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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 December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain electronic health transactions.  Specifically, the proposed rule would adopt standards for health care attachment transactions (e.g., medical charts, x-rays, provider notes) and electronic signatures to be used in conjunction with health care attachments, and modify the standard for referral certification and authorization transaction.  The proposed rule would apply to entities regulated by the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”), and would implement certain requirements of the Administrative Simplification subtitle of HIPAA and the Patient Protection and Affordable Care Act (“ACA”) that require the Secretary of HHS to adopt and update standards for electronic health transactions, code sets, unique identifiers, as well as the electronic exchange for health information.

Continue Reading HHS Proposes Rule to Improve Standards for Electronic Prior Authorizations and Other Transactions with Health Care Attachments

Practice Fusion, Inc. (Practice Fusion), an electronic health record (EHR) vendor acquired by Allscripts in 2018, recently agreed to pay $145 million to resolve criminal and civil investigations related to an illegal kickback arrangement with a major opioid company.

The settlement included $26 million in criminal fines and forfeiture to
Continue Reading EHR Vendor Admits to Soliciting and Receiving Kickbacks in Exchange for Promoting Prescription Opioids