340B Factor Programs

The 340B Factor Program is an established government program that allows qualifying HTCs to buy medications and supplies for patients with bleeding or clotting disorders at a discount, sell them through the HTC Factor Program, and reinvest the funds from these sales back into the care, support, and education of patients and families served by HTC. This program is sometimes called 340B Program, Factor Program, HTC Pharmacy, 340B Pharmacy, Factor Pharmacy, HTC Outpatient Pharmacy or a similar name. Here, we’ll just use the term “Factor Program”.

HTC Factor Programs buy and sell bleeding disorder related medications at a discounted rate. HTCs pass savings on to patients and insurance providers while also generating income to support the mission of the HTC to provide comprehensive care, support, and education for the bleeding disorder community. HTC Factor Program income is used to help stretch HTC resources to serve patients and expand services.

Factor Programs dispense medications and treatments used by patients with bleeding disorders including hemophilia, von Willebrand Disease, other factor deficiencies, and platelet disorders. Although often referred to as “Factor” Programs, these pharmacies may also provide non-factor treatments.

There are several types of health care organizations, called “covered entities,” that may be eligible for access to the 340B program (qualifying hospitals, health centers and some organizations receiving Federal Government grants). HTCs have a special designation, known as the “HM” (Comprehensive Hemophilia Treatment Centers) designation that allows for an HTC Factor Program. To establish an HTC Factor Program, organizations must be a federally supported HTC as part of the HRSA Regional Hemophilia Network and register, be enrolled in, and comply with all 340B Program requirements.

The HM Designation means HTCs are required to use funds “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” (source: House Commerce Committee’s report on the legislation which added section 340B to the Public Health Services Act (H.R. Rept.102- 384,102nd cong., 2d Sess., pt. 2, at 12 (1992)).)

Factor Program income must be spent within the HTC. Program income can be used to:

• Reduce medication costs for patients with bleeding and clotting disorders
• Support a comprehensive care team and provide services not covered by insurance. This might include nurse navigators, physical therapists, genetic counselors, social workers, psychologists, laboratory staff, pain specialists, data managers, case managers, interpreters, and/or support and administrative staff for continued care.
• Provide and coordinate mental health services for patients.
• Serve vulnerable communities and overcome barriers to care through outreach clinics, providing care for those in rural communities, creating specialty clinics, and advancing telehealth opportunities for patients with bleeding or clotting disorders.
• Support work to improve health equity.
• Improve problems of significant impact on individuals with bleeding or clotting disorders, such as joint disease, inhibitor development and access to care.

Overall, HTC Factor Program income helps HTCs cover expenses associated with patient health, education, and supportive services to improve patient care and experience for patients and families receiving care at the HTCs.

Strict oversight of all HTC Factor Programs is carried out by the Health Resources and Services Administration (HRSA) and the Office of Pharmacy Affairs (OPA). In addition, Regional Core Centers oversee the HTCs in their Region to review use of Factor Program funds and provide guidance and education to ensure HTCs are following required rules and regulations. HTCs themselves create policies, implement training, and hire staff to ensure their Factor Program operates in compliance with all regulations.

No. A key part of these programs is supporting patient choice. Participation in the HTC Factor Program is voluntary. Patients will still get the same comprehensive care even if they choose not receive their medication or treatments through their HTC’s Factor Program. In addition, your insurance company may require you to use a specific specialty pharmacy for your bleeding disorder treatments or may allow you to choose from more than one option including the HTC Factor Program.

Yes. In a 2017 survey of 4800 patients cared for at 128 HTCs across the US, 107 of those HTCs had a Factor program. Overall, 96% of 2535 HTC patients who used the HTC Factor Program were ‘always’ or ‘usually’ satisfied with their Factor Program. Satisfaction with the Factor Program was consistently high, regardless of patient diagnosis, severity, race, gender or age.

The Health Resources and Services Administration (HRSA)

• 340B Drug Pricing Program | Official web site of the U.S. Health Resources & Services Administration (hrsa.gov)

The 340b Coalition

• 340B Coalition – Home

National Hemophilia Program Coordinating Center (NHPCC) video: 340B Drug Program: Making a Difference in Patient’s Lives.

• 340B Drug Program Short | Making a Difference in Patients’ Lives – YouTube

Contact your Regional Core Center

Contact your HTC team