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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Rules and Regulations lowest estimated increase of 1.2 percent in FY 2022 payments.
This final regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 5
U.S.C. 801 et seq. and has been transmitted to the Congress and the Comptroller General for review.
I, Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on July 23, 2021.
List of Subjects in 42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below.
PART 418HOSPICE CARE
1. The authority citation for part 418
continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

2. Section 418.3 is amended by adding definitions for Pseudo-patient and Simulation in alphabetical order to read as follows:

418.3

Definitions.

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Pseudo-patient means a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the hospice aide trainee, and must demonstrate the general characteristics of the primary patient population served by the hospice in key areas such as age, frailty, functional status, cognitive status and care goals.

Simulation means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking.

3. Section 418.24 is amended by:
a. Revising paragraphs c introductory text and c9;
b. Adding paragraph c10;
c. Redesignating paragraphs d through g as paragraphs e through h; and d. Adding a new paragraph d.

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The revisions and additions read as follows:
418.24

Election of hospice care.

c Content of hospice election statement addendum. For hospice elections beginning on or after October 1, 2020, in the event that the hospice determines there are conditions, items, services, or drugs that are unrelated to the individuals terminal illness and related conditions, the individual or representative, non-hospice providers furnishing such items, services, or drugs, or Medicare contractors may request a written list as an addendum to the election statement. The election statement addendum must include the following:

9 Name and signature of the individual or representative and date signed, along with a statement that signing this addendum or its updates is only acknowledgement of receipt of the addendum or its updates and not the individuals or representatives agreement with the hospices determinations. If the beneficiary or representative refuses to sign the addendum, the hospice must document on the addendum the reason the addendum was not signed and the addendum would become part of the patients medical record. If a nonhospice provider or Medicare contractor requests the addendum, the non-hospice provider or Medicare contractor are not required to sign the addendum.
10 Date the hospice furnished the addendum.
d Timeframes for the hospice election statement addendum. 1 If the addendum is requested within the first 5 days of a hospice election that is, in the first 5 days of the hospice election date, the hospice must provide this information, in writing, to the individual or representative, nonhospice provider, or Medicare contractor within 5 days from the date of the request.
2 If the addendum is requested during the course of hospice care that is, after the first 5 days of the hospice election date, the hospice must provide this information, in writing, within 3
days of the request to the requesting individual or representative, nonhospice provider, or Medicare contractor.
3 If there are any changes to the plan of care during the course of hospice care, the hospice must update the addendum and provide these updates, in writing, to the individual or representative in order to communicate
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these changes to the individual or representative.
4 If the individual dies, revokes, or is discharged within the required timeframe for furnishing the addendum as outlined in paragraphs d1 and 2
of this section, and before the hospice has furnished the addendum, the addendum would not be required to be furnished to the individual or representative. The hospice must note the reason the addendum was not furnished to the patient and the addendum would become part of the patients medical record if the hospice has completed it at the time of discharge, revocation, or death.
5 If the beneficiary dies, revokes, or is discharged prior to signing the addendum as outlined in paragraphs d1 and 2 of this section, the addendum would not be required to be signed in order for the hospice to receive payment. The hospice must note on the addendum itself the reason the addendum was not signed and the addendum would become part of the patients medical record.

4. Section 418.76 is amended by revising paragraphs c1 and h1iii to read as follows:

418.76 Condition of participation:
Hospice aide and homemaker services.

c
1 The competency evaluation must address each of the subjects listed in paragraph b3 of this section. Subject areas specified under paragraphs b3i, iii, ix, x, and xi of this section must be evaluated by observing an aides performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a hospice aide with a patient or a pseudo-patient during a simulation.

h
1
iii If an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation of the deficient skill and all related skills in accordance with paragraph c of this section.

5. Section 418.306 is amended by revising paragraph b2 to read as follows:

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