What’s New with Regenerative Medicine?

The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.

In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.Continue reading

What to Know When Buying a Dental Practice

Preparing to buy a dental practice may seem like a daunting task. There are many considerations, many of which usually require an expert opinion and guidance. Buying a dental practice involves legal, financing, real estate, and accounting expertise, at the very least, to ensure a smooth deal with the buyer being protected. Here’s what to consider:

Legal

Buying a practice usually means buying the assets of the practice, rather than the corporation itself. In any event, the buyer is taking a significant financial and legal risk and just like any other purchase, you want to make sure that you are getting what you paid for and not any (or at least as little as possible) of the baggage. Every dental transaction should include a well-drafted and thorough purchase agreement which includes substantial representations and warranties by the seller, thorough lists of included and excluded assets, terms addressing restrictive covenants, and disclosures about any potential liabilities affecting the practice. In addition, some transactions might require a portion of the purchase price to be seller financed. In that case, there will be a need for a promissory note and security agreement. As the deal progresses, there might be a need for additional documents to cover an assignment of rights for certain licenses, contracts, and other. Among other things, the final document signed includes a bill a sale, which is like a receipt for the buyer evidencing the sale of the assets.Continue reading

Starting a Hormone Replacement Therapy Business

Hormone replacement therapy (HRT) and other similar “body hacking” treatments have expanded significantly over the years. With more and more people choosing alternative treatments to common ailments, these practices have experienced explosive growth in response to the demand. But what does it take to open one of these businesses and how risky can it be?

  1. Understanding the Regulations

    1.  Healthcare businesses, especially in Florida, are heavily regulated. Even as a typically cash-only business, owners must stay aware of the ever-changing regulations. First, Florida and Federal anti-kickback laws affect cash-only businesses in regard to patient referrals. They also apply to laboratory referrals. Florida law has additional regulations against physician ownership in certain entities. In this case, ownership in an HRT business and a lab or pharmacy that you refer to could put you in violation of a number of Florida and Federal laws. While many HRT businesses offer other treatments that are not just hormones, the big draw is hormones, which are considered controlled substances. Prescribing controlled substances requires certain patient evaluation standards, prescribing standards, and pharmacy standards.

  2. Corporate Structure

    1. A company is considered a legal entity and recognized by both the IRS and the State. Depending on the number of owners and type of business, different options exist regarding entity type. Specifically, most healthcare businesses choose a limited liability company, corporation or a professional association, depending on the type of owner. Once you choose the appropriate type of entity, you’ll want to meet with your CPA to discuss taxation of the entity and how that affects the owners personally. Equally as important as choosing the right entity is ensuring that all corporate documents are appropriately buttoned up and protecting the owners.

  3. Licensure

    1. As a business owner, you’ll need additional business, state, county, and city government licensure to do business. Florida has many counties, each with different rules. You may need local tax licenses depending upon your offerings and services as well. In addition to business licenses, you will need to either maintain a Florida medical license or contract a physician to treat patients.

  4. Operations Planning

    1. Starting a successful practice begins months before with business planning. Develop a business plan for financing purposes, gather information regarding day-to-day operations, explore different financing options, develop a practice culture, assess bringing on any partners, and other practice considerations. You will also want to ensure that all of your patient and staffing policies are well thought out and comprehensive.

  5. Trademarks and Branding

    1. People recognize businesses by their logos, name, service, or specialists. Protecting your brand is just as important as building your business. Utilizing Federal or State trademark protections is just one method of building and creating your brand. This is at least a six (6) month process, so the earlier you evaluate your intellectual property, the better.

  6. Corporate Compliance

    1. Once you’ve built the foundations of your new practice, protecting its assets should be high on your priority list.
    2. In a high-earning business, you want to take all the necessary steps to ensure your business looks like and functions as an entity separate from yourself individually. With partners, the right agreements and actions will ensure that the company is treated as a legitimate entity.

While these are some of the biggest considerations, there are many more to opening and operating a successful HRT business.

 

 

 

 

 

 

Medical Spa Industry Is Booming But is Regulation Keeping Up?

medical spa law

medical spa lawMedical Spas nationwide, but specifically in Florida, have been opening up at a staggering pace. For many reasons, including new services, technological advances, and lax regulations, the opportunities for medical spa businesses are endless.

In 2010, there were about 1,600 medspas operating in the United States generating about $1.1 billion in revenue (about $700,000 per medspa on average). By 2018, these numbers increased to over 5,000 medspas generating about $7 billion-$8 billion in revenue (about $1.4 million per medspa on average). The number is expected to grow to over 10,000 medspas by 2023 with about $18 billion-$20.7 billion in revenue.

While medical spa owners have taken advantage of these opportunities, state authorities have yet to keep up. The medical spa industry is largely unregulated, whether that be due to the nature of the services provided, or the explosive growth in this alternative type of medical clinic. On top of that, there’s been a expansion in scope of practice and supervision requirements for certain providers, including nurse practitioners.Continue reading

Buying a Dental Practice? Here’s What to Consider

tips for buying a dental practice

tips for buying a dental practiceBy: Chase Howard

Whether you’ve been in practice for years or you’re just graduating, buying an existing dental practice can be a great way to quickly enter into an already established patient base without the pains of starting up from scratch. While it may seem like a daunting task, the right team can make the purchase transaction flow as smoothly as possible. Here’s a list of important things to consider when negotiating the purchase.

Continue reading

Can I Provide in-home or mobile IV Therapy?

iv therapy

By: Chase Howard

IV hydration therapy has many applications and purposes. In the most common cases, the purpose is for post-surgery recovery or wellness optimization. IV therapy businesses that want to offer a more concierge type of service by offering mobile or in-home services, need to be aware of Florida home health agency laws and regulations.

Continue reading

PLLC v. LLC: What’s The Difference?

healthcare business llc

healthcare business llcBy: Chase Howard

In most cases, the limited liability company, or LLC, is the preferred business structure for a wide variety of healthcare businesses. If you’re a licensed professional, you can also use the professional limited liability company, or PLLC for your healthcare practice or business. While generally these two entity types are the same, there’s a small difference to be aware of when organizing the company.

Continue reading

Aesthetic Clinics and Regulation – What’s Happening?

supervision requirements for medspa

supervision requirements for medspaBy: Chase Howard

Over the last few months, there has been a significant uptick in investigations in the “medical spa” space. The biggest points of enforcement have been in regards to supervision and scope of practice.

The various governing bodies have taken a more active role in ensuring that providers are providing services within their scope of practice as wells as enforcing the various supervision statutes.Continue reading

Autonomous Nurse Practitioners in Private Practices

By: Chase Howard

The new autonomous practice regulations allow certain Nurse Practitioners to practice independent of physicians, without supervision, in certain settings. While we’re awaiting further declarations and definitions from the Board of Nursing as to what is including in primary care, there is already an opportunity for autonomous practice nurse practitioners to establish concierge and direct primary care offices.

The concierge practice model and the direct primary care model, however, are still regulated depending on the way patients pay.Continue reading

Supervision of Electrologists

By: Chase Howard

Changes are coming to the way Electrologists in Florida may be supervised when performing laser hair removal. For years, direct, on-site supervision by a physician was required in order to allow an electrologist to perform laser hair removal. Recently, the Board of Medicine and Electrolysis Council agreed to a rule change, altering the method of supervision to include telehealth.Continue reading