IMPORTANT NEWS
UPDATE:
New Jersey Supreme Court Ruling Enables NJDHSS to Prevent Gap
in Ongoing Angioplasty Project
Marlton, NJ – November 29, 2007
– The New Jersey Supreme Court today issued a ruling that will
allow nine New Jersey hospitals 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.
Because Virtua was the only one of the nine participating hospitals
that was a party to the Supreme Court proceeding, Virtua’s counsel,
Philip Lebowitz and Erin Duffy of Duane Morris LLP, filed the
motion on behalf of all nine hospitals.
Three South Jersey hospitals – Cooper University Hospital, Lourdes
Medical Center, and Deborah Hospital – appealed the Commissioner’s
approval in an attempt to stop the demonstration project. Those
three hospitals took their appeal all the way to the New Jersey
Supreme Court.
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.
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