May 2018

Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices

By |2024-03-14T10:01:17-04:00May 15, 2018|Florida Board of Pharmacy, Florida Legislature, Pharmacist, Pharmacy, Pharmacy Audit, Pharmacy Law|

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 […]

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

By |2024-03-14T10:01:18-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Florida Legislature|

8 Indest-2008-5By 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 […]

Selling Tobacco Can Get You Penalized By Insurance Panels

By |2024-03-14T10:01:18-04:00May 15, 2018|Florida Board of Pharmacy, Insurance, Insurance Network Plan, Pharmacist, Pharmacy, Pharmacy Benefit Manager, Prescription-Drug Network|

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

Beware: selling cigarettes could burn a hole in your pocket.

The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of […]

CVS Blacklists Second Set of Doctors Accused of Overprescribing Painkillers

By |2024-03-14T10:01:40-04:00May 15, 2018|Pharmacist, Pharmacy|

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

CVS is again stepping up its own internal efforts to combat the nation’s prescription drug abuse epidemic. According to Reuters, the second largest retail pharmacy chain announced it is cutting off access to the most powerful painkillers for more than 36 doctors and health care providers around the country. The Drug Enforcement Administration (DEA) has been keeping a close eye on CVS over the past few years. According to Reuters, CVS began revoking the dispensing privileges of certain providers back in 2011. CVS disclosed this round of suspensions on August 21, 2013.

To read […]

Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule

By |2024-03-14T10:01:40-04:00May 15, 2018|Florida Board of Pharmacy, Pain Management, Pharmacy, Pharmacy Law|

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

At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies.

The focus of the new rule changes is to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the […]

DEA Offers New Prescription Drug Return Policy

By |2024-03-14T10:01:40-04:00May 15, 2018|Pain Management, Pharmacist, Pharmacy, Pharmacy Law|

3 Indest-2009-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address […]

Pharmacies May be Liable for Filling Valid Prescriptions

By |2024-03-14T10:01:41-04:00May 15, 2018|Florida Board of Pharmacy, Florida Legislature, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to […]

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

By |2024-03-14T10:01:13-04:00May 15, 2018|Compounding pharmacy, Department of Health, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid […]

Terrible Things That Can Happen after Discipline on Your Pharmacist License or Resignation of a Pharmacist License after Notice of Investigation

By |2024-03-14T10:01:13-04:00May 15, 2018|Florida Board of Pharmacy, Pharmacist, Pharmacy, Pharmacy Law|

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Do you have a pharmacist license in several different states? Do you have a license in more than one health profession? Have you been notified that an investigation has been opened against you? Are you thinking about resigning your pharmacist license or voluntarily relinquishing such a license? Then you must be aware of the following.

First, you should never voluntarily relinquish or resign your license after you know that an investigation has been opened or that disciplinary action has been taken against you. Such a resignation is considered to be a “disciplinary relinquishment” and is […]

Generic Drug Maker Ranbaxy Pleaded Guilty to Claims of Adulterated Drugs-Must Pay $500 Million Fine

By |2024-03-14T10:01:14-04:00May 15, 2018|Pharmacy, Pharmacy Law|

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Generic drug maker Ranbaxy USA Inc., pleaded guilty to drug safety violations and will be responsible for paying $500 million in criminal and civil fines, according to the Department of Justice (DOJ). The fines will resolve claims that the manufacturer sold inferior drugs and made false statements to the U.S. Food and Drug Administration (FDA) about manufacturing practices at two factories in India. This announcement was made by the DOJ on May 13, 2013. This settlement is the largest drug settlement to date involving a generic drug manufacturer and drug safety.

To read […]

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