CMS-10631 HPMS_ Initial PACE Application

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

HPMS_ Initial PACE Application

Application Requirements (POs)

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3/31/2020

HPMS: PACE Attestations

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PACE Attestations
Selected Contract #: Z1234 TEST CONTRACT NUMBER
Application Type: Initial
Organization Type: National PACE
Plan Type: National PACE

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 §460.12, §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 service area 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. Service area expansion applications that include a geographic
expansion must clearly distinguish the proposed expansion area from the currently-approved service area.
Note: The map must be developed in accordance with 42 CFR §460.12, §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(a)).

Yes

3. Applicant agrees that the Medical Director is responsible for delivery of participant care,
clinical outcomes and implementation and oversight of the quality improvement program
(42 CFR §460.60(b)).
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(c)).
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(c)(3)).

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No

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

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7. For any planned change in ownership, the applicant agrees to comply with all
requirements in 42 CFR part 422, subpart L, and must notify CMS and the SAA, in writing,
at least 60 days before the anticipated effective date of the change (42 CFR §460.60(d)).

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 PACE organization, 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
A quality improvement program.

Yes
No

(See 42 CFR §460.62(a)(7).)
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(a).

Section: Fiscal Soundness
Fiscal Soundness
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.
1. Applicant agrees to maintain 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).

2. Applicant agrees to provide CMS a copy of the signed "Subordinated/Guaranteed Debt
Attestation" form for each financial reporting period (if applicable).

Yes
No

Yes
No
N/A

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3. Applicant agrees to upload a documented plan in the event of insolvency as specified in
42 CFR §460.80(b).

Yes

4. Applicant agrees to provide CMS and the SAA accurate financial reports as specified in
42 CFR §460.204.

Yes

5. Applicant agrees to submit quarterly and annual certified financial statements in a
format acceptable to CMS and the SAA as specified in 42 CFR §460.208.

Yes

6. Applicant agrees to provide any reserve requirements and other financial requirements
set by the State in which the applicant proposes to operate its PACE program, and any
supporting documentation necessary to demonstrate how the applicant meets these
requirements (if applicable).

Yes

No

No

No

No
N/A

B. In the Documents Section, upload the independently audited financial statements for the three most recent fiscal year periods
or, if operational for a shorter period of time, for each operational fiscal year.
Note: If the PACE legal entity (applicant) is a line of business of the parent organization, and audited annual financial statements
are not available at the PACE legal entity level, the applicant may provide audited statements relating to the parent organization.
The applicant may also upload independently audited financial statements of guarantors and lenders (e.g. organizations providing
loans, letters of credit or other similar financing arrangements, excluding banks), if audited financial statements are not available
for either the legal entity or the parent organization.
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, provide the most recent year-to-date unaudited financial statements of the PACE applicant legal
entity or, if unavailable, for the parent organization, guarantors or lenders.

D. In the Documents Section, provide financial projections.
Note: Provide financial projections beginning with program commencement 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 the 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 PACE organizations.

E. In the Documents Section, upload the "Subordinated/Guaranteed Debt Attestation Form" (if applicable).
Note: Subordinated debt is defined as an unsecured debt whose repayment to its parent organization ranks after all other debts
have been paid when the subsidiary files for bankruptcy. Guaranteed debt is defined as secured debt in which another entity
promises to pay a loan or other debt if the organization that borrowed the money fails to pay. If subordinated/guaranteed debt 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). Please submit a detailed description, including the name and nature of the subordinated/guaranteed debt amount.

F. In the Documents Section, provide your Insolvency Plan.

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G. In the Documents Section, upload documents that demonstrate the applicant can, in the event it becomes insolvent, cover
expenses of at least the sum of one month's total capitation revenue to cover expenses the month prior to insolvency and one
month's average payment to all contractors, based on the prior quarter's average payment, to cover expenses the month after the
date insolvency is declared or operations cease. (Arrangements to cover expenses may include, but are not limited to, insolvency
insurance or reinsurance, hold harmless arrangements, letters of credit, guarantees, net worth, restricted state reserves or State
law provisions.) (42 CFR §460.80)

H. In the Documents Section, upload a description of any reserve requirements and other financial requirements set by the State
and supporting documentation to demonstrate how the applicant meets these requirements (if applicable).

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 the PACE Marketing Guidelines.
1. Applicant agrees to follow the PACE 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.

Yes
No

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 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, per 42 CFR §460.82(c).
5. Applicant agrees to submit marketing material, as outlined in the PACE Marketing
Guidelines, to the HPMS module and obtain CMS Regional Office and SAA 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):
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
PACE organization, CMS, or the SAA;
Gifts or payment to induce enrollment; and
Marketing by any individual or entity that is directly or indirectly compensated by
the PACE organization based on activities or outcomes unless the individual or
entity has been appropriately trained on PACE program requirements; and
Unsolicited door-to-door marketing.
7. 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

NOTE: PACE organizations are no longer required to submit marketing materials as a part of their application. PACE organizations
may begin submitting marketing materials for review after the application has been submitted and the PACE organization gains
access to the HPMS Marketing Module. If a PACE organization does not have an executed contract with CMS, any submitted and
approved marketing materials will be considered as conditionally approved, pending the outcome of the application 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 PACE organization has received the amended program agreement, accompanied by an approval letter from
CMS.

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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 §460.82, §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 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, per 42 CFR §460.82(c);
and
Display the PACE participant's rights in a prominent place in the PACE center as
specified in 42 CFR §460.116(c).

Yes
No

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(c)).

Yes
No

2. Applicant agrees to document all expressions of dissatisfaction with service delivery or
quality of care furnished, whether written or oral.

Yes

3. Applicant agrees to provide participants with written information of the grievance
process upon enrollment, and at least 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 with and provide to the participant in writing the specific
steps that will be taken to resolve the grievance, including timeframes for a response (42
CFR §460.120(e)).
6. Applicant agrees to maintain, aggregate and analyze information on grievance
proceedings, and use this information in its internal quality improvement program (42 CFR
§460.120(f)).

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No

No

No
Yes
No
Yes
No

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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.
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

Yes
No
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 its internal quality improvement 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 or maintain 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 §460.122(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 §460.122(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.

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Yes
No

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

Yes
No

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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 the policies and procedures should
specify whether the timeframes for responding to appeals are calendar days or business days.
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 the policies and procedures should specify whether
the timeframes for responding to appeals are calendar days or business days.
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.
1. Applicant agrees to enroll individuals who meet all of the following eligibility
requirements as specified in 42 CFR §460.150(b), 42 CFR §460.150(c) and §460.150(d):
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.

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 most current list of contracted staff who deliver
PACE services;
Discloses required monthly premium if applicable;
Discloses Medicaid spend-down obligations if applicable;
Discloses post-eligibility treatment of income if applicable;
Requires a signed release form from potential participant to allow the PACE
organization to obtain medical, financial, and Medicare and Medicaid eligibility
information;
Requires assessment by the SAA to determine eligibility for nursing facility services
(NF) level of care coverage under the State Medicaid Plan; and
Requires assessment by the PACE staff to determine if the potential participant can
be cared for appropriately in a community setting and that the individual meets all
PACE eligibility criteria.

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.

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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 reason for the denial; and
Notify CMS and SAA in the form and manner specified by CMS 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 that indicates the individual is a PACE participant and
includes the PACE phone number; and
Emergency information to be posted in the participant's residence explaining PACE
membership and how to access emergency services.
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.
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

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. If not applicable, please enter N/A in the required
document upload template document.
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

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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 quality improvement 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,
effective the first day of the month following the date the participant's notice of voluntary
disenrollment is received.

Yes
No

Yes
No

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(b) and 42 CFR §460.164(c):
Participant, after a 30 day grace period, fails to pay, or to make satisfactory
arrangements to pay, any premium due the PACE organization;
Participant, after a 30 day grace period, fails to pay, or make satisfactory
arrangement 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.
Participant moves out of the PACE program service area or is out of the service area
for more than 30 consecutive days, unless the PACE organization 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; and
Participant or participant's caregiver engages in disruptive or threatening behavior.
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 or a participant's caregiver with disruptive
or threatening behavior as specified in 42 CFR §460.164(d) 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(e).
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(f).

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,
as 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
within 30 days; and
Work with CMS and SAA to reinstate the participant in other Medicare and Medicaid
programs for which the participant is eligible.

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Yes
No

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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

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.
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 or, if the individual
has less than 1 year of experience but meets all other requirements specified in 42
CFR §460.64, must receive appropriate training from the PACE organization on
working with a frail or elderly population upon hiring;
Meet a standardized set of competencies for the specific position description
established by the applicant 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 42 CFR §410.20.
2. Applicant agrees to provide training to maintain and improve the skills and knowledge of
each staff member with respect to the individual's 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.
3. 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 as specified in 42 CFR §460.71(a)(1).
4. 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).
5. 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

6. 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 medically cleared for 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 PACE organization.

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Yes
No

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7. Applicant agrees to develop a training program as specified in 42 CFR §460.71(c) 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 §460.71(d).

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 individuals or contract with organizations or 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;
Whose contact with participants would pose a potential risk because the individual
has been convicted of one or more criminal offenses related to physical, sexual,
drug or alcohol abuse or use, as determined by the PACE organization;
Who have been found guilty of abusing, neglecting, or mistreating individuals by a
court of law or who have had a finding entered into the State nurse aide registry
concerning abuse, neglect, mistreatment of residents, or misappropriation of their
property; or
Who have been convicted of specific crimes for any offense described in section
1128(a) of the Social Security Act.
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
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 PACE organization 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 quality improvement 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).

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No

No
Yes
No
Yes
No

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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.

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
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
Delivered in at least 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 at each PACE center as
specified in 42 CFR §460.98(c):
Primary care, including services furnished by a primary care provider as defined in
§460.102(c) 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.

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Yes
No

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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 provider 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.

Yes
No
Yes
No

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.

Yes
No

Yes
No

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 provider,
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).
(Note: One individual may fill two separate roles on the interdisciplinary team where the
individual meets applicable state licensure requirements and is qualified to fill the two roles
and able to provide appropriate care to meet the needs of participants.)
3. Applicant ensures that primary medical care is provided by a PACE primary care provider
as defined in 42 CFR §460.102(c)(1) who is responsible for the following as specified in 42
CFR §460.102(c)(2):
Managing participant medical situations; and
Overseeing the participant use of medical specialists and inpatient care.

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Yes
No

Yes
No

Yes
No

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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; and
Documents changes of participant's condition in the medical record consistent with
documentation policies established by the medical director.
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 initial 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 and completes the assessment in a timely manner
in order to meet the requirements in 460.104(b):
Primary care provider;
Registered nurse;
Master's level social worker;
Physical therapist;
Occupational therapist;
Recreation therapist or activity coordinator;
Dietitian;
Home care coordinator; and
Other professional disciplines as recommended by the IDT. (See 42 CFR
§460.104(a)(1), §460.104(a)(2) and §460.104(a)(3).)
3. Applicant ensures that IDT members conducting the initial assessments consolidate,
within 30 days of the date of enrollment, discipline-specific assessments into a single plan
of care for each participant (42 CFR §460.104(b)).

Yes
No

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)):
Primary care provider;
Registered nurse;
Master's level social worker; and
Other team members that the primary care provider, registered nurse and Master'slevel social worker determine are actively involved in the development or
implementation of the participant's plan of care.

Yes
No

5. Applicant ensures that IDT members conducting reassessments must 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.

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Yes
No

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6. 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/designated representatives for reassessment.

Yes
No

7. Applicant ensures that semi-annual reassessments are conducted face-to-face by the
applicable IDT members specified in 42 CFR §460.104(c).

Yes

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).

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 the integration of discipline-specific 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).

Yes
No

2. Applicant ensures that the plan of care satisfies the following, per 42 CFR §460.106(b):
Specifies care needed to meet the participant's medical, physical, emotional, and
social needs identified during assessment;
Identifies appropriate interventions for each care need and how each will be
implemented;
Identifies measurable outcomes to be achieved;
Utilizes the most appropriate interventions for each care need that advances the
participant toward a measurable goal and outcome and
Identifies how each intervention will be evaluated to determine progress in reaching
specified goals and desired outcomes.

Yes
No

3. Applicant ensures that the IDT members implement, 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

6. Applicant ensures that the participant and/or caregiver participate in the development,
review, and reevaluation of the care plan and ensure the participant's concerns are
addressed.

No

No

No
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 applicants 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.

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Yes
No
Yes
No

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3. Applicant ensures that restraints are used for a defined, limited period of time based
upon the assessed 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

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
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 PACE organization does not pay for emergency services as specified in 42
CFR §460.100(a).
3. Applicant agrees to provide for emergency services, in both inpatient and outpatient
settings, by a qualified emergency services provider, other than the PACE organization or
one of its contract providers, either in or out of the PACE organization'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 PACE organization, the PACE organization cannot be
contacted, or the PACE organization did not respond to a request for approval within 1 hour
after being contacted as specified in 42 CFR §460.100(e).

https://hpmsimpl.cms.gov/secure/contract_management/online_app_ma/tracking_info_view.asp

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

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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).

No

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.
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
Yes
No
Yes
No

4. Applicant agrees to provide nutritional support based on participant condition or
diagnosis 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.

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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 provide assistance to each participant in obtaining necessary
transitional care through appropriate referrals and supply new providers the participant's
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 SAA.
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 outcomes data;
Financial books and records;
Medical records; and
Personnel records.

Yes
No

3. Applicant ensures written policies and implementation of 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;
Ten years from the last entry date in the record or, for medical records of
disenrolled participants, 10 years after the date of disenrollment; or
Completion of litigation or associated resolution of claims, financial management
review or audit, if started before the expiration of the retention period.

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Yes
No

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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 Improvement
Quality Improvement
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 quality improvement program 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 an effective, data-driven quality
improvement program;
Reflect the full range of services furnished by the PACE organization;
Take action resulting in improvements in its performance in all types of care; and
Meet external quality assessment and reporting requirements, as specified by CMS
or the State administering agency, in accordance with §460.202.

Yes
No

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 quality improvement coordinator will do the
following as specified in 42 CFR §460.136:
Coordinate and oversee implementation of quality improvement activities; and
Encourage PACE participants and caregivers to participate in quality improvement
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 quality improvement activities and are aware of the
results of these activities as specified in 42 CFR §460.136.

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Yes
No

Yes
No

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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 quality improvement 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 submit, upon request from CMS and/or SAA, data to monitor its
operations, costs, quality, and effectiveness of care and to establish payment rates,
specified in 42 CFR §460.200(c).
7. 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.
8. Applicant agrees to submit data and information pertaining to its provision of participant
care in the manner, and at the time intervals, specified by CMS and the State administering
agency as specified in 42 CFR §460.202.
9. Applicant ensures a written quality improvement plan as specified in 42 CFR §460.132.

Yes
No

Yes
No
Yes
No
Yes
No
Yes
No

B.In the Documents Section, upload a copy of the applicant's quality improvement plan. Service area expansion applicants are to
upload a current description of their quality improvement program.
Note: The quality improvement plan must be developed in accordance with 42 CFR §460.132. A quality improvement program
must be developed in accordance with 42 CFR §460.134, including requirements in 42 CFR §460.120(f) and 42 CFR §460.122(i).

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, or, as applicable, is willing to amend the program agreement with a PACE organization applying to expand its service area
and/or add a PACE center site, 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 be a PACE organization and
is willing to enter into a 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.

C. In the documents section upload the state's CMS-approved Medicaid capitation payment amount, or the methodology used to
calculate the amount, as described in 42 CFR §460.182(b).
Note: If more than one capitation payment is applicable, please identify by cohort. If using the rate methodology, it must be
consistent with the methodology included in the state plan.

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, to include information
on how beneficiaries access the State’s Fair Hearings process.

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

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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
submitted in conjunction with this application have been submitted to the SAA for review
and approval, as specified in 42 CFR 460.26(a)(2).

Yes
No
Yes
No
N/A

B. If you are submitting a waiver request 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; and 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.

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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