Adrenal Surgery
By lAurA FreemAn
Sometimes the first sign of trouble is a set of labs that don’t make sense. Or it could be an incidental finding on a scan for something else. The radiologist spots a nodule where a nodule shouldn’t be.
“You may also be trying to find out why a patient with high blood pressure isn’t responding to any combination of medications you’ve prescribed,” Justin Malek, MD with Advanced Surgeons said. “As you rule out possibilities, you see the levels of adrenal hormones in the patient’s blood and then you have a pretty clear idea of what is going on.”
Whether a physician is dealing with an adrenal gland gone rogue and over-
Explaining the Options to Your Patient
producing, or a nodule that could be producing hormones or harboring a budding malignancy, it’s likely the patient will need a surgical consult for input to help decide what should happen next.
“While adrenal surgery isn’t as common as some other endocrine surgeries, it helps to refer the patient to someone who has done enough to be familiar with some of the more subtle factors,” Malek said. “There are several issues to consider. For example, although
Machine Learning Bypasses Need for Some Invasive Procedures
By JAne ehrhArdt
A new noninvasive diagnostic technology can quickly assess the likelihood of coronary artery disease (CAD) and pulmonary hypertension (PH) at the time of evaluation. Arriving first in Alabama at Cullman Internal Medicine, a 23-physician practice, the CorVista system utilizes machine learning to analyze
a patient’s cardiac signals, bypassing the need for invasive procedures to identify potential several cardiovascular issues at the point of care.
Cullman Internal Medicine has referred patients to the cardiologists at the Cullman Regional Medical Group Cardiology Clinic (CRMGCC). “We have now employed CorVista technology in our cardiology office, and also in the hos-
Cullman Internal Medicine First in State With CorVista
pital setting, to help us streamline diagnosis,” says Tracy Neal, MD, a cardiologist with CRMGCC.
In the two months since the clinic started using CorVista, they have already seen the device’s accuracy save a life. A
Justin Malek MD
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Ronald Orso, MD
5,000 babies delivered, 50 years of medicine and four military medals
By Ansley FrAnco
Ronald Orso, MD still recalls visiting his sister and her husband, who was a Tulane medical student, when he was 11 years old. As his brother-in-law made house calls to treat sick children in the city’s neighborhoods, Orso got his first glimpse of a doctor’s life. Celebrating 50 years of practicing medicine in Birmingham and central Alabama, that early spark of inspiration still drives him through his career.
During medical school, Orso initially planned to become a pediatrician — until the day he delivered his first baby. “The first time I delivered a baby, I realized that was what I wanted to do. It was so special, and it’s still special that it impressed me so much,” he said. “It was something that you could actually put your hands on and do. It was so rewarding to look at the faces of the mother and father.”
Over his 35-year career in obstetrics, Orso delivered nearly 5,000 babies. But in 2006, he shifted his focus solely to gynecology. Around the same time, a friend who owned an urgent care clinic asked him to help fill a temporary shortage of physicians. Orso agreed to work part-
Ronald Orso, M.D.
time until the clinic was fully staffed. 15 years later, he’s still there, providing care in urgent care alongside his gynecology practice.
“The thing that attracts me to it is that I get to do things I don’t normally see,” Orso said. “To work in urgent care you have to take courses and get current on treating ear, nose and throat problems, orthopedic problems, reading chest
X-rays and reading EKGs. So it involved about a six-month period of really intensive study to get boned up on that.”
Since beginning his career in obstetrics and gynecology in 1975, Orso has witnessed significant changes not only in his field, but in medicine as a whole. Advancements in technology like ultrasounds, MRIs, PET and CAT scans, have revolutionized modern healthcare, giving healthcare professionals the ability to see inside the human body in ways that weren’t possible when Orso was in medical school.
“I believe that physicians that have been in medicine as long as I have, we all recognize how much it’s changed and how so important it is for us to have a lot of continuing medical education,” Orso said. “You have to stay up, you have to do courses. I do a lot of mine online, but there are also continuing medical education courses everywhere.”
While balancing his medical practice, staying current with advancements in healthcare technology and raising a family, Orso also served as an active colonel in the Alabama Army National Guard from 1972 to 2005. He joined the Guard after graduating from medical school. “I
joined initially because I didn’t want to be drafted before finishing my residency, and then it became apparent to me that I really loved what I was doing,” he said. “And so when the six years were up and it was time for us to get out, I wanted to stay in.”
In the National Guard, Orso was able to intersect with the community on a number of occasions — running clinics for people with no insurance in southern Alabama and setting up a triage unit when a tornado hit Birmingham in 1998. He also served in Operation Desert Shield and Desert Storm for about six months. His service led to four medals. The most recent was the State of Alabama Distinguished Service Medal in 2006. “Those honors mean a lot to me,” Orso said. “I just love what I did. I love the military, and I love the fact that I was able to participate in Operation Desert Storm, Desert Shield, and we did a good job in taking care of folks.”
Orso is no stranger to recognition. In 2017, he was named one of b-Metro Magazine’s Top Doctors. “It was an honor to be named. It motivated me to continue to be the best doctor I could be,
I usually prefer an abdominal approach using a laparoscope and the DaVinci robot, if the patient has had previous abdominal surgeries, I may consider a more direct approach through the back. It’s a shorter route without the need to move as many organs out of the way, but I know if I cut those particular muscles, the patient may be dealing with back pain that can take a while to heal.
“If there are other factors, a lateral approach is also possible. We don’t usually use open surgery anymore unless there is a strong indication of a malignancy that may have spread, or if an unusual anatomy makes it difficult to visualize both adrenal glands and the surrounding structures.”
When patients hear adrenal disease, they may think about Addison’s, which is treated with medication. However, other adrenal disorders are more typically are treated surgically.
“Cushing’s syndrome, if it is mild, can be managed for a while with medication, but when it becomes severe, surgery may be the best option,” Malek said. “With Cushing’s, there are visible clues and symptoms that help identify the disorder: abdominal weight gain, a fatty lump between the shoulders, fatigue and a dulling of mental acuity. You might also see purple stretch marks on the stomach, hips, thighs, breasts and underarms.”
Cushing’s is caused from having too much cortisol in the body. This can result from a person taking glucocorticoid medicines like Prednisone in which case the
provider may try lowering the medication. However, when it results from an adrenal gland that is overproducing cortisol, physicians will perform an adrenalectomy to remove the malfunctioning gland.
In order the ensure that they are removing the right adrenal gland, during surgery Malek’s team can take samples of blood from the veins exiting the adrenals and measure the hormone levels in each one. “Usually the sample taken near the adrenal at fault is noticeably higher,” Malek said. “Only if the patient has only one gland or the health of the other adrenal is questionable would I be likely to try to preserve some of the gland that is malfunctioning.
“Sometimes the excess hormone is coming from a nodule. After we remove the nodule, we test it, and if it tests positive for malignancy, we look closely at the other adrenal and nearby organs including the pancreas. The cancer may originate in an adrenal or adrenal nodule, or it could have spread from the liver or another organ. When malignant cells are found, we bring an oncologist onboard to manage follow-up care.
“If no malignant cells are identified, after laparoscopic surgery patients can go home either the same day or the next day, depending on whether we need to monitor blood pressure changes from shifting hormones.
“Adrenal surgery can be rewarding for me because we’re able to outright cure serious disorders with a minimally invasive procedure in a single day.”
Cullman Internal Medicine First in State With CorVista,
72-year-old patient had been evaluated for atypical chest pain and underwent an evaluation by a cardiologist and a nuclear stress test. The stress test came back normal. However, the patient’s symptoms continued.
“So we ran the CorVista test on this man and it was abnormal, indicating the possibility that we had missed something,” Neal says. “We performed a heart catheterization and found a 99 percent blockage in the main artery down the front of the heart. That’s called a Widow Maker blockage. CorVista was able to pick up a heart problem that we had previously missed and saved the man’s life.”
Currently, the CorVista System holds FDA approval to detect the likelihood of coronary artery disease (CAD) and pulmonary hypertension (PH). The company is currently seeking approval for identifying pulmonary capillary wedge pressure.
The system works similar to an EKG. “Whenever the heart beats, it gives off millions of electrical signals, but it also emits millions of other physiologic signals such as impedances, which are resistances within the way electricity flows,” Neal says. “And the heart has a normal movement and a normal vibration.”
The device’s seven sensors attach to the patient to collect specific electrical and physiologic data signals. The information arrives at the handheld device, about the size of an iPad, and the physician sends it along to CorVista’s cloud
continued from page 1
system where advanced machine learning interprets the results in comparison to data from 11,000 cardiac patients who had undergone catheterization. Then it sends a report back to the handheld device. The whole process takes about 15 minutes.
“It’s a binary result,” Neal says. “It’s either positive for the condition or negative for the condition. No test is completely accurate, but this test has an 88 percent sensitivity for determining whether someone has severe significant blockage or not. It also has a 99 percent negative predictive value for determining if someone does not have heart disease, which means that if the test says the heart is okay, there’s a 99 percent chance that the heart is indeed okay.”
Practices do not buy the system or pay a subscription. Instead, the company provides the device, and they collect the insurance fee for reading the test, while the physician bills insurance for administering the test.
“It’s another good tool to help us streamline cardiac diagnosis, and it helps us look at a larger number of patients in a much more rapid fashion,” Neal says. “For primary care clinics, the system provides a valid evaluation on who needs to get in to see the cardiologist quicker. And it gives the practice a proven test to back up that request. We don’t pay anything at all, so it was a no-brainer for us to incorporate it.”
Ronald Orso, MD,
continued from page 3
to keep up with modern medicine and to certainly be more attentive to my patients’ needs,” he said.
After 50 years of practicing medicine, Orso says he’s at the point where he needs to slow down a little instead of speeding up, and traveling is on he and his wife’s list of to-do’s. “As a physician, you always say, ‘later on, we’re going to travel.’ And so those years passed by, and my wife and I realized that we haven’t traveled to a lot of the places that we wanted to see,” he said.
Throughout his career, Orso often told his wife that he genuinely enjoys going to work every day. He encourages young physicians to do the same by choosing a field they are truly passionate
“I feel sorry for those physicians and everybody else who dread getting up and going to work. I don’t know how they do it. It’s hard enough when you love what you do,” Orso said. “So I think the main thing for young physicians is they should choose something that they really love to do before they sign on the bottom line for a residency.”
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5 Things to Consider When Negotiating Business Associate Agreements
By shAlyn WAtkins hollAnd & knight
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.
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.
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 parties. 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.
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.
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
Moving Birmingham Forward.
Shalyn Watkins
Is An Untreated Sleep Disorder Putting Your Patient At Risk?
By lAurA FreemAn
It doesn’t take years for a sleep disorder to kill. Aside from its lethal effects on heart disease, stroke, hypertension and other chronic killers, the death it brings isn’t always gradual. It can happen in an instant, when a moment of sleepy inattention on a work site turns into tragedy, or when a drowsy driver drifts into oncoming traffic.
“Sleep is fundamental to health and a major influence on the course diseases will take,” UAB Sleep Lab director Patricia Patterson, MD said. “In addition to arrhythmias and heart failure, there is an association with metabolic disorders including diabetes and obesity. Some research also suggests a disturbance in immune response when sleep disorders remain untreated.”
Although suspicion of sleep apnea is the most common reason physicians refer patients to the sleep lab, the range of sleep disturbances is broad.
“Insomnia is common these days,” Patterson said. “Sometimes it’s related to short-term stress. Disturbances in circadian rhythm, like working a night shift, can also be factors. Or it could be a mat-
ter of sleep hygiene, in which case it can be improved by cutting back on caffeine late in the day, increasing morning light, and avoiding blue light before bedtime. However, long-term insomnia may have neurological aspects.”
Restless legs, sleep walking and other movement disorders also put patients at risk and warrant investigation. Problems such as night terrors can have both sleep and psychological or neurological components and may need a multidisciplinary approach to resolve.
“Sleep apnea usually presents with symptoms like persistent fatigue even on waking, frequent urination, difficulty with
concentration, irritability, daytime sleepiness and possibly an irritated throat,” Patterson said. “Most sleep apnea patients are likely to be overweight and older. Obesity is a chicken and egg situation. Losing weight can reduce the severity of apnea, but apnea is associated with higher levels of hunger hormones, lower levels of satiety hormones, and fatigue that reduces activity, all of which makes losing weight harder. However, the good news is that the reverse is also true. Treating apnea can help make those stubborn pounds easier to lose.”
The gold standard of care for obstructive sleep apnea is positive air
pressure therapy (PAP), which may be prescribed in the form of CPAP, biPAP or automatic APAP, depending on breathing patterns.
“The air pressure acts like a stent to keep the airways open,” Patterson said. “We prescribe a range of pressure levels depending on the severity of the disorder. Most PAP equipment can be set at low pressure and gradually be ramped up as the patient falls asleep. It can be at full prescribed pressure during deep sleep when muscles relax and airways are more likely to collapse. Instead of patients having to repeatedly come near wakefulness to breathe, the pressure protects the airway and they continue in deep sleep.
“During sleep studies, we connect electrodes to monitor brain activity and sensors to follow the heartbeat and breathing. This gives us plenty of data for a clearer picture of what is happening. Apnea is measured in events per hour, which means the number of times breathing either stops, is delayed or becomes too shallow to supply enough air. If there are more than five events per hour, the patient may need treatment.
“There are other possible interven-
PRESENTING
A concise and relevant review of the past year’s developments and recommendations for the prevention and treatment of cardiovascular disease.
• Atrial Fibrillation and Anticoagulation | Chad Colon, MD
• Sudden Cardiac Death in Athletes | Scott Kirby, MD
• Ventricular Arrhythmias for Primary Care | Sarah Sandberg, MD
• SGLT-2 Inhibitors | Wytch Rigger, MD
• Lipid Management: Beyond Statins | Saema Mirza, MD, FACC
• Peripheral Vascular Disease | Jan Skowronski, MD, MBA
• Resistant Hypertension | Andrew P. Miller, MD, FACC
• Aortic Aneurysm | Edward Ferguson, MD
• Cardiac Protection in Diabetics | John T. Eagan, Jr., MD, FACC
• Hypertrophic Cardiomyopathy | Matthew Sample, MD, FACC
• Low Flow, Low Gradient Aortic Stenosis | Stephen Bakir, MD, FACC
• Diagnostic Approach to Coronary Artery Disease | Saji C. Jacob, MD, FACC
Patricia Patterson, MD
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5 Things to Consider When Negotiating Business Associate Agreements,
continued from page 6
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.
Avoid Unrealistic Reporting Times
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.
ChristopherS.Carter,MDEmilyBellCasey,MD
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.
Untreated Sleep Disorder Patient At Risk,
continued from page 7
tions, including raising the head of the bed or stacking pillows in a wedge to allow more upright sleep. We might also teach patients to sleep on their side rather than their back, and may include a side sleeper pillow to support the neck.”
There are also oral devices and chin straps to maintain a better airway position and prevent the jaw from dropping and the tongue from falling back. If unusually large tonsils, nasal polyps or other obstructions are found, the patient may be referred for a surgical consult.
it,” Patterson said. “Even if patients are unable to continue PAP therapy, there is always something we can do. For example, we now have an implantable device that stimulates the tongue during sleep so it doesn’t fall back and block the airway.
ChristopherM.Beaumont,MDAndrewM.Cordover, BentonA.Emblom,MDJamesA.Flanagan,Jr.,MDWayneMcGough,
“We like to get patients setup with a Bluetooth app that offers coaching to help them resolve common issues and stick with
ChristopherM.Beaumont,MDAndrewM.Cordover,MDJeffreyC.Davis,MD
The FDA has also just approved the Eli Lilly weight loss drug Zepbound (R ) (tirzepatide) to treat moderate to severe sleep apnea. The weekly injectable is the first medication approved to treat the disorder. In placebo controlled trials, subjects lost an average of 20 percent of their body weight. Negative breathing events were reduced by 29 per hour in patients also using
(CONTINUED ON PAGE 10)
Welcome Or. Pitts!
CharlesC.Pitts,Jr.,MDMarcusA.Rothermich,MDNormanE.Waldrop,Ill,MD
BentonA.Emblom,MDJamesA.Flanagan,Jr.,MDWayneMcGough,Jr.,MDKathleenE.McKeon,MDK.DavidMoore,
Christopher Monte
Christopher
Untreated Sleep Disorder Patient At Risk?,
CPAP therapy and 25 per hour in patients using the medication alone.
What Doctors Can Do
Getting PAP Ready
Helping patients identify related health issues and resolve them can greatly improve the odds for success.
“If patients have chronic sinus congestion, allergies, reflux or other problems that impact their breathing, resolving them can open up a wider choice of equipment options. Being able to use a nasal pillow mask rather than a full face mask could be easier for patients with beards, sensitive skin, unusual facial structure or claustrophobia. They can also use the oral devices to help with nose breathing and avoid a dry throat from a mouth that falls open,” Patterson said.
“When muscle aches, joint and back
pain or stress and anxiety make sleeping more difficult, dealing with them makes it easier to fall asleep rather than lying there hurting and frustrated.”
Knowing What To Expect
Unless patients have experience with an issue like insulin-dependent diabetes, they may be surprised by how much their success in the early weeks depends on their own daily efforts to get to know their equipment and how to use and maintain it.
“It’s very much a learning process where patients learn by doing. Facial structure and their particular combination of health issues are unique to each person. Using PAP consistently every night is how they identify what works for them, what needs to be better, and where to go for suggestions on different aspects of customizing the therapy so it works for them.
continued from page 9
“Like learning to ride a bike or play the piano, practice and persistence help. Making your therapy fit you is also like having a suit custom tailored. You can start with a great design, but it’s the custom touches, one by one, as you make small adjustments to fit your body that make the difference.
“It takes a daily effort, but the rewards are worth it. As you sleep better and your health improves, you’re going to feel so much better.”
Help Patients Understand What’s At Stake And Why They Shouldn’t Give Up.
Unsupported, failure rates can be high. But understanding why they are investing the effort can help patients stay motivated when challenges come.
As one patient put it, “There are times in the early morning when I can’t
stop the whoopee cushion air leaks or can’t find a comfortable position and I could gladly toss my mask out the nearest window. What keeps me coming back every night to try again is knowing I don’t want dementia or to put my family at risk in a wreck, or for my grade three kidney disease to progress to grade four and become dialysis dependent. That would be a lot more confining than a mask. So every night, I’m back trying again and gradually learning what works for me.”
Tips From PAP Patients
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“Be good to yourself. Refill your humidity chamber every morning or when you first get home so you don’t have to do it when you’re sleepy. Instead of struggling with a gallon of distilled water, every week when you clean your machine, fill seven bottles with a premeasured amount. Filling to slightly below the mark on the chamber usually works best. Mine is easier if I turn the chamber on the side and mark a fill line with a permanent marker.”
“Set up a comforts kit in a basket or bin by the bed, and designate a place for each item so you can find it in the dark. Check to make sure there is plenty of everything when you reset your humidity chamber. You don’t want to find you’re out of tissue, saline nose spray or dry eye ointment when you need it.”
“Check YouTube for manufacturer videos, reviews and tutorials on your specific equipment. That’s how you learn about features you didn’t realize were there and get ideas on what to do if something new comes up. Also check the comments posted. You’ll find great ideas from other users. Just remember every face is different. The perfect mask for one guy may be wrong for someone else
“To get sleep study electrode glue out of your hair, mix half dishwashing liquid and half deep conditioner plus a few drops of warm water. Massage it in, cover with a steaming towel for a few minutes, then double shampoo and follow with a conditioning treatment.”
“If your machine has a seal test setting, try it lying on your side. As the pressure ramps up, you’ll get a better sense of whether the straps need to be adjusted.”
“If you wake up feeling you can’t breathe, the pressure may be keeping you from breathing out enough so you can breathe in. Try pursing your lips and blowing, then take a deep breath. Try to resist the impulse to tear your mask off or you may have to put it back together again in the dark.”
“Try your mask in daylight. Memorize how the straps fit together, and look for touch landmarks so you can put it back together again in the dark. Also learn how to reconnect the plastic nose piece and silicone pillow if it pops out. You don’t want to be stranded wondering what to do if you have a light sensitive
(CONTINUED ON PAGE 17)
By Jami Vibbert, Nancy L. Perkins, Jason T.
A MANIFESTO
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.
Pain management clinic fined $1.19 million for alleged HIPAA security rule violations
OUR ENEMY:
By Todd Shryock
Raylesberg | 12/16/24 | arnoldporter.com
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.
| 11/15/24 | medicaleconomics.com
Ransomware surge highlights critical cybersecurity gaps in health care
By Jonathan Ishee & Michael Paluzzi
WHO/WHAT ARE WE FOR:
| 12/17/24 | jdsupra.com
Congress considers new cybersecurity legislation adjunct to HIPAA
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.
The Future of False Claims Act
Qui Tam Provisions
By: roBin B. mArk
On September 30, 2024, a federal district court in the Middle District of Florida dismissed a qui tam action under the False Claims Act (“FCA”) on the basis that the FCA’s qui tam provision – which allowed individuals to sue on behalf of the government – is unconstitutional. U.S. ex rel. Zafirov v. Florida Medical Associates LLC, is the first case in which a court has held the FCA’s qui tam provision unconstitutional and it carries significant implications for the future of FCA litigation.
The FCA permits any private party, known as whistleblowers or relators, to enforce the statute by filing a lawsuit in the name of the federal government. See 31 U.S.C. § 3730(b)(1). Successful relators may receive a portion of the proceeds recovered, ranging from 15 to 30%. Id. at 3730(d). This incentivizes private parties and their lawyers to file qui tam actions. The vast majority of FCA actions are initiated by private parties rather than government initiated FCA cases. In a February 2024 press release, the Department of Justice reported that “[w]histleblowers filed 712 qui tam suits
in fiscal year 2023, and this past year the Justice Department reported settlements and judgments exceeding $2.3 billion in these and earlier-filed suits.”
In Zafirov, a whistleblower physician filed a qui tam action against her employer, among others, asserting that Florida Medical Associates intentionally misrepresented patient medical conditions to Medicare, resulting in unnecessary medical services. The government declined to intervene. After years of litigation, the district court opined that relators filing lawsuits on behalf of the government operate as “Officers” of the United
States executive branch, which requires an appointment under Article II of the U.S. Constitution. Article II requires the president, a court, or the head of a federal department to appoint “Officers of the United States.” The court found that relators in FCA cases enjoyed “unfettered discretion to decide whom to investigate, whom to charge in the complaint, which claims to pursue and which legal theories to employ.”
U.S. ex rel. Zafirov v. Florida Medical Associates LLC, 2024 WL 4349242, at *2 (M.D. Fla. Sept. 30, 2024).
The Zafirov case will most likely be appealed to the United States Court of Appeals for the 11th Circuit and will likely be reconciled with a recent Supreme Court holding in U.S. ex rel. Polansky v. Executive Health Resources, Inc., where the Supreme Court described the relator’s control of a qui tam suit as being significantly more limited. Supreme Court Justice Clarence Thomas wrote in his 2023 dissent in Polansky, “the [False Claims Act’s] qui tam provisions have long inhabited something of a constitutional twilight zone.” Justice Thomas pointed out that there are “substantial arguments that the qui tam device
is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.”
The Court in Zafirov has now stepped into the “twilight zone.” Should the Zafirov defendants prevail on appeal and create a split among the circuit courts, the United States Supreme Court will likely be called upon to resolve the constitutionality of the FCA’s qui tam provision, a decision that could change the landscape of enforcement actions nationwide. For the time being, at least one court has held that qui tam whistleblowers are unconstitutional.
Key Takeaways
• The Zafirov decision could signal challenges for future FCA relators, as it calls into question their standing to pursue claims on behalf of the government. If the government elects not to intervene in a qui tam, litigants should consider pursuing dismissal of the relators complaint based upon a Constitutional challenge to the Appointments Clause.
• Whether the Zafirov decision will prevail is still uncertain as the government will
(CONTINUED ON PAGE 17)
Robin B. Mark
Glaucoma Gains in VR and Lasers
By JAne ehrhArdt
Gaming has led to a new diagnostic tool for glaucoma. What normally has required a $35,000 to $50,000 machine to measure peripheral vision can now be done with a $10,000 piece of headgear. “We’re starting to use virtual-reality headsets,” says ophthalmologist Lindsay Rhodes, MD, MSPH, with TriaVision. “It just takes a few minutes to check patients’ peripheral vision.”
For decades, the gold standard for measuring peripheral vision, where glaucoma strikes first, has been administered through a bulky desktop device. As the patient stares straight ahead with her head kept stationary in a chin support, it tests one eye at a time with flashes of light that go off in various areas of her peripheral vision. The patient presses a button each time she thinks she sees a light.
Called perimetry, the mapping of the peripheral threshold tests the functional behavior of the optic nerve to help determine the extent of glaucoma, along with some neurological and retinal diseases. “In the last five years, there has been a huge increase in companies trying to create these virtual reality headsets and goggles,” says Rhodes, who holds a fellowship in glaucoma.
The devices use the familiar gaming
VR equipment, but are loaded with the perimetry software.
The process is shorter, and the freedom of movement with the headset alleviates common physical problems for older or obese patients, or those with neck or back conditions, or mobility issues.
ting glaucoma. “The biggest thing about glaucoma is that it’s often diagnosed late and when that happens, you can’t undo the damage or recover the vision that’s been lost,” Rhodes says.
“With the old equipment, some people would fall asleep, because the test is long and boring,” Rhodes says. “But it only takes a few minutes to check their peripheral vision using the new headset. With the ease, speed, and affordability provided by VR, optometrists are now performing perimetry tests. I could see a primary care office wanting to get these.”
Screening by primary care physicians could be a game-changer for spot-
Because it’s such a slow disease, patients rarely notice any problem with their vision until late in the disease course. That means questioning patients about their vision during routine exams by primary care physicians is unlikely to uncover potential glaucoma.
“The best thing primary care physicians can do is to ask their patient about the family history of eye diseases and glaucoma specifically,” Rhodes says. “Because if there’s a direct relative who has it, that increases the risk of glaucoma by four to nine times. People of African, Hispanic, or Asian descent all have six to eight times higher risk of glaucoma than Caucasians.
“Anyone over 60 of any race runs a six-time higher risk of harboring the disease as well. Most of the diseases of the eye are diseases of aging—cataracts,
macular degeneration, glaucoma. So if your patient is 60 or older, I recommend they get an eye exam.”
The goggles do hold some limitations. There isn’t much long-term data on how well they perform in various stages of glaucoma. For early detection screening, the VR system works well, but has yet to prove itself in the more sensitive monitoring of people with severe glaucoma.
Treatments for glaucoma have also taken a new leap. “There have been some awesome five-year studies on the longterm effects of laser for glaucoma, and those are really exciting,” Rhodes says.
While daily eye drops to lower the fluid pressure in the eye have been the first line of long-term treatment for glaucoma, in recent studies the laser has been shown to outperform eye drops over a longer period. Laser procedures adjust the flow or production of fluid in the eye by changing the architecture of the drainage system, or trabecular meshwork, to maintain a consistent healthy pressure.
“There are also new procedures called minimally invasive glaucoma surgeries,” Rhodes says. “The various new options in diagnosing and treatment are particularly needed with glaucoma. There are little nuances with each person’s glaucoma. Every case is just totally different. That’s the art of treating glaucoma.”
Lindsay Rhodes, MD
Emerging Research Shows Myofunctional Therapy can Improve Conditions Beyond Speech Issues
By lAuren Johnston
Through myofunctional therapy, speech therapists are seeing improvements in patients with a number of issues, including sleep apnea, reductions in orthodontic relapse, an increase in airway health, and improved speech and feeding skills. Emerging research is showing the correlation between speech sound disorders and myofunctional disorders.
“There’s one study that focused on kids who had enlarged tonsils,” said Lauren Hughes, CCC-SLP, the owner of Expressions Pediatric Therapy in Birmingham. “One group had palate expansion before they were to have their tonsils removed, and the other group had their tonsils removed before they had palate expansion. There were significantly more kids in the first group that didn’t need their tonsils taken out because their airway had widened enough so they could nasal breathe. It helped the tonsils reduce, and they weren’t inflamed anymore.”
While speech sound disorders involve pronunciation of different sounds,
myofunctional disorders involve the functions of the tongue, face and mouth.
“Myofunctional therapy has been around in some iteration for over 100 years,” Hughes said. “It started in the orthodontic community, and they realized that the function of the muscles of the face affected the structure of the teeth and the palate. Then speech therapists brought it in around the 1960s to provide therapy.”
Utilizing this form of therapy, speech therapists can help patients retrain the muscles of their tongue, face and mouth to work properly. This is done by address-
ing issues like tongue posture, breathing and swallowing. The exercises are individualized to each patient and range from foundational skills to more refined skills.
“One of the key components of myofunctional therapy is teaching the mouth to rest correctly,” Hughes said. “Your tongue should be lightly suctioned to the roof of your mouth. Your lips should be lightly closed, but not pressing hard. Your teeth should be a few millimeters apart.”
Hughes, who specializes in orofacial myology, motor-based speech and feeding disorders, partners with ENTs, orthodontists and physical therapists to treat patients holistically. Myofunctional therapy often starts with training the mouth to rest correctly and pinpointing any structural airway issues, which may require a referral to an ENT.
The next step involves identifying any other issues or weaknesses with the jaw, lips, face or tongue. Hughes will work on strengthening the muscles in the mouth. She might also work with dissociation issues, which refer to a lack of coordinated movement between the tongue, lips, and jaw, meaning the muscles in-
volved in these functions are not working independently as they should.
“Once we get that going, we can see some improvement even in attention and focus,” she said. “There is true neurological ADHD, but sleep disordered breathing can also look like ADHD. There has been research to show that if it is caused by sleep disordered breathing, we can improve some of those symptoms.”
For adults, Hughes has seen success in patients with TMJ facial pain, improved quality of sleep, and better tolerance of sleep appliances, like a CPAP machine.
When the palate isn’t wide enough, myofunctional therapy can improve dental crowding and shift teeth in younger children. Patients with speech and feeding issues also benefit from myofunctional therapy. By implementing this therapy first, children struggling with speech issues improve faster. They will often need less speech sound therapy or sometimes none at all after undergoing myofunctional therapy and oral motor strategies. Children struggling with feeding issues, like chewing hard food, often see improvement within one to two months.
Lauren Hughes, CCC-SLP
Untreated Sleep Disorder Patient
At Risk,
continued from page 10
bedmate.”
“Moisturize in the morning, not at night. Or if you must, wipe the skin surface where it meets the mask. If it’s giving you rude leak sounds, wipe the silicone pillow, too.”
“Since I started CPAP, I don’t have to go to the bathroom as often. But it has been helpful once a night to turn off the mask, go to the bathroom, get a sip of something to drink, use the saline nose spray, then reposition the mask and turn on the machine, letting it gradually ramp up to pressure as I go back to sleep.”
“Keep a notebook and pen by the bed. If you get congested, write what you ate or what allergens you might have come into contact with the day before. If you have had problems, try to write a simple description while you remember. Examples--“Upper left strap rubbing felt tight on cheek,” or “Lower right seal leaking when I roll over to the other side.” Having a starting point for troubleshooting helps you swat the little aggravations so they don’t continue to bother you.”
“If you’re having trouble getting to sleep, don’t just lay there waiting or every itch, twitch and circular thought will drive you to frustration. I set up playlists of audiobook, soft music and podcasts that are interesting enough to be distracting but boring enough to let me fall asleep. YouTube lets you set up playlists by topic, but listen—don’t look at the blue light. I’m learning a lot about archeology and astronomy. If you’re stuck without a playlist, remember your favorite places and relive vacations. Remembering and imagining are so close to dreaming.”
The Future of False Claims,
continued from page 7
appeal, but there is reason to anticipate that Zafirov may become the law of the land as several U.S. Supreme Court Justices have expressed concerns about the constitutionality of qui tam provisions of the FCA.
• If relators are ultimately limited in their ability to pursue qui tam cases, the burden will fall on the government to handle more fraud cases, which could reduce the overall number of FCA enforcement cases that the government has the resources to pursue and compromise the government’s ability to recover through qui tam cases.
Robin B. Mark is a partner at Burr & Forman LLP. She focuses her practice on the representation of individuals and corporations facing government enforcement actions. She assists clients with conducting internal investigations, navigating their potential civil and criminal exposure and responding to law enforcement inquires. Robin may be reached at rmark@burr.com or (205) 458-5473.
Study Reveals a Potential New Treatment Option for People with Hidradenitis Suppurativa
Hidradenitis suppurativa, (HS) is a condition that causes chronic inflammation on the surface of the skin. It’s characterized by painful bumps that form under the skin and can sometimes rupture.
In a study published in Proceedings of the National Academy of Sciences, UAB Department of Dermatology professors Chander Raman, PhD and Mohammad Athar, PhD revealed that by disrupting the protein CD2’s interaction with CD58, the gene expressions that result in HS symptoms could be suppressed, resulting in potential novel treatment options for HS.
Current treatments for HS mainly reduce some symptoms, but they don’t cure or arrest the progression of the disease.
The Raman and Athar team’s study uncovered that the lymphocyte cell surface protein CD2 is expressed at elevated
levels on T lymphocytes and innate lymphocytes, including natural killer cells (NK), natural killer T cells (NKT) and mucosalassociated invariant T cells (MAIT) in HS lesions. The understanding that innate lymphocyte populations, specifically NKT cells and natural killer cells, express high levels of CD2 and are the predominant lymphocyte population in HS lesions helped
demonstrate that the blockade of cognate interaction between CD2 and CD58 had profound effects in mitigating gene expression and secretion of proteins (cytokines, chemokines, growth factors) that are relevant to the pathogenesis of HS.
“Our study identifies CD2:CD58 interaction along with NKT and NK cells as major drivers of HS pathogenesis,” Raman said. “Targeting of CD2:CD58 therapeutically offers an opportunity to treat HS, an incurable debilitating skin disease impacting quality of life among young patients, particularly women.”
According to the HS Foundation, HS impacts about one percent to two percent of people, particularly between the age group of 16 to 40, in the United States. The disease commonly affects women of African American descent.
Research Finds a Low-Carb Diet may Improve Beta-Cell Function in Type 2 Diabetes Patients
Could Potentially Eliminate Need for Medication
New research from UAB, published in the Journal of Clinical Endocrinology & Metabolism, shows that adults with Type 2 diabetes who follow a low-carbohydrate diet might experience improvements in their beta-cell function, potentially helping them manage their condition more effectively and possibly allowing them to reduce or eliminate the need for medication.
More than 38 million Americans have diabetes, and more than 90 percent of them have Type 2 diabetes. Type 2 diabetes usually presents in people who are 45 or older. However, it is becoming more common in children, teenagers and young adults too.
People with Type 2 diabetes have a compromised beta-cell response to blood sugar, possibly due in part to eating too many carbohydrates. Beta-cell failure or
insufficiency on top of insulin resistance is responsible for the development and progression of Type 2 diabetes.
The study compared two groups of adults with Type 2 diabetes: one group followed a lowcarb diet, and the other followed a high-carb diet. Participants were asked to stop taking their diabetes medication before the study started so any changes in their health could be linked to the diet. All participants were given their meals. The study found that the low-carb diet improved beta-cell function and insulin secretion, even after accounting for any weight loss.
The researchers found those on a lowcarbohydrate versus a high-carbohydrate diet saw improvements in the acute and
maximal beta-cell responses that were twofold and 22 percent greater, respectively. Within each race group, Black adults on a low-carbohydrate diet saw 110 percent greater improvements in the acute beta-cell response and White adults had improvements in the maximal beta-cell response that were 48 percent greater than their respective counterparts on the high-carbohydrate diet.
“Further research is needed to determine if a low-carbohydrate diet can restore beta-cell function and lead to remission in people with Type 2 diabetes,” said lead study author Barbara Gower, PhD, chair of the UAB Department of Nutrition Sciences.
Chander Raman, PhD Mohammad Athar, PhD
Barbara Gower, PhD
Preparations Made to Launch Healthcare Boarding School
In December, the board overseeing the creation of Alabama’s first residential high school focused on healthcare met to prepare the curriculum. The Alabama School of Healthcare Sciences, located in Demopolis, is scheduled to enroll its inaugural ninth-grade class in 2026.
The school aims to address Alabama’s healthcare staffing crisis, particularly in rural parts of the state, by training students for roles across the medical field. The course work will include partnerships with community colleges and regional hospitals where students can get clinical hours. The
school will offer certification levels beyond what’s currently available in Alabama high schools for students looking to become healthcare professionals.
Bloomberg Philanthropies’ initiative to establish high schools focused on health care is providing $26 million of the estimated $80 million needed to build the dormitory and campus facilities with a groundbreaking expected by mid-2025. The five-story dorm will be the tallest building in Demopolis. Pearson said that the school is the only rural residential school funded by Bloomberg.
Two UAB Professors Named National Academy of Inventors Fellows
Two UAB Marnix E. Heersink School of Medicine faculty members, Michael Niederweis, PhD, a professor in the Department of Microbiology, and Cynthia Owsley, PhD, a professor in the Department of Ophthalmology and Visual Sciences, have been named fellows of the National Academy of Inventors (NAI) for their innovation in creating inventions that have made an impact. This is the first time in over a decade that this distinction was awarded to two UAB faculty in the same year.
Niederweis, who holds 12 patents, discovered the channel protein MspA,
which can be modified to sequence DNA quickly and inexpensively. His technique received Method of the Year 2022 by Nature Methods. Owsley, who holds 11 U.S. patents, invented a dark adaptometer, an apparatus that detects impaired dark adaptation, commonly used in the study of age-related muscular degeneration.
The NAI is comprised of U.S. and international universities, along with governmental and nonprofit research institutes. It has 4,000 members and spans more than 250 institutions worldwide.
MediSYS January Webinars
MediSYS is hosting several webinars in January.
Nita Limdi, PharmD, PhD, MSPH, FAHA, has been named Associate Dean for Genomic Medicine at UAB. She assumes this role after the retirement of Bruce Korf, MD, PhD.
Limdi earned a Bachelor of Science in Pharmacy from A.R. Patel College of Pharmacy in India in 1987 and a Doctor of Pharmacy from Samford University in 1994. Observing the variability in anticoagulant response among African Americans sparked her interest in clinical research, and she continued to develop research skills, completing an MSPH in 2005 and a PhD in Epidemiology in 2008.
She holds the Ray L. Watts Heersink Endowed Chair in the Department of Neurology. She also serves as Director of the Translational Pharmacogenetics program at UAB, Codirector of the Center for Clinical and Translational Science, and Associate Director of the Hugh Kaul Precision Medicine Institute.
Limdi has mentored over 40 postdoctoral trainees and junior faculty since 2001. She was awarded the UAB
Dean’s Mentorship award, a mentorship grant from NIH, and was nominated to serve as the Director of the UAB CTSA Training Academy for the UAB Center for Clinical and Translational Science.
January 21 from 12:00 pm to 12:30 pm CST: New Features. Learn about the tools and features within MediSYS to enhance productivity while saving time and money.
January 28 from 12:00 pm to 12:30 pm CST: Kim Huey discusses coding changes for 2025. She is an experienced independent coder
and reimbursement consultant with expertise in auditing, training, and oversight across various medical specialties.
To register, visit www.medisysinc.com/events and on the calendar, click on the webinar.
Breast Cancer Research Foundation of Alabama Made $1,125,000 in 2024 Grants
The Breast Cancer Research Foundation of Alabama (BCRFA) has made $1,125,000 in grants in 2024 to support 22 breast cancer research projects throughout the state. The beneficiaries are Alabama State University, Auburn University, HudsonAlpha Institute for Biotechnology, Tuskegee University, O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB), University of Alabama, and Mitchell Cancer Institute at the University of South Alabama. This year’s grants
meant that BCRFA has made a cumulative investment in breast cancer research of over $16 million since its founding in 1996.
BCRFA funding allows for earlystage studies to obtain preliminary support. Multiple projects from the BCRFA have gone on to receive multimilliondollar grants from national organizations like the National Institutes of Health, amplifying the significance of BRCFA’s investments in Alabama.
Cynthia Owsley, PhD and Michael Niederweis, MD
Nita Limdi, PharmD, PhD
Limdi Named Associate Dean for Genomic Medicine at UAB
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Holland & Knight Named Largest Healthcare Law Firm
Holland & Knight has been named the largest healthcare law firm by Modern Healthcare. The annual Largest Healthcare Law Firms rankings are determined by the headcount of healthcare lawyers employed by U.S. law firms with a dedicated healthcare practice as of December 31, 2023.
In March 2023, Holland & Knight combined with Waller Lansden Dortch & Davis, expanding the firm's Healthcare & Life Sciences Industry Group to more than 400 attorneys covering every segment of the healthcare industry. Previously, both firms had been consistently ranked on Modern Healthcare's annual list for more than 15 years.
Holland & Knight is also recognized
in Chambers USA's list of The Elite healthcare law firms and ranked by the American Bar Association's Health Law Section as one of the largest healthcare practices in the Southeast, Northeast and Washington, D.C.
The firm's Healthcare Industry Group has a particular focus on identified sectors in the market, including hospitals and health systems, post-acute care, ambulatory surgery centers, outpatient care, private equity, physician practice management, behavioral health, digital health, managed care, pharmacies and life sciences.
Trusted Orthopedic and Sports Medicine Care
Colin Luke, Executive Partner of Holland & Knight's Birmingham office.
LOCAL ROOTS. NATIONAL REACH.
With the nation’s largest healthcare law practice according to Modern Healthcare, Holland & Knight has more than 400 experienced attorneys covering virtually every segment of the healthcare industry, from transactional matters, regulatory compliance and real estate to litigation, government enforcement and public policy issues.
Our dedicated healthcare attorneys and professionals – in Birmingham and throughout the country – have the insight, experience, depth and resources to help promote and protect your interests.