Christopher Schott primarily advises on price reporting and other compliance obligations related to the Medicaid, Medicare, and 340B drug pricing programs. 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 Mr. Schott’s advice when evaluating potential opportunities and strategies.
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 Mr. Schott 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 Mr. Schott bases his counsel on a full consideration of the client’s product portfolio, distribution model, and strategic goals.
The drug pricing policy landscape is ever evolving, and Mr. Schott assists clients through policy advocacy, such as by evaluating legislative and policy proposals, drafting white papers, and meeting with stakeholders. Mr. Schott 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.
Mr. Schott 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 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.
Mr. Schott routinely counsels clients on a wide variety of matters where price reporting obligations are relevant, including, among others:
- Food and Drug Administration (FDA) considerations — Seeking approval under a new application or via a supplement, as well as the assignment of National Drug Codes, can have significant price reporting (and down-stream) impacts, which is why Mr. Schott works closely with Latham’s Healthcare & Life Sciences regulatory team to advise clients during the early stages of product development.
- Drug launch planning — Mr. Schott supports manufacturers during all stages of launch planning, such as by assessing pricing and discounting strategies in light of price reporting obligations, or when evaluating whether to participate in the federal programs in the first instance.
- Commercialization and contracting strategies — Commercial distribution agreements, such as wholesaler contracts, group purchasing organization (GPO) agreements, and managed care proposals, as well as innovative contracting strategies like value-based or outcomes-based pricing, can be relevant for the price reporting metrics. Mr. Schott helps clients evaluate and structure these arrangements in light of price reporting considerations. He also counsels clients on the relevance of the bundled sale definition and bona fide service fee determinations.
- Compliance training — Mr. Schott provides background regarding the federal programs and price reporting obligations to the certifiers (often C-suite executives). He also works directly with business, contracting, and finance personnel to provide compliance training (including as part of satisfying corporate integrity agreement obligations) and periodic updates on legal and other program developments.
- Patient benefit programs — The treatment of manufacturer-sponsored patient benefit programs in the price reporting metrics has become a focus of regulators and policymakers, and Mr. Schott helps clients evaluate their programs in light of these requirements.
- Focus on evolving policies and legal standards — Policies and legal standards related to drug pricing are changing at an accelerating pace, and Mr. Schott helps clients stay abreast of these developments. For example, the Centers for Medicare and Medicaid Services (CMS) recently issued a new regulation addressing line extensions and new formulations, and Mr. Schott is assisting clients with planning for the implementation of the regulation in advance of its January 1, 2022 effective date.
- Government inquiries and enforcement — Mr. Schott frequently helps clients respond to inquiries from CMS and other regulators, and he works closely with Latham’s White Collar Defense & Investigations Practice to support clients facing government investigations.