On behalf of the federally funded Virginia comprehensive hemophilia treatment centers (HTCs) at the University of Virginia, Virginia Commonwealth University, Children's Hospital of the Kings Daughters and the Children's National Hospital, we are requesting an modification to the exception for 18VAC110-20-275, section G to read:

"An exception to this requirement may be made for patients with inherited bleeding disorders¹ who may require therapy² to prevent or treat bleeding episodes³."

Our rationale for the request is the following:

1) The term "hemophilia" is sometimes restricted to just Factor VIII and Factor IX Deficiencies whereas "inherited bleeding disorders" captures other inherited factor deficiencies.

2) Most factor concentrates are not blood products.  Some newer hemophilia treatments are not factor concentrates.

3) Hemophilia medications are given in non-emergent outpatient settings, as a part of best practice.  Most hospitals do not carry factor concentrates; HTCs do not carry all of the products used by patients to meet their specialized needs. Pharmacokinetic studies in clinic are completed in clinic to monitor home therapy and prevent bleeding episodes.  Outpatient reimbursement often requires prior authorization which can delay treatment.  Teaching home therapy to patients and families in the outpatient setting ensures that policies and procedures are followed for patient safety.

Thank you for the opportunity to share our concerns.