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Zephyr® Endobronchial Valve System offers hope for COPD patients By Marti WeBB Slay
Patients with COPD or emphysema have a new treatment option with the Zephyr® Endobronchial Valve System, a minimally invasive treatment with oneway valves which deflate damaged parts of the lungs and allow the patient to breathe more easily. Jay Heidecker, MD, of Birmingham Pulmonary Group at Ascension St. Vincent’s, is one of only four doctors in the state who currently perform the procedure. The procedure itself is not particularly new – Heidecker learned a similar approach during his fellowship 18 years ago – but coupled with the Zephyr valve,
advances have been made that help physicians better know when the procedure is likely to be successful, resulting in overall better outcomes. “The candidates for this procedure are people with emphysema as the primary part of their lung disease, people who are having shortness of breath as opposed to people who are coughing up tons of phlegm,” Heidecker said. “That’s step one. Step two is they should already be taking the right medicines and still feel very limited despite being on the right standard medicines. Number three is their lung function tests should show a lot of air trapping.
Zephyr® value is placed in the airway.
(CONTINUED ON PAGE 3)
Rebuilding the Nursing Workforce in Alabama By Jane ehrhardt
In the past ten years, renewal of licensure data in Alabama found that 5,000 to 7,000 nurses lapse annually at the first of the year. By April, many would normally have reinstated their licenses. But according to the latest Alabama Nursing Workforce Study released this year by the Alabama Board of Nursing (ABN), licensure reinstatements decreased to around 1,800 over those years. Several reasons arise. For example, compact nurses, who hold licensure in other states, now no longer need an Alabama license to practice here. ABN has no way to pinpoint the cause of the drop, but the statewide study of 84,779 licensed nurses did reveal that 38,727 experienced nurses intend to leave nurs-
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ing in the next five years. “We know nursing is a difficult job. Nurses can physically burn out,” says Honor Ingels with the ABN. “It’s also a supply chain issue. We see thousands of qualified potential nursing students denied entry to our programs because there are not enough slots available. The problem lies with a lack of teachers.” However, the ABN has succeeded in convincing the state legislature to pass, though they have not yet funded, a loan repayment program for nurses pursuing graduate degrees to become instructors. The nurses will receive a $15,000 loan that will be forgiven in exchange for working in a public college or university for two years. Though historically around 5,000 (CONTINUED ON PAGE 4)
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Zephyr® Endobronchial Valve System offers hope for COPD, continued from page 1 “When patients blow out air and still have almost two times the air that should remain in their lungs, that indicates they may be candidates for the procedure because that air trapping is causing most of the symptoms.” Contraindications include uncontrolled heart failure, pulmonary hypertension, and patients who are morbidly obese. “The procedure involves hospitalization,” Heidecker said. “Patients must know the risks. Approximately one out of three patients experiences a collapsed lung from the procedure. Although the presence of a collapsed lung doesn’t change the overall success rate, it can result in a prolonged hospitalization, so that’s not a trivial risk. “If a patient is a possible candidate for the procedure and understands the risks, we perform a special CT scan to determine what part of the lung is most diseased and over-inflated. That tells me, if we are to proceed, which lobe of the lung is a good target. It can also show whether there’s a prohibitive risk. The CT scan can also look at fissures between the lobes. If they aren’t intact, the procedure won’t work. The scan and new, special software really increase the safety and the ability to know who is going to benefit from the procedure.” The minimally invasive procedure,
Jay Heidecker, MD
which is not considered surgery because it requires no cutting, is performed under general anesthesia, and takes 60 to 90 minutes. Patients stay in the hospital for four days. “In the initial trial, there were one or two deaths from collapsed lung,” Heidecker said. “If someone has a pneumothorax, it’s much better to know it in the hospital than when the patient is at home. Since 90 percent of the patients who experience a pneumothorax will have it within three days, we keep them where we can see and deal with it.” The first part of the procedure consists of confirming again that it is likely to be successful. “We prove that those divisions between the lobes are intact, so we prove the procedure will collapse the lobe
in the way we want it to,” Heidecker said. “It’s the extra confirmation. Then we put the valves in. We usually have a place we think will be best and a second choice if it seems like the first choice won’t work after all. Each lobe has between two and four main branches, so we put between two and four valves in. Sometimes we put them in two lobes of the lung. We might put in as few as two valves and as many as six.” The valves can be removed if they don’t help or cause a problem of any kind. “If the lobe collapses very fast and the patient has a bad pneumothorax and the pneumothorax won’t stop, I could take the valves out, and that should make the pneumothorax stop,” Heidecker said. “That’s quite helpful.” “For some patients, the only way the pneumothorax will stop is to take the valves out. The data says that 50 percent of the time, you have to take the valves out to make the pneumothorax stop. So, if one in three has a pneumothorax and 50 percent have to have the valves removed, then that’s one out of six patients who have an initial unsuccessful procedure. You can offer the patient a repeat attempt. That’s up to the them as to whether they want to try again.” Heidecker has done four procedures so far. One patient wasn’t helped by the valves, and they were removed.
“We knew there were significant reasons why it might not work,” he said, “and the patient knew that up front.” None of his patients so far have had a pneumothorax as a result of the procedure. For physicians considering referral for this procedure, Heidecker summarized the key considerations. “If physicians have patients with COPD and lots of shortness of breath, make sure we do pulmonary function tests where we measure the lung volumes,” he said. “If they have a patient with emphysema and they are still breathless and have lots of air trapping, those are the people to find and refer. “It’s a lot of work on the front-end from an evaluation standpoint. The physiology is interesting. Why it helps, how it’s working, to me that’s very interesting.” Heidecker was attracted to the procedure primarily because it offers improved quality of life for many patients. “Of all the interventional things we do, whether it’s new bronchoscopy techniques or other therapeutic techniques, almost all those interventions are palliative,” he said. “This is one of the few pulmonary interventions that helps people with a non-terminal problem improve their quality of life. That was the main reason.”
F
Birmingham Medical News
NOVEMBER 2023 • 3
Rebuilding the Nursing Workforce in Alabama, continued from page 1 new graduates will apply for licensure each year, the ABN estimates that RN and LPN vacancies in Alabama could potentially grow to 13,000 or 14,000 in the next four years. With the average age of nurses dropping from 54 to 46, a large exodus of experienced nurses have already left the workforce in the last few years. With the nursing workforce decline spread nationwide, Alabama has turned to cultivating potential graduates through innovative programs. In September, the state legislature approved a $500,000 contract for a feasibility study to be completed by the end of January on the construction of a statewide health-science high school. This will be the first STEM school in Alabama targeted at healthcare. Whitfield Regional Hospital, in Demopolis—a rural township of 7,000–has already been working with local high schools and are the proponents behind the project. “It’s amazing to watch what happens to a young person when they get to observe an orthopedic surgery or see a state-of-the-art treatment center treat a level three or four wound,” says Douglas Brewer, the CEO of Whitfield Regional. Brewer envisions students in their 11th and 12th grades being dual enrolled in nursing programs as well, graduating high school pretty much with an RN and able to go right to work. “It’s going to give
young people, who believe that healthcare is the place for them, a place to go to accelerate their training time,” he says. In Centreville, another rural hospital reached out to their nearby community college to make a change. Two years ago, Bibb Medical Center (BMC) approached Shelton Community College asking how they could help remove barriers for starting a practical nursing program together. The BMC program offered up the classroom space, lab facilities, and staff to build a three-semester program, that included classes in math, biology, and English. They also became an accredited campus of the college. “We asked what they needed and gave it to them,” says Joseph M. Marchant, CEO of BMC. Some students even received scholarships. Books, tuition, school fees, and access to practice testing networks, were all provided. “These are people who are working full or part time at a regular job while going to class,” Marchant says. The LPN certification had seemed out of reach, but would mean a significant economic rise from working at the local gym or Walmart. “Life can get in the way,” Marchant says. “Our goal is to help them. And for them to want to be here for the long haul.” Each graduate of the program receives a job offer from BMC if they
Doug Brewer, CEO of Whitfield Regional.
Joseph Marchant, CEO of Bibb Medical Center.
commit to working there for two years. In August, the first cohort of nine practical nursing students graduated. This fall, 14 more students enrolled. This class also has the opportunity to participate in the state’s new apprenticeship program, which means the they receive a salary for the work they do as they learn at the hospital while still being in school. The new nursing apprenticeship option came about when the state passed new rules in March 2022 to allow Alabama healthcare employers to enter into apprenticeship agreements with nursing programs. Administered through the Alabama Office of Apprenticeship, students accepted as nurse apprentices work alongside an experienced nurse, all the while earning a salary as an employee of the healthcare facility. Statewide in the past year, an esti-
Honor Ingels with ABN.
mated 400 nursing apprentices from 17 colleges have served at more than 60 healthcare facilities. Coastal Alabama and Gadsden State community colleges were the first to offer apprenticeships. During that initial phase, 30 apprentices filled nursing vacancies in four facilities. Alabama is the first state in the country to implement an apprenticeship program at this level. “This has broken through the wall,” Honor Ingels says. “Alabama is now the national model.” Because of their clinical training and one-on-one mentorships, newly graduated apprentices are ready to stand on their own within a few days versus the usual six weeks. “That’s a tremendous savings for the facilities and benefit to the patients,” Ingels says. “Imagine that spread over our state with 400 nurses. That’s an amazing achievement.”
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St. Vincent’s Conducting Phase III Trial for New Anticoagulant Treatments By Marti Webb Slay
Ascension St. Vincent’s is one of only two sites in the state testing new anticoagulant treatments for patients with AFib who cannot take blood thinners. They are enrolling patients in the trial, which is showing very promising results, according to principal investigator Alain Bouchard MD, cardiologist. “AFib is probably one of the most prevalent heart diseases, particularly as our population ages. There are currently about 6 million people with AFib, and it’s predicted to be 12 million by 2030, so very significant prevalence,” he said. Since AFib increases the risk of stroke by five times, and AFib patients who have a stroke tend to have higher disability and increased mortality, most patients with AFib are candidates for anticoagulants. “There are certain things we have to balance, however, such as the risk of stroke versus the risk of bleeding. For example, a lot of our patients who are older have coronary disease and take an aspirin, also have arthritis and take a medication for that. Certain patients have abnormal kidney disease or diabe-
Alain Bouchard, MD
tes. All of a sudden, their risk of bleeding increases,” Bouchard said. This trial is an effort to find safer drugs that balance the risk of stroke with the risk of bleeding, to better treat patients at risk for both. “Years ago, all we had was warfarin. For some patients you don’t have a choice: if you have a prosthetic heart valve, you need to have warfarin. But if you don’t have a prosthetic heart valve and you have AFib, there are better choices,” he said. Studies done 20 years ago showed the efficacy of new drugs, such as Xarelto and Eliquis, factor Xa inhibitors. This
Hemostasis vs thrombosis. Factor XI is a bystander in hemostasis, but critical in thrombosis. Blocking Factor XI doesn’t compromise hemostasis, while preventing blood clots from forming.
current trial is looking at Factor XI inhibitors, and their ability to protect against stroke without increasing the risk of bleeding. “It may be a paradigm shift in how we treat patients with AFib,” Bouchard said. Hemophilia C is a condition where patients are born without Factor XI. “We are trying to imitate what nature brought us. These patients don’t form clots, and
they don’t bleed,” he said. The implications are significant and could mean patients on anticoagulants can have procedures without discontinuing their medication prior to the procedure. “You would remove this concern completely from clinical practice,” said Bouchard. “If you have a drug that is safe and lets you perform what you need to on (CONTINUED ON PAGE 9)
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Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024 By Jessie Bekker
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The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024. The U.S. Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a second temporary extension on October 10, 2023 of its telehealth prescribing flexibility rule. The new temporary rule is the second extension of a policy DEA and HHS first implemented in 2020 in response to the COVID-19 pandemic. Under the Ryan Haight Online Consumer Protection Act of 2008, providers were required to conduct an in-person evaluation of a patient prior to prescribing controlled substances. The onset of the COVID-19 pandemic and the distancing measures that followed led DEA and HHS to issue exceptions to this in-person evaluation requirement, allowing providers to prescribe scheduled medications over audio and visual telemedicine communications. It allowed patients to access medications including opioids like oxycodone, popular medications for attention-deficit/hyperactivity disorder, like brand-name medications Ritalin and Adderall, and medications used to treat substance use disorder, like methadone, after visiting with a provider using telehealth capabilities. On May 10, 2023, the federal agencies issued a first temporary extension of its exceptions to the in-person patient visit rule, allowing providers to prescribe controlled substances to new patients via telehealth through November 11, 2023, or, for established patients, through November 11, 2024, despite the ending of the COVID-19 public health emergency. On or around October 10, 2023, DEA and HHS issued a second temporary extension of the prescribing flexibilities, which will apply to all patient-provider relationships, regardless of when the relationship was established, through December 31, 2024. The latest temporary rule overrides the November 2023 and 2024 deadlines imposed by the May 2023 temporary rule. In promulgating the temporary rule, DEA and HHS stated that it aimed to
Jessie Bekker
“ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescription, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards.” This second temporary extension will allow DEA and HHS time to sort through comments that were recently received in response to two notices of proposed rulemaking, published back in March, related to prescribing via telemedicine. DEA and HHS jointly issued two notices of proposed rulemaking on March 1, 2023 that would have allowed prescribers to provide a 30-day supply of a medication to patients via telehealth, requiring providers to evaluate patients in-person to continue prescribing past the initial 30-day period. It would have also excepted certain medications from telehealth prescribing, requiring an initial in-person visit with a patient prior to prescribing Schedule II medications and narcotics listed as Schedule III through V medications. In response, DEA and HHS received over 38,000 comments, which the DEA noted was among the highest number of public comments in DEA rulemaking history. According to DEA Administrator Anne Milgram, a “significant majority” of commenters expressed concern regarding the restrictiveness of the March 2023 proposed rules on telehealth prescribing capabilities. The agencies continue to review comments to the proposed rules as it works on final regulations. In addition to the receipt of formal comments to the notices of proposed rulemaking, the agencies hosted two listening sessions in September to solicit industry feedback regarding its controlled substances prescribing policies. (CONTINUED ON PAGE 9)
St. Vincent’s conducting Phase III trial, continued from page 6 a patient without interrupting anticoagulation medicine, that’s huge.” There are three different Factor XI antagonists being studied, two of which are being conducted at St. Vincent’s. • Antisense O l i g o nu c l e o t i d e s This trial is not being tested locally. The Phase II study of VTE prophylaxis entailed a weekly injection of Factor XI anticoagulant one to two weeks prior to surgery and up to a month following surgery. “These patients did very well. They compared it to Lovenox and found these patients didn’t have problems with bleeding at all, in much better fashion than just taking Lovenox after the surgery,” Bouchard said. • Antibody Abelacimab “Abelacimab was studied In prevention of blood clot after hip surgery. In Phase II they found they were able to do the hip surgery after giving the medication as an injection once a month, and that prevented blood clot as effectively as Lovenox, yet had less bleeding. In another trial of patients with AFib, the study was stopped early, because they found out compared to Xarelto, the patients treated with abelacimab had less problem with bleeding and were as protected against stroke. In these Phase II studies, over 350 procedures were performed safely without bleeding complications. So we have very encouraging data,” he said. The study of abelacimab at St. Vincent’s started this summer. “In this Phase III trial we are studying patients with AFib who have no option. These patients tend to be older, frail, with multiple falls. So far we have enrolled
four patients. We plan to enroll 1900 patients over the next two years. We don’t expect any interaction with other medication. It can be given intravenously as well as under the skin, which is a big advantage. And it doesn’t require any dose adjustment, even in patients with chronic kidney disease,” Bouchard said. • Small Molecule “This is a third way to block Factor XI,” he said. “The molecule we’ll be studying is milvexian, given as a pill twice a day. This medication has been given to patients with AFib in Phase II and was very effective compared to Eliquis.” In Phase III they will continue comparing it to Eliquis, or apixaban, in patients with AFib. The study began this fall. They will follow these patients up to five years and enroll 15,000 patients worldwide. So far, over 2,000 have been enrolled. “We are studying patients we see every day in the office,” Bouchard said. “There is no age limit and we will include patients with comorbidities. I’m very excited that finally we have a study that includes the patients doctors see in everyday practice. And I’m hoping we enroll as many if not more women than men.” Bouchard wanted to reassure referring physicians that they will continue to treat their patients as usual during the trial. “Doctors know their patients the best.” he said. Physicians interested in referring patients to this study can contact Ashley Gilmore at (205) 212-6031, Ashley.gilmore@ascension.org.
Telehealth Prescribing Flexibilities, continued from page 8
On behalf of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, Shabana Khan, an assistant professor and director of telehealth for the Department of Child and Adolescent Psychiatry at New York University Langone Health of the New York University Grossman School of Medicine, noted that telemedicine has not been shown to increase drug diversion rates. “Prescribing practitioners are able to accommodate social determinants of health and other barriers to inperson care, such as employment hours, family care situations, stigma, violence, reducing flexibility in modalities of care, increases in equity, forcing practitioners to cherry-pick patients that have the ability to travel to in-person care,” Khan argued, calling for provider-led decisions in mandating in-person care as to specific patients, rather than a federal mandate. American Telemedicine Association
Senior Vice President of Public Policy Kyle Zebley noted that telemedicine improved access to care and argued that a special registration process to track telemedicine prescribing of controlled medications “can be an appropriate mechanism for DEA to fulfill its mission of preventing diversion while allowing legitimate telemedicine to occur.” In its new temporary rule, DEA and HHS noted that it is reviewing stakeholder comments to “develop regulations providing access to the practice of telemedicine when consistent with public health and safety, and that also effectively mitigate the risk of possible diversion.” DEA also foreshadowed that it planned to promulgate new standards by fall of 2024. Jessie Bekker is an attorney at Burr & Forman LLP, practicing exclusively in the firm’s healthcare practice group. Jessie may be reached at (205) 458-5275 or jbekker@burr.com.
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Pappas Warns of the Increase of Fungal Infections in the Deep South Ansley Franco
“Southern states face a higher risk of acquiring certain fungal infections amid climate change,” said Peter Pappas, Md and professor in the Division of Infectious Diseases at the UAB Heersink School of Medicine. Consequently, he anticipates the development of more aggressive fungi. Fungi, a complex microorganism that is more closely related to humans than bacteria or viruses, find an ideal habitat in Alabama due to its nutrientrich soil and warm, moist climate. “It's no accident that across the southeast we see more invasive fungal infections than in other parts of this country,” Pappas said. “If you take the hospital-acquired fungal infections and combine them with what is acquired naturally out in the community, you come up with a fair number of invasive fungal infections across the Deep South.” Although fungi are vital for life on Earth, breaking down organic matter and returning it to its original state, a small amount of fungi cause significant diseases in humans. Pappas estimates that
only 100 to 150 fungi out have a population across the of millions pose problems state and the region living in for humans. an area of relative vulnerThere are two types ability. These numbers are of fungal infections that going up everywhere.” humans are at risk of conTo combat this, intracting. Dermatophytes, dustrial anti-fungicides are which are fungal infections used in paints to keep milthat invade keratinized tisdew and mold down, and in sue such as hair, skin and agriculture sprays for crops. nails. This type of infection “Industrial agricultural antithrives in ambient temfungal sprays contribute to Peter Pappas MD peratures and rarely causes human resistance to fungal life-threatening issues. On infections,” Pappas said. the other hand, an invasive fungal infec“The industrial use of fungicides is pretty tion can be considered almost as severe significant worldwide, especially in Northas a bacterial infection that can go unern Europe where they use these sprays to controlled and lead to sepsis and death. keep tulips and flowers from getting ruDeeply invasive or invasive infections can ined as a consequence of fungal infection. manifest in the bloodstream, brain, lung “If people contract a fungal infecor deep tissue infections. tion, some of these threatening fungi “There are several things that prelive on the skin and can become infected dispose you to fungal infection: if you’ve through hospital devices such as a ventireceived a transplant; received lator, where the organism can enter the disease-modifying agents; have lupus, bloodstream. In rare instances, fungi that rheumatoid arthritis, any of the conneclive on the skin can be contracted from tive tissue disorders; HIV; or cancer,” Papperson to person, like Candida auris ((C. pas said. “Like most regions, we have an auris.) C. auris is a germ that poses a abundance of those types of patients. We threat to humans since its origin on five
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continents simultaneously and has arisen from climate change and environmental degradation. It’s particularly difficult because it is, by nature, resistant to one or more antifungals. It’s difficult to eradicate from the environment, and it’s difficult to eradicate from people. It colonizes and it’s hard to rid an individual of it once colonized. So it's difficult to treat because it's resistant and it leads to more death.” Pappas, who is one of the leaders for the Mycoses Study Group (MSG), a world-renowned organization dedicated to providing evidence-based medicine for patients at risk for or afflicted with invasive fungal infections, said the group is working towards getting a protocol through to a study of C. auris. He is confident the group will have something within the next year. MSG is located at UAB, and is the center of clinical research in mycology nationwide. The group organizes and conducts trials for new antifungals, diagnostics and therapeutics while collaborating with sites across the country to better understand the pathogenesis of some fungal infections.
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12 • NOVEMBER 2023
Birmingham Medical News
Cybersecurity and Patient Rights
By Kristin Shoe
In July 2019, Springhill Medical Center in Mobile suffered an eight-day ransomware attack that left medical equipment and patient records largely inaccessible. During this attack, Teiranni Kidd gave birth to her daughter, Nicko Silar. A reduced labor and delivery staff, a compromised hospital network, and impaired monitoring equipment prevented the delivery of standard alerts on patient and fetal status to the nurses’ station. These alerts normally would have led to a Cesarean delivery of this baby, who was born with the umbilical cord wrapped around her neck, but the medical team proceeded with a natural childbirth, unaware of the fetal distress. By the time the baby was delivered, she had suffered severe brain damage that would ultimately lead to her death several months later. Perhaps most tragically, the Ob/Gyn obtained the fetal monitor readout afterwards and subsequently texted the nurse in charge that she indeed would have performed a Cesarean had she understood the situation fully. Furthermore, both the hospital and the medical team failed to inform the patient of the ransomware attack, and each entity blamed the other for the resulting tragedy. Kidd filed a lawsuit in 2021 against both the hospital and Ob/Gyn for an undisclosed amount, and the case is pending. This case and the events leading to it present several lessons and warnings for healthcare organizations. The ransomware attack had been ongoing for a number of days before Ms. Kidd arrived at the hospital. How robust was the hospital’s network security? Had Springhill invested in advanced IT systems and personnel that created regular backups, installed patches quickly, and deployed the latest tools on all devices? Did they train staff to recognize phishing emails and utilize multi-factor authentication? Did they take HIPAA compliance seriously, and were they making continuous efforts to improve adherence? Or, perhaps they took security and compliance very seriously and were thorough in their security protocols, and ultimately the bad guys
Kristin Shoe
still breached their system. Once the hospital realized that it had been breached, did it have an incident response/disaster recovery plan in place that specified procedures for every staff member? Was staff aware of and trained for these alternate procedures? Were backup files easily obtained? Did hospital administration notify patients fully, and did they describe any subsequent reduction in services? Ultimately, the answers to these questions will play a decisive role in the outcome of this case. If the hospital is able to prove that robust security protections were in place, following a HIPAA compliance framework, and a ransomware attack occurred anyway, the judgment against them may be less severe. If hospital staff had a written emergency plan, their defense will be strengthened as well. A comprehensive HIPAA compliance strategy, including robust cybersecurity, is the healthcare provider’s best defense against an attack. If an attack occurs (and even the most advanced security cannot protect your network 100 percent of the time), a detailed plan for every function in the business is essential to maintaining quality of care and business continuity, not to mention that it is a compliance requirement. Click https://www.sipoasis.com/ compliancy to download our helpful HIPAA Compliance Checklist today, and take steps to ensure your healthcare business is protected. Kristin Shoe serves as Director of Marketing at SIP Oasis, a Birmingham IT service provider.
Artificial Intelligence in Healthcare:
How to Comply with HIPAA and State Privacy Laws By Beth Pitman and Shannon Britton Hartsfield
Hardly a day seems to pass that we don't hear about new advances in artificial intelligence (AI.) The healthcare industry has seen its share of technological developments related to the use of AI to improve the quality and efficiency of patient care. A recent high-profile lawsuit, Dinerstein v. Google LLC et al, serves to remind us that new technology is still governed by longstanding laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA). Back in 2017, Google teamed up with a hospital to develop and test AI technology to study how electronic medical records could be used to improve healthcare quality. The collaboration focused on the use of machine-learning techniques to predict hospitalizations and identify instances of declining patient health. To build the algorithm, Google and the hospital exchanged a "limited data set" of patient information. A limited data set is a term defined in HIPAA, and it is protected health information that excludes certain direct identifiers, such as the name, address, Social Security number and medical record number. It is not completely de-identified, but it can include a limited amount of information such as a ZIP code, date of service and similar items. As required by HIPAA, the parties entered into a "data use agreement." In exchange for the hospital providing the data, the data use agreement said that the hospital would receive a "non-exclusive, perpetual license" to use "Trained Models and Predictions" created by Google. This was considered a form of research. In 2019, Google and the hospital were sued in federal court in a potential class-action lawsuit accusing the hospital of sharing hundreds of thousands of patient records that contained identifiable date stamps and doctors' notes. The plaintiff alleged a variety of claims, including a breach of the duty of medical confidentiality, breach of contract arising through the Notice of Privacy Practices and HIPAA Authorizations, invasion of privacy and contract injury based on alleged "sale" of protected health information (PHI) and a right to royalty payment for use of the PHI. The district court found insufficient allegation of injury arising from the claims and lack of standing to assert certain claims, the court granted the defendants' motion to dismiss. The plaintiff subsequently appealed, and recently a federal appeals panel again dismissed the claims based on a lack of standing and absence of injury. The court ruled that merely possessing data or allegedly having the capabil-
ity to re-identify the did not support the plaintiff’s claims. For a violation to occur, there must be bad intent or an actual bad act. This is significant when considering the way AI uses data for its learning process and the potential cumulative impact of all of data sources on the partially deidentified data being accessed and used by the AI. Moving Forward As healthcare providers and tech companies continue to work together, privacy officers and providers must understand the specific details of how the AI interacts with patient information from all sources, including de-identified data from the providers and then analyze the facts to determine how HIPAA and other privacy rights apply and what specifically is required for compliance. Additionally, the Dinerstein decision underscores the importance of having a HIPAA-compliant Notice of Privacy Practices and authorization forms when required. Providers must give patients adequate explanations of what information is collected, how the information is processed and how it might be used. All too often, covered entities either ignore the HIPAA obligation to provide Notices of Privacy Practices or they just copy the government's sample notice or some other organization's notice with-
Beth Pitman
Shannon Britton Hartsfield
out really considering what it says. The government’s model notice says that the covered entity will never sell information unless the patient gives written permission. The lower court in Dinerstein v. Google LLC et al found that similar language was more stringent than HIPAA, and potentially prevented some disclosures permitted by HIPAA, such as an exchange of PHI for a reasonable cost based fee when the PHI is to be used for research. Although it is not feasible for a Notice to contain complete discussions of each and every HIPAA exception, as attorneys practicing in this area, we include a caveat that written authorization will be obtained for a sale of PHI unless the sale is otherwise permitted by HIPAA. Business associate agreements rou-
tinely permit de-identification of PHI. Once de-identified. data uses are no longer regulated by HIPAA. In Dinerstein, the plaintiff alleged that the information was re-identified through Google’s independent collection of data and for that reason was not de-identified data. The courts did not accept this argument but it raises questions regarding when PHI is actually de-identified in accordance with HIPAA. Consideration should be given to a business associate’s request to de-identify data, the process and confirmation of de-identification that includes certification that the data may not be reidentified, and the purpose for which deidentification is being performed The case raises interesting HIPAA (CONTINUED ON PAGE 14)
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NOVEMBER 2023 • 13
EDGE Opens Access to Gastric Procedures for Bariatric Patients By Jane ehrhardt
In 2021, an estimated 262,893 bariatric surgeries were performed in the U.S., according to the American Society for Metabolic and Bariatric Surgery. That represents a rise of nearly 60 percent over the previous decade. One downside to the Roux-en-Y gastric bypass (RYGB) is that it leaves patients with limited options for accessing portions of their digestive tract when issues arise, such as blockages and cancers. “After bariatric surgery, their anatomy is altered,” says Mohannad Dugum, MD, gastroenterologist and advanced endoscopist at Gastro Health Grandview Medical Center. “Areas that we reach easily via routine endoscopy before bypass surgery are now difficult to access, if we can reach them at all.” In the gastric bypass, a small stomach pouch is created and attached via its own branch to the small intestine. This leaves the remainder of the stomach and its natural attachment to the intestines intact, but literally bypassed in the digestive process. It also cuts off the usual endoscopic route from the mouth through the stomach
Mohannad Dugum, MD
to the bile ducts and the pancreas. Instead, reaching those areas for even biopsies can require surgery or a much longer and less effective path through the pouch into the small intestine and back through the stomach to the common bile duct. EDGE (endoscopic ultrasound-directed transgastric ERCP) temporarily recreates that original route. Using only endoscopy, a large stent is placed between the stomach pouch and the excluded stomach, which reverses the gastric bypass. Then surgeons can go through that stent like they do through the normal stomach to reach areas they need to reach
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without any surgery or external incisions. The wide, but short, stent gets inserted two weeks ahead of any procedure. “In that time, the track heals up nicely, so it almost becomes a natural part of the body,” Dugum says. After the procedure, the stent can be left in to retain that access route for as long as needed. When the stent is removed, the hole generally closes on its own. About 15 percent of the holes remain open, according to one clinical trial of 1,000 patients. In those cases, the hole can be stitched or clipped shut in a 15 to 30 minute procedure, if the patient wants. There is no notable downside to leaving the very small hole open except the possibility of weight gain via food passing into the original stomach versus only through the stomach pouch. Considering most EDGE patients are elderly, Dugum generally recommends closing it only if digestion issues have arisen or the patient is very concerned about their weight gain. Surprisingly, the EDGE procedure requires no new technology. Neither the scope nor the metal stent are new. The endoscopic ultrasound scope has been in use since the 1980s. “The innovation is in how we’re using them,” Dugum says. EDGE patients mainly face issues in the bile ducts and pancreas, such as with cysts, masses, leaks, and stones. Bile duct stones top the list. However, the versatility created with the stent access can fulfill multiple needs in one non-surgical procedure in situations as serious as potential pancreatic cancer. “If the drainage from the liver is impaired, we can get biopsies and confirm if it’s cancer, place a stent to relieve the blockage, make the patient feel better, and get them on to the next step of their treatment, without surgery or a hospital stay” Dugum says. The stent-based procedure offers applications beyond gastric bypass patients,
as well. “As an extension of EDGE, we can place stents between different parts of the GI tract, and not just for access,” Dugum says. “For instance, if a blockage forms in the small intestine due to cancer closing down the stomach and preventing a patient from eating, we can use the same technology to place a large stent between the stomach and another loop of the small intestine beyond the blockage. Dugum performed Grandview’s first EDGE procedure in August. “It’s very innovative and it’s satisfying doing something high impact in a relativity quick procedure in the GI lab,” he says. “We don’t have to involve other teams or the OR, and the expense is much better for the patient and the healthcare system. Patients like to avoid surgery, and you produce a huge impact for them.”
Artificial Intelligence in Healthcare, continued from page 13
regulatory issues that will need to be considered for any artificial intelligence project, including whether a particular endeavor triggers HIPAA's "research" provisions, whether data is properly deidentified, whether the right agreements are in place, whether a data transfer is a prohibited "sale" and what promises were made to patients about their data through the Notice of Privacy Practices or otherwise. Beth Pitman is a partner in Holland & Knight's Birmingham, Alabama, office. Shannon Britton Hartsfield is a partner in the firm's Tallahassee, Florida, office.
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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.
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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!
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Birmingham Medical News
NOVEMBER 2023 • 15
Is Living On HighlyProcessed Foods Killing Us?
By Laura Freeman
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Birmingham Medical News
“Roughly 40 to 50 percent of the calories most Americans eat these days come from highly-processed foods, including fast food, take out along with snacks and convenience foods you see at eye level in the middle of the supermarket,” Catherine Anne Couch, PhD, RD said. Working with epidemiologists at the UAB School of Public Health who study how nutrition affects diseases, she finds that trend alarming. “We’re seeing more and more research showing links between highlyprocessed foods and chronic long-term disease processes,” Couch said. “Two studies showed that for every 10 percent increase in consumption of highly-processed foods, risk for heart disease goes up 10 percent and risk for cancer goes up around 12 percent. Beyond that, diabetes, hypertension and obesity are closely related to how our nutritional habits are changing. Now we even see questions about how cognitive decline might relate to what we’re eating.” What exactly is processed food? How do you define the difference between real food and highly-processed food? “Foods are ranked in four categories,” Couch said. “Category one is usually only washed and packaged foods like eggs or tomatoes. At the most, veggies or fruit might be chopped and bagged, ready for a veggie tray. “Category two is typically an ingredient that requires a bit of processing to make it what it is. Olive oil would need to be pressed, and butter would have to be churned. “Category three might be canned, bottled or frozen. It could be as simple as canned fruit with a little sugar added, or ham in a can with water and natural juices. As long as you’re shopping in the first three categories, you’ll probably be doing fine as long as you read the ingredients on category three. You should recognize the ingredients, the list should be short, and you should be able to find most of them in an average kitchen.” The difficulty comes when you get to category four—highly-processed foods. They can be on the shelf just down the
Catherine Anne Couch, PhD, RD
aisle from foods that have a body friendly ingredient list. However, they may have up to 500 additives including some you may have never heard of. The amount of research done on the long-term effects of consuming them may vary. These ingredients range from preservatives to bulking agents, emulsifiers, colors to make them more appetizing, flavor enhancers like sodium, and trans fats, if that’s the fat that tastes best. “Popular brands and fast food restaurants build their business on making their foods highly palatable so people want to consume more of them, more often,” Couch said. “One study showed that people who consume highly-processed foods ate 500 calories a day more than people who ate whole foods. That many calories soon adds up to a battle with insulin resistance and obesity.” People who habitually eat real food also have a built-in advantage at staying fit through life because, while highly-processed foods pass through the stomach quickly, whole foods stick around longer and generally take more energy to digest. It may only be a few calories per meal, but over a number of years, it can add up to the difference between being fit or having to battle middle-age spread. In the millennia of evolution that shaped our digestive systems, it’s easy to see that we made a wrong turn a few generations ago. Unfortunately, it’s harder to see how we’re going to get back to eating and enjoying healthy food. “Health professionals need to understand the critical role real food plays in preventing disease and helping people heal,” Couch said. “We have to get that message through to patients and point them in the right direction to learn how to eat healthier.” We’ve lost a generation of cooks who picked dinner from the garden and knew how to get it on the table in half an hour, (CONTINUED ON PAGE 17)
GRAND ROUNDS
Hilton Joins Internal Medicine Specialists
Jesse Hilton, MD
Jesse Hilton, MD has joined Internal Medicine Specialists of Homewood. Originally from Dallas, Hilton earned his bachelor's degree in biochemistry at Baylor University before completing medical school at Texas Tech University School of Medicine. After medical school, he moved to Birmingham to complete his residency in Internal Medicine at Brookwood Baptist Health, and decided to stay in Alabama to join IMS.
Ascension St. Vincent's Birmingham Names Alridge CNO
Alridge joined Ascension St. Vincent’s Birmingham in 2015 as a House Supervisor and has served as Administrative Director of the Cardiovascular Service Line since 2019. Under her leadership, the cardiovascular service line received the BCBS Blue Distinction® Centers for Cardiac Care in 2022, achieved Transthoracic Echocardiography Accreditation from the IAC, and Cardiac Rehabilitation and Pulmonary Rehabilitation Accreditation from the AACVPR. Alridge has 27 years of nursing experience, starting with her graduation from Wallace State Community College with an Associate’s degree. She later obtained a Bachelor's degree in nursing, as well as a Master’s degree in nursing administration from the University of Alabama - Huntsville. Additionally, She recently passed the ANCC Nurse Executive Board Certification exam and now holds the NE-BC certification.
Kassouf Hires Former Hospital CEO as Healthcare Advisor
over 25 years of experience in acute and post-acute healthcare settings and specializes in operations management, team leadership, patient experience, employee engagement including employee wellness and resiliency initiatives, DEI, safety, regulatory compliance, strategic planning, and clinical excellence. She earned her undergraduate degree from the University of the Witwatersrand in South Africa. She completed her Doctor of Physical Therapy at Rocky Mountain University of Health Professions. She also has an MBA from University of Saint Mary and a Master of Arts from Denver Seminary. Liz is a Fellow of the American College of Healthcare Executives and is a member of the Medical Group Management Association.
Christopher George, MD
Liz Mahon
Penny Alridge, RN, MSN, NE-BC has joined Ascension St. Vincent's Birmingham where she is serving as the new Chief Nursing Officer.
Christopher George, MD Joins Birmingham Heart
Cason Kirby Joins Holland & Knight
Cason Kirby
Penny Alridge, RN
evate Holland & Knight’s reputation in the Alabama legal community, and we are thrilled to have him join our firm.” Kirby received a J.D. degree from the University of Alabama School of Law and a B.A. degree from the University of Alabama, where he also served as president of the student body. He has been recognized by Mid-South Super Lawyers for his business litigation practice every year since 2018 and is a member of the Alabama Law Institute.
Liz Mahon has joined Kassouf, as the firm’s newest healthcare advisor. Prior to joining Kassouf, Mahon worked as the CEO for a rehabilitation hospital in Alabama. Mahon began her healthcare career as a physical therapist in Johannesburg, South Africa, before moving to the U.S. She has
Holland & Knight has added partner Cason Kirby in the Birmingham office. Kirby’s practice includes a broad range of commercial disputes with particular experience in business competition issues. He was previously a partner with Campbell Partners. “Cason represents an exciting opportunity for the firm to continue to expand its litigation practice both locally and nationally,” said Colin Luke, executive partner of Holland & Knight's Birmingham office. “He will greatly assist in our efforts to el-
Christopher George, MD joined Birmingham Heart Clinic in September. He is a Cardiac Electrophysiologist, who specializes in heart rhythm disorders. He has developed an expertise in procedures such as ablation of abnormal heart rhythms, implantation of pacemakers and defibrillators, and left atrial appendage occlusion. George is originally from Montgomery, and completed his residency at the University of Alabama at Birmingham and fellowship at the University of Texas Health Science Center at Houston. He is currently accepting new patients at the Pilot location.
Is Living On Highly-Processed Foods Killing Us?, continued from page 13 building flavors with savory fresh ingredients and herbs to make homemade taste preferable to takeout. Before we lose another, we need cooking classes, even if they are on YouTube. The person who cooks needs to know about convenience techniques like sheet pan meals; making two and freezing one; slow cookers; and once a month freezer prep meals. A second class could teach people how to grow their own food. Even a 2 x 2 foot space on a deck is enough room for a tower garden to grow 30 or more salad vegetables or strawberry plants. Children need a chance to see first-hand what real food is and how much fun it is to eat the food you grow.
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NOVEMBER 2023 • 17
GRAND ROUNDS
Hanna Joins Cardiology Specialists
UAB Purchases Two Real Estate Properties
Ibrahim Hanna, MD has joined Cardiology Specialists at Ascension St. Vincent's. Hanna is board certified, and has a special interest in all aspects of cardiac electrophysiology (EP), ranging from device related procedures to ablations. Ibrahim Hanna, MD He speaks English, French, and Arabic, and attended Medical School at the American University of Beirut in Lebanon. He did his Residency and his Internship in Internal Medicine at the Emory University School of Medicine before completing a Fellowship in Cardiology at Emory.
In September, UAB closed on real estate contracts on the Daniel Building, located at 15 20th Street South, and a medical office building located at 1715 11th Ave. South. The 19-story Daniel Building was purchased by the UAB Medicine Enterprise for $16 million. The building includes approximately 316,000 square feet of office space and is located a few blocks from The Kirklin Clinic, The Whitaker Building and the Marnix E. Heersink School of Medicine’s Lyons-Harrison Faculty Office Tower. “The building offers the opportunity to consolidate administrative and support services, and provide space to accommodate UAB Medicine’s growing enterprise,” said Dawn Bulgarella, CEO of the UAB Health System. “Its proximity to UAB Medicine facilities provides opportunities to expand clinical care facilities in alignment with the UAB Medicine Facility Master Plan.” The university is also acquiring a singlestory, 6,100 square foot medical office building on the southern edge of campus for $1.15 million. The university plans for future redevelopment of the property within the scope of the long-range master plan.
Children’s Approved for Renovations The State Health Planning and Development Agency has approved the Certificate of Need by Children’s of Alabama for renovations. The project involves the building out of the 12th floor of the Benjamin Russell building, which is currently shelled space, to serve as a 50-bed unit for critical care patients. To better serve behavioral health patients, the hospital will renovate the 5th floor of the McWane building and operationalize 11 additional beds for the unit. Six bassinets will be added to the NICU. Children’s licensed bed capacity will remain at 332. The project, which will cost nearly $55 million, will be completed in the fall of 2026.
The Daniel building.
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Medical Association Awards $4,000 Minority Scholarships for Medical School EDITOR & PUBLISHER Steve Spencer
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The Medical Association of the State of Alabama (MASA) awarded $4,000 scholarships to minority medical students Desalyn Johnson and Elijah Morris to help pay the cost of medical school. The Underwood Minority Scholarship Award is named in honor of Dr. Jefferson Underwood, III, a Montgomery physician who was the first African American man to serve as the Association’s president. African American students who are already attending medical and osteopathic school or who have been accepted to school are eligible to apply for the scholarship. Johnson graduated summa cum laude from UAH with a Bachelor’s degree in Biological Sciences and a minor in Spanish Language. She received an NIH-funded National Research Service Award to investigate the effect of insurance status on infant mortality and morbidity rates in the United States. In addition, Johnson has served as a Medical Student Peer Tutor, Diversity Ambassador and Louis Stokes Alliance for Minority Participation Mentor. Morris graduated from Stonehill College in Massachusetts with a Bachelor’s
(Left to Right): Elijah Morris, Dr. George Koulianos of MASA and Deslyn Johnson.
degree in biology and now attends Edward Via College of Osteopathic Medicine at Auburn University. In 2023, he was awarded the John Peter Smith Diversity in Medicine Visiting Student Scholarship and was also recognized as a Hispanic Scholarship Fund Scholar. A New York native, Morris is a member of the Gold Humanism Honor Society and the Auburn chapter of
Sigma Sigma Phi. “Alabama doctors are honored to present these scholarships to Desalyn and Elijah,” said Dr. George Koulianos, a Mobile physician who serves as President of the Medical Association. “These students have demonstrated remarkable dedication and promise in their pursuit of a career in medicine.”
Samford’s Haun Receives National Award Courtney N. Haun, PhD, MPH, Assistant Professor and Director of the Healthcare Administration Undergraduate Program at Samford University was recently recognized as the recipient of the 2023 Association of University Programs in Health Administration (AUPHA) Teaching Excellence Award in Health Policy. This national award, which was sponsored by the American Hospital Association, honors faculty in the AUPHA Network who demonstrate teaching excellence within various disciplines. Haun receives award.
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