Federal Register - July 9, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
= 2 Higher of the home dialysis achievement or improvement score + Higher of the transplant achievement or improvement score 2 For MY3 through MY10, CMS
calculates the ETC Participants MPS as the higher of the ETC Participants achievement score for the home dialysis rate or the sum of the ETC Participants improvement score for the home dialysis rate calculated as specified in paragraph c1 of this section and, if applicable, the Health Equity Incentive, calculated as described in paragraph c2i of this section, together with the higher of the ETC Participants achievement score for the transplant rate or the sum of the ETC Participants improvement score for the transplant rate calculated as specified in paragraph c1 of this section and, if applicable, the Heath Equity Incentive, calculated as described in paragraph c2ii of this section, weighted such that the ETC
Participants score for the home dialysis rate constitutes 23 of the MPS and the ETC Participants score for the transplant rate constitutes 13 of the MPS.
CMS uses the following formula to calculate the ETC Participants MPS for MY3 through MY10:
Modality Performance Score =2
Higher of the home dialysis achievement or home dialysis improvement score + Health Equity Bonus
+ Higher of the transplant achievement or transplant improvement score + Health Equity Bonus
The Health Equity Incentive is applied to the home dialysis improvement score or transplant improvement score only if earned by the ETC
Participant.
10. Section 512.390 is amended by revising the section heading, redesignating paragraph b as c and adding new paragraph b to read as follows:
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
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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 Health Insurance Portability and Accountability Act of 1996 HIPAA regulations, and comply with the terms of the data sharing agreement described in paragraph b1iv of this section.
iv Data sharing agreement. 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 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 beneficiaryidentifable data that is a business associate of the ETC Participant or performs a similar function for the ETC
Participant, to the same terms and conditions to which the ETC Participant is itself bound in its data sharing
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agreement with CMS as a condition of the downstream recipients 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, the ETC Participant will no longer be eligible to retrieve beneficiaryidentifiable data under paragraph b1i of this section and 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:
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
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