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Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

“I offer health systems and other providers important insight into the regulatory process, helping them to understand complex rule-making, how to impact agency guidance, and ways to advocate before agency officials.”

Kristen O'Brien

Principal

Kristen is principally responsible for the health policy group’s work with delivery system clients, including large physician groups, integrated health systems and other provider organizations. Her focus includes both substantive legal and regulatory advice, in addition to direct advocacy before government decision-makers.

Kristen is especially active in providing legal analysis and counsel related to government health payment programs under Medicare and Medicaid. Her areas of substantive focus include:

In particular, she has advised clients on aligning reporting requirements, improving quality and reducing costs.

Kristen also has substantial experience working to implement new laws through the rule-making process, as well as working with relevant agency officials to develop regulations and other agency guidance. In particular, she has considerable experience working with the Centers for Medicare & Medicaid Services (CMS), the Office of Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC) and the Center for Program Integrity (CPI).

Prior to her work at OFW Law, Kristen was a senior legislative counsel with the American Medical Association, where she provided legislative and regulatory analysis on an array of issues impacting physicians. This work included the legal review of Medicare and Medicaid requirements, data transparency, and health information technology, as well as coordinating and aligning advocacy initiatives with state and specialty medical societies.

Before working at the AMA, Kristen worked in private practice at a national law firm where she provided counsel to health care industry clients, including major academic medical centers, pharmaceutical manufacturers and health plans. She also represented clients regarding federal fraud and abuse laws, including the False Claims Act, Stark Law, and Anti-kickback Statute.

Kristen also served on the staff of former Senator Max Baucus (D-MT) while he was Chairman of the Senate Finance Committee. Her work with the Senator focused on health and environmental issues, as well as financial reform.

Credentials

Education

J.D. cum laude from Georgetown University Law Center and her undergraduate degree from Cornell University

Bar Admissions

Washington D.C.
Massachusetts

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