End-Stage Renal Disease
Characteristics of Kidney Transplant Recipients, Frequency of Transplant Failures, and Cost to Medicare Gao ID: GAO-07-1117 September 28, 2007For individuals with end-stage renal disease (ESRD), the permanent loss of kidney function, Medicare covers kidney transplants and 36 months of follow-up care. Kidney transplant recipients must take costly medications to avoid transplant failure. Unless a transplant recipient is eligible for Medicare other than on the basis of ESRD, Medicare coverage, including that for medications, ends 36 months posttransplant. Pediatric transplant recipients, including those who were under 18 when transplanted but are now adults (transitional recipients), may be more likely than their adult counterparts to lose access to medications once Medicare coverage ends because they may lack access to other health insurance coverage. GAO was asked to examine (1) the percentage of transplant failures and subsequent outcomes--retransplant, dialysis, or death--among pediatric, transitional, and adult kidney transplant recipients and (2) how the cost to Medicare for a beneficiary with a functioning transplant compares with the cost for a beneficiary with a transplant failure. To do this, GAO analyzed 1997 through 2004 data from the United States Renal Data System (USRDS) and interviewed officials from pediatric transplant centers. The Centers for Medicare & Medicaid Services--the agency that administers Medicare--commented that it is concerned about beneficiary outcomes and has an education program to help them.
The percentage of kidney transplant recipients who experience a transplant failure varies by age group as do the percentages who experience dialysis, retransplant, or death. After the first year posttransplant, a higher percentage of transitional recipients (those younger than 18 at the time of their transplants and at least 18 as of December 31, 2004) experienced a transplant failure and subsequently received dialysis compared with their pediatric (those younger than 18 as of December 31, 2004) and adult (those at least 18 at the time of their transplants) counterparts. By 5 years posttransplant, the percentage of transitional recipients who experienced a transplant failure (33 percent) was about twice as high as pediatric recipients (16 percent) and somewhat higher than adult recipients (28 percent). The largest increase in transplant failures for each age group occurred in the first 3 years posttransplant--before the termination of Medicare coverage on the basis of ESRD--and the increase was substantially higher for transitional recipients (133 percent) than for pediatric (83 percent) and adult (100 percent) recipients. Medicare beneficiaries with functioning transplants cost substantially less per year to treat than those who experienced a transplant failure. GAO found that the median annual Medicare cost for a beneficiary whose transplant failed ($50,938) was 500 percent more than the median annual Medicare cost for a beneficiary with a functioning transplant ($8,550). This percentage difference was consistent across transplant recipient age groups. The substantial cost of treating transplant recipients who experience a transplant failure underscores the importance of maintaining functioning kidney transplants. While there are many reasons that could account for transplant failures, the large percentage increase in transplant failures from 1 year to 3 years posttransplant for transitional recipients cannot be attributed to an inability to access medications due to a lack of Medicare coverage.
GAO-07-1117, End-Stage Renal Disease: Characteristics of Kidney Transplant Recipients, Frequency of Transplant Failures, and Cost to Medicare
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
September 2007:
End-Stage Renal Disease:
Characteristics of Kidney Transplant Recipients, Frequency of
Transplant Failures, and Cost to Medicare:
End-Stage Renal Disease:
GAO-07-1117:
GAO Highlights:
Highlights of GAO-07-1117, a report to congressional requesters.
Why GAO Did This Study:
For individuals with end-stage renal disease (ESRD), the permanent loss
of kidney function, Medicare covers kidney transplants and 36 months of
follow-up care. Kidney transplant recipients must take costly
medications to avoid transplant failure. Unless a transplant recipient
is eligible for Medicare other than on the basis of ESRD, Medicare
coverage, including that for medications, ends 36 months
posttransplant. Pediatric transplant recipients, including those who
were under 18 when transplanted but are now adults (transitional
recipients), may be more likely than their adult counterparts to lose
access to medications once Medicare coverage ends because they may lack
access to other health insurance coverage. GAO was asked to examine (1)
the percentage of transplant failures and subsequent
outcomes”retransplant, dialysis, or death”among pediatric,
transitional, and adult kidney transplant recipients and (2) how the
cost to Medicare for a beneficiary with a functioning transplant
compares with the cost for a beneficiary with a transplant failure. To
do this, GAO analyzed 1997 through 2004 data from the United States
Renal Data System (USRDS) and interviewed officials from pediatric
transplant centers.
The Centers for Medicare & Medicaid Services”the agency that
administers Medicare”commented that it is concerned about beneficiary
outcomes and has an education program to help them
What GAO Found:
The percentage of kidney transplant recipients who experience a
transplant failure varies by age group as do the percentages who
experience dialysis, retransplant, or death. After the first year
posttransplant, a higher percentage of transitional recipients (those
younger than 18 at the time of their transplants and at least 18 as of
December 31, 2004) experienced a transplant failure and subsequently
received dialysis compared with their pediatric (those younger than 18
as of December 31, 2004) and adult (those at least 18 at the time of
their transplants) counterparts. By 5 years posttransplant, the
percentage of transitional recipients who experienced a transplant
failure (33 percent) was about twice as high as pediatric recipients
(16 percent) and somewhat higher than adult recipients (28 percent).
The largest increase in transplant failures for each age group occurred
in the first 3 years posttransplant”before the termination of Medicare
coverage on the basis of ESRD”and the increase was substantially higher
for transitional recipients (133 percent) than for pediatric (83
percent) and adult (100 percent) recipients.
Medicare beneficiaries with functioning transplants cost substantially
less per year to treat than those who experienced a transplant failure.
GAO found that the median annual Medicare cost for a beneficiary whose
transplant failed ($50,938) was 500 percent more than the median annual
Medicare cost for a beneficiary with a functioning transplant ($8,550).
This percentage difference was consistent across transplant recipient
age groups.
The substantial cost of treating transplant recipients who experience a
transplant failure underscores the importance of maintaining
functioning kidney transplants. While there are many reasons that could
account for transplant failures, the large percentage increase in
transplant failures from 1 year to 3 years posttransplant for
transitional recipients cannot be attributed to an inability to access
medications due to a lack of Medicare coverage.
Figure: Percentage of Kidney Transplant Recipients Whose Transplants
Failed, by Age Group and Number of Years Posttransplant, 1997-2004:
This figure is a bar chart showing percentages of kidney transplant
recipients whose transplants failed, by age group and number of years
posttransplant, between 1997 and 2004. 6% of pediatric recipients, 9%
of transitional recipient, and 9% of adult recipients had failed
transplants in the first year. 11% of pediatric recipients, 21% of
transitional recipients, and 18% of adult recipients had failed
transplants after three years. 16% of pediatric recipients, 33 percent
of transitional recipients, and 28% of recipients had transplants fail
after five years. 26% of pediatric recipients, 44% of transitional
recipients, and 40% of adult recipients had transplants fail after 7
years.
[See PDF for image]
Source: GAO analysis of USRDS data.
[End of figure]
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.GAO-07-1117]. For more information, contact
Laurie E. Ekstrand at (202) 512-7114 or ekstrandl@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Transplant Recipients in All Age Groups Had Similar Demographic
Characteristics, but Fewer Pediatric and Transitional Recipients Had
Medicare Coverage:
A Higher Percentage of Transitional Recipients Experienced Transplant
Failure and Received Dialysis:
A Higher Percentage of Recipients with Both Medicare and Medicaid
Coverage Experienced Transplant Failure and Received Dialysis:
Beneficiaries with Functioning Transplants Were Substantially Less
Costly to Medicare Than Those with Transplant Failures:
Concluding Observations:
Agency Comments:
Appendix I: Comments from the Centers for Medicare & Medicaid Services:
Appendix II GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Sex:
Table 2: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Race:
Table 3: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Median Annual County-Level Household Income:
Table 4: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Insurance Coverage:
Table 5: Median Annual Medicare Cost per Beneficiary with a Functioning
Transplant and after a Transplant Failure, by Age Group:
Figures:
Figure 1: Percentage of Kidney Transplant Recipients Whose Transplants
Failed, by Age Group and Number of Years Posttransplant:
Figure 2: Percentage of Kidney Transplant Recipients Who Received
Dialysis after Transplant Failure, by Age Group and Number of Years
Posttransplant:
Figure 3: Percentage of Kidney Transplant Recipients Who Received
Retransplants after Transplant Failure, by Age Group and Number of
Years Posttransplant:
Figure 4: Percentage of Kidney Transplant Recipients Who Died after
Transplant Failure, by Age Group and Number of Years Posttransplant:
Figure 5: Percentage of Kidney Transplant Recipients Whose Transplants
Failed, by Type of Health Insurance Coverage and Number of Years
Posttransplant:
Figure 6: Percentage of Kidney Transplant Recipients Who Received
Dialysis after Transplant Failure, by Type of Health Insurance Coverage
and Number of Years Posttransplant:
Abbreviations:
ARF: Area Resource File:
CMS: Centers for Medicare & Medicaid Services:
ESR: Dend-stage renal disease:
HHS: Department of Health and Human Services:
NIH: National Institutes of Health:
SCHIP: State Children's Health Insurance Program:
USRDS: United States Renal Data System:
United States Government Accountability Office:
Washington, DC 20548:
September 28, 2007:
The Honorable Max Baucus:
Chairman:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
The Honorable Christopher J. Dodd:
Chairman:
Subcommittee on Children and Families:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
Regardless of age, most individuals with end-stage renal disease
(ESRD), the permanent loss of kidney function, are covered under
Medicare.[Footnote 1] Individuals with ERSD must either receive kidney
transplants or undergo regular dialysis treatments,[Footnote 2] which
remove excess fluids and wastes from the blood, in order to survive.
Medicare covers kidney transplants and 36 months of follow-up care, and
for individuals who do not receive kidney transplants, Medicare covers
regular dialysis treatments.[Footnote 3] In the long term, dialysis is
associated with a lower quality of life and higher mortality rates than
kidney transplants and is considered a less desirable treatment option.
Kidney transplant recipients must take immunosuppressive
medications[Footnote 4] for the life of the transplant to avoid
transplant failure, and the cost of these medications is substantial--
ranging from $5,000 to $13,000 annually. Transplant recipients who stop
taking immunosuppressive medications (referred to as medication
noncompliance) and experience transplant failure must, absent a
retransplant, receive regular dialysis treatments in order to
survive.[Footnote 5] Transplant failures may be particularly
problematic for pediatric recipients[Footnote 6] because long-term
dialysis can lead to developmental problems, such as inhibited growth,
as well as poor academic performance and delayed social development.
Unless a transplant recipient is eligible for Medicare[Footnote 7]
other than because of ESRD, coverage of immunosuppressive medications,
along with follow-up care, ends 36 months posttransplant. Pediatric
transplant recipients may be more likely than their adult counterparts
to lose access to immunosuppressive medications once Medicare coverage
for ESRD ends because they may lack access to other health insurance
coverage. Access to health insurance may be particularly problematic
for those individuals who are 18 or older but were under 18 at the time
of their transplants--for the purposes of this report, we refer to
these individuals as transitional recipients. While some pediatric
recipients may be covered by their parents' health insurance, family
insurance coverage often does not extend to children over 18 unless
they are full-time students. While a lack of health insurance is one
reason transplant recipients may stop taking their medication, studies
have reported that there are numerous other reasons for medication
noncompliance, including avoidance of adverse side effects associated
with immunosuppressive medications and difficulty following complex
treatment regimens.
In light of these concerns, you asked us to describe certain aspects of
kidney transplant recipients, determine the extent to which they
experience transplant failure and subsequent outcomes, and calculate
the cost associated with their treatment. In this report, we (1)
compare certain demographic characteristics and types of health
insurance coverage of pediatric, transitional, and adult kidney
transplant recipients; (2) examine the percentage of transplant
failures and subsequent outcomes--retransplant, dialysis, or death--
among pediatric, transitional, and adult kidney transplant recipients;
(3) determine how the percentage of transplant failures and subsequent
outcomes of kidney transplant recipients compare by type of health
insurance coverage; and (4) examine how the cost to Medicare for a
beneficiary with a functioning transplant compares with the cost for a
beneficiary with a transplant failure.
To determine the characteristics of pediatric, transitional, and adult
kidney transplant recipients,[Footnote 8] we used 2004 data--the latest
data available--on recipient age, sex, race, and type of health
insurance coverage[Footnote 9] from the United States Renal Data System
(USRDS). The USRDS is a national data system maintained by the
Department of Health and Human Services' (HHS) National Institutes of
Health (NIH) that contains data on individuals with ESRD collected from
many sources, including HHS's Centers for Medicare & Medicaid Services
(CMS), the agency that administers Medicare, and the United Network for
Organ Sharing. We used USRDS to define three age groups: pediatric
recipients are those who were younger than 18 years old as of December
31, 2004, transitional recipients are those who were younger than 18
years old at the time of their transplants and at least 18 years old as
of December 31, 2004, and adult recipients are those who were at least
18 years old at the time of their transplants. We used USRDS data to
compare the distribution of sex, race, and income levels among
pediatric, transitional, and adult recipients who had a functioning
transplant as of December 31, 2004. There were 3,675 pediatric
recipients, 4,608 transitional recipients, and 110,762 adult recipients
in the USRDS data who met this criterion. We also compared the
demographic characteristics of the three age groups to those found in
the general U.S. population, using data from the 2000 U.S. Census. To
estimate the income levels for recipients in each of our three age
groups, we matched recipients' zip codes and federal information
processing standards codes using the 2002 median household income for
the county[Footnote 10] of their residence as published in the 2005
Area Resource File (ARF), the latest data available.[Footnote 11] The
USRDS maintains health insurance information under three categories:
Medicare but not Medicaid, Medicare and Medicaid, and Other. The Other
category is defined as those who do not have Medicare coverage but are
covered by private health insurance, Medicaid, or other governmental
health insurance or are uninsured or whose health insurance status is
unknown. Our analysis is based on recipients who had a functioning
kidney-only transplant as of December 31, 2004.[Footnote 12]
To examine the percentage of transplant failures and subsequent
outcomes among pediatric, transitional, and adult kidney transplant
recipients, we used data through December 31, 2004, from the USRDS on
individuals who received kidney-only transplants from 1997 through
2000.[Footnote 13] There were 1,218 pediatric recipients, 2,148
transitional recipients, and 49,940 adult recipients who met this
criterion. We analyzed data separately for pediatric, transitional, and
adult recipients. We determined the frequency of transplant failures
among each of the three age groups at 1 year, 3 years, 5 years, and 7
years after the transplant using the date of failure reported in the
USRDS, and we grouped the frequencies by age group and these follow-up
periods.[Footnote 14] For recipients whose transplants failed, we
determined the percentage who died,[Footnote 15] received
retransplants, or received dialysis during the follow-up periods, by
age group. These outcome groups are not mutually exclusive; for
example, if an individual received both dialysis and a subsequent
retransplant, the individual is counted in both groups. A recipient who
died after a transplant failure could have received dialysis or a
retransplant between date of failure and date of death. Those
recipients who had dates of failure but no subsequent treatment
information or dates of death were excluded from our analysis. We
included only transplant recipients in the 50 states and the District
of Columbia.
To compare the percentage of transplant failures and subsequent
outcomes of kidney transplant recipients by type of health insurance
coverage, we used data through December 31, 2004, from the USRDS on
individuals who received kidney-only transplants from 1997 through
2000.[Footnote 16] The USRDS maintains health insurance information
under three categories: Medicare but not Medicaid, Medicare and
Medicaid, and Other. There were 33,702 recipients with Medicare but not
Medicaid, 12,139 recipients with Medicare and Medicaid, and 7,465
recipients in the Other category who met this criterion. Using the same
three categories, we determined the frequency of transplant failures by
type of health insurance coverage at 1 year, 3 years, 5 years, and 7
years after the transplant and we grouped the frequencies by the follow-
up periods.[Footnote 17] For recipients whose transplants failed, we
determined the percentage who died,[Footnote 18] received
retransplants, or received dialysis during the follow-up periods. As
described above, these outcome groups are not mutually exclusive.
To examine how the cost to Medicare for a beneficiary with a
functioning transplant compares with the cost for a beneficiary with a
transplant failure, we used data through December 31, 2004, from the
USRDS on individuals who received kidney-only transplants from 1997
through 2000 and for whom Medicare reported costs.[Footnote 19] There
were 669 pediatric beneficiaries, 1,264 transitional beneficiaries, and
33,557 adult beneficiaries who met this criterion. For beneficiaries
with functioning transplants, we summed the Medicare costs from their
posttransplant hospital discharge dates through December 31, 2004. For
beneficiaries whose transplants failed and who subsequently died, we
summed the Medicare costs from their transplant failure dates through
the dates of death and annualized any portion incurred during a period
that was less than a full year. For beneficiaries whose transplants
failed but who did not die, we summed the Medicare costs from their
transplant failure dates through December 31, 2004.[Footnote 20] For
beneficiaries with functioning transplants and for those whose
transplants failed, we calculated the median annual cost per
beneficiary in each age group. For each of the four objectives, we
included only transplant recipients in the 50 states and the District
of Columbia. We reviewed relevant documentation and spoke with
knowledgeable officials to determine the reliability of the USRDS and
ARF. Based on this, we found the USRDS and ARF suitable for our
purposes.
We conducted a literature search of reported studies related to ESRD
and pediatric, transitional, and adult kidney transplant recipients and
conducted interviews with officials from CMS; the Health Resources and
Services Administration, a federal agency focused on access to health
care services; and NIH, the primary federal agency that conducts and
supports medical research and maintains the USRDS. We also interviewed
representatives of the National Kidney Foundation, the Forum of ESRD
Networks, and the American Society of Pediatric Nephrology. Of the 251
pediatric transplant centers in the United States, we interviewed
representatives from 6 centers that treat a high number of pediatric
recipients. Those 6 centers accounted for about 10 percent of the
13,560 pediatric kidney transplants performed since 1988.[Footnote 21]
We performed our work from October 2006 through August 2007 in
accordance with generally accepted government auditing standards.
Results in Brief:
Pediatric, transitional, and adult transplant recipients were similar
with respect to demographic characteristics such as sex, race, and
income level but differed in their types of health insurance coverage.
As of December 31, 2004, recipients in all three age groups were
predominately male, white, and lived in counties with a median annual
household income of $25,000 to less than $50,000. Unlike the
demographic characteristics, recipients' type of health insurance
coverage varied by age group. While more than two-thirds of adult
recipients had health insurance coverage under Medicare, just over one-
third of pediatric recipients and less than half of transitional
recipients were covered under Medicare. At the time of their
transplants, the percentage of recipients covered by Medicare was
higher for all age groups, although the percentages of pediatric (67
percent) and transitional (81 percent) recipients with Medicare
coverage were still lower than adult recipients (87 percent). It is not
known why these differences in Medicare coverage existed, given that
most individuals who have ESRD are eligible for Medicare coverage.
After the first year posttransplant, a higher percentage of
transitional recipients experienced a transplant failure and
subsequently received dialysis compared with their pediatric and adult
counterparts. For example, by 5 years posttransplant, the percentage of
transitional recipients who experienced a transplant failure (33
percent) was about twice as high as pediatric recipients (16 percent)
and somewhat higher than adult recipients (28 percent). The largest
increase in transplant failures for each age group occurred during the
first 3 years posttransplant--before the termination of Medicare
coverage on the basis of ESRD--and the increase was substantially
higher for transitional recipients (133 percent) than for pediatric (83
percent) and adult (100 percent) recipients. Compared to adult and
pediatric recipients, a higher percentage of transitional recipients
received dialysis after experiencing a transplant failure. A higher
percentage of pediatric recipients received retransplants after the
first year posttransplant, compared with adult and transitional
recipients, and a higher percentage of adult recipients died after
experiencing a transplant failure.
Recipients who had both Medicare and Medicaid coverage experienced a
higher percentage of transplant failures than those who had Medicare
but not Medicaid coverage or were in the Other category. For example,
by 7 years posttransplant, the percentage of recipients covered by both
Medicare and Medicaid who experienced a transplant failure (56 percent)
was more than three times as high as the percentage of recipients in
the Other category (16 percent). In addition, after experiencing a
transplant failure, a higher percentage of recipients who had both
Medicare and Medicaid coverage received dialysis when compared with
recipients who had Medicare but not Medicaid coverage or were in the
Other category. Throughout the 7 years of posttransplant follow-up, the
percentage of recipients covered by both Medicare and Medicaid who
received dialysis was substantially higher than the percentage for
recipients in the Other category.
Medicare beneficiaries with functioning transplants cost substantially
less per year to treat than those beneficiaries who experienced
transplant failures. Specifically, we found that the median annual
Medicare cost for a beneficiary whose transplant failed ($50,938) was
500 percent more than the median annual Medicare cost for a beneficiary
with a functioning transplant ($8,550).
The substantial cost of treating transplant recipients who experience
transplant failures underscores the importance of maintaining
functioning kidney transplants. While there are many reasons that could
account for transplant failures during the first 3 years
posttransplant--including medication noncompliance--the large
percentage increase in transplant failures from 1 year to 3 years
posttransplant for transitional recipients cannot be attributed to an
inability to access immunosuppressive medications due to a lack of
Medicare coverage.
In commenting on a draft of this report, CMS stated that it appreciated
our interest in kidney transplant patients and in the cost of care
provided to those receiving transplants or dialysis. CMS stated that it
was concerned about the quality of care and the outcomes experienced by
Medicare beneficiaries, including the higher rate of transplant failure
among transitional patients. CMS also pointed out that it engages in
numerous educational and outreach efforts targeted to beneficiaries,
providers, and national organizations that represent renal patients.
Background:
ESRD occurs when an individual's kidneys have regressed to less than 10
percent of normal baseline function. Without functioning kidneys,
excess wastes and fluids in the body rise to dangerous levels, and
certain hormones are no longer produced. Individuals with ESRD must
undergo either regular dialysis treatments or receive kidney
transplants to survive. As of the end of 2004, of the approximately
480,000 adults with ESRD (those at least 18 years old), just over one-
fourth (about 130,000) had functioning kidney transplants and two-
thirds (about 330,000) were receiving dialysis treatments.[Footnote 22]
In addition, of the almost 5,700 pediatric individuals with ESRD (those
younger than 18 years old), approximately two-thirds (about 3,800) had
functioning transplants and less than one-third (about 1,700) were
receiving dialysis treatments.[Footnote 23]
A kidney transplant is the preferred method of treatment for
individuals with ESRD because it increases an individual's quality of
life and decreases long-term mortality rates compared with lifetime
dialysis treatments. Studies have reported that pediatric ESRD patients
tend to perform better developmentally with transplants than on
dialysis. For example, one study reported improvement in neurological
development in infants aged 6-11 months following
transplantation.[Footnote 24] Another study showed that transplantation
increased the rate at which pediatric ESRD patients improved on
measures of intelligence and mathematical skills.[Footnote 25]
Medicare Coverage for Individuals with ESRD:
Medicare covers over 80 percent of all individuals with ESRD. For these
individuals, Medicare covers the cost of lifetime dialysis treatments,
or for individuals who receive kidney transplants, the cost of the
transplants and 3 years of follow-up care--including immunosuppressive
medications needed to sustain the transplants. Medicare also covers
hospital inpatient services and outpatient services, such as physician
visits and laboratory tests, as well as medical evaluations provided to
living donors and recipients in anticipation of transplants. In
addition to Medicare, individuals with ESRD may be covered by other
public or private health insurance, such as Medicaid or an employer-
sponsored health plan. For individuals who are eligible for Medicare on
the basis of ESRD, Medicare is the secondary payer if the individuals
have employer-sponsored group health insurance coverage during the
first 30 months of Medicare coverage. After the first 30 months,
Medicare becomes the primary payer for these beneficiaries until they
are no longer entitled to Medicare. For an individual who is eligible
for Medicare solely because of ESRD and who has a kidney transplant,
Medicare coverage ends on the last day of the 36th month after the
individual receives the transplant unless the individual is entitled to
Medicare other than because of ESRD.[Footnote 26] However, after 36
months, a transplant recipient can become eligible for Medicare again
after a transplant failure and subsequently receive a retransplant or
dialysis.
Following termination of Medicare coverage, individuals who are unable
to pay for immunosuppressive medications and other transplant-related
follow-up care must rely on other public or private health insurance or
charity care. Pediatric recipients have several potential sources of
coverage when their Medicare coverage ends: private health insurance--
generally, a parent's employer-sponsored coverage;[Footnote 27]
Medicaid;[Footnote 28] the State Children's Health Insurance Program
(SCHIP);[Footnote 29] and charity care. However, once individuals turn
19, they may lose access to their parents' private insurance coverage
as well as coverage under SCHIP and Medicaid.
Posttransplant Immunosuppressive Therapy:
Individuals who receive kidney transplants require immunosuppressive
therapy--usually a combination of at least two different
immunosuppressive medications--as well as regular laboratory tests to
monitor and maintain their transplants. Although the frequency of
laboratory tests decreases over time, the need for immunosuppressive
medications continues for the life of the transplant.
Recipients who do not take their immunosuppressive medications
according to the prescribed regimens are more likely to have their
transplanted kidneys fail. Studies have shown that not only does
medication noncompliance cause 13 to 35 percent of transplants to fail,
one of the studies indicated that it also causes recipients to die at
rates fourfold greater than compliant recipients.[Footnote 30] One
recent study showed that about 23 percent of recipients with failed
transplants who returned to dialysis died within 2 years.[Footnote 31]
Several studies have reported that there are a number of reasons why
some transplant recipients do not comply with their medication
regimens. More specifically, one study reported that adverse side
effects of the medications,[Footnote 32] difficulty following complex
treatment regimens that involve several drugs and varying schedules of
dosing, and an inability to pay for medications due to a lack of health
insurance coverage, among other reasons, can contribute to medication
noncompliance.[Footnote 33] Other studies have reported that medication
noncompliance can be unpredictable, often without an identifiable
reason.[Footnote 34]
Studies have also shown that adolescent recipients are especially prone
to medication noncompliance or partial compliance. For example, one
study showed that for individuals aged 12 to 19 years, dissatisfaction
with body image and the physical side effects of medications have been
linked to poor compliance with prescribed transplant medication
regimens.[Footnote 35] Another study found that 57 percent of
participating recipients under 20 years old were not compliant with
their medication regimens, compared with only 15 percent of
participants over 40 years old.[Footnote 36]
Transplant Recipients in All Age Groups Had Similar Demographic
Characteristics, but Fewer Pediatric and Transitional Recipients Had
Medicare Coverage:
Pediatric, transitional, and adult kidney transplant recipients were
similar with respect to sex, race, and income level. As of December 31,
2004, all three age groups were predominately male, white, and lived in
counties with a median annual household income of $25,000 to less than
$50,000. However, the three groups differed in terms of their types of
health insurance coverage, with a smaller percentage of pediatric and
transitional recipients covered by Medicare compared to their adult
counterparts.
Pediatric, Transitional, and Adult Transplant Recipients Were Similar
with Respect to Sex, Race, and Income Level:
Based on our analyses of USRDS and ARF data, we found that pediatric,
transitional, and adult recipients were similar with respect to sex,
race, and income level, as of December 31, 2004. All three age groups
were predominantly male, and the proportion of males in each age group
was higher than that found in the general U.S. population--49 percent
(see table 1). Approximately 59 percent of individuals with ESRD are
male.
Table 1: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Sex:
Sex: Male;
Percentage of pediatric recipients: 62;
Percentage of transitional recipients: 57;
Percentage of adult recipients: 59.
Sex: Female;
Percentage of pediatric recipients: 39;
Percentage of transitional recipients: 43;
Percentage of adult recipients: 41.
Source: GAO analysis of USRDS data.
Note: Our analysis is based on kidney transplant recipients who had
functioning transplants as of December 31, 2004. The percentages may
not total 100 because of rounding.
[End of table]
All three age groups were also predominantly white, and the percentage
distribution of other races among the three groups was similar (see
table 2). Although a higher percentage of transitional recipients were
white and a lower percentage were black compared with pediatric and
adult recipients, the differences were not substantial. In addition,
the distribution of racial groups among pediatric, transitional, and
adult transplant recipients was similar to that found in the general
U.S. population.
Table 2: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Race:
Race: White;
Percentage of pediatric recipients: 77;
Percentage of transitional recipients: 82;
Percentage of adult recipients: 74.
Race: Black;
Percentage of pediatric recipients: 16;
Percentage of transitional recipients: 12;
Percentage of adult recipients: 19.
Race: Asian;
Percentage of pediatric recipients: 3;
Percentage of transitional recipients: 3;
Percentage of adult recipients: 5.
Race: Native American;
Percentage of pediatric recipients: 1;
Percentage of transitional recipients: 1;
Percentage of adult recipients: 1.
Race: Other;
Percentage of pediatric recipients: 2;
Percentage of transitional recipients: 1;
Percentage of adult recipients: 1.
Race: Not available;
Percentage of pediatric recipients: 1;
Percentage of transitional recipients: 0;
Percentage of adult recipients: 0.
Source: GAO analysis of USRDS data.
Note: Our analysis is based on kidney transplant recipients who had
functioning transplants as of December 31, 2004. The percentages may
not total 100 because of rounding.
[End of table]
Pediatric, transitional, and adult transplant recipients were similar
in terms of their household income level (see table 3). Seventy-five
percent of recipients in each age group resided in counties with a
median annual household income of $25,000 to less than $50,000, which
is almost three times the percentage for the general U.S. population
(27 percent). When compared to the general U.S. population, a very
small percentage of recipients in each of the three age groups resided
in counties with the lowest and highest median annual household
incomes--less than $25,000 or $75,000 or more, respectively. About 27
percent of the U.S. population resided in counties with a median annual
household income of less than $25,000 and about 28 percent resided in
counties with a median annual household income of $75,000 or more.
Table 3: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Median Annual County-Level Household Income:
Median annual county-level household income: Less than $10,000;
Percentage of pediatric recipients: 0;
Percentage of transitional recipients: 0;
Percentage of adult recipients: 0.
Median annual county-level household income: $10,000 to less than
$25,000;
Percentage of pediatric recipients: 2;
Percentage of transitional recipients: 2;
Percentage of adult recipients: 1.
Median annual county-level household income: $25,000 to less than
$50,000;
Percentage of pediatric recipients: 75;
Percentage of transitional recipients: 75;
Percentage of adult recipients: 75.
Median annual county-level household income: $50,000 to less than
$75,000;
Percentage of pediatric recipients: 18;
Percentage of transitional recipients: 20;
Percentage of adult recipients: 21.
Median annual county-level household income: $75,000 or more;
Percentage of pediatric recipients: 1;
Percentage of transitional recipients: 1;
Percentage of adult recipients: 1.
Median annual county-level household income: Not available;
Percentage of pediatric recipients: 5;
Percentage of transitional recipients: 3;
Percentage of adult recipients: 1.
Source: GAO analysis of USRDS data and the 2005 ARF of 2002 median
annual county-level household income.
Note: Our analysis is based on kidney transplant recipients who had
functioning transplants as of December 31, 2004. The percentages may
not total 100 because of rounding.
[End of table]
A Smaller Percentage of Pediatric and Transitional Recipients Had
Medicare Coverage:
While pediatric, transitional, and adult transplant recipients were
similar in terms of sex, race, and income, they were less similar in
terms of their health insurance coverage. As of December 31, 2004,
while more than two-thirds of adult recipients had coverage under
Medicare, just over one-third of pediatric recipients and slightly less
than half of transitional recipients were covered under Medicare (see
table 4). Although each group had about the same percentage of
recipients with both Medicare and Medicaid coverage, almost three times
as many adult recipients had Medicare but not Medicaid coverage
compared with pediatric recipients, and almost twice as many adult
recipients had Medicare but not Medicaid coverage compared with
transitional recipients.
Table 4: Distribution of Pediatric, Transitional, and Adult Kidney
Transplant Recipients by Insurance Coverage:
Insurance coverage: Medicare but not Medicaid;
Percentage of pediatric recipients: 20;
Percentage of transitional recipients: 30;
Percentage of adult recipients: 55.
Insurance coverage: Medicare and Medicaid;
Percentage of pediatric recipients: 15;
Percentage of transitional recipients: 17;
Percentage of adult recipients: 15.
Insurance coverage: Other[A];
Percentage of pediatric recipients: 65;
Percentage of transitional recipients: 53;
Percentage of adult recipients: 30.
Source: GAO analysis of USRDS data.
Note: Our analysis is based on the latest reported health insurance
coverage by kidney transplant recipients who had functioning
transplants as of December 31, 2004.
[A] Other is defined as those who do not have Medicare coverage but are
covered by private health insurance, Medicaid, or other governmental
health insurance or are uninsured or whose health insurance status is
unknown.
[End of table]
Although still smaller than the percentage of adult recipients, based
on our analysis of USRDS data, a larger percentage of pediatric and
transitional recipients had Medicare coverage at the time of their
transplants--67 percent and 81 percent, respectively, compared to 87
percent. It is not known why these differences in Medicare coverage
existed, given that most individuals who have ESRD are eligible for
Medicare coverage.
A Higher Percentage of Transitional Recipients Experienced Transplant
Failure and Received Dialysis:
Our analysis of data from the USRDS show that after the first year
posttransplant, a higher percentage of transitional recipients
experienced a transplant failure compared with their pediatric and
adult counterparts. In addition, the largest increase in transplant
failure among the three age groups occurred in the first 3 years
posttransplant--before termination of Medicare coverage--and the
increase was substantially higher for transitional recipients than for
pediatric and adult recipients. After experiencing a transplant
failure, a higher percentage of transitional recipients received
dialysis, a higher percentage of pediatric recipients received
retransplants after the first year posttransplant, and a higher
percentage of adult recipients died.
A Higher Percentage of Transitional Recipients Experienced Transplant
Failure Compared with Pediatric and Adult Recipients:
Based on our analysis of USRDS data, we found that after the first year
posttransplant, a higher percentage of transitional recipients
experienced a transplant failure when compared with their pediatric and
adult counterparts (see fig. 1). For example, we found that by 5 years
posttransplant, the percentage of transitional recipients who
experienced a transplant failure (33 percent) was about twice as high
as the percentage of pediatric recipients (16 percent) and somewhat
higher than adult recipients (28 percent). According to several
representatives of pediatric kidney transplant centers that we
interviewed, adolescent kidney transplant recipients--who generally
populate our transitional age group--are less likely than other age
groups to comply with their medication regimens, which, among other
things, can lead to transplant failure.
Figure 1: Percentage of Kidney Transplant Recipients Whose Transplants
Failed, by Age Group and Number of Years Posttransplant:
This figure is a bar chart showing percentages of kidney transplant
recipients whose transplants failed, by age group and number of years
posttransplant, between 1997 and 2004. 6% of pediatric recipients, 9%
of transitional recipient, and 9% of adult recipients had failed
transplants in the first year. 11% of pediatric recipients, 21% of
transitional recipients, and 18% of adult recipients had failed
transplants after three years. 16% of pediatric recipients, 33 percent
of transitional recipients, and 28% of recipients had transplants fail
after five years. 26% of pediatric recipients, 44% of transitional
recipients, and 40% of adult recipients had transplants fail after 7
years.
[See PDF for image]
Source: GAO analysis of USRDS data.
Notes: Our analysis is based on individuals who received kidney
transplants from 1997 through 2000. The percentage of kidney transplant
failures is equal to the number of recipients whose transplants failed
in that time period divided by the total number who received
transplants during the same time period.
[End of figure]
The largest increase in the percentage of transitional recipients who
experienced a transplant failure occurred in the first 3 years
posttransplant, and this increase was substantially higher than the
increase for pediatric and adult recipients. Specifically, the
percentage of failures for transitional recipients increased by 133
percent between 1 and 3 years posttransplant, while the percentage
increases for pediatric and adult recipients were 83 and 100 percent,
respectively.
After 3 years posttransplant, all three age groups showed a smaller
increase in transplant failures when compared with the period between 1
and 3 years posttransplant. Between 3 and 5 years posttransplant, the
percentage increase in transplant failures was 45 percent for
pediatric, 57 percent for transitional, and 56 percent for adult
recipients. The percentage increase in failures remained lower during
the 5 to 7 years posttransplant period--63 percent, 33 percent, and 43
percent for pediatric, transitional, and adult recipients,
respectively. Failure to see a large percentage increase of transplant
failures in pediatric and transitional recipients beyond 3 years
posttransplant, when Medicare coverage terminates for many recipients,
may be explained by the practices of transplant centers.
Representatives from pediatric kidney transplant centers with whom we
spoke stated that once Medicare coverage ends, they either help
recipients to acquire other health insurance coverage or provide them
with free or reduced-cost immunosuppressive medications if they lack
health insurance coverage or otherwise cannot afford the medications.
They also stated that the percentage of recipients who experience
transplant failures because of an inability to pay for their
medications after Medicare coverage ends (3 years posttransplant) is
low.
A Higher Percentage of Transitional Recipients Received Dialysis
Compared with Pediatric and Adult Recipients:
Based on our analysis of USRDS data, we found that after experiencing
transplant failures, a higher percentage of transitional recipients
received dialysis, a higher percentage of pediatric recipients received
retransplants after the first year posttransplant, and a higher
percentage of adult recipients died (see figs. 2, 3, and 4).[Footnote
37] By 7 years posttransplant, the percentage of transitional
recipients who received dialysis after experiencing a transplant
failure was nearly 30 percent higher than that of pediatric recipients
and nearly 60 percent higher than that of adult recipients. In
addition, at 7 years posttransplant, the percentage of pediatric
recipients who received retransplants after experiencing a transplant
failure was over 25 percent higher than that of transitional recipients
and more than twice the percentage of adults who received
retransplants. The percentage of adults who died following a transplant
failure was about twice as high as the percentage of pediatric
recipients and about three times as high as transitional recipients.
Figure 2: Percentage of Kidney Transplant Recipients Who Received
Dialysis after Transplant Failure, by Age Group and Number of Years
Posttransplant:
This is a bar chart showing percentage of kidney transplant recipients
who received dialysis after transplant failure, by age group and number
of years posttransplant. 42% of pediatric recipients, 52% of
transitional recipients, and 41% adult recipients received dialysis
after transplant failure in the first year. 52% of pediatric
recipients, 77% of transitional recipients, and 50% of adult recipients
received dialysis after transplant failure after three years. 62% of
pediatric recipients, 82% of transitional recipients, and 53% of adult
recipients received dialysis after transplant failure after five years.
64% of pediatric recipients, 82% of transitional recipients, and 52% of
adult recipients received dialysis after transplant failure after seven
years.
[See PDF for image]
Source: GAO analysis of USRDS data.
Notes: Our analysis is based on individuals who received kidney
transplants from 1997 through 2000. The percentage of kidney transplant
recipients who received dialysis is equal to the number of transplant
recipients on dialysis in that time period divided by the total number
of recipients whose transplants failed during the same time period.
[End of figure]
Figure 3: Percentage of Kidney Transplant Recipients Who Received
Retransplants after Transplant Failure, by Age Group and Number of
Years Posttransplant:
This figure is a bar chart showing the percentage of kidney transplant
recipients who received retransplants after transplant failure, by age
group and number of years posttransplant. 1% of pediatric recipients,
2% of transitional recipients, and 0% of adult recipients received
retransplants one year after transplant failure. 9% of pediatric
recipients, 6% of transitional recipients, and 3% percent of adult
recipients received retransplants three years after transplant failure.
16% of pediatric recipients, 14% of transitional recipients, and 8%
percent of adult recipients received retransplants five years after
transplant failure. 24% of pediatric recipients, 19% of transitional
recipients, and 11% percent of adult recipients received retransplants
seven years after transplant failure.
[See PDF for image]
Notes: Our analysis is based on individuals who received kidney
transplants from 1997 through 2000. The percentage of kidney transplant
recipients who received retransplants is equal to the number of
transplant recipients who received retransplants in that time period
divided by the total number of recipients whose transplants failed
during the same time period.
[End of figure]
Figure 4: Percentage of Kidney Transplant Recipients Who Died after
Transplant Failure, by Age Group and Number of Years Posttransplant:
This is a figure showing percentage of kidney transplant recipients who
died after transplant failure, by age group and number of years
posttransplant. 31% of pediatric recipients, 19% of transitional
recipients, and 53% of adult recipients died one year after transplant
failure. 33% of pediatric recipients, 17% of transitional recipients,
and 55% of adult recipients died thee years after transplant failure.
32% of pediatric recipients, 19% of transitional recipients, and 58% of
adult recipients died five years after transplant failure. 31% of
pediatric recipients, 25% of transitional recipients, and 62% of adult
recipients died seven years after transplant failure.
[See PDF for image]
Source: GAO analysis of USRDS data.
Notes: Our analysis is based on individuals who received kidney
transplants from 1997 through 2000. The percentage of kidney transplant
recipients who died is equal to the number of recipients who died in
that time period divided by the total number of recipients whose
transplants failed during the same time period.
[End of figure]
A Higher Percentage of Recipients with Both Medicare and Medicaid
Coverage Experienced Transplant Failure and Received Dialysis:
Based on our analysis of USRDS data, we found that recipients who had
both Medicare and Medicaid coverage experienced a higher percentage of
transplant failures compared with those who had Medicare but not
Medicaid coverage or were in the Other category (see fig. 5). By 7
years posttransplant, the percentage of recipients covered by both
Medicare and Medicaid who experienced a transplant failure was slightly
higher (24 percent) than recipients covered by Medicare but not
Medicaid and was more than three times as high as the percentage of
recipients in the Other category.
Figure 5: Percentage of Kidney Transplant Recipients Whose Transplants
Failed, by Type of Health Insurance Coverage and Number of Years
Posttransplant:
This is a bar chart showing the percentage of kidney transplant
recipients whose transplants failed, by type of health insurance
coverage and number of years posttransplant. 9% of Medicare, not
Medicaid recipients failed, 11% of medicare and medicaid recipients
failed, and 7% of other[A] failed within the first year. 18% of
Medicare, not Medicaid recipients failed, 24% of medicare and medicaid
recipients failed, and 13% of other[A] failed after three years. 32% of
Medicare, not Medicaid recipients failed, 43% of medicare and medicaid
recipients failed, and 11% of other[A] failed after five years. 45% of
Medicare, not Medicaid recipients failed, 564% of medicare and medicaid
recipients failed, and 16% of other[A] failed after seven years.
[See PDF for image]
Source: GAO analysis of USRDS data.
Notes: Our analysis is based on individuals who received kidney
transplants from 1997 through 2000. The percentage of kidney transplant
failures is equal to the number of recipients whose transplants failed
in that time period divided by the total number who received
transplants during the same time period.
[A] Other is defined as those who do not have Medicare coverage but are
covered by private health insurance, Medicaid, or other governmental
health insurance or are uninsured or whose health insurance status is
unknown.
[End of figure]
After experiencing a transplant failure, a higher percentage of
recipients who had both Medicare and Medicaid coverage received
dialysis when compared with recipients who had Medicare but not
Medicaid coverage or were in the Other category (see fig. 6). For
example, by 7 years posttransplant, the percentage of recipients
covered by both Medicare and Medicaid who received dialysis after
experiencing a transplant failure was about 70 percent higher than
recipients in the Other category. After the first year posttransplant,
the percentage of recipients covered by both Medicare and Medicaid who
received dialysis after a transplant failure was substantially higher
than the percentage for recipients in the Other category.
Figure 6: Percentage of Kidney Transplant Recipients Who Received
Dialysis after Transplant Failure, by Type of Health Insurance Coverage
and Number of Years Posttransplant:
This figure is a bar chart showing percentage of kidney transplant
recipients who received dialysis after transplant failure, by type of
health insurance coverage and number of years post transplant. 40% of
medicare, not medicaid recipients received dialysis after transplant
failure, 57% of medicare and medicaid recipients received dialysis
after transplant failure, and 5% of other[A] recipients received
dialysis after the first year. 48% of medicare, not medicaid recipients
received dialysis after transplant failure, 63% of medicare and
medicaid recipients received dialysis after transplant failure, and 29%
of other[A] recipients received dialysis after three years. 52% of
medicare, not medicaid recipients received dialysis after transplant
failure, 66% of medicare and medicaid recipients received dialysis
after transplant failure, and 39% of other[A] recipients received
dialysis after five years. 51% of medicare, not medicaid recipients
received dialysis after transplant failure, 64% of medicare and
medicaid recipients received dialysis after transplant failure, and 37%
of other[A] recipients received dialysis after seven years.
[See PDF for image]
Notes: Our analysis is based on those who received kidney transplants
from 1997 through 2000. The percentage of kidney transplant recipients
who received dialysis is equal to the number of transplant recipients
on dialysis in that time period divided by the total number of
recipients whose transplants failed during the same time period.
[A] Other is defined as those who do not have Medicare coverage but are
covered by private health insurance, Medicaid, or other governmental
health insurance or are uninsured or whose health insurance status is
unknown.
[End of figure]
Beneficiaries with Functioning Transplants Were Substantially Less
Costly to Medicare Than Those with Transplant Failures:
Based on our analysis of USRDS data, we found that Medicare
beneficiaries with functioning transplants cost substantially less per
year to treat than those beneficiaries who experienced transplant
failures. Specifically, we found that overall, the median annual
Medicare cost for a beneficiary with a functioning transplant was
$8,550, compared with a median annual Medicare cost of $50,938 for a
beneficiary after a transplant failure--a difference of 500 percent.
For pediatric beneficiaries, the percentage difference was even higher-
-the median annual Medicare cost after a transplant failure was 750
percent higher than for a functioning transplant (see table 5). The
differences for transitional and adult beneficiaries were 550 percent
and 500 percent, respectively.[Footnote 38]
Table 5: Median Annual Medicare Cost per Beneficiary with a Functioning
Transplant and after a Transplant Failure, by Age Group:
Age group: All;
Median annual cost per beneficiary to maintain a functioning
transplant: $8,550;
Median annual cost per beneficiary after transplant failure: $50,938.
Age group: Pediatric;
Median annual cost per beneficiary to maintain a functioning
transplant: 4,916;
Median annual cost per beneficiary after transplant failure: 41,929.
Age group: Transitional;
Median annual cost per beneficiary to maintain a functioning
transplant: 6,714;
Median annual cost per beneficiary after transplant failure: 43,678.
Age group: Adult;
Median annual cost per beneficiary to maintain a functioning
transplant: 8,708;
Median annual cost per beneficiary after transplant failure: 51,755.
Source: GAO analysis of USRDS data.
Note: Our analysis is based on those who received kidney transplants
from 1997 through 2000.
[End of table]
Concluding Observations:
The substantial cost of treating transplant recipients who experience
transplant failures underscores the importance of maintaining
functioning kidney transplants. While there are many reasons that could
account for transplant failures during the first 3 years
posttransplant--including medication noncompliance--the large
percentage increase in transplant failures from 1 year to 3 years
posttransplant for transitional recipients cannot be attributed to an
inability to access immunosuppressive medications due to a lack of
Medicare coverage.
Agency Comments:
In commenting on a draft of this report, CMS stated that it appreciated
our interest in kidney transplant patients and in the cost of care
provided to those receiving transplants or dialysis. CMS stated that it
was concerned about the quality of care and the outcomes experienced by
Medicare beneficiaries, including the higher rate of transplant failure
among transitional patients. CMS also stated that educating
beneficiaries with kidney failure is critical to improving
beneficiaries' ability to actively participate in and make informed
decisions about their care. As a result, the agency engages in numerous
educational and outreach efforts targeted to beneficiaries, providers,
and national organizations that represent renal patients. CMS's
comments are reprinted in appendix I.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution of it until 30
days from the date of this letter. At that time, we will send copies of
this report to the Secretary of HHS and to other interested parties. In
addition, this report will be available at no charge on GAO's Web site
at [hyperlink, http://www.gao.gov]. We will also make copies available
to others upon request.
If you or your staff have any questions about this report, please call
me at (202) 512-7114 or ekstrandl@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix II.
Signed by:
Laurie E. Ekstrand:
Director, Health Care:
[End of section]
Appendix I: Comments from the Centers for Medicare & Medicaid Services:
Department Of Health & Human Services:
Centers For Medicare & Medicaid Services:
Office Of The Administrator:
Washington, DC 20201:
September 7, 2007:
To: Laurie E. Ekstrand:
Director, Health Care:
Government Accountability Office:
From and Signed by:
Kerry Weems:
Acting Administrator:
Subject: Government Accountability Office's (Gao) Draft Report: End-
Stage Renal Disease: Characteristics of Kidney Transplant Recipients,
Frequency of Transplant Failures, and Cost to Medicare (GAO-07-1117)
Thank you for the opportunity to review and comment on the above
referenced subject final report. We appreciate the GAO's interest in
transplant patients and the cost of care provided to those receiving a
transplant or dialysis. The Centers for Medicare & Medicaid Services
(CMS) is, as always, concerned about the quality of care and the
outcomes experienced by Medicare beneficiaries. Since transplant
failure affects the quality of life of patients as well as a return to
a significantly more costly treatment modality, the higher rate of
transplant failure in transitional patients is an important concern for
both patients and CMS. Consequently, CMS engages in numerous
educational and outreach activities targeted to beneficiaries, renal
providers, and a variety of national organizations that represent renal
patients and the renal community.
Education of all Medicare beneficiaries with kidney failure is critical
to their ability to actively participate in their care and make
informed healthcare decisions. Consequently, the ESRD Networks, who are
CMS contractors, distribute the New ESRD Patient Orientation Package to
all new Medicare enrollees with ESRD when they receive their Medicare
ESRD eligibility form. This orientation package includes the "Medicare
Coverage of Kidney Dialysis and Kidney Transplant Services" handbook,
which includes a transplant chapter with information on
immunosuppressive drugs, their use and the possible ramifications if a
kidney transplant patient stops taking their immunosuppressive
medicines as prescribed. This chapter also includes information on
Medicare prescription drug plan coverage for ESRD patients. In
addition, the package contains the guide, "You Can Live: Your Guide to
Living with Kidney Failure", which provides information on treatment
options for kidney failure including transplantation. Both of these
publications can also be found on [hyperlink,
http://www.medicare.gov/dialysis] under resources. The ESRD Networks
have also focused some of their efforts on transplantation by carrying
out follow-up transplant data collection, conducting transplant
education and promotion, as well as encouraging dialysis facilities to
conduct and follow through on patient assessments for transplantation.
In addition to these educational activities, both CMS and the ESRD
Networks have developed strong, active partnerships with the National
Kidney Foundation (NKF), the American Kidney Fund (AKF), and the
American Association of Kidney Patients (AAKP). All three of these
organizations are influential kidney patient advocates and provide
significant outreach to the renal community. For example, CMS partnered
with the NKF for a series of seven teleconferences specific to the
implementation of Medicare Part D. Participation for each of the seven
calls was high, with approximately 400 lines in use. Subsequent to the
calls, NKF has continued to convey information to their membership as
well as alert CMS to issues as they arise. On another occasion, CMS
partnered with NKF, AKF, AAKP, and 80 other individuals and
organizations to form the Kidney Community Emergency Response Coalition
in order to assure that all kidney patients in time of disaster or
emergency receive the care, treatment, drugs, and services that they
need to remain healthy. This coalition is in its second year and
remains active and committed to its original purpose.
Again, we appreciate GAO's interest in transplant patients and the cost
of care provided to those receiving a transplant or dialysis. We look
forward to working together to make improvements to the quality of care
and the outcomes experienced by Medicare beneficiaries.
[End of section]
Appendix II: GAO Contact and Staff Acknowledgments:
GAO Contact:
Laurie Ekstrand, (202) 512-7114 or ekstrandl@gao.gov:
Acknowledgments:
In addition to the contact named above, Nancy Edwards, Assistant
Director; Kelly DeMots; Krister Friday; Joanna Hiatt; Xiaoyi Huang;
Martha Kelly; and Ba Lin made key contributions to this report.
Footnotes:
[1] Generally, individuals with ESRD are eligible for benefits under
Medicare if they (1) are entitled to monthly insurance benefits under
Title II of the Social Security Act (or an annuity under the Railroad
Retirement Act of 1974), (2) meet certain work requirements under the
Social Security or Railroad Retirement programs, or (3) are the spouse
or dependent child of a person who meets at least one of the first two
requirements. 42 U.S.C. § 426-1 (2000). In addition to Medicare,
individuals with ESRD may also be covered by other public or private
health insurance, including Medicaid.
[2] Individuals with ESRD typically receive dialysis treatments three
times per week.
[3] For the first 30 months of an individual's Medicare coverage,
Medicare is the secondary payer for individuals with employer-sponsored
group health insurance coverage.
[4] Immunosuppressive medications diminish an individual's natural
immune response to the presence of foreign objects so that the body
does not reject the newly transplanted kidney.
[5] Medicare covers the cost of a retransplant and regular dialysis
treatments if kidney transplant recipients experience a transplant
failure.
[6] For the purposes of this report, we define pediatric transplant
recipients as those younger than 18 years old as of December 31, 2004.
[7] In general, Medicare coverage is available to individuals who are
65 years or older or are disabled and who qualify for benefits under
the Social Security Act or Railroad Retirement Act. 42 U.S.C. § 426
(2000).
[8] We did not have information on the health status of the transplant
recipients beyond the fact that they had ESRD.
[9] For the purposes of this objective, for each recipient, we
determined the type of health insurance coverage as of December 31,
2004, and as of the recipient's transplant date.
[10] Median annual household income estimates are county-level averages
and are not calculated from actual annual household incomes of
transplant recipients. Data on individual recipients' household income
levels are not available.
[11] The ARF is a database containing information on every county in
the United States. It is maintained by Quality Resource Systems, Inc.,
which is under contract with the National Center for Health Workforce
Analysis within HHS's Health Resources and Services Administration.
[12] We excluded those who received kidney-pancreas transplants.
According to data from the Organ Procurement and Transplant Network,
kidney-pancreas transplants represent less than 5.7 percent of all
kidney transplants performed since 1988.
[13] We included individuals who received initial kidney transplants as
well as those who received retransplants from 1997 through 2000. We did
not have information on the health status of the transplant recipients
beyond the fact that they had ESRD.
[14] For those who received transplants in 1997, we report at 1 year, 3
years, 5 years, and 7 years after the transplant. For those who
received transplants in 1998 and 1999, we report at 1 year, 3 years,
and 5 years after the transplant. For those who received transplants in
2000, we report at 1 year and 3 years after the transplant.
[15] These recipients could have died for causes other than transplant
failure because USRDS also categorizes death with a functioning
transplant as a transplant failure.
[16] We included individuals who received initial kidney transplants as
well as those who received retransplants from 1997 through 2000. We did
not have information on the health status of the transplant recipients
beyond the fact that they had ESRD.
[17] For those who received transplants in 1997, we report at 1 year, 3
years, 5 years, and 7 years after the transplant. For those who
received transplants in 1998 and 1999, we report at 1 year, 3 years,
and 5 years after the transplant. For those who received transplants in
2000, we report at 1 year and 3 years after the transplant.
[18] These recipients could have died from causes other than transplant
failure because USRDS also categorizes death with a functioning
transplant as a transplant failure.
[19] We included individuals who received initial kidney transplants as
well as those who received retransplants from 1997 through 2000. We did
not have information on the health status of the transplant recipients
beyond the fact that they had ESRD.
[20] If USRDS did not report Medicare cost data on a beneficiary
through December 31, 2004, we summed cost data from hospital discharge
date following the transplant to the latest date with available cost
data.
[21] We interviewed representatives from transplant centers in
California, Texas, Pennsylvania, Illinois, and Florida.
[22] The remaining approximately 20,000 adults with ESRD were lost to
follow-up.
[23] The remaining approximately 200 pediatric individuals with ESRD
were lost to follow-up.
[24] M.S. Polinsky et al., "Neurologic Development of Children with
Severe Chronic Renal Failure from Infancy," Pediatric Nephrology, vol.
1 (1987), 157-165 (citing endnote 6).
[25] R.S. Fennell III et al., "Effects of Kidney Transplantation on
Cognitive Performance in a Pediatric Population," Pediatrics, vol. 74
(1984), 273-278.
[26] For beneficiaries with ESRD who are also eligible for Medicare due
to age or disability, Medicare covers the immunosuppressive medications
for the life of the individual.
[27] Some private health insurance plans provide coverage for
dependants until age 23 if the dependant is a full-time student.
[28] Medicaid provides health care coverage to eligible low-income
people and is jointly financed by the federal government and the
states.
[29] SCHIP provides health care coverage to uninsured children in
families whose incomes exceed the eligibility requirements of Medicaid.
SCHIP has a capped allotment to states. States have some flexibility in
how they design their programs.
[30] E. F. Yen et al., "Cost-Effectiveness of Extending Medicare
Coverage of Immunosuppressive Medications to the Life of a Kidney
Transplant," American Journal of Transplantation, vol. 4 (2004): 1703-
1708 (citing endnotes 4-7 (reported from 1989, 1990, 1992, and 1999)),
and S.D. Geest et al., "Incidence, Determinants, and Consequences of
Subclinical Noncompliance with Immunosuppressive Therapy in Renal
Transplant Recipients," Transplantation, vol. 59, no. 3 (1995): 340-347
(citing endnotes 18-19 (1992)).
[31] Yen et al., "Cost-Effectiveness of Extending Medicare Coverage of
Immunosuppressive Medications to the Life of a Kidney Transplant."
[32] Immunosuppressive medications can increase patients' risk of
developing infections and can cause weight gain, cataracts, diabetes,
high blood pressure, bone disease, and damage to the liver and kidney.
[33] M. A. Chisholm, "Issues of Adherence to Immunosuppressant Therapy
After Solid-Organ Transplantation," Drugs, vol. 62, no. 4 (2002): 567-
575.
[34] See, for example, R. T. Schweizer et al., "Noncompliance in Organ
Transplant Recipients," Transplantation, vol. 49, no. 2 (1990): 374-
377, and Chisholm, "Issues of Adherence to Immunosuppressant Therapy
After Solid-Organ Transplantation."
[35] M. E. Ferris et al., "Trends in Treatment and Outcomes of Survival
of Adolescents Initiating End-Stage Renal Disease Care in the United
States of America," Pediatric Nephrology, vol. 21 (2006): 1020-1026
(citing endnote 16).
[36] Schweizer et al., "Noncompliance in Organ Transplant Recipients."
[37] After experiencing a transplant failure, the outcome for an
individual can be dialysis, retransplant, or death.
[38] Although the percentage difference for pediatric and transitional
recipients was well above 500 percent, the overall percentage is
virtually the same as the adult percentage because adults account for
95 percent of all recipients.
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