Loosening Restrictions on Elective Surgery and Procedures – FAQs on Updated CMS, Administration and Association Guidance - McDermott Will & Emery

Loosening Restrictions on Elective Surgery and Procedures – FAQs on Updated CMS, Administration and Association Guidance





As the United States came to grips with the far-reaching impact of the Coronavirus (COVID-19) pandemic in March 2020, many state governments put in place executive orders or other public health decrees (collectively, orders) that significantly limited the performance of “elective” (i.e., scheduled, non-emergent) treatments and procedures. In addition, the Centers for Medicare and Medicaid Services (CMS) released guidance on March 18, 2020, and again on April 7, 2020, establishing a tiered approach to restricting elective services, treatments and procedures.

Taken together with the state orders, the CMS elective procedure guidance created a framework that drastically limited the inpatient and outpatient operations of healthcare providers. Healthcare providers felt the effect swiftly, through sharp declines in revenue and non-COVID-19 patient volumes. In an ironic twist, hospitals are currently dealing with overwhelming numbers of patients seeking care for potential or actual COVID-19 infections and shortages of trained emergency room and intensive care staff, while simultaneously initiating staff furloughs in areas such as outpatient surgery and medical clinics, where the orders and CMS elective procedure guidance functioned to curtail operations.

On April 17, 2020, President Donald Trump and Dr. Deborah Birx, the coronavirus response coordinator for the White House Coronavirus Task Force, announced the outlines of the administration’s Guidelines for Opening Up America Again, which set forth a phased plan to guide healthcare systems and facilities as they looked to resume in-person care of non-COVID-19 patients in regions with low and decreasing incidence of COVID-19. That same day, a group comprising the American College of Surgeons, American Society of Anesthesiologists, American Association of periOperative Registered Nurses and the American Hospital Association issued a joint statement regarding their views on the proper criteria and timing to resume elective surgery.

Within 48 hours, on April 19, 2020, CMS issued what were characterized as “Phase I” guidelines for “Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare” (Phase I CMS guidance), detailing CMS’s perspective on when and how healthcare facilities could transition back to providing elective procedures, and eventually preventive care, through a three-phase process. In both the administration’s reopening plan and the Phase I CMS guidance, state-based or regional “gating criteria” establish the circumstances that should be present for each phase to be initiated.

State governments, some of which publicly expressed a desire to scale back COVID-19-related restrictions, have since taken steps to move forward with Phase I-type reopening activities, including revisions to limitations on elective procedures. States taking early steps in this process include Texas, Oklahoma and Alaska. More states are expected to follow suit.

In the same way that many providers struggled to cease these procedures and surgeries, they now struggle with understanding when and how to re-initiate them. The FAQs below address common provider questions as they determine next steps in light of state orders, the administration’s reopening plan, Phase I CMS guidance and the associations’ joint statement.

We will continue to update these FAQs as circumstances warrant.

  1. How will I know when our facility can provide elective procedures and surgeries?
  2. What are the risks if we do not wait?
  3. What factors should we track now to prepare us for “Phase I” in our state?
  4. Can expanded services be provided without social distancing?
  5. How can we provide a “non-COVID-19 care zone” if we have COVID-19 patients elsewhere in our facility?
  6. Will state agencies or CMS certify or approve our “non-COVID-19 care zone” before we can offer elective procedures?
  7. Do we have to test every patient who comes in for an elective procedure or treatment for COVID-19?

How will I know when our facility can provide elective procedures and surgeries?

Providers should be mindful of orders in their state that restrict elective procedures, and should monitor for changes as state governments move to broaden the availability of non-emergent, non-COVID-19 care. Much as the orders in each state may have approached the restrictions differently, the ways in which the orders are changed will also be state-specific. Some states may first focus on outpatient procedures, or procedures outside of hospitals, while others may focus on procedures in hospitals specifically. Providers should consider they types of care they provide, and be prepared to move forward as legally permissible. Our team has developed a tracking tool to assist our clients with understanding this dynamic environment; please contact us for more information.

In addition to tracking shifts in orders, providers must ensure that they are fully prepared to offer elective procedures in the midst of a pandemic, including, without limitation, ensuring stringent infection control processes, the availability of healthy staff, a safe environment and sufficient personal protective equipment (PPE). Both the Phase I CMS guidance and the joint statement provide additional factors for consideration in preparing for ramping up such procedures, as noted below.

What are the risks if we do not wait?

The Phase I CMS guidance, joint statement and administration reopening plan are guidance only, without the force of law. CMS has not linked enrollment status (i.e., threat of survey or other enforcement) or payment to a provider’s performance or non-performance of elective procedures.

The main legal risk to restarting elective procedures lies with the orders in place in a given state, and the potential for state enforcement for violation of the orders. Some states may have the power to impose fines or other penalties for violation of the orders. Our tracking tool includes a summary of these potential fines and penalties. In other states, the immunity granted to healthcare providers and facilities related to COVID-19 may be linked to the cancellation of elective procedures, putting continued application of the immunities in jeopardy.

In addition, providers that choose to provide elective procedures before the state scales back or rescinds its orders may garner negative public reaction and press coverage, as has been the case for a handful of providers around the country to date. Future plaintiffs could also potentially use the provision of procedures without clear legal authorization as part of their claims against providers or facilities.

What factors should we track now to prepare us for “Phase I” in our state?

States may set different thresholds, but based on the administration reopening plan, Phase I CMS guidance and the joint statement, providers should consider factors such as the following, in coordination with state agencies and state guidance, as they seek to provide elective procedures:

  • The rate and leveling of COVID-19 infections and deaths (a “sustained reduction” for 14 days or more is commonly suggested as a benchmark)
  • Provisions and safety measures to be put in place for higher-risk procedures (i.e., procedures that involve the respiratory tract or mucous membranes, or that require intubation)
  • The need for new or enhanced policies, procedures and processes to provide elective procedures in light of what is known (and unknown) about COVID-19 infection and spread
  • “Procedural triage” to identify the priority of certain procedures and the clinical needs of the patients seeking them out, in the context of the providers and facility capabilities as the pandemic continues
  • The availability of resources beyond those needed for surge capacity and day-to-day COVID-19 care elsewhere in a facility, including PPE, workforce (including providers for health screenings), facilities, supplies, testing capacity and post-acute care
  • Mechanisms to preserve/reuse PPE in a clinically acceptable manner
  • Establishing processes for environmental and equipment cleaning that take into account updated guidance from the Centers for Disease Control and Prevention and industry standards for infection control
  • How to methodically “ramp up” procedures in a manner that prioritizes patient and staff safety, and quickly “wind down” operations in case of a surge situation or “second wave” that requires enhanced restrictions.

Can expanded services be provided without social distancing?

Social distancing may be implemented in waiting rooms and other environments related to the provision of care. Limiting or restricting visitors and requiring patients and any visitors to wear masks and practice hand hygiene can be made part of processes around elective procedures. In procedure and operating rooms, providers and patients will be closer together as clinical needs dictate, with the use of appropriate PPE.

How can we provide a “non-COVID-19 care zone” if we have COVID-19 patients elsewhere in our facility?

The guidance advises facilities that plan to undertake elective procedures to establish operations and processes that aim to reduce the risk of COVID-19 exposure and transmission, including establishing separate areas apart from those used to care for COVID-19 patients (such as separate floors, wings or buildings) to limit “crossover” with COVID-19 care areas (each a non-COVID-19 care zone).

The guidance notes that non-COVID-19 care zones require consistent administrative, engineering and operational processes and controls to:

  • Facilitate social distancing (limiting waiting areas/waiting room density and patient volumes)
  • Strictly limit or prohibit visitors (with any visitors subject to screening for COVID-19 symptoms)
  • Ensure thorough cleaning and disinfection consistent with current guidelines for infection control
  • Diligently screen patients and staff (including clinical and non-clinical staff that access the non-COVID-19 care zone) for symptoms of COVID-19, including temperature checks.

Will state agencies or CMS certify or approve our “non-COVID-19 care zone” before we can offer elective procedures?

Currently there is no process in place for CMS approval of non-COVID-19 care zones. Each provider would be responsible for ensuring the safety of the care rendered to patients, regardless of “zone” and whether the procedures provided were emergent or elective. Individual states may enact specific public health or licensing requirements to help safeguard infection control and patient safety as elective procedures begin again in those states.

Do we have to test every patient who comes in for an elective procedure or treatment for COVID-19?

There is currently no regulatory provision that specifically requires pre-procedure testing. However, guidance to date makes clear that all patients should be screened for potential symptoms of COVID-19 prior to elective procedures and prior to entering the non-COVID-19 care zone. Similarly, staff must be routinely screened for potential symptoms to optimize safety and reduce community spread.

Some hospitals and healthcare systems have access to COVID-19 testing through their own laboratories, which could permit pre-procedure testing. Providers who can test will likely choose to do so, to the extent it helps them maintain non-COVID-19 care zones and ensure staff safety. As testing becomes more widely available, testing likely will be recommended for both patients and staff involved in elective procedures and care within a non-COVID-19 care zone.