Overview
Supply chain and regulatory unpredictability. Fierce competition. Evolving markets. To succeed, life sciences companies need to operate with technical ingenuity, smart strategy and clear policy insight.
With our deep bench, including former government officials, former industry C-suite executives, and leading-edge health law attorneys, Manatt is the go-to firm for life science companies. From preclinical startups to global leaders in the pharmaceutical, biotech and medical device industries, Manatt is relied on for data-informed, strategic consulting, policy, legal, and regulatory advice and representation.
- Preparation of written submission for Medicare drug price negotiations, training negotiating teams and advocating before Centers for Medicare & Medicaid Services (CMS) on policy change
- Navigating state Prescription Drug Affordability Board (PDAB) requirements
- Advising on value-based agreements with Medicaid and commercial payers
- Participation in the Center for Medicare and Medicaid Innovation (CMMI) models
- Advising on impacts of international reference pricing
- Real-time summaries and analyses of critical federal and state policy developments, including impact on clients’ business lines
- Strategic policy and advocacy plan creation. Insights on legislative and regulatory pathways to pursue targeted policy strategies and develop ideas for policy and legislative reform
- Drafting legislation, lobbying and advocacy strategies
- Drafting comment letters, applications and other correspondence directed at government agencies
- Regulatory compliance advice
- Market access assessments to determine payer coverage, coding and payment landscape for new or existing products
- Improving government program access and reimbursement for complex, high-priced therapies
- Assessments of coverage by public payers, including legal guidance on how key Medicaid and Medicare laws impact coverage and reimbursement
- Analysis of 340B challenges and opportunities for pharmaceutical companies
- Commercial coverage and reimbursement strategies, including advocacy and advice related to Internal Revenue Service and Employee Retirement Income Security Act rules, as well as guidance on patient support programs and health plan benefit design
- Value-based payment model analysis across multiple payers for targeted therapeutic areas
- Medicare new technology add-on payment applications
- Other coding and coverage applications, including OPPS passthrough, HCPCS coding and Benefit Category Determination applications
- Collaboration with clients to advocate for specific issues and legislative efforts
- Legislative drafting, research and analysis
- Developing and maintaining key relationships with Congress and the Administration (U.S. Department of Health and Human Services, White House, etc.)
- Coordinating meetings with federal health policymakers and lawmakers
- Developing issue papers and policy statements, including the development of testimony and other official statements submitted to the federal government
- Liaising with professional organizations at the advocacy and leadership levels
- Advising on best FDA pathway to market
- Regulatory strategy as a competitive advantage, including first mover and competitive market barriers
- Legislative advocacy and strategy
- Policy development and analysis
- Guidance on complex statutory schemes, including those governing generic drugs, orphan drugs and biosimilars
- U.S. Food and Drug Administration compliance and best practices
- Product labeling and marketing compliance
- Regulatory landscape assessment across innovative product areas, including health tech, gene therapies and combination products
- Go-to-market guidance, including identifying target populations, market sizing and developing performance management goals from the C-suite throughout the organization
- Supporting complex product launches entering the U.S. market or globally, including medical affairs organizational strategy and clinical trials.
- High-impact marketing strategies to launch product
- Establish sales and sales operations goals working directly in the field to offer coaching, accelerating short- and long-term sales
- Handling market access issues, including payer negotiations and obtaining optimal reimbursement terms, including hotlines, appeals and pricing tiers
- Planning, sourcing, manufacturing and distribution/logistics
- Capital management enabling:
- Strategic and annual/long-term financial planning
- Resource allocation and management
- Project management and execution
- Benefit realization, including tracking and monitoring
- Administrative law and constitutional challenges to statutes and government programs
- Government price reporting and related False Claims Act litigation
- Advertising and marketing claims
- Privacy and data security litigation
- Medicare and Medicaid issues
- Compliance and risk assessments
- Examining trends in utilization and costs associated with specific drugs, medical devices and clinical services at the national, state and substate levels
- Comparing outcomes and cost-effectiveness for competitor drug products or devices
- Sizing and assessing characteristics of populations eligible for specific drug products or devices
- Modeling the impact of state and federal regulations on trends in pharmaceutical utilization, costs and outcomes
- Assessing state coverage and reimbursement for pharmaceutical products and medical devices
- Licensed access to nationwide Medicaid and Medicare claims and enrollment data from CMS
- Robust experience with a wide array of datasets, including:
- Medicaid claims data via the T-MSIS Analytic Files
- Medicare claims data, including fee-for-service, Medicare Advantage and Part D data
- Part D Pharmacy and Formulary Network data
- American Community Survey data
- Medical Expenditure Panel Survey data
- Medicare Cost Reports
