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.
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).
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?
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.
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.
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.
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.
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.
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.
on May 26, 2021 Comments Off on Webinar | The Ins and Outs of The Medicare Billing, Overpayment, & Appeals Process
If you are a provider who has to submit claims to Medicare in order to get paid for the services you and your office provide this presentation is for you. This webinar will provide an overview of the Medicare Billing, Overpayment & Appeals process and more specifically I will help answer questions for you such as: How long do I have? What do I do next? Why is that the best choice? Exactly how do I do that? Join healthcare law attorney Zach Simpson for this free webinar.
Medical spas and hormone replacement therapy (HRT) clinics are gaining popularity. Although these are non-traditional healthcare businesses, they still must operate safely and efficiently like any healthcare business in order to be successful. In this webinar, business and health attorney Chase Howard will go over specific supervision requirements and restrictions in these types of healthcare business spaces.
In this webinar, board certified healthcare lawyer David Davidson will update healthcare providers on actions taken by the Biden administration. Tune in for changes and trends that healthcare providers should be aware of.
Review EOBs and determine where denials are originating and their root cause
While reviewing EOBs practices need to determine if a trend can be established that identifies the root cause for why claims are being denied. Trends can be established by asking if most denials are originating in your patient access and registration departments, or are denials occurring because of insufficient documentation, or due to billing or coding errors?
The healthcare industry is doing its level best to keep fax machine manufacturers in business. Because fax machines are considered to be HIPAA compliant, it’s easy to keep them humming along. Paying for expensive toner, electricity and the telephone line attached to the wall behind the machine is just the way we’ve always done it. But that telephone line should give you enough reason to consider your options.
AT&T built and owns the copper telephone network that provides the analog signal required for T1 lines, traditional telephones, fax machines, credit card machines, postage meters, alarms and elevators. That service is known as POTS – Plain Old Telephone Service. Maintaining that antiquated network is costly and inefficient for AT&T so they will retire POTS in the near future. All services will eventually run over fiber optic cables and your equipment may have to change to keep up. You may have received a letter telling you about this transition but probably ignored it or did not even open it thinking it was a solicitation. So, how does AT&T get your attention if you won’t read their letter? Check your phone bill!
Healthcare fraud continues to be a significant priority for the U.S. Department of Justice. On February 24, 2021, the DOJ’s Criminal Division Fraud Section published its annual “Fraud Section Year in Review 2020.” While the Fraud Section has three separate enforcement units, the Health Care Fraud (HCF) Unit is responsible for all enforcement activities in the health care industry. The Unit’s focus is to protect against fraud and abuse in federal health care programs and recoup illicit gains.
During 2020, the HCF Unit operated 15 strike forces in 24 federal judicial districts throughout the U.S. The efforts of these strike forces led to charges against 167 individuals alleging $3.77 billion in fraudulent charges for health care paid for by federal and state programs. This should cause any health care provider to stand up and take notice. And enforcement in the health care industry is not likely to go away soon with so many schemes ripe for the government’s picking and generating recoupment on behalf of the federal health care programs.
Here are couple of the latest schemes that have landed pharmacies, pharmacists and other health care professionals squarely in the crosshairs of federal enforcement:
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.