On June 27, 2022, FDA issued a Proposed Rule which would facilitate Rx to OTC switches. While OTC products are typically for acute self-limiting conditions, OTC use of certain prescription medications for chronic diseases or conditions would be... Read More
The Federal Trade Commission recently announced that it will intensify scrutiny of pharmacy benefit managers (“PBMs”) business practices. The agency intends to issue compulsory orders to the six largest PBMs in the U.S. for information about... Read More
Frier Levitt was recently successful in having a Board of Pharmacy case against a pharmacist and retail pharmacy dismissed. Underlying the Board of Pharmacy action was a PBM audit that alleged unprofessional conduct against the pharmacy and its... Read More
In a recent trend, compounding pharmacies have been receiving notices of audit from the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”). In the notice, OIG requests that the pharmacies submit... Read More
Earlier this week, the U.S. Supreme Court ruled that to secure convictions under the federal Controlled Substances Act (“CSA”) for excessive prescribing of controlled substances, including opioids, prosecutors must prove beyond a reasonable... Read More
In part one of this article series, Frier Levitt dissected the May 9, 2022, Centers for Medicare and Medicaid Services (CMS) Final Rule (Final Rule) entitled, “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare... Read More
Frier Levitt recently received an impressive $3.6 million arbitration award against Caremark and SilverScript on behalf of a specialty pharmacy client, Mission Wellness, arising from improper DIR Fees. Despite repressive "gag clauses" imposed by... Read More
The Department of Justice (“DOJ”) recently established the Elder Justice Initiative (“EJI”), which directs Government efforts to combat elder abuse, neglect, and financial fraud. The EJI seeks to address several schemes affecting older... Read More
Two practices in Connecticut recently settled large six-figure lawsuits with federal and state agencies resolving allegations of improperly employing an individual who was excluded from all federal healthcare programs. In both instances, the... Read More
Cerebral, Inc., a telehealth startup offering virtual treatment for multiple mental health conditions including anxiety, depression, insomnia, and attention-deficit/hyperactivity disorder (“ADHD”), is currently facing several legal proceedings... Read More
