How to Handle Elective Surgeries and Procedures During the COVID-19 Pandemic - McDermott Will & Emery

How to Handle Elective Surgeries and Procedures During the COVID-19 Pandemic

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Overview


Government officials and hospital, medical and dental associations have issued guidance and statements regarding whether to continue performing elective surgeries in light of the Coronavirus (COVID-19) pandemic. Some authorities have recommended ceasing all elective surgeries until the transmission of COVID-19 has slowed. Others believe that the decision should be made on a case-by-case basis, taking into account a patient’s prognosis without the procedure.

 

In Depth


UPDATED MARCH 22, 2020

Timeline of Recommendations Regarding Elective Surgeries and Procedures

On March 1, 2020, the Centers for Disease Control and Prevention (CDC) issued Interim Guidance for Healthcare Facilities: Preparing for Community Transmission of COVID-19 in the United States. The CDC recommended that inpatient facilities reschedule elective surgeries as necessary and shift elective urgent inpatient diagnostic and surgical procedures to outpatient settings, when feasible.

On March 13, 2020, the American College of Surgeons (ACS) released COVID-19: Recommendations for Management of Elective Surgical Procedures, and recommended minimizing, postponing or canceling electively scheduled surgeries and invasive procedures. ACS stated: “Each hospital, health system, and surgeon should thoughtfully review all scheduled elective procedures with a plan to minimize, postpone, or cancel electively scheduled operations, endoscopies, or other invasive procedures until we have passed the predicted inflection point in the exposure graph and can be confident that our health care infrastructure can support a potentially rapid and overwhelming uptick in critical patient care needs.”

On March 14, 2020, US Surgeon General Jerome Adams, MD, retweeted ACS’s guidance, urging hospital and healthcare systems to “please consider stopping elective procedures until we can” flatten the curve. The surgeon general explained that each elective surgery performed potentially brings COVID-19 to these facilities, depletes personal protective equipment (e.g., gloves, masks, goggles, gowns) stock, and taxes personnel who may be needed for COVID-19 response.

On March 15, 2020, in response to these recommendations, the American Hospital Association, Association of American Medical Colleges, Children’s Hospital Association and Federation of American Hospitals sent a letter to the surgeon general requesting that he clarify his comments by recognizing the gradients of elective surgeries and offering guidance on how to classify the various levels of necessary care. The associations explained that “elective” simply means that “a procedure is scheduled rather than a response to an emergency,” and could therefore include, for example, replacement of a faulty heart valve, removal of a serious cancerous tumor or a pediatric hernia repair. The associations stated that the delay or cancellation of these procedures often rapidly worsens the patient’s condition, potentially turning it into a life-threatening condition and making the patient more vulnerable to COVID-19. The associations recommended that physicians determine what is in the patient’s best interest and make a case-by-case evaluation of many factors, such as the current and projected COVID-19 cases in the facility and in the surrounding area, and the urgency of the procedure.

On March 16, 2020:

  • The Ambulatory Surgery Center Association released a position statement regarding its stance on elective surgeries during the COVID-19 pandemic in which it stated that “ASCs can continue to provide safe surgical care for patients whose condition cannot wait until the health care system returns to normal operations.”
  • The American Dental Association issued a news alert recommending that dentists nationwide postpone elective procedures for the next three weeks.
  • The American Academy of Ophthalmology issued a news alert supporting ACS’s recommendation to minimize, postpone or cancel elective surgeries while recognizing that the timing may vary by community and disease indication.

In a March 17, 2020, White House Coronavirus Task Force press briefing, White House COVID-19 response coordinator Dr. Deborah Birx recommended that hospitals and dentists cancel all elective surgeries over the next two weeks in order to free up hospital beds and space. The task force has stated that its recommendations are not mandatory.

In a March 17, 2020, White House Coronavirus Task Force press briefing, White House COVID-19 response coordinator Dr. Deborah Birx recommended that hospitals and dentists cancel all elective surgeries over the next two weeks in order to free up hospital beds and space. The task force has stated that its recommendations are not mandatory.

On March 18, 2020, the Centers for Medicare & Medicaid Services (CMS) released recommendations to conserve personal protective equipment, beds and ventilators and limit the exposure of patients and staff to COVID-19. CMS recommended that all non-essential dental exams and procedures be postponed until further notice. CMS also recommended postponing or canceling non-essential adult elective surgery and medical and surgical procedures, and making case-by-case evaluations on whether a planned surgery should proceed. CMS suggested considering a number of factors, such as the patient’s health and age and the urgency of the procedure. CMS also provided examples of surgeries and procedures that would be appropriate to delay and others that would be permissible to continue to perform.

On March 19, 2020, the ASCA released new guidance for ambulatory surgery centers (ASCs) with respect to what might constitute a “necessary surgery” during the COVID-19 pandemic. The guidance states that “[a] surgery may be deemed urgent and necessary if the treating physician decides that a months-long delay would increase the likelihood of significantly worse morbidity or prognosis for the patient,” and provides examples of cases that might still need to proceed with surgery during the COVID-19 pandemic.

The ASCA noted that ASCs should be prepared in case hospitals need to shift necessary surgeries to ASCs or ASC resources otherwise become necessary to support community efforts to address the COVID-19 pandemic. The ASCA cautioned that the effects of the COVID-19 pandemic could create situations in which ASCs must temporarily suspend services, such as when an individual who has been in an ASC facility is suspected or diagnosed with COVID-19, or when a significant shortage of personal protective equipment prevents the safe practice of surgical cases. In addition to providing this guidance, the ASCA is tracking state activity affecting ASCs.

On March 20, 2020, the ASCA released a message to ASCs instructing them to strictly adhere to federal and state guidance to immediately postpone all surgeries that can be delayed for six to eight weeks and to use personal protective equipment sparsely and wisely. The ASCA encouraged all ASCs to communicate with their local hospitals to ensure a coordinated response in the best interest of their communities.

Hospital and Local Leader Response

In light of these recommendations, several hospitals and health systems have announced that they will postpone elective surgeries and procedures, although the timeframes for postponement vary. Other hospitals are making decisions on a case-by-case basis.

Additionally, several state governors and public health departments have recommended that elective surgeries and procedures be postponed or cancelled:

  • On March 15, 2020, Massachusetts Department of Public Health (DPH) Commissioner Monica Bharel signed an order directing all hospitals and ambulatory surgical centers to implement procedures published by the DPH regarding the scheduling, cancelation and performance of non-essential, elective invasive procedures until the state of emergency is terminated. DPH recommended that providers at each hospital or ambulatory surgical center use their clinical judgment on a case-by-case basis for any invasive procedures necessary to preserve the patient’s life and health. This recommendation does not apply to the cancellation or delay of life-sustaining care. DPH defined non-essential, elective invasive procedures as procedures that are scheduled in advance because they do not involve a medical emergency (terminating a pregnancy is not considered a non-essential, elective invasive procedure for the purpose of this guidance). However, the ultimate decision should be based on clinical judgment by the caring physician. The DPH procedures list examples of non-essential, elective invasive procedures.
  • On March 16, 2020, New York Mayor Bill De Blasio signed an executive order that directed all hospitals and ambulatory surgery centers in New York City to cancel or postpone all elective surgeries that may be cancelled or postponed based on patient risk starting March 20, 2020. The goal is to make additional hospital beds available so that the health system is not overwhelmed during a potential spike in COVID-19 cases, while also limiting exposure of healthy individuals to COVID-19.
  • On March 17, 2020, Director of the Ohio Department of Health, Amy Acton, issued a director’s order stating that all non-essential or elective surgeries and procedures that utilize PPE should not be conducted. Acton defined a non-essential surgery as a procedure that can be delayed without undue risk to the current or future health of a patient.
  • On March 19, 2020;
    • Alabama Governor Kay Ivey issued a statement that “all elective dental and medical procedures shall be delayed, effective immediately.”
    • Colorado Governor Jared Polis issued an executive order suspending, effective March 23, 2020, all voluntary or elective surgeries or procedures, whether medical, dental or veterinary, until April 14, 2020, unless extended further. The order states that a voluntary or elective surgery or procedure means that the surgery can be delayed for a minimum of three months without undue risk to the current or future health of the patient as determined by the guidelines developed by the hospital, surgical center or other treating medical facility. The order sets forth four situations in which a surgery or procedure may proceed. Rural and critical access hospitals are exempt from this order but are strongly advised to comply on a voluntary basis.
    • Washington Governor Jay Inslee signed a proclamation restricting non-urgent medical and dental procedures, effective immediately until May 18, 2020. The proclamation prohibits “all hospitals; ambulatory surgical facilities; and dental, orthodontic and endodontic offices in Washington state from providing healthcare services, procedures and surgeries that, if delayed, are not anticipated to cause harm to the patient within the next three months, with exceptions and as provided below. This does not include outpatient visits delivered in hospital-based clinics.” The proclamation provides a list of examples of procedures to delay. The order does not apply to the full suite of family planning services and procedures or to treatment for patients with emergency/urgent needs. Hospitals and ambulatory surgical facilities may perform any surgery that if delayed or canceled would result in the patient’s condition worsening.
  • On March 20, 2020:
    • Florida Governor Ron DeSantis signed an executive order, which, effective immediately, prohibited the provision of any “medically unnecessary, non-urgent or non-emergency procedure or surgery which, if delayed, does not place a patient’s immediate health, safety, or wellbeing at risk, or will, if delayed, not contribute to the worsening of a serious or life-threatening medical condition.” The order applies to all hospitals; ambulatory surgical centers; office surgery centers; dental, orthodontic and endodontic offices; and other healthcare practitioners’ offices in Florida. The order incorporates much of CMS’s March 18 recommendations regarding the limitation of all non-essential surgeries and procedures. The order will remain in effect until the expiration of the governor’s prior order declaring a state of emergency for Florida due to the COVID-19 outbreak.
    • Michigan Governor Gretchen Whitmer signed an executive order requiring all hospitals, freestanding surgical outpatient facilities, dental facilities and state-operated outpatient facilities to implement a plan to temporarily postpone all non-essential procedures by March 21, 2020, and continuing while the state of emergency declared is in effect. The order defines “non-essential procedure” as a medical or dental procedure that is not necessary to address a medical emergency or to preserve the health and safety of a patient, as determined by a licensed medical provider. The order includes a list of medical procedures and dental procedures that must be postponed and those that may continue to be performed. The order specifies that emergency or trauma-related procedures where postponement would significantly affect the health, safety and welfare of the patient must not be postponed.
    • Vermont Governor Phil Scott signed an executive order directing all clinicians to expedite postponement of all non-essential adult elective surgery and medical and surgical procedures, including all dental procedures, in the safest and most expedient way possible, effective immediately until April 15, 2020, unless extended. The order states that case-by-case evaluations on whether a planned surgery or procedure should proceed will be made by clinicians, and lists several factors for them to consider.

Considerations

Elective surgeries and procedures often make up a significant percentage of healthcare provider revenue. Postponing these procedures will undoubtedly have significant financial ramifications for virtually all providers, from hospitals and health systems to physician and dental practices. While the CMS recommendations are not yet mandatory, a number of states have taken them to the next level by mandating that elective procedures be put on hold to try to preserve limited resources within the healthcare system and mitigate community spread of COVID-19. Other states will likely continue to follow suit, as the COVID-19 pandemic stresses the healthcare systems in additional states throughout the country. These orders are necessarily being put together hastily against the backdrop of a pandemic, resulting in key questions for which there is little available guidance to follow. For instance, where exactly is the line drawn for what constitutes non-essential procedures, and when does a procedure become urgent? Providers are left to navigate this uncertainty and make judgment calls that will affect their patients and their already-imperiled bottom lines. Another consideration worth noting is that, to the extent non-hospital providers such as physician practices begin to limit their hours and accessibility due to government recommendations and dwindling demand for non-essential procedures, additional stress could be placed on hospitals as patients’ options for care become more limited.

Cancelled elective surgeries may also affect participation in payment models sponsored by Medicare and other payors, which may cause further financial stress. Hundreds of institutions across the country participate in inpatient episode-of-care models such as the Comprehensive Care for Joint Replacement Model or the Advanced Bundled Payments for Care Improvement Model. These episode-based payment models reward institutions for maintaining costs below set target prices and maintaining or improving quality of care. Disruptions in a participant’s ability to provide these services, or changes to the typical resources necessary to provide these services, may not only affect performance in the current model year, but may also impact future years because of the use of historical claims data to set target prices for episodes in future years.

In addition to loss of revenues, many providers, particularly hospitals and health systems, face increased costs associated with the COVID-19 pandemic, including locating and purchasing additional—and often more expensive—supplies and equipment, higher staffing levels, additional paid sick leave and paid time off for employees, enhanced training on telehealth, and setting up additional separate testing sites for COVID-19, among other extraordinary expenses. Hospitals treating patients with COVID-19 also face uncertain reimbursement. Moreover, for all providers, it is unclear when cancelled surgeries could be rescheduled, as the United States is still working to flatten the curve of the pandemic. We do not yet know when the curve will begin to flatten, reflecting containment of the virus. These steps, while necessary from a public health perspective, leave providers in a tenuous position.

As providers find themselves in the crosshairs of the COVID-19 crisis, they may simultaneously find themselves in a challenging fiscal situation with continued uncertainty ahead. As law and policy makers seek to provide economic and regulatory relief to affected industries, it will be important for hospitals and other providers to document the impact of COVID-19 on their operations and their bottom line, and to communicate this information and any needed regulatory relief to their elected officials, their trade and professional associations, and their government relations advisors. Providers should also continue to evaluate their options and obligations with respect to how they conduct themselves and address their patients’ needs as new guidance and additional orders are issued as the COVID-19 crisis evolves in real time.

Shelia Madhani of McDermott+Consulting also contributed to this On the Subject.