Santa Cruz, California, United States
Seasoned in-house healthcare attorney specializing in commercial and regulatory matters related to all aspects of the pharmaceutical business, including drug sale and distribution, regulatory matters, drug pricing, pharmacy benefit management and third-party payor practices, private and government reimbursement methodologies, the 340B program, and state and federal pharmaceutical legislative initiatives. Uniquely experienced in the healthcare field as a result of 20 years as in-house counsel for a diverse spectrum of dynamic industry leaders, including Kaiser Permanente, McKesson, and Gilead Sciences. Highly respected by peers and clients for business expertise and communication style and skills. Berkeley Law grad (1998) and US Peace Corps Volunteer, Czechoslovakia (1991 – 1994).
Provide legal guidance and support to senior leadership and commercial teams to develop and execute pricing, rebate and discounting contracting strategies in various payer and provider channels. Work closely with commercial, finance, operations, and brand teams to assess, develop and execute payer, provider and GPO contracting strategies for product portfolio. Negotiate and draft pricing, rebate and discount agreements in payer and provider channel segments including specialty distributors, wholesalers, GPOs, specialty pharmacy, retail pharmacy, community clinics, 340B and non-340B hospital segments. Provide advice to senior leadership team with respect to the effect of various discounts and rebates on the company’s government pricing and reimbursement reporting obligations related to ASP, Best Price, WAC, AMP, and AWP. Advise company leadership on Inflation Reduction Act.
Responsible for commercial and regulatory support to Kaiser's national pharmaceutical sourcing, contracting, and pharmacy benefits teams. Advised internal clients on legal and regulatory matters related to drug access, distribution, pricing, and reimbursement through private and government payors. Negotiated and drafted a wide range of pharmaceutical-related agreements, including purchase, rebate, PBM, payor, service fee, and other agreements. Counseled organization on 340B regulatory and pricing matters. Collaborated with organization's government relations team on a variety of state and federal legislative initiatives involving pharmaceutical matters.
Negotiated and drafted pharmaceutical supply agreements with retail pharmacies, GPOs, hospitals, and health systems. Oversaw a team of attorneys responsible for pharmaceutical supply agreements, and trained and educated the team on the path and pricing a drug experiences from the manufacturer to the patient. Redesigned template distribution agreement for the supply of pharmaceuticals and led all distribution agreement stakeholder groups in implementing same. Advised internal teams and stakeholders on structuring pharmaceutical transactions to ensure compliance with healthcare laws. Provided counsel to compliance and internal audit teams and collaborated with same. Tracked payor efforts to establish “average acquisition cost” as a reimbursement metric for retail pharmacies. Provided regulatory guidance to company’s business unit responsible for helping independent pharmacies interested in buying or selling retail pharmacy locations. Advised company’s managed care business unit on legal and contract matters when transacting with PBMs. Advised business clients on 340B drug discount program rules and regulations.
Advised company’s commercial organization on healthcare fraud and abuse risks when interacting and/or contracting with pharmacies, healthcare professionals, commercial, state and federal payers, managed care organizations (including PBMs). Counseled company on statutory and regulatory drug price reporting obligations under Medicaid, Medicare and the 340B program, as well as pricing restrictions and contracting requirements under the Veterans Health Care Act and company’s Federal Supply Schedule contract. Led business stakeholders through fair market value and bona fide service fee assessments. Managed, negotiated and closed various commercial transactions, including inventory management agreements with wholesalers and drug distribution and other arrangements with pharmacies. Negotiated and drafted formulary and access rebate agreements with managed care organizations and PBMs, including rebate agreements with Medicare Part D plan sponsors. Led effort seeking coding, coverage and reimbursement of a nebulizer device used to inhale company’s cystic fibrosis drug. Counseled company regarding Risk Evaluation and Mitigation Strategy (REMS) obligations for company’s pulmonary arterial hypertension product. Tracked Affordable Care Act and counseled company regarding implementation of mandated changes. Provided guidance to company regarding federal and state privacy laws.
Negotiated and drafted wholesale distribution, managed care rebate, Medicaid rebate, confidentiality, consulting, licensing, material transfer, manufacturing and quality agreements. Member of promotional review committee; reviewed promotional materials for fair balance and false claims, including misbranding and off label claims. Advised company regarding development and implementation of government drug price reporting policies, calculations, systems and methodologies. Counseled company regarding sales and pricing strategies for existing and new drug products. Counseled company regarding obligations under the Medicare Modernization Act, the Deficit Reduction Act, and proposed federal and state legislation regarding the disclosure of manufacturer payments to healthcare providers.