Navigation Links
Oncologists Call For Medicare to Reconsider Anemia Drug Restrictions
Date:11/9/2007

WASHINGTON, Nov. 9 /PRNewswire-USNewswire/ -- The Community Oncology Alliance (COA), representing community cancer centers nationwide, formally requested that the Centers for Medicare & Medicaid Services (CMS) reconsider its decision to restrict the access of senior cancer patients to vital anemia-fighting drugs. Effective July 30, 2007, CMS implemented a National Coverage Determination (NCD) limiting oncologists' use of anemia-fighting drugs, referred to as Erythopoiesis Stimulating Agents (ESAs) in Medicare cancer patients undergoing chemotherapy treatment. Anemia is a common side effect of chemotherapy, and ESAs are used to minimize the need for red blood cell transfusions.

According to Dr. Patrick Cobb, a practicing oncologist from Billings, Montana, and Chairman of the COA Clinical Practices Committee, "What prompted this recent request to CMS to reconsider its decision to restrict ESA use was the release on November 8, 2007 of revised FDA-approved labeling for ESAs." Dr. Cobb added, "Unfortunately, what FDA considers safe and effective ESA use, CMS does not. As a result, our Medicare patients are not receiving the same standard of care as our younger patients."

The ESA labeling revisions include additional warnings related to risks associated with the use of ESAs "when dosed to target a hemoglobin of >= 12 g/dL" and instructs physicians to "use the lowest dose needed to avoid red blood cell transfusions" in order to minimize risk. However, the FDA specifically notes in both the revised label and its accompanying press release dated November 8, 2007 that, "no clinical data is available" to establish the risk of using ESAs when hemoglobin levels are less than 12 g/dL. The CMS NCD, on the other hand, arbitrarily prohibits ESA use when hemoglobin levels are 10 g/dL or higher.

"We use ESAs to reduce the need to give our patients transfusions, so we don't expose them to undue risks," said Dr. Cobb. "ESAs are important drugs, as are all the therapies we use to treat our patients--patient safety is always our primary concern. However, what CMS has done is to actually limit our ability to use ESAs in a way that minimizes transfusions."

In its reconsideration letter to CMS, COA notes, "It is readily apparent the CMS NCD essentially overrules the FDA scientific expertise by deeming ESAs unsafe and ineffective when used in the range of >=10 g/dL and <12 g/dL. Equally distressing is the fact that CMS is using a reimbursement policy to substitute its own clinical judgment, rather than allowing physicians to exercise their own clinical judgment for each individual patient's circumstances, as recommended in the newly revised FDA-approved label." COA further notes, "there is evidence to suggest that initiating ESA treatment at a hemoglobin level >10 g/dL significantly reduces the risk of transfusion."

COA is asking CMS for immediate reconsideration of the portions of the NCD dealing with cancer patients undergoing chemotherapy.

For additional information contact Ted Okon, COA Executive Director, taokon@sosacorn.com, 203-715-0300.

The Community Oncology Alliance (COA) is a non-profit organization. The mission of COA is to foster and protect the community oncology delivery system in the United States through public policy, advocacy, and education. Eighty-four percent of Americans battling cancer receive high quality, affordable, and accessible cancer care in community oncology clinics close to home. The accessibility of high quality cancer care, coupled with earlier diagnosis and new therapies, has resulted in a decreased cancer mortality rate.


'/>"/>
SOURCE Community Oncology Alliance
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Local Medicare Contractors Expand Hypertension Coverage for CardioDynamics BioZ(R) ICG Technology
2. Medicare Contractor Establishes Reimbursement Coding Guidance for Monograms Trofile Assay
3. Biopure Seeks Compassionate Use Protocol for Treatment of Acute Anemia
4. ASCO and ASH Release Updated Guideline on the Use of Chemotherapy-Related Anemia Treatments in Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/7/2017)... IRVING, Texas , Sept. 7, 2017 /PRNewswire/ ... molecular science focused on fulfilling the promise of ... that further validate the benefits of its molecular ... Each study utilized comprehensive genomic profiling plus (CGP+) ... each individual patient,s tumor on a molecular level, ...
(Date:9/7/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a ... will be participating in the Morgan Stanley 15 th ... hotel in New York.  Zimmer Biomet will present on ... A live webcast of the presentation can ... http://investor.zimmerbiomet.com .   ...
(Date:9/6/2017)... 2017  Robert G. Szewc, M.D., is recognized by ... recognition of his contributions to the Medical field.      ... at the practice of Kidney and Hypertension Specialists, which ... hypertension solutions. He has worked in this position since ... as well as expertise in kidneys, hypertension, chronic disease ...
Breaking Medicine Technology:
(Date:9/20/2017)... ... , ... “The Trials I Face to Receive God’s Grace”: a mesmerizing ... and goals to better one’s life through God. “The Trials I Face to Receive ... the wrong places, found a love for writing. Green feels that expressing his feelings ...
(Date:9/20/2017)... (PRWEB) , ... September 20, 2017 , ... ... asked at a gathering of executive marketers this week about the value of ... , "Everything that has happened in business has brought us to the ...
(Date:9/20/2017)... ... ... “They Sang At Her Funeral”: a tale of murder that will bring a church ... “They Sang At Her Funeral” is the creation of published author, Annalise Harold, an ... and twelve grandchildren. Before becoming a writer, Annalise had the opportunity to relocate often ...
(Date:9/19/2017)... ... September 19, 2017 , ... DeSola Group, a leading ... Denise Flannery, to its strategic advisory and client development team. , In ... with clients across different industries to develop and implement market-justified strategies, modernize and ...
(Date:9/19/2017)... , ... September 19, 2017 ... ... that Scott McFarland has joined its executive team as the President of ... innovative value-based care management systems and contact centers. , “Scott is a ...
Breaking Medicine News(10 mins):