Holy Name Press Releases

New Jersey Supreme Court Ruling Enables NJDHSS to Prevent Gap in Ongoing Angioplasty Project

November 29, 2007

The New Jersey Supreme Court today issued a ruling that will allow nine New Jersey hospitals, including Holy Name Hospital, to continue uninterrupted participation in an important elective angioplasty demonstration project by extending the time within which the state's Department of Health and Senior Services must promulgate revised regulations, and issue new certificates of need and licenses. The multi-state project is being conducted by Johns Hopkins, and is designed to compare outcomes of patients treated with elective angioplasty at hospitals with cardiac surgery on-site to hospitals that have off-site cardiac surgery back-up.

Virtua Health filed a motion on September 10 requesting that the Court extend the deadline mandated by the Court's May 31, 2007 ruling in order to provide the state's Department of Health and Senior Services the time necessary to comply.  Today's court ruling grants Virtua's motion.

The Court's May 31 order required the Department of Health and Senior Services to revise its existing regulations to eliminate conflicts in the rules that govern the project. The Court provided that the nine participating hospitals could continue performing elective angioplasty for six months until new regulations and licenses were in place.

In its September 10 motion, Virtua contended that the November 30 deadline did not provide sufficient time for NJDHSS to complete the processes required to allow the project to continue without interruption.  Today's ruling emphasizes that the Court's prior ruling was concerned with the administrative process and not the safety of the study.

"We have always believed that the Court intended to allow the Department to move forward so that the elective angioplasty demonstration project could continue uninterrupted," said Richard P. Miller, President and CEO, Virtua Health.  "This case was never about patient safety.  If it were, the Court would never have allowed the study to continue."  

Commissioner of Health and Senior Services Fred Jacobs, M.D., J.D., approved the participation of the nine New Jersey hospitals in the elective angioplasty demonstration project on October 31, 2005. All of those hospitals have had their programs licensed and in operation for a year or more. "We commend Commissioner Jacobs for his unwavering support for New Jersey's participation in this important multi-state study," added Miller.

According to the Department of Health and Senior Services, participation in the demonstration project is important so that the state can best determine how to respond to the public interest in expanding the availability of elective angioplasty, which is increasingly the preferred treatment over heart by-pass surgery.

In response to the Court's order, the Department developed the required new regulations. On November 15, the Health Care Administration Board (HCAB) voted to approve the revised regulations for final adoption, and the revised regulations will become effective upon publication in the New Jersey Register on December 17, 2007.

Because of the Court's November 30 deadline, this would have resulted in a period of at least 17 days during which participating hospitals would be precluded from performing elective angioplasty procedures or continuing to treat patients who underwent the procedure at their hospitals previously.  In addition, the Court ruled that the Department must reissue new certificates of need and licenses after the regulations are adopted, a process which could require an additional six months, thereby lengthening a potential gap in the project.

Through today's ruling, the Court modified its deadline to enable the Department of Health and Senior Services to develop the necessary regulations and allow for the continuation of existing licenses until the Department can reissue new licenses.

New Jersey is responsible for more than 30 percent of the demonstration project's volume, making the state's ongoing participation vital to the study's integrity and timely completion.

The hospitals participating in the demonstration project are: Bayonne Medical Center, Holy Name Hospital, Monmouth Medical Center, Muhlenberg Regional Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital Hamilton, Somerset Medical Center, Trinitas Hospital and Virtua West Jersey Hospital Marlton.  All eight of the other participating hospitals have expressed support for Virtua in filing its motion.