IV Therapy Clinics: Take Note of IV Supervision Requirements

by admin on August 18, 2021 No comments

As IV therapy clinics become more and more popular, the question to follow is, who can place the IV line and under what supervision? You would expect that first responders like Emergency Medical Technicians (EMT) would be able to start lifesaving IV lines on their own since they are the life support in between an incident and the emergency room. Contrary to what one might think is an “appropriate” ability or function of emergency personnel, under Florida law, EMTs are actually not permitted to place their IV lines on their own outside of an emergency situation. While there might be some very narrow exceptions, the general rule is clear in its prohibition.

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Common Business Transaction Issues in Healthcare

by admin on August 15, 2021 No comments

Business transactions are commonly the cause of litigation for healthcare businesses that are without the support and protection of a healthcare law firm.

Through the provision of correct business structures, best practices, policies, and procedures, a healthcare law firm can ensure that your healthcare business is protected from regulation violations, malpractice issues, and more. This starts with separating out different business transactions that are required for different parts of the practice.

Why Separate Business Transactions in a Healthcare Business?

One of the most common problems that occur in healthcare businesses is declining to implement different business structures as appropriate for different types of transactions made in the business.

An example of a business transaction for a healthcare business is the payment for supplies and services related to the business. Handling creditors is very different from how a healthcare business might pay for marketing services as there are different rules regulating those transactions.

Creating protocols for how to handle creditor payments will emphasize the rights and limitations of creditors as well as identify the responsible party or parties for payment in the business. This is an important point if there are doctors/owners coming in and out of the business, and creditors are paid over months or years.

What Are Other Examples of Business Transactions in Healthcare Businesses?

Healthcare businesses handle a number of transactions throughout the day, and it is important to have protocols in place to increase efficiency. Should there be a disruption to one part of the business, separation of transactions will allow for the continued flow and function of other aspects of the business while the disruption is addressed.

Other examples of business transactions in healthcare businesses, include:

  • Responsibility and protocol for day-to-day front desk operations.
  • Supervision of ongoing client projects, patients, or customer care.
  • Organization of back-end business practice.
  • Overseeing compliance with state, federal, and local regulations.
  • Management of marketing and advertising needs.
  • Troubleshooting and maintenance of software, machinery, and IT issues.

Take the time now to contact Florida Healthcare Law Firm and get started creating a protocol for managing the business transactions in your healthcare business.

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All You Need to Know About Medical Devices Regulations

by admin on August 11, 2021 No comments

Medical devices of all kinds are regulated by the Food and Drug Administration (FDA) in the United States.

Healthcare businesses that create medical device products are required to stay up-to-date with current medical device development regulation and law and to ensure that they are in compliance at all times.

It is also important for healthcare businesses that use medical devices to stay in the know when it comes to product regulation changes and updates.

What Are Medical Devices?

Medical devices include any component, accessory, part, machine, instrument, apparatus, implant, or in vitro reagent that is used for the purposes of diagnosing, preventing, mitigating, or treating a medical condition or disease.

Some combination products that are a device but also biologically inserted into the body and/or release a drug into the body are included in medical device laws.

Medical device regulations exclude drugs and certain software that manage administration of a medical office or support the storage of patient records.

What Is Pharmaceutical and Medical Device Law?

Medical device law and pharmaceutical device law codify medical devices according to different levels of risk and controls. For example, Class I medical devices are the lowest risk, and Class III medical devices have the highest risk.

Depending on the class of the medical device, medical device law and regulations may require:

  • Labeling that provides user information.
  • Medical device reporting of injuries or death that are related to use of the device.
  • Registering the business and all devices with the FDA.
  • Implementing a quality control system.
  • Avoiding misbranding or other misinformation.

Does Your Business Need Help Maintaining Medical Device Regulation Compliance?

Contact Florida Healthcare Law Firm today to discuss potential issues you may be facing due to medical and pharmaceutical device law. You’ll get the support you need to create a compliance plan and avoid any potential legal violations and legal restraints from the FDA.

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What Is a Laboratory Compliance Specialist?

by admin on August 6, 2021 No comments

There are very strict rules and regulations in place for any business working in a lab, both to protect the healthcare professionals working in that lab and the clients and customers the lab serves.

To make sure that your company is in compliance with these laws, it is recommended to hire a laboratory compliance specialist to double check the details and make sure that all processes are up to code.

What Is Laboratory Compliance?

Laboratory compliance is an ongoing effort put forth by healthcare businesses to ensure that they are up-to-date on all licensing and regulatory requirements.

State, local, and federal agencies may require compliance with a long list of ever-changing rules and directives. It is the responsibility of the business to maintain awareness of those regulations and to ensure that they are operating according to standards and providing proof of that when necessary.

Laboratory Compliance Specialist Definition

When it comes to maintaining laboratory compliance, a laboratory compliance specialist is essential. Sometimes called compliance officers, these professionals are responsible for keeping up with the latest changes and requirements and making sure that the company is doing everything they need to do.

This doesn’t just mean coming in once a year to check that everything is in compliance or responding when there is a violation. It means creating a compliance program that includes policies, processes, and procedures that ensure continual compliance.

Additionally, if there is an audit, investigation, or suspicion of a violation, the laboratory compliance specialist will dive into the problem, handle whatever results from the audit, and adjust policies and procedures accordingly.

Does Your Healthcare Business Need a Laboratory Compliance Plan?

Learn more about how laboratory compliance can impact your healthcare business legally and create a laboratory compliance plan that will protect you in court when you call Florida Healthcare Law Firm now.

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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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