On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued new updated recommendations for providers to restart the provision care to patients without symptoms of COVID-19 entitled Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I. These new recommendations update the prior guidance issued by CMS on April 6, 2020 on limiting non-essential medical care, a summary of which is available here, and are part of the larger Guidelines for Opening Up America Again released by the Administration on April 16, 2020.

The Opening Up America Again guidelines stipulate that the phased approach and gating criteria discussed below may be implemented at the discretion of the state Governors on the state-wide or county-by-county level. As such, prior to proceeding with Phase 1 restarting of non-emergent and elective surgeries and procedures, providers should continue to evaluate state and local executive orders and emergency regulations that may include additional restrictions. As state departments of health begin to relax prohibitions and limitations on elective surgeries and procedures, we will update guidance for providers to reopen and restart operations.

CMS Recommended Guidelines

The latest CMS recommendations allow providers in states and regions that have relatively low and stable incidence of COVID-19 disease may resume in-person care of non-COVID-19 patients. Prior to resuming such services, the state or region must have passed the gating criteria set out in the Administration’s plan for opening American economic activity announced on April 16, 2020. Under the proposed gating criteria, a facility may begin Phase 1 activities to resume non-emergent care (such as certain procedural care (surgeries and procedures), chronic disease care, and, ultimately, preventive care) if the following conditions are met:

1. There has been a downward trajectory over a 14-day period of reported symptoms of:

   1. Influenza-like illness, and

   2. COVID-like syndromic cases

2. There has been a downward trajectory over a 14-day period of documented COVID-19 cases in the region, or a downward trajectory of positive tests as a percentage of the total tests completed, with the volume of testing remaining flat or increasing;

3. Hospitals in the region are able to treat patients without crisis care; and

4. There is a robust testing program in place for at-risk health care workings, including antibody testing.

If this threshold is met, CMS recommends that non-emergent elective services for non-COVID-19 patients should only resume if clinically appropriate and the state, region and facility has the resources to provide such care in a safe and effective manner while maintaining the ability to quickly respond to a potential surge in COVID-19 cases, if necessary. CMS leaves a significant amount of discretion and flexibility in the hands of providers, but sets out a series of recommendations to guide them in evaluating whether and how to resume in-person non-emergent services for non-COVID-19 patients in regions with low incidence of COVID-19 cases.

CMS continues to strongly advise providers to utilize telehealth, virtual check-ins, and remote monitoring wherever possible and clinically appropriate. Where utilization of telehealth modalities is not possible, individual cases should be evaluated for necessity based on clinical needs of the patient and the resources available. Services for high-complexity conditions, chronic disease management, or other high-acuity condition should be prioritized over lower acuity services. Providers should also keep in consideration the availability and conservation of personal protective equipment (PPE), availability of workforce across the phases of care, facility readiness, medical supply availability, and testing capacity.

With regard to the facility readiness considerations, CMS recommends that prior to restarting in-person, non-emergent services, providers should consider establishing distinct hospital spaces, dubbed Non-COVID Care (NCC) zones, within the facility. These NCC Zones would be separate and distinct from designated COVID-19 areas or floors, including a separate entrance at which patients and staff are screened for symptoms of COVID-19, to minimize the risk of crossover exposure.

STATE SPECIFIC CONSIDERATIONS

If the state or region has passed the proposed gating criteria and the general considerations discussed above have been addressed, then providers may, in collaboration with state and local public health authorities, consider resuming non-emergent surgeries and other elective medical services and procedures for patients without symptoms of COVID-19 that were postponed due to the declared public health emergency. However, before proceeding to reopen a service line under the CMS guidance, providers should review applicable state and local executive orders and emergency regulations, which could impose additional limitations.

CONCLUSIONS AND RECOMMENDATIONS:

• Review the availability of PPE and other medical supplies, workforce availability, facility readiness including creation of distinct NCC zones within the hospital, and testing capacity at both the facility and in the region. Hospitals may wish to consider use of non-traditional space to accommodate these new distinct zones – see Polsinelli’s guidance on the “Hospitals Without Walls” rules regarding such non-traditional spaces.

• Develop protocols for providing non-emergent care to non-COVID-19 patients that are tailored to the circumstances and ability of the individual facility to safely restart care.

• Ensure state and local guidance and emergency orders allow the hospital to resume providing non-emergent surgeries and other elective medical services and procedures, and do not impose additional or different requirements. Earlier in the response to the pandemic, many states required elective services be postponed or canceled. While those restrictions are being rolled back slowly, each state may apply different criteria for the types of permitted services, required precautions, and criteria for reopening. Providers should consult with legal counsel if they are unsure if the restrictions have been lifted or relaxed, or if they apply to the facilities’ specific practices.

• CMS also recommends a number of steps designed to limit accidental transmission of COVID-19, including the use of appropriate PPE by providers, face coverings by patients, routine symptomatic and (where available) clinical lab screening of staff and patients (including screening any patient prior to entering an NCC Zone), separation of staff assigned to NCC Zones, retaining enough staff to handle a future surge, and implementing  engineering controls for social distancing,

• Additional proactive steps that providers can take when resuming non-emergent elective services are discussed in more detail in our previous summary of the CMS recommendations available here.