Unlock Access to Wearable Devices Through New CMS and FDA Programs
Learn how innovative programs will speed up device integration. According to the Centers for Disease Control and Prevention (CDC), three of four adults in the United States have at least one chronic condition. Managing conditions like diabetes and hypertension requires consistent monitoring and early intervention, yet many patients face barriers to frequent in-person visits. Medical wearables provide the continuous, objective data needed to bridge this gap, but they have historically been stalled by regulatory delays and payment barriers. Encounter Development Roadblocks Three roadblocks have long limited wearable device integration. First, it takes an average of three to seven years for a device to have Food and Drug Administration (FDA) approval and reach market. Technology moves quickly and devices risk becoming obsolete during these years. Second, Medicare offered little incentive to cover novel wearables, making it difficult for providers to justify the time investment in reviewing device data. Third, remote physiologic monitoring CPT® codes required at least 16 days of monitoring and at least 20 minutes of real-time interactive patient-provider communication monthly, making implementation impractical for many. Between December 2025 and January 2026, solutions to all three roadblocks emerged. The Centers for Medicare & Medicaid Services (CMS) announced a new value-based payment model, Advancing Chronic Care with Effective, Scalable Solutions (ACCESS), launching July 5. To support ACCESS, the FDA created the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot to fast track innovative devices to ACCESS participants. In addition, the AMA released updated CPT® codes effective Jan. 1, 2026, that make wearable monitoring more practical. This regulatory alignment enables a faster wearable integration into chronic care. Get to Know the ACCESS Payment Model ACCESS is a new value-based payment model that tests outcome-aligned payments (OAPs), which are recurring payments for managing certain chronic conditions. The model launches July 5 and will run for 10 years. Organizations or suppliers enrolled in Medicare Part B may apply to participate. ACCESS participants receive payments for patients who show improvement or control in one of the four targeted clinical areas: The model creates financial incentives for providers to use monitoring technologies that improve patient outcomes. When a patient achieves target blood pressure levels, reduces chronic pain, or improves anxiety symptoms, providers benefit through the OAPs. However, many innovative wearable devices that could help achieve these outcomes lack FDA authorization, creating a barrier to implementation. Engage the TEMPO Pilot To address the regulatory bottleneck, the FDA announced the TEMPO pilot program in December 2025. TEMPO creates a pathway for certain digital health devices to reach ACCESS participants faster while maintaining safety oversight. The FDA expects to select up to 40 U.S.-based manufacturers for the program, with about 10 in each of the four clinical use areas. TEMPO allows these manufacturers to offer their products to ACCESS participants under the FDA’s Enforcement Discretion Policy while collecting real-world data. This bypasses requirements that slow the timeline, such as premarket authorization. Manufacturers must demonstrate their device is not a serious health risk and provide a timeline for their formal marketing submission, such as premarket notification 510(k), after collecting real-world evidence during the pilot. TEMPO devices must align with one of four ACCESS clinical areas targeting chronic conditions. Devices may be “off-the-shelf” wearable products. TEMPO-eligible devices will be paired with clinician-supervised care. Organizations must also assign a physician clinical director to oversee safety. Example: A continuous glucose monitor (CGM) for diabetes management would require a physician to review glucose patterns and adjust dietary counseling or medication as needed. A wrist-worn alcohol biosensor for patients with alcohol use disorder might involve clinician review of drinking patterns with substance-use counseling. ACCESS participants must obtain patient consent before using TEMPO devices, informing them the FDA will receive safety and performance data. TEMPO participation is optional but provides access to innovative devices. TEMPO targets devices that provide monitoring for the following four ACCESS clinical areas: ACCESS Track Example Condition Example Wearable Devices Outcome Aligned Payment (OAP) Measure Example Early Cardio-Kidney-Metabolic (eCKM) Hypertension Continuous blood pressure monitors, physical activity trackers Control or improve blood pressure Cardio-Kidney-Metabolic (CKM) Diabetes with chronic kidney disease CGM Control or improve lipids Musculoskeletal (MSK) Chronic musculoskeletal pain Physical activity trackers, sleep trackers Improvement in pain intensity level and function Behavioral Health (BH) Anxiety Electrocardiogram (ECG), sleep trackers Improvement of Generalized Anxiety Disorder-7 (GAD-7) anxiety score symptoms Recognize New 2026 Remote Physiologic Monitoring CPT® Codes Effective Jan. 1, 2026, the AMA introduced two new CPT® codes that make wearable device monitoring more practical and billable: These new codes support TEMPO and ACCESS implementation. Code 99445 covers device supply with daily recordings or programmed alerts for two to 15 days in a 30-day period, down from the previous 16-day minimum. This allows clinicians to monitor patients in shorter intervals based on clinical need rather than meeting a 16-day minimum. Code 99470 captures 10-19 minutes of real-time interactive communication by clinical staff, a physician, or other qualified healthcare professional for remote physiologic monitoring treatment management, down from the previous 20-minute requirement. Code 99457 (… first 20 minutes) remains valid for sessions of 20-39 minutes. These updates reflect that wearable devices can provide meaningful insights in shorter timeframes. A physician can now bill for reviewing seven days of continuous blood pressure data and spending 15 minutes discussing findings with a patient, which was previously under the minimum. Note: According to CPT® guidelines, the devices covered by these codes must be medical devices as defined by the FDA and must be ordered by a physician or other qualified healthcare professional. What This Means for Healthcare ACCESS and TEMPO represent a major shift in how digital health devices reach patients. Patients gain earlier access to potentially beneficial technologies while manufacturers collect real-world evidence to support formal FDA approval. Wearable devices provide continuous, objective data that supplements traditional care. Instead of relying on patient-reported symptoms or infrequent lab tests, providers can track metrics like physical activity patterns, sleep stages, or blood oxygen between visits. This allows earlier intervention before conditions worsen. TEMPO is initially limited to ACCESS Medicare Part B participants, but the real-world data collected will support future FDA marketing submissions. These devices, if they meet FDA approval, will eventually become available to all patients. Angela Halasey, BS, CPC, CCS, Contributing Writer
Understand TEMPO-Eligible Devices
These devices generate objective data tied to outcome measures. For example, wearable ECG monitors measure heart rate variability (HRV), which helps providers assess treatment for anxiety disorders.
