Health Law Monitor

By: Alaina N. Crislip and Neil C. Brown

The Emergency Medical Treatment and Active Labor Act (“EMTALA”) requires a hospital to properly screen and stabilize all patients that present to the emergency room for care.¹ There is inherent tension between a hospital’s legal and ethical obligations and the realities of responding to a pandemic disaster.  During the current COVID-19 pandemic, the significant surge the health care system is facing raises concerns about a hospital’s ability to comply with EMTALA requirements under such unprecedented circumstances.  Hospital must review their legal obligations under EMTALA during this pandemic so they can be protected from liability for potential, and often unavoidable, EMTALA violations.  

EMTALA generally prohibits all Medicare-program participating hospitals with a dedicated emergency room from denying emergency medical treatment to individuals, regardless of ability to pay.  Additionally, it requires hospitals to provide an appropriate medical screening examination (“MSE”) to determine if an emergency medical condition (“EMC”) exists. If such an EMC exists, the hospital must provide stabilizing treatment before transferring or discharging the patient.  

CMS ISSUES GUIDELINES

On March 9, 2020, CMS issued a summary of requirements and implications prompted by the onset of the COVID-19 outbreak in the U.S.² Among other topics, CMS specified that hospitals and critical access hospitals are required to: (1) conduct an appropriate MSE of all individuals who come to the ED, including individuals who are suspected of having COVID-19, regardless of whether they arrive by ambulance or walk in; (2) provide necessary stabilizing treatment for individuals with EMCs within the hospital’s capability and capacity; and (3) provide for transfers of individuals with EMCs, when appropriate. CMS notes that it will evaluate both the capabilities and capacity of the referring and recipient hospitals in order to determine whether a violation has occurred.  

CMS described the permissible type of screening locations that hospitals and communities may establish.  

• A hospital may set up alternative screening sites on campus.  CMS notes that the MSE does not have to take place in the ED, and after logging in patients, the patients may be redirected to the on-campus screening location.  
• Hospitals may set up screening locations off-campus at hospital-controlled sites.  
• Communities are permitted to set up screening clinics at sites not under the control of the hospital.  The community sites would not be subject to EMTALA. Hospitals and communities are permitted to encourage the public to use these community screening clinics, but a hospital may not tell individuals who have already presented to the ED to go to the off-site location for an MSE. 

As part of fulfillment of a hospital’s MSE requirements under EMTALA as described in the CMS summary, a hospital that concludes a possible COVID-19 case, consistent with accepted standards of practice for COVID-19 screening, is expected to immediately isolate the patient. 

DECLARATION OF NATIONAL EMERGENCY AND EMTALA WAIVERS

The President’s declaration of a national emergency under the Stafford Act on March 13, 2020 may now lead the way for hospitals not only to get additional funding needed, but also to obtain a waiver from MSE and stabilization requirements under EMTALA, so long as other factors are met.   The EMTALA MSE and stabilization requirements can be waived only if all of the following four conditions apply, noting that ALL have already been met:³ 1) The President has declared an emergency or disaster under the Stafford Act or the National Emergencies Act; 2) The Secretary of HHS has declared a Public Health Emergency (this was declared by Secretary Azar on January 31, 2020)⁴ ; 3) The Secretary invokes his waiver authority, and notifies Congress at least 48 hours in advance; and 4) The waiver includes a waiver of EMTALA requirements and the hospital is covered by the waiver. 

Hospitals should review the recent guidance related to 1135 waivers⁵  issued by Secretary Azar. The issuance of the 1135 waiver, waives or modifies the following requirements: 

• Certain conditions of participation, certification requirements, program participation or similar requirements for individuals’ health care providers or types of health care providers, including as applicable, a hospital to other provider of services, a physician or other health care practitioners or professional, a health care facility, or a supplier of health care items or services, and pre-approval requirements;
• Requirements that physicians or other health care professionals hold licenses in the State which they provide services, if they have an equivalent license in another State (and are not affirmatively barred from practice in that State or any State a part of which is included in the emergency area);
• Sanctions under EMTALA for the direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency for the COVID-19 pandemic; 
• Sanctions under 1877(g) (relating to limitations on physician referrals) under such conditions and in such circumstances as CMS determines appropriate;
• Limitation on payments under section 1851(i) of the Act for health care items and services furnished to individuals enrolled in Medicare Advantage plans by health care professional or facilities not included in the plan’s network;
• HIPAA sanctions and penalties arising from non-compliance are waived for: (a) the requirements to obtain a patient’s agreement to speak with family member or friends or to honor a patient’s request to opt out of a facility directory⁶; (b) the requirement to distribute a notice of privacy practices ; and (c) the patient’s right to request privacy restrictions or confidential communications , but in each case, only with respect to hospitals in the designated geographic area in which the hospital disaster protocols are in operation during the time the waiver is in effect; and
• Deadlines and timetables for the performance of required activities are waived, but only to the extent necessary as determined by CMS, to ensure that sufficient health care items and services are available to meet the need of individuals enrolled in Medicare, Medicaid and CHIP programs and to ensure that health care providers that furnish these services in good faith, but are unable to comply with one or more requirements due to COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent a determination of fraud and abuse. 

This waiver issued by Secretary Azar became effective on March 15, 2020 and will be retroactive to March 1, 2020, nationwide.  

CMS has also issued blanket waivers covering the following: 

• Hospitals 
  • Requirements to allow acute care hospitals to house inpatients in excluded distinct part units where the bed is appropriate for inpatient care and needed due to capacity issues related to the emergency.
  • Allowing acute care hospitals with excluded distinct part inpatient psychiatric units to relocate inpatients from the psychiatric unit to an acute care bed/unit, if appropriate for psychiatric care, as needed as a result of the emergency.
  • Allowing acute care hospitals with excluded distinct part rehabilitation units to relocate inpatients from the rehabilitation unit to an acute care bed/unit, if appropriate for rehabilitation care, as needed, as a result of the emergency.
• Critical Access Hospitals 
  • 25 bed limit.
  • 96 hour length-of-stay limit.
• Skilled Nursing Facilities (SNF) 
  • Waived the three-day prior hospitalization requirement for coverage of a SNF stay for those patients needing to be transferred to a SNF as a result of the emergency.
  • Waived 42 CFR 483.20 of timeframe requirements for Minimum Data Set assessments and transmission.
• Long-Term Acute Care Hospitals (LTCH) 
  • Ability to exclude patient stays where the LTCH admits or discharges patients in order to meet demand of the emergency from the 25-day average length-of-stay requirement.
• Home Health Agencies 
  • Ability for Medicare Administrative Contractors to extend the auto-cancellation date of Request for Anticipated Payment during the emergency.
• Durable Medical Equipment 
  • Permission for contractors to waive replacement requirements such that the face-to-face requirement, a new physician’s order and new medical necessity documentation are not required when equipment is lost, destroyed, irreparably damaged or otherwise rendered unusable as a result of the emergency.
• Provider Enrollment 
  • Establishing a toll-free hotline for physicians, non-physician practitioners and suppliers to enroll and receive temporary Medicare billing privileges.
  • Waived application fee, fingerprint-based criminal background checks and site visits.
  • Postponement of all revalidation actions.
• Provider Locations 
  • Waived the requirement that out-of-state providers be licensed in the state where they are providing service if licensed in another state. (Note that this applies to the Medicare/Medicaid requirement only. It does not waive state licensing requirements.) 

This situation is evolving rapidly day by day. The information discussed in this alert is subject to change in the coming days. We will strive to get you critical information to enable you to continue operations on the front-lines. 

¹  42 U.S.C. §1395dd.
²  See Centers for Medicare & Medicaid Services, Emergency Medical Treatment and Labor Act (EMTALA) Requirements and Implications Related to Coronavirus Disease 2019 (COVID-19), available at https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/emergency-medical-treatment-and-labor-act-emtala-requirements-and-implications-related-coronavirus
³  See, e.g., Centers for Medicare & Medicaid Services, 1135 Waiver – At a Glance, available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Downloads/1135-Waivers-At-A-Glance.pdf
⁴  See, e.g., Department of Health & Human Services, Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus
⁵ Centers for Medicare & Medicaid Services, COVID-19 Emergency Declaration Health Care Providers Fact Sheet, available at https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf
⁶  45 C.F.R. § 164.510
⁷  45 C.F.R. § 164.520
⁸  45 C.F.R. §164.522
⁹  https://www.cms.gov/newsroom/press-releases/cms-takes-action-nationwide-aggressively-respond-coronavirus-national-emergency