Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel

Stephanie Trunk

Stephanie Trunk, Associate at Arent Fox
Stephanie Trunk
Partner
Washington, DC
202.857.6171

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.

 

Blog Posts by Stephanie Trunk

Prescription Drug Pricing & Government Price Reporting
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Pharma Industry Take Note: Maryland Passed Price-Gouging Prohibition
Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. Maryland has become the first state to do so – on May 26, 2017, Governor Larry Hogan of Maryland informed the Maryland Speaker of the House that he would permit H.B. 631, also known as the “Prohibition Against Price Gouging for Essential Off-Patent or Generic Drugs”(437th Gen. Assemb., Reg. Sess. (Md. 2017)) to become law. The Act takes effect October 1, 2017, and makes Maryland the first state in the nation to prohibit “price gouging” by manufacturers or wholesale distributors of generic prescription drugs. Of note, Governor Hogan did not sign the bill into law, rather he decided not to veto it, rendering the bill law after 30 days.
 
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Prescription Drug Pricing & Government Price Reporting
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Reminder to Generic Manufacturers: Q1 2017 Unit Rebate Amounts Billed by State Medicaid Programs Will NOT Include Additional Discounts

Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices (“AMPs”) of their products are rising faster than inflation when compared to a base line period. However, the Centers for Medicare & Medicaid Services (“CMS”) stated in April 14, 2017 e-mail correspondence to manufacturer technical contacts listed for the Drug Data Reporting for Medicaid System (“DDR”) that DDR system updates needed to automate the Additional Discount calculation on Non-Innovator products were not finalized in time and, as such, first quarter 2017 Unit Rebate Amounts for Non-Innovator products will NOT include the calculated Additional Discount, if any.

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E-Health, False Claims Act, Telemedicine & E-health
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Not Just for Health Care Providers Anymore: Health IT Vendor Pays $155 Million to Settle False Claims Act Case
Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million. This novel FCA settlement illustrates that health care fraud prosecution extends far beyond just the health care providers and payors that directly submit claims to Medicare, Medicaid and other federal health care programs, and can extend liability to subcontractors, agents, and vendors.
 

EHR Tech Must Meet “Meaningful Use” Standards

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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.