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

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

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.

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

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

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,

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

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

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

A New York anesthesiologist was indicted on July 9 for conspiring with pharmacies and medical equipment suppliers to defraud the Medicare program and other insurers. Anna Steiner, also known as Hanna Wasielewska, allegedly wrote prescriptions for drugs and durable medical equipment for patients supposedly seen via telemedicine without ever having actually examined or evaluated the