The bleeding disorders community has long advocated for the creation of and funding for several federal programs that focus on research, surveillance, and treatment services provided to people with bleeding disorders.
Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau (MCHB)
Since 1974, Congress has authorized and funded hemophilia programs at the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA). NHF advocates for support of these federal hemophilia programs that provide funding for research, surveillance, prevention and services for people with bleeding disorders.
In keeping with HRSA's emphasis on patient‐centered, integrated care, HTCs serve as " specialty medical homes" for people with bleeding disorders, from childhood through end of life. HRSA recognizes the centers' role in providing comprehensive disease management and considers them a model for chronic disease care. With funding from HRSA, HTCs provide critical, comprehensive multidisciplinary services not typically covered by insurance, such as physical therapy assessments, social work and case management services.
CDC Division of Blood Disorders
The CDC Division of Blood Disorders provides funding for several programs including ones that support research, surveillance, and prevention for bleeding and clotting disorders including hemophilia. Funding also supports patient education and outreach for individuals with hemophilia and women with bleeding disorders, as well as an information clearinghouse on these disorders. CDC programs help to enhance public and scientific understanding of hemophilia and other bleeding disorders, which has resulted in the development and implementation of strategies to diagnose women with bleeding disorders and prevent co-morbidities and secondary complications from hemophilia.
CDC supports outreach and education programs provided by the national patient organizations in hemophilia and other bleeding and clotting disorders.
National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI)
NHF advocates for funding for NHLBI, which supports biomedical research in hemophilia, von Willebrand Disease and other bleeding disorders.
Recognizing the devastating consequences of a person with hemophilia developing an inhibitor (when a patient’s treatments stop working increasing the risk of bleeding, joint disease, and hospitalization), NHLBI held a State of the Science Workshop on Factor VIII Inhibitors in May 2018. The product of the workshop is a national blueprint for future basic, translational, and clinical research on the prevention and eradication of these inhibitors. NHF strongly supports furthering this area of critical research.
With support from champions on both sides of the aisle, NHF has been successful in advocating annually for funding for federal programs impacting the bleeding disorder community. In the FY 2021 funding bills enacted in December 2020, there was level funding for the federal hemophilia programs at HRSA and the CDC, and a 3% increase for the NIH overall. These funding levels align with NHF’s advocacy during Washington Days and throughout the year. The bill also included report language NHF supported indicating Congress’s support for these programs and their positive benefit on our community. NHF thanks our Congressional champions for their support of the federal hemophilia programs and all community members who participated in our advocacy this year. We will soon turn to the FY 2022 process and will continue our advocacy in these areas.
340B Drug Pricing Program
The Veterans Health Care Act of 1992 designated federally funded Hemophilia Diagnostic and Treatment Centers as covered entities eligible to participate in the 340B Drug Pricing Program. HTCs were included as covered entities to stretch their federal grant funding to provide comprehensive services to all patients served by the center. Before the passage of the Affordable Care Act, access to discounted drugs also prevented patients from exceeding their insurance plans’ lifetime and annual limits.
Today, approximately 100 of the 140 HTCs have elected to participate in the 340B program. HTCs treat a mix of patients with private and public insurance, as well as the uninsured. As a condition of their federal grant, HTCs must invest all revenues from the 340B program back into patient services, care coordination, research and other programs that directly benefit patients. In order to dispense 340B drugs to a patient, the individual must receive services at the center.
Federal funding for HTCs was flat for many years and has declined in recent years due to budget cuts and the effects of sequestration. Today, average federal funding per center is approximately $35,000, which does not cover the many uncompensated services provided by HTCs, including social work, physical therapy assessments, care coordination, and patient education. In this era of fiscal constraint, HTC participation in the 340B program has provided a critical means of financial support for HTC services and maintaining comprehensive care for all patients seen at the center.
NHF believes that the bleeding disorders community should have a choice in healthcare provider, treatments, and supplier of health care services. NHF believes that HTCs with 340B drug programs are an important option that should be available to all patients, regardless of their health insurance coverage – private or public (Medicaid, Medicare). NHF supports the HTC policy that all 340B savings from hemophilia treatments be used to support HTC services and programs that benefit all patients served by the HTC.
Depending on their healthcare coverage, consumers may have a variety of pharmacy options from which to choose, including HTC 340B pharmacy programs. NHF supports programs that include comprehensive coordinated clinical services and an integrated pharmacy program. NHF opposes any system that limits patient choice or fragments care. Moreover, NHF opposes any policies that would limit the ability of an HTC to participate in the 340B program based on the percentage of the patient population that is indigent or that would allow only uninsured patients to access 340B drugs. Due to the high cost of care and complexity of their condition, all patients served by HTCs are medically vulnerable.