Pharmaceuticals


New Medicare App to Explain Coverage
February 6, 2019 | Cassandra Rivais | Hospitals | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On January 28, the Centers for Medicare & Medicaid Services (CMS) announced the launch of a new mobile app called “What’s Covered” to help consumers understand which items and services are covered by Medicare. The app is part of the eMedicare Initiative, launched in October 2018 to modernize the delivery of information about the program. …
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FTC to Focus on Unsubstantiated Health Claims
January 30, 2019 | Steven Shapiro | Fraud and Abuse | Litigation | Pharmaceuticals
On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as …
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Walgreens Pays $269.2 Million to Settle Fraud Allegations
January 24, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
Walgreens Boots Alliance, Inc., the operator of the Walgreens pharmacy chain, has agreed to pay $269.2 million in two settlements with the U.S. Department of Justice to resolve fraud allegations. The two cases arose from lawsuits filed by whistleblowers under the False Claims Act and were prosecuted federally by the U.S. Attorney’s Office for the Southern …
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The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud
January 7, 2019 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
Evan Krinick authored an article, “The False Claims Act: A Powerful Tool Against Federal Health Care Program Fraud,” that was published in the New York Law Journal.  The article discusses recent actions taken by U.S. Attorneys in New York against health care providers under the FCA. …
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Midterm Election Results: 6 Ways Healthcare Could Change in 2019
December 27, 2018 | Rivkin Rounds Staff | Affordable Care Act | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
A December 6 article in Managed Healthcare Executive, “Midterm Election Results: 6 Ways Healthcare Could Change in 2019,” discussed how Congress may attempt to address various healthcare issues next year. Rivkin Radler’s Eric Fader was quoted in the article. Eric pointed out that the recently enacted Know the Lowest Price Act and Patient Right to Know Drug Prices Act will …
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Diabetes Pill Marketers Settle FTC Complaint
December 14, 2018 | Steven Shapiro | Fraud and Abuse | Litigation | Pharmaceuticals
On December 4, the Federal Trade Commission (FTC) announced the settlement of a complaint against Nobetes Corporation, which marketed and sold a pill that supposedly treats diabetes. The FTC complaint had alleged that the company made false or unsubstantiated health claims, engaged in illegal billing practices, and used deceptive endorsements in the marketing and sale …
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DOJ Files Amicus Brief Declaring Intention to Dismiss FCA Case
December 12, 2018 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Pharmaceuticals
On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former …
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FDA Reviews Clinical Research Approval Process
November 28, 2018 | Cassandra Rivais | Legislation and Public Policy | Pharmaceuticals
The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year. In order for a new drug to …
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340B Program Changes Finally on the Fast Track
November 6, 2018 | Ada Kozicz | Legislation and Public Policy | Pharmaceuticals
The U.S. Department of Health and Human Services (HHS) has issued a proposed rule that would speed up implementation of its previously issued 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Final Rule”). The proposed rule would move up the effective date of the Final Rule by six months, from …
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Kaiser to Present on PLI Panel on Enforcement Trends
November 5, 2018 | Eric D. Fader | False Claims Act | Fraud and Abuse | Medical Devices and Wearables | Pharmaceuticals
On November 16, 2018, Geoffrey R. Kaiser will join the faculty of the Practising Law Institute’s Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries. Jeff will participate on a panel entitled, “Enforcement Trends Impacting the Drug and Device Industries.” Topics covered will include the False Claims Act, the Anti-Kickback Statute, off-label …
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