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.
Stem cell law has been heavily contested in the courts for decades in the United States, and the hotly debated topic has strong support on both sides.
In fact, it is not just at the federal level that lawmakers have been unable to reach a decision. Each state has also fought through the different permutations of stem cell research law in its own courts, and decisions are continually being overturned.
What Is Current Federal Law on Stem Cell Research?
At the federal level, there is no explicit regulation regarding stem cell research. This puts the decision into the hands of each state, according to the will of the locality.
However, federal funding for scientific research does have an impact on the developments in stem cell research and where the stem cells are resourced.
Different presidents have either put a hold on stem cell research or lifted the holds placed by their predecessor. Depending on the current state of the union, stem cell research has a greater or lesser chance of approval for federal funding.
Where Does Florida Law Stand on Stem Cell Research?
SB 954 in Florida has been batted back and forth in the state’s congress, as lawmakers seek to come to an agreement on what it means to engage in ethical research for the advancement of medical treatment.
Making sure that the Department of Health is held to a specific date by which they must adopt the new rules in the bill.
Ensuring that any patients who are to receive an “investigational” stem cell treatment will sign a consent form in advance to ensure they understand what is happening and what they are agreeing to.
Dictating that only licensed, certified, and active physicians may administer an “investigational” stem cell treatment to any patient for any purpose.
Requiring that all stem cell treatments be overseen by a review board put in place for that purpose.
All the specifics of the bill seem to prioritize making sure that all patients have full knowledge of what a stem cell treatment is in advance, that the treatment is administered by someone who is knowledgeable and well-trained, and that the treatment is further overseen by a governing board that will be quick to respond to any abuses of the process.
Where Can I Get More Information About Stem Cell Research Law?
If your medical business is involved in stem cell research and you would like to ensure that you are fully compliant with current law, or you want to know how pending stem cell law may impact your work, contact Florida Healthcare Law Firm today to schedule a consultation. We can assist you in remaining compliant as the law in Florida changes.
Gaining licensure to become a chiropractor is no small feat. Many new chiropractors are ready to jump into starting their own chiropractic clinic, while others prefer to work for other companies before they branch out on their own.
The choice you make should be based on your circumstances, personality, and long-term goals. It should also center on what is legally allowed in the state of Florida.
Licensed Chiropractors May Start Their Own Clinic
For chiropractors ready to start their own business, there is no Florida law standing in the way. In fact, as a fully licensed and active chiropractor, you are one of the few people in the state of Florida who can legally hire other chiropractors.
In fact, a Florida statuteexplicitly states that, with few exceptions, a chiropractor may not work as an employee or an independent contractor for any corporation, person, or limited liability company that is not owned by an active and licensed chiropractor.
Exceptions include businesses owned by physicians, hospitals, a clinic affiliated with a chiropractic school, a publicly traded corporation, a nonprofit, an insurance company, a HMO clinic, or a healthcare clinic that also employs other doctors.
This list of exceptions may seem to cover all scenarios, but it does limit the abilities of small businesses owned by non-physicians from hiring chiropractors. The purpose is to ensure the ability of the chiropractor to engage in their scope of practice without undue influence from a company owner that may not be familiar with the law or chiropractic care.
Avoid Chiropractor Lawsuits
The best way to avoid chiropractor lawsuits based on an employer’s status will vary by state. Many Florida chiropractors don’t realize that there are laws limiting whom they can work for.
There are a number of laws in place to ensure that patients are protected and never sent out for unnecessary referrals that may be more financially than medically motivated.
For this reason, Florida has instituted the Florida Patient Brokering Act, otherwise known as anti-kickback statutes, that may impact local healthcare clinics and medical offices.
What Is the Patient Brokering Act?
The Patient Brokering Act in Floridamakes it illegal for any organization to provide bonuses, split-fee arrangements, benefits, commissions, or any kickbacks for patient referrals.
This means that a specialist may not pay a commission or kickback to a general practitioner for referring a patient to their care, nor can any healthcare office offer a bonus or rebate to any patient for choosing their services.
How Did the Florida Patient Brokering Act Change Healthcare Practices?
Previously, it was normal practice for one healthcare facility to recommend a certain provider or treatment center to patients who sought care outside of the originating facility’s purview. In return, the referred party might pay a commission on the services rendered to that patient or otherwise offer a bonus or kickback of some kind for that referral.
Unfortunately, that practice resulted in a number of referrals being made for patients who may not be in medical need of that care. With the goal of generating a kickback, a referring facility might send a patient to the partner provider even if it was not for a necessary treatment. This meant that the referred facility would charge the patient’s insurance for care that may or may not be medically necessary, creating an abuse of insurance and, in some cases, putting the patient at risk as well.
What Do the Florida Patient Brokering Laws Mean for Florida Healthcare Providers?
For healthcare facilities or providers that have been charged with patient brokering, action is needed. Contacting a healthcare attorney is essential to making sure that you are fully equipped to protect your reputation and get back to focusing on what you do best.
No healthcare professionals are immune to the Florida Patient Brokering Act. Doctors, dentists, and pharmacists may all be accused of taking kickbacks for patient referrals.
Similarly, hospitals, dental offices, drug addiction treatment programs, nursing homes, and pharmacies can be brought up on the statute as well.
Are There Any Exceptions to the Anti-Kickback Statutes in Florida?
Yes, there are a few. Perhaps the most important of these is that providers within the same group practice can avoid repercussions for referrals with any financial benefit if they are for providers within the same group.
Similarly, some contracted health benefit plans can circumvent the problem as well.
During COVID, telemedicine (the ability to get healthcare online via video call or by telephone) was a lifesaver. Especially before the vaccine was available, everyone was at risk when entering a medical treatment facility. The medical community responded by making sure that telemedicine options were available.
In most states, laws were passed to ensure that patients were covered for telehealth visitsjust like any other form of healthcare. In Florida, the legal measures taken for that purpose have expired. Healthcare providers are left wondering how to best serve their at-risk patients.
What Is Parity Law?
In general, parity law seeks to ensure that all patients are provided insurance coverage equally, no matter what the nature of their ailment. In most cases, it speaks to the treatment of mental health and addiction issues, ensuring patients get coverage for treatment of these disorders as easily as they can for any medical disorder.
What Is the Mental Health Parity Law?
Mental health parity laws make sure that patients who need treatment for mental health issues, including addiction, can get insurance coverage for their care, just as they would if they were to seek treatment for diabetes or cancer.
What Is Telehealth Parity Law?
Telehealth parity laws make sure that insurance coverage is provided for medical appointments that occur over the phone or via a video conferencing call, just as it would if the appointments were in person.
During COVID, telehealth parity laws have been a huge focus in the Florida healthcare world since the governor signed a waiver to ensure that patients would be able to access telemedicine with ease.
Healthcare businesses are often confused by Florida law regarding durable medical equipment, but the truth is that legal compliance and licensure is a simple process that can save home medical providers tens of thousands of dollars every year.
What Is Durable Medical Equipment?
Durable medical equipmentis defined by Medicare as a piece of machinery that is used repeatedly for a medical purpose with an expected lifetime of at least three years.
Here are a few examples of durable medical equipment:
Hospital beds and air-fluidized beds
Wheelchairs, electric mobility machines, and lifts
Blood sugar monitors and test strips
CPAP devices and CPM machines
Crutches, walkers, and canes
These are just a few of the types of equipment that fall under the “durable medical equipment” definition in the state of Florida. If you believe that any equipment that your business provides to patients falls under the more general definition, reach out to Florida Healthcare Firm to find out what you need to do to protect your business from regulation violations.
What Florida Laws Pertain to Durable Medical Equipment?
One of the first Florida laws related to durable medical equipmentis that the healthcare business that rents or provides this equipment to patients must be licensed to do so by the state. One license is needed for each location. In Florida, many doctors and chiropractors that provide durable medical equipment to patients for in-home use also require HME licensure.
What Is the Florida Law of Return of Durable Medical Equipment?
There are a number of laws regarding the disposal of durable medical equipment in Florida — laws that protect the environment by demanding recycling and upcycling when possible.
In most cases, healthcare businesses are not allowed to dump durable medical equipment in the landfill. Florida has strict laws about the disposal of home medical equipment, and violators are charged with stiff fines.
What Is the Penalty for Violating These Florida Laws?
In Florida, healthcare businesses that violate laws on durable medical equipment face hefty fines and fees on top of legal costs.
For example, if you rent or sell durable medical equipment without proper licensure, it is punishable by a fine of $500 to $1000, and each day that the equipment is rented out is identified as a separate offense. Over the course of years, this could add up to millions of dollars.
Is Your Business in Violation of Durable Medical Equipment Laws in Florida?
If your business ever rents or sells home medical equipment to patients, it is a good idea to have all your processes and protocols reviewed by a healthcare law firm that can ensure that you are in compliance, starting with proper licensure.
Business law lawyers play an important role in protecting healthcare organizations. Through their work and expertise, lawyers ensure that executives make their concerns and demands well known. And lawyers also ensure that contracts are solid and clear, so everyone knows what to expect.
While a business law lawyer could help you with almost any type of problem, three issues tend to dominate our work at Florida Healthcare Law Firm.
3 Common Changes We Handle
When you’re working as a business law lawyer in Florida, you’re typically dealing with dozens of different clients with unique wants, needs, and capabilities. But strip away superficialities, and these clients tend to struggle with the same types of issues.
Acquisitions. Imagine this: You’ve just read about small pharmacies getting squeezed due to changes in Florida Blue plans. You’d like to buy one of these businesses. A business law lawyer could help you draft up an enticing and enforceable offer.
Partnership shifts. You started your business with a co-owner, and now that person wants to retire. A lawyer could help you craft an exit strategy and draw up new paperwork to change ownership legally.
Mergers. In healthcare, these deals are often huge. For example, the Teledoc and Livongo merger was worth $18.3 billion. A business law lawyer could ensure no mistakes are made in these high-stakes deals.
How to Work With a Business Law Lawyer
A legal professional is there to advise, guide, and protect you. Everything you share is protected. Hire someone you trust, so you can disclose documents and trade secrets freely without worry of theft or retaliation.
In addition to open communication, business law lawyers in Florida appreciate your discretion. If a lawyer is handling your case, don’t talk with the other party or the press. Let your team protect you and do the work you’ve hired them for.
If you’re ready to work with a discrete, professional team of business law lawyers in Florida, contact us at Florida Healthcare Law Firm. We work exclusively within the healthcare field, and we’re ready to start now. Contact us.
As you have probably heard, Governor Scott signed Senate Bills 6A and 8A on June 23, 2017. What this means for practitioners is an increased opportunity to help patients that might derive benefit from treatment with medical marijuana. However, with increased opportunity comes increased scrutiny. Although these laws open up treatment options, practitioners need to ensure they strictly abide by the statutes and rules to be implemented by the Department of Health (“Department”). The Department has already published notice of the first conference call on Senate Bill 8A and emergency rule making authority, with the first conference call scheduled for Friday, July 14, 2017. Practitioners should also keep in mind that marijuana is still a schedule 1 controlled substance under federal law, thus, insurance companies are not covering treatment with medical marijuana. read more
By: Jeff Cohen, Florida Board Certified Healthcare Lawyer
Followers of the addiction treatment industry should be on high alert after the arrest of Christopher Hutson of Whole Life Recovery. The arrest marks the first arrest of any industry provider utilizing the state Patient Brokering Act (PBA). Relying solely on the allegations, the arrest is based on a business relationship between the provider and sober homes. Discussion in the “case management agreement” referred to in the arrest affidavit circles around some key allegations that include or imply (1) payment for patient referral, and (2) services by sober homes paid for by Whole Life which were not actually performed.
Serious industry providers absolutely MUST be well educated by lawyers who have years’ experience dealing daily with issues that include the federal Anti-Kickback Statute (and safe harbors), the bona fide employee exception to the AKS, the PBA and how insurers and regulators (inside Florida and outside Florida) interpret and apply such laws. Any contract (like the sort of agreement referred to in the arrest warrant affidavit) that isn’t preceded by careful client education about the laws, the options and risks of each option is just reckless. Clients who are well educated will understand things like— read more
Healthcare providers have heard the HIPAA disaster stories: a laptop containing patient information is left on the counter at the coffee shop; a thumb drive with patient files goes missing; a rogue employee accesses patient information she has no business accessing; hackers get into a practice’s server and hold the patient information for ransom.
HIPAA is a federal law designed for safe disclosure of patient’s protected health information. The news headlines showcase giant penalties for violations. However, Florida healthcare providers should also know that Florida has its own consumer protection statute, called the Florida Information Protection Act. So while you’re busy worrying about your HIPAA exposure in any of these situations, remember that there is potential State exposure as well.
So what should a healthcare provider do if it believes there has been a hack or some other unauthorized disclosure? Responses vary based on the situation presented, but below is a good jumping off point: read more
For many years, medical providers and regulators have wrestled with whether Advance Registered Nurse Practitioners (“ARNPs”) and Physician Assistants (“PAs”) should be able to prescribe controlled substances. This past legislative session, several bills were signed into law allowing ARNPs and PAs to prescribe controlled substances subject to several limitations and restrictions. This article will set forth a broad overview of the bills. However, if your practice intends to use ARNPs or PAs to prescribe controlled substances, we strongly recommend that each practitioner is educated about the boundaries set forth in the new law. For instance, there are restrictions on prescribing certain controlled substances in certain circumstances, prescribing controlled substances within a pain management clinic, and prescribing controlled substances for persons under age 18. It is important that all practitioners are properly educated prior to engaging in prescribing or dispensing any controlled substances.
Advance Registered Nurse Practitioners
ARNPs may prescribe or dispense Schedule II, III or IV controlled substances if they have graduated from a program leading to a master’s or doctoral degree in a clinical nursing specialty area with training in specialized skills and have completed 3 hours of continuing education on the safe and effective prescription of controlled substances. ARNPs must limit their prescriptions of Schedule II controlled substances to a 7-day supply. However, this restriction does not apply to psychiatric ARNPs who are prescribing psychiatric medications. read more