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, Kristin represents clients in litigation at the trial and appellate levels, primarily in matters involving allegations of fraud and abuse against government healthcare programs.
Experience
- Represented Pharmaceutical Research and Manufacturers of America (PhRMA) in a successful Administrative Procedure Act challenge to a CMS regulation that would have required drug manufacturers to account for co-pay assistance in Medicaid rebate calculations unless they took steps to “ensure” insurers did not apply accumulator adjustment systems. PhRMA v. Becerra (D.D.C.).
- Represented 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.).
- Represented 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.).
- Represented 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.
- Counsel pharmaceutical manufacturers regarding implementation of the Inflation Reduction Act of 2022.
- 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.
Perspectives
September 26, 2024
Regulatory and Compliance Hot Topics for West Coast Life Sciences Companies
Arnold & Porter Conference
February 16, 2024
Navigating the Pending BIOSECURE Act: Implications for U.S.-China Biopharmaceutical Collaboration and National Security
Advisory
October 14, 2022
Fireside Chat: External Counsel Roundtable
Speaker, Medicaid Drug Rebate Program (MDRP) Summit 2022
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Recognition
LMG Life Sciences Guide
"Life Science Star" Healthcare Pricing & Reimbursement (2022, 2024)
The Legal 500 US
"Next Generation Partner" Healthcare: Life Sciences (2020-2024)
Healthcare: Life Sciences (2021-2022)
Healthcare: Service Providers (2018)
Healthcare: Life Sciences (2021-2022)
Healthcare: Service Providers (2018)
Washington, DC Super Lawyers
"Rising Star"–Health Care (2016-2022)
Credentials
Education
- J.D., Harvard Law School, 2008, cum laude
- A.B., Harvard College, 2005, magna cum laude
Admissions
- District of Columbia
- Virginia