FDA Stem Cell

A big update in the stem cell industry last week as a California judge issued a favorable order on behalf of a California based stem cell treatment provider. California Stem Cell Treatment Center, Inc., is a California based medical company offering SVF surgical procedure and MSC Surgical procedures. A few years ago, the Food and Drug Administration (“FDA”) sought an injunction against the Company to prevent them from performing these procedures because the FDA claimed that the procedures included the adulteration of drugs which were then re-injected into the patient and thus were classified as “drugs” and therefore under the FDA purview. The Company argued, however, that the SVF procedure and MSC procedure are not “drugs” as defined by the FDA and there that the procedures don’t fall under the FDA’s definition/prohibition regarding adulteration and misbranding of products. The Court allowed the trial to move forward, and the Company provided support of their position which ultimately was successful. The Judge agreed that the procedures and the subsequent cells were not “drugs” and went on to further state that the SVF procedure qualifies for the “Same Surgical Exception” under the Food Drug and cosmetics Act (“FDCA”) even so.

The ruling in this case reinforces the Florida based company, US Stem Cell, position and is contrary to the ruling made in its case back in 2019. The Court also made it clear that the FDA does not have the ability to interfere with the practice of medicine of physicians, as limited by Congress and the FDCA. The Court, through its ruling, removed some of the power of the FDA in these types of cases, essentially saying that they do not have oversight on surgical procedures (which the Court believes these procedures constitute).

So, what does this mean? It certainly pushed back on the FDA and its reach big time. It means the FDA will either take a step back from stem cell regulation and allow these clinics to operate with less scrutiny, or it means the FDA will work with Congress to update their governing statutes and expand their purview. For the time being, it keeps the FDA at bay.

What Is Protected Health Information?

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PHI in healthcare stands for protected health information, but it is a term that is both vague and general. As a result, it can cause understandable confusion for both patients and healthcare providers.

It is a term that is generally connected to conversations about the Health Insurance Portability and Accountability Act (HIPAA), a piece of legislation designed to protect the private healthcare and medical information of patients.

What Is PHI in Healthcare?

When it comes to the protected healthcare information protected by HIPAA, the following areas are covered:

  • Demographic information
  • Medical history
  • Results of medical testing
  • Health insurance information
  • Any identifying information that connects a patient to a healthcare service or healthcare coverage provider

Essentially, any information that connects a person to a medical issue through testing, treatment, doctors’ notes, or other areas must be protected.

This not only means that sharing that information with other sources is off limits without the consent of the patient, but also that great care must be taken when transmitting medical records lawfully over email or other means, so they are not lost, hacked, or inadvertently fall into hands that were not the intended recipients of that information.

It also means ensuring that the patient always has the ability to access these same records and the option to request revisions as appropriate.

How to Protect Healthcare Information Under HIPAA

Healthcare providers, health insurance providers, their business associates, and those responsible for the transportation of PHI are all accountable for the protection of this information.

In order to do this lawfully, it is necessary to do the following:

  • Get authorization to disclose protected health information from the patient, usually in the form of a consent contract or waiver.
  • Get permission from the patient to access privilege to protected health information that was generated in other offices, facilities, or organizations.
  • Avoid the destruction of protected health information that may stop the patient from having full and complete access to their medical records and healthcare information.
  • Gain authorization to use and disclose protected health information to anyone but the patient, including concerned family members. Even admitting that a patient is receiving treatment and has records to access at a medical facility is not allowed unless the individual person has been approved by the patient.

It is important to note a few things in regard to the protection of personal medical information.

All authorizations to share information needs to be in writing and kept on file. If the patient decides to revoke authorization at any point, they will need to update the information, even if it is a court decision, such as in the case of divorce or loss of legal child custody.

It may also be of interest to note that HIPAA laws no longer protect an individual once it has been 50 years since their death.

If you need assistance managing a HIPAA claim made against you or pending litigation, contact Florida Healthcare Law Firm for assistance today.

Florida’s Prohibition on the Corporate Practice of Optometry

Florida prohibits the corporate practice of optometry (CPOO). In contrast to the provisions of Florida’s Medical Practice Act, which governs medical doctors, Florida’s Optometry Practice Act, which governs optometrists, expressly prohibits any corporation or other business entity from engaging in the practice of optometry. Likewise, Florida’s Optometry Practice Act also prohibits any optometrist from engaging in the practice of optometry with any corporation or other business entity. The purpose of this law is to prevent non-optometrists from having authority over and controlling the professional judgment of optometrists.  

Florida, instead, allows optometrists to organize as a professional service corporation (PA) or a professional limited liability company (PLC). Under a PA or PLC, only an optometrist or multiple optometrists may be members of such entities. For example, physicians (MD or DO) may not form a PA or PLC with optometrists.

Despite the above, Florida law allows optometrists to “associate” with a multidisciplinary group of licensed healthcare professionals, the primary objective of which is the diagnosis and treatment of the human body. In other words, Florida law seemingly allows optometrists to be employed by, contract with, or be an owner of an entity composed of other licensed healthcare professionals. As there appears to be no law against whether other licensed healthcare professionals can form entities other than PAs or PLCs (except for optometrists, dentists and chiropractors), Florida law may allow an optometrist to join an entity comprised of a multidisciplinary group of licensed healthcare professionals, the primary objective of which is the diagnosis and treatment of the human body, whether that entity is an LLC, corporation, or another entity form.

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 the corporate practice of optometry in Florida and get advice on how to proceed, contact us at Florida Healthcare Law Firm to set up a consultation today.

What Is the HIPAA Privacy Rule?

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The HIPAA Privacy Rule was first proposed in 1999. Over the decades, it has seen a number of modifications as the interests of patients have evolved over time.

With the COVID-19 pandemic, HIPAA has faced new challenges due to the sometimes conflicting need to protect public health while also protecting the privacy of individual patients.

Often, healthcare providers are caught between maintaining legal standards and providing patients with the best care possible. Sometimes, their choices impact the greater good as well when the public may be at risk of exposure to a viral illness like COVID.

In these times, it is often valuable to go back to the primary source and reconnect with the wording and intent of laws like the HIPAA Privacy Rule rather than make potentially life-altering choices based on hearsay or social convention.

What Is the HIPAA Privacy Rule?

The HIPAA Privacy Rule protects the confidentiality of all medical records and health information that is individually identifiable. Essentially, the rule limits the use of these records without the consent of the patient, but it also requires the provision of access to all healthcare and medical records for the patient along with the ability of that patient to transmit those documents to a third party and to request corrections if appropriate.

Does COVID Impact the HIPAA Privacy Rule?

COVID does not necessarily change the protections provided by HIPAA because there are already provisions within HIPAA that allow for the sharing of medical information, including identification information, under certain circumstances.

Under HIPAA, the name and other identifying information of a patient who is diagnosed with COVID may be shared by the provider with law enforcement, first responders, and/or public health agencies without patient consent when the following is true:

  • It is necessary to provide treatment.
  • Notification is required by law.
  • Notification is required to prevent or control the spread of the illness.
  • First responders or other medical professionals may be at risk of exposure to the illness.
  • The individual is in custody of law enforcement or a correctional institution.

Essentially, if the care and treatment of the patient, protection of medical providers who are providing treatment to that patient, or the well-being of public health is at risk due to a patient’s diagnosis with any infection or disease, including COVID, sharing of personal information may legally be done by medical providers.

How Can Medical Providers Ensure HIPAA Compliance & Protection From Related Litigation?

Unfortunately, many patients do not understand the nature of HIPAA and/or its intent and bring lawsuits against medical providers who they feel have violated their rights by sharing their COVID diagnosis. If you are facing such litigation and would like help, Florida Healthcare Law Firm can assist you. Call now for a consultation.

The Management Services Organization (MSOs) Role in California

California prohibits the corporate practice of medicine (CPOM), a broad legal doctrine prohibiting non-licensed persons, including individuals and business entities, from practicing medicine. The CPOM doctrine arises from the idea that those with similar values and desire to uphold similar ethical principles should control the business of medicine. In other words, the purpose of the doctrine is to prevent non-licensed persons from influencing medical treatment decisions that could cause a physician to divide his or her loyalty between generating profits and delivering quality care.

The prohibition on CPOM is why, in California, the only permitted corporate form for an entity that practices medicine is a physician-owned Professional Corporation (PC). Per California law, other healthcare professionals, such as RNs or PAs, can collectively own up to 49% of the PC. However, a physician or group of physicians must own at least 51% of the PC.

What does all that mean? Unlicensed persons can never own any part of the PC. So, how can an unlicensed person profit from the PC? They can create a Management Services Organization (MSO) and contract with the PC to manage the administrative and non-clinical operations of the medical practice. For example, the MSO can oversee a non-clinical HR department, the finances of the PC, and marketing efforts. Under such an arrangement, it is critical that the MSO has no control or authority over the PC and that payment to the MSO is not linked to the MSOs referral of patients to the PC. In simpler terms, the PC must only pay the MSO the fair market value for the services it provides.

An MSO can be a valuable tool for a PC and a good way for non-licensed persons to get around California’s prohibition on the CPOM.

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 the corporate practice of medicine in California and MSOs and get advice on how to proceed, contact us at Florida Healthcare Law Firm to set up a consultation today.

What Is a Certificate of Good Standing in Florida?

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A Florida certificate of good standing is a piece of paper that provides proof that you are doing all the right things in your business according to the state.

Officially known in Florida as a Certificate of Status, this PDF document can be submitted to companies you work with in other states to let them know that you do exist, are up-to-date on all your fees and licenses, owe no taxes, and are legally allowed to do business.

While this is not a requirement in the state of Florida, it is not difficult to obtain and can lend credence to your standing in the healthcare field, especially if you hope to enter into partnerships with other healthcare companies in Florida or out of state.

A Certificate of Status can also be helpful as you set up a business bank account in the state of Florida, especially if your business is new and has little documentation to show that it exists.

How to Get a Certificate of Good Standing in Florida

Getting a Florida LLC certificate of good standing or a Florida corporation certificate of good standing is a simple process that can be completed entirely online as long as you have a credit card or debit card to pay the fees associated with processing the document.

To begin, you will need to find your 6-digit or 12-digit document number. This number is connected to your business registration in the state of Florida and helps them to determine that you are in fact a legitimate business registered in the state.

To find your document number, go to the Florida Secretary of State’s Division of Corporations page and enter the legal name of your business in the search bar under “Search for Corporations, Limited Liability Companies, Limited Partnerships, and Trademarks by Name.”

With your credit card or debit card and your document number, you will go to the Florida Department of State website and click the button that says “Order a Certificate of Status.”

Next, you will do the following:

  • Enter your 6-digit or 12-digit document number when prompted.
  • Provide your email address in the appropriate block.
  • Pay for the fees associated with obtaining a Certificate of Status in Florida.
  • Look for an email in the next week from the Department of State that includes a PDF of your Certificate of Status.

It could take up to 7 business days to process, so if you require a more rapid turnaround, you will need to file in person, which will allow you to get a copy of your Certificate of Status that day.

Problems With Securing Your Certificate of Status?

If you are struggling with getting your Certificate of Status in the state of Florida, contact us at Florida Healthcare Law Firm for assistance.

No Surprise Act AKA Good Faith Estimates

The Centers for Medicare & Medicaid Services (“CMS”) effective January 1, 2022 has ramped up the new No Surprise Act (“NSA”) or often called the “Good Faith Law”. This law shall apply to group health plans, health insurers, health care providers and health care facilities (“Providers”). The NSA requires health care providers to be proactive and reactive as it relates to providing patients who are self-pay or shall receive out-of-network bills from their health insurance a pre-bill outlining the services they are intending to receive and could potentially receive.

Self-Pay

Self-Pay patients apply to a wide range of medical providers; therefore, the importance of this law is crucial for providers accepting cash patients. The provider will be required to transmit to patients itemized disclosures of the services offered at the facility, these disclosures are called “Good Faith Estimates”. A Good Faith Estimate will include various detailed terms that a patient must have upon request, or a provider will be required to inform a patient that said estimate is available to them when inquiring about services. The disclosure will be required at the front desk and on the providers website.

Out-of-Network

If a provider treats patients who have insurance coverage and is not in network with said insurance plan, the provider is subject to and will have to abide by the NSA.

The driving complaint by patients that lead to the institution of the NSA was surprise medical bills, which are essentially caused by balance billing. Balance billing occurs when a provider bills an amount or difference not covered by an insurance plan. Under the NSA, providers will have to implement the proper disclosure requirement of this practice, which must be presented to patients prior to the treatment. Providers will be required to obtain notice and consent forms signed by patients authorizing any additional billing not covered by the out-of-network coverage prior to providing said treatment.

Does Not Apply To

The NSA will not apply to vision or dental insurance plans which are solitary plans. However, if the vision and dental is an added benefit to a health plan it will be covered. The NSA will not apply to balance billing practices for those in the ground ambulance business. Providers who service Medicare, Medicaid, Indian Health Services, Veterans Affairs Health Care, or TRICARE shall not apply to NSA.

Penalties for Non-Compliance

A patient shall be allowed to dispute any bill charge in excess of $400 personally or through an independent third party, a “dispute resolution entity”, which shall determine the amount owed by the patient. An email shall be sent to the provider stating that a dispute has arisen, and the provider will be required to upload certain documentation surrounding the dispute. During a dispute resolution period, providers will not be allowed to move the bill into collection or threaten collection, if collection is already ongoing it shall be paused, late fees on the unpaid bill shall not be collectable, and any threats of retaliation against the disputing patient shall not be permitted. However, providers shall have the option to settle the claim with a patient directly abiding by the above, upon executing a settlement form. Failure to adhere to the NSA shall result in penalties up to $10,000 per violation.

All You Need to Know About IV Hydration Therapy Certification

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In the state of Florida, only those healthcare professionals who have completed training and certification in IV therapy may provide IV hydration therapy services regardless of the setting.

For in-home care providers as well as those working in nursing homes, hospitals, and other medical settings that provide emergency or ongoing care for chronic illness, achieving and maintaining certification in IV hydration therapy can open doors for employment.

Options in IV Hydration Therapy Courses

In the state of Florida, a 30-hour training course that provides both didactic training and skills training is required in order to become certified in IV hydration therapy.

In some cases, it may be possible to take the didactic portion (the academic classes that teach you everything you need to know about IV hydration therapy) online. However, all skills portions of the certification are required to be completed in person because you will need to practice starting an IV.

Because you are new to IV hydration, even if you have experience as a phlebotomist, the skills portion of certification must be completed under the supervision of someone who already has a current and valid IV hydration therapy certification. They will need to physically watch you complete the requirements of the training and sign off on your completion of the course.

Creating an IV Hydration Therapy Business Plan

Requests for in-home IV hydration therapy for patients with chronic illness or long-term care needs are growing in Florida and across the country.

Starting an IV hydration therapy business that travels to the homes of individuals who need treatment can be a positive way to serve the community and to create a sustainable business that helps you to maintain employment and provides employment to others as well.

There are a number of requirements for opening and maintaining an IV hydration therapy business that is in compliance with the state of Florida. While it may initially seem like a complex process, the support of a legal team who can help you understand what is required and on what timeline will help you to streamline the process.

Additionally, legal professionals in healthcare can assist you in the process of providing all the required documentation and forms, handle inspections, and keep up with deadlines so you never lose money or compliance status due to paperwork issues.

Starting an IV Hydration Therapy Career

If you are interested in starting an IV hydration therapy business or beginning to provide these services to increase your scope of practice, we can help. If you are currently certified as an IV hydration therapist, and you have questions about maintaining legal compliance in the state of Florida, reach out to Florida Healthcare Law Firm today.

The Future of IV Hydration Regulation is Now

IV hydration has virtually exploded onto the healthcare business scene in the past few years.  Fueled by patient interest in immune boosting and wellness, low cost and low clinical barriers to entry, the space is bursting with both single clinicians looking to replace working in hospitals to sophisticated and heavily capitalized business people.  And it is possibly a house of cards!

Why?  Because the business fervor in the industry is often outpacing quality and safety considerations.   We’ve seen this many times before, most recently in the addiction treatment industry, where competition filled the space driven by patient demand.  There, competitors did a poor job of defining quality (on a clinical level) and aligning with eachother to communicate with the media and state legislators.  They refused to stand together; and they got run over.  First by commercial insurers who enlisted federal law enforcement, then by broad criminal prosecution.  “Self-regulate or be regulated,” many advisers told them.   “You have to work together,” they were told.  They didn’t and the industry got crushed.   IV providers, take a lesson here!

Is this all just “wolf crying”?  Nope.  Take a look at Alabama.  There, the Board of Medical Examiners did their own study of the IV hydration therapy industry and found many providers where not clinically up to par.  They found there was no oversight or IV hydration regulation, that unqualified people were treating patients and that some products were concerning.  What did the state do?  It passed a ruling that requires a physician PA, APRN or certified nurse midwife to evaluate each patient and prescribe the right treatment and that medical grade IV fluid be used.  

Even the federal government has taken action in the space, in one case of a woman who received a vitamin bag at home and was hospitalized with multi organ failure.  The feds are entering clinics and investigating.  The Federal Trade Commission is issuing warning letters related to claims being made by clinics concerning the use of certain products.  European countries are even more vey active in regulating IV clinics.

It’s time to connect the dots here.  IV providers have to approach their business like any other healthcare service.  There must be vetted suppliers, clinical policies and procedures and clearly documented medical necessity and treatment notes.  And for there to be any stability or sustainability in the industry, providers will do especially difficult things:  first they employ sophisticated medical input and cooperate with competitors to define and maintain quality.  Second, they will form an industry voice to be a resource for media and government.   If they don’t define and maintain quality, it will be done to them…by lawmakers doing the best they can with limited (and even inaccurate) information.  

CNA License Renewal Florida

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Every two years, a Certified Nurse Assistant, or CNA, renews their license in order to maintain compliance with state law in Florida.

As long as they have provided CNA-related services for monetary compensation within the last 24 months, they are eligible to renew their license online and remain in the CNA registry.

Is it time for your certified nursing assistant license renewal?

Florida CNA License Renewal

It is easy to complete the CNA license renewal process entirely online in the state of Florida as long as you have a credit card or debit card to pay the fees associated with renewal.

To complete your CNA license Florida renewal, do the following:

  • Find your way to www.flhealthsource.gov and then click the button that says, “Renew a License.”
  • When prompted, enter your Personal Identifying Information to log in.
  • You will be prompted to confirm that your MQA services account email address is correct. If it’s not, update it. If it is, confirm and continue.
  • Once you are in the dashboard, you will see a button that says Renew My License ONLY if your license is set to expire within the next 90 days. If you do not see this button, come back in a few days.
  • If you see the button, click it. Follow the prompts to pay your fees and update your information. If you are late and the processing option is still available, you will be charged a delinquency fee on top of the usual fees.

If you do not have a debit card or credit card, you can complete the renewal process online and then print out the form and mail it in with a check or money order to:

Division of Medical Quality Assurance

P.O. Box 6320

Tallahassee, FL 32314-6320

Once processed, it may take up to 10 days for your request to be processed, your license to be printed, and everything to be mailed to you.

Note: Make sure to complete the renewal process by midnight on the night of the expiration of your CNA license in order to maintain licensure without interruption. If the deadline is missed, the license is placed into delinquent status. If it is not remedied, it will ultimately become null and void.

What if I Have Not Worked as a CNA in the Last 24 Months?

Florida nursing assistants who have not been actively working in the last two years will still have a license on file, but it will be marked as inactive. Should two biennial renewal cycles pass without the CNA taking steps to bring the license back into active status, it will likely be necessary to sit for a competency exam or reapply for their license and follow the current rules and regulations for gaining licensure in the state of Florida.

Need help renewing your CNA license or addressing any incorrect information attached to your licensure status? Contact us at Florida Healthcare Law Firm today.