Can Paramedics Administer IVs at Doctor’s Offices, Clinics, or MedSpas?

There has been a lot of confusion lately as to whether Paramedics can administer IVs at doctors’ offices, clinics or MedSpas. While these professionals are trained to administer IVs during emergency transport, they are not allowed to administer IVs in most other situations.

The statutes and rules pertaining to paramedics and scope of practice fall under Chapter 401, Medical Telecommunications and Transportation, Florida Statutes, and Chapter 64J-1, Emergency Medical Services, Florida Administrative Code.

Based on definitions and the text of the statutes and rules, although a paramedic is trained to administer IVs, they can only do so during the course of emergency services and transportation and at public health care programs. Further, a paramedic’s services must be rendered under a medical director’s supervision, as the term medical director is defined under Section 401.23, Florida Statues. Under this statute, a medical director “is a physician employed or contracted by a “licensee” and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training pursuant to this part.” Section 401.23(15). Pursuant to statutes, a “licensee” means any basic life support service, advanced life support service, or air ambulance service licensed pursuant to this part.” Section 401.023(13).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.

 

 

 

 

 

 

Noncompetes, Healthcare and a New Executive Order

On July 9, 2021, President Biden signed a far-reaching Executive Order that could have significant impact on the healthcare industry.  Under the Executive Order, President Biden:

– Encourages the Federal Trade Commission to ban or limit noncompete agreements, and to ban unnecessary occupational licensing restrictions;

– Supports the practice of state and tribal programs importing drugs from Canada;

– Directs HHS to increase support for generic and biosimilar drugs, and to issue a comprehensive plan to, “combat high prescription drug prices and price gouging” within 45 days;Continue reading