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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules management, more frequent laboratory testing, additional medication administration and increased educational needs. Commenters stated that patients with AKI are distinct from regular patients with ESRD in that they need specific critical treatment. CMS
continued to receive comments in response to the CY 2021 ESRD PPS
proposed rule regarding this concern, including the recommendation that CMS allow patients with AKI to be dialyzed at home. Specifically, the commenters requested that CMS allow patients with AKI to pursue peritoneal dialysis in the home if the patient and nephrologist agree it is safe to do so and the home setting is the patients choice.
We also received comments from organizations requesting that CMS
remove barriers that make it difficult for patients who want to select home dialysis. They specifically requested that, for the duration of the COVID19
PHE, CMS waive the requirement that health care providers are paid for providing care to patients with AKI only when they receive in-center hemodialysis.
The 2020 TEP included a session on AKI and the current Medicare payment system. The panelists discussed cost and utilization of AKI related dialysis services since the policy change in 2017, including the incorporation of payment for dialysis treatment for patients with AKI into the ESRD PPS, assessment of the accuracy of the reported data and the effectiveness of the current AKI payment parameters for accurately capturing the costs of this population.
Panelists agreed that some patients with AKI could benefit from different treatment regimens. In particular, they noted that more frequent, gentler dialysis would be a viable option for some patients, possibly preventing hypotension. During the COVID19
PHE, many patients received acute peritoneal dialysis treatments in the hospital upon developing AKI, and panelists expressed support for allowing patients with AKI to continue receiving acute peritoneal dialysis once they are discharged from the hospital. One panelist noted that their hospital tries to get patients with AKI accustomed to a more standard treatment regimen such as three treatments per week before discharging them to an ESRD facility.
Another panelist expressed support for the implementation of transitional care units, noting they would help patients new to dialysis adjust to dialysis and the lifestyle changes that accompany it.
Panelists also advocated for allowing patients with AKI to be treated at home,
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especially in light of the COVID19
PHE.
Members of the TEP commented on the similar treatment frequencies observed for patients with AKI and ESRD, stating that the payment system is currently constructed to facilitate the observed treatment patterns for patients with AKI. Panelists stressed that the payment system should continue to be flexible in terms of number of treatments for patients with AKI so that those who need more frequent treatments are not impeded from receiving them.
Panelists expressed support for the CMS guidance temporarily allowing dialysis facilities to send dialysis facility staff to furnish 72x dialysis to their patients in nursing homes, from both a cost and patient health perspective. See https www.cms.gov/
files/document/covid-19-emergencydeclaration-waivers.pdf. Panelists noted that it was more efficient to send ESRD facility staff to the skilled nursing facilities rather than the costly routine and ambulance-required transportation and physical isolation expenses incurred during the public health emergency. Panelists stated that the full spectrum of care provided in the SNF
setting is invaluable, particularly for the patients with multiple comorbidities.
Panelists commented on the costs per treatment observed for patients with AKI, expressing that the higher observed costs compared to ESRD treatments aligns with their expectations. Members of the panel noted that patients with AKI receive more laboratory tests to monitor for recovery, but typically are not prescribed calcimimetics or ESAs.
Some panelists also noted that due to the very small population size of Medicare beneficiaries with AKI, reporting AKI costs and statistics on cost reports at a granular level introduces an outsized reporting burden on the part of the providers.
Overall, panelists expressed that the current AKI payment structure is effective and benefits both patients and facilities. One panelist pointed out that the AKI policy change, which we implemented in the CY 2017 ESRD PPS
final rule 81 FR 77866 through 77872, helps hospitals, as they can send patients with AKI requiring dialysis to ESRD facilities and consequently free up capacity at the hospital.

ability of patients with AKI to perform home dialysis safely. We request any additional comments regarding potentially modifying site of renal dialysis services and payment for AKI in the home setting.

4. Request for Information on Modifying the Site of Services Provided to Medicare Beneficiaries With AKI
CMS is soliciting feedback from the public on the differences in care for patients with AKI versus patients with ESRD and whether it has bearing on the
1. ESRD QIPWage Estimates OMB
control numbers 09381289 and 0938
1340
To derive wages estimates, we used data from the U.S. Bureau of Labor Statistics May 2020 National Occupational Employment and Wage
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VII. Collection of Information Requirements A. Legislative Requirement for Solicitation of Comments Under the Paperwork Reduction Act of 1995, we are required to provide 60day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget OMB for review and approval. In order to fairly evaluate whether an information collection requirement should be approved by OMB, the Paperwork Reduction Act of 1995 44 U.S.C. 3506c2A requires that we solicit comment on the following issues:
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements ICRs:
B. Requirements in Regulation Text In sections V through V.B of this proposed rule, we are proposing changes to the regulatory text for the ETC Model. However, the changes that are being proposed do not impose any new information collection requirements.
C. Additional Information Collection Requirements This proposed rule does not impose any new information collection requirements in the regulation text, as specified above. However, there are changes in some currently approved information collections. The following is a discussion of these information collections.

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