SAN DIEGO--For hospitals that haven't already established a hematopoietic stem cell program, Bruce E. Hillner, MD, advises them not to do so. "If you don't have a program now, buy the services elsewhere. That is a much smarter way to go," said Dr. Hillner, associate professor of medicine, Medical College of Virginia, Richmond.
SAN DIEGO--For hospitals that haven't already established a hematopoieticstem cell program, Bruce E. Hillner, MD, advises them not to doso. "If you don't have a program now, buy the services elsewhere.That is a much smarter way to go," said Dr. Hillner, associateprofessor of medicine, Medical College of Virginia, Richmond.
Dr. Hillner, whose research in the 1990s has focused on the costeffectiveness of various cancer treatments and patterns of cancercare, spoke at the Eighth Annual Cancer Care Symposium, sponsoredby the Society for Ambulatory Care Professionals and Health TechnologyAssessment of the American Hospital Association.
"I suggest that your centers not put capital into the bricksand mortar of a stem cell center. You should focus instead onthe framework of agreements and patient protocols," he advised."Focus on access to services versus delivering these services."
He recommends that institutions negotiate for stem cell serviceswith programs that are already well entrenched, using access tonational oncology trials as a quality indicator.
Dr. Hillner further suggested that there is no need for any newallogeneic centers in North America and "infrequent windowsof opportunity" for new autologous transplant centers. Anew autotrans-plant center would only be feasible in an area wherethere is little managed care, little contracting or dialogue betweenmedical centers, and an underutilized blood bank, he said.
Dr. Hillner noted that health insurers are less likely now toraise their eyebrows toward high-dose chemotherapy/transplantationand today rarely invoke "experimental" exclusion whenreviewing a case.
Nonetheless, he said, "I would guess that 20% to 40% of transplantsto support high-dose therapy are being done on incredibly shakyground." He has seen cases where the chances for benefitingfrom transplant were "infinitesimal at best."
Dr. Hillner also advised hospitals that have stem cell transplantprograms to prepare for more scrutiny because of efforts at standardizingregulations. He made note of a major report in draft form thatis to be published by the Foundation for the Accreditation ofHematopoietic Cell Therapy.
The impetus for the report has been a lack of accountability ofthese programs, as well as a preemptive move against federal regulations."This has been the Wild West; there has been no oversight,"Dr. Hillner said. "The oversight has been your mortalityrate, essentially."
The Foundation's report builds upon proposals issued in 1990 bythe American Society of Hematology. Some of the hurdles will beeasy to jump, he said--for instance, designing a unit with atleast two beds--while others might prevent some institutions fromever getting into the field.
The report recommends, for example, that programs maintain a volumeof 10 to 20 patients a year. "If this becomes a requirement,"he noted, "many smaller programs would have to consolidate."Even so, he calls the recommended patient volume threshold "shockinglylow." He believes that the minimum critical number is closerto 50 patients a year.
Another potential problem for many free-standing community institutionswould be the requirement for on-site radiotherapy. Programs alsowould be required to hire a program director with specific trainingin transplants.
The main area for regulation remains the cell processing and collectingitself, he emphasized. Some institutions will find quite onerousthe requirement for 24-hour blood bank support, he said, as wellas the level of apheresis experience and the extensive requirementsfor cell manipulation, storage, and monitoring.
"If you don't have a first rate local blood bank, don't eventhink about establishing a stem cell collection program,"Dr. Hillner said. "If you already have a program and yourblood bank is second rate, you're going to have trouble."