CMS Pub. 100-02, ch. 15, § 50.5.5

Section 1861(s)(2)(I) of the Act provides Medicare coverage of blood clotting factors for hemophilia

patients competent to use such factors to control bleeding without medical supervision, and items related to

the administration of such factors. Therapies that enable the body to produce clotting factor and do not

directly integrate into the coagulation cascade are not themselves clotting factors. Hemophilia, a blood

disorder characterized by prolonged coagulation time, is caused by deficiency of a factor in plasma

necessary for blood to clot. For purposes of Medicare Part B coverage, hemophilia encompasses the

following conditions:

• Factor VIII deficiency (classic hemophilia);

• Factor IX deficiency (also termed plasma thromboplastin component (PTC) or Christmas factor

deficiency); and

• Von Willebrand’s disease.

Claims for blood clotting factors for hemophilia patients with these diagnoses may be covered if the patient

is competent to use such factors without medical supervision.

The amount of clotting factors determined to be necessary to have on hand and thus covered under this

provision is based on the historical utilization pattern or profile developed by the contractor for each patient.

It is expected that the treating source, e.g., a family physician or comprehensive hemophilia diagnostic and

treatment center, have such information. From this data, the contractor is able to anticipate and make

reasonable projections concerning the quantity of clotting factors the patient will need over a specific period

of time. Unanticipated occurrences involving extraordinary events, such as automobile accidents or

inpatient hospital stays, will change this base line data and should be appropriately considered. In addition,

changes in a patient’s medical needs over a period of time require adjustments in the profile.