Introduction to QAPI
Pursuant to § 6201(c) of the Patient Protection and Affordable Care Act (ACA), the Centers for Medicare and Medicaid Services (CMS) have issued interim guidance governing the implementation of the newly created Quality Assurance Performance Improvement (QAPI) program in the long-term care setting. The QAPI program for nursing homes merges CMS’ Quality Assurance (QA) and Performance Improvement (PI) programs to implement a systematic, comprehensive, data-driven and proactive approach to performance management and quality improvement. In other words, QAPI is essentially a set of “best practices” and quality assessment and improvement guidelines aimed at improving the quality of care provided in long-term care facilities. Until CMS promulgates formal regulations, as it is required to do under the ACA, long-term care facilities should adhere to interim QAPI guidance published by CMS. More importantly, when engaging in the data-driven, self-assessment processes encouraged under the QAPI program, long-term care facilities should adhere to certain formalities to be sure QAPI-related documents and reports remain privileged and confidential.
Interim QAPI Guidance
Although no regulations have been issued to date, CMS has published interim guidance for long-term care facilities. In 2012, for example, CMS issued QAPI at a Glance, which is a detailed how-to-guide that encourages health care providers to implement robust quality assurance programs. QAPI at a Glance is divided into 12 steps, many of which recommend that long-term care facilities record, compile, review and compare quality assurance data. Many, if not most of these 12 steps, encourage long-term care facilities to engage in a comprehensive, self-critical analysis of various quality assurance and performance improvement opportunities within the facility. It is critical that those engaging in this type of analysis take certain precautions to be sure documents and other reports generated pursuant to QAPI guidelines are shielded under the quality assurance privilege.
Maintaining QAA Privilege for QAPI Documents
QAPI is an expansion of existing Quality Assessment and Assurance (QAA) requirements, codified in 42 C.F.R. § 483.75(o). The QAA regulations explicitly state that certain documents or reports created pursuant to a long-term care facility’s QAA program will be privileged and confidential (the “QAA Privilege”). Specifically, 42 C.F.R. § 483.75(o)(3) contains the following provision: “A State or the Secretary may not require disclosure of the records of [a QAA] committee [unless] such disclosure is related to the compliance of such committee with the requirements of this section.” Thus, in order to be shielded by QAA Privilege, documents or reports created for use at a QAA committee meeting, including documents or reports created pursuant to QAPI guidelines, should not raise issues of regulatory noncompliance; rather, such reports should focus only on quality assurance and performance improvement opportunities.1
To increase the likelihood that QAPI documents or reports are protected by the QAA Privilege, long-term care facilities should adopt the following six policies:
Ensure that QAPI documents do not raise issues of regulatory noncompliance;
Clearly mark QAPI documents as confidential and created pursuant to QAPI and under the direction of the QAA committee;
Ensure that QAPI documents are created, stored and reviewed by members of the QAA committee;
Preserve QAPI meeting minutes that refer to QAPI documents;
Do not use QAPI documents for non-QAPI purposes (avoiding “mixed uses” will decrease the likelihood of inadvertently waiving the QAA Privilege); and
Include attorneys in the QAPI review process, whenever possible.
*Thank you to Summer Associate Jackson Warren for his contributions to this article.
1Notably, documents created during a QAA committee meeting will likely be protected by the QAA Privilege. This is because CMS distinguishes between records of QAA committee meetings, which generally are privileged, and documents used by the QAA committee, which generally are not.