Percentage of patient months of pediatric (< 18 years old) in-center hemodialysis patients (irrespective of frequency of dialysis) with documented monthly nPCR measurements.
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1.5 Measure Type1.6 Composite MeasureNo1.7 Electronic Clinical Quality Measure (eCQM)1.8 Level Of Analysis1.9 Care Setting1.9b Specify Other Care SettingDialysis Facility1.10 Measure Rationale
For in-center hemodialysis patients, nPCR provides an estimate of dietary protein intake, which has been shown to provide additional information to spKt/V. Studies have shown that in adolescent patients who achieved target spKt/V levels, nPCR was associated with nutritional status. Furthermore, there is evidence that nPCR < 1 gram/kg/day is predictive of malnutrition and sustained weight loss among adolescent patients.
1.11 Measure Webpage1.20 Testing Data Sources1.25 Data SourcesEQRS is the primary basis for placing patients at dialysis facilities and dialysis claims are used as an additional source. Information regarding first ESRD service date, death, age and incident comorbidities adjustments and transplant is obtained from EQRS (including the CMS Medical Evidence Form (Form CMS-2728) and the Death Notification Form (Form CMS-2746)) and Medicare claims, as well as the Organ Procurement and Transplant Network (OPTN) and the Social Security Death Master File.
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1.14 Numerator
Number of patient months in the denominator with monthly nPCR measurements.
1.14a Numerator DetailsThe number of patients in the study month where (1) the nPCR value and the date the nPCR value was collected are reported or (2) the following 7 components used to calculate nPCR are reported (BUN pre-dialysis, BUN post-dialysis, pre-dialysis weight, pre-dialysis weight unit of measure, post-dialysis weight, post-dialysis weight unit of measure, delivered minutes of BUN hemodialysis session), and the date of collection.
Note: Interdialytic time is also needed to calculate nPCR; however, EQRS currently does not allow collection of that data element therefore the measure does not require reporting of this variable.
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1.15 Denominator
Number of all patient months for pediatric (less than 18 years old) in-center hemodialysis patients (irrespective of frequency of dialysis).
1.15a Denominator DetailsA treatment history file is the data source for the denominator calculation used for the analyses supporting this submission. This file provides a complete history of the status, location, and dialysis treatment modality of an ESRD patient from the date of the first ESRD service until the patient dies or the data collection cutoff date is reached. For each patient, a new record is created each time he/she changes facility or treatment modality. Each record represents a time period associated with a specific modality and dialysis facility. EQRS is the primary basis for placing patients at dialysis facilities and dialysis claims are used as an additional source of information in certain situations. Information regarding first ESRD service date, death, and transplant is obtained from EQRS (including the CMS Medical Evidence Form (Form CMS-2728) and the Death Notification Form (Form CMS-2746)) and Medicare claims, as well as the Organ Procurement and Transplant Network (OPTN).
1.15d Age GroupChildren (0-17 years)
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1.15b Denominator Exclusions
Exclusions that are implicit in the denominator definition include adult patients (greater than or equal to 18 years of age), all patients who have not been in the facility for the entire reporting month, and all home hemodialysis and peritoneal dialysis patients. There are no additional exclusions for this measure.
1.15c Denominator Exclusions DetailsThere are no additional or explicit exclusions beyond what is embedded in the denominator's definition.
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1.13 Attach Data Dictionary1.13a Data dictionary not attachedNo1.16 Type of Score1.17 Measure Score InterpretationBetter quality = Higher score1.18 Calculation of Measure Score
To be included in the denominator for a particular month, the patient must be on in-center hemodialysis for the entire month, must be < 18 years old at the beginning of the month, and must be assigned to that facility for the entire month. An individual patient may contribute up to 12 patient-months per year.
The numerator counts the number of patients in the study month where (1) the nPCR value and the date the nPCR value was collected are reported or (2) the components that allow calculation of nPCR are reported (BUN pre-dialysis, BUN post-dialysis, pre-dialysis weight, pre-dialysis weight unit of measure, post-dialysis weight, post-dialysis weight unit of measure, delivered minutes of BUN hemodialysis Session and the date of collection).
Note: Interdialytic time is also needed to calculate nPCR; however, EQRS currently does not allow collection of that data element, therefore the measure does not require reporting of that variable.
1.18a Attach measure score calculation diagram, if applicable1.19 Measure Stratification DetailsThe measure is not stratified.
1.26 Minimum Sample SizePublic reporting of this measure on DFCC would be restricted to facilities with at least 11 eligible patients for the measure to comply with restrictions on reporting of potentially patient identifiable information related to small cell size. We have applied this restriction to all the reliability and validity testing reported here.
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StewardCenters for Medicare & Medicaid ServicesSteward Organization POC EmailSteward Organization URLSteward Organization Copyright
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Measure Developer Secondary Point Of ContactUnited States
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2.1 Attach Logic Model2.2 Evidence of Measure Importance
The primary source of evidence for this measure is the KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access.
The guideline states:
“8.2.2 Assessment of nutrition status is an essential component of HD adequacy measurement. nPCR should be measured monthly by using either formal urea kinetic modeling or algebraic approximation. (B)
2008 KDOQI CPR RECOMMENDATION 1: EVALUATION OF GROWTH AND NUTRITIONAL STATUS
1.1 The nutritional status and growth of all children with CKD stages 2 to 5 and 5D should be evaluated on a periodic basis. (A)
1.2 The following parameters of nutritional status and growth should be considered in combination for
evaluation in children with CKD stages 2 to 5 and 5D. (B)
- Dietary intake (3-day diet record or three 24-hour dietary recalls)
- Length- or height-for-age percentile or standard deviation score(SDS)
- Length or height velocity-for-age percentile or SDS
- Estimated dry weight and weight-for-age percentile or SDS
- BMI-for-height-age percentile or SDS
- Head circumference-for-age percentile or SDS (=3 years old only)
Normalized protein catabolic rate (nPCR) in hemodialyzed adolescents with CKD stage 5D.”
National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: Hemodialysis Adequacy, Peritoneal Dialysis Adequacy and Vascular Access. Am J Kidney Dis 48:S1-S322, 2006 (suppl 1).
http://www.kidney.org/PROFESSIONALS/kdoqi/guideline_upHD_PD_VA/index.htm
The 2006 KDOQI Guideline 8.2.2 rating strength grade is ‘B’. The recommendation for Grade B guidelines states ‘It is recommended that clinicians routinely follow the guideline for eligible patients. There is moderate to strong evidence that the practice improves health outcomes.’
In May 2014, an additional literature search was performed. A recent comprehensive review on the subject [4] is included in the citations below as a result of that search. This review continues to be supportive of the concept of monitoring nPCR as part of evaluation of Protein Energy Wasting (PEW) in children/adolescents on dialysis.
- Goldstein, Baronette, et al. nPCR assessment and IDPN treatment of malnutrition in pediatric hemodialysis patients. Pediatric Nephrology (2002) 17:531-534.
- Orellana P, Juarez-Congelosi M, Goldstein SL. Intradialytic parenteral nutrition treatment and biochemical marker assessment for malnutrition in adolescent maintenance hemodialysis patients. J Ren Nutrition 2005 Jul;15(3):312-7.
- Juarez-Congelosi M, Orellana P, Goldstein SL: Normalized protein catabolic rate versus serum albumin as a nutrition status marker in pediatric patients receiving hemodialysis. J Ren Nutr 17:269-274, 2007.
- Mastrangelo A, Paglialonga F, Edefonti A. Assessment of nutritional status in children with chronic kidney disease and on dialysis. Pediatr Nephrol. 2014 Aug;29(8):1349-58. doi: 10.1007/s00467-013-2612-7. Epub 2013 Sep 5.
An additional literature search was performed for the Fall 2024 cycle and no additional relevant publications were identified to support the measure. ISPD Guidelines did not address adequacy in children.
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2.6 Meaningfulness to Target Population
Direct Evidence: due to the small number of pediatric patients, and sensitivity to their privacy, we have never collected patient level data on the perception of this measure. In addition, we are not aware of peer-reviewed literature that reports on pediatric dialysis patients’ perception of the meaningfulness of the measure.
Indirect Evidence: A kidney dietician is required to be available in all Medicare-certified dialysis clinics. This is particularly important for pediatric patients whose growth is monitored closely. Maintaining adequate protein intake, while being mindful of other minerals such as calcium and phosphorus, are critical for pediatric patients to achieve optimal growth. Therefore, a metric to track protein intake is meaningful to patients who want to achieve normal stature.
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2.4 Performance Gap
After applying all exclusion criteria, we evaluated the nPCR performance scores for all dialysis facilities that had at least 11 patients in 2022 (n=23). The nPCR varies considerably across this small group of facilities, largely due to poor performance within the bottom quartile. The mean value of nPCR was 0.87 (i.e. 87% of pediatric patients had documented monthly nPCR measurements). The interquartile range (Q3-Q1) is around 0.13, with the bottom quartile of facilities having 85% or less of pediatric patients with documented nPCR measurements versus the top quartile of facilities having 98% or more of their patients with documented measurements. These are the following statistics of performance: Mean (SD) = 87% (20%), Min = 12%, 25th percentile = 85%, 50th percentile = 97%, 75th percentile = 98%, Max = 100%.
Note about Table 1: Deciles were defined differently between Tables 1 and 2. In Table 1, facilities are grouped and ranked according to ascending performance score. In Table 2, ranking is calculated on the basis of ascending facility size.
Table 1. Performance Scores by DecilePerformance Gap Overall Minimum Decile_1 Decile_2 Decile_3 Decile_4 Decile_5 Decile_6 Decile_7 Decile_8 Decile_9 Decile_10 Maximum Mean Performance Score 0.873 0.119 0.359 0.647 0.839 0.915 0.952 0.976 0.982 0.984 0.990 1.000 1.000 N of Entities 23 1 2 2 3 2 2 3 2 3 3 1 3 N of Persons / Encounters / Episodes 384 17 36 31 65 37 25 42 24 67 40 17 67
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3.1 Feasibility Assessment
Data collection is accomplished via EQRS, a web-based and electronic batch submission platform maintained and operated by CMS contractors. Publicly reported measures like this one are reviewed on a regular basis by dialysis facility providers and rare instances of inaccurate or missing data are present (based on comments received during facility preview).
3.3 Feasibility Informed Final MeasureNo changes were made
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3.4a Fees, Licensing, or Other Requirements
N/A
3.4 Proprietary InformationNot a proprietary measure and no proprietary components
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4.1.3 Characteristics of Measured Entities
The measured entities used in testing and analysis include reported nPCR or the necessary data elements needed for calculation of nPCR. There are 384 in-center hemodialysis (ICH) pediatric patients from 23 dialysis facilities that have had at least 11 eligible pediatric patients across all regions of the United States.
Public reporting of this measure on DFC or in the ESRD QIP would be restricted to facilities with at least 11 eligible patients in order for the measure to comply with restrictions on reporting of potentially patient identifiable information related to small cell size. We have applied this restriction to all the reliability and validity testing reported here.
Facilities vary in size and include anywhere from 11 to 32 eligible ICH pediatric patients.
4.1.1 Data Used for TestingCalendar year 2022 data derived from a combination of EQRS and Medicare Claims Data.
4.1.4 Characteristics of Units of the Eligible PopulationIn 2022, there were 384 pediatric patients in total, after applying exclusion criteria (i.e., those at small facilities and those older than 18 years). Among them, 46.8% of patients were female, 55.8% were White, 37.0% were Black, 2.12% were Native American/Alaskan Native, 3.7% were Asian/Pacific Islander, 1.3% were Other/Multi-racial, and 30.4% were Hispanic. Please note, the number of patients listed here may not match the total number of patients in Tables 1 and 2 due to patients being counted multiple times if they switched providers during the year.
4.1.2 Differences in DataWe excluded three facilities from reliability testing for which there were no calculated nPCR values in 2022. Because calculation of nPCR requires interdialytic time, which is not currently reported in EQRS, we are unable to calculate nPCR for these facilities.
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4.2.1 Level(s) of Reliability Testing Conducted4.2.2 Method(s) of Reliability Testing
January 2022 – December 2022 EQRS data were used to calculate the inter-unit reliability (IUR) for the overall 12 months to assess the reliability of this measure. The NQF-recommended approach for determining measure reliability is a one-way analysis of variance (ANOVA), in which the between and within facility variation in the measure is determined. The inter-unit reliability (IUR) measures the proportion of the measure variability that is attributable to the between-facility variance. The yearly based IUR was estimated using a bootstrap approach, which uses a resampling scheme to estimate the within facility variation that cannot be directly estimated by ANOVA. We note that the method for calculating the IUR was developed for measures that are approximately normally distributed across facilities. Since this measure is not normally distributed, the IUR value should be interpreted with some caution.
4.2.3 Reliability Testing ResultsThe overall IUR was 0.952, which indicates that about 95.2% of the variation in the measure can be attributed to the between facility differences and 4.8% to the within facility variation.
Note about Table 2: Deciles were defined differently between Tables 1 and 2. In Table 1, facilities are grouped and ranked according to ascending performance score. In Table 2, ranking is calculated on the basis of ascending facility size
Table 2. Accountable Entity–Level Reliability Testing Results by Denominator-Target Population SizeAccountable Entity-Level Reliability Testing Results Overall Minimum Decile_1 Decile_2 Decile_3 Decile_4 Decile_5 Decile_6 Decile_7 Decile_8 Decile_9 Decile_10 Maximum Reliability 0.952 0.9333 0.933 0.938 0.942 0.946 0.950 0.953 0.955 0.961 0.965 0.974 0.976 Mean Performance Score 0.873 96.948 96.948 98.653 98.058 97.649 82.578 79.863 84.783 52.150 91.896 88.178 98.374 N of Entities 23 3 3 2 1 3 2 2 4 2 2 2 1 N of Persons / Encounters / Episodes 384 33 33 24 13 42 30 32 68 39 44 59 32 4.2.4 Interpretation of Reliability ResultsThe IUR suggests this measure is reliable. However, since the distribution of performance scores is skewed, the IUR value should be interpreted with some caution.
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4.3.1 Level(s) of Validity Testing Conducted4.3.1a Provide a rationale for why validity testing is not applicable/was not conducted:
Validity testing was not performed due to the small size of the pediatric population.
4.3.2 Type of accountable entity-level validity testing conducted4.3.2a Why testing not conductedValidity testing was not performed due to the small size of the pediatric population.4.3.3 Method(s) of Validity TestingData elements in EQRS for quality measures that are used in value-based purchasing undergo regular validity testing to ensure accuracy and results are publicly reported. This process involves a medical record review from 300 randomly selected dialysis facilities with up to 10 patients from each facility also being randomly selected. A total of 24 data elements were most recently reviewed from April – June 2023. A nurse review team compares these data elements from the patients chart to what is reported in EQRS. Although the nPCR value is not one of the data elements directly validated as part of this process, some of the data elements that would be used to calculate nPCR are validated such as patient weight and session duration. Other patient-level data elements include: date of birth, date regular dialysis began, admission and discharge date to facility, type of dialysis treatment and date of death. While the urea nitrogen levels are also not directly validated as part of this process, other laboratory values (calcium, phosphorus) are directly validated and findings should be similar across all laboratory values given the automated process used by most dialysis facilities.
4.3.4 Validity Testing ResultsResults of this analysis are notable for the following:
- 96.5% correct matches with 1.6% of entries in either EQRS (0.2%) or Medical Records (1.4%) containing missing information.
- 1.9% incorrect matches
- Date elements showed error rates ranging from 0-2.3%
4.3.5 Interpretation of Validity ResultsThis analysis reveals a high degree of validity for the key data elements used in the measure. Additional details can be found at: https://qualitynet.cms.gov/esrd/data-validation#tab2
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4.4.1 Methods used to address risk factorsRisk adjustment approachOffRisk adjustment approachOffConceptual model for risk adjustmentOffConceptual model for risk adjustmentOff
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5.1 Contributions Towards Advancing Health Equity
We are not providing a response to this optional question.
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6.1.1 Current StatusYes6.1.3 Current Use(s)6.1.4 Program DetailsDialysis Facility Care Compare, https://www.medicare.gov, DFCC helps patients find detailed information about Medicare-certified dialysis facilities. They can compare the services and the quality of care that, United States, All Medicare-certified dialysis facilities that are eligible for the measure and have at least 11 patients (due to public reporting requirements).
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6.2.1 Actions of Measured Entities to Improve Performance
In order for facilities to improve performance on this measure, they must increase collection and reporting of the nPCR value or the data elements necessary to calculate an nPCR value on a monthly basis. Given that these data elements are known and monitored during each dialysis session, and the requirement is only to report one of these each month, it is felt that collecting and reporting these is not difficult to achieve.
6.2.2 Feedback on Measure PerformanceFor DFCC, feedback can be provided any time through contacting the dialysisdata.org helpdesk. Preview periods allow for specific times for facilities review and comment on measure calculations, and provide an opportunity to request a patient list.
6.2.3 Consideration of Measure FeedbackWe reviewed the comments and questions submitted during the DFCC preview periods that have taken place since the original maintenance (2016-present). We have received only a handful of clarification questions since the measure was added to DFCC, likely due to the very small number of facilities that receive a measure score.
6.2.4 Progress on ImprovementGiven that small scale observational studies have shown an association between nPCR and nutritional status among malnourished adolescent patients who achieved target spKt/V levels, we would expect that public reporting of this measure may engage facilities to better monitor the nutrition status of their pediatric patients. With the exception of the most current year, the mean and min values have been steadily increasing since this measure’s inception. Calendar year 2020 was not reported due to CMS's COVID Extraordinary Circumstances Exception (ECE) data policy that restricted the use of EQRS clinical data from a portion of that year.
CY 2017: N = 29, Mean = 76.64%, Std Dev = 32.46%, Min = 0.0%, Max = 99.32%
CY 2018: N = 26, Mean = 78.40%, Std Dev = 25.36%, Min = 0.0%, Max = 100.0%
CY 2019: N = 31, Mean = 90.24%, Std Dev = 13.59%, Min = 37.33%, Max = 100.0%
CY 2021: N = 18, Mean = 92.24%, Std Dev = 10.95%, Min = 57.66%, Max = 100.0%
CY 2022: N = 23, Mean = 87.29%, Std Dev = 20.48%, Min = 11.88%, Max = 100.0%
6.2.5 Unexpected FindingsNone that we are aware of.
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Enter a comment below
ASPN Comments on CBE #1425
OrganizationAmerican Society of Pediatric NephrologyMeasurement of nPCR for Pediatric Hemodialysis Patients
ASN believes that it is important to incorporate a pediatric-specific growth or nutrition measure in the ESRD QIP. While the CBE #1425: Measurement of nPCR for Pediatric Hemodialysis Patients may not be perfect, it is an important step in the right direction. Thus, ASN supports its endorsement. While the underlying data supporting specific values are linked only to adolescent patients, this process measure (if adopted) would ensure that facilities monitor all pediatric patients with the most appropriate measurement currently available.
ASN again thanks you for the opportunity to comment on these measures. For questions, please contact David White, Senior Regulatory and Quality Officer, at [email protected] .
OrganizationAmerican Society of NephrologyComment on CBE #1425: Measurement of nPCR for Pediatric HD Patie
Kidney Care Partners (KCP) appreciates the opportunity to comment on four of the measures that are part of the Partnership for Quality Measurement’s Fall 2024 Measure Cycle. KCP is a coalition of members of the kidney care community that includes the full spectrum of stakeholders related to dialysis care—patient advocates, healthcare professionals, dialysis providers, researchers, and manufacturers and suppliers—organized to advance policies that improve the quality of care for individuals with chronic kidney disease and end stage renal disease (ESRD). We greatly appreciate the PQM undertaking this important work and offer the following comments addressing the ESRD facility-level measures under review.
CBE #1425: Measurement of nPCR for Pediatric Hemodialysis Patients
KCP believes that it is important to incorporate a pediatric-specific growth or nutrition measure in the ESRD QIP. While the CBE #1425: Measurement of nPCR for Pediatric Hemodialysis Patients may not be perfect, it is an important step in the right direction. Thus, KCP supports its endorsement. While the underlying data supporting specific values are linked only to adolescent patients, this process measure (if adopted) would ensure that facilities are monitoring all pediatric patients with the most appropriate measurement currently available.
KCP again thanks you for the opportunity to comment on this these measures. If you have any questions, please do not hesitate to contact Kathy Lester, JD, MPH.
OrganizationKidney Care Partners
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This measure is described as a percentage of patient months of pediatric (< 18 years old) in-center hemodialysis patients (irrespective of frequency of dialysis) with documented monthly nPCR measurements. ASPN believes that the nPCR measure is reasonable as a reporting measure as a start for a pediatric assessment of nutrition. Currently, there is only outcome data for adolescents with nPCR greater than 1. Therefore, ASPN supports the endorsement of this measure.