TRENTON — Stressing the need to maintain high quality cardiac surgery services in the state, Deputy Commissioner James S. Blumenstock today denied four hospitals’ applications to begin cardiac surgery programs.

 

Research has shown that programs that perform a large number of cardiac surgeries generally have significantly lower mortality rates. Since 2000, however, the volume of cardiac surgery statewide has declined, making it more difficult for hospitals and surgeons to achieve the volume that correlates with high quality.

 

Blumenstock, Deputy Commissioner for Public Health Protection and Emergency Preparedness, found there is no need at this time for any additional cardiac surgery programs either statewide or in the Union or Ocean county regions.

 

The four hospitals that applied for and were denied a certificate of need to start a cardiac surgery program are: Community Medical Center in Toms River (Ocean County call); Muhlenberg Regional Medical Center in Plainfield; Somerset Medical Center in Somerville (Somerset County) and Trinitas Hospital in Elizabeth (Union County call).

 

There are currently 17 cardiac surgery programs licensed and operating in New Jersey. There is another unimplemented certificate of need for a cardiac surgery program at Jersey City Medical Center, which is expected to become licensed later this year.

 

In September 2002, the department announced it would accept applications for new cardiac surgery programs in two regions: Union and Ocean and the counties surrounding each. The Department stated at that time that its action did not mean that the Department had concluded there was a need for any new cardiac surgery programs. The Department was responding to two separate petitions for a call for certificate of need (CN) applications.

 

Under state law, a certificate of need application should be approved if it “is necessary to provide required health care in the area to be served, can be economically accomplished and maintained, will not have an adverse economic or financial impact on the delivery of health services in the region or statewide; and will contribute to the orderly development of adequate and effective health care services.”

 

According to the two decisions, each of the four hospital applicants failed to demonstrate a regional need for a new cardiac surgery program in their region. The rulings were based on several complex factors:

 

• Research indicates that higher volume in a cardiac surgery facility translates into significantly lower mortality rates.

• Cardiac surgery volume in New Jersey is declining since a peak of 11,678 cases in 2000. Between 2000 and 2002, the statewide volume decreased by 5.6 percent. The addition of two cardiac surgery programs since 2000 has not increased volume statewide.

• Expert consensus is that the declining volume of cardiac surgery is the result of increasing substitution of coronary angioplasty, which uses a catheter threaded through a blood vessel in the leg to open a blocked coronary artery.

• Recent cardiac surgery literature indicates that cardiac surgery rates will decline significantly in the future due to the availability of drug-eluting stents approved by the U.S. Food and Drug Administration in 2003. These stents reduce the likelihood of the coronary artery closing up again and make more patients eligible for the less invasive angioplasty procedure over open heart surgery.

 

New Jersey is a national leader in efforts to improve the quality of cardiac surgery care. New Jersey is one of only four states to measure and report cardiac surgery outcomes and one of only two states to examine post-surgery 30-day mortality in a cardiac surgery report card.

 

Clifton R. Lacy, M.D., the commissioner of the Department of Health and Senior Services, delegated the certificate of need decision-making authority to Deputy Commissioner Blumenstock, a 30-year veteran of the department who oversees public health programs and terrorism preparedness and response.

 

Dr. Lacy requested advice from the Executive Commission on Ethical Standards concerning a decision related to the certificate of need applications. He requested the advice because of his affiliation with an affected facility prior to joining the department.

 

               The Commission ruled on November 25, 2003 that Dr. Lacy was required to delegate the decision-making authority in the case of the three Union County hospitals. Commissioner Lacy voluntarily delegated the decision-making authority in relation to Community Medical Center’s application.

 

The hospitals may appeal the ruling to the Office of Administrative Law.