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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
Model requirements with respect to kidney disease patient education services. If CMS makes such a determination, the safe harbor for CMSsponsored 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 are proposing 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. 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 below.
We are proposing to limit the kidney disease patient education services coinsurance patient incentive to beneficiaries who do not have secondary insurance, as secondary insurance typically provides costsharing support of the type CMS is proposing in this proposed rule. 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 costsharing support for all beneficiaries for whom kidney disease patient education services are clinically appropriate.
We are also proposing that the kidney disease patient education services 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 are proposing to include this requirement because we waived some but not all provisions of 410.48, and we believe that the requirement that the beneficiary
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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.
CMS proposes 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, we are considering limiting the kidney disease patient education services coinsurance patient incentive to kidney disease patient education services furnished to an individual beneficiary, rather than allowing the kidney disease patient education services coinsurance patient incentive for kidney disease patient education services furnished either individually or to a group. 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, 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 solicit comments on this issue.
An ETC Participant that offers coinsurance support for kidney disease patient education services would be required to maintain records of certain information. Specifically, 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 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 propose 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
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in accordance with 42 CFR 512.135b and c of this part.
We further propose 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.
In lieu of a waiver of certain fraud and abuse provisions in sections 1128A and 1128B of the Act, CMS may determine that the anti-kickback statute safe harbor CMS-sponsored model patient incentives 42 CFR 1001.952ii2 is available to protect the reduction or waiver of kidney disease patient education services coinsurance permitted under the ETC Model final rule, if issued. Specifically, 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 propose that, if we make this determination, we would specify in regulation text at 512.397c4 that the safe harbor is available.
We are also considering 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. CMS is concerned that permitting such financial support may encourage unlawful or abusive arrangements designed to induce or reward referrals for Federal health care program business. We solicit comments on whether this prohibition is a necessary to safeguard against fraud and abuse or if other laws effectively provide sufficient protection.
We also considered waiving 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. Under section 1115Ad1 of the Act, the Secretary may waive such requirements of titles XI and XVIII and of sections 1902a1, 1902a13, 1903m2Aiii of the Act, and certain provisions of section 1934 of the Act as may be necessary solely for purposes of carrying out section 1115A of the Act respect to testing models described in section 1115Ab of the Act. This is the authority under which we would waive
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