Response to Comment Document /Summary of Change (Crosswalk)

Crosswalk/Summary of Change Based on 60-day Comments and CMS Response for
PRA Package (CMS-10631 Electronic PACE Application)
Comment

CMS Response to Comment

1. Comment from National PACE Association with support
from other commenters:
Commenters recommended allowing multiple expansion
applications to be submitted and under review by CMS at the
same time. (CMS does not allow PACE organizations to
submit an expansion application if one is currently pending.)

Recommendation not accepted. The
recommendation to allow PACE
organizations to have more than one
pending application at a time is
outside the scope of this information
collection. However, it should be
noted that this recommendation has
been considered by CMS and
addressed through other channels.

N/A

N

2. Comment from PACE Southeast Michigan:
Recommended further streamlining that process to allow POs
to submit one application for two centers that will be
opened within one year.

This is allowable currently as part of
the application process.

N/A

N

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

Comment

CMS Response to Comment

3. Comment from National PACE Association with support
from other commenters:
In the absence of being able to have more than one
expansion application under review concurrently,
commenters recommend that CM allow a PO seeking to
expand its geographic service area when another application
is pending to opt to establish a new contract if such
application has the support of its SAA.

The suggestion is outside the scope
of this information collection. That
said, CMS notes that a single, PACE
organization-specific program
agreement, which serves as the
binding contract between CMS, the
PO and the State Administering
Agency, provides the essential basis
for the operations of the PO. The
suggestion would result in multiple
program agreements specific to a
single PO and, depending on the
timing of submission and review of
that organization’s expansion
applications, would, over time, likely
result in varying program agreement
information applicable to a single
entity, which would be cumbersome
and confusing for all parties involved.

PACE
Application
Section

N/A

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change
N

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Comment

CMS Response to Comment

4. Comment from National PACE Association with support
from other commenters:
Commenters recommended having distinct applications
specific to type of expansion application (meaning different
applications that involve adding a PACE center site to the
existing approved service area and those that involve only a
geographic expansion).

Recommendation not accepted. CMS
addressed the need for utilizing the
same application for initial and
expansion applications as part of the
previous information collection cycle.
In addition to serving as a
qualification tool, the application
process facilitates approval of the
amended program agreement upon
approval of the SAE application
(regardless of type) and provides a
means to capture information
consistently.

PACE
Application
Section

N/A

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change
N

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Comment

CMS Response to Comment

5. Comment from National PACE Association with support
from other commenters:
Commenters recommended that CMS not require expansion
applications to upload documents that have not been altered
in any way since CMS’ approval of a previous application.

Recommendation not accepted. As
addressed in the supporting
statement, the application process is
a key trigger for updating the
required content of the program
agreement and is a direct means for
capturing the applicable
documentation for that update and
ensuring that the documentation
provided by PACE organizations,
which includes policies and
procedures, satisfies regulatory
requirements. CMS notes that past
updates to the application were
made to facilitate this process which
includes, in part, requiring similar
documentation to be provided by
both initial and expansion applicants.

PACE
Application
Section

N/A

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change
N

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Comment

CMS Response to Comment

6. Comment from UnityPoint Health:
Recommended that PACE center relocations not be subject to
providing all documents associated with the application
process.

PACE organizations that relocate an
existing PACE center site do not need
to submit an application; there is
separate replacement center
guidance that includes steps to take
for relocations. That said, the
replacement (i.e., relocation) of a
PACE center is another key trigger for
updating the required content of the
program agreement and is a direct
means for capturing the applicable
documentation for that update and
ensuring that the documentation
provided by PACE organizations,
which includes policies and
procedures, satisfies regulatory
requirements.

N/A

N

7. Comment from PACE Southeast Michigan:
Recommended that the application period be expanded to at
least six times per year rather than limiting it to the current
four dates per year.

Recommendation not accepted.
Unlike the Medicare Advantage
program, which has one opportunity
per year to submit applications, PACE
applicants have four opportunities.
CMS believes this is more than
adequate and plans to continue
offering four quarterly application
submission opportunities per year.

N/A

N

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

5

Comment

CMS Response to Comment

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

8. Comment from PACE Southeast Michigan:
Requested that CMS reduce the review time for center
openings after State Readiness Review from 60
days to 30 days. Since there is no onsite visit by CMS to the
centers, we feel that 30 days to review the approved
Readiness Review is sufficient time.

This is outside the scope of
the information collection.
That said, it is not clear what
the commenter refers to in
terms of a 30 and 60-day time
period. However, we note
the SRR is only part of the RAI
response and, per regulation,
CMS has 45 or 90 days to
review the response to the
RAI (depending on type of
application, which includes a
SRR as applicable) before
approving an application.

N/A

N

9. Comment from National PACE Association:
Page 17, Section E, in the 3rd sentence of the Note, reference

Comment accepted; edit
made to application.

Section 3.4.1 (Upload
Document E)

N

to “subordinated debt” should be “subordinated/guaranteed
debt,” as follows: “If subordinated/guaranteed debit is
identified by the PACE organization (legal entity), it should be
included in the total PACE liabilities and the amount of
subordinated/guaranteed debt must be clearly identified on
the balance sheet of the financial statements and financial
projections (if applicable).“

6

Comment

10. Comment from National PACE Association:
Page 20 – Should language in 4. related to principal
languages of the community mirror the language in the
attestation related to Explanation of Rights on p. 21? More
specifically, “Applicant agrees to make marketing materials
available to prospective and current participants in English
and in any other principal languages of the community as
determined by the State in which the PACE organization is
located (in the absence of a State standard, a principal
language of the community is any language that is spoken by
at least 5 percent of the individuals in the PACE organization’s
service area), and in Braille, if necessary.”
11. Comment from National PACE Association:
Page 27 – In the 10th bullet under 4., replace “they” with “the
potential participant.”
12. Comment from National PACE Association:
Page 27 – in the 3rd bullet under 5., replace “the written
notification” with “the reason for the denial.” This would be
consistent with 42 CFR §460.152(b)(3).
13. Comment from National PACE Association:
Page 30 – in the 1st bullet under 3., reword as follows
consistent with change due to June 3, 2019 final rule:
“Participant, after a 30-day grace period, fails to pay or make
satisfactory arrangements to pay, any premium due the PACE
”

CMS Response to Comment

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

Comment accepted; edits
made to application. In
addition to the proposed
language, we added at the end
of the attestation statement the
following “per 42 CFR
§460.82(c) and referenced
§460.82 as part of the
“Purpose” statement in the
Explanation of Rights section
(3.6). We also added
language to Section 3.6 to
align with the language in
Section 3.5.
Comment accepted; edit made
to application.

Section 3.5 (Attestation
#4)

Section 3.9 (Attestation
#4)

N

Comment accepted; edit made
to application.

Section 3.9 (Attestation
#5)

N

Comment accepted per
comment and to align with the
new PACE rule; edit made to
application.

Section 3.10
(Attestation #1)

N

N

Section 3.6 (Purpose
statement and
Attestation #4)

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Comment

CMS Response to Comment

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

14. Comment from National PACE Association:
Page 30 – in the 3rd bullet under 3., reword as follows:
“Participant is determined to no longer meet the State
Medicaid nursing facility level of care requirements and is not
deemed eligible.”

This language was already
included in the application.
No change necessary.

Section 3.10
(Attestation #3)

N

15. Comment from National PACE Association:
Page 30 – under 3. need to include language that speaks to
new reasons for involuntary disenrollment as a result of June
3, 2019 final rule: (1) The participant, after a 30-day grace
period, fails to pay or make satisfactory arrangements to pay
any applicable Medicaid spend down liability or any amount
due under the post-eligibility treatment of income process, as
permitted under §§460.182 and 460.184; and (2) Participant’s
caregiver engages in disruptive or threatening behavior.

Comment accepted. Language
added

Section 3.10
(Attestation #3)

I (nominal: simply added
an additional bullet)

16. Comment from National PACE Association:
Page 30 – under 3., references to §460.164(a) and
§460.164(b) should be to §460.164(b) and §460.164(c).
17. Comment from National PACE Association:
Page 31 – in 4., reference to §460.164(c) should be to
§460.164(d).
18. Comment from National PACE Association:
Page 31 – in 5., reference to §460.164(d) should be to
§460.164(e).

Comment accepted; edit made
to application.

Section 3.10
(Attestation #3)

N

Comment accepted; edit made
to application.

Section 3.10
(Attestation #4)

N

Comment accepted; edit made
to application.

Section 3.10
(Attestation #5)

N

19. Comment from National PACE Association:
Page 31 – in 6., reference to §460.164(e) should be to
§460.164(f).

Comment accepted; edit made
to application.

Section 3.10
(Attestation #6)

N

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Comment

CMS Response to Comment

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

20. Comment from National PACE Association:
Page 31 – in 9., consistent with June 3, 2019 final rule,
replace “in a timely manner” with “within 30 days.”

Comment accepted; edit made
to application.

Section 3.10
(Attestation #9)

N

21. Comment from National PACE Association:
Page 38 – in 3., consistent with §460.98(c), reword as
follows: “Applicant agrees, at a minimum, to provide the
following services at each PACE center as specified in 42 CFR
§460.98(c):” Also, “physician” in the 1st bullet should be
replaced with “primary care provider” to reflect the change in
the June 3, 2019 final rule.

Comment accepted; added the
words “at each PACE center.”
Also modified the bulleted
statement as follows:

Section 3.15
(Attestation #3)

N (negligible change)

22. Comment from National PACE Association:
Page 43 – in 1., the language in this attestation should
reference initial participant assessments.

Comment accepted; edit made
to application.

Section 3.18
(Attestation #1)

N

“Primary care, including
services furnished by a
primary care provider as
defined in §460.102(c) and
nursing services;”

9

Comment

23. Comment from National PACE Association:
Page 43 – in 2., June 3, 2019 final rule modified requirement
for initial comprehensive assessment to require it be
completed in a timely manner in order to allow for
development of the initial plan of care within 30 days of the
date of enrollment. Attestation should be revised to reflect
this.

CMS Response to Comment

Comment accepted; edits
made to application.
Attestation modified as
follows:

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

Section 3.18
(Attestation #2)

N

“Applicant ensures that each
participant receives an initial
face-to-face assessment
conducted by the following
IDT members and completes
the assessment in a timely
manner in order to meet the
requirements in 460.104(b):”
Also made minor word
changes in last bullet to align
with updated rule.

24. Comment from National PACE Association:
Page 44 – in 4., reference to “healthcare professionals”
should be “other team members” consistent with the PACE
rule.

Comment accepted; edit made
to application.

Section 3.18
(Attestation #4)

N

25. Comment from National PACE Association:
Page 44 – in 6., should reference to “participants/caregivers”
be “participants/designated representatives”?

Comment accepted; edit made
to application.

Section 3.18
(Attestation #6)

N

10

Comment

26. Comment from National PACE Association:
Page 44 – in 7., because unscheduled reassessments refer to
both reassessments in response to changes in health status
and in response to participants/designated representatives’
request for service, it is not accurate to say that
“unscheduled reassessments are conducted face-to-face by
the applicable IDT members specified in 42 CFR §460.104(c).”
For requests for service, “the appropriate members of the
interdisciplinary team, as identified by the interdisciplinary
team, must conduct a reassessment.” Further, it is not
necessarily the case that unscheduled reassessments related
to service requests will be conducted face-to-face under the
revised 42 CFR §460.104(d)(2).

CMS Response to Comment

Comments accepted; edits
made to application as follows
to align with updated PACE
rule (Attestation #7):

PACE
Application
Section

Section 3.18
(Attestations #7 and
#8)

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change
N

“Applicant ensures that semiannual reassessments are
conducted face-to-face by the
applicable IDT members
specified in 42 CFR
§460.104(c).”
In addition, we clarify the
applicability of
§460.104(d)(1) by modifying
the language as follows
(Attestation #8):
“Applicant ensures that there
are explicit procedures for
performance of unscheduled
reassessments as specified in
42 CFR §460.104(d)(1) and
§460.104(d)(2).”

11

Comment

CMS Response to Comment

27. Not based on comment, but CMS modified the language
to provide greater clarity and to align with the updated PACE
rule.

Modified language is as
follows:

28. Comment from National PACE Association:
Page 46 – in 3., should “assessment” be “assessed”?

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

Section 3.19
(Attestation #1)

N

Comment accepted; edit made
to application.

Section 3.20
(Attestation #3)

N

29. Comment from National PACE Association:
Referring to page 63, in the first paragraph under Medicare
and State Medicaid Capitation Payment, the second sentence
should clarify that the frailty adjuster applies to payments for
community-based, i.e., non-LTI, participants only.

Comment not accepted. After
consult with appropriate
subject matter experts, it was
determined that information is
adequate overall for that
purpose and contains accurate
information, so no change is
needed at this time.

Section 4.13
(Document Upload
Templates)

N

30. Comment from National PACE Association:
Referring to p. 68, 2nd to last paragraph, reference should be
to 42 CFR §460.164(f)?

Comment accepted; edit made
to application.

Section 4.20
(Document Upload
Templates)

N

“Applicant ensures the
integration of disciplinespecific assessments by the
IDT into a comprehensive
single plan of care for each
participant within 30 days of
the date of enrollment
consistent with the
requirements of 42 CFR
§460.106(a).”

12

Comment

CMS Response to Comment

PACE
Application
Section

Level of Applicant
Burden
I = Increases burden;
D – Decreases burden;
N – No Change

31. Comment from National PACE Association:
Referring to p. 70, in 4.21 Applicant Attestation, do
references to Center for Beneficiary Choices and Center for
Medicaid and State Operations need to be updated?

Comment accepted; edit made
to application.

Section 4.21
(Document Upload
Templates)

N

32. Comments from National PACE Association:
State Readiness Review (pp. 71-98):

Comments accepted; edits and
formatting corrections made to
State Readiness Review tool
part of application.

Readiness Review
Report

N

o Should the introduction to the State Readiness
Review section reference SRRs that exist in the
context of expansion applications?
o In general, the MET/NOT MET options in the
Criteria Met column often do not line up well with the
statement in the Readiness Criteria column.
o Referring to p. 87, reference to “multidisciplinary”
should be changed in “interdisciplinary.”
o Referring to p. 91, reference to “principle language”
should be “principal language.”
o Referring to p. 92, reference to “multidisciplinary
team” should be “interdisciplinary team.”

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