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What Does the Law Say About Stem Cell Research?

by admin on October 19, 2021 No comments

Stem cell law has been heavily contested in the courts for decades in the United States, and the hotly debated topic has strong support on both sides.

In fact, it is not just at the federal level that lawmakers have been unable to reach a decision. Each state has also fought through the different permutations of stem cell research law in its own courts, and decisions are continually being overturned.

What Is Current Federal Law on Stem Cell Research?

At the federal level, there is no explicit regulation regarding stem cell research. This puts the decision into the hands of each state, according to the will of the locality.

However, federal funding for scientific research does have an impact on the developments in stem cell research and where the stem cells are resourced.

Different presidents have either put a hold on stem cell research or lifted the holds placed by their predecessor. Depending on the current state of the union, stem cell research has a greater or lesser chance of approval for federal funding.

Where Does Florida Law Stand on Stem Cell Research?

SB 954 in Florida has been batted back and forth in the state’s congress, as lawmakers seek to come to an agreement on what it means to engage in ethical research for the advancement of medical treatment.

A few of the topics included in and covered by the bill include:

  • Making sure that the Department of Health is held to a specific date by which they must adopt the new rules in the bill.
  • Ensuring that any patients who are to receive an “investigational” stem cell treatment will sign a consent form in advance to ensure they understand what is happening and what they are agreeing to.
  • Dictating that only licensed, certified, and active physicians may administer an “investigational” stem cell treatment to any patient for any purpose.
  • Requiring that all stem cell treatments be overseen by a review board put in place for that purpose.

All the specifics of the bill seem to prioritize making sure that all patients have full knowledge of what a stem cell treatment is in advance, that the treatment is administered by someone who is knowledgeable and well-trained, and that the treatment is further overseen by a governing board that will be quick to respond to any abuses of the process.

Where Can I Get More Information About Stem Cell Research Law?

If your medical business is involved in stem cell research and you would like to ensure that you are fully compliant with current law, or you want to know how pending stem cell law may impact your work, contact Florida Healthcare Law Firm today to schedule a consultation. We can assist you in remaining compliant as the law in Florida changes.

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Florida Parents’ Bill of Rights Impact on Healthcare Providers

by admin on October 14, 2021 No comments

It is well settled law that a minor cannot consent to health care services and treatment unless an exception applies.  So what is the impact of the latest legislative changes in the form of the “Parents’ Bill of Rights”?  This new law, Florida Statutes Chapter 1014, should not substantially change the way health care providers interact with minors.  It may however provide a more unified approach to parents’ rights to both making health care decisions and obtain access to the medical records of their minor children.

Below is a summary of the new Parents’ Bill of Rights law and the potential considerations and challenges for health care providers.

SUMMARY OF THE NEW LAW

The Parents’ Bill of Rights essentially prohibits infringement upon the fundamental rights of parents to direct the upbringing, education, health care, and mental health of a minor child.  The legislature believes that important information relating to a minor child should not be withheld, either inadvertently or purposefully, from his/her parent.  Under this new law, parental rights include, but are not limited to:

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How to Report an EMTALA Violation

by admin on October 11, 2021 No comments

All people in the United States have the right to emergency medical care, and the EMTALA law seeks to ensure that this right is upheld in all situations.

When it is not, those who are witness to the refusal of emergency medical services can report the violation of the EMTALA law.

What Is EMTALA Law?

The Emergency Medical Treatment and Active Labor Act (EMTALA) protects people who do not have insurance from being denied medical care due to the inability to pay for treatment.

Essentially, it is required that all hospitals and the doctors who work there provide emergency medical treatment to whomever needs it, regardless of their insurance status.

What Is an EMTALA Violation?

When a hospital or doctor employed by a hospital refuses a patient emergency medical treatment they need due to lack of insurance, it is a violation of the EMTALA law.

The fine for this violation can be as much as $50,000 for the hospital and the physician. These fines are not covered by malpractice insurance.

A further penalty could include denial of participation in the Medicare program to the hospital or doctor.

How Do I Report an EMTALA Violation?

Reach out to the local Centers for Medicare & Medicaid Services (CMS) and let them know that you would like to file an EMTALA complaint. If you prefer, you can do this anonymously.

At that point, they will take a full report from you on what happened, so they can investigate the incident and make a determination. They will need the location, date and time, names of the people involved, the extent of the injuries, and details on what exactly happened.

Do I Need Help to Report an EMTALA Violation?

No. If all you’d like to do is file a report on a hospital for an alleged EMTALA violation, you can go to CMS and they will assist you.

If you believe you require legal support due to an EMTALA violation, contact us at Florida Healthcare Law Firm today.

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How to Start a Durable Medical Equipment Business

by admin on October 5, 2021 No comments

Durable medical equipment companies provide a much-needed service in Florida, helping individuals to care for themselves and families to attend to their loved one’s medical needs in the home setting.

Here’s how you can get started setting up a new DME company.

What Is a DME Company?

A DME company, or durable medical equipment company, sells or rents medical or health care items to families that need them for an extended period of time.

Things like hospital beds, glucose and other monitors, and wheelchairs fall into this category.

Because these items are usually covered by insurance or Medicare, a DME company must be able to work with insurance companies and directly with families to help them get the products they need and that their insurance will pay for.

What Do I Need to Start a Durable Medical Equipment Business?

  • DME license: A DME license is required by the state of Florida for any person or company that sells durable medical equipment.
  • Home Medical Equipment Application Form: This form must be completely filled out accurately and submitted on behalf of each and every DME business location (even if all locations are owned by the same person or entity).
  • Background screening: A Level 2 background check will need to be passed by all who open a DME business in Florida.
  • Licensed Florida healthcare attorney: In addition to the basic Home Medical Equipment Application form, there may be additional forms and addendums that may be required, depending on the situation. An attorney can ensure that you waste no time and are in full compliance with regulations and deadlines.

Where Can I Find Help Setting Up My DME Business?

Not only can Florida Healthcare Law Firm help you with the application process as you set up your durable medical equipment business, but we can assist in setting up the business structure, filing for trademarks, and creating a business entity in the state of Florida. Call now to get started.

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Florida Law Regulates When You Can Start Working as a Chiropractor With Your Own Business

by admin on October 2, 2021 No comments

Gaining licensure to become a chiropractor is no small feat. Many new chiropractors are ready to jump into starting their own chiropractic clinic, while others prefer to work for other companies before they branch out on their own.

The choice you make should be based on your circumstances, personality, and long-term goals. It should also center on what is legally allowed in the state of Florida.

Licensed Chiropractors May Start Their Own Clinic

For chiropractors ready to start their own business, there is no Florida law standing in the way. In fact, as a fully licensed and active chiropractor, you are one of the few people in the state of Florida who can legally hire other chiropractors.

In fact, a Florida statute explicitly states that, with few exceptions, a chiropractor may not work as an employee or an independent contractor for any corporation, person, or limited liability company that is not owned by an active and licensed chiropractor.

Exceptions include businesses owned by physicians, hospitals, a clinic affiliated with a chiropractic school, a publicly traded corporation, a nonprofit, an insurance company, a HMO clinic, or a healthcare clinic that also employs other doctors.

This list of exceptions may seem to cover all scenarios, but it does limit the abilities of small businesses owned by non-physicians from hiring chiropractors. The purpose is to ensure the ability of the chiropractor to engage in their scope of practice without undue influence from a company owner that may not be familiar with the law or chiropractic care.

Avoid Chiropractor Lawsuits

The best way to avoid chiropractor lawsuits based on an employer’s status will vary by state. Many Florida chiropractors don’t realize that there are laws limiting whom they can work for.

If you are facing a lawsuit due to your employer and would like help, reach out to Florida Healthcare Law Firm today.

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Mitigating the Risk of Personal Aides in Continuing Care Communities

by admin on September 28, 2021 No comments

continuing care community law personal aid liability risk managementMore and more seniors are finding safety and security in continuing care communities (CCCs) throughout the country.  And, while they want the increased safety and security, they do not want to lose their independence.  Aging in place and maintaining that independence often involves the use of various personal service providers (PSPs) who come onto the CCC campus and create new risks.  PSPs go by many names and perform many functions, including housekeeping, meal preparation, assistance with activities of daily living (bathing, grooming, eating), grocery shopping, dog walking, and driving the resident to various offsite appointments.

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Importance of Communication During Care Transitions

by admin on September 28, 2021 No comments

Over nearly the last two years, nothing has become more evident that the importance of clear and concise communication during care transitions.  As health care facilities struggled to manage the burgeoning demand for inpatient beds, and in particular ICU beds, care transitions were fast and furious.  To facilitate care delivery and expedite care transitions, CMS issued numerous 1135 COVID-19 Emergency Declaration Blanket Waivers.  Examples (not an exhaustive list) of those blanket waivers related to required communications that may have affected the quality or safety of care during and immediately after care transitions include:

  • Allowance of audio-only telehealth for certain services.
  • Waiver of the requirement to authenticate verbal orders within 48 hours.
  • Restrictions on patient rights regarding visitation, particularly where an outbreak of COVID exists.
  • Limitations on detailed information sharing for discharge planning for hospitals and critical access hospitals.
  • Extension of time within which to complete medical records following discharge.
  • Expansion of role of allied health professionals, reduction in physician supervision requirements in certain settings, and
  • Waiver of requirement to develop and keep current a nursing care plan for each patient.
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What to Know when Buying a Veterinarian Practice

by admin on September 23, 2021 No comments

Preparing to buy a veterinarian practice may seem like a daunting task. There are many considerations, many of which usually require an expert opinion and guidance. Buying a veterinarian practice involves legal, financing, real estate, and accounting expertise, at the very least, to ensure a smooth deal with the buyer being protected. Here’s what to consider:

Legal

Buying a practice usually means buying the assets of the practice, rather than the corporation itself. In any event, the buyer is taking a significant financial and legal risk and just like any other purchase, you want to make sure that you are getting what you paid for and not any (or at least as little as possible) of the baggage. Every veterinarian transaction should include a well-drafted and thorough purchase agreement which includes substantial representations and warranties by the seller, thorough lists of included and excluded assets, terms addressing restrictive covenants, and disclosures about any potential liabilities affecting the practice. In addition, some transactions might require a portion of the purchase price to be seller financed. In that case, there will be a need for a promissory note and security agreement. As the deal progresses, there might be a need for additional documents to cover an assignment of rights for certain licenses, contracts, and other. Among other things, the final document signed includes a bill a sale, which is like a receipt for the buyer evidencing the sale of the assets.

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All You Need to Know About the Florida Patient Brokering Act

by admin on September 22, 2021 No comments

There are a number of laws in place to ensure that patients are protected and never sent out for unnecessary referrals that may be more financially than medically motivated.

For this reason, Florida has instituted the Florida Patient Brokering Act, otherwise known as anti-kickback statutes, that may impact local healthcare clinics and medical offices.

What Is the Patient Brokering Act?

The Patient Brokering Act in Florida makes it illegal for any organization to provide bonuses, split-fee arrangements, benefits, commissions, or any kickbacks for patient referrals.

This means that a specialist may not pay a commission or kickback to a general practitioner for referring a patient to their care, nor can any healthcare office offer a bonus or rebate to any patient for choosing their services.

How Did the Florida Patient Brokering Act Change Healthcare Practices?

Previously, it was normal practice for one healthcare facility to recommend a certain provider or treatment center to patients who sought care outside of the originating facility’s purview. In return, the referred party might pay a commission on the services rendered to that patient or otherwise offer a bonus or kickback of some kind for that referral.

Unfortunately, that practice resulted in a number of referrals being made for patients who may not be in medical need of that care. With the goal of generating a kickback, a referring facility might send a patient to the partner provider even if it was not for a necessary treatment. This meant that the referred facility would charge the patient’s insurance for care that may or may not be medically necessary, creating an abuse of insurance and, in some cases, putting the patient at risk as well.

What Do the Florida Patient Brokering Laws Mean for Florida Healthcare Providers?

For healthcare facilities or providers that have been charged with patient brokering, action is needed. Contacting a healthcare attorney is essential to making sure that you are fully equipped to protect your reputation and get back to focusing on what you do best.

No healthcare professionals are immune to the Florida Patient Brokering Act. Doctors, dentists, and pharmacists may all be accused of taking kickbacks for patient referrals.

Similarly, hospitals, dental offices, drug addiction treatment programs, nursing homes, and pharmacies can be brought up on the statute as well.

Are There Any Exceptions to the Anti-Kickback Statutes in Florida?

Yes, there are a few. Perhaps the most important of these is that providers within the same group practice can avoid repercussions for referrals with any financial benefit if they are for providers within the same group.

Similarly, some contracted health benefit plans can circumvent the problem as well.

If you are facing charges due to the Florida Patient Brokering Act, reach out to the Florida Healthcare Law Firm today and set up a consultation.

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What’s New with Regenerative Medicine?

by admin on September 21, 2021 No comments

The field of regenerative medicine is ever expanding and evolving. As more viable options become available to patients, it’s important to stay abreast of regulation surrounding many of these applications.

In late 2019, the Food and Drug Administration (FDA) began informing the public of multiple reports of serious adverse events experienced by patients who were “treated” with non-FDA approved products marketed as containing exosomes. As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements. At the time of the 2019 warning, there were no FDA-approved exosome products and the FDA since then has not put out any new guidance.

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