,,ib ,union ,calendar ,no4 #fbh #aahth ,,congress #b;d ,session ,h4 ,r4 #cbij ,report ,no4 #aah-geg ,,in ,,the ,,house ,,of ,,representatives ,may #ae1 #bjbc,mr4 ,bucshon introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,november #bj1 #bjbd,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed,strike out all after the enacting clause and insert the part printed in italic,for text of introduced bill1 see copy of bill as introduced on ,may #ae1 #bjbc ,a ,,bill ,to amend title ,,iii of the ,public ,health ,service ,act to ensure transparency and oversight of the #cdj;,b drug discount program4 #a4 ,short title ,this ,act may be cited as the #cdj;,b ,transparency ,act4 #b4 ,ensuring transparency and oversight of the #cdj;,b drug discount program 7a7 ,in general ,section #cdj;,b7a77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7a77#e77 is amended-- 7#a7 in subparagraph 7,c7-- 7,a7 by striking ,a covered entity shall permit and inserting3 7i7 ,duplicate discounts and drug resale ,a covered entity shall permit 2 and 7,b7 by adding at the end the following new clauses3 7ii7 ,use of savings ,a covered entity shall permit the ,secretary to audit1 at the ,secretary's expense1 the records of the entity to determine-- 7,i7 how savings 7as defined in subparagraph 7,e77iv77 from covered outpatient drugs subject to an agreement under this section furnished by such entity are used by such entity2 and 7,,ii7 such entity's compliance with subparagraph 7,e74 7iii7 ,records retention ,covered entities shall retain such records and provide such records and reports as determined necessary by the ,secretary for carrying out this subparagraph4 2 and 7#b7 by adding at the end the following new subparagraph3 7,e7 ,reporting 7i7 ,in general ,during the first year beginning on or after the date that is #ad months after the date of enactment of this subparagraph and during each subsequent year1 each covered entity described in subparagraph 7,l7 of paragraph 7#d7 7and any other covered entity specified by the ,secretary7 shall report to the ,secretary 7at a time and in a form and manner specified by the ,secretary7 the following information with respect to the preceding year3 7,i7 ,with respect to such covered entity and each off-campus outpatient department1 as applicable1 of such entity-- 7aa7 the total number of individuals who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section2 and 7bb7 the number of such individuals described in a category specified in clause 7iv71 broken down by each such category4 7,,ii7 ,with respect to such covered entity and each off-campus outpatient department1 as applicable1 of such entity-- 7aa7 the percentage of the total number of individuals furnished items and services during such preceding year who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section2 and 7bb7 for each category specified in clause 7iii71 the percentage of the total number of individuals described in such category furnished items and services during such preceding year who were dispensed or administered covered outpatient drugs during such preceding year that were subject to an agreement under this section4 7,,iii7 ,with respect to such covered entity and each off-campus outpatient department1 as applicable1 of such entity1 the total costs incurred during the year at each such site and the cost incurred at each such site for charity care 7as defined in line #bc of worksheet ,s-#aj to the ,medicare cost report1 or in any successor form74 7,,iv7 ,with respect to such covered entity and each off-campus outpatient department1 as applicable1 of such entity1 the costs incurred during the year of furnishing items and services at each such department to patients of such entity who were entitled to benefits under part ,a of title ,,xviii of the ,social ,security ,act or enrolled under part ,b of such title1 enrolled in a ,state plan under title ,,xix of such ,act 7or a waiver of such plan71 or who were uninsured for services1 minus the sum of-- 7aa7 payments under title ,,xviii of such ,act for such items and services 7including any cost sharing for such items and services72 7bb7 payments under title ,,xix of such ,act for such items and services 7including any cost sharing for such items and services72 and 7cc7 payments by uninsured patients for such items and services4 7,v7 ,with respect to such covered entity and each off-campus outpatient department1 as applicable1 of such entity1 savings 7as defined in clause 7iv77 from covered outpatient drugs subject to an agreement under this section furnished by such entity or department4 7ii7 ,publication ,the ,secretary shall publish data reported under clause 7i7 with respect to a year annually on the public website of the ,department of ,health and ,human ,services in an electronic and searchable format1 which may include the #cdj;,b ,office of ,pharmacy ,affairs ,information ,system 7or a successor to such system71 in a manner that shows each category of data reported in the aggregate and identified by the specific covered entity submitting such data4 ,the ,secretary shall include in such publication the disproportionate patient percentage 7as defined in section #ahhf7;d77#e77;,f77vi7 of the ,social ,security ,act7 of each such covered entity 7if applicable7 for each cost reporting period occurring during such year4 7iii7 ,categories specified ,for purposes of clause 7i71 the categories specified in this clause are the following3 7,i7 ,individuals covered under a group health plan or group or individual health insurance coverage 7as such terms are defined in section #bgia74 7,,ii7 ,individuals entitled to benefits under part ,a or enrolled under part ,b of title ,,xviii of the ,social ,security ,act4 7,,iii7 ,individuals enrolled under a ,state plan under title ,,xix of such ,act 7or a waiver of such plan74 7,,iv7 ,individuals enrolled under a ,state child health plan under title ,,xxi of such ,act 7or a waiver of such plan74 7,v7 ,individuals not described in any preceding subclause and not covered under any ,federal health care program 7as defined in section #aabh;,b of such ,act but including the program established under chapter #hi of title #e1 ,united ,states ,code74 7iv7 ,definitions ,for purposes of this subparagraph3 7,i7 ,off-campus outpatient department ,the term off-campus outpatient department means a department of a provider 7as defined in section #dac4fe of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 that is not located-- 7aa7 on the campus 7as defined in such section7 of such provider2 or 7bb7 within the distance 7described in such definition of campus7 from a remote location of a hospital facility 7as defined in such section74 7,,ii7 ,savings ,the term savings means1 with respect to a covered outpatient drug purchased by a covered entity1 the difference between-- 7aa7 the price for such drug that such entity would have otherwise paid for such drug obtained through a group purchasing organization or other group purchasing arrangement had the requirement described in paragraph 7#d77,l77iii7 not applied 7or1 in the case such entity would not have obtained covered outpatient drugs through such an organization or arrangement had such requirement not applied or information to determine such price that such entity would have so otherwise paid is not available1 the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act7 for such drug72 and 7bb7 the ceiling price for such drug4 4 7b7 ,enforcement ,section #cdj;,b7d77#b77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b7d77#b77;,b77 is amended by adding at the end the following new clause3 7vi7 ,the imposition of civil monetary penalties in amounts determined appropriate by the ,secretary in the case that the ,secretary determines that a covered entity is not in compliance with subsection 7a77#e77;,e7 4 4 7c7 ,rulemaking ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue an interim final rule to carry out section #cdj;,b7a77#e77;,e7 of the ,public ,health ,service ,act1 as added by subsection 7a77#b74 ,november #bj1 #bjbd,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed