As Landmark Medical Center prepares to defend its proposal to open a cardiac services center, state officials are considering new rules that would govern how such programs operate. The state Department of Health proposes to amend its regulations for the licensing of hospitals. In so doing, it proposes to set minimum numbers for the number of procedures that a cardiac program must perform each year to keep its license.
A 1996 state law authorized the department to create such standards for tertiary services in which evidence shows that the quality of patients’ outcomes is directly related to the number of procedures the program performs each year.
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Already, the department has set standards for neonatal intensive care units. Now, it is turning its attention to cardiac services. Actually, the effort has been going on for more than a year now, as an ad hoc “tertiary care” committee, made up of health insurers, health providers, and other interested parties, has been reviewing the medical literature to determine the appropriate number of procedures that cardiac programs should be required to perform.
The rules the committee proposes call for existing coronary angioplasty programs to perform at least 400 procedures per year. It also calls for proposed angioplasty programs to provide data that shows there can be a reasonable expectation of attaining and maintaining a “utilization rate” of 400 yearly angioplasty programs.
The new rules would also require existing coronary artery bypass graft surgical programs to perform at least 500 procedures per year. A new program would have to demonstrate that it would reach that level in three years.
Coincidentally, the proposal comes at the same time that Landmark Medical Center is proposing to open a new cardiac services unit at its Woonsocket site. It plans to partner with Boston’s Beth Israel Deaconess Medical Center to offer diagnostic catheterization, interventional catheterization, and open-heart surgery.
Diagnostic catheterization is the diagnosis of blockages within the heart. Interventional catheterization is removing blockages within certain arteries.
Two, full-time, resident surgeons from Beth Israel would be in charge of the program at Landmark. One or two cardiologists would also be stationed at Landmark.
Now, the only hospitals that offer cardiac surgeries are: Rhode Island, Hasbro Children’s, and Miriam Hospitals, all part of the Lifespan hospital network. The three hospitals perform 1,700 open-heart surgeries per year.
Lifespan is contesting Landmark’s proposal to open a new cardiac service, saying that Landmark would not be able to offer sufficient volume of services to create a quality program.
But in the application Landmark has filed with the Department of Health, it states that the cardiac services program expects to perform 420 angioplasty procedures by 2002, the second year of the program. That would put the center in line with the proposed state rules.
For open-heart surgeries, Landmark projects that it will have 250 procedures by the second year, 2002. As of March 15, however, it had not offered projections for the third year.
The decision on whether Landmark can go forward with its plans now rests with the health department’s Health Services Council. The council will make its decision after a series of public hearings in which both sides, Landmark and Lifespan, will present witnesses. Once the hearings are complete, an official record of the proceedings will be forwarded to the council members.
Once the council makes its decision, it will issue a recommendation to department Director Patricia A. Nolan, who will have the final say on Landmark’s proposal.
John Donahue, chief of health systems development for the department, said the question of whether Landmark will reach the appropriate volume of services by the third year will likely come up at the public hearings the department will conduct.
“It seems a natural question that’s going to come up in that ‘trial-like’ situation,” Donahue said.
Department officials expect to have the new rules governing cardiac services in place before any decision is made on Landmark’s proposal. But Landmark would have to comply their guidelines either way.
Don Williams, associate director of health services regulation for the department, said the department held an informal “community review” process on Monday, March 6 that allowed interested parties to comment on the proposed rules. In addition, it held a comment period that ended Wednesday, March 15. After reviewing the comments, the department will make any changes to the rules that it deems necessary. Then, the proposed rule will go through the formal rule-making process. The department will place an advertisement for the formal public hearing on the rules in the Providence Journal 20 days before the actual hearing, he said.
At the public hearing, interested parties will make their statements, which the department will record. After the hearing, the department allows two more weeks for additional comments to come in. Then, Nolan will decide whether to issue the regulation as it exists. If she decides that substantive changes need to be made, the department will have to conduct a new public hearing, Williams said.
All of this “happens to be occurring at the same time (of) the Landmark proposal,” Williams said.
The issue of how many cardiac services procedures it takes to ensure a quality program is the basis of Lifespan’s challenge to the Landmark proposal. Dr. Richard A. Hopkins, cardiac surgeon-in-chief for the three hospitals that perform open-heart surgeries, has said that the data on patient outcomes show that the best cardiac programs perform 600 or more open-heart procedures per year. Further, large programs are more likely to attract the most talented surgeons and researchers, and are more likely to have people on staff who are experienced in the specific services that individual patients need.
But the volume will be sufficient to form a high-quality program, said Dr. Stanley M. Lewis, associate chief for clinical cardiology at Beth Israel and an associate professor of medicine at Harvard Medical School. Lewis said that in the cardiac services center’s early stages, when the volume is low, the Beth Israel surgeons working in Woonsocket will also perform surgeries in Boston. This will keep the surgeon’s volume at a high level, he said.
As the Landmark center grows, the two surgeons will spend more and more of their time there, until the center reaches the point at which the two will do all their work there, Lewis said. The Boston Beth Israel cardiac unit performs 1,100 open-heart surgeries per year, he said. The Landmark surgeons will be members of the Cardiac Surgical Group at Beth Israel, he said.
”You want operators who have a high level of experience, and you want a program with a high level of experience,” Lewis said.
“You want operators who have a high level of experience, and you want a program with a high level of experience,” Lewis said. “This program will, in many ways, be able to take advantage of the experience of the program at BI Deaconess. It doesn’t need to reinvent systems; it can tap into a lot of expertise.”
Lewis added that he expects Landmark to be able to comply with whatever rules on volume of services that the state adopts.
”The intent here is to have a first-rate program with all guidelines being met – and most importantly excellent outcomes,” he said. “We’re confident this program will be a top notch one.”
