Across the country, health care providers have struggled during the COVID-19 pandemic in the face of declining revenue and increased expenses.
This financial stress has adversely affected almost all entities within the health care delivery system — large and small, urban and rural, high Medicaid and low Medicaid, academic and community-based.
A number of states have now eased restrictions imposed on elective surgeries and procedures. By one account from late April, 30 states had allowed or announced plans to enable elective surgeries to restart under certain circumstances.
As health care providers turn their attention to resuming elective surgeries and procedures, this entry into the “new normal” must be undertaken with care. Leadership and legal counsel will want to assure that there is a robust interdisciplinary implementation plan that focuses on the core business and mission pillars of patient safety, workforce safety, transparency, and equity in the delivery of care.
Successful development and execution on this implementation plan by health care organizations will benefit from adhering to several key actions:
Establish a Centralized and Interdisciplinary Implementation Team
To successfully re-establish elective surgeries and procedures, and other non-COVID services, a provider should have a centralized and diversified decision-making team that can assign responsibilities, vet issues, and develop an integrated approach. This team should include not only executive and clinical leadership, but also should have representatives from human resources, quality assurance, communications, finance and revenue cycle management, information technology, facilities and physical plant, risk management, compliance and legal.
While the coordinated work of the entire team will be essential, it is important to allow various subject matter experts to take the lead on certain elements of the team’s work. This will not only enhance results but also will mitigate against the “meeting fatigue” that can take hold in health care organizations. For example, the human resources representative might want to coordinate with legal and clinical team members, as well as facilities personnel, around proposed workforce safety strategies. Similarly, quality assurance and patient safety personnel, along with clinical leaders, risk management, legal, and institutional equity, might want to develop proposed patient safety and case prioritization protocols for consideration by the entire team (or by a committee established for the distinct purpose of making prioritization decisions).
Coordinate with the Governing Board
It will be vitally important for executive leadership to communicate these steps to the organization’s governing board. While it may not be the case that the board must approve in advance specific re-opening measures, the board should be promptly and thoroughly informed as to how, why and when elective surgeries and procedures will resume, and should have the chance to ask questions about and test the ramifications of these plans.
If the board has a COVID-19 working group, that may be a good forum for the governance coordination to occur. Otherwise, depending on the size and structure of the board, coordination might take place with the executive committee or the board as a whole. Whatever governing body is selected should have sufficiently diverse perspectives to assess financial, quality, reputational, health care equity, legal compliance and risk issues that may be relevant to the resumption of elective surgeries and procedures.
Review and Incorporate Legal Mandates and Advisory Guidance
Providers must comply with applicable state and local mandates for whether and how to resume elective surgeries and procedures and, in addition, should adhere to Phase I Recommendations issued by the Centers for Medicare & Medicaid Services (CMS)(CMS Phase I Recommendations). Many providers also might find it beneficial to evaluate and follow some or all guidelines issued by non-governmental bodies, such as the “Roadmap for Resuming Elective Surgery after the COVID-19 Pandemic” jointly issued by the American College of Surgeons, the American Hospital Association, the American Society of Anesthesiologists, and the Association of perioperative Registered Nurses (Jointly-Issued Roadmap), and the Local Resumption of Elective Surgery Guidance issued by the American College of Surgeons.
While these requirements, recommendations, and guidelines are important, they also tend to be fairly general in scope and will require facility-specific assessment. Categories to be evaluated by a facility include:
- “Gating criteria” to be met before the resumption of elective surgeries, such as sustained reduction of new COVID-19 symptoms and cases in the relevant geographic area for at least fourteen (14) days; demonstrated adequacy of hospital and ICU beds in the relevant geographic area (ability to treat all hospital patients without crisis care); and availability of robust testing for at-risk health care employees. Coordination with state and local public health officials is recommended.
- A facility-specific determination regarding adequacy of ICU and non-ICU beds, surgical and non-surgical staff, PPE, testing, ventilators, medications, anesthetics, and supplies.
- The Jointly-Issued Roadmap offers specific guidelines around: development of staff and surgical patient testing policies; adequacy of PPE and training on the use and conservation of PPE; establishment of a prioritization policy committee to address case scheduling and prioritization matters such as previously-canceled cases, objective priority scoring, the needs of certain specialties (such as cancer, organ transplants, cardia, trauma), and Operating Room utilization issues; and policies for postponement of surgical scheduling tied to the five phases of surgical care.
- The CMS Phase I Recommendations indicate that providers should: prioritize surgical/procedural care and high-complexity disease management; consider establishing ‘Non-COVID Care” (NCC) zones; establish routine COVID-19 screening procedures for all entering NCC zones; screen all patients for COVID-19 prior to entering the NCC zone; apply PPE use and preservation protocols; routinely screen staff, and limit staff working in NCC zones to those NCC areas; apply facility protocols to enhance the safety of NCC zones and to facilitate social distancing; and generally prohibit visitors, but with patient-level screening of any visitors who are necessary for care.
Assessment of these materials will allow the implementation team to comply with legal requirements, and also will afford it the benefit of thinking by organizations issuing non-binding guidance. These guidelines should be updated periodically, and reliance upon them should be documented. This will have potential risk management and liability mitigation benefits for the provider organization.
For legal counsel, it may be advisable to pay particular attention to the emerging and evolving standard of care for elective surgery and procedures in a COVID-19 era, as it develops and is refined. Within this, it will be important to focus on facility policy around patient informed consent and the exact manner by which surgeries and procedures are being prioritized to assure compliance with legal, ethical and mission standards.
Implement a Thoughtful Communications Plan that Emphasizes Transparency and Safety
Integral to the successful resumption of elective surgeries and procedures is effective internal, patient, and public communication. Does the workforce know what steps are being taken to protect their safety? In turn, do prospective surgery patients know the steps that are being implemented to protect their safety? Are patients and their representatives being offered a more detailed informed consent form and session that assures a true understanding of the benefits and risks of undertaking surgery at this time? Have the surgical informed consent procedures been revised to reflect COVID-19 considerations?
This communications strategy also should extend to external groups. Media coverage for the organization will impact reputation and may have an effect on governmental and non-governmental funding opportunities. Similarly, it may be advisable to keep local, state, and federal elected officials apprised of how the organization is doing and why a safe and responsible resumption of elective surgery and procedures is in the community’s best interest.
Document the Process
The restart of elective surgeries and procedures in the COVID-19 era is unprecedented. As a result, there are not well-established procedures that are accepted as the standard of care or as the preferred manner of operations. In this uncertain climate, the need for an interdisciplinary team that is in close contact with the organization’s governing board, and that applies binding mandates and evaluates non-binding guidance, is compelling. Not only should this team’s guidance be thoughtful and well-communicated, but there should be appropriate documentation of its composition, the steps it took, the external guidance it reviewed, the facts it considered, and the reasons for its decisions. This documentation should be developed in consultation with legal counsel for the organization.
As health care provider organizations resume elective surgeries and procedures in a COVID-19 era, it is important that an interdisciplinary team be formed, with the inclusion of legal counsel, to develop and implement policies governing this action. Each organization should assure that the restart of elective surgeries and procedures is implemented consistent with the core business and mission pillars of patient safety, workforce safety, transparency, and equity in the delivery of care, and in a manner that is legally compliant and sensitive to risk mitigation.
The interdisciplinary team, with the advice of legal counsel, should carefully evaluate external mandates and guidelines, assure appropriate coordination with the organization’s governing board, facilitate the development of an internal and external communications strategy, and document its work. In advising the team and the organization, legal counsel should recognize the lack of a well-established standard of care for resumption of elective procedures in a COVID-19 era, evaluate the fiduciary duties that apply to executive leadership and the governing board, and pay particular attention to areas of potential liability such as adequacy of informed consent, reliance upon external standards and guidelines, and appropriateness of the standards applied to prioritize care delivery.