. We must remember that these therapies are new. Per-

Igor Puzanov, MD, MSCI, FACP Director, Early Phase Clinical Trials Program; Chief of Melanoma Section; Co-Leader, CCSG Experimental Therapeutics Program; and Professor of Oncology in the Department of Medicine, Roswell Park Cancer Institute

sonal communication between oncologists and primary care physicians, emergency care providers, hospitalists and other frontline medical professionals is critical for appropriate care and evaluation of the patients and optimal treatment selection. Continuing treatment For 60 percent of patients on ipilimumab/nivolumab therapy, immune-related events can be properly treated with steroids, and the immune therapy subsequently restarted. However, it is encouraging to see that a majority of patients for whom immunotherapy had to be stopped continued to respond once off therapy. These data and the analysis showing that use of steroids did not lower response rates or duration of response are reassuring. Putting it into perspective Cancer therapies, whether chemotherapy, genetic-mutation-targeted therapy or immunotherapy, have side effects. Adverse events with chemotherapy and radiotherapy are well documented, and unfortunately common. Targeted therapies — which by their mechanism of action spare the majority of, but not all, healthy cells — are associated with adverse events in 25 percent of patients, including cardiac-related side effects that are well described with many of them. (Anti-VEGF inhibitors are a prime example, with up to 10 percent of patients experiencing cardiac-related side effects.) The observed adverse events that have been associated with immunotherapy, especially immunotherapy combinations, have to be properly assessed against their clearly improved efficacy in patients with otherwise dismal prognosis from stage IV cancers. As we gain more experience with these drugs, as more treatments become standard of care, and as we analyze the data to determine guidelines for predicting and ameliorating adverse events, the benefits of immunotherapies will continue to grow. Igor Puzanov, MD, MSCI, FACP, Professor of Oncology, Director of the Early Phase Clinical Trials Program and Section Chief of Melanoma at Roswell Park Cancer Institute, spearheads the development of clinical trials for novel cancer therapies, with an emphasis on immunotherapy and targeted agents. His work was instrumental in the development of vemurafenib, vemurafenib+cobimetinib, pembrolizumab and talimogene laherparepvec, the first human oncolytic virus therapy for patients with melanoma, as well as several FDA approvals of breakthrough anti-cancer drugs and combination therapies.

WNYPHYSICIAN.COM VOLUME 3 I 2016 I 15

Our compassionate team, growing medical campus, and innovative breakthroughs. Your better health, medical miracles, and reinvigorated community. At ECMC, we’re proud to grow, care for more patients than ever, and reinvest our success back into Western New York—and grateful to say it’s because of your choosing us as your community hospital. ecmc.edu

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Poor IT Practices Lead to Large Penalty Question: Why was the University of Mississippi Medical Center fined $2.75 million when no patient information was proved to have been accessed? Answer: The University of Mississippi Medical Center paid a $2.75 million penalty to the Office for Civil Rights (“OCR”) as part of an agreement to resolve security problems found after the 2013 disappearance of a laptop computer that contained health information for as many as 10,000 people. An investigation by the medical center revealed that a visitor to the intensive care unit probably stole the laptop after asking to borrow it. OCR concluded that because the laptop could access the medical center’s wireless network, whoever took it could obtain private health information after merely entering a generic user name and password. The medical center is adamant that there is no evidence that health information was accessed or disclosed and officials thought they had taken appropriate steps to publicize the loss as per HIPAA requirements. However, the medical center did not attempt to notify people individually, claiming that they did not have enough information to try to notify people individually. The federal agency disagreed, saying the medical center should have tried to notify individuals. The OCR was also highly critical of the medical center for not doing enough to secure records and allowing ICU workers to use the laptop without individual user names. OCR noted that the medical center had been aware of some weaknesses as early as 2005. Jocelyn Samuels, director of the OCR, said in a statement that the “OCR remains particularly concerned with unaddressed risks that may lead to impermissible access.” A 14 page agreement between the agency and the medical center also lays out a series of other reforms,

including requirements that the medical center designate a person to monitor compliance, draw up a risk management plan across the entire 10,000 employee hospital system, and update its information security policies and its procedures for notifying people about breaches. The medical center also must assign employees individual user names and report to the OCR for three years under the agreement.

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clinical feature

Aortic Center Addresses Critical AA Cases

he aorta is the largest artery in the body, delivering oxygen rich blood to the entire body, including the chest, abdominal organs and extremities. The aorta is the most common site for an aneurysm to develop. An aortic aneurysm (AA) occurs when the wall of the aorta progressively weakens and begins to bulge. As the diameter of the aorta wall continues to enlarge, the risk for rupture increases.

Aortic aneurysms work in two ways: • The force of blood pumping can split the layers of the artery wall, allowing blood to leak in between them. This process is called a dissection. • The aneurysm can burst completely, causing bleeding inside the body. This is called a rupture. Aortic aneurysms were the primary cause of 9,863 deaths in 2014 and a contributing cause in more than 17,215 deaths in the United States in 2009.1,2 About two-thirds of people who have an aortic dissection are male.3 Most patients with an aneurysm will experience no symptoms. Symptoms that do present may be related to the location, size and growth rate of the aneurysm. Family history is an important indicator of AA risk. There is a 15% greater risk of developing an AA if a patient’s parent or sibling has been diagnosed with AA. Other risk factors for aortic aneurysm include: • High blood pressure • High cholesterol • Atherosclerosis • Tobacco use Some inherited connective tissue disorders, such as Marfan syndrome and Ehlers-Danlos syndrome, can also increase patients’ risk for aortic aneurysm. Unhealthy behaviors increase the risk for AA, especially for 18 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

people who have one of the diseases listed above. Tobacco use is the most important behavior related to aortic aneurysm. People who have a history of smoking are 3 to 5 times more likely to develop an abdominal aortic aneurysm.4 The Aortic Center at Catholic Health’s Sisters of Charity Hospital is at the forefront of AA diagnosis and treatment. Physicians who suspect a patient has an aortic condition can initiate care at the Aortic Center with a single call. The medical staff at the Aortic Center is committed to providing patients with an appointment within one week of referral. Physicians at the Aortic Center are available for emergencies on a 24-hour basis, seven days a week. Early screening is vital for diagnosis. For information on AA screenings, call 716-837-2400. Patients referred to the Aortic Center will be treated by aortic experts who collaborate to provide the most effective treatment for all forms of AA including: • Thoracic Aortic Aneurysm • Aortic Dissection • Aortic Occlusive Disease Left untreated, aortic aneurysms can continue growing and rupture, leading to massive internal bleeding and death. Only about 20 to 30 percent of patients with an aortic rupture will survive. This is why elective aneurysm repair is recommended for aneurysms above a certain size. Most aortic aneurysm repairs can be performed with minimally invasive endovascular technology. This involves relining the aneurysm using a synthetic stent graft to strengthen the weakened segment of the aorta. Sisters of Charity Hospital: • Is a leading referral center, treating patients with the most complex conditions • Provides a full array of advanced medical and surgical treatment options

• Is at the forefront of the latest research to improve aortic diagnosis and treatment • Partners with local primary care physicians and area hospitals to ensure timely transfers and safe transitions of care From the first phone call throughout the entire duration of care, our clinical staff works side by side with patients to ensure that they have the support and resources needed for a full recovery. 1. Centers for Disease Control and Prevention. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015. Data are from the Multiple Cause of Death Files, 19992013, as compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. http://wonder.cdc.gov/ucd-icd10.html. Accessed on Feb 3, 2015. 2. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245. 3. Ramanath VS, Oh JK, Sundt TM, Eagle KA. Acute aortic syndromes and thoracic aortic aneurysm. Mayo Clin Proc. 2009;84(5):465–81. 4. Fleming C, Whitlock EP, Bell TL, Lederle FA. Screening for abdominal aortic aneurysm: a bestevidence systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2005;142:203–11.

Sisters Hospital Offers Breakthrough Carotid Artery Disease Treatment For many patients, carotid endarterectomy is a common and a successful treatment for carotid artery disease (CAD), a leading cause of stroke. For some high-risk patients, however, traditional endarterectomy is not a viable option. Sisters of Charity Hospital is one of just 30 hospitals across the U.S. offering a revolutionary new procedure called TransCarotid Artery Revascularization (TCAR). TCAR offers high-risk patients with a less invasive, more effective treatment option that significantly reduces the risk of stroke. During TCAR, blood flow is temporarily re-directed away from the brain, reducing the risk of dislodged plaque reaching the brain. Once the stent is in place, the blood is filtered through a special system outside the body before normal blood flow is restored. Paul Anain, MD and Roger Walcott, MD, vascular surgeons at Catholic Health’s Sisters of Charity Hospital, have successfully performed this new procedure on a number of patients. “While traditional carotid endarterectomy has been the gold standard for treating carotid artery disease, it is not always a viable option for certain patients,” said Dr. Anain. “The TCAR procedure significantly reduces the risk of stroke in high-risk patients.” “We haven’t seen advancement as significant as this in the field of vascular surgery in quite some time, and we are excited by what this means for patients with CAD who were not candidates for traditional stenting procedures,” added Dr. Walcott. “We’re now able to offer all of our patients the same opportunity for a

Roger Walcott, MD and Paul Anain, MD are vascular surgeons and co-directors of the Aortic Center at Sisters of Charity Hospital.

successful outcome, with almost zero risk of stroke.”

WNYPHYSICIAN.COM VOLUME 3 I 2016 I 19

Vascularcare care for for what Vascular what matters mattersmost. most. Sisters Hospital continues to set the standard in vascular care, bringing TransCarotid Artery

Sisters Hospital continues to set the standard in vascular care, bringing TransCarotid Artery Revascularization (TCAR) to WNY. Sisters, along with vascular surgeons Dr. Paul Anain and

Revascularization (TCAR) to WNY. Sisters, along with vascular surgeons Dr. Paul Anain and Dr. Roger Walcott, is the only hospital in Buffalo and one of just 30 across the country who are

Dr. in Roger Walcott, is the only hospital in Buffalo and one of just 30 across the country who are the final phase of a revolutionary ROADSTAR 2 transcarotid stenting clinical trial. TCAR is in the final phase a revolutionary ROADSTAR 2 transcarotid stenting clinical trial. TCAR is changing the wayofdoctors treat carotid artery disease by significantly reducing the risk of stroke changing the way doctors treat not carotid artery disease by significantly the alternative risk of stroke in high-risk patients who were candidates for traditional procedures.reducing An effective in high-risk patients who were not candidates forthe traditional procedures. effectiveoutcome alternative to conventional treatment methods, TCAR offers same opportunity for aAn successful and giving patients and doctors greater flexibility in treatment of complex conditions. to conventional treatment methods, TCAR offers the same opportunity forvascular a successful outcome

and giving patients and doctors greater flexibility in treatment of complex vascular conditions.

To learn more about advanced vascular care at Catholic Health, visit chsbuffalo.org/vascular.

professional liability

What is My Liability? Documents to Have (and Your Patients Should Have) Before Incapacity or Death

Issue

James E. Szalados, MD, MBA, Esq.

As physicians and providers, we regularly counsel our patients and our loved ones regarding their health needs and even their emotional needs. Rarely however, do we consider counselling regarding the basic issues of end-of-life planning that they will need to have in place before they become critically ill or incapacitated. In a very real sense, patients frequently do not grasp their mortality; as physicians, we have an implicit fiduciary duty to counsel regarding end-of-life care planning. There are crucial documents which need to be in place before a patient loses the capacity to make decisions on their own behalf, and, family and caregivers need to be aware not only of the existence of these documents, but also of their location. I recommend the creation of an organized Dossier which family and/or caregivers can easily access in the event of an emergency:

1. Last Will and Testament/ Trusts The original Will is perhaps the most essential document to have on file. When a person dies without a Will, they die intestate, and therefore have retrospectively lost control over how their assets will be distributed. When there is no will to name an executor, state law provides a list of people who, in order, are eligible to serve in the role. Generally, only spouses, registered domestic partners, and blood relatives inherit under intestate succession laws. The process of estate settlement is subject to probate, a process whereby property is appraised, debts are settled, and remaining assets are distributed. Receipt of probate is the first step in the legal process of administering the estate of a deceased. The importance of the original Will lies in its authenticity and finality; when only a copy is available, the will can be subject to a contest, or challenge, thereby incurring legal cost and time delays. Probate applies to each state in which one owns property. A Letter of Instruction can supplement a Will, and, although it is not legally binding, such a letter can provide supplemental instructions such as the names of attorneys, financial advisors, and attorneys. Some people may also choose to establish a Revocable Living Trust in addition to

a Will since assets with named beneficiaries pass directly to the beneficiaries without probate. During the life of the Trust, income earned by the Trust is distributed to the grantor, and upon the death of the grantor, the Trust in its entirety is transferred to the beneficiaries. A Revocable Trust can be altered at any point during oneâ&#x20AC;&#x2122;s lifetime where the grantor also serves as trustee on the behalf of designated beneficiaries.

2. Durable Power of Attorney

A Power of Attorney (POA) is a document which confers decisionmaking power upon others. One can authorize an agent to perform tasks such as the signing of checks and tax returns, to enter into contract, to buy or sell real estate, or to deposit or withdraw funds, or any other similar functions one might otherwise do for oneself. Since the POA document is tailored for specific purpose(s), the agent cannot act outside the scope which is limited or designated in the document. The powers conferred by a POA document terminate either when its purpose has been fulfilled or when the principal is incapacitated or upon his/her death. Therefore, a POA remains effective only while the principal also retains decision-making capacity. In order for the POA to survive a loss of capacity, the POA must be very specifically labelled as a Durable Power of Attorney (DPOA). Such a document may be limited or unlimited in scope, for example, a Durable Power of Attorney for Finance or Healthcare. Without a valid DPOA, if one becomes incapacitated or incompetent, family and/or caregivers cannot complete important financial transactions, use accounts to pay bills or even participate in Medicaid planning. In the absence of a DPOA, family or caregivers would need to address the courts and become a court-appointed guardian on the behalf of the patient. With a DPOA, the agency relationship remains effective in the event of incapacity, which therefore makes a DPOA an important estate planning tool. The powers conferred via DPOA also terminate upon the death of the principal, at which time estate administration begins.

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3. Healthcare Proxy or Durable Power of Attorney for Healthcare A Healthcare Proxy or a Durable Power of Attorney for Healthcare names and confers, upon one or more people, decision-making power regarding healthcare decisions after one loses the capacity to do so. Unless stated otherwise within the proxy, a health care agent can make all decisions that the patient could make while competent. The capacity to make health care decisions is defined in NY Proxy Law as “the ability to understand and appreciate the nature and consequences of health care decisions, including the benefits and risks of and alternatives to any proposed health care, and to reach an informed decision.” Proxy documents are essentially meaningless in the absence of prior careful discussions which explore one’s values and wishes in the event of a potentially catastrophic illness. Far too often, health proxies are completely unprepared to make healthcare decisions because they (a) are unable to understand the implications of the injury or disease process, or (b) have not explored the patient’s real values, fears, and outlook beforehand. It is important also to realize that under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 healthcare providers are legally limited to limiting disclosure of information regarding health of the incapacitated patient to the proxy and/or his/her designees. In the event that there is no named healthcare proxy providers will seek out the statutorily empowered next of kin to assume the role of proxy – that person may or may not be the one a patient would have chosen. A specific HIPAAcompliant authorization for release of medical information can be a valuable supplement to a Healthcare Proxy in the event that the proxy desires to view or obtain copies of the medical record either during phases of care or after a patient’s death. Most states have enacted healthcare surrogacy statutes; in New York Health Care the Proxy Law can be found under Article 29–C of the New York Public Health Law. A crucial document to supplement the Proxy is a Living Will.

4. Living Will A Living Will, also referred to as a ‘Directive to Physicians’ or ‘Advance Directive’ is a document through which one may specify wishes for medical care, including heroic or end-of-life, in the event one becomes incapacitated and therefore unable to communicate. Authorities granted by a Living Will end when one dies, with the exception that some Living Wills or Durable Powers of Attorney for Healthcare confer the power to make decisions about organ donation or autopsy. The importance of a carefully crafted and reasonably comprehensive Living Will cannot be over-emphasized. All too frequently, the utility of a Living Will is undermined by boilerplate attorney-speak which seems logical at first but has little applicability within the complexity of the clinical arena, and may even be frustrating to healthcare providers to try and interpret. Phrases such as ‘if there is no reasonable hope for meaningful 22 I VOLUME 3 I 2016 WNYPHYSICIAN.COM

recovery’ are extremely difficult to apply and essentially do little more than confer decision-making power on the healthcare team of the moment. Far more helpful, are milestones addressing clinical progression or deterioration, in the event of trauma, lifethreatening acute illness, or neurologic incapacitation.

5. Medical Orders for Life-Sustaining Treatment (MOLST) Forms The MOLST form (NY DOH-5003) represents a concrete, witnessed, documentation of one’s treatment preferences concerning life-sustaining treatment. Under NY State law, the MOLST form is the only authorized form for documenting both hospital and nonhospital DNR and DNI orders. One benefit of the MOLST is that it can relieve the proxy of the emotional burdens of decision-making; however limitations of the MOLST are (a) it can be reversed by the proxy of the proxy does not believe that the patient would have wanted the MOLST to apply within that specific circumstance and (b) in the absence of an available proxy, the MOLST is binding and does not allow healthcare providers to exercise discretion in the event of a potentially reversible condition. Patients with severe chronic diseases such as incurable cancers or who have conditions which pose a longstanding, constant and imminent threat to life are among those with whom Primary Care Providers should consider MOLST form documentation.

6. Other Elements of an Estate Dossier Other elements of an estate Dossier will include, but are not limited to: marriage or divorce certificates, documentation of past medical history and active medication lists, property deeds and associated mortgage or loan documents, financial certificates and bank/brokerage account information, partnership or corporate operating agreements, recent tax returns, life and other insurance policies, retirement account and annuity information and contracts, lists of bank accounts, applicable account user names

and passwords, and lists of any safe-deposit boxes.

In conclusion, careful organization and advance planning are crucial to the successful continuity of one’s estate, in a way congruent to one’s personal wishes. There is no substitute to carefully preparing, reviewing, and updating these documents, while one still has the capacity to do so. Optimally, these documents will be designed and written with careful input from one’s physician, and, with the help of an experienced healthcare attorney who truly understands the nuances, complexities, and uncertainties or clinical medicine. We owe it not only to ourselves, but also to our families, friends, and our patients, to help plan for the inevitable. Dr. Szalados is a licensed physician engaged in the practice of anesthesiology, critical care, and neurocritical care; and is a Rochester-based attorney admitted to the practice of Law in New York who concentrates his legal practice in the area of Health Law.

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An Introduction to Next-Generation Sequencing

Indications for Kyphoplasty and Vertebroplasty

An In-Depth Discussion of Multiple Myeloma

Evaluating Back and Neck Pain in a Cancer Patient

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