Strategy that Transforms Future Opportunities

Catalyst Healthcare Consulting helps clients distill complex health care issues into meaningful commercial and philanthropic opportunities. Catalyst helps clients better understand the Washington, DC policy environment and FDA & CMS regulatory dynamics. We create cross-agency and cross-discipline strategies to help clients drive policy formation in the constantly evolving regulatory and payment framework.

We are customer-focused and relentlessly goal-oriented. We structure our projects to achieve specific milestones, as identified in collaboration with clients. We pride ourselves on staying out in front of a client’s issues — anticipating their needs, and creating proactive ideas for advancing corporate, reputational and philanthropic goals.

Examples of our approach:

We help to achieve our clients’ objectives by:

  • Helping to create regulatory and payment pathways for innovative new products and technologies for companies, payors and providers
  • Building strategic plans that drive the always-changing regulatory and reimbursement environments
  • Engaging in policy development:
    • Helping to shape policies as they develop, both in the US and internationally
    • Answering the question: How will FDA regulate this new, novel technology? How will CMS reimburse it? How will state Medicaid programs cover and reimburse it?
  • Identifying new, emerging policy opportunities, and developing multiple options for the client to respond or engage
  • Crafting policies that advance clients’ interests, while supporting the FDA, CMS and state payors’ missions
  • Anticipating and shaping complex health care issues that can affect our clients’ business, and addressing FDA regulatory hurdles and payment hurdles that can arise during the product development and approval process
  • Creating engagement strategies to find win-win-win solutions that benefit the patient, client, payors and regulators
  • Building teams that the client loves and federal and state agencies respect
    • Our strength is not only our internal expertise but the team we can knit together to deliver the right advice to the client
    • We have built a strong network of external expert advisors who come with deep FDA. CMS, State Medicaid, and advocacy expertise
  • Building targeted, strategic networks – e.g., with federal agencies, patient advocates, companies, academics and other thought leaders – to increase leadership influence in Washington
  • Identifying and forging synergistic partnerships with decision makers and thought leaders
  • Developing strategies for advisory committee meetings
  • Providing strategic advice on Breakthrough Therapy Designations requests
  • Gathering Regulatory Intelligence to foster a better understanding of FDA, HHS & CMS
  • Highlighting trends that could impact a client’s portfolio or corporate strategy
  • Tracking key issues to keep clients up to speed on opportunities and challenges

We bring a 360-degree perspective to our clients’ needs, based on our leadership and staff experience in all sectors of health care:

  • FDA
  • CMS
  • HHS
  • Industry
  • Trade associations
  • Health insurance
  • Investment houses
  • Health care journalism
  • Capitol Hill
  • State Medicaid programs
  • Regulatory
  • Policy
  • Politics
  • Commercialization
  • Reimbursement
  • Coverage
  • Ally development