FDA selects Dexcom for the TEMPO pilot, bypassing premarket assessment.

      On Tuesday, the US Food and Drug Administration designated Dexcom as the first manufacturer to be included in its Technology-Enabled Meaningful Patient Outcomes pilot program, known as TEMPO. This initiative allows digital health devices to be provided to Medicare patients prior to receiving official approval from the agency for that particular use.

      The mechanism in play is enforcement discretion. Instead of issuing formal approval, the FDA has opted not to enforce premarket authorization requirements for the participating devices, as long as manufacturers collect and share real-world performance data.

      What Dexcom is providing

      The Dexcom Glucose Health Program aims to focus on two clinical use areas within the Centers for Medicare and Medicaid Services ACCESS model. Its goal is to allow patients and their healthcare providers to track metabolic and nutritional status, receive customized guidance, and gain access to real-time data and AI insights that encourage behavioral changes.

      The FDA describes the program as a tool for screening prediabetes and type 2 diabetes using integrated digital health metrics, suggesting it could enhance glycaemic control and reduce HbA1c levels in individuals with prediabetes. The agency indicates it will continue to assess the intended use throughout the pilot.

      “For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-altering,” remarked Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. She emphasized that the selection marks a significant step in generating the “real-world evidence necessary to confirm that these technologies genuinely provide benefits.”

      The underlying payment model

      TEMPO operates in conjunction with ACCESS, a ten-year voluntary payment model from CMS launched this month with over 150 healthcare organizations participating.

      ACCESS introduces what is referred to as outcome-aligned payments, recurring payments linked to whether participating organizations achieve measurable improvements in health rather than simply billing for services provided. It focuses on chronic conditions that affect more than two-thirds of Medicare recipients, including hypertension, diabetes, chronic musculoskeletal pain, and depression.

      “ACCESS offers a transparent payment mechanism that rewards tangible health improvements for patients rather than just individual services, while TEMPO helps generate the necessary real-world evidence to responsibly assess innovative new technologies,” stated Abe Sutton, CMS deputy administrator and director of the Innovation Center.

      A conditional alternative

      Hogan Lovells, a law firm, described the arrangement in December as a CMS-related side door, signifying that the pilot may allow the commercial use and promotion of products that typically would be restricted by device regulations. Their analysis highlighted several unresolved issues regarding the extent of oversight.

      Patients will not be left uninformed, as ACCESS organizations utilizing a TEMPO device are required to obtain enhanced consent from beneficiaries, informing them that the device is part of an FDA pilot and that certain data will be shared with the agency.

      The FDA plans to select approximately ten participants within each of four ACCESS clinical use areas: early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal pain, and behavioral health. It states that its considerations will encompass the potential risks to patient health, safety, or welfare.

      The evidence dilemma

      The pilot operates on the premise that real-world data can partially replace the prospective trials that the FDA has traditionally preferred for device evaluations. Hogan Lovells pointed out that the use of real-world data for supporting device marketing applications has been limited, leading to uncertainty regarding the value of evidence generated through TEMPO.

      The FDA has also warned that participation in TEMPO does not guarantee a favorable outcome regarding any future marketing submissions. The implications for a device, or its users, if the real-world data does not yield conclusive results remain unclear.

      An overarching loosening

      TEMPO is being introduced amid a broader rethinking of the FDA's approach to consumer and AI-driven health technology. Earlier this year, the agency updated two guidance documents, easing oversight on wearables and clinical decision support systems, allowing more AI-powered health products to reach consumers without premarket reviews.

      The commercial landscape is rapidly evolving, outpacing the regulatory framework in place. Amazon launched its Health AI assistant to all US customers this year, joining OpenAI’s ChatGPT Health and Anthropic’s Claude for Healthcare in an effort to provide AI-mediated health guidance to consumers.

      The enterprise healthcare sector is also advancing. Bunkerhill Health secured $55 million to enable hospitals to create and operate their own clinical AI solutions instead of relying on various vendor tools, while Microsoft introduced Copilot Health to scale AI utilization in consumer health inquiries.

      Chronic diseases are the key driver behind this momentum. The WHO predicts that chronic conditions will account for 70% of global deaths by 2030, an increase from 61% in 2005, creating a pressing demand for preventive and continuous monitoring technologies, both commercially and clinically.

      There is currently no deadline for manufacturers to express interest in TEMPO. The FDA has indicated it will continue reaching out to potential participants indefinitely.