Practice Focus

John Gould's practice spans many healthcare and FDA compliance and public policy matters, and focuses on pharmaceutical pricing, the federal anti-kickback statute, and state law compliance. In the pricing area, Mr. Gould advises pharmaceutical and biotechnology companies on federal Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state price reporting laws. Mr. Gould has counseled clients on compliance with state limitations on gifts to providers and marketing reporting requirements, and on compliance with FDA drug promotion laws.  Mr. Gould has represented clients in investigations and litigation related to drug pricing, promotion, and manufacturing, and has sought improved Medicare reimbursement for drugs and medical devices.  Mr. Gould has also advised clients on issues related to the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, the comprehensive healthcare reforms enacted in March 2010.

While attending the University of Pennsylvania Law School, Mr. Gould earned both a masters degree in Bioethics and a JD. Before law school, Mr. Gould developed pharmaceutical company sales and marketing strategies at the consulting firm ZS Associates, and performed scientific research in pharmaceutical manufacturer and academic laboratories.

Representative Matters

• Counseling major pharmaceutical and medical device manufacturers on various sales, marketing, and other corporate programs, e.g., bundled sales, samples, patient assistance, product support services, product replacement, coupons, vouchers, and grants.
• Preparing price reporting policies and Medicaid rebate and Average Sales Price reasonable assumptions for major pharmaceutical companies.
• Developing PBM, managed care, and Medicare Part D agreements for major pharmaceutical companies.
• Drafting submissions to the HHS Office of Inspector General, including advisory opinion requests.
• Preparing comments for pharmaceutical clients on Medicare proposed rules.
• Analyzing the Medicare reimbursement landscape for new products.
• Obtaining HCPCS codes for a new medical device.
• Analyzing FDA, anti-kickback statute, and Medicare billing compliance for due diligence projects.
• Counseling a medical device manufacturer and supplier on Medicare billing rules.
• Seconded to major biotechnology and pharmaceutical companies to provide FDA promotion and drug pricing counseling.