CMS issues temporary waivers to allow hospital services to be provided in community-based locations and clarifies the applicability of EMTALA for locations outside of the hospital

On March 30, 2020, Centers for Medicare and Medicaid Services (CMS) issued temporary regulatory waivers and new rules to allow hospitals and healthcare systems to deliver services at offsite community-based locations in order to reserve hospital bed capacity for coronavirus disease 2019 (COVID-19) patients needing acute care in their main facilities. The CMS waivers issued under the “Hospitals Without Walls” campaign complement the work of the Federal Emergency Management Agency (FEMA) and state and local public health authorities by empowering hospitals to rapidly expand treatment capacity and separate infected from uninfected patients. These waivers permit patients to be triaged to a variety of community-based locales, including ambulatory surgery centers (ASCs), inpatient rehabilitation hospitals, hotels, and dormitories. Transferring uninfected patients to community-based locations will relieve hospitals at or near capacity, allow hospital staff to focus on the most critical COVID-19 patients, maintain infection control protocols, and conserve personal protective equipment (PPE).

ASCs seeking to treat hospital patients can either contract with local healthcare systems to provide hospital services, become provider-based to a hospital, or enroll with Medicare and bill as hospitals during the emergency declaration, provided that doing so does not contradict the state emergency plan. The new rules also permit hospitals to bill for services provided outside their four walls under arrangement. Notably, however, hospitals and any provider-based departments, including the temporary expansion provider-based departments, must meet Medicare’s Conditions of Participation for hospitals, which have not been waived. CMS released an updated FAQ document on April 9 that addresses participation and billing requirements outside of hospital walls, as well as other changes to billing as a result of the new waivers.

To accompany the Hospitals Without Walls campaign, the CMS Quality Safety and Oversight Group issued a memorandum concerning how the requirements under the Emergency Medical Treatment and Labor Act (EMTALA) relate to COVID 19, including how EMTALA applies to the establishment of drive through testing sites, the clarification of expectations in relation to the triage process and the medical screening examination, and the use of telehealth.  Only two aspects of the EMTALA requirements can be waived under 1135 Waiver Authority: 1) transfer of an individual who has not been stabilized, if the transfer arises out of an emergency, or 2) redirection to another location (offsite alternate screening location) to receive a medical screening exam (MSE) under a state emergency preparedness or pandemic plan. CMS’s EMTALA waiver allows hospitals, psychiatric hospitals, and critical access hospitals (CAHs) to screen patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19.  Notably, however, this waiver of EMTALA sanctions is effective only if actions under the waiver do not discriminate as to source of payment or ability to pay.

EMTALA requires Medicare-participating hospitals and CAHs with a dedicated emergency department (ED) to provide an MSE to every individual who comes to the ED with an emergency medical condition (EMC); provide necessary stability treatment; and provide for transfers of individuals with EMCs when appropriate.

This guidance supplements CMS’s decision to approve an 1135 waiver for the enforcement of EMTALA, section 1867(a) of the Social Security Act, for the duration of COVID-19.  The CMS waiver further allows hospitals to direct or relocate individuals who come to the ED to an alternative off-campus site for the MSE.

The memorandum provided guidance to hospitals regarding EMTALA compliance during the COVID-19 pandemic:

• Accepting patients with COVID-19 from another hospital. Hospitals with capacity and specialized capabilities are required to accept transfers of patients with suspected or confirmed COVID-19 from hospitals without the necessary capabilities to treat such persons, but the receiving hospital may refuse the transfer if it does not have the capacity to provide the necessary care.
• Alternative On-Site ED locations. Hospitals may set up alternative screening sites on the hospital campus for MSEs. A qualified person (e.g., Registered Nurse) should redirect individuals who need immediate treatment to the ED. Individuals do not need to present to the ED prior to going to the alternative screening site to be considered as present in the ED for purposes of EMTALA.
• No EMTALA obligations for off-site locations or community testing stations. Hospitals may also set up off-site locations for screening COVID-19 cases, but off-site locations are not subject to EMTALA. Hospitals cannot tell an individual to go off-site for COVID-19 testing unless they have provided the patient with an MSE and determined that the individual does not have an EMC. Off-site locations should be staffed with personnel who can screen for respiratory or potential/presumed COVID-19. Community or hospital testing stations (e.g., malls, retail parking lot drive-through testing locations) are not governed by EMTALA, even if hospital personnel assist with the testing. Protocols should be put in place to transport patients who arrive at off-site locations or community testing locations in medical distress to the hospital.
• Performing MSEs via Telehealth. Hospitals may use telehealth equipment to conduct MSEs by qualified medical personnel (including physicians, nurse practitioners, physician’s assistants, or registered nurses trained to perform MSEs and acting within the scope of their state licensure) when the qualified medical personnel are on campus or off-site, provided that this practice is permitted under state law and approved by the applicable hospital.

This recent set of CMS guidance, when read in coordination with CMS Stark Law waivers, suggests that hospitals, physicians, surgery centers, and other providers may proactively pursue arrangements to address COVID-19 concerns that may otherwise be impermissible. Notably, providers should remain vigilant to account for state licensure and mini-Stark laws which may still limit provider arrangements. Ultimately, however, CMS’s continued easing of barriers to care access may offer a viable solution to patients in dire need of medical care, hospitals suffering from overcapacity, and providers and other institutions struggling to survive under challenging economic circumstances.

DLA Piper continues to closely monitor federal and state waivers and other governmental actions as this situation unfolds. For information on other ways COVID-19 is changing the healthcare industry and how your company can help serve patients, please contact your DLA Piper relationship partner or any member of our healthcare industry group. Please visit our Coronavirus Resource Center and subscribe to our mailing list to receive alerts, webinar invitations and other publications to help you navigate this challenging time. 

This information does not, and is not intended to, constitute legal advice. All information, content, and materials are for general informational purposes only. No reader should act, or refrain from acting, with respect to any particular legal matter on the basis of this information without first seeking legal advice from counsel in the relevant jurisdiction.