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).
Today marks a big win for Chiropractors, the Florida Chiropractic Association, and other medical providers that treat patients as a result of a motor vehicle accident. Legislation was presented earlier this year which would have completely changed how the personal injury protection (“PIP”) industry would impact medical providers. The legislation is known as Senate Bill 54 (“SB 54”).
SB 54 was sought to end the requirement that Floridians purchase $10,000 in PIP coverage and would instead require mandatory bodily injury (“MBI”) coverage that would pay out up to $25,000 for a crash-related injury or death. This would have meant that for each case before a provider would be paid by the patient’s car insurance coverage, fault would have to be determined through litigation which would have increased the time it would have taken providers to be paid. In today’s landscape providers are able to bill the patient’s PIP coverage for the initial $10,000, and be paid 80% of the billed charges immediately, and if this law would have passed each treating provider would have had to either bill the patient’s health insurance, or treat patients on letters of protection.
In Governor DeSantis’s veto letter he wrote, “While the PIP system has flaws and Florida law regarding bad faith is deficient SB 54 does not adequately address the current issues facing Florida drivers and may have unintended consequences that would negatively impact both the market and consumers.”
Due to the potential repercussions this legislation would have had on an entire industry it is very important for all medical providers today to continue and evolve with the changing landscape. Although providers can take a breather today, because the battle is now over, they must begin to think about how their practices would have been impacted if they could have only billed patient’s health insurance or treated patients on letters of protection. Many providers that I have spoken with were not sure what they would have done, and one piece of advice I always give is that now is the time to start thinking ahead to the future. Meaning, if this law were to present itself again you all have to ask yourself would your practice be able to survive not being paid for months or years? Providers need to start considering how they can better evolve to provide better care to their patients while still being able to survive in the event PIP is repealed in the future.
On March 29, 2021, Florida Governor Ron DeSantis signed the “Civil Liability for Damages Related to COVID-19 Act” into law. The Act was designed to shield businesses from COVID-19 liability claims, and includes a specific section dedicated to protecting healthcare providers. While the protections for healthcare providers are not as robust as those granted to other businesses, the immunity provided by the law (Florida Statutes s768.381) is significant.
The protections apply to virtually all Florida healthcare providers, regardless of whether they are individuals, agencies, or facilities; and cover all “COVID-19 related claims.” The types of claims covered are those arising from:
Medical 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.
Wanna know how often we’re asked whether the laws re healthcare marketing are really enforced? How often we hear “Everyone is doing it.” “Surely they [regulators] understand that every healthcare business has to market its services and item,” we’re told. And when we start to educate people re the state and federal laws that pertain to marketing healthcare items and services (INCLUDING those for which payment isn’t made by a state or federal healthcare program), their impatience and intolerance is palpable.
Take a look at the latest report from the Department of Justice guilty plea from someone who marketed the services of a genetic testing lab. He admitted being guilty of receiving over $300K in kickback money (presumably in the form of marketing fees) and now faces (1) a $250K fine, (2) returning all the money he received, and (3) five years in prison!
Marketing any healthcare service or item is at the tip of the sword in terms of regulatory investigation and enforcement. It’s that simple. And so when your lawyers drag you through laws like the Anti-Kickback Statute, the Florida Patient Brokering Act, the federal health insurance fraud law, the bona fide employee exception, the personal services arrangement and management contract safe harbor and EKRA, thank them! And expect nothing less. If you do ANYTHING at all in the neighborhood of marketing a healthcare item or services, the first place to start is: meet with a very experienced healthcare lawyer who is not learning on your dime. And have them take a couple hours to educate you about the laws, the options and the risks of each one. And once you’ve done that, ask them what more you can do to reduce your risk, for instance—
The issue of scope of practice is front and center in Florida right now with the expansion of what nurse practitioners (and nurse midwives) are legally permitted to do. The newly enacted 464.0123 allows for qualified APRNs (there is specific criteria) to practice independent of a supervising physician in the following areas of medicine–primary care, family medicine, general pediatrics, and general internal medicine.
Even more, assuming they meet the membership criteria for admission to a healthcare facility medical staff, they may admit patients, manage patient care, and discharge patients. One of the only preserved connections with a physician established by the law is if the APRN practices at a healthcare facility, a transfer agreement including a physician is required. Additionally, the new law establishes a Council On Advanced Practice Registered Nurse Autonomous Practice, two members of which are appointed by the Board of Medicine and an additional two appointed by the Board of Osteopathic Medicine.
Has your attorney ever told you to do your best to comply with certain safe harbors to the Federal Anti-Kickback Statute, and you’ll be likely to survive scrutiny under the Florida Patient Brokering Act (the PBA)? If you’ve heard that, it’s time to re-examine that relationship. In the last month, the Patient Brokering Act has been amended, and then interpreted by a court of law in a way that affects all healthcare providers.
The Patient Brokering Act has been used in recent years to prosecute abuses in the addiction treatment industry. Other healthcare providers subject to the act have largely been uninvolved in these prosecutions. However, the PBA has been remolded 4 times in the past 5 years as a means to tailor it to allow for prosecutions of bad actors in healthcare, including addiction treatment. One item should be made clear: the PBA applies to any facility at all that is licensed by the Agency for Healthcare Administration (AHCA) or practitioner licensed by the Department of Health (DOH), including physicians, surgery centers, home health agencies, skilled nursing facilities, hospitals, DME providers, diagnostic imaging facilities, clinical laboratories, pharmacies and many other. During the legislative process, barely any healthcare industry representatives (from any provider group) showed up to any legislative workshops or produced counterbalancing input or language proposals that reflected a broader perspective.
As you may have heard, the State Hemp Plan, SB 1020, has passed the Florida House and Senate and is waiting for Governor DeSantis’ action (approval or veto) or inaction (no veto). The Governor’s approval or failure to veto SB 1020 means SB 1020 will become law. So what does this mean for Florida?
SB 1020 is meant to bring Florida’s laws regarding the cultivation and processing of hemp in line with the Federal Farm Bill of 2018 which removed hemp from the DEA’s list of controlled substances and legalized the industrial use of hemp. Currently, hemp is listed as a controlled substance under Florida law. SB 1020 will change that and allow cultivation of hemp and distribution and retail sale of hemp extract.
Most everyone knows that laws are being implementing in federal and state government to address the opioid crisis in the US. One such law is the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law in October 2018 by President Trump. While the SUPPORT Act seeks to increase access to treatment for substance use disorders and prevention of substance use disorders, it also contains language to prevent abuse of the process to increase treatment access. Specifically, incorporated into the SUPPORT Act is the Eliminating Kickbacks in Recovery Act (“EKRA”) which directly targets unlawful referrals to recovery homes, clinical treatment facilities, and laboratories.
EKRA is similar to prohibited kickbacks and patient brokering pursuant to Sections 456.054 and 817.505, Florida Statutes, using similar language as both Florida statutes. EKRA makes it unlawful…
Imagine running a successful business: inventory is growing and flourishing, staff is happy, operations are smooth, and all of a sudden – a notification arrives that a bank foreclosed on the property the business rents from the landlord, with no advance notice.
In the blink of an eye, the location is gone, the risk of losing of inventory is imminent, and cash flow is impacted during the transition to find another cultivation space. This type of situation can, and has, happened. But what could have been done differently before establishing operations?
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.