SUPERSEDED Local Coverage Determination (LCD)

Category III Codes

L35490

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35490
Original ICD-9 LCD ID
Not Applicable
LCD Title
Category III Codes
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35490
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/27/2023
Revision Ending Date
03/27/2024
Retirement Date
N/A
Notice Period Start Date
04/28/2022
Notice Period End Date
06/11/2022

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description

All references to deleted code 0254T were removed. References for coverage for coronary fractional flow reserve were removed as they are longer applicable to this LCD.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Social Security Acts

  • Title XVIII of the Social Security Act (SSA): Section 1862(a) (1) (A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
  • Title XVIII of the Social Security Act Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
  • Title XVIII of the Social Security Act Section 1862(a) (1) (D) refers to limitations on items or devices that are investigational or experimental.

CMS IOM Citations

  • CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 14- Medical Devices, Section 10, Coverage of Medical Devices.
  • CMS Publication 100-03 Medicare Benefit Policy Manual, Chapter 1, Part 1, Section 20.4 Implantable Automatic Defibrillators.
  • CMS Publication 100-03 Medicare Benefit Policy Manual, Chapter 1, Part 2, Section 150.13 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS); and Part 4, Section 310 Clinical Trials.
  • CMS Publication 100-04, Medicare Benefit Policy Manual, Chapter 23- Fee Schedule Administration and Coding Requirements, Section 30 Services paid under the Medicare Physicians Fee Schedule.
  • CMS Publication 100-04 Claims Processing Manual, Chapter 32, Section 68 Investigational Device Exemptions (IDE) Studies, and Section 330 Percutaneous Image-guided Lumbar Decompression (PILD) for Lumbar Spinal Stenosis (LSS).
  • CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Sect.13.5.4 Reasonable and necessary provisions in LCDs & 13.5.3 Evidentiary Content
  • CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.2.4- Proposed LCD.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The American Medical Association (AMA) develops temporary Current Procedural Terminology (CPT) Category III codes to track the utilization of emerging technologies, services, and procedures. The CATEGORY III CPT Code description does not establish a service or procedure as safe, effective or applicable to the clinical practice of medicine.

Indications and Limitations:
Section 1862(a)(1)(A) of the Social Security Act (SSA) is the statutory basis for denying payment for types of care, items, services, and procedures, not excluded by any other statutory clause while meeting all technical requirements for coverage, that are determined to be any of the following:

  1. Not generally accepted by the medical community as safe and effective in the setting and for the condition for which it is used;
  2. Not proven safe and effective based on peer review or scientific literature;
  3. Experimental;
  4. Not medically necessary for a particular patient;
  5. Furnished at a level, duration, or frequency that is not medically appropriate;
  6. Not furnished in accordance with accepted standards of medical practice; or
  7. Not furnished in a setting appropriate to the patient’s medical needs and condition.

Items and services must be established as safe and effective to be considered medically necessary. That is, the items and services must be:

  1. Consistent with the symptoms of diagnosis of the illness or injury under treatment; and
  2. Necessary for, and consistent with, generally accepted professional medical standards of care (e.g., not experimental) and;
  3. Not furnished primarily for the convenience of the patient, the provider or supplier; and
  4. Furnished at the most appropriate level of care that can be provided safely and effectively to the patient.

Medical devices that are not approved for marketing by the Food and Drug Administration (FDA) are considered investigational and are not considered reasonable and necessary under SSA 1862(a)(1)(A). Medicare payment, therefore, may not be made for procedures performed using devices that have not been approved for marketing by the FDA unless performed within the context of a clinical trial qualifying under the National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) or in approved FDA Investigational Device Exemption (IDE) trial.

A/B MACs (B) continue to determine if a service is reasonable and necessary to treat illness or injury. If a service is not reasonable and necessary to treat illness or injury for any reason (including lack of safety and efficacy because it is an experimental procedure, etc.), A/B MACs (B) consider the service noncovered notwithstanding the presence of a payment amount for the service in the Medicare fee schedule.

FDA designation/ determination of a device as 510(k) mean(s) that the device has been approved for marketing by the FDA because it is similar to something already on the market that was "grandfathered in" by the FDA and therefore these devices are eligible for coverage.

In addition, items, services, or devices may also be not covered under SSA 1862 (a) (1) (D), (E), or (O).

Summary of Evidence

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:

  1. Intracranial internal carotid artery (ICA) OR middle cerebral artery (MCA) occlusion
  2. 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)
  3. 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

0525T-0532T
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.

0398T

MRgFUS unilateral thalamotomy is considered medically reasonable and necessary in patient with one of the following:

  1. Essential Tremor (ET)- defined as refractory to at least two trials of medical therapy, including at least one first-line agent
  2. Tremor-Dominant Parkinson’s disease (TDPD) (and both a & b)
    1. refractory (or intolerant) to levodopa or levodopa equivalent daily dosage (LEDD) ≥ 900 mg
    2. 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:

  1. Treatment of head or voice tremor
  2. Bilateral thalamotomy
  3. Following conditions:
    1. A neurodegenerative condition other than Parkinson’s disease
    2. Unstable cardiac disease
    3. Untreated coagulopathy
    4. Risk factors for deep-vein thrombosis
    5. Severe depression, i.e., a score greater than or equal to 20 on the Patient Health Questionnaire 9 (PHQ-9)
    6. Cognitive impairment defined by a score of less than 24 on the Mini-Mental Status Examination
    7. Previous brain procedure (transcranial magnetic stimulation, deep brain stimulation, stereotactic lesioning, or electroconvulsive therapy)
    8. A skull density ratio (the ratio of cortical to cancellous bone) of <0.45 ± 0.05 as calculated from the screening CT.
    9. MRI contraindication
    10. Drug-induced Parkinsonism
    11. History of seizures, brain tumor, intracranial aneurysm or arteriovenous malformation requiring treatment
    12. 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.

Analysis of Evidence (Rationale for Determination)

Level of Evidence for 0042T
The 2019 update to the 2018 American Heart Association (AHA)/American Stroke Association (ASA) guidelines 29 for the early management of patients with AIS state “In selected patients with AIS within 6 to 24 hours of last known normal who have large vessel occlusion (LVO) in the anterior circulation, obtaining CTP, DW-MRI, or MRI perfusion is recommended to aid in patient selection for mechanical thrombectomy, but only when imaging and other eligibility criteria from RCTs showing benefit are being strictly applied in selecting patients for mechanical thrombectomy”. (Class of recommendation I-strong; level (quality) of evidence A) 30. Since only the DAWN and DEFUSE 3 RCTs show a benefit of late-period EVT, they further warn: “DAWN or DEFUSE 3 eligibility should be strictly adhered to in clinical practice.” These guidelines do not recommend CTP to determine eligibility for either thrombolytic therapy or EVT in the early (<6 hours) period (Class of recommendation I-strong; level (quality) of evidence B-Nonrandomized), or for any other indication (e.g., prediction of hemorrhagic transformation in acute ischemic injury). Other guidelines have similar recommendations 31-33.
The guidelines also caution that advanced, multimodal pretreatment imaging should not delay administration of IV tPA referencing “failed to demonstrate clinical efficacy in patients with various pretreatment imaging biomarkers compared with those without those markers” (Class of recommendation-III: Strong for Harm; level of evidence; quality of evidence B-NR).

National Institute for Health and Care Excellence recommends: “If thrombectomy might be indicated, perform imaging with CT contrast angiography following initial non-enhanced CT. Add CT perfusion imaging (or MR equivalent) if thrombectomy might be indicated beyond 6 hours of symptom onset.” They also recommend thrombectomy with intravenous thrombolysis for occlusion of the proximal posterior circulation on CTA or MRA if CTP of DWI shows limited infarct core volume with the potential to salvage brain tissue 34. However, there is minimal evidence regarding the appropriate threshold and utility of CTP in the posterior circulation, and accurate calculations are limited in posterior fossa by skull base and orbit artifact 14. There is evidence DWI has an advantage over CTP for posterior fossa stokes, lacunar infarcts, and small watershed infarcts 14.

ECRI Clinical Evidence Assessment on Perfusion CTP reviewed the literature on CTP as an alternative imaging evaluation in addition to NCCT and determined the evidence was “inconclusive” due to mixed results. They report “CTP’s clinical utility compared with that of NCCT and magnetic resonance imaging (MRI) for assessing AIS has not been established because of too few data. No studies compared CTP clinical utility with other imaging methods. The RCT focused on treatment and did not randomly assign imaging methods, which created a risk of selection bias when comparing CTP to perfusion MRI. Most studies assessed in the SRs, as well as the diagnostic accuracy studies published after the SRs, were at high risk of bias due to retrospective design and single-center focus 21.

We consider the concordant level I evidence of a large clinical benefit after CTP imaging (using automated post-processing software algorithmic analysis) in AIS secondary to LVO, to assist in late EVT eligibility determination per AHA/ASA guidelines, medically reasonable and necessary. While there is a promise to CTP technology applied to other neuroimaging areas, there is still insufficient evidence. Other stroke or non-stroke indications, including routine assessment of AIS, determination of HT, and other indications, are not considered medically reasonable and necessary at this time.

Level of Evidence for 0525T-0532T
Evaluation of the evidence: The issue is whether to provide coverage of the service represented by CPT® 0525T-0532T. The 681 pages of material submitted is largely irrelevant to the issue. The articles that touch on the issue are marred by a weak methodology or at least a weak description of the methodology. (Pease see “Summary of the Evidence.”) Coverage will be denied as not reasonable and medically necessary.

Level of Evidence for 0398T
Quality -Moderate
Strength - Moderate
Weight – Moderate

While more trials would be helpful, the evidence submitted in the reconsideration request does indicate that this may have a role in avoiding more invasive interventions. The evidence submitted also allows the establishment of indications for coverage and exclusions from coverage.

However, given the support for traditional thalamotomy, generally, as an alternative “if DBS is not available or practical”, and the support for MRgFUS thalamotomy, specifically, as an alternative in patients “who are not a candidate for DBS” by the American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS) and the American Association of Stereotactic and Functional Neurosurgery (ASSFN)8, WPS GHA considers MRgFUS reasonable and necessary in that context.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information
  1. The patient's medical record must contain documentation that fully supports the medical necessity for services or procedures described by Category III CPT Codes as they are covered by Medicare. (See section entitled “Coverage Indications, Limitations, and/or Medical Necessity”). This documentation includes, but is not limited to, relevant medical history, physical examination, results of pertinent diagnostic tests or procedures, and any other records that describe or support the evaluation and treatment of the patient.

  2. All claims containing any Category III code referenced in this LCD may be subject to review and denial if documentation is incomplete and does not support reasonable and necessary indications.

Utilization Guidelines

Coverage Determinations according to IOM 100-04 Medicare Program Integrity Manual prior to 01/08/2019.

Category III Codes discussed in this policy may be listed in separate WPS LCD and Billing and Coding Articles. For services addressed in a separate LCD and Billing and Coding Article, all criteria addressed in that LCD and Billing and Coding Article must be met.

CPT Codes 0501T-0504T: coverage in L35490 no longer applicable. Please refer to L38839 Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease
and A58473 Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease for Coverage Indications, Limitations, and/or Medical Necessity. Effective 04/25/2021.

0075T, 0076T Refer to CMS publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1 – Coverage Determinations, Part 1, § 20.7 – Percutaneous Transluminal Angioplasty (PTA). Billing instructions are listed in the CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 32 – Billing Requirements for Special Services, Sections 160-160.3 – PTA for Implanting the Carotid Stent. As directed in The CPT 2018 Professional code book, use 0076T in conjunction with 0075T.

0184T The National Comprehensive Cancer Network (NCCN) guideline on treatment of rectal cancer states that, when criteria for transanal resection are met, transanal endoscopic microsurgery (TEMS) can be used when the tumor can be adequately identified in the rectum. It further states that TEMS for more proximal lesions (greater than 8 cm from anal verge) may be technically feasible.

0253T, 0474T An anterior segment aqueous drainage device, utilizing the internal approach, for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma on medication.

0275T This is a procedure proposed as a treatment for symptomatic Lumbar Spinal Stenosis (LSS) unresponsive to conservative therapy. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously remove a portion of the lamina and debulk the ligamentum flavum. The procedure is performed under x-ray guidance (e.g., fluoroscopic, CT) with the assistance of contrast media to identify and monitor the compressed area via epiduragram. Effective for claims with dates of service on or after January 9, 2014, Percutaneous Image-Guided Lumbar Decompression (PILD) is covered by Medicare when provided in a clinical study under section 1862(a)(1)(E) through Coverage with Evidence Development (CED) for beneficiaries with LSS who are enrolled in an approved clinical study and meets the criteria listed in NCD-150.13, Transmittal 167. Effective for claims with dates of service on or after December 7, 2016, Medicare will cover PILD under CED for beneficiaries with LSS who are enrolled in a CMS-approved prospective longitudinal study PILD procedure using and FDA-approved/cleared device that completed a CMS-approved RCT (randomized controlled trial) that met the criteria listed in the January 2014 NCD (see CR 8757, transmittal #2959, dated May 16, 2014). This is an expansion of coverage for PILD under CED, therefore the current coding and editing instructions remain unchanged.

0308T Effective July 1, 2012 CPT/ HCPCS code 0308T (insertion of ocular telescope prosthesis including removal of crystalline lens) is payable. Further, claims submitted by Part A providers and ambulatory surgical centers for device pass-through category C1840 must be billed with HCPCS code 0308T (insertion of ocular telescope prosthesis including removal of crystalline lens) to receive pass-through payment.

0394T, 0395T High dose electronic brachytherapy for skin surface application and for interstitial or intracavitary treatment, respectively. Was code 0182T prior to 01/01/2016. It is reimbursable with documentation of medical necessity.

0449T, 0450T Insertion of an aqueous drainage device is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

Sources of Information

This bibliography presents those sources that were obtained during the development of this policy:
Current Procedural Terminology (CPT®), Professional Edition (2019) American Medical Association.
Other MAC contractors policies

Bibliography

0042T

  1. Lopez, A.D., et al., Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. 2006. 367(9524): p. 1747-1757.
  2. Albers, G.W., et al., A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3). 2017, SAGE Publications Sage UK: London, England.
  3. Albers, G.W., et al., Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med, 2018. 378(8): p. 708-718.
  4. Lee, M., K.-S. Hong, and J.L.J.S. Saver, Efficacy of intra-arterial fibrinolysis for acute ischemic stroke: meta-analysis of randomized controlled trials. 2010. 41(5): p. 932-937.
  5. Marks, M.P., et al., Angiographic outcome of endovascular stroke therapy correlated with MR findings, infarct growth, and clinical outcome in the DEFUSE 2 trial. 2014. 9(7): p. 860-865.
  6. Yoo, A.J., et al., Refining angiographic biomarkers of revascularization: improving outcome prediction after intra-arterial therapy. 2013. 44(9): p. 2509-2512.
  7. Broderick, J.P., et al., Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. 2013. 368(10): p. 893-903.
  8. Nogueira, R.G., et al., Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med, 2018. 378(1): p. 11-21.
  9. Vagal, A., et al., Increasing use of computed tomographic perfusion and computed tomographic angiograms in acute ischemic stroke from 2006 to 2010. 2014. 45(4): p. 1029-1034.
  10. Vagal, A., et al., Automated CT perfusion imaging for acute ischemic stroke: Pearls and pitfalls for real-world use. Neurology, 2019. 93(20): p. 888-898.
  11. Adebayo, O.D. and G.J.E.s.j. Culpan, Diagnostic accuracy of computed tomography perfusion in the prediction of haemorrhagic transformation and patient outcome in acute ischaemic stroke: A systematic review and meta-analysis. 2020. 5(1): p. 4-16.
  12. Parsons, M.W., et al., Perfusion computed tomography: prediction of final infarct extent and stroke outcome. Ann Neurol, 2005. 58(5): p. 672-9.
  13. Campbell, B.C., et al., Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med, 2015. 372(11): p. 1009-18.
  14. Vagal, A., et al., Automated CT perfusion imaging for acute ischemic stroke: Pearls and pitfalls for real-world use. J Neurology, 2019. 93(20): p. 888-898.
  15. Albers, G.W., Use of Imaging to Select Patients for Late Window Endovascular Therapy. Stroke, 2018. 49(9): p. 2256-2260.
  16. Bivard, A. and M. Parsons, Tissue is more important than time: insights into acute ischemic stroke from modern brain imaging. Curr Opin Neurol, 2018. 31(1): p. 23-27.
  17. Allmendinger, A.M., et al., Imaging of stroke: Part 1, perfusion ct??? Overview of imaging technique, interpretation pearls, and common pitfalls. 2012. 198(1): p. 52-62.
  18. Shen, J., et al., Comparative accuracy of CT perfusion in diagnosing acute ischemic stroke: A systematic review of 27 trials. PLoS One., 2017. 12(5).
  19. Zhang, X.-H. and H.-M.J.M. Liang, Systematic review with network meta-analysis: Diagnostic values of ultrasonography, computed tomography, and magnetic resonance imaging in patients with ischemic stroke. 2019. 98(30).
  20. Rudkin, S., et al., Imaging of acute ischemic stroke. Emergency radiology
    2018. 25(6): p. 659-672.
  21. ECRI, Perfusion Computed Tomography with Contrast for Evaluating Stroke. 2020: ECRI Clinical Evidence Assessment.
  22. Kim, J.H., et al., Comparative evaluation of cerebral blood volume and cerebral blood flow in acute ischemic stroke by using perfusion-weighted MR imaging and SPECT. Acta Radiol, 2002. 43(4): p. 365-70.
  23. Horsch, A.D., et al., Computed tomography perfusion derived blood-brain barrier permeability does not yet improve prediction of hemorrhagic transformation. Cerebrovasc Dis., 2018. 45(1-2): p. 26-32.
  24. Sarraj, A., et al., Outcomes of Thrombectomy in Transferred Patients With Ischemic Stroke in the Late Window: A Subanalysis From the DEFUSE 3 Trial. JAMA Neurol, 2019. 76(6): p. 682-689.
  25. Sarraj, A., et al., Optimizing Patient Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT): A Prospective, Multicenter Cohort Study of Imaging Selection. Ann Neurol, 2020. 87(3): p. 419-433.
  26. Siegler, J.E., et al., Mismatch between automated CTP and ASPECTS score in patients with anterior large vessel occlusion. Clin Neurol Neurosurg, 2020. 194: p. 105797.
  27. Albers, G.W., et al., Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. J New England Journal of Medicine, 2018. 378(8): p. 708-718.
  28. Kauw, F., et al., Computed Tomography Perfusion Data for Acute Ischemic Stroke Evaluation Using Rapid Software: Pitfalls of Automated Postprocessing. J Comput Assist Tomogr., 2020. 44(1): p. 75-77.
  29. Powers, W.J., et al., Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. J Stroke, 2019. 50(12): p. e344-e418.
  30. Powers, W.J., et al., Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke, 2019. 50(12): p. e344-e418.
  31. Sacks, D., et al., Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke: From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO). J Vasc Interv Radiol, 2018. 29(4): p. 441-453.
  32. Dorn, F., et al., Brain perfusion CT for acute stroke using a 256-slice CT: improvement of diagnostic information by large volume coverage. European radiology, 2011. 21(9): p. 1803-10.
  33. Gruner, J.M., et al., Brain perfusion CT compared with15O-H2O-PET in healthy subjects. EJNMMI research, 2011. 1(1): p. 28.
  34. NICE. Stroke and transient ischaemic attack in over 16s: diagnosis and initial management. 2019.

0525T-0532T

  1. Sheifer SE, Manolio T a., Gersh BJ. Unrecognized Myocardial Infarction. Ann Intern Med. 2001;(135)801-811.
  2. Kwong RY, Chan AK, Brown KA, et al. Impact of Unrecognized Myocardial Scar Detected by Cardiac Magnetic Resonance Imaging on Event-Free Survival in Patients Presenting With Signs or Symptoms of Coronary Artery Disease. Circulation. 2006;113(23):2733-2743.
  3. Mirzaei S, Steffen A, Vuckovic K, et al. The Association Between Symptom Onset
    Characteristics and Prehospital Delay in Women and Men with Acute Coronary Syndrome. Eur J Cardiovasc Nurs. 2019.
  4. DeVon HA, Hogan N, Ochs AL, Shapiro M. Time to Treatment for Acute Coronary
    Syndromes: The Cost of Indecision. J Cardiovasc Nurs. 2010;25(2):106-114.
  5. Moser DK, Kimble LP, Alberts MJ, et al. Reducing Delay in Seeking Treatment by Patients with Acute Coronary Syndrome and Stroke: A Scientific Statement from the American Heart Association Council on Cardiovascular Nursing and Stroke Council. Circulation. 2006;114(2):168-182.
  6. Flynn A, Moscucci M, Share D, et al. Trends in Door-to-Balloon Time and Mortality in Patients with ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. Arch Intern Med. 2010;170(20):1842-1849.
  7. Wasson LT, Shaffer J, Alcántara C, et al. The Association of Post-traumatic Stress Disorder and Quality of Life During the First Year After Acute Coronary Syndrome. Int J Cardiol. 2014;176(3):1042-1043.
  8. Sánchez M, López B, Bragulat E, et al. Predictors and Outcomes of Frequent Chest Pain Unit Users. Am J Emerg Med. 2009;27(6):660-667.

0398T

  1. Chang, J.W., et al. (2017). A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: results at the 2-year follow-up. American Neurological Association, 83,107-114.
  2. Elias, W.J., et al. (2016). A randomized trial of focused ultrasound thalamotomy for essential tremor. N Engl J Med, 375, 730-9.
  3. Bond AE, Shah BB, Huss DS, et al. Safety and efficacy of focused ultrasound thalamotomy for patients with medication-refractory, tremor-dominant Parkinson disease: a randomized clinical trial. JAMA neurology. 2017;74(12):1412-1418.
  4. Food and Drug Administration. Exablate Model 4000 Types 1.0 and 1.1 System Summary of Safety and Effectiveness Data. December 16, 2018. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdf Accessed 12/21/2021.
  5. Schlesinger I, Eran A, Sinai A, et al. MRI guided focused ultrasound thalamotomy for moderate-to-severe tremor in Parkinson’s disease. Parkinson’s disease. 2015;2015.
  6. Zaaroor M, Sinai A, Goldsher D, Eran A, Nassar M, Schlesinger I. Magnetic resonance–guided focused ultrasound thalamotomy for tremor: a report of 30 Parkinson's disease and essential tremor cases. Journal of neurosurgery 2017;128(1):202-210.
  7. Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AMJN. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. 2017;89(8):771-775.
  8. Neurosurgery ASfSaF. ASSFN Position Statement on MR-guided Focused Ultrasound for the Management of Essential Tremor. https://www.assfn.org/Guidelines/assfn-position-statement-on-mr-guided-focused-ultrasound-for-the-management-of-essential-tremor/. Accessed 12/22/2021.
  9. Lin F, Wu D, Yu J, Weng H, Chen L, et al. Comparison of efficacy of deep brain stimulation and focused ultrasound in parkinsonian tremor: A systematic review and network meta-analysis. J Neurol Neurosurg Psychiatry 2021;92:434-443

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
04/27/2023 R31

Posted 04/27/2023-Removed all reference to CPT code 0254T from LCD as this code was deleted 01/01/2020. References to CPT codes 0501T-0504T removed from Summary of Evidence, Analysis of Evidence, and Bibliography. Moved direction for CPT Codes 0501T-0504T: coverage to be found in L38839 Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease and A58473 Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease for Coverage Indications, Limitations, and/or Medical Necessity under Utilization Guidelines.

  • Other ((Correction))
06/12/2022 R30

Posted 06/30/2022-Under Summary of Evidence 0501T-0504T removed broken hyperlink and changed article citation to reflect AMA formatting.

  • Other
06/12/2022 R29

Posted 04/28/2022. Under 0398T added coverage indications, exclusions from coverage and studies to support Tremor Dominant Parkinson’s Disease. Added additional information for MRgFUS thalamotomy under Analysis of Evidence. Additional references were added under Bibliography section 0398T. Under CMS National Coverage Policy change requests and references were deleted and under Social Security Acts added “Title XVIII of the Social Security Act” was added to the beginning of the sentence on the last two bullet points.

  • Other
01/01/2022 R28

02/01/2022 - Posted 02/10/2022 Under Summary of Evidence 0501T-0504T in paragraph 5 corrected hyperlink.

  • Typographical Error
01/01/2022 R27

12/30/2021 Annual CPT/HCPCS Under Utilization Guidelines deleted codes 0191T, 0376T and 0548T thru 0551T and all information related to these codes. Under Summary of Evidence, Analysis of Evidence and Bibliography removed all information related to deleted code 0355T.

  • Other (Annual CPT/HCPCS Code updates)
04/25/2021 R26

03/11/2021 Updated CPT Codes 0501T-0504T: coverage in L35490 no longer applicable. Please refer to L38839 Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease and A58473 Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease for Coverage Indications, Limitations, and/or Medical Necessity. Effective 04/25/2021.

  • Provider Education/Guidance
03/28/2021 R25

02/11/2021 Updated CPT Code 0355T: Denial of coverage is no longer applicable. Please refer to L38837 Colon Capsule Endoscopy (CCE) and A58471 Billing and Coding: Colon Capsule Endoscopy (CCE) for Coverage Indications, Limitations, and/or Medical Necessity. Effective 03/28/2021. 2021 CPT/HCPCS Annual code update: 0295T, 0296T, 0297T, and 0298T deleted. Effective 01/01/2021 and removed reference to LCD L34636 Electrocardiographic (EKG or ECG) Monitoring (Holter or Real-Time Monitoring) and A57476 Billing and Coding: Electrocardiographic (EKG or ECG) Monitoring (Holter or Real-Time Monitoring).

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
10/29/2020 R24

10/29/2020: Reformatted CMS National Coverage Policy. Coverage Indications, Limitations and/or Medical Necessity updated: removed sentence #1 and #2 referencing Category III codes and removed last paragraph related to reconsideration process. Relocated medical necessity from utilization guidelines to Summary of Evidence for CPT codes 0042T, 0398T, and 0501T-0504T. Utilization Guideline statement updated and reformatted. Utilization Guidelines: updated 0548T-0051T: relocated billing and coding guidance of CPT code 0551T to A56902 and Change Request 11293 reference added.

  • Provider Education/Guidance
07/01/2020 R23

06/25/2020: CMS National Coverage Policy added: CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.2.4- Proposed LCD. Summary of Evidence added: 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; CPT code 0042T with Summary of Evidence and Analysis of Evidence; CPT code range 0525T-0532T with Summary of Evidence and Analysis of Evidence. Level of Evidence for 0254T added Effective 01/01/2020 Category I code available. Please refer to the current CPT codebook.
Utilization Guidelines added: Coverage Determinations according to IOM 100-04 Medicare Program Integrity Manual, prior to Change Request 10901, are listed below; Category III Codes discussed in this policy may be listed in separate WPS Medicare LCD and Billing and Coding Articles; For services addressed in a separate LCD and Billing and Coding Article, all criteria addressed in that LCD and Billing and Coding Article must be met. Reformatted: 0295T-0298T to include L34636 “Electrocardiographic (EKG or ECG) Monitoring (Holter or Real-Time Monitoring)” and A57476 Billing and Coding: Electrocardiographic (EKG or ECG) Monitoring (Holter or Real-Time Monitoring). Bibliography included for CPT code 0042T and CPT code range 0525T-0532T.

  • Provider Education/Guidance
02/09/2020 R22

12/26/2019 Content updated related to reconsideration request for CPT codes 0254T and 0355T. Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included. Coverage is denied at this time for 0254T and 0355T. CPT/HCPCS annual update: deleted CPT 0254T. (Effective 01/01/2020) Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries.

  • Reconsideration Request
  • Other ((Reconsideration Request for CPT codes 0254T, 0355T))
01/01/2020 R21

12/19/2019 CPT/HCPCS annual code update: deleted CPT 0249T (true code available) from Utilization Guidelines in LCD and associated A56902 Billing and Coding: Category III Codes. Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries.

  • Revisions Due To CPT/HCPCS Code Changes
11/01/2019 R20

Content has been moved to the new template.

  • Revisions Due To Code Removal
08/29/2019 R19

08/29/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS and ICD-10 codes have been removed from this LCD and placed in Billing and Coding: Category III Codes linked to this LCD. Consistent with Change Request 10901 language from IOMs and/or regulations has been removed and the applicable manual/regulation has been referenced. There will not be a lapse in coverage and there has been no change to the coverage content of this LCD. Review completed 08/05/2019.

  • Other (Changes in response to CMS Change Request 10901, review completed)
07/01/2019 R18

08/01/2019 Information from the Utilization Guidelines has been reformatted/relocated. CPT/HCPCS codes: Created Group 5 Paragraph and Group 5 Table to include CPT codes 0548T, 0549T, 0550T and 0551T. Removed duplicative language about CPT code C9746. Corrected minor typographical error. No change to content or coverage effective date.

  • Provider Education/Guidance
07/01/2019 R17

06/27/2019 Added the statement to the Utilization Guidelines for 0548T - 0551T: Implantation of a transperineal periurethral balloon continence device is indicated for the treatment of adult men who have stress urinary incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy. Documentation must support that the patient has had a prostatectomy or transurethral resection of the prostate more than 12 months prior to placement of the device(s). CPT codes 0551T is only separately payable outside of the global period for 0548T and 0549T.Coverage will only be allowed when the service is delivered in clinical situations meeting medical necessity.
HCPCS code C9746 (Transperineal implantation of permanent adjustable balloon continence device, with cystourethroscopy, when performed and/or fluoroscopy, when performed), which was effective July 1, 2017, was deleted June 30, 2019.
C9746 has been replaced with CPT code 0548T and 0549T effective July 1, 2019. CPT Codes 0548T, 0459T, 0450T and 0551T and descriptions added.
Refer to Change Request (CR) 11293: Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2019 Update and Change Request (CR) 11328: July 2019 Update of the Ambulatory Surgical Center (ASC) Payment System.
Created Group 6 ICD-10 code table to include the following ICD-10 codes for CPT codes 0458T-0451T: N39.3, N39.42, N39.43, N39.44, N39.45, N39.46, N39.490, N39.491, N39.492 and N39.498. Please refer to Utilization Guidelines for additional information.
Coverage effective 7/1/2019.

  • Revisions Due To CPT/HCPCS Code Changes
01/01/2019 R16

01/01/2019 Annual review completed 11/30/2018. CPT/HCPCS Code Updates: deleted Group 3 Paragraph and corresponding Group 3 table of CPT/HCPCS codes 0387T, 0389T, 0390T and 0391T. (These leadless pacemaker codes now have true codes. See NCD 20.8.4.) Removed corresponding Group 3 Paragraph and Group 3 ICD-10 code Z00.6. Renumbered subsequent Paragraphs and Groups of codes. Removed the Utilization Guidelines language for 0387T, 0389T, 0390T, and 0391T For Part B only. Please see NCD for Leadless Pacemakers (20.8.4) for claims processing instructions (see CR 10117, Transmittal #3815, dated 07/28/2017). Removed the related National Coverage Documents: 20.8.4 – Leadless Pacemakers.

  • Revisions Due To CPT/HCPCS Code Changes
  • Other (Annual Review)
09/01/2018 R15

09/01/2018  Removed language in the Utilization Guidelines for 0075T-0076T to refer to NCD 20.7 Percutaneous Transluminal Angioplasty. Updated IOM references.

  • Other
07/01/2018 R14

07/01/2018 Added code 0398T to Group 5 table of CPT codes; added G25.0 to the corresponding Group 6 table of ICD-10 codes. Added information to the Summary of Evidence and Analysis of Evidence sections; added a statement to the Utilization Guidelines including Criteria for Medical Necessity and Exclusions from Coverage; and added resources to the Bibliography section.

  • Revisions Due To CPT/HCPCS Code Changes
  • Reconsideration Request
06/01/2018 R13

06/01/2018 Added codes 0501T, 0502T, 0503T and 0504T FFRct to Group 4 table of codes. Added the statement to the Utilization Guidelines: 0501T - 0504T 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. Added the corresponding Group 5 diagnosis codes: C38.0, C45.2, C79.89, C79.9, D15.1, I20.0, I20.1, I20.8, I24.0, I25.10, I25.110, I25.111, I25.118, I25.119, I25.2, I25.3, I25.41, I25.42, I25.5, I25.6, I25.700, I25.701, I25.708, I25.709, I25.710, I25.711, I25.718 I25.719, I25.720, I25.721, I25.728, I25.729, I25.730, I25.731, I25.738, I25.739, I25.750, I25.751, I25.758, I25.759, I25.760, I25.761, I25.768, I25.769, I25.790, I25.791, I25.798, I25.799, I25.810, I25.811, I25.812, I25.89, I25.9, I27.0, I31.0, I31.1, I31.2, I31.3, I31.4, I31.8, I31.9, I34.0, I34.1, I34.2, I34.8, I34.9, I35.0, I35.1, I35.2, I35.8, I35.9, I42.0, I42.5, I42.8, I42.9, I48.0, I48.1, I48.2, I48.3, I48.4, I48.91, I48.92, I49.01, I49.02, I50.20, I50.21, I50.22, I50.23, I50.30, I50.31, I50.32, I50.33, I50.40, I50.41, I50.42, I50.43, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89, I50.9, I71.01, I71.1, I71.2, Q20.1, Q20.2, Q20.3, Q20.4, Q20.5, Q20.6, Q20.8, Q20.9, Q21.0, Q21.1, Q21.2, Q21.3, Q21.4, Q21.8, Q21.9, Q22.0, Q22.1, Q22.2, Q22.3, Q22.4, Q22.5, Q22.6, Q22.8, Q22.9, Q23.0, Q23.1, Q23.2, Q23.3, Q23.4, Q23.8, Q23.9, Q24.0, Q24.1, Q24.2, Q24.3, Q24.4, Q24.5, Q24.8, Q24.9, Q25.0, Q25.1, Q25.21, Q25.29, Q25.3, Q25.40, Q25.41, Q25.42, Q25.43, Q25.44, Q25.45, Q25.46, Q25.47, Q25.48, Q25.49, Q25.5, Q25.6, Q25.71, Q25.72, Q25.79, Q25.8, Q25.9, Q26.0, Q26.1, Q26.2, Q26.3, Q26.4, Q26.8, Q26.9, R06.02, R06.03, R07.2, R07.82, R07.89, R07.9, R94.30, R94.39. For 0501T-0504T: added resources to the Bibliography section and added information to the Summary of Evidence section and Analysis of Coverage section.

  • Reconsideration Request
01/01/2018 R12

 

01/01/2018 Annual review done 12/01/2017, no change in coverage. Typographical corrections made. CPT/HCPCS code updates: description change to code 0474T.

  • Revisions Due To CPT/HCPCS Code Changes
  • Other (Annual Review)
12/01/2017 R11

 

12/01/2017 Added the phrase “for Part B only” to the Group 3 Paragraph of CPT/HCPCS codes, to the Group 3 Paragraph of diagnosis codes, and to the Utilization Guidelines for codes 0387T, 0389T, 0390T, and 0391T.

 

  • Other
11/01/2017 R10

11/01/2017 Added codes 0449T and 0450T to Group 1 and created a Group 4 list of diagnosis codes for 0449T and 0450T: H40.10X3, H40.10X4, H40.1113, H40.1114, H40.1123, H40.1124, H40.1133, H40.1134, H40.1313, H40.1314, H40.1323, H40.1324, H40.1333, H40.1334, H40.1413, H40.1414, H40.1423, H40.1424, H40.1433, and H40.1434. Added the following information under Utilization Guidelines for the use of 0449T and 0450T: Insertion of an aqueous drainage device is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open-angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. Added code 0253T to Group 1, to Group 1 Paragraph, and under Utilization Guidelines for an anterior segment aqueous drainage device.

  • Revisions Due To ICD-10-CM Code Changes
  • Reconsideration Request
10/01/2017 R9

10/01/2017 ICD-10 code updates: to Group 2 deleted code M48.06 and added codes M48.061 and M48.062. Added code 0474T to Group 1 of covered CPT/HCPCS codes and to Group 1 Paragraph. Updated CMS National coverage information. Added language to Paragraph 2 to clarify claims processing for NCD 150.13 Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD for LSS) for code 0275T.  At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
  • Reconsideration Request
09/01/2017 R8

09/01/2017 Added Group 3 Paragraph for coverage of Leadless Pacemakers, added Group 3 CPT codes 0387T, 0389T, 0390T and 0391T, and added Group 3 diagnosis code Z00.6 per NCD 20.8.4 effective 01/18/2017. At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other
01/01/2017 R7 01/01/2017 Annual review done 12/02/2016. Formatting changes made. Annual CPT/HCPCS code changes: description change to code 0275T; removed deleted codes 0171T, 0172T, and 0281T.
  • Revisions Due To CPT/HCPCS Code Changes
  • Other (Annual Review)
11/01/2016 R6 11/01/2016 Added language to Paragraph 3 to clarify claims processing for NCD 150.13 Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD for LSS) for code 0275T. Effective 10/01/2015.
  • Other
10/01/2016 R5 10/01/2016 Per ICD-10 Code Updates: In Group 1: deleted codes H40.11X1 and H40.11X2 and added codes H40.1111, H40.1112, H40.1121, H40.1122, H40.1131, and H40.1132, effective 10/01/2016.
  • Revisions Due To ICD-10-CM Code Changes
05/01/2016 R4 05/01/2016 Added 0249T to Group 1 codes effective 05/01/2016. Added 0281T to Group 4 codes effective 02/08/2016.
  • Reconsideration Request
  • Other
01/01/2016 R3 01/01/2016 Annual review done 12/02/2015. Annual CPT/HCPCS code changes: deleted codes 0099T and 0182T; added codes 0394T and 0395T which replaced 0182T. Removed CAC information.
  • Revisions Due To CPT/HCPCS Code Changes
11/01/2015 R2 11/01/2015 Added codes H40.11X1 and H40.11X2 to Group 1 Chart, to be effective 10/01/2015. Formatting changes made.
  • Other (Diagnosis Code Update)
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 02/01/2015: CPT Code 0376T added to the policy as an add-on code to be used in conjunction with CPT Code 0191T.
  • Revisions Due To CPT/HCPCS Code Changes
  • Other
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