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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations reasoned that, while group kidney disease patient education services sessions have minimal costs, even nominal costs can quickly add up for beneficiaries with a chronic condition, especially for beneficiaries with kidney disease, who often see multiple providers and fill multiple prescriptions each month.
Response: We agree with the commenters that, even if the coinsurance amount for group kidney disease patient education services sessions is minimal, these costs can indeed present meaningful barriers to some beneficiaries, including the beneficiaries with multiple chronic conditions and beneficiaries with kidney disease. In light of these comments, we are finalizing our proposed kidney disease patient education services coinsurance patient incentive policy to permit cost sharing support for individual or group kidney disease patient education services sessions alike.
Comment: A few commenters requested clarification relating to our statement in the CY 2022 ESRD PPS
proposed rule that we are considering prohibiting an ESRD facility or other entity from providing the ETC
Participant with qualified staff or financial support that the ETC
Participant would use in furnishing kidney disease patient education services and the proposed cost sharing support. Two such commenters requested clarification specifically on whether ESRD facilities or other entities could enter into arrangements with ETC
Participants to provide certain services at fair market value, and proposed that CMS permit such arrangements so long as the services were indeed provided at fair market value. These commenters reasoned that ESRD facilities sometimes provide physician practices with clinical staff under a personal services or other similar arrangement that complies with the Anti-Kickback Statute, the physician self-referral law, and other requirements. The commenters noted that such arrangements often occur when the dialysis facility maintains staff with pertinent expertise, such as expertise with educating patients about chronic kidney disease. These comments expressed a belief that a dialysis facility providing staffing at fair market value would not constitute providing financial support as CMS expressed concern about in the CY 2022 ESRD PPS
proposed rule, so long as the arrangement complies with all applicable fraud and abuse requirements.

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Another commenter asserted that the CY 2022 ESRD PPS proposed rule did not clarify whether CMS is considering prohibiting ESRD facilities from providing qualified staff to ETC
Participants without compensation, or whether CMS is considering prohibiting dialysis facilities from entering into a payment contract with ETC Participants to provide such services. The commenter expressed the belief that providing staff without compensation would be inappropriate and inconsistent with current fraud and abuse laws, but suggested that a prohibition on contractual payment arrangements between dialysis facilities and ETC Participants for the purpose of providing qualified staff to deliver kidney disease patient education services runs counter to CMSs goals in proposing the kidney disease patient education services coinsurance patient incentive. The commenter expressed the belief that current fraud and abuse rules, combined with the requirements CMS
currently imposes relating to kidney disease patient education services, offer sufficient protection against potentially problematic arrangements.
Response: We thank the commenters for their feedback and information. We understand that ESRD facilities and other entities sometimes enter into arrangements with clinicians or other parties to provide certain services. We recognize that some ETC Participants may wish to furnish kidney disease patient education services using staff or other resources furnished under a contractual arrangement with an ESRD
facility or other entity. We are concerned, however, that even if such arrangements are structured to comply with all applicable fraud and abuse laws, they could nevertheless result in program abuse. Specifically, such arrangements could operate to circumvent the statutory prohibition against dialysis facilities furnishing kidney disease patient education services. For example, the staff or resources furnished to the ETC
Participant from an ESRD facility or related entity could be used to market a specific ESRD facility or chain of ESRD facilities to beneficiaries who may need to choose a dialysis facility in the future.
We do not believe ETC Participants should obtain safe harbor protection for the reduction or waiver of cost-sharing on kidney disease patient education services if such services were furnished by personnel leased from an ESRD
facility or related entity. Accordingly, we are adding a provision at 512.397c1ii to require that the qualified staff furnishing the kidney
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disease patient education services for which an ETC Participant reduces or waives cost sharing must not be leased from or otherwise provided by an ESRD
facility or related entity. For purposes of this provision, a related entity would include any entity that is directly or indirectly owned in whole or in part by an ESRD facility. We believe this aligns with the statutory intent to prohibit ESRD facilities from furnishing kidney disease patient education services.
Comment: Two commenters advocated that CMS should prohibit ESRD facilities from effectively making up the financial difference an ETC
Participant would experience by waiving or reducing a beneficiarys coinsurance amount for kidney disease patient education services. One commenter recommended that CMS not finalize a prohibition on an ESRD
facility or other entity from providing financial support to enable ETC
Participants to reduce or eliminate cost sharing for kidney disease patient education services. This commenter believed that such financial support arrangements should be permitted as long as they comply with all applicable law.
Response: We agree that ESRD
facilities should not be permitted to pay ETC Participants in an effort to offset the financial impact of the ETC
Participants lost cost-sharing revenues.
We question whether the receipt of any such remuneration could comply with applicable fraud and abuse laws. Such arrangements, including those in which an entity other than an ESRD facility reimburses the ETC Participant for lost cost-sharing revenues, could result in inappropriate referrals of Federal health care program business, patient steering, corruption of medical judgment, and other abuses. Indeed, the receipt of any such remuneration could implicate and potentially violate the Federal AntiKickback statute 42 U.S.C. 1320a 7bb, and by extension the False Claims Act 31 U.S.C. 37293733 and 42
U.S.C. 1320a7bg.
Moreover, we do not believe that permitting such arrangements is necessary to test the model. We are testing a narrowly-tailored exception to the usual prohibition against the reduction or waiver of beneficiary costsharing obligations. Permitting any individual or entity other than the ETC
Participant to finance cost-sharing support is beyond the scope of the policy we are testing. Accordingly, we are persuaded that safe harbor protection for cost-sharing support furnished by ETC Participants to beneficiaries for kidney disease patient education services should be contingent
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