Market Access, Pricing, and Reimbursement

Covington advises leading life science and technology companies on navigating strategic legal, regulatory, and policy issues around market access, pricing, and reimbursement in light of rapidly evolving healthcare dynamics and government enforcement priorities. We routinely help our clients engage with key healthcare leaders within HHS, CMS, FDA, DOJ, DOD, VA, and related entities, as well as other policymakers at the federal and state level. Our holistic approach to helping clients navigate these issues includes supporting the commercialization of a range of medical products, including specialty drugs, cell therapies, digital therapeutics, medical devices, diagnostics, and related digital platforms.

Covington’s expertise and experience specializes on matters related to drug pricing and reimbursement, the Inflation Reduction Act, fraud and abuse laws, healthcare compliance and investigations, public policy and advocacy, government pricing, government procurement, and market access.

Representative Matters

Regulatory Strategy and Compliance

• Advise life sciences clients on drug pricing provisions of the Inflation Reduction Act.
• Advise life sciences clients on regulatory strategy for clinical stage development and regulatory approval.
• Analyze state and federal regulatory compliance issues with respect to manufacturing, distribution, and other requirements.
• Provide strategic regulatory advice in False Claims Act cases and other litigation.
• Analyze state and federal regulatory compliance obligations related to contracting, pricing, manufacturing, distribution, prescribing, and dispensing medical products.

Government Investigations and Litigation

• Represent healthcare 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 the 340B Drug Pricing Program.
• Represent life sciences clients in significant contract disputes with major PBMs on rebate liability and related issues.

Market Access Contracting and Legal Strategies

• Assist life sciences clients in preparing for negotiations with CMS under the Inflation Reduction Act.
• Develop value-based contracts, outcomes measures, technology platforms, and clinical services for biopharma clients across several therapeutic areas.
• Conduct independent analysis for biopharma pricing committee to inform product launch pricing and PBM rebate strategies.
• Negotiate terms and resolve significant contract disputes with PBMs and other supply chain entities for rebates, discounts, and service arrangements.
• Design specialty pharmacy distribution network contracts, as well as patient hub service programs for several orphan products.
• Represent clients regarding compliance with the requirements of the 340B Drug Pricing Program as well as audits, disputes, and litigation regarding program requirements.
• Advise life science clients on use of RWE and HEOR-related communications to payers, providers, and formulary decision-makers.
• Support pricing, contracting, distribution and market access strategy for specialty product launches in oncology, immunology, neurology, and rare diseases
• Develop pricing, contracting, and payer messaging strategies for life sciences clients to address biosimilar market entry.
• Conduct assessment of digital health and e-prescribing impact to market access contracting and provider messaging for life sciences clients.
• Assess market opportunities across payer types, settings of care, and disease states, including potential of integrated bundled drug and diagnostic test offering.
• Lead strategic reviews of global Health Technology Assessment (HTA) engagement preparedness and tactical plans for newly launched products.

Coding, Coverage, and Reimbursement

• Assist a life sciences client in obtaining Medicare Part D coverage for its previously excluded product.
• Advise on coding, coverage, and reimbursement approaches for a Bluetooth-enabled drug dispensing device and related technologies.
• Assist a medical device client in its efforts to secure Medicare pass-through coverage of its innovative diagnostic device.

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, 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.

Advocacy and Policy

• Engage with CMS and FDA on market access pricing and reimbursement-related issues.
• Prepare public comments and various submissions to CMS, FDA, and other related agencies regarding rulemaking and agency information requests.
• Advise clients on public policy developments and compliance implications for new legislation or regulations, particularly with respect to recent drug pricing initiatives.
• Assist with state advocacy related to state-based health insurers and the Medicaid program.

Regulatory Due Diligence

• Conduct regulatory due diligence for mergers, acquisitions, and public offerings.