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FMV (Fair Market Valuation) Heads Up

by admin on February 26, 2021 No comments

By: Jeff Cohen

FMVs are at the heart of healthcare regulatory compliance when money or anything of value changes hands in a healthcare business setting.  Why?  Two reasons:

  1. Healthcare laws (Stark, the Anti Kickback Statute and the Patient Brokering Act) all target money changing hands in the healthcare business space; and
  2. There are clear exemptions and exceptions that have as an essential ingredient that the compensation (or pricing) is consistent with “fair market value.”

How it Goes—A Six Part Process

Locking down an externally performed FMV (part of the “gold standard” in regulatory compliance) is a process.  Here’s what it should look like:

Step 1.  The healthcare business person or his/her advisors (often accountants) find someone who specializes in performing FMVs for the specific matter (e.g. compensation, price of a business to be acquired);

Step 2.  The LAWYER for the healthcare business is immediately involved in the process BEFORE the FMV firm is engaged;

Step 3.  The LAWYER engages the FMV firm on behalf of the healthcare business client;

Step 4.  The parties (including the lawyer) get on the phone or in a meeting with the “FMV guy” and has a very extensive conversation re the project;

Step 5.  Once the FMV process done, a DRAFT FMV study is prepared and discussed interactively with the healthcare business and the lawyer;

Step 6.  Once finalized, an execution copy is prepared and provided to the lawyer.

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Autonomous Nurse Practitioners in Private Practices

by admin on February 22, 2021 No comments

By: Chase Howard

The new autonomous practice regulations allow certain Nurse Practitioners to practice independent of physicians, without supervision, in certain settings. While we’re awaiting further declarations and definitions from the Board of Nursing as to what is including in primary care, there is already an opportunity for autonomous practice nurse practitioners to establish concierge and direct primary care offices.

The concierge practice model and the direct primary care model, however, are still regulated depending on the way patients pay.

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Supervision of Electrologists

by admin on February 22, 2021 No comments

By: Chase Howard

Changes are coming to the way Electrologists in Florida may be supervised when performing laser hair removal. For years, direct, on-site supervision by a physician was required in order to allow an electrologist to perform laser hair removal. Recently, the Board of Medicine and Electrolysis Council agreed to a rule change, altering the method of supervision to include telehealth.

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3 Ways to Prepare for a Compliance & Regulatory Services Consult

by admin on February 10, 2021 No comments

compliance and regulatory servicesAt our health law firm, we offer complete and thorough compliance and regulatory services consults. Here’s how we ask our new clients to prepare for our visits. 

At the Florida Healthcare Law Firm, we meet with hospital, health plan, and clinic executives every day. We build audit schedules that work, and we conduct training programs to keep staff on track. 

While we’re both quick and efficient, we do rely on our clients to prepare for visits from the health law firm. Here’s what we ask all new clients to do. 

  1. Collect All Compliance & Regulatory Services Training Materials 

A lack of staff training often leads to privacy or other legal violations. To conduct an analysis and ensure we’re building the right plan, we must know how you’re working with new staff. 

We’d like to see these documents:

  • Employee manuals 
  • HIPAA training documents 
  • Staff evaluation forms 

Anything you’ve given your staff to help them learn the rules is appropriate for our study and perusal. 

  1. Gather Important Staff to Meet With the Health Law Firm 

We’ll conduct an initial discussion with a leader within the organization. But at some point, we’ll want to talk with plenty of people in charge. 

We might want to speak to these people:

  • IT manager
  • HIPAA compliance officer 
  • Human resources director 
  • Marketing director 

We might also like to talk with anyone who trains new employees or negotiates contracts on your behalf. Knowing who these people are right now and ensuring they’re available to speak with the health law firm will save time.

  1. Document Past Legal Issues 

One medical malpractice payout happens every 43 minutes in the United States. If you’ve had difficulty with compliance and regulatory services in the past, you’re not alone. And we’ll want to know everything about what went wrong. 

Pull together any documentation related to your past lawsuits, including summons information, payouts, and defense strategies. We’ll also want to know what you’ve done to prevent similar problems in the future.

We Are Here to Help 

Consider us the health law firm in Florida. Our talented and experienced team is here to help organizations both large and small, and it’s easy to get started. Schedule a consultation today. 

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A Self-Audit Checklist for Laboratories

by admin on February 9, 2021 No comments

By: Dean Viskovich

The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans.  The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs.  The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished.  Compliance plans offer a vehicle to achieve that goal.  The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.

The OIG suggests that the comprehensive compliance program should include the following elements:

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Health Care Clinics Targeted For Medical Director Requirements

by admin on February 9, 2021 No comments

By: Zach Simpson

There have been a rise in cases recently, in which practices that operate under a Health Care Clinic License have been brought under scrutiny by insurance companies trying to recoup funds through any means possible. In an effort to claw back funds insurance companies are beginning to claim that medical directors are failing to meet their statutory obligations under Florida Law which in turn can have serious monetary repercussions. Due to the clinics allegedly failing to meet their statutory obligations the insurance companies are filing suit to recoup any payments made while violating the Health Care Clinic Act obligations, and to stall any future payments due until such cases are heard.

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. The type of services provided at a clinic may dictate who would be able to serve as a clinic’s medical director, because a medical director must be authorized under the law to supervise all services provided at the clinic.

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A Business Law Lawyer in Florida: A Healthcare Organization’s Best Friend

by admin on February 9, 2021 No comments

business law lawyer floridaDon’t face legal challenges alone. A business law lawyer can help you address problems head on, and together, you can craft programs to help you avoid future headaches. Learn how.

Far too many healthcare organizations believe they can head off legal challenges (or prevent them from cropping up in the first place) without the help of a business law lawyer. 

As one of the top firms offering business law lawyers in Florida, we’re here to tell you this just isn’t true. 

Every healthcare organization deserves competent, qualified legal counsel. Those that invest in help tend to experience far fewer complications than their counterparts do. 

Let us explain. 

3 Cringeworthy Medical Law Examples 

A business law lawyer is concerned with the ins and outs of the way you run your organization. The details may seem small and insignificant. But get them wrong, and the consequences can be severe.

Here are three recent examples any executive would be wise to study:

  1. Data sharing: A medical center in Chicago formed a partnership with Google to explore how technology could uncover hidden medical conditions. Patients allege that the documentation shared violated their privacy. 
  2. Crisis management: A hospital in Iowa faced many different lawsuits coming right after the other. The team allegedly attempted to bury the news, which became a reputation problem. 
  3. Employee spending: A hospital in Kentucky held back money from paychecks to cover health insurance premiums. Officials allegedly used the money for other purposes. 

In some of these examples, a business law lawyer could have averted disaster. In others, counsel could clean up the mess and prevent future problems. 

How to Hire a Business Law Lawyer 

Plenty of legal professionals specialize in the details of corporate affairs. But medical teams need a little bit more. The rules and regulations that surround healthcare are obtuse, and an expert can do more than a novice. 

If you need help from a business law lawyer in Florida, consider our firm. We have decades of combined experience in serving hospitals, health plans, and other affiliated clinics. We’d love to talk with you. 

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When Was Your Last Regulatory Compliance Audit?

by admin on February 9, 2021 No comments

health care professionals attorneyRegulatory compliance audits can help you head off lawsuits before they get started. Learn how to set a schedule based on your organization’s unique risks and benefits, and let trained legal counsel help you. 

As a healthcare executive, it’s your job to craft policies that protect your patients, your staff, and your community. Regulatory compliance audits help you do your work effectively. But if you dread them, you’re not alone. 

It’s not uncommon for organizations to postpone and delay compliance work. No one likes the hassle. But a healthcare practice attorney could help you both set up an audit schedule and complete your tasks with ease. 

When Is a Regulatory Compliance Audit Required?

Every healthcare organization faces a unique set of compliance risks. It’s critical for you to understand your environment intimately and design your audit schedule accordingly. 

Typically, regulatory compliance audits are performed:

  • On a schedule. If your organization is large and includes plenty of service lines, you’ll need to assess risks more frequently than a smaller, targeted organization. 
  • After an issue is detected. Some healthcare legislation requires proof that you’ve learned from your mistakes. If a compliance problem appears, an audit can help you determine how it happened and what you can do to prevent the next issue. 
  • After hefty staff turnover. Everyone on your team must understand how the rules work and why they are important. That’s not always easy for health professionals. Attorney support can be critical. 

Your schedule may change as your organization grows or shrinks. And you may need more audits one year than another. Flexibility is critical. 

Why Do Healthcare Practice Attorneys Perform Audits? 

If you’re a do-it-yourself executive, the thought of hiring someone to help you achieve compliance may seem unusual or strange. But the benefits are both real and plentiful.

A healthcare practice attorney can offer you:

  • Confidentiality. The information gleaned during the process remains between the two of you, and it’s protected from disclosure. 
  • Expertise. The rules and regulations you must follow can be hard to both read and understand. Healthcare practice attorneys specialize in these sorts of documents, and they can explain them to you quickly and carefully. 
  • Impartiality. It’s easy to make excuses for your employees (and yourself). Professionals can look over your records dispassionately, so you can make smart decisions. 

At Florida Healthcare Law Firm, we specialize in regulatory compliance audits. Our healthcare practice attorneys can walk you through the laws and help you stay on the right side of the law. Contact us to find out more about how these audits work and how you can get started.

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The Most Important Role in the Clinical Lab Space: Lab Director

by admin on February 8, 2021 No comments

By: Dean Viskovich

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988.  CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.  In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations.  The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.

The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA.  CLIA prohibits a laboratory director from directing more than five non-waived laboratories.  Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position.  The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position.

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A DME Fraud of Epic Proportions

by admin on February 8, 2021 No comments

dme telemedicine fraudBy: Michael Silverman

Almost two years after “Operation Brace Yourself” regarding purported telemedicine and orthotic bracing fraud made national headlines, on February 4, 2021 the Department of Justice Announced that a major player in that fraud – Florida businesswoman Kelly Wolfe – recently pled guilty to criminal health care and tax fraud charges.

Operation Brace Yourself was a 2019 crackdown on the illegal use of telemarketing and telemedicine to generate fraudulent claims for DME orders, whose reach spanned continents and ultimate implications defrauded taxpayers out of billions of dollars.

According to the Department of Justice Press Release and Settlement Agreement, Mr. Wolfe was seemingly a significant mastermind in establishing hundreds of DME companies that went on to defraud US taxpayers and Medicare beneficiaries.

Here are some highlights of the recently signed Settlement Agreement between the United States DOJ, Kelly Wolfe and her company Regency, Inc.

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