“Valley of Death” for Medical Innovation: Overcoming Barriers to Reimbursement
950 AI/ML algorithms are approved by FDA until Aug 2024 (https://buff.ly/3lTP5I5). Innovative medical technologies have the potential to transform patient care, offering breakthrough solutions for complex conditions. Yet, many of these groundbreaking devices face a significant barrier that prevents them from reaching the patients who need them most — lack of reimbursement. Less than 10 of these algorithms have reimbursement.
Known as the "valley of death," this gap occurs after FDA approval but before insurers, including Medicare, make coverage decisions. During this time, many life-saving technologies remain out of reach for patients, as healthcare providers struggle with uncertainties around reimbursement.
CMS’s recent Transitional Coverage for Emerging Technologies (TCET) program (https://buff.ly/3yyBdgN) is a step in the right direction, but the road to widespread adoption remains challenging. The limited scope of the program, resource constraints, and the exclusion of diagnostics mean many devices are still left in limbo.
To truly drive innovation in healthcare, we need policies that bridge the gap between FDA approval and coverage decisions, ensuring that cutting-edge technologies can be rapidly adopted to improve patient outcomes. Stakeholders in healthcare, industry, and government must come together to advocate for streamlined reimbursement processes and adequate resources for regulatory bodies.
#healthcareinnovation #medicaldevices #aiecosystem
Senior Director of Content and Experience at Momentum Events
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