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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules
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such Medicare payment requirements.
Under such a policy, Medicare would pay 100 percent of the payment amount for kidney disease patient education services furnished by Managing Clinicians who are ETC Participants to beneficiaries who do not have secondary insurance, and such beneficiaries would have no costsharing obligation for that benefit.
However, we determined that this policy would likely represent too large an impact to the ETC Models savings estimates, and thus would potentially jeopardize our ability to continue to test the ETC Model, if such a policy were finalized.
Given the policies proposed in this section related to programmatic waivers and additional flexibilities available under the ETC Model, we propose to modify the title of 512.397 from ETC
Model Medicare program waivers to ETC Model Medicare program waivers and additional flexibilities. We propose this change so that the section title would more accurately reflect the contents of the section if our proposed kidney disease patient education services coinsurance patient incentive is finalized.
We solicit public comments on our proposal to allow qualified staff, as we propose to define the term under 512.310, to offer coinsurance support for kidney disease patient education services to beneficiaries who are eligible for such services, including those eligible under 512.397b2, and who do not have secondary insurance on the date the kidney disease patient education services are furnished. We also solicit comment on our proposal to require the ETC Participant to maintain and provide the government with access to records regarding the use of the kidney disease patient education services coinsurance patient incentive.
3 Revising Language Providing Other ETC Model Medicare Program Waivers We propose to revise 512.397b1
through 4 in their entirety to accomplish a few goals. First, we propose to make conforming changes throughout 512.397b to the manner in which CMS discusses kidney disease patient education services. Currently, 512.397b includes references to KDE services, the KDE benefit, KDE sessions, and, simply, KDE.
CMS would change all of these references to kidney disease patient education services for clarity and to conform with the term used elsewhere in our regulations. In addition, we propose to make conforming changes through 512.397b to the manner in which CMS discusses the individuals
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who are permitted to furnish kidney disease patient education services under the ETC model programmatic waivers.
Specifically, as discussed previously, CMS is proposing to add definitions for clinical staff and qualified staff in this proposed rule, and CMS believes clarifying how CMS discusses these individuals in 512.397b will enhance clarity. Finally, CMS is proposing to remove the clinic/group practice from the list of individuals or entities that are permitted to furnished kidney disease patient education services under the ETC Model programmatic waivers, and to remove the waiver of 42 CFR
410.48c2i from 512.397b1 of this part. CMS believes that its inclusion of clinic/group practices previously was in error; a clinic/group practice is not able to furnish or bill for kidney disease patient education services under existing law and CMS did not intend for the waiver described in 512.397b to permit anyone other than a clinican to furnish kidney disease patient education services. Because the waiver of the requirements under 42 CFR
410.48c2i was implemented only to broaden the qualified person that could furnish kidney disease patient education services pursuant to 512.397b1 to include a clinic/group practice, we are proposing to remove references to 42 CFR 410.48c2i in 512.397b1 of this part.
We solicit public comments on these proposed changes to 512.397b to make conforming and clarifying changes to the manner in which CMS discusses kidney disease patient education services and the individuals who are permitted to furnish kidney disease patient education services under the ETC Model waivers described in 512.397b, and to our proposed removal of clinic/group practice from the list of individuals or entities who may, under the ETC Model waivers described in 512.397b, furnish kidney disease patient education services.
C. Requests for Information RFIs on Topics Relevant to the ETC Model This section includes several requests for information RFIs. In responding to the RFIs, the public is 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 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
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proposals. Respondents 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 respondents 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 respondents. 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.
All submissions become U.S.
Government property and will not be returned. CMS may publicly post the comments received, or a summary thereof.
1. Peritoneal Dialysis Catheter Placement The most common modality of home dialysis is peritoneal dialysis PD. In order to perform PD, a beneficiary needs placement of a PD catheter. A PD
catheter is a flexible plastic tube that enables dialysate to enter the abdomen for blood filtration purposes. The catheter is generally installed via outpatient surgery, as it is an invasive procedure.
However, CMS has heard concerns from numerous stakeholders about their ability to effectively get PD catheters installed in beneficiaries who may be otherwise interested in home dialysis.
These stakeholders reported a variety of issues related to PD catheter placement, including the lack of availability of vascular surgeons to perform PD
catheter placements, lack of appropriate operating room time, and a lack of training on PD catheter placement for vascular surgeons.287 As many stakeholders have pointed out, the lack of timely PD catheter placement is a key barrier preventing many beneficiaries from being able to use PD as a dialysis modality.
Based on these issues, we seek feedback about how CMS can test and 287 https www.ncbi.nlm.nih.gov/pmc/articles/
PMC2924406/B38.

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