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Walgreens Agrees to Pay $7.5 Million To End Lawsuit Over Unlicensed Pharmacist

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On February 4, 2020, Walgreens agreed to pay $7.5 million to settle allegations that for more than a decade it let an unlicensed pharmacist handle hundreds of thousands of prescriptions. The pharmacy giant settled with authorities after an employee was criminally charged with impersonating a pharmacist in California. Prosecutors said that from 2006 through 2017, she used the license numbers of other registered pharmacists to dispense more than 745,000 prescriptions at Walgreens stores.

A Phony Pharmacist.

According to the lawsuit, Kim Thien Le worked for Walgreens for more than 15 years, first as an intern and then a pharmacist, despite never having her license. Le allegedly used the license of another person with the same first name to dispense more than 100,000 […]

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Florida’s New E-Prescribing Law: How It May Affect You and Your Career

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
In 2019, Florida’s Governor Ron DeSantis signed House Bill 831 (2019), Electronic Prescribing, into law. The new bill provides important requirements for prescribers to generate and transmit all prescriptions electronically upon their license renewal or by July 1, 2021, whichever is earlier. The bill will go into effect on January 1, 2020.

Summary of New Law, HB 831.

The new law applies to any health care practitioner who is licensed by law to prescribe a medicinal drug. The law, HB 831 sets forth the following general rule for prescribing:

If you are licensed to prescribe a medicinal drug, and you:

(1) Maintain a system of electronic health records; or

(2) Are an owner, employee or contractor of a licensed healthcare facility […]

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Common Errors We See in Pharmacy Inspections and How to Avoid Them

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law and Carole C. Schriefer, R.N., J.D., The Health Law Firm

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and the Department of Health (DOH), have the authority to inspect pharmacies.

Inspections may be routine and simply to confirm compliance with the law. Annual inspections by the Florida DOH are examples of these. However, inspections can also be triggered by a fear of imminent danger to the public health, safety, and welfare; a formal complaint; or the belief that a specific violation of law by the pharmacy or pharmacist […]

By The Health Law Firm|2024-03-14T10:00:09-04:00October 8, 2019|Categories: Pharmacy Law Blog|Tags: administrative law representation, common deficiencies in pharmacy inspection, DEA investigation lawyer, DEA pharmacy investigation attorney, Department of Health (DOH) representation DOH defense lawyer, DOH inspections, DOH investigators, FDA investigation lawyer, FDA pharmacy investigation representation, Florida Board of Pharmacy lawyer, Florida defense attorney, Florida defense lawyer, Food and Drug Administration (FDA) representation, health law defense attorney, legal defense for administrative complaints, pharmacy defense lawyer, pharmacy law defense attorney, representation for Board of Pharmacy inspections, representation for Drug Enforcement Administration (DEA), representation for pharmacies, representation for pharmacy inspections, reviews of The Health Law Firm, The Health Law reviews|Comments Off

Walgreens Agrees to Pay $269 Million to Settle Two FCA Suits

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

On January 22, 2019, Walgreens agreed to pay more than $269 million to settle allegations of False Claims Act (FCA) violations for overbilling of various drugs. The deals are some of the largest pay-outs ever by a retail pharmacy, according to the United States Department of Justice (DOJ).

The Two Settlements.

There were two separate complaints involving Walgreens to settle federal and state lawsuits that accused the pharmacy of overbilling federal healthcare programs. Both were unsealed by U.S. District Court judges in Manhattan, according to the DOJ.

In the first settlement, Walgreens agreed to pay $209.2 million to the U.S. and several state governments for improperly billing Medicare, Medicaid and other federal healthcare programs. The pharmacy […]

FDA Releases Draft Guidance to Revamp Drug Indication and Usage Labels

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

On July 6, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance outlining its recommendations for how drug companies should word the indications and usage sections on a drug’s label. The new guidance aims to increase readability and reduce redundant information on indications and usage.

Drug Indication Label.

Prescribers can expect to see revamped drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated. Also, described in the guidance are circumstances when it might be appropriate for an indication to be either broader or narrower than the parameters of the clinical studies that backed its approval.

In addition to suggesting what information labels should include, […]

By The Health Law Firm|2024-03-14T10:00:24-04:00July 12, 2018|Categories: The Health Law Firm Blog|Tags: Food and Drug Administration (FDA) defense attorney, health care compliance lawyer, health law defense attorney, legal representation for health care professionals, legal representation for pharmacies, legal representation for pharmacists, pharmacist defense attorney, pharmacist representation, pharmacy defense lawyer, pharmacy representation, representation for FDA matters, representation for prescribers, reviews of The Health Law Firm attorneys, The Health Law Firm reviews|Comments Off

Kmart Agrees to Pay $32.3 million to Settle Whistle Blower’s False Claims Act Suit

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

On December 22, 2017, Kmart Corporation agreed to pay $32.3 million to settle a whistle blower lawsuit alleging its pharmacies caused federal health programs to overpay for prescription drugs by not telling the government about discounted prices. The department store chain withheld certain information from Medicare Part D, Medicaid and Tricare, the Department of Justice (DOJ) said.

The Whistle Blower False Claims Act (FCA) Suit.

The new agreement resolves allegations arising from a 2008 lawsuit brought under the qui tam, or whistle blower, provisions of the False Claims Act (FCA). This provision permits private citizens with knowledge of fraud against the government to bring an action on behalf of the United States and to share in any recovery.

The 2008 lawsuit, which was filed by a […]

Kmart Agrees to Pay $32.3 million to Settle Whistle Blower’s False Claims Act Suit

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

On December 22, 2017, Kmart Corporation agreed to pay $32.3 million to settle a whistle blower lawsuit alleging its pharmacies caused federal health programs to overpay for prescription drugs by not telling the government about discounted prices. The department store chain withheld certain information from Medicare Part D, Medicaid and Tricare, the Department of Justice (DOJ) said.

The Whistle Blower False Claims Act (FCA) Suit.

The new agreement resolves allegations arising from a 2008 lawsuit brought under the qui tam, or whistle blower, provisions of the False Claims Act (FCA). This provision permits private citizens with knowledge of fraud against the government to bring an action on behalf of the United States and to share in any recovery.

The 2008 lawsuit, which was filed by a […]

Kmart Agrees to Pay $32.3 million to Settle Whistle Blower’s False Claims Act Suit

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

On December 22, 2017, Kmart Corporation agreed to pay $32.3 million to settle a whistle blower lawsuit alleging its pharmacies caused federal health programs to overpay for prescription drugs by not telling the government about discounted prices. The department store chain withheld certain information from Medicare Part D, Medicaid and Tricare, the Department of Justice (DOJ) said.

The Whistle Blower False Claims Act (FCA) Suit.

The new agreement resolves allegations arising from a 2008 lawsuit brought under the qui tam, or whistle blower, provisions of the False Claims Act (FCA). This provision permits private citizens with knowledge of fraud against the government to bring an action on behalf of the United States and to share in any recovery.

The 2008 lawsuit, which was filed by a […]