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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.

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.

Can I Continue to Run a Medical Practice After the Sole Physician’s Death?

Authored by Marcus Leonard and Jamaal R. Jones, Esq.

Authored by Marcus Leonard and Jamaal R. Jones, Esq.

Inevitably, we will all pass away at some point in hopefully the distant future. Some of our deaths will be expected while others will come as a complete shock. Many people formulate a plan for after their passing and make arrangements accordingly for the succession of their personal and business affairs and belongings, while others do not. Occasionally, that deceased person happens to be the only physician in the medical practice. The staff and surviving family members have to quickly determine what their options are and whether they can legally continue to operate the practice without the physician.

Florida does not have the same Corporate Practice of Medicine Prohibitions as other states. In short, this means that you do not have to be a licensed medical doctor or doctor of osteopathy to own a medical practice. Many people erroneously believe that because of this fact they can continue to run the physician’s practice without taking any further action after she passes away. The Florida Health Care Clinic Act (the “Act”) requires that all health care clinics operating in Florida maintain a valid license by the State unless they fall within a statutory exemption. Also, if the health care clinic is cash-pay only and not accepting reimbursement from a commercial payor, Medicare or Medicaid then Florida law allows the business to continue to run without first obtaining the license. According to the Act, a “clinic” is defined as an entity which provides health care services to patients and bills third party payers for reimbursement for providing those health care services. Clinics that are “wholly owned by one or more licensed health care practitioners” are exempt from obtaining a health care clinic license. Thus, if a clinic is owned by a licensed health care practitioner who is supervising the services performed at the clinic and who is legally responsible for the entity’s compliance with all federal and state laws, the clinic falls within one of the exceptions and is exempt from the Act’s licensure requirements. However, in the untimely event that a sole physician/owner passes away, the clinic is no longer afforded exemption from the Act’s licensing requirements and is no longer in compliance with the law.

 

What are my Options?

In this instance, the family members have the following choices: (1) close the practice; (2) sell the practice; or (3) apply for a health care clinic license. If the decision is made to close the practice then you have to make sure that you wind up and dissolve the business accordingly. Alternatively, it can be tricky if the decision is made to sell the practice. Even if you hire another physician to provide treatment to the patients while you try to find a buyer for the practice you will still be violating the Act. As a result, you must not continue to provide health care services until the practice is sold to someone or an entity that qualifies for an exemption under the Act or until you receive a health care clinic license.

This is important because Florida law provides that an insurer is not required to pay for medical treatment that is not lawfully provided. The plain language of the Act makes clear that a claim for reimbursement made by a clinic that is not properly licensed or that is otherwise operating in violation of the Act, constitutes an unlawful charge that is deemed non-compensable and unenforceable.

Filing the application with the Agency for Health Care Administration for a health care clinic license it tedious and must be done carefully or you risk denial. Also, the applicant should not expect to receive the license expeditiously.

 

Penalties

Under the Act, it is considered theft for an entity that does not have a health care clinic license and does not meet the requirements for an exemption to submit a charge for reimbursement. You can be charged with committing a third-degree felony if you operate an unlicensed clinic. Each day that the person violates the act is considered a separate offense. If a physician who is working for a clinic knows or has reasonable cause that the clinic is operating without a license and fails to report the clinic then that physician will be reported to the medical board for failure to report the clinic. There will also be administrative penalties imposed upon those who practice without a license.

 

Conclusion

A clinic is required to register for a license under the Act even if they were previously exempt from licensure requirements prior to the physician’s death unless some other applicable exemption exists. A sole health care provider should create a plan for succession in the event of their death. For example, upon the physician’s death the shares of the practice can “automatically” transfer to another physician of their choosing so that there isn’t a gap in care to patients. This would require careful planning and legal considerations beforehand. Our firm is well equipped with knowledgeable and experienced health law attorneys who can assist you with planning for this difficult event.

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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.

How Does a Nurse Practitioner Establish an Independent Practice in Florida?

Effective July 1, 2020, Advanced Practice Registered Nurses (“APRN”) will be able to register their own autonomous practice throughout Florida with the passage of House Bill 607. No longer will the APRN have to provide patient care within the framework of an established protocol with a supervising physician if they are properly registered. If the APRN is not registered then an established protocol will still be required. The term Health Care Provider has been re-defined to mean a physician, osteopathic physician, podiatric physician or an APRN registered under Florida Statute §464.0123.

 

Registering your Autonomous Practice

Autonomous Practice is defined as an advanced nursing practice by an advanced practice registered nurse who is registered under Florida Statute §464.0123 and who is not subject to supervision by a physician or a supervisory protocol. In order to be registered by the Board of Nursing as an autonomous practice the APRN has to demonstrate the following:

  1. Hold an active and unencumbered license to practice advanced nursing.
  2. Not be subject to any disciplinary action in Florida or any other state or territory within the 5 years immediately preceding the registration filing.
  3. Completed in any state, territory or jurisdiction of the United States, at least 3,000 clinical practice hours within the 5 years immediately preceding the registration request while practicing as an APRN under the supervision of an M.D. or D.O.
  4. Completed within the past 5 years 3 graduate-level semester hours, or the equivalent, in differential diagnosis and 3 graduate-level semester hours or the equivalent, in pharmacology.
  5. And any other additional registration requirements issued by the Board of Nursing.

 

After obtaining your registration certificate, an APRN must biennially renew the registration, which must coincide with the APRNs biennial renewal period for licensure. To renew the registration, an APRN must complete at least 10 hours of continuing education, in addition to completing 30 hours of usual continuing education requirements.

 

Financial Responsibility

An APRN registered to maintain an autonomous practice must demonstrate that they are financially responsible to pay claims and costs that may arise out of their rendering of care, treatment or services. An APRN can demonstrate this in one of two ways:

  1. Obtain and maintain professional liability coverage in an amount not less than $100,000 per claim, with a minimum annual aggregate of not less than $300,000.
  1. Obtain and maintain an unexpired, irrevocable letter of credit in an amount of not less than $100,000 per claim, with a minimum aggregate availability of credit of not less than $300,000, payable to the APRN.

 

These financial responsibility requirements do not apply to: (1) registered APRNs who practice exclusively for the Federal Government or the state; (2) APRNs who are inactive; (3) APRNs practicing only in teaching environments at an accredited school or teaching hospital; and (4) an APRN who is registered but is not engaged in autonomous practice.

 

Registered APRN Permitted Activities

A registered APRN may only establish an autonomous practice in primary care, including family medicine, general pediatrics, and general internal medicine. APRNs certified as nurse midwives may engage in the practice of midwifery in accordance with Florida Statute §464.012(4)(c). APRNs engaging in autonomous practice must provide information in writing to a new patient about his or her qualifications and the nature of the autonomous practice before or during the initial patient encounter.

A registered APRN may also (1) admit a patient to a health care facility; (2) manage the care that the patient receives at the facility: and (3) discharge the patient from the facility, unless prohibited by federal law. The ARPN may provide a signature, certification, stamp, etc., that is otherwise required by law to be provided by a physician so long as the APRN is not issuing a physician certification.

 

Adverse Incidents and Disciplinary Actions

Registered APRNs must report adverse incidents to the Department of Health in writing within 15 days after the occurrence of the adverse incident if the adverse incident occurred when the patient was in the direct care of the APRN. If not in the direct care of the APRN, the report must be postmarked within 15 days after the APRN discovered or reasonably should have discovered the occurrence of the adverse incident. An adverse incident occurs when a patient: (a) is transferred from the APRN practice location to a hospital; (b) suffers permanent physical injury; and/or (c) dies.

A registered APRN may be subject to disciplinary action if he or she:

  1. Pays or receives a kickback or any type of split-fee arrangement for referring patients to providers for healthcare goods or services.
  2. Uses their influence to engage a patient in sexual activity.
  3. Makes deceptive, untrue or fraudulent representations.
  4. Solicits patients by use of fraud, intimidation or undue influence.
  5. Fails to maintain legible medical records
  6. Uses their influence to exploit the patient for financial gain.
  7. Performs unauthorized professional services.
  8. Performs experimental therapies or procedures without first obtaining fill informed consent.
  9. Delegates professional responsibilities to a person that is not qualified by training to perform those activities.
  10. Acts in a manner that coerces or intimidates another APRN from advertising his or her services.
  11. Advertises that they have a certification that he or she has not received.
  12. Fails to inform patients about their rights and how to file a complaint.
  13. Provides deceptive or fraudulent expert witness testimony.

 

Conclusion

There are many other requirements that an APRN has to comply with in order to legally establish and operate their autonomous practice in Florida. As more APRNs register I’m confident that additional laws and/or rules will be created to further regulate the practice area. It is important to hire a health law attorney who has the requisite experience, knowledge and training required to help you navigate the laws.

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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.

Criminal Liability for Rationing Medical Equipment During the Coronavirus Pandemic

Recently, a physician client called me and she was very concerned about potentially being charged with murder for rationing medical equipment, such as ventilators, during the COVID-19 Pandemic. She had been instructed by superiors to use the ventilators, which were in scarce supply, only on those patients that had the best chance of recovery. For the others, she would effectively be sentencing them to death and this caused added stress to an already stressful situation. I took the time to alleviate her concerns about potential liability and thought that I would share it with you as well.

 

  1. Can I Be Convicted of Murder for Rationing Medical Equipment?

 

In Florida, Excusable Homicide is defined as “the killing of a human is excusable, and therefore lawful when the killing is committed by accident and misfortune in doing any lawful act by lawful means with usual ordinary caution and without any unlawful intent.” I am not a criminal law attorney, but I believe that a physician could use Excusable Homicide as a defense in the very unlikely event that he finds himself in a position where murder charges were brought against him in connection with the death of a patient who didn’t receive certain medical treatment due to equipment rationing.

Florida has 3 different degrees of murder but I will only discuss the most serious, first-degree murder. First degree murder is defined as any intentional murder that is willful and premeditated. For a first-degree murder conviction, premeditation and deliberation must be proven. This doesn’t mean that a specific period of time must be involved in the planning of the murder. A prosecutor would only have to show that the perpetrator had enough time to consciously form a plan to commit the act with the intent to kill while also having enough time for a reasonable person to stop themselves from committing the act. It is not the intent of a healthcare provider to kill a patient when they ration medical equipment or supplies. They have limited resources and are making the best use of those resources given the circumstances. Absent any evidence to the contrary, I believe that any deliberation by the provider would be about prolonging human life and not willfully ending it. This is why I’m confident that no healthcare providers will be charged or convicted of first-degree murder, or any of the lesser degrees, for rationing of medical equipment during this pandemic.

  1. Can I Refuse to Provide Emergency Treatment to a Patient During the Pandemic?

 

The most obvious situation when a physician can refuse treatment is if the physician does not treat patients with the patient’s specific condition. In 1986, President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (“EMTALA”) into law. The legislative intent of the law was very straightforward. A hospital with an emergency department could not turn away patients needing care because of their inability to pay. Hospitals are also prohibited from “dumping” patients onto other facilities for reasons other than receiving advanced treatment. Under EMTALA, if a patient presents herself to an ED with an emergency condition the ED is required to stabilize and treat the patient, regardless of her ability to pay. It’s important to note that a hospital may correctly follow EMTALA guidelines but still be responsible for malpractice damages if they misdiagnose a patient.

There may be situations where a hospital and its physicians do not have the capability to fully stabilize and treat a patient. In those situations, EMTALA allows a hospital to transfer the patient to get the appropriate level of care. For example, if a hospital is short on ventilators due to the Coronavirus that hospital may transfer the patient to another hospital that has an available ventilator so long as the patient is stable enough to physically handle the transfer and they’ve received informed consent.

Under EMTALA, a patient cannot directly sue a physician or hospital for not complying with EMTALA’s requirements, but physicians may be subject to civil monetary penalties and may be subject to exclusion from participation in the Medicare and Medicaid programs for repeated violations of EMTALA.

  1. Prohibited Activities and Liability during the Coronavirus Pandemic

 

Under Florida Statute §458.3295(1), which is titled “Concerted effort to refuse emergency room treatment to patients; penalties”, A Florida licensed physician may not instigate or engage in a concerted effort to refuse or get physicians to refuse to render services to a patient or patients in a hospital emergency room by failing to report for duty, absenting themselves from their positions, submitting their resignations, abstaining from the full and faithful performance of their medical duties, or otherwise causing conduct that adversely affects the services of the hospital. For the purposes of this subsection, the term “concerted” means contrived or arranged by agreement, planned or devised together, or done or performed together in cooperation.

Under Florida Statute §395.1041, Neither the hospital nor its employees, nor any physician, dentist, or podiatric physician are liable if a refusal to render emergency services or care is made after screening, examining, and evaluating the patient, and is based on the determination, exercising reasonable care, that the person is not suffering from an emergency medical condition or a determination, exercising reasonable care, that the hospital does not have the service capability or is at service capacity to render those services. If a hospital does not have capacity, the necessary medical equipment or supplies to treat a patient due to the Coronavirus pandemic, the hospital and its providers cannot be held liable for refusing to render certain emergency services or care.

  1. Final Thoughts

 

Presently, we are dealing with an extremely unusual set of circumstances and difficult decisions have to be made. The reality is that we have to ration the ventilators. We have over 350 million people in this country and estimates are that 40-60% of the population have or will contract COVID-19. Italy, Spain, France and China have had to ration their ventilators. Even healthcare providers are becoming sick and are using the ventilators.

The federal government, so far at least, is not providing national rationing guidelines for the coronavirus outbreak other than those issued by the CDC, HHS and VA. The Centers for Disease Control and Prevention has laid out general principles for how to allocate scarce resources in a pandemic response plan, but it leaves most of the details to individual states and institutions. States are coming up with their own ethical principles to determine need, while others are prioritizing patients based on their health condition, preexisting health problems and age. Countries around the world are doing the same thing. It’s not a first-come first-serve model right now. Hospitals are transferring patients to less crowded hospital or healthcare facilities, sanitizing and reusing supplies, coming up with makeshift ventilators, cancelling elective surgeries and procedures etc. Anything they can do to treat patients. To avoid conflicts of interest and the emotional toll of life-or-death judgments, many state plans call for a senior, supervisory doctor or a panel of doctors — similar to a “three wise men” protocol developed in Britain for this scenario — who are not the provider directly caring for the patient.

The Coronavirus Pandemic has been compared to a war and our doctors and nurses are the front line of defense. They’re our soldiers in this battle. They are basically operating under combat medicine guidelines, which means that they have to triage patients and prioritize care in a discriminate way based upon their chances of recovery but not discriminatorily. I can’t imagine a scenario where a prosecutor would bring charges against a physician for making the difficult decisions that they had to make during this pandemic. Even if they do, I doubt that a jury of their peers would find them guilty of murder given the circumstances. When this pandemic is behind us, I don’t believe that any healthcare providers will be charged or convicted of murder for rationing any medical equipment or supplies.

 

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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.

Buyer Beware: Successor Liability Issues When Purchasing a Physician Practice

If you’re purchasing a physician practice or any other type of Florida healthcare entity you must ensure that you have structured the acquisition in such a way that you are not inheriting the liabilities of the previous owner. To do so, you must conduct a thorough due diligence process and draft the appropriate agreements.

In Florida, a purchaser is generally not liable for the debts and liabilities of the seller unless the purchaser expressly (or impliedly) agrees to assume such debts and liabilities. Successor liability has the potential to become an issue when you purchase any existing company. The purchaser has the option to limit the assumption of liabilities of the seller by structuring the acquisition in a specific way. By doing so, the purchaser won’t be responsible for paying the seller’s debts and liabilities. Typically, in a “stock” purchase you are responsible for all liabilities and debts of the company, while in an “asset” purchase you are only assuming those liabilities and debts that you specifically agree to assume.

 

Stock vs. Asset Purchase

  1. Stock In a stock purchase you are acquiring the stock of the seller’s company. The essence of the acquired company does not change other than the fact that it has a new owner. All of the assets (unless otherwise stated) as well as its debts and liabilities stay the new owner, whether they’re known or unknown at the time of the sale. This is what is called “stepping into the shoes” of the previous owner.

 

  1. AssetIn an asset purchase you create a business entity (i.e. an LLC or Corporation) to purchase specific assets and liabilities of the seller’s company. These are called “Acquired Assets”. This is different from a stock purchase where you are buying the entire company and not just pieces of the company. The seller’s company may remain in place after the asset purchase and they can continue to run it independently absent the assets and liabilities that they have sold to the purchaser. Alternatively, the seller may choose to close their business or sell other assets of the company to another purchaser or both.

 

Automatic Assumption of Liability Even in an Asset Purchase

Most healthcare entity acquisitions are structured as asset purchases to avoid the assumption of the all liabilities. However, there are instances where a purchaser still assumes certain liabilities by operation of law even when it is an asset purchase.

  1. Doctrine of Successor LiabilityA purchaser assumes liabilities if the acquisition was done to purposely undermine the business interests of creditors. A purchaser strips the entity of its most valued assets and transfers them to another entity for a nominal purchase price so that when the creditor sues the defaulting original company there are no valuable assets for them to force the sale of to recoup their losses.

 

  1. TaxesIf one of more of the assets that you are acquiring through an asset purchase has a pre-existing tax lien or UCC filing, your asset purchase agreement will not automatically extinguish those obligations. Those obligations will be paramount to your purchase and will have to be dealt with accordingly.

 

Exceptions to the Purchase Agreement

  1. De Facto Merger ExceptionThis exception will be triggered if you answer “yes” to any three or more of the following questions: (1) Is there a continuation of the enterprise? (2) Is there a continuity of shareholders? (3) Has the selling company ceased its ordinary business operations? (4) Has the purchasing company assumed the seller’s obligations?

 

  • Continuation of the enterprise– Exists when the physical location, directors, officers, assets, management, employees, etc. are the same (or substantially similar) between both the seller and purchaser.

 

  • Continuity of shareholders– Exists when the same (or substantially similar) shareholders/owners exist in both the companies.

 

  • Cessation of operations– Exists when the seller ceases to conduct its business after the sale of the assets.

 

  • Assumption of obligations– If the purchase agreement doesn’t clearly stipulate which obligations will be assumed by the purchaser (i.e. vendor agreements, leases, etc.) the purchaser may become liable for the seller’s obligations.

 

  1. Mere Continuation ExceptionIs triggered if only one company exists after the transfer of assets and the same stockholders and directors are present in both companies.

 

  1. Fraudulent Transaction ExceptionThis occurs when the owners of the purchasing company are transferred to the seller’s owners as payment for the assets. This is an attempt to escape certain debts and obligations of the seller company.

 

Conclusion

It is critically important that you hire an experienced business law attorney who has drafted these agreements specifically for healthcare entities. This attorney must conduct a thorough due diligence process which includes a lien and title search, review of recorded business loans and determine whether there are any outstanding state sales and gross receipt taxes.

 

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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.