Human Gene Therapy Subcommittee - 11/21-22/91 
Dr. Leventhal commented on the issue of insurance coverage for the bone marrow 
transplant procedure. The standard practice in the U.S. is that if insurance companies 
do not cover bone marrow transplants, patients do not receive them unless funds are 
raised by alternative methods. The majority of insurance companies currently cover the 
cost of bone marrow transplantations for acute myelogenous leukemia (AML). Ms. 
Meyers said she was concerned that insurance companies may disqualify payment 
because this protocol is experimental and not a standard therapeutic procedure. Dr. 
Leventhal stated that the insertion of a marker gene should not justify refusal of payment 
of transplants by insurance companies. The only additional payment required by the 
patient should be the cost associated with the gene marking procedure. Ms. Meyers 
asked what the difference in payment procedure is between Dr. Cometta's protocol and 
the previously approved protocol submitted by Dr. Brenner? Dr. Leventhal explained 
that there were no cost concerns with Dr. Brenner's protocol because the patients are 
being treated at St. Jude Children's Hospital in Tennessee. Because St. Jude raises the 
funds to cover the cost of transplant by telethons and donations, insurance coverage is 
not required. Dr. Parkman said that insurance companies routinely cover the cost of 
bone marrow transplants; however, the costs associated with research-related procedures 
are generally covered by the institution. Ms. Meyers noted that Indiana University is not 
going to cover any additional research related costs. 
Mr. Capron noted that the investigators have clearly explained that patients may receive 
therapeutic treatment without participating in the gene marking protocol. However, 
there is concern regarding payment for research related injury. The patient cost section 
states, "Unfortunately, some insurance companies may refuse payment for all medical 
costs incurred while a patient is involved with a research study." The patient needs some 
quantitation of what the extra costs will be and how to distinguish between the costs 
associated with gene transfer and costs relating to unforeseen medical illnesses resulting 
from other aspects of the experimental procedure. Patients may be also required to 
cover additional unspecified costs. It is unclear whether these are costs associated with 
complications or for additional materials. These cost issues should be separated in the 
informed consent document. 
Dr. Leventhal stated that the investigators must decide if there will be additional 
procedures that are not considered as part of the routine physical care. This issue is 
separate from injury costs. If additional procedures will be required, how will the costs 
associated with these procedures be covered? If patients are required to pay for both 
the costs associated with additional procedures and research-related injury, the patients 
should be informed that the risk of injury is very low. Mr. Capron asked if the language 
regarding patient cost is required by Indiana University's IRB. Dr. Cometta answered 
that it is required language. 
Ms. Meyers stated that the researchers should not expect health insurance providers to 
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