Publication of fair prices

(a) In general Not later than the fair price publication date with respect to a fair price applicability year, the Secretary of Health and Human Services (in this section referred to as the Secretary) shall, with respect to each approved prescription drug, establish and publish the price that the Secretary determines to be a fair price for such drug in order for the manufacturer of such drug to provide access to such price— (1) to any fair price eligible individual who is dispensed such drug during such fair price applicability year (and to pharmacies, mail order services, and other dispensers, with respect to such individuals who are dispensed such drugs); and (2) to hospitals, physicians, and other providers of services and suppliers that furnish or administer such drug to such an individual during such year. In establishing the fair price for each such drug, the Secretary shall take into account the recommendations made by the Prescription Drug Price Regulatory Commission (in this section referred to as the Commission) under section 2(b)(1) for such drug and such year. (b) Revisions The Secretary may revise the fair price applicable to an approved prescription drug for a fair price applicability year after the fair price publication date with respect to such year has passed if— (1) the Secretary has received a recommendation from the Commission that the fair price be so revised; (2) in the judgment of the Secretary, revising such fair price is necessary to account for significant changes to— (A) supply (or projected supply) or demand (or projected demand) for such drug; or (B) any of the other factors described in section 2(b)(3) with respect to such drug; and (3) the Secretary notifies the manufacturer of such drug not less than 30 days before such revised fair price goes into effect. (c) Temporary fair price waiver (1) In general The Secretary may authorize a manufacturer of an approved prescription drug to provide access to such drug to a fair price eligible individual described in paragraph (1) of subsection (a) (or to a hospital, physician, or other provider of services or supplier described in paragraph (2) of such subsection with respect to such individual) at a price in excess of a fair price if, in the judgment of the Secretary, such authorization is necessary to maintain access to such drug for all fair price eligible individuals. (2) Duration of waiver An authorization under this subsection shall last for a period of 90 days. The Secretary may extend such authorization for 1 or more additional 90-day periods if the Secretary determines such extension is necessary. (d) Penalties for noncompliance by a manufacturer (1) In general In addition to any other penalties prescribed by law, any manufacturer of an approved prescription drug that does not provide access during a fair price applicability year to a price that is equal to or less than the fair price for such drug for such year (or, in the case that an authorization under subsection (c) is in effect with respect to such manufacturer and drug, a price that is equal to or less than the price authorized under such subsection)— (A) to a fair price eligible individual who is dispensed such drug during such fair price applicability year (and to pharmacies, mail order services, and other dispensers, with respect to such individuals who are dispensed such drugs); or (B) to a hospital, physician, or other provider of services or supplier that furnished or administered such drug to such an individual during such year; shall be subject to a civil penalty, for each year and for each drug for which the violation occurs, equal to 10 times the amount equal to the product of the number of units of such drug so furnished, dispensed, or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider of services, or supplier and the fair price for such drug for such year (or the price authorized under subsection (c), as applicable). (2) Application The provisions of section 1128A of the Social Security Act (42 U.S.C. 1320a–7) (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a).