Services

Government Relations

Assuring Adequate Veterans Health Funding
Simon&Co. worked with veterans’ services organizations under the leadership of the Disabled American Veterans to propose an alternative funding mechanism for veterans’ health. Simon&Co. recommended changing the Department of Veterans Affairs healthcare budget to an advance appropriation, providing veterans health funding for two years and allowing timely health
systems planning. This approach was adopted into law by the passage of the Veterans’ Health Care Budget Reform and Transparency Act in 2009, as President Obama called it, “the most significant legislative victory for veterans in a generation.”

Simon&Co. successfully lobbied the Maryland delegation to obtain Congressionally Directed Funding (aka an appropriations earmark) to help launch their MDBioHub initiative to expand the workforce in life sciences, biotechnology, and quantum te chnologies with a focus on underrepresented and underestimated populations within the state.

Simon&Co. successfully obtained appropriations report language to block implementation of onerous regulations to eliminate Medicaid NEMT.

Advocacy Research

Simon&Co. drafted a report for Health Outreach Partnership analyzing existing and proposing new health and transportation policies that support increased health access for underserved populations. The report included recommendations for how health and transportation policies can support replication of the successful models including potential new policies to support the creation and sustainability of successful transportation models. Simon&Co. developed an action plan for the policy campaign to promote implementation of the recommendations.

Simon&Co and GWUMC-SPHHP conducted a thorough review and comparison of published recommendations and quality measures for adult immunizations for the Biotechnology Innovation Organization.  The final product detailed existing and proposed measures and recommendations, historical development of measures, revisions, and measures withdrawn from use. BIO used this information to advocate for adoption or changes in vaccine quality measures. 

Business Development

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.