Federal Business Capture Strategies
Securing Medicare Part B Approval for A Small Business’ Product
Simon&Co. successfully advocated for reconsideration of a negative national Medicare coverage decision for a client’s product following two prior denials. Using new studies, cost analysis, and patient testimonials, Simon&Co. engaged key members of Congress, stakeholders, and patient advocates (including veterans and minority organizations in support of reconsideration). The Centers for Medicare and Medicaid Services agreed to the reconsideration, given new clinical efficacy data, and issued a positive coverage decision with evidence development. This decision allows the client to market the product to Medicare beneficiaries while developing more clinical data to bolster the evidence of positive outcomes.
Achieving an FDA Solution for a Biotech Startup
Simon&Co. supported a biotechnology start-up company’s successful effort to negotiate an agreement allowing the client’s product to remain on the market after an unprecedented and unexpected Food and Drug Administration (FDA) product reclassification. While the product was initially regulated as a tissue–with no adverse events or safety signals reported–the FDA decreed that the product must be reclassified as a biologic, approval of which entails a multi-year review. For a small start-up, this was a devastating prospect, destroying jobs and removing a product in use in the field by the Department of Defense in Afghanistan. Working with Congress, Federal agencies, patient advocates, and other stakeholders, Simon&Co. convinced the FDA decision makers that the product must be allowed to remain on the market while the company conducted clinical trials.