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Stefanie Doebler

Stefanie Doebler leads the firm's Health Care Practice Group and is a member of the Food, Drug, and Device Practice Group. She has more than 20 years of experience counseling on health care compliance matters for pharmaceutical, biotech, medical device, and technology clients. She provides pre- and post-market advice related to advertising and promotion, fraud and abuse, digital health, and telehealth. Stefanie also advises on the development and implementation of health care compliance programs and helps clients conduct internal reviews, compliance audits, and risk assessments. Clients say that Stefanie’s advice is practical and solution-oriented. Her work for a broad range of life sciences clients, ranging from start-ups to multinationals, gives her unique insights into industry practices and benchmarking.

Stefanie regularly interacts with Boards of Directors and senior leadership on health care compliance matters in connection with high-stakes strategic matters. She is recognized by clients as a true partner—developing a deep knowledge of their business priorities, operational challenges, competitive pressures, and risk tolerance.

Stefanie works closely with colleagues in other practice areas, such as privacy, government contracts, antitrust, and tax to provide cross-functional assistance to clients and to help anticipate how changes to the law and enforcement landscape could affect their activities. She collaborates with life sciences litigation colleagues to conduct investigations and respond to government inquiries. She also leads health care compliance diligence for complex transactions, including mergers and acquisitions, joint ventures, and public offerings, and she assists with licensing transactions for development and commercialization.

Stefanie counsels in-house counsel and their business partners to ensure that their activities comply with the Federal Anti-Kickback Statute and the Federal False Claims Act; other fraud and abuse laws including the Beneficiary Inducement Act, the Eliminating Kickbacks in Recovery Act, the federal health care program exclusion laws, and similar state laws; the Federal Food, Drug, and Cosmetic Act and FDA’s requirements for medical product advertising; state practice of medicine laws, including corporate practice of medicine and telehealth; state pharmacy laws; price reporting requirements for the Medicaid Drug Rebate Program and Medicare Part B; and the Sunshine Act and state transparency laws.

Stefanie is an avid reader, devouring between 60 and 90 books a year--primarily contemporary literature, historical fiction, and mystery and thrillers. She loves to trade book recommendations with clients.

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs. HB 4005 also imposes new reporting requirements on health insurers and establishes a temporary task force charged with developing “a strategy to create transparency for drug prices across the entire supply chain of pharmaceutical products.”[1]
Continue Reading Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers