Bundled payments pay a single, episode-level price covering all services (hospital, physician, post-acute) for a defined clinical event such as a total joint replacement. CMS BPCI Advanced and CJR are examples. Bundles usually cover a period such as 90 days after discharge and compare spending to a target price, with the provider sharing savings or losses. CJR, which ran from 2016 through 2024, and BPCI Advanced are major CMS examples, and CMS's TEAM model starts in 2026. Hospitals in bundles push for lower device prices and products that reduce complications.

Why it matters

Bundles pressure device prices and post-acute spend. Devices that reduce complications, enable same-day discharge, or shorten rehab are commercially advantaged.

Common pitfalls

•Misconception: Bundled payment models directly regulate medical device pricing, they do not, rather they influence purchasing decisions.
•Assuming that because a device is included in a bundled payment, it is automatically compliant with regulatory requirements, overlooking necessary pre-market approvals or post-market surveillance.
•Failing to consider the impact of bundled payments on post-market surveillance data, as adverse events may be attributed to the overall episode of care rather than specific devices.
•Neglecting to assess how device modifications or new device introductions might affect the cost structure and outcomes within established bundled payment programs.
•Ignoring the need for robust real-world evidence collection to demonstrate device value and cost-effectiveness within a bundled payment framework.

Sources

CMS BPCI Advanced · CMS Innovation
Transforming Episode Accountability Model (TEAM) · CMS

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Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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