Liz Lindquist counsels life sciences industry stakeholders on a broad range of regulatory, compliance, transactional, investigation, litigation, and legislative issues involving federal and state government healthcare agencies and enforcement authorities. Her practice focuses in substantial part on advising clients on pharmaceutical market access, drug price calculation and reporting, and state law matters.
Liz has represented numerous clients in a wide variety of federal procurement and contracting matters, including extensive work pertaining to the U.S. government’s invocation of the Defense Production Act (DPA) and use of other emergency contracting procedures. Liz is also well versed in federal and state “Buy American” (i.e., domestic preference) and “Most Favored Nation” drug pricing policies and initiatives, developing and implementing clients’ government-advocacy, compliance, and litigation strategies related to such proposals.
Experience
- Advise pharmaceutical and biotechnology manufacturers on the ever-evolving landscape of drug pricing issues related to federal healthcare programs, including the 340B Drug Pricing Program, Medicaid Drug Rebate Program, Medicare Parts B and D, U.S. Department of Veterans Affairs Federal Supply Schedule Program, the TRICARE Retail Refund Program, discarded drug refunds, and state-specific drug pricing and supplemental rebate regimes.
- Assist in the development and implementation of government price calculation and reporting policies, procedures, systems, methodologies, and reasonable assumptions, and advise clients on an ongoing basis regarding changes to legal authorities (including, among others, the Medicare rebate program and drug price negotiation provisions of the Inflation Reduction Act of 2022 and AMP cap removal.
- Provide guidance on internal audits of drug price calculation and reporting practices and assist with related recalculation and reconciliation of historic pricing, including coordination among affected government programs.
- Advise clients regarding market entry and portfolio management, bona fide service fee analyses, potential government program liability under commercial contracting and discounting arrangements, bundling identification and allocation, class of trade assignment, inclusion/exclusion determinations, and other complex government pricing requirements and considerations.
- Support clients in interactions with the U.S. Department of Justice, Centers for Medicare & Medicaid Services, Health Resources and Services Administration, U.S. Department of Health and Human Services Office of Inspector General, and the U.S. Department of Veterans Affairs Office of Inspector General, and in connection with state prescription drug affordability board (PDAB) reviews and assessments.
- Counsel life sciences companies on a variety of state laws, including drug price transparency, aggregate spend, gift ban, sales representative licensing/registration, and drug and sharps disposal (i.e., “take-back” obligations).
- Assist life sciences and manufacturing clients with government advocacy efforts to secure funding and legislative and policy changes to facilitate expansion of domestic manufacturing operations.
- Draft comments to HHS and other executive branch agencies and state government agencies on behalf of pharmaceutical, medical device, and biotechnology manufacturers regarding proposed rules and guidance.
- Advise life sciences companies on the operation and application of the Defense Production Act, compliance issues and commercial considerations associated with Defense Production Act contracts and rated orders, including the implications of Defense Production Act invocation on supplier relationships and strategic supply chain and business impact planning, and the intersection between U.S. Food and Drug Administration regulatory requirements, federal contracting obligations, and Defense Production Act contracts and rated orders.
- Obtained with co-counsel the dismissal of a qui tam lawsuit brought by a relator alleging that a pharmaceutical manufacturer client avoided its obligation to return nearly $19 million in Medicaid Drug Rebate Program overpayments to the federal government, in violation of the False Claims Act.
- Assisted a medical device manufacturer with the negotiation, execution and implementation of a $25.4 million contract awarded by the US Department of Health and Human Services under the Defense Production Act for thousands of ventilators during the COVID-19 pandemic.
- On behalf of a pharmaceutical company client, successfully challenged a U.S. Department of Veterans Affairs Office of Inspector General finding of $3.2 million in overcharges related to non-Trade Agreements Act-compliant pharmaceutical products sold to federal government agencies, with the government absolving the alleged overcharges in their entirety.
- Assisted a pharmaceutical manufacturer client temporarily stay termination from the Medicaid Drug Rebate Program, achieving this uncommon result by navigating highly complex legal and operational obstacles.
- Together with co-counsel, secured from the Centers for Medicare & Medicaid Services a unique and unprecedented resolution of a critical Medicaid Average Manufacturer Price issue for a pharmaceutical manufacturer client estimated to save the client more than $40 million over the life of its product.
- Served as the government contracts subject matter expert for a client’s $600 million acquisition of a company with significant revenue tied to federal contracts; managed all aspects of the diligence related to federal contracting compliance obligations, risks and post-transaction requirements and drafted relevant terms for the applicable deal documents.
- Together with co-counsel, advised CVC Capital Partners on its $925 million acquisition of the Therakos business from pharmaceuticals company Mallinckrodt Pharmaceuticals plc.; the transaction was recognized with the “Private Equity Deal of the Year honor at the IFLR Americas Awards (which aims to highlight “the most innovative cross-border deals closed in the region in 2024”).
Perspectives
Recognition
Credentials
Education
- J.D., Saint Louis University, 2009
- B.A., Biology and History, with honors, Williams College, 2005
Admissions
- Colorado
- District of Columbia
- New York