Summary of Changes

PACE Summary of Change_PRA_2022_FINAL_01102022.pdf

The PACE Organization Application Process in 42 CFR Part 460 (CMS-10631)

Summary of Changes

OMB: 0938-1326

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Revision/Clarification

1. Updated Table of Contents.

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

Changes resulted in revisions to Table of Contents
pagination.

2. Global change – removed reference to “42 CFR” prior to regulatory The “purpose” statement that Global change
citations from attestations.
precedes the set of attestations
associated with each review
area in HPMS includes the full 42
CRF, Part 460 regulatory section
so it is redundant to include that
reference as part of each
regulatory provision citation
noted.

N

N

Revision/Clarification

3. Revised or added information to “General Information” and
“Instructions” areas (Sections 1 and 2, respectively).

Purpose of the
Revision/Clarification

To reinforce and clarify CMS
expectations regarding PACE
applications.

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

Sections 1 and 2

N (This is part of the
background for the
paper only; the
electronic application
does not include
Sections 1 and 2).

4. Added a row to reflect the Service Determination Process section The Service Determination
2.2 (Chart 1)
(3.8) specific to PACE. Modified the section number for all sections Process was added per updated
that follow.
PACE rule [CMS-4190-F2].

N

5. Removed sentence in NOTE under Marketing section that states:

N

The marketing module has been 3.5.B (Note)
established for a number of
years so this statement is no
“PACE organizations are no longer required to submit marketing materials longer necessary.
as a part of their application.”

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

6. Removed “accompanied by an approval letter from CMS” from the The approval letter for an
3.5.B. (Note)
following statement:
expansion application is sent to
a PACE organization
“; SAE applicants may not begin marketing in the expanded geographic area,
electronically, through HPMS. It
as applicable, until the SAE has been approved and the PACE organization
does not accompany the
has received the amended program agreement accompanied by an
updated program agreement.
approval letter from CMS.”
7. Added a sentence in the Explanation of Rights section that states:

To provide assistance to
3.6.B (Document
applicants in the development of Upload description)
their participant rights
“Please note the PACE Participant Rights template, which may be found at:
documentation by referencing a
https://www.cms.gov/Medicare/Health-Plans/PACE/Overview.”
template document available to
them.
8. Added the Service Determination Process section and 7 associated The Service Determination
3.8
attestations. Modified the section number for all sections that
Process was added per updated
follow.
PACE rule [CMS-4190-F2].

N

N

I

Revision/Clarification

9. Deleted reference to 42 CFR 460.104 from the “purpose”
statement.

10. Made revisions to the bulleted language.

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

The regulatory requirements at Section 3.9 (Purpose)
460.104 are not directly
applicable to this section and
therefore not necessary to cite.

To align with modifications per
updated PACE rule [CMS-4190F2].
11. Made revisions to the language. The attestation now indicates that Modified to account for new
participants are to be provided “written information on the appeals requirements per updated PACE
process upon enrollment, at least annually thereafter and
rule [CMS-4190-F2].
whenever the interdisciplinary team (IDT) denies a service
determination request or request for payment, . . . “ (“service
determination request replaces “request for services.”)

Section 3.9.
(Attestation No. 1)

N

N

Section 3.9 (Attestation N
No. 2)

Revision/Clarification

12. Deleted reference to appointing an appropriately credentialed
impartial third party per §460.122(c)(4). The attestation now
states:
“Applicant agrees to give all parties involved in the appeal a reasonable
opportunity to present evidence related to the dispute in person, and in
writing as specified in §460.122(d).”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

This is addressed in Attestation 3.9 (Attestation No. 3)
No. 1 so not necessary to include
in this attestation. In addition,
this requirement is distinct from
providing all parties involved in
the appeal a reasonable
opportunity to present evidence
related to the dispute per
§460.122(d).

13. Reordered certain attestations. What was originally Attestations 9- To provide a cleaner flow, i.e., to Section 3.9
11 are now NOs 6-8.
follow the order of the
(Attestations 6-8)
regulatory provisions.

N (perhaps a nominal
decrease due to removal
of redundant Language
addressed in a separate
attestation)

N

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

14. Modified former attestation No. 6 (now Attestation No. 9) to state: To align with modifications per Section 3.9 (Attestation N
updated PACE rule [CMS-4190- No. 9)
“Applicant agrees to give all parties involved in the appeal appropriate
F2].
written notification of the decision to approve or deny the appeal that
meets specified requirements at §460.122(g). “
The previous attestation language about furnishing the disputed service as
expeditiously as the participant’s health condition requires, is now
Attestation No. 10.
15. Modified previous language in Attestation No. 12.
To capture updated regulatory
requirements in §460.124
without a lot of added
specificity.

Section 3.9 (Attestation N (although slightly less
12)
verbiage)

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

16. Deleted the word “Note” from the first document upload
description (B).

Not necessary to include.

Section 3.9.B

N

17. Deleted the word “Note” from the first document upload
description (C). Also made other minor edits to the language.

To eliminate unnecessary
language.

Section 3.9.C

N (slightly less verbiage)

18. Minor wording updates to section 3.10.A, question 4 (bullets 1 and To more closely track the
3):
regulatory requirements.
Applicant agrees that the intake process minimally includes
the following activities for PACE staff and the potential
participant, representative, and/or caregiver as specified in
§460.152(a):
• Explains the PACE program, using a copy of the enrollment
agreement described in §460.154;
• Informs participant that PACE is the sole service provider;
• Informs participant that PACE guarantees access to services,
but not access to specific providers;
• Provides a list of employed and most current list of
contracted staff who deliver PACE services;
• Discloses required monthly premium if applicable;
• Discloses Medicaid spend-down obligations if applicable;
• Discloses post-eligibility treatment of income if applicable;
• Requires a signed release form from potential participant to
allow the PACE organization to obtain medical, financial, and
Medicare and Medicaid eligibility information;
• Requires assessment by the SAA to determine eligibility for
nursing facility services (NF) level of care coverage under the
State Medicaid Plan; and
• Requires assessment by the PACE staff to determine if the
potential participant can be cared for appropriately in a
community setting and that the individual meets all PACE
eligibility criteria.

Section 3.10
(Attestation No. 4)

N

Revision/Clarification

19. Added a Note to section 3.10.B that states:

Purpose of the
Revision/Clarification

This information should have
been included per previous
“Note: The policies and procedures for eligibility and enrollment must
business specifications for the
be developed in accordance with 42 CFR §460.150, §460.152,
application part of HPMS.
§460.154, §460.156, §460.158, and §460.160.”

20. Added an attestation that states the following:
“Applicant agrees that its employees or contractors do not engage in any
practice that would reasonably be expected to have the effect of steering or
encouraging disenrollment of participants due to a change in health status,
per §460.162(c).”

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

Section 3.10.
(Document upload B)

This is an important part of the Section 3.11.
regulation that should have
(Attestation No. 3)
been included previously.

N

I

Revision/Clarification

21. Added the bolded language as follows:
“Applicant agrees that involuntary disenrollment of a participant will only
be initiated for any of the following reasons as specified in §460.164(b)
and §460.164(c), and is effective on the first day of the next month that
begins 30 days after the day the PACE organization sends notice of the
disenrollment to the participant, per §460.164(a):”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

The language is an important
Section 3.11.
part of the PACE regulations and (Attestation No. 4)
needed to be specified here.

N (perhaps a slight
increase due to some
added language)

22. Updated bolded language to the purpose statement of the Required Added regulation citation
Section 3.15 (Purpose) N
Services section to the following:
§460.90 at the suggestion of
CMS audit staff because of
“The purpose of this section is to ensure that all PACE applicants provide a
instances in which PACE
benefit package for PACE participants consistent with the requirements of
organizations inappropriately
§460.90, §460.92, and §460.96. “
restrict access to services. In
part, §460.90 stipulates that
PACE participants are not
subject to limitations or
conditions relating to amount,
duration, scope of Medicare and
Medicaid services or cost
sharing.

Revision/Clarification

23. Added bolded language as follows:
“Applicant agrees to provide a PACE benefit package for all participants,
regardless of the source of payment as specified in §460.92(a), that includes
the following:”
24. Added the following attestation:

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

To explicitly reference the
Section 3.15
applicable regulatory provision. (Attestation No. 1)

To align with modifications per Section 3.15
updated PACE rule [CMS-4190- (Attestation No. 2)
“Applicant agrees that decisions by the interdisciplinary team to provide or
F2].
deny services must be based on an evaluation of the participant that takes
into account (§460.92(b)):
(1) The participant’s current medical, physical, emotional, and social needs;
and
(2) Current clinical practice guidelines and professional standards of care
applicable to the particular service.”

N

I

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

25. Deleted the first 2 bullets of Attestation No. 3 (formerly No. 2):
Removed per updated PACE rule Section 3.15
• Services not authorized by the IDT, even if a required
[CMS-4190-F2].
(Attestation No. 3
service, unless it is an emergency service;
(formerly No. 2))
• Inpatient private room and/or private duty nursing (unless
medically necessary) and non-medical items for personal
convenience (unless authorized by IDT);

D

26. Added an attestation as follows:

I

“Applicant agrees to provide a benefit package in which Medicare and
Medicaid benefit limitations and conditions relating to amount, duration,
scope of services, deductibles, copayments, coinsurance, or other cost
sharing do not apply, per §460.90(a).”

To include an important
Section 3.15
regulatory provision at §460.90 (Attestation No. 4)
not previously specified in the
application.

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

27. Added an attestation as follows:

To include an important
Section 3.15
regulatory provision at §460.90 (Attestation No. 5)
“Applicant agrees that the participant, while enrolled in the PACE program,
not previously specified in the
must receive Medicare and Medicaid benefits solely through the PACE
application.
organization, per §460.90(b).”

I

28. Updated the Service Delivery attestation to the following:

N

To align with modified language Section 3.16
per the updated PACE rule [CMS- (Attestation No. 1)
“1. Applicant agrees to be responsible for providing care that meets the
4190-F2] to emphasize that the
needs of each participant across all care settings, 24 hours a day, every day
applicant agrees to be
of the year, and must establish and implement a written plan to ensure that
responsible for providing care
care is appropriately furnished, per §460.98(a).
that meets the needs of each
participant.

Revision/Clarification

29. Added bolded language to Attestation No. 2 as follows:
“Applicant agrees to provide and oversee the provision of services as
specified in §460.98(b):”
Also modified the first bullet by adding the word “furnishing, as follows:
“• Including furnishing comprehensive medical, health, and social services
that integrate acute and long-term care in accordance with §460.98(b)(1);”
AND added bullets 3 and 4 as follows:
“•Provided as expeditiously as the participant’s health condition requires,
taking into account the participant’s medical, physical, emotional, and social
needs; and
• Document, track and monitor the provision of services across all care
settings in order to ensure the interdisciplinary team remains alert to the
participant’s medical, physical, emotional, and social needs regardless of
whether services are formally incorporated into the participant's plan of
care.”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

Revisions made to address
Section 3.16
provisions of the updated PACE (Attestation No. 2)
rule [CMS-4190-F2] at §460.98.

I

Revision/Clarification

30. Modified the introductory statement as follows (bolded language
added):
“Applicant ensures that the IDT and individual IDT members do the
following as specified in §460.102(d): “
AND modified the 4th bullet as follows:
Regularly inform the IDT of the medical, functional, and psychosocial
condition of each participant; (instead of “Communicates regularly about,
and remains alert to, . . .”
ALSO added the 3rd and 5th bullets:
“• Document all recommendations for care or services and the reason(s)
for not approving or providing recommended care or services, if applicable,
in accordance with §460.210(b).”
• Remain alert to pertinent input from any individual with direct knowledge
of or contact with the participant, including the following: (A) Other team
members; (B) Participants; (C) Caregivers; (D) Employees; (E) Contractors;
(F) Specialists; (G) Designated representatives; and”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

To align with modified language 3.18 (Attestation No. 4) I
per the updated PACE rule [CMS4190-F2]

Revision/Clarification

31. Modified the language as follows:
“Applicant agrees to establish written policies and implement procedures
to safeguard the privacy of any information that identifies a particular
participant consistent with the requirements for confidentiality per
§460.200(e).”
32. Added a section (§) to the regulatory provision cited in the
introductory statement (§460.104(b)).

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

To more closely reflect the
regulatory requirements.

Section 3.18
(Attestation No. 5)

N

For consistency purposes

Section 3.19
(Attestation No. 2)

N

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

33. Modified introductory statement as follows (bold language added): Change to introductory
Section 3.19
statement to be cleaner and to (Attestation No. 6)
“Applicant ensures that the IDT conducts unscheduled
point to specific regulatory
reassessments per requirements at §460.104(d):”
provision addressed in
attestation.
ALSO revised the second bullet to read as follows:
“• In response to a service determination request the PACE organization
expects to deny or partially deny, in accordance with §460.121(h).”

Modified bulleted language to
incorporate the new service
determination request
requirement at §460.121 per the
updated PACE rule [CMS-4190F2].

N

Revision/Clarification

34. Deleted reference to 42 CFR §460.104(d)(2) from the following
statement:
“Applicant ensures that there are explicit procedures for performance of
unscheduled reassessments as specified in 42 CFR §460.104(d)(1) and 42
CFR §460.104(d)(2).”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

This regulatory provision was
Section 3.19
modified per the updated PACE (Attestation No. 8)
rule [CMS-4190-F2 to indicate
that unscheduled reassessments
may be conducted in response
to a service determination
request. This specific provision
is now captured separately, as
part of Attestation No. 6 as well
as in separate requirements that
address service determination
requests per §460.121.

N (nominal change to
verbiage)

Revision/Clarification

35. Revised the language as follows (bolded language added):
“Applicant ensures data collection, record maintenance, and report
submission as required by CMS and the SAA per §460.200(a).”

36. Revised the language as follows (bolded language added):
“Applicant ensures CMS and SAA access to data and records per
§460.200(b) including, but not limited to:”
37. Added the following attestation:

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

To point to specific regulatory
provision addressed in
attestation.

3.27 (Attestation No. 1) N

To point to specific regulatory
provision addressed in
attestation.

3.27 (Attestation No. 2) N

To mirror the language in the
Section 3.27
updated PACE rule [CMS-4190- (Attestation No. 3)
“Applicant ensures CMS and the SAA are able to obtain, examine or retrieve
F2].
participant health outcomes data, which may include reviewing information
at the PACE site or remotely, and agrees that this may entail uploading or
electronically transmitting information, or sending hard copies of required
information by mail, per §460.200(b)(2).”

I

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

38. Revised introductory language as follows (bolded language added): To point to specific regulatory
provision addressed in
“Applicant ensures written policies and implementation of procedures to
attestation.
safeguard data, books and records against the following, as specified in
§460.200(d)(1):

Section 3.27
(Attestation No. 4)

N

39. Revised introductory language as follows (bolded language added): To point to specific regulatory
provision addressed in
“Applicant ensures confidentiality of health information, per §460.200(e),
attestation.
through policies and procedures that do the following:”

Section 3.27
(Attestation No. 5)

N

40. Revised introductory language as follows (bolded language added): To point to specific regulatory
provision addressed in
“Applicant ensures retention of records, per §460.200(f), for the longest of
attestation.
the following periods:”

Section 3.27
(Attestation No. 6)

N

Revision/Clarification

41. Revised language as follows (bolded language added):
“Applicant agrees to maintain a single, comprehensive medical record for
each participant, in accordance with accepted professional standards, as
specified in §460.210(a).”

42. Added the following attestation:
“Applicant ensures that the medical record contains, at a minimum, all
required components specified in §460.210(b).”

Purpose of the
Revision/Clarification

To point to specific regulatory
provision addressed in
attestation.

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

3.28 (Attestation No.
1)

Added to address added
3.28 (Attestation No.
requirements language in the
3)
updated PACE rule [CMS-4190F2].

N

I

Revision/Clarification

43. Revised language as follows (bolded language added):
“Applicant agrees to promptly transfer copies of pertinent medical record
information between treatment facilities, per §460.210(c).”

44. Revised language as follows (bolded language added):
“Applicant's medical records are appropriately authenticated, per
§460.210(d), by ensuring the following:
• All entries are legible, clear, complete, and appropriately authenticated
and dated; and, . . .”

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

Language modified to align with 3.28 (Attestation No.
language in the regulatory
4)
provision.

N

To point to specific regulatory
provision addressed in
attestation.

N

Replaced “must have” with “are”
in bulleted language to better
follow the introductory
statement.

3.28 (Attestation No.
5)

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

45. Revised language as follows (bolded language added):

The reference to the regulatory Section 3.30 (Purpose N
citation was originally a
Statement)
“The purpose of this section is to ensure that the state is willing to enter
parenthetical. Modified to
into a PACE program agreement with the applying entity, or, as applicable,
incorporate as part of the
is willing to amend the program agreement with a PACE organization
purpose statement by deleting
applying to expand its service area and/or add a PACE center site, and that
the open and close parens and
it has processes in place to ensure compliance with its obligations under the
adding the word “at”.
program at 42 CFR §460.12 (b).”
46. Revised language as follows (bolded language added):
“In the documents section upload a description of the state’s process for
enrollment of participants into the state system, per §460.182(d), including
the criteria for deemed continued eligibility for PACE in accordance with
460.160(b)(3).”

To point to specific regulatory
provision addressed in
attestation.

Section 3.30 (Upload
document E)

N

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

47. Revised language as follows (bolded language added):

To specify that the criteria are Section 3.29 (Upload
designated by the State
document F)
“In the documents section upload a description of the state’s process to
Administering Agency (SAA).
oversee the applicant’s administration of the SAA’s criteria for determining The regulatory citations are
if a potential PACE enrollee is safe to live in the community at the time of included to point to specific
enrollment, per §460.150(c) and §460.152(b).”
regulatory provisions addressed
in the attestation.

48. Revised language as follows (bolded language added):
“In the documents section upload a description of the state’s process for
disenrollment of participants from the state’s system, per §460.182(d), as
well as the process for prior review of involuntary disenrollments in
accordance with §460.164(f).”

Language added to point to
Section 3.29.H
specific regulatory provisions
addressed in the attestation and
to specifically reference the
requirement at §460.164(f).

N

N

Revision/Clarification

Purpose of the
Revision/Clarification

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

49. Added a statement to the instructions for the Explanation of Rights To provide additional instruction Section 4.4
upload (bolded language added):
to the applicant by pointing to a
template document that
“(Instruction: Include a description of the Participant Bill of Rights. This
provides current requirements.
must be consistent with the requirements at 42 CFR §460.110, §460.112,
§460.116, and §460.118. Refer to the PACE Participant Rights template
document, which includes current requirements, at:
https://www.cms.gov/Medicare/Health-Plans/PACE/Overview.)”

N

50. Modified the instructions for the Additional Appeals Rights section To clearly state that we want a Section 4.11
(bolded language added):
PACE applicant’s policy on
additional appeal rights and not
“(Instructions: Describe policies and procedures regarding (deleted
just the policy for informing
”informing”) participants’ (deleted “of their”) additional appeals rights
participants. Last part added to
under Medicare and/or Medicaid. Note: This process must be developed in
provide important instruction to
accordance with 42 CFR §460.124, including the process for filing any
applicants.
further appeals, and should specify whether the timeframes for
responding to appeals are calendar days or business days.)”

N

Revision/Clarification

Purpose of the
Revision/Clarification

51. Modified language in the State Attestations/Assurances Signatures To provide added clarity to
Pages document to state the following (bolded language added):
applicants and states in
completing this required form.
Service area specific to this application (deleted “by county or zip codes, as
applicable”). (Include name of each applicable county and specify either
full or partial for each. If partial, list all applicable zip codes specific to that
county. For expansion applications, only enter the new service area being
added.) ___________________________________________________
(Deleted “(if an expansion application, only enter the new service area being
added.) “

Level of
Applicant
2023 PACE Application Burden I = Increases
Section
burden
D – Decreases burden
N – No
Change

4.20

N


File Typeapplication/pdf
File TitlePACE Paper Application
AuthorKelli McDermott
File Modified2022-01-13
File Created2022-01-10

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