Mountain Lakes, New Jersey, United States
Accomplished health care attorney with extensive experience advising clients on contracting, regulatory compliance, reimbursement policy, and business strategy development. In depth knowledge of pharmaceutical, healthcare insurance, and government policy issues. Recognized as a clear and concise writer with polished presentation skills. Impeccable ethics and integrity.
Led team of attorneys providing strategic and tactical guidance on market access contracting (commercial and Medicare Part D); government pricing and reporting issues, including federal contracting requirements; and reimbursement issues. Oversaw development of CAR T commercialization contract templates and coordinated with cross-functional teams on development of commercialization strategy. Reviewed and advised senior leadership and corporate pricing committee on strategic pricing decisions as to legal, business, and reputational considerations. Ensured U.S. Market Access compliance with applicable laws, including the Anti-Kickback Statute and other U.S. healthcare compliance laws and regulations. Internal lead for cross-functional team charged with Crisis Management planning, including preparation of senior leaders and implementation of response plans for political and other inquiries.
Guided and supported team members in seeking intra-company cross-enterprise collaborations to improve health outcomes..
Built and led new internal assurance review and governance team designed to provide compliance guidance in identification and development of strategic collaborations with managed markets customers. Received “green” finding from internal audit after first year of new function.
Provided general legal and compliance guidance to commercial and market access business partners regarding: pharmaceutical regulations, including the Anti-Kickback Statute and other Fraud & Abuse laws; contracting with distributors, insurers, pharmacy benefit managers, group purchasing organizations and integrated health systems; government health care program price reporting; and Medicare Parts B and D coverage and reimbursement.
Analyzed, advised on, and resolved a wide variety of complex health care-related issues including privacy/HIPAA, Medicare reimbursement policy, and provider appeals.