Covington & Burling LLP operates as a limited liability partnership worldwide, with the practice in England and Wales conducted by an affiliated
limited liability multinational partnership, Covington & Burling LLP, which is formed under the laws of the State of Delaware in the United States
and authorized and regulated by the Solicitors Regulation Authority with registration number 77071..
An unrivaled practice for strategic, cross-cutting advice in navigating U.S. and global health care and market access dynamics.
Covington advises leading life sciences and technology companies on the legal, regulatory, and policy issues that drive market access in an increasingly complex health care environment. We help clients navigate evolving pricing dynamics, reimbursement requirements, compliance risks, and government enforcement priorities, including engagement with the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Food and Drug Administration (FDA), the Department of Justice (DOJ), the Department of Defense (DOD), the Department of Veteran Affairs (VA), and other policymakers at the federal and state level. Our holistic approach to navigating these issues help to support clients in the commercialization of innovative products, including specialty drugs, cell therapies, digital therapeutics, medical devices, diagnostics, and health technology platforms.
We leverage considerable expertise from senior advisors in our U.S. and global practices, including practitioners with extensive industry expertise and direct experience in HHS and CMS health care programs. Covington’s expertise includes:
Drug pricing and reimbursement
Most-Favored-Nation policies and engagement
Inflation Reduction Act implementation
Government price reporting
Fraud and abuse laws
Health care compliance and investigations
Government procurement
Channel and rebate contracting
State law monitoring and compliance
Public policy and advocacy
Our team regularly advises on Medicare Parts B and D, the Medicaid Drug Rebate Program (MDRP), the 340B Drug Pricing Program (340B), state drug pricing laws and Prescription Drug Affordability Boards (PDABs), and other regulatory programs affecting life sciences companies. We also advise on market dynamics, including pharmacy benefit manager (PBM) contracting and related issues, that affect life science company engagement in the supply chain.
In addition, Covington draws on our other leading health care capabilities to provide holistic advice to clients on novel market access arrangements, including fraud and abuse, health privacy, medical product advertising and promotion, and practice of medicine considerations. Our representation of clients across the life sciences spectrum provides unique insights into industry practice and allows us to help clients align risk with their business imperatives.
Recognized as the 2025 Life Sciences Group of the Year and the 2025 Compliance Group of the Year by Law360, our lawyers collaborate seamlessly across practices, industries, and jurisdictions to develop creative and practical solutions. With hundreds of lawyers actively practicing in multiple disciplines and geographies, our group offers one of the largest and most comprehensive industry-focused practices in the world.
Please see more for additional details on our Industry Experience and Cross-Functional Experience.
Regulatory Strategy
Advise clients on product-specific regulatory and commercialization strategies for clinical stage development, regulatory approval, and market launch.
Advise clients on implementation and compliance with the drug pricing provisions of the Inflation Reduction Act, including the Medicare Drug Price Negotiation Program, Inflation Rebates Program, and Manufacturer Discount Program.
Support clients in preparing for and conducting negotiations with CMS under the Inflation Reduction Act.
Advise clients on Most-Favored-Nations initiatives, including government engagement, impact assessment, legal challenges, and business and regulatory strategies.
Assist life sciences clients in preparing applications for the GENEROUS Model in Medicaid and complying with novel price reporting obligations.
Government Price Reporting
Advise life sciences clients on compliance with the Medicaid Drug Rebate Program (MDRP), including issues related to the effect of pricing strategies regarding Average Manufacturer Price, Best Price, Average Sales Price, and other related price reporting calculations.
Advise clients on compliance with the Medicaid Drug Rebate Program (MDRP), including issues related to the effect of pricing strategies regarding Average Manufacturer Price, Best Price, and other related price reporting calculations.
Assist life sciences clients in conducting internal audits of their price reporting functions and determine the necessity for submitting restated price reports.
Advise life sciences clients regarding compliance with the requirements of the Veterans Health Care Act (VHCA) and VA Master Agreement, including non-Federal Average Manufacturer Price calculation and reporting, calculation of Federal Ceiling Price, and negotiation of pricing for sales on the Federal Supply Schedules (FSS) administered by the VA, as well as other questions arising in the performance of contracts for sales to U.S. Government Agencies.
Counsel life sciences clients regarding compliance obligations and price calculations under the TRICARE and 340B Drug Pricing Program.
Assist life sciences clients in investigations and assess potential violations under the pricing - including required price reductions - and other terms of the VA FSS, Master Agreement, and Pharmaceutical Pricing Agreement with the VA.
Legal and Contracting Market Access Strategies
Assess market opportunities across payer types, purchasing channels, settings of care, and disease states, including pricing, rebating, bundling, and related contracting considerations.
Develop value-based contracts, outcomes measures, technology platforms, and clinical services for biopharma clients across several therapeutic areas.
Conduct independent analyses for biopharma pricing committees to inform product launch pricing and PBM rebate strategies.
Advise on direct-to-consumer sales and distribution models, including via telehealth, non-dispensing pharmacies, and TrumpRx.
Negotiate terms and resolve significant contract disputes with PBMs and other supply chain entities for rebates, discounts, and service arrangements.
Advise life science clients on use of RWE and HEOR-related communications to payers, providers, and formulary decision-makers.
Advise clients on structuring patient assistance programs, assessing bona fide service fees and fair market value compliance, meeting physician payment law requirements (i.e., Sunshine Act), and addressing related fraud and abuse risk.
Lead strategic reviews of global Health Technology Assessment (HTA) engagement preparedness and tactical plans for newly launched products.
Coding, Coverage, and Reimbursement
Advise life sciences companies on the intersection of regulatory strategies with coding, coverage, and reimbursement dynamics, including with respect to both retail prescription and buy-and-bill drugs.
Assist life sciences clients in obtaining Medicare Part D coverage for previously excluded products.
Advise on coding, coverage, and reimbursement approaches for Bluetooth-enabled drug dispensing devices and related technologies.
Assist medical device clients in efforts to secure Medicare pass-through coverage of innovative diagnostic devices.
Government Investigations and Litigation
Analyze federal and state regulatory compliance obligations and risk mitigation strategies across contracting, pricing, manufacturing, distribution, prescribing, and dispensing activities.
Represent health care clients in federal and state investigations and False Claims Act litigation concerning sales and marketing practices, government price reporting, FDA post-marketing reporting, PBM and supply chain contracts, and other reimbursement-related issues.
Represent clients in legal challenges regarding government programs, including the Inflation Reduction Act and the 340B Drug Pricing Program.
Represent life sciences clients in significant contract disputes with major PBMs on rebate liability and related issues.
Advise on legal challenge considerations related to government programs and statutory authority, including with respect to Centers for Medicare and Medicaid Innovation Models and Section 402 Demonstrations.
Advocacy and Policy
Engage with CMS and FDA on market access pricing and reimbursement-related issues.
Obtain favorable OIG advisory opinions for life sciences client regarding novel financial arrangements that implicate the Anti-Kickback Statute.
Prepare public comments and various submissions to CMS, FDA, and other related agencies regarding rulemaking and agency information requests, including GLOBE and GUARD proposed rules on Most-Favored-Nation mandates in Medicare and IRA guidance and rulemaking efforts.
Advise clients on public policy developments and business implications for new legislation or regulations, particularly with respect to recent drug pricing initiatives.
Monitor state law developments and assist with state advocacy related to state-based health insurers and the Medicaid program.
Business Development and Regulatory Due Diligence
Support design and implementation of key market access terms in commercial agreements, including milestones and royalty step-downs based on Inflation Reduction Act, Most-Favored-Nation, and related developments.
Conduct regulatory due diligence for mergers, acquisitions, and public offerings.
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