The Centers for Medicare and Medicaid Services (CMS) has a link to the mandatory 1135 Waivers posted on their website for the Emergency Preparedness Rule (originally called the Emergency Preparedness Final Rule or EPFR).

The  1135 Waivers link above provides the full 1135 Waivers requirements.  However, the purpose of this article is not to discuss the full 1135 Waivers requirements.

Some healthcare facilities that are subject to the CMS Conditions of Participation (CoPs) have determined it would be preferable in the current COVID-19 response situation to reduce their compliance with some CMS-mandated inspection, testing, and maintenance activities.  Reducing compliance with the frequencies of these mandatory activities requires use of the 1135 Waivers requirements. The existing CMS COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers as of April 9, 2020 do not contain any waivers of mandatory inspection, testing, and maintenance requirements.

The American Society for Healthcare Engineering recently posted two very useful MS Word documents on its COVID-19 webpage.  These documents are available for download. The author recommends that readers carefully read and understand ASHE disclaimer at the bottom of the page.

• ASHE’s 1135 Waiver Template
• ASHE’s Waiver ITM Recommendations Table

ASHE’s Waiver ITM Recommendations Table is comprehensive. The author also recommends that healthcare organizations using the ASHE table perform a risk assessment to review any intended changes to mandatory inspection, testing or maintenance requirements.  Some ITM changes may be riskier than others in certain healthcare facilities and could have undesired negative consequences.

Although the CMS Regional Office has the final approval for requested 1135 Waivers, that process can only start after CMS Regional Office approves the healthcare organization’s 1135 Waiver request.