On January 31, 2020, U.S. Department of Health and Human Services Secretary Alex Azar declared COVID-19 a public health emergency under Public Health Service Act Section 319. Subsequently, on March 13, 2020, President Trump declared COVID-19 a national emergency under Sections 201 and 301 of the National Emergencies Act. Doing so empowered Sec. Azar to temporarily waive or modify certain requirements for Medicare, Medicaid, and the Children’s Health Insurance program (CHIP) via Social Security Act Section 1135.
Section 1135 waivers are intended to ensure that enough health care items and services are made available to meet the needs of Medicare, Medicaid, and CHIP enrollees in an area affected by an emergency. Such waivers also may shield providers who furnish health care items or services in good faith from sanctions—absent any determination of fraud and abuse. For example, Section 1135 waivers may lift requirements that providers are licensed in the state where they are responding to the emergency if they have equivalent licensure in another state, thereby enabling the provider to be reimbursed for Medicare, Medicaid, or CHIP services. Likewise, 1135 waivers may waive Stark Law self-referral sanctions. An overview of Section 1135 waiver requirements and processes is available from CMS here.
This waiver authority is a critical component of state and federal governmental health programs’ response to emergencies such as the COVID-19 pandemic. The federal government has used this authority to:
- Lift Major Barriers to Telehealth to Help Reduce the Spread of COVID-19;
- Ease HIPAA Applicability and Enforcement to Support Healthcare Delivery During COVID-19 Public Health Emergency;
- Permit More Flexible Medicare Reimbursement of Skilled Nursing Facility Stays;
- Approve Florida’s Waiver Request regarding Provider Enrollment, Prior Authorization Requirements, Pre-Admission Screening, Allowing Use of Alternative Care Settings, and State Fair Hearing Deadlines;
- Approve Washington’s Waiver Request regarding Provider Enrollment, Prior Authorization, Pre-Admission Screening, Allowing Use of Alternative Care Settings, and State Fair Hearing Deadlines; and
CMS’s current emergencies webpage is updated regularly with additional waiver requests and grants and includes a fact sheet on the emergency declaration. As one would expect given the emergency, CMS is acting swiftly to review and approve state waiver requests. For example, Florida’s request was approved within three days and Washington’s within four. Some states, such as Arizona, have submitted requests for both an 1135 waiver and 1115 waiver to address COVID-19. We expect more waiver requests in the coming weeks as states and the federal government continue to explore solutions to the challenges of COVID-19.