Download Proposed Revision in the Current Hemoglobin Metric:

Service to those affected by chronic kidney disease
Lori Hartwell
Founder/President
Malia Langen
Chairman of the Board
Susan Vogel, RN
Treasurer
Linda Oakford
Secretary
Board Members:
Sara Carlson, RD, CDE
Dale Davis
Marlene DeCenzo
Stephen Furst
Jacki Harris, RN
Lori Hartwell
Maria Hsieh
Michael Josbena
Lana Kacherova, RN
Robert Klein
Malia Langen
Linda Oakford
Wendy Rodgers
James Troyer
Susan Vogel, RN
August 26, 2011
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1577-P
P.O. Box 8010
Baltimore, MD 21244-8010
Reference: Changes to the End-Stage Renal Disease Prospective Payment
System for CY 2012 End Stage Renal Disease Quality Improvement Program
for PY 2013 and 2014
I am writing as the Founder and President of the Renal Support Network (RSN).
Our patient-focused, patient-run organization is dedicated to helping improve
outcomes for patients with kidney disease. Our patient members who require
dialysis or a transplant to live have reviewed the proposed changes in the Quality
Incentive Program (QIP) in detail, and have raised a number of issues and concerns
that we would like you to consider prior to finalizing future QIP metrics.
Proposed Revision in the Current Hemoglobin Metric:
The Centers for Medicare & Medicaid Services (CMS) has proposed to retire the
hemoglobin <10 g/dL measure beginning with the 2013 ESRD QIP. The proposed
change does not include any requirement for monitoring trends in the percent of
patients with hemoglobin < 10 g/dL. It also does not provide a disincentive for
dialysis facilities that are “outliers”, as indicated by either a higher percentage of
patients with hemoglobin <10 g/dL, or a significantly lower average hemoglobin
level compared with national or regional averages.
This proposal has generated concerns among patients regarding the potential
negative impact on patient quality of life, quality of care, and our ability to receive
a successful kidney transplant. We as patients understand the very real impact of
lower hemoglobin levels on our ability to function. We realize that the Food and
Drug Administration has rejected as inconclusive study data assessing the effect of
higher hemoglobin levels ranging levels >12 g/dL on quality of life either because
the data were not reported directly by patients or because the instrument used to
collect the data was not validated. However, we can definitely state that the anemia
symptoms are real and that they can negatively affect both our quality of life and
our ability to participate in daily activities. When erythropoietin-stimulating agent
(ESA) therapy was first introduced in the late 1980s, many of the symptoms that
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had previously been attributed to uremia were found to be caused by anemia—and these symptoms
disappeared when anemia was treated properly. As someone who has been living with kidney disease
since before ESAs were available, I can personally attest to the devastation that accompanies low
hemoglobin levels, and to the fact that I am transformed into a happy and productive member of
society when my hemoglobin level is right for me. My experience has been verified by virtually all
patients who remember the “bad old days” when ESAs were not available to treat anemia.
Importantly, lower hemoglobin levels <10g/dL are also associated with an increase in red blood cell
transfusions. Data have shown that blood transfusions, in turn, result in an increase in panel reactive
antibodies (PRA), which limit patients’ ability to receive a kidney transplant. Many patients with high
PRA levels die before they ever receive a successful transplant. We are very concerned that lower
hemoglobin levels may result in more red blood cell transfusions, putting patients at risk for never
receiving a kidney transplant.
Experience has shown that payment drives clinical practice. Even before the new prescribing
information for ESAs was developed, the convergence of the clinical trial results that led to these
changes and the prospective payment system (PPS) had already generated a significant, and clinically
appropriate, decrease in the percentage of patients with high hemoglobin levels. The only true
protection to ensure that the pendulum did not swing too far in the other direction was the QIP policy
that provided a financial disincentive for facilities that maintained too many patients at hemoglobin
levels below 10 g/dL. The current CMS proposal would eliminate that safety net and de-emphasize the
importance of anemia management.
Many of RSN’s members are long-term dialysis patients who have experienced the unintended
negative effects of policy changes on our quality of care. Our patient members have offered the
following observations and predictions regarding how this current proposal could negatively affect our
care and quality of life:
1. More patients will feel the ill effects of anemia and have difficulty with activities of daily living,
especially employment.
2. The FDA term “to avoid transfusion” implies that patients will always be on the brink of
needing one unless some standard is established.
3. If hemoglobin is kept at an undetermined minimum value and the level drops because of
infection, hospitalization, or other comorbidities, the result can be a dramatic increase in the
number of patients who have severe anemia and require a blood transfusion.
4. Patients are concerned that consistency of care could suffer because there is no agreement
among clinicians about when to administer a blood transfusion, or a minimal hemoglobin level
sufficient to avoid a transfusion.
5. Patients wonder how they can be protected if they know they function better when their
hemoglobin is 10.5 g/dL and the facility or doctor wants the level to be 9 g/dL?
6. Consistency of care will quickly erode, and each dialysis facility or clinical practice will
establish its own parameters for hemoglobin targets, potentially holding ESA doses and
increasing the number of transfusions of red blood cells.
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7. Mean hemoglobin levels will decrease to <10 g/dL. As a result, there will be a significant
increase in the number of patients with levels below <9, <8, and <7 g/dL, and a corresponding
increase in blood transfusions (a circumstance that the new FDA prescribing information is
attempting to prevent).
8. There will be increased variability in hemoglobin levels (another circumstance that the new
prescribing information is attempting to prevent) as clinicians continually hold or dramatically
decrease ESA doses in an attempt to maintain the hemoglobin level in a narrow range.
9. Greater use of blood transfusions will lead to more patients with high panel reactive antibody
(PRA) levels and more patients for whom kidney transplantation is difficult, delayed, or
impossible.
10. More blood transfusions put patients on dialysis at particular risk for new types of infections
that are not currently screened.
11. An increase in blood transfusions will place an unnecessary burden on the nation’s blood
supply and impact other patients.
Although we are not medical experts, we believe that we are the experts in how effective the therapies
that we receive are in allowing us to live our lives. Something such as an appropriate hemoglobin
level, that may seem trivial to an individual without our disease, can make the difference between
living a happy and productive life, or living a life in constant misery. Therefore, from the patient’s
perspective, it is not appropriate to retire the hemoglobin <10 g/dL metric from the QIP entirely and
hope that appropriate anemia management will be provided to all patients. By the time one or more of
the potential negative ramifications that patients have predicted (see the listing in the following
section) are detected, it will be too late.
At Renal Support Network, we are fond of the saying that “an illness is too demanding if you don’t
have hope.” We hope that the clinicians, politicians, and regulators who are involved in making a
decision on the QIP metrics consider the issues outlined in this letter and the recommendations we
outline below:
Recommendations for the Hemoglobin <10 g/dL Metric:
1. CMS should leave the hemoglobin <10 g/dL metric in the QIP as a reporting measure for all
patients, regardless of whether they are receiving ESA therapy or not. Consider leaving the
hemoglobin <10 g/dL as a metric, but remove the financial penalty and have it monitored and
enforced similarly to the old clinical performance measure metric. (If necessary CMS could
assign a very minimal financial weighting level to the hemoglobin <10 g/dL metric to
emphasize the importance of maintaining appropriate hemoglobin levels.)
2. We understand that some have raised a concern about a hemoglobin <10 g/dL metric due to
statutory reasons. We do not completely understand the rationale for this concern since under
the old prescribing information guidance the target hemoglobin of 10 to 12 g/dL was commonly
not achieved without apparent statutory ramifications. However, if this is a realistic concern
and the hemoglobin levels <10 g/dL cannot be included in QIP as a reporting measure, then
there is a need for timely public reporting to collect current data on the percent of patients with
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hemoglobin levels <10, <9, <8, <7 g/dL to ensure that patients are not adversely affected.
Importantly, devise a plan ahead of time that can be implemented immediately if adverse effects
are noted.
3. If this reporting measure cannot be legally added to the QIP measure, CMS should consider
alternative sources of data and ensure timely public reporting (within six months) to include
the posting of a certificate with comparative outcomes at dialysis facilities to keep patients
informed.
4. Continue to include the <10 g/dL hemoglobin measure in Dialysis Facility Compare, and
improve the timeliness of data reporting.
5. CMS should continue to monitor and enforce metrics that protect patients, such as
transfusions, hospitalizations due to anemia, quality of life, increase in patients with higher
PRA levels who are listed for transplantation, and inappropriate underutilization of ESAs.
Consider how to collect these data in real time so that patient outcomes do not suffer for a
prolonged period of time before corrections can be enacted.
6. As soon as one of these newer measures of how anemia is being managed can be practically
assessed, it should be immediately added to the QIP as a payment measure.
Other Proposed Clinical Measures:
RSN would like to provide the patient’s perspective on other proposed clinical measures, including
Kt/V, vascular access, rates of infection, and the standardized hospitalization ratio, as follows.
Dialysis Adequacy Measured Through Kt/V Method
CMS has long acknowledged that Kt/V is superior to URR for measuring dialysis adequacy, and we
applaud the transition in the QIP from URR to Kt/V.
However, Kt/V does not accurately reflect the status of patients doing short daily, more frequent or
nocturnal treatments, so adjustments should be made accordingly. We are also informed by the
professional community that there is variability in reporting of Kt/V based on the
formula/methodology used, or the laboratory that is performing the evaluation. In addition, we
recommend that the adequacy of dialysis be appropriately monitored for all home-based dialysis
therapies.
Currently, many patients are minimally dialyzed with a traditional regimen and are simply receiving
enough treatment to survive, but not live well. The problem is that Kt/V and URR measures are
minimally sufficient and patients therefore can meet the dialysis adequacy measure and still not feel
well. The goal of a good adequacy measure should eradicate all symptoms and signs of uremia and
fully rehabilitate the patient.
Recommendation: CMS should adopt Kt/V as a measure of dialysis adequacy until a better one that is
widely recognized as a more accurate measure of whether dialysis cleanses blood effectively is
developed and adopted by the community. In addition, there should be a standardized way of
calculating Kt/V, an understanding that minimal levels may not be optimal levels, and a method for
assessing adequacy across all modalities.
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Percent of Patients Receiving Treatment Through an Arteriovenous (AV) Fistula
A dialysis access is the lifeline for ESRD patients who receive hemodialysis, and an AV fistula is the
gold standard for improved patient outcomes. Fistulas need time to mature before they can be used,
and patients may require a venous catheter for dialysis. In addition, CMS should recognize that not all
patients have the vascular structure to mature a fistula, and those patients should be monitored to
ensure that they receive a synthetic graft instead of a catheter whenever possible.
Recommendation: CMS should continue to encourage and track the percentage of the use of AV
fistulas, but modify the QIP metric to encourage the use of fistulas or grafts instead of a catheter.
Rates of Infection of the Vascular Access Site
Infection-related death is the second most common cause of death after cardiovascular events, and this
is a critically important measure to put in place for continuous quality improvement. Catheters are the
primary source of infections, and with proper incentives dialysis facilities will work to improve
infection control and educate patients on access care.
In addition, the bundled payment system includes the cost of Activase™ which can unclog a catheter
of fibrin sheaths, or clots that have occluded it. Activase™ is a costly medication, and CMS should
consider monitoring to see whether this drug is being used less frequently and whether catheter
intervention hospital admissions are increasing.
Recommendation: CMS should measure catheter access site infections and make this a performance
measure to provide an incentive for dialysis facilities to have patients get a fistula (when appropriate)
or a graft to reduce catheter access-related infection. In the future, CMS should consider monitoring
whether Activase™ is being used less frequently, thereby resulting in more catheter surgeries or
interventions.
Standardized Hospitalization Ratio (SHR) Admissions Measure
Hospitalizations are a very important issue to patients, but we do not understand how the information
will be tracked since patients have multiple comorbidities that the facility can control in only a limited
way and that may result in hospitalization. Also, we do not want there to be a disincentive to
hospitalizing patients that may result in untimely or inappropriate care. Since cardiovascular disease is
the number one cause of patient mortality, CMS should consider monitoring congestive heart failure
admissions arising from fluid overload. CMS should consider monitoring for hospitalizations
specifically for red blood cell transfusions.
Recommendation: CMS should not include the SHR admission rate as a QIP measure at this time.
CMS should consider monitoring congestive heart failure admissions to address one of the primary
issues of fluid management identified by the Technical Expert Panel, and also monitor for
hospitalizations that are for red blood cell transfusions.
Monitoring Phosphorus and Calcium Levels Every Month
With the proposed incorporation of phosphate binders and calcimimetics in the PPS slated to take
effect in 2014, it is critical that bone and mineral management have robust metrics in place to protect
patients from any reimbursement-driven changes in appropriate clinical practice, and allow them to
access medications that will positively affect their health. In the meantime, monitoring phosphorus and
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calcium levels will provide valuable information as we move to a new payment system that may have
adverse outcomes on patients’ quality of care.
Recommendation: RSN supports CMS’s proposal in requiring facilities to monitor phosphorous and
calcium levels every month.
Other Future Measures
RSN is pleased that CMS is considering the measurement of serum calcium concentration, serum
phosphorous concentration and assessment of iron stores. In addition, RSN suggests albumin,
immunization, bone and mineral metabolism, and fluid management as possible QIP metrics.
Proposed Reporting Measures:
RSN would like to provide the patient’s perspective on the proposed reporting measures, as follows.
National Health Safety Network (NHSN) Dialysis Event Reporting Measure
We support the education of dialysis professionals, but do not know what kind of training, outcomes
assessment, and time that will be required to fulfill the proposed event reporting mandate. Dialysis
staff time is very valuable, and we do not want it diverted from patient care to an activity where the
outcome is not clearly defined.
Recommendation: RSN supports the public reporting of ESRD adverse events, but does not
understand what will be reported and what kind of training will be provided. This needs to be clearly
defined before moving forward on this initiative.
Patient Experience of Care Reporting Measure
The Consumer Assessment of HealthCare Provider and Systems (CAHPS) survey is definitely a step in
the right direction to help capture the patient experience on a yearly basis.
The one critical area that the survey does not address is the plethora of experiences during the survey
period. These experiences can run the gamut of care, and the CAHPS survey may not capture the
essence of what the patient is experiencing in terms of individual dialysis treatments or their general
experience while on dialysis. Patients may also perceive the survey as onerous as it contains 52
questions and is administered by a third party organization which is unknown to the patient.
CMS should consider adopting a process measure to ensure that the patient has a voice during each
dialysis treatment. RSN suggests that a real-time process measure be put in place to understand how
patients perceive each dialysis treatment, and what their experience of that treatment is. For example,
after each treatment the patient should be asked whether it was good or bad. If the latter, additional
information on access problems, low blood pressure, crashing, cramping or other pertinent indicators
reflecting the patient’s experience could be evaluated. Collecting this information will help providers
understand why patients do not stay for the entire treatment or why they miss treatments. It will
become clear to the physician and facility manager that the patient is not tolerating their treatment
well, and that adjustments should be made proactively.
Recommendation: RSN supports the CAHPS survey reporting measure to CMS. Also, CMS should
consider an additional process measure that assesses the patient’s experience during individual
treatments.
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Other Issues:
RSN would like to provide the patient’s perspective on the following additional issues.
Update the Training Add-On
Training for home dialysis is critically important to patients. In the past, training programs have not
been adjusted for inflation, which has resulted in a decline in home training programs and access for
people who seek this treatment option. To ensure patients have access to proper training and qualified
staff, it is essential that CMS correct this payment issue to ensure access to quality home training.
Recommendation: CMS should update the training add-on to keep pace with inflation and allow
facilities to provide quality home training for their patients
Establishing a New Technology Adjustor
A new technology adjustor that incentivizes innovations in care is vitally important for patients with
ESRD. Innovation in dialysis care can result in more convenient and more effective care for dialysis
patients. New medications, diagnostic approaches, and medical options offer the hope of better
treatment that can potentially result in more efficient and cost effective care, increased life expectancy,
and improvement in the patient’s quality of care and life.
Recommendation: CMS should include a technology adjustor to ensure innovation in the dialysis
program.
From the patient’s perspective, the provision of quality care that meets or exceeds expected standards
and guidelines is the single most important factor contributing to a full and productive life. Patients can
tell you how we feel—both before and during our dialysis treatments—and most of us convey this
information to our healthcare team to help them improve our quality of care. Kidney disease is a
complex illness, and dialysis requires a delicate balance between treatment parameters and individual
patient status.
The delay or potential abandonment of CROWNWeb makes dialysis patients vulnerable since there is
no mechanism for the timely monitoring as the PPS is being implemented. Timely monitoring of the
implementation of the PPS should be a top priority for CMS.
We thank you for the opportunity to add the patient’s voice to your considerations on quality measures.
Sincerely,
Lori Hartwell
President & Founder
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