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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CY 2022 final rule with comment period). Federal Register 86 FR 63458, 16 November 2021 (document 2021-24011), section IV.A.2, AngelMed Guardian System, 86 FR 63583-63589.","title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CY 2022 final rule)","url":"https://www.govinfo.gov/content/pkg/FR-2021-11-16/html/2021-24011.htm","date":"2021-11-16","written_by":"independent","quote":"Given the additional endpoints evaluated in the expanded analysis that specifically show faster visits for real events while not increasing unnecessary emergency department visits, we agree that the Guardian[supreg] system meets the substantial clinical improvement criterion"},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data: AngelMed Guardian System, premarket approval P150009. Approval order 9 April 2018.","title":"Summary of Safety and Effectiveness Data (SSED): AngelMed Guardian System (P150009)","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150009B.pdf","date":"2018-04-09","written_by":"independent","quote":"The AngelMed device improves diagnostic accuracy of ACS in a clinically meaningful portion of the intended use population, and the risks associated with use of the device are acceptable."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1006-source-0001","AIBD-1006-source-0002"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CY 2022 final rule with comment period). Federal Register 86 FR 63458, 16 November 2021 (document 2021-24011), section IV.A.2, AngelMed Guardian System, 86 FR 63583-63589.","title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs (CY 2022 final rule)","url":"https://www.govinfo.gov/content/pkg/FR-2021-11-16/html/2021-24011.htm","date":"2021-11-16","written_by":"independent","quote":"Given the additional endpoints evaluated in the expanded analysis that specifically show faster visits for real events while not increasing unnecessary emergency department visits, we agree that the Guardian[supreg] system meets the substantial clinical improvement criterion"},{"kind":"regulatory document","citation":"U.S. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data: AngelMed Guardian System, premarket approval P150009. Approval order 9 April 2018.","title":"Summary of Safety and Effectiveness Data (SSED): AngelMed Guardian System (P150009)","url":"https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150009B.pdf","date":"2018-04-09","written_by":"independent","quote":"The AngelMed device improves diagnostic accuracy of ACS in a clinically meaningful portion of the intended use population, and the risks associated with use of the device are acceptable."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"CMS found that Guardian alarms got heart attack patients to hospital faster. In the trial, median arrival took 51 minutes with alarms on and 30.6 hours with alarms off.","account":"Angel Medical Systems applied to the Centers for Medicare & Medicaid Services (CMS) for transitional pass-through payment for its AngelMed Guardian System. The implant alarms the patient when the heart's ST segment shifts from the patient's baseline over the prior 24 hours. FDA approved it on 9 April 2018. In the ALERTS trial, 907 implanted patients were randomized to active or deactivated alarms. At the 7-day look-back window, median time to arrival at a medical facility was 51 minutes for treated patients and 30.6 hours for controls. The composite primary endpoint was not statistically significant. An expanded analysis that FDA proposed added follow-up from after the randomized period. In it, median arrival for acute coronary events was 1.7 hours with alarms on and 8.0 hours with alarms off. In its final rule of 16 November 2021, CMS agreed that the Guardian meets the substantial clinical improvement criterion and approved pass-through payment from 1 January 2022. The figures come from the maker's trial. In March 2016 an FDA advisory panel had voted 12-0 that there was no reasonable assurance of effectiveness."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"AngelMed Guardian System"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"CMS finds that the AngelMed Guardian implant's alarms brought heart attack patients to hospital faster and approves Medicare pass-through payment","headline":"Medicare credits the *Guardian* implant with faster heart attack visits"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["af2ca2617d93f7667d7992c2b660b43112e5928bbdc7d7ac96a205e906be5c3e"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Angel Medical Systems applied to the Centers for Medicare & Medicaid Services (CMS) for transitional pass-through payment for its AngelMed Guardian System. The implant alarms the patient when the heart's ST segment shifts from the patient's baseline over the prior 24 hours. FDA approved it on 9 April 2018. In the ALERTS trial, 907 implanted patients were randomized to active or deactivated alarms. At the 7-day look-back window, median time to arrival at a medical facility was 51 minutes for treated patients and 30.6 hours for controls. The composite primary endpoint was not statistically significant. An expanded analysis that FDA proposed added follow-up from after the randomized period. In it, median arrival for acute coronary events was 1.7 hours with alarms on and 8.0 hours with alarms off. In its final rule of 16 November 2021, CMS agreed that the Guardian meets the substantial clinical improvement criterion and approved pass-through payment from 1 January 2022. The figures come from the maker's trial. In March 2016 an FDA advisory panel had voted 12-0 that there was no reasonable assurance of effectiveness.","replication":{"produced_by":["The implant sensed the heart's electrical signal through a lead in the right ventricle and compared ST-segment changes with the patient's baseline over the prior 24 hours.","When it detected an abnormal shift, the implant vibrated and an external device flashed and beeped.","Patients were told to seek urgent care when the alarm went off, even without symptoms."],"must_hold":["The patient has had a prior acute coronary syndrome event and remains at high risk of another.","The patient can feel the implant's vibration and respond to the alarms.","Patients still act on symptoms when no alarm sounds."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"8b09b59398f250fa632abd4c89f01b35643dd1565d1e3ff904ae1c0798a8e352"}