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Jones Health Law Podcast: Episode 1 – Health Insurance

We have officially released our very first podcast episode! Click HERE to listen or below.

We call this series “PERSPECTIVES” because the goal is to interview individuals who work as practitioners and professionals in the health care industry and ask them to answer focused questions about the health care industry from their perspective. In future episodes we will interview, healthcare executives, healthcare providers as well as healthcare entrepreneurs.

 

 

In this episode we discuss health insurance with licensed health insurance Agent, Oxana “Oxanacare” Parfenova. She discusses the (1) challenges of being a Health Insurance Agent; (2) how and why she got into the industry; (3) distinguishes between Obamacare a/k/a Affordable Care Act and commercial plans; (4) common health insurance acronyms, phrases and words that are important for any subscriber to understand; (5) current and future industry trends; and (6) most importantly who is eligible for health coverage and how, when and where can they obtain that coverage…and at what cost?

Oxana can be reached at:

Instagram: @Oxanacare

Phone: 786-352-5879

Email: OxanaP87@gmail.com

Understanding the Intervention Project for Nurses Monitoring Contract

If you are a nurse (i.e. LPN, RN, APRN, etc) and have decided to participate in the Intervention Project for Nurses (“IPN”) you will first have to undergo an evaluation, which will include an interview with an IPN approved doctor and a toxicology test. After this evaluation has been completed, IPN may suggest no monitoring or require that you enter into a monitoring contract.

Typically, you have roughly two weeks to sign the monitoring contract. Prior to signing the contract, you should thoroughly review the IPN Participant Manual so that you understand the requirements for participation. The last thing you want is to comply with the monitoring contract only to have your contract extended or have your case referred to the Board of Nursing because you failed to adhere to the Participant Manual’s requirements.

You will also receive a contract packet, which will include: (1) Progress Evaluation for Therapy Form; (2) Work Performance Evaluation Form; (3) Notice of Address/Employer Change; (4) IPN Medication Management Evaluation Form and (5) Medication Report. Depending on your situation you many not be required to complete all of these forms.

Requirements

Contract lengths typically vary from 2 – 5 years and you are required to keep your contact information updated throughout the term of the contract. IPN will review your participation after one year of active monitoring. If you comply with the terms of the contract they will grant you early completion and suspend your contract. For example, if you are have a 2 year contract term and you pass all of your toxicology testing and other requirements under the contract IPN may suspend the second year of your contract so that you can return to practice without any further obligations under the contract.

During the contract period you will be required to undergo random toxicology testing. This is an abstinence contract which means that you are prohibited from using mood altering, controlled or addictive substances including alcohol or alcohol-based products or THC/cannabis products (i.e. CBD, Hemp, etc.). This is true even if you are not participating in the IPN program for any of these specific products.

Periodically, you will need to check in with the Affinity eHealth/Spectrum Compliance App for your toxicology testing notification Monday through Friday. Again, to ensure the accuracy of your testing, you must adhere to the recommendations in the Random Toxicology Testing section of your Participation Manual.

You are required to complete and submit a quarterly self-report online via the Spectrum Compliance App. Quarterly reports are due in January, April, July and October. The App will have a complete list of reports due each quarter some of which can be downloaded from the available reports page by clicking on the PDF link.

Employment Expectations

Prior to accepting a position (paid or volunteer) and/or beginning nursing school clinicals, you are required to inform your immediate supervisor you are an IPN participant. Your position must include direct supervision by another licensed healthcare professional who is: (1) aware of your IPN participation; (2) working on the premises or same unit with periodic observation; (3) readily available to provide assistance and intervention; (4) willing to complete required employer report each quarter.

RNs must be supervised by another RN or APRN and LPNs must be supervised by RNs. LPNs may only be supervised by LPNs in nursing home facilities. You must immediately notify and/or obtain approval from IPN prior to starting or making any changes in any health care related position (i.e. resignation/termination, new employment, supervisor change, etc.) You are also required to work in nursing a minimum of twelve (12), eight (8) hour shifts per quarter while employed, to meet completion criteria.

Unless you have special approval from IPN you may not: (1) be self-employed or work for multiple employers; (2) work for more than 40 hours per week and/or more than 84 hours bi-weekly, if not working 12-hour shifts; (3) work for an agency, home hospice, home health, or float outside the areas supervised by your manager.

Current Status

Your Contract will also state your employment status. Depending on the severity of your condition you may be approved for employment in a supervised nursing position. You are required to provide your immediate supervisor with a copy of the Monitoring Contract and provide your supervisor’s email address to IPN for completion of your quarterly reports. You also need to provide IPN with the contact information for your current place of employment as well as the name of your immediate supervisor. If you fail to relay this information to IPN you may face immediate termination from the IPN program.

Review for Early Completing

As stated above, you may have your contract reviewed for early completion. However, it is contingent upon: (1) compliance with all terms of the Monitoring Contract; (2) negative toxicology tests; (3) minimum of six (6) consecutive months of negative toxicology tests preceding the contract completion date; (4) satisfactory work performance in a clinical nursing position for a minimum of one year; (5) if applicable, recommendation for completion form your Support Group Facilitator, employment supervisor, and treatment provider; and (6) if applicable, work successfully for six (6) months in a clinical nursing capacity subsequent to controlled substance restriction being lifted. For Board of Nursing participants, a readiness-to-complete evaluation is mandatory.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Registration form for Autonomous Advanced Practice Registered Nurse is Now Available

Registration form for Autonomous Advanced Practice Registered Nurse is Now Available

Great news for Florida licensed Advanced Practice Nurse Practitioners. The registration application for Autonomous practice is now available. There is no fee associated with submitting the registration application.

Eligibility for registration as an autonomous APRN includes the following:

1. At least 3,000 clinical practice hours under the supervision of an allopathic or osteopathic physician within the past 5 year. These hours may include clinical instructional hours. [See Section 464.0123(1)(c) F.S. for complete requirements];

2. Three graduate-level semester hours, or the equivalent, in differential diagnosis and 3 graduate-level semester hours, or the equivalent, in pharmacology completed within the past 5 years (documentation required); and 

3. Not been subject to disciplinary action as specified in Section 456.072 F.S. or Section 464.018 F.S., or any similar disciplinary action in any state or jurisdiction within the past 5 years.

The Board is also working towards adopting a definition of “primary care practice”. It was the subject of a rules workshop on October 9, 2020.

 

Frequently Asked Questions are at this link – https://floridasnursing.gov/nursing-faqs/advanced-practice-registered-nurse-aprn/

 
 

What is a Professional Limited Liability Company?

By: Marcus Leonard

 

What is a PLLC?

Many people are familiar with limited liability companies (“LLC”) including liability protection and other benefits provided by this type of business structure. Slightly different, a professional limited liability company (“PLLC”) is an LLC formed specifically by those who are licensed to provide professional services.

The term “professional service” means any type of personal service to the public which requires someone to obtain a license or other legal authorization to perform such service. Many medical professionals are authorized to form PLLC’s, including chiropractic physicians, dentists, osteopathic physicians, physicians and surgeons, doctors of medicine, doctors of dentistry, and podiatric physicians.

It is important to note that in Florida, a PLLC is only authorized to engage in providing the professional services for which it was organized. Additionally, all members must be licensed to provide the specific professional services offered by the PLLC and remain subject to the rules and regulations of the relevant state professional licensing authorities. For example, a group who wants to form a PLLC for a dental practice is authorized to engage only in dental services and all members must be licensed dentists. Accordingly, while practicing, the dentist will remain subject to the rules and regulations provided by the Florida Board of Dentistry.

 

PLLC’s Protections

A PLLC, like a standard LLC, offers some personal liability protections but does not shield members from all types of liability. The structure of a PLLC will provide members with protection from creditors attempting to collect unpaid debts owed by the PLLC, liability for the malpractice of other PLLC members, and from malpractice suits and other torts connected with the PLLC. Unfortunately, a PLLC will not protect members from liability if they have personally guaranteed a business loan, engaged in professional malpractice, or were negligent or intentionally committed a tort.

 

How Do You Form a PLLC in Florida?

Compared to other business structures, forming a PLLC is often more straightforward which is a major benefit for those who want to begin practicing as soon as possible. As mentioned above, it is important that all professional members of the company have the necessary state licenses and certifications. Members must then contact the relevant state licensing board to find out what approval is required for their profession. Those who wish to form a PLLC must draft and file articles of organization with the Florida Division of Corporations. This will include a statement of specific purpose, such as the practice of dentistry, medicine, or another professional service.

 

Different from a Professional Corporation

A PLLC is not to be confused with a professional corporation (“PC”).  A PLLC, like other LLCs, is comprised of members. On the other hand, a PC is comprised of shareholders. This distinction is important because PLLC ownership consists of membership interests in the business, while PC ownership is based on shares of stock.

In Florida, authorized licensed professionals can form both PLLCs and PCs. Although a PC has its appeal and provides liability protection, it requires more paperwork and, in some cases, does not benefit from the tax advantages of a PLLC.

 

Conclusion

It is highly recommended to speak with someone who specializes in healthcare when deciding on the best legal entity for your practice. The team at Jones Health Law is eager to assist authorized licensed professionals seeking instruction or guidance with the formation of a Florida PLLC or other business structure.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Medical Director Responsibilities in a Florida Healthcare Clinic

By: Marcus Leonard

The role of medical directors 

Apart from the thousands of screaming fans, the role of a medical director is analogous to the role of the head coach on your favorite sports team as both are undoubtedly invaluable to an organization’s success but are also required to absorb responsibility if expectations are not met. A medical director’s role is so vital because a licensed health care clinic in Florida may not operate or be maintained without the day-to-day supervision of a single medical or clinic director. In Florida, medical or clinic directors are paramount to facilities and clinics maintaining a high quality of care and operating while in compliance with the law.

 

By law, a medical director must be a health care practitioner that holds an active and unencumbered Florida license as a medical physician, osteopathic physician, chiropractic physician, or podiatric physician. It is important to note that a license that is suspended or has not been renewed is considered an encumbered license. The type of services provided at a clinic may dictate who would be able to serve as a clinic’s medical director. A medical director must be authorized under law to supervise all services provided at the clinic, therefore, a clinic that provides general health and wellness services cannot be supervised by a chiropractic or podiatric physician because of limitations to the scope of practice.

 

General responsibilities

Each clinic shall appoint a medical director or clinic director who shall agree in writing to accept legal responsibility for the following activities on behalf of the clinic. The medical director or the clinic director shall:

 

(a) Have signs identifying the medical director or clinic director posted in a conspicuous location within the clinic readily visible to all patients.

 

(b) Ensure that all practitioners providing health care services or supplies to patients maintain a current active and unencumbered Florida license.

 

(c) Review any patient referral contracts or agreements executed by the clinic.

 

(d) Ensure that all health care practitioners at the clinic have active appropriate certification or licensure for the level of care being provided.

 

(e) Serve as the clinic records owner.

 

(f) Ensure compliance with the record keeping, office surgery, and adverse incident reporting requirements. 

 

(g) Conduct systematic reviews of clinic billings to ensure that the billings are not fraudulent or unlawful.

 

This non-exhaustive list works as a general guideline of responsibilities that a medical director would follow to ensure that clinics and facilities are operating efficiently and within the defined legal parameters. Although the medical director’s responsibilities are immense, there are restraints to the role such as the number of clinics one medical director can supervise at any time. Additionally, geographic restrictions and rules governing a medical director’s presence at facilities help regulate medical directors’ duties. 

 

The risk for medical directors and their facilities

The role of a medical director includes several inherent risks including legal risks for professional liability, regulatory compliance, and board complaints. Failure of an appointed medical or clinic director to substantially comply with health care clinic responsibilities shall be grounds for the revocation or suspension of the license and assessment of a fine. In some cases, clinics may not be absolved from liability caused by a medical director. Health care clinics may be found liable for their medical directors’ failure to fulfill their statutory duties. Additionally, the health care clinic’s responsibilities cannot be met without an active, appointed medical or clinic director. Consequently, the law is clear in explaining that a health care clinic without a medical or clinic director is subject to revocation of licensing and the assessment of fines.

 

Conclusion  

As more clinics and health care facilities open, more licensed practitioners will be hoisted into the role of a medical director. This role requires navigation through a complex labyrinth of compliance and legal responsibilities. Whether you are a clinic in search of a new medical director or you are a physician who is considering serving as a one, Jones Health Law can lend a helping hand. Our firm is well equipped with knowledgeable and experienced health law attorneys who can assist you with any questions or concerns regarding the responsibilities and requirements of medical directors.

 

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Does the FDA consider Aromatherapy and Essential Oils a Cosmetic or a Drug?

Essential Oils Product Descriptions: Am I a Cosmetic of a Drug?

Whether an aromatherapy product is a cosmetic or a drug under the law is determined by the product’s intended use. The Federal Food, Drug and Cosmetic Act defines “cosmetics” by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Florida Statute §499.003(12) adopted the FDA’s definition of “cosmetic” verbatim, but further stated that the definition does not include soap. The law doesn’t require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if they have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly.

The FDA Act defines “drugs”, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims.

Intended use may be established by claims stated on the product labeling, what consumers expect it to do, in advertising on the internet, or in other promotional materials. Ultimately, the FDA makes decisions on a case-by-case basis. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. It may also be established that a product is a drug based upon the ingredients that have a well-known therapeutic use.

Essential oil fragrances marketed for promoting attractiveness is a cosmetic. However, a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Under Florida Statute §499.005(5) it is a crime to disseminate false or misleading advertisement of a drug, device or cosmetic, which is punishable as a misdemeanor of the second degree. It is also a violation of the Florida Drug and Cosmetic Act to disseminate any false advertisement of any drug, device or cosmetic, which includes misleading advertisements according to Florida Statute §499.0054(1)(a). These advertisements include those on a website or social media account. Keep in mind that a cosmetic product must be labeled according to cosmetic labeling regulations.

It’s important to note that the FDA regulates labeling for cosmetics and drugs but advertising claims are regulated by the Federal Trade Commission. No cosmetic such as essential oils may be labeled or advertised with statements suggesting that FDA has approved the product. Under Florida Statute §499.003(2), “advertisement” is defined as any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.

In 2014, the FDA sent a warning letter to an essential oils company called Young Living and stated that some of their products that were marketed on their websites and social media accounts were promoted to treat conditions which caused them to be viewed as drugs. These products included “Cinnamon Bark,” “Oregano,” “Rosemary,” “Sandalwood,” “Peppermint,” “Frankincense” and others. The FDA argues that these are “new drugs” because they are not generally recognized as safe and effective for the intended use under the conditions prescribed, recommended or suggested in the labeling in the Young Living case. If you intend to market and describe these products as some type of treatment or disease prevention then you would need to seek FDA approval first. Further if used for those purposes, they would have to be provided under the supervision of a practitioner licensed by law to administer it. If you don’t make any medical claims in your advertisements you likely won’t trigger any action by the FDA or FTC.

Also, in 2014, the FDA sent a warning letter to another essential oils company called DoTerra for marketing its products that they claimed would treat, diagnose, cure, mitigate and prevent medical conditions.

You should avoid using language such as, “It has some crucial medical benefits as well” and “relieving medicine”  in the product details for your products.  Refrain from making claims that these products will  reduce stress-related headaches, reduce or eliminate acne problems, help with sleep, cure food poisoning.

Also, I would suggest that you include a Disclaimer for both product details and any blog posts. You should include in the disclaimer that says something like “The information in this post about essential oils is not intended to diagnose, cure, mitigate, treat or prevent any disease. According to the FDA, only drugs can make those types of claims, which these products on our website are not.”

Typically, any products marketed as “antibacterial,” “antiseptic,” “antiviral,” “anti-inflammatory,” “ant-cancer,” or “antimicrobial” are drugs according to the FDA. If a product is intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, they’re drugs. Avoid using these words in descriptions or blog posts or else you risk receiving a warning letter from the FDA.

You should avoid making claims like “Essential oils are the natural remedies for curing damaged skin and tightening loose skin” or that “essential oil has tremendous health benefits” . This implies some type of medical benefit and you do not want to make those types of claims. Simply avoid making any medical treatment, diagnosis or preventative claims. This is true even if these are not included in product  descriptions but in blog posts on your website or social media posts. Making research claims that any individual product may treat  ailments or diseases on your blog or social media may also  result in a warning letter issue to you from the FDA. Instead of using words like “treat” you should try using “rejuvenate,” “revitalize” or “reinvigorate” because those aren’t really medical terms.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

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