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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
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services to be provided by clinical staff as defined at 512.310 under the direction of and incident to the services of the Managing Clinician who is an ETC Participant. The kidney disease patient education services may be furnished only by qualified staff as defined at 512.310.
2 CMS waives the requirement that kidney disease patient education services are covered only for Stage IV
chronic kidney disease CKD patients under section 1861ggg1A of the Act and 410.48b1 of this chapter to permit beneficiaries diagnosed with CKD Stage V or within the first 6
months of starting dialysis to receive kidney disease patient education services.
3 CMS waives the requirement that the content of kidney disease patient education services include the management of co-morbidities, including for the purpose of delaying the need for dialysis, under 410.48d1 of this chapter when such services are furnished to beneficiaries with CKD Stage V or ESRD, unless such content is relevant for the beneficiary.
4 CMS waives the requirement that an outcomes assessment designed to measure beneficiary knowledge about CKD and its treatment be performed as part of a kidney disease patient education service under 410.48d5iii of this chapter, provided that such outcomes assessment is performed by qualified staff within one month of the final
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kidney disease patient education service.
5 Beginning January 1, 2022, CMS
waives the geographic and site of service originating site requirements in sections 1834m4B and 1834m4C of the Act and 410.78b3 and 4 of this chapter for purposes of kidney disease patient education services furnished by qualified staff via telehealth in accordance with this section, regardless of the location of the beneficiary or qualified staff. Beginning January 1, 2022, CMS also waives the requirement in section 1834m2B of the Act and 414.65b of this chapter that CMS pay a facility fee to the originating site with respect to telehealth services furnished to a beneficiary in accordance with this section at an originating site that is not one of the locations specified in 410.78b3.
c1 Beginning January 1, 2022, an ETC Participant may reduce or waive the 20 percent coinsurance requirement under section 1833 of the Act if all of the following conditions are satisfied:
i The individual or entity that furnished the kidney disease patient education services is qualified staff.
ii The kidney disease patient education services were furnished to a beneficiary described in 410.48b or 512.397b2 who did not have secondary insurance on the date the services were furnished.
iii The kidney disease patient education services were furnished in compliance with the applicable provisions of 410.48 and 512.397b.

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2 The ETC Participant must maintain and provide the government with access to records of the following information in accordance with 512.135b and c of this part:
i The identity of the qualified staff who furnished the kidney disease patient education services for which the coinsurance was reduced or waived and the date such services were furnished.
ii The identity of the beneficiary who received the kidney disease patient education services for which the coinsurance was reduced or waived.
iii Evidence that the beneficiary who received the kidney disease patient education services coinsurance waiver was eligible to receive the kidney disease patient education services under the ETC Model and did not have secondary insurance.
iv The amount of the kidney disease patient education coinsurance reduction or waiver provided by the ETC
Participant.
3 The Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives 42 CFR
1001.952ii2 is available to protect the kidney disease patient education coinsurance waivers that satisfy the requirements of such safe harbor and paragraph c1 of this section.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202114250 Filed 7121; 4:15 pm BILLING CODE 412001P

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