Frustrated with the slow pace of regulatory change, leaders from a rural New Jersey hospital are seeking a legislative solution to increase access to angioplasty, a potentially lifesaving outpatient procedure to help prevent heart attack, stroke, and other cardiovascular trouble.
Representatives of Hunterdon Medical Center testified before the Senate health committee on Thursday, urging lawmakers to allow them to expand the work done in their cardiac catheterization practice to include elective angioplasty — a non-emergency treatment for blood-flow problems in an artery. Cardiovascular concerns are a leading cause of death in the Garden State, they said, and prompt treatment is critical to preserving health.
The group was joined by Sen. Christopher “Kip” Bateman (R-Somerset, Hunterdon) who introduced a bill that would require the state to license qualifying hospitals in five rural counties, including Hunterdon, that now lack local access to elective angioplasty; the measure was posted for discussion only. Bateman and others said the state Department of Health is also reviewing the current regulations on the practice, which they praised, but felt it was necessary to pursue multiple paths to reform.
The group noted that New Jersey was lagging behind the nation when it comes to improving access to this treatment. “Almost every other state in the country has long ago allowed elective angioplasty in community hospitals like ours,” said Dr. William Schafranek, an HMC cardiologist who leads the catheterization lab. “We’re now at least 10 years behind the times.”
Hunterdon Medical Center, the only acute-care facility in the rural county, has for years used the same procedures to diagnose cardiovascular problems and to treat artery blockages when the patient is facing an emergency. But physicians at Hunterdon, and at other community hospitals, are currently prohibited from treating non-emergency cases — even when they are the ones who discover the problem.
As a result, each year hundreds of patients diagnosed in Hunterdon are sent to Morristown Medial Center, nearly an hour away, which is one of 29 hospitals statewide permitted to perform elective procedures. And residents of six other rural counties — Cape May, Cumberland, Gloucester, Salem, Sussex, and Warren — face the same dilemma, with some patients forced to travel 90 minutes to reach a hospital that can perform the critical procedure when not an emergency.
(Hunterdon Medical Center officials testified that Bateman’s bill would apply to Cumberland, Hunterdon, Salem, Sussex, and Warren counties; it was not immediately clear why the other counties were not included.)
“I don’t think there is any issue more important to the citizens of Hunterdon County than this issue,” said Robert Wise, president and CEO of Hunterdon Healthcare, which runs the hospital. Cardiac diseases are “one of the leading causes of death in Hunterdon County and our population is aging,” Wise added, noting one in five residents was already over age 65.
Out of date
The current regulations are rooted in policies that reflect the higher risks involved with the procedure when cardiac catheterization was first developed, some 50 years ago. At first, regulators required the procedure be done only at facilities that had trained cardiac surgeons and a dedicated operating suite, among other resources. (Diagnostic cardiac catheterization involves threading a tiny tube into a patient’s artery and injecting dye so blood flow can be tracked; treatments include inserting a balloon to inflate the artery and, if needed, adding a stent to prop it open.)
But a landmark study of hospitals in 10 states — including 11 facilities in New Jersey — published in 2012 in the New England Journal of Medicine confirmed the risk associated with the procedure has dropped significantly. Many states used this as the basis for drafting new regulations that permitted more facilities to offer the elective procedure.
But New Jersey created a “demonstration project” that allowed these 11 hospitals to join a list of 18 facilities, with full cardiac surgery capabilities, already permitted to do non-emergency angioplasty. All of these are clustered in the state’s most populated 14 counties.
Schafranek, with Hunterdon Medical Center, said it’s time to update this policy. “Providing elective (angioplasty) without surgery is another step forward for the betterment of our patients. The science supports its safety,” he said.
Several other physicians, including Dr. Jack Dworkin, a cardiologist at CentraState Healthcare System in Monmouth County, eagerly supported Hunterdon’s call for more elective angioplasty options. “Who suffers most from these antiquated policies? Our patients, of course,” Dworkin said.
Sounding a warning
But Dr. William Hirsch, the attending cardiologist at Deborah Heart and Lung Center in Burlington County cautioned against allowing the procedures without full cardiac surgery backup. The real-life cases he has seen in New Jersey are more complicated than those included in the study that helped change these policies, he warned.
New Jersey’s demonstration project policy, which was extended in 2015, continues today, according to DOH spokeswoman Donna Leusner. A new rulemaking process was underway in February and Leusner said Thursday this would involve stakeholder meetings to inform the timeline of the process.
Wise, the Hunterdon CEO, said DOH told them a group of experts would be holding monthly meetings to discuss the “clinical aspects and risks associated” with updating the policy. “We were pleased the DOH commissioner was able to inform us of this change in frequency” at a recent meeting, he said.
The Bateman bill (S-2761) allows hospitals with specific qualifications, and in certain counties, to apply to the DOH for a license to provide elective angioplasty. It would only apply to facilities in counties with populations between 50,000 and 200,000 and that are not located on the Atlantic Ocean and those who can demonstrate “the ability to offer a high quality program” that is open to diverse members of the community. Hospital officials testified that it would apply to Cumberland, Hunterdon, Salem, Sussex, and Warren counties.
While the proposal received positive feedback from several members of the Senate health committee, others, including Sen. Richard Codey (D-Essex) raised concerns about circumventing the existing state licensing and regulatory process. Sen. Jim Whelan (D-Atlantic) wondered, “Are we opening a Pandora’s box type thing,” where hospitals with less experience would be seeking designations through legislation, instead of the existing state process. (Both Codey and Whelan stressed their comments did not suggest HMC was not a quality facility.)