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HHS Waives Certain EMTALA Requirements, Medicare Conditions of Participation, and HIPAA Sanctions during the COVID-19 Pandemic
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EMTALA Waiver and Other Implications Secretary Alex Azar of HHS announced the waiver of sanctions under EMTALA[1]. Generally, EMTALA requires Medicare-participating hospitals and critical access hospitals (CAH) that have a dedicated emergency room to, at a minimum, do the following:
Under the EMTALA waiver, hospitals will not be sanctioned during the State of Emergency for: (1) not performing an MSE at the hospital emergency department and directing a patient from a hospital emergency department to another location (this would be an off-campus, non-hospital location) to receive the MSE, but only if that other location was set up pursuant to an appropriate state emergency preparedness plan and (2) transferring a person who has not been stabilized (under circumstances EMTALA would otherwise prohibit) if the “transfer is necessitated by the circumstances of the declared Federal public health emergency for the COVID-19 pandemic.” Prior to the declaration of a State of Emergency, on March 9, 2020, the CMS Quality, Safety and Oversight Group (“QSO”) issued a memorandum, QSO-20-15, providing guidance to health care providers related to EMTALA implications during the COVID-19 pandemic. The first EMTALA implication that CMS addressed in the QSO-20-15 guidance is hospitals with capacity, and the specialized capabilities needed for stabilizing treatment for patients with suspected or confirmed COVID-19, are required to accept appropriate transfers from small or rural hospitals that do not have appropriate or sufficient isolation facilities. CMS suggests hospitals should coordinate with their state/local public health officials regarding appropriate placement of individuals who meet specified COVID-19 assessment criteria and the most current standards of practice for treating individuals with confirmed COVID-19 infection status. CMS stated that to determine if a violation of these EMTALA obligations under the COVID-19 pandemic had occurred, CMS will evaluate both the capabilities and capacity of both the referring and recipient hospitals. Among other things, CMS will take into account the Centers for Disease Control (CDC) recommendations at the time of the event in question when assessing whether a hospital had the requisite capabilities and capacity. CMS noted the CDC recommendations focus on factors – such as the individual’s recent travel or exposure history and presenting signs and symptoms – in differentiating among the capabilities hospitals should have to screen and treat an individual. According to CMS, the presence or absence of negative pressure rooms, known as Airborne Infection Isolation Room (AIIR, will not be the sole determining factor related to transferring patients from one setting to another. Another EMTALA implication addressed by CMS in the QSO-20-15 guidance is all Medicare-participating hospitals with specialized capabilities are required to accept appropriate transfers of individuals with EMCs if the hospital has the specialized capabilities an individual requires for stabilization, as well as the capacity to treat these individuals. The recipient hospital obligation applies regardless of whether the hospital has a dedicated emergency department. The full QSO-20-15 guidance is available here. Waivers and Flexibilities for Hospitals and other Health Care Facilities CMS has temporarily waived or modified certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements for the following providers and health care facilities during the COVID-19 pandemic:
During the pandemic, CMS will temporarily suspend certain Medicare enrollment screening requirements, including site visits and fingerprinting for non-certified Part B suppliers, physicians, and non-physician practitioners. In addition CMS will allow licensed providers to render services outside their state of enrollment. CMS will also establish a toll-free hotline for providers to enroll and receive temporary Medicare billing privileges. Suspension of Enforcement Activities CMS will temporarily suspend non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse. Medicare Appeals in Fee for Service, Medicare Advantage Claims, and Part D CMS has also issued the following waivers regarding Medicare appeals:
The national emergency declaration also enables CMS to grant state and territorial Medicaid agencies a wider range of flexibilities under section 1135 waivers. States and territories are now encouraged to assess their needs and request these available flexibilities, which are outlined in the Medicaid and CHIP Disaster Response Toolkit. Examples of flexibilities available to states under section 1135 waivers include the ability to permit out-of-state providers to render services, temporarily suspend certain provider enrollment and revalidation requirements to promote access to care, allow providers to provide care in alternative settings, waive prior authorization requirements, and temporarily suspend certain pre-admission and annual screenings for nursing home residents. For more information CMS encourages providers to review the Disaster Response Toolkit available here. The CMS press release announcing these waivers is available here. A CMS factsheet for providers highlighting these waivers is available here. Waiver of Health Insurance Portability and Accountability (HIPAA) Sanctions and Penalties HHS has also waived sanctions and penalties arising from noncompliance with the following HIPAA privacy regulatory provisions: (a) the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510); (b) the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and (c) the requirement that a patient has a right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522). These waivers only apply to hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect and for a period not to exceed 72 hours beginning upon implementation of the hospital disaster protocol. These waivers are expected to be in place during the COVID-19 pandemic. The full HHS waiver can be accessed here. If you have any questions regarding these waivers issued by CMS during the national emergency for the COVID-19 pandemic or you require assistance with any related matters, please contact your Dinsmore health care attorney.
[1] 42 U.S.C. § 1395dd.
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