Birmingham Medical News December 2021

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Children’s South Adoption Clinic Addresses Needs of Adoptive Families By MArti WeBB slAy

Families who adopt often find their children have complex medical, emotional and developmental needs, due in large part to significant transitions other children haven’t faced. For nearly 20 years, Children’s South, the Children’s of Alabama location near Acton Road, has hosted The Adoption Clinic to address those needs. For instance, a birth mother may not have had prenatal care or may have abused substances during her pregnancy. The children may have been in orphanage care or foster care. Many children have experienced emotionally difficult transitions.

“We assess our patients in three areas - medical, emotional and developmental - to make sure they are able to meet their greatest potential and overcome any difficulties they may have experienced,” said Jennifer Chambers, MD, MPH & TM. The team of professionals at the clinic distinguishes between multidisciplinary care and interdisciplinary care. “That is an important distinction for us,” Chambers said. “In the case of multidisciplinary clinics, patients usually show up in one location to see specialists in different disciplines as a way to make it easier on the patient’s schedule. Interdisciplin(CONTINUED ON PAGE 3)

Adoption Clinic team, L to R: Lynn Zimmerman (medical assistant), Heather Schuck (family therapist), Jennifer Chambers (pediatrician), Carin Kiser (pediatrician), Amy Elmore (occupational therapist), Jessica Ward (clinic coordinator)

UAB One of the First in the Nation with New AI-Driven Linear Accelerator System Samuel Marcrom, MD

Dennis Stanley, PhD

By lAUrA FreeMAn

Getting good results from radiation depends so much on delivering the right dose to the right place for the right amount of time. Up until now, the measuring and planning required to give each patient the optimum treatment to destroy malignant cells and keep healthy cells safe has been a formidable endeavor that can take one or two weeks.

Personalized Precision Adaptive Radiation Therapy

In that time, patients can gain or lose weight. Maintaining the optimum placement is especially difficult in areas where the body is a moving target—the lungs, abdomen and pelvis where something as simple as what the patient had for lunch can throw calculations off by precious millimeters. Now a new AI-driven linear accelerator system called Ethos® from Varian® is bringing personalized precision

adaptive radiation therapy to UAB’s oncology patients. The Ethos is the first system that can quickly scan a patient when they are on the table prepping for their next treatment and adapt as needed. UAB Medicine and the Department of Radiation Oncology are also among the first in the nation to install an Ethos system. There are only 12 currently operating in the United States.

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“We’ve been working to bring the platform to our patients since the benefits of the technology became clear a couple of years ago,” oncologist Samuel Marcrom, MD of UAB’s O’Neal Comprehensive Cancer Center said. “ It should greatly enhance the efficacy of treatment and minimize radiation exposure to healthy tissue, especially in patients who have malignancies in areas (CONTINUED ON PAGE 3)

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Children’s South Adoption Clinic Addresses Needs of Adoptive Families, continued from page 1 ary means we work together. One of our specialists will go into the patient’s room and gather information, then we conference about that information and the next specialist goes in. We have three specialists and our nurse, who knows our patients well. Together, we come up with a plan to help the child. “The three areas of medical, emotional and developmental are very integrated in a child, and it’s hard to pull out what’s most important, and what is impacting the child most. You need to look at it from all three angles, so you can know what to prioritize. “Take, for example, a case when parents suspect their child has ADHD. The clinic will check labs to make sure medical issues are not the cause of attention deficit. A family therapist will assess whether anxiety is playing a role, and an occupational therapist will test to see if sensory issues are distracting the child. “That’s an example of a case where the child has been adopted for a while. On the other hand, if they are newly adopted, they may have a myriad of difficulties. Let’s say a child is newly adopted from India. The child may be malnourished; they may be developmentally delayed and they could have no attachment to their parents. We could give those parents hours and hours of homework every day, but no parent can do that. So we look at the child’s list of difficulties together and prioritize what’s do-able for the parents for the next three months, until we see them again.” Originally named the International Adoption Clinic, the clinic’s name was changed a couple of years ago as more calls came from domestic adoptions and foster parents requesting services. The clinic works with the child’s pediatrician to support their care. “If you are doing primary care, you don’t have time to dive into all the issues related to adoptive care,” Chambers said. “I was trying to do it as a primary care physician when I first started, and it was difficult to get everything done. That’s when we decided to start the clinic.” The clinic team brings a personal perspective to their work, since several of them are adoptive parents themselves. “We aren’t just treating our patients, but we are also learning how to parent our own kids effectively,” Chambers said. “There is a better doctor-patient relationship when you are going through the same things as your patient. It doesn’t have to be that way to offer good care, but it’s a benefit we enjoy.” The clinic staff includes two pediatricians, an occupational therapist and a family therapist. “Because it takes so long to train people, we try to see everyone ourselves rather than expanding our staff. We do use specialists all over

the Children’s and UAB, and they know our kids well. We collaborate with plastic surgery, neurosurgery, cardiology, orthopedics, ophthalmology, ENT, neurology and others,” Chambers said. The clinic starts working with families even before they adopt by providing educational seminars. Once a family is matched with a child, the clinic also provides pre-adoption services, going over the medical files for the child to help families make a more informed final decision about adopting a particular child. Once the child is adopted, the clinic begins post-adoption services. “It’s never too late to come to clinic,” Chambers said. “Even if a teen was adopted at the age of three, if they are struggling, we will do an interdisciplinary consult to figure out what’s going on. There are a lot of kids struggling now because of the pandemic school changes, or maybe parents are starting to notice the difficulties more now that they are spending more alone time with their child.” Many of the clinic’s original patients are now adults, allowing the team to see the difference they’ve been able to make in their lives. “It’s very fulfilling,” Chambers said.

UAB One of the First in the Nation with New AI-Driven Linear Accelerator System, continued from page 1 that tend to be mobile.” After a thorough initial CAT scan, the oncologist and radiation physicist work together to plan the treatment strategy and meet again after each session. “Together we evaluate each treatment and fine tune plans for the next treatment. Imaging while the patient is on the table allows us to adapt weekly or even daily,” Marcrom said. “ Since our first use treating patients in early August, five UAB oncologists have been using the system, and many more of our physicians will be using it to care for patients as they learn its capabilities and train in how to apply them.” The technical side of implementation was shepherded by UAB radiation physicist Dennis Stanley, PhD. “Much of my time over the past year has been devoted to acquiring and installing the system, testing and evaluating it, and learning its capabilities and how to use them.,” Stanley said. “We work closely with oncologists in planning and fine-tuning treatments. Staying still for radiation isn’t easy. I can see if a patient moves or if their body has changed since the last treatment, and I can adapt the placement there and then. We don’t lose the effect of that treatment on cancer cells, and we don’t have healthy tis-

sue affected by radiation. “The Ethos system is made by Varian, a leader in this type of technology. It’s very user friendly and works using a true neural net adaptive intelligence with the calculating power to provide solutions in near real time. “The AI can calculate from the last position and quickly adapt to mark the correct position so treatment can continue on schedule. In the first month, we treated around 100 cases and the performance has been impressive. We should be seeing this technology used widely in the future.” Marcrom said, “Patients have been very excited about being treated using this system. They see it as giving them access to maximum benefits with minimal side effect.” It will take time to accumulate data to determine definitively what effect the greater precision of adaptive radiation will have on outcomes, but those using it in patient care are quite optimistic. “This could well be a fundamental shift in radiation treatment,” Marcrom said. “It gives us a much better tool to help our patients.”

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DECEMBER 2021 • 3


Pharmacogenomics Becoming a Valuable Tool in Clinical Care By Ann B. DeBellis

While genetics provides opportunities to maximize the safety and efficacy of medicines, pharmacogenomics, which studies how a patient’s DNA affects her response to drugs, aims to tailor medical treatment to each person or to a group of people. Pharmacogenomics can improve a patient’s health by knowing ahead of time if a drug is likely to benefit her and is safe to take. “Your response to medications depends on many things,” says Nita Limdi, PharmD, PhD, professor in the UAB Department of Neurology and director of the pharmacogenomics program. “It is influenced by your age, weight, kidney function, liver function, diseases you have and drugs you may be taking. It is also influenced by your genetic makeup. To understand how genes affect responses to medications and the clinical applications, physicians can use the genes that are impactful to help decide which medications and what dose to give patients. “Research teams are working together around the world to conduct studies to identify pharmacogenes. Because we need large data sets and many contributors,

it became natural to collaborate with people in our institution, as well as throughout the United States and around the world.” In 2015, Limdi and her cohorts studied cardiology patients who received stents for a blockage in the heart. To prevent platelets from sticking together and causing stent thrombosis, patients were treated with two anti-platelet drugs, aspirin and clopidogrel (Plavix). “In order to work, clopidogrel needs to be converted to its active form with an enzyme,” Limdi says. “If the patient has a loss-of-function variant in the gene that codes for the enzyme, it can’t create enough active metabolite, and the platelets will stick to one another, which means the stent may thrombose.” In collaboration with other researchers, Limdi and her UAB team collected data at nine sites where 30 percent of patients have loss-of-function. “We discovered that if you keep these patients on clopidogrel, 15 out of 100 of them will have a heart attack, stent thrombosis, a stroke or will die within a year,” she says. “However, if you switch these patients to an alternative antiplatelet, only seven will have a bad outcome. It drops from 15 to seven per 100 patients annually. That is

Nita A. Limdi works with pharmacogenomics to maximize the safety and efficacy of medicines.

a 50 percent risk reduction, which is huge.” Building on this work, Limdi and cohorts analyzed the cost effectiveness of genotypeguided therapy. The analysis included variability in medical costs from events that are borne by the payer, such as admissions, procedures, medications, clinical visits and genetic testing. “We found that the genotypeguided strategy is the most costeffective under current circumstances,” Limdi says. “That was powerful because this work brought the research full circle, from discovery of the gene that influences clopidogrel response, to evidence generation and synthesis of guidelines, to its application in clinical care to demonstrate efficacy and cost-effectiveness in the real world. The gene-outcome associations are similar across African, Caucasian, Asian and Hispanic groups. “This process improves outcomes and is cost-effective. Genetic testing costs

money, but it can tell you which patients need the more expensive drug instead of giving it randomly to 30 percent of the people. By preventing heart attacks and strokes, we are actually improving the cost-effectiveness ratio.” UAB will soon be launching a panelbased approach for pharmacogenomics. This will give providers genetic information that can be used to tailor medications for many conditions, such as cancer and depression. Information will also be available in the medical record to (CONTINUED ON PAGE 12)

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Urology Centers of Alabama to Open Men’s Health Center

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By Marti Webb Slay

Urology Centers of Alabama (UCA) is readying a new center dedicated to men’s health, which will open in the first quarter of 2022. The UCA Men’s Health Center will aim to provide specialized healthcare to men even if they don’t have a primary care physician. “Men are notorious for not seeking out preventive health care,” said Jason Biddy, UCA CEO. “They often wait until they have symptoms or it’s too late. We’re trying to create an environment to attract a younger generation of men. We will treat all ages, but if we can get them in during their 40s and 50s, and they get used to coming regularly, there will be greater long-term benefit to their health.” The center will focus on five areas of health: • Sexual health, including erectile dysfunction, low testosterone and Peyronie’s disease. “This is the area most in the industry focus on,” Biddy said. “But other factors play into men’s health as well.” • Metabolic health, including nutrition, fitness, sleep disorders and weight management. • Prostate health, but not prostate cancer. • Infertility. • Vasectomies. “We hope to be a one-stop shop for a man who doesn’t have a primary care doctor,” Biddy said. “While we don’t fully function in that way, we can look at whether he needs a cardiac consult or whether it’s time for a colonoscopy. We can’t do those procedures, but we can facilitate that care with other specialists in the community.” Biddy studied a clinic in Arkansas with a similar approach, and he has goals for how to approach care for each patient by starting with a healthcare checklist. They will complete a sexual health inventory screening, an International Prostate Symptom Score and a Berlin score to assess sleep issues for every new patient. “There are studies that link sleep apnea with ED and men’s health issues,” Biddy said. “We want to establish care before it becomes an issue. If they come in and establish care and get baseline labwork, it becomes preventive.” The UCA Men’s Health Center will accept patients without physician referral, unless their insurance requires it. “If you are having signs and symptoms of a problem, we can treat you,” Biddy said. The clinic has six providers, Brian Christine, MD, specializing in men’s sexual health; David Qi, MD, who spe-

Jason Biddy, CEO of Urology Centers

cializes in reconstructive urology and ED; three general urologists, Drs. Austin Lutz, Lee Hammontree, and Mell Duggan; and Nurse Practitioner Eric Westerlund, whose primary focus is low testosterone. UCA will also be moving its current ED department to the Men’s Health Center. Patients will be treated by a group of specialty-trained registered nurses, overseen by the UCA urologists. The center will provide a comfortable atmosphere with leather chairs and televisions set to sports events, along with 10 exam rooms for a more intimate setting. “I don’t think peoples’ expectations are very high when they go to the doctor,” Biddy said. “We are trying to set the bar for patient experience with the atmosphere, the doctors and the service we are going to offer.” Three years ago, UCA opened a women’s clinic in Homewood Plaza, and the new Men’s Health Center will be next door. “There will be advantages to having the clinics located next door to each other,” Biddy said. “We’ll be able to treat couples. One of our urogynecologists told me she can treat a female patient, but if her partner is impotent, we can only solve 50 percent of the issue. If we can treat couples, especially when it comes to sexual health, then that becomes a big plus.” Biddy said BPH is another issue that is often a couples’ problem. If the husband is getting out of bed five times every night to go to the bathroom, that becomes a sleep issue for the wife. Being able to address the prostate problem improves quality of life for both.

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DECEMBER 2021 • 5


The OIG’s Updated Healthcare Fraud Self Disclosure Protocol By James F. Henry

On November 8, 2021, the United States Department of Health and Human Services (“HHS”) amended its provider self-disclosure protocol (the “SDP”) which was originally published in 1998 to establish a process for health care providers to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs. The November 8, 2021 amendment (the “Amendment”) increases the minimum amounts required to settle self-disclosed instances of potential fraud and makes other changes that provide additional guidance for provider self-disclosures.

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In addition to emphasizing the obligation of healthcare providers to detect and prevent fraudulent and abusive activities, the Amendment discusses the benefits of self-disclosure of potential

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fraud to the OIG. One of these benefits is the OIG’s presumption against requiring integrity agreements in self-disclosure cases. Another benefit is that entities that self-disclose and cooperate with the OIG during the self-disclosure process are expected to pay a lower multiplier of damages than would be required in the case of a government-initiated investigation. The OIG’s general practice in self-disclosure cases is to require a minimum multiplier of 1.5 times single damages, whereas up to triple damages may be assessed in cases of government-initiated investigations. A third benefit is suspension of the obligation to report and return overpayments within 60 days of identification, or the

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day upon which a corresponding cost report is due, when a timely self-disclosure has been made to the OIG. CMS has agreed to suspend the obligation to return overpayments until a settlement agreement is entered into under the SDP or the disclosing party withdraws or is removed from the SDP. Finally, the OIG has committed to working with those self-disclosing and, as part of that commitment, has streamlined its internal process to reduce the average time an SDP case is pending to less than 12 months. Further, the OIG has changed the timeframe for entities to submit the findings of their completed internal investigations and damage calculations from 90 days from acceptance into the SDP, to 90 days from the date of the initial submission. All healthcare providers, suppliers, or other entities that are subject to the OIG’s civil monetary penalty (“CMP”) authorities are eligible to use the SDP. Entities making disclosures under the SDP should disclose conduct for which it may be liable, including potential successor liability based on the purchase of another entity. Disclosing parties should not, however, use the SDP to disclose the conduct of another unrelated party. Entities that are already subject to a government inquiry, such as an investigation audit, etc., are not automatically precluded from using the SDP. Even entities under corporate integrity agreements may use the SDP. The SDP may be used to disclose and facilitate the resolution of conduct that in the disclosing party’s reasonable assessment, potentially violates laws for which CMPs are authorized. Importantly, when making a disclosure, the disclosing party must acknowledge that the conduct is a potential violation of federal criminal, civil, or administrative laws. The disclosing party must specifically identify the laws that may have been violated and should not refer generally to federal laws, rules and regulations, or other similarly broad language. Statements such as “the government may think there is a violation, but we disagree” may create questions about the matter whether the matter is appropriate for the SDP and may result in the disclosure being removed from the SDP. The SDP is not available to address potential violations of law for which CMPs are not authorized, such as routine overpayments or errors. Such situations should be disclosed directly to CMS or the appropriate contractor under the voluntary refund process. The SDP is also not appropriate for the purpose of requesting an opinion from the OIG regarding whether a violation has occurred. Where the arrangement in question only involves potential liability under the Stark law, without potential liability under the anti-kickback statute (“AKS”), the ar(CONTINUED ON PAGE 8)

6 • DECEMBER 2021

Birmingham Medical News


UAB MEDICINE NEUROSURGERY WELCOMES THREE NEW SURGEONS! Jakub Godzik, MD Dr. Godzik joins UAB Neurosurgery as an assistant professor specializing in minimally invasive and complex spine surgery. Having received extensive training in complex spinal reconstruction and deformity correction, as well as minimally invasive spine surgery, his clinical interest include surgical correction of deformity, revision spine surgery, as well as utilizing minimally invasive approaches, robotics, and endoscopic techniques for general spinal pathology.

Marshall Holland, MD Dr. Holland joins UAB Neurosurgery as an assistant professor specializing in functional neurosurgery. With extensive training in stereotactic and functional neurosurgery, his clinical interests include deep brain stimulation (microelectrode guided awake and image guided asleep), surgical approaches to epilepsy, and facial pain/trigeminal neuralgia.

Philip Schmalz, MD Dr. Schmalz joins UAB Neurosurgery as an assistant professor of neurosurgery. After completing a residency at UAB focusing on skull-base surgery and acoustic neuromas, Dr. Schmalz served six months clinical fellowship at Beth Israel Deaconess-Harvard Medical School’s Brain Aneurysm Institute, and completed fellowship in neuroendovascular surgery at Duke University. His clinical interests include complex cranial and skull-base surgery, as well as open and endovascular surgery.

To refer a patient, visit uabmedicine.org/referneurosurgery or call 1-800-822-6478. Neurosciences One – Second Floor • The Kirklin Clinic of UAB Hospital • 2000 6th Ave S, Birmingham, AL 35294

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Birmingham Medical News

DECEMBER 2021 • 7


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The OIG’s Updated Healthcare Fraud Self Disclosure Protocol, continued from page 6 rangement should be disclosed to CMS through its self-referral disclosure protocol (“SRDP”), not the OIG’s SDP. Before making a disclosure under the SDP, the entity should correct the conduct in question or, at least, ensure that corrective action will be taken and the improper arrangement will be terminated within 90 days after submission under the SDP. Addressing the conduct in question prior to submitting a disclosure under the SDP necessarily requires that the entity conduct an internal investigation prior to the disclosure. The results of the investigation should be submitted as part of the disclosure. If the entity is unable to complete its internal investigation prior to submitting the disclosure, the disclosing entity must certify that it will complete its internal investigation within 90 days of the date of submission. Disclosures under the SDP are submitted to the OIG’s website at https:\\ OIG.HHS.gov\compliance\self-disclosure-info\provider-self-disclosure-protocol\. Details necessary for the disclosure include, but are not limited to (1) identifying information about the disclosing party; (2) an organization chart and description of pertinent relationships and identifying information regarding a related entity; (3) contact information for the disclosing entity’s designated representative; (4) concise statement of the details of the conduct being disclosed; (5) identification of the federal criminal, civil, or administrative laws that have been potentially violated by the disclosed conduct; (6) the federal healthcare programs affected by this disclosed conduct; (7) an estimate of damages; (8) the corrective action taken by the disclosing entity; (9) whether the disclosing entity is aware of any current inquiry by a government agency or contractor into the disclosed conduct; (10) identification of the individual who is authorized to enter into a settlement agreement on behalf of the disclosing entity; and (11) certification that the submission is truthful and based on a good faith effort to bring the matter to the government’s attention for the purpose of resolving potential liability to the government. If a disclosure involves a potential submission of improper claims, the disclosing entity must estimate the amount improperly paid and prepare a report of its findings. The improperly paid amount will be considered a measure of single damages and may either be calculated based upon all of the claims affected by the disclosed matter or based upon a statistically valid random sample of the claims that can be used to estimate the total population of the claims affected by the disclosed conduct. This damage calculation may not be reduced by underpayments discovered during the entity’s investigation. If using a random sample to estimate damages, the sample must be at least 100 items and must use the arithmetic mean to estimate damages. The government will expect smaller sample

sizes to be used where the claim population has a high level of homogeneity and larger sample sizes where the population contains a mixture of claim types. The report must include, at a minimum, the objective of the review, the population of claims examined, the source of the data, the qualifications of the individuals conducting the review, and the characteristics of the claim involved in the sample. Where a disclosure under the SDP involves the employment of, or contracts with, persons who appear on the OIG’s list of excluded individuals, the disclosure must identify (1) the excluded person; (2) the job duties performed by that person; (3) the dates of the person’s employment or contractual relationship; (4) a description of any background checks completed before or during the person’s employment or contract; (5) a description of the disclosing entity’s screening process; (6) a description of how the conduct was discovered; and (7) a description of any corrective action taken. If the disclosing entity either employed or contracted with an excluded person who separately submitted bills to federal healthcare programs, the disclosure must include the total amounts claimed and paid by the federal healthcare programs for such items or services. When a disclosed matter involves non-separately billed items or services, damages are estimated using the disclosing party’s total costs of employment or contracting during the person’s exclusion. Such costs include salaries and benefits related to employment of the person. The total cost should be multiplied by the disclosing entity’s revenue-based federal healthcare program payor mix for the relevant time period. Where the disclosed conduct involves potential violations of the AKS, the disclosing entity must estimate the amount paid by federal healthcare programs for the items or services associated with the potential AKS violations and, if applicable, the Stark law. The amount must include the total amount of remuneration involved in the disclosed arrangement, without reductions for remuneration that the disclosing party believes was offered, paid, solicited, or received for a lawful purpose. The disclosing party may, however, explain what it believes to be remuneration that should not be considered fraudulent. The OIG has broad discretion to accept or deny such proposed reductions in damages. In self-disclosures, the OIG coordinates with the Department of Justice (“DOJ”) and, in some cases, the DOJ may choose to participate in the settlement. If so, the DOJ determines its approach for resolving the matter. The OIG will, however, advocate for the disclosing entity to receive a benefit from disclosure under the SDP. Certain situations may raise questions about whether the disclosing entity should utilize the OIG’s SDP or CMS’s SRDP (CONTINUED ON PAGE 12)


Tivity Health Keep Seniors Engaged and Connected

By Cindy Sanders

Aging happens to us all with each passing day, month and year. Aging actively is an entirely different proposition. It’s a dedication to the latter that drives Tivity Health to connect nearly 75 million eligible members nationwide to programming that supports living longer by living well. Richard Ashworth, PharmD, MBA, joined Tivity Health in June 2020 as president, chief executive officer and a member of the company’s board of directors. Although fairly new to Tivity Health, Ashworth spent nearly 30 years with Walgreens, beginning on the front lines as a pharmacist. “As a pharmacist, I spent the majority of my career helping people when they were sick,” Ashworth said. “I saw a lot of people who were not living their lives in a way they could or should. I wanted to try to get in front of that to help people before they need medications, and I believe that an active lifestyle and social engagement play a critical role on health and well-being.” Tivity Health has three core brands focused on that mission. Prime® Fitness connects employees to approximately 12,000 fitness facilities across the country to support a commitment to regular exercise. WholeHealth Living® is a managed network of chiropractic, physical therapy, therapeutic massage, acupuncture and complementary alternative medicine providers to reduce pain. Perhaps the most famous, SilverSneakers® has become the country’s premier community fitness program for older adults. About 18 million seniors are eligible for SilverSneakers, which utilizes more than 15,000 facilities across the country for interactive classes. “Moving is such an important component of longevity,” Ashworth said. “We want people to live the last third of their lives in the best shape they’ve ever been in.” However, he’s quick to add the program is about so much more than movement. The classes also provide participants with social connection and engagement.

“I love that our program is not only fun and accessible but that it actually works,” Ashworth said, pointing to a recent independent study by Avalere Health that found participating in SilverSneakers reduced healthcare costs by 16 percent. With the average outof-pocket Medicare cost for individuals being about $5,300 per year, this means that participants in the Tivity program saw that average drop to $4,460. Pandemic Pivot

During the early days of the pandemic with so much uncertainty, the company recognized a need to keep seniors moving and find an outlet with some sense of normalcy and engagement. “We knew the business model was going to have some pressure. A lot of gyms were temporarily closed,” Ashworth said. The result was to create virtual programming. In addition to answering a need for SilverSneakers participants, the interactive classes opened the door to a larger audience, resulting in a doubling of participation. Although most gyms have now reopened, Tivity Health research has shown that 84 percent of people using the digital product will continue to do so even after adding in-person classes back into the mix. Building off this digital success, Tivity is rolling out SilverSneakers Connect at the beginning of 2022. “We are launching a national social platform that has nothing to do with fitness but is all about connecting people with similar interests,” Ashworth said. The pandemic underscored the importance of human connection to an overall sense of well-being. Tivity conducts an ongoing healthy living survey for older adults, and recently found that 39 percent of seniors had experienced social isolation in the last week. Building off a successful pilot program, Ashworth said reaction to the new platform has been incredibly positive. Finding someone who shares your enthusiasm for college sports, swapping recipes or discussing books provides a reason to get up each morning and get engaged. And that is key to living well longer.

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DECEMBER 2021 • 9


Sweeping Medical Record Changes Proposed for Alabama Physicians Medical Record Access

By Howard Bogard

The Alabama State Board of Medical Examiners and the Alabama Licensure Commission have proposed a complete overhaul of the rules affecting medical record management by Alabama physicians (the “Proposed Rule”). Currently, there are few State guidelines with respect to medical record access, copying and patient notification, which often leads to disputes when a physician leaves a medical practice. The Proposed Rule establishes for the first time detailed requirements for accessing, retaining and disposing of patient medical records, as well as patient notification of a change in physician status. Following notice and a public comment period, the Proposed Rule is expected to become final in January of 2022. Once finalized, a physician risks licensure disciplinary action for violating any of the new provisions.

The Proposed Rule requires that following receipt of a “legally compliant request” from a patient or a patient’s legal representative, a physician or his or her practice “shall provide a copy of the medical record to the patient or to another physician, attorney, or other person designated by the patient or the patient’s legal representative.” While the term “legally compliant request” is not defined in the Proposed Rule, it likely means a request for medical record access that complies with HIPAA. Copying costs for medical records must not exceed what is authorized under state and federal law. The Proposed Rule also specifically addresses Alabama physicians who practice telemedicine, stating that such physicians must retain access to medical records in order to document the delivery of health care services via telemedicine. Also, when a physician goes on vacation, takes a sabbatical or leave of absence, leaves the United States, or is otherwise unavailable to his or her patients, the physician must arrange to provide his or her patients access to their medical records. This requirement could be challenging for physicians in

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solo practice. Finally, the Proposed Rule continues the existing requirement that “physicians charging for the cost of reproduction of medical records should give primary consideration to the ethical and professional duties owed to other physicians and their patients, and waive copying charges when appropriate.” Medical Record Retention

The Proposed Rule states that medical records shall be retained for a period of not less than seven years from the physician’s (and/or other providers within his or her practice) last professional contact with the patient, with a few exceptions discussed below. Currently, there are no State laws generally addressing the retention period for medical records and some medical practices may currently retain records for less than the proposed sevenyear period based on the shorter Alabama statute of limitations time-frame for filing a medical malpractice lawsuit. The Proposed Rule sets out four specific exceptions to the seven-year retention requirement. First, immunization records which have not been transmitted to the immunization registry maintained by the Alabama State

Board of Health must be retained for a period of not less than two years after the patient reaches the age of majority (age 19 in Alabama) or seven years from the date of the physician’s (and/or other providers within his or her practice) last professional contact with the patient, whichever is longer. Second, X-rays, radiographs and other imaging studies must be retained for at least five years from the date of the study, after which if there exist separate interpretive records thereof, the imaging studies may be destroyed. However, mammography imaging and reports must be maintained for ten years. Third, medical records of minors must be retained for a period of not less than two years after the minor reaches the age of majority or seven years from the date of the physician’s (and/or other providers within his or her practice) last professional contact with the patient, whichever is longer. Finally, no medical record involving services which are under dispute shall be destroyed until the dispute is resolved, so long as the physician has formal notice of the dispute prior to the expiration of the applicable retention period. The (CONTINUED ON PAGE 11)

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Sweeping Medical Record Changes Proposed, continued from page 10 Proposed Rule does not define the term “dispute”, but a reasonable interpretation is any legal action involving the applicable medical record or any related government or third-party investigation. Destruction of Medical Records

The Proposed Rule requires that a physician have an established policy for destruction of medical records and that medical records should only be destroyed in the ordinary course in accordance with such policy and applicable state and federal laws. Records may be destroyed by burning, shredding, permanently deleting or other effective methods in keeping with the confidential nature of the records. When medical records are destroyed, the physician or the physician’s practice must keep written documentation of the time, date and circumstances of the destruction and such documentation must be maintained for not less than four years. The record of destruction need not list the individual patient medical records that were destroyed but must sufficiently identify which “group of destroyed records contained a particular patient’s medical records.” The intent of this last requirement is subject to interpretation, and it is recommended that a list of destroyed records by patient name (or by last date of service) be maintained, if possible. Patient Notification

The death, retirement, license suspension or revocation, departure of a physician from a medical practice or sale of a medical practice all require that the applicable physician’s “active patients” be notified of the triggering event. Active patients are defined in the Proposed Rule as any patient treated by the physician “one or more times during the immediately preceding thirty-six (36) months” prior to the event that necessitates patient notification. The Proposed Rule states that patient notification shall at a minimum identify: (1) the physician who treated the patient, (2) the general reason for the patient being notified, (3) an explanation of how the patient may obtain a copy of his or her medical records, (4) a HIPAA authorization for the patient to complete and return, (5) how long the medical records will be made available to the patient, and (6) the intended disposition of the medical records if no instructions are received from the patient within the time provided. Notification may be sent by U.S. Mail to active patients at their last known address. Further, notification can be through an electronic message sent in compliance with HIPAA or HIPAA-compliant electronic health record system that provides a means of electronic communication to the patient and is capable of sending the patient a notification that a message is in the patient’s portal. Death of a Physician. If notification is due

to the death of a physician, the Proposed Rule provides that notification shall be sent by the physician’s practice, if applicable, within thirty days following the death of the physician. If the physician is in solo practice, the notice must be sent by the personal representative of the physician’s estate within thirty days of appointment of an executor or administrator by the Probate Court. The party sending the notice shall bear the cost of notifying the physician’s active patients. Of note, for physicians who are in solo practice, the physician must include compliance with the Proposed Rule (once finalized) as part of his or her estate planning. Physician Retirement. If notification is due

to a physician’s retirement, the physician, if in solo practice, or the physician’s group practice, as applicable, is responsible for sending a notification to the physician’s active patients not less than thirty days prior to retirement. The retiring physician must take reasonable steps for all medical records to be transferred to the custody of his or her active patients, to another physician, or to a HIPAAcompliant entity that agrees in writing to act as custodian of the records. If a custodian is used, it is recommended that the parties enter into a written medical records custodian agreement to specifically delineate the custodian’s responsibilities under HIPAA and state law.

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Licensure Action. Under the Proposed

Rule, a physician’s active patients must be notified of a suspension or revocation of the physician’s license. The notice must be sent by the affected physician or his or her medical practice within thirty days following imposition of the suspension or revocation. The cost of sending the notification is the responsibility of the physician whose license is suspended or revoked and the notification must contain a copy of the Medical Licensure Commission’s Order of Suspension or Revocation. Further, the affected physician must take reasonable steps for all medical records to be maintained or transferred either to the custody of the physician’s active patients, to another physician, the physician’s medical practice, or to a HIPAA-compliant entity that agrees in writing to act as custodian of the records.

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Leaving a Medical Practice. If a physician

leaves a medical practice (other than for retirement), the Proposed Rule states that the responsibility for notifying active patients and paying for the cost of the notification is governed by the physician’s employment or other agreement with the medical practice. Absent a contractual provision to the contrary, when the medical practice undertakes to notify patients of the physician’s departure, the practice shall bear the cost of notification and reproducing or transferring medical records. If, however, no con(CONTINUED ON PAGE 12)

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The OIG’s Updated Healthcare Fraud Self Disclosure Protocol, continued from page 8 FROM

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to resolve potential Stark law violations. Only one of the two protocols should be used. If the disclosed arrangement involves a potential violation of only the AKS or of both the AKS and the Stark law, the disclosing entity should utilize the OIG’s SDP. If the arrangement only implicates a potential violation of the Stark law, the arrangement should be disclosed to CMS using its SRDP. The OIG’s general practice is to require a minimum multiplier of 1.5 times single damages, although it may determine that a higher multiplier is appropriate. Generally, the OIG applies the multiplier to the amount paid by healthcare programs, not the amount claimed. For self-disclosures involving potential violations of the AKS, the OIG will require a minimum settlement amount of $100,000, which is consistent with its statutory authority to impose a penalty of up to $100,000 for each transaction. For other matters accepted into the SDP, a minimum settlement amount of $20,000 will be required by the OIG. This amount was set to be consistent with the OIG’s authority to impose a CMP of $20,000 for each improper claim submitted under the CMP law. If a disclosing entity thinks that it cannot pay a proposed settlement amount, the OIG will require the entity to submit

extensive financial information, including audited financial statements, tax returns, asset records, etc. The inability to pay a proposed settlement should be disclosed to the OIG as early as possible during the self-disclosure process. In the event that the entity has previously refunded as an overpayment a portion of the calculated damages, the refunded amount will be credited against the total damages. When making a submission under the SDP, disclosing entities should identify anything in the submission that it believes to constitute trade secrets or to be privileged and confidential, and therefore exempt from disclosure under the Freedom of Information Act. The OIG will make a reasonable effort to notify the disclosing entity prior to releasing information that has been identified as trade secrets or privileged and confidential. Where a healthcare provider believes that its conduct may rise to the level of potential fraud involving federal healthcare programs, self-disclosure under the OIG’s SDP should be carefully considered. When used properly, the SDP can serve to reduce the provider’s liability to the government and promote a timely resolution of the matter. James F. Henry is a partner with Phelps where he specializes in healthcare law.

Pharmacogenomics a Valuable Tool in Clinical Care, continued from page 3 inform drug therapy in the future. The Centers for Medicare & Medicaid Services broadly covers pharmacogenomics for all valid indications. “For example, if your physician prescribes a new anti-depressant, he can order a pharmacogenetic test to select which anti-depressant is most likely to work for

you. Currently, about 10 to 15 percent of the drugs on the market have pharmacogenetic guidance,” Limdi says. “As more research is done, more evidence will develop. There will be more guidelines for more medications that will allow precision medicine for multiple conditions for the individual patient.”

Sweeping Medical Record Changes Proposed, continued from page 10 tractual provision exists and the medical practice elects not to notify active patients, then the departing physician shall be responsible for the cost of notification and reproducing or transmitting medical records. When the departing physician is responsible for notifying patients, the practice must provide the physician a list of his or her active patients and their last known mailing address and contact information. In general, absent a contractual provision to the contrary, the party who notifies the active patients of a physician’s departure is responsible for the costs of notification and reproducing or transferring medical records. Sale of a Medical Practice. The Proposed Rule recognizes that medical records may be part of the assets sold to a buyer of a medical practice. In that situation, the selling physician, his or her estate, or medical practice, as applicable, must take reasonable steps to transfer all medical records to

another physician or HIPAA “covered entity” or HIPAA “business associate” operating on the buyer’s behalf. All active patients must be notified within thirty days of the transfer and given the opportunity to have their records sent to another physician, the patient, or the patient’s representative. Notwithstanding the above, the purchase of equity in a medical practice (i.e., stock in a P.C. or Inc. or membership units in an LLC) that continues to operate, and which does not constitute the sale of the entire practice, is not considered a “sale” for purposes of the Proposed Rule. This exception would apply when a physician is admitted as a new owner of a medical practice. Howard Bogard is a Partner at Burr & Forman LLP and chairs the firm’s Health Care Practice Group. He can be reached at hbogard@burr. com or at 205-458-5416.


Hospital chaplains Serve a Vital role in Treating the Whole Patient By Marti Webb Slay

requests a visit from the chaplain, Patients enter the sometimes a phyhospital for specific sician will make medical reasons, but the request. Ryan they also come with Humphreys, MD, their own unique set Rev. Sonya Gravlee, M.Div., an emergency phyRev. Rodney Franklin, D. of personal needs that chaplain at Ascension St. Min., staff chaplain at UAB sician at Ascension Vincent’s East have an impact on their St. Vincent’s East, care and recovery. Hospital chaplains can makes those requests fairly often. play a key role in addressing these needs “The chaplains offer an extension and providing another dimension of care of what I do,” he said. “I can give pills for patients and their families. and do procedures, but at the end of the “I see my role as being a bridge of day, human beings have souls. The guy spiritual support for the patient and famwho trained me said once, ‘there are very ily,” said the Rev. Rodney Franklin, D. few sacred moments in life. In those moMin., staff chaplain at UAB. “They can ments, everything has to stop.’ I can adbe unfamiliar with the system, and they dress the medical side of it, but in those are overwhelmed. They are often anxious sacred moments, patients need someone and bring personal issues with them in adto comfort a soul that is being crushed. I dition to their medical diagnosis. We protake that to heart, and in moments like vide spiritual support to help calm them that, I call them in.” and focus on why they are there. We can While the chaplains seek to provide help them get through the maze as they comfort and counsel for patients, they seek to come out whole.” also want hospital staff to know they are Many patients have resources they available for them as well. may not be aware of. The Rev. Sonya “With COVID, we are now spendGravlee, M.Div., chaplain at Ascension ing a lot of time with people who work St. Vincent’s East, said, “Our charge is to here,” Gravlee said. “The trauma has afoffer support to patients who are sick, but fected all of us. People are doing the best to also help them draw on the spiritual or they can, but the best they can do now is emotional resources they already have so not necessarily the best they could do two their healing is not just physical, but also years ago. If I think of myself as a pastor, spiritual and emotional. We can initiate my parish is the people who work here. relationships of care and help identify If I build my relationships with them, support in and out of the hospital. they involve me more in caring for their “Sometimes we talk to patients about patients. It’s doctors and nurses, but also grief. In my experience, many people with people who clean the hospital and serve chronic conditions also have grief they in the cafeteria as well as administrators.” have carried for a long time, and they may “I have always been available to feel guilty about still carrying it. That’s just hospital staff, but because of COVID, one more thing that affects their physical I’m now more intentional about checkhealth because they may not have ever ing on them,” Franklin said. “They have processed it. I call it ‘making space for to deal with the heaviness of patients grief ’ because it really never goes away.” who come in and don’t have a positive Chaplains are often called in after outcome. I affirm to the staff that they a family has had a ‘goals of care’ conare doing a great job. I also encourage versation with the doctor, when the them to take time to refuel themselves.” outcome will lead to death. “We assist Humphreys has an open relationship patients when doctors have done all with the chaplain in the Emergency Dethey can. We support them during this partment, and in January 2021, he asked time by accompanying them and their for more involvement with his staff from families until they have taken their last the Spiritual Care Department. “I told her breath,” Franklin said. Chaplains can my people are hurting and demoralized,” also help facilitate getting advanced dihe said. “We are all going to have some rectives/living wills and identifying paelement of traumatic stress. I asked her to tient advocates when needed. come to the Emergency Department more While the chaplains may pray with often. Now she comes and talks with us. It’s patients and provide a Bible or Koran or nice to have someone to have a conversaother religious literature upon request, tion with. They are there to support us.” they do not proselytize. “It’s important He encourages his colleagues in to be mindful of the patient and meet other hospitals to rely on their own chapthem at their point of need,” Franklin lains when it’s necessary. “There may be said. “Each patient is different.” a fear that the chaplain will get into their Gravlee agreed. “It takes a lot of business, but the chaplains I know are just listening to determine what is going to there to support us. Don’t be afraid to be help them,” she said. bitten by some spiritual bug. They are While it may be the patient who just there to be human with you.”

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so that rural facilities can deliver subspecialized care to patients near their home.

GRAND ROUNDS

Wallace Named Community Star of the Year Eric Wallace, MD, medical director of Telehealth at UAB Hospital and an associate professor in the UAB Division of Nephrology, has been Eric Wallace, MD named the 2021 Community Star of Alabama by the National Organization of State Offices of Rural Health for his efforts in developing telehealth services to increase access to health care in rural communities. Small towns in Alabama have lacked access to subspecialty care for many years. Until recently, patients in need of nephrology, infectious disease, critical care or neurology services, among others, would be transferred to an urban hospital for care. Wallace identified this problem and in 2016, he became the first physician in the country to replace an in-person doctor/patient visit with a telehealth visit for home dialysis. That successful first-ofits-kind appointment led to the creation of a secondary line of service, one that would provide access to subspecialty care for thousands of rural Alabamians. Since that beginning, Wallace and his team have established dozens of partnerships, networking with providers to create a telehealth system that includes UAB, along with three other hospitals, engaging in tele-nephrology, as well as 14 other hospitals for telehealth,

Grandview Cancer Center First in State to Earn NPF Designation Grandview Cancer Center has been recognized as an approved National Pancreas Foundation (NPF) Center by the National Pancreas Foundation. NPF Centers are awarded after a review to determine that an institution is focused on multidisciplinary treatment of pancreatic cancer, treating the whole patient with a focus on the best possible outcomes and an improved quality of life. “We are honored that Grandview Cancer Center is the first center in Alabama to be designated as a NPF Center for treatment of pancreatic cancer,” said Daniel McKinney, CEO of Grandview Medical Center.

Brimer Joins Cullman Regional Medical Group Thomas Cameron Brimer, MD has joined the Cullman Regional Medical Group. Brimer, who practices internal medicine, earned his medical degree at the University of South Ala- Thomas Cameron Brimer, MD bama College of Medicine and completed his residency at the University of South Florida Department of Internal Medicine. While in residency, he served on the University of South Florida Department of Internal Medi-

cine Leadership Council (2019-2020) and served as Resident Champion for Patient Experience (2019-2020). In addition to caring for patients, Brimer volunteers with Habitat for Humanity, Relay for Life, Toys for Tots and St. Jude’s Research Hospital.

UAB Nursing Undergraduate Degree Ranked 10th Nationwide

Alabama Allergy & Asthma Center Joins AllerVie Health The physician owners of Alabama Allergy & Asthma Center and the Clinical Research Center of Alabama have partnered with an investment group and have received an infusion of growth capital leading to the creation of AllerVie Health, a national network of board-certified allergists and immunologists. All Alabama Allergy & Asthma Center locations have rebranded to AllerVie Health. Weily Soong, MD and the other providers at Alabama Allergy maintain a meaningful ownership portion of the business. They continue to practice medicine, providing services to patients from the current 10 locations across the state. “We chose to go with an equity partner because our allergists are passionate about changing the face of allergy, asthma, and immunology care in this country,” Soong said. “We believe that the public demand is high for innovative healthcare, great customer service, and increased access to these services, and AllerVie Health is poised to be the premier solution in this country for the millions of Americans affected annually.”

UAB School of Nursing

The UAB School of Nursing undergraduate nursing degree has ranked among the best programs of its kind by U.S. News & World Report in its list of 2022 Best Colleges Rankings. The program was rated 10th nationwide out of more than 694 programs. This list was based on peer review from deans and senior faculty members across the country. “UAB School of Nursing programs always strive for quality and excellence as we prepare highly educated nurses to deliver and lead nursing and health care in these challenging times,” said Dean and Fay B. Ireland Endowed Chair in Nursing Doreen C. Harper, PhD, RN, FAAN.

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Birmingham Medical News


Medical West Breaks Ground on Replacement Facility

Cullman Regional Opens Imaging Center

GRAND ROUNDS

EDITOR & PUBLISHER Steve Spencer VICE PRESiDENT OF OPERATIONS Jason Irvin CREATIVE DIRECTOR Katy Barrett-Alley CONTRIBUTING WRITERS Cara Clark, Ann DeBellis, Jane Ehrhardt, Laura Freeman, Cindy Sanders, Marty Slay Birmingham Medical News 270 Doug Baker Boulevard, Suite 700-400, 35242 205.215.7110 Ad Sales: Jason Irvin, 205.249.7244

The Imaging Center at Hartselle Health Park

Artist’s rendering of the new facility to be built along I-459.

Cullman Regional has opened an Imaging Center at Hartselle Health Park. Located alongside the newly opened urgent care center at 1549 Hwy 31, the imaging center offers onsite diagnostic imaging services including x-ray, 3D mammography and MRI. Ultrasound and CT services will be added at a later date. “Access to healthcare is vital for communities like Hartselle,” said James Clements, Cullman Regional CEO. “We’re proud of Hartselle Health Park and the medical services it offers. We believe Morgan County residents deserve convenient, quality care from providers they can trust.”

On November 17th, Medical West Hospital, an affiliate of the UAB Health System, broke ground on its new facility that will replace the current aging hospital following the completion of construction in 2024. The new facility will include a 412,000 square foot, nine-story hospital with 200 beds and a 127,000 square foot, five-story medical office building. The facility, a full-service hospital, will feature a new surgical suite with 12 operating rooms, state-of-the-art imaging technology, more intensive care beds and robotic surgery capacity. Serving Bessemer, Hueytown, Vance, Tannehill, Parkwest, and Hoover, Medical West has over 1,100 employees and more than 250 physicians on its medical staff, and in combination with the Medical West Freestanding Emergency Department, the hospital sees over75,000 visits annually.

A new healthcare approach.

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Birmingham Medical News

DECEMBER 2021 • 15


Your heart health can’t wait. High blood pressure is called the “silent killer” as most of the time it does not show any obvious symptoms, yet it can put you at risk for serious heart problems and other health conditions. At Cardiovascular Associates, we will help you learn your risk of heart disease, set goals, and gain control of your health.

Manage your heart disease risk. Call 855.93.HEART to schedule a heart screening. Scan the code and book an appointment online today. CVAPC.com 16 • DECEMBER 2021

Birmingham Medical News