Clinical and economic outcomes in Medicare beneficiaries with stage 3 or stage 4 chronic kidney disease and anemia: the role of intravenous iron therapy.
ABSTRACT Anemia in patients with chronic kidney disease (CKD) is associated with increased morbidity and mortality, decreased quality of life, and substantial health care costs. Iron therapy is recommended, usually in combination with an erythropoiesis-stimulating agent (ESA), in many CKD patients with anemia and low iron levels to raise hemoglobin levels to a range of 10 to 12 grams per deciliter; iron deficiency is defined by a ferritin score less than 100 micrograms (mcg) per liter and transferrin saturation (TSAT) less than 20%.
To examine the use of intravenous (IV) iron and its associated economic and clinical outcomes in Medicare beneficiaries with stage 3 or stage 4 CKD and anemia.
This was a retrospective cohort analysis using 2006 and 2007 Medicare 5% Standard Analytic Files (SAF). Use of therapy with IV iron and/or ESAs was identified among patients diagnosed with CKD and anemia. The study index quarter was the first quarter in 2006 during which the patient had primary or secondary diagnoses of both CKD and anemia. Based on the receipt of IV iron or ESA treatment in the index quarter, patients were classified into 1 of 4 treatment groups: IV iron and ESA; IV iron without ESA; ESA without IV iron; neither IV iron nor ESA. Therapy with oral iron was not measurable with this database. Clinical and economic outcomes, including the progression to advanced CKD stages, development of anemia, mortality, hospitalization, and net Medicare reimbursement (i.e., not including patient or supplemental plan contribution) for all-cause health care services, were examined for 1 year following the index quarter. Between-group differences were tested using Pearson chi-square for categorical variables and the Kruskal-Wallis nonparametric test for reimbursement. Multivariate logistic regression models were estimated to assess the associations of mortality, inpatient hospitalization, skilled nursing facility (SNF) admission, and hospice care with treatment regimen, controlling for patient demographic and clinical characteristics.
Of the 4,310 study patients with both CKD and anemia, 2,913 (67.6%) received neither IV iron nor ESA; 984 (22.8%) received ESA without IV iron; 277 (6.4%) received IV iron and ESA; and 136 (3.2%) received IV iron without ESA in the index quarter. Logistic regression analyses showed that patients receiving neither IV iron nor ESA (reference group) were at increased risk of death compared with patients receiving both IV iron and ESA (OR = 0.62, 95% CI = 0.42-0.90). Additionally, patients receiving neither IV iron nor ESA were more likely to be hospitalized compared with patients receiving both IV iron and ESA (OR = 0.66, 95% CI = 0.50-0.87), IV iron without ESA (OR = 0.55, 95% CI = 0.38-0.79), and ESA without IV iron (OR = 0.73, 95% CI = 0.62-0.87). Further, patients not receiving IV iron or ESA were more likely to be admitted to an SNF than patients receiving both IV iron and ESA (OR = 0.44, 95% CI = 0.32-0.61), IV iron without ESA (OR = 0.57, 95% CI = 0.36-0.88), and ESA without IV iron (OR = 0.56, 95% CI = 0.47-0.67). Patients receiving neither IV iron nor ESA in the index quarter had the highest mean [SD] total Medicare reimbursement per patient in the subsequent year ($42,353 [$52,887]) compared with patients receiving IV iron without ESA ($28,654 [$32,068]), IV iron and ESA ($34,152 [$30,506]), or ESA without IV iron ($38,172 [$35,591], P = 0.001).
Use rates of IV iron and ESA in a sample of Medicare enrollees with CKD and anemia in 2006 suggest that anemia management therapies may be underutilized; however, oral iron therapy use was not measurable with the study database, and therapies initiated after the index quarter were not measured. Patients not treated with IV iron or ESA had significantly higher rates of hospitalization and SNF admission than patients treated with either IV iron or ESA. Further, mortality was significantly higher in patients receiving neither IV iron nor ESA than in patients who received IV iron and ESA. Additionally, total all-cause health care costs were higher among patients receiving neither IV iron nor ESA treatment compared with patients treated with IV iron and/or ESA.
volume sixteen • number eight
Peer-Reviewed Journal of the
Academy of Managed Care Pharmacy
Results from a Mailed Promotion of
Medication Reviews Among Department of
Defense Beneficiaries Receiving 10 or More
Outcomes of a Rheumatoid Arthritis Disease
Therapy Management Program Focusing on
Clinical and Economic Outcomes in Medicare
Beneficiaries with Stage 3 or Stage 4 Chronic
Kidney Disease and Anemia: The Role of
Intravenous Iron Therapy
Are Gastroenterologists Less Tolerant of
Treatment Risks than Patients? Benefit-Risk
Preferences in Crohn’s Disease Management
Regulatory Actions on the Off-Label Use of
Prescription Drugs: Ongoing Controversy and
Contradiction in 2009 and 2010
564 Journal of Managed Care Pharmacy JMCP October 2010 Vol. 16, No. 8 www.amcp.org
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WellPoint, Grand Island, NY
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RegenceRx/The Regence Group, Portland, OR
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Coventry Health Care, Inc., Kansas City, MO
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Prescription Solutions, Irvine, CA
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Academy of Managed Care Pharmacy,
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University of Utah, Salt Lake City, UT
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Edgar Consulting Group, Reisterstown, MD
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RegenceRx/The Regence Group, Boise, ID
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UPH Health Plans, Tucson, AZ
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C o n t e n t s
Results from a Mailed Promotion of Medication Reviews Among Department
of Defense Beneficiaries Receiving 10 or More Chronic Medications
Andrea Linton, MS; Thomas A. Bacon, PharmD, MS; Shana Trice, PharmD, BCPS;
Joshua Devine, PharmD, PhD; Linda Cottrell, BS; Thomas J. McGinnis, MGA, RPh;
and Everett B. McAllister, MPA
Outcomes of a Rheumatoid Arthritis Disease Therapy
Management Program Focusing on Medication Adherence
Karen M. Stockl, PharmD; Jennifer S. Shin, PharmD; Heidi C. Lew, PharmD; Armen Zakharyan, PhD;
Ann S. M. Harada, PhD, MPH; Brian K. Solow, MD, FAAFP; and Bradford S. Curtis, MD
Clinical and Economic Outcomes in Medicare Beneficiaries with
Stage 3 or Stage 4 Chronic Kidney Disease and Anemia: The
Role of Intravenous Iron Therapy
Tyler G. Knight, MS; Kellie Ryan, MPH; Caroline P. Schaefer, MBA;
Lynell D’Sylva, BSN, RN; and Emily D. Durden, PhD
Are Gastroenterologists Less Tolerant of Treatment Risks than Patients?
Benefit-Risk Preferences in Crohn’s Disease Management
F. Reed Johnson, PhD; A. Brett Hauber, PhD; Semra Özdemir, MS;
Corey A. Siegel, MD; Steven Hass, PhD; and Bruce E. Sands, MD
574 Cover Impressions
She’s a Keeper (2010)
Sheila Macho, Cover Editor
Regulatory Actions on the Off-Label Use of Prescription Drugs:
Ongoing Controversy and Contradiction in 2009 and 2010
Kathleen A. Fairman, MA, and Frederic R. Curtiss, PhD, RPh, CEBS
Chinese Pharmacists Propose Patient Consent for Unlabeled Use of Medications
Zhihua Zheng, PharmD, and Feng Xu, PhD
volume 16, no. 8
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J. Daniel Allen, PharmD, RegenceRx, Portland, OR
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ago. Today, they are found in Europe, Asia,
and the uplands of western North America.
Grizzlies are omnivorous, with a diet consist-
ing of grasses, roots, berries, insects, fish, and
small or large mammals, depending on the
season. In some areas, grizzly bears eat moose,
caribou, and elk, while in other areas, they eat
salmon. The bear’s coloration is usually dark
brown, and the long hairs on its shoulders and
back have white tips that give the bear a griz-
zled appearance—hence the name “grizzly.”
Amy Ringholz’s marvelous portrait of a
grizzly bear with a freshly caught salmon,
She’s a Keeper, was created using ink and oil
paint on canvas. The artist seems to capture
the essence of each animal in her semi-abstract
wildlife paintings. “Emotion, personality, and
humor are the traits I strive for in each new painting. Some of
my animals have humanlike characteristics,” she says. “You
can see their soul through their eyes. It is my hope that the
viewer will discover the similarities between our two species,
and remember to treat animals and people with kindness and
respect.” Ringholz paints wildlife because she believes that it
can give a voice to the animals of planet Earth. “It should be
our pleasure to help them and protect them. For these reasons
I moved to Jackson Hole, Wyoming, where I am closer to the
bears, bison, wolves, and bald eagles,” she says. “Spending
time watching them is one of my favorite things to do. I try
to do my part by donating artwork to several organizations
that participate in the conservation of our beautiful country
and its inhabitants.” Those organizations include the Jackson
Hole Conservation Alliance, the Earthfire Institute, Art for
Orphans, the Glacier Institute, PetSmart Charities®, and the
Art Association of Jackson Hole.
Ringholz was born in 1977 near Cleveland, Ohio to “an art-
ist father and a crafty mother,” and her life was filled with cre-
ativity as she grew up. In 1999, she received a bachelor of fine
arts degree from Bowling Green State University in Bowling
Green, Ohio. Her major was drawing, and she minored in art
education and ceramics. Ringholz’s unique art style was not
something that she planned. “My distinctive expressionistic
and cubistic styles are the result of a ‘fortuitous accident’ when
my ink began to drip on a vertically standing canvas, creating
an unpredictable effect that I have adopted into a painting tech-
nique,” she says. “I allow uncontrolled black lines to delineate
areas that I either complete with realistic detail or abstraction. I
use bold colors next to neutral ones, gestural line work, and an
element of unpredictability in order for my audience to experi-
ence the beautiful American West through my eyes.” According
to the biography on Ringholz’s website, amyringholz.com,
her friends and acquaintances attest to experiencing the fun,
rizzly bears (Ursus arctos horribilis) orig-
inated in Eurasia and traveled to North
America approximately 50,000 years
excitement, and wonder of “Amy’s world.”
Ringholz has exhibited her work in numer-
ous group and solo art shows, including the
July 2007 “W is for Wildlife” sold-out, solo
show held at the Mountain Trails Gallery in
Jackson, Wyoming. She is currently repre-
sented by 6 art galleries: the Altamira Fine
Art gallery in Jackson, Wyoming; Gallery 822
in Santa Fe, New Mexico; Austin Galleries
in Austin, Texas; Gallery MAR in Park
City, Utah; RED Contemporary gallery in
Steamboat Springs, Colorado; and the Joan
Cawley Gallery in Scottsdale, Arizona, where
She’s a Keeper is for sale.
Ringholz, who is known for her animal
portraiture, expanded her subject matter last
year to include totem-style paintings that con-
tain multiple creatures on vertical canvases.
And the artist’s work continues to evolve—
in a recent post by Tammy Christel on her
Jackson Hole Art Blog, she wrote about Ringholz’s “Resonance”
exhibit held in August 2010 at the Altamira Fine Art gallery.
“‘Resonance’ refers to Ringholz’s efforts to connect powerfully
with viewers,” she explains. “Study of textiles, 19th-Century
prints and Art Nouveau have infiltrated these compositions.
Moving into storytelling mode, these new paintings are related
to her totem series but are more illustrative—they possess a
Many articles have been written about Ringholz and her
work. She was one of several young artists featured in the
September 2005 issue of Southwest Art magazine in its “21
Under 31” article, and her Blondie painting appeared on the
cover of the September 2007 issue of the Santa Fe Circle Buyer’s
Guide. Ringholz has also won awards for her paintings, most
notably the “Gold Medal Established Artist” award in the “Best
of Jackson Hole” annual issue of JH News and Guide.
In Ringholz’s online artist statement, she writes about a
3-month sabbatical of volunteer work that she did in South
Africa in 2009: “I want to capture what I have seen and learned
and allow my animals to tell stories of tradition, dreams, sym-
bolism, and of coming together. … Africa may not be front and
center in my new work, but rather found in subtle undertones
hinting at the profound impact it has had on my life.”
Amy Ringholz, She’s a Keeper, ink and oil paint on canvas. Jackson Hole,
Wyoming. Copyright © 2010.
Interview with the artist.
C o v e r
i M P r e s s i o n s
A b o u t o u r c o v e r a r t i s t
She’s a Keeper (2010) ■ Amy Ringholz
“Emotion, personality, and
humor are the traits I strive
for in each new painting.”