From Benchtop to Kitchen Tabletop, Helping Medicare Beneficiaries Access Laboratory Diagnostics

Integrating processes of NIH, FDA and CMS to reduce wait time between Agency decision points for Medicare beneficiaries' laboratory diagnostics.

Executive Summary

Barriers of turning biomedical science knowledge to translational tools creates a delay in the time for patient populations, particularly Medicare beneficiaries, to access the best treatment options available, and can cost innovators time that they may otherwise devote to refining the quality of their test or treatment. Slack in the product life cycle can happen at many points, but most pronounced are those periods of waiting while trying to identify the correct decision makers and understand next steps. Just as researchers translate scientific discovery into clinical treatment, we will integrate processes of NIH, FDA and CMS to reduce wait time between Agency decision points. Our new front door for innovators will better coordinate procedures and make available Agency expertise at key transitional nodes.

Team Members

Katherine B. Szarama (Team Lead), CMS / CCSQ / Coverage & Analysis Group
Eunice Lee, FDA
Brandi Kattman, NIH

Milestones

August 2017: Project selected into the HHS Ignite Accelerator
September 2017: Time in Accelerator Began
December 2017: Time in Accelerator Ended