Jen Madsen, MPH, has built her expertise in health policy and the life sciences over nearly two decades in Washington, DC. She counsels clients on regulatory, coverage, and reimbursement issues in the emerging field of precision medicine. Ms. Madsen’s clients include clinical laboratories, manufacturers of pharmaceuticals and in vitro diagnostics, healthcare information technology companies, issue-based coalitions, investors, trade associations, and medical specialty societies.
Her practice includes analyzing Federal and state legislation, Medicare regulations and demonstration programs, guidance from the Food and Drug Administration, and health insurer policies. She works with clients to develop comment letters, build relationships with key stakeholders, engage with policymakers, and shape the policy environment to support their strategic objectives.
Prior to joining the firm, Ms. Madsen was Sr. Director for Economic and Regulatory Affairs at the College of American Pathologists, the accreditor of genomic sequencing laboratories and medical specialty society. She led a team of ten professional staff responsible for regulatory, coverage, and payment policy issues. She was previously Vice President for Policy and Regulatory Affairs at the American Clinical Laboratory Association, where she led user fee negotiations with the FDA on laboratory-developed tests and partnered with the American Medical Association on the development of new CPT codes for molecular diagnostic tests.
During negotiations leading up to the passage of the Affordable Care Act, Ms. Madsen was a principal at a prominent bipartisan lobbying firm where she advised healthcare providers, health insurers, and large employers.
From 2003 to 2009, Ms. Madsen held a series of progressively responsible leadership roles at a health policy consulting firm during its growth from a startup to an industry leader. She counseled pharmaceutical manufacturers, patient advocacy groups, and trade associations on the implementation of the Medicare prescription drug benefit.
Early in her career she was a health economist with the nonpartisan Congressional Budget Office, a staff agency of the US Congress, where she was responsible for scoring legislation on preventive benefits, mental health parity, and Medicare drug coverage.
- MPH, Yale University, 1999
- BA, Biochemistry, Rice University, 1997
- *Not admitted to the practice of law
Associate Analyst, Health and Human Resources Division, Congressional Budget Office, US Congress
Member, American Association of Medical Society Executives
Member, Women in Government Relations
Member, Public Policy Committee, Personalized Medicine Coalition
Member, Association for Molecular Pathology
Member, International Society for Pharmacoeconomics and Outcomes Research