; (2) for which the use is related to treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States; and (3) the use of which is supported by the FDA-approved label or peer-reviewed literature, including clinical guidelines, and that is not reviewed unfavorably in the compendia described in section 1927(g)(1)(B)(i)) of the Social Security Act or listed as a contraindication in the FDA-approved labeling. . (2) Effective date The amendment made by this subsection applies with respect to plan years beginning on or after the date that is 30 days after the date of the enactment of this Act.