For patients 18 years of age and older who had a lumbar fusion procedure, functional status is rated by the patient as less than or equal to 22 OR a change of 30 points or greater on the Oswestry Disability Index (ODI version 2.1a)* at one year (9 to 15 months) postoperatively
* hereafter referred to as ODI
This measure is to be submitted each time a patient undergoes a lumbar fusion during the denominator identification period. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.
NOTE: This measure is a target-based measure with two ways to meet the numerator; either a postoperative ODI score that is less than or equal to 22 OR a change of 30 points or greater from the preoperative to postoperative score. It is expressed as a proportion or rate. Patients having received a lumbar fusion procedure who are not assessed for functional status postoperatively remain in the denominator and are considered as not meeting the target. The measure intent is that MIPS eligible clinicians will submit all denominator eligible procedures for performance calculation.
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.
Patients 18 years of age or older as of October 1 of the denominator identification period who had a lumbar fusion procedure performed during the denominator identification period
Denominator Identification Period - The twelve month period in which eligible patients have a denominator eligible procedure. This allows for enough time for a follow-up assessment to occur during the twelve month performance period. The denominator identification period includes dates of procedure 10/1/2019 to 9/30/2020.
Denominator Criteria (Eligible Cases):
Patients age ≥ 18 years by October 1 of the Denominator Identification Period
Patient procedure during performance period (CPT): 22533, 22558, 22586, 22612, 22630, 22633
Patient had cancer, acute fracture or infection related to the lumbar spine OR patient had neuromuscular, idiopathic, or congenital lumbar scoliosis: M1041
Patients with a diagnosis of lumbar spine region cancer at the time of the procedure – The following codes would be sufficient to define the Denominator Exclusion (M1041) of lumbar spine region cancer: C41.2, C41.4, C79.51, C79.52, D16.6, D16.8, D48.0, D49.2
Patients with a diagnosis of acute lumbar spine region fracture at the time of the procedure – The following codes would be sufficient to define the Denominator Exclusion (M1041) of lumbar spine region fracture: M48.44XA, M48.45XA, M48.46XA, M48.47XA, M48.48XA, M48.54XA, M48.55XA, M48.56XA, M48.57XA, M48.58XA, S22.060A, S22.060B, S22.061A, S22.061B, S22.062A, S22.062B, S22.068A, S22.068B, S22.069A, S22.069B, S22.070A, S22.070B, S22.071A, S22.071B, S22.072A, S22.072B, S22.078A, S22.078B, S22.079A, S22.079B, S22.080A, S22.080B, S22.081A, S22.081B, S22.082A, S22.082B, S22.088A, S22.088B, S22.089A, S22.089B, S24.103A, S24.104A, S24.113A, S24.114A, S24.133A, S24.134A, S24.143A, S24.144A, S24.153A, S24.154A, S32.000A, S32.000B, S32.001A, S32.001B, S32.002A, S32.002B, S32.008A, S32.008B, S32.009A, S32.009B, S32.010A, S32.010B, S32.011A, S32.011B, S32.012A, S32.012B, S32.018A, S32.018B, S32.019A, S32.019B, S32.020A, S32.020B, S32.021A, S32.021B, S32.022A, S32.022B, S32.028A, S32.028B, S32.029A, S32.029B, S32.030A, S32.030B, S32.031A, S32.031B, S32.032A, S32.032B, S32.038A, S32.038B, S32.039A, S32.039B, S32.040A, S32.040B, S32.041A, S32.041B, S32.042A, S32.042B, S32.048A, S32.048B, S32.049A, S32.049B, S32.050A, S32.050B, S32.051A, S32.051B, S32.052A, S32.052B, S32.058A, S32.058B, S32.059A, S32.059B, S32.10XA, S32.10XB, S32.110A, S32.110B, S32.111A, S32.111B, S32.112A, S32.112B, S32.119A, S32.119B, S32.120A, S32.120B, S32.121A, S32.121B, S32.122A, S32.122B, S32.129A, S32.129B, S32.130A, S32.130B, S32.131A, S32.131B, S32.132A, S32.132B, S32.139A, S32.139B, S32.14XA, S32.14XB, S32.15XA, S32.15XB, S32.16XA, S32.16XB, S32.17XA, S32.17XB, S32.19XA, S32.19XB, S32.2XXA, S32.2XXB, S32.9XXA, S32.9XXB, S34.101A, S34.102A, S34.103A, S34.104A, S34.105A, S34.109A, S34.111A, S34.112A, S34.113A, S34.114A, S34.115A, S34.119A, S34.121A, S34.122A, S34.123A, S34.124A, S34.125A, S34.129A, S34.131A, S34.132A, S34.139A, S34.3XXA
Patients with a diagnosis of lumbar spine region infection at the time of the procedure – The following codes would be sufficient to define the Denominator Exclusion (M1041) of lumbar spine region infection: M46.25, M46.26, M46.27, M46.28, M46.35, M46.36, M46.37, M46.38, M46.45, M46.46, M46.47, M46.48, M46.55, M46.56, M46.57, M46.58
Patients with a diagnosis of lumbar neuromuscular, idiopathic, or congenital scoliosis – The following codes would be sufficient to define the Denominator Exclusion (M1041) of neuromuscular, idiopathic, or congenital scoliosis: M41.05, M41.06, M41.07, M41.08, M41.45, M41.46, M41.47, M41.115, M41.116, M41.117, M41.125, M41.126, M41.127, M41.25, M41.26, M41.27, Q67.5, Q76.3
All eligible patients whose functional status is less than or equal to 22 OR a change of 30 points or greater on the Oswestry Disability Index (ODI Version 2.1a) patient reported outcome tool at one year (9 to 15 months) postoperatively
Measure Assessment Period (Performance Period) - The period of time following the procedure date that a postoperative Oswestry Disability Index (ODI version 2.1a) functional status score can be obtained.
Preoperative Assessment Oswestry Disability Index (ODI version 2.1a) - A preoperative ODI functional assessment score can be obtained from the patient any time up to three months preoperatively, inclusive of the date of the procedure. Assessment scores obtained more than three months before the procedure will not be used for measure calculation.
Postoperative Assessment Oswestry Disability Index (ODI version 2.1a) - A postoperative ODI functional assessment score can be obtained from the patient one year (9 to 15 months) after the date of procedure. Assessment scores obtained prior to nine months and after fifteen months postoperatively will not be used for measure calculation.
Oswestry Disability Index (ODI version 2.1a) Patient Reported Outcome Tool - An ODI patient reported outcome tool (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the ‘gold standard’ of low back functional outcome tools. A copy of the tool can be obtained below or at the following link: https://eprovide.mapitrust.org/instruments/oswestry-disability-index
Functional Status Target #1 - A patient who is assessed postoperatively at one year (9 to 15 months) after the procedure rates their functional status as less than or equal to 22.
Functional Status Target #2 - A patient who does not meet Functional Status Target #1 is assessed both preoperatively within 3 months prior to the procedure AND postoperatively at one year (9 to 15 months) after the procedure AND the change is greater than or equal to 30 points
NUMERATOR NOTE: It is recommended that both a preoperative and postoperative tool be administered to the patient to increase the chance that one of the numerator targets will be met. The following situations are those in which the numerator target cannot be reached and Performance Not Met M1043 is submitted.
- ODI is not administered postoperatively at one year (9 to 15 months)
- Functional status is measured using a different patient reported functional status tool or ODI version
- Postoperative ODI is administered less than 9 months or greater than 15 months (1 year window)
- Postoperative ODI is greater than 22 and no valid preoperative ODI to measure change
- Preoperative ODI (to measure change) is administered beyond the three month timeframe prior to and including the date of procedure (e.g. 6 months before procedure.)
Performance Met: Functional status measured by the Oswestry Disability Index (ODI version 2.1a) at one year (9 to 15 months) postoperatively was less than or equal to 22 OR Functional status measured by the ODI version 2.1a within three months preoperatively AND at one year (9 to 15 months) postoperatively demonstrated a change of 30 points or greater (G2142)
Performance Not Met: Functional status was not measured by the Oswestry Disability Index (ODI version 2.1a) at one year (9 to 15 months) postoperatively (M1043)
Performance Not Met: Functional status measured by the Oswestry Disability Index (ODI version 2.1a) at one year (9 to 15 months) postoperatively was greater than 22 AND Functional status measured by the ODI version 2.1a within three months preoperatively AND at one year (9 to 15 months) postoperatively demonstrated a change of less than 30 points (G2143)
Mechanical low back functional status (LBP) remains the second most common symptom-related reason for seeing a physician in the United States. Of the US population, 85% will experience an episode of mechanical LBP at some point in their lifetime. For individuals younger than 45 years, LBP represents the most common cause of disability and is generally associated with a work-related injury. It is the third most common reason for disability for individuals older than 45 years. The prevalence of serious mechanical LBP (persisting > 2 week) is 14%, while the prevalence of true sciatica is approximately 2%.
Overall, spine surgery rates have declined slightly from 2002-2007, but the rate of complex fusion procedures increased 15-fold, from 1.3 to 19.9 per 100,000 Medicare beneficiaries. Complications increased with increasing surgical invasiveness, from 2.3% among patients having decompression alone to 5.6% among those having complex fusions. After adjustment for age, comorbidity, previous spine surgery, and other features, the odds ratio (OR) of lifethreatening complications for complex fusion compared with decompression alone was 2.95 (95% confidence interval [CI], 2.50-3.49). A similar pattern was observed for rehospitalization within 30 days, which occurred for 7.8% of patients undergoing decompression and 13.0% having a complex fusion (adjusted OR, 1.94; 95% CI, 1.74-2.17). Adjusted mean hospital charges for complex fusion procedures were US $80,888 compared with US $23,724 for decompression alone (Deyo, R. JAMA 2010). The MNCM Spine Surgery Measure development workgroup developed patient reported outcome measures for two populations of patients undergoing different lumbar spine procedures, a more complex procedure (lumbar fusion) and a second procedure that represented the most common procedure CPT code 63030 for the most common diagnosis of disc herniation.
Lumbar spine surgery, an effective procedure for many spine conditions, may be controversial and less successful for some patients, particularly those with degenerative disc disease. Utilization data indicate up to a fifteen fold increase in the number of complex fusion procedures performed for Medicare beneficiaries (Trends, major medical complications and charges associated with surgery for lumbar spinal stenosis in adults Deyo, RA JAMA April 2010). News articles convey the experiences of some patients who have an increase in intensity of pain and loss of function after surgery. (Back surgery may backfire on patients in pain- NBC News Oct 2010, Doctors getting rich with fusion surgery debunked by studies- BusinessWeek Jan 2011, Pushing back on back surgery- StarTribune Aug 2009)
This PRO measure was developed with a focus on functional status from a patient’s perspective to address and understand current gaps in care for patients undergoing lumbar fusion surgery. In 2018, the development workgroup reconvened and redesigned the measure construct to a target-based measure.
Rationale for measure construct and calculation change:
Target was derived from a study Determination of the Oswestry Disability Index score equivalent to a "satisfactory symptom state" in patients undergoing surgery for degenerative disorders of the lumbar spine-a Spine Tango registry-based study. vanHooff, ML et al Spine J. 2016 Oct;16(10):1221-1230. Patient Acceptable Symptom State (PASS), the highest level of symptom beyond which patients consider themselves well. PASS was compared to post-op ODI to determine an equivalent ODI threshold. ODI score less than or equal to 22 indicates the achievement of an acceptable symptom state and can be used as a criterion for treatment success. [AUC]: 0.89 [sensitivity: 78.3%, specificity: 82.1%] for 1 year follow-up]. The OR benchmark of change (30) derived from MNCM data (3 years); the average change in points of patients that did achieve the target of less than or equal to 22.
Clinical Recommendation Statements
Journal of Neurosurgery guidelines indicate that there is no evidence that conflicts with the previous recommendations published in the original version of the guideline. This recommendation is for the use of a reliable, valid and responsive outcomes instrument to assess functional outcome in lumbar spinal fusion patients. It is recommended that when assessing functional outcome in patients treated for low-back pain due to degenerative disease, a reliable, valid, and responsive outcomes instrument, such as the disease-specific Oswestry Disability Index (ODI), be used (Level II evidence).
MEASURE CALCULATION EXAMPLE:
|Patient||Pre-op ODI||Post-op ODI||Post-op < 22?||If No, (Pre-op minus Post-op)||If No, Met Change Target > 30?||Met Numerator Target?|