CMS Pub. 100-11, ch. 10
(Rev. 2, Issued: 06-09-11)
10 - Introduction
20 - QAPI Program
20.1 - QAPI Plan
20.2 - QAPI Requirements
20.3 - Internal QAPI Activities
20.4 - QAPI Committee
30 - Additional Quality Assessment Activities
30.1 - External Reporting Requirements
30.2 - Level One Reporting Requirements
30.3 - Level Two Reporting and Reporting Thresholds
30.4 - Reporting Requirements of Level Two Incidents
30.5 - Process for Conducting Root Cause Analysis
30.6 - Format for Level Two PACE Organization Conference Call Case Presentation
30.7 - Health Outcomes Survey – Modified (HOS-M)
30.8 - Medicare HOS-M Sampling
30.9 - HOS-M Instrument
30.10 - Dissemination of HOS-M Results to Plans
30.11 - HOS-M Program or Policy Questions
30.12 - Additional Required Reporting
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Title 42 CFR § 460, Subpart H – Quality Assessment and Performance Improvement (QAPI), establishes the quality improvement program requirements that the Programs of All-Inclusive Care for the Elderly (PACE) organizations must meet under the Social Security Act. Furthermore, Sections 1894(e)(3)(B) and 1934(e)(3)(B) of the Act require that, under a PACE Program Agreement, the PACE organization, CMS, and the State Administering Agency shall jointly cooperate in the development and implementation of health status and quality of life outcome measures with respect to PACE participants.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PACE organization must develop, implement, maintain, and evaluate an effective data-driven QAPI program. It is important that the QAPI program reflects the full range of services furnished by the PACE organization. In developing the QAPI program, the PACE organization should use organizational data to identify and improve areas of poor performance. The PACE organization must take actions that result in improvements in its performance in all types of care.
Currently, CMS does not require the use of a common quality assessment tool or a set of specific outcome measures beyond the data elements for monitoring included in the program agreement. PACE organizations have the flexibility to develop the QAPI program that best meets their needs in order that they may fully meet the obligations of care for its participants. It is CMS’s expectation that PACE organizations will operate a continuous QAPI program that does not limit activity to only selected kinds of services or types of patients. The desired outcome of the QAPI requirement is that data-driven quality assessment serves as the engine that drives and prioritizes continuous improvements for all the PACE organization’s services.
[42 CFR §§ 460 Preamble Discussion, 460.130; 71 FR 71305 (Dec. 8, 2006)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The PO must have a written QAPI plan. 42 CFR § 460.132(b) requires POs to have their QAPI plan reviewed annually by the PACE governing body and, if necessary, revised.
At a minimum, the PACE organization’s QAPI plan must 1) identify areas in which to improve or maintain the delivery of services and patient care; 2) develop and implement plans of action to improve or maintain quality of care; and 3) document and disseminate the results of the QAPI activities to the PACE staff and contractors.
As per 42 CFR § 460.132(a)(b), the PACE organization leadership presents their QAPI plan and any revisions to their governing body for annual approval to assure effective
organizational oversight. CMS and the State Administering Agency approve the QAPI plan prior to its inclusion in the program agreement and also review the plan during subsequent monitoring visits.
[42 CFR § 460.132]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
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.
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;
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);
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;
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)]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
PACE organizations must use a set of outcome measures to identify areas of good or problematic performance and take actions targeted at maintaining or improving care based on these outcome measures. CMS expects PACE organizations to use the most current clinical practice guidelines and professional standards in the development of outcome measures applicable to the care of PACE participants. Continuous improvement is only possible through identification and use of current information, techniques, and practices. CMS also expects the PACE organization will utilize the current clinical and professional standards as a routine part of its daily operations. A PACE organization must ensure that all IDT members, 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 such, the PACE organization must:
Prioritize performance improvement activities based on prevalence and severity of identified problems, and give priority to activities that improve clinical outcomes;
Immediately correct an identified problem that directly or potentially threatens the health or safety of participants;
Furthermore, the PACE organization must meet minimum levels of performance on standardized quality measures which are specified in the PACE Program Agreement. Currently, CMS requires all PACE organizations to achieve at least an 80 percent flu immunization rate for their PACE participants. If a PO fails substantially to meet these specified requirements, the continuation of the PACE program agreement may be conditional on the execution of a CAP, or alternatively, some or all further payments for PACE program services may be withheld until the deficiencies have been corrected.
By virtue of being a full-service program targeting the vulnerable frail elderly, PACE leaders face unique challenges. An effective QAPI program requires continuous surveillance by all stakeholders (employed and contracted staff, caregivers, and participants) of the range of PACE services. CMS believes the designation of a dedicated QAPI coordinator is imperative to conduct continuous performance improvement activities that inform the PACE organization leadership ultimately responsible for care delivery including, but not limited to: ambulatory, home health, adult daycare, long-term, acute, emergency, and restorative services. Within these domains of care, leaders oversee multiple disciplines internally such as medical, nursing, social, mental health, recreation therapy, dietary, restorative therapies, transportation, as well as specialized services in the community.
CMS requires the PACE organization to identify the Medical Director as the person and position responsible for the oversight of the QAPI program. Furthermore, the medical director has oversight responsibility for patient outcomes, assures data completeness, plan development, performance of activities, and outcome evaluations for plan effectiveness.
A PACE organization must designate an individual to be the QAPI coordinator, whose function is to coordinate and oversee the implementation of quality assessment and performance improvement activities. The QAPI coordinator would be responsible for day-to-day quality issues, collecting data, analyzing data, detecting trends, coordinating IDT members, PACE staff, and contract providers in planning QAPI activities, disseminating reports on activities to them, and compiling comments related to participant/caregiver satisfaction and concerns. The QAPI coordinator must encourage PACE participants and his or her caregivers to be involved in QAPI activities, including providing information about their satisfaction with services.
[42 CFR §§ 460.134, 460.136, 460.202(a); Level Two Guidance, October 2010]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
A PACE organization is required to develop a committee(s) with community input to 1) evaluate data collected pertaining to quality outcome measures, 2) address the implementation of and results from the QAPI plan, and 3) provide input related to ethical decision-making including end-of-life issues and implementation of the Patient Self-Determination Act. Through this committee(s), the PACE organization will be able to receive guidance regarding its QAPI program and the ethical issues faced by PACE organizations.
[42 CFR § 460.138]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
An essential component of an effective quality improvement program is risk assessment and management. Risk management entails identifying and systematically reducing potential risks to the safety of PACE participants and the healthcare environment. Risk assessment ideally is conducted prospectively to prevent occurrences that result in adverse health outcomes to participants or staff, or harm to the organization's physical plant/equipment or fiscal status. In reality, risk assessment is most often conducted in response to an event that results in medical, psychosocial, cognitive, or functional harm to a participant or staff. Every person employed or contracted by the PACE organization has responsibility for risk assessment and management.
External monitoring activities refer to both:
This manual and the PACE Level Two External Reporting Guidance (the "Level Two Guidance") clarify the Level Two reporting events that must be expeditiously reported to CMS.
[42 CFR § 460.140; Level Two Guidance, October 2010]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
This manual and the Level Two Guidance provide an overview of requirements for PACE organizations to report both aggregate and individual-level data to CMS and State Administering Agencies for their use in monitoring PACE organizations' performance.
PACE requirements include Level One and Level Two Reporting, Health Outcomes Survey-Modified (HOS-M) participation and additional reporting to other Federal and State health authorities as required.
The Level Two Guidance replaces the Sentinel Events Reporting Policy issued by CMS in 2004. In so doing, CMS is discontinuing use of the term "sentinel event" and adopting an external reporting paradigm that distinguishes between Level One and Level Two Reporting Requirements as described below.
[42 CFR §§ 460.140; 460.202(b); Level Two Guidance, October 2010]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Level One Reporting Requirements refers to those data elements for monitoring that are regularly reported by PACE organizations via the Health Plan Management System (HPMS) PACE monitoring module. These monitoring elements are detailed in the HPMS PACE User's Guide, Fall 2005
(https://www.cms.gov/PACE/Downloads/hpmsmanual.pdf) and include:
The HPMS database is regularly monitored by staff in the CMS Regional Office (RO) and State Administering Agency (SAA).
Data reported in response to the Level One Reporting Requirement are used by PACE organizations to identify opportunities for quality improvement. For example, based on their review of Level One data reported in HPMS, PACE organization's may:
[HPMS PACE User's Guide, Fall 2005; Level Two Guidance, October 2010]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
When unusual incidents meet specified reporting thresholds, PACE organizations are required to report them on a timely basis as Level Two Reporting Incidents to CMS Central Office and Regional Offices and the State Administering Agency. Level Two incidents require internal investigation and analysis of the occurrence by the PACE organization with the goal of identifying system(s) failures and improvement opportunities.
For example, Level Two reportable incidents may include:
Infectious Disease Outbreak that meet the threshold of three or more cases (or the respective State standard if more stringent) linked to the same infectious agent within the same time frame;
Pressure Ulcer acquired while enrolled in the PACE program;
For a specific listing of reportable incidents and thresholds, refer to the Level Two External Reporting Guidance, October 2010.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
When an incident meets a Level Two reporting threshold, the PACE organization must complete the following steps:
Within 48 hours of determining the threshold for Level Two reporting has been met, notify CMS via e-mail at the dedicated PACE mailbox PACE@cms.hhs.gov and copy the State Administering Agency and the Regional Office.
Email notification must provide:
If the PACE organization is unsure if a Level Two reporting threshold has been met, the PACE organization will consult with its CMS Regional Office Account Manager by
telephone. The PACE organization's contact with the CMS Regional Office Account Manager must be made within 24 hours (or next business day) of determination that Level Two reporting may be required.
The PACE organization must undertake an internal investigation of the incident. The investigation must be initiated within 24 hours of reporting the incident to CMS and the State Administering Agency, and must be concluded within 30 days of reporting the incident. If the internal investigation cannot be completed within 30 days, then prior to the 30-day deadline, the organization must notify CMS by sending an email to PACE@cms.hhs.gov with a copy to the State Administering Agency and the CMS Regional Office. The notification must describe the circumstances preventing completion of the investigation within the 30-day time period and provide information on when the investigation will be completed.
In general, it is expected that the PACE organization's investigation will include a root cause analysis as described below. There are instances, however, when PACE organization staff may feel that a root cause analysis will not yield programmatic improvement information. If this is the case, the PACE organization is to consult promptly, by telephone, with its CMS Regional Office Account Manager.
It is important to document all participant-specific events in the PACE medical record, particularly if they result in injury or require a treatment or a change in the care plan. Documentation should include a statement of the event, an assessment, a diagnosis (if appropriate), any follow up plans and participant progress. However, any specific details that relate to the investigation of the event (e.g., what were the contributing factors, was care inconsistent with policy, any concerns of quality of care, etc.) do not need to be included in the medical record. All such documentation should be kept separately in a Quality Assurance file.
Notify CMS via PACE@cms.hhs.gov with a copy to the State Administering Agency and CMS Regional Office when the internal investigation is completed. CMS will schedule a conference call within 30 days of this notification to discuss the organization's internal investigation, subject to the availability of key individuals from all entities. Any additional follow-up required subsequent to the call will be coordinated by the PACE organization, CMS RO and the SAA.
[Level Two Guidance, October 2010; http://www.cms.gov/pace/]
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
A root cause analysis must be completed for events for which the PACE organization's staff, or PACE organization staff in consultation with the CMS Regional Office, determines the identified event is sufficiently serious that an in-depth understanding of how it could occur is essential, and/or multiple fail-safe measures are required as part of the organization's improvement plan. As described above, PACE organizations are to
consult with their CMS Regional Office Account Manager in cases where the PACE organization believes a root cause analysis is not necessary.
There are many print and web-based resources to guide PACE personnel in conducting a root cause analysis. Several essential elements are outlined below:
o Define the period during which progress will be monitored for improvement;
• Evaluate the effectiveness of corrective action:
o Assess the improvement in performance;
o Revise the action plan accordingly.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
When the PACE organization has completed its internal investigation of the incident meeting the threshold for Level Two Reporting, the PACE organization must notify CMS via PACE@cms.hhs.gov with a copy to the State Administering Agency and CMS Regional Office. The PACE organization must prepare a case presentation for discussion on the call. When preparing the case presentation, the PACE organization will include the following information in its discussion:
Working relationship with contracted facility, contracted services (if applicable);
Compliance with organization's established policies and procedures;
For a specific listing of reportable incidents and case scenarios, refer to CMS, PACE Level Two External Reporting Guidance, October, 2010 (effective 01/04/2011).
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The Medicare Health Outcomes Survey-Modified (HOS-M) was fielded for the first time in the spring of 2005. Originally entitled the Programs of All-Inclusive Care for the Elderly (PACE) Health Survey, the HOS-M is administered to vulnerable Medicare beneficiaries at greatest risk for poor health outcomes. All PACE organizations that are operational on or before January 1 of the preceding year are required by CMS to administer the HOS-M during the current reporting year (e.g., January 1, 2009 for the 2010 HOS-M administration).
The HOS-M is a modified version of the Medicare HOS that is administered by CMS. Similar to the HOS, the HOS-M design is based on a randomly selected sample of individuals from each participating PACE organization. The HOS-M is a cross-sectional survey, measuring the physical and mental health functioning of beneficiaries at a single point in time. This differs from the HOS, which has a follow-up component.
One of the main goals of the HOS-M is to assess annually the frailty of the population in these PACE organizations in order to adjust plan payment rates. Initial eligibility for payment purposes is based on community-residing participants who do not have end-stage renal disease (ESRD) and are 55 or over.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
A random sample of Medicare beneficiaries is drawn annually from each participating PACE organization and surveyed in the spring. Participants are defined as eligible for the HOS-M if they are enrolled in a participating PACE organization, reside in the community, do not have End Stage Renal Disease (ESRD), and are age 55 and over. Participants are randomly selected for HOS-M if the organization has a population of at least 1,400 participants. All eligible participants are included in the sample for PACE organizations with populations of less than 1,400.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
The Medicare HOS-M contains the following core components:
The HOS-M instrument is a shorter, modified version of the Medicare Health Outcomes Survey and contains 6 ADL items as the core items used to calculate the frailty adjustment factor for payment purposes. The survey also includes 12 physical and mental health status questions from the VR-12. In addition, the HOS-M includes questions about the following: lifting or carrying objects as heavy as 10 pounds; walking a quarter mile; health or physical problems interfering with daily activities, receiving help with ADLs; physical and emotional health compared to one year ago; memory loss; urinary incontinence; and a question on whether the survey was self-completed or completed by a proxy. If the participant received assistance completing the survey, the respondent was asked information about the proxy respondent.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
After each yearly administration of the Medicare HOS-M, a PACE organization-specific report is produced and is available for each PACE organization participating in the survey. The HOS-M report presents physical and mental component summary scores, ADL items, and selected health status measures for the frail, elderly Medicare beneficiaries for each organization compared to the entire HOS-M sample.
The corresponding beneficiary level data for a report are disseminated to participating PACE organizations. In addition to the data files, each PACE organization is provided with a Data User's Guide that describes the Medicare HOS-M file specifications and the appropriate use of Medicare HOS-M data.
All distribution of HOS-M reports occurs electronically to participating PACE organizations through CMS' Health Plan Management System (HPMS) in the fall of each year. Plans are alerted to report and data availability through HPMS and may request data from HOS Technical Support (hos@aqzio.sdps.org or toll free 888-880-0077).
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
Any program or policy questions concerning the HOS-M may be directed to hos@cms.hhs.gov. Additional information on both the HOS and HOS-M programs is available at http://www.hosonline.org/.
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11)
In addition to required CMS and State Administering Agency reporting, certain unusual incidents are regulated and must also be reported to other Federal and State agencies consistent with these agencies' requirements.
For example:
The PACE organization must make the notification(s) and take any prescribed actions within the prescribed time frame to comply with applicable statutory or regulatory requirements. Specific requirements can be found on the respective Federal or State agencies' websites.
| 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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