On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued QSO 20-35 to state survey agency directors, instructing them to return to their normal survey process as soon as resources in the state allow and in accordance with each state’s reopening plan. The memorandum also provides guidance to states on how to resolve pending enforcement actions suspended as a result of prior QSO memorandums. IHCA will be meeting with ISDH this week to discuss the department’s interpretation of and plans to implement this CMS directive.
Specifically, on March 23, 2020, CMS issued QSO 20-20, which limited survey activity to focused infection control surveys. On June 1, 2020, CMS issued QSO 20-31, which provided survey re-prioritization guidance to transition to more routine oversight and survey activities. This latest memorandum instructs states to restart all normal surveys, as feasible, and IHCA/INCAL is actively working with the Indiana State Department of Health (ISDH) to understand their plans for implementation of QSO 20-35.
As outlined in QSO 20-35, CMS intends to resolve suspended enforcement cases and provided guidance for closing them out going forward. This process involves four components:
- Expanding the Desk Review policy for Plans of Corrections (POCs) – all open surveys between March 23, 2020 and May 31, 2020 may be desk reviewed if supporting evidence is provided from the facility, except any unremoved IJs as these will still require an onsite revisit;
- Processing enforcement cases that were started before March 23, 2020;
- For this period, accruing enforcement remedies will run through March 22, 2020, or the date of substantial compliance per the accepted POC, if that date is verified at the desk review, whichever date is earlier.
- Imposition of remedies will depend on when the initial notice of remedies was sent, before or after March 23, 2020.
- Surveys with exit dates after March 23, 2020, but that fell into an enforcement cycle started before March 23, 2020, will be pulled out of existing enforcement cycles and establish a separate cycle. This means that enforcement cycles that come about due to surveys after March 23rd are separate from those prior to March 23rd. An example of the timing between surveys before and after, and the enforcement cycle, is provided in the memo.
- Processing enforcement cases that were started on March 23, 2020, through May 31, 2020; and
- For this period, CMS will impose a PI or CMP on the IJ level noncompliance per the CMP analytic tool. If the CMP analytic tool leads to the imposition of a CMP, the CMP will only accrue for the period of time the IJ existed until removal was verified with an onsite revisit.
- Processing enforcement cases that were started on or after June 1, 2020.
- For this period, noncompliance will be subject to regular enforcement processes in the SOM and in line with the enhanced enforcement for infection control deficiencies outlined in QSO 20-31. However, for imposition of CMPs, if a survey finds that the first day of noncompliance started prior to the survey entrance and/or during the survey prioritization period (March 23, 2020 through May 31, 2020), CMS should start the CMP beginning the date of the survey entrance.
- For CMPs that were due between March 23, 2020 and May 31, 2020, but that were note paid, CMS will re-issue CMS notices with a new due data that is 15 days from that new notice.
CMS also issued updated guidance for the re-prioritization of routine Clinical Laboratory Improvement Amendments (CLIA) survey activities, subject to the state survey agency’s discretion, in addition to lifting the restriction on processing CLIA enforcement actions and issuing the Statement of Deficiencies and Plan of Correction (Form CMS-2567) for CLIA citations.
We encourage you to review the entirety of QSO 20-35, and we will update you when ISDH provides further guidance regarding its implementation. Questions for CMS on a specific enforcement cycle may be directed to: DNH_Enforcement@cms.hhs.gov.