Form CMS-10631 PACE Application

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

PACE Paper Application_Updates for 2019_CLEAN_30Day_Modified 02162018_Corrected3.5_For PRA Package_FINAL

Waiver Requests (States)

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PROGRAMS OF ALL-INCLUSIVE
CARE FOR THE ELDERLY
For all new applicants and existing PACE Organizations seeking to expand a service area

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services (CMS)
Center for Medicare (CM)
Medicare Drug and Health Plan Contract Administration Group
(MCAG)

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a collection of information unless it displays a valid OMB control number. The valid OMB control number for this
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80 hours and 50 hours per initial and service area expansion response, respectively, including the time to review
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Contents
1

GENERAL INFORMATION ................................................................ 5
1.1
1.2
1.3
1.4
1.4.1
1.5

Overview ..................................................................................................................... 5
Technical Support ....................................................................................................... 6
The Health Plan Management System (HPMS) ......................................................... 6
Submitting Notice of Intent to Apply (NOIA) ............................................................ 6
Protecting Confidential Information ........................................................................... 7
Application Determination and Appeal Rights ........................................................... 7

INSTRUCTIONS ................................................................................... 7
2.0
2.1
2.2
2.3
2.4

Overview ..................................................................................................................... 7
Types of Applications ................................................................................................. 8
Chart of Required Attestations and Uploads .............................................................. 8
Document (Upload) Submission Instructions ............................................................. 9
Part D Prescription Drug Benefit Instructions .......................................................... 10

3.0
3.1
3.2
3.3
3.4
3.4.1
3.4.2
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15
3.16
3.17
3.18
3.19
3.20
3.21
3.22
3.23
3.24
3.25
3.26

Administrative Requirements – Trial Period (SAE applicants only)........................ 10
Service Area .............................................................................................................. 11
Legal Entity and Organizational Structure ............................................................... 12
Governing Body ........................................................................................................ 13
Fiscal Soundness ....................................................................................................... 14
Initial Application ..................................................................................................... 14
Service Area Expansion Application ........................................................................ 17
Marketing .................................................................................................................. 18
Explanation of Rights ............................................................................................... 21
Grievances................................................................................................................. 21
Appeals ..................................................................................................................... 23
Enrollment................................................................................................................. 25
Disenrollment ............................................................................................................ 28
Personnel Compliance .............................................................................................. 30
Program Integrity ...................................................................................................... 32
Contracted Services .................................................................................................. 33
Required Services ..................................................................................................... 34
Service Delivery........................................................................................................ 36
Infection Control ....................................................................................................... 37
Interdisciplinary Team .............................................................................................. 38
Participant Assessment ............................................................................................. 40
Plan of Care............................................................................................................... 42
Restraints................................................................................................................... 43
Physical Environment ............................................................................................... 44
Emergency and Disaster Preparedness ..................................................................... 45
Transportation Services ............................................................................................ 45
Dietary Services ........................................................................................................ 46
Termination ............................................................................................................... 47
Maintenance of Records & Reporting Data .............................................................. 48

ATTESTATIONS .................................................................................. 10

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3.27
3.28
3.29
3.30
3.31
3.32

Medical Records ....................................................................................................... 50
Quality Assessment Performance Improvement Program (QAPI) ........................... 50
State Attestations ...................................................................................................... 52
Waivers ..................................................................................................................... 54
Application Attestation ............................................................................................. 54
State Readiness Review ............................................................................................ 54

Document Upload Templates............................................................... 55
4.1
Governing Body ........................................................................................................ 55
4.2
Legal Entity and Organizational Structure ............................................................... 55
4.3
Subordinated/Guaranteed Debt ................................................................................. 55
4.4
Explanation of Rights ............................................................................................... 56
4.5
Enrollment................................................................................................................. 56
4.6
Additional Enrollment Criteria ................................................................................. 56
4.7
Voluntary Disenrollment .......................................................................................... 56
Involuntary Disenrollment ........................................................................................ 56
4.8
4.9
Grievances................................................................................................................. 57
4.10 Appeals ..................................................................................................................... 57
4.11 Additional Appeals Rights ........................................................................................ 57
4.12 Quality Assessment and Performance Improvement Program (QAPI) .................... 57
4.13 Medicare and State Medicaid Capitation Payment ................................................... 58
4.14 State Enrollment/Disenrollment Reconciliation Methodology................................. 60
4.15 Termination ............................................................................................................... 62
4.16 SAA Enrollment Process .......................................................................................... 62
4.17 SAA Oversight of PO Administration of Safety Criteria ......................................... 62
4.18 Information Provided by State to Participants .......................................................... 62
4.19 State Disenrollment Process ..................................................................................... 62
4.20 State Attestations/Assurances Signature Pages ........................................................ 62
STATE ATTESTATIONS/ASSURANCES SIGNATURE PAGES ................................... 63
[Template for State Attestations/Assurances Document] ..................................................... 63
4.21 Applicant Attestation ................................................................................................ 66

READINESS REVIEW REPORT ................................................................... 68
READINESS CRITERIA .................................................................................. 70

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1
1.1

GENERAL INFORMATION
Overview

The Programs of All-Inclusive Care for the Elderly (PACE) is a pre-paid, capitated plan that
provides comprehensive health care services to frail, older adults in the community, who
are eligible for nursing home care according to State standards. PACE programs must
provide all Medicare and Medicaid covered services; financing of this model is
accomplished through prospective capitation of both Medicare and Medicaid payments.
CMS regulations at 42 CFR § 460.98(b) (2) require a PACE Organization (PO) to provide
PACE services in at least the PACE center, the home, and inpatient facilities. The PACE
center is the focal point for the delivery of PACE services; the Center is where the
interdisciplinary team (IDT) is located, services are provided, and socialization occurs with
staff that is consistent and familiar to participants. The PACE model of care includes, as core
services, the provision of adult day health care and interdisciplinary team (IDT) care
management, through which access to and allocation of all health services is managed.
Physician, therapeutic, ancillary and social support services are furnished in the participant’s
residence or onsite at a PACE Center. Hospital, nursing home, home health and other
specialized services are furnished in accordance with the PACE participant’s needs, as
determined necessary by the IDT. To provide PACE participants with flexibility regarding
access to quality care, CMS has allowed POs to offer some services in other settings which
are referred to as an alternative care setting (ACS). An ACS can be any physical location in
the PO’s CMS approved existing service area other than the participant’s home, an inpatient
facility, or PACE center.
Section 4801 of the Balanced Budget Act of 1997 (BBA)(Pub. L. 105-33) authorized
coverage of PACE under the Medicare program by amending Title XVIII of the Social
Security Act (“the Act”) and adding section 1894, which addresses Medicare payments and
coverage of benefits under PACE. Section 4802 of the BBA authorized the establishment of
PACE as a state option under Medicaid by amending Title XIX of the Act and adding section
1934, which directly parallels the provisions of section 1894. The regulations implementing
these PACE statutory requirements are set forth in 42 CFR Part 460.
The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000,
(BIPA) amended the PACE statute to provide authority for CMS to modify or waive certain
PACE regulatory provisions. CMS-1201-IFC, Programs of All-inclusive Care for the
Elderly (PACE); Program Revisions, published October 1, 2002, 67 FR 61496,
established a process through which existing and prospective POs may request a waiver of
Medicare and Medicaid regulatory requirements. On December 8, 2003, the Congress enacted
the MMA of 2003 (Pub. L. 108-173). Several sections of the MMA impact POs. Most
notably, section 101 of the MMA affected the way in which POs are reimbursed for providing
certain outpatient prescription drugs to any Part D eligible participant. As specified in
sections 1894(b)(1) and 1934(b)(1) of the Act, POs shall provide all medically necessary
services including prescription drugs, without any limitation or condition as to amount,
duration, or scope and without application of deductibles, co-payments, coinsurance, or other
cost sharing that would otherwise apply under Medicare or Medicaid.
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In 2006, CMS issued a final rule (71 FR 71244, Dec 8, 2006) that finalized both the PACE
interim final rule with comment period published in the Federal Register November 24, 1999
(64 FR 66234) and the PACE interim final rule with comment period published in the Federal
Register on October 1, 2002 (67 FR 61496). For a complete history of the PACE program,
please see 71 FR 71244 through 71248 (Dec. 8, 2006).
1.2

Technical Support

CMS conducts special training sessions for all new and existing PACE applicants. All
applicants are strongly encouraged to participate in these sessions, which are announced
via the Health Plan Management System (HPMS) and/or the CMS main website.
CMS Central Office (CO) staff are available to provide Health Plan Management System
(see Section 1.3, below) technical support to all applicants and answer questions during the
PACE application process. While preparing the application, applicants may send an email
by going to https://dmao.lmi.org/ and clicking on the PACE tab. Please note: this is a
webpage, not an email address.
1.3

The Health Plan Management System (HPMS)

A. HPMS is the primary information collection vehicle through which PACE applicants
will communicate with CMS during the application process, the Part D bid submission
process, and for reporting and oversight activities.
B. Applicants are required to enter contact and other information in HPMS in order to
facilitate the application review process. Applicants must promptly enter organizational
data into HPMS and keep the information up to date. These requirements ensure that
CMS has current information and is able to provide guidance to the appropriate
contacts within the organization. In the event that the application is approved and CMS
executes a 3-way program agreement with the applicant entity and the applicable State,
this contact information will also be used for frequent communications during the
operational period of the PACE program. Therefore, it is important that this
information be accurate at all times.
C. HPMS is also the vehicle used to disseminate CMS guidance to POs. This
information is then incorporated into the appropriate manuals. It is imperative for
POs to independently check HPMS memos and follow the guidance as indicated in
the memos.
1.4

Submitting Notice of Intent to Apply (NOIA)

Organizations interested in becoming a new PO must complete a nonbinding NOIA. CMS
will not accept applications from organizations that fail to submit a timely NOIA.
For new applicants, upon submitting the completed form to CMS, the organization will be
assigned a pending contract number (H number) to use throughout the application and
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subsequent operational processes.
Once a contract number is assigned, the applicant should request a CMS User ID. An
application for Access to CMS Computer Systems (for HPMS access) is required and can
be found at: https://applications.cms.hhs.gov. Upon approval of the CMS User ID
request, the applicant will receive a CMS User ID(s) and password(s) for HPMS access.
1.4.1 Protecting Confidential Information
Applicants may seek to protect their information from disclosure under the Freedom of
Information Act (FOIA) by claiming that FOIA Exemption 4 applies. The applicant is
required to label the information in question “confidential” or “proprietary” and explain
the applicability of the FOIA exemption it is claiming. When there is a request for
information that is designated by the applicant as confidential or that could reasonably be
considered exempt under FOIA Exemption 4, CMS is required by its FOIA regulation at
45 CFR 5.65(d) and by Executive Order 12600 to give the submitter notice before the
information is disclosed. To decide whether the applicant’s information is protected by
Exemption 4, CMS must determine whether the applicant has shown that: (1) disclosure
of the information might impair the government’s ability to obtain necessary information
in the future; (2) disclosure of the information would cause substantial harm to the
competitive position of the submitter; (3) disclosure would impair other government
interests, such as program effectiveness and compliance; or (4) disclosure would impair
other private interests, such as an interest in controlling availability of intrinsically
valuable records, which are sold in the market place. Consistent with our approach under
other Medicare programs, CMS would not release information that would be considered
proprietary in nature if the applicant has shown it meets the requirements for FOIA
Exemption 4.
1.5

Application Determination and Appeal Rights

Pursuant to 42 CFR 42 CFR §460.20, if CMS denies an application, CMS must notify the
entity in writing of the basis for the denial and the process for requesting reconsideration of
the denial.

2
2.0

INSTRUCTIONS
Overview

Applicants must complete the PACE initial and service area expansion application using
HPMS as instructed. All documentation must contain the appropriate CMS-issued contract
number.
In preparing a response to the prompts throughout this application, the applicant must
mark “Yes” or “No” or “N/A” in sections organized with that format. By responding
“Yes,” the applicant is certifying that its organization complies with the relevant
requirements as of the date the application is submitted to CMS, unless a different date is
stated by CMS.
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Throughout this application, applicants are asked to provide various documents and/or
tables in HPMS. All required documents to be submitted are specified at the end of each
attestation section; a chart of all required attestations and uploads is also included in
Section 2.3.
CMS strongly encourages PACE applicants to refer to the regulations at 42 CFR §460.
Nothing in this application is intended to supersede the regulations at 42 CFR §460. Failure
to reference a regulatory requirement in this application does not affect the applicability of
such requirement, and applicants are required to comply with all applicable requirements of
the regulations. Applicants must read HPMS memos and visit the CMS web site
periodically to stay informed about new or revised guidance documents.
2.1

Types of Applications

Initial Applications are for:


Applicants who are seeking to become a PO for the first time.

Service Area Expansion Applications are for:


2.2

Existing PACE organizations who are seeking to expand the service area of an existing
contract number. This includes an expansion of the currently-approved geographic
service area and/or the addition of a new PACE center site.
Chart of Required Attestations and Uploads

This chart (Chart 1) describes the required attestations and uploads for both initial and
service area expansion PACE applications. Note that SAE applicants must generally
respond to the same attestations, as well as upload all documents required of initial
applicants. (See Section 2.4, below, regarding upload submission instructions and
information specific to SAE applications.) The purpose of this chart is to provide the
applicant with a summary of the attestation topics.
Chart 1 - Required Attestations and Uploads
Attestation Topic

Section #

Service Area

3.1

Legal Entity and Organizational Structure

3.2

Governing Body

3.3

Fiscal Soundness

3.4

Marketing

3.5

Initial

SAE

Upload
Required
(Initial)

Upload
Required
(SAE)

X**

X**
(as
applicable)

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Explanation of Rights

3.6

Grievance

3.7

Appeals

3.8

Enrollment

3.9

Disenrollment

3.10

Personnel Compliance

3.11

Program Integrity

3.12

Contracted Services

3.13

Required Services

3.14

Service Delivery

3.15

Infection Control

3.16

Interdisciplinary Team

3.17

Participant Assessment

3.18

Plan of Care

3.19

Restraints

3.20

Physical Environment

3.21

Emergency and Disaster Preparedness

3.22

Transportation Services

3.23

Dietary Services

3.24

Termination

3.25

Maintenance of Records & Reporting Data

3.26

Medical Records

3.27

Quality Assessment Performance
Improvement Program (QAPI)

3.28

State Attestations

3.29

Waivers

3.30

Application Attestations

3.31

State Readiness Review

3.32

X
(as
applicable)

X***

X***
(as
applicable)

* Financial documentation is not a requirement of SAE applicants. However, applicants may be asked to
provide specific information 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.
** Marketing materials for both initial and SAE applications are captured separately, via the HPMS PACE
marketing module. Applicants must upload marketing materials in the HPMS marketing module for CMS/State
review and approval following application submission. Additional information regarding the marketing
materials associated with an application may be found in Section 3.5 of this application.
*** The State Readiness Review is required, but may or may not be uploaded as part of the initial submission
of the application; the State Readiness Review may be uploaded after the initial application submission,
subsequent to CMS’s request for additional information.

2.3

Document (Upload) Submission Instructions

Required upload documents must generally be grouped together in a zipped file before
uploading. The Readme files for both the PACE and Part D applications (found in the
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appropriate download templates) details which files to group together and which are to be
uploaded individually. Note that each succeeding upload overwrites any previous
upload. Therefore, when reuploading a grouped file, applicants MUST include ALL files in
the group in the reupload.
In addition, the Readme Files provide Naming Conventions for uploaded files. PACE
applicants must use these naming conventions, where applicable, and be sure to include the
assigned H number in the file name of all submitted documents.
2.4.1

Document (Upload) Instructions Specific to SAE Applications

While SAE applications previously only required a subset of attestations and uploads required
of initial applications, as identified in Chart 1 above, generally the same attestation and
upload requirements are now required of both initial and SAE applicants. One key exception
is Section 3.4 (Fiscal Soundness), which includes different attestation requirements for initial
and SAE applicants. In addition, while there is no required financial upload for a PACE SAE
application, an applicant may be asked to provide specific information as part of a request for
additional information. Documentation submitted in conjunction with initial and SAE
applications will be reviewed and incorporated as part of the amended program agreement
following approval of the application.
All applicants must upload a “State Attestations” document provided by an authorized official
of the State Administering Agency (SAA) to demonstrate that the SAA supports the
application. All initial applications and any SAE application that includes the addition of a
new PACE center require a State Readiness Review (SRR) of the new center. Note that SAE
applications that do not include a new PACE center site generally do not require a readiness
review; however, the SAA must consider whether the existing PACE center has the capacity
to adequately serve new potential participants who reside in the expanded geographic area.
SAAs may vary in their requirements for approval of the SAE under these circumstances.
2.4

Part D Prescription Drug Benefit Instructions

The Medicare Part D Application is to be completed by those newly forming POs that
intend to provide the Part D benefit to eligible participants. Applicants must use the current
Medicare Part D Application for new POs that can be accessed via the link below. CMS
will not accept or review in any way those submissions using prior versions of the
application.
The Medicare Part D Application for new POs can be found at:
http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugC
ovContra/RxContracting_ApplicationGuidance.html.

The Part D application must be submitted simultaneously with this PACE application
and both will be reviewed within the same timeframes.

3 ATTESTATIONS
3.0

Administrative Requirements – Trial Period (SAE applicants only)
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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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: LEGAL ENTITY
AND ORGANIZATIONAL STRUCTURE

YES

1. (SAE Only) 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.)
3.1

Service Area

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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: SERVICE AREA

YES

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).

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.
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C. In the Documents Section, upload 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.
3.2

Legal Entity and Organizational Structure

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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: LEGAL ENTITY
AND ORGANIZATIONAL STRUCTURE

YES

N/A

1. Applicant ensures that the corporate entity that signs the
Program Agreement has the legal authority to do so.
2. Applicant agrees that the Program Director is
responsible for oversight and administration of the entity
(42 CFR §460.60(b)).
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 PO
(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)).
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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.
8. Applicant ensures that they are organized to operate within
the state consistent with all applicable state laws.
9. If planning to do business as (d.b.a.) under a name that is
different from the name of the organization, applicant
attests that it has state approval for the d.b.a.
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.
3.3

Governing Body

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 PO operations and participant concerns consistent with the requirements of 42 CFR
§460.62.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: GOVERNING
BODY
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:

YES

• 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.
(see 42 CFR §460.62(a))
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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)).
B. In the Documents Section, upload a current list of the governing body members/board of
directors and their titles. SAE applicants must 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).
3.4

Fiscal Soundness

3.4.1 Initial Application
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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: FISCAL SOUNDNESS
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.

YES

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).

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

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.

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.

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, upload the most recent year-to-date unaudited financial
statements of the PACE applicant legal entity, or if unavailable, for the parent
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organization, guarantors or lenders.
D. In the Documents Section, upload 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
o Quarterly statements of revenues and expenses for legal entity
o 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
o State major assumptions in sufficient detail to allow an independent
financial analyst to reconstruct projected figures using only the stated
assumptions;
o Include operating and capital budget breakdowns;
o Address all periods for which projections are made and include inflation
assumptions;
o Justify assumptions to the extent that an independent financial analyst
would be convinced that they are reasonable; and
o Base justification on such factors as the applicant's experience and the
experience of other POs.

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 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, upload your Insolvency Plan.
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
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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).
3.4.2 Service Area Expansion Application
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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: FISCAL SOUNDNESS
4. 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

N/A

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.
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;
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• 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:

3.5



Marketing

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.

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A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: MARKETING

YES

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.
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 out-of-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.

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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 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.
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.

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3.6

Explanation of Rights

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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: EXPLANATION OF RIGHTS

YES

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).
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).
5. Applicant ensures that their procedures respond to and rectify a
violation of a participant's rights in 42 CFR §460.118.
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).
B. In the Documents Section, upload a copy of your Participant Bill of Rights.
3.7 Grievances
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.

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A. In HPMS, complete the table below:

YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: GRIEVANCES

YES

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)).
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).
3. Applicant agrees to provide participants with written
information of the grievance process upon enrollment, and
annually thereafter (42 CFR §460.120(b)).
4. Applicant agrees to furnish all required services to participants
during the grievance process (42 CFR §460.120(d)).
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)).
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)).
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.

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3.8

Appeals

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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: APPEALS

YES

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(d).

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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 72-hour 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)(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.
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.
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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.
3.9

Enrollment

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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: ENROLLMENT

YES

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.
2. Applicant agrees to comply with the requirements of 42 CFR
§460.150(d) and not restrict enrollment based on Medicare or
Medicaid eligibility.
3. Applicant agrees that the enrollment agreement minimally
includes the requirements as specified in 42 CFR §460.154.
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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.
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.
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.

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7. Applicant agrees to submit participant information to CMS and
SAA in accordance with established procedures as specified in
42 CFR §460.156(b).
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).
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.
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.
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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.
3.10

Disenrollment

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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: DISENROLLMENT

YES

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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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 non-compliant 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).

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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).
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(a)(b):
• 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).
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.
3.11

Personnel Compliance

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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A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: PERSONNEL
COMPLIANCE

YES

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-to-date prior to engaging in direct
participant contact.
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(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).

OMB Control Number: 0938-1326
Expires: TBD

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).
7. Applicant ensures that all staff (employed and contracted)
furnishing direct participant care services meet the following
as specified in 42 CFR §460.71, and
• 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.

3.12

Program Integrity

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.

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PROGRAM INTEGRITY

YES

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 individual’s 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).
3.13 Contracted Services
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: CONTRACTED SERVICES

YES

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.

OMB Control Number: 0938-1326
Expires: TBD

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.
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).
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).
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.
3.14 Required Services
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 §460.96.

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: REQUIRED SERVICES

YES

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.
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).

OMB Control Number: 0938-1326
Expires: TBD

3.15 Service Delivery
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: SERVICE
DELIVERY

YES

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).
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.
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.

OMB Control Number: 0938-1326
Expires: TBD

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.
3.16 Infection Control
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF
THE FOLLOWING STATEMENTS:
INFECTION CONTROL

YES

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

OMB Control Number: 0938-1326
Expires: TBD

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.
3.17 Interdisciplinary Team
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: INTERDISCIPLINARY TEAM

YES

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).

OMB Control Number: 0938-1326
Expires: TBD

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.
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).

OMB Control Number: 0938-1326
Expires: TBD

3.18 Participant Assessment
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PARTICIPANT ASSESSMENT

YES

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.
2. Applicant ensures that each participant receives an initial face-toface 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).)

OMB Control Number: 0938-1326
Expires: TBD

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)).
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.
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.
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.
8. Applicant ensures that unscheduled reassessments are conducted
face-to-face by the applicable IDT member.
9. Applicant ensures that there are explicit procedures for
performance of unscheduled reassessments requested by the
participant/caregiver (42 CFR §460.104(d)(2)).

OMB Control Number: 0938-1326
Expires: TBD

3.19 Plan of Care
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: PLAN OF
CARE

YES

1. Applicant ensures prompt integration of discipline-specific
assessments by the IDT into a comprehensive single plan of
care for each participant.
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.
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.
4. Applicant ensures that the IDT members continuously update
the care plan as participant health status changes and
communicate changes to all IDT members.
5. Applicant ensures that the IDT reevaluates the goals and
measurable outcomes of each participant's care plan at least
semiannually.
6. Applicant ensures that the participant and/or caregiver
participate in the development, review, and reevaluation of the
care plan.
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.
42

OMB Control Number: 0938-1326
Expires: TBD

3.20 Restraints
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.
A. In HPMS, complete the table below:
RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: RESTRAINTS

YES

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.

OMB Control Number: 0938-1326
Expires: TBD

3.21 Physical Environment
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE FOLLOWING
STATEMENTS: PHYSICAL ENVIRONMENT

YES

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.
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).

OMB Control Number: 0938-1326
Expires: TBD

3.22 Emergency and Disaster Preparedness
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 42 CFR §460.84, and §460.100.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: EMERGENCY AND
DISASTER PREPAREDNESS

YES

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 outof-network services and post-stabilization care services following
emergency services and provide coverage when services are preapproved 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).
3.23 Transportation Services
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.
45

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: TRANSPORTATION
SERVICES

YES

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).
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)(1).
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 hands-free 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. (SAE only) Applicant agrees that the transportation system has
been modified to accommodate the proposed service area/site
expansion.
3.24 Dietary Services
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.

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: DIETARY SERVICES

YES

1. Applicant ensures that meals are nourishing, palatable, wellbalanced, 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 ensures that each meal will meet the following
requirements consistent with the requirements of 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)).
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.
(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.
3.25 Termination
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.
47

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: TERMINATIONS

YES

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.
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.
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).
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.
3.26 Maintenance of Records & Reporting Data
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.

OMB Control Number: 0938-1326
Expires: TBD

A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: MAINTENANCE OF
RECORDS & REPORTING DATA

YES

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

OMB Control Number: 0938-1326
Expires: TBD

3.27 Medical Records
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.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: MEDICAL
RECORDS

YES

1. Applicant agrees to maintain a single, comprehensive medical
record for each participant.
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.
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.

3.28 Quality Assessment Performance Improvement Program (QAPI)
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.

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A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: QAPI

YES

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.
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.
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.

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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 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.
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.
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.
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.
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.
3.29 State Attestations
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)).

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A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: STATE
ATTESTATIONS

YES

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 PO and is willing to enter into a
PACE program agreement with the entity.
B. In the Document Section upload the State Assurances document signed
by an authorized official from the State agency responsible for
administering the 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 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.

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3.30

Waivers

PACE applicants are permitted to submit waiver requests consistent with 42 CFR §460.26
and 42 CFR §460.28.
A. In HPMS, complete the table below:

RESPOND ‘YES’ OR ‘NO’ TO EACH OF THE
FOLLOWING STATEMENTS: WAIVERS

YES

N/A

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.
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.
3.31 Application Attestation
Applicants are required 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.
3.32 State Readiness Review
Applicants are required to submit a State Readiness Review of their PACE center.
A. Please upload your State Readiness Review. Note: The State Readiness
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Review upload is required for initial PACE applications and SAE
applications that include a new PACE center. If applying for an SAE
with no new PACE Center, the upload is not required.

4 Document Upload Templates
4.1

Governing Body
GOVERNING BODY
NAMES AND CONTACT LIST

[Appendix A of Program Agreement]
1. Name of Program Director:
Telephone Number:
E-mail address:
2. Governing Body contact person:
Telephone Number:
E-mail address:
3. Governing Body members/Board of Directors:

* Serves as participant representative

4.2

Legal Entity and Organizational Structure
LEGAL ENTITY AND ORGANIZATIONAL STRUCTURE
[Appendix B of Program Agreement]

(Instruction: Describe 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.)
4.3

Subordinated/Guaranteed Debt

If the applicant has a subordinated/guaranteed debt arrangement, the applicant must
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complete the “Subordinated/Guaranteed Debt Attestation” form located at
https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/FSRR.html. This
completed form may be uploaded as part of the fiscal soundness part of the application (see
section 3.4.1).

4.4

Explanation of Rights
EXPLANATION OF RIGHTS
[Appendix D of Program Agreement]

(Instruction: Include a description of the Participant Bill of Rights.)

4.5

Enrollment
ENROLLMENT
[Appendix E of Program Agreement]

(Instruction: Describe 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.)
4.6

Additional Enrollment Criteria
ADDITIONAL ENROLLMENT CRITERIA
[Appendix F of Program Agreement]

(Instruction: Describe 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.) If not applicable,
please state.)
4.7

Voluntary Disenrollment
VOLUNTARY DISENROLLMENT
[Appendix G of Program Agreement]

(Instructions: Describe voluntary disenrollment policies and procedures.)
4.8

Involuntary Disenrollment
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INVOLUNTARY DISENROLLMENT
[Appendix H of the Program Agreement]

(Instructions: Describe involuntary disenrollment policies and procedures.)
4.9

Grievances
GRIEVANCES
[Appendix I of Program Agreement]

(Instructions: Describe policy and procedure for grievances. Note the policies and
procedures should specify whether the timeframes for responding to grievances are calendar
days or business days.)

4.10 Appeals
APPEALS
[Appendix I of Program Agreement]
(Instructions: Describe policy and procedure for the appeals process. Note: This process
must be developed in accordance with 42 CFR §460.122.)

4.11 Additional Appeals Rights
ADDITIONAL APPEALS RIGHTS
[Appendix J of the Program Agreement]
(Instructions: Describe policies and procedures for informing participants of their additional
appeals rights under Medicare and/or Medicaid, including the process for filing further
appeals.)
4.12 Quality Assessment and Performance Improvement Program (QAPI)
QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM (QAPI)

[Appendix K of Program Agreement]
(Instructions: Provide a detailed description of the QAPI plan. Note: The QAPI plan must
be developed in accordance with 42 CFR §460.132.)

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4.13 Medicare and State Medicaid Capitation Payment
MEDICARE AND STATE MEDICAID CAPITATION PAYMENT
[Appendix M of Program Agreement]
CMS makes a prospective monthly payment to the PO of a capitation amount
for each Medicare participant in the payment area. Based on sections 1894(d)
and 1853(n)(5) of the Act, prospective payments are made up of the pre-ACA
county rate (calculated pursuant to section 1853(k)(1) of the Act), unadjusted
for Indirect Medical Education (IME), and multiplied by the sum of the
individual risk score and the organization frailty score. The following is a brief
description of PACE payment and the differences between PACE payment and
payment for Medicare Advantage plans below.
County Rates
The prospective payment rates for PACE are based on the applicable amount
calculated under section 1853(k)(1) of the Act, unadjusted for IME.1 In
rebasing years, this rate is the greater of: 1) the county’s FFS rate for the
payment year or 2) the prior year’s applicable amount increased by the payment
year’s National Per Capita Medicare Advantage Growth Percentage. In nonrebasing years, this rate is the prior year’s applicable amount increased by the
payment year’s National Per Capita Medicare Advantage Growth Percentage.
To determine whether a given year is a rebasing year, and for rules applicable to
specific payment years, refer to the applicable Rate Announcement (available
online at: https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html)
Section 1853(k)(4) of the Act requires CMS to phase out indirect medical
education (IME) amounts from MA capitation rates. PACE programs are
excluded from the IME payment phase out under that section pursuant to
section 1894(d)(3).
Effective CY 2006 and subsequent years for MA organizations, CMS makes
advance monthly per capita payments for aged and disabled enrollees based on
the bidding methodology established by the MMA. See section 1854 of the Act.
POs are not required to bid, however, CMS also makes advance monthly per
capita payments to POs for their enrollees, based on the PACE county
benchmark amounts as the capitation rate.
Risk Adjustment

The applicable amount is the pre-Affordable Care Act rate, which is phased-out under the Affordable Care
Act for Medicare Advantage plans, with transition to a new benchmark methodology finalized nationwide in
CY2017. Pursuant to section 1853(n)(5) of the Act, the applicable amount calculated under section
1853(k)(1) continues to apply for PACE.

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For the final payment rate, the county rate for the PO is multiplied by the
individual participant risk score. Risk adjustment allows CMS to pay plans for
the risk of the beneficiaries they enroll, instead of an average amount for
Medicare beneficiaries. The individual participant risk score for Medicare
Advantage and PACE is calculated using a CMS–HCC model (community,
long-term institutionalized, End-Stage Renal Disease (ESRD) or new enrollee),
which is published in the annual Announcement of Calendar Year Medicare
Advantage Capitation Rates and Medicare Advantage and Part D Payment
Policies and Final Call Letter (Rate Announcement).
Section 1894(d)(2) of the Act requires CMS to take into account the frailty of
the PACE population when making payments to POs. Therefore, a frailty factor
is added to each individual’s risk score for PACE payment. Risk adjustment
predicts (or explains) the future Medicare expenditures of individuals based on
diagnoses and demographics. Because risk adjustment may not explain all of
the variation in expenditures for frail community populations, the frailty
adjustment is used to predict the Medicare expenditures of community
populations with functional impairments.
The frailty score added to the beneficiary’s risk score is calculated at the
contract-level, using the aggregate counts of ADLs among HOS-M survey
respondents enrolled in a specific organization who responded to the survey the
prior year. More information regarding the HOS-M can be found in section
10.30 in Chapter 10 of the PACE manual chapter, Quality Assessment and
Performance Improvement, located online at:
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/pace111c10.pdf
Because the CMS-HCC model adequately predicts the costs of beneficiaries
under age 55 or who are among the long-term institutionalized population,
frailty adjustments are added to the risk scores for community-based and shortterm institutionalized enrollees aged 55 and older. Updated frailty factors are
published in the Rate Announcement for the payment year in which they are
first used.
Additional Information
For additional, more detailed information about PACE Medicare payment,
please see the following documents:




Payments to Medicare Advantage Organizations, Chapter 8, Medicare
Managed Care Manual
Risk Adjustment, Chapter 7, Medicare Managed Care Manual
CMS publishes changes to the Medicare Advantage payment
methodologies in the Advance Notice of Methodological Changes for
Medicare Advantage (MA) Capitation Rates and Part C and Part D
Payment Policies (Advance Notice) in mid-February at
http://www.cms.gov/MedicareAdvtgSpecRateStats/ for public comment.
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The final payment methodologies are published in the Announcement of
Medicare Advantage Capitation Rates and Medicare Advantage and Part
D Payment Policies and Final Call Letter (Rate Announcement) on the
first Monday in April at the same website.
Medicare Part D
In order for POs to continue to meet the statutory requirement of providing
prescription drug coverage to their enrollees, and to ensure that they receive
adequate payment for the provision of Part D drugs, beginning January 1, 2006,
POs began to offer qualified prescription drug coverage to their enrollees who
are Part D eligible individuals. The MMA did not impact the manner in which
POs are paid for the provision of outpatient prescription drugs to non-part D
eligible PACE participants.
POs are required to annually submit two Part D bids: one for a Plan Benefit
Package (PBP) for dually eligible enrollees and one for a PBP for Medicareonly enrollees. The Part D payment to POs comprises several pieces, including
the risk adjusted direct subsidy, reinsurance payments, and risk sharing. With a
few exceptions, Part D payments are made to POs in the same manner as to
MA-PD and standalone PDP plans. The direct subsidy is risk adjusted.
Payments for eligible enrollees of either PBP will include a low-income
premium subsidy and a low-income cost-sharing subsidy for basic Part D
benefits. Payments for dually eligible enrollees will also include an additional
amount to cover nominal cost sharing amounts (“2% capitation”), and an
additional premium payment in situations where the PO’s basic Part D
beneficiary premium is greater than the regional low-income premium subsidy
amount.
[Insert PACE rates into chart]
Description of Rate (ex. Dual Eligible, Medicaid Only)

Amount of Rate

4.14 State Enrollment/Disenrollment Reconciliation Methodology
STATE ENROLLMENT/DISENROLLMENT RECONCILIATION METHODOLOGY

[Appendix N of Program Agreement]
(Instructions: Provide 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).)
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4.15 Termination
TERMINATION
[Appendix O of Program Agreement]
(Instruction: Provide a detailed termination plan. Note: The plan for termination must be
developed in accordance with 42 CFR §460.50 and §460.52.)
4.16 SAA Enrollment Process
SAA ENROLLMENT PROCESS
[Appendix P of program Agreement]
(Instructions: Provide 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).)
4.17 SAA Oversight of PO Administration of Safety Criteria
SAA OVERSIGHT OF PO ADMINISTRATION OF SAFETY CRITERA
[Appendix Q of Program Agreement]
(Instructions: Provide 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.)
4.18 Information Provided by State to Participants
INFORMATION PROVIDED BY STATE TO PARTICIPANTS
[Appendix R of Program Agreement]
(Instructions: Provide a description of any information provided by the State to
participants.)
4.19 State Disenrollment Process
STATE DISENROLLMENT PROCESS
[Appendix S of Program Agreement]
(Instructions: Provide a description of the state’s process for disenrollment of participants
from the state’s system.)
4.20 State Attestations/Assurances Signature Pages
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STATE ATTESTATIONS/ASSURANCES SIGNATURE PAGES
[Template for State Attestations/Assurances Document]
The purpose of this section is to ensure that the state is willing to enter into a PACE
program agreement with the entity, and that it has processes in place to ensure compliance
with its obligations under the program. Please upload the following assurances with all
blanks filled in and with the appropriate signature from the State Administering Agency.
State certifies that the entity described in this application is qualified to be a PACE provider
and operate in the proposed geographic service area.
State has elected PACE as part of its Medicaid State Plan which allows for operation of the
applicant within the state.
State of ______________________ is willing to enter into a program agreement with the
applicant.
PACE Center address for this application: _______________________________________
(enter N/A if an expansion application without a new PACE Center)
Service area for this application by county or zip codes, as
applicable: ____________________________________________________ (if an
expansion application, only enter the new service area being added).
State certifies that this PACE Organization will have an enrollment limit of
participants (if state enrollment limit applies).
State agrees to establish a process to ensure that all potential participants, including any
individual who is not eligible for Medicaid, are assessed to determine that he or she needs the
level of care required under the state Medicaid plan for coverage of nursing facility services.
(42 CFR §460.152(a)(3))
State agrees to establish a process to receive participant enrollment information from the
applicant for purpose of enrollment of Medicaid participants into the program. (42 CFR
§460.156 (b))
State agrees to establish a process to ensure that, at least annually, participants will be
evaluated to determine if the participant continues to need the level of care required under the
State Medicaid plan for coverage of nursing facility services. (42 CFR §460.160(b))
State agrees to establish a process that may permanently waive the annual recertification
requirement for a participant if it determines that there is no reasonable expectation of
improvement or significant change in the participant’s condition because of the severity of a
chronic condition or the degree of impairment of functional capacity.
When the state determines a PACE participant no longer meets the State Medicaid nursing
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facility level of care requirements, the State agrees to establish a process that may deem
participants to continue to be eligible for PACE until the next annual reevaluation if, in the
absence of continued coverage under the program, the participant reasonably would be
expected to meet the nursing facility level of care requirement within the next 6 months.
The State agrees to establish criteria to use in making the determination of deemed continued
eligibility.
The state agrees to make a determination of continued eligibility in consultation with the
applicant, based on a review of the participant’s medical record and plan of care.
The state agrees to oversee the applicant’s administration of the criteria for determining if a
potential PACE enrollee is safe to live in the community.
State agrees to establish a process to ensure that beneficiaries have access to the State’s Fair
Hearings process as an external appeal avenue.
State agrees that before an involuntary disenrollment is effective, the State administering
agency will review documentation and determine in a timely manner that the applicant has
adequately documented acceptable grounds for disenrollment. (42 CFR §460.164(e))
State agrees to establish a process to receive participant disenrollment information for
purposes of coordinating the disenrollment date between Medicare and Medicaid. (42 CFR
§460.166)
State agrees to ensure that it will work with CMS and the applicant to reinstate a disenrolled
participant in other Medicaid programs for which the participant is eligible. (42 CFR
§460.168)
State agrees to make a prospective monthly payment to the applicant of a capitation amount
for each participant. (42 CFR §460.182)
State agrees to ensure that the capitation amount:




Is less than what would otherwise have been paid under the state plan if the
participants were not enrolled in PACE
Takes into account the comparative frailty of PACE participants
Is a fixed amount regardless of changes in the participant’s health status

State agrees to establish procedures for the enrollment and disenrollment of participants in
the SAA’s system, including 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.
State agrees to cooperate with CMS in oversight and monitoring of the operations of the
applicant’s program to ensure compliance with PACE requirements. (42 CFR §460.190 and
42 CFR §460.192)
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State agrees that it will ensure that the Medicare benefit requirements are protected for
dually eligible PACE participants upon entering a facility, in accordance with 42 CFR
§460.90, including details on when and how Medicaid share of cost requirements are
imposed.
State certifies that the State Administering Agency will verify that the PACE Organization
has qualified administrative and clinical staff employed or under contract prior to furnishing
services to participants.

Printed name and title

Signature

Date

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4.21

Applicant Attestation
CENTERS FOR MEDICARE AND MEDICAID SERVICES
CENTER FOR BENEFICIARY CHOICES
CENTER FOR MEDICAID AND STATE OPERATIONS
PROVIDER APPLICATION
PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

NAME OF LEGAL ENTITY

MAILING ADDRESS

TRADE NAME (if different)

AREA CODE TELEPHONE NO. EXTENSION

FAX

CEO OR EXECUTIVE DIRECTOR:
NAME AND TITLE

MAILING ADDRESS

TELEPHONE NUMBER

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APPLICANT CONTACT PERSON:
NAME
TITLE
ADDRESS
E-MAIL
FAX
TELEPHONE NUMBER

I certify that all information and statements made in this application are true, complete, and current to the best of
my knowledge and belief and are made in good faith.

Signature, CEO / Executive Director

Date

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READINESS REVIEW REPORT
PACE ORGANIZATION:
H #:
DATE (S) OF REVIEW:
REVIEWER (S) – NAME, TITLE AND DEPARTMENT:
DATE OF COMPLETION:
STATE ADMINISTERING AGENCY:
SAA REPRESENTATIVE SIGNATURE:

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STATE READINESS REVIEW
CMS will only approve applications from potential PACE organizations that satisfy federal requirements as determined based on review of the PACE
application, and have met the requirements of a State Readiness Review (SRR). The SRR is performed by the state at the applicant’s PACE Center. At the
time of the SRR, the entity will not be operational and thus will have no enrolled participants. The purpose of this review is to determine the organization’s
readiness to administer the PACE program and enroll participants. The SRR will include a minimum set of criteria established by CMS in conjunction with
the States. The States are free to add any additional criteria to the readiness review based on state specific requirements or they deem necessary to help
them determine if the applicant: 1) meets the requirements stipulated in the PACE regulation; 2) has developed policies and procedures consistent with
the PACE regulation; and 3) has appropriate staffing and established contracts necessary to provide all-inclusive, quality care to its participants.
The SRR includes but is not limited to: A review of policies and procedures; the design and construction of the PACE center; emergency preparedness;
the site’s compliance with OSHA, FDA, State and local laws, and adherence to Life Safety Code requirements. There are several areas of the SRR that
defer to state and local laws and regulations for compliance. If the applicant’s state has more stringent laws and regulations, those laws will apply in
place of the federal requirement. However, it is incumbent upon the SRR team to ensure that their state laws or regulations encompass each of the items
identified in the federal requirement.
Upon completion of the SRR, the state will be responsible for preparing and submitting a completed SRR report ensuring that all required areas are met.

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STATE READINESS REVIEW REPORT
PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

PHYSICAL
ENVIRONMENT
(§460.72)
I.A.
The PACE Center
must be designed,
constructed,
equipped, and
maintained to
provide for the
physical safety of
participants,
personnel, and
visitors.

EVIDENCE OF COMPLIANCE WITH ALL STATE AND LOCAL
BUILDING, FIRE SAFETY AND HEALTH CODES.

 MET
 NOT MET

Visible evidence of the following:


Fire exit system



Doorways that provide adequate width to allow
easy access and movement of participants by wheelchair or
stretcher;



Doorways, hallways and stairways that provide access free
from obstructions at all times;



Lights and handrails in stairways, corridors, bathrooms, and at
exits used by participants;



Toilets and stalls in the public bathrooms that are accessible to
allow use by non-ambulatory and handicapped participants,
staff and visitors;

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET

NOTES

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PACE
REGULATION
REQUIREMENT

READINESS CRITERIA



Evidence of compliance with the ADA (28 CFR Part 36 Title
III).

Facility equipped with call lights for a
communication system that alerts staff of participant problems
in bathrooms, therapy areas, etc.
Design features to safeguard cognitively impaired clients who
may wander (e.g. fences, door alarms, detector bracelets, etc.)
and evidence the safeguards are operational.

Written plan that outlines scheduled maintenance for
the PACE center to include building maintenance.

CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET

 MET
 NOT MET
 Other

OTHER (SPECIFY)

(Specify and
Attach)

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
I. B.
The PACE Center
must ensure a safe,
functional, accessible
and comfortable
environment for the
delivery of services
to the participant.

READINESS CRITERIA
EVIDENCE OF CERTIFICATION OR LICENSURE BY THE
STATE OR A RECOGNIZED ENTITY FOR ADULT DAY
CENTERS THAT ENCOMPASSES APPROPRIATE CRITERIA.
Note: If the PACE Center is licensed as an adult day center by the
state, skip to 1.C.

CRITERIA MET

 MET
 NOT MET
 N.A.

Evidence of the following:


Written policies and procedures for ensuring an environment
that provides privacy and dignity for participants, i.e. doors
for exam rooms, privacy curtains, appropriate clothing and
linen to cover participants during treatment, etc.;



Lighting and sound levels in care areas, activity and dining
rooms that are appropriate for individuals with vision,
hearing, and cognitive impairments;



Proper ventilation;



Written policies and procedures for an effective pest control
program to control infestations by pests and rodents not
limited to roaches, ants, flies, and mice;



If applicable, designated areas for smoking that are clearly
marked and limited to participants and staff.

 MET
 NOT MET

 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET
N.A.

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET



Posted signs that prohibit smoking while oxygen therapy is
being administered and clearly designated universal oxygen
signs.



Written policies and procedures regarding smoking policies,
including how to determine if or when participants may
smoke with or without supervision (if applicable).



Written policies and procedures on the proper storage,
handling, and disposal of all chemicals, compounds and
biohazardous waste, including Material Safety Data Sheets for
any chemical, cleaning and medical supplies;

 MET
 NOT MET



Equipment stored in a manner to ensure participant’s safety at
all times.

 MET
 NOT MET

 MET
 NOT MET
 MET
 NOT MET

 Other
OTHER (SPECIFY)

(Specify and
Attach)

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
I. C.
The PACE Center
must include
sufficient suitable
space and equipment
to provide primary
medical care and
suitable space for
team meetings,
treatment, therapeutic
recreation, restorative
therapies,
socialization,
personal care, and
dining.

READINESS CRITERIA

CRITERIA MET

Evidence of Adequate Space For:
(Adequate space would be determined by the provisions, if any, that
are included in the PACE Center Life Safety Code building occupancy
license, and the projected attendance by participants)


Team meetings

 MET
 NOT MET



Medical treatment and other care

 MET
 NOT MET



Therapeutic recreation

 MET
 NOT MET



Restorative therapies

 MET
 NOT MET



Socialization

 MET
 NOT MET



Personal care

 MET
 NOT MET



Dining

 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

CRITERIA MET

READINESS CRITERIA

 MET
 NOT MET
Evidence of sufficient and maintained equipment for safely
transferring disabled participants on to exam tables and restorative
therapy treatment equipment, such as tubs, beds, etc.

 MET
 NOT MET

Evidence that all storage areas, including food storage, include
appropriate clearance from floors, ceilings and other structural
elements.

 Other
(Specify and
Attach)

OTHER (SPECIFY)

I. D.
The PACE
organization must
establish, implement
and maintain a
written plan to ensure
that all equipment is
maintained in
accordance with the
manufacturer’s
recommendations

A written maintenance plan that identifies the individual responsible
for the implementation and monitoring of the plan, what logs or
records will be required, what equipment is included, and the
maintenance schedules according to manufacturer’s recommendations.
A written plan and monitoring program to check all
related to maintenance agreements.

contracts

Written policies and procedures to ensure compliance with and report
device related death and serious injuries to the FDA and/or the

 MET
 NOT MET

 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
and keep all
equipment
(mechanical,
electrical, and patient
care) free of defect.
This includes any
equipment in the
patient’s home.

I.E.
The PACE center
must meet the
occupancy provisions
of the latest edition
of the LSC for the
type of setting in
which it is located

READINESS CRITERIA
manufacturer of the equipment in accordance with the Safe Medical
Devices Act of 1990.
Evidence of manufacturer’s manuals for all equipment (mechanical,
electrical, safety/emergency preparedness and patient care).

CRITERIA MET

 MET
 NOT MET
 Other

OTHER (SPECIFY)

(Specify and
Attach)

EVIDENCE OF COMPLIANCE WITH THE CURRENT EDITION
OF THE LIFE SAFETY CODE or state code that CMS determined
adequately protects participants and staff.

 MET
 NOT MET

In addition have evidence of a:
Fire Alarm System:
 Initiation
 Notification
 Control
 Air condition shutdown
 Automatic release of fire doors held open by magnetic devices
Staff training and drills specific to the PACE Center
Fire evacuation Plans specific to the PACE Center
Fire Procedures specific to the PACE Center

 MET
 NOT MET

OTHER (SPECIFY)

 Other
(Specify and

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET
Attach)

I.F.
Establish, implement,
and maintain
documented
procedures to
manage medical and
nonmedical
emergencies and
disasters that threaten
the health and safety
of participants, staff,
or visitors.
I.G.
PACE organization
must train all staff
(employees and
contractors) on the
actions necessary to
address different
medical and
nonmedical
emergencies.

I.H.

Evidence of:


Written policies and procedures to manage medical
emergencies, including responding to DNRs, or any other
advance directives; choking; chest pain; seizures; stopped
breathing or cessation of heart;

 MET
 NOT MET



Written policies and procedures(s) for the periodic
examination of all emergency drugs to confirm
expiration date(s) and inventory control;



Written policies and procedures for staff training and drills for
the PACE Center’s emergency procedures, including the use
of emergency drugs and emergency equipment;



At least one staff member during hours the center(s) have
participant’s present will be trained and certified in Basic Life
Support (CPR).

 MET
 NOT MET



Verify that emergency drugs and emergency equipment is
readily available, operating, and clean including:

 MET
 NOT MET

o
o
o
o

PORTABLE OXYGEN
AIRWAYS
SUCTION EQUIPMENT
PHARMACEUTICALS APPROPRIATE TO
STABILIZE PARTICIPANTS.

 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
The PACE Center
must have emergency
equipment, along
with staff who know
how to use the
equipment at the
center at all times
and immediately
available to
adequately support
participants until
emergency medical
assistance responds
to the center.

READINESS CRITERIA

CRITERIA MET

 MET
 NOT MET



Written policies and procedures to manage nonmedical
emergencies and any natural disasters affecting the center’s
geographic location, including:



Method of containment of fire;

 MET
 NOT MET

Evacuation plans and routes specific to the PACE Center;

 MET
 NOT MET

Adequate emergency lighting at exits and corridors;

 MET
 NOT MET



Plans for power outages, problems with water supply, and
transfer of participants to other sites that meet their special
needs;



Periodic drills specific to the PACE Center;



Plan for assuring the health and safety of participants at home
to ensure their continuing care needs will be met;

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 Other

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA


Facility structure and characteristics that will accommodate an
expedient and safe evacuation of staff, participants, and
visitors;

CRITERIA MET

(Specify and
Attach)

OTHER (SPECIFY)

INFECTION
CONTROL
(§460.74)
II.
At a minimum, the
PACE Center must
have an infection
control plan that
includes:
A. Procedures

Written policies and procedures for the investigation, control, and
prevention of infections including:

 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
to identify,
investigate, control,
and prevent
infections
in the PACE Center
and in each
participant’s place of
residence;

READINESS CRITERIA


 MET
 NOT MET
 MET
 NOT MET



B. Procedures to
record any incidents
of infection;
C. Procedures to
analyze the incidents
of infection, to
identify trends, and
develop corrective
actions
related to the
reduction of future
incidents.

A written OSHA Exposure Control Plan which includes the
Universal Precautions and Bloodborne Pathogen exposure
procedures for staff;

CRITERIA MET



Vaccinating participants and staff against diseases of
particular concern for the PACE participant and the PACE
Center’s geographic location, i.e. influenza and pneumonia
(are required minimally);
Initial and ongoing health screening and vaccinations for staff
and participants in accordance with OSHA regulations (staff)
and CDC guidelines for tuberculosis, Hepatitis B and other
communicable diseases.

Written policies and procedures for the investigation,
evaluation, resolution, and reporting of all incidences of staff
and participant infection.

Written policies and procedures for maintaining records of
staff and participant infections to include post-exposure
evaluation, training records, and participant and staff
surveillance reports.

 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

 MET
 NOT MET




Written policies and procedures for reporting required
communicable diseases to the appropriate federal, state and
local officials.

Policies and procedures for staff providing direct care to
patients with infection(s);

 MET
 NOT MET
 N/A
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 NA



Provision of adequate facilities and supplies necessary for
infection control to include:

 MET
 NOT MET
 Other

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET
(Specify and
Attach)



Hand washing facilities and supplies;



Laundry facilities and supplies if conducted at PACE
Center;



Isolation facilities and supplies



Written policies and procedures for addressing how laundry
will be handled. If the service is contracted out, written
agreements to comply with the requirements.



Written policies and procedures for the ongoing monitoring of
the contractual agreement provisions for laundry and waste
disposal.

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA



Written policies and procedures for the appropriate handling
and disposal of all waste products including blood and urine
specimens for outside lab tests and other biohazardous
wastes.

OTHER (SPECIFY)

Transportation
Services (§460.76)

CRITERIA MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
III.
The PACE
organization should
take appropriate steps
to ensure that
participants can be
safely transported
from their homes to
the PACE Center and
to appointments.
A. Requirements for
the organization’s
transportation
program include:
1. Maintenance of
transporta-tion
vehicles
according to the
manu-facturer’s
recommendations.
2. Transportation
vehicles
equipped to
communicate
with the PACE
Center.
3. Training
transportation
personnel on the

READINESS CRITERIA

CRITERIA MET

Evidence of appropriate state vehicle inspections.

 MET
 NOT MET

If commercial vehicles (greater then 12 seats, usually) are being used,
a commercial license is required by all drivers.

 MET
 NOT MET

If the service is contracted out, written agreements to comply with the
contract requirements under §460.70.

 MET
 NOT MET
 NA

Written policies and procedures for the ongoing monitoring of the
contractual agreement provisions for transportation services.

 MET
 NOT MET
 NA

Evidence of the ability to provide adequate and safe transportation of
center participants:


Sufficient staff



Written policies and procedures for the training and
monitoring of drivers including:


Proper transfer of nonambulatory and ambulatory
participants;






MET
NOT MET
MET
NOT MET

 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
special needs of
participants and
appropriate
emergency
responses.
4. As a part of the
multidisciplinary
process,
communica-ting
relevant changes
in the
participant’s care
plans to
transportation
personnel.

READINESS CRITERIA




Proper use of equipment needed to transfer and secure
participants;

Emergency procedures during transfer, transport, and
arrival of participants.

CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET



Ability for communication between the driver and PACE
Center during transportation activities.

 MET
 NOT MET



Evidence of written policies and procedures on the
maintenance of vehicles utilized in the transport of
participants.

 MET
 NOT MET



Written policies and procedures for communication between
the multidisciplinary team and the transport staff regarding the
needs of the participants being transported.



Written policies and procedures for monitoring the
performance of all drivers.



Written policies and procedures regarding smoking or nonsmoking on transportation vehicles, and appropriate signage
based on policy.

 MET
 NOT MET
 MET
 NOT MET

 Other
(Specify and

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA



CRITERIA MET
Attach)

Written procedures to check or audit for the following
information on the drivers:
 Current driver’s license
 Record of any traffic violations or accidents that may
constitute a potential hazard for the transport of
participants.

OTHER (SPECIFY)

Dietary Services
(§460.78)
IV.
PACE Center is
required to provide
food that is
nourishing, palatable,
well-balanced, and
meets acceptable
safety standards:

Evidence of certification or licensure from state or local
health agencies for the preparation and/or serving of food (including
the last Department of Health Inspection).
Written policies and procedures that ensure the safe
delivery of food and nutritional supplements including:


Safe procurement of food and nutritional supplements;









MET
NOT MET
N.A.
MET
NOT MET
MET
NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
A. Procure food
from sources
approved or
considered
satisfactory by
federal, state, tribal
or local authorities
that have jurisdiction
over the service area;
B. Store, prepare,
distribute, and serve
food under sanitary
conditions;

READINESS CRITERIA




Safe storage of food and nutritional supplements both
perishable and nonperishable to prevent contamination (at
required temperatures – freezer below 0 degrees F or below
and refrigerator 41 degrees or below);

CRITERIA MET

 MET
 NOT MET

Safe handling of food and nutritional supplements;

 MET
 NOT MET


Safe preparation of food and medication, including policies
for admixtures;



Safe and adequate water supply;

C. Dispose of
garbage and refuse
properly

 MET
 NOT MET



Provisions for substitute foods or nutritional supplements;



Safe garbage storage and disposal;



Training of staff in safe food delivery; and

 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA



Written policies and procedures for emergency food supplies
and emergency nutritional supplements.

CRITERIA MET

 MET
 NOT MET

Written policies and procedures for dietitian, physician, and
pharmacist involvement to determine the nutritional adequacy of
menus and the caloric and nutritional needs for the participant
population.
OTHER:

Bill of Rights
(§460.110)
V.
The PACE
organization must
have written policies
and implement
procedures to ensure
that the participant,
his or her

Written policies and procedures governing the participant Bill of
Rights including:


The parameters on the use of physical or chemical restraints;



The reporting of mental or physical abuse or neglect.

 MET
 NOT MET





MET
NOT MET
MET
NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
representative, and
staff understand their
rights.

READINESS CRITERIA
Written policies and procedures for distributing the Bill of Rights to
the participant and his or her representative upon enrollment and
annually.
Written policies and procedures to ensure that the participant, his or
her representative, and staff understand participant rights.
The participant PACE Bill of Rights should be in English and any
other principal language of the community and be displayed in an area
frequented by the public.
Evidence of compliance with State requirement, if any, for specific
criteria of the principle language
The participant Bill of Rights should be in a large print for the elderly
to read.

CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET

Written policies and procedures to respond to and
rectify a violation of a participant’s rights.

 MET
 NOT MET

OTHER (SPECIFY)

 OTHER
(Specify and
Attach)

Personnel
Qualifications
(§460.64)

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
VI.
The PACE Center
must have qualified
staff to provide care
to its frail elderly
participants.

READINESS CRITERIA
Assurance by the State that contracts for all contractors and contracted
personnel are executed by the time the PACE center becomes
operational.

Written position descriptions for all staff (employees and contractors).
Assuranceby the State that the required members of the
multidisciplinary team (primary care physician, registered nurse,
social worker, recreational therapist or activities coordinator, PACE
center manager, home care coordinator, and PACE center personal
care attendants, drivers) are/will be employees or contractors of the
PACE center by the time the PACE center becomes operational.
Evidence that appropriate professional licenses/certifications have
been verified by primary source (licensing/certification board) and
background checks have been done on all staff – employees and
contractors (per state law requirements). If no direct participant care
employees are yet hired then this review would entail the evidence of
the procedures that will be completed to comply with this area.

CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET

OTHER (SPECIFY)

 Other
(Specify and
Attach)
TRAINING AND
COMPETENCY
(§460.66 AND

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

§460. 71)

VII.
A. The PACE
organization must
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.
B. The PACE
organization must
develop a training
program for each
personal care
attendant to establish
the individual’s
competency in
furnishing personal
care services and

Written individual competency and training programs for all team
positions, specific to each position that includes at least the following:


Competency program to ensure that each staff member
initially and ongoing demonstrates competency in the skills
needed to provide appropriate, culturally competent care to
participants. The competency program must include:




 MET
 NOT MET
 MET
 NOT MET

Initial hires and ongoing skills demonstration;

 MET
 NOT MET
Skills demonstration method of evaluation based on
standard protocols;



Competent evaluator (including peer evaluator);



Skills that reflect scope of practice and appropriate for the
PACE Center, home setting and level of care.

Training should be specific and within the scope of practice.
To include at least the following:

 MET
 NOT MET
 MET
 NOT MET





MET
NOT MET
MET
NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT
specialized skills
associated with
specific care needs of
individual
participants.

READINESS CRITERIA


Training and demonstrated competency on the transport
of nonambulatory participants for drivers and any other
applicable staff;



Training and demonstrated competency on all emergency
equipment and all other equipment necessary for the
performance of his or her specific position;



Training and demonstrated competency on center
emergency procedures;



CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET

Training and demonstrated competency on restraint use;



Training and demonstrated competency on participant
rights, including dignity and privacy, to all participants;



Training and demonstrated competency in response to
participant grievances or center quality improvement
activities; and

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET



Training and demonstrated competency in therapeutic
communication specific to the PACE setting and
population.

Written training manual for personal care attendants to ensure that
they exhibit competency in basic skills for providing personal care,

 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA
including:





How to maintain a clean, safe and healthy environment;

Appropriate and safe techniques in personal hygiene and
grooming;

Safe transfer techniques and ambulation;

Observation, reporting, and documentation of patient status
and the care or service furnished.

Training in therapeutic communication specific to the PACE
setting and population; and

Other elements consistent with their assigned duties.

OTHER (SPECIFY)

CRITERIA MET

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET
 Other
(Specify and
Attach)

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

CRITERIA MET

GENERAL
PROVISIONS
VIII.
General provisions

Evidence of all current licensure required in the State:
 ADHC
 Home Health
 Clinic
 HMO
 Ambulatory Care Center
 Other - specify
Written policies and procedures regarding the safeguarding of
participant data and records according to HIPAA compliance for
security (electronic and paper).
Written plans and procedures regarding the confidentiality and
retention of participant health information.
Written plan and procedures for all participant reassessments which
include periodic reassessments and reassessments at the participant or
caregiver’s request.

 MET
 NOT MET
 N/A

 MET
 NOT MET
 MET
 NOT MET
 MET
 NOT MET

 MET
 NOT MET
Verify the PACE organization’s actual service area.

 MET
 NOT MET
Verify the process the PACE organization has in place to ensure

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA
participant access to care 24 hours a day, 7 days a week.

CRITERIA MET

 MET
 NOT MET

Verify that the PACE organization’s network will include all required
services (through staff or contract) by the time the PACE Center
becomes operational.

 MET
 NOT MET

Evidence of a health information system to collect, analyze, and report
participant data.

 Other (Specify
and Attach)

OTHER (SPECIFY)
General Safety
Requirements
IX.
Overall PACE Center
safety requirements

Evidence of state pharmacy licensure.

Written policies and procedures for narcotic inventory control and
disposal.

All Medications are locked in a cabinet, room or cart.

 MET
 NOT MET
 N.A.
 MET
 NOT MET
 MET
 NOT MET

NOTES

OMB Control Number: 0938-1326
Expires: TBD

PACE
REGULATION
REQUIREMENT

READINESS CRITERIA

Written policies and procedures for refrigerator temperature logs used
for medication and food storage.

Written policies and procedures for oxygen storage that is in
compliance with fire safety and FDA laws.

Evidence of CLIA certification if the PACE Center is performing
waived lab services on site or in the home, e.g. glucose meter testing,
urine testing, fecal occult testing, blood testing, cholesterol screening,
or hemoglobin or hematocrit testing.

OTHER (SPECIFY)

CRITERIA MET

 MET
 NOT MET

 MET
 NOT MET
 MET
 NOT MET

 Other
(Specify and
Attach)

NOTES

File Type	application/pdf
File Title	PART 1 GENERAL INFORMATION
Author	Emmanuelle Goodrich
File Modified	2018-02-16
File Created	2018-01-23