100-11 Programs of All-Inclusive Care for the Elderly (PACE)Manual: Chapter 9 - Organization's Relationship with Health Care Providers

Programs of All-Inclusive Care for the
Elderly (PACE)
Chapter 9 – Organization’s Relationship with Health
Care Providers
Table of Contents
(Rev. 2, Issued: 06-09-11)
Transmittals for Chapter 9
10 - Employed Direct Care Providers
10.1 - Requirements for Employment
10.2 - Staff and Contractor Competencies
10.3 - Competency Assessment
20 - Requirements for Employees and Contracted Staff
20.1 - Orientation and Training
20.2 - Orientation
20.3 - Personal Care Aide (PCA) Training
20.4 - All Personnel: Direct Participant Care Training
20.5 - Immunization and Physical Health
30 - Contract Providers
30.1 - Requirements for Written Contracts and Contract Requirements
30.2 - Requirements of Contract Providers and Vendors
30.3 - Requirements of Institutional Contractors, and Practitioners or Suppliers
40 - Special Rules for Emergency Care
50 - Contracting with another Entity to Furnish PACE Center Services
60 - Documenting Contractor Compliance

10 - Employed Direct Care Providers
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
10.1 - Requirements for Employment
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Each member of the PACE organization’s staff who has direct participant contact
(employee or contractor) must:
• 	Have a minimum of one year of experience working with the frail or elderly
population including the Primary Care Physician (PCP);
• 	Be medically cleared of all communicable diseases and have all
immunizations up-to-date before engaging in direct participant care;
• 	Be legally authorized (licensed, certified or registered) to practice in the State
in which they practice if the State has established requirements or they must
meet the State requirements that authorize them to practice in their State; and
• 	Only act within the scope of his or her authority to practice;
• 	Meet standardized competencies for the specific position description
established by the PACE organization and approved by CMS before working
independently (only applies to home care aides);
• 	A social worker must have a master’s degree in social work from an
accredited school of social work.
The PACE organization must ensure that these requirements are met and, as discussed in
section 10.2, have policies and procedures regarding these requirements.
In order to maintain compliance with program integrity the PACE organization must:
• 	Not employ individuals excluded from participation in the Medicare or
Medicaid programs;
• 	Not employ individuals convicted of Medicare, Medicaid, or other health
insurance, health care, or any social service program-related crimes;
• 	Not employ individuals convicted of physical, sexual, drug, or alcohol abuse
in any capacity where such individual’s contact with participants would pose a
potential risk.
[42 CFR §§ 460.64(a); 460.68(a)]

10.2 - Staff and Contractor Competencies
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In order to comply with PACE requirements, it is required that the PACE organizations
have a policy and procedure in place for assuring that staff and contractors:
• 	Are legally authorized (licensed, certified, registered) to practice in the State
in which they provide services;
• 	Meet State requirements that authorize them to provide services; and,
• 	They only act within the scope of his or her authority to practice.
The policy and procedures would also demonstrate that the PACE organization has a
system for updating staff competency information, and discloses, upon request,
information regarding:
• 	Board certification and other credentialing requirements;
• 	Clinical protocols;
• 	Medical practice guidelines, consumer satisfaction survey results; or
• 	The results of the organization’s most recent Federal or State review.
PACE organizations may wish to refer to credentialing guidance in the Medicare
Managed Care Manual for a description of one option on which to build the policy and
procedure:
(http://www.cms.gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=-
99&sortByDID=1&sortOrder=ascending&itemID=CMS019326&intNumPerPage=10).
[42 CFR § 460.64]
10.3 - Competency Assessment
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must develop a competency evaluation program to ensure all
employees and contracted staff providing direct care to participants can demonstrate the
skills, knowledge and abilities necessary for performance of their position. The PACE
organization must designate a staff member to oversee these activities for employees and
work with the PACE contractor liaison to ensure compliance by contracted staff. The
competency evaluation program must be completed by each employee prior to providing
direct participant care. An employee demonstrating competence for their position is
essential to ensure the delivery of safe care.

All personnel, including personal care attendants, need to meet the credentialing criteria
and a standardized set of competencies for their specific position prior to their engaging
in direct participant care. The PACE organization’s competency evaluation program
must:
• 	Describe the minimum skills necessary to perform each specific job;
• 	Describe the process for initially testing competency;
• 	Identify the individual(s) responsible for competency testing for employees;
• 	Identify the individual designated to work with the PACE contractor liaison to
ensure compliance by contracted staff;
• 	Explain how the PACE organization will resolve competency deficiencies.
The PACE organization must conduct an annual competency review with their
employees, including personal care attendants. The PACE organization’s annual
competency review program will:
• 	Describe the periodic competency review program;
• 	Identify who is responsible for periodic competency review;
• 	Explain how the PACE organization will resolve competency deficiencies.
[460 CFR § 460.66(a) and (c); 460.71(a)]
20 - Requirements for Employees and Contracted Staff
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
20.1 - Orientation and Training
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization is required to provide training to maintain and improve the skills
and knowledge of each staff member with respect to the individual’s specific duties that
result in his or her continued ability to demonstrate the skills necessary for the
performance of the position.
The PACE organization must ensure that all employees and contracted staff furnishing
care directly to participants demonstrate the skills necessary for performance of their
position. The PACE organization must provide each employee and all contracted staff
with an orientation. The orientation must include, at a minimum, 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.

The PACE organization must develop a training program that will:
• 	Identify the person and position responsible for the overall training program;
• 	Describe the content of the training program including initial orientation and
periodic refresher training including PACE-specific topics and position-
specific topics;
• 	Describe the instructors, methods of teaching, methods of testing, and results
of any testing (written or oral); and
• 	Discuss how the PACE organization will resolve knowledge deficits.
[42 CFR §§ 460.66(a), 460.71(a)(1)]
20.2 - Orientation
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must provide a comprehensive orientation program to each
employee and all contracted staff. Documentation of completion date(s) for each and
every component of the orientation must be maintained in staff records. This orientation
must be provided prior to personnel engaging in direct participant care. The orientation
must include, at a minimum, 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. Additionally, the orientation may include, but isn’t limited
to:
• 	Role of the team;
• 	Organizational Chart: who everyone is on the team and at the center;
• 	Standards of care and conduct;
• 	QI program: overview, principles, the staff role;
• 	List of providers;
• 	OSHA, standard precautions, infection reporting, waste management;
• 	Participant safety;
• 	Care of the elderly;
• 	Training on medical equipment used in the PACE organization;

• 	Body mechanics;
• 	Personnel policies;
• 	Medical documentation requirements.
[42 CFR § 460.71(a)]
20.3 - Personal Care Aide (PCA) Training
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In addition to the general training program, the PACE organization must develop a
training program for each directly employed and contracted PCA in order to establish the
individual’s baseline competency in furnishing personal care services and specialized
skills associated with the specific care needs of individual participants. The training plan
must indicate how each skill is tested to determine the PCA’s initial and ongoing
competency. The PACE organization must evaluate the skills of each newly hired PCA
and develop a training program specific to the competencies or deficiencies that they
demonstrate. PCAs must exhibit competency before performing personal care services
independently. A process must be in place for monitoring ongoing competency
assessments and identify the individual responsible for supervising PCAs. This training
must be performed by qualified professionals. The personnel file must contain the results
of any testing, both written and oral.
[42 CFR § 460.66(b) and (c)]
20.4 - All Personnel: Direct Participant Care Training
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must provide ongoing training to maintain and improve the skills
and knowledge of each employee and contracted staff member with respect to their
specific duties in order to ensure that PACE participants receive the highest quality care
possible. A PACE organization has the ultimate responsibility for all care provided to
their participants and, therefore, it is in the best interest of PACE participants and the
PACE organization that they provide training specific to their participant population.
Ongoing in-service training for all staff will ensure that skills remain current and any
detrimental practices are caught and rectified as early as possible.
Annual training must be related to specific positions which include relevant topics.
Training needs to be staggered throughout the year to enable all staff to participate. The
training program needs to describe plans for in-service training, the methods of teaching
including handouts, pre and post test, if applicable, and the person/position conducting
the training. Some PACE organizations may have the ability to use the health care facility
to which they are related or they may use an outside agency for training purposes.

OSHA training must be provided on hire and is required annually, [29 CFR
1910.1030(g)(2)] by a qualified trainer. The employee cannot be given just a manual,
pamphlet or policy to read. This training must be given in an interactive session with a
trainer present.
[42 CFR §§ 460.66(a); 460.71]
20.5 - Immunization and Physical Health
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE regulation stipulates that the PACE organization must develop and implement
an infection control plan having specific procedures to prevent, identify, investigate, and
control infections. Specifically, this regulation mandates compliance with the standard
precautions developed by the Center for Disease Control and Prevention (CDC). A
primary standard precaution in caring for the frail elderly population is immunization of
healthcare workers. The CDC strongly recommends that healthcare workers be
immunized against hepatitis B virus, influenza, measles, mumps, rubella, and varicella to
protect them from acquiring or transmitting these vaccine-preventable infections.
The PACE organization must also include procedures in its infection control plan to
prevent healthcare workers from acquiring or transmitting tuberculosis and bloodborne
pathogens. In the exposure control section of the infection control plan, the PACE
organization must identify the specific job classifications that perform duties in which
exposure to active tuberculosis disease or bloodborne pathogens occurs. In a typical
PACE organization, most, if not all, healthcare workers deliver direct care services to
participants and should be classified as at-risk for exposure to these pathogens.
Pursuant to CDC recommendations, CMS issued regulation 42 CFR § 460.64(a)(5) which
states that staff having direct participant contact must be “medically cleared for
communicable diseases and have all immunizations up to date before engaging in direct
participant contact.” To meet this regulatory requirement, CMS expects the PACE
organization to minimally take the following actions:
• 	Develop and implement policies and procedures to assure medical clearance
during the pre-employment period. Medical clearance refers to appropriate
management of:
• 	Respiratory infections - appropriate precautions such as wearing face
masks or other personal protective equipment (PPE) or delaying the start
date for providing direct care when prospective employees present with
respiratory infections (common colds, pneumonia, etc.) which are
transmittable through close contact;
• 	Skin infections – appropriate precautions such as requiring the covering of
open and seeping lesions or delaying the start date for providing direct
care when prospective employees present with skin infections (methicillin-

resistant Staphylococcus aureus (MRSA), varicella zoster (shingles),
pediculosis (lice infestation), etc.) which are transmittable through close
contact;
• 	Gastrointestinal infections – appropriate precautions such as delaying the
start date for providing direct care when prospective employees present
with gastrointestinal (GI) symptoms (vomiting or diarrhea related to acute
viral hepatitis, food-borne bacterial infections, etc.) which are
transmittable through close contact;
• 	The PACE organization must determine the methodology (medical history
tool, interview by clinician, etc.) by which it will assure that participants and
other healthcare workers at the facility have protection in the workplace from
exposure to infectious diseases. The State Administering Agency and
jurisdictional public health agency may be important resources in developing
these policies and procedures;
Develop and implement policies and procedures to assure appropriate healthcare worker
immunization.
Additional information on CDC recommendations for immunizations of staff can be
found at the following links:
Centers for Disease Control and Prevention, Immunization of Health-Care Workers:
recommendations of the Advisory Committee on Immunization Practices (ACIP) and the
Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR
1997;46(No. RR-18): http://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4618.pdf.
Centers for Disease Control and Prevention, Protecting Health Care
Workers: http://www.cdc.gov/ncidod/dhqp/worker.html.
Centers for Disease Control and Prevention, Influenza Vaccination of Health-Care
Personnel: recommendations of the Healthcare Infection Control Practices Advisory
Committee (HICPAC) and the Advisory Committee on Immunization Practices
(ACIP): http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5502a1.htm.
Centers for Disease Control and Prevention, Guidelines for Preventing the Transmission
of Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR 2005;54(No. RR-
17): http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.
30 - Contract Providers
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must develop a policy and procedure that provides for formal
oversight activities such as periodic observation of service delivery, review of service

documentation, assurance of participation in refresher training, and review of applicable
credentials.
[42 CFR § 460.71]
30.1 - Requirements for Written Contracts and Contract Requirements
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must have a written contract with each outside organization,
agency, or individual that furnishes administrative or care-related services not furnished
directly by the PACE organization except for emergency services. A current list of
contractors must be on file at the PACE center and a copy must be provided to anyone
upon request.
Each contract needs to be in writing and contain the following information:
• 	Name of contractor;
• 	Services furnished (including work schedule if appropriate);
• 	Payment rate and method; and
• 	Terms of the contract, including the beginning and ending dates, as well as
methods of extension, renegotiation, and termination.
A contract between a PACE organization and a contractor must meet the following
requirements:
(1) The PACE organization must contract only with an entity that meets all applicable
Federal and State requirements, including, but not limited to, the following:
• 	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 it furnishes;
• 	A contractor must comply with the requirements of this part with respect to
service delivery, participant rights, and quality assessment and performance
improvement activities;
(2) A contractor must be accessible to participants, located either within or near the
PACE organization’s service area; and
(3) A PACE organization must designate an official liaison to coordinate activities
between contractors and the organization.

[42 CFR §§ 460.70(a), (b), (c), and (d)(1) through (4)]
30.2 - Requirements of Contract Providers and Vendors
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In addition to the contract requirements in section 30.1 above, a contractor agreement
must include the following written requirements for the contractor to adhere to:
• 	Furnish only those services authorized by the PACE IDT;
• 	Accept payment from the PACE organization as payment in full and not bill
participants, CMS, the State Medicaid agency or private insurers;
• 	Hold harmless CMS, the State and PACE participants if the PACE
organization cannot or will not pay for services performed by the contractor
under the contract;
• 	Not assign the contract or delegate duties under the contract unless prior
written approval is obtained from the PACE organization;
• 	Submit reports as required by the PACE organization;
• 	Agree to perform all the duties related to its position as specified in Part 460;
• 	Participate in IDT meetings as required;
• 	Agree to be accountable to the PACE organization; and
• 	Comply with the competency evaluation program and direct participant care
requirements specified in 42 CFR § 460.71.
[42 CFR § 460.70(d)(5)]
30.3 - Requirements of Institutional Contractors, and Practitioners or
Suppliers
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Institutional providers include, but are not limited to:
• 	Acute care hospitals;
• 	Rehabilitation hospitals and distinct part rehabilitation units of acute care
hospitals;

• 	Psychiatric hospitals and distinct part psychiatric units of acute care hospitals;
and
• 	Critical access hospitals, nursing facilities and skilled nursing facilities.
The PACE organization must contract only with institutional entities that meet all
applicable Federal and State requirements as well as meet the Medicare and Medicaid
participation requirements. There is provider specific Conditions of Participation for
institutions that participate in the Medicare program. Therefore, all institutional
contractors must be in compliance with their respective Conditions of Participation.
A practitioner or supplier must meet Medicare or Medicaid requirements applicable to the
services it furnishes.
[42 CFR § 460.70]
40 - Special Rules for Emergency Care
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Authorization is required for services a participant may need while temporarily absent
from the PACE organization’s service area that are not emergency services but cannot be
delayed until the participant returns.
A PACE organization must establish a written plan for handling emergency health care
needs. The plan must include that the participants and their caregiver know:
• 	When and how to access emergency services;
• 	That no prior approval is necessary for emergency services;
• 	That CMS, the State and PACE participants are held harmless for emergency
services;
• 	That the PACE organization must provide for availability of on-call providers
to address any participant questions about accessing emergency services and
respond to requests for authorization of urgently needed out-of network
services or post-stabilization.
Listed below are the types of services that fall under this special rule category:
• 	Emergency care is appropriate when services are needed immediately because
of an injury or sudden illness and the time required to reach the PACE
organization or a network provider would cause the risk of permanent damage
to the participant’s health. Thus, emergency care services include inpatient
and outpatient services, furnished by a qualified emergency services provider
(other than the PACE organization or one of its contract providers) either in or

out of the PACE organization’s service area and that are needed to evaluate or
stabilize an emergency medical condition. Emergency services that fall within
this description do not require authorization by the PACE organization.
Determination of the need for emergency care is dependent on the prudent
layperson standard with average knowledge of health and medicine;
• 	Urgent care means the care provided to a PACE participant who is out of the
PACE services area, and who believes their illness or injury is too severe to
postpone treatment until they return to the service area, but their life or
functioning is not in severe jeopardy. Participants are expected to seek prior
approval from the PACE organization in order for urgent care services to be
covered by the PACE organization;
• 	Post-stabilization care means services provided subsequent to an emergency
that a treating physician views as medically necessary after an emergency
medical condition has been stabilized. They are not emergency services,
which PACE organizations are obligated to cover. Rather, they are non-
emergency services that the PACE organization should approve before they
are provided outside of the service area. Prior approval of these services is
intended to ensure efficient and timely coordination of appropriate post
emergency care by the IDT. In order to ensure that unforeseen circumstances
do not result in delays in needed care, CMS clarified that the PACE
organization must cover urgently needed out-of-network or post-stabilization
care services if it does not respond to a request for approval within one hour
after being contacted or cannot be contacted for approval.
[42 CFR § 460.100(b), (c), (d) and (e); 71 FR 71284 (Dec. 8, 2006)]
50 - Contracting with another Entity to Furnish PACE Center Services
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must meet certain criteria to contract out PACE center services.
The following criteria must be included:
• 	Any subcontracting arrangements by the PACE center would need to be
approved in writing by the PACE organization;
• 	The PACE organization must be fiscally sound as defined in 42 CFR §
460.80(a) and have demonstrated competence with the PACE model as
evidenced by successful CMS and State onsite reviews and monitoring efforts.
The PACE organization retains responsibility for all participants and may only contract
for the PACE center services identified in 42 CFR § 460.98(d) as described in detail
in Chapter 6, which include: primary care, social services, restorative therapies, personal
care and supportive services, nutritional counseling, recreational therapy, and meals.

[42 CFR § 460.70(e)]
60 - Documenting Contractor Compliance
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The burden of documenting contractors’ compliance with applicable standards ultimately
rests with the PACE organization.
It is especially important to identify specific responsibilities of a contractor. The PACE
organization must develop its own procedures to ensure that the entity complies with the
standards of competency and quality of care.
The PACE organization must not contract with organizations or individuals who have
been excluded from the Medicare or Medicaid programs; who have been convicted of
criminal offenses related to their involvement in Medicaid, Medicare, other health
insurance or health care programs, or social service programs under Title XX of the Act;
or for those having participant contact, who would pose a potential risk because of prior
physical, sexual, drug, or alcohol abuse conviction.
The PACE organization must contract with only those entities that meet all applicable
Federal and State requirements.
All employees and contractors must meet the personnel qualifications for the physician,
registered nurse, social worker, physical therapist, occupational therapist, recreational
therapist, dietitian and driver.
Although the PACE organization is not performing the actual compliance checks (in the
case of a hospital, physician, medical equipment, or supplies), the organization must
ensure that the contractor is in compliance with the written contract. The written contract
must state that the contractor will meet all applicable Federal and State requirements
allowing the PACE organization some flexibility in determining the organizational
process that will occur to ensure their contractors meet all program requirements.
In the case of an independent contractor or provider-based organization who provides
direct participant care and has not been credentialed through a Medicare or Medicaid
contracting organization, the PACE organization will have to receive the same documents
from the contractor as they would for an employee. If the contractor is working for the
contracted organization and not independently, then the contracted organization must
forward all of their staff credentials prior to performing participant care.
The PACE organization is responsible for not only ensuring the contract staff meet
requirements at the onset of the contract, but on an ongoing basis. The contract
organization has to have a process in place to ensure this compliance and the PACE
organization has to have a process to review contract compliance. The contract
organization must have a process in place to notify the PACE organization when one of
their staff is out of compliance so that the PACE organization does not utilize that staff

member for participant care (in the case of a license expiring, other sanctions, or illegal
activity).
[42 CFR §§ 460.64; 460.68(a); 460.70(b)(1)]

Transmittals Issued for this Chapter
Rev # 	Issue Date 	Subject 	Impl Date CR#
R2PACE 06/09/2011 	Initial Publication of Manual 	06/03/2011 NA
R1_SO 06/03/2011 	Initial Publication of Manual - Rescinded and
replaced by Transmittal 2
06/03/2011 NA
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