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PCI Without Cardiac Surgery On Site
                               An Expert Panel Review
                                    Nov. 27, 2012


Good morning, thank you for joining us for what is sure to be a very informative day.
We are extremely lucky to have a distinguished group of experts here with us to present
on Elective Angioplasty without cardiac surgery on site. The Department’s
Cardiovascular Health Advisory Panel (CHAP) and the New Jersey Chapter of the
American College of Cardiology are the co-sponsors of today’s Statewide Symposium
and they did an excellent job ensuring that we had representation of the many view points
on this issue. This is an issue that crosses science, access to care and has a significant
financial impact on the industry. It is an important and controversial issue in our state and
it is critical that we make our decisions based on science and thoughtful dialogue. This
forum provides a great opportunity to learn about evidence-based science.

As you know Elective Angioplasty without on-site cardiac surgery has a long history that
has crossed over the tenure of several Commissioners. In 2004, the Department issued a
Certificate of Need (CN) call for applications to participate in the Atlantic C-Port-E
study. In Oct. 2005 CN approval was given to demonstration project hospitals, causing
some controversy which led to litigation. Following successful litigation that challenged
the Department’s CN process, in 2007 the Department adopted rules to clarify the
parameters of the demonstration project and issued another CN call. In 2008, CN
approval was granted to demonstration project hospitals, some of the original hospitals
continued to participate and also new ones were added. In August of 2011, the
Department adopted rules to allow demonstration project hospitals to continue to provide
elective angioplasty until 9 months following the publication of the study. And in May of
this year, the Atlantic C-PORT-E findings were published in The New England Journal
of Medicine by the trial’s principal investigator—Dr. Thomas Aversano and his
associates.

Last month in a letter to hospital CEOs, I explained that to properly develop state policy
regarding elective angioplasty additional time is necessary to allow the Department to
carefully evaluate the findings of the Atlantic C-PORT-E research study, assess the
impact of the elective angioplasty demonstration projects on existing cardiac surgery
centers and to solicit feedback from stakeholders—including the medical, quality care
and EMS communities.

Today is a first step in the process--today’s symposium will describe where we are now
with elective angioplasty and how this has developed over the years, explain the results
of the CPORT-E Trial and debate the clinical issues related to the provision of elective
PCI without cardiac surgery on site.

Early next year, the State Health Planning Board (SHPB) will conduct a series of
hearings throughout the state on elective angioplasty to allow for a public and transparent
discussion. These hearings will allow members of the public to share their thoughts on



                                                                                             1
how the state should move forward. Some topics for discussion at these hearings include
quality, policy, access and economic impact. All of this will inform the entire state as we
move forward and going through this process will help the Department develop
scientifically based statewide policy.

There have been many changes in cardiac services over time and I know friends and
family that have experienced those changes in cardiac care over a generation. No matter
where you stand on this issue—today you will hear science from experts that will inform
your understanding and perspective on this topic.

Thank you.




                                                                                          2

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Commissioner of health mary o'dowd

  • 1. PCI Without Cardiac Surgery On Site An Expert Panel Review Nov. 27, 2012 Good morning, thank you for joining us for what is sure to be a very informative day. We are extremely lucky to have a distinguished group of experts here with us to present on Elective Angioplasty without cardiac surgery on site. The Department’s Cardiovascular Health Advisory Panel (CHAP) and the New Jersey Chapter of the American College of Cardiology are the co-sponsors of today’s Statewide Symposium and they did an excellent job ensuring that we had representation of the many view points on this issue. This is an issue that crosses science, access to care and has a significant financial impact on the industry. It is an important and controversial issue in our state and it is critical that we make our decisions based on science and thoughtful dialogue. This forum provides a great opportunity to learn about evidence-based science. As you know Elective Angioplasty without on-site cardiac surgery has a long history that has crossed over the tenure of several Commissioners. In 2004, the Department issued a Certificate of Need (CN) call for applications to participate in the Atlantic C-Port-E study. In Oct. 2005 CN approval was given to demonstration project hospitals, causing some controversy which led to litigation. Following successful litigation that challenged the Department’s CN process, in 2007 the Department adopted rules to clarify the parameters of the demonstration project and issued another CN call. In 2008, CN approval was granted to demonstration project hospitals, some of the original hospitals continued to participate and also new ones were added. In August of 2011, the Department adopted rules to allow demonstration project hospitals to continue to provide elective angioplasty until 9 months following the publication of the study. And in May of this year, the Atlantic C-PORT-E findings were published in The New England Journal of Medicine by the trial’s principal investigator—Dr. Thomas Aversano and his associates. Last month in a letter to hospital CEOs, I explained that to properly develop state policy regarding elective angioplasty additional time is necessary to allow the Department to carefully evaluate the findings of the Atlantic C-PORT-E research study, assess the impact of the elective angioplasty demonstration projects on existing cardiac surgery centers and to solicit feedback from stakeholders—including the medical, quality care and EMS communities. Today is a first step in the process--today’s symposium will describe where we are now with elective angioplasty and how this has developed over the years, explain the results of the CPORT-E Trial and debate the clinical issues related to the provision of elective PCI without cardiac surgery on site. Early next year, the State Health Planning Board (SHPB) will conduct a series of hearings throughout the state on elective angioplasty to allow for a public and transparent discussion. These hearings will allow members of the public to share their thoughts on 1
  • 2. how the state should move forward. Some topics for discussion at these hearings include quality, policy, access and economic impact. All of this will inform the entire state as we move forward and going through this process will help the Department develop scientifically based statewide policy. There have been many changes in cardiac services over time and I know friends and family that have experienced those changes in cardiac care over a generation. No matter where you stand on this issue—today you will hear science from experts that will inform your understanding and perspective on this topic. Thank you. 2