Life Sciences – Regulatory and Reimbursement

Holland & Knight's Healthcare & Life Sciences Team includes a number of lawyers and professionals who are well-versed in the niche practice of serving the full regulatory, compliance and reimbursement needs of life sciences companies.

Our team's extensive experience includes the development and execution of integrated strategies that leverage our attorneys' and professionals' substantial regulatory knowledge. This enables life sciences companies to develop, manufacture, market and distribute medical devices, prescription drugs, biologics, combination products, biosimilars, over-the-counter (OTC) drugs, dietary supplements and other products regulated by the U.S. Food and Drug Administration (FDA) with the assurance that they are complying with federal regulations as well as applicable state laws.

In addition, our deep knowledge of the reimbursement process helps companies navigate Medicare, Medicaid and private insurance rules and systems to maximize reimbursement for their products.

Life Sciences Regulatory Advice

Holland & Knight literally "wrote the book" on these issues as it authored the Bloomberg BNA portfolio Life Sciences Compliance: A Pre-Market and Post-Market Road Map. Some of our team's sample representations include:

• performing "regulatory due diligence" for investors in biotechnology and medical device companies
• advising companies on pre-market and post-market regulatory strategies, including product classification
• representing companies in meetings with FDA officials
• negotiating terms of clinical trial agreements with research institutions and investigators
• helping companies assess and navigate the regulatory pathway to market for novel technologies
• advising companies on FDA marketing rules and labeling claims
• advising companies on compliance with FDA regulations
• counseling and representing companies before the FDA on voluntary recalls
• counseling clients during inspections and post-inspection matters, responses to FDA Form 483s, untitled and warning letters, and other enforcement actions
• representing client interests during FDA and other agency rulemaking proceedings
• advocating client interests before state and federal lawmakers and legislators, including the formation of coalitions to advance client healthcare priorities

Reimbursement: Coverage, Coding and Payment

Holland & Knight attorneys and professionals have broad and deep knowledge of Medicare, Medicaid and private insurance reimbursement issues. Our representations include:

• working with the Centers for Medicare & Medicaid Services (CMS) and its Medicare Administrative Contractors to modify or develop either local or national coverage policies
• intervening with the CMS on regulatory implementation issues
• translating complex legal and regulatory issues involving value-based payment models into a practical, real-world framework and developing necessary strategies performing reimbursement analysis
• helping companies navigate public and private payment systems to maximize reimbursement
• helping clients respond to proposed payment rules through comment letter development and submission
• applying for appropriate product codes to facilitate tracking and future payment of FDA-regulated products
• performing "reimbursement due diligence" for investors
• analysis and strategies for reimbursement under Medicare and Medicaid
• obtaining reimbursement for new technologies
• analysis of value-based pricing strategies and models
• advocating client interests before state and federal lawmakers and legislators, including the formation of coalitions to advance client healthcare priorities
• analysis of hospital outpatient, inpatient and physician payment systems, including obtaining reimbursement changes to support products

Our lawyers also provide a wide range of additional legal support for life sciences companies and investors, including counsel on issues involving supply chain, intellectual property, immigration, mergers and acquisitions (M&A), taxation, securities and other corporate matters.