Washington state regulators are considering certificate-of-need rule changes that, among other things, would eliminate the requirement that hospitals must have an open-heart surgery program in order to offer heart-catheterization treatments.


That has some in the health-care industry worried that patients who undergo whats called interventional cardiology, such as angioplasty and placement of balloon stents, might be at risk if complications arise during the procedure and open-heart surgery isnt available on site to correct the problem.


The medical literature is pretty clear on this, and so is Medicare reimbursement, says Skip Davis, CEO of Providence Health Care here, which operates a host of hospitals in the region, including Sacred Heart Medical Center and Holy Family Hospital. It says that the incidence of problems is higher when you dont have the ability to back up the angioplasty with surgery.


Davis adds that manufacturers of stents specifically warn that such artery-opening devices shouldnt be installed unless heart-surgery capabilities are available on site, and that Medicare wont reimburse for angioplasty unless they are. That should tell you something, he says.


The Washington state Department of Health has published a couple of drafts of the proposed changes this year. Over the next month or so, it will decide what its next step will be, which could be to formalize its proposed rules then launch a comment period and hold hearings, says Gary Bennett, the departments director of facilities and services licensing.


The proposed rules still could change before that formal process begins, he says, adding, Its attracting a lot of attention.


The department wrote the proposed rule changes in response to a measure passed by the 2000 Washington Legislature that directed the department to modify its certificate-of-need criteria to help provide better access to coronary care in less-populated areas of the state.


The most controversial part of the proposed changes would allow hospitals to provide elective adult angioplasty procedures without having an approved open-heart surgery program in place, as the rules currently require. That current rule stems from the notion that if something goes wrong during an angioplasty-type procedure, heart surgeons should be ready to step in to save a patients life, industry observers say.


Hospitals without heart surgery programs currently are allowed to perform angioplasty in emergency situations.


Under the proposed rules, a hospital could be approved to offer angioplasty procedures as long as it arranged in advance to be able to transfer a patient, if a complication arose, to a hospital that did have a heart surgery program. The hospital to which the patient would be transferred would have to be located within two hours away, ensuring what the rules describe as safe and swift access to emergency heart surgery services.


Some in the industry say thats too long for a patient to wait.


In a letter to the Department of Health opposing the proposed rule changes, Spokane cardiologist Dr. Michael Ring wrote, By any standard of appropriate cardiovascular care, two hours is entirely an unacceptable delay and will clearly result in loss of life and heart function.


St. Mary Medical Center, in Walla Walla, is an advocate of the rule changes. Its president and CEO, John Isely, contends that the state concluded from studies and advisory group input that less than 1 percent of patients who undergo heart catheterization end up being transferred to an operating room for emergency heart surgery.


With this information, it was determined that there are actually significantly more patients who are dying or receiving suboptimal care from lack of timely access to interventional services than there are patients who require immediate access to the operating room from the cath lab.


In addition to clinical care issues, some hospital officials also worry that, rather than improving access to care in rural areas, the new rules instead would make it easier for for-profit specialty operators to begin offering such coronary care in urban areas, skimming off one of the more lucrative services from larger hospitals that must provide all types of care.


Yes, there is a serious concern about the proliferation of cath labs in the urban community, says Davis. We rely on cardiac business and other profitable businesses to support other programs that arent profitable and to make up for people who cant afford to pay.


Society, he contends, expects that full-service hospitals act as safety nets in a community, providing all types of care, including those they lose money on, as well as providing charity care. The idea of specialty for-profit hospitals coming in and choosing only to offer the profitable services would impact how the bigger hospitals could provide that safety net.


Im all for competition, as long as its on a level playing field, Davis says. If someone wants to come in and operate with the same rules and limitations I have, I say, Bring it on.


The proposed rules do include clauses apparently intended to prevent a new angioplasty program from putting an existing program out of business. A hospital wouldnt be granted a certificate of need to provide such services if doing so would reduce the annual volume of another hospitals program below 200 procedures, or if it would reduce the annual volume at a hospital located within 50 miles to below 400 procedures.


Hospital lobbyists suggest that the proposed rules wouldnt end up helping provide better access to coronary care in rural areas anyway, because cardiologists and hospitals there would have a difficult time finding medical malpractice insurance to provide services that medical literature and device manufacturers warn is risky.


Davis adds another factorthat the cost of setting up an interventional cath lab can run as high as $2 million, and that the low patient volumes a rural center likely would have would end up pricing the cost of the procedure too high.


Still, Davis and others argue that patient outcomes are the most important factor, and that statistics show hospitals that do higher volumes of a procedure tend to have better outcomes.


Wrote Ring in his letter to the Department of Health, Perhaps the core of this debate boils down to the issue of how much should the quality of care be compromised to facilitate increasing access. The first caveat of medicine is Do no harm. The DOH appears to be in a rush to alter the paradigm of cardiovascular care in the face of overwhelming evidence that doing so in the proposed manner will lead to tragic, preventable complications and deaths as well as cripple existing centers of cardiac excellence.