Measure Description
Patients with physician-specific risk-standardized rates of procedural complications following the first time implantation of an ICD
Instructions
This measure is to be submitted a minimum of once per performance period for patients with a first time implantation of an ICD during the performance 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: Include only patients that have had first time implantation through November 30 for evaluation of complications for 30 days and September 30 for evaluation of complications for 90 days post procedure within the performance period. This will allow the evaluation of ICD implant complications within the performance period.
This is a risk-adjusted measure. Please refer to the “Hierarchical logistic regression” at the end of this specification.
This measure will be calculated with 2 performance rates:
1) Complications or mortality at 30 days
2) Complications at 90 days
Measure Submission Type:
Measure data may be submitted by individual MIPS eligible clinicians, groups, or third party intermediaries. The listed denominator criteria is 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.
THERE ARE TWO SUBMISSION CRITERIA FOR THIS MEASURE:
1) Patients with first time implants with one or more complications or mortality within 30 days
AND
2) Patients with first time implants with one or more complications within 90 days
The eligible clinician should submit data on both submission criteria 1 and 2 for a patient that meets the denominator..
SUBMISSION CRITERIA 1: ALL PATIENTS WITH FIRST TIME IMPLANTS WITH ONE OR MORE OF THE IDENTIFIED COMPLICATIONS OR MORTALITY WITHIN 30 DAYS
Denominator (Submission Criteria 1)
Patients aged ≥ 65 years of age with a first time implantation of an ICD performed ≥ 31 days prior to the end of the performance period.
Denominator Criteria (Eligible Cases):
Patient aged ≥ 65 years on date of encounter
AND
Procedure code for Implantation of ICD (ICD-10-PCS): 0JH608Z, 0JH609Z, 0JH638Z, 0HJ639Z, 0JH808Z, 0JH809Z, 0JH838Z, or 0JH839Z
AND/OR
Patient encounter during performance period (CPT): 33240 or 33249, with or without 33216 or 33217
AND NOT
DENOMINATOR EXCLUSIONS:
Procedure code for removal of prior ICD (ICD-10-PCS): 0JPT0PZ, 0JPT3PZ
AND/OR
Patient encounter for removal of prior ICD (CPT): 33241, 33262, 33263, 33264
Numerator (Submission Criteria 1)
Number of patients with one or more of the following complications or mortality within 30 days (depending on the complication) following ICD implantation
Definition:
Complications measured for 30 days:
1. Death
2. Pneumothorax or hemothorax plus a chest tube
3. Hematoma plus a blood transfusion or evacuation
4. Cardiac tamponade or pericardiocentesis
Numerator Instructions:
INVERSE MEASURE - A lower calculated performance rate for this measure indicates better clinical care or control. The “Performance Not Met” numerator option for this measure is the representation of the better clinical quality or control. Submitting that numerator option will produce a performance rate that trends closer to 0% as quality increases. For inverse measures, a rate of 100% means all of the denominator eligible patients did not receive the appropriate care or were not in proper control.
Numerator Options:
Performance Met: Documentation of patient with one or more complications or mortality within 30 days (G9267)
OR
Performance Not Met: Documentation of patient without one or more complications and without mortality within 30 days (G9269)
OR
SUBMISSION CRITERIA 2: ALL PATIENTS WITH FIRST TIME IMPLANTS WITH ONE OR MORE OF THE IDENTIFIED COMPLICATIONS WITHIN 90 DAYS
Denominator (Submission Criteria 2)
Patients aged ≥ 65 years of age with a first time implantation of an ICD performed ≥ 91 days prior to the end of the performance period
Denominator Criteria (Eligible Cases):
Patient aged ≥ 65 years on date of encounter
AND
Procedure code for Implantation of ICD (ICD-10-PCS): 0JH608Z, 0JH609Z, 0JH638Z, 0JH639Z, 0JH808Z, 0JH809Z, 0JH838Z, 0JH839Z
AND/OR
Patient encounter code during performance period (CPT): 33240 or 33249, with or without 33216 or 33217
AND NOT
DENOMINATOR EXCLUSIONS:
Procedure code for removal of ICD (ICD-10-PCS): 0JPT0PZ or 0JPT3PZ
AND/OR
Patient encounter for removal of ICD (CPT): 33241, 33262, 33263, or 33264
Numerator (Submission Criteria 2)
Number of patients with one or more of the following complications within 90 days (depending on the complication) following ICD implantation
Definition:
Complications measured for 90 days:
1. Mechanical complications requiring a system revision
2. Device related infection
3. Additional ICD implantation
Numerator Instructions:
INVERSE MEASURE - A lower calculated performance rate for this measure indicates better clinical care or control. The “Performance Not Met” numerator option for this measure is the representation of the better clinical quality or control. Submitting that numerator option will produce a performance rate that trends closer to 0% as quality increases. For inverse measures, a rate of 100% means all of the denominator eligible patients did not receive the appropriate care or were not in proper control, and therefore an inverse measure at 100% does not qualify for submitting purposes; however, any performance rate less than 100% does qualify.
Numerator Options:
Performance Met: Documentation of patient with one or more complications within 90 days (G9268)
OR
Performance Not Met: Documentation of patient without one or more complications within 90 days (G9270)
Rationale
The proposed measure of ICD complications has the potential to significantly improve the quality of care delivered to patients with advanced heart disease. The model used for risk adjustment meets recognized standards for outcomes measurement and was developed with extensive input from stakeholders with a broad range of expertise and perspectives. The study sample is appropriately defined, consisting of an ICD population that has distinct outcomes that will allow for valid comparisons of physician quality. The definition of the complications, the complication-specific period of assessment, and the risk-adjustment variables all have strong face validity, which may facilitate physician acceptance. We excluded covariates that we would not want to adjust for in a quality measure.
In summary, we present an ICD complications measure that is suitable for public submission. The proposed measure capitalizes on the National Cardiovascular Data Registry (NCDR) ICD Registry data already collected as part of an ongoing collaboration between CMS and NCDR. Accordingly, the incremental burden of data collection on physicians would be minimal and the proposed measure could be implemented by using the direct patient identifiers already being collected by CMS.
Clinical Recommendation Statements
ICD implantation is an expensive procedure performed on patients with advanced cardiovascular disease and, often, significant comorbidities. Despite improvements in technology and increasing experience with device implantation, the procedure carries a significant risk of complications (Hammill and Curtis, 2008).
• Roughly 150,000 ICDs are implanted each year and approximately two thirds of implantations are performed on Medicare patients.
• Direct total medical cost per device (2005) (Sanders, Hlatky, et al., 2005) is $68,000-$100,000. The total national costs range from $10-$15 billion, of which $7-$10 billion represents fee-for-service (FFS) Medicare.
• Complications are expensive and, in one study (Reynolds et al., 2006), associated with increased length of stay (1-10 days) and costs $5,000-$20,000 (mean $7,251), adding roughly $80 million in Medicarecosts.
• Reported complication rates following ICD implantation vary from 4% to 30%, depending largely on how complications are defined and the period of assessment. In the NCDR ICD Registry, the incidence of in-hospital complications is approximately 4%. However, complications such as device infection, malfunction, or cardiac tamponade are not fully captured by the registry since they may only become evident following hospital discharge.
• Al-Khatib et al. (2008) analyzed administrative claims data and found overall rates of complication within 90 days of ICD implantation ranged from 18.8% in 2002 to 14.2% in 2005 (Al-Khatib et al., 2008).
We analyzed Medicare FFS administrative claims to assess complications rates following ICD implantation. From 2006 through 2009, a total of 105,575 implants performed by 3,488 physicians met inclusion/exclusion criteria and were included in the analysis. The number of eligible implants increased over time from 22,931 in 2006 to 28,383 in 2009. The overall complication rate decreased modestly over this time period, from 8.60% to 7.55%. The rate of mechanical complications requiring system revision had the largest decrease over time (0.78%), but similar relative declines were seen across all complications. As expected, the characteristics of patients with and without adverse events differed significantly. Most notably, patients receiving a cardiac resynchronization therapy defibrillator (CRT-D) device had a significantly higher complication rate than patients receiving a single and dual chamber device (8.09%, 6.30%, and 5.33% respectively). These results demonstrate an opportunity to improve physician-level performance.
Hierarchical logistic regression
The specification is designed to align with the NQF-endorsed Hospital Risk-Standardized Complication Rate following Implantation of Implantable Cardioverter-Defibrillator performance measure (NQF #0694).
The variables apply to both the 30- and 90-day outcomes, but how the variables are to be utilized within the performance calculation is part of a risk model developed by Yale University.