MAHA ELEVATE submission package verification confirms V5.2 alignment and identifies open gaps
Source type:
obs· Harvested: 2026-05-04 · Original date: 2026-05-04T07:39:42.026Z Metadata:{"project":"maha-elevate-2027","type":"discovery","obs_id":65492}
obs/65492 · discovery · 2026-05-04T07:39:42.026Z
MAHA ELEVATE submission package verification confirms V5.2 alignment and identifies open gaps
Systematic verification of MAHA ELEVATE CMS-2W2-27-001 submission package confirmed alignment with V5.2 ACES Trial source of truth and identified remaining critical gaps 11 days before deadline. All 43 peer-reviewed evidence articles downloaded and validated with DOI/PMID verification. V5.2 15-page narrative established stratum-specific primary outcomes (HbA1c for cardiometabolic, BPI interference for chronic pain) with EQ-5D-5L as cross-stratum secondary, not sole primary. N=500 enrollment target (250/250 allocation) confirmed across pragmatic cluster-randomized design with up to 8 clinics. Herman 2026 Spine Medicare-perspective RCT provides cost-savings anchor at $421/participant/year. Key submission documents verified present in 07-submission/ including business assessment v6, budget narrative v4, organizational chart, all four required tables (G/H/I/J) at v3, SAP appendix stub, and DSMB charter draft. Critical blockers identified: entire 01-sf424/ directory empty (SF-424 application form, SF-424A budget form, Performance Site Location form all missing), all site CEHRT CHPL IDs marked PENDING in Table J, partner system MOUs not executed, DCC operator not finalized, applicant legal entity and AOR unresolved. Checklist projects 2026-05-15 23:59 ET deadline with internal target to upload 2026-05-13 for 48-hour buffer.
Concepts: [“what-changed”,“gotcha”,“problem-solution”]
Facts: [“All 43 peer-reviewed evidence PDFs downloaded and validated in 06-attachments/evidence-articles/ per DOWNLOAD_STATUS_2026-04-28.md”,“V5.2 narrative SOT at 07-submission/master-project-narrative-v5.2-15p_2026-05-01.docx uses stratum-specific primary outcomes HbA1c ≥0.5pp (cardiometabolic) and BPI interference ≥1.0 (chronic pain), not EQ-5D-5L as sole primary”,“Enrollment target N=500 confirmed (250 intervention, 250 control) across up to 8 planned clinics in 3 healthcare systems”,“Herman 2026 Spine (PMID 41493335) anchors Medicare cost savings at $421 per participant per year for acupuncture in chronic low back pain”,“Key submission documents present: business-assessment-v6, budget-narrative-v4, org-chart, Tables G/H/I/J v3, SAP-appendix-stub, DSMB-charter-draft”,“Critical gaps confirmed: 01-sf424/ directory empty (no SF-424, SF-424A, Site Location forms), CHPL IDs marked PENDING across all sites, partner MOUs not executed, DCC operator not finalized, applicant/AOR unresolved”,“Submission deadline 2026-05-15 23:59 ET with 11 days remaining as of verification date”]
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