On June 27, 2023, the FDA issued its long-awaited draft guidance on activities it considers wholesaling and those that it does not in the context of Section 503B’s prohibition on wholesaling of products compounded by outsourcing facilities. Once... Read More
Continuing its aggressive efforts to combat fraud, waste and abuse in the health care system, the Federal government has focused on providers’ practices related to the disposing of and billing for single-use drugs and biological waste. Frier... Read More
PRESS RELEASE – New Jersey/New York, March 28, 2023 – Jonathan Levitt, a renowned trial attorney in the healthcare and life sciences industries and the co-founding partner of Frier Levitt, has been invited to testify before the U.S. Senate... Read More
Frier Levitt helped a New York pharmacy successfully appeal initial audit results in their entirety that were issued by a large PBM. Despite the pharmacy’s submission of purchase information directly from its wholesalers, the PBM alleged... Read More
Pharmacies and pharmacists (“licensees”) throughout the country are often anxious after learning that a State Board of Pharmacy (“BOP”) is seeking disciplinary action against them. The fear of challenging a BOP’s allegations, the same... Read More
On January 15, 2023, the Vermont Department of Financial Regulation (the “Department”) issued a report titled “Act No. 131 (2022) Report: Pharmacy Benefit Management” (the “Report”). As the title suggests, the Department was required... Read More
Since New York’s Pharmacy Benefits Bureau (“Bureau”) was first established in May 2022, Frier Levitt has been monitoring all developments related to the Bureau including its subsequent regulation of Pharmacy Benefit Managers (“PBM”). As... Read More
Since being established in May 2022, New York’s Pharmacy Benefits Bureau (“Bureau”) has requested input from the public on six separate occasions regarding New York’s laws governing Pharmacy Benefit Managers (“PBMs”). The Bureau’s... Read More
Frier Levitt successfully helped a Louisiana-based pharmacy resolve a finding for overpayment from a large insurance plan, who demanded a significant sum of money be returned to the plan on the basis that prior authorizations obtained by the... Read More
In today’s ever-changing digital age, more and more human processes are being replaced by computers, with pre-coded algorithms, and now, through artificial intelligence. These same advancements that have created tools across multiple industries... Read More