Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with RULES2

61984

Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
share aggregate data. One such commenter stated that aggregate data will help an ETC Participant determine its previous rates for different dialysis modalities, and allow the ETC
Participant to focus on increasing rates of the dialysis modalities measured for payment adjustments under the ETC
Model. The commenter further noted that without knowledge of the ETC
Participants current rates on the different modalities, the ETC Participant would have difficulty understanding when the ETC Participants actions have resulted in positive change. Another commenter noted that many small ETC
Participants may lack the resources to perform detailed analytics with the beneficiary-identifiable data, and that the proposed aggregate data would thus be helpful for such ETC Participants.
The same commenter additionally noted that the proposed aggregate data would be useful for ETC Participants that can and do perform detailed analytics with the beneficiary-identifiable data to help validate the results of such analytics.
Response: We agree that sharing the aggregate data, as proposed, would prove helpful for ETC Participants, regardless of the individual ETC
Participants analytics capacity. We also agree that such data can be used to compare the ETC Participants previous home dialysis and transplant rates, and performance with current rates and performance, and thus can help signal to the ETC Participants when interventions are producing positive results.
Comment: One commenter expressed support for our proposal to not require the ETC Participant to sign an ETC Data Sharing Agreement to obtain aggregate data from CMS.
Response: We agree; we do not believe an ETC Data Sharing Agreement is necessary to protect the aggregate data because it will be fully de-identified in accordance with HIPAA requirements under 45 CFR 164.514b and will not contain any beneficiary-identifiable data.
Comment: One commenter recommended that CMS make available aggregate comparative data to ETC
Participants quarterly to allow an ETC
Participant to assess where it stands on its home dialysis rate and transplant rate in terms of ranking relative to other ETC Participants performance.
Response: We appreciate this comment. For the same reason that we are not making beneficiary-identifiable data available on a more frequent cadence as discussed in section V.B.7.b of this final rule, we are not making aggregate data available on a more frequent cadence. Specifically, we
VerDate Sep<11>2014

19:07 Nov 05, 2021

Jkt 256001

believe that the proposed schedule for sharing aggregate data affords the ETC
Participant sufficient time to derive benefit, such as monitoring the ETC
Participants performance over the course of the ETC Model from the aggregate data. Further, as described in 512.360, CMS conducts beneficiary attribution for each month retrospectively after the end of each MY, at which time CMS calculates the ETC
Participants MPS. Accordingly, CMS
would not have aggregate data to share with the ETC Participant on a quarterly basis; CMS is unable to share aggregate data on the ETC Participants performance more often than biannually, after the end of the applicable MY.
In addition, we do not believe it is necessary for CMS to release aggregate comparative data to ETC Participants at this time. As described in 512.370b, to assess the ETC Participants achievement score, CMS assesses the ETC Participant performance at the aggregation group level against benchmarks constructed among aggregation groups of ESRD facilities and Managing Clinicians located in Comparison Geographic Areas during the Benchmark Year. The beneficiaryidentifiable data we proposed to share includes the ETC Participants MPS, and the aggregate data we proposed to share includes information on how the ETC
Participants and the ETC Participants aggregation groups scores relate to the achievement benchmark and improvement benchmark. In this way, the data CMS is already planning to share will provide the ETC Participant with insight into how the ETC
Participant and the ETC Participants aggregation group performed relative to other health care providers in the corresponding Comparison Geographic Area during the applicable Benchmark Year.
Final Rule Action: After considering public comments, we are finalizing our proposal in our regulation at 512.390b2 to share aggregate data and to specify the aggregate data that CMS would share and the process by which CMS would make available and the ETC Participant would obtain such aggregate data, without modification.
Specifically, we are finalizing our proposal to require CMS to share make aggregate data available 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.
This de-identified data includes, when available, the ETC Participants performance scores on the home dialysis rate, transplant waitlist rate, living donor transplant rate, and the
PO 00000

Frm 00112

Fmt 4701

Sfmt 4700

Health Equity Incentive; the ETC
Participants aggregation groups scores on the home dialysis rate, transplant waitlist rate, and living donor transplant rate, and the Health Equity Incentive;
information on how the ETC
Participants and ETC Participants aggregation groups scores relate to the achievement benchmark and improvement benchmark; and the ETC
Participants MPS and PPA for the corresponding PPA Period.
8. Medicare Waivers and Additional Flexibilities a. Background on Kidney Disease Patient Education Services Waiver Pursuant to section 1861ggg1 of the Act and 410.48 of our regulations, Medicare Part B covers outpatient, faceto-face kidney disease patient education services provided by certain qualified persons to beneficiaries with Stage IV
chronic kidney disease. As noted in the Specialty Care Models final rule, kidney disease patient education services play an important role in educating patients about their kidney disease and to help them make informed decisions on the appropriate type of care and/or dialysis needed for them 85 FR 61337. In addition, we noted in the Specialty Care Models final rule that kidney disease patient education services are designed to educate and inform beneficiaries about the effects of kidney disease, their options for transplantation, dialysis modalities, and vascular access 85 FR
61337. Because kidney disease patient education services have been infrequently billed, we found it necessary for purposes of testing the ETC Model to waive select requirements of kidney disease patient education services authorized in section 1861ggg1 of the Act and in the implementing regulation at 42 CFR
410.48. Specifically, to broaden the availability of kidney disease patient education services under the ETC
Model, we have used our authority under section 1115Ad of the Act to waive certain requirements for individuals and entities that furnish and bill for kidney disease patient education services. We codified these waivers at 512.397b. These include waivers to allow more types of beneficiaries to have access to kidney disease patient education services, as well as greater flexibility in how the kidney disease patient education services are performed. For instance, CMS waived the requirement that kidney disease patient education services are covered only for Stage IV chronic kidney disease CKD patients to permit beneficiaries to receive kidney disease patient education
E:FRFM08NOR2.SGM

08NOR2