New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

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On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding exemptions, and introducing a self-certification pathway for certain capital projects. The final rule is published in the New York State Register (Vol. XLVII, Issue 31, Aug. 6, 2025) and is available here.

New York’s CON program, authorized under Public Health Law Article 28, requires state approval before healthcare facilities can be constructed, expanded, or substantially modified. The process is intended to ensure that new projects address a demonstrable public need, are financially sound, and meet quality and safety standards. Historically, this framework applied even to relatively modest capital improvements, which could trigger the same lengthy review process as large-scale expansions.

Under the amended regulations, routine or non-clinical projects with a capital cost under $12 million may now qualify for limited review, written-notice only, or full exemption from CON oversight. Eligible construction projects costing up to $30 million may proceed under an architectural self-certification process in lieu of DOH review, reducing both approval times and administrative burden. The rules also require that multiple CON applications for a single project be submitted together, eliminating piecemeal review.

These changes do not apply to all project types. Projects involving clinical service changes, bed additions, or the establishment or re-establishment of operators generally remain subject to full review, regardless of cost. DOH has not yet issued formal transition guidance, but providers with applications currently under review may wish to evaluate whether the amended rules could apply to their projects and whether reclassification is possible.

Self-certified projects must still comply with all applicable state building codes, NFPA life safety standards, and federal requirements, including CMS Conditions of Participation where relevant.

In parallel, the Public Health and Health Planning Council (PHHPC) has initiated a separate review of the nursing home CON process, with a focus on ownership transparency, financial stability, and aligning bed capacity with demographic needs. That process may lead to further rulemaking affecting the long-term care sector.

New York’s reforms come amid a broader national shift toward modernizing CON laws. States such as Florida, Georgia, and Tennessee have also adjusted or repealed elements of their CON frameworks, aiming to reduce regulatory delays for lower-risk projects while retaining oversight for more significant proposals.

For stakeholders in New York, these amendments warrant a careful review of the updated thresholds, exemption criteria, and self-certification provisions. Projects involving clinical service changes, bed additions, or the establishment or re-establishment of operators generally remain subject to full review, regardless of cost, and should not assume eligibility for expedited treatment without confirmation from DOH. Understanding the scope and limitations of the new rules will be essential for ensuring compliance and effectively planning future capital projects.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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