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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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.
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- PublicationsMeasles Cases Top 1,000: A Crisis of Complacency2 minute read
- Media CoverageRichard Hughes Quoted in “States Loosen Vaccine Rules — Even as Measles Outbreak Rages”8 minute read
- Media Coverage
Richard Hughes Featured in Healthcare Matters, “Immunization at a Crossroads: Experts Weigh In from the World Vaccine ...
4 minute read - Media CoverageRichard Hughes Quoted in “Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters” ...2 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.’s Latest Vaccine Plan Threatens Future of Shots, Experts Say”2 minute read
- PublicationsNewborn Screening at Risk: Implications of Disbanding the Advisory Committee on Heritable Disorders in Newborns and ...2 minute read
- PublicationsThe Future of Preventive Care Depends on the Supreme Court’s Reading of Two Words2 minute read
- BlogsA Common Denominator Governs the Medicare Fraction - SCOTUS Today5 minute read
- Media CoverageRichard Hughes Quoted in “SCOTUS Weighing Braidwood Appointments Clause Violation in Briefs Request”2 minute read
- Media CoverageRichard Hughes Quoted in “Survival of Preventive Care Coverage Mandate Would Boost Some Health Care Firms”2 minute read
- Media CoverageRichard Hughes Quoted in “Why Journalists Need to Explain the Value of No-Cost Preventive Care”7 minute read
- BlogsPodcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care2 minute read
- Media CoverageRichard Hughes Quoted in “Experts: Look to States and the Courts for Shifts in Vaccine Policy”5 minute read
- Media CoverageWilliam Walters Quoted in “Ruling Could Give Kennedy More Power Over Health Care Coverage”4 minute read
- Media CoverageRichard Hughes Quoted in “ACA Preventive Care Case Reaches Supreme Court”4 minute read
- Media Coverage
What's at Stake as Oral Arguments Are Presented in the Braidwood Case? Q&A with Richard Hughes, IV
4 minute read - Media CoverageRichard Hughes Quoted in “Supreme Court Grapples with Challenge to ObamaCare Preventive Care Panel”6 minute read
- Media CoverageWilliam Walters Quoted in “Supreme Court Appears Willing to Save ACA Preventive Services Task Force”3 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear Challenge to Obamacare Rule on Free Preventive Care”4 minute read
- Media CoverageRichard Hughes Quoted in “‘At the Mercy of Insurance Companies’: Supreme Court Braces for ACA Preventive Coverage ...4 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr. Attacks Environmental Toxins as Cause of Childhood Autism 'Epidemic', Stays Silent on ...8 minute read
- Media CoverageRichard Hughes Quoted in “On Autism, Experts Worry Kennedy May Pivot Back to Vaccine Claims”2 minute read
- Media CoverageRichard Hughes Quoted in “States Echo RFK Jr. Agenda in Push for Ban on Vaccine Mandates”2 minute read
- PublicationsVaccine Advisory Committee Meetings Resume: What Lies Ahead?3 minute read
- BlogsPodcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care2 minute read
- Media CoverageRichard Hughes Quoted in “Idaho Restricts Vaccine Mandates”3 minute read
- BlogsPodcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care2 minute read
- Media CoverageRob Wanerman Quoted in “HHS Reorganization Raises Questions for Claims Appeals Process”1 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Weigh Medicaid Cutoff for Planned Parenthood”2 minute read
- Media CoverageRichard Hughes Quoted in “How RFK Jr. Could Threaten Vaccine Markets”5 minute read
- Media CoverageRichard Hughes Quoted in “USPSTF Taps New Chair, Vice Chair; Quiet on Potential Changes”2 minute read
- Media CoverageRichard Hughes Quoted in “Experts See Potential for RFK Jr. to Make Major Changes to ACIP”2 minute read
- Media Coverage
Jenny Nelson Carney Featured in AHLA’s Speaking of Health Law Podcast, “Top Ten 2025: Gender Affirming ...
2 minute read - Media CoverageHelaine Fingold Quoted in “MedPAC Members Will Hear Out Agents, Brokers After Slamming `Flawed System’”2 minute read
- Media CoverageRob Wanerman Quoted in “Payers to Lose Clear Communication Channel with Repeal of HHS Public Comment Period” ...2 minute read
- PublicationsUS Courts Health Disaster as It Drops the Ball on Flu Preparedness2 minute read
- Media CoverageKate Heffernan Featured in “Can NIH Overturn a Court Order Blocking It from Slashing Overhead Payments? Unlikely, One ...5 minute read
- Media CoverageKate Heffernan, Robert Wanerman Quoted in “HHS Comment Reversal Sets Stage for Quick Policy Changes”2 minute read
- Media CoverageSarah M. Hall Quoted in “Criminal Health Care Fraud Enforcement Expected to Remain Robust”2 minute read
- PublicationsACIP’s Upcoming Meningococcal Recommendations: Added Complexity, Reduced Choice1 minute read
- Media CoverageRachel Snyder Good Quoted in “URAC Introduces Health AI Accreditation as Federal Regulations Lag Behind”3 minute read
- Media CoverageRichard Hughes Quoted in “CDC Plans Study on Vaccines and Autism Despite Research Showing No Link”4 minute read
- Media CoverageRichard Hughes Quoted in “Trump’s FDA Nominee Grilled on Vaccine Meeting, Agency Staffing”8 minute read
- Media CoverageRichard Hughes Quoted in “Kennedy's Early Warning Signs on Vaccine Policy”4 minute read
- BlogsSitting Atop a Telehealth Cliff?4 minute read
- PublicationsExpanding Vaccination Provider Types and Administration Sites Can Increase Vaccination Uptake: A Systematic Literature ...2 minute read
- Media Coverage
Richard Hughes Discusses Why Payer Responsibility for Preventative Services May Hinge on Braidwood Management Inc. v ...
4 minute read - Media CoverageRichard Hughes Quoted in “Expert: Removing Shots from Childhood Schedule Would Nix Compensation”2 minute read
- Media CoverageRichard Hughes Quoted in “F.D.A. Cancels Meeting of Vaccine Experts Scheduled to Advise on Flu Shots”2 minute read
- Media CoverageRichard Hughes Quoted in “Could ACIP Delay Wind Up in Court?”2 minute read