Ensuring the accessibility of drugs furnished under the drug discount program

(a) In general Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended— (1) in paragraph (1)— (A) by striking that the manufacturer furnish and inserting the following: that— (A) the manufacturer furnish; (B) by striking ceiling price), and and inserting ceiling price);; (C) by striking shall require that the manufacturer offer and inserting the following: (B) the manufacturer offer; and (D) by striking the period at the end and inserting the following:, regardless of the manner or location in which the drug is dispensed; and (C) the manufacturer not place any conditions on the ability of a covered entity to purchase and use a covered outpatient drug at or below the applicable ceiling price, regardless of the manner or location in which the drug is dispensed, if such conditions— (i) would place limits on the delivery of drugs, place limits on the mechanisms through which drugs may be purchased, place limits on where such drugs may be delivered, administered, or dispensed, require a covered entity’s assurance of compliance with requirements under this section, or require the submission of claims data or other information; (ii) would not reflect customary business practices; (iii) would discourage covered entities from purchasing the manufacturer’s drugs through the drug discount program under this section or otherwise undermine the objective of this section, either by singling out covered entities from other customers for such conditions or by imposing conditions that disproportionately impact covered entities; or (iv) have not been approved in advance by the Secretary.; and (2) by adding at the end the following new paragraph: (11) Contract Pharmacies The requirements and prohibitions under paragraph (1) shall apply in the case of a covered entity that elects to contract with one or more pharmacies to dispense, to patients of the covered entity, covered outpatient drugs purchased by the covered entity at or below the applicable ceiling price described in paragraph (1).. (b) Manufacturer compliance Section 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended— (1) in paragraph (1)(B)— (A) in clause (vi), in the matter preceding subclause (I), by inserting, in the case of a manufacturer overcharging a covered entity for covered outpatient drugs after penalties; and (B) by adding at the end the following: (vii) The imposition of sanctions in the form of civil monetary penalties in the case of a violation of subsection (a)(1)(C) or (a)(11), other than an overcharge, which— (I) shall be assessed according to standards established in regulations to be promulgated by the Secretary not later than 180 days after the date of enactment; (II) shall apply to any manufacturer with an agreement under this section that intentionally violates a requirement under subsection (a)(1)(C) or (a)(11), other than an overcharge; (III) shall not exceed $2,000,000 for each day of such violation; (IV) shall be in an amount determined by the Secretary, taking into account factors such as the nature and extent of the violation and harm resulting from such violation, including, where applicable, the number of drugs affected and the number of covered entities affected; and (V) shall continue to be imposed each day until such manufacturer is no longer in violation of a requirement under subsection (a)(1)(C) or (a)(11), other than an overcharge.; and (2) in paragraph (3), by adding at the end the following: (D) Claims of violations Not later than 180 days after the date of the enactment of this subparagraph, the Secretary shall promulgate regulations to permit covered entities to assert claims of violations of subsections (a)(1) and (a)(11) under the process established under subparagraph (A)..