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
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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
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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?
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Understanding the Regulations
- 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.
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Corporate Structure
- 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.
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Licensure
- 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.
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Operations Planning
- 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.
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Trademarks and Branding
- 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.
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Corporate Compliance
- Once you’ve built the foundations of your new practice, protecting its assets should be high on your priority list.
- 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.
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How Autonomous Practice Is The Biggest Business Opportunity for 2021
By: Chase Howard
With the passage of autonomous practice ability for nurse practitioners in Florida this year, many are wondering how this will affect the healthcare industry in Florida. In a traditional sense, rural and underserved areas should have the opportunity for growth in healthcare providers. The autonomous practice law removes restrictions on certain nurse practitioners, granting them the ability to practice in primary care practice settings without worrying about supervision restrictions. Outside of that, the application of the new law can expand healthcare business offerings and abilities. Continue reading
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Recap: Dental Employment Contracts
By: Chase Howard
Many young dental professionals are presented with the opportunity to join a practice after graduation. Making an informed decision and negotiating a fair contract can be difficult but will ultimately pay dividends for years to come. Here are some items to consider when reviewing and negotiating your employment contract.Continue reading
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Forward Looking: How to Prepare for 2021
We’ve all learned a lot in 2020, but are we prepared for what 2021 will bring? The change of the calendar won’t make the pandemic go away, but you can prepare your medical practice.
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First Steps for APRN’s When Opening an Autonomous Primary Care Practice
Florida Advanced Practice Registered Nurses can now own and operate autonomously in primary care without a supervising physician. Learn more on how to get started.
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APRN Requirements for Autonomous Practice
Although APRN’s can practice autonomously without physician supervision, there are requirements that they must meet before moving forward.
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Dentist Employment Contracts
By: Chase Howard
A dentist’s first employer agreement is just as important as their last one. While all contracts include basic terms regarding compensation and restrictions, many simply do not contemplate important terms that have impacts on Dentist’s daily lives. Understanding, and negotiating, your contracts is the most valuable investment you can make prior to entering into a contract.
To understand what’s in your employment contract, simply read it over a few times. To understand not only how those terms affect you, but also what isn’t in your contract, hire an experienced health care lawyer.Continue reading
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You Don’t Know What You Don’t Know – Acupuncturist Employment Contracts
By: Chase Howard
Thinking about joining an integrated or group practice? The average employment contract exceeds twenty pages, not including exhibits. While some parts might seem simple and non-legalistic, many simply do not contemplate important terms that have serious impacts on Acupuncturists daily lives. An employment contract is the most significant financial decision of an Acupuncturists lifetime. The same can be said for each subsequent contract, which means that understanding, and negotiating, your contract is the most valuable investment you can make prior to entering into a contract.
To understand what’s in your employment contract, simply read it over a few times. To understand not only how those terms affect you, but also what isn’t in your contract, hire an experienced health care lawyer. While it’s important to understand what is in your employment contract, it’s equally as important to know what is missing from the contract and what to ask in regards to what is included. The below list considers terms that are important both during and after employment.
The following are nine items you should consider including in or asking about your contract:
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Lease Considerations – Acupuncture Practices
By: Chase Howard
Reviewing a lease prior signing will save you extreme headache and cost in the long run. Landlords tend to act as if they have all of the power in negotiations and will make their own rules along the way. Lease negotiations are complex and involve significant business and legal considerations.
Here are guidelines to ensuring that your lease is reasonable and fair:
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Corporate Start-Up for Acupuncturists
By: Chase Howard
As an Acupuncturist in a private, solo-practice or group practice, proper start-up is key. Understanding how to set up your business properly with the State and IRS, developing a business plan, and understanding all requirements will help eliminate obstacles that will slow your growth.
When working with new acupuncture businesses, consider the following:
a. 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 professionals choose a limited liability company, corporation or a professional association. 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.
2. Obtaining an EIN/TID
a. Before you can open a business bank account, or even do business in your city, you will need to obtain an Employer Identification Number or Tax ID for your business. Properly applying will save you time down the road with IRS tax issues.
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Florida and Federal Trademarking Differences
By: Chase Howard
In a recent article, I touched on some of the reasons to consider trademark registration and what is required. Many people hear trademarks and might think only of the Federal registration through the United States Patent and Trademark Office (USPTO). Florida, however, also offers state level registration for marks that likely won’t qualify at the Federal level.
Trademark registration grants an intellectual property rights that help its owner protect a brand’s mark, logo, name or any other way that it conveys intangible property.
Trademark protection is available under both Federal and State law. Federal trademark protection allows the brand owner to protect their trademark in interstate commerce, while Florida registration allows trademark protection for marks only in the state of Florida. Florida law does share a lot of the same concepts and requirements of the Federal trademark requirements, however is limited only to protection in the State of Florida. Florida trademarks are less expensive and easier to obtain than Federal trademarks, but are superseded by a Federal trademark registration.Continue reading
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By: Chase Howard
Investing in a healthcare related business involves significant time and money. Building a brand takes even more and is extremely important in today’s society. Having the ability to build a recognizable brand, scale, and potentially sell, is the goal of many healthcare business entrepreneurs. With the ever-booming impact of social media, online advertising, and online reviews, healthcare businesses seek to engage at a higher degree than ever before to attract new patients, retain current patients, and establish themselves as experts in their respective fields.
Building a brand is part of it, while protecting that brand is far more important. A well-recognized word or logo can be worth everything to your business. Obtaining ownership and protection over a name or mark is a fairly simply task with significant rewards. Trademarks are the names, slogans, tag lines, and/or logos that identify and represent your business, its services, and mission to the public, and are the foundation for the business’s overall branding and marketing. Trademarks can also be used to protect your business in a specific area or a specific area of expertise. If you do not protect your brand, a competitor could use it (or something similar, which could confuse the public and your patients and therefore potentially draw business away from your brand.Continue reading
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Florida APRN Independent Practice Update
By: Chase Howard
In March, the Florida Legislature passed multiple bills that would allow advanced practice registered nurses (APRN) to practice independently of physicians in the delivery of primary care practice. The law, however, went into full effect on July 1. Still, the law did not automatically grant autonomous practice to all nurse practitioners. Rather, an application process is still needed, as well as final regulations governing the new law.
In June, the Florida Board of Nursing voted to move forward with the drafting of rules and the application process to be designated as an independent practice Nurse Practitioner. This process usually takes three months to complete before it is open for practitioners to apply. The Board also voted to define “primary care practice” to include “health promotion, disease prevention, health maintenance, counseling, patient education, and diagnosis and treatment of acute and chronic illnesses in a variety of healthcare settings.”
Until final rules are decided, a nurse practitioner will at least need to meet the following requirements:Continue reading
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Prepping Your Dental Practice for Sale
By: Chase Howard
Thinking About Selling Your Practice? Preparation is key and the difference between a successful sale and seller’s regret.
Step 1: Call Your Financial Planner
- Be sure that you can afford to leave the business
- Most buyers will require a comprehensive non-compete and you should be certain that you are financially prepared to retire, sell, or move before signing any restrictions.
- You will also want to ensure that you are planning for the income you are about to receive. Are there vehicles in place or options that are best to ensure the purchase price is put to its best use for you.
- Consider post sale options if not retirement – are you going to be employed by the buyer? Are you selling to an associate and will phase out? Are you just moving and will need to find new employment/open a practice?
Step 2: Visit Your Accountant
- Your business is only worth as much as can be defined on paper.
- If a potential buyer cannot make sense of your accounts and assets, you may leave significant value on the table.
- Get your financial history in order by reviewing tax returns, profit statements, AR reports, and payroll history for prior 3-4 years.
- Clean up creative bookkeeping – you will have to promise the buyer that your financial statements are true and accurate.
- Have your accountant help value assets of your business – or use an appraiser if necessary.
- Discuss company structure – there may be restructuring needs or you may need to transition to a different structure for tax purposes.
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