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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations 512.390 Notification, data sharing, and targeted review.

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b Data sharing with ETC
Participants. CMS shares certain beneficiary-identifiable data as described in paragraph b1 of this section and certain aggregate data as described in paragraph b2 of this section with ETC Participants regarding their attributed beneficiaries and performance under the ETC Model.
1 Beneficiary-identifiable data. CMS
shares beneficiary-identifiable data with ETC Participants as follows:
i CMS will make available certain beneficiary-identifiable data for retrieval by ETC Participants no later than one month before the start of each PPA
Period, in a form and manner specified by CMS. ETC Participants may retrieve this data at any point during the relevant PPA Period.
ii This beneficiary-identifiable data includes, when available, the following information for each PPA Period:
A The ETC Participants attributed beneficiaries names, Medicare Beneficiary Identifiers, dates of birth, dual eligible status, and LIS recipient status.
B Data regarding the ETC
Participants performance under the ETC Model, including, for each attributed beneficiary, as applicable: the number of months the beneficiary was attributed to the ETC Participant, home dialysis months, self-dialysis months, nocturnal in-center dialysis months, transplant waitlist months, and months following a living donor transplant.
iii CMS shares this beneficiaryidentifiable data on the condition that the ETC Participants observe all relevant statutory and regulatory provisions regarding the appropriate use of data and the confidentiality and privacy of individually identifiable health information as would apply to a covered entity under the regulations found at 45
CFR parts 160 and 164 promulgated under the Health Insurance Portability and Accountability Act of 1996
HIPAA, as amended, and comply with the terms of the data sharing agreement described in paragraph b1iv of this section.
iv If an ETC Participant wishes to retrieve the beneficiary-identifiable data specified in paragraph b1ii of this section, the ETC Participant must complete and submit, on at least an annual basis, a signed data sharing agreement, to be provided in a form and manner specified by CMS, under which the ETC Participant agrees:
A To comply with the requirements for use and disclosure of this beneficiary-identifiable data that are
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imposed on covered entities by the HIPAA regulations and the requirements of the ETC Model set forth in this part.
B To comply with additional privacy, security, breach notification, and data retention requirements specified by CMS in the data sharing agreement.
C To contractually bind each downstream recipient of the beneficiaryidentifiable data that is a business associate of the ETC Participant to the same terms and conditions to which the ETC Participant is itself bound in its data sharing agreement with CMS as a condition of the business associates receipt of the beneficiary-identifiable data retrieved by the ETC Participant under the ETC Model.
D That if the ETC Participant misuses or discloses the beneficiaryidentifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the data sharing agreement, CMS may deem the ETC
Participant ineligible to retrieve beneficiary-identifiable data under paragraph b1i of this section for any amount of time, and the ETC Participant may be subject to additional sanctions and penalties available under the law.
2 Aggregate data. CMS shares aggregate performance data with ETC
Participants as follows:
i CMS will make available certain aggregate data for retrieval by the ETC
Participant, in a form and manner to be specified by CMS, no later than one month before each PPA Period.
ii This aggregate data includes, when available, the following information for each PPA Period, deidentified in accordance with 45 CFR
164.514b:
A The ETC Participants performance scores on the home dialysis rate, transplant waitlist rate, living donor transplant rate, and the Health Equity Incentive.
B The ETC Participants aggregation groups scores on the home dialysis rate, transplant waitlist rate, and living donor transplant rate, and the Health Equity Incentive.
C Information on how the ETC
Participants and ETC Participants aggregation groups scores relate to the achievement benchmark and improvement benchmark.
D The ETC Participants MPS and PPA for the corresponding PPA Period.

11. Section 512.397 is amended by revising the section heading and paragraph b and adding paragraph c to read as follows:

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512.397 ETC Model Medicare program waivers and additional flexibilities.

b CMS waives the following requirements of title XVIII of the Act solely for purposes of testing the ETC
Model:
1 CMS waives the requirement under section 1861ggg2Ai of the Act and 410.48a of this chapter that only doctors, physician assistants, nurse practitioners, and clinical nurse specialists can furnish kidney disease patient education services to allow kidney disease patient education 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 kidney disease patient education service.
5 Beginning the upon the expiration of the Public Health Emergency PHE
for the COVID19 pandemic, 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
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