Christopher H. Schott

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.