CMS issues guidelines for resuming elective procedures

On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) published guidance (the “CMS Guidance”) for reopening facilities to provide elective procedures or “non-emergent, non-COVID-19 healthcare.” The CMS Guidance was issued in connection with the White House’s Guidelines for Opening Up America Again, which indicate that elective surgeries can resume once a state or region meets the gating criteria necessary to start Phase 1 of the White House guidelines.

The gating criteria for Phase 1 are (a) a downward trajectory of influenza-like illnesses and COVID-like syndromic cases reported within a 14-day period; (b) a downward trajectory of documented cases or positive tests as a percentage of total tests within a 14-day period (i.e., flat or increasing volume of tests); and (c) hospitals in the region can treat all patients without crisis care and have robust testing programs in place for at-risk healthcare workers, including emerging antibody testing.

Although the CMS Guidance strongly encourages the maximum use of telehealth services, it provides recommendations for resuming in-person care of non-COVID-19 patients when care cannot be accomplished virtually. The CMS Guidance is applicable to facilities in regions with low incidence of COVID-19, and it specifically states that facilities should continually evaluate whether their region remains a low risk of incidence and should be prepared to cease non-essential procedures if there is a surge.

The CMS Guidance contains a long list of considerations that aim to give healthcare facilities some flexibility in “providing essential non-COVID-19 care to patients without symptoms of COVID-19 in regions with low incidence of COVID-19.” Notably, the considerations state that patients and providers who enter facilities that provide elective procedures should be screened for COVID-19 by laboratory tests when adequate testing capacity is established. Additionally, one of the criteria that can be used to justify entering Phase 1 is a downward trajectory of positive tests as a percentage of total tests over a 14-day period. As a result, it may not be feasible to restart a significant amount of elective procedures until near-ubiquitous testing for COVID-19 is available.

The considerations in the CMS Guidance are as follows:

General Considerations

• In coordination with state and local public health officials, facilities should evaluate the incidence and trends for COVID-19 in the area where re-starting in-person care is being considered.
• Facilities should evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical/procedural care and high-complexity chronic disease management. Select preventive services, however, may also be highly necessary.
• Facilities should consider establishing Non-COVID Care (NCC) zones that would screen all patients for symptoms of COVID-19, including temperature checks. Staff and all others who work in or enter the facility (physicians, nurses, housekeeping, delivery personnel, and others) would be routinely screened.
• Sufficient resources should be available to the facility across phases of care, including PPE, healthy workforce, facilities, supplies, testing capacity, and post-acute care, without jeopardizing surge capacity.

Personal Protective Equipment

• Consistent with the CDC’s recommendations for universal source control, healthcare providers and staff should wear surgical facemasks at all times. Procedures on the mucous membranes including the respiratory tract, with a higher risk of aerosol transmission, should be performed with great caution, and staff should utilize appropriate respiratory protection such as N95 masks and face shields.
• Patients should wear a cloth face covering that can be bought or made at home if they do not already possess surgical masks.
• Every effort should be made to conserve personal protective equipment consistent with the CDC’s guidance.

Workforce Availability

• Staff should be routinely screened for symptoms of COVID-19 and, if symptomatic, they should be tested and quarantined.
• Staff who will be working in NCC zones should be limited to working in these areas and not rotate into “COVID-19 Care zones” (e.g., they should not have rounds in the hospital and then come to an NCC facility).
• Staffing levels in the community must remain adequate to cover a potential surge in COVID-19 cases.

Facility Considerations

• In a region with a current low incidence rate, when a facility makes the determination to provide in-person, non-emergent care, the facility should create areas of NCC that have in place steps to reduce risk of COVID-19 exposure and transmission. These areas should be separate from other facilities to the degrees possible (i.e., in a separate building or in designated rooms or floor(s) with separate entrances and minimal crossover with COVID-19 areas).
• Within the facility, administrative and engineering controls should be established to facilitate social distancing, such as minimizing time in waiting areas, spacing chairs at least six feet apart, and maintaining low patient volumes.
• Visitors should be prohibited. If, however, they are necessary for an aspect of patient care, they should be pre-screened in the same way as patients.

Sanitation Protocols

• Ensure that there is an established plan for thorough cleaning and disinfection prior to using spaces or facilities for patients with non-COVID-19 care needs.
• Ensure that equipment such as anesthesia machines used for COVID-19 positive patients are thoroughly decontaminated, following CDC guidelines.

Supplies

• Adequate supplies of equipment, medication and supplies must be ensured, and not detract from the community’s ability to respond to a potential surge.

Testing Capacity

• All patients must be screened for potential symptoms of COVID-19 prior to entering the NCC facility, and staff must be routinely screened for potential symptoms as noted above.
• When adequate testing capability is established, patients should be screened by laboratory testing before care, and staff working in these facilities should be regularly screened by laboratory test as well.