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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations First, to clarify, CMS did not propose to waive the originating site fee altogether when telehealth services are offered under the ETC Models telehealth waiver for kidney disease patient education services. That is, CMS will still pay the originating site facility fee when kidney disease patient education services are furnished via telehealth at a site specified in 410.78b3 of our regulations. This is true even if the originating site is located in a geographic area not described in 410.78b4 of our regulations, as we have waived the geographic requirements in 410.78b4 for purposes of kidney disease patient education services furnished by qualified staff via telehealth in accordance with this section, regardless of the location of the beneficiary or qualified staff.
Second, while our proposal to implement a telehealth waiver under the ETC Model was informed by the section 1135b8 telehealth waiver in effect during the COVID PHE, our proposed waiver was designed specifically for purposes of the ETC
Model. We do not believe it is appropriate, under the ETC Model, for CMS to pay an originating site facility fee to an ETC Participant when an ETC
Participant furnishes kidney disease patient education services to a beneficiary via telehealth at a site not specified in 410.78b3 of our regulations. We anticipate that when an ETC Participant is furnishing kidney disease patient education services to a beneficiary via telehealth at an originating site not specified in 410.78b3, the site will be the home of a beneficiary, or caregiver, family member, or friend of the beneficiary, or otherwise at a site not maintained by the ETC Participant. We believe this because, relative to many other Medicare services, renal replacement therapy in particular home dialysis require the involvement of a caregiver and other family and friends for support, both directly in assisting the beneficiary in learning how to perform home dialysis, and indirectly in preparing a beneficiarys residence for home dialysis such as ensuring that there is adequate space available for equipment.
When an ETC Participant is furnishing kidney disease patient education services to a beneficiary via telehealth at an originating site not specified in 410.78b3, the ETC
Participant is generally not providing administrative, clinical support, or overhead for the site where the beneficiary is located. Not paying an originating site facility fee under these
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circumstances is consistent with Medicare payment policy generally, as CMS does not pay an originating site facility fee for telehealth services furnished at an originating site that is the home of an individual.
While CMS does pay the originating site facility fee if the originating site is a patients home that has been made provider-based to a hospital during the COVID19 PHE, such a site is not technically considered the patients home. Additionally, this policy was adopted in recognition of the changes in practice patterns adopted during the PHE for infection control purposes.
CMS clarified that, during the COVID
PHE, if applicable requirements are met, a patients home may be considered a provider-based department of a hospital HOPD in recognition that when a physician or other practitioner who ordinarily practices in the HOPD
furnishes a telehealth service to a patient who is located in the home, the hospital would often still provide some administrative and technical support for the service 85 FR 27565. We do not believe this policy is appropriate for the ETC Model, as the ETC Models telehealth waiver will not become effective until the COVID19 PHE
expires, as described elsewhere in this final rule.
Third, for calendar year 2021, the payment amount for the originating site facility fee is 80% of $27.02, or $21.62.
It is possible and indeed, we hope that the telehealth waiver will increase clinically appropriate furnishing of kidney disease patient education services. We are concerned that paying the originating site facility fee for services furnished via telehealth at an originating site not specified in 410.78b3 would likely represent too large an impact on the ETC Models savings estimates, potentially jeopardizing our ability to continue to test the model. In addition, we are concerned that permitting the 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 would increase the 20
percent coinsurance owed by a beneficiary when not reduced or waived by an ETC Participant pursuant to 512.390c. The increased coinsurance obligation may dissuade a beneficiary from accessing this important service.
For these reasons, we are finalizing our proposed waiver of the requirement in section 1834m2B of the Act and 42 CFR 414.65b such that CMS will not pay an originating site facility fee for kidney disease patient education services furnished via telehealth to a
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beneficiary at a site not specified in 410.78b3 of our regulations.
Comment: One commenter expressed support for CMSs proposal to not 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.
Response: We agree that it is appropriate to continue to require that kidney disease patient education services furnished via telehealth be provided through an interactive telecommunications system, such that audio-only telehealth services are not permitted. We are concerned that audioonly kidney disease patient education services would not be effective in meaningfully educating beneficiaries on kidney disease given the complexity of the subject matter. We believe it is important that telehealth kidney disease patient education services include, or at least have the opportunity to include, images, demonstrations, and other visual cues to most effectively accomplish the objectives of kidney disease patient education services.
Comment: A few commenters expressed concern regarding our proposal to not waive the requirement under section 1834m1 of the Act and 42 CFR 410.78b that telehealth services be furnished via an interactive telecommunications system, and recommended that CMS allow the provision of audio-only telehealth services for kidney disease patient education services. Two such commenters reasoned that not every beneficiary has access to interactive telecommunications systems, and one of whom further suggested that requiring the use of video systems would preclude those beneficiaries who may most need access to kidney disease patient education services from benefiting from the proposed telehealth waiver.
The same commenter additionally suggested that CMS should give ETC
Participants the opportunity to determine how many beneficiaries would take advantage of audio-only kidney disease patient education services sessions to allow CMS to determine whether such services would represent an effective method of providing beneficiary education.
Another commenter suggested that allowing audio-only telehealth services
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