Je veux savoir à propos de…

Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES2

ETC Participant bears the full cost of the waiver or reduction of the 20 percent coinsurance requirement under section 1833 of the Act and such reduction or waiver is not financed by a third party, including but not limited to an ESRD
facility or related entity.
Under new 512.397c2, we are finalizing with modification our proposed requirements regarding documentation retention and government access to records regarding the reduction or waiver of beneficiary cost-sharing obligations for kidney disease patient education services furnished under the ETC model.
Specifically, we are modifying 512.397c2iii to read, Evidence that the beneficiary who received the kidney disease patient education services coinsurance waiver was eligible to receive the kidney disease patient education services under the ETC Model and did not have secondary insurance that provides cost-sharing support for kidney disease patient education services on the date the services were furnished.
Lastly, we are finalizing without change our proposal to include at 512.397c3 a provision stating that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives is available to protect kidney disease patient education coinsurance waivers that satisfy the requirements of such safe harbor and the conditions set forth in 512.397c1.
3 Revising Language Providing Other ETC Model Medicare Program Waivers We proposed to revise 512.397b1
through 4 in their entirety to accomplish a few goals 86 FR 36395.
First, we proposed 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 proposed to make conforming changes through 512.397b to the manner in which CMS discusses the individuals who are permitted to furnish kidney disease patient education services under the ETC model programmatic waivers.
Specifically, as discussed previously, CMS proposed to add definitions for clinical staff and qualified staff in the CY 2022 ESRD PPS proposed rule, as CMS believes clarifying how CMS

VerDate Sep<11>2014

19:07 Nov 05, 2021

Jkt 256001

discusses these individuals in 512.397b will enhance clarity.
Finally, we proposed 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. We stated in the CY 2022 ESRD PPS
proposed rule that we believe that its inclusion of clinic/group practices previously was in error, and we noted that a clinic/group practice is not able to furnish or bill for kidney disease patient education services under existing law and that CMS did not intend for the waiver described in 512.397b to permit anyone other than a clinician 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 proposed to remove references to 42 CFR 410.48c2i in 512.397b1 of this part.
We solicited 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.
CMS did not receive any comments regarding the proposed conforming and clarifying changes to 512.397b of our regulations. However, we did receive some comments suggesting that CMS
make additional changes to the kidney disease patient education services waivers in 512.397b. The following is a summary of those comments and our responses.
Comment: We received a few comments asking CMS to further increase the scope of the kidney disease patient education services waivers, specifically in order to allow additional clinicians and healthcare sites to furnish kidney disease patient education services, including ESRD facilities, home dialysis nurses, and Certified Nephrology Nurses CNNs.
Response: While we understand the commenters interest in increasing even
PO 00000

Frm 00121

Fmt 4701

Sfmt 4700

61993

further the types of clinicians and entities that may furnish kidney disease patient education services under the ETC Model, we believe that our current policy provides sufficient flexibility to test the Model. Accordingly, we are not updating 512.397b at this time to add additional types of clinicians and entities that may furnish kidney disease patient education services under the Model.
Comment: We received several comments urging CMS not to grant a waiver to allow ESRD facilities to be able to bill for kidney disease patient education services, due to concerns about potential quality of education and the entrenchment of the existing dialysis market structure.
Response: We do not believe that a waiver of the requirement preventing ESRD facilities from billing for kidney disease patient education services is necessary for testing the model. ESRD
facilities are already required to provide information to beneficiaries about their treatment modality options in the ESRD
facility conditions for coverage at 494.70a7 and to develop and implement a plan of care that addresses the patients modality of care, at 494.90a7, and the costs for doing so are already included in the payment for the ESRD PPS bundled payment.
Accordingly, we are not modifying 512.397b to permit ESRD facilities to furnish kidney disease patient education services under the Model at this time.
Comment: We received a few comments expressing concern about the quality of education that beneficiaries receive as part of kidney disease patient education services and urging that CMS
create accredited curricula to ensure consistent education.
Response: We appreciate this feedback and are monitoring utilization of kidney disease patient education services to see potential effects on care.
We believe that the required content for kidney disease patient education services, as set forth in 42 CFR
410.48d, shows the minimum of what must be covered but urge interested stakeholders to consider creating a curriculum that could be used by Managing Clinicians and other qualified staff to administer kidney disease patient education services.
Comment: A few commenters suggested that CMS use its waiver authority to authorize referrals for kidney disease patient education services issued by nurse practitioners.
Two such commenters also proposed that CMS use its waiver authority to additionally authorize physician assistants and clinical nurse specialists
E:FRFM08NOR2.SGM

08NOR2