1. Short title This Act may be cited as the Providing Realistic Opportunity To Equal and Comparable Treatment for Rare Act or the PROTECT Rare Act . 2. Coverage of certain drugs used in treatment or management of rare disease or condition (a) Medicare (1) In general Section 1861(t)(2) of the Social Security Act ( 42 U.S.C. 1395x(t)(2) ) is amended— (A) in subparagraph (A), by inserting after regimen the following: , or in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States, ; and (B) in subparagraph (B)(ii)— (i) in subclause (I), by striking , or at the end and inserting a semicolon; (ii) in subclause (II), by striking the period at the end and inserting ; or ; and (iii) by adding at the end the following new subclause: (III) in the case of a drug that is used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States, such use is supported by peer-reviewed medical literature, including clinical guidelines, and is not reviewed unfavorably in the compendia described in section 1927(g)(1)(B)(i), or listed as a contraindication in the FDA-approved labeling. . (2) Medically accepted uses of covered part d drugs in treating rare conditions Section 1860D–2(e)(4)(A) of the Social Security Act ( 42 U.S.C. 1395w–102(e)(4)(A) ) is amended— (A) in clause (i)(II), by striking and ; (B) by redesignating clause (ii) as clause (iii); and (C) by inserting after clause (i)(II) the following new clause: (ii) in the case of a covered part D drug used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States, in section 1861(t)(2)(B)