,,ii #aahth ,,congress #ast ,session ,s4 #bdjf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bj1 #bjbc,mr4 ,carper 7for himself and ,mr4 ,grassley7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to improve oversight of formulary development and management under ,medicare part ,d4 #a4 ,short title ,this ,act may be cited as the ,,pbm ,oversight ,act of #bjbc4 #b4 ,resolving conflicts of interest and improving oversight of ,p,t ,committee overrides 7a7 ,in general ,section #ahfj;,d-#d7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77 is amended-- 7#a7 in subparagraph 7,a77ii77,i71 by inserting the following before the semicolon3 7and1 for #bjbe and each subsequent year1 any pharmacy benefit manager72 and 7#b7 by adding at the end the following new subparagraph3 7,j7 ,reporting on additional committees with formulary decision making authority 7i7 ,in general ,for #bjbf and each subsequent plan year1 a ,,pdp sponsor shall submit to the ,secretary the following information1 if applicable1 with respect to each prescription drug plan offered by the ,,pdp sponsor3 7,i7 ,the name and a description of the role and composition of any committee1 entity1 or individual within or affiliated with the ,,pdp sponsor 7or a pharmacy benefit manager1 acting under contract with such sponsor7 that has the authority to make a coverage1 formulary placement1 or utilization management decision 7as defined in clause 7ii77,i771 other than the pharmacy and therapeutic committee described in subparagraph 7,a74 7,,ii7 ,a list of drugs for which a committee1 entity1 or individual described in subclause 7,i7 made a coverage1 formulary placement1 or utilization management decision 7as so defined7 and the corresponding initial recommendation 7as defined in clause 7ii77,,ii77 made by the pharmacy and therapeutic committee4 7,,iii7 ,a brief justification for each decision described in subclause 7,,ii74 7ii7 ,definitions ,in this subparagraph3 7,i7 ,coverage1 formulary placement1 or utilization management decision ,the term coverage1 formulary placement1 or utilization management decision means a decision by a committee1 entity1 or individual described in clause 7i77,i7 that modifies1 adjusts1 reverses1 or otherwise alters 7such as by substituting the formulary inclusion of one covered part ,d drug for another or by substituting a more general initial recommendation for a more specific decision7 an initial recommendation by the pharmacy and therapeutic committee4 7,,ii7 ,initial recommendation ,the term initial recommendation means a coverage1 formulary placement1 or utilization management decision recommended by the pharmacy and therapeutic committee prior to the review1 adoption1 or modification of such a recommendation by a committee1 entity1 or individual described in clause 7i77,i74 ,for purposes of this subparagraph1 such initial recommendation shall be considered to be separate and distinct from the final review and approval of the formulary design and components by such pharmacy and therapeutic committee1 as required under section #dbc4abj of title #db1 ,code of ,federal ,regulations 7or any successor regulation74 7iii7 ,non-application of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to information required for purposes of carrying out this subparagraph4 4 7b7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendments made by subsection 7a7 by program instruction or otherwise4 7c7 ,,gao study and report 7#a7 ,study ,the ,comptroller ,general shall conduct a study on the use of committees1 entities1 or individuals described in clause 7i77,i7 of section #ahfj;,d-#d7;b77#c77;,j7 of the ,social ,security ,act1 as added by subsection 7a71 in the development and review of formularies under part ,d of title ,,xviii of the ,social ,security ,act4 ,such study shall include an analysis of the following3 7,a7 ,the prevalence of such committees1 entities1 or individuals4 7,b7 ,the number1 type1 and characteristics of drugs for which a committee1 entity1 or individual described in such clause 7i77,i7 made a coverage1 formulary placement1 or utilization management decision 7as defined in clause 7ii77,i7 of such section #ahfj;,d-#d7;b77#c77;,j774 7,c7 ,trends in the justifications provided under clause 7i77,,iii7 of such section #ahfj;,d-#d7;b77#c77;,j74 7,d7 ,trends in the application of utilization management tools 7such as prior authorization1 step therapy1 and quantity limits7 and formulary exclusions under prescription drug plans and ,,ma-,,pd plans and the impact such tools and exclusions have on beneficiary access to covered part ,d drugs4 7#b7 ,report ,not later than ,january #a1 #bjbi1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with any recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7#c7 ,definitions ,in this subsection3 7,a7 ,comptroller ,general ,the term ,comptroller ,general means the ,comptroller ,general of the ,united ,states4 7,b7 ,other terms ,the terms covered part ,d drug1 ,,ma-,,pd plan1 and prescription drug plan have the meaning given those terms in section #ahfj;,d-#da of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea74