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For many months, the healthcare world has been significantly affected by the swift and pervasive effects of SARS-CoV-2, which causes COVID-19. The virus has severely affected the delivery of patient care by all providers, including those in hospitals and emergency care settings, who grappled with the response to massive influxes of COVID-19 patients, and those in office practices forced to discontinue non-essential services for a period of time due to public health order restrictions. This public health emergency has created lingering uncertainty in determining how to provide healthcare in this new normal while also ensuring workforce and patient safety.
As we head into natural disaster and influenza season, providers should focus on several key practices to create a safer, more stable environment while remaining vigilant for a COVID-19 resurgence.
Employee Considerations
OSHA Requirements
The Occupational Safety and Health Act (OSHA) General Duty Clause requires employers furnish each worker a place of employment free from recognized hazards likely to cause death or serious physical harm.
Keeping employees and staff healthy is critical for businesses to continue operating seamlessly and to avoid possible transmission of the virus to patients. Outside renewed or new public health orders, providers must determine what type of screening and testing protocols to implement for their workforces.
ADA-Covered Employers
The Americans with Disabilities Act (ADA) applies to public employers and private employers with 15 or more employees. Enforced by the U.S. Equal Employment Opportunity Commission (EEOC), the ADA continues to apply during a pandemic, but does not interfere with, or prevent employers from following, additional state or local orders set by governors, public health directors or surgeons general.
The ADA requires any mandatory medical test for employees be “job related and consistent with business necessity.” Thus, employers are permitted to test employees entering the workplace for COVID-19, because an individual with the virus poses a direct threat to the health of others, especially in a healthcare setting where patient safety is critical. Therefore, an employer may choose to administer a COVID-19 test or require an employee to provide certification they are virus free.
The ADA continues to apply during a pandemic, but does not interfere with, or prevent employers from following, additional state or local orders set by governors, public health directors or surgeons general.
In addition to testing, employers should ask employees to answer questions about fever, respiratory and other symptoms, and contact with anyone exposed to or diagnosed with COVID-19 within a recent time period before reporting to work.
Employers must maintain such information as a confidential and separate medical record to be in compliance with the ADA.
EEOC Guidance
Guidance issued by the EEOC states that reasonable inquiries, temperature checks and certain medical tests are authorized under the ADA as employer-permitted practices that reasonably relate to a pandemic that poses risks to others. The EEOC has further stated that the use of on-site temperature checks when employees report to work may be helpful in providing practical, real-time answers about whether workers have symptoms and whether they can safely remain for their shift.
It is worth noting that although measuring an employee’s body temperature is considered a medical examination, the CDC and many state/local health authorities have authorized or recommended employers monitor employees’ body temperatures as a safeguard to reduce the spread of the virus.
FDA Guidance
For employers who decide to provide testing to employees, the cost should be borne by the employer. Additionally, the ADA requires employers ensure that tests are accurate and reliable. Employers should review current guidance from the FDA about what tests are considered accurate. For example, serology tests (also known as antibody tests) have faced scrutiny from the medical community, leading the FDA to revise its Emergency Use Authorization (EUA) policy and to subsequently publish a list comparing serology test confidence levels.
Patient Considerations
Screening patients for COVID-19 can be similar to protocols implemented for screening employees. However, testing provided to patients is governed by the Coronavirus Aid, Relief and Economic Security (CARES) Act in addition to other federal and state laws and regulations, rather than by EEOC guidance. Providers may also be required to perform screening or testing of patients pursuant to executive orders signed by governors in certain states.
Providers should monitor the CDC guidelines and state/local public health orders relating to patient-specific screening or testing, which generally will indicate what symptoms to look for, how to prioritize medical treatment or testing, and any social distancing or isolation recommendations based on levels of community spread and reported cases in a geographic area.
Providers should consider the following screening methods for patients:
Pre-appointment screening—Set up phone application symptom checks or telephone calls prior to patient appointments to verify that COVID-19-related or similar symptoms are not present before permitting patients to come on site.
On-site temperature checks—Check patients for fevers at a separate checkpoint, outside or in the waiting room, on arrival. If a fever is present, the patient’s appointment should be rescheduled (so long as the patient is not experiencing a healthcare emergency) after a 14-day period to reduce the risk of transmission. Prior to the date of the rescheduled appointment, the pre-appointment screening should be conducted again and the patient should undergo another on-site temperature check at the time of the appointment.
On-site testing or referrals—For the remainder of the COVID-19 public health emergency, certain COVID-19 tests can be performed in any patient care setting that operates under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. If a healthcare professional is not authorized to perform such tests, they must refer patients to an appropriate testing location. Under the CARES Act, COVID-19 testing and any related treatment must be covered without any patient financial responsibility and without prior authorizations. Providers should consider what types of tests to use (e.g., PCR, antigen or antibody) and the accuracy or confidence levels of those tests.
The FDA clarified that when it grants an Emergency Use Authorization (EUA) for a point-of-care COVID-19 test, CLIA is waived for that test. A point-of-care setting for an EUA test may include physician offices, urgent care, outreach clinics, pharmacies and temporary patient care settings, as long as appropriately trained personnel are available to perform such tests.
To apply for a CLIA certificate, a provider must submit a CMS-116 application form to the CLIA contact in the state where testing will be performed.
Monitor & Maintain an Adequate PPE Supply
The OSHA personal protective equipment (PPE) standards require workers to use gloves, eye and face protection, and respiratory protection when warranted by job hazards, including a viral outbreak.
The bloodborne pathogens standard under OSHA applies to occupational exposure to human blood and other potentially infectious materials that typically don’t include respiratory secretions, but can apply if visible blood is present. These provisions may apply to some sources of the virus, including exposures to bodily fluids that may be present in COVID-19 collection and testing procedures or during standard patient treatment.
These OSHA provisions essentially require employers to supply PPE for employees to establish a uniform standard of safety and a workplace free from hazards. PPE supplies were seriously depleted during the initial months of COVID-19, so providers should take the following steps to ensure PPE is available:
- Check for state governor and public health orders on PPE usage requirements;
- Take an inventory of current PPE and related medical supplies/equipment;
- Use the CDC’s PPE Burn Rate Calculator to determine your PPE usage rate;
- Estimate future months of PPE usage considering varying patient volume;
- Consider PPE optimization and conservation strategies, if possible; and
- If periodic shortages or serious depletion occurs, consider local suppliers/manufacturers.
Leverage Telemedicine Under Current Standards
Sweeping federal and state waivers provide considerable telemedicine flexibility during the COVID-19 pandemic in contrast to standard requirements, not just by the Centers for Medicare & Medicaid Services (CMS) increasing available services and eliminating originating site restrictions, but also through changes in reimbursement parity. Providers should consider how their practices and patients can benefit from continued or expanded telemedicine services and applicable federal waivers and state telehealth waivers, which are monitored through the Federation of State Medical Boards website.
If certain federal telemedicine waivers are no longer in place or have been modified prior to a COVID-19 resurgence, providers should offer telemedicine services only under traditional standards, which include, but are not limited to, complying with provisions under:
- The Health Insurance Portability and Accountability Act;
- CMS; and
- The U.S. Drug Enforcement Administration.
Since the onset of the COVID-19 pandemic, both federal and state authorities have promoted telemedicine for treating patients as a way to reduce transmission of the virus and expand care to patients from the safety of their homes. Although significant progress has been made in offering virtual healthcare under these temporary measures, federal and state governments and regulatory agencies will need to take action to permanently retain these changes once the emergency period has lifted.
Continuing to offer patients the option of virtual care can help providers maintain relative financial stability.
The ACR will continue to help members stay abreast of telemedicine requirements.
Steven M. Harris, Esq., is a nationally recognized healthcare attorney with McDonald Hopkins LLC. Contact him at [email protected].
