As you may be aware, ASH was successful in removing any limitation on erythropoiesis-stimulating agent (ESA) treatment for anemia in patients with myelodysplastic syndromes (MDS) from Medicare's National Coverage Decision (NCD) on ESAs in cancer. Unfortunately, CMS directed that ESA coverage for MDS patients be handled on the local level and several Medicare carriers and Medicare Administrative Contractors (MACs) are in the process of revising their ESA coverage limitations for MDS patients. Also, some of these local policies reflect the limitations that are included in the NCD.
To assist its members on the local level, ASH, working with a task force with expertise in MDS, developed a model policy on coverage for ESA treatment of anemia for patients with MDS. It is written in a format used for local coverage decisions (LCDs). We encourage you to submit this document along with a personal letter to your carrier if your local policy is being revised and is open for comment. ASH will submit the model policy formally as part of the open request for comments, but the local carriers and MACs are typically more sympathetic to local physicians.
There currently are two draft LCD policies that are open for comment until early December: Trailblazer, which will cover Delaware, Maryland, Texas, and Virginia (and likely Colorado, New Mexico and Oklahoma) and Noridian, which will cover Arizona, Montana, North Dakota, South Dakota, Utah, and Wyoming.
(Note - The revisions to ESA coverage on the local level are occurring at the same time reforms are being made to the existing carrier structure. For that reason, which states are covered by which policy is very fluid.)
Please contact Government Relations and Practice Specialist Stephanie Kart at email@example.com or 202-776-0544 if you would like to learn more about carrier reforms, including the status of the ESA coverage policy, in your state and for assistance in working with local carriers.
Indications for ESA Treatment for Patients With MDS
The following coverage criteria apply to both EPO and DPA.
is observed in 90 percent of individuals with myelodysplastic syndromes
(MDS). Those MDS patients with an endogenous EPO level of less than 500
mU/mL are more likely to respond to erythropoiesis-stimulating agent
ESA therapy. ESA therapy is indicated for patients with a confirmed
diagnosis of MDS, when the anemia is symptomatic, there is a reasonable
expectancy of longer survival and therapy is provided in order to end
or reduce the need for transfusions.
Medicare will cover either EPO or DPA for the treatment of anemia in MDS when the following criteria are met:
- Patient with anemia associated with MDS with bone marrow blast
count of less than 10 percent blasts (238.72, 238.73, 238.74, and
- Patient's anemia is symptomatic
- Pretreatment Hgb level of <10 g/dL or Hct of <30 percent obtained within one week of the initial injection.
- Dose, dosage frequency, and increases:
- If no increase in Hgb of 1 g/dL or greater in first month, increase
dose to 60,000 units of EPO or proportionate increase in DPA dosage to
- If no increase in Hgb of 1 g/dL or greater in second month,
increase dose to 80,000 units or a proportionate increase in DPA dosage
to 400 micrograms.
- If no increase in Hgb of 1 g/dL or greater in third month, discontinue therapy.
- Dosage should be titrated so that the Hgb is within a range of 10 - 12 g/dL or Hct of 30 - 36 percent.
- Once the patient's Hgb is >10 g/dL or Hct >30 percent,
decrease the current dose by 10 - 25 percent to maintain the target
range of 10-12 g/dL or 30-36 percent.
- After 12 weeks of EPO/DPA therapy with the appropriate dose
titrations, Hgb must increase by at least 1 g/dL or transfusion
requirement must decrease by 50 percent resulting in a rate of two
units per month or less for treatment to continue.
ESA therapy would not be covered if Hgb/Hct levels are above 12 g/dL/36 percent.
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