The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs, devices, and data.
As discussed in more detail in our first and second Alerts, on May 13, 2025, CMMI signaled a new direction for value-based care by releasing a white paper titled "CMS Innovation Center Strategy to Make America Healthy Again," a request for information on digital health, and a webinar with Centers for Medicare & Medicaid Services ("CMS") Administrator Dr. Mehmet Oz and CMMI Director Abe Sutton. CMMI plans to turn the last 15 years' learnings into a health system that empowers people to thrive and achieve their own health goals. This plan would ostensibly lay the foundation for new opportunities directed at drugs and devices in the value-based care space and expanded data resources for many health care stakeholders.
Improving data collection and incorporating new approaches to drugs and devices are at the center of CMMI's strategy in value-based care. Greater inclusion of drugs and devices into value-based models, which CMMI Director Sutton suggested may accompany a general shift away from fee-for-service device payments across CMS programs, will provide new flexibility for the drug and device industries. Significant highlights included:
- New Drug and Device Waivers: CMMI plans to develop new waivers that support predictable cost-sharing for certain drugs and devices that improve outcomes and reduce costs. As a specific example, CMMI announced potential new waivers for accountable care entities that assume global risk to provide durable medical equipment that bypass National Coverage Determinations if they support transition to or remaining in the home.
- Broader Drug Reform: CMMI proposed the development of new value-based drug and insurance designs and potential structural reform to drug pricing in conjunction with broader actions taken by the Trump Administration.
- Expanded Data Collection: CMMI plans to build on the experience from past initiatives to drive data transparency, expand its data collection capabilities, and promote such data's use among patients and providers by leveraging new technology to help people drive their individual health goals.
- Implement More Accessible Data Systems: CMS intends to improve patient care more generally by implementing new interoperable systems and encouraging the development of consumer tools that are used across the health systems for both consumer and provider use.
