Percentage of adult dialysis patients with a 6-month rolling average phosphorus value greater than or equal to 6.5 mg/dL.
Measure Specs
General Information
The hyperphosphatemia measure was developed based on the recommendations of a clinical TEP’s consideration of the multiple large, risk-adjusted observational studies demonstrating a consistent relationship between presence of hyperphosphatemia and adverse patient outcomes including cardiovascular complications, bone fracture, and increase mortality. In addition, prospective studies have reported lower mortality in patients treated with improved phosphorus control or who used phosphate-binding medications. Currently dialysis facilities report whether a phosphorus level was obtained on a monthly basis, but are not evaluated on how well phosphorus levels are controlled. This measure will help facilities identify patients with chronic elevation in phosphorus that may need additional intervention such as nutritional counseling, phosphorus binding medications or adjustment of dialysis prescription. Improvements in the proportion of patients with a chronically elevated phosphorus should help to decrease cardiovascular complications, hospitalizations, and overall mortality.
Phosphorus values are sourced from EQRS, a mandatory reporting mechanism for all CMS-certified dialysis facilities.
Data for patient placement are derived from an extensive national ESRD patient database, which is primarily based on the Renal Management Information System (REMIS), EQRS facility-reported clinical and administrative data (including CMS-2728 Medical Evidence Form, CMS-2746 Death Notification Form, and CMS-2744 Annual Facility Survey Form and patient tracking data), the Medicare Enrollment Database (EDB), and Medicare dialysis claims data (primarily outpatient). In addition, the database includes transplant data from the Scientific Registry of Transplant Recipients (SRTR), and data from the Nursing Home Minimum Dataset, the Quality Improvement Evaluation System (QIES) Business Intelligence Center (QBIC) (which includes Provider and Survey and Certification data from Automated Survey Processing Environment (ASPEN)), and the Dialysis Facility Care Compare.
Numerator
Number of patient reporting months in the denominator with a 6-month rolling average phosphorus greater than or equal to 6.5 mg/dL.
A patient reporting month is defined as the last month of the six month observation period; for example, for the June 2023 reporting month, the hyperphosphatemia value is the average of the reporting month + the past five months (January – May 2023). August through December of the prior calendar year will be used to calculate the 6-month rolling average for January – May of the current reporting year. The 6-month rolling average phosphorus is calculated by taking the first phosphorus value from the current month and up to 5 prior consecutive calendar months for a given patient. These values are averaged to create a rolling average for the current reporting month. A facility’s patient reporting months are included in the numerator when their 6-month rolling average phosphorus is greater than or equal to 6.5 mg/dL. If there are multiple phosphorus measurements during the month, only the first value in the calendar month will be used for the calculation.
Missing is defined as no phosphorus value in >2 of the six months used in the reporting period. Up to 2 missing phosphorus values are allowed in a 6-month period. If more than 2 missing values are present in the 6-month period, then the patient-month is included in the numerator as having hyperphosphatemia.
Denominator
Number of patient reporting months among adult (greater than or equal to 18 years old) in-center hemodialysis, home hemodialysis, or peritoneal dialysis patients under the care of the dialysis facility for the entire reporting month who have had ESRD for greater than 90 days.
A patient reporting month is included if the patient is >18 years of age, has had ESRD for 90 or more days, and has been receiving treatment at the same facility for the entire calendar month.
The patient’s age will be determined by subtracting the patient’s date of birth from the first day of the most recent month of the reporting period. The patient’s time on dialysis will be determined by subtracting the patient’s date regular chronic dialysis began from the first day of the most recent month of the reporting period. New ESRD patients must be at the same dialysis facility for seven consecutive months before being included in the measure (first three months excluded due to the 90 day ESRD rule above, plus an additional four months to meet minimum number of reporting months to be included in the denominator since two missing months are allowed). Established ESRD patients who transfer to a new facility must have four consecutive months at the new facility to be included in the denominator (since two missing months are allowed). Patients on dialysis are determined as follows: Primary Type of Dialysis is Hemodialysis, Home Hemodialysis, CAPD or CCPD in the most recent month of the reporting period. Patients under the care of the facility for at least 30 days are determined as follows: if the discharge date from the specified facility is missing/null or is after the last day of the most recent month of the reporting period, then the patient’s time under the care of the facility is calculated from the admit date to the last day of the most recent month of the reporting period; if the discharge date is prior to the last day of the most recent month of the reporting period, the patient is excluded from the calculation.
A 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).
Exclusions
In addition to exclusions that are implicit in the measure definition (age <18 years old, <90 days of ESRD, or not receiving treatment at the facility for the full calendar month) there are two additional exclusions:
- 6-month rolling average albumin of less than 3.5 mg/dL
- BMI under 18.5
For a given patient reporting month, the exclusion criteria must not be met within the entire 6-month window used to calculate rolling averages for phosphorus and albumin. Therefore, age and duration of ESRD at start of each rolling average “window” is needed to calculate denominator exclusions, as well as valid albumin and phosphorus values. A patient needs at least 4 out of a possible 6 valid values in the rolling average window to have a valid 6-month rolling average phosphorus or albumin value.
Measure Calculation
Patient reporting months with a 6-month rolling average phosphorus of 6.5 mg/dL or greater are included in the numerator. The number of patient reporting months with a phosphorus average of 6.5 mg/dL or greater is divided by the total number of patient reporting months, by facility. This value is multiplied by 100 to get the percentage of patient reporting months with hyperphosphatemia for each facility (only facilities with greater than 10 patients for the reporting period).
The measure is not stratified.
Public reporting of this measure on Care Compare or in the ESRD QIP 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.
Point of Contact
N/A
Wil Agbenyikey
7500 Security Boulevard
Woodlawn, MD 21244
United States
United States
Importance
Evidence
Kidney disease is almost always associated with complex alterations of mineral metabolism. The magnitude and severity of these alterations typically become more severe with worsening kidney failure and progression to End Stage Kidney Disease (ESKD). Primary mineral alterations include loss of active vitamin D (calcitriol) synthesis by the kidneys and reduced renal clearance of serum phosphorus, leading to hypercalcemia, hyperphosphatemia and secondary hyperparathyroidism. Disruptions have been identified for other interrelated markers such as FGF-23 and circulating Klotho receptor. These primary alterations create a pathologic milieu that, over a period of years, predisposes patients to metabolic bone disease and other complications. (Hamato Kidney Int 106:191-195, 2024; Murray AJKD 83(2):241-256, 2024)
End stage Kidney Disease (ESKD) mineral and bone disease (MBD) has been associated with several adverse clinical outcomes including increased mortality, cardiovascular complications, several bone disorders including osteitis fibrosa cystica (consequent to chronic high-turnover bone disease), osteomalacia (consequent to low turnover bone disease), osteopenia/porosis, among others contributing to the excessive outcome and symptom burden in this population. (Noordzij NDT 21(9):2676-7, 2006; Kestenbaum AJKD 60(1):3-4, 2012; Waheed NDT 28(12):2961-8, 2013; Doshe Kidney Int Reports 2022; Scialla AJKD 77(1):132-141, 2021; KDIGO 2017 Update Kidney Int Supplements 7(1), 2017)
Dialysis facilities and clinical providers have been at the center of efforts to treat ESKD MBD for over fifty years in order to mitigate the deleterious effects of MBD on the individuals they treat. Blood biochemical markers associated with ESKD MBD and its treatments are regularly obtained from almost all US dialysis patients (i.e. monthly blood calcium and phosphorus, alkaline phosphatase and other enzymes reflecting bone metabolic activity; quarterly to annual parathyroid hormone concentrations; etc.). (see Dialysis Facility Care Compare for details) Medicare ESKD Dialysis Facility regulations (Interpretive-Guidance-Version1.1-508.pdf, downloaded from https://www.cms.gov/medicare/health-safety-standards/guidance-for-laws-regulations/dialysis 8/7/2024) specify diagnosis and treatment of ESKD MBD as the responsibility of the dialysis facility’s Interdisciplinary Treatment team (CfC 494, V505, V508, V545, V546). The majority of ESKD dialysis patients are treated with phosphorus binders alone or in combination with other agents to treat MBD. (Hall CJASN 15:1603-13, 2020-) Federal statute require quality metrics that inform policy makers on the effectiveness of ESKD MBD treatment in the US chronic dialysis population. Finally, many national and international evidence-based consensus quality guidelines defining goals for high-quality treatment and prevention of ESKD MBD and its complications have been published and/or updated over the last two decades. (The most recent guideline is: KDIGO 2017 Update Kidney Int Supplements 7(1), 2017)
Historically, extensive observational literature established a strong association between hyperphosphatemia and adverse outcomes (all-cause and/or CV mortality; hospitalization, esp. CV-related) in chronic dialysis patients. A large number of observational studies, mostly at the patient-level, over two decades convincingly demonstrate the consistent association between hyperphosphatemia and clinically important increases in patient adverse outcomes. (Block AJKD 31(4):607-17, 1998; Block JASN 15(8):2208-18, 2004; Ganesh JASN 12(10):2131-2139, 2001; Kalantar-Zadeh Kidney Int 70:771-780, 2006; Young Kidney Int 67(3):1179-87, 2005; Zitt CJASN 6(11):2650-56, 2011; Block CJASN 8:2132-40, 2013; Fukagawa AJKD 63(6):979-87, 2014; Rivara JASN 26(7):1671-81, 2015; Zhang JAMA Network Open 6(5):e2310909, 2023; Kim NDT 2024 online ahead of print.)
The purported mechanisms linking hyperphosphatemia and these outcomes include acceleration of calcific uremic vasculopathy and related cardiovascular, cerebrovascular, and peripheral vascular events either directly, or potentially in part, through stimulation of hyperparathyroidism. (Cannata-Andia Nephrol Dial Transplant. 2002;17 Suppl 11:16-9; Gross Circulation J 78:2339-2346, 2014) More recently, identification of additional circulating hormones associated with MBD in general and hyperphosphatemia specifically (e.g. FGF-23, circulating Klotho receptor, etc.) have increased interest in the potential link between hyperphosphatemia and cardiac hypertrophy and clinical consequences of cardiac hypertrophy on clinical outcomes in this patient population. (Moe Circulation 132(1):27-39, 2015) Experimental laboratory animal models support all of the potential causal mechanisms described above. (Gross Circulation J 78:2339-2346, 2014)
Most ESKD MBD treatment algorithms suggest mitigation of hyperphosphatemia as a foundational component of efforts to reduce the debilitating and potentially lethal complications of this condition. Strategies recommended to control hyperphosphatemia include patient education, counselling, and dietary planning by registered dietitians at each dialysis facility to facilitate dietary phosphorus reduction, reduction of GI tract absorption of phosphorus with dietary phosphorus binders and/or more recently developed GI phosphorus absorption inhibitors, and increasing dialytic clearance of phosphorus with intensified dialysis regimens. (Navaneetham Cochrane Database Systemic Review 16(2), 2011- meta-analysis; Noori CJASN 5(4):683-92, 2010; Floege J Nephrol 33:497-508, 2020; FHN Trial Investigators NEJM 363(24):2287-2300, 2010; Rocco Kidney Int 80(10):1080-91, 2011; Schorr J Renal Nutrition 21(3):271-6, 2011; Ok NDT 26(4):1287-96, 2011; Walsh Hemodialysis Int 14(2):174-81, 2010; Culleton JAMA 298(11):1291-99, 2007; )There are a relatively large number of phosphorus lowering drug trials that demonstrate the ability to reduce phosphorus concentrations. Some of those trials include endpoints that inform on the outcomes of interest. However, there are no placebo-controlled trials that allow determination of the magnitude of effect of these phosphorus-reducing interventions on ESKD patients. (Palmer AJKD 68(5):691-702, 2016- meta-analysis) These phosphorus-control interventions are clearly and unequivocally under the control of the ESKD dialysis interdisciplinary team.
The initial KDIGO Consensus Guidelines for treatment of MBD were published in 2009. In 2017, KDIGO consensus guidelines for treatment of CKD-related MBD updates were published. (KDIGO 2017 Update Kidney Int Supplements 7(1), 2017) The following list, including the 2017 guidelines for control of hyperphosphatemia, summarize the updated guidelines (Section 4.1) relevant to the measure topic presented here.
- 4. 1.1: In patients with CKD G3a to G5D, treatments of CKD–MBD should be based on serial assessments of phosphate, calcium, and PTH levels, considered together. (Not graded)
- 4. 1.2: In patients with CKD G3a to G5D, we suggest lowering elevated phosphate levels toward the normal range. (Grade 2C)
- 4. 1.5: In patients with CKD G3a to G5D, decisions about phosphate-lowering treatment should be based on progressively or persistently elevated serum phosphate. (Not graded)
- 4. 1.8: In patients with CKD G3a to G5D, we suggest limiting dietary phosphate intake in the treatment of hyperphosphatemia alone or in combination with other treatments. (Grade 2D). It is reasonable to consider phosphate source (e.g., animal, vegetable, additives) in making dietary recommendations. (Not graded)
- 4. 1.9: In patients with CKD G5D, we suggest increasing dialysis phosphate removal in the treatment of persistent hyperphosphatemia.(Grade 2C)
Prior to convening a clinical technical expert panel in 2024 charged with recommendation of new quality measures for dialysis facility MBD treatment, the UM-KECC team supplemented the prior KDIGO systematic literature searches by replicating the KDIGO search strategy from the 2017 update, using January. 2015 through early 2024 as the publication search date range. We also searched known sources for both U.S. and international CKD MBD consensus guidelines, published since the KDIGO 2017 update. We identified the 2017 KDIGO Bone and Mineral Guideline Update as the most recent comprehensive guideline set for this topic. Several national and regional international consensus organizations have subsequently commented on the 2017 KDIGO updated guidelines.
One KECC investigator scanned the initial search result set of approximately 16,800 citations to identify extraneous or off-topic results. We excluded any citations not directly related to primary MBD management, focusing primarily on the ESKD chronic dialysis patient population.
After exclusions, our search returned approximately 2600 unique citations of varying quality, including reviews, meta-analyses and original scientific publications. The UM-KECC team identified three primary topics (phosphorus control, clinical lab target values, and treatment of secondary hyperparathyroidism) of interest for our primary review. Three KECC investigators with clinical experience in management of chronic dialysis treatment reviewed the citation set for potentially informative studies related to the clinical topics of interest. Potentially informative citations, including abstract and comments from the primary KECC reviewer, organized by primary topic were provided to our clinical TEP members for review prior to the TEP meetings. In addition, the TEP co-chairs contributed additional related citations to facilitate TEP discussion.
As a result of our supplemental searches, we identified several recent observational studies confirming the association between hyperphosphatemia and patient outcomes previously reported (generally mortality and/or hospitalization). Two of these studies were of particular interest to TEP members and were central to their strong recommendation to develop a quality measure based on chronic hyperphosphatemia with a definition threshold of 6.5 mg/dL for hyperphosphatemia. (Lopes NDT 35:1794-1801, 2020- TAC phos in HD; Lopes NDT 38: 193-202, 2023- TAC phos in PD.) Lopes, in separate publications for in-center hemodialysis and peritoneal dialysis DOPPS populations, described the associations between time-averaged concentration (TAC) of phosphorus over 6 months with patient outcomes. In addition, we identified two prospective observational cohort studies (ArMORR and COSMOS) studies demonstrating associations between use of phosphorous binders and survival, using rigorous risk-adjustment. In the ArMORR study, intent-to-treat analysis with extensive risk adjustment and stratification based on facility-level Standardized Mortality Ratio (SMR) revealed 29% lower mortality in incident patients treated with phosphorus binders. Similar magnitude of mortality reduction was seen in a propensity score matched model. (Isakova JASN 20(2):388-96, 2009) In the COSMOS study using patient-level Propensity Score modeling, phosphorus binder use was associated with approximately 50% and 36% reduction in all-cause and cardiovascular mortality, respectively. (Cannata-Andia Kidney Int 84:998-1008, 2013) The COSMOS study also utilized facility percentage of patients treated with a phosphorus binding agent in an instrumental variable analysis and demonstrated 8% and 7% risk reduction for all-cause and cardiovascular mortality, respectively, for each 10% increase in percent of patients treated with phosphorus binders at the dialysis facility. A 2012 DOPPS study used indicator variable analysis to associate facility level phosphorus control to predict patient outcomes. Subsequently, Block, et al also demonstrated risk reduction in patient mortality for patients treated in dialysis facilities with better MBD treatment outcomes. (Lopes AJKD 60(1):90-101, 2012- includes indicator variable facility-level analyses; Block BMC Nephrol 2016)
Finally, we identified a publication describing secondary analyses of the prospective, case-controlled, Japanese MBD-5D Study. (Fukugawa AJKD 63(6):979-987, 2014) Kato, et al. describe their secondary analyses of the MBD-5D study investigating the association between changing patterns of achieved phosphorus over time with mortality in Japanese chronic dialysis patients. (Kato BMC Nephrol 21: 432, 2020) In this study, individual patient results for phosphorus (and other MBD-related labs) were averaged over 3-month periods and categorized as Low (<4mg/dl), Middle (4-7 mg/dl) and High >7 mg/dl). Risk adjusted mortality in the current 3-month observation period was associated with patient-level achieved phosphorus category in the prior two 3-month periods (e.g. L-L, L-M, L-H, H-H, H-M, H-L) in order to evaluate the short-term effect of phosphorus category change on mortality risk. Compared to patients whose phosphorus category did not change, change from Low to Moderate or from High to Moderate was associated with significantly lower mortality compared to those remaining in the Low and High categories, respectively. Patients moving from Moderate to either Low or High categories were found to have increased mortality relative to the Moderate control group. Although observational in nature, these results from a carefully executed prospective, case-controlled study strongly suggest that treatment of hyperphosphatemia in this population may effect a reduction in mortality, and that avoidance of hypophosphatemia is prudent.
Summary
There is no high-quality direct evidence from prospective interventional clinical trials showing that phosphorus reduction results in better patient outcomes, nor is there evidence supporting one phosphorus lowering technique over others (including phosphorus binder use, GI phosphorus absorption blocker, or dietary/nutritional intervention) as preferred approach in lowering the risk of mortality in this population. There is, however, a large and consistent body of representative observational literature that strongly and consistently supports the clinical association between phosphorus control and reduction of ESKD MBD-related complications. This observational literature clearly demonstrates the association of phosphorus control with better survival in both cross-sectional and prospective cohort studies. In addition, while choice of phosphorus binder class remains under debate, there is evidence that use of any phosphorus binders in this population is associated with significant reduction in all-cause and cardiovascular mortality in studies of patients treated in both the U.S and Europe. Finally, the primary responsibility for treatment of MBD in this population is clearly focused on dialysis facilities and clinicians. It is also important to restate that proven, effective, phosphorus reduction techniques are available and in widespread use worldwide by dialysis providers in the treatment of ESKD chronic dialysis patients.
References
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- Lopes MB, Karaboyas A, Bieber B, et al. Impact of longer term phosphorus control on cardiovascular mortality in hemodialysis patients using an area under the curve approach: results from the DOPPS. Nephrol Dial Transplant. 2020;35(10):1794-1801. doi:10.1093/ndt/gfaa054
- Lopes MB, Karaboyas A, Zhao J, et al. Association of single and serial measures of serum phosphorus with adverse outcomes in patients on peritoneal dialysis: results from the international PDOPPS. Nephrol Dial Transplant. 2023;38(1):193-202. doi:10.1093/ndt/gfac249
- Isakova T, Gutiérrez OM, Chang Y, et al. Phosphorus binders and survival on hemodialysis. J Am Soc Nephrol. 2009;20(2):388-396. doi:10.1681/ASN.2008060609
- Cannata-Andía JB, Fernández-Martín JL, Locatelli F, et al. Use of phosphate-binding agents is associated with a lower risk of mortality. Kidney Int. 2013;84(5):998-1008. doi:10.1038/ki.2013.185
- Lopes AA, Tong L, Thumma J, et al. Phosphate binder use and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS): evaluation of possible confounding by nutritional status. Am J Kidney Dis. 2012;60(1):90-101. doi:10.1053/j.ajkd.2011.12.025
- Block GA, Yusuf AA, Danese MD, et al. Facility-level CKD-MBD composite score and risk of adverse clinical outcomes among patients on hemodialysis. BMC Nephrol. 2016;17(1):166. Published 2016 Nov 4. doi:10.1186/s12882-016-0382-8
- Fukagawa M, Kido R, Komaba H, et al. Abnormal mineral metabolism and mortality in hemodialysis patients with secondary hyperparathyroidism: evidence from marginal structural models used to adjust for time-dependent confounding. Am J Kidney Dis. 2014;63(6):979-987. doi:10.1053/j.ajkd.2013.08.011
- Kato C, Fujii N, Miyakoshi C, et al. Changes in 3-month mineral and bone disorder patterns were associated with all-cause mortality in prevalent hemodialysis patients with secondary hyperparathyroidism. BMC Nephrol. 2020;21(1):432. Published 2020 Oct 12. doi:10.1186/s12882-020-02088-x
Measure Impact
Reducing the number of patient months with chronic hyperphosphatemia is expected to have the following impact: (1) reduction in hospitalization and (2) reduction in all-cause and cardiovascular mortality at the dialysis facility level. The cost-savings from reduced hospitalization rates are offset by increased costs associated with phosphate binder and phosphate absorption inhibiting medications, which are currently not included in the ESRD bundled payment. There are two main unanticipated consequences for the measure. First, the 2024 TEP raised the concern that patients could become malnourished in the process of trying to control chronic hyperphosphatemia. To mitigate against this risk, we exclude patients who are at increased risk for malnutrition as indicated by a low serum albumin or underweight body status as defined by BMI. The other potential unintended consequence relates to the pill burden associated with phosphate binders, their palatability, and the subsequent impact on quality of life.
There is currently no measure of chronic hyperphosphatemia for dialysis patients. There is only a reporting requirement currently that a phosphorus level is being checked on a monthly basis. This is insufficient to assess chronic control of elevated phosphorus. At best, dialysis facilities review on a monthly basis the number of patients who have an elevated phosphorus, but this does not differentiate those patients who have chronically elevated phosphorus levels and are at highest risk for adverse cardiovascular morbidity and mortality.
Although some patients have symptoms related to chronic hyperphosphatemia such as itching or other dermatologic manifestations, many patients are asymptomatic. However, less time spent in the hospital and living longer, particularly if it allows a dialysis patient to reach kidney transplantation, are meaningful outcomes.
Performance Gap
Data are from EQRS Clinical files for years 2021-2022. All reporting months are for calendar year 2022. Data from August 2021 – December 2021 were only used to calculate 6-month rolling averages for the first five months of 2022 which needed data from months prior to January 2022. The total number of dialysis facilities included in the performance scores was 7,497. The total number of patients included in the performance scores was 447,576.
| 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 | 23.1% | 0% | 7.8% | 13.4% | 16.0% | 18.4% | 20.6% | 22.9% | 25.4% | 28.3% | 32.1% | 45.8% | 100% |
| N of Entities | 7497 | 15 | 749 | 750 | 749 | 751 | 749 | 750 | 750 | 746 | 754 | 749 | 28 |
| N of Persons / Encounters / Episodes | 3,758,302 | 2,265 | 299,891 | 379,102 | 403,430 | 412,333 | 408,232 | 409,928 | 396,900 | 400,499 | 366,704 | 281,283 | 7,833 |
Equity
Equity
We elect not to provide a response to this optional question.
Feasibility
Feasibility
Phosphorus levels are routinely checked during routine care delivery in a dialysis facility, and the data is a required submission element for the End Stage Renal Disease Quality Reporting System (EQRS) for Medicare certified dialysis facilities (the measured entity of this measure). All required data elements for the measure are routinely generated during care delivery for dialysis patients. Therefore, there is no additional cost or burden for data collection and no impact on clinical workflow. Given the existing processes in place for data collection, we have no concerns about feasibility if the measure is implemented.
Due to the high feasibility of the measure, no adjustments were needed during measure development to address feasibility.
Proprietary Information
Scientific Acceptability
Testing Data
Data used for testing is from EQRS clinical files for years 2021 and 2022. All reporting months with a 6-month phosphorus average are from 2022, and only phosphorus values in months from 2021 needed to calculate these averages are used from that year.
none
7,497 facilities with 10 or more eligible adult patients during January 2022 – December 2022 were included in the analysis.
Public reporting of this measure on DFC or in the ESRD QIP would be restricted to facilities with at least 10 eligible patients for the measure to comply with restrictions on reporting of potentially patient identifiable information related to small sample size. We have applied this restriction to all the reliability and validity testing reported here.
A total of 447,576 patients who belonged to the facilities with 10 or more patients were included in this analysis. Among these patients, the average age was 63, 41.4% were female, 56.3% were white, 34.7% were black, 20.5% were Hispanic, and 46.0% had diabetes as primary cause of ESRD.
Reliability
We used January 2022 – December 2022 data to calculate the inter-unit reliability (IUR) for the overall 12 months to assess the reliability of this measure. One of the PQM-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.
The overall IUR was 0.767 across 12 reporting months, which is high and suggests 77% of variation in the measure is attributed to between facility variation and approximately 23% to within facility variation.
The overall IUR for the sample dataset was 0.77. The IUR’s per deciles of patients ranged from 0.48 to 0.88. The overall IUR of 0.77 indicates 77% of variation in the overall measure can be attributed to between facility variations. This is considered to be a high degree of reliability.
| | Overall | Minimum | Decile_1 | Decile_2 | Decile_3 | Decile_4 | Decile_5 | Decile_6 | Decile_7 | Decile_8 | Decile_9 | Decile_10 | Maximum |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reliability | 0.767 | 0.356 | 0.476 | 0.590 | 0.652 | 0.694 | 0.728 | 0.757 | 0.783 | 0.810 | 0.839 | 0.883 | 0.951 |
| Mean Performance Score | 23.1% | 0% | 7.8% | 13.4% | 16% | 18.4% | 20.6% | 22.9% | 25.4% | 28.3% | 32.1% | 45.8% | 100% |
| N of Entities | 7497 | 15 | 745 | 775 | 739 | 696 | 795 | 723 | 763 | 754 | 757 | 750 | 28 |
| N of Persons / Encounters / Episodes | 3,758,302 | 2,265 | 91,207 | 159,305 | 203,405 | 233,587 | 318,102 | 338,400 | 418,557 | 495,687 | 611,919 | 888,133 | 7,833 |
Validity
We used January 2022 – December 2022 EQRS clinical data to assess facility level performance scores. 7,497 facilities with 10 or more patients were used for validity testing, which includes 447,576 patients.
We assessed validity using Poisson regression models to identify the predictive strength of facility level performance scores for the measure, on mortality and days hospitalized, using the 2022 SMR and SHR related data. We anticipate a positive correlation with the SMR and SHR, and a dose-response with increasing rate ratios from lowest quintile of hyperphosphatemia to highest quintile of hyperphosphatemia.
Progression Regression with SMR & SHR
Mortality:
Quintile 1, Performance Score: 10.4, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.0 (Reference)
Quintile 2, Performance Score: 17.2, Pr >ChiS q: <0.0468, Rate Ratio (95%CI): 1.03 (95% CI: 1, 1.05)
Quintile 3, Performance Score: 21.7, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.06 (95% CI: 1.04, 1.09)
Quintile 4, Performance Score: 26.8, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.09 (95% CI: 1.06, 1.11)
Quintile 5, Performance Score: 38.9, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.18 (95% CI: 1.16, 1.21)
Hospitalization:
Quintile 1, Performance Score: 10.4, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.0 (Reference)
Quintile 2, Performance Score: 17.2, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.04 (95% CI: 1.04, 1.05)
Quintile 3, Performance Score: 21.7, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.03 (95% CI: 1.03, 1.04)
Quintile 4, Performance Score: 26.8, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.07 (95% CI: 1.06, 1.07)
Quintile 5, Performance Score: 38.9, Pr >ChiS q: <0.0001, Rate Ratio (95%CI): 1.13 (95% CI: 1.12, 1.13)
The results of the Poisson regression suggests that facilities with a higher percentage of patient-months with chronic hyperphosphatemia experience a higher mortality rate and higher hospitalization rate relative to facilities with a lower percentage of patients with chronic hyperphosphatemia. Using quintiles defined by mean facility performance score, we find that facilities in the 5th quintile have mortality that is 18% higher when compared to facilities in the 1st quintile group. Similarly, facilities in the 5th quintile have hospitalization that is 13% higher when compared to facilities in the 1st quintile group. The direction of the relationship is as expected.
Risk Adjustment
Use & Usability
Use
Usability
Actions that dialysis facilities can take to improve long-term phosphorus control include nutritional counseling to help patients choose low phosphorus foods as part of their nutrition plan, prescription of phosphorus binding agents, and potentially adjustment of dialysis prescription to maximize phosphorus clearance. These interventions can be challenging, but coordinated effort by the interdisciplinary team can overcome obstacles such as prescription coverage for medications, improved adherence with a nutrition plan, and optimal dialysis.
Comments
Staff Preliminary Assessment
CBE #4650 Staff Assessment
Importance
Strengths:
- Logic Model: A clear logic model is provided, depicting the relationships between inputs (identification of patients with chronically elevated phosphorus levels by an interdisciplinary team), activities (educating patients on nutritional strategies, encouraging the use of phosphate binding medications, managing the delivered dose of dialysis), and desired outcomes (decreased likelihood of hospitalizations, bone fractures, and death; improved quality of care; increased patient quality of life). This model demonstrates how the measure's implementation will lead to the anticipated outcomes.
- Evidence and Literature Review: The measure is supported by a comprehensive, well-graded literature review including systematic reviews and clinical practice guidelines that demonstrate a clear net benefit in terms of improved outcomes for hyperphosphatemia in dialysis patients.
- Performance Gap: Data from EQRS Clinical files for years 2021-2022 shows a performance gap, with decile ranges from 7.8% to 45.8%, indicating substantial variability in measure performance across the target population.
- Anticipated Impact: If implemented, the developer posits the measure’s anticipated impact on important outcomes is expected to be a decrease in cardiovascular complications, hospitalizations, and overall mortality, based on evidence from various studies and guidelines.
- Business Case: Overall, the developer provides strong evidence of significant improvements in patient outcomes due to effective management of chronic hyperphosphatemia, with a well-documented, strong business case for the measure’s relevance and necessity in improving health care outcomes.
- Existing Measures: The proposed measure addresses a healthcare need not sufficiently covered by existing measures, offering advantages in terms of assessing chronic control of elevated phosphate levels.
- Patient Input: There is no explicit mention of patients finding the measure valuable or meaningful, however, the various literature cited by the developer demonstrate an improved quality of care and an increase in patient's quality of life from improved phosphate control.
Limitations:
- None.
Rationale:
- This new measure meets all criteria for "Met" due to its robust, well-graded evidence base, clear business case, documented performance gap, significant anticipated impact, well-articulated logic model, and addresses the lack of existing measures, making it essential for addressing chronic hyperphosphatemia in dialysis patients.
Feasibility Acceptance
Strengths:
- Feasibility Assessment: A comprehensive feasibility assessment has been conducted, demonstrating that all necessary people, tools, tasks, and technologies have been considered for the implementation of this measure. This includes a detailed analysis of the resources required and the operational steps needed to integrate the measure into current healthcare practices.
- Adjustments Based on Feasibility: There were no adjustments to the measure’s development due to the measure’s high feasibility.
- Data Collection Strategy: Required data are routinely generated and used during care delivery in dialysis facilities, are a required submission element for the End Stage Renal Disease Quality Reporting System (EQRS) for Medicare certified dialysis facilities, and the data collection strategy can be implemented effectively.
- Licensing and Fees: This is not a proprietary measure and there are no proprietary components. There are no fees to use any aspect of the measure.
Limitations:
- None.
Rationale:
- This new measure meets all criteria for 'Met' due to its well-documented feasibility assessment, clear and implementable data collection strategy, and transparent handling of licensing and fees (none specified), ensuring practical implementation within the health care system.
Scientific Acceptability
Strengths:
- Data Sources and Dates: Data used for testing were sourced from EQRS clinical files during the period 7/2021-12/2022. The entities included in the analysis were characterized by facilities with 10 or more eligible patients.
Accountable Entity-Level Reliability: The developer conducted inter-unit reliability testing (IUR) at the accountable entity-level. A bootstrap approach was used to estimate within-entity variance. More than 70% of accountable entities meet the expected threshold of 0.6.
Limitations:
- None.
Rationale:
- Summary: The results demonstrate sufficient reliability at the accountable entity level.
Strengths:
- To substantiate a claim of validity, the developer must demonstrate a causal relationship between the dialysis facility response to the measure and the measure focus (i.e. the number of reporting months with a 6-month rolling average of phosphorus ge to 6.5 mg/dL). The developer provides empirical evidence of a facility-level co-variation between the measure focus and two material outcomes (mortality and hospitalization). The suggested inference is that dialysis facility actions are causing the increase in patient hyperphosphatemia because those same actions are causing (or contributing to) an increase in mortality and hospitalization across various populations and settings. In the case of mortality, that inference is strengthened because the greater the percentage increase in hyperphosphatemia, the greater percentage increase in mortality. That relationship does not hold as strongly for hospitalization, perhaps because of other factors that contribute to hospitalization.
Limitations:
- The analysis does not rule-out that other causes besides the actions of the dialysis facility may be causing both the increase in hyperphosphatemia and the increase in mortality and hospitalization. The claim of validity should be further supported by complementary association studies that rule-out other potential confounding factors (e.g. patient factors or facility factors). In addition, the claim of validity should be further supported by complementary mechanism studies that confirm the existence of a suitable mechanism that is responsible for the increase in hyperphosphatemia (i.e. what do worse performing dialysis facilities not do that better performing dialysis facilities do).
Risk adjustment: This intermediate outcome measure is not risk adjusted. While a risk adjustment evaluation is not required for intermediate outcome measures (and in this case does not affect the rating), a discussion of risk adjustment would strengthen the submission.
Rationale:
- The validity testing results support a moderate inference of validity for the measure, confirming that the measure accurately reflects performance on quality or resource use and can distinguish good from poor performance. The validity claim would be further strengthened by also ruling out other potential causes of co-variation with mortality and hospitalization. The claim can be further supported by confirming a mechanism responsible for the increase seen in outcomes (mortality than hospitalization).
Equity
Strengths:
- The developer did not address this optional domain
Limitations:
- The developer did not address this optional domain
Rationale:
- The developer did not address this optional domain.
Use and Usability
Strengths:
- Planned Use: The measure is currently not in use, but the developer indicates a plan for use in public reporting and payment programs.
- The developer provides a summary of how accountable entities can use the measure results to improve performance. Specifically, dialysis facilities can implement long-term phosphorus control such as nutritional counseling to help patients choose low phosphorus foods as part of their nutrition plan, prescribing phosphorus binding agents, and potentially adjusting dialysis prescription to maximize phosphorus clearance.
Limitations:
- None.
Rationale:
- For initial endorsement, there is a clear plan for use in at least one accountability application, and the measure provides actionable information for improvement.
Committee Independent Review
support
Importance
agree with staff
Feasibility Acceptance
agree with staff
Scientific Acceptability
agree with staff
agree with staff that developer should strengthen their case for the association between dialysis unit responses to the measure and the measure focus
Equity
optional
Use and Usability
agree with staff
Summary
overall, I support this measure
support
Importance
This was well documented and reflected earnestly in the public comments.
Feasibility Acceptance
Well documented.
Scientific Acceptability
Acceptability Reliability is met.
Validity could be better addressed through expanded efforts to understand environmental or other contributing factors showing in results.
Equity
Optional rating, not provided.
Use and Usability
Demonstrates strong use case and usability is expected.
Summary
Nothing to comment.
Summary
Importance
Agree with staff recommendation.
Feasibility Acceptance
Agree with staff recommendation.
Scientific Acceptability
Agree with staff recommendation.
Agree with staff recommendation.
Equity
Agree with staff recommendation.
Use and Usability
Agree with staff recommendation.
Summary
I support this measure.
Support
Importance
Agree with staff
Feasibility Acceptance
Agree with staff
Scientific Acceptability
Agree with staff
Agree with staff
Equity
Agree with staff
Use and Usability
Agree with staff. Need to be very specific about how a 'facility' is defined and presented in the results.
Summary
Agree with staff. Need to be very specific about how a 'facility' is defined and presented in the results.
Approve
Importance
Agree with staff
Feasibility Acceptance
well documented
Scientific Acceptability
acceptable
Agree with staff assessment
Equity
Did not assess
Use and Usability
Clear plan
Summary
Agree with staff assessment
Public Comments
Facility Level Percentage of Chronic Hyperphosphatemia in Dialys
While we appreciate that, with the inclusion of phosphate lowering medications in the prospective payment system, a quality metric can help promote at least some utilization of these agents for individuals with hyperphosphatemia, we are concerned that the proposed metric is not based on data. There currently are no clinical trials that support a specific serum phosphate level target to improve patient outcomes, and neither the currently proposed threshold nor the hypoalbuminemia exception in CBE #4650 are supported by quality data. We also question whether there is a significant number of patients with phosphate levels chronically above 6.5 mg/dL that have access to phosphate lowering medications but are not prescribed them. Given the lack of evidence supporting this metric, and our consistent call that metrics included in quality systems should be backed by evidence, we cannot support CBE #4650 at this time. We note that the PHOSPHATE trial is ongoing in Australia, New Zealand, Canada, the United Kingdom, Brazil, Israel and Thailand, and we encourage awaiting these results rather than prematurely promoting a metric that is unsupported by data. In the interim, given the changes in the prospective payment system, we encourage CMS to monitor phosphate lowering medication and serum phosphorus levels among maintenance dialysis patients.
Response to public comment
We appreciate that much of the literature regarding bone and mineral disorder centers around observational studies. However, this is true in many areas of Nephrology practice and has not precluded the development of other endorsed measures. After an extensive review of the literature that was reviewed with our TEP, two studies were of particular interest and were central to their strong recommendation to develop a quality measure based on chronic hyperphosphatemia with a definition threshold of 6.5 mg/dL for hyperphosphatemia. This research in HD and PD patients in the DOPPS study (NDT 35:1794-1801, 2020; Lopes et al, NDT 38: 193-202, 2023) described the associations between time-averaged concentration of phosphorus of >6.5 over 6 months with patient outcomes. In addition, we identified two prospective observational cohort studies (ArMORR and COSMOS) studies demonstrating associations between use of phosphorous binders and survival. Finally, at the facility-level, there are studies that demonstrate risk reduction in patient mortality for patients treated in dialysis facilities with better MBD treatment outcomes. Overall, the body of evidence supports a quality measure of chronic hyperphosphatemia, and we will continue to evaluate the peer-reviewed literature as part of the measure maintenance cycle.
Comments on CBE #4650: Facility Level Percentage of Chronic Hype
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 four ESRD facility-level measures under review.
CBE #4650: Facility Level Percentage of Chronic Hyperphosphatemia in Dialysis Patients
KCP continues to believe that it is important to develop a measure to address bone and mineral disorders (MBD) in individuals experiencing kidney failure. National USRDS data highlight an increasing performance gap in phosphorus management, in contrast to the consistently stable calcium management. Clinicians rely upon the serum phosphorous measure to make clinical decisions related to the treatment of MBD. We recognize that there is disagreement within the community as to the most appropriate target level for phosphorus. Yet addressing the issue remains critically important. If MBD is not effectively managed, these individuals could experience hyperphosphatemia, which can increase risk of mortality, vascular calcification, and cardiovascular events.