Pharmaceuticals


New Rule Requires Drug Price Disclosure in TV Ads
May 15, 2019 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
On May 8, the U.S. Department of Health and Human Services announced a final rule from the Centers for Medicare & Medicaid Services requiring pharmaceutical companies to disclose the list prices of prescription drugs in television advertisements. The rule will apply to all drugs covered by Medicare or Medicaid that cost at least $35 per …
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New Plan Designs for Medicare Parts C and D are Coming
April 9, 2019 | Christopher J. Kutner | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On April 5, the Centers for Medicare & Medicaid Services (CMS) issued a final rule (CMS-4185-F) that updates the Medicare Advantage (MA or Part C) and Medicare Prescription Drug Benefit (Part D) programs by promoting innovative plan designs, improved quality, and choices for patients. The final rule will increase MA plan choices for the 2019 …
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Rivkin Attorneys to Speak on CBD
April 8, 2019 | Marc S. Ullman | Steven Shapiro | FDA | Legislation and Public Policy | Pharmaceuticals
Rivkin Radler’s Marc Ullman and Steven Shapiro will be addressing the question “What Is the Regulatory Current State of Play With CBD?” on Wednesday, April 10, at the SupplySide East trade show in Secaucus, NJ.  Marc’s article “Regulations Remain Hazy Around CBD Use in Supplements” was recently published in the Spring/Summer 2019 issue of USLAW …
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FDA and FTC Warn CBD Marketers
April 8, 2019 | Marc S. Ullman | FDA | Legislation and Public Policy | Pharmaceuticals
On March 28, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent joint Warning Letters to three marketers of products represented as cannabidiol (popularly known as CBD) dietary supplements. According to the letters, the products are being marketed with questionable claims indicating that they can be used to treat a variety …
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New Medicare App to Explain Coverage
February 6, 2019 | Cassandra Rivais DiNova | 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 | FDA | 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 | FDA | 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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