Since the early stages of the Coronavirus (COVID-19) pandemic, long term care facilities (LTCFs) have been an epicenter of transmission. Medicare Requirements for Participation for LTCFs include an obligation to establish and maintain an infection control program designed to provide a safe, sanitary and comfortable environment that helps to prevent the development and transmission of communicable diseases and infection (42 CFR § 483.80). For many LTCFs, COVID-19 has made this a difficult requirement with which to comply, given the challenges presented by providing care in an environment that is both residential and clinical, the unique personal care needs of LTCF residents, and limited supplies of personal protective equipment and COVID-19 tests. Press reports have detailed the impact of COVID-19 on LTCFs nationally and internationally.
Routine surveys and inspections of LTCFs and other healthcare facilities were suspended at the height of COVID-19. Now that infection rates have started to decrease nationwide, the Centers for Medicare and Medicaid Services (CMS) has announced new instructions for state survey agencies to more intensively evaluate LTCFs and to cite facilities that fail to follow federal safety requirements. On June 1, 2020, CMS released a Quality, Safety and Oversight Group (QSO) memorandum (QSO 20-31) directing state survey agency directors on a series of new steps that CMS believes will safeguard the health and safety of LTCF residents by addressing infection control deficiencies in these facilities. These steps are to be implemented immediately, will cause a rapid uptick in survey activity and related enforcement effects for LTCFs, and will carry meaningful financial impact for states.
Focused Infection Control Nursing Home Surveys
As we previously reported, since March 4, 2020, state survey agencies have prioritized inspections of healthcare facilities to only the most serious matters. Subsequently, on March 23, 2020, state survey agencies were further instructed to limit their survey activities to just two situations:
- Complaints and facility-reported incidents that were triaged at the Immediate Jeopardy Level
- “Focused Infection Control Surveys” using a streamlined review checklist that focuses on critical elements associated with the transmission of COVID-19, including:
- Overall effectiveness of the LTCF’s infection prevention and control program
- Standard and transmission-based precautions
- Quality of resident care practices, including residents with laboratory-confirmed COVID-19 infections
- The facility’s surveillance plan
- Visitor entry and facility screening practices
- Education, monitoring and screening practices for staff
- Policies and procedures to address staffing issues during emergencies, including COVID-19 transmission.
CMS made the Focused Infection Control Survey checklist available to LTCFs and encouraged them to use it as a self-assessment tool and to discern CMS’s expectations for a thorough COVID-19 infection prevention and control program.
QSO 20-31 reports that as of June 1, 2020, approximately 54% of LTCFs had been subject to Focused Infection Control Surveys, with state averages ranging from 11% to 100% completion. Now that nursing homes are required to submit data to the Centers for Disease Control and Prevention (CDC) regarding instances of COVID-19 in their facilities (as we described here), CMS has articulated a need to prioritize Focused Infection Control Surveys by linking these efforts to receipt of Coronavirus Aid, Relief and Economic Security (CARES) Act funds.
Specifically, through the CARES Act, Congress has appropriated $81 million for state survey agencies to request for use in their survey and certification efforts, in addition to $397 million in previously budgeted funds. For states that have not performed 100% of LTCF Focused Infection Control Surveys in their states by July 31, 2020, CMS will require submission of a corrective action plan outlining the state survey agency’s plans for completion within 30 days. If the survey agency remains noncompliant during this 30-day extension, it may have its allocated 2021 survey funding reduced by up to 10%. For each subsequent 30-day period of noncompliance, CMS may impose further funds withholdings of 5%. In a June 1, 2020, press release announcing the enforcement actions discussed in QSO 20-31, CMS suggests that states that achieve CMS’s goal of 100% completion of Focused Infection Control Surveys in their states by July 31, 2020, will be permitted to request their entire 2020-2023 CARES-Act-related survey funds, and may apply to share in the pool of redistributed funds withheld from state survey agencies that did not achieve CMS’s performance goals.
Although it is yet to be determined whether CMS has the authority to withhold and redistribute apportioned funds in this way, state survey activities likely will increase significantly in June and July rather than risk jeopardizing access to this crucial money, even while many LTCFs are still battling COVID-19.
Additional LTCF Survey Activities
CMS also announced in QSO 20-31 the launch of additional obligatory state survey activities related to LTCFs and COVID-19. Failure to comply with these additional survey obligations may result in a state’s forfeiture of 5% or more of CARES Act survey funds.
- By July 1, 2020, state survey agencies must perform onsite surveys of any LTCF with a previous COVID-19 outbreak. CMS defines an outbreak as (i) total cases in excess of 10% of a LTCF’s total bed capacity, (ii) total cases plus total suspected cases in excess of 20% of a LTCF’s total bed capacity, or (iii) 10 or more reported deaths due to COVID-19. CMS did not specify whether cases involving staff should be included in these counts.
- State survey agencies must perform an onsite survey of any LTCF with three or more new suspected or confirmed COVID-19 cases within three to five days of identifying such cases in the event such cases arose in the time since the facility’s prior National Healthcare Safety Network (NHSN) report submitted to CDC. CMS did not specify whether cases involving staff would trigger a survey.
- Agencies must inspect facilities within three to five days of a confirmed COVID-19 case in a resident if that facility previously reported no COVID-19 cases.
- Beginning in 2021, agencies must perform Focused Infection Control Surveys on 20% of LTCFs in the state using the CMS Focused Infection Control Survey checklist. Facilities may be chosen at the state’s discretion using criteria meant to identify facility and community risk.
CMS is also calling on state survey agencies to return to their pre-COVID-19 survey activities once states have entered the third phase of CMS Nursing Home Reopening Guidance. Once this milestone is reached (or earlier at the state’s discretion), agencies are authorized to resume the following survey activities:
- Non-Immediate Jeopardy complaint investigations
- Revisits of facilities that addressed Immediate Jeopardy complaints but remain out of compliance
- Special Focus Facility and Special Focus Facility Candidate recertification surveys
- Recertification surveys for LTCFs and Intermediate Care Facilities for Individuals with an Intellectual Disability that are greater than 15 months.
CMS expects that surveyors will prioritize inspections based on facilities’ history of noncompliance or allegations of noncompliance involving abuse or neglect, infection control, transfer or discharge violations, insufficiency or incompetency of staff, or other quality of care issues. Accreditation bodies are also authorized to resume normal LTCF survey activities.
Enforcement Actions Against LTCFs Related to Infection Control Survey Deficiencies
CMS considers infection control deficiencies to be an ongoing compliance concern for LTCFs, and COVID-19 has highlighted the importance of compliance with CMS Requirements for Participation for infection control. To that end, QSO 20-31 addresses CMS’s plans to expand its enforcement efforts regarding infection control deficiencies.
In particular, CMS will use the following enforcement remedies if a survey shows an LTCF to be out of compliance:
- Infection control noncompliance with no prior citations during the last year or since the prior standard survey:
- Current non-widespread noncompliance (Level D&E) = Directed Plan of Correction
- Current widespread noncompliance (Level F) = Directed Plan of Correction, discretionary denial of payments for new admissions, 45 days to achieve compliance
- Infection control noncompliance with one prior citation during the last year or since the prior standard survey:
- Current non-widespread noncompliance (Level D&E) = Directed Plan of Correction, discretionary denial of payments for new admissions, 45 days to achieve compliance, civil monetary penalty up to $5,000 per instance
- Current widespread noncompliance (Level F) = Directed Plan of Correction, discretionary denial of payments for new admissions, 45 days to achieve compliance, civil monetary penalty (CMP) up to $10,000 per instance
- Infection control noncompliance with two or more prior citations during the last two years or in the period since the second-to-last prior standard survey:
- Current non-widespread noncompliance (Level D&E) = Directed Plan of Correction, discretionary denial of payments for new admissions, 30 days to achieve compliance, civil monetary penalty up to $15,000 per instance (or a per day CMP that exceeds $15,000 in total)
- Current widespread noncompliance (Level F) = Directed Plan of Correction, discretionary denial of payments for new admissions, 30 days to achieve compliance, CMP up to $20,000 per instance (or a per day CMP that exceeds $20,000 in total)
- Infection control noncompliance at the Harm Level (Levels G, H or I) = Directed Plan of Correction, discretionary denial of payments for new admissions, 30 days to achieve compliance, CMP at the highest non-Immediate Jeopardy level
- Infection control noncompliance at the Immediate Jeopardy Level (Levels J, K or L) = Mandatory temporary manager or termination of Medicare enrollment, Directed Plan of Correction, discretionary denial of payments for new admissions, 15 days to achieve compliance, CMP at the highest Immediate Jeopardy level.
Quality Improvement Organization Support
While CMS is increasing its survey activities, it is also providing resources for LTCFs to prepare for infection control surveys and assist in their efforts to address the COVID-19 crisis. Twelve Quality Improvement Organizations (QIOs) received contracts in 2019 to educate and train LTCFs on infection control, prevention and management. QIOs are not survey agencies; rather, their role is to help LTCFs identify deficiencies, create an action plan, and take specific steps to implement infection control and surveillance programs, including through weekly National Infection Control Training sessions. Going forward, QIOs will be deployed to provide technical assistance to 3,000 low performing nursing homes with a history of infection control challenges. States may also request that QIOs provide technical assistance to LTCFs that experienced a COVID-19 outbreak.
Public Data Posting
LTCFs were required to submit their first COVID-19 incidence data to NHSN by May 31, 2020. CMS’s preliminary analysis of this data indicates that facilities with a one-star CMS quality rating were more likely to have large numbers of COVID-19 cases than facilities with a five-star CMS quality rating. In a June 4, 2020, QSO memorandum (QSO 20-32), CMS notified stakeholders that the data would be populated on the Nursing Home Compare website and at https://data.cms.gov/Covid19-nursing-home-data, on June 4, 2020, and updated on a weekly basis, to allow the public to see how COVID-19 has affected nursing homes by state, number of residents and number of staff. Data will also be searchable by facility name. Data will include each facility’s name, the number of confirmed and suspected COVID-19 cases among residents and staff, the number of resident deaths related to COVID-19, availability of PPE and COVID-19 testing, and potential staffing shortages. Relatedly, in a separate June 4, 2020, QSO memorandum (QSO 20-33), CMS notified stakeholders that it would post results of surveys conducted at LTCFs on or after March 4, 2020, on the Nursing Home Compare website. Data will include a spreadsheet of each health inspection conducted, the facility’s demographic information and any findings or citations associated with the inspection. The website will be updated on a monthly basis.
CMS states that all policies articulated in QSO 20-31 are immediately effective and will remain in effect until CMS provides public notice that the COVID-19 Public Health Emergency has ceased. We anticipate that the content of QSO 20-31 will eventually be included as part of the interpretive guidance provided to surveyors as part of the Medicare Requirements for Participation. The public data reporting plans articulated in QSO 20-32 and QSO 20-33 are also immediately effective. CMS did not state whether these postings would sunset when the COVID-19 crisis and reporting obligations cease.
QSO 20-31 represents an important step in addressing infection control practices at LTCFs, but it likely will be accompanied by material challenges for LTCFs in regions with active COVID-19 transmission. LTCFs may wish to prepare themselves as follows:
- Review QSO 20-31 and become familiar with the new enforcement regime.
- Prepare for heightened governmental scrutiny through numerous intensive surveys, many of which may be repeated.
- Continue to maintain sufficient stores of PPE to provide to onsite inspectors to avoid any outside contamination. Remember that facilities may insist on screening anyone coming onsite and barring entry to anyone exhibiting symptoms.
- Identify any potential citations through the use of the CMS self-assessment checklist. If possible, address those issues, or document any attempts to mitigate such issues and why full resolution was not practicable.
- Contact trade associations and advocacy groups for more information or to articulate any concerns with QSO 20-31. Peers may be similarly situated, and a collective voice may lead CMS to scale back the survey and enforcement timeline until the COVID-19 crisis is better managed.
- Continue to monitor state and industry guidance for information regarding assistance from QIOs.
- Notify public relations teams that self-reported COVID-19 data and results from surveys are now publicly available and inquiries from residents, families, media and other stakeholders may be forthcoming.