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Section 1135 Waivers and COVID-19: An

Overview



March 25, 2020
In response to the novel Coronavirus (COVID- 19) outbreak in the United States, both Congress and the
Trump Administration have acted to confront the challenges of providing health care to sick patients.
These efforts have included the provision of certain regulatory flexibilities for health care entities under
Section 1135 of the Social Security Act (42 L.S.C  1320b-5). To address the difficulties of providing
health care in exigent circumstances, Section 1135 generally authorizes the Secretary of Health and
Human Services (HHS Secretary) to waive or modify specified statutory and regulatory requirements
related to the provision of health care services under the Medicare, Medicaid, and State Children's Health
Insurance (CHIP) programs (so-called Section 1135 waivers). In recent years, the HHS Secretary has
issued Section 1135 waivers several times, most commonly for natural disasters. This Legal Sidebar
summarizes Section 1135 and recent legislative and administrative developments relating to this authority.

Legal Framework
The general purpose of Section 1135 is to help ensure that in an emergency or disaster, health care
program enrollees have sufficient access to health care, and health care providers can continue to furnish
care, despite noncompliance with certain federal requirements. To the extent necessary to carry out this
purpose, Section 1135 permits the HHS Secretary to waive or modify the following federal requirements
when the President has declared an emergency or major disaster under either the National Emergencies
Act or the Stafford Act, and the HHS Secretary has declared a public health emergency:
    *  conditions of participation, certification requirements, program participation, and pre-
       approval requirements under Medicare, Medicaid, or CHIP;
    *  licensing requirements for health care professionals in each state in which they provide
       services, assuming they are not excluded from practicing in the relevant state or
       emergency area;
    *  sanctions under the Emergency Medical Treatin ent and Active Labor Act (EMTALA) for
       certain transfers or redirections of patients away from hospital emergency rooms;
    *  deadlines and timetables for performance of required activities;


                                                                Congressional Research Service
                                                                  https://crsreports.congress.gov
                                                                                    LSB10430

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