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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations proposal that the ETC Participant would be required to retrieve the beneficiaryidentifiable data in the same form and manner as the ETC Participant receives and submits the ETC Data Sharing Agreement. We also solicited comment regarding our expectation that we will use a web-based platform, rather than paper mail, for these purposes.
The following is a summary of the comments received on our proposed process for retrieving the ETC Data Sharing Agreement and beneficiaryidentifiable data, and our responses.
Comment: Two commenters expressed support for CMS making the beneficiary-identifiable data available to the ETC Participant via a web-based platform. One such commenter expressed opposition to the alternative process that CMS considered; namely, to share the beneficiary-identifiable data via paper mail, as data sent via paper mail would be inconvenient to both CMS and ETC Participants. The commenter also stated that sharing the beneficiary-identifiable data by paper mail would increase the risk of the data being viewed by the wrong parties, and that mailing data would be contradictory to CMSs initiatives promoting interoperability.
Response: We agree that a web-based platform is an appropriate process for sharing beneficiary-identifiable data in the ETC Model, and is a more appropriate process than sharing such data through paper mail. We believe, as we expressed in the CY 2022 ESRD PPS
proposed rule, that making the data available through a web-based platform would reduce administrative burden on both CMS and ETC Participants, and that a web-based platform would be more secure than making the data available through paper mail. We agree with the commenters concern that sharing data via paper mail would increase the risk of a data breach compared to sharing data via a webbased platform. While we do not believe sharing data via paper mail would necessarily contradict CMSs efforts promoting interoperability, we do believe that sharing data via paper mail would make it more burdensome for ETC Participants to ingest the data in a software that could exchange information with other healthcare providers or suppliers, or business associates, as appropriate.
Final Rule Action: After considering public comments, we are finalizing our proposal in our regulation at 512.390b that an ETC Participant must obtain an ETC Data Sharing Agreement, sign and complete an ETC
Data Sharing Agreement, and retrieve beneficiary identifiable data all in a
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form and manner to be specified by CMS, without modification. As stated in the CY 2022 ESRD PPS proposed rule, we expect that form and manner will be via a web-based platform, and CMS
will provide ETC Participants further information about this web-based platform via the ETC listserv and ETC
Model website at least one month before the first PPA Period begins on June 1, 2022.
e. CMS Sharing of Aggregate Data In addition to the proposed process for sharing beneficiary-identifiable data described previously in this section, we proposed in 512.390b2 that CMS
would 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. We proposed that this aggregate performance data, would include, when available, the following information for each PPA Period, deidentified in accordance with 45 CFR
164.514b: The ETC Participants performance scores on the home dialysis rate, transplant waitlist rate, living donor transplant rate, and, if finalized, Health Equity Incentive; the ETC Participants aggregation groups scores on the home dialysis rate, transplant waitlist rate, living donor transplant rate, and, if finalized, Health Equity Incentive; information on how the ETC Participants and ETC
Participants aggregation groups scores relate to the achievement benchmark and improvement benchmark that is, whether the ETC Participant met or exceeded the threshold for each such benchmark; and the ETC Participants MPS and PPA for the corresponding PPA Period. We stated in the CY 2022
ESRD PPS proposed rule 86 FR 36391
that we believe sharing this aggregate, de-identified data with the ETC
Participant would be important to help the ETC Participant better understand its performance in the ETC Model relative to its aggregation group and to the achievement and improvement benchmarks against which CMS is measuring the ETC Participants performance. We stated that whereas the beneficiary-identifiable data described previously in the CY 2022 ESRD PPS
proposed rule and this section of the final rule would indicate which ESRD
Beneficiaries and, if applicable, Preemptive LDT Beneficiaries the ETC
Participant could devote greater resources to, CMS believes this aggregate, de-identified data would better enable the ETC Participant to see which performance rates the ETC
Participant might need to improve to
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more generally improve its performance under the ETC Model.
We proposed that CMS would make this data available to the ETC
Participant for retrieval in a form and manner to be specified by CMS no less than one month prior to each PPA
Period. We stated that we expected that CMS would make this data available to the ETC Participant on the same webbased platform on which CMS would be providing the beneficiary-identifiable data described previously in this section. We proposed that the ETC
Participant would be required to use the form and manner specified by CMS to retrieve this aggregate data, but would not have to agree to the ETC Data Sharing Agreement to retrieve this aggregated data, as it is not beneficiaryidentifiable. We noted our belief that using a web-based platform for sharing this aggregate data would be appropriate for the same reasons it would be appropriate for sharing the beneficiaryidentifiable data. By using a web-based platform, CMS would help ensure that only authorized users would be able to obtain the data, and would be able to implement a two-factor authentication to help ensure that no one other than an ETC Participant would have access to the data. In addition, we stated, because CMS would be providing the ETC Data Sharing Agreement and beneficiaryidentifiable data on the same web-based platform, we believe it would be convenient for the ETC Participant if CMS shared the aggregate data on the same web-based platform.
In the alternative, we considered sending this aggregate data to the ETC
Participant via paper mail. However, CMS concluded in the CY 2022 ESRD
PPS proposed rule that it would be more convenient to the ETC Participant to retrieve this data from a web-based platform rather than via paper mail, and that sending this data via paper mail would represent significant administrative and operational burdens for CMS.
We solicited public comment on our proposal to share aggregate data generally, to share aggregated data in the same form and manner we are proposing to use for sharing beneficiaryidentifiable data. We also solicited public comment on our expectation to use a web-based platform for this purpose, as well as our considered alternative to share the aggregate data via paper mail.
The following is a summary of the comments received on our proposed process for sharing aggregate data, and our responses.
Comment: Some commenters expressed support for our proposal to
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