[1] See pages 119 – 165 of the unpublished rule for CMS’ discussion of these applications

CMS Proposes Pandemic Flexibilities for the ESRD Quality Incentive Program

Proposals for Payment Year 2023. Under the ESRD Quality Incentive Program (QIP), CMS assesses the total performance of each facility on measures specified for a payment year and applies an appropriate payment reduction to each facility that does not meet a minimum total performance score (TPS).

For payment year (PY) 2022, CMS finalized a measure suppression policy for the duration of the COVID-19 Public Health Emergency (PHE). CMS determined that circumstances caused by the COVID-19 PHE have significantly affected the validity and reliability of the measures and resulting performance scores. As a result, CMS is proposing to suppress the use of the following measures:

• Standardized Hospitalization Ratio (SHR) clinical measure
• Standardized Readmission Ratio (SRR) clinical measure
• In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) clinical measure
• Long-term Catheter Rate clinical measure
• Percentage of Prevalent Patients Waitlisted (PPPW) clinical measure
• Kt/V Dialysis Adequacy Comprehensive clinical measure

Additionally, due to the pandemic’s impact, CMS is proposing to use pre-pandemic data from CY 2019 to serve at the baseline period for the PY 2023 ESRD QIP.

Proposals for Payment Year 2024. Currently the Standardized Hospitalization Ratio (SHR) clinical measure and Standardized Readmission Ratio (SRR) clinical measure are calculated as a ratio but can also be expressed as a rate. Beginning in PY 2024, CMS is proposing to express both measure results as a rate. CMS proposes this change in response to comments and believes that expressing the measure results in a rate will help providers and patients to better understand a facility’s performance.

Proposals for Payment Years 2025 and 2026. For PY 2025, CMS proposes to retain the same 14 measures as the PY 2024 ESRD QIP measure set. In addition, CMS proposes:

• To change the technical measure specifications for both the SHR and SRR clinical measures to also include a covariate adjustment for patient history of COVID-19 in the previous 12 months before measure eligibility.
• To include the COVID-19 Healthcare Personnel (HCP) Vaccination reporting measure in the PY 2025 ESRD QIP measure set as a reporting measure. CMS acknowledges the importance of incentivizing and tracking HCP COVID-19 vaccination through quality measurement as a way to protect patients, healthcare workers, and caregivers. This measure would track the percentage of employed healthcare workers who are fully vaccinated at a facility. If finalized, facilities would report the measure via the Centers for Disease Control and Prevention’s National Healthcare Safety Network (NHSN) web-based surveillance system. Of note, the National Quality Forum (NQF) does not endorse the proposed COVID-19 HCP Vaccination measure.
• Beginning in PY 2025, to convert the Standardized Transfusion Ratio (STrR) Reporting measure to a clinical measure. This proposed change comes in response to commentors who had validity concerns and CMS believes the proposed STrR measure would better align with NQF measure specifications. Additionally, CMS is proposing to update the scoring methodology for this measure so that facilities that meet minimum data and eligibility requirements would receive a score based on actual clinical values from a facility—instead of on the successful reporting of data. Similar to proposed updates to the SRR and SHR clinical measures, CMS is proposing to represent the STrR measure as a rate, instead of as a ratio.
• In PY 2025, to convert the Hypercalcemia clinical measure to a reporting measure. Over the years, CMS has received public comments concerning the role and weight that the Hypercalcemia clinical measure has in the ESRD QIP. CMS is also exploring potential bone mineral metabolism replacement measures that are more effective. Additionally, CMS is proposing to update the scoring methodology for this measure so that facilities that meet minimum data and eligibility requirements would receive a score based on reporting of data—instead of actual clinical values from a facility.
• Beginning in PY 2025, to create a new domain for reporting measures and re-weighting current measure domains. Currently, ESRD QIP measures are weighted and distributed across four measure domains: Patient & Family Engagement, Care Coordination, Clinical Care, and Safety. To incentivize improving performance, CMS believes the weights on measures where there is the most room for improvement should be increased. As a result, CMS proposes a new Reporting Measure domain that would include the current four reporting measures in the ESRD QIP measure set, with the addition of the proposed COVID-19 HCP Vaccination reporting measure and the proposed Hypercalcemia reporting measure.  To accommodate this new domain, CMS proposes to update the domain and individual measure weights in the following domains: Care Coordination, Clinical Care, and Safety.

Under current policy, a facility that achieves a TPS under 55 would incur a payment reduction based on the TPS scored outlined in Table 2. CMS intended to update the TPS for PY 2025, as well as the payment reductions ranges, in the CY 2023 ESRD PPS final rule.

TABLE 2: Estimated Payment Reduction Scale for PY 2025 Based on the CY 2019 data[2]

[2] See page 251 of the unpublished rule.

CMS Proposes Changes to ESRD Treatment Choices Model

The ESRD Treatment Choices (ETC) Model[3] is an alternate payment model for the care of patients with chronic kidney disease (CKD), finalized in 2020 as part of the final rule “Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures” published on September 29, 2020 (85 FR 61114). The model tests the use of payment adjustments to encourage kidney transplants and home hemodialysis. The aim of this model is to encourage providers to invest in care coordination programs that will increase patient choice, reduce Medicare expenditures, and improve outcomes. The ETC model went into effect on January 1, 2021 and is mandatory for dialysis facilities and managing clinicians in randomly selected geographic areas across all 50 states and D.C.

• Home Dialysis Payment Adjustment (HDPA) – a positive adjustment on certain home dialysis and home dialysis-related claims during the initial 3 years of the model.
• Performance Payment Adjustment (PPA) – a positive or negative adjustment on dialysis and dialysis-related Medicare payments, for both home dialysis and in-center dialysis. This adjustment is based on ESRD facilities’ and Managing Clinicians’ rates of home dialysis, and of kidney transplant waitlisting and living donor transplantation, among attributed beneficiaries during the applicable measurement year (MY).

These adjustments are made to the adjusted ESRD PPS base rate for selected facilities and to the monthly capitation payment for selected managing clinicians. Greater positive and negative adjustments for model participants are phased in over the duration of the model.

In the CY 2022 Final Rule [4] , CMS finalized, among other things, a policy to begin stratifying achievement benchmarks in MY3 by the proportion of beneficiaries who are dual-eligible for Medicare and Medicaid or are LIS recipients to ensure that ETC Participants who see a high volume of these patients are not disproportionately negatively affected under the achievement benchmark methodology. However, CMS found that achievement benchmark stratification under this policy could increase the likelihood of the lowest benchmark being set at a home dialysis or transplant rate of zero. Therefore, CMS proposes to add a requirement that, beginning in January 1, 2023 (MY5), ETC Model participants must have a home dialysis or transplant rate greater than zero to receive an accompanying achievement score.

In addition, CMS proposes to restrict clinical staff from providing kidney disease patient education services[5] if they are leased or provided by an ESRD facility. This restriction would be in place regardless of whether the ETC Participant reduces or waives the patient’s Medicare coinsurance obligation. In the CY 2022 Final Rule, CMS added a waiver permitting ETC Participants to reduce or waive Medicare coinsurance in certain situations along with other flexibilities regarding kidney disease patient education services under the ETC Model. There, CMS specified that leased or provided qualified staff could provide kidney disease education services so long as the ETC Participant reduced or waived Medicare coinsurance obligations.

CMS believes that there is a need to better protect Medicare beneficiary care choices and limit inappropriate referrals to specific ESRD facilities and therefore proposes to add this requirement for clinical staff. CMS is also considering prohibiting the marketing of ESRD facilities in kidney disease patient education provided by clinical staff; however, the agency acknowledges that it would be difficult to enforce this prohibition unless the restriction on leased clinical staff kidney disease patient education is also finalized and therefore seeks comment on both of these proposals.

In addition, CMS intends to publish de-identified patient results from all MYs of the ETC Model, including home dialysis and transplant rate aggregate results with the identification of all ESRD facilities or managing clinicians in the aggregation group for each MY. CMS only intends to publish these rates once they are final and after the agency has resolved any timely targeted review questions.

CMS anticipates that ETC Model proposals will not impact projected direct savings alone. Overall, CMS estimates that the Model will generate $28 million in payment adjustment-related direct savings over six and a half years.

CMS Seeks Feedback on Potential ESRD Transitional Add-On Payment Adjustment

In response to patient access concerns, CMS is considering an add-on payment adjustment for renal dialysis drugs and biological products within existing ESRD functional categories after the transitional add-on payment adjustment (TDAPA) period ends. In the proposed rule, CMS outlines potential methodologies for application, which vary in terms of which formerly separately billable renal dialysis drugs and biological products would be considered for an add-on payment adjustment. CMS is seeking input on whether an adjustment is necessary, criteria for determining products to be included in the calculation, and the most appropriate methodology for implementing the adjustment. Comments will be used to inform future policy development.

CMS Seeks Feedback on Health Equity and Disparities for Pediatric ESRD Patients

CMS seeks comment on how to reduce health disparities for beneficiaries receiving renal dialysis services. CMS is interested in comments regarding comorbidities requiring representation within the case-mix adjustment, challenges to demographic data collection, and identifying underserved ESRD subpopulations.

CMS also requests comment on how CMS can detect and reduce disparities within the ESRD PPS for the pediatric patient population. Specifically, comments with supporting data on comorbidities to include in the case-mix adjuster, payment modifiers on pediatric dialysis payment claims, and suggestions for additional patient care labor categories that impact the cost of delivering pediatric dialysis services. CMS will use these comments to guide future policy development.