CMS Proposed Rule Summary: ESRD PPS for CY 2017; ESRD QIP for PYs 2018, 2019, and 2020; AKI; and CEC Model

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1 CMS Proposed Rule Summary: ESRD PPS for CY 2017; ESRD QIP for PYs 2018, 2019, and 2020; AKI; and CEC Model On June 24, 2016, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model. Below provides an initial assessment of key provisions included in the proposed rule (CMS-1651-P). CMS will accept comments on the proposed rule through August 23, CY 2017 ESRD PPS Impact Analysis: CMS estimates total spending for ESRD facilities in CY 2017 will be approximately $9.7 billion, which takes into account a projected increase in FFS dialysis beneficiary enrollment of 1.5 percent in o CMS projects that updates to the ESRD PPS base rate will increase payments to facilities overall by 0.5 percent from 2016 to o Payments will increase by 0.7 percent for hospital-based facilities and 0.5 percent for freestanding facilities. o Payments will increase for LDOs by 0.5 percent, for regional chains by 0.6 percent, for independent facilities by 0.4 percent and hospital-based facilities by 0.7 percent. Base Rate: CMS proposes a base rate of $ for CY The proposed base rate reflects the following adjustments: o Market Basket / Productivity Adjustment: CMS proposes a net market basket (MB) increase of 0.35 percent for CY The agency projects an ESRDB MB increase of 2.1 percent, reduced by: (1) 1.25 percentage points, as required by the Protecting Access to Medicare Act of 2014 (PAMA); and (2) a productivity factor of 0.5 percent, as required by the Affordable Care Act (ACA). o Wage Index Budget Neutrality Factor: o Home Dialysis Training Add-on Budget Neutrality Factor: Outlier Payments: CMS proposed no major policy changes for outlier payments in CY The agency proposes to use CY 2015 claims data as the basis for Medicare Allowable Payment (MAP) and fixed-dollar loss amounts. o 1 Percent Withhold: CMS proposes to maintain the policy of withholding a targeted 1 percent of ESRD PPS projected payments for outlier purposes. The agency notes based on 2015 claims, outlier payments represented approximately 0.9 percent of total ESRD payments due to small overall declines in use of outlier services. CMS notes we would not increase the base rate to account for years where outlier payments were less

2 than 1 percent of total ESRD PPS payments, nor would we reduce the base rate if the outlier payments exceed 1 percent of total ESRD PPS payments. o Adult Patients: The fixed-dollar loss will decrease from $86.97 in 2016 to $83.00 in The MAP will decrease from $50.81 to $ o Pediatric Patients: The fixed-dollar loss will decrease from $62.19 in 2016 to $67.44 in The MAP will increase from $39.20 to $ o CMS notes that it continues to believe that statute requires it to include an outlier adjustment in the ESRD PPS. Wage Index: CMS proposes no policy changes to the wage index. o Floor: The agency proposes to maintain the wage index floor of o Labor-Related Share: CMS proposes to continue the labor-related share finalized in the CY 2015 ESRD PPS final rule of percent. o Possible Future Changes: CMS solicits public comment on potential changes to wage index policies and notes [a]long with comments we will continue to review wage index values and the appropriateness of a wage index floor in the future. Hemodialysis (HD) Equivalency Payment: CMS proposes an equivalency payment for HD when patients receive more than three treatments per week. o Rationale: Current CMS policy limits payments to no more than 3 treatments per week unless there is a medical justification for more than 3 treatments. CMS proposes to maintain that policy for However evolving technology has produced HD treatments that are generally shorter and afford patients greater flexibility in managing their ESRD and other activities and improves quality of life, CMS explains in the proposed rule. Consequently, some facilities are furnishing services in excess of 3 per week, but not receiving payment for such services. The proposed HD equivalency payment will ensure facilities receive payment in such circumstances and will provide CMS with claims data to determine how many treatments are actually being furnished. o Payment Adjustment: For adult patients, CMS proposes to calculate the per treatment amount based on the number of treatments prescribed by the physician. The payment would be based on the ESRD PPS base rate adjusted by applicable patient and facilitylevel adjustments, the home dialysis training add-on (if applicable), and the outlier payment adjustment (if applicable). CMS provides the following example of payment for a beneficiary whose prescription indicates 5 treatments per week: (Adjusted Base Rate * 3/5) + (Outlier Payment * 3.5) = per treatment payment amount. o Implemented July 1, 2017: While the policy would be effective January 1, 2017, CMS proposes not to operationalize it until July 1, 2017 to give interested parties time to implement the policy. Training Add-On Payment Adjustment: CMS proposes a home and self-dialysis training add-on payment adjustment of $95.57 for 2017 (compared to $50.16 in 2016). Consistent with prior years, a budget-neutrality factor makes the payment budget-neutral within the ESRD PPS. o Increased Adjustment: The adjustment reflects an increase in the amount of assumed nursing time required for training of 2.66 hours (compared to 1.5 in 2016) and a new RN hourly wage of $ The increase represents a weighted average of nursing times inclusive of both modalities, including: (1) the number of training hours required by a registered nurse for peritoneal dialysis (2 hours) and hemodialysis (4 hours) as specified 2

3 in guidelines produced by the Kidney Disease Outcome Quality Initiative (KDOQ); and (2) the percentage of total treatments by modality (approximately 67 percent for PD and 33 percent for HD). o Future Changes to Training Add-On Payment: CMS suggests it may make changes to the training add-on in future years to refine the adjustment and make it more accurate given the wide disparities in reported facility training costs ranging from under $100 to several thousand dollars per treatment. CMS notes it will take several years for the changes to be implemented and yield data that we could use as the basis for a change in the home training add-on payment adjustment. Potential changes could include: Training versus Retraining Treatments: CMS notes it currently cannot distinguish training treatments from retraining treatments on claims data. CMS allows for retraining if the patient changes from one dialysis modality to another; the patient s home dialysis equipment changes; the patient s dialysis setting changes; the patient s dialysis partner changes; or the patient s medical condition changes. CMS intends to issue sub-regulatory guidance to gain data assessing the extent to which patients are retrained and the number of retraining sessions furnished. Training by Modality: CMS notes under the current claims processing system, there is no mechanism that limits the allowable training treatments to 25 for HD and 15 for PD and therefore cannot determine if the patient is still training on the modality versus having completed initial training and needed retraining. CMS will seek data on utilization of each modality. CMS proposes a 3-prong approach to get better cost report data to determine a future training add-on adjustment: Cost Report Analysis: The agency proposes an in-depth analysis of cost reports to determine where cost reports are incorrectly populated, left blank, or deviate from instructions to have a better understanding of actual training costs. CMS wants to determine if there is a systematic problem that may be the result of imprecise instructions. Comprehensive Audits of ESRD Facility Cost Reports: As required by PAMA, these audits will result in greater uniformity in reporting methods, and in turn, heighted data quality in future years. Independent Facility Cost Reports: CMS potentially could update to the independent ESRD facility cost report (CMS ) to include new fields and to rework several worksheets in an effort to obtain more granularity in data on home dialysis training. CMS is also considering a locking mechanism that would prevent a facility from submitting a cost report if certain key fields have not been completed. Advancing Health Information Exchange: CMS continues to encourage but not require stakeholders to utilize HIT and notes that as adoption of certified health IT increases and interoperability standards continue to mature, HHS will seek to reinforce standards through relevant policies and programs. 3

4 Other Policies of Interest: The proposed rule includes no major proposals related to the lowvolume payment adjustment, the rural adjustment, co-morbidity adjustments, case-mix adjustments, or the drug designation process. Acute Kidney Injury Statutory Benefit: Beginning January 1, 2017, Medicare Part B includes coverage for renal dialysis services furnished to a facility or provider for an individual with AKI, as required by the Trade Protection Extension Act of Per statute, the amount of payment is the ESRD PPS base rate adjusted by any applicable geographic adjustment factor and may be adjusted by the Secretary by any other adjustment factor on a budget-neutral basis. Definition of AKI Patient: Consistent with statute, CMS proposes to define an AKI patient as an individual who has acute loss of renal function and does not receive renal dialysis services of which payment is made under section 1881(b)(14). Payment Rate: CMS proposes the AKI payment rate to mean the ESRD per treatment base rate inclusive of the market basket and productivity adjustment and any other adjustment factor applied to the ESRD PPS base rate. Accordingly, CMS proposes the CY 2017 AKI payment rate as $ CMS notes that legislative and other policy decisions could directly impact the ESRD PPS base rate that may not relate to AKI services. However, [i]n those situations, we would still consider the ESRD PPS base rate as the payment for AKI dialysis, CMS states in the proposed rule. Geographic Adjustment Factor: CMS proposes the statutory geographic adjustment factor to mean the adjustment factor that is actually applied to the ESRD PPS base rate for a particular facility. Hence, the AKI dialysis payment would be the ESRD base rate adjusted by a specific facility s wage index. Other Adjustments: CMS proposes no other adjustments to the AKI payment rate at least for the first year of the benefit, as allowed under the statute. However, the agency proposes to codify the Secretary s authority to make such adjustments in future year. Separate Payments: CMS proposes no separate payment for drugs, biologicals, laboratory services, and supplies considered to be renal dialysis services under the ESRD PPS for AKI. However, CMS proposes to allow facilities to bill for separate payments in certain instances: o Recognizing that the intent of dialysis for patients with AKI is curative, CMS proposes to pay for all hemodialysis treatments furnished to AKI beneficiaries in a week, even if that number exceeds the three times per week weekly amount. o CMS also proposes to make separate payments for other services not considered renal dialysis services but related to treatment as a result of AKI. In particular, an ESRD facility could seek separate payment for drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting. Uncompleted Dialysis Treatment: CMS generally expects to pay for only one treatment per day across all settings. However, if a dialysis treatment is started, but the treatment is not completed for unforeseen reasons such as a medical emergency, the ESRD facility and hospital would be paid. 4

5 No Home and Self-Dialysis: CMS understands that AKI patients require supervision by qualified staff and close monitoring through laboratory tests to ensure necessary care. Therefore, CMS proposes to not extend the home dialysis benefit to AKI patients. Vaccine Administration: CMS proposes to allow ESRD facilities to furnish vaccines to beneficiaries with AKI and bill Medicare accordingly. Monitoring: CMS proposes close monitoring of utilization of dialysis treatments and the drugs, labs and services provided to AKI patients based on stakeholder concerns. ESRD Conditions of Coverage and AKI: CMS does not propose specific changes to CfCs in the rule but solicits comment on whether revisions to CfCs may be appropriate for addressing treatment of AKI in ESRD facilities. CMS notes it will not finalize any comments made in this rule but will consider them for future rulemaking. Specifically, CMS asks: o Should we address AKI care directly in the ESRD CfCs? o Should care planning for AKI patients be addressed differently than care planning for ESRD patients? o Are there other areas, such as medical records, that might be appropriate for AKI revisions? Billing: For payment purposes, AKI beneficiaries would be identified through a specific condition code, an AKI diagnosis code, an appropriate revenue code, and an appropriate Common Procedural Terminology code. CMS expects facilities to report all items and services furnished to individuals with AKI and include comorbidity diagnoses on their claims for monitoring purposes. CMS notes it will implement and furnish all billing requirements through subregulatory guidance. Annual Rulemaking: The AKI base rate and any AKI policy changes would be established through formal rulemaking in either the annual ESRD PPS rule or through a Federal Register notice. Any changes to payment methodology and adjustments to the AKI payment rate other than wage index would go through formal rulemaking. If CMS proposes simply to update the payment rate with no methodological or policy changes, it would publish the notice in the Federal Register Payments: CMS estimates it will pay approximately $2.0 million to facilities in 2017 for AKI patients. Quality Incentive Program (QIP) for PY 2018, 2019, and 2020 PY 2018 QIP Proposals FY 2018 QIP Measure Set: The rule proposes no changes to the PY 2018 ESRD QIP measure set finalized in the CY 2017 ESRD PPS Final Rule. For 2018, the QIP contains 8 clinical measures and 3 reporting measures. Hypercalcemia Measure: Consistent with the National Quality Forum (NQF) process for this measure, CMS proposes to: (1) add plasma as an acceptable substrate in addition to serum calcium; and (2) redefine the denominator to include patients regardless of whether any serum calcium values were reported at the facility during the 3-month period. Functionally, this means the measure will include a greater number of patient months. 5

6 PY 2019 QIP Proposals PY 2019 Measure Set: The proposed rule maintains the FY 2019 QIP measure set finalized in the CY 2016 ESRD PPS Final Rule, which contains 7 clinical measures and 5 reporting measures. Reintroduce NHSN Dialysis Event Reporting Measure: CMS proposes to reintroduce this measure because of concerns from stakeholders over under-reporting of the National Healthcare Safety Network (NHSN) Bloodstream Infection (BSI) Clinical Measure. o Aligning with stakeholder concerns, a PY 2014 NHSN data validation feasibility study suggested as many as percent of dialysis events are under-reported. CMS proposes this reporting measure to encourage reporting of dialysis events. NHSN BSI Measure Topic: CMS proposes the NHSN Measure Topic, which will include: (1) the NHSN Dialysis Event Reporting Measure (weighted 40 percent), and (2) the NHSN BSI Clinical Measure (weighted 60 percent). CMS proposes both measures to improve patient safety and quality of care while also increasing dialysis event reporting. New Safety Measure Domain: CMS proposes to create a new Safety Measure Domain for the PY 2019 ESRD QIP compromised of a single measure topic the NHSN BSI Measure Topic. Therefore, it proposes to remove the Safety Subdomain from the Clinical Measure Domain in PY 2019 and future years. Clinical Measure Domain Weighting: CMS proposes to revise the weights in the Clinical Measure Domain for PY 2019 to reflect policy priorities of increased emphasis on outcome and patient experience care measures, as well as the proposed addition of the proposed new Safety Measure Domain. Proposed Clinical Measure Domain Weighting for the PY 2019 ESRD QIP Measure/Measure Topics by Subdomain Measure Weight in the Clinical Domain Measure Domain Score (Proposed for PY 2019) Measure Weight as Percent of Total Performance Score (Proposed for PY 2019) Patient and Family Engagement / Care Coordination Subdomain 42% ICH CAHPS measure 26% 19.5% SRR measure 16% 12% Clinical Care Subdomain 58% STrR measure 12% 9% Dialysis Adequacy measure 19% 14.25% Vascular Access Type measure topic 19% 14.25% Hypercalcemia measure 8% 6% 6

7 Finalized Clinical Measure Domain Weighting for the PY 2019 ESRD QIP (Finalized in the CY 2016 PPS Final Rule) Measure/Measure Topics by Subdomain Measure Weight in the Clinical Domain Measure Domain Score (Finalized for PY 2019) Measure Weight as Percent of Total Performance Score (Finalized for PY 2019) Safety Subdomain 20% NHSN BSI Clinical Measure 20% 18% Patient and Family Engagement / Care Coordination Subdomain ICH CAHPS measure 20% 18% SRR measure 10% 9% Clinical Care Subdomain 50% STrR measure 7% 6.3% Dialysis Adequacy measure 18% 16.2% Vascular Access Type 30% measure topic 18% 16.2% Hypercalcemia measure 7% 6.3% Total Performance Score Weighting: Due the new Safety Measure Domain, CMS proposes to reweight the TPS for PY 2019 as follows: 15 percent for Safety, 75 percent for Clinical Measure Domain, and 10 percent for Reporting Measure Domain. To receive a TPS, a facility would have to have a Clinical Measure Domain score and a Reporting Measure Domain score but not a Safety Measure Domain score. Performance: CMS proposes to maintain the same methodology for performance standards, achievement thresholds, and benchmarks for clinical measures previously finalized for the PY 2019 ESRD QIP. If the final numerical values for these metrics decline from the previous year, the agency also continues to propose that it would substitute the prior years metrics to ensure no lower performance standards. CMS proposes this policy with one exception in PY 2019: it will use the performance standards for the NHSN BSI Clinical Measure irrespective of what values were assigned to performance in PY 2018 based on discussions with the Centers for Disease Control and Prevention (CDC). Payment Reductions: CMS estimates facilities must meet or exceed a minimum TPS of 59 for PY 2019 to not experience a payment reduction. PY 2019 Estimated Payment Reduction Scale Based on Most Recently Available Data Total Performance Score Payment Reduction % % % % % 7

8 Data Validation Pilot: CMS proposes to continue the data validation pilot for PY 2019 using the same sample number of records (10 per facility), same number of facilities (300), and response to request time (60 calendar days). New Data Validation Study for NHSN Dialysis Event Reporting: CMS proposes a new data validation study for NHSN dialysis event reporting that will cover 35 facilities. CMS proposes that facilities will have 30 days to respond and will submit 2 quarters worth of data. PY 2020 ESRD QIP PY 2020 Measure Set: The PY 2020 QIP measure set contains 8 clinical measures and 7 reporting measures. CMS proposes to maintain all clinical measures in PY 2020 because none are topped out. Clinical measures include Kt/V Delivered Dose above minimum, Fistula Use, Catheter Use, Serum Calcium > 10.2, NHSN SIR, SRR, STrR, SHR, and measures within ICH CAHPS: nephrologist communication and caring, quality of dialysis center care and operations, providing information to patients, rating of nephrologist, rating of dialysis facility staff, and rating of dialysis center. PY 2019 ESRD QIP Measures Continued for PY 2020 NQF # Measure Title and Description 0257 Vascular Access Type: AV Fistula, a clinical measure Percentage of patient-months on hemodialysis during the last hemodialysis treatment of the month using an autogenous AV fistula with two needles Vascular Access Type: Catheter 90 days, a clinical measure Percentage of patient-months for patients on hemodialysis during the last hemodialysis treatment of month with a catheter continuously for 90 days or longer prior to the last hemodialysis session. National Healthcare Safety Network (NHSN) Bloodstream Infection in Hemodialysis Patients, a clinical measure The Standardized Infection Ratio (SIR) of Bloodstream Infections (BSI) will be calculated among patients receiving hemodialysis at outpatient hemodialysis centers Hypercalcemia, a clinical measure Proportion of patent-months with 3-month rolling average of total uncorrected serum calcium greater than 10.2 mg/dl Standardized Readmission Ratio, a clinical measure Standardized hospital readmissions ratio of the number of observed unplanned 30-day hospital readmissions to the number of expected unplanned readmissions Standardized Transfusion Ratio, a clinical measure Risk-adjusted standardized transfusion ratio for all adult Medicare dialysis patients. Number of observed eligible red blood cell transfusion events occurring in patients dialyzing at a facility to the number of eligible transfusions that would be expected In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey Administration, a clinical measure Facility administers, use a third-party CMS-approved vendor, the ICH CAHPS survey twice in accordance with survey specifications and submits survey results to CMS. Anemia Management Reporting, a reporting measure Number of months for which facility reports ESA dosage (as applicable) and 8

9 NQF # Measure Title and Description hemoglobin/hematocrit for each Medicare patient. Pain Assessment and Follow-Up, a reporting measure Facility reports in CROWNWeb one of six conditions for each qualifying patient once before August 1 of the performance period and once before February 1 of the year following the performance period Clinical Depression Screening and Follow-Up, a reporting measure Facility reports in CROWNWeb one of six conditions for each qualifying patient once before February 1 of the year following the performance period. NHSN Healthcare Personnel Influenza Vaccination, a reporting measure Facility submits Healthcare Personnel Influenza Vaccination Summary Report to CDC s NHSN system, according to the specifications of the Healthcare Personnel Safety Component Protocol, by May 15 of the performance period. Kt/V Dialysis Adequacy Comprehensive Clinical Measure Percentage of all patient months for patients whose average delivered dose of dialysis (either hemodialysis or peritoneal dialysis) met the specified threshold during the reporting period. NHSN Dialysis Event Reporting Measure (Proposed for PY 2019 in Section IV.C.1.a. of this Proposed Rule Payment Reductions: CMS estimates that approximately 2,840 facilities (48 percent) will receive payment QIP payment reductions in PY CMS proposes to maintain the same payment reduction methodology in PY 2020 as the one finalized for PY Estimated Distribution of PY 2020 ESRD QIP Payment Reductions Payment Reduction Number of Facilities Percent of Facilities 0.0% % 0.5% % 1.0% % 1.5% % 2.0% % Replace Mineral Metabolism Reporting Measure with Serum Phosphorous Reporting Measure: CMS proposes to replace the Mineral Metabolism Reporting Measure with Serum Phosphorous Reporting Measure using data reported from CROWNWeb. The measure is based on NQF #0255 and requires reporting once per month for each qualifying patient. The measure will require a case minimum of 11 patients. New Ultrafiltration Rate Reporting Measure: CMS proposes this new reporting measure based on monthly CROWNWeb data submissions. Facilities must report: HD Kt/V Data, Post-Dialysis Weight, Pre-Dialysis Weight, Delivered Minutes of BUN Hemodialysis, and number of sessions of dialysis delivered by the dialysis unit to the patient in the reporting month. The measure will require a case minimum of 11 patients. New Standardized Hospitalization Ratio (SHR) Measure: CMS proposes the new SHR Measure, which is an NQF-endorsed all-cause, risk-standardized rate of hospitalizations during a 1-year 9

10 observation window. The measure will be risk adjusted on 210 prevalent comorbidities in addition to the comorbidities from the CMS Medical Evidence Form 2728, but would not be adjusted for sociodemographic status. For purposes of measurement, starting with day 91 of ESRD treatment, CMS will attribute patients to a facility once the patient has been treated there for 60 days. Clinical Measure Domain Weighting: CMS proposes to revise the weights in the Clinical Measure Domain for PY 2020 to reflect policy priorities of increased emphasis on outcome and patient experience care measures, as well as the proposed addition of the proposed new Safety Measure Domain. Proposed Clinical Measure Domain Weighting for the PY 2020 ESRD QIP Measures/Measure Topics by Subdomain Measure Weight in the Clinical Domain Score (Proposed for PY 2020) Measure Weight as Percent of Total Performance Score (Proposed for PY 2020) Patient and Family Engagement / Care Coordination Subdomain 40% ICH CAHPS measure 25% 20% SRR Measure 15% 12% Clinical Care Subdomain 60% STrR measure 11% 8.8% Dialysis Adequacy measure 18% 18.8% Vascular Access Type 18% 18.8% measure topic Hypercalcemia measure 2% 1.6% (Proposed) SHR measure 11% 8.8% Performance: CMS proposes the same ESRD QIP performance standards, achievement thresholds and benchmarks policies for PY 2020 as PY 2019, with a few limited exceptions. TPS Weighting: CMS proposes to reduce the weight of the Safety Measure Domain from 15 percent in 2019 to 10 percent in 2020 in light validation concerns raised in the context of the proposal to reintroduce the NHSN Dialysis Event Reporting Measure. As a result, the Clinical Measure Domain would increase to 80 percent weight and the Reporting Measure Domain would remain at 10 percent weight. To receive a TPS score, facilities must score on at least one measure in the Clinical Measure Domain and one measure in the Reporting Measure Domain, but not the Safety Measure Domain. Comment Solicitation on Future ESRD QIP Policies: CMS is soliciting general comment on ways to refine its QIP scoring methodology to make it easier for facilities and the ESRD community to understand. Additionally CMS solicits comments on the following measures: o SRR and STrR Measures: CMS is considering a proposal to change express the Standardized Readmission Ratio (SRR) and Standardized Transfusion Ratio (STrR) measures as rates rather than ratios for ESRD QIP performance and improvement scoring. CMS is also considering reporting national performance standards and individual facility performance rates as rates, as opposed to ratios, for these measures. 10

11 o o Patient-Level Influenza Immunization Reporting: CMS is considering using ESRD Vaccination Full-Season Influenza Vaccination (MAP #XXDEFM) or NQF #0226 Influenza Immunization in the ESRD Population (Facility Level) for the QIP. CMS solicits comment on whether a future measure in this area should be collected through CROWNWeb or NHSN. Additional Future Measures: CMS solicits comment on including the following measures in the ESRD QIP in the future: (1) Standardized Mortality Ratio (SMR); (2) measure examining utilization of hospital emergency departments; (3) measure examining medication reconciliation efforts; and (4) measure examining kidney transplants in ESRD patients. Comprehensive End-Stage Renal Disease Care Model and Future Payment Models CMS solicits comment on innovative approaches to care delivery and financing for ESRD beneficiaries that would go above and beyond the Comprehensive ESRD Care (CEC) Model. The agency will use the information on financial incentives, populations or providers engaged, or the scale of change for development of future payment models and solicitation for a second round of entry into the CEC Model to begin January 1, CMS asks the following questions: 1. How could participants in alternative payment models (APMs) and advanced alternative payment models (AAPMs) coordinate care for beneficiaries with chronic kidney disease and to improve their transition into dialysis? 2. How could participants in APMs and AAPMs target key interventions for beneficiaries at different stages of chronic kidney disease? 3. How could participants in APMs and AAPMs promote better increased rates of renal transplantation? 4. How could CMS build on the CEC Model or develop alternative approaches for improving the quality of care and reducing costs for ESRD beneficiaries? 5. Are there specific innovations that are most appropriate for smaller dialysis organizations? 6. How could primary-care based models better integrate with APMs or AAPMs focused on kidney care to help prevent development of chronic kidney disease in patients and progression to ESRD? Primary-care based models may include patient-centered medical homes or other APMs. 7. How could APMs and AAPMs help reduce disparities in rates of CKD/ESRD and adverse outcomes among racial/ethnic minorities? 8. Are there innovative ways of APMs and AAPMs can facilitate changes in care delivery to improve quality of life for CKD and ESRD patients? 9. Are there specific innovations that are most appropriate for evaluating patients for suitability for home dialysis and promoting its use in appropriate populations? 10. Are there specific innovations that could most effectively be tested in a potential mandatory model? This analysis was prepared jointly in June 2016 by Mehlman Castagnetti Rosen & Thomas and Kasper Cardinale Consulting. 11

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