The Office of Certificate of Need and Healthcare Facility Licensure in the Division of Certificate of Need and Licensing in the Health Systems Branch of the New Jersey Department of Health (Department) is proposing to readopt, amend, repeal and issue new rules governing Standards for Certificate of Need Application and Review Process at N.J.A.C. 8:33. The proposed rulemaking regulates the process by which interested parties may apply for a certificate of need to obtain a license to operate certain health care facilities and services that require such certification from the Department.
The Department has reviewed the rules of this chapter and has determined this readoption is necessary, reasonable, and proper to maintain the regulatory framework known as the certificate of need process, which assures access to, and quality of, health care services for certain health care facilities and services in accordance with the Health Care Facilities Planning Act (N.J.S.A. 26:2H).
The Department is proposing to amend the demonstration project subsections that would delete rules governing the Atlantic Cardiovascular Patient Outcomes Research Team trial, inner city cardiac satellite demonstration projects and bloodless surgery demonstration projects because they are no longer in effect or were expected to be closed by the end of 2014.
The Department is proposing to establish a State elective angioplasty demonstration project that includes specific requirements for hospital participation. As proposed, eligible hospitals may continue elective angioplasty without on-site cardiac surgery backup by submitting to the Department an application for certificate of need under expedited review within 30 days of the effective date of the rule.
The State demonstration project isexpected to last eighteen months, but will continue until the promulgation of new rules at N.J.A.C. 8:33E that establish minimum standards for hospitals performing elective PCI without cardiac surgery backup, and the issuance of licenses under those rules. The results of the State demonstration project would assist the Department in establishing minimum standards for hospitals performing elective PCI without on-site cardiac surgery backup.
The Department also is proposing amendments to provide a link to the Department's website to obtain the full and expedited review certificate of need application forms. The proposed amendments also would require the submission of certificate of need applications in electronic media in addition to the paper copies that already are required.
The Department is proposing to repeal Appendices B, C, D and E and replace them with new rules at Appendices B, C, D and E that would contain new CN-1, CN-3, CN-4 and CN-19 forms, respectively. In addition, the Department is proposing to delete the "Attachments Checklist" from the new CN-19 form and intends to create a new checklist that would be available on its website with other certificate of need materials.
A notice of proposal appears in the February 2, 2015 issue of the New Jersey Register. Interested individuals may gain free on-line access to the New Jersey Administrative Code and the New Jersey Register at http://lexisnexis.com/njoal, courtesy of LexisNexis®.
The Department will accept written comments on the proposal during a period of public comment, which begins on February 2, 2015 and ends on April 3, 2015. For electronic submission, please go to http://www.nj.gov/health/legal/ecomments.shtml
and follow instructions for filing an official comment no later than April 3, 2015. Address regular U.S.P.S. mail to: Joy L. Lindo, Director, Office of Legal and Regulatory Compliance, New Jersey Department of Health, PO Box 360, Trenton, NJ 08625-0360: Address correspondence sent by Courier or Hand Delivery Service to: Joy L. Lindo, Director, Office of Legal and Regulatory Compliance, New Jersey Department of Health, 369 South Warren Street, Trenton, NJ 08608. All hard copy correspondence must be marked as having been received by the carrier of record on or before April 3, 2015. The Department does not accept facsimiles as official comments on the notice of proposal.
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