State’s First AI Image-guided Endoscopy Suite Opens at Grandview
By marti WeBB SLay
Grandview Medical Center has opened a new artificial intelligence image-guided advanced endoscopy suite, the first in Alabama.
This unit is specifically designed for gastroenterological procedures. “Fluoroscopy can be used in many specialties such as orthopedic surgery, neurosurgery, pulmonology, and so on,” said Mohannad Dugum, MD, director of Advanced Endoscopy at Grandview. “This is designed for GI procedures. That means the way it’s structured, the movements of the arms, and the bed is all geared toward what we do.”
Fluoroscopy uses x-rays for several
advanced endoscopy procedures, including endoscopic retrograde cholangiopancreatography (ERCP), which aids in the diagnosis and treatment of benign and malignant diseases of the bile duct and pancreas. Fluoroscopy is also used to assist with the placement of stents in the GI tract, relieving blockages due to benign conditions and cancers of the esophagus, stomach, small intestine, and colon.
The new fluoroscopy unit provides a high-quality image while reducing radiation for the patient and medical staff.
“The AI capability uses very sophisticated algorithms,” Dugum said. “During the procedure, it recognizes which part of the GI tract I’m focused on, mainly
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Research to Extend Human Life and Health Spans is Exploding
By Steve SpenCer
In recent years, there has been growing interest in the science of aging with researchers focused on why people age and how we can combat it. According to Matt Kaeberlein, PhD, a biologist at the University of Washington School of Medicine, “biological aging is the root cause of most major diseases in developed countries.” Therefore, if scientists can find therapies to slow biological aging, we might be better protected from debilitating illnesses like cardiac disease and cancer.
Exercise
Nothing, other than calorie restriction, is as beneficial to healthy aging as exercise. For example, 10 years ago, researchers in the UK examined 125 amateur cyclists between 55 and 79, and compared them to adults in the same age range who didn’t exercise regularly. The cyclists didn’t lose muscle or much bone mass, both of which have been assumed to be inevitable in aging. The biggest surprise was related to the thymus gland, which affects immune function. It normally shrinks in older people, (CONTINUED ON PAGE 3)
Photo: Mohannad Dugum, MD with the new AI endoscopy suite.
Steven Austad, PhD
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State’s First AI Image-guided Endoscopy Suite Opens
by looking at the scope tip and the devices and why we are utilizing them. The machine recognizes that on its own and is able to focus the radiation only on the field of interest. By doing that live during the procedure, it is minimizing the release of radiation to the patient, to me and to the rest of the staff, so it’s very beneficial without any reduction in the quality of image.
“In fact, because it’s focusing the radiation on a smaller field, it’s able to enhance the image so we’re actually seeing better with a higher-quality image, but at
the same time, the amount of radiation being released and the side effects of that radiation are being reduced by upward of 80 percent according to studies. Less radiation time translates into faster procedural times, and less time under anesthesia, which is always good for patients. Although there is no data yet, we feel less time to interpret an image translates to an enhanced procedure, and better patient satisfaction, all with a much-improved radiation safety profile.
No extra training is required to use the new technology. “There is no addi-
at Grandview,
tional training, because the AI is built into the machine itself,” he said. “Imagine when I am doing the procedure, I’m looking at a 36 inch screen, but I’m only really looking at probably 10 square inches. So this machine is doing is focusing on the 10 inches, and it minimizes and blurs down – not to a very high level – the remainder part of the screen. That’s how it works, and you can shut off the AI part of it and see everything with the maximum radiation, so if you need to see that for any reason, you can shut off that extra layer of AI capacity.
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“AI image-guided fluoroscopy is not yet standard in Alabama, but it is the standard and has been used in multiple endoscopy labs at high-level medical institutions throughout the country. It has been available for three to four years, and they continue to update it, so we got the latest version. The importance of this is we brought this modern technology to the state, and I think it’s going to continue to open doors for other GI labs to acquire a unit like this.”
Research to Extend Human Life and Health Spans is Exploding,
but it didn’t in the cyclists.
Another marker of fitness is VO2 Max. This is a measure of how much oxygen you can consume and use during cardiovascular exercise. A study in JAMA8 that followed over 120,000 people found that a person in the bottom quartile for their age and sex in VO2 Max is at double the risk of all-cause mortality than someone in the top quartile. You can improve your VO2 Max with regular cardio exercise.
Rapamycin and Metformin
There are currently two drugs that a number of Americans are using off-label in an attempt to stay healthier longer.
Rapamycin is an antifungal compound that was discovered on Easter Island in the 1960s. It’s used in high doses in organ transplants to help prevent rejection of the donor organ. About 20 years ago, information began to emerge suggesting that at lower doses rapamycin extended lifespan in mice. About 30 studies have been done, including six with the rigorous Interventions Testing Program, and all yielded positive results. One study found that Rapamycin, which inhibits mTOR kinase, increased median lifespan of genetically heterogeneous mice by 23 percent for males to 26 percent for females.
It’s estimated that around 5,000 people take Rapamycin off-label in an effort to extend health/lifespan. Unfortunately, because the patent on Rapamycin has expired, pharmaceutical companies aren’t interested in performing studies.
The other popular off-label longevity drug is Metformin which is used as a treatment for diabetes. In 2017, Jared Campbell at the University of New South Wales in Sydney, Australia ran a meta-analysis on Metformin, finding that it reduced all-cause mortality and diseases of aging, independent of its effect on diabetes control.
Preliminary studies suggest that metformin’s positive effect on life expectancy may result from improving the body’s responsiveness to insulin, antioxi-
dant effects, and improving blood vessel health, but more research needs to be done. With that in mind, Nir Barzilai, MD, the director of the Institute for Aging Research at the Albert Einstein College of Medicine, leads a group that wants to conduct the Targeting Aging with Metformin (TAME) trial to test whether metformin is capable of delaying the onset of age-related diseases including cancer, cardiovascular disease, and Alzheimer’s. The group has had a difficult time raising money for the trial because, like Rapamycin, Metformin is off patent. At this time, they may begin with trial with partial funding.
Polypill
“About 20 years ago, a couple of British physicians said that if everybody in Britain over age 55 took one pill a day, they could cut cardiovascular deaths by 80 percent,” said Steven Austad, PhD, Chair of the Department of Biology at UAB. “The pill consisted of three low dose anti-hypertensives, a statin, and a couple of other things like aspirin and folic acid. The National Health Service wouldn’t buy into it so it didn’t go anywhere.
“Since then, there have been around a dozen small studies all over the world, including one here in Alabama, that showed it always works. The Alabama study included the most disadvantaged people, and it lowered their blood pressure and their cholesterol. The researchers calculated that it would have lowered heart attacks by 30 percent over the next 10 years.
“With so many disadvantaged people in Alabama, I would create a polypill with anti-hypertensives, a statin, and low dose metformin. The idea is to do a low dose of three anti-hypertensives that all work through different mechanisms. The polypill has several advantages: because these are generic drugs, it’s inexpensive, and it has all your medications in one pill which should help people stick with it. I want to work up a study with this in Alabama.”
Yamanaka Factors
In 2006, Shinya Yamanaka, a geneticist at Kyoto University in Japan, found that four proteins, now called Yamanaka Factors, could reset epigenetic markers which turned adult cells back into pluripotent stem cells. Researchers across the globe were excited about this finding, which earned Yamanaka the Nobel Prize in Medicine, because it opened the possibility of resetting people’s cells which might allow scientists to treat diseases using cells derived from patients’ own tissues, and possibly even reverse some aspects of aging.
continued from page 1
However, pluripotent stem cells can turn into cancerous cells, making the endeavor incredibly risky. Recently, some researchers have approached this problem by using only three of the four Yamanaka Factors, while others have limited the time that adult cells are exposed to Yamanaka Factors.
Recently, San Diego–based Rejuvenate Bio injected 124-week-old mice with adeno-associated viruses (AAVs) carrying genes for three of the factors. These mice lived another 18 weeks on average, compared with nine weeks for
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a control group They also partially regained patterns of DNA methylation that are typical of younger animals. “I would say it’s provocative - possibly a breakthrough,” Austad said. “But it will need to be replicated and the mechanism explored before we can say for sure.”
A Plan to Improve Mice Study Results
Even with some of these encouraging results, it’s been very difficult to translate positive findings in mice studies to humans with a failure rate of over 90 percent.
“We keep them in cages where they get no stimulation, and little to no exercise,” Austad said. “We protect them from microbes so they have a neonatal immune system. It’s like they’ve been raised in a bubble. Some friends of mine did a study with some drugs to see if they improved COVID outcomes with mice. They bought some mice from the pet store and they put their laboratory mice in the cage with the pet store mice, and the lab mice were all dead within two weeks. All they did was put them on
continued from page 3
the bedding of the pet store mice that were perfectly healthy. It exposed the lab-bred mice to microbes they’d never seen. So it’s not surprising that mice to human studies rarely pan out.
“I would like to make a more natural environment. If I get funding, I’m going to build an environment like that for testing, and use rats instead of mice. I would build an indoor/outdoor thing, like a small barn. I wouldn’t put it outdoors because of rain, but I would allow for temperature variations, daily and seasonal variations. I would use dirt rather than bedding to give the rats exposure to normal microbes.”
The Future
Longevity research is moving fast. There’s no guarantee that research will yield significant benefits, but by tackling the challenges of an aging population head-on, anti-aging research holds the promise of transforming the way we age, enhancing our overall wellbeing, and fostering a healthier and more vibrant global community.
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OUR HERO (IS THIS YOU?):
Our HERO is the ambitious Practice Manager whose life is wrapped up in the success of the business – income, mortgage, retirement, even the kids’ college. They have a sense of humor but are constantly thinking about ways to improve their business, maximize productivity, and MANAGE RISK. They’re passionate about their business and take it personally when a competitor, hacker, or employee threatens their mission to improve the world.
- By Marty Stempniak | October 17, 2024 | radiologybusiness.com Senators propose removing limits on HIPAA fines
OUR ENEMY:
- By Brittany Trang | Oct. 23, 2024 | STATnews.com Disruptive Cyberattacks Against Healthcare on the Rise
Apathetic or complacent US businesses who are willing to accept UNLIMITED RISK by ignoring today’s threats. Business owners who think, “it won’t ever happen to me.” Foreign Governments seeking footholds in the US or leverage. Cybercriminals who believe that all Americans are rich and therefore justified targets. Global crime syndicates who employ thousands in an Enterprise organizational structure. IT and Cybersecurity companies who take advantage of unwitting customers with Projects and Hourly Billing. The Cybersecurity industry as a whole, which has bored and confused the entire US public into a state of wanton vulnerability, while the hackers get better every day.
WHO/WHAT ARE WE FOR:
- By Dave Muoio | Oct 9, 2024 | fiercehealthcare.com
Schedule a 10-minute discovery call, and we’ll donate $150 in your name to Hand in Paw. Radiology practice must pay $1.85M to settle class action lawsuit from cyberattack
Practice Managers who are mature enough to understand that THEY OWN ALL THEIR COMPANY’S RISK, and who are willing to have routine, honest, and candid discussions about CYBER RISK MANAGEMENT and CYBERSECURITY / REGULATORY COMPLIANCE. They understand that by getting buttoned up and taking RISK seriously, they can maximize productivity, retire earlier, and send the kids to college debt-free. We are for HAVING FUN while making clients SAFER FROM CYBERCRIME. You know, CybertechnoLOLogy!
WHO/WHAT ARE WE AGAINST:
The solo “IT Guy” who doesn’t have the time, desire, or skills to keep up with ever-changing threats and subsequent countermeasures. Technology companies that baffle their customers into spending money on things they don’t need. MIND-NUMBING CYBERSECURITY TRAINING AND CONTENT that BORES AND CONFUSES NORMAL PEOPLE INTO NEVER GETTING ANY SAFER FROM CYBERCRIME. ANTIcybertechnoLOLogy.
CybertechnoLOLogist www.sipoasis.com
The Physician Shortage in Alabama and the Looming Crisis
By Laura Freeman
Does Alabama have too few physicians or not enough of the right kind in the right place? Maybe the answer is both. As in other states, getting an appointment with a primary care physician or specialist within a reasonable time frame can be challenging. So much depends on where you live, how much you can afford to pay, whether you have insurance and if the physician you need is in network or accepts Medicare and Medicaid, or is even accepting new patients.
“We have many rural counties that are underserved,” said Joni Wyatt, MHA, MHIA, CPHIMS, who is a Director of the Healthcare Advisory at Kassouf. “In specialties like women’s health, there are deserts where patients drive a hundred miles to see an obstetrician or gynecologist. At the same time, in other locations near metropolitan centers, in some specialties we have clusters of physician in excess of the number needed for the population. For example, in Birmingham we have 130 more primary care physicians than our population predicts we
need. In Athens, we have seven too few, in Oneonta 13 too few, and 17 too few in Pell City. On the other hand, Huntsville, Scottsboro, Decatur and Muscle Shoals have more primary care physicians than their population would predict.”
For practicing physicians, local shortages in some specialties create a referral urgency problem. If, for example, a patient has a creeping calcium level that could turn into kidney damage, it might be dangerous to for a referring physician to wait when appointments for referrals
Alabama DDS Needs
take an excessive amount of time.
Why has the imbalance of physicians in rural and urban areas developed? Physicians tend to live near hospitals where they can train, work and refer patients, and many rural hospitals have closed. Some specialties focus on rare disorders and require a broader population for enough cases to sustain a practice. The biggest factor is probably lifestyle. Physicians often prefer the access to cultural events, services, and interaction with other medical colleagues that a city provides. They want good schools, libraries and activities for their kids and career opportunities for their spouses.
“The 2023 Alabama Physician Workforce Act was passed to help to ease shortages,” Wyatt said. “It streamlines the process and time required to license physicians who move here from other states and countries. It also set up programs for physicians who didn’t match other residency programs. The legislature has also considered expanding the scope of practice for health professionals who can ease the workload for physicians in specific areas of care.”
While getting off to a slow start, the number of nurse practitioners in primary and specialty care in Alabama is now growing rapidly. From near the bottom of the list in number of nurse practitioners, our state is now #3 in fastest growth, with a projected growth of 54 percent in the near future.
“Nurse practitioners and physician assistants are working to extend care which frees physicians to work where they are most needed,” Wyatt said. “There are also technologies that can give a physician more time.”
One area where physicians are overwhelmed is in trying to keep up with new information. “More data is coming in than any one person can read,” Wyatt said. “Physicians want to stay current to give their patients the best care possible. There are services that collect new medical information and organize it summary points physicians can listen to it while they are doing other things. When they want to know more about something they hear, they can look up expanded details.”
“Estimates of how bad the physician shortage will be in ten years vary widely
(CONTINUED
Joni Wyatt, MHA
Combining Artificial Intelligence with Genetics to Create Personalized Medicine
By Laura Freeman
“Since mapping the human genome, we’ve identified 10,000 and counting genetic factors influencing diseases. In some of those conditions, particularly where a single gene controls changes, we are making real progress in using what we’ve learned to improve outcomes,” Matt Might, PhD, Director of the Hugh Kaul Precision Medicine Institute at the UAB Heersink School of Medicine, said.
One case in point is an already approved drug now showing promise in treating symptoms in a form of autism related to a rare genetic mutation that causes a deficiency in activity-dependent neuroprotective protein (ADNP).
Matt Davis, MD, a neurosurgical resident at UAB, asked the precision medical team for help with his son, Benjamin, who had been born with ADNP syndrome. Because children with this syndrome have only one good copy of this gene, they don’t produce enough of this protein. According to the NIH, ADNP deficiency causes developmental delays and other symptoms found in autism. It can affect fine motor skills, hearing, vision, muscle tone, the heart, the immune, endocrine and gastrointestinal system, as well as the brain and behavior.
“We wanted to help Benjamin, and this seemed to be the perfect challenge for mediKanren, the AI tool our precision medicine institute developed with the help of funding from the National Center for Advancing Translational Science,” Might said.
In what may be the first time an AI tool produced enough evidence to gain approval for an FDA clinical trial, the precision medicine team began loading all data known about Benjamin’s case and that of a second patient, then instructed it to explore all available medical literature to seek out therapeutic agents that might be beneficial in treating the disorder.
The AI returned a strong response—low dose ketamine is an upregulator of the protein governed by the ADNP. It has been used as an FDA approved safe and effective therapy for decades.
“Ketamine was originally known for its use in veterinary medicine anes -
thesia and is now being used in humans for pain management and depression,” Might said.
After identifying low dose Ketamine as a potential therapeutic agent, the Precision Medicine Institute sent its findings to the ADNP Kids Research Foundation, which relayed it to the Seaver Autism Center For Research And Treatment at Mount Sinai Hospital. The center ran a preliminary clinical study that confirmed that ketamine is effective in increasing protein level. The response was strong enough that a broader clinical trial is in development.
Another area where the crossroads of genetics and AI could make a difference in the course of custom-tailored care for individual patients is cancer treatment.
“Each tumor has its own unique genetic code, and the code may be different in a second tumor in the same patient,” Might said. “It may also continue to mutate over time and become a moving target. If we can sequence the unique code of a tumor, we can use our AI tool to look for the treatment strategies most likely to be effective against it. Then we can sequence it again as needed to monitor changes.
“When you see the genetic sequence for a cancer cell, you may be surprised. For example, we had a patient with an aggressive prostate cancer. We expected it to come back identified as prostate cancer, since that was where it was located. But this particular sample had a profile that looked like a cancer usually found only in women. So we adjusted therapy to use the same strategy we would use in
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If you suffer from allergies or other ear, nose, throat or hearing problems, we don’t want you to treat your healthcare lightly or ignore symptoms that could lead to more serious issues. Call us now for a complete evaluation with one of our 16 board certified physicians, 5 highly trained and licensed PAs, or 16 clinical audiologists — all available to serve your needs at any of our 10 locations.
Matt Might, PhD
Covid Immunity Upheld To Protect Health Care Providers
By: angie Cameron Smith
On October 4, 2024, the Alabama Supreme Court issued an opinion confirming and upholding the validity of not only the Governor’s Executive Order of May 8, 2020, providing immunity from negligence claims during the COVID-19 pandemic, but also the COVID immunity statute passed by the Alabama Legislature in the 2021 legislative session.
Background
The Governor’s Executive Order (the “Order”) stated that due to the public health emergency, “reasonable protections from the risk and expense of lawsuits” were necessary to allow businesses to re-open and provide “safe harbors for health care providers that operate reasonably consistent with applicable public health guidance.” The Order provided legal immunity to health care providers for conduct in connection with the treatment of COVID-19. The Order issued under the Governor’s authority granted to her under the Alabama Emergency Management Act (“AEMA”).
Following the May 8, 2020 Order, the Alabama Legislature enacted, and the Governor signed into law, the Alabama COVID Immunity Act (“ACIA”) in the 2021 Legislative Session. The ACIA ratified and adopted the same safeguards and legal-liability immunity contained in
the Governor’s proclamation. The ACIA was effective February 12, 2021, but the statute specifically states that it is to be applied retroactively to lawsuits filed on or after March 13, 2020.
Wrongful Death Medical Malpractice Claim
In the case against Jackson Hospital, the estate of a patient brought a wrongful death lawsuit alleging that the hospital was negligent in the care of a patient with COVID-19. The lawsuit alleged that the hospital failed to properly apply oxygen for a patient with COVID-19 while transferring him from one floor of the hospital to another, and he subsequently died. The death occurred after Governor Ivey issued the emergency proclamation but
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before the Legislature enacted the ACIA. The hospital answered the complaint and asserted COVID immunity. Following some initial discovery, the hospital asked the court to dismiss the case based on the Governor’s emergency proclamation. The plaintiff argued not only that the Governor’s Order exceeded her powers and was unconstitutional, but also that the ACIA was unconstitutional and could not be applied retroactively. The trial court denied the motion for summary judgment and held that the claims could proceed under an “exception” to the ACIA, which states that claims can proceed if either the other
immunity provisions of the ACIA or the gubernatorial emergency order does not apply. The trial court did not address any constitutional arguments made by the parties. The hospital sought immediate relief from the court’s denial with the Alabama Supreme Court.
Alabama Supreme Court’s Decision
In a 7-1 decision, the Alabama Supreme Court not only held that the Governor’s Executive Order was a proper exercise of her authority under the AEMA, but that the ACIA’s retroactive provisions were applicable to the case. The Court stated that the ACIA provides “broad immunity to health care providers from negligence actions stemming from medical care provided in relation to the COVID-19 pandemic.” There was no question that the care provided was related to COVID-19. Therefore, the court held that the plain language of the COVID statute made the hospital immune from suit.
Although the plaintiff argued that the retroactive application of the statute was unconstitutional because her cause of action had vested prior to the enactment of the ACIA, the Court found that the Governor’s proclamation was a proper exercise of power thereby preventing the cause of action from vesting. The Court also noted that the Legislature had explicitly ratified the Executive Order at the time it passed the ACIA. This is the second case where the Alabama Supreme Court has upheld the enforceability and application of COVID immunity. The first case was Ex parte Triad, 2024 WL 295247 (Ala. 2024), which involved a less direct COVID connection. In that case, the plaintiff tripped and fell while leaving the hospital after receiving treatment for COVID-19. The Court held that because the patient/injured party had to use a specific entrance to obtain treatment for COVID-19, the ACIA applied to her claims.
What It Means For Future Claims?
Although these cases are helpful for those claims that accrued during the pandemic, the ACIA terminated by its terms as of “December 31, 2021, or one year after a declared health emergency relating to Coronavirus expires, whichever is later.” The public health emergency ended on October 31, 2021; therefore, the ACIA terminated on October 31, 2022. Any claims related to COVID-19 that accrued after that date would not be covered by the ACIA.
Angie Cameron Smith is a Partner at Burr & Forman LLP practicing exclusively in the firm’s Health Care Practice Group. Angie may be reached at (205) 458-5209 or acsmith@burr.com.
Angie Cameron
The Physician Shortage in Alabama and the Looming Crisis
with projections across the U.S. ranging from 13,000 assuming we do all we can starting now to 86,000 if we don’t. One estimate pushes the shortfall to 139,000 if we don’t do more to expand medical education.
“We are losing too many experienced physicians to burnout. Younger physicians coming into medicine have different expectations. They want balance in life and expect to be able to do good work and still have time for family and the things they enjoy. We have to solve the work/life balance to keep physicians and
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attract more. We need to interest more students in medicine and make the life they can have in that career as attractive as other options.” If doctors come out of school owing as much for their training as the mortgage on a house, it’s hard to pay for both. More scholarships and grants are needed to cover some of the costs.
In order to keep this problem from devolving into a crisis, it will take the best efforts of many people working together to get where we need to be in the next decade.
Combining Artificial Intelligence with Genetics to Create Personalized Medicine,
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a female patient. It worked.”
The list of genetic diseases humans are heirs to is long, and whether a possibility becomes a probability sometimes depends on changes brought on at the molecular level by epigenetic factors and other infl uences that can turn a blueprint for trouble into an active attacker. Even in disorders where a genetic causal relationship hasn’t been established, how each patient responds to a treatment can vary according to the specifi c genetic profi le. Beyond helping clinicians choose the approach to treatment most likely to be successful, an AI analysis of a patient’s genetic profile can also provide valuable clues in undiagnosed illnesses.
“Some diseases are diffi cult to diagnose and we see quite a few cases that are unlike anything we’ve ever seen before,” Might said. “AI can give us clues about what might work and parallels to similar conditions and what worked for them. Most of all, it tells us not just what the genetic sequence is, but what it might mean.”
From a background in computer science, Might was led to a career in precision medicine by a personal quest
to put a name on his own son’s illness and fi nd a treatment for it. Bertrand was the first patient in the world identified has having an NGLY1 deficiency. After working in the White House in President Obama’s Precision Medicine Initiative, Might came to UAB to lead the institute. Now he and his team are helping others find answers at the end of their quest and perhaps discover a pathway to better outcomes. Better yet, precision medicine is now identifying more genetically-linked disorders early enough to change the course of their progression and prevent a genetic predisposition from turning into a disaster.
“My genes make it more likely that I could develop macular degeneration, so I’m doing everything I can to keep my eyes healthy and monitor for early signs of changes,” Might said. “Other people may fi nd that they are predisposed to heart disease, diabetes, a specifi c type of cancer, dementia or a whole list of other disorders. Knowledge is power, and learning the risks early gives us an opportunity to rewrite our future. That is the ultimate promise of precision medicine.
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New Biologic Therapies Help Psoriasis Patients Obtain 100 Percent Clear Skin
By Lauren JohnSton
At Children’s of Alabama, kids are the center of our world and our mission is to provide the very best care available to every child. It’s why we are here.
Over the past 20 years, dermatologist James Krell, MD has seen dramatic improvements in treatments for psoriasis patients.
“It’s very encouraging,” he said. “When I started treating patients with psoriasis in the early 1990s, I did lots of phototherapy and widespread, relatively unsafe, immunosuppressive therapy. Now we’re putting patients on very safe biologic drugs that get them completely clear.”
In the 1980s and 1990s, physicians treated psoriasis with a broad variety of therapies, but the most common was phototherapy, which is ultraviolet light therapy. Patients would receive this treatment two or three times a week to clear up their skin. Other immunosuppressive therapies were commonly used, but had side effects.
Psoriasis is a chronic inflammatory skin disease that causes red, itchy plaques in certain areas of the body, commonly the scalp, elbows, knees, and buttocks. The most common type is plaque psoriasis. The less common types include guttate psoriasis, pustular psoriasis, and erythrodermic psoriasis. On average, patients typically see the first signs of this skin disease when they are in their mid to late 20s. Researchers are still studying the causes of this disease and working to identify the genes that effect it.
“About 30 percent of psoriasis patients inherit it from a family member, but that means that it just occurs in about 70 percent of the cases, which we call de novo (on its own). We’re not sure why someone might get psoriasis in the absence of family history. One exception is the second most common form, guttate psoriasis,” Krell said. This form, which is also called dew drop psoriasis, is usually caused by an underlying strep infection. It leaves red, teardrop-shaped spots on the skin like sprinkled dew drops.
While there is no cure for psoriasis, new research and medications within the last 20 years have greatly improved the treatment physicians can offer. Krell conducts psoriasis clinical trials and receives referrals from across the state for patients with challenging and rare cases.
“In the late 80s, no one thought psoriasis was based on the immune system,” Krell said. “Then there was a patient who got a transplant and was put on immunosuppressive therapy to protect them from rejecting the donated organ. This patient had psoriasis, and all their psoriasis disappeared. From that point on, people recognized that this is an immune-based disease. Then researchers tried to identify the immune-based causes, but they weren’t able to find any answers.”
In the early 2000s, researchers discovered that overproduction of certain protein cells was a leading cause for psoriasis. Pharmaceutical companies then began to identify medication that would target these protein cells that are overwhelming the body.
“In the last two decades, we’ve gotten new biologic therapies that mimic the biologic process in the body, but try to block those overproduced proteins,” Krell said.
These proteins are produced by cells like the T helper 17 (Th17) and interleukin-23 (IL-23), which are key drivers of psoriasis. Blocking the production of these cells dramatically slows down the disease. With these new biological therapy options, Krell can help most patients obtain completely clear skin.
“I have seen many patients go from widespread psoriasis with a miserable lifestyle to 100 percent clear with a new look on life,” Krell said. “The most recent drug that was approved for psoriasis has shown that somewhere around 70 percent of patients are completely clear after one year. That is remarkable.”
Today, there are about 11 different biologic therapies made by a variety of companies that are approved to treat this disease. Because biological medications are very large proteins, the medicine is usually injected as a shot, but there are two therapies on the market that can be taken orally. The injection form is selfadministered at home and can be given as frequently as once a week or as infrequently as once every three months.
Krell has seen improvements in treatments for some of the rarer types of psoriasis, including generalized pustular psoriasis, where a patient develops waves of painful plaques studded with pustules. There is also ongoing research for better topical medications, and every few years an improved type enters the market for physicians to prescribe.
“I’m very hopeful to be able to say to a patient every single day, ‘Don’t worry,
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James Krell, MD
Treating Osteoporosis
By Steve SpenCer
With 54 million Americans estimated to suffer from osteoporosis, this problem is only becoming more serious as our population ages. Many people are unaware that they have osteoporosis because we can’t feel our bones weakening. Reports have shown one in two women and up to one in four men over age 50 will break a bone due to osteoporosis.
With this in mind, Chris Heck, MD, a spine surgeon, started an osteoporosis clinic to go along with his practice at Southlake Orthopaedics. The motivation came about ten years ago when Heck had a patient return six months after he had repaired her broken hip.
“I assumed she was having more hip problems,” Heck said. “But she told me her hip felt great. She said that after I sent her to her primary care doctor, he told her that osteoporosis was a bone problem so she should see an orthopedist. I realized that if I’m not treating them, and I sent them to another doctor, and they’re not treating them then the patient’s just getting lost, falling into a never-ending loop.
“The clinic stays busy. Most of our referrals come from primary care physicians, OB/GYNs, and rheumatologists. The first thing we do with a new patient is get a bone density (DEXA scan) which
gives us a risk assessment for bone fractures. It lets us know how thin your bones really are.”
After the DEXA scan, the clinic team gets the patient’s blood work. This is done primarily to check the patient’s kidney function because some osteoporosis medications, like Fosamax, can be harmful to the kidneys.
Heck and Lauren Bannon, PA, who serves as an osteoporosis specialist, also examine various hormone levels in the blood work. “In some evaluations, we’ve found benign tumors that secreted hormones that caused the bones to be weak,” Heck said. “If you don’t correct that problem, treatments for the osteoporosis won’t be effective. We’ll also check for low testosterone with male patients be-
cause that can be a factor. We finish with a 30 minute consultation where we go through personal history family, among other things.
Latinos have lower rates.
There are several different treatment modalities for osteoporosis. Anti-resorptives were the earliest osteoporosis medications. This class of drugs, called bisphosphonates, are used to keep your body from resorbing the minerals out of your bones. Bisphosphonates include Fosamax, Boniva, and Reclast.
But what if your bone density is already very low? Bisphosphonates may keep it from getting worse, but if the bones are already thin, the patient is still at risk. If, while on these drugs, the patient still has fractures, Heck considers anabolic osteoporosis drugs.
“These drugs grow bone,” Heck said. “They are a little more high maintenance because they’re typically injectable and are usually done daily at home. There are some newer ones now that can be done with a monthly injection. But anabolics are only approved from one to two years. So at the conclusion of making your bone density go up with the anabolics, then you get on bisphosphonates (anti-resorptives) for life.
“Osteoporosis is a condition where your body resorbs minerals from your bones. Your bones are strong because it’s a latticework of minerals and bone. Without the minerals, the bone has nowhere to grow. From the time we’re born, our bone density increases until about age 30. After the decade of our 30s, all of us start to lose bone density at a rate of about three percent per year. When women hit menopause, they start losing at about 10 percent per year. Men will also get osteoporosis, but it’s about 20 years later than women. So most of our female patients are in their 60s and most of the males are in their 80s.”
There are some variables with racial backgrounds, as well. Caucasians and Japanese have a much higher rate of osteoporosis while African Americans and
“Preventing and managing osteoporosis is so much more important than people think. Studies have found that one in three hip fracture patients will die within 12 months. They won’t die of the hip fracture. They die of the complications of the fracture. So dealing with osteoporosis is the epitome of preventative medicine.”
New Biologic Therapies Help Psoriasis,
continued from page 10
I will get your psoriasis 100% clear or close to it.’ I was never able to say that 20 years ago, even 10 years ago, but now I say it to almost every new patient that walks in the door,” Krell said.
In the future of psoriasis treatment,
Krell predicts more affordable treatments, more oral biologic medications, more patients treated in the earlier stages, and less untreated psoriasis. He’s also hopeful that there will be fewer associated comorbidities, like depression.
Yvonne Conway, MD
Orthopedic Surgeon | Foot & Ankle | OrthoSports Associates
Chris Heck, MD
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Five Things to Consider When Negotiating Business Associate Agreements
By ShaLyn WatkinS
Signing a Business Associate Agreement (BAA) is a standard practice for most healthcare providers and businesses. The Health Insurance Portability and Accountability Act (HIPAA) requires that covered entities, business associates and downstream business associate subcontractors enter into a BAA when contracting for services that require the sharing of Protected Health Information (PHI) outside the organization. However, it is a common misconception that the agreements are boilerplate. Some parties either fail to read and negotiate the terms of the BAA or, worse, forego executing the agreement altogether. This is not an advisable practice, however, because BAAs are critically important and can make or break a compliance program if they are not taken seriously.
Though BAAs may appear to be standard attachments to service agreements, they are not standard boilerplate, and therefore require careful review and consideration. This article will highlight five key things that parties should consider when negotiating a BAA.
1. Make Certain Your BAA Is Compliant – and That You Have One
Many parties fail to comply to the basic formalities required under HIPAA
even though the requirements for BAAs are defined in federal regulations. Standard confidentiality agreements or nondisclosure agreements do not meet these requirements. The failure to execute a BAA can be a HIPAA violation that results in severe monetary fines. Disclosure of PHI in the absence of an executed BAA is an impermissible disclosure and potentially a HIPAA breach requiring notice.
2. Clarify Unclear Reporting Obligations
Some BAAs attempt to pass the covered entity's obligation to report breaches to the business associate. This delegation is permissible under HIPAA, but sometimes the business associate is not in the ideal position to notify the required par-
ties. It is important that business associates accepting this responsibility clarify their reporting obligations and ensure they have the infrastructure to report breaches to individuals, the Secretary of the U.S. Department of Health and Human Services (HHS) and the media when required by law. The HHS Office of Civil Rights (OCR) has been clear that covered entities are ultimately responsible for ensuring that notice is provided in compliance with the breach notification regulations in HIPAA, but failure to perform the delegated notifications may create distrust between the parties and could result in the termination of the underlying Service Agreement.
3. Beware of Outdated Agreements
Some parties have not updated their BAAs as changes to HIPAA occur. If, for example, a form agreement was originally drafted before 2013, it would not address the Health Information Technology for Economic and Clinical Health (HITECH) Act omnibus rule promulgated that year. That old agreement would be missing the amended definition of a breach and probably would not address the risks related to operations of parties in 2024. Furthermore, because OCR continues to promulgate new laws and regulations, BAAs and HIPAA policies and procedures can require frequent updating.
4. Make Sure Restrictive Agreements Aren't Too Restrictive
HIPAA does not restrict parties from including terms in their BAAs that fall outside of the items required under the regulation. Accordingly, it is prudent that business associates read the additional provisions carefully and ensure they are not overly restrictive. The permitted conduct section of the BAA limits the business associate's ability to use or disclose PHI for only the purposes allowed in the agreement; but if that section does not address conduct that is necessary for performing the services in the Service Agreement, the business associate may be too restricted and incapable of providing services to the covered entity without violating HIPAA. The terms of a BAA should be drafted carefully to ensure sufficient permissions for a business associate to perform services required under the contract.
5. Avoid Unrealistic Reporting Times
SUPPORT ISSUES?
Business associates may not immediately be aware of security incidents when they occur. Especially when the business associate works with independent contractors and parties outside its organization, the business associate has less control and insight into the occurrence of security incidents and breaches. But if the BAA requires notification within just a few days of the incident's occurrence, the business associate is more likely to be in breach of the BAA when it cannot timely report the incident to the covered entity. This impossible situation could be avoided if the business associate reads and negotiates the reporting time obligations in the BAA. Although it is understandable that reporting must occur relatively quickly so the covered entity can assess whether a breach has occurred, business associates can request reasonable timing for reporting incidents at the outset.
Importantly, HIPAA permits the addition of other terms that are not inconsistent with the regulation. Provisions addressing indemnification, injunctive relief, relationship to state privacy laws and other federal laws – such as Part 2 Privacy and Cures Act information blocking, along with other terms – may be included within the agreement. The terms of these agreements can make or break a party's privacy compliance program and should be treated as important topics of negotiation. Though this list is not exhaustive, it represents five of the biggest considerations for parties when entering into BAAs.
Shalyn Watkins, an associate in the Los Angeles office of Holland & Knight, is a graduate of the University of Alabama School of Law who is still licensed in Alabama and has practiced for a number of years in Birmingham.
Shalyn Watkins
Ascension St. Vincent’s Officially Becomes UAB St. Vincent’s
St. Vincent’s Birmingham
On November 1st, the University of Alabama at Birmingham Health System Authority has assumed ownership of Ascension St. Vincent’s Health System in central Alabama, which includes the hospitals at Birmingham, Blount, Chilton, East and St. Clair, as well as the One Nineteen Campus, the Trussville Freestanding Emergency Department, and imaging centers and other clinics that are part of Ascension Medical Group. The transaction includes Ascension St. Vincent’s ser-
vices, facilities, caregivers and associates, including a robust network of providers serving the region.
“We are thrilled to welcome St. Vincent’s patients, caregivers and associates to the UAB Medicine community,” said UAB Health System CEO Dawn Bulgarella.
UAB St. Vincent’s patients will continue to have access to the health care services and providers they’ve come to trust, and they will also gain access to a larger care network.
New Baldwin Addition Opens
At the end of October, South Baldwin Regional Medical Center opened a new 185,000-square-foot addition. The expansion which started in February 2023, includes a new five-story tower that features surgical facilities with a dedicated outpatient surgery center on the first floor, a women’s and children’s unit on the second floor, additional space for intensive care patients and more inpatient beds. The tower also provides more space for future growth.
The hospital has also been rebranded as Baldwin Health. “We’ve operated as a health care system for some time now, and we’re excited to move forward with a name that is reflective of our services and the communities we serve,” said Baldwin Health CEO Margaret Roley. The health system now
Joins MediSYS
has 25 locations throughout Baldwin County, including 10 new South Baldwin Medical Group locations that have opened over the last three years. The group employs more than 70 physicians.
Lauren Brown has joined MediSYS as a sales and marketing representative. She graduated from Troy University with a degree in Business Administration with a concentration in Marketing. While at Troy, she was a member of the Marketing Club and the Women in Business group. She is a member of the Healthcare Leaders Association of Alabama.
Lauren Brown
Brown
Margaret Roley, CEO of Baldwin Health
Another Rural Hospital in Alabama Faces Trouble SMA Celebrates Success of Its 116th Annual Scientific Assembly
On September 20, the nearly brandnew Thomasville Regional Medical Center closed its doors.
The hospital clarified the situation on Facebook: ““We were informed two weeks ago that cash was short. That has happened more than two dozen times over the last two years and the owners always found a way to close the gap. This time they didn’t. Our employees did not get paid on time last week and some of their checks bounced. They were also told by ownership on Friday there was a good chance they might not get paid on time next week. The ER doctors did
Welcome
not get paid this week either. The City Healthcare Authority offered a shortterm loan to assist TRMC until expected funds come in over the next couple of weeks to pay us back, but the authority insisted on a personal guarantee by the owner to pay them back.”
Thomasville Mayor Sheldon Day said that there are numerous entities interested in buying the medical center, and there are USDA loan guarantees that will help buy down accumulated debt after foreclosure. Day believes the facility will be attractive to potential suitors.
From October 24-26, 2024, the Southern Medical Association (SMA) hosted its 116th Annual Scientific Assembly in Atlanta. The event brought together professionals across various medical specialties, providing an opportunity for attendees to fulfill mandatory DEA requirements on opioids and substance use disorders, while engaging in discussions with expert faculty on topics ranging from finding joy in medicine to the impact of AI on clinician performance. Other key areas included sessions on hypertension and cardiovascular disease, professional boundaries, racial disparities in provider-patient communication, as well as palliative care, music therapy, and the environmental impact on patient care. In addition to these educational sessions, attendees had the chance to interact with exhibitors showcasing the latest in medical advancements.
"This year’s Assembly was a success, thanks to the dedication of everyone involved,” noted SMA Executive Director Randy Glick. “We are excited to build on this momentum as we look forward to next year in New Orleans.”
In addition to the educational ses-
sions, physicians-in-training had the chance to showcase their research as they presented oral and poster abstracts, competing for more than $9,000 in awards. Another Assembly highlight was the Third Annual SMA SMArt Bowl, a medical trivia contest featuring teams of medical students and residents competing for $5,000 in prize money.
The Assembly concluded with two celebratory events: SMA recognized outstanding medical students with more than $14,000 in scholarships in support of their educational journeys, and attendees gathered for the installation of Loretta Loftus, MD, MBA, as SMA’s 119th President.
Taylor Scruggs, M.D. Anesthesia & Pain Medicine Specialist
Dr. Taylor Scruggs is committed to delivering compassionate care and comprehensive treatments to help his patients find relief from chronic and acute pain. Board certified in both Anesthesiology and Pain Medicine, Dr. Scruggs brings a combination of in-depth medical training with a specialization in comprehensive pain management and pain relief interventions, such as epidurals, radiofrequency nerve ablations, spinal cord stimulators, and other nerve and joint injections. His goal is to get his patients back to doing the things that bring them joy and fulfillment.
Attendees attended sessions on a wide variety of topics.
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Molecular Designs Acquires Lamda Biotech
Birmingham-based Molecular Designs, a leading provider of PCR assays, associated reagents and equipment, has acquired Lamda Biotech, a provider of research products for application in molecular biology, functional genomics, proteomics and gene therapy. This partnership will enhance Molecular Designs' product portfolio, grow its reach into academic research and pharma market segments, and further expand its talent base of specialized personnel.
For more than 20 years, Lamda Bio-
tech has offered cutting-edge PCR products, RT-PCR reagents, RT-qPCR kits, Direct-PCR genotyping kits, DNA ladders, SafeStain, and other protein and cell biology products. Molecular Designs will leverage its manufacturing capabilities to scale Lamda's product offerings, enhance new product R&D, and increase access to customers through added distribution channels, which will solidify Molecular Designs' position as a key player in the molecular technology market.
Orlando Health and BBH Deal Completed
On October 1st, Orlando Health completed its purchase of the majority ownership of Brookwood Baptist Medical Center, Citizens Baptist, Princeton Baptist, Shelby Baptist and Walker Baptist.
“This is a great day for Brookwood Baptist Health and Orlando Health,” Thibaut van Marcke, senior vice president of Orlando Health, who’s slated to lead the Alabama region, said. “With our track
record of lifting the care at our partner hospitals, we are dedicated to making this healthcare system the best in the state and beyond.”
“We’re excited to have Orlando Health as a partner,” Amy Allen, CEO of Baptist Health System, said. “Their dedication to excellence has been recognized with national honors from leading quality and patient-safety organizations.”
Upstream Rehabilitation Names Mollica as
CEO
Anthony Mollica
Birmingham-based Upstream Rehabilitation, the largest dedicated outpatient physical therapy provider in the U.S., recently named Anthony Mollica as the company’s new CEO.
Prior to joining Upstream, Mollica was the CEO at Paragon Healthcare, a leading provider of infusion and pharmacy services. He has also served as president of hospice and palliative care with Amedisys, and had leadership roles with Brookdale Senior Living and Omnicare.
Upstream operates more than 1,200 outpatient rehabilitation clinics across 28 states, employing more than 8,000 people, with more than 7,400 of those team members dedicated to direct patient care. The company is on pace to realize nearly 8 million patient visits for 2024.
At Pulmonary Associates of the Southeast, we get your patients in sooner. Because sooner is better when someone is struggling with lung function, sleep, asthma, or other critical care conditions. That’s why we make referrals as easy as possible to get your patients in and on their way to feeling better.
Chemist with assay tray at Molecular Designs production facility in Birmingham.
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