Chris Schott primarily advises on price reporting and other compliance obligations related to the Medicaid, Medicare, and 340B drug pricing programs, with a focus on market access. He combines extensive regulatory insight with deep industry knowledge to support pharmaceutical clients at all stages of the product life cycle. Market entrants and investors also seek Chris’s advice when evaluating potential opportunities and strategies.
The drug pricing policy landscape is ever evolving. For example, the Inflation Reduction Act is significantly impacting the pharmaceutical industry, and clients turn to Chris to put these developments into perspective and provide strategic advice. This includes assisting with compliance efforts, but also with challenges to government overreach, whether in court or through other avenues.
Chris assists clients through policy advocacy, such as by evaluating legislative and policy proposals, drafting white papers, and meeting with stakeholders. Chris also helps pharmaceutical manufacturers proactively engage with federal regulators through in-person advocacy and comment drafting. Additionally, he frequently advises drug manufacturers seeking guidance from regulators regarding specific issues or commercial proposals.
Methodologies and reasonable assumptions that support the periodic certification and submission of price reporting metrics are at the heart of compliance with the federal programs, and Chris frequently advises clients in connection with reporting Average Manufacturer Price and Best Price under the Medicaid Drug Rebate Program, Average Sales Price under Medicare Part B, and the 340B ceiling price. The definitions of the price types and how the federal programs use the data are relevant to many different facets of the pharmaceutical business, which is why Chris bases his counsel on a full consideration of each client’s product portfolio, distribution model, and strategic goals.
Chris draws on his regulatory knowledge and understanding of the pharmaceutical industry to support a range of corporate transactions, including acquisitions and divestitures, as well as licensing and co-promotion arrangements. He regularly helps clients to evaluate the impact of price reporting requirements on proposed mergers and acquisitions, as well as to navigate due diligence matters and the post-closing transition of regulatory responsibilities.
Chris routinely counsels clients on a wide variety of matters where price reporting obligations and market access considerations are relevant, including, among others:
Latham lawyers honored for securing the dismissal of a securities fraud complaint brought against Funko and its former CEO and CFO, and for a win at the D.C. Circuit for United Therapeutics.
Latham recognized for wins for Ferrellgas and United Therapeutics.