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 “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
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- 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
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- 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
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- 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
- Media Coverage
Richard Hughes Quoted in “Supreme Court Overrules Chevron Deference, Dealing Blow to Federal Healthcare Agencies” ...
3 minute read - Media CoverageRichard Hughes Quoted in “Feds' 5th Circ. Win on Preventive Care May Imperil ACA”3 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Mandate Battle Shifts After Appeals Court Speaks”3 minute read
- Firm Announcements
Elizabeth Scarola Named to the 2024 Florida Rising Stars List
7 minute read - Media CoverageRichard Hughes Quoted in “Court Upholds ACA’s Free Preventive Services Mandate”3 minute read
- Media CoverageRichard Hughes Quoted in “News Briefs: Court Upholds ACA Preventive Services Coverage Mandate, for Now”2 minute read
- Media CoverageRichard Hughes Quoted in “‘A Mixed Bag’: Fifth Circuit Rules on ACA Preventive Services Legal Case”3 minute read
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- Media CoverageJohn Puente Featured in “People on the Move”1 minute read
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- Media Coverage
Lisa Gora Featured in AHLA’s Speaking of Health Law Podcast, “The Psychedelics Boom in the Health Care Industry ...
1 minute read - PublicationsFood Is Medicine: The Road to Universal Coverage2 minute read
- BlogsUpdated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams4 minute read
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- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read