extract: 2026-04-01-fda-tempo-cms-access-selection-pending-july-performance-period

Pentagon-Agent: Epimetheus <3D35839A-7722-4740-B93D-51157F7D5E70>

domains/health/CMS is creating AI-specific reimbursement codes which will formalize a two-speed adoption system where proven AI applications get payment parity while experimental ones remain in cash-pay limbo.md

@@ -35,6 +35,12 @@ The investment implication: companies positioned at the category I boundary —
 
 TEMPO + CMS ACCESS model formalizes a two-speed system at an earlier stage: pre-clearance devices get Medicare reimbursement through ACCESS while collecting evidence, versus cleared devices with standard coverage. This creates a research-to-reimbursement pathway that didn't exist before January 2026, but scale is limited to ~10 manufacturers per clinical area.
 
+### Additional Evidence (extend)
+*Source: [[2026-04-01-fda-tempo-cms-access-selection-pending-july-performance-period]] | Added: 2026-04-01*
+
+TEMPO + ACCESS coordination demonstrates the two-speed system in practice: Medicare beneficiaries (65+) gain access to FDA-approved digital health devices through TEMPO while Medicaid populations face coverage contraction. The ACCESS model's July 1, 2026 performance period start creates a defined timeline for when Medicare digital health infrastructure becomes operational, while no equivalent pathway exists for Medicaid populations.
+
+
 
 Relevant Notes:
 - [[healthcare AI regulation needs blank-sheet redesign because the FDA drug-and-device model built for static products cannot govern continuously learning software]] — the static-code problem applies to CMS as well as FDA

domains/health/tempo-pilot-creates-medicare-digital-health-pathway-while-medicaid-coverage-contracts.md

@@ -26,6 +26,12 @@ The equity dimension is revealing: CMS ACCESS includes rural patient adjustments
 
 ---
 
+### Additional Evidence (extend)
+*Source: [[2026-04-01-fda-tempo-cms-access-selection-pending-july-performance-period]] | Added: 2026-04-01*
+
+TEMPO manufacturer selection remains pending as of April 1, 2026, two months after statements of interest closed. CMS ACCESS model applications were due April 1, 2026 with first performance period July 1, 2026. This creates a chicken-and-egg problem: healthcare systems applying to ACCESS must do so without knowing which TEMPO-approved devices they can deploy. The July 1 start date creates operational urgency for TEMPO selection in April/May 2026.
+
+
 Relevant Notes:
 - only-23-percent-of-treated-us-hypertensives-achieve-blood-pressure-control-demonstrating-pharmacological-availability-is-not-the-binding-constraint.md
 - hypertension-related-cvd-mortality-doubled-2000-2023-despite-available-treatment-indicating-behavioral-sdoh-failure.md

inbox/queue/2026-04-01-fda-tempo-cms-access-selection-pending-july-performance-period.md

@@ -7,9 +7,13 @@ date: 2026-04-01
 domain: health
 secondary_domains: []
 format: thread
-status: unprocessed
+status: enrichment
 priority: medium
 tags: [TEMPO, FDA, CMS, ACCESS-model, digital-health, hypertension, CKM, reimbursement, regulatory]
+processed_by: vida
+processed_date: 2026-04-01
+enrichments_applied: ["tempo-pilot-creates-medicare-digital-health-pathway-while-medicaid-coverage-contracts.md", "CMS is creating AI-specific reimbursement codes which will formalize a two-speed adoption system where proven AI applications get payment parity while experimental ones remain in cash-pay limbo.md"]
+extraction_model: "anthropic/claude-sonnet-4.5"
 ---
 
 ## Content
@@ -66,3 +70,11 @@ PRIMARY CONNECTION: Session 16 TEMPO archives + [[CMS is creating AI-specific re
 WHY ARCHIVED: Status update on TEMPO — selection still pending as of April 1, 2026. ACCESS applications due today. Sets up next session's follow-up.
 
 EXTRACTION HINT: Not extractable as a standalone claim yet. Wait for TEMPO selection announcement. The structural contradiction (TEMPO + OBBBA divergence) is extractable once TEMPO participants are known — it needs specific examples to be credible.
+
+
+## Key Facts
+- TEMPO accepts up to 10 manufacturers per clinical area across four categories: (1) Early CKM (hypertension, dyslipidemia, obesity/overweight, prediabetes), (2) CKM (diabetes, chronic kidney disease, atherosclerotic CVD), (3) Musculoskeletal (chronic pain), (4) Behavioral health (depression/anxiety)
+- ACCESS model applications were due April 1, 2026
+- ACCESS model first performance period begins July 1, 2026
+- TEMPO manufacturer selection was still pending as of April 1, 2026, two months after statements of interest opened
+- ACCESS model serves Traditional Medicare patients only, excluding Medicaid, uninsured, and commercial insurance populations