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A discussion of potential opportunities and legal risks that physicians and medical aesthetics business owners should be aware of going into the second half of 2024 and beyond.

Medical aesthetic services: a host of opportunities and legal uncertainties

If properly structured, a medispa business presents an opportunity for physicians to increase recurring practice revenue, some of which may be generated by non-physicians.

What physicians need to know before opening a medispa

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are emerging as a medical breakthrough in the treatment of obesity.

Some of the people most excited for them are doctors who counsel patients on metabolic bariatric surgical treatments, and the surgeons who perform those procedures.

Proponents say metabolic bariatric surgery to reduce the size of the stomach remains a valid treatment that is vastly underutilized, even misunderstood, in contemporary American medicine and health care. The new medications are not about to put them out of business, they said.

“People ask that question: Is bariatric surgery going to become obsolete? We also get asked the question: Does lifestyle change become obsolete? Do we not need to worry about diets anymore?” said Kristina Henderson Lewis, M.D., M.P.H., S.M., and associate professor of epidemiology and prevention at Wake Forest University School of Medicine.

“I think the answer to both of those is no,” Lewis said. “If anything, it makes me more excited about the outcomes that we can expect to achieve with lifestyle interventions and bariatric surgery.”

Once the U.S. Food and Drug Administration approved the GLP-1 RA drugs for obesity management, in 2022 and 2023, there was a noticeable change in U.S. health care. Comparing the second half of 2022 with the second half of 2023, GLP-1 RA drug prescriptions shot up 132.6%. The number of patients undergoing metabolic bariatric surgery dropped 25.6%, according to “Metabolic Bariatric Surgery in the Era of GLP-1 Receptor Agonists for Obesity Management,” published in 

Is that the beginning of the end of bariatric surgery? Or the beginning of a new era of therapy?

“I think the way to think about this is from a different direction, and from the patient’s perspective, that this is almost the golden age of treatment for obesity,” said study corresponding author Thomas C. Tsai, M.D., M.P.H., a metabolic bariatric surgeon in the Department of Surgery at Brigham and Women’s Hospital in Massachusetts. “Really, it’s about how we take all the different treatment options we have and use that multidisciplinary approach to meet the overall health goals of patients.”

The time has come for obesity specialist physicians to borrow concepts from oncologists and cancer treatments, Tsai said. GLP-1RA drugs can be neoadjuvant or adjuvant treatments combined with a form of surgery that remains a gold standard treatment with the highest degree of total body weight loss, and with the most data showing long-term effectiveness.

“Really, the thinking is moved from thinking of, what is the best treatment at any given time? To thinking about, what is the best treatment course for a patient over the life cycle of what effectively is a chronic disease?” Tsai said.

That study had another telling finding, he said. Even with the shift from surgery to pharmacologic management, fewer than 6% of patients with obesity in the commercially insured population actually were treated with best-in-class medications or best-in-class surgical procedures. Only about 1% of patients who met indications for it were undergoing the procedures at a given year, Tsai said.

While those percentages are small, there is a large number of Americans dealing with obesity and overweight. The drugs are effective, but the surgeries can help people lose up to 35% of their body weight, said Caroline Apovian, M.D., FACP, FTOS, DABOM, co-director of the center for weight management and wellness at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School.

“How many people are we talking about in the United States?” she said. “Well, BMI over 40 has grown four-fold since 1960. This is about maybe seven to 10 million Amercians. Yes, those people can be helped by our new medications, but a good proportion of those people can be helped even more by bariatric surgery.”

 published “Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial.” The study found “substantial, sustained weight loss,” approximately 15% of body weight, for adults with obesity or with overweight and at least one weight-related comorbidity. It was part of a steady stream of reports about the new miracle drugs melting away body mass.

The same month, there was another medical development, with perhaps less attention. The American Society for Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) published their new “Guidelines on Indications for Metabolic and Bariatric Surgery – 2022.”

They replaced a consensus statement developed by the National Institutes of Health in 1991. The new guidelines were long overdue, said ASMBS President Ann Rogers, M.D., FACS, FASMBS, DABS-FPMBS, director of the surgical weight loss program at Penn State University. She credited ASMBS past president Shanu N. Kothari, M.D., for pressing the specialty for new standards of care.

“It just says something about the stigma of obesity, because we have new treatments for all sorts of things like breast cancer and colon cancer and – you name a disease, and we have something much newer than 1991,” Rogers said.

Then, the surgeries were open. The first laparoscopic metabolic bariatric surgery was done later in the 1990s. Now they are minimally invasive, and moving toward robot-assisted, with safety rates on par with or better than operations such as gall bladder removal, hernia repair or knee replacement, Rogers and Tsai said.

Some insurance companies have embraced the new standards, some have not, Rogers said. “But for patients, I think it’s opened the door for a lot of people to realize that they have this disease,” she said.

Rogers, who has performed thousands of metabolic bariatric surgeries, described current trends in the patient experience with the procedure and with insurance.

Worldwide, metabolic bariatric surgery patients tend to be approximately 80% women. Most commercial insurance plans will cover bariatric surgery, Rogers said, as long as patients spend a certain amount of time or make a minimum number of physician visits in a preparation program. There is nutritional education, and insurers may or may not pay for visits with a dietitian. Some will require cardiology or pulmonary evaluations, a sleep study, or other tests. Some insurers mandate patients not gain weight during the program – not even one pound, she said.

“I mean, we jump through all sorts of hoops so that patients can get authorization for the surgery,” Rogers said. “There’s just a bunch of nonsense, really, that is not based in science.”

Patients have encountered insurance company “headwinds” in covering the new GLP-1 RA drugs. The same resistance has existed for years about paying for metabolic bariatric surgery, Tsai said.

“There really needs to be a societal conversation about, how do we increase access for life-saving medications like GLP-1s and life-saving treatments like metabolic and bariatric surgery for patients, so they can really benefit from the significant amount of medical innovation that’s happened over the last several decades,” he said.

Once the programs start, bariatric surgical patients become some of the best-informed surgical patients that doctors will meet, Rogers said. They get to know about nutrition, the surgical procedure itself, and potential complications. Many of them have friends or relatives who also had the surgery, so the potential patients ask them questions about their experiences, she said.

Worldwide, the programs tend to have a dropout rate of approximately 50%, Rogers said. But for the other half, eventually it is time to pick a date and the type of procedure. ASMBS estimated in 2019, almost 60% of the surgeries were sleeve gastrectomies, approximately 18% were gastric bypass, and there are other variations.

“By far the most common question is, what should I do? And I like that – thank you for not coming in with a preformed opinion,” Rogers said.

But there are expectations. Many patients will talk a good game about wanting to improve their diabetes or another health condition.

“They may not state that overtly, but everybody comes in expecting to lose a lot of weight, and then if everything else gets better, so much the better,” Rogers said.

While it’s impossible to predict exact effects, research suggests that will happen, and it’s possible to talk about averages. For example, men tend to lose more weight faster than women – often a point of annoyance for wives who undergo counseling and surgery together with their husbands, Rogers said.

Then begins long-term follow-up. Many patients, now invested and grateful, go on to live healthier and longer lives. They also revere their surgeons, Rogers added.

Primary care physicians not familiar with current practice may be living in the past, when the procedures were viewed as ill-advised, even dangerous, Rogers said.

“I would love to have people listen and believe that this is a very safe set of operations,” she said. “People continue to believe that bariatric surgery is rash and it should be the last possible choice. No, it’s conventional therapy.”

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs have significantly impacted obesity treatment, leading to a rise in prescriptions and a decline in bariatric surgeries. Despite this, experts argue that bariatric surgery remains a crucial, underutilized option, offering substantial weight loss and long-term effectiveness. The integration of GLP-1 RAs as adjunctive therapies could enhance treatment outcomes. However, access to both medications and surgeries is hindered by insurance barriers. Updated guidelines and increased awareness may improve patient access and acceptance of these life-saving interventions.

Proponents say the surgical procedures are underutilized and misunderstood in contemporary medicine.

Topics

Weight Management

The Weight Loss Drug Revolution: GLP-1 RA drugs inspire new excitement for metabolic bariatric surgeons

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs have made headlines for helping patients with type 2 diabetes, obesity and potentially a host of other medical conditions.

It is clear the antiobesity medicines are working. Patients want them. And they are not always willing to wait for their physicians to prescribe the new remedies.

How likely are patients to skip their doctor’s orders and go shopping online for pharmaceuticals? In a fall 2024 survey by 

, 78% of respondents said they were concerned about their patients attempting to procure GLP-1 RAs from online sources without their knowledge.

But that leaves patients vulnerable to online rip-offs or worse –– getting drugs that are inappropriate or even harmful. With the U.S. Food and Drug Administration (FDA) pronouncing the drugs in shortage, compounding pharmacies have stepped in to fill the void, but that may cloud the situation, not clarify it.

“Patients are very confused about where they get the product. Where is it legal to buy it? How easy is it to get it? What’s a compounding pharmacy versus the product coming from the legitimate manufacturer, like Eli Lilly or Novo Nordisk?” said Tim K. Mackey, Ph.D., who has studied online fraud as a professor of anthropology at the University of California San Diego.

“I think it’s very challenging for the average consumer to navigate all of this and understand it,” he said.

Mackey is the corresponding author of the study “Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases,” published last year in 

, which analyzed the validity of online sales of semaglutide. Tenille Davis, Pharm.D., is a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding (APC). Rob Nichols, Pharm.D., BCPS, is director of clinical operations for the Greenwood Pharmacy and Compounding Center of Waterloo, Iowa. They spoke with 

 about the state of the GLP-1 RA marketplace as of late 2024.

The drugs have a strong record for treating type 2 diabetes but are relatively new for weight loss, and people like novelty. Word has spread that celebrities are using the medicines to drop weight and keep it off, with great results.

There are regular reports in the popular and scientific media about successful studies and more discoveries of other health benefits. There are some instances of extreme side effects, but apart from gastrointestinal upset, the medicines generally are safe.

Demand is skyrocketing. But the drugs are expensive, so people are looking for cheaper sources.

The FDA says the drugs are in short supply, opening the door for compounding pharmacies to make substitutes.

Telehealth blossomed during the COVID-19 pandemic, so patients have been consulting with doctors electronically. Along with the GLP-1 RA news reports, smartphones are ubiquitous in a nation of consumers who are comfortable shopping online.

In this situation, it is not easy for doctors to counsel patients on obtaining GLP-1 RAs, the experts said.

“Public health surveillance shouldn’t necessarily be the responsibility of physicians. They’re there to care for their patients,” Mackey said. Most physicians and medical students are not trained in safety issues that intersect with technology, he noted.

“But at the same time, these consumers are really, really interested in these products, and if you just say, ‘Well, you don’t need it, so we’re not going to prescribe it to you,’ you may be missing an opportunity to educate a patient about the potential risk of them sourcing it from another place,” Mackey said.

Prescription needed –– and let the buyer beware

First and foremost, GLP-1 RA medications are prescription drugs. Remind patients that they need a prescription to obtain them. Patients who try to get around that could lose money or get a product that is inappropriate for them, worthless or, even worse, harmful.

In Mackey’s study, he and colleagues in the United States and Hungary bought nonprescription semaglutide from six sources online. Three sent Ozempic injections that likely did not meet legitimate product quality standards. As for the other three, “Not only did they send us nothing, they tried to scam us out of more money by saying that we had to pay customs fees associated with getting the product imported into one of our testing sites,” Mackey said.

Online scam sites can be fairly sophisticated in design. Yet they can be identified, and platforms that host them could take them down easily, “but they may need encouragement through some sort of direct regulation or incentive to do the right thing because it’s not always required based upon the policies we have today,” Mackey continued.

Confusion abounds in the market when news media conflate illegal online drug sellers and legitimate compounding pharmacies that are supplying GLP-1 RA drugs, Davis said.

The situation goes beyond mere name-calling, even beyond billions of dollars in pharmaceutical sales: Human lives may be at risk. In fall 2024, Novo Nordisk CEO Lars Fruergaard Jørgensen cited FDA records when he told CNN that compounded versions of semaglutide were associated with at least 100 hospitalizations and 10 patient deaths. APC countered with its own issue brief, “Compounded GLP-1 Drugs and Patient Adverse Events,” picking apart his claims and asserting the importance of legitimate pharmacies.

Pharmacists mixing drug formulas started long before pharmaceutical giants began mass producing big bottles of pills or injections, Davis said.

“Compounding pharmacists have been helping to create medications for patients that need them,” Davis said. “Everything was created from scratch, essentially. So it’s been around for hundreds and hundreds of years, the traditional practice of pharmacy, and we existed far before GLP-1 drugs.”

When an FDA-approved medication is on the FDA’s shortage list, compounding pharmacies are legally authorized to create essentially a copy of that medication, Davis said.

Drug shortages can last for years. By autumn 2024, that was the case with semaglutide – in shortage since March 2022 – and tirzepatide – in shortage since December 2022. The FDA rulings on availability created time for a huge telehealth industry to spring up around compounded GLP-1 RA drugs, she said.

Davis acknowledged that compounded drugs are not the first choice for doctors and patients. Price can’t be a reason to choose compounded drugs, which often are not covered by insurance, she said. “That being said, in general, compounded GLP-1s are typically much less expensive than the commercial GLP-1 drugs,” because the pharmacies don’t have the research or operating costs of Big Pharma, she added.

However, the ability to sell compounded GLP-1s will soon be limited. The FDA announced on Dec. 19 that these drug shortages have ended, and the agency has issued new guidelines. Under these new guidelines, state-licensed pharmacies must cease compounding, distributing or dispensing tirzepatide injections by Feb. 18. Outsourcing facilities must do the same by March 1.

Kristina Henderson Lewis, M.D., M.P.H., SM, an associate professor of epidemiology and prevention at Wake Forest University School of Medicine, Lou Haenel IV, D.O., a specialist in endocrinology and diabetes with Roper St. Francis Healthcare in South Carolina, and Robert Kushner, M.D., professor of medicine and medical education at Northwestern University Feinberg School of Medicine, all said they typically advise patients against seeking out compounded GLP-1 RAs.

“It is fair to say that it may not undergo the classic FDA scrutiny,” Haenel said. “It’s certainly not being made by and delivered in a formulation as part of the parent company.”

But some physicians do prescribe the compounded formulas. There are trustworthy compounding pharmacists in the market, and Davis and Nichols offered advice on how physicians can find them. Some of their guidance can help patients as well.

Davis and Nichols agreed physicians should develop relationships with trusted compounding pharmacists, not just for GLP-1 RA drugs. Compounding can expand the availability of treatments for patients.

“If you don’t already have a relationship with a local compounding pharmacy, try to create one. Reach out to them, meet them, get to know them and understand what the scope of their offerings are,” Nichols said.

A short conversation can reveal a lot about an organization, according to Davis.

“Compounding pharmacists are helpful people; they’re problem solvers,” she said. “They’re happy to answer questions about their quality assurance procedures, testing procedures [and] where they source their active pharmaceutical ingredients. And if you’re talking to a pharmacy that’s hesitant to answer any questions like that, I’d find a different partner.”

The same advice holds true for patients, Davis said. Tell them to ask questions and be wary if a pharmacist is not up front with information.

“You don’t have to be a scientist, but ask the pharmacist some simple questions about their quality assurance procedures or their tests that they perform on the final batches of product,” she said. “If a pharmacist is willing to talk to you about those kinds of things, that’s a really good sign. If they’re not, it’s probably not such a good sign.”

), a website that links to each state’s board of pharmacy so users can search for licensure, Davis said.

Physicians or their staff should look for any negative actions regarding a pharmacy license and proceed with caution, Nichols said. It is also fair to ask a pharmacist about their licensing status and the accrediting bodies that oversee them, he said.

Doctors should be aware of the distinction between sterile and nonsterile compounding entities, Nichols said. Nonsterile compounding pharmacies have clean environments to make medicines but typically will not make injectable medications, whereas sterile compounding pharmacies have more stringent guidelines for aseptic preparation settings.

Doctors prescribe medicines, and pharmacists dispense them. It’s up to patients to get the drugs into their body, and they need to know how. GLP-1 RA drugs are injected, so doctors should ask pharmacists what level of counseling and instruction they must provide on preparing and administering injections.

In Nichols’ state of Iowa, “we’re required to counsel with each new prescription and dose change of the medication, so we are providing that education. And yes, usually that entails sitting down with the patient, especially if it’s their first time on a certain medication or a certain administration style,” he said. He noted that different states have different requirements for counseling, but pharmacists should be willing to answer patients’ questions.

Pharmacists and their staff may know about discounts or savings programs that patients and physicians may not be aware of. Many develop expertise in navigating patient insurance plans and prior authorization requirements, Nichols said. Doctors and patients should enlist their aid, he added.

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are gaining popularity for treating type 2 diabetes and obesity, but their high demand and cost have led patients to seek them online, risking exposure to scams and unsafe products. The FDA's drug shortage has allowed compounding pharmacies to produce alternatives, though these are not always the first choice due to potential safety concerns. Physicians are advised to build relationships with trusted compounding pharmacists and educate patients on the risks of obtaining GLP-1 RAs from unverified sources.

With high demand but high prices for antiobesity drugs, patients may fall for phony pharmaceuticals.

Brandon S. Zarsky, Esq.

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