Coverage Determinations according to IOM 100-04 Medicare Program Integrity Manual, Chapter 13 – Local Coverage Determinations and Change Request 10901, effective 01/08/2019, are listed below.
0042T
Cerebral perfusion analysis using computed tomography with contrast administration, including post-processing of parametric maps with determination of cerebral blood flow, cerebral blood volume, and mean transit time
Computed Tomographic Perfusion (CTP) (using automated post-processing software algorithmic analysis) is medically reasonable and necessary in patients with acute ischemic stroke (AIS) caused by unilateral large vessel occlusion (LVO) in the proximal anterior circulation evaluated at stroke centers, to aid in selection for endovascular mechanical thrombectomy (EVT) if all of the following conditions are fulfilled:
- Intracranial internal carotid artery (ICA) OR middle cerebral artery (MCA) occlusion
- The medical record documents the patient is being considered for endovascular mechanical thrombectomy (EVT) and does not have contraindications to the EVT (based on DAWN or DEFUSE3 trial criteria)
- Treatment (femoral puncture) can be started within 6-24 hours of the last time known to be at neurologic baseline
Computed Tomographic Perfusion (CTP) accuracy: A 2020 systematic review aimed to evaluate the diagnostic accuracy of CTP in the prediction of hemorrhagic transformation and patient outcome in AIS reported CTP sensitivity as 85.9%, specificity of 73.9%, positive predictive value 60.3% and negative predictive value of 92.9%.11 A 2017 systematic review identified 27 studies with a total of 2168 patients. The pooled sensitivity of CTP for acute ischemic stroke was 82% (95% CI 75–88%), and the specificity was 96% (95% CI 89–99%). They determined CTP was more sensitive than Non-contrast Computerized Tomography (NCCT) and had a similar accuracy with Computed tomography angiography (CTA), but also that the evidence was not strong, and there is a need for high-quality evidence to confirm results.18 Older systematic reviews report mixed results with a wide range in sensitivity and specificity of CTP for detection of acute ischemic stroke (AIS).18 A 2019 systematic review and meta-analysis comparing imaging modalities for evaluation of AIS concludes that while CTP was more accurate than NCCT for detection of AIS, it was less accurate than diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) (sensitivity 82%, specificity 96% vs. sensitivity 15-86%, specificity 100%, respectively).19 DWI is considered the gold standard for imaging diagnosis of acute ischemia and more accurate than NCCT, CTA, and CTP to estimate or infer the size of core and penumbra.20 However, NCCT is considered the current standard for stoke evaluation as MRI use in emergency settings may be limited, as well as several contradictions for MRI.21 Most studies evaluated in these systematic reviews were retrospective with variability in inclusion and exclusion criteria, outcomes reported, and sampling procedures, which introduces a high risk for bias, heterogenicity, and overall reduced quality of evidence. The evidence for routine use of CTP for evaluation for AIS is low quality and there is a need for high-quality evidence to determine the role it may play in AIS evaluation.
Hemorrhagic transformation (HT) zone: 2020 systematic review reported prediction of the HT could guide decision making in regard to consideration at thrombolysis decision point and concludes CTP is a useful prognostic tool for clinicians at the point of intervention decision making for AIS.11 This review, however, consisting of three prospective and nine retrospective studies, is subject to inaccuracy given the risk of bias and a high degree of heterogenicity in the selected studies. Another small retrospective study with 46 patients who received recanalization therapy also concluded usefulness in CTP as a predictor of HT.22 On the contrary, a large prospective trial with 545 patients treated with IV tPA or thrombectomy had CTP at admission, and day three follow-up looked at the ability of the technology to predict HT (by measurement of the blood brain barrier permeability (BBBP). While univariate analysis associated BBBP measured by CTP as an independent predictor of HT, the multivariant analysis did not reproduce those findings, and the addition of BBBP as a variable did not change the AUC (0.77, 95% CI 0.71–0.83) of the model. The authors concluded BBBP measured by CTP did not improve prediction of HT, and improvements are needed before being considered “a useful addition to decision making”.23 At this point, there are mixed results, lack of high-quality data, and lack of standardized scoring to determine treatment threshold to support the use of CTP for prediction of HT zone.
Evaluation for Endovascular mechanical thrombectomy (EVT): There are two level I randomized controlled trials (RCTs), which both conclude CTP is useful in determining eligibility for EVT in the late time period (6-24 hr.) of an acute (<24 hr.) ischemic stroke (AIS). The DAWN trial (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo) studied whether patients with a clinical deficit that is disproportionately severe relative to the infarct volume may benefit from late EVT.8 Their protocol included stringent inclusion and exclusion criteria. All patients had evidence of occlusion in internal carotid artery (ICA) with computed tomography (CT) or MRI imaging with CTP or DWI to determine infarct volume. Patients were randomly assigned to EVT plus standard medical management (MM) (N=107, mean age 69.4 yr.) or to MM alone (N=99, mean age 70.7 yr.). Median National Institutes of Health Stroke Scale (NIHSS) score was 17 (moderate to severe stroke) for both groups. The trial was stopped for efficacy at the first interim analysis. At 90 days, the rate of functional independence, as defined by a score of 0-2 on the modified Rankin scale (mRS) of 0-6, was greater for EVT than MM (49% versus 13%; adjusted difference, 33%; 95% CI, 21–44; posterior probability of superiority >0.999). The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the EVT group and 3% in the MM group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).
The DEFUSE 3 trial (Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution) was a multicenter, randomized, open-label trial randomizing patient with occlusion in the ICA or middle cerebral artery (MCA) based on computed tomography angiography (CTA) or magnetic resonance angiogram (MRA). Perfusion study with CTP or MRI diffusion was used to determine perfusion-core mismatch and maximum core size as imaging criteria to select patients for late EVT.3 Patients were randomly assigned to EVT plus standard MM or standard MM alone. The trial was conducted at 38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (EVT N=92, median age 70; MM N=90, median age 71). The median NIHSS score was 16 (moderate to severe stroke) for both groups. The EVT group showed a benefit in functional outcome at 90 days (mRS score 0–2, 44.6% versus 16.7%; RR, 2.67; 95% CI, 1.60–4.48; P<0.0001). The 90-day mortality rate trended in favor of EVT (14% vs. 26% (P=0.05)), and there was no significant difference between groups in the rate of symptomatic intracranial hemorrhage (7% and 4%) or serious adverse events (43% and 53%). In a subgroup analysis, both the favorable outcome rate and treatment effect did not decline in transfer patients compared to direct-admission patients.24
Both trials were designed to assess the effectiveness of EVT within 6-24 hours, but also provided evidence on the utility of CTP for aiding in management decisions. A subsequent prospective review25 and retrospective registry26 analysis also support the value of CTP in late period EVT eligibility assessment.
While DWI is considered the gold standard, CTP has the advantage of more availability, faster acquisition, and a similar estimate of mismatch, therefore becoming the dominant advanced imaging tool for identifying the core and penumbra.20 CTP was used as an acceptable modality for triage for EVT in both the DAWN and DEFUSE3 studies and appear to be useful in aiding patient selection for thrombectomy (risk ratio for functional independence at day 90 was CPT 2.50, 95%CI: 1.32 to 4.75 and MRI 3.17, 95%CI: 1.35 to 7.43).21,27 Results, however, must still be interpreted with caution. A 2020 retrospective study that evaluated patients undergoing CTP for EVT triage included 176 consecutive patients undergoing CTP and CTA. Automated calculations were performed with proprietary software, and failures were reprocessed manually. The primary outcome was postprocessing failure, defined as the presence of perfusion abnormalities caused by artifact and verified on follow-up images, and was reported in 11% of cases (20/176). Causes included severe motion, streak artifact, and poor arrival of contrast. Half of the failures (n=6) led to erroneous ischemic core volumes that may have resulted in different treatment decisions if the CTP results had not been corrected. The authors conclude that results from automated CPT should be interpreted with caution, and failures should be recognized and corrected to ensure appropriate management decisions are made.28 In most cases, the key to improved diagnostic certainty is to interpret the CTP, not in isolation, but in conjunction with the NCCT, CTA, NIHSS, and clinical history.20
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0525T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; complete system (electrode and implantable monitor)
0526T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; electrode only
0527T Insertion or replacement of intracardiac ischemia monitoring system, including testing of the lead and monitor, initial system programming, and imaging supervision and interpretation; implantable monitor only
0528T Programming device evaluation (in person) of intracardiac ischemia monitoring system with iterative adjustment of programmed values, with analysis, review, and report
0529T Interrogation device evaluation (in person) of intracardiac ischemia monitoring system with analysis, review, and report
0530T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; complete system (electrode and implantable monitor)
0531T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; electrode only
0532T Removal of intracardiac ischemia monitoring system, including all imaging supervision and interpretation; implantable monitor only.
Holmes et al.: The randomization technique is not described. The sample size is not justified. The investigation is for six months with an additional six month follow-up. The authors state that more work is needed to understand the false positive and false negative rates and the actual clinical benefit; these are important issues in determining coverage.
Gibson et al.: The randomization technique is not described. The authors state, “Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest…” Obviously, this is too preliminary to support coverage.
Fischell et al.: This is a non-randomized feasibility study.
Correspondence: Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Testimonials indicating such limited acceptance are not sufficient evidence of general acceptance by the medical community.
Summary of Safety and Effectiveness Data: Is not able to be utilized to support coverage.
User’s Guide, Manual, and Programming Guide: Is not able to be utilized to support coverage.
ACC/AHA Guidelines: These are not germane to the issue of coverage of a specific device, and is not current information, dated 2004.
Mirzaei et al.: This reviewer did not see the relevance of this article related to your request.
DeVon et al.: This article describes a weak selection methodology and seems directed to providing guidance for nursing education of patients. This reviewer did not see the relevance to coverage of a specific device.
Sheifer et al.: This article does not seem to address the issue at hand and is not current information, dated 2001.
Flynn et al.: This case series does not seem to address the issue at hand related to your request.
Gersch et al.: This article does not address the issue at hand related to your request.
Kwong et al. with correction: Case series apparently not germane to question at hand related to your request.
Moser et al.: Consensus statement that does not address the issue at hand related to your request.
Sanchez et al.: This case-control can be used to generate hypotheses for further study, but it cannot address the issue at hand.
Wasson et al.: This is an investigation of the quality of life burden of post-traumatic stress disorder due to acute coronary syndrome. This reviewer does not see its relevance to the issue at hand
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Maldonado TS, Musquera NJ, Lin P, Bellosta R, Barfield M, Moussa A, et al. Gore Iliac Branch Endoprosthesis for Treatment of Bilateral Common Iliac Artery Aneurysms. Journal of Vascular Surgery 2018, July; 68(1): 100-8.1 The authors do not state a hypothesis. This is a feasibility study. The selection criteria are vague, and the authors describe it as “highly individualized and selective.” (Page 107) The sample size is not justified. There is no control group. The assessment was apparently unmasked. The follow-up was not standardized, and the authors describe it as “non-standard and relatively short.” (Page 107) The average follow-up was only six months.
The authors state, “Limitations of the study include its retrospective design, which limits the ability to collect important clinical end points reliably, and the absence of core laboratory validation of the available imaging. In particular, impotence and buttock claudication, although reported in this study, are difficult end points to capture without a prospective design. Indeed, only 28 of 47 patients had preoperative history of sexual dysfunction recorded. In addition, the follow-up is nonstandardized and relatively short (mean, 6.5 months; range, 1-36 months). Longer follow-up is needed to determine the durability of the IBE device with regard to patency rates and efficacy. Finally, this study captures only patients who were deemed candidates for bilateral IBE implantation by individual practitioners. This process is highly individualized and subjective. Moreover, we caution that nearly half of all cases in this study were performed outside the IFU [instructions for use] for this device.”
The requestor of the reconsideration submitted three articles that appear to be the same article. One is the article as published; one is apparently a pre-publication proof; and one is in a different format with the title and full list of authors removed. However, this third article reads the same as the others in the important aspects. None of the three versions supports coverage.
Manuga J, Sullivan T, Garberich R, Alden P, Alexander J, Skeik N, et al. Single-center Experience with Complex Abdominal Aortic Aneurysms Treated by Open or Fenestrated/Branching Endografts. Journal of Vascular Surgery 2018; in press: 1-11.2 The authors do not state a hypothesis. This is a retrospective review. The sample size is not justified. The process of the allocation of patients is not described other than to say that operative subjects were “those not amenable to standard EVAR [endovascular aneurysm repair] because of short neck or no neck (juxtarenal or pararenal) and those extending above the renal arteries (suprarenal)” (Page 2) and endovascular subjects were “high-risk patients…provided they had no anatomic limitations precluding them from being offered such a repair.” (Page 2) The assessment of outcome was apparently non-blinded. There was not a systematic follow up, and the mean follow up was 17 months for the endovascular graft.
The authors state, “The strength of this study resides in that it gives a glimpse into the performance of the F/B-EVAR [fenestrated/branched endovascular aneurysm repair] outside major academic centers compared with OR [open repair]. However, there are several limitations, with the first being the lack of randomization and short follow-up interval in the F/B-EVAR group.” (Page 9, emphasis added).
The stated strength of study is not germane to the question of coverage, but the limitations are.
Schneider DB, Matsumura JS, Lee JT, Peterson BG, Chaer RA, Oderich GS. Prospective, Multicenter Study of Endovascular Repair of Aortoiliac and Iliac Aneurysms using the Gore Iliac Branch Endoprosthesis. Journal of Vascular Surgery 2017; in press: 1-11.3 The authors do not state a clear a priori hypothesis. The inclusion/exclusion criteria are clear, but the sample size is not justified. There is no control group. The patients are not well described. The assessment was apparently non-masked. The follow up was six months.
The authors state, “There was no control arm or randomization to allow comparisons between EVAR [endovascular aneurysm repair] with the IBE [iliac branch endoprosthesis] device and EVAR with internal iliac artery coil embolization. The 26% incidence of now-onset buttock claudication after contralateral internal iliac artery sacrifice in the patients who underwent staged procedures vs 0% on the IBE side strongly suggests that the IBE can prevent new-onset buttock claudication. However, in the absence of randomization, selection bias cannot be excluded.
“In addition, because our follow-up data are limited to 6 months, the long-term durability of AIA or CIAA repair with the IBE device remains unknown.” (Page 9)
Schneider DB, Milner R, Heyligers JMM, Chakfe N, Matsumura J. Outcomes of the Gore Iliac Branch Endoprosthesis in Clinical Trial and Real-world Registry Settings. Journal of Vascular Surgery 2019; 69 (2): 367-77.4 There is no explicit hypothesis. This is a retrospective study. The inclusion criteria are a signed consent, unspecified indications for endovascular therapy, and local age requirements. The sample size is not justified. Follow up was according to investigator discretion, only certain outcomes were captured, and the average follow up was six months. The subjects were in studies of different designs and data collection methods. There was no adjustment for multiple hypotheses testing. The authors describe these limitations and more at length, concluding that the findings “require confirmation from future prospective studies”. (Pages 375-6)
GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE Device). Federal Register 2017, August 14; 82(155): 38108-9.5 This discusses the application of W. L. Gore and Associates, Inc. for new technology add-on payments for the GORE® EXCLUDER® Iliac Branch Endoprosthesis for fiscal year 2017. It is does not provide medical evidence in support of coverage
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MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patient with one of the following:
- Essential Tremor (ET)- defined as refractory to at least two trials of medical therapy, including at least one first-line agent
- Tremor-Dominant Parkinson’s disease (TDPD) (and both a & b)
- refractory (or intolerant) to levodopa or levodopa equivalent daily dosage (LEDD) ≥ 900 mg
- On-medication Unified Parkinson’s Disease Rating Scale (UPDRS) ratio of the mean score for tremor items (items 16, 20, and 21) to the mean postural instability/gait disorder score (items 13-15, 29, and 30) of ≥ 1.5
And all of the following:
- Moderate to severe postural or intention tremor of the dominant hand (defined by a score of ≥2 on the Clinical Rating Scale for Tremor (CRST)
- Disabling tremor (defined by a score of ≥2 on any of the eight items in the disability subsection of the CRST
- Not a surgical candidate for deep-brain stimulation (DBS) (e.g., advanced age, anticoagulant therapy, or surgical comorbidities
Exclusion from Coverage:
- Treatment of head or voice tremor
- Bilateral thalamotomy
- Following conditions:
- A neurodegenerative condition other than Parkinson’s disease
- Unstable cardiac disease
- Untreated coagulopathy
- Risk factors for deep-vein thrombosis
- Severe depression, i.e., a score greater than or equal to 20 on the Patient Health Questionnaire 9 (PHQ-9)
- Cognitive impairment defined by a score of less than 24 on the Mini-Mental Status Examination
- Previous brain procedure (transcranial magnetic stimulation, deep brain stimulation, stereotactic lesioning, or electroconvulsive therapy)
- A skull density ratio (the ratio of cortical to cancellous bone) of <0.45 ± 0.05 as calculated from the screening CT.
- MRI contraindication
- Drug-induced Parkinsonism
- History of seizures, brain tumor, intracranial aneurysm or arteriovenous malformation requiring treatment
- pregnancy
Essential tremor (ET)
Elias, JW, Lipsman N, Ondo WG,et al conducted a randomized clinical trial with masked assessment and recognized outcome parameter with a one year follow up.2 There is a relatively high adverse event rate, but it is a relatively non-invasive intervention compared to the currently available interventions. It does provide some criteria to determine the proper population for coverage.
Chang, JW, Park CK, Lipsman N, et al provided a two-year follow up on the cohort of the above investigation.1 The therapeutic effect does seem to be maintained and there were no apparent late adverse events. There was a 12% drop out rate, and the authors acknowledged the rate and accounted for the dropouts.
Tremor-Dominant Parkinson’s disease (TDPD)
Tremor is a common motor feature of Parkinson disease (PD), and TDPD is a clinical subtype distinct from the akinesia/rigidity (AR) and postural instability/gait disorder subtypes. This subtype may be more resistant to dopamine-replacement therapy than other motor symptoms. DBS and traditional thalamic lesioning are accepted treatments of motor symptoms of PD. Several small observational studies also demonstrated efficacy of MRgFUS thalamotomy in TDPD out to one year.5-7, 9
A small prospective, sham-controlled RCT looked at the safety and efficacy of unilateral MRgFUS thalamotomy at 3 and 12 months in patients with TDPD3. Twenty-seven patients (median age 67.8 years; interquartile range [IQR], 62.1-73.8) were randomized (2:1) to MRgFUS (20) vs. sham (7). Predefined primary outcomes were safety and difference in improvement between groups at 3 months in the on-medication treated hand tremor CRST subscore. Secondary outcomes included descriptive results of UPDRS scores and quality of life measures. Three-month on-medication median tremor scores improved 62% (17 to 4.5; IQR, 22%-79%) in the treatment group, and 22% (23 to 17; IQR, −11% to 29%) in the sham group (P = .04). Secondary outcomes showed non-statistical improvement trends in the treatment group. At 3 months, 6 sham patients crossed-over to MRgFUS treatment. Three months after crossover the median baseline CRST score improved from 21 to 5.5, like the 3 months outcomes in the group originally allocated to treatment. One-year follow-up of 14 treatment and 5 sham crossover patients demonstrated CRST score maintenance. Early in the study, heating of the internal capsule resulted in 2 cases (8%) of mild hemiparesis, which improved and prompted monitoring of an additional axis during magnetic resonance thermometry. Other persistent adverse events were orofacial paresthesia (20%), finger paresthesia (5%), and ataxia (5%). A sub-analysis reported no change in cognitive, mood, or behavioral perspective at 3 and 12 months.
On 12/16/2018, the Exablate MRgFUS device FDA indication was expanded to include unilateral thalamotomy (ventralis intermedius) treatment of TDPD with medication-refractory tremor in patients at least age 30.4.
0501T-0504T
Douglas PS, DeBruyne P, Pontone G, Patel MR, Norgaard BL, Byrne RA, et al. 1-year Outcomes of FFRct-Guided Care in Patients with Suspected Coronary Disease. The American College of Cardiology 2016, August 2; 68(5): 435-45. This prospective, cohort study demonstrated a lower rate of coronary angiography without obstructive coronary artery disease and indicated that this technology may provide significant cost savings.
Douglas PS, Pontone G, Hlatky MA, Patel MR, Norgaard BL, Byrne RA et al. Clinical Outcomes of Fractional Flow Reserve by Computed Tomographic Angiography-Guided Diagnostic Strategies vs. Usual Care in Patients with Suspected Coronary Artery disease: The Prospective Longitudinal Trial of FFRct: Outcome and Resource Impacts Study. The European Heart Journal 2015; doi:10.1093/eurheartj/ehv444. This prospective trial demonstrated that FFRct was associated with a lower rate of coronary artery catheterization without obstructive coronary artery disease allowing for more effective triage of patients for invasive procedures.
National Institute for Health Care Excellence. Heart Flow FFRct for Estimating Fractional Flow Reserve from Coronary CT Angiography. nice.org.uk/guidance/mtg32. This review summarized the evidence extant to date of publication and asserted that this diagnostic intervention was likely to provide a cost savings. The search and selection methods are not described.
Patel, M. R., et al. (2017), ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease. Journal of the American College of Cardiology. 69(17), 2212-2241. This article is largely irrelevant to the reconsideration, but it does provide useful background including the interpretation of the fractional flow reserve and its role in clinical decision making. The article does state that FFRct is an emerging technology.
Fractional Flow Reserve computed tomography (FFRct) is a non-invasive method of using fluid dynamics physiologic stimulation software analysis to assess the severity of coronary artery disease. It is reimbursable with documentation of medical necessity.