June 2020, Volume XXXIV, Number 3
Defining what is “essential”
rior to Gov. Tim Walz’s May 5 Emergency Executive Order (EO) 20-51 to “open up” elective surgery procedures across the state, health care centers had struggled to interpret what had been temporarily banned as “elective” under his previous orders in early March. Those EOs had been intended to conserve supplies of personal protective equipment (PPE), respirators, and anesthesia equipment, and to ensure safety and adequate resources for both physicians and patients, but offered little specific information or guidance. The earlier orders produced confusion among providers—as well as concerns about potential government overreach in defining health care decisions.
The Governor’s EO 20-51 acknowledged that “[n]on-essential or elective procedures are often clinically necessary, for example, to treat chronic pain and conditions or to prevent, cure, or slow the progression of diseases,” and noted that Minnesota had made significant headway in securing PPE, improving testing, and building hospital surge capacity. Citing guidance from public health officials, he ordered that surgical facilities could “reopen,” subject to six requirements (see https://tinyurl.com/mp-order-20-51).
The lessons learned to date could help to ensure that elected officials understand and consider the impacts on patient care, and craft sound decisions that serve both physicians and the public during the current pandemic and in the future.
One practice group’s experience
Mankato Surgery Center is one of many providers across the state that struggled to define “essential.” With ownership split evenly between Mankato Clinic, a multispecialty facility, and the Orthopaedic and Fracture Clinic of Mankato, Mankato Surgery Center provides a safe, low-risk alternative to hospital surgical suites, where patients might have had broader exposure to the coronavirus. Ambulatory Surgery Centers (ASCs) such as ours offer outpatient, same-day procedures that allow hospitals to free up bed space and focus on their potential COVID influx.We could have been fined and charged with a misdemeanor.
The Governor’s earlier orders had included three criteria for essential procedures: “a. Threat to the patient’s life if surgery or procedure is not performed; b. Threat of permanent dysfunction of an extremity or organ system, including teeth and jaws; and c. Risk of metastasis or progression of staging.”
Our Board of Directors and surgeons had questions about what to do with patients that did not fall into category a, b, or c. For example, patients whose pain tolerance did not meet the criteria outlined, or those who needed to be mobile and working with a torn meniscus, did not qualify under this definition. Was this type of patient treatment “essential”?
Under EO 20-03 and the state’s Peace Time Emergency, we could have been fined and charged with a misdemeanor if the procedures we continued to perform were not “essential,” even though we did not know the definition of that term. The order was more robust than we had seen in other states with similar orders. We struggled from March 23 to April 9 to find a definition, all the time striving to balance patient’s surgical needs, business changes, and the daily demands under a changing health care environment.
As we began looking for detailed information and guidance, our first thought was what needed to be done with regard to documentation in the event of a state inspection and risk perspective based on a surgeon’s decision, and how we would “defend” cases we had scheduled as essential. The surgery center board ultimately decided to accept our surgeons’ medical judgement in determining which cases fell into the Governor’s new order. “Essential only” had been described as loss of limb, organ failure, or permanent nerve damage, but our center’s orthopaedic owners decided to have a group of physicians review each surgery case to determine if it was necessary. That process assisted in the defending of “essential” cases to be allowed during the Governor’s order.
Speaking as the center’s administrator, I believe that this approach represented good risk coverage in the event we are audited in the future by the state during a retrospective COVID-19 review. The multispecialty clinic and the orthopaedic clinic also reviewed essential cases with some of the specialty associations, including the Association of Ophthalmology. On March 18, they had already published what they considered to be “urgent and non-urgent” cases. We looked for each specialty to do the same until we started to see information in the surgery centers on what they were doing, to allow for a comparison with industry standards.
Collaborating with outside resources
After learning that some ASCs had closed sites and others had slowed cases, as we did, we decided to collaborate with the Minnesota Ambulatory Surgery Center Association (MNASCA). By collaborating with this association, we believed we could reach Gov. Walz to explain our positions and concerns about defining “essential cases only,” and could send a united ASC message.
The initial MNASCA contact was a letter to Gov. Walz’s office, followed by an in-person visit with the Governor’s staff, in which we explained our PPE and ventilator usage and offered to assist potentially strained hospital systems. We also explained the differences between ASCs and hospitals, which include separate PPE and ventilator needs. Mankato Surgery Center does not have the same supplies required in the hospital or among COVID-19 front-line workers. We have special packs for specialties, with all our supplies in a surgical pack, along with a few surgical gowns outside of the pre-made surgical packs. We have our own glove supply and we use surgical masks on hand, and did not intend to ask for additional supplies.
Tom Poul, MNASCA’s legal legislative counsel, and MNASCA President Tom Stevens initiated weekly calls with their members, and invited the Minnesota Department of Health (MDH) team to collectively hear from association members who had been affected by the “shut down” order. A number of ASC administrators have been part of these ongoing calls to help the ASC members navigate through the perils of the pandemic, and are looking to both influence and to assist in changes to impact any future MDH or Governor’s directives. Following these contacts—which also included metro-area surgery centers—the Governor’s office gave MNASCA the option to follow less restrictive MDH guidelines for surgery until Gov. Walz could make an announcement to resume elective cases.
In the literature
On April 9, the Journal of the American College of Surgeons published an article outlining a stratification system intended to help surgeons determine when to proceed with medically necessary operations. This Medically Necessary Time-Sensitive Prioritization (MeNTS) tool was developed to define necessary surgeries and to reduce the burden on the health system. In addition, on April 17, four medical associations issued a “Joint Statement: Roadmap for Resuming Elective Surgery after COVID-19 Pandemic.”
Both of these resources helped validate the choices we had made previously to remain open as a relatively low-risk Covid-19 facility option for patients. It is an ongoing balancing act for our board to feel confident we are making choices for the best interest of patients and employees. Outside resources to “hang our hat on” is always to preferable to paving our own way.
We must ensure that elected officials understand the impact of their decisions.
Feedback, concerns, and responses
Some of our Board members and surgeons believed that the restrictive order could harm patients who did not fit the Governor’s profile of “loss of limb, organ or cause permanent nerve damage.” In addition, they were concerned about patients in constant pain, as well as essential workers who are in need of a shoulder repair or knee surgery. Those types of patients just fell out of the executive order into a holding pattern.
Jesse Botker, MD, FAAOS, who practices at The Orthopaedic and Fracture Clinic of Mankato, said this about the order’s directives:
“I would say that the ban is going to have down the road effects due to delays in care such as higher opioid use which may lead to dependence, increased disease progression that could lead to decreased function and loss of work. Surgery centers are ideal spots to allow patients to receive much needed procedures in an environment that can reduce COVID transmission risk.”
Throughout this period, physicians also struggled to determine how to serve patients who relied on opioids to manage chronic pain that fell outside of the order’s description. The solution should not have been to prescribe additional pain medications to carry them over until an unknown date. We felt as a surgical center that we could put new practices in place with what we knew at the time, to create a relatively low COVID-19 symptomatic facility to remain open as part of the solution.
In the wake of the EO to prioritize surgical cases, we have put in place new processes, policies, and procedures based on guidance from the CDC and MDH. These include mask requirements for patients and staff, COVID swab testing or no COVID testing for patients and staff, airborne precautions with N95 masks if needed, and recommendations for extended PPE use. The goal is to increase patient service under a systematic approach. We are prioritizing patients that have been waiting or taken off the surgery schedule for more than a month. The surgeons decide which patients to put in the new surgical line-up. We inform all patients on these COVID-19 issues, and have explored changes in telemedicine services, developing new policy and payment services.
Legislators and policymakers should understand what ambulatory surgery centers are and how they can play a role in any future pandemic. Some ASCs in the metro area are affiliated with a hospital system and had reviewed their centers to see what space was available for use if ventilator patient overflow options made sense, and to use the center if space was needed.
We are not over the pandemic yet, but lessons learned to date could help us assess what went well and what needs more work in the future. During this pandemic, some providers sought approval to sterilize and reuse N95 masks. The FDA moved quickly on approving some sterilizing units to re-sterilize N95 masks and to help facilities slow the rapid depletion of PPE supplies. While rapidly approving equipment or products may produce unexpected consequences in the future, this is one example of public officials responding quickly.
The policies unfolding now during the pandemic—both in government and within health care organizations—have and will most certainly affect future policy in the face of continuous changes. Policymaking is a moving target. Mankato Surgery Center will continue to follow guidelines from the CDC and other specialty resources to adapt to changing circumstances.
As we move forward, we must ensure that elected officials understand the impact of their decisions on physicians and patients, ensure physician autonomy, and recognize the unique needs of patients across the state.
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