Je veux savoir à propos de…

lotter on DSK11XQN23PROD with RULES2

61986

Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
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 proposed that 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 proposed that kidney disease patient education services could be furnished via telehealth only by qualified staff. We noted, in the CY 2022
ESRD PPS proposed rule, that we used the terms clinical staff and qualified staff in the Specialty Care Models final rule, but did not provide definitions of these terms. For clarity, we proposed to define clinical staff and qualified staff in 42 CFR 512.310. We proposed 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 proposed 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 proposed 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 sought 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 regulations. We further sought 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
VerDate Sep<11>2014

19:07 Nov 05, 2021

Jkt 256001

specified in 410.78b3 of our regulations.
The following is a summary of the comments received on our proposed definitions of qualified staff and clinical staff, as well as our proposal to waive certain requirements for furnishing kidney disease patient education services such that they can be furnished via telehealth, and our responses.
Comment: A few commenters expressed support for the proposed definitions of clinical staff and qualified staff. One such commenter reasoned that these definitions would provide clarity on which clinicians are authorized to furnish kidney disease patient education services pursuant to the waivers implemented in the ETC
Model.
Response: We agree that the proposed definitions of clinical staff and qualified staff add clarity regarding the types of staff authorized to furnish kidney disease patient education services under the ETC Model waivers implemented in 512.397b of our regulations.
Comment: Many commenters expressed support for the use of telehealth in general, noting that telehealth is particularly good for kidney patients, especially kidney patients who live in rural areas or otherwise face barriers to accessing care.
In addition, many commenters expressed support for the specific telehealth waiver in the CY 2022 ESRD
PPS proposed rule. Two such commenters reasoned that the proposed telehealth waiver would materially increase attributed beneficiaries access to kidney disease patient education services. A few commenters who expressed support reasoned that the proposed telehealth waiver would address some barriers to access such services for attributed beneficiaries, such as lack of reliable transportation, lack of childcare, inability to take time away from work, and other socioeconomic barriers, and would afford attributed beneficiaries the choice to receive kidney disease patient education services in a location of their choice. Several commenters referenced the positive experience with and benefits of increased access to telehealth during the PHE. A few commenters expressed support for the proposed telehealth waiver because they believed it would increase the utilization of kidney disease patient education services, which they deem an important benefit.
One commenter expressed support for the proposed telehealth waiver because they believe it will both allow more
PO 00000

Frm 00114

Fmt 4701

Sfmt 4700

beneficiaries to receive kidney disease patient education services and advance health equity. Another commenter expressed support for the proposed telehealth waiver because they believe it would help address the challenge of increasing rates of kidney disease in rural areas.
Response: We appreciate the comments and support. We agree with the reasons cited by commenters in support of telehealth generally and the proposed telehealth waiver specifically.
However, because the COVID19 PHE
and the section 1135b8 waiver of geographic and site of service restrictions for telehealth originating sites in section 1834m4C of the Act are still ongoing, as described in greater detail below, we are modifying our proposal such that the proposed ETC
telehealth waiver policy will apply beginning upon the expiration of the COVID19 PHE, rather than beginning in MY3 as proposed.
Comment: One commenter expressed support for CMSs proposal to waive the requirements in Section 1834m2B
of the Act and 42 CFR 414.65b so that CMS does not pay an originating site facility fee for kidney disease patient education services furnished via telehealth at a site not specified in 410.78b3 of our regulations.
Response: We appreciate the commenters support.
Comment: One commenter expressed opposition to CMSs proposal to waive the originating site fee when telehealth services are offered under the ETC
Models telehealth waiver for kidney disease patient education services furnished via telehealth at a site not specified in 410.78b3 of our regulations. The commenter stated that the originating site fee was not waived for telehealth services furnished under the section 1135b8 telehealth waiver in effect during the COVID PHE. The commenter also stated that the inclusion of the originating site fee provides an incentive for ETC Participants to offer kidney disease patient education services via telehealth to a broader population. The commenter further noted that, consistent with the proposed incentives to increase access to alternative renal replacement modalities for dual-eligible and LIS-eligible beneficiaries under the ETC Model, allowing ETC Participants to receive the originating site fee for services furnished under the Models telehealth waivers could assist in increasing access to kidney disease patient education services for dual-eligible and LISeligible beneficiaries.
Response: While we appreciate the comment, we respectfully disagree.

E:FRFM08NOR2.SGM

08NOR2