A physician in Maine (Dr. Irwin Gross - www.emh.org - attribution used with permission) reports that he recently submitted a request to their regional Medicare Part A Medical Director to consider amending the Medicare reimbursement policy for pre-operative use of erythropoietin to optimize hemoglobin prior to elective surgery. A generic copy of the request is attached. According to Dr. Gross, current Medicare policy allows reimbursement for orthopedic patients (a labeled use of Epogen® in "elective noncardiac, nonvascular surgery" - see page 4 of attached Epogen® product information), but, like the product information, excludes elective cardiovascular surgical patients. Dr. Gross believes that accumulating evidence suggests that avoidance of allogeneic transfusion in cardiac surgery improves outcomes, and that optimization of pre-operative hemoglobin levels decreases the probability of transfusion. Therefore, he is of the opinion that it would be reasonable to reimburse for pre-operative use of erythropoietin in patients with hemoglobin between 10 and 13 gm/dl, especially since the use of erythropoietin for such patients is a protocol followed by a number of centers with blood management and conservation programs. On the other hand, he cites information from the Epogen® (pp. 9,11), Procrit® (pp. 11,21), and Aranesp® (pp. 5,15) product information, citing possible increased risk of cardiovascular events with erythropoietic therapies as a possible reason not to approve the requested change.

The inquiring colleague would like to know if preoperative erythropoietin in cardiovascular surgery is approved for Medicare reimbursement outside northern New England? He wonders if colleagues can share data on risks of thrombosis with short term pre-operative use of erythropoietin and or darbopoietin, when the drug is given to optimize hemoglobin levels prior to surgery.

ADDENDA Jan. 15, 2007

1. Dr. Irwin Gross (attribution used with permission), who initiated this discussion, has received a reply from a Medicare Part A Medical Director of the National Government Services. With the permission of Dr. Gross, the content of the letter is provided.

2. Dr. Aryeh Shander at Englewood Hospital in New Jersey agrees with Dr. Gross in that many blood conservation centers are using off label EPO for many elective and urgent cardiac surgery patients with Acute Coronary Disease. In Dr. Shander's experience, he reports that over the last 4-5 years they have used EPO routinely as part of a protocol for more than 1,000 patients at his hospital. He reports having found the use of this medication for treatment of anemia in those patients to be safe and effective. He also reports that short term therapy has not increased these patients' risk for acute coronary syndrome or thromboembolic disease. While payment for this agent is restricted to FDA indications across the US at this point, he is hoping that this will change in the near future.

ADDENDA Jan. 26, 2007

3. Dr. Richard K. Spence, Senior Vice President for Clinical Affairs of Infonale (attribution used with permission) reports that he is supportive for the outpatient, pre-operative correction of anemia prior to cardiovascular surgery. He comments that in his experience, anemia is a risk factor or co-morbidity that affects outcomes in surgical patients. The connection between preoperative anemia, transfusion and outcomes, however, is not as widely appreciated. Anemia leads to transfusion, since hemoglobin level remains a strong "trigger." Dr. Spence comments on a data set collected by Infonale that includes a study population of 64,389 patients. In that group, 2040/6901 anemic patients were transfused (29.6%) compared to 3883/57,488 non-anemic patients (6.8%) [proprietary data]. Anemic patients received a mean of 1.24 units of RBCs; non-anemic patients received 0.4 units. Dr. Spence makes reference to studies that suggest transfusion of allogeneic blood leads to increased risk of post-operative complications, in particular post-operative infections. Studies of a variety of surgical patients have shown that correction of anemia by alternative means, including EPO and iron, reduces transfusion exposure and decreases risk. So, he believes "it stands to reason that this risk-benefit relationship should be true for cardiac surgery patients".

Furthermore, he comments: "If we want to change the reimbursement status for EPO, we must document that the presumed risk of EPO in cardiac surgery patients is at least LESS of a risk than that posed by allogeneic blood. Defining the relative risk of thrombosis caused by EPO in cardiac surgery patients is a tricky business. We cannot extrapolate simply from existing study data in other patients. Renal failure and chemotherapy patients have complex clotting abnormalities. Joint replacement patients have higher than average risk of thrombotic events because of the type of surgery. Moreover, cardiac surgery patients treated on heart-lung bypass are subjected to a roller coaster ride through the thrombotic and lytic pathways that must be taken into account. Readers should understand that only Procrit® (Ortho Biotech, NJ) is approved for preoperative correction of anemia in surgical patients. Packaging information includes two indications: orthopedic joint replacement surgery in non-cardiac and non-vascular patients, and for reduction of transfusion for ANY surgery with an anticipated blood loss that would normally lead to transfusion. Most CMS intermediaries have excluded cardiac surgery from this latter group. So, any use of Procrit® in these patients is off-label."

ADDENDA Oct. 6, 2007

4.Dr. Irwin Gross, the Medical Director of Transfusion Services at Eastern Maine Medical Center (attribution used with permission), wishes to update the e-Network Forum by reporting that last May, CMS published a National Coverage Determination (NCD) that restricted the use of erythropoietic stimulating agents ESA) in hematology and oncology patients. This NCD permits the use of ESA (epoetin alfa only) for perisurgical adjuvant therapy, with the exception of cardiac and vascular surgical patients. A Local Coverage Decision [LCD ID Number L25211], would in the opinion of Dr. Gross, would further restrict the use of ESA for perisurgical adjuvant therapy for those states that contract with National Government Services , Inc. including Indiana, Illinois, New York, New Jersey, California, much of New England, Michigan, Ohio, Kentucky, and Wisconsin. This LCD, that becomes effective December 1, 2007, restricts the perisurgical adjuvant use of epoetin alfa to patients who are undergoing hip or knee surgery; have an anemia with a hemoglobin between 10 and 13 gm/dl; are not candidates for autologous blood transfusion; and are expected to lose two units of blood. All other surgical procedures are excluded.

Further, the use of ESA for patients with anemia of chronic disease will be restricted to anemia with hemoglobin less than 10 gm/dL at the initiation of therapy, and only those patients with rheumatoid arthritis, Crohn's disease, ulcerative colitis, and hepatitis C. As stated, "until further publications show clear benefit, ESA's for anemia of other chronic diseases other than those listed above will not be covered". In his opinion this LCD, as it is being interpreted by the fiscal intermediary will have a profound inhibitory effect on preoperative anemia management and hemoglobin optimization programs in these regions. Even if hospitals are capable of absorbing the costs of ESA administration, Medicare rules require that patients sign an Advance Beneficiary Notice whereby the patient agrees to assume the financial liability for uncovered services. Most patients will choose not to sign an ABN for an expensive therapy such as ESA administration.

Dr. Gross would like to know if colleagues in the geographic areas listed above are aware of this new LCD for Erythropoietin Stimulating Agents (ESA) (L25211)? He also would like to know if any physicians and hospitals in the affected states are working with their carrier or fiscal intermediary in an effort to mitigate the expected effect this new LCD will have on pre-operative anemia management programs? Finally, he wonders if there is interest in a coordinated efforts to inform the contractor (National Government Services, Inc.) of the expected negative effect this will have on blood management and conservation efforts?

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator