Quiero saber acerca de...

62003

Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations More than 50%

51

0.0

0.3%

0.1%

1.9%

2.3%

1 The Tablo System will be paid for using the TPNIES under the ESRD PPS for CY 2022. We estimate approximately $2.5 million in spending, of which, approximately $490,000 would be attributed to beneficiary coinsurance amounts.
2 Includes hospital-based ESRD facilities not reported to have large dialysis organization or regional chain ownership.
3 Includes ESRD facilities located in Guam, American Samoa, and the Northern Mariana Islands.

Column A of the impact table indicates the number of ESRD facilities for each impact category and column B
indicates the number of dialysis treatments in millions. The overall effect of the changes to the outlier payment policy described in section II.B.1.c of this final rule is shown in column C. For CY 2022, the impact on all ESRD facilities as a result of the changes to the outlier payment policy will be a 0.6 percent increase in estimated payments. All ESRD facilities are anticipated to experience a positive effect in their estimated CY 2022
payments as a result of the outlier policy changes.
Column D shows the effect of the annual update to the wage index, as described in section II.B.1.b of this final rule. That is, this column reflects the update from the CY 2021 ESRD PPS
wage index using 2018 OMB
delineations as finalized in the CY 2021
ESRD PPS final rule, with a basis of the FY 2022 pre-floor, pre-reclassified IPPS
hospital wage index data in a budget neutral manner. The total impact of this change is 0.0 percent; however, there are distributional effects of the change among different categories of ESRD
facilities. The categories of types of facilities in the impact table show changes in estimated payments ranging from a 0.7 percent decrease to a 0.5
percent increase due to the annual update to the ESRD PPS wage index.
Column E shows the effect of the final CY 2022 ESRD PPS payment rate update as described in section II.B.1.a of this final rule. The ESRD PPS payment rate update is 1.9 percent, which reflects the ESRDB market basket percentage increase factor for CY 2022 of 2.4
percent and the productivity adjustment of 0.5 percent.
Column F reflects the overall impact, that is, the effects of the outlier policy changes, the updated wage index, and the payment rate update. We expect that overall ESRD facilities will experience a 2.5 percent increase in estimated payments in CY 2022. The categories of types of facilities in the impact table show impacts ranging from a 1.6 percent
VerDate Sep<11>2014

19:07 Nov 05, 2021

Jkt 256001

increase to a 3.3 percent increase in their CY 2022 estimated payments.
2 Effects on Other Providers Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers for example, laboratories, durable medical equipment suppliers, and pharmacies by Medicare prior to the implementation of the ESRD
PPS. Therefore, in CY 2022, we estimate that the ESRD PPS will have zero impact on these other providers.
3 Effects on the Medicare Program We estimate that Medicare spending total Medicare program payments for ESRD facilities in CY 2022 will be approximately $8.8 billion. This estimate considers a projected decrease in fee-for-service Medicare dialysis beneficiary enrollment of 5.8 percent in CY 2022.
4 Effects on Medicare Beneficiaries Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 2.5 percent overall increase in the CY 2022 ESRD PPS
payment amounts, we estimate that there will be an increase in beneficiary co-insurance payments of 2.5 percent in CY 2022, which translates to approximately $60 million.
5 Alternatives Considered CY 2022 Impacts: 2019 Versus 2020
Claims Data Each year CMS uses the latest available ESRD claims to update the outlier threshold, budget neutrality factor, and payment rates. Due to the COVID19 PHE, we compared the impact of using CY 2019 claims against CY 2020 claims to determine if there was any substantial difference in the results that would justify potentially deviating from our longstanding policy to use the latest available data. Analysis suggested that ESRD utilization did not change substantially during the pandemic, likely due to the patients vulnerability and need for these services. Consequently, we finalized our
PO 00000

Frm 00131

Fmt 4701

Sfmt 4700

proposal to use the CY 2020 data because it does not negatively impact ESRD facilities and keeps with our longstanding policy to make updates using the latest available ESRD claims data 86 FR 36414.
Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies TPNIES
Application: The Tablo SystemHome Dialysis Machine As discussed in section II.C.1.a. of the preamble of this final rule, we are approving 1 technology for TPNIES for CY 2022, the Tablo System. We have provided an estimated impact for the purposes of the Regulatory Impact Analysis, as follows. A Tablo System that was priced at $40,000 and amortized over 5 useful life years using straight line depreciation would equal $8,000 per year $40,000/5 = $8,000.
Sixty-five percent of the annual cost would equal $5,200 per year $8,000
.65 = $5,200 per year. The pre-adjusted per treatment payment amount would equal $33.33 per treatment $5,200/156
= $33.33 per treatment. The TPNIES
amount would therefore equal an estimated $23.92 per treatment $33.33the CY 2022 average per treatment offset amount of $9.50 =
$23.83.
Based on February 2021 Shared Systems Data, there were approximately 6,600 Medicare beneficiaries receiving home hemodialysis treatment. If we estimated that this entire population were to use the Tablo System in CY2022, there would be 1,029,600
treatments 6,600 Medicare beneficiaries 156 treatments per year = 1,029,600
treatments. Applying the estimated $23.83 per treatment TPNIES amount to the estimated 1,029,600 treatments would result in approximately $25
million in spending $23.83 1,029,600
= $24,535,368. If, for example, 1
percent of this population were to use the Tablo System in CY 2022, there would be 10,296 treatments 66
Medicare beneficiaries 156 treatments per year = 10,296 treatments. Applying the $23.83 per treatment TPNIES
amount to the 10,296 treatments would result in approximately $246,280 in
E:FRFM08NOR2.SGM

08NOR2

ER08NO21.009

lotter on DSK11XQN23PROD with RULES2

BILLING CODE 412001C