Pharmaceutical Company Brings Lawsuit in Florida to Stop Alleged 340B Fraud

gilead complaint november 2020

gilead complaint november 2020By: Jacqueline Bain

On November 3, 2020, Gilead Sciences Inc. filed suite in the Southern District of Florida Federal Court seeking damages from and injunctions against 58 defendants in South Florida for their part in an alleged scheme to defraud Gilead for millions of dollars. The defendants are comprised of medical clinics, laboratories, pharmacies and their owners, officers and employees.

Gilead is a pharmaceutical company that develops and manufactures drugs for the prevention and treatment of HIV, AIDS, hepatitis B and hepatitis C. Gilead has created a medication assistance program that provides eligible uninsured persons with free medication to help protect them from becoming infected with HIV. Gilead alleges that the defendants are exploiting the program’s charitable purpose for their own financial gain, endangering patients in the process.

The alleged scheme is complex and involves a lot of people participating in a wide-spread conspiracy, yet is exactly the type of convoluted scheme that regulators and insurance companies target. If the allegations are true, nearly 60 fraudulent operators will have to find another line of business. The OIG is likely to be following this very closely to determine if federal charges should follow.Continue reading

Pharmacists Authority To Give Vaccinations Expanded By HHS

pharmacists giving childhood vaccines

pharmacists giving childhood vaccinesBy: Zach Simpson

On August 19, an amendment to the Public Readiness and Emergency Preparedness Act was announced by HHS which allows pharmacists in every state to now administer childhood vaccinations to children ages 3 and older, subject to several requirements,

  • The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
  • The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.
  • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.

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Getting Back to a New Workplace Normal

By: Steven Boyne

As employers begin to consider opening their offices and bringing back their employees and inviting other people into their offices, such as patients, there are many issues that should be considered and planned for BEFORE the front door is opened.

Quick Legal Advice – COVID-19 is new to everyone, including Government regulators and plaintiff lawyers, so we are all learning as we go along. The best legal advice in these uncertain times is:

  1. Find out what other similar situated companies are doing, as you may be held to their standards;
  2. Find checklists and advice from well reputable entities;
  3. Document your decisions; and
  4. Communicate.

OPENING YOUR DOOR TO YOUR EMPLOYEES

As an employer you have a responsibility to provide a safe working environment, and as of today it is clear that the following is a minimal list of considerations:Continue reading

Coronavirus Call to Action

Corona virus call to action. Blog post by healthcare attorney David J. Davidson

Corona virus call to action. Blog post by healthcare attorney David J. Davidson By: David J. Davidson

On March 4, 2020, the Centers for Medicare & Medicaid Services (CMS) issued three Quality, Safety & Oversight Memoranda, all concerning the Coronavirus. According to these documents, effective immediately, the government will begin to focus its inspections exclusively on issues related to infection control and other serious health and safety threats. According to CMS Administrator Seema Verma, the memoranda should be seen as a “call to action across the healthcare system.” The goal of the guidance given in the memoranda is to continue to keep Americans safe and prevent the spread of the Coronavirus.

The first memorandum resets the focus of governmental surveys. The order of priority for government surveys will now be:

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