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340B Resources & Software Solutions Q&A | Steven Miller, 340B Health


Q. What is the 340B Drug Pricing Program?

The 340B program requires drug manufacturers to sell outpatient drugs at a discount to safety-net providers serving high numbers of low-income patients. Congress created the program to allow these providers to “stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” Savings from the program help fund free and low-cost medications as well HIV/AIDS, diabetes, cancer, dental, and primary care clinics that serve our most vulnerable citizens.


Q. Who is eligible for the 340B Program?

The 340B statute specifies a list of 16 types of “covered entities” that are eligible for drug price discounts. Safetynet providers eligible for 340B drug discounts include:

• Hospitals: Disproportionate Share Hospitals, Critical Access Hospitals, Children’s Hospitals, Cancer Hospitals, Rural Referral Centers, Sole Community Hospitals

• Clinics and Centers: Federally Qualified Health Centers (FQHCs), FQHC Look-Alikes, Ryan White HIV/AIDS Clinics, Black Lung Clinics, Hemophilia Diagnostic Treatment Centers, Family Planning Clinics, Sexually Transmitted Disease Clinics, Tuberculosis Clinics, Tribal/Urban Indian Health Centers, Native Hawaiian Health Centers


Q. What kind of drugs are covered by 340B?

All covered outpatient drugs as defined by section 1927(k) of the Social Security Act, are included under the 340B Program, such as drugs infused in an outpatient clinic for cancer or other diseases, diabetes medications used at home (insulin and pills), and most prescription drugs dispensed by a retail pharmacy.


Q. Who benefits from the 340B Program?

340B is a critical support for the nation’s healthcare safety net. Hospitals, clinics, and health centers that treat large numbers of low-income patients can use the savings from 340B to offset uncompensated care and the frequent underpayments by Medicaid and Medicare. 340B also provides support to patients through programs that include free or heavily discounted prescription drugs, medication management, transportation and translation services, vaccinations, and other forms of care.


Q. How does 340B intersect with programs like Medicare and Medicaid?

The 340B discount is the result of a national drug rebate agreement between drug manufacturers and the Secretary of the Department of Health and Human Services, in exchange for state Medicaid coverage and Medicare Part B coverage of their covered outpatient drugs. The 340B discounts mirror those required under Medicaid.


Q. What role do pharmacists play in 340B?

The 340B program is ultimately a discount on the purchase price by qualified and registered covered entities of covered outpatient drugs. Pharmacists are the gatekeepers of managing drug inventory, storage, and distribution throughout the hospitals, health centers, clinics, and other participating entities. Pharmacists and pharmacy technicians partner with other organizational stakeholders to assure program compliance integrity, such as finance, billing, IT, and compliance departments.


Q. How does the government conduct oversight of the 340B program?

The Health Resources and Services Administration (HRSA) oversees 340B. HRSA requires all covered entities to be recertified each year to assure integrity, compliance, transparency, and accountability. Providers and manufacturers are subject to audits to ensure they are in compliance with 340B program requirements. Since 2012, HRSA has conducted more than 1,000 audits of 340B providers and 16 audits of pharmaceutical manufacturers.


Q. What role does 340B Health play and who are your members?

340B Health is a membership organization of more than 1,300 public and private nonprofit hospitals and health systems in the federal 340B drug pricing program. The organization formed in 1993 to increase the affordability and accessibility of pharmaceutical and clinical care for the nation’s poor and underserved populations. 340B Health monitors, educates, and serves as an advocate on federal legislative and regulatory issues related to drug pricing and other pharmacy matters affecting safety-net providers. Our membership consists of a broad spectrum of hospitals, including academic medical centers, community hospitals, children’s hospitals, and rural facilities.


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Steven Miller, Vice President of Pharmacy Services, 340B Heatlh

Steven Miller is the Vice President of Pharmacy Services for 340B Health, a nonprofit organization of more than 1,300 hospitals and health systems participating in the federal 340B drug pricing program. In his role as Vice President of Pharmacy Services, he works closely with 340B hospitals and health systems to identify and resolve operational issues. He also provides technical assistance and develops pharmacy tools and other materials for members to facilitate program understanding and compliance.

Visit www.340bhealth.org for more information.


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