June 25, 2013
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8011
Baltimore, MD 21244-1850
Re: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System for Proposed Fiscal Year 2014 Rates (CMS-1599-P)
Dear Ms. Tavenner:
AABB appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed rule updating the Medicare hospital inpatient prospective payment system (PPS) for fiscal year 2014. AABB (formerly known as the American Association of Blood Banks) is a professional association dedicated to advancing transfusion medicine and cellular therapies. AABB’s members include approximately 1,800 institutions, including hospital-based blood banks and laboratories, transfusion services and blood and bone marrow collection facilities, as well as approximately 8,000 individuals involved in blood, bone marrow, cord blood and peripheral blood stem cell collection, processing, storage and infusion.
Specifically, AABB would like to comment on the request for a new technology add-on payment for Kcentra. Kcentra is an important new replacement therapy for fresh frozen plasma (FFP) for patients with an acquired coagulation factor deficiency due to warfarin and who are experiencing a severe bleed. AABB believes that Kcentra meets the requirements for a new technology and therefore should receive an add-on payment.
Kcentra is a valuable new product that acts in a new, significantly more rapid way to provide substantial improvement over existing treatment options. In comparison to FFP, Kcentra is a concentrate of warfarin-dependent coagulation factors, plus natural anticoagulants. In addition, it does not contain the full range of proteins and other molecules found in FFP. Thus it is a more targeted therapy than FFP. In comparison to vitamin K therapy, Kcentra provides pre-formed factors. Vitamin K requires new factor synthesis/modification after substantial delay.
Acting as a more targeted therapy, Kcentra provides higher levels of the relevant coagulation factors in recipient plasma at a faster rate, with more rapid correction of the deficiencies induced by warfarin. Kcentra can be infused in minutes, while it typically takes two or more hours to infuse a therapeutic dose of plasma. This saved time is critical in treating patients in a trauma or intensive care setting, including patients requiring urgent surgical interventions.
Kcentra is intended for warfarin reversal in patients with acute major bleeds. It is well suited for that because it corrects coagulation factor deficiencies faster than either plasma or vitamin K. On the other hand, a common use of FFP and/or vitamin K (and perhaps the most common use) is prophylactic warfarin reversal prior to an invasive procedure – a setting that is typically less urgent. Therefore, Kcentra, once widely available, will likely be used in a different subset of patients than FFP and/or vitamin K.
Another critical benefit of Kcentra is that it requires a significantly lower infusion volume than FFP. Therefore, its use decreases the risk that patients will be exposed to a serious threat of transfusion – transfusion associated circulatory overload (TACO).
AABB strongly believes that Kcentra provides a significant improvement in care for patients in life-threatening circumstances and we urge CMS to provide an add-on payment for this new technology. If you have any questions or require additional information, please contact me at 301-215-6554.
Theresa L. Wiegmann, JD
Director, Public Policy