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American Journal of Kidney Diseases

Meeting the 2012 QIP (Quality Incentive Program) Clinical Measures: Strategies for Dialysis Centers

      The US Centers for Medicare & Medicaid Services end-stage renal disease Quality Incentive Program (QIP) is a pay-for-performance program that reduces dialysis center payments by up to 2% for suboptimal patient care. In January 2012, the performance year began for payment year 2014, bringing significant changes to the QIP by introducing 6 quality indicators (3 clinical measures and 3 reporting measures) and a new scoring methodology. To succeed under the new QIP, dialysis facilities must meet 3 clinical measures that assess anemia management, hemodialysis adequacy, and vascular access type in patients receiving dialysis treatment, as well as 3 reporting measures that involve the reporting of dialysis safety events, attestation of administering a patient satisfaction survey, and attestation of patient mineral metabolism monitoring. To help dialysis providers reach these targets, this article provides an overview of the 3 clinical measures and the QIP scoring methodology, as well as a description of patient claims that are excluded when the scores for these measures are calculated. Strategies and solutions that address provider- and patient-related factors also are discussed to help ensure that more dialysis centers meet the new QIP clinical measures for performance year 2012/payment year 2014.

      Index Words

      On January 1, 2012, the performance year started for payment year (PY) 2014 of the US Centers for Medicare & Medicaid Services (CMS) end-stage renal disease (ESRD) Quality Incentive Program (QIP). The proposed QIP for PY 2014 (performance year 2012) has changed significantly compared with PY 2012 and PY 2013 and now includes 6 quality indicators (3 clinical measures and 3 reporting measures) and a new scoring methodology.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      The reporting measures are discussed in limited detail here, but more information is available in other references.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      • Fishbane S.
      • Miller I.
      • Danko H.
      • Masani N.
      The QIP: will it improve dialysis care? An overview.
      • Fishbane S.
      • Miller I.
      • Wagner J.D.
      • Masani N.N.
      Changes to the end-stage renal disease Quality Incentive Program.
      Instead, this article focuses on strategies and solutions to help dialysis providers reach the targets for the 3 clinical measures for PY 2014.

      Changes for PY 2014/Performance Year 2012

      Clinical Measures

      Three clinical measures will be used for PY 20141,2: anemia management, hemodialysis adequacy, and type of vascular access.

      Anemia Management Measure

      The anemia management measure is defined as the percentage of patients with mean hemoglobin levels >12 g/dL while receiving erythropoiesis-stimulating agent (ESA) therapy. This measure is unchanged from PY 2013. When calculating the hemoglobin measure, claims will be excluded if the patient
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      :
      • Is younger than 18 years as of the start date of the claim
      • Is in the first 89 days of ESRD as of the start date of the claim
      • Has a reported hemoglobin value (or hematocrit value divided by 3) <5 g/dL or >20 g/dL
      • Is not treated with ESAs according to the claim; specifically, epoetin alfa or darbepoetin alfa
      • Has fewer than 4 total months of eligible claims at the facility for performance year 2012

      Hemodialysis Adequacy Measure

      The hemodialysis adequacy measure is defined as the percentage of patients with a median urea reduction ratio (URR) ≥65%. This measure is unchanged from PY 2013. The CMS originally proposed changing the dialysis adequacy measure to Kt/V (K = dialyzer clearance, t = dialysis time, and V = total body water volume), but reverted to using the URR measure in the Final Rule due to lack of standardization for Kt/V. When calculating the hemodialysis adequacy measure, claims will be excluded if the patient
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      :
      • Is younger than 18 years as of the start date of the claim
      • Has fewer than 7 dialysis sessions per month (Healthcare Common Procedure Coding System modifier = G6)
      • Is in the first 182 days of ESRD as of the start date of the claim
      • Is treated by home hemodialysis or peritoneal dialysis according to the claim
      • Is treated by frequent hemodialysis (≥4 sessions per week)
      • Has fewer than 4 total months of eligible claims at the facility for performance year 2012

      Vascular Access Type Measure

      The vascular access type measure is a new addition for PY 2014 and consists of 2 submeasures: the percentage of hemodialysis patients for whom the last treatment of the month was performed through an arteriovenous (AV) fistula (with 2 needles) and the percentage of hemodialysis patients for whom an intravenous catheter was used for the last treatment of the month and for 90 days prior to the last dialysis session (without a fistula or graft in place). The actual calculation will be based on the number of patient-months with a fistula or catheter divided by total patient-months.
      When calculating the AV fistula submeasure, claims will be excluded if the patient
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      :
      • Is younger than 18 years as of the start date of the claim
      • Is treated by peritoneal dialysis according to the claim
      • Has fewer than 4 total months of eligible claims at the facility for performance year 2012
      When calculating the intravenous catheter submeasure, claims will be excluded if the patient
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      :
      • Is younger than 18 years and 90 days as of the start date of the claim
      • Is treated by peritoneal dialysis according to the claim
      • Does not have 4 consecutive months of eligible claims at the facility

      Reporting Measures

      Although the reporting measures make up only 10% of the quality indicators of the QIP for PY 2014, compliance with these measures can be more time consuming for dialysis providers compared with meeting the 3 clinical measures. Three reporting measures will be used for PY 2014.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      1. Reporting of dialysis safety events (currently dialysis-related infections) to the National Healthcare Safety Network (NHSN), a program administered by the US Centers for Disease Control and Prevention. The goal of this reporting measure is to support national goals to reduce health care–associated infection rates. To receive the maximal 10 points for this measure, a dialysis center needs to enroll in the NHSN and complete the required training prior to or during calendar year 2012. At least 3 consecutive months of dialysis event data from calendar year 2012 also must be reported by March 31, 2013. A dialysis center will earn 5 points if it enrolls in the NHSN and completes the required training during or prior to calendar year 2012. Dialysis centers will receive zero points if they fail to enroll and complete training.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      2. Attestation of administering a patient satisfaction survey (the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems [ICH CAHPS]). The ICH CAHPS is a standardized questionnaire used to survey adult patients with ESRD about their experiences at the dialysis facilities providing their hemodialysis and requires an independent survey administrator. In order to earn the maximal 10 points for this measure, a dialysis center must report that it administered this survey through CROWNWeb by January 30, 2013. Zero points are received if a dialysis center does not attest that it completed the survey.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      3. Attestation that mineral metabolism monitoring (serum calcium and serum phosphorus) has occurred on at least a monthly basis. There currently is no consensus on the appropriate targets for serum calcium and phosphorus levels in patients receiving hemodialysis, but the purpose of this measure is to improve the detection of bone mineral metabolism abnormalities. A dialysis center will be awarded the maximal 10 points if it reports through CROWNWeb that serum phosphorus and calcium were measured at least monthly in their Medicare patients throughout calendar year 2012. A dialysis center will receive zero points if it does not make this attestation.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      As improved evidence emerges that supports the relationship between mineral measurements and outcomes, these reporting measures may evolve into clinical measures.
      The clinical measures represent 90% of the Total Performance Score (TPS) and the reporting measures constitute the remaining 10%. Facilities must have at least 11 patients eligible for each measure to receive a TPS.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      Adult peritoneal dialysis–only facilities are evaluated on only 2 of the QIP measures: the anemia management clinical measure and the mineral metabolism reporting measure. Adult home-hemodialysis facilities must report on 3 of the QIP measures: the anemia management and vascular access type clinical measures and the mineral metabolism reporting measure.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.

      Anemia Management Measure

      ESA Labeling Changes

      In June 2011, the US Food and Drug Administration (FDA) announced modified dosing recommendations for ESA use in patients with chronic kidney disease (CKD). The revised ESA labels warn that patients with CKD have greater risks of death, serious adverse cardiovascular reactions, and stroke when given ESAs aimed at a hemoglobin level >11 g/dL. Most importantly, no clinical trials have found a hemoglobin target level, ESA dose, or dosing strategy that decreases these risks.
      For patients with CKD on dialysis therapy, the FDA now recommends that ESA treatment be started when hemoglobin levels are <10 g/dL (Box 1). Patients should be given the lowest ESA dose sufficient to reduce the need for red blood cell transfusions. Hemoglobin levels should be monitored at least weekly until stable when beginning or adjusting ESA therapy. Hemoglobin levels then can be checked monthly when stable. If the hemoglobin level approaches or is >11 g/dL, the ESA dose should be reduced or stopped.
      US Food and Drug Administration
      Modified dosing recommendations to improve the safe use of erythropoiesis-stimulating agents (ESAs) in chronic kidney disease FDA Drug Safety Communication 6/24/2011.
      FDA Recommendations for Patients With CKD on Dialysis
      • Start ESA treatment when Hb levels are <10 g/dL
      • Use the lowest ESA dose sufficient to reduce the need for red blood cell transfusions
      • Monitor Hb levels weekly when initiating or adjusting ESA therapy
      • Check Hb levels monthly when stabilized
      • Stop or decrease ESA dose if Hb levels approach or are >11 g/dL
      Abbreviations: CKD, chronic kidney disease; ESA, erythropoietin-stimulating agent; Hb, hemoglobin.
      These changes came about upon further review of existing clinical data. The recommendations are based mostly on results from TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) with supporting data from the NHS (Normal Hematocrit Study) and the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) trial.
      • Pfeffer M.A.
      • Burdmann E.A.
      • Chen C.-Y.
      • et al.
      TREAT Investigators
      A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.
      • Besarab A.
      • Bolton W.K.
      • Browne J.K.
      • et al.
      The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin.
      • Singh A.K.
      • Szczech L.
      • Tang K.L.
      • et al.
      CHOIR Investigators
      Correction of anemia with epoetin alfa in chronic kidney disease.
      Interestingly, the NHS was the only study conducted in patients with CKD treated by hemodialysis who had coronary artery disease or congestive heart failure.
      • Besarab A.
      • Bolton W.K.
      • Browne J.K.
      • et al.
      The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin.
      Much is unknown about optimal anemia treatment. The QIP anemia measure is meant to avoid hemoglobin levels >12 g/dL, but the present literature does not suggest that transient increases in hemoglobin to a level >12 g/dL are harmful. The accumulated literature simply indicates that prolonged targeting of hemoglobin levels >13 g/dL increases risk. Although long-term targeting of hemoglobin levels of 11 or 12 g/dL have not been tested adequately and also may increase risk, there is no evidence that transient increases in hemoglobin level to >12 g/dL are problematic. In our opinion, because anemia remains an important cause of symptoms and diminished quality of life, it is important not to overreact to the hemoglobin >12 g/dL indicator. In our view, protocols should avoid undertreatment of anemia and reduce the need for red blood cell transfusions.

      Anemia Management in View of the QIP Anemia Measure

      The QIP anemia measure counts the number of patients with mean annual hemoglobin levels >12 g/dL as a percentage of all eligible patients at the facility. Dialysis claims are the source of data, so the latest hemoglobin level (or hematocrit) for the month reported on claims serves as the basis for calculations. Only claims in which hemoglobin level is >12 g/dL and an ESA is administered are included in the numerator. However, it is not possible to fully relate ESA dosing to the hemoglobin concentration from the claim. For example, if the hemoglobin level earlier in the month was 11.4 g/dL and an ESA was given, the claim will show ESA dose administration. If at the end of the month the hemoglobin level is >12 g/dL, even if the ESA therapy is discontinued, the claim probably will be included as a hemoglobin level >12 g/dL with ESA administration. Despite this, the risk is low because a patient would be part of the numerator only if the patient's mean hemoglobin level for all eligible claims for performance year 2012 is >12 g/dL.
      Success with this measure requires avoiding higher hemoglobin levels by following the FDA label: holding or decreasing the ESA dose when hemoglobin level is >11 g/dL. Facilities should be able to come close to 100% compliance with protocols that work this way. At the same time, it is important to avoid hemoglobin levels that decrease enough to increase symptoms or result in the need for blood transfusion. Symptoms of fatigue or dyspnea require careful consideration of individualization of hemoglobin target.
      The ability to maintain hemoglobin levels within a clinically acceptable range is hindered by hemoglobin cycling. This phenomenon, which is defined as up-and-down oscillations of hemoglobin levels during ESA treatment, is a common occurrence in patients on hemodialysis therapy. In one study, increases in ESA dose, intravenous iron treatment initiation, increases in intravenous iron dose, and post hospital discharge were associated with up excursions, whereas ESA dose holding, ESA dose reduction, infections, discontinuation of iron therapy, and hospitalization were linked to down excursions in hemoglobin levels.
      • Fishbane S.
      • Berns J.S.
      Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin.
      Additionally, changes in volume status can affect hemoglobin concentration. Patient-related factors that contribute to hemoglobin cycling include recent hospitalization, ESA resistance, dialysis adequacy, inflammation, interdialytic weight gain, secondary hypothyroidism, chronic infections, blood loss, or hemolysis. Practice pattern–related causes include alterations in frequency and dose of ESA, narrow target hemoglobin range, administration of iron therapy, volume removal at dialysis, route of ESA administration, frequent sampling, and laboratory errors.
      • Fishbane S.
      • Berns J.S.
      Evidence and implications of haemoglobin cycling in anaemia management.
      • Singh A.K.
      • Milford E.
      • Fishbane S.
      • Keithi-Reddy S.R.
      Managing anemia in dialysis patients: hemoglobin cycling and overshoot.
      Dialysis providers can take steps to limit hemoglobin cycling in their patients. Iron deficiency can be prevented by measuring iron status every 1-3 months and administering intravenous iron if needed.
      National Kidney Foundation
      KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease.
      National Kidney Foundation
      KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease: 2007 update of hemoglobin target.
      Instead of following “load-and-hold” practices or administering a repletion course of iron therapy only, intravenous iron can be administered in small doses on a regular basis after iron repletion therapy.
      • Fishbane S.
      • Larson K.
      • VanBuskirk S.
      Stabilizing hemoglobin levels: what's new in IV iron and anemia management?.
      • Besarab A.
      • Amin N.
      • Ahsan M.
      • et al.
      Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients.
      • Bolaños L.
      • Castro P.
      • Falcón T.G.
      • Mouzo R.
      • Varela J.M.
      Continuous intravenous sodium ferric gluconate improves efficacy in the maintenance phase of EPOrHu administration in hemodialysis patients.
      Dialysis providers also need to identify and manage other underlying factors that contribute to anemia, hemoglobin cycling, or ESA hyporesponsiveness, such as infection and inflammation.
      • Kalantar-Zadeh K.
      • Aronoff G.R.
      Hemoglobin variability in anemia of chronic kidney disease.
      Finally, frequent or drastic adjustments in ESA doses should be avoided.
      • Fishbane S.
      • Berns J.S.
      Evidence and implications of haemoglobin cycling in anaemia management.
      • Kalantar-Zadeh K.
      • Aronoff G.R.
      Hemoglobin variability in anemia of chronic kidney disease.
      Due to the practice of not allowing time for physiologic changes that contribute to hemoglobin cycling to occur, it is important that dialysis providers do not just respond to a number. For lower hemoglobin targets, the lowest dose of ESA needed to maintain stability is recommended and may prevent dosing holds and hemoglobin cycling.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      Dosing less frequently may circumvent the human tendency to be too reflexive with dose changes. A more conservative or fine-tuned approach to ESA dosing is recommended when hemoglobin levels are stable.
      • Kalantar-Zadeh K.
      • Aronoff G.R.
      Hemoglobin variability in anemia of chronic kidney disease.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      More studies are still needed to determine whether longer dosing intervals or different types of ESAs are associated with less hemoglobin cycling or variability in patients with CKD on hemodialysis therapy.

      Hemodialysis Adequacy Measure

      A recent study reported that almost 90% of variability in URR target achievement was caused by patient factors, not facility factors.
      • Tangri N.
      • Tighiouart H.
      • Meyer K.B.
      • Miskulin D.C.
      Both patient and facility contribute to achieving the Centers for Medicare and Medicaid Services' pay-for-performance target for dialysis adequacy.
      However, there are steps that both patients and dialysis providers can take to ensure this target is reached. Patient adherence to treatment, underprescription of dialysis by the nephrologist, use of catheters for vascular access, and shortened treatment times are common but remediable barriers to hemodialysis adequacy.
      • Tangri N.
      • Tighiouart H.
      • Meyer K.B.
      • Miskulin D.C.
      Both patient and facility contribute to achieving the Centers for Medicare and Medicaid Services' pay-for-performance target for dialysis adequacy.
      • Sehgal A.R.
      • Leon J.B.
      • Siminoff L.A.
      • Singer M.E.
      • Bunosky L.M.
      • Cebul R.D.
      Improving the quality of hemodialysis treatment: a community-based randomized controlled trial to overcome patient-specific barriers.
      • Sehgal A.R.
      • Snow R.J.
      • Singer M.E.
      • et al.
      Barriers to adequate delivery of hemodialysis.
      • Palevsky P.M.
      • Washington M.S.
      • Stevenson J.A.
      • et al.
      Barriers to the delivery of adequate hemodialysis in ESRD Network 4.
      Dialysis providers also can start by monitoring their patients to identify those with URRs close to 65% and at risk of reaching <65% sooner.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.

      Strategies to Help Keep Patients Above the Hemodialysis Adequacy Target

      The average dialysis treatment time is 214 minutes (3.6 hours) at dialysis facilities in the United States.

      Tentori F, Zhang J, Li Y, et al. Longer dialysis session length is associated with better intermediate outcomes and survival among patients on in-center three times per week hemodialysis: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS) [published online ahead of print March 19, 2012]. Nephrol Dial Transplant. doi:10.1093/ndt/gfs021.

      Although studies such as the Hemodialysis (HEMO) Study have not found a clear benefit for increased time on dialysis, in other studies, longer treatment times (>4 hours) have been associated with lower mortality rates.
      • Eknoyan G.
      • Beck G.J.
      • Cheung A.K.
      • et al.
      Hemodialysis (HEMO) Study Group
      Effect of dialysis dose and membrane flux in maintenance hemodialysis.
      • Chertow G.M.
      • Levin N.W.
      • Beck G.J.
      • et al.
      FHN Trial Group
      In-center hemodialysis six times per week versus three times per week.
      • Lacson Jr, E.
      • Brunelli S.M.
      Hemodialysis treatment time: a fresh perspective.
      • Saran R.
      • Bragg-Gresham J.L.
      • Levin N.W.
      • et al.
      Longer treatment time and slower ultrafiltration in hemodialysis: associations with reduced mortality in the DOPPS.
      • Lacson Jr, E.
      • Wang W.
      • Lester K.
      • Ofsthun N.
      • Lazarus J.M.
      • Hakim R.M.
      Outcomes associated with in-center nocturnal hemodialysis from a large multicenter program.
      • Miller J.E.
      • Kovesdy C.P.
      • Nissenson A.R.
      • et al.
      Association of hemodialysis treatment time and dose with mortality and the role of race and sex.
      • Brunelli S.M.
      • Chertow G.M.
      • Ankers E.D.
      • Lowrie E.G.
      • Thadhani R.
      Shorter dialysis times are associated with higher mortality among incident hemodialysis patients.
      Patients who had longer treatment times also had lower pre- and postdialysis systolic blood pressures, greater interdialytic weight losses, higher hemoglobin levels (for the same ESA dose), and higher serum albumin and potassium levels, as well as lower serum phosphorus levels and white blood cell counts, compared with those who had shorter treatment times.

      Tentori F, Zhang J, Li Y, et al. Longer dialysis session length is associated with better intermediate outcomes and survival among patients on in-center three times per week hemodialysis: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS) [published online ahead of print March 19, 2012]. Nephrol Dial Transplant. doi:10.1093/ndt/gfs021.

      Therefore, it may be beneficial to increase treatment times to at least 4 hours for many patients, especially those using catheters or with URRs close to or <65%.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      • Lacson Jr, E.
      • Brunelli S.M.
      Hemodialysis treatment time: a fresh perspective.
      One strategy is to initiate dialysis therapy at the expected eventual treatment time, rather than starting with short treatments and then gradually trying to later increase treatment time. For patients who have difficulty tolerating longer hemodialysis sessions, peritoneal dialysis, home hemodialysis, or kidney transplant should be considered. Increasing the dialyzer size or membrane surface area also can help keep patients above the hemodialysis adequacy target provided the blood flow rate is adequate.
      • Ward R.A.
      Do clinical outcomes in chronic hemodialysis depend on the choice of a dialyzer?.
      It is necessary to educate patients about the importance of having a URR ≥65% and adhering to their prescribed treatment times. Interventions that addressed specific barriers to hemodialysis adequacy have been found to be beneficial. For example, when patients were educated about the meaning and importance of adequate dialysis dose and their reasons for short treatment times were identified and addressed, their Kt/V values increased. In this study, patients were reluctant to extend their treatment times because of work or family conflicts, transportation problems, dialysis-associated symptoms, or medical limitations, such as back pain from prolonged sitting. With the help of the study coordinator, nephrologists were able to address dialysis-associated symptoms and social workers were able to focus on transportation and time issues to help patients overcome these barriers.
      • Sehgal A.R.
      • Leon J.B.
      • Siminoff L.A.
      • Singer M.E.
      • Bunosky L.M.
      • Cebul R.D.
      Improving the quality of hemodialysis treatment: a community-based randomized controlled trial to overcome patient-specific barriers.
      In addition, educational materials, such as patient newsletters covering this topic, can be beneficial. For a summary of recommendations to help keep patients above the hemodialysis adequacy target, see Box 2.
      Summary of Recommendations to Stay Above the Hemodialysis Adequacy Target
      • Increase dialysis treatment times to at least 4 h, especially for patient using catheters or with URRs close to or <65%
      • Start dialysis at the expected eventual treatment time instead of gradually increasing to longer treatment times
      • Educate patients about the importance of having URRs ≥65%
      • Identify and address patient barriers to longer treatment times
      • Consider peritoneal dialysis, home dialysis, or kidney transplant for patients who cannot tolerate longer treatment times
      Abbreviation: URR, urea reduction ratio.

      Vascular Access Type Measure

      This measure is a combination of 2 submeasures; one for AV fistula use during the last treatment of the month and one for dialysis catheter use during the last treatment of the month and for at least 89 days prior.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      The 2 submeasures are averaged to determine the vascular access type score. Because fistulas may not be appropriate for all patients, the catheter rate is not expected to be zero.
      When calculating the submeasure for catheter use, patients are included in the denominator if they are at least 18 years and 90 days old and have 4 eligible claims for performance year 2012. In contrast to the anemia management and hemodialysis adequacy clinical measures, claims must be for 4 consecutive months, but only 1 of the 4 months must be in 2012 and can include October through December 2011. Patients who have a catheter and either a fistula or AV graft are included in the denominator, but not in the numerator, which assumes that the fistula or graft is being used. If patients have used a catheter for at least 90 days, they are included in the numerator. Similar to the anemia management and hemodialysis adequacy clinical measures, the AV fistula submeasure counts patients with 4 total, not necessarily consecutive, months of eligible claims in performance year 2012. Patients are counted as having an AV fistula if 2 needles are used for access.
      The following example demonstrates how to calculate the percentages for these 2 submeasures. A patient received dialysis treatment through a catheter beginning in November 2011. This patient then had a fistula placed in April 2012, which was ready for cannulation at the end of the month. In February and March 2012, because this patient had at least 4 consecutive months of claims and used a catheter only, he or she would be included in the numerator of the equation to calculate the catheter submeasure for these 2 months. From April to July 2012, because this patient is now using the fistula for dialysis access, he or she will be counted in the denominator of the catheter submeasure. After receiving 4 total months of dialysis treatment using the fistula with 2 needles, the patient now can be included in the numerator for the fistula submeasure calculation beginning in August 2012.

      Patient Resistance to AV Fistulas

      AV fistula use is associated with lower rates of mortality and morbidity compared with catheter use in patients undergoing hemodialysis.
      • Dhingra R.K.
      • Young E.W.
      • Hulbert-Shearon T.E.
      • Leavey S.F.
      • Port F.K.
      Type of vascular access and mortality in US hemodialysis patients.
      • Pastan S.
      • Soucie J.M.
      • McClellan W.M.
      Vascular access and increased risk of death among hemodialysis patients.
      • Xue J.L.
      • Dahl D.
      • Ebben J.P.
      • Collins A.J.
      The association of initial hemodialysis access type with mortality outcomes in elderly Medicare ESRD patients.
      • Polkinghorne K.R.
      • McDonald S.P.
      • Atkins R.C.
      • Kerr P.G.
      Vascular access and all-cause mortality: a propensity score analysis.
      • Astor B.C.
      • Eustace J.A.
      • Powe N.R.
      • Klag M.J.
      • Fink N.E.
      • Coresh J.
      CHOICE Study
      Type of vascular access and survival among incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for ESRD (CHOICE) Study.
      • Pisoni R.L.
      • Arrington C.J.
      • Albert J.M.
      • et al.
      Facility hemodialysis vascular access use and mortality in countries participating in DOPPS: an instrumental variable analysis.
      In addition, patients who were dialyzed using AV fistulas had higher mean values for URR and Kt/V compared with those who were dialyzed with catheters.
      • Chand D.H.
      • Teo B.W.
      • Fatica R.A.
      • Brier M.
      Medical Review Board of The Renal Network, Inc
      Influence of vascular access type on outcome measures in patients on maintenance hemodialysis.
      The number of patients using a fistula for dialysis access reached 60.4% as of February 2012, which is getting closer to the Fistula First Breakthrough Initiative (FFBI) goal of 66%.
      Fistula First Breakthrough Initiative National AV fistula rate.
      However, not all dialysis centers are meeting this target and results vary across geographic regions.
      • Lynch J.R.
      • Mohan S.
      • McClellan W.M.
      Achieving the goal: results from the Fistula First Breakthrough Initiative.
      It is important to set the right expectations for patients and educate them about the possibility of fistula failure (25%), the potential need for a different access in case the first fistula fails, and the need for repeated angioplasty procedures to help mature the fistula.
      Patients are reluctant to use AV fistulas for vascular access for many reasons. They may not want to deal with the complications and hassle associated with surgical placement of the fistula. Some patients do not want to experience cannulation and have anxiety about frequent needle pokes. They also may be depressed or anxious when initiating dialysis therapy and may not want to undergo another procedure. They may not want to have to wait for the fistula to stop bleeding after dialysis. Body image concerns due to the unsightly fistulas also may exist. Patients may be satisfied with using catheters for dialysis access, have misconceptions about the risk of infection associated with catheters, or be unaware that fistulas are an option for them. In addition, patient-to-patient communication regarding others' negative experiences and the patient's previous negative experiences with fistula access and maturation have a role.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      • Xi W.
      • Harwood L.
      • Diamant M.J.
      • et al.
      Patient attitudes towards the arteriovenous fistula: a qualitative study on vascular access decision making.
      Patients using fistulas for dialysis access were more likely to be bothered by pain, bleeding, bruising, swelling, and the appearance of their access compared with patients with catheters.
      • Quinn R.R.
      • Lamping D.L.
      • Lok C.E.
      • et al.
      The Vascular Access Questionnaire: assessing patient-reported views of vascular access.

      Patient Education for AV Fistulas

      There are a number of steps that dialysis providers can take to encourage more patients to consider fistulas for dialysis access. Their involvement is especially important because patients have stated that interactions with and information from dialysis providers were helpful in influencing their decision to consider AV fistulas.
      • Xi W.
      • Harwood L.
      • Diamant M.J.
      • et al.
      Patient attitudes towards the arteriovenous fistula: a qualitative study on vascular access decision making.
      These discussions should be started early in CKD stages 4-5 and should involve different disciplines. Patients with greater dialysis knowledge were more likely to use an AV fistula or graft compared to a catheter at hemodialysis therapy initiation and 6 months after hemodialysis therapy initiation.
      • Cavanaugh K.L.
      • Wingard R.L.
      • Hakim R.M.
      • Elasy T.A.
      • Ikizler T.A.
      Patient dialysis knowledge is associated with permanent arteriovenous access use in chronic hemodialysis.
      As described, some patients were unaware of the risk of infection associated with catheter use or experienced knowledge gaps regarding alternative options for dialysis access.
      • Xi W.
      • Harwood L.
      • Diamant M.J.
      • et al.
      Patient attitudes towards the arteriovenous fistula: a qualitative study on vascular access decision making.
      For these reasons, it is important that eligible patients are educated about the option of AV fistulas, as well as the risks and practical issues (ie, a protective cover must be used for the catheter when the patient takes a shower) associated with catheters. Underlying depression and anxiety also need to be identified and treated in affected patients. Topical anesthetics can be used to manage the pain associated with cannulation.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      However, even if patients apply the medication before they arrive at the dialysis center, dialysis providers need to be aware of the adverse effects and proper application of the medication.
      • Ball L.K.
      Improving arteriovenous fistula cannulation skills.
      Relaxation techniques such as listening to music or using breathing or visualization techniques may benefit patients who experience needle-related anxiety during cannulation. Distraction techniques in which another patient or staff member engages the patient in conversation during cannulation also are helpful.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      • Ball L.K.
      Improving arteriovenous fistula cannulation skills.
      Alternatively, these patients also may wish to consider self-cannulation so they can feel more in control during cannulation.
      • Fishbane S.
      • Dutka P.J.
      Dialysis Center Dialogues: the ESRD QIP final rule.
      Nurses may want to consider using the “tandem hand” technique to teach patients how to self-cannulate.
      • Mott S.
      • Moore H.
      Using “tandem hand” technique to facilitate self-cannulation in hemodialysis.
      Finally, if an AV fistula does not mature within a month of placement, it needs to be evaluated by the nephrologist and surgeon. They then need to determine the extent of intervention for the existing access or if a new access is necessary.
      Fistula First Breakthrough Initiative Cannulation of new fistula policy and procedure.
      Dialysis center nurses also may consider using the buttonhole technique for AV fistula cannulation, which is described in greater detail later in this article. In one survey of patients who previously had used the rope ladder technique and were now using the buttonhole technique, 96% recommended the buttonhole technique and 83% said it was easier for nurses to use. On a scale of 0-10 in which 0 is not at all satisfied and 10 is very satisfied, patients' mean satisfaction was 8.5. Twelve months later, 78% of survey respondents remained satisfied with the buttonhole technique.
      • Hashmi A.
      • Cheema M.Q.
      • Moss A.H.
      Hemodialysis patients' experience with and attitudes toward the buttonhole technique for arteriovenous fistula cannulation.
      However, there are some misconceptions about the buttonhole technique among patients, such as the fear that it will cause aneurysm formation, that need to be addressed.
      • Ball L.K.
      Improving arteriovenous fistula cannulation skills.
      Finally, if these suggestions at first are unsuccessful at encouraging more eligible patients to consider AV fistulas, perseverance is always recommended. For a summary of these recommendations, refer to Box 3.
      Suggestions to Address Patient Resistance to AV Fistulas
      • Start discussing AV fistulas with patients with CKD stages 4-5 before dialysis therapy is initiated
      • Educate patients about the infection risk and other practical issues associated with catheter use
      • Identify and treat anxiety and depression in affected patients
      • Use topical anesthetic to reduce the pain associated with cannulation
      • Use relaxation or distraction techniques to reduce anxiety during cannulation
      • Teach patients to self-cannulate
      • Consider using the buttonhole technique for cannulation
      Abbreviations: AV, arteriovenous; CKD, chronic kidney disease.

      Best Practices for AV Fistula Use

      In 2005, the CMS made an increase in AV fistula use and a decrease in catheter use a priority, which led to development of the FFBI. The FFBI defines several change concepts that dialysis centers can implement to encourage more patients to consider an AV fistula for dialysis access. It also is recommended that each dialysis facility designate expert cannulators among their staff. Expert cannulators are a team of nurses and technicians who have met a set of criteria that recognize their skills as being at the level of expert competency. They often are called on to cannulate difficult and new accesses. For the change concepts, expert cannulator criteria, and additional tools for your dialysis center, visit the FFBI web site at www.fistulafirst.org.

      Cannulation Techniques

      The FFBI outlines a procedure for the cannulation of new fistulas and recommends that newly created primary AV fistulas develop for at least 8-12 weeks before cannulation.
      Fistula First Breakthrough Initiative Cannulation of new fistula policy and procedure.
      According to management guidelines, there is no accepted method for cannulation.
      National Kidney Foundation
      KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: hemodialysis adequacy, peritoneal dialysis adequacy and vascular access.
      The rope ladder technique and site rotation techniques are used most commonly to cannulate AV fistulas in the United States. For more than 30 years, the buttonhole technique or constant site technique has been used for cannulation in Europe and Japan, and it is gaining popularity in the United States.
      • Ball L.K.
      The buttonhole technique for arteriovenous fistula cannulation.
      Few studies have compared the buttonhole technique with other cannulation methods, but it has been associated with some advantages. Buttonhole cannulation is less painful for patients compared with other cannulation techniques.
      • Ball L.K.
      The buttonhole technique for arteriovenous fistula cannulation.
      • Verhallen A.M.
      • Kooistra M.P.
      • van Jaarsveld B.C.
      Cannulating in haemodialysis: rope-ladder or buttonhole technique?.
      • Twardowski Z.J.
      • Kubara H.
      Different site versus constant sites of needle insertion into arteriovenous fistulas for treatment by repeated dialysis.
      Patients can use this technique to self-cannulate and it is endorsed by the NKF-KDOQI (National Kidney Foundation's Kidney Disease Outcomes Quality Initiative) guidelines for self-cannulation.
      National Kidney Foundation
      KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for 2006 Updates: hemodialysis adequacy, peritoneal dialysis adequacy and vascular access.
      • Ball L.K.
      The buttonhole technique for arteriovenous fistula cannulation.
      In addition, it is associated with a lower rate of aneurysm formation compared to the rope ladder technique.
      • Ball L.K.
      The buttonhole technique for arteriovenous fistula cannulation.
      • van Loon M.M.
      • Goovaerts T.
      • Kessels A.G.
      • van der Sande F.M.
      • Tordoir J.H.
      Buttonhole needling of haemodialysis arteriovenous fistulae results in less complications and interventions compared to the rope-ladder technique.
      Dialysis centers benefit because less time is needed to cannulate AV fistulas when the buttonhole technique is used. Missed needle sticks and infiltrations are less likely when the buttonholes are established.
      • Ball L.K.
      The buttonhole technique for arteriovenous fistula cannulation.
      Unfortunately, there are disadvantages associated with the buttonhole technique. Infection rates are higher in patients with AV fistulas cannulated using the buttonhole technique compared with those cannulated with the rope ladder technique.
      • Verhallen A.M.
      • Kooistra M.P.
      • van Jaarsveld B.C.
      Cannulating in haemodialysis: rope-ladder or buttonhole technique?.
      • van Loon M.M.
      • Goovaerts T.
      • Kessels A.G.
      • van der Sande F.M.
      • Tordoir J.H.
      Buttonhole needling of haemodialysis arteriovenous fistulae results in less complications and interventions compared to the rope-ladder technique.
      • Doss S.
      • Schiller B.
      • Moran J.
      Buttonhole cannulation—an unexpected outcome.
      • Marticorena R.M.
      • Hunter J.
      • Macleod S.
      • et al.
      The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators.
      For this reason, it is recommended that only one person create the buttonhole tunnel. A thorough cleaning protocol also is recommended, which includes the patient cleaning the access site prior to sitting in the dialysis chair and dialysis providers cleaning the buttonhole sites before and after scab removal.
      • Verhallen A.M.
      • Kooistra M.P.
      • van Jaarsveld B.C.
      Cannulating in haemodialysis: rope-ladder or buttonhole technique?.
      • Doss S.
      • Schiller B.
      • Moran J.
      Buttonhole cannulation—an unexpected outcome.
      • Ball L.K.
      The buttonhole technique: strategies to reduce infections.
      Advantages of the buttonhole technique, which mainly include patient autonomy, sense of control, and decreased anxiety due to cannulation, have to be balanced with potential infectious risks.

      Total Performance Score

      TPS ranges from 0-100 points and consists of the total score for the 3 clinical measures and 3 reporting measures, which make up 90% and 10% of the TPS, respectively. Scoring of the clinical measures is more complex than scoring for the reporting measures, and a brief overview is provided next. Each of the 3 clinical measures is given an achievement score (range, 0-10) and an improvement score (range, 0-9). The higher of these 2 scores is used as the performance score for that clinical measure.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      The achievement score is derived from the center's performance in 2012 and is considered in the context of national performance during the baseline period of July 1, 2010, to June 30, 2011. The achievement threshold is set at the 15th percentile of the national performance, which becomes the basis for the 0-10 range. Center performance at or higher than the national 90th percentile is termed the benchmark and results in a maximal score of 10 points. A center performing at or lower than the national 15th percentile will receive zero points. A center ranked higher than the achievement threshold (0 points) and lower than the benchmark (10 points) will earn an intermediate score.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      The purpose of the improvement score is to acknowledge the progress a center has made in quality performance, and this score ranges from 0-9 points. The improvement threshold is based on the center's performance during the baseline period of July 1, 2010, to June 30, 2011. The improvement benchmark also is set at the national 90th percentile. If a center scores higher than the improvement benchmark, it earns 9 points. If it scores lower than the improvement threshold, it receives 0 points. Centers will receive an intermediate score between 0 and 9 points if their performance is between the improvement benchmark and improvement threshold.
      Centers for Medicare & Medicaid Services, HHS
      Medicare program; end-stage renal disease prospective payment system and quality incentive program; ambulance fee schedule; durable medical equipment; and competitive acquisition of certain durable medical equipment prosthetics, orthotics and supplies Final rule.
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      Each of the clinical measures accounts for 30% of the TPS. Because the maximum TPS is 100, each clinical measure contributes 30 points maximum. It is expected for PY 2014 that any TPS 53 points or greater will not result in a payment reduction (Table 1). If the full 10 points for reporting measures is earned, the clinical measures need to total 43 points or greater to avoid a payment reduction. Therefore, to earn a summed score of 43 points for the 3 clinical measures, only 50% of the 30 points is needed for each individual clinical measure. However, because the TPS will be reported publicly, dialysis facilities will want to achieve as high a score as possible. Furthermore, the TPS is the first single aggregate scoring system for dialysis quality that is available publicly. As a result, it can be anticipated that newspapers and other media outlets are likely to report comparative scoring. In addition, although the reporting measures account for only 10% of the TPS, the patient satisfaction measure brings the patient's voice into quality measurement, which may become a more important measure in subsequent years.
      Table 1Payment Year 2014 Payment Reductions
      Source: reference
      Centers for Medicare & Medicaid Services
      Special Open Door Forum: end-stage renal disease Quality Incentive Program Final Rule: payment years 2013 and 2014.
      .
      Total Performance ScorePercentage Payment Reduction
      53-100No reduction
      43-520.50
      33-421.00
      23-321.50
      <232.00

      Conclusion

      The ESRD QIP is an attempt by the CMS to link quality to payment. The clinical measures for PY 2014 (performance year 2012) already are monitored closely by dialysis facilities as part of their quality assessment and performance improvement programs. However, dialysis quality is not a homogenous phenomenon. As demonstrated by Spolter et al,
      • Spolter Y.S.
      • Seliger S.L.
      • Zhan M.
      • Hsu V.D.
      • Walker L.D.
      • Fink J.C.
      The relationship between dialysis performance measures: adequacy and anemia management.
      different care processes drive performance and an individual dialysis facility may be more successful at some processes than others. The QIP is likely to increase the focus on these clinical measures, hopefully without detracting from other indicators of quality. It can be expected that for PY 2015 and subsequent years, the program will be expanded, with the addition of more quality indicators.

      Acknowledgements

      The authors acknowledge Jaime Symowicz, PhD, a medical writer/coordinator employed by Spire Learning, for significant contributions to the writing of this article.
      Support: This journal supplement is supported by an educational grant from Takeda Pharmaceuticals International, Inc and Affymax Inc . The associated educational activity is jointly sponsored/coprovided by Boston University School of Medicine and Spire Learning.
      Financial Disclosure: Dr Fishbane has served as a consultant for Affymax Inc, Akebia Therapeutics Inc, and Rockwell Medical Inc. Dr Fishbane is on the Speakers Bureau of AMAG Pharmaceuticals Inc. Dr Hazzan declares that he has no relevant financial interests.

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