October 19,2005
October 18, 2005
Elizabeth M. Duke, Ph.D
Health Resources and Services Administration
Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Dear Administrator Duke:
The Senate Committee on Finance (Committee) has jurisdiction over the Medicare andMedicaid programs, and, accordingly, a responsibility to the more than 80 million Americanswho receive health care coverage, including organ transplants, under those programs. Thiscoverage includes payments for liver transplants at transplant centers overseen by the OrganProcurement and Transplantation Network (OPTN), which is operated by the United Network forOrgan Sharing (UNOS) under contract with the Health Resources and Services Administration(HRSA).
I was concerned to read recently about the alleged violations of organ transplant rules atthe St. Vincent Medical Center in Los Angeles California which allegedly resulted in a foreignnational, who was 52nd on the list of eligible recipients, receiving a liver transplant before othereligible patients on the list. I fully support efforts to encourage organ donation, but I believe suchefforts are easily undermined by events such as those alleged to have taken place at St. Vincent.As UNOS’s president, Francis L. Delmonico, stated in a recent press release, “The nationaltransplant system is dependent upon the public’s trust in the equity of that system.”
According to the Los Angeles Times, St. Vincent was notified on September 8, 2003 thata liver was available to transplant into a St. Vincent patient who was first on the regionaltransplant waiting list. That patient was home in Saudi Arabia on the advice of the then directorof St. Vincent’s liver transplant program. St. Vincent bypassed the second candidate on thewaiting list, who was located at another hospital, and nine of its own patients beforetransplanting the organ into another Saudi national who was 52nd on the list and whose costs werepaid for by the Royal Embassy of Saudi Arabia. Hospital staff subsequently altered records tomake it look like the donor liver had been transplanted into the first patient, who died within theyear, on the waiting list and that the liver removed from the actual transplant recipient had comefrom the first patient on the waiting list. St. Vincent first discovered problems with the transplantonly last month after conducting an internal investigation prompted by a routine UNOS audit.
I am glad that the problems at St. Vincent have been brought to light, but it should nothave taken two years to discover that there was a problem, especially when about 8 percent ofliver transplants at St. Vincent were to foreign nationals. That is significantly higher than the 1percent of organ transplants that go to foreign nationals nationwide, and higher than the 5 percentguideline established by the OPTN. I wonder how many Saudi nationals received livertransplants at St. Vincent while Americans awaiting a liver died.
Let me be clear, I am not against foreign nationals receiving organ transplants in thiscountry, but I want to be sure they do not receive priority over United States Citizens andPermanent Residents. I am also sorry that the patient designated to receive the organ in question,also a Saudi resident, died and I would like to be sure such a tragedy does not occur again.Accordingly, I am requesting that you provide me with the following information:
1. A copy of the two most recent OPTN contracts with UNOS, including the recentlyawarded contract.
2. A copy of the standards a transplant center must meet to remain in good standing, and, ifseparate, a list of violations that will cause a transplant center to lose good standing.
3. A list of all transplant centers, since 1986, that have been placed on bad standing or beenwarned that they may lose their good standing and the violations that resulted in the lossof good standing or warning.
4. A list of any allegations received by HRSA or UNOS in the past five years involving thepossible provision of an organ to a patient “out of line” or otherwise inequitabledistribution of organs and a brief description of how HRSA and/or UNOS investigatedand resolved each allegation.
5. A copy of the UNOS audit of St. Vincent.
6. A list of those actions HRSA and/or UNOS identify as a result of the audit of St. Vincentand any corresponding investigation into the alleged violation of transplant rules at St.Vincent.
7. A plan and detailed timetable for implementing actions listed in response to number 6.
I also intend to request that the Department of Health and Human Service, Office of Inspector General and the Department of Justice to conduct an investigation into the alleged violations oftransplant rules and possible violation of 42 U.S.C. 274e, which prohibits any purchase or sale ofhuman organs that affects interstate commerce.
Thank you in advance for having your staff coordinate with my staff about this letter byOctober 28, 2005. At that time I would like you to provide an estimated response date for items 5 through 7. Responses to questions 1 through 4 should be provided no later than November 4, 2005.
Sincerely,
Charles E. Grassley
Chairman
cc: Walter K. Graham
United Network for Organ Sharing
Inspector General Daniel R. Levinson
Department of Health and Human Services
Attorney General Alberto R. Gonzales
Department of Justice
Chairman Grassley follows up on violation of rules governing organ transplants, asks questions of federal watchdogs
WASHINGTON — Sen. Chuck Grassley is asking federal officials about the reasons behind a large organ transplant center suspending its liver program.
He based his inquiry on the September announcement by the St. Vincent Medical Centerin Los Angeles that a patient who was low on the waiting list for a liver transplant was bumpedahead to receive an organ intended for someone else.
While this type of situation is uncommon, Grassley said he’s concerned that two yearswent by before an audit discovered what had happened. Transplant centers are overseen by theOrgan Procurement and Transplantation Network, which is operated by the United Network forOrgan Sharing under contract with the Health Resources and Services Administration within theU.S. Department of Health and Human Services.
The text of Grassley’s letter to the Health Resources and Services Administration followsthis news release. Grassley is chairman of the Senate Committee on Finance, which haslegislative and oversight jurisdiction over the Medicare and Medicaid programs.
October 18, 2005
Elizabeth M. Duke, Ph.D
Health Resources and Services Administration
Parklawn Building
5600 Fishers Lane
Rockville, MD 20857
Dear Administrator Duke:
The Senate Committee on Finance (Committee) has jurisdiction over the Medicare andMedicaid programs, and, accordingly, a responsibility to the more than 80 million Americanswho receive health care coverage, including organ transplants, under those programs. Thiscoverage includes payments for liver transplants at transplant centers overseen by the OrganProcurement and Transplantation Network (OPTN), which is operated by the United Network forOrgan Sharing (UNOS) under contract with the Health Resources and Services Administration(HRSA).
I was concerned to read recently about the alleged violations of organ transplant rules atthe St. Vincent Medical Center in Los Angeles California which allegedly resulted in a foreignnational, who was 52nd on the list of eligible recipients, receiving a liver transplant before othereligible patients on the list. I fully support efforts to encourage organ donation, but I believe suchefforts are easily undermined by events such as those alleged to have taken place at St. Vincent.As UNOS’s president, Francis L. Delmonico, stated in a recent press release, “The nationaltransplant system is dependent upon the public’s trust in the equity of that system.”
According to the Los Angeles Times, St. Vincent was notified on September 8, 2003 thata liver was available to transplant into a St. Vincent patient who was first on the regionaltransplant waiting list. That patient was home in Saudi Arabia on the advice of the then directorof St. Vincent’s liver transplant program. St. Vincent bypassed the second candidate on thewaiting list, who was located at another hospital, and nine of its own patients beforetransplanting the organ into another Saudi national who was 52nd on the list and whose costs werepaid for by the Royal Embassy of Saudi Arabia. Hospital staff subsequently altered records tomake it look like the donor liver had been transplanted into the first patient, who died within theyear, on the waiting list and that the liver removed from the actual transplant recipient had comefrom the first patient on the waiting list. St. Vincent first discovered problems with the transplantonly last month after conducting an internal investigation prompted by a routine UNOS audit.
I am glad that the problems at St. Vincent have been brought to light, but it should nothave taken two years to discover that there was a problem, especially when about 8 percent ofliver transplants at St. Vincent were to foreign nationals. That is significantly higher than the 1percent of organ transplants that go to foreign nationals nationwide, and higher than the 5 percentguideline established by the OPTN. I wonder how many Saudi nationals received livertransplants at St. Vincent while Americans awaiting a liver died.
Let me be clear, I am not against foreign nationals receiving organ transplants in thiscountry, but I want to be sure they do not receive priority over United States Citizens andPermanent Residents. I am also sorry that the patient designated to receive the organ in question,also a Saudi resident, died and I would like to be sure such a tragedy does not occur again.Accordingly, I am requesting that you provide me with the following information:
1. A copy of the two most recent OPTN contracts with UNOS, including the recentlyawarded contract.
2. A copy of the standards a transplant center must meet to remain in good standing, and, ifseparate, a list of violations that will cause a transplant center to lose good standing.
3. A list of all transplant centers, since 1986, that have been placed on bad standing or beenwarned that they may lose their good standing and the violations that resulted in the lossof good standing or warning.
4. A list of any allegations received by HRSA or UNOS in the past five years involving thepossible provision of an organ to a patient “out of line” or otherwise inequitabledistribution of organs and a brief description of how HRSA and/or UNOS investigatedand resolved each allegation.
5. A copy of the UNOS audit of St. Vincent.
6. A list of those actions HRSA and/or UNOS identify as a result of the audit of St. Vincentand any corresponding investigation into the alleged violation of transplant rules at St.Vincent.
7. A plan and detailed timetable for implementing actions listed in response to number 6.
I also intend to request that the Department of Health and Human Service, Office of Inspector General and the Department of Justice to conduct an investigation into the alleged violations oftransplant rules and possible violation of 42 U.S.C. 274e, which prohibits any purchase or sale ofhuman organs that affects interstate commerce.
Thank you in advance for having your staff coordinate with my staff about this letter byOctober 28, 2005. At that time I would like you to provide an estimated response date for items 5 through 7. Responses to questions 1 through 4 should be provided no later than November 4, 2005.
Sincerely,
Charles E. Grassley
Chairman
cc: Walter K. Graham
United Network for Organ Sharing
Inspector General Daniel R. Levinson
Department of Health and Human Services
Attorney General Alberto R. Gonzales
Department of Justice
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