Irradiation reimbursement

A transfusion medicine physician in New York wishes to alert colleagues that at least one Medicare carrier is seeking to restrict reimbursement for blood product irradiation to a limited set of clinical indications that do not include, for example, patients undergoing cardiac surgery or patients with solid tumors. For details, see NGS, Inc. Draft LCD for Irradiated Blood Products (DL28533).

He is concerned because his center practices "universal irradiation" of all cellular components, largely because:

1. Most of the reported cases of GVHD are now in patients not traditionally considered immunosuppressed (a good example would be Japanese reports of patients undergoing cardiac surgery) and
2. Neither the clinical staff nor the blood bank medical staff are always aware that the patient has a immunocompromising condition at the time of initial transfusions.

He acknowledges that an argument for universal irradiation is controversial, but he feels that it is appropriate to provide these products across the board. However, this Medicare draft policy would restrict his center's ability to treat patients as they think best for them, in an area where there is certainly no definitive consensus.

He wonders how many other centers follow a similar practice. He hopes that physicians who believe this policy is unwisely restrictive and not supported by the scientific evidence communicate their opinions to the Medicare carrier at the following email address: Draft_LCD_Comments_Part_A@anthem.com

He has sent the following email:

"To whom it may concern:

This is a comment on the draft LCD for irradiated blood products (DL 28533).

I believe this policy is suboptimal. A number of major medical centers, ours included, have implemented policies of universal irradiation of all cellular blood products (i.e. all red cell, whole blood, platelet and granulocyte transfusions) to abrogate the risk of graft versus host disease (GVHD). The reason for employing this policy is that selective irradiation by diagnosis, as proposed in the policy, is bound to fail and not fully supported by the scientific literature.

Most cases of GVHD now being reported are in patients not included in the diagnostic categories listed.

Here is a review supporting my point of view from one of the most distinguished hematologist/oncologists in America, Dr. Kenneth Anderson of Harvard:

• Anderson K. Broadening the spectrum of patient groups at risk for transfusion-associated GVHD: implications for universal irradiation of cellular blood components. Transfusion. 2003 Dec;43(12):1652-4.

In Japan, universal irradiation of all cellular transfusions has been practiced for some years:

• Transfus Med. 2000 Dec;10(4):315-20. Guidelines for irradiation of blood and blood components to prevent post-transfusion graft-vs.-host disease in Japan. Asai T, Inaba S, Ohto H, Osada K, Suzuki G, Takahashi K, Tadokoro K, Minami M. Division of Blood Transfusion, Chiba University Hospital, Chiba, Japan. asaitaka@ho.chiba-u.ac.jp

The Japanese Red Cross analysed the results of questionnaires sent in 1993 regarding post-transfusion graft-vs.-host disease (PT-GVHD) from hospitals; the majority of patients with PT-GVHD in 1993 were transfused for cardiovascular or cancer surgery, and about 10 patients had died yearly from PT-GVHD in the following few years. The Japan Society of Blood Transfusion (JSBT) organized a subcommittee for the prevention of PT-GVHD, and issued a fourth version of guidelines for the irradiation of blood to prevent PT-GVHD. These guidelines recommended transfusion of irradiated blood for cardiosurgery, cancer surgery, elderly recipients and severe trauma, as well as congenital immunodeficient recipients, newborn infants and other immunocompromised patients. Also recommended was irradiation not only of blood within 72 h after collection but also of blood stored for 14 days. Reported PT-GVHD has diminished to a few cases in recent years.

Thus some institutions, such as our own, have instituted a policy of universal irradiation because:

1. Most case reports are now in patients not considered, traditionally, as "immunosuppressed" and
2. Often the clinical and blood bank physicians making decisions about the need for irradiation aren't able to diagnose that the patient has an immunosuppresive disease until after transfusions have already been given for anemia or thrombocytopenia of unknown etiology.

If the existing draft policy is implemented and institutions only irradiate blood for patients with the listed conditions, it is certain that patients will unnecessarily die of what is essentially an untreatable, albeit rare complication of transfusion, GVHD."

ADDENDA Sept. 29, 2008

1. A physician in Maine reports that he is in complete agreement with the colleague from New York. The Fiscal Intermediary in the Maine region, National Government Services, has drafted a Local Coverage Determination (LCD) restricting the use of irradiated blood products.
   
   Effective January 1, 2009, Medicare will only cover the cost of irradiation for the indications listed in the LCD. While recognizing that transfusion-associated graft versus host disease is a rare complication of transfusion, it is also clear that it occurs in patients with diagnoses other than those listed in the LCD. Leitman, et al (Transfusion 2003; 43:1667-1671) reported on a case of TA-GVHD in a 42 year old female with refractory lupus nephritis who received three monthly cycles of fludarabine. In the same issue of Transfusion, a retrospective record review of transfusions over a 10-year period at The American University of Beirut-Medical Center identified 10 cases of TA-GVHD in immunocompetent recipients receiving fresh, non-leukoreduced, non-irradiated blood.
   
   Clearly there are multiple arguments for and against universal irradiation. However, the Maine physician believe that the decision to irradiate blood components for patients other than those listed in the LCD, or even to implement irradiation of all components in an institution, as they have done in their hospital, properly belongs with each hospital’s transfusion committee rather than as an administrative decision by CMS.

2. The Medical Director of a transfusion service in the South writes "For those practicing universal irradiation of blood products, what approaches are used to offset the link/charge to patients in the computer system when there is no physician order?" He points out that one option might be to retroactively remove the link when there is no order.

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

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

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