Wendy C. Goldstein leads the firm’s Health Care & Life Sciences Regulatory practice.
Ms. Goldstein concentrates in healthcare fraud and abuse and government health care program matters relevant to manufacturers, payors and other ancillary providers in the health care life sciences space. She also represents those entities that invest in such concerns. Specifically, she is involved with:
- Counseling clients regarding the research, manufacture, sale, promotion, distribution, pricing and import/export of pharmaceuticals, biologics and medical devices. Such counsel includes topics relating to fraud and abuse, the Food, Drug and Cosmetic Act (FDCA), the Prescription Drug Marketing Act (PDMA), third party coverage and reimbursement (government and commercial), Medicaid Drug Rebate and other government pricing programs, corporate compliance, health privacy and security (including HIPAA and state laws), antitrust, Medicare Part D program, transparency laws and other state law issues;
- Counseling regarding government health care program compliance risks, including designing, implementing and assessing the effectiveness of corporate compliance programs; conducting board of directors training; conducting internal investigations relating to compliance matters; providing self-disclosure counsel; and preparing Office of the Inspector General of Department of Health & Human Services (OIG) advisory opinion requests;
- Drafting and negotiating co-promote agreements, drug rebate agreements, supply chain arrangements, fee-for-service agreements and third-party vendor arrangements;
- Conducting health regulatory due diligences;
- Defending pharmaceutical manufacturers in all phases of government investigations and inquiries, and negotiating settlement agreements and OIG corporate integrity agreements on behalf of manufacturers in connection with the resolution of qui tam and other government actions, defending companies in data breaches;
- Counseling third-party payors in connection with the delivery of outpatient prescription drug benefit and specialty drug benefit programs offered under insured (commercial and government) and self-insured products. Such counsel includes topics relating to fraud and abuse, reimbursement, coverage, relationships with vendors such as pharmacy benefit managers, wholesalers and dispensers, Medicare Part D, ERISA, corporate compliance, privacy, antitrust and state law issues.
Prior to joining Cooley, Ms. Goldstein served as a partner in the New York office of a leading law firm specializing in, among other practices, health care and life sciences where she was the chair of the firm’s Health Care and Life Sciences Practice Steering Committee and the Pharmaceutical Industry Health Regulatory Practice Group.