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

Last week, the 11th Circuit Court of Appeals handed down its long-awaited decision in United States v. AseraCare, Inc. The case, brought under the False Claims Act (FCA) and argued way back in March 2017, alleged that AseraCare, a for-profit multi-state hospice chain, had submitted false claims to the Medicare program for patients who were

The U.S. Department of Health and Human Services (HHS) announced on September 9 that Bayfront Health St. Petersburg (Bayfront), a 480-bed Florida hospital, has paid HHS’s Office for Civil Rights (OCR) $85,000 to settle a potential violation of HIPAA’s right of access provisions. Bayfront’s Resolution Agreement with HHS also provided for the company to enter into a one-year

The Manhattan U.S. Attorney’s Office recently announced that the U.S. Department of Justice has intervened in a whistleblower suit against Life Spine Inc., an Illinois-based manufacturer of spinal implants, devices and equipment. The lawsuit, which seeks damages and civil penalties under the False Claims Act (FCA), claims that Life Spine paid millions of dollars in

As parents and healthcare providers prepare for the start of the new school year, there are now more than 26,000 students who will need to get vaccinated as New York has eliminated exemptions from vaccinations due to religious beliefs. New York Public Health Law §§ 2164 and 2165 require students to be immunized against diphtheria,

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

A physician who operated weight-loss clinics in Georgia is facing 33 months in prison after pleading guilty to Conspiracy to Unlawfully Dispense Controlled Substances (Oxycodone), according to a June 13 press release issued by the U.S. Department of Justice. Dr. Johnny Di Blasi was arrested at Miami International Airport as he was attempting to flee

The U.S. Department of Justice announced on June 5 that Arizona-based opioid manufacturer Insys Therapeutics agreed to pay $225 million to settle civil and criminal kickback charges. Last month, Insys’s founder and former CEO John Kapoor was found guilty on federal racketeering charges arising out of a bribery scheme that rewarded the company’s sales managers

In a 7-1 decision, the U.S. Supreme Court ruled on June 3 that the Department of Health and Human Services (HHS) may not adjust the rates it pays hospitals for serving low-income patients without first giving them an opportunity to comment on the changes. The Medicare Act requires public notice and a 60-day comment period

The U.S. Department of Health and Human Services (HHS) announced on May 23 that Medical Informatics Engineering, Incorporated (MIE), an Indiana-based online electronic health records company, had agreed to pay HHS’s Office for Civil Rights (OCR) $100,000 to settle HIPAA violations. MIE’s April 23 Resolution Agreement with HHS also provided for the company to enter