Expansion of the United States Medicare bundled payments programme to include cardiovascular and hip fracture services marks another step in the global march toward health insurers placing hospitals, doctors and other providers at financial risk for the cost and quality of the care they deliver. This shift to value-based payment has profound implications for medical device developers and manufacturers.
Each of these developments presents both challenges and opportunities. Generally speaking, they will push device sponsors to collaborate more closely with providers and payers. Providers will need support, standardizing procedures and to demonstrate improved outcomes. Payers will need evidence of the clinical value and cost-effectiveness of all devices, in particular those that disrupt or depart from current practice standards.
Addressing these needs will require device sponsors and developers to generate compelling evidence not only of clinical safety and efficacy of their products, but also of their positive effects on community health and overall healthcare costs. This will mean paying more attention and devoting additional resources to health economics and outcomes research.
In this white paper, we outline several specific challenges value-based care will present, along with success strategies for transforming them into opportunities for innovation and increased market share.