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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations certain conditions are satisfied. We refer to this patient incentive herein as the kidney disease patient education services coinsurance patient incentive.
We stated in the CY 2022 ESRD PPS
proposed rule that we expected to make a determination that the anti-kickback statute safe harbor for CMS-sponsored model patient incentives 42 CFR
1001.952ii2 would be available to protect cost-sharing support that is furnished in compliance with ETC
Model requirements with respect to kidney disease patient education services. We noted that if CMS were to make such a determination, the safe harbor for CMS-sponsored model patient incentives would protect an ETC
Participant, as that term is defined at 512.310, who offers a reduction or waiver of coinsurance for kidney disease patient education services to beneficiaries who are eligible to receive kidney disease patient education services, including those eligible pursuant to the waiver described in 512.397b2, and who do not have secondary insurance on the date that the kidney disease patient education services were furnished.
We proposed that the kidney disease patient education services coinsurance patient incentive would be available to the ETC Participant for kidney disease patient education services furnished by an individual or entity who is qualified staff. We stated that this proposal would align with the individuals who may furnish kidney disease patient education services under 512.397b of this subpart, which are we replacing in its entirety to standardize certain terms and add clarity, as described in greater detail in the CY 2022 ESRD PPS
proposed rule and in section VIII.b.3 of this final rule.
We proposed to limit the kidney disease patient education services coinsurance patient incentive to beneficiaries who do not have secondary insurance, because secondary insurance typically provides costsharing support of the type CMS
proposed in the CY 2022 ESRD PPS
proposed rule. In the CY 2022 ESRD
PPS proposed rule, we stated that we also believe that limiting the kidney disease patient education services coinsurance patient incentive to beneficiaries without secondary insurance would better ensure that only beneficiaries who need cost-sharing support would receive it, rather than permitting cost-sharing support for all beneficiaries for whom kidney disease patient education services are clinically appropriate.
We also proposed that the kidney disease patient education services
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coinsurance patient incentive would be available only for kidney disease patient education services that were furnished in compliance with the applicable provisions of 410.48 of our regulations, which includes a requirement that a beneficiary obtain a referral from the physician as defined in section 1861r1 of the Act managing the beneficiarys kidney condition in order for the beneficiary to be eligible to receive kidney disease patient education services. We proposed to include this requirement because we waived some but not all provisions of 410.48, and because, as stated in the CY 2022 ESRD PPS proposed rule, we believe that the requirement that the beneficiary receive a referral from their physician is important for ensuring that kidney disease patient education services are furnished only to beneficiaries for whom it is clinically appropriate.
We proposed that such coinsurance support would be permitted for the kidney disease patient education services offered either in-person or via telehealth, and that it would be permitted for both individual sessions and group sessions. However, in the CY
2022 ESRD PPS proposed rule we considered limiting the coinsurance support to kidney disease patient education services that are furnished to an individual beneficiary, rather than allowing the coinsurance support for such services furnished either individually or to a group. We noted that the cost burden on beneficiaries who receive kidney disease patient education services in a group setting is much lower than it is on beneficiaries who receive kidney disease patient education services individually.
However, as we stated in the CY 2022
ESRD PPS proposed rule, we are concerned that any cost barrier to kidney disease patient education services, even if low, represents a meaningful barrier to some beneficiaries who would otherwise elect to receive such services. We solicited comments on this issue.
We proposed that an ETC Participant that offers coinsurance support for kidney disease patient education services would be required to maintain records of certain information.
Specifically, we proposed that an ETC
Participant that offers the kidney disease patient education services coinsurance patient incentive would be required to maintain records of the following: The identity of the qualified staff who furnished the kidney disease patient education services for which the coinsurance was reduced or waived; the date the kidney disease patient
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education services coinsurance patient incentive was provided; the identity of the beneficiary to whom the kidney disease patient education services coinsurance patient incentive was provided; evidence that the beneficiary who received the kidney disease patient education services coinsurance patient incentive was eligible to receive the kidney disease patient education services and did not have secondary insurance; and the amount of the kidney disease patient education services coinsurance patient incentive reduced or waived by the ETC Participant. We proposed to require an ETC Participant that offers this kidney disease patient education services coinsurance patient incentive to maintain and provide the government with access to these records in accordance with 42 CFR 512.135b and c.
We further proposed in proposed 42
CFR 512.160b6ii that, for the ETC
Model only, CMS could suspend or terminate the ability of an ETC
Participant to offer the kidney disease patient education services coinsurance patient incentive if CMS determined that any grounds for remedial action exist pursuant to 512.160a.
We stated in the CY 2022 ESRD PPS
proposed rule that, in lieu of a waiver of certain fraud and abuse provisions in sections 1128A and 1128B of the Act, CMS may determine that the antikickback statute safe harbor CMSsponsored model patient incentives 42
CFR 1001.952ii2 is available to protect the reduction or waiver of coinsurance for kidney disease patient education services permitted under the ETC Model final rule, if issued. We stated in the CY 2022 ESRD PPS
proposed rule that we expect to determine that the CMS-sponsored model safe harbor will be available to protect the reduction or waiver of coinsurance that satisfies the requirements of such safe harbor and the provisions of proposed 512.397c1. We proposed that, if we make this determination, we would specify in regulation text at 512.397c4 that the safe harbor is available.
We also considered, in the CY 2022
ESRD PPS proposed rule, prohibiting on an ESRD facility or other entity from providing qualified staff or the ETC
Participant with financial support to enable such qualified staff or ETC
Participant to provide the kidney disease patient education services coinsurance patient incentive. As we stated in the CY 2022 ESRD PPS
proposed rule, CMS is concerned that permitting such financial support may encourage unlawful or abusive
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