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jbell on DSKJLSW7X2PROD with PROPOSALS2

Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Proposed Rules However, we do not propose to waive the requirement under section 1834m1 of the Act and 42 CFR
410.78b that telehealth services be furnished via an interactive telecommunications system, as that term is defined in 410.78a3 to mean multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Accordingly, we would continue to require that the kidney disease patient education services furnished via telehealth be provided through an interactive telecommunications system; audio-only telehealth services would not be permitted.
We propose that kidney disease patient education services could be furnished via telehealth health only by qualified staff. We used the term clinical staff and qualified staff in the Specialty Care Models final rule, but did not provide definitions of these terms. For clarity, we now propose to define clinical staff and qualified staff in 42 CFR 512.310. We propose to define clinical staff to mean a licensed social worker or registered dietician/nutrition professional who furnishes services for which payment may be made under the physician fee schedule under the direction of and incident to the services of the Managing Clinician who is an ETC Participant. We are proposing to define the term clinical staff in this manner to describe those clinicians who are authorized to furnish kidney disease patient education services only pursuant to the waiver specified at 512.390b1namely licensed social workers and registered dieticians/nutrition professionals. The remaining clinicians currently specified in 512.390b1doctors, physician assistants, nurse practitioners, and clinical nurse specialistsfall within the existing definition of qualified person at 42 CFR 410.48a. We therefore propose to define qualified staff to mean both clinical staff and any qualified person as defined at 410.48a of our regulations who is an ETC Participant.
We seek comment on our proposal to waive the originating site requirements for telehealth services to allow qualified staff to furnish kidney disease patient education services via telehealth to a beneficiary regardless of where the beneficiary is geographically located such that kidney disease patient education services could be furnished via telehealth regardless of the beneficiarys location, including at a site not specified in 410.78b3 of our
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regulations. We further seek comment on our proposal to waive the originating site facility fee requirements such that CMS would not pay an originating site facility fee for kidney disease patient education services furnished via telehealth to a beneficiary at a site not specified in 410.78b3 of our regulations.
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.285 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.286 In light of this research, CMS believes that cost represents a meaningful barrier for beneficiaries in accessing kidney disease patient education services.
While 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 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 285 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.
286 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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G0420 under the CY2021 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.
CMS believes 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 believe this patient incentive, if finalized, 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. CMS has determined that, if this proposal were finalized, this CMS-sponsored 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, selfdialysis, or nocturnal in-center dialysis, rather than traditional in-center dialysis.
Accordingly, beginning January 1, 2022, we propose at 512.397c to permit 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 certain conditions are satisfied. We refer to this patient incentive herein as the kidney disease patient education services coinsurance patient incentive. As more fully explained below, we expect to make a determination that the antikickback statute safe harbor for CMSsponsored model patient incentives 42
CFR 1001.952ii2 would be available to protect cost-sharing support that is furnished in compliance with ETC

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