< Previous8 MD-UPDATE Tort reform has been a hot-button issue in Kentucky for many years. The phrase “tort reform” refers generally to changes in the legal system aimed at reducing the number of friv- olous lawsuits and outrageous jury awards. A significant proportion of tort reform focuses on medical litigation. To stem the flow and soften the blow of medical malpractice claims, several states now limit the amount of money plaintiffs can be awarded in medical malpractice lawsuits. Other states provide certain financial protec- tions for physicians and entities that pay into a patient compensation fund. Yet other states place restrictions on how a successful plaintiff may receive payment of her award (e.g., over time versus in a lump sum). Kentucky lawmakers have proposed tort reform measures time and time again. However, medical malpractice tort reform has not been passed until recently. In 2017, Kentucky enact- ed the Medical Review Panel Act, establishing three-person panels to evaluate the merits of proposed complaints before suit could be filed. The “MRP Act” went into effect in June 2017; it was ruled unconstitutional in November 2018 and is no longer the law. In 2019, the Kentucky Legislature tried its hand at tort reform again, this time by enacting a “Certificate of Merit” law. Kentucky House Bill 429, entitled “AN ACT relating to medical malpractice,” was sponsored by Representatives Chad McCoy, R-Bardstown (a plaintiff’s attorney) and David Osborne, R-Prospect (a realtor). When advocating for the bill, Rep. McCoy claimed to have the support of the Kentucky Chamber of Commerce, the nurs- ing-home industry, and the Plaintiffs’ bar. HB 429 passed 69-24 in the House and 37-0 in the Senate. The Act was signed by Governor Bevin in March 2019 and went into effect on June 27, 2019. It is now codified at Kentucky Revised Statute §411.167, which is entitled “Certificate of merit for medical malpractice actions.” Unlike its predecessor, Kentucky Tort Reform Update: The Certificate of Merit Act BY STEPHANiE WURDOCK From health care transactions and compliance to litigation defense, Sturgill Turner’s health care team is committed to providing comprehensive legal services to health care providers, hospitals and managed care organizations. Lexington STURGILLTURNER.LAW WE’VE DONE THIS BEFORE LEGALISSUE #124 9 the Certificate of Merit Act has not been legally challenged. The Certificate of Merit Act applies to all lawsuits brought by a patient against a licensed surgeon, dentist, physician, hospital, or long- term-care facility for negligence. It mandates that a patient commencing such an action file a “certificate of merit” with the complaint. The Act defines a certificate of merit as an affidavit or declaration stating that: The claimant has reviewed the facts of the case and has consulted with at least one (1) expert ... who is qualified to give expert testimony as to the standard of care or negligence and who the claimant or his or her counsel reasonably believes is knowledgeable in the relevant issues involved in the particular action, and has concluded on the basis of review and consultation that there is reasonable basis to commence the action... In other words, the patient-plaintiff must provide a sworn statement attesting that she (or her attorney) has consulted with at least one expert qualified to render testimony about the medical issues involved in the case and that expert believes there is a reasonable basis to sue for negligence. For example, if a patient wants to sue her orthopedic surgeon for medical mal- practice arising from hip replacement surgery, the patient must certify that she has had the facts of the case reviewed by a qualified medi- cal expert (presumably an orthopedic surgeon) who found a deviation from the standard of care and plausible medical causation. The Act is designed to ensure that medical malpractice plaintiffs can only bring a lawsuit when there is medical expert testimony to support the proposed claim of negligence. Proponents of the Act believe it will prevent non-meritorious medical malpractice lawsuits from being filed. However, the Act is probably not the panacea Kentucky’s healthcare com- munity has been hoping for. First, the practice of consulting with an expert before filing suit has been around for decades and is the general practice of most (if not all) medical malpractice plaintiff’s attorneys. Medical malpractice claims are time-consuming and expensive to litigate. For their own self-preservation, plaintiffs’ attor- neys must thoroughly vet such claims before accepting them. Next, in most cases, a plaintiff is not required to disclose the identity of her consult- ing expert or the so-called expert’s education, training, experience, certifications, or other qualifications. The Certificate of Merit is signed by the plaintiff or her attorney, not the consulting expert. There is no way to ensure a plaintiff’s consulting “expert” is really an expert at all or that the expert truly performed a competent review of the case prior to filing. Finally, the language of the Act suggests that only one Certificate of Merit is required per lawsuit even if more than one defendant is named in the original Complaint or is brought into the lawsuit at a later date. This presents an issue where providers of different specialties are sued together or at different times. Using the previous example, the plain- tiff could file her lawsuit after having the case reviewed by an orthopedic surgeon. Then, months later, the plaintiff could potentially add the radiologist and infectious disease phy- sician as additional defendants without first having those claims reviewed by an expert. Such an outcome is directly contrary to the Act’s intended purpose. The Certificate of Merit Act is certainly a step in the right direction. It will almost cer- tainly preclude patients from litigating med- ical malpractice claims pro se (i.e., without the assistance of counsel), and it may prevent cases involving questionable negligence from being filed. However, in reality, the Act is unlikely to significantly decrease the number of medical malpractice cases filed in Kentucky, and it does nothing to address the “runaway verdicts” awarded by some Kentucky juries. The full text and voting history of Kentucky’s new Certificate of Merit Act can be located at apps.legislature.ky.gov/record/19rs/hb429.html. It should be noted that there are some instances in which a Certificate of Merit is not required; however, those are the exception to the rule and are not discussed here. Ms. Wurdock is a healthcare attorney who works closely with providers, insurers, and risk managers to defend claims of medical malpractice, wrongful death, nursing home negligence, and violations of resident’s rights. She works at Sturgill, Turner, Barker & Moloney, PLLC in Lexington. Her biography and contact information are available at www.SturgillTurner.com. This article does not, nor is it intended to, constitute legal advice. deandortonhealthcaresolutions.com Empowering physicians to focus solely on the demands of their clinical practice 859.255.2341 • Practice Management and Advisory Services • Medical Billing and Credentialing • Human Resources • Technology • Accounting and Financial Outsourcing • Revenue Cycle Management • Compliance and Risk Management LEGAL10 MD-UPDATE “We spend a lot of money on healthcare and health insurance. The problem is, we’re not spending enough on prevention.” — Whitney Jones, MD Dr. Jones Speaks: “Going on Offense against Cancer” Whitney Jones, MD, embraces preventative measures to beat colon cancer before it starts Cover StoryISSUE #124 11 By JIM KeLSey LOUISVILLE In the movie “Karate Kid,” there’s a scene where Mr. Miyagi asks the title char- acter if he’s training to fight. In his light bulb moment, the student responds that he trains, “So I won’t have to fight.” Make no mistake, Whitney Jones, MD, knows how to treat cancer. He’s trained for it and has years of experience in it. But it’s a fight he would prefer doesn’t take place. “We’re going on offense against cancer,” says Jones, a gastroenterologist at Gastroenterology Health Partners (GHP) in Louisville. “We are working on becoming the number one state and the first in the nation to develop programs where we can use genetic testing. We spend a lot of money on healthcare and health insurance. The problem is, we’re not spending enough on prevention. The cost of cancer treatments totally overwhelms the cost of prevention.” That has been the central message and purpose of the Kentucky Colon Cancer Prevention Project, which Jones helped found in 2004. The project’s work includes educa- tion, advocacy, survivor support, and health system change. “It put the work of the state in front of the legislature,” Jones says, noting that a diverse group of leaders from across the state formed the project’s advisory committee. “It added a mix of healthcare, politics, and business that was catalytic.” The project has received state funding as well as additional funding from the Kentucky Cancer Foundation, which Jones also helped found in 2012. “We have helped pay for a lot of uninsured people to get colorectal cancer screening,” Jones says. The impact of the Colon Cancer Prevention Project is reflected in the state’s improvement versus the rest of the country. Jones notes that Kentucky ranked 49 th out of 50 in the nation in colon cancer prevention statistics when the project was launched. The state also had the highest rates of incidence and mortality in the nation. Earlier this year, Kentucky ranked 17 th best in the nation in the same colon cancer related categories and earned an American Cancer Society Achievement Award for the most improved state in the nation for colorec- tal screening over the past 15 years. “When we started our work at the Colon Cancer Prevention Project, there was a huge gap between what could be done and what we were doing,” Jones says. “It’s been a broad coa- lition, including many of our state leaders and city officials. I think it’s proven that Kentucky can address its own problems, we can develop solutions, we can implement them locally, and we can save lives and save money.” A History of Community Involvement Despite his obvious passion for spreading awareness and influencing policy and leg- islation today, that hasn’t always been part of his medical career. A native of Louisville, Jones attended the University of Louisville for undergraduate and medical school. He then completed his residency in internal medicine along with a gastroenterology fellowship at the University of Texas Southwestern Medical School in Dallas. He later completed an advanced fellowship in therapeutic biliary endoscopy at the University of Toronto. He returned to Louisville, where he worked at University Hospital until 1999. In 2000, he was part of a team that formed Midwest Gastroenterology Associates, where he remained until 2017, when he formed Gastroenterology and Endoscopy Associates, which then joined Gastroenterology Health Partners. Formed in 2012, Gastroenterology Health Partners is the largest private gastro- enterology physician practice in the region with multiple locations throughout Louisville, Lexington, and southern Indiana. “It’s a trend across the country where physi- cian practices are either getting bigger or they are getting bought up, with very few small independent practice models still around,” says Jones, who works with Ashok Kapur, MD, and Laszlo Makk, MD, at Gastroenterology Health Partners’ Gastroenterology and Endoscopy Associates locations. Gastroenterology Health Partners has led the region in the establishment of a large, independent, GI-subspecialty private prac- tice, says Cindy Mattingly, the practice CEO. “Our structure is our advantage. We are able to scale our resources to include a full-scope of GI-related services, which allows us to deliver expert care at the greatest value to our patients,” says Mattingly. GHP performs in-house testing and has refined the care-coordination loop with patients and referring providers at the center. GI-related testing and results are returned rapidly and care decisions are immediately addressed as a result. “Our strategic mission is rooted in quality, cost, and access, which sets our focus on the wellness of our patients to ensure they have access to the care they need, when they need it, and at the In addition to his practice at Gastroenterology Health Partners, Jones is actively involved in the Colon Cancer Prevention Project and helped found the Kentucky Cancer Foundation. PHotoS By ALeXANDrA roGerS Cover Story12 MD-UPDATE lowest cost. We constantly seek new ways to deliver on that core mission,” says Mattingly. “That’s how we are able to support superior quality outcomes.” A Visionary for Prevention In addition to his work with colon cancer and prevention, one of Jones’ primary areas of focus is Barrett’s esophagus and early detec- tion of esophageal cancer. Jones participated in research to prevent esophageal cancer as early as 1999 when he was involved in clinical research studies that proved you could treat early cancer and high-grade dysplasia before it became cancer. “One of my favorite things to do is to be able to allow people to eat,” Jones says. “Preventing esophageal cancer is amazing. Since 1999, I’ve only had one person under a surveillance program with me develop esophageal cancer.” That introduction into the power of aware- ness, early detection, and prevention certainly played a role in Jones’ active participation in prevention and early detection programs today. While health issues have limited his abilities to perform endoscopic ultrasound and endoscopic retrograde cholangiopancrea- tography in recent years, he has turned much of his attention to preventing cancers from ever developing. “There are very common factors across all of the GI cancers,” Jones says, noting that smoking, obesity, and poor diet are all behaviors that increase the risk of cancer. “But the single greatest behavioral lifestyle issue with cancer is not being aware of screening, not being aware of your family risk, and not recognizing the signs or symptoms of colon cancer. Those are also all behavioral factors.” Understanding family history can lead to prevention by tipping primary care doctors to high risk patients who could benefit from early screening or genetic testing. Genetics: The Future of Screening “Genetic testing allows us to really hone in on any genetic abnormality and then subject that person and others who are affected in their family to more intense screening, more frequent screening, earlier screening, even risk-reduction surgery,” Jones says. “You can go from having an 80 or 90 percent chance of dying from cancer to living a full life, cancer free, when you identify these people. Instead of waiting until you have cancer to find out you have a bad gene that you got from your dad who died from cancer, we can use your dad’s rough moment to help prevent your cancer from ever happening.” Jones expects genetic testing to become more commonplace as costs come down and technology continues to advance. In the near future, he also anticipates less invasive tests for colon cancer screening. “I think we will be entering the age of liquid biopsies where we are actually going to be able to identify molecules in the blood that are leaked out by polyps or tumors and will predict who is likely to have colon cancer or a large colon polyp,” he says. As these preventative measures develop, Jones plans to be an active participant and advocate. “I’m going to continue to pursue strategic communications and my interest in under- standing the genetics behind gastrointestinal illnesses,” Jones says. “In America, I don’t think we can afford to treat disease, but I do think we can afford to prevent it.” “The single greatest behavioral lifestyle issue with cancer is not being aware of screening and your family risk.” — Whitney Jones, MD Cover Story14 MD-UPDATE PHOTOS BY GiL DUNN Unifying Force Wayne Tuckson, MD, says combined efforts will improve the Commonwealth’s health outcomes BY JiM KELSEY LOUISVILLE From the first moment that Wayne Tuckson, MD, colorectal surgeon at KentuckyOne Health Colorectal Surgery Associates in Louisville, speaks, it is clear that he has a vision and desire to make a positive lasting impression on healthcare in Kentucky. “I’m just a humble colorectal surgeon who is very much interested in healthcare dispar- ities and what we can do to correct them,” says Tuckson, who attended the Howard University College of Medicine. In addition to his practice, Tuckson has host- ed “Kentucky Health” on KET for more than two decades. On the show he invites other phy- sicians, community leaders, and politicians for conversations about healthcare in the state. The overall concept is to inform and educate the state’s population about health and healthcare, which he believes is a critical step to decreasing disparities in health outcomes. Data shows that healthcare outcomes for African Americans and people of lower socio-economic status are worse than those of the overall population. Tuckson believes that, in this case, knowledge is power. “The health IQ in our community is bad,” he says. “When you look at people who do well, they tend to have a better understanding of what normal body function is, they are not intimidated by the healthcare system, and they tend to be more engaged with the healthcare system. These are people who tend to be better educated and better off financially. I can’t make anybody rich, but I can help educate people.” Tuckson believes so much in what he’s doing because he has seen it work first hand. In 2004, he participated in the launch of the Kentucky Colon Cancer Prevention Project, led by his colleague Whitney Jones, MD, gastroenterologist at Gastroenterology Health Partners in Louisville. Jones spearheaded the Colon Cancer Prevention Project because of his belief that “We’re spending a lot of money on insurance, but not enough on cancer prevention. The cost of cancer treatments totally overwhelms the cost of prevention,” says Jones. At the time the project launched, Kentucky ranked last in the nation in colon cancer prevention statis- tics and had the highest rates of incidence and mortality in the nation. “Whitney was sick of seeing people come in with advanced disease,” Tuckson says of Jones. “He was sick of having that conversation, of sending patients to a surgeon like me.” The ongoing work of the Kentucky Colon Cancer Prevention Project includes education, advocacy, survivor support, and health system change. The impact of the project is reflected in the state’s improvement versus the rest of the country. Kentucky now ranks 17 th best in the nation in the same colon cancer related categories and earned an American Cancer Society Achievement Award for the most improved state in the nation for colorectal screening over the past 15 years. “There are very few people we will meet in our lifetime of whom we can say this person made a difference in the health of our state,” Tuckson says. “Whitney Jones is one of those people. He saw a problem and he organized a method to correct it. What the Colon Cancer Prevention Project did was mobilize physicians and hospitals and other interested individuals to say, ‘We have to correct this problem.’ Whitney was able to get a bunch of doctors to work together to make sure we were getting more patients in for screening. There are people alive because of the Colon Cancer Prevention Project.” Tuckson said the next step in prevention of colon cancers and other cancers is to use genet- ic testing to identify individuals at high risk for these cancers, thus preventing these cancers. “There are people who are genetically pre- disposed to develop colon cancer. We need to identify them,” Tuckson says. “We need to start pushing people like our front-line clini- cians and primary care doctors to order the screening for their patients so we can look for these gene alterations.” Tuckson believes the same model of state- wide collaboration between healthcare systems, medical professionals, and legislators can make Kentucky a leader in genetic screening. In addi- tion to being better for the health of the state’s citizens, it also will help the state’s economy, Tuckson says. He cites the example of a colon cancer patient who might require $50,000 to $75,000 in medical care. Physically, that patient is unable to contribute to the economy and like- ly represents a net drag on the economy. “If you look at this strictly in terms of dol- lars and cents, what we spend to keep a person from developing colon cancer so that person doesn’t require chemotherapy, radiation ther- apy, or surgery, saves money,” Tuckson says. “Saving lives is the single most important thing, but if we don’t have the money, we can’t save the lives. That is why our legislators have recognized that this is a matter of common sense. We are keeping people alive while also improving productivity and cutting costs for our healthcare system.” How will Tuckson’s mission to improve the health IQ of Kentuckians reduce disparities in healthcare outcomes? Stay tuned. Wayne Tuckson, MD, has practiced as a colorectal surgeon in Louisville since 1994. SPECiAL SECTiON COLON CANCER-GASTROENTEROLOGYISSUE #124 15 Helping Women and Men Fulfill the Dream of Parenthood Fertility & Endocrine Associates bridges dual specialties to help patients achieve successful pregnancies BY MENISA MARSHALL LOUISVILLE In 1978 the world’s first baby conceived via in vitro fertilization (IVF) was born in Manchester, England. Fast forward 42 years, and today IVF is a mainstream treat- ment for infertility. IVF is just one of the many ways Fertility & Endocrine Associates (F&EA) can help patients achieve successful pregnancies. The practice’s main providers — Robert J. Homm, MD, Kit S. Devine, DNP, and Miriam S. Krause, MD — have 50 years of reproductive endocrinology and oncofertility experience between them. Homm was doing an obstetrics & gynecol- ogy residency in the 1980s when reproductive endocrinology became a recognized specialty. He completed a fellowship in the new disci- pline and attained dual board certification in both fields. In the 1990s, Homm helped found Kentucky’s first private reproductive endocri- nology and infertility practice in Lexington. He also launched the state’s first private IVF lab (now Louisville Reproductive Center) and has been its medical director since 1994. Krause, like Homm, is board certified in obstetrics & gynecology and reproductive endocrinology & infertility, a distinction few physicians hold. As a leader in both special- ties, she presents at many national conferences and has published numerous articles. She sees each patient as unique and focuses on provid- ing customized solutions for every family. Devine holds a doctorate in nursing prac- tice and is a licensed advanced practice regis- tered nurse and certified women’s health nurse practitioner. She had worked in two general PHOTOS BY GIL DUNN Drs. Robert Homm and Kit Devine performing an embryo transfer under sono-guidance. SPECIAL SECTION ONCOfERTILITY16 MD-UPDATE OB-GYN settings and served on the nursing faculty at two area universities before teaming up with Homm 17 years ago. She says with a smile, “I realized I was cut out to care for people instead of administrative tasks and budget sheets.” Preserving Fertility After a Cancer Diagnosis While Fertility & Endocrine Associates treats a wide range of complex issues, infer- tility related to a diagnosis of cancer presents special challenges. Cancer accounts for under 10 percent of infertility cases F&EA treats, yet it can be a shocking diagnosis. The good news, according to the National Cancer Institute, is that more people are sur- viving cancer. The United States saw about 15.5 million cancer survivors in 2016. By 2026 that number is expected to grow to 20.3 million. The less-than-good news is certain cancer treatments — particularly chemotherapy and radiation — may destroy a patient’s future potential to conceive children. For women, cancer treatment can damage the ovaries or oocytes (eggs) or lead to early menopause and other reproductive problems. For men it can damage their ability to produce viable sperm. The F&EA team encourages oncologists and surgeons to refer patients with cancer to an oncofertility specialist. They agree that raising awareness is “a crucial need” so more patients of childbearing age routinely under- stand their fertility preservation options. Devine says that F&EA has all kinds of resources and ways to help cancer patients. They can mobilize quickly since timing is often critical and decisions must often be made prior to the start of treatments. “The process of preserving eggs or sperm can actual- ly be very fast,” Dr. Devine said. “We’re often able to see patients the same day or the very next day after they contact us.” According to Krause, when it comes to retrieving and quickly freezing eggs or pre- serving embryos, advanced technologies and procedures are “real game changers.” Preserving sperm has long been a relatively simple procedure but because eggs are rela- tively larger cells with a high water content, they are been more prone to damage during freezing and thawing processes. Using vitrification, a new ultra-rapid pro- cess, eggs are quickly plunged into liquid nitrogen. This lessens potential damage and allows 99 percent of eggs and embryos to survive freeze and thaw cycles. Krause points out that even when patients undergo cancer treatment prior to taking action to preserve their fertility, there is still hope for parenthood. Some patients may opt to utilize third-party reproduction which involves using donated sperm, eggs, or embryos to become pregnant. The office serves as a regional referral center for embryo adoption services in the southeast area. Beyond this, the group often writes letters of support for patients who decide to pursue traditional adoption. Tackling Other Infertility Challenges Beyond cancer, any number of other issues or conditions can cause infertility. The Centers for Disease Control and Prevention report about 10 percent of women ages 15 to 44 in the United States expe- Raising awareness is “a crucial need” so more patients of childbearing age routinely understand their fertility preservation options. Robert J. Homm, MD, helped found Kentucky’s first private reproductive endocri- nology and infertility practice in Lexington. Kit S. Devine, DNP, holds a doctorate in nursing practice, is a licensed APRN and certified women’s health nurse practitioner. Liquid nitrogen dewar used for storage of vitrified oocytes, embryos (E3) or sperm (S2). SPECIAL SECTION ONCOfERTILITYISSUE #124 17 rience infertility. About one-third of cases involve problems unique to females; one- third involves problems unique to males. The remaining third is typically a combination of issues that can affect both genders or stem from unknown causes. F&EA is uniquely qualified to address a diverse range of complex gynecological issues. Three common conditions they see are: Hormonal abnormalities that cause irregu- lar menstrual cycles or a total lack of menses. Polycystic ovary syndrome (PCOS), which typically causes irregular ovulation and is often corrected with hormone therapy. Uterine fibroids are non-cancerous growths that develop from muscle tissue inside or on the uterine surface and can cause pain, pres- sure, an enlarged uterus, and menstruation problems. They can typically be removed during outpatient surgery. Looking Ahead, Building Capacity F&EA recently updated its space and added state-of-the-art technology and equipment. They enlisted advice from a top design com- pany and noted chemical hygienist, Antonia Gilligan, CEO of Alpha Environmental, Inc. who specializes in IVF laboratory design. At a time when many medical practices are affiliated with specific hospital systems, F&EA remains independent. “Being inde- pendent gives us more flexibility and time to spend with each person so we can deliver indi- vidualized care to meet each patient’s unique needs,” says Homm. Looking ahead, genetic testing is an area of growing interest. Next generation sequencing technology can be used to screen embryos for a variety of genetic abnormalities. For exam- ple, if a patient carries BRCA 1 or 2 genes, her embryos can be screened for these genes, commonly associated with increased risks for breast and ovarian cancer. Another future focus is encouraging insur- ance coverage for fertility preservation proce- dures. Now in its relative infancy, fertility-re- lated services receive essentially no coverage. This has changed somewhat, but F&EA says there is room for improvement. As to what lies ahead, Devine sums it up with one word: Hope. “We are devoted to helping those who walk through our doors with little hope of fulfilling their dreams to become parents,” she says. Dr. Miriam Krause receiving an embryo in a transfer catheter from the embryologist. The embryo will be transferred into the uterus. Miriam S. Krause, MD, is board certified in OB-GYN and reproductive endocrinology & infertility. SPECIAL SECTION ONCOfERTILITYNext >