The Office of Certificate of Need and Healthcare Facility Licensure of the Division of Health Facilities Evaluation and Licensing of the Senior Services and Health Systems Branch of the Department of Health and Senior Services is proposing amendments at N.J.A.C.  8:33-1.3 and 3.11, 8:33E-1.3 and 2.3, and 8:43G-7.28.  The proposed amendments would establish the certificate of need process and criteria for the continued participation of New Jersey licensed general hospitals, through a demonstration project, in the Atlantic Cardiovascular Patient Outcomes Research Team (Atlantic C-PORT-E) trial. The proposal appears in the August 20, 2007 issue of the New Jersey Register.

The Atlantic C-PORT-E trial is a multi-state randomized clinical trial of elective angioplasty or percutaneous coronary intervention in hospital settings with and without on-site cardiac surgery. The proposed amendments would respond to the recent decision of the New Jersey Supreme Court that found invalid the Department’s process for the issuance of certificates of need to perform elective angioplasty or PCI without on-site cardiac surgery backup as part of New Jersey’s participation in the Atlantic C-PORT-E trial.  Cooper University Hospital v. Jacobs, 191 N.J. 125 (2007).

The public has until October 19, 2007 to comment on the proposal.  Persons wishing to comment on the proposal must submit their comments in writing to John A. Calabria, Director, Office of Certificate of Need and Healthcare Facility Licensure, Division of Health Facilities Evaluation and Licensing, NJ Department of Health and Senior Services, PO Box 358, Trenton, NJ 08625-0358.  Written comments on the proposal must be postmarked on or before October 19, 2007, which is the close of the 60-day public comment period.