What’s the deal? Do I need a sterile hood for my IV clinic?

With the growth of IV hydration therapy, many clinic owners wonder, do I need a sterile hood if I’m mixing bags in the clinic? Well, that depends. It depends on whether you are a physician, mixing outside of a manufacturing instructions, and more.

The FDA and state Boards of Pharmacy govern “compounding” facilities. When a facility is mixing, adulterating, or diluting, they’re considered to be “compounding”. This is not the case if you do so in accordance with directions on approved labeling provided by the product manufacturer.

Physicians fall under an exception, however. The FDA says that licensed physicians are exempt from 503A pharmacy laws and the FD&C Act if they are done in a clean and sterile environment, compounded based on a valid prescription, and compounded by the physician. So, it has to be compounded for a patient who presents with an immediate need for the product or because “it would not be safe for the patient to take the drug home for self-administration, and it would be more convenient for the physician to have the drug in his or her office to administer immediately upon diagnosis, rather than asking the physician to order the drug and have the patient return to the health care practitioner for administration.”

This guidance would exempt licensed physicians from requirements to utilize a hood for compounding.

If you’re not a physician, then you should follow FDA guidance on safe practices for compounding.

Wait! Why you must have your marketing contract reviewed before signing it.

Starting a new business? Opening a new profit line in your existing business? Thinking about hiring a marketing team to help drive clients your way? Be cautious, because a signed contract means nothing until you have a dispute. And if you didn’t take a close look at that contract before signing, but now the relationship has soured, you’re not going to have an easy route forward.

So what should you look for specifically?

  1. Early Termination Options and Penalties
    • What if the marketing company isn’t performing well? How can you terminate early? Are you locked in for a year? What type of penalty, if any, are you subject to for early termination? If you don’t review and negotiate these terms before signing, you might be locked in for a full year of services or face a penalty for terminating early (and not get any services, whether good or bad).
  2. Restricted Terms
    • Healthcare businesses are some of the most heavily regulated businesses in the U.S. With the continued growth of social media enterprises, so comes new regulations. For example, Google and Facebook have significant restrictions on the adwords that can be used in connection with healthcare businesses. More significant, are the limitations on terms or phrases that are used. You must ensure that the company you contract with is aware of these terms and can actually deliver what they promise without violating these terms because if they do violate them, its your business that gets suspended, or banned, from advertising on such sites.
  3. Payment Terms
    • What are the payment terms and what does it include/exclude? Is there a minimum spend? What portion of that is attributable towards a management fee versus ad spends? Does the fee take into account patient volume or value of sales? If so, you may be violating a Federal or State healthcare regulation (which often carry criminal implications!). It is so important that these terms are not only clear but legally compliant.

Facebook Advertising No-No’s for Healthcare Businesses

Amanda Howard, Esq.

Facebook has a long list of things it doesn’t allow to be posted. While some things are obvious, others are not. And what gets flagged may be confusing to posters. That’s not surprising, as Facebook is known for using bots to review ads for denial or approval. The problem with using bots is that bots may flag suspicious information, and only a human can understand the true context of it. Fortunately, if you appeal a decision to deny your ad, Facebook will usually allow for human review. To bypass this and just for better practices, before your practice or business posts an ad on Facebook, be aware of what’s not allowed on Facebook to lessen your chances of being denied:

  1. You generally can’t talk about drugs. Illegal drugs are an absolute no-no, and so are prescription drugs. Talk about over-the-counter drugs is subject to strict guidelines.
  1. Facebook blocks “adult content” and “adult products and services.” Facebook has rejected ads related to sexual health issues, including reproductive health products/services, in some instances with good reason and others not. This is a situation in which making sure a bot isn’t the final decision-maker is important. 
  2. Facebook blocks “unsafe substances,” including anabolic steroids, DHEA, Ephedra and human growth hormones. While some of these substances are illegal, others, like DHEA, are not and help produce hormones which some individuals may medically need.  
  3. Facebook blocks “negative ad experiences,” meaning ads can’t draw attention to beauty or health conditions as such wording or imaging may create unexpected experiences.
  4. Facebook blocks sensationalized language and language bait. Be wary of posting ads that say things like “7-ways to change your life” or “5 ways to cut 1 lb a day.”
  5. Facebook also blocks personal attributes, such as an ad that talks about physical or mental health or condition. Stay away from wording like “Have you been diagnosed with cancer? Come to our clinic for treatment.”

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to help healthcare professionals and businesses comply with all laws so that they can be safe in their profession and practices.If you would like to learn more about advertising as it relates to your practice or business and get advice on how to proceed, contact us at Florida Healthcare Law Firm to set up a consultation today.

Florida Abortion Law

setting up your office to work remotely during a crisis

Florida is one of two states that block abortions after 15 weeks’ gestation. While 15 weeks, or a little beyond the first trimester, may seem like plenty of time to make the decision and undergo the procedure, the law does not provide exceptions for pregnancies that came about due to rape, incest, or sex trafficking.

Only about 2 percent of abortions in the state of Florida occurred after the 15-week mark in 2019, according to the Centers for Disease Control and Prevention and AP News. The populations most likely to be impacted negatively by the law are those who need time to put together the money to pay for an abortion, those who are so young or unhealthy that they do not realize they are pregnant until after the 15-week mark, and those who are in domestic violence situations and may need time to set up the appointment and cover the cost.

How Will the New Abortion Law Affect Physicians in Florida?

The situation is a difficult one for doctors as well as for the women who may be in need of an abortion in Florida. Physicians who break the law and provide an abortion outside of the terms and conditions face a fine of $10,000 for each violation and the possibility of losing their medical license.

Keeping Up With the Laws

It is a good idea to stay abreast of updates as the laws regarding abortion continue to change in Florida. A contingent of the population and some officials holding office are working hard to change the laws, calling them a violation of the state constitution.

If the current iteration of the law contrasts with your current policy, changing that policy will help you to stay within the bounds of the law. Updating all standards and convening a meeting of the entire staff will help to ensure that patients are getting the same information from all employees at every level.

How Do I Respond to Litigation or Notices From the State Regarding the Florida Abortion Law?

If you have received a notice from the state or have been served legal paperwork due to an alleged violation of the abortion law in Florida, it is important to connect with legal help as soon as possible.

At the Florida Healthcare Law Firm, we focus solely on serving the medical community in South Florida. We can help you keep up with the changes in abortion law as well as changes in all laws that impact your clinic, office, employees, and patients. Additionally, we can help you to overhaul your business plan to support the legal changes. Should you face charges along the way, we can help you to address the situation proactively.

Contact Florida Healthcare Law Firm to set up a free consultation.

Optometry in the Telemedicine World

Amanda Howard, Esq.

During COVID-19, many doctors and patients opted for telehealth/telemedicine appointments instead of in-person appointments. The trend has seemed to stick. Today, many patients and providers prefer telehealth/telemedicine appointments. The convenience and efficiency of such appointments is hard to beat, especially when certain providers have the capability to deliver the same or similar quality of in-person meetings through teletechnology. Patient/provider interactions that do not always require physical contact with a patient or equipment tend to be better suited for telemedicine. It’s not surprising then that mental health clinicians, gastroenterologists, neurologists, and radiologists used telemedicine the most during COVID-19 out of all major specialties.

It’s also not surprising that optometrists used telemedicine the least. The question permeating the optometry world is: are telemedicine appointments equivalent to in-person appointments? Are there technologies available that allow optometrists to conduct eye exams? Even if there are, do the technologies available meet federal and state standards of care? Whether a technology is available or suitable is two different things. While taking a patient’s history and examining pupils to a certain degree is doable, conducting refractive tests, retinoscopy’s and visual acuity tests have inherent limitations.

On the other hand, consider the situation in which an optometrist is out of town, and a patient has a swollen eyelid. The patient’s description of the problem alone may not be enough to distinguish between an allergy or a stye. That’s where telemedicine comes into play. Whereas in years past, the patient would have to wait for the doctor to return to the office, and then trek to the office on their appointment date, wait to see the doctor, and hope that he wasn’t sitting and waiting for hours, telemedicine can allow for an almost-instant visual inspection and advice on the best care of management.

There’s no denying the pros of using telemedicine in the optometry field. The issue is it allows for the required patient standard of care in all cases. In some cases, optometry telemedicine simply can’t. At least for now.

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to help optometrists comply with all laws so that they can be safe in their profession and practices.If you would like to learn more about optometry as it relates to telemedicine and get advice on how to proceed, contact us at Florida Healthcare Law Firm to set up a consultation today.

Zoning & Use Issues For Healthcare Practices

Amanda Howard, Esq.

If you’re thinking about starting your healthcare practice from the ground up or purchasing an established practice and its real estate, zoning and use issues should be on your mind. It’s critical to understand what activities are allowed to be done, and perhaps more importantly, what activities are NOT allowed to be done on your soon-to-be property and the restrictions your building may be subject to. To figure these things out, you can research appropriate building codes and zoning information on your county’s property appraiser website and use interactive maps or obtain a zoning report or request a letter from your local planning and zoning office, which will summarize existing code requirements and highlight areas of potential non-compliance. In cases where a particular zone does not permit healthcare facilities, a zone change may be possible (but that’s a topic for another time).

Some questions that are important to ask in determining whether a particular property is suitable for your practice are as follows:

  1. Is zoning impacted by county or city regulations?
  2. What is your type of practice defined as under county or city zoning regulations?
  3. Which districts or areas permit your type of healthcare practice?
  4. Must your practice be outside of residential areas?
  5. Is your practice limited to a certain amount of square feet?
  6. Is your building subject to certain aesthetic requirements?
  7. Is there a setback requirement for your building?
  8. Can the services you provide only be provided during certain hours?
  9. How much parking is your practice allotted?

These questions may never cross a buyer’s mind. However, not knowing their answers and others may cause a major headache during the closing process and potentially even kill a deal to purchase a property. That’s why it’s important to get advice from a professional.

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to help healthcare professionals comply with all laws so that they can be safe in their profession and practices.If you would like to learn more about zoning and use issues and get advice on how to proceed, contact us at Florida Healthcare Law Firm to set up a consultation today.

What Is a BAA Agreement?

direct primary care agreements

A BAA agreement is designed to protect the private identifying medical information that belongs to patients but may need to leave the office or clinic in which it was created. This agreement is drawn up between a medical provider’s business and/or hospital and other individuals or businesses who are not directly employed by that provider or hospital but may have cause to come into contact with these documents through the course of their work.

The goal is always to protect the patient, but these agreements can also serve to protect the healthcare providers who contract with outside businesses should there be an issue with medical privacy.

What Is a BAA Agreement?

A BAA agreement is not a simple document whereby the business associate in question agrees to be careful with all patient data. Rather, it is a lengthy and specific document that outlines exactly what it means to protect patient privacy, how the business associate is and is not to handle patient medical records, and what the penalties will be should they violate the agreement.

The following is included in a BAA agreement:

  • What PHI will be accessed by the business associate
  • The requirements for protecting each variety of PHI expected of the business associate
  • The explicit expectation that the business associate will not share any protected health information outside of the confines of the agreement
  • The outline of training required of the business associate and the log of completion of that training
  • The details of what penalties will occur if a data breach is identified
  • How the BAA agreement should be terminated, if appropriate
  • A detailed process for destroying or returning PHI, if appropriate to the process

Why Is a BAA Agreement Necessary?

Many healthcare businesses work with the assistance of outside businesses in order to efficiently run the backend of the business and provide care to patients. For example, a clinic may require an outside company to transport test specimens to or from a lab, to manage x-rays and scan and store them after they are taken, or to otherwise attend to some of the details of healthcare management.

Should that organization or one of its employees put the healthcare data they use at risk, the healthcare organization who employed them will be liable for any harm caused if there is not a BAA agreement in place that clearly outlines the expectations and responsibilities of the business associate.

How to Create a BAA Agreement

If you or your organization works with outside organizations or businesses, it is a good idea to create a BAA agreement that is specific to the business. Make sure you are covered and get the support of Florida Healthcare Law Firm in this process to make sure that the agreement is ironclad.

HITECH in Healthcare

creating a healthcare app

The Health Information Technology for Economic and Clinical Health (HITECH) Act is one part of the American Recovery and Reinvestment Act (ARRA), a piece of legislation designed to stimulate the economy. Additionally, its goal was to improve the management and protection of healthcare documents.

Since its inception in 2009, there have been a number of modifications, many of which include detailed explanations of what a violation of HITECH looks like and the penalties for those violations.

What Is HITECH in Healthcare?

HITECH in healthcare stands for Health Information Technology for Economic and Clinical Health. It aptly describes the original intent of the legislation, which was to create jobs and help to spread the use of technology in hospitals and other healthcare settings to manage patient records.

Before the inception of HITECH, only about 10 percent of healthcare facilities maintained patient records electronically. Instead, most had files packed full of medical records going back decades, all of which could be easily accessed by anyone behind the counter.

It was easy for professionals to get busy and leave files on desks, grab the wrong file when intaking a patient, or file a new document in the wrong file and thus put those records and the information they contained at risk.

With the implementation of healthcare technology, medical providers were able to access records via computer, input their notes directly into that file, making them immediately accessible (and legible!) to patients and the next provider to care for the patient within the healthcare complex.

How Has the HITECH Act Impacted Healthcare?

HITECH has helped to improve accountability when it comes to managing patient files. Computers can monitor who accesses which files and when as well as what actions were taken on those files, making it easier to identify those who were transferring files carelessly or otherwise exposing them or putting them at risk.

In response, four penalty tiers have been introduced along with specific minimum and maximum fines per violation. Currently, those penalty tiers include the following:

  • Tier 1: Lack of Knowledge
    These violations are incurred due to inexperience or lack of understanding of how a system works or what should be protected. Penalties are the least severe, ranging from a minimum of $120 to $30,113 per violation with a max penalty limit per year of $30,133.
  • Tier 2: Reasonable Cause
    These violations may have occurred because the individual or organization thought they had cause for sharing the information. Fines range from the minimum $1,205 to $60,226, with a max annual penalty limit of $120,452.
  • Tier 3: Willful Neglect
    Purposefully breaking privacy protection of patients or blocking them from access to files is punishable with a minimum fine of $12,045 and a max penalty of $60,226 per violation, with a max annual penalty list of $301,130.
  • Tier 4: Willful Neglect Not Corrected Within 30 Days
    Should the willful neglect go uncorrected for more than a month, penalties get severe. Minimum penalties per violation go to $60,226 and maximum penalties can be more than $1.8 million, with an annual penalty limit of $1,806,757.

HITECH Violation Support

If you are facing fines and litigation due to an alleged HITECH violation, reach out to Florida Healthcare Law Firm for assistance today.

Keeping Elective Services Under One Roof – Primary Care Meet MedSpa

Carlos H. Arce, Esq. / Chase E. Howard, Esq.

Sustaining a healthcare business in today’s medical industry calls for both ongoing innovation and quite a bit of ingenuity. The question of what can be done to enhance patient retention while keeping patients interested and loyal to a practice comes down to what is legally permissible from a compliance standpoint. A prime example of value add for an existing practice are the benefits that patients in the geriatric population are often offered, everything from cardiologists, chiropractors, physical therapists, dentists, orthopedic, pulmonologists and most recently, to med spa services.

Vendor Status

Allowing specialists to treat patients in a practice has always been a form of benefit to patients. Assuming the patients require a medical service which is medically necessary, they are treated. The obvious key is making sure it is done legally. Under the federal and state self-referral laws, it is imperative to comply with certain exceptions when entering a referral arrangement between providers. The most accurate away to ensure legal compliance when offering specialist services in apractice is via the “Rental of Office Space” exception. Space is leased to the specialist on a basis which accounts for the guidelines, the specialist provides services, the insurance pays them or the patient pays them, and the patient receives rounded care.

But can this be done for elective procedures, such as MedSpa’s? The answer is yes. Most patients 18 and over are seeking additional elective medical procedures, from IV hydration to Botox. Primary care providers may be able and qualified to perform some of these services, but consideration must be paid regarding taking on the risk of performing services which may be outside of one’s wheelhouse.

Bringing in a med spa vendor who can provide services to an existing patient base sounds like a wonderful patient retention tool. If the legal parameters surrounding this arrangement are followed, providers not only can be legally compliant, but can also add a retention benefit to their practice.

Mobile MedSpa

With the push in healthcare to make services mobile, medspa owners may be wondering how to transport the business to conduct services elsewhere. The short answer is finding the right relationship to support the opportunity. Which services could a medspa offer on a “mobile” basis? The answer is, it depends. Generally, services provided in home to patients are allowable but might require a home health agency license depending on the services. Services provided at another clinical location, such as a primary care practice, require very little in the way of licensure. Specifically, a Medspa could send its providers to another location on a limited basis to service that practice’s patients so long as the providers are properly “supervised” and the patients are properly billed. The providers could utilize the other clinic’s physician for supervision, eliminating the need for any specialty supervision as required by Florida law and could utilize extended staff for patient intake, room prep, and check out.

The biggest hurdle for this arrangement would be the compensation arrangement, which, as described above, would require strict compliance with the law to ensure no illegal referral schemes or fee-splitting occurs.

Summary

With multiple MedSpa’s and Aesthetic clinics popping up through out the country, why not considering subleasing space rather than adding that additional unnecessary overhead. Some MedSpa’s will inevitably be better off treating in their private space, but that doesn’t mean it’s the only way these added services can be accomplished.

Holistic Dentistry – What is it and what’s happening in the industry?

Holistic, or Biological, Dentistry is dentistry that takes a whole-body approach to oral healthcare. This type of dentistry emphasizes prevention and conservation through lifestyle changes and non-pharmaceutical treatments. It discourages early invasive surgeries, mercury, fluorides, and other “toxins”. Biological dentists may be members of the International Academy of Biological Dentistry and Medicine.

Biological dentistry focuses on a mouth-body connection, rather than just simply treating the explicit issue a patient may face. Biological dentistry focuses on reducing inflammation, stress, and non-natural products while emphasizing whole body wellness.

What principles identify biological dental practices?

  1. Mercury-free and mercury-safe
  2. Fluoride-free
  3. Focus on whole-body health
  4. Chemical free whitening
  5. Focus on prevention
  6. Most natural and least invasive
  7. Avoids root canals
  8. Biocompatibility testing for dental materials
  9. Emphasis on nutrition and nutritional counseling
  10. Ozone therapy

How does holistic dentistry differ from traditional dentistry as it pertains to the law? Not at all, in reality. The practice of holistic dentistry is governed by the Florida Board of Dentistry still and all such laws and regulations apply, including Florida’s prohibition on the corporate practice of dentistry (I.e., the ownership of a dental practice by a non-dentist).

The same applies to entity selection – licensed dentists can choose to operate under a “PA” or PLLC”.

You could also add on additional services to your dental practice that might be considered medical, so long as you engage the appropriate licensed providers to deliver those services. For example, While most medspas provide full body aesthetic treatments, Dentists are limited to providing treatments that are with her or his scope of practice. For example, Botulinum Toxin-A may be prescribed by a dentist, but is limited to the face and neck of patients. This also means that for nurse practitioners working under the supervision of a dentist, they too are limited in practice. While certain other treatments don’t require any specific medical license or training, dentists should evaluate the type of treatments they wish to provide or supervise to ensure it is within their scope of practice.

The growth and acceptance of biological dentistry is going to continue to expand and dentists should position themselves to incorporate these practices in into their practice as they look to grow and possibly sell in the future.