113 STAT. 1501A-340 PUBLIC LAW 106-113—APPENDIX F (A) in paragraph (l)(B)(ii), by striking "clause (iii)" and inserting "clause (iv)" and by striking "but"; (B) by redesignating clause (iii) of paragraph (1)(B) as clause (iv) and inserting after clause (ii) of such paragraph the following new clause: "(iii) includes implantable items described in paragraph (3), (6), or (8) of section 186l(s); but"; and (C) in paragraph (2)(B), by inserting after "resources" the following: "and so that an implantable item is classified to the group that includes the service to which the item relates". (2) CONFORMING AMENDMENT.— (A) Section 1834(a)(13) (42 U.S.C. 1395m(a)(13)) is amended by striking "1861(m)(5))" and inserting "1861(m)(5), but not including implantable items for which payment may be made under section 1833(t)". (B) Section 1834(h)(4)(B) (42 U.S.C. 1395m(h)(4)(B)) is amended by inserting before the semicolon the following: "and does not include an implantable item for which payment may be made under section 1833(t)". (f) AUTHORIZING PAYMENT WEIGHTS BASED ON MEAN HOSPITAL COSTS. —Section 1833(t)(2)(C) (42 U.S.C. 13951(t)(2)(C)) is amended by inserting "(or, at the election of the Secretary, mean)" after "median". (g) LIMITING VARIATION OF COSTS OF SERVICES CLASSIFIED WITH A GROUP.— Section 1833(t)(2) (42 U.S.C. 13951(t)(2)) is amended by adding at the end the following new flush sentence: "For purposes of subparagraph (B), items and services within a group shall not be treated as 'comparable with respect to the use of resources' if the highest median cost (or mean cost, if elected by the Secretary under subparagraph (C)) for an item or service within the group is more than 2 times greater than the lowest median cost (or mean cost, if so elected) for an item or service within the group; except that the Secretary may make exceptions in unusual cases, such as low volume items and services, but may not make such an exception in the case of a drug or biological that has been designated as an orphan drug under section 526 of the Federal Food, Drug and Cosmetic Act.", (h) ANNUAL REVIEW OF OPD PPS COMPONENTS.— (1) IN GENERAL.— Section 1833(t)(8)(A) (42 U.S.C. 13951(t)(8)(A)), as redesignated by subsection (a), is amended— (A) by striking "may periodically review" and inserting "shall review not less often than annually"; and (B) by adding at the end the following: "The Secretary shall consult with an expert outside advisory panel composed of an appropriate selection of representatives of providers to review (and advise the Secretary concerning) the clinical integrity of the groups and weights. Such panel may use data collected or developed by entities and organizations (other than the Department of Health and Human Services) in conducting such review.". (2) EFFECTIVE DATES.— The Secretary of Health and Human Services shall first conduct the annual review under the amendment made by paragraph (1)(A) in 2001 for application in 2002 and the amendment made by paragraph (1)(B) takes effect on the date of the enactment of this Act.