Update (June 12): The Centers for Medicare & Medicaid Services released Phase II recommendations for healthcare providers reopening for non-emergent, non-COVID-19-related services. For eight key considerations for healthcare providers based on those recommendations, see this June 12, 2020, McGuireWoods legal alert.
The Centers for Medicare & Medicaid Services (CMS) recently released its first phase of recommendations regarding reopening medical facilities for the provision of non-emergent procedures unrelated to the 2019 novel coronavirus (COVID-19).
CMS’ guidance focuses on regions of the country with low and stable incidence of COVID-19. For those regions, these new recommendations relax CMS’ guidelines issued several weeks ago for postponing adult non-essential medical, surgical and dental procedures, as discussed in McGuireWoods’ March 20, 2020, alert. In a statement accompanying this new guidance, CMS Administrator Seema Verma noted that a more “tailored and flexible approach” is now appropriate when weighing whether restrictions on non-essential procedures should continue, given that some areas of the country are experiencing fewer cases of the virus.
CMS’ recommendations take into account the White House Coronavirus Task Force’s “Opening Up America Again” three-phased approach (White House Plan), which provides guidelines to assist state and local officials in reopening their economies in light of the pandemic. As part of Phase 1 of the White House Plan, CMS’ guidelines outline how facilities in regions with low and stable rates of COVID-19 could begin to reopen and provide non-emergent, non-COVID-19 healthcare services to patients in an effort to meet ongoing healthcare needs (e.g., chronic disease care, elective procedural care and preventative care) that are currently being deferred. Accordingly, states or regions that have passed the State or Regional Gating Criteria under the White House Plan (e.g., downward trajectory of COVID-19-like cases within a 14-day period and robust testing programs in place for at-risk healthcare workers) may utilize these new recommendations when determining whether to reopen facilities and provide non-emergent, non-COVID-19 healthcare services.
Healthcare providers should consider the following when reviewing CMS’ new recommendations, which provide welcome flexibility to restart “non-essential” procedures.
- Coordinate, Prepare and Prioritize Before Proceeding With Non-Emergent, Non-COVID-19 Procedures. Before reopening and providing elective procedures, CMS strongly encourages providers to undertake careful planning and coordination with state and local public health officials to ensure, among other things, adequate facilities, testing and supplies will be available, as well as a clinically appropriate workforce across all phases of care (e.g., clinicians, nurses, anesthesia, pharmacy, imaging, pathology and post-acute care). Providers and local authorities should also ensure they maintain the resources necessary to quickly respond to a surge in COVID-19 cases should such arise in their community as they begin to again provide elective procedures. While acknowledging that many other preventative services may be highly necessary, CMS urges providers to prioritize surgical/procedural care and high-complexity chronic disease management.
- Aim to Establish “Non-COVID Care” Zones. To reduce exposure and transmission of COVID-19, CMS urges providers who intend to reopen and provide non-emergent, non-COVID-19 services to establish “Non-COVID Care” (NCC) zones within their facilities. To the extent possible, these NCC zones should be separate from other facilities (e.g., separate building, designated rooms or entrances) and staff working in the NCC zone should not rotate into COVID-19 care zones in order to prevent crossover of patients being treated for the virus. In light of these recommendations, providers may consider notifying patients of the NCC zones and protocol in advance of their arrival to best mitigate potential spread. Such protocol should include screening all patients and staff for potential COVID-19 symptoms before they enter the NCC zone.
- Encourage Use of Personal Protective Equipment. CMS encourages providers to adhere to the Centers for Disease Control and Prevention’s (CDC) recommendations for universal source control, to wear surgical face masks at all times, and to make every effort to conserve personal protective equipment (PPE). To the extent procedures on the mucous membrane will be undertaken, providers and staff should utilize appropriate respiratory protection (e.g., N95 masks) and face shields, as these procedures create heightened risk for exposure and spread of COVID-19. Providers may also consider requesting that patients utilize a face covering upon arrival at the facility for the non-emergent procedure. Before reopening, providers should ensure they have an adequate supply of the necessary and appropriate PPE needed to perform the procedures that will be rendered. CMS also suggests providers put in place thorough sanitation protocols and appropriate COVID-19 symptom screening and patient/staff testing, when adequate capability is established.
- Continue to Monitor Government (Including State) Guidance on Non-Essential Procedures. These CMS recommendations regarding the provision of non-emergent care are the first in a series of recommendations that CMS intends to issue. Accordingly, new and additional guidance from CMS is likely forthcoming in the near future. In issuing these recommendations, CMS expressly notes that the new guidelines for providing non-essential procedures are not intended to be implemented in every region at this time; rather, governors and local leaders must ultimately make decisions on whether the recommendations are appropriate in their communities, with each provider making the ultimate decision about patient care. CMS also recommends that healthcare facilities and providers in areas that still face a heightened number of COVID –19 cases continue to follow the guidance issued by CMS last month. As outlined in a prior McGuireWoods alert, many states have already issued their own guidance regarding the provision of elective procedures, taking into account the historic CMS guidance. These state mandates likely will be revisited (and, in some cases lifted) in light of changing community needs in facing the COVID-19 pandemic, the new CMS recommendations and the White House Plan.
- Continue Utilizing Telehealth Services to the Maximum Extent Possible. Although the CMS recommendations acknowledge that providers in regions with a low and stable incidence of COVID-19 need the flexibility to restart clinically necessary care for patients with non-COVID-19 needs, maximum use of all telehealth modalities is still strongly encouraged. As discussed in a prior alert, the federal government has expanded the availability of telehealth services in light of the COVID-19 pandemic, and states have followed suit with similar actions.
- Note That These Are Non-Binding Recommendations. Similar to the prior guidance issued, CMS’ recommendations are not, at this time, binding. Rather, CMS intends these recommendations to serve as a guidepost and assist providers when determining how best to reinstitute the provision of non-emergent, non-COVID-19 healthcare in regions with low incidence of the virus. As stated above, CMS very likely will release additional recommendations regarding the provision of non-emergent care in the near future. CMS’ guidance joins that of other organizations, as in this jointly issued statement by the American Society of Anesthesiologists and other organizations, in calling for providers not to perform elective surgeries before their community sees a sustained reduction in the rate of new COVID-19 cases for at least 14 days and only if the community also has appropriate facilities and PPE. Providers should review the CMS guidelines in collaboration with state and local public health authorities to determine whether the provision of non-emergent, non-COVID-19 care is appropriate in their community.
Please contact the authors for additional information regarding these new CMS recommendations and their impact on reinstituting the provision of non-elective procedures. McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.
In a series of video alerts, McGuireWoods’ healthcare lawyers address issues providers face and overcoming COVID-19 challenges.