Laboratory Personnel and Physician Relationships

by admin on July 29, 2021 No comments

The placement of laboratory personnel in the physician’s office has been a routine arrangement in healthcare. The arrangement has been permitted under federal law, with limitations, however various states have prohibited this arrangement.  Florida has restricted this relationship by statute.

Federal regulations have been construed to allow the placement of a phlebotomist or specimen collector in the physician’s office and asserts that the placement does not necessarily serve as an inducement prohibited by the anti-kickback statute.  The OIG has previously stated when permitted by state law, the statute is implicated when the phlebotomist performs additional tasks that are normally the responsibility of the physician’s office staff. The tasks can include taking vital signs or other nurse functions, testing for the physician’s office laboratory, or performing clerical services.  Where the phlebotomist performs clerical or medical functions not directly related to the collection or processing of laboratory specimens, a strong inference arises in that he or she is providing a benefit in return for the physician’s referrals to the laboratory. (See OIG Special Fraud Alert, December 19, 1994).

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What Are Business Operations in Healthcare?

by admin on July 27, 2021 No comments

Healthcare business operations provide a strong infrastructure of administrative, legal, and financial practices that allow your business to function smoothly.

When this structure is based on a few key guidelines, your healthcare business operations are more likely to be effective, increasing transparency and decreasing confusion within the organization.

Here’s what you need to know to get your organization on track.

Why Do Business Operations Matter in the Healthcare Industry?

Whether your business serves other businesses or works directly with patients, if your business operations are solid, you are better able to provide both patients and employees with a fluid and positive experience.

When customers can count on you and employees know how to handle any given situation, there are fewer “fires” to put out, giving senior management more time to focus on expansion and special projects.

What Healthcare Business Operations Are Necessary?

Solid operation of a healthcare business plan begins with knowing where to begin and what the options are.

Here are just a few areas of focus that can take your business operations to the next level:

  • Start with what you have. You may already have systems in place that are functioning at least to a degree. Starting where you are, and assessing what needs to be fixed and what needs to be kept, can help you to get on track more quickly than starting from scratch.
  • Choose the tools that fill in the gaps. Once you have a firm idea of what is working in your business, you can specifically address the things that need your attention with new software and integrations. In some cases, this can mean upgrading current systems or making a few of the clunkier ones obsolete, but it always ends with an integrated system that provides for a more cohesive customer experience and improved employee productivity.
  • Identify the data you want to track and use in your business. Depending on the goals of your company, it will be useful to track customer habits, demographics, and needs in different ways. Building your business operations plan means identifying the data that will be most useful to your company and building in processes that track it automatically.
  • Increase the automation in your business. From the intake of prospective leads to scheduling to the processing of information, the more automation you can add into your business operations plan, the more efficient your business will be. Choosing your business plan can include setting up automatic processes that limit mistakes in processing and missed opportunities.

What Healthcare Operations Plan Is Right for My Business?

It’s always a good idea to begin with a healthcare business operations plan based on the needs of your unique business. Contact Florida Healthcare Law Firm today to set up a consultation so we can help you update your business operations.

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Genetic Testing: Be Hopeful but Wary

by admin on July 26, 2021 No comments

Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.

Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing.

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Florida Long-Term Care Pharmacy Law

by admin on July 17, 2021 No comments

Pharmacy law protects pharmacists, patients, the general public, and healthcare businesses in Florida through a number of different measures.

The details of these laws are updated regularly as new legislation is passed and old laws are changed.

It is important for healthcare industries in Florida to keep up with these changes, so they can protect their businesses and their patients.

How Does Pharmacy Law in Florida Protect Patients?

In some cases, patients may be prescribed a medication that does not work well with other medications they are taking.

The prescribing physician may not recognize that there could be a problematic interaction. Or, another physician prescribed the contraindicated medication and the second doctor isn’t aware.

Either way, a pharmacist in Florida is required by law to intervene if they see that a patient is trying to fill a script that could be lethal in combination with other prescribed medications.

How Does Florida Pharmacy Law Protect the Public?

Pharmacists in Florida are asked to fill fraudulent scripts every day by people seeking to divert addictive medications to the street.

Opioids like OxyContin and benzodiazepines like Xanax are among the most commonly abused prescription drugs, and pharmacists can often tell when the prescription is a fake.

Florida law gives pharmacists room to verify prescriptions before filling them in order to avoid filling fake scripts designed to put illicit drugs on the street.

Can Florida Pharmacy Law Protect Healthcare Businesses?

Absolutely. Laws are there to protect companies from lawsuits. By following them, healthcare businesses are better able to protect themselves and the people and businesses they serve.

Where Can I Find More Information?

If you would like to learn more about how pharmacy law in Florida could impact your business, contact us at the Florida Healthcare Law Firm today to set up a consultation.

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Can Paramedics Administer IVs at Doctor’s Offices, Clinics, or MedSpas?

by admin on July 15, 2021 No comments

There has been a lot of confusion lately as to whether Paramedics can administer IVs at doctors’ offices, clinics or MedSpas. While these professionals are trained to administer IVs during emergency transport, they are not allowed to administer IVs in most other situations.

The statutes and rules pertaining to paramedics and scope of practice fall under Chapter 401, Medical Telecommunications and Transportation, Florida Statutes, and Chapter 64J-1, Emergency Medical Services, Florida Administrative Code.

Based on definitions and the text of the statutes and rules, although a paramedic is trained to administer IVs, they can only do so during the course of emergency services and transportation and at public health care programs. Further, a paramedic’s services must be rendered under a medical director’s supervision, as the term medical director is defined under Section 401.23, Florida Statues. Under this statute, a medical director “is a physician employed or contracted by a “licensee” and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training pursuant to this part.” Section 401.23(15). Pursuant to statutes, a “licensee” means any basic life support service, advanced life support service, or air ambulance service licensed pursuant to this part.” Section 401.023(13).

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Starting a Hormone Replacement Therapy Business

by admin on July 15, 2021 No comments

Hormone replacement therapy (HRT) and other similar “body hacking” treatments have expanded significantly over the years. With more and more people choosing alternative treatments to common ailments, these practices have experienced explosive growth in response to the demand. But what does it take to open one of these businesses and how risky can it be?

  1. Understanding the Regulations
    1.  Healthcare businesses, especially in Florida, are heavily regulated. Even as a typically cash-only business, owners must stay aware of the ever-changing regulations. First, Florida and Federal anti-kickback laws affect cash-only businesses in regard to patient referrals. They also apply to laboratory referrals. Florida law has additional regulations against physician ownership in certain entities. In this case, ownership in an HRT business and a lab or pharmacy that you refer to could put you in violation of a number of Florida and Federal laws. While many HRT businesses offer other treatments that are not just hormones, the big draw is hormones, which are considered controlled substances. Prescribing controlled substances requires certain patient evaluation standards, prescribing standards, and pharmacy standards.
  2. Corporate Structure
    1. A company is considered a legal entity and recognized by both the IRS and the State. Depending on the number of owners and type of business, different options exist regarding entity type. Specifically, most healthcare businesses choose a limited liability company, corporation or a professional association, depending on the type of owner. Once you choose the appropriate type of entity, you’ll want to meet with your CPA to discuss taxation of the entity and how that affects the owners personally. Equally as important as choosing the right entity is ensuring that all corporate documents are appropriately buttoned up and protecting the owners.
  3. Licensure
    1. As a business owner, you’ll need additional business, state, county, and city government licensure to do business. Florida has many counties, each with different rules. You may need local tax licenses depending upon your offerings and services as well. In addition to business licenses, you will need to either maintain a Florida medical license or contract a physician to treat patients.
  4. Operations Planning
    1. Starting a successful practice begins months before with business planning. Develop a business plan for financing purposes, gather information regarding day-to-day operations, explore different financing options, develop a practice culture, assess bringing on any partners, and other practice considerations. You will also want to ensure that all of your patient and staffing policies are well thought out and comprehensive.
  5. Trademarks and Branding
    1. People recognize businesses by their logos, name, service, or specialists. Protecting your brand is just as important as building your business. Utilizing Federal or State trademark protections is just one method of building and creating your brand. This is at least a six (6) month process, so the earlier you evaluate your intellectual property, the better.
  6. Corporate Compliance
    1. Once you’ve built the foundations of your new practice, protecting its assets should be high on your priority list.
    2. In a high-earning business, you want to take all the necessary steps to ensure your business looks like and functions as an entity separate from yourself individually. With partners, the right agreements and actions will ensure that the company is treated as a legitimate entity.

While these are some of the biggest considerations, there are many more to opening and operating a successful HRT business.







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Noncompetes, Healthcare and a New Executive Order

by admin on July 15, 2021 No comments

On July 9, 2021, President Biden signed a far-reaching Executive Order that could have significant impact on the healthcare industry.  Under the Executive Order, President Biden:

– Encourages the Federal Trade Commission to ban or limit noncompete agreements, and to ban unnecessary occupational licensing restrictions;

– Supports the practice of state and tribal programs importing drugs from Canada;

– Directs HHS to increase support for generic and biosimilar drugs, and to issue a comprehensive plan to, “combat high prescription drug prices and price gouging” within 45 days;

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What Is Acupuncture File Law in Florida?

by admin on July 14, 2021 No comments

According to the Florida Board of Acupuncture, there are a number of requirements for would-be acupuncturists and acupuncture physicians to complete before they can legally practice acupuncture in the state.

However, too often, some medical professionals and nonprofessionals attempt to practice acupuncture in the state of Florida without the proper education and certifications.

The good news is that patients are protected by acupuncture file law in Florida.

Are There Laws in Florida Governing Acupuncture Practitioners?

Yes. Florida requires all acupuncture physicians to have completed a four-year course of study in acupuncture and Chinese medicine at a school that meets Florida Board of Acupuncture standards.

The degree program must include:

  • At least 2,700 hours of supervised instruction.
  • 20 hours in Florida statutes and rules.
  • 15 hours on universal precautions.
  • 3 hours of HIV/AIDS education.
  • 2 hours of medical error education.

Additionally, the acupuncture professional is required to have 60 undergraduate college credits, be a legal alien or resident of the U.S., and pass a written Florida examination for licensure.

Can Other Doctors Practice Acupuncture in Florida Legally?

Yes. Chiropractors with at least 100 hours of training, and osteopaths and medical doctors without any special training, may also practice acupuncture in Florida.

What Is Acupuncture File Law in Florida?

Acupuncture file law provides a way to track reports filed against physicians who practice acupuncture. In the event that they breach protocol, are found to be without the required licensure and training, or otherwise step out of bounds in their practice, a report may be filed so the Florida Board of Acupuncture can respond appropriately.

Florida acupuncture file law makes it easy for healthcare businesses that work with acupuncture physicians to ensure that their partners are keeping patients safe and practice ethically.

If you would like to learn more about how acupuncture file law may impact your business, contact us at Florida Healthcare Law Firm today to set up a consultation.

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How Medical Technology Impacts the Law

by admin on July 9, 2021 No comments

Government agencies, universities, and private corporations invest heavily in the development of medical technology.

Not only does the latest research reveal new machines and options for treatment, but they can also improve on past technology and identify where past treatment methodologies may have erred.

This is good news for patients because it means that there is an active investigation into the best treatment practices for a range of disorders.

It is also good news for labs, healthcare businesses, pharmacies, and organizations involved in telemedicine and telehealth because they can stay at the forefront of the industry and better serve their clients.

How Does Medical Technology Impact the Law?

Healthcare law is in place to protect patients and their families as they undergo medical treatment, often for serious acute or chronic illnesses.

The laws help to ensure that they get the information they need, are treated fairly, and have access to all the best possible care.

They also help to protect healthcare businesses from frivolous lawsuits, misinformation, and targeting by other businesses that want to eliminate competition.

When medical technology changes — either it becomes obsolete or is improved — it is important that the laws quickly shift to include these changes so that all parties are aware.

Why Should Florida Healthcare Law Matter to Patients?

Florida healthcare law must evolve as medical technology changes so Florida patients and benefits are protected.

Keeping up with changes in medical technology within the law can help businesses to protect their interests.

Has My Business Been Impacted by Changes to Healthcare Law in Florida?

Every business is different, and depending on your area of concern, the services you provide, and how those services are impacted by changes to medical technology, your business will need to pivot differently than another might.

If you would like to speak to a legal expert on how changes in medical technology may impact your business practices and current contracts, reach out to Florida Healthcare Law Firm today to schedule a consultation.

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SNF Reimbursement Model Leads to False Claims

by admin on July 6, 2021 No comments

Medical necessity is foundational to payment by government payers (Medicare, Medicaid, Tricare, FEHBP) for health care services.  If services are not medically necessary, any claims filed constitute false claims. In a recent DOJ False Claims Act (FCA) case, a civil settlement of a whistleblower action was reached in resolution of allegations that over a more than six-year period, a rehabilitation therapy contractor violated the FCA by causing the submission by 12 skilled nursing facilities (SNFs) of false claims for “medically unnecessary, unreasonable, and/or unskilled rehabilitation therapy services.”  Under the Settlement Agreement, the rehabilitation therapy provider agreed to pay $8.4 million to resolve the matter.


In order to understand the case, it is important to understand (at least at a basic level) SNF reimbursement.  This case arises during the time period 2010-2016 when SNFs were paid by Medicare under the Resource Utilization Groups (RUGs).  By way of background, RUGs are a prospective payment model which includes a system of grouping a SNF’s residents according to their clinical and functional statuses which information derives from the minimum data set (MDS) assessment for the resident.  Soon after adoption, many SNFs and rehabilitation therapy providers adjusted their model of care delivery to increase the level of reimbursement.  The methodology created an incentive to deliver more therapy than skilled nursing services since those RUGs were reimbursed at a higher rate.

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