Measure Description
Percentage of patients aged 18 years and older with a diagnosis of acute ischemic stroke who arrive at the hospital within 3.5 hours of time last known well and for whom IV thrombolytic therapy was initiated within 4.5 hours of time last known well.
Instructions
This measure is to be submitted for each episode of acute ischemic stroke for patients who arrive at the hospital within 3.5 hours of time last known well and for whom IV thrombolytic therapy was initiated within 4.5 hours of time last known well. It is anticipated that Merit-based Incentive Payment System (MIPS) eligible clinicians providing care for patients with acute ischemic stroke in the hospital setting will submit this measure.
Measure Submission Type:
Measure data may be submitted by individual MIPS eligible clinicians, groups, or third party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.
Denominator
All patients aged 18 years and older with a diagnosis of acute ischemic stroke whose time of arrival is within 3.5 hours (≤ 210 minutes) of time last known well
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years on date of encounter
AND
Diagnosis for ischemic stroke (ICD-10-CM): I63.00, I63.011, I63.012, I63.013, I63.019, I63.02, I63.031, I63.032, I63.033, I63.039, I63.09, I63.10, I63.111, I63.112, I63.113, I63.119, I63.12, I63.131, I63.132, I63.133, I63.139, I63.19, I63.20, I63.211, I63.212, I63.213, I63.219, I63.22, I63.231, I63.232, I63.233, I63.239, I63.29, I63.30, I63.311, I63.312, I63.313, I63.319, I63.321, I63.322, I63.323, I63.329, I63.331, I63.332, I63.333, I63.339, I63.341, I63.342, I63.343, I63.349, I63.39, I63.40, I63.411, I63.412, I63.413, I63.419, I63.421, I63.422, I63.423, I63.429, I63.431, I63.432, I63.433, I63.439, I63.441, I63.442, I63.443, I63.449, I63.49, I63.50, I63.511, I63.512, I63.513, I63.519, I63.521, I63.522, I63.523, I63.529, I63.531, I63.532, I63.533, I63.539, I63.541, I63.542, I63.543, I63.549, I63.59, I63.6, I63.81, I63.89, I63.9
AND
Patient encounter during performance period (CPT): 99221, 99222, 99223, 99231, 99232, 99233, 99281, 99282, 99283, 99284, 99285, 99291
WITHOUT
Telehealth Modifier (including but not limited to): GQ, GT, 95, POS 02
AND
Time last known well to hospital arrival less than or equal to 3.5 hours (≤ 210 minutes)
Numerator
Patients for whom IV thrombolytic therapy was initiated at the hospital within 4.5 hours (≤ 270 minutes) of time last known well
Definition:
Last Known Well – The date and time prior to hospital arrival at which it was witnessed or reported that the patient was last known to be without the signs and symptoms of the current stroke or at his or her baseline state of health.
NUMERATOR NOTE: Updated clinical practice guidelines recommend this extended timeframe for thrombolytics, however, earlier intervention is preferred and leads to better outcomes. Patients who are eligible for thrombolytics should receive treatment as quickly as possible after arrival at the hospital.
Numerator Options:
Performance Met: IV thrombolytic therapy initiated within 4.5 hours (≤ 270 minutes) of time last known well (G8600)
OR
Denominator Exception: IV thrombolytic therapy not initiated within 4.5 hours (≤ 270 minutes) of time last known well for reasons documented by clinician (e.g. patient enrolled in clinical trial for stroke, patient admitted for elective carotid intervention, patient received tenecteplase (TNK)) (G8601)
OR
Performance Not Met: IV thrombolytic therapy not initiated within 4.5 hours (≤ 270 minutes) of time last known well, reason not given (G8602)
Rationale
One trial (ECASS III) specifically evaluating the efficacy of IV alteplase within 3 and 4.5 hours after symptom onset and pooled analysis of multiple trials testing IV alteplase within various time windows support the efficacy of IV alteplase up to 4.5 hours after symptom onset. ECASS III excluded octogenarians, patients taking warfarin regardless of international normalized ratio, patients with combined history of diabetes mellitus and previous ischemic stroke, and patients with very severe strokes (NIHSS score >25) because of a perceived excessive risk of intracranial hemorrhage in those cases. However, careful analysis of available published data summarized in an AHA/American Stroke Association (ASA) scientific statement indicates that these exclusion criteria from the trial may not be justified in practice.
The WAKE-UP RCT randomized 503 patients with AIS who awoke with stroke or had unclear time of onset and could be treated with IV alteplase within 4.5 hours of stroke symptom recognition. Eligibility required MRI mismatch between abnormal signal on DW-MRI and no visible signal change on FLAIR. DW-MRI lesions larger than one-third of the territory of the MCA, NIHSS score >25, contraindication to treatment with alteplase, or planned thrombectomy were all exclusions. Ninety-four percent were wake-up strokes. Median NIHSS score was 6. Median time from last known well to symptom recognition was ≈7 hours and to alteplase administration slightly over 10 hours. The primary end point of an mRS score 0 to 1 at 90 days was achieved in 53.3% of the alteplase group and in 41.8% of the placebo group (P=0.02). Only 20% had LVO of the intracranial internal carotid or proximal middle cerebral arteries.
Reference: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; on behalf of the American Heart Association Stroke Council. 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:e344–e418 doi: 10.1161/STR.0000000000000211. Available at: https://www.ahajournals.org/doi/abs/10.1161/STR.0000000000000211.
Clinical Recommendation Statements
IV alteplase (0.9 mg/kg, maximum dose 90 mg over 60 minutes with initial 10% of dose given as bolus over 1 minute) is recommended for selected patients who may be treated within 3 hours of ischemic stroke symptom onset or patient last known well or at baseline state. (Class 1, Level of Evidence A)(AHA/ASA).
Reference: 2018 AHA/ASA Acute Ischemic Stroke guidelines: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; on behalf of the American Heart Association Stroke Council. 2018 Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2018; 49:e46–e110.
It may be reasonable to choose tenecteplase (single IV bolus of 0.25- mg/kg, maximum 25 mg) over IV alteplase in patients without contraindications for IV fibrinolysis who are also eligible to undergo mechanical thrombectomy (Class IIB, Level of Evidence B-R)
In patients eligible for IV alteplase, because benefit of therapy is time dependent, treatment should be initiated as quickly as possible and not delayed for additional multimodal neuroimaging, such as CT and MRI perfusion imaging. (Class I, Level of Evidence: B-NR).
IV alteplase (0.9 mg/kg, maximum dose 90 mg over 60 minutes with initial 10% of dose given as bolus over 1 minute) is also recommended for selected patients who can be treated within 3 and 4.5 hours of ischemic stroke symptom onset or patient last known well or at baseline state. Physicians should review the criteria outlined in Table 8 to determine patient eligibility. (Class I, Level of Evidence: B-R)
IV alteplase (0.9 mg/kg, maximum dose 90 mg over 60 minutes with initial 10% of dose given as bolus over 1 minute) administered within 4.5 hours of stroke symptom recognition can be beneficial in patients with AIS who awake with stroke symptoms or have unclear time of onset >4.5 hours from last known well or at baseline state and who have a DW-MRI lesion smaller than one-third of the MCA territory and no visible signal change on FLAIR. (Class IIa, Level of Evidence: B-R)
For patients >80 y of age presenting in the 3- to 4.5-h window, IV alteplase is safe and can be as effective as in younger patients. (Class IIa, Level of Evidence: B-NR)
For otherwise eligible patients with mild disabling stroke symptoms, IV alteplase may be reasonable for patients who can be treated within 3 and 4.5 hours of ischemic stroke symptom onset or patient last known well or at baseline state. (Class IIb, Level of Evidence: B-NR)
In AIS patients with prior stroke and diabetes mellitus presenting in the 3- to 4.5- h window, IV alteplase may be as effective as treatment in the 0- to 3-h window and may be a reasonable option. (Class IIb, Level of Evidence: B-NR)
The benefit of IV alteplase between 3 and 4.5 h from symptom onset for patients with very severe stroke symptoms (NIHSS score >25) is uncertain. (Class IIbm Level of Evidence: C-LD)
Reference: 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: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch E.C, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Stroke. 2019;50:e344–e418