LCD Reference Article Response To Comments Article

Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

A58520

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Source Article ID
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Article ID
A58520
Original ICD-9 Article ID
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Article Title
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)
Article Type
Response to Comments
Original Effective Date
12/13/2020
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As an important part of Medicare Local Coverage Determination (LCD) development, Noridian Healthcare Solutions solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Computed Tomography Cerebral Perfusion Analysis. The official notice period for the final LCD begins on October 29, 2020 and the final determination will become effective for services rendered on or after December 13, 2020.

 

References:

  1. Saposnik G, Strbian D. Enlightenment and Challenges Offered by DAWN Trial (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo). Stroke. 2018 Feb;49(2):498-500.
  2. Albers GW, Marks MP, Kemp S, et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718.

 

Response To Comments

Number Comment Response
1

There were several comments recommending that coverage be allowed in the 0-24 hour period after presenting.

The policy allows treatment within 6-16 hours if using DEFUSE 3 criteria and 6-24 hours if using DAWN criteria (Albers 2018, Saposnik 2018). The AHA/ASA guidance states DAWN and DEFUSE 3 eligibility should be strictly adhered to in clinical practice. As the AHA/ASA cautions against use outside of the study protocols, therefore, we will restrict coverage to those protocols until additional literature supports expansion.

2

There were several comments requesting the removal of the word “small” from the description.

Noridian is in agreement with deleting the word small as the DAWN and DEFUSE3 trials each had patients with larger volume strokes (Albers 2018, Saposnik 2018).

3

More than one comment requested the removal of acute ischemic stroke (AIS) caused by unilateral large vessel occlusion (LVO) in the proximal circulation limitation.

Coverage is based strictly on the DAWN and DEFUSE 3 criteria (Albers 2018, Saposnik 2018). Imaging may not be accurate outside of the proximal circulation. There may be promise in the future for EVT for anterior cerebral and posterior circulation, but at this point is not established.

4

There were a couple of comments requesting the addition of more ICD-10 codes.

Current coverage criteria are for use after stroke is established so should be able to code with specific stroke code. The coverage is for determining if patient is a candidate for EVT and needs to have established stroke to consider.

5

One comment recommends the use of CTP in any patient suspected of having an AIS

The current literature does not support the use of CTP as part of evaluation or screening stoke protocols. The existing evidence support the use of CTP to aid in selection for EVT. To be considered a candidate for EVT the patient must already have a known stoke and meet the criteria of the DAWN or DEFFUSE 3 trail where clinical benefit has been demonstrated (Albers 2018, Saposnik 2018). If future literature addresses the use of CTP as part of a screening or evaluation protocol this can be submitted as part of the LCD reconsideration process.

6

There was one comment addressing the limited availability of MRI perfusion in the acute phase of stroke assessment where CTP is the only available modality.

The Noridian LCD outlines coverage the is based on the DAWN and DEFUSE 3 trials and as such allows coverage within the parameters of one of the trials it does not address CTP’s use in acute stroke assessment (Albers 2018, Saposnik 2018).

7

One comment addressed baseline modified Rankin Score (mRS).

The coverage outlined in the Noridian LCD adheres to the criteria set forth in the DAWN and DEFUSE 3 trials that is recommended AHA/ASA (Albers 2018, Saposnik 2018).

8

Another comment would like to set aside the baseline NIHSS.

The coverage outlined in the Noridian LCD adheres to the criteria set forth in the DAWN and DEFUSE 3 trials that is supported AHA/ASA (Albers 2018, Saposnik 2018).

9

A comment/correction was made regarding the Background section, second paragraph, 5th sentence recommending changing millimeters of blood to milliliters.

Noridian thanks you for bringing it to our attention and will make the correction.

10

The comment suggesting rewording the second sentence of the 5th paragraph under the Summary of Evidence section to read, “In patients with NIHSS ≥6, (1) penumbra volume ≥15 ml, (2) penumbra to core ratio ≥1.8, and (3) core volume ≤70 ml were used as imaging eligibility criteria to select patients for late EVT (where penumbra volume is the perfusion-core mismatch which is defined as the Tmax>6s volume minus core volume, and the core volume is measured by CTP or MRI diffusion).”

Noridian has no objection to making this change in the interest of clarity.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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