Executive Summary: Converging Regulation and Reimbursement

The traditional paradigm of healthcare innovation—a linear progression from bench to bedside—is fundamentally incompatible with the iterative nature of digital health.  Historically, medical device manufacturers have faced a "chicken-and-egg" dilemma: they require real-world outcomes data to secure regulatory clearance and payer uptake, but they cannot generate that data without the very clearance and reimbursement they seek.  In 2026, the federal government has addressed this structural gridlock through the coordinated launch of the Centers for Medicare & Medicaid Services (CMS) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model and the Food and Drug Administration (FDA) Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot.  By aligning payment incentives with regulatory flexibility, these programs create a synergistic loop that allows digital health tools to enter the clinical workflow sooner, generating the high-trust evidence required for both long-term solvency and market authorization.

CMS ACCESS: The Demand-Side Reimbursement Catalyst

Launching on July 5, 2026, the ACCESS model represents a ten-year national test of an alternative payment methodology designed to replace episodic fee-for-service (FFS) with Outcome-Aligned Payments (OAPs).

Mechanics of Outcome-Aligned Payments

Under ACCESS, Medicare Part B providers receive fixed, recurring payments for the continuous management of beneficiaries with chronic conditions.

• Payment Structure: Participating organizations receive up to 50% of the total OAP in upfront installments to support the operational costs of technology-enabled care.  The remaining 50% is withheld and subject to reconciliation based on clinical performance.
• Performance Metrics: Payments are tied to "Outcome Attainment Rates"—the percentage of a patient panel that meets specific, guideline-informed targets compared to each patient's unique baseline.
• Focus Areas: The model initially targets four high-prevalence clinical tracks: Early Cardio-Kidney-Metabolic (eCKM), Cardio-Kidney-Metabolic (CKM), Musculoskeletal (MSK), and Behavioral Health (BH).

By rewarding clinical results rather than service volume, ACCESS creates a direct financial incentive for providers to adopt digital therapeutics (DTx), remote patient monitoring (RPM), and wearable devices that can drive measurable physiological changes.

FDA TEMPO: The Regulatory Supply Sandbox

Recognizing that digital health devices often improve through rapid iteration in real-life settings, the FDA’s Center for Devices and Radiological Health (CDRH) launched the TEMPO pilot as a voluntary "regulatory sandbox".

Enforcement Discretion and Real-World Evidence

TEMPO allows selected U.S.-based manufacturers of digital health tools to deploy their devices within ACCESS-participating organizations before obtaining full 510(k) or De Novo marketing authorization.

• Regulatory Flexibility: The FDA may exercise "enforcement discretion" for certain premarket and investigational device requirements, provided the device is used under clinician supervision and meets strict safety guardrails.
• Structured Data Collection: In exchange for earlier market entry, manufacturers must commit to sharing real-world data (RWD) with the FDA.  This data is used to generate the Real-World Evidence (RWE) necessary to support future formal marketing submissions.
• Iterative Discussions: The pilot utilizes "sprint" discussions—focused interactions aimed at reaching agreement on endpoints and analysis plans within defined timelines (typically 45 days)—leveraging the framework of the Total Product Life Cycle Advisory Program (TAP).

The Synergistic Loop: Breaking the Innovation Barrier

The true strategic value for healthcare executives lies in the interplay between these two programs.  The alignment of ACCESS and TEMPO eliminates the historical gap between regulatory clearance and reimbursement.

1. Reimbursement Demand: The ACCESS model creates a cohort of providers who are financially motivated to use technologies that reduce biomarkers (like HbA1c or blood pressure) or improve functional outcomes.
2. Regulatory Supply: The TEMPO pilot provides a pathway for manufacturers to supply these clinicians with tools that are not yet cleared but are clinically promising.
3. High-Trust Evidence Generation: Clinicians test clinical hypotheses in the context of "everyday" practice.  The data generated serves a dual purpose: it fulfills the clinical outcome reporting requirements for CMS payment reconciliation and provides the FDA with the real-world performance data needed for authorization.
4. Market Advantage: Companies participating in the synergistic loop gain a multi-year lead over competitors trapped in the traditional, slow RCT-to-reimbursement cycle.

Clinical Tracks and Outcome Targets

The synergy is most potent in clinical areas where technology can bridge the gap between physician visits.

Technical Mechanics: Interoperability and Consent

To ensure the integrity of the synergistic loop, the models mandate high standards for data architecture and patient protection.

• Mandatory Interoperability: ACCESS participants must share standardized clinical updates electronically through FHIR®-based APIs or Health Information Exchanges (HIEs).  This ensures that "ground truth" clinical data flows seamlessly to primary care practitioners (PCPs) and regulators.
• Enhanced Beneficiary Consent: Providers using TEMPO devices must obtain specific consent from patients, informing them that the device is part of an FDA pilot and that their data will be shared with the agency for performance monitoring.
• Co-Management Incentives: To prevent care fragmentation, CMS offers a new co-management payment (approximately $30 per use) to PCPs who review and coordinate care updates from ACCESS participants.

Strategic Implications for Executives

For healthcare leaders, the ACCESS-TEMPO alignment necessitates a shift in organizational strategy:

1. For MedTech Manufacturers: Transition from seeking "clearance first" to seeking "pilot partnership".  The ability to generate RWE while simultaneously earning revenue via ACCESS-participating partners is a significant de-risking event for investors.
2. For Provider Organizations (MSOs): The 50% performance withhold in ACCESS creates a substantial reconciliation risk.  To mitigate this, MSOs must adopt high-fidelity tracking tools that provide real-time visibility into whether a patient is hitting their outcome targets before the reconciliation window closes.
3. For Payers and Self-Insured Employers: These models provide a framework for evaluating digital health tools based on actual "Substitute Spend" reduction (e.g., fewer ER visits or delayed surgeries) rather than theoretical benefit.

Conclusion

The alignment of CMS ACCESS and FDA TEMPO signals the end of "proxy-based" healthcare.  In this new era, market advantage is secured not by those who perform the most procedures, but by those who can provide verifiable, technology-enabled proof of clinical success.  By entering the synergistic loop, healthcare stakeholders can transform clinical encounters into high-trust datasets, driving both patient health and business valuation in the 2026 regulatory environment.

Sources

1. CMS Launches ACCESS Model to Improve Chronic Care - AHCA/NCAL
2. ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model | CMS
3. Application Window Opens Soon for CMS ACCESS Model | Healthcare Law Blog
4. CMS announces new value based payment model for technology-enabled care - Nixon Peabody
5. FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot | FDA
6. FDA Moves Toward Real-World Evaluation of Digital Devices With TEMPO - Pharmacally
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8. FDA announces digital health services pilot | AHA News
9. CMMI Launches Application Process for ACCESS Model - Dentons
10. Staying on TEMPO: Five Things for Digital Health Companies to Know - ArentFox Schiff
11. ACCESS + TEMPO: The 2-door entryway to faster digital health innovation - McDermott+
12. FDA opens a CMS-linked side door: Use of digital health devices before authorization - Hogan Lovells
13. New FDA Digital Health Pilot, Same FDA Enforcement Discretion - Morgan Lewis