#aafth ,,congress #b;d ,session ,h4 ,r4 #aegj ,,an ,,act ,to amend title ,,xviii of the ,social ,security ,act to waive coinsurance under ,medicare for colorectal cancer screening tests1 regardless of whether therapeutic intervention is required during the screening1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,removing ,barriers to ,colorectal ,cancer ,screening ,act of #bjbj4 #b4 ,waiving medicare coinsurance for certain colorectal cancer screening tests 7a7 ,in general ,section #ahcc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is amended-- 7#a7 in the second sentence1 by striking section #ahcd7j7 and inserting section #ahcd7o72 7#b7 by moving such second sentence #b ems to the left2 and 7#c7 by inserting the following third sentence following such second sentence3 ,for services furnished on or after ,january #a1 #bjbb1 paragraph 7#a77,y7 shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test1 or for the removal of tissue or other matter or other procedure that is furnished in connection with1 as a result of1 and in the same clinical encounter as the screening test44 7b7 ,special coinsurance rule for certain tests ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7#a7 in subsection 7a77#a77,y71 by inserting subject to subsection 7dd71 before with respect to2 and 7#b7 by adding at the end the following new subsection3 7dd7 ,special coinsurance rule for certain colorectal cancer screening tests 7#a7 ,in general ,in the case of a colorectal cancer screening test to which paragraph 7#a77,y7 of subsection 7a7 would not apply but for the third sentence of such subsection that is furnished during a year beginning on or after ,january #a1 #bjbb1 and before ,january #a1 #bjcj1 the amount paid shall be equal to the specified percent 7as defined in paragraph 7#b77 for such year of the lesser of the actual charge for the service or the amount determined under the fee schedule that applies to such test under this part 7or1 in the case such test is a covered ,,opd service 7as defined in subsection 7t77#a77;,b771 the amount determined under subsection 7t774 7#b7 ,specified percent defined ,for purposes of paragraph 7#a71 the term specified percent means-- 7,a7 for #bjbb and #bjbc1 #hj percent2 7,b7 for #bjbd and #bjbe1 #he percent2 7,c7 for #bjbf and #bjbg1 #ij percent2 and 7,d7 for #bjbh and #bjbi1 #ie percent4 4 7c7 ,conforming amendments ,paragraphs 7#b7 and 7#c7 of section #ahcd7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7d77 are each amended-- 7#a7 in subparagraph 7,c77ii71 in the matter preceding subclause 7,i71 by striking ,notwithstanding and inserting ,subject to section #ahcc7;a77#a77,y71 but notwithstanding2 and 7#b7 in subparagraph 7,d71 by striking ,if during and inserting ,subject to section #ahcc7;a77#a77,y71 if during4 #c4 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#b77;,a71 by inserting or subsection 7f77#b71 as applicable before the period at the end2 7,b7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7,c7 in paragraph 7#f77;,a71 in the matter preceding clause 7i71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7#b7 in subsection 7f7-- 7,a7 by striking ,for requirements and inserting the following3 7#a7 ,in general ,for requirements 2 and 7,b7 by adding at the end the following new paragraph3 7#b7 ,manufacturers without a rebate agreement under title ,,xix 7,a7 ,in general ,if the manufacturer of a drug or biological described in subparagraph 7,c71 7,e71 or 7,g7 of section #ahdb7o77#a7 or in section #ahha7;b77#ad77;,b7 that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection 7b7 of section #aibg1 for calendar quarters beginning with the second calendar quarter beginning on or after the date of the enactment of this paragraph1 such manufacturer shall report to the ,secretary the information described in subsection 7b77#c77;,a77iii7 of such section #aibg with respect to such drug or biological in a time and manner specified by the ,secretary4 ,for purposes of applying this paragraph1 a drug or biological described in the previous sentence includes items1 services1 supplies1 and products that are payable under this part as a drug or biological4 7,b7 ,audit ,information reported under subparagraph 7,a7 is subject to audit by the ,inspector ,general of the ,department of ,health and ,human ,services4 7,c7 ,verification ,the ,secretary may survey wholesalers and manufacturers that directly distribute drugs described in subparagraph 7,a71 when necessary1 to verify manufacturer prices and manufacturer's average sales prices 7including wholesale acquisition cost7 if required to make payment reported under subparagraph 7,a74 ,the ,secretary may impose a civil monetary penalty in an amount not to exceed #ajj1jjj on a wholesaler1 manufacturer1 or direct seller1 if the wholesaler1 manufacturer1 or direct seller of such a drug refuses a request for information about charges or prices by the ,secretary in connection with a survey under this subparagraph or knowingly provides false information4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7,d7 ,confidentiality ,notwithstanding any other provision of law1 information disclosed by manufacturers or wholesalers under this paragraph 7other than the wholesale acquisition cost for purposes of carrying out this section7 is confidential and shall not be disclosed by the ,secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler1 except-- 7i7 as the ,secretary determines to be necessary to carry out this section 7including the determination and implementation of the payment amount71 or to carry out section #ahdg;,b2 7ii7 to permit the ,comptroller ,general of the ,united ,states to review the information provided2 and 7iii7 to permit the ,director of the ,congressional ,budget ,office to review the information provided4 4 7b7 ,enforcement ,section #ahdg;,a of such ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is further amended-- 7#a7 in subsection 7d77#d7-- 7,a7 in subparagraph 7,a71 by striking ,in general and inserting ,misrepresentation2 7,b7 in subparagraph 7,b71 by striking subparagraph 7,b7 and inserting subparagraph 7,a71 7,b71 or 7,c72 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,d72 and 7,d7 by inserting after subparagraph 7,a7 the following new subparagraphs3 7,b7 ,failure to provide timely information ,if the ,secretary determines that a manufacturer described in subsection 7f77#b7 has failed to report on information described in section #aibg7;b77#c77;,a77iii7 with respect to a drug or biological in accordance with such subsection1 the ,secretary shall apply a civil money penalty in an amount of #aj1jjj for each day the manufacturer has failed to report such information and such amount shall be paid to the ,treasury4 7,c7 ,false information ,any manufacturer required to submit information under subsection 7f77#b7 that knowingly provides false information is subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalties are in addition to other penalties as may be prescribed by law4 2 and 7#b7 in subsection 7c77#f77;,a71 by striking the period at the end and inserting 1 except that1 for purposes of subsection 7f77#b71 the ,secretary may1 if the ,secretary determines appropriate1 exclude repackagers of a drug or biological from such term44 7c7 ,manufacturers with a rebate agreement 7#a7 ,in general ,section #aibg7;b77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is amended by adding at the end the following new sentence3 ,for purposes of applying clause 7iii71 a drug or biological described in the flush matter following such clause includes items1 services1 supplies1 and products that are payable under this part as a drug or biological44 7#b7 ,technical amendment ,section #aibg7;b77#c77;,a77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is amended by striking section #ahha7;b77#ac77;,a77ii7 and inserting section #ahha7;b77#ad77;,b74 7d7 ,report ,not later than ,january #a1 #bjbc1 the ,inspector ,general of the ,department of ,health and ,human ,services shall assess and submit to ,congress a report on the accuracy of average sales price information submitted by manufacturers under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,such report shall include any recommendations on how to improve the accuracy of such information4 #d4 ,determination of budgetary effects ,the budgetary effects of this ,act1 for the purpose of complying with the ,statutory ,pay-,as-,you-,go ,act of #bjaj1 shall be determined by reference to the latest statement titled 8,budgetary ,effects of ,,paygo ,legislation0 for this ,act1 submitted for printing in the ,congressional ,record by the ,chairman of the ,house ,budget ,committee1 provided that such statement has been submitted prior to the vote on passage4 ,passed the ,house of ,representatives ,december #i1 #bjbj4;,clerk4