GUIDELINE NOTE 173, INTERVENTIONS THAT ARE …



33289, 93264, C2624 CardioMEMS? – Implantable wireless pulmonary artery pressure monitor for heart failure monitoringEvidence: Brugts 2023, MONITOR-HF trialN=348 patients (176 Cardio-MEMS, 172 control)Median ejection fraction 30%Control was standard care in the Dutch healthcare systemNon-blindedThe primary efficacy endpoint was the mean change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scores from baseline to 12 months between groupsScores range from 0 to 100, with higher scores reflecting better health status.The secondary efficacy endpoint was the total number of heart failure hospitalisations (first and recurrent) and urgent visits with the necessity of intravenous diuretics during follow-upPatients in both groups had similar mean baseline KCCQ overall summary scores (55.8 [SD 23.3] in the CardioMEMS-HF group and 54.9 [22.3] in the standard care group; p=0.70)The mean change in KCCQ overall summary scores between baseline and 12 months among patients in the CardioMEMS-HF group was +7.05 (95% CI 2.77 to 11.33; p=0.0014), compared with –0.08 points among those in the standard care group (–3.76 to 3.60; p=0.97The total number of heart failure hospitalisations was 117 in the CardioMEMS-HF group and 212 in the control group, which corresponded to an event rate of 0.381 per patient-year in the CardioMEMS-HF group and 0.678 per patient-year in the control group. Hence, the rate of total heart failure hospitalisations was reduced by 44% (hazard ratio [HR] 0.56 [95% CI 0.38–0.84; p=0.0053Conclusions: The MONITOR-HF study showed that haemodynamic monitoring and subsequent individualised adjustment of diuretics and GDMT significantly improved QOL and reduced the number of heart failure hospitalisations.We acknowledge the limitations of an open-label design, as well as the absence of a device (or sham) in controls, which can be prone to bias in the QOL endpoint by unmaskingHajduczok 2022, systematic review and meta-analysis of remote monitoring for heart failure using implantable devicesN=11 RCTs (6196 patients)Compared implantable remote monitoring devices to standard careEndpoints: hospitalization, mortalityWhen comparing remote monitoring to standard of care, there was no significant reduction in mortality (RR 0.89 [95% CI 0.77–1.03]) or the composite of CV or HF hospitalizations (RR 0.98 [95% CI 0.81–1.19])Sensitivity analysis examining exclusively HF hospitalizations with data from 8 of the 11 RCTs included revealed no significant reduction in HF hospitalizations in the remote monitoring group compared to control (RR 0.97 [95% CI 0.74–1.24])Conclusion: Compared to standard of care, remote monitoring of physiologic parameters using implantable devices did not have a significant reduction in mortality or in the composite of CV or HF hospitalizations in patients with HF in the 11 RCTs included in this systematic review and meta-analysisExpert guidelines: AHA/ACC/HFSA 2022 CLINICAL PRACTICE GUIDELINE Management of Heart Failure:In selected adult patients with NYHA class III HF and history of a HF hospitalization in the past year or elevated natriuretic peptide levels, on maximally tolerated stable doses of GDMT with optimal device therapy, the usefulness of wireless monitoring of PA pressure by an implanted hemodynamic monitor to reduce the risk of subsequent HF hospitalizations is uncertain and provides uncertain value. COR 2b (weak), LOE B-R (moderate quality evidence from one or more RCTs)The CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure patients) trial reported a significant 28% reduction of HF-related hospitalizations after 6 months in patients randomized to an implanted PA pressure monitor compared with a control group. Patients had to have a HF hospitalization in the previous year and be on stable doses of a beta blocker and angiotensin-converting enzyme inhibitor (ACEi) (or angiotensin (II) receptor blocker [ARB]) if tolerated. The clinical benefit persisted after longer term follow-up and was seen in both subjects with reduced and preserved LVEF. However, CHAMPION was a nonblinded trial, and there was differential contact of study personnel with patients in the treatment arm, raising methodological concerns about the opportunity for bias to have influenced its results. In the recent GUIDE-HF (Haemodynamic-GUIDEed management of Heart Failure) study, hemodynamic-guided management of patients with NYHA class II to IV heart failure did not significantly reduce the composite endpoint rate of mortality and total HF events. The usefulness of noninvasive telemonitoring or remote monitoring of physiological parameters (eg, patient activity, thoracic impedance, heart rate) via implanted electrical devices (ICDs or CRT-Ds) to improve clinical outcomes remains uncertain. Further study of these approaches is needed before they can be recommended for routine clinical careOther payer policies: Aetna 2023: considers CardioMEMS to be experimentalCigna 2023: considers CardioMEMS to be experimentalAnthem BCBS 2023: The implantation of a pressure sensor into the pulmonary artery for the purpose of wireless ambulatory monitoring of heart failure and all other indications is considered?investigational and not medically necessaryUHC 2023: unproven interventionHERC staff summary: Implantable pulmonary artery pressure monitors have not been shown in meta-analyses to reduce hospitalizations due to heart failure or mortality. One recent study indicates that this technology may improve quality of life, but it is unclear if this finding is generalizable outside of the Dutch health care system. The expert guidelines in this field do not recommend use of this technology. The previous coverage guidance on this topic found concerns for harms. No private payer surveyed is covering these remote monitors. HERC staff recommendation: Update GN173 as shown belowGUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONSLine 654The following Interventions are prioritized on Line 654 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS:Procedure CodeIntervention DescriptionRationaleLast Review33289, 93264, C2624CardioMEMS? – Implantable wireless pulmonary artery pressure monitor for heart failure monitoringInsufficient evidence of effectivenessNovember, 2018 Coverage guidanceJanuary 2024HCPCS C9741 Right heart catheterization with implantation of wireless pressure sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation, and reportHCPCS C2624 Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system componentsLast reviewed at VbBS in October 2018. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. HERC Coverage GuidanceCardioMEMS? is not recommended for coverage for heart failure monitoring (weak recommendation).CODESDESCRIPTIONCurrent Prioritized List PlacementCPT Codes93451Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performedDiagnostic Procedures File93568Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for pulmonary angiography (List separately in addition to code for primary procedure)Diagnostic Procedures File93799Unlisted cardiovascular service or procedureAncillary Procedures File93297Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professionalDiagnostic Procedures File93299Interrogation device evaluation(s), (remote) up to 30 days; implantable loop recorder system, including analysis of recorded heart rhythm data, analysis, review(s) and report(s) by a physician or other qualified health care professionalDiagnostic Procedures FileHCPCS Level II CodesC9741Right heart catheterization with implantation of wireless pressure sensor in the pulmonary artery, including any type of measurement, angiography, imaging supervision, interpretation, and reportDiagnostic Procedures FileC2624Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system componentsNot on ListHERC Staff Recommendations: Place C2624 on Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITSPlace C9741 on Line 660, remove from the Diagnostic Procedures FileGUIDELINE NOTE 173, INTERVENTIONS THAT ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONSLine 660The following Interventions are prioritized on Line 660 CONDITIONS FOR WHICH CERTAIN INTERVENTIONS ARE UNPROVEN, HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS:Procedure CodeIntervention DescriptionRationaleLast ReviewC2624, C9741CardioMEMS? – Implantable wireless pulmonary artery pressure monitor for heart failure monitoringInsufficient evidence of effectivenessOctober 2018 Coverage guidance ................
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