CMS-10631 HPMS_ Expansion PACE Application

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

HPMS_ Expansion PACE Application

Application Requirements (POs)

OMB: 0938-1326

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3/31/2020

HPMS: PACE Attestations

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PACE Attestations
Selected Contract #: Hxxxx
Application Type: SAE
Organization Type: National PACE
Plan Type: National PACE

Section: Trial Period
Trial Period
3.0 The purpose of this section is to ensure that SAE applicants have successfully completed the first trial period audit in order to
be able to proceed with the submission of a SAE application.
1. Applicant acknowledges that the first trial period audit has been successfully completed.
(In accordance with Chapter 17 of the PACE manual, if the response is "No," the applicant
may not proceed with the SAE application because CMS will only approve an expansion
application after an organization has completed the first trial period audit and achieved an
acceptable corrective action plan for the initial PACE center and service area.)

Yes
No

Section: Service Area
Service Area
3.1 The purpose of this section is to ensure that all PACE applicants define the proposed geographic area that will be served
consistent with the requirements of 42 CFR §460.22, §460.70, and §460.98.
1. Applicant ensures that contracted services are accessible to participants and located near
or within the geographic service area as specified in 42 CFR §460.70(b)(2).
2. Applicant agrees to operate at least one PACE center within or contiguous to the
geographic service area with capacity to allow routine attendance by participants as
specified in 42 CFR §460.98(d)(1).

Yes
No
Yes
No

B. In HPMS, on the Contract Management/Contract Service Area/Service Area Data page, enter the state and county information
for the area the Applicant proposes to serve.

C. In the Documents Section, provide a detailed map, with a scale of the complete geographic service area that includes county, zip
code, street boundaries, census tract or block or tribal jurisdiction and main traffic arteries, physical barriers such as mountains
and rivers and location of the PACE center (including the address of the PACE center facility), hospital providers, ambulatory and
institutional services sites. Depict on the map the mean travel time from the farthest points on the geographic boundaries to the
nearest ambulatory and institutional service sites.
Note: The map must be developed in accordance with 42 CFR §460.22, §460.70, and §460.98.

Section: Legal Entity and Organizational Structure
Legal Entity and Organizational Structure
3.2 The purpose of this section is to ensure that all PACE applicants are organized under State law and have a current chart
outlining the organizational structure consistent with the requirements of 42 CFR §460.60.
1. Applicant ensures that the corporate entity that signs the Program Agreement has the
legal authority to do so.

Yes

2. Applicant agrees that the Program Director is responsible for oversight and
administration of the entity (42 CFR §460.60(b)).

Yes

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No

No

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3. Applicant agrees that the Medical Director is responsible for delivery of participant care,
clinical outcomes and implementation and oversight of the quality assessment and
performance improvement (QAPI) program (42 CFR §460.60(c)).
4. Applicant agrees to maintain an up-to-date organizational chart indicating the persons
and titles of all officials in the PACE organization (42 CFR §460.60(d)).
5. Applicant agrees to indicate relationships to the corporate board, parent, affiliates, and
subsidiary corporate entities in an organizational chart.
Note: If the applicant is not part of a corporate entity, then the applicant should respond
"N/A"
6. Applicant agrees to notify CMS and SAA in writing at least 14 days before a change in
the organizational structure takes effect (42 CFR §460.60(d)(3)).
7. For any change in organizational structure that includes a Change of Ownership, the
applicant agrees to abide by the general provisions described in the MA regulations at 42
CFR 422.550.

Yes
No
Yes
No
Yes
No
N/A
Yes
No
Yes
No

8. Applicant ensures that they are organized to operate within the state consistent with all
applicable state laws.

Yes

9. If planning to do business as (d.b.a.) under a name that is different from the names of
the organization, applicant attests that it has state approval for the d.b.a.

Yes

No

No

B.In the Documents Section, upload a description of the organizational structure of the PO, including the relationship to, at a
minimum, the governing body, program director, medical director, and to any parent, affiliate or subsidiary entity.

Section: Governing Body
Governing Body
3.3 The purpose of this section is to ensure that all PACE applicants have appropriate resources and structures available to
effectively and efficiently manage administrative issues associated with PACE organization operations and participant concerns
consistent with the requirements of 42 CFR §460.62.
1. Applicant ensures operation under an identifiable governing body such as a board of
directors or a designated person functioning as such who provides oversight and authority
for the following functions:
Governance and operation;
Development of policies consistent with its mission;
Management and provision of all services, including the management of
subcontractors;
Personnel policies (that address adequate notice of termination by employees or
contractors with direct participant care responsibilities);
Fiscal operations;
Development of policies on participant health and safety; and
QAPI program.

Yes
No

(see 42 CFR §460.62(a))
2. Applicant ensures a Participant Advisory Committee is established of which the majority
consists of participants and participant representatives who advise the governing body on
participant concerns and provide them with meeting minutes that include participant issues
(42 CFR §460.62(b)).
3. Applicant agrees to appoint a participant representative to act as a liaison between the
governing body and Participant Advisory Committee, to present participant issues to the
governing body and to ensure community representation (42 CFR §460.62(c)).

Yes
No
Yes
No

B. In the Documents Section, upload a current list of the governing body members and their titles and indicate which members are
PACE participant representative(s). Include the name and phone number of a contact for the governing body and the name and
phone number of the PACE Program Director responsible for oversight and administration as described in 42 CFR §460.60(b).

Section: Fiscal Soundness
Fiscal Soundness

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3.4 The purpose of this section is to ensure that all PACE applicants meet the financial requirements consistent with 42 CFR
§460.80, §460.204, and §460.208. CMS reserves the right to request additional financial information such as the most recent
audited annual financial statements, most recent unaudited financial statements, and financial projections as it sees fit to
determine if the applicant is maintaining a fiscally sound operation.
1. Applicant maintains a fiscally sound operation as specified in 42 CFR §460.80(a)(1-3):
Total assets greater than total unsubordinated liabilities;
Sufficient cash flow and adequate liquidity to meet obligations as they become due;
and
A net operating surplus or a financial plan for maintaining solvency that is
satisfactory to CMS and the State administering agency (SAA).

Yes
No

Note: The documents requested below are not required uploads for the service area expansion application, but may be requested
as part of the Request for Additional Information (RAI) process if CMS is unable to verify that the applicant is maintaining a fiscally
sound operation.

B. In the Documents Section, upload the most recent independently audited financial statements. Audits provided in the
Documents section of the application, must include:
Opinion of a certified public accountant;
Statement of revenues and expenses;
Balance sheet;
Statement of cash flows;
Explanatory notes; and
Statements of changes in net worth.

C. In the Documents Section, upload the most recent year-to-date unaudited financial statements of the PACE legal entity.

D. In the Documents Section, upload financial projections. Note: Provide financial projections through one year beyond break-even.
(Financial projections should be prepared using the accrual method of accounting in conformity with generally accepted accounting
principles (GAAP). Prepare projections using the pro-forma financial statement methodology. For a line of business, assumptions
need only be submitted to support the projections of the line.) Projections must include:
Opening and annual balance sheet
Quarterly statements of revenues and expenses for legal entity
Projections in gross dollars which include year-end totals. (In cases where the plan is a line of business, the applicant
should also complete a statement of revenue and expenses for the line of business).
Statement and justification of assumptions
State major assumptions in sufficient detail to allow an independent financial analyst to reconstruct projected figures using
only the stated assumptions;
Include operating and capital budget breakdowns;
Address all periods for which projections are made and include inflation assumptions;
Justify assumptions to the extent that an independent financial analyst would be convinced that they are reasonable; and
Base justification on such factors as the applicant's experience and the experience of other POs.

Section: Marketing
Marketing
3.5 The purpose of this section is to ensure that all PACE applicants develop a plan for marketing and marketing materials
consistent with the requirements of 42 CFR §460.82 and PACE Manual Chapter 3 Marketing Guidelines.
1. Applicant agrees to follow PACE Manual Chapter 3 Marketing Guidelines when informing
the public about its program and giving prospective participants written information on the
following:
Description or list of benefits and services;
Description of premiums or other payment responsibilities; and
Other information necessary for prospective participants to make an informed
decision about enrollment.

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Yes
No

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2. Applicant agrees that the following information on restriction in services is included in
their marketing materials:
Participant must receive all needed health care, including primary care and
specialist physician services (other than emergency services), from the PO or from
an entity authorized by the PO; and
Participants may be fully and personally liable for the costs of unauthorized or outof-network services.
3. Applicant agrees that the marketing material is free of inaccuracies, misleading
information, or misrepresentations.
4. Applicant agrees to make marketing materials available to prospective and current
participants in English and other languages specified by the SAA, and in Braille, if
necessary.
5. Applicant agrees to submit marketing material to the HPMS module and obtain CMS
Regional Office approval of all marketing information before distribution.

Yes
No

Yes
No
Yes
No
Yes
No

6. Applicant agrees that its employees or agents will not use the following prohibited
marketing practices in accordance with 42 CFR 460.82(e)(1-5):
Discrimination of any kind, except that marketing may be directed to individuals
eligible for PACE by reason of their age;
Activities that could mislead or confuse potential participants or misrepresent the
PO, CMS, or the SAA;
Gifts or payment to induce enrollment;
Contracting outreach efforts to individuals or organizations whose sole responsibility
involves direct contact with the elderly to solicit enrollment; and
Unsolicited door-to-door marketing.
7. Applicant agrees to establish, implement, and maintain a marketing plan with
measurable enrollment objectives and a system for tracking effectiveness in accordance
with 42 CFR §460.82(f).
8. Applicant agrees that its employees or agents will not use any marketing practices that
are prohibited according to PACE regulation at 42 CFR §460.82.

Yes
No

Yes
No
Yes
No

NOTE:Marketing materials for both initial and SAE applications are captured separately, via the HPMS PACE marketing module.
Applicants must submit marketing materials to the HPMS marketing module for CMS/state review and approval within 5 days of the
submission of the application. (Note: Initial applicants must first hit the "Final Submit" button for the application itself, at which
point the contract will be made available in the HPMS marketing module. The action of hitting the final submit button for an
application submittal does not preclude the PO from submitting marketing materials.) After the application is submitted, CMS will
communicate the name of the CMS and state marketing reviewers to the applicant and the applicant may then submit all marketing
materials associated with its marketing plan via the HPMS marketing module. When submitting the materials, initial and SAE
applicants must include the contract number and "Initial Application" or "SAE Application" in the comments field of the marketing
submission (e.g., Hxxxx Initial Application). Note that SAE applicants need only submit new or revised marketing material to the
HPMS PACE Marketing Module for review. Initial PACE applicants may not begin marketing until they have been approved and have
received a copy of their program agreement signed by all parties; SAE applicants may not begin marketing in the expanded
geographic area, as applicable, until the SAE has been approved and the PO has received the amended program agreement,
accompanied by an approval letter from CMS.

Section: Explanation of Rights
Explanation of Rights
3.6 The purpose of this section is to ensure that all PACE applicants have a Participant Bill of Rights, and policies and procedures
consistent with the requirements of 42 CFR §460.110, §460.112, §460.116, and §460.118.
1. Applicant's policies and procedures ensure that the participant, his or her representative,
if any, understand their participant rights as specified in 42 CFR §460.110 §460.112,
§460.116, and §460.118.
2. Applicant's policies and procedures ensure that staff (employed and contracted) are
educated and understand participant rights as specified in 42 CFR §460.110 §460.112,
§460.116, and §460.118.
3. Applicant agrees to explain the rights to the participant at the time of enrollment in a
manner understood by the participant as specified in 42 CFR §460.110(b), §460.112, and
§460.116(b).

Yes
No
Yes
No
Yes
No

4. Applicant agrees to meet the following requirements:
Write the participant's rights in English and in any other principal languages of the
community; and
Display the participant's rights in a prominent place in the PACE center as specified
in 42 CFR §460.116(c).

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Yes
No

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5. Applicant ensures that their procedures respond to and rectify a violation of a
participant's rights in 42 CFR §460.118.

Yes

6. Applicant agrees to explain advance directives to participants, and establish them, if the
participant so desires, as specified in 42 CFR 460.112(e)(2).

Yes

No

No

B. In the Documents Section, upload a copy of your Participant Bill of Rights.

Section: Grievances
Grievances
3.7 The purpose of this section is to ensure that all PACE applicants have a formal written process for participants, their family
members or representatives to express dissatisfaction with service delivery or the quality of care furnished consistent with the
requirements of 42 CFR §460.120.
1. Applicant agrees to have a formal written process to evaluate and resolve medical and
non-medical grievances by participants, their family members, or representatives, that
includes the following:
How a participant files a grievance;
Documentation of a grievance;
Response to and resolution to a grievance in a timely manner; and
Maintenance of confidentiality of the grievance (see 42 CFR §460.120(a)).

Yes
No

2. Applicant agrees to document all expressions of dissatisfaction with service delivery or
quality of care furnished, whether written or oral (42 CFR §460.120).

Yes

3. Applicant agrees to provide participants with written information of the grievance
process upon enrollment, and annually thereafter (42 CFR §460.120(b)).

Yes

4. Applicant agrees to furnish all required services to participants during the grievance
process (42 CFR §460.120(d)).

Yes

5. Applicant agrees to discuss the specific steps that will be taken to resolve the grievance,
including timeframes for a response (42 CFR §460.120(e)).

Yes

6. Applicant agrees to maintain, aggregate and analyze information on grievance
proceedings, and use this information in the internal QAPI program (42 CFR §460.120(f)).

Yes

No

No

No

No

No

B. In the Documents Section, upload a copy of your policies and procedures for grievances. Note the policies and procedures
should specify whether the timeframes for responding to grievances are calendar days or business days.

Section: Appeals
Appeals
3.8 The purpose of this section is to ensure that all PACE applicants have a formal written appeals process consistent with the
requirements 42 CFR §460.104, §460.122, and §460.124.
1. Applicant agrees to have a formal written process, with specified timeframes for
response, to address non coverage of or nonpayment of a service, that includes the
following as specified in 42 CFR §460.122(a), and 42 CFR §460.122(c):
Written denials of coverage or payment are prepared and processed timely;
How a participant files an appeal;
Documentation of participant's appeal;
Credentialed and impartial third party, not involved in the original action and
without a stake in the outcome of the appeal, will be appointed to review the
participant's appeal;
Appeals will be responded to and resolved as expeditiously as the participant's
health condition requires, but no later than 30 calendar days after the organization
receives the appeal; and
Confidentially of a participant's appeal is maintained.
2. Applicant agrees to provide participants written information on the appeals process upon
enrollment, annually thereafter, and whenever the interdisciplinary team (IDT) denies a
request for services or payment as specified in 42 CFR §460.122(b), and 42 CFR §460.124.

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Yes
No

Yes
No

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3. Applicant agrees to appoint an appropriately credentialed impartial third party and give
all parties involved in the appeal appropriate written notification and a reasonable
opportunity to present evidence related to the dispute in person, and in writing as specified
in 42 CFR §460.122(c) and 42 CFR §460.122(d).

Yes
No

4. Applicant agrees to furnish the disputed services to Medicaid participants until issuance
of the final determination, if the following conditions are met as specified in 42 CFR
§460.122(e)(1):
The PO is proposing to terminate or reduce services currently being furnished to the
participant; and
The participant requests continuation of the service with the understanding that he
or she may be liable for the costs of the contested service if the determination is
not made in his or her favor.
5. Applicant agrees to furnish all other required services to the participant as specified in
42 CFR §460.122(e)(2).
6. Applicant agrees to furnish the disputed service as expeditiously as the participant's
health condition requires, if a determination is made in favor of the participant on appeal as
specified in 42 CFR §460.122(g).
7. Applicant agrees to notify CMS, the SAA and the participant at the time a decision is
made that is wholly or partially adverse to the participant as specified in 42 CFR
§460.122(h).
8. Applicant agrees to maintain, aggregate and analyze information on appeal proceedings,
and use this information in the internal QAPI program as specified in 42 CFR §460.122(i).
9. Applicant agrees to have an expedited appeals process for situations in which the
participant believes that his or her life, health, or ability to regain maximum function could
be seriously jeopardized, absent provision of the service in dispute as specified in 42 CFR
§460.122(f).
10. Applicant agrees to respond to an expedited appeal as expeditiously as the participant's
health condition requires, but no later than 72 hours after the organization receives the
appeal as specified in 42 CFR §460.104(d)(2)(ii), and 42 CFR §460.122(f)(2).
11. Applicant agrees to make its participants aware that the applicant can extend the 72hour timeframe for an expedited appeal by up to 14 calendar days for either of the
following reasons as specified in 42 CFR §460.104(d)(2)(iii) and 42 CFR §460.122(f)(3):
The participant requests the extension; and
The organization justifies to the SAA the need for additional information and how
the delay is in the interest of the participant.

Yes
No

Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No

Yes
No

12. Applicant agrees to do the following as specified in 42 CFR §460.124:
Inform a participant in writing of his or her additional appeal rights under Medicare
or Medicaid managed care, or both; and
Assist the participant in choosing which external appeal avenue to pursue, and
forward the appeal to the appropriate external entity.

Yes
No

B. In the Documents Section, upload your policies and procedures for the appeals process.
Note: This process must be developed in accordance with 42 CFR §460.122.

C. In the Documents Section, upload your policies and procedures for informing participants of their additional appeals rights under
Medicare and/or Medicaid, including the process for filing further appeals.
Note: Policies and procedures must be developed in accordance with 42 CFR §460.124.

Section: Enrollment
Enrollment
3.9 The purpose of this section is to ensure that all PACE applicants enroll participants into the PACE program consistent with the
requirements at 42 CFR §460.150, §460.152, §460.154, §460.156, §460.158, and §460.160.

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1. Applicant agrees to enroll individuals who meet all of the following eligibility
requirements as specified in 42 CFR §460.150(b), and 42 CFR §460.150(c):
Is 55 years of age or older;
Is determined by the SAA to need the nursing facility services level of care for
coverage under the State Medicaid plan;
Resides in the PO service area;
Meets any additional program specific eligibility conditions imposed under the PACE
program agreement; and
Able to live in a community setting without jeopardizing his or her health or safety
as determined by criteria specified in the program agreement.
PACE enrollee may be, but is not required to be, any or all of the following: (1)
entitled to Part A, (2) enrolled under Part B, (3) Eligible for Medicaid, (4) private
pay.

Yes
No

2. Applicant agrees to comply with the requirements of 42 CFR §460.150(d) and not
restrict enrollment based on Medicare or Medicaid eligibility.

Yes

3. Applicant agrees that the enrollment agreement minimally includes the requirements as
specified in 42 CFR §460.154.

Yes

No

No

4. 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 42
CFR §460.152(a):
Exhibits and explains each element of the enrollment agreement;
Informs participant that PACE is the sole service provider;
Informs participant that PACE guarantees access to all necessary services, but not
access to specific providers;
Provides a list of employed and 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 for PACE 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 they can be cared for
appropriately in a community setting and that the individual meets all PACE
eligibility criteria.

Yes
No

Note: Intake is an intensive process during which PACE staff members make one or more
visits to a potential participant's residence and the potential participant makes one or more
visits to the PACE center.
5. Applicant agrees to do the following when enrollment is denied to a prospective
participant because his/her health or safety would be jeopardized by living in the
community as specified in 42 CFR §460.152(b):
Notify the individual in writing of the reason for the denial;
Refer the individual to alternative services, as appropriate;
Maintain supporting documentation of the written notification; and
Notify CMS and SAA and make documentation available for review.

Yes
No

6. Applicant agrees to give the enrolled participant the following items as specified in 42
CFR §460.156(a):
A copy of the enrollment agreement;
A PACE membership card;
Emergency information to be posted in the participant's residence explaining PACE
membership and how to access emergency services; and
PACE program stickers for Medicare and Medicaid cards that include the PACE
phone number.
7. Applicant agrees to submit participant information to CMS and SAA in accordance with
established procedures as specified in 42 CFR §460.156(b).

Yes
No

Yes
No

8. Applicant agrees to meet the following requirements when making necessary changes in
the enrollment agreement as specified in 42 CFR §460.156(c):
Give an updated copy to the participant; and
Explain the changes to the participant, caregiver, or representative in a way they
understand.
9. Applicant ensures that the effective date for participant enrollment in the PACE program
is the first day of the calendar month following the date the PO receives the signed
enrollment agreement as specified in 42 CFR §460.158.

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Yes
No

Yes
No

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10. Applicant agrees to continue enrollment until the participant's death, regardless of
changes in health status, unless either of the following actions occur as specified in 42 CFR
§460.160(a):
The participant voluntarily disenrolls; or
The participant is involuntarily disenrolled in accordance with PACE regulations.
11. Applicant agrees to cooperate with the annual SAA reevaluation of the participant's
continued need for nursing facility level of care as required under the State Medicaid plan.
If the SAA permanently waives the requirement due to SAA determination that there is no
reasonable expectation of improvement or significant change in the participant's condition,
applicant agrees to maintain documentation of SAA waiver and justification in the
participant's medical record as specified in 42 CFR §460.160(b)(1).
12. Applicant agrees to continue enrollment for the participant who no longer meets the
State Medicaid nursing facility level of care, if the SAA deems the participant eligible to
continue until the next annual revaluation because the participant reasonably would be
expected to meet the nursing facility level of care requirement within the next 6 months
without continued participation in the PACE program as specified in 42 CFR §460.160(b)(2).

Yes
No

Yes
No

Yes
No

13. Applicant agrees to work in consultation with the SAA in making a determination of
deemed continued eligibility as specified in 42 CFR §460.160(b)(3):
Use the SAA established criteria for "deemed continued eligibility" which is
determined through applying the criteria to a review of the medical record and plan
of care and is specified in the program agreement.

Yes
No

B. In the Documents Section, upload policies and procedures for eligibility and enrollment, including the State's criteria used to
determine if individuals are able to live in a community setting without jeopardizing their health or safety.

C. In the Documents Section, upload any additional enrollment criteria.
Note: The policies and procedures for eligibility and enrollment must be developed in accordance with 42 CFR §460.150, §460.152,
§460.154, §460.156, §460.158, and §460.160.

Note: Applicants are to submit a copy of the enrollment agreement, consistent with the requirements stipulated in §460.154, to
the HPMS PACE marketing module for review and approval.

Section: Disenrollment
Disenrollment
3.10 The purpose of this section is to ensure that all PACE applicants voluntarily or involuntarily disenroll participants and reinstate
them in other Medicare and Medicaid Programs, or the PACE program consistent with the requirements of 42 CFR §460.162
§460.164, §460.166, §460.168, §460.170, and §460.172.
1. Applicant agrees to meet the following requirements regarding documentation for
disenrollment as specified in 42 CFR §460.172:
Have a policy and procedure in place to document the reasons for all voluntary and
involuntary disenrollments;
Make documentation available for review by CMS and the SAA; and
Use the internal QAPI program to review documentation on voluntary
disenrollment.
2. Applicant agrees to execute disenrollment for any participant initiating voluntary
disenrollment from the program without cause at any time as specified in 42 CFR §460.162.

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Yes
No

Yes
No

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3. Applicant agrees that involuntary disenrollment of a participant will only be initiated for
any of the following reasons as specified in 42 CFR §460.164(a), and 42 CFR §460.164(b):
Participant fails to pay, or to make satisfactory arrangements to pay, any premium
due the PO after a 30-day grace period;
Participant moves out of the PACE program service area or is out of the service area
for more than 30 consecutive days, unless the PO agrees to a longer absence due
to extenuating circumstances;
Participant is determined to no longer meet the State Medicaid nursing facility level
of care requirements and is no longer deemed eligible;
PACE program agreement with CMS and the SAA is not renewed or is terminated;
PO is unable to offer health care services due to the loss of State licenses or
contracts with outside providers;
Participant engages in disruptive or threatening behavior by exhibiting behavior
that jeopardizes his or her health or safety, or the safety of others; and
Participant with decision-making capacity refuses to comply with the care plan or
terms of the enrollment agreement.
4. Applicant agrees to have a policy and procedure that includes documentation
requirements for disenrollment of a participant with disruptive or threatening behavior as
specified in 42 CFR §460.164(c) that includes:
Reason for the proposed involuntary disenrollment; and
Efforts to remedy the situation.
5. Applicant agrees not to involuntarily disenroll a participant who engages in noncompliant behavior if the behavior (including repeated non-compliance with medical advice
and repeated failure to keep appointments) is related to a mental or physical condition
unless the behavior jeopardizes his or her health or safety, or the safety of others as
specified in 42 CFR §460.164(d).
6. Applicant agrees to ensure that before an involuntary disenrollment is effective, the SAA
reviewed and determined that the applicant has adequately documented acceptable
grounds for disenrollment as specified in 42 CFR §460.164(e).

Yes
No

Yes
No

Yes
No
Yes
No

7. Applicant agrees to take the following actions in executing the disenrollment as specified
in 42 CFR §460.166(a), and 42 CFR §460.166(b)(2):
Use the most expedient process allowed under Medicare and Medicaid procedures
and set forth in the PACE program agreement;
Coordinate the disenrollment date between Medicare and Medicaid (for dual eligible
participants);
Give reasonable advance notice to the participant; and
Continue to deliver PACE services to the participant until the date enrollment is
terminated.
8. Applicant agrees to establish a disenrollment policy and procedure to ensure that the
participant is aware they must continue to use PACE services and remain liable for PACE
premiums until the disenrollment is effective as specified in 42 CFR §460.166(b)(1).

Yes
No

Yes
No

9. Applicant agrees to take the following actions to facilitate a participant's reinstatement in
other Medicare and Medicaid programs after disenrollment as specified in 42 CFR §460.168:
Make appropriate referrals and transmit copies of medical records to new providers
in a timely manner; and
Work with CMS and SAA to reinstate the participant in other Medicare and Medicaid
programs for which the participant is eligible.
10. Applicant agrees to permit a previously disenrolled participant to be reinstated in the
PACE program as specified in 42 CFR §460.170(a).
11. Applicant agrees to reinstate a previously disenrolled participant with no break in
coverage if the reason for disenrollment is failure to pay the premium, and the participant
pays the premium before the effective date of disenrollment as specified in 42 CFR
§460.170(b).

Yes
No

Yes
No
Yes
No

B. In the Documents Section, upload a copy of the Voluntary Disenrollment policies and procedures.

C. In the Documents Section, upload a copy of the Involuntary Disenrollment policies and procedures.

Section: Personnel Compliance
Personnel Compliance
3.11 The purpose of this section is to ensure that all PACE applicants have a written plan for personnel training and competency
compliance that is consistent with the requirements of 42 CFR §460.64, §460.66, §460.68, and §460.71.

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1. Applicant ensures that staff having direct participant contact, (employed and contracted)
meet the following conditions as specified in 42 CFR §460.64:
Are legally authorized (e.g., currently licensed, registered, or certified if applicable)
to practice in the state in which they perform the function or action as evidenced by
primary verification of licenses or certifications;
Act within the scope of their authority to practice;
Have one year of experience with a frail or elderly population;
Meet a standardized set of competencies for the specific position description
established by the applicant and approved by CMS prior to working independently;
and
Be medically cleared for communicable diseases and have all immunizations up-todate prior to engaging in direct participant contact.

Yes
No

Note: In addition to the qualifications specified above, applicant ensures that physicians
meet the qualifications and conditions in §410.20.
2. Applicant agrees to provide training to maintain and improve the skills and knowledge of
each staff member with respect to the individuals specific duties that results in his or her
continued ability to demonstrate the skills necessary for the performance of the position as
specified in 42 CFR §460.66(a).
3. Applicant agrees to develop a training program as specified in 42 CFR §460.66(b) for
each personal care attendant to establish the individual's competency on furnishing
personal care services and specialized skills associated with specific care needs of individual
participants.
Personal care attendants must exhibit competency before performing personal care services
independently as specified in 42 CFR §460.66(c).
4. Applicant agrees to provide each staff (employed and contracted) with an orientation
that includes the organization's mission, philosophy, policies on participant rights,
emergency plan, ethics, the PACE benefit, and any policies related to the job duties of
specific staff prior to working independently as specified in 42 CFR §460.71(a)(1).
5. Applicant agrees to develop a competency evaluation program that identifies those skills,
knowledge, and abilities that must be demonstrated by direct participant care staff
(employees and contractors) as specified in 42 CFR §460.71(a)(2). Applicant also agrees
that the competency program must be evidenced as completed before performing
participant care and on an ongoing basis by qualified professionals as specified in 42 CFR
§460.71(a)(3).
6. Applicant agrees to designate a staff member to oversee the orientation and competency
evaluation programs for employees and work with the PACE contractor liaison to ensure
compliance by contracted staff as specified in 42 CFR §460.71(a)(4).

Yes
No

Yes
No

Yes
No

Yes
No

Yes
No

7. Applicant ensures that all staff (employed and contracted) furnishing direct participant
care services meet the following requirements as specified in 42 CFR §460.71(b):
Comply with State or Federal requirements for direct patient care staff in their
respective settings;
Comply with Requirements of 42 CFR §460.68(a), regarding persons with criminal
convictions;
Have verified current certifications or licenses for their respective positions;
Are free of communicable diseases and are up to date with immunizations before
performing direct patient care;
Have been oriented to the PACE program; and
Agree to abide by the philosophy, practices, and protocols of the PO.

Yes
No

Section: Program Integrity
Program Integrity
3.12 The purpose of this section is to ensure that all PACE applicants employ individuals or contract with organizations consistent
with the requirements of 42 CFR §460.68.
1. Applicant agrees to comply with requirements of 42 CFR §460.68(a) and attests that it
will not employ or contract with individuals who have been excluded from participation in
the Medicare or Medicaid programs, who have been convicted of criminal offenses related to
their involvement in health or social service programs, or in any capacity where an
individuals' contact with participants would pose a potential risk because the individual has
been convicted of physical, sexual, drug or alcohol abuse.
2. Applicant agrees to comply with requirements of 42 CFR §460.68(b) regarding
identification of members of its governing body or any immediate family member having a
direct or indirect interest in contracts, and attests that it will have disclosure and recusal
policies and procedures to ensure compliance with 42 CFR §460.68(b) and (c).

Yes
No

Yes
No

Section: Contracted Services

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Contracted Services

3.13 The purpose of this section is to ensure that all PACE applicants execute contracts consistent with the requirements of 42 CFR
§460.70, §460.71, §460.80, §460.98, and §460.100.
1. Applicant agrees that the organization will have a written contract with each outside
organization, agency, or individual that delivers administrative or care-related services not
furnished directly by the PO except for emergency services as specified in 42 CFR
§460.70(a), and 42 CFR §460.100.

Yes
No

2. Applicant agrees that the organization will only execute a contract with contractors that
meet all applicable Federal and State requirements including, but not limited, to the
following as specified in 42 CFR §460.70(b)(1), §460.70(b)(2), §460.98, and §460.100:
An institutional contractor such as a hospital or skilled nursing facility must meet
Medicare or Medicaid participation requirements;
A practitioner or supplier must meet Medicare or Medicaid requirements applicable
to the services delivered;
Contractors must comply with the PACE requirements for service delivery,
participant rights, and participation in QAPI activities; and
Contractors must be accessible to participants and located either within or near the
PO's service area.

Yes
No

3. Applicant agrees that the organization designates an official liaison to coordinate
activities between contractors and the organization as specified in 42 CFR §460.70(b)(3).

Yes

4. Applicant agrees to maintain a current list of all contractors on file at the PACE center
and distribute the list to anyone upon request as specified in 42 CFR §460.70(c).

Yes

5. Applicant agrees to develop an oversight process that the PO will use to ensure that
contracts and contractors meet PACE program and Federal requirements, inclusive of being
HIPAA compliant.
6. Applicant agrees that each contract contains the requirements as specified in 42 CFR
§460.70(d).
7. Applicant acknowledges it cannot contract with another entity to furnish PACE Center
Services unless it is fiscally sound as defined in 42 CFR §460.80(a), and has demonstrated
competence with the PACE model as evidenced by successful monitoring by CMS and the
SAA.

No

No
Yes
No
Yes
No
Yes
No

Section: Required Services
Required Services
3.14 The purpose of this section is to ensure that all PACE applicants provide a benefit package for PACE participants consistent
with the requirements of 42 CFR §460.92, and 42 CFR §460.96.
1. Applicant agrees to provide a PACE benefit package for all participants, regardless of the
source of payment as specified in 42 CFR §460.92, that includes the following:
All Medicare-covered items and services;
All Medicaid-covered items and services as specified in the State's approved
Medicaid plan; and
Other services that the IDT determines are necessary to improve and maintain the
participant's overall health status.

Yes
No

2. Applicant agrees to provide a PACE benefit package for all participants, regardless of the
source of payment as specified in 42 CFR §460.96, that excludes the following:
Services not authorized by the IDT, even if a required service, unless it is an
emergency service;
Inpatient private room and/or private duty nursing (unless medically necessary)
and non-medical items for personal convenience (unless authorized by IDT);
Cosmetic surgery, which does not include surgery that is required for improved
functioning of a malformed part of the body resulting from an accidental injury or
for reconstruction following mastectomy;
Experimental medical, surgical, or other health procedures; and
Services delivered outside the United States (except for those services furnished in
accordance with regulatory requirements and as permitted under the State's
approved Medicaid Plan).

Yes
No

Section: Service Delivery
Service Delivery

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3.15 The purpose of this section is to ensure that all PACE applicants have a written plan to furnish care that meets the needs of
each participant consistent with the requirements of 42 CFR §460.98, and §460.102.
1. Applicant agrees to establish and implement a written plan to furnish care that meets
the needs of each participant in all care settings 24 hours a day, every day of the year as
specified in 42 CFR §460.98(a).

Yes
No

2. Applicant agrees to provide services as specified in 42 CFR §460.98(b):
Including comprehensive medical, health, and social services that integrate acute
and long-term care; and
Are delivered in the PACE center, the participant residence, and inpatient facilities
to all participants without discrimination based on race, ethnicity, national origin,
religion, sex, age, sexual orientation, mental or physical disability, or source of
payment.

Yes
No

3. Applicant agrees, at a minimum, to provide the following services as specified in 42 CFR
§460.98(c):
Primary care including physician and nursing services;
Social services;
Restorative therapies including physical therapy and occupational therapy;
Personal care and supportive services;
Nutritional counseling;
Recreational therapy;
Meals; and
Care management by an interdisciplinary care team.

Yes
No

4. Applicant agrees to operate at least one PACE center in or contiguous to its defined
service area that meet the following conditions as specified in 42 CFR §460.98(d) and 42
CFR §460.98(e):
Have sufficient capacity to allow routine attendance by participants;
Is accessible and has adequate services to meet the needs of its participants;
Offers the full range of services with sufficient staff to meet the needs of
participants at each center if the PO operates more than one center; and
Have participants attend the center as frequently as the IDT determines is
necessary based upon the preferences and needs of each participant.
5. Applicant agrees to provide each participant primary medical care delivered by a PACE
primary care physician as specified in 42 CFR §460.102(c)(1), and 42 CFR §460.102(c)(2)
who does the following:
Manages the participant's medical situations; and
Oversees the participant's use and provision of care by medical specialists and
inpatient facilities.

Yes
No

Yes
No

Section: Infection Control
Infection Control
3.16 The purpose of this section is to ensure that all PACE applicants follow accepted policies and standard procedures with respect
to infection control, including at least the standard precautions developed by the Centers for Disease Control and Prevention and
PACE applicants have a written plan for infection control that is consistent with the requirements of 42 CFR §460.74.
1. PACE applicants have a written plan for infection control that is consistent with the
requirements of 42 CFR §460.74.
2. Applicant agrees to follow, at a minimum, standard precautions developed by the
Centers for Disease Control and Prevention.
Note: Refer to the following link: http://www.cdc.gov
3. Applicant agrees to establish, implement and maintain an Infection Control Plan that
meets the following requirements:
(1)Ensures a safe and sanitary environment.
(2) Prevents and controls the transmission of disease and infection.
4. Applicant assures that its infection control plan includes, but is not limited to, the
following:
(1) Procedures to identify, investigate, control, and prevent infections in every PACE center
and in each participant's place of residence.
(2) Procedures to record any incidents of infection.
(3) Procedures to analyze the incidents of infection to identify trends and develop corrective
actions related to the reduction of future incidents.

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Yes
No
Yes
No
Yes
No

Yes
No

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Section: Interdisciplinary Team
Interdisciplinary Team

3.17 The purpose of this section is to ensure that all PACE applicants have qualified staff available to support IDT composition and
operations consistent with the requirements of 42 CFR §460.102.
1. Applicant ensures that each participant, in order to meet their individual needs, is
assigned to and comprehensively assessed by an IDT at the attended PACE center as
specified in 42 CFR §460.102(a).
2. Applicant ensures that the IDT is composed of at least a Primary care physician,
Registered nurse, Master's-level social worker, Physical therapist, Occupational therapist,
Recreational therapist or activity coordinator, Dietitian, PACE center manager, Home care
coordinator, Personal care attendant or representative, Driver or representative as specified
in 42 CFR §460.102(b).
3. Applicant ensures that primary medical care is provided by a PACE primary care
physician who is responsible for the following as specified in 42 CFR §460.102(c):
Managing participant medical situations; and
Overseeing the participant use of medical specialists and inpatient care.

Yes
No
Yes
No

Yes
No

4. Applicant ensures that the IDT does the following as specified in 42 CFR §460.102(d):
Completes initial assessments, periodic reassessments, and plans of care;
Coordinates twenty-four hour care delivery;
Communicates regularly about, and remains alert to, the medical, functional, and
psychosocial condition of each participant;
Documents changes of participant's condition in the medical record consistent with
documentation policies established by the medical director; and
Serves primarily PACE participants.
5. Applicant ensures internal procedures governing the exchange of information between
team members, contractors, and participants and their caregivers consistent with the
requirements for confidentiality in 42 CFR §460.200(e).

Yes
No

Yes
No

Section: Participant Assessment
Participant Assessment
3.18 The purpose of this section is to ensure that all PACE applicants complete initial comprehensive participant assessments,
reassessments, and unscheduled reassessments consistent with requirements of 42 CFR §460.104.
1. Applicant ensures that participant assessments are comprehensive, in person, and
include, at a minimum (42 CFR §460.104(a)(4)):
Physical and cognitive function and ability;
Medication use (prescription, over the counter and alternative medications);
Participant and caregiver preferences for care;
Socialization and availability of family support;
Current health status and treatment needs;
Nutritional status;
Home environment including home access and egress;
Participant behavior;
Psychosocial status;
Medical and dental status; and
Participant language.

Yes
No

2. Applicant ensures that each participant receives an initial face-to-face assessment
conducted by the following IDT members promptly after enrollment (sometimes these
assessments can be done prior to the actual enrollment date):
Primary care physician;
Registered nurse;
Master's level social worker;
Physical therapist;
Occupational therapist;
Recreation therapist or activity coordinator;
Dietitian;
Home care coordinator; and
Other healthcare professionals as determined by the IDT. (See 42 CFR §460.104(a)
(1), §460.104(a)(2) and §460.104(a)(3).)

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No

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3. Applicant ensures that IDT members conducting the initial assessments promptly
consolidate their findings into a single plan of care addressing: problem, intervention,
measurable outcomes, staff responsible, outcome met/not met having measurable goals
and documented in the participant medical record (42 CFR §460.104(b)).

Yes
No

4. Applicant ensures that each participant receives a face-to-face reassessment conducted
semiannually by the following IDT members or more often if the participant's condition
dictates (42 CFR §460.104(c)(1)):
Primary care physician;
Registered nurse;
Master's level social worker;
Recreational therapist or activity coordinator; and
Other healthcare professionals as determined by the IDT.

Yes
No

5. Applicant ensures that each participant receives a face-to-face reassessment conducted
annually by the following IDT members (42 CFR §460.104(c)(2)):
Physical therapist;
Occupational therapist;
Dietitian;
Home care coordinator; and
Other healthcare professionals as determined by the IDT.

Yes
No

6. Applicant ensures that IDT members conducting reassessments promptly complete the
following:
Reevaluate the care plan and discuss changes with the IDT and
participant/caregiver;
Revise the plan of care and update measurable goals based on IDT and participant
approval;
Deliver services identified in the revised care plan; and
Document assessments and any revisions to the plan of care in the participant
medical record.
7. Applicant ensures that the IDT conducts unscheduled reassessments when there are (42
CFR §460.104(d)):
Changes in participant health or status or psychosocial status; or
Requests by participants/caregivers for reassessment.

Yes
No

Yes
No

8. Applicant ensures that unscheduled reassessments are conducted face-to-face by the
applicable IDT member.

Yes

9. Applicant ensures that there are explicit procedures for performance of unscheduled
reassessments requested by the participant/caregiver (42 CFR §460.104(d)(2)).

Yes

No

No

Section: Plan of Care
Plan of Care
3.19 The purpose of this section is to ensure that all PACE applicants develop, implement, and evaluate a plan of care for each
participant that is consistent with the requirements of 42 CFR §460.106.
1. Applicant ensures prompt integration of discipline-specific assessments by the IDT into a
comprehensive single plan of care for each participant.

Yes
No

2. Applicant ensures that the plan of care specifies: Participant medical, physical,
psychological, and social needs identified during assessment; and
Intervention;
Measurable outcomes to be achieved;
Implementation frequency intervention;
Staff responsible; and
Outcome met/not met.

Yes
No

3. Applicant ensures that the IDT members coordinate and monitor delivery of all services
(direct and contracted and in all settings) prescribed in the care plan.

Yes

4. Applicant ensures that the IDT members continuously update the care plan as
participant health status changes and communicate changes to all IDT members.

Yes

5. Applicant ensures that the IDT reevaluates the goals and measurable outcomes of each
participant's care plan at least semiannually.

Yes

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No

No

No

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6. Applicant ensures that the participant and/or caregiver participate in the development,
review, and reevaluation of the care plan.

Yes
No

7. Applicant ensures that the IDT provides documentation in the medical record for the
following:
Original plan of care;
Ongoing changes to the plan of care;
Participant/caregiver preferences and concerns; and
IDT discussion that demonstrates collaborative participation in developing and
updating the single comprehensive plan of care.

Yes
No

Section: Restraints
Restraints
3.20 The purpose of this section is to ensure that all PACE applicant's comply with the physical and chemical restraint requirements
of 42 CFR §460.114.
1. Applicant agrees to use the least restrictive and most effective restraint available.
Note: A restraint may be chemical or physical and is defined in the regulation at 42 CFR
§460.114(a).
2. Applicant agrees to restrict the use of restraints to situations that the IDT determines
necessary to ensure the participant's physical safety or the safety of others.
3. Applicant ensures that restraints are used for a defined, limited period of time based
upon the assessment needs of the participant in accordance with safe and appropriate
restraining techniques after other less restrictive measures have been found to be
ineffective to protect the participant or others from harm, and are removed or ended at the
earliest possible time.
4. Applicant ensures that the condition of the restrained participant is continually assessed,
monitored and reevaluated.

Yes
No
Yes
No
Yes
No
Yes
No

Section: Physical Environment
Physical Environment
3.21 The purpose of this section is to ensure that all PACE applicants provide a safely designed PACE center and maintain
equipment consistent with the requirements of 42 CFR §460.72.
1. Applicant ensures a PACE center which:
Is designed, constructed, equipped, and maintained to provide physical safety for
participants, personnel, and visitors; and
Provides a safe, sanitary, functional, accessible, and comfortable environment for
the delivery of services and preservation of participant dignity and privacy.

Yes
No

2. Applicant ensures that suitable space and equipment exist to provide the following:
Primary medical care and treatment;
Therapeutic recreation;
Team meetings;
Restorative therapies;
Personal care;
Socialization activities; and
Dining services.
3. Applicant ensures that all equipment is maintained according to manufacturer's
recommendations.
4. Applicant ensures the PACE center meets the occupancy provisions of the current edition
of the National Fire Protection Association's Life Safety Code that apply to the type of
setting in which the center is located.
Note: Exceptions are specified in 42 CFR §460.72(b).

Yes
No

Yes
No
Yes
No

Section: Emergency and Disaster Preparedness
Emergency and Disaster Preparedness

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3.22 The purpose of this section is to ensure that all PACE applicants have written plans for medical and nonmedical emergency
care and disaster response that are consistent with the requirements of CFR §460.84 and §460.100.
1. Applicant agrees to comply with all applicable Federal, State and local emergency
preparedness requirements. This includes establishing and maintaining an emergency
preparedness program that meets all requirements as specified in 42 CFR §460.84.
2. Applicant ensures that the emergency plan holds harmless CMS, the State, and the PACE
participant if the PO does not pay for emergency services as specified in 42 CFR
§460.100(a).
3. Applicant agrees to provide for emergency services, both inpatient and outpatient
settings, by a qualified emergency services provider, other than the PO or one of its
contract providers, either in or out of the PO's service area, in order to evaluate or stabilize
an emergency medical condition as specified in 42 CFR §460.100(b).
4. Applicant ensures that the participant and/or caregiver understand when and how to get
emergency care, and that no prior authorization is required as specified in 42 CFR
§460.100(d).
5. Applicant agrees to provide access to on-call providers 24-hours a day to consult about
emergency services as specified in 42 CFR §460.100(e)(1).
6. Applicant agrees to provide authorization of urgently needed out-of-network services and
post-stabilization care services following emergency services and provide coverage when
services are pre-approved by the PO, the PO cannot be contacted, or the PO did not
respond to a request for approval within 1 hour after being contacted as specified in 42 CFR
§460.100(e).

Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No

Section: Transportation Services
Transportation Services
3.23 The purpose of this section is to ensure that all PACE applicants provide safe and accessible transportation consistent with the
requirements of 42 CFR §460.76.
1. Applicant agrees to provide safe, properly-equipped, and accessible transportation
services to meet the needs of the participant population at 42 CFR §460.76(a).

Yes

2. Applicant agrees to maintain the transportation vehicles it owns, rents, or leases in
accordance with the manufacturer's recommendations at 42 CFR §460.76(b)(2).

Yes

3. Applicant ensures that if the transportation services are provided by a contractor, the
vehicles are maintained in accordance with the manufacturer's recommendations at 42 CFR
§460.76(b)(2).
4. Applicant ensures that all transportation vehicles are equipped with an operable handsfree device to communicate with the PACE center and notify staff when relevant changes in
a participant's health status occur at 42 CFR §460.76(c).
5. Applicant ensures that all transportation personnel (employed and contracted) receive an
initial orientation and periodic refresher training to manage participant special needs and
emergency situations at 42 CFR §460.76(d).
6. Applicant agrees, that as part of the IDT process, PO staff (employees and contractors)
must communicate information and relevant changes in a participant's care plan to
transportation personnel including, but not limited to, advance directives at 42 CFR
§460.76(e).
7. Applicant agrees that the transportation system has been modified to accommodate the
proposed service area/site expansion.

No

No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No

Section: Dietary Services
Dietary Services
3.24 The purpose of this section is to ensure that all PACE applicants provide meals that meet the participant's daily nutritional and
special dietary needs consistent with the requirements of 42 CFR §460.78.
1. Applicant ensures that meals are nourishing, palatable, well-balanced, meet
recommended daily nutritional content (RDA), and meet the participant's daily nutritional
and special dietary needs as documented in the participant's assessment and care plan at
42 CFR §460.78(a).
2. Applicant agrees to provide meals that meet the following requirements consistent with
42 CFR §460.78(a): be prepared by methods that conserve nutritive value, flavor and
appearance; be prepared in a form designed to meet individual needs; and be prepared and
served at the proper temperature.

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Yes
No
Yes
No

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3. Applicant agrees to provide substitute foods or nutritional supplements that meet the
daily nutritional and special dietary needs of any participant who refuses or cannot tolerate
the food served, or does not eat adequately (42 CFR §460.76(a)(2)).

Yes
No

4. Applicant agrees to provide nutritional support based on participant condition or
diagnosis and physician orders which include:
Tube feedings;
Total parenteral nutrition; and
Peripheral parenteral nutrition.

Yes
No

(42 CFR §460.78(a)(3))
5. Applicant agrees to procure foods (including nutritional supplements and nutrition
support items) from sources approved, or considered satisfactory by Federal, State, Tribal
or local authorities with jurisdiction over the service area of the organization. Applicant also
agrees to store, prepare, distribute and serve foods (including nutritional supplements and
nutrition support items) and dispose of food under safe and sanitary conditions.

Yes
No

Section: Termination
Termination
3.25 The purpose of this section is to ensure that all PACE applicants have a detailed written plan for phase-down in the event of
termination consistent with the requirements of 42 CFR §460.50, §460.52, and §460.210.
1. Applicant agrees that the following are notified in advance of termination as specified in
42 CFR §460.50(d):
Ninety day advance notice to CMS and the SAA; and
Sixty day advance notice to the participant.

Yes
No

2. Applicant agrees to notify the following of termination and transition procedures in
writing as specified in 42 CFR §460.52(a)(1):
CMS;
SAA;
Community; and
Participant.

Yes
No

3. Applicant ensures a process to assist participants with the following as specified in 42
CFR §460.52(a):
Obtaining reinstatement of conventional Medicare and Medicaid benefits when
terminating;
Transitioning participant care to other providers when terminating; and
Terminating marketing and enrollment activities.
4. Applicant agrees to supply new providers the participant medical records, during the
process of terminating the PACE program agreement as specified in 42 CFR §460.52(b).

Yes
No

Yes
No

B. In the Documents Section, upload your termination plan.
Note: The plan for termination must be developed in accordance with 42 CFR §460.50 and §460.52.

Section: Maintenance of Records & Reporting Data
Maintenance of Records & Reporting Data
3.26 The purpose of this section is to ensure that all PACE applicants maintain records and submit reports consistent with the
requirements of 42 CFR §460.200.
1. Applicant ensures data collection, record maintenance, and report submission as
required by CMS and the State.
Note: Reports include those necessary for CMS and the State to monitor the operation,
cost, quality, effectiveness of the program, and establish payment rates.

Yes
No

2. Applicant ensures CMS and SAA access to data and records including, but not limited to:
Participant health outcome data;
Financial books and records;
Medical records; and
Personnel records.

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Yes
No

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3. Applicant ensures policies and procedures to safeguard data, books and records against
the following:
Loss;
Destruction;
Unauthorized use; and
Inappropriate alteration.

Yes
No

4. Applicant ensures confidentiality of health information through policies and procedures
that do the following:
Safeguard privacy and confidentiality of participant health information, including
mental health information, per HIPAA and other Federal and State laws;
Maintain complete records in an accurate and timely manner; and
Provide participants timely access to review and copy their own medical records as
well as request amendments to the record.

Yes
No

5. Applicant ensures retention of records for the longest of the following periods:
Time specified in State law;
Six years from the last entry date in the record or for medical records of disenrolled
participants, 6 years after the date of disenrollment; or
Completion of litigation or associated resolution of claims, financial management
review or audit findings.

Yes
No

Section: Medical Records
Medical Records
3.27 The purpose of this section is to ensure that all PACE applicants maintain medical records in accordance with accepted
professional standards consistent with the requirements of 42 CFR §460.210.
1. Applicant agrees to maintain a single, comprehensive medical record for each
participant.

Yes
No

2. Applicant ensures that the health information management policy has procedures that
govern the maintenance of a single comprehensive medical record for each participant that
is:
Complete regardless of format (electronic or print);
Accurately documented;
Readily accessible to authorized personnel;
Systematically organized to facilitate review;
Available to employed or contracted staff; and
Maintained and housed at the PACE center where the participant receives services.
3. Applicant agrees to promptly transfer copies of pertinent medical record information to
all providers delivering direct care in other healthcare settings per HIPAA.

Yes
No

Yes
No

4. Applicant's medical records are appropriately authenticated by ensuring the following:
All entries must be legible, clear, complete, and appropriately authenticated and
dated; and
Authentication must include signatures or a secured computer entry by a unique
identifier of the primary author who has reviewed and approved the entry.

Yes
No

Section: Quality Assessment Performance Improvement Program (QAPI)
Quality Assessment Performance Improvement Program (QAPI)
3.28 The purpose of this section is to ensure that all PACE applicants take appropriate actions to improve performance, including
the establishment and operation of a QAPI in accordance with 42 CFR §460, Subpart H, §460.200, and §460.202.
1. Applicant agrees to do the following as specified in 42 CFR §460.130:
Develop, implement, maintain and evaluate a QAPI program;
Reflect the full range of services furnished by the PO; and
Take action resulting in improvements in its performance in all types of care.

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Yes
No

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2. Applicant agrees to use data collected through the health information system to identify
areas for improvement in the delivery of services, quality, and safety across care domains
(PACE center, home, inpatient, outpatient, rehabilitative etc.) as specified in 42 CFR
§460.136 by doing the following:
Using a set of outcome measures to identify areas of good or problematic
performance;
Taking actions targeted at maintaining or improving care based on outcome
measures;
Incorporating improvements into standard practice to sustain performance;
Prioritizing performance improvement activities based on clinical outcomes,
prevalence of the problem in the PACE population, and severity of the problem; and
Immediately correcting an identified problem that directly or potentially threatens
the health or safety of participants.

Yes
No

3. Applicant agrees that the designated QAPI coordinator will do the following as specified
in 42 CFR §460.136:
Coordinate and oversee implementation of the QAPI activities; and
Encourage PACE participants and caregivers to participate in QAPI activities,
including providing information about their satisfaction with services.
4. Applicant ensures that the IDT, PACE staff, and contract providers are involved in the
development and implementation of QAPI activities and are aware of the results of these
activities as specified in 42 CFR §460.136.

Yes
No

Yes
No

5. Applicant agrees to have one or more committees with community input to do the
following as specified in 42 CFR §460.138:
Evaluate outcome data measuring quality performance;
Address the implementation of the QAPI plan and the results from quality
improvement activities; and
Provide input related to ethical decision-making on issues such as end-of-life,
participant self-determination, and other participant health rights and concerns.
6. Applicant agrees to meet the external quality assessment and reporting requirements
specified by oversight agencies including, but not limited to, CMS and the SAA by using the
established health information system as specified in 42 CFR §460.140.

Yes
No

Yes
No

7. Applicant agrees to submit, upon request from CMS and/or SAA, data to monitor its
operations, costs, quality, and effectiveness of care as specified in 42 CFR §460.200.

Yes

8. Applicant ensures a health information system to collect, analyze, integrate, and report
data to measure the organization's performance as specified in 42 CFR §460.202.

Yes

9. Applicant agrees to submit to CMS all monitoring data elements specified in the PACE
program agreement to be reported quarterly or seasonally through the CMS Health Plan
Management System (HPMS) as specified in 42 CFR §460.202.
10. Applicant ensures a written QAPI plan as specified in 42 CFR §460.132.

No

No
Yes
No
Yes
No

B.In the Documents Section, upload a copy of the applicant's QAPI plan.
Note: The QAPI plan must be developed in accordance with 42 CFR §460.132.

Section: State Attestations
State Attestations
3.29 The purpose of this section is to ensure that the state is willing to enter into a PACE program agreement with the applying
entity, and that it has processes in place to ensure compliance with its obligations under the program (42 CFR §460.12 (b)).
1. Applicant has assurance from the SAA of the state in which the program is located
indicating that the state considers the entity to be qualified to expand its PACE program
and is willing to amend its existing PACE program agreement with the entity.

Yes
No

B. In the documents section upload the State Assurances document signed by an authorized official from the State agency
responsible for administering a PACE program agreement.
Note: The document should include the written name and title of the official and the name of the State agency.

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C. In the documents section upload the state's CMS-approved Medicaid capitation payment amount as described in 42 CFR
§460.182.
Note: If more than one capitation payment is applicable, please identify by cohort.

D. In the documents section upload a description of the state's procedures for any adjustment to account for the difference
between the estimated number of participants on which the prospective monthly payment was based and the actual number of
participants in that month, as required at 42 CFR §460.182(d).

E. In the documents section upload a description of the state's process for enrollment of participants into the state system,
including the criteria for deemed continued eligibility for PACE in accordance with 460.160(b)(3).

F. In the documents section upload a description of the state's process to oversee the applicant's administration of the criteria for
determining if a potential PACE enrollee is safe to live in the community at the time of enrollment.

G. In the documents section, upload a description of any information provided by the State to participants.

H. In the documents section upload a description of the state's process for disenrollment of participants from the state's system.

Section: Waivers
Waivers
3.30 PACE organizations are permitted to submit waiver requests consistent with 42 CFR §460.26 and 42 CFR §460.28.
1. Applicant is requesting specific modifications or waivers of certain regulatory provisions
as part of this application as permitted under Section 903 of the Benefits Improvement and
Protection Act (BIPA) of 2000.
2. Applicant ensures that specific modifications or waivers of certain regulatory provisions
as part of this application have been submitted to the SAA for review as specified in 42 CFR
460.26.

Yes
No
Yes
No
N/A

B. If you are submitting a waiver request in conjunction with your application, please upload a copy of your waiver request, in the
Documents section. Your request should include: Identification of the regulatory section the applicant is requesting to have waived;
the rationale behind the waiver request; if applicable, process(es), policies and procedures that will be followed to ensure
participant care is not compromised; and a State letter indicating the State's concurrence, concerns and conditions related to the
waiver request. Please note that the waiver request is reviewed separately from the application process itself.

Section: Application Attestation
Application Attestation
3.31 Applicants are required to upload a completed and signed attestation certifying that all information and statements made in
the application are true, complete, and current to the best of their knowledge and belief and are made in good faith.

A. Please upload your application attestation document.

Section: State Readiness Review
State Readiness Review
3.32 Applicants are required to submit a State Readiness Review of their PACE center.

A. Please upload your State Readiness Review.
Note: The State Readiness Review upload is required for initial PACE applications and SAE applications that include a new PACE
center. The State Readiness Review may be submitted in response to a request for additional information if not available at the
time of application submission. If applying for an SAE with no new PACE Center, the upload is not required.

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