Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with RULES2

61992

Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
on the ETC Participant bearing the full cost of the copayment reduction or waiver. That is, the copayment reduction or waiver may not be financed by a third party, including but not limited to an ESRD facility or related entity. Therefore, we are finalizing at 512.397c1v a new safeguard that requires the ETC Participant to bear the full cost of any cost-sharing reduction or waiver for kidney disease patient education services.
We note that we did not propose and are not finalizing any provision that would offer safe harbor protection for any arrangement between an ETC
Participant and an ESRD facility or other entity. Under this final rule, the only arrangements that may qualify for protection under the safe harbor for CMS-sponsored model patient incentives are arrangements between the ETC Participant and the beneficiary for whom the ETC Participant reduced or waived the kidney disease patient education services coinsurance amount, provided that the arrangements comply with the requirements of the safe harbor as set forth at 42 CFR 1001.952ii2
and the provisions of 512.397c1.
Comment: Several commenters, including some commenters who expressed support for CMSs proposed coinsurance patient incentive policy, suggested that CMS instead waive Medicare payment requirements such that CMS would pay the full amount of the kidney disease patient education services furnished to a beneficiary who does not have secondary insurance, rather than just 80 percent of the amount. One such commenter expressed concern that ETC Participants will not have the financial resources to forgo all or a portion of a beneficiarys coinsurance and will therefore be unable to use the flexibility afforded under this patient incentive to reduce the financial burden of beneficiaries.
Two such commenters expressed concern that while waiving coinsurance would serve to increase beneficiary use of kidney disease patient education services, ETC Participants and their qualified staff may lack willingness to provide kidney disease patient education services at a rate that, according to the commenters, would not adequately cover their costs, and that this would diminish the availability of kidney disease education to beneficiaries. Further, these commenters suggested that CMS providing the full payment amount for kidney disease patient education services would alleviate CMSs stated concern that the proposed coinsurance patient incentive could incentivize improper financial assistance from ESRD facilities and
VerDate Sep<11>2014

19:07 Nov 05, 2021

Jkt 256001

other entities. These commenters suggested that, to counterbalance CMSs stated concern that such payment waivers would result in additional Medicare costs under the ETC Model, CMS could exclude the 20 percent coinsurance amounts that CMS would cover under this alternative proposal from ETC cost calculations during the ETC Model period to determine whether this limited additional investment results in improved beneficiary quality of care and an overall cost of care reduction. Two commenters stated that CMS should pay the full amount of the kidney disease patient education services furnished to a beneficiary who does not have secondary insurance because, according to the commenters, the requirements needed to qualify for the coinsurance patient incentive are overly onerous and may present an additional barrier to access to kidney disease patient education services.
Response: We considered this alternative policy in the CY 2022 ESRD
PPS proposed rule, but concluded that it would represent too large an impact to the ETC Models potential savings 86
FR 3639436395. We believe that the policy we are finalizing, wherein an ETC Participant may reduce or waive cost sharing for kidney disease patient education services, strikes the appropriate balance in providing a new tool for ETC Participants to engage beneficiaries while also helping support the success of the Model. While a policy under which Medicare pays the full amount of the kidney disease patient education services amount, rather than 80 percent of the amount, may result in the highest number of beneficiaries receiving kidney disease patient education services, we believe that the kidney disease patient education services coinsurance patient incentive will result in more beneficiaries receiving kidney disease patient education services compared to the status quo, and will do so without detracting from the savings estimates of the ETC Model.
Moreover, we disagree with the commenters who suggested that CMS
could exclude the 20 percent coinsurance payment paid by CMS from the Models cost calculations. We cannot exclude the 20 percent coinsurance payment paid by CMS from the Models cost calculations. If we implemented the payment waiver as recommended by the commenters, CMS
would need to account for these costs when determining the Models overall impact on Medicare program expenditures. However, CMS may consider implementing a payment waiver like the alternative we
PO 00000

Frm 00120

Fmt 4701

Sfmt 4700

considered in the CY 2022 ESRD PPS
proposed rule in a future model or initiative to determine whether such an investment results in improved beneficiary quality of care and an overall cost of care reduction.
Finally, we understand the commenters concern that the proposed kidney disease patient education services coinsurance patient incentive imposes an administrative burden on ETC Participants who choose to furnish the patient incentive, but we believe that the benefits of reducing cost barriers to kidney disease patient education services through furnishing the kidney disease patient education services coinsurance patient incentive will outweigh this administrative burden. Commenters have expressed that beneficiaries who undergo kidney disease education are more likely to choose home dialysis, and to the extent this is the case, an ETC Participant that furnishes the coinsurance patient incentive might recover the direct and indirect administrative costs associated with cost-sharing waivers for such services if the ETC Participant qualifies for a positive PPA. In addition, while we agree that the alternative policy considered in the CY 2022 ESRD
PPS proposed rule would alleviate the fraud and abuse concerns we articulated in that rule, we have concluded that existing law and the safeguards finalized in this rule provide sufficient protection against such fraud and abuse.
Final Rule Action: After considering public comments, we are finalizing with modification our proposal to add 512.397c regarding an ETC
Participants ability to reduce or waive the 20 percent coinsurance obligation for kidney disease patient education services. Specifically, we are adding 512.390c1, which permits ETC
Participants to reduce or waive beneficiary cost sharing for kidney disease patient education services furnished on or after January 1, 2022 if the following conditions are satisfied: i The individual or entity that furnished the kidney disease patient education services is qualified staff; ii the qualified staff are not leased from or otherwise provided by an ESRD facility or related entity; iii the kidney disease patient education services were furnished to a beneficiary described in 410.48b or 512.397b2 who did not have secondary insurance that provides cost-sharing support for kidney disease patient education services on the date the services were furnished; iv the kidney disease patient education services were furnished in compliance with the applicable provisions of 410.48 and 512.397b; and v the
E:FRFM08NOR2.SGM

08NOR2