Page:United States Statutes at Large Volume 120.djvu/87

 120 STAT. 56 Deadline.

Regulations.

42 USC 1396r–8.

VerDate 14-DEC-2004

10:20 Jul 12, 2007

PUBLIC LAW 109–171—FEB. 8, 2006 (A) INSPECTOR GENERAL RECOMMENDATIONS.—Not later than June 1, 2006, the Inspector General of the Department of Health and Human Services shall— (i) review the requirements for, and manner in which, average manufacturer prices are determined under section 1927 of the Social Security Act, as amended by this section; and (ii) shall submit to the Secretary of Health and Human Services and Congress such recommendations for changes in such requirements or manner as the Inspector General determines to be appropriate. (B) DEADLINE FOR PROMULGATION.—Not later than July 1, 2007, the Secretary of Health and Human Services shall promulgate a regulation that clarifies the requirements for, and manner in which, average manufacturer prices are determined under section 1927 of the Social Security Act, taking into consideration the recommendations submitted to the Secretary in accordance with subparagraph (A)(ii). (d) EXCLUSION OF SALES AT A NOMINAL PRICE FROM DETERMINATION OF BEST PRICE.— (1) MANUFACTURER REPORTING OF SALES.—Subsection (b)(3)(A)(iii) of such section is amended by inserting before the period at the end the following: ‘‘, and, for calendar quarters beginning on or after January 1, 2007 and only with respect to the information described in subclause (III), for covered outpatient drugs’’. (2) LIMITATION ON SALES AT A NOMINAL PRICE.—Subsection (c)(1) of such section is amended by adding at the end the following new subparagraph: ‘‘(D) LIMITATION ON SALES AT A NOMINAL PRICE.— ‘‘(i) IN GENERAL.—For purposes of subparagraph (C)(ii)(III) and subsection (b)(3)(A)(iii)(III), only sales by a manufacturer of covered outpatient drugs at nominal prices to the following shall be considered to be sales at a nominal price or merely nominal in amount: ‘‘(I) A covered entity described in section 340B(a)(4) of the Public Health Service Act. ‘‘(II) An intermediate care facility for the mentally retarded. ‘‘(III) A State-owned or operated nursing facility. ‘‘(IV) Any other facility or entity that the Secretary determines is a safety net provider to which sales of such drugs at a nominal price would be appropriate based on the factors described in clause (ii). ‘‘(ii) FACTORS.—The factors described in this clause with respect to a facility or entity are the following: ‘‘(I) The type of facility or entity. ‘‘(II) The services provided by the facility or entity. ‘‘(III) The patient population served by the facility or entity.

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