Percentage of adult dialysis patients with a rolling average phosphorus value greater than or equal to 6.5 mg/dL and pediatric dialysis patients with a rolling average phosphorus value greater than or equal to 7.0 mg/dL.
Measure Specs
General Information
The hyperphosphatemia measure was developed based on the recommendations of a clinical Technical Expert Panel’s (TEP) 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.
This measure was originally developed for use in the adult dialysis population (CBE4650) and received endorsement from PQM during the fall 2024 cycle. At that time, the original TEP recommendation was to exclude pediatric patients since we were unable to obtain sufficient input from pediatric providers. After obtaining additional expert input from pediatric dialysis providers over the past year, pediatric (ages 1-17 years old) dialysis patients have been added into the measure. We considered developing a stand-alone pediatric measure, or using age-stratification, but noted several limitations to these approaches related to the small pediatric population. Specifically, there are <1,500 pediatric patients who receive maintenance dialysis and there are only 240 (out of >7,500 dialysis facilities) dialysis facilities that treat pediatric patients. Since the measure is only reported for facilities that have 10 or more patients, this means that only 49 of the 240 facilities that treat pediatric patients would be eligible for a measure score if we had either a stand-alone measure or relied on stratified reporting. As an alternative, including pediatric patients into the existing measure, although with different criteria for the numerator, allows the entire pediatric population to be included.
When dialysis facilities obtain monthly serum phosphorus levels as part of routine clinical care, most clinics have a process to automatically upload these results into EQRS (a mandatory reporting mechanism for all CMS-certified dialysis facilities) in a process referred to as “batch-submission”. Phosphorus values to calculate the measure are sourced from EQRS. We did not encounter any issues related to the data collection that would impact the feasibility, reliability, or validity of the measure.
Data for patient placement at a specific dialysis facility are also primarily based on 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). If needed, supplemental information is obtained from the Renal Management Information System (REMIS), the Medicare Enrollment Database (EDB), and Medicare dialysis claims data when available. In addition, we obtain transplant data from the Scientific Registry of Transplant Recipients (SRTR), and other data from 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 adult patient reporting months in the denominator with a 6-month rolling average phosphorus greater than or equal to 6.5 mg/dL and pediatric patient reporting months with a 3-month (12-17 years old) or 6-month (1-11 years old) rolling average phosphorus greater than or equal to 7.0 mg/dL.
A patient reporting month is defined as the last month of the observation period; There are two different length observation periods based on the patient’s age. For patients age 13 and up, this is a 6-month time period and for patients ages 1-12, this is a 3-month time period. For example, for an adult patient the June 2023 reporting month is the average phosphorus value 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. The 3-month rolling average phosphorus value is calculated by taking the first phosphorus value from the current month and up to 2 prior consecutive calendar months for a given patient (if age is 1-12 years old). 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 rolling average phosphorus is greater than or equal to 6.5 mg/dL for adult patients (ages 18 and up) or greater than or equal to 7.0 mg/dL for pediatric patients (ages 1-17 years of age). If there are multiple phosphorus measurements during the month, only the first value in the calendar month will be used for the calculation.
For the 6-month rolling average, 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. For the 3-month rolling average, missing is defined as no phosphorus value is >1 of the three months used in the reporting period. If more than 1 missing value is present in the 3-month period, then the patient-month is included in the numerator as having hyperphosphatemia.
Please refer to the data dictionary attachment under 1.13a for the list of EQRS data elements.
Denominator
Number of patient reporting months among all 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 >1 year 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 who are 13 and up 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). New ESRD patients who are 1-12 years of age must be at the same dialysis facility for five consecutive months before being included in the measure (first three months excluded due to the 90-day ESRD rule above, plus an additional two months to meet the minimum number of reporting months to be included in the denominator since one missing month is allowed). Established ESRD patients who are over the age of 13 years old 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) while patients ages 1-12 years old who transfer must have two consecutive months at the new facility to be included.
Patients on dialysis are included if the primary Type of Dialysis is In-center Hemodialysis, Home Hemodialysis, CAPD or CCPD in the most recent month of the reporting period. Patients are assigned to a facility if they have had care there for at least 30 days. The patients time under care at the facility is calculated from the admission date to the last day of the most recent month of the reporting period. If the patient is discharged from the facility prior to last day of the most recent month of the reporting period, then the patient is excluded from the denominator.
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 Medicare claims (if available) 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).
Please refer to the data dictionary attachment under 1.13a for the list of EQRS data elements.
Exclusions
In addition to exclusions that are implicit in the measure definition (age <1 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 for patients who greater than or equal to 13 years old.
- BMI under 18.5 for patients greater than or equal to 18 years old.
Please refer to the data dictionary attachment under 1.13a for the list of EQRS data elements.
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.
BMI is calculated from the height and weight that are present on the CMS Form 2728.
Measure Calculation
Patient reporting months with a rolling average phosphorus of 6.5 mg/dL or greater (for patients 18 and older) or 7.0 mg/dL or greater (for patients 1-17 years old) are included in the numerator. The number of patient reporting months with an elevated phosphorus 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.
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.
Measure Record
Point of Contact
Not applicable
Wilfred Agbenyikey
Baltimore, MD
United States
Jonathan Segal
University of Michigan Kidney Epidemiology and Cost Center
Ann Arbor, MI
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-… 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 table, including the 2017 guidelines for control of hyperphosphatemia, summarize the updated guidelines (Section 4.1) relevant to the measure topic presented here.
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 affect a reduction in mortality, and that avoidance of hypophosphatemia is prudent.
There is a small group of publications describing the pathophysiology and consequences of CKD-MBD in children along with the similarities and some important differences in presentation and treatment issues between children and adults. The pediatric literature, similar to adults, points to increased risk of bone fractures with elevated phosphorus and a decline in fracture risk with the use of phosphate binders. Vascular calcification has also been well described in pediatric population as well as the ensuing vascular stiffness.
Two major differences between the adult and pediatric CKD-MBK literature are evident. First, because of the very small number of pediatric dialysis patients in the United States (and elsewhere), as expected, the pediatric literature is lacking in both number and quality of observational and interventional studies compared to the adult literature. Second, there are numerous summary reviews that describe the specific differences related to growth physiology between children and older adults. Specifically, pediatric CKD patients have impaired growth/maturation of multiple organ systems, including musculoskeletal and neurological systems, resulting in specific concerns about provision of adequate nutrition and careful monitoring of these parameters in children. During the Pediatric Focus group discussions that UM-KECC convened in support of this measure, participants expressed concern that the 6-month average phosphorus was too long given the concern about the potential impact of CKD-MBD and its treatments on optimizing growth in the pediatric dialysis population targeted here.
Summary
There is 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. Although there is a paucity of high-quality randomized trials indicating that phosphorus reduction results in better patient outcomes, the existing literature supports this conclusion and has had consistent findings for several decades.
The literature from the pediatric population is consistent with the adult population for selected outcomes (fracture risk, accelerated cardiovascular disease) and we believe it is appropriate to extrapolate findings from the adult population since similar mechanisms in disease pathology are present, as are treatment options and interventions by the dialysis facility team.
Adult Literature References
1. Hamano T, Fukagawa M. Results of the EPISODE trial plead for reasonable practice-based serum phosphate lowering in patients on dialysis. Kidney Int. 2024;106(2):191-195. doi:10.1016/j.kint.2024.06.003
2. Murray SL, Wolf M. Calcium and Phosphate Disorders: Core Curriculum 2024. Am J Kidney Dis. 2024;83(2):241-256. doi:10.1053/j.ajkd.2023.04.017
3. Noordzij M, Korevaar JC, Boeschoten EW, Dekker FW, Bos WJ, Krediet RT. Hyperphosphataemia and related mortality. Nephrol Dial Transplant. 2006;21(9):2676-2677. doi:10.1093/ndt/gfl229
4. Kestenbaum B. Phosphorus binders in ESRD: consistent evidence from observational studies. Am J Kidney Dis. 2012;60(1):3-4. doi:10.1053/j.ajkd.2012.04.007
5. Waheed AA, Pedraza F, Lenz O, Isakova T. Phosphate control in end-stage renal disease: barriers and opportunities. Nephrol Dial Transplant. 2013;28(12):2961-2968. doi:10.1093/ndt/gft244
6. Doshi SM, Wish JB. Past, Present, and Future of Phosphate Management. Kidney Int Rep. 2022;7(4):688-698. Published 2022 Feb 1. doi:10.1016/j.ekir.2022.01.1055
7. Scialla JJ, Kendrick J, Uribarri J, et al. State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective. Am J Kidney Dis. 2021;77(1):132-141. doi:10.1053/j.ajkd.2020.05.025
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15. Young EW, Albert JM, Satayathum S, et al. Predictors and consequences of altered mineral metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 2005;67(3):1179-1187. doi:10.1111/j.1523-1755.2005.00185.x
16. Zitt E, Lamina C, Sturm G, et al. Interaction of time-varying albumin and phosphorus on mortality in incident dialysis patients. Clin J Am Soc Nephrol. 2011;6(11):2650-2656. doi:10.2215/CJN.03780411
17. Block GA, Kilpatrick RD, Lowe KA, Wang W, Danese MD. CKD-mineral and bone disorder and risk of death and cardiovascular hospitalization in patients on hemodialysis. Clin J Am Soc Nephrol. 2013;8(12):2132-2140. doi:10.2215/CJN.04260413
18. 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
19. Rivara MB, Ravel V, Kalantar-Zadeh K, et al. Uncorrected and Albumin-Corrected Calcium, Phosphorus, and Mortality in Patients Undergoing Maintenance Dialysis. J Am Soc Nephrol. 2015;26(7):1671-1681. doi:10.1681/ASN.2014050472
20. Zhang H, Li G, Yu X, et al. Progression of Vascular Calcification and Clinical Outcomes in Patients Receiving Maintenance Dialysis. JAMA Netw Open. 2023;6(5):e2310909. Published 2023 May 1. doi:10.1001/jamanetworkopen.2023.10909
21. Kim JE, Park J, Jang Y, et al. Oral phosphate binders and incident osteoporotic fracture in patients on dialysis. Nephrol Dial Transplant. Published online June 17, 2024. doi:10.1093/ndt/gfae139
22. Cannata-Andía JB, Rodríguez-García M. Hyperphosphataemia as a cardiovascular risk factor -- how to manage the problem. Nephrol Dial Transplant. 2002;17 Suppl 11:16-19. doi:10.1093/ndt/17.suppl_11.16
23. Gross P, Six I, Kamel S, Massy ZA. Vascular toxicity of phosphate in chronic kidney disease: beyond vascular calcification . Circ J. 2014;78(10):2339-2346. doi:10.1253/circj.cj-14-0735
24. Moe SM, Chertow GM, Parfrey PS, et al. Cinacalcet, Fibroblast Growth Factor-23, and Cardiovascular Disease in Hemodialysis: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial. Circulation. 2015;132(1):27-39. doi:10.1161/CIRCULATIONAHA.114.013876
25. Noori N, Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Kopple JD. Association of dietary phosphorus intake and phosphorus to protein ratio with mortality in hemodialysis patients. Clin J Am Soc Nephrol. 2010;5(4):683-692. doi:10.2215/CJN.08601209
26. Floege J. Phosphate binders in chronic kidney disease: an updated narrative review of recent data. J Nephrol. 2020;33(3):497-508. doi:10.1007/s40620-019-00689-w
27. FHN Trial Group, Chertow GM, Levin NW, et al. In-center hemodialysis six times per week versus three times per week [published correction appears in N Engl J Med. 2011 Jan 6;364(1):93]. N Engl J Med. 2010;363(24):2287-2300. doi:10.1056/NEJMoa1001593
28. Rocco MV, Lockridge RS Jr, Beck GJ, et al. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011;80(10):1080-1091. doi:10.1038/ki.2011.213
29. Schorr M, Manns BJ, Culleton B, et al. The effect of nocturnal and conventional hemodialysis on markers of nutritional status: results from a randomized trial. J Ren Nutr. 2011;21(3):271-276. doi:10.1053/j.jrn.2010.04.004
30. Ok E, Duman S, Asci G, et al. Comparison of 4- and 8-h dialysis sessions in thrice-weekly in-centre haemodialysis: a prospective, case-controlled study. Nephrol Dial Transplant. 2011;26(4):1287-1296. doi:10.1093/ndt/gfq724
31. Walsh M, Manns BJ, Klarenbach S, Tonelli M, Hemmelgarn B, Culleton B. The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial. Hemodial Int. 2010;14(2):174-181. doi:10.1111/j.1542-4758.2009.00418.x
32. Culleton BF, Walsh M, Klarenbach SW, et al. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007;298(11):1291-1299. doi:10.1001/jama.298.11.1291
33. Palmer SC, Gardner S, Tonelli M, et al. Phosphate-Binding Agents in Adults With CKD: A Network Meta-analysis of Randomized Trials [published correction appears in Am J Kidney Dis. 2017 Sep;70(3):452. doi: 10.1053/j.ajkd.2017.06.006]. Am J Kidney Dis. 2016;68(5):691-702. doi:10.1053/j.ajkd.2016.05.015
34. 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
35. 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
36. 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
37. 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
38. 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
39. 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
40. 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
41. 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
Pediatric Literature References
1. Lalayiannis AD, Soeiro EMD, Moys RMA, Shroff R. Chronic kidney disease mineral bone disorder in childhood and young adulthood: a 'growing' understanding. Pediatr Nephrol. 2023 Aug 25. doi: 10.1007/s00467-023-06109-3.
2. Jung J, Lee KH, Park E, Park YS, Kang HG, Ahn YH, Ha IS, Kim SH, Cho H, Han KH, Cho MH, Choi HJ, Lee JH, Shin JI. Mineral bone disorder in children with chronic kidney disease: Data from the KNOW-Ped CKD (Korean cohort study for outcome in patients with pediatric chronic kidney disease) study. Front Pediatr. 2023 Feb 17; 11:994979. doi: 10.3389/fped.2023.994979
3. Lalayiannis AD, Crabtree NJ, Ferro CJ, Wheeler DC, Duncan ND, Smith C, Popoola J, Varvara A, Mitsioni A, Kaur A, Sinha MD, Biassoni L, McGuirk SP, Mortensen KH, Milford DV, Long J, Leonard MD, Fewtrell M, Shroff R. Bone Mineral Density and Vascular Calcification in Children and Young Adults With CKD 4 to 5 or on Dialysis Kidney Int Rep. 2022 Nov 2;8(2):265-273. doi: 10.1016/j.ekir.2022.10.023. eCollection 2023 Feb.
4. Bakkaloglu SA, Bacchetta J, Lalayiannis AD, Leifheit-Nestler M, Stabouli S, Haarhaus M, Reusz G, Groothoff J, Schmitt CP, Evenepoel P, Shroff R, Haffner D; European Society for Paediatric Nephrology (ESPN) Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) and Dialysis working groups and CKD-MBD working group of the European Renal Association–European Dialysis and Transplant Association (ERA-EDTA). Bone evaluation in paediatric chronic kidney disease: clinical practice points from the European Society for Paediatric Nephrology CKD-MBD and Dialysis working groups and CKD-MBD working group of the ERA-EDTA. Nephrol Dial Transplant. 2021 Feb 20;36(3):413-425. doi: 10.1093/ndt/gfaa210. PMID: 33245331.
5. Kogon AJ, Harshman LA. Chronic Kidney Disease: Treatment of Comorbidities I: (Nutrition, Growth, Neurocognitive Function, and Mineral Bone Disease).Curr Treat Options Pediatr. 2019 Jun 15; 5:78-92. doi: 10.1007/s40746-019-00152-9. Epub 2019 Apr 15.
6. McAlister L, Pugh P, Greenbaum L, Haffner D, Rees L, Anderson C, Desloovere A, Nelms C, Oosterveld M, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Tuokkola J, Warady B, Walle JV, Shaw V, Shroff R. The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition TaskforcePediatr Nephrol. 2020 Mar; 35(3):501-518. doi: 10.1007/s00467-019-04370-z. Epub 2019 Oct 30.
7. Kakajiwala A, Jemielita TO, Copelovitch L, Leonard MB, Furth SL, York A, Benton M, Hoofnagle AN, Windt K, Merrigan K, Lederman A, Denburg MR. Variability in measures of mineral metabolism in children on hemodialysis: impact on clinical decision-making. Pediatr Nephrol. 2017 Dec; 32(12):2311-2318. doi: 10.1007/s00467-017-3730-4. Epub 2017 Jun 30.
8. Taylor JM, Oladitan L, Degnan A, Henderson S, Dai H, Warady BA. Psychosocial Factors That Create Barriers to Managing Serum Phosphorus Levels in Pediatric Dialysis Patients: A Retrospective Analysis J Ren Nutr. 2016 Jul; 26(4):270-5. doi: 10.1053/j.jrn.2016.02.003. Epub 2016 Mar 15.
9. Hahn D, Hodson EM, Craig JC. Interventions for metabolic bone disease in children with chronic kidney disease Cochrane Database Syst Rev. 2015 Nov 12; 2015(11):CD008327. doi: 10.1002/14651858.CD008327.pub2.
10. Denburg MR, Kumar J, Jemielita T, Brooks ER, Skversky A, Portale AA, Salusky IB, Warady BA, Furth SL, Leonard MB. Fracture Burden and Risk Factors in Childhood CKD: Results from the CKiD Cohort Study. J Am Soc Nephrol. 2016 Feb; 27(2):543-50. doi: 10.1681/ASN.2015020152. Epub 2015 Jul 2.
11. Srivaths PR, Goldstein SL, Silverstein DM, Krishnamurthy R, Brewer ED. Elevated FGF 23 and phosphorus are associated with coronary calcification in hemodialysis patients. Pediatr Nephrol. 2011 Jun; 26(6):945-51. doi: 10.1007/s00467-011-1822-0. Epub 2011 Feb 27.
12. Ahlenstiel T, Pape L, Ehrich JH, Kuhlmann MK. Self-adjustment of phosphate binder dose to meal phosphorus content improves management of hyperphosphataemia in children with chronic kidney disease. Nephrol Dial Transplant. 2010 Oct; 25(10):3241-9. doi: 10.1093/ndt/gfq161. Epub 2010 Mar 22.
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. 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 adult 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. In addition, as of January 2025, oral phosphate binder medications have been included in the bundle payment system, so that they are no longer separately billable under Part D for Medicare beneficiaries. As a result, dialysis facilities are now under increased financial pressure to provide effective phosphate binding medications in a cost-effective manner. The ability to measure chronic hyperphosphatemia will be critical to safeguard against the unintended consequences of having phosphate binders added into the bundled payment system.
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 7,540. The total number of patients included in the performance scores was 448,775. There is a significant performance gap: facilities in decile 1 (highest performing group) have only 7.8% of patient months with an elevated phosphorus above threshold compared to decile 10 facilities (lowest performing group) at 46.0% of patient months.
| 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% | 13.1% | 16.0% | 18.4% | 20.6% | 22.9% | 25.4% | 28.4% | 32.2% | 46.0% | 100% |
| N of Entities | 7,540 | 15 | 754 | 754 | 754 | 754 | 754 | 754 | 754 | 754 | 754 | 754 | 27 |
| N of Persons / Encounters / Episodes | 3,767,112 | 2,265 | 301,389 | 382,065 | 402,511 | 413,028 | 412,596 | 408,306 | 402,699 | 402,791 | 363,238 | 278,489 | 7,465 |
Care Gaps
Closing Care Gaps
This field is optional for Fall 2025.
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.
N/A
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.
EQRS - January 2021 to December 2022
None.
7,540 facilities with 10 or more eligible 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 448,775 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, 56.5% were white, 35.1% were black, 20.5% were Hispanic, and 45.9% had diabetes as primary cause of ESRD.
Reliability
Data element reliability: Data for this measure comes from the End Stage Renal Disease Quality Reporting System (EQRS), a CMS-owned data system that collects data directly from all Medicare-certified dialysis facilities. EQRS has processes in place [1] to ensure the reliability and validity of the patient level data used for a broad array of measure calculations, including this measure. Briefly, CMS performs a random selection of 300 eligible dialysis facilities each year. Ten patient records are randomly selected from a single quarter each year from each of the facilities selected to participate. Experienced nurse reviewers assessed the data obtained from the medical records on each of 24 data elements in EQRS, including the phosphorus value for the reported month and the date the phosphorus was collected in the reporting month.
1. Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. 88 FR 76344. 42 CFR 413 (2023), 42 CFR 512 (2023)
https://www.federalregister.gov/d/2023-23915 (accessed 10/22/2025)
Accountable entity level 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.
Data element reliability: Per the executive summary [1], the rate of correct matches was 96.5% for all data elements. 1.6% of entries in either EQRS (.2%) or Medical Records (1.4%) contained missing information. The rate of discrepant comparisons was 1.9%.
1. Executive Summary End Stage Renal Disease Quality Incentive Program Data Validation & Reliability (ESRD QIP DV&R) Clinical Performance Measures (CPMs) Project. Centers for Medicare and Medicaid Services, September 2023. https://qualitynet.cms.gov/files/654aaa312a222d001c16aa45?filename=2023… (accessed 10/22/2025)
Accountable entity reliability: the overall IUR is 0.77. See Table 2 for results by decile. Please note the IUR deciles were calculated based on the sample size within each facility and some facilities had the same values, so were grouped into the same decile. Due to this reason, deciles may not have a consistent distribution of facility counts.
Data element reliability: The estimated error rate of 1.9% obtained in this project is below the threshold of about 2.5% for achieving strong statistical power with the current sample size.
1. Executive Summary End Stage Renal Disease Quality Incentive Program Data Validation & Reliability (ESRD QIP DV&R) Clinical Performance Measures (CPMs) Project. Centers for Medicare and Medicaid Services, September 2023. https://qualitynet.cms.gov/files/654aaa312a222d001c16aa45?filename=2023…; (accessed 10/22/2025)
Accountable entity reliability: The overall IUR for the sample dataset was 0.77. The IUR’s per deciles of patients ranged from 0.47 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 | 0.766 | 0.355 | 0.474 | 0.586 | 0.649 | 0.693 | 0.728 | 0.757 | 0.782 | 0.810 | 0.838 | 0.883 | 0.951 |
| Mean Performance Score | 23.1% | 0% | 7.8% | 13.1% | 16.0% | 18.4% | 20.6% | 22.9% | 25.4% | 28.4% | 32.2% | 46.0% | 100% |
| N of Entities | 7,540 | 15 | 777 | 695 | 826 | 695 | 794 | 725 | 765 | 751 | 757 | 755 | 27 |
| N of Persons / Encounters / Episodes | 3,767,112 | 2,265 | 94,710 | 140,058 | 224,227 | 233,154 | 317,739 | 339,384 | 419,394 | 493,875 | 611,341 | 893,230 | 7,465 |
Validity
Data element validity: Data for this measure comes from the End Stage Renal Disease Quality Reporting System (EQRS), a CMS-owned data system that collects data directly from all Medicare-certified dialysis facilities. EQRS has processes in place [1] to ensure the reliability and validity of the patient level data used for a broad array of measure calculations, including this measure. Briefly, CMS performs a random selection of 300 eligible dialysis facilities each year. Ten patient records are randomly selected from a single quarter each year from each of the facilities selected to participate. Experienced nurse reviewers assessed the data obtained from the medical records on each of 24 data elements in EQRS, including the phosphorus value for the reported month and the date the phosphorus was collected in the reporting month.
1. Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. 88 FR 76344. 42 CFR 413 (2023), 42 CFR 512 (2023)
https://www.federalregister.gov/d/2023-23915 (accessed 10/22/2025)
Accountable entity level validity: We used January 2022 – December 2022 EQRS clinical data to assess facility level performance scores. 7,540 facilities with 10 or more patients were used for validity testing, which includes 448,755 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.
Data element validity: Per the executive summary [1], the rate of correct matches was 96.5% for all data elements. 1.6% of entries in either EQRS (.2%) or Medical Records (1.4%) contained missing information. The rate of discrepant comparisons was 1.9%.
1. Executive Summary End Stage Renal Disease Quality Incentive Program Data Validation & Reliability (ESRD QIP DV&R) Clinical Performance Measures (CPMs) Project. Centers for Medicare and Medicaid Services, September 2023. https://qualitynet.cms.gov/files/654aaa312a222d001c16aa45?filename=2023… (accessed 10/22/2025)
Accountable entity validity: see attached table.
Data element validity: The estimated error rate of 1.9% obtained in this project is below the threshold of about 2.5% for achieving strong statistical power with the current sample size.
1. Executive Summary End Stage Renal Disease Quality Incentive Program Data Validation & Reliability (ESRD QIP DV&R) Clinical Performance Measures (CPMs) Project. Centers for Medicare and Medicaid Services, September 2023. https://qualitynet.cms.gov/files/654aaa312a222d001c16aa45?filename=2023…; (accessed 10/22/2025)
Accountable entity validity: 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
Analyses that we conducted indicated that the disparities in hyperphosphatemia were not in the expected direction, with traditionally underserved populations performing better on the measure in patient level analyses and minimal impact in facility level analyses. This was discussed with our technical expert panel who unanimously agreed that the measure should not be risk adjusted.
Use & Usability
Use
Usability
There are two main actions that facilities can take to improve performance on this measure. First, regular dietary counseling on a nutrition plan that is low in phosphorus containing foods is considered the cornerstone for management of hyperphosphatemia. Since phosphorus content of most foods can be difficult to determine, a detailed assessment of patients eating habits and food choices by the dietician (required to be present at all Medicare-certified dialysis facilities) with feedback on low-phosphorus alternatives is critical. The second main action is the prescription of phosphorus binding medications. Regular assessment of the dose and adherence are key since the pill burden is often quite high and some of these medications have gastrointestinal side effects. Therefore it is not unusual to need to change phosphate binders or use combinations of different phosphate binders to achieve the desired outcome. Other actions that facilities can take would be more frequent measurement of serum phosphorus to provide rapid feedback to interventions. Optimizing the dose of dialysis may also help achieve improvement in phosphorus control. 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.
None are anticipated.
Comments
Staff Preliminary Assessment
CBE #5320 Staff Preliminary Assessment
Importance
Strengths
- A clear logic model is provided, depicting the relationships between inputs (e.g., clinical guidelines, quality improvement team, patient engagement resources), activities (e.g., regular measurement of serum phosphorus to identify patients with chronically elevated levels, the use of phosphate binding medications), and desired outcomes (e.g., increased awareness among patients of phosphorus control, reduction in percentage of patients with chronic hyperphosphatemia). This model demonstrates how the measure's implementation will lead to the anticipated outcomes.
The developer argued that, if implemented, the measure is expected to reduce adverse outcomes (such as cardiovascular complications, bone fracture risk, and mortality) based on the cited literature, including several observational studies.
Data from End Stage Renal Disease Quality Reporting System (EQRS) clinical files from 2021-2022 show a performance gap across 7,540 facilities, with decile ranges from 7.8% to 46% indicating variation in measure performance. The developer described a sufficient search process, and they did not identify any similar measures that address chronic hyperphosphatemia in dialysis patients.
Through empirical observational studies, the submission demonstrates evidence of negative outcomes (such as cardiovascular events and hospitalizations, cardiac mortality, and bone fractures) among dialysis patients with hyperphosphatemia.
There is no explicit mention of patients finding the measure valuable or meaningful, however, the literature cited by the developer demonstrates an increase in patient's quality of life, including for pediatric patients (e.g., reduced fracture risk), from improved phosphate control.
Limitations
- The developer acknowledged limitations in the pediatric literature and indicated that some evidence suggests an association between elevated phosphorus levels and increased bone fracture risk in pediatric patients, as well as a potential reduction in fracture risk among those treated with phosphate binders. The developer also stated that extrapolation from adult populations may be reasonable, given similarities in disease pathology, treatment options, and dialysis facility–based interventions.
An adult-only version of this measure is endorsed as CBE #4650. It is unclear if the proposed measure will replace the existing measure or if there are business cases to maintaining these measures separately.
Rationale
- This new measure meets all criteria for 'Met' for importance due to its significant anticipated impact, comprehensive evidence review, a documented performance gap, and well-articulated logic model, making it essential for addressing chronic hyperphosphatemia in dialysis patients.
There is at least moderate confidence that the business case is adequate, i.e., the anticipated impacts of the measure on patient outcomes justify use of the measure.
Closing Care Gaps
The developer did not address this optional domain.
Feasibility Assessment
Strengths
- All required data elements are routinely generated during care delivery and available from the End Stage Renal Disease Quality Reporting System (EQRS). The developer stated that no adjustments were made to the measure specifications due to their perceived high feasibility of the measure.
The developer described the costs and burden associated with data collection and data entry, validation, and analysis. They do not anticipate any additional costs or burden associated with data collection since all required data are routinely generated through care delivery.
The developer described how all required data elements can be collected without risk to patient confidentiality, specifically noting that facilities with less than 11 eligible patients do not participate in public reporting for this measure to mitigate potential identifiable information related to small cell size.
There are no fees, licensing, or other requirements to use any aspect of the measure (e.g., value/code set, risk model, programming code, algorithm).
Limitations
- None identified.
Rationale
- This new measure meets all criteria for 'Met' for feasibility due to its well-documented feasibility assessment, clear and implementable data collection strategy, and transparent handling of patient confidentiality, burden, licensing, and fees. These factors collectively ensure that the measure can be implemented effectively and sustainably in a real-world health care setting.
Scientific Acceptability
Strengths
- The developer performed the required reliability testing for this new measure, namely, they provided existing evidence (Executive Summary: ESRD QIP Data Validation & Reliability CPMs Project) of person/encounter-level (“data element”) reliability for all critical data elements.
The study cited by the developer shows 96.5% correct matches across 24 data elements sampled from 300 facilities. The lowest percentage of correct matches that impact this measure is 88.2%. This meets the expected threshold of 0.4 for inter-rater agreement.
Although not required for this new measure, the developer conducted accountable entity-level (“measure score”) reliability testing at the level for which the measure is specified. Data sources used for reliability analysis are adequately described and include EQRS clinical files for over 3.7M persons across 7,540 entities during the period of January 2022-December 2022.
The developer conducted signal-to-noise reliability testing at the accountable entity-level. More than 70% of accountable entities meet the expected threshold of 0.6 at all the level for which the measure is specified.
Limitations
- None identified.
Rationale
- This new measure is rated as ‘Met’ for reliability because the developer performed the required reliability testing for this measure and results demonstrate sufficient reliability at the person- or encounter-level.
Strengths
- The developer performed the required validity testing for this new measure, namely, they provided evidence of person/encounter-level (“data element”) validity testing for all critical data elements. Data sources used for validity analysis are adequately described and include registry data from the ESRD Quality Reporting System (EQRS) and administrative data sources during the period January 2021 to December 2022. There were 7,540 dialysis facilities having at least 10 eligible patients that provided care to a total of 448,775 patients during this period.
The developer described how data elements are validated by CMS. Ten patient records are randomly sampled from 300 dialysis facilities annually, and nurse abstractors collect data from medical records for critical data elements, including the phosphorus value and date the phosphorus was collected for testing. The developer reported an estimated error rate of 1.9%, which is below 2.5% threshold they cited as acceptable. These results suggest that the data elements used in the quality measure have sufficient accuracy.
While not required for a new measure, the developer conducted accountable entity-level (“measure score”) validity testing at the level for which the measure is specified. They performed Poisson regression of the measure score in quintiles (using the lowest quintile [Q1] as the reference) on two conceptually related outcome measures, the standardized mortality ratio (SMR) and the standardized hospitalization ratio (SHR). A lower hyperphosphatemia score is better, and the developer hypothesized positive relationships between the measure score and both SMR and SHR, as well as dose-response relationships where they predicted the SMR and SHR rates would increase as the measure score quintiles increased. The results support the hypotheses, with significant and increasing rate ratios relative to Q1 for both SMR (RRs: Q2, 1.03; Q3, 1.07; Q4, 1.09; Q5, 1.18) and SHR (RRs: Q2, 1.05; Q3, 1.04; Q4, 1.07; Q5, 1.13).
Limitations
- Limitations related to entity-level validity are the relatively few observational studies reporting on health care processes that influence the measure, and ungraded or low graded guidelines (see CBE 4650, 2.2 Evidence of Measure Importance for Kidney Disease: Improving Global Outcomes [KDIGO] guidelines for treatment of mineral and bone disease [MBD]). In addition, while their analysis did demonstrate a dose response of the measure with SHR and SMR, this submission would be strengthened by a discussion for why the relationship of the measure with SMR appears stronger (e.g., through the degree of overlap in constructs). Because entity-level validity testing is not required for new measures, these limitations do not affect the rating for validity.
The developer did not conduct risk adjustment, but provided the rationale that the results of risk adjustment analyses performed contradicted the conceptual model. The developer stated the decision not to perform risk adjustment was supported by a technical expert panel. The conceptual model and results of the analyses performed were not provided with the submission.
Rationale
- This new measure is rated as ‘Not Met But Addressable’ for validity because the validity testing results partially support an inference of validity for the measure, suggesting that the measure somewhat accurately reflects performance on quality and can distinguish good from poor performance.
Specifically, the developer did not conduct risk adjustment. The rationale provided lacks supportive evidence that differences in patient characteristics do not bias facility comparisons.
Use and Usability
Strengths
- The measure is not currently in use, but the developer described a plan for use in public reporting and payment programs.
The developer provided a summary of how accountable entities can use the measure results to improve performance. Specifically, entities can implement regular dietary counseling on a low-phosphorus nutrition plan, prescribe phosphorus binding medications, and optimize dialysis dosage to mitigate hyperphosphatemia. These possible actions are reflected in the measure’s logic model.
Limitations
- The submission could be strengthened with a discussion of how the developer concluded that no unintended consequences are anticipated (e.g., discussions with TEP, examining the cited literature).
Rationale
- This new measure is rated ‘Met' for use and usability there is a plan for use in at least one accountability application, and the measure provides actionable information for improvement. The developer reported that no potential unintended consequences were identified.
Committee Independent Review
Support
Importance
Comprehensive literature review and clear logic model. More high-quality evidence of clinically-appropriate thresholds would be valuable.
Closing Care Gaps
optional - not addressed
Feasibility Assessment
Feasibility established through use of existing, required data
Scientific Acceptability
No additional comments
would be helpful to have an expanded discussion of the testing results and the decision not to risk-adjust, beyond the finding that the results were not in the expected direction.
Use and Usability
Evidence would be enhanced by examples of specific interventions dialysis facilities have undertaken to better manage hyperphosphatemia, including addressing the challenges referenced in the write-up.
Summary
Overall comprehensive submission, with some opportunities to enhance the evidence in support of the numerator threshold and usability.
See comments in the above…
Importance
Agree with staff assessment
Closing Care Gaps
Agree with staff assessment
Feasibility Assessment
Agree with staff assessment
Scientific Acceptability
Agree with staff review
Agree with staff assessment
Use and Usability
Agree with the staff assessment but also would appreciate feedback from the developer regarding ASN comments of increasing the threshold and adjusting the exclusion criteria.
Summary
See comments in the above fields
No additional comments
Importance
No additional comments, agree with staff review
Closing Care Gaps
No additional comments, agree with staff review
Feasibility Assessment
No additional comments, agree with staff review
Scientific Acceptability
No additional comments, agree with staff review
No additional comments, agree with staff review
Use and Usability
No additional comments, agree with staff review
Summary
No additional comments, agree with staff review
5320 Summary
Importance
As noted in the staff review, most of the criteria for importance are met (strong logic model, extensive review of the literature). However, the measure developers, staff and ASN note the drawbacks of relying on primarily observational data to support the impact of hyperphosphatemia lowering interventions on targeted outcomes. In addition the advisory committee asked about the lack of studies to support specific phosphorus levels for adult and pediatric populations in the measure. Both of these issues need to be addressed during discussion along with the importance of this measure in countering payment incentives to reduce use of phosphate binders.
Closing Care Gaps
Optional
Feasibility Assessment
agree with staff assessment. Wondered if the differences in timeframes and phosphorus levels between adult and pediatric population created any issues for facilities
Scientific Acceptability
signal to noise ratio within acceptable level - ask measure developer to explain why this measure met acceptable level while other measures under review did not. The explanation provided was related to small facility size - wouldn't this be the case here too?
Criterion validity measures were in expected direction and differed from first to fifth quintile. Need to explain staff rationale for not met but addressable.
Rationale for not risk adjusting interesting - why do measure developers think underserved populations performed better on this measure?
Use and Usability
New combined adult and pediatric measure - plan to use in public reporting and payment incentive programs. Will previous adult measure be discontinued?
Summary
Rationale for importance well documented; issue of relying primarily on observational studies noted by measure developers, advisory group, staff and public comments - should be discussed. Seems to be a complex measure with different parameters for adults and pediatric population - does this raise any feasibility issues? Rationale for lack of risk adjustment interesting - reason for better performance in underserved populations?
Patient Partner review of 5320 Hyperphosphatemia
Importance
I agree with the staff assessment
Closing Care Gaps
Not required
Feasibility Assessment
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.
Scientific Acceptability
As a patient partner, I am not a technical expert in this area. As such, I agree with the staff assessment.
As a patient partner, I am not a technical expert in this area. As such, I agree with the staff assessment.
Use and Usability
Not in use – new measure. I agree with the staff assessment.
Summary
A discussion of the American Society of Nephrology public comments is appreciated.
(Support endorsement
Importance
Agree with staff assessment.
Excellent logic model. Especially appreciate the attention in the logic model to patient level factors (mostly SDoH) accounted for in the logic model.
The measure would provide CMS, payers and public with strong information about quality of dialysis centers.
Closing Care Gaps
Not addressed by developer.
Feasibility Assessment
Agree with staff assessment. Data required to calculate the measure are already collected and used, so does not involve additional burden.
Scientific Acceptability
Agree with staff analysis and assessment.
ostly agree with staff assessment. I am not as concerned about the relatively few observational studies reporting on health care processes that influence the measure. The logic model suggests a wide variety of circumstances which may contribute to hyperphosphatemia. Like many other outcome measures, the endorsement and use of this measure may catalyze more study of contributing factors and identify prociesses which influences the measure.
Would have liked to see more discussion about the decision not to risk adjust. The finding that traditionally underserved populations perform better on the measure in patient level analyses is intriguing and could be explored more.
Use and Usability
Agree with staff assessment.
I would like more information about how endorsement of this measure relates to CBE#4650, which was just endorsed last year. It seems like the difference between the two is that CBE#4650 applies to adult populations only, while this measure applies to adults and children one year or older. Is it proposed that this measure would replace CBE #4650 if it is endorsed?
Summary
I support endorsement of this measure. The logic model is excellent and clearly describes how this measure can improve dialysis center quality and improve health and quality of life for people receiving dialysis.
(No subject)
Importance
Agree with the staff assessment.
Closing Care Gaps
Not required.
Feasibility Assessment
Agree with staff assessment.
Scientific Acceptability
Agree with staff assessment.
Agree with staff assessment.
Use and Usability
Agree with the staff assessment.
Summary
I appreciated the comments from the American Nephrology Society.
Support with one condition
Importance
I would like the developer to consider adding to measure. The type of binder used makes a real difference for those at risk for hyperphosphatemia.
My experience is that when I was dialyzing, there was some misinformation even from dialysis techs that Tums was a viable alternative. Binders are usually low cost and to substitute Tums for the prescription is wrong. In addition, not all binders are created equal, even the prescription binders.
Closing Care Gaps
-
Feasibility Assessment
-
Scientific Acceptability
-
I recommend that the developer consider doing research to assess risk assessment by race and sex. The literature and clinical evidence is that the potential for hyperphosphatemia will vary on these characteristics.
Use and Usability
-
Summary
-
Await committee discussion
Importance
The measure could important for making significant gains in health care quality or cost where there is variation in or overall less-than-optimal performance.
Closing Care Gaps
Not addressed
Feasibility Assessment
Data are readily available OR could be captured without undue burden AND can be implemented for performance measurement.
Scientific Acceptability
The measure, as specified, produces consistent (reliable) results about the quality of care
The measure, as specified, might produce credible (valid) results about the quality of care
Use and Usability
Measure results might be used for both accountability and performance improvement to achieve the goal of high-quality efficient health care for individuals or populations. Issues of scientific and clinical validity and unintended consequences need to be addressed.
Summary
Measure results might be used for both accountability and performance improvement to achieve the goal of high-quality efficient health care for individuals or populations. Issues of scientific and clinical validity and unintended consequences need to be addressed.
Summary for #5320
Importance
This is identified as an intermediate outcome, which is appropriate. The logic model is sufficient and there appears to be care gap. The developers provide sufficient detail about the problem of ESKD MBD and rational for development of the metric (aligns with KDIGO consensus statement). While the causal mechanisms are defined, the evidence is limited to observational studies.
Closing Care Gaps
Not addresses
Feasibility Assessment
data needed for this metric are structured and standardized; no additional burden for facilities
Scientific Acceptability
defer to staff prelim assessment
defer to staff prelim assessment
Use and Usability
This is a new metric so not currently in use.
Per the logic model, there would be actions for facilities to take if performance was not meeting benchmarks.
Summary
This seems like a reasonable metric but my hesitancy to endorse is based on the position of the ANS. Not only are they experts in the field, but all of their comments to the other dialysis related metrics this cycle have been thoughtful and appropriate. I look forward to this discussion
Overall, while I understand…
Importance
I understand the importance of this measure and good intent.
Closing Care Gaps
There is significant concern about this measure's ability to close care gaps, as patients may not be able to afford phosphate binders, which directly relates to the value being measured. I think there can be cost-associated measure attached to the measure whether patients could afford the medications and obtain them.
Feasibility Assessment
Not support
Scientific Acceptability
Support
Support
Use and Usability
Not support
Summary
Overall, while I understand the intent, I am hesitant to accept as a measure that focuses on a single value, not a range.
Public Comments
ASN Comments on Percentage of Chronic Hyperphosphatemia
ASN has significant concerns with this measure. While we recognize that including phosphate-lowering medications in the prospective payment system may justify a quality measure to guide appropriate use, we are concerned that the proposed metric relies solely on observational data rather than robust clinical trial-based evidence and will not improve clinical outcomes. For example, no published clinical trials have established a serum phosphate range associated with improved outcomes, and neither the proposed threshold nor the hypoalbuminemia exception present in the measure is supported by high-quality data. In clinical practice, there are patients who have elevated phosphate levels above 6.5 mg/dL for periods of time, which reflect improvements in dietary intake that should not be discouraged as a result of this type of measure. Given the lack of supporting evidence, at a minimum we encourage CMS to consider a higher threshold and exclusion criteria for patients with established nutritional challenges