{"id":"AIBD-0651","title":"CMS determines that Viz.ai ContaCT is a substantial clinical improvement because it shortens stroke-specialist notification, and approves add-on payments","summary":"CMS found that Viz.ai ContaCT shortens time to specialist notification for large vessel occlusion stroke; in routine use the median time to notification was 4.31 minutes.","date_observed":"2018-10-01","date_basis":"source information","date_precision":"month","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Viz.ai applied to the Centers for Medicare & Medicaid Services (CMS) for a new technology add-on payment for ContaCT, software that reads CT angiograms of the brain and alerts a stroke specialist to a suspected large vessel occlusion. ContaCT became commercially available in October 2018. In the proposed rule, CMS questioned whether the evidence showed that shorter notification times improve outcomes, and the company then submitted more data. In a retrospective test on past scans that supported its FDA authorization, the mean time from scan to specialist notification was 7.32 minutes with ContaCT and 58.72 minutes in usual care. Viz.ai reported that across 4,763 patients in six months of routine use, the median time to notification was 4.31 minutes. Unpublished single-center reviews at hospitals in Colorado, Georgia and Tennessee reported average reductions in door-to-puncture time of 24, 30 and 44 minutes, and a Mount Sinai cohort of 42 thrombectomy patients had lower stroke severity scores after implementation. In the final rule published on 18 September 2020, CMS determined that ContaCT represents a substantial clinical improvement because it shortens time to notification, and it approved add-on payments for fiscal year 2021. CMS based its finding on information that the applicant provided, and the hospital comparisons were small single-site cohorts.","category":"general benefit","unexpected":false,"purpose":"ContaCT was built to alert a stroke specialist to a suspected large vessel occlusion in parallel with the usual radiology read. Faster notification is that purpose.","system":"ContaCT (Viz LVO algorithm with Viz Hub and Viz View)","model_version":null,"developer":"Viz.ai, Inc.","deployer":"US hospitals using ContaCT, including SkyRidge Medical Center, Wellstar, Methodist Le Bonheur Healthcare and Mount Sinai Health System","location":"United States","domain":"Healthcare","segment":null,"benefit_type":"Reduced Task Time","taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":2,"reason":"Viz.ai data showed a median of 4.31 minutes from scan to specialist notification across 4,763 patients in routine use."},{"group":"personal","depth":2,"reason":"Hospital comparisons reported average reductions in door-to-puncture time of 24, 30 and 44 minutes for thrombectomy patients."}],"ai_role":{"status":"unassessed","statement":"The FDA comparison used past scans, so the alerts did not reach a treating team. The routine-use data have no comparison group, and the hospital before and after comparisons do not rule out other changes to stroke care."},"evidence":[{"kind":"regulatory document","citation":"Centers for Medicare & Medicaid Services. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System; final rule. Federal Register 85 FR 58432, 18 September 2020 (document 2020-19637).","title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System (FY 2021 final rule)","url":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital","date":"2020-09-18","written_by":"independent","quote":"we have determined that ContaCT represents a substantial clinical improvement over existing technologies because, based on the information provided by the applicant, the technology shortens time to notification"},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration. De Novo classification request for ContaCT (DEN170073): decision summary. 13 February 2018.","title":"De Novo classification request for ContaCT (DEN170073)","url":"https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf","date":"2018-02-13","written_by":"independent","quote":"The clinical benefit is that the device identifies patients who may benefit from rapid intervention by a neurovascular specialist."}],"replication":{"produced_by":["The software analyzed CT angiograms of the brain and alerted specialists in parallel with the radiology read.","Specialists received alerts and images through the Viz Hub and Viz View mobile tools."],"must_hold":["A thrombectomy team is ready to act on alerts.","Scans meet the device's acquisition requirements."],"echoes":[{"date":"2019-07-01","setting":"Wellstar Hospital, Georgia: 120 patients, July 2018 to June 2019 against July 2019 to June 2020","model_version":null,"outcome":"recurred","source":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital"},{"date":"2019-10-01","setting":"Mount Sinai Health System primary stroke center, New York: 42 thrombectomy patients before and after ContaCT","model_version":null,"outcome":"recurred","source":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital"},{"date":null,"setting":"SkyRidge Medical Center, Colorado: 16 thrombectomy patients before and 16 after ContaCT","model_version":null,"outcome":"recurred","source":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital"}]},"paired_incident":null,"headline":"Medicare's payment review credits *ContaCT* with faster stroke alerts","metric":"the median time to notification was 4.31 minutes","comparator":{"against":"Usual-care notification time in the retrospective test on past scans that FDA reviewed, as cited by CMS","before":"58.72 minutes mean","after":"7.32 minutes mean","basis":"measured","quote":"According to the applicant, the average time to specialist notification for ContaCT was 7.32 minutes [95% CI: 5.51, 9.13] whereas time to notification for standard of care workflow was 58.72 minutes [95% CI: 46.21, 71.23].","url":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital"},"later":null,"value":null,"developer_country":"United States","deployer_country":"United States","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-10-29","change":"Added the case.","source":"https://www.federalregister.gov/documents/2020/09/18/2020-19637/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the-long-term-care-hospital","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: two independent regulatory documents. 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