[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
                       HEARING ON ENSURING KIDNEY 
                       PATIENTS RECEIVE SAFE AND 
                   APPROPRIATE ANEMIA MANAGEMENT CARE 

=======================================================================

                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                     U.S. HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 26, 2007

                               __________

                           Serial No. 110-51

                               __________

         Printed for the use of the Committee on Ways and Means

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                      COMMITTEE ON WAYS AND MEANS

                 CHARLES B. RANGEL, New York, Chairman

FORTNEY PETE STARK, California       JIM MCCRERY, Louisiana
SANDER M. LEVIN, Michigan            WALLY HERGER, California
JIM MCDERMOTT, Washington            DAVE CAMP, Michigan
JOHN LEWIS, Georgia                  JIM RAMSTAD, Minnesota
RICHARD E. NEAL, Massachusetts       SAM JOHNSON, Texas
MICHAEL R. MCNULTY, New York         PHIL ENGLISH, Pennsylvania
JOHN S. TANNER, Tennessee            JERRY WELLER, Illinois
XAVIER BECERRA, California           KENNY HULSHOF, Missouri
LLOYD DOGGETT, Texas                 RON LEWIS, Kentucky
EARL POMEROY, North Dakota           KEVIN BRADY, Texas
STEPHANIE TUBBS JONES, Ohio          THOMAS M. REYNOLDS, New York
MIKE THOMPSON, California            PAUL RYAN, Wisconsin
JOHN B. LARSON, Connecticut          ERIC CANTOR, Virginia
RAHM EMANUEL, Illinois               JOHN LINDER, Georgia
EARL BLUMENAUER, Oregon              DEVIN NUNES, California
RON KIND, Wisconsin                  PAT TIBERI, Ohio
BILL PASCRELL, JR., New Jersey       JON PORTER, Nevada
SHELLEY BERKLEY, Nevada
JOSEPH CROWLEY, New York
CHRIS VAN HOLLEN, Maryland
KENDRICK MEEK, Florida
ALLYSON Y. SCHWARTZ, Pennsylvania
ARTUR DAVIS, Alabama

             Janice Mays, Chief Counsel and Staff Director

                  Brett Loper, Minority Staff Director

                                 ______

                         SUBCOMMITTEE ON HEALTH

                FORTNEY PETE STARK, California, Chairman

LLOYD DOGGETT, Texas                 DAVE CAMP, Michigan
MIKE THOMPSON, California            SAM JOHNSON, Texas
RAHM EMANUEL, Illinois               JIM RAMSTAD, Minnesota
XAVIER BECERRA, California           PHIL ENGLISH, Pennsylvania
EARL POMEROY, North Dakota           KENNY HULSHOF, Missouri
STEPHANIE TUBBS JONES, Ohio
RON KIND, Wisconsin

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Ways and Means are also published 
in electronic form. The printed hearing record remains the official 
version. Because electronic submissions are used to prepare both 
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unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
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                            C O N T E N T S

                               Page______

                                                                   Page

                               WITNESSES

Hon. Donna M. Christian-Christensen, M.D., a Delegate to Congress 
  from the United States Virgin Islands..........................    55

                                 ______

Leslie V. Norwalk, Acting Administrator, Centers for Medicare and 
  Medicaid Services..............................................    68
Robert A. Vito, Regional Inspector General for the Office of 
  Evaluation and Inspections, U.S. Department of Health and Human 
  Services, Philadelphia, Pennsylvania...........................    85
John K. Jenkins, M.D., Director, Office of New Drugs, Center for 
  Drug Evaluation and Research, Food and Drug Administration, 
  Rockville, Maryland............................................    94

                                 ______

Ajay K. Singh, M.D., Clinical Director, Renal Division, Director, 
  Dialysis Services, Associate Professor of Medicine, Brigham and 
  Women's Hospital, Boston, Massachusetts........................   133
Kris Robinson, Executive Director and CEO, American Association 
  of Kidney Patients, Tampa, Florida.............................   138
Alan S. Kliger, M.D., President, Renal Physicians Association, 
  Rockville, Maryland............................................   143

                       SUBMISSIONS FOR THE RECORD

Amgen, statement.................................................   155
Kidney Care Partners, statement..................................   163
National Renal Administrators Association, statement.............   166
Renal Support Network, statement.................................   169
Research Utilization Project Proposal, statement.................   171


                       HEARING ON ENSURING KIDNEY
                       PATIENTS RECEIVE SAFE AND
                  APPROPRIATE ANEMIA MANAGEMENT CARE

                              ----------                              


                         Tuesday, June 26, 2007

             U.S. House of Representatives,
                       Committee on Ways and Means,
                                    Subcommittee on Health,
                                                   Washington, D.C.

    The Subcommittee met, pursuant to call, at 10:05 a.m., in 
Room 1102, Longworth House Office Building, Hon. Fortney Pete 
Stark (Chairman of the Subcommittee) presiding.
    [The advisory announcing the hearing follows:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                         SUBCOMMITTEE ON HEALTH

                                              CONTACT: (202) 225&093943
FOR IMMEDIATE RELEASE
June 26, 2007
HL-15

                 Stark Announces a Hearing on Ensuring

                    Kidney Patients Receive Safe and

                   Appropriate Anemia Management Care

    House Ways and Means Health Subcommittee Chairman Pete Stark (D-CA) 
announced today that the Subcommittee on Health will hold a public 
hearing on safety concerns regarding the dosing of erythropoiesis 
stimulating agents (ESAs), variations in utilization of ESAs across 
providers, and reimbursement issues. The hearing will take place at 10 
a.m. on Tuesday, June 26, 2007, in Room 1100, Longworth House Office 
Building.
      
    In view of the limited time available to hear witnesses, oral 
testimony at this hearing will be from the invited witness only. 
However, any individual or organization not scheduled for an oral 
appearance may submit a written statement for consideration by the 
Committee and for inclusion in the printed record of the hearing.
      

BACKGROUND:

      
    The Medicare program began covering treatment for patients with End 
Stage Renal Disease (ESRD) beginning in 1972. According to the U.S. 
Renal Data System (USRDS), the dialysis population reached nearly 
336,000 patients in 2004 at a cost of $20.1 billion. This amounts to a 
57 percent increase in Medicare ESRD spending since 1999. In 2004, the 
average annual cost per Medicare beneficiary was $58,000.
      
    When a patient's kidneys stop working, as is the case with ESRD 
patients, they often cannot produce enough of the hormone 
erythropoietin, which helps the body produce red blood cells. As a 
result, these patients suffer from anemia. Synthetic versions of 
erythropoietin are collectively referred to as erythropoiesis 
stimulating agents (ESAs), which are sold in the U.S. under the brand 
names of Epogen, Procrit, and Aranesp.
      
    Dialysis care has made great strides in treating anemia, and this 
achievement is directly linked to significant increases in doses of 
ESAs. Dosing levels increased dramatically in recent years, with 
average weekly dose of ESAs increasing nearly 4,000 units between 2000 
and 2004. Medicare spending for ESAs increased by 17 percent from 2003 
to 2004 alone, up to $1.8 billion. Spending on ESAs per person per 
month is now nearly one-half of the monthly cost for dialysis.
      
    While ESAs are critical to treatment of anemia for ESRD patients, 
higher doses that raise red blood cells above a certain threshold have 
been found to pose significant health risks to patients. The Food and 
Drug Administration (FDA) recently issued a black box label warning of 
risk of blood clots, strokes, heart failure and heart attacks in kidney 
patients in such circumstances. Furthermore, as both the Medicare 
Payment Advisory Commission and the Government Accountability Office 
point out, there are flaws in the current Medicare reimbursement 
system. The existing Medicare payment system incentivizes higher doses 
in certain circumstances, with resulting health risks and higher costs 
for beneficiaries and taxpayers.
      
    ``My priority for Medicare ESRD policy is to ensure patient safety 
while also protecting taxpayers from unnecessary expenditures,'' stated 
Chairman Stark in announcing the hearing. ``Health risks associated 
with higher doses and well-documented flaws in a payment system that 
encourages higher dosing highlights that this issue is ripe for 
reexamination. We must do better for our ESRD beneficiaries and for the 
taxpayers.''
      

FOCUS OF THE HEARING:

      
    The hearing will focus on the safety concerns regarding dosing of 
ESAs for ESRD, variations in utilization of ESAs across providers, and 
issues related to reimbursement.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

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    Chairman STARK. Good morning. We'll begin our hearing on 
ensuring that kidney patients receive safe and appropriate 
anemia management care.
    Delegate Christian-Christensen, acting administrator 
Norwalk, Dr. Jenkins, Mr. Vito and the advocates and 
researchers on our third panel, I want to thank you for being 
here today. My hope is that we won't be interrupted by too many 
votes so that we can proceed and not keep you here all day.
    Ms. Norwalk, I believe it will be her last scheduled 
appearance before the Ways and Means Committee in her current 
position, and I want to wish her luck in whatever her future 
endeavors may be and to thank Ms. Norwalk for her service at 
CMS.
    As you know, the issue of Medicare's care for end-stage 
renal disease, ESRD, patients was one where our former chairman 
Bill Thomas and I were in agreement. We're here today to 
advance the discussion of safety issues and the problems with 
the current reimbursement system that Chairman Thomas raised in 
our last hearing in December.
    In 2005, there were 321,000 Medicare beneficiaries 
receiving dialysis. We spent 8 billion on their dialysis and 
drugs including the anti-anemia drug Epogen. From '91 to 2004, 
Medicare spending on Epogen for ESRD patients grew from $245 
million to $2 billion, an increase of over 700 percent.
    We fully recognize that Epogen and other drugs like it, 
known collectively as ESAs, are critical to the treatment of 
anemia for ESRD patients. No one disputes the underlying 
benefit of this therapy for people suffering from anemia, 
however there are two major concerns regarding the use of 
ESA's.
    First, we must put patient safety first. We'll hear from 
the FDA that when anti-anemia drugs are used to raise red blood 
cell levels above a certain threshold there's a risk of death, 
blood clots, strokes, heart failure and heart attacks. We need 
to keep this in mind as we're dealing with populations that are 
more vulnerable to these conditions.
    Second, we're stewards of taxpayers' dollars. The current 
Medicare reimbursement system creates incentives for higher 
dosing of ESAs, which lead not only to the aforementioned 
health risks, but also come at a higher cost to taxpayers and 
beneficiaries.
    The Office of the Inspector General will present their new 
report, released today, documenting that large dialysis 
organizations make a profit on each and every dose of Epogen. 
Recent research published in JAMA shows that for-profit 
dialysis centers dose Epogen at higher levels than not-for-
profit centers. The payment system leads to perverse incentives 
that we cannot ignore.
    I would say that the opposite is true. If we reduce the 
payment we might have incentive for providers to cut the level 
of ESAs and thereby have people's levels dropped to a dangerous 
level on the minus side.
    I did hear this morning that Amgen is releasing some 
numbers today as a part of an industry public relations stunt. 
And if Amgen and the rest of the industry are finally admitting 
that there are health safety concerns and lowering Epogen 
dosing accordingly, I'm glad to hear it.
    This announcement proves however that there are additional 
efficiencies that can be gained by reducing Epogen doses. 
Clearly what I've been saying all along is true. The industry 
only responds when we threaten to do the right thing and remove 
their incentive to inflate doses as a way to reap profits. 
Medicare can be a better purchaser of care for dialysis 
beneficiaries and can do so in a way that ensures more 
efficient use of ESAs and better health outcomes for 
beneficiaries.
    I'd like to quote from a few letters that I've recently 
received and will set the stage for what we'll talk about 
today. Without objection, the letters will be entered into the 
record in their entirety.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Letter from the National Institutes of Health, ``Between 
1991 and 2005, the average weekly dose of Epo more than 
doubled. Furthermore, NIH data show that in 2005 over half of 
the dialysis patients had hemoglobin levels above twelve grams 
per deciliter,'' I guess it is, ``or greater.''
    Keep in mind that the FDA recommends that hemoglobin levels 
not exceed 12 yet NIH data show that more than half of the 
patients are at 12 or higher.
    The GAO writes that Medicare could realize greater system 
efficiency if all ESRD drugs and services were bundled under a 
single payment system.
    The Medicare Payment Advisory Commission writes, ``A 
bundled rate would create incentives for providers to furnish 
services more efficiently and would remove the financial 
incentive for facilities to overuse dialysis drugs. Bundled 
payments would encourage more efficient use of ESAs.''
    Please note here that we must, without question, and it 
should be of paramount importance that we are sensitive to 
patient-specific variations in the need for ESAs when we 
structure a bundled payment system. We are not recommending a 
one-size-fits-all system here.
    The two large, for-profit chains have standardized dosing 
protocols and often they will encourage doctors to sign kind of 
a uniform dosing agreement without taking into effect the tests 
that should be done periodically during the course of 
treatment. We can address these sensitivities with steps such 
as aggressive monitoring and quality programs.
    I'm sorry that CMS is unable to deliver their long overdue 
report on ESRD bundling. This report was due more than two-and-
a-half years ago, and at our hearing on this topic last 
December CMS promised to report by summer of 2007. Guess what? 
For those of you who've been outside today, summer is here.
    I understand that CMS will give us some insight on that 
report today. I look forward to that testimony and receiving a 
commitment from CMS as to when we'll receive the report.
    Lastly, both Kaiser Permanente of southern California and 
the Veterans Administration have written letters to discuss 
their practice patterns. Each is able to safely and effectively 
treat patients with doses of up to 30 percent lower in Epo than 
we see used in Medicare. And I might add that Kaiser contracts 
with one of the for-profit chains to provide this service so 
that in effect they are paying a bundled rate to one of the 
for-profit operators and they are setting some standards such 
as ``subcuetaneous'' administrating of the drugs as does the VA 
and they are getting a one-third smaller dosage of ESAs in 
these programs.
    Seventy-six percent of VA patients receive ESAs in this 
way, ``subcuetaneous'', and they have annual savings between 
$3,000 and 4,000 per patient. Now presuming that they buy Epo 
on the Federal schedule, they're probably paying half of what 
the for-profit chains are paying and you might then say that we 
could save from $6,000 to 8,000 per patient if we in fact 
followed the VA's protocol or Kaiser.
    Kaiser in southern California does administer ESAs 
``subcuetaneous'' and confirms that doing so requires a dose 30 
percent smaller than needed for intravenous use. Of even 
greater interest, they do use bundled payments and write that 
bundled payments are an efficient way to pay dialysis centers 
and are consistent with both positive health outcomes for 
beneficiaries and the efficient use of Epogen. They do suggest 
that they monitor it closely and they can feel comfortable with 
the results.
    We must be certain that Medicare payments are structured to 
ensure the highest quality care to all beneficiaries, and I am 
confident that we can do so for dialysis services in a more 
efficient manner that safeguards against health risks of 
targeting the higher red blood cell levels. This should be the 
committee's goal for Medicare ESRD patients.
    Now if there's anything left to say, Mr. Camp can say it.
    Mr. CAMP. I'm sure I can find something.
    Well, thank you, Mr. STARK. I also want to thank all of the 
witnesses from the three panels for being here today and also a 
special thanks to Leslie Norwalk, the acting administrator of 
CMS for her excellent and informative testimony before the 
Committee.
    I appreciate you calling this hearing today. I agree that 
the safety of dialysis treatments is critically important. 
Coupled with the fact that 320,000 Medicare beneficiaries 
receive dialysis treatments, at a cost to taxpayers of 7.9 
billion, this is a significant financial issue as well. Given 
the spread of diabetes and related conditions like kidney 
disease, these numbers are regrettably only going to increase.
    We are all aware of the disturbing reports that have been 
published, which highlight how the current Medicare payment 
system may create incentives for providers to dose patients 
with unnecessarily higher levels of the drugs used to treat 
anemia in dialysis patients. This is alarming given the serious 
health concerns associated with the overuse of these same 
drugs.
    In fact, the Food and Drug Administration recently released 
a ``black boxed warning'' that indicates an increased risk of 
death from blood clots, strokes and heart attacks in kidney 
patients and tumor growth in cancer patients from aggressive 
dosing of these drugs called ESAs.
    In response to these events, policymakers have begun to 
consider proposals to reform the current Medicare payment 
system for dialysis. MedPAC has recommended bundling ESRD drugs 
into the larger payment rate.
    As we consider making significant changes to how Medicare 
pays for dialysis I want to sound a note of caution. ESRD 
patients are a very sick population, often suffering from 
multiple chronic conditions, who may not benefit from a one-
size-fits-all approach to this issue.
    Any type of bundled payment must provide a proper 
adjustment to account for sicker patients. An appropriate 
bundled payment also needs to account for small dialysis 
facilities in rural areas, which have higher costs and may not 
be able to achieve the same efficiencies as the larger national 
dialysis providers.
    In order to ensure that Medicare beneficiaries continue to 
receive access to high quality kidney care, we must also 
support adequate reimbursement to dialysis facilities. We need 
to maintain adequate payments to these providers, so that they 
can maintain their focus on prevention and care management of 
dialysis patients.
    To address these issues, I introduced the Kidney Care 
Quality and Education Act of 2007. This bill provides a 3-year 
update to the composite rate and rewards dialysis providers for 
quality improvement and attainment. Both the quality initiative 
and payment update have been continually recommended by MedPAC.
    Through increased awareness and education on chronic kidney 
disease, both the patient and the provider can take steps to 
slow the progression and prevent the need for dialysis in the 
future. I have worked closely with the kidney care community to 
comprehensively address these issues, and I feel that it is 
important that Congress move forward. I certainly look forward 
to working with Chairman Stark to maintain quality care for 
kidney patients.
    Thank you, and I yield back the remainder of my time.
    Chairman STARK. Would the gentleman yield?
    Mr. CAMP. Yes.
    Chairman STARK. And perhaps we could stipulate something 
here at the beginning.
    I don't think that either of us would suggest or that 
Chairman Thomas suggested or anybody else has suggested that we 
have a one-size-fits-all. I think we could stipulate that most 
medical treatment professionals would suggest that these are 
unique treatments for unique individuals and they vary, and 
that there are monitoring tests so you could tell fairly 
quickly how well they are doing, and that I don't think anybody 
on this Committee or I don't think any of the witnesses would 
suggest that we should just have a blanket treatment schedule.
    And I just wanted--I don't know if that comes up in any of 
these----
    Mr. CAMP. Well, that's very reassuring. Reading all the 
testimony yesterday I just thought it was important to put that 
out, and I think it's very----
    Chairman STARK. I'm glad you did, but I think that you'd 
find----
    Mr. CAMP. It's hard to know when you read the testimony 
exactly how they're going to come forward today, but I think 
it's very reassuring that we can both agree to that.
    Chairman STARK. Is there anybody else who has a burning 
opening statement that can't appear in the record? And if not, 
I'm happy to recognize the Honorable Donna M. Christian-
Christensen, a physician, a delegate to Congress from the 
United States Virgin Islands.
    Donna, why don't you try and, in layman's language, educate 
us as best you can? Although we limit to 5 minutes, you'll have 
5 minutes in the subsequent questioning to expand upon anything 
you'd like to tell us.
    Ms. TUBBS JONES. Mr. Chairman, if you will, allow me, just 
a moment. For the record, I'd like to make it clear that Donna 
Christian-Christensen Chairs the Congressional Black Caucus 
Health Brain Trust and she's been doing that for a number of 
years. And she's experienced many years in Congress doing the 
work, and I just wanted to recognize the work of Dr. 
Christensen.
    Chairman STARK. I thank the gentlelady for her comments.

  STATEMENT OF MRS. CHRISTENSEN, CONGRESSIONAL DELEGATE, U.S. 
                         VIRGIN ISLANDS

    Mrs. CHRISTENSEN. Thank you, Mr. Chairman, Ranking Member 
and Members of the Committee. Thank you, Congresswoman Tubbs 
Jones, for those generous comments. And I really welcome the 
opportunity to testify this morning.
    I have my submitted testimony and I'm really going to speak 
from notes from that and from having a chance to have looked at 
some of the testimony that's submitted.
    At the outset, I want to just start out by agreeing with 
you, Mr. Stark, that our priority is to ensure patient safety 
while also protecting taxpayers from unnecessary expenditures. 
And I also want to just agree with Ms. Norwalk who says in her 
testimony that the development of a new payment system is a 
significant endeavor that merits careful consideration and 
analysis.
    And there's also other areas of the testimony that I really 
agree with, which is the need for reviewing the EMP and 
reimbursement and collaboration with the entire renal care 
community and the need for treatment decisions to be made by 
the patient and his or her physician. It's not the facilities 
that make those decisions. It's the patient and their doctor in 
consultation with each other.
    And also on the advisory for the hearing there were certain 
facts that I want to just reference because I want to make sure 
that we're speaking from the same facts, and I stand to be 
corrected if I'm wrong, but first it was stated that ESAs 
account for about--almost 50 percent, and it's my understanding 
they account for 25 percent of ESRD costs.
    Second, on the studies that raise the concerns that brought 
us here today and to reviewing the EMP, they were done in 
chronic renal disease patients not end-stage renal disease 
patients, and I think FDA will point out that they were done in 
conditions, for conditions not recommended on the prior labels 
and not treated for targets that are recommended. They were 
treated for higher targets of over 13 and over 14, so they 
really don't represent what happens in everyday chronic disease 
or end-stage renal disease practice.
    And third, I don't think it's really been established that 
current CMS payment system incentivizes higher dosing. In fact, 
even Ms. Norwalk says in her testimony that it encourages 
really that all services that are needed be provided. And the 
only downside that she offers for the present system is that it 
may make providers more complacent and not willing to seek out 
innovative and new ways to provide more efficient treatment, 
but I doubt that. As a physician I know we're always looking 
for better, more effective ways to take care of our patients, 
which brings me to why I felt it was important for me.
    I want to talk from the perspective of two groups, one, of 
course, and I am chair of the Health Brain Trust. We are 
finalizing our position on this issue, but this is where we are 
at this point. And we're speaking on behalf of the 32 percent 
of the ESRD patients who are African Americans and the other 
people of color who are disproportionately suffering from end-
stage renal disease.
    Although African Americans for example are 13 percent of 
the U.S. population we are 38 percent of all patients treated 
for end-stage renal disease and we reach that point at younger 
ages. We are very disproportionately impacted by diabetes and 
hypertension as well, and we have higher risks when we have 
diabetes and hypertension to develop chronic renal disease and 
end-stage renal disease.
    African Americans have an incidence that's more than three 
times that of whites, Native Americans--about two times that of 
whites and Hispanic Americans, 1.5, and that's by 2002 data. So 
whatever adverse consequences might occur, they would 
disproportionately impact people of color.
    And I brought a couple of maps. The minority quality forum 
prepares maps really looking at renal disease--do you have 
them, these maps--across communities, and the lines, the ones 
with the lines across are those that have high minority 
populations.
    And both, if we look at Congressman Stark and another 
Member of the Committee, Mr. McCrery's maps, you'll find that 
although, Mr. Stark, you have some green areas, which are sort 
of medium incidence rates, in some of your areas where you have 
high minority populations, those are mainly where you have high 
Asian populations who are--while they are slightly above the 
white population for ESRD, they are not as heavily impacted as 
African-American populations. And some of your highest end-
stage renal disease incidences are in San Leandro and Hayward, 
where it appears by our looking at it that you have your 
highest African-American populations.
    And in Mr. McCrery's, they have a mixed picture, but some 
of the areas where they have higher minority populations they 
also have higher incidences of ESRD patients. I'm not sure if 
I--do you have Mr. Camp's as well? Mr. Camp's is almost more 
green than anything else, and your population is 88 or better 
percent Caucasian and you have some of the lower rates of end-
stage renal disease.
    Those just go to underscore what I've been saying. And we 
can get other maps for other districts if you'd like, but I 
think across the board they're going to show that higher ESRD 
incidences exist in communities of color, and particularly 
where you have high population percentages of African 
Americans.
    I'm also a family physician with more than 20 years of 
practice experience and I've been a hospital administrator with 
some degree of oversight, not a lot, but some degree of 
oversight for our dialysis unit. And I want to say on behalf of 
my fellow physicians, we went into this profession because we 
care about people. We care about their health and their overall 
well-being. So our greatest incentive is to have what we do 
result in a healthier individual, a healthier family. But we 
also have to keep our offices open in order to be able to do 
that.
    The kind of strict and narrow EMP being considered not only 
ignores our years of study and dedication and our expertise as 
physicians but it also has the potential to tie our hands so as 
to cause us to under treat, not only in renal disease but even 
in some cancer patients so that we end up with hemoglobin below 
11. We years ago, very wisely, put a lot of time and 
deliberation and moved away from that when we found that 
hemoglobins under 11 cause far more morbidity and mortality 
than this current study that we're referencing suggests and the 
black box insinuates.
    As a matter of fact, as I look at the block box, I think 
that in the first instance suggesting that they, ESAs, be used 
just to a level that would prevent transfusion is very 
shortsighted and ignores other benefits that are important to 
treat anemia as well as it adds risks that providers trying to 
treat just to the transfusion would tend to under treat and 
would end up with those hemoglobins 11 or under.
    And I think it's a bit misleading because it doesn't 
clearly state that the untoward effects that occurred under 
higher than normally used dose regimens in targeting toward 
higher hemoglobin than is the current practice.
    And the last thing I wanted to underscore about physicians 
is that they haven't had the commensurate increases in 
reimbursement compared to the increasing costs of care. So to 
now bundle the payments beyond what is now being done is to put 
them further behind the curve and really challenged to meet 
their overhead and perhaps to close.
    And we note that in cases where dialysis facilities closed, 
those that closed, by and large treated higher percentages of 
African-American patients, so again we are mostly impacted.
    On the incentive issue I think as I look at it, rather than 
incentivize for more Epogen as the current Erythropoietin 
protocols state, if they're targeted to meet the hemoglobin of 
between 11 and 12, which is the current practice, if they go 
over--CMS already decentivizes treating physicians from going 
over because they reduce your payment. There's a disincentive 
already present in the current EMP to overtreating patients, 
and I think that should suffice.
    And again, I just want to underscore that we are here to 
heal, to do good and not to do any harm. And I think that's 
what we ought to also be focused on as we look at a new EMP, to 
do no harm.
    I want to just end by--and I'm going to read from my 
prepared statement. I know, Chairman and Members, that as the 
cost of the healthcare continues to skyrocket the temptation is 
to do something quickly, and the easiest and quickest approach 
is to cut costs, but that's the kind of knee-jerk reaction that 
is not really worthy of this institution. More importantly it 
runs the very real and high risk of hurting patients. And 
because such large proportions of those patients with end-stage 
renal disease are African Americans we again will be the ones 
more adversely impacted by the decisions made without careful 
study of all the clinical implications.
    We went through this in 1997 and we should take heed to the 
lessons learned back then. I would hope--and the CDC and all of 
our partnering organizations, universities and advocacy groups 
are working to this end, that we could get you, our colleagues 
and leaders on the issues of healthcare to see that the only 
way to cut costs is to emphasize prevention and increase the 
portion of the health budget dedicated to that and also to 
eliminate the disparities in health, a major one of which is 
end-stage renal disease, that cause people of color to seek 
care that is often uncompensated at late stages of their 
disease.
    And that is really the only way that we can cut healthcare 
costs in the long run. Cost containment runs a real risk of 
creating an unjust, inequitable and ineffective system of 
healthcare in this country where some Americans, usually 
those--African-Americans and other people of color are left 
behind or left out, period.
    And I want to thank the chairman again for holding this 
hearing and the Ranking Member, and I look forward to answering 
questions either from my written testimony or from my comments, 
from my notes. Thank you.
    [The prepared statement of Mrs. Christensen follows:]
  Statement of The Honorable Donna M. Christian-Christensen, M.D., a 
       Delegate to Congress from the United States Virgin Islands

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman STARK. Thank you. Mr. Camp, would you like to----
    Mr. CAMP. Thank you, Mr. Chairman.
    Thank you very much for your testimony. Your written 
testimony has a lot of information in it that I think will be 
very helpful to the Subcommittee.
    You correctly point out that African-Americans constitute 
38 percent of dialysis patients in this country. And the 
complexity of finding a proper formula to account for 
differences in patient population is a difficult one. It's a 
complex issue. If CMS were to bundle ESRD drugs with a 
composite rate or make some other formula change how best can 
we do that in a way that does not result in poor outcomes, 
particularly for the entire patient mix, but for the vulnerable 
patient populations you testified about?
    Mrs. CHRISTENSEN. I'm not sure that I have all the answers 
to that specifically right now, but there are a lot of people 
studying it. But there have been some suggestions that we 
either bundle everything and treat ESAs differently because of 
their importance to renal dialysis, which is something we all 
agreed to in one way or another. Either we include them with 
some specific issues addressed about their--the need for more 
individual titration or we exclude them from the bundle and put 
some other kind of cost-containment measure, a cap maybe, on 
the cost or change the cap on the costs or the amount that can 
be used per month or that we excluded entirely.
    But I don't have the final answer on that. But there are 
many suggestions out there that I think we need to look at 
because Epogen and Procrit and the other ESAs are so critical 
to not only preventing transfusions but allowing patients to 
live a decent quality of life while on dialysis.
    Mr. CAMP. Thank you, and thank you for your leadership on 
this and other health issues in the Black Caucus and in the 
Congress. I've enjoyed working with you on a number of issues 
and look forward to working with you on this as well. Thank you 
very much.
    Mrs. CHRISTENSEN. Same here. Thank you.
    Mr. CAMP. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Thompson.
    Mr. THOMPSON. Yes, thank you very much for testifying. I 
too share many of your concerns, look forward to working with 
you as the Subcommittee takes this issue on.
    Chairman STARK. Mr. Johnson.
    Mr. JOHNSON. No questions.
    Chairman STARK. Mr. Becerra.
    Mr. BECERRA. Mrs. Christensen, thank you very much for your 
testimony. I'd like you to just give us a little bit more 
information on what you think we can do on any number of these 
issues that it appears that because we lack some of the data 
which could give us a better sense of some of the different 
populations and the outcomes and effects that some of these 
different populations will experience, whether it's with drugs 
or treatment, what we can do to try to address those 
disparities that occur in the healthcare field right now that 
make it very difficult for us to assess populations within the 
U.S. or part of the American fabric because we have not yet 
reached out to all of these populations whether African 
American, Latino or otherwise.
    I'm wondering what you can tell us in terms of what we are 
missing in terms of better legislating to make sure that the 
disparities are addressed.
    Mrs. CHRISTENSEN. Thank you for that question, and we'll 
have a very specific answer for you probably later this week as 
the tri-caucus, the congressional black, Hispanic and Asian-
Pacific caucuses introduce our minority health legislation, 
which addresses issues around language proficiency and making 
sure that those services are not only paid for but that we 
understand what is supposed to be done and the certification 
for those who will be doing the translation, better data 
collection.
    The health professions issue is a big one, and reaching out 
to communities of color who are now under-represented in the 
healthcare profession workforce and finding ways to incentivize 
them and help them to get into those professions because it's 
been shown that--not only that people of color are 
discriminated against either when they get into the healthcare 
system but, in the converse, that when they are treated by 
people of the same cultural and linguistic background where 
they can develop a greater rapport--and that patient-doctor 
relationship is critically important, that they get better 
compliance and therefore better outcomes.
    So we have a number of issues that we're going to address 
there, but you know, we're operating under some budgetary 
constraints and I just don't think that we can do it without an 
investment that starts to bring people up to at least a level 
playingfield in terms of where health status is. And you know, 
I would urge everyone to consider making that investment 
because we're paying for it on the other end, when you go to 
emergency rooms and seek care that is very expensive, you get 
there at late stages of the disease and the treatment costs 
more, and it's not being paid for--and of course, bringing 
everyone under coverage, because minorities make up more than 
half of the uninsured population in this country.
    Mr. BECERRA. And your testimony points out that when we 
don't have that information at hand, when we haven't gone out 
there to try to solicit the full participation of some of these 
groups, populations, that we end up paying because we're not 
sure how to best administer, whether it's drugs or the 
therapies that are out there and we may make mistakes that 
actually cost people their lives. So I think you're absolutely 
right, and I hope that when the tri-caucus does come out with 
this information Congress takes it very seriously. So thank you 
very much.
    Mrs. CHRISTENSEN. Thank you. And our message is to really 
proceed with caution. I think everyone wants to rein in costs, 
and I think everyone wants to make sure, obviously, that 
patients are taken care of safely and properly, but we want to 
make sure that we have all of the information that we need to 
make the best decision for everybody.
    Mr. BECERRA. Excellent. Mr. Chairman, thank you very much. 
I yield back.
    Chairman STARK. Ms. Tubbs Jones.
    Ms. TUBBS JONES. Mr. Chairman, thank you very much. And Dr. 
Christensen, Congresswoman Christensen, thank you so much for 
coming this morning to present this testimony.
    For the record, my sister died from kidney failure, my 
cousin is on dialysis right now, a lot of people in my family, 
and the issue becomes very personal for me, more than just on 
behalf of my constituency. Tell me, just so we have this in the 
record, it may be in writing, the proposed bundling puts in 
place--let me ask it like that. What will proposed bundling do 
to impact the physician's ability to prescribe or oversee his 
client's health?
    Mrs. CHRISTENSEN. It depends on how it's done and whether 
there's any flexibility. And with some of the medications, you 
know, part of Medicare, part of ESRD payments are bundled now 
and part is not, and you might include some more and leave some 
out and may change--you may just want to change it from a 60/40 
to an 80/20 with 80 percent being bundled.
    But what it does is, depending on how--what the 
reimbursement is, if the reimbursement is too low, physicians 
may have to make choices that they ought not to have to make in 
terms of whether to prescribe Epogen or Procrit or the other 
ESAs as needed to have that patient achieve a better quality of 
life and to target their hemoglobin where we know that ought to 
be, and realizing that African Americans, obese patients and 
other patients require higher doses of Epogen. So you have to 
take all of that into consideration.
    They may not have the ability to adjust to the different 
needs of different patients if the bundle is too tightly 
reimbursed. And that will harm patients, and it will likely 
harm those who are most dependent on end-stage renal disease 
treatment.
    Ms. TUBBS JONES. And I think we've said this before, that 
sometimes a proposal that on its face appears neutral in its 
implementation it has a disparate impact.
    Mrs. CHRISTENSEN. Oh yes.
    Ms. TUBBS JONES. And so what you're saying to us as a 
Committee is that before you make your decision on this, 
understand the impact that could have and the disproportionate 
impact it could have on minority communities.
    Mrs. CHRISTENSEN. And include everybody that has a stake in 
the decisionmaking process, whether it's the patients, the 
dialysis facilities, even those who provide the medication and 
the physicians of course, the treaters.
    Ms. TUBBS JONES. And are you hearing that everybody is not 
having opportunity to be at the table to have that discussion?
    Mrs. CHRISTENSEN. In looking through some of the reports or 
testimonies or white papers by patient groups, physician groups 
and other groups, that's the point that's most often made.
    Ms. TUBBS JONES. Okay. Again, Dr. Christensen, thank you so 
much for coming this morning to testify. I believe your 
testimony has been eye-opening for us, the Committee as we make 
our decisions. And know that I'll call on you again sometime. 
Thanks.
    Mrs. CHRISTENSEN. Thank you.
    Chairman STARK. Thank you. Dr. Christensen, the best 
procedure, I believe, would be to treat each dialysis patient 
as a unique patient. There's no indication that anyone--that 
there's a certain amount for any racial group or any age group 
or for smokers or non-smokers; that's up to, I presume, the 
physician's determination and the tests which would show the 
levels of their anemia or their blood count. Is that correct, 
so there is a unique measure for each patient as to how well 
they're doing?
    Mrs. CHRISTENSEN. Yes, but I think studies have shown 
already that certain groups require more of certain 
medications.
    Chairman STARK. But you're not proposing that we do this on 
a group basis, are you? You're proposing that we continue to 
have each individual patient measured. Wouldn't you agree that 
that's the best way to do it?
    Mrs. CHRISTENSEN. Sure.
    Chairman STARK. So that whether we are concerned with 
overutilization taking us above 12 if that's the agreed on 
upper level or below 11 if that's the agreed on lower level, we 
wouldn't want to create a payment system that takes us either 
too low or too high. Is that a fair----
    Mrs. CHRISTENSEN. I think that's fair, and I think that the 
current EMP does that successfully now.
    Chairman STARK. And we can measure that, can we not, and 
should measure it, I believe, as a patient goes through 
dialysis--and that there are other factors, I believe, such as 
do you do it--how often and how long? In other words, do you do 
it once a week for 5 hours or do you do it five times a week 
for 1 hour?
    I don't pretend to understand but there are differences 
just in the dialysis protocol not to mention the--or whether 
you do it ``subcut'' or intravenous. All of these things can 
affect, as I understand it, the level of the person's blood 
level, whatever we call that.
    Mrs. CHRISTENSEN. Right.
    Chairman STARK. Okay. Is that a fair understanding?
    Mrs. CHRISTENSEN. Yes, as well as certain disease events, 
if they develop infection or if they have some concurrent 
disease going on.
    Chairman STARK. So would you agree that, as long as we can 
build in to the requirements for dialysis a monitoring program, 
a quality program that is current for each patient we would be 
doing the best job of ensuring that they get the proper 
treatment. Is that----
    Mrs. CHRISTENSEN. As long as that monitoring is done over a 
long enough period of time to see the ups and downs that 
normally occur, because at any given time you may check a 
hemoglobin and it may be 13, but in the next few weeks it will 
be back down.
    So there are fluctuations that occur that are totally 
acceptable and do not indicate that the person is being 
overtreated. And as long as the period of time of monitoring is 
long enough to encompass all of that, I would say yes.
    Chairman STARK. And that should be in the judgment of the 
physician, should it not?
    Mrs. CHRISTENSEN. Yes, the decision when to treat, how to 
treat and at what----
    Chairman STARK. Yes. Well, I don't know as we have any 
disagreement, and I want to thank you for your testimony. I 
appreciate your concern. Thank you very much.
    Mrs. CHRISTENSEN. Thank you very much.
    Chairman STARK. Our next panel will consist of the acting 
administrator for CMS, Ms. Leslie Norwalk; Mr. Robert A. Vito, 
the regional inspector general for the Office of Evaluation and 
Inspection of the U.S. Department of Health and Human Services; 
Dr. John K. Jenkins, the director, the Office of New Drugs, 
Center for Drug Evaluation and Research, the FDA, from 
Rockville, Maryland.
    I want to welcome the panelists and at least from the 
chairman's point of view if not the staff ask the panelists--in 
addition to Ms. Norwalk to please talk to us in layman's 
language and if they're Latin words say them slowly, and if 
they're big numbers, wait until I get my shoes and socks off.
    And Ms. Norwalk, would you like to proceed to enlighten us 
in any way you're comfortable?
    Without objection, by the way, all of your prepared 
testimony will appear in the record in its entirety.

 STATEMENT OF LESLIE V. NORWALK, ACTING ADMINISTRATOR CENTERS 
               FOR MEDICARE AND MEDICAID SERVICES

    Ms. NORWALK. Thank you Chairman Stark, Representative Camp 
and the rest of the distinguished Members of the Committee. And 
I'd also like to thank you in particular for your kind words 
about my service. I appreciate it.
    Medicare spends more than $8 billion annually on dialysis 
and dialysis-related drugs. Of this, 25 percent is spent on 
erythropoietin stimulating agents or ESAs. My testimony focuses 
on payment for the treatment of approximately 400,000 Medicare 
beneficiaries with end-stage renal disease.
    CMS has dedicated a considerable amount of time and 
resources to researching the development of a prospective 
payment system or PPS for ESRD that bundles payment for 
services and dialysis as well as for drugs and lab tests, most 
of which are now paid separately.
    Shortly we will release a report to Congress on the 
elements and features of such a payment system for ESRD. Today 
I want to highlight some of the major design issues in an ESRD 
bundled payment system and also talk about the use of ESAs.
    In contrast to our current system, which pays separately 
for drugs and encourages their use, a bundled PPS would focus 
on appropriate delivery of the full range of ESRD services. 
Such a PPS would change the incentives for ESA use, potentially 
eliminating their overpromotion and overdosing and could 
obviate the need for a specific monitoring policy targeting ESA 
utilization, and with a collection of measures facilitate a 
broader focus on quality.
    An ESRD bundled PPS would establish a fixed payment amount 
for a set of services furnished to a patient in an ESRD 
facility. The PPS would give facilities flexibility of managing 
ESRD patient care and eliminate incentives that have led to the 
overutilization of some medications.
    As with any PPS, facilities could retain the difference if 
costs were less than the Medicare payment and would be liable 
for the difference in cost if costs were greater than Medicare 
payment. Our research has focused on the following, the unit of 
payment per treatment or per month, case mix adjustment, a 
geographic adjustment, other payment adjustments such as 
outliers, special and technical design issues such as payment 
for home dialysis, setting and updating initial rates, quality, 
operational and administrative issues and the effective dates.
    A key design issue in any payment system is a case mix 
adjustment that reflects the variation in resources for 
different kinds of patients. To date, our research indicates 
several case mix adjustment factors can be used in addition to 
the three used in the current system. Specifically, in addition 
to age, body surface area and low body mass index other factors 
could include duration of renal replacement therapy, co-morbid 
conditions and gender.
    For example, the base payment amount could be increased for 
patients who have been on renal therapy for less than 4 months 
because treatment of patients new to renal therapy involves 
substantially more resources. Our regression analyses have 
shown that an increase in payment of about 50 percent relative 
to standard, ongoing treatment would be appropriate in such 
cases.
    Similarly our research has found 12 co-morbid conditions 
for which payments should be increased to take into account the 
need for greater resources in treatment.
    Prospective payment systems involve setting initial payment 
rates that are often based on expenditures that would be 
projected to occur in the absence of such a system. In this 
case, questions have been raised about the current use of in 
pricing of ESAs. For example, the Inspector General has 
provided data on how drug acquisition costs of ESRD facilities 
compare to current Medicare payment rates. Thus, payment rates 
based on expenditures that incorporate recent use in pricing 
may be too high.
    Further, OIG studies on acquisition costs may guide us in 
this regard as we develop the payment system. In order to 
account for payment updates, CMS has researched an ESRD market 
basket for a bundled set of services. A market basket can be a 
starting point for determining an appropriate payment update 
mechanism since it is a measure of changes in input prices.
    However an update mechanism can also take into account 
other factors such as productivity changes or changes in 
efficiency. With ESRD, a bundled PPS could, for example, 
provide incentives to achieve cost-reducing efficiencies, 
including movement to subcutaneous administration of ESAs.
    In addition, the larger the bundle the PPS, the more 
opportunities there are to increase the efficiency of providing 
care. It is important to have a system for monitoring the 
quality of care so that providers furnish ESRD patients with 
appropriate services.
    Today many argue that the reimbursement rate for ESAs lead 
to overutilization. The economic incentives under a PPS are 
opposite. Consequently the PPS should include safeguards from 
underutilization. These include paying for the quality of care 
furnished to ESRD beneficiaries.
    CMS now has 18 quality measures for dialysis facilities 
covering several clinical areas, including hemodialysis and 
peritoneal adequacy, anemia management, vascular access and 
mineral metabolism as well as beneficiary satisfaction. The 
quality measures are based on the National Kidney Foundation 
Kidney Disease Outcome Quality Initiative or KDOQI clinical 
practice guidelines.
    One measure for anemia management recommends monitoring 
from adequate levels below 33 percent. We recognize that there 
is a delicate balance between low and high hematocrit levels, 
and monitoring for both under- and over-utilization is 
important.
    We have submitted these and other measures to the National 
Quality Forum for their endorsement, and they are scheduled to 
consider them by the end of the year. Our proposed rule on the 
conditions of coverage for ESRD facilities requires reporting 
on quality. A final rule is targeted for publication in early 
2008.
    If the proposal were finalized all ESRD facilities would be 
required to report the NQF endorsed measures for 100 percent of 
their patients. In order to minimize the reporting burden we 
are developing a web-based reporting system to begin in 
February of 2009, enabling us to assess quality for each 
facility.
    Until a bundled PPS changes incentives, effectively 
reducing overutilization of ESAs, we are taking action to 
strengthen our current ESA monitoring policy. Our current 
policy considers both hematocrit and dosage levels in order to 
promote appropriate administration.
    We are examining the impact of the policy implemented last 
year, specifically the percent of patients for whom the 
reported hematocrit exceeded 39 percent both before and after 
the policy went into effect. Our primary concern is for the 5 
percent of patients whose hematocrit levels are above 39 
percent for three or more consecutive months--they're 
persistently at 39 or above.
    Given the limited impact of our current policy, we are 
expanding our policy. Once implemented, CMS will reduce payment 
by 50 percent if a patient's hematocrit has exceeded 39 percent 
for three or more consecutive months. We will continue to 
review the impact that our monitoring policy has on ESA dosage 
and adjust accordingly.
    Finally, I'd like to briefly comment on the use of ESAs for 
non-renal care. As you know, the safety of our Medicare 
beneficiaries is paramount. Therefore, CMS plays close 
attention to FDA black boxed warnings.
    Following the meeting of the FDA's Oncology Drug Advisory 
Panel on May 14, CMS promptly opened a national coverage 
decision to assess whether there is sufficient evidence to 
conclude that ESA treatment is not reasonable and necessary for 
beneficiaries under certain circumstances related to cancer. We 
have received input from interested public parties on all sides 
of this issue, including the physician community, patient 
groups and manufacturers.
    The comment period for the national coverage decision 
closed on June 13. CMS and our physicians now are in the 
process of reviewing all of these comments. We will take them 
into account in developing a final national coverage decision, 
which is scheduled to be released in mid-August.
    In conclusion, CMS has made significant progress in 
researching how best to develop a bundled PPS for ESRD services 
and we continue to improve and refine our monitoring policy to 
promote appropriate ESA usage. We look forward to working with 
Congress on these critical issues. Thank you for your time this 
morning.
    [The prepared statement of Ms. Norwalk follows:]
   Statement of Leslie V. Norwalk, Acting Administrator, Centers for 
                     Medicare and Medicaid Services

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    Chairman STARK. Thank you.
    Mr. Vito.

STATEMENT OF ROBERT A. VITO, REGIONAL INSPECTOR GENERAL OFFICE 
 OF EVALUATION AND INSPECTIONS, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Mr. VITO. Good morning, Mr. Chairman and Members of the 
Subcommittee. I am Robert Vito, regional inspector general for 
the Office of Evaluation and Inspection at the U.S. Department 
of Health and Human Services Office of Inspector General.
    For nearly 20 years, the OIG has devoted considerable 
resources, attention to end-stage renal disease-related 
services. I appreciate the opportunity to appear before you 
today to discuss our most recent report released to you today 
on the pricing of separately billable end-stage renal disease 
drugs.
    The OIG work has involved ensuring the quality care of 
dialysis patients, conducting criminal and civil investigation 
of dialysis providers and examining pricing and utilization of 
dialysis-related drugs and services.
    For example, since June of 2000, OIG has issued six reports 
examining ways CMS can better monitor the quality of care in 
dialysis facilities. We have also assisted in settlement 
agreements with national dialysis providers regarding 
violations of the False Claim Act and other statutes.
    In addition, the OIG has been involved in pricing and 
utilization issues, including reviews in the early nineties of 
the end-stage renal disease composite rate and reimbursement 
for Epogen. In fact, in an October 1992 report we recommended 
that CMS consider including the cost of separately billable 
drugs into the composite rate to save on the administrative 
costs and to reduce payment errors.
    We also audited Epogen claims at dialysis facilities where 
we identified inconsistencies between the number of units of 
Epogen prescribed in the written order, administered by the 
facility and built to the Medicare Program.
    During this time period, the OIG issued a pricing report 
that found that the Department of Veterans' Affairs paid 
substantially less than Medicare for five high expenditure end-
stage renal disease drugs. Most recently, in response to 
mandates contained in the Medicare Prescription Drug 
Improvement and Modernization Act of 2003, the OIG conducted 
two studies on Medicare reimbursement for end-stage renal 
disease drugs.
    As required by the MMA, CMS used the data presented in the 
first report to set the 2005 reimbursement rate at freestanding 
facilities for ten high expenditure end-stage renal disease 
drugs. Reimbursement for drugs not included in our report was 
set at 106 percent of the ASP, the same method as the Part B 
drugs. At that time, hospital-based facilities were reimbursed 
at cost for most end-stage renal disease drugs.
    As of January 1, 2006, CMS set the reimbursement for all 
end-stage renal disease drugs with a few exceptions at 106 
percent of ASP. This change produced a consistent drug payment 
methodology among free-standing dialysis facilities and 
hospital-based dialysis facilities.
    These changes prompted the OIG to conduct an additional 
review of Medicare reimbursement for end-stage renal disease 
drugs. For this review, we obtained third quarter 2006 average 
acquisition costs for 11 high expenditure end-stage renal 
disease drugs from a sample of freestanding and hospital-based 
facilities and compared these costs to the Medicare 
reimbursement.
    Among the responding freestanding facilities, we found that 
the average acquisition cost for nine of the eleven drugs under 
review were below the Medicare reimbursement amount. The 
average acquisition costs for Epogen, a drug that accounts for 
three-quarters of the Medicare expenditures in freestanding 
facilities was 10 percent less than the Medicare reimbursement.
    Our analysis also showed that chain freestanding facilities 
paid less for drugs than non-chain facilities. On average, drug 
acquisition costs at the chain facilities were 12 percent below 
the Medicare reimbursement amount for the entire basket of end-
stage renal disease drugs compared to 7 percent below at the 
non-chain facilities. This difference can be attributed in 
large part to the pricing of Epogen as chain facilities receive 
larger discount rebates for the drug than non-chains.
    For hospital-based facilities we found the average 
acquisition cost for six of the eleven drugs under review were 
less than the Medicare reimbursement amount. For the remaining 
five drugs, acquisition costs were slightly above Medicare 
reimbursement. However, on the whole, the hospital-based 
facilities were not being under-reimbursed as the average 
acquisition cost for the entire basket of drugs were 7 percent 
below the Medicare reimbursement amount.
    In the hospital-based facilities, average acquisition costs 
for Aranesp and Epogen, the two drugs that account for the 
majority of Medicare spending in the hospital-based facilities 
were ten and 9 percent below the Medicare reimbursement amount 
respectively.
    In conclusion, as our body of work in this area shows, the 
OIG has been involved in end-stage renal disease-related topics 
for many years, helping to ensure that Medicare beneficiaries 
receive quality care and that the care is reimbursed at 
appropriate levels.
    CMS was able to use the results of our first mandated 
review to help set Medicare reimbursement amounts for 
separately billable drugs. We believe that our most recent 
study, a study not mandated by Congress, illustrates our 
commitment to continue providing current information on end-
stage renal disease issues to policymakers.
    This concludes my testimony, and I welcome your questions.
    [The prepared statement of Mr. Vito follows:]
Statement of Robert A. Vito, Regional Inspector General for the Office 
  of Evaluation and Inspections, U.S. Department of Health and Human 
                  Services, Philadelphia, Pennsylvania

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    Chairman STARK. Thank you.
    Dr. Jenkins.

 STATEMENT OF JOHN K. JENKINS, DIRECTOR, OFFICE OF NEW DRUGS, 
            CENTER FOR DRUG EVALUATION AND RESEARCH

    Mr. JENKINS. Good morning, Mr. Chairman and Members of the 
Committee. I am Dr. John Jenkins. I am the director of the 
Office of New Drugs at the Food and Drug Administration. Thank 
you for the opportunity to testify before you today about 
erythropoiesis-stimulating agents, which I will refer to as 
ESAs.
    ESAs are manmade versions of a natural human protein known 
as erythropoietin. Erythropoietin is made by the kidney and 
stimulates the bone marrow to produce red blood cells. The main 
goal of treatment with ESAs is to increase the number of red 
blood cells in patients with types of anemia that are 
responsive to ESAs in order to decrease the need for blood 
transfusions.
    The first ESA, Epoetin alfa was approved by FDA in 1989 for 
the treatment of anemia associated with chronic renal failure. 
Epoetin alfa is marketed under two trademarks, Epogen and 
Procrit.
    Since their initial approval, Epogen and Procrit have also 
been approved for use in patients with certain cancers, with 
anemia due to chemotherapy and patients with HIV infection with 
anemia due to certain anti-viral drugs and in patients 
scheduled for certain types of surgery to decrease a need for 
blood transfusions.
    The second ESA, Darbepoetin alfa, was approved by FDA in 
2001 for the treatment of anemia associated with chronic renal 
failure. Darbepoetin alfa is marketed under the trademark 
Aranesp. Aranesp was also approved by FDA in 2002 for the 
treatment of anemia caused by chemotherapy in patients with 
some types of cancer.
    Since the initial approval in 1989, the produce labeling 
for all marketed ESAs has been updated on several occasions to 
incorporate new safety information derived from clinical trials 
and from spontaneous reports of adverse reactions.
    The details of the major safety-related labeling changes 
for ESAs are in my written testimony and I will focus for now 
on briefly describing the most recent safety-related labeling 
change.
    The availability of extensive new safety information from 
clinical trials late in 2006 and early in 2007 prompted FDA to 
undertake a major revision of ESA labeling to include a boxed 
warning in March of 2007. As FDA became aware of the emerging 
safety information, we issued a series of public health 
advisories to alert healthcare providers and patients and to 
provide guidance on the use of ESAs.
    The first advisory, which was issued in November 2006, 
alerted healthcare professionals that a newly published 
clinical study, referred to as the CHOIR study, showed that 
patients with chronic renal failure not on dialysis who are 
treated with ESAs to achieve a higher target hemoglobin level 
had a significantly increased risk of serious and life-
threatening cardiovascular complications.
    The second advisory issued in February 2007 notified 
healthcare professionals of the results of a large clinical 
trial evaluating the use of ESAs to treat anemia in patients 
with cancer who were not receiving chemotherapy. In that study, 
patients treated with Aranesp had a higher death rate and no 
reduction in the need for transfusions compared to those 
treated with placebo.
    The most recent public health advisory, which was issued in 
March 2007, outlined new safety information from several newly 
reported trials. As I said earlier, in March 2007, FDA also 
approved revised labeling for all ESAs that included updated 
warnings and new boxed warning and modifications to the dosing 
instructions.
    The boxed warning advises physicians to use the lowest ESA 
dose that will gradually increase the hemoglobin level to a 
concentration sufficient to avoid the need for blood 
transfusions. The boxed warnings also highlight the major 
safety risks of ESAs in patients with renal failure and cancer.
    To further evaluate the newly available data in patients 
with cancer treated with ESAs, FDA convened its Oncologic Drugs 
Advisory Committee on May 10 of this year. The advisory 
Committee recommended that the results of all ongoing trials of 
ESAs in patients with cancer be submitted for FDA review as 
soon as the data were available, that additional trials be 
conducted by the sponsors to further evaluate the safety of the 
doses of FDA's recommended in the approved labeling and that 
FDA consider additional changes in product labeling to ensure 
the safe use of ESAs in patients with cancer.
    FDA is currently working with the sponsors of ESAs to 
address the advisory committee's recommendations. FDA is also 
planning discussion of ESA safety issues associated with the 
use in patients with chronic renal failure at a meeting of the 
Cardio-Renal Drugs Advisory Committee later this summer.
    In closing, let me state that FDA's mission is to promote 
and protect the public health. The major component of that 
mission is to ensure that the American public has access to 
safe and effective medical products and that healthcare 
providers and patients have updated information about the 
benefits and potential risk of approved drugs on which to base 
individual treatment decisions.
    FDA is continuing to carefully and thoroughly evaluate all 
available data for ESAs and will take additional regulatory 
actions in the future as warranted to ensure that the benefits 
of ESAs outweigh their risks when they are used according to 
the FDA-approved labeling.
    Thank you, and I'll be happy to respond to questions.
    [The prepared statement of Dr. Jenkins follows:]
  Statement of John K. Jenkins, M.D., Director, Office of New Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
                          Rockville, Maryland

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Chairman STARK. Thank you. Dr. Jenkins, is it FDA's 
position that Epogen, the dose of Epogen should be reduced by 
25 percent if the hemoglobin levels approach or exceed 12 
grams? Is that still where you are?
    Mr. JENKINS. That's the current dosing recommendations in 
the approved package labeling.
    Chairman STARK. And is there any reason that it should take 
three months to adjust a level that exceeds 12?
    Mr. JENKINS. Mr. Chairman, the ESAs take two to 4 weeks for 
each dose to have their effect on the bone marrow to raise the 
red blood cell count. So some of these drugs are administered 
as often as three times a week in patients who are on dialysis, 
so you can imagine that it's very difficult to carefully 
titrate the dose to achieve an exact hemoglobin level of 12. 
Plus, there are other factors of impact on the patient's 
hemoglobin level at any given time.
    So we recognize that there might be occasional excursions 
over 12, but our advice is to try to maintain hemoglobin at or 
below 12 as much as possible.
    Chairman STARK. Okay. Now DaVita's anemia management 
guidelines recommend a 25-percent increase in the dose if 
hemoglobin is near or at 12 grams, and they recommend a small 
decrease in the dose of 10 percent if it's between 12 and 13. 
And they recommend continued dosing up until a patient reaches 
a hemoglobin of 15. And it's only at the hemoglobin level of 15 
grams that they finally recommend to stop dosing.
    Now would that management guideline be consistent with the 
FDA's recommendations?
    Mr. JENKINS. Mr. Chairman, no, they would not. Our dosing 
recommendations recommend that you start reducing the dose of 
ESAs as you start to approach a hemoglobin level of 12, 
recognizing that you have to be very cautious in patients with 
end-stage renal disease about completely stopping the use of 
ESAs because they don't make much if any of their own 
erythropoietin. So sometimes stopping completely can lead to an 
undershooting of the hemoglobin and then you have to use higher 
doses of erythropoietin to get their bone marrow started again.
    So it's a careful titration but those recommendations you 
read would not be consistent with our approved labeling.
    Chairman STARK. And is it generally--you mentioned that 
people are dosed several times a week, and are they also tested 
several times a week so that the physician in charge can 
monitor these levels closely and should, as a matter of course, 
adjust the levels for each individual patient? Is that----
    Mr. JENKINS. That's true. The hemoglobin or hematocrit is a 
readily available laboratory test that can be measured 
frequently to help adjust the dose of erythropoietin.
    Chairman STARK. Well, then my question to Ms. Norwalk is, 
while I appreciate CMS being Johnny-on-the-spot, why did you go 
to a 13 level, which I gather is what--39 percent would be 
about the equivalent instead of the 36 percent that FDA 
recommends and that you--that CMS used to be 36-and-a-half in 
'97 or '98? Why the bump to 39?
    Ms. NORWALK. I think there are a number of different points 
to make with regard to that, Mr. Chairman. The first is that 
when you have a target level--and the CHOIR study actually 
looked at this; they were targeting 13-and-a-half; the average 
actually came in at 12.6. Our target is the FDA label, between 
11 and 12 or our 33 to 36. That is our--in fact, that's our 
policy.
    Chairman STARK. Okay.
    Ms. NORWALK. But from a payment perspective, if you're 
looking at payment changes, as Dr. Jenkins noted and as you 
noted the importance of an individual. So it could be at any 
particular time an individual may have a level that bumps up 
and it can take--I think actually the label says two to 6 weeks 
to change as opposed to two to four, but whatever it happens to 
be, our payments are monthly. And wanting to take into account 
the variation between payment between individuals not only over 
time but certainly between patients and not wanting to penalize 
a facility for doing what is correct, our monitoring policy 
really focuses now, and the changes that I announced this 
morning really focus on a persistent level at 39 or higher 
because that's where we really see a concern.
    From information that we received yesterday on the 
progression of dosage for patients who persistently have a 
hematocrit level of over 39, we've noticed that in the months 
following the first measure of 39 that dosages in fact do come 
down over time so that you'll have--if the dose in January is 
equal to one or 100 percent, the dosage in February, most 
recently with our new policy, has come down to under 70 percent 
of the initial dosage; the dosage in March under 50 percent; 
the dosage in April under 40 percent, so that our policy, we do 
think, has had some impact because these figures are better 
than what they were in '05 and '06.
    But I'm still concerned that the impact is not sufficient 
given the information that we've seen in the CHOIR study. But I 
think to do something more precipitously may have an adverse 
impact on patients that we're unaware, and so I think we need 
to be very careful in having people focusing on the payment 
side for something that's more of an outlier rather than 
allowing patients over time who may be 39 1 month and 36 the 
next.
    Chairman STARK. Would you then agree that a robust risk 
adjustment program and a good outlier policy could--would be a 
useful tool in managing this program?
    Ms. NORWALK. Oh, absolutely. That, coupled with appropriate 
quality indicators, yes.
    Chairman STARK. Mr. Vito, I don't know if you're the person 
to ask, but I'll try it anyway. Is there a--the Veteran's 
Administration, as I mentioned in my opening remarks, says that 
they save $3,000 to $4,000 a patient on their dosages. Do they 
pay--under the Federal supply schedule, do they pay a lot less 
for Epo than Fresenius or DaVita or John Jones Hospital?
    Mr. VITO. We haven't done that review recently. We had done 
a review, I believe, in 2004, around that time, where we 
compared the end-stage renal prices that the VA paid compared 
to what the Medicare was and we found that the VA prices were 
lower.
    Chairman STARK. Do you know about how much lower? I mean do 
you want to make a stab at that; half?
    Mr. VITO. I do not recollect that. I can provide that to 
you and I will be glad to do it after.
    Chairman STARK. Let's assume for a minute that it were 
half, okay, the VA is paying half of what the major providers 
are paying. And if we take the VA at face value and say they're 
saving $3,000 to $4,000, if somebody in fact is paying twice 
what the VA is paying for the drug, is my logic correct that 
therefore we might save $6,000 to $8,000, assuming the drug 
costs half? Does that make sense to you?
    Mr. VITO. I did not completely understand the question.
    Chairman STARK. Well, let's try this. The VA says, under 
their program of ``subcutaneous'' treatment and the level at 
which they use Epo, they're saving $3,000 to $4,000 per patient 
per year as opposed to using intravenous and more aggressive 
dosing.
    Okay, now if we accept that, and if they're paying half for 
the Epo that Fresenius is, wouldn't one assume that if 
Fresenius could buy the drug at 50 percent less and use the 
VA's protocols that they'd save $6,000 to $8,000 a year per 
patient?
    Mr. VITO. Well, we did not do that analysis, but it makes 
sense to me.
    Chairman STARK. Is my logic pattern there----
    Mr. VITO. Yes.
    Chairman STARK. Dr. Jenkins, you must have had a lot of 
math before you went to med school, is that----
    Mr. JENKINS. I still have my shoes on. It sounds fairly 
logical, but I'm not familiar with the difference between the 
VA protocol and the Fresenius protocol as far as their dosing 
strategy.
    Chairman STARK. Well, I think most of that savings they 
think comes from ``subcutaneous'' dosage instead of 
intravenous, but I don't know that.
    I want to thank the panel. Mr. Camp.
    Mr. CAMP. Thank you, Mr. Chairman. Mr. Vito, you mentioned 
the VA prices being lower, and as you get that information to 
the Committee would you please also include a patient mix 
analysis because I do think it's important, given the testimony 
we've had from Dr. Christensen that we understand, does the VA 
patient population mirror what we find in the private sector. I 
mean that's going to be a very important factor here in 
determining whether their prices are lower because of what 
they've done.
    But I think this testimony that we've had has really given 
us the intersection between medical treatment standards and 
payment policy standards and those are very different. I thank 
you, Ms. Norwalk, for making that distinction there.
    The Medicare Modernization Act in 2003 required a 
demonstration that would look at the feasibility of bundling 
all dialysis services into one composite rate. And I understand 
CMS has a report that's going to be coming out soon which will 
talk about the complexities of this issue, and I was wondering 
when this report might occur and why there have been delays in 
implementing a bundling demonstration.
    Ms. NORWALK. Two points. I promise that--I said this summer 
last December. I will be here through three or four more weeks, 
and it's still the summer when I leave. You will have it before 
I leave if it's the last thing I do.
    Now we appreciate that it's--it's a long process in 
administration to get policy out, but I appreciate the 
importance of it, and I made the promise. I intend to stick to 
it.
    Part of the reason why it took up longer than the October 
2005 deadline really relates to the research and wanting to be 
sure that before we put together a report to Congress, given 
the critical nature of the fact that 93 percent for ESRD is 
through Medicare, the importance of all the different 
indicators that could impact it, I think we were concerned with 
our initial research and felt more needed to happen before we 
could put together a report to Congress that recommended the 
bundled payment system.
    Now when it comes to the demonstration, clearly if we were 
to do a demonstration we should do it after we had the 
information from our researchers, but I will tell you that it 
is certainly my opinion that a demonstration is not necessary 
in order to go forward.
    Of the six prospective payment systems that we have done in 
the past seven years or so, four of them have not had a demo to 
have. And for a number of reasons, the demonstration, because 
of it's voluntary nature, may not provide the information that 
we would need, and we may be better off simply taking a look at 
what happens over time as we have with other case-mix adjusted 
systems and monitoring that and adjusting from 1 year to the 
next as we go forward, that it may be a more accurate 
assessment of what is required because everyone participates 
and it's not voluntary.
    Mr. CAMP. You touched briefly on the--not briefly, but you 
talked about ESA-monitoring policy that CMS has put in place. 
Are there any results of that that you can share with us that 
might be helpful?
    Ms. NORWALK. Well, I got--and I apologize for not, I 
literally got this in email last night, so it has taken us a 
bit to put together the data, particularly because it was very 
recent data, as recent as April and May of this year, and we 
looked at a number of different things, including the claims 
that were submitted, and what beneficiaries were in what range, 
what were the dosages that they were receiving and so forth.
    And we also took a look at those who had persistently 
higher--levels at 39 of above of hematocrit and wanting to take 
into account, well, what happened; did they actually reduce the 
dosage as our monitoring policy intended and what happened when 
you compared it to the similar cohort from 2005 and 2006 over 
the same months. And we have, in fact, seen some change, 
although I am concerned that the percentage of patients who 
were persistently at 39 or above remains about the same, in 
fact, is slightly higher.
    So it's--I think we need to do a little more work 
internally to figure out what these data mean so that we can 
put that into account as we develop the case mix adjustments on 
a go-forward basis.
    Mr. CAMP. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Doggett.
    Mr. DOGGETT. Thank you very much. Ms. Norwalk, you've 
talked about getting the study completed before you depart. I 
believe in your written testimony you estimate that it will 
take what seems to me like a longer period of time to actually 
implement a bundled payment system than it took to roll out 
Part D prescription drug, which you and I have discussed, from 
start. Do you--isn't there a way to get this job done quicker?
    Ms. NORWALK. I think, forgive me for interrupting. I think 
it's a very similar time period, so if the end--December 8, 
2003 versus the beginning of 2006 is about 2 years, and I 
would--to be fair to the staff who do our information systems I 
think we would be better served if we had slightly more time 
than that to ensure that our computer systems work and that we 
resolve whatever remaining issues there may be around case-mix 
adjustment for example.
    So two to 3 years is our requested timeframe, and part of 
that is just the amount of time it takes to do the proposed 
rule, get the comments, ensure that we are well informed from 
commenters, have time to reply to those, do any listening 
sessions that need to be done, work with the Committee 
certainly, before we put out a final rule, and then implement 
it.
    Now our systems changes from a computer perspective really 
depend on what else is going on and what else is changing and 
often that is a result of what happens here on Capitol Hill and 
what legislation changes because they fight for computer time, 
all the changes that we have. So two to 3 years, which is in 
line with where we were in the drug benefit.
    Mr. DOGGETT. Well, I usually find with CMS two to 3 years 
means four to five, but your best estimate and testimony today, 
is that 3 years from today?
    Ms. NORWALK. Well, it would be three--two to 3 years, three 
years if you pass legislation tomorrow. So it really is based 
on when the legislation passes as opposed to any particular 
other point.
    Mr. DOGGETT. Related subject. As you know, MedPAC 
attributes part of the increase in the ESRD population to the 
epidemic of diabetes that we have in this country, which is a 
major risk factor for ESRD. Given the importance of preventing 
the progression of both diabetes and ESRD, do you think it 
makes sense for CMS to expand coverage of nutrition therapy to 
target groups that have not fully developed diabetes as a 
preventive step?
    Ms. NORWALK. I know that we added a nutrition therapy 
benefit under the MMA, and it would be good for--I'm happy to 
go back and take a look and talk to staff as to whether or not 
it's been sufficient and how well it's been utilized. If it 
hasn't been well utilized is it because we need to do more 
education; what are the reasons? And is it broad enough that 
we're taking into account this particular vulnerable 
population? So let me get back to you with some answers on 
that, because I don't know.
    Mr. DOGGETT. Okay. Could you report back to our 
Subcommittee on that and whether you're able to do everything 
that you need on this nutrition therapy without any additional 
legislative authority, and if you feel any legislative 
authority is needed, whether you support that and what you 
support?
    Ms. NORWALK. Okay.
    Mr. DOGGETT. And then just one final followup on our 
discussion from your testimony last Thursday. You referenced me 
to a document that you said dealt with this prompt payment for 
community pharmacists. And I've looked at the document since 
then. As I understand it, the plans are reported back to you on 
their payment policies, is that right?
    Ms. NORWALK. Correct.
    Mr. DOGGETT. And did you collect any data regarding 
monitoring whether the payments were being made in accordance 
with the plans that you got reports on?
    Ms. NORWALK. Well, I can say this. I don't know if we did 
any systematic collection, but the beginning of 2006, probably 
for the first five, six months, a significant number of 
pharmacists were free to tell us and in fact did tell us on a 
fairly regular basis how unhappy they were with the timing of 
the payments.
    Since that time it has settled down quite significantly and 
I personally spent a fair amount of time working with the 
pharmacy community on a whole host of issues which are before 
CMS and I have--that issue really has not risen to the--really 
at all compared to where it was last year.
    Mr. DOGGETT. What you're saying is you're not getting as 
many complaints now as you got then?
    Ms. NORWALK. Well, almost no complaints now compared to a 
high volume then.
    Mr. DOGGETT. Have you done any--following your review of 
what the plans said they were doing, have you done any 
satisfaction study or survey of pharmacists to see whether 
they're satisfied with how the plans are being implemented or 
are you relying solely on the variation in the volume of 
complaints?
    Ms. NORWALK. I don't know that we've done a study but I 
will go back and--not that I'm aware of, but I'll go back and 
ask that question.
    Mr. DOGGETT. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Johnson.
    Mr. JOHNSON. Thank you, Mr. Chairman.
    Ms. Norwalk, you know, any changes in payment policy can 
affect patient care, so I'm sure you're extremely cautious. A 
2005 report shows that '97 to 2004, the number of dialysis 
patients with hemoglobin below 11, a level associated with a 
higher risk of mortality and hospitalization, has decreased by 
40 percent. I'd say that's a significant achievement.
    I fear this could be reversed if reverted back to a 
restricted payment policy for ESRD patients. Can you walk us 
through how the payment policy in '97 affected hemoglobin 
outcomes and why you changed the policy to give physicians more 
flexibility in treating anemia and do you think any changes, 
further changes, need to be made with respect to CMS policy?
    Ms. NORWALK. I believe that the policy 10 years ago was 
touched on a bit earlier, which is a rolling average of 36-and-
a-half percent. And then that was changed to 37-and-a-half 
percent.
    A couple of issues we had with that, one was the ability to 
actually implement that policy. Our carriers didn't understand 
it and the dialysis facilities also had difficulty figuring out 
how to make that work. So that's one of the reasons why we 
changed where we are now to focusing on a particular point in 
time and having a persistent level of hematocrit above 39 
percent.
    But I agree with your overarching point, which is, having a 
bundled payment system, one of the things that we need to be 
very concerned about is under-utilization so that we don't have 
hemoglobin levels below 11.
    One of the things that is important to do when we are 
working from a timing perspective to ensure that we have both 
quality metrics in place where we can measure for all 
facilities and all patients hematocrit levels over time or we 
can focus on other things like subcutaneous administration and 
other things that we think are better for the patient and 
really letting the physician treat that patient individually, 
so taking that into account by having both patient-focused risk 
adjustment factors as well as facility-focused risk adjustment 
factors.
    A combination of these things should lead us to a path 
where we don't have underutilization and don't have over-
utilization. But I think hopefully the next thing that we'll 
discuss is perhaps the evidence, what are those target numbers, 
where should we be focusing and are there differences in 
patient populations that we need to be concerned about so that 
we can consider that for case mix adjustment.
    Mr. JOHNSON. Thank you. You know, I think and I believe you 
believe market forces do a better job controlling prices than 
the government. What can we do to foster competition since we 
only have two therapies available at this time?
    Ms. NORWALK. Well, one of the things that we did for the 
third quarter of 2007 that--particularly if you're looking at 
the OIG numbers I think it's important to recognize the OIG for 
the similar time period a year ago had 9.58 for 1,000 units. 
Our recent pricing has $9.10.
    So the issue for a unit of Epo, for example, is what do--
you have to consider all the different provider types. You've 
got hospitals; you have the large chains, you have the smaller 
chains and so forth; profits, not-for-profits, et cetera, and 
wanting to take into account if you're having a single payment 
policy, particularly for acquiring ESAs, wanting to be sure 
that we can take into account what does it cost any of those 
facilities to acquire it and how can we let the market move in 
that direction.
    I suspect that over time there will be other ESAs to the 
market, and they may foster additional competition. And that's 
something that we should also take into account when we're 
setting our initial rates for a bundled payment system on a go-
forward basis.
    Mr. JOHNSON. You know, I don't think that you cover home 
dialysis and yet people say there's a higher savings and better 
patient outcomes. Can you give me a reason why you don't cover 
that?
    Ms. NORWALK. We do cover home dialysis. Most of the 
dialysis today provided in the Medicare setting is, in fact, 
done in a facility. I think one of the things that the report 
to Congress will touch on is the home dialysis piece, too, and 
I can't actually--see if I can find my notes. Because the vast 
majority is otherwise, our focus really has been from a 
facility perspective, but I think we want to take into account 
different payment methods in as much as something is done at 
home and you're working with a different supplier to provide 
the equipment that you would need and the drugs that you would 
need at home.
    So it's really a different fix for the issue, but since--
oh, so we do pay the same rate for both. So there we go, thank 
you.
    When you're doing a bundled system it might be--it's 
something I think that we have to take into account that 
differences in resources that you may have from one or the 
other. So our report to Congress will focus on that a bit more.
    Mr. JOHNSON. Thank you, ma'am. Thank you, Mr. Chairman.
    Chairman STARK. Thank you. Mr. Thompson.
    Mr. THOMPSON. Thank you, Mr. Chairman.
    Ms. Norwalk, I am interested in this idea of bundling 
payments that we've spent so much time on, and I'm concerned as 
to how that would be handled with different providers in 
different areas. And as I understand it, the big providers 
would have a fairly easy time with this, but I also understand 
that small, independent, rural providers may not and that they 
wouldn't be able to--maybe not even stay in business if we went 
to this form.
    So I'm interested in hearing from you, maybe the percentage 
of rural dialysis facilities that are independent as opposed to 
those that are affiliated with one of the larger organizations. 
Or maybe it would be better if I had an idea how many patients 
are served in rural areas by independents vis-a-vis the larger 
corporate ones. And what I'm really trying to get at is the 
impact that this would have on not just the rural providers but 
also the spillover effect that it may have on rural hospitals.
    Ms. NORWALK. My recollection is that about 70 percent of 
the reimbursement goes to the large dialysis organizations. So 
that gives you some sense of the percentage difference. About, 
is it 70 percent?
    Mr. THOMPSON. Yes, I'm told it's about 70 percent; the 
large guys control about 70 percent.
    Ms. NORWALK. Right, I think 70 percent is hospital-based.
    Mr. THOMPSON. And about 25 percent of all dialysis 
facilities are located in rural areas.
    Ms. NORWALK. Right. I think you raise a very good point, 
and there are a number of different things to take into 
account. One of the things that I suspect we ought to consider 
is whether or not something is called an isolated essential 
facility. And obviously in a number of our other payment 
systems, as you well know, we often will have differences in 
payments if something is in a rural area.
    Now in the report to Congress our main focus is based on 
resources; what does it cost to treat a patient and can we 
predict--what factors would we need to include in order to 
better predict the cost of a particular patient? And they're 
preliminary----
    Mr. THOMPSON. But this seems to me that it's different 
because some folks can internalize some of those costs, can 
absorb those, but this could have a very serious impact on not 
just the independent folks but other medical services that are 
provided in rural areas.
    Ms. NORWALK. Right, and you will find in our report that 
there is a--we do, in a sense, some impact analysis around 
rural areas, the large dialysis facilities, the hospitals, so 
it has--and I apologize; it would have been my preference for 
you to have that today, so I apologize that you don't in terms 
of looking at it, but the report does go through a number of 
different pieces.
    So when the Committee is considering legislation, they can 
take that into account, whether or not you might want to have 
an adjustment for both. But the size of the facility and so 
forth, in terms of resource use as well as whether or not 
something is rural, which is slightly different from your 
question, didn't have a significant impact through our cost 
analysis, so it doesn't help predict future costs.
    But that's not to say that it might not be an important 
consideration given, to your point, other healthcare facilities 
within a rural area and the ability to access that.
    Mr. THOMPSON. If the folks in a rural area take a hit in 
this area of their business it's going to affect something else 
that they're doing or something that they're not going to be 
able to do, and I'd like to know more about that. And if you 
any of you could provide information to the subcommittee on 
that, I would appreciate it.
    The other issue is I want to talk about the monitoring 
program. It's my understanding that this was put in place to 
get at the issue of over-prescribing and that there's a pretty 
significant hit, about 25 percent hit on this?
    Ms. NORWALK. That's the current policy, but as I noted in 
my oral testimony today, if someone is--a couple points. One is 
they need to have a modifier, and they would not have that 
payment reduction if they have reduced the dosage of the ESA. 
So the payment hit only occurs if they haven't reduced the 
dosage.
    The second policy that I noted in my testimony earlier----
    Mr. THOMPSON. Before you reiterate your other testimony, 
I'm running out of time. My concern is, is bundling going to 
bring about providers to underdose patients?
    Ms. NORWALK. It is a concern that we have.
    Mr. THOMPSON. How big of a concern?
    Ms. NORWALK. It's a very big concern, which is why I think 
it's critical we do quality monitoring at the same time that we 
do the implementation of the ESRD bundled payment.
    Mr. THOMPSON. But all you would do is find out that 
patients are put in a dangerous----
    Ms. NORWALK. No, I would suggest that we pay for 
performance, so in as much as a facility is underdosing an 
individual, their payment be reduced.
    Mr. THOMPSON. I would suggest rather than putting the 
program in place and then monitoring it to see if patients are 
put in a dangerous position that we do something to make sure 
they aren't underdosed.
    Ms. NORWALK. Sure.
    Mr. THOMPSON. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Hulshof?
    Mr. HULSHOF. Thank you, Mr. Chairman. Let me just follow up 
on a couple of points my colleagues on both sides have raised. 
First of all, Mr. Camp, Dr. Jenkins, I think it was to you, or 
maybe Mr. Vito, talking about a study comparing the VA patient 
population mix and making sure that it is in fact consistent 
with the patient population at large.
    Dr. Jenkins, it's my understanding as a lay person that 
normal hemoglobin values are different for children than for 
adults. Is that true.
    Mr. JENKINS. There are different normal ranges for 
hemoglobin based on gender and age, so that is correct.
    Mr. HULSHOF. Even kids as they grow older as they grow 
older. Those values change. Is that not also correct?
    Mr. JENKINS. The normal range is different. I don't have 
then in my head right now, but the normal range is clearly 
different from infants up to adults. And it also is different 
by gender.
    Mr. HULSHOF. Just curiously, I probably could have gotten 
this before the hearing. I know that there are 400,000 patients 
Medicare covers. Does anyone now approximately how many 18 or 
younger population that are served or that have ESRD? I'm just 
curious.
    Leslie?
    Ms. NORWALK. Someone here probably has that. It's quite 
small in terms of the population. It is, however, one of the 
things that we've taken a look a look at in our report to 
Congress, they're very expensive. The young patients are as 
expensive as the very old patients. So, it may have something 
to do with the ESRD or EPA required as well.
    Mr. HULSHOF. I'm not sure, Ms. Norwalk, in your remaining 
days how many more times we can bring you here. So let me take 
this quick opportunity to thank you for your service and what 
an extraordinary job that you've done, and wish you well in the 
future.
    One of the advantages that we have is that we get to 
examine testimony of the next panel. And I know you've probably 
been focused primarily on your own notes and the follow-up on 
something my friend from Texas, Mr. Johnson, asked. I think 
we're going to hear from the next panel from the Director of 
the American Association of Kidney Patients regarding home 
dialysis. Not only are there cost savings, but I think the 
testimony's going to be better patient outcomes.
    Is that something that is also going to be included in the 
long-awaited report?
    Ms. NORWALK. I think there is some detail there, but we 
really focused more overall on the bundled payment system and 
it's probably less on that. But I'd be more than willing to 
have staff come and brief the Committee on some what we've seen 
and we can figure out whether or not we would do a 
supplemental.
    Mr. HULSHOF. One of the things to that you mentioned in 
your presentation as you were trying to get as much information 
in on the five minutes allotted to you, you mentioned briefly 
the subcutaneous administration of EPO and you talk about. 
Well, you didn't get a chance to talk about it. Let me give you 
just a few minutes. We've seen studies that that type of 
administration would be safer, maybe cheaper.
    Are there some problems that you foresee in that regard, or 
what are your thoughts?
    Ms. NORWALK. Now, in fact, we think it is terrific to use 
subcutaneous, and we would like to promote that and would 
expect and anticipate if we went to a bundled policy that me 
may well see significantly more of it. But in one of the things 
that we have done for the past number of years is really focus 
on something called our fistula first policy, which encourages 
subcutaneous administration of ESAs.
    And we have a whole package around that, wanting to promote 
that, and are working with our quality improvement 
organizations to do just that so that patients may be slightly 
uncomfortable for them. So, maybe that's the, if there were a 
drawback, but I'd have to ask my favorite just behind me to 
answer that question, but we think clinically it makes a lot of 
sense and would like to encourage it.
    Mr. HULSHOF. Mr. Vito, in a few seconds, I've got 
remaining, following up a bit on what my friend from 
California, Mr. Thompson raised concerned that he and I and 
others share as far as putting our role providers in a very 
difficult situation. And I know that you mentioned, you all, 
the Office of Inspector General, sent surveys to a random 
sample of free-standing and hospital-based dialysis facilities 
and you've talked about that a little bit. In some of the 
things, specifically, to hone in on the price differences and 
acquisition costs which you talked about, in fact, you said 
that the chains are cheaper. Non chains don't get the group 
rate, if you will. And at least anecdotally, in a congressional 
district like the 9th District of Missouri, those non-chains 
are often in rural areas.
    If we were to bundle ESRD drugs in the composite rate, you 
think that rural areas are going to be put at risk, Mr. Vito?
    Mr. VITO. Well, our work did not break out the rural areas 
from the urban areas. Our work did demonstrate that there was 
variation depending upon whether it was a chain, a non-chain or 
a hospital. And just to use EPO as an example, if you were a 
chain facility, you were able to purchase that product for 
$8.55.
    If you were a non-chain facility, it would be 8.99. 
Hospitals would get it at 8.66, the average acquisition cost. 
Therefore, there are various pricing points. You have to be 
careful how you would bring that cost in, because if you would 
bring it in, for example, at the cost of the chain, then some 
of the other people will be disadvantaged, because they might 
not be able to purchase the drug at that price.
    So, clearly, it has to be thought out very carefully and we 
have to go through all those ramifications when you're 
establishing this.
    Chairman STARK. Thank you.
    Mr. Becerra.
    Mr. BECERRA. Thank you, Mr. Chairman. Thank you all for 
your testimony and let me focus first with you, Dr. Jenkins, 
and see if you can give me a better sense of something. Much of 
this has been very technical, and I suspect that for most 
people it's unclear what's been said and what the outcome of 
this hearing will be.
    When the FDA made its determinations that we should try to 
reduce the levels that we see when it comes to the hematocrit 
and to try to make sure that we don't cause other consequences 
for the health of others being treated for the various 
diseases, whether it's diabetes or other things, for EPO and 
these other drugs. Did you all come to the conclusion that you 
were very certain that we need to start reducing the levels 
that these drugs were being prescribed at and do it quickly?
    Mr. JENKINS. The decision we made was based on the data, 
primarily from two large studies, which in both cases were 
targeting hemoglobin levels higher than our labeling had 
recommended. And in both of those studies, one study was in 
patients on dialysis, the other study was on patients who were 
not on dialysis. Both showed an increase on adverse outcome, 
such as death, cardiovascular events such as heart attack 
stroke.
    So our concern was that we did not want patients to be 
exposed to higher doses to get their hemoglobin to higher 
levels, because we had clear evidence that higher was causing 
worse out comes. I think one of the major remaining questions 
and could really benefit from a lot more study is what is the 
optimal target, hemoglobin. Our labeling advises that you not 
go over 12.
    That's based on the data we have that showed studies that 
went over 12 had worse outcomes than patients who were treated 
under 12. But I think it's still a big uncertainty from our 
perspective what the optimal target hemoglobin might be for 
patients with renal disease.
    Mr. BECERRA. And you've sounded the alarm to some degree 
saying anything over 12 and we may start to run some ancillary 
risks to the patients. And, Ms. Norwalk, I hear what you're 
saying. As we try to treat these patients and get their various 
conditions under some control, we don't want to be driven so 
much by pricing or reimbursement rates in making those 
decisions about what ultimately their hemoglobin count should 
be, but there is a concern that if the alarm's been sounded and 
if we don't move quickly, we may continue to have this fairly 
large range under which we could see people prescribe the 
different drugs for the various conditions they may suffer.
    So, I'm wondering if you can tell us, do you feel 
comfortable having heard what FDA has said that CMS is moving 
quickly enough to give us an accurate read on where we should 
be on the hemoglobin count?
    Ms. NORWALK. We've done a couple of things. First, it's 
important to note we spend a fair amount of time talking with 
folks at the FDA as well as NIH and other sister agencies at 
the department just to make sure that we can have the most 
updated understanding about what their concerns are, so we can 
take that into account as we make policy about what's 
reasonable and necessary for Medicare payment, which of course 
is a different standard than safe and efficacious.
    From the payment policy perspective, there are two things: 
one, the black box warning, and one of the things it focused on 
was cancer or the non-renal setting; and we did make some 
immediate adjustments. In that particular regard, what we 
proposed in final will be forthcoming shortly. And the ESRD 
setting; I do think that our revised monitoring policy, we have 
seen some changes in prescribing patterns for patients who have 
hematocrit levels that are persistently high. But still wanting 
to take into account the fact that physicians need to have--
this is an individualized issue--physicians really do need to 
treat the patient and not be necessarily penalized when it's a 
patient issue as opposed to one of consistently doing something 
that may be not in the patient's best interest.
    So, maybe this patient takes 6 weeks to change hematocrit 
levels for whatever reason, because who knows what is going on 
physiologically. And because of that, because their payments 
are monthly, wanting to take into account monthly payments as 
well as physiological changes and not penalize a physician 
who's already done the right thing, but it may not yet be seen 
in the hematocrit level.
    So I do think that our payment policy is where it needs to 
be, and we will continue to monitor it over time and make 
adjustments if these changes haven't brought down the 
hematocrit levels to the point where they would be more in the 
range of the FDA label.
    Mr. BECERRA. And I hope we are able to get some clear 
movement on this, because for someone who's asking very 
pedestrian questions and still is trying to understand that's 
being said, I know that we do have to try to find savings, and 
I know we don't want to extract them at the expense of letting 
patients get the treatment they need. But now you have the FDA 
weighing in. So I'm hoping that at some point those who are the 
experts who understand this well, medically, technically, can 
give us some answers that make us feel comfortable that we can 
proceed quickly and that CMS can move as quickly as possible to 
give us what we ultimately want, which is a good reimbursement 
rate for those providing a very quality service to our 
patients.
    Ms. NORWALK. Agreed.
    Mr. BECERRA. Thank you. I yield back, Mr. Chairman.
    Chairman STARK. Ms. Tubbs Jones?
    Ms. TUBBS JONES. Mr. Chairman, thank you. To the panel, 
good afternoon. Well, good morning, still. And to the next 
panel, I've got to go be speaker pro tem, so I'm going to miss 
you.
    But I have in my hand a statement from a Dr. Peter D'Orio, 
who is from Cleveland Ohio, my congressional district. Having 
practiced internal medicine and nephrology for 27 years, he 
serves as medical director for dialysis facility for centers 
for dialysis care, non-profit. But this is his statement. 
Additionally, results from Oncology trials have raised safety 
questions about dosing and hemoglobin targets. While none of 
these trials included dialysis patients, these results have 
also been applied to the question of managing renal anemia. 
None of these studies showed any harm to dialysis patients 
treated to the currently accepted target range, but none of 
these studies show any benefit, however, from treating patients 
to targets over 13.
    The recent FDA revision and imposition of a black box 
warning causes serious problems for practicing nephrologists. 
If we are to interpret them literally, we are allowed to use 
ESAs only for the purpose of preventing transfusion. None of us 
would use blood transfusions to support the same hemoglobin 
ranges that we can achieve with ESAs. Would you agree or 
disagree, Ms. Norwalk, with that statement; Dr. Jenkins with 
that statement?
    Ms. NORWALK. One of the things that we've done at CMS is 
differentiate our payment policy on the basis, at least from a 
coverage decision, non-renal and renal. So, if your constituent 
is saying what I would be willing to bet my nephrologist, who 
is our chief medical officer, would agree with, there in fact 
are differences in treating those who are non-renal, i.e. 
cancer patients versus who are in ESRD. And we have taken those 
into account at CMS and do think those distinctions may be 
important, particularly given the duration of treatment. If you 
have anemia due to cancer treatment, you would use ESAs for a 
much shorter time period than you would if you are an ESRD 
patient.
    Ms. TUBBS JONES. Dr. Jenkins?
    Mr. JENKINS. We recognize that there are significant 
differences in the use of ESAs for cancer patients versus in-
stage renal disease patients. We've heard some of the same 
comments that you just read in that letter when we met with 
some of the renal physician societies and patient groups, and 
some of the dialysis providers a couple of months ago. And we 
are considering whether we should modify some of the language 
and are labeling to make some technical adjustments to avoid 
misunderstandings.
    For example, we recognize that it's impossible to always 
maintain every patient at 12 or below, given the variability of 
response and the other factors. So the fact that someone might 
occasionally have readings that are over 12, we didn't intend 
to imply that that was evidence that, you know, something was 
being done incorrectly. So, we've heard those comments and were 
considering whether to make adjustments. And we also have the 
cardiorenal advisory Committee coming up later this Summer to 
discuss some of these issues as well.
    Ms. TUBBS JONES. Mr. Vito, I didn't mean to leave you out, 
but I just thought the answer was better directed to Ms. 
Norwalk and to Dr. Jenkins. I'm going to yield my time, because 
I have to get to the floor. But I just want to say for the 
record, this is an issue that is of paramount importance to a 
whole lot of people, people that are patients, the physicians 
rendering the service, the people who run the dialysis center, 
the people who make the medication, and on, and on, and on. And 
all I want to lay on the table is caution that as we proceed 
down this road that we make sure that we have the best 
information we can with regard to making decisions so the 
people out there are getting the best service.
    My time's up anyway. I thank you very much for the 
opportunity, Mr. Chair. I give you 30 seconds back.
    Chairman STARK. Thank you. Mr. Pomeroy, want to use up 
those 30 seconds?
    Mr. POMEROY. Thank you, Mr. Chairman. I really don't know 
much about the subject of today's hearings, so I found this 
discussion quite interesting. And so, Mr. Vito, if we get back 
to the figures you talked to Mr. Hulshof about, the procurement 
costs between the chains, the non-chains, and the hospitals, 
you have figures. What are they?
    Mr. VITO. Okay, yes, we have the actual or the average 
acquisition cost as we calculated it. At the chain facilities 
for EPO, it was 8.55. At the non-chain, free-standing 
facilities, it was $8.99. And at the hospitals it was $8.66.
    Mr. POMEROY. That's just basically volume purchasing?
    Mr. VITO. I believe that the rebates, the chains started 
out with the higher price from the manufacturers, but got 
greater rebates to bring their prices lower than the non-
chains.
    Mr. POMEROY. The reimbursement rate is under the 
reformulation about $9.10?
    Mr. VITO. When we did our review, it was $9.48. I believe 
that they're changing the reimbursement to make it $9.10.
    Mr. POMEROY. When is that? Has that occurred? Is it 
occurring?
    Ms. NORWALK. It's implemented for July 1st. So those are 
the rates we announced June 15 for July 1.
    Mr. POMEROY. At the earlier rate of reimbursement, or the 
present rate of reimbursement before its upcoming change, was 
there differential in practice patterns indicating some kind of 
differential application of people?
    Ms. NORWALK. Well, certainly, one of the things that 
happened in preparing for this hearing is that I saw what the 
NIH submitted. So, I do think there are some variations and 
practice patterns, at least according to the NIH review of the 
U.S. RDS.
    Mr. POMEROY. And were those practice patterns subject to 
groupings, chain, non-chain hospital?
    Ms. NORWALK. At least, I think what the U.S. RDS reviewed 
is more chain specifically. So that's my recollection of their 
letter to the chairman. I would not be surprised, of course, if 
there are differences in some of these settings, hospital 
versus non-hospital. We see them occasionally, but the question 
is whether or not our revised payment policies can ensure that 
all of them are dosing at the appropriate amounts over time, 
and we can take into account differences in acquisition costs 
through a single reimbursement mechanism.
    So part of the concern and part of the reason that we're 
grateful that the OIG has done this study is focusing on making 
sure that all of the people who provide ESAs, we can reimburse 
something at least slightly above their acquisition cost, so 
they can acquire the ESA. I think the Medicare Modernization 
Act focused on having the OIG do the study on the average 
acquisition cost, but it's not practical for CMS to implement 
that over time.
    And so we used an average sales price. And what we're 
seeing is that the average sales price plus 6 percent has 
actually come down over time and now looks more like what the 
OIG focused on in terms of their review of third quarter '06 
data. So I don't know if that makes sense, but the conception 
is corporate.
    Mr. POMEROY. So, your take is they probably got the cost 
figures about right, chain, non-chain, hospital.
    Ms. NORWALK. Yes, we have no reason to disagree with that 
analysis. Correct.
    Mr. POMEROY. Do you believe that the $9.10 rate is going to 
make these differentials in application less likely?
    Ms. NORWALK. It really depends on whether or not the 
average sales price and what the manufacturers or those who are 
marketing the product, whether it's AmGen or Johnson & Johnson, 
how much they're selling and what rebates and discounts. Now, 
rebates and discounts are included in the definition of average 
sales price, so we take that into account. The question is, 
whether or not those mixes change from one quarter to the next.
    Another thing that happened that may have an impact here is 
also for July 1st, and we've included the use of these products 
in both settings. So we'll both have the cancer setting as well 
as ESRD. And this is a change that will have just occurred on 
July 1, which may have had some impact and some reason for 
bringing that price down to 9.10. So, not exactly sure how that 
might impact the average sales price in the future, but at 
least for the next quarter, it does have an impact of bringing 
that down a bit. And we did that implementing section 1847(a), 
the statute in terms of bundling those two different treatment 
types together.
    Mr. POMEROY. I would conclude, Mr. Chairman, by observing--
I wish we had more information. The information you're going to 
bring to us is going to be very important, I think, given the 
policy considerations before the Subcommittee. Thank you.
    Chairman STARK. Thank you. I wanted to just follow-up on 
this issue of payment. Mr. Vito raised it for non-chains who 
may very well be the smaller or the hospitals.
    Ms. Norwalk, you're familiar with the argument that's been 
proposed that we dare not use the Federal supply schedule, the 
VA's purchasing program to purchase pharmaceuticals, because 
the pharmaceutical companies will all hold their breath, turn 
blue and die and go away. However, where you have one supplier 
and one customer, we're the customer and AmGen is the supplier.
    I suspect that that argument wouldn't hold if we said to 
the supplier of EPO, you got to sell to everybody at the same 
price. We're talking 8.55 to 8.99, so if we said, if you're 
going to sell to the big chains at 8.55, you ought to sell to 
the smaller providers at that same price to give them some 
additional margin to stay in business.
    Other than the idea of not liking price regulation, but I 
don't believe the arguments on setting prices for other 
pharmaceuticals would hold if we did something to protect the 
smaller providers or the rural providers.
    Ms. NORWALK. I have to think about that. Certainly 
typically that argument has come up in the Part D setting and I 
do think the VA system and the Medicare system under Part D are 
vastly different. So there are reasons there for this. I'd have 
to give it a little more thought. I do think, ultimately, that 
there will be other drugs that come to market as these patents 
expire. So this is not a long-term issue. This is more likely 
to be in terms of how short-term, I have to check the patents; 
it probably depends in fact on litigation. But I do think that 
over time this will not be an issue that we're currently 
seeing. I'm not sure that we would want to put something in 
statute that would perpetuate something that the market can 
take care of later.
    Chairman STARK. Okay, a couple of questions very quickly, 
if I may, with Dr. Jenkins.
    AmGen will argue that research for pre-dialysis patients 
can't be used to extrapolate the dialysis patients. How do you 
respond to the argument that research for pre-dialysis patients 
can't be applied?
    Mr. JENKINS. Mr. Chairman, we understand that there are 
significant differences in the care and the physiology of 
patients who have in-stage renal disease who require dialysis, 
and those who are not on dialysis. I would just point out that 
as I mentioned earlier, there are two large studies. One that 
was reported in 1996 that was in dialysis patients and one that 
was reported last year, and non-dialysis patients, both of 
which raised concerns about adverse outcomes when they were 
treated to hemoglobin levels above 12.
    So that's why our labeling and our blocks warning addresses 
both to groups of patients recommending that you not target 
hemoglobins to those high levels.
    Chairman STARK. AmGen will also argue that there was a 
study for better health outcomes from trying to reach the 
hematocrit levels of a normal, healthy adult, and this AmGen 
argued that the research is not relevant because it was cut 
short. So I understand it was cut short for ethical reasons. Is 
it appropriate to use this research in guiding decisions about 
health risks? And would it be appropriate to recreate this 
study?
    Mr. JENKINS. Mr. Chairman, I'm not sure I'd know which 
study you might be referring to. Do you have any additional 
information?
    Chairman STARK. All I have to reference here is the normal 
hematocritic study tested whether there was better health 
outcomes for dialysis patients in trying to reach the 
hematocrit levels of a normal, healthy adult.
    Mr. JENKINS. Right, right. Okay, I do know about that 
study. That's the study that was reported in 1996. That study 
was intended to try to show that higher levels of hemoglobin or 
hematocrit were better and actually improved outcomes such as 
heart attack, stroke. In fact, that study was stopped early. It 
was stopped technically for what was called futility, meaning 
they could not show that higher was better. Our interpretation 
though is that there was asignificant worrisome trend that 
higher was worse. And that's why it was added to the labeling 
in 1996 to state that the mortality, the death rate in people 
treated with the higher levels of hemoglobin was higher than 
those treated at the lower level. So we do find that study to 
be informative, even though it was stopped early.
    Chairman STARK. Okay, and then there's an issue about 
quality of life and higher hemoglobin levels. Now, as I 
interpret that as a lay person, if you stoke me up with this 
stuff and I get way above 12, I'm going to feel great, but I 
may die.
    [Laughter.]
    Chairman STARK. It's like my mother wouldn't have the 
cancer operation. She said, ``As long as they don't run out of 
morphine, I ain't going to be operated on.'' Now, the quality 
of life from her standpoint is probably pretty good, never so 
good in her life. But, it did her in, finally.
    How do you assess this quality of life issue, I guess it's 
a doctor's responsibility to make damn sure that the patient 
knows that overdosing might make him feel better, but also 
might kill him. How does that wash?
    Mr. JENKINS. Well, Mr. Chairman, it's important to go back 
and recall that the basis on which we approve these drugs for 
use on patients with chronic renal failure was that it 
decreased the need for transfusions. Before these drugs were 
available, it was not uncommon for dialysis patients to have 
hemoglobins of 6, 7, 8, and be symptomatic from their anemia.
    In the studies that led to the approval, there was not an 
attempt to bring the hemoglobin or hematocrit back to normal. 
In fact, most of those studies brought the hemoglobin back up 
to 10, 11, and 12. And in those studies, we did see 
improvements in some of the measures are referred to as quality 
of life. And that information is in the Procrit and Epogen 
labeling. I don't know that we have evidence that treating to 
12, 13, 14 has been shown to improve quality of life above and 
beyond treating to 10, 11, 12.
    There is a point at which anemia is asymptomatic. You have 
the abnormal lab value, but you may not be symptomatic of the 
fact that your hemoglobin is below the normal range. So, our 
view is that there has been evidence shown in renal failure 
patients that bringing hematocrit up improves those measures 
and it's in the labeling. But I don't think we have seen any 
data suggests that going above the current target of 12 further 
improves those quality of life measures.
    Chairman STARK. Thank you. If there are no further 
questions of the panel, I want to thank the panel very much for 
your enlightenment this morning. And we'll call the third 
panel.
    Chairman STARK. I want to welcome Dr. A.J. Singh, Clinical 
Director of the Renal Division, Director of Dialysis Services 
and Associate Professor of Medicine at Brigham and Women's 
Hospital, Boston, Massachusetts;
    Mr. Kris Robinson, Executive Director and CEO, the American 
Association of Kidney Patients from Tampa Florida; and
    Dr. Alan Kliger, President of the Renal Physicians 
Association, Rockville, Maryland.
    Thank you for your patience. If you'd like to summarize 
your written testimony as previous witnesses have, your written 
testimony will appear in the record without objection.
    Dr. Singh, would you like to start?

  STATEMENT OF AJAY K. SINGH, M.D., CLINICAL DIRECTOR, RENAL 
 DIVISION, DIRECTOR, DIALYSIS SERVICES, ASSOCIATE PROFESSOR OF 
 MEDICINE, BRIGHAM AND WOMEN'S HOSPITAL, BOSTON, MASSACHUSETTS

    Dr. SINGH. Thank you Chairman Stark, Mr. Camp and Members 
of the Subcommittee on Health for the privilege of being asked 
to testify. My testimony will address three issues. The first 
is the target hemoglobin in patients with kidney disease.
    Chairman STARK. Excuse me just a minute. Could I get, if 
you could pull the mike there. The sound system is very 20th 
century here. Thank you.
    Dr. SINGH. My testimony will address three issues. First, 
the target hemoglobin in patients with kidney disease; second, 
the extensive off-label use and over utilization of reported in 
the United States, and three, thoughts on bundling of ES30 
services. With respect to the target hemoglobin concentration 
in patients with kidney disease, I fully support the recent FDA 
box advisory that a hemoglobin level should be maintained to 
less than 12 grams per deciliter.
    Randomized control studies have shown both in dialysis 
patients and in non-dialysis patients that this is a prudent 
recommendation. Indeed, the normal hematocrit study that Dr. 
Jenkins has already discussed was published in 1998 in the New 
England Journal of Medicine, and at the time, and I have a 
quite from that study. The study was halted when differences in 
mortality between the groups is the dialysis patients were 
recognized, sufficient to make it very unlikely that the 
continuation of the study would reveal a benefit. And the 
results were nearing the statistical boundary of higher 
mortality.
    So clearly both in the non-dialysis patient population and 
in the dialysis population, increased risk has been 
demonstrated. In our own study in the choir study, published in 
November of 2006, we not only demonstrated a 34 percent higher 
risk of death and cardiovascular complications, but also a 48 
percent higher rate of death among those treated or targeted to 
a higher hemoglobin.
    We also found that there was no incremental benefit in 
quality of life. Since the publication of these studies, the 
National Kidney Foundation, Kadokey panel will state in revised 
guidelines that the target hemoglobin should generally be 11 to 
12 grams per deciliter, a recommendation which I think would be 
compatible with the FDA. It's reassuring that the FDA has 
recommended caution in using ESAs, but past experience both 
with respect to this issue and with other drugs teaches us the 
powerful factors can stimulate continued and even increased 
off-label use of drugs. I would like to refer to the study by 
Dr. Cotter's group published in German, which document overuse 
of Epoetin in for-profit dialysis chains as compared to not-
for-profit chains. And I think there are potentially several 
explanations for this off-label overuse of Epoetin that's 
generated much higher doses be used.
    First, flaws in the current CMS reimbursement system. The 
new reimbursement schedule launched in April 2006 in fact 
facilitates over utilization of Epoetin. In our own dialysis 
chain, DCI, when we looked at data from prior to the Medicare 
changes and compared them to the more recent schedule, we found 
that the proportion of patients with higher hemoglobin values, 
above 13 grams, actually increased. And I was interested to 
hear Ms. Norwalk's testimony that in fact supported this at a 
more general level.
    We also have some data that will be published soon that 
suggests that the current CMS reinvestment system facilitate 
over utilization of hemoglobin above the FDA recommended level 
and higher Epoetin use. Second, I think another explanation for 
this over utilization is the use of standing orders that are 
based on corporate guidelines in dialysis facilities.
    Chairman Stark, you stated a Davita protocol, which 
actually recommends changes that Dr. Jenkins from the FDA 
didn't think were compatible with their recommendations. In 
other words, reductions that were less aggressive than the FDA 
would consider to be compatible with their recommendations. 
There's also marketing and rebate activities by pharmaceutical 
providers in driving off label use, which I won't go into 
details about. But it's certainly very present in the current 
marketplace.
    The other issue is with regards to ESA reimbursement is 
that the current reimbursement system facilitates over 
utilization, and therefore I would recommend and fully support 
the notion of bundling. I believe bundling of drugs such as 
ESAs will remove incentives for overtreatment. It will reduce 
the escalating cost for injectible drugs. It will encourage the 
use of subcutaneous administration of Epoetin, a practice which 
is widely utilized in the veteran administration system in 
Kaiser, and is certainly the case in Canada and other European 
countries.
    I believe that the Kaiser experience with ESRD bundling is 
really a live demonstration project, and I do agree with Ms. 
Norwalk that I do not necessarily see the need to actually have 
another demonstration project. We can learn a lot from Kaiser's 
system where they in fact do bundle and contract with for-
profit dialysis providers and there's large-scale use of 
subcutaneous Epoetin.
    And, finally, I believe that if bundling takes some time, 
CMS should modify its reimbursement policy so that the current 
over utilization that has accrued since and higher hemoglobin 
levels above 39 that have occurred since April 2006 gets 
corrected.
    I want to thank the Chair and Members of the Committee for 
listening to my testimony.
    [The prepared statement of Dr. Singh follows:]
 Statement of Ajay K. Singh, M.D., Clinical Director, Renal Division, 
 Director, Dialysis Services, Associate Professor of Medicine, Brigham 
              and Women's Hospital, Boston, Massachusetts
This testimony addresses 3 issues:
1.) The Optimal Target Hemoglobin In Patients with Kidney Disease
2.) The Extensive Off-Label Use and Over-Utilization of Epoetin in the 
        United States
3.) Bundling of ESRD services
The Optimal Hemoglobin Concentration in patients with kidney disease.

     I fully support the recent FDA Black Box Advisory \1\ that 
the hemoglobin level should be no higher than 12 grams per deciliter. 
Randomized controlled studies (RCTs), both in dialysis and in 
predialysis patients, demonstrate an increased risk of cardiovascular 
complications and death in patients targeted to a hemoglobin level that 
exceeds 12 grams per deciliter. In dialysis patients this was 
demonstrated in the Normal Hematocrit Study, published in 1998,\2\ and 
in non-dialysis CKD patients, this was demonstrated in the CHOIR study, 
published by us in 2006 \3\ The CREATE study \4\ reinforced the 
findings from CHOIR.
---------------------------------------------------------------------------
    \1\ www.fda.gov/cder/drug/advisory/RHE2007.htm.
    \2\ Besarab A, Bolton WK, Browne JK, Egrie JC, Nissenson AR, 
Okamoto DM, Schwab SJ, Goodkin DA. The effects of normal as compared 
with low hematocrit values in patients with cardiac disease who are 
receiving hemodialysis and epoetin. N Engl J Med. 1998 Aug 
27;339(9):584-90.
    \3\ Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, 
Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa 
in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98
    \4\ Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, 
Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization 
of hemoglobin level in patients with chronic kidney disease and anemia. 
N Engl J Med. 2006 Nov 16;355(20):2071-84
---------------------------------------------------------------------------
     Randomized controlled studies are superior to 
retrospective observational studies. While these retrospective studies 
have suggested benefit for cardiovascular outcomes or survival with 
targeting of a higher hemoglobin concentration, they are confounded by 
co-morbid factors and illness \5\ Continuing to cite these studies 
without providing RCT's contextually, as companies have continued to do 
is unnecessary, generates confusion, and undermines the FDA's strong 
safety message embodied in its Black Box advisory \6\
---------------------------------------------------------------------------
    \5\ Regidor DL, Kopple JD, Kovesdy CP, et al. Associations between 
changes in hemoglobin and administered erythropoiesis-stimulating agent 
and survival in hemodialysis patients. J Am Soc Nephrol. Apr 
2006;17(4):1181-1191.
    \6\ http://www.anemia.org/professionals/resources/slides/
---------------------------------------------------------------------------
     Aiming for and achieving a hemoglobin concentration in a 
narrow band of 11 to 12 g/dL may only be possible in approximately 2 
out of every 3 patients. As I have discussed elsewhere, expanding the 
target range to 10 to 12 g/dL seems not only prudent but also 
practical. This approach is prudent because of the safety concerns with 
hemoglobin concentrations greater than 12 g/dL as suggested by the 
RCT's and further reinforced by a recent meta-analysis published in the 
Lancet.\7\ This Lancet analysis aggregated studies of patients with 
kidney disease, whether on dialysis or not, and demonstrated a 17% 
increased risk of death with targeting a hemoglobin concentration of 
greater than 12 g/dl. While I agree with the notion that the target 
hemoglobin concentration level should b individualized based on patient 
need, in general, expanding the range to aim for a hemoglobin 
concentration greater than 10 g/dL but less than 12 g/dL should not 
result in a higher rate of blood transfusion, nor should it result in a 
worsening in quality of life.
---------------------------------------------------------------------------
    \7\ Phrommintikul A, Haas SJ, Elsik M, Klum H. Mortality and target 
haemoglobin concentrations in anemia patients with chronic kidney 
disease treated with erythropoietin: a meta-analysis. Lancet 2007; 
369:381-88
---------------------------------------------------------------------------
     We should accept that the proven benefit of erythropoetic 
stimulating agent (ESA) therapy is in preventing blood transfusions. 
Although, the FDA has recently pointed out that blood transfusions are 
much safer than ever before \8\ chronic kidney disease patients benefit 
from transfusions because of the avoidance of antibody sensitization 
(the latter decreases the likelihood of kidney transplant eligibility) 
and in reducing the risk of iron overload. Therefore, I continue to 
believe strongly that ESA treatment should be used to minimize the risk 
for blood transfusions; however, expanding the target hemoglobin range 
from 11 to 12 g/dL to 10 to 12 g/dL is reasonable, and should not 
meaningfully increase the proportion of patients requiring blood 
transfusion. On the other hand, quality of life benefits of a higher 
hemoglobin concentration are, at best, inconsistent. Studies have been 
dogged by methodologic issues, open label design, and the variable use 
and reporting of quality of life instruments. The CHOIR study showed no 
incremental benefit in quality in life with targeting a higher 
hemoglobin concentration and showed an increase in adverse events and 
complications.
---------------------------------------------------------------------------
    \8\ www.fda.gov/OHRMS/DOCKETS/AC/07/briefing/2007-4301b2-02-FDA.pdf
---------------------------------------------------------------------------
     The FDA issued a Black Box for all ESA's because of RCT 
data in kidney disease patients and because of emerging data from 
studies in cancer patients that suggested increased risk. The National 
Kidney Foundation (NKF) Kidney Disease Quality Initiative (KDOQI), in 
newly updated guidelines will also state that the target hemoglobin 
concentration in patients with kidney disease should generally be 11 to 
12 g/dL.
     It is reassuring that the FDA, empowered with evaluating 
the efficacy and safety of drugs in the United States, has recommended 
caution in using ESA treatment. However, past experience both with 
respect to this issue and with other drugs teaches us that power 
factors can stimulate continued and even increased off-label use of 
drugs. Every effort should be made to avoid continued off-label use of 
ESA's. Minimizing off-label use of ESA's will not only reduce CMS 
expenditure but will also be beneficial to ESRD beneficiaries and CKD 
patients collectively by reducing risk of higher hemoglobin 
concentrations and possibly higher doses of ESAs.
2) The Extensive Off-Label Use and Over-Utilization of Epoetin in the 
        United States

     As a recent New York Times Editorial,\9\ as well as 
articles by others \10\, has pointed out, trends in ESA utilization 
illustrate much that is wrong with reimbursement of ESAs. Off-label use 
of ESAs, and its over-utilization, are common-place and largely driven 
by flawed reimbursement, rebates, and over-zealous marketing of the 
drug.
---------------------------------------------------------------------------
    \9\ New York Times, May 14, 2007 Late Edition--Final, Section A, 
Page 18, Column 1
    \10\ Marlene Busko Is Medicare Reimbursement Policy for 
Erythropoietin in ESRD Flawed? http//www.medscape.com/viewarticle/
550594
---------------------------------------------------------------------------
     In 1998, approximately 10% of patients had hemoglobin 
levels that exceeded 12 g/L, whereas by 2000 this had rapidly grown to 
40% of all dialysis patients. Surprisingly, this steep increase in 
average hemoglobin levels occurred after the publication in 1998 of the 
Normal Hematocrit Study (NHS) showing a higher risk of death or 
myocardial infarction in aiming for a hematocrit of 42%. The authors of 
NHS indicated that concerns regarding excess mortality precipitated the 
decision to prematurely terminate the study.\11\ Two years before the 
publication of NHS--in 1996--the FDA added a new subsection in the 
Warnings section in the label of epoetin regarding higher mortality 
with hemoglobin levels of 12 to 140 g/L in patients with chronic renal 
failure (reviewed most recently at an FDA oncology advisory committee 
meeting). The steep increase in hemoglobin levels from 1996 onwards, 
coupled with a 50% increase in the average epoetin dose administered to 
dialysis patients during this time, needs to be further scrutinized.
---------------------------------------------------------------------------
    \11\ The NHS study was stopped because: ``Our study was halted when 
differences in mortality between the groups were recognized as 
sufficient to make it very unlikely that continuation of the study 
would reveal a benefit for the normal-hematocrit group and the results 
were nearing the statistical boundary of a higher mortality rate in the 
normal hematocrit group''.
---------------------------------------------------------------------------
     The study by Thamer and co-workers documents the overuse 
of epoetin in for-profit dialysis chains as compared to not-for profit 
chains, with for-profit facilities administering roughly a third more 
units of epoetin per week. Indeed, the for-profit chain DaVita utilized 
higher doses of epoetin at both lower and higher hemoglobin levels. 
Thamer and colleagues also confirmed an earlier observation that for-
profit chains especially DaVita had a higher proportion of their 
patients achieving hemoglobin levels greater than 12 g/dL when compared 
to the non-profit chain DCI.
     There are several potential explanations for the Off-Label 
Overuse of Epoetin.
     Pervasive incentives for ESA Overuse in current CMS 
reimbursement guidelines. The current CMS reimbursement schedule, 
launched April 2006, facilitates over-utilization of epoetin \12\ In 
work that has been submitted for publication, we assessed the impact of 
the change in CMS guidelines on hemoglobin levels and EPO usage in DCI, 
the largest not-for-profit dialysis chain in the United States. We 
evaluated \13\ the effect of a new protocol implemented on May 1, 2006 
to reflect the CMS policy change. We found that reducing rather than 
discontinuing epoetin supplementation at hemoglobin > 13 g/dL (the 
current CMS reimbursement schedule) was associated with a significantly 
greater proportion of hemodialysis patients at higher hemoglobin 
levels, higher cumulative epoetin use, and had no effect on the number 
of individuals with lower hemoglobin levels. Given recent studies that 
have demonstrated potential harm with higher hemoglobin targets, our 
study suggests that discontinuation rather than reduction of epoetin is 
appropriate when hemoglobin reaches 13 g/dL.
---------------------------------------------------------------------------
    \12\ Cotter D, Thamer M, Narasimhan K, ZhangY, Bullock K 
Translating Epoetin Research Into Practice: The Role Of Government And 
The Use Of Scientific Evidence. Health Affairs, 25, no. 5 (2006): 1249-
1259
    \13\ Weiner DE, Miskulin DC, Seefeld K, Ladik V, Zager PG, Singh 
AK, Johnson HK, Meyer KB: Erythropoietin Use and Hemoglobin before and 
after 2006 Changes in Medicare Reimbursement Guidelines. 2007. 
Submitted for publication
---------------------------------------------------------------------------
     The use of anemia protocols by dialysis providers and 
facilities. Administration of epoetin to patients at dialysis has both 
a facility and a physician component. Dialysis facilities have 
centralized corporate committees that formulate an anemia algorithm. 
This algorithm defines anemia targets and formulates epoetin and 
hemogklobin measurement orders that are instituted as part of the 
patient's standing orders. In addition, in many dialysis facilities, 
the dialysis facility has a designated employee who oversees anemia. In 
most facilities this is a nurse who evaluates the hemoglobin and iron 
values of individual patients, supervises the epogen over-fill 
utilization program, and ensures patient's compliance with the anemia 
protocol. The dialysis facility also expects the medical director, who 
receives a stipend or medical director fee from the dialysis facility, 
to ensure adherence to the anemia goals of the facility and of the 
dialysis chain. Individual dialysis physicians can and sometimes do 
over-ride the standing orders of the dialysis facility since they are 
ultimately responsible for the treatment of the patient under their 
care. Dialysis chains vary by the extent to which they provide autonomy 
to their medical directors and treating dialysis physicians in regard 
to the anemia protocol. The more aggressive dosing of epoetin 
recommended by DaVita is the likely explanation for the over-
utilization of epoetin in the DaVita chain as compared to DCI. For 
example, a corporate DaVita anemia protocol dated February 2007, 
recommends only a 10% reduction in epoeitin dose for hemoglobin 
concentration greater than 13.1 g/dl and less than 14 g/dL (and a dose 
reduction of 25% for hemoglobin concentration greater than 13.1 g/dl 
and less than 14 g/dL). In contrast, DCI recommends and immediate 
decrease in epoetin by 25% when the hemoglobin concentration exceeds 13 
g/dL. In our own dialysis unit in Boston, we discontinue epoetin when 
the hemoglobin exceeds 12 g/dl. Since these anemia goals and epoetin 
dosing recommendations are protocolized and managed by the facility, 
the current structure of anemia management in dialysis chains is a 
powerful driver for off-label use of epoetin and over-utilization of 
epoetin.
     Marketing and Rebate Activities by Pharmaceutical 
providers in driving Off-Label use. The pervasive effect of marketing 
and rebates to physicians have driven physician off-label use of ESAs. 
This is supported by recent press articles in both the New York Times 
\14\ and the Wall Street Journal \15\ and the British Medical Journal 
\16\ This is currently being investigated by the Senate Committee on 
Finance \17\ This has been discussed extensively in the scientific 
literature with regards to the promotion of gabapentin \18\ The 
influence of marketing activities on molding opinions about epoetin use 
is also concerning and has also been brought to light \19\
---------------------------------------------------------------------------
    \14\ Alex Berenson and Andrew Pollack, ``Doctors Reap Millions for 
Anemia Drugs'' The New York Times, May 9, 2007
    \15\ Heather Won Tesoriero and Avery Johnson, `Suit Details How J&J 
Pushed Sales of Procrit, Wall Street Journal, May 10, 2007
    \16\ Tonks A. Too much of a good thing. BMJ. 2007 May 
12;334(7601):978-80. Singh AK: Marketing Epoetin: Too Much of a Good 
Thing. http://www.bmj.com/cgi/eletters/334/7601/978
    \17\ http://www.google.com/
search?q=epogen+rebates+2007&hl=en&start=20&sa=N
    \18\ Steinman MA, Bero LA, Chren MM, Landefeld CS. Narrative 
review: the promotion of gabapentin: an analysis of internal industry 
documents. Ann Intern Med. 2006 Aug 15;145(4):284-93. (Letters and 
Response Ann Intern Med. 2007 Feb 20;146(4):313; author reply 313-4.)
    \19\ Dyer O. Journal rejects article after objections from 
marketing department. BMJ. 2004 Jan 31;328(7434):244.

     The limited use of subcutaneous epoetin in dialysis chains 
in the United States Evidence shows that approximately \1/3\ less 
epoetin is used when it is administered subcutaneously (SC) as compared 
to the IV route \20\ The SC dosing is certainly commercially less 
attractive and will influence profits for both pharma and dialysis 
providers. However, it will save the CMS substantial amounts of money 
because cumulative epoetin doses will be lower. The saving is likely to 
be in the range of 500 million or more. While some have argued that it 
is less convenient to patients and provider this issue does not seem to 
have adversely affected the VA population or those insured by Kaiser or 
for that matter thousands of patients in Canada and Europe. As well the 
use of lower doses of epoetin if given SC could be important if high 
doses of epoetin are shown to be associated with worse outcomes.
---------------------------------------------------------------------------
    \20\ (a. Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, 
Kleinman JG, Vaamonde CA. Subcutaneous compared with intravenous 
epoetin in patients receiving hemodialysis. Department of Veterans 
Affairs Cooperative Study Group on Erythropoietin in Hemodialysis 
Patients. N Engl J Med. 1998 Aug 27;339(9):578-83. b. Parker KP, Mitch 
WE, Stivelman JC, Macon EJ, Bailey JL, Sands JM. Safety and efficacy of 
low-dose subcutaneous erythropoietin in hemodialysis patients. J Am Soc 
Nephrol. 1997 Feb;8(2):288-93. c. Kaufman JS. Subcutaneous 
erythropoietin therapy: efficacy and economic implications. Am J Kidney 
Dis. 1998 Dec;32(6 Suppl 4):S147-51.
---------------------------------------------------------------------------
3) Bundling of injectibles, including ESAs, by including its 
        reimbursement into the ESRD composite reate should be adopted.
     Bundle of injectible drugs into the reimbursement of the 
dialysis procedure, i.e., into the composite rate offers several 
benefits and should be adopted.
    a.) It removes incentives for over-treatment--aiming for higher 
hemoglobin levels using higher and higher doses of epoetin.
    b.) It will reduce the escalating costs for injectible drugs, 
particularly ESAs, in the treatment of dialysis patients.
    c.) It will encourage the use of subcutaneous administration of 
epoetin--a practice widely used in Europe, Canada, and in the VA 
system.
    d.) This should facilitate lower doses of ESAs in the treatment of 
anemia.
     Utilize the Kaiser Experience with ESRD Bundling. As I 
have pointed out elsewhere,\21\ the Kaiser Permanente system provides 
an accessible and functioning model of ESRD bundling. This system 
functions without risk adjustment of payments and has resulted in 
largescale use of subcutaneous epoetin administration.
---------------------------------------------------------------------------
    \21\ Singh AK et al Letter to JAMA. 2007. In press.
---------------------------------------------------------------------------
     In the near-term, CMS should modify its reimbursement 
policy. This will be important in reducing epoetin over-utilization and 
to conform more robustly with the FDA Black Box Advisory. Indeed, CMS 
has done this with reimbursement of the oncology indications for 
epoetin therapy.
Summary
    I recommend that the importance of following the FDA Black Box for 
epoetin in the treatment of anemia of kidney disease should be 
followed.
    a.) The hemoglobin target should be less than 12 grams per 
deciliter.
    b.) The extensive off-label use of epoetin and its overutilization 
requires greater scrutiny.
    c.) Medicare should modify its reimbursement policy to adopt a 
bundled reimbursement approach. This will, at least in part, remove the 
incentive for higher epoetin use, increase subcutaneous administration 
of epoetin, and restrain spending on ESAs.

                                 

    Chairman STARK. Thank you.
    Ms. Robinson.

    STATEMENT OF KRIS ROBINSON, EXECUTIVE DIRECTOR AND CEO, 
    AMERICAN ASSOCIATION OF KIDNEY PATIENTS, TAMPA, FLORIDA

    Ms. ROBINSON. Thank you, Mr. Chairman, and Members of the 
Committee for inviting me here to testify. My name is Kris 
Robinson and I am the Executive Director and CEO of the 
American Association of Kidney Patients. AAKP is the only 
national, non-profit organization founded and directed by 
kidney patients for kidney patients. Our organization is 
dedicated to serving the needs and interests and welfare of all 
kidney patients and their families. And this is the very reason 
I am here before you today.
    In 1971, our organization's then Vice President, Shep 
Glazer, made history here in the House Ways and Means Committee 
Room, testifying while he was actually hooked up to a kidney 
dialysis machine and receiving dialysis. Within a year, our 
government took action, passing landmark legislation in 1972 to 
cover the cost of kidney dialysis through Medicare.
    As a kidney transplant recipient myself, I am well aware of 
the human and financial cost of kidney care. Let me begin by 
stressing how important it is to get the dosing of ESA's right 
for kidney patients. AAKP supports achieving a hemoglobin level 
of 11 to 12 grams per deciliter, as indicated by the FDA label 
for ESAs. We view current CMS monitoring policy as somewhat 
out-of-sync with where the FDA is and where the mainstream 
medical community is.
    Although each case is different from a patient perspective, 
there is very little medical reason for a patient to remain at 
levels above 13 grams, especially in light of the current 
literature citing safety issues. I myself receive Epogen for 
anemia, and my doctor would not delay before titrating me down 
from a level of 13.
    AAKP strongly adheres to the principal that a physician and 
patient must be permitted to decide a care plan best suited for 
that patient. Separate Medicare reimbursement for ESAs 
potentially distracts from the doctor/patient decisionmaking 
relationship. So we support bundling Medicare reimbursment for 
ESAs into the overall Medicare reimbursement rate. We believe 
that bundling the payment would not only result in cost 
savings, but also result in more appropriate dosing of ESAs and 
draw more attention to the comprehensive nature of kidney care.
    Let me emphasize that underdosing of ESAs is a danger too. 
Many kidney patients remember the difficult times before the 
ESAs were available, suffering the debilitating fatigue 
associated with anemia. We don't want to scare patients away 
from being treated with this valuable life-enhancing 
medication. Nor would we want to create a perverse incentive 
that causes providers to skimp on doses of ESAs because they 
would no longer be receiving separate reimbursement.
    What we need is a Medicare policy that strives for a 
goldilocks solution to ESAs; not too much; not too little; but 
just right. So we believe Congress should 1) establish 
guidelines regarding the proper dosage of ESAs, and 2) link 
reimbursement to meeting those guidelines. Let me say just a 
few words about potential subcutaneous administration.
    We surveyed 3700 patients about ``subcut'' administration 
of Epoe and found that patients are very willing to do 
``subcut''. An overwhelming majority of patients told us they 
wouldn't mind getting an Epoe shot and even giving themselves 
the shot. Many of these patients are already receiving 
administration shots because of diabetes.
    Mr. Chairman, let me briefly mention three quality 
recommendations and not that I have included others as well in 
my written statement. First, we strongly support legislation 
that would extend Medicare coverage to patient education 
services and would allow patient education for predialysis 
patients. The earlier we can start educating patients regarding 
behavior, nutrition and other matters in their stages of 
chronic kidney disease, the fewer health problems will result 
later.
    Second, there is currently no standard for training and 
certification of technicians in the centers. Some states, like 
Texas, have strong standards they must meet. Other states, like 
my home state of Florida, have none at all. AAKP would like to 
see standard training requirements that at least set a minimum 
for dialysis technician training.
    Finally, some patients choose the option of daily home 
dialysis, which can be administered six times a week for 2 
hours a day. Unfortunately, Medicare will cover three dialysis 
sessions per week. If Medicare were to cover more frequent home 
dialysis, patients would have better outcomes and we believe 
there would be a cost savings to the program. Home dialysis 
patients use one-third less hospitalization; one-third less 
EPO; one-third less hypertension medicine, and more of them can 
stay in the workforce.
    Mr. Chairman, we applaud your leadership over the years on 
these issues that are so important to us as kidney patients. We 
offer ourselves as a resource to you as your Subcommittee works 
on these issues.
    Thank you and I look forward to responding to your 
questions.
    [The prepared statement of Ms. Robinson follows:]
   Statement of Kris Robinson, Executive Director and CEO, American 
             Association of Kidney Patients, Tampa, Florida
    Mr. Chairman, Ranking Member Camp, and members of the Committee, 
thank you for inviting me before you today to testify. My name is Kris 
Robinson and I am the Executive Director and CEO of the American 
Association of Kidney Patients (AAKP) headquartered in Tampa, Florida.
    AAKP is the only national non-profit organization founded by kidney 
patients, for kidney patients. AAKP serves over one million Americans 
annually who have either lost kidney function (and live with dialysis 
or transplant) or have chronic kidney disease (CKD). Our organization 
is dedicated to serving the needs, interests, and welfare of all kidney 
patients and their families.
    And this is the very reason I am here before you today. It was 36 
years ago, in 1971, when our organization's Vice-President, Shep 
Glazer, made history here in the House Ways and Means Committee Room 
testifying while he was actually hooked up to a kidney dialysis machine 
and receiving dialysis. Within a year our government took action, 
passing landmark legislation in 1972 to cover the costs of kidney 
dialysis through Medicare.
    Mr. Chairman, we thank you for holding this important hearing 
because, as you know, the government's policies towards kidney care 
today have room for improvement. As a kidney transplant recipient 
myself, I am well aware of the human and financial cost of kidney care. 
Our nation has the unique opportunity to provide better outcomes for 
kidney patients--and this can lead to substantial cost savings because 
better outcomes translate into less reliance on the drugs, dialysis, 
and hospitalization currently covered by Medicare.
    I want to begin by addressing issues regarding anemia management 
for kidney patients and then also raise several quality improvement 
recommendations for your Subcommittee's consideration.
Appropriate Use of ESAs
    Let me first stress how important it is to get the dosing of ESAs 
(erythropoiesis stimulating agents) right for kidney patients. AAKP 
supports achieving a hemoglobin level of 11 to 12 grams per deciliter, 
as indicated by the FDA label for ESAs.
    We view current CMS monitoring policy as somewhat out of sync with 
where the FDA is and where the mainstream medical community is. 
Although each case is different and there will always be outliers, from 
a patient perspective there is very little medical reason for a patient 
to remain at levels above 13 grams, especially in light of the current 
literature citing safety issues. I myself receive epogen for anemia and 
my doctor would not delay before titrating me down from a level of 13; 
nor would AAKP's Medical Advisory Board recommend waiting before doing 
so.
    Yes, we realize that CMS' monitoring policy is a payment policy and 
not a policy to set therapeutic targets, but payment policies can often 
affect decisions regarding treatment options. Since we know overdosing 
can lead to potentially severe outcomes, we are concerned the current 
payment policy could provide incentives for overdosing.
Bundling:
    Because every medical case is unique, AAKP strongly adheres to the 
principle that a physician and patient must be permitted to decide a 
care plan best suited for that patient. Averages and other statistics 
are fine for certain purposes, but let's remember that medicine is 
fundamentally about the treatment of a unique individual.
    In this light, we worry about any policy that clouds the doctor/
patient decision-making relationship for treatment options. Separate 
Medicare reimbursement for ESAs potentially distracts from the doctor 
and patient deciding which course to pursue. That is why we support 
bundling Medicare reimbursement for ESAs into the overall Medicare 
composite reimbursement rate for ESRD. We believe that bundling the 
payment would not only result in cost savings, but also would result in 
more appropriate dosing of ESAs and draw more attention to the 
necessarily comprehensive nature of kidney care. It is important, 
however, to ensure that any bundling structure include risk-adjustment 
so as not to inadvertently create a disincentive for providers to cover 
the sickest patients.
ESA Guidelines:
    Having said that, let me emphasize that underdosing of ESAs is a 
danger too. Many kidney patients remember the difficult times before 
ESAs were available, suffering the debilitating fatigue and adverse 
health affects associated with anemia. None of us want to return to 
those days and we do not want to scare patients away from being treated 
with these valuable life-enhancing medicines. We also do not want to 
create a perverse disincentive that causes providers to ``skimp on'' 
doses of ESAs because they would no longer be receiving separate 
reimbursement.
    What we need is a Medicare policy that strives for a ``Goldilocks'' 
solution on ESAs: not too much, not too little, but ``just right.''
    We believe, therefore, it would be useful to: 1) establish 
guidelines regarding the proper dosage of ESAs, and 2) link 
reimbursement to meeting those guidelines. AAKP has long supported 
linking quality of services to payment for those services.
Subcutaneous Administration of ESAs:
    Before leaving the discussion of ESAs, let me say a few words about 
potential subcutaneous administration of ESAs. As you know, one-third 
less dosage can be used in subcutaneous administration versus 
intravenous administration, resulting in substantial cost savings and 
better outcomes. The Veterans Administration typically administers ESAs 
subcutaneously.
    AAKP surveyed 3,600 patients when the NKF-DOQI guidelines were 
first released. At that time, DOQI stated that patients should receive 
their EPO subcutaneously as opposed to intravenously. We surveyed 
patients concerning the factors they felt doctors should consider when 
deciding which route (subcutaneous or IV) to administer EPO.

      93% felt it was ``very'' or ``extremely'' important that 
the doctor make the decision based on ``how EPO works best for me.''
      67% felt that it was "very`` or ``extremely'' important 
for doctors to consider the patient's preference with regard to route 
of administration.
      74% wanted to be involved in the decision making process.
      Patients also were willing to have EPO administered 
subcutaneously if they felt it worked best, was more economical, and 
they could be trained.
      Patients overwhelmingly told us they didn't mind getting 
a shot--even giving themselves a shot--if it would make them feel 
better. Most of these patients are already self-administrating 
medication due to their diabetes, so one more shot doesn't faze them.

    My point is that our survey of 3,600 patients shows that they would 
readily accept subcutaneous administration of ESAs. As far as I know, 
ours is the only such survey data on this question.
Quality Improvement Recommendations
    Mr. Chairman, as you know, AAKP has been intimately involved with 
how kidney care is delivered since the advent of kidney dialysis a 
generation ago. Based on our 36 years of experience, we offer the 
following programmatic recommendations for your Subcommittee's 
consideration:
    1) Patient Education:
    AAKP is one of the nation's leading providers of patient education 
materials and services. Medicare currently does not cover patient 
education services. We strongly support legislation that would extend 
Medicare coverage to patient education services and would allow patient 
education for pre-dialysis patients. The earlier we can start educating 
patients regarding behavior, nutrition, and other matters in their 
stages of chronic kidney disease, the fewer health problems will result 
later.
    2) Standards for Dialysis Technicians:
    The quality of services varies considerably in dialysis centers 
across the country. There is currently no standard for training and 
certification of technicians in the centers. Some states, like Texas, 
have strong standards that must be met. Other states, like my state of 
Florida, have none at all. AAKP would like to see standard training 
requirements that at least set a minimum for what training dialysis 
technicians should receive.
    3) Coverage for Home Dialysis:
    Dialysis patients typically receive treatment three times a week 
for four hours a day at a dialysis center. Some patients, however, 
choose the option of daily home dialysis, which can be administered six 
times a week for two hours a day. Unfortunately, Medicare only covers 
three dialysis sessions per week even though more frequent home 
dialysis can promote better outcomes and save money.
    Studies show that daily dialysis translates into lower 
cardiovascular event rates, which is the leading cause of death in 
kidney patients. Patients undergoing daily dialysis felt much better, 
especially noting increased energy, better physical functioning, 
clearer thinking, better control of their anemia and reduced symptoms 
related to their kidney disease and the dialysis treatments.
    Daily dialysis can result in savings because: 1) four times as many 
nurses are needed for conventional dialysis as opposed to home 
dialysis; 2) hospitalization for daily dialysis patients is reduced by 
34%; 3) weekly EPO dosage is reduced by an estimated 41%; and 4) the 
number of antihypertensive drugs is reduced by 46%. Further, patients 
undergoing home dialysis have a much greater flexibility in their 
schedule and are more likely to stay in the workplace.
    4) Lifetime Coverage for Immunosuppressive Drugs:
    Medicare coverage for immunosuppressive drugs can expire after 36 
months even though kidney transplant recipients need to take the drugs 
for the rest of their transplanted lives. Many patients who no longer 
can afford the costs will stop taking the drugs. This leads to graft 
failures, which cause patients to go back on dialysis and wait for 
another transplant.
    Considering that immunosuppressive drug coverage costs 
approximately $1,000 per month while dialysis costs $4,000 per month 
and a transplant costs 100,000, it makes fiscal sense to extend 
Medicare immunosuppressive drug coverage for life.
    5) Extending Medicare Coverage to Stage 4 of ESRD:
    Medicare only covers the fifth (and final) stage of ESRD, but this 
is clearly not in the best interests of the patients. The Renal 
Physicians Association has stated, ``Proactive preparation for RRT 
(Renal Replacement Therapy) is recommended to facilitate the transition 
and reduce the burden of clinical risk factors known to be associated 
with worse outcomes in ESRD patients.'' Out of the 28 guidelines the 
RPA recommends in their physician practice guideline manual, 27 include 
treatment in both stage 4 and 5, not just in stage 5.
    A demonstration project would serve to quantify the health and 
fiscal benefits of stage 4 coverage.
    6) Medicare Coverage for Fistulae Before Stage 5 Eligibility:
    The benefits of AV fistular access are already recognized by CMS, 
who recently enacted a ``Fistula First'' policy geared towards 
increasing the number of people who choose this treatment. AAKP 
strongly endorses the ``Fistula First'' policy. Fistulae last longer, 
need less rework, and are associated with lower rates of infections, 
hospitalization, and death for Medicare beneficiaries than other types 
of access.
    However, Medicare coverage does not begin until a patient is at 
stage 5 of ESRD and an AV fistula should be put in months earlier. We 
believe this is why fistular access rates are lower than they should 
be--substantially lower in the United States than in Europe and Japan. 
Medicare should cover surgical placement of fistulae in stage 4.
    7) Medicare Secondary Payer:
    Lastly, AAKP opposes proposals to make Medicare the secondary payer 
for ESRD services. We believe that the health of patients is enhanced 
by receiving the comprehensive spectrum of services covered by 
Medicare. Some proposals would delay Medicare coverage for as long as 
60 months. Mr. Chairman, 60 months is five years, and kidney patients 
in Stage 5 have an annual mortality rate of 25% and a life expectancy 
of only five years. So making Medicare the secondary payer would mean 
only the healthiest patients even make it to Medicare coverage. 
Delaying Medicare coverage increases cost-sharing for patients, and we 
believe it would undermine patient well-being in many cases.
    Mr. Chairman, we applaud your leadership over the years on these 
issues so important to kidney patients. Our government can vastly 
improve the quality of care for kidney patients while saving money in 
many areas. Thank you for having me here to testify today and we offer 
ourselves as a resource to you for further information as your 
Subcommittee works on these issues in the months ahead.

                                 

    Chairman STARK. Thank you.
    Dr. Kliger.

STATEMENT OF ALAN S. KLIGER, M.D., PRESIDENT, RENAL PHYSICIANS 
                ASSOCIATION, ROCKVILLE, MARYLAND

    Dr. KLIGER. Thank you, Mr. Chairman, and Member of the 
Committee. My name is Alan Kliger. I'm a kidney specialist and 
a Clinical Professor of Medicine at Yale University School of 
Medicine, and I'm chairman of the Department of Medicine at the 
Hospital of St. Raphael in New Haven, Connecticut.
    I'm an employee of a not-for-profit hospital, and for the 
record, I'm not in the employ of any drug companies or other 
commercial enterprises. I'm also President of the Renal 
Physicians Association, the professional organization of 
nephrologists, whose goals are to ensure that patients 
suffering from kidney disease receive the best care delivered 
under the highest standards of medical practice. And last, I'm 
the past president of the Forum of ESRD Networks, a national 
organization of regional networks under contract with CMS to 
promote and oversee quality improvement at dialysis and kidney 
transplant facilities, and to ensure access of care for all 
patients who need dialysis.
    First I'd like to thank you, not only for inviting me to be 
here, but for allowing me to give voice to those whose real 
world practical experience has sometimes been overlooked--the 
practicing nephrologist who cares for kidney disease patients 
every day.
    Today you're examining the safety concerns regarding dosing 
of ESAs, variations in utilization and reimbursement. 
Nephrologists have a long record of experience with safe and 
effective use of these agents. Nearly 15 years ago, the kidney 
community helped to develop evidenced-based clinical guidelines 
passed on a systematic review of the published evidence. I 
served on the steering Committee of the National Kidney 
Foundation's DOQI, which was charged with developing guidelines 
for dialysis patient care, including anemia management.
    I also participated in the then-HCFA-funded development of 
16 clinical performance measures designed to measure what 
doctors actually do, give them feedback, and help them to 
refine their patients in order to do what works best. The 
dividends we saw from that effort were that most nephrologists 
used to effectively use practice guidelines, and we saw 
measurable improvements in the quality of care.
    In the past year, several new publications on the effect of 
ESAs have drawn everybody's attention to these safety and 
efficacy questions. Our patients read and hear these stories. 
Many have asked us what these findings mean to them, should it 
change their treatment, and should they be concerned?
    We owe it to them to carefully review each new study, 
critically analyze its findings, and based on that analysis, 
revise guidelines to conform with the latest scientific medical 
knowledge. For example, the latest evidence warns us that 
kidney failure patients should not have high blood counts.
    Dr. Singh's study showed us that a group of patients with 
high blood counts in general carried a higher risk than 
patients with lower blood counts. The challenge to 
nephrologists is how to best adjust their medicine to achieve 
these safe and effective blood levels. Every patient is unique. 
When it comes to ESA dosing, each patient must be considered 
individually, not in the aggregate. A dose of EPO that works in 
one patient will not necessarily work in another. Focusing on 
dosing levels at the aggregate rather than the patient level 
does not take into consideration the very real issue of patient 
variability. Responses to ESAs may vary from patient to patient 
and even change from one patient--in one patient from one time 
to another. This biologic variation requires individual fine 
tuning to get the best results.
    Also, please understand that guidelines are not rules. 
They're in place to give doctors and their patients advice on 
the best practice to follow. But since each patient and their 
response to treatment is different, clinical decisions and 
prescription choices are made one patient at a time, based on 
what options provide that patient with the best care and 
treatment possible.
    Most of the time, that's what the recommendations suggest. 
But sometimes it's not. Mr. Chairman, I have a 52-year-old 
patient I'll call Ted, who has kidney failure. When his blood 
count is less than 36 percent, he feels tired and washed out. 
He has difficulty getting up to work in the morning, and 
experiences chest pain. When EPO raises his blood count to 38 
percent, he feels like a healthy man again. He functions better 
and feels more productive. In fact, the differences are so 
prominent to him that he tells me what his blood counts are 
before I have a chance to measure them.
    So while the most recent guidelines say I should keep his 
blood count at less than 36 percent, he understands the risks 
of a higher blood count, and he and I both know that what he 
needs in order to function as normally as he can is a higher 
level.
    Yes, absolutely, doctors must be held accountable for best 
practice. But they must also be allowed to use professional 
judgment, weigh the evidence, consider their patient's wishes, 
and then decide what's best one patient at a time.
    I agree there should not be financial incentives to overuse 
drugs like ESAs. I want to underscore the fact that in dialysis 
units, the financial incentives are not given to the doctors. 
The dialysis owners have financial arrangements with the drug 
companies, but the doctors who prescribe these medicines 
receive no such incentives.
    Mr. Chairman, we know that kidney failure can be delayed or 
prevented. We know that finding and treating high blood 
pressure in its earliest stages, treating diabetes and high 
cholesterol, getting patients to stop smoking, all lead to 
better kidney health. Nearly 20 million Americans have some 
form of kidney disease, but most don't know it. To help 
identify these individuals and get them into treatment as early 
as possible, some states now require medical laboratories to 
report to doctors on the estimated kidney function when routine 
blood tests are being performed. The earlier the intervention, 
the less chance they will eventually need dialysis or a 
transplant.
    Those are the goals that the RPA endorses and that 
individual nephrologists strive for. As this Subcommittee 
considers all of the evidence surrounding this very complex 
issue of anemia management, I urge you not to lose sight of one 
very critical factor in this equation; biologic variability 
makes dosing an individual challenge. Each physician's clinical 
judgment plays a critical role in achieving the highest quality 
of care for his or her patients.
    I'd like to take this opportunity to recognize and thank 
Congressman Camp and Congressman Lewis for their leadership in 
advancing the Kidney Care Quality and Education Act championed 
by the Kidney Care Partners, a coalition of kidney partners of 
which RPA is a member. And I'd also like to recognize the 
commitment over the years that you, Chairman Stark, and 
Congressman McDermott have made to improve the health of all 
kidney patients.
    Thank you.
    [The prepared statement of Dr. Kliger follows:]
    Statement of Alan S. Kliger, M.D., President, Renal Physicians 
                    Association, Rockville, Maryland
    Mr. Chairman and Members of the Subcommittee.
    My name is Alan Kliger. I am a kidney specialist, a Clinical 
Professor of Medicine at Yale University School of Medicine, and I am 
Chairman of the Department of Medicine at the Hospital of St. Raphael 
in New Haven, Connecticut. I am an employee of a not-for-profit 
hospital, and am not in the employ of any pharmaceutical manufacturers 
or other commercial enterprises.
    I am currently President of the Renal Physicians Association (RPA), 
the professional organization of nephrologists whose goals are to 
ensure optimal care under the highest standards of medical practice for 
patients with renal disease and related disorders. RPA acts as the 
national representative for physicians engaged in the study and 
management of patients with renal disease. In addition, I am the past 
president of the Forum of ESRD Networks, a national organization of 
regional networks under contract with CMS to promote and oversee 
quality improvement at dialysis and kidney transplant facilities, and 
to ensure access to care for all patients who need dialysis treatments.
    I want to begin by thanking you, Mr. Chairman and Ranking Member 
Camp, first for your leadership on an issue that affects the lives of 
the millions of Americans suffering from kidney disease. Secondly, I 
want to thank you for giving me an opportunity to inform this 
discussion with some perspectives on the issue of anemia management 
that I believe have sometimes been overlooked--those of the front-line 
physicians who are actually treating patients suffering from kidney 
disease and kidney failure.
    This is a complex issue. I know because for more than 15 years RPA 
has been directly involved in helping to develop evidence-based 
clinical practice guidelines, based on systematic reviews of the 
published evidence. In fact, I served on the steering committee of the 
National Kidney Foundation's Kidney Disease Outcomes Quality 
Initiative, or KDOQI, which was charged with developing guidelines for 
dialysis patient care, including anemia management. I also participated 
in the development of 16 clinical performance measures designed to 
measure what doctors actually do, give them feedback, and help them 
refine their practices to reflect what works best. The dividends we saw 
from that effort included an improvement in the quality of care as well 
as documented evidence of better adherence to practice guidelines.
Clinical Practice Guidelines and Physician Prescribing Autonomy
    RPA believes that clinical practice guidelines in renal care, like 
those in other medical disciplines, should be evaluated on the basis of 
the strength of evidence, an assessment of harms and benefits, and 
should benefit from robust physician and other multidisciplinary input 
and review. Guidelines developed with these considerations in mind can 
only enhance the delivery of high quality patient care and help ensure 
kidney patient safety. RPA also believes that the current body of 
literature in the area of anemia management fulfills these criteria, 
and forms a solid foundation for public policy making efforts such as 
the Centers for Medicare and Medicaid Services (CMS) EPO Monitoring 
Policy (EMP). Further, it is our opinion that the CHOIR and CREATE 
studies published in the New England Journal of Medicine last year, 
once subjected to the full measure of robust scientific review, will 
likely represent an important addition to this already significant body 
of literature, and should be considered thoughtfully and thoroughly by 
care providers and policymakers.
    However, it is important to remember that clinical practice 
guidelines are just that: guidelines, not required protocols. Because 
every patient is unique, when it comes to ESA dosing, each patient must 
be considered individually--not in the aggregate. Clinical decisions 
and prescription choices must be made one patient at a time--based on 
what options provide that patient with the best outcomes possible.
    The most important determining factor in the care of the patient, 
above all, should be the physician's clinical judgment considered in 
the context of the physician-patient relationship. We believe that it 
is of paramount importance to maintain the physician's autonomy and 
ability to exercise clinical judgment in prescribing for the individual 
patient. Decisions for the individual may be different than practice 
guidelines advise because of individual clinical evaluation and 
specific patient needs, taking into account a wide range of factors, 
including the age of the patient and the severity of kidney disease. 
This is a fundamental and well-recognized clinical principle in 
medicine, and it is mandatory that it be maintained and protected. RPA 
believes the CMS' EPO Monitoring Policy accounts for such use of the 
physician's clinical judgment.
    Variability in ESRD Patient Hemoglobin Levels
    Recent studies warn that kidney failure patients should not have 
high blood counts, noting that a group of patients with high blood 
counts in general carried a higher risk than patients with lower blood 
counts. But my experience with one of my patients shows how patient-
centered care sometimes should deviate from guideline-advised care. I 
have a 52-year-old patient who is in kidney failure. When his blood 
count is less than 36 percent, he feels tired and washed out and 
experiences chest pain. When EPO raises his blood count to 38 percent, 
he feels like a healthy man; he functions better and feels more 
productive. The differences are so prominent to him that he tells me 
what his blood count is before I have a chance to measure it. For this 
particular patient, a higher blood count is what he needs in order to 
function normally. My patient knows that the recent studies warn about 
the long-term side effects of these higher blood counts, but he also 
knows he needs these levels to function normally. His choice and mine 
for enough EPO to maintain higher blood counts is the right choice.
    RPA believes that in the recent discourse on national coverage of 
EPO, the critical issue of variability of individual patient response 
to EPO dose has been understated. As we have noted in correspondence to 
CMS, attempts to assess or quantify individual sensitivities (i.e. 
responsiveness) to EPO at a narrow level have not been successful. 
Therefore, there is no single, predictable response to a given dose of 
EPO, a fact that accounts for the wide range in individual responses to 
treatment. As a result, in the aggregate it is physiologically not 
rational to tailor a normal distribution of patient responses to a 
payment limit: such a paradigm cannot be successful in delivering 
optimal treatment with sophisticated agents to complicated patients. 
Payment limits structured in this fashion place emphasis on the wrong 
arm of therapy: emphasis should be placed rather on reducing the number 
of patients with low hematocrits/hemoglobins (>30%/10 gm/dL). At the 
same time, Medical coverage policy should strive to maintain levels in 
all patients > 11 gm/dL, given the ample data disclosing the adverse 
short and long-term effects to patients with persistent anemia. Simply 
put, overemphasis on monitoring patients at the upper end of the range 
should not create problems for patients at the lower end, and RPA 
believes that the current CMS EPO Monitoring Policy strives to avoid 
such problems in the broad Medicare ESRD beneficiary population.
Misperceptions Regarding EPO Reimbursement
    Finally, RPA would also like to take this opportunity to dispel 
some common misperceptions regarding reimbursement for erythropoietin. 
There have been articles in both the mainstream and medical trade press 
implying that nephrologists have a financial incentive to prescribe 
higher doses of erythropoietin to ESRD patients. This is simply not 
true. Nephrologists prescribe EPO based on their clinical judgment of 
what will optimize the individual patient's hemoglobin level. Moreover, 
it is the dialysis facility that receives reimbursement for EPO 
prescribed to ESRD patients, not the nephrologist. Any inference that 
the nephrologist will personally benefit from prescribing higher doses 
of EPO, or any drug, to ESRD patients is flat wrong.
Conclusion
    In conclusion, RPA supports the use of clinical practice guidelines 
in the development of protocols enhancing the delivery of high quality 
patient care, but believes they must be considered in the context of 
the physician's clinical judgment. RPA believes that physician 
prescribing autonomy must be maintained, and that the variability in 
ESRD patient hemoglobin levels must be taken into account in the 
development of national coverage policy for EPO.
    As always, RPA stands ready to serve as a resource as the Committee 
works to ensure the best possible health outcomes and quality of life 
for Medicare beneficiaries with ESRD. (Check this out)

                                 

    Chairman STARK. Thank you. I agree with you, Dr. Kliger, it 
seems quite obvious that the physician should establish a 
protocol for each individual patient, variations. But what 
about physicians who sign standing orders with the two big--
with DaVita and Fresenius? Is that--do you approve of that?
    Dr. KLIGER. The standing orders, as I understand them, 
largely were established according to the evidence-based 
guidelines that came down from the original KDOQI plan. But I 
certainly agree with you that signing on to something that is 
set up somehow outside of a physician's judgment is not 
appropriate.
    Physicians are responsible for all of the orders they sign. 
The algorithms of care that some of the chains have, and in 
fact some of the drug companies have as well, were done 
according to the recommendations of the guidelines and were 
meant to be an aid to physicians in making the best 
prescriptions. But I surely agree with you that in the final 
analysis, it is the physician who has that responsibility.
    Chairman STARK. Dr. Singh, you've talked about the 
differences in management practices in two dialysis chains, 
really what we're talking about this morning. Can you comment 
on what--how you observe these practices and whether--what's 
beneficial and what's harmful?
    Dr. SINGH. Chairman Stark, generally what happens in 
dialysis chains is that there are centralized corporate 
Committees that take into account some of the prevailing 
guidelines as well as some opinions of their own individual 
medical directors, as well as corporate staff, and formulate 
guidelines for anemia management. These guidelines generally 
get translated into standing orders, which is signed off 
frequently by the medical director of a dialysis facility and 
then subsequently monitored at many dialysis facilities by an 
anemia nurse.
    Different dialysis chains have different ways to put 
together these guidelines, and these guidelines differ from one 
chain to the other. If you look at the dialysis guidelines with 
regard to ESAs at DCI, a not-for-profit facility, the company 
gives medical directors a lot of autonomy in deciding what they 
should be doing in their own patients. So, for example, in our 
DCI unit, we hold EPO at hemoglobin levels above 12 grams per 
deciliter. We do not give EPO. We discontinue it at that level 
or higher.
    In contrast, for example, in the DaVita chain, the 
corporate guidelines say that hemoglobin levels can--certainly 
should be targeted between 11 to 12 grams, but that there is 
only a 10-percent reduction in EPO when the hemoglobin level 
exceeds 13 grams. So there is tremendous variability between 
different chains and what is in the standing orders between 
different chains.
    My own perspective is exactly the same as actually Dr. 
Kliger's, that dialysis physicians need to be able to 
individualize the anemia management for their patients, because 
patients are different. And I think that there have been some 
unfortunate consequences of instituting standing orders and 
these rather restrictive guidelines with respect to anemia in 
terms of the hemoglobin levels that are achieved, and I think 
in part explains why hemoglobin levels and EPO doses at the 
DaVita units, for example, as shown by Dr. Cotter's research, 
are much higher than in DCI, which is much lower.
    Chairman STARK. Okay. Let me try this. In Southern 
California, Kaiser contracts with Fresenius, okay. Same centers 
that other people walk into that Medicare may be paying for 
directly. But Kaiser has--first of all, it requires 
"subcutaneous'', and also it has their own guidelines in terms 
of dosage and monitoring. And I don't know that anybody's ever 
complained, and I'd ask any of you, that theirs is lower 
quality. As a matter of fact, I suspect it's rather high 
quality. And they're saving a couple of grand, two, three, four 
grand per patient per year, with a bundled payment.
    Now, help me there. Why is what Kaiser is doing bad? Dr. 
Kliger?
    Dr. KLIGER. I wouldn't characterize it as bad.
    Chairman STARK. No, and it saves money.
    Dr. KLIGER. Right. You know, first of all----
    Chairman STARK. Okay. But then--now help me. I look at that 
and say, well, why couldn't we do that? Assuming some very 
strict assumptions. I have a hunch that Kaiser may do its own 
monitoring. So it has its own quality standards. Maybe they're 
the same, but they supervise it perhaps more closely than some 
Medicare intermediary might. Item one.
    Two, they are willing to vary the payments. Now I'm as a--
people have talked today about, oh, dear me, if we have 
bundling, we will underserve. We'll cut the dosage. Well, that 
hasn't happened in this case, and my guess is we could protect 
against that, and we'd probably get AMGEN's help in designing a 
system that would guarantee we don't under-dose.
    You know, it seems to me, the pendulum, we can overdose or 
under-dose, and we can have financial incentives that push us 
either way, and we shouldn't. We should let you and you decide 
what's best and hit for that standard. Now, I'm going to talk 
to you about the guy with the quality of life, because my 
medical marijuana people would like to enlist your help on this 
idea of quality of life on the same rubric. But--and I 
understand. As I say, a patient feels good. That's an important 
thing, and if the patient understands, and I gather you've said 
that he or she does, whatever risks might be there, and really 
clearly understands them, I think that's great.
    If I could get to one other issue that's come up, the issue 
of basically of minority or non-white patients and the 
difference in treatment. Ms. Robinson, your group and the 
groups--are you representative of the patient population in 
terms of minority members and----
    Ms. ROBINSON. We are. We represent over a million patients 
a year with our services and by our own survey of data, we 
represent the population almost identically to the population 
at large in renal disease.
    Chairman STARK. Dr. Singh, in my district in Alameda 
County, I perhaps have a third of my constituents--40 percent 
are either Asian or Indo-American. I think most of the 
physicians in my district are Indo-American. But is there, as 
our first witness today indicated, for African Americans, are 
there different general characteristics among various ethnic or 
racial groups that you all--between Asian or Native Americans 
or African Americans? Is that----
    Dr. SINGH. With regards to achieving certain quality 
parameters such as anemia management of dialysis adequacy or 
iron management, or vitamin D management, these are important 
complications of kidney failure, there is no evidence that has 
made the compelling case that we should treat certain races 
differently than others.
    Certainly you could argue that we need to investigate more 
and do studies that explore this issue more robustly. But 
there's certainly no evidence that I'm aware of with respect to 
anemia management, for example, that African American 
individuals or individuals of Asian origin should be treated 
differently or to different hemoglobin levels than patients who 
are all white Americans.
    Chairman STARK. Would you agree with that, Dr. Kliger?
    Dr. KLIGER. I surely agree with that. There is one 
interesting study that was published in 2005 looking at the ESA 
requirements for African Americans versus whites was 
interesting in that among the nonsmokers----
    Chairman STARK. Yeah.
    Dr. KLIGER. You had alluded to that before.
    Chairman STARK. Yes.
    Dr. KLIGER. This one study suggest that the dose of ESAs 
required to get to the same hemoglobin level was somewhat 
higher in nonsmoking African Americans.
    Chairman STARK. And it seems to me that kind of a study 
would alert both of you physicians to say, if I have a smoking 
African--can't talk about a smoking, I at least ought to be 
monitoring the dosage levels very closely, because this could 
cause a problem. Is that--I mean, that's the way doctors think, 
I believe.
    Dr. KLIGER. Sure. Sure. And also alert us that it may be 
that those patients might require somewhat higher doses of ESAs 
to get to the same level.
    Dr. SINGH. Can I just add to that? I think it's very 
important to emphasize that there are major limitations with 
observational or retrospective data that emerges with respect 
to kidney disease patients. So, for example, observational data 
had suggested that higher hemoglobins are beneficial to 
patients with kidney disease, and in fact the randomized 
control study showed precisely the opposite.
    So I think before we conclude, based on observational data, 
that one group should be treated differently to another group, 
we really do need to try and get it confirmed in randomized 
control studies, and I think this would be a plea for us to 
actually get more support for funding of research that allows 
us to do these type of investigations.
    Chairman STARK. Agreed. Let me ask if you'd like to 
inquire. Mr. Johnson has been waiting patiently.
    Mr. JOHNSON. Thank you, Mr. Chairman. Dr. Kliger, I 
understand that fluctuations in hemoglobin are fairly common, 
and I think it's important that we try to keep that in mind 
when we make changes. In fact, I've heard the analogy that 
adjusting hemoglobin levels in patients is from my viewpoint 
kind of like landing on an aircraft carrier at night. It's 
tough.
    So you can provide your views as a nephrologist on the 
difficulty of maintaining patients in this range? In addition, 
what are the situations where patients with ESRD could still 
experience temporary excursions above 12?
    Dr. KLIGER. Well, there's always going to be, because of 
the biologic variation in response to the ESAs, there will 
always be a distribution of blood counts, given the same 
overall approach to therapy. So that trying to maintain all 
patients, for example, in the very narrow range between say 11 
and 12 grams percent, would really prove to be very difficult 
or perhaps even impossible. So that the truth is that any 
policy that you make that will tend to stop the upper end 
dangers will also shift the curve toward the left and undergo 
the possibility of more patients with the lower blood panels, 
with the lower hemoglobin levels.
    Because of that variability, we really have to be critical 
in watching the responses, monitoring the responses of our 
patients and acting accordingly. Dr. Singh, of course, is 
right. In fact, as Kris was, that when patients get into those 
upper levels that reducing the does is important, but the 
response to that reduction varies. Some patients stay for a 
longer time at higher levels. Some fold very quickly. It's that 
variability that's really at the heart of the patient-doctor 
decisions about the best care.
    Mr. JOHNSON. Thank you. Ms. Robinson, I think it's 
important to focus on ways to improve the quality of care, as 
I'm sure you do, and there's been a ton of studies on--that 
suggest more frequent dialysis, which is often provided in the 
patient's own home, might significantly reduce the need for EPO 
and other medications.
    Can you tell us how often home dialysis is used by dialysis 
patients and what are the benefits for the patient and what can 
we do to increase the utilization by Medicare?
    Ms. ROBINSON. It's a very small population who are 
currently dialyzing at home, whether that's home hemodialysis 
or----
    Mr. JOHNSON. What kind of percentage would you guess?
    Ms. ROBINSON. Probably less than 10 percent, including 
peritoneal dialysis. But there are a lot of benefits.
    Mr. JOHNSON. But it's a fairly recent thing, too?
    Ms. ROBINSON. It is. Absolutely. The home daily 
hemodialysis is really quite recent. And what patients are 
finding is not only are their outcomes better, but they're 
feeling better. They're able to be--continue with their work. 
They're able to be active in their community. And one of the 
best things is they can dialyze on a schedule that is good for 
them, whether it be when they come home in the evening.
    So they really do have much better outcomes, and they're in 
the hospital less, and they use less medication, and they cost 
less money because they don't use the nursing population as 
much.
    Mr. JOHNSON. Okay. So you're an advocate of that?
    Ms. ROBINSON. I'm a huge advocate, correct.
    Mr. JOHNSON. So am I. So am I.
    Ms. ROBINSON. Thank you.
    Mr. JOHNSON. Dr. Singh, in your testimony last December 
before the Ways and Means Committee, you talked about bundling, 
and there's been a good deal of discussion on that today. The 
difficulties of establishing the proper case mix to account for 
certain patient variability parameters. Have you considered how 
the case mix adjust a bundled payment to avoid unintended 
consequences for small providers and patients?
    Dr. SINGH. Thank you. I continue to believe that there 
needs to be adjustment according to risk and geography for--in 
designing a system, a bundled system of payment, because I 
agree with you that we should not place at risk providers who 
provide care for patients in remote areas, rural areas, or in 
inner city indigent areas where it may or may not be easy to 
treat these patients.
    But I do believe that one can achieve that. One can 
accomplish that by modeling current CMS data. And I was 
interested to hear Ms. Norwalk talking about this, that they 
have in fact developed regression models which adjust for a 
number of these factors to try and accomplish this.
    I think that the best way to do it is to actually implement 
a system, because there are certain limitations with doing 
demonstration projects. Because these demonstration projects 
select different regions or tend to select different regions, I 
think that one needs to implement a system, one needs to have 
an open mind about what that--about adjusting that system to 
handle some of the issues that come out of it.
    But I do think that a key aspect of that will be to adjust 
for factors such as case mix, geography, so that you don't put 
certain people out of business because they happen to provide 
care in an area where it may not be feasible to otherwise 
provide care. And I do believe a system can be designed to 
accomplish that, and I believe--and I was very pleased to hear 
that in fact CMS appears to have accomplished that.
    Mr. JOHNSON. Thank you, sir. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Camp?
    Mr. CAMP. Well, thank you, Mr. Chairman. Thank you all for 
your testimony and for being here today. Dr. Kliger, does 
Medicare currently address either education or prevention 
programs for patients with chronic kidney disease? And how 
should we modify existing programs to ensure that patients 
receive the best care possible?
    Dr. KLIGER. It's a great question. We surely don't have 
sufficient funding for education programs. With so many 
Americans with kidney failure, most of whom don't even know 
that they have it yet, we clearly need to invest more of our 
resources at getting at the roots of renal disease early. 
Educating people into knowing what their number is, knowing 
what their estimated kidney function is. Knowing whether they 
have high blood pressure, knowing whether they have diabetes, 
that they're getting appropriate treatment for each.
    And then for those people who have chronic kidney disease 
and approach the need for dialysis, critically important is the 
education about patient-centered choices, the choices that they 
have about modes of treatment, including home dialysis, home 
peritoneal dialysis, hemodialysis, kidney transplantation.
    So I surely think that we need to do more and that CMS 
should do more to support those.
    Mr. CAMP. We heard Mr. Johnson mention the CMS published 
proposed national coverage decision for the administration of 
ESAs in regard to hemoglobin and hematocrit levels for cancer 
patients with anemia. But you state in your testimony that it's 
paramount to maintain the physicians's autonomy and ability to 
exercise clinical judgment in prescribing for the individual 
patient.
    And from your experience, have you found that dialysis 
facilities disregard physician ESA recommendations on dosing, 
or do they insert their own judgment in those areas?
    Dr. KLIGER. Both physicians and facilities I believe are 
guided by the evidence-based guidelines that have been 
published that use the best evidence that we have to come up 
with algorithms of care. It's not a matter of done independent 
of neither group, neither physicians nor facilities make up 
their own minds or should be making up their own minds about 
that, but rather be utilizing those evidence-based guidelines.
    As new evidence comes along, like Dr. Singh's study, those 
evidence-based guidelines need to be revised, considered but 
continue to be the main source of the authority for both 
facilities and physicians to be making those best decisions.
    Mr. CAMP. And, Ms. Robinson, do you have any comment on the 
new CMS guidelines?
    Ms. ROBINSON. For ESA dosing?
    Mr. CAMP. Yes, for ESA dosing.
    Ms. ROBINSON. We feel very strongly that they should 
coincide with the FDA guidelines for ESA dosing. That's 
extremely important to us. We don't want to see patients under-
dosed or overdosed, but we do want to see them in the 11 to 12 
range, understanding that there is variability and sometimes 
they'll go over.
    Mr. CAMP. Well, aren't those different approaches, one is a 
payment guideline and one is a treatment guideline? Do you see 
those as--you don't see those as different approaches?
    Ms. ROBINSON. Not necessarily, because if there's the 
opportunity to pay at a higher level, then you want to ensure 
that the physician is still dosing with regard to the FDA 
guidelines. So, that, you know, based on the payment policy, 
you'd still want to make sure that the physician isn't dosing 
above 13 for several months.
    Mr. CAMP. Well, given the testimony we heard earlier, it 
may take several months to come down to that level. And so, 
therefore, the reimbursement rate is a bit higher, at least in 
their advisory panel. Either Dr. Singh or Dr. Kliger, do you 
want to comment on that?
    Dr. SINGH. I think that it is true that it does--that you 
cannot immediately see a response when you adjust the dose of 
ESAs, but I think it's remarkable that there are still a fairly 
reasonable number of patients that have persistently elevated 
hemoglobin levels, and that this number seems to have grown 
since the Medicare reimbursement guidelines were changed in 
April 2006.
    So I think that if the intent of the Medicare reimbursement 
guidelines was to reduce people who had hemoglobin levels 
persistently above 13, that hasn't worked, because Ms. Norwalk 
herself in testimony today indicated that the percentage has 
actually increased somewhat. And in fact, in DCI's, our own 
data which we've looked at, the amount has--you know, the 
proportion has gone up since these guidelines were introduced.
    Mr. CAMP. Yes. And, Dr. Kliger, if you could comment. But 
it does seem to me that everything we've heard in terms of 
medicine is about individualizing medicine in the future, and 
if we have a national standard at a certain level, what does 
that do to the individual patient? But Dr. Kliger, I'd like to 
hear your comments.
    Dr. KLIGER. Well, Congressman, I think that your point is 
very well taken. That is that we clearly need to have targets 
of therapy, good clinical guideline targets. But the payment 
policy needs to take into consideration that variation, that 
targets are not hit as a bullseye. Targets are hit in a wider 
range, and the payment policy needs to be there to encourage 
the appropriate use and prevent the harmful effects of the 
medicine, but nonetheless recognize that variability.
    Mr. CAMP. All right. Thank you. I see my time has expired. 
Thank you, Mr. Chairman.
    Chairman STARK. I just wanted to make sure that I emphasize 
that Ms. Robinson, your group supports the use of 
"subcutaneous'' administration?
    Ms. ROBINSON. Yes we do.
    Chairman STARK. There may be cases when that's not called 
for by the physician.
    Ms. ROBINSON. Right.
    Chairman STARK. But in general, you don't have an 
objection?
    Ms. ROBINSON. We do. When we surveyed patients, they were 
willing to do it, overwhelmingly willing to do ``subcut''. If 
they understood from their physician in a discussion why it was 
more effective, which it is, why it might be cost efficient and 
how they'll have better outcomes overall. So, yes.
    Chairman STARK. And you support bundled payments but also 
strong review of--to ensure quality if we are involved?
    Ms. ROBINSON. Absolutely. And also to ensure that patients 
aren't discriminated against by facilities because they may be 
sicker patients.
    Chairman STARK. Okay. If I can digress for a minute, Dr. 
Kliger, you had suggested that we want to educate and be alert 
to the causes of kidney problems. Do you think--and Dr. Singh 
can--that those of us who are on various cholesterol-lowering 
medicine are reasonably alerted to the fact that in some cases, 
that could cause kidney problems? Do you think in general that 
we are--those of us who are trying to keep our cholesterol down 
using these drugs, knowing that in some cases they can cause 
kidney problems. Is there enough information abroad in the 
land?
    Dr. SINGH. I think certainly one of the issues that we do 
rely on is the FDA to try and alert us, because they have a 
very--a good system of--a Medwatch system that allows us--the 
FDA to monitor side effects after post-marketing of a drug. And 
there were reports that in fact there was some concerns with 
regards to certain statin or a certain statin agent that might 
be associated with increased risk. However, I feel that the 
systems that we have in place currently are good at at least 
detecting these issues.
    I think the much more challenging issue is, once you detect 
this, what does the FDA do about it? And I think that that's 
something that has been addressed most recently by the 
Institute of Medicine. That's something that I think the 
Congress is also considering whether to empower the FDA to deal 
with this in different ways.
    I think that's even germane to the ESA issue. The first 
study on ESA safety was published in 1998 in the New England 
Journal, showing increased risk in dialysis patients, and we 
are 9 years later, and we're debating this issue when the first 
study showing increased risk was over, you know, was 9 years 
ago. So I do think that, you know, post-marketing surveillance 
is important, whether it's important for statins, as you 
suggest, or it's important for ESAs. And I think we should rely 
on Federal agencies such as the FDA adequately empowered to 
work on our behalf to make sure that patients are kept safe.
    Chairman STARK. Are you comfortable with that, Dr. Kliger?
    Dr. KLIGER. Yeah, I surely agree. I guess one of the things 
that it points out is really how complex this is. Because what 
you have is confounding of people with heart disease, high 
cholesterol, those other things, all of which predispose to 
kidney disease and kidney failure. And understanding and 
sorting out what is a side effect of a medicine or a result of 
the complex medical conditions can be very difficult.
    Chairman STARK. Okay. Let me digress one more time while I 
have two nephrologists here. You both are familiar with AIDS 
treatment, right? We had some testimony not so long ago that in 
the Part D program, some of the providers, the benefit 
providers, are in effect discriminating against the anti-
retroviral drugs, and either they're raising the price or not 
being too excited about enrolling patients with AIDS.
    Should we not, in your opinion, in any of our 
pharmaceutical programs, make sure that these anti-retroviral 
drugs are available to AIDS patients? Is there any reason we 
shouldn't?
    Dr. KLIGER. Yes, sir. I agree with you.
    Chairman STARK. Okay.
    Dr. SINGH. I agree with you.
    Chairman STARK. One more. And you may not agree to this 
one. Are we close, and could you make a case, and if there's 
any research, let me know, that perhaps we ought to treat HIV 
in terms of how we pay for it the same way we do end-stage 
renal disease?
    Dr. KLIGER. You're not going to get an easy answer from me. 
I'd have to think about it, what you mean by that and how----
    Chairman STARK. Well, it's a disabling disease. It's the 
only, if you will, socialized medicine that we have in this 
country. End-stage renal disease, young, old, the government 
pays for it, right? I mean, there's a little bit of private 
insurance at the beginning, but basically, it's the only thing 
I know of that we pay for universally.
    Should--can you make a case that it would be good both 
social and economic, and/or economic policy? And you may not 
know. I'd love to hear your opinion, that we ought to include 
HIV patients and treat them in the same way? Not necessarily 
under the ESRD, but that if you've got it, your insurance may 
cover it for a year or two and then we pay for it in a 
Federally funded program?
    Dr. SINGH. Chairman Stark, I would suggest to you that in 
fact the Federal support for the ESRD program is really a 
beacon of what can and should be considered for a number of 
conditions where groups of patients are affected. I think that 
it's been an absolutely huge success that the government has 
paid for dialysis and related services in patients, and I think 
that it just shows that it can be done. And I think if you are 
arguing that HIV is a condition, like many other conditions, 
chronic diseases, where it's very difficult to get support from 
either private insurers or to get help if you're uninsured. And 
I do think that the Federal Government has an example in ESRD 
where it can be done, and it can be done successful, you know, 
not withstanding tweaking that needs to be done, of course.
    But it's been a hugely successful program in terms of its 
achievement of quality, where I think--tell me a program where 
the government pays for it and there's people, you know, there 
are quality measures and there's attempts by large numbers of 
doctors and providers to try and achieve quality parameters in 
patients. I think it's just an inspiring example of what can be 
done.
    Dr. KLIGER. Well, actually, you know, as a physician, I'd 
love to see HIV underwritten and supported for all. I'd like to 
see diabetes underwritten and supported for all. I'd like to 
see hypertension underwritten and supported for all. So the 
truth is, of course, as an advocate of my patients, I tell you 
guys here on Capitol Hill, you bet. That's what I'd want. But, 
obviously, the practical question then is where do you really 
draw the line and how do you know how to best invest the 
limited resources that we have?
    Chairman STARK. Thank you. Thank you very much. If there 
are no further comments or questions, I want to again thank the 
panel for their participation and patience. You've been very 
helpful. And the hearing is adjourned.
    [Whereupon, at 1:05 p.m., the Subcommittee was adjourned.]
    [Submissions for the record]
                           Statement of Amgen
    Amgen is pleased to submit this written testimony for the record 
with regard to the use of Erythropoiesis-Stimulating Agents (ESAs) in 
Medicare beneficiaries with End-Stage Renal Disease (ESRD).
    Amgen has pioneered the development of innovative medicines--ESAs--
that safely and effectively treat anemia when used according to the 
U.S. Food and Drug Administration (FDA)-approved prescribing 
information. EPOGEN' (Epoetin alfa) is an ESA developed by 
Amgen scientists using recombinant DNA technology which has the same 
biological effects as naturally occurring erythropoietin. Nearly every 
patient with ESRD does not produce adequate amounts of erythropoietin, 
and consequently suffers from anemia (lack of red blood cells). 
EPOGEN' has been shown to increase hemoglobin levels (amount 
of red blood cells) and reduce the need for red blood cell 
transfusions; indeed the development of EPOGEN' as a 
therapeutic has been hailed as one of the major breakthroughs in 
treatment for dialysis patients.
    Over recent months, new clinical trials published in November 2006 
have raised important questions regarding the safe and appropriate use 
of ESAs in patients with kidney disease. These questions primarily 
arose from two studies conducted in non-dialysis patients with kidney 
disease,\1\ and were also influenced by an earlier study, the Normal 
Hematocrit Cardiac Trial (NHCT) published in 1998, that was conducted 
in hemodialysis patients with pre-existing chronic heart failure or 
ischemic heart disease.\2\
---------------------------------------------------------------------------
    \1\ Singh AK, Szczech L, Tang KL, et al. Correction of anemia with 
epoetin alfa in chronic kidney disease. N Engl J Med. 2006;355:2085-98; 
Drueke TB, Locatelli F, Clyne N, et al, for the CREATE Investigators. 
Normalization of hemoglobin level in patients with chronic kidney 
disease and anemia. N Engl J Med. 2006;355:2071-84.
    \2\ Besarab A, Bolton WK, Browne JK, et al. The effects of normal 
as compared with low hematocrit values in patients with cardiac disease 
who are receiving hemodialysis and epoetin. N Engl J Med. 
1998;339(9):584-90.
---------------------------------------------------------------------------
    It is important to note that all three of these studies evaluated 
ESAs when used to target hemoglobin levels that are higher than those 
recommended in the FDA-approved product labels.
    Additionally, several recent oncology studies highlighted important 
potential safety risks of ESAs when used in off-label and experimental 
conditions--related to the potential for tumor progression and 
decreased survival. These issues are not directly relevant to dialysis 
patients who receive ESAs as physiologic replacement therapy, a very 
different situation that in cancer patients receiving cytotoxic 
chemotherapy.
    On March 9, 2007, the FDA and Amgen announced that a black box 
safety warning was being added to all ESA labels, including new 
guidance for dosing and administration. Amgen immediately sent letters 
to all prescribing physicians and directed our professional staff to 
communicate these changes in full to prescribers. Amgen also sent 
letters to all physician prescribers in November 2006 communicating the 
results of two recent studies in non-dialysis patients with kidney 
disease.
    These important safety issues will be discussed at a joint meeting 
of the FDA Cardiovascular and Renal Drug Advisory Committee and the 
Drug Safety Advisory Committee in September.
    Amgen is committed to ensuring that our ESA medications are used in 
the most safe and effective manner. Amgen takes the recent questions 
that have arisen based on the results of the clinical trials conducted 
in patients with kidney disease not on dialysis targeting hemoglobin 
levels above 13 g/dL very seriously, and has undertaken a thorough 
review of all available clinical evidence. We appreciate this 
opportunity to comment on these important questions about the safe and 
appropriate utilization of ESAs in ESRD in this written testimony.
THE BENEFITS OF EPOGEN' AND ANEMIA THERAPY IN ESRD
    EPOGEN' has revolutionized the treatment of anemia in 
dialysis patients, while virtually eliminating the need for red blood 
transfusions that compromise the potential for subsequent successful 
kidney transplantation.
    Anemia affects approximately 9 out of every 10 dialysis patients, 
and is a consequence of reduced production of the hormone 
erythropoietin by the kidney. ESRD patients with anemia can suffer from 
fatigue and weakness. Dialysis patients with anemia are at 
significantly higher risk for cardiovascular events, such as heart 
attack or stroke, and are more likely to die than dialysis patients 
without anemia. Anemia, defined as a hemoglobin concentration below 11 
g/dL, is associated with increased risk of hospitalization and death. 
As a result of this increased risk for hospitalization, Medicare 
beneficiaries with hemoglobin concentrations less than 11 g/dL incur 
higher costs and healthcare utilization: Collins et al demonstrated 
that Medicare member-per-month expenditures for patients with 
hematocrit values 30% to > 33% (hemoglobin 10 to > 11 g/dL) were 10.6% 
higher than for patients with hematocrit values 33% to > 36% 
(hemoglobin 11 to > 12 g/dL).\3\
---------------------------------------------------------------------------
    \3\ Collins AJ, Li S, St Peter W, et al. Death, hospitalization, 
and economic associations among incident hemodialysis patients with 
hematocrit values of 36 to 39%. J Am Soc Nephrol. 2001;12(11):2465-73.
---------------------------------------------------------------------------
    Before the availability of EPOGEN' more than a decade 
and a half ago, physicians had few options for treating anemia in 
dialysis patients, and had to rely on blood transfusions. 
Unfortunately, blood transfusions put patients at risk for 
complications such as blood-borne infections, iron overload, and 
antibody responses that limit the chances for a successful kidney 
transplant.
    EPOGEN', a genetically engineered form of 
erythropoietin, has the same biological effect as naturally occurring 
erythropoietin. EPOGEN' dramatically reduces the need for 
red blood cell transfusions. In the EPOGEN' registrational 
clinical trials that targeted hematocrit levels between 32% and 38% 
(hemoglobin 10.7 to 12.7 g/dL), the percentage of patients requiring 
red blood cell transfusions was reduced from 55% at study inception to 
0%-4% following 13-24 weeks of therapy.\4\ When used as directed by the 
FDA-approved package insert, EPOGEN' has been shown to be 
safe and effective in multiple clinical trials, and has over a decade 
and half of safety monitoring in real-world use in almost 1.4 million 
dialysis patients for a total exposure of approximately 3.8 million 
patient-years.
---------------------------------------------------------------------------
    \4\ Amgen data on file.
---------------------------------------------------------------------------
PATIENT SAFETY AND QUALITY OF CARE ISSUES RAISED BY THE COMMITTEE
    The nephrology community consensus is that a hemoglobin target 
range of 11 to 12 g/dL minimizes risk and maximizes benefit in ESRD 
patients, but due to the severity of additional disease burden and 
inherent natural hemoglobin variability, dialysis patients are 
difficult to consistently maintain within this relatively narrow 
hemoglobin range.
    Recently, the National Kidney Foundation's Kidney Disease Outcomes 
Quality Initiative (NKF-KDOQI\TM\) Anemia Working Group reviewed all of 
the published clinical trial data to date. This analysis included the 
two recent trials and the one older trial that have raised these safety 
issues. They examined clinical outcomes associated with higher or lower 
hemoglobin targets including the NHCT in hemodialysis patients with 
chronic heart failure or ischemic heart disease, the Correction of 
Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study, and the 
Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin 
Beta (CREATE) study. Based on this review, the NKF-KDOQITM 
Anemia Work Group recommended that physicians target a hemoglobin in 
the range of 11 to 12 g/dL, and also stipulated that the target not be 
above 13 g/dL.\5\
---------------------------------------------------------------------------
    \5\ National Kidney Foundation-Kidney Disease Outcomes Quality 
Initiative (NKF-KDOQITM). KDOQI clinical practice guideline 
and clinical practice recommendations for anemia in chronic kidney 
disease: 2007 update of haemoglobin. (Draft under review).
---------------------------------------------------------------------------
    It is important to recognize that dialysis patients are seriously 
ill. Seventy percent of patients are on dialysis as a result of 
diabetes and hypertension.\6\ These two conditions are also risk 
factors for cardiovascular disease. Cardiovascular complications are 
endemic in dialysis patients, and account for the high rate of 
morbidity and mortality in this fragile population.\7\ In addition, 
inter-current events such as hospitalization and infection often lead 
to frequent episodes of inflammation, a condition which can 
dramatically decrease an individual patient's responsiveness to ESAs.
---------------------------------------------------------------------------
    \6\ USRDS Annual Data Report 2006.
    \7\ Sarnak MJ. Cardiovascular complications in chronic kidney 
disease. Am J Kidney Dis. 41(S5):S11-S17.
---------------------------------------------------------------------------
    Because of the general poor health status of a typical dialysis 
patient and the natural variability in patient hemoglobin levels, it is 
difficult to consistently maintain hemoglobin within a narrow band such 
as between 11 and 12 g/dL.\8\ Consequently, physicians write anemia 
management protocols to target a specific hemoglobin range with the 
intent of maximizing the number of patients with achieved hemoglobin 
concentrations within this targeted range. However, due to hemoglobin 
variability, patients targeted to a specific hemoglobin range will at 
various times have achieved hemoglobin concentrations that are above 
and below the target at various times.
---------------------------------------------------------------------------
    \8\ Fishbane S and Berns JS. Hemoglobin cycling in hemodialysis 
patients treated with recombinant human erythropoietin. Kidney Intt. 
2005;68(3):1337-43.
---------------------------------------------------------------------------
    Worse patient outcomes such as cardiovascular events or death have 
been consistently shown to be associated with hemoglobin levels below 
11 g/dL compared with temporary excursions above 12 g/dL.
    It is well documented in both domestic and international studies 
that hemoglobin levels of less than 11 g/dL in dialysis patients are 
associated with increased hospitalization, healthcare expenditure, and 
mortality.\9\
---------------------------------------------------------------------------
    \9\ Wolfe RA, Hulbert-Shearon TE, Ashby VB, et al. Improvements in 
dialysis patient mortality are associated with improvements in urea 
reduction ratio and hematocrit, 1999 to 2002. Am J Kidney Dis. 2005 
Jan;45(1):127-35; Locatelli F, Pisoni RL, Combe C, et al. Anemia in 
haemodialysis patients of five European countries: association with 
morbidity and mortality in the Dialysis Outcomes and Practice Patterns 
Study (DOPPS) Nephrol Dial Transplant. 2004 Jan;19(1):121-32; Volkova N 
and Arab L. Evidence-based systematic literature review of hemoglobin/
hematocrit and all-cause mortality in dialysis patients. Am J Kidney 
Dis. 2006 Jan;47(1):24-36; Collins AJ, Li S, St Peter W, et al. Death, 
hospitalization, and economic associations among incident hemodialysis 
patients with hematocrit values of 36 to 39%. J Am Soc Nephrol. 
2001;12(11):2465-73.
---------------------------------------------------------------------------
    In a recent study using United States Renal Data System (USRDS) 
data, Gilbertson et al demonstrated that patients with hemoglobin 
concentrations below 11 g/dL have the greatest risk for adverse 
clinical outcomes, and even transiently low hemoglobin concentrations 
are associated with worse outcomes than transiently high or 
persistently high hemoglobin concentrations above 12.5 g/dL.\10\ Thus, 
these temporary high excursions must not be confused with the risks 
observed with targeting patient hemoglobin levels greater than 13 g/dL 
as was done in both the NHCT study in dialysis patients and the CREATE 
and CHOIR studies in nondialysis patients with kidney disease.
---------------------------------------------------------------------------
    \10\ Gilbertson D, Ebben J, Bradbury B, et al. The effect of 
hemoglobin variability & trends on mortality. American Society of 
Nephrology 39th Annual Scientific Meeting. San Diego, CA. November 14-
19, 2006. Poster SA PO032.
---------------------------------------------------------------------------
    As a result of the numerous analyses demonstrating that achievement 
of hemoglobin levels below 11 g/dL is associated with adverse clinical 
outcomes, physicians strive to achieve maximum benefit by decreasing 
the percentage of patients with hemoglobin levels less than 11 g/dL at 
any time. Furthermore, CMS has independently established the percentage 
of patients with hemoglobin levels above 11 g/dL as a Clinical 
Performance Measure (CPM) for all dialysis clinics, and publishes this 
data on its website. Finally, the community and CMS recognize that when 
striving to achieve hemoglobin levels above 11 g/dL, hemoglobin 
concentrations fluctuate and often exceed the upper bound of the target 
range, temporarily.
    The majority of patients are not being maintained at hemoglobin 
levels above 12 g/dL.
    As discussed above, dialysis patients exhibit extensive variability 
in hemoglobin levels. ESAs are titratable drugs and ESA doses are 
adjusted in response to changes in patient hemoglobin concentrations 
over time in dynamic fashion. Targeting a hemoglobin in a dialysis 
patient is not like setting the cruise control in your car; it involves 
constant monitoring and ESA dose adjustments when hemoglobin values 
fall out of range. A number of studies in dialysis patients have 
provided a cross-sectional, or ``snapshot'', view of hemoglobin 
concentrations for the entire dialysis population showing that at a 
single point in time, 50% of patients may have hemoglobin levels above 
12 g/dL. However, because the majority of these hemoglobin 
concentrations above 12 g/dL are only transient, this snapshot view of 
the data does not accurately describe the natural fluctuations in 
patient hemoglobin levels over time, nor does it capture the consistent 
pattern of physician-directed ESA dose adjustment in response to out of 
target hemoglobin levels. The majority of physicians seek to achieve 
hemoglobin levels of greater than 11 g/dL and less than or equal to 12 
g/dL.
    Due to hemoglobin variability, 90% of patients have hemoglobin 
levels that move from within the recommended targeted hemoglobin range 
(11 to 12 g/dL) to above or below the targeted range over time when the 
data are looked at longitudinally instead of cross-sectionally. This is 
the difference between a ``snapshot'' (cross-sectional point in time) 
versus a ``movie'' (longitudinal view over time).\11\ This critically 
differentiating concept was illustrated by Ebben et al in an analysis 
examining 152,846 patients over a 6 month period in 2003. The study 
found that only 2.0% of patients had hemoglobin levels that were 
persistently maintained at greater than 12.5 g/dL for a six month 
period, but 68.4% of patients had hemoglobin levels that were above 
12.5 g/dL at least once during the same timeframe.\12\ Similarly, Amgen 
has analyzed data and found that 83% of hemoglobin excursions above 12 
g/dL return back below 12g/dL within 3 months.\13\
---------------------------------------------------------------------------
    \11\ Ebben JP, Gilbertson DT, Foley RN, et al. Hemoglobin level 
variability: Associations with comorbidity, intercurrent events, and 
hospitalizations. Clin J Am Soc Nephrol. 2006;1:1205-10; Rubin RJ and 
Mendelson DN. Translating guidelines into policy. Clin J Am Soc 
Nephrol. 2007;2:209-10.
    \12\ Ebben JP, Gilbertson DT, Foley RN, et al. Hemoglobin level 
variability: Associations with comorbidity, intercurrent events, and 
hospitalizations. Clin J Am Soc Nephrol. 2006;1:1205-10.
    \13\ Amgen data on file.
---------------------------------------------------------------------------
    When hemoglobin levels exceed the upper bound, physicians adjust 
ESA doses downward, with the objective of returning hemoglobin levels 
to within target.
    An important finding is that the tendency to decrease ESA doses in 
response to hemoglobin levels being above 12 g/dL has increased as a 
result of recent ESA label changes and the CMS Erythropoietin 
Monitoring Policy (EMP).
    As of April 2007, 81% of hemoglobin excursions above 13 g/dL are 
followed by a dose reduction within 30 days compared to 72% in November 
2005 when the EMP was announced. Data also demonstrate more ESA dose 
reductions occur following hemoglobin excursions between 12 g/dL and 13 
g/dL since the ESA label change was communicated in March 2007. In 
April 2007, 49% of hemoglobin excursions between 12 g/dL and 13 g/dL 
are followed by an ESA dose reduction within 30 days, as compared with 
37% in January of 2007. In addition, in some instances physicians 
implement a dose reduction after 30 days. There is a corresponding 
increase in the number of patients with hemoglobin levels in the 11 to 
12 g/dL range, and the percentage of patients with hemoglobin levels 
above 13 g/dL has declined from 26% in January of 2007 to 23.6% in 
April of 2007.\14\
---------------------------------------------------------------------------
    \14\ Amgen data on file.
---------------------------------------------------------------------------
    Surveillance data from U.S. dialysis patients does not suggest 
evidence of increased mortality when ESAs are a routine component of 
care for dialysis patients.
    Surveillance of nearly 100% of the U.S. ESRD population via the 
USRDS shows that mortality rates have declined since the introduction 
of EPOGEN' (approximately 250 per 1,000 patient years at 
risk in 1989 versus 220 in 2004), coincident with the rise in 
population hemoglobin levels. While not proof of causality, these data 
do not suggest evidence of increased mortality when ESAs are a routine 
component of care for this very fragile dialysis patient 
population.\15\
---------------------------------------------------------------------------
    \15\ USRDS Annual Data Report 2006.
---------------------------------------------------------------------------
    These associations from the entire population level data appear to 
be at odds with correlations of individual patient data. One 
publication has suggested that patients receiving higher ESA doses are 
more likely to die, and has suggested that the high ESA doses cause 
these adverse events.\16\ Similar correlations can be found between 
doctor visits and hospitalizations and death: the more one visits a 
doctor or is hospitalized, the greater the likelihood of death. It does 
not follow, however, that doctors and hospitals cause death. On the 
contrary, it is common sense that those individuals who require 
physician and in-patient care are more likely to die than those who do 
not require medical attention.
---------------------------------------------------------------------------
    \16\ Zhang Y, Thamer M, Stefanik K, et al. Epoetin requirements 
predict mortality in hemodialysis patients. Am J Kidney Dis. 
2004;44:866-76.
---------------------------------------------------------------------------
    This paradox is called ``confounding-by-indication'', and it occurs 
when there is an underlying factor (i.e., being ill) that is associated 
with two parallel outcomes (hospitalization and mortality). Those 
parallel outcomes will then also be correlated: both hospitalization 
and mortality rates increase with more seriously ill patients. A 
similar effect can be seen in the association between ESA dose and 
mortality. Dialysis patients who are relatively more ill have lower 
hemoglobin levels and may be relatively less responsive to ESAs, and 
thus physicians prescribe higher ESA doses in the attempt to achieve 
target hemoglobin levels. However, these relatively more ill dialysis 
patients are simultaneously more likely to die in addition to receiving 
higher ESA doses. This does not provide conclusive evidence that higher 
ESA doses cause increased mortality.
    Fortunately, specific analytical methods have been developed to 
address the epidemiological problem of confounding-by-indication. They 
adjust for the degree of underlying illness in the population. When 
these appropriate techniques are applied to dialysis patients, they do 
not reveal an association between higher ESA doses and increased 
mortality. In fact, these adjusted analyses demonstrate that the 
achieved hemoglobin is a stronger predictor of better or worse outcome 
than is the ESA dose administered.
    While there does not appear to be a causal relationship between ESA 
dose and mortality, Amgen recognizes that there remain unanswered 
questions regarding hemoglobin and ESA dose, especially in patients who 
require high doses of ESAs to achieve modest increases in hemoglobin 
(i.e., hyporesponsive patients). Amgen is evaluating ESA therapy in 
hyporesponsive patients based on all available data and is updating the 
FDA in an ongoing manner regarding the insights and findings. We are 
also informing CMS and the renal community on our findings.
PAYMENT POLICY ISSUES RAISED BY THE COMMITTEE
    ESA doses have increased in the U.S. in concert with substantial 
improvements in the quality of care, growth in the ESRD population, 
increased comorbidity burden, and increased racial disparities in 
ESRD--not due to inappropriate physician utilization or financial 
incentives.
    Medicare spending, as well as doses of EPOGEN' 
administered to U.S. dialysis patients, has increased since the 
introduction of this life-changing therapy due to four primary factors:

      Improvement in hemoglobin outcomes--According to the 
USRDS 2006 Annual Data Report and the CMS 2005 Annual Report for the 
ESRD Clinical Performance Measures Project, the percentage of patients 
with hemoglobin concentrations below 11 g/dL has decreased from 84% in 
1991 to 17% in 2004.\17\ This is a remarkable achievement by the 
nephrology community and a benefit to patients.
---------------------------------------------------------------------------
    \17\ USRDS 2006 Annual Data Report, CMS' 2005 Annual Report ESRD 
Clinical Performance Measures Project.
---------------------------------------------------------------------------
      Comorbidity burden--The percentage of ESRD patients with 
diabetes has increased over time from 59% to 66% in whites and from 
60.6% to 66.3% in blacks respectively from 1995 to 2004. It has been 
observed that diabetic patients and patients with other comorbidities 
often require higher ESA doses.\18\
---------------------------------------------------------------------------
    \18\ USRDS 2006 Annual Data Report; Barany P, Divino Filho JC, 
Bergstorm J. High C-reactive protein is a strong predictor of 
resistance to erythropoietin in hemodialysis patients. Am J Kidney Dis. 
1997;29(4):565-8; Del Vecchio L, Pozzoni P, Andrulli S, et al. 
Inflammation and resistance to treatment with recombinant human 
erythropoietin. J Ren Nutr. 2005;15(1):137-41; Hsu SP, Peng YS, Pai MF, 
et al. Influence of relative hypoparathyroidism on the responsiveness 
to recombinant human erythropoietin in hemodialysis patients. Blood 
Purif. 2003;21(3):220-4; Ifudu O. Patient characteristics determining 
rHuEPO dose requirements. Nephrol Dial Transplant. 2002;17(Suppl5):38-
41.
---------------------------------------------------------------------------
      Increased racial disparities--Racial minorities are also 
disproportionately represented in the ESRD population and this trend 
has increased over time: approximately one-third are African-American, 
and 1 in 7 are Hispanic. African-Americans in particular receive higher 
ESA doses to achieve similar hemoglobin levels as other patient 
subgroups.\19\
---------------------------------------------------------------------------
    \19\ USRDS 2006 Annual Data Report.
---------------------------------------------------------------------------
      Growth in the number of patients on dialysis--USRDS 
reports that prevalent dialysis patients have more than doubled since 
1988. This growth in dialysis patients means that more patients require 
treatment which increases Medicare spending.\20\
---------------------------------------------------------------------------
    \20\ USRDS 2006 Annual Data Report.
---------------------------------------------------------------------------
      A recent article in the New York Times indicated that ESA 
doses in the U.S. are twice that observed in Europe.\21\ However, the 
article did not describe the achieved hemoglobin levels in the U.S. 
compared with EU countries, or other differences in the U.S. and EU 
patient populations that impact ESA dose requirements.
---------------------------------------------------------------------------
    \21\ Berenson and Pollack The New York Times, May 9, 2007.
---------------------------------------------------------------------------
      The U.S. had the second highest hemoglobin level, a 
marker of quality care, of all the countries studied (the best 
hemoglobin outcome was observed in Sweden, which had the second highest 
unadjusted mean ESA dose).\22\
---------------------------------------------------------------------------
    \22\ Pisoni RL, Bragg-Gresham JL, Young EW, et al. Anemia 
management and outcomes from 12 countries in the dialysis outcomes and 
practice patterns study (DOPPS). Am J Kidney Dis. 2004;44(1):94-111.
---------------------------------------------------------------------------
      The differences in ESA dose across world regions can be 
explained in part by differences in patient comorbidities, race, and 
dialysis vascular access type.\23\ This has been shown in the Dialysis 
Outcomes and Practice Patterns Study (DOPPS), the largest global 
registry of dialysis patients.
---------------------------------------------------------------------------
    \23\ Goodkin DA, Bragg-Gresham JL, Koenig KG, et al. Association of 
comorbid conditions and mortality in hemodialysis patients in Europe, 
Japan, and the United States: The Dialysis Outcomes and Practice 
Patterns Study (DOPPS). J Am Soc Nephrol 14:3270-3277, 2003; Pisoni RL, 
Young EW, Dykstra DM, et al. Vascular access use in Europe and the 
United States: Results from the DOPPS. Kidney Int 61:305-316, 2002.

    The most recent data suggests that ESA doses are stabilizing. The 
Medicare Payment Advisory Commission (MedPAC) indicated in its March 
2007 Report to Congress that there has been a 0.6% decline in the 
EPOGEN'dose from 2004 to 2005.\24\
---------------------------------------------------------------------------
    \24\ Medicare Payment Advisory Commission. Report to the Congress: 
Medicare Payment Policy. March 2007.
---------------------------------------------------------------------------
    Current Medicare payment policy for ESRD drugs, average sales price 
(ASP) + 6%, has reduced Medicare expenditures for ESRD drugs in 
general, and for ESAs specifically, thereby minimizing incentives for 
ESA overutilization.
    As already discussed above, the evidence demonstrates that most ESA 
dosing decisions are appropriate; i.e., ESA doses are adjusted up or 
down in response to out-of-target hemoglobin levels, and there is no 
compelling evidence of inappropriate utilization. However, the 
announcement for this hearing suggested the existing Medicare system 
may incentivize overutilization of ESAs, at higher costs to taxpayers 
and risk to patients. The data suggest otherwise.
    In fact, Medicare spending on ESRD drugs has been reduced under the 
ASP+6% system. According to MedPAC in its March 2007 report to 
Congress, the use of the ASP+6% methodology lowered Medicare payment 
for ESRD drugs by about 10% from 2004 to 2005 (a $300 million 
reduction) and shifted drug profits to the dialysis add-on payment.\25\
---------------------------------------------------------------------------
    \25\ Medicare Payment Advisory Commission. Report to the Congress: 
Medicare Payment Policy. March 2007.
---------------------------------------------------------------------------
    The Medicare per unit payment limit for EPOGEN'also has 
decreased under the ASP+6% system, declining almost 7% since ASP-based 
reimbursement was instituted (Q4 2005 versus Q3 2007). Furthermore, 
while MedPAC did not provide a dollar amount for total Medicare 
EPOGEN' spending in its 2007 March report to Congress, 
figures included in the report show a slight decline in total 
EPOGEN' spending between 2004 and 2005.
    Changes to ESRD drug reimbursement from the ASP+6% methodology may 
result in serious unintended consequences to specific dialysis 
populations, in particular those patients that are treated by smaller, 
independent dialysis facilities, including in rural areas and centers 
located in underserved urban areas. Small dialysis providers may just 
be breaking even on ASP+6% reimbursement. ASP is a weighted average of 
all prices and the Department of Health and Human Services Office of 
the Inspector General has found that smaller providers have higher drug 
acquisition prices than larger providers.\26\ If the payment rate were 
changed or lowered, smaller dialysis facilities may lose money in an 
effort to provide needed drugs to their patients, potentially forcing 
these facilities to close and inhibiting sustained access to quality 
care for dialysis patients nationwide.
---------------------------------------------------------------------------
    \26\ Department of Health and Human Services Office of the 
Inspector General. Medicare Reimbursement for Existing End stage Renal 
disease Drugs. May 2004. OEI 03-04-00120.
---------------------------------------------------------------------------
    New analyses of ESA utilization data since the FDA updated the ESA 
labels in March 2007 reinforce the recommendation that a change in the 
EMP is not necessary at this time.
    CMS developed the EMP after several years of extensive deliberation 
and consultation with the nephrology community. CMS and the nephrology 
community have long recognized the need for CMS ESA payment policies in 
ESRD to account for the temporary fluctuations of hemoglobin levels 
that commonly occur. When physicians target hemoglobin levels between 
10 g/dL and 12 g/dL (consistent with the prior FDA-approved label 
hemoglobin target), the majority of those patients--even those on a 
stable dose of EPOGEN'--can experience temporary elevations 
above 12 g/dL, as discussed earlier.
    Prior to the implementation of the EMP, analyses demonstrated that 
ESA dosing decisions were generally consistent with the FDA-approved 
product labels. Although patients may have temporary excursions above 
12 g/dL, 83% of hemoglobin concentrations above 12 g/dL return below 12 
g/dL within three months, and thus it does not appear that physicians 
are maintaining patient hemoglobin levels persistently above 12 g/
dL.\27\
---------------------------------------------------------------------------
    \27\ Amgen data on file.
---------------------------------------------------------------------------
    Early results post-EMP implementation demonstrate stability of 
population hemoglobin levels and ESA doses.\28\ Amgen analysis of data 
collected since the EMP implementation suggests that 81% of physicians 
are reducing ESA doses within 30 days when hemoglobin exceeds 13 g/dL, 
compared to 72% at the time the EMP was announced in November 2005.\29\
---------------------------------------------------------------------------
    \28\ Ofsthun NJ and Lazarus JM. Impact of the change in CMS billing 
rules for erythropoietin on haemoglobin outcomes in dialysis patients. 
Blood Purif. 2007;25:31-5; Amgen data on file.
    \29\ Amgen data on file.
---------------------------------------------------------------------------
    Additionally, newly analyzed data collected following the recent 
ESA label changes show the percentage of patients with hemoglobin 
concentrations above 13 g/dL has been reduced with a corresponding 
increase in the number of patients in the 11 to 12 g/dL range, and 
there is an increased frequency of ESA dose decreases made in response 
to achieved hemoglobin between 12 and 13 g/dL, as well as above 13 g/
dL. As of April 2007, 49% of hemoglobin excursions between 12 g/dL and 
13 g/dL are followed by an ESA dose reduction within 30 days, as 
compared with 37% in January of 2007.\30\ In addition, in some 
instances physicians implement a dose reduction after 30 days. We 
anticipate that additional changes to physician ESA prescribing trends 
will continue.
---------------------------------------------------------------------------
    \30\ Amgen data on file.
---------------------------------------------------------------------------
    Payment changes for ESAs in ESRD based on an insufficient analysis 
of scientific data could lead to negative outcomes for patients and for 
health care in the U.S.
    Amgen believes that any change to the ESRD payment system should 
have a strong policy or clinical rationale, and any new system should 
maintain patient quality of care, ensure patient access, and be 
financially viable for dialysis providers, patients, and taxpayers. As 
this document describes, there does not appear to be a compelling 
policy or clinical rationale to make fundamental changes to the ESRD 
payment system based on the best available scientific evidence and 
utilization data. Congress should carefully consider the potential for 
negative patient outcomes as an unintended consequence of payment 
changes that are not carefully designed, considered, and implemented.
    Accordingly, Amgen does not believe that Congress should consider 
implementing a single bundled payment for drugs and dialysis services 
in dialysis until the Medicare Prescription Drug, Modernization, and 
Improvement Act (MMA) mandated CMS demonstration project to test a 
bundled payment in ESRD is completed. As bundled payment systems create 
powerful financial incentives to save money by underutilizing and 
withholding needed medical services, bundling methodologies must be 
balanced by a robust and clinically valid risk-adjustment system, as 
well as an agreed-upon set of quality safeguards, lest they result in 
the under-treatment of vulnerable dialysis patients. In particular, 
there may be serious unintended consequences to specific dialysis 
populations, such as those residing in rural areas and those receiving 
dialysis care in centers located in underserved urban areas from 
independent dialysis centers. Ultimately, if there is under-treatment 
of dialysis patients, not only would dialysis patients be harmed, it 
could cost taxpayers more money in hospitalizations and other patient 
care expenses. Congress recognized these complex issues, and mandated 
the conduct of a demonstration project before implementing a bundled 
dialysis and drug payment rate.
    ESRD patients represent a seriously ill and vulnerable patient 
group, at high risk of death, with minorities disproportionately 
represented. Even among ESRD patients, there are some who are more 
gravely ill and require significantly greater health care intervention. 
Unless Medicare appropriately reimburses for these patients, even one 
or two such patients in a single dialysis center can literally ``tip 
the scales'' and cause a provider to lose money and even risk closure. 
Many believe that the risk is highest for the small dialysis 
organizations that serve poor patients in rural areas.
    Other changes to ESA reimbursement policy could also have serious 
consequences for patients and providers. Changes to ASP+6% 
reimbursement, a system that has reduced spending and saved taxpayer 
dollars, could in particular harm smaller dialysis providers and the 
patients they service. Changes that mandate specific physician 
treatment decisions, such as mandating a particular ESA route of 
administration, also should be avoided.
    Any of these changes could lead to unintended consequences 
including:

      Poorer quality of care, as dialysis providers may need to 
make compromises to offset lower overall reimbursement.
      Higher overall Medicare costs as a result of poor quality 
dialysis care.
      Threats to access to quality care for patients treated in 
small dialysis facilities in both rural and underserved urban areas. 
Small clinics may begin to avoid more ill/costlier patients in order to 
control costs, or even close as a result of financial burden.

    Finally, given the evolving data on physician prescribing of ESAs 
since the announcement of the revised FDA product labels and 
implementation of the EMP, it may inappropriate for Congress to 
implement new legislation or direct CMS to alter the existing 
reimbursement paradigm for ESAs prior to allowing the Agencies and 
community to review and respond to this most recent and highly relevant 
information.
Conclusion
    In conclusion, Amgen thanks the Committee for the opportunity to 
submit written testimony. We are proud of EPOGEN''s long 
history of safely and effectively treating anemia in ESRD patients. We 
stand alongside the physicians, nurses and other healthcare providers 
in supporting the best possible care for highly vulnerable kidney 
disease patients. Amgen remains concerned that legislation based on an 
insufficient analysis of relevant clinical data could result in 
unintended negative consequences for patients and for U.S. health care.

                                 
                   Statement of Kidney Care Partners
Introduction
    Chairman Stark, Representative Camp, and distinguished members of 
the Subcommittee, the undersigned members of Kidney Care Partners (KCP) 
thank you for the opportunity to provide written testimony regarding 
anemia management and the continuing effort to ensure safe and 
appropriate care for patients with End Stage Renal Disease (ESRD). KCP 
is a nationwide alliance of representatives from the entire kidney care 
community, including patients and their advocates, nephrologists, 
nurses, dialysis care providers, and manufacturers who have joined 
together to improve the quality of care and quality of life for 
individuals suffering from kidney disease and kidney failure.
    KCP recognizes the serious and important questions that have been 
raised by recent analyses in the area of anemia management. KCP 
applauds the efforts of those who have demonstrated concern for the 
safety of different patient populations within the ESRD program and 
remains committed to the need for careful consideration of drug 
utilization patterns as new research is released. Advancements within 
the kidney care community during the last ten years have been well 
documented, and KCP desires to build on this history by volunteering 
the collective knowledge, experience, and perspective of its members as 
Congress reviews issues related to anemia management and endeavors to 
improve the ESRD program.
Commitment to Safe and Appropriate Anemia Management
    The kidney care community believes strongly that there should be 
one motivation for determining utilization of drugs used to treat 
anemia, and that motivation is patient well-being. The National Kidney 
Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) 
Guidelines and the Clinical Performance Measures (CPMs) developed by 
CMS and the ESRD Networks provide critical guidance for physicians to 
use as they work to keep patients feeling well, while also meeting 
important medical standards. KCP also believes there should be one goal 
for anemia management policy, and that goal is ensuring safe and high 
quality care. To those ends, KCP puts forth the following guideposts as 
essential to a proper consideration of anemia management and related 
policy.
    First, drugs used to treat anemia have a history of enhancing 
patient care by improving clinical conditions and quality of life while 
reducing the risks from transfusions. In particular, KCP would like to 
point out with pride the continuous improvement in the mortality rate 
of ESRD patients for the past 10 years that has been repeatedly 
highlighted in the USRDS data. KCP believes any well-balanced 
consideration of anemia management and related policy should be 
attentive to this reality and this record.
    Given the kidney failure patients on dialysis have experienced, 
treatment with erythropoietin stimulating agents (ESAs) ensures that 
dialysis patients have the hemoglobin levels necessary to sustain their 
energy levels and physical functioning, thereby improving patients' 
ability to engage in typical daily activities, including a parents' 
capacity to raise their children and an employees' potential to head to 
work.
    Moving from the patient to the aggregate level, ESAs have been part 
and parcel of the kidney community's ability to advance the quality of 
care during the past ten years. As the Centers for Medicare and 
Medicaid Services (CMS) stated, ``Since 1994, [CMS] has documented 
continued improvements, specifically in the adequacy of dialysis and 
anemia management. The providers of dialysis services are to be 
commended for their ongoing efforts to improving patient care.'' \1\ 
CMS' findings reflect the fact that most ESRD patients meet the CPM 
benchmarks developed by the Agency in consultation with independent 
experts. Ensuring that patients meet the core standard of the CPMs 
(i.e. hemoglobin levels > 11g/dL) means that there are fewer 
hospitalizations and lower expenses for the Medicare program.
---------------------------------------------------------------------------
    \1\ Centers for Medicare and Medicaid Services, 2005 ANNUAL REPORT 
ESRD CLINICAL PERFORMANCE MEASURES PROJECT 35&38 (2005).
---------------------------------------------------------------------------
    More directly, ESAs have reduced the rate of transfusion in the 
dialysis population, which has helped reduce the risk from transfusion, 
lower the impact on antibodies in transplant candidates, and mitigate 
the chance of infection and iron overload. These benefits, as well as 
ESAs' ability to improve patient quality of life, should be considered 
in striking a safe and appropriate balance for individual ESA use.
    Second, the entire kidney care community is committed to the 
highest standards and the most current science on anemia management. 
The community, however, is also acutely aware of the need for anemia 
management policy to be sensitive with respect to patients' varied 
physiologic responses to ESAs and responsible with regard to the 
unanswered questions that overlay current anemia management research.
    Because each patient receiving dialysis responds differently to the 
drugs used to treat anemia, it is not possible to determine a single 
dosing regime that works for all patients at all times. This means that 
physicians must establish unique dosing regimes for each patient for 
whom they provide care. Ultimately, a system impeding this flexibility 
is a system impeding its own goals of safe and appropriate care.
    This point underscores the need for responsible action when 
reacting to current research on drug utilization in anemia management. 
There can be no doubt that current research raises many significant 
questions, but not all of the questions raised may be fully applicable 
to ESRD patients. The study results of CHOIR and CREATE, as reported in 
the New England Journal of Medicine (NEJM), for example, focused on 
patients with kidney disease, but not those in full kidney failure 
(ESRD). As CMS has noted, ``Anemia management for patients with ESRD 
cannot be assumed to be the same for patients, often younger, with 
chronic kidney disease who do not require dialysis--Patients receiving 
dialysis are exposed to clinical situation that patients with [Chronic 
Kidney Disease] CKD not requiring dialysis are not exposed to, 
including artificial kidney membrane exposure, large fluid shifts 
during dialysis--'' and other situations.\2\ In addition, the NEJM 
studies looked at patients intentionally maintained at hemoglobin 
levels outside the target range of 11-12 g/dL.
---------------------------------------------------------------------------
    \2\ Statement of Leslie V. Norwalk, Acting Administrator, Centers 
for Medicare and Medicaid Services, Before the House Committee on Ways 
and Means, December 06, 2006.
---------------------------------------------------------------------------
    Although we believe it is important to review these studies in the 
context of current treatment protocols, policy-makers should not rush 
to judgment and implement broad policy changes based upon only a few 
studies where experts have yet to determine how they relate to patients 
with kidney failure and current practice protocols. Policy-makers must 
have access to the best cumulative data to answer properly the question 
of appropriate anemia management policy, and KCP is committed to 
maintaining a proactive dialogue as new research becomes available.
    As part of this cautious approach, KCP firmly and steadfastly 
rejects any effort to use current research on anemia management as a 
justification to withdraw funding from the ESRD program. The trail of 
concern leading to this hearing has been paved with the logic of 
structural reform, not the need for payment cuts. If one is convinced 
that the incentives are misaligned with respect to drug utilization, 
then it is the incentives that need to be fixed. Resources should not 
be taken away from the ESRD program.
Commitment to Overall Quality in Patient Care
    To the extent that questions about safe and effective care are 
driving the reform agenda, the discussion should not end with 
consideration of drug utilization alone. On the contrary, a genuine 
commitment to appropriate care should be carried through with respect 
to ensuring that the ESRD program as a whole continues to be structured 
so as to provide the highest quality care to patients with irreversible 
kidney failure.
    At the broadest level, policies affecting patients with ESRD must 
be based upon the goal of ensuring continued improvements in the 
quality of care provided, and any changes to the system must reflect 
and advance this goal. More specifically, this means that policies 
impacting care for ESRD patients should ensure there are no incentives 
driving utilization. This requires equal vigilance against the 
possibility that patients will be under-provided essential drugs and 
services, or worse yet, selected against by a structural impetus to 
``cherry pick'' relatively healthier patients with advantageous 
treatment scenarios.
    Put another way, any reform effort should seek to enhance the 
existing high quality of the community and not hinder it. According to 
the most recent data collected by CMS, more than 90 percent of patients 
attain dialysis adequacy, approximately 83 percent have hemoglobin 
levels above 11, 82 percent have albumin levels (an indicator of 
nutrition) greater than 3.5 g/dL, and 54 percent of patients have an AV 
fistula as their access. These data demonstrate the quality has 
improved substantially over the years; yet, there is more that can be 
done. To that regard, KCP strongly supports implementing a continuous 
quality improvement program, as outlined in legislation introduced by 
Representatives John Lewis and Dave Camp.
    Quality in patient care is also a product of the stability and 
sustainability of the treatment system. At present, however, there is a 
piece missing from a stable programmatic foundation. While every other 
prospective payment system within Medicare is provided an annual update 
mechanism tied to inflation, so that the commitment to quality in those 
programs is paired with the resources necessary for its attainment, the 
ESRD program does not include such an assurance. Moreover, ESRD 
providers operate in a competitive marketplace with other health care 
providers that receive annual updates under their payment systems. 
Providers receiving annual updates enjoy a significant advantage in 
their ability to offer compensation designed to attract and retain 
nurses and other professional staff, for example. Over time, the lack 
of an annual update mechanism could impede ESRD providers' ability to 
remain competitive with other health care sectors.
    It is equally critical that any reform effort look beyond the 
clinical aspects of the ESRD program to consider the broader potential 
to make strides by renewing the community's capability to focus on 
education, prevention, technology, and how services are delivered. 
Today's reform agenda may rightly reflect today's concerns, but insofar 
as the ERSD program has not been comprehensively reexamined since its 
creation in 1973, there is strong reason to believe we are not 
adequately considering tomorrow's opportunities. KCP believes that 
reform should not be locked into a responsive mode, but should be 
proactive in achieving innovations and interventions that can save 
lives and conserve resources.
    Beginning with education, the ERSD program should provide 
mechanisms to inform patients about the ways to delay and prepare for 
the onset of irreversible kidney failure. Specific educational 
initiatives include protocols for patients with Stage IV chronic kidney 
disease; other prominent efforts involve the training of patient-care 
dialysis technicians. Prevention efforts are quite similar in concept, 
but operate earlier and more broadly. These seek to halt the 
development of risk factors and instances of early-onset, but also 
extend to initiatives that prevent older patients from developing such 
extensive co-morbidities as to irredeemably ``crash into dialysis.''
    Alongside education and prevention, the ESRD program should 
prioritize and incentivize new technological breakthroughs in 
pharmaceuticals, devices, and delivery mechanisms alike. The creation 
of the ``fistula''--a surgically enlarged vein (usually located in the 
wrist or elbow) that provides access to the bloodstream for 
hemodialysis--offers a prime example of the cost savings and quality 
benefits that flow from innovation. The successful ``Fistula First'' 
initiative, sponsored by CMS, further exemplifies the latent potential 
of collaboration to improve technology--and with it the efficiency and 
quality of patient care.
    Finally, policies to advance flexibility in service delivery are 
also critical given the weakened condition and regular treatments that 
characterize ERSD patients. All dialysis modalities should be 
adequately funded, and studies should proceed as to why some remain 
underutilized. For example, home dialysis and more frequent dialysis 
should be studied so as to improve both patient access and quality of 
clinical outcomes.
Conclusion
    KCP is committed to the goals of safe, appropriate, and high-
quality care for ESRD patients. In turn, KCP operates under the 
conviction that any anemia management reform should be well balanced, 
well grounded, and well considered. This means taking into account the 
advances and achievements in anemia management brought about by ESAs, 
alongside any concern regarding their utilization, as one derives 
motivation and methods for reform. It also means that current research, 
given its preliminary state, should be viewed as an urgent call for 
further inquiry, but not as a springboard for precipitous action. It 
finally leads to the conclusion that reform, when achieved, should be 
responsive to its animating goals of safety and efficacy, and not to a 
desire for payment cuts.
    KCP is also of the mind that a commitment to the goal of safe and 
effective care is not well served when it ends with anemia management 
alone; on the contrary, KCP believes this commitment should extend to 
all those elements of the ESRD program relating to the quality of 
patient care. This means, first and foremost, that any reform should 
strive to ensure continued improvements in the quality of care. More 
specifically, this means ensuring stable and sustainable system 
economics and an update mechanism while ensuring there are no non-
clinical incentives for utilization. It also means endeavoring to 
proactively reform the ESRD program, to strengthen our commitment to 
education, prevention, technology, and flexibility in order to improve 
not only the care we deliver to those patients served by the ESRD 
program, but also the quality of life for those individuals who can 
avoid kidney failure.
    In closing, KCP wishes to recognize and thank Representatives Camp 
and Lewis for their leadership in advancing the Kidney Care Quality and 
Education Act and to also recognize the commitments over the years by 
Chairman Stark and Representative McDermott to improve care for all 
kidney patients. We are committed to working with Congress to 
strengthen the Medicare ESRD program and welcome the opportunity to 
serve as a resource to the Committee in that regard.
    Abbott Laboratories
    Advanced Magnetics, Inc.
    American Kidney Fund
    American Nephrology Nurses' Association
    American Regent, Inc.
    American Renal Associates, Inc.
    American Society of Nephrology
    American Society of Pediatric Nephrology
    California Dialysis Council
    Centers for Dialysis Care
    DaVita, Inc.
    DaVita Patient Citizens
    Diversified Specialty Institutes
    Fresenius Medical Care North America
    Genzyme
    Kidney Care Council
    National Kidney Foundation
    National Renal Administrators Association
    National Renal Alliance, LLC
    Northwest Kidney Centers
    Renal Advantage, Inc.
    Renal Physicians Association
    Renal Support Network
    Renal Ventures Management, LLC
    Satellite Health Care
    U.S. Renal Care
    Watson Pharma, Inc.

                                 
         Statement of National Renal Administrators Association
    On behalf of the National Renal Administrators Association (NRAA), 
I am pleased to submit the following statement for the record of the 
Subcommittee hearing on safety concerns regarding the dosing of 
erythropoiesis stimulating agents (ESAs), variation in utilization of 
ESAs across providers, and reimbursement issues. We commend the 
Committee for its interest in the health and safety of dialysis 
patients and the current system for reimbursing providers.
    The NRAA is a voluntary organization representing professional 
managers of dialysis facilities and centers throughout the United 
States. Our membership includes free-standing and hospital-based 
facilities, which are for-profit and non-profit providers located in 
urban, rural and suburban areas and serving dialysis patients in all 
settings. Many of our members are small providers and treat patients in 
underserved inner city and rural locations. NRAA members are located in 
virtually every congressional district.
    We welcome the opportunity to comment on the appropriate dosing of 
erythropoietin (EPO) and its impact on reimbursement. We see the 
effects of anemia and of adequate management every day. It is a serious 
matter and we applaud the Committee's interest and concern.
    Patients with ESRD suffer from anemia because their kidneys do not 
produce a hormone that regulates red blood cell production. Anemia 
seriously affects every organ system, including the brain, and has a 
direct impact on a patient's quality of life. Anemic ESRD patients have 
more difficulty performing every day activities, including working. 
They experience lower vitality and may suffer from depression.
    A patient's degree of anemia is measured by hemoglobin or 
hematocrit levels. A healthy man, for example, has a hemoglobin level 
of 15 (a hematocrit level of approximately 45 percent), with slightly 
lower values in healthy women. Before effective treatment was available 
an ESRD patient on dialysis would typically have severe anemia: A 
hemoglobin level lower that 10 (hematocrit level lower than 30). This 
could be treated only through blood transfusions.
    There is no definitive consensus within the scientific community 
regarding optimal anemia management, or hemoglobin levels for the ESRD 
population. There is, however, an extensive volume of peer-reviewed 
literature discussing what the optimal target hemoglobin/hematocrit 
level for patients with ESRD should be. The Food and Drug 
Administration (FDA) label recommends a target hemoglobin of 12 grams 
per deciliter.
    As everyone knows, recent studies in the New England Journal of 
Medicine have created renewed controversy and discussion. These studies 
found in kidney disease patients not yet on dialysis an association 
between higher hemoglobin levels and increased risk for adverse effects 
ranging from cardiovascular morbidity and death to episodes of elevated 
blood pressure and headaches.
    We firmly believe, as does everyone involved in the care of 
patients with kidney disease, that anemia management in ESRD patients 
should be medically appropriate and designed to maximize benefits and 
minimize risks. We also believe that all care-givers should comply with 
the FDA labeling requirements. We urge the Committee to recognize, 
however, that determining and maintaining optimal hemoglobin levels is 
not straightforward, but is complex and inextricably linked to patient 
variability. Health care providers and policy makers are accustomed to 
the fact that providers treat patients with conditions across a wide 
range of acuity: some patients are more severely ill and some have more 
co-morbidities than others. It is also important to note that it is 
very common for the same ESRD patient to experience variations in 
hemoglobin level, resulting from co-morbidities, hospitalizations and 
unique physiology. Because of the variability, optimal anemia 
management requires a highly flexible and individualized approach to 
treatment.
    The recent CMS EPO Monitoring Policy recognizes the need for the 
reimbursement policy to take into account patient variability. When 
reviewing this policy, it is important to note that it is not a 
treatment guideline. Rather, it is a reimbursement auditing tool. Under 
the policy, if a patient's hemoglobin reaches 13 and the dose is not 
reduced, CMS will reduce the payment 25 percent. It does not call for, 
nor recommend, that patients' hemoglobin levels be maintained above 12.
    Because of the scientific and clinical complexity surrounding 
anemia management in ESRD patients, the NRAA believes that Congress and 
CMS should take all available studies, as well as the FDA label, into 
account when setting Medicare payment policy. Further, we urge great 
caution in making policy decisions based on recent studies, which focus 
on patients undergoing chemotherapy not dialysis, or with chronic 
kidney disease and not yet in need of dialysis treatments. More 
research is needed, focusing exclusively on patients with ESRD. Until 
there is indisputable scientific evidence that the current parameters 
of anemia management in ESRD patients are inappropriate, it would be 
premature for the Congress or CMS to revise Medicare reimbursement 
policy based on these considerations.
    We also wish to point out the recent recommendations of a work 
group of the National Kidney Foundation.
    ``The Hb target is the intended aim of ESA therapy for the 
individual CKD patient. In clinical practice, achieved Hb results vary 
considerably from the Hb target.
    2.1.1 In the opinion of the work group, selection of the Hb target 
and selection of the Hb level at which ESA therapy is initiated in the 
individual patient should include consideration of potential benefits 
(including improvement in quality of life and avoidance of transfusion) 
and potential harms (including the risk of life-threatening adverse 
events.) (Clinical Practice RECOMMENDATION)
    2.1.2 In the opinion of the work group, in dialysis and non-
dialysis CKD patients receiving ESA therapy, the selected Hb target 
should generally be in the range of 11.0 to 12.0g/dL. (Clinical 
Practice RECOMMENDATION).
    2.1.3 In dialysis and non-dialysis CKD patients receiving ESA 
therapy, the Hb target should not be above 13g/dL. (Clinical Practice 
Guideline--MODERATELY STRONG EVIDENCE)''
    CMS reimbursement policies, including the monitoring policy to 
ensure reimbursement for anemia management is medically appropriate and 
in adherence to FDA label specifications, should be consistent with 
current medical standards of care and should not create incentives to 
over-or-under prescribe, and should allow doctors the flexibility to 
manage anemia on a per-patient basis. Medical decisions should be made 
on the basis of the best patient care and should not be driven by 
reimbursement considerations.
    We also want to comment on one specific aspect of the current 
reimbursement system. We are aware of and fully appreciate the costs of 
the current program to Medicare. There were an estimated 290,000 
patients on dialysis who are covered by Medicare, according to a 2004 
report of the U. S. Renal Data System (USRDS). We also know that the 
increase in the rates of diabetes and hypertension, particularly in the 
minority community, will, unfortunately, lead to a continued growth in 
the number of patients needing dialysis. While we are concerned with 
increasing Medicare expenditures and the need to stabilize the program, 
we do not believe that taking action to reduce reimbursement rates for 
dialysis providers or failing to address the current inequities in the 
program is the answer.
    Inadequate reimbursement is a particularly acute problem for the 
smaller provider (SDO) that has to absorb increases in pharmaceutical 
costs and medical products, employee compensation and benefits, 
utilities and other requirements simply to continue to serve their 
patients. Smaller providers do not have the ability to cost shift to 
commercial carriers to offset inadequate Medicare reimbursement. For 
most SDOs, Medicare and Medicaid account for nearly 80 percent of their 
revenue.
    Nor do the SDOs have the purchasing power to gain the discounts 
that are available to the large dialysis organizations (LDOs). 
Currently, the majority of independent dialysis providers purchase 
through one of two specialty Group Purchasing Organizations (GPOs). The 
largest of these purchases for more than 80 percent of the independents 
but still cannot achieve the discounts afforded to the LDOs. 
Additionally, the small providers do not have the ability to share 
profits or losses among a number of facilities.
    Unfortunately, because of the lack of adequate Medicare payments, 
some providers are being forced to close their doors, requiring 
patients to seek care in other facilities, which in rural areas can 
require hours of driving time. Given the fact that most patients must 
receive treatment for the better part of the day--three times or more a 
week--the additional driving time is a tremendous hardship. It is a 
very sad commentary that, in some instances, patients have decided to 
stop treatment rather than place the burden of travel on their loved 
ones.
    Let me take a few minutes to review the history of the Medicare 
ESRD program. In 1972, Congress expanded Medicare coverage to include 
all patients suffering from kidney failure, no matter what their age. 
Dialysis was a new, life safe-saving procedure. In 1983, because of the 
unexpected costs of the program, Congress created the composite rate 
for dialysis services, which was Medicare's initial prospective payment 
system. In response to a proposed reduction in the composite rate by 
the Centers for Medicare and Medicaid Services (CMS), then the Health 
Care Financing Administration (HCFA), Congress intervened and limited 
the reduction. But there was no statutory provision for updating the 
reimbursement rate. As a result, for over two decades, the composite 
rate payment system has not kept pace with costs, leaving many 
providers inadequately paid for their dialysis services.
    From 1983 until congressional intervention in 1986 to stop a 
significant reduction in the composite rate payment, the Centers for 
Medicare and Medicaid Services (CMS) continually expanded the bundle 
through the ``folding in'' of previously separately billable items such 
as common volume expanders and laboratory services. The composite rate 
payment recognized none of these ``folded in'' services. In fact, the 
payment for freestanding dialysis providers decreased from $138 to $123 
per treatment. Additionally, despite annual recommendations by first 
the Prospective Payment Assessment Commission and then the Medicare 
Payment Advisory Commission (MedPAC) for an increase in the composite 
rate, neither Congress nor the Administration supported increases 
except on two occasions.
    In a 2003 report to Congress entitled ``Toward a Bundled Outpatient 
Medicare End-Stage Renal Disease Prospective Payment System,'' CMS 
acknowledged that the current system has not addressed the increases in 
costs and the losses that providers have incurred in treating Medicare 
patients.
    The following table is a summary of the increases in the Consumer 
Price Index (CPI), the Medical Care Component of the CPI from 1996 to 
2006 and the corresponding increases in Medicare reimbursement for 
hospital and for dialysis providers.
----------------------------------------------------------------------------------------------------------------
                                    Consumer Price       Medical Care                           ESRD Composite
              Year                     Index CPI           Component        Hospital Update          Rate
----------------------------------------------------------------------------------------------------------------
1996                                           3.0%                3.0%                1.5%                0.0%
----------------------------------------------------------------------------------------------------------------
1997                                           2.3%                2.8%                2.0%                0.0%
----------------------------------------------------------------------------------------------------------------
1998                                           1.6%                3.4%                0.0%                0.0%
----------------------------------------------------------------------------------------------------------------
1999                                           2.2%                3.7%                0.5%                0.0%
----------------------------------------------------------------------------------------------------------------
2000                                           3.4%                4.3%                1.1%                1.2%
----------------------------------------------------------------------------------------------------------------
2001                                           2.8%                4.7%                3.4%                2.4%
----------------------------------------------------------------------------------------------------------------
2002                                           1.6%                4.7%                2.8%                0.0%
----------------------------------------------------------------------------------------------------------------
2003                                           2.3%                4.1%                3.4%                0.0%
----------------------------------------------------------------------------------------------------------------
2004                                           2.7%                4.5%                3.3%                0.0%
----------------------------------------------------------------------------------------------------------------
2005                                           3.4%                4.3%                3.7%                1.6%
----------------------------------------------------------------------------------------------------------------
2006                                           2.5%                4.5%                3.4%                1.6%
----------------------------------------------------------------------------------------------------------------
Average                                        2.5%                4.0%               2.28%               0.61%
----------------------------------------------------------------------------------------------------------------
Cumulative Total                              27.8%               44.0%               27.3%                6.8%
----------------------------------------------------------------------------------------------------------------
Sources                                 Bureaus of Labor    Bureaus of Labor       Medicare   ..................
                                  Statistics--Depart  Statistics--Depart
                                           ment of Labor       ment of Labor
----------------------------------------------------------------------------------------------------------------

    As you can see, the table shows that hospitals have received total 
increase of 27.3 percent, reflecting the overall increase in the CPI, 
versus 6.8 percent for dialysis providers. This lack of adequate 
reimbursement for dialysis providers has established a perverse 
arrangement in which providers, to survive, continuously have had to 
squeeze productivity and margins. Furthermore, as we noted earlier, 
since commercial coverage represents such a small portion of income for 
dialysis providers, the Medicare losses cannot be shifted to private 
insurers.
    On January 9, 2007, MedPAC convened a session on the ``Adequacy of 
Outpatient Dialysis Payments.'' Staff reviewed the Medicare margins for 
the two largest dialysis providers and all other providers. The data 
showed that the two largest providers have a 10.7 percent margin and 
the other providers only a 2.6 percent margin. SDOs clearly have unique 
financial concerns and many have been forced to sell or shut down, 
which is one of the reasons that the two largest chains now serve more 
than 70 percent of the dialysis patients.
    Any changes in reimbursement policy should address the need to 
create a statutory mechanism for an annual update. It is only fair that 
dialysis providers be granted the same statutory right to an annual 
update as all others who participate in Medicare. We firmly believe 
that the Medicare reimbursement system must be based on two fundamental 
principles: providing the highest quality of care to our patients and 
guaranteeing a sound financial footing for our members.
    We thank you for the opportunity to present our views and look 
forward to continuing to work together to ensure that whatever action 
is taken is fair to patients, providers and the Medicare program.

                                 
                   Statement of Renal Support Network
    The Renal Support Network strives to help patients with chronic 
kidney disease (CKD) improve their employability and develop their 
personal coping skills and special talents by educating and empowering 
them, as well as their family members, to take control of the course 
and management of the disease. We who have CKD are very grateful for 
the ESRD program and how it has helped both prolong our lives and 
improve the quality of our lives. I am writing to provide the patient's 
perspective on two aspects of care for patients with CKD that are 
currently being considered by your Committee--namely, appropriate 
anemia management and the bundling of dialysis services.
    Patients with kidney disease often have anemia because their 
kidneys do not produce enough of the hormone erythropoietin. This 
hormone stimulates red blood cell production. Anemia is common in 
patients with CKD and is almost universal in patients with stage 5 CKD 
who are on dialysis.
    The introduction of Erythropoiesis Stimulating Agents (ESA) to 
treat anemia in patients with renal disease has dramatically improved 
patient quality of life. In addition, patients no longer have to be 
transfused on a regular basis. Before ESAs were available, we commonly 
received red blood cell transfusions, which carried the risks of 
infection, iron overload, and potentially reducing the chances of 
receiving a kidney transplant.
    Please keep in mind the following when making decisions:

      All drugs carry risks. Patient safety, coupled with 
respect for patient quality of life concerns, should always be 
paramount in drug prescribing and dosing. A dialogue between the 
patient and physician is critical to determine what is best for each 
individual patient.
      Patients with CKD, especially those on dialysis, are 
exposed to conditions that make their anemia significantly different 
than patients with cancer (e.g., ongoing need for ESA therapy versus 
temporary need for those with cancer, ongoing blood loss from the 
dialysis procedure, etc.).
      ESAs remain the best treatment for anemiain patients with 
CKD.
      Given the major loss of blood inherent with dialysis, ESA 
treatment sustains the hemoglobin level and allows patients to have 
higher levels of energy.
      Based on the newest safety data, RSN agrees with the 
latest recommendation from the National Kidney Foundation's Kidney 
Dialysis Outcomes Quality Initiatives (KDQOITM) panel of 
experts that calls for targeting patients' hemoglobin levels (the blood 
test used to measure anemia) between 11 and 12 g/dL. In making this 
recommendation, the KDOQITM states that actual Hb levels may 
fluctuate to above or below this target range because of natural 
variations in Hb.
      In its most recent report, CMS found that 83 percent of 
all patients with ESRD had a mean hemoglobin 11 g/dL and that the mean 
hemoglobin for patients was within the 11-12 g/dL range.
      Patients want to make sure that the progress in anemia 
outcomes that has been made over the past two decades is not reversed.
      Patients want to make sure that the therapies they 
receive are being administered safely, but also do not want to 
sacrifice the quality of life benefits associated with an appropriate 
hemoglobin, or run the risk of an increase in blood transfusions if Hb 
levels are kept inappropriately low.

    I, among fellow patients in our organization, have witnessed 
firsthand the evolution of anemia management in patients with kidney 
disease. With the introduction of ESAs, thousands of patients have been 
spared the risks associated with multiple blood transfusions. The 
quality of our life and level of functioning has improved markedly. 
This has been shown in many clinical studies and evidenced by the 
patients themselves. I would specifically like you to give high 
priority to considering the issue of quality of life as it pertains to 
the guidelines that will be used to manage anemia in patients with CKD.
    Although some say that quality of life should not be considered 
when administering care, RSN supports the position stated in the 2007 
Medicare handbook that the Medicare program is helping patients to 
``stay healthy and active.'' The importance of quality of life is also 
eloquently stated in the mission statement of the National Center for 
Chronic Disease Prevention and Health Promotion which states that they 
strive to ``promote health and quality of life by preventing and 
controlling disease, injury, and disability.''
    Anemia is one of the most devastating and potentially debilitating 
conditions that affect those with CKD, and it can dramatically affect 
our quality of life. Many people who have CKD can relate experiences of 
how anemia has affected them personally (please visit our website to 
hear their personal stories). Symptoms include chest pain, feeling 
cold, feeling tired, low energy levels doing routine activities of 
daily living, poor appetite, shortness of breath, depression, a poor 
sense of well-being, and an inability to work, manage a home, or 
volunteer--in short, loss of a meaningful quality of life. Patients 
visit doctors out of what they sense about some symptom that is 
affecting our quality of life (i.e. ``how we feel''). We simply have no 
other way to communicate. While preservation of life is certainly a 
primary focus of medical care, an equally important goal is to help us 
preserve or regain our quality of life. An illness is too demanding 
when you don't have hope!
    There is much to be learned about anemia management in the CKD 
patient population, and more analyses and studies need to be conducted. 
We hope that quality of life will not be ignored in the current 
dialogue and decision-making--to do so is tantamount to ignoring the 
patient.
    A second issue that is currently under discussion by your Committee 
is potentially changing the dialysis payment process in favor of a 
bundling approach. We are concerned that sudden revisions in the 
reimbursement policy may unintentionally lead to a decrease in our 
quality of care or quality of life. We would like to bring up a few 
points to consider to ensure that the new policy remains focused on the 
patient:
    1. Ensure that the new policy does not result in the disappearance 
of patient care services that dialysis facilities currently provide.
    2. Laboratory testing must be done in the dialysis setting to 
ensure patients receive optimal care. This is crucial for dialysis 
patients to remain viable candidates on the transplant list. In 
addition, for every extra stick a kidney patient receives to draw blood 
is counterproductive to CMS's Fistula First and National Vascular 
Access Initiative. We need to preserve our veins.
    3. Ensure that all people who have ESRD have access to quality 
care, as jointly defined by medical professionals and patients.
    4. Ensure that any newly implemented policies include provisions 
for ongoing and timely modifications in the definitions of quality of 
care and quality of life based on current data and the newest 
therapies.
    5. Ensure that all patients continue to receive education on the 
differences between modality options (including home dialysis and 
kidney transplantation).
    6. Include provisions that will continue to allow patients real 
choices on where they dialyze and have the ability to travel throughout 
the United States.
    7. Include provisions and a financial model that will allow both 
small and large providers to remain viable, thereby providing patients 
with true choices on where to dialyze.
    8. Provide reimbursement structures that will continue to allow and 
motivate dialysis facilities to employ the best professional staff, 
upgrade dialysis machines, and integrate new equipment based on 
technological innovations.
    9. Provide a reimbursement structure that will continue to motivate 
researchers to develop innovative therapies that will improve our 
quality of care and overall well-being.
    10. Develop safeguards to prevent companies from ``cherry picking'' 
patients to avoid treating those who require the most expensive care.
    11. Ensure that safeguards are in place to allow medical 
professionals to provide care based on individual patient needs, while 
protecting patients from needlessly being sent to the hospital or for 
additional physician office visits for care that can be provided in the 
dialysis facility.
    We salute CMS and Congress for their past and ongoing efforts to 
improve the quality of care and quality of life for patients with CKD. 
Prominent examples of how CMS continues to protect the interests of 
patients include Fistula First, National Vascular Access Improvement 
Initiative the Dialysis Facility Compare Website, Know Your Numbers, 
and the Clinical Performance Measures. These efforts are currently 
benefiting hundreds of thousands of individuals, and may positively 
affect millions in the future. We urge CMS and Congress to continue and 
expand these efforts.
    We respectfully request Congress to resist making a premature 
reimbursement decision that may not include complete or accurate 
information on the impact of such a change on patient outcomes. 
Demonstration projects are currently underway or being planned that 
will test whether proposed changes in reimbursement will preserve the 
quality of care for patients with kidney disease. As stated in the 
Medicare handbook, these demonstration projects are designed to reduce 
health risks, improve quality of life, and provide savings. It is 
critical to have an understanding of all the complexities that may 
impact how care is provided under a bundled model before such a model 
is implemented. In addition, when any new system is implemented, it is 
vital that there are regular reviews that allow for evaluation and 
prompt correction of the new payment system if problems arise.
    The reality is that the ESRD program has a flawed reimbursement 
system and the incentives are wrong. Renal Support Network recognizes 
the need for the system to be changed. We urge Congress to take the 
necessary steps to ensure that any change does not unintentionally lead 
to an increase in mortality, decrease in our quality of life, or 
decrease in access to care.
    Thank you for taking the patients' concerns into consideration. 
Please feel free to call if you have any additional questions.
            Sincerely,
                                                      Lori Hartwell
                                          RSN President and Founder

                                 

Research Utilization Project Proposal
Quality of Life Outcomes Related to Anemia Management of Patients with 
        Chronic Kidney Disease
Nancy Newbold and Evelyn N. Reyes
University of Phoenix
Research Utilization Project
NUR/598
Margaret L. Colucciello, PhD, RN
Table of Content
Abstract...............................................................5
Research Utilization Proposal..........................................7
1. Problem Statement: Inadequate Anemia Management Strategies..........7
2. Proposed Solution for Anemia Management Strategy....................8
Section A: Problem Identification:.....................................9
1. Problem identification/Description..................................9
2. Importance of the Problem..........................................10
3. Developing Project Objectives......................................11
4. Brief Proposed Solution Description and Rationale..................11
Section B: Innovation Description:....................................12
1. Solution Description...............................................12
2. Consistency of Solution with Research Support......................12
3. Feasibility of The Solution........................................13
4. Consistency of Solution with Resources.............................13
Section C: Research Support:..........................................14
1. Sufficient Research Support Base...................................14
2. Compelling Research Support Base...................................15
3. Types of Research Articles.........................................15
a. Quantitative.......................................................15
b. Qualitative........................................................16
4. Discussion of Research Studies.....................................16
a. Scientific merit...................................................16
b. Strengths and limitations..........................................17
c. Relevance and rationale for inclusion..............................18
Section D: Implementation Plan........................................18
1. Solution Implementation Plan.......................................18
a. Involvement of formal and informal leaders.........................18
b. Timing of implementation...........................................19
c. Inclusion of personnel.............................................19
d. Obtaining approvals................................................19
e. Communication Methodologies........................................19
2. Resources Needed for Solution Implementation.......................20
a. Timing of implementation...........................................20
b. Involvement of key personnel.......................................21
c. Equipment and materials............................................21
d. Consideration of Costs.............................................21
3. Monitoring Solution Implementation.................................22
4. Utilization of Planned Change Theory...............................22
5. Feasibility of Implementation of Solution..........................23
Section E: Evaluation Plan............................................24
1. Developing or Revising Outcome Measure.............................24
a. A copy of the measure needs to be included in the Appendix......... .
2. Determining Outcome Measure Value..................................24
a. Validity...........................................................25
b. Reliability........................................................25
c. Sensitivity to change..............................................26
d. Appropriateness for use............................................26
3. Data Collection and Analysis.......................................27
4. Resources Needed...................................................27
5. Feasibility of the Plan............................................28
Section F: Decision-Making Strategies.................................29
1. Maintenance of the Solution........................................29
2. Extending the Solution.............................................29
3. Revising the Solution..............................................29
4. Discontinuing the Solution.........................................30
5. Plans for Work Setting and Professional Feedback...................30
References............................................................30
SF-36 Appendix A......................................................33
The SF-36v2TM Health Survey Appendix B.....................36
Quality of Life Outcomes Related to Anemia Management
of Patients with Chronic Renal Failure. Appendix C....................40
CNS AMP Projected Budget. Appendix D..................................48
Abstract
    The main reason for writing this proposal was to bring attention to 
the need of having an Advanced Practice Nurse take on the role of a 
Clinical Nurse Specialist (CNS). Working in dialysis as a Clinical 
Manager, and managing an anemia management program has brought 
effective results in anemia management patients. A patient in dialysis 
by the name of Mack is an 80 something women that comes to dialysis 
three times a week. Mack wears bright clothes with stripes or poke-a-
dots and a beach hat. When she wheels through the doors of the clinic 
she smiles at everyone she meets and if asked how she is, she will go 
into detail about her day. Real or unreal her stories are sweet and all 
the while she is talking there is a big smiling on her face. She is a 
tiny women the size of a child, small and fragile. A short six months 
ago Mack's hemoglobin was critical low and now she has stable 
hemoglobin levels. Her hip fracture is healed and she is not in 
traction anymore. She can pivot to the chair to sit down for her 
treatments. Anemia management helped Mack improve her active daily 
living. Her improvements did not go unnoticed by her daughter, or the 
Nephrologists and mostly her Clinical Manager who was the CNS of the 
AMP at Mack's clinic. Mack, like so many patients in dialysis needs a 
CNS who cares about their future. A future that is unsure, but still 
lives in every one of the patients receiving dialysis. The needs of 
end-stage renal disease (ESRD) patients are many due to the existing 
co-morbidity of life threatening diseases that compound these patients' 
health problems. This proposal recommends that a Master's level nurse 
be hired for a position as Clinical Nurse Specialist (CNS). The 
proposal requests that the Clinical Manager of the dialysis unit take 
on the role of the CNS. By giving the responsibility to the Clinical 
Manager the organization can save resources and still provide a high 
quality performer to manage an anemia program. The rationale for this 
Research Utilization Proposal is found in Hamilton and Hawley's, 2005 
quantitative research. (Appendix C). (Hamilton, R., & Hawley, S., 
2006).
Research Utilization Proposal; Quality of Life Outcomes Related to 
        Anemia Management of Patients with Chronic Renal Failure
1. Problem Statement: Inadequate Anemia Management Strategies
    The National Anemia Action Council and Healthy People 2010 have 
identified anemia as a significant public health concern. At least 3.4 
million Americans have been diagnosed with anemia, and millions more 
may be undiagnosed or at increased risk of developing anemia. Anemia is 
associated with lower functional ability, self-care deficits, and 
depression. Even though the body tries to compensate for the effects of 
anemia, almost every organ system is eventually affected. Even mild 
anemia adversely affects the patient's quality of life (Lipschitz, 
2003). Blood loss, decreased red blood cell lifespan, uremia byproducts 
that inhibit erythropoiesis, decreased levels of erythropoietin, and 
deficiencies in essential nutrients such as foliate acid or iron all 
contribute to the anemic state in CKD patients (Eschbach & Adamson, 
1985; Kulzer et al 1994). Severe anemia (hematocrit (hct) less than 
28%) has been shown to be present in about 50% of patients at the start 
of dialysis, but only 20% had received recombinant human erythropoietin 
(EPO) treatment (Obrador, Ruthazer, Port, Held, & Pereira, 1997). 
Patients treated in the Anemia Management Program (AMP) have anemia 
related to chronic kidney disease (CKD). ``As kidney function declines, 
the likelihood of anemia associated with erythropoietin deficiency 
increases because the deceased kidneys are unable to produce sufficient 
quantities of erythropoiesis. Frequently, anemia manifests early in the 
spectrum of CKD and worsen over time'' (Lipschitz, D. (2003) p, 140). 
Effective treatment of the anemia in CKD improves survival, decreases 
morbidity, and increases quality of life (Sowers, McClellan, & 
Schoolwerth, 2005). Quality of life can be difficult to define because 
it means different things to different people. For the purpose of this 
Nursing Research Utilization Proposal the emphasis will be on health-
related quality of life because it impacts every aspect of a person's 
life (National Kidney Foundation, Inc). This finding highlights the 
need for more proactive treatment of this condition in the more 
advanced stages of CKD.
2. Proposed Solution for Anemia Management Strategy
    The selection of a clinical nurse specialist (CNS) in a nephrology 
office and dialysis clinic is essential in early detection of the 
anemia condition for the patient population pre-End Stage Renal 
Disease, (ESRD which would coordinate Erythropoiesis Stimulating Agent 
ESA therapy changes based on algorithms supportive of recommendations 
by National Kidney Foundation (NKF), Kidney Disease Outcome Quality 
Indicators, (KDOQI). NKF/KDOQI came out in 2006 with guidelines for the 
clinical nurse specialist (CNS) as the anemia manager monitoring 
hemoglobin levels using an AMP to treat CKD. ESA's therapies are found 
to improved quality of life for the ESRD patient by improving the 
patient's ability to maintain independent for Activities of Daily 
Living (ADL's). (NKF, 2006, para 2). According to the NKF KDOQI 
guidelines the CNS will work with an interdisciplinary team which is 
aliened with the mission statement of the Kidney Disease Indicators and 
Global Outcomes (KDIGO) which states ``Interdisciplinary approach: Work 
Group members will be chosen for leadership in their respective fields, 
commitment to quality of care and expertise in clinical practice, with 
due consideration of international representation reflecting the 
mission statement of KDIGO.'' (NKF, KDIGO, 2006, par 2). The CNS who 
manages the AMP identifies earlier referrals by primary care providers 
as the intervention with the greatest potential to impact positively 
the quality of life for patients with anemia. Research supports the 
CNS's outcome objectives of stable Hgb. Levels at 11 to 12 and uses 
ESA's to accomplish this. The symptoms of chronic renal failure appear 
late in the course of the disease, and earlier referrals to a 
nephrologists by the CNS can lead to a better quality of life for 
patients with renal disease (Frimat et al 2004). The CNS has an 
opportunity to make a positive impact on patient outcomes by educating 
other members of the healthcare team, such as physicians, case 
managers, and diabetes educators, regarding the advantages of 
identifying and screening high-risk patients. Earlier screening can 
lead to earlier referral. With the continued increase in CKD and the 
anemia that accompanies it, organizations may find the CNS's to be a 
valuable resource for managing this patient population. A CNS is well 
prepared and qualified to manage patients with chronic health problems, 
and the positive impact of a CNS-managed program need not be limited to 
anemia. By controlling anemia the CNS has opened up an increase quality 
of life for the pre ESRD patient as well as the ESRD patient receiving 
dialysis.
Section A: Problem Identification:
1. Problem identification/Description
    The problem of health related symptoms of the ESRD patient can be 
addressed by the Clinical Nurse Specialist (CNS) in treating anemia for 
the end-stage renal disease (ESRD). Patient who are afflicted with ESRD 
are linked to the disease pathology and patient compliance issues 
increasing risk factors for anemia. The CNS has his or her work cut out 
for them. This is due in part to patients not showing up for 
treatments, not follow aseptic techniques for vascular access, ignoring 
diet and fluid restrictions, and not taking medication supplement or 
take prescribed medication as directed are all at risk behaviors for 
increase inflammation and infections leading to a reduction in red 
blood cell (RBC) production anemia. The loss of kidney function impedes 
the production of red blood cells (RBC's) or a low hemoglobin level, 
for the ESRD patient and therefore, must be compensated through 
replacement therapy. In the past replacement was only available through 
blood transfusions. Blood transfusions were problematic in that the 
patient had to rely on supply, type, correct delivery and not having an 
allergic reaction that could be fatal to the blood product.
    This proposed solution to unstable hemoglobin levels for the 
dialysis patient is to stabilize the levels through drug interventions 
using Epogen. Epogen is a Erythropoiesis Stimulating Agents (ESAs) an 
anti-anemia biologics, distributed as Epogen, Procrit , and Aranesp. 
ESA's are man-made versions of erythropoietin, a hormone that is 
produced in the kidney and stimulates the bone marrow to make more red 
blood cells. ESAs are Food and Drug Administration (FDA) approved for 
the treatment of anemia in CKF patients, in patients with cancer whose 
anemia is caused by chemotherapy, in patients with human 
immunodeficiency virus who are using Zidovudine (also known as (AZT) 
and to reduce the number of transfusions in patients scheduled for 
major surgery (except heart surgery)." (CMS, 2007, para 5).
    A CNS can identify those patients at risk and place them on an 
Anemia Management Program. An AMP can consist of patients at risk for 
ESRD, ESRD patients, cancer patients and blood disorders. The NKF/KDOQI 
guidelines have evidence based research that target supplemental 
treatment for the ESRD patient in ESA dosing with subcutaneous or 
intravascular injection that can be an intravascular push through the 
dialysis system and have a direct affect on improvements in Hgb Levels. 
The solution of a CNS in an AMP is appropriate in treating anemia. A 
Clinical Nurse Specialist CNS using the ESA's in an AMP according to 
Hamilton and Hawley's quantitative research has long lasting benefits 
for compliance and quality of life improvements.
2. Importance of the Problem
    Resolving anemia symptoms has improved the lives of ESRD patients 
for the last 10 years. In an effort to improve the treatment of anemia 
for ESRD patient even more is found in evidence based scientific 
research of ESA's as a treatment option. Treating anemia in ESRD 
patients has been improved with the use of ESA by 51% in the last 10 
years according to NKF. (Best Practice, 2006 topic 4 para. 2) The 
appointment of a CNS to head up this project is necessary because they 
are an advance practice nurse with the management skills necessary to 
understand the complex issues related to anemia and the need for 
homeostasis in hemoglobin (Hgb) levels in the ESRD patient. In Hamilton 
and Hawley's study the presence of a CNS in an AMP resulted in a 
significant improvement in physical and mental conditions in patients. 
(Appendix C).
3. Developing Project Objectives
    The developing project has objective based on the NKF/KDOQI that in 
turn developed these guidelines based on Agency for Healthcare Research 
and Quality (AHRQ) research. The NKF has developed guidelines to help 
in anemia manager or CNS support AMP presentations to a healthcare 
organization. The guidelines are evidence based practice from the 
(AHRQ) Evidence-Based Practice Center a well respected and reputable 
source.
4. Brief Proposed Solution Description and Rationale
    Improvements in patients physical and mental levels is the outcome 
objective and the mode to achieve this would be in appointing a CNS to 
the position of an AMP for a patient population of pre ESRD and ESRD 
patients The individual to be hired would hold a Master in Nursing and 
certification in dialysis. The certification will be a Certified 
Nephrology Nurse CNN which is an accredited program highly respected by 
the nephrology community. CNN is dedicated to education and research 
for the dialysis patient's improvement through evidence based research. 
The CNN meets added requirements of advance education and on going 
Continuing Education Units (CEU's) above the minimal requirements of a 
non certified nurse. The CNN will review of monthly/post 
hospitalizations/infections/inflammation results reflecting a drop in 
hemoglobin/hematocrit levels (Appendix C). Further research is needed 
to evaluate the more accurate outcome to support a CNS involvement in 
an AMP for chronic ESRD. The CNS will prescribe/adjust/and stop ESA 
dosing for newly diagnosed ESRD patients and re-evaluating the 
effectiveness of the ESA doses by the changes in hemoglobin levels 
using an algorithm based on NKF/KDOQI guidelines.
Section B: Innovation Description:
1. Solution Description
    The solution description is the implementation of a CNS to head up 
a well organized medical management AMP using a host of treatment 
modalities to reduce the erratic ups and downs in Hgb levels seen in 
ESRD patients.
2. Consistency of Solution with Research Support
    The present system is reactive to patients currently experiencing 
anemic conditions. The new program called the AMP would be a proactive 
intervention for at risk anemic and ESRD anemic patients. In Robbins 
Study regarding the role of the CNS managing the AMP they support the 
concept. According to Robbins, Nephrology nurses often play a key role 
in managing patients with CKD. The advanced practice nurse or clinical 
nurse specialist may fulfill essential roles in identifying chronic 
kidney disease (CKD) patients at risk for developing anemia and 
managing the iron and epogen requirements of these patients (e.g., 
laboratory assessments of iron and hematology indicators, prescription 
for therapies, such as counseling and surgery). (Robbins, Kerhulas, 
Senger, & Fishbane, 1997).
3. Feasibility of the Solution
    Data has shown that overall prognosis is improved by successfully 
managing and correcting anemia of chronic disease whether the symptoms 
are related to Chronic Kidney Disease (CKD), cardiovascular disease, or 
cancer (Lipschitz, D., 2003). In Lipschitz study the patients are 
managed by a CNS direct AMP for anemia and the results are positive. 
Lipschitz discusses the impact of a CNS that has the experience and 
expertise to provide direction for medical and mental support of the 
ESRD patient. These skills by the CNS make the critical difference in 
the AMP implementation process. (Lipschitz, D., 2003)
4. Consistency of Solution with Resources
    Funding for the CNS presence some challenges. The salary 
requirements for a CNS are not cheap, and healthcare organizations are 
reluctant to hiring high paying salaries to specialty nurses without 
good cause. The decision to make a financial commitment will be solely 
based on the healthcare organization buying into the CNS managed AMP. 
Funding decisions motivated by profits can be an incentive for 
healthcare management to hire a CNS. The decrease of hospitalizations 
and reduction in procedures for this patient population can be 
lucrative. In today's re-imbursement reality for healthcare cost under 
Diagnosis-Related Group (DRG's) a set amount is agreed upon by the 
facility and the insurance carrier.
Wikipedia's encyclopedia defines DRG as:

      Diagnosis-Related Group (DRG) is a system to classify 
hospital cases into one of approximately 500 groups, also referred to 
as DRGs, expected to have similar hospital resource use, developed for 
Medicare as part of the prospective payment system. (Healthcare Cost 
and Utilization Project (C-HUP), 2007)
    According to C-HUP if the patient stays the exact amount of days as 
an inpatient the cost is minimal and profit predictable to the 
healthcare organization, staying less than the targeted days results in 
an increase profit margin for the health care organization, and staying 
too long then the hospital losses money. Since the ESRD patient is at 
risk for infections, heart disease, and electrolyte imbalances all 
requiring prolonged hospitalization an organization such as healthcare 
must look at ways to cut those cost. (National Statistic Archive, 
2007). The proposal to hire a CNS is attractive to healthcare 
management because of the promise to minimize fluctuations in health 
related risk for ESRD patients resulting in hospitalizations. A 
reduction in hospitalizations reduces loss of revenue for the 
healthcare industry. According to H-CUP congestive heart failure (CHF) 
is reported to be the 5th top reasons for hospitalization. ESRD 
patients are a high risk for CHF due to fluid overload (National 
Statistic Archive, 2007).
Section C: Research Support:
1. Sufficient Research Support Base
    According to Van Wyck's study anemia management is a highly 
specialized practice and requires advance practice skills to be able to 
run an AMP. The CNS as a successful anemia management will provide care 
to patients with CKD that requires them to target therapies including 
iron. Van Wyck believes that the goal of iron therapy another treatment 
modality for anemia is to achieve and maintain target Hgb levels, to 
avoid storage iron depletion, and prevent iron deficient 
erythropoietin. (Van Wyck, D.B., 2000). Van Wyck supports the hiring of 
a CNS because they would use protocols and algorithms in the AMP they 
are managing. A CNS would also know the NKD/KDOQI Anemia Management 
Guidelines and use them to serve as an enhancement to current clinical 
practice in the AMP. The CNS will studies the outcome results from 
controlled trials and evaluate if the reports are valid using proven 
resources such as NKF/KDOQI respected expert research of anemia 
management treating ESRD. Van Wyck believes that prospective, 
controlled trials are needed to determine the comparative safety of 
periodic and maintenance IV iron protocols and to explore the 
relationship between IV iron administration, body iron status, and risk 
of infection and ischemic heart disease (Van Wyck, D.B., 2000). The 
healthcare management team chosen to hire the CNS will have to use this 
and other research to test the knowledge and skill set of the CNS. The 
CNS will have to support his or her ability to handle this 
responsibility by knowing about these and other research studies.
2. Compelling Research Support Base
    The innovation to assign a Clinical Nurse Specialist (CNP) to 
manage the Anemia Management Program (AMP) will have a measurable 
impact on the quality of life for Chronic Kidney Disease patients. 
Kimmel and Patel believed that an AMP would help improve patient 
outcomes in terms of cardiovascular function, quality of life, and 
morbidity/mortality. They believed that this would lead to better and 
improved patient compliance to dialysis treatment. (Kimmel & Patel, 
2006).
3. Types of Research Articles
a. Quantitative
    Hamilton and Hawley's quantitative study supports the increase 
number of patients who experience improvement in quality of life from 
having an AMP managed by a CNS. (Hamilton & Hawley, 2005). The 
qualitative studies support positive patient outcomes and improved 
patient compliance (Pruett, Johnson & O'Keefe, 2007). Pruett, Johnson 
and O'Keefe discussed the effectiveness of educating the nursing staff 
using a protocol of application and concluded that a well-trained and 
knowledgeable nurse can improve outcome results for the anemic 
patients. The CNS must be able to discern appropriate dosing of ESA's 
and Iron. ``The primary conclusion from the analysis is that the 
seesawing effect of administering IV iron then withholding iron was 
stabilized as a result of the new IV iron protocol (Pruett, Johnson & 
O'Keefe, 2007, p 211).
4. Discussion of Research Studies
    Many studies have been conducted which consider the impact of 
anemia on patients' quality of life. Decline in physical functioning 
because of anemia has an adverse effect on the patient's quality of 
life. Several clinical trials in young patients with renal disease or 
undergoing chemotherapy for various malignancies have reported a strong 
positive correlation between quality of life score and hemoglobin 
concentrations. Available data have shown that overall prognosis is 
improved by successfully managing and correcting anemia in patients 
with chronic disease such as congestive heart failure and end-stage 
renal disease (Lipschitz, 2003). The Lipschitz study supports the 
hiring of a CNS to manage an AMP because of the CNS's ability to focus 
on anemic conditions and treatment them aggressively. By treating 
anemia early the CNS has a better chance of bring the ESRD patient back 
to therapeutic levels in Hgb.
a. Scientific merit
    Repeating, Hamilton and Hawley research study with a larger sample 
may show a greater increase in the mean scores for both the Physical 
and the Mental Component Score in each of the post treatment time 
frames, especially the 12-month survey. A more consistent, orderly 
approach in the administration of the SF-36 (Appendix A) would be 
beneficial in tracking the progress of patients in the Anemia 
Management Program, (AMP) and increasing sample size for future studies 
would give the result better scientific merit. (Hamilton, R., & Hawley, 
S., 2006). Giving Hamilton and Hawley's study more merit by repeating 
the study with a larger sample size would help improve attitudes of the 
healthcare organizations to comply with proven scientific merited 
research studies such as Hamilton and Hawley and motivate the present 
of CNS's in AMP's.
b. Strengths and limitations
    The strength of appointing a CNS to an AMP would be consistency in 
care. The CNS would be observation, treating and gaining data from the 
SF-36 survey for review. This information obtained would go a long way 
in answering questions about the validity of a CNS managed AMP. In 
Hamilton and Hawley's study one limitation was that the research lacked 
a power analysis. A power analysis would have determined the number of 
patients needed to detect if an increase in quality of life was due to 
anemia treatment. In Hamilton and Hawley quantitative research the 
starting number of patients was 78 then after six months was less than 
20. (Hamilton & Hawley, 2005). In this proposal the power analysis 
would take into consideration the amount of participants. A CNS would 
make this task a high priority and the results would become strengths 
for this program. A limitation that this program would have could be 
the nursing shortage. Due to many nurses being overwhelmed with their 
responsibilities already these nurse might not want to help out with an 
anemia management program. In Hamilton and Hawley's research they found 
that the staff nurses played a significant role in depleting the 
participants in their study. Because the nursing staff was suppose to 
make the SF-36 survey available to the patients at timed intervals not 
doing so had a direct impact on the study. A limitation in Hamilton and 
Hawley's research relates to administration of the Medical Outcomes 
Short Form 36 Item Health Survey (SF-36) (Appendix B). There were 
incidents when the staff failed to make the SF-36 available to the 
patients for self-administration at the designated intervals. In Ware 
and Kosinski they also experienced a lack of commitment by the nursing 
staff to distribute surveys. ``There were also surveys that were 
excluded from the research due to missing data.'' (Ware & Kosinski, 
2001).
c. Relevance and rationale for inclusion
Section D: Implementation Plan
    The implementation phase of any clinical studies is critical for 
the success of the proposed program. The purpose of the implementation 
plan is to make systemic summary and necessary resources to start the 
program on clinical nurse specialist (CNS)-managed anemia management 
program (AMP) to elevate patient quality of life.
1. Solution Implementation Plan
    The target populations for this program are ESRD patients with 
anemia. These patients are likely experiencing decline in physical 
functioning because of anemia and have an adverse effect on the 
patient's quality of life. The plan would be to have a CNS management 
the treatments for the ESRD patient and subsequently decrease the risk 
for anemia.
a. Involvement of formal and informal leaders
    The CNS will actively manage the AMP in collaboration with a 
nephrologist who will serve as the program's medical director. The AMP 
is staff with registered nurses and one program assistant. Nursing 
director, the formal leadership of the nursing division will be 
involved in the initial planning of the AMP as well as the medical 
director. Any additions or changes to protocols or algorithms will be 
presented to the management team and physicians for approval.
b. Timing of implementation
    The medical director together with and the head of nursing division 
and the Clinical Manager will schedule a meeting to discuss the program 
and get approval from the vice president of the hospital's patient 
services. Succeeding monthly meetings will be held for follow-up, 
review and re-evaluations of the AMP.
c. Inclusion of personnel
    One vital role of the CNS is the training and coaching of staff 
nurses to become competent in providing care to patients with anemia 
related to CKD. The program protocol will be developed by the CNS in 
collaboration with the nephrologist for the staff to use, and when 
patient's condition fall outside norms then established protocols and 
algorithms will be followed by staff.
d. Obtaining approvals
    Any treatment adjustments will be decided in a collaborative effort 
by the nephrologists and CNS. The recommendations of treatment will be 
initiated by the CNS who will submit the report to the nephrologists 
with recommendations and requiring approval. Any changed to protocols 
and algorithms will be presented to the healthcare management for 
approval.
e. Communication Methodologies
    The methods of communication will be verbal between CNS and staff. 
A monthly meeting will be convened to hear monthly reports on 
hospitalizations, improvements in quality of life (quarterly), quality 
outcome reports outlining compliance to approved protocols and 
algorithms.
2. Resources Needed for Solution Implementation
    Staffing needs will require the hiring of a CNS to head up the AMP 
within the nephrologists office and chronic dialysis clinic. The 
equipment needed will be a desk, phone, computer, printer, fax and 
office supplies. The space will be located either in the physician's 
office or the dialysis clinic. The educational and technical support 
will be supplied by the educational specialist from the dialysis unit 
and computer staff already in place at the dialysis clinic will support 
the needs of the CNS as well. The support staff for this program will 
be supplied by the existing RN staff nurse and the facility to operate 
this program will be integrated into the clinic area's resources or the 
physicians office. The access to telephones and computer will be 
located in the office of the CNS and are a part of the existing system 
found in both locations.
a. Timing of implementation
    The timing for this implementation will start post agreement with 
management at the facility. Once management has approved hiring a CNS 
the full enactment of the program will follow. The priority items that 
the CNS will have to address are the present mental and physical state 
of the pre ESRD and ESRD patients they are managing. The lab results 
for each patient will be reviewed and the results of those labs will 
dictate how the treatment will start based on the algorithms. The 
interview with staff nurses will lend a substantial amount of data that 
the CNS can use to develop a plan for implementing the program and what 
training is needed by the Nurse Educator. The next step would be to 
start training staff members on how the SF-36 survey would be presented 
and completed by the ESRD patients. The implementation of the SF-36 
survey would then be administered to give more data results for the CNS 
to evaluate a starting level to measure change in quality of living for 
the ESRD patients. A review of the data and reports would be presented 
to the physicians and a collaborative planning session would be held. 
This meeting would discuss methods of addressing issues that are 
expected to present during care in the clinic.
b. Involvement of key personnel
    The procurement office will be in charge in the procurement of the 
assessment tool SF-36 forms and the Orion Outcomes Database that will 
store and analyze the data survey. The Information Technology (IT) will 
be responsible for the computer wiring system and training on data 
input. An educator for staff will be the responsibility of the 
Education department from either the physician's office or the dialysis 
clinic. This personnel to provide training for the staff nurse. Human 
resource is in charge in the processing of the hired the CNS. A budget 
of cost for this program is outlined in Appendix D.
c. Equipment and materials
    The equipment and materials needed for this program consist of 
office support, computers, printers, fax machines--or availability, and 
phones. These can be supplied by the existing office of the Clinical 
Manager if the CNS responsibilities become his or her or out of the 
physician's office. Having a Clinical Manager take on this 
responsibility would also alleviate the need for more office space 
which can be difficult to find in clinics and physician's offices.
d. Consideration of Costs
    The primary resources needed for this program is the clinical nurse 
specialist (CNS) who will manage the program. The average annual CNS 
salary is 76,209 this is based on a salary for an Advance Practice 
Nurse. Other interdisciplinary personnel include the procurement 
department, IT, education and human resources.
3. Monitoring Solution Implementation
    The clinical nurse specialist will monitor outcomes. It will be the 
responsibility of the CNS to provide the SF-36 survey to patients via 
staff nurses in the physician's office and in the dialysis clinic. The 
proof is in the pudding for monitoring solutions that are being 
implemented into any organization. The CNS must have a organized 
approach when setting up this program, staff must to educated and 
trained on the procedures they are responsible for and have competency 
in being able to perform those duties. The reactions to patients 
conditions and the treatments used to help them must be monitored by 
the CNS through direct exposure to the patients charts, or via the 
staff nurses.
4. Utilization of Planned Change Theory
    The planned change theory selected for the CNS-managed AMP on 
patient quality of life is the Stetler model of research utilization to 
facilitate evidenced-based practice. As cited in Burns and Grove 
(2005), ``the model has five phases: preparation, validation, 
comparative evaluation/ decision making, translation/ application, and 
evaluation''. The preparation phase involves determining the purpose 
and potential outcomes of making an evidenced-based change in a 
clinical agency. The purpose of this innovation is to evaluate the 
impact of a CNS managed AMP on stable Hgb's and improvements in the 
quality of life for patients with anemia related to CKD. The validation 
phase involves research finding cited by Sowers et al (2005). As kidney 
functions decline, the likelihood of anemia associated with 
erythropoietin deficiency increases therefore, the hiring of a CNS to 
manage the AMP would be prudent for a healthcare organization to 
prevent the complications of anemia and reduce cost associated with 
ESRD such as long hospital stays. The comparative evaluation/ decision 
making phase is a time to view the end product found when a CNS manages 
an AMP. The responsibilities of the CNS is to report the results from 
SF-36 and the analyzing tool of the data by Orion Outcome Database. 
(Appendix A&B). The translation application phase in a proposal will 
put into practice the results found in research. The CNS will plan the 
application of applying practices of managing anemia for ESRD patients 
by working out the schedules of staff nurses for administrating the 
survey, evaluation of the lab results and scheduling the labs based on 
re-imbursement for these test, reviewing the results and changing doses 
for epogen per the algorithm established by the guidelines and approval 
of management. The CNS will also address different issues such as 
counseling, education and psychotropic drugs. The practice of managing 
anemia has to take into account a holistic approach to healthcare for 
the ESRD patient. (Hamilton & Hawley, 2005). The evaluation phase 
involves the CNS monitoring and reporting on outcomes, both clinical 
and financial. The CNS will report the results at monthly meetings 
attended by administration and physicians.
5. Feasibility of Implementation of Solution
    The professionalism, education, and clinical expertise of a CNS 
make them an ideal solution for the AMP. In Hamilton and Hawley the 
positive effects of a CNS managed AMP are worthwhile to the patient's 
overall health and the healthcare community's ability to met those 
needs.
    Tracking the quality of life outcomes of patients at various stages 
of the AMP provides greater insight into the effectiveness of the 
treatment program. In Hamilton and Hawley's research the patients' had 
pre and post results for comparison. This was done because the pre 
results gave a baseline for measuring movement negative or positive 
about the quality of life. The CNS can use the SF-36 survey and 
analysis tool Orion Outcome Database to repeat the research and 
duplicate the results showing improvements in the quality of life for 
ESRD patients. (Appendix A).
Section E: Evaluation Plan
1. Developing or Revising Outcome Measure
    The outcome measurement tool will be the Orion Outcomes Database 
designed to analyze data and based on results from research to evaluate 
whether or not the objective outcome goals were achieved. This will be 
used in this program to help the CNS evaluate the outcome goals and 
measure the trends for meeting those goals.
a. A copy of the measure needs to be included in the Appendix
    The results from Orion Outcomes Database (Appendix A) showing that 
there was a significant improvement in the quality of living for the 
ESRD patient who had the support of a CNS in an AMP. The conclusion of 
Hamilton and Hawley's research study (Appendix C) found that CNS 
interventions for the CKD patient population was seen in the first 3 
months as significant in physical improves in the patient's quality of 
life.
2. Determining Outcome Measure Value
    The outcome tool Orion Outcome Database (Appendix A) has a proven 
reliability for scientific research that is used to evaluate outcome 
goals. The results in Hamilton and Hawley study inspirited further 
research seen in this proposal. The results of Orion Outcome Database 
found in Hamilton and Hawley's research separated two components of 
physical and mental both scored then analyzed showing significant 
improvements with an AMP managed by a CNS. (Appendix C). An example of 
Hamilton and Hawley research would be seen the score of a patient 
experiencing a low quality of life mentally, but has a high score 
physically which would require intervention by the CNS. The next survey 
would be evaluated for the effectiveness of that intervention. This 
proposal would follow that same pattern and use those same tools to 
determining outcome measure values of the AMP.
a. Validity
    The validity that is in this plan is found in duplicating the 
efforts of Hamilton and Hawley's research. (Hamilton & Hawley, 2005). 
Validity should be obvious when a colleague looks at and measures 
outcomes from a study that is considered experts in the field. Examine 
the research and finding that it will show the same results when 
repeated proves validity. The measured outcome intended as seen when 
duplicating a study uses the same materials and methods. This is the 
aim of this proposal, to use the same research tools found in Hamilton 
and Hawley and duplicate the results to improve the quality of life for 
the ESRD patient. (Appendix A).
b. Reliability
    The Orion Outcome Database (Appendix A) is a proven method of 
analyzing data created by the survey. In Hamilton and Hawley's research 
study the measurement was significant when the results were analyzed by 
Orion Outcome Database showing an upward trend of improved quality of 
living for ESRD. Using this tool would be advantageous when reporting 
the progress of an AMP managed by a CNS to healthcare management. 
Management could see the results of improvements in a proven scientific 
method when using Orion Outcome Database and rely on that information 
to base a judgment on the AMP's success with a CNS in control of the 
operation.
    The CNS will take steps to analyze the results found at three month 
intervals based on Orion Outcomes Database (Appendix A) and crease a 
summary report for the healthcare management team and physicians using 
verbiage that helps to separate changes in physical and mental results. 
By separating the two fields the CNS report will more closely follow 
Orion's Outcome Database (Appendix A) to find the results of the 
effectiveness a CNS has on an AMP.
c. Sensitivity to change
    This instrument has sensitivity issues: The survey results are 
simplistic for easy access, time constraints, and analyzing. The 
results seen in Hamilton and Hawley's study do not plan for 
complications, surgeries, declines in other co-morbidities, emotional 
stressors, and staffing problems. According to Burns and Grove, ``This 
assessment of reliability is irrelevant or only partially relevant to 
assessing the suitability or precision of measures selected because of 
their sensitivity to change within the individual over time''. (Burns & 
Grove, 2005, P.). This research was conducted using a simple survey SF-
36. The format made the SF-36 easy for the patients to compete quickly. 
The research information did not specify if the SF-36 survey was made 
available in English only, and therefore, an evaluation of 
appropriateness of language could not be evaluated. (Appendix B)
d. Appropriateness for use
    According to Burns and Grove appropriateness is shown by the 
partnerships established by following guidelines formulated by 
established and respectable organizations. In this proposal the 
partnership between the AMP guidelines and the recommended guidelines 
from the NKF/KDQOI lends support for appropriateness. (Burns & Grove, 
2005, P. 656).
3. Data Collection and Analysis
    Hamilton and Hawley's research used a SF-36 survey (Appendix B) to 
collect the data and Orion Outcome Database for analyzing a research 
because the tools used were respected and valid for measuring the 
quality of life. The CNS must use a product like SF-36 so that they can 
collect data from the patients in the AMP and analyze the data 
resulting in a report that shows outcome goals are being met by the 
program. The idea that a CNS is the key factor in a successful AMP will 
be decided by the healthcare organization based on the results from 
tools such as OOD. According to Burns and Grove, ``Data collection is 
the precise, systematic gathering of information relevant to the 
research purpose or the specific objectives, questions, or hypotheses 
of a study.'' Burns & Grove, 2005, P. 42).
4. Resources Needed
    This proposal would ask that the CNS role will be the Clinical 
Manager. The benefits of having an existing employee of the clinic are 
cost saving and decreases the time required for orientation to the 
facility. The requirements for the CNS will include existing duties of 
maintaining a safe environment for patients, training programs for 
staff and using an implementation plan to guide staff in learning this 
new method of nursing practice. The staff nurses will administer the 
SF-36 survey and monitor the location, scheduled time to provide SF-36 
survey's to participants, Submit to the CNS a completed survey, and 
make sure patients have an opportunity to fill out the SF-36 survey. 
The staff nurses are key stakeholders in compliance. These nurses have 
to add this responsibility to work loads that are already overwhelming. 
The nurses have to be able to locate the SF-36 survey easily, maintain 
a list of patients in the research project, schedule times for filling 
out the SF-36 survey initially, in 3 months, 6 months and 12 months. 
The SF-36 survey cost is $405. Orion Outcomes Database cost $500 for a 
license to use this product. The implementation of the AMP will be 
introduced in an in-service training program to staff nurses. The cost 
for training will include re-imbursement at the rate of pay per RN. RN 
Salaries range from $22/hr to $32/hr. The clinic has four staff RN's 
resulting in cost of 88/hr to 128/hr. The total amount of time 
projected to spend in training is 4 hours which will total 352/RN to 
413/RN. The records of this project must be kept appropriate in a time 
frame to support the outcome goals to measure change in the patients' 
quality of life by the CNS to plan interventions based on the results.
5. Feasibility of the Plan
    According to Burns and Groves, ``feasibility of using research 
findings in practice involves examining the three R's.'' The two that 
relate to this portion of the proposal are potential risks and 
readiness of those involved (Burns & Groves, 2005, P. 644). The 
potential risks of implementing this change are that the staff RN will 
not want to perform the task of handling the SF-36 surveys'. Staff may 
have problems staying organized and remembering when to hand out the 
SF-36 survey. In Hamilton and Hawley's research study this problem 
resulted in over half of the 79 participants dropped due to a lack of 
staff RN's making the SF-35 survey available and giving the SF-36 
survey to patients within the time frame set out by the study. The CNS 
will have to plan for interventions and training staff to make sure 
that this does not happen. The second R addresses the ability or timing 
of induction to staff ready to take on this task. A new RN trying to 
train in basic skills for the department is a poor candidate because 
this staff RN has so much to learn and adding a SF-36 survey to his or 
her schedule would not be wise. The CNS must evaluate the staff working 
in the clinic, what are the staff's strengths and weaknesses for 
conducting the survey.
Section F: Decision-Making Strategies
1. Maintenance of the Solution
    The need to communicate and collaborate with administration and 
staff nurses is required to maintain the CNS-managed AMP. The 
importance of close contact and direction will result in a positive 
outcome of the project, particularly the achievement of upward trends 
in patients' quality of life outcome. This innovation can be done 
through: staff development or educational program held monthly and 
hospital committees developing practices that are incorporation into 
established policies and/or procedures. It is essential that once a CNS 
is hired that the hospital management team review outcome goals 
provided by Orion Outcome Database, reports of hospitalization trends 
for ESRD, a reduction in hospital stays for ESRD patients to evaluate 
the effectiveness of this program.
2. Extending the Solution
    An annual evaluation of the results from research of report 
findings and measuring goals set out for the AMP will be a tool that 
management can use to make the decision to continue this program. A 
reevaluation of the CNS performance will be based on meeting outcome 
goals as seen in Orion Outcome Database results, hospital stay. The 
nurse manager in collaboration with the nurse educator would have to 
plan education and training sessions as new staff members were hired in 
the clinic. The development of an introduction program would be 
beneficial to this program and help the CNS provide training as new 
hires came into the clinic more easily.
3. Revising the Solution
    As the program is managed the CNS will be evaluating the 
effectiveness of the practices, reporting methods and measurement 
tools. As nursing research continues the CNS may want to incorporate 
new guidelines that would change protocols and algorithms. The solution 
to revising the solution would be done by a collaborative effort of 
evidence-based practice and input from key stakeholders.
4. Discontinuing the Solution
    It would be very difficult to discontinue an innovation that staff 
has acknowledged success. However, if the program continues to produce 
negative outcome, then it should be discontinued that will formally 
involved different departments in the hospital such as nursing, 
medicine, education, IT, human resources, and administration.
5. Plans for Work Setting and Professional Feedback
    The plans for work setting will be a clinic of ESRD patients 
receiving dialysis. Professional Feedback would be collected by way of 
a questionnaire from staff and the SF-36 survey from the patients. 
These two tools will help the CNS evaluate the effectiveness of this 
program.
References
    Best Practice, 2006, National Kidney Foundation, Kidney Disease 
Outcome Quality Indicators. Guiding principles for the KDOQI process. 
Retrieved 5/26/07 online: http://www.kidney.org/professionals/kdoqi/
index.cfm
    Eschbach, J. W., & Adamson, J. W. (1985). Anemia of end-stage renal 
disease (ESRD). Kidney International, 51, 622-630.
    Frimat, L., Ayav, C. L., Panescu, V., Cordebar, N., Briancon, S., & 
Kessler, M. (2004). Early referral to a nephrologist is associated with 
better outcomes in type 2 diabetes patients with end-stage renal 
disease. Diabetes Metabolites, 30, 67-74.
    Hamilton, R., & Hawley, S. (2006) Quality of life outcomes related 
to anemia management of patients with chronic renal failure. Nursing 
Center, (Vol 20 is. 3 PP 139-143).
    Kimmel, P. L., & Patel, S. S. (2006). Quality of life in patients 
with chronic kidney disease: Focus on end-stage renal disease treated 
with hemodialysis. Seminars in Nephrology, (Vol. 26, PP. 68-79).
    Kulzer, P., Schaefer, R. M., Krahn, R., Schaefer, L., & Heidland, 
A. (1994). Effectiveness and safety of recombinant human erythropoietin 
(r-HuEPO) in the treatment of chronic renal failure in non dialysis 
patients.
    Lipschitz D. (2003) Medical and functional consequences of anemia 
in the elderly. Journal of American Geriatric Society (vol. 51(3): is. 
10). Retrieved 6-3-07 online: http://www.americangeriatrics.org/search.
    National Anemia Action Council. (2002) Anemia: Hidden epidemic. 
Retrieved June 4, 2007. Online: http://www.anemia.org/.
    National Institutes of Health. Healthy people 2010. Retrieved June 
3, 2007. Online: http://www.healthypeople.gov/.
    National Kidney Foundation, Inc. Kidney disease outcomes quality 
initiative: Guidelines for anemia of chronic kidney disease. 2001. 
Retrieved June 2, 2007. Online http://www.kidney.org/.
    Obrador, G. T., Ruthazer, R., Port, F. K., Held, P. J., & Pereira, 
B. G. (1997). Markers of quality of pre-ESRD care among patients 
starting dialysis in the U.S.Journal of the American Society of 
Nephrology, 8(145A)
    Pruett, B., Johnson, S., & O'Keefe, N. (2007). Improving IV iron 
and anemia management in the hemodialysis setting: A collaborative CQI 
approach. Nephrology Nursing Journal, (34 (2), pp. 206-213). Retrieved 
6/2/07 on-line http://web.ebscohost.com/ehost/
detail?vid=9&hid=15&sid=a039dc14-4602-45c7-b252-c6481ca788df%40SRCSM2
    Robbins, K. C., Kerhulas, S., Senger, J. M., & Fishbane, S. (1997). 
Iron management in ESRD and the role of the nephrology nurse. ANNA 
Journal, (Vol. 24, PP. 265-274).
    Sowers J, McClellan W, Schoolwerth A. (2005) An Educational 
Monograph. Timing is everything; A proactive approach to CKD 
management. AdvancMed, LLC.; (vol. pp 1-44). Retrieved June 3, 2007 on-
line http://www.advancmed.org/edu.php.
    Van Wyck, D. (2000). Lessons from NKF-DOQI: Iron management. 
Seminars in Nephrology, (Vol. 20, PP. 330-334). Retrieved 5/14/07 on-
line at www.Kidney.org.
    Ware J, Kosinski M. (2001) Interpreting SF-36 Summary Health 
Measures: A response. Quality of Life Research (is. 10: pp 405-413). 
Retrieved June 4, 2007 on-line http://www.sf-36.org/.
Appendix A
SF-36v2TM and SF-12v2TM Health Surveys Offer 
        Substantial Improvements)
    New versions of the SF-36 (SF-36v2TM) and SF-12 (SF-
12v2TM) Health Surveys, developed by scientists at Quality 
Metric Incorporated and collaborators, have been shown to produce 
substantial improvements over the originals. Improvements in item 
wording and format and a 6-fold increase in the ranges of scores 
covered were achieved for both surveys without increasing respondent 
burden. Survey developers, with over 10 years of experience in health 
outcomes measurement, recommend adoption of the SF-36v2TM or 
SF-12v2TM for clinical trials, disease management, risk 
prediction, population monitoring, and other studies where scientific 
validity and precise measurement are required. New up-to-date norms and 
guidelines are available for maintaining backward comparability with 
studies published to date, providing complete standardization between 
the surveys and allowing for comparison of data sets for trend 
analyses.
    Used successfully in more than 600 randomized clinical trials 
reported in over 240 scientific and medical journals, the SF-36, SF-
36v2TM, SF-12, SF-12v2TM, and SF-8TM 
are proven responsive in 44 disease conditions and are accepted by the 
FDA as proof of benefit for improved functioning and other patient-
reported outcomes. Additionally, the SF-36v2 and the SF-12v2 have been 
adopted as the standard of measurement by key government agencies, 
including the Agency for Healthcare Research and Quality (AHRQ), which 
has adopted use of the SF-12v2 for the nationally significant Medical 
Expenditure Panel Study (MEPS).

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Improvements Include:
    After more than 10 years of testing, new versions of the SF- (SF-
36v2TM) and SF-12 (SF-12v2TM) Health Surveys 
were published to correct deficiencies that had been identified in the 
original versions. Improvements, which are documented in the SF-36v2 
user's manual (Ware, Kosinski and Dewey, 2000) and in the SF-12v2 
user's manual (Ware, Kosinski, Turner-Bowker and Gandek, 2002) were 
implemented after careful study using both qualitative and quantitative 
methods in the US and other countries.
    Briefly, the SF-36v2 and SF-12v2 improvements include:

      better instructions and questionnaire items to shorten 
and simplify the wording and make them more familiar and less 
ambiguous;
      an improved layout for questions and answers in the self-
administered forms that makes it easier to read and complete, and that 
reduces missing responses;
      greater comparability with translations and cultural 
adaptations widely-used in the U.S. and in other countries;
      five-level responses in place of dichotomous response 
choices to greatly increase the range and precision of scores.

    As shown in the figure, a 6-fold increase in the range covered by 
the SF-12v2 Role-physical functioning scale was achieved. As documented 
in the new SF-12v2 and SF-36v2 user's manuals, comparable improvements 
were achieved for both role scales in both v2 forms. Specifically, the 
adoption of 5-choice (over dichotomous) response categories for items 
measuring both physical and emotional role functioning led to 
substantial increases in precision as indicated by the number of levels 
measured as well as the internal-consistency reliability of those 
scales for both SF-36 and SF-12 forms. Among the practical implications 
are virtual eliminations of the ``floor'' effects and substantial 
reductions in the ceiling effects for both SF-36v2 and SF-12v2 role 
functioning scales, in comparison with the original v1.
    In the figure, norm-based scoring (NBS) algorithms are used to 
achieve a mean and SD that are 50 and 10, respectively, for both v2 
measures to be comparable with SF-36v1 and SF-12v1. As explained in the 
user's manuals, item response theory (IRT) thresholds are used in the 
figure to show the differences in ranges covered by v1 and v2 items in 
a large representative sample of the general US population in 1999 (see 
the SF-12 user's manual for more information).
    Quality Metric's SFTM Generic Health Surveys (SF-36, 
SF-36v2TM, SF-12, SF-12v2TM, and SF-
8TM Health Surveys) can be scored online accurately, 
securely, and reliably now, with exclusive new desktop scoring software 
set for launch in early 2004.
    http://www.sf-36.org/community/SF36v2andSF12v2.shtml
Appendix B
                 The SF-36v2TM Health Survey
Instructions for Completing the
    Please answer every question. Some questions may look like others, 
but each one is different. Please take the time to read and answer each 
question carefully by filling in the bubble that best represents your 
response.
1. In general, would you say your health is:
   Excellent      Very good           Good           Fair           Poor
2. Compared to one year ago, how would you rate your health in general 
        now?
 Much better now than   Somewhat better now   About the same as     Somewhat worse now than  Much worse now than
      one year ago     than one year ago          one year ago             one year ago          one year ago
3. The following questions are about activities you might do during a 
        typical day. Does your health now limit you in these 
        activities? If so, how much?
                               Yes, limited   Yes, limited       No, not
                                    a lot       a little     limited at
                                                                    all
        a)  Vigorous activities, such as running, lifting heavy 
        objects, participating in strenuous sports
        b)  Moderate activities, such as moving a table, pushing a 
        vacuum cleaner, bowling, or playing
        c) Lifting or carrying groceries
        d) Climbing several flights of stairs
        e) Climbing one flight of stairs
        f) Bending, kneeling, or stooping
        g) Walking more than a mile
        h) Walking several hundred yards
        i) Walking one hundred yards
        j) Bathing or dressing yourself
Friday, June 22, 2007


Page 1 of 4

  SF-36v2TM  1999 QualityMetric, Inc. All Rights Reserved.
4. During the past 4 weeks, have you had any of the following problems 
        with your work or other regular daily activities as a result of 
        your physical health?
                                     All of the     Most of the     Some of the     A little of     None of the
                                          time            time            time        the time            time
        a)  Cut down on the amount of time you spent on work or other 
        activities
        b)  Accomplished less than you would like
        c)  Were limited in the kind of work or other activities
        d)  Had difficulty performing the work or other activities (for 
        example, it took extra effort)
5. During the past 4 weeks, have you had any of the following problems 
        with your work or other regular daily activities as a result of 
        any emotional problems (such as feeling depressed or anxious)?
                                    All of the     Most of the     Some of the     A little of     None of the
                                         time            time            time        the time            time
    a) Cut down on the amount of time you spent on work or other 
activities
    b) Accomplished less than you would like
    c) Did work or other activities less carefully than usual
6. During the past 4 weeks, to what extent has your physical health or 
        emotional problems interfered with your normal social 
        activities with family, friends, neighbors,
        Not at all               Slightly             Moderately            Quite a bit              Extremely
Friday, June 22, 2007
                                                            Page 2 of 4
  SF-36v2TM  1999 QualityMetric, Inc. All Rights Reserved.
7. How much *bodily* pain have you had during the *past 4 weeks*?
              None              Very mild                   Mild        Moderate Severe            Very severe
8. During the *past 4 weeks*, how much did *pain* interfere with your 
        normal work (including both work outside the home and 
        housework)?
       Not at all        A little bit          Moderately         Quite a bit          Extremely
9. These questions are about how you feel and how things have been with 
        you during the past 4 weeks. For each question, please give the 
        one answer that comes closest to the way you have been feeling. 
        How much of the time during the past 4 weeks . . .
                                     All of the     Most of the     Some of the     A little of     None of the
                                          time            time            time        the time            time
    a) did you feel full of life?
    b) have you been very nervous?
    c) have you felt so down in the dumps nothing could cheer you
    d) have you felt calm and peaceful?
    e) did you have a lot of energy?
    f) have you felt downhearted and depressed?
    g) did you feel worn out?
    h) have you been happy?
    i) or groups? did you feel tired?
10. During the past 4 weeks, how much of the time has your physical 
        health or emotional problems interfered with your social 
        activities (like visting friends, relatives, etc.)?
   All of the time       Most of the time       Some of the time      A little of the time    None of the time
      
Friday, June 22, 2007
                                                            Page 3 of 4
  SF-36v2TM  1999 QualityMetric, Inc. All Rights Reserved.
11. How TRUE or FALSE is *each* of the following statements for you?
        Definitely            Mostly true             Don't know           Mostly false             Definitely
    a) I seem to get sick a little easier than other people
    b) I am as healthy as anybody I know
    c) I expect my health to get worse
    d) My health is excellent
              THANK YOU FOR COMPLETING THIS QUESTIONNAIRE!
Friday, June 22, 2007
                                                            Page 4 of 4
  SF-36v2TM  1999 QualityMetric, Inc. All Rights Reserved.
Appendix CQuality of Life Outcomes Related to Anemia Management of 
Patients with Chronic Renal Failure
RETAHAMILTON MSN, RN, CNS, APRN, BC
SHEILA HAWLEY MSN, RN, CNS, APRN, BC, CRNI Clinical Nurse Specialist: 
        The Journal for Advanced Nursing Practice
May/June 2006
Volume 20Number 3
Pages139-14
    Purpose: The purpose of this study was to evaluate the impact of a 
clinical nurse specialist-managed outpatient anemia management program 
on quality of life for patients with anemia related to chronic kidney 
disease.
    Description of the study: A retrospective study was conducted using 
information from the Medical Outcomes Short Form 36 Item Health Survey, 
which is completed by patients with anemia at their initial, 3-month, 
6-month, and 12-month visits, and annually thereafter. Thirty-four 
patients completed the 3-month survey, 19 completed the 6-month survey, 
and 10 completed the 12-month survey.
    Outcomes: There was a statistically significant increase in quality 
of life indicators at the 3 and 6 months' interval. The increase in 
physical and decrease in mental indicators were not substantiated 
through the 12-month interval.
    Conclusion: Quality of life was significantly improved for patients 
in a clinical nurse specialist-managed outpatient anemia management 
program. The National Anemia Action Council and Healthy People 2010 
have identified anemia as a significant public health concern. At least 
3.4 million Americans have been diagnosed with anemia, and millions 
more may be undiagnosed or at increased risk of developing anemia.\1,2\ 
Anemia is associated with lower functional ability, self-care deficits, 
and depression. Even though the body tries to compensate for the 
effects of anemia, almost every organ system is eventually affected. 
Even mild anemia adversely affects the patient's quality of life.\3\
    Many studies have been conducted which consider the impact of 
anemia on patients' quality of life. Decline in physical functioning 
because of anemia has an adverse effect on the patient's quality of 
life. Several clinical trials in young patients with renal disease or 
undergoing chemotherapy for various malignancies have reported a strong 
positive correlation between quality of life score and hemoglobin 
concentrations. Available data have also shown that overall prognosis 
is improved by successfully managing and correcting anemia in patients 
with chronic diseases such as congestive heart failure and end-stage 
renal disease.\3\
    The purpose of this retrospective study was to determine the impact 
of a clinical nurse specialist (CNS)-managed anemia management program 
(AMP) on patient quality of life. Patients treated in the AMP have 
anemia related to chronic kidney disease (CKD). 'As kidney function 
declines, the likelihood of anemia associated with erythropoietin 
deficiency increases because the diseased kidneys are unable to produce 
sufficient quantities of EPO. Frequently, anemia manifests early in the 
spectrum of CKD and worsens over time.\5\ Effective treatment of the 
anemia of CKD improves survival, decreases morbidity, and increases 
quality of life.\4\ Quality of life can be difficult to define because 
it means different things to different people. For the purpose of this 
study, we will be looking at health-related quality of life because it 
impacts every aspect of a person's life. Health-related quality of life 
usually refers to aspects of our lives that are dominated or 
significantly influenced by our mental or physical well-being.\6\ The 
specific aim of this study was to test the following research question: 
Do patients treated in a CNS-managed AMP for patients with anemia 
related to CKD experience a significant increase in quality of life?
    The CNS who manages the AMP also wanted to test her hypothesis that 
patients treated in the AMP for anemia related to CKD experience the 
greatest improvement in quality of life during the first 3 months of 
treatment. The CNS speculates that after 3 months, the patients 
maintain this improved level of functioning, but she expects that the 
findings from the study will show that patients maintain or show a 
slight decrease in functioning. The CNS attributes this to patients 
with anemia being so weak when they first begin treatment and improve 
so drastically that, after a few months, they do not remember how 
physically and mentally weak they were when starting treatment.
    Evidence-based treatment protocols for patients with anemia treated 
in the AMP include intravenous iron sucrose and subcutaneous injections 
of erythropoietin. Individual dosages are adjusted with each visit 
based on the patient's hemoglobin level and iron studies. Patients are 
seen in the AMP every 1 to 2 weeks, depending on their hemoglobin and 
iron levels. If patients are severely anemic and symptomatic, they may 
receive a transfusion of packed red blood cells. These treatment 
protocols are consistent with recommendations from multiple sources 
including the National Anemia Action Council and the National Kidney 
Foundation.\1,4\
    As the CNS developed the AMP, attention was given to 
nonpharmacological interventions, such as patient education regarding 
their disease process, symptom management, nutrition, and exercise. 
Patients receive written and verbal education on their initial visit. 
During each follow-up visit, ongoing education is provided. Patients 
are given a thorough physical assessment at each visit, including 
weight, vital signs, and hemoglobin monitoring. Patients identified 
point of care testing for hemoglobin levels as one of the most popular 
interventions initiated by the CNS. Hemoglobin levels are measured by 
the AMP staff in the clinic, which saves the patient the time and 
inconvenience of going to the laboratory for a blood draw. The CNS and 
staff of the AMP are also a source of support and encouragement for the 
patients and the family members who accompany them to the clinic.
DESIGN
    This retrospective study was conducted in an outpatient AMP. The 
program is actively managed by a CNS who treats patients with anemia 
related to CKD. The average age of patients treated in the AMP is 71 
years. Patients in the AMP are asked to complete version 2.0 of the 
Medical Outcomes Short Form 36 Item Health Survey (SF-36) to monitor 
quality of life indicators. The SF-36 is given to the patient by the 
AMP staff during the patient's initial visit with a brief explanation 
of its purpose and directions for completing it. The SF-36 is self-
administered and is completed by the patients with anemia at their 
initial, 3-month, 6-month, and 12-month visits, and annually 
thereafter. Thirty-four patients completed the 3-month survey, 19 
completed the 6-month survey, and 10 completed the 12-month survey.
Sample
    Tracking the quality of life outcomes of patients at various stages 
of the AMP provides greater insight into the effectiveness of the 
treatment program. The patients' pretreatment results were compared 
with their post treatment results. For a patient's results to be 
included, they must have completed each required survey. Those patients 
who had completed a12-month survey have also completed the initial, the 
3-month, and the 6-month surveys before being included in the study. 
Patients included in the 6-month evaluation group have completed the 
initial, the 3-month, and the 6-month surveys. Patients included in the 
3-month evaluation have completed both the initial and the 3-month 
surveys. Information from the SF-36 surveys is put into a software 
program called the Orion Outcomes Database which stores and analyzes 
the data. There were 73 patients in the Orion Outcomes Database, who 
had completed the initial survey. Of these 73 patients, 34 had 
completed both the initial and the 3-month surveys, 19 had completed 
the initial, the 3-month, and the 6-month surveys, and 10 had completed 
all the required surveys up to 12-months.
    The SF-36 is the assessment tool used for monitoring health-related 
quality of life issues for patients in the AMP because it is a useful 
and reliable instrument for assessing quality of life in patients with 
many chronic conditions including chronic renal disease.\8\ The SF-36 
is self-administered and takes approximately 5 minutes to complete and 
is divided into 8 dimensions which include Physical Functioning, Role 
Physical, Bodily Pain, General Health, Vitality, Social Functioning, 
Role Emotional, and Mental Health. There are 36 outcomes assessed under 
these 8 dimensions. The dimensions of the SF-36 are scored on a range 
from 0 (the worst score) to 100 (the best score).\8\
    Version 2.0 of the SF-36 is an updated version that includes 2 
summary measures. These summary measures are the Physical Component 
Score, which is a summary score of all the physical components, and the 
Mental Component Score, which is a summary of all the mental component 
scores of the SF-36. Using these 2 summary components makes 
interpreting outcomes easier because it reduces the number of 
statistical comparisons necessary to capture differences in health 
status, offers greater precision for measuring general physical and 
mental health outcomes, and has more straightforward interpretation of 
physical and mental health scores.\6\
    The SF-36 has been used in multiple studies to evaluate quality of 
life issues for patients with chronic diseases, including anemia. One 
such study was conducted by a group of nephrologists in Spain using the 
SF-36 to evaluate health-related quality of life in chronic allograft 
nephropathy patients with anemia. The chronic allograft nephropathy 
patients' anemia was treated with recombinant human erythropoietin.\9\ 
Findings related to quality of life for the chronic allograft 
nephropathy patients with anemia were similar to those for other 
patients with anemia treated with erythropoietin. The poor health-
related quality of life of patients with chronic allograft nephropathy 
and anemia improved with erythropoietin treatment. This improvement 
varied from moderate to large for various components on the SF-36.\9\
    The construct validity of the SF-36 has been tested by factor 
analysis using both psychometric and clinical tests of validity. The 
SF-36 has been tested for internal consistency reliability by Cronbach 
coefficient alpha and has been translated for use in more than 50 
countries. The SF-36 continues to be a valuable tool which is widely 
used to compare health-related quality of life outcomes for general and 
specific populations. One limitation of the SF-36 is that the patient 
must be able to read in order to self-administer the survey. For 
patients who are unable to read, the tool could be administered orally 
by a staff member if necessary.\10\ Staff members in the AMP have not 
orally administered the SF-36 to their patients with anemia. Orally 
administering the SF-36 to patients in the AMP who need assistance 
should be considered as a means of increasing survey completion.
    Information from the completed SF-36 forms is entered into the 
Orion Outcomes Database by a staff member in the AMP. The Orion 
Outcomes Database not only stores the data from the SF-36 surveys but 
also provides an analysis of the data. The Orion Outcomes analyzes the 
data, and statistical significance is calculated using the counts, 
means, and SDs of the 2 different samples.\11\ A P value is identified 
for each dimension of the SF-36 survey and for the 2 summary measures 
with a P value of the SF-36 survey and for the 2 summary measures with 
a P value of <.05 which is considered statistically significant.\11\
RESULTS
    The results of the study are summarized in Table 1. The Physical 
and Mental Component Scores for the 3-month, 6-month, and 12-month 
follow-up periods were compared with the patients' initial Physical and 
Mental Component Scores. For the 3-month period, 34 patients (n = 34) 
completed both the initial and the 3-month surveys. For the 6-month 
period, 19 patients (n = 19) had completed the initial and the 6-month 
surveys. For the 12-month period, 10 patients (n = 10) had completed 
all the required surveys.

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Table 1. Summary of SF-36
    Scores For the Physical Component Score, the Role Physical 
dimension had the greatest increase between the initial and the 3-month 
periods, with an mean increase of 5.82 ( P =.002). The Role Physical 
dimension relates to problems with work or other daily activities as a 
result of physical health issues.\6\ The greatest increase in physical 
functioning for the 6-month surveys was in the Bodily Pain dimension 
with a mean of 6.75 ( P =.002). Bodily pain evaluates the severity of 
pain and its effect on physical functioning.\6\ The greatest increase 
in physical functioning at 12 months was in the Role Physical dimension 
with a mean of 1.94 ( P =.231). During the 12-month survey, there was a 
decrease in the mean of 2 physical dimensions, General Health and 
Physical Functioning. Physical Functioning evaluates the patient's 
ability to perform basic activities such as bathing or dressing to the 
ability to perform the most vigorous activities without limitations. 
General Health evaluates the patients' perceptions of their personal 
health.\6\ The mean for all physical components for the 12-month survey 
were not statistically significant.
    For the Mental Component Scores, the Vitality dimension had the 
greatest increase between the initial and the 3-month periods, with a 
mean of 7.10 (P >= .001). The Vitality dimension relates to feeling 
tired and worn-out or full of pep and energy.\6\ The greatest increase 
in mental functioning from the initial to the 6-month surveys was in 
the Social Functioning dimension with a mean of 7.70 ( P = .009). 
Social Functioning evaluates the level of interference with normal 
social activities due to physical or emotional problems.\6\ The Mental 
Health dimension was the only mental health component which did not 
show a statistically significant change for the 6-month follow-up, with 
a mean of 2.85 ( P = .111). The greatest increase in mental functioning 
for the 12-month survey group was also in the Social Functioning 
imension with a mean of 2.64 ( P = .239). Again, the findings for the 
12-month period were not statistically significant.
CONCLUSION
    Analysis of data from this retrospective study supports the 
hypothesis that patients treated in a CNS-managed AMP for anemia 
related to CKD experience the greatest improvement in quality of life 
during the first 3 months of treatment. The most rapid increase in 
functioning was during the first 3 months in both the Physical and the 
Mental Component Scores. During the next 3 months, however, the 
patients' quality of life did continue to improve but not as 
dramatically as during the first 3 months. The findings for the 12-
month survey showed a slight decrease in the Mental Component Score, 
which was not statistically significant, but due to the small sample 
size, these findings are inconclusive. The Physical Component Score 
components continued to show a slight increase even with the small 
sample size, although this increase was not statistically significant. 
Patients may have had difficulty with recall after several months of 
treatment; there may be progression of underlying disease and the 
influence of multiple chronic health problems and comorbidities. These 
factors may have accounted for lower scores at 12 months.
LIMITATIONS
    One limitation which may have impacted this study was lack of a 
power analysis. A power analysis would have determined the number of 
patients needed to detect if an increase in quality of life was due to 
anemia treatment. Information regarding a power analysis was not 
provided by the analysis database. Another limitation of the study 
relates to administration of the SF-36. There were incidents when the 
staff failed to make the SF-36 available to the patients for self-
administration at the designated intervals. There were also surveys 
that were excluded from the study due to missing data.
RECOMMENDATIONS
    Repeating this study with a larger sample may show a greater 
increase in the mean scores for both the Physical and the Mental 
Component Scores in each of the posttreatment time frames, especially 
the 12-month survey. A more consistent, orderly approach in the 
administration of the SF-36 would be beneficial in tracking the 
progress of patients in the AMP and increasing sample size for future 
studies. Continued education and encouragement should be provided to 
the AMP staff concerning the importance of making the SF-36 available 
to the patients at the appropriate times and checking the surveys for 
completeness of information. It may be beneficial for the staff to 
assist patients with limited reading ability by reading questions to 
the patient and by reviewing all surveys for completeness of 
information when collected from the patients. Repeating the study with 
a larger sample size and including longer treatment intervals could be 
very informative regarding the ongoing effectiveness of an AMP.
IMPLICATIONS FOR CNS PRACTICE
    Data have shown that overall prognosis is improved by successfully 
managing and correcting anemia of chronic disease whether it is related 
to CKD, cardiovascular disease, or cancer.\3\ This study shows that 
patients treated in a CNS-directed AMP for anemia related to CKD do 
experience improved quality of life. The knowledge, clinical expertise, 
and versatility of a CNS put the CNS in the ideal position to care for 
patients with anemia from various causes, not just those related to 
CKD. With the growing number of patient with anemia and the devastating 
effects that anemia has on patients' quality of life, the positive 
effects of the AMP are worthwhile to the patients and the healthcare 
community.
    The CNS who manages the AMP identified earlier referrals by primary 
care providers as the intervention with the greatest potential to 
positively impact quality of life for patients with anemia. Research 
supports the CNS's view. Symptoms of chronic renal failure appear late 
in the course of the disease, and earlier referral to a nephrologists 
can lead to better quality of life for patients with renal disease.\12\ 
The CNS has an opportunity to make a positive impact on patient 
outcomes by educating other members of the healthcare team, such as 
physicians, case managers, and diabetes educators, regarding the 
advantages of identifying and screening high-risk patients. Earlier 
screening can lead to earlier referral. With the continued increase in 
CKD and the anemia that accompanies it, organizations may find CNSs to 
be a valuable resource for managing this patient population. A CNS is 
well prepared and qualified to manage patients with chronic health 
problems, and the positive impact of a CNS-managed program need not be 
limited to anemia.
                               __________
References:
    1. National Anemia Action Council. Anemia: hidden epidemic. 2002. 
Available at: http://www.anemia.org/. Accessed June 4, 2005.
    2. National Institutes of Health. Healthy people 2010. Available 
at: http://www.healthypeople.gov/. Accessed June 13, 2005.
    3. Lipschitz D. Medical and functional consequences of anemia in 
the elderly. J Am Geriatr Soc. 2003;51(3):s10-s13.
    4. National Kidney Foundation, Inc. Kidney disease outcomes quality 
initiative: guidelines for anemia of chronic kidney disease. 2001. 
Available from http://www.kidney.org/. Accessed June 26, 2005.
    5. Sowers J, McClellan W, Schoolwerth A. An Educational Monograph. 
Timing is everything; a proactive approach to CKD management. 
AdvancMed, LLC. 2005;1-44. Available from http://www.advancmed.org/
edu.php. Accessed September 5, 2005.
    6. Ware J. SF-36 Health Survey Manual and Interpretation Guide. 
Boston: Nimrod Press; 1997.
    7. National Association of Clinical Nurse Specialists. Statement on 
Clinical Nurse Specialist Practice and Education. Harrisburg, Pa: 
National Association of Clinical Nurse Specialists; 2004.
    8. Loos C, Briancon S, Frimat L, Hanesse B, Kessler M. Effect of 
end-stage renal disease on the quality of life of older patients. J Am 
Geriatr Soc. 2003;51:229-233.
    9. Rebollo P, Baltar J, Campistol J, Ortega T, Ortega F. Quality of 
life of patients with chronic renal allograft rejection and anemia. J 
Nephrol. 2004;17:531-536. Available at http://www.sin-italy.org//
jnonline/vol17n4/531.html. Accessed June 13, 2005.
    10. Ware J, Kosinski M. Interpreting SF-36 summary health measures: 
a response. Quality of Life Research. 2001;10:405-413. Available at 
http://www.sf-36.org/. Accessed June 14, 2005.
    11. Orion Software Development Outcomes Data Management System: 
Users Manual. Longmont, Co: Orion Software Development; 2001.
    12. Frimat L, Loos-Ayav C, Panescu V, Cordebar N, Briancon S, 
Kessler M. Early referral to a nephrologist is associated with better 
outcomes in type 2 diabetes patients with end-stage renal disease. 
Diabetes Metab. 2004;30:67-74.

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Appendix DCNS AMP Projected Budget------------------------------------------------------------------------


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    Proposal CNS managed AMP /07

                                 
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