MedSpa Business Can Be Quicksand for Physicians

by admin on April 29, 2022 No comments

Many physicians have come to realize the synergy and profitability of establishing a medspa business for their patients.  Done right, it can be the perfect compliment.  And being “off insurance” is a nice pivot for many physicians, especially those in the cosmetic space (or even many OB/GYNs).  While most physicians starting a medspa already understand about the scope of practice and physician supervision issues for mid-level practitioners, most don’t seriously consider the issue of structure.   In short, care has to be taken when structing these businesses. 

Focus needs to be paid to the Florida Patient Self-Referral Act of 1992, which contains a number of “Stark-like” provisions, including those that impact the ability of a practicing physician to own and refer to the business.  Many physicians may think (wrongly) that cash based businesses aren’t impacted by the PSRA or the Patient Brokering Act (PBA).  Wrong! There is no such demarcation in those laws. 

If the physician is retired or not practicing medicine, the structure issues are mitigated.  But for physicians in practice who own a med spa, they need to understand the PSRA provisions that speak to ownership interest limitations and also to ownership interest disclosure requirements.  While these issues are not insurmountable (and not nearly so daunting as supervising physician qualifications), they are not mere details.  They’re important ones!

Medspa owners often think that the usual (and harsh) healthcare laws, like the Anti-Kickback Statute (AKS), the safe harbors and the Florida Patient Brokering Act (and other state based laws like those related to fee splitting) don’t apply to cash based med spas.  That’s flat out wrong!  There is no such cash v. insurance delineation with these laws.  And while it’s true that the AKS applies only when state or federal healthcare program monies are at play, it’s also true that he PBA requires safe harbor compliance, thus expanding the AKS and safe harbor reach well beyond state and federal healthcare program based businesses. 

Where will medspas see these laws most likely coming to bear?  In healthcare professional and marketing compensation arrangements.  This is where issues like percentage based compensation arrangements, for instance, are specially tricky.  Medspa owners must be tutored on the meaning and application of all the laws mentioned above.  And since the navigation and application of those laws necessarily requires (1) education about the laws, (2) exploration of the options, and (3) a risk assessment for each such option, it’s easy to understand why one size fits none!  If anyone is selling the one size option, run!  They’re (unknowingly) walking right into quick sand.    

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Florida Statute of Limitations for Medical Malpractice

by admin on April 28, 2022 No comments

Medical malpractice statutes and limitations are not straightforward. This ambiguity can serve to protect both the patient and the medical professionals who are doing their best to help their patients with the knowledge and resources that are accessible.

The clock starts ticking at the time medical care is provided, but another clock starts ticking on the day the patient realizes there are problems that could indicate malpractice.

However, in the event that a provider actively covers up the malpractice and deceives the patient, all clocks stop.

Here’s what you need to know.

What Is the Florida Medical Malpractice Statute of Limitations?

When a person receives medical care, the general rule is that they have two years from that date to file a malpractice claim in Florida.

This two-year limitation is extended to four years in certain circumstances. For example, if the person doesn’t realize they have suffered harm as a result of the medical care for up to four years after the medical care, this timeline is extended. This delayed realization would have to be proven in court in addition to the need to prove that malpractice occurred.

If the person doesn’t realize they were harmed due to a medical provider’s care until four years and one day or beyond, any attempt to file a malpractice case will be thrown out unless they can show that the doctor or medical facility actively covered up the malpractice or deceived the patient. This will also need to be proven in addition to the original malpractice claim and the facts supporting the delayed realization of harm.

It is important to note that a patient must file a Notice of Intent before filing a malpractice case. This will detail the nature of that case and give the person or business 90 days to respond. This filing stops the clock on the statute of limitations.

In many cases, a settlement offer may be provided within that 90-day period, but if the professional or business indicates that they will not settle, the patient must file a malpractice suit within the remaining time left in the 90 days after notice or the amount remaining in the statute of limitations, whichever provides them with more time.

What Are Florida Medical Malpractice Caps?

There are also some caps in place when it comes to how much a patient may ask for and be granted in a malpractice case. When it comes to non-economic damages, like “pain and suffering,” the cap is set at $500,000. If the damages are economic in nature (such as lost income due to malpractice), the cap is set at $1,000,000.

Florida Statute of Limitations for Medical Malpractice: Get Help

Medical malpractice cases can be complicated. If a settlement is desired, legal counsel can help to ensure a fair and protected deal. Contact Florida Healthcare Law Firm now to discuss the terms of any medical malpractice claims and get help moving forward.

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How to File a Complaint Against a Doctor in Florida

by admin on April 20, 2022 No comments

The Florida Department of Health is the regulatory agency responsible for protecting the public in the world of healthcare.

They require medical professionals of all kinds to attain a certain level of education in order to gain license to practice in the state. They further require medical professionals to maintain that licensure through ongoing education and a stellar record of patient care.

When one or both of these requirements are threatened, the professional may risk fines, imprisonment, loss of licensure, or a combination of these. This applies to professionals in every aspect of healthcare, from physicians and dentists to their support staff.

When a patient feels their doctor has violated their code of ethics or responsibility, they are encouraged to file a complaint with the state. The FDH will investigate these complaints and determine whether or not action is warranted. The process can be lengthy and tedious, and in some cases, legal counsel may be recommended.

How to File a Complaint Against a Doctor in Florida

In the state of Florida, patients, colleagues, and employees can easily file a complaint against an individual practitioner, a business, or both.

This process begins online, but depending on the nature of your complaint, you may be directed to the Florida Department of Health, Agency for Health Care Administration, the U.S. Department of Health and Human Services, Statewide Medicaid Managed Care, Florida Department of Agriculture and Consumer Services, or another agency to continue to process your complaint.

Where and how you file will depend on the focus of your complaint. For example, if you believe that your doctor is fraudulently charging or overcharging you for services, you may need to go to the Department of Agriculture and Consumer Services.

If you would like to file a complaint based on a HIPAA violation, you will have to file with the U.S. Department of Health and Human Services.

Each of these agencies has a different set of forms and procedures to follow as you go through the process.

Florida Medical Board Complaints

If you wish to file a complaint of malpractice with the Florida Medical Board, the process is especially tricky. They make it very clear that while they will investigate the matter and potentially levy fines or pull licensure, they will not represent any patients in civil matters.

Additionally, the process of filing is complex, and it is not always easy to know what should happen next or what is required of the complainant.

Florida Healthcare Law Firm Can Answer Your Questions

If you’ve had a complaint filed against you, the best thing to do is hire an attorney who can assist you. Choose a law firm that has experience with healthcare law specifically as these cases can get complex.

If you have questions related to healthcare law in Florida, contact Florida Healthcare Law Firm today for assistance.

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Pharmacy Fraud: Data Tells the Story

by admin on April 18, 2022 No comments

Today’s Topic:  Did you know the DOJ never tires of chasing the bad guys?

If a pharmacy is going to engage in nefarious activities, it should expect to get caught. Fraud in these cases is generally easy to prove. Simply verifying inventory, orders and dispensing records yields incredible data that when combined with comparative data from peer pharmacies can be used by law enforcement to establish that fraud has been committed.

Latest Enforcement Activity

On April 13, 2022, the U.S. Department of Justice (DOJ) announced a 78-month prison sentence imposed against a 37-year-old owner/operator of several pharmacies in New York, Aleah Mohammed (Mohammed). The sentence was as a result of guilty plea entered by Mohammed in April 2021 for charges of mail fraud, health care fraud and conspiracy to commit health care fraud. As part of her guilty plea, Mohammed agreed to forfeit $5.1 million and pay $6.5 in restitution.

During the course of her criminal conduct, Mohammed engaged in multiple schemes to defraud health care programs, including obtaining more than $6.5 million from Medicare Part D Plans and Medicaid drug plans. Over a five-year period, Mohammed submitted fraudulent claims to Medicare and Medicaid for prescription drugs that were:

  • not dispensed;
  • not prescribed as claimed;
  • not medically necessary;
  • dispensed during a time when one or more of the pharmacies she operated was no longer registered with the State of New York; and
  • often for expensive prescription drugs to treat HIV.

Adding to the mounting evidence against her, Mohammed led a lavish lifestyle and purchased luxury items such a Porsche and jewelry.

Lessons Learned

It seems that criminals never learn. They think that they are smarter than law enforcement and will never get caught. But rarely do those criminals win in the end. It is basic accounting and law enforcement knows how to do that. Law enforcement mines each pharmacy’s data and looks for outlier information as compared to peer pharmacies as well as inventory data. So what information did the DOJ have at its disposal in this case?

  1. On hand inventory. As with any payer audit, the payer (and law enforcement) can obtain information concerning inventory on hand. If the pharmacy never had the inventory, it could not sell the drug.
  2. Drug purchasing records. Again, unless a pharmacy had the drug in inventory or purchased the drug through one of its wholesalers, it is hard for the pharmacy to defend against fraud charges when it is filing a claim for drugs never in its inventory.
  3. Dispensing records. Dispensing records also reveal information essential to determining what was in inventory, what was purchased and what was dispensed.
  4. Comparative data concerning dispensing of high-cost drugs as a proportion of other drugs sold.
  5. Comparative data looking at peer pharmacies for dispensing trends.

Collectively, the data and these records make it easy for law enforcement to identify and prosecute fraudulent claims. Even so, criminals seemingly are undeterred, and schemes like this one are repeated time and again.

Closing Thoughts

Simply put, crime does not pay. It does not matter whether it is in the pharmacy industry or elsewhere, when government funds are involved, law enforcement will surely be looking for wrongdoers. This probably is not the last case of its kind this year, so expect to see more news of pharmacies/pharmacists behaving badly.

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EKRA Compliance

by admin on April 10, 2022 No comments

The Eliminating Kickbacks in Recovery Act of 2018, or EKRA Law, was enacted by Congress as a part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the Support Act.

The EKRA law makes up Section 1822 of the Support Act. It was designed to put a stop to the practice of accepting kickbacks for referring patients for treatment to inpatient rehab, outpatient treatment, and/or sober houses or recovery homes.

While EKRA targeted the addiction recovery industry, it is applicable across healthcare industries regardless of specialty. It further bolstered already existing laws prohibiting healthcare professionals from getting kickbacks for referring patients to government-funded or private healthcare options.

The price for violating this law and getting caught is steep. Currently, the penalty may include up to $200,000 in fines, up to 10 years in prison, or a combination of both.

EKRA Law: What Is It?

EKRA regulations provide for the protection of patients. It is no longer legally possible for a medical doctor to prescribe OxyContin to a patient and then make money for referring that patient to treatment when they developed an addiction within a year of regular use.

In Florida, this was an especially important law. By 2017, the opioid epidemic had reached such a crisis that then-Governor Scott declared a statewide public health emergency as a result. He addressed the fact that Floridians were suffering and that, in many cases, people with addictions were coming from out of state to take advantage of easy access to opioid painkillers through what were often called “pill mills.”

It was rarely this straightforward of a process and may not have always had malicious intent behind it when it did occur. Still, EKRA put a halt to the practice of giving remuneration of any kind in exchange for a referral for a new patient, not just in the addiction treatment world, but also among dentists, clinical labs, primary care physicians, and medical specialists of all kinds.

Is the EKRA Lab Law Different From the EKRA Law?

No, but the term EKRA lab law often specifically points to the impact of the EKRA law on clinical laboratories. The law defines “laboratory” as any facility that provides “biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body.”

This means, for example, that if any lab that is providing copious blood tests, urine tests, or tests of any kind to a healthcare facility in which it may be deemed as fraudulent for the purposes of billing insurance, or any facility engaged in this behavior, they can be charged under the EKRA Lab Law.

How to Maintain EKRA Compliance

Maintaining EKRA compliance is relatively straightforward. Florida Healthcare Law Firm can help to ensure that your organization, clinic, or lab is staying well within bounds. Contact us today for a consultation.

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Does HIPAA Apply to Minors?

by admin on April 2, 2022 No comments

The Health Insurance Portability and Accountability Act, commonly known as HIPAA, is a federal law that was enacted in 1996 to protect the privacy of patients pertaining to their medical records.

No one can go into a doctor’s office or medical facility of any kind and request to see the medical files of a patient. In fact, healthcare professionals cannot even confirm whether or not a person is getting treatment of any kind at their facility.

But does this law apply to minors who are under the care and guardianship of their parents or law-appointed caregivers? The answer is not straightforward.

Do HIPAA Laws Apply to Minors?

Yes and no. Extended family, teachers, friends, neighbors, or strangers cannot go into a healthcare facility and access the medical records of a child. Additionally, those records cannot be shared between medical offices.

For example, if a pediatrician refers a child to a specialist, that specialist does not automatically have the right to access the child’s medical records without the express consent of the child’s parent or guardian.

However, when it comes to stopping parents or guardians from viewing the medical records of their children, that is where HIPAA does not protect privacy, except in a few select cases.

What Are the HIPAA Laws Regarding Minors?

When it comes to minors, biological parents who have not lost their parental rights in a court of law can legally access their child’s medical records, with or without their child’s consent, except when:

  • The minor requests or consents to a treatment that does not require the consent of a parent.
  • The minor is getting healthcare in order to fulfill a court order.
  • The parent agrees that the medical records can remain private and that the relationship between the child and healthcare provider may be confidential.

Even in these cases, depending on the specifics of the situation and Florida state law on that particular issue, if a parent contests the issue and wants to see their child’s medical files, it is rare that a Florida court of law will allow them to be blocked from access.

Are There HIPAA Laws Specific to Pregnant Minors?

In many cases, HIPAA protects the right of pregnant minors and minors who are parents from the requirement to get parental consent for certain medical care such as contraceptives, treatment for sexually transmitted diseases, and abortion. However, their medical records containing information about these services may not necessarily be protected from parental access.

HIPAA Laws & Minors: Florida Healthcare Law Firm Can Help

If your practice is seeking support in ensuring you are compliant under HIPAA when it comes to the medical records and medical care of a minor, Florida Healthcare Law Firm can help. Call now to set up a consultation.

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Compounded Bioidentical Hormone Replacement Therapy (cBHRT) in Jeopardy of Being Added to the FDA’s “Difficult to Compound List”

by admin on March 22, 2022 No comments

Currently, cBHRT is not on FDA’s list of difficult to compound products, falling under certain exemptions of the FD&C Act, particularly, Sections 503A and 503B. Under Section 503A, a human drug compounded for an identified individual patient based on a prescription qualifies for exemption from three sections of the FD&C Act: 1) current good manufacturing practice for drugs; 2) labeling of drugs with adequate directions for use; and 3) approval of human drug products under new drug applications or abbreviated new drug applications. One of the criteria for these exemptions is that the Secretary has not identified the drug, by regulation, as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. However, before the Secretary may promulgate regulations to add a drug to the difficult to compound list, it must convene and consult an advisory committee on compounding of such drug(s), unless the Secretary finds that issuance of such regulations before consultation is necessary to protect the public.

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What Is an Apology Law in Medical Malpractice?

by admin on March 21, 2022 No comments

Saying “I’m sorry” to a patient shouldn’t hurt your career.

This, essentially, is the primary directive of apology laws or statutes across the country: to stop a patient from using an apology from a medical provider against them in a court of law as grounds for a malpractice suit.

The idea is to grow a more honest and open conversation between patient and doctor, and to ensure that the patient has all the information possible about their medical care.

In some states, Florida included, the law is taken a step farther, requiring medical care professionals to not only inform their patients of all incidents that resulted in their harm but also to do so in person.

What Are the Apology Laws by State?

Not all states have apology laws, but Florida does.

Florida Statute 90.4026 states that an expression of condolences or sympathy by a medical professional should not be used as grounds for a malpractice suit.

This law means that it’s okay for a doctor to empathize with a patient when they experience a negative outcome after medical care or intervention. They can say, “I’m sorry this happened to you,” without that statement constituting an admission of guilt in a court of law.

However, Florida makes it clear that if a “benevolent gesture” is accompanied by an admission of wrongdoing or fault then that statement in its entirety can be used in a malpractice suit.

Additionally, while the Florida Statute does not require a doctor to apologize or express sympathy or condolences, it does require them to report to the patient any level of harm that resulted from medical treatment.

For example, if internal sutures during a surgery were not done correctly and caused internal bleeding, the doctor would be required to let the patient know rather than just ignore the situation.

When Would the Apology Law Come Into Play?

If a doctor discovers after the fact that there was more information available about the patient’s condition and that information would have altered their choices, the doctor might apologize to the patient for the choices they made medically that resulted in harm to the patient. If that apology comes with an admission of wrongdoing, then that apology would be admissible in court as evidence supporting the patient’s case.

However, if that apology did not include an admission of fault, the patient will be required to depend on other evidence of malpractice if they believe that malpractice or negligence was indeed the cause of harm.

How Does the Apology Law Impact You?

If you are dealing with the apology law in a malpractice suit, reach out to the Florida Healthcare Law Firm for assistance. We can help you address the situation and move toward a speedy resolution. Call now.

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HIPAA Law Violation

by admin on March 16, 2022 No comments

HIPAA laws are designed to protect a patient’s sensitive information, and the protection of that information can also protect the healthcare providers who curate it.

There are a number of legal structures in place to enforce HIPAA, making sure that all loopholes are closed. This means that patients have a lot of rights in regard to protection of their medical information, but it also means that even an unintentional slipup can land a healthcare employee and/or the organization they work for in hot water.

Here’s what you need to know.

What Is HIPAA Law?

Officially known as the Health Insurance Portability and Accountability Act of 1996, HIPAA law requires all healthcare facilities and any organization that manages healthcare data to have systems in place to protect that information from being released without the explicit consent of the patient.

HIPAA is a federal law, and the US Department of Health and Human Services (HSS) issued a HIPAA Privacy Rule that additionally requires that organizations implement HIPAA. Additionally, there is a HIPAA Security Rule that further protects health information.

What Is a HIPAA Law Violation?

HIPAA law is violated whenever healthcare information is released to any person, organization, or the public without consent of the individual whose information it is.

Some HIPAA law violation examples include:

  • A release of information to another doctor or healthcare provider without the explicit consent of the patient.
  • The release of information to a parent regarding any child over the age of 18.
  • The discussion of any medical information over the phone or in person.
  • The discussion of medical options with family members who are not immediately related to a patient even if there is an established long-term relationship and the person is unable to care for themselves.

Even an acknowledgement that someone is receiving services at a healthcare facility or by a specific provider is a violation of HIPAA.

For example, if someone were to call a treatment center and ask to speak to a specific patient, many organizations will refuse to even acknowledge whether or not that person is in residence or ever has been.

To provide any information regarding someone’s medical status, treatment status, diagnosis, or other issue can lead to serious legal trouble.

Can You Sue for a HIPAA Law Violation?

Yes. If you feel that your medical information was released without your consent to any party, you can sue. If you can demonstrate that there was damage to your ability to earn money, emotional damage, or any negative impact of that release of information, it is more likely that the case will be resolved in your favor.

How Do You Report a HIPAA Law Violation?

Florida Healthcare Law Firm is here to help you manage any difficulties you may be experiencing due to HIPAA law. Contact us today for more information.

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What Is Patient Abandonment?

by admin on March 11, 2022 No comments

Patient abandonment is a serious issue for patients who require continued medical support as they navigate chronic illnesses or seek a diagnosis.

When they are suddenly without treatment, they may make mistakes with their care or otherwise harm themselves inadvertently by not getting the help they need quickly enough. When the worst possible outcome results from a loss of care, it is not uncommon for their family members to litigate, indicating that patient abandonment is the reason that their loved one suffered and/or passed away.

What Is Considered Patient Abandonment?

It may be termed patient abandonment when a doctor terminates their relationship with a patient without giving them enough time and continued care to allow them to find a new doctor. In order for patient abandonment to occur, a relationship between the medical care provider and the patient must have been established.

In some cases, it is clear that there is a long and ongoing relationship between a doctor and patient, but other times, it may be implied, such as when a patient receives care in an emergency room, in a prison, or from a doctor at the request of their usual doctor who may be unavailable. Any independent medical exam may imply that there is a medical relationship between a doctor and patient as well.

What Is Patient Abandonment in Nursing?

It is possible for nurses to commit patient abandonment as well, even though they are not providing diagnostic care. If they neglect a patient or otherwise stop providing for them and do not make arrangements for another nurse to take over, they are abandoning the patient, according to the legal definition.

This is just as severe as patient abandonment committed by a physician since nurses attend to the acute needs of the patient, providing management of their treatment. If they are not there to maintain medication levels, notice when problems begin to develop, or assist patients with their basic needs, patients will suffer.

What Are the Consequences of Patient Abandonment?

The consequences of patient abandonment at best can mean frustration and fear as the patient seeks to find alternative medical care quickly. At worst, however, patient abandonment can result in the death of the patient or life-altering consequences that make it impossible for them to work or live without pain, or otherwise decrease their quality of life.

Get Help With a Patient Abandonment Lawsuit

If you need help handling a patient abandonment lawsuit, we’re here to help. At Florida Healthcare Law Firm, we are focused solely on healthcare law. We can help you work through the often emotionally difficult process of navigating the legal system with a patient abandonment lawsuit.

Call now to schedule a consultation. Find out what your options are and how we can help.

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