Federal Register - November 8, 2021
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Fuente: Federal Register
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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
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qualified staff. Beginning the upon the expiration of the Public Health Emergency PHE for the COVID19
pandemic, 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 of this chapter.
c1 For kidney disease patient education services furnished on or after 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 qualified staff are not leased from or otherwise provided by an ESRD
facility or related entity.
iii The kidney disease patient education services were furnished to a beneficiary described in 410.48b or 512.397b2 who did not have
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secondary insurance that provides costsharing support for kidney disease patient education services on the date the services were furnished.
iv The kidney disease patient education services were furnished in compliance with the applicable provisions of 410.48 and 512.397b.
v The ETC Participant bears the full cost of the reduction or waiver of the 20
percent coinsurance requirement under section 1833 of the Act. The reduction or waiver of the 20 percent coinsurance requirement under section 1833 of the Act shall not be financed by a third party, including but not limited to an ESRD facility or related entity.
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:
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
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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 that provides costsharing support for kidney disease patient education services.
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.
Dated: October 28, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
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