Pharmacy Law | The Health Law Firm Blog

Florida Pharmacy Owner to Serve 15 Years in Prison for $100 Million Billing Fraud Scheme

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

On April 26, 2018, the owner of several Florida pharmacies was sentenced to 15 years in prison and ordered to give up $54.5 million in restitution. Nicholas A. Borgesano Jr., owner of A to Z Pharmacies, pled guilty to his role in a $100 million scheme involving bogus insurance reimbursements for prescription drugs.

He pled guilty in November to charges of conspiracy to commit health care fraud and conspiracy to engage in monetary transactions in property derived from specified unlawful […]

By The Health Law Firm|2024-03-14T10:00:24-04:00June 26, 2018|Legal Defense for Pharmacists, Pharmacist, Pharmacy Law, Pharmacy Law Blog, Uncategorized|

Jury Awards Walgreens Customer $1.44 Million Over HIPAA Violation

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

An Indiana jury awarded a Walgreens customer $1.44 million on July 26, 2013, over a Health Insurance Portability and Accountability Act (HIPAA) violation, according to the Indianapolis Star. The Walgreens pharmacist was found to have violated the customer’s privacy by looking up and sharing the customer’s prescription history with others. The lawsuit alleged that there was a relationship between the pharmacist, her husband and the husband’s ex-girlfriend (who was the customer). The customer/ex-girlfriend was the plaintiff in the lawsuit.

Click here to read […]

By The Health Law Firm|2024-03-14T10:01:14-04:00May 15, 2018|Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|

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

By 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 […]

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

New Permit Law for Florida Pharmacies that Compound Sterile Products

Lance O. Leider, J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Board of Pharmacy announced a new law which will be required for pharmacies that compound sterile products. 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. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014.

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By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

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

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama […]

By The Health Law Firm|2024-03-14T10:01:15-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy Law|

Florida Board of Pharmacy Updates Record Retention Rules for Pharmacies

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

At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records.

Previously the Board’s rules were not consistent with respect to how long pharmacies were required to retain different types of records.

When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies […]

By The Health Law Firm|2024-03-14T10:01:16-04:00May 15, 2018|Florida Board of Pharmacy, Pharmacist, Pharmacy, Pharmacy Law|

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 […]

By The Health Law Firm|2024-03-14T10:01:16-04:00May 15, 2018|Compounding pharmacy, Florida Board of Pharmacy, Pharmacy, Pharmacy Law|

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 […]

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

OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

By Lenis L. Archer, J.D., M.P.H., The Health Law Firm

There is an inherent risk in entering into financial arrangements where payments to a service provider are only made when a referral is generated. On August 15, 2014, the Office of Inspector General (OIG) made this perfectly clear in an unfavorable advisory opinion issued to a specialty pharmacy that wanted to pay local retail pharmacies for providing support services to it.

Background of Request for OIG Advisory Opinion.

According to the OIG, the requestor, a specialty pharmacy, dispenses specialty pharmaceuticals used to treat a variety of chronic and life-threatening illnesses. The specialty pharmacy stated that the drugs offered at its establishment are […]

By The Health Law Firm|2024-03-14T10:01:17-04:00May 15, 2018|Pharmacist, Pharmacy, Pharmacy Law|

Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

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

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end […]

By The Health Law Firm|2024-03-14T10:01:19-04:00May 15, 2018|Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacy Audit, Pharmacy Law|