On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) announced in a memo to State Survey Agency Directors (QSO-20-35-ALL) the resumption of certain routine surveys and inspections of healthcare providers and suppliers, including on-site complaint investigations, surveys and revisits/revalidations, once sufficient staff and necessary personal protective equipment are available.
In March 2020, during the initial response to the coronavirus (COVID-19) public health emergency (PHE), CMS first prioritized (QSO-20-12-ALL) and then severely restricted (QSO-20-20-ALL) all survey activity aside from certain high-priority surveys, which included infection control surveys and the investigation of complaints and incidents alleging immediate jeopardy (IJ) to patient health and safety. Most enforcement actions were also suspended at that time. CMS’s latest guidance comes after a more limited expansion of survey activities in June, when the agency issued re-prioritization guidance (QSO-20-31-ALL) that directed states to resume certain surveys for all provider and supplier types once they had reached Phase 3 of CMS Nursing Homes Reopening Recommendations for State and Local Officials (QSO-20-30-NH), or earlier at the state’s discretion.
In addition to directing the resumption of additional on-site survey activity for long-term care facilities, this most recent CMS guidance encourages states to resume normal survey activity for other types of providers once the states reach Phase 3 of the Administration’s “Opening Up America Again” guidance for state/regional reopening (or earlier at their discretion), following the survey priorities set forth in the CMS FY 2020 Mission & Priority document. States are also encouraged to work through the backlog of surveys postponed because of the PHE. States are to work with their local CMS offices to prepare a proposed timeframe for completion of these surveys.
CLIA Labs
QSO-20-35-ALL also announced CMS re-prioritization guidance for survey activities associated with Clinical Laboratory Improvement Amendments (CLIA) labs. In particular, CMS recommends that states resume most on-site surveys and proceed with enforcement actions or PT desk reviews that have been on hold. These lab-focused recommendations are subject to state discretion and each state’s “unique COVID-19 restrictions and safety precautions.”
Plan of Action to Resolve Suspended Provider Enforcement Actions
In its March 2020 guidance in QSO-20-20-ALL, CMS announced a period of enforcement discretion during which it suspended provider enforcement actions except for those related to unremoved IJs, and stayed accrual of certain related financial penalties for long-term care providers. CMS has now established a process to begin resolving these enforcement actions, depending on the date and stage of the enforcement action. In QSO-20-35-ALL, CMS provides that state survey agencies may review plans of corrections (POCs) via an “expanded desk review” and without an on-site survey (except for unremoved IJs) for those enforcement actions that were started between March 23 and May 31, 2020, under which providers were permitted to delay their submission of a POC. Under this new process, providers will generally have 10 calendar days to submit their POCs and supporting evidence for any such surveys that ended prior to June 1, 2020. Normal POC submission processes and on-site revisits are authorized for surveys that end on or after June 1, 2020. Providers in areas where there is a current COVID-19 outbreak may request extensions to the POC submission timeline.
The new CMS guidance details the different ways in which the agency will proceed to resolve provider and supplier enforcement cases that fall into three categories: those (1) initiated prior to March 23, 2020; (2) initiated between March 23 and May 31, 2020; or (3) initiated on or after June 1, 2020. Civil monetary penalties (CMPs) and denials of payment for new admissions will be calculated differently for each of these categories, and CMP due dates will be adjusted. In addition, CMPs will not be imposed for noncompliance below the Actual Harm or IJ levels for enforcement cycles that started between March 23 and May 31, 2020.
Key Takeaways
Providers and suppliers should prepare for the immediate possibility of on-site survey activity and the resumption of any suspended survey or enforcement processes that started before or during the early stages of the PHE. Where current COVID-19 outbreaks restrict the resources available to complete POCs, extensions of time to submit may be granted on a case-by-case basis. Notwithstanding this flexibility, the most recent CMS guidance signals that the “next normal” for all provider types will include a near-term return to robust survey activity through a combination of expanded desk reviews and on-site surveys, and a resumption in suspended and new enforcement actions.
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