John Gould's practice spans a broad range of healthcare compliance counseling, transactional, and public policy matters for pharmaceutical, biological, and medical device manufacturers, and focuses on drug price reporting, the federal anti-kickback statute, and market access issues. In the drug pricing area, Mr. Gould advises on Medicaid, Medicare, Department of Veterans Affairs, and 340B Program requirements, as well as state drug pricing laws. Mr. Gould assists clients with price reporting restatements, investigations, litigation, and public comments on proposed rules. Mr. Gould leads interdisciplinary teams to assist clients with managed markets issues, including customer contracts, limited distribution networks, and patient support programs.
Experience
- Provide day-to-day counsel to major drug manufacturers on drug price reporting compliance issues.
- Develop price reporting compliance policies and reasonable assumptions documents for major drug manufacturers.
- Advised major drug manufacturer on response to HHS Office of Inspector General average manufacturer price (AMP) survey.
- Drafted comments on Centers for Medicare and Medicaid Services proposed rules and guidance regarding drug reimbursement and price reporting issues.
- Counseling regarding restatements of drug pricing metrics to the government, and disputes with states regarding Medicaid rebates.
- Perform internal audits of price reporting practices and documentation.
- Oversee and advise on the documentation of "fair market value" of service fee arrangements.
- Counsel litigation team on price reporting obligations as they relate to a False Claims Act enforcement action.
- Counsel transactional teams on drug price reporting rules related to authorized generics transactions.
- Meet with the Centers for Medicare and Medicaid services on pricing and reimbursement matters.
Perspectives
Recognition
Credentials
Education
- J.D., University of Pennsylvania Carey Law School, 2003, magna cum laude, Order of the Coif
- Master of Bioethics, University of Pennsylvania, 2003
- B.S., Molecular Biophysics and Biochemistry, Yale University, 1999, magna cum laude
Admissions
- District of Columbia