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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Insights
- Media CoverageRichard Hughes Quoted in “ACA Suit Threatens Overhaul of Preventive Care in Employer Plans”2 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court Case Offers Trump Path to Dismantle Obamacare Mandates”5 minute read
- Media CoverageRichard Hughes Quoted in “How RFK Jr. Drove Mistrust of a Cancer Prevention Vaccine”7 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Coverage Suit”4 minute read
- Media CoverageRichard Hughes Quoted in “Supreme Court to Hear ACA Preventive Care Case”1 minute read
- Media CoverageRichard Hughes Quoted in “Biden Admin Finalizes NBPP, MA Pay Rules Ahead of Departure”2 minute read
- Media CoverageRichard Hughes Quoted in “SCOTUS to Review ACA’s Free Preventative Services Mandate”2 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Case Presents Renewed Opportunity to Restrict Agencies”4 minute read
- PublicationsTop Ten Issues in Health Law 2025—Gender Affirming Care: 2025 Outlook4 minute read
- Media Coverage
Glenn Prives Featured in AHLA’s Speaking of Health Law Podcast, “Corporate Practice of Medicine: Latest Trends and ...
2 minute read - Media CoverageRichard Hughes Quoted in “RFK Jr. Could Reshape Vaccine Injury Program, Add Autism”2 minute read
- Media CoverageRichard Hughes Provides Historical Perspective on Vaccine Use in the 20th Century1 minute read
- PublicationsMedicare Coverage of Antiobesity Medicines1 minute read
- Media CoverageRichard Hughes Featured in “‘How Far Will RFK Go?’ 2 Experts Talk Kennedy’s Potential Impact on Child Health” ...4 minute read
- Media CoveragePhilo Hall Quoted in “A Medicare Minefield Awaits Oz”2 minute read
- Media CoverageHealth Podyssey: Richard Hughes, IV, on States’ Response to Federal Vaccine Recommendations for Schools1 minute read
- BlogsPodcast: Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care2 minute read
- Media CoverageRichard Hughes Explores the Impact of President-Elect Trump’s Nomination of Robert F. Kennedy Jr. as Secretary of Health ...13 minute read
- Media CoverageRichard Hughes Quoted in “Why the CDC May Look Very Different in Trump’s 2nd Term”2 minute read
- PublicationsTakeaways from State Votes on Abortion in the 2024 Election2 minute read
- Media CoverageRichard Hughes Quoted in “5 Ways Trump's Election Could Change Employee Benefits”2 minute read
- Media CoverageRichard Hughes Quoted in “FDA Science, Vaccine Policy to Face ‘Firm Hand’ in Trump Return”2 minute read
- Media CoverageDavid Shillcutt Quoted in “Trump's Win Endangers Slew of Biden-Era Employee Benefits Rules”2 minute read
- PublicationsNow Is Not the Time to Undo Adolescent Vaccination Policies2 minute read
- Media CoverageMark Lutes Quoted in “Trump Win Tees Up Regulatory Rollbacks and Uncertainty”3 minute read
- Media CoverageJohn Eriksen, Nivedita Patel Quoted in “DC Lawmakers Target 'Onerous' Certificate-of-Need Law”3 minute read
- Media CoverageRichard Hughes Quoted in “Scientists and RFK Jr. Want Vaccine Data—for Very Different Reasons”3 minute read
- PublicationsSchool-Entry Vaccine Policies: States’ Responses to Federal Recommendations Varied from Swift to Substantially ...5 minute read
- BlogsPodcast: Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – ...2 minute read
- PublicationsAre We Ready for a Bird Flu Vaccination Campaign?2 minute read
- PublicationsThe US Supreme Court and the Uncertain Future of Preventive Care4 minute read
- Media CoverageRichard Hughes Quoted in “Gov't Looks to High Court to Preserve Free Preventive Care”2 minute read
- BlogsVideo: New State Legislation Increases Oversight of Health Care Transactions – Thought Leaders in Health Law2 minute read
- Media CoverageRichard Hughes Quoted in “DOJ Asks SCOTUS to Reverse Braidwood Ruling, Uphold ACA’s Preventative Mandate” ...3 minute read
- Media CoverageKevin Malone Quoted in “Mental Health Parity Rule Pushes Employers to Rethink Status Quo”3 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- Media CoverageRichard Hughes Quoted in “CMS Signals Preventive Services Coverage Update with Pending Rule”3 minute read
- BlogsPodcast: Workplace Violence in Health Care: Dissecting the Legal Landscape and Implications for Employers – Diagnosing ...2 minute read
- BlogsPodcast: Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care2 minute read
- Media Coverage
Richard Hughes Quoted in “DOJ Will Ask SCOTUS to Take Up Braidwood”
3 minute read - Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- Media CoverageDavid Shillcutt Quoted in “Illinois Bans Step Therapy, Health Plan Prior Authorization for Emergency Mental Health ...3 minute read
- Media CoverageHelaine Fingold Quoted in “MAOs, Brokers, Agents Get Relief with Legal Pause on Policy Changes”2 minute read
- BlogsPodcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care2 minute read
- Media CoverageRichard Hughes, Raja Sékaran Quoted in “‘Chaotic’ Health Care Rulemaking Looms After Supreme Court Hamstrings ...3 minute read
- Media CoverageHelaine Fingold Quoted in “Court Pauses CMS Broker Compensation Rule for Medicare Advantage Plans”3 minute read
- Media CoverageMandated Coverage of Biomarker Testing: Q&A with Robert Hearn4 minute read
- PublicationsVaccine Politics4 minute read
- Media Coverage
Robert Wanerman Quoted in “Health Regulators Likely to Tread Carefully Post-Chevron”
2 minute read - PublicationsBraidwood v Becerra: The Threat to Preventive Services Just Got Worse3 minute read