Florida legislature | The Health Law Firm Blog

Chiropractors Not Allowed to Work for Clinics Owned by Non-Chiropractors in Florida, with Limited Exceptions

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Apparently there are many chiropractic physicians and other medical business owners who are unaware of the prohibition provided in Florida law against a chiropractor providing services for a business owned by non-chiropractors. By non-chiropractor, this means anyone who does not have a current, active Florida chiropractic physician’s license.

The prohibition for chiropractors was passed into law in Florida originally in 2007. The law was amended in 2012. There had previously been similar prohibitions that applied to dentists and optometrists. To read the article I wrote on these issues, click here.

What’s the Purpose of This Law?

Found in Section 460.4167, Florida Statutes, the law states that a person (which includes a corporation or limited liability company), may not engage the services of a chiropractor as either an employee or an independent contractor to provide chiropractic services, except under a limited set of circumstances. To see the complete text of Section 460.4167, Florida Statutes, click here.

The purpose of the Florida Legislature in passing this law is set forth within the law itself. Subsection 4 of the law states:

The purpose of this section is to prevent a person other than the licensed chiropractic physician from influencing or otherwise interfering with the exercise of the chiropractic physician’s independent professional judgment. In addition to the acts specified [elsewhere in the statute], . . . a person or entity other than [the ones excepted] . . . may not employ or engage a chiropractic physician licensed under this chapter.

Exceptions to the Law.

There are, of course, exceptions stated in this law for organizations that are allowed to employ or contract with chiropractors. These include:

1. Business entities owned solely by chiropractors (licensed in Florida) and their immediate family members.

2. Business entities owned by medical, osteopathic or podiatric physicians licensed in Florida.

3. Business entities owned by hospitals.

4. A clinic that trains chiropractic students that is affiliated with an accredited chiropractic college.

5. A public or private college or university.

6. A business entity that is owned by a corporation that is tax exempt under certain Internal Revenue Service regulations (not-for-profit corporation).

7. A publicly traded corporation.

8. An insurance company licensed in Florida.

9. An HMO or prepaid health clinic (as set forth in chapter 641, Florida Statutes).

10. A clinic licensed as a Health Care Clinic under Florida Statutes, which provides chiropractic services by a licensed Florida chiropractor and also provides other health care services by medical doctors or osteopathic physicians, the medical director of which is licensed under chapter 458 (medical doctors) or chapter 459 (osteopathic physicians), Florida Statutes.

Special Exception for Clinics Licensed Under Florida’s Health Care Clinic Licensure Act.

This last exception, one for clinics licensed under Florida’s Health Care Clinic Licensure Act (Section 400.990, Florida Statutes), provides perhaps the broadest exception. A clinic that is properly licensed by the Florida Agency for Health Care Administration (AHCA), and meets the other requirements of the law, can be legally owned by non-chiropractors or non-physicians, and chiropractors may legally contract with or be employed by them. The safeguard is that the licensing requirements in Section 400.990 must be met, and physician services other than just chiropractic services must be performed at the clinic.

However, even under the exception provided by the Health Care Clinic Act, any agreement or other arrangement with the chiropractic physician whereby the other person (or an entity) provides the chiropractor with chiropractic equipment or chiropractic materials must contain a provision whereby the chiropractic physician expressly maintains complete care, custody and control of the equipment or practice.

To see the complete text of the Florida Health Care Clinic Act, click here.

Violating the Law Puts Your Professional License in Jeopardy.

If the business entity, clinic or group does not fall squarely within one of the exceptions listed above, the chiropractor may not legally be employed by or provide chiropractic services for it. The penalties for violating this law include:

1. Prosecution for a felony in the third degree.

2. Any contracts associated with the services are void.

3. Disciplinary action against health care licensees pursuant to chapter 456 or chapter 460, Florida Statutes.

4. By implication, since any contracts in violation are void, then any fees or bills for services in violation of the act are also void.

Don’t jeopardize your professional license, your reputation, your assets or your liberty by risking a violation of this act. Consult with an experienced health lawyer on any such business venture or proposal.

Contact a Health Care Attorney Experienced in Negotiating and Evaluating Physician and Health Professional’s Business Transactions.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, chiropractors, psychologists, psychiatrists, mental health counselors, durable medical equipment suppliers (DME), medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider.

The services we provide include reviewing and negotiating contracts, preparing contracts, helping employers and employees enforce contracts, advice on setting aside or voiding contracts, litigation of contracts (in start or federal court), business transactions, professional license defense, opinion letters, representation in investigations, fair hearing defense, representation in peer review and clinical privileges hearings, litigation of restrictive covenant (covenants not to compete), Medicare and Medicaid audits, commercial litigation, and administrative hearings.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Were you aware of this law and its exceptions? Please leave any thoughtful comments below.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Optometrists and Ophthalmologists Not Seeing Eye to Eye Over Proposed Law Allowing Prescribing

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

This year Florida House Bill 239 and Florida Senate Bill 278 has been reignited in the Florida Legislature. This legislation is pitting optometrists and ophthalmologists against each other in what is being called the “eyeball wars,” according to the Fort Myers News-Press. These bills would expand the authority of optometrists to prescribe certain medications and treat some eye conditions. Optometrists and ophthalmologists are both trying to gain support for their respective viewpoints.

Click here to read the article from Fort Myers News-Press.

Florida House Bill 239 and Florida Senate Bill 278.

Most notably, the bills would expand the scope of practice for optometrists. Optometrists would have prescribing authority of oral medications. However, they would not have the ability to prescribe Schedule I and II narcotics. Optometrists would also be allowed to perform clinical laboratory studies.

Click here to read Florida House Bill 239, and click here to read Florida Senate Bill 278.

Supporters Believe This Law Would Reduce Health Care Costs and Increase Access to Eye Care.

The backers of expanding prescribing authority to optometrists say it will help reduce health care costs and make treatment more available to communities short on ophthalmologists. According to a statement by the Florida Optometric Association, expanding the ability for optometrists to prescribe oral medications saves money, increases access to eye care, and saves people from losing vision due to treatment delays. According to the Fort Myers News-Press, this authority has been granted to optometrists in 48 states.

Ophthalmologists Say Patients’ Safety is at Stake.

According to the Florida Society of Ophthalmology, allowing an expansion of prescribing authority is a dangerous move for patients. A letter from the American Academy of Ophthalmology states that the language in the legislature is vague, broad and misleading. It also states that the training ophthalmologists receive provides them with not only technical skills, but instills the judgment one needs to determine when (and when not) to prescribe specific medications. To read the entire letter, click here.

Other associations opposed to the bill include Florida Society of Interventional Pain Physicians, Florida Society of Rheumatology, Florida Society of Anesthesiologists, Hillsborough County Medical Association. Letters written by each of these societies can be read by clicking here.

Progression of the Bill.

Florida House Bill 239 was passed by the House Health and Human Services Committee on March 7, 2013, and is now ready for the House Floor. On March 6, 2013, a Florida Senate panel voted 10-3 to approve Senate Bill 278. The bill has now been handed over to the Appropriation Committee.

Contact Health Law Attorneys Experienced with Investigations of Optometrists and Ophthalmologists.

The attorneys of The Health Law Firm provide legal representation to optometrists, ophthalmologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of optometrists being able to prescribe oral medication? Are you for or against this legislature? Please leave any thoughtful comments below.

Sources:

Gluck, Frank. “Not Seeing Eye to Eye: Optometrists, Ophthalmologists Differ on Bills.” Fort Myers News-Press. (March 7, 2013). From: http://www.news-press.com/apps/pbcs.dll/article?AID=2013303070027&nclick_check=1

Corcoran, Richard. Letter Opposing HB 239 and SB 278. American Academy of Ophthalmology. (February 4, 2013). From: http://www.mdeye.org/pdfs/AAOHB239OppositionLetter.pdf

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

It’s the End to the Eyeball Wars-Optometrists and Ophthalmologists Come to an Agreement: Optometrists Allowed to Prescribe

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On April 4, 2013, the Florida Senate passed Florida Governor Rick Scott a hard-fought bill that would expand the drug-prescribing practices of optometrists, according to the Associated Press. House Bill 239 has pitted optometrists against ophthalmologists for years in what was called the “eyeball wars.” (Click here to read House Bill 239.) The Senate sent a measure to the governor that would allow optometrists to prescribe some medications, while adding new patient protections.

To read the article from the Associated Press, click here.

I previously blogged about this topic when the bill was still being voted on in the House. Click here to read what supporters and opponents of House Bill 239 had to say about it.

The Final Bill-Optometrists to be Allowed to Prescribe.

According to an article in the Orlando Sentinel, the final bill was an agreement between the Florida Society of Ophthalmologists and the Florida Optometric Association. Optometrists wanted to ability to prescribe medications other than ointments and creams. Ophthalmologists argued optometrists are not doctors and did not receive the proper training to prescribe medicine.

The compromise under the final bill says optometrists would be allowed to prescribe 14 oral drugs, including antibiotics. However, optometrists will not be allowed to prescribe controlled substances. The measure clarifies that optometrists cannot perform surgeries and requires them to report any bad medical outcomes to the state, as ophthalmologists are required to do.

Click here to read the entire article from the Orlando Sentinel.

Hopes for House Bill 239.

State Senators voted 40-0 to pass the bill. Optometrists believed that House Bill 239 will help Floridians get the most appropriate eye treatment. This bill will also allegedly help cut down on duplicate services, and in return, reduce costs for patients.

If Governor Scott signs the bill, it will officially put an end this turf war over eyes.

Contact Health Law Attorneys Experienced with Investigations of Optometrists and Ophthalmologists.

The attorneys of The Health Law Firm provide legal representation to optometrists, ophthalmologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the new bill? Do you think optometrists prescribing medication is a good idea or a bad idea? Please leave any thoughtful comments below.

Sources:

Associated Press. “Bill Expands Prescribing Powers for Optometrists.” The Tampa Bay Tribune. (April 4, 2013). From: http://hosted.ap.org/dynamic/stories/F/FL_XGR_OPTOMETRISTS_FLOL-?SITE=FLTAM&SECTION=STATE&TEMPLATE=

Haughney, Kathleen. “Eyeball Wars Comes to an End.” Orlando Sentinel. (April 4, 2013). From: http://blogs.orlandosentinel.com/news_politics/?p=42985

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Florida Supreme Court Overturns Medical Malpractice Caps

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Florida’s Supreme Court ruled 5-to-2 in favor of invalidating medical malpractice caps on non-economic damages. The initial legislation was put into place in 2003 by the Florida Legislature due to an alleged medical malpractice crisis. The caps limited payments to patients for non-economic damages at $500,000 in most malpractice cases and $1 million in cases involving deaths. However, on March 13, 2014, the Supreme Court concluded that the cap on wrongful death non-economic damages violates the state Constitution’s equal protection clause.

This decision by Florida’s highest court makes Florida the seventh state to make such a ruling that such limitations are unconstitutional. There are 35 states that currently have some type of cap on medical malpractice awards.

This decision stirs up harsh criticism from doctors, and praise from trial attorneys.

History of the Caps on Medical Malpractice Lawsuits.

The damages caps were initiated in 2003 by former Governor Jeb Bush, backed by doctors, hospitals and insurance companies. Supporters argued that reforms were needed to curb the outbreak of medical malpractice costs. The caps were also initiated in an effort to lower the cost of malpractice insurance rates and to keep doctors from moving out of the state. According to Health News Florida with the caps, the number of medical malpractice lawsuits fell, which was interpreted as a sign that the caps discouraged trivial lawsuits. To read the entire article from Health News Florida, click here.

Harsh Words from Florida Medical Association.

The Florida Medical Association (FMA) President Alan Harmon, M.D., wasted no time in releasing a statement of discontent. In a press release Dr. Harmon stated, “The FMA is extremely disappointed in the Supreme Court’s decision. This decision imperils our considerable efforts to make Florida the best state in the nation for physicians to practice medicine and for patients to receive care.”

Dr. Harmon mentions that without caps to help regulate out-of-control litigation, many physicians may move out of the state, and few out-of-state physicians will look to locate to Florida.

To read the full press release from Dr. Harmon, click here.

What This Means for Health Care Professionals.

Now that medical malpractice caps are gone, trial lawyers will be refocusing on lawsuits. Health care professionals need to carefully evaluate each patient before treatment begins, even consulting with specialists when necessary. Detailed documentation is also important. Make sure everything is properly charted in the patient’s medical record. As a health care professional, its important to have an open line of communication with your patient, so that he or she knows and understands his or her medical treatment.

Get Professional Liability Insurance Now.

It is now more important than ever to have good professional liability insurance. The truth of the matter is that all health care professionals should protect themselves by obtaining a personal professional liability insurance policy. A good policy will provide medical malpractice and, very importantly, licensure protection coverage. The cost on these policies varies, but it is generally quite affordable, often costing little more that $10 to $15 a month. If you do not already have it, call Healthcare Providers Service Organization (HPSO), Lloyd’s of London, CPH & Associates Insurance, or another insurance company to discuss obtaining professional liability insurance.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

Our firm regularly represents physicians, dentists, nurse practitioners, pharmacists, massage therapists, mental health counselors, registered nurses (RNs), assisted living facilities (ALFs), home health agencies (HHAs), nurse practitioners, lab technicians, occupational therapists, physical therapists (PTs), social workers, physician assistants, psychologists and other health professionals in many different legal matters.
Services we provide include representation before your professional board in Department of Health investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care provider, how do you feel about the malpractice caps being thrown out? Will it make you think twice about taking certain cases or treating certain patients? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Malpractice Caps Thrown Out.” Health News Florida. (March 14, 2014). From: http://health.wusf.usf.edu/post/fl-malpractice-caps-thrown-out

Klas, Mary Ellen. “Florida Supreme Court Tosses Out Medical Malpractice Cap on Damages.” Tampa Bay Times. (March 13, 2014). From: http://www.tampabay.com/news/politics/florida-supreme-court-tosses-out-medical-malpractice-cap-on-damages/2170030

VanSickle, Erin. “Supreme Court Invalidates Medical Liability Caps.” Florida Medical Association. (March 13, 2014). From: http://www.flmedical.org/Supreme_Court_invalidates_caps.aspx

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

The Ins and Outs of Florida’s 2015 Legislative Session for Health Care Providers

George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in the Legal Specialty of Health Law

Committees are busy in Tallahassee as the 2015 Legislative Session is set to begin on March 3, 2015. For Florida physicians and other health care providers, now is the time to review the legislative bills that could affect you and your practice. There are many bills pending that could impact the future of medical practice and health care delivery in Florida.

On the table are some recognizable bills from last year, as well as a few new ones. To stay up to date on the 2015 Legislative Session as it relates to health care, check this blog regularly.

Bills Up for Consideration.

The two most profiled issues from the 2014 Legislative Session are back.

– House Bill (HB) 547 and the companion Senate bill (SB) 614 would give nurse practitioners the ability to prescribe controlled substances. It would also expand their scope of practice, which would exempt them from the requirement that certain medical acts be performed or supervised by a physician. To learn more on this bill, click here for our previous blog.

– HB 545 and the companion Senate bill SB 478 defines what is determined to be telemedicine or telehealth. These bills call for coverage in Medicaid programs. Lawmakers state an agreement has been made to require health care providers to be licensed in Florida to provide telemedicine in the state. House and Senate leaders have expressed confidence they will reach an agreement this year on telemedicine. Click here to learn more on telemedicine in Florida.

Each bill could dramatically change the landscape of the practice of Florida medicine.

Keep an Eye on These Additional Bills.

Other pending bills that could impact the delivery of health care in Florida, include:

– SB 516 addresses insurance coverage and reimbursement issues for emergency services;

– HB 279 would allow pharmacy interns to administer vaccinations to adults;

– HB 281 and SB 532 would allow licensed physician assistants under physician supervision to order controlled substances in the hospital setting; and

– HB 515 and SB 710 revise the scope of physical therapists and prohibit individuals with doctorates in physical therapy to present themselves as a doctor without informing the public of his or her actual profession as a physical therapist.

In Conclusion.

The 2015 Legislative Session is packed with bills that, if approved, will affect physicians, physician assistants, nurses, and other health care providers. As a health care provider, knowing the ins and outs of these bills can save you from the headache and possible fines that could come from non-compliance. We urge you to become involved with these issues. If you would like to know more, you can contact your local medical society. Again, we will stay on top of the progress of these bills, so check this blog regularly.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, pharmacists, pharmacies, optometrists, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, HIPAA complaints and violations, NPDB actions, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Stone, Rick. “PAs, Nurse Practitioners Could Get Prescribing Authority.” Health News Florida. (February 11, 2015). From: http://health.wusf.usf.edu/post/pas-nurse-practitioners-could-get-prescribing-authority?utm_source=Health+News+Florida+eAlert+subscriber+list&utm_campaign=e231ee3f8a-Friday_February_13_20152_13_2015&utm_medium=email&utm_term=0_8d22eaa6f6-e231ee3f8a-249582973

Saunders, Jim. “Telemedicine Deal Likely in 2015, Legislators Say.” Orlando Sentinel. (February 3, 2014). From: http://www.orlandosentinel.com/news/politics/os-florida-telemedicine-deal-20150203-story.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1999-2015 The Health Law Firm. All rights reserved.

New Recreational Marijuana Amendment Being Pushed in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

There is a new effort to legalize the use of marijuana for adults in Florida and not just for medical purposes. The two groups, The Florida Cannabis Action Network and Floridians For Freedom, are pushing for a new recreational marijuana amendment in Florida. Petitions will soon hit the streets for a proposed constitutional amendment that would completely legalize use, possession and cultivation of marijuana by Florida adults.

Getting on the 2016 Ballot.

The Florida Cannabis Action Network, along with a committee called Floridians For Freedom, stated that it had received state approval to begin seeking signatures which would get their measure on the ballot in November 2016. This measure is distinct from a previous amendment led by Orlando Lawyer John Morgan, who wanted to legalize marijuana for medical purposes only.

Floridians For Freedom will have to gather more than 67,000 valid signatures to get the effort to the next phase which is Florida Supreme Court review. Then the group will have to gather an additional 600,000 valid signatures to get it qualified for the ballot next fall. To visit their website, click here.

“Ending Prohibition” of Marijuana Under State Law.

According to Jodi James, chair of Floridians For Freedom and executive director of the Florida Cannabis Action Network, the commercial aspects of marijuana would be controlled by rules and regulations set by the Florida Legislature and Department of Commerce. “We want it to be legal. We want it to be regulated. We want it controlled. We want people to have safe access,” James said.

The Florida Cannabis Action Network currently has 20,000 members that it will call on to help collect valid signatures. To read one of our previous blogs on marijuana policy, click here.

Be sure to check The Health Law Firm’s Medical Marijuana Law Blog regularly to stay updated on this hot topic.

Comments?

What are your thoughts on making marijuana completely legalized? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys for Medical Marijuana Concerns.

The Health Law Firm attorneys can assist health care providers and facilities, such as doctors, pharmacists and pharmacies, wanting to participate in the medical marijuana industry. We can properly draft and complete the applications for registration, permitting and/or licensing, while complying with Florida law. We can also represent doctors, pharmacies and pharmacists facing proceedings brought by state regulators or agencies.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Source:

Powers, Scott. “Group to push amendment that would completely legalize marijuana.” Orlando Sentinel. (September 2, 2015). Print.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Legalize marijuana, Florida medical marijuana, medical cannabis, medical marijuana, medical marijuana lawyer, medical marijuana license, defense attorney, defense lawyer, health lawyer, marijuana, recreational cannabis, recreational marijuana, marijuana cultivation, Floridians For Freedom, Florida, Cannabis Action Network, commercial use of marijuana, Florida Legislature, Department of Commerce, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law firm. All rights reserved.

By The Health Law Firm|2015-09-11T21:15:03-04:00June 1, 2018|Categories: In the News, The Health Law Firm Blog|Tags: florida, Florida legislature, Legalize marijuana, the health law firm|0 Comments

Group Pushing For New Marijuana Legalization Amendment in Florida

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

There is a new effort to legalize the use of marijuana in Florida and not just for medical purposes. Petitions will soon hit the streets for a proposed constitutional amendment that would completely legalize use, possession and cultivation of marijuana by Florida adults.

Getting the Measure on the November 2016 Ballot.

The Florida Cannabis Action Network, along with a committee called Floridians For Freedom, stated that it had received state approval to begin seeking signatures which would get their measure on the November 2016 ballot. This measure is distinct from a previous amendment led by Orlando Lawyer John Morgan, who wanted to legalize marijuana for medical purposes only.

Floridians For Freedom will have to gather about 67,000 valid signatures to get the effort to the next phase which is Florida Supreme Court review. Then the group will have to gather an additional 600,000 valid signatures to get it qualified for the ballot next fall. To visit their website, click here.

“Ending Prohibition” of Marijuana Under State Law.

According to Jodi James, chair of Floridians For Freedom and executive director of the Florida Cannabis Action Network, all the commercial aspects of marijuana would be controlled by rules and regulations set by the Florida Legislature and Department of Commerce. “We want it to be legal. We want it to be regulated. We want it controlled. We want people to have safe access,” James said.

The Florida Cannabis Action Network currently has 20,000 members that it will call on to help collect valid signatures. To read one of our previous blogs on marijuana policy, click here.

Comments?

What are your thoughts on making marijuana completely legalized? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys for Medical Marijuana Concerns.

The Health Law Firm attorneys can assist health care providers and facilities, such as doctors, pharmacists and pharmacies, wanting to participate in the medical marijuana industry. We can properly draft and complete the applications for registration, permitting and/or licensing, while complying with Florida law. We can also represent doctors, pharmacies and pharmacists facing proceedings brought by state regulators or agencies.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Source:

Powers, Scott. “Group to push amendment that would completely legalize marijuana.” Orlando Sentinel. (September 2, 2015). Print.
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Legalize marijuana, Florida medical marijuana, medical cannabis, medical marijuana, medical marijuana lawyer, medical marijuana license, defense attorney, defense lawyer, health lawyer, marijuana, recreational cannabis, recreational marijuana, marijuana cultivation, Floridians For Freedom, Florida, Cannabis Action Network, commercial use of marijuana, Florida Legislature, Department of Commerce, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

By Lance O. Leider, J.D., The Health Law Firm

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida and nationally, we expect the bill to pass.

Click here to read the entire bill.

Requirements Under the New Bill.

The bill requires out-of-state compounding pharmacies to hold a compounded sterile product permit to ship medications into Florida. Applications for the permit would be provided by the Board of Pharmacy. The bill also requires pharmacies to meet or exceed Florida’s sterile compounding standards. Under the bill, the Florida Department of Health (DOH) is responsible for inspecting out-of-state compounding pharmacies for compliance. The DOH would hold the authority to punish or revoke an out-of-state compounding pharmacy’s license for noncompliance. The pharmacy would be responsible for reimbursing the cost of the inspection.

If the bill passes, compounding pharmacies already shipping compounded sterile products into Florida may continue to do so, as long as the pharmacy receives a permit before January 31, 2015.

Permit Law for Florida Pharmacies that Compound Sterile Products.

Similarly, the Florida Board of Pharmacy promulgated a rule requiring a permit for pharmacies that compound sterile products in Florida. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit.

Click here to read more on this permit.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and U.S. Food and Drug Administration (FDA), track pharmacies compounding sterile products.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the bill to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Sources:

The News Service of Florida. “Pharmacy Bill, FL Budge Taking Shape.” WUSF News. (March 14, 2014). From: http://wusfnews.wusf.usf.edu/post/pharmacy-bill-fl-budget-taking-shape

Palombo, Jessica. “After Federal Compounding Pharmacy Crackdown, Fla. Panel Passes Extra Restrictions.” WFSU News. (February 12, 2014). From: http://news.wfsu.org/post/after-federal-compounding-pharmacy-crackdown-fla-panel-passes-extra-restrictions

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices

According to the Florida Legislature, it’s time for pharmacists to focus on their patients instead of paperwork. On June 13, 2014, Florida Governor Rick Scott signed Florida Senate Bill 702 into law. This law introduces clear guidelines of acceptable audit practices of pharmacies in the Sunshine State.

There are more than 2,700 pharmacies across Florida that are routinely evaluated by Pharmacy Benefit Managers (PBMs). The purpose of these audits is to verify that certain claims are submitted and handled properly. If a PBM audit uncovers fraud or abuse, the pharmacy will be subject to penalties, including reimbursement of amounts paid. With the increase of rules regulating pharmacies, these audits have progressively become more time consuming for pharmacists.

Florida SB 702 becomes effective on October 1, 2014. To read a summary of the law, click here.

What’s the Need of the New Law?

In the United States, a PBM is most often a third party administrator of prescription drug programs. The PBM is primarily responsible for processing and paying prescription drug claims.
Currently, PBMs have broad discretion to penalize pharmacies. This means that pharmacies can be forced to pay thousands of dollars as the result of basic clerical or typographical mistakes, many of which are not the fault of the pharmacist or pharmacy staff. This law was enacted to provide reasonable standards for pharmacy audits while allowing PBMs to continue penalizing for true fraud and abuse.

Pharmacy Rights Included in New Law.

SB 702 makes common-sense auditing standards that include:

–   At least seven days advance notice before an on-site audit is conducted;
–   On-site audits scheduled after the first three days of the month;
–   A limit on the audit period of 24 months after the date claim is submitted;
–   Audits requiring clinical judgment must be conducted by or with a pharmacist;
–   Use of written practitioner records to validate pharmacy records in accordance with state and federal law;
–   Reimbursement of claims retroactively denied for clerical, typographical or computer errors unless pharmacy has a pattern of fraudulent billing;
–   Delivery of initial audit reports to pharmacists within 120 days after an audit is completed;
–   Receipt of final audit report within six months of the preliminary report;
–   Allowing 10 days for pharmacists to provide documentation to address any discrepancies found during an audit;
–   Prohibiting the use of extrapolations in auditing claims; and
–   The Office of Insurance Regulation will study pharmacy complaints of willful violations of audit provisions by PBMs.

Stipulation of Rights.

The rights listed above do not apply to audits that are based on suspicions of fraud or willful misrepresentation; audits of claims paid for by federally funded programs; or concurrent reviews or desk audits that occur within three business days after transmission where no chargeback or recoupment is demanded.

An entity that audits a pharmacy located within a Health Care Fraud Prevention and Enforcement Action Team Task Force area designated by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) is not required to provide seven days prior notice of an audit if the pharmacy has been a member of a credentialed provider network for less than 12 months.

What This Means for You.

For once there is a new law that does not make a pharmacist’s job more complicated. This law may actually alleviate some of the stress that comes with dealing with an audit. We’re hoping with the implementation of this law pharmacists will be able to spend more time focusing on patient care.

Comments?

What do you think of this new law? Will it affect your pharmacy? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

By The Health Law Firm|2014-07-07T09:00:44-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Florida Legislature, Pharmacist, Pharmacy, Pharmacy Audit, Pharmacy Law|Tags: defense attorney, defense lawyer, Florida governor, Florida legislature, Florida pharmacy, health law firm, House Bill 745, pharmacist, pharmacist attorney, pharmacist lawyer, pharmacy, pharmacy audit, pharmacy benefit manager, pharmacy evaluation, Rick Scott, Senate Bill 702, the health law firm|0 Comments

Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014.
The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent another nationwide outbreak of fungal meningitis, similar efforts to tighten control on compounding pharmacies have been implemented by other states across the country. Click here to read a prior blog on the fungal meningitis outbreak.

The Lowdown on the New Law.

The bill requires an out-of-state compounding pharmacy or an outsourcing facility to obtain a nonresident sterile compounding permit before shipping products into Florida. Any currently-registered nonresident pharmacies must be permitted by February 28, 2015. However, all compounded sterile products shipped, mailed, delivered, or dispensed into the Sunshine State must meet Florida’s standards for sterile compounding.

The law establishes application and inspection requirements for the nonresident sterile compounding permit, as well as increased responsibilities for the Florida DOH and the Board of Pharmacy.

Under the law, the Florida DOH and Board of Pharmacy are given enhanced oversight for these out-of-state compounding pharmacies, including the authority to inspect a pharmacy or sterile compounding permittee; the cost of which is picked up by the pharmacy or permittee. The Board is authorized to discipline a nonresident pharmacy for conduct which causes or could cause serious injury, without waiting 180 days for the resident state to act. The Board is also authorized to discipline nonresident pharmacies and sterile compounding permittees for specified acts of noncompliance.

New Standards Triggered by Tainted Compounded Medications.

These new standards are being implemented two years after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. To read more: click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and the Board of Pharmacy, track pharmacies compounding sterile products.

Comments?

What do you think of the law to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Shedden, Mary. “Tougher Compounding Rules Finally Law.” Health News Florida. (September 30, 2014). From: http://bit.ly/1xBQtS0

Florida House Bill 7077

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.