Area of focus

Health Legislation and Policy

The process by which U.S. federal legislation affecting the health industries is enacted is complex and often counterintuitive. That is why effective participation in the legislative process often requires hands-on experience on Capitol Hill and in the administrative agencies, in addition to in-depth knowledge of health...

Representative experience

Secured US$10m in Title VII funding for pediatric dentistry residency and loan repayment programs on behalf of the American Academy of Pediatric Dentistry.

Assist a client in obtaining funding for eye and vision research in the defense appropriations bill resulting in over US$20m in the last six fiscal years.

Worked with leading research institutions, major industry associations, key House and Senate leaders, and the administration to secure a positive CMS coverage determination for bone-anchored hearing devices.

Represented pharmaceutical and biologics companies in connection with numerous federal and state investigations of sales and marketing, pricing, Medicaid rebate, FDCA promotional issues, and cGMP compliance.

Advised a drug company on strategies for obtaining orphan drug approval and worked with scientific and regulatory groups to draft and submit designation request.

Lobbied Congress on behalf of Insulet to get CMS approval for an insulin delivery product.

Succeeded in working with a national health professional organization to secure over US$10m in direct funding for specific health professional training and loan guarantees.

Worked with several corporations and industry associations to secure critical appropriations report language supporting access and reimbursement for specific medical technologies.

Advised a U.S. medical device company on regulatory and commercial issues regarding the market launch of a gene test in 24 European countries.

Instrumental in persuading the FDA to change longstanding regulatory position on awarding exclusivity to fixed-dose combination products, benefitting Gilead's products in the HIV and Hepatitis C fields.

Lead agency counsel for implementation of Affordable Care Act, including provisions governing health insurance coverage and Medicare Advantage plans.

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