The health and biosciences sector is critical to the overall health and vitality of our nation. Diverse, highly complex and oft-changing, the sector frequently finds itself at the center of today's greatest policy debates. The sector's intersection with the federal government — through its funding, regulatory and oversight arms — is deeply engrained.
The FaegreBD Consulting health and biosciences practice team delivers advisory and advocacy services to entities across the health and life sciences sector, supporting work that moves from the development of hypothesis-driven basic research discoveries within academic institutions; through research translation (often in close partnership with venture philanthropic patient groups), clinical development, commercialization, regulation and reimbursement; and into health system delivery and ultimate population health. Thus, our clients include:
- Academic research institutions
- Pharmaceutical manufacturers
- Biotechnology, vaccine and medical device manufacturers
- Venture capital and venture philanthropic organizations
- Health care providers and provider systems
- Payers
- Trade associations
- Patient advocacy organizations
In addition to understanding from where we have come, we have a keen grasp of the sizeable changes looming ahead and counsel clients with an eye on the future, not the past. FaegreBD Consulting seamlessly integrates specialized political support with expertise in regulatory and reimbursement consulting to create opportunities within government sectors and avert potential government-imposed problems. Our technical and scientific consultants steer a product through complex government regulatory hurdles and payer review. Our government affairs consultants navigate Congress and federal agencies to advance client missions and objectives, often establishing new collaborations with federal agencies that are supported by a blend of public and private funding streams.
Our expertise and services span all areas necessary to achieve successes in public policy and advocacy today. This includes deep substantive and technical experience on the issues involved in our work; the ability to write and communicate effectively; proven coalition leadership and management capabilities; established credibility with Congress, the administration and federal agencies; and political, public affairs and campaign skills — all brought to bear as needed to achieve results.
Core functions of our work are described below:
Government Affairs
We craft evidence-driven solutions across the federal landscape. With Congress, we evaluate, amend and design legislative opportunities to advance our clients' priorities. This proactive approach draws on our in-depth knowledge of congressional committees' areas of emphasis, prior legislation that is due for reauthorization and external forces that may stimulate legislative activity. The firm has significant experience drafting legislation, obtaining budget scoring and producing in-depth analysis of emerging bills. We resolve tensions between the adoption of new medical technologies and health care budgets; create innovative partnerships between federal agencies and academic research institutions, industry and nonprofit entities; develop and manage national coalitions; craft amendments for funding assistance; and secure regulatory relief.
As is required in the federal environment, we track and monitor congressional activity on complex, highly-debated pieces of legislation. We monitor the Federal Register daily on alert for notices from relevant agencies that may solicit public comment on a request for information, a draft, a final rule or guidance on federal regulations and law. And we track grant opportunities in areas of client interest across multiple health agencies.
Government Relations, Advocacy and Coalition Management
As explored more fully below, FaegreBD Consulting is well-known for its strategic coalition development to bring aligned voices from multiple sectors together to effect policy change. The firm has a long history of working closely with leading industry companies and member organizations, academic research organizations, and patient advocacy groups, as part of our approach to forging public policy change. We have consistently and effectively leveraged our credible and long-established relationships across these sectors to bring power and focus to a specific policy goal. This work distinguishes our firm.
Public Affairs
We identify and recruit advocates, determining key audiences, crafting and tailoring messages, and leveraging the news and social media.
Reimbursement and Regulatory Strategy
We deliver comprehensive reimbursement consultation with the ability to draw upon product evidence, communicate beneficiary value, and respond to shifting agency trends. We blend highly strategic advice with concrete reimbursement and regulatory tactics and support. Our discrete reimbursement services are designed to achieve reimbursement-related objectives, including product launches and coverage for critical new services, with associated coverage and coding support.
Federal and Federally Related Funding
We have a proven track record in delivering strategic counsel, proposal strategies and project management support on responses by for-profit and nonprofit clients to high impact federal funding opportunities. Our experience includes:
- Proposals by academic research institutions for large National Institutes of Health (NIH) comprehensive center grants in translational science, cancer and other focused areas
- Responses for major funding opportunities such as vaccine development through the Biomedical Advanced Research and Development Authority (BARDA)
- Innovation support in health care delivery issued through the Centers for Medicare and Medicaid Services (CMS) and its Center for Medicare & Medicaid Innovation (CMMI)
- Proposals to participate in the new Patient-Powered Research Networks (PPRNs) structured through the Patient-Centered Outcomes Research Institute (PCORI)
Across all areas of our work, we have a proven track record of exceeding client expectations. In short, we understand the need to position a client's strengths in response to where the federal market is searching for value. We are an inventive partner, and we know how to get the job done.