NJ regs impose volume requirement for credentials
New standards threaten urban hospitals
Part of a new piece of legislation that went into effect in New Jersey in July is a requirement that each hospital wishing to be certified to perform heart bypasses must perform at least 350 a year, up from 250 under previous rules. In addition, surgeons now are required to perform at least 100 bypasses at each hospital where they practice to be credentialed. There were no volume requirements for physicians before that time. From a practical standpoint, the new requirement will have little effect on existing cardiology programs, because all but one (University Hospital in Newark) already do over 350 a year.
Proponents of certificate-of-need (CON) laws fear quality may suffer if the laws are rescinded or abridged. July’s legislation in New Jersey follows on the heels of the release of a report commissioned by the state in which researchers noted a clear connection between the volume of three surgical procedures performed at hospitals in the state and surgical success. The report focused on coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, and cardiac catheterization. (See three charts with statistics on those procedures, below right.)
The report’s authors — David B. Nash, MD, MBA, associate dean and director for health policy at Thomas Jefferson University in Philadelphia, and Ted Ackroyd, PhD, director of QuadraMedi Corporation, a Harrisburg, PA-area data analysis firm — suggested in the report that minimum volumes for hospitals could be raised to as high as 800 operations a year and that surgeons should be doing at least 125 bypasses annually. The study found that the risk of death decreased steadily as the volume of surgeries at centers increased. For example, according to the authors, a patient whose surgeon performed more than 126 bypasses a year was 3.1 times less likely to die than a patient whose surgeon did fewer operations.
Many other outcomes studies also have shown that quantity drives quality and that patients have better outcomes at hospitals that perform high volumes of procedures. In response to the accepted volume-outcome hypothesis, the states whose CON laws have been allowed to sunset or have been rescinded have stricter licensing procedures that increase their oversight of new services.
The legislation signed by New Jersey Gov. Christine Todd Whitman ended the requirement that hospitals win state approval to open pediatric and maternity wards and to expand other services such as ambulatory surgery and magnetic resonance imaging. CON laws are eroding in New Jersey, but they’re not gone yet; CON approvals still are required for cardiac surgery, organ transplants, neonatal intensive care, and other highly specialized services. A new state commission is studying whether state approval of CON should remain mandatory in those areas.
Suzanne Ianni, executive director of the Hospital Alliance of New Jersey in Trenton, says New Jersey is deregulating services in three phases. In the first phase, legislation states that the addition of certain services will no longer require a CON, but will be subject to licensure by the Department of Health and Senior Services. Those newly unregulated services include acute renal dialysis, magnetic resonance imaging, detoxification for drugs and alcohol, and ambulatory care. The intent of phase one is to deregulate services already under expedited review, says Ianni, and allow a quicker review time without public comment period.
Phase two provides that within 20 months of enactment, certain services will be exempt from CON requirements. They include obstetric and pediatric services, extracorporeal shock wave lithotripter, hyperbaric chamber, and positron emission tomography. The intent, says Ianni, is to look carefully at those services before deregulating them and strengthen their licensing standards. The third phase concerns big-ticket items that have a large impact on the state budget or are highly specialized, such as cardiac catheterization, organ and bone marrow transplant, and burn treatment. During that phase, a CON study commission will be set up to look at such expensive and specialized services to decide what to do with them, says Ianni.
CON’s special effect on urban facilities
Urban hospitals in New Jersey as well as in other states are opposed to easing CON requirements because these hospitals stand to lose patients and revenue if restrictions are lifted. Though suburban and rural patients appreciate the convenience of having special services close to home, "the Hospital Alliance of New Jersey feels strongly that CON is important for urban hospitals," says Ianni. "The state has placed tertiary services in urban hospitals, and they bring a paying patient base from the suburban areas. That money helps subsidize the care of uninsured patients and the underserved. Once you start replicating services in the suburbs, there’s no reason for patients to go to the urban areas."
Ianni points out that the benefit of CON laws is that the state has an opportunity to consider the need for new services before investments are made in them. Without regulation, she says, there would be a proliferation of unnecessary services, which would only add to health care costs. "There’s a direct correlation between volume and quality of care," says Ianni.
The open-heart competition in New Jersey has spurred a pilot program called the Inner City Cardiac Satellite Demonstration Project. Under the program, an inner-city hospital licensed to provide cardiac surgery will partner with a nonurban provider within its system and create a suburban or rural satellite. Revenues generated at the satellite must be plowed back into the urban provider. If the urban hospital’s volume slips more than 20% in a year, the satellite will be discontinued.
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