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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
use Medicare payment policy, under the ETC model, to promote placement of PD
catheters. Specifically, we are seeking feedback on the following questions:
What are the key barriers to increased placement of PD catheters?
How can CMS promote placement of PD catheters in a more timely manner?
Should the Innovation Center use its authority to test alternative payment structures to address the barriers to PD
catheter placement as a part of the ETC
Model? If so, why and how?

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2. Beneficiary Experience Measure The ETC Model uses two ESRD
facility quality measures; Standardized Mortality Ratio SMR NQF 0369 and Standardized Hospitalization Ratio NQF 1463. Both measures are currently calculated and displayed on Dialysis Facility Compare, a public reporting tool maintained by CMS.
Because data collection and measure reporting are ongoing through claims, there is no additional burden to ETC
Participants.
In the Specialty Care Models proposed rule, we considered including the In-Center Hemodialysis ICH
Consumer Assessment of Healthcare Providers and Systems Survey CAHPS survey to monitor beneficiary perceptions of changes in quality of care as a result of the ETC Model 84 FR
34565. However, the ICH CAHPS
survey includes only beneficiaries who receive in-center dialysis, and specifically excludes the two beneficiary populations that the ETC
Model focuses on: Beneficiaries who dialyze at home and beneficiaries who receive transplants.
We are considering the inclusion of a measure to capture the beneficiary experience of home dialysis care. The measure could be either an existing measure or one that CMS would develop. The measure could assess any aspect of the patient experience. The domains could include, but are not limited to, patient satisfaction, patient activation, and quality of life. If a new measure is developed, CMS would like to make it useful to other CMS kidney disease programs.
We seek comments on any aspect of a patient experience measure. Questions to consider include:
What domains of a patient experience of care with home dialysis would be the most useful to assess and why?
Would you prefer the measure to be newly developed or an update to an existing measure? If an update, which existing measure should be updated?

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How would a patient experience measure be best used to further the purpose of the ETC Model?
How should CMS use a patient experience measure to assess the quality of care of beneficiaries?
How should CMS use a patient experience measure to incentivize improved quality of care in the ETC
Model and/or for other CMS programs?
While we will not be responding to specific comments submitted in response to this Request for Information, CMS intends to use this input to inform our future quality measure efforts.
CMS is considering publishing the quality outcomes for the ETC Model.
While we seek comments on any aspect of reporting quality data, we specifically want input on the following:
What is the frequency with which CMS should disseminate the results?
What should be the unit of analysis for the reported data?
VI. Requests for Information This section addresses several requests for information RFIs. Upon reviewing the RFIs, respondents are encouraged to provide complete, but concise responses. These RFIs are issued solely for information and planning purposes; RFIs do not constitute a Request for Proposal RFP, application, proposal abstract, or quotation. The RFIs do not commit the United States U.S. Government to contract for any supplies or services or make a grant award. Further, CMS is not seeking proposals through these RFIs and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to these RFIs will be solely at the interested partys expense. Failing to respond to either RFI will not preclude participation in any future procurement, if conducted.
Please note that CMS will not respond to questions about the policy issues raised in these RFIs. CMS may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI
responses. Responses to these RFIs are not offers and cannot be accepted by the U.S. Government to form a binding contract or issue a grant. Information obtained because of this RFI may be used by the U.S. Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential.

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All submissions become U.S.
Government property and will not be returned. CMS may publically post the comments received, or a summary thereof.
A. Informing Payment Reform Under the ESRD PPS
Over the last several years, CMS, in conjunction with its contractor, has been conducting research, including holding three technical expert panels TEPs, to explore possible improvements to the ESRD payment model. Additionally, in the CY 2020
ESRD PPS proposed rule 84 FR 38398
through 38400, CMS invited further comment on a number of topics, including expanding the outlier policy to include composite rate drugs, laboratory tests and supplies; reporting the length of each dialysis session directly on the ESRD claim; patient characteristics which contribute significantly to the cost of dialysis care;
and improving the quality of facilitylevel data as reflected in the Medicare cost report. Stakeholders have asked CMS to explore a refined case-mix adjustment model for the ESRD PPS, stating that the existing case mix adjustors may not correlate well with the current cost of dialysis treatment.
Under section 632b of ATRA, as amended by section 217a of PAMA
and section 204 of the ABLE Act, oralonly drugs cannot be incorporated into the ESRD PPS bundled payment until January 1, 2025. In order to provide payment for oral-only renal dialysis service drugs and biologicals under the ESRD PPS beginning January 1, 2025, as provided in 42 CFR 413.174f6, we will need to propose refinements to the payment system through notice-and comment rulemaking. A refinement involves revising the patient and facility-level adjustments by changing the adjustment payment amounts based on updated regression analysis using more recent ESRD claims and cost report data. When refinements occur, due to the nature of regression analysis, all patient-level and facility-level adjustments are affected which can impact budget neutrality requirements and impact ESRD facilities differently than if adopted incrementally. Payment system changes can also require extensive efforts by CMS and health care providers to implement.
Consequently, we believe CMS and ESRD facilities would best be served if these major payment methodology changes occur as a unified approach for CY 2025.
In order to obtain additional feedback from as wide of an audience as possible, we are soliciting comments from the
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