Kristin Hicks' practice focuses on counseling and litigation for clients in the pharmaceutical and medical device sectors. Her work includes advising clients regarding government price reporting, fraud and abuse compliance, federal contracting requirements, and legislative and public policy issues. In addition, Ms. Hicks represents clients in litigation at the trial and appellate levels, primarily in matters involving allegations of fraud and abuse against government healthcare programs.

As a student at Harvard Law School, Ms. Hicks was the Executive Editor of the Harvard Journal of Law & Technology and a member of the Board of Student Advisors. Ms. Hicks earned her undergraduate degree from Harvard College, where she majored in neurobiology and was the captain of the women's lightweight crew team.

Experience

  • Pharmaceutical Research and Manufacturers of America (PhRMA) in a successful Administrative Procedure Act challenge to the Health Resources and Services Administration's interpretation of the orphan drug exclusion from 340B drug pricing obligations. PhRMA v. HHS (D.D.C.).
  • AstraZeneca in drug pricing litigation involving the 340B drug discount program, winning a favorable ruling by the Supreme Court that such lawsuits could not proceed. County of Santa Clara v. Astra USA, Inc. (Supreme Court; 9th Circuit; N.D. Cal.).
  • Pharmaceutical Research and Manufacturers of America (PhRMA) before the Supreme Court in a successful First Amendment challenge to a Vermont law restricting the rights of drug manufacturers to promote their products using prescriber data. Sorrell v. IMS Health, Inc. (Supreme Court; 2d Circuit; D. Vt.).
  • Served on secondment to the in-house legal or compliance departments of three major pharmaceutical and medical device manufacturers.
  • Advise pharmaceutical manufacturers on drug pricing issues under the 340B program, Medicaid, Medicare, TRICARE, and the Department of Veterans Affairs healthcare program; prepare drug price reporting policies and reasonable assumptions; provide guidance on internal audits and price recalculation projects.
  • Counsel pharmaceutical and medical device manufacturers on compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Statute and the False Claims Act.
  • Advise pharmaceutical and medical device manufacturers on federal contracting requirements, including compliance with the Trade Agreements Act, solicitation and contract clauses, and certification and reporting obligations.
  • Draft comments to CMS and other HHS agencies on behalf of drug and medical device manufacturers and industry associations on proposed rules and guidance regarding reimbursement and price reporting issues.
  • Counsel pharmaceutical and medical device manufacturers regarding implementation of the Affordable Care Act.

Perspectives

Life Science Transactions: Getting to a Successful Deal
Arnold & Porter Seminar, Cambridge, MA
Fireside Chat: Explore Operational Challenges and Proven Approaches to Better Manage Restatement Strategies
World Congress 2nd Annual Manufacturers' 340B Summit, Philadelphia, PA
Regulatory Think Tank: Implications of the Civil Monetary Penalties Final Rule and Its Impact on 340B
World Congress 2nd Annual Manufacturers' 340B Summit, Philadelphia, PA
Trump Administration Issues Blueprint to Lower Drug Prices and Reduce Out-Of-Pocket Costs
Advisory
Successful Strategies for Achieving Positive Results Related to Domestic and International Formulary Determinations
ACI Forum on Health Outcomes, Data Communications, Market Access, and Value Based Contracting, Philadelphia, PA
More

Recognition

The Legal 500 US
Healthcare: Service Providers (2018)
Washington, DC Super Lawyers
"Rising Star" – Health Care (2016-2018)

Credentials

Education
  • JD, Harvard Law School, 2008, cum laude
  • AB, Harvard College, 2005, magna cum laude
Admissions
  • District of Columbia
  • Virginia
Overview

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