ARTICLE
21 December 2023

Two Executive Orders Revoke Temporary COVID-19 Waivers

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Riker Danzig LLP

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Riker Danzig LLP has served the business community for 140 years, with offices in Morristown and Trenton, New Jersey and in Midtown Manhattan. Riker Danzig is regional counsel, national defense counsel, and deal counsel to clients ranging from Fortune 500 corporations to middle-market businesses.
In November 2023, the Commissioner of the Department of Health ("Commissioner") published two notices of revocation ("NOR") of temporary rule waiver/modifications pursuant to Executive Orders...
United States Food, Drugs, Healthcare, Life Sciences

In November 2023, the Commissioner of the Department of Health ("Commissioner") published two notices of revocation ("NOR") of temporary rule waiver/modifications pursuant to Executive Orders ("EO") Nos. 103, 281, and 292. These NORs revoked partial waivers of flexibilities that had existed during the COVID-19 pandemic.

Revocation of Flexibilities for Opioid Treatment Programs

The Commissioner, through 55 N.J.R. 2229(a), revoked waivers regarding take-home medication dosage schedules, extended take-home medication, and take-home dosing and delivery guidelines in response to COVID-19. The provisions at N.J.A.C. 10:161B-11.12(a)vii and N.J.A.C. 10:161B-11.13(a)5 allowing Opioid Treatment Programs ("OTPs") to follow take-home dosing and delivery guidelines at N.J.A.C. 10:161B, Appendix C are no longer in effect. Thus, OTPs no longer have the flexibility with regard to take-home medication procedures.

The Commissioner reasoned that after due consideration, the Department of Health determined that the temporary rule waivers/modifications should be revoked because they are no longer consistent with federal guidance governing the provision of services by OTPs because the Substance Abuse and Mental Health Services Administration (SAMHSA) issued superseding, temporary guidance in April 2023, "Methadone Take-Home Flexibilities Extension Guidance."

The full text of the Notice of EO rule may be accessed here.

Revocation of Flexibilities for Long-Term Care Facilities, Assisted Living, Dementia Care Homes, Home Health Agencies, Hospice Care, Residential Health Care Facilities, and Ambulatory Care Mobile Vans

The Commissioner published 55 N.J.R. 2229(b), which revokes the waivers/modifications to regulations that were effective through EO Nos. 103, 281, and 292. The revocations are effective February 4, 2024. These waivers involved telemedicine. The provisions at N.J.A.C. 8:39, 8:36, 8:37, 8:42, 8:42C, 8:43, 8:43A-23.3, allowing flexibilities related to telemedicine for long-term care facilities, assisted living facilities, dementia care homes, home health agencies, hospice care, residential health care facilities, and ambulatory care mobile vans, will no longer be in effect as of February 4, 2024.

The Commissioner reasoned that after due consideration, the Department of Health determined that the temporary rule waivers/modifications should be revoked as they are no longer necessary, and enforcement of the rules in their original form would no longer be detrimental to the public.

The full text of the Notice of EO rule may be accessed here.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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