Covington & Burling LLP operates as a limited liability partnership worldwide, with the practice in England and Wales conducted by an affiliated
limited liability multinational partnership, Covington & Burling LLP, which is formed under the laws of the State of Delaware in the United States
and authorized and regulated by the Solicitors Regulation Authority with registration number 77071..
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.
Advised a large pharmaceutical company on a first-of-its-kind direct-to-patient platform, including telehealth, home delivery, and physician locator services.
Advised pharmaceutical and biotech clients with respect to the full range of product support programs, including financial assistance, hub services, reimbursement support, travel assistance, and injection training.
Assisted rare disease company with a product launch, including review of the product’s promotional campaigns, outreach to health care professionals, and patient programs.
Obtained a favorable advisory opinion regarding a sponsored testing program for a companion diagnostic test.
Counseled pharmaceutical company on listing its drugs for sale on TrumpRx and related issues.
Conducted a global risk assessment for a large company with medical device, pharmaceutical, and nutrition business units.
Assisted a gene therapy company in creating and implementing new field roles to provide site onboarding services.
Advised a medical device company on novel contracting arrangements, including bundled discounts and market share rebates.
Counseled pharmaceutical company on electronic health record solutions, including clinical decision support tools.
Assisted a tech company regarding a proposal to provide AI-generated health information via an online platform.
University of Michigan School of Public Health, M.P.H., 2004
Carnegie Mellon University, M.A., 1998
Northwestern University, B.A., 1997
with honors
Bar Admissions
District of Columbia
Pennsylvania
Judicial Clerkship
Hon. Ronald Lee Gilman, U.S. Court of Appeals, Sixth Circuit, 2004 - 2005
Pro Bono
Representation of a local non-profit organization in legislative and regulatory efforts to ensure that the regional affiliate of a national insurance company fulfills its charitable health care obligation to the National Capital Area.
Assistance to dual-eligible individuals regarding their Medicare prescription drug benefits.
Accolades
Washington DC Super Lawyers, FDA "Rising Star" (2014-2015)
Klepper Prize for Volunteer Excellence, Legal Aid Society of the District of Columbia (2014)
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