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Our attorneys stay on top of changes in legislation, agency regulations, case law, and industry trends—then craft timely legal alerts to keep clients up to date on legal developments important to their business.

March 8, 2021

Emergency Amendment to Informed Consent Process for the COVID-19 Vaccine for Individuals in OPWDD Residential Facilities

Caregivers, family, and residents of OPWDD residential facilities have been significantly impacted by the COVID-19 pandemic. Efforts to limit the spread of the virus within these facilities have resulted in curtailed visits and interactions with family members and other supportive providers. Additionally, many residents have ancillary health conditions or other issues that leave them particularly vulnerable to negative outcomes from COVID-19.

The FDA approval and emergency authorization of several COVID-19 vaccines is a light on the horizon for many of these residents as well as their families and caregivers. On December 11, 2020, NYS Governor Cuomo and the NYS Department of Health announced the COVID-19 vaccine would be available to residents and staff in residential facilities certified by the NYS Office for People With Developmental Disabilities (OPWDD) as part of the initial phase of the COVID-19 vaccine program.

On December 30, 2020, the NYS OPWDD released interim guidance on administering the vaccine to residents in residential facilities certified or operated by the NYS OPWDD. Like other medical treatments and procedures, administration of the COVID-19 vaccine will require informed consent from the individual, but many individuals residing in residential facilities are unable to provide this consent. For those individuals unable to give informed consent for medical treatment, 14 NYCRR §633.11 provides a list of authorized surrogate decision makers. Generally, the regulation provides that actively involved family members or a lawfully appointed guardian can provide the informed consent for the resident. For those individuals who lack a designated surrogate decision maker or a formal guardian, the regulations provide for the use of an Informed Consent Committee (ICC) to provide consent.   

An emergency regulation was issued on December 29, 2020, as part of the emergency response to the pandemic that amended 14 NYCRR 633.11 to temporarily allow residential providers to convene an ICC for the limited purpose of obtaining consent to the COVID-19 vaccine for those individuals unable to provide informed consent and lacking a surrogate decision maker. As part of this emergency amendment, the requirement that the ICC include at least one person who does not serve on the behavior plan committee that reviews the resident’s behavior support plan has also been waived. The interim guidance explains that consent to a vaccine is unrelated to an individual’s behavior plan. Additionally, given the urgency of the vaccine distribution, the NYS OPWDD is urging the ICCs to complete their reviews and issue determinations within five days of the receipt of a referral packet, although this is not a formal requirement. The interim guidance also sets forth what items should be included in the referral packet for the ICC to review informed consent for the vaccine. That list can be found at the NYS OPWDD website.  

As emergency regulations and amendments continue to be issued in response to the pandemic, we at Barclay Damon are ready to assist our clients as they navigate through these unprecedented times.

If you have any questions regarding this alert, please contact Lisa Arrington, partner, at larrington@barclaydamon.com; Jim Grossman, partner, at jgrossman@barclaydamon.com; Bridget Dehmler, associate, at bdehmler@barclaydamon.com; or another member of our Elder Law & Medicaid Planning or Health & Human Services Providers Teams.

We also have a specific team of Barclay Damon attorneys who are actively working on assessing regulatory, legislative, and other governmental updates related to COVID-19 and who are prepared to assist clients. Please contact Yvonne Hennessey, COVID-19 Response Team leader, at yhennessey@barclaydamon.com or any member of the COVID-19 Response Team at COVID-19ResponseTeam@barclaydamon.com.

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