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Compliance Update
Clinical Research & Healthcare Regulatory Compliance Print E-mail
Written by Jeffrey L. Cohen   
Monday, 21 August 2017 00:00

Doctors often consider the idea of clinical research to be an easy "add on" to their practices. The usual idea is "I already have the patients. This'll be easy." But that's not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies ("Sponsors") are often looking for resources for clinical research. They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity regarding the efficacy of a tested drug.

Medical practices that think it'll be easy to become a Site will be very surprised by some of the key challenges, which include...

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Top Employment Law Myths Every Healthcare Practitioner Needs To Know Print E-mail
Written by Robin I. Frank   
Wednesday, 09 August 2017 17:06

Owning and operating a successful company in the healthcare arena requires compliance with a myriad of employment laws. Whether you are a medical practice, a research clinic or a health records coder, there are laws that govern your business – aside from HIPAA. Failing to comply with these laws can result in an expensive lesson. There are many employment law myths that business owners in the medical industry face in the context of overtime and minimum wage laws that can lead to serious consequences, but there are also steps that they can take to avoid those repercussions.

The federal overtime law applies to employers regardless of the number of employees. Moreover, employees cannot waive their right to overtime – period. In the unlikely event that a front desk person, for example, signs a contract agreeing that he or she will not be paid overtime, that person can still sue for the unpaid overtime. In fact, this is why employees sue employers for unpaid overtime or minimum wage violations more often than for any other reason.

Many business owners – in healthcare and in numerous industries – wrongly assume that if an employee works overtime without advance approval, in violation of a written policy, they do not have to pay for that overtime. This is not the case. If the company knows, or has reason to know, that the employee is working overtime, it is liable and must pay for that overtime. Disciplining the employee for violating the policy may be in order, but not paying is not an option. Healthcare providers and business owners operating smaller companies in the healthcare industry often do not maintain accurate time records. In the overtime context, it is the employer’s obligation to keep and maintain accurate time records. A work schedule does not constitute an accurate time record. If, for example, a nurse, who is not exempt from the overtime requirements, has an especially busy day, or the data entry person spent extra time on new data that required input, and there are no accurate time records, the law allows the employee to merely estimate the number of hours worked in the event of a lawsuit. This could be as simple as the employee stating that she worked an average of “X” number of hours per week. Moreover, if she recovers even one penny in unpaid overtime, the practice likely will be required to pay double that amount as a penalty. The overtime law also requires the employer to pay the employee’s reasonable attorney’s fees if the employee wins. If the employer wins, in most cases the costs cannot be recouped.

As stringent as HIPAA compliance is, that’s how unforgiving the federal overtime law is for employers. In fact, it is almost entirely skewed in favor of the employee. For example, even if a medical assistant or orderly is an illegal immigrant, and therefore has no right to work in this country, that person can still sue for unpaid overtime and the law requires the owner to pay him or her for that overtime. The medical practice may also be subject to penalties for hiring an illegal worker in the first place, and liable for unlawful retaliation if the owner reports this worker to the immigration authorities. Moreover, whether or not they are owners, individuals who have the authority to hire, fire, and set pay rates and/or work schedules can be held liable for unpaid overtime and minimum wages. Additionally, successor companies are often substituted in after the fact. So closing down the practice or bankrupting it is not an effective solution.

Another problem area is misclassifying employees as exempt from the overtime laws, an issue that is not uncommon among medical professionals. “Classifying” employees as exempt does not guarantee that the law will see them as such. Paying an employee a salary or giving him or her the title of manager does not mean the employee is not entitled to overtime. Paying a salary simply changes how to calculate the overtime rate. Likewise, only certain types of jobs are exempt from the overtime requirements. A nurse or physical therapy assistant must be paid a minimum salary in order to be exempt; however, being paid a salary alone does not make the nurse or therapist exempt from the overtime law. Exemptions focus on the employee’s actual day-to-day job duties and responsibilities, and not the job title. For example, licensed practical nurses and similar healthcare employees do not generally qualify as exempt, regardless of work experience and training, because possession of a specialized advanced academic degree is not a standard prerequisite for entry into such occupations. Likewise, home health aides, companions, sitters, personal care attendants, and live-ins may or may not be exempt from the overtime and minimum wage requirements. Some are exempt from both, others are only exempt from the overtime requirements, and others are not exempt from either. It is a factually-intensive analysis performed on a case by case basis. In other words, it can be a costly mistake for providers or business owners to make this determination themselves.

The best thing professionals who own or manage a medical or healthcare company can do to protect themselves is to maintain accurate time and pay records and consult with an attorney who is experienced in labor and employment law.

About the author:
Robin I. Frank is a Partner with Shapiro, Blasi, Wasserman & Hermann, P.A. one of the largest independent full-service litigation and transactional law firms in South Florida.  She focuses on labor and employment law and has extensive experience both prosecuting and defending against nationwide “collective action” claims for unpaid overtime or minimum wages under the Fair Labor Standards Act. She may be reached at (561) 477-7800 or

Last Updated on Wednesday, 09 August 2017 17:21
OIG Cracks Down on Hospice Provider Fraud Print E-mail
Written by Vitale Health Law   
Monday, 17 July 2017 00:00

Last year, the HHS Office of the Inspector General stated the hospice fraud was rampant and that it would be an enforcement priority for the agency. The OIG found that some hospice operators, doctors and staff were recruiting patients to maximize profits, even when in some cases the patients didn't need hospice care. Their illegal activities amounted to hundreds of millions of dollars.

This month, we are seeing the results of OIG's crackdown. On July 6 alone, the U.S. Department of Justice announced three cases involving hospices and healthcare fraud totaling approximately $15 million.

One case involved the defunct Home Care Hospice, Inc. (HCH), a Philadelphia-based company that the feds said falsely claimed and received taxpayer dollars for hospice services that either were unnecessary or never provided. The case grew out of a whistleblower suit filed against the owners and operators of Home Care Hospice.

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Last Updated on Wednesday, 19 July 2017 12:03
Consultant & Lawyer Fatigue No More! Print E-mail
Written by Jeff Cohen | Florida Healthcare Law Firm   
Sunday, 11 June 2017 00:00

Healthcare regulatory compliance is often performed by consultants who are not lawyers. This can create tension between the professionals, since they may see the same issue differently. Moreover, since healthcare consultants often deliver their services directly to clients (not through healthcare legal counsel), the process loses the protection of the attorney client privilege.

Clients might not appreciate the need for both consultant and legal services, especially given the expense. And many times lawyers will likely tell their clients they lack the expertise to weigh in on the consultant's service, which can leave all parties feeling like they are working without a net. Additionally, many consultants are rare enough to have to be brought in from out of state. Which may lead to them providing terrific federal compliance guidance and missing issues of state law based regulatory compliance altogether. Moreover, given the web of healthcare regulatory compliance requirements, it's easy for a client to think their coding consultant is all they need.

It's just unrealistic to expect a healthcare professional or healthcare business to even know all the questions to ask. The fact is there are key differences between legal and regulatory compliance and legal and regulatory consultants. They bring difference experiences and unique perspectives to the table. And misunderstanding the gap between the different regulatory landscapes they cover can create serious gaps in compliance and liability for healthcare providers and healthcare businesses.

The best possible product for a healthcare client will involve BOTH expert consulting in a specific area and also expert healthcare legal counsel review and input. Given the risks associated with missing issues like HIPAA, self-referral, kickback, brokering and current "environmental factors," clients can't afford to oversimplify their legal and regulatory compliance  processes. Without the combination, the consulting process is vulnerable to scrutiny and risky gaps.

Someone once said something like "To a carpenter, everything is a nail." We all tend to view challenges and solutions in our work world through a perspective of specific (and limited) experience. It's therefore essential to healthcare professionals and businesses that they have around their table people who collectively bring the broadest applicable perspective and experience to ask the right questions, the ones clients may not even know to ask. A HIPAA expert, for instance, will dig deep into the patient privacy issue, but may not think to ask about exposure the client may have to payers. A coding expert would likely not think to inquire about or identify exposure on issues related to self-referral, or safe harbor compliance.

The best possible legal and regulatory compliance product for a healthcare client is one that blends expert consulting services with expert healthcare legal compliance.

With over 30 years of healthcare law experience, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law.  With a strong background and expertise in healthcare law corporate matters, particularly as they relate to healthcare professionals and businesses, Mr. Cohen’s practice immerses him and the lawyers of the firm in regulatory, contract, corporate and compliance.  As Founder of The Florida Healthcare Law Firm, he has distinguished himself and his firm for providing exceptional legal services with the right pricing, responsiveness and ethics. He can be reached at

Last Updated on Monday, 12 June 2017 18:34
A Hospital's Deserving Stark and AKS Victory-But At What Cost? Print E-mail
Written by   
Monday, 05 June 2017 00:00

This April, providers cheered when a federal district court in the Middle District of Florida found insufficient evidence to support a relator's theory that a hospital had provided free parking to physicians, in violation of the Stark Law and Anti-Kickback Statute (AKS). In the Report and Recommendation for United States ex rel. Bingham v. BayCare Health Systems, 2017 WL 126597, M.D. Fla., No. 8:14-cv-73, Judge Steven D. Merryday of the Middle District of Florida endorsed magistrate judge Julie Sneed's recommendation that Plaintiff Thomas Bingham's Motion for Partial Summary Judgment be denied and that Defendant BayCare Health System's Motion for Summary Judgment be granted.

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