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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
arrangements designed to induce or reward referrals for Federal health care program business. We solicited comments on whether this prohibition is 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. As we stated in the CY 2022 ESRD PPS
proposed rule, this is the authority under which we would waive such Medicare payment requirements. We stated that, under such a policy, Medicare would pay 100 percent of the payment amount for kidney disease patient education services furnished by Managing Clinicians who are ETC
Participants to beneficiaries who do not have secondary insurance, and such beneficiaries would have no costsharing obligation for that benefit.
However, in the CY 2022 ESRD PPS
proposed rule, we determined that this policy would likely represent too large an impact to the ETC Models savings estimates, and thus would potentially jeopardize our ability to continue to test the ETC Model, if such a policy were finalized.
Given the proposed policies related to programmatic waivers and additional flexibilities available under the ETC
Model, we proposed to modify the title of 512.397 from ETC Model Medicare program waivers to ETC Model Medicare program waivers and additional flexibilities. We proposed this change so that the section title would more accurately reflect the contents of the section if our proposed kidney disease patient education services coinsurance patient incentive is finalized.
We solicited public comments on our proposal to allow qualified staff, as we proposed to define the term under 512.310, to offer coinsurance support for kidney disease patient education services to beneficiaries who are eligible for such services, including those eligible under 512.397b2, and who do not have secondary insurance on the date the kidney disease patient
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education services are furnished. We also solicited comment on our proposal to require the ETC Participant to maintain and provide the government with access to records regarding the use of the kidney disease patient education services coinsurance patient incentive.
The following is a summary of the comments received on our proposal to allow qualified staff to offer coinsurance support for kidney disease patient education services to beneficiaries who do not have secondary insurance and our responses.
Comment: Many commenters expressed that cost is a barrier for at least some beneficiaries in accessing kidney disease patient education services.
We also received many comments expressing support for our proposal to allow an ETC Participant to reduce or waive a beneficiarys coinsurance for kidney disease patient education services furnished by qualified staff, in accordance with 512.397b1, under the ETC Model. One commenter expressed support for the proposal noting that many kidney patients have limited resources, and may choose to forgo education to dedicate such resources to obtaining medications and medical care. Another commenter similarly expressed support because they believe the proposed coinsurance patient incentive would increase access to kidney disease patient education services by removing cost barriers. Yet another commenter expressed support for the proposal, noting that coinsurance payments can burden beneficiaries, particularly those in the most underserved communities. The same commenter also expressed a belief that the proposal will advance the ETC
Models goal of increasing access to kidney disease patient education services, and of making beneficiaries more aware of their choices in preparing for kidney treatment, including the choice to receive home dialysis, selfdialysis, or nocturnal in-center dialysis, rather than traditional in-center dialysis.
Response: We agree with the reasons the commenters provided for their support, which is why we proposed and are now finalizing a policy allowing an ETC Participant to reduce or waive a beneficiarys coinsurance for kidney disease patient education services furnished by qualified staff, in accordance with 512.397b1, under the ETC Model.
Comment: A few commenters expressed opposition to our proposal to limit the proposed coinsurance patient incentive to beneficiaries without secondary insurance. One such commenter expressed that offering the
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coinsurance patient incentive to more beneficiaries would improve uptake of kidney disease patient education services, which is important given both the historically low percentage of eligible beneficiaries who have been provided kidney disease patient education services, and the important of pre-dialysis education to help beneficiaries make informed treatment decisions. Another commenter stated that, unless CMS can guarantee that Medicaid would cover the coinsurance amount for dually-eligible beneficiaries, the coinsurance patient incentive should be broadened to cover dualeligible and LIS-eligible beneficiaries, reasoning that such a proposal would ensure these groups access to appropriate education.
Response: We proposed to restrict the coinsurance patient incentive to only those beneficiaries without secondary insurance because secondary insurance typically covers this type of cost sharing. That is, providing cost sharing support would be redundant for beneficiaries with secondary coverage.
Because a beneficiarys secondary insurance will likely cover cost sharing for kidney disease patient education services, we believe our proposed policy would generally succeed in increasing access to beneficiaries by removing cost barriers for those who are obligated to pay cost sharing because it is not covered by their insurance. However, the commenter who expressed concern that Medicaid may not necessarily provide cost-sharing support for kidney disease patient education services raises an important point.
Medicaid will not necessarily cover the coinsurance amount for dual-eligible beneficiaries kidney disease patient education services, because not all Medicare Savings Programs cover Medicare coinsurance and Medicaid coverage of cost sharing generally varies by State. In some states, Medicaid would cover the cost sharing for kidney disease patient education services, while in other states it would not. In light of this State variation, and to further our stated goal of providing cost sharing support to beneficiaries who are obligated to pay cost sharing because it is not covered by their insurance, we are finalizing a policy that restricts the coinsurance patient incentive to only those beneficiaries without secondary insurance that provides cost sharing support for kidney disease patient education services.
Comment: Two commenters suggested that CMS include both individual and group kidney disease patient education services sessions in the coinsurance patient incentive. One such commenter
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