,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hdfg ,,in ,,the ,,house ,,of ,,representatives ,september #cj1 #bjbj,mr4 ,thompson of ,california 7for himself and ,mr4 ,kelly of ,pennsylvania7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend titles ,,xviii and ,,xix of the ,social ,security ,act and title ,,xxvii of the ,public ,health ,service ,act to provide for coverage of certain drugs used in the treatment or management of a rare disease or condition1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,access to ,rare ,indications ,act of #bjbj4 #b4 ,coverage of certain drugs used in treatment or management of rare disease or condition 7a7 ,medicare 7#a7 ,in general ,section #ahfa7t77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7t77#b77 is amended-- 7,a7 in subparagraph 7,a71 by inserting after regimen the following3 1 or in the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states12 and 7,b7 in subparagraph 7,b77ii7-- 7i7 in subclause 7,i71 by striking 1 or at the end and inserting a semicolon2 7ii7 in subclause 7,,ii71 by striking the period at the end and inserting 2 or2 and 7iii7 by adding at the end the following new subclause3 7,,iii7 in the case that the drug is used in the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states1 such use is supported by peer-reviewed literature1 clinical guidelines1 or expert opinion within the ,national ,institutes of ,health ,rare ,diseases ,clinical ,research ,network consortia or its participating clinical centers4 4 7#b7 ,prohibition of coverage exclusions for formularies under ,medicare part ,d ,section #ahfj;,d-#d7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77 is amended by adding at the end the following new subparagraph3 7,i7 ,prohibition of certain coverage exclusions 7i7 ,in general ,if the ,,pdp sponsor of a prescription drug plan uses a formulary1 such sponsor may not impose a limitation or exclusion of benefits with respect to coverage of a rare disease covered part ,d drug 7as defined in clause 7ii77 included in such formulary4 7ii7 ,rare disease covered part ,d drug ,for purposes of this subparagraph1 the term rare disease covered part ,d drug means a covered part ,d drug-- 7,i7 used in the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states2 and 7,,ii7 the use of which is supported by peer-reviewed literature1 clinical guidelines1 or expert opinion within the ,national ,institutes of ,health ,rare ,diseases ,clinical ,research ,network consortia or its participating clinical centers4 4 7#c7 ,effective date ,the amendments made by this subsection apply with respect to items and services furnished on or after the date that is #cj days after the date of the enactment of this ,act4 7b7 ,medicaid 7#a7 ,in general ,section #aibg7k77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#f77 is amended-- 7,a7 by striking 1 or and inserting a comma2 and 7,b7 by inserting before the period the following3 1 or the use of which is related to the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states and is supported by peer-reviewed literature1 clinical guidelines1 or expert opinion within the ,national ,institutes of ,health ,rare ,diseases ,clinical ,research ,network consortia or its participating clinical centers4 7#b7 ,prohibition of coverage exclusions for formularies ,section #aibg7;d77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;d77#d77 is amended-- 7,a7 in subparagraph 7,c71 by striking ,a covered outpatient drug and inserting ,subject to subparagraph 7,e71 a covered outpatient drug2 7,b7 by redesignating subparagraph 7,e7 as subparagraph 7,f72 and 7,c7 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,notwithstanding subparagraph 7,c71 the ,state may not impose a limitation or exclusion of benefits with respect to coverage of a covered outpatient drug that is-- 7i7 used in the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states2 and 7ii7 the use of which is supported by peer-reviewed literature1 clinical guidelines1 or expert opinion within the ,national ,institutes of ,health ,rare ,diseases ,clinical ,research ,network consortia or its participating clinical centers4 4 7#c7 ,effective date ,the amendments made by this subsection apply with respect to covered outpatient drugs furnished on or after the date that is #cj days after the date of the enactment of this ,act4 7c7 ,private health insurance 7#a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following new section3 #bgcj4 ,coverage of certain drugs used in treatment or management of rare disease or condition 7a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide coverage for a drug-- 7#a7 approved by the ,food and ,drug ,administration2 7#b7 used in the treatment or management of a disease or condition affecting #bjj1jjj or fewer individuals in the ,united ,states2 and 7#c7 the use of which is supported by peer-reviewed literature1 clinical guidelines1 or expert opinion within the ,national ,institutes of ,health ,rare ,diseases ,clinical ,research ,network consortia or its participating clinical centers4 7b7 ,prohibition of certain coverage exclusions ,a group health plan or a health insurance issuer offering group or individual health insurance coverage may not impose a limitation or exclusion of benefits with respect to coverage of a drug described in subsection 7a7 other than a limitation or exclusion of benefits with respect to a use of such drug identified as contraindicated by the ,food and ,drug ,administration4 4 7#b7 ,effective date ,the amendment made by this subsection applies with respect to plan years beginning on or after the date that is #cj days after the date of the enactment of this ,act4