Deep Dive #1: The Proposed QAPI Standard
The Centers for Medicare & Medicaid Services (“CMS”) released revised home health conditions of participation (“proposed CoPs”) on October 6, 2014. Home health agencies (“HHAs”) and the health systems or providers with which they work should take a close look at the proposed changes, as they will certainly impact the future of the home health delivery system.
The topic of this article’s analysis is the removal of the group of professional personnel condition. It is replaced with a brand new condition for Quality Assurance and Performance Improvement (“QAPI”).1 The trend towards quality improvement programs is not new; most home health agencies have some sort of quality improvement program in place. And for hospitals and hospices, QAPI program requirements are already in their CoPs, and the nursing home industry’s QAPI requirements are in development. Much like the hospital and hospice QAPIs, the proposed CoPs for home health agencies provide a detailed framework that is intended to be flexible so that large and small agencies alike can each choose to implement the standard in ways that comport with their potential concerns and resources. This proposed condition is also intended to move responsibility for quality from a single group of professionals and make it the responsibility of all professionals within the agency. This will place more responsibility on and require more involvement by the agency’s governing body. Hospitals and health systems with experience in QAPI may be valuable partners to home health agencies as they navigate establishing, revising and improving their QAPI performance.
Although the QAPI condition does not spell out a specific, one-size-fits-all program, the framework provides key requirements that a program must meet. The condition requires the governing body to ensure that the QAPI program: (1) “reflect the complexity of its organization and services”; (2) cover all services provided by the HHA; (3) focus on indicators related to improved outcomes; and (4) take action that improves outcomes across the spectrum of care.2 The governing body is required to ensure that an ongoing program for quality improvement and patient safety is “defined, implemented and maintained.”3 This will be an ongoing governing body function that will need to be documented in board minutes, through board resolutions, etc.
The governing body will also be responsible for ensuring that QAPI efforts “address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness.”4 Similarly, the proposed QAPI condition will require the governing body to set clear expectations regarding patient safety and to ensure findings of fraud or waste are addressed.5 The governing body will have a significant role to play in your QAPI efforts. This will not be a day-to-day operational role but will be a leadership role that involves setting priorities. This may also include ensuring there are sufficient resources to operate a QAPI program with enough complexity to achieve the goals of the CoP. Again, hospitals and health systems already experienced in the QAPI space may be valuable partners in achieving these quality goals.
The governing body will also be responsible for addressing fraud and waste. This concept raises a number of questions. CMS appears to think a QAPI program may uncover evidence of fraud and waste, but that is more likely a result of compliance diligence and review. A QAPI program that is measuring performance against Outcome and Assessment Information Set (“OASIS”) data and other benchmarks could, in theory, uncover evidence that visits were not occurring as scheduled or other types of fraud. However, the real concern here is that CMS is now making the process of properly identifying and addressing findings of fraud and waste a part of the proposed CoPs.
The QAPI program itself will need to rely upon objective measures, such as data, to track agency performance. This means agencies will have to identify standards against which they can measure their performance. The proposed QAPI condition will require agencies to look at OASIS data, Outcome-Based Quality Improvement for example, CASPER reports, homehealthquality.org and similar sources. In the comments, CMS states that “surveyors would expect HHAs to demonstrate, with the objective data from the OASIS data set and other sources available to the HHA, that improvements had taken place with respect to actual care outcomes, processes of care, patient satisfaction levels and/or other quality indicators.” This will be an ongoing process of identifying areas, determining objective goals, measuring your performance against those goals, achieving the goals and then maintaining the performance.
CMS has identified sources of data to use, but another key issue is how agencies should pick the areas to measure. The proposed QAPI condition provides a number of areas to consider for performance improvement (“PI”) projects. The proposed QAPI condition states that agencies should focus their performance improvement projects on “high risk, high volume, or problem-prone areas.”6 Agencies should also consider “the incidence, prevalence, and severity of problems in those areas as a means to determine which issues on which to focus.”7Finally, the agency’s QAPI efforts should “lead to an immediate correction of any identified problem that directly or potentially threatens the health and safety of patients.”8
Of course, QAPI is about more than simply measuring outcomes. Once agencies have identified the measures they will use for a PI project, the agency must then determine actions that will lead to improvement of the outcomes measures they have selected.9 Agencies will then need to implement these processes and then measure their outcomes.10 Once the agencies have achieved their desired goals, as determined by their chosen outcomes measures, agencies will need to continue to track performance to ensure gains are maintained.11
The process of identifying, measuring, planning, implementing, measuring and monitoring will be applicable to each PI project the agency undertakes during a year. The agency will be expected to choose a number of projects and a scope for each project that is commensurate with the “scope, complexity and past performance of the HHA’s services and operations.”12 Agencies will be required to document “the projects undertaken, the reasons these particular projects were undertaken and the measurable progress achieved on these projects.”13
Overall, the proposed QAPI condition provides agencies with a significant degree of flexibility to implement QAPI, or modify a current QAPI program, in a manner that fits with the agency’s operations. Regardless of the specifics of an agency’s implementation, the proposed QAPI standard will require a detailed, objective, ongoing and well-documented QAPI effort. QAPI will no longer just be about the group of professional personnel, but it will be agency-wide and go all the way up to the governing body and/or health system partners. Agencies will need to thoroughly document their efforts from the initiation of the QAPI program through selection of ongoing efforts, monitoring improvements, reporting to the governing body, etc.
Most agencies are already engaged in QAPI at some level. Agencies will need to consider if their QAPI efforts are as broad in scope and documented in the length of detail as this proposed standard will require.
If you have any questions or would like additional information about this topic, please contact:
- Robert W. Markette at (317) 977-1454 or rmarkette@wp.hallrender.com;
- Allison L. Taylor at (317) 977-1421 or ataylor@wp.hallrender.com; or
- Your regular Hall Render attorney.
Special thanks to John Bowen, Grace Shelton, Maryn Wilcoxson and Alli Potenza for their assistance with the preparation of this article.
Please visit the Hall Render Blog for more information on topics related to health care law.
1 See proposed regulation 42 C.F.R. §484.65
2 Proposed §484.65
3 Proposed §484.65(e)(1)
4 Proposed §484.65(e)(2)
5 Proposed §484.65(e)(3)-(4)
6 Proposed §484.65 (c)(1)(i)
7 Proposed §484.65 (c)(1)(ii)
8 Proposed §484.65 (c)(1)(iii)
9 Proposed 484.65 (c)(3)
10 Id.
11 Id.
12 Proposed §484.65(d)(1)
13 Proposed §484.65 (d)(2)
