Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition of “Patient”

    SUMMARY: Section 602 of Public Law 102-585, the “Veterans Health Care Act of 1992,” enacted Section 340B of the Public Health Service (PHS) Act “Limitation on Prices of Drugs Purchased by Covered Entities.” Section 340B provides that in order to obtain Medicaid reimbursement for its covered outpatient drugs, a manufacturer must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price to covered entities for outpatient drugs that will not exceed an amount determined under a statutory formula. Section 340B is administered as the “340B Drug Pricing Program” and is commonly referred to as “the 340B Program.”

    Section 340B states that it is illegal for covered entities to sell medications purchased under the 340B Program to persons who are not considered “patients” of the covered entity. The purpose of this notice is to inform interested parties of proposed clarifications to the definition of “patient” for whom the covered entity can purchase discounted pharmaceuticals under the 340B Program. This clarification is necessary to protect the integrity of the 340B Program and to assist covered entities and other participants in their compliance efforts. Link…

    DATES: The public is invited to submit comments on the proposed guidelines by March 13, 2007. After consideration of the comments submitted, the Secretary will issue final guidelines.

    ADDRESSES: Address all comments to Mr. Bradford R. Lang, Public Health Analyst, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD 20857.

    FOR FURTHER INFORMATION CONTACT: Mr. Jimmy Mitchell, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD 20857, or by telephone through the Pharmacy Services Support Center at 1-800-628-6297.