End-Stage Renal Disease
CMS Should Monitor Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled Payment System Gao ID: GAO-10-295 March 31, 2010Medicare covers dialysis for most individuals with end-stage renal disease (ESRD). Beginning in January 2011, the Centers for Medicare & Medicaid Services (CMS) is required to use a single payment to pay for dialysis and related services, which include injectable ESRD drugs. Questions have been raised about this new payment system's effects on the access to and quality of dialysis care for certain groups of beneficiaries, such as those who receive above average doses of injectable ESRD drugs. GAO examined (1) Medicare expenditures for injectable ESRD drugs, by demographic characteristics; (2) factors likely to result in above average doses of these drugs; (3) CMS's approach for addressing beneficiary differences in the cost of dialysis care under the new payment system; and (4) CMS's plans to monitor the new payment system's effects. GAO analyzed 2007 data--the most recent available--on Medicare ESRD expenditures and input from 73 nephrology clinicians and researchers collected using a Web-based data collection instrument. GAO also reviewed reports and CMS's proposed rule on the payment system's design and interviewed CMS officials.
Certain demographic groups had above average Medicare expenditures for injectable ESRD drugs in 2007. For example, Medicare spent $782 per month on injectable ESRD drugs per African American beneficiary, which was about 13 percent more than the average across all beneficiaries on dialysis and was also higher than for other racial groups. Similarly, monthly Medicare spending per beneficiary with additional coverage through Medicaid was about 6 percent higher than the average across all beneficiaries on dialysis. Although GAO did not identify the factors that led to the differences described above, it did obtain information from 73 nephrology clinicians and researchers, selected through referrals from dialysis-related professional organizations and a literature review, on the factors that they consider likely to result in above average doses of injectable ESRD drugs. A majority of these experts identified primarily clinical factors as likely to result in above average doses of these drugs. For example, at least 50 percent of the 73 clinicians and researchers from whom GAO obtained information identified 14 factors (including chronic blood loss and low iron stores) as likely to result in above average doses of erythropoiesis stimulating agents, which accounted for about 75 percent of expenditures on injectable ESRD drugs in 2007. CMS's proposed design for the new payment system for dialysis care includes, as required by law, two payment mechanisms to address differences across beneficiaries in their costs of dialysis care. Under the first payment mechanism--a case-mix adjustment--CMS proposed to adjust payments based on characteristics such as age, sex, and certain clinical conditions that are associated with beneficiaries' costs of dialysis care. The second proposed payment mechanism--an outlier policy--involves making additional payments to providers when they treat patients whose costs of care are substantially higher than would be expected. CMS's preliminary plans for monitoring the effects of the new payment system build on existing initiatives, but it is unclear whether CMS will monitor the effects on the quality of and access to dialysis care for groups of beneficiaries. In prior work, GAO and others have emphasized the importance of monitoring both the quality of and access to care to ensure that Medicare payment system changes do not result in certain groups of beneficiaries experiencing poor care quality or problems accessing services. CMS intends to monitor the quality of dialysis care under the new payment system, but the extent to which CMS will conduct such monitoring for various groups of beneficiaries is currently unclear because CMS's plans are preliminary. Furthermore, CMS's preliminary plans for monitoring access to dialysis care are limited. However, CMS has stated that it will have a comprehensive monitoring strategy in place by January 2011. GAO obtained comments on a draft of this report from CMS and from industry groups representing both large and small dialysis providers and nephrologists.
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: James C. Cosgrove Team: Government Accountability Office: Health Care Phone: (202) 512-7029GAO-10-295, End-Stage Renal Disease: CMS Should Monitor Access to and Quality of Dialysis Care Promptly after Implementation of New Bundled Payment System
This is the accessible text file for GAO report number GAO-10-295
entitled 'End-Stage Renal Disease: CMS Should Monitor Access to and
Quality of Dialysis Care Promptly after Implementation of New Bundled
Payment System' which was released on April 29, 2010.
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 Congressional Requesters:
United States Government Accountability Office:
GAO:
March 2010:
End-Stage Renal Disease:
CMS Should Monitor Access to and Quality of Dialysis Care Promptly
after Implementation of New Bundled Payment System:
End-Stage Renal Disease:
GAO-10-295:
GAO Highlights:
Highlights of GAO-10-295, a report to congressional requesters.
Why GAO Did This Study:
Medicare covers dialysis for most individuals with end-stage renal
disease (ESRD). Beginning in January 2011, the Centers for Medicare &
Medicaid Services (CMS) is required to use a single payment to pay for
dialysis and related services, which include injectable ESRD drugs.
Questions have been raised about this new payment system‘s effects on
the access to and quality of dialysis care for certain groups of
beneficiaries, such as those who receive above average doses of
injectable ESRD drugs. GAO examined (1) Medicare expenditures for
injectable ESRD drugs, by demographic characteristics; (2) factors
likely to result in above average doses of these drugs; (3) CMS‘s
approach for addressing beneficiary differences in the cost of
dialysis care under the new payment system; and (4) CMS‘s plans to
monitor the new payment system‘s effects. GAO analyzed 2007 data”the
most recent available”on Medicare ESRD expenditures and input from 73
nephrology clinicians and researchers collected using a Web-based data
collection instrument. GAO also reviewed reports and CMS‘s proposed
rule on the payment system‘s design and interviewed CMS officials.
What GAO Found:
Certain demographic groups had above average Medicare expenditures for
injectable ESRD drugs in 2007. For example, Medicare spent $782 per
month on injectable ESRD drugs per African American beneficiary, which
was about 13 percent more than the average across all beneficiaries on
dialysis and was also higher than for other racial groups. Similarly,
monthly Medicare spending per beneficiary with additional coverage
through Medicaid was about 6 percent higher than the average across
all beneficiaries on dialysis.
Although GAO did not identify the factors that led to the differences
described above, it did obtain information from 73 nephrology
clinicians and researchers, selected through referrals from dialysis-
related professional organizations and a literature review, on the
factors that they consider likely to result in above average doses of
injectable ESRD drugs. A majority of these experts identified
primarily clinical factors as likely to result in above average doses
of these drugs. For example, at least 50 percent of the 73 clinicians
and researchers from whom GAO obtained information identified 14
factors (including chronic blood loss and low iron stores) as likely
to result in above average doses of erythropoiesis stimulating agents,
which accounted for about 75 percent of expenditures on injectable
ESRD drugs in 2007.
CMS‘s proposed design for the new payment system for dialysis care
includes, as required by law, two payment mechanisms to address
differences across beneficiaries in their costs of dialysis care.
Under the first payment mechanism”a case-mix adjustment”CMS proposed
to adjust payments based on characteristics such as age, sex, and
certain clinical conditions that are associated with beneficiaries‘
costs of dialysis care. The second proposed payment mechanism”an
outlier policy”involves making additional payments to providers when
they treat patients whose costs of care are substantially higher than
would be expected.
CMS‘s preliminary plans for monitoring the effects of the new payment
system build on existing initiatives, but it is unclear whether CMS
will monitor the effects on the quality of and access to dialysis care
for groups of beneficiaries. In prior work, GAO and others have
emphasized the importance of monitoring both the quality of and access
to care to ensure that Medicare payment system changes do not result
in certain groups of beneficiaries experiencing poor care quality or
problems accessing services. CMS intends to monitor the quality of
dialysis care under the new payment system, but the extent to which
CMS will conduct such monitoring for various groups of beneficiaries
is currently unclear because CMS‘s plans are preliminary. Furthermore,
CMS‘s preliminary plans for monitoring access to dialysis care are
limited. However, CMS has stated that it will have a comprehensive
monitoring strategy in place by January 2011.
GAO obtained comments on a draft of this report from CMS and from
industry groups representing both large and small dialysis providers
and nephrologists.
What GAO Recommends:
GAO recommends that CMS begin monitoring access to and quality of
dialysis care for certain beneficiary groups as soon as possible after
implementation of the new payment system. CMS agreed with this
recommendation.
View [hyperlink, http://www.gao.gov/products/GAO-10-295] or key
components. For more information, contact James C. Cosgrove at (202)
512-7114 or cosgrovej@gao.gov.
[End of section]
Contents:
Letter:
Background:
Certain Groups of Beneficiaries, Including African Americans and Those
with Medicaid Coverage, Had Above Average Expenditures for Injectable
ESRD Drugs in 2007:
A Majority of Selected Clinicians and Researchers Identified Primarily
Clinical Factors as Likely to Result in Above Average Doses of
Injectable ESRD Drugs:
CMS Proposed Several Case-Mix Adjustment Factors and an Outlier Policy
to Address Cost Differences among Beneficiaries:
CMS's Preliminary Monitoring Plans Build on Existing Initiatives, but
Whether CMS Will Monitor Quality of and Access to Care for Groups of
Beneficiaries Is Unclear:
Conclusions:
Recommendation for Executive Action:
Agency and Industry Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: GAO Data Collection Instrument on Dose of Dialysis-
Related Drugs:
Appendix III: Medicare Expenditures for Injectable ESRD Drugs by
Demographic Characteristics:
Appendix IV: Detailed Results from Data Collection Instrument on Dose
of Dialysis-Related Drugs:
Appendix V: Comments from the Centers for Medicare & Medicaid Services:
Appendix VI: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of ESAs:
Table 2: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of IV Iron:
Table 3: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of IV Vitamin D:
Table 4: Current CMS Initiatives to Monitor the Quality of Dialysis
Care:
Table 5: Average Monthly Medicare Expenditures per Beneficiary for
Injectable ESRD Drugs by Demographic Characteristics, 2007:
Table 6: Percentage of Selected Clinicians and Researchers Indicating
Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-
Average Dose of ESAs:
Table 7: Percentage of Selected Clinicians and Researchers Indicating
Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-
Average Dose of IV Iron:
Table 8: Percentage of Selected Clinicians and Researchers Indicating
Whether a Factor Is Likely or Not Likely to Result in a Higher-Than-
Average Dose of IV Vitamin D:
Figures:
Figure 1: Average Monthly Medicare Expenditures on Injectable ESRD
Drugs by Race, 2007:
Figure 2: Average Monthly Medicare Expenditures on Injectable ESRD
Drugs by Age, 2007:
Figure 3: Crosswalk between Race and Ethnicity Categories on CMS
Medical Evidence Forms and the Categories Used in This Report:
Abbreviations:
AV: arteriovenous:
BMI: body mass index:
CMS: Centers for Medicare & Medicaid Services:
CPM: clinical performance measure:
CROWNWeb: Consolidated Renal Operations in a Web-Enabled Network:
EDB: Enrollment Database:
ESA: erythropoiesis stimulating agent:
ESRD: end-stage renal disease:
FDA: Food and Drug Administration:
HHS: Department of Health and Human Services:
IV: intravenous:
KCC: Kidney Care Council:
MedPAC: Medicare Payment Advisory Commission:
MIPPA: Medicare Improvements for Patients and Providers Act of 2008:
NRAA: National Renal Administrators Association:
PTH: parathyroid hormone:
QIP: quality incentive program:
REMIS: Renal Management Information System:
RPA: Renal Physicians Association:
UM-KECC: University of Michigan Kidney Epidemiology and Cost Center:
USRDS: United States Renal Data System:
VA: Department of Veterans Affairs:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
March 31, 2010:
The Honorable Pete Stark:
Chairman:
Subcommittee on Health:
Committee on Ways and Means:
House of Representatives:
The Honorable John Lewis:
Chairman:
Subcommittee on Oversight:
Committee on Ways and Means:
House of Representatives:
Medicare covers dialysis--a process that removes excess fluids and
toxins from the bloodstream--for most individuals with end-stage renal
disease (ESRD), a condition of permanent kidney failure.[Footnote 1]
Since the implementation of Medicare's coverage for dialysis care in
1973, hundreds of thousands of lives have been extended through
Medicare-covered dialysis treatment. In 2007, Medicare's dialysis
population numbered about 414,000, and program expenditures for
dialysis and injectable ESRD drugs were about $6.8 billion.[Footnote
2] Beginning in 2011, the Centers for Medicare & Medicaid Services
(CMS), the agency within the Department of Health and Human Services
(HHS) that administers Medicare, will change how Medicare pays for
dialysis and related services to better encourage the efficient
provision of care.[Footnote 3] Policymakers and others have raised
questions about how this change could affect ESRD beneficiaries.
[Footnote 4]
For payment purposes, CMS currently divides dialysis and related
services into two groups--one group that is paid for under a single
payment and a second group in which services are paid for on a per-
service basis. The first group includes dialysis treatment and
associated routine services such as nursing, supplies, and equipment.
Medicare pays for services in this group under a single payment--
referred to as the composite rate--which is a common form of Medicare
payment also known as bundling.[Footnote 5] Medicare uses bundled
payments in order to give providers a financial incentive to furnish
care efficiently, as providers retain the difference if Medicare's
payment exceeds the costs of providing services. On the other hand,
providers bear financial liability if the cost of beneficiaries' care
exceeds Medicare's payment. Under the current payment system for
dialysis care, Medicare uses what is known as a case-mix adjustment to
adjust the composite rate in order to account for basic differences in
beneficiaries' expected care needs and therefore in the cost of their
dialysis care.[Footnote 6] These differences can be related to
beneficiaries' demographic and clinical characteristics. Medicare pays
for a second group of dialysis-related services, which were either not
routine or not available in 1983 when Medicare implemented the
composite rate, on a per-service basis. These separately billable
services include injectable ESRD drugs as well as services such as
laboratory tests and supplies that are used during the course of
dialysis. Injectable ESRD drugs accounted for about 86 percent of
Medicare expenditures on all separately billable ESRD services in 2007.
Because providers can receive more Medicare payments for prescribing
more injectable ESRD drugs, we and others have raised concerns that
paying for this care on a per-service basis creates an incentive to
use more of these drugs than necessary.[Footnote 7] Such use could
have adverse effects on ESRD patients and contribute to unnecessary
Medicare spending. In 2006, we recommended using a single bundled
payment for dialysis care because it would improve efficiency by
reducing the incentive to use more injectable ESRD drugs than
necessary.[Footnote 8]
The Medicare Improvements for Patients and Providers Act of 2008
(MIPPA) requires CMS to implement a new expanded bundled payment
system for dialysis care beginning on January 1, 2011.[Footnote 9] In
September 2009, CMS issued a proposed rule that described the design
of the expanded bundled payment system in addition to preliminary
plans for monitoring the quality of dialysis care beneficiaries
receive once the system is implemented.[Footnote 10] Under this new
payment system, CMS will use a single bundled payment to cover all
ESRD services that are currently covered under the composite rate or
are paid for separately.[Footnote 11] MIPPA requires that CMS use a
case-mix adjustment to account for differences across beneficiaries in
the cost of their dialysis care, which could be related to
beneficiaries' demographic and clinical characteristics.[Footnote 12]
MIPPA also requires CMS to have an outlier policy, which involves
making payments to providers in addition to the bundled payment for
beneficiaries whose costs of care are substantially higher than would
be expected for these beneficiaries. There are concerns, however, that
if the case-mix adjustment and outlier policy do not adequately
account for differences across beneficiaries in the cost of care, some
beneficiaries could have their access to or quality of dialysis care
adversely affected. Specifically, providers may be discouraged from
treating or provide poor quality care to certain groups of
beneficiaries. Beneficiaries who require higher-than-average doses, or
amounts, of injectable ESRD drugs may be particularly vulnerable to
the potential of such adverse effects on access and quality because of
their above average costs for these services.
You asked us to report on the characteristics of beneficiaries with
above average doses of injectable ESRD drugs who therefore may be
particularly vulnerable to adverse effects under the new bundled
payment system for dialysis services, and on ways to ensure that such
beneficiaries have adequate access to and quality of dialysis care.
This report (1) provides information on Medicare expenditures for
injectable ESRD drugs, by beneficiaries' demographic characteristics;
(2) identifies the factors that clinicians and researchers indicate
are likely to result in a higher-than-average dose of injectable ESRD
drugs for a dialysis patient; (3) describes CMS's approach for
addressing differences among beneficiaries in the cost of dialysis
care under the new bundled payment system for these services; and (4)
examines CMS's plans for monitoring the effects of the new bundled
payment system on beneficiaries.
To provide information on Medicare expenditures for injectable ESRD
drugs, by beneficiaries' demographic characteristics, we analyzed the
most recent available data from a national data system containing
information on beneficiaries with ESRD. Specifically, we obtained 2007
data from the United States Renal Data System (USRDS) for 326,899 of
the 413,540 Medicare beneficiaries on dialysis that year.[Footnote
13],[Footnote 14] We calculated monthly Medicare expenditures per
beneficiary on injectable ESRD drugs in 2007.[Footnote 15],[Footnote
16] We focused our analysis on three types of injectable ESRD drugs--
erythropoiesis stimulating agents (ESA), intravenous (IV) iron, and IV
vitamin D--because they accounted for about 98 percent of the
approximately $2.2 billion in Medicare expenditures for injectable
ESRD drugs in 2007. We analyzed these expenditures across the
following demographic characteristics available through the USRDS
database: age, sex, race, ethnicity, urban/rural residential location,
and whether a beneficiary was enrolled in Medicaid.[Footnote 17] We
did not examine the extent to which the associations we report on
between demographic characteristics and Medicare expenditures reflect
underlying clinical or other factors. The USRDS data we analyzed on
race and ethnicity are based on subjective determinations of
beneficiaries' racial and ethnic identity. We assessed the reliability
of the USRDS data we used by interviewing officials responsible for
producing these data, reviewing relevant documentation, comparing the
results to published sources, and examining the data for obvious
errors. We determined that the data were sufficiently reliable for the
purposes of our study. (See appendix I for more detail on our scope,
methodology, and data reliability.)
To identify the factors that clinicians and researchers indicate are
likely to result in a higher-than-average dose of injectable ESRD
drugs (specifically, ESAs, IV iron, and IV vitamin D) for a dialysis
patient, we developed a structured data collection approach that
included interviews with representatives of relevant industry groups,
clinicians, and researchers with expertise in ESRD as well as the
administration of a Web-based data collection instrument to selected
nephrology clinicians and ESRD researchers. Specifically, we conducted
20 structured interviews with representatives of dialysis
organizations and dialysis-related professional organizations,
nephrology clinicians, and researchers with expertise in ESRD to
develop the data collection instrument and provide context for our
findings. We also reviewed the clinical literature related to the use
of these three types of injectable drugs. We used information from
these interviews and our analysis of Medicare expenditures on
injectable ESRD drugs to compile a list of factors that may affect the
dose of each of the three types of these drugs in our review. Our Web-
based data collection instrument asked clinicians and researchers to
identify which demographic and clinical factors were more likely to
result in a higher-than-average dose for each type of drug. In August
and September 2009, we sent our data collection instrument to 131
clinicians and researchers based on referrals from dialysis-related
professional organizations and a systematic review of the
literature.[Footnote 18] (See appendix I for more information on the
criteria used to select potential clinicians and researchers and
appendix II for the data collection instrument.) Our results represent
the opinions of 73 of these selected clinicians and researchers and
are not generalizable to a larger population.
To describe CMS's approach for addressing differences among
beneficiaries in the cost of dialysis care under the new bundled
payment system for these services, we reviewed CMS's proposed rule on
the design of this new payment system.[Footnote 19] We also reviewed
reports on the design of this payment system by HHS and the University
of Michigan Kidney Epidemiology and Cost Center (UM-KECC), which has
assisted CMS with the payment system's design. In addition, we
interviewed representatives of the Department of Veterans Affairs (VA)
and two large health plans to obtain contextual information about
other bundled payment systems.[Footnote 20],[Footnote 21] Finally, to
examine CMS's plans for monitoring the effects of the new bundled
payment system on beneficiaries, we interviewed CMS officials and
reviewed prior reports as well as CMS's proposed rule on the design of
the new bundled payment system.
We conducted this performance audit from November 2008 through March
2010 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.
Background:
ESRD is a condition of permanent kidney failure.[Footnote 22]
Treatment options include kidney transplantation and maintenance
dialysis. Kidney transplants are not a practical option on a wide
scale, as suitable donated organs are scarce. In contrast, dialysis is
the treatment used by most beneficiaries with ESRD. Hemodialysis, the
most common form of dialysis,[Footnote 23] is generally administered
three times a week at facilities that provide dialysis services.
[Footnote 24],[Footnote 25] During hemodialysis, a machine pumps blood
through an artificial kidney, called a hemodialyzer, and returns the
cleansed blood to the body. In order to receive hemodialysis
treatment, patients must have a vascular access, which is a site on
the body where blood is removed and returned during dialysis.[Footnote
26]
One of the complications of ESRD is anemia, a condition in which an
insufficient number of red blood cells is available to carry oxygen
throughout the body. A diagnosis of anemia is determined through a
measurement of the level of hemoglobin in the blood.[Footnote 27] To
treat anemia, providers may administer ESAs intravenously in
conjunction with IV iron.[Footnote 28],[Footnote 29],[Footnote 30]
Another complication of ESRD is hyperparathyroidism, which can result
from a deficiency of vitamin D. Hyperparathyroidism is typically
diagnosed based on the level of parathyroid hormone (PTH) in the blood
and can lead to elevated phosphorus levels and low calcium levels in
the blood as well as softening of the bones.[Footnote 31] The
treatment of hyperparathyroidism includes the administration of IV
vitamin D and oral drugs such as phosphate binders and calcimimetics.
[Footnote 32]
New Bundled Payment System for Dialysis Care:
In September 2009, CMS issued its proposed rule for the design of the
new bundled payment system for dialysis care, which is required by law
for services furnished on or after January 1, 2011.[Footnote 33] CMS
proposed that under the new bundled payment system, Medicare would
continue paying dialysis facilities a bundled payment per dialysis
treatment for up to three treatments per week as it does under the
current system.[Footnote 34] However, unlike the current payment
system, the new bundled payment would cover ESRD drugs and other
separately billable services (for example, laboratory tests related to
ESRD treatment) in addition to dialysis services currently covered
under the composite rate. Under CMS's proposed rule, the ESRD drugs
covered under the new bundled payment would include injectable ESRD
drugs as well as oral ESRD drugs, such as calcimimetics, that are
currently covered under Medicare Part D.
Accounting for Beneficiary Cost Differences under Medicare Bundled
Payment Systems:
Bundled payment systems in Medicare typically include a case-mix
adjustment and may also use an outlier policy to account for
differences in the cost of beneficiaries' care. In general, a case-mix
adjustment varies payments based on factors associated with
beneficiaries' expected costs of care.[Footnote 35] As a result, a
case-mix adjustment typically increases bundled payments for providers
who treat high-cost beneficiaries. In addition, some bundled payment
systems under Medicare use an outlier policy to partially offset
providers' financial losses for treating beneficiaries whose costs of
care substantially exceed what would be expected.[Footnote 36] To
reduce these financial losses, an outlier policy involves making
provider payments in addition to the case-mix adjusted bundled rate
for these high-cost beneficiaries.
The accuracy with which bundled payments are adjusted to account for
differences in beneficiaries' expected costs of care may affect
beneficiaries' access to and quality of care. In prior work, we and
others have stated that if a bundled payment system's case-mix
adjustment is not designed adequately, then payments may be too low
for certain groups of beneficiaries.[Footnote 37] Further, providers
could respond to these inadequate payments by choosing not to treat or
inappropriately limiting care for these groups, which could adversely
affect these beneficiaries' access to and quality of care.[Footnote
38],[Footnote 39] We and others have noted that underpaying for care,
which could result from an inadequate case-mix adjustment, may result
in care of poor quality.[Footnote 40] In particular, poor quality of
care could occur under bundled payment systems if, for example,
providers furnish inadequate doses of drugs in an effort to minimize
cost. Beneficiaries with above average costs of care may be
particularly vulnerable because providers who treat these
beneficiaries face the potential of financial losses on these patients
if the bundled payments are not adjusted appropriately to take these
above average costs into account.
The potential unintended effects of bundled payment systems on
beneficiaries have led us and others to note that access to and
quality under various Medicare bundled payment systems should be
monitored.[Footnote 41] For example, in 1999, we noted that monitoring
access to care would be necessary under Medicare's bundled payment
system for skilled nursing care to ensure that Medicare beneficiaries
continued to have access to medically necessary services.[Footnote 42]
Similarly, in its 2006 report, the HHS Office of Inspector General
stressed the importance of monitoring quality under the bundled
payment system for home health care.[Footnote 43] Our work and work by
others has also noted the importance of monitoring the effect of
Medicare bundled payment systems on various groups of beneficiaries.
Specifically, in 2000 we and the Medicare Payment Advisory Commission
(MedPAC) reported on the bundled payment system for home health care
and recommended that the delivery of these services be monitored
across groups of beneficiaries, such as those whose care is more
costly than average.[Footnote 44] Furthermore, a study on the bundled
payment system for inpatient rehabilitation services affirmed the
importance of monitoring access to care for various groups of
beneficiaries.[Footnote 45]
Certain Groups of Beneficiaries, Including African Americans and Those
with Medicaid Coverage, Had Above Average Expenditures for Injectable
ESRD Drugs in 2007:
Monthly Medicare expenditures per beneficiary for injectable ESRD
drugs in 2007 were above average for certain demographic groups, and
African Americans and persons with Medicaid coverage were among the
groups for which this difference was largest. In particular, Medicare
expenditures on injectable ESRD drugs in 2007 were $782 per African
American beneficiary per month--about 13 percent more than the $693
spent for all Medicare beneficiaries on dialysis (see figure 1).
[Footnote 46],[Footnote 47] The above average spending per African
American beneficiary was due primarily to higher spending on ESAs and
IV vitamin D. Monthly Medicare spending per African American
beneficiary on ESAs was about 10 percent higher than the average
across all beneficiaries on dialysis, and spending on IV vitamin D was
about 38 percent higher than average. Average monthly Medicare
expenditures per beneficiary for other racial groups were below the
average for all beneficiaries on dialysis in 2007. As a result,
average monthly expenditures for African Americans were about 41 to 42
percent higher than spending for beneficiaries who classified
themselves as American Indian/Alaskan Native or Asian or Pacific
Islander and about 21 percent higher than for expenditures for White
beneficiaries.[Footnote 48]
Figure 1: Average Monthly Medicare Expenditures on Injectable ESRD
Drugs by Race, 2007:
[Refer to PDF for image: stacked vertical bar graph]
Monthly Medicare expenditures per beneficiary:
Race: White
ESAs: $490;
IV vitamin D: $78;
IV iron: $59;
Other injectable drugs[A]: $19;
Total: $645.
Race: African American;
ESAs: $566;
IV vitamin D: $141;
IV iron: $62;
Other injectable drugs[A]: $14;
Total: $782.
Race: Asian or Pacific Islander;
ESAs: $421;
IV vitamin D: $75;
IV iron: $45;
Other injectable drugs[A]: $10;
Total: $552.
Race: American Indian/Alaskan Native;
ESAs: $416;
IV vitamin D: $79;
IV iron: $48;
Other injectable drugs[A]: $11;
Total: $555.
Race: Other/unknown;
ESAs: $452;
IV vitamin D: $105;
IV iron: $49;
Other injectable drugs[A]: $8;
Total: $615.
Race: All;
ESAs: $515;
IV vitamin D: $102;
IV iron: $59;
Other injectable drugs[A]: $16;
Total: $693.
Source: Data from the United States Renal Data System for 2007.
Note: Dollar amounts may not sum to totals because of rounding.
[A] Other injectable drugs include Levocarnitine (used to address a
deficiency in carnitine, which helps the body produce energy),
Alteplase (used to restore blood flow through a patient's vascular
access), and Vancomycin (an antibiotic used for treatment of certain
infections).
[End of figure]
Average monthly expenditures per beneficiary for injectable ESRD drugs
were also above average for beneficiaries enrolled in both Medicare
and Medicaid. Specifically, average monthly expenditures per
beneficiary enrolled in Medicare and Medicaid were $735 in 2007, which
was about 6 percent higher than the $693 spent across all
beneficiaries on dialysis and about 12 percent higher than the $659
for Medicare beneficiaries who were not in Medicaid. This difference
was mainly due to above average expenditures on ESAs and IV vitamin D
for beneficiaries enrolled in both Medicare and Medicaid. For
beneficiaries with both Medicare and Medicaid coverage, expenditures
on ESAs were about 6 percent higher than the average for all
beneficiaries in 2007, while expenditures on IV vitamin D were about
11 percent higher than average.
Monthly Medicare expenditures per beneficiary for adults age 20 to 64
were generally higher than the average for all Medicare beneficiaries
on dialysis. Most notably, Medicare spending per beneficiary age 20 to
44 was about 9 percent more than the monthly average for all Medicare
beneficiaries on dialysis (see figure 2). Monthly Medicare
expenditures per beneficiary age 20 to 44 were also higher when
compared to those of other age groups, in particular beneficiaries age
19 and under or age 75 and older. The higher-than-average spending for
beneficiaries age 20 to 44 was driven primarily by above average
expenditures on ESAs and IV vitamin D. Specifically, Medicare spending
on ESAs per beneficiary age 20 to 44 was about 9 percent higher than
the average across all beneficiaries on dialysis in 2007. Similarly,
Medicare spending on IV vitamin D per beneficiary age 20 to 44 was
about 12 percent higher than the average for all beneficiaries.
Figure 2: Average Monthly Medicare Expenditures on Injectable ESRD
Drugs by Age, 2007:
[Refer to PDF for image: stacked vertical bar graph]
Monthly Medicare expenditures per beneficiary:
Age: 0-19;
ESAs: $322;
IV vitamin D: $62;
IV iron: $29;
Other injectable drugs[A]: $27;
Total: $441.
Age: 20-44;
ESAs: $562;
IV vitamin D: $114;
IV iron: $57;
Other injectable drugs[A]: $20;
Total: $755.
Age: 44-54;
ESAs: $536;
IV vitamin D: $116;
IV iron: $58;
Other injectable drugs[A]: $15;
Total: $724.
Age: 55-64;
ESAs: $515;
IV vitamin D: $109;
IV iron: $57;
Other injectable drugs[A]: $17;
Total: $698.
Age: 65-74;
ESAs: $516;
IV vitamin D: $99;
IV iron: $61;
Other injectable drugs[A]: $16;
Total: $692.
Age: 75+;
ESAs: $472;
IV vitamin D: $81;
IV iron: $62;
Other injectable drugs[A]: $15;
Total: $630.
Age: All;
ESAs: $515;
IV vitamin D: $102;
IV iron: $59;
Other injectable drugs[A]: $16;
Total: $693.
Source: Data from the United States Renal Data System for 2007.
Note: Dollar amounts may not sum to totals because of rounding.
[A] Other injectable drugs include Levocarnitine (used to address a
deficiency in carnitine, which helps the body produce energy),
Alteplase (used to restore blood flow through a patient's vascular
access), and Vancomycin (an antibiotic used for treatment of certain
infections).
[End of figure]
Monthly expenditures per beneficiary in 2007 for females, non-Hispanic
beneficiaries, and urban residents also exceeded the average for all
beneficiaries on dialysis, but to a lesser extent than for African
Americans and beneficiaries in both Medicare and Medicaid. For
example, female beneficiaries had average monthly expenditures of
$715, which was about 3 percent higher than the monthly average across
all Medicare beneficiaries on dialysis and about 6 percent higher than
monthly expenditures per male beneficiary. Similarly, the $708 that
Medicare spent per month on non-Hispanic beneficiaries was about 2
percent higher than the average across all beneficiaries on dialysis
and about 19 percent higher than the average for Hispanic
beneficiaries.
For more detailed information on Medicare expenditures for injectable
ESRD drugs, by demographic characteristics, see appendix III.
A Majority of Selected Clinicians and Researchers Identified Primarily
Clinical Factors as Likely to Result in Above Average Doses of
Injectable ESRD Drugs:
While we report that certain demographic groups were associated with
above average Medicare expenditures for injectable ESRD drugs in 2007,
we did not identify the factors that led to these differences in
expenditures across groups of beneficiaries. However, we collected
information from nephrology clinicians and ESRD researchers on the
factors they consider likely to result in above average doses of
injectable drugs--ESAs, IV iron, and IV vitamin D.
A majority of the 73 clinicians and researchers who completed our Web-
based data collection instrument identified clinical factors, rather
than demographic characteristics, as likely to result in above average
doses of injectable ESRD drugs. Specifically, at least 50 percent of
these experts identified 14 such factors, including chronic blood
loss, low iron stores, and recent hospitalization, as likely to result
in above average doses of ESAs (see table 1).[Footnote 49] Further, a
majority of the clinicians and researchers who completed our data
collection instrument indicated that demographic factors were not
likely to result in above average doses of ESAs. Specifically, at
least 50 percent of these experts identified 16 of the 17 demographic
factors, such as age, race, and socioeconomic status, as not likely to
result in above average doses of ESAs (see appendix IV for detailed
results). These results are consistent with information from our
structured interviews with nephrology clinicians, who indicated that
they consider clinical factors, rather than demographic
characteristics, when making dosing decisions for ESAs and other
injectable ESRD drugs.
Table 1: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of ESAs:
Clinical factors:
Factor: Chronic blood loss;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Concurrent treatment with antihypertensive medication;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Fewer than 4 months on dialysis;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Hemoglobin production disorders;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Inadequate dialysis;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Infection or inflammatory conditions;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Large body size;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Low hemoglobin level;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Low iron stores;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Malnutrition;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Nonadherence to dialysis treatment;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Nonadherence to ESA treatment;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Nonadherence to iron treatment;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Recent hospitalization;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Refusal to receive immunizations;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Use of a dialysis catheter;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Demographic factors:
Factor: Age: 0-19;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 20-44;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 45-54;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 55-64;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 65-74;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 75+;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Non-Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: African American;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: Other;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: White;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Residential location: Rural;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Residential location: Urban;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: Low;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: High;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Factor: Sex: Female;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Sex: Male;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Source: GAO's August and September 2009 data collection instrument on
the dose of dialysis-related drugs.
Notes: Results are based on information from 73 clinicians and
researchers. The list of clinical factors above for ESAs is based on
information obtained from 20 structured interviews with
representatives of dialysis organizations and dialysis-related
professional organizations, nephrology clinicians, and ESRD
researchers. See appendices I and II for more information on our data
collection instrument.
[End of table]
The literature we reviewed on the use of ESAs provides some
explanation for how clinical factors impact the dose of this drug. For
example, chronic blood loss is a common occurrence among hemodialysis
patients. Blood loss can increase a person's ESA requirements by
reducing the level of iron in the blood. Sources of blood loss include
blood lost during the hemodialysis process, regular blood draws for
laboratory testing, and gastrointestinal bleeding. As another example,
the clinical literature describes how recent hospitalizations relate
to ESA use. Studies demonstrate that hospitalized ESRD patients
usually experience a decline in hemoglobin levels, which worsens
anemia and increases posthospitalization ESA requirements.[Footnote
50] The literature offers multiple explanations for this decline in
hemoglobin levels. For example, hospitalized ESRD patients commonly
experience infection, inflammation, and iron deficiency.[Footnote 51]
All of these conditions can contribute to increased ESA requirements.
[Footnote 52] Additionally, the literature explains the effect of
dialysis catheters on the use of ESAs. According to published
research, the use of dialysis catheters compared to other forms of
vascular access makes ESRD patients more prone to infection and
inflammation, which increase ESA requirements.[Footnote 53]
As with ESAs, a majority of clinicians and researchers who completed
our data collection instrument identified clinical factors, such as
chronic blood loss and low iron stores, as likely to result in above
average doses of IV iron (see table 2). These individuals identified
six clinical factors as likely to result in above average doses of IV
iron. Five of these six clinical factors overlap with the clinical
factors identified for ESAs.[Footnote 54] Moreover, at least 50
percent of clinicians and researchers who completed our data
collection instrument identified demographic factors, such as age,
race and residential location, as not likely to result in an above
average dose of IV iron (see appendix IV for detailed results).
Table 2: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of IV Iron:
Clinical factors:
Factor: Chronic blood loss;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Concurrent treatment with ESAs;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Fewer than 4 months on dialysis;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Inadequate dialysis;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Infection or inflammatory conditions;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Large body size;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Low iron stores;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Malnutrition;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Recent hospitalization;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Refusal to receive immunizations;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Demographic factors:
Factor: Age: 0-19;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 20-44;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 45-54;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 55-64;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 65-74;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 75+;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Non-Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: African American;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: Other;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: White;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Residential location: Rural;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Residential location: Urban;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: Low;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: High;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Factor: Sex: Female;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Sex: Male;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Source: GAO's August and September 2009 data collection instrument on
the dose of dialysis-related drugs.
Notes: Results are based on information from 73 clinicians and
researchers. The list of clinical factors above for IV iron is based
on information obtained from 20 structured interviews with
representatives of dialysis organizations, dialysis-related
professional organizations, nephrology clinicians, and ESRD
researchers. See apps. I and II for more information on our data
collection instrument.
[End of table]
Also similar to ESAs, the literature on the use of IV iron provides
some context for the clinical factors that are likely to result in
above average doses of IV iron. For example, chronic blood loss can
result in iron deficiency and increase a person's IV iron requirement.
[Footnote 55] Sources of blood loss leading to increased IV iron
requirements include blood retention in the dialyzer tubing, blood
testing, and gastrointestinal bleeding.[Footnote 56] Also, the
literature explains that the state of having low iron stores is more
common in patients on dialysis for less than 6 months than those on
dialysis for longer amounts of time.[Footnote 57]
As table 3 shows, a majority of the clinicians and researchers who
completed our data collection instrument identified two clinical
factors--hyperparathyroidism and a lack of predialysis care--and one
demographic factor--low socioeconomic status--as likely to result in
higher-than-average doses of IV vitamin D (see appendix IV for
detailed results). Hyperparathyroidism is present in almost all ESRD
patients and develops early in the course of chronic kidney disease.
In fact, research shows that PTH levels start to increase early in the
course of chronic kidney disease and can lead to the development of
hyperparathyroidism.[Footnote 58] In addition, new ESRD patients who
have not received predialysis care from a nephrologist may be at
greater risk of health complications.[Footnote 59] According to the
clinical literature, new ESRD patients may begin dialysis treatment
without receiving predialysis care from a nephrologist because they
face barriers to receiving care.[Footnote 60],[Footnote 61] One such
barrier is low socioeconomic status.[Footnote 62] Specifically, the
literature shows that low socioeconomic status may be associated with
limited access to health care services.[Footnote 63]
Table 3: Factors Identified by Selected Clinicians and Researchers as
Likely or Not Likely to Result in Above Average Doses of IV Vitamin D:
Clinical factors:
Factor: Hyperparathyroidism;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Lack of predialysis care;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Check];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Malnutrition;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Demographic factors:
Factor: Age: 0-19;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 20-44;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 45-54;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 55-64;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 65-74;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Age: 75+;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Ethnicity: Non-Hispanic;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: African American;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: Other;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Race: White;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Factor: Residential location: Rural;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Residential location: Urban;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: Low;
Percentage who responded "likely": At least 50 percent: [Check];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Empty];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Socioeconomic status: High;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Check].
Factor: Sex: Female;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Factor: Sex: Male;
Percentage who responded "likely": At least 50 percent: [Empty];
Percentage who responded "likely": At least 75 percent: [Empty];
Percentage who responded "not likely": At least 50 percent: [Check];
Percentage who responded "not likely": At least 75 percent: [Empty].
Source: GAO's August and September 2009 data collection instrument on
the dose of dialysis-related drugs.
Notes: Results are based on information from 73 clinicians and
researchers. The list of clinical factors above for IV vitamin D is
based on information obtained from 20 structured interviews with
representatives of dialysis organizations and dialysis-related
professional organizations, nephrology clinicians, and ESRD
researchers. See appendices I and II for more information on our data
collection instrument.
[End of table]
CMS Proposed Several Case-Mix Adjustment Factors and an Outlier Policy
to Address Cost Differences among Beneficiaries:
Issued in September 2009, CMS's proposed rule for the new bundled
payment system for dialysis care identified several clinical and
demographic factors that the agency proposed to use in the case-mix
adjustment model required by MIPPA.[Footnote 64] The case-mix
adjustment factors that CMS proposed include age, sex, body surface
area, body mass index, length of time on dialysis, and comorbid
conditions.[Footnote 65],[Footnote 66] CMS and UM-KECC studied the
relationship between these proposed factors and the cost of dialysis
care and used the results to determine how to adjust payments under
the new bundled payment system. For example, based on CMS's proposed
case-mix adjustment, the bundled payment for a beneficiary who has
been on dialysis for fewer than 4 months would be 47 percent higher
than the payment for the same beneficiary on dialysis for more than 4
months.
CMS used the criteria listed below to select potential case-mix
adjustment factors.[Footnote 67] Specifically, a factor:
* had to have a statistically significant relationship with
beneficiaries' costs of dialysis care that was large enough to result
in an economically meaningful difference in payments to providers,
* could not introduce incentives for providers to furnish
inappropriate or poor quality care,
* must be measured based on objective guidelines, and:
* must be based on reliable data.
CMS considered some factors as potential case-mix adjusters but did
not propose them because they did not meet CMS's criteria.[Footnote
68] One example of a factor that CMS considered but did not propose as
a potential case-mix adjuster is congestive heart failure. CMS
officials stated that they did not propose this factor in part because
of the lack of clear and objective guidelines for diagnosing this
condition. As another example, a beneficiary's prior ESA use was not
proposed as a case-mix adjuster because, according to CMS officials,
this factor would introduce inappropriate incentives for providers.
Specifically, they concluded that if the extent of prior ESA use were
a case-mix adjustment factor, a provider would have the incentive to
increase a beneficiary's ESA dose to obtain higher Medicare payments
under the new bundled payment system.
CMS also considered including race and ethnicity in the proposed case-
mix adjustment model, but chose not to include these factors. CMS
invited public comment on this decision, noting that an adjustment
based on race and ethnicity may be warranted.[Footnote 69] One of the
reasons CMS cited in its proposed rule for not including race and
ethnicity in the proposed model was the lack of objective guidelines
for classifying beneficiaries' race or ethnicity.[Footnote 70] This
absence of objective guidelines implies that there is likely to be an
inconsistency across individuals in how they classify themselves into
racial or ethnic categories. CMS also noted that its concerns with the
quality of data on race and ethnicity made it difficult to propose
these variables as case-mix adjusters.[Footnote 71] One quality issue
that CMS cited is the inconsistency over time in how Medicare data on
race and ethnicity were collected for one of its two sources of this
information--the Renal Management Information System (REMIS) database.
[Footnote 72] Additionally, CMS cited studies indicating that
information on race and ethnicity from Medicare's second source of
these data--the Medicare Enrollment Database (EDB)--may be inaccurate.
These studies found that the EDB may not accurately identify
beneficiaries' race and ethnicity, particularly for beneficiaries in
smaller minority groups, such as Asians and Hispanics.[Footnote 73]
In addition to a case-mix adjustment model, CMS proposed using an
outlier policy, as required by MIPPA, to increase payments to
providers when they treat beneficiaries whose costs of dialysis care
substantially exceed what would be expected. CMS proposed identifying
these high-cost beneficiaries based on their cost of outlier services,
which CMS defines as ESRD services that are separately billable under
the current payment system for dialysis care, such as injectable ESRD
drugs.[Footnote 74] The agency has noted that it is primarily the
variation in the cost of outlier services that poses a financial risk
to providers and that could therefore adversely affect beneficiaries'
access to and quality of dialysis care. Furthermore, according to CMS
officials, the agency collects beneficiary-level data on the use of
outlier services but not on those covered under the composite rate,
such as the dialysis procedure.[Footnote 75] Such data would be
necessary to identify beneficiaries with higher-than-expected costs
for dialysis care overall. Based on CMS's proposed outlier policy,
providers could receive outlier payments when they treat beneficiaries
whose costs for injectable ESRD drugs and other outlier services
exceed a certain threshold.[Footnote 76]
The case-mix adjustment and outlier policy may need to be recalibrated
periodically. The specific parameters of these payment mechanisms
initially will be based on patterns of utilization, and therefore
spending, that existed before the new bundled payment system was
implemented. The bundling of payments changes financial incentives for
providers and is intended to encourage the efficient provision of
care. To the extent that providers change how they practice after the
new payment system is implemented, in response to the financial
incentives of the new bundled payment system to provide dialysis care
more efficiently or other factors, the parameters of the case-mix
adjustment and outlier policy could become less accurate over time. As
a result, CMS officials stated that they may recalibrate these payment
mechanisms using data collected after implementation of the new
bundled payment system. However, CMS officials noted that they had not
established a time frame for this recalibration.
CMS's Preliminary Monitoring Plans Build on Existing Initiatives, but
Whether CMS Will Monitor Quality of and Access to Care for Groups of
Beneficiaries Is Unclear:
CMS officials told us that their preliminary plans for monitoring the
effects of the new bundled payment system on beneficiaries include
three current CMS initiatives that focus on monitoring the quality of
dialysis care (see table 4). In comments on a draft of this report,
CMS reported that it plans to have a comprehensive monitoring strategy
in place when the new bundled payment system is implemented on January
1, 2011. One of the three key initiatives in CMS's preliminary
monitoring plans is its network of 18 private organizations--called
ESRD networks. Each network is charged with monitoring and promoting
the quality of dialysis care in a geographic area, which generally
covers one or more states. The networks' monitoring responsibilities
include analyzing facility-level data on quality measures to identify
facilities that need assistance with quality improvement.[Footnote 77]
The networks are also responsible for evaluating and addressing
patient complaints. The second quality monitoring initiative that CMS
plans to rely on is the Clinical Performance Measures (CPM) project.
Under this project, CMS has monitored quality by collecting and
analyzing data on dialysis quality measures for a nationally
representative sample of beneficiaries on dialysis. CMS has used these
data to report annually on comparisons of the quality of dialysis care
across the country and across groups of beneficiaries. The third
initiative involves monitoring the quality of individual dialysis
facilities by ensuring that they comply with Medicare's conditions for
coverage that a facility must fulfill in order to receive Medicare
payment for dialysis care. One of these conditions requires that a
dialysis facility develop and implement a program to monitor and
improve the quality of services it provides.[Footnote 78] CMS requires
that this plan include the collection and monitoring of data on
patient satisfaction with care and the adequacy of dialysis, among
other measures.
Table 4: Current CMS Initiatives to Monitor the Quality of Dialysis
Care:
Quality initiative: ESRD networks;
Description:
Network responsibilities include:
* monitoring facility-level indicators of the quality of dialysis
care, such as anemia management and dialysis adequacy;
* evaluating and resolving patient complaints and grievances;
* collecting data on and tracking beneficiaries who were discharged
from dialysis facilities involuntarily;
* providing technical assistance to dialysis facilities in developing
and implementing quality improvement projects; and;
* identifying dialysis facilities not meeting network goals and
assisting facilities in developing appropriate plans for correction.
Quality initiative: Clinical Performance Measures (CPM) project;
Description: Under this project, CMS has collected, analyzed, and
reported data on CPMs. The CPMs that CMS currently uses cover the
following topics: (1) anemia management; (2) dialysis adequacy;
(3) mineral metabolism; (4) vascular access; (5) influenza vaccination;
(6) patient education, perception of care, and quality of life; and
(7) mortality.
Quality initiative: Survey and certification program;
Description: Facilities' compliance with Medicare's conditions for
coverage is monitored through on-site inspections--called surveys,
which are conducted by state survey agencies. Facilities must comply
with these conditions in order for CMS to certify them to be paid for
Medicare-covered dialysis services. The conditions for coverage
address issues such as patient safety and care.
Source: GAO review of CMS documentation.
[End of table]
In addition to the monitoring initiatives described above, CMS has or
is developing two other quality initiatives focused primarily on
promoting the quality of dialysis care rather than monitoring. The
first of these initiatives that CMS plans to continue under the new
bundled payment system is Dialysis Facility Compare, which is a tool
on the Medicare program's Web site that allows users to compare
dialysis facilities based on measures of the quality of dialysis care.
By making public each facility's quality information, Dialysis
Facility Compare gives facilities the incentive to improve the quality
of care they furnish. CMS is developing the second of these
initiatives--a quality incentive program (QIP)--which is required by
MIPPA to be implemented beginning January 1, 2012. Under the QIP,
Medicare is required to reduce payments to dialysis providers by up to
2 percent if the dialysis care they furnish does not meet a total
performance score based on quality standards established by CMS.
[Footnote 79] CMS proposed using indicators of dialysis adequacy and
anemia management to measure quality under the QIP.[Footnote 80] By
linking a portion of provider payments to measures of dialysis
adequacy and anemia management, the QIP would give providers a
financial incentive to improve these aspects of dialysis care.
However, the QIP would not address other aspects of dialysis care,
such as mineral metabolism, which is related to the use of IV vitamin
D, unless CMS incorporated additional measures into the program.
[Footnote 81]
We and others have noted the importance of monitoring quality of and
access to care under bundled payment systems to help ensure that
beneficiaries receive appropriate care.[Footnote 82] Although CMS
intends to monitor quality under the new bundled payment system, the
extent to which CMS will conduct such monitoring for various groups of
beneficiaries is uncertain. CMS officials told us that it was too
early in the process of developing a monitoring plan to address how
they might monitor various groups of beneficiaries. CMS is developing
the capacity to monitor the quality of dialysis care for groups of
beneficiaries, such as those with above average costs of care.
Specifically, CMS is implementing a new database called the
Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb),
which is designed to collect CPM data as well as other clinical and
demographic information for all beneficiaries with ESRD.[Footnote 83]
However, because CMS is still developing its monitoring plans, it is
uncertain to what extent CMS will use these data to monitor the
quality of dialysis care for various groups of beneficiaries under the
new bundled payment system.
While CMS has initiatives it plans to use to monitor the quality of
dialysis care beneficiaries receive under the new bundled payment
system, these initiatives involve systematic monitoring of only one
measure of beneficiaries' access to such care. Specifically, CMS
systematically monitors the extent to which beneficiaries are
discharged involuntarily from facilities by requiring the networks to
track these beneficiaries.[Footnote 84] To improve the networks'
ability to track these beneficiaries, CMS is developing a database
designed to allow the networks to track the number of involuntary
discharges based on beneficiary characteristics, such as age, race,
and ethnicity. However, according to CMS officials, the agency does
not systematically monitor other measures of access to dialysis care,
such as the use of dialysis services.[Footnote 85]
Although CMS's monitoring initiatives do not generally focus on
beneficiaries' access to dialysis care, CMS has the data sources
necessary to conduct more comprehensive monitoring of access for
various groups of beneficiaries, including those with above average
costs of care. In particular, one data source that CMS has available
to monitor access to dialysis care is the information it generates on
the characteristics of beneficiaries receiving care in dialysis
facilities. This facility-level information--the Dialysis Facility
Report--is compiled by UM-KECC in part from Medicare claims and the
REMIS database. CMS could use these data, in addition to information
it has on which facilities open or close during a given year, to
compare the characteristics of beneficiaries in these facilities.
[Footnote 86] This information could indicate whether facility
openings and closures affect the availability of dialysis facilities
for certain groups of beneficiaries more than others.
CMS also has the data necessary to monitor other measures of access to
care, such as changes in the use of dialysis services and shifts in
the site of dialysis care. CMS collects data on the use of Medicare-
covered services, such as ESRD drugs, through the process of paying
claims for these services.[Footnote 87] In addition, the CROWNWeb
database will contain beneficiary-level data on demographic and
clinical characteristics. CMS could use these data sources to identify
groups of beneficiaries whose service use is higher than average and
who therefore may have above average costs of dialysis care. CMS could
then use these data to monitor the use of dialysis services for groups
of beneficiaries with above average costs of care. Changes in the use
of dialysis services could indicate how the new bundled payment system
may have affected beneficiaries' access to these services. For
example, if the use of a given dialysis-related drug declined over
time for certain groups of beneficiaries but not for others, then this
could prompt an assessment of whether this reduction was appropriate
and whether the payment system may have caused this difference. CMS
could also monitor the extent to which beneficiaries receive emergency
dialysis in hospitals rather than outpatient dialysis facilities as an
indicator of access to dialysis care. An increase in hospital
admissions for emergency dialysis services for certain groups of
beneficiaries could indicate that these groups are having difficulty
gaining admission to outpatient dialysis facilities.
Conclusions:
The new bundled payment system for dialysis care--required to be
implemented for services furnished on or after January 1, 2011--has
the potential to improve the efficiency of care delivery, in part by
reducing the financial incentive to use more injectable ESRD drugs
than are necessary. However, if this new payment system causes
providers to consistently experience financial losses when treating
beneficiaries with above average costs, then some beneficiaries could
face problems accessing dialysis care or with the quality of that
care. Groups of beneficiaries with above average costs of dialysis
care, whether related to clinical or demographic factors, may be more
vulnerable to these types of problems. Therefore it will be important
for CMS to monitor the effect of the new bundled payment system on the
access to and quality of dialysis care for these beneficiaries--which
is consistent with previous work on the need for such monitoring under
other bundled payment systems in Medicare. Furthermore, early
identification of any adverse effects of the payment system on
beneficiaries will be crucial because their need for life-sustaining
dialysis makes them particularly sensitive to disruptions in dialysis
care.
CMS recognizes the importance of monitoring the effect of its new
bundled payment system on beneficiaries and is developing plans for
these efforts. In commenting on a draft of this report, CMS stated
that it plans to have a comprehensive monitoring strategy in place
when the new bundled payment system is implemented on January 1, 2011.
However, because CMS's monitoring plans are preliminary, the extent to
which CMS intends to monitor quality for various groups of
beneficiaries, such as those with above average costs of care, is
unclear. Furthermore, while CMS's preliminary plans for monitoring
under the new bundled payment system contain initiatives designed to
monitor the quality of dialysis care, these plans involve very limited
monitoring of access to these services. CMS has or is developing the
tools it could use to monitor access to and quality of dialysis care
for various groups of beneficiaries, including those with above
average costs of dialysis care. Specifically, CMS currently collects
data on the use of injectable ESRD drugs and other Medicare services
that could be used to monitor access to these services. CMS is also
developing a data system that will contain quality measures for each
beneficiary with ESRD. CMS could draw on this capacity as it plans and
conducts its monitoring efforts. Moreover, CMS could use information
from these efforts to help refine the payment system over time.
Recommendation for Executive Action:
To help ensure that changes in Medicare payment methods for dialysis
care do not adversely affect beneficiaries, we recommend that the
Administrator of CMS monitor the access to and quality of dialysis
care for groups of beneficiaries, particularly those with above
average costs of dialysis care, under the new bundled payment system.
Such monitoring should begin as soon as possible once the new bundled
payment system is implemented and be used to inform potential
refinements to the payment system.
Agency and Industry Comments and Our Evaluation:
We received written comments on a draft version of this report from
CMS and oral comments on the draft report from representatives from
dialysis facility organizations and from a nephrologist specialty
association.
Comments from CMS:
In written comments on a draft of this report, CMS agreed with our
recommendation and noted that it is planning to actively monitor the
effects of the new bundled payment system on all ESRD beneficiaries,
including those with above average costs. CMS noted that it plans to
have a comprehensive monitoring strategy in place when the payment
system is implemented on January 1, 2011. In particular, CMS plans to
use its existing data sources to examine overall trends in care
delivery and quality to help the agency ensure that beneficiaries
continue to receive quality care under the new payment system. CMS
stated that it would use its existing infrastructure, including the
ESRD networks, for quality oversight in the ESRD facilities.
Furthermore, CMS indicated that it plans to use information from these
monitoring activities for potential refinements to the new bundled
payment system and the QIP.
CMS noted that our statement that the agency's preliminary plans
involve limited monitoring of access to dialysis care did not reflect
the agency's current planning efforts because our assessment was based
on interviews conducted prior to the publication of the ESRD proposed
rule, which occurred on September 29, 2009. However, we spoke with CMS
officials in December 2009 to review our evidence and findings
regarding the agency's preliminary monitoring plans, and at that time,
agency officials told us that our information was accurate.
CMS commented that our report suggests that clinical factors, rather
than demographic characteristics, are more likely to relate to higher
doses of injectable ESRD drugs, resulting in above average
expenditures for certain groups of beneficiaries. CMS also noted that
the case-mix adjustment model is designed to predict dialysis facility
costs and be used in making payments to such facilities based on
information they are able to provide on claims. CMS further noted that
demographic and other factors had been determined to be statistically
significant in predicting facility costs. The results of our study
indicate that while Medicare expenditures on injectable ESRD drugs
were related to beneficiaries' demographic characteristics, a majority
of clinicians and researchers from whom we obtained input noted that
these characteristics by themselves generally were not likely to
result in higher doses of injectable ESRD drugs. However, we do not
draw any conclusions regarding the relative importance of demographic
or clinical characteristics in predicting dialysis facility costs for
the purposes of a case-mix adjustment model and payment system.
Evaluating the appropriateness of CMS's proposed case-mix adjustment
factors was beyond the scope of this study. CMS provided technical
comments, which we incorporated as appropriate. We have reprinted
CMS's letter in appendix V.
Comments from Industry Representatives:
We invited representatives of both large and small dialysis facility
organizations and a nephrologist specialty association to review and
provide oral comments on the draft report. The groups represented were
the Kidney Care Council (KCC), the National Renal Administrators
Association (NRAA), and the Renal Physicians Association (RPA). The
three groups generally agreed with our message and recommendation to
CMS. Their comments focused on three areas: the data and populations
analyzed in the report, our findings related to beneficiaries'
demographic characteristics and clinical conditions, and the nature
and timeliness of CMS's monitoring plans. Industry representatives
also provided technical comments, which we incorporated as appropriate.
First, representatives from each of the organizations commented on the
scope of the report by raising potential issues with the data and
populations we analyzed. RPA representatives noted that our data on
Medicare expenditures for injectable ESRD drugs, which were based on
USRDS data for 2007, may not represent current trends in utilization
and expenditures. They asserted that prescribing patterns for
injectable ESRD drugs may have changed since 2007 and that this may
have been due in part to safety concerns associated with ESA use. In
addition, representatives from both KCC and NRAA stated that the
report did not sufficiently examine the socioeconomic status of ESRD
beneficiaries, including how beneficiaries with both Medicare and
Medicaid coverage would fare under the new bundled payment system. An
NRAA representative also noted that our report did not examine data on
the poorest ESRD beneficiaries who have Medicaid coverage but do not
qualify for Medicare coverage. In addition, KCC representatives noted
that the report did not provide enough information on Part D drugs,
which CMS proposed to cover under the new bundled payment system.
Moreover, RPA representatives noted that there is a great deal of
anxiety in the provider community about whether the bundled payment
will be sufficient to cover the cost of these drugs.
In our report, we analyzed USRDS data on Medicare expenditures for
injectable ESRD drugs and demographic characteristics such as age,
sex, race, and Medicaid status for 2007 because these were the most
recent data available. Moreover, our analysis of data from 2003
through 2006 indicated that the results based on 2007 data were
consistent with data from the previous 4 years. We acknowledge,
however, that the safety concerns about ESAs could have influenced
prescribing practices and that such changes could affect the
relationship between expenditures on injectable ESRD drugs and
demographic characteristics and have added some detail to the report
on these issues. We examined beneficiaries covered by both Medicare
and Medicaid because detailed information on beneficiaries'
socioeconomic status is not available. We did not examine data on
beneficiaries without Medicare coverage because they are not included
in the data CMS used to develop the new bundled payment system. We
agree that Part D drugs will be important under the new bundled
payment system. However, data on the use of these drugs, which
according to CMS constituted about 14 percent of Medicare expenditures
on all ESRD drugs in 2007,[Footnote 88] were not available.
Second, industry representatives commented on our findings related to
beneficiaries' demographic characteristics and clinical conditions.
Representatives from KCC pointed out that our findings on the
relationship between Medicare expenditures on injectable ESRD drugs
and beneficiaries' demographic characteristics were consistent with
published research on this topic and noted that these relationships
are driven by underlying clinical factors. However, RPA
representatives noted that the report did not address the reason for
these observed relationships. In addition, representatives from KCC
and RPA agreed with our finding that clinicians do not take
beneficiaries' demographic characteristics into account when making
dosing decisions. However, KCC representatives noted that there was an
apparent disconnect between the results of our first and second
findings. In order to facilitate interpretation of these results, KCC
representatives suggested that we include in the report a copy of the
instrument used to collect information from clinicians and researchers
on the factors that are likely or not likely to result in above
average doses of injectable ESRD drugs.
We did not address the extent to which the relationships between
Medicare expenditures on injectable ESRD drugs and beneficiaries'
demographic characteristics were driven by underlying clinical factors
because doing so was beyond the scope of our study. We did, however,
obtain input from clinicians and ESRD researchers to gain insight into
the factors that may affect the dose of these drugs for dialysis
patients. We agree with KCC's suggestion and have included the
structured data collection instrument in appendix II.
Finally, representatives from all three organizations agreed that it
will be important to monitor the effects of the new bundled payment
system on beneficiaries but expressed concern about how CMS would
conduct such monitoring. Representatives from NRAA stressed the need
to identify vulnerable populations, such as those with high costs of
dialysis care, as part of the monitoring process. However, NRAA and
RPA representatives questioned how CMS would identify these
populations through its monitoring activities. In addition, KCC
representatives expressed concern about the timeliness of CMS's
monitoring activities, noting that data from CMS on the provision of
dialysis care can have a long lag time, which makes the information
less relevant. Representatives from all three organizations expressed
concerns related to CROWNWeb implementation. Specifically, both NRAA
and RPA representatives noted that they view CROWNWeb as a potentially
useful tool for CMS monitoring activities, but are concerned about
when it would be fully implemented. NRAA representatives noted that
challenges remain to making the database operational. Furthermore,
representatives from KCC cautioned that if data in CROWNWeb are not
collected in a consistent way across dialysis facilities, the
information from this database could be unreliable.
Our report recommends that CMS monitor the effect of the new payment
system on beneficiaries, such as those who are vulnerable to adverse
effects of the payment system because of their above average costs of
dialysis care. We also point out in the report that it will be
important for CMS to draw on data sources it has or is developing to
identify and monitor access to and quality of dialysis care for such
groups of beneficiaries. We agree with KCC representatives that CMS's
monitoring activities should be timely so that any problems resulting
from the new payment system can be addressed as soon as possible after
implementation. Our recommendation to CMS emphasizes the need for
timely monitoring, particularly given the sensitivity of the dialysis
population to potential disruptions in access to and quality of care.
We also reported that CROWNWeb is a key element in CMS's preliminary
plans for its monitoring approach, and agree that it is important for
CMS to develop reliable data and ensure that such data are available
to use as soon as possible after the bundled payment system is
implemented.
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 appropriate congressional committees and other
interested parties. The report will also be available at no charge on
the GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-7114 or cosgrovej@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 VI.
Signed by:
James C. Cosgrove:
Director, Health Care:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
Our objectives were to (1) provide information on Medicare
expenditures for injectable end-stage renal disease (ESRD) drugs, by
beneficiaries' demographic characteristics; (2) identify the factors
that clinicians and researchers indicate are likely to result in a
higher-than-average dose of injectable drugs for a dialysis patient;
(3) describe the Centers for Medicare & Medicaid Services' (CMS)
approach for addressing differences among beneficiaries in the cost of
dialysis care under the new bundled payment system for these services;
and (4) examine CMS's plans for monitoring the effects of the new
bundled payment system on beneficiaries.
To provide information on Medicare expenditures for injectable ESRD
drugs, by beneficiaries' demographic characteristics, we analyzed the
most recent available data from a national data system containing
information on beneficiaries with ESRD. Specifically, we obtained data
from the United States Renal Data System (USRDS) on monthly Medicare
expenditures per beneficiary on dialysis in 2007 for injectable ESRD
drugs.[Footnote 89],[Footnote 90] We focused our analysis on
erythropoiesis stimulating agents (ESA), intravenous (IV) iron, and IV
vitamin D because these three types of drugs accounted for about 98
percent of the approximately $2.2 billion in Medicare expenditures on
injectable ESRD drugs in 2007.[Footnote 91] We analyzed data for
326,899 Medicare beneficiaries on dialysis in 2007. The data we
analyzed did not contain all of the 413,540 beneficiaries on dialysis
in 2007 because we excluded beneficiaries (1) who were in Medicare
managed care plans, (2) for whom Medicare was not the primary payer,
or (3) for whom no claims for Medicare services provided in 2007 were
submitted.
We analyzed monthly Medicare expenditures per beneficiary in 2007 on
ESAs, IV iron, and IV vitamin D across the following demographic
characteristics available through the USRDS database: age, sex, race,
ethnicity, urban/rural residential location, and whether a beneficiary
was enrolled in Medicaid.[Footnote 92] Additionally, we analyzed USRDS
data for 2003 through 2006 to determine whether the results for 2007
were consistent in prior years. We did not address in our expenditure
analysis the extent to which the relationships we presented between
demographic characteristics and Medicare expenditures reflected
underlying clinical or other factors. Data on monthly Medicare
expenditures per beneficiary were based on Medicare claims. The
expenditure amounts that we presented did not include beneficiary cost
sharing. Monthly Medicare expenditures per beneficiary were calculated
by dividing Medicare expenditures for a given drug by the number of
months beneficiaries were on dialysis in 2007.
USRDS data on demographic characteristics--with the exception of
Medicaid enrollment status--were drawn primarily from CMS's Renal
Management Information System (REMIS) database.[Footnote 93] Dialysis
providers collected these data using a standardized form called the
Medical Evidence Form.[Footnote 94] We used these data to present
results on monthly Medicare expenditures on injectable ESRD drugs
across the following age categories: 0-19, 20-44, 45-54, 55-64, 65-74,
and 75 and older. We selected these age categories to capture the
pediatric population (i.e., age 19 and under) and to make the number
of beneficiaries within each of the remaining categories similar. The
USRDS data we analyzed on race and ethnicity are based on subjective
determinations of beneficiaries' racial and ethnic identity. In
addition, these data were collected using different racial and ethnic
categories depending on which version of the Medical Evidence Form was
used. Figure 3 demonstrates how the racial and ethnic categories on
the different versions of the Medical Evidence Form link to the
categories we used in this report. A beneficiary's residence was
classified as urban if it was in an area with at least 500 people per
square mile, and all other areas were considered rural.[Footnote 95]
Finally, USRDS data on Medicaid enrollment status were drawn from the
Medicare Enrollment Database.[Footnote 96] We used beneficiaries'
Medicaid enrollment status as an indicator of their socioeconomic
status because beneficiaries' income and asset levels determine their
eligibility for Medicaid, which provides financial assistance with the
cost of medical care.[Footnote 97]
Figure 3: Crosswalk between Race and Ethnicity Categories on CMS
Medical Evidence Forms and the Categories Used in This Report:
[Refer to PDF for image: illustrated table]
Race in pre-1995 versions[A]:
White;
Black;
Asian or Pacific Islander;
American Indian/Alaskan Native;
Unknown.
Race in 1995 version[B]:
White;
Black;
Asian;
Pacific Islander;
American Indian/Alaskan Native;
Unknown;
Mid-East/Arabian;
Indian Subcontinent;
Other (specify).
Race in 2005 version[C]:
White;
Black or African American;
Asian;
Native Hawaiian or Other Pacific Islander;
American Indian/Alaskan Native;
Unknown;
Multiple races[C].
Race categories presented in report[D]:
White;
African American;
Asian or Pacific Islander;
American Indian/Alaskan Native;
Other/unknown.
Ethnicity in pre-1995 versions[A]:
Data on ethnicity not collected.
Ethnicity in 1995 version[B]:
Hispanic: Mexican;
Hispanic: Other;
Non-Hispanic;
Unknown.
Ethnicity in 2005 version[C]:
Hispanic or Latino;
Not Hispanic or Latino;
Unknown.
Ethnicity categories presented in report[D]:
Hispanic;
Not Hispanic;
Unknown.
Sources: CMS Medical Evidence Forms for pre-1995, 1995, and 2005.
Notes: About 4.0 percent of the 413,540 Medicare beneficiaries on
dialysis at some point in 2007 had race and ethnicity data in the
USRDS based on a pre-1995 version of the Medical Evidence Form, 45.5
percent had these data based on the 1995 version, 50.0 percent had
data based on the 2005 version, and 0.5 percent did not have data from
any version of the Medical Evidence Form.
[A] The pre-1995 versions of the form did not indicate that
beneficiaries could select multiple races and also did not collect
data on ethnicity.
[B] CMS required that dialysis providers use the 1995 version of the
Medical Evidence Form beginning on April 1, 1995. This version of the
form instructed beneficiaries to select a single race category.
However, the form did not specify whether beneficiaries should check
one or more ethnicity categories. In addition, the form did not have
an option for unknown ethnicity, so this category in the table above
refers to missing information for this characteristic.
[C] CMS required that dialysis providers use the 2005 version of the
Medical Evidence Form beginning on June 1, 2005. This version of the
form indicated that beneficiaries could select multiple race
categories. CMS noted in its 2009 proposed rule for the new bundled
payment system that while the form does not provide instructions for
whether to select multiple ethnicity categories, it is assumed that
the beneficiary would select one of the two categories. Medicare
Programs; End-Stage Renal Disease Prospective Payment System, 74 Fed.
Reg. at 49,222, 49,963 (proposed Sept. 29, 2009). In addition, the
form did not have options for unknown race or ethnicity, so these
categories in the table above refer to missing information for these
characteristics.
[D] See appendix III for detailed results by race and ethnicity on
monthly Medicare expenditures per beneficiary on injectable ESRD drugs.
[End of figure]
We assessed the reliability of data from the USRDS by interviewing
officials responsible for producing these data, reviewing relevant
documentation, comparing the results to published sources, and
examining the data for obvious errors. Although we report that CMS has
concerns about using data on race and ethnicity for the purposes of
adjusting bundled payments, we determined that data on these
characteristics as well as other USRDS data that we used were
sufficiently reliable for the descriptive analytical purposes of our
study.
To identify the factors that clinicians and researchers indicate are
likely to result in a higher-than-average dose of injectable ESRD
drugs (specifically, ESAs, IV iron, and IV vitamin D) for a dialysis
patient, we developed a structured data collection approach that
included interviews with relevant industry groups, clinicians, and
researchers with expertise in ESRD as well as the administration of a
Web-based data collection instrument to selected nephrology clinicians
and ESRD researchers (see appendix II for the data collection
instrument). To develop this instrument and provide context for our
findings, we conducted 20 structured interviews with representatives
of large and small dialysis organizations and dialysis-related
professional organizations, nephrology clinicians, and researchers
with expertise in ESRD and also reviewed the clinical literature
related to the use of the three types of drugs.[Footnote 98],[Footnote
99] We asked each interviewee about the beneficiary characteristics
associated with high or low use of these drugs. We summarized the
information obtained from these interviews and used it to develop the
lists of clinical factors used for our data collection instrument. The
demographic factors listed on the data collection instrument were
those we examined in our analysis of Medicare expenditures on
injectable ESRD drugs. We pretested the data collection instrument
with nephrologists and revised it based on comments we received.
Through the data collection instrument, clinicians and researchers
were asked to identify the clinical and demographic factors that are
likely to result in a higher-than-average dose of ESAs, IV iron, or IV
vitamin D for a dialysis patient. In addition, individuals who
completed the data collection instrument had the option of writing in
factors not already listed in the instrument. We analyzed results by
calculating the percentage of the 73 clinicians and researchers who
completed our data collection instrument who identified a given factor
as being likely or not likely to result in a higher-than-average dose
of each of the three types of ESRD drugs we examined. These results
represent the views of the 73 clinicians and researchers and are not
generalizable to a broader population.
We administered the Web-based data collection instrument to a select
number of clinicians and researchers with expertise related to the
factors that could impact the dose of injectable ESRD drugs. We
selected these individuals in two ways. First, we obtained referrals
from national, U.S.-based professional organizations that represent
nephrology clinicians (i.e., nephrologists, nephrology nurses,
nephrology physician assistants, and advanced practitioners
specializing in nephrology) who evaluate and treat dialysis patients.
[Footnote 100] We compiled an initial list of nephrology-related
professional societies and associations based on our background
research on ESRD.[Footnote 101] To identify additional organizations,
we visited the Web site of each of these organizations and obtained a
list of related organizations, if available. We selected eight
organizations from these lists that met the above criteria. We asked
each organization that we identified for referrals to up to 20
nephrology clinicians who have expertise related to factors that could
impact the dose of ESAs, IV iron, or IV vitamin D for dialysis
patients. We specified in our request that these individuals must (1)
be nephrologists, nephrology nurses, physician assistants or advanced
practitioners specializing in nephrology, or nephrology technicians/
technologists; (2) evaluate and treat dialysis patients; and (3)
reside in the United States. We also asked for referrals to major
national societies or associations, other than the ones we already
planned to contact, that are based in the United States and represent
nephrology clinicians. If referrals to additional organizations were
provided, we contacted these groups as described above and asked them
for referrals to clinicians. We received referrals from the following
seven organizations[Footnote 102]:
* American Academy of Nephrology Physicians Assistants:
* American Nephrology Nurses' Association:
* American Society of Nephrology:
* American Society of Pediatric Nephrology:
* Council of Advanced Practitioners[Footnote 103]
* Renal Physicians Association:
* Women in Nephrology:
The second way we identified clinicians and researchers was through
the ESRD literature. Using multiple databases, including BIOSIS
Previews®, Elsevier BIOBASE, MEDLINE, SciSearch®, EMBASE®, EMCare, and
EMBASE AlertTM, we conducted a review of the literature published from
2004 through 2009 related to the use of ESAs, IV iron, and IV vitamin
D to treat ESRD patients.[Footnote 104] We searched these databases
for articles related to the dose of these drugs.[Footnote 105]
We administered the Web-based data collection instrument in August and
September 2009. We sent the instrument to 131 clinicians and
researchers--the 100 referrals we received from professional
organizations and an additional 31 primary authors that we identified
through the literature. We received 73 completed instruments.
To describe CMS's approach for addressing differences among
beneficiaries in the cost of dialysis care under the new bundled
payment system for these services, we reviewed CMS's proposed rule on
the design of the new payment system.[Footnote 106] We also reviewed
the Department of Health and Human Services' report to Congress on the
design of the new payment system as well as reports on this topic by
the University of Michigan, Kidney Epidemiology and Cost Center (UM-
KECC), which has assisted CMS with the payment system's design.
[Footnote 107] In addition, we interviewed CMS officials and
representatives from UM-KECC. We also interviewed representatives of
three non-Medicare payers of dialysis care--the Department of Veterans
Affairs (VA) and two large health plans--to obtain contextual
information about other bundled payment systems.[Footnote 108],
[Footnote 109] Finally, to examine CMS's plans for monitoring the
effects of the new bundled payment system on beneficiaries' access to
and quality of dialysis care, we interviewed CMS officials and
reviewed prior reports as well as CMS's proposed rule on the design of
the new bundled payment system.
[End of section]
Appendix II: GAO Data Collection Instrument on Dose of Dialysis-
Related Drugs:
GAO Questionnaire on the Dose of Dialysis-Related Drugs:
U.S. Government Accountability Office:
Purpose of the Questionnaire:
The U.S. Government Accountability Office (GAO), the research arm of
Congress, has been asked by the Chairman of U.S. House of
Representatives, Committee on Ways and Means, Subcommittee on Health
to study the treatment of Medicare beneficiaries with end-stage renal
disease (ESRD). As part of this work we are collecting expert opinion
on the factors that are likely to result in a higher than average dose
of dialysis-related drugs used for a dialysis patient.
Below is a brief questionnaire that we arc using to systematically
collect information from experts on the factors that are likely to
result in a higher than average dose of injectable vitamin D,
injectable iron, and erythropoietin stimulating agents (ESAs) used for
a dialysis patient. Your response to this questionnaire is
particularly important given that we arc sending it to a select group
of experts. We developed the list of potential factors in the tables
below based on interviews with individuals who have expertise in this
area. We realize that there are many demands on your time and greatly
appreciate your response to this questionnaire, which should take
about 15 minutes.
Completion Date:
Please complete the questionnaire within 2 weeks.
How to Get Help:
See 'how to get help' if you have questions or arc experiencing
difficulties responding to the questionnaire.
Navigation Instructions:
We have provided navigation instructions to help you complete the
questionnaire, answer questions and edit answers, exit and re-enter
the questionnaire, and print your responses.
Factors that Are Likely to Result in a Higher than Average Dose of
Injectable Vitamin D, Injectable Iron, and ESAs:
Injectable Vitamin D:
For each factor listed below, please indicate whether it is likely or
unlikely to result in a higher than average dose of injectable vitamin
D for a dialysis patient.
Hyperparathyroidism:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Malnutrition:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Lack of Pre-dialysis care:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 0-19:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 20-44:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 45-54:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 55-64:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 65-74:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Age: 75+:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Sex: Female:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Sex: Male:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Race: African American:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Race: White:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Race: Other:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Ethnicity: Hispanic:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Ethnicity: Non-Hispanic:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Residential Location: Urban:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Residential Location: Rural:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Socioeconomic Status: Low:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Socioeconomic Status: High:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Please specify any factors not listed above that are likely to result
in a higher than average dose of injectable vitamin D for a dialysis
patient:
Injectable Iron:
For each factor listed below, please indicate whether it is likely or
unlikely to result in a higher than average dose of injectable iron
for a dialysis patient.
Large Body Size:
Likely to Result in a Higher than Average Dose:
Not Likely to Result in a Higher than Average Dose:
Do Not Know:
Low iron stores (e.g. transferrin saturation
