The Department of Health and Human Services (HHS) has issued a letter to teaching hospitals and medical schools, emphasizing the necessity of obtaining informed consent from patients before conducting sensitive examinations, particularly when the patient is under anesthesia. The letter comes in response to reports indicating that medical students often perform such examinations without obtaining proper consent during their training. The HHS insists on the importance of documenting informed consent and upholds the patients’ right to refuse such examinations for teaching purposes. The Centers for Medicare & Medicaid Services (CMS) has provided new guidelines to clarify hospital responsibilities regarding informed consent. Furthermore, the Office for Civil Rights (OCR) underscores the HIPAA Privacy Rule, which allows patients to restrict access to their protected health information (PHI), even when unconscious.
Some consumers are being switched from one ACA insurance plan to another without their consent, potentially disrupting their medical care and prescription needs. This unauthorized switching can also lead to large IRS bills for back taxes. Agents can access a policyholder’s coverage using only a person’s name, date of birth, and state. This ease of access plays a significant role in the problem.
Consumers may end up in plans they did not choose and may bear tax burdens if they are signed up for coverage that includes premium tax credits for which they are ineligible.
The Centers for Medicare & Medicaid Services (CMS) is aware of the problem and has outlined technical efforts to resolve issues when complaints are lodged. However, it is unclear whether these efforts will be sufficient. CMS is considering further regulatory and technological solutions, including two-factor authentication. States that run their own marketplaces have been more successful in preventing unauthorized switches as they require more information before a policy can be accessed.
The issue is causing an outcry from agents who lose out on commissions when their clients are switched by other agents. It also casts a shadow on a record year for ACA enrollment, with more than 21 million people signing up for 2024 coverage.
Florida, Georgia, and Texas appear to be hotspots for plan-switching.
Some agents suspect names and lists of potential clients are being circulated to agents willing to bend the rules. Online or social media advertising is a way some outfits troll for prospects, who then end up on lists sold to brokers or are contacted directly by agents.
Semaglutide weight loss drugs are quite literally saving people’s lives. There are so many health benefits to losing weight that demand for the drugs is off the charts. Demand is so high that the manufacturer can’t keep up and the drugs are in short supply.
Where there is money to be made, there will be people willing to step in. Enter compounding pharmacies, who are catering to the demand by creating supposed duplicates of the drug.
But not all semaglutide is created equally, and concerns are rising that some pharmacies are creating inferior versions of the drug that are, at best, less effective or, at worst, dangerous.
How does semaglutide work?
Ozempic was approved by the U.S. Food and Drug Administration (FDA) in 2017 for use in adults with type 2 diabetes. After patients reported significant weight loss, Novo Nordisk rebranded the drug as Wegovy and received FDA approval in 2021 for use in chronic weight management in adults.
Semaglutide, the active ingredient for both drugs, mimics the function of a hormone that is naturally produced in the body. This hormone, released into the blood after you eat, helps lower blood sugar by stimulating insulin production, decreasing the amount of glycogen created in the liver, and ultimately making you feel fuller longer.
In short supply
These drugs work really, really well. So well, in fact, physicians prescribe Ozempic, the diabetes drug, “off-label” for weight loss. The manufacturer cannot make them fast enough due to a shortage of semaglutide. Both Ozempic and Wegovy have been on the FDA shortage list since March 2022.
This creates an attractive opportunity for compounding pharmacies. As long as the drugs stay on the official shortage list, they can be copied by compounders without fear of patent infringement.
And copy them they do. But how well?
Base or salt?
Ozempic and Wegovy use the base form of semaglutide. The base form has been approved by the FDA for the treatment of diabetes and obesity. But some compounding pharmacies are using different forms of semaglutide, known as semaglutide “salts,” that are chemically different from the base version.
Semaglutide salts have not been approved by the FDA, leading some authorities to caution patients about the efficacy or safety of the variant.
The FDA has received adverse reports from some patients after using the compounded semaglutide, which prompted them to send a public letter to the National Association of Boards of Pharmacy expressing agency concerns with the use of the salt forms of the compounded products. Some state pharmacy boards have also voiced concern.
The manufacturer of the brand-named drugs is making waves, too, and in some cases, threatening and filing lawsuits against pharmacies compounding the drugs and the health care providers administering them.
Best practices
Although the manufacturer is trying to step up production, the demand for semaglutide products will likely continue to outstrip the supply for the foreseeable future. Undoubtedly, many patients and their providers will turn to compounded variants to meet demand.
A physician’s responsibility goes beyond just prescribing the drug. They should understand how the drug is compounded and investigate the efficacy and safety of the salt forms of the product. Then decide if the salt form is appropriate for their patients.
If it is, providers should inform their patients. The Texas Medical Board considers the administration of non-FDA-approved drugs to be a form of alternative medicine. Medical board rules require that patients be informed that the drug is not FDA-approved and be told of the risks associated with the drug.
Pharmacies, too, play a key role as the backbone of our medication dispensing infrastructure. They should stay abreast of the regulations governing the compounding of semaglutide and the ethical considerations of preparing a medication for an individual patient.
They should follow the United States Pharmacopeia (USP) standards. Maintain a clean and safe environment, train personnel, appropriately label the medications, accurately identify the active ingredients, and provide accurate use instructions.
Patients have a responsibility, too. Talk to your doctor and discuss the risks and benefits of the compounded drug. If you and your doctor decide the drug is right for you, keep the lines of communication open with your physician and disclose any adverse reactions as soon as possible.
The future
The demand for these weight loss drugs will remain high for the foreseeable future. Until supply catches up with demand, growing pains will be felt in all corners of our healthcare delivery system.
From the companies that manufacture and compound the drugs to the physicians who prescribe them, the patients who take them, to the insurers who will be asked to pay for them – everyone has a responsible role to play.
On October 8, 2023, the California Governor signed Assembly Bill 1286 (AB 1286), a comprehensive pharmacy bill aimed at enhancing patient safety. The bill’s key mandate is a new requirement for community pharmacies to report outpatient medication errors to the California Board of Pharmacy. The legislation also includes several other provisions that regulate the practice of pharmacy in California.
The bill was enacted in response to a 2021 survey by the California Board of Pharmacy, which revealed significant staffing issues contributing to medication errors. The survey found that 91% of retail pharmacists reported inadequate staffing for safe patient care, 83% lacked sufficient time for safe patient consultation, and 78% had insufficient time to conduct proper health screenings before administering immunizations. This led to the establishment of a Medication Error Reduction and Task Force Ad Hoc Committee and the sponsorship of AB 1286.
AB 1286 also introduces several other changes, including amendments which govern staffing decisions in pharmacies and the responsibilities of the Pharmacist-in-Charge (PIC). The law now requires chain community pharmacies to be staffed at all times with at least one clerk or pharmacy technician dedicated to pharmacy-related services, subject to certain conditions. The bill also expands the list of actions that constitute unprofessional conduct and authorizes specially trained pharmacy technicians to prepare and administer certain vaccines and medications.
On March 20, 2024, the USPTO issued an alert about new training materials for patent examiners, developed to enhance searches for prior art in FDA and NIH databases. The training was first presented at the Biotechnology, Chemical, and Pharmaceutical Partnership Meeting on March 19, 2024.
The materials guide patent examiners on using various FDA and NIH resources to search for drug information. These resources include FDALabel, Drugs@FDA, and DailyMed. Examiners were also given guidance on how to use Google for searching FDA.gov.
These materials were developed as part of the ongoing collaboration between the USPTO and the FDA, initiated by Executive Order 14036, which seeks to promote competition in the American economy. The goal is to balance the patent system to incentivize investments for life-saving drugs and biologics, while preventing its misuse to delay the introduction of affordable generic drugs and biosimilars.
The impact of these training materials on patent examination for brand-name drugs and biologics is yet to be seen. Further examiner training is expected under these ongoing collaboration initiatives.
Physicians are raising concerns over the lack of regulation and policy enforcement in the medical spa (med spa) industry, following the death of Fairfield resident Jenifer Cleveland after an IV treatment at a med spa. Dr. Patricia Aronin, affiliated with the TX400, a group of Texas physicians, has called for changes in the industry, which she describes as largely unsupervised and prone to malpractice.
Med spas, offering services ranging from IV therapy to skincare and cosmetic procedures, have grown in popularity but lack sufficient oversight. According to Dr. Aronin, many people do not realize that these services are medical treatments requiring adequate supervision and record-keeping. She asserts that the current state of affairs has been deteriorating over the past decade and has called for changes before more incidents occur.
The issue is compounded by the structure of the medical industry and Texas law, which has created opportunities for illegal practices within med spas. Dr. Aronin highlights that the Texas Medical Board requires good faith examinations and proper medical record-keeping, both of which she suspects are lacking in many med spas.
In response to Cleveland’s death, the Texas Medical Board temporarily suspended the license of Dr. Michael Patrick Gallagher, who served as the medical director at the med spa where Cleveland received her treatment. Dr. Aronin emphasizes that the role of the medical director in med spas is a critical area requiring reform, including clearer guidelines on hiring practices and the responsibilities of the position.
Dr. Aronin also calls for patients to be more proactive in advocating for their health, urging them to inquire about qualifications, practices, and equipment at med spas. She stresses the need for the public to recognize that med spa treatments are serious medical procedures, not casual beauty treatments. As of 2022, 63% of med spas were owned by non-physicians and non-surgeons, according to the American Med Spa Association.
I’m going to let you in on a little secret. Most med spas in Texas are not compliant with Texas law.
Either they are formed as the wrong legal entity type, they lack proper ownership or oversight, they are not following the standard of care, or all of the above.
The consequences can be significant for everyone involved.
For med spa owners, the Texas Medical Board can shut down your business. In extreme cases, you could be charged with practicing medicine without a license. If a patient gets injured, you could face civil liability. If your MedSpa is not formed or owned in compliance with Texas law, the insurance company could deny coverage, leaving you you holding the bag.
Physicians associated with non-compliant med spas can be disciplined by the Texas Medical Board. Those physicians are literally putting their medical licenses at risk.
Med Spas Provide Medical Services
I’m using the term med spa to describe several types of businesses—traditional med spas, IV hydration or IV therapy businesses, medical weight loss clinics, those types of retail medical services.
It should come as no surprise that the “med” in med spa stands for medical. We call them med spas because many of the services they provide are considered medical services. Botox injections, microneedling, dermaplaning and dermablading, cool sculpting, medium and deep chemical peels, are all considered non-surgical medical cosmetic procedures by the Texas Medical Board.
IV hydration and therapy, medical weight loss injections, and hormone therapy are also considered medical services. If a procedure involves injecting a patient or removing living tissue, it is probably a medical procedure.
Med Spas Must Be Formed Correctly
Because med spas provide medical services to the public, they must comply with Texas law just like any other medical practice, and that means they must be formed as an appropriate legal entity.
In Texas, medical practices can only be formed as professional associations, professional limited liability companies or PLLCs, or partnerships with other licensed physicians.
Many med spas in Texas today are incorrectly formed as corporations or regular LLCs. This is not allowed. Corporations and LLCs cannot be medical entities. The other requirement is proper ownership.
Med Spas Must Be Owned by Physicians
Medical entities, like med spas, cannot be owned by non-physicians. They must be owned by persons licensed to practice medicine in Texas.
Let me say that again.
Med spas cannot be owned by non-physicians. They must be owned by persons licensed to practice medicine.
A physician is a person licensed by the Texas Medical Board as a medical doctor, an MD, or a doctor of osteopathy, a DO.
But all is not lost. There is a way to structure a med spa correctly, even if you are not a physician.
Management Model
Through the magic of the management model, non-physicians can run a med spa and share in the profits.
Here’s how it works.
We still create a medical practice, like a PLLC, that will be owned by a physician, but we also create a management company owned by you that will run and manage the medical practice. You will be responsible for running the practice, but you do it through your your management company.
When patients pay for MedSpa services, that money is deposited into the Medical Practices Bank account. You, as the manager, have access to the Practices Bank account and you will pay all the business expenses from that account—rent, supplies, payroll, utilities, insurance, for example. What’s left over is paid to your management company as a management fee for your work in running and managing the practice.
So, in the management model, a physician still owns the medical practice, but you own the management company that runs the medical practice, and you take the profits as a management fee.
Special Arrangements
Let me pause here and say that if you happen to be a physician, things are more streamlined. We don’t have to use a separate management company. Physicians, of course, can own the medical practice.
If you are a podiatrist, chiropractor, or optometrist, there still must be a physician owner, but we don’t have to use a separate management company. You can jointly co-own the medical practice with the physician.
If you are a physician assistant, Texas does allow you to co-own the medical practice with a physician. However, you can only be a minority owner and the physician must be the majority owner.
Nurse practitioners unfortunately do not have the same opportunity as physicians. physician assistants. Nurse practitioners cannot co-own any part of a medical practice with a physician. The same is true for registered nurses.
So, if you’re a business person, a nurse practitioner, or a registered nurse, you must use the management model to operate a med spa.
Good Faith Exams
We have talked about the correct legal entity type and the correct ownership. Now let’s talk about an operational issue, the good faith exam.
A good faith exam is a medical examination conducted by a physician or a mid-level provider, like a physician assistant or a nurse practitioner, to assess a patient’s current condition and develop a plan of treatment. If you’ve ever been to a doctor, you have received a good faith exam.
Some med spas hire mid-levels on a part-time or as-needed basis to come into the med spa to perform these good faith exams. Other med spas use telehealth exams. Patients will schedule a telehealth exam prior to a med spa visit. The mid-level will perform a good faith exam and rule out contraindications and then write an order for a med spa treatment like IV infusion or a Botox injection.
Common Questions
That covers some of the requirements for Texas med spas. Now let me answer some common questions I get from clients.
Question 1. No one else I know is doing it this way. Are you sure this is right?
Yes, I’m sure. It’s unfortunate that many med spas are not formed or operating correctly. If you have researched med spas, you know how difficult it can be to get straight answers.
The problem is there is a lot of misinformation on the internet. Much of it is incomplete or just plain wrong. Some of it might be right for other reasons. states, but not in Texas.
It’s important to understand that each state has its own laws that apply to med spas. It’s no wonder there is so much confusion. The information I’m giving you is correct for Texas, but it won’t apply to other states.
Question 2. I don’t want the physician to have access to the business. How can I protect my business?
Well, I don’t blame you, and because of that, we build in certain protections into the documents.
We specify that the physician cannot sell or transfer their interest to any other person without your permission.
We give you access and control to the bank accounts for the medical practice. In that way, you control the money. We create a process to change physicians if that ever becomes necessary. If the physician some day decides they want to move on, we don’t have to create a brand-new medical practice.
We just transfer ownership of the existing medical practice to a substitute physician.
Finally, the management company that you own will own your med spa’s brand and name. The management company will license that name to the medical practice. The medical practice can’t use it without your permission. In that way, you always maintain control of your brand.
Question 3. How does the physician get paid?
The physician gets paid a flat fee every month for supervising the mid-level provider.
In Texas, mid-level providers must be supervised by a physician. The Texas Medical Board has established rules for this supervision. Physicians who don’t properly supervise the mid-level provider can be disciplined by the medical board.
The physician usually doesn’t see the patient. They supervise the mid-level provider who does see patients and for that they get paid a monthly flat fee somewhere in the range of $1,000 to $3,000 per month.
Question 4. What kind of insurance do I need?
You need a general liability policy for slip and falls and you need a professional liability policy for hypothetical malpractice claims.
Physicians and mid-level providers probably already have a malpractice policy. Sometimes you can add the MedSpaw as an additional insured to those policies.
My preference is that you get the med spa its own malpractice policy that covers every practitioner who works works for the med spa. That way, you don’t have to depend on others to have the right amount of insurance for your business.
Question 5. Are there any legal risks for the physician?
There is always some level of risk. A patient who has a bad experience can file a complaint with the Texas Nursing Board or the Texas Medical Board. If that happens, the provider will have to justify the services they provided to that patient.
For the physician, it’s important that they take seriously their responsibilities to supervise the mid-level provider. There must be a supervising agreement between the physician and the mid-level. The physician needs to review a sample of patient charts every 30 days and address any concerns with the mid-level, and the physician needs to be available to answer the mid-level’s questions as they come up.
For the mid-level provider, it’s important that they are thorough when performing the good faith exams and that they keep good medical records. What are the next steps?
Conclusion
I’ve covered a a lot of information. I would encourage you to watch this video more than once. You will probably key in on new information each time.
Well, that’s it. Best of luck to you. You’re on an exciting journey. I look forward to the opportunity to help you along the way.
The proposed rules, according to the TMB, are designed within the limits of existing laws to clarify the criteria the Board will consider if it receives a related complaint. The Board emphasizes that it does not have the authority to change or create new definitions in existing laws, nor does it have the power to regulate or prohibit abortion.
The Board is cautious about specifying particular conditions or scenarios that would qualify as exceptions. It recognizes the individuality of each patient and the complexity of medical practice, asserting that it is impractical and impossible to create a comprehensive list of situations that may arise in any given patient scenario.
The Board stresses the importance of “reasonable medical judgment,” which depends entirely on the patient’s unique circumstances and the expertise of the treating physician. Even if there were a list of conditions, it would not be enforceable without going through the standard process, given the varying impact of the same condition on different patients.
From The National Law Review, Jean Marie R. Pechette, Neal D. Shah, Joelle M. Wilson, Catherine Kozlowski, Matthew T. Lin:
Artificial Intelligence (AI) is significantly influencing the field of behavioral health, offering potential advancements in diagnostics, treatment, and patient outcomes. The application of AI technologies ranges from virtual mental health assistants and predictive analytics to AI-enabled chatbots for therapy and AI-integrated Electronic Health Records (EHR) for diagnosis and treatment. These technologies are expected to expand further as trust in AI systems grows.
Despite the transformative potential of AI in behavioral health, the legal and regulatory implications are uncertain. The US lacks a comprehensive federal law that regulates AI development and use. However, efforts are underway to address potential risks, including promoting transparency, ensuring fairness, and protecting privacy and security of health information.
Key legal risks associated with the use of AI in behavioral health treatment include data privacy, algorithm bias, and professional liability. Data privacy risks involve ensuring compliance with HIPAA, 42 CFR Part 2, and state privacy laws.
Providers can mitigate these risks to some extent by obtaining informed consent from patients before using AI tools, vetting third-party vendors offering AI solutions for adherence to data privacy and security rules, seeking transparency from developers and vendors about the data on which AI tools were trained, and reviewing the scope of professional liability coverage before adopting AI-enabled tools.
While AI holds significant promise for transforming behavioral health care, it’s crucial to anticipate and address the evolving regulatory frameworks and legal risks associated with AI applications. AI regulation is a moving target, and anticipating and mitigating legal risks will be key to fostering a trustworthy and secure environment for both practitioners and patients.
A devestating cyberattack on payment processor Change Healthcare has spurred discussions in Washington about urgent cybersecurity regulations for the healthcare sector. Health and Human Services (HHS) is working on developing mandatory rules, including updating the Health Insurance Portability and Accountability Act with cybersecurity requirements.
These updates are meeting resistance from the healthcare industry, which argues that hospitals should not be punished for the success of hackers. President Biden’s budget proposal includes funding for hospitals’ cybersecurity efforts and penalties for non-compliance. Despite this, the complexity of implementing such standards, especially for smaller health entities, and the current political climate suggest no significant changes will occur soon.
