In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug Pricing Program. Arent Fox’s Health Care Counsel Blog previously featured an analysis of the Final Rule, which can be found here.
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.
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.
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.
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.
Blog Posts by Stephanie Trunk
In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness. Although DOJ points out that the publication is “neither a checklist nor a formula,” the document provides practical guidance to corporations (and their attorneys) about where DOJ will focus its compliance program inquiries. And although the publication applies only to the criminal division, it may be instructive in civil fraud matters as well.
Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs. The portfolio features planned work, completed reports, industry guidance, and enforcement actions.”
ABOUT ARENT FOX LLP
Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.