Pharmaceuticals


Teva under Fire from DOJ
August 27, 2020 | Eric D. Fader | Antitrust | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid | Pharmaceuticals
Teva Pharmaceuticals USA Inc. is in the crosshairs of the U.S. Department of Justice (DOJ) on two separate matters. On August 18, the DOJ announced that it filed a lawsuit against Teva and an affiliate, Teva Neuroscience Inc., under the False Claims Act for violations of the federal Anti-Kickback Statute. The suit alleges that the …
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HHS, DOJ Release Fraud and Abuse Report
July 23, 2020 | Eric D. Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Home Health | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion, of which about $2.5 billion was returned to the Medicare trust fund. The recoveries included judgments and settlements from fraud …
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Rivkin Health Attorneys Write the Book on Federal AKS and Safe Harbors
July 10, 2020 | Rivkin Rounds Staff | Electronic Health Records | Employer/Employee | False Claims Act | Fraud and Abuse | Hospitals | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
Eric Fader, Jeff Kaiser, Chris Kutner, Ada Kozicz and Ben Malerba are authors of the newly released book, “The Federal Anti-Kickback Statute and Safe Harbors: A Practical Guide.” Published by the American Bar Association, the book covers all safe harbors currently in place, as well as the interplay between the Anti-Kickback Statute (AKS) and other …
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Drug Price Disclosure Rule Rejected Again
June 17, 2020 | Eric D. Fader | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals
On June 16, the U.S. Court of Appeals for the District of Columbia Circuit upheld a ruling from a year ago that struck down a federal regulation requiring pharmaceutical companies to disclose wholesale prices of prescription drugs in television advertisements. The appeals court agreed with the lower court’s opinion that the rule exceeded the legal …
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DOJ Charges California Physician with COVID-19 Fraud
April 21, 2020 | Marc S. Ullman | FDA | Fraud and Abuse | Litigation | Pharmaceuticals
On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by Dr. Staley …
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CISA Guidance Clarifies “Essential Industry” for Healthcare
March 31, 2020 | Marc S. Ullman | Behavioral Health | Home Health | Hospitals | Legislation and Public Policy | Medical Devices and Wearables | Nursing Homes | Pharmaceuticals
On March 28, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response. This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA agency …
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No Cost-Sharing for Coronavirus Testing in NY
March 5, 2020 | Eric D. Fader | Hospitals | Legislation and Public Policy | Medicare and Medicaid | Pharmaceuticals | Private Insurers | Telehealth
On March 2, New York Gov. Andrew Cuomo announced new regulations on New York health insurers regarding coverage for coronavirus testing and related matters. The State Department of Financial Services (DFS) directive requires insurers to waive cost sharing for COVID-19 testing at emergency room, urgent care and office visits. In addition, Medicaid patients will not …
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DOJ Reports $3 Billion in 2019 False Claims Act Recoveries
January 14, 2020 | Eric D. Fader | False Claims Act | Fraud and Abuse | Hospitals | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals
The U.S. Department of Justice (DOJ) announced last week that in the fiscal year ended September 30, 2019, it obtained more than $3 billion in total recoveries from civil cases brought under the False Claims Act (FCA). The total, a slight increase from the $2.9 billion recovered in the prior fiscal year, included both settlements …
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The Broad Reach of the Medicare Fraud Strike Forces
January 3, 2020 | Rivkin Rounds Staff | False Claims Act | Fraud and Abuse | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
Rivkin Radler’s Evan Krinick authored an article for the New York Law Journal, “The Broad Reach of the Medicare Fraud Strike Forces.” The article discusses recent strike force actions in New York and New Jersey that targeted a variety of healthcare fraud schemes.   …
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FDA Warns 15 More Companies on CBD
November 26, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
On November 25, the U.S. Food and Drug Administration announced the issuance of warning letters to 15 companies that it says are violating the Federal Food, Drug, and Cosmetic Act by selling cannabidiol (CBD) products. The FDA’s views on the recent CBD marketing frenzy have been no secret, as previously discussed here. The FDA also …
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