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49–981 2010

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 

SANDER M. LEVIN, Michigan 

JIM MCDERMOTT, Washington 

JOHN LEWIS, Georgia 

RICHARD E. NEAL, Massachusetts 

MICHAEL R. MCNULTY, New York 

JOHN S. TANNER, Tennessee 

XAVIER BECERRA, California 

LLOYD DOGGETT, Texas 

EARL POMEROY, North Dakota 

STEPHANIE TUBBS JONES, Ohio 

MIKE THOMPSON, California 

JOHN B. LARSON, Connecticut 

RAHM EMANUEL, Illinois 

EARL BLUMENAUER, Oregon 

RON KIND, Wisconsin 

BILL PASCRELL, JR., New Jersey 

SHELLEY BERKLEY, Nevada 

JOSEPH CROWLEY, New York 

CHRIS VAN HOLLEN, Maryland 

KENDRICK MEEK, Florida 

ALLYSON Y. SCHWARTZ, Pennsylvania 

ARTUR DAVIS, Alabama 

JIM MCCRERY, Louisiana 

WALLY HERGER, California 

DAVE CAMP, Michigan 

JIM RAMSTAD, Minnesota 

SAM JOHNSON, Texas 

PHIL ENGLISH, Pennsylvania 

JERRY WELLER, Illinois 

KENNY HULSHOF, Missouri 

RON LEWIS, Kentucky 

KEVIN BRADY, Texas 

THOMAS M. REYNOLDS, New York 

PAUL RYAN, Wisconsin 

ERIC CANTOR, Virginia 

JOHN LINDER, Georgia 

DEVIN NUNES, California 

PAT TIBERI, Ohio 

JON PORTER, Nevada 

JANICE MAYS, Chief Counsel and Staff Director 

BRETT LOPER, Minority Staff Director 

SUBCOMMITTEE ON HEALTH 

FORTNEY PETE STARK, California, Chairman 

LLOYD DOGGETT, Texas 

MIKE THOMPSON, California 

RAHM EMANUEL, Illinois 

XAVIER BECERRA, California 

EARL POMEROY, North Dakota 

STEPHANIE TUBBS JONES, Ohio 

RON KIND, Wisconsin 

DAVE CAMP, Michigan 

SAM JOHNSON, Texas 

JIM RAMSTAD, Minnesota 

PHIL ENGLISH, Pennsylvania 

KENNY HULSHOF, Missouri 

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 printed and electronic versions of the hearing record, the process of converting 

between various electronic formats may introduce unintentional errors or omissions. Such occurrences are inherent in the current publication process and should diminish as the process 

is further refined. 


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C O N T E N T S 

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 


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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:] 


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ADVISORY 

FROM THE COMMITTEE ON WAYS AND MEANS 

SUBCOMMITTEE ON HEALTH 

FOR IMMEDIATE RELEASE CONTACT: (202) 225 093943 

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 


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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: 

Please Note: Any person(s) and/or organization(s) wishing to submit for the hearing record must follow the appropriate link on the hearing page of the Committee 

website and complete the informational forms. From the Committee homepage, 

http://waysandmeans.house.gov, select ‘‘110th Congress’’ from the menu entitled, 

‘‘Committee Hearings’’ (http://waysandmeans.house.gov/Hearings.asp?congress=18). 

Select the hearing for which you would like to submit, and click on the link entitled, 

‘‘Click here to provide a submission for the record.’’ Once you have followed the online instructions, completing all informational forms and clicking ‘‘submit’’ on the 

final page, an email will be sent to the address which you supply confirming your 

interest in providing a submission for the record. You MUST REPLY to the email 

and ATTACH your submission as a Word or WordPerfect document, in compliance 

with the formatting requirements listed below, by close of business Tuesday, July 

10, 2007. Finally, please note that due to the change in House mail policy, the U.S. 

Capitol Police will refuse sealed-package deliveries to all House Office Buildings. 

For questions, or if you encounter technical problems, please call (202) 225–1721. 

FORMATTING REQUIREMENTS: 

The Committee relies on electronic submissions for printing the official hearing record. As always, submissions will be included in the record according to the discretion of the Committee. 

The Committee will not alter the content of your submission, but we reserve the right to format 

it according to our guidelines. Any submission provided to the Committee by a witness, any supplementary materials submitted for the printed record, and any written comments in response 

to a request for written comments must conform to the guidelines listed below. Any submission 

or supplementary item not in compliance with these guidelines will not be printed, but will be 

maintained in the Committee files for review and use by the Committee. 

1. All submissions and supplementary materials must be provided in Word or WordPerfect 

format and MUST NOT exceed a total of 10 pages, including attachments. Witnesses and submitters are advised that the Committee relies on electronic submissions for printing the official 

hearing record. 

2. Copies of whole documents submitted as exhibit material will not be accepted for printing. 

Instead, exhibit material should be referenced and quoted or paraphrased. All exhibit material 

not meeting these specifications will be maintained in the Committee files for review and use 

by the Committee. 

3. All submissions must include a list of all clients, persons, and/or organizations on whose 

behalf the witness appears. A supplemental sheet must accompany each submission listing the 

name, company, address, and telephone and fax numbers of each witness. 

Note: All Committee advisories and news releases are available on the World 

Wide Web at http://waysandmeans.house.gov 

The Committee seeks to make its facilities accessible to persons with disabilities. 

If you are in need of special accommodations, please call 202–225–1721 or 202–226– 

3411 TTD/TTY in advance of the event (four business days notice is requested). 

Questions with regard to special accommodation needs in general (including availability of Committee materials in alternative formats) may be directed to the Committee as noted above. 

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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. 


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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. 


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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 paVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00055 Fmt 6633 Sfmt 6602 E:\HR\OC\49981.XXX 49981

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tients 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 conVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00056 Fmt 6633 Sfmt 6602 E:\HR\OC\49981.XXX 49981

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sistent 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 


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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. 


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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 

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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 


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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 AfricanAmerican 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. 


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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. 


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[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 


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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 


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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. 


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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 


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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. 


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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 


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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 


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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 nonrenal 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 apVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00074 Fmt 6633 Sfmt 6602 E:\HR\OC\49981.XXX 49981

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propriate 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:] 


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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 endstage renal disease drugs. 

As of January 1, 2006, CMS set the reimbursement for all endstage 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. 


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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:] 


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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 


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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:] 


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Statement of John K. Jenkins, M.D., Director, Office of New Drugs, Center 

for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 


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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. 


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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. 


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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 

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$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 

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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 

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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 


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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 


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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. 


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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. 


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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. 


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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 longawaited 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. 


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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 


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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. 


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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, nonprofit. 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 dialyVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00132 Fmt 6633 Sfmt 6602 E:\HR\OC\49981.XXX 49981

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sis 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? 


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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. 


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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 shortterm, 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 


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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 

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beling. 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. 


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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 


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1www.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. 3Singh 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 4Drueke 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 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. 6http://www.anemia.org/professionals/resources/slides/ 

7Phrommintikul 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 

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. 

• 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

• 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. 

• We should accept that the proven benefit of erythropoetic stimulating agent 

(ESA) therapy is in preventing blood transfusions. Although, the FDA has recently 


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8www.fda.gov/OHRMS/DOCKETS/AC/07/briefing/2007-4301b2-02-FDA.pdf 

9 New York Times, May 14, 2007 Late Edition—Final, Section A, Page 18, Column 1 

10Marlene Busko Is Medicare Reimbursement Policy for Erythropoietin in ESRD Flawed? 

http//www.medscape.com/viewarticle/550594 11The 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’’. 

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. • 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. 

• 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. 

• The study by Thamer and co-workers documents the overuse of epoetin in forprofit 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, faciliVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00140 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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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 13Weiner 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 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 16Tonks 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 17http://www.google.com/search?q=epogen+rebates+2007&hl=en&start=20&sa=N 18Steinman 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.) 19Dyer O. Journal rejects article after objections from marketing department. BMJ. 2004 Jan 

31;328(7434):244. 

tates 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. 

• 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 overutilization 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 overutilization 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


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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. 21Singh AK et al Letter to JAMA. 2007. In press. 

• 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. 

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. 

• 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. 

f 

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 


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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 


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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 difVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00144 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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ferent 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 decisionmaking 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. 


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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: 


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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. 

f 

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 


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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. 


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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. 


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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. 


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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) 

f 

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 


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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 paVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00152 Fmt 6633 Sfmt 6602 E:\HR\OC\49981.XXX 49981

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tient 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 


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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? 


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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? 


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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. 


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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— 


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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? 


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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. Endstage 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 


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1Singh 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; Dru ̈ eke 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. 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. 

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

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 FDAapproved 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


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4 Amgen data on file. 

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). 6 USRDS Annual Data Report 2006. 

7Sarnak MJ. Cardiovascular complications in chronic kidney disease. Am J Kidney Dis. 

41(S5):S11–S17. 8Fishbane S and Berns JS. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Intt. 2005;68(3):1337–43. 9Wolfe 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 

Continued 

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. 

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-KDOQITM) 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

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. 

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. 

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


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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. 10Gilbertson 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. 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. 

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. 

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 crosssectional, 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

When hemoglobin levels exceed the upper bound, physicians adjust ESA doses 

downward, with the objective of returning hemoglobin levels to within target. 


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14 Amgen data on file. 15 USRDS Annual Data Report 2006. 16Zhang Y, Thamer M, Stefanik K, et al. Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis. 2004;44:866–76. 

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

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

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. 

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. 


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17 USRDS 2006 Annual Data Report, CMS’ 2005 Annual Report ESRD Clinical Performance 

Measures Project. 18 USRDS 2006 Annual Data Report; Ba ́ ra ́ny P, Divino Filho JC, Bergsto ̈rm 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. 19 USRDS 2006 Annual Data Report. 20 USRDS 2006 Annual Data Report. 21 Berenson and Pollack The New York Times, May 9, 2007. 22Pisoni 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. 23Goodkin 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. 24Medicare Payment Advisory Commission. Report to the Congress: Medicare Payment Policy. 

March 2007. 

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. 

• 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

• 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. AfricanAmericans in particular receive higher ESA doses to achieve similar hemoglobin 

levels as other patient subgroups.19

• 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

• 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. 

• 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

• 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. 

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

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 outof-target hemoglobin levels, and there is no compelling evidence of inappropriate utilization. However, the announcement for this hearing suggested the existing MediVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00164 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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25Medicare Payment Advisory Commission. Report to the Congress: Medicare Payment Policy. 

March 2007. 26Department 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. 27 Amgen data on file. 28Ofsthun 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. 30 Amgen data on file. 

care 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

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. 

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

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

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. 

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. 


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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. 

f 


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1 Centers for Medicare and Medicaid Services, 2005 ANNUAL REPORT ESRD CLINICAL 

PERFORMANCE MEASURES PROJECT 35&38 (2005). 

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. 

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 reVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00167 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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2Statement of Leslie V. Norwalk, Acting Administrator, Centers for Medicare and Medicaid 

Services, Before the House Committee on Ways and Means, December 06, 2006. 

gard 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. 

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 atVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00168 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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tainment, 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 patientcare 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 


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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. 

f 

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. 


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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 prodVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00171 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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ucts, 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. 

Year Consumer Price 

Index CPI 

Medical Care 

Component Hospital Update ESRD Composite 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% 


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Year Consumer Price 

Index CPI 

Medical Care 

Component Hospital Update ESRD Composite Rate 

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 

Statistics— 

Department of 

Labor 

Bureaus of Labor 

Statistics— 

Department of 

Labor 

Medicare .

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. 

f 

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. 


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• 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 


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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 

f 

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 


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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 manVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00176 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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agement 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, selfcare 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 


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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 manmade 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 apVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00178 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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pointment 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 reVerDate Nov 24 2008 13:57 Apr 08, 2010 Jkt 049981 PO 00000 Frm 00179 Fmt 6633 Sfmt 6621 E:\HR\OC\49981.XXX 49981

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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). 


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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 selfadministration 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. 


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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 


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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 


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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 


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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. 


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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/. 


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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 online 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 


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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 

one year ago 

Somewhat 

better now 

than one 

year ago 

About the 

same as one year ago 

Somewhat 

worse now than 

one year ago 

Much worse 

now than 

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 a lot Yes, limited a little No, not 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 

time 

Most of 

the time 

Some of 

the time 

A little of 

the time 

None of 

the 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 

time 

Most of 

the time 

Some of 

the time 

A little of 

the time 

None of 

the 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 


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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 

time 

Most of 

the time 

Some of 

the time 

A little of 

the time 

None of 

the 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 C Quality of Life Outcomes Related to Anemia Management of Patients with Chronic Renal Failure 


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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


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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 


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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. 

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). 


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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 highrisk patients. Earlier screening can lead to earlier referral. With the continued increase in CKD and the anemia that accompanies it, organizations may find CNSs 


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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 D 

CNS AMP Projected Budget 

Proposal CNS managed AMP /07 

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