Pharmaceuticals


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 | 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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Class Action Claims Reinstated on “Adulterated” Dietary Supplements
November 25, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Litigation | Pharmaceuticals
The 11th Circuit Court of Appeals recently reversed a Florida lower court decision that dismissed class action claims under the Florida Deceptive and Unfair Trade Practices Act, the Illinois Consumer Fraud and Deceptive Business Practices Act, and the New York General Business Law alleging that the defendants defrauded the putative class by selling adulterated dietary …
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Wave of DOJ Actions Targets Healthcare Fraudsters
October 3, 2019 | Eric D. Fader | False Claims Act | Fraud and Abuse | Home Health | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Telehealth
The U.S. Department of Justice (DOJ) kicked its healthcare fraud enforcement activities into high gear last week, unveiling charges against hundreds of individuals and companies for paying kickbacks and billing for unnecessary drugs, supplies and tests. The cases, which alleged nearly $1.5 billion in fraudulent claims to Medicare, Medicaid and private insurers, targeted specialty pharmacies, …
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Kaiser to Present at PLI Life Sciences Program
September 17, 2019 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and …
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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes. The HemoCare device was designed by …
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FDA Warns on CBD Dietary Supplements
July 17, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce …
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