Pharmacy Law

/Pharmacy Law

Client Alert – Members of Congress Call for Review of FDA Guidance on Compounding under Section 503A

June 27, 2017 - Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded [...]

Georgia Pharmacy Agrees to Settle False Claims Act Allegations for $2 Million

The Rhine Drug Company (Rhine) and its owner Carter Clements agreed last week to a settlement with the U.S. Attorney’s Office for the Southern District of Georgia to resolve allegations of violating the False Claims Act and Controlled Substance Act. Rhine and Clements will pay $2.175 million, making it the largest False Claims Act recovery [...]

Express Scripts Requiring Performance Bonds

June 15, 2017 Express Scripts is now requiring some applicants who wish to contract with them to furnish a $500,000 performance bond for at least the first two years of the contract. This bond, per Express Scripts, “guarantees to the obligee (Express Scripts) that the principal will carry out the performance of their contract according [...]

Electronic Health Record Software Vendor Set to Pay $155 Million to Settle False Claims Act Allegations

One of the nation’s largest vendors of health record software, eClinicalWorks (ECW), has agreed to pay the government $155 million to settle claims that it misrepresented the capabilities of its software to its nearly 850,000 subscribers and that it paid kickbacks to certain customers in exchange for promoting its product. The case, initially filed by [...]

Health Care Fraud is a Priority for the DOJ: Notes from the ABA’s Institute on Health Care Fraud

On May 18, 2017, Acting Assistant Attorney General Kenneth A. Blanco of the Criminal Division of the Department of Justice (DOJ) addressed attendees at the American Bar Association’s 27th Annual Institute on Health Care Fraud. Early in his speech, Blanco asserted Attorney General Jeff Session’s firm commitment to fighting health care fraud: … let me [...]

HHS Office of Inspector General Issues Annual Report on MFCU Activities

Trend lines show increasing Medicaid fraud convictions, settlements, and judgments The U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) recently released its Medicaid Fraud Control Units Fiscal Year 2016 Annual Report (“The Report”). The Report shows a distinct trend toward an increasing number of Medicaid fraud convictions, civil settlements, and judgments [...]

Continuity of Care, Patient Treatment Plans, and State & Federal Law?

Anthony Calamunci and Brian Dickerson were interviewed by RXinsider on the status of the Pharmacy industry.  Each week FisherBroyles will provide access to the industry specific Q&A interview sessions hosted by RXinsider so you can learn what the newest legal and industry issues are and how to address these issues when running your pharmacy.  Please [...]

Utah Pharmaceutical Wholesaler Faces up to 10 Years in Prison in Prescription Fraud Scheme

Originally indicted in late 2015, the owner of a Utah-based wholesale drug distribution company pled guilty to selling more than $100 million in black market prescription drugs. Randy Crowell, the owner and operator of Green Valley Medical Distributors LLC (Green Valley), faces up to 10 years in federal prison for his role in the scheme. [...]

Lab Giant Quest Diagnostics to Pay $6 Million to Settle Kickback Allegations

The U.S. Justice Department announced in a recent release that medical laboratory giant Quest Diagnostics (Quest) has agreed to pay $6 million to resolve kickback claims against one of its laboratories, Berkeley HeathLab (Berkeley) of Alameda, California. The claims against Berkeley arose in 2011 in a lawsuit initially filed by Dr. Michael Mayes under the [...]

Wireless Health Services Provider Agrees to $2.5 Million Settlement for HIPAA Disclosures

In a first-of-its-kind settlement for a wireless health care services provider, CardioNet, a Pennsylvania-based telemetry company, has agreed to pay $2.5 million to the U.S. Department of Health and Human Services (HHS) for a breach that led to the disclosure of the electronic protected health information (ePHI) of 1,391 individuals. CardioNet provides remote mobile monitoring [...]