Each year, hundreds of thousands of surgical procedures are performed as same-day surgeries in the state's more than 300 outpatient surgery centers, a growing list of procedures that includes spine, joint, and bone operations; cataract surgery; plastic surgery; dental implants; and colonoscopies. The state Department of Health licenses hospitals and multiroom ambulatory surgery centers (ASCs), but it doesn't license single-room surgical practices housed in a doctor's office. They come under the purview of the state Board of Medical Examiners, which licenses doctors. But that could change during the lame duck session of the state legislature: on Monday, the Assembly Health Committee will hold a hearing on a bill to make all surgical facilities subject to uniform licensing by the health department.
The New Jersey Hospital Association supports the bill, which passed the Senate in June. It will "finish the process of leveling the playing field between ASCs and hospitals," said Kerry McKean Kelly, spokesperson for the NJHA.
Assemblyman Herb Conaway Jr. (D-Burlington) chairs the Assembly Health and Senior Services committee. Conaway is both a medical doctor and a lawyer, and he is the prime sponsor of bill A4099, which extends state health department authority to one-room surgical centers. He said he wants this legislation passed and sent to Gov. Chris Christie during the lame duck session.
"We want to take action to tighten up the regulatory environment around the one-room surgery centers," Conaway said. "As matters have evolved, we have seen that there are more complicated procedures being done outside of the hospital, and we want to make sure that those procedures are done in settings that are appropriate." He said the bill does not "unduly interfere with the practice of medicine, but provides as safe an environment that we can for patients. That is what we are trying to achieve."
The legislation is backed by the New Jersey Association of Ambulatory Surgery Centers (NJAASC) and the Medical Society of New Jersey. Physicians who operate surgical practices, meaning they perform surgery in a single room in their office, will continue to do so under this law, but they will be licensed by the health department. Right now, the department inspects both ASCs and surgical practices, but doesn't license the latter, which are certified by the Centers for Medicare and Medicaid Services.
Jeffrey Shanton, chair of the advocacy and legislative affairs committee of the NJAASC, said he is optimistic that having the health department license every venue where surgery is performed will address safety concerns raised by a report on ASCs conducted earlier this year by the New Jersey Health Care Quality Institute. That study reviewed health department inspection reports on 91 multiroom ambulatory surgery centers and single-room surgical practices and found a higher rate of non-compliance with safety rules at the one-room surgical practices. Among the violations: failure to properly sanitize instruments; staff who lacked current licenses and credentials; lack of required emergency equipment and medications; and failure to properly track controlled substances like narcotics.
David Knowlton, president of the institute, said in his report "I would not advise any of my friends or family to have surgery or procedures done" at any surgical practice not licensed by the health department. He noted that the doctors and surgeons working in the one-room surgical practices are licensed to practice medicine, "but this should not be substituted for a facility's license to perform surgery."
"We want the state involved" in licensing all surgery facilities, Shanton said. "We want this bill passed. What we have here is a good piece of needed legislation."
ASCs are subject to an annual state gross receipts tax of 2.95 percent of revenue, up to $350,000. That assessment has never been imposed on the single-room surgical practices, because the assessment only applies to state-licensed ASCs and other freestanding medical facilities licensed by the state,such as MRI centers. Under the new legislation, single-room surgeries will continue to be exempt from the assessment. Shanton said there are about 230 ASCs and 100 single-room surgeries across the state.
Shanton said ASCs "are an efficient and safe" way to do surgery but their image was tarnished by the Knowlton report. "The only way to deal with this is to be completely above board. Patient safety is job one."
Sen. Joseph F. Vitale (D-Middlesex) wrote the legislation in the Senate and said the Knowlton report demonstrated that "there is an obvious need" for all surgery facilities to be regulated by the state health department. "Consumers should be assured that the state will do all it can to make sure they are safe."
Attorney Mark Manigan of Brach Eichler, who represents a number of ASCs, said "We need to even out this hodgepodge of regulations. The same standards should govern outpatient surgery regardless of where it is performed."
The new licensing regulations will not apply to dentists and oral surgeons who perform root canals, extract impacted wisdom teeth, and undertake other surgical procedures.