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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
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services if they are diagnosed with CKD
Stage V or are in the first 6 months of starting dialysis to receive the benefit.
CMS also waived the requirements in section 1861ggg2Ai of the Act and 410.48a and c2i of the applicable regulations pertaining to the definition of qualified person such that registered dieticians/nutrition professionals, licensed clinical social workers, or a clinic/group practice may furnish kidney disease patient education services under the direction of, and incident to the services of a Managing Clinician who is an ETC
Participant.
Finally, CMS waived two requirements relating to the content of kidney disease patient education services furnished to a beneficiary. CMS
waived the requirement under 410.48d1 of our regulations that the content of kidney disease patient education services include the management of co-morbidities, including delaying the need for dialysis, when such services are furnished to beneficiaries with CKD Stage V or ESRD, unless such content is relevant for the beneficiary. In addition, CMS
waived the requirement under 410.48d5iii of our regulations that an outcomes assessment designed to measure beneficiary knowledge about chronic kidney disease and its treatment be performed during one of the kidney disease patient education services, requiring instead that such outcomes assessment is performed within 1 month of the final kidney disease patient education services session furnished by qualified staff.
b. Kidney Disease Patient Education Services Telehealth Waiver and Additional Flexibilities Many changes took place in 2020 and early 2021 due to the COVID19 PHE.
Legislation enacted to address the PHE
for COVID19 provided the Secretary with new authorities under section 1135b8 of the Act to waive or modify Medicare telehealth payment requirements during the PHE for COVID19. We established several flexibilities to accommodate these changes in the delivery of care. Through waiver authority under section 1135b8 of the Act, in response to the PHE for COVID19, we temporarily waived the geographic and site of service originating site restrictions in section 1834m4C of the Act. For example, CMS waived the rural area requirement at section 1834m of the Act to allow for telehealth services, including kidney disease patient education services that can be furnished via telehealth, to be furnished to
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beneficiaries in any geographic area, regardless of location and in their homes, for the duration of the PHE.
These waivers are set to terminate at the end of the COVID19 PHE.
In the CY 2022 ESRD PPS proposed rule, we stated that we believe that, once the PHE ends, these waivers removing the geographic and site of service originating site restrictions for kidney disease patient education services furnished via telehealth would be necessary solely for purposes of testing the ETC Model 86 FR 36392.
Except under very limited circumstances, under section 1834m of the Act and its implementing regulations, the originating site where the beneficiary is located at the time a telehealth service is furnished is limited to certain, mostly rural, geographic locations and a site of service that is one of certain types of health care facilities.
We also stated our belief that allowing qualified staff to furnish kidney disease patient education services via telehealth, regardless of the beneficiarys geographic area or the site of the beneficiary, and regardless of the site of service of the practitioner, would increase access to kidney disease patient education services for a few reasons.
First, some beneficiaries may not have access to reliable transportation, especially those beneficiaries who suffered economically during the ongoing PHE, but may have access to the technology necessary for practitioners to furnish kidney disease patient education services. Moreover, some beneficiaries, even those with reliable transportation, may be more comfortable receiving kidney disease patient education services via telehealth rather than appearing in person after over a year of social distancing, even when it becomes safe according to Federal guidance for such beneficiaries to enter physical spaces with other individuals. We noted that this is especially likely to be the case for instances in which a practitioner would furnish kidney disease patient education services in a group session rather than an individual session. We further noted that increasing access to kidney disease patient education services is consistent with one of the main goals of the ETC Model, insofar as we believe that education, as delivered through kidney disease patient education services, helps improve beneficiary choice of dialysis modality.
In addition, we stated that we believe that removing beneficiary cost barriers for kidney disease patient education services would be helpful. As we demonstrate below in this final rule, there is a significant relationship
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between household income or poverty status and kidney disease, and removing or mitigating cost barriers to access to kidney disease patient education services would likely increase the number of beneficiaries who would be willing to receive kidney disease patient education services.
We therefore proposed that, starting in MY3, kidney disease patient education services may be furnished to certain beneficiaries via telehealth in a manner that is more flexible than that required under existing telehealth requirements. In addition, we proposed to permit the reduction or waiver of coinsurance for the kidney disease patient education services, starting in MY3.
1 Kidney Disease Patient Education Services Telehealth Waiver CMS proposed to amend 512.397 to add a waiver of certain telehealth requirements to provide qualified staff, as we proposed to define for purposes of the ETC Model at 512.310 as described below, the flexibility to furnish kidney disease patient education services via telehealth for the reasons described above 86 FR 36392.
Specifically, we proposed to waive the geographic and site of service originating site requirements in sections 1834m4B and 1834m4C of the Act, and in our regulations at 42 CFR
410.78b3 and 4, for kidney disease patient education services furnished via telehealth. We stated, in the CY 2022
ESRD PPS proposed rule, that we believe the kidney disease patient education services telehealth waiver would allow more Medicare beneficiaries to receive kidney disease patient education services via telehealth by removing the originating site restrictions, thus allowing for the beneficiary to be located anywhere, and including at a site not specified in 410.78b3 of our regulations; and by allowing for the beneficiary to be located outside of a rural area. We also proposed to waive the requirement in section 1834m2B of the Act and 42
CFR 414.65b 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 under this proposed waiver, if finalized.
However, we did 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
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