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Keeping you afloat amidst the rising sea of regulations

Stephanie Trunk

Washington, DC
Stephanie Trunk

Stephanie Trunk

Washington, DC

Stephanie is a partner in the Health Care practice. She focuses her practice on counseling pharmaceutical and device manufacturers, distributors and their customers, including pharmacy benefit managers, on regulatory, reimbursement and compliance matters. Her practice extends to counseling on drug pricing and government price reporting, HIPAA and privacy matters, counseling on Medicare Part D, developing corporate compliance programs, representing clients in contract negotiations and providing transactional support to her clients.

Client Work

Stephanie represents pharmaceutical manufacturers of both pioneer and generic drugs, wholesale distributors of prescription drugs and devices, and pharmacy benefit management companies. Her recent work has included:

  • Developing a training program on government price reporting, including ASP, AMP and Best Price, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program and non-FAMP and FCP reporting to FA/FSS for a pharmaceutical manufacturer.
  • Drafting proposed comments to Medicare Part D regulations proposed by CMS for various interested stakeholders.
  • Assisting a device manufacturer in assessing fraud and abuse risks associated with contemplated sales and marketing activities and promotional or educational programs.
  • Auditing a patient assistance foundation.
  • Counseling a health system regarding the implications of the “own use” doctrine on a planned business arrangement.
  • Drafting and negotiating HIPAA Business Associate Agreements for various clients, including an electronic health records vendor.
  • Drafting annual compliance training for a pharmacy benefit management company and a medical device manufacturer.
  • Reviewing and updating rebate agreements for a pharmaceutical company.
  • Drafting distribution agreements for a device manufacturer.

Previous Work

Prior to joining Arent Fox, Stephanie was legal counsel to a pharmacy benefit management company where she provided legal guidance to the company on a variety of matters, including: Medicare Part D, HIPAA and privacy, corporate compliance, fraud and abuse, and licensing/regulatory. Additionally, upon completion of law school, Stephanie was an associate in the DC office of a leading national law firm, where she primarily counseled pharmaceutical and device manufacturers on both reimbursement and fraud and abuse matters.

Prior to attending law school, Stephanie practiced as a Certified Public Accountant in the assurance and advisory business services division of a national accounting firm, primarily providing auditing services to entities throughout the health care industry.

Professional Activities

Stephanie is a member of the American Health Lawyers Association and the American Bar Association’s Health Law Section.

Publications, Presentations, and Recognitions

Stephanie is the co-author of a book chapter on Controlling Fraud, Waste and Abuse in the Medicare Part D Program, published in the ABA’s Health Care Fraud and Abuse: Practical Perspectives, edited by Linda A. Baumann, published by the American Bar Association Health Law Section and BNA.

While in law school, Stephanie was a member of the George Washington University Law Review, where she published the following articles:

  • “Agency Interpretation of the Medicaid Statute: When Does It Deserve Deference?” 70 Geo. Wash. L. Rev. 405 (2002).
  • “Sounding the Death Toll for Health Care Providers: How the Civil False Claims Act has a Punitive Effect and Why the Act Warrants Reform of its Damages and Penalties Provision.” 71 Geo. Wash. Rev. 159 (2003).

She was also elected to the Order of the Coif and is the 2003 Recipient of the Excellence in Health Law Award from the American Bar Association Health Law Section and Bureau of National Affairs.

Life Beyond the Law

When not working, Stephanie enjoys spending time, especially outdoors, with her husband and 2 children and cheering on the Baltimore Ravens.