Compliance Update

What’s All This Talk About 340B Discount Drug Programs?

There has been so much in the news lately about 340B Discount Drug Programs and the fraud that accompanies them. The 340B Discount Drug Program allows manufacturers participating in Medicaid to agree to provide outpatient drugs to certain designated clinics and hospitals at significantly reduced prices. The typical discount ranges from 30% to 50% off the drug’s list price. In turn those...

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Teva Charged With Paying Kickbacks to Increase Sales of MS Drug

Teva Pharmaceuticals has joined a growing list of healthcare organizations alleged to have used charitable foundations to pay hundreds of millions of dollars in kickbacks. Earlier this month, the U.S. Attorney’s Office in Boston filed a complaint against Teva Pharmaceuticals USA, Inc. and Teva Neuroscience, Inc., the maker of Copaxone. It alleged the company conspired with a specialty pharmacy...

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The ethical case for allowing medical trials that deliberately infect humans with COVID-19

Could intentionally infecting volunteers in COVID-19 trials speed up a vaccine?  AP Photo/Ted S. Warren   Despite the urgent need to beat COVID-19, health officials may be delaying the development of an effective vaccine. Authorities in the U.S. and elsewhere are yet to authorize an ethically charged research procedure called “human challenge trials.” Challenge trials entail deliberately...

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The Top 5 Legal Concerns When Developing a Healthcare App

Today no one can live without a smart phone, and we interact with the rest of the world through a series of apps that reside on our handheld devices. From the healthcare perspective many large healthcare institutions and private companies have developed a myriad of healthcare related apps that currently reside in Apple’s App Store and  Google's Play Store. You can measure your heart rate, get...

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Failure to Abide by Corporate Integrity Agreement Can Trigger Additional Woes

On June 1, the Departmental Appeals Board (DAB) voted to uphold an order issued by the Department of Health and Human Services Office of the Inspector General (HHS-OIG) against a group of Tennessee-based home health companies to pay $1,322,500 in stipulated penalties for breaches of their Corporate Integrity Agreement (CIA). OIG negotiates Corporate Integrity Agreements as part of settlements...

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A Real Alternative to Laying Off Employees, Try Independent Contracting? First Understand the IRS’s 20 Factor Test

The pendulum from employee to independent contractor has started to swing. As Covid-19 plays out in the economy, department heads of healthcare organizations are being asked to cut their budgets.  Employers are unsure of demand and how to pay for employee salaries, payroll taxes and benefits. If there is not enough work to keep an employee working, employers are looking at independent...

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