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New Medicare Rule Excludes Clotting Factor

On June 27, 2005 the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule, giving physicians who treat Medicare patients the choice of opting into a new Competitive Acquisition Program (CAP). CAP will allow participating physicians, who administer certain injectable drugs covered under Medicare’s Supplemental Medical Insurance (Part B), to obtain these drugs only from specific vendors. These vendors would then bill Medicare directly.

NHF had joined with others in the bleeding disorders community and with industry to express concern to both the Secretary of Health and Human Services and CMS, about how the inclusion of clotting factor in CAP might threaten the ability of people with bleeding disorders on Medicare to access the full range of products. NHF argued that clotting factor did not meet the statutory definition of a physician-administered drug and, therefore, should be explicitly exempt from CAP.

Drugs covered under the new Medicare Part D Prescription Drug Benefit are excluded from CAP. Fortunately, self-administered treatments such as intravenous immune globulin (IVIG), immunosuppressive drugs and hemophilia clotting factor will also be excluded from the program. In short, the interim rule specifically mentions excluding hemophilia clotting factor. Any future consideration of its inclusion in the program will be subject to a proposed rule and public comment.


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