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PATHS Offers Rural Providers Access to Pediatric Mental Health Training Children’s of Alabama, in partnership with the Alabama Department of Mental Health, has found a way to help physicians facing the shortage of pediatric mental health providers in rural Alabama ... 3

Hospital Price Transparency Rule – January 1, 2021 Effective Date As if hospitals don’t have enough challenges with the fallout from COVID-19, they also need to comply with the new Hospital Price Transparency Rule ... 4

Andrew Smith, MD Develops Groundbreaking AI for Radiology Andrew Smith MD, PhD, doesn’t refer to the AI he helped to develop as artificial intelligence ... 8 FOLLOW US

JANUARY 2021 / $5

Alabama Nurses Miss Out on CARES Act Funding Lindsey Harris, President of ASNA, addresses nurse advocates at the State Capitol in February 2020.

By Ann B. DeBellis

In September 2020, the state of Alabama was awarded $1.8 billion in Coronavirus Aid, Relief & Economic Security (CARES) Act money to support health care organizations and providers, communities, and businesses impacted by the COVID-19 pandemic. Healthcare providers and services were a priority focus of the

intended use of the funds. Many healthcare needs in Alabama have been met as a result of this funding, but one critical sector was ignored – our nurses. “The CARES Act funding was supposed to bring relief to communities, institutions, small businesses, and people who had been directly impacted by COVID-19 in a provable, negative financial way,” says John Zeigler, Execu-

tive Director of the Alabama State Nursing Association (ASNA). “I understand that many businesses were impacted, but what about nurses who caught COVID and were sent home? For many, their sick leave ran out and they were home for three weeks to a month and unable to get back to work until the time period was over. How do you to make up for that?” (CONTINUED ON PAGE 7)

UAB Clinical Trial Underway for COVID-19 Treatment By Jane Ehrhardt

Virus 2019 (COVID19) in Outpatients, tests the hypothUAB is looking for Covidesis of a paper published onpositive individuals for an outline in Physiological Reviews patient study that examines the on March 27 by UAB’s Sadis effect of a common drug on Matalon, PhD, and colleagues inhibiting the progression of in Texas and San Francisco. the disease, especially in people In the research literature they with comorbidities. Devised by reviewed for the paper, they Tim Ness, MD, PhD Tim Ness, MD, PhD, professor note that all the comorbidiemeritus with UAB Department of Anties, such as diabetes, hypertension, cereesthesiology and Perioperative Medicine, brovascular illness, coronary heart disease the study focuses on dampening the role and chronic obstructive pulmonary disof plasmin in activating the coronavirus. ease, feature elevated levels of the proteThe study, titled TXA and Corona ase plasmin.

A biochemical action of plasmin is to cleave little segments of proteins off. This nicking increases infectivity in many viruses. The researchers noted that COVID-19 has such a site on its spike protein, and proposed that plasmin may cleave it, therefore increasing the virus’s potency and infectiousness. That made plasmin a promising therapeutic target for combating COVID-19. “It turns out that when you cleave some of the proteins in the Covid virus, it appears to be able to enter cells more easily and to start its viral processes more eas(CONTINUED ON PAGE 10)




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PATHS Offers Rural Providers Access to Pediatric Mental Health Training By Jane Ehrhardt

Children’s of Alabama, in partnership with the Alabama Department of Mental Health, has found a way to help physicians facing the shortage of pediatric mental health providers in rural Alabama. The Pediatric Access to Telemental Health Services program, or PATHS, aids rural primary care providers in diagnosing, treating and managing mild to moderate behavioral health conditions in children and adolescents. According to the CDC, almost 10 percent of children ages two to 17 years were diagnosed with ADHD (attentiondeficit/hyperactivity disorder), totaling about 6.6 million in America. Another 4.5 million have a diagnosed behavior problem, and the same amount for anxiety. Complicating the diagnosis and treatment further is that in children with behavior problems, more than one in three also have anxiety and about one in five also have depression. The need for this specialty care is more apparent among children living below the poverty level, where more than one in five had a mental, behavioral or developmental disorder. Couple this with the lack of pediatric mental health specialists in rural Alabama, and the burden on primary care providers and pediatricians in those counties becomes apparent. “The PATHS program has developed a community of providers in what has previously been an isolated practice arena,” says Susan Griffin, LICSW, PIP, CHCQM, director of PATHS at Children’s. “These doctors, who may have been the only sole providers in their area, are now able to learn from each other which has been exciting to see.” For the past two years, with grant monies from the U.S. Health Resources and Services Administration (HRSA), Griffin has visited about 20 rural pediatricians and family practices so far, explaining the opportunities available through PATHS. “That personal visit tells them what we have to offer, so they understand up front and we can start that relationship right then,” Griffin says. The first year, five practices enrolled. Last year, that more than tripled to 16. The program revolves around three components, the first being an online collaborative training series of five to eight sessions each. Held during lunch hours every other week, the initial series in fall of 2019 drew 25 participants. “Then the next summer, we had 30, and by the third one this fall, we had 49. So you can see the growth,” Griffin says. The topics have ranged from anger management and passively suicidal behaviors to anxiety related

PATHS meeting, from left: Kristin Adams, Susan Griffin, and Staci Smith.

to Covid and trauma exposure. The sessions follow the ECHO model with the Children’s team of licensed behavioral health professionals and an infant/early childhood mental health consultant forming the hub and the enrollees in PATHS forming the spokes. The intent is to not only provide specialty knowledge from the mental health experts at Children’s, but gain insights from each other on cases they’ve faced or are facing on that topic and what worked. “It’s not just the doctors who attend, either, but also their nurses, their NPs and their clinical assistants. You’re training the whole group,” Griffin says. One physician, who includes his

staff in the training, recently shared with Griffin the difference that made when a patient showed up in crisis. “He said, in the past, they might have struggled to know what to do, but because of our sessions, every one of his team members knew what they was needed,” Griffin says. “The patient got their needs met because of the training we provided. That is a huge win.” The second component of the program allows enrollees’ patients to call a dedicated line at Children’s for a oneon-one teleconference with a behavioral health professional. But Griffin stresses that PATHS is not a crisis service. “If a patient is truly in crisis, it’s not appropriate to be seen by telemedicine,” she says.

“They need to be seen by someone close by or in our office.” The third part of the PATHS program allows physicians the opportunity to access to consultations after they have implemented treatment recommendations. Griffin says this is one of the most valuable pieces of the program. Since this service launched in November 2019, they have held 65 tele-consultations. PATHS is not a passive learning endeavor. “It’s a hands-on program,” Griffin says. “The doctors hear what to do with a particular problem, specific information on how to manage the meds for certain diagnosis, but also very specific things for behavioral concerns.” They receive a wealth of resources in paper or online sources after each training session, and get a written summary of recommendations from the Children’s experts and the other providers who had been on the session. “Many of these pediatricians are already doing this work,” Griffin says. “But this is enabling them to do it even better, and with more confidence.” Physicians also receive their Category 1 CME credit from attending the series. “The program is free of charge,” Griffin says. “And their nursing staff can also get CE credit from the nursing board. There’s not much reason for them not to engage with us.”

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Hospital Price Transparency Rule – January 1, 2021 Effective Date By Anthony Romano

As if hospitals don’t have enough challenges with the fallout from COVID-19, they also need to comply with the new Hospital Price Transparency Rule (See 45 C.F.R. Part 180) which is effective January 1, 2021. This rule requires hospitals to establish, update, and make public online: (i) a list of their standard charges for items and services in a machine readable format, and (ii) a list of certain shoppable services in a consumer-friendly manner. The Hospital Price Transparency Rule received substantial pushback, including a lawsuit filed by the American Hospital Association in December 2019, challenging that it exceeds CMS’ authority, violates the First Amendment, and is arbitrary and capricious. On June 23, 2020, the United States District Court for the District of Columbia rejected all of those challenges and granted summary judgment to the defendants, ruling in favor of CMS. The American Hospital Association has since appealed the ruling, and a three judge panel on the D.C. Circuit Court of Appeals heard oral arguments in the appeal

on October 15, 2020. However, a ruling has not been issued at the time this article was submitted. In addition to the appeal, multiple hospitals across the U.S. sent joint letters to the U.S. Department of Health and Human Services urging CMS to delay the effective date of the Hospital Price Transparency Rule until its legality is fully adjudicated by the courts, due to the burden compliance would represent for hospitals in the midst of responding to the COVID-19 public health emergency. CMS has given no indication that it intends to push back the January 1, 2021 effective date. Given the outstanding status of the appeal, and lack of indication by CMS that the effective date will be pushed back, hospitals should be confirming they comply with the requirements of the Hospital Price Transparency Rule – an overview of which is listed below: 1. Who is required to comply with the Hospital Price Transparency Rule - “Hospitals” - CMS requires “Hospitals” to comply with the Hospital Price Transparency Rule and defined Hospitals to mean an institution in any State in which State or applicable local law provides for the licensing of hospitals, that is licensed

as a hospital pursuant to such law or is approved, by the agency of such State or locality responsible for licensing hospitals, as meeting the standards established for such licensing. CMS did not exempt rural hospitals or critical access hospitals. To the extent considered a “Hospital” pursuant to the above definition, longterm care hospitals, inpatient psychiatric facilities, and inpatient rehabilitation facilities will have to comply with the Hospital Price Transparency Rule as well. Federally owned or operated hospitals are deemed by CMS to be in compliance with the requirements of the Hospital Price Transparency Rule because their charges are publicized to their patients, the facilities do not provide services to the general public, and the established payment rates for services are not subject to negotiation. 2. Machine Readable Online List of Standard Charges for all

Items and Services - The Hospital Price Transparency Rule requires each Hospital to establish, update annually, and make public online a “Machine-Readable File” containing a list of all “Standard Charges” for all “Items and Services.” Each hospital location operating under a single license (or approval) that has a different set of standard charges than the other locations under the same license or approval must separately make public the (CONTINUED ON PAGE 6)

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Children’s of Alabama is dedicated to helping kids live the most fulfilling life possible. We put in a lot of time and training to make that happen.

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Hospital Price Transparency Rule, continued from page 4 standard charges applicable to that location. The list made public by the Hospital must include any code used by the Hospital for purposes of accounting or billing for the item or service. 3. What is included in “Items and Services” - CMS defined “Items and Services” to mean all items and services, including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge. Examples include, but are not limited to, the following: (1) supplies and procedures; (2) room and board; (3) use of the facility and other items (generally described as facility fees); (4) services of employed physicians and non-physician practitioners (generally reflected as professional

charges); and (5) any other items or services for which a Hospital has established a standard charge. 4. What are the “Standard Charges” that must be disclosed on the list – CMS defined standard charges to mean the regular rate established by the Hospital for an item or service provided to a specific group of paying patients. This includes: • Gross charge – the charge for an individual item or service that is reflected on a hospital’s chargemaster, absent any discounts. • Payer-specific negotiated charge - the charge that a hospital has negotiated with a third-party payer for an item or service. • De-identified minimum negotiated charge - the lowest charge that a

hospital has negotiated with all thirdparty payers for an item or service. • De-identified maximum negotiated charge - the highest charge that a hospital has negotiated with all thirdparty payers for an item or service. • Discounted cash price - the charge that applies to an individual who pays cash (or cash equivalent) for a hospital item or service. 5. What is a Machine Readable Format Online – Examples of machinereadable formats include, but are not limited to, .XML, .JSON and .CSV formats. CMS noted that a .PDF file is not included as a machine-readable format. 6. Shoppable Services Displayed in a Consumer Friendly Manner - Since the amount of data in a machine readable list may be not easily

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Birmingham Medical News

understood by consumers, each hospital is required to make public certain standard charges in a consumer-friendly pricing display. Hospitals are required to display pricing for 70 CMS specified shoppable services (if offered; and noted if not offered) and as many additional hospitalselected shoppable services as is necessary for a combined total of at least 300 shoppable services (or as many shoppable services as the hospital provides, if 300 are not provided). A shoppable service is a service that can be scheduled by a healthcare consumer in advance. Hospitals must provide the following information for each listed shoppable service and ancillary service: (i) plain language description; (ii) indication of any CMS-specified shoppable services that are not offered by the hospital; (iii) payerspecific negotiated charge; (iv) discounted cash price (or undiscounted gross charge if a discounted cash price is not offered); (v) de-identified minimum negotiated charge; (vi) de-identified maximum negotiated charge; (vii) location where the service is provided, including whether the standard charge applies at that location in the inpatient setting, outpatient setting, or both; and (viii) any primary code used by the hospital for purposes of accounting or billing. The shoppable services must be published online without barriers, and be searchable. However, a hospital is deemed to meet these consumer friendly disclosure requirements if the hospital maintains an internet-based price estimator tool that: (i) allows users to obtain an estimate of the amount they will be obligated to pay the hospital for the shoppable service; and (ii) is prominently displayed on the hospital’s website and accessible to the public without charge and without having to register or establish a user account or password. 7. Penalties for Non-Compliance – If CMS concludes a hospital is noncompliant with its obligations under the Hospital Price Transparency Rule, CMS may provide a written warning notice to the hospital, request a corrective action plan from the hospital, and/or impose a civil monetary penalty of up to $300 per day (which amount will be adjusted annually). 8. Estimated Cost of Compliance - CMS estimates that the total burden for a hospital to review and post its standard charges for the first year will be 150 hours per hospital, at an estimated cost of $11,898.60 per Hospital, with the annual burden to review and update such charges in subsequent years being 46 hours per Hospital at $3,610.88 per Hospital. CMS anticipates that the Hospital Price Transparency Rule will affect approximately 6,002 Hospitals. Anthony Romano practices with Burr & Forman LLP in the firm’s Health Care Industry Group. Anthony may be reached at aromano@burr. com or (205) 458-5210.

Alabama Nurses Miss Out on CARES Act Funding, continued from page 1 ASNA, which represents 100,000 nurses throughout our state, conducted a survey that asked nurses to comment on the current state of their profession during the COVID pandemic. The survey identified three broad groups of nurses. “Front-line nurses wanted to work and fulfill their duties, but they were faced with a lack of tools, such as personal protective equipment (PPE) and long shifts,” Zeigler says. “Many nurses also had psychological stressors that most had never experienced, such as a fear of going home and carrying the virus to an elderly parent or a husband and children. It impacted their whole life, not just their work life.” Another group of nurses, referred to as sideline nurses, had secure jobs for years until their units suddenly closed in March, April and May because hospitals stopped elective surgeries. “That put thousands of nurses out of work. Depending on how long they had been employed, some had vacation time but all were facing terrible uncertainty,” Zeigler says. “They wanted to be at the hospital serving people, but they were put on the sidelines and were suffering in a different way.” A third group of nurses are the senior nursing students who have graduated and taken their licensing exams and are ready to enter the workforce. “Because of unit closures and hiring freezes, they are in limbo. Hospitals can’t do training or orientation, because there is no staff to do it,” Zeigler says. “When they signed up to become a nurse, they made that commitment in their hearts. They are ready to go to work.” Lindsey Harris, DNP, FNP-BC, President of ASNA and a UAB nurse, experiences the daily struggles of nurses on the front lines. “Right now, nurses are stressed as hospitals put in more COVID beds, which means fewer beds for other acute patients,” she says. “So, it is a stressful time for us to be left

out of the funding, but as nurses we remain resilient and continue to do what we have to do to care for our patients.” Harris says the job is hard when you are short-staffed, because nurses are leaving for other hospitals or for travel nurse assignments. “Through the CARES Act, we asked for funding for our struggling nurses, but many of them had to leave their jobs,” she says. “So many nurses have been impacted financially, but I don’t want to make this all about finances. Nurses do what they have to do to help others. At the same time, we are putting our lives and our families’ lives on the line.” With the new Coronavirus vaccine ready to be disseminated, Harris points out that nurses will be educating the public about the vaccine and will be the ones to administer the shots. “We as nurses are considered the most trusted profession, and nurses are utilized in every aspect. We are treating and educating patients, administering vaccines and so much more. I wish we had received some funding, because we are part of the providers at the forefront of the virus,” she says. Harris wants nurses to know that ASNA is the voice for nurses. “We advocate for them and we speak out about the profession. We are here for them,” she says. “I invite all nurses to join ASNA at alabamanurses.org and add their voices to advocate for their profession.” Zeigler points out that because of this crisis, the stability of nursing has turned in many ways. “The appeal of stability and the loyalty of a certain institution in many places around the country have been rattled, and that is not healthy for our system. We just hope that the governmental policy makers and employers will help take care of our nurses so the nurses can take care of us,” he says.



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Andrew Smith, MD Develops Groundbreaking AI for Radiology By Laura Freeman

Andrew Smith MD, PhD, doesn’t refer to the AI he helped to develop as artificial intelligence. “We call it augmented intelligence, because it’s designed to work interactively with humans to generate better information and facilitate better decision making,” Smith said. Vice Chair of Clinical Research and Director of the Human Imaging Shared Facility at UAB, Smith runs the Comprehensive Cancer Center’s Tumor Metrics Lab. He is Director of Artificial Intelligence, Tumor Metrics and Entrepreneuership in Radiology. After becoming frustrated by the lack of cutting edge information technology for radiology that could improve efficiency, accuracy, standardization and generate tools to make radiology more useful to physicians and patients, Smith put his interest in AI and software to work creating it. “We designed a suite of software to work with multiple platforms, so there’s no need to purchase specialized equipment,” Smith said. “When 20 other institutions evaluated it, the feedback was

8 • JANUARY 2021

Founder Andrew Smith MD PhD (center) with COO Bob Jacobus and Product Manager Paige Severino.

very positive, especially regarding the faster patient analysis, higher accuracy and reduction in errors. Of 24 radiologists, 96 percent preferred our AI platform to the system they had been using, and 100 percent of the 20 oncologists preferred the more robust, detailed reports it gave them.” In addition to guiding and improving work flow, trials of the system showed a 25 percent improvement in efficiency, a 99 percent reduction in major errors, and a 55 percent increase in interobserver

Birmingham Medical News

agreement with better standardization. “When we are following a patient with advanced cancers or liver disease, it’s important to get precise readings on any changes so physicians will have accurate evidence to judge whether a therapy is working or needs to be changed,” Smith said. “Different radiologists may read imaging from one time to the next, or different people may be reading imaging for tumors in different organs. The AI platform takes any subjective influences out of the equation, precisely measuring

and calculating very small changes.” One of the improvements in the speed of reporting is that the AI platform eliminates the need for radiologists to deal with the time-consuming task of dictating their findings. One touch is all it takes to generate digital reports that can be sent to the physician’s computer, including a range of informational tools that can serve as visuals to improve communications with patients when discussing their case with them. “In addition to text, the graphs, tables and key images can help patients see how they are doing and understand why their physician is recommending that they continue with a course of treatment or perhaps change medications or try a different approach to care that might work better,” Smith said. The AI platform has already been approved by the FDA and in the EU for use in tracking liver and kidney diseases, and FDA approval is expected within a few weeks for using it to track tumors in advanced cancers. “When I told people I thought we could use this approach to track the progression of fatty liver disease and (CONTINUED ON PAGE 10)

HHS Issues Fraud Alert on Remuneration with Healthcare Companies Speaker Programs By Colin Luke

The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies. The OIG and Department of Justice (DOJ) have investigated numerous fraud cases involving allegations that compensation offered and paid in connection with speaker programs violated the antikickback statute, and the Federal government has pursued civil and criminal cases against pharmaceutical and medical device companies and individual health care professionals (HCPs) involving these speaker programs. Congress enacted the anti-kickback statute, in part, to protect patients from referrals or recommendations by HCPs who may be influenced by inappropriate financial incentives. Individuals and companies violate the statute when compensation purposefully induces or rewards the referral of items or services payable by a Federal health care program.

While healthcare company-sponsored speaking events were created with the purpose of educating listeners regarding the use or value of a company’s medical devices or medications, OIG revealed that often, “HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.� These cases “strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.� These speaking events are significant

investments for the companies involved and that many providers have earned significant amounts from appearing at these events. OIG reported that drug and device companies have reported paying nearly $2 billion to HCPs for speakerrelated services over the last three years. OIG also notes that the information shared at speaking events can be found via other sources, such as online resources, information in a product’s packaging, third-party educational resources, medical journals and more. As a result of the inherent risk in using speaking events to share informa-

tion, these events may be subject to increased scrutiny. Below is a selection of the characteristics OIG provided in its Alert to provide an illustrative, though not exhaustive, list of features that indicate a speaker program arrangement could potentially violate the anti-kickback statute. The company sponsors speaker programs where little or no substantive information is actually presented; Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free); The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues); The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information; There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product; The company pays HCP speakers (CONTINUED ON PAGE 12)

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UAB Clinical Trial Underway for COVID-19 Treatment, continued from page 1

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had no effect on blood clotting, because that would make it simpler. We wouldn’t have to give the second drug to avoid potential problems.” This small, exploratory study of 100 participants is the initial safety and feasibility step to determine whether TXA has some beneficial action for those with the coronavirus. “We need to examine the safety of TXA in this situation because having Covid is not the same as being healthy, and there could an interaction between the drug and the disease processes,” Ness says. “That’s why this particular study is limited to people who are within the first seven days of their symptoms.” The participants—19 years old and older—are then studied for seven days following the five-day treatment. “We want to find out if TXA can minimize the impact of the subsequent symptoms for people who test positive for COVID19,” Ness says. If the TXA treatment could reduce the infectivity and virulence of the virus, it could lessen the severity of symptoms and the need for lengthy hospitalization, especially those in vulnerable populations with comorbidities. Ness encourages physicians to pass along the UAB phone number—205-934-6777—to their patients who have recently tested positive for COVID-19. “If physicians have patients wondering if there is something out there, they can call and find out every study available at UAB on Covid right now, of which this is one of them,” he says.

Groundbreaking AI for Radiology, continued from page 8

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ily. It’s basically activated,” Ness says. “So people with high plasmin levels tended to do worse with the virus.” Ness, however, saw a possible blockade to the plasmin cleaving action. “As an anesthesiologist, I use a plasmin inhibitor on a daily basis, called tranexamic acid (TXA). Almost every cardiac bypass and orthopedic surgery case uses it, because of its action on inhibiting plasmin formation,” he says. TXA is an FDA-approved, inexpensive drug that stops plasmin from converting from its inactive form of plasminogen to the active protease form. “It’s overthe-counter in the UK, Japan, and East Asian countries. And in Japan they use it off-label as an antiviral,” Ness says. It’s approved in the U.S. for treating heavy menstrual bleeding because of its effect on clotting—which is also related to plasmin levels—and is being reviewed for use in Cesarean section surgeries. “We use TXA because of its antiviral action,” Ness says. “TXA doesn’t form clots, even though it’s used to help with clotting.” Plasmin breaks down the protein fibrin which is what forms the clots. TXA inhibits plasmin, thus requiring those in the study to also take a blood thinner to counteract any potential effects from the lowering of plasmin. Therefore, each patient in the study takes a daily pill for five days of both TXA along with Eliquis—a blood thinner generically known as apixaban. “They counteract each other’s potentially bad things, but leaves the antiviral effect of the TXA,” Ness says. “We wish TXA

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fibrosis, some of them actually laughed in my face. But as it turned out, the nodularity of the surface of the liver made a virtual liver biopsy possible, which is a less painful and less invasive way to screen for liver problems and track them,” Smith said. Although coming from a family of doctors might have influenced his career choice in any case, Smith’s passion for helping others through medicine grew out of the loss of his physician grandfather to cancer. “All of us have lost people to cancer,” he said. “I wanted to make a difference. We are still losing 600,000 people a year to cancer, and that has to change. That’s why I became a radiologist and why I keep working to find better ways to fight cancer and other life threatening diseases.” An advocate for kidney cancer patients, Smith, along with his team, did much of the early development of the AI software working in kidney cancer research. UAB investigators are now using

the platform as a research tool to track CT and MRI findings of tumor response to potential new targeted therapies for solid tumors in advanced cancers. To make the platform widely available, Smith founded and is president of AIMetrics, a company that is already attracting commercial interest nationally and internationally from as far away as South Korea. The project has also attracted major grants to further develop its potential. “The AI has been trained on 60,000 tumors and we hope to reach 100,000 within a couple of months,” Smith said. “The AI continues to learn. Although the FDA doesn’t allow continual updating, the new information the AI learns is annotated and used in periodic upgrades so it continues to teach itself to become better. “In the future, we hope to develop the AI to use with earlier stage cancers and other conditions such as brain lesions, aortic aneurysms and eventually, we hope, in clinical use in a broad range of radiology applications.”

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HHS Issues Fraud Alert, continued from page 1

more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs. Ultimately, OIG suggests that companies should assess the need for in-person programs, particularly given the risks associated with offering or paying related compensation, and consider alternative, less-risky means for conveying information. While the pandemic has effectively curtailed many in-person events for the time being, OIG says it makes this a good time for providers to review past activities and establish stronger policies and guidelines for participation in future events, or to establish a policy against participating in such events If you have questions about a specific speaker program arrangement involving remuneration to referral sources, the OIG Advisory Opinion process remains available. Colin Luke is a partner and a member of the board of directors of Waller.


Salas Receives Grant to Study Diet for Preterm Infants Ariel Salas, MD, MSPH, assistant professor in the Department Ariel Salas, MD of Pediatrics at UAB, has been awarded a $777,384 grant from The NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development to study protein-enriched human milk diets for extremely preterm infants. Postnatal growth failure occurs in approximately 60 percent of the nearly 26,000 extremely preterm infants born every year in the United States. Premature infants born at 28 weeks’ gestation or less who enroll in the trial will undergo a protein-enriched human milk diet during the first two weeks after birth to see if there is a result in more lean body mass accretion and more diversity of the gut microbiome by the time of hospital discharge. “Our discoveries could shift current standards of care delivered to premature infants,” Salas said.

Walker Baptist Names New CNO Walker Baptist Medical Center has name Lori Sumner, MSN, RN chief nursing officer. Prior to

Lori Sumner, MSN, R

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UAB Medicine Listed Among Most Wired Hospitals for 2020 In 2020, for the seventh consecutive year, UAB Medicine has been named one of HealthCare’s Most Wired by the College of Healthcare Information Management Executives (CHIME). The Most Wired list acknowledges health care organizations that have adopted information technology to improve patient safety and health outcomes across the industry. CHIME has recognized 71 hospitals for achieving Level 9 status in its 2020 HealthCare’s Most Wired program. UAB Hospital is the only Alabama hospital to achieve Level 9 status this year.

Southern Research Leadership Appointments


12 • JANUARY 2021

joining the Brookwood Baptist Health System, Sumner served as associate chief nursing officer of Capital Regional Medical Center, located in Tallahassee, Florida. Sumner, who has 20 years’ of nursing experience, obtained her bachelor’s degree in nursing from Nova Southeastern University in Davie, Florida and master’s degree from Walden University in Minneapolis.

Southern Research has named Michael Catalano and Mark Suto, PhD chief operating officer and vice presi-

dent for Life Sciences, respectively. Previously, Catalano served as interim COO and Suto was VP for Drug Discovery and interim VP for Drug Development. Michael Catalano Catalano joined Southern Research in 2017 as general counsel and assumed the interim COO role in 2018. As permanent COO, he will continue to manage the day-to-day operations. Mark Suto, PhD Catalano’s previous roles include serving as general counsel at Influence Health; chief operating officer and general counsel for SilverStaff; vice president of finance for Caesars Entertainment; and senior development counsel for CVS Caremark. Since joining Southern Research in 2011, Suto has developed multiple research collaborations spanning a diverse array of diseases. In his new role, he will build on ongoing efforts to unite Drug Discovery and Drug Development to optimize growth in SR’s Life Sciences portfolio and impact. He has over 35 years of experience working in several large pharmaceutical companies, as well as smaller biotech and venture-backed organizations.


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GENE STANCUT, MD Dr. Gene Stancut joins the Total Skin & Beauty Dermatology team as a highly-trained Mohs micrographic surgeon and board-certified dermatologist. His Micrographic Surgery and Dermatologic Oncology fellowship, directed under Dr. Conway C. Huang at UAB (Birmingham, AL), is one of the largest and most reputable programs in the nation. Dr. Stancut’s specialization in Mohs micrographic surgery will provide patients the most advanced method of skin cancer treatment, offering the highest cure rate available and the smallest surgical wound possible.

We are pleased and honored to have Dr. Gene Stancut on our team! GENE STANCUT, MD








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JANUARY 2021 • 13


GeneCapture Creates Rapid Portable Pathogen Identification Test Directly from Sample Hunstville-based GeneCapture has created the world’s first multi-pathogen identification using non-amplified RNA detection. Its one hour CAPTURE PLATFORM™ (Confirming Active Pathogens Through Unamplified RNA Expression) is on track for commercialization within two years. “We have made history – this is the first time an automated rapid pathogen identification has been reported directly from the sample, with no modification or amplification of its genetic source, in about an hour,” said GeneCapture CEO Peggy Sammon. “We envision a future where finding out why you are sick can be solved almost anywhere, in an hour, and without being chained to a lab. Just as the shift from central computers to handheld devices enabled entirely new markets, so will decentralized, portable multi-pathogen infection detection.” Whether the illness is bacterial, viral, fungal or protozoan, a single test will pinpoint the cause. The technology consolidates sample prep and molecular signature detection in one plastic cartridge with a portable reader. The closed cartridge accepts a direct sample (urine, blood, swab) and then concentrates and exposes the pathogen’s

14 • JANUARY 2021

BlueCross BlueShield of Alabama MAPD Plan Receives Four-Star Rating

GeneCapture’s disposable cartridge integrates sample prep and pathogen identification.

RNA fragments to the custom DNA probes on an array. Once the RNA is captured, the specific probes activate an optical sensor. The pattern across the array identifies the pathogen. The CAPTURE PLATFORM™ does not require enzymes or refrigeration and will have an expected shelf life of over a year. Without a need for enzymes, the test cost and complexity drop dramatically, allowing non-medical personnel to perform tests without access to a lab. This ease of use will open up new markets for infection detection at schools, day care centers, clinics, airports, and

Birmingham Medical News

many other locations. The initial molecular binding concept was conceived at The University of Alabama in Huntsville and licensed to GeneCapture, which is an associate company at the HudsonAlpha Institute for Biotechnology. The company has since filed an additional 11 patents, built prototypes, and performed successful pre-clinical validation tests. In addition to the commercial applications, the company has been awarded multiple Department of Defense contracts to mature the technology for potential farforward military operational use.

BlueCross BlueShield of Alabama’s Blue Advantage Complete PPO Plan, a Medicare Advantage Prescription Drug plan, has received a four-star quality rating from the Centers for Medicare and Medicaid Services (CMS). Blue Cross’ Blue Advantage Premier PPO Plan also received the four-star quality rating from CMS. CMS uses a five-star system to measure the quality of Medicare Advantage health and prescription drug plans. The overall star rating is based on three main categories: Medical Care, Member Experience and Plan Administration. Star ratings are published each year based on information from member surveys, Medicare monitoring activities, and clinical data and health plan data.

Bivins Named President of Urology Centers of Alabama Urology Centers of Alabama has named V. Michael Bivin, MD as the new president. Bivins, who has been with Urology Centers for 18 years, received his B.S. V. Michael Bivin, MD in Microbiology from the University of Alabama and his M.D. from UAB. He completed his residency in


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Urology at the University of Oklahoma and a fellowship in Urology Oncology at the University of Washington Bivins’ main area of clinical interest is in urology oncology, robotics and reconstructive urology. He performs a number of procedures, including robotic prostatectomy, cystectomy, both partial and radical nephrectomies, subtotal prostatectomy, female pelvic prolapse, and urinary reconstruction including ileal conduit and neobladders. He also provides care for patients with stone disease, erectile dysfunction, benign prostatic hyperplasia, and incontinence. Bivins, who is a retired member of the United States Air Force Reserve, is on the boards of the Jefferson County American Cancer Society, YMCA and Urology Foundation. He is the Chairman of the Department of Surgery at Baptist Princeton and is the President of

University of Alabama School of Medicine Medical Alumni Association. He is a current member of the University of Alabama President’s cabinet and is an advisory board member of the Honors College at the University of Alabama. He is a member of Leadership Birmingham and Leadership Alabama, along with the American Urology Association. He gives back to the community by providing free prostate screenings for low socioeconomic areas.

UAB Orthopaedics Launches Urgent Care Clinic UAB has opened a new urgent care orthopaedic clinic, which is run by the Department of Orthopaedic Surgery and located at UAB Highlands Hospital. The clinic is open on Mondays and Wednesdays during the startup phase with plans to expand to five days a

week later, and focuses on conditions such as hand, wrist and ankle sprains, contusions, general joint pain, and nonoperative fractures. It is staffed by advanced practice providers. Orthopaedic surgeons and physicians are available as needed. “Following initial examination by emergency physicians, those patients with orthopaedic issues that can be best treated in an orthopaedic urgent care setting will be routed out of the emergency department and into the clinic,” said Andrea Boohaker, MSN, CRNP-BC, lead advanced practice provider in the Department of Orthopaedic Surgery. “This will help with overcrowding in emergency departments and get these patients to the most appropriate care providers more efficiently.

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Birmingham Medical News is published monthly by Steve Spencer ©2021 Birmingham Medical News, all rights reserved. Reproduction in whole or in part without written permission is prohibited. Birmingham Medial News will assume no reponsibilities for unsolicited materials. All letters sent to Medical News will be considered Medical News property and therefore unconditionally assigned to Medical News for publication and copyright purposes. ——————————————————




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JANUARY 2021 • 15

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all the

Driving business, practicing law.

Waller is proud to be recognized as #1 in the South region in the ABA Health Law Section’s 2019 Law Firm Recognition List.

wallerlaw.com No representation is made that the qualit y of the legal ser vices to be per formed is greater than the qualit y of legal ser vices per formed by other l aw yers . Cont ac t: Colin Luke 205-226-5717.

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