Healthcare policy is contentious and continuously evolving. Constant debate rages over such core issues as resource allocation, the respective roles of the public and private sectors, ethical restrictions, and the proper approaches to controlling cost, promoting quality and expanding availability. Health care practitioners and consumers alike face tremendous uncertainty as decisions are made by a confusing array of administrative and legislative bodies.
Whether your matter involves federal funding, legislative policy, Medicare reimbursement, HIPAA compliance or compliance with the Affordable Care Act, Holland & Knight’s Healthcare & Life Sciences Team will combine its legislative know-how with a focused commitment to helping you advance your interests. Our seasoned lawyers – with experience in a wide range of healthcare law, including food and drug law, hospital law, public healthcare law, tax law and Medicare law – understand precisely where, when and how to intervene on your behalf in policy proceedings.
Service to All Sectors of the Industry
We represent stakeholders in numerous areas of the health care industry, including the following:
- state and local governments
- hospital systems
- medical specialty societies
- hospice care providers
- disease management organizations
- clinical laboratories and tissue banks
- medical informatics companies
- pharmaceutical, biotechnology and medical device companies
- tribal councils
We draw from the firm's vast knowledge base to better serve you in your healthcare matters. Your Holland & Knight team may consist of legislative and regulatory attorneys, non-lawyer lobbyists and public relations professionals who bring experience from such areas as the following:
- regulation by the Food and Drug Administration (FDA)
- Affordable Care Act
- fraud and abuse
- health resources
- medical research
- bioterrorism preparedness and response
- medical errors/liability
- preventive health
- veterans' health care
Seasoned Legislative and Regulatory Counsel
Representing your interests through complex legislative and regulatory proceedings requires a thorough understanding of the process itself. The Healthcare & Life Sciences Team includes former members of Congress and other professionals who have served in senior positions in Congress and federal agencies. Experienced in working through legislative channels, our team is committed to helping you be successful by working on your behalf with the appropriate administrative agencies to achieve your objectives.
We also counsel clients on public healthcare policy – including the wide range of administrative and regulatory matters pending before the Centers for Medicare and Medicaid Services (CMS), FDA and other agencies of the Public Health Service.
Hands-On Knowledge of the Appropriations Process
Experience working with key government decision-makers on behalf of our clients – and an intricate understanding of the legislative process – are key to our strategic approach. Our goal is to help you to be successful in securing appropriations from federal sources. As one of the largest federal appropriations practices in the U.S., Holland & Knight is committed to helping clients who seek funding or policy-related assistance through the appropriations process. Federal funding is available for a wide range of initiatives – from construction of healthcare facilities and the purchase of new information systems to the conducting of health services research. We are also dedicated to negotiating with the appropriate sources to help you obtain increases in various Department of Health and Human Services programs.
Practical Experience with Authorizing Legislation
Holland & Knight’s healthcare and life sciences practitioners are committed to helping clients advance their interests through our proactive involvement in bills that will impact the Medicaid and Medicare programs, including reimbursement, coverage and coding; FDA reform and oversight; physician workforce shortage; graduate medical education; disproportionate share hospital payments; medical errors and liability; health information privacy; and health information technology. We are experienced in representing providers, suppliers and other entities before the key committees of jurisdiction in the House and Senate – including the House Ways and Means Committee; the House Energy and Commerce Committee; and the Senate Finance Committee; and the Senate Health, Education, Labor and Pensions Committee.
Insightful Medicare and Medicaid Strategies
Federal and state governments are the largest payors of healthcare services in the U.S. We advise clients on coverage and reimbursement matters before CMS; provide counsel to medical device and biotech clients regarding coordination of their FDA-approval and CMS-reimbursement strategies; and resolve Medicaid-related questions and disallowance disputes. Our team regularly drafts comments on behalf of clients in response to CMS-proposed rules.
Innovative Counsel in Food and Drug Matters
Combining science backgrounds with in-house counsel experience in government and industry, Healthcare & Life Sciences team members offer comprehensive counsel to medical device and biotech companies regulated by the U.S. Food and Drug Administration (FDA).
We provide regulatory guidance to medical device and biotech companies and advise on matters regarding IRB approvals, 510(k) ownership and import issues, requests for expedited PMA reviews, defense of FDA-initiated enforcement actions and inspections, compliance issues, and labeling, relabeling and repackaging requirements.
Our team, which includes intellectual property litigators, prosecutors, patent attorneys and agents with advanced degrees in science and engineering relevant to the healthcare industry and FDA matters, also advises on FDA-related intellectual property matters. We provide counsel to protect innovators' patents and trademarks, including labeling issues and defense against patent infringement claims.
Proactive Compliance Assistance
Providing early guidance and advice on all aspects of compliance with HIPAA policy is part of our strategy for keeping our clients current with evolving regulations. We also advise on compliance with federal fraud and abuse statutes – including the False Claims Act, the Anti-Kickback statute, the Stark Self-Referral Rules and safe harbors. We are committed to leveraging Holland & Knight’s interdisciplinary resources to defend clients facing enforcement actions as well as those who are under investigation by the U.S. Department of Health and Human Services Office of Inspector General or the U.S. Department of Justice.
Federal Grants and Contracts
Are you seeking federal grant funding? Holland & Knight’s Healthcare & Life Sciences Team is dedicated to providing the innovative counsel needed to help our clients secure contractual support from a variety of federal sources – including the Health Resources and Services Administration, Centers for Disease Control and Prevention, National Institutes of Health, TRICARE and CMS. We advise on activities that range from opportunity identification and proposal drafting to bid protests.
Applying Our Knowledge Base
Whether you are a healthcare provider, payor or supplier, Holland & Knight’s Healthcare & Life Sciences Team offers practical experience, a broad base of knowledge and a strong commitment to helping you be successful while navigating through ever-changing health care policy and regulations.