Florida HB 0653 Signed Into Law; Effective 2/1/2012

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

The Florida Legislature unanimously passed HB 653 which relaxes some of the draconian exclusions enacted under SB 1986, which went into effect on July 1, 2009. SB 1986, which added provisions to Chapter 456, Florida Statutes, among others, prevented numerous healthcare providers from obtaining or renewing licenses based on prior criminal convictions, which could have occurred decades earlier.

HB 653 has been passed unanimously by the Florida Legislature and has been signed by the Governor to be effective July 1, 2012. It has been signed into law as Chapter 2012-64, Florida Laws and amends Section 456.0635(5), Florida Statutes (2012).

Under HB 653, the professional boards within the Department of Health (such as the Board of Medicine, Board of Nursing, Board of Psychology, Board of Massage Therapy, etc.) now will, if signed by the Governor, only prohibit the renewal or granting of a health professional’s license, certificate or registration, if the individual:

1. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under Chapters 409 (Medicaid offenses), 817 (theft or fraud) or 893 (drug offenses), Florida Statutes, or similar laws in other jurisdictions, unless the individual successfully completed a drug court program for the felony and provides proof that the plea was withdrawn or the charges were dismissed, or unless the sentence and any related period of probation for such conviction or plea ended:

– For first and second degree felonies, more than fifteen (15) years before the date of application;

– For third degree felonies, more than ten (10) years before the date of application, except for third degree felonies under Section 893.13(6)(a), Florida Statutes; and

– For third degree felonies under Section 893.13(6)(a), Florida Statutes, more than five (5) years before the date of application.

2. Has been convicted of, or entered a plea of guilty or no contest to, regardless of adjudication, a felony under 21 U.S.C. Sections 801-970 or 42 U.S.C. Sections 1395-1396 (federal Medicare & Medicaid offenses), unless the sentence and any subsequent period of probation for such convictions or plea ended more than fifteen (15) years before the date of application; or

3. Is listed on the OIG’s list of excluded individuals and entities.

This new legislation has the effect of reducing the period of time a health professional may be prohibited from holding a license because of a conviction for one of the enumerated felonies. Under the current law, there is a fifteen (15) year prohibition for all enumerated offenses. The new legislation, if signed, will reduce the period to as little as five (5) years for drug offenses.

However, it also broadens the reach of the current Florida law by including, for the first time, convictions under “similar laws in other jurisdictions.” This may now “catch” many to whom the Florida law did not previously apply.

HB 653 also allows individuals previously denied renewals under SB 1986 who at are now eligible for renewal to obtain a license without retaking and passing their examinations.

The latter requirement above, number 3, may present a “catch 22” for many health professionals. Usually, if a licensed health professional is convicted of a felony, loses his/her license or is denied renewal of a health professional’s license, this is reported to the National Practitioner Data Bank (NPDB). The NPDB now includes reports previously made to the Healthcare Integrity and Protection Data Bank (HIPDB). If this occurs, in most cases the Office of Inspector General (OIG) commences action to exclude the professional from the Medicare Program. This automatically places the health provider’s name on the OIG’s List of Excluded Individuals and Entities (LEIE). Therefore, most licensed health professionals, even if they are no longer prohibited from holding a license under numbers 1 and 2 above, may still be prohibited because of requirement number 3 above.

Doubtless, this lacuna (gap) in this legislation will require additional corrective legislation in the future.

To view a summary of HB 653, click here.

To view the Bill Analysis of HB 653 from the Health and Human Services Quality Subcommittee, click here.

To view the Bill Analysis of HB 653 from the Health Care Appropriations Subcommittee, click here.

To view the Bill Analysis of HB 653 from the Health and Human Services Committee, click here.

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.

Florida Nurse Practitioners Fight for Autonomy

indest1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On February 18, 2014, a bill that would expand the authority of nurse practitioners and would allow some to practice independently of physicians was approved by the Florida House Select Committee on Health Care Workforce Innovations. Despite opposition from physician groups, the bill (PCB SCHCWI 14-01) was overwhelmingly approved 13 to 2. However, some of that support might be fleeting.

To read bill PCB SCHCWI 14-01, click here.

Details of the Bill.

Currently, nurse practitioners work under the supervision of physicians. This bill would change the title of what are usually called nurse practitioners, which are registered nurses who have post-college education, usually a master’s degree, to Advanced Practice Registered Nurses (APRNs). The bill would also apply to specialists, such as certified registered nurse anesthetists (CRNAs), certified nurse midwives and certified nurse practitioners.

These nurses would gain new powers under the bill, such as the ability to sign documents that now require a physician’s signature, and the opportunity to earn the title “Independent Advance Practice Registered Nurse” after a certain amount of training and experience. Nurse practitioners would no longer have to contract with and pay a “supervising” physician. Another controversial aspect of the bill is to allow these nurses to gain the authority to prescribe controlled substances. Currently, Florida is one of the few states that do not allow this.

Supporters and Opponents Cannot Agree.

Even though the vote drew bipartisan support, several committee members said their support was tentative, and that they wanted to see further debate and amendments.

According to Health News Florida, the President of the Florida Senate reported he opposes the House bill. Many physician groups, including the Florida Medical Association, agree. These groups point out that physicians receive years of additional training to provide care. They also raise the question why students would want to rack up huge amounts of debt to attend medical school if they could do much of the same work as nurse practitioners with less schooling.

Supporters state this bill will help increase access to primary care, particularly in rural areas. Nurse practitioners also state they already provide much of the care that physician groups bill for. It’s argued that similar laws are already in place in a majority of states around the country, according to The News Service of Florida. To read the entire article from The News Service of Florida, click here.

Expanded Scope of Practice for Nurse Practitioners Already Working in Other States.

According to Health News Florida, 23 other states already allow independent practice for nurse practitioners. Also, military services and the Veterans Administration Health System, already allow nurse practitioners to prescribe controlled drugs and allow independent practice. Florida is the only state that prohibits nurse practitioners from prescribing controlled substances.

According to Health News Florida, the issue is not expected to be considered during the upcoming Legislative session. Click here to read the entire Health News Florida article.

Be sure to check this blog regularly for updates to this story.

Contact Health Law Attorneys Experienced in Representing Nurses.

The Health Law Firm’s attorneys routinely represent registered nurses, nurse practitioners, advanced registered nurse practitioners, certified registered nurse anesthetists, midwives and licensed practical nurses in Department of Health (DOH) investigations, in appearances before the Board of Nursing in licensing matters and in many other legal matters. We represent nurses across the U.S., and throughout Florida.

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 are your thoughts on the bill? Do you think nurse practitioners should have more autonomy? Or do you believe nurse practitioners should be supervised by physicians? Please leave any thoughtful comments below.

Sources:

Saunders, Jim. “Nurse Practitioners Win First Round In Fight Over ‘Scope.'” The News Service of Florida. (February 22, 2014). From: http://www.theledger.com/article/20140222/NEWS/140229772/1374?Title=Nurse-Practitioners-Win-First-Round-In-Fight-Over-8216-Scope

Gentry, Carol. “Senate Pres.: No On Nurses’ Bill.” Health News Florida. (February 24, 2014). From: http://health.wusf.usf.edu/post/senate-pres-no-nurses-bill

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.

Group Pushing For New Marijuana Legalization Amendment in Florida

Attorney George F. Indest III Headshot 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

Lance Leider headshotBy 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

1 Indest-2008-1According 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.

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