Vote on Expanding NJ Hospital Angioplasty Services, After Years of Talk

Lilo H. Stainton | May 13, 2019 | Health Care
Common procedure is lucrative and potentially lifesaving but it’s unavailable in less populated parts of state, except in emergencies

Interior of the catheterization lab at Hunterdon Medical Center
After nearly a decade of discussion, community hospitals are hopeful New Jersey will expand access to elective angioplasty, a common, lucrative and potentially lifesaving procedure that is permitted at only certain facilities.

The Assembly Health Committee is scheduled to vote today on a bill that would require the state Department of Health to approve applications from hospitals seeking to add non-emergency angioplasty services, if they meet certain requirements. Among other things, the facilities would need to have been performing the procedure at least 250 times a year on an emergency basis; plus, they must sign a formal agreement to transfer patients to a full cardiac-care center if something goes wrong.

Angioplasty involves inserting a tiny tube into a patient’s artery to diagnose or treat (or both) a blockage in order to reduce the risk of a heart attack or other cardiovascular problems. Hundreds of thousands of these procedures are done each year in New Jersey to identify, and address, potentially deadly conditions.

Under current New Jersey law, 29 hospitals — primarily larger facilities, located in the most populous 14 counties — are licensed to use angioplasty to diagnose and treat patients in both emergency or less-urgent elective situations.

Another 25 facilities — generally smaller, community hospitals in the seven less-populous counties — are permitted to diagnose arterial blockages; but they can only treat the issue when it is considered an emergency. Patients who do not face imminent danger must travel to one of the hospitals licensed to handle both in order to have an elective procedure.

Pushing state regulators

For years, a number of the community hospitals with emergency angioplasty approval have pushed state regulators to revisit this protocol, arguing that given medical advances, it makes no sense to force patients to travel to receive an elective procedure they could get done safely closer to home. In addition, the extra revenue from doing more procedures would benefit these facilities and the communities that depend on them, advocates for change argue.

“It is simply illogical that what we are allowed to do on an emergency basis and do well, cannot be done electively. It makes no sense and there is absolutely no legitimate reason to maintain the status quo,” said Leslie D. Hirsch, the interim CEO and president of Saint Peter’s Healthcare System, based in New Brunswick. “The time has come to take action.”

But other facilities, including Burlington County’s well-regarded and highly specialized Deborah Heart and Lung Center, have raised concerns about the impact of the bill, which was first introduced in its current form in April 2018, and had not yet received a hearing in either House. Surgeons who perform more procedures are better able to keep their skills sharp, studies show, and these hospital leaders said that expanding access to elective angioplasty will reduce the volume at some sites to dangerously low levels, a scenario they said could put patients at risk.

“Given the thoughtful manner in which the state has awarded elective angioplasty programs, every community has convenient access to elective angioplasty,” said Susan Bonfield, Deborah’s executive vice president of legal and regulatory affairs and general counsel, in prepared testimony. “No barriers, geographic or otherwise, exist for patients to timely and safely access elective angioplasty.”

In New Jersey, 18 hospitals — including Deborah — have long had a cardiac surgery designation, enabling them to perform angioplasty in all eligible patients; if anything goes wrong during diagnosis or treatment, these patients can be quickly transferred to the adjacent cardiac surgery suite for a more invasive procedure, if needed.

A landmark Johns Hopkins University study showed that, in some cases, angioplasty diagnoses and treatments could be done safely without a full cardiac surgery option in the same complex. Based on this research, in 2012 the DOH extended permission to 11 other New Jersey facilities to provide elective and emergency procedures as part of a demonstration project; the project is ongoing. Together with the 18 cardiac-care facilities, these hospitals comprise the list of 29 now permitted to provide both emergency and elective angioplasty.

Since then, hospitals like St. Peter’s and Hunterdon Medical Center — which are not part of the 29 sites permitted to handle both emergency and elective angioplasty — have urged state officials to reconsider and expand the system through regulation. But limited progress led them to push for legislative changes through a variety of bills introduced by local lawmakers from both political parties.

“The safety and effectiveness of providing elective angioplasty in hospitals without on-site cardiac surgery was scientifically proven via evidenced-based research a number of years ago, yet New Jersey still lags behind the rest of the nation,” Hirsch, from St. Peter’s said.

But Bonfield, of Deborah, suggested the results of the Johns Hopkins research, known as the C-PORT E trial, are being misrepresented. The study involved specific parameters, a limited group of low-risk patients, and long-term monitoring, she said, factors not considered in New Jersey’s legislative proposal.

“Deborah acknowledges that evolution in medical care occurs every day and that advancements in care should allow for changes in care setting,” she said. “However, the data gleaned from the C-PORT-E trial on the safety of performing elective angioplasty without onsite backup is not supportive of the deregulation contemplated in this bill.”

Updating the licensing laws

The latest version of the legislation (A-3769) is led by Assembly members Andrew Zwicker and Roy Freiman (both D-Hunterdon), and Joann Downey (D-Middlesex); a Senate version, sponsored by Sens. Joseph Vitale (D-Middlesex), the longtime health committee chairman, and Vin Gopal (D-Ocean), awaits a hearing.

The proposal would update hospital licensing laws to enable certain qualified hospitals, without cardiac surgery centers, to apply for the elective angioplasty designation and, if they meet the state requirements, forces the DOH to approve their applications. To qualify, facilities would need to have been doing diagnostic and emergency angioplasty for at least six months, with a volume of at least 250 patients a year. They would also need to maintain a 200 patient-per-year volume going forward to maintain the expanded license, the bill notes.

“Hunterdon Healthcare is hopeful that this pending legislation will bring us one step closer in providing our community elective angioplasty. We already are performing emergency angioplasty procedures safely and with great success,” said Hunterdon Healthcare president and CEO Patrick J. Gavin. “Our residents should have fair and equal access to critical preventive cardiovascular healthcare right in their community,” he said; the medical center spent $17 million to upgrade its angioplasty facilities several years ago but remains constrained in who it can treat.

While the bill calls for applicants to have in place an agreement with a full cardiac-care hospital, as a backup, it does not require a more extensive relationship — something envisioned in previous versions of the proposal — which raised concerns for some of the community hospitals involved. This bill, which debuted in late 2017, was championed by former Assembly Speaker Vincent Prieto and failed to gain traction.