117 STAT. 2244
Applicability.
Definition.
VerDate 11-MAY-2000
13:59 Aug 30, 2004
PUBLIC LAW 108–173—DEC. 8, 2003
reporting of the manufacturer’s average sales price for a drug or biological, the Secretary may apply a civil money penalty in an amount of up to $10,000 for each such price misrepresentation and for each day in which such price misrepresentation was applied. ‘‘(B) PROCEDURES.—The provisions of section 1128A (other than subsections (a) and (b)) shall apply to civil money penalties under subparagraph (B) in the same manner as they apply to a penalty or proceeding under section 1128A(a). ‘‘(5) WIDELY AVAILABLE MARKET PRICE.— ‘‘(A) IN GENERAL.—In this subsection, the term ‘widely available market price’ means the price that a prudent physician or supplier would pay for the drug or biological. In determining such price, the Inspector General shall take into account the discounts, rebates, and other price concessions routinely made available to such prudent physicians or suppliers for such drugs or biologicals. ‘‘(B) CONSIDERATIONS.—In determining the price under subparagraph (A), the Inspector General shall consider information from one or more of the following sources: ‘‘(i) Manufacturers. ‘‘(ii) Wholesalers. ‘‘(iii) Distributors. ‘‘(iv) Physician supply houses. ‘‘(v) Specialty pharmacies. ‘‘(vi) Group purchasing arrangements. ‘‘(vii) Surveys of physicians. ‘‘(viii) Surveys of suppliers. ‘‘(ix) Information on such market prices from insurers. ‘‘(x) Information on such market prices from private health plans. ‘‘(e) AUTHORITY TO USE ALTERNATIVE PAYMENT IN RESPONSE TO PUBLIC HEALTH EMERGENCY.—In the case of a public health emergency under section 319 of the Public Health Service Act in which there is a documented inability to access drugs and biologicals, and a concomitant increase in the price, of a drug or biological which is not reflected in the manufacturer’s average sales price for one or more quarters, the Secretary may use the wholesale acquisition cost (or other reasonable measure of drug or biological price) instead of the manufacturer’s average sales price for such quarters and for subsequent quarters until the price and availability of the drug or biological has stabilized and is substantially reflected in the applicable manufacturer’s average sales price. ‘‘(f) QUARTERLY REPORT ON AVERAGE SALES PRICE.—For requirements for reporting the manufacturer’s average sales price (and, if required to make payment, the manufacturer’s wholesale acquisition cost) for the drug or biological under this section, see section 1927(b)(3). ‘‘(g) JUDICIAL REVIEW.—There shall be no administrative or judicial review under section 1869, section 1878, or otherwise, of— ‘‘(1) determinations of payment amounts under this section, including the assignment of National Drug Codes to billing and payment codes;
Jkt 019194
PO 00000
Frm 00180
Fmt 6580
Sfmt 6581
D:\STATUTES\2003\19194PT3.001
APPS10
PsN: 19194PT3
�
