; and (B) shall pay to such nonparticipating provider the amount by which the recognized amount for such item or service exceeds the cost-sharing amount for such item or service (as determined in accordance with subparagraph (A)). ; and (C) by adding at the end the following new subsection: (i) Other definitions (1) Nonparticipating provider; participating provider; recognized amount For purposes of this section, the terms nonparticipating provider , participating provider , and recognized amount have the meaning given such terms in section 2799A–1(a)(3). (2) Rare pediatric disease The term rare pediatric disease has the meaning given such term in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. . (2) Amendment relating to definition of routine patient costs Section 2709(a)(2)(A) of the Public Health Service Act ( 42 U.S.C. 300gg–8(a)(2)(A) ) is amended— (A) by striking include all items and services and inserting include— (i) all items and services ; and (B) by striking the period at the end and inserting ; and (ii) consultation and referral services relating to approved clinical trials furnished to qualified individuals. . (3) Amendment relating to definition of approved clinical trial Section 2709(d)(1)(A) of the Public Health Service Act ( 42 U.S.C. 300gg–8(d)(1)(A) ) is amended by adding at the end the following new clause: (viii) The Patient-Centered Outcomes Research Institute. . (4) Technical and conforming amendments Section 2709 of the Public Health Service Act ( 42 U.S.C. 300gg–8 ), as amended by the preceding paragraphs, is further amended— (A) in subsection (a)— (i) in paragraph (1)(A), by inserting before clinical trial referred to in subsection (b)(2) the following: approved ; (ii) in paragraph (2)(A), by striking a clinical trial and inserting an approved clinical trial ; (iii) in paragraph (3)— (I) by striking in-network providers and inserting participating providers ; and (II) by striking a clinical trial and inserting an approved clinical trial