In a previous Health Law Insider blog post, Stoel Rives’ health care team discussed the prohibition on elective procedures promulgated by Oregon and Washington in an effort to conserve the states’ supply of Personal Protective Equipment (“PPE”) and manage provider treatment capacity to ensure adequate resources were available to combat COVID-19. Recently, Oregon and Washington issued guidance permitting providers to gradually restart the provision of elective and non-emergent procedures. As discussed below, Washington also released interpretive guidance to help providers determine how to assess “harm” to the patient that would help determine which procedures are urgent such that they are permitted under the “critical care phase” described in Governor Inslee’s Proclamation 20-24.1.
Additionally, Minnesota recently eased its prohibitions on non-urgent and elective procedures. For information regarding Minnesota’s order, please refer to our earlier client alert.
Oregon’s requirements for resumption of elective and non-emergent procedures are onerous and differ based on the provider type. Prior to resuming elective and non-emergent procedures, hospitals and ambulatory surgical centers (“ASC”), must:
- Ensure that they have adequate bed and workforce capacity to “accommodate an increase in COVID-19 hospitalizations in addition to increased post-procedure hospitalizations.” Specifically, hospital bed (i.e., ICU, step-down, and medical/surgical beds) availability in the region must be maintained at or below 20% and providers must have sufficient capacity to treat all hospitalized patients “without resorting to crises standard of care”;
- Attest that they are maintaining a 30-day PPE supply on hand (two-week supply and an “open supply chain” is sufficient for “small facilities”);
- Be able to obtain “sustained PPE supply” without the triggering PPE-conserving measures;
- Hospitals must provide a daily PPE supplies report to the Oregon Health Authority’s hospital capacity web system;
- Have adequate access to COVID-19 testing capacity that provides results within two days (four days for smaller facilities) and consider testing patients before performing non-emergent or elective procedures;
- Have strict infection control and visitation policies in place; and
- Have sufficient resources for peri-operative care (e.g., pre- and post-operative provider visits; lab, radiology, and pathology services; and other ancillary services).
Once hospitals and ASCs begin performing elective and non-emergent procedures, they must conduct bi-weekly compliance review of all criteria. In addition, the volume of non-emergent and elective procedures must be limited to 50% of pre-COVID volumes. To maintain and eventually expand the volume, hospitals and ASCs must continue to meet all criteria discussed above. Providers must adopt a plan to cease all non-emergent and elective procedures if there is a surge in COVID-19 cases or if the criteria discussed above cannot be satisfied. Cases must be prioritized based on adverse medical outcome and balancing risk versus benefits for patients in higher-risk groups (e.g., patients over the age of 60, patients with compromised immune systems or lung/heart dysfunction). Finally, hospitals and ASCs must continue to consider delaying non-emergent and elective procedures that require certain resources (e.g., transfusion, pharmaceuticals in short supply, ICU admission, transfer to skilled nursing facility or inpatient rehab).
Prior to resuming elective and non-emergent procedures, medical and dental offices must have sufficient PPE supplies to support their workforce for two weeks without triggering emergency conservation measures. Strict infection control policies recommended by the Centers for Disease Control and Prevention (“CDC”) must be followed. A bi-weekly review must be conducted to ensure compliance with all applicable requirements. Medical and dental offices must also:
- Decrease volumes to maximize social distancing, implement social distancing measures in waiting rooms and other office areas, and use physical barriers during patient care, if possible;
- Adopt a plan to reduce or stop non-emergent and elective procedures if there is a surge in COVID-19 cases;
- To maintain or grow procedure volumes, must ensure they have adequate PPE supplies and can comply with infection control policies;
- Prioritize procedures based on adverse health outcome and considering the risks versus benefits for patients in high-risk groups; and
- Utilize enhanced screening (e.g., pre-screen via telehealth if possible; screen all patients for COVID-19 symptoms, such as fever; and test all patients for COVID-19 before conducting the procedure if adequate testing is available).
We suspect it may be challenging for providers to ensure they meet the minimum threshold for PPE supply amounts required by Oregon’s plan before non-emergent and elective procedures can be performed. Specifically, it may be challenging for hospitals and ASCs to obtain a “sustained PPE supply” given the supply chain disruptions and shortages. Similarly, medical and dental offices may find it challenging to procure and maintain a consistent two weeks’ worth of PPE supply.
Further, due to supply chain disruptions and overwhelmed testing facilities, providers (particularly smaller facilities) may find it difficult to ensure they are receiving COVID-19 test results within the prescribed time periods discussed above. These mandatory thresholds may delay the providers’ ability to resume non-urgent and elective procedures. Thus, providers should first assess whether they can fulfill the PPE and testing thresholds before expending resources on resumption of non-emergent and elective procedures.
Additionally, as discussed above, providers must be prepared to reduce or completely cease elective and non-emergent procedures if there is a “surge” or “resurgence” in COVID-19 cases. However, Oregon’s guidance does not define “surge” or “resurgence,” thus it is unclear what threshold number or percentage of increase in cases would trigger the duty to stop or reduce the procedures. While Oregon has provided detailed guidance for hospitals, ASCs, and medical/dental offices and other health care settings, clarity and perhaps some flexibility on certain requirements is needed to help ensure providers’ resumption of elective and non-emergent procedures is not too onerous and is sustainable.
Washington’s guidance relaxing its prohibition on elective and non-urgent procedures is not as extensive and detailed as Oregon’s guidance. Specifically, Washington has not released guidance specific to provider types. Pursuant to Governor Inslee’s Proclamation 20-24.1, provision of “non-urgent health care and dental services, procedures, and surgeries” is permissible as long as providers implement the following measures:
- “Exercise clinical judgment to determine the need to deliver a health care service”;
- Continuously monitor whether they have adequate resources (e.g., ventilators, beds, PPE, blood/blood products, pharmaceuticals, and trained staff, etc.) to combat a surge of COVID-19 cases;
- Comply with Department of Health’s PPE conservation guidance;
- Review and revise infection prevention policies and procedures;
- Develop and implement a formal employee feedback process regarding the care delivery process, PPE, and technology availability related to expansion of care;
- Use telemedicine when appropriate;
- Prior to or immediately upon entering the provider’s facility, providers must screen patients, visitors, and staff for fever and ask persons to self-report other COVID-19 symptoms;
- Develop and implement pre-procedure COVID-19 testing protocols;
- Implement non-punitive sick leave policies in compliance with CDC return-to-work guidance;
- Post signage encouraging frequent hand washing and sanitizer use, avoiding face touching, and practicing cough etiquette;
- Maintain social distancing for patient scheduling (e.g., space out appointments), check-in processes, and movement within the provider facility. Specifically, ensure that persons maintain a distance of six feet or greater in waiting rooms and patient care areas;
- Allow only those visitors who are essential for patient’s well-being and care;
- Require visitors and ambulatory patients (who are able and if consistent with care being received) to wear face coverings while in the facility;
- Frequently clean and disinfect high-touch surfaces using EPA-registered disinfectant;
- Implement strategies to address employee exposure to COVID-19 patients, who are symptomatic, or ill (e.g., requiring employees to stay at home when sick, requiring timely notification of employees with potential exposure, and testing symptomatic employees);
- In compliance with CDC cleaning guidelines, deep clean facility after provider receives reports of an employee with suspected or confirmed COVID-19 infection;
- Educate patients about COVID-19 in a language the patients best understand; and
- Comply with Governor Inslee’s Proclamation 20-46 regarding high-risk employees’ rights.
In addition to complying with the requirements above, each provider (including “health care, dental or dental specialty facility, practice or practitioner”) must develop an “expansion/contraction of care plan” (“Plan”) consistent with the COVID-19 assessments prepared by local health jurisdictions and the providers’ clinical and operational capacities. The Plan must have three phases:
- Conventional care phase (all appropriate clinical care is permissible);
- Contingency care phase (all appropriate clinical care is permissible as long as provider has “sufficient” PPE access, and for hospitals, “surge capacity is at least 20%”); and
- Crisis care phase (all emergent and urgent care; elective care that cannot be postponed more than 90 days based on the clinician’s judgment of the “harm” to the patient if the procedure was delayed; and family planning services and procedures, newborn care, infant/pediatric vaccinations, and other preventative care (e.g., flu vaccines) is permissible).
To assess “harm” under the crisis care phase and while performing diagnostic imaging, procedures, or testing, providers must refer to Governor Inslee’s interpretive guidance, which provides a laundry list of factors that providers should consider while assessing whether delaying a procedure will cause “harm” such that the procedure is necessary and must be performed without delay. In assessing “harm,” providers should consider, the (i) expected advancement of the disease; (ii) possibility that delay may necessitate a more complex surgery or treatment in the future; (iii) continuing or worsening severe pain; (iv) whether leaving the condition untreated could render the patient more susceptible to COVID-19, etc. A complete list of factors can be found here.
Washington’s order leaves several substantive questions unanswered. Specifically, the order does not expressly state circumstances that would trigger the conventional, contingency, or crisis care phases. It is unclear at which point the providers must transition from one phase to another. Like Oregon, Washington does not define what it considers to be a “surge” in cases that may require providers to stop perfuming non-urgent and elective procedures by transitioning from one phase to another (e.g., from conventional care phase to a crisis care phase). Additionally, it is further unclear what constitutes “sufficient” PPE access under the contingency care phase.
While providers are required to comply with certain PPE conservation measures, unlike Oregon, Washington does not mandate that minimum PPE supply should be maintained (e.g., seven days of PPE supply) to perform non-urgent and elective procedures. While providers have more flexibility, the lack of rigid guidelines regarding minimum PPE amounts make it challenging for providers to conduct risk assessment regarding what the state will deem to be insufficient PPE supply requiring transitioning from one phase to another. For example, is having one week’s worth of PPE supply on hand sufficient to stay in the conventional care phase? Or is one week’s worth of PPE supply inadequate and providers must transition to the contingency care phase?
Providers are required to “continuously monitor” availability of certain resources (e.g., ventilators, beds, PPE, blood/blood products, pharmaceuticals, trained staff, etc.) to combat a surge of COVID-19 cases. We suspect “continuously monitoring” may be onerous and that certain providers may struggle to comply. Further, the guidance does not offer specifics as to the minimum level of resources that must be maintained to be adequately equipped for a surge (e.g., do providers need to ensure that they have 20% or 30% bed capacity that can be dedicated to COVID-19 patients in case of a surge?).
Given that violating Washington’s order may constitute a gross misdemeanor, it is concerning that so many questions remain unanswered. We anticipate that more guidance is forthcoming that will help answer these and other questions, so that providers can be better prepared to resume non-urgent and elective procedures, and respond to a surge in COVID-19 cases.