SECTION 355.8548. 340B Covered Entities

(a) Scope. This section applies to each manufacturer of outpatient drugs that has executed an agreement with the Secretary of the United States Department of Health and Human Services under Section 340B of the Public Health Service Act (42 U.S.C. §256b).

(b) Definitions. For purposes of this section, the following terms are defined as follows:

(1) 340B covered entity--A health-care organization enrolled in the 340B Program.

(2) 340B covered outpatient drug--A drug eligible for purchase through the 340B Program, as defined in 42 C.F.R. §10.20 and §10.21.

(3) 340B price--The maximum price that the United States Health Resources and Services Administration will allow a drug manufacturer to charge a 340B covered entity for a 340B covered outpatient drug purchased through the 340B program. The 340B price is also known as the "ceiling price."

(4) 340B program--A drug-pricing program established under Section 340B of the Public Health Service Act (42 U.S.C. §256b) under which a manufacturer of covered outpatient drugs agrees that it will not charge a 340B covered entity more than the 340B price for a 340B covered outpatient drug.

(5) HHSC--The Texas Health and Human Services Commission or its designee.

(c) Reimbursement methodology. HHSC reimburses a 340B covered entity for a 340B covered outpatient drug purchased through the 340B program and dispensed to a patient of a 340B covered entity based on HHSC's estimate of the 340B price plus a professional dispensing fee assigned by HHSC in accordance with §355.8551 of this division (relating to Professional Dispensing Fee).

Source Note: The provisions of this §355.8548 adopted to be effective November 16, 1987, 12 TexReg 3553; transferred effective September 1, 1993, as published in the Texas Register September 7, 1993, 18 TexReg 5978; transferred effective September 1, 1997, as published in the Texas Register December 11, 1998, 23 TexReg 12660; amended to be effective April 1, 2014, 39 TexReg 2062; amended to be effective May 15, 2016, 41 TexRex 3300; amended to be effective April 15, 2019, 44 TexReg 1837