CMS Pub. 100-11, ch. 10, § 20.2

Through the QAPI program, PACE organizations should evaluate the effectiveness of the

wide range of services furnished by PACE organizations and use data to identify,

improve and maintain program performance. CMS believes that each PACE organization

should have the flexibility to design an internal QAPI that would best meet the needs of

its enrolled participants and their caregivers; therefore, CMS neither specified a

standardized quality assessment tool nor dictated the data-driven outcome measures that

PACE organizations should internally collect, analyze, and act on to improve

performance. However, CMS did provide in 42 CFR § 460.132 (and discussed in

section 20.1) the minimum requirements that must be addressed in the PACE

organization’s written plan for the internal QAPI program, including the requirement that

the plan be reviewed annually and revised by the respective PACE governing body to

assure organizational oversight and commitment.

A PACE organization’s QAPI program must include, but not be limited to, the use of

objective measures to demonstrate improved performance with regard to five areas: 1)

utilization of services (e.g., decreased inpatient hospitalizations and emergency room

visits), 2) participant and caregiver satisfaction, 3) outcome measures that are derived

from data collected during participant assessments, 4) effectiveness and safety of staff-provided and contracted services, and 5) non-clinical areas including grievances and

appeals.

• Utilization of Services. Collected utilization data such as hospitalizations and

emergency room visits can be used to evaluate fiscal well-being, as well as

evaluate quality of care. It can also be used to target reviews of PACE centers

whose utilization data suggest, for example, that participants may be receiving

fewer services than necessary to achieve expected outcomes. The purpose for

including utilization data in the PACE organization’s QAPI program is to help

the PACE organization ensure that participants receive the appropriate level of

care through their PACE center. Additionally, by collecting and analyzing

information regarding utilization of and reasons for emergency care and

hospital and nursing home admissions, the PACE organization can identify

areas for improvement;

• Participant and Caregiver Satisfaction. Participant and caregiver

satisfaction with services is an important element of a QAPI program. A

PACE organization must survey, on an ongoing basis, participants and their

caregivers to determine satisfaction with the services furnished and the

outcomes achieved. Given the large number of PACE participants who are

cognitively impaired and the critical role caregivers play in keeping PACE

participants in the community, it is important to survey caregivers about their

satisfaction with the program. CMS expects the PACE organization to use this

information to identify opportunities to improve services and caregiver and

participant satisfaction. Although CMS does not require the use of a specific

survey tool in measuring participant and family satisfaction, the PACE

organization is expected to demonstrate a scientifically sound satisfaction

measurement system and how it is used as part of the overall internal QAPI

system;

• Data Collected During Participant Assessments. Outcome measures are

derived from participant assessment data to determine if individual and

organization-level measurable outcomes are achieved within a specified time

period. The compiled data must include, at a minimum, the physiological

well-being, functional, mental health, social and behavioral status, cognitive

ability, and quality of life of the participant assessment information;

For example, PACE organizations are expected to focus their quality

improvement activities on outcomes such as stabilization in ability to bathe,

from a baseline period to each follow-up period; improvement in dyspnea

from admission into PACE to a follow-up period; improvement in

transportation services over a specific period of time; and improvement in

caregiver stress from participant admission into PACE to a follow-up period

(42 CFR § 460 Preamble Discussion/Federal Register December 2006);

• Effectiveness and Safety of Direct and Contracted Services Delivered to

Participants. The effectiveness and safety of the PACE services provided by

the PACE organization’s staff or contracted services must be evaluated, to

include competency of clinical staff, promptness of service delivery, and

achievement of treatment goals and measurable outcomes.

For participants to experience the outcomes that the PACE benefit is intended

to achieve, staff must demonstrate skills and competencies necessary to

facilitate those desired outcomes. The PACE organization is expected to

include data-based, criterion-referenced performance measures of staff skills,

to utilize these data to ensure that staff maintains skills and to provide training

as new techniques and technologies are introduced and as new staff are hired.

Each PACE organization will be expected to demonstrate that it has a system

of appropriate complexity for keeping track of the skills and competencies of

the staff and for effectively identifying and addressing staff training needs.

These data should be an integral part of the PACE organization’s internal

QAPI program that provides continuous feedback on staff performance;

• Non-Clinical Areas. The types of outcomes in this area include outcomes

related to grievances and appeals, transportation services, meals, life safety,

and environmental issues.

For example, if a PACE organization finds a high rate of grievances not resolved, the

PACE organization might target its activities to improve the grievance process.

Furthermore, CMS requires that the PACE organizations ensure the accuracy, integrity,

and completeness of all data used for outcome monitoring. A data-driven QAPI program

must be based on accurate data. The regulations require that PACE organizations set up

mechanisms to check for the accuracy, timely collection, and completeness of all data. As

such, CMS would expect to see a formal data integrity training program and competency

evaluation for all staff responsible for collecting or analyzing data.

[42 CFR §§ 460.130; 460.132(c)(2); 460.134(a) and (d); 71 FR 71304 through 71306

(Dec. 8, 2006)]