Does the Covid-19 Pandemic Change a Hospital’s Obligations under EMTALA?

Robert A. Bitterman, MD, JD, FACEP

TAKE-HOME:  Although hospitals are now allowed to direct patients off-site for Covid-19 screening, most existing emergency department (ED) EMTALA requirements are still in place during the Coronavirus pandemic. These include the requirement to screen and stabilize every individual who presents to the ED and to accept transfers from hospitals that lack the necessary capability or capacity to stabilize patients with emergency conditions, including Covid-19.

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Early in the pandemic, on March 9, 2020, the Centers for Medicare and Medicaid (CMS) issued guidance related to the Coronavirus confirming and reminding hospitals that their responsibilities under the Emergency Medical Treatment & Labor Act (EMTALA) had not changed one iota. [1]

Alternative EMTALA Screening Sites

Hospitals have always had a high degree of flexibility in how they screen patients presenting to the emergency department (ED), and CMS specifically pointed out how hospitals can set up alternative screening sites on the hospital’s campus which comply with EMTALA. For example, a hospital could set up a van or tent outside the ED and direct patients with suspected Coronavirus or respiratory infections to these on-campus locations for screening prior to or instead of entry into the main ED. This is very similar to hospitals screening pregnant women up in L&D instead of in the ED.

However, when it became evident that the pandemic would overwhelm some of our nation’s hospitals, HHS/CMS issued a ‘blanket’ section 1135 waiver which, among many other things, temporarily modified the ED medical screening examination mandate of EMTALA. [2] This waiver was issued on March 30, 2020, effective retroactively to March 1^st. It has been reissued a number of times, most recently on October 2^nd, and is expected to remain in effect for the duration of the pandemic. [3]

The only EMTALA change allowed by the waiver is that under certain circumstances hospitals may redirect patients away from the ED to an off-campus location for their medical screening examination.

It must be emphatically emphasized that all other aspects of EMTALA remain entirely in effect!

Prior to the waiver, hospitals were not allowed under any circumstance to direct patients away from the ED for medical screening to an off-campus location, such as an urgent care center, public health clinic, or any other clinical facility.

Alternative Medical Screening (MSE) Locations – On-Campus:

• Hospitals may set up alternative screening sites ‘on-campus’ rather than the ED to where individuals can be redirected to receive a MSE.
• Redirection to the alternative screening site can take place before the individuals have even entered the hospital or ED.
• Hospital personnel directing individuals to the alternative sites should be qualified (e.g., an RN) to recognize those in need of immediate treatment in the ED.
• Whatever screening process the hospital establishes on-campus must be based on medically indicated criteria and not discriminate as to source of payment or ability to pay.
• The hospital must still maintain a log of all patients presenting to the ED or the alternative on-campus screening site, in the same manner prescribed by CMS regulations for the ED itself.
• The alternative sites must be staffed by qualified medical providers who are authorized by the hospital’s governing body to conduct MSEs on behalf of the hospital.

Alternative Medical Screening (MSE) Locations – Off-Campus:

• Because of the CMS waiver hospitals may temporarily redirect patients to off-campus locations to receive their medical screening exam.
• The waiver is applicable only if the hospital’s redirection does not discriminate among individuals based on their source of payment or ability to pay.
• The redirection to off-campus sites must be in accordance with a state’s emergency preparedness or pandemic plan.
• The alternative site must be staffed by qualified medical workers.
• The hospital does not have to initiate its disaster plan in order to take advantage of the waiver.
• These off-campus ‘temporary expansion locations’, as termed by CMS, may serve multiple hospitals (with different MC provider numbers) if it is consistent with their state emergency plan.
• CMS expects that hospitals can generally manage the separation and flow of potentially infectious patients through alternative screening locations on the hospital’s campus. Therefore, expect that redirection to off-campus locations not owned or operated by the hospital will be strictly scrutinized by CMS on a case by case basis.
• State and local governments, communities, or non-hospital providers may also set up medical screening clinics at sites not under the control of a hospital, and there is no EMTALA obligation at these sites.
• Hospitals can also set up screening sites at their own off-campus locations, and as long as those locations don’t qualify as dedicated emergency departments under CMS’s EMTALA regulations, EMTALA will not apply at those locations.

Covid-19 Testing Sites:

• Hospitals may establish testing sites for Covid-19 either on-campus or off-campus, including ‘drive-through’ testing, and a MSE is not required at either location. EMTALA does not apply.
• If the testing is done on-campus, it is recommended that the hospital have the patient sign a form indicating that the patient is presenting solely for the purpose of Covid-19 testing and is not requesting a medical screening exam for examination or treatment of a medical condition under EMTALA. If the person complains of or exhibits any symptoms of a medical condition, then the person should be offered a MSE to determine if an emergency condition exists.
• Patients presenting on-campus solely for the purpose of Covid-19 testing may be redirected to off-campus testing sites, either hospital owned or non-hospital owned sites, for that testing without the hospital performing a MSE prior to redirection. Again, if the person complains of or exhibits any symptoms of a medical condition, then the person should be offered the MSE to determine if an emergency condition exists before redirection for testing.

Signs:

• It is a violation of EMTALA for hospitals with EDs to use signs that create a (real or perceived) barrier to individuals who are suspected of having COVID-19 from coming to the ED.
• However, posting signs that are designed to help direct individuals to various on-campus alternative locations for their MSE are allowed.
• Posting signs that direct patients seeking only Covid-19 testing (as opposed to seeking a MSE) to either on-campus or off-campus locations are allowed.

Transfers:

• The EMTALA obligation to accept appropriate accept transfers from other hospital EDs that lack the necessary capability or capacity to stabilize patients with emergency conditions is still in force for Covid-19 patients.
• The presence of absence of negative pressure rooms (Airborne Infection Isolation Rooms) is not the sole determining factor related to transferring patients from one setting to another when in most cases all that is required for appropriate care is a private room.

 EMTALA Complaints:

• If CMS receives an EMTALA-related complaint, it will take into consideration CDC guidance and state or local public health direction at the time of the alleged noncompliance.
• It will also take into account any clinical considerations specific to the individual case.

Final Recommendations:

I strongly encourage all hospital providers and management to read the CMS March 30, 2020 Memo on EMTALA and Covid-19, and the CMS April 30, 2020 ‘Frequently Asked Questions’ publication on EMTALA and Covid-19. These publications are comprehensive, practical, and very well written with respect to understanding the EMTALA issues the pandemic presents to hospital emergency departments.

In general, regardless of the waiver, hospitals should continue to follow all the usual EMTALA requirements unless they somehow significantly impede patient care.

Two important caveats remain:

1. Whatever screening process the hospital establishes on- or off-campus must be based on medically indicated criteria and provided to all comers on a non-discriminatory basis.
2. The hospital must still maintain a log of all patients presenting to the ED, in the same manner prescribed by CMS regulations for the ED itself.

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References:

1. CMS QSO-20-15 Hospital/CAH/EMTALA, March 9, 2020. Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19). Available at: https://www.cms.gov/files/document/qso-20-15-hospitalcahemtala.pdf
2. CMS COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, March 30, 2020, including the EMTALA Waiver. Available at: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf
3. On October 2, 2020 HHS Secretary Azar issued another 90-day extension to the national emergency declaration for Covid-19, effective when the prior extension expires on October 23, 2020. Thus, the new expiration dates is now January 21, 2021.  https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx
4. CMS QSO-20-15 Hospital/CAH/EMTALA REVISED, March 30, 2020, Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19) (Revised)  https://www.cms.gov/files/document/qso-20-15-hospital-cah-emtala-revised.pdf
5. CMS: Frequently Asked Questions for Hospitals and Critical Access Hospitals regarding EMTALA and Covid-19, April 30, 2020. Available at:  https://www.cms.gov/files/document/frequently-asked-questions-and-answers-emtala-part-ii.pdf

Link to Our 2020 EMTALA Update Training Class

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EMTALA Covid-19 Waiver

CMS Frequently Asked Questions – Coronavirus – EMTALA Covid-19 Waiver

Robert A. Bitterman, MD, JD, FACEP

© 2020, ED Quality Solutions, LLC, All Rights Reserved

TAKE-HOME:  Most existing emergency department (ED) EMTALA requirements are still in place during the Coronavirus pandemic, including the requirement to screen and stabilize every individual who presents to the ED, and to accept transfers from hospitals that lack the necessary capability or capacity to stabilize patients with emergency conditions, including Covid-19. Hospitals are now allowed to direct patients off-site for Covid-19 screening.

Click to see our new EMTALA Update Class

New CMS Guidance on Coronavirus – FAQs

On April 28^th, the Centers for Medicare and Medicaid Services (CMS) issued Frequently Asked Questions related to Coronavirus. The CMS FAQs are available at https://www.cms.gov/files/document/frequently-asked-questions-and-answers-emtala-part-ii.pdf.

The only substantive change was to allow hospitals to direct patients away from the ED to an off-campus location for screening.

In spite of this waiver, most hospitals are still screening Covid-19 patients on campus.

The new FAQs are intended to more fully explain the March 9^th and March 30^th CMS guidance related to Coronavirus.

(see EMTALA-Coronavirus-COVID-19).

The March 9^th CMS memo is available at https://www.cms.gov/files/document/qso-20-15-hospitalcahemtala.pdf and the March 30^th revision is available at https://www.cms.gov/files/document/qso-20-15-hospital-cah-emtala-revised.pdf. ACEP’s summary of the CMS’s EMTALA Coronavirus guidance is available at https://www.acep.org/globalassets/summary-of-covid-19-emtala-guidance.pdf

Two important caveats remain:

1. Whatever screening process the hospital establishes on- or off-campus must be based on medically indicated criteria and provided to all comers on a non-discriminatory basis.
2. The hospital must still maintain a log of all patients presenting to the ED, in the same manner prescribed by CMS regulations for the ED itself.

Please contact our office if you have specific EMTALA legal questions. Our healthcare attorneys are standing by to assist you.

Are Hospital Obligations Under EMTALA Changed by the Coronavirus?

Robert A. Bitterman, MD, JD, FACEP

© 2020, ED Quality Solutions, LLC, All Rights Reserved

Click to see our new EMTALA Update Class!

(See May 5, 2020 Update: EMTALA-Coronavirus-COVID-19 )

At the present time the answer is ‘no’; however, in the very near future waiver of some of the emergency department (ED) EMTALA obligations is possible. Therefore, existing EMTALA requirements are now still in place during the Coronavirus pandemic, including the requirement to screen and stabilize every individual who presents to the ED, and to accept transfers from hospitals that lack the necessary capability or capacity to stabilize patients with emergency conditions, including Covid-19.

New CMS Guidance on Coronavirus

On March 9^th CMS issued guidance related to Coronavirus disease confirming and reminding hospitals of their EMTALA obligations. The CMS memo is available at https://www.cms.gov/files/document/qso-20-15-hospitalcahemtala.pdf.

ACEP created a summary of CMS’s EMTALA Coronavirus guidance which is available at https://www.acep.org/globalassets/summary-of-covid-19-emtala-guidance.pdf

Hospitals have always had a large degree of flexibility in how they screen patients presenting to the ED, and CMS specifically pointed out how hospitals can set up alternative screening sites on the hospital’s campus. For example, a hospital could set up a van or tent outside the ED and direct patients with suspected Covid-19 or respiratory infections to these locations for screening prior to or instead of entry into the main ED. This is very similar to hospitals screening pregnant women in L&D instead of in the ED. Hospitals have wide latitude on where and how they screen patients on the hospital’s campus.

There are three important caveats, however:

1. The hospital may not direct patients away from the ED to an off-campus location for screening.

2. Whatever screening process the hospital establishes on-campus must be based on medically indicated criteria and provided to all comers on a non-discriminatory basis.

3. The hospital must still maintain a log of all patients presenting to the ED, in the same manner prescribed by CMS regulations for the ED itself.

Hospitals can set up Covid-19 screening sites at their off-campus locations. As long as those locations do not qualify as dedicated emergency departments under CMS’s EMTALA regulations, EMTALA will not apply at those locations. But again, the hospital may not tell individuals who have already come to its ED to go to such off-campus locations.

State and local governments, communities, or non-hospital providers may also set up coronavirus screening clinics at sites not under the control of a hospital, and there is no EMTALA obligation at these sites. Furthermore, area hospitals and community officials may encourage the public to go to alternative sites instead of the hospital for screening.

Waiver of EMTALA

‘Waiver’ of the EMTALA rules and regulations is rarely done and quite limited, but is a realistic possibility under § 1135 of the Social Security Act if the Coronavirus pandemic continues to expand regionally or nationally.

There are 5 legal prerequisites to a waiver of EMTALA under § 1135 of the Act;

1. The President must declare an emergency or disaster under the Stafford Act or the National Emergencies Act; and
2. The Secretary of HHS declares a Public Health Emergency (PHE) under § 319 of the Public Health Service Act; and
3. The Secretary of HHS authorizes waivers under § 1135 of the Social Security Act and has delegated to CMS the specific authority to waive sanctions for certain EMTALA violations that arise as a result of the circumstances of the emergency; and
4. The hospital in the affected area has implemented its hospital disaster protocol; and
5. CMS has determined that sufficient grounds exist for waiving EMTALA sanctions with respect to a particular hospital or geographic area.

However, there are only two EMTALA provisions for which the sanctions can be waived under a § 1135 waiver.

1. For an inappropriate transfer (if the transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period); and
2. For the relocation or direction of an individual to receive medical screening in an alternate location off the hospital’s campus pursuant to an appropriate State emergency preparedness plan or State pandemic preparedness plan.

On January 31^st, HHS Secretary Alex Azar declared a public health emergency for the entire United States, and on March 13^th, President Trump proclaimed the Coronavirus a national emergency under the National Emergencies Act.

Additionally, the President’s proclamation granted the HHS Secretary the authority under section 1135 to temporarily waive or modify certain Medicare requirements, including EMTALA. However, the Secretary must provide a certification and at least two-day notice to Congress describing the provisions waived or modified, the geographic area to which they will apply, and the time period the changes will remain in effect. The Secretary does have the option to issue Covid-19 waivers on a ‘blanket’ basis, when a determination has been made that all similarly situated providers in an emergency area needed such a waiver. An example would be hospitals that have initiated their disaster plans to address a flood of Coronavirus patients presenting to their EDs, being granted an EMTALA waiver.

Moreover, if hospitals want to divert or redirect individuals with suspected Coronovirus to receive medical screening in an alternate location off the hospital’s campus, it must be pursuant to an appropriate State emergency preparedness plan or State pandemic preparedness plan, and the hospital must have initiated its emergency or disaster protocol. Thus, the State and the individual hospital also have a role in determining when an EMTALA waiver will be granted.

Waivers of sanctions under the EMTALA in the emergency areas generally end 72 hours after implementation of the hospital’s disaster plan. However, if the public health emergency involves a pandemic infectious disease, such as the Coronaviurs, the waiver of sanctions under EMTALA is extended until the termination of the pandemic-related public health emergency.

Additionally, the statute provides that the waiver is applicable only if the hospital’s actions do not discriminate among individuals based on their source of payment or ability to pay.

In summary, at least at the moment, the criteria for ‘waivier’ of EMTALA have not been met.

Over the weekend CMS did issue blanket waivers of some of the Medicare regulations, but did not include EMTALA. You can see what CMS did issue at this link https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf or here: COVID-19 CMS Emergency Declatation FactSheet.

There is a host of material on CMS’s various web sites regarding pandemics/public health emergencies and EMTALA. I’d recommend you start with the March 9, 2020 CMS guidance memo and the ACEP summary of that guidance as noted above. Next, review the CMS 1135 Waiver website at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/1135-Waivers. It has everything you need to understand how a section 1135 waiver could be implemented for hospitals and emergency departments to deal with the Coronavirus crisis.

For questions on Section 1135 waivers for EMTALA you can send an email to 1135waiver@cms.hhs.gov. You need to include the city and state of your location so CMS can route your inquiry appropriately.

Finally, also helpful is the HHS 2018 Fact Sheet / Q&As on EMTALA and Disasters. It is available at:  https://asprtracie.s3.amazonaws.com/documents/aspr-tracie-fact-sheet-emtala-and-disasters.pdf

Please contact our office if you have specific EMTALA legal questions. Our healthcare attorneys are standing by to assist you.