John Gould's practice spans a broad range of compliance counseling, transactional, and public policy matters, and focuses on drug price reporting obligations, the federal anti-kickback statute, and managed markets contracting. In the pricing area, Mr. Gould advises on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting laws. Mr. Gould assists clients with restatements, investigations, and litigation related to drug price reporting, and drafts public comments on proposed rules and guidance. Mr. Gould assists clients with managed markets issues, including drafting template customer discount and service fee arrangements, advising on related price reporting, compliance, and commercial legal issues, and auditing client compliance with best practices in these areas. Mr. Gould also provides regulatory review for due diligence matters in these same subject matter areas.

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

Questions & Answers Guide to FDA’s Prescription Drug Importation Proposals
Advisory
Medicaid Calculation Challenges: Delving Deeper into the Tougher Issues
Rx Drug Pricing Boot Camp, Philadelphia, PA
HHS Proposes New Protections for Value-Based Arrangements and Other Revisions to AKS Safe Harbors, CMP Exceptions and Stark Exceptions
Advisory
HHS OIG's Proposed Rule Revising the AKS Safe Harbors and Beneficiary Inducement CMP Rules: Information for Drug and Device Manufacturers
Advisory
Innovative Pricing and Contracting Processes
Medicaid Drug Rebate Program Summit 2019, Chicago, IL
More

Credentials

Education
  • JD, University of Pennsylvania Law School, 2003, magna cum laude, Order of the Coif
  • Master of Bioethics, University of Pennsylvania, 2003
  • BS, Molecular Biophysics and Biochemistry, Yale University, 1999, magna cum laude
Admissions
  • District of Columbia
Overview

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