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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
for kidney disease patient education services would align with other proposed changes to the ETC Model, which, the commenter points out, include a significant focus on health equity.
Response: We do not believe waiving the requirement that telehealth services be furnished via an interactive telecommunications system is necessary to test the ETC Model, either Modelwide or on an ETC Participant-specific basis. We believe that the telehealth waiver, as proposed, will accomplish the goal of increasing access to kidney disease patient education services, and we are interested in learning whether this goal is realized through this particular proposed waiver. While we share the concerns raised by commenters that not every beneficiary has access to an interactive telecommunications system, we are also concerned that audio-only kidney disease patient education services would not be effective in meaningfully educating beneficiaries on kidney disease. As such, we do not agree, at this time, that allowing audio-only telehealth services for kidney disease patient education services would align with CMSs focus on health equity insofar as such a policy may result in beneficiaries of lesser means systematically receiving lower quality kidney education. However, CMS will monitor the extent to which there are barriers in access to interactive telecommunciations systems among attributed beneficiaries. Based on our experience testing this telehealth waiver in the ETC Model, we may consider waiving the requirement that telehealth services be furnished via an interactive telehealth communications system, or other waivers or initiatives necessary to mitigate or eliminate barriers to accessing interactive telehealth communications systems, at a later time, either as part of the ETC Model test or in another initiative.
Final Rule Action: After considering public comments, we are finalizing our proposal in our regulation at 512.397b5 to waive geographic and site of service originating site requirements in section 1834m4B
and 1834m4C of the Act and 410.78b3 and 4 of our regulations for the purposes of kidney disease patient education services furnished by qualified staff via telehealth in accordance with 512.397, regardless of the location of the beneficiary or qualified staff, and the requirement in section 1834m2B of the Act and 414.65b of our regulations that CMS
pay a facility fee to the originating site with respect to telehealth services
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furnished to a beneficiary in accordance with 512.397 at an originating site that is not one of the locations specified in 410.78b3, with modification.
Specifically, we are modifying our proposed regulatory text at 512.397b5 to change the date on which these waivers become effective.
We are modifying both instances of the phrase, Beginning January 1, 2022, proposed in 512.397b5 to the phrase Beginning the upon the expiration of the Public Health Emergency PHE for the COVID19
pandemic.
2 Kidney Disease Patient Education Services Beneficiary Coinsurance Waiver Available data and scholarly research suggest that there is a significant relationship between socioeconomic status and prevalence of CKD. For example, evidence suggests that CKD is more prevalent among individuals with lower income.276 In addition, at least one study suggests that as an individuals CKD severity increases for example, from CKD III to CKD IV, the likelihood of the CKD patient falling into poverty increases.277 In light of this research, we stated in the CY 2022
ESRD PPS proposed rule that CMS
believes that cost represents a meaningful barrier for beneficiaries in accessing kidney disease patient education services 86 FR 36393. While we also stated that there does not appear to be any research that explicitly investigates to what extent cost barriers preclude access to kidney disease patient education services, the identified relationship between household income or poverty status and prevalence of CKD suggests that cost is an important factor when considering a beneficiarys access to kidney disease patient education services.
Under section 1833 of the Act, the amounts paid by Medicare for kidney disease patient education services are equal to 80 percent of the applicable 276 Table 1.2 in United States Renal Data System, 2020 Annual Report, Chronic Kidney Disease:
Chapter 1, CKD in the General Population, available at https adr.usrds.org/2020/chronic-kidneydisease/1-ckd-in-the-general-population indicating that the prevalence of CKD in those above the poverty line is 14.4 percent while the prevalence of CKD in those below the poverty line is 17.4 percent.
See also McClellan, W.M., et al., Poverty and Racial Disparities in Kidney Disease: The REGARDS Study, Am. J Nephrol, 2010, Volume 32, Issue 1, pages 38
46, available at https www.ncbi.nlm.nih.gov/pmc/
articles/PMC2914392/ providing data suggesting that lower household income is associated with higher prevalence of CKD.
277 Morton, R.L, et al., Impact of CKD on Household Income, Kidney International Reports, Volume 3, Issue 3, 2018, pages 610618, available at https www.sciencedirect.com/science/article/
pii/S2468024917304795?via%3Dihub.

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payment amount; beneficiaries are thus subject to a 20 percent coinsurance for kidney disease patient education services. Kidney disease patient education services can be billed under G0420 for an individual session, or under G0421 for a group session. The current national unadjusted payment for G0420 under the CY 2021 Physician Fee Schedule is $114.10; for G0421, it is $27.22. As such, a beneficiary would be required to pay $22.82 for an individual session of kidney disease patient education services or $5.44 for kidney disease patient education services furnished to a group, which may be higher or lower depending on certain factors, such as the geographic location of the beneficiary. Medicare covers up to six kidney disease patient education services for an individual beneficiary during that beneficiarys lifetime, meaning that a beneficiary may be required to pay $136.92 if six individual kidney disease patient education services are clinically appropriate for that beneficiary, or $32.64 if six group kidney disease patient education services are clinically appropriate for that beneficiary.
In the CY 2022 ESRD PPS proposed rule, we stated that we believe that it is necessary, for purposes of testing the ETC Model, to permit ETC Participants the flexibility to reduce or waive the 20
percent coinsurance requirement for kidney disease patient education services. We also stated that we believe this patient incentive would increase the provision of kidney disease patient education services to beneficiaries, given the relationship between income or poverty and prevalence of CKD, and the relationship between kidney disease patient education services and progression of CKD. In the CY 2022
ESRD PPS proposed rule, we stated that CMS had determined that, if this proposal were finalized, this CMSsponsored patient incentive would advance the ETC Models goal of increasing access to kidney disease patient education services, and to making beneficiaries more aware of their choices in preparing for kidney treatment, including the choice of receiving home dialysis, self-dialysis, or nocturnal in-center dialysis, rather than traditional in-center dialysis.
Accordingly, we proposed at 512.397c to permit, beginning January 1, 2022, ETC Participants to reduce or waive the beneficiary coinsurance obligations for kidney disease patient education services furnished to an eligible beneficiary who does not have secondary insurance on the date the kidney disease patient education services are furnished if
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