Overview
Health care and life sciences companies face substantial challenges within the ever-evolving health policy and legislative landscape.
Complex regulations, funding fluctuations, shifting legislative priorities, and intricate policy frameworks can profoundly affect a health care or life sciences company’s operations, growth, and bottom line.
At Epstein Becker Green, we are committed to offering strategic guidance and tailored solutions to help health care and life sciences companies successfully navigate the intricate maze of health policy and legislation. For decades, we have represented health care and life sciences clients before Congress and federal and state agencies, advocating for policies aligning with our clients’ mission, values, and priorities. We offer the critical insight and analysis necessary to help health care and life sciences stakeholders determine areas of potential risk, as well as future opportunities.
Our Team Sets Us Apart
Our Health Policy and Legislation team includes seasoned health care and life sciences attorneys, several of whom previously held prominent government positions—including as Acting Administrator for the Centers for Medicare & Medicaid Services (CMS), as Counselor to the Secretary of the U.S. Department of Health and Human Services (HHS), as Senior Policy Advisor to the Majority Leader of the U.S. House of Representatives, as a legislative advisor to the Federal Trade Commission (FTC), and as a State Senator in the Connecticut General Assembly. Our team also includes veterans from our public policy and legislative advocacy affiliate National Health Advisors, who have exceptional and critical experience navigating proposed legislation and agency regulation.
In addition, members of our team have been called upon to provide technical guidance to Congress and federal agencies on health care issues. For example, we have provided testimony on health care issues at the invitation of the U.S. Senate Committee on the Judiciary, the House Committee on Oversight and Government Reform, the FTC, and the U.S. Department of Justice, among other government entities.
Services to Meet Your Needs
Our Health Policy and Legislation team advises on the full range of policy issues and legislation affecting the health care and life sciences industries. We have served as legislative advocates for players across those industries—including hospitals and health systems, insurers, managed care plans, medical device manufacturers, pharmaceutical and biotechnology companies, pharmacies, physician groups, trade associations, issue-specific coalitions, and investors—in matters pending before Congress and other federal and state agencies. Clients benefit from our team’s insight into the legal, policy, budgetary, and political factors influencing federal agency decision-making and our ability to cut through the bureaucracy and communicate with key decision-makers and policymakers.
Our comprehensive health policy and legislative services are strategically focused on our clients’ advocacy needs. These services include the following:
- Representing clients before Congress, federal agencies, state legislatures, state agencies, and other health policy influencers
- Analyzing the impact of current and pending federal and state legislation and regulations on client operations
- Developing public policy positions on client matters
- Drafting client testimony and preparing clients for congressional testimony
- Providing legal analyses of the impact of federal and state legislation on corporate structures and reimbursement
- Briefing investor clients on portfolio company risks associated with current and pending federal and state regulations
- Developing amendments to pending federal and state legislation
- Coordinating client issues with professional and trade associations
- Preparing testimony and appearing on behalf of clients before congressional committees
- Developing coalitions supporting policy issues
- Coordinating client meetings with federal and state officials
- Advising clients on health care and life sciences industry trends and relevant federal and state health policy developments
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Focus Areas
Services
Industries
Experience
- Analyzed and forecasted for a leading health care private equity investor the likely regulatory and legislative changes that could impact each of its portfolio companies, and recommended action steps to address its specific risks and opportunities.
- Developed national and state policy strategies for vaccine and other biopharmaceutical manufacturers, and advised clients on strategies for engaging state and federal agencies, including the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention (CDC), CMS, and the Biomedical Advanced Research and Development Authority.
- Provided a long-term care and home health company with an outlook and analysis of federal and state legislative and regulatory trends that could impact reimbursement, coverage, and coding.
- Analyzed for a leading investment firm the impact of the 2020 elections on federal health policy, specifically focusing on anticipated regulatory and legislative drug pricing reforms and trends in pharmaceutical value-based payment models.
- Developed, for a diagnostic manufacturer, a policy agenda designed to educate policymakers in Congress and federal agencies on the value of biomarker-based genetic tools for cancer screening.
- Advised or engaged the White House, HHS, CDC, and Congressional offices on vaccine policy development.
Contacts
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Media
Events
Past Events
- September 13-15, 2023
Insights
Insights
- BlogsPodcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care2 minute read
- PublicationsBraidwood v Becerra’s Vaccine Access Threat3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2024 Promotions6 minute read
- Media CoveragePaving the Way for Prevention Over the Counter3 minute read
- PublicationsQuadrivalent Vs Trivalent Influenza Vaccines: Not A Simple Switch2 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom” ...2 minute read
- PublicationsVaccines in the Courts: A COVID-19-Induced Litigation Influx2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI Has Arrived in Your Doctor’s Office. Washington Doesn’t Know What to Do About ...4 minute read
- Media CoverageRichard Hughes Quoted in “Coverage, Supply Issues Dampen Promise of New RSV Immunizations”3 minute read
- Media CoverageRichard Hughes Quoted in “An R.S.V. Shot for Infants Is in Short Supply. Here’s What to Know”4 minute read
- PublicationsPreventive Antibody Products Are Immunizations2 minute read
- Media CoverageRichard Hughes, Will Walters Quoted in “SCOTUS Cases Could Create ‘Fractured’ Health Care Policy Landscape” ...2 minute read
- PublicationsCalifornia Enacts Statute That Furthers Efforts to Move Toward a Unified Health Care Financing System11 minute read
- Media CoverageRichard Hughes Quoted in “RSV Vaccines Aren’t Covered by Medicare for These Vulnerable Groups”2 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read