Organ Transplant Programs
Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain Gao ID: GAO-08-412 April 29, 2008Media reports in 2005 and 2006 highlighted serious problems at organ transplant programs, calling attention to possible deficits in federal oversight. Two agencies in the Department of Health and Human Services (HHS) oversee organ transplant programs: the Centers for Medicare & Medicaid Services (CMS) oversees transplant programs that receive Medicare reimbursement, and the Health Resources and Services Administration (HRSA) oversees the Organ Procurement and Transplantation Network (OPTN), which manages the nation's organ allocation system. GAO was asked to examine (1) federal oversight of transplant programs at the time the high-profile cases came to light in 2005 and 2006 and (2) changes that federal agencies have made or planned since then to strengthen oversight. GAO interviewed CMS, HRSA, and OPTN officials and reviewed agency documents and data and a CMS draft proposal for sharing information with HRSA.
Limitations in federal oversight of organ transplant programs existed when high-profile problems came to light in 2005 and 2006. These high-profile cases included, for example, a transplant program that lacked a full-time surgeon for over a year and had been turning down organs offered for patients at markedly high rates. At that time, CMS did not actively monitor heart, liver, lung, and intestine transplant programs, relying instead primarily on complaints to detect problems. CMS periodically monitored kidney transplant programs through on-site inspections, known as surveys, but the surveys reviewed compliance with requirements that had not been substantially updated in decades and were limited in scope. In addition, some programs were not actively monitored. At the same time, the OPTN actively monitored transplant programs for many types of potential problems and worked with the programs to resolve identified problems. The OPTN's monitoring activities, however, were not sufficient to promptly detect certain problems that prolonged the time that patients waited for transplants, such as inadequate staffing at transplant programs. CMS, HRSA, and the OPTN have made or plan to make changes to strengthen their oversight of organ transplant programs, but the effectiveness of these changes will depend, in part, on implementation and information sharing by CMS, HRSA, and the OPTN. In 2006, after high-profile problems came to light, CMS began actively monitoring heart, liver, lung, and intestine transplant programs. In a more fundamental change, CMS published new regulations in 2007 that establish a single set of updated requirements for all Medicare-approved transplant programs and provide for periodic reviews of programs. The OPTN has been working with HRSA to develop and implement a set of indicators to better detect problems that prolong the time patients wait for transplants. However, neither CMS nor the OPTN has fully implemented these changes, and their full effect remains to be seen. In particular, CMS has not determined the extent to which it will conduct on-site surveys in its periodic reviews of programs for Medicare reapproval. Under the new regulations, CMS may choose not to conduct on-site reapproval surveys of programs meeting certain Medicare requirements. Not conducting these surveys may limit CMS's ability to monitor for compliance with other Medicare requirements and to detect problems like some of those involved in the high-profile cases. As of January 2008, CMS had not determined how it will choose which transplant programs to survey, if any, among those for which it has discretion. Further, while CMS, HRSA, and the OPTN recognize the value of sharing information about potential problems at transplant programs, how they will share additional information from their oversight activities has not been resolved. A definitive agreement between CMS and HRSA on this issue will better ensure that problems at transplant programs are detected and corrected in a timely manner.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-08-412, Organ Transplant Programs: Federal Agencies Have Acted to Improve Oversight, but Implementation Issues Remain
This is the accessible text file for GAO report number GAO-08-412
entitled 'Organ Transplant Programs: Federal Agencies Have Acted to
Improve Oversight, but Implementation Issues Remain' which was released
on May 20, 2008.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as part
of a longer term project to improve GAO products' accessibility. Every
attempt has been made to maintain the structural and data integrity of
the original printed product. Accessibility features, such as text
descriptions of tables, consecutively numbered footnotes placed at the
end of the file, and the text of agency comment letters, are provided
but may not exactly duplicate the presentation or format of the printed
version. The portable document format (PDF) file is an exact electronic
replica of the printed version. We welcome your feedback. Please E-mail
your comments regarding the contents or accessibility features of this
document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Report to the Ranking Member, Committee on Finance, U.S. Senate:
United States Government Accountability Office:
GAO:
April 2008:
Organ Transplant Programs:
Federal Agencies Have Acted to Improve Oversight, but Implementation
Issues Remain:
GAO-08-412:
GAO Highlights:
Highlights of GAO-08-412, a report to the Ranking Member, Committee on
Finance, U.S. Senate.
Why GAO Did This Study:
Media reports in 2005 and 2006 highlighted serious problems at organ
transplant programs, calling attention to possible deficits in federal
oversight. Two agencies in the Department of Health and Human Services
(HHS) oversee organ transplant programs: the Centers for Medicare &
Medicaid Services (CMS) oversees transplant programs that receive
Medicare reimbursement, and the Health Resources and Services
Administration (HRSA) oversees the Organ Procurement and
Transplantation Network (OPTN), which manages the nation‘s organ
allocation system. GAO was asked to examine (1) federal oversight of
transplant programs at the time the high-profile cases came to light in
2005 and 2006 and (2) changes that federal agencies have made or
planned since then to strengthen oversight. GAO interviewed CMS, HRSA,
and OPTN officials and reviewed agency documents and data and a CMS
draft proposal for sharing information with HRSA.
What GAO Found:
Limitations in federal oversight of organ transplant programs existed
when high-profile problems came to light in 2005 and 2006. These high-
profile cases included, for example, a transplant program that lacked a
full-time surgeon for over a year and had been turning down organs
offered for patients at markedly high rates. At that time, CMS did not
actively monitor heart, liver, lung, and intestine transplant programs,
relying instead primarily on complaints to detect problems. CMS
periodically monitored kidney transplant programs through on-site
inspections, known as surveys, but the surveys reviewed compliance with
requirements that had not been substantially updated in decades and
were limited in scope. In addition, some programs were not actively
monitored. At the same time, the OPTN actively monitored transplant
programs for many types of potential problems and worked with the
programs to resolve identified problems. The OPTN‘s monitoring
activities, however, were not sufficient to promptly detect certain
problems that prolonged the time that patients waited for transplants,
such as inadequate staffing at transplant programs.
CMS, HRSA, and the OPTN have made or plan to make changes to strengthen
their oversight of organ transplant programs, but the effectiveness of
these changes will depend, in part, on implementation and information
sharing by CMS, HRSA, and the OPTN. In 2006, after high-profile
problems came to light, CMS began actively monitoring heart, liver,
lung, and intestine transplant programs. In a more fundamental change,
CMS published new regulations in 2007 that establish a single set of
updated requirements for all Medicare-approved transplant programs and
provide for periodic reviews of programs. The OPTN has been working
with HRSA to develop and implement a set of indicators to better detect
problems that prolong the time patients wait for transplants. However,
neither CMS nor the OPTN has fully implemented these changes, and their
full effect remains to be seen. In particular, CMS has not determined
the extent to which it will conduct on-site surveys in its periodic
reviews of programs for Medicare reapproval. Under the new regulations,
CMS may choose not to conduct on-site reapproval surveys of programs
meeting certain Medicare requirements. Not conducting these surveys may
limit CMS‘s ability to monitor for compliance with other Medicare
requirements and to detect problems like some of those involved in the
high-profile cases. As of January 2008, CMS had not determined how it
will choose which transplant programs to survey, if any, among those
for which it has discretion. Further, while CMS, HRSA, and the OPTN
recognize the value of sharing information about potential problems at
transplant programs, how they will share additional information from
their oversight activities has not been resolved. A definitive
agreement between CMS and HRSA on this issue will better ensure that
problems at transplant programs are detected and corrected in a timely
manner.
What GAO Recommends:
GAO recommends that the Secretary of Health and Human Services direct
(1) CMS to develop a methodology for conducting on-site surveys for
Medicare reapproval to ensure that at least some programs meeting
certain Medicare criteria are surveyed and (2) CMS and HRSA to
establish a time frame for finalizing an agreement to share information
from their oversight activities. HHS concurred with both
recommendations.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-412]. For more
information, contact Randall B. Williamson at (202) 512-7114 or
williamsonr@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Limitations Existed in Federal Oversight at the Time High-Profile
Problems Came to Light:
CMS, HRSA, and the OPTN Have Acted to Strengthen Oversight, but the
Full Effect of These Actions Will Depend on Implementation and Further
Information Sharing:
Conclusions:
Recommendations for Executive Action:
Agency Comments:
Appendix I: Medicare Conditions of Participation for Transplant
Centers:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Number of Organ Transplant Centers and Programs, 2008:
Table 2: Status of the 49 Extra-Renal Transplant Programs That Did Not
Meet NCD Volume Criteria in 2005, 2006, or Both:
Table 3: Medicare Requirements for Transplant Programs for Which the
OPTN Is Providing Data to CMS:
Table 4: Summary of Medicare Conditions of Participation for Transplant
Centers:
Figure:
Figure 1: Number of Organ Transplants Performed, Calendar Years 1997-
2007:
Abbreviations:
CMS: Centers for Medicare & Medicaid Services:
CoP: condition of participation:
ESRD: end-stage renal disease:
HHS: Department of Health and Human Services:
HMO: health maintenance organization:
HRSA: Health Resources and Services Administration:
MPSC: Membership and Professional Standards Committee:
NCD: national coverage determination:
OPTN: Organ Procurement and Transplantation Network:
UNOS: United Network for Organ Sharing:
[End of section]
United States Government Accountability Office: Washington, DC 20548:
April 29, 2008:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
Dear Senator Grassley:
Organ transplantation has become increasingly common, with over 28,000
organ transplants performed in the United States in 2007. Over 250 U.S.
hospitals have organ transplant centers. Many of these centers operate
multiple transplant programs that each specialize in the
transplantation of a specific organ, such as the kidneys, heart, liver,
lungs, intestines, or pancreas. Despite increases in organ donations,
the demand for organs continues to exceed the available
supply.[Footnote 1] Over 6,000 people die each year in the United
States while waiting for organ transplants. The scarcity of organs
relative to demand emphasizes the need to ensure both the equitable
allocation of organs and proper oversight of the organ transplantation
system, including the programs that perform organ transplants.
Two agencies within the Department of Health and Human Services (HHS)
are involved in overseeing the organ transplantation system. These two
agencies have responsibilities that differ in some respects but overlap
in others.
* HHS's Health Resources and Services Administration (HRSA) is
responsible for overseeing the Organ Procurement and Transplantation
Network (OPTN), a nonprofit network of transplant centers and others in
the transplant community that was established in 1984 to manage the
nation's organ allocation system. The OPTN's responsibilities include
maintaining a list of individuals waiting for transplants, operating a
computerized system for matching donated organs with individuals on the
waiting list, and developing policies for how organs are to be
allocated. The OPTN is administered by a nonprofit organization that
has a contract with HRSA.[Footnote 2] Historically, the OPTN's primary
focus has been ensuring the equitable allocation of donated organs, and
its policies include detailed allocation rules for matching donated
organs with individuals on the waiting list.[Footnote 3] Its policies
also address other areas related to transplantation, such as the
training and experience of key transplant personnel and performance
standards for transplant programs related to patient survival rates and
transplant activity. More recently the OPTN's activities expanded to
include monitoring members' compliance with federal regulations and
OPTN policies. The OPTN monitors its members' compliance through
various mechanisms, such as on-site reviews of transplant programs and
regular reviews of organ allocations, and is responsible for reporting
member noncompliance and any other issues affecting patient health or
public safety to HRSA.
* HHS's Centers for Medicare & Medicaid Services (CMS)[Footnote 4] is
responsible for regulating transplant programs that receive
reimbursement under the Medicare program.[Footnote 5] CMS oversees
fewer transplant programs than the OPTN because not all transplant
programs participate in Medicare.[Footnote 6] In addition, CMS's range
of requirements for Medicare-approved transplant programs differs from
the OPTN's; for example, CMS does not have specific requirements for
organ allocation procedures. At the same time, CMS's requirements
address some areas in common with the OPTN, such as minimum
qualifications for some transplant program personnel and patient
survival rates. CMS has monitored some transplant programs by
contracting with state agencies to conduct routine on-site inspections,
known as surveys.
In 2005 and 2006, media reports of problems at several organ transplant
programs drew attention to possible shortcomings in federal oversight,
noting that some problems were not detected or addressed by the OPTN or
CMS in a timely fashion. Three cases that occurred at different
facilities in California received particular attention because of the
seriousness of the problems involved. The OPTN's oversight brought one
of the cases to light, while individuals alerted federal agencies or
the media to the other cases.
* In 2003, a liver transplant program used one patient's high position
on the waiting list to obtain a liver for someone else who was lower on
the waiting list, bypassing more than 50 patients who had higher
priority for the liver than the actual recipient. Medical records were
falsified to conceal the switch, and the patient who had the highest
priority for the liver later died without a transplant. A routine OPTN
on-site review in 2005 led the transplant program's staff to review the
case and self-report the problem to the OPTN.
* At another facility, the liver transplant program did not have a full-
time transplant surgeon on staff even though it had led the OPTN and
patients to believe otherwise. From mid-2004 until the program closed
over a year later, the program lacked a full-time surgeon and had been
turning down organs offered for patients on the waiting list at rates
markedly higher than regional and national averages. A patient
complaint in 2005 led to a CMS investigation that first uncovered the
situation.
* In 2004, a health maintenance organization (HMO) notified over 1,500
of its enrollees waiting for kidney transplants that it would no longer
pay for their transplants unless they were performed at a new kidney
transplant program it was about to open. The new transplant program,
however, was unable to properly handle the large influx of patients and
did not provide contingency plans for patients to receive transplants
through other programs. As a result, patients' access to transplants
was impeded. A whistleblower contacted the media, and in May 2006,
media articles about the situation alerted the OPTN and CMS to the
problem.
Concerned that these recent issues at organ transplant programs could
indicate more systemic problems, you asked us to examine federal
oversight of the organ transplantation system. This report discusses
(1) federal oversight of transplant programs at the time the high-
profile cases came to light in 2005 and 2006 and (2) the changes that
federal agencies have made or planned since then to strengthen their
capacity to detect and resolve compliance problems at organ transplant
programs.[Footnote 7]
Our review encompassed the OPTN's and HRSA's activities to oversee
organ transplant programs and CMS's activities to oversee Medicare-
approved organ transplant programs.[Footnote 8] To examine the OPTN's,
HRSA's, and CMS's oversight activities, we reviewed relevant laws,
regulations, policies, and other documents and interviewed OPTN and
HRSA officials and officials from CMS's central office and from the 5
(of 10) regional offices responsible for overseeing the largest numbers
of transplant programs. We also reviewed case files from the OPTN
detailing the OPTN's review of and actions taken on compliance cases
that occurred from 2003 through 2006, including the three high-profile
cases;[Footnote 9] the OPTN's data on transplant programs that did not
meet OPTN performance standards for clinical outcomes or transplant
activity from January 2003 through October 2006; the OPTN contract with
HRSA; CMS data on surveys of renal (kidney) transplant programs; CMS
data on reviews of extra-renal (heart, liver, lung, and intestine)
transplant programs conducted in 2006 and 2007;[Footnote 10] CMS
complaint investigations of the three high-profile cases; and a CMS
draft proposal for sharing information with HRSA. We examined the
reliability of the data used in this report by performing appropriate
electronic data checks and checks for obvious errors, such as missing
data and data outside of expected ranges. We also interviewed officials
who were knowledgeable about the data. We determined that the data we
used were sufficiently reliable for our purposes. In addition, we
conducted interviews with experts from associations representing
transplant professionals about both CMS's and the OPTN's oversight of
transplant programs. We conducted this performance audit from August
2006 through April 2008 in accordance with generally accepted
government auditing standards. Those standards require that we plan and
perform the audit to obtain sufficient, appropriate evidence to provide
a reasonable basis for our findings and conclusions based on our audit
objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.
Results in Brief:
Limitations in federal oversight of organ transplant programs existed
at the time high-profile problems came to light in 2005 and 2006. The
nature of these limitations differed for CMS and the OPTN. CMS's
oversight activities for both extra-renal and renal transplant programs
were incomplete in several respects. For example, until 2006, CMS did
not actively monitor extra-renal transplant programs; instead, the
agency relied primarily on complaints to detect problems. CMS did
periodically monitor renal transplant programs through contracts with
state agencies to conduct on-site surveys and did act to resolve
identified problems, but the surveys reviewed compliance with
requirements that had not been substantially updated in decades and
were limited in scope. In addition, some programs were not actively
monitored. In contrast, the OPTN actively monitored for many types of
noncompliance and poor performance and acted to resolve identified
problems. The OPTN's monitoring activities, however, did not include
methods capable of promptly detecting certain problems that prolonged
the time that patients waited for transplants, such as insufficient
staffing at transplant programs. For example, until media reports
surfaced, the OPTN was not aware of such problems in two of the high-
profile cases. The OPTN also did not always meet its goals for
conducting on-site reviews, one component of its monitoring activities.
CMS, HRSA, and the OPTN have made or plan to make changes to strengthen
federal oversight of organ transplant programs, but the effectiveness
of the changes will depend in part on their implementation and the
degree of information sharing that the agencies agree to undertake. In
2006, after high-profile problems came to light, CMS began actively
monitoring extra-renal transplant programs. In a more fundamental
change, CMS published new Medicare regulations in 2007, establishing a
single set of expanded and updated requirements for both extra-renal
and renal transplant programs and procedures for periodic reviews of
Medicare-approved programs. For its part, the OPTN, with HRSA's
involvement, has taken steps to address previous shortcomings. For
example, the OPTN has been working with HRSA to develop and implement a
set of indicators to better detect problems that prolong the time
patients wait for transplants. The effects of CMS's and the OPTN's
changes remain to be seen, however, as not all changes have been fully
implemented. In particular, CMS has not determined the extent to which
it will include on-site surveys in its periodic reviews of transplant
programs for Medicare reapproval. Under the new regulations, CMS may
choose not to conduct on-site reapproval surveys of transplant programs
meeting certain Medicare requirements. Not conducting such surveys may
limit CMS's ability to monitor these programs for compliance with other
Medicare requirements and to detect problems like some of those
involved in the high-profile cases. As of January 2008, CMS had not
determined how it will choose which transplant programs to survey for
reapproval, if any, among those for which it has discretion. Further,
CMS and HRSA have not determined how they will share information about
potential problems at transplant programs. CMS developed a proposal
outlining how the agencies could share such information, but the
agencies have not yet finalized an agreement. Finalizing an agreement
delineating the scope and a time frame for sharing information from
their oversight of transplant programs is important to ensure that in
the future problems at transplant programs are detected and corrected
in a timely manner.
To increase opportunities for identifying potential problems at
transplant programs, we are recommending that the Secretary of Health
and Human Services direct the Administrator of CMS to develop a
methodology for conducting on-site surveys for Medicare reapproval to
ensure that at least some transplant programs meeting certain Medicare
requirements receive an on-site survey, and that the Secretary direct
the Administrators of CMS and HRSA to establish a time frame for
finalizing an agreement for CMS, HRSA, and the OPTN to share
information from their oversight activities.
In commenting on a draft of this report, HHS concurred with our
recommendations. HHS agreed that CMS should develop a methodology for
conducting on-site surveys for Medicare reapproval, noting that CMS has
developed an initial framework for doing so but that its implementation
will depend on resources. HHS also agreed with our recommendation that
HRSA and CMS establish a time frame for finalizing an agreement to
share information from their oversight activities. The comments noted
that CMS would like to finalize an agreement with HRSA by June 30,
2008, and that even in the absence of a formal agreement, CMS and HRSA
have shared information on several occasions.
Background:
Organ transplants are becoming increasingly common. The 28,352 organ
transplants performed in the United States in 2007 represent an
increase of about 40 percent since 1997. (See fig. 1.) Kidney
transplants are the most common procedure, accounting for almost 60
percent of transplants. Most transplanted organs come from deceased
donors, but a significant portion (22 percent in 2007) come from living
donors who may donate, for example, a kidney or a segment of liver or
lung.
Figure 1: Number of Organ Transplants Performed, Calendar Years 1997-
2007:
[See PDF for image]
This figure is a stacked vertical bar graph depicting the following
data:
Year of transplant: 1997;
Kidney transplants: 11,703;
Liver transplants: 4,188;
Heart transplants: 2,293;
Other transplants: 2,123
Year of transplant: 1998;
Kidney transplants: 12,452;
Liver transplants: 4,516;
Heart transplants: 2,348;
Other transplants: 2,202.
Year of transplant: 1999;
Kidney transplants: 12,760;
Liver transplants: 4,751;
Heart transplants: 2,188;
Other transplants: 2,317.
Year of transplant: 2000;
Kidney transplants: 13,613;
Liver transplants: 4,997;
Heart transplants: 2,199;
Other transplants: 2,442.
Year of transplant: 2001;
Kidney transplants: 14,266;
Liver transplants: 5,195;
Heart transplants: 2,202;
Other transplants: 2,561.
Year of transplant: 2002;
Kidney transplants: 14,779;
Liver transplants: 5,331;
Heart transplants: 2,155;
Other transplants: 2,642.
Year of transplant: 2003;
Kidney transplants: 15,137;
Liver transplants: 5,673;
Heart transplants: 2,057;
Other transplants: 2,604.
Year of transplant: 2004;
Kidney transplants: 16,004;
Liver transplants: 6,169;
Heart transplants: 2,015;
Other transplants: 2,847.
Year of transplant: 2005;
Kidney transplants: 16,481;
Liver transplants: 6,442;
Heart transplants: 2,125;
Other transplants: 3,063.
Year of transplant: 2006;
Kidney transplants: 17,091;
Liver transplants: 6,650;
Heart transplants: 2,193;
Other transplants: 2,999.
Year of transplant: 2007;
Kidney transplants: 16,622;
Liver transplants: 6,492;
Heart transplants: 2,210;
Other transplants: 3,028.
Notes: Data are as of February 29, 2008. Other includes lung, pancreas,
and intestine transplants as well as procedures involving the
transplantation of multiple organs, such as kidney-pancreas and heart-
lung transplants.
Source: The OPTN.
[End of figure]
As of January 2008, 254 U.S. hospitals had a transplant center;
collectively, these centers operated 844 individual transplant
programs. (See table 1.) Nearly all states had at least one transplant
center, but some types of transplant programs, such as lung or
intestine transplant programs, were located in a limited number of
states.
Table 1: Number of Organ Transplant Centers and Programs, 2008:
Total number of organ transplant centers: 254;
Number of organ transplant centers with: Kidney programs: 245;
Number of organ transplant centers with: Liver programs: 126;
Number of organ transplant centers with: Pancreas programs[A]: 175;
Number of organ transplant centers with: Heart programs: 132;
Number of organ transplant centers with: Lung programs: 66;
Number of organ transplant centers with: Heart-lung programs: 54;
Number of organ transplant centers with: Intestine programs: 46;
Total number of organ transplant programs: 844.
Source: The OPTN.
Notes: Data are as of January 23, 2008. Data on transplant centers that
perform heart-lung transplants are captured in a separate category.
Data on transplant centers that perform multi-organ transplants other
than heart-lung transplants are captured under both organs involved.
[A] Pancreas programs include programs performing transplants of
pancreas islet cells.
[End of table]
Organ Transplantation Process:
The organ transplantation process involves the following steps.
Step 1: The process begins when a patient's physician determines that
an organ transplant may be necessary and refers the patient to a
transplant program for evaluation.
Step 2: If the transplant program determines that the patient is a
candidate for transplantation, the individual is registered on the
national organ transplant waiting list maintained by the OPTN.
Step 3: When an organ becomes available, the local organ procurement
organization enters information about the donor organ into a national
computer system operated by the OPTN. The computer system generates a
ranked list of potential recipients based on how closely their medical
characteristics--such as blood type, organ size, and genetic makeup--
match the donor's, as well as on the urgency of their medical
conditions, their time spent on the waiting list, and their proximity
to the donor.[Footnote 11]
Step 4: Transplant programs whose patients appear on the list are
contacted. The decision whether to accept an organ rests with the
patient's transplant team. Because the length of time organs can viably
be kept outside the body is limited, the transplant team has 1 hour to
make its decision. If the organ is not accepted, it is offered to the
center with the next patient on the list until the organ is placed.
Step 5: Once the organ is accepted for a potential recipient, a
surgical team comes to the donor hospital to recover the organ. The
recovered organ is transported from the donor to the recipient hospital
for transplantation into the patient.
The OPTN's Role and Responsibilities:
The OPTN was created pursuant to the National Organ Transplant Act,
which called for HHS to provide by contract for the establishment and
operation of the OPTN to manage the nation's organ allocation
system.[Footnote 12] Prior to that time, national policies regarding
transplantation did not exist and organ allocation was carried out on
an ad hoc basis. The OPTN's functions include maintaining a list of
patients waiting for transplants, operating a system for matching
donated organs with individuals on the list, establishing medical
criteria for allocating organs, collecting and analyzing data on organs
donated and transplanted, and conducting work to increase the supply of
donated organs. The OPTN's members include all transplant centers and
organ procurement organizations in the country; tissue-typing
laboratories;[Footnote 13] professional scientific and medical
organizations; and other organizations and individuals interested in
organ donation or transplantation, such as organ donors, recipients,
and their families. The OPTN's Membership and Professional Standards
Committee (MPSC) is responsible for overseeing the compliance of OPTN
members with applicable federal regulations and OPTN policies. The OPTN
collects most of the funding to cover its operating costs (estimated to
be about $25 million in 2006) from candidate registration fees paid by
OPTN members; HRSA's funding for the OPTN is capped at $2 million a
year.[Footnote 14]
From early in its history, the OPTN has been responsible for operating
an equitable nationwide system of organ allocation. The OPTN develops
detailed policies that govern the distribution of organs and other
issues related to transplantation, such as the specific credentials
required of transplant surgeons and physicians. HHS clarified the
OPTN's oversight responsibilities in regulations implemented in 2000.
[Footnote 15] The regulations require the OPTN to design plans and
procedures for conducting ongoing and periodic reviews of all member
transplant centers for compliance with the regulations and OPTN
policies. The regulations also require the OPTN to advise the Secretary
of Health and Human Services when the results of its reviews indicate
noncompliance with the regulations or OPTN policies or otherwise
indicate a risk to patient health or public safety.
While the OPTN is required to monitor transplant programs' compliance
with its policies, OPTN policies are considered voluntary or
advisory.[Footnote 16] To promote transplant programs' voluntary
compliance with OPTN policies, the OPTN employs a confidential review
process in which OPTN members evaluate the medical care provided by
colleagues to determine compliance with OPTN policies and regulations.
[Footnote 17] The OPTN emphasizes that its confidential review process
focuses on corrective action rather than punishment and is aimed at
continuous quality and performance improvement. On its own, the OPTN
can impose certain sanctions against noncompliant transplant programs,
such as issuing a letter of warning or placing a program on probation.
The OPTN can also request that the Secretary of Health and Human
Services impose stronger enforcement actions, including terminating a
program's ability to receive organs or reimbursement under Medicare.
HRSA's Oversight of the OPTN:
The OPTN contract with HRSA includes several requirements related to
the oversight of transplant programs. For example, the contract
requires the OPTN to conduct on-site reviews of heart, liver, and lung
transplant programs at least once every 3 years and to perform ongoing
analyses of organ allocations.[Footnote 18] The OPTN is also required
to submit monthly reports to HRSA describing transplant program-
specific instances of noncompliance with OPTN policies and the status
of corrective action plans. To ensure that the OPTN is fulfilling its
responsibilities to monitor transplant programs' compliance, HRSA
officials participate as ex officio nonvoting members on the OPTN's
Board of Directors and committees, including the MPSC. According to
HRSA officials, the agency's presence on OPTN committees helps ensure
that the committees' recommendations are consistent with federal laws
and regulations. In addition, HRSA officials said that they and OPTN
officials communicate regularly about all aspects of the OPTN's
performance, including monitoring transplant program compliance.
CMS's Role and Responsibilities:
CMS is responsible for overseeing organ transplant programs that
receive Medicare reimbursement for transplant services. At the time the
high-profile cases came to light, CMS had different criteria and
procedures for overseeing extra-renal and renal transplant programs
participating in Medicare.
* Extra-renal transplant programs participated in Medicare by meeting
the criteria set forth in various national coverage determinations
(NCD) published beginning in 1987.[Footnote 19] The NCDs provide that
transplants of extra-renal organs for Medicare beneficiaries will be
considered reasonable and necessary and therefore reimbursable under
Medicare if they are performed in a facility that CMS approves as
meeting specified criteria. For example, heart, liver, and lung
transplant programs were required to have written patient selection
criteria, perform a minimum number of transplants each year, and meet
minimum patient survival rates. The NCDs for these programs did not
include criteria for reevaluating the ongoing performance of Medicare-
approved programs.
* Renal transplant programs participated in Medicare by meeting
regulatory standards for facilities furnishing end-stage renal disease
(ESRD) services.[Footnote 20] ESRD facilities include those providing
dialysis services and renal transplant services.[Footnote 21] CMS
monitored renal transplant programs' compliance with Medicare
requirements by contracting with state survey agencies--generally state
departments of health--to conduct routine on-site inspections known as
surveys.[Footnote 22] If a survey found a facility to be out of
compliance and if it had a major deficiency that went uncorrected, then
the facility was subject to termination from the Medicare program.
In 2005, recognizing the need to update existing requirements for extra-
renal and renal transplant programs and that the NCDs did not include
criteria for reassessing the performance of extra-renal transplant
programs, CMS promulgated proposed regulations to establish a single
set of Medicare requirements for both renal and extra-renal transplant
programs.[Footnote 23]
Limitations Existed in Federal Oversight at the Time High-Profile
Problems Came to Light:
CMS's and, to a lesser extent, the OPTN's oversight of transplant
programs was not comprehensive at the time high-profile problems came
to light in 2005 and 2006. CMS did not actively monitor extra-renal
transplant programs' compliance with criteria for Medicare approval.
CMS monitored renal transplant programs through contracts with state
agencies, but the surveys reviewed compliance with requirements that
had not been substantially updated in decades and were limited in
scope; also, not all programs were actively monitored. At the same
time, the OPTN actively monitored transplant programs and took action
to resolve identified problems, but its oversight activities fell short
in some respects--the OPTN's monitoring did not include methods capable
of promptly detecting problems at transplant programs that prolonged
the time that patients waited for transplants, and the OPTN did not
always meet its goals for conducting on-site reviews.
CMS's Oversight Was Limited and Inconsistent:
CMS's oversight varied between extra-renal and renal transplant
programs and was not comprehensive even for renal transplant programs,
which received more oversight.
CMS Did Not Actively Monitor Extra-Renal Transplant Programs:
At the time high-profile problems came to light in 2005 and 2006, CMS
was not actively monitoring the ongoing compliance of Medicare-approved
extra-renal transplant programs with the criteria specified in the
NCDs, which included performing a minimum number of transplants per
year and achieving a minimum patient survival rate.[Footnote 24]
Instead, CMS's procedure was to conduct only an initial review of an
extra-renal program to determine if it met the criteria in the NCDs at
the time the program applied for Medicare approval. Once an extra-renal
transplant program received Medicare approval, CMS generally did not
assess the program's continued compliance with NCD criteria.[Footnote
25] Although the NCDs for heart and liver transplant programs called
for programs to submit an application for Medicare reapproval every 3
years, the NCDs did not specify and CMS did not otherwise establish a
process for doing so, and programs continued to retain Medicare
approval without reapplying.
To oversee extra-renal transplant programs' ongoing compliance with
criteria for Medicare approval, CMS relied on programs to self-report
significant changes and complaints from Medicare beneficiaries and
others that would alert CMS to a potential problem. CMS officials or
state surveyors conducted complaint investigations after receiving
complaints against transplant programs or otherwise becoming aware of
potential problems, such as through media reports. CMS officials in
three of the five regions we contacted reported that they or state
surveyors had investigated nine complaints against extra-renal
transplant programs during the period of 2000 through 2006.[Footnote
26] For example, one of the three high-profile cases initially came to
light after CMS received a patient complaint about a liver transplant
program. CMS officials investigated the complaint and discovered that
this transplant program had not had a full-time surgeon on staff in
over a year. After completing the complaint investigation, CMS withdrew
Medicare approval from the transplant program, which closed shortly
thereafter.
CMS Had a Process in Place to Monitor Renal Transplant Programs, but
Some Programs Still Were Not Actively Reviewed:
CMS's oversight of renal transplant programs was more active than its
oversight of extra-renal transplant programs, although it also had
limitations. CMS contracted with state agencies to periodically perform
on-site surveys of renal transplant programs for compliance with
Medicare requirements and had a process in place to resolve problems
identified during these surveys. When state surveyors identified
compliance problems with requirements during their reviews of renal
transplant programs, CMS generally acted to resolve these problems by
requiring programs to submit corrective action plans for coming back
into compliance with requirements. According to CMS data, major
problems were generally corrected within 90 days, and only one of the
five CMS regional offices we contacted reported that CMS had withdrawn
Medicare approval from a renal transplant program in its region since
2000 for failure to comply with Medicare requirements. This instance
was the high-profile case involving an HMO that was unable to properly
handle a large influx of patients to its program.
Although CMS had a process in place to periodically review renal
transplant programs through state agency surveys of ESRD facilities,
the surveys reviewed compliance with requirements that had not been
substantially updated in decades and were limited in scope. Medicare
regulations for ESRD facilities, including renal transplant programs,
were initially published in 1976 and, according to CMS officials, had
not been substantially updated since then.[Footnote 27] For example,
the regulations did not include a requirement that renal transplant
programs achieve a minimum patient survival rate. Experts in the
transplantation field have since recognized the importance of patient-
centered, outcome-oriented performance measures, such as survival
rates, and recommended their use.[Footnote 28] In addition, while the
Medicare requirements specified that renal transplant programs should
perform a minimum number of transplants per year, CMS instructions to
state surveyors did not call for them to verify that these numbers were
achieved.[Footnote 29]
Furthermore, CMS's process to review renal transplant programs did not
ensure that all of these programs were actively monitored in practice.
Our analysis of CMS data as of May 2007 showed that 31, or about 1 in
8, active, Medicare-approved renal transplant programs had been
mistakenly classified as no longer participating in Medicare in CMS's
survey database or had been mistakenly excluded from the
database.[Footnote 30] According to CMS officials, these programs would
not have been surveyed again after these mistakes occurred. Our
analysis showed that as of May 2007 the length of time since the 31
programs had last been surveyed ranged from about 4 to over 20 years;
over three-quarters of these programs had not been surveyed in the
previous 10 years. By comparison, most correctly classified programs
had been surveyed in the previous 4 years, although 34 programs had
not, and 9 of those programs had not been surveyed in the previous 10
years. CMS did not have survey frequency goals specific to renal
transplant programs. However, CMS has acknowledged that not all state
agencies achieved CMS goals for conducting surveys of all ESRD
facilities (of which renal transplant programs are a subset).[Footnote
31] CMS officials emphasized that the CMS survey and certification
budget had not been fully funded during fiscal years 2005 through 2007.
The OPTN's Oversight Was Active and Multipronged but Was Not Sufficient
to Detect All Problems:
The OPTN's oversight, while more active and extensive than CMS's
oversight, also had limitations; most notably, its monitoring methods
were insufficient to promptly detect problems affecting patients
waiting for transplants.
The OPTN Actively Monitored for Many Types of Problems:
The OPTN monitored transplant programs on an ongoing basis for numerous
types of potential problems. The OPTN's oversight was conducted by both
OPTN staff and by its MPSC, which includes OPTN members who are medical
professionals from the field of transplantation. The OPTN's numerous
activities to monitor compliance with OPTN policies included reviewing
information on patients placed on transplant waiting lists, allocations
of organs from deceased donors, physician credentials, and timely
submission of required data. These reviews were generally scheduled to
occur weekly or quarterly. The OPTN also monitored on a quarterly basis
two key indicators of potential performance problems at transplant
programs--lower-than-expected patient and organ survival rates and
failure to perform any transplants during a specified period of time.
In addition, the OPTN conducted periodic routine on-site reviews of
heart and liver transplant programs to review patient medical records;
the OPTN's goal was to conduct these on-site reviews once every 3
years.[Footnote 32]
The OPTN's monitoring activities identified many problems, ranging from
minor anomalies with organ allocations to more significant problems,
including one of the three high-profile cases. The case came to light
after a routine OPTN on-site review led staff at the transplant program
to self-report that a recipient of a liver transplant had
inappropriately received the transplant ahead of others on the waiting
list and that the program had falsified patient medical records in
order to conceal its actions.[Footnote 33] Our review of a sample of
compliance cases showed that the OPTN most often identified members'
noncompliance with OPTN policies through its routine on-site reviews
(15 of 43 cases).
Our review of OPTN compliance cases and performance data and
discussions with OPTN officials indicated that the OPTN took steps to
resolve compliance and performance problems it identified during its
monitoring activities. As explained below, the OPTN's process for
resolving members' noncompliance with OPTN policies differs from its
process for resolving members' performance problems, such as lower-
than-expected survival rates.
* Noncompliance with OPTN policies. OPTN officials emphasize that the
OPTN works to resolve most cases of noncompliance without resorting to
strong enforcement actions. Our review of a sample of compliance cases
showed that the length of time for cases to be fully resolved varied
and depended on the nature of the case. For example, a relatively minor
case involving an organ allocation discrepancy was resolved within 4
months, while a case involving problems with medical record
documentation took about 3 years to resolve. The three high-profile
cases are examples of cases in which the OPTN took strong enforcement
actions. After the individual transplant programs involved in these
cases had announced that they would voluntarily close, the OPTN
continued to review the cases and eventually declared two of the
transplant centers that operated these transplant programs "Members Not
in Good Standing" and imposed a lesser sanction of probation on the
third transplant center.
* Performance problems. The OPTN flags for the MPSC's review transplant
programs that are not achieving OPTN performance standards for survival
rates or transplant activity, but these programs are not considered to
be out of compliance with OPTN policies. Instead, the OPTN works with
these programs until they meet the standards, sometimes sending peer
review teams on-site to consult with the programs, or until problems
are otherwise resolved (for example, if a program closes voluntarily).
OPTN officials said that programs with low survival rates typically
need to show improvement in outcomes before being released from review
by the MPSC and emphasized that this can take some time. Of 72 cases
the OPTN flagged for low survival rates in 2005, about 40 percent
remained under review by the MPSC as of August 2007.
The OPTN's Monitoring Did Not Detect All High-Profile Cases and Was Not
Always Timely:
Although the OPTN conducted numerous types of monitoring activities,
these activities did not incorporate methods capable of promptly
detecting problems at transplant programs that prolonged the time that
patients waited for transplants. For example, the OPTN regularly
flagged programs for review that did not perform any transplants in a
specified period of time.[Footnote 34] While helpful in detecting
completely inactive programs, this particular method did not identify
more subtle problems, such as a transplant program that was
understaffed and was turning down organs offered for patients at
markedly high rates. At the two transplant programs with high-profile
problems affecting patient access to transplants, enough transplants
were conducted that the programs were not flagged as inactive programs.
In addition, the transplants that did occur were successful enough that
the programs were not flagged as experiencing performance problems at
the time the problems came to light.[Footnote 35] However, far fewer
transplants were conducted than would be expected given the numbers of
patients on the waiting list, reflecting problems with understaffing
that ultimately affected patients' access to transplants at these
programs.
Even though a targeted method for detecting these problems was not in
place, separate pieces of information, if pieced together, could have
alerted the OPTN to at least one of the high-profile incidents. The
OPTN, however, missed opportunities to link these separate sources of
information. For example, OPTN staff who handle patient transfers were
aware that an HMO was attempting to transfer hundreds of patients to
its new transplant program at an unprecedented rate and was
experiencing problems with the transfers. However, they did not alert
other appropriate OPTN staff to the possible need for a compliance
review or to look into the situation by, for example, reviewing
available data that indicated far lower-than-expected numbers of
transplants at the new program. The problem eventually came to light
after a whistleblower alerted the news media.
In addition to having insufficient methods to detect some of the high-
profile cases, the OPTN was not always timely in conducting those
monitoring activities that it performs on-site, namely routine on-site
reviews and peer review site visits. Although the OPTN's goal was to
conduct routine on-site reviews of heart and liver programs once every
3 years, it had fallen behind this schedule. In December 2006, 50
percent of continuously active heart and liver transplant programs had
not been reviewed on-site in the previous 3 years and 38 percent had
not been reviewed on-site in the previous 4 years. OPTN and HRSA
officials attribute the delay in routine on-site reviews to HRSA's
directive to the OPTN to study a new lung allocation policy.
Additionally, in our review of performance data we observed that in
some cases peer review site visits were not conducted on a timely
basis. For about three-fourths of transplant programs (17 of 22) for
which the MPSC recommended a peer review site visit from July 2005
through July 2006, the site visit had not yet occurred a year after
being recommended. According to OPTN officials, a contributing factor
in the delay was that the number of programs recommended to receive a
peer review site visit significantly increased during 2005, resulting
in a backlog.[Footnote 36]
CMS, HRSA, and the OPTN Have Acted to Strengthen Oversight, but the
Full Effect of These Actions Will Depend on Implementation and Further
Information Sharing:
Since the high-profile cases came to light, CMS, HRSA, and the OPTN
have made some changes and planned others to improve federal oversight
of organ transplant programs; however, the full effect of these changes
remains to be seen. CMS has begun monitoring extra-renal transplant
programs and has finalized regulations that expand and unify Medicare
requirements for all types of transplant programs and establish
procedures for periodic review of transplant programs. The OPTN and
HRSA are working to develop and implement a set of indicators to help
the OPTN better identify problems that prolong the time patients wait
for transplants. Implementation of CMS's new requirements is in its
early stages, however, and CMS has not resolved the extent to which on-
site surveys will be performed as part of its periodic reviews of
programs for Medicare reapproval. Also, the OPTN's and HRSA's set of
indicators has not yet been implemented. Further, while CMS, HRSA, and
the OPTN have begun sharing basic transplant program data, how they
will share additional information resulting from their oversight
activities has not been resolved.
CMS Strengthened Oversight by Expanding Monitoring Efforts and Issuing
New Regulations:
CMS has made substantial changes to its oversight: the agency began
monitoring extra-renal transplant programs and, most significantly,
finalized new regulations that apply to all types of transplant
programs and that require on-site surveys of all transplant programs
applying for Medicare approval.
CMS Began Monitoring Extra-Renal Transplant Programs and Took Steps to
Withdraw Medicare Approval from the Most Problematic Programs:
After high-profile problems came to light, CMS began monitoring extra-
renal transplant programs' compliance with existing Medicare NCD
criteria in 2006. According to CMS officials, the agency's initial
monitoring effort revealed that nearly all 242 Medicare-approved
programs were complying with NCD criteria for meeting minimum survival
rates. A number of programs, however, were not in compliance with the
NCD annual transplant volume criteria, which specify that programs must
conduct a minimum number of transplants each year. CMS continued to
monitor extra-renal transplant programs and ultimately found that a
total of 49 extra-renal transplant programs did not meet the NCD
transplant volume criteria in 2005, 2006, or both. As a result, CMS
notified 11 programs that agency officials viewed as the most
problematic that they could lose Medicare approval for failure to
comply with NCD criteria.[Footnote 37] Ultimately, CMS withdrew
Medicare approval from 1 of the 11 programs; of the remaining 10
programs, 2 withdrew voluntarily and 8 programs were implementing
corrective action plans as of December 2007. (See table 2.)
Table 2: Status of the 49 Extra-Renal Transplant Programs That Did Not
Meet NCD Volume Criteria in 2005, 2006, or Both:
Noncompliant programs were notified by CMS that they could lose
Medicare approval for failure to comply with NCD criteria: 11:
* Programs voluntarily withdrew from Medicare: 2;
* Programs submitted corrective action plans that were approved by CMS:
8;
* Program submitted a corrective action plan that CMS rejected
(Medicare approval was withdrawn): 1.
Noncompliant programs were notified by CMS that they could lose
Medicare approval for failure to comply with NCD criteria: Noncompliant
programs were not notified by CMS: 38:
* Programs voluntarily withdrew from Medicare: 5;
* Programs improved and met transplant volume criteria in 2006: 12;
* Programs met or were projected to meet transplant volume criteria in
2007: 11;
* Programs were projected to remain out of compliance with volume
criteria in 2007: 10.
Source: GAO analysis of information provided by CMS.
[End of table]
CMS Established New Requirements That Apply to All Types of Transplant
Programs:
In March 2007, CMS made a more fundamental change to its oversight by
publishing final regulations establishing a new set of Medicare
requirements specifically for organ transplant programs. The
regulations include 13 core requirements known as Medicare conditions
of participation (CoP). Whereas renal and extra-renal transplant
programs were previously subject to different requirements and
regulatory procedures, the new regulations provide a single set of CoPs
and review procedures for all types of transplant programs. In
addition, the new regulations both update and expand upon previous
requirements. For example, the new CoPs incorporate an updated method
for calculating survival rates that reflects current best practices.
The CoPs also include entirely new requirements, such as those related
to the protection of living donors. (See app. I for more information
about the 13 CoPs.)
The new regulations also bring CMS requirements into substantial
alignment with OPTN policies. Specifically, 10 of the 13 CoPs pertain
to areas addressed in OPTN policies. In some instances, CMS
incorporated OPTN policies into its requirements such that these
policies are now enforceable under federal regulation for Medicare-
approved transplant programs. In some areas, the new regulations impose
additional requirements not covered by the OPTN. For example, while
OPTN policies require transplant programs to provide social support
services, CMS's regulations further require that social support
services be furnished by a qualified social worker, as defined by CMS.
In other areas, the new CMS requirements cover matters not addressed in
existing OPTN policies. For example, one CoP requires programs to
implement formal quality assessment and performance improvement
programs--a requirement not paralleled in OPTN policies. There are also
areas of OPTN policies, largely pertaining to organ allocation, which
the CMS regulations do not address.
New Regulations Also Established Procedures for Reviewing Transplant
Programs:
In addition to updating and expanding requirements and more closely
aligning them with OPTN policies, CMS's new regulations also subject
transplant programs to initial and periodic reviews for compliance with
the Medicare CoPs. Under the new regulations, all transplant programs
seeking Medicare approval are required to apply for initial approval;
programs that were previously Medicare approved must reapply.[Footnote
38] As part of determining compliance with the CoPs, each transplant
program that applies for Medicare approval will undergo an on-site
survey. Transplant programs that are in compliance with all CoPs will
be approved for participation in Medicare for 3 years. Prior to the end
of the initial 3-year approval period, CMS plans to reexamine data on
three key requirements, which together compose one of the
CoPs:[Footnote 39]
* Data submission: Transplant programs must submit OPTN-required data
to the OPTN within specified time frames.
* Clinical experience: Transplant programs must generally perform at
least 10 transplants over a 12-month period.
* Outcomes: Transplant programs must achieve expected survival rates.
[Footnote 40]
If a program is found to be in compliance with the three requirements
of this CoP, under the new regulations CMS may choose whether to
conduct an on-site reapproval survey of the program's compliance with
additional CoPs.
CMS plans to complete on-site surveys for transplant programs seeking
initial Medicare approval over the course of 3 years. CMS officials
reported that on-site surveys of transplant programs had begun as of
August 2007. The agency is prioritizing the order in which these
surveys will be conducted, so that programs that do not currently meet
the clinical experience and outcomes requirements will receive the
highest priority for surveys.[Footnote 41] According to CMS officials,
the agency plans to complete these high-priority surveys by the end of
fiscal year 2008; all initial surveys are planned to be completed by
the end of fiscal year 2010. Until a new Medicare approval decision is
made under the new regulations, currently approved extra-renal and
renal transplant programs will remain approved under the NCDs and
requirements for ESRD facilities, respectively.[Footnote 42]
The OPTN and HRSA Have Taken Steps to Address Shortcomings in Detection
of Problems:
To address shortcomings in the OPTN's ability to detect problems
affecting patients waiting for transplants, such as understaffing, the
OPTN and HRSA, along with another HRSA contractor, are working to
develop and implement a set of activity-level indicators. The set of
indicators would be used to monitor programs for problems, such as
understaffing, indicated by lower-than-expected activity levels in a
manner similar to how the OPTN currently monitors programs for
performance problems indicated by lower-than-expected survival rates.
The set of indicators includes two existing indicators already
developed by the OPTN, one of which, although available, was not
previously reviewed by the MPSC, and a new organ acceptance rate
indicator. The new indicator, which is intended to identify programs
exhibiting lower-than-expected rates of organ acceptance, is a key
component of the set of activity-level indicators and has been under
development since January 2006. According to the OPTN, the organ
acceptance rate indicator had been developed but not yet implemented
for kidney and liver transplant programs as of February 2008.
With HRSA's encouragement, the OPTN has also taken steps to increase
its capacity to conduct on-site monitoring activities and to improve
internal communication. The OPTN substantially increased its staff in
2007 in order to get back on schedule in conducting on-site reviews
once every 3 years. According to OPTN officials, the increase in staff
will also help the OPTN address its backlog of peer review site visits
and achieve its goal of conducting all peer review site visits within 3
months of the visit being recommended by the MPSC. To improve internal
communication, the OPTN reported that since 2006, its leadership has
emphasized the importance of shared communication, particularly across
departments. As a result, according to the OPTN, staff responsible for
managing the waiting list, including handling patient transfers, now
meet frequently with staff responsible for monitoring policy compliance
to share information about potential policy violations.
CMS, HRSA, and the OPTN Have Yet to Fully Implement Several Measures to
Improve Oversight:
Although CMS, HRSA, and the OPTN have taken steps to improve oversight
of transplant programs since the high-profile cases came to light,
three important areas remain in progress.
* One key unresolved question is the extent to which CMS will conduct
on-site reapproval surveys of transplant programs (as part of its new
review procedures) after transplant programs gain initial Medicare
approval under the new regulations. According to CMS's new regulations,
CMS may choose not to conduct on-site reapproval surveys for transplant
programs meeting data submission, clinical experience, and outcomes
requirements. This means that CMS could potentially choose not to
conduct any reapproval surveys for programs meeting these requirements.
While CMS officials said that they see value in conducting reapproval
surveys, just how CMS will apply its discretion remains unclear. As of
January 2008, CMS officials said that the agency had not decided how
many reapproval surveys it would conduct or how it would choose which
programs to survey among those that meet the aforementioned
requirements. They emphasized the agency's need to carefully consider
resource constraints in making these decisions. A decision by CMS not
to conduct an on-site reapproval survey at a transplant program means
that compliance with some CoPs would not be reviewed unless there was a
complaint investigation. As a result, problems at transplant programs
unrelated to the data submission, clinical experience, and outcomes
requirements--for example, a transplant program failing to provide
required protections for living donors or to sufficiently staff its
program--could go undetected. In two of the high-profile cases,
staffing problems that ultimately affected patients' access to
transplants would not have been detected by the outcomes indicator that
CMS has now adopted, and the numbers of transplants performed per year
at these programs exceeded or were close to CMS's clinical experience
requirement.
* Additional questions remain regarding the extent to which CMS will
accurately track on-site surveys to avoid the misclassification errors
we identified in our review and complete the surveys on a timely basis.
As a result of the new transplant regulations, renal transplant
programs will no longer share Medicare identification numbers with
dialysis facilities, and previously misclassified renal transplant
programs will at some point receive a new accurate classification in
CMS's survey database once they are approved. However, the potential
for transplant programs to be mistakenly classified may remain because
transplant programs within the same hospital will share one transplant
center Medicare identification number, according to CMS officials. CMS
officials said that they were highly aware of the need for their
systems to accurately track the status of each transplant program
separately. They said that they plan to test for this capability in
their new tracking system for transplant programs, which remains under
development. What also remains to be seen is the extent to which
surveys will occur on a timely basis. Prior to the new regulations,
state agencies did not always meet CMS goals for surveying ESRD
facilities. Now, under the new regulations, the responsibilities of
state agencies that will be conducting on-site surveys of transplant
programs will increase, since they will be required to survey both
renal and extra-renal transplant programs.[Footnote 43] With respect to
initial approval surveys, CMS's stated plan is that high-priority
surveys of transplant programs will be completed by the end of fiscal
year 2008, but as of January 2008, CMS officials expressed some
uncertainty about meeting this goal. Initial surveys of transplant
programs have been given a relatively high priority in the state agency
workload, but it is not definite that this high priority level will
continue because CMS has revised state agency workload priorities in
the past.[Footnote 44] Further, the priority level for reapproval
surveys is not yet known; a lower priority could affect how frequently
surveys occur.
* The last unresolved question concerns the OPTN's and HRSA's planned
organ acceptance rate indicator, which as part of a set of activity-
level indicators, could potentially improve the OPTN's ability to
detect transplant programs experiencing problems that prolong the time
patients wait for transplants. According to the OPTN, the organ
acceptance rate indicator for kidney and liver transplant programs has
been developed but, as of February 2008, has not yet been implemented;
HRSA officials expect the indicator to be in place within 1 year. HRSA
and OPTN officials reported that they are considering developing organ
acceptance rate indicators for transplant programs for other organ
types. Before extending the indicator to other types of programs,
however, the OPTN will first assess the effectiveness of the indicator
at detecting potential problems at kidney and liver transplant
programs, which perform larger volumes of transplants, and determine
the feasibility of developing an indicator for programs with lower
transplant volumes, such as heart and lung transplant programs.
CMS, HRSA, and the OPTN Are Sharing Basic Data on Transplant Programs,
but How They Will Share Additional Information from Their Oversight
Activities Has Not Been Resolved:
CMS, HRSA, and the OPTN have recognized the importance of sharing data
on transplant programs with one another and have taken initial steps to
share basic data. To help CMS assess programs' compliance with its new
Medicare requirements, the OPTN (through HRSA) is now sending CMS
certain basic transplant program data on a quarterly basis.[Footnote
45] For example, the new Medicare regulations require transplant
centers to be OPTN members, so the OPTN is providing data on the status
of each transplant center's membership in the OPTN. (See table 3.)
Table 3: Medicare Requirements for Transplant Programs for Which the
OPTN Is Providing Data to CMS:
Medicare requirement: Transplant programs must be a member of the OPTN;
Data provided to CMS on each OPTN member: OPTN membership status.
Medicare requirement: Transplant programs must submit OPTN-required
data to the OPTN within 90 days of OPTN deadlines;
Data provided to CMS on each OPTN member: Member's compliance with OPTN
data submission policies.
Medicare requirement: The hospital in which a transplant program
operates must have a written agreement with an organ procurement
organization to receive organs;
Data provided to CMS on each OPTN member: The organ procurement
organization with which the transplant center has an agreement.
Medicare requirement: Transplant programs must ensure that all
individuals who provide services at the program, supervise services, or
both are qualified to provide or supervise such services;
Data provided to CMS on each OPTN member: The names of the primary
surgeon and primary physician at the transplant program.
Source: GAO analysis of Medicare CoPs for transplant centers and
information from CMS and HRSA.
[End of table]
While this basic data sharing represents progress, CMS, HRSA, and the
OPTN have additional information resulting from their oversight
activities that could be shared. The exchange of this information is
important because CMS and the OPTN conduct different monitoring
activities and, as a result, may have different information about
transplant programs that could be relevant to each other. For example,
while both CMS and the OPTN conduct on-site reviews of transplant
programs, the OPTN's on-site reviews focus largely on medical records
review while CMS's on-site surveys are more broadly scoped. If the OPTN
determined during an on-site review that the medical urgency assigned
to patients by a transplant program was not supported by its medical
records, this information could be of interest to CMS if this practice
inappropriately reduced the chances of others on the waiting list to
receive a transplant. As another example, the OPTN and HRSA are working
to put into place their organ acceptance rate indicator, which CMS
officials said they would be interested in using. Information from
CMS's and the OPTN's investigations could also be potentially important
to share. For example, if CMS investigated a complaint from a patient
about the length of time he or she had been waiting for a transplant
and determined that the delay was caused by the program failing to
update the patient's health status, a violation of OPTN policy, the
OPTN might want to flag the program for closer monitoring.
CMS and HRSA have recognized the importance of sharing information from
their oversight activities, but the agencies have not yet reached
agreement on how they would do so. CMS submitted a draft proposal to
HRSA in April 2007 describing how CMS and HRSA could potentially share
information about organ transplant programs. CMS and HRSA officials
have since discussed the initial proposal, including possible
revisions, but their progress has been slow. As of February 2008, CMS
and HRSA had yet to reach agreement or establish a time frame for doing
so. According to HRSA officials it had taken the agencies several
months to better understand each other's oversight processes, and both
agencies needed to further explore their information needs. CMS
officials also indicated that further issues would need to be resolved
before an agreement could be reached.
As part of any agreement to share information from their oversight
activities, CMS and HRSA will need to determine precisely what
information from their oversight activities they will share and at what
point in their oversight processes they will share it. CMS and HRSA
have discussed but not resolved these issues:
* Nature of information to be shared. It will be important for CMS and
HRSA to determine specifically what information they will share from
their oversight activities. For example, while CMS's initial proposal
addressed how CMS and HRSA could share information from CMS's and the
OPTN's investigations of serious complaints, such as those involving
threats to patient health and safety, CMS and HRSA officials have since
discussed whether to share information from all complaints. In
addition, CMS and HRSA have not determined to what extent information
from routine inspections, such as the OPTN's on-site reviews and CMS's
on-site surveys, will be shared and at what level of detail. For
example, CMS's initial proposal called for CMS to notify the OPTN about
its completed on-site surveys and to indicate whether the transplant
program surveyed had a plan of correction, but it did not call for CMS
to provide information on the deficiencies CMS found. HRSA officials
have since expressed their interest in having this more detailed
information.
* Timing of information sharing. A more difficult challenge that CMS
and HRSA face is agreeing when to share information about potential
problems at transplant programs. Officials from both CMS and HRSA
consider the severity of the identified problem(s) with a program to be
a key factor in determining the appropriate time for information
sharing. In this regard, officials from both agencies stated a
willingness to promptly share information on potentially serious
problems. Agreeing on just when to exchange information on less serious
problems has been more problematic for the agencies in part because of
differences in their approaches to oversight. On the one hand, CMS
officials emphasize their agency's obligation to investigate any
indications of noncompliance with Medicare requirements and prefer to
be notified as soon as possible if the OPTN discovers a potential
problem indicating noncompliance with Medicare CoPs. On the other hand,
HRSA officials have emphasized that the viability and success of the
OPTN's performance improvement process depends upon transplant programs
sharing openly about their practices or past events. HRSA officials
contend that the possibility of such information being shared with CMS,
a regulatory agency, could cause transplant programs to be less candid
about discussing real or potential problems, making it more difficult
for the OPTN to help them return to compliance.
Conclusions:
CMS, HRSA, and the OPTN recognize the gaps in oversight that existed
when serious problems were exposed at transplant centers and have taken
significant steps to strengthen federal oversight. The actions they
have taken will help improve standards for transplant programs and
should improve detection of potential problems. These actions include
CMS's issuance of new regulations that expand and update requirements
for transplant programs. In addition, CMS plans to conduct on-site
surveys of all transplant programs seeking initial Medicare approval
under the new regulations and to regularly review certain transplant
program data, which should reduce the chances of problems going
undetected by the agency. Similarly, if the OPTN's and HRSA's efforts
to develop and implement a set of activity-level indicators to detect
problems that prolong the time patients wait for transplants are
successful, the indicators will likely result in earlier detection of
these more subtle problems.
The full effect of these planned improvements, however, is unknown at
this time, and much has yet to be accomplished. While surveyors have
begun conducting on-site surveys for initial Medicare approval, CMS
expects these surveys may take 3 years to complete. CMS is still in the
process of designing its tracking system for transplant programs, and
it is important that the system include mechanisms to check that
transplant programs remain accurately classified in the CMS survey
database over time. The OPTN and HRSA are working on implementing their
set of activity-level indicators for kidney and liver transplant
programs. It will be important for the OPTN and HRSA to implement the
activity-level indicators to the extent feasible to provide improved
monitoring tools to detect problems affecting patient access to
transplants like those involved in the high-profile cases in 2005 and
2006. Attending to these areas is critical for effective oversight, and
we encourage CMS, HRSA, and the OPTN to continue their efforts to
implement these initiatives.
Of more concern are two other issues. The first is how CMS will
ultimately conduct on-site surveys for transplant programs seeking
reapproval under the new Medicare regulations. Under the regulations,
CMS may choose not to conduct such surveys for transplant programs
meeting data submission, clinical experience, and outcomes
requirements. Not conducting on-site reapproval surveys may limit CMS's
ability to monitor these transplant programs' compliance with other
Medicare CoPs, for example, whether transplant programs are providing
required protections for living donors, and to detect problems like
those involved in some of the high-profile cases. CMS has not yet
developed a process to determine the scope of the transplant programs
(number or type) to be included in reapproval surveys or the criteria
for determining which, if any, transplant programs that meet the three
requirements will receive such surveys. Given the potential importance
of these reapproval surveys, we believe that having a methodology that
ensures that CMS conducts surveys of at least some transplant programs
meeting the three requirements is critical to maximize CMS's
opportunities to identify potential problems in a timely manner.
We also have a concern about the pace of progress being made to share
information about the oversight activities of CMS, HRSA, and the OPTN.
Agency officials believe, as we do, that their ability to identify
potential problems could be enhanced by sharing information resulting
from their oversight activities. While CMS's draft proposal for sharing
such information is an important first step in reaching an agreement on
this issue, CMS and HRSA have yet to finalize an agreement or establish
a time frame for doing so. Without a definitive time frame for reaching
agreement, there is increased risk that the negotiation process among
these agencies could languish, and they could miss opportunities to
detect and remedy problems with transplant programs. Furthermore, in
developing an agreement, CMS and HRSA will need to fully articulate
what types of information will be shared from their oversight
activities and when they will share it. While we agree that there are
challenges associated with reaching agreement on this issue, we also
believe it is important to settle these issues and finalize a clear
written agreement that maximizes information sharing as appropriate and
better ensures that all parties are aware of critical information in
time to take appropriate action. Once CMS and HRSA reach and implement
an agreement, they may wish to periodically assess how effectively it
is working for each of them to improve their oversight.
Recommendations for Executive Action:
To improve federal oversight of organ transplant programs, we recommend
that the Secretary of Health and Human Services:
(1) Direct the Administrator of CMS to develop a methodology for
conducting on-site surveys of transplant programs seeking Medicare
reapproval that ensures that at least some transplant programs meeting
data submission, clinical experience, and outcomes requirements receive
on-site surveys.
(2) Direct the Administrators of CMS and HRSA to establish a time frame
for finalizing an agreement for the agencies to share information
resulting from CMS's and the OPTN's oversight activities. The agreement
should, at a minimum,
* specify the types of information CMS, HRSA, and the OPTN will share
and:
* specify at what point in CMS's and the OPTN's oversight processes
this information will be exchanged.
Agency Comments:
We received comments on a draft of this report from HHS. (See app. II.)
The department concurred with both of our recommendations and commented
that CMS recognizes the need to increase its oversight of organ
transplant programs.
HHS agreed with our recommendation that CMS develop a methodology for
conducting on-site surveys for Medicare reapproval to ensure that at
least some programs meeting certain Medicare criteria are surveyed,
noting that CMS has developed an initial framework for doing so but
that its implementation will depend on the resources available for
survey and certification activities. CMS highlighted several factors
the agency may use as part of a methodology to determine survey
frequencies for individual transplant programs, including prior survey
results, program changes, program indicators, and the time interval
since the last survey.
HHS also agreed with our recommendation to establish a time frame for
finalizing the agreement between HRSA and CMS to share information from
their oversight activities, noting that HRSA and CMS have been working
to develop and finalize such an agreement. Specifically, the department
commented that CMS has conveyed a proposal to HRSA regarding the
criteria and process that CMS would use in sharing information, and
that CMS would like the agreement with HRSA to be finalized by June 30,
2008. HHS also noted that even though a formal agreement is not yet in
place, CMS and HRSA have on several occasions already shared oversight
information about particular programs.
The department also provided technical comments, which we incorporated
as appropriate.
As arranged with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 30
days after its date. At that time, we will send copies of this report
to the Secretary of Health and Human Services, the Administrators of
CMS and HRSA, and appropriate congressional committees. We will also
provide copies to others upon request. In addition, the report is
available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staff members have any questions about this report,
please contact me at (202) 512-7114 or williamsonr@gao.gov. GAO staff
who made major contributions to this report are listed in appendix III.
Sincerely yours,
Signed by:
Randall B. Williamson:
Director, Health Care:
[End of section]
Appendix I: Medicare Conditions of Participation for Transplant
Centers:
On March 30, 2007, the Centers for Medicare & Medicaid Services (CMS)
published a final rule promulgating requirements for Medicare approval
and reapproval of transplant centers to perform organ transplants. The
regulations, which became effective June 28, 2007, delineate Medicare
conditions of participation for heart, heart-lung, intestine, kidney,
liver, lung, and pancreas transplant centers.[Footnote 46] Table 4
presents a summary of the key requirements for each condition of
participation.
Table 4: Summary of Medicare Conditions of Participation for Transplant
Centers:
Title of condition of participation: Organ Procurement and
Transplantation Network (OPTN) membership;
Summary of requirements: The transplant program must be located in a
hospital that is a member of the OPTN and that abides by the approved
rules and requirements of the OPTN.
Title of condition of participation: Notification to CMS;
Summary of requirements: The transplant program must notify CMS of any
significant changes related to the program or changes that could affect
its compliance with the Medicare conditions of participation.
Title of condition of participation: Pediatric transplants;
Summary of requirements: A transplant program seeking to perform
pediatric transplants must apply for specific approval to do so.
Title of condition of participation: Data submission, clinical
experience, and outcomes requirements for initial approval;
Summary of requirements: For initial Medicare approval:
* The transplant program must submit required data to the OPTN within a
specified time frame;
* Adult heart, liver, lung, and intestine transplant programs must
generally perform 10 transplants over a 12-month period; adult kidney
transplant programs must perform at least 3 transplants over a 12-month
period prior to their request for initial approval;
* Heart, liver, lung, and kidney transplant programs must have
acceptable patient and graft (transplanted organ) survival rates.[A]
Title of condition of participation: Data submission, clinical
experience, and outcomes requirements for reapproval;
Summary of requirements: To renew Medicare approval:
* The transplant program must submit required data to the OPTN within a
specified time frame;
* Adult heart, liver, lung, intestine, and kidney transplant programs
must perform an average of 10 transplants per year;
* Heart, liver, lung, and kidney transplant programs must have
acceptable patient and graft survival rates.[A]
Title of condition of participation: Patient and living donor
selection;
Summary of requirements: The transplant program must use written
patient selection criteria and, if applicable, written living donor
selection criteria. Patient selection criteria must assure a
nondiscriminatory distribution of organs. Living donor selection
criteria must be consistent with principles of medical ethics.
Title of condition of participation: Organ recovery and receipt;
Summary of requirements: The transplant program must have written
protocols, including documentation of vital information, for recovery
and receipt of organs from deceased donors and for living donor organ
transplantation. The transplanting surgeon is responsible for ensuring
the medical suitability of organs for transplantation into the intended
recipient.
Title of condition of participation: Patient and living donor
management;
Summary of requirements: The transplant program must have written
patient and, if applicable, living donor management policies; keep
patient waiting lists and medical records up to date; and provide
social and nutritional services to patients and donors.
Title of condition of participation: Quality assessment and performance
improvement;
Summary of requirements: The transplant program must develop,
implement, and maintain a quality assessment and performance
improvement program to monitor and evaluate its transplantation
services.
Title of condition of participation: Human resources;
Summary of requirements: The transplant program must ensure that staff,
including the program director, primary transplant surgeon and
physician, clinical transplant coordinator, and living donor advocate
are qualified and meet CMS-specified requirements.
Title of condition of participation: Organ procurement;
Summary of requirements: The hospital containing the transplant program
must have a written agreement with an organ procurement organization
designated by the Secretary of Health and Human Services.
Title of condition of participation: Patient and living donor rights;
Summary of requirements: The transplant program must protect and
promote patient and living donor rights through the implementation of
informed consent policies, and must notify patients about factors that
could affect patient access to transplantation, such as termination of
Medicare approval or that the program is served by a single surgeon.
Title of condition of participation: Additional requirements for kidney
transplant centers;
Summary of requirements: Kidney transplant programs must furnish
dialysis services and other care to end-stage renal disease patients.
Source: GAO analysis of Medicare hospital conditions of participation
for transplant centers.
[A] CMS will compare data on observed patient deaths and graft failures
1-year post-transplant to the expected number of deaths and graft
failures 1-year post-transplant calculated by the Scientific Registry
of Transplant Recipients, which uses risk-adjusted statistical models.
CMS will consider patient and graft survival rates to be unacceptable
if the observed patient or survival rate is lower than expected and all
three of the following are true: (1) the one-sided p-value is less than
0.05, (2) the number of observed events (patient deaths or graft
failures) minus the number of expected events is greater than 3, and
(3) the number of observed events divided by the number of expected
events is greater than 1.5.
[End of table]
[End of section]
Appendix II: Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office of the Assistant Secretary for Legislation:
Washington, DC 20201:
April 14, 2008:
Randall Williamson:
Acting Director, Health Care:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Mr. Williamson:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) report entitled: Organ Transplant
Programs: Federal Agencies Have Acted to Improve Oversight but
Implementation Issues Remain" (GAO 08-412).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
Jennifer R. Luong, for:
Vincent Ventimiglia:
Assistant Secretary for Legislation:
[End of letter]
Department Of Health & Human Services:
Centers for Medicare S Medicaid Services:
Administrator:
Washington, DC 20201:
Date: April 14, 2008:
To: Randall Williamson:
Acting Director, Health Care:
Government Accountability Office:
From: [Signed by] Kerry Weems:
Acting Administrator:
Subject: Government Accountability Office (GAO) Draft Report: "Organ
Transplant Programs: Federal Agencies Have Acted to Improve Oversight
but Implementation Issues Remain" (GAO-08-412):
Thank you for the opportunity to comment on the subject GAO Draft
Report. The purpose of the report was to examine (l) Federal oversight
of transplant programs at the time several high-profile organ
transplant cases came to light in 2005 and 2006; and (2) changes that
Federal agencies have made or planned since then to strengthen
oversight.
The Centers for Medicare and Medicaid Services (CMS) recognizes the
need to increase our oversight of organ transplant programs, and
appreciates GAO's description of our considerable efforts over the past
18 months to strengthen oversight of hospital transplant programs, such
as the following:
* Review of Extra-Renal Programs under the National Coverage
Determinations: In 2006, CMS notified 11 extra-renal transplant
programs that their Medicare approval was in jeopardy due to failure to
comply with the National Coverage Determinations. As discussed in the
GAO report, Medicare participation ended (either voluntarily or
involuntarily) for 3 of those programs. The remaining 8 programs have
submitted corrective action plans that were approved, and continue to
be monitored, by CMS.
* Release of Regulation Establishing Organ Transplant Conditions of
Participation: In March 2007, CMS published new Conditions of
Participation (CoPs) for organ transplant programs. The CoPs
established one set of 13 minimum requirements that all transplant
programs must meet in order to participate in Medicare.
* Development of Surveyor Guidance: In 2007, CMS developed detailed
guidance for surveyors who conduct the onsite review of transplant
programs to assist in their determination of program compliance with
the CoP. This guidance outlines the sources of evidence (e.g.,
policies, procedures, medical records) that surveyors will review to
evaluate compliance with each Condition of the regulation.
* Coordination between CMS and the Health Resources and Services
Administration (HRSA): In April 2007, CMS and HRSA began a dialogue to
address the areas where our separate regulatory responsibilities
intersect and discuss how coordination/collaboration could reinforce
each agency's oversight efforts in this area. CMS and HRSA have agreed
to exchange program information quarterly, and are continuing
discussions about the exchange of case-specific information (e.g.,
complaints).
* Survey Implementation: In August 2007, CMS trained 66 surveyors to
perform transplant program surveys. The onsite transplant surveys began
in August 2007, and are ongoing. State survey agencies are conducting
the surveys in most States, while a national contractor is conducting
surveys in others.
* Continued Improvement: We continue to benefit from feedback from
surveyors, professional associations, States, transplant programs, and
the public as we review early survey experience and work to improve our
interpretive guidance for surveyors.
The GAO report makes two recommendations for the CMS consideration.
These recommendations and our responses to these recommendations are
listed below.
Recommendation #1: CMS should develop a methodology for conducting on-
site surveys for Medicare re-approval to ensure that at least some
programs meeting certain Medicare criteria are surveyed.
CMS Response: The CMS concurs with this recommendation. We have already
developed an initial framework for doing so, but implementation of the
methodology will depend on the resources available for survey and
certification (S&C) activities. As you may know, the current level of
survey activity for transplant programs was initiated by CMS without
explicit fiscal support from Congress. We sincerely hope that the
necessary resources will be available to enable us to maintain this
level of S&C frequency for transplant programs.
At the present time we are implementing onsite surveys based on a 3-
year survey and certification cycle. This means that re-approval
surveys will begin in fiscal year (FY) 2010 for those transplant
programs first surveyed in FY 2007. Ideally, we would be able to
continue the re-certification surveys on the same 3-year cycle, on
average, depending on the budget.
However, as discussed in the GAO report, the regulation permits CMS to
make future survey and compliance determinations based on other
factors. Even with a 3-year survey cycle on average, we plan to adjust
survey frequencies for any specific transplant program taking into
account past compliance with regulatory requirements. For example, such
factors may include the following:
* Prior Survey Results: In some cases, the findings from a prior survey
would warrant more frequent or less frequent onsite review to verify
that compliance with the CoP is maintained.
* Program Changes: On an ongoing basis, transplant programs are
required to report significant program changes that may affect
compliance with the CoP (e.g., key personnel changes, inactivity). Such
reports may indicate a period of transition for a transplant program.
CMS would want to consider reviewing transplant programs that have been
through a significant transition since their last onsite survey to
ensure that the CoP continue to be met.
* Program Indicators: Every 6 months, the Scientific Registry of
Transplant Recipients (SRTR) publishes reports that provide key program
information, such as: outcome data, how long individuals at that
program wait for an organ transplant, how many individuals have
received transplants, what the patient mortality rate at that program
is for individuals on the waiting list, etc. These reports compare a
program's information with others in their region and with the national
average. We expect that these data would be used to develop indicators
where potential issues may exist, and where an onsite review would be
most important.
* Interval Since the Last Survey: After the first re-approval period,
CMS will consider the time that has elapsed since a program's last
onsite survey, as well as intervening complaints that have been
substantiated through a complaint investigation.
Recommendation #2: Establish a timeframe for finalizing the agreement
between HRSA and CMS to share information from our oversight
activities.
CMS Response: The CMS agrees with this recommendation. CMS and HRSA
have been working to develop and finalize an agreement regarding the
sharing of information from our mutual oversight activities. We have
made significant progress on the content and format for sharing
transplant program data on a quarterly basis (as described in the GAO
report), and we are hopeful that we are close to an agreement outlining
the criteria and process for sharing case-specific notifications of
program changes, complaints, and inactivity.
We have conveyed to HRSA a proposal regarding the criteria and process
that CMS would use in sharing information regarding specific cases.
This would include communicating at an early stage in cases of high-
profile incidences, incidences of gross negligence, or a program's
inactivity, and routinely sharing CMS survey findings that identify
that a program is out of compliance with one or more Medicare CoP. The
results of any other survey finding would be shared with HRSA upon
request. We hope that the agreement can be finalized between CMS and
HRSA by June 30, 2008.
Even though a formal agreement is not yet in place, neither CMS nor
HRSA is waiting for such an agreement to work together in sharing
information that results from our oversight activities. Since the
onsite surveys have started, there have been several occasions where
CMS and HRSA have discussed a particular program's status or
investigated a complaint that has been referred to us.
We thank the GAO staff for their work in this important area of federal
health care purchasing and oversight.
[End of letter]
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Randall B. Williamson, (202) 512-7114 or williamsonr@gao.gov:
Acknowledgments:
In addition to the contact named above, Kim Yamane, Assistant Director;
Emily Beller; Susannah Bloch; George Bogart; Manuel Buentello; Linda
McIver; Colin Smith; Stanley Stenersen; and Suzanne Worth made key
contributions to this report.
[End of section]
Footnotes:
[1] In 2007, 14,393 individuals (deceased and living) donated one or
more organs.
[2] The United Network for Organ Sharing (UNOS), a nonprofit
organization, administers the OPTN under contract with HRSA. We use the
OPTN to refer to the OPTN, UNOS, or both and OPTN officials to refer to
OPTN officials, UNOS officials responsible for administering the OPTN,
or both.
[3] The OPTN's expectations for its members are specified in OPTN
policies and OPTN bylaws. In this report, we refer to both OPTN
policies and OPTN bylaws as OPTN policies.
[4] CMS was known as the Health Care Financing Administration prior to
June 14, 2001. In this report, we use CMS to refer to activities of
both CMS and the Heath Care Financing Administration.
[5] Medicare is a federal program that finances health care for people
aged 65 years or older and for younger people with disabilities and
people with end-stage renal disease (permanent kidney failure requiring
dialysis or transplantation).
[6] Based on CMS and OPTN data, we estimate that about 80 percent of
transplant programs are Medicare approved.
[7] For purposes of this report, we consider federal agencies'
oversight of organ transplant programs to include the oversight
activities conducted by CMS, HRSA, and the OPTN.
[8] We excluded from our review oversight of transplant programs under
CMS's Medicaid program, the joint federal-state program that finances
health care for certain low-income individuals. According to CMS
officials, oversight of transplant programs that receive Medicaid
reimbursement is handled by state Medicaid programs. We also did not
examine the OPTN's, HRSA's, or CMS's oversight of organ procurement
organizations, which are responsible for the retrieval, preservation,
and transportation of donated organs.
[9] A total of 81 transplant centers had compliance cases from 2003
through 2006. We randomly selected 27 of the 81 centers and
supplemented the random sample by including all additional compliance
cases from transplant centers where the OPTN took strong enforcement
actions from 2000 through 2006 that were not already included in the
random sample (4 centers). Some transplant centers had multiple cases
reviewed by the OPTN at that time; we reviewed all 43 cases associated
with the 31 transplant centers we selected.
[10] Pancreas transplant programs are extra-renal transplant programs,
but CMS officials stated that its surveys of renal (kidney) transplant
programs are in effect reviews of pancreas transplant programs, noting
that Medicare-approved pancreas transplants have largely been performed
by Medicare-approved kidney transplant programs. For example, according
to CMS, since 2003, no Medicare-approved pancreas transplant had been
performed outside of a Medicare-approved kidney transplant program. For
the purposes of this report, when we refer to CMS's monitoring of extra-
renal transplant programs we mean its monitoring of heart, liver, lung,
and intestine transplant programs.
[11] Medical urgency is measured differently for different organs,
according to criteria established by the OPTN, and may include such
factors as life expectancy and intensity of current treatment.
[12] Pub. L. No. 98-507, § 201, 98 Stat. 2339, 2342 (1984) (codified as
amended at 42 U.S.C. § 274). The Secretary of Health and Human Services
delegated this responsibility to HRSA.
[13] Tissue-typing laboratories test potential donors and recipients
for tissue compatibility. Tissue typing is routinely performed for all
donors and recipients in kidney and pancreas transplantation to help
match the donor with the most suitable recipients in order to decrease
the likelihood of organ rejection.
[14] 42 U.S.C. § 274(a).
[15] HHS initially published an OPTN final rule on April 2, 1998, 63
Fed. Reg. 16332 (to be codified at 42 C.F.R. pt. 121). The rule was
later amended on October 20, 1999 (64 Fed. Reg. 56658), and then became
effective on March 16, 2000.
[16] Under a 1986 addition to the Social Security Act, hospitals that
participate in Medicare and Medicaid and perform organ transplants are
required to be members of and abide by the rules of the OPTN. Pub. L.
No. 99-509, § 9318, 100 Stat. 1874, 2009 (adding section 1138 to the
Social Security Act) (codified as amended at 42 U.S.C. § 1320b-8). HHS
interpreted this provision to require that to be considered a rule or
requirement of the OPTN and therefore binding on participating
hospitals, the rule or requirement must be formally approved by the
Secretary. 54 Fed. Reg. 51802 (Dec. 18, 1989); see also 42 C.F.R. §
121.4(b)(2) and (c) (2007) (regulation providing framework for
submission of OPTN policies to the Secretary for review and approval).
As of February 2008, the Secretary had not approved any OPTN policies
for this purpose. Although OPTN policies have not been formally
approved by the Secretary, HRSA has indicated that certain data
submitted to the OPTN are mandatory under 42 C.F.R. § 121.11(b)(2) and
that failure to submit these data accurately and completely could be
considered a violation of this section.
[17] This process is referred to in OPTN policies as confidential
medical peer review.
[18] The OPTN contract does not require on-site reviews of kidney
transplant programs. Kidney transplant programs are different from
other programs in that kidney allocation is determined, in part, by the
amount of time the patient has been waiting, not the severity of the
patient's illness. OPTN officials said that kidney transplant programs
are reviewed on-site if they are part of a transplant center where the
OPTN is reviewing other transplant programs.
[19] Medicare NCDs were published extending coverage to participating
and qualified facilities performing heart transplants in 1987, liver
transplants in 1991, lung transplants in 1995, pancreas transplants
simultaneous with or after kidney transplants in 1999, isolated
intestinal and combined liver-intestinal transplants in 2001, and
pancreas transplants alone in 2006. 52 Fed. Reg. 10935 (Apr. 6, 1987)
(heart); 56 Fed. Reg. 15006 (Apr. 12, 1991) (liver); 60 Fed. Reg. 6537
(Feb. 2, 1995) (lung); CMS Program Memorandum, Transmittal A-99-16
(Apr. 1999) (pancreas simultaneous with or after kidney); CMS Program
Memorandum, Transmittal AB-01-58 (Apr. 12, 2001) (intestinal and
multivisceral, including combined liver-intestinal); and CMS Pub. 100-
03, Transmittal 56 (May 19, 2006) (pancreas). Revised transplant volume
requirements for heart, liver, and lung transplant programs were issued
on October 11, 2000. CMS Program Memorandum, Transmittal AB-00-95 (Oct.
11, 2000).
[20] See 42 C.F.R. pt. 405, subpt. U (2006).
[21] Most ESRD facilities are renal dialysis facilities, but a small
subset of ESRD facilities operate renal transplant programs.
[22] The state agencies are often responsible for surveying other types
of health care facilities that require certification for participation
in Medicare or Medicaid, such as nursing homes and home health
agencies.
[23] CMS initially published a transplant center proposed rule for
comment on February 4, 2005. 70 Fed. Reg. 6140. After a comment period,
CMS published a final rule on March 30, 2007 (72 Fed. Reg. 15198)
(codified at 42. C.F.R. pts. 405, 482, 488, and 498) that became
effective on June 28, 2007.
[24] Criteria for Medicare approval differed by program type. In its
NCDs, CMS established the criteria that lung and intestine transplant
programs should conduct at least 10 transplants per year, and heart and
liver transplant programs should conduct at least 12 transplants per
year. The criteria for 1-year survival rates for patients after
transplantation were 69 percent or higher for lung transplant programs,
65 percent or higher for intestine transplant programs, 73 percent or
higher for heart transplant programs, and 77 percent or higher for
liver transplant programs.
[25] The earliest possible date of initial Medicare approval was 1986
for heart programs, 1990 for liver programs, 1995 for lung programs,
and 2001 for intestine programs.
[26] One CMS regional office reported conducting no complaint
investigations of extra-renal transplant programs; another reported
that it did not track them. CMS officials also reported conducting
several complaint investigations of renal transplant programs.
[27] The Medicare requirements for ESRD facilities addressed issues
relevant to all ESRD facilities, such as the maintenance of medical
records; they also addressed a limited number of requirements specific
to renal transplant programs, such as that the transplant program
perform a minimum number of transplants per year, be under the
direction of a qualified transplant surgeon or physician, and meet
minimal service requirements, including participation in a patient
organ allocation registry and provision of social, dietetic, and
laboratory services.
[28] See, for example, Institute of Medicine, Organ Procurement and
Transplantation: Assessing Current Policies and the Potential Impact of
the DHHS Final Rule (Washington, D.C.: National Academies Press, 1999).
[29] Other areas not addressed in the Medicare requirements for ESRD
facilities included protections for the safety of living donors, which
since 1990 have become the fastest growing source of kidneys for kidney
transplants, and implementation of quality assessment and performance
improvement programs, now widely used to improve delivery of health
care services. CMS recognized the need both to expand and update its
requirements for renal and extra-renal transplant programs and to
standardize requirements for all types of programs, and began working
on new requirements in 2000. CMS had published a proposed version for
public comment but had not finalized or implemented these requirements
when serious problems came to light in 2005 (the requirements were
later finalized in March 2007).
[30] Twenty-seven of the 31 programs were mistakenly classified as no
longer participating in Medicare and 4 programs were mistakenly
excluded from the survey database. According to CMS officials, the
misclassifications likely resulted from state survey agencies
mistakenly terminating the ESRD Medicare identification number for the
renal transplant program when an associated dialysis program was closed
or sold (a renal transplant program and a dialysis program within the
same facility were tracked under the same ESRD Medicare identification
number). Officials said that this misclassification did not affect
renal transplant programs' ability to receive Medicare reimbursement
because programs with terminated ESRD identification numbers could
continue billing Medicare through their hospital identification
numbers.
[31] CMS's goals for ESRD facilities have varied in recent years. For
example, in fiscal years 2006 and 2007 CMS had a goal that state
agencies assign high priority to surveys of a subset (10 percent) of
low-performing ESRD facilities targeted by CMS, as well as a goal that
state agencies survey all ESRD facilities every 3.5 years on average;
in fiscal years 2004 and 2005 CMS had a goal that state agencies survey
all ESRD facilities every 3 years on average.
[32] Until September 2005, the goal to conduct periodic routine on-site
reviews was limited to heart and liver programs because patients'
priority on the waiting list for these organs depended primarily on
medical urgency. The September 2005 OPTN contract incorporated the
OPTN's goal of conducting on-site reviews every 3 years and included
lung programs in addition to heart and liver programs, after a policy
change in which patients' priority on the waiting list for lung
transplants would likewise depend upon medical urgency.
[33] The OPTN's monitoring also detected performance problems involving
low patient survival rates at another transplant program involved in a
high-profile case, although this monitoring did not enable the OPTN to
promptly identify the full scope of the problem. (A CMS complaint
survey later found that the transplant program did not have a full-time
transplant surgeon on staff.)
[34] The period of time ranges from 3 to 12 months, depending on the
type of transplant program.
[35] The OPTN had previously identified performance problems at one of
these two programs, but the program's survival rates improved and the
OPTN released the program from review a few months prior to the time
that the staffing problem came to light.
[36] In 2005, the OPTN changed the way it identified programs for
additional review. Before 2005, transplant programs flagged as having
lower-than-expected outcomes in two consecutive quarterly reports were
identified for additional review. As of October 2005, programs flagged
as having lower-than-expected outcomes in one report were identified
for additional review.
[37] CMS officials reported that they reviewed circumstances at
transplant programs on a case-by-case basis to decide which cases
constituted egregious noncompliance, and that there were no explicit
criteria with which to make this decision.
[38] Transplant programs that were Medicare approved as of June 28,
2007, were required to apply for approval under the new regulations by
December 26, 2007, to maintain their Medicare approval until CMS could
act on their applications.
[39] According to CMS officials, CMS also plans to monitor compliance
with these requirements, and others with which compliance can be
monitored using available data, on an ongoing basis during the 3-year
approval period.
[40] CMS will consider patient and graft survival rates to be
unacceptable if the observed patient or survival rate is lower than
expected and all three of the following are true: (1) the one-sided p-
value is less than 0.05, (2) the number of observed events (patient
deaths or graft failures) minus the number of expected events is
greater than 3, and (3) the number of observed events divided by the
number of expected events is greater than 1.5.
[41] According to CMS, for initial approval the agency generally will
not approve programs that do not meet the data submission, clinical
experience, and outcome standards, but the regulations also provide for
the consideration of mitigating factors.
[42] Transplant programs that want to continue to be Medicare approved,
however, must be in compliance with the new regulations as of June 28,
2007, and must have submitted a request to CMS for Medicare approval
under the CoPs no later than December 26, 2007.
[43] On-site surveys in about half of the states will be conducted by
state agencies; in the other states, CMS has assigned a contractor to
conduct the surveys.
[44] CMS sets priorities for state survey agency workload based on
tiers, where Tier 1 is the highest priority and Tier 4 the lowest. In
2007, CMS prioritized surveys of transplant programs at Tier 2.
[45] Another HRSA contractor is providing CMS with quarterly data on
transplant programs' survival rates and transplant activity.
[46] 72 Fed. Reg. 15198 (codified in pertinent part at 42 C.F.R. pt.
482, subpt. E).
[End of section]
GAO's Mission:
The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting
its constitutional responsibilities and to help improve the performance
and accountability of the federal government for the American people.
GAO examines the use of public funds; evaluates federal programs and
policies; and provides analyses, recommendations, and other assistance
to help Congress make informed oversight, policy, and funding
decisions. GAO's commitment to good government is reflected in its core
values of accountability, integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through GAO's Web site [hyperlink, http://www.gao.gov]. Each
weekday, GAO posts newly released reports, testimony, and
correspondence on its Web site. To have GAO e-mail you a list of newly
posted products every afternoon, go to [hyperlink, http://www.gao.gov]
and select "E-mail Updates."
Order by Mail or Phone:
The first copy of each printed report is free. Additional copies are $2
each. A check or money order should be made out to the Superintendent
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or
more copies mailed to a single address are discounted 25 percent.
Orders should be sent to:
U.S. Government Accountability Office:
441 G Street NW, Room LM:
Washington, D.C. 20548:
To order by Phone:
Voice: (202) 512-6000:
TDD: (202) 512-2537:
Fax: (202) 512-6061:
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]:
E-mail: fraudnet@gao.gov:
Automated answering system: (800) 424-5454 or (202) 512-7470:
Congressional Relations:
Ralph Dawn, Managing Director, dawnr@gao.gov:
(202) 512-4400:
U.S. Government Accountability Office:
441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548:
