The ESRD Quality Incentive Program Can We Bridge the Chasm?

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1 The ESRD Quality Incentive Program Can We Bridge the Chasm? Daniel Weiner* and Suzanne Watnick *Department of Medicine, Tufts University, Medford, Massachusetts; Department of Medicine, Oregon Health and Science University, Portland, Oregon; and Division of Hospital and Specialty Care, Veterans Affairs Portland Health Care System, Portland, Oregon ABSTRACT The ESRD Quality Incentive Program (QIP) is the first mandatory federal pay for performance program launched on January 1, The QIP is tied to the ESRD prospective payment system and mandated by the Medicare Improvements for Patients and Providers Act of 2008, which directed the Centers for Medicare and Medicaid Services to expand the payment bundle for renal dialysis services and legislated that payment be tied to quality measures. The QIP links 2% of the payment that a dialysis facility receives for Medicare patients on dialysis to the facility s performance on quality of care measures. Quality measures are evaluated annually for inclusion on the basis of importance, validity, and performance gap. Other quality assessment programs overlap with the QIP; all have substantial effects on provision of care as clinicians, patients, regulators, and dialysis organizations scramble to keep up with the frequent release of wide-ranging regulations. In this review, we provide an overview of quality assessment and quality measures, focusing on the ESRD QIP, its effect on care, and its potential future directions. We conclude that a patient-centered, individualized, and parsimonious approach to quality assessment needs to be maintained to allow the nephrology community to further bridge the quality chasm in dialysis care. J Am Soc Nephrol 28: , doi: In 2001, the Institute of Medicine published their paradigm for the future of health care provision in the United States titled Crossing the Quality Chasm: A New Health System for the 21st Century. 1 A central tenet of this report was that payment and quality should be aligned. The Committee on Quality of Health Care in America, charged with developing this report, called on payers to remove barriers impeding quality improvement and incorporate stronger incentives for quality enhancement. They specifically stated that [c]linicians should be adequately compensated for taking good care of all types of patients, neither gaining nor losing financially for caring for sicker patients or those with more complicated conditions and that [p]ayment methods also should provide an opportunity for providers to share in the benefits of quality improvement, provide an opportunity for consumers and purchasers to recognize quality differences in health care and direct their decisions accordingly, align financial incentives with the implementation of care processes based on best practices and the achievement of better patient outcomes, and enable providers to coordinate care for patients across settings and over time. 1 Since then, these statements regarding reasonable clinician incentives for patientcentered approaches have guided health care policy, including provision of ESRD care, in the United States. Recognizing high costs and suboptimal outcomes, in February of 2008, the Secretary of Health and Human Services reported to Congress on a design for a bundled ESRD prospective payment system (PPS). 2 Elements of this report, which became law with the passage of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), 3 directed the Centers for Medicare and Medicaid Services (CMS) to expand the payment bundle for renal dialysis services to include drugs, laboratory services, and other commonly furnished items for which providers were receiving separate payment under Medicare Part B; this PPS began on January 1, Additionally, the MIPPA legislated that payment would be linked to quality measures. 3 On January 1, 2012, the first ever mandatory federal pay for performance program was launched: the ESRD Quality Incentive Program (QIP). 4 The QIP has substantially expanded since introduction, with the progressively increasing number of measures and lack of parsimony threatening true quality improvement activities that focus on the most important patient-centered aspects of quality care. Published online ahead of print. Publication date available at. Correspondence: Dr. Suzanne Watnick, 700 Broadway, Seattle, WA suzanne.watnick@ nwkidney.org Copyright 2017 by the American Society of Nephrology J Am Soc Nephrol 28: , 2017 ISSN : /

2 DEFINING QUALITY To place the QIP into context, quality must be defined. Within medicine, this is a difficult task, particularly when the heterogeneity of patient characteristics and goals is considered. One definition describes quality as the right care for the right patient at the right time. 5 Alternatively, the Institute of Medicine defined quality as [t]he degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. 1 To assess and compare quality, this somewhat abstract concept needs to become quantifiable. As described by Donabedian, 6,7 tools to quantify quality can include measures of structure, process, and outcomes, with the first two items serving as surrogates for the third (Table 1). Notably, Donabedian 6,7 struggled to balance individualization of care with hard and readily measurable outcomes, like all-cause mortality, stating that [o]ur criteria and standards need to be more flexibly adaptable to the finer clinical peculiarities of each case. In particular, we need to learn how to accurately elicit the preferences of patients to arrive at truly individualized assessments of quality. 7 Both the approach to quality by Donabedian 6,7 and the inherent conflict that he eloquently described nearly 30 years ago largely persist within current quality assessment programs, including the ESRD QIP. THE ESRD QIP The ESRD QIP is near synonymous with value-based purchasing (VBP). The goal of a VBP program is to produce quality health care that is both patient centered and outcome oriented. Notably, the QIP is not an incentive program in the true sense; rather, it is a penalty program, linking 2% of the payment that a dialysis facility receives for Medicare patients on dialysis to the facility s performance on quality of care measures. Therefore, the QIP is slightly cost saving for Medicare, because there is no bonus for achieving high performance scores, with the QIP reducing payments for failure to meet or exceed prespecified performance thresholds. The majority of facilities receive no penalty, and very few have received a full 2% penalty. This potential payment reduction is applied post hoc, withthecalendar year on which performance is measured preceding the payment year (PY) affected by 2 years. To promote transparency and potentially, informed decision making by health care consumers, facilities are required to publicly post QIP scores, and the CMS publicly reports facility QIP scores. An initial goal of the QIP was to ensure adequate resource utilization. With the implementation of the expanded bundle, the incentive for utilization of expensive previously separately billable interventions, such as erythropoiesis stimulating agents (ESAs), was replaced by a powerful financial incentive to underuse ESAs. The inclusion of a potential financial penalty in the QIP that would correlate with underutilization of ESAs provided some disincentive to underuse ESAs. The Table 1. The categorizations of Donabedian 6,7 of quality of medical care applied to dialysis Category and Description Structure The attributes of the settings in which care occurs Material resources (such as dialysis facilities and equipment and available capital) Human resources (such as the number and qualifications of center personnel) Organizational structure (such as medical staff organization, methods of peer review, and methods of reimbursement) Potential Dialysis Examples Staffing ratios Frequency of physician and provider encounters with patients Water quality measures Technician certification Process What is actually done in delivering and receiving care Patients activities in seeking care and carrying out care Providers activities in making diagnoses and recommending or implementing treatments Outcome The effects of care on the health status of patients and populations Improvements in patients knowledge Salutary changes in patients behavior Degree of patients satisfaction with care recovery, restoration of function, and survival QIP process measures, such as influenza vaccination, hemoglobin and phosphorus measurement, and depression and pain assessment Stable and unstable care plan completion Advance care planning documentation Successful patient on dialysis teach back Reduction in intradialytic weight gain ICH CAHPS results Mortality and hospitalization rates Health-related quality of life Age-appropriate employment status ICH CAHPS, In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems. Modified from references 6 and 7, with permission Journal of the American Society of Nephrology J Am Soc Nephrol 28: , 2017

3 BRIEF REVIEW dialysis adequacy metric has a similar effect, providing a disincentive to cut dialysis session duration. 8,9 Since the implementation of the expanded bundle and the QIP, mortality among patients on dialysis has improved. This trend preceded these programs, 10 and given the limited measures used in the first several years of the QIP, these improvements likely are unrelated to the QIP. The ESRD QIP has evolved. The number of measures increased from three at its inception in 2012 to 19 (including combined measures) for PY 2020, covering a broader range of topics and raising the question of whether the QIP has been diluted by the presence of too many metrics (Table 2), thereby failing to develop the parsimonious core group of measures that is the goal of VBP. On the basis of the MIPPA, the QIP must include measures on anemia management and dialysis adequacy. The MIPPA also charged the Secretary of Health and Human Services with including measures on patient satisfaction, iron management, bone and mineral metabolism and vascular access, to the extent feasible. In 2014, the Protecting Access to Medicare Act further required that the ESRD QIP include outcomes-based measures,alsototheextentfeasible, that are specific to the conditions treated with oral-only drugs. These legislative mandates account for many of the clinically oriented metrics in the current QIP, including the hypercalcemia measure, although the mandates do not prevent the CMS from removing a topped out measure from the QIP. Beginning in 2016, the QIP was divided into somewhat artificial domains to better align with the CMS s qualitystrategy (Table 3). QUALITY MEASURES A good quality measure has several characteristics falling into specific, measurable, achievable, relevant, and timely. 11 These characteristics result in a measure that can validly quantify the desired process or outcome and is comparable either within a center to allow for local quality improvement activities or between centers to allow valid ranking of performance. 12 Additionally, well conceived measures address domains where there is both room for improvement and reachable targets, recognizing that too much of a stretch goal may not warrant the effort needed, whereas a topped out measure may have little meaning and adversely affect individualization of care. To create valid quality measures, the CMS usually uses a measure development process that was reinforced in the Patient Protection and Affordable Care Act (PPACA). 13 This process, summarized in Figure 1, incorporates stakeholder input, a technical measure specification process, measurement testing for validity and feasibility, a public comment period, and typically, endorsement by an independent entity, including stakeholders, as required in Section 3014(b) of the PPACA. The CMS currently contracts with the National Quality Forum (NQF) to evaluate and endorse quality metrics through a process called the Measure Applications Partnership. 14 Interestingly, nine of the 13 measures in the PY 2018 QIP that will be continued in 2020 either were not NQF endorsed when initially included in the QIPor were not being applied in the same manner as the NQF-endorsed version as of the November of 2016 publication of the final rule. The standardized transfusion ratio received the NQF endorsement in December of 2016 after its inclusion in the QIP, whereas a bloodstream infection measure is endorsed, but the specifications used by the CMS substantially differ from the endorsed measure. The phosphorus reporting measure has only slight differences from the NQF-endorsed measure, whereas the depression screening measure is adapted from a measure used in other populations. Updated fistula and catheter measures that attempt to account for clinical characteristics and exclude patients with very limited life expectancy have been endorsed by the NQF; although these will likely replace the current vascular access measures, this has not yet occurred. The hypercalcemia measure was reendorsed with a reserve status, with the NQF expressing reservations about this metric given the poor evidence base and lack of performance gap; however, the measure was included due to the lack of other measures addressing mineral metabolism. We view inclusion of a poor measure in the QIP (because there are no other measures developed) as counter to the intent of the QIP and lacking patient centeredness. Of newly included measures, the standardized hospitalization ratio measure was reendorsed by the NQF in December of 2016, and the ultrafiltration rate measure is similar to but has important differences with a recently endorsed measure. 15 The QIP is fluid, with frequent addition of new quality measures. Added measures tend to fall into several categories: assessing a domain where limited measures exist, meeting a legal requirement or CMS-identified priority area,or in thecaseofreporting measures, developing baseline data sufficient to convert a reporting measure into a clinical measure. Ultimately, this transition from a reporting to a clinically oriented measure would fulfill the criteria for a true VBP process. Measures also can be removed from the QIP, and several have since program inception, including both anemia performance measures. Critical areas remain unaddressed, including difficult to quantify patientcentered topics like health-related quality of life, end of life and advance care planning, and patient engagement in their medical care. 16,17 Aonesizefits all approach will not achieve patientcentered goals and must be avoided as we move forward. For example, patients receiving palliative dialysis should be excluded from the ESRD QIP while being subject to measures relevant to end of life care. Using measures that are not yet endorsed and forcing measures, like hypercalcemia, into the system to satisfy a need for measures rather than reflecting the importance of a measure represent weaknesses in this system. Unfortunately, few endorsed measures exist that are robust, encourage parsimony, are patient centered and J Am Soc Nephrol 28: , 2017 The ESRD Quality Incentive Program 1699

4 Table 2. Evolution of the QIP: Measure Details PY 2012 PY 2013 PY 2014 PY 2015 PY 2016 PY 2017 PY 2018 PY 2019 PY 2020 Outcome/clinical measures Process/reporting measures URR adequacy URR adequacy URR adequacy Kt/V adequacy Kt/V adequacy Kt/V adequacy Kt/V adequacy Kt/V adequacy Kt/V adequacy Hb,10 g/dl Hb.12 g/dl Hb.12 g/dl Hb.12 g/dl Hb.12 g/dl VAT VAT VAT VAT Hb.12 g/dl VAT VAT VAT NHSN BSI NHSN BSI NHSN BSI NHSN BSI NHSN BSI SRR SRR SRR SRR Hypercalcemia Hypercalcemia Hypercalcemia Hypercalcemia Hypercalcemia ICH CAHPS a STrR STrR STrR ICH CAHPS a ICH CAHPS a SHR None None NHSN infection NHSN infection ICH CAHPS a ICH CAHPS a Mineral ICH CAHPS a ICH CAHPS a Mineral metabolism Mineral metabolism Mineral metabolism Mineral metabolism Mineral metabolism Anemia Anemia Anemia Mineral metabolism metabolism Anemia Anemia Pain a Pain a Pain a Anemia Depression a Depression a Depression a Measure weight Clinical/safety domain, % NHSN HCP NHSN HCP NHSN HCP UFR Reporting domain, % Minimum total 26 (of 30) 30 (of 30) 53 (of 100) 60 (of 100) 54 (of 100) 60 (of 100) 49 (of 100) 60 (of 100) Pending performance score URR target is $65%. VAT is a combined measure including both a fistula and a catheter measure. The NHSN Dialysis Event Reporting Measure transitioned to the NHSN BSI Clinical Measure for PY 2016 and refers to a Centers for Disease Control and Prevention initiative to first record and then benchmark dialysis-related bloodstream infections. For PY 2020, this is a combined reporting and performance measure. The NHSN HCP refers to health care personnel influenza vaccination. The ICH CAHPS assessing patient experience was administered annually by a third party vendor to patients on hemodialysis from calendar year 2012 to 2015 and twice annually thereafter. The mineral metabolism reporting measure initially required monthly reporting of calcium and phosphorus levels followed by phosphorus only in PY 2016, when calcium level became a clinical measure;the name was changed to serum phosphorus reporting measure, incorporating either serum or plasma phosphorus levels for PY Kt/V adequacy is a combined measure including adult hemodialysis, adult peritoneal dialysis, pediatric hemodialysis, and beginning in PY 2018, pediatric peritoneal dialysis measures. The anemia reporting measure reflects reporting monthly ESA dosage (as applicable) and hemoglobin/hematocrit for each Medicare patient. SRR evaluates readmissions within 30 days of an index discharge among patients on prevalent dialysis. STrR evaluates transfusion events, regardless of where the transfusion occurs. SHR compares the number of risk-adjusted observed hospitalizations with the number of expected hospitalizations. Pain and depression reporting measures refer to both screening for these and documenting a treatment plan. For each PY, the calendar year for patient data is 2 years earlier. URR, urea reduction ratio; Hb, hemoglobin; VAT, vascular access type; SRR, standardized readmission ratio; STrR, standardized transfusion ratio; ICH CAHPS, In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems; SHR, standardized hospitalization ratio; HCP, health care personnel influenza vaccination; UFR, ultrafiltration rate. a Measures that may be considered patientcentric Journal of the American Society of Nephrology J Am Soc Nephrol 28: , 2017

5 BRIEF REVIEW Table 3. The CMS quality strategy and QIP alignment with this strategy for calendar year 2016 (PY 2018) and beyond Subdomain QIP Domain Weighting, % National Quality Strategy Goal Clinical care 50 Promote the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease Patient and family engagement 30 Ensure that each person and each family are engaged as partners in their care Care coordination a Promote effective communication and coordination of care Safety 20 Make care safer by reducing harm caused in the delivery of care Community engagement N/A Work with communities to promote wide use of best practices to enable healthy living Cost N/A Make quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models Assigned Measures Measure Weight, % Kt/V dialysis adequacy 18 Vascular access type 18 Standardized transfusion 7 ratio Hypercalcemia 7 ICH CAHPS 20 Standardized readmission 10 ratio NHSN BSI 20 NHSN health care N/A personnel influenza vaccination reporting b None ICH CAHPS, In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems; N/A, not available. a The National Strategy for Quality Improvement in Health Care separates care coordination and patient and family engagement/patient centeredness into two subdomains; these are combined in the ESRD program. b Reporting measure; this does not affect the clinical score for QIP performance. Reporting measures account for 10% of the QIP, whereas the weights above are reweighted to account for 90% of the QIP performance score. None individualizable, and are feasible, clearly signaling the need for further measure development by stakeholders in the field using transparency, collaboration, and consistency as a guiding principles. 12 QIP SCORING In the final rule for 2015, the CMS wrote that they believe it is appropriate for benchmarks to increase, in line with improvements in national performance rates, because not increasing the benchmarks would hold facilities to a lower standard of care and would diminish incentives for improvement. 18 Recognizing that this statement defines the CMS s philosophy is critical to understanding both the QIP and the Five-Star Public Reporting Program in ESRD. A strength of this approach is that a facility is continuously pushed to perform better on quality metrics. Weaknesses are inherent in the metrics themselves, because this scoring strategy financially reinforces that higher performance on the selected metrics is better for all patients, resurrecting concerns initially noted by Donabedian with quantifying quality. To account for this weakness, there needs to be either a robust and clinically relevant strategy for declaring a measure topped out or adequate accounting for individual patient needs incorporated into measure specification. An example, included in the newly endorsed fistula measure, is the exclusion of patients on hemodialysis receiving hospice care from the fistula measure. 19 Other situations, such as how patients who have exhausted vascular access options are evaluated, have not been incorporated. In the QIP, for any given performance year, three thresholds are established an achievement threshold, a performance standard, and a benchmark, which represent the 15th, 50th, and 90th percentiles, respectively. Because the CMS believes that the ESRD QIP should not have lower performance standards than in previous years, these thresholds typically only rise over time. To illustrate scoring, for the vascular access type (percentage fistula) measure, the performance standard values for PY 2019 are 53.66%, 65.93%, and 79.62%, respectively. On the basis of these thresholds, a facility with 80% fistulas would get the maximum of ten points on this measure, because it exceeds the benchmark, whereas a facility with 50% fistulas would get zero points, because it falls below the achievement threshold. A facility with 70% fistulas would get six points. In addition, there is opportunity for obtaining points for improvement when a facility s performance increases significantly from the prior year. The overall scoring system is such that facilities exceeding the performance standard on all QIP measures will not incur a penalty. J Am Soc Nephrol 28: , 2017 The ESRD Quality Incentive Program 1701

6 Figure 1. The lifecycle of a quality measure. 34 HHS, Health and Human Services; TEP, Technical Expert Panel. MEASURE MAINTENANCE AND REMOVAL FROM THE QIP Onthebasisofthecurrentparadigm, facility performance rates needed to succeed on quality measures will, on average, continue to rise each year. Ultimately, this can introduce unintended consequences, because individualization of care conflicts with progressively rising achievement thresholds and benchmarks. Results could become no longer clinically meaningful and would move away from a patient-centered approach. For example, the Kt/Vadequacy measure is not appropriate if applied to a patient receiving palliative dialysis care or incremental hemodialysis in a setting of residual kidney function. 19,20 The current fistula measure could harm patients who have exhausted hemodialysis access options or elderly patients who are poor candidates for arteriovenous fistulas by incentivizing inappropriate procedures. 21 Unless a facility is sufficiently large or sufficiently successful on other metrics to absorb these patients into their overall QIP score, there will be either pressure to implement care practices that may not be appropriatefortheindividualpatientor reluctance to accept a patient into a facility. The hypercalcemia metric provides a good example. In a 40-patient facility, just one patient with persistent modest hypercalcemia can result in a QIP penalty. If this patient has side effects from attempts at lowering serum calcium, the facility is faced with either forcing such a treatmentonapatientorsubstantially increasing their risk for a QIP penalty. Recognizing this, the CMS describes scenarios in which a quality measure should be removed or replaced, and the 2015 ESRD PPS final rule adopted criteria for determining whether a clinical measure was topped out (Table 4). After reviewing existing measures, the CMS noted in the 2014 final rule that hemoglobin level above 12 g/dl had met these criteria; accordingly, this measure was removed for PY Of note, when comparing nearly 6000 dialysis facilities, quantitative thresholds for removal are unlikely to be met even when performance is isolated within a small range. OTHER DIALYSIS QUALITY ASSESSMENT PROGRAMS Multiple federal programs assess and report quality in dialysis. Addressing the goals of the Triple Aim and the principles delineated in the PPACA and emphasized in the Medicare Access and Children s Health Insurance Program (CHIP) Reauthorization Act of 2015 (MACRA), the CMS continues to expand quality measures, increase public reporting initiatives, and promote easily understandable formats. In addition to the QIP, dialysis facility level quality assessment programs include Dialysis Facility Compare Star Ratings. Other systems will apply to organizations, like the metrics used to evaluate ESRD Seamless Care Organizations (ESCOs) and additional alternative payment models (APMs) that may be developed. More recently, these principles were extended to individual physicians and physician practice groups in the Quality Payment Program (QPP) that emerged from the MACRA legislation in the form of the Merit-Based Incentive Payment System (MIPS). The MIPS likely will tie physician reimbursement to performance on many of the same quality metrics in the QIP that target dialysis facilities. The Dialysis Facility Compare Star Program was announced in June of 2014 by the CMS and launched in January of 2015 with the purpose of presenting differences 1702 Journal of the American Society of Nephrology J Am Soc Nephrol 28: , 2017

7 BRIEF REVIEW Table 4. Criteria for measure removal from the QIP Qualitative criteria Performance among majority of ESRD facilities is so high and unvarying that meaningful distinctions cannot be made Performance or improvement on measure does not result in better or intended patient outcomes Measure no longer aligns with current clinical guidelines or practice A better measure is available Collection or public reporting of measure leads to negative unintended consequences Quantitative criteria 75th (25th) Percentile is statistically indistinguishable from 90th (10th) percentile defined by these percentiles being within two SEMs of each other The truncated coefficient of variation is #0.10 An exception exists allowing topped out measures to remain in the QIP if addressing the unique needs of a specific subset of the ESRD population. On the basis of the quantitative criteria, no measures were eligible for removal for the 2020 QIP. in quality of care among dialysis facilities to inform patient choice by ranking facilities on a one- to five-star scale. The star rating is on the basis of nine publicly reported quality measures in 2015, partially overlapping the QIP (Table 5). 22,23 In the star rating system, each facility receives a rating between one and five stars on the basis of performance on these nine measures. In 2015, there was a forced normal distribution, such that 10% of facilities received one star, 20% received two stars, 40% received three stars, 20% received four stars, and 10% received five stars. This ranking system scaled to the curve, mandating that some facilities must have a low star ranking. Given that estimate precision was not accounted for (unlike other public reporting within dialysis facilities where performance is described as worse than expected, as expected, and better than expected on the basis of the 95% confidence interval), random variability will have significant effects on the number of stars awarded. There were widespread concerns regarding the five-star system when it Table 5. Dialysis Facility Compare Star Rating versus QIP PY 2018 measures Quality Measures QIP PY 2018 Reporting Year 2016 Dialysis Facility Compare Measure NQF No. Percentage of patients who had enough wastes Yes Yes 0249 removed from blood during dialysis: adult patients on hemodialysis Percentage of above for: pediatric patients on Yes Yes 1423 hemodialysis Percentage of above for: adult patients on Yes Yes 0318 peritoneal dialysis Percentage of adult patients on dialysis who had Yes Yes 1454 hypercalcemia Percentage of adult patients on dialysis receiving Yes Yes 0257 treatment through AVF Percentage of adult patients with catheter in vein Yes Yes d Standardized transfusion ratio Yes a Yes 2979 Standardized readmission ratio Yes No 2496 Bloodstream infection in outpatients on Yes No 1460 hemodialysis CAHPS in-center hemodialysis survey Yes a No 0258 Pediatric peritoneal dialysis adequacy: Yes a No 2706 achievement of target Kt/V Health care personnel influenza vaccine Yes a No 0431 Depression screening and follow-up Yes a No 0418 Pain assessment and follow-up Yes a No 0420 Anemia reporting Yes No Mineral metabolism reporting Yes No Standardized mortality ratio No Yes 0369 Standardized hospitalization ratio No Yes 1463 AVF, arteriovenous fistula; CAHPS, Consumer Assessment of Healthcare Providers. New measures in the QIP for PY J Am Soc Nephrol 28: , 2017 The ESRD Quality Incentive Program 1703

8 was released. The dialysis community stressed that this was a ranking system rather than a rating system, whereas the Medicare Payment Advisory Commission noted that the presence of two overlapping quality reporting systems (Five Star and the QIP) that use different methodology was potentially confusing and unnecessary. 24 Some of these issues were addressed for Moving forward, 2014 performance is the baseline for subsequent star thresholds 22 ;accordingly, in 2016, the proportion of facilities in each star category will not necessarily match the forced normal distribution. The CMS notes that, when performance deviates too far from a normal distribution, they will rebase these thresholds to reinstate the fixed distribution. ESCOs, also known as the Comprehensive ESRD Care Demonstration, are a model for dialysis clinics, nephrologists, and other providers to coordinate care for dialysis beneficiaries. ESCOs are accountable for clinical and financial outcomes, including all dialysis services but excluding Medicare Part D costs and costs attributable to transplant evaluation and transplantation. Some of the quality metrics for ESCOs mirror those in the QIP, although many others were drawn from primary care focused accountable care organizations. 25 Unlike the QIP and Dialysis Facility Compare,theMACRAtargetsphysicians and other providers, creating a QPP that endeavors to pay clinicians for value and quality. 23 This bipartisan legislation approaches care provision through one of two paths: the MIPS and the APMs. The MIPS streamlined prior quality programs, including the Patient Quality Reporting System, the Value-Based Modifier Program, and the Medicare Electronic Health Record incentive program (Meaningful Use), into a single program comprised of quality metrics from across the spectrum of medicine. A basic tenet of the QPP is that the provider assumes risk either on the basis of their ability to meet metrics (MIPS) or to control costs while providing highquality care (advanced APMs). EFFECTS OF THE QIP AND OTHER DIALYSIS QUALITY PROGRAMS These dialysis quality assessment programs have a substantial effect on provision of care as clinicians, patients, regulators, and dialysis organizations scramble to keep up with the frequent release of wide-ranging regulations by the CMS. The effects of the QIP can be examined in the context of the Institute of Medicine domains of quality: safety, effectiveness of care, patient-centered approaches, timeliness, efficiency, and equitability of care. 1 Safe care implies avoidance of harm. The initial QIP quality measures, which addressed anemia management and dialysis adequacy, were not focused on safety per se but established a minimum use threshold. In the 2015 final rule, the CMS specifically mapped two National Healthcare Safety Network (NHSN) measures to the safety domain: the NHSN Bloodstream Infection (BSI) Measure and the NHSN Healthcare Personnel Influenza Vaccination Reporting Measure. Effective implies the provision of services on the basis of scientific knowledge to all who could benefit, and refraining from services to those unlikely to benefit. Although the QIP aims to use quality measures that have gone through an appropriate quality measure lifecycle (Figure 1), many of the measures in the QIP, including those endorsed by the NQF, lack data showing efficacy. For example, the hypercalcemia measure, which penalizes facilities for the number of patients with serum calcium (unadjusted for serum albumin) above 10.2 mg/dl, is entirely predicated on relationships from observational cohort data. In fact, the one clinical trial indirectly targeting calcium lowering using cinacalcet versus placebo in a study population with mean serum calcium of 9.7 mg/dl showed no difference in all-cause mortality between groups. 26 Patient-centered care is respectful and responsive to individual patient preferences. Initially, the QIP was devoid of such measures; despite improvements, it still has far to go. The newer QIP measures, such as reporting measures for pain and depression, both of which are under-recognized and undertreated in patients on dialysis, target these issues Although the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems addresses patient experience and engagement, it does not address quality of life and in fact, as reflected by very low response rates, may frustrate patients. An improved survey incorporating patient preferences and patient-relevant symptoms may provide more patient-centered information. 16 Timely and efficient care implies an experience that avoids waste and harmful delays. As the QIP evolves, we must be parsimonious as we adopt new measures, considering the need to retire measures as they become clinically topped out or do not have appropriate scientific weight to result in meaningful outcomes for our patients. Resources will continue to be limited, and new mandates must be considered cautiously for this vulnerable population, recognizing that, in a setting of finite resources, emphasis on one item may detract from attention to others. Lastly, care must remain equitable in this environment where many patients are socioeconomically disadvantaged. The CMS must evaluate cherry picking of patients on the basis of characteristics that might result in better QIP performance and be cognizant of unintended consequences when selecting measures and designing measure specifications for ESRD quality metrics. THE NHSN BSI MEASURE: A CASE STUDY One measure that illustrates the challenges inherent with meaningful quality measures is the NHSN BSI Clinical Measure. Infections are an important cause of morbidity, hospitalization, and rehospitalization in patients on dialysis and the second leading cause of death. 10,30,31 Because infection rates are potentially modifiable and because reducing infections would reduce morbidity and mortality, an infection measure theoretically is appropriate for the QIP Journal of the American Society of Nephrology J Am Soc Nephrol 28: , 2017

9 BRIEF REVIEW The NHSN Dialysis Event Reporting Measure was adopted in PY 2014 as a reporting measure to reconcile infections in patients on hemodialysis, describe treatments, and potentially attribute infections to vascular access. Beginning in PY 2016, the NHSN Dialysis Event Reporting Measure transitioned to the NHSN BSI Clinical Measure, which evaluated the number of new positive blood culture events on the basis of blood cultures drawn either as an outpatient or within 1 day of hospital admission. The clinical measure has critical limitations. If a facility is not diligent and proactive in obtaining data from other settings, infections will be under-reported; in fact, data from the Centers for Disease Control and Prevention and Dialysis Clinic, Inc. suggest significant underascertainment of BSIs, largely attributed to cultures drawn on day 1 or 2 of hospitalization. 32 Importantly, the more blood cultures that a facility reports, including false positive growth on contaminants like Corynebacterium,the more likely they are to incur a QIP penalty. In the 2017 proposed rule (PY 2019), the CMS states: On the one hand, if we incentivize facilities to report monthly dialysis event data but do not hold them accountable for their performance, we believe that facilities will be more likely to accurately report all dialysis events... Nevertheless, incentivizing full and accurate reporting without financial consequences for poor performance will not necessarily improve patient safety. On the other hand, if we incentivize facilities to achieve high clinical performance scores without also incentivizing them to accurately report monthly dialysis event data, we believe that facilities will be less likely to report complete and accurate monthly data, which could diminish the integrity of the NHSN surveillance system and the quality improvement efforts that it supports. 33 Struggling to balance these factors, for PY 2019, the CMS proposed a Safety Domain that includes both the NHSN Dialysis Event Reporting Measure and the NHSN BSI Clinical Measure, attempting to incentivize reporting despite the clear financial disincentive to report. These infection measures highlight the challenge of creating a meaningful quality program in dialysis, where burden of reporting, ease of data acquisition, importance of the topic addressed, potential unintended consequences associated with the presence of a measure, and other factors threaten the success of this process. Although the ESRD QIP has not yet bridged the quality chasm for patients on dialysis, the instructional scaffolding is in process. Since the implementation of the QIP, outcomes for patients on dialysis have continued to improve, and patients on dialysis continue to live longer. Fistula rates have continued to rise, and catheters have decline. However, these achievements may represent low-hanging fruit and may be unrelated to the QIP. As the QIP and other quality assessment programs continue in the dialysis space, several themes recur as the community struggles with defining quality for mass consumption. These include incorporating a more patient-centered approach to measure development and implementation. To avoid falling into a quality abyss, measures should be individualized, emphasizing continued meaningful, actionable, and quantifiable items with increased parsimony and focus given resource limitations. Future steps should consolidate quality programs, improving the efficiency, clarity, and usability of quality measures, while allowing more resources to be dedicated toward direct patient care. Although the importance of the patient-clinician relationship is not always measurable, it remains at the crux of quality and patient-centered care. This relationship, despite the proliferation of metrics, must not change. ACKNOWLEDGMENTS We acknowledge the Public Policy Board of the American Society of Nephrology for providing a robust learning environment regarding the many issues discussed within the body of this work. Both D.W. and S.W. are members of the American Society of Nephrology Public Policy Board. The institution of D.W. receives support from Dialysis Clinic, Inc. (DCI) for his work on DCI projects related to research. DISCLOSURES None. REFERENCES 1. 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