Quiero saber acerca de...

Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS2

payment adjustment for high-cost outliers due to unusual variations in the type or amount of medically necessary care, including variations in the amount of ESAs necessary for anemia management. As discussed in section II.B.1.c of this proposed rule, we recognize that the utilization of ESAs and other outlier services have continued to decline under the ESRD
PPS, and that we have lowered the MAP
amount and FDL amounts every year under the ESRD PPS. As discussed in the CY 2021 ESRD PPS final rule 85 FR
71439, we acknowledge that, even with annually adjusting the MAP and FDL to reflect the most recent utilization and costs of ESRD PPS eligible outlier services, total outlier payments have not yet reached the 1 percent target.
2. Current Outlier Payment Adjustment Methodology The current outlier policy was implemented in the CY 2011 ESRD PPS
final rule 75 FR 49134 through 49145
and codified at 413.237. Under 413.237, an ESRD facility will receive an outlier payment if its actual or imputed Medicare Allowable Payment MAP amount per treatment for ESRD
outlier services exceeds a threshold. The MAP amount represents the average incurred amount per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facilitys predicted ESRD outlier services MAP amount per treatment which is case-mix adjusted plus the FDL amount, set each year by CMS.298 The predicted outlier service MAP amount is the outlier MAP amount published by CMS adjusted for the case mix in the payment year; that is, it is calculated by multiplying the separately billable case mix multipliers by the outlier MAP amount. The outlier MAP
and FDL amounts are estimated using the most recent, complete data set available, which are data from 2 years prior to the payment year in question.
The predicted outlier MAPamounts and FDLs create thresholds where, if the outlier MAP amount per treatment on the claim is above the threshold, there will be a per-treatment outlier payment equal to 80 percent of the amount exceeding the threshold. The losssharing percentage was set at 80 percent in the CY 2011 ESRD PPS final rule 75
FR 49144 to make it consistent with the 298 The FDL amount is the amount by which an ESRD facilitys per-treatment Medicare allowable payment amount for furnishing ESRD outlier services to an adult/pediatric beneficiary must exceed the adult/pediatric predicted ESRD outlier services Medicare allowable payment amount to be eligible for an outlier payment.

VerDate Sep<11>2014

19:30 Jul 08, 2021

Jkt 253001

loss-sharing percentages in other Medicare payment systems.
In the CY 2011 ESRD PPS final rule and codified in 413.220b4, using 2007 data, we established the outlier percentage, which is used to reduce the per treatment base rate to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments, at 1.0 percent of total payments 75 FR 49142 through 49143.
The policy provides that the following ESRD outlier items and services are included in the ESRD PPS bundled payment: 1 Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; 2 Renal dialysis laboratory tests that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; 3 Renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; 4
Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, covered under Medicare Part D, including renal dialysis oral-only drugs effective January 1, 2025; and 5 Renal dialysis equipment and supplies that receive the transitional add-on payment adjustment as specified in 413.236 after the payment period has ended. Beginning January 1, 2021, calcimimetics became outlier services 85 FR 71405.
In the CY 2011 ESRD PPS final rule 75 FR 49064 through 49065, CMS
explained that it estimates an ESRD
facilitys costs based on most recent available data. Since the rulemaking is done in the year prior to the effective date, the most complete available data would be from the year before. This means that for CY 2022 as discussed in section II.B.1.c of this proposed rule, CMS is proposing to recalibrate the outlier MAP and FDL amounts for each calendar year using data from 2 years prior, which is the most recent and complete claims data. This methodology assumes consistent utilization over time, that is, it assumes that 2020
utilization rates for ESRD PPS outlier items and services are the same as those for 2018. However, the use of ESRD PPS
outlier items and services has in fact declined each year since the implementation of the ESRD PPS.
For example, the CY 2020 FDL
amount $48.33 for adult patients was calculated and added to the predicted MAP to determine the outlier thresholds using 2018 data. However, ESRD PPS
outlier spending continued to fall from
PO 00000

Frm 00081

Fmt 4701

Sfmt 4702

36401

2018 to 2020. Consequently, outlier payments for CY 2020 claims comprised only 0.6 percent of total ESRD PPS
payments, demonstrating that the use of 2018 data results in thresholds too high to achieve the targeted 1.0 percent outlier payment. Outlier payments for the adult population have constituted less than 1.0 percent of total ESRD PPS
payments since such payments began in 2011.299
3. Current Issue and Stakeholder Concerns As the outlier payments have consistently landed below the targeted 1.0 percent of total ESRD PPS payment threshold, stakeholders have noted that the methodology currently used to calculate the outlier results in underpayment to the providers, as money was removed from the base rate to balance the outlier payment 85 FR
71409, 71438 through 71439; 84 FR
60705 through 60706; 83 FR 56969.
Therefore, they have urged us to adopt an alternative modeling approach, one that accounts for declining trends in outlier-eligible items and services spending over time. MedPAC echoed these concerns in a comment letter in response to the CY 2021 ESRD PPS
proposed rule, where it also suggested that the introduction of calcimimetics as outlier-eligible items could perpetuate the pattern of underpayment. MedPAC
stated that if calcimimetic use decreases between 2019 when the products were paid under the ESRD PPS using the TDAPA and 2021 when the products will be paid as part of the ESRD PPS
base rate, the outlier threshold will be set too high, and outlier payments will be lower than the 1 percent of total 2021
payments.
4. Suggestions for Outlier Payment Adjustment During the second and third annual TEP meetings convened by the CMS
contractor in 2019 and 2020, panelists discussed concerns regarding the current outlier adjustment policy and alternative methodologies to achieve the 1 percent outlier target. Some TEP
panelists and stakeholders have strongly advocated that we establish a new outlier threshold using alternative modeling approaches that account for trends in separately billable spending over time. Overall, panelists expressed support for any change to outlier calculations that result in total outlier payments closer to the target.
299 Outlier percentages for the pediatric population have high variability from year to year, but have consistently met or exceeded the 1.0
percent target. The methodological modifications in this RFI do not apply to the pediatric population.

E:FRFM09JYP2.SGM

09JYP2