When Roanoke residents need a kidney transplant, the closest option is the University of Virginia in Charlottesville, a two-hour drive up interstates 81 and 64.
For patients in far Southwest Virginia, the trip is even longer. Carilion Clinic cited this geographical barrier as a key reason for proposing a kidney transplant program in Roanoke. But the initiative has hit a roadblock, with state health officials recommending denial of the application.
[Disclosure: Carilion is one of our donors, but donors have no say in news decisions; https://cardinalnews.org/how-were-funded/.]
The Virginia Department of Health’s Division of Certificate of Public Need cited concerns in its staff report and referenced a letter of opposition from the University of Virginia Medical Center to support its recommendation. The opposition letter outlined several arguments against the program, but focused largely on concerns that another kidney transplant center in close proximity to UVa would divert patients away from its program and asserted that geographical distance from a transplant center is not the primary barrier to kidney transplant care.
The Certificate of Public Need division oversees the approval process for introducing new health care-related services in Virginia. It’s designed to prevent unnecessary duplication of services and ensure that health care resources are distributed equitably throughout the state. The division reviews applications and makes recommendations to the state health commissioner, who makes the final decision.
Thirty-five states plus Washington, D.C., have Certificate of Public Need laws in place, according to the National Conference of State Legislatures.
The staff report from the Certificate of Public Need division called the proposal “premature,” following issues with the hospital’s surgical instrument sterilization processes.
“Although the facility is back in regulatory compliance, DCOPN concludes that it is too soon to embark on an undertaking as critical and sensitive to infection control as a transplant program,” according to the staff report.
After an anonymous complaint was filed with the health department in 2023, Carilion was found to be in “immediate jeopardy” of being in noncompliance with health and safety requirements put in place by the Centers of Medicare and Medicaid. The complaint alleged that a higher than normal number of surgical instruments were arriving in the operating room with blemishes.
The complaint prompted three unannounced inspections at the facility by VDH starting in September 2023. According to the report, staff said that, at times, dozens of surgical instrument trays were deemed unusable just before operations.
Carilion was required to take corrective action and establish new measures to address the concerns, and the VDH signed off on the plan in March 2024.
The report from the Division of Certificate of Public Need also raised concerns that Dr. Arnold Salzberg, who would be the primary surgeon leading the program, has limited experience in organ transplant procedures. The Organ Procurement and Transplantation Network sets national standards for kidney transplant procedures, and requires that the leading physician in a kidney transplant program demonstrate significant experience, typically requiring them to have been directly involved in at least one kidney transplant within the past two years, according to the network’s website.
Salzberg completed an organ transplant fellowship in 2007 at Virginia Commonwealth University, which is required by the network, but the last time he was involved in a transplant procedure was in 2009, according to the staff report. For the last 10 years, Salzberg has specialized in bariatric surgery at Carilion Roanoke Memorial Hospital and now serves as the director of metabolic and bariatric surgery.
Carilion recently recruited a second transplant surgeon, Dr. David Cronin, who is currently employed at the Salem Veterans Affairs Medical Center, said Carilion spokesperson Hannah Curtis.
Curtis confirmed last week that Salzberg would be the primary surgeon for the transplant program, and that Carilion will address the questions raised about his experience during an informal fact-finding hearing in January. Carilion requested the hearing to challenge the state’s recommendation to deny its application.
UVa’s opposition letter claims that the overlap in service areas between the two hospitals could pose significant risk to its own program, since Carilion would likely rely on diverting patients away from the Charlottesville program.
Carilion’s application stated that during its first year of operation, it expects to perform only 10 kidney transplants. Over time, it plans to increase to 30 transplants annually, the minimum required by the organ procurement network to ensure that surgeons maintain proficiency in performing these procedures.
UVa completes about 116 transplants annually, according to the staff report. It began its kidney transplant program in the 1960s.
Even though Carilion’s program would be much smaller than UVa’s, the university expressed concern that the change in patient volume would negatively affect its training missions, research initiatives and staffing, according to the staff report.
UVa’s kidney transplant program has six surgeons and eight transplant nephrologists, kidney specialists who manage care before and after a transplant, UVa spokesperson Eric Swensen said last week.
“UVA stands out in this field by attracting, training, and retaining a team of specialists specifically trained in the complexities of transplant care,” Swenson said in an email. “As one of only six transplant centers in the Commonwealth, UVA is uniquely positioned to deliver contemporary, specialized transplant care to a large volume of recipients. The specialized nature of transplant services limits the pool of qualified specialists, creating challenges in maintaining and expanding the skilled workforce essential for achieving exceptional patient outcomes.”
The university also stated that Carilion’s program at Roanoke Memorial would not improve geographic access to transplant procedures or to pre- and post- transplant services, citing its own outpatient clinics for transplant patients in Lynchburg, Martinsville and Roanoke.
Carilion, in its application, said that outpatient care would be available to transplant patients at its Roanoke campus. Eventually, the health system plans to open satellite clinics to expand access within rural areas of its service area.
UVa also said that the notion that distance to a transplant center is the primary barrier to transplant surgery is outdated. Instead, the biggest challenge is the availability of organs, it said.
“Carilion’s proposal, quite simply, fails to meet a public need,” the letter said.
In a response to UVa’s letter, Carilion cited the State Medical Facilities Plan, which says that transplant services should be accessible within two hours’ driving time to 95% of Virginia’s population.
Right now, about 92% of the population of Virginia has access to kidney transplant services within two hours, according to the staff report. The addition of Carilion’s program would increase access to about 97% of the population. The counties of Buchanan, Dickenson, Lee, Russell, Scott, Tazewell, Washington and Wise would still remain outside the two-hour standard.
The Division of Certificate of Public Need also received eight letters in support of Carilion’s proposal, including one from Virginia Commonwealth University, which runs a kidney transplant program in Richmond. There are six kidney transplant programs in Virginia: at Inova Fairfax Hospital, Henrico Doctors Hospital, Children’s Hospital of the King’s Daughters, VCU, Sentara Norfolk General and UVa.
VCU has agreed to support Carilion’s kidney transplant program by conducting the necessary organ compatibility testing.
The Division of Certificate of Public Need summarized key points from the support letters and included them in the staff report.
“Improving access to transplant services would be life-changing for the end-stage renal patients who are members of the CRMH community,” the staff report summarized from the support letters.
