By Paula Sanders

Law360 (June 12, 2020, 6:45 PM EDT) --

Paula Sanders

On June 1, the Centers for Medicare & Medicaid Services released new COVID-19 infection control survey and enforcement guidance to state survey agencies, or SSAs.[1] The ramifications for SSAs, long-term care facilities and skilled nursing facilities, or SNFs, are monumental, especially in those states, like Pennsylvania, where surveyors have been conducting the majority of surveys remotely.

Responding to intense criticism about insufficient oversight of SSAs, CMS has developed a performance-based funding requirement tied to the Coronavirus Aid, Relief and Economic Security, or CARES, Act supplemental grants for SSAs. CMS has also created a new sanctions paradigm for SNF deficiencies related to infection control requirements. Facilities should prepare now for increased on-site survey scrutiny.

States' Performance Funding is at Risk

On-Site Focused Infection Control Surveys

Under the new guidance, SSAs must complete 100% of on-site focused infection control surveys by July 31. Any state that fails to complete 100% of these surveys by then will be required to submit a corrective action plan to CMS explaining how it will complete the remaining focused infection control surveys within 30 days.

Any state that fails to complete 100% of the focused infection control surveys by Aug. 30 will lose 10% of its CARES Act fiscal year 2021 allocation. A state's continued failure to hit the 100% completion rate for focused infection control surveys could result in another 5% reduction. Those states that have hit the 100% completion benchmark by July 31 will be eligible to receive a proportion of the funds that have been forfeited by the delinquent states.

Starting in fiscal year 2021, SSAs must perform annual focused infection control surveys of at least 20% of SNFs using their discretion or additional data that identifies facility and community risks. The failure to do so will subject the state to forfeiture of up to 5% of its annual CARES Act allocation.

According to data from CMS,[2] Pennsylvania has only completed 113 (16.3%) on-site, focused infection control surveys. The national average for SSA completion of these surveys is approximately 54%. Only four states have a lower completion rate. Pennsylvania needs to conduct on-site focused infection control surveys at 582 more SNFs to qualify for its full CARES Act allocation by July 31.

On-Site COVID-19 Focused Surveys

SSAs also risk forfeiture of up to 5% of their CARES Act allocation annually if they fail to perform certain COVID-19 survey activities. State-specific data is not currently available, but it is likely that states like Pennsylvania will be under extraordinary pressure to conduct additional on-site surveys along with the focused infection control surveys.

SSAs have only 30 days from June 1 to perform on-site surveys of any SNF with a previous COVID-19 outbreak. CMS defines "previous COVID-19 outbreak" as:

• Cumulative confirmed cases/bed capacity at 10% or greater; 
• Cumulative confirmed plus suspected cases/bed capacity at 20% or greater; or
• Ten or more deaths reported due to COVID-19.

Individual facilities should immediately determine whether they fall into one of the above-listed triggers, and whether they have had an on-site COVID-19 focused survey. We expect that SSAs will prioritize these facilities for on-site surveys, which likely will include scrutiny of both infection control and COVID-19 survey protocols if either has not already occurred.

Additionally, SSAs must also perform on-site surveys within three to five days of the identification of any nursing home with three or more new COVID suspected and confirmed cases as reported in the National Healthcare Safety Network COVID-19 report. SSAs will also be required quickly to conduct these surveys at any facility that reports one confirmed resident case in a facility that was previously COVID-19 free.

Facilities should be aware that the NHSN reporting system does not distinguish between facility-acquired and facility-admitted cases. Facilities that admit COVID-19 positive patients from the hospital may be placing themselves at risk of increased survey scrutiny. The potential risk may be compounded in those states that require facilities to admit patients whose COVID-19 status is unknown or pending. The risk is much lower in states that do not want their SNFs to accept any known COVID-19 positive cases.

Are Surveyors Prepared?

In its CMS COVID-19 focused survey protocol,[3] CMS has advised SSAs that they must ensure surveyors have needed personal protective equipment, or PPE, that could be required on-site. In addition, surveyors must be medically cleared, and trained in the proper use of respirators, safe removal and disposal, and medical contraindications to respirator use. For some SSAs, this may present a staffing challenge.

One can only hope that SSAs do not look to SNFs to provide their PPE to surveyors, as PPE continues to be in very short supply in many locations.

CMS Gives States Flexibility to Expand Survey Activities

Referencing its nursing home reopening guidance,[4] CMS wants states to transition to more routine survey activities once the state has entered Phase 3, or earlier at the state's discretion. This means that states will be able to move beyond the current survey priorities (immediate jeopardy, focused infection control and initial certification surveys) for all provider types. States are now authorized to conduct the following survey activities:

• Complaint investigations that are triaged as nonimmediate jeopardy-high;

• Revisit surveys of any facility with removed immediate jeopardy (but still out of compliance);

• Special focus facility and special focus facility candidate recertification surveys; and

• Nursing home and intermediate care facility for individuals with intellectual disability recertification surveys that are greater than 15 months.

These surveys should be prioritized based on a facility's prior survey history and allegations related to abuse or neglect; infection control; transfer/discharge; insufficient staffing or competency; or other quality of care issues.

A return to the new normal for SNFs seems likely to include focused infection control surveys, at least for the foreseeable future.

Enhanced Sanctions for Infection Control Deficiencies

CMS has created new enforcement sanctions specifically related to noncompliance with infection control requirements. These remedies increase in severity based on the facility's prior infection control history as well as the perceived risk to residents from the identified noncompliance. CMS perceives a "heightened threat to resident health and safety for even low-level isolated infection control citations (such as proper hand washing and use of PPE)." CMS believes that expanded enforcement will improve accountability and sustained compliance with fundamental health and safety protocols.

CMS is defining "substantial noncompliance" (D or above) with infection control requirements. The new sanctions include directed plans of correction, including use of root cause analysis, discretionary denial of payment for new admissions, per instance civil money penalties and per day civil money penalties, among others. The chart below illustrates the new sanctions, based on scope and severity and facility history.



It is unfortunate that CMS has chosen to punish SNFs instead of working with them in a more supportive and collaborative fashion. One wonders how increasing financial penalties or imposing denials of payment for new admissions will ever help improve care, particularly in the middle of a pandemic where staff and supplies are at a premium.

Diverting funds away from patient care seems counterintuitive at this moment in history. Consider that according to the American Health Care Association, the estimated cost of mandatory SNF testing nationally[5] is approximately $440 million, and testing every Pennsylvania nursing home resident and employee — just once — would cost $22,229,550.

Experts agree that the timing of this new CMS initiative is questionable at best, and perhaps misguided because evidence suggests that infection control issues and quality ratings are not indicative of COVID-19 breakouts. Rather, factors such as race, geography, facility size and community spread are more closely tied to outbreaks than overall quality.[6]

CMS' national data[7] shows that some states, like Pennsylvania, experienced a very high penetration of COVID-19 cases in their SNFs. This may be more reflective of the conflicting guidance given by state agencies regarding critical interventions such as cohorting, use and allocation of PPE, testing, taking admissions from hospitals, to name but a few, and not an indictment of the quality of infection control in the country's nursing homes.

Expanded Role of Quality Improvement Organizations 

CMS is deploying QIOs to provide technical assistant to nursing homes. Approximately 3,000 low-performing nursing homes with a history of infection control challenges have been targeted as a focus for the QIOs.

States may request QIO technical assistance for a specific nursing home. CMS has also reminded facilities that they can access weekly national infection control training[8] that focuses on infection control, prevention and management to help prevent the transmission of COVID-19.

What Lies Ahead?

SSAs around the country are reevaluating survey schedules and staff deployment issues, especially in those states that are far below the 100% benchmark for completing on-site focused infection control surveys. They are also reviewing SNF-specific data to identify those facilities that have had past COVID-19 outbreaks to ensure that they have had an on-site COVID-19 focused survey before July 1. No state wants to risk not receiving their full CARES Act allocation.

SNFs are continuing their heroic work in taking care of their residents during this pandemic. They continue to look for full support and partnership with the regulators through this siege. While unlikely, they hope that CMS will rescind this policy directive to give SNFs and SSAs time to work collaboratively to keep COVID-19 at bay. In the meantime, they carry on with following federal and state guidelines, and prepare for the fresh onslaught of new survey scrutiny.

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Paula G. Sanders is the co-chair of the health care practice group and chair of the COVID-19 task force at Post & Schell PC.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] https://www.cms.gov/files/document/qso-20-31-all.pdf.

[2] https://www.cms.gov/files/document/6120-nursing-home-covid-19-data.pdf.

[3] https://qsep.cms.gov/data/274/COVID-19FocusedSurveyProtocol.pdf.

[4] https://www.cms.gov/files/document/qso-20-30-nh.pdf-0.

[5] https://www.ahcancal.org/facility_operations/disaster_planning/Documents/State%20by%20State%20Breakdown_
COVID%20Testing%20for%20Nursing%20Homes%205.20.20.pdf.

[6] https://skillednursingnews.com/2020/06/during-a-pandemic-boosting-infection-control-fines-on-nursing-homes-may-do-more-harm-than-good/ (June 3, 2020).

[7] https://www.cms.gov/files/document/6120-nursing-home-covid-19-data.pdf.

[8] https://qioprogram.org/nursing-home-trainings.

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