Warning: Despite Blanket Waivers, CoP, EMTALA Regulations Are Still in Effect

By A.J. Plunkett

Beware the myths and misperceptions going around about the blanket 1135 waivers issued by CMS to facilitate care for the growing COVID-19 patient population, cautions healthcare regulatory attorney Delphine O’Rourke, JD, former counsel for the Ascension health group and now a partner at the Duane Morris law firm in Philadelphia.

The blanket waivers were issued for the national emergency declared by the president, retroactive to March 1, to empower healthcare providers to take needed actions and to provide flexibility when preparing and caring for COVID-19 patients.

Some of the waivers ease requirements under certain Conditions of Participation (CoP), while others remove barriers to moving patients and partnering with other organizations. However, the blanket waivers do not mean that all the CoP are suspended or that the Emergency Medical Treatment and Labor Act (EMTALA) regulations do not apply for now, warns O’Rourke.

Many of the waivers are contingent on whether a provider is in a region with a specific number of COVID-19 patients in your region. Others may be superseded by your local or state laws and regulations, she says.

The blanket waivers in all cases will only last as long as the national emergency, says O’Rourke.

When and if you are changing policies and procedures based on the blanket 1135 waivers, she recommends that you:

• Make it obvious what the changes are—use capital letters, red type, or however you want to highlight changes so personnel are clear on what they can and cannot do.
• Educate staff on the changes. However, remember that not all staff need to be aware of all the changes. Target your education.
• State clearly why you made the changes and what medical or evidence-based guidance was used to make the revision.
• Also state when they are to be in effect.
• Note when the changes were made because you will have to revert to the old policies and procedures at some point in the future.

There has been speculation that many of the changes may become permanent, but that will have to be done by legislation or regulatory changes, following the normal process of creating those revisions, she warns.

Also, keep those temporary policies and procedures on file, advises O’Rourke. You may be asked to defend the changes or account for actions taken after the national emergency lifts. The waivers do not mean you won’t be investigated or held accountable for patient safety, she says. You need to be able to show you were making a good-faith effort to protect patients and use the blanket waivers as they were intended.

A.J. Plunkett is editor of Inside Accreditation & Quality, a Simplify Compliance publication.