Panoramic: Automotive and Mobility 2025
Health Legislation and Policy
The process by which U.S. federal legislation affecting the health industries is enacted is complex and often counterintuitive. That is why effective participation in the legislative process often requires hands-on experience on Capitol Hill and in the administrative agencies, in addition to in-depth knowledge of health care services and delivery. With a practice that includes a former member of the U.S. Congress, numerous former congressional and agency senior staff, former in-house lobbyists for the largest provider and pharmaceutical trade associations in Washington, and significant experience in health care-related law and business, we help clients navigate their way through the labyrinth by which federal law and policy are established.
On issues such as regulation of the pharmaceutical and biotechnology industries, Medicare and Medicaid reform, digital health and artificial intelligence, requirements and restrictions involving clinical research, medical liability, long-term care, public health, and patient privacy, we work with clients to construct and carry out strategies for communicating their point of view and participating in the legislative and administrative processes by which federal laws are enacted and policies are established. We are bipartisan in our approach, maintaining strong relationships with lawmakers and committee staff on both sides of the aisle, and regulatory officials in both Republican and Democratic administrations. On Capitol Hill and in the agencies, our government affairs professionals are respected for their deep knowledge of health law and policy, their experience with legislative and administrative processes, and their ability to clearly and effectively advocate in that context on their clients' behalf.
Often clients rely on us to augment their in-house government relations capabilities by keeping them informed of developments and helping them understand the genesis and likely effects. For a number of clients, we closely watch health-related legislation and regulatory activity, draft comments on proposed rules, and provide regular updates. For health care associations, we provide representation in the U.S. Congress on legislative matters and before executive agencies on regulatory and rulemaking issues. For example, as Congress worked to write new Medicare prescription drug legislation, we worked with several clients to include language vital to their businesses.
Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Key contacts
Representative experience
Secured US$10m in Title VII funding for pediatric dentistry residency and loan repayment programs on behalf of the American Academy of Pediatric Dentistry.
Assist a client in obtaining funding for eye and vision research in the defense appropriations bill resulting in over US$20m in the last six fiscal years.
Secured an exemption from a drug pricing provision of the Inflation Reduction Act for a manufacturer client.
Lead a multi-company coalition to advance payment for medical device and pharmaceutical artificial intelligence (AI) systems.
Manage a government affairs campaign on behalf of a national trade association representing hundreds of hospital and health systems to modify provisions of the Medicare Access & CHIP Act (MACRA).
Worked with leading research institutions, major industry associations, key House and Senate leaders, and the administration to secure a positive CMS coverage determination for bone-anchored hearing devices.
Secured a $1B provision in the 2020 omnibus spending bill to delay a significant requirement for hospitals and health systems participating in Medicare value based care programs.
Obtained the first-ever Medicare reimbursement, CPT Category 1 code, and NAQA/HEDIS/MIPS quality measure for an autonomous AI system.
Lobbied Congress on behalf of Insulet to get CMS approval for an insulin delivery product.
Succeeded in working with a national health professional organization to secure over US$10m in direct funding for specific health professional training and loan guarantees.
Worked with several corporations and industry associations to secure critical appropriations report language supporting access and reimbursement for specific medical technologies.
Lead agency counsel for implementation of Affordable Care Act, including provisions governing health insurance coverage and Medicare Advantage plans.
Advised a drug company on strategies for obtaining orphan drug approval and worked with scientific and regulatory groups to draft and submit designation request.
Advised a U.S. medical device company on regulatory and commercial issues regarding the market launch of a gene test in 24 European countries.
Instrumental in persuading the FDA to change longstanding regulatory position on awarding exclusivity to fixed-dose combination products, benefitting Gilead's products in the HIV and Hepatitis C fields.
Represented pharmaceutical and biologics companies in connection with numerous federal and state investigations of sales and marketing, pricing, Medicaid rebate, FDCA promotional issues, and cGMP compliance.
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