On August 25, 2023, the FDA issued a Guidance providing for a one-year enforcement discretion period for the Drug Supply Chain Security Act (DSCSA) requirement of electronic interoperability for tracking transactions. The delay was actively sought... Read More
Home infusion pharmacies face a unique set of challenges and requirements in providing care to patients in the comfort of their homes. This is equally true when it comes to the Medicare Part D benefit, which provides coverage for prescription... Read More
On June 27, 2023, the FDA issued its long-awaited draft guidance on activities it considers wholesaling and those that it does not in the context of Section 503B’s prohibition on wholesaling of products compounded by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
Pharmacies face serious PBM risks when issues that arise in audits are not properly addressed from recoupments and network terminations, to governmental investigations. Preparation and preventative measures are key to ensuring a positive audit... Read More
In an ongoing trend, pharmacy benefit managers ("PBMs") have reinforced their terms and conditions on network pharmacies’ involvement on the prior authorization process. As we discussed last year (read here), health plans utilize the prior... Read More
Frier Levitt Partner Jesse C. Dresser was quoted in a Managed Healthcare Executive article, “States, Not Federal Government, Are Moving to Tighten Regulation of PBMs" by Denise Myshko. While legislation to regulate abusive PBM practices has been... Read More
IV hydration services are becoming increasingly popular across the country as they offer a convenient way for individuals to receive intravenous vitamins, nutrients, or hydration on demand. In addition to traditional brick-and-mortar locations, in... Read More
In an effort to gain market access for new drugs and to shift the conversation from one of “volume” to one of “value,” pharmaceutical manufacturers are increasingly offering and agreeing to alternative payment models that set the price of a... 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
There have been numerous legal and regulatory developments over the past year that pertain to 503A pharmacy compounding. In Part 1 of this two-part series, we discussed revisions to the United States Pharmacopeia’s (“USP”) guidelines for... Read More
