James Coffelt

James Coffelt supports clients in market access, product commercialization, and reimbursement strategy.

With experience in healthcare finance, clinical medicine, and strategy consulting, he provides unique insight from the provider and payer perspectives to enable clients to broaden patient access and to better understand the implications of public policy.

Prior to joining Avalere, James was a strategic business consultant with BowTie Medical where he helped spearhead the expansion of a new health sharing initiative and solidified business growth strategies for clients. As a consulting intern with Dixon Hughes Goodman, LLP, he worked on multiple projects that developed new ambulatory surgery centers for growing health systems and contributed finalized strategy diagnostic models for healthcare clients to summarize and predict revenue streams.

James has an MBA and an MS in medical physiology and biophysics from Case Western Reserve University and a BA in political science and kinesiology from Rice University.

Authored Content

Manufacturers seeking Food & Drug Administration (FDA) approval for cell therapies will need to assess the financial and logistical burden on patients and develop novel solutions to help alleviate these challenges.

Implementation of copay accumulator and maximizer programs continues to increase; recent policy provisions finalized through federal rulemaking and state-level legislation have created new uncertainty for the future of these programs and the stakeholders they affect.

With a number of cell and gene therapies (CGTs) expected to obtain Food & Drug Administration (FDA) approval in the next 3 years, stakeholders must consider the unique patient access and affordability barriers that may limit patient ability to receive these novel treatments. Stakeholders should explore affordability solutions that can optimize access, or they risk excluding patients from obtaining potentially life-saving treatments.

Recent CMS rulemaking has expanded the opportunity for new drugs and devices to achieve NTAP status, either through the traditional process or via alternative. Manufacturers that are nearing the launch of new technologies, especially in the antimicrobial space, should assess whether their technology may qualify for NTAP. Applications for NTAPs effective in FY 2022 are due this fall.

Although COVID-19 is introducing new challenges within the global pharmaceutical supply chain, the current situation also creates opportunities for stakeholders to evaluate drug security and implement risk-mitigation strategies around shortages and required stockpiles.

Additional Medicare payment options available for new, high-cost technologies used in the inpatient setting.