What was in the recent CMS proposed rule regarding Phase 3?
Andy Kramer, MD
10/1/2019
In the July 18, 2019, Federal Register, the Centers for Medicare & Medicaid Services (CMS) proposed a rule that will reform some of the Phase 3 requirements that have been identified as “unnecessary, obsolete, or excessively burdensome.”
The major provisions fall into three areas: designation and training of the infection preventionist, the compliance and ethics program, and Quality Assurance Performance Improvement (QAPI). The rule would also delay implementation of some of the provisions in these three areas for a year.
The change to the requirements related to the infection preventionist (IP) removes the need to hire for this role, allowing facilities the flexibility to contract with an individual or in some other way ensure they have the capacity to meet the needs of the infection prevention and control program (IPCP).
While there is considerable affirmation in the rule that an IPCP is an important requirement that providers should continue to initiate, this modification acknowledges that facilities will have different approaches to meeting these requirements that, in many cases, will not require an additional position.
The change to the compliance and ethics program removes many requirements in this area, including the need for a compliance officer, compliance liaisons, and reviewing the compliance program annually.
As CMS and providers have all struggled with defining how this adds to quality of care in a way that is not already covered by existing regulations, it is a welcome relief to all that this be reconsidered and probably reduced substantially in the final rule.
Eliminating the prescriptive requirements that CMS set forth for a QAPI program does not lessen the requirement that providers proceed with the design and implementation of a robust QAPI program and provide documentation of it at survey. Instead, it recognizes a couple of realities about the QAPI regulations.
First, CMS and state survey agencies have limited experience in assessing implementation of a QAPI program or assessing a program’s effectiveness. Considerable preparation and training will be required for CMS to develop standard compliance assessment of QAPI programs, while also preserving the quality assurance privilege that is necessary for providers to effectively conduct QAPI.
Second, QAPI has been used in health care for many years, taking different forms depending on the setting, staffing, and quality challenges the organization faces. For organizations to identify potential quality concerns, address their underlying causes, and avoid repeating prior quality problems, systematic QAPI methods offer much greater benefits than older methods of finding and fixing quality issues one at a time as they arise.
That said, successful QAPI programs have to be implemented in the context of how each organization operates, not according to some rigid set of rules that are intended to apply to all organizations.
The emphasis on provider-driven QAPI programs offers an opportunity for nursing centers to develop compliant QAPI programs, tailored to operations and services provided, that improve quality of care and increase satisfaction of everyone involved.
The current survey process has resulted in fewer deficiencies and enforcement actions, even since the new regulations came into effect in May. Thus, the opportunities to ensure quality are increasingly in our hands. What will we do with them?