Birmingham Medical News April 2023

Birmingham-based Molecular Designs Opens Cutting-Edge Facility

By MArti WeBB slAy

When Molecular Designs and Streamline Scientific co-founders Ty Thomas, MD and Chad Austin, MD established their first lab, it was based on a desire to better serve the patients in their medical practice.

“We started our own physician office lab in 2012,” Austin said. “We were frustrated with the lab market and wanted to could eliminate the time gap. We thought if we figured out how to do it ourselves, we could cut time, provide better patient care, and end up saving money. It turned out we could actually make money doing it.”

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Endoscopic Spine Surgery Reaches Birmingham

By JAne eHrHArDt

Endoscopic spine surgery (ESS) has been around for decades in other parts of the world, but still lingers in its infancy in America. “If you travel to Europe— especially Germany or southeast Asia, Japan—endoscopic decompressions and discectomies are almost the gold standard,” says Daniel Kim, MD, spine surgeon with Southlake Orthopaedics and one of the first to be performing the procedure in Alabama.

The slow introduction of ESS to the U.S. likely stems from the fact that much of the development of the technique occurred in other countries. In addition, U.S. doctors are not being trained for it coming out of fellowship, and it is not something readily picked up. “Since it’s a completely different way to do

spine surgery, it’s very difficult for even more experienced surgeons to just adopt it right off hand,” Kim says, who has performed over 30 procedures in the last 18 months.

Endoscopy takes minimally invasive spine surgery to its most advanced, state-of-the-art form to produce a quicker recovery time and less recurring pain for the patient. It differs from minimally invasive, micro-invasive, and laser spine surgeries. “All the work that you do at the structures of interest within the spinal canal is the same,” Kim says. “The difference is all in the collateral damage that’s required to do the job itself.”

The entry is a mere eight millimeters for endoscopy versus two or five centimeters for tubular and

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Daniel Kim, MD performs ESS.

Molecular Designs is located in Perimeter Park.

The facilities are ISO-certified.

Children’s of Alabama Fights the Youth Mental Health Crisis

ByAnsley FrAnco

Five years ago, the Children’s of Alabama hospital opened the Psychiatric Intake Response Center (PIRC), a confidential phone center to help adult callers find mental health resources for children and adolescents. Since March 2018, the PIRC has grown from just four employees to 14 part-time and full-time employees now.

According to The Assistant Secretary for Planning and Evaluation studies, there has been an increase in children’s mental health needs following social isolation due to the pandemic, especially among children who experience adverse childhood experiences.

“Right now, we are seeing kids in such a crisis that they are thinking about harming themselves and are experiencing suicidal feelings,” said Cynthia Jones, Director of the Psychiatric Intake Response Center. “And much of that, I think, has been driven by the fact that there has been so much disruption to children’s lives, and that is primarily because of the pandemic. We’ve had children who had these issues prior to the pandemic. So, it’s not like all the sudden the pandemic caused it, but it certainly exacerbated what is an underlying concern about children’s mental health.”

In 2017, after a search team from Children’s of Alabama visited three psychiatric intake centers in Ohio and Colorado, Jones said the group felt that a program like this would best meet the needs of the communities in Alabama. “The reason for that is because these programs were helping anyone in the community identify and find the most appropriate mental health resources, and a lot of people were at a loss for what to do once they find out their child has a mental health concern,” she said.

When an adult calls in, they speak to a licensed mental health professional who will conduct a brief questionnaire to determine the issues concerning their child. The PIRC therapist will then access the database of mental health providers they think would be the best solution for the situation.

Over the past five years, the database has grown from 250 providers in central Alabama to more than 1,600 across the state. “Our team continues to add and update providers in the community. This is actually public knowledge. We’re not providing any information that you couldn’t find online or by calling these practices,” Jones said. “We are not endorsing anyone. We simply hope we can take down some of the barriers by identifying available mental health providers, and offering what we think would be the best resource in their community for their

child to get help.”

The therapists not only answer the phone and provide resources but also see the patients who come into the Emergency Department as part of the psychiatric consult team. The team is composed of the Medical Director, nurse practitioners, physician assistants and licensed mental health professionals.

“We felt like we needed that level of qualified therapists in order to better understand the needs of our callers, and be

able to not only find the right resources, but to also educate and answer questions they have about what’s going on with their child,” Jones said. “We’ve found that parents have been relieved to speak to someone knowledgeable about mental health concerns for children and adolescents, educate them, and point them in the right direction. We are able to help families avoid a crisis because they are taking steps ahead of time before a problem turns into an emergency.”

This PIRC is not a crisis or suicide hotline, though Jones said some adults have called in after a child has done something that gives them concern or has expressed suicidal thoughts. In circumstances like this, PIRC therapists advise the family to take the child to the nearest emergency room to receive treatment. As the PIRC continues to provide this service to the community, Jones hopes people will gain greater access to mental health care.

A provider listens to a parent’s concerns.

Psychiatric Intake Response Center therapist.

Eventually they founded Assurance Scientific Laboratories, which has recently rebranded as Streamline Scientific and Molecular Designs. They have just moved most of their operations into a new state-of-the-art facility in Birmingham’s Perimeter Park. The rapid growth and success of their efforts meant they had their choice of locations when they moved, but they opted to stay in Birmingham.

“It wasn’t guaranteed that this would stay here,” Austin said. “We have clients throughout the country, and there were discussions to move. But we didn’t want to. We had to sell Birmingham to our investors. We told them that Birmingham has great talent. It’s a great medical community, a great biotech community, and a great place to live.”

“Board members were largely unfamiliar with all Birmingham has to offer, and we said ‘look at what we’ve built here. Look at UAB. We can be headquartered here,’” said Shawn Hood, president. “Today, we collectively see the full value and potential of Birmingham, its talent base, and vast resources.”

“I’m really excited about the facility,” Austin said. “It was fun to design and build.”

The new location boasts over 7,000 square feet of space for CLIA lab, manufacturing, and research and development,

in addition to a 25,000-square-foot distribution facility. Those spaces are now ISO-certified, and include clean room manufacturing, three negative pressure R&D laboratories, six high-speed Tecan filler machines, and 500 square feet of cold chain storage. The companies currently employ approximately 130 people.

It’s quite a change from the humble beginnings of starting the lab in their medical practice. After taking two years to establish that lab, Thomas and Austin had a skill set they wanted to share. “We realized there was a gap in the market and wondered why it was so hard to do this,” Austin said. “We felt we could offer a consulting service for physicians who wanted to establish a lab in their own practice by developing what we could and outsourcing what we could, while the physician only had to deal with one person. That didn’t exist in the lab world.”

Now branded Streamline Scientific, the company will equip and optimize an existing lab or establish a new lab. Or physicians can avail themselves of the Streamline Scientific lab and often get results within 24 hours.

But the services don’t end there. They not only work with physicians, but other labs as well. “If another reference lab, even a competitor to Streamline, wants to bring on some new tests, we can help them. We can help them buy the

equipment and get it running,” Austin said. “We have our own lab, so we’ve experienced all the problems our clients are going to have.”

They offer more than advice, however. “We also design, develop, and make tests to sell to other labs,” Austin said. That work falls under the scope of Molecular Designs.

“Molecular Designs looks at what new lab tests we can offer,” Hood said. “And manufacturing our own ingredients helps from a cost standpoint. Other labs are buying their ingredients from large manufacturers. We believe we set ourselves apart because we can provide better service and be more flexible. If we can provide those things and be more competitive on the price, then that’s why they come to us.”

The goals of the two companies support each other. Molecular Designs sells product to over 150 labs around the country, even as Streamline Scientific helps set up labs and runs lab work from its original Acton Road location. “Since CLIA lab uses our product every day, we know our product inside and out. If any problems come up, we’re going to know first. It’s a kind of downstream quality control. We also find out from our reps on the ground what the doctors want,” Hood said. “It helps our research and development to know what we should be

working on next.”

They already have a plan in that regard. “Infectious disease is our primary space right now, so we are going to continue to finish out the panels most desired in that space,” Austin said. “We are expanding into GI. We also have plans to get into cancer tests. COVID has expanded PCR technology. Our expertise in PCR allows us to do some tests in a much more affordable way. That’s a direction we are moving next. We want to continue making quality products that are easier to use, and to run them on a smaller platform and make them cost effective.”

With the opening of the new facility, it’s clear both companies will maintain their headquarters in Birmingham, while they continue to expand.

“Most people wouldn’t expect to find this in Perimeter Park,” Hood said. “This is in Birmingham and available to our physicians. It’s in their backyard. Our private equity partners said we needed a world-class facility that local employees would want to work at, and that when anyone from across the US comes to look at it, they would be impressed. I think we’ve accomplished that.”

The Streamline

At Streamline Scientific we provide fast and reliable diagnostic testing using PCR and traditional microbiology to identify specific pathogens. This arms clinicians with the data needed to prescribe the most appropriate treatment.

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Endoscopic Spine Surgery Reaches

Birmingham, continued from page 1

open portals, respectively. To reach the surgical site with the pencil-wide trocar, the surgeon enters with an intralaminar approach from the back of the spine between two laminae or the transforaminal entry from the side of the spine into the neuroforamen—a nerve passageway.

A tiny camera then inserts through the trocar and projects real-time images of the site onto a monitor in the surgeon’s direct view. “The visualization is some of the best you can have, even as opposed to a microscope because you are looking directly at the nerves, the disc, and the bony structures,” Kim says. Though the detail with the zoom function on some microscopes can match the endoscopic view, the field of view becomes very limited when using the zoom.

Once the surgeon reaches the site, the procedure mimics tubular and open surgeries for discectomies and decompressions. The tools also remain the same, but they are specially sized to fit through the small working channel.

“The freedom of motion is much less, because you’re using a single instrument through a tiny portal, so you have to learn how to navigate the equipment,” Kim says. “You can’t move the same in there because the reach is only a few centimeters from one side to the other. So you better be in the right vicinity and the right angle when you come in. That’s part of the steep learning curve with all of this.”

That learning curve grows if the surgeon chooses the transforaminal approach. “Anatomically everything looks flipped then,” Kim says, for surgeons who use the more straight-in, intralaminar entry utilized in the open and tubular options. “This is why it’s so hard to learn. It’s a whole new surgery.”

However, the small incision and smaller tools mean less trauma to the ligaments, bone, and joints—the stabilizing

features of the spine—leading to a faster recovery. “There are problems that used to take weeks to months of recovery reduced to days with endoscopy,” Kim says. Most ESS procedures can be completed in about one hour with patients able to be back on their feet just a few hours after post-operative recovery.

The limitation in site access with endoscopy, though, does limit the types of procedures possible and patient candidates. ESS is not suitable for revision surgery, cases of clear spinal instability, high-grade spondylolisthesis, or cancer. Kim is also not performing fusions at this time.

Longer-term outcomes for a nerve compression problem performed using any of the three options of open, tubular, and endoscopic spine surgery appear to be similar. But the short-term recovery does differ because of far less trauma caused while reaching the surgical site. “The journey matters just as much as the end result,” Kim says. “If we can provide patients with a more comfortable and more functional recovery, that matters too.”

The entry and wound incision area is 8 mm for endoscopy verses 2 or 5 cm for tubular and open portals.

Daniel Kim, MD

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Carter Monitors Feasibility of PCR Testing vs. Urine Cultures for UTIs

By MArti WeBB slAy

With the increase of PCR testing during the COVID pandemic, the use of PCR tests vs. antigen tests vs. cultures is being reexamined, with questions about the balance between speed and accuracy, and which tests are reimbursed by insurance and which are not.

Dan Carter, MD, pediatrician and lab medical director at Greenvale Pediatrics Hoover, is watching the debates about the options and when to order which type of test in the changing landscape.

For UTI infections, for instance, cultures are still the gold standard and the only test most insurance plans cover. “With a culture, within about five days you know exactly what bacteria it is and the antibiotics that work effectively against it,” he said. “But a PCR test looks at the genetic makeup of the bacteria, and based on the history of that genetic makeup, they are able to determine what its sensitivities will be and what its characteristics are. It’s not a better test; it’s a much faster test. The time difference is between several days for a culture to grow and receiving PCR results within about 12 hours. That can be critical for the very young and very old with a UTI.”

Very few insurance plans cover PCR testing for UTI infections, however. “It’s controversial, because when you are testing the old-fashioned way, there is never a false result,” Carter said. “Using genetics to test is trickier. They make assumptions that because the genetic material matches a certain bacteria, it’s going to have certain characteristic in how it relates to antibiotics.”

Carter likens PCR tests to fingerprints. The doctor has to know what bacteria to test for. If a UTI is caused by e. coli, a common culprit, a physician can test for that and proceed with treatment quickly. If the UTI is caused by a less common bacteria, it may not show up on the requested PCR tests.

Carter said that uncertainty is scary to physicians and insurance companies, and the nephrology community has not been quick to embrace the technology. The gastroenterology community has begun to make use of it, however.

“For some reason, in GI, PCR testing is being reimbursed better,” he said. “In our practice, we are utilizing the GI panels a lot, because we have a lot of children with diarrhea, and we can get results back in 12 to 24 hours, which can

Dan Carter, MD

really change the course of their illness. We can stop something that would have been a three-week diarrheal course and change it to a three or four-day course. Diarrhea is still the biggest killer in the world, so PCR technology is a big deal. It’s terrific for GI. We’ve seen success in GI, and I think there could be success in the urine world.”

It’s a balance of accuracy vs. time. “If you are looking for one thing specifically — one virus, one cause of a urinary tract infection – PCR is always going to be accurate,” Carter said. “But if you are looking for a broad possibility of infections, PCR is difficult because you can only test one at a time. Culture is always going to be more accurate, because it will catch everything, but PCR, in certain infections, hopes to be as accurate with a much faster speed. PCR testing will never become more accurate than culture. That’s not its goal and purpose. Its purpose is speed.

“In a mild urinary tract infection, without fever, there’s probably no benefit to PCR. In terms of rescuing lives, PCR really matters with pyelonephritis.”

Carter predicts advances in the future that will make PCR testing even more effective. “I hope that one day not too far in the future, you don’t have to specify what you are looking for,” he said. “You can run a test that actually identifies DNA without needing to type it in. Right now it only looks for what you designate it to look for. There could come a day when you put in a substance and it tells you what DNA is present, without you having to type in the parameters. I think by the time the selfdriving car is around, the self-driving test will be too.”

In the meantime, Carter is keeping an eye on advancements in PCR tests and using it when financially feasible for his patients. “We are waiting for more uniform coverage before we offer it for UTIs.”

Finding the Right Housing Match MMP offers

personal service for relocating physician families

By lynne Jeter

On any given day, especially after Residency Match Day, Amanda Baron may pick up transferring physicians from the airport, have welcome baskets waiting at their hotel with local goodies, give them a tour of the area and help them with relocation.

Across the country, the scenario is repeated by select realtors who are married to physicians and understand the specifics needed for a successful move via Moving Medicine Partners (MMP), a national network of professional realtors that specialize in physician and family relocations.

“Our agents have been there, done that,” said Baron, whose husband, Chris Baron, MD, is a pediatric interventional radiologist at Vanderbilt Children’s Hospital in Nashville. “In addition to finding a home, we help these newcomers get connected to their communities from the very beginning. We know how important that is.”

Baron, a realtor for Compass Real Estate in Nashville, led the effort to create a network by seeking other professional real estate agents within Compass, a real estate brokerage company with more than 25,000 agents nationwide. Zoe Cangas, a realtor at the St. Louis location, helped Baron find the original dozen MMP members, then set

the managing teams, which ultimately resulted in an ally team.

The founding members hashed out details at a luncheon at the annual Compass Retreat last August. By the end of February, MMP had 45 realtors representing numerous states, including Alaska and Hawaii.

“Our goal is to have all states represented,” Baron said. “We’ve had an overwhelming response from realtors across the U.S., wanting to join the MMP team. While we’re still interviewing applicants, we’ve had close to 60 interviews in the first two months of

the year.

“Having first-hand experience of being ‘married to medicine’ helps our agents connect to physician families on a different level. We understand the lifestyle and demands put on the family to make moving that much more stressful. We have systems in place to help connect the physician family to other agents nationally and feel at home right away.”

Baron moved from Texas to Tennessee 18 years ago for her husband’s residency.

“He had no time off to come look

at houses, so my mom and I came with a three-month-old baby,” she said. “We looked Friday, Saturday, and Sunday. I bought a house on Sunday, and he never saw it until we moved.

“I try to help my clients with this challenge. Many times, they must do things virtually or I’m dealing with the spouse. I try to streamline as much as I possibly can.”

MMP is expecting a rush of business after Match Day by helping on both ends to make a smooth transition.

Last year, nearly 47,675 applicants registered in the Main Residency Match, according to the National Resident Matching Program.

“When residents receive their respective ‘match,’ there’s a short window of time to leave one area and report to the next seamlessly, generally state to state,” Baron said. “We offer immediate help. We can connect them to an agent in their area to make their moves seamless. We can also help with rental properties if that better fits their needs.”

Many realtors in MMP also belong to local, regional, and national chapters of American Medical Association-Alliance for spouses.

“Connecting into the medical community is very important,” Baron said. “They have instant friends and support. My husband had to do a fellowship in Cincinnati while I lived in Nashville with our then five-year-old and threeyear-old. Having a good support system is what carried me through.”

The Birmingham MMP realtor is Debi Mestre, who is the owner of MD Realty. Her daughter Susan, who earned a Nurse Practitioner from Vanderbilt, and her son Adam, who earned a law degree from the University of Alabama, both work with her. Her husband, Jose Mestre, MD, is a gastroenterologist with Children’s of Alabama.

Debi Mestre started her career as a nurse, before becoming a CPA, then an attorney, and finally a realtor. The vast majority of her client base is physician families, from Residents to Departmental Chairs.

Amanda Baron

(Left to right) Debi Mestre, Adam Mestre, Susan Dressler

The USDOJ Continues to Increase Its Fraud Enforcement Actions Related To COVID-19 Relief Benefits

By JiM Hoover

Fraud enforcement actions by the United States Department of Justice (USDOJ) continue to rise against companies and individuals related to their applications for and receipt of COVID-19 benefits. It appears that no type of entity is exempt from these enforcement actions. For example, as recently as March 21, 2023 the USDOJ announced a settlement with two Florida companies, Kingwood Orlando Reunion Resort LLC (Orlando Reunion) and Kingwood Crystal River Resort Corp. (Crystal River). Orlando and Crystal River agreed to pay $325,000 to settle allegations that they violated the False Claims Act (FCA) and the Financial Institutions Reform, Recovery and Enforcement Act (FIRREA) by providing false information in support of the Paycheck Protection Program (PPP) loan forgiveness application submitted by Crystal River. Orlando Reunion and Crystal River, which are related but operate separate resorts, both received separate PPP loans. The United States alleged that Crystal River sought forgiveness of its PPP loan, in-part, by certifying that it used a portion of its PPP loan to pay wages of Crystal River employees, when in fact, some of the employees to whom it claimed to have paid wages were actually Orlando Reunion employees whom Crystal River did not employ or pay. As a part of the settlement, Crystal River and Orlando Reunion agreed to pay $271,720 in damages under the FCA and $53,280 in civil monetary penalties under FIRREA.

The settlement resolved a lawsuit filed under the qui tam or whistleblower provision of the FCA, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The qui tam lawsuit was filed by the former Director of Human Resources for Kingwood resorts who will receive a total of approximately $46,000 in connection with the settlement.

This latest settlement continues to exemplify the USDOJ’s trend of COVID-19 fraud enforcement and encouraging whistleblowers to file FCA

actions. The former Principal Deputy Assistant Attorney General Ethan Davis called the FCA “one of the most effective weapons in our arsenal” to combat fraud perpetrated against the government. This is because relators can receive between 15 to 30 percent of a successful FCA action, plus their attorneys’ fees. FCA cases provide for up to treble damages to the United States as well as civil monetary penalties of up to $25,000 per claim.

Over the past year, FCA activity in the COVID-19 arena has picked up significantly. On March 13, 2023, the USDOJ announced a settlement with two Michigan nonprofit organizations to settle allegations that the organizations violated the FCA by applying for and obtaining loans under the PPP for which they knew or should have known they were not eligible. In connection with the settlement, one charity paid $115,265 and the other paid $110,622 notwithstanding the fact both companies repaid their loan proceeds in full in December 2020.

Also, an Albany, New York-based nonprofit agreed to pay $86,676 in damages and civil monetary penalties to resolve allegations that it violated the FCA by obtaining an inflated PPP loan.

Additionally, on February 1, 2023 the USDOJ announced a settlement with three California companies that agreed to pay a total of $530,000 to settle allegations that they violated the FCA and the FIRREA by knowingly submitting false information in support of their PPP loan applications. A bakery in Palo Alto agreed to pay $430,000 to settle allegations that it received and retained a duplicate PPP loan in 2020 and then later improperly sought and received forgiveness for the duplicate loan. Meanwhile, an industrial equipment supplier located in Santa Clara agreed to pay $50,000 in civil penalties to settle allegations that it received and retained a duplicate loan, and a licensed general contractor located in Castro Valley agreed to pay $50,000 in civil damages and penalties to settle allegations that it received and retained proceeds from a duplicate loan. Two of the companies

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Katie Bean, MD

Dr. Katie Bean grew up in Pell City and graduated cum laude in Physics from Auburn University. After receiving her medical degree from the University of South Alabama, she completed both her residency in Internal Medicine and fellowship in Nephrology at Virginia Commonwealth University. Dr. Bean then returned to Birmingham as an assistant professor at UAB before joining Nephrology Associates in 2023. She is board certified in Internal Medicine and Nephrology, and is a member of the American Society of Nephrology.

Jim Hoover

Physician-driven, Patient-centered Kidney Care

By tHoMAs WAtson, MD

There have been amazing medical advances in recent years – a non-smoking acquaintance in his 40’s was diagnosed with lung cancer several years ago, and instead of a life expectancy of six months, he is living comfortably taking a pill designed for his cancer, for which he had a genetic predisposition. We’ve seen these breakthroughs in many fields of medicine, but unfortunately, advancements in treatment for patients with kidney disease have lagged behind.

Due to the cost and complexity of care of kidney disease patients, one area of innovation in which kidney disease care is becoming a proving ground is care delivery. Patients with chronic kidney disease are generally medically complex, with higher rates of heart disease, cancer, and even gastrointestinal bleeding than the general population. They have significant care coordination needs focused on preventing worsening of kidney disease, preparation for kidney transplant, and unfortunately preparation for dialysis

when appropriate.

All of these facets of care require extensive education. There are many appointments required with various specialists at many different facilities (for which patients require something as simple as transportation). Patients with kidney disease often require extensive and complex medication regimens. Hard-working nephrologists cannot provide all of this support alone, and deficiencies in care lead to worse outcomes for patients, increased hospitalizations, and greater cost to the healthcare system as a whole.

CMS and private insurance companies are acutely aware of these problems. As a result of a combination of the Affordable Care Act of 2010 and the Executive Order Advancing American Kidney Health of 2019, in addition to a change in eligibility for Medicare Advantage plans for patients with End-Stage Kidney Disease (ESKD), we now have an opportunity to partner with both CMS and private insurers to make radical changes to our care delivery models in an

for what’s

effort to increase education and care for patients with kidney disease – and doing so should lower costs.

There are a number of healthcare companies attempting to provide some of these services via care management systems run primarily by nurses and other support staff, often remotely, and rarely in partnership with a patient’s physician.

As we all know, Value-Based care is the popular phrase for this delivery model, but I prefer a less catchy, but more accurate phrase: Physician-driven, patient-centered care. It is physician-driven because nephrologists will be taking responsibility and financial risk for every facet of their patients’ care. It is patient-centered because every medical decision we make in partnership with our patients will be guided only by what is best for those individual patients. I would like to think that all of us as physicians have always made decisions for patients based only on what is best for them – but in a fee-for-service system, we must all recognize that distorted incentives exist that can affect care.

Along with 16 other practices nationwide, our practice has partnered with Evergreen Nephrology to provide physiciandriven patient-centered care to our patients.

Over the next few years, we expect to provide these expanded services to a majority of our ESKD and advanced CKD patients. We will be doing home visits, providing mental health support services where needed, addressing transportation limitations, education and patient engagement, food insecurity, early support and education for transplant services, medication review and education, just to name a few facets of care. Using data analytics, we will access all of a patient’s available electronic health information and leverage that predictive modeling to identify and intervene on the highest-risk patients to make their lives better. We will be focused on disease prevention and stabilization to reduce the number of patients who are forced to start dialysis or undergo transplantation. For those who worsen despite our best efforts, we will be helping to coordinate kidney transplantation when possible – hopefully before a patient ever needs dialysis. For those who are forced to start dialysis, we will be focused on Home Dialysis modalities which have equivalent outcomes to standard incenter dialysis, but much better quality of life scores at a lower overall cost.

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Thomas Watson, MD

DEA Proposes New Telehealth Prescribing Rules

By sHAnnon Britton HArtsFielD AnD nili yolin

The COVID-19 public health emergency (PHE) is set to expire on May 11, 2023, and there seems to be a scramble to extend some of the pandemic-related flexibilities involving telehealth. The U.S. Drug Enforcement Administration (DEA) recently released two notices of proposed rulemaking to allow some of those flexibilities to continue, but the proposed rules are nevertheless more restrictive than what has been permitted since the PHE went into effect. One proposed rule will no longer permit telehealth providers to prescribe controlled substances if the patient never had an in-person examination, subject to limited exceptions. Another proposed rule would expand the situations where doctors may prescribe buprenorphine, used in pain and withdrawal management.

Telehealth Prescribing of Controlled Substances

Pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Act), which serves as the basis for

the proposed rules, unless one of seven exceptions applies, controlled substances may not be distributed online without a valid prescription. Additionally, a provider must conduct at least one in-person patient visit before prescribing a controlled substance over the internet. The failure to conduct an in-person examination constitutes a violation of the Controlled Substances Act and carries potential civil and criminal penalties. When the PHE went into effect in 2020, the DEA suspended the in-person exam requirement and allowed pro-

viders to prescribe controlled substances via telehealth as long as the prescription was for legitimate medical purposes and the prescribing practitioner was acting in accordance with applicable federal and state laws.

Under the proposed rule, Schedule II controlled substances such as Ritalin, Adderall and Vicodin and Schedule III-V narcotics other than buprenorphine may not be prescribed to patients without an in-person evaluation. Providers would be able to prescribe a 30-day supply for buprenorphine and non-narcotic Schedule

III-V drugs such as Xanax and Ambien without an in-person visit if the telemedicine encounter is for a legitimate medical purpose. Anything beyond a 30-day supply will require an in-person visit. If a patient had already been receiving prescriptions by telemedicine during the PHE, the DEA will defer the in-person exam requirement for an additional 180 days.

Prescribing Buprenorphine for Opioid Use Disorder

Balancing the safety measures imposed by the Act with the need to expand access to certain narcotics, the DEA wants to expand access to buprenorphine due to the substantial increase in fatal drug poisonings involving illegal synthetic drugs. The proposed rule would allow authorized providers to prescribe buprenorphine for use in the treatment of opioid use disorder (OUD) via telemedicine, including through an encounter that is audio-only. According to the DEA, the amount of fentanyl seized in 2022 is enough “to supply a potentially lethal dose to every member of the U.S. population.” The proposed rule would

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Erika Issis Vasha, PA-C Jessica Ramos, DO Jeremy Dornier, MD Orthopedics Family Medicine Family

Nili Yolin

Shannon Britton Hartsfield:

Relax. Recover. Regain.

The USDOJ Continues to Increase Its Fraud Enforcement Actions Related To

COVID-19 Relief Benefits,

also agreed to fully repay their loans as part of the settlements.

As is evident from enforcement actions in other industries, COVID-19 FCA enforcement actions are now another theory of recovery against health care companies and individuals. As with other theories of FCA recovery, health care companies must remain vigilant to maintain their compliance with local and federal rules and regulations, and ensure

Let our luxurious surroundings soften your road to recovery

The resort-like amenities at Aspire will create a soothing environment for your rehab stay. Our licensed physical therapists will work with you personally to restore your strength and ability.

Our facility boasts the latest in rehabilitation options, including two state-of-the-art gyms with specialized equipment to get you back in action. Our ceiling-mounted Zero Gravity System suspends patients for secure guidance to get you on your feet faster. Our therapists utilize the latest Omni Virtual Reality System to stimulate progressive therapy through walking, jogging, and other movements. We also have recovery services for hip and knee replacements, plus strength and conditioning programs following rheumatologic conditions.

continued from page 11

they actively follow an effective compliance program. This involves proactively identifying and mitigating risks including reviewing COVID-19 initial loan applications, benefits they may have received and any loan forgiveness applications.

Jim Hoover is a health care trial and compliance Partner at Burr & Forman LLP practicing exclusively in the firm’s health care group. Jim may be reached by telephone at (205) 458-5111 or by E-mail at jhoover@burr.com.

Physician-driven, Patient-centered Kidney Care,

continued from page 12

It is an exciting time in nephrology as a result of these care delivery innovations. Our programs began for a small number of patients on January 1, and we hope to increase those numbers dramatically over the next several years. I feel certain that

our efforts will yield happier and healthier lives for our patients, and I can’t wait to see to see the results.

Thomas Watson, MD practices with Nephrology Associates. He is Board-Certified in Nephrology and Internal Medicine by the American Board of Internal Medicine.

DEA Proposes New Telehealth Prescribing Rules,

continued from page 13

increase access to buprenorphine and lower the risk of death.

Misuse of buprenorphine can also lead to death, however. The Act allows prescribing of controlled substances through the internet for legitimate medical conditions even without an in-person evaluation as long as the drugs have been approved for maintenance or withdrawal management treatment of OUD and the telemedicine practitioner can conduct a bona fide patient evaluation. Buprenorphine is currently the only Schedule III-V narcotic that is FDA-approved for use in continuous medical treatment or detoxification for patients with OUD. The rule would allow prescribing through audioonly encounters if the patient is unable to or does not wish to use audio/video technology. The proposed rules contain guardrails against diversion, however, including a requirement that practitioners review and consider Prescription Drug Monitoring Program (PDMP) data prior to prescribing buprenorphine so that a patient engaging in drug-seeking behavior does not receive multiple prescriptions. Additionally, patients would either have to be examined in person by the prescriber within 30 days, or the prescriber would have to examine the patient remotely while the patient is in the physical presence of another DEA-registered practitioner participating in a synchronous audio-video telemedicine encounter with the prescriber.

Other key provisions in the proposed rules include the following:

• This rule would not affect prescriptions of drugs that are not controlled substances.

• The prescriptions would also have to be consistent with state law.

• Practitioners would have to keep records of all qualifying telemedicine referrals, and such records would need to be kept at the registered location that is listed on the prescriber’s certificate of registration.

• Prescriptions stemming from telemedicine encounters could be only for the purpose of maintenance or detoxification.

Although the proposed rules offer a reprieve to the potential abrupt end to telehealth prescribing of controlled substances, many industry stakeholders, including the American Telemedicine Association, have expressed concern that they are more restrictive than necessary to address the DEA’s concerns regarding potentially harmful and abusive prescribing practices while dealing with an opioid epidemic. If the proposed rules are not changed, only time will tell whether they have a positive or negative impact on patient care, including patients struggling with OUD. Importantly, however, state law largely governs remote prescribing and should not be overlooked when evaluating telemedicine requirements.

Shannon Britton Hartsfield and Nili Yolin, who practice in Florida and New York, respectively, are partners at Holland & Knight LLP, where they advise healthcare providers on compliance issues involving federal and state healthcare laws and regulations.

Let Aspire’s resort-like atmosphere be a part of your rehab experience.

Postless Minimally Invasive Hip Arthroscopy Reduces Risk of Complications

By lAurA FreeMAn

As an alternative to open surgery, minimally invasive hip arthroscopy has greatly advanced the repair of hip injuries. However, the need to gain access by using a post for counter traction to distract the joint and hold the leg in place for an extended period can result in pressure injuries. Tissue damage can range from hematomas to full-blown pressure necrosis and may involve the scrotum or labia majora.

“The ball and socket joint in the hip is very deep. It takes a great deal of force and skill to distract it safely,” Aaron J. Casp, MD said. An assistant professor of orthopedic surgery in the division of sports medicine at UAB’s Heersink School of Medicine, Casp is one of the first surgeons in the region who performs a new postless hip arthroscopy procedure.

“Over the past year we’ve been using a new technique that eliminates the need for the traditional post setup,” he said. “During the procedure the patient lies on a traction bed and we position a device similar to a memory foam pad along the inner side of the leg. This allows us to distribute the force over the full length of the device, which reduces the pressure on any one area.”

The surgeon makes two small incisions to introduce the arthroscope and a 70 degree camera. In addition to preoperative MRI imaging, the camera allows visualization of the joint and injury as well as cartilage fragments, chips and other debris that may be responsible for symptoms.

“Labrum tears are the most frequent injury we see,” Casp said. “Many of our patients are athletes ranging in age from high school to 45. The injuries tend to occur during sports or other leisure or work activities. Motions that cause hyperflexion or an acute twist or pivot of the join can cause tears. Repetitive use can

also cause extra bone to build up on the ball side and lead to problems.

“Arthroscopy allows good visualization, so we can see exactly what is going on and what we need to do to repair the joint and ease symptoms. We repair tears by using suture anchors to bring the labrum up on the bone. Then we remove any debris that might be a problem and reshape the bone if needed.”

Usually an outpatient procedure, postless hip arthroscopy patients can go home the same day. They will typically be on crutches for around four weeks and are usually released to return to their favorite sports and activities in about five months.

Postless arthroscopy can also be used to help patients over the age of 45, however excessive cartilage damage that may have built up over time could limit the results that can be expected.

“When cartilage damage is extensive, I may have to advise an older patient that they could be facing a hip replacement in the future,” Casp said.

Based at UAB’s Heersink School of Medicine, Casp performs the procedure at UAB and St. Vincent’s surgery center. The new approach offers definite advantages in reduced risk of pressure injuries. As of now, the postless option is so new that Casp is among the few, if not the only surgeon in the area, who performs it, and referrals are coming in from across the region.

“There’s a long learning curve for this procedure,” he said. “It’s very technical, uses some new, longer instruments and requires a lot of practice to become adept. However, several of my students are surgical residents who are working with me and learning the postless hip arthroscopy procedure. It should soon become a more widely available option to help many more patients.”

CORRECTION

In the article titled Why Isn’t Lumbar Disk Replacement Covered in Alabama? on page six in the March Birmingham Medical News, we incorrectly said that Mark Prevost II, MD was a spine surgeon with Southlake Orthopaedics. Dr. Prevost is actually in practice with Precision Sports Medicine- SOSA Jasper.

We apologize for the mistake.

When people with extraordinary talent and passion are given the technology, the facilities, and the support, they achieve great things. The discoveries taking place today will help shape the future of treatments and lead to cures – benefitting not only our patients and families, but people across the country and around the world for years to come.

Aaron J. Casp MD

Mark Prevost II, MD

Law Enforcement Exception to HIPAA: What Providers Need to Know

By AnDy BAer, MD

Healthcare providers are well-versed in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and the broad protection it offers to patient information held by healthcare providers and plans.

However, they might not be as aware of key exceptions to the rule — one of them being requests for protected health information (PHI) from state and local police and other law enforcement agencies.

A healthcare professional or practice may receive a verbal or written request for PHI or copies of medical records

from law enforcement officials as part of an investigation. For example, they may be following up on suspected child abuse or investigating an altercation that resulted in a crime. It’s important that healthcare organizations understand how to appropriately respond to such a request to avoid a HIPAA violation and the associated fines.

HIPAA Law Enforcement Exception Defined

The HIPAA Privacy Rule exception for law enforcement purposes, 45 CFR § 164.512(f), permits a covered entity (generally, healthcare providers, health

plans and their business associates) to disclose PHI to law enforcement officials without patient authorization under certain circumstances:

• If a court order, court-ordered warrant, subpoena or administrative request has been issued

• To identify or locate a suspect, fugitive, material witness or missing person

• To answer a law enforcement official’s request for information about a victim or suspected victim of a crime

• To alert law enforcement of a person’s death if the organization suspects that criminal activity caused the death

• When an organization believes that

CARING FOR ALL YOUR ORTHOPEDIC NEEDS

PHI is evidence of a crime that occurred on its premises

• In a medical emergency not occurring on the organization’s premises, when it’s necessary to inform law enforcement about the commission and nature of a crime, the location of the crime or crime victims, and the perpetrator of the crime.

The definition of law enforcement official is broad and applies to an officer or employee (state or federal) who investigates or conducts an official inquiry into a potential violation of law. It also applies to law enforcement officials who prosecute or otherwise conduct a criminal, civil or administrative proceeding arising from an alleged violation of law. Examples of law enforcement officials include officers, investigators or detectives from a sheriff’s office, the FBI, and state detectives or investigators.

Responding to a Records Request

Alabama Bone & Joint is committed to medical excellence and pledges the highest quality of orthopedic care available. Our physicians and support staff provide all of our patients with professional orthopedic care delivered efficiently and on a personal level.

If a law enforcement official sends a letter requesting records, the letter will likely describe where to send the requested records in addition to providing the law enforcement official’s contact information. Many times, the cover letter or request will not copy the other party because the investigation is sensitive or confidential.

Law enforcement officials also may verbally request PHI or copies of medical records from a healthcare organization either over the phone or in person. If a law enforcement official comes to an organization’s office in uniform and provides proper identification, then it is appropriate to produce the PHI.

However, if the request is made over the phone, a healthcare organization is required to obtain further verification before releasing PHI. Ask the caller to provide a formal request in writing and cite the requestor’s source of statutory authority under state or federal law. The request can be made on official letterhead or by email if the message includes the source of authority and is sent from the official’s work email address.

Healthcare organizations generally do not have to obtain an individual’s written authorization before disclosing PHI if they receive an appropriate written or verbal request from a law enforcement official. However, if the official is requesting the PHI of an adult patient who is a victim of abuse, an organization usually must obtain authorization from the patient before disclosing anything to law enforcement.

Preparing Your Practice to Comply

Communication and training are key to making sure a healthcare practice complies with the law enforcement

ON PAGE 17)

Loy Vaughan, M.D.

S. Evan Carstensen M.D Daryl Dykes, M.D. Michael C. Gerhardt, M.D. Lloyd Johnson Ill, M.D.

Winston Capel, M.D.

UAB Callahan Opens Homewood Clinic

In February, UAB Callahan Eye opened a clinic in Homewood with its newest provider, John Owen, MD, who has practiced in Homewood for over 15 years. The clinic, which is in the Regions Building, is the 19th clinic location in Callahan’s growing portfolio of ophthalmic and optometric care.

coma screenings, cornea diagnosis and treatment, and contact lens evaluations. All Callahan patients are also eligible to receive a minimum 15 percent discount on all sunglasses and eyeglasses at the on-site optical store.

“Callahan has a wonderful team of eye care specialists, and I am thrilled to join this enhanced continuity of care in an expanded network of services,” Owen said.

Richardson of Mobile, who was first diagnosed with ALS in 2019 and began seeing UAB physicians a few months later. “If I have questions or need any information, they are there to help. The more you interact with your care team, the better you are able to express how the disease is affecting you.”

John Owen, MD

“We are always looking to provide convenient access to care for our patients, and we are excited about this new clinic,” said Rett Grover, UAB Callahan Eye’s chief executive officer.

Patients who visit the clinic will receive services including family eye care, eye exams, cataract evaluations, glau-

Law Enforcement Exception to HIPAA,

continued from page 16

exception (and all other HIPAA requirements). The following actions can help an organization remain compliant.

• Conduct annual HIPAA training for staff members that includes information regarding Privacy Rule exceptions.

• Establish a process for flagging and handling medical record requests from law enforcement.

• Implement a checklist with the steps necessary to respond to medical record requests from law enforcement.

• When unsure about the legitimacy of a request, contact the law enforcement office involved, ensure that it made the request and clarify the reason for it.

• Share only the patient records requested and nothing more.

• Transmit records in a HIPAAcompliant manner.

The wrongful release of patient health information to law enforcement doesn’t happen often. However, if a healthcare organization inappropriately discloses PHI, it could face a HIPAA violation and the associated fines. Understanding the law enforcement exception to the HIPAA Privacy Rule and implementing processes to answer requests are key to responding appropriately and avoiding penalties.

Disclaimer: The information provided in this article does not constitute legal, medical or any other professional advice. No attorney-client relationship is created and you should not act or refrain from acting on the basis of any content included in this article without seeking legal or other professional advice.

Andy Baer, MD serves as the Chief Medical Officer of MagMutual.

To schedule an appointment, call or text 844-UAB-EYES.

UAB’s New ALS Clinic

A new clinic for amyotrophic lateral sclerosis (ALS) at the University of Alabama at Birmingham lets patients see eight healthcare providers during a single visit, with a single co-pay.

“They’ve got my back,” said Venus

The new clinic is supported by a grant from the Alabama Department of Commerce Innovation Fund. It allowed UAB to expand the existing clinic to see more patients more often. Most patients will come every three months, and during their visit, they will meet with their neurologist, physical and occupational therapists, a dietitian, speech therapist, psychologist, social workers, and respiratory therapists. The visit is facilitated by a nurse coordinator who has several years of experience with ALS patients.

“It helps the patient to be able to see all of their care providers at one

Practice like the Pros

visit,” said clinic co-director Mohamed Kazamel, MD, associate professor in the Department of Neurology, Marnix E. Heersink School of Medicine. “It allows the care team to work together to build a comprehensive care program for each patient paired with frequent follow-up.”

The new clinic opened in January. It sees about 150 patients currently and expects to add about 30 new patients each year.

“Beyond expanding our clinical services, the Alabama Innovation Fund grant will allow us to hire an ALS clinical trials coordinator so that we can participate in trials that shed new light on the disease,” said Nan Jiang, MD, PhD, associate professor of neurology and codirector of the clinic.

For more information on the UAB ALS clinic, call 205-934-2120.

Endoscopic Spine Surgery.

Michael F. Blum, M.D. | Ekkehard Bonatz, M.D. | George Robert Booker, M.D. William S. Craig, M.D. | Michael T. Ellerbusch, M.D. | Richard L. “Beau” Grantier, M.D. | Christopher

Heck, M.D. Jonathan Isbell, M.D. | Dewey H. Jones, M.D. | John S. Kirchner, M.D. | William D. Krauss, D.O. Michael D. Smith, M.D. | William D. Sudduth, M.D. | C.J. Talbert, M.D.

Alabama MGMA Winter Conference

UAB Names New Leaders

organizational financial health and strategic financial decision-making. Prior to joining UAB, she spent 21 years with Ascension Health in Birmingham, serving in several financial roles that culminated as vice president of Seton Health Corporation. She is a certified public accountant and was formerly with KPMG.

‘Odds Are Alabama’ Shines Light on Dangers of Fentanyl

The University of Alabama at Birmingham Health System has named Brenda Carlisle as chief executive officer of UAB Hospital, and Susan Jennings as chief financial officer for the Health System. Both had been serving in their respective roles in an interim capacity.

Before assuming the position as interim CEO in November 2022, Carlisle had been vice president of Clinical Operations for UAB Hospital since 2017. Prior to joining UAB, she was chief operating officer, vice president of Patient Care Services and vice president of Operations at Brookwood Medical Center in Birmingham. She began her career as a registered nurse and has over 30 years of experience in nursing management and health care operations throughout Alabama and Florida.

Jennings has over 35 years’ experience within the health care industry serving in a variety of roles focused on

The Odds are that if you buy pills or other illicit drugs online or from a dealer, they will be laced with a deadly dose of Fentanyl. According to a 2022 DEA study, six out of 10 fake pills seized by the DEA contained Fentanyl. These were some of the facts highlighted to-

The Alabama Medical Group Management Association (MGMA) held their Winter Conference at the Birmingham Hyatt Regency from Wednesday, March 1st to Friday, March 3rd.

The opening day included breakout sessions for a number of specialties in order to discuss issues specific to specialty. It included Orthopedics, OB/ GYN, Primary Care, Cardiology, Der-

day by several statewide organizations announcing the launch of Odds Are Alabama, a campaign to bring awareness to Alabamians on the dangers and prevalence of illicit Fentanyl.

Odds Are Alabama will heighten awareness of the dangers, and provide information regarding help for people with substance use disorders, along with information about medication that can reverse an overdose and strips to test drugs for Fentanyl.

According to the DEA, Illicit drug manufacturers are lacing other drugs like cocaine and marijuana with Fentanyl and manufacturing fake pills that

The Alabama MGMA Board: Greg Hulsey, Todd Ledford, Tamekia Buchanon, Thalia Baker, Amy Fisher, Samantha Wiseman, Tony Palazzo, Lisa Beard.

matology, ENT, Oncology, Pediatrics, Pulmonary, Allergy, and Surgery.

The following days gave attendees choices of sessions with professionals, including Maddox Casey, CPA of Warren Averett, who spoke about strategic planning; Kim Huey on Incident-to and Split/Shared Services; and Janet Day, MBA, CMPE who talked about no surprise billing.

include the drug to ensure that users are hooked on the first try. Because a lethal dose of Fentanyl is only about two milligrams, equivalent to a few grains of salt, it’s becoming increasingly common for users to overdose.

“The surge of illicit Fentanyl is driving overdose deaths to their highest level ever,” said Julia Boothe, MD, president of the Medical Association of the State of Alabama. “Fake pills containing Fentanyl are everywhere in Alabama. They look identical to real medicine, but you won’t know until it’s too late.”

For more information visit www. OddsAreAlabama.org.

Left to Right: Brenda Carlisle and Susan Jennings.

Mark Jackson, Executive Director of MASA, speaks for Odds are Alabama.

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Grandview Opens FSED in Trussville

Grandview Medical Center held ribbon cutting ceremony on April 4th for the new Freestanding Emergency Department (FSED), opening in Trussville. The 12,500 square foot facility is the first of its kind in the Trussville community and provides patients with another option for 24/7 emergency services in the region.

The new FSED is located at 5542 Vanlerberghe Lane, just off Highway 11. It will include nine exam rooms, Fast Track rooms, on-site lab services, diagnostic imaging for X-ray, CT, and ultrasound. There is also a heliport on site. Emergency physicians, registered nurses and other patient care professionals will staff the ER.

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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Artist rendering of new Grandview FSED.